20
21
California Hospital
Survey Manual
A Guide to the Licensing & Certification Survey Process
Survey
January 2021
4th Edition
California Hospital
Survey Manual
A Guide to the Licensing and Certification Survey Process
Ordering Information
For more information, visit CHA online at www.calhospital.org/publications
CHA Publications
Several helpful publications are available through CHA including:
• California Health Information
Privacy Manual
• California Hospital Compliance Manual
• California Hospital Survey Manual —
A Guide to the Licensing & Certification
Survey Process
• Consent Manual
• Discharge Planning for Homeless Patients
• EMTALA — A Guide to Patient
Anti-Dumping Laws
• Healthcare Workplace Violence Prevention
• Managing High-Profile Patient Information
• Mental Health Law
• Model Medical Staff Bylaws & Rules
• Record and Data Retention Schedule
• The Cal/OSHA Safe Patient Handling
Regulation
This publication is designed to produce accurate and authoritative information with regard to the subject matter covered.
It is sold with the understanding that CHA is not engaged in rendering legal service. If legal or other expert assistance is
required, the services of a competent professional person should be sought.
© 2012, 2014, 2015, 2021 by the California Hospital Association
All rights reserved. Fourth edition 2021.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise (with the exception of state- or federally-generated forms or
appendices), without the prior written approval of:
California Hospital Association
ATTN: Publishing
1215 K Street, Suite 800
Sacramento, CA 95814
However, hospitals that are members of the California Hospital Association may use the Model Hospital Compliance Plan,
model forms, signs and handouts as templates in developing their own plan, forms, signs and handouts.
It is the intent of CHA to strictly enforce this copyright.
Published by the California Hospital Association.
Printed in the United States of America.
Liz Mekjavich, Vice President, Publishing and Education
Lois J. Richardson, Esq., Vice President and Legal Counsel
Bob Mion, Director, Publishing and Marketing
Emily Stone, Publishing Manager
Quick Reference Guide
PREFACE
WHERE TO FIND LAWS REFERENCED IN THE MANUAL
LIST OF ACRONYMS
APPENDIXES
Appendix HS-1 California Department of Public Health Organization Chart
Appendix HS-2 Adverse Events Reporting Requirement
Form 20-1 Adverse Event Report Form — Sample
Appendix HS-4 Unusual Occurrences Reporting Requirement
Appendix HS-5 State-2567: Statement of Deficiencies and
Plan of Correction
Appendix HS-6 Maximum Time Frames Related to the Federal On-Site
Investigation of Complaints/Incidents
Appendix HS-7 Form CMS-2567: Statement of Deficiencies and
Plan of Correction
Appendix HS-8 Timeline for 90-Day Termination Track
Appendix HS-9 Timeline for 23-Day Termination Track
Appendix HS-10 Sample Cover Letter for Hospital’s CMS-2567 Response
(for a CMS survey)
Appendix HS-11 Definitions of Hospitals Under California Law
Appendix HS-13 FAQs on Writing Hospital Policies and Procedures
Appendix HS-14 Instructions For Calculating an Administrative Penalty
Appendix HS-15 Federal vs. State Immediate Jeopardy Definition and
Implementation Comparison
INDEX
CHAPTERS
Chapter 1 Introduction and Background
Chapter 2 State Surveys
Chapter 3 Federal Surveys
Chapter 4 Tips for Achieving a Successful Survey
Chapter 5 After the Survey: Preparing the Plan of Correction
Preface
It is fitting that the release of this fourth edition of the California Hospital Survey Manual
coincides with the California Department of Public Health’s reorganization, modernization, and
performance improvement program — as well as heightened nationwide efforts to improve
patient safety and the quality of care in hospitals and other settings.
Now more than ever, hospitals, government agencies, payers, and other interested parties
are devoting significant resources to protect hospital patients from further illness or injury and
decrease or eliminate complications.
A key component of improved quality centers around compliance with governmental
requirements. Hospitals must expect and prepare for close scrutiny of patient care, as well
as transparency regarding errors, financial penalties when errors are made, and incentives for
providing quality care.
This manual focuses on licensing and certification surveys — the process that state and federal
government agencies use to ensure hospitals comply with the law, with the ultimate goal of
promoting high-quality patient care.
The California Hospital Survey Manual is intended to help hospital administrators prepare for
and understand the survey process, from start to finish. It is written specifically for California’s
hospital licensing and certification professionals, compliance officers, legal counsel, risk
managers, and other members of the hospital’s licensing and compliance teams. It is the
only hospital survey manual that is specific to California and explains both state and federal
requirements.
CHA is pleased to publish this manual as a service to our members and others and hope
you find it useful. If you have any comments or suggestions on how to improve the California
Hospital Survey Manual, please feel free to contact me by phone or email.
Lois J. Richardson, Esq.
Author, California Hospital Survey Manual
Vice President & Legal Counsel
California Hospital Association
(916) 552-7611
Information contained in the California Hospital Survey Manual should not be construed as legal advice or used to resolve
legal problems by health care facilities or practitioners without consulting legal counsel. A health care facility may want to
accept all or some of the California Hospital Survey Manual as part of its standard operating policy. If so, the hospital or
health facility’s legal counsel and its board of trustees/directors should review such policies.
Where to Find Laws
Referenced in the
Manual
All of the laws discussed in the California Hospital Survey Manual can be found on the Internet.
FEDERAL LAW
A federal statute is written by a United States Senator or Representative. It is voted on by the
United States Senate and the House of Representatives, and then signed by the President.
A federal statute is referenced like this: 42 U.S.C. Section 1395. “U.S.C.” stands for “United
States Code.” Federal statutes are found at www.govinfo.gov/app/collection/uscode or at
www.law.cornell.edu.
A federal regulation is written by a federal agency such as the U.S. Department of Health
and Human Services or the U.S. Food and Drug Administration. The proposed regulation is
published in the Federal Register, along with an explanation (called the “preamble”) of the
regulation, so that the general public and lobbyists may comment on it. The federal agency
must summarize and respond to each comment it receives on the proposed regulation. The
agency may or may not make changes to the proposed regulation based on the comments.
The final regulation is also published in the Federal Register. A federal regulation is referenced
like this: 42 C.F.R. Section 482.1 or 42 C.F.R. Part 2. “C.F.R.” stands for “Code of Federal
Regulations.” Federal regulations are found at www.ecfr.gov. The preamble, however, is only
published in the Federal Register and not in the Code of Federal Regulations. The Federal
Register is found at at www.federalregister.gov.
The Centers for Medicare & Medicaid Services (CMS) publishes its Interpretive Guidelines
on the Internet. The Interpretive Guidelines include information for surveyors on how CMS
interprets its regulations (the Conditions of Participation), and instructions for surveyors on how
to assess hospitals’ compliance with them. The Interpretive Guidelines are found at www.cms.
gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html (click on
Publication 100-07, “State Operations Manual, then “Appendicestoc” (short for “Appendices
Table of Contents”)). There are several appendices that hospitals will find useful, for example, A
(hospitals), V (EMTALA), and W (critical access hospitals).
A federal law must be obeyed throughout the United States, including in California, unless the
federal law expressly states otherwise. As a general rule, if a federal law conflicts with a state
law, the federal law prevails, unless the federal law expressly states otherwise.
If there is no conflict, such as when one law is stricter but they don’t actually conflict with
each other, both laws generally must be followed. For example, under the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), the federal law states that providers must
conform to whichever provision of federal or state law provides patients with greater privacy
protection or gives them greater access to their medical information.
STATE LAW
A state statute is written by a California Senator or Assembly Member. It is voted on by the
California Senate and Assembly, and then signed by the Governor. A state statute is referenced
like this: Civil Code Section 56 or Health and Safety Code Section 1250. State statutes are
found at www.leginfo.legislature.ca.gov. Proposed laws (Assembly Bills and Senate Bills) may
also be found at this website.
A state regulation is written by a state agency such as the California Department of Public
Health or the California Department of Managed Health Care. A short description of the
proposed regulation is published in the California Regulatory Notice Register, more commonly
called the Z Register, so that the general public and lobbyists may request a copy of the exact
text of the proposed regulation and comment on it. The state agency must summarize and
respond to each comment it receives on the proposed regulation. The agency may or may
not make changes to the proposed regulation based on the comments. A notice that the final
regulation has been officially adopted is also published in the Z Register. The Z Register is
found at oal.ca.gov/california_regulatory_notice_online.
A state regulation is referenced like this: Title 22, C.C.R., Section 70707. “C.C.R.” stands for
“California Code of Regulations.” State regulations are found at https://govt.westlaw.com/
calregs/search/index. The California Department of Public Health sometimes issues letters
explaining its regulations or processes; these All Facilities Letters are found at https://www.
cdph.ca.gov/programs/chcq/lcp/pages/lncafl.aspx.
A state law must be obeyed in California only. As a general rule, if a California law conflicts with
a federal law, the federal law prevails, unless the federal law expressly states otherwise. (If there
is no conflict, such as when one law is stricter but they don’t actually conflict with each other,
both laws generally must be followed.)
CHA California Hospital Survey Manual 2021
List of Acronyms
AFL All Facilities Letter (issued by CDPH)
ALJ Administrative Law Judge
AO Accreditation Organization
AOA American Osteopathic Association
APH Acute Psychiatric Hospital
CAB Centralized Applications Branch (part of CDPH)
CAH Critical Access Hospital
CDPH California Department of Public Health
CEO Chief Executive Officer
C.F.R. Code of Federal Regulations
CHA California Hospital Association
CHCQ Center for Health Care Quality (part of CDPH)
CHHS California Health and Human Services Agency
CIHQ Center for Improvement in Healthcare Quality
CLIA Clinical Laboratory Improvement Amendments of 1988
CMS Centers for Medicare & Medicaid Services
CoP Condition of Participation
DAB Departmental Appeals Board
ED Emergency Department
EMTALA Emergency Medical Treatment and Labor Act
EHR Electronic Health Record
ER Emergency Room
ERI Entity-reported Event
FAQs Frequently Asked Questions
FRI Facility-reported Event
GACH General Acute Care Hospital
HFAP Healthcare Facilities Accreditation Program
HFEN Health Facilities Evaluator Nurse
ICU Intensive Care Unit
IJ Immediate Jeopardy
IOM Internet-Only Manual (also Institute of Medicine)
LCA Licensing, Certification and Accreditation
L&C Licensing and Certification
LSC Life Safety Code
MRSA Methicillin-Resistant Staphylococcus Aureus
NF Nursing Facility
NFPA National Fire Prevention Association
OB Obstetrics
OR Operating Room
OSHA Occupational Safety and Health Administration
PoC Plan of Correction
PSO Patient Safety Organization
QAPI Quality Assessment and Performance Improvement
QSO Quality, Safety and Oversight
RO Regional Office (of CMS)
SA State Agency (CDPH in California)
SSA State Survey Agency (CDPH in California)
SNF Skilled Nursing Facility
SoD Statement of Deficiencies (2567)
SOM State Operations Manual
TJC The Joint Commission
VBP Value-Based Purchasing
CHA California Hospital Survey Manual 2021
1 Introduction and Background
Chapter 1 — Contents
©CALIFORNIA HOSPITAL ASSOCIATION
I. Introduction ......................................................................................................... 1.1
II. Background ......................................................................................................... 1.1
A. State Licensing ............................................................................................. 1.1
Types of Hospitals ........................................................................................... 1.1
Hospital Services ............................................................................................ 1.2
B. Federal Certification ..................................................................................... 1.2
C. Accreditation ................................................................................................ 1.4
D. Other ............................................................................................................. 1.4
1 Introduction and Background
1.1
©CALIFORNIA HOSPITAL ASSOCIATION
I. INTRODUCTION
The surveyors have arrived, unannounced, at your hospital. What do you do first? What will
the surveyors do?
This manual explains who the surveyors are, which laws they assess compliance with,
and how they conduct a survey. It also explains the different types of surveys and possible
outcomes of a survey: the statement of deficiencies, immediate jeopardy, fines, and the
Medicare/Medicaid termination process. You will find tips on:
1. How to prepare for surveys,
2. How to interact with the surveyors,
3. How to write plans of correction, and
4. How to appeal adverse actions.
Both state and federal surveys are described throughout the manual. Although the surveyors
may be the same people, there are differences in processes and potential outcomes. This
manual will help hospitals understand the differences.
II. BACKGROUND
A. State Licensing
Hospitals in California must obtain and maintain a license from the California Department
of Public Health (CDPH). CDPH’s Licensing and Certification (L&C) Program is responsible
for issuing the license and assessing a hospital’s compliance with state licensing laws
(see III.“Which Laws are State Surveyors Assessing Compliance With?,” page2.6, for
information about these laws). If CDPH determines that a hospital is not in compliance with
state licensing laws, it may require the hospital to complete a plan of correction, issue a
cease and desist order, close a unit or service, require a reduction in patients, prohibit new
admissions, and/or assess a fine against the hospital. CDPH may also suspend or revoke the
hospital’s license, a supplemental service approval, or a special permit.
Types of Hospitals
California law establishes three types of hospitals:
1. General acute care hospitals,
2. Acute psychiatric hospitals, and
3. Special hospitals.
The legal definitions for these hospitals are found in Appendix HS-11, “Definitions of Hospitals
Under California Law,” at the end of this manual.
The licensure category of “special” hospital is frequently confused with the term “specialty”
hospital. A special hospital is defined in state law as a facility that provides inpatient or
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©CALIFORNIA HOSPITAL ASSOCIATION
outpatient care in dentistry or maternity. There is no definition in state law for a specialty
hospital, which is typically a hospital that specializes in cardiac care or orthopaedic care. In
California, specialty hospitals are licensed as general acute care hospitals.
There is also no definition in California law for a critical access hospital, frontier hospital, or
sole community hospital. These are federal terms. These hospitals are licensed in California
as general acute care hospitals, and generally must comply with all requirements under state
law for general acute care hospitals.
Hospital Services
Hospitals must offer the following basic services: medical, nursing, surgical, anesthesia,
laboratory, radiology, pharmacy, and dietary (some hospitals are exempt from offering
surgical and anesthesia services). CDPH has a long list of supplemental services that
require special approval, such as cardiovascular surgery, cardiac catheterization, chronic
dialysis, emergency, coronary care, intensive care unit, nuclear medicine, occupational
therapy, outpatient, pediatrics, perinatal, psychiatric, social service, etc. The hospital’s
license lists the supplemental services the hospital is authorized to provide, including
locations and number/category of beds. If a hospital wishes to change any of these
services (such as the number, location or type of beds), the hospital must obtain CDPH
approval in advance. Hospitals work with CDPH’s Centralized Applications Branch (CAB)
in this regard. Hospitals should also work with CAB with regard to construction projects,
addition or replacement of imaging equipment, and similar endeavors., For more information
about CAB, including necessary forms and contact information, go to https://www.cdph.
ca.gov/Programs/CHCQ/LCP/Pages/ApplyForLicensure.aspx.
California hospitals are not required to have an emergency department, although most do.
B. Federal Certification
Hospitals are required to comply with the federal requirements set forth in the Medicare
regulations called the “Conditions of Participation” (CoPs), as well as EMTALA and other
requirements, in order to participate in the Medicare or Medicaid
1
programs (that is, to receive
payment for services rendered to Medicare or Medicaid patients). (See III.“Which Laws are
Federal Surveyors Assessing Compliance With?,” page3.3, for more information regarding
the CoPs.) The federal government agency that certifies compliance with these requirements
is the Centers for Medicare & Medicaid Services (CMS). CMS permits hospitals to become
certified in two ways:
1. Deemed status. A hospital that is accredited by a CMS-approved accreditation
organization is deemed to meet the CoPs. (The hospital must also complete the
standard CMS enrollment forms and initial certification processes.) To receive
approval from CMS to confer deemed status on hospitals, an accreditation
organization must demonstrate to CMS that the requirements hospitals must meet
to become accredited are equivalent to the CoPs. At this time, CMS has approved
the following accreditation organizations to confer deemed status on hospitals:
1 Medicare pays for health care services for most people over age 65, Social Security disability recipients, and
individuals needing renal dialysis or transplantation. Medicaid pays for health care services for specified low-income
individuals. The Medicaid program in California is called “Medi-Cal.” It is funded partially by the federal government,
which is why Medi-Cal participating providers must comply with federal certification requirements.
Chapter 1 — Introduction and Background CHA
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©CALIFORNIA HOSPITAL ASSOCIATION
a. The Joint Commission (TJC)
b. The Accreditation Association for Hospitals and Health Systems (AAHHS)
Healthcare Facilities Accreditation Program (HFAP)
c. DNV GL Healthcare
d. The Center for Improvement in Healthcare Quality (CIHQ)
It is important to note that accreditation organizations offer many types of programs.
If a hospital wishes deemed status for Medicare certification purposes, the hospital
must become accredited under the accreditation organization’s deemed status
program. The accreditation organization will provide a copy of its survey report,
indicate the date of accreditation, and recommend “deemed status” for the hospital.
When CMS approves participation in the Medicare/Medicaid programs, the hospital
is “deemed” to have met the applicable CoPs, and CMS will issue the hospital a
Medicare provider agreement. The hospital is then considered “certified” on the
basis of its deemed status. The hospital will need to be recertified periodically
by the accreditation organization to confirm that the hospital continues to meet
applicable requirements. A hospital that is accredited for Medicare participation
by an accreditation organization does not fall under the jurisdiction of the State
Survey Agency (which is CDPH in California) for recertification surveys. Instead,
the accreditation organization is responsible for oversight of the hospital’s ongoing
compliance with the CoPs, unless CMS directs CDPH to perform a validation survey
(see C.“Validation Survey,” page3.3). In addition, CDPH may perform a state or
federal complaint survey with respect to a hospital that is accredited by a deeming
organization (see B.“Complaint Survey,” page2.4 and B.“Complaint/Allegation
Survey,” page3.2).
2. Survey by State Survey Agency. In most states, including California, CMS has
contracted with the state government agency responsible for licensing hospitals
to assist in determining compliance with the federal Medicare and Medicaid
requirements (the CoPs). In California, the responsible state agency (called the
“State Survey Agency”) is CDPH. A hospital that is not accredited by a CMS-
approved accreditation organization, but wishes to participate in the Medicare or
Medicaid program, must submit an application to CMS. CMS will then direct CDPH
to perform a certification survey. CDPH will provide a recommendation to CMS,
which makes the final determination as to whether the hospital may participate in
the Medicare and Medicaid programs. (The federal government uses the terms
“State Agency” (SA) or “State Survey Agency” (SSA) interchangeably to refer to
CDPH and its counterparts in other states.)
When CMS approves participation in Medicare, it issues the hospital a Medicare provider
agreement, and the hospital is then considered “certified.”
CMS also has contracted with CDPH to perform:
1. Validation surveys of hospitals with deemed status. Thus, a hospital that is
accredited by TJC, HFAP, DNV GL Healthcare or CIHQ may be surveyed by CDPH
to determine whether the accreditation organization properly accredited the hospital
and whether the hospital is indeed in compliance with the CoPs.
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©CALIFORNIA HOSPITAL ASSOCIATION
2. Certification/Recertification surveys of hospitals without deemed status.
3. Complaint/Allegation surveys of any hospital.
(See II.“Types of Federal Surveys,” page3.2, for a discussion of the different types of
federal surveys.)
CDPH uses the same surveyors for both state and federal surveys (see B.“CDPH
Staffing/Surveyors,” page2.1).
When preparing for a survey, hospitals should be sure to check compliance with the
CoPs/Interpretive Guidelines (see III.“Which Laws are Federal Surveyors Assessing
Compliance With?,” page3.3) as well as the applicable accreditation organization
standards. If a hospital is found to be out of compliance with the CoPs, it will be required to
complete a plan of correction. If it fails to complete an acceptable plan of correction, it may
be terminated from the Medicare and Medicaid programs. (See V.“Federal Survey Outcome,”
page3.26, for detailed information about deficiencies, plans of correction, and penalties
for noncompliance.) In addition, if a hospital is found to be out of compliance with EMTALA
requirements, it may be subject to financial penalties (see C.“EMTALA,” page3.10).
C. Accreditation
A hospital may choose to be accredited by one or more accreditation organizations (AOs).
Accreditation is voluntary — think of it as an independent third party’s “gold seal of approval.”
Accreditation requires application to the AO as well as an inspection (a survey) to determine
whether the hospital meets the organization’s standards and requirements. These surveys are
performed by employees of the AO, not by CDPH surveyors. The hospital pays the AO for
the costs of the survey and related services.
AOs are private entities, not government agencies (although some may have a contract with
a government agency or may be approved by a government agency). Some AOs, such as
the organizations with deeming authority (TJC, HFAP, DNV GL Healthcare and CIHQ), may
survey the entire hospital. Other AOs may focus on just a part of hospital operations (for
example, the laboratory, home health agency, hospice, ambulatory surgical center, etc.).
Some of these organizations have deeming authority and others do not. If an accreditation
organization has deeming authority, it will provide information about survey findings and other
data directly to CMS.
Some managed care plans require a hospital to be accredited in order to be included in the
plan’s network of participating providers.
Each AO provides extensive manuals and other resources about its accreditation process
and requirements. This manual thus focuses on the state licensure and federal certification
survey processes rather than accreditation surveys.
D. Other
Besides the CDPH hospital license, a hospital may need licenses or permits from the
California Board of Pharmacy, CDPH Laboratory Field Services, CDPH Radiologic Health
Branch, the U.S. Drug Enforcement Administration, and other government agencies. These
licenses and permits are not discussed in this manual.
2 State Surveys
Chapter 2 — Contents
©CALIFORNIA HOSPITAL ASSOCIATION
I. CDPH/L&C Organizational Structure and Staffing .......................................... 2.1
A. CDPH Organizational Structure ................................................................... 2.1
B. CDPH Staffing/Surveyors ............................................................................ 2.1
Los Angeles County ....................................................................................... 2.3
II. Types of State Surveys ...................................................................................... 2.3
A. Relicensing Surveys ..................................................................................... 2.3
Survey Protocol .............................................................................................. 2.3
Resources ...................................................................................................... 2.4
B. Complaint Survey ......................................................................................... 2.4
C. Hospital Self-Report to CDPH: Privacy Breach, Adverse Event,
Unusual Occurrence .................................................................................... 2.5
Privacy Breach or Unusual Occurrence ........................................................... 2.5
Reportable Adverse Event .............................................................................. 2.5
III. Which Laws are State Surveyors Assessing Compliance With? .................... 2.6
A. Program Flexibility ....................................................................................... 2.6
B. Other Laws ................................................................................................... 2.7
IV. State Survey Process ......................................................................................... 2.8
A. Overview of Surveyors’ Procedures ............................................................ 2.8
V. State Survey Outcome........................................................................................ 2.9
A. No Deficiencies ............................................................................................ 2.9
B. Minor Deficiencies; No Penalties ................................................................ 2.9
C. Deficiencies Not Constituting Immediate Jeopardy; Possible
Penalties ..................................................................................................... 2.10
D. Deficiencies Constituting Immediate Jeopardy ........................................ 2.10
E. Deficiencies Posing an Immediate and Substantial Hazard to the
Health or Safety of Patients ....................................................................... 2.10
VI. State-2567: Statement of Deficiencies and Plan of Correction .................... 2.11
A. Plan of Correction ...................................................................................... 2.11
Hospital and CDPH Fail to Agree Upon Plan of Correction ............................ 2.11
Failure to Implement the Plan of Correction .................................................. 2.12
Legal Effect of Plan of Correction .................................................................. 2.12
B. Public Availability of State-2567 ................................................................ 2.12
CHA California Hospital Survey Manual 2021
Chapter 2 — Contents
©CALIFORNIA HOSPITAL ASSOCIATION
VII. State Administrative Penalties ........................................................................ 2.12
A. CDPH Process ............................................................................................ 2.13
Examples of State Immediate Jeopardy Citations ......................................... 2.13
CHA Catalog of Administrative Penalties ....................................................... 2.15
B. Administrative Penalties: Calculating the Amount .................................. 2.15
Background and Application ........................................................................ 2.15
Definitions .................................................................................................... 2.16
Calculating the Penalty: Deficiencies Unrelated to the Hospital Fair
Pricing Policies Law ...................................................................................... 2.16
Scope and Severity Matrix ............................................................................ 2.17
Calculating the Penalty: Deficiencies Related to the Hospital Fair
Pricing Policies Law ...................................................................................... 2.20
Other Factors Influencing the Penalty Amount .............................................. 2.22
C. Civil Penalties: Violation of State “Anti-Dumping” Laws .......................... 2.23
D. Administrative Penalties: Violations of Nurse-to-Patient Staffing
Ratios .......................................................................................................... 2.23
E. Administrative Penalties: Privacy Breaches .............................................. 2.24
F. Public Notice of Administrative Penalties .................................................. 2.25
G. Appealing a State Administrative Penalty ................................................ 2.25
2 State Surveys
2.1
©CALIFORNIA HOSPITAL ASSOCIATION
This chapter focuses on state surveys — surveys conducted by California Department
of Public Health (CDPH) surveyors according to state rules and assessing the hospital’s
compliance with state laws. This chapter describes CDPH’s organizational structure
and staffing, types of state surveys, pertinent state laws, an overview of the surveyors’
procedures, the Statement of Deficiencies and Plan of Correction, and administrative
penalties. (See chapter 3 regarding CDPH surveyors conducting federal surveys.)
I. CDPH/L&C ORGANIZATIONAL STRUCTURE AND STAFFING
A. CDPH Organizational Structure
An organization chart for CDPH is found at CHA Appendix HS-1 at the back of this
manual and at https://www.cdph.ca.gov/Programs/DO/CDPH%20Document%20
Library/CDPHOrgChart%20September%202020.pdf. This chart shows that CDPH is divided
into many different “centers,” “offices,” and other divisions. Missing from the chart is the
fact that the director of CDPH reports to the secretary of the California Health and Human
Services Agency (CHHS) who reports to the Governor.
The CDPH Licensing & Certification (L&C) Program is a part of the Center for Health Care
Quality. A much more detailed organization chart for CDPH is found at www.calhospital.
org/publication/california-hospital-survey-manual. This detailed chart shows the personnel in
the Sacramento headquarters and distrtict offices, who in Sacramento supervises the district
managers around the state, who manages various field offices, and who supervises the
various CDPH consultants on medical issues, dietary, pharmacy, and life safety. Staff names
and phone numbers are provided.
Although the main “headquarters” of CHHS and CDPH, and the executive management
team, are located in Sacramento, hospitals are most likely to interact with CDPH staff located
in the 14 district offices throughout the state. A list of the district offices, including their
management personnel, addresses, phone/fax numbers, and email addresses is found at
https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/DistrictOffices.aspx. Each district
office has a District Manager, two District Administrators, surveyors and support staff. CHA
recommends that hospital licensing and certification personnel proactively get to know the
CDPH staff in their local district office in advance of any particular issue or situation. The
district office is the place to start if a hospital has questions about licensing matters.
CDPH’s vision and mission statement may be found at https://www.cdph.ca.gov/Pages/
About.aspx. L&C is funded primarily by fees paid by health facilities ($760 per hospital bed
for 2020–2021) and by payments from the federal government (CMS) for providing federal
certification services. Additional general information about CDPH may be found at https://
www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/HealthCareFacilities.aspx.
B. CDPH Staffing/Surveyors
The district office personnel who are most likely to interact with hospital staff are called
“surveyors.” Surveyors conduct in-depth inspections of hospitals and other health facilities
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to determine compliance with state licensing requirements and federal certification
requirements. (Federal surveys are performed by state surveyors as a result of a
contract between the state and federal governments.) Surveyors also conduct complaint
investigations, investigations of facility-reported events, and follow-up inspections. (See
II.“Types of State Surveys,” page2.3, and II.“Types of Federal Surveys,” page3.2, for
more information about the various types of inspections that may be conducted.) An on-site
inspection is called a “survey.”
CDPH employs more than 600 surveyors, 50 consultants, and 374 managers and support
staff throughout the state. CDPH often uses teams, rather than individuals, to survey
hospitals. Teams consist primarily of surveyors with the title of “Health Facilities Evaluator
Nurse” (HFEN) and “Consultant.” These surveyors are responsible for surveying skilled
nursing facilities, home health agencies, chronic dialysis clinics, ambulatory surgical centers,
clinics, intermediate care facilities, hospices, birthing centers, etc. — they do not spend all
of their time on acute care hospitals. CDPH’s Health Facility License Fees Annual Report,
found at https://www.cdph.ca.gov/Programs/CHCQ/LCP/CDPH%20Document%20
Library/CHCQ%202020-21%20Annual%20Fee%20Report_Final.pdf provides interesting
information on types of facilities surveyed, hours spent per facility type, etc.
CDPH uses the same surveyors for both state and federal surveys. Although the
surveyors may be the same people, there are differences in processes and potential
outcomes, as described throughout this manual. To make matters more confusing,
surveyors may figuratively “switch hats” while in the hospital. For example, CDPH
may receive a self-report of an adverse event and begin a state survey. If the
surveyors detect noncompliance with a federal requirement, they may call CMS while
still at the hospital and request authorization to conduct a federal survey on behalf of
CMS.
Hospitals should seek clarification from the surveyors if it is not clear whether they
are representing the state or CMS. Hospital should also clarify what type of survey
will take place (See II.“Types of State Surveys,” page2.3, and II.“Types of Federal
Surveys,” page3.2).
HFENs are registered nurses with at least one year of professional nursing experience. This
nursing experience must include at least six months of administrative responsibility (for
example, charge nurse, shift supervisor, nurse manager, director of staff development, or
teaching experience in nursing education). Alternatively, a Bachelor of Science in Nursing may
be substituted for the required administrative experience. Once hired, HFENs receive new
surveyor orientation including didactic instruction and field training, one-week federal basic
surveyor training, and specialty surveyor training.
HFENs are often assisted by other health professional surveyors, such as pharmacists,
dieticians, physicians, registered health information administrators, etc. These personnel have
titles such as “Pharmacy Consultant,” “Medical Consultant,” “Medical Records Consultant,”
etc.
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The size and composition of the survey team depend upon the type of survey to be
conducted, the size of the facility, the complexity of services offered, whether the facility has
a historical pattern of serious deficiencies or complaints, and whether new surveyors are
accompanying the team as part of their training. A survey may last for just a few hours or
may last for several days, depending upon the reason for the survey.
Los Angeles County
CDPH contracts with the Los Angeles County Department of Health Services to have county
employees perform state and federal surveys for hospitals located in Los Angeles County.
Hospitals located in Los Angeles County pay an extra $157 per bed annual license fee.
Hospitals owned by Los Angeles County, however, are surveyed by CDPH employees located
in the Orange County district office. [Health and Safety Code Section 1257]
II. TYPES OF STATE SURVEYS
A. Relicensing Surveys
After a hospital is initially licensed, CDPH is required by law to periodically survey hospitals to
ensure compliance with state licensing laws. These are called “relicensing” surveys.
These periodic inspections are called “relicensing surveys.” CDPH plans to perform a
relicensing survey for each hospital at least every three years, and more often as necessary to
ensure quality of care.
Survey Protocol
Surveys will be unannounced and will follow the general steps outlined in IV.“Federal
Survey Process,” page3.13 (entrance conference, information gathering/investigation,
exit conference, etc.). The survey team will include a registered nurse who is the team
coordinator, pharmaceutical consultant, nutrition consultant, medical consultant and 1–3
additional registered nurses, depending on the hospital size and the experience of the team
coordinator. The team may include others based on the size of the hospital, its compliance
history, number and complexity of approved supplemental services, distance of locations that
will be visited, and subject matter expertise of the team members. The medical and nutritional
consultants may be onsite or remote.
The surveyors will select patients to follow through hospital settings: preanesthesia, surgery,
recovery, radiology/imaging, etc. The patient selections are intended to represent a cross-
section of the patient population and services provided by the hospital. A total sample size
will consist of 6–10% of the current inpatient census with a minimum of 30 patients. The
surveyors will select patients who are in the facility during the time of the survey where
possible, so they can conduct a patient-focused survey and validate the information obtained
through observations, record reviews, and interviews with patient/staff/family.
Surveyors will interview patients to determine if they understand their medical condition,
reason for hospital admission, and their plan of care. For example, a surgical patient may be
asked about the process for surgery preparation, his or her knowledge of and consent for the
procedure, pre-operative patient teaching, post-operative patient goals and discharge plan.
Patients may also be asked about their knowledge of patient rights, advance directives, and
the hospital’s grievance/complaint procedure.
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Surveyors will review nursing units and procedures (including compliance with nurse-to-
patient ratio requirements), pharmacy, emergency department, surgery, dietary, infection
control and antimicrobial stewardship, complex outpatient care units, and other areas. While
preparing for the survey, the surveyors will have developed a list of concerns based on the
hospital’s past three years of deficiencies. The surveyors will check up on these areas also.
The surveyors will review program flexes, and make sure their list of your hospital’s approved
flexes matches your list.
Resources
CDPH has created a web page with information about the Relicensing Surveys at https://
www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/GeneralAcuteCareRelicensingSurvey.aspx.
This web page includes information about the survey process, a list of Title 22 regulations
and what surveyors are looking for in assessing compliance with each, survey time lines;
medication pass worksheets for surveyors to use; lists of documents that hospitals will
be asked to produce at the beginning of a relicensing survey; and an evaluation form that
hospitals are asked to complete after the survey.
In addition, CDPH has created a web page on healthcare associated infections and
antimicrobial stewardship that may be found at https://www.cdph.ca.gov/Programs/
CHCQ/HAI/Pages/HAIProgramHome.aspx. CDPH has indicated that it is particularly
interested in evaluating hospitals’ compliance with appropriate infection control measures
and the law mandating that hospitals implement antimicrobial stewardship programs.
B. Complaint Survey
CDPH is required by state law to make an on-site inspection or investigation whenever it
receives a complaint indicating an ongoing threat of imminent danger of death or serious
bodily harm to a patient. For purposes of this law, a “complaint” means any oral or written
notice from any person to CDPH (other than an adverse event report made by the hospital) of
an alleged violation of any applicable state or federal law, or an allegation of facts that might
constitute such a violation.
The on-site inspection or investigation must take place within 48 hours or two business days
(whichever is greater) after receipt of the complaint. The investigation must be completed
within 45 days. If CDPH does not meet this time frame, it must provide written notice to the
facility and the complainant (if any) of the basis for the extenuating circumstances preventing
it from meeting the time frame, and the anticipated completion date.
If CDPH receives a complaint but determines from the information available that there is no
threat of imminent danger of death or serious bodily harm to that patient or other patients,
no on-site inspection is required, but an investigation (by document review and/or phone
interviews) must be undertaken and completed within 45 days. If CDPH does not meet this
time frame, it must provide written notice to the facility and the complainant (if any) of the
basis for the extenuating circumstances preventing it from meeting the time frame, and the
anticipated completion date.
CDPH does not always adhere to these time frames due to workload issues. CDPH
sometimes saves lowest-level complaints to investigate the next time it visits the facility.
CDPH must notify the hospital and complainant in writing of its determination as a result of its
investigation. [Health and Safety Code Section 1279.2]
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C. Hospital Self-Report to CDPH: Privacy Breach, Adverse Event, Unusual
Occurrence
Hospitals are required to report to CDPH regarding specified adverse events, privacy
breaches, and unusual occurrences. The details of these reporting requirements are
described in CHA Appendix HS-2, “Adverse Event Reporting Requirement,” CHA’s California
Health Information Privacy Manual, and CHA Appendix HS-4, “Unusual Occurrences
Reporting Requirement.” The appendices are found in the back of this manual.
A hospital that reports an adverse event, privacy breach or unusual occurrence to CDPH
should immediately convene key people to begin the root cause analysis of the problem,
identify immediate corrective action to be taken, and prepare for a CDPH survey or other
CDPH action (document request, phone interviews, etc.). It is not a good idea to wait until
CDPH contacts the hospital to begin the corrective action process. All steps taken should be
documented.
Privacy Breach or Unusual Occurrence
CDPH is not required by law to respond in any particular manner to hospital reports of
privacy breaches or unusual occurrences. A CDPH surveyor may call the hospital, may ask
for additional information or documentation, or may visit the hospital to perform a formal or
informal survey. Or, CDPH may put the self-report in the hospital’s file to investigate during
its next survey. CDPH will use its judgment depending upon the nature of the reported event.
(See Health and Safety Code Section 1280.15 regarding privacy breaches and Title 22,
California Code of Regulations, Section 70737 (general acute care hospitals) or 71535 (acute
psychiatric hospitals) regarding unusual occurences.)
Reportable Adverse Event
CDPH is required by law to make an on-site inspection or investigation whenever it receives
an adverse event report indicating an ongoing threat of imminent danger of death or serious
bodily harm. This on-site inspection or investigation must take place within 48 hours or
two business days (whichever is greater) after receipt of the report. The law requires that
the investigation be completed within 45 days; however, hospitals often do not receive the
results of the investigation within this time frame. If CDPH does not meet this time frame,
it must provide written notice to the facility and the complainant (if any) of the basis for the
extenuating circumstances preventing it from meeting the time frame, and the anticipated
completion date. Until CDPH determines by on-site inspection that the adverse event has
been resolved, CDPH must conduct an unannounced inspection at least once per year of
any hospital that has reported an adverse event.
If CDPH receives an adverse event report but determines from the information available that
there is no threat of imminent danger of death or serious bodily harm to that patient or other
patients, no on-site inspection is required, but an investigation (by document review and/or
phone interview) must be undertaken and completed within 45 days. If CDPH does not meet
this time frame, it must provide written notice to the facility and the complainant (if any) of the
basis for the extenuating circumstances preventing it from meeting the time frame, and the
anticipated completion date.
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CDPH will check to see that the hospital informed the patient or patient’s legal representative
of the adverse event by the time the hospital reported to CDPH. Hospitals should take care
to make this notification in a timely manner and to document it.
CDPH must notify the hospital in writing of its determination as a result of its investigation.
[Health and Safety Code Sections 1279.1–1279.3]
III. WHICH LAWS ARE STATE SURVEYORS ASSESSING COMPLIANCE
WITH?
Surveyors who are conducting a state survey will assess the hospital’s compliance with
state statutes and regulations. The majority of the hospital licensing statutes are found in
the California Health and Safety Code, starting at Section 1250. The majority of the hospital
licensing regulations are found in Title 22 of the California Code of Regulations, starting at
Section 70001. (See “Where to Find Laws Referenced in the Manual” at the beginning of the
manual, for a discussion about the difference between a statute and a regulation and where
the exact text of these laws may be found on the Internet.)
In addition, many Title 22 regulations require that the hospital develop and implement
specified policies and procedures (for example, regarding nursing services, the surgical
service, the anesthesia service, laboratory, radiology, etc.). CDPH may cite a deficiency if the
hospital does not comply with its own policies and procedures, even if the policies contain
requirements that would not otherwise legally be required. In other words, if a hospital’s
policies specify procedures or actions that are not required by law, the hospital may be cited
by CDPH for failure to follow them. Hospitals should therefore be careful to tailor their policies
to the requirements of the law to the extent possible. (See Appendix HS-13, “FAQs on
Writing Hospital Policies and Procedures.”)
CDPH may cite a deficiency if the hospital does not comply with its own policies and
procedures, even if the policies contain requirements that would not otherwise legally
be required.
CDPH also publishes “All Facilities Letters” (AFLs) to provide guidance to hospitals regarding
new or amended laws, new or revised programs and processes, and other information. AFLs
may be found at https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/LNCAFL.aspx by
year of publication. Hospitals should check this web page frequently for newly issued letters.
Alternatively, hospital staff may register for the California Health Alert Network (CAHAN) email
list by emailing [email protected]. AFLs are distributed through the CAHAN email
system.
A. Program Flexibility
While hospitals generally must maintain continuous compliance with Title 22 regulations,
CDPH has the authority to grant flexibility from these regulatory requirements if the hospital
demonstrates its ability to meet statutory requirements (that is, Health and Safety Code
provisions). This is called “program flexibility.” CDPH cannot provide flexibility with respect
to statutory requirements in the absence of a Governor’s Executive Order (for example, in a
disaster).
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A hospital that is interested in obtaining a program flex should discuss its situation with
its local CDPH district office. Following these discussions, the hospital should complete
and submit the CDPH 5000 form to its district office, explaining why a variance of
one or more of the licensing requirements is appropriate under the circumstances.
(Form CDPH 5000 is found at https://www.cdph.ca.gov/CDPH%20Document%20
Library/ControlledForms/cdph5000.pdf.) The form must contain:
1. Each Title 22 regulation for which the facility requests flexibility.
2. An explanation of the alternative concepts, methods, procedures, techniques,
equipment, personnel qualifications, or pilot projects the facility proposes to use.
3. Supporting evidence demonstrating how the facility’s alternative concepts,
methods, procedures, techniques, equipment, personnel qualifications, or pilot
projects meet the intent of the regulation.
4. An authorized facility representative signature on all forms and/or requests.
If the district office determines the program flex request is incomplete, it will request
additional information or supporting documentation. Upon receipt of a completed request,
the district office will review it and may conduct an on-site inspection. The district office may
identify terms and conditions under which the exception or flexibility is granted. In addition,
the district office will determine an appropriate expiration date. Although older flexes may
not include an expiration date, CDPH’s eventual goal is for every approved program flex
to specify an expiration date. Hospitals may request renewals when the expiration date is
imminent.
Hospitals are required to post the program flex approval in the hospital, next to the hospital
license. Alternatively, hospitals may keep their flex approvals in a binder, and post a sign next
to the license advising viewers where the flex approvals are located and available for review.
If a hospital fails to comply with the terms and conditions of a program flex, or CDPH
determines it does not adequately protect patient safety, CDPH may revoke it. CDPH will
review all approved program flexes during the relicensing survey.
[Health and Safety Code Section 1276; Title 22, California Code of Regulations, Sections
70129, 70307 and 70363; All Facilities Letter 18-19, dated May 2, 2018]
CDPH has a different form for hospitals to use when requesting a program flex due to a
pandemic or other disaster. This form is the CDPH 5000 A, found at https://www.cdph.
ca.gov/CDPH%20Document%20Library/ControlledForms/cdph5000a.pdf. The hospital
must submit the completed 5000A form to CDPH’s Medical and Health Coordination Center
(MHCC) at chcqdutyoffi[email protected]. (See also All Facilities Letter 18-09, dated Jan. 12,
2018.)
B. Other Laws
There are many laws that hospitals must follow that CDPH is not required to, and does not,
enforce. For example, CDPH is not responsible for assessing a hospital’s compliance with
occupational safety and health requirements (a Cal/OSHA responsibility) or wage and hour
laws (a Department of Labor/Department of Industrial Relations responsibility). Therefore,
CDPH surveyors will not focus on these areas. However, they may notify the Medicare
Administrative Contractor, the CMS Regional Office, or another responsible government
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agency if they detect a problem outside their area of responsibility, especially if fraud or abuse
is suspected. They may also notify law enforcement if patient abuse or narcotics diversion is
suspected.
IV. STATE SURVEY PROCESS
CDPH surveyors will assess the hospital’s compliance with state licensing laws for all
services, areas and locations listed on the hospital’s license. This may include inpatient and
outpatient services, both on- and off-campus. The surveyors will accomplish this through
observations, interviews and document/record review.
Although surveys generally occur during daytime working hours (Monday through Friday),
surveyors may conduct a survey at any time, including evening and weekends. All surveys
are unannounced. A hospital may not refuse to allow access to the building and premises
to a CDPH surveyor [Health and Safety Code Section 1278; Title 22, California Code of
Regulations, Sections 70101 (general acute care hospitals) and 71101 (acute psychiatric
hospitals)]. (The laws discussed in this manual regarding the state survey process may be
found at Health and Safety Code Sections 1278 to 1282.)
Before the survey team arrives at the hospital, they will have familiarized themselves with
the hospital’s ownership, physical plant, previous survey results, waivers and variances that
exist, types of services offered, media reports, the hospital’s website, complaints and other
information.
A. Overview of Surveyors’ Procedures
The survey process, in general, consists of an entrance conference, observations by the
surveyor(s) (including document review and interviews), and an exit conference. After the exit
conference, the hospital will develop preliminary corrective action steps based on findings
communicated by the surveyors at the exit conference, while the surveyors are writing up
their survey findings on the State-2567 (“Statement of Deficiencies and Plan of Correction”)
form. After the hospital receives its 2567 form, the hospital will prepare and submit its formal
plan of correction. Finally, the surveyors may return to the hospital to verify that the plan of
correction was implemented. Information about these steps in the survey process is provided
in this chapter as well as in chapters 3 and 5.
In many parts of this manual, the most extensive type of survey is described — a full state
licensure or federal certification or validation survey, which can be a week-long (or longer)
experience with multiple surveyors in the facility at the same time, with potentially serious
consequences. The hospital will need to devote significant high-level staff time responding to
this type of survey. However, many surveys will be abbreviated versions of those described
in this manual. For example, if a hospital self-reports to CDPH a privacy breach wherein a
respiratory therapist faxed a pulmonary function test to the local bank instead of the ordering
physician’s office because the physician provided an incorrect fax number, CDPH will not
send multiple surveyors to the hospital for several days to investigate the entire facility. There
will not be a formal entrance conference and formal exit conference, and the hospital will not
want to convene an entire survey response team and record the “exit conference.” Such a
response would be excessive. Instead, CDPH may simply request the hospital’s policy and
procedure regarding the faxing of medical information and speak to the hospital’s privacy
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officer over the phone. Alternatively, a surveyor may investigate the privacy breach the next
time he or she makes an on-site visit.
Hospitals should bear in mind that the information presented in this manual is written
with the most extensive types of surveys in mind. They should adjust their response
and procedure appropriately when responding to less extensive surveys.
The entrance conference, surveyors’ procedures and exit conference for a state survey
are substantially the same as for a federal survey. The surveyors are not required to adhere
to the State Operations Manual, which was written by the federal government for federal
surveys, unless they are surveying for compliance with state law at the same time as a
federal inspection [Health and Safety Code Section 1279(g)]. (See B.“Entrance Conference,”
page3.13, C.“Surveyors’ Procedures,” page3.16, and E.“Exit Conference,” page3.24,
regarding these steps in the federal survey process.) As a practical matter, however,
the surveyors usually do follow the State Operations Manual; they will also follow the
requirements described in II.“Types of State Surveys,” page2.3, and III.“Which Laws are
State Surveyors Assessing Compliance With?,” page2.6.
V. STATE SURVEY OUTCOME
There are several possible state survey outcomes:
1. No deficiencies.
2. Minor deficiencies; no penalties.
3. Deficiencies not constituting an immediate jeopardy (IJ) to the health or safety of a
patient; possible penalties.
4. Deficiencies constituting IJs.
5. Deficiencies posing an immediate and substantial hazard to the health or safety of
patients.
Each is described below. NOTE: Although the law uses two somewhat different terms
(“immediate jeopardy” and “immediate and substantial hazard to the health or safety of
patients”), as a matter of practicality, both of these terms may apply to the same situations.
Neither term has been interpreted further by CDPH or the courts.
A. No Deficiencies
Obviously, having no deficiencies is the best possible outcome. The hospital is then done
with the survey process — congratulations!
B. Minor Deficiencies; No Penalties
If a CDPH survey finds noncompliance with state licensing requirements, but does not find
any deficiencies that it is considering levying an administrative penalty for, the surveyors will
return to their district office and prepare a “Statement of Deficiencies” (State-2567). The
hospital should receive it within 10 days.
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C. Deficiencies Not Constituting Immediate Jeopardy; Possible Penalties
If a CDPH survey finds noncompliance with state licensing requirements, but does not find
any deficiencies that constitute an immediate jeopardy (IJ) to the health or safety of a patient,
the surveyors will return to their district office and prepare a “Statement of Deficiencies”
(State-2567). The hospital should receive it within 30 days.
D. Deficiencies Constituting Immediate Jeopardy
If a CDPH surveyor determines that a hospital’s noncompliance with one or more state
licensure requirements constitutes (or constituted) an immediate jeopardy to the health or
safety of a patient, CDPH follows a slightly different procedure.
Under state law, “immediate jeopardy” means a situation in which the licensee’s (the
hospital’s) noncompliance with one or more requirements of licensure has caused, or is
likely to cause, serious injury or death to a patient [Health and Safety Code Section 1280.1].
(Federal law is somewhat different; see E.“Immediate Jeopardy (Federal),” page3.27, for
more information about federal IJs).
Upon discovering an IJ, the on-site surveyor is required to consult a supervisor. If the
supervisor agrees that the deficiency constitutes an IJ, the surveyor will immediately notify
hospital administration that an IJ exists and immediately obtain a plan of correction. During
the exit conference, the surveyor and/or supervisor will reaffirm that an IJ exists and that an
administrative penalty may be issued at a later date. The surveyors will return to their district
office and prepare two “Statement of Deficiencies” (State-2567) forms. One form will reflect
the IJ; CDPH has not committed to a specific time frame in which the hospital will receive this
document. The rest of the deficiencies will be noted on a separate 2567, which the hospital
will receive within 30 days.
CDPH states that a deficiency may be considered an “immediate jeopardy” if the deficiency
caused, or was likely to cause, serious injury or death to a patient at the time it occurred.
This is true even if CDPH does not learn about the deficiency or incident until months later,
and even if the hospital corrected the situation long before CDPH investigated. A hospital
may have a deficiency, correct it, have no related problems, and then months later find out
that CDPH considers it an “immediate jeopardy” and has issued a penalty (see CDPH FAQs
at https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/AP_FAQ.aspx. This is not the
case for federal IJs (see E.“Immediate Jeopardy (Federal),” page3.27). CHA has created
a chart showing the differences between state and federal IJs; it may be found at the end
of this manual as Appendix HS-15, “Federal vs. State Immediate Jeopardy Definition and
Implementation Comparison.” The California Hospital Association believes that CDPH’s
interpretation of the law in this respect is incorrect; however, hospitals should be aware of
CDPH’s legal interpretation.
E. Deficiencies Posing an Immediate and Substantial Hazard to the Health or
Safety of Patients
If a deficiency poses an immediate and substantial hazard to the health or safety of patients,
CDPH may order either of the following until the hazardous condition is corrected:
1. Reduction in the number of patients.
2. Closure of the unit or units within the hospital that pose the risk.
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The hospital may appeal such an order to the superior court of the county in which the
hospital is located.
[Health and Safety Code Section 1280]
VI. STATE-2567: STATEMENT OF DEFICIENCIES AND PLAN OF
CORRECTION
CDPH uses a form called the “State-2567” to record deficiencies (noncompliance)
identified during a survey. The State-2567 is almost identical to the Form CMS-2567
(seeVI.“The Form CMS-2567: Statement of Deficiencies and Plan of Correction,”
page3.30). A copy of the State-2567 is found at the back of this manual as CHA
Appendix HS-5. Examples of completed State-2567s may be found at https://www.cdph.
ca.gov/Programs/CHCQ/LCP/Pages/Hospital-Administrative-Penalties-by-Year.aspx.
After the survey, the surveyors will complete the surveyor’s portion of the State-2567. The
State-2567 is the record of the survey where the survey team documents and justifies its
determination of noncompliance. The State-2567 will list, in the two left-hand columns, all of
the deficiencies found by the surveyors during the survey. Deficiencies may be addressed by
a number (such as “E 242”) in the very left-hand column, or this column may be left blank.
(The “E” code refers to a CDPH indexing system and is not relevant or useful for hospitals.)
The next column will contain the Title 22 provision or the Health and Safety Code provision
that was not met and a detailed description of the findings. CDPH will frequently use the
Title 22 or Health and Safety Code section number only. A number like “70215” — that is,
five digits starting with a “7”— refers to Title 22. A number like “1280.1” — that is, four digits
before the decimal point, starting with a “12” — refers to the Health and Safety Code. Each
surveyor will draft his or her section of the 2567, so the style and detail may vary within
the document. (See III.“Which Laws are State Surveyors Assessing Compliance With?,”
page2.6, for more information regarding Title 22 and the Health and Safety Code.)
The third, fourth and fifth columns of the State-2567 are blank when the hospital receives it.
A. Plan of Correction
As mentioned above, the fourth column of the State-2567 is titled “Provider’s Plan of
Correction” (PoC) and is blank when the hospital receives it. The hospital will complete this
portion of the State-2567 and submit it to CDPH (separate sheets of paper may be used).
The law states that “the health facility shall agree with [CDPH] upon a plan of correction
that shall give the health facility a reasonable time to correct” deficiencies identified on the
State-2567 [Health and Safety Code Section 1280]. As a practical matter, CDPH will either
approve or disapprove the hospital’s PoC. If it is disapproved, the hospital must revise and
resubmit it until CDPH approves it.
(See IV.“Drafting the Hospital’s Final 2567 Response and PoC,” page5.7, for more
information on preparing the hospital’s response.)
Hospital and CDPH Fail to Agree Upon Plan of Correction
If the hospital fails to submit an acceptable plan of correction within a reasonable time, and if
the deficiency poses an immediate and substantial hazard to the health or safety of patients,
CDPH may take action to order implementation of a plan of correction devised by CDPH. The
order must be in writing and must contain a statement of the reasons for the order.
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If the hospital does not agree that the deficiency poses an immediate and substantial hazard
to the health or safety of patients or if the hospital believes that the plan of correction will
not correct the hazard, or if the hospital proposes a more efficient or effective means of
remedying the deficiency, the hospital may, within 10 days of receiving the plan of correction
from CDPH, appeal the order to the director of CDPH. The director must review information
provided by the hospital, CDPH, and other affected parties and within a reasonable time
render a decision in writing that must include a statement of reasons for the order. While
the director is reviewing the appeal, the order to implement the plan of correction must be
stayed. This appeal is not an adjudicative hearing and is not required to comply with the
adjudicative hearing process set forth in Health and Safety Code Section 100171.
[Health and Safety Code Section 1280]
Failure to Implement the Plan of Correction
If the hospital fails to implement, within a reasonable time period, a plan of correction that
was accepted by CDPH, CDPH may order implementation of it. A hospital should assume its
PoC has been accepted by CDPH (and should thus work to implement it), unless and until it
is rejected by CDPH. CDPH does not always inform the hospital that its PoC is acceptable –
the hospital should check with CDPH if it hasn’t heard back in a reasonable time period.
If CDPH conducts a survey and determines that a hospital failed to correct the deficiencies
as indicated in the plan of correction, CDPH will issue another 2567 or, in unusual
circumstances, CDPH may take action to revoke or suspend the deficient service or the
hospital’s license. [Health and Safety Code Section 1280] In addition, CDPH may suspend
or revoke a supplemental service approval or a special permit [Title 22, California Code of
Regulations, Sections 70309 and 70369].
Legal Effect of Plan of Correction
The act of providing a plan of correction, the content of the plan of correction, and the
execution of a plan of correction, may not be used in any legal action or administrative
proceeding as an admission (within the meaning of Evidence Code Sections 1220 to 1227)
against the hospital, its licensee or its personnel. [Health and Safety Code Section 1280]
In other words, the fact that the hospital submits a plan of correction does not mean the
hospital is admitting it was noncompliant. A hospital may deny that it was noncompliant in
court, despite having submitted a plan of correction.
B. Public Availability of State-2567
The Statement of Deficiencies portion of the State-2567is posted online at https://www.
cdph.ca.gov/programs/chcq/lcp/calhealthfind/pages/home.aspx when CDPH has received
verification that the hospital has received it from CDPH. The Plan of Correction portion
is available for public inspection upon receipt by CDPH.. The public (including attorneys,
newspapers, labor unions, etc.) may obtain 2567s by sending a Public Records Act request
to CDPH. (See also F.“Public Notice of Administrative Penalties,” page2.25.)
VII. STATE ADMINISTRATIVE PENALTIES
CDPH may issue administrative penalties against hospitals for violations of licensing
requirements that have been cited by surveyors on a State-2567. [Title 22, California Code of
Regulations, Sections 70951 and 71702]
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A. CDPH Process
The recommendation to issue an administrative penalty for a violation of a licensing
requirement that constitutes an IJ is made at the district office level by the investigating
surveyor and his or her supervisor. The recommended penalties are sent to the CDPH
Office of Legal Services and to the Licensing and Certification Program deputy director
in Sacramento for approval and issuance. The deputy director makes the final decision
regarding whether a penalty is assessed and if so, the amount of the penalty. Hospitals
should be aware that both the state and the federal governments use the term “immediate
jeopardy” and define it similarly. However, the process and interpretations differ. (See also
E.“Immediate Jeopardy (Federal),” page3.27, and Appendix HS-15, “Federal vs. State
Immediate Jeopardy Definition and Implementation Comparison.”)
CDPH has full discretion to consider all factors when determining the amount of an
administrative penalty. CDPH is required to consider the special circumstances of small and
rural hospitals (as defined in Health and Safety Code Section 124840) in order to protect
access to quality care in those hospitals.
Hospitals may appeal penalty assessments imposed by CDPH (see G.“Appealing a State
Administrative Penalty,” page2.25).
Examples of State Immediate Jeopardy Citations
CDPH has not published any regulations or specific descriptions of what types of
noncompliance will trigger particular penalties.
Administrative penalties may arise from reportable adverse events, but an administrative
penalty also may be issued for a deficiency that is not a reportable adverse event. For
example, serving contaminated food to a patient may constitute an immediate jeopardy
and be subject to an administrative penalty, but it is not in the list of reportable adverse
events found in Health and Safety Code Section 1279.1. (However, this situation may be
reportable under the “unusual occurrence” reporting requirement of Title 22, California Code
of Regulations, Sections 70737 (general acute care hospitals) and 71535 (acute psychiatric
hospitals).) In addition, a reportable adverse event often does not result in an administrative
penalty.
Some of the immediate jeopardy violations for which CDPH has issued administrative
penalties in the past include, but are not limited to, a hospital’s:
1. Failure to develop and implement policies and procedures for the safe and effective
administration of medications known to cause cardiac arrhythmias (in particular
those with a black box warning);
2. Failure to develop and implement policies and procedures to ensure safe food-
handling practices;
3. Failure to provide pharmaceutical services that would meet the needs of all patients
by failing to develop and implement policies and procedures related to the use
of preprinted medication order forms that would ensure safe and effective use of
medications;
4. Failure to develop and implement written policies and procedures to ensure the
safe and effective use of medications with black box warnings, such that staff was
unaware of the warnings and patients using the medications were not monitored
appropriately;
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5. Failure to ensure that medications dispensed for patient care were administered as
ordered and in accordance with facility-approved protocols, such that the hospital
failed to clarify an incomplete medication order and failed to follow facility-approved
policies and procedure for safe administration of a medication;
6. Failure to have written policies and procedures for the establishment of a safe
and effective system for the distribution, dispensing, and use for patient care of
biologicals;
7. Failure to ensure that staff could accurately and quickly calculate a dose for
emergency medications for pediatric use;
8. Failure to provide patient safety by ensuring that written policies and procedures
for the distribution of all drugs were developed and implemented to ensure the safe
use of medications;
9. Failure to ensure specialty consultation by a physician, ongoing medical evaluation,
medically-stabilizing treatment and physician intervention to ensure prompt transfer
to a higher level of care for a patient who presented to the Emergency Department;
10. Failure to ensure prompt nursing assessments and medical care for a patient who
presented to the emergency department, where the hospital failed to ensure the
availability of competent and appropriate nurse staffing resources so that patients
could receive prompt treatment;
11. Failure to ensure that registered nurses were appropriately trained, such that the
inconsistency in the nurses’ knowledge regarding the administration of intravenous
medication boluses led to a lack of uniformity in the responses regarding the
administration of potentially dangerous intravenous medication boluses in the
intensive care unit setting;
12. Failure to develop and implement policies and procedures in the operating room to
eliminate retained foreign objects after surgery; and
13. Failure to provide adequate on-call physician coverage to meet the needs of
patients receiving emergency care in the emergency department and failure to
maintain an effective call system to provide care to patients in the intensive care
unit.
CDPH statistics show that many of the administrative penalties assessed in the past few
years were related to medication or pharmacy errors, or to foreign objects retained after
surgery, though the list of what circumstances can give rise to an administrative penalty
expands from year to year. CDPH has posted information about the administrative penalties
it has assessed, along with each hospital’s State-2567, by year and by hospital, at https://
www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/Hospital-Administrative-Penalties-by-Year.
aspx.
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CHA Catalog of Administrative Penalties
The California Hospital Association (CHA) has developed an administrative penalty catalog
to track citations and fines resulting from IJs. For each event, the catalog provides key
details about the event, including the CDPH district office that investigated the event, the
number of days between the beginning of the investigation and the date the penalty was
issued, the amount of the penalty, and a description of the event and plan of correction,
if that information is available. The catalog uses publicly available information from CDPH
press releases, the Health Facilities Consumer Information System website and State-2567
forms gathered from the CDPH website. Although information on these penalties is publicly
available, it is difficult to find and compile, and difficult to use the data to identify trends and
improve activities. The catalog makes this easier. Users should realize there are flaws and
inaccuracies in CDPH’s publicly available source material that is reflected in the catalog.
When reviewing the immediate jeopardy information in the catalog, hospitals are encouraged
to review each State-2567 form in its entirety to fully understand the circumstances of
the administrative penalty/immediate jeopardy and the plan of correction implemented to
eliminate the immediate jeopardy. Please note that each plan of correction relates only to that
specific deficiency; however, this can be helpful in understanding options when developing
systems to prevent this type of error in the future.
The catalog is available (to CHA members only) at www.calhospital.org/ij-catalog/reports.
B. Administrative Penalties: Calculating the Amount
Background and Application
CDPH may issue administrative penalties against hospitals for violations of licensing
requirements that have been cited by surveyors on a State-2567. [Title 22, California Code of
Regulations, Sections 70951 and 71702]
The regulations described in this part of the manual describe how CDPH will determine the
amount of the penalty. However, these regulations do not apply to settlement of enforcement
actions or in the following situations:
1. Penalties imposed for discrimination or retaliation against a whistleblower pursuant
to Health and Safety Code Section 1278.5.
2. Penalties imposed for privacy breaches (see E.“Administrative Penalties: Privacy
Breaches,” page2.24).
3. Penalties imposed for failure to report, or late reporting of, an adverse event (see
Appendix HS-2, “Adverse Event Reporting Requirement.”) These penalties are
different from the penalties for the adverse event itself, which are subject to these
regulations.
4. Penalties imposed for violation of state “anti-dumping” laws (see C.“Civil Penalties:
Violation of State “Anti-Dumping” Laws,” page2.23).
CHA has created an abbreviated instruction sheet for calculating an administrative penalty;
see Appendix HS-14, “Instructions for Calculating an Administrative Penalty.” This portion of
the manual explains the steps in detail.
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Definitions
“Actual financial harm” means concrete financial loss for medical costs incurred by a
patient, where the loss was not covered or reimbursed by health insurance.
“Deficiency” means a licensee’s failure to comply with any law relating to the operation or
maintenance of a hospital as a requirement of licensure under the Health and Safety Code or
Division 5 of Title 22 of the California Code of Regulations.
“Hospital licensing requirements,” “hospital licensing standards” and “licensure
requirements” refer to the requirements in Health and Safety Code, Division 2, Chapter 2
and Division 107, Part 2, Chapter 2.5, Article 1 applicable to hospitals, and the regulations
adopted thereunder. The former reference is to the hospital licensing provisions of the Health
and Safety Code (Sections 1250-1339.59), while the latter reference is to the Hospital Fair
Pricing Policies law (Health and Safety Code Sections 127400-127462).
“Repeat deficiencies” means violations of hospital licensing requirements or federal
certification standards in the same or substantially similar regulatory grouping of
requirements, which are found during an inspection, subsequently corrected, and found
again at a subsequent inspection.
“Substantial compliance” means a level of compliance with state hospital licensing
standards and with federal laws that set forth the Conditions of Participation for hospitals in
the Medicare program, such that any identified deficiencies pose no greater risk to patient
health and safety than the potential for causing minimal harm.
“Willfulness,” “willfully” or “willful” means that the person doing an act or omitting to do an
act intends the act or omission, and knows the relevant circumstances connected with the
act or omission.
“Willful violation” means that the licensee (hospital), through its employees or contractors,
willfully commits an act or makes an omission with knowledge of the facts, which bring the
act or omission within the deficiency that is the basis for an administrative penalty.
[Title 22, California Code of Regulations, Section 70952]
Calculating the Penalty: Deficiencies Unrelated to the Hospital Fair Pricing Policies
Law
This part of the manual describes how CDPH will calculate a penalty for a deficiency
unrelated to the Hospital Fair Pricing Policies law (also called the “charity care” law).
This includes most deficiencies listed on the State-2567. (See “Calculating the Penalty:
Deficiencies Related to the Hospital Fair Pricing Policies Law,”page2.20, for information
about calculating the penalty for a deficiency related to the Hospital Fair Pricing Policies law.)
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Scope and Severity Matrix
CDPH has developed a matrix to help its surveyors determine the amount of an
administrative penalty for a particular deficiency. The starting amount of a penalty is based on
the scope and severity of the deficiency. See the third page of Appendix HS-14, “Instructions
for Calculating an Administrative Penalty,” for the initial penalty amount in dollars.
CDPH starts by determining an initial penalty based on the matrix, and then adjusting it to
produce an amount known as the “base penalty” (sometimes called the “adjusted initial
penalty”). CDPH will then adjust the base penalty. The result of this second calculation is
called the “adjusted base penalty” or the “final penalty.” The base penalty or adjusted initial
penalty may exceed the statutory maximum, but the final penalty may not. The statutory
maximum penalty is the amount of an immediate jeopardy penalty. [Title 22, California Code
of Regulations, Sections 70953, 70956 and 70958] Each of these steps is explained more
thoroughly below.
Initial Penalty
First Adjustment
Base Penalty
Second Adjustment
Final Penalty
(Maximum = Amount of IJ Penalty)
Determining an Initial Penalty
CDPH determines the initial penalty for each deficiency by considering the severity and scope
of the deficiency, using the matrix above [Title 22, California Code of Regulations, Section
70954].
Severity
The severity levels are designed to consider the actual and potential harm to patients that
the deficiency caused or could have caused. CDPH will consider the patient’s physical and
mental condition, and the probability and severity of the risk that the violation presents to
patients. The severity levels range from Severity Level 1 (no actual harm; potential for no
more than minimal harm) to Severity Level 6 (immediate jeopardy to patient health or safety
that caused the death of a patient).
Scope
CDPH will also determine the scope of the noncompliance with hospital licensure
requirements using the matrix above. CDPH will label the scope as isolated, pattern or
widespread, as follows:
Isolated:
1. One or a very limited number of patients affected, or
2. One or a very limited number of staff involved, or
3. The situation occurred only occasionally, or
4. The situation occurred in a very limited number of locations.
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Pattern:
1. More than a very limited number of patients affected, or
2. More than a very limited number of staff involved, or
3. The situation occurred in several locations, or
4. The same patients had been affected by repeat occurrences.
Widespread:
1. The situation was pervasive throughout the hospital, or
2. The situation represented a systemic failure that affected or had the potential to
affect a large portion or all of the hospital’s patients.
To calculate the initial penalty, CDPH will find the percent figure in the cell that corresponds
to the severity and the scope of the deficiency, and then apply that percentage to the dollar
amount that applies, based on the severity and, if the deficiency is considered an IJ, the
hospital’s own history of receiving IJ penalties, as follows:
Severity Levels 6, 5 and 4 constitute immediate jeopardies. The initial penalties for
these levels are the appropriate percentage of $75,000 if this is the hospital’s first IJ penalty,
$100,000 if this is the hospital’s second IJ penalty, and $125,000 if this is a third or subsequent
IJ penalty. An IJ penalty is considered a first penalty if the date the violation occurred is more
than three years from the date of the violation of the last issued IJ penalty, and CDPH finds that
the hospital has been in substantial compliance for three years prior to the date of the violation.
Severity Levels 3 and 2 do not constitute immediate jeopardies. The initial penalty is the
appropriate percentage of $25,000.
Severity Level 1 and minor violations do not result in a financial penalty. A minor violation
means any violation of law relating to the operation or maintenance of a hospital that CDPH
determines has only a minimal relationship to the health or safety of hospital patients. However,
a violation of the Hospital Fair Pricing Policies law may result in a penalty even if it could be con-
sidered “minor” under this definition (see “Calculating the Penalty: Deficiencies Related to the
Hospital Fair Pricing Policies Law,”page2.20). [Title 22, California Code of Regulations, Sec-
tions 70951(a)(1) and 70952(a)(4)]
EXAMPLE 1. A hospital has a deficiency that CDPH considers to be a Severity Level
5 and of widespread scope. The hospital has never had an IJ penalty before. The
initial penalty will be 80% of $75,000, which equals $60,000.
EXAMPLE 2. A hospital has a deficiency that CDPH considers to be a Severity Level
2 and of isolated scope. The initial penalty will be 20% of $25,000, which equals
$5,000.
Adjusting the Initial Penalty
The initial penalty may be increased or decreased to calculate the “base penalty” (sometimes
called the “adjusted initial penalty”), according to the following guidelines. [Title 22, California
Code of Regulations, Section 70955]
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1. The patient’s physical and mental condition
The initial penalty will be increased by 10 percent if the violation caused actual harm
to the patient at Severity Level 3 or 5, resulting in a physical or mental impairment
that substantially limits one or more of the major life activities of a patient, or the
loss of bodily function, if the impairment or loss lasts more than seven days or is still
present at the time of discharge, or the loss of a body part; or
The initial penalty will be increased by 5 percent if the violation caused actual harm
to the patient at Severity Level 3 or 5 resulting in a physical or mental impairment
that substantially limits one or more of the major life activities of a patient, or the
loss of bodily function, if the impairment or loss lasts more than three days.
2. Financial harm to the patient
The initial penalty will be increased by 1 percent if the violation caused actual
financial harm to the patient, based on information acquired by CDPH during the
investigation.
3. Factors beyond the hospital’s control
The initial penalty will be decreased by 5 percent if there were factors beyond
the hospital’s control that restricted the hospital’s ability to comply with licensure
requirements, and if the hospital developed and maintained disaster and emergency
programs as required by state and federal law that were appropriately implemented
during a disaster.
4. Willful violation
The initial penalty will be increased by 10 percent if the deficiency was the result of
a willful violation.
Adjusting the Base Penalty
The “base penalty” (sometimes called the “adjusted initial penalty”) will be adjusted to
determine the final penalty. This adjustment is based upon whether the hospital immediately
corrects the violation and the hospital’s history of compliance with state hospital licensure
laws and the federal Conditions of Participation [Title 22, California Code of Regulations,
Section 70957].
1. Immediate correction of the violation
When CDPH determines that a hospital subject to an administrative penalty
promptly corrects the noncompliance, the base penalty will be reduced by 20
percent, if all of the following apply:
a. The hospital identified and immediately corrected the noncompliance before it
was identified by CDPH. Within 10 calendar days of the date that the hospital
identified the noncompliance, the hospital must complete corrective action
and take appropriate steps necessary to prevent the violation from recurring.
The hospital must promptly, and in detail, document the corrective action. The
appropriateness of the plan of correction must be approved by CDPH.
b. The noncompliance that was corrected did not constitute immediate jeopardy
or result in the death of a patient.
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c. The hospital complied with mandatory reporting requirements before the
noncompliance was identified by CDPH.
d. A penalty was not imposed for a repeat deficiency that received a penalty
reduction under these regulations with the 12-month period prior to the date
of the violation.
2. History of compliance with state and federal laws
A hospital’s compliance history refers to its record of compliance with licensure
requirements under the Health and Safety Code, and the regulations adopted
thereunder, and with the Conditions of Participation for hospitals in the Medicare
program, for a period of three years prior to the date the administrative penalty is
issued.
The base penalty will be reduced by 5 percent if hospital inspections within the last
three years noted no state or federal deficiencies that resulted in patient harm or
immediate jeopardy (Severity Levels 3 through 6).
The base penalty will be increased by 5 percent if the hospital has three or more
repeat deficiencies that pose a risk of more than minimal harm to patient health or
safety (Severity Levels 2 through 6) within the three year period immediately prior to
the date of the violation.
Determining the Final Penalty
The calculations above will result in the final penalty. However, the final penalty may not
exceed the maximum penalty specified in Health and Safety Code Section 1280.3, which
is $25,000 for a violation that does not constitute an IJ, $75,000 for the hospital’s first
IJ penalty, $100,000 for the hospital’s second IJ penalty, and $125,000 for the third or
subsequent IJ penalty. An IJ penalty is considered a first penalty if the date the violation
occurred is more than three years from the date of the violation of the last issued IJ penalty,
and if CDPH finds that the hospital has been in substantial compliance for three years prior to
the date of the violation.
Calculating the Penalty: Deficiencies Related to the Hospital Fair Pricing Policies
Law
This part of the manual describes how CDPH will calculate a penalty for a deficiency
related to the Hospital Fair Pricing Policies law — also known as the “charity care” law.
(See “Calculating the Penalty: Deficiencies Unrelated to the Hospital Fair Pricing Policies
Law,”page2.16, for information about calculating the penalty for a deficiency unrelated to
the Hospital Fair Pricing Policies law.) For these deficiencies, CDPH will consider the extent
of noncompliance, the amount of financial harm to the patient, and the willfulness of the
violation. Acute psychiatric hospitals are not subject to the Hospital Fair Pricing Policies law,
and thus will not be penalized by CDPH under these regulations.
Just as with penalties for deficiencies unrelated to the Hospital Fair Pricing Policies law,
CDPH starts by determining an initial penalty and then adjusting it to produce an amount
known as the “base penalty” (sometimes called the “adjusted initial penalty”). CDPH will
then adjust the base penalty. The result of this second calculation is called the “adjusted
base penalty” or the “final penalty.” The base penalty or adjusted initial penalty may exceed
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the statutory maximum, but the final penalty may not. The statutory maximum penalty is the
amount of an immediate jeopardy penalty. [Title 22, California Code of Regulations, Sections
70953, 70956 and 70958] Each of these steps is explained more thoroughly below.
Initial Penalty
First Adjustment
Base Penalty
Second Adjustment
Final Penalty
(Maximum = Amount of IJ Penalty)
Calculating the Initial Penalty
CDPH determines the initial penalty for a violation of the Hospital Fair Pricing Policies law by
considering whether the noncompliance is major, moderate or minimal, as described below.
Major
The action or inaction deviates from the requirement to such an extent that the requirement
is completely ignored and none of its provisions is complied with, or the function of the
requirement is rendered ineffective because some of its provisions are not complied with. The
initial penalty for this category is $25,000.
Moderate
The action or inaction deviates from the requirement, but it complies to some extent,
although not all of its important provisions are complied with. The initial penalty for this
category is $12,500.
Minimal
The action or inaction deviates somewhat from the requirement. The requirement functions
nearly as intended, but not as well as if all provisions had been met. A violation in this
category is a minor violation and no administrative penalty is assessed.
Adjusting the Initial Penalty
The initial penalty will be adjusted to determine the “base penalty” (sometimes called the
“adjusted initial penalty”) based upon the financial harm to the patient and the willfulness of
the violation.
The initial penalty will be increased by 5 percent if the violation caused actual financial harm
to the patient, based on information acquired by CDPH during its investigation.
The initial penalty will be increased by 10 percent if the deficiency was the result of a willful
violation.
The base penalty may exceed the statutory maximum, although the final penalty may not.
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Adjusting the Base Penalty
The “base penalty” (sometimes called the “adjusted initial penalty”) will be adjusted to
determine the final penalty. This adjustment is based upon whether the hospital immediately
corrects the violation and the hospital’s history of compliance with the Hospital Fair Pricing
Policies law. [Title 22, California Code of Regulations, Section 70959].
1. Immediate correction of the violation
When CDPH determines that a hospital subject to an administrative penalty
promptly corrects the noncompliance, the base penalty will be reduced by 20
percent, if both of the following apply:
a. The hospital identified and immediately corrected the noncompliance before it
was identified by CDPH. Within 10 calendar days of the date that the hospital
identified the noncompliance, the hospital must complete corrective action
and steps necessary to prevent the violation from recurring. The hospital must
promptly, and in detail, document the corrective action.
b. A penalty was not imposed for a repeat deficiency that received a penalty
reduction under these regulations with the 12-month period prior to the date
of the violation.
2. History of compliance
The base penalty will be increased by 10 percent if the hospital has had one or
more other violations of the Hospital Fair Pricing Policies law within the three-year
period immediately prior to the date of the violation.
Determining the Final Penalty
The calculations above will result in the final penalty. The final penalty may not exceed the
maximum penalty specified in Health and Safety Code Section 1280.3, which is $25,000 for
a violation that does not constitute an IJ, $75,000 for the hospital’s first IJ penalty, $100,000
for the hospital’s second IJ penalty, and $125,000 for the third and subsequent IJ penalty.
An IJ penalty is considered a first penalty if the date the violation occurred is more than three
years from the date of the violation of the last issued IJ penalty, and if CDPH finds that the
hospital has been in substantial compliance for three years prior to the date of the violation. It
is not clear whether a violation of the California Hospital Fair Pricing Policies law can ever be
considered to rise to the level of an immediate jeopardy — that is, serious injury or death to a
patient.
Other Factors Influencing the Penalty Amount
Hospitals Affiliated With Health Plans
In assessing an administrative penalty against a health facility owned by a nonprofit
corporation that shares an identical board of directors with a nonprofit health care service
plan licensed pursuant to the Knox-Keene Act, CDPH must consider whether the deficiency
arises from an incident that is the subject of investigation of, or has resulted in a fine to the
health care service plan by, the Department of Managed Health Care. If the deficiency results
from the same incident, CDPH may adjust its penalty to take into consideration the penalty
imposed by the Department of Managed Health Care. [Health and Safety Code Section
1280.6; Title 22, California Code of Regulations, Section 70958.1]
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Small and Rural Hospitals
A small and rural hospital that has been assessed an administrative penalty may request:
1. Payment of the penalty extended over a period of time, if full payment would cause
financial hardship, or
2. Reduction of the penalty, if extending the penalty payment over a period of time,
would cause financial hardship, or
3. Both a penalty payment plan and reduction of the penalty.
The small and rural hospital must submit its request in writing to CDPH within 10 days
after the issuance of the administrative penalty. The request must describe the special
circumstances showing financial hardship to the hospital and the potential severe adverse
effects on access to quality care in the hospital.
CDPH will base its decision on information provided by the small and rural hospital and on
hospital financial information from the Office of Statewide Health Planning and Development
or other governmental agency.
[Title 22, California Code of Regulations, Sections 70960 and 71703]
C. Civil Penalties: Violation of State “Anti-Dumping” Laws
CDPH may also assess a penalty against a hospital for a violation of state “anti-dumping”
laws for up to $25,000 per violation. In determining the amount of the fine, CDPH must take
into account all of the following:
1. Whether the violation was knowing or unintentional.
2. Whether the violation resulted or was reasonably likely to result in a medical hazard
to the patient.
3. The frequency or gravity of the violation.
4. Other civil fines that have been imposed by the federal government for violations
of EMTALA. The state may not impose a penalty that, when added to a penalty
imposed under federal law, exceeds $30,000.
However, this penalty provision does not apply to an alleged violation by a hospital owned
and operated by a health care service plan. Instead, the Department of Managed Health Care
has the oversight authority for these violations of the state anti-dumping laws.
Physicians are subject to a civil penalty for violation of state anti-dumping laws by the Medical
Board of California of up to $5,000 per violation. [Health and Safety Code Sections 1317-
1317.9]
(See CHA’s EMTALA: A Guide to Patient Anti-Dumping Laws, available at
www.calhospital.org/emtala-manual, for more information about federal and California anti-
dumping laws.)
D. Administrative Penalties: Violations of Nurse-to-Patient Staffing Ratios
If CDPH determines that a hospital violated the nurse-to-patient ratio regulation, it must issue
an administrative penalty of $15,000 for the first violation and $30,000 for the second or
subsequent violation. However, a general acute care hospital is not subject to a penalty if the
hospital demonstrates to CDPH’s satisfaction all of the following:
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1. That any fluctuation in required staffing levels was unpredictable and uncontrollable.
2. Prompt efforts were made to maintain required staffing levels.
3. In making those efforts, the hospital immediately used and subsequently exhausted
the hospital’s on-call list of nurses and the charge nurse.
Hospitals must document their efforts to maintain required staffing levels. [Health and Safety
Code Section 1280.3]
CDPH has adopted the following definitions:
1. “Unpredictable” means unable to be known in advance.
2. “Uncontrollable” means outside the facilitly’s control.
3. “Unpredictable and uncontrollable” means the facility had no way to know or
control the staffing shortage that occurred.
[All Facilities Letter 20-04, Jan. 16, 2020]
Multiple violations found during the same survey count as a single violation for purposes of
determining whether the violation was a first, second, or subsequent violation. A violation
occurring more than three years after the date of the last violation is treated as a first
violation.
CDPH may issue an administrative penalty for a staffing violation under this provision of law
as well as an administrative penalty for any resulting harm pursuant to Health and Safety
Code Section 1280.3(a), which describes penalties for immediate jeopardy violations.
E. Administrative Penalties: Privacy Breaches
CDPH has the authority to issue administrative penalties for privacy breaches — that is, the
inappropriate access, review or viewing of patient medical information without a direct need
for medical diagnosis, treatment or other lawful use as permitted by the Confidentiality of
Medical Information Act or any other statute or regulation governing the lawful access, use or
disclosure of medical information [Health and Safety Code Section 1280.15].
CDPH may assess the following penalties for a hospital’s failure to prevent unlawful or
unauthorized access, use or disclosure of medical information:
1. Up to $25,000 per patient, and
2. Up to $17,500 per subsequent violation of that patient’s medical information.
In addition, the hospital may also be fined up to $100 per day for failure to timely self-report
a privacy breach to CDPH. However, the total combined penalties (for failure to prevent
unlawful or unauthorized access, use or disclosure and for the failure to make the required
self-reports) may not exceed $250,000 “per reported event.” The term “reported event”
means all breaches included in any single report that is made to CDPH, regardless of the
number of breach events contained in the report.
In assessing the penalties, the law requires CDPH to consider:
1. The history of the facility’s compliance with state and federal privacy and security
laws;
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2. The extent to which the facility detected violations and took preventative action to
immediately correct and prevent past violations from recurring; and
3. Factors outside the facility’s control that restricted the facility’s ability to comply.
CDPH is required to consider the special circumstances of small and rural hospitals (as
defined in Health and Safety Code Section 124840), and primary care clinics (as defined in
Health and Safety Code Section 1204), in order to protect access to quality care in those
hospitals and clinics.
Hospitals may appeal penalty assessments imposed by CDPH for privacy breaches following
the same process as that for appealing IJ penalties (see G.“Appealing a State Administrative
Penalty,” page2.25). In lieu of disputing a penalty, a hospital may pay only 75 percent of the
penalty provided they pay within 30 days of receipt of the penalty assessment.
A complete discussion of health information privacy law is beyond the scope of this manual.
CHA has published the California Health Information Privacy Manual to help hospitals
comply with the multitude of state and federal privacy laws. For more information, visit www.
calhospital.org/privacy.
F. Public Notice of Administrative Penalties
CDPH periodically issues a press release regarding the administrative penalties it has levied.
CDPH typically notifies each affected hospital’s CEO a day or so before the press release is
issued. The press release and each hospital’s State-2567 will be put on the CDPH website at
https://www.cdph.ca.gov/Programs/OPA/Pages/Office-of-Public-Affairs.aspx. The hospital
should develop a communication plan to prepare hospital employees for media inquiries and
to respond to those inquiries. (See I.“Communicating Survey Results,” page5.1.)
G. Appealing a State Administrative Penalty
If a hospital wishes to appeal a state administrative penalty, the hospital must notify CDPH by
letter within 10 calendar days after being notified of the penalty – that is, within 10 calendar
days after the hospital mailroom signs the certified mail receipt. The hospital may dispute:
1. A determination by CDPH regarding an alleged deficiency or alleged failure to
correct a deficiency;
2. The reasonableness of the proposed deadline for correction; and
3. The reasonableness of the amount of the penalty.
There is no formal content requirement, but typically, the hospital will send a fairly
comprehensive letter indicating why the immediate jeopardy deficiency should be withdrawn
and/or why no administrative penalty (or a lesser amount) should be assessed. Since this
letter serves as the basis to evaluate the legal standard and basis of an appeal, hospitals may
wish to work with legal counsel in drafting this letter.
Hospitals have experienced a long lag time between sending the letter requesting the appeal
and hearing from CDPH. During this lag time, the hospital does not need to pay the penalty;
penalties are paid only after the appeal, if the appeal is unsuccessful.
After it has received the hospital’s notice of appeal, the CDPH Office of Legal Services
(OLS) Administrative Litigation Unit will draft an accusation as required by the Administrative
Procedure Act and send it to the facility with an explanation of the next steps. The facility may
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file a notice of defense and submit it to OLS. OLS will then arrange a hearing. Alternatively,
CDPH will contact the hospital to determine whether the hospital wishes to continue the
appeal process. This may be considered an opportunity to negotiate. Some hospitals have
had their deficiency withdrawn, some have successfully challenged the imposition of a
penalty (and thus did not have to pay any penalty) and some hospitals have settled with
CDPH and paid a lower penalty than had originally been assessed by CDPH.
If a hearing is held, it will be conducted pursuant to the Government Code provisions that
govern formal administrative hearings [Government Code Section 11500 et seq.]. Penalties
need not be paid until all appeals have been exhausted and CDPH’s position has been
upheld. [Health and Safety Code Section 1280.1(b)]
3 Federal Surveys
Chapter 3 — Contents
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I. CMS Organizational Structure and Staffing ..................................................... 3.1
II. Types of Federal Surveys ................................................................................... 3.2
A. Certification/Recertification Survey ........................................................... 3.2
B. Complaint/Allegation Survey ...................................................................... 3.2
C. Validation Survey ......................................................................................... 3.3
III. Which Laws are Federal Surveyors Assessing Compliance With? ................ 3.3
A. Medicare Conditions of Participation .......................................................... 3.3
Acute Care Hospitals ...................................................................................... 3.4
Psychiatric Hospitals ....................................................................................... 3.5
Critical Access Hospitals (CAHs) ..................................................................... 3.5
Other Facilities/Services .................................................................................. 3.5
Condition vs. Standards .................................................................................. 3.6
Interpretive Guidelines and Survey Procedures................................................ 3.7
B. State Operations Manual ............................................................................. 3.7
Chapters ......................................................................................................... 3.8
Exhibits ........................................................................................................... 3.8
Appendixes .................................................................................................... 3.8
CMS Memos to Surveyors ............................................................................ 3.10
C. EMTALA ...................................................................................................... 3.10
D. Life Safety Code ......................................................................................... 3.11
Waivers ......................................................................................................... 3.11
Resources .................................................................................................... 3.12
IV. Federal Survey Process ................................................................................... 3.13
A. Overview ..................................................................................................... 3.13
B. Entrance Conference ................................................................................. 3.13
What to Provide the Survey Team ................................................................. 3.14
C. Surveyors’ Procedures .............................................................................. 3.16
Sample Size and Selection............................................................................ 3.16
Comprehensive Review ................................................................................ 3.17
Information Gathering by Surveyors: Observation/Interviews/Record
Review .......................................................................................................... 3.17
Patient Privacy Rights ................................................................................... 3.22
Daily Meetings .............................................................................................. 3.23
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D. Decision Making by Survey Team ............................................................. 3.23
Condition-Level vs. Standard-Level Deficiency .............................................. 3.23
Deficiency Determined to Have Occurred Prior to Survey .............................. 3.24
E. Exit Conference .......................................................................................... 3.24
Complaint Survey Exit Conference ................................................................ 3.25
Discontinuation of Exit Conference ................................................................ 3.25
V. Federal Survey Outcome .................................................................................. 3.26
A. No Deficiencies .......................................................................................... 3.26
B. Standard-Level Deficiency ........................................................................ 3.26
C. Condition-Level Deficiency ....................................................................... 3.26
D. Financial Penalties ..................................................................................... 3.27
Value-Based Purchasing ............................................................................... 3.27
E. Immediate Jeopardy (Federal) ................................................................... 3.27
Hospital Corrects IJ While Surveyors are On-Site .......................................... 3.29
Hospital Corrects IJ While Surveyors are On-Site, But Deficiencies
Remain: 90-Day Termination Track ................................................................ 3.29
Hospital Does Not Correct IJ While Surveyors are On-Site: 23-Day
Termination Track .......................................................................................... 3.29
VI. The Form CMS-2567: Statement of Deficiencies and Plan of Correction ... 3.30
A. Statement of Deficiencies .......................................................................... 3.30
B. Cover Letter From CMS Accompanying CMS-2567 ................................. 3.31
C. Plan of Correction ...................................................................................... 3.32
D. Public Availability of CMS-2567 ................................................................ 3.32
VII. CDPH/CMS Actions after PoC Submitted ...................................................... 3.33
A. Credible Allegation of Compliance ............................................................ 3.33
B. State Monitoring ......................................................................................... 3.33
C. Resurvey .................................................................................................... 3.34
VIII. The Termination Process ................................................................................. 3.34
A. Notice of Termination ................................................................................ 3.35
B. Hospital’s Response .................................................................................. 3.36
C. Public Notice .............................................................................................. 3.36
IX. Appealing a Final Determination to Terminate Medicare/Medicaid
Certification ....................................................................................................... 3.37
A. Effect of an Early Appeal ........................................................................... 3.38
B. Filing a Lawsuit .......................................................................................... 3.38
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This chapter focuses on federal surveys — surveys conducted according to federal rules and
assessing the hospital’s compliance with federal laws. This chapter describes the Centers
for Medicare & Medicaid Services (CMS) organizational structure and staffing, types of
federal surveys, pertinent federal laws, detailed information about the surveyors’ procedures,
the Statement of Deficiencies and Plan of Correction, and termination from the Medicare
program. (See chapter 2 regarding CDPH surveyors conducting state surveys.)
I. CMS ORGANIZATIONAL STRUCTURE AND STAFFING
The CMS headquarters (often referred to as the “Central Office”) are located in Baltimore,
Maryland. CMS has ten regional offices (ROs) throughout the country. California is located in
Region 9, and the RO is located in San Francisco.
The Deputy Regional Administrator for Region 9 is currently Catherine (Cate) Kortzeborn.
The Associate Regional Administrator of the Division of Survey and Certification — the
unit in charge of certifying Medicare providers — is Steve Chickering. Julius Bunch is the
Certification and Enforcement Branch Manager for the Western Division of Survey and
Certification; he is located in the CMS Seattle office. Judith Somerby is the point person for
psychiatric hospitals. Contact information for all CMS employees may be found at https://
directory.psc.gov/employee.htm.
CMS has a website that contains a wealth of information at www.cms.gov. Click on “About
CMS” at the very top of the web page to learn more about CMS leadership, regional
office structure, and more. Information about the Western Division of the Survey and
Certification may be found at https://www.cms.gov/medicare/provider-enrollment-and-
certification/surveycertificationgeninfo/downloads/regional_and_central_office_contacts.pdf.
As mentioned in B.“Federal Certification,” page1.2, CMS has contracted with CDPH to
assist in assessing California hospitals’ compliance with the federal Medicare and Medicaid
requirements (the Conditions of Participation (CoPs)). CDPH surveyors, therefore, perform
hospital surveys on behalf of CMS. (See B.“CDPH Staffing/Surveyors,” page2.1, for more
information about CDPH surveyors and the survey team.) CMS also directly employs some
surveyors itself. The CMS-employed surveyors perform surveys on a random sample basis. In
addition, they may accompany CDPH surveyors where there are special circumstances, such
as a very serious issue at a hospital, a dispute between a hospital and CDPH, or a potential
difference of opinion between CDPH and CMS.
CMS provides on-training for surveyors around the country, available at https://qsep.cms.
gov/welcome.aspx. Hospital staff may also access this free training.
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II. TYPES OF FEDERAL SURVEYS
As described above, CMS contracts with CDPH to assess compliance with Medicare
requirements. There are three types of surveys:
1. Certification/recertification survey
2. Complaint/allegation survey
3. Validation survey
These are described below. Surveys generally follow the same overall process, though there
are some differences depending on the type of survey and its objective.
Surveyors may refer to any of the three types of surveys listed above as a “validation
survey.” This may be confusing to hospitals.
The size and composition of the survey team depends upon the type of survey to be
conducted, the size of the facility, the complexity of services offered, whether the facility has
a historical pattern of serious deficiencies or complaints, and whether new surveyors are
accompanying the team as part of their training. A survey may last for just a few hours or may
last for several days, depending upon the reason for the survey. CMS states that a suggested
survey team for a full certification or recertification survey of a mid-size hospital would include
two to four surveyors who will be at the facility for three or more days.
A. Certification/Recertification Survey
A certification survey is a comprehensive survey to determine whether the hospital meets
all of the CoPs (see III.“Which Laws are Federal Surveyors Assessing Compliance With?,”
page3.3). Recertification occurs on a cyclical basis (approximately every 3 years) to
confirm that the hospital continues to meet the Medicare requirements.
As described in B.“Federal Certification,” page1.2, many hospitals are accredited by The
Joint Commission or other national accreditation organizations and therefore are “deemed”
to be compliant with Medicare requirements. So long as a hospital remains deemed in
compliance with Medicare requirements by an authorized accreditation organization, it is
subject to a validation survey rather than a certification or recertification survey.
B. Complaint/Allegation Survey
A complaint/allegation survey is conducted when CMS has received a complaint and
determined that it raises a “substantial allegation of noncompliance” that, if substantiated,
would affect the health and safety of patients and may constitute a condition-level deficiency
(see “Condition-Level vs. Standard-Level Deficiency,” page3.23). If a complaint alleges
condition-level noncompliance, CMS may refer it for investigation to either the State Survey
Agency (CDPH in California) or, if the hospital has deemed status, to the accrediting
organization. If a complaint does not allege condition-level noncompliance, CMS may do the
same, or may advise the complainant to file the complaint with the accrediting organization
or ask for the complainant’s permission to release the information to the accrediting
organization, if the hospital has deemed status. A hospital is not automatically informed if a
complaint is referred to the accreditation organization.
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Usually, CMS initially limits complaint/allegation surveys to only those CoPs related to the
complaint. However, CMS and the State Survey Agency have leeway to expand the scope of
the survey to other CoPs if the surveyors identify additional problems.
A complaint may be submitted by any patient, employee, visitor, other health care provider
or any other individual in person, by telephone, through written correspondence, or in a
newspaper or magazine article. The surveyors will follow the procedures set forth in chapter
5 of the State Operations Manual and described in this manual. (See B.“State Operations
Manual,” page3.7, for more information about the manual.) The prioritization, investigation
time frames, and referral possibilities related to various types of complaint surveys are shown
in CHA Appendix HS-6, “Maximum Time Frames Related to the Federal On-Site Investigation
of Complaints/Incidents.”
If during a complaint/allegation survey, the State Survey Agency substantiates a deficiency
(either related or unrelated to the complaint) and CMS determines the hospital is out of
compliance with any CoP, CMS may authorize a “full review” (also called a “full survey”)
— that is, a survey for compliance with all of the CoPs. The CMS regional office will
determine whether a full survey is appropriate after considering the manner and degree
of noncompliance, the hospital’s compliance history, recent changes in the provider’s
ownership or management, whether the resources to conduct a full survey are available in
the time frame needed, and the length of time since the hospitals’ last accreditation survey.
Alternatively, if CMS determines that the hospital is out of compliance with a CoP, CMS may
skip the “full review” and place the hospital on a termination track (see VIII.“The Termination
Process,” page3.34).
C. Validation Survey
Validation surveys are conducted on a random sample basis to validate the accreditation
process and the accreditation organization’s performance. In other words, a hospital that
is accredited by The Joint Commission or other accreditation organization with deeming
authority, and therefore is deemed to be compliant with the CoPs, may be subject to a
validation survey to confirm that the accreditation organization did its job properly, and that
the hospital in fact meets the CoPs. Validation surveys may be comprehensive or focused on
a specific condition or standard. If an accredited hospital is found during a validation survey
to have significant deficiencies, it will no longer be deemed to meet the CoPs and CMS will
authorize a “full review” or “full survey” (that is, a survey for compliance with all of the CoPs).
A validation survey may also occur if CMS believes it has received a substantial allegation of
noncompliance. This may arise in the context of a state survey or from a complaint.
III. WHICH LAWS ARE FEDERAL SURVEYORS ASSESSING COMPLIANCE
WITH?
A. Medicare Conditions of Participation
Surveyors who are conducting a federal survey will assess the hospital’s compliance with
the federal regulations called the Medicare “Conditions of Participation” (CoPs). The CoPs
are found in Title 42 of the Code of Federal Regulations, part 482 (for CAHs, they are
found in part 485). (See “Where to Find Laws Referenced in the Manual” at the beginning
of the manual, to learn where the exact text of the CoPs may be found on the Internet.)
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The requirements in the CoPs apply to all patients in a Medicare- or Medicaid-participating
hospital, not just to Medicare or Medicaid patients.
Acute Care Hospitals
There are 24 CoPs for acute care hospitals (not critical access hospitals). They are:
Administration
482.11. Condition: Compliance with federal, state and local laws
482.12. Condition: Governing body
482.13. Condition: Patient’s rights
482.15. Condition: Emergency preparedness
Basic Hospital Functions
482.21. Condition: Quality assessment and performance improvement program
482.22. Condition: Medical staff
482.23. Condition: Nursing services
482.24. Condition: Medical record services
482.25. Condition: Pharmaceutical services
482.26. Condition: Radiologic services
482.27. Condition: Laboratory services
482.28. Condition: Food and dietetic services
482.30. Condition: Utilization review
482.41. Condition: Physical environment
482.42. Condition: Infection prevention and control and antibiotic stewardship programs
482.43. Condition: Discharge planning
482.45. Condition: Organ, tissue, and eye procurement
Optional Hospital Services
482.51. Condition: Surgical services
482.52. Condition: Anesthesia services
482.53. Condition: Nuclear medicine services
482.54. Condition: Outpatient services
482.55. Condition: Emergency services
482.56. Condition: Rehabilitation services
482.57. Condition: Respiratory care services
482.58. Condition: Special requirements for hospital providers of long-term care services
(“swing-beds”)
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Psychiatric Hospitals
There are two additional CoPs for acute psychiatric hospitals:
482.61. Condition: Special medical record requirements for psychiatric hospitals
482.62. Condition: Special staff requirements for psychiatric hospitals
Critical Access Hospitals (CAHs)
There are different conditions for critical access hospitals. They are:
485.608. Condition: Compliance with federal, state and local laws and regulations
485.610. Condition: Status and location
485.612. Condition: Compliance with hospital requirements at time of application
485.616. Condition: Agreements
485.618. Condition: Emergency services
485.620. Condition: Number of beds and length of stay
485.623. Condition: Physical plant and environment
485.625. Condition: Emergency preparedness
485.627. Condition: Organizational structure
485.631. Condition: Staffing and staff responsibilities
485.635. Condition: Provision of services
485.638. Condition: Clinical records
485.639. Condition: Surgical services
485.640. Condition: Infection prevention and control and antibiotic stewardship programs
485.641. Condition: Quality assessment and performance improvement program
485.642. Condition: Discharge planning
485.643. Condition: Organ, tissue, and eye procurement
485.645. Special requirements for CAH providers of long-term care services
(“swing-beds”)
485.647. Condition: Psychiatric and rehabilitation distinct part units
Other Facilities/Services
There are additional or different CoPs for long-term care services (“swing-beds”), transplant
centers, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, and other
providers and services. Hospitals should check the State Operations Manual appendix
that applies to their facility to learn which CoPs apply (see B.“State Operations Manual,”
page3.7, for more information).
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Condition vs. Standards
The CoPs are, in many cases, somewhat imprecise. For example, Section 482.26, Radiologic
Services, states in its entirety:
Section 482.26 Condition: Radiologic services. The hospital must maintain, or
have available, diagnostic radiologic services. If therapeutic services are also provided,
they, as well as the diagnostic services, must meet professionally approved standards
for safety and personnel qualifications.
(a) Standard: Radiologic services. The hospital must maintain, or have available,
radiologic services according to needs of the patients.
(b) Standard: Safety for patients and personnel. The radiologic services,
particularly ionizing radiology procedures, must be free from hazards for patients
and personnel.
(1) Proper safety precautions must be maintained against radiation hazards.
This includes adequate shielding for patients, personnel, and facilities, as
well as appropriate storage, use, and disposal of radioactive materials.
(2) Periodic inspection of equipment must be made and hazards identified
must be promptly corrected.
(3) Radiation workers must be checked periodically, by the use of exposure
meters or badge tests, for amount of radiation exposure.
(4) Radiologic services must be provided only on the order of practitioners
with clinical privileges or, consistent with State law, of other practitioners
authorized by the medical staff and the governing body to order the
services.
(c) Standard: Personnel.
(1) A qualified full-time, part-time, or consulting radiologist must supervise the
ionizing radiology services and must interpret only those radiologic tests
that are determined by the medical staff to require a radiologist’s specialized
knowledge. For purposes of this section, a radiologist is a doctor of
medicine or osteopathy who is qualified by education and experience in
radiology.
(2) Only personnel designated as qualified by the medical staff may use the
radiologic equipment and administer procedures.
(d) Standard: Records. Records of radiologic services must be maintained.
(1) The radiologist or other practitioner who performs radiology services must
sign reports of his or her interpretations.
(2) The hospital must maintain the following for at least 5 years:
(i) Copies of reports and printouts.
(ii) Films, scans, and other image records, as appropriate.
Each CoP contains one or more component “standards.” Notice that the Radiologic Services
CoP printed above contains four standards (in bold type above and repeated below):
1. 482.26(a) Standard: Radiologic Services
2. 482.26(b) Standard: Safety for patients and personnel
3. 482.26(c) Standard: Personnel
4. 482.26(d) Standard: Records
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If a hospital is found to be out of compliance with a CoP (called a “condition-level
deficiency”), CMS will put the hospital on a termination track. However, if the hospital is
not out of compliance with the entire CoP, but only out of compliance with one or more
standards (called a “standard-level deficiency”), the hospital will be required to complete
a plan of correction and undergo State Survey Agency monitoring, but will not be put on
a termination path. (See “Condition-Level vs. Standard-Level Deficiency,” page3.23,
B.“State Monitoring,” page3.33, and VIII.“The Termination Process,” page3.34, regarding
termination tracks.)
If a hospital is found to be out of compliance with two CoPs, the surveyors will carefully
assess compliance with the Governing Body CoP, also, and may very well find the hospital
out of compliance with that CoP as well.
Interpretive Guidelines and Survey Procedures
CMS has published additional guidance, called “Interpretive Guidelines,” to clarify surveyors’
(and hospitals’) understanding of the CoPs and to keep surveyors throughout the country
consistent. The Interpretive Guidelines also include “Survey Procedures,” directions for
surveyors to follow when assessing compliance with the CoPs. The Interpretive Guidelines
(and the survey procedures) are found in the appendixes to the State Operations Manual,
discussed below.
B. State Operations Manual
CMS has prepared a manual for State Survey Agency surveyors so that they understand
the survey process as well as how to interpret the CoPs. This manual is called the “State
Operations Manual” (SOM). It is published only on the Internet, thus CMS calls it an
“Internet-Only Manual” (IOM). It is found at www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo as Publication 100-07. It is searchable and printable.
Many portions are hundreds of pages long; be sure to check before you print.
CMS occasionally revises or updates the SOM. CMS announces the revisions or updates by
issuing to State Survey Agencies a separate memo (previously called “Survey & Certification
Memos”), rather than by revising the main online document. These memos are directed
to “State Survey Agency Directors” and have a code in the upper right-hand corner (for
example, Ref: QSO-19-09). At a later date, CMS updates the online document in accordance
with the memo — this may take months. Therefore, hospitals should not rely on the online
manual only. Instead, hospitals should also check for any relevant memos that were issued
since the last revision date of the relevant part of the online SOM (chapter or appendix) tht
the hospital is interested in. The first page of each online document comprising the SOM tells
its last revision date. (See “CMS Memos to Surveyors,” page3.10, for more information.)
The SOM provides guidance to surveyors and sets out CMS policy regarding survey
procedures as well as the specific requirements hospitals must meet. State Survey Agencies
are expected to refer to and comply with the SOM. The SOM is therefore an important
resource for hospitals, even though it is written for surveyors.
The SOM has eight chapters, hundreds of exhibits, and 24 appendixes. The most important
portions of the SOM with regard to hospital surveys are chapters 2, 3 and 5, as well as the
appendixes.
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Chapters
1. Chapter 1: Program Background and Responsibilities
2. Chapter 2: The Certification Process
3. Chapter 3: Additional Program Activities
(This chapter discusses sanctions for noncompliance with the CoPs, including the
process for terminating a hospital’s participation in the Medicare and Medicaid
programs.)
4. Chapter 4: Program Administration and Fiscal Management
5. Chapter 5: Complaint Procedures
6. Chapter 6: Special Procedures for Laboratories
7. Chapter 7: Survey and Enforcement Process for SNFs and NFs
8. Chapter 8: Standards and Certification
Exhibits
The exhibits are model letters and forms for the surveyors to use. Hospitals may wish to
review Exhibit 7A, Principles of Documentation. This exhibit is a tool to assist surveyors in
drafting the Form CMS-2567 “Statement of Deficiencies and Plan of Correction.” However, it
includes a disclaimer advising that it is “merely guidance” for surveyors and that it does not
impose obligations on either providers or surveyors.
Appendixes
The SOM contains numerous appendixes. Each appendix pertains to a particular type of
facility or service (except for Appendix Q which guides surveyors in determining when a
deficiency constitutes an immediate jeopardy under federal law). The appendixes are very
important, and are discussed in more detail below.
SOM Appendixes: Interpretive Guidelines
As mentioned above, each appendix to the SOM pertains to a particular type of facility or
service (except for Appendix Q, which guides surveyors in determining when a deficiency
constitutes an immediate jeopardy under federal law). Each appendix repeats the language
of the CoPs applicable to the relevant facility or service, and the standards that comprise
those CoPs. In addition, CMS has included additional guidance and a recommended survey
procedure for each CoP. Hospital managers need to be familiar with not only the CoPs and
the related standards, but also the Interpretive Guidelines. The Interpretive Guidelines provide
valuable insight into the agencies’ evaluation process and what the hospital must do to
comply with each CoP.
The appendixes that are most relevant for hospitals are:
1. A: Hospitals
2. B: Home Health Agencies
3. C: Laboratories and Laboratory Services
4. D: Portable X-Ray Service
5. E: Outpatient Physical Therapy or Speech Pathology Services
6. G: Rural Health Clinics
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7. H: End-Stage Renal Disease Facilities
8. I: Life Safety Code
9. K: Comprehensive Outpatient Rehabilitation Facilities
10. L: Ambulatory Surgical Services
11. M: Hospice
12. Q: Determining Immediate Jeopardy (applies to all facility types)
13. T: Swing-Beds
14. V: Responsibilities of Medicare Participating Hospitals in Emergency Cases
(EMTALA)
15. W: Critical Access Hospitals
16. X. Survey Protocol and Interpretive Guidelines for Organ Transplant Programs
17. Z: Emergency Preparedness for All Provider and Certified Supplier Types
NOTE: The SOM governs hospitals as well as numerous other types of health care facilities
and services such as hospices, home health agencies, nursing facilities, and intermediate
care facilities. In referring to the SOM, be sure to look at the appropriate facility or service
provisions.
Continuing with the Radiologic Services example, we see that Appendix A, Hospitals,
contains 25 pages of Interpretive Guidelines and survey procedures regarding the Radiologic
Services CoP. The Interpretive Guidelines provide background on definitions regarding
radiologic services, the necessary level of services to be provided and a general overview
of CMS’s expectations regarding the hospital’s radiologic services, including safety
requirements. The Interpretive Guidelines also provide information about nationally recognized
standards and recommendations regarding radiologic services. Finally, the survey procedures
outline the steps that the surveyors will undertake. For example, some of the procedures that
surveyors are directed to undertake with respect to assessing compliance with the Radiologic
Services CoP are:
1. Verify that radiological services are integrated into the hospital-wide QAPI program.
2. Observe locations where radiological services are provided. Are they safe for
patients and personnel? Are any hazards to patients or personnel observed?
3. Review the inspection records (logs) to verify that periodic inspections are
conducted in accordance with manufacturer’s instructions, federal and state laws,
regulations, and guidelines and hospital policy.
4. Verify that the hospital requires periodic checks on all radiology personnel and any
other hospital staff exposed to radiation and that the personnel are knowledgeable
about radiation exposure for month, year, and cumulative/entire working life.
5. Review medical records to determine that radiological services are provided only
on the orders of practitioners with clinical privileges and to practitioners outside the
hospital who have been authorized by the medical staff and the governing body to
order radiological services, consistent with state law.
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6. Determine which staff are using differing pieces of radiological equipment and/or
administering patient procedures. Review their personnel folders to determine they
meet the qualifications established by the medical staff for the tasks they perform.
The complete Interpretive Guidelines for the Radiologic Services CoP, including the survey
procedures, are found online (see B.“State Operations Manual,” page3.7).
Tags
The appendixes also contain “tags.” For Appendix A (Hospitals), the tags under the
Radiologic Services CoP are A-0528, A-0529, A-0535, A-0536, A-0537, A-0538, A-0539,
A-0546, A-0547, and A-0553. These tag numbers will be used by the surveyors in the Form
CMS-2567: “Statement of Deficiencies and Plan of Correction” to identify as specifically as
possible which requirement(s) the hospital failed to fulfill.
(The tags for Appendix W, Critical Access Hospitals, start with a “C” — for example, C-0168.
The tags for Appendix C, Laboratories, start with a “D” — for example, D5301. Tags for other
provider types or services may start with different letters.)
The tags do not precisely correspond to the conditions or the standards. A standard, for
example, may have one tag or may have several tags.
Hospitals should be familiar with the CoPs, their component standards, and the Interpretive
Guidelines. In preparing for surveys, hospitals should assign staff to “act like a surveyor” and
take each step noted in the survey procedures (see D.“Perform Mock Surveys,” page4.5).
As mentioned above, the CoPs, standards, Interpretive Guidelines, and survey procedures
are all found in the appendixes to the SOM.
CMS Memos to Surveyors
CMS frequently sends memos to State Survey Agency directors to clarify issues that may be
misunderstood by surveyors, to update surveyors on changes to the SOM, and to provide
survey tools to surveyors. These memos can be very helpful to hospitals in understanding
various aspects of the survey process as well as substantive areas of compliance. The
memos are referenced with a code and date (for example, QSO-19-09, dated Mar. 5, 2019)
and are posted on the CMS website at www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html.
Hospitals should check this website a couple of times per month to determine whether any
new items posted are relevant to their facility type or services provided.
C. EMTALA
Although the Emergency Medical Treatment and Labor Act (EMTALA) statute and regulations
are in a different part of the law from the CoPs, hospitals are required to comply with the
EMTALA requirements in order to participate in the Medicare and Medi-Cal programs.
The EMTALA statute is found at 42 U.S.C. Section 1395dd. The EMTALA regulations are
found at 42 C.F.R. Sections 489.20 and 489.24. (See “Where to Find Laws Referenced in the
Manual” at the beginning of the manual, for information about where the exact text of these
laws may be found on the Internet.) Appendix V to the SOM, “Responsibilities of Medicare
Participating Hospitals in Emergency Cases,” contains the Interpretive Guidelines and the
survey procedures related to EMTALA compliance (see “Appendixes,” page3.8).
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The enforcement of EMTALA is a complaint-driven process. The investigation of a hospital’s
policies and procedures and any subsequent sanctions are initiated by a complaint. The
survey process generally follows what is described in this manual for other complaint surveys
(that is, entrance conference, surveyor observations, exit conference, CMS-2567, plan of
correction, etc.). An EMTALA survey may also include a referral of medical records to the
CMS-contracted quality improvement organization (QIO; in California, this is Livanta) for
a physician to review to determine whether the medical screening exam was adequate,
stabilizing treatment was appropriate within the capability of the hospital, a transfer was
made with qualified personnel and transportation equipment, a transfer was appropriate, etc.
If the results of the complaint investigation indicate that a hospital violated one or more
EMTALA requirements, the hospital may be put on a termination track (see VIII.“The
Termination Process,” page3.34). In addition, civil monetary penalties of up to $111,597
per violation may be imposed against individual physicians and/or the hospital ($55,800 for
hospitals under 100 beds). (See D.“Financial Penalties,” page3.27.)
CHA publishes a manual dedicated to EMTALA compliance and enforcement titled, EMTALA:
A Guide to Patient “Anti-Dumping” Laws. Visit www.calhospital.org/emtala-manual for more
information about the manual or to order it.
D. Life Safety Code
The CoP for Physical Environment requires compliance with the Life Safety Code (LSC) and
Health Care Facilities Code (HCFC). The LSC is a set of fire protection requirements designed
to provide a reasonable degree of safety from fire. It covers construction, protection and
operational features designed to provide safety from fire, smoke and panic. The HCFC is a
set of requirements intended to provide minimum requirements for the installation, inspection,
testing, maintenance, performance and safe practices for facilities, material, equipment
and appliances.These documents are published and revised periodically by the National
Fire Prevention Association (NFPA). The basic requirement for facilities participating in the
Medicare and Medicaid programs is compliance with the 2012 edition of the LSC and HCFC.
In the past, CDPH contracted with the State Fire Marshal to provide the LSC surveyors.
However, CDPH now sends some of its HFENs to special life safety training given by CMS in
Baltimore, and those HFENs assess the hospital’s compliance with the LSC. (See B.“CDPH
Staffing/Surveyors,” page2.1, for more information regarding HFENs.)
The surveyors will inspect floor-to-floor separations, corridor wall construction, smoke
and fire barriers, vertical opening construction, exit stairs and doors, signage, fire alarm
system, sprinkler system, emergency power generator set, emergency lighting, medical gas
storage, electrical outlets, extension cords, flammability of wastebaskets/drapes/etc., fire
extinguishers, corridor obstructions, storage of flammable liquids and gases in laboratories,
fume hood ventilation, and the facility fire plan including fire drill records and staff training.
Waivers
CMS has the authority to grant waivers of LSC and HCFC provisions for facilities participating
in Medicare and Medicaid. If a hospital is unable to resolve a particular life safety deficiency
that was cited during a survey, the hospital can submit a request for a waiver or an
equivalency. CMS must find that (a) if the LSC were rigidly applied it would result in an
unreasonable hardship and (b) the deficiency does not adversely affect patient health and
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safety. Note that the deficiency must have been cited during a survey to be eligible for a
waiver or equivalency. A hospital that wants a waiver or equivalency should review the issue
with its surveyor for inclusion in the Statement of Deficiencies (Form 2567). Only the CMS
regional office can approve a waiver or equivalency request.
Waivers and equivalencies approved by CMS are valid only until the next survey (no more
than 3 years), then the deficiency must be cited again during the survey, and the hospital
must choose to either resolve the deficiency, or submit a new waiver or equivalency request
again. Remember that the decision by CMS to approve a waiver or an equivalency request is
made by an individual. There is no guarantee that the same decision will be made again by
the same individual, or another person in the same position.
Waivers and equivalencies should not be used for minor deficiencies that can be and should
be resolved. Waiver or equivalency requests are appropriate for issues that are truly an
operational or financial hardship to resolve.
A waiver request must include the following information:
1. Hospital name, address and CCN
2. Contact information for hospital representative (name, title, telephone number and
email address)
3. Detailed description of the deficiency, including the section number
4. Explanation of why the hospital cannot resolve the deficiency and whether the
hardship is financial or operational. If financial, provide a budget figure to resolve the
deficiency to demonstrate the hardship.
CMS may also issue a time-limited waiver. This may be appropriate if a hospital has been
cited for a LSC deficiency that it wants to resolve, but cannot do so within the required time
period (60 days of the end of the survey). A time-limited waiver request is, in essence, a
request for an extension date to fix the deficiency. The same process for submitting a waiver
request should be used, except instead of explaining the hardship in resolving the deficiency,
the hospital explains the modifications or actions are required to resolve the deficiency.
The hospital should include a copy of a contract with a vendor, building permits, and/or
construction schedules to prove corrective action is underway.
An equivalency request is an NFPA document that scientifically demonstrates an equivalent
level of safety by assessing the remaining features of life safety through a mathematical
formula. An approved equivalency is valid only until the next survey. Hospitals will likely need
to hire an experienced consultant to conduct the required engineering study and help them
prepare the equivalency request.
Resources
A complete discussion of the LSC and LSC surveys is beyond the scope of this manual.
Hospital facility managers should review 42 C.F.R. Section 482.41 (Physical Environment
CoP), Appendix I to the SOM (Survey Procedures and Interpretive Guidelines for Life Safety
Code Surveys) and NFPA publications.
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IV. FEDERAL SURVEY PROCESS
Surveyors will assess the hospital’s compliance with the CoPs for all services, areas and
locations in which the hospital receives reimbursement for patient care services billed
under its CMS Certification Number (see III.“Which Laws are Federal Surveyors Assessing
Compliance With?,” page3.3). This may include inpatient and outpatient services, both
on- and off-campus. The surveyors will accomplish this through observations, interviews and
document/record review. Most of the surveyors will be from CDPH, which has a contract
with CMS to provide surveyor services (see B.“CDPH Staffing/Surveyors,” page2.1, and
I.“CMS Organizational Structure and Staffing,” page3.1, for more information).
Although surveys generally occur during daytime working hours (Monday through Friday),
surveyors may conduct the survey at any time, including evening and weekends. All surveys
are unannounced. A hospital that refuses to allow immediate access to the premises and
relevant documents to a State Survey Agency or CMS surveyor(s) upon reasonable request
may be excluded from participation in the Medicare and Medicaid programs [42 C.F.R.
Sections 488.7, 489.53 and 1001.1301]. (Regulations discussed in this manual regarding the
federal survey process may be found at 42 C.F.R. part 488, subpart A.)
Before the survey team arrives at the hospital, they will have familiarized themselves with
the hospital’s ownership, physical plant, previous survey results, waivers and variances that
exist, types of services offered, media reports, the hospital’s website, complaints and other
information.
A. Overview
The survey process, in general, consists of an entrance conference, observations by the
surveyor(s) and an exit conference. After the exit conference, the hospital will develop
preliminary corrective action steps while the surveyors are writing up their survey findings on
the CMS-2567 form. After the hospital receives its 2567 form, the hospital will prepare and
submit its final plan of correction. Finally, the surveyors may (and in some cases, must) return
to the hospital to verify that the plan of correction was implemented. Information about these
steps in the survey process is provided below.
In many parts of this manual, the most extensive type of survey is described — a full state
licensure or federal certification or validation survey, which can be a week-long (or longer)
experience with multiple surveyors in the facility at the same time, with potentially serious
consequences. The hospital will need to devote significant high-level staff time responding to
this type of survey. However, many surveys will be abbreviated versions of those described in
this manual, and the hospital will want to adjust its response and procedures accordingly.
B. Entrance Conference
The entire survey team will enter the hospital together. Upon arrival, the surveyors will
usually go to a front desk or to Administration, present identification (which they expect
to be checked) and advise the hospital CEO (or designated person in charge) of their
intention to conduct a survey. For a validation survey, a surveyor will present the hospital a
letter announcing the validation survey, as well as a form titled “Authorization by Deemed
Provider/Supplier Selected for Accreditation Organization Validation Survey.” The hospital’s
CEO or other authorized individual will be asked to sign the authorization document,
acknowledging that the hospital must permit the validation or complaint survey to take place,
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as well as state agency monitoring of the correction of any substantial noncompliance found
through the survey. If the hospital refuses to permit the survey to take place, the surveyor will
inform the hospital that its deemed status will be removed (if it has deemed status) and the
hospital may be subject to termination from the Medicare and Medicaid programs.
The hospital should issue temporary IDs to the surveyors if this is hospital policy. The
surveyors will then initiate an entrance conference during which they introduce themselves,
identify the team leader, describe the purpose of the survey, and provide an overview of the
expected procedure. According to the SOM, the surveyors will provide information about the
following:
1. Clarification that all hospital areas and locations under the hospital’s CMS
Certification Number may be surveyed.
2. Explanation that all interviews with patients, staff and visitors will be conducted
privately unless otherwise requested by the interviewee.
3. Discussion of how the facility will assure that the surveyors are able to obtain copies
of records and other documentation needed during the survey.
4. Identification of the names and contact information of key staff members.
5. Discussion of the estimated time, location, and possible attendees of any meetings
that might be held during the survey.
6. Proposal of a tentative date and time for the exit conference.
See A.“First Impressions,” page4.7, and B.“Entrance Conference,” page4.7, for tips
regarding the entrance conference.
If the survey is for the purpose of investigating a complaint, the surveyors will mention only
the general nature of the complaint. For example, if the complaint is that a patient developed
a life-threatening infection in a post-surgical wound, the surveyors will be vague, merely
indicating that it is a situation related to infection control for surgical patients. They will not
identify the complainant. However, the hospital may be able to guess the complainant from
the patient records that the surveyors choose to review.
At the end of the entrance conference, the survey team will conduct its own team meeting
without hospital representatives present.
What to Provide the Survey Team
The materials requested by the surveyors will depend on the type and focus of the survey.
Generally, the survey team will ask for the following:
1. A conference room or other location where the team may meet privately during
the survey. The room must be lockable and have appropriate power outlets/strips,
internet access, and a printer.
2. A telephone for team communications, preferable in the team meeting location.
3. A list of current inpatients, including each patient’s name, room number,
diagnosis(es), admission date, age, attending physician, and other significant
information. The surveyors will want this information ASAP, and in no case later than
3 hours after the request is made.
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4. A list of department heads with their locations and phone numbers. (It’s a good idea
to also provide the name and phone number of the hospital’s LCA team leader.)
5. A copy of the facility’s organizational chart.
6. The names and addresses of all off-site locations operating under the same CMS
certification number. (This is the number used to bill hospital services to Medicare; a
rural health clinic or skilled nursing facility will probably have a different certification
number.)
7. The hospital’s infection control plan.
8. A list of all employees.
9. The medical staff bylaws and rules and regulations.
10. A list of contracted services.
11. A copy of the facility’s floor plan, indicating the location of patient care and
treatment areas. (It’s a good idea to prominently indicate on the floor plan where the
surveyors’ conference room or work room is located, and the telephone number(s)
of the phones in the room.)
12. Any waivers the hospital has obtained.
13. For state surveys, the surveyors will want copies of program flexes that have been
granted. CDPH has prepared a list of documents it may request for relicensing
surveys, available at https://www.cdph.ca.gov/Programs/CHCQ/LCP/CDPH%20
Document%20Library/GACHRLS-GeneralEntranceList.pdf.
14. CDPH surveyors must have a flu vaccine or wear a mask in designated patient
care areas during the annual flu season. CDPH employees who have received a flu
vaccine will have a sticker on their CDPH identification badge. If the surveyor hasn’t
been vaccinated, the hospital must provide a mask. (See All Facilities Letter 20-82,
dated Oct. 30, 2020, for more information.)
In a hospital using electronic health records (EHRs), the survey team will request that the
hospital provide a terminal(s) where the surveyors may have unrestricted access to the
medical records. In the case of a hospital with terminals at multiple care locations, surveyors
must be provided access to a terminal at each care location (see “Access to EHRs,”
page3.20). The hospital must designate a staff member who is proficient at using the EHR
to help the surveyors.
If the surveyors are conducting an EMTALA complaint survey, they will ask for the following
information as they deem appropriate:
1. Dedicated ED logs for the past 6-12 months;
2. The dedicated ED policy and procedures manual;
3. Consent forms for transfers of unstable individuals;
4. Dedicated ED committee meeting minutes for the past 12 months;
5. Dedicated ED staffing schedule (physicians for the past 3 months and nurses for
the last 4 weeks) or as appropriate;
6. Bylaws/rules and regulations of the medical staff;
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7. Minutes from medical staff meetings for the past 6-12 months;
8. Current medical staff roster;
9. Physician on-call lists for the past 6 months;
10. Credential files, including the director of the ED and ED physicians;
11. QAPI plan;
12. QAPI minutes;
13. List of contracted services;
14. Dedicated ED personnel records;
15. In-service training program records;
16. Ambulance trip reports and memoranda of transfer; and
17. Ambulance ownership information and applicable state/regional/community EMS
protocols.
The hospital should have a person assigned to complete each of the tasks or obtain the
information listed above as soon as possible upon notification of the surveyor’s presence.
A back-up person (or more than one) should also be assigned in case the primary person
responsible is sick, on vacation or otherwise unavailable.
C. Surveyors’ Procedures
Sample Size and Selection
The surveyors will review the patient list provided by the hospital and select patients who
represent a cross-section of the patient population and services provided. They may also use
patient logs (ER, OB, OR, restraint, etc.). They usually select patients who are in the facility
during the time of the survey (i.e., open records). This allows them to validate the information
obtained through record reviews with observations and patient/staff interviews.
The number of patients selected for a CMS certification or validation survey depends upon
the hospital’s average daily census. The sample will be at least 10 percent of the average
daily census, but not fewer than 30 inpatients. For small hospitals with an average daily
census of 20 patients or less, the sample should not be fewer than 20 inpatient records.
At least one patient from each nursing unit (e.g., med/surg, ICU, OB, pediatrics, specialty
units, etc.) will be chosen. In addition to the inpatient sample, a sample of outpatients will be
selected.
If a complaint is being investigated, the surveyors will include patients who are part of the
complaint. Issues identified through complaints may be an area of focus when selecting the
patient sample. Approximately 20-50 records will be reviewed for an EMTALA complaint
survey.
The surveyors will give patients (and any staff or visitors that are interviewed) in the sample a
unique identifier. The surveyors are required to keep identifying information (medical record
numbers, Social Security numbers, billing record numbers, care unit, etc.) on a separate
identifier list.
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Comprehensive Review
The surveyors will undertake a comprehensive review of care and services received by
each patient in the sample. A “comprehensive review” includes all three methods of
surveying for each patient: observations of care and services provided, interviews with the
patient/family/staff, and medical record review (described below).
During the comprehensive review, the surveyors will look at actual and potential patient
outcomes, as well as required processes. They will assess the care and services provided,
including the appropriateness of the care and whether the care provided meets the needs of
the individual patient.
Information Gathering by Surveyors: Observation/Interviews/Record Review
Observation
Surveyors will visit patient care settings, including inpatient units, outpatient clinics,
anesthetizing locations, emergency departments, imaging, rehabilitation, remote locations,
satellites, etc. They will also visit areas where patients are not present, such as dietary,
laboratory, central supply, etc.
The SOM directs the surveyors to:
Maintain open and ongoing dialogue with the facility staff throughout the survey
process. Conferences with facility staff may be held in order to inform them of
survey findings. This affords facility staff the opportunity to present additional
information or to offer explanations concerning identified issues.
However, the SOM goes on to state that, “Survey information must not be discussed unless
the investigation process and data collection for the specific concerns is completed.”
The SOM states that surveyors are encouraged to station themselves as physically close to
patient care as possible. The surveyors are told to pay particular attention to the following:
1. Patient care, including treatments and therapies in all patient care settings;
2. Staff member activities, equipment, documentation, building structure, sounds and
smells;
3. People, care, activities, processes, documentation, policies, equipment, etc., that
are present that should not be present, as well as those that are not present that
should be present;
4. Integration of all services, such that the facility is functioning as one integrated
whole;
5. Whether quality assessment and performance improvement (QAPI) is a facility-wide
activity, incorporating every service and activity of the provider and whether every
facility department and activity reports to, and receives reports from, the facility’s
central organized body managing the facility-wide QAPI program; and
6. Storage, security and confidentiality of medical records.
Surveyors are advised to have observations verified by the patient, family, facility staff,
another survey team member, or by another mechanism. For example, if a surveyor finds an
outdated medication in the pharmacy, the surveyor may ask the pharmacist to verify that the
drug is outdated.
Patients have the right to decline to be observed (see “Patient Privacy Rights,” page3.22).
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Patient and Employee Interviews
Surveyors will conduct informal interviews throughout the duration of the survey. The SOM
directs surveyors to, among other things, do the following:
1. Maintain detailed documentation of each interview conducted. Document the
interview date, time and location; the full name and title of the person interviewed;
and key points made and/or topics discussed. To the extent possible, document
quotes from the interviewee.
2. Interviews with facility staff should be brief. Use a few well-phrased questions to
elicit the desired information. For example, to determine if a staff member is aware
of disaster procedures and his/her role in such events, simply ask, “If you smelled
smoke, what would you do?”
3. When interviewing staff, begin your interviews with staff that work most closely with
the patient.
4. Conduct patient interviews regarding their knowledge of their plan of care, the
implementation of the plan, and the quality of the services received. Other topics for
patient or family interview may include patient rights, advanced directives, and the
facility’s grievance/complaint procedure.
5. Interviews with patients must be conducted in privacy and with the patient’s prior
permission.
6. Use open-ended questions during your interview.
7. Validate all information obtained.
Staff interviews may assess the staff’s knowledge of the patient’s needs, plan of care and
progress towards goals. Interviews may also assess the staff’s knowledge of the hospital’s
policies and procedures as well as the staff’s clinical proficiency. Staff are allowed to have
their supervisor (or another hospital representative) present during the interview. However,
the hospital cannot insist that a hospital representative be included in every staff interview.
Employees have the right to discuss possible regulatory violations or patient safety concerns
with surveyors privately during a CDPH investigation or survey [Health and Safety Code
Section 1278.5].
Patient interviews will focus on the patient’s condition, reason for admission, quality of care,
and the patient’s knowledge of their plan of care. For example, a surgical patient may be
asked about the process for preparation for surgery, the patient’s knowledge of and consent
for the procedure, pre-operative patient teaching, post-operative patient goals and the
discharge plan. Family members may be interviewed if appropriate (for example, for pediatric
patients), as well as ambulance workers or other witnesses.
Patients, family members and other witnesses have the right to decline to be interviewed (see
“Patient Privacy Rights,” page3.22).
Document/Record Review
Surveyors may inspect both written and electronic records, including, but not limited to:
1. Patient clinical records;
2. Personnel files;
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3. Credentialing and privileging files;
4. Equipment maintenance records;
5. Staffing documentation;
6. Policy and procedure manuals; and
7. Contracts.
Surveyors will make or request photocopies of documents needed to support survey findings
(the surveyors may need access to a photocopier where they can make their own copies).
The surveyors are required to make the hospital a copy of all items they photocopy if the
hospital so requests — the hospital should make this request in a clear manner. If a hospital
employee makes copies for surveyors, the employee should make an extra set for the
hospital’s survey file.
A hospital may be terminated from participation in the Medicare and Medicaid programs
if it fails to permit examination or photocopying of any records or other information by,
or on behalf of, CMS, as necessary to determine or verify compliance with participation
requirements [42 C.F.R. Section 489.53(a)(13)].
Peer Review Documents
CDPH and CMS take the position that they are legally entitled to access peer review
information, even if it is protected from discovery during court proceedings by the California
Evidence Code. There is some legal support for this position, as CDPH and CMS must
assess whether the hospital is complying with regulations governing the medical staff, the
hospital governing body, and quality assurance. CMS, in particular, reminds hospitals that as
a federal government agency it need not recognize this state law. CMS has the authority to
exclude hospitals from participating in Medicare if they fail to provide information that CMS or
the State Survey Agency (CDPH) finds necessary to determine Medicare payment liability or
compliance with the Conditions of Participation [42 U.S.C. Sections 1320a-7(b)(11) and (12)].
If CMS or CDPH requests peer review information protected by Evidence Code Section
1157 during a survey, the hospital should clearly indicate every report, document and
interview that is entitled to 1157 protection, ask the surveyors to note this in their records and
reports, and inform them that the hospital intends to assert the applicability of peer review
protection. Paper and electronic documents can be labeled “Peer Review Document: Do Not
Copy/Do Not Cite in 2567” or something similar. Generally, the surveyors will not copy these
documents. Information that is protected from discovery under Evidence Code 1157 may
remain protected even if it is disclosed to CDPH in the course of an investigation by CDPH
[Fox v. Kramer, 22 Cal.4th 531 (2000)]. CHA’s Consent Manual includes a detailed discussion
of incident reports and various legal privileges in chapter 19.
Attorney-Client Privileged Documents
CDPH and CMS do not assert that they are entitled to access documents protected by the
attorney-client privilege. California courts have held that incident reports may be regarded as
confidential attorney-client communications if the hospital can show that the purpose and
intent of the reports is to provide a confidential communication between the hospital and its
attorney. CHA’s Consent Manual includes a detailed discussion of incident reports and the
attorney-client privilege in chapter 19.
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Patient Safety Work Product Documents
The Patient Safety and Quality Improvement Act (PSQIA) of 2005 was enacted to facilitate
and accelerate improvements in health care quality and patient safety. The law encourages
the voluntary and confidential reporting of events that may adversely affect patients to
Patient Safety Organizations (PSOs). PSOs then aggregate and analyze the data to identify
and better understand underlying causes of risks or ham, and share those findings back to
participating providers.
The PSQIA alleviates health care providers’ fears that trial lawyers, government agencies,
or others might obtain and misuse information about these events by providing federal legal
confidentiality protections to the information that is assembled and reported by providers to
a PSO. The confidentiality protections preempt any state or local law that allows or requires
disclosure of information defined as “patient safety work product.” Thus, surveyors should
not ask hospitals for access to patient safety work product documents, and hospitals should
not provide access to these documents. This applies whether the surveyors are conducting a
state survey or a federal survey.
“Patient safety work product” means any data, reports, records, memoranda, analyses
(such as root cause analyses), or written or oral statements (or copies of any of this material):
1. Which could improve patient safety, health care quality, or health care outcomes;
and
a. Which are assembled or developed by a provider for reporting to a PSO and
are reported to a PSO, which includes information that is documented as
within a patient safety evaluation system for reporting to a PSO, and such
documentation includes the date the information entered the patient safety
evaluation system; or
b. Are developed by a PSO for the conduct of patient safety activities; or
2. Which identify or constitute the deliberations or analysis of, or identify the fact of
reporting pursuant to, a patient safety evaluation system.
However, patient safety work product does not include a patient’s medical record, billing and
discharge information, or any other original patient or provider information; nor does it include
information that is collected, maintained, or developed separately, or exists separately, from
a patient safety evaluation system. Such separate information or a copy thereof reported to a
PSO shall not by reason of its reporting be considered patient safety work product.
A complete discussion of PSOs, including the confidentiality of PSWP, is included in chapter
13 of CHA’s California Hospital Compliance Manual. Hospitals with questions about which
documents may or may not be released to surveyors pursuant to the PSQIA should consult
legal counsel.
Access to EHRs
CMS has sent two memorandums to State Survey Agencies regarding the surveying of
facilities that use electronic health records (EHRs) [S&C 09-53, dated Aug. 14, 2009, and
S&C 14-31 dated May 16, 2014, available at www.cms.gov/Medicare/Provider-Enrollment-
and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html].
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This memo states that if a surveyor requests access to an EHR, the hospital must:
1. Provide the surveyor with a tutorial on how to use its particular electronic system,
and
2. Designate an individual (“navigator”) who will, when requested by the surveyor,
access the system, respond to questions, and assist the surveyor as needed in
accessing electronic information in a timely fashion. The navigator is expected to
have sufficient system access permissions to retrieve complete medical records,
including, when requested, information from built-in audit features that enable
identification of the date, time and author for entries or changes made to the
record. The navigator should know which portions of the medical record, if any, are
not captured in the EHR and to retrieve those paper-based portions as well.
Each surveyor is allowed to determine the EHR access method that best meets the need for
the survey. During the entrance conference in a hospital using EHRs, the survey team must
request that the hospital provide a terminal(s) where the surveyors may access records, and
will establish the process they will follow in order to have unrestricted access to the medical
record. In the case of a hospital with terminals at multiple care locations, surveyors must be
provided access to a terminal at each care location.
If the hospital is unable to provide direct print capability to the surveyor, the hospital must
make available a printout of any record or part of a record upon request in a time frame
that does not impede the survey process. Whenever possible, the hospital must provide
surveyors electronic access to records in a read-only format or other secure format to avoid
any inadvertent changes to the record. The hospital is solely responsible for ensuring that all
necessary back-up of data and security measures are in place.
Providing electronic access to surveyors will not eliminate the need for a surveyor to print
a paper copy or to request a paper copy of certain parts of certain records. However, the
surveyor is required to make reasonable efforts to avoid, where possible, the printing of entire
records. The surveyor should print or request a paper copy of only those parts of records
that are needed to support findings of noncompliance, unless protocols for particular types
of surveys require otherwise (e.g., copying complete medical records to be submitted for an
EMTALA physician review).
CDPH sent a memo to its surveyors following the CMS memo S&C 09-53, stating that CDPH
surveyors should interview administrative staff at hospitals to get a general overview of the
facility’s EHR system and specifically should ask:
1. What records are kept electronically vs. paper?
2. Are electronic records ever purged from the system?
3. Are electronic signatures used?
4. What are the off-site back-up systems, disaster plans and procedures for
downtime?
5. What quality assurance monitoring is performed to ensure there is no unauthorized
access?
CDPH’s memo reminded surveyors that they are not responsible for assessing compliance
with HIPAA privacy and security rules (they are enforced by the federal Office for Civil Rights)
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[DOM 09-06, Oct. 23, 2009]. The surveyors will focus only on breach reporting under
California law (Health and Safety Code Section 1280.15) and whether the hospital’s use of
EHRs is consistent with the Medicare CoPs. Surveyors will:
1. Tour nursing stations and patient rooms to evaluate where terminals are located,
and to see if computer screens showing clinical records are left unattended and
readily observable or accessible by patients/visitors.
2. Determine if the terminals log off within a certain period of time, if they are not being
used.
3. See if passwords are kept in a visible area.
4. Seek evidence that hospital staff shared information from an EHR with unauthorized
individuals.
5. Ask for pertinent policies and procedures.
6. Review EHR system training records for all staff, including registry staff and
consultants.
7. Review signed confidentiality agreements or oaths (including volunteers).
8. Review contracts with third parties that have access to electronic records
(particularly the confidentiality clauses).
State law requires a hospital to provide access to electronically stored patient records to
CDPH staff promptly upon request [Health and Safety Code Section 123149].
Patient Privacy Rights
Surveyors are required to respect patient privacy and maintain patient confidentiality at all
times. Surveyors are required to obtain the patient’s permission prior to observing the patient
receiving treatment. (If the patient lacks the capacity to give permission, the patient’s legal
representative should be contacted for permission.) A patient may decline/refuse to allow
the surveyors to observe and may decline/refuse to be interviewed. A hospital representative
may wish to confirm that the patient is comfortable with the surveyor’s observation and/or
interviewing. The hospital representative may say to the surveyor something like, “Let me go
into the patient’s room with you and make sure the patient is comfortable with this, and then
I’m happy to step out.” The patient may request that a hospital staff member stay with them
during an interview. The surveyors are required to have a hospital staff member witness any
interaction where private parts of the patient’s body are exposed.
Surveyors are required to protect the privacy of patients (and others) who are interviewed or
observed. Their names will not be used in the 2567, and in some cases, even identifiers will
not be used on the 2567 if the interviewee expresses the wish that the hospital not know the
source of the information provided to the surveyor. However, the patient (or other person)
cannot be guaranteed that the information will remain anonymous, because a court may
require that the source of the information be disclosed.
Surveyors may not examine patients by themselves. If it is necessary to determine a patient’s
health status and whether appropriate health care is being provided, the surveyor may (with
patient permission) request that a hospital staff member examine the patient in the surveyor’s
presence.
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Daily Meetings
The surveyors will meet daily (likely at the end of each day), without hospital staff present, to
share their findings and any concerns. They will ask fellow surveyors to be on the lookout for
similar deficiencies or issues in other areas of the hospital. For example, if one surveyor finds
an outdated medication on a crash cart in the emergency department, she will inform her
fellow surveyors of that finding, and the other surveyors may check for outdated medications
on crash carts in other areas of the hospital during the rest of the survey.
The hospital’s licensing, certification and accreditation team should also meet at least daily
(see “LCA Team Meetings During Survey,” page4.9).
D. Decision Making by Survey Team
At the end of the period of observation, interviews and document review, the surveyors will
meet (without hospital staff present) and discuss each applicable CoP. They will share their
findings, evaluate their evidence, and make team decisions regarding compliance with each
CoP.
The federal regulations regarding the survey process state:
The decision as to whether there is compliance with a particular requirement,
condition of participation, or condition for coverage, depends upon the manner
and degree to which the provider or supplier satisfies the various standards
within each condition [42 C.F.R. Section 488.26].
Condition-Level vs. Standard-Level Deficiency
When noncompliance with a CoP is found, the determination of whether the lack of
compliance is at the “standard” or “condition” level depends upon the nature (how severe,
how dangerous, how critical, etc.) and extent (how prevalent, how many, how pervasive, how
often, etc.) of the noncompliance. The determination of whether a hospital has a condition-
level deficiency or a standard-level deficiency is left to the discretion of the survey team and
CMS to determine. There is no black-and-white rule.
A deficiency at the condition level may be due to noncompliance with requirements in a
single standard or several standards within the condition. A deficiency at the condition level
may also be due to noncompliance with the requirements of a single part (tag) representing
a severe or critical health or safety breach. According to the SOM, “Even a seemingly small
breach in critical actions or at critical times can kill or severely injure a patient, and represents
a critical or severe health or safety threat.”
A deficiency at the standard level may occur when there is noncompliance with any single
requirement or several requirements within a particular standard that are not of such
character as to substantially limit a facility’s capacity to furnish adequate care, or which would
not jeopardize or adversely affect the health or safety of patients if the deficient practice
recurred.
It is possible for a hospital to have some standard-level deficiencies yet still be found in
overall compliance with the CoPs. In such a case, the hospital will not be scheduled for
termination from the Medicare and Medicaid programs. Instead, the hospital will be required
to complete a plan of correction (PoC) and be put on State Survey Agency monitoring until
the deficiencies are corrected.
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On the other hand, it is possible that substantial noncompliance with one or more standards
will result in a finding that the hospital is out of compliance with one or more conditions. The
surveyors will make a recommendation to CMS, which has significant latitude to make the
final determination regarding whether the hospital will be found out of compliance with a
condition. It is not possible to remain a participant in the Medicare and Medicaid programs
if there is sustained noncompliance with any condition (see V.“Federal Survey Outcome,”
page3.26).
Deficiency Determined to Have Occurred Prior to Survey
When noncompliance is determined to have occurred prior to an on-site federal survey,
and the hospital states to the surveyors while they are still on-site, that it has corrected the
deficiency, the survey team will consider the following:
1. Is the corrective action superficial or inadequate, or is the corrective action
adequate and systemic?
2. Has the hospital implemented the corrective intervention(s) or action(s)?
3. Has the hospital taken a QAPI approach to the corrective action to ensure
monitoring, tracking and sustainability?
The survey team uses its judgment to determine whether the hospital’s corrective action
is sufficient to prevent the deficiency from recurring. If the surveyors are satisfied with the
corrective action, they will not cite a deficiency. However, if noncompliance is noted during
a survey, even if the hospital corrects it during the survey, it will be cited on the Form CMS-
2567 (see VI.“The Form CMS-2567: Statement of Deficiencies and Plan of Correction,”
page3.30).
E. Exit Conference
At the end of the survey, the survey team will conduct an exit conference. The SOM states
that the purpose of the exit conference is to informally communicate preliminary survey team
findings and provide an opportunity for the interchange of information, especially if there
are differences of opinion. The SOM states that all findings should be discussed at the exit
conference. The hospital should seek as much clarification about deficiencies as needed to
understand what was done wrong and how to correct it. If any complaints or facility-reported
incidents were investigated, the survey team should inform the hospital about their status.
Although the exit conference may appear casual, it is not. The hospital must take this
meeting very seriously. At the exit conference, the surveyors are required to describe all
the deficiencies they found during the survey. Sometimes, however, deficiencies that are
mentioned during the exit conference will not be included in the final report because CMS
may not agree with State Survey Agency findings in the ultimate report. The surveyors
are directed by the SOM to not state whether deficiencies are at the condition-level or the
standard-level — however, it doesn’t hurt to ask.
The hospital determines which hospital representatives will attend the exit conference.
However, as discussed in “Discontinuation of Exit Conference,” page3.25, if an attendee
is hostile or intimidating or misbehaves in some way, the surveyors have the authority to
discontinue the exit conference completely. In such a case, it may be better for the hospital
to agree to exclude the offensive staff member and continue the exit conference.
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During the exit conference, the SOM directs the surveyors to state that “the provider will have
an opportunity to present new information after the exit conference for consideration after the
survey.” The SOM states that:
The provider has a right to disagree with the findings and present arguments
to refute them. Surveyors should be receptive to such disagreements. If
the provider presents information to negate any of the findings, surveyors
should indicate their willingness to reevaluate the findings before leaving the
facility. The survey team’s reasonableness demonstrates their fairness and
professionalism. The degree of receptivity displayed by providers during the
exit conference often depends upon the attitudes and survey style of the
survey team.
However, it is not unusual for the surveyors to discourage the hospital from providing
substantive feedback during the exit conference. Sometimes they will ask if there are any
questions. Usually, though, they expect any disputed items to have been dealt with during
the survey or to await the 2567. This occurs most frequently when the exit conference takes
place late in the day and the surveyors have scheduling or transportation issues.
Nonetheless, if there are known errors of fact or missing information, the hospital should
courteously attempt to get the correct information to the surveyors before they leave the
facility. It may be possible for the hospital to reschedule the exit conference if necessary to
get the information to the surveyors.
It’s worth repeating that the exit conference is intended to share preliminary — not final —
findings. The hospital may offer additional information during the exit conference. Even if the
hospital doesn’t offer additional information, the surveyors may, upon later reflection, decide
to omit some deficiencies mentioned during the exit conference. Official findings will be sent
to the hospital in writing on the 2567 form.
(See E.“Checklist for Exit Conference,” page4.10, for tips regarding the exit conference.)
Complaint Survey Exit Conference
For a complaint survey, the State Operations Manual states that the surveyors should inform
the hospital of the survey findings, including a general description of any deficiencies found.
The description should be detailed enough to inform the hospital of the types of activities that
require corrective action. However, the surveyors are directed not to comment on whether
the deficiencies identified were condition- or standard-level. Surveyors must also not make
reference to any “tags” related to deficiencies identified (see “Tags,” page3.10). They are
also directed not to provide a list of patients interviewed, observed, or whose medical records
were reviewed, and not to identify specific patients whose cases are associated with specific
deficiencies. However, hospitals have the right to request a copy of any documentation the
surveyors copy to support deficiency findings; therefore the hospital should have enough
information after the exit conference to begin corrective actions.
Discontinuation of Exit Conference
The SOM states that it is the general policy to conduct an exit conference at the conclusion
of each survey. However, the SOM also acknowledges that there are some situations that
justify the surveyors’ refusal to conduct or continue an exit conference. For example, the
surveyors may end the exit conference if the hospital is represented by counsel who tries
to turn it into an evidentiary hearing, or if the hospital creates an environment that is hostile,
intimidating or inconsistent with the informal and preliminary nature of an exit conference.
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V. FEDERAL SURVEY OUTCOME
There are three possible federal survey outcomes:
1. No deficiencies. (A “deficiency,” for purposes of federal surveys, means
noncompliance with a Medicare requirement.)
2. Standard-level deficiencies.
3. Condition-level deficiencies.
Each is described below. (See “Condition-Level vs. Standard-Level Deficiency,” page3.23.)
A. No Deficiencies
Obviously, having no deficiencies is the best possible outcome. The hospital is then done
with the survey process — congratulations!
B. Standard-Level Deficiency
If a hospital is found to have only a standard-level deficiency or deficiencies, the hospital
may continue to operate if it has submitted an acceptable plan of correction to the State
Survey Agency [42 C.F.R. Section 488.28]. The plan of correction must provide for achieving
compliance within a reasonable period of time — the SOM describes a reasonable period
of time as “generally no longer than 60 calendar days.” Depending on the nature of the
deficiency, however, the SOM recognizes that some corrections may reasonably take longer
than 60 days (for example, if construction is required), while other corrections may reasonably
be accomplished in a much shorter time. The amount of time allowed for the hospital to
achieve compliance is based on the nature of the deficiency and the State Survey Agency’s
judgment regarding the capacity of the facility to provide adequate and safe care. A resurvey
is not required for standard-level deficiencies. However, the hospital may be monitored by
the State Survey Agency until the hospital achieves compliance. If, during monitoring, the
State Survey Agency finds the hospital out of compliance with a condition, or discovers an
IJ, the hospital may be moved to a termination track (see VIII.“The Termination Process,”
page3.34).
C. Condition-Level Deficiency
If the State Survey Agency discovers a condition-level deficiency in the course of a
complaint/allegation or validation survey, and if CMS agrees, CMS will notify the provider
of the removal of its “deemed status” (if applicable) and place the provider under State
Survey Agency survey jurisdiction. CMS may request a full survey of all CoPs. The regional
office will determine whether a full survey is appropriate after considering the manner and
degree of noncompliance, the hospital’s compliance history, recent changes in the provider’s
ownership or management, whether the resources to conduct a full survey are available in
the time frame needed, and the length of time since the hospital’s last accreditation survey.
Alternatively, the hospital may be put on a termination track (see VIII.“The Termination
Process,” page3.34).
A hospital with a condition-level deficiency cannot be certified based on a plan of correction
or acceptable progress (that is, what the hospital will do). Thus, the hospital will be subject to
a resurvey to confirm compliance based on a credible allegation of compliance (that is, what
the hospital has done to correct the deficiencies) (see A.“Credible Allegation of Compliance,”
page3.33).
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D. Financial Penalties
Under federal law, financial penalties cannot be imposed for violations of the CoPs. However,
financial penalties may be imposed for violations of EMTALA against hospitals for up to
$111,597 per violation ($55,800 for hospitals under 100 beds). Penalties may also be
imposed against individual physicians for up to $111,597 per violation for wrongfully signing
a certification for transfer or failing to respond within a reasonable period of time while serving
on-call, under specified circumstances. (Further details about financial penalties for EMTALA
violations are found in CHA’s EMTALA: A Guide to Patient Anti-Dumping Laws, available
at www.calhospital.org/emtala-manual. See also C.“EMTALA,” page3.10, for general
information about EMTALA requirements.)
Value-Based Purchasing
It is possible that a financial penalty may result if a hospital is cited by CMS for an IJ. CMS
has stated that a hospital that is cited for immediate jeopardy on at least three federal
surveys during the performance period (each time noted on the Form CMS-2567) will be
excluded from its Value-Based Purchasing (VBP) program for the applicable fiscal year.
Because performance periods can vary by measure, CMS has indicated that a hospital cited
for multiple deficiencies during any of the performance periods for a VBP program year will be
subject to exclusion.
CMS has further clarified that the survey end date will be used to assign the citation to
a performance period unless the Form CMS-2567 contains only EMTALA violations (no
violations of CoPs), in which case CMS uses the date the Form CMS-2567 was issued. Two
Form CMS-2567s with IJ citations and the same survey end date (simultaneous surveys) are
counted as one instance of an IJ citation. CMS acknowledges that the survey end date will
often be earlier than the date on which the Form CMS-2567 is issued to the hospital. [42
C.F.R. Section 412.160]
E. Immediate Jeopardy (Federal)
Under federal law, an “immediate jeopardy” (IJ) is “a situation in which the provider’s
or supplier’s noncompliance with one or more requirements, conditions of participation,
conditions for coverage, or conditions for certification has caused, or is likely to cause,
serious injury, harm, impairment, or death to a resident or patient” [42 C.F.R. Section 489.3].
“Likely” means the nature and/or extent of the identified noncompliance creates a
reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment,
or death will occur if not corrected. Serious injury, serious harm, serious impairment or death
are adverse outcomes which result in, or are likely to result in:
1. Death;
2. A significant decline in physical, mental, or psychosocial functioning (that is not
solely due to the normal progression of a disease or aging process);
3. Loss of limb, or disfigurement;
4. Avoidable pain that is excruciating, and more than transient; or
5. Other serious harm that creates life-threatening complications/conditions.
[SOM, Appendix Q]
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CMS has identified three key components of immediate jeopardy:
1. Noncompliance: the hospital has failed to meet one or more federal health, safety,
and/or quality regulations;
2. Actual or likely serious adverse outcome: as a result of the identified
noncompliance, serious injury, serious harm, serious impairment or death has
occurred, is occurring, or is likely to occur to one or more identified patients at risk;
and
3. Need for immediate action: the noncompliance creates a need for the hospital to
take immediate corrective action to prevent serious injury, serious harm, serious
impairment or death from occurring or recurring.
The survey team must consult its district office manager or Sacramento headquarters before
determining that an IJ exists. They may also call CMS and confer with them. If an IJ is called,
the survey team will provide written notice to the hospital, which must immediately mobilize
to address the circumstances deemed to have created the IJ. The survey team must use
the special template found at the end of Appendix Q to notify the hospital of the IJ. Several
consequences can follow. These are addressed below.
The hospital must provide a removal plan to the surveyors as soon as it has identified the
steps it will take to ensure that no patients are suffering or are likely to suffer serious injury,
serious harm, serious impairment or death as a result of the noncompliance. A removal
plan is not the same as a Plan of Correction – the removal plan focuses on immediate
action steps rather than a more thorough, long-term plan that addresses all aspects of the
noncompliance. The removal plan must:
1. Identify the patients who have suffered, or are likely to suffer, a serious adverse
outcome as a result of the noncompliance;
2. Identify all actions the hospital will take to immediately address the noncompliance
and detail how it will keep patients safe and free from serious harm or death caused
by the noncompliance. Unlike a plan of correction, the removal plan need not
completely correct all noncompliance associated with the IJ; rather, it must ensure
serious harm will not occur or recur.
3. Specify the action the entity will take to alter the process or system failure to
prevent a serious adverse outcome from occurring or recurring, and when the
action will be complete.
4. Include a date by which the hospital asserts the likelihood for serious harm to any
patient no longer exists.
Although there is no strict requirement that the IJ be removed prior to the exit conference,
that is certainly the goal a hospital wants to achieve. Removing the IJ before the surveyors
leave will avoid the hospital being placed on the 23-day termination track, and the
requirement to submit a separate written response to the 2567 regarding the IJ in addition to
the response to the condition-level and standard-level deficiencies. Surveyors may use their
discretion to delay the team’s exit until a removal plan is accepted and the IJ is determined to
be removed, if the hospital is capable of removing the IJ while the surveyors are onsite. There
is no requirement, however, that surveyors remain on-site until the IJ is removed.
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The SOM’s Appendix Q, “Core Guidelines for Determining Immediate Jeopardy,” provides
detailed information and lists factors that surveyors should consider in making their decision.
(See “Appendixes,” page3.8, for information about the appendixes to the SOM.)
State law also uses the term “immediate jeopardy.” While state law defines this term only
slightly differently, CDPH has interpreted the term much differently in practice. In addition,
under state law, a deficiency constituting immediate jeopardy may result in a financial penalty.
This is not the case under federal law, unless there is an EMTALA violation or impact on
the hospital’s participation in the Value-Based Purchasing program. (see V.“State Survey
Outcome,” page2.9, regarding the state definition and application of the term “immediate
jeopardy”). CHA has created a chart showing the differences between state and federal IJs;
it may be found at the end of this manual as Appendix HS-15, “Federal vs. State Immediate
Jeopardy Definition and Implementation Comparison.”
Hospital Corrects IJ While Surveyors are On-Site
Even if the hospital corrects the IJ while the surveyors are still on-site, and that correction fully
addresses any condition-level noncompliance associated with the IJ incident, the IJ incident
will still be reported on the Form CMS-2567 — but it will be noted that the deficiency was
removed. The hospital will not be put on a termination track.
The hospital’s Form CMS-2567 response in this circumstance should describe what was
done to correct the IJ (all corrective actions taken), the date of full correction, any monitoring
that may be called for and the hospital employee responsible for maintaining compliance.
Hospital Corrects IJ While Surveyors are On-Site, But Deficiencies Remain: 90-Day
Termination Track
If the hospital corrects the IJ while the surveyors are still on-site, but an associated condition-
level deficiency or deficiencies remain (notwithstanding resolution of the IJ circumstances),
then CMS or the State Survey Agency will cite a condition-level deficiency and the removal of
an IJ on the Form CMS-2567 report, and will place the hospital on a 90-day termination track
(see C.“Condition-Level Deficiency,” page3.26).
If the hospital corrects the IJ while the surveyors are still on-site, but an associated standard-
level deficiency or deficiencies remain (notwithstanding resolution of the IJ circumstances),
then CMS or the State Survey Agency will cite the IJ and the condition-level deficiency, but
show the date of removal. The remaining deficiencies will be cited at the standard level on
the Form CMS-2567 report, and (assuming no other condition-level deficiencies exist) the
hospital will be subject to State Survey Agency monitoring until the deficiencies have been
corrected. The hospital will not be put on a termination track.
(See also “Condition-Level vs. Standard-Level Deficiency,” page3.23.)
Hospital Does Not Correct IJ While Surveyors are On-Site: 23-Day Termination
Track
If the hospital has not corrected the IJ while the surveyors are still on-site, CMS or the State
Survey Agency will issue an IJ and place the hospital on a 23-day termination track. (See
VIII.“The Termination Process,” page3.34.)
If the hospital submits a “credible allegation” that it has corrected the threat, the State Survey
Agency is instructed to resurvey before termination, if possible. A “credible allegation” is one
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that is realistic in terms of the possibility of the corrective action being accomplished by the
time of the credible allegation and indicates resolution of the problem.
If the hospital does not alleviate the threat before day 23, then Medicare participation will be
terminated effective on day 23.
If the hospital alleviates the threat before day 23, but deficiencies still exist at the condition
level, the hospital will shift “tracks” to the 90-day termination track (described at CHA
Appendix HS-8, “Timeline for 90-Day Termination Track”), in effect giving it 67 more days to
bring itself into compliance.
VI. THE FORM CMS-2567: STATEMENT OF DEFICIENCIES AND PLAN
OF CORRECTION
A. Statement of Deficiencies
After the survey, the surveyors will complete the surveyor’s portion of the Form CMS-2567,
“Statement of Deficiencies and Plan of Correction” (a copy of this form is found at the back of
this manual as CHA Appendix HS-7 and at http://cms.gov/cmsforms/downloads/CMS2567.
pdf). The CMS-2567 is the record of the survey where the survey team documents and
justifies its determination of compliance or noncompliance.
Each surveyor will draft his or her section of the CMS-2567, so the style and detail may vary
within the document. The State Survey Agency (CDPH) is not required to include all of the
deficiencies mentioned during the exit conference. However, the State Survey Agency is not
supposed to include any deficiencies that were not mentioned during the exit conference.
(A recording of the exit conference may prove critical in documenting such discrepancies for
an informal or formal appeal. See “Consider Recording the Exit Conference,” page4.11.)
The state surveyors will send the CMS-2567 to the CMS regional office for review before the
hospital receives it.
CMS may accept the CMS-2567 as written, or may work with the State Survey Agency to
make changes; CMS clearly has the authority to reject and/or modify State Survey Agency
recommendations. CMS makes the ultimate decision regarding which, if any, conditions
and standards are not met. After CMS has approved the CMS-2567, CMS will mail it to
the hospital. It is supposed to be sent to the hospital within 10 working days after the exit
conference. However, this deadline is frequently missed. CMS is also supposed to alert the
hospital of the pending report as soon as possible in the case of an IJ, and within 30 days for
other cases. CMS may phone the hospital and fax the CMS-2567. (If CMS calls, the hospital
should request that CMS fax the CMS-2567 as soon as possible. Be aware that the CMS-
2567 can be very lengthy — sometimes 150 pages or more, since CMS uses only a small
part of each page.)
The Form CMS-2567 is a five-column document:
1. The first and third columns (identical) include the tag associated with each deficient
condition and standard. These tag numbers are found in the State Operations
Manual appendix for the applicable facility or service (see “Tags,” page3.10, for
more information about tags).
2. The second column includes the following:
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a. A cite to the regulation. The Code of Federal Regulations citation refers to the
actual standard or condition at issue as it is stated in the federal regulations.
b. An explicit statement that the condition or standard is not met and how that
determination was made.
c. A detailed description of the findings. The statement of the evidence
describes the circumstances the surveyors found that led them to conclude
that a deficiency exists. The statement may be short or lengthy and may be
broken out into separate findings that separately or together demonstrate
noncompliance. It is not unusual for this statement to be highly repetitive and
difficult to follow. Be careful to take the time to read each finding to ascertain
what exactly is being cited as a deficiency and what may be superfluous
information.
• In a condition tag, each finding is usually followed by a reference to the
standard tag implicated.
• In a standard tag, if an interview supported the finding, the details of that
interview will be described, but the form will usually not identify specific
individual interviewees or patients (because of confidentiality issues and
the fact that the Form CMS-2567 is a public document.) That is why the
suggestions for documentation during the survey are so important (see
chapter 4). Also, if the hospital has failed to abide by one of its policies and
procedures, then that particular policy will be mentioned and summarized
to further demonstrate the deficiency.
3. The fourth and fifth columns of the Form CMS-2567 are blank when the hospital
receives it. While column four is called “Plan of Correction,” the actual response
required for this column may be a plan of correction (meaning the steps the hospital
has already taken and the steps the hospital will take after the 2567 response is
submitted to achieve compliance) or a “credible allegation of compliance” (meaning
all steps to correct deficiencies have been completed) (see A.“Credible Allegation
of Compliance,” page3.33), depending on the type of survey, the findings and the
instructions in the cover letter. (See chapter 5 for more information on preparing the
hospital’s response.)
The hospital’s response is usually due to the State Survey Agency (CDPH) within 10 calendar
days after the hospital receives it.
B. Cover Letter From CMS Accompanying CMS-2567
The Form CMS-2567 is usually accompanied by a cover letter from CMS. Like the CMS-
2567, this is usually a template that CMS tailors to fit the circumstances particular to the
hospital in question. The cover letter is a critical document and must be reviewed very
carefully. The letter includes the following information:
1. Termination Date. If the hospital is found out of compliance with one or
more CoPs, the cover letter will state the ultimate date that the hospital’s CMS
certification will terminate if the hospital does not come back into compliance in
the required amount of time. The cover letter will also include the date that CMS
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will give notice to the public regarding the termination (see C.“Public Notice,”
page3.36).
2. Date Hospital’s Response is Due. This date is usually a fairly quick turnaround
(10 calendar days normally). If the date falls on the weekend or a holiday, be sure to
get CDPH/CMS confirmation that receipt of the hospital’s CMS-2567 response by
the next working day is acceptable. CMS may be willing to extend the deadline by a
few days; if so, the extension should be documented.
3. Review of Hospital’s Response/Right to Resurvey. The CMS cover letter will
explain that CMS will authorize the State Survey Agency to perform a resurvey only
if the hospital’s CMS-2567 response is timely, responsive to all deficiencies, and
credible.
4. Ability to Resurvey. Some CMS cover letters explain the process that would
occur if authorities could not resurvey the hospital prior to the termination date. This
language is disturbing because it ignores CMS prescribed timelines. Legal counsel
should be consulted immediately if the hospital’s cover letter includes this language.
5. CMS and/or State Survey Agency Contact. The cover letter should include a
contact name and phone number that the hospital may call with questions.
6. List of Noncompliance Conditions. This list summarizes the CoPs with which
the hospital is not in compliance, if there are any. The Form CMS-2567 may
include standards that the hospital has not complied with that, although they are
deficiencies, do not cause the hospital to be out of compliance with the entire
condition.
7. Elements to Address in the Hospital’s Response. The cover letter will spell
out specific elements that CMS expects the hospital to address in its CMS-2567
response, for each deficiency. Be careful — these elements vary with each cover
letter. There is no one formula to a hospital’s CMS-2567 response because CMS
sometimes alters the required elements for the hospital’s response.
These variances in cover letter instructions can further complicate the hospital’s move from
its preliminary response/plan of correction to its final CMS-2567 response/plan of correction.
The important point here is that the hospital’s CMS-2567 response must specifically address
each point listed in the cover letter. (See chapter 5 for more information on preparing the
hospital’s response.)
C. Plan of Correction
Chapter 5 contains information about steps to take after the survey has concluded, including
initial steps to take immediately after the exit conference, developing preliminary corrective
action steps, and drafting the Plan of Correction.
D. Public Availability of CMS-2567
The Form CMS-2567 is made available to the public no later than 90 calendar days following
completion of the survey. The purpose of disclosure is to notify the public of the hospital’s
deficiencies and the actions the hospital is taking to remedy them. If the federal government
receives a Freedom of Information Act request, the Form CMS-2567 may be released much
sooner than the usual 90 days. Because of this, the hospital should be prepared for media
inquiry as soon as the survey ends (see D.“News Media,” page5.3).
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The Association of Health Care Journalists posts deficiencies on CMS-2567s from complaint
investigations on its website at www.hospitalinspections.org. The database is searchable
by state, city or key work (such as “abuse” or “medication error.”) However, the hospital’s
response or plan of correction is not included.
VII. CDPH/CMS ACTIONS AFTER POC SUBMITTED
A. Credible Allegation of Compliance
Upon receiving the hospital’s 2567 response, the surveyors must determine whether
the hospital has made a credible allegation of compliance. A “credible allegation of
compliance” is a statement or documentation:
1. That is realistic in terms of the possibility of the corrective action being
accomplished between the exit conference and the date of the allegation of
compliance (for example, the date of the hospital’s plan of correction); and
2. That indicates resolution of the problems.
The SOM states that the alleged corrective action:
1. Should be detailed;
2. Must have removed the deficiency; and
3. Must be of the kind that could have been accomplished between the survey date
and the date of the allegation of compliance (the date of the hospital’s plan of
correction).
Sometimes CMS will approve the PoC without a resurvey. Other times, a resurvey is required.
CMS will grant a resurvey only if the State Survey Agency determines that the hospital has
made a credible allegation of compliance in its 2567 response.
CDPH and CMS are not required to communicate to the hospital when a determination
has been made regarding whether the hospital has successfully made a credible allegation
of compliance. Often the only confirmation the hospital receives that such a determination
has been made is the appearance of surveyors to resurvey. Nonetheless, if too much time
passes without word (how much is too much will depend on the circumstances, whether
termination dates are impending, etc.), the hospital should call CDPH and/or CMS to ask the
status of the survey process and to specifically ask if a credible allegation of compliance has
been found or if any additional information or clarification is needed. If CMS has decided to
approve the PoC without a resurvey, the hospital may wish to request a confirmation letter.
B. State Monitoring
CMS may place a hospital on “state monitoring.” This refers to visits by the State Survey
Agency to oversee a hospital’s compliance status:
1. During bankruptcy, when CMS authorizes such visits.
2. After a change of ownership, when CMS authorizes such visits.
3. During or shortly after removal of an IJ when the purpose of the visit is to ensure
the welfare of patients by providing an oversight presence, rather than to perform a
structured follow-up visit.
4. In other circumstances, when CMS authorizes such visits.
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C. Resurvey
When CMS believes that the hospital’s 2567 response has made a credible allegation of
compliance, the hospital may be entitled to a resurvey, depending on which track the hospital
is on and where the hospital is in the investigation process. Because it is not always clear
when the hospital is entitled to a resurvey, the hospital should pin down CMS on this subject
during telephone calls or during the survey itself. (The terms “resurvey,” “revisit,” and “revisit
survey” are used interchangeably.) If CMS determines that a resurvey is needed, the hospital
should request a prompt resurvey from CMS/CDPH well before the threatened termination
date (if applicable). Communication with CMS an CDPH can be critical regarding the timing
of the resurvey in relation to the hospital’s decertification. If the resurvey process is not
completed before the deadline, the hospital may wish to consider judicial action to halt or
delay the termination (see B.“Filing a Lawsuit,” page3.38). On rare occasions, CMS has
extended the termination date for hospitals, but this is discretionary and a hospital should
not rely on this option. (For a complaint survey requiring a resurvey, the resurvey should take
place within 45 days of the complaint survey if no full survey is required by CMS.)
The scope of the resurvey will also vary depending on which track the hospital is on and
where in the process the resurvey occurs. The resurvey may be a full survey of all CoPs or
limited to reviewing only those CoPs previously found out of compliance. Even if the scope
is limited, the surveyors have the authority to cite the hospital for other deficient CoPs that
they observe. This is because the hospital is required to be in compliance with all CoPs at all
times.
The resurvey process is very similar to the initial survey. Ideally, the survey team will be
smaller, the length of the survey will be shorter, and any resulting 2567 report will be shorter.
However, the hospital should not be lulled into a secure feeling by the scaled-back nature
of some resurveys. The surveyors themselves may make the resurvey process more casual
(e.g., coming out on different days rather than as a team, not holding an exit conference,
etc.). The SOM does not support such actions, particularly with respect to the exit
conference. This is not an optional meeting, but part of CMS policy. If the surveyors fail to
hold an exit conference but still submit a CMS-2567 Statement of Deficiencies, the hospital
should work with its attorneys on how best to respond.
Following a resurvey, the surveyors will again produce a 2567 report detailing any deficiencies
found. Upon receiving the report, the hospital must undertake all the same steps to respond
as they did with the original report. In preparing a response the hospital should also review its
prior responses. If prior corrective action steps and monitoring were not sufficient to correct
the problem, then obviously the same response will not suffice. The hospital should infer that
it is expected to take a more aggressive approach to solving the problem and eliminating the
deficiency.
VIII. THE TERMINATION PROCESS
CMS may terminate a hospital’s participation in the Medicare and Medicaid programs
because of noncompliance with one or more CoPs or failure to provide an acceptable plan
of correction for noncompliance with other requirements (such as violations of EMTALA and
other obligations in the provider agreement). There are other reasons for termination, such as
billing irregularities, that are not related to surveys and thus beyond the scope of this manual.
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The notice (letter) of suspension or termination of a hospital’s provider agreement can be
23 days (if the violations constitute an immediate jeopardy) or 90 days (if the violations do
not constitute immediate jeopardy), as described below. When one or more condition-level
deficiencies are identified during a survey, the State Survey Agency (CDPH) is required to
send the notice and a Form CMS-2567, “Statement of Deficiencies and Plan of Correction,”
report to the hospital within 10 working days. (CDPH does not always adhere to its deadline.)
The hospital then has 10 calendar days to submit its response. (See IV.“Drafting the
Hospital’s Final 2567 Response and PoC,” page5.7, for more information on preparing the
hospital’s response.)
When an immediate jeopardy to patient health or safety is documented, the State Survey
Agency and the CMS Regional Office will complete termination procedures within 23
calendar days. The termination procedures will be postponed or stopped only if compliance
is achieved and documented through an on-site resurvey. If the hospital makes a credible
allegation of compliance, the State Survey Agency is required to conduct a resurvey prior to
termination if possible. (See CHA Appendix HS-9, “Timeline for a 23-Day Termination Track,”
for a timeline of important steps in the 23-day termination process.)
When a hospital is out of compliance with one or more CoPs (that is, condition-level
deficiencies exist), but the noncompliance does not constitute immediate jeopardy, the State
Survey Agency and CMS will complete termination procedures within 90 calendar days.
The termination procedures will be postponed or stopped only if compliance is achieved
and documented through an on-site resurvey. If the hospital makes a credible allegation of
compliance, the State Survey Agency is required to conduct a resurvey. The resurvey will
determine whether the hospital is in fact in compliance, or if it has achieved acceptable
progress. A second resurvey may be conducted between the 46th and 90th calendar days
after the survey, if necessary, and if the hospital submits a second credible allegation of
compliance. (See CHA Appendix HS-8, “Timeline for a 90-Day Termination Track,” for a
timeline of important steps in the 90-day termination process.)
The termination process will not be postponed to accommodate informal hearings or
meetings or to give the hospital additional time to achieve compliance. However, informal
hearings or meetings must take place within these time limits as deemed appropriate by the
CMS Regional Office. The termination process will also not be postponed for changes of
ownership, receivership or any other cause not explicitly required by law.
The State Survey Agency may switch from the 90-day procedures to the 23-day procedures
at any time there is an immediate threat to patient health and safety.
A. Notice of Termination
As noted above, a condition-level deficiency, as well as any circumstance found to create an
immediate jeopardy, may cause CMS to initiate termination of provider certification.
In such case, CMS must notify the hospital in writing [42 C.F.R. Section 498.20]. The
notification must include at least the following information:
1. The basis or reasons for the decision to terminate.
2. The effect of the decision to terminate.
3. Information regarding the hospital’s right to a hearing.
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B. Hospital’s Response
The hospital then has three options after receiving a notice of termination:
1. Correct the deficiencies and submit a PoC; and/or
2. Contest the deficiencies and submit a PoC; and/or
3. Contest the deficiencies without submitting a PoC.
Correcting the deficiencies and submitting a PoC the safest alternative. However, a hospital
can attempt to informally contest the accuracy of the findings, but generally success will
only be had at this stage if it can be readily shown that the State Survey Agency got its
facts wrong. If a hospital disagrees with a finding of a cited deficiency, the hospital may, in
lieu of submitting a PoC, state on Form CMS-2567 the factual basis for disagreeing that a
deficiency occurred. Whenever possible, the hospital must reference the specific regulatory
provision involved in the disputed issue and what factual evidence was available at the time
of the survey to demonstrate compliance. The hospital must also provide documented
evidence that successfully refutes the validity of the deficiency. It is not acceptable for the
hospital to provide evidence of corrective actions taken after the survey started as a basis
for removal of a deficiency citation. It also is not acceptable for the hospital to base its
disagreement on a different interpretation of the regulatory requirements than that found in
CMS guidance, or by refuting the professional judgment of the surveyor regarding the level,
extent, scope or severity of the deficiency.
The original termination date will not be changed by the hospital’s disagreement with one or
more of the deficiency citations. The CMS Regional Office reviews all of the documentation,
including the survey findings and the documentation presented by the hospital before making
a determination. If CMS determines that a deficiency did not exist, it is removed from Form
CMS-2567.
The trouble with waiting to appeal the deficiencies is that termination will likely take effect
before the appeal can be conducted. Thus, even if the hospital ultimately prevails, it will
have a break in Medicare certification, causing significant confusion, billing problems and
negative public relations implications. Depending on the facts and circumstances, a hospital
that receives a notice of termination may wish to pursue more than one of the above options
simultaneously (see A.“Effect of an Early Appeal,” page3.38).
C. Public Notice
CMS will place a notice in the local newspaper stating:
MEDICARE NOTICE TO THE PUBLIC
Notice is hereby given that the agreement between the [Hospital/Address], and the
Secretary of Health and Human Services, as a provider of services in the Health
Insurance for the Aged and Disabled Program (Medicare) is to be terminated at the
close of [date of termination].
CMS may use radio or television announcements if publication in the newspaper cannot be
done in a timely manner.
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If CMS receives credible evidence that the cause for the termination has been removed, CMS
will immediately contact the newspaper to stop the scheduled notice. CMS will also publish a
public notice of termination retraction as appropriate. It will state that:
Notice is hereby given that [name and address of facility] has achieved compliance
with the Medicare Conditions of Participation/Requirements for Participation
pertaining to [fill in title of CoP or requirement]. As a result, the Secretary of Health
and Human Services is continuing the agreement with [the facility] in the Medicare
program.
IX. APPEALING A FINAL DETERMINATION TO TERMINATE MEDICARE/
MEDICAID CERTIFICATION
A hospital has the right to appeal a final determination to terminate Medicare/Medicaid
certification. Until such a determination has been made, the hospital is limited to pursuing
such informal options as requesting meetings with key agency officers, seeking clarification
of findings, and otherwise cooperating with CMS and the State Survey Agency (CDPH) to
achieve a mutually satisfactory outcome.
To request an appeal, the hospital must:
1. File a request in writing.
2. Submit the request within 60 days from receipt of notice from CMS of an initial or
revised determination. (An extension may be obtained upon a showing of good
cause.)
3. Identify the specific issues, and the findings of fact and conclusions of law with
which the hospital disagrees.
4. Specify the basis for contending that the findings of fact and conclusions of law are
incorrect.
Failure to comply with these requirements may result in dismissal of the hospital’s appeal. In
addition to meeting the above requirements, the request should:
1. Put CMS on notice of all matters in dispute.
2. Enable the Administrative Law Judge (ALJ) to rule on the relevancy of evidence.
3. Indicate whether facts are at issue, or whether the dispute is limited to legal issues,
in which case a hearing would not be necessary.
At the hearing, CMS has the burden of demonstrating why the hospital should be terminated.
At the conclusion of the hearing, both the agency and the hospital have the right to request a
Departmental Appeals Board (DAB) review if dissatisfied by the decision of the ALJ. A request
for review must usually be filed within 60 days from receipt of notice of the decision and must
specify the issues, the findings of fact or conclusions of law with which the party disagrees,
and the basis for contending that the findings and conclusions are incorrect. The DAB may
dismiss the request or grant a review by a panel of three individuals. Upon review, the DAB
may remand the case to an ALJ or issue a decision. Judicial review is the final option if the
hospital is dissatisfied with the decision of the DAB.
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Once the option to appeal is under consideration, it is crucial that the hospital enlist the
assistance of counsel, if that has not already been done. Counsel should participate in the
drafting of the request and should make sure that no rights are inadvertently waived and that
all of the requirements for the request are met. (See 42 C.F.R. Section 489.53 and Part 498
regarding termination and appeal rights.)
A. Effect of an Early Appeal
Filing an appeal at the earliest possible time after receipt of notice of termination can shorten
the period during which the hospital is technically ineligible to participate in the Medicare and
Medicaid programs. In the best case scenario, the hospital will be found in compliance with
all Conditions of Participation upon resurvey and the request for appeal can be withdrawn.
However, the possibility always exists that the hospital will not be found back in compliance
after the first resurvey, and since there are no statutory or regulatory provisions for securing
an expedited appeal, its exposure is limited by getting the appeal process started early. It is
highly unlikely (if not impossible) that an ALJ will have an opportunity to review the decision
to terminate and issue a decision in time to actually prevent termination. Thus, retroactive
reinstatement is the most the hospital can likely achieve. Limiting the amount of time that the
hospital is decertified is the best way to mitigate damages, including less obvious damages
such as the medical staff losing confidence in the hospital and an adverse public perception.
Submitting an early appeal may have the additional benefit of demonstrating seriousness
on the part of the hospital. It may also cause the agencies to reconsider tenuous positions
and to encourage compliance with time lines and procedures. It also may help maintain
confidence of the medical staff and the public.
The major circumstance in which it may not be feasible to file an early appeal is if the
deficiency is one that will necessarily take time to correct or to get far enough in the
correction process to make a credible allegation of compliance (e.g., a deficiency that
requires entering into contracts and obtaining designs for construction, or training significant
numbers of employees and staff members of a large facility). In such a case, it may be
necessary to carefully assess the earliest point at which a credible allegation of compliance
can reasonably be made. The good faith of the organization is at stake if the credible
allegation of compliance is premature. Obviously, when a 23-day termination is at issue, the
need to move expeditiously cannot be overemphasized.
B. Filing a Lawsuit
If CMS will not provide sufficient time for a hospital to demonstrate compliance with the CoPs
prior to termination of its provider status, a hospital may decide to file a lawsuit seeking to
delay termination. The court will consider the likelihood of irreparable harm to the hospital if
it is terminated from the Medicare program, the likelihood of harm to CMS if the hospital’s
termination is delayed, the likelihood that the hospital’s legal arguments are correct, and the
public interest. A hospital should seek legal counsel immediately upon the first inkling that it
might need to go to court. Time is short in the decertification process, and the hospital must
file the suit before the 23- or 90-day termination track period ends.
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I. Preparing for a Survey ........................................................................................ 4.1
A. Establish a Survey Readiness/Response Team .......................................... 4.1
Identify Key Leaders ....................................................................................... 4.1
Prepare Survey Kits ....................................................................................... 4.1
Establish a Communication Structure ............................................................. 4.1
B. Train Appropriate Personnel ........................................................................ 4.2
Identify and Train Escorts, Scribes and Runners ............................................. 4.2
Train Hospital Staff .......................................................................................... 4.3
Involve the Medical Staff ................................................................................ 4.4
C. Develop Documentation .............................................................................. 4.5
Prepare Informational Binders ......................................................................... 4.5
Prepare Quick-Review Checklists ................................................................... 4.5
Develop Policies and Procedures .................................................................... 4.5
D. Perform Mock Surveys ................................................................................ 4.5
II. During the Survey .............................................................................................. 4.7
A. First Impressions .......................................................................................... 4.7
Greeting the Survey Team ............................................................................... 4.7
Surveyors’ Identification .................................................................................. 4.7
Communication Center ................................................................................... 4.7
B. Entrance Conference .................................................................................. 4.7
C. Communication Within the Facility ............................................................. 4.8
Assign Escorts, Scribes and Runners ............................................................. 4.8
Key Personnel ................................................................................................ 4.9
Debrief All Staff Who Interact With Surveyors .................................................. 4.9
LCA Team Meetings During Survey ................................................................. 4.9
D. How to Handle an IJ During the Survey ...................................................... 4.9
E. Checklist for Exit Conference ................................................................... 4.10
Participants in the Exit Conference ................................................................ 4.10
When to Consult Legal Counsel ................................................................... 4.10
Take Notes During the Exit Conference ......................................................... 4.10
Ask the Surveyors to Identify Tag Numbers, Interviewees .............................. 4.10
Consider Recording the Exit Conference ....................................................... 4.11
Collect Temporary IDs ................................................................................... 4.11
F. How to Handle Unusual Problems with Surveyors .................................... 4.11
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I. PREPARING FOR A SURVEY
The potential for an unannounced licensing, certification or accreditation survey exists every
day. Hospitals should plan carefully for this inevitability. This portion of the manual provides
helpful information about survey preparation and response. The information discussed in this
chapter applies to both state and federal surveys.
A. Establish a Survey Readiness/Response Team
Every hospital should establish a licensing, certification and accreditation (LCA) team and
designate a team leader. This team is responsible for planning for successful surveys, training
staff, responding when surveyors arrive and preparing plans of correction. The LCA team
may include members of the executive staff, medical staff, department heads, medical
directors, medication safety officers, patient safety officers, the compliance officer, the chief
risk officer and the QAPI coordinator. Other key individuals, including legal counsel, may be
added as appropriate.
Identify Key Leaders
Identify key leaders (and back-ups in their absence) from each department and service to
prepare their unit for surveys and to be called if their department or service is at issue or if the
surveyors want to inspect their unit.
Prepare Survey Kits
Prepare survey kits that contain the contact information of LCA staff, key employees, medical
staff members and management of any on-site contracted services. Include the location
and phone numbers of the hospital “command center” (see “Establish a Communication
Structure,”page4.1) and the work room that the surveyors will use.
The LCA team should also have contact information for their CMS/regional office personnel
and for their CDPH district office personnel, including the names of the surveyors’
supervisors, as well as contact information for CDPH Sacramento headquarters, in the
rare event that a problem arises that needs the attention of CMS or CDPH executive
management. Know who is in charge at your district office, and their back-ups during
vacation, sick leave, etc. It is a good idea to have this information in advance so that if
an urgent problem arises, no time is wasted trying to find out which CDPH person/phone
number to call.
The survey kits should also contain any documents, forms or policies necessary or useful for
the hospital’s LCA team.
Establish a Communication Structure
The hospital will want to establish a command center for effectuating communication
throughout the survey. The command center should be set up immediately upon entrance
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of surveyors by a predetermined leader. The command center will be the central hub for
communication and coordination of all survey activities, including producing and copying
documents and scheduling daily briefings. A communication plan should be developed and
tested in advance.
The first priority will be to immediately notify the LCA team leader and team members of the
surveyors’ presence, as well as the staff members responsible for going through the quick-
review checklists (see “Prepare Quick-Review Checklists,”page4.5) and the tasks listed
under “What to Provide the Survey Team,”page3.14. The communication plan should
include a method for verifying that these employees are working on their pre-assigned tasks,
so that a back-up can be contacted quickly if necessary.
The communication plan for other key leaders and the rest of the hospital staff should quickly
be implemented. A representative of the medical staff (a physician) should be notified and
should be available to address any medical staff concerns that may arise.
The hospital will want to alert the staff to the presence of the surveyors by phone, email
and/or text messaging. Consider establishing a phone tree, automated phone message
system, and/or email or text list so that personnel throughout the hospital (inpatient units
and outpatient departments, both on- and off-campus) are aware that surveyors are on-site.
Every department should be notified. Be sure to include in the communication plan how to
alert the next shift that a survey is in progress.
The hospital may wish to make announcements over the public address system, such as,
“Our hospital welcomes the survey team from the California Department of Public Health.”
This announcement can be repeated now and then, especially during shift changes.
B. Train Appropriate Personnel
Identify and Train Escorts, Scribes and Runners
The surveyors have the discretion to allow, or refuse to allow, hospital personnel to
accompany the surveyors during a survey. Surveyors vary widely in this regard. Some will
not permit any hospital representatives to accompany them in the facility. Others don’t care
who or how many people accompany them. How the hospital representatives approach the
surveyors and the survey process may affect the surveyors’ decision in this regard. Obviously,
a surveyor will be more likely to allow a pleasant, helpful staff member to accompany him/her
than a negative, defensive staff member. The hospital should try to assign a personable,
knowledgeable employee who has good judgment and the ability to be assertive when
necessary to accompany each surveyor.
The hospital should identify and train escorts, scribes and runners in advance, as described
below.
Escort
If possible, an escort should accompany each surveyor during the survey. The escort
announces the surveyor’s presence in a cordial and welcoming manner as they make their
rounds throughout the hospital. An experienced clinician with thorough knowledge of the
hospital’s operations makes an ideal escort.
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Scribe
A scribe will document questions and comments from the surveyors during the survey, and
keep track of the medical records, policies and other documents examined or requested by
surveyors during the survey.
Runner
A runner will obtain documents and materials requested by the surveyor during the survey,
and make a copy for the hospital’s file. The runner also alerts the next department or unit of
the surveyor’s anticipated arrival, issues the surveyor is focused on, and any other information
useful to the next department.
Exactly how the escort, scribe and runner function may vary. The scribe and runner can
walk behind the surveyor and escort (so the surveyor hardly even knows they are there). At
times the scribe and runner may be the same person, and when that person has to leave
the vicinity of the surveyor, the escort can assume the scribe’s duties. Depending upon the
unit of the hospital that the surveyor is in, the escort may step back and let the charge nurse
or other unit leader act as an escort. Hospital staff can be flexible in the assignment and
function of escorts, scribes and runners.
(See also “Assign Escorts, Scribes and Runners,”page4.8.)
Train Hospital Staff
Hospitals should train all personnel who may encounter surveyors, including clinical staff,
medical staff, contract staff, volunteers and employees in dietary, pharmacy, laboratory,
central supply, environmental services, etc. Training should include staff in inpatient units
and outpatient departments, both on- and off-campus. Training may be done during new
employee orientation, annual skills training, or during specialized survey readiness training.
Training should include at least the following elements:
1. Basic information regarding who the surveyors are and what the surveyors’ job is.
2. Surveyors should be treated professionally, courteously, and with respect (see
A.“First Impressions,” page4.7).
3. How to respond during surveys. Training should cover obvious do’s and don’ts:
• Do answer questions truthfully and provide facts.
• Don’t give your opinion or babble out of nervousness.
• Avoid acknowledging violations.
• Don’t self-report areas of concern or incidents that the surveyors have not
identified.
• Don’t raise issues that the surveyors have mot asked about.
• Say “Let me find someone to assist you,” as opposed to “I don’t know” or “No
one ever told me that.”
• Understand that your statements may be quoted by surveyors as evidence of
deficiencies.
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4. Make sure employees understand that surveyors are not like police — that is, they
are not asking questions because they think the employee did something wrong.
The surveyors are interested in finding out what the employee knows or how the
employee usually does something.
5. What to do if a hospital staff member feels that a surveyor is behaving in an
intimidating, harassing or inappropriate manner, or is interfering with patient care.
Remember that some employees may feel that surveyors are equivalent to police
officers, authority figures or judges. This may be due more to the employee’s
feelings than the surveyor’s behavior. Nevertheless, if an employee becomes so
nervous at being observed by a surveyor, this may result in a patient care error.
Employees should be taught what to say to the surveyor and whom to call if they
are feeling extremely nervous, flustered or scared.
6. Employees should feel free to use any tools, information or additional staff they
would normally use when doing their job. For example, if a surveyor asks a nurse
to prepare an injection, the nurse should feel free to let the surveyor know that
ordinarily she would get her reading glasses before preparing the injection, and to
go get her reading glasses. (This may not be optimal if the surveyor calls a mock
code, but it is better than preparing an incorrect injection.)
7. Employees should not perform a task at the direction of the surveyor if the
employee does not perform that task pursuant to hospital policy and procedure. For
example, if the hospital’s policy for pediatric codes requires the physician to draw
the medications, the surveyor should not insist that the nurse demonstrate how she
would draw the medications. Again, employees should be trained how to handle
these unusual situations.
8. Patients’ privacy rights with respect to surveyors (see “Patient Privacy
Rights,”page3.22).
9. Staff rights during observation or interviews (see “Information Gathering by
Surveyors: Observation/Interviews/Record Review,”page3.17).
10. Who to debrief after the interaction with the surveyor is over.
In addition, hospital personnel at every entrance should be trained regarding whom to call
when surveyors arrive (days, nights, weekends, holidays, etc.).
The bottom line is that all hospital staff members should be courteous and respectful
to the surveyors at all times, but should also feel empowered to take appropriate
action to maintain safe, high-quality patient care.
Involve the Medical Staff
Involve the medical staff in planning and training for surveys. There should be ongoing
communication about emerging issues with regard to compliance with licensing, certification
and accreditation requirements, as well as how to respond during surveys. Make the
medical staff leadership a part of the hospital’s LCA team both to maintain compliance and
to avoid negative responses from the medical staff when surveyors raise questions. Meet
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with the QAPI committee, quality council, medication safety committee and other medical
staff committees as appropriate. Be sure to schedule training for medical staff officers and
department and service chiefs as the leadership changes over time.
C. Develop Documentation
Prepare Informational Binders
The hospital should prepare binders (or electronic equivalents) in advance containing the
hospital’s patient safety plan, medication error reduction plan, infection control plan, diet
manual, radiology permits (CT, fluoroscopy, brachytherapy, etc.), supporting policies and
procedures and other similar documents. The hospital should determine which information
should be kept in the departments, and which in a centralized location. Procedures should
be in place to ensure that these documents are kept up to date. Educate appropriate leaders
and staff on the contents of the binders and the role they play in the survey process.
Prepare Quick-Review Checklists
Establish checklists for each department to perform a quick review as soon as surveyors
arrive at the hospital (before the surveyors reach the department). The checklists
might address clutter in hallways, expired medications, outdated patient food, restraint
documentation, code cart, staff wearing badges, documentation of consent and H&P,
universal precaution/time out, etc. These quick-review checklists are, of course, in addition to
more detailed planning documents and tools.
Develop Policies and Procedures
The hospital should have policies and procedures regarding surveys that cover required
training, preparation for surveys, procedures during surveys, etc. Note, however, that the
California Department of Public Health (CDPH) may cite hospitals for not complying with
their policies, even if the policies contain requirements that would not otherwise legally be
required. In other words, if a hospital’s policies specify procedures or actions that are not
required by law, the hospital may be cited by CDPH for failure to follow them. Hospitals
should be careful to tailor their policies to the requirements of the law. CHA has developed an
“FAQ on Writing Hospital Policies and Procedures,” reprinted as CHA Appendix HS-13.
D. Perform Mock Surveys
Hospitals should perform various types of mock surveys. These surveys should be
unannounced and the mock survey team should act like, and be treated like, an actual
CDPH survey team. To prepare for federal certification surveys, hospitals should assign
staff to “act like a surveyor” and perform each step in the survey procedures found in the
applicable appendix or appendixes to the State Operations Manual (see B.“State Operations
Manual,” page3.7). To prepare for state surveys, hospitals should assess readiness with
the surveys described under II.“Types of State Surveys,” page2.3. Because surveyors will
review a hospital’s past three years’ deficiencies prior to coming on-site, hospitals will also
want to review past 2567s and evaluate their compliance with their past PoCs. Hospitals
should also review their past three years’ of complaints and entity-reported events (such as
adverse events), because the surveyors will have these in mind, also. Finally, hospitals should
review new laws as well as recent AFLs issued by CDPH, as the CDPH surveyors may focus
on these areas. (See III.“Which Laws are State Surveyors Assessing Compliance With?,”
page2.6, regarding AFLs.)
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During mock surveys, mock surveyors should observe staff performng patient care and other
tasks, interview staff and patients, and perform record review — just as the surveyors will do.
It may be helpful for hospitals that are part of a system — or even unrelated hospitals — to
team up and survey each other. (Unrelated hospitals that consider taking this approach will
need to enter into a business associate agreement to comply with federal privacy laws unless
no patient-identifiable information will be shared.)
Mock surveys should be conducted at least annually, and again three to four months before a
potential survey. Reports should be generated and presented during a mock exit conference.
The hospital’s LCA team is responsible for following up regarding corrective action plans,
auditing, and tracking/trending outcomes.
Hospitals may wish to solicit feedback from staff regarding the mock survey. Internal mock
survey feedback questions may include:
1. The mock survey helped me understand what a real survey would be like
2. The mock survey helped me understand what to do during an actual survey
3. Talking to the mock surveyors was good practice for me
4. The mock survey was helpful in identifying areas to work on prior to our actual
survey
5. The mock surveyors were knowledgeable
6. I learned something new during the mock survey
7. I would like to learn more about the survey process
8. What can we do to improve the survey process?
The first seven questions can have a response such as:
1. Agree strongly
2. Agree somewhat
3. Neither agree nor disagree
4. Disagree somewhat
5. Disagree strongly
The last question should be open response — just include blank space for staff to write their
ideas.
Documentation During the Mock Survey
Documentation during the survey is very important, and this should be practiced during mock
surveys. A common problem that hospitals encounter in preparing the 2567 response is the
inability to identify the precise individual or document to which a deficiency relates. Be aware
that the surveyors also may not keep adequate notes of the individuals or documentation
at issue, or may lose them. It is difficult to prepare an effective response to the 2567 or to
correct obvious surveyor errors without good notes.
Thus, training and mock surveys should include an emphasis on documenting everything that
happens throughout the survey.
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II. DURING THE SURVEY
A. First Impressions
First impressions count! Be cordial and respectful of the surveyors and the survey process.
The surveyors are well aware that hospitals are not completely thrilled to see them. They
know that their arrival means extra work for hospital staff, extra stress and perhaps cancelled
vacations. It will not increase the chances for a successful survey if hospital staff act hostilely,
condescendingly, cynically or defensively with the surveyors who, after all, are just doing their
job. Showing respect for what the surveyors do can improve the entire interaction.
All hospital personnel should take the attitude that the surveyors are partners in achieving
high-quality patient care. The surveyors serve as another set of eyes on quality, to identify
practices that can be improved that the hospital might not have considered. It cannot be
emphasized enough how important it is for the members of the LCA team and other key
leaders to model a constructive attitude toward surveyors. This will accrue to the benefit of
the hospital.
Greeting the Survey Team
The chief executive officer and/or chief operating officer (or their designees in their absence)
should be the “executive greeter” and be available for the entrance conference. Depending
upon the organizational structure of the hospital, this person may also lead the hospital’s LCA
team.
Hospitals may wish to provide parking validation or temporary parking passes to surveyors.
Surveyors’ Identification
Be sure to check the surveyors’ identification, which is issued by CDPH or CMS. Surveyors
are required to show their identification when they arrive at the facility and to wear it (and/or
the hospital-issued ID) at all times they are in the facility. If doubt exists about the identity of a
person claiming to be a surveyor, call the CDPH district office or CMS regional office to verify.
Imposters have attempted to gain access to hospital facilities in the past. If individuals falsely
identify themselves as CDPH or CMS employees in an attempt to access a hospital facility,
notify CDPH, CMS and local law enforcement immediately.
Obtain a business card from each surveyor, and make copies of the cards for each person
on the LCA team. Finally, be sure to attend to appropriate amenities for surveyors — provide
workspace, temporary badges, etc. (See “What to Provide the Survey Team,”page3.14.)
Communication Center
Implement the communication plan as soon as possible. (See “Establish a Communication
Structure,”page4.1.)
B. Entrance Conference
As mentioned above, it is important for the entire hospital staff to be cordial and respectful
of the surveyors and the survey process. This is especially true for hospital staff members
who participate in the entrance conference. The attitude of the hospital representatives at the
entrance conference can set the tone for the entire survey.
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The entrance conference provides a forum for the hospital to coordinate with the surveyors
regarding their survey protocol. The hospital should take careful notes of the entrance
conference. Pay attention to the issues with which the surveyors seem particularly concerned
during the entrance conference. Clarify whether the survey to be performed is a state
survey or a federal survey. This will help the hospital’s response team match any identified
deficiencies to the statutes and regulations implicated, and thus help the hospital develop its
plan of correction.
CDPH uses the same surveyors for both state and federal surveys. Although the
surveyors may be the same people, there are differences in processes and potential
outcomes, as described throughout this manual. To make matters more confusing,
surveyors may figuratively “switch hats” while in the hospital. For example, CDPH
may receive a self-report of an adverse event and begin a state survey. If the
surveyors detect noncompliance with a federal requirement, they may call CMS while
still at the hospital and request authority to conduct a survey on behalf of CMS.
Hospitals should seek clarification from the surveyors if it is not clear whether they
are representing the state or CMS. Hospital should also clarify what type of survey
will take place (see II.“Types of State Surveys,” page2.3 and II.“Types of Federal
Surveys,” page3.2).
As the entrance conference proceeds, try to identify as soon as possible the departments
and services that are at particular issue. Include the applicable department and service
leaders at the earliest appropriate time in the survey process.
At the end of the entrance conference, the hospital should feel free to ask questions or
request clarification about anything related to the survey process. The hospital should also
restate any action steps that either the surveyors or hospital representatives have agreed to
take, any agreements made during the entrance conference, or other key points.
C. Communication Within the Facility
Assign Escorts, Scribes and Runners
Assign an escort, scribe, and runner to accompany each surveyor on the rounds, making
sure they offer whatever assistance and amenities the surveyor requires (see “Identify and
Train Escorts, Scribes and Runners,”page4.2, for a description of roles). Within the
bounds of the survey protocols for privacy for patients, staff and visitors, have the escort,
scribe and runner keep careful track and take notes of:
1. The identity of all individuals (patients, staff, others) whom the surveyors interview or
question.
2. All records the surveyors review, including patient records, logs, policies,
procedures and protocols, and any surveyor comments that relate to a particular
record.
3. All situations in which the surveyors take particular interest, and any comments
surveyors make regarding particular issues.
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Escorts, runners and scribes should track dates and times in their notes. They should be
debriefed as soon as possible when they are finished with the surveyors, while the survey is
still fresh in their minds.
As a finding is discovered, ask the surveyors to cite to the applicable tag number, CoP,
standard and/or condition (for a federal survey) or Title 22 or Health and Safety Code Section
(for a state survey). The surveyors are not required to provide this information at this time in
the process, but it doesn’t hurt to ask for as much information as they will provide.
Don’t be confrontational, but ask questions and advocate, when appropriate, for your
facility’s practices.
Key Personnel
During the survey, there should be key personnel available in the department/unit when the
surveyors are present to ensure a quick and efficient review and to address any questions or
concerns.
Debrief All Staff Who Interact With Surveyors
Debrief each hospital staff member who interacts with a surveyor to learn what issues the
surveyor was interested in and the surveyor’s reaction to what he/she observed. This will help
identify trends and surveyors’ areas of focus.
LCA Team Meetings During Survey
As mentioned under “Daily Meetings,”page3.23, the surveyors will meet daily (often at the
end of each day), without hospital staff present, to share their findings and any concerns.
They will ask fellow surveyors to be on the lookout for similar deficiencies or issues in other
areas of the hospital. For example, if one surveyor finds an outdated medication on a crash
cart in the emergency department, she will inform her fellow surveyors of that finding, and
the other surveyors may check for outdated medications on crash carts in other areas of the
hospital during the rest of the survey.
The hospital’s LCA team should also meet at least daily to identify trends and share any
comments, concerns, issues, or pointed questions raised by the surveyors. The team should
address any problems or potential problems identified by the surveyors as soon as possible,
and throughout the entire hospital, as applicable. For the example given above (surveyor
finds outdated medication on crash cart in emergency department), the hospital should
check all of the other crash carts in the hospital for outdated medications, and check the
hospital’s applicable policies and procedures. The hospital should try to determine whether
the presence of the outdated medication was a fluke, a symptom of a missing or poorly
written policy, or a well-written policy that was not implemented. If it appears that one
employee did not perform his or her job as anticipated, it might be a good idea to check
other responsibilities of that employee. It is important that the hospital undertake this type of
review as soon as possible upon discovery by a surveyor, and make corrections as soon as
possible.
D. How to Handle an IJ During the Survey
As discussed in detail under E.“Immediate Jeopardy (Federal),” page3.27, a hospital should
try to correct any IJs found during a survey before the surveyors leave the facility. By doing
so, the hospital can avoid formally being placed on the 23-day termination track and having
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to submit a separate written response to the Form CMS-2567 write-up of the IJ (if the survey
is a federal survey). It is therefore crucial that the hospital be assertive and persistent in
bringing all corrective action steps to the surveyors’ attention in order to get their feedback
on whether or not the IJ has been cleared and, if not, what else the surveyors require to be
done. Constant communication is important, and an attitude of concern and cooperation is
paramount. (State IJs are handled differently; see D.“Deficiencies Constituting Immediate
Jeopardy,” page2.10, and Appendix HS-15, “Federal vs. State Immediate Jeopardy
Definition and Implementation Comparison.”)
E. Checklist for Exit Conference
At the end of the survey, the survey team will conduct an exit conference to informally
communicate preliminary findings. The hospital will be given the opportunity to provide
additional information. The purpose, content and guidelines regarding the exit conference are
described in E.“Exit Conference,” page3.24. This portion of the manual provides additional
tips.
Participants in the Exit Conference
The hospital determines which hospital representatives will attend the exit conference.
Hospitals should carefully consider which staff members to include. If initial reports indicate
deficiencies in a certain area, the hospital may wish to include management staff from that
area in the exit conference.
The surveyors will note the hospital’s reactions to survey findings/deficiencies. The
participants in the exit conference should maintain a professional and constructive demeanor
at all times. It is appropriate to ask questions, provide additional information to the surveyors,
politely point out any errors surveyors may have made, and to explain the hospital’s
perspective. It is not constructive for hospital representatives to become argumentative,
hostile, or defensive. The surveyors may end the exit conference prematurely if participants
become hostile or intimidating.
When to Consult Legal Counsel
If it appears that the outcome of a survey could result in termination of participation in the
Medicare and Medicaid programs, monetary fines, or other serious repercussions, a hospital
should consider immediately involving a health care attorney experienced in assisting
hospitals with licensing and certification issues. Although legal counsel do not usually attend
the exit conference, a telephone or in-person consultation with experienced counsel can be
very useful in assisting hospital leadership to assess the potential risks and to prepare for and
take best advantage of the exit conference. (See also E.“Consider Involving Legal Counsel
and/or Consultants,” page5.5.)
Take Notes During the Exit Conference
The hospital representatives participating in the exit conference should take note of the
names of the surveyors and which surveyor is speaking about each deficiency or point
described.
Ask the Surveyors to Identify Tag Numbers, Interviewees
Although the surveyors are not required to, nor supposed to, disclose the tag numbers
that may be implicated at this stage of the survey process, it does not hurt to ask for as
much information as they will provide about deficiencies, and which CoPs, tags, and Title
22 or Health or Safety Code provisions are implicated. If there are particular patient records
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or interview situations involved, try to clarify the identity of the patient(s) or interviewee(s)
involved. However, the surveyors are not required to, nor supposed to, disclose the names
of patients or employees. It may be possible to gain enough information from the surveyors
for the hospital to make an educated guess regarding the patient and/or employee, so
the hospital can investigate and remediate any problems. The 2567 is required to contain
sufficient information for the hospital to correct the deficient practice, and to contest the
deficiency if it desires. The hospital may have to wait until it receives the 2567 to get the
necessary information.
Consider Recording the Exit Conference
The hospital may wish to record the exit conference or have a scribe take notes.
Audiorecording the exit conference is permitted, if a copy of the recording is given to the
surveyors at the end of the conference, or the surveyors have the ability to make their
own simultaneous recording. Videorecording is also permitted if it is not disruptive to the
conference, in the opinion of the surveyor(s). Again, a copy must be given to the surveyors
at the end of the conference. It is a good idea to test the recording device(s) prior to the exit
conference.
The decision regarding whether to record the exit conference should be made by the LCA
team, in consultation with risk management and legal counsel. The team should consider
the risks and benefits of recording the conference. If the exit conference is recorded,
the discussion may become more formal and guarded, and the surveyors may be less
forthcoming in sharing information or less willing to change their minds about deficiencies.
The hospital representatives also may be reluctant to have an open discussion and would
want to be careful to avoid admitting liability of any kind.
On the other hand, because the hospital may not receive the 2567 for some time after the
exit conference, the hospital may want to have a complete and accurate source of the
agencies’ findings right away. Handwritten notes and memories may not be sufficient for
this process. If something is confusing, it may be helpful for attorneys/consultants hired by
the hospital to assist in developing the plan of correction to listen to the exact words of the
surveyors. A recording may provide proof that a particular deficiency was never mentioned in
the exit conference; this may be critical in a formal or informal appeal.
If the conference is recorded, the hospital will want to prepare a transcript of the recording
and begin as soon as possible to address any deficiencies identified by the surveyors. It is
not a good idea to wait until the 2567 is received to begin to address the deficiencies.
Collect Temporary IDs
If the hospital has issued temporary IDs to the surveyors, they should be collected at the end
of the exit conference.
F. How to Handle Unusual Problems with Surveyors
Surveyors, like hospital personnel, have different styles and personalities. Some are more
competent/experienced than others, and some are more pleasant than others. This is to be
expected. All surveyors should be treated courteously and respectfully. This type of treatment
will accrue to the hospital’s benefit. Remember, the surveyors are just doing their job. They
and the hospital have the same goal: assuring safe, high-quality patient care.
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Surveyors should also treat hospital personnel courteously and respectfully, and behave
professionally. They are expected to follow infection control protocols, respect patient privacy,
and dress and behave appropriately.
CDPH employs more than 600 surveyors as well as consultants, management and support
staff. Conflicts and misunderstandings can occur with any human interaction. In addition,
like any large employer, occasionally CDPH will have a problem employee. If a hospital has
a serious issue with a CDPH employee, it must be handled professionally and confidentially.
Obviously, safe patient care is paramount and must take precedence over upsetting or
angering a surveyor.
In the rare case in which a surveyor behaves inappropriately, the hospital should document
the facts (not conclusions). For example, if a surveyor appears intoxicated on the premises
of the hospital, the hospital should have the employee or employees who observed the
surveyor document that “surveyor X slurred her words, stumbled, and smelled of alcohol,”
not “surveyor X appeared drunk.” Document quotes as appropriate, as well as the names
of any witnesses. If possible, the CDPH survey team leader should be called to observe the
allegedly inappropriate surveyor. If it is necessary to remove the surveyor from a patient care
area, do so tactfully — for example, ask to meet with the surveyor in a private conference
room. The hospital should have two trusted employees interact with the surveyor, so there is
a witness.
A hospital executive should explain the situation factually to the on-site CDPH survey team
leader as soon as possible. If that person does not resolve the problem (or is part of the
problem), the hospital executive should call the appropriate supervisor in the CDPH district
office; if that doesn’t work, then escalate to a district administrator or the district manager. In
some cases, the hospital may need to involve CDPH executive management in Sacramento.
If the surveyor is conducting a CMS survey, CMS may be contacted — CMS has indicated to
CHA staff that it wishes to be informed of significant problems with surveyors.
Occasionally, a hospital will have a problem with a surveyor that isn’t as urgent as indicated
above, but still needs to be resolved. An example might include a surveyor who seems to
have a biased attitude against the hospital, or is somewhat threatening, hostile or insulting.
The hospital may wish to have a high-level employee who has excellent “people skills” meet
with the surveyor privately to review the documented facts, and devise a solution together.
If this approach does not resolve the issue, the hospital may then involve the district office
supervisor, CDPH executive management and/or CMS.
Situations with surveyors may evolve over time. The hospital should document any unusual
or negative incident that occurs with a surveyor, in case this documentation is later needed to
demonstrate a pattern of behavior.
Many hospitals fear retaliation from surveyors if they question/challenge the surveyors
or bring issues to the attention of the surveyors’ supervisors. This is an understandable
concern. CHA staff has worked closely with CDPH executive management in Sacramento,
and knows that CDPH leadership is genuinely interested in learning about inappropriate
behavior on the part of surveyors so that they can correct it and improve the survey process.
Just as a hospital would want to know if one of its employees is not representing the hospital
well, CDPH wants to know about its personnel. It is difficult for CDPH leadership to act
upon complaints about surveyors when the hospital involved declines to be identified or
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to identify the particular surveyor involved. CDPH has been clear that it does not tolerate
retaliation. CDPH can — and has — reassigned surveyors who behave inappropriately or act
in a retaliatory fashion. Nevertheless, it is not possible for CHA to completely alleviate this
understandable concern.
5 After the Survey: Preparing
the Plan of Correction
Chapter 5 — Contents
©CALIFORNIA HOSPITAL ASSOCIATION
I. Communicating Survey Results ....................................................................... 5.1
A. Governing Body ........................................................................................... 5.1
B. Employees .................................................................................................... 5.2
C. Medical Staff ................................................................................................ 5.2
D. News Media .................................................................................................. 5.3
II. Initial Steps .......................................................................................................... 5.4
A. Begin Immediately After the Exit Conference; Deadlines .......................... 5.4
B. Debrief Staff ................................................................................................. 5.4
C. Transcribe the Recording of the Exit Conference ...................................... 5.4
D. Convene the Response Team ...................................................................... 5.5
E. Consider Involving Legal Counsel and/or Consultants .............................. 5.5
F. Submitting Information After the Exit Conference ...................................... 5.6
III. Develop Preliminary Corrective Action Steps .................................................. 5.6
IV. Drafting the Hospital’s Final 2567 Response and PoC .................................... 5.7
A. Reconvene the Response Team Upon Receipt of 2567 ............................. 5.7
B. Questions ..................................................................................................... 5.8
C. Turn the Preliminary Corrective Action Steps into the 2567 Response ..... 5.8
D. Drafting the Hospital’s 2567 Response ....................................................... 5.9
Complete Response Needed for Each Deficiency ......................................... 5.10
Remember That the Response Will be Publicly Available ............................... 5.10
Include All Actions — Even the Obvious Ones............................................... 5.10
Describe New or Revised Policies ................................................................. 5.10
Consider Whether to Attach Documents ....................................................... 5.11
Be Cautious in Disclosing Disciplinary Action ................................................ 5.11
Describe Staff Education and Training ........................................................... 5.12
Describe Monitoring ...................................................................................... 5.12
Date of Corrective Action .............................................................................. 5.13
E. Hospital Disputes Factual Findings in 2567 .............................................. 5.13
F. Cover Letter Accompanying Hospital’s Response .................................... 5.14
V. After the 2567 Response is Submitted ........................................................... 5.15
A. Documentation ........................................................................................... 5.15
B. Continuous Improvement .......................................................................... 5.16
C. Hospital Forgets to Include Something in the PoC .................................. 5.16
D. Follow-Up Questions from Surveyors ....................................................... 5.16
E. Final Actions by Surveyors ........................................................................ 5.17
5 After the Survey: Preparing
the Plan of Correction
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Once the exit conference is over and the surveyors have left the facility, there is still plenty of
work to do. The hospital must respond to questions about the survey, communicate survey
results, and develop preliminary corrective action steps. After the Statement of Deficiencies
(the CMS or State 2567) is received, the hospital must prepare and submit its plan of
correction, and possibly appeal any adverse actions. This chapter focuses on these tasks.
I. COMMUNICATING SURVEY RESULTS
A. Governing Body
The survey results should be promptly communicated to the chair of the hospital’s governing
body/board. Together, the chair and the hospital CEO should determine how much and how
soon additional communication to the full governing body may be needed. While there may
be an inclination to spare the governing body specific details, and a reluctance to involve
them in specific remedial actions, it is important to keep in mind their overall responsibility for
the hospital, and that they may receive inquiries from a variety of sources (inside or outside
the hospital). They will not want to be caught off guard. The Centers for Medicare & Medicaid
Services (CMS) and the California Department of Public Health (CDPH) expect the governing
body to be aware of survey results and to take them seriously.
Moreover, in some cases — and especially where the Governing Body Condition of
Participation (CoP) is or may be involved — early and proactive governing body participation
may be called for. Key factors to look at are:
1. If the Governing Body CoP, or any related standards, are cited as out of
compliance, then the governing body must be made aware of these right away. In
this circumstance, the governing body will likely need to demonstrate improvement
in its oversight functions in order for the hospital to come back into compliance with
the condition or standard(s).
2. Consider the need for a governing body task force, or at least a delegation
of authority to a group or committee as may be needed to effectuate prompt
corrective actions.
3. If the survey findings suggest that many policies and procedures will need to be
revised and have governing body approval, the governing body may need to be
put on-call to be available, when needed, to approve these revisions. (Check the
meeting notice requirements of the hospital’s corporate bylaws.) The hospital may
wish to consider whether the governing body should be asked to delegate approval
authority to key individuals. If there is a delegation of authority, there still needs to
be ultimate accountability to the governing body. However, most actions can be
implemented upon approval by the authorized representative(s), and later ratified by
the governing body.
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B. Employees
Hospital leadership may wish to communicate to employees the results of the survey; its
potential implications for ongoing licensure, certification or accreditation; and the importance
of prompt and effective corrective action. However, if negative findings are anticipated, the
hospital should take care not to create an atmosphere of alarm or confusion. Moreover,
the hospital should expect that anything said in open staff forums or written in memos
may ultimately make its way into the media and/or other venues. Thus, how and when the
survey results are communicated are crucial to getting the staff on board with accepting and
effectuating any significant changes that may need to be made in a short period of time.
The initial focus should be on pulling together as a team to correct any deficiencies. Avoid
blame, which can undermine morale and interfere with the compliance process.
Staff meetings may be held to acknowledge the survey and the apparent negative results
(based on the exit conference), if there are any. The level of detail communicated will depend
upon the scope of the problems (if any) as well as the particular forum.
If many areas of the hospital’s operations have been found deficient, general staff meetings
may be needed to communicate what is happening, answer questions and quash rumors.
Avoid specifics for these meetings, as confidentiality issues may be at play, while addressing
the general areas that require improvement and what the general process will be. Focus
these discussions on how improvements will benefit hospital operations and patient care.
Encourage employees to ask their managers if they have any questions, but to be
circumspect in speculating and discussing possible survey results unnecessarily.
Additional staff meetings will likely be necessary to “drill down” to the individuals whose
actions and cooperation will be needed to effectuate corrections. For these meetings:
1. Be straightforward about areas of deficiencies (although confidentiality as to specific
details may still be important).
2. Give the staff an idea of what the process will be (plans of correction, new policies
and procedures, more surveys, etc.).
3. Try to develop an “ownership” mentality, emphasizing the importance of staff
cooperation and active participation. This is an important step to effectuate change.
Encourage the staff to be part of the solution by letting them know that as new
draft policies and procedures are produced, their feedback and comments are a
necessary part of the improvement process.
C. Medical Staff
If the deficiencies involve issues within the purview of the medical staff, the hospital should
promptly notify the chief medical officer and the chief of the medical staff. Early convening
of the Medical Executive Committee may also be needed. Key leadership should have
been previously educated regarding maintaining compliance with licensing, certification
and accreditation requirements, as well as the survey process (including how to work
with surveyors). Similarly, if deficiencies involve issues within the purview of medical staff
committee(s) or department(s), the committee or department chair(s) should be informed
and meetings convened as early as possible. Each affected committee or department should
consider whether delegation of immediate action authority to one or more representatives will
be necessary to facilitate prompt corrective action.
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The medical staff response to the survey is one of the more difficult issues to manage, and
hence is an area where leadership is key. Early mobilization of key staff leaders is critical to
effective corrective actions. While it is generally true that the corrective measures will involve
policy and procedure changes and other generic changes to medical staff operations, it
is sometimes true that remedial action may require practitioner-specific corrective action
pursuant to the medical staff bylaws.
Issues within the medical staff purview cannot be resolved by hospital administration alone.
It is important early on to evaluate what is really at issue, and to work with the medical
staff leadership to identify specific actions that effectively address and resolve the identified
problems(s).
D. News Media
The hospital should have policies and procedures in place for handling all requests
for information from the news media. Typically, either someone in the hospital’s public
relations department or hospital administration is designated as the hospital’s official media
spokesperson.
The hospital should anticipate that the news media will likely learn of the survey results. This
is especially true if an immediate jeopardy (IJ) has been declared or a fine will be assessed.
The hospital spokesperson should be informed of the survey results at the same time that
key hospital leadership is provided the information. This affords the spokesperson the best
opportunity to develop appropriate messages in a timely manner, and to be prepared to
respond to media inquiries. Depending on the specific results, consideration should be given
as to whether a senior executive with clinical expertise (Chief Nursing Officer, Chief Medical
Officer, etc.) should participate in media interviews. This may help to diffuse concerns about
the impact of any identified deficiencies on the quality of care provided to patients.
It is recommended that the hospital spokesperson develop a comprehensive set of Talking
Points to use in response to media inquiries. The tone of the Talking Points should be
straightforward and honest, without assigning blame to anyone involved. Nor should the
Talking Points seek to discredit the surveyors. If the hospital disagrees with the survey results,
a matter-of-fact statement to that effect — and why — may be appropriate.
If the media learn of the survey results prior to the hospital being able to fully analyze and
investigate the information, a comment such as the following should be made. “We are
still investigating these issues to more fully understand the surveyors’ concerns. We are
committed to ensuring the delivery of high quality, safe patient care.”
Should the media inquiry come as the result of a publicly announced IJ or administrative
penalty, it is recommended that the hospital be as forthcoming as possible without putting
itself in any legal jeopardy. Straightforward answers that acknowledge the incident, discuss
what corrections/changes the hospital has made to correct the issue, and reconfirm the
hospital’s commitment to the delivery of safe patient care will provide the hospital with the
best opportunity to regain the public’s trust.
(See D.“Public Availability of CMS-2567,” page3.32, D.“Public Availability of CMS-2567,”
page3.32 and C.“Public Notice,” page3.36, regarding the information CDPH and CMS will
make available to the public.)
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II. INITIAL STEPS
A. Begin Immediately After the Exit Conference; Deadlines
Once the surveyors have left the facility, there may be an inclination to wait for CMS’s or
CDPH’s next move — i.e., to await the written survey results and see what they “really
meant” by their exit comments. That would be a mistake. As mentioned earlier, the surveyors
are supposed to discuss all findings during the exit conference. Thus, the hospital should
(but may not always) know of every deficiency that could be cited in the final CMS-2567 or
State-2567 report, and should begin taking action immediately. Keep in mind that in some
instances the hospital may not even receive the 2567 report for a month or two after the
survey. The hospital cannot sit back and wait to take corrective action steps until that time.
The hospital should begin work on its corrective action steps immediately after the exit
conference — if not before. Those corrective actions that can be taken during the survey,
while the surveyors are still on-site, should be taken.
Keep in mind, too, that all of the hospital’s deadlines regarding federal surveys are based on
calendar days, rather than working days (although deadlines that apply to CDPH and CMS
are usually based on working days). Thus, the hospital’s clock starts ticking the day of the
exit conference — very often a Friday — and the ticking does not lapse for weekends or
holidays.
Hospitals may wish to be cautious, however, about taking corrective action steps that require
a large expenditure prior to receiving the 2567. Hospitals may wish, instead, to make as
many preparations as possible, but not legally commit to the expenditure until receipt of
the 2567. It is possible that the surveyors will decide, after the exit conference, not to put
a particular deficiency on the 2567 after all, even though it was discussed during the exit
conference.
B. Debrief Staff
After the exit conference (or, better yet, each day after surveyors have left), interview escorts
and any staff that interacted with surveyors to determine what was actually said. This may
help clarify complicated fact-specific issues and may also help identify any factual errors
or misunderstandings by surveyors. These interviews may also reveal opportunities to
educate staff to improve responses to surveyors. Keep in mind that it is unlawful to retaliate
against patients, employees, members of the medical staff, or other health care workers for
cooperating with CDPH or CMS surveyors [Health and Safety Code Section 1278.5].
C. Transcribe the Recording of the Exit Conference
The exit conference is the hospital’s primary source of initial direction regarding preparation
of the plan of correction. If the conference was recorded, the written transcription of the
actual comments made by the surveyors at the exit conference (rather than each participant’s
notes of what they think they heard) may be a useful tool in guiding the development
and implementation of the PoC. The transcript should be prepared and distributed to the
response team as soon as possible.
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D. Convene the Response Team
To develop a satisfactory PoC within the required time frames, the hospital should assemble
a team immediately following the exit conference to dissect what occurred, why it occurred,
what will be done to correct the occurrence, what will be done to prevent recurrence, and
to implement the measures developed. Coordinate the matters raised in the exit conference
with the notes key leaders made during the survey. Where there are particular records
involved, carefully review the applicable records to identify any surveyor errors or missing
information that might change the findings.
The composition of the response team will depend upon the deficiencies identified by
the surveyors. For example, if many of the deficiencies are related to pharmacy, then
the hospital’s pharmacist in charge should be part of the response team. Likewise, if
nurse education was an issue, the hospital should include representatives from nursing
administration, staff training and education, or other appropriate areas of the hospital. If the
hospital has an in-house legal department, in-house counsel should be included as part of
the response team.
E. Consider Involving Legal Counsel and/or Consultants
If it appears that the outcome of a survey could result in termination of participation in the
Medicare and Medicaid programs, a hospital should immediately consider involving a health
care attorney experienced in assisting hospitals with licensing and certification issues. Ideally,
counsel should be involved immediately after the exit conference or during the survey if an
IJ is identified. The primary role of counsel is to review the documents with an eye to the
specific CoPs, standards, tags, Interpretive Guidelines and other statutes and regulations
involved. Counsel can also advise on the best way to develop the plan of correction,
especially when full compliance cannot be achieved immediately, such as when equipment
purchases, construction or major education efforts are required. In addition, having an
attorney involved in the development of the hospital’s response allows much of the work
product to be protected by the attorney-client privilege.
In certain cases, especially where the hospital’s staff may not have the requisite expertise
or experience, it may be advisable to involve consultants. This is especially the case where
complex processes are involved or the competence of the current director of a function
is at issue. Examples of a complex process may include a need to reorganize the medical
records function or respond to highly technical laboratory deficiencies. Consultants need to
be selected carefully, but quickly, in accordance with the applicable deadlines for the 2567
response. Counsel may have worked with consultants in prior cases and may be helpful in
identifying and contracting with them.
When outside consultants are used, confidentiality of the information the consultants obtain
is always an issue. If individually-identifiable protected health information will be shared with
outside legal counsel or with consultants, a business associate agreement that complies
with the Health Insurance Portability and Accountability Act regulations will be required. (See
CHA’s California Health Information Privacy Manual for more information.)
It is advisable to structure the consulting engagement to make the consultants a part of
the hospital’s medical staff quality assurance system to take maximum advantage of state
confidentiality laws relating to peer review and/or medical staff quality assurance. Counsel
can be helpful with these agreements. Consideration should also be given to whether
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consultants should be engaged by and report to counsel in order to take advantage of the
attorney work product privilege.
When consultants are involved, counsel can help assess whether it would be helpful to
disclose their participation to CMS and/or CDPH. If CMS or CDPH is familiar with, and
has confidence in, the particular consultants, this may improve the prospects for a finding
of a credible allegation of compliance at a stage before the consultation process is fully
completed.
If a consultant is a former surveyor, there may be conflict of interest or other legal prohibition
that should be explored before the consultant is engaged. The consultant should certify that
he/she knows of such conflicts or prohibitions. Hospitals should be aware that The Joint
Commission does not permit its surveyors to act as consultants.
F. Submitting Information After the Exit Conference
A question that occasionally arises is whether the hospital may submit additional information
to CMS or CDPH for consideration after the exit conference but before the CMS- 2567 or
State-2567 is prepared by the surveyors or received by the hospital. Unfortunately, there is no
formal avenue for doing this. However, if the hospital has additional information that was not
originally available to the surveyors, but that might avert a final determination of a deficiency,
the hospital should try to get that information to the surveyors as quickly as possible.
Similarly, the hospital should try to get information to the surveyors regarding significant errors
before the 2567 report is issued.
III. DEVELOP PRELIMINARY CORRECTIVE ACTION STEPS
The hospital should develop preliminary corrective action steps based on the deficiencies
noted during the survey and the exit conference. The response team should review each
deficiency identified by the surveyors. If the survey was a CMS survey, the team should
review the Medicare CoP that is implicated, its component standards, and the associated
Interpretive Guidelines (see III.“Which Laws are Federal Surveyors Assessing Compliance
With?,” page3.3). This review will help the response team identify what the hospital needs
to do to correct the deficiency and become compliant with the conditions and standards. The
team should keep in mind that one deficiency may implicate more than one CoP. It may be
especially difficult for the response team to guess when the “Governing Body” and “Medical
Staff” conditions may be implicated by a deficiency. Nevertheless, an early review of the
conditions and standards will guide the hospital in developing its preliminary corrective action
steps.
If the survey was a state survey, the team should review the Title 22 or Health and Safety
Code provisions that may be implicated (see III.“Which Laws are State Surveyors Assessing
Compliance With?,” page2.6).
The hospital may have to make some educated guesses regarding how the surveyors will use
each deficiency to support noncompliance with which standard and/or condition (for CMS
surveys) or which Title 22 or Health and Safety Code provision (for state surveys).
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Once the team has identified to its best ability what needs to be done to correct each
deficiency, a written document should be produced. The document should list:
1. Each action step, including any new policies and procedures needed, revisions to
existing policies and procedures, and training needed.
2. The hospital employee(s) responsible for implementing the step.
3. The deadline for implementation.
4. How the fact of completed implementation will be communicated back to the team
leader.
Potential corrective action steps include development or revision of policies and procedures
and forms; peer review activities; performance improvement projects; and staff education.
The hospital should also develop an auditing or monitoring plan to ensure that new policies
or procedures are followed after they are put in place. The hospital may wish to monitor
more frequently when new policies and procedures are first implemented, and reduce the
frequency as the new policies and procedures become routine. In addition, the efficacy of the
action steps should be evaluated, and changes made as appropriate.
The team leader should follow up regarding implementation of action steps and schedule
team meetings as necessary to keep everyone on track.
The hospital should keep detailed notes of all its corrective action steps (including minutes of
meetings) so that, once the final 2567 report is received, the hospital has documentation of
its progress since the survey.
IV. DRAFTING THE HOSPITAL’S FINAL 2567 RESPONSE AND POC
A. Reconvene the Response Team Upon Receipt of 2567
Upon receiving the 2567 report, the hospital should make multiple copies for the response
team, and set aside the original for use in producing the final response. The team leader
should quickly review the 2567 report with an eye toward determining whether any additional
members will need to be added to the response team. The response team should be
convened as soon as possible.
The team should read and analyze the full 2567 report. For each finding, the team should
determine whether:
1. The finding is new and needs to be addressed for the first time,
2. The finding has already been fully addressed by the hospital’s preliminary corrective
action steps, or
3. The finding has been addressed in the preliminary corrective action plan, but the
plan needs modification or further action.
The 2567 report will list the conditions and standards (if a CMS survey) or the Title 22 and
Health and Safety Code provisions (if a state survey) implicated. The team should review any
of these that were not reviewed in developing the preliminary corrective action steps.
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The response team should also review the cover letter that accompanies the 2567 report.
The hospital’s response must specifically address each category listed in the cover letter (see
B.“Cover Letter From CMS Accompanying CMS-2567,” page3.31).
B. Questions
The team should gather all of the questions it has and determine how to approach each
one. Strategize the pros and cons of calling CMS and/or CDPH, other hospitals, CHA,
and/or outside consultants. If the team decides to seek clarification from CMS or CDPH,
formulate the questions to assure you get clear answers. If the response is not clear, ask
for clarification. Respect the chain of authority, but if it is not working properly, escalate the
matter politely. Identify who the hospital should work with in the future if additional questions
arise.
C. Turn the Preliminary Corrective Action Steps into the 2567 Response
After receipt of the 2567, the hospital will want to turn the preliminary corrective action steps
into the final 2567 response. The preliminary corrective action steps usually comprise an
immediate-response plan that is not tailored to the 2567 report completed by the surveyors
(because the corrective action steps are developed before the 2567 is received). The
preliminary corrective action steps may be used as a resource for drafting the final 2567
response, but the pertinent information may need to be reorganized and augmented to show
how the hospital’s actions have addressed the specific findings cited by the surveyors. It is
important to follow the exact order of the findings in the 2567 report, and to respond to each
and every finding.
The response team should not become wedded to its preliminary corrective action steps.
Sometimes there is a tendency to want to simply restate the corrective action steps rather
than to isolate the specific issue involved in each finding, as well as the specific corrective
measures that address the specific issue.
Once the 2567 report is received, the response team needs to approach the issues
differently. This is because the surveyors take general factual findings (which they reported to
the hospital in the exit conference) and they “unbundle” them into many different conclusions.
A single fact may be used to support a conclusion that the hospital is out of compliance with
a whole series of standards within a condition, as well as a conclusion that the hospital is out
of compliance with more than one condition (or, if a state survey, more than one Title 22 or
Health and Safety Code requirement). Thus, even though the surveyors may repeat a certain
fact throughout their 2567 report, the gist of the conclusion will shift slightly from standard to
standard, and significantly from condition to condition. The hospital’s response must likewise
be tailored to address the specific standard and/or condition (or Title 22 and/or Health and
Safety Code requirement) at issue.
In addition, despite the fact that the surveyors are supposed to have reported all findings
during the exit conference, there may be new findings the hospital has never heard of, or the
2567 report may exclude some findings the team was expecting to see and was prepared to
respond to, and/or the report may present expected findings but with facts that are slightly
different than anticipated. The hospital must respond to, and only to, the findings in the 2567
report.
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The hospital should do the following:
1. If there is a new issue presented, develop corrective action steps immediately.
2. If there are findings described during the exit conference that are not included in the
2567, all references to corrective actions taken regarding them should be excluded
from the final 2567 response/PoC.
3. If the findings contain some surprises or different facts, adjust the hospital’s 2567
response accordingly. Forget the old facts that were originally anticipated when
developing the corrective action steps.
4. Rebundle the information from the initial corrective actions as necessary to
address each finding within the context of the specific standard, condition or state
requirement. Augment with any needed additional information or corrective actions.
The final PoC will include immediate measures taken to address the specific problems cited,
as well as such structural and process measures that may be necessary to achieve long-term
correction and prevent recurrence.
D. Drafting the Hospital’s 2567 Response
The hospital is required to prepare and submit a PoC — that is, the steps the hospital has
already taken and/or will take to correct the deficiencies noted in the 2567 and prevent
future violations. For federal surveys (the CMS-2567), the PoC must be sent to the State
Survey Agency (CDPH) within 10 calendar days after the hospital receives the statement
of deficiencies. (See VI.“The Form CMS-2567: Statement of Deficiencies and Plan of
Correction,” page3.30, regarding state time frames.) The hospital may complete the two
right-hand columns of the 2567 form itself, or attach a separate document.
While column four is called “Provider’s Plan of Correction,” the actual response required
for this column may be a plan of correction (meaning the steps the hospital has already
taken and the steps the hospital will take after the 2567 response is submitted to achieve
compliance) or, using a CMS term, a “credible allegation of compliance” (meaning that the
hospital has completed all steps it believes necessary to achieve compliance when the 2567
response is submitted).
The CMS State Operations Manual requires a PoC to include the position of the person who
will monitor the corrective action and the frequency of monitoring, as well as the dates each
corrective action has been or will be completed.
Hospitals should not use individuals’ names — either employees, patients, medical staff
members, or others — on the PoC. If the surveyors have used an identifier to refer to an
individual, the hospital should use the same identifier to refer to that individual in its response.
If the hospital wishes to refer to individuals not identified by the surveyors, the hospital
may refer to employees by their position, discipline, or job title or be assigned an identifier.
Patients, family, surveyors and others should be assigned an identifier of some type.
The hospital should indicate how the hospital’s governing body and executive management
— including the board of directors/trustees — and the quality assurance and performance
improvement functions are engaged in the corrective action plan.
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The CEO or other appropriate individual must sign and date the 2567 before returning it to
the State Survey Agency (CDPH). It must meet the approval of the State Survey Agency for it
to be acceptable.
Complete Response Needed for Each Deficiency
Every response to a deficiency should stand on its own. The entire answer, complete with all
the detail, must be in the hospital’s response to each deficiency. This requirement can result
in a lot of repetition. However, this is important because the hospital’s 2567 response may
be broken up among the surveyors for review, making cross-references difficult for them to
evaluate.
The goal of the hospital’s 2567 response is to include enough detail about the corrective
action steps so that a reader unfamiliar with the hospital (and who is not a clinician) can
envision the “fix” — the actions taken and how these steps will prevent recurrence.
Remember That the Response Will be Publicly Available
Keep in mind that the hospital’s 2567 response will be publicly available. The hospital will
want to minimize adverse publicity, clarify misperceptions, and generally reassure the public
about the facility. Care must be taken not to offend the surveyors (there is significant agency
discretion in accepting the PoC), yet not to permit incorrect or unwarranted conclusions to go
unanswered.
Include All Actions — Even the Obvious Ones
Think of the most obvious fix to a problem. Include this action. Then describe other action
steps taken.
Illustration:
Finding on 2567: “The light fixture in Linen Closet X was burned out.”
Incomplete response: “On [date], the hospital’s policy and procedure regarding how
often light bulbs should be checked was amended.”
Preferable response: “The burned-out light fixture in Closet X was immediately
replaced on [date – the date of the survey]. The hospital’s policy and procedure
regarding how often light bulbs should be checked was amended on [date] to
require [daily or weekly] checking and documentation of [daily or weekly] checking.
A sign was placed in all linen closets informing staff to call Environmental Services at
extension XXXX upon finding a burned-out light bulb.”
Describe New or Revised Policies
Provide detailed descriptions of new or revised policies and procedures, rather than just
stating that “a new policy and procedure regarding XXX was developed” or “the policy and
procedure regarding XXX was revised.” If the relevant language of a revised policy is short, it
may be good to quote that language. It is not enough to simply attach the new/revised policy
and let the surveyors find the “fix.” If you do attach a policy (in addition to including a specific
description of what is new or different in the policy), highlight the relevant portions. (See the
illustration above, which states that the policy was amended “to require [daily or weekly]
checking and documentation of [daily or weekly] checking.”)
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Consider Whether to Attach Documents
Consider carefully whether to attach documents, such as policies and procedures, to the
hospital’s 2567 response. Surveyors differ in their view of whether documents should be
attached. Some surveyors do not accept attachments, while others will request additional
documents (such as revised policies and procedures) if they are not attached to the 2567.
Even if the hospital includes attachments, the hospital must make sure that the plan of
correction can stand on its own (as if there were no attachments). The 2567 response must
be drafted with this requirement in mind. CMS has told CHA staff that CMS will review
attachments, but will later discard them. If CMS subsequently accesses its copy of the
hospital’s plan of correction for some reason, the attachments will not be available.
When determining whether to submit attachments to the 2567, the hospital should consider
that, if documents are attached, the surveyors may take the opportunity to scrutinize them
and find other deficiencies. In addition, the documents may be made publicly available — the
hospital may or may not have an issue with this. Finally, if the documents are attached, the
surveyors may not feel it necessary to do a resurvey. This may deprive the hospital of the
opportunity to make a good appearance at the resurvey. On the other hand, if the surveyors
do a resurvey, they may find new deficiencies.
If documents are attached to the 2567, the attachments should be clearly marked so the
surveyors can easily identify which responses they relate to. If documents are not attached,
the hospital should note in its cover letter or in the PoC that copies are available upon
request.
Be Cautious in Disclosing Disciplinary Action
The hospital should consult legal counsel before disclosing on a 2567 response specific
details of disciplinary actions taken against employees or medical staff members, as this
document may be publicly available. If legal counsel cautions against such disclosure, it may
be sufficient to put some version of the following language in the 2567 response:
“The hospital carefully reviewed and documented its review of any allegations made as to
employees and/or medical staff members to determine whether any disciplinary or corrective
action was warranted. These reviews were completed as to employees on [date] and as to
members of the medical staff on [date].
Employee matters are reviewed under the policies and procedures of the Human Resources
Department (approved on [date] by the Board of Trustees/Directors). These include a system
of progressive disciplinary actions for which the Vice President of Human Resources is
ultimately responsible. Complete records of any such actions taken during the period from
[date] to [date] are maintained and are available for on-site inspection in the office of the
Director of Human Resources.
Medical staff matters are reviewed by the medical staff department and service chiefs and
applicable committees under the direction of the Chief of Staff. Any actions are ultimately
subject to approval or disapproval by the Board of Trustees/Directors, which has overall
responsibility for the quality of care rendered in the institution. The medical staff has bylaws,
rules and regulations that deal with peer review and corrective action as to medical staff
members (approved by the medical staff on [date] and by the Board of Trustees/Directors on
[date]). Complete records detailing any corrective actions that took place during the period
from [date] to [date] are maintained and are available for on-site inspection in the office of
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the Medical Staff Coordinator. The Board of Trustees/Directors is subject to the procedures
specified in the documents listed above, and is also bound by its own bylaws (approved by
the Board of Trustees/Directors on [date]). Complete records detailing any corrective actions
undertaken by the Board of Trustees/Directors are maintained and are available for inspection
in the hospital’s administrative offices.”
If legal counsel approves the disclosure of disciplinary action, the hospital should describe
all levels. For example, if a nurse is first verbally counseled for failing to record vital signs, but
later he or she is given a written counseling and required training, all three actions should be
detailed, including the dates. The identifier used by the surveyors should be used, not the
employee’s name.
Describe Staff Education and Training
When the response calls for staff education and training, include all types of education,
whether individualized or group, whether the education is written or oral, etc. Be clear in
describing which staff will be trained (for example, “all RNs working in the neonatal ICU”). Do
not say “all staff” unless you really mean that. Include all dates that the education occurs, not
just the first or last date. CDPH requires that all staff development programs be documented
by:
1. A record of the title, length of course in hours, and objectives of the education
program presented;
2. Name, title, and qualifications of the instructor or the title and type of other
educational media;
3. A description of the content;
4. A date, a record of the instructor, process, or media and a list of attendees; and
5. Written evaluation of the course content by attendees.
[Title 22, California Code of Regulations, Section 70214(d)]
You may wish to note in the 2567 Plan of Correction that these records are available.
Describe Monitoring
The hospital must describe the monitoring it will undertake — that is, what review, quality
assurance measures, monitoring procedures, etc. are being done so that the particular
deficiencies cited in the 2567 do not and cannot happen again. The 2567 response should
describe who is responsible for monitoring (title of person), how often they monitor, what they
monitor for, who the results are reported to, what happens with the results (whether good or
bad), and what procedures are in place to alert key personnel if a problem occurs again so
it can be corrected right away. The monitoring should be integrated into the hospital’s larger
QAPI processes.
Tiered monitoring may be warranted if serious patient care issues are at stake. The first
layer of monitoring may be intense and aggressive — perhaps hourly or daily review. After
improvement is seen, monitoring can drop to less frequent review — perhaps weekly. When
ongoing compliance has been achieved, monitoring can return to part of the general audit
process.
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Review the 2567 to determine whether it specifies which person is responsible for the task
that was deficient (for example, “The Director of Nursing is responsible for….”). If so, the
person responsible for monitoring must be that designated individual.
Date of Corrective Action
The 2567 contains a column where the hospital is required to put a date by which each
deficiency is fixed. Only one date should be included, across from the first line of each
deficiency. (If a separate document is used for the PoC, it too should contain one final
completion date per deficiency.) The date used should be the latest date when all of the
collective actions that formed the response were completed. For CMS-2567 forms, this date
should be within 30 days of the exit conference, or (with rare exceptions described below)
no later than the date the 2567 response is due. Interim dates should be embedded in the
explanation of the action items.
The rare exceptions apply to actions, such as plant and equipment changes, that cannot
be completed until a later date. When that occurs, it is necessary to fully describe concrete
steps already completed, such as starting construction, submitting design plans, or ordering
equipment. It may be possible to use the date that the hospital undertook this action as the
completion date. However, this must be accompanied by an explanatory note stating when
final completion is expected.
If the Medical Executive Committee or Board of Trustees/Directors has not yet approved
a policy and procedure, and this cannot be accomplished before the 2567 response is
submitted, the hospital should consider stating: “These policy changes were immediately
implemented and approved by the Department of Nursing on [date]. They are scheduled
for action by the MEC during its next scheduled meeting on [date] and by the Board of
Trustees/Directors during its next schedule meeting on [date].” It is preferable, however, to
have these bodies meet emergently and approve the policies.
If a training program will run for a number of days or weeks, state which dates occurred prior
to the due date of the 2567 response, and then state something along the lines of “training
will continue on 4/10-4/15 in order to achieve 100% attendance by all trauma nurses.” Be
sure to make provisions to train staff on vacation or otherwise absent during the regular
training.
E. Hospital Disputes Factual Findings in 2567
There is no formal procedure for appealing a factual error reflected in a 2567. A hospital that
disagrees with a factual finding regarding a cited deficiency has several options:
1. Accept the deficiencies cited and submit a response to the 2567.
2. Document objections to the cited deficiencies, submit a response to the 2567, and
provide convincing arguments and evidence that the findings are incorrect.
3. Document objections to the cited deficiencies and provide convincing arguments
and evidence that the findings are incorrect. Submit this information to CDPH or
CMS in the form of a letter rather than as a response to the 2567.
Which option to select will depend upon the facts and circumstances. Hospitals are
encouraged to work with their local district office staff to discuss the perceived error and
determine how best to address it. Hospitals may also wish to consult experienced legal
counsel.
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©CALIFORNIA HOSPITAL ASSOCIATION
Option two provides two benefits that hospitals may wish to consider:
1. The hospital’s position will be made public whenever the 2567 is released, and
2. The information will be included in the documentation considered during any
subsequent reconsideration and hearings.
The hospital choosing option two should document its position in the PoC, and clearly
specify why the finding of a deficiency is incorrect or inaccurate. The hospital should also
provide necessary clarification or supporting information. When drafting the response, be
clear that the hospital is challenging the accuracy of the factual findings that underlie the
alleged deficiency, not challenging the legal conclusion that the facts warrant the finding of a
deficiency.
Illustrations:
If the surveyor erroneously reported a crack in the meat slicer, the hospital’s 2567
response should courteously correct the facts: “The cracked plastic part mentioned
in the findings was on the puree blender, not the meat slicer. The cracked part was
replaced on [date]. The hospital’s policy and documentation forms regarding food
preparation equipment inspection were revised on [date] to require [daily or weekly]
inspection and documentation of [daily or weekly] inspections of all puree blender
parts.”
If the surveyor erroneously states that the hospital failed to document a new order
on a follow-up form and the hospital can produce evidence that this finding is
incorrect, the hospital should attach evidence and then state in the 2567 response:
“Hospital disputes the finding that it failed to document the new antibiotic order on
the ED follow-up form. There is documentation on the follow-up form that the new
antibiotic was ordered and called in to the patient’s pharmacy. The patient was
notified on [date] at [time]. See Exhibit A.”
It is important to note that the presence of an error in the 2567 does not extend the time line
for the hospital’s submission of its response and plan of correction. (See CHA’s EMTALA:
A Guide to Patient Anti-Dumping Laws for more information regarding disputing EMTALA-
related deficiencies.)
F. Cover Letter Accompanying Hospital’s Response
The CEO or designee should prepare a cover letter to accompany the hospital’s response to
the CMS-2567 or State-2567. This cover letter should be used to:
1. Confirm the hospital’s understanding regarding the next steps (especially if this has
been unclear).
2. Capture, in writing, any intentions expressed verbally by the surveyors or by CMS
during telephone calls.
3. Explain if there are any disputed findings and summarize how the hospital handled
them.
Chapter 5 — After the Survey: Preparing the Plan of Correction CHA
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©CALIFORNIA HOSPITAL ASSOCIATION
4. Explain any problems in the 2567, such as cross-references that were not accurate,
condition tags that referenced a standard not included in the 2567, references to
patients not cited elsewhere, etc.
5. Note any omissions or errors, such as missing references.
6. Request clarification regarding the process and timing of the resurvey.
A sample cover letter may be found as CHA Appendix HS-10, “Sample Cover Letter for
Hospital’s CMS-2567 Response (for a CMS survey),” at the end of this manual. This letter is
designed to be used in response to a CMS survey. If the hospital underwent a state survey,
it should be sent only to CDPH and not to CMS. Obviously, appropriate changes will need to
be made to the sample letter so that it applies accurately to the particular situation at issue. It
cannot simply be copied and used as is without thoughtful revision.
Note that the CEO must sign both the cover letter and the front page of the hospital’s 2567
response.
Given the short time frame for responding to the CMS-2567, the hospital may wish to
arrange for courier or overnight delivery. The cover letter may be marked “Hand-Delivered” or
“Delivered by Courier” or similar words as appropriate.
V. AFTER THE 2567 RESPONSE IS SUBMITTED
After the 2567 response/PoC is submitted, the hospital should undertake all necessary
actions to continue to implement the plan, maintain and monitor compliance with the plan,
and assemble documentation that the plan has been successfully implemented to show
the surveyors upon resurvey. Actually, much of this work can be done before the plan is
submitted — the sooner a deficiency is fixed after identification, the better.
The drafters of the 2567 response should do the following:
1. Communicate to the responsible people identified in the 2567 response what
they are responsible for, and help provide adequate resources to achieve these
responsibilities.
2. Complete all action items within the stated time frame.
3. Monitor compliance with the corrective actions to ensure that hospital staff
members thoroughly incorporate the new policy, procedure, method or whatever
the case may be.
A. Documentation
Assemble and maintain documentation that irrefutably demonstrates compliance with the
plan of correction. Document all monitoring and the results thereof (as well as the actions that
are being monitored). This documentation should be well-organized so that the surveyors
can quickly confirm that the hospital did what it said it would do on the 2567 response. The
surveyors should not need to go searching for the documentation referenced in the hospital’s
response.
The hospital should make multiple copies of the relevant documentation, and keep it up-
to-date when any change takes place. Where appropriate, highlight specific changes or
provisions designed to address the cited deficiencies so the surveyors can see them easily.
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©CALIFORNIA HOSPITAL ASSOCIATION
B. Continuous Improvement
The hospital should continue to make improvements. As monitoring results come back,
the hospital may need to make changes and improve the processes discussed in the 2567
response. Submitting the 2567 response to the surveyors does not preclude the hospital
from making improvements as part of its QAPI process. Depending upon the facts and
circumstances, it may be appropriate to notify the surveyors of changes in actions or
monitoring activities. While sometimes it is sufficient to wait until the surveyors return to
resurvey and then explain changes that have evolved, the risk exists that the surveyors won’t
agree with the change in direction and will cite the hospital for failing to implement the PoC
as represented. Generally speaking, any significant deviations from the activities described
in the 2567 response should be reported to CDPH and/or CMS. If this is done by phone, it
should be documented.
C. Hospital Forgets to Include Something in the PoC
During the PoC implementation and monitoring process, someone may determine that an
important element of the hospital’s 2567 response was not included. The hospital should
make a decision about whether an amended version of the response should be submitted
to CDPH and/or CMS along with a cover letter explaining the missing information. If this is
done, the hospital should make sure the date that the fix occurred is still prior to the date the
hospital’s 2567 response was due (in other words, do not use the date that the amended
version was submitted). The hospital should make sure that if the missing information affects
several deficiencies (often one deficiency will be cited under several requirements, such as
Quality or Governing Body), that all are amended as necessary.
Alternatively, the hospital may determine that an amendment is not necessary and can
instead either show the surveyors the change upon resurvey or call the surveyor. Checking
with CDPH and/or CMS may be appropriate.
D. Follow-Up Questions from Surveyors
While reviewing the hospital’s 2567 response, the surveyors may ask follow-up questions.
These questions may come by way of a telephone call or a written notice. The hospital
should try to ascertain as much information as possible about what level of detail is required
for the response, what the response should look like, when the response is due, etc. If the
inquiry is by telephone, the hospital should take excellent notes during such a call, so as to
enable full compliance with the request for further information.
It is important to take these follow-up questions very seriously. In drafting a follow-up
response, the hospital should carefully review its original 2567 response as well as the initial
findings cited in the 2567 report. This background will help determine what the surveyor
believes is missing in the response. Re-reading the requirement that the surveyors felt was
not met is especially important to make sure the follow-up question asked is appropriate
given the subject matter of the deficiency cited.
In some cases, the answer to the follow-up question may already have been addressed in
the original 2567 response, but may have been overlooked by the reviewing surveyor. If the
information was already communicated in the 2567 response, then a letter that clarifies the
answer (e.g., showing where it appears in the 2567, and perhaps restating the pertinent
information) can be effective.
Chapter 5 — After the Survey: Preparing the Plan of Correction CHA
5.17
©CALIFORNIA HOSPITAL ASSOCIATION
If the answer was not addressed in the original 2567 response, or if it appeared only in
response to a different deficiency, then the hospital may need to amend its 2567 response
and resubmit it.
E. Final Actions by Surveyors
After the Plan of Correction is submitted, CDPH/CMS will review it and may resurvey the
hospital or accept the POC without a resurvey. The hospital may be put on state monitoring.
See VII.“CDPH/CMS Actions after PoC Submitted,” page3.33, for more information about
these actions.
Index
Index
1
CALIFORNIA HOSPITAL ASSOCIATION
SYMBOLS
2567, 2.11, 3.30, 5.13
A
Accreditation, 1.4
Adverse event, 2.4, 2.5
All Facility Letters (AFLs), 2.6
American Osteopathic Association (AOA), 1.3
Attorney-client privilege, 3.19
B
Breach of privacy—SeePrivacy breach
C
California Code of Regulations, 2.6
California Department of Public Health (CDPH), 1.1, 1.3
Licensing and Certification (L&C) Program, 1.1
District offices, 2.1
Organization chart, 2.1
California Hospital Association (CHA)
Catalog of administrative penalties, 2.15
CALS—SeeConsolidated Accreditation and Licensure
Survey (CALS)
CDPH—SeeCalifornia Department of Public Health
(CDPH)
Centers for Medicare & Medicaid Services (CMS), 1.2,
3.1
Regional offices, 3.1
Certification, 1.2
Certification survey, 3.2
CHA—SeeCalifornia Hospital Association (CHA)
CMS—SeeCenters for Medicare & Medicaid Services
(CMS)
Code of Federal Regulations, 3.3, 3.30
Complaint survey, 1.4, 2.4, 3.2
Condition-level deficiency, 3.7, 3.23, 3.26
Conditions of Participation (CoPs), 1.2, 3.3
Critical access hospital, 1.2
D
Deemed status, 1.2
Deficiency, 3.23, 3.26
Departmental Appeals Board, 3.37
Det Norske Veritas Healthcare, Inc.—SeeDNV
Healthcare
DNV Healthcare, 1.3, 1.4—SeeDet Norske Veritas
Healthcare, Inc. (DNV Healthcare)
E
EHRs, 3.15, 3.20
EMTALA, 1.2, 1.4, 2.24, 3.15
Entrance conference, 3.13, 4.7
Exit conference, 3.24, 4.10
F
Frontier hospital, 1.2
G
Governing body, 5.1
H
Health and Safety Code, 2.6
Health Facilities Evaluator Nurses, 2.2
HFAP, 1.3, 1.4
I
Immediate jeopardy
Federal, 3.27
State, 2.10
Interpretive Guidelines, 3.7
Interviews, 3.18
CHA California Hospital Survey Manual 2021
2 Index
©CALIFORNIA HOSPITAL ASSOCIATION
J
Joint Commission—SeeThe Joint Commission (TJC)
L
L&C—SeeCalifornia Department of Public Health
(CDPH), Licensing and Certification (L&C) Program
Licensing, 1.1
Life safety code, 3.11
M
Media, 5.3
Medicaid, 1.2
Medi-Cal, 1.2
Medical staff, 4.4, 5.2
Medicare, 1.2
Medicare/Medicaid certification
Appeal of final determination to terminate, 3.37
MERP—SeeMedication Error Reduction Plan (MERP)
N
National Fire Prevention Association (NFPA), 3.11
P
Patient privacy rights, 3.22
Peer review, 3.19
Penalties, 2.12, 2.23, 2.24, 3.27
Plan of correction, 2.11, 3.31, 5.4, 5.16
Form CMS-2567, 3.30
Privacy breach, 2.4, 2.5, 2.24
Privacy rights—SeePatient privacy rights
PSLS—SeePatient Safety Licensing Survey (PSLS)
Public notice, 2.25, 3.36
R
Recertification survey, 1.4
Record review, 3.18
Resurvey, 3.33, 3.34
S
S&C Memos, 3.10
Sole community hospital, 1.2
SOM—SeeState Operations Manual (SOM)
Specialty hospital, 1.2
Standard-level deficiency, 3.7, 3.23, 3.26
Statement of deficiencies
Form CMS-2567, 3.30
State monitoring, 3.33
State Operations Manual (SOM), 2.9, 3.7
State survey agency, 1.3
Survey, 4.9
Surveyors, 2.1
Survey procedures, 2.8, 3.7
T
Tags, 3.10
Termination
From Medicare/Medi-Cal, 3.34
The Joint Commission (TJC), 1.3, 1.4
Title 22, 2.6
TJC—SeeThe Joint Commission (TJC)
U
Unusual occurrence, 2.4, 2.5
V
Validation survey, 1.3, 3.3
HS-1 California Department of Public Health
Organization Chart
HS-2 Adverse Event Reporting Requirement
20-1 Adverse Event Report Form — Sample
HS-3 Privacy Breach Reporting Requirement
HS-4 Unusual Occurrences Reporting Requirement
HS-5 State-2567: Statement of Deficiencies and Plan of
Correction
HS-6 Maximum Time Frames Related to the Federal On-
Site Investigation of Complaints/Incidents
HS-7 Form CMS-2567: Statement of Deficiencies and
Plan of Correction
HS-8 Timeline for 90-Day Termination Track
HS-9 Timeline for 23-Day Termination Track
HS-10 Sample Cover Letter for Hospital’s CMS-2567
Response (for a CMS survey)
HS-11 Definitions of Hospitals Under California Law
HS-13 FAQs on Writing Hospital Policies and Procedures
HS-14 Instructions for Calculating an Administrative
Penalty (for non charity care, non privacy breach
violations)
CDPH Administrative Penalties: Scope and
Severity Matrix
(for non charity care, non privacy breach violations)
HS-15 Federal vs. State Immediate Jeopardy Definition
and Implementation Comparison
These documents are provided in English in the back of the manual. All forms can be found online for CHA members at
www.calhospital.org/free-resources.
List of Forms and Appendices
* Indicates forms that are new or revised in this edition.
APPENDIX HS-1
California Department of Public Health
Organization Chart
(11/20)
Page 1 of 1
©CALIFORNIA HOSPITAL ASSOCIATION
C
ALIFORNIA
D
EPARTMENT
OF
P
UBLIC
H
EALTH
Acting Director
Sandra Shewry, MPH, MSW
Acting State Public Health Officer
Erica S. Pan, MD, MPH
Office of Legislative and
Governmental Affairs
Monica Wagoner
Office of Health Equity
Mark Starr, DVM, MPVM
(Acting)
Office of Compliance
Monica Vazquez
California Conference of
Local Health Officers
Jake Hanson
Chief Deputy Director
of Operations
Brandon Nunes
Administration
Phuong La
Office of Legal Services
Drew Brereton
Center for Health
Statistics & Informatics
Scott Christman
Information Technology
Services
Gary Nodine
Director’s Office
Anjum Kapoor
Office of Quality
Performance &
Accreditation
Tara Naisbitt
Human Resources
Division
Kristanna Rivera
Chief Deputy Director of
Policy & Programs
Susan Fanelli
Center for Healthy
Communities
Mónica Morales
Center for Infectious
Diseases
Erica Pan, MD, MPH
Center for Family Health
Connie Mitchell, MD, MPH
Center for
Environmental Health
Mark Starr, DVM, MPVM
Emergency
Preparedness Office
Tricia Blocher
Assistant Director
Vacant
Center for Health Care
Quality
Heidi Steinecker
Office of
Communications
Ali Bay
Office of State Public
Health Laboratory Director
Paul Kimsey, PhD
Office of Policy and
Planning
Julie Nagasako
September 2020
APPENDIX HS-2
Adverse Event Reporting Requirement
(10/20)
Page 1 of 6
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Adverse Events Reporting
In response to media attention on medical errors, the California Legislature passed, and the
Governor signed, legislation requiring general acute care hospitals, psychiatric hospitals, and
special hospitals to report specified adverse events to CDPH. [Health and Safety Code Sections
1279.1, 1279.2, 1279.3 and 1280.4]
Outpatient settings must also report adverse events. “Outpatient settings” are defined as:
1. Any facility, clinic, unlicensed clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in [Health and Safety Code] Section 1250, and
where anesthesia, except local anesthesia or peripheral nerve blocks, or both, is used in
compliance with the community standard of practice, in doses that, when administered have
the probability of placing a patient at risk for loss of the patient’s life-preserving protective
reflexes. A clinic or ambulatory surgery center that does not meet this definition — i.e., does
not use general anesthesia — is not subject to this reporting requirement.
2. Facilities that offer in vitro fertilization, as defined in Health and Safety Code Section
1374.55(b).
Outpatient settings do not include, among other settings, any setting where anxiolytics and
analgesics are administered, when done so in compliance with the community standard of practice,
in doses that do not have the probability of placing the patient at risk for loss of the patient’s life-
preserving protective reflexes.
[Health and Safety Code Section 1248 and 1248.15]
CDPH has confirmed that distinct-part nursing facilities (DP-NFs) need not report adverse events
under this law. However, other reporting requirements may apply (for example, the “unusual
occurrences” reporting requirement may apply); see “Relationship With Other Reporting
Requirements,” page 5.
Types of Events that Must be Reported
For purposes of this reporting requirement, “adverse event” includes the surgical events, product
or device events, patient protection events, care management events, environmental events, criminal
events, and one other item described below. The term “serious disability,” which is used in many
places in the list of adverse events, means:
a physical or mental impairment that substantially limits one or more of the major life
activities of an individual, or the loss of bodily function, if the impairment or loss lasts
more than 7 days or is still present at the time of discharge from an inpatient health
facility, or the loss of a body part.
The list of adverse events includes the following.
Appendix HS-2 Adverse Event Reporting Requirement
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Surgical Events
1. Surgery performed on a wrong body part that is inconsistent with the documented informed
consent for that patient. This does not include a situation requiring prompt action that occurs
in the course of surgery or a situation that is so urgent as to preclude obtaining informed
consent.
2. Surgery performed on the wrong patient.
3. The wrong surgical procedure performed on a patient, which is a surgical procedure
performed on a patient that is inconsistent with the documented informed consent for that
patient. This does not include a situation requiring prompt action that occurs in the course of
surgery, or a situation that is so urgent as to preclude the obtaining of informed consent.
4. Retention of a foreign object in a patient after surgery or other procedure, excluding objects
intentionally implanted as part of a planned intervention and objects present prior to surgery
that are intentionally retained.
5. Death during or up to 24 hours after induction of anesthesia after surgery of a normal,
healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and
for whom the pathologic processes for which the operation is to be performed are localized
and do not entail a systemic disturbance.
Product or Device Events
1. Patient death or serious disability associated with the use of a contaminated drug, device,
or biologic provided by the health facility when the contamination is the result of generally
detectable contaminants in the drug, device, or biologic, regardless of the source of the
contamination or the product.
2. Patient death or serious disability associated with the use or function of a device in patient
care in which the device is used or functions other than as intended. For purposes of this
requirement, “device” includes, but it not limited to, a catheter, drain, or other specialized
tube, infusion pump, or ventilator.
3. Patient death or serious disability associated with intravascular air embolism that occurs
while being cared for in a facility, excluding deaths associated with neurosurgical procedures
known to present a high risk of intravascular air embolism.
Patient Protection Events
1. An infant discharged to the wrong person.
2. Patient death or serious disability associated with patient disappearance for more than four
hours, excluding events involving adults who have competency or decision-making capacity.
3. A patient suicide or attempted suicide resulting in serious disability while being cared for in
a health facility due to patient actions after admission to the health facility, excluding deaths
resulting from self-inflicted injuries that were the reason for the admission to the health
facility.
Appendix HS-2 Adverse Event Reporting Requirement
(10/20)
Page 3 of 6
©CALIFORNIA HOSPITAL ASSOCIATION
Care Management Events
1. A patient death or serious disability associated with a medication error, including, but not
limited to, an error involving the wrong drug, the wrong dose, the wrong patient, the wrong
time, the wrong rate, the wrong preparation, or the wrong route of administration, excluding
reasonable differences in clinical judgment on drug selection and dose.
2. A patient death or serious disability associated with a hemolytic reaction due to the
administration of ABO-incompatible blood or blood products.
3. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy
while being cared for in a facility, including events that occur within 42 days postdelivery and
excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy,
or cardiomyopathy.
4. Patient death or serious disability directly related to hypoglycemia, the onset of which occurs
while the patient is being cared for in a health facility.
5. Death or serious disability, including kernicterus, associated with failure to identify and
treat hyperbilirubinemia in neonates during the first 28 days of life. For purposes of this
requirement, “hyperbilirubinemia” means bilirubin levels greater than 30 milligrams per
deciliter.
6. A Stage 3 or 4 ulcer, acquired after admission to a health facility, excluding progression from
Stage 2 to Stage 3 if Stage 2 was recognized upon admission. (See AFL 15-03.1 regarding
unstageable pressure ulcers at https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/AFL-
15-03.aspx.)
7. A patient death or serious disability due to spinal manipulative therapy performed at the
health facility.
Environmental Events
1. A patient death or serious disability associated with an electric shock while being cared
for in a health facility, excluding events involving planned treatments, such as electric
countershock.
2. Any incident in which a line designated for oxygen or other gas to be delivered to a patient
contains the wrong gas or is contaminated by a toxic substance.
3. A patient death or serious disability associated with a burn incurred from any source while
the patient is being cared for in a health facility.
4. A patient death associated with a fall while the patient is being cared for in a health facility.
5. A patient death or serious disability associated with the use of restraints or bedrails while
being cared for in a health facility.
Appendix HS-2 Adverse Event Reporting Requirement
Page 4 of 6
(10/20)
©CALIFORNIA HOSPITAL ASSOCIATION
Criminal Events
1. Any instance of care ordered by or provided by someone impersonating a physician, nurse,
pharmacist, or other licensed health care provider.
2. The abduction of a patient of any age.
3. The sexual assault of a patient within or on the grounds of a health facility.
4. The death or significant injury of a patient or staff member resulting from a physical assault
that occurs within or on the grounds of a facility.
Final Item
The list of adverse events specified in the law contains a final item that contains a circular definition.
The final “catchall” category to be reported is “an adverse event or series of adverse events that
cause the death or serious disability of a patient, personnel, or visitor.” However, an “adverse
event” is defined as those events listed above (surgical events, product or device events, patient
protection events, care management events, environmental events, and criminal events). Therefore,
the final category arguably does not capture any events that are not already described in the law.
Hospitals that are considering reporting an event under the “catchall” category should consult legal
counsel to determine whether a report under this law is required. Even if a report under this law
is determined not to be required, however, hospitals may need to report the incident pursuant to
another reporting requirement. (See “Relationship With Other Reporting Requirements,” page .)
Required Time Frame for Reporting
The report must be made no later than five days after the adverse event has been detected.
However, if the adverse event is an ongoing urgent or emergent threat to the welfare, health, or
safety of patients, personnel, or visitors, the report must be made not later than 24 hours after the
adverse event has been detected.
How to Report
CDPH has developed a web-based reporting tool that health care facilities may use to report
adverse events as well as privacy breaches, called the “California Healthcare Event and Reporting
Tool” (CalHEART). Information about the online reporting tool may be found in CDPH All Facilities
Letter 13-12 at https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/LNCAFL2013.aspx.
Hospitals are not required to use this tool; a paper form may be submitted instead. CHA has
developed a form, “Adverse Event Report Form” (CHA Form 20-1), that hospitals may use to report
an adverse event to CDPH. CDPH has stated it will accept the CHA form. However, CDPH has
issued proposed regulations about adverse event reporting. After the regulations are finalized and in
effect, hospitals will be required to report electronically and additional information may be required.
Communication With Affected Patient(s)
The hospital must inform the patient or the party responsible for the patient of the adverse event by
the time the report is made. In addition, The Joint Commission requirement regarding informing the
patient of unanticipated outcomes of care may apply. (See CHA’s Consent Manual, chapter 19.)
Appendix HS-2 Adverse Event Reporting Requirement
(10/20)
Page 5 of 6
©CALIFORNIA HOSPITAL ASSOCIATION
Relationship With Other Reporting Requirements
This law does not change or otherwise affect other hospital reporting requirements regarding
reportable diseases or unusual occurrences. Hospitals may also need to report adverse events
according to the following requirements:
1. Unusual occurrences — see CHA Appendix HS-4.
2. Safe Medical Devices Act — see CHA’s Consent Manual, chapter 19.
3. Restraint death reporting — see CHA’s Consent Manual, chapter 19.
4. Medication errors — see CHA’s Consent Manual, chapter 19.
5. Injuries by firearm or assaultive or abusive conduct — see CHA’s Consent Manual, chapter
17.
6. Violence against hospital personnel — see CHA’s guidebook, “Healthcare Workplace
Violence Prevention - How to Comply with the Cal/OSHA Regulation,” available at https://
www.calhospital.org/publication/healthcare-workplace-violence-prevention.
7. Radiation overdose — see CHA’s Consent Manual, chapter 19.
In addition, a root cause analysis pursuant to The Joint Commission’s sentinel event requirements
may be required. (See CHA’s Consent Manual, chapter 19.)
CDPH Investigations and Reports
Ongoing Threat of Imminent Danger
CDPH must make an on-site inspection or investigation whenever it receives an adverse event
report or a complaint indicating an ongoing threat of imminent danger of death or serious bodily
harm. The on-site inspection or investigation must take place within 48 hours or two business
days (whichever is greater) after receipt of the report or complaint. The investigation must be
completed within 45 days. If CDPH does not meet this timeframe, it must provide written notice to
the facility and the complainant (if any) of the basis for the extenuating circumstances preventing it
from meeting the timeframe, and the anticipated completion date. Until CDPH determines by on-
site inspection that the adverse event has been resolved, CDPH must conduct an unannounced
inspection at least once per year of any hospital that has reported an adverse event.
No Threat of Imminent Danger
If CDPH receives a complaint or report but determines from the information available to it that there
is no threat of imminent danger of death or serious bodily harm to that patient or other patients, no
on-site inspection is required, but an investigation must be undertaken and completed within 45
days. If CDPH does not meet this time frame, it must provide written notice to the facility and the
complainant (if any) of the basis for the extenuating circumstances preventing it from meeting the
time frame, and the anticipated completion date.
Definition
For purposes of this law, a “complaint” means any oral or written notice to CDPH (other than an
adverse event report from the hospital) of an alleged violation of any applicable state or federal law,
or an allegation of facts that might constitute such a violation.
Appendix HS-2 Adverse Event Reporting Requirement
Page 6 of 6
(10/20)
©CALIFORNIA HOSPITAL ASSOCIATION
Follow-Up
CDPH must notify the hospital and the complainant in writing of its determination as a result of its
investigation.
CDPH Public Reporting of Adverse Events
CDPH provides information about substantiated adverse events and the outcomes of inspections
and investigations on its website by posting the hospital’s Statement of Deficiencies (CDPH Form
2567) and the hospital’s plan of correction.
The information provided by CDPH names individual hospitals and may include compliance
information history. The names of patients, health care professionals and other health care workers
will not be divulged by CDPH.
Penalties for Failure to Report
The adverse event reporting law contains specific penalties for failure to report. A hospital that fails
to report an adverse event may be assessed a civil penalty in an amount not to exceed $100 per
day for each day that the adverse event is not reported following the initial five-day period or 24-
hour period, as applicable. If the hospital disputes a determination by CDPH regarding an alleged
failure to report an adverse event, the hospital may, within 10 days, request a hearing pursuant to
Health and Safety Code Section 100171. Penalties do not have to be paid until all appeals have
been exhausted.
CDPH has additional authority to fine hospitals for failing to comply with hospital licensing
requirements. It is unclear whether both fines may apply, or if CDPH is limited to assessing penalties
under this provision.
FORM 20-1
Adverse Event Report Form — Sample
(10/18)
Page 1 of 4
CALIFORNIA HOSPITAL ASSOCIATION
[HOSPITAL LETTERHEAD]
(Must include hospital name and address elsewhere
if this form is not reproduced on hospital letterhead)
[Date of report]
State of California, Department of Public Health
Licensing and Certification District Office
[Street Address]
[City], CA [ZIP]
To Whom It May Concern:
This hospital believes it may have detected the adverse event indicated below as defined in Health
and Safety Code Section 1279.1, and is hereby reporting pursuant to Health and Safety Code
Section 1279.1.
Due to the short time frame required for reporting in the law, the information this hospital has may
be incomplete. If further investigation shows that no adverse event as defined in this law took place,
you will be notified. However, in order to comply with the law’s short time frame, this hospital is
taking a precautionary measure and reporting accordingly.
This hospital may have detected the adverse event checked below:
□ 1. Surgery performed on a wrong body part that is inconsistent with the documented
informed consent for that patient. This does not include a situation requiring prompt
action that occurs in the course of surgery or a situation that is so urgent as to preclude
obtaining informed consent.
□ 2. Surgery performed on the wrong patient.
□ 3. The wrong surgical procedure performed on a patient, which is a surgical procedure
performed on a patient that is inconsistent with the documented informed consent for that
patient. This does not include a situation requiring prompt action that occurs in the course
of surgery or a situation that is so urgent as to preclude obtaining informed consent.
□ 4. Retention of a foreign object in a patient after surgery or other procedure, excluding
objects intentionally implanted as part of a planned intervention and objects present prior
to surgery that are intentionally retained.
□ 5. Death during or up to 24 hours after induction of anesthesia after surgery of a normal,
healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance
and for whom the pathologic processes for which the operation is to be performed are
localized and do not entail a systemic disturbance.
Form 20-1 Adverse Event Report Form — Sample
Page 2 of 4
(10/18)
CALIFORNIA HOSPITAL ASSOCIATION
□ 6. Patient death or serious disability associated with the use of a contaminated drug,
device, or biologic provided by the health facility when the contamination is the
result of generally detectable contaminants in the drug, device, or biologic,
regardless of the source of the contamination or the product.
□ 7. Patient death or serious disability associated with the use or function of a device in
patient care in which the device is used or functions other than as intended. For
purposes of this subparagraph, “device” includes, but it not limited to, a catheter, drain,
or other specialized tube, infusion pump, or ventilator.
□ 8. Patient death or serious disability associated with intravascular air embolism that occurs
while being cared for in a facility, excluding deaths associated with neurosurgical
procedures known to present a high risk of intravascular air embolism.
□ 9. An infant discharged to the wrong person.
□ 10. Patient death or serious disability associated with patient disappearance for more than
four hours, excluding events involving adults who have competency or decision making
capacity.
□ 11. A patient suicide or attempted suicide resulting in serious disability while being cared
for in a health facility due to patient actions after admission to the health facility,
excluding deaths resulting from self-inflicted injuries that were the reason for
the admission to the health facility.
□ 12. A patient death or serious disability associated with a medication error, including, but not
limited to, an error involving the wrong drug, the wrong dose, the wrong patient, the
wrong time, the wrong rate, the wrong preparation, or the wrong route of administration,
excluding reasonable differences in clinical judgment on drug selection and dose.
□ 13. A patient death or serious disability associated with a hemolytic reaction due to the
administration of ABO-incompatible blood or blood products.
□ 14. A maternal death or serious disability associated with labor or delivery in a low-risk
pregnancy while being cared for in a facility, including events that occur within 42 days
postdelivery and excluding deaths from pulmonary or amniotic fluid embolism, acute fatty
liver of pregnancy, or cardiomyopathy.
□ 15. Patient death or serious disability directly related to hypoglycemia, the onset of which
occurs while the patient is being cared for in a health facility.
□ 16. Death or serious disability, including kernicterus, associated with failure to identify and
treat hyperbilirubinemia in neonates during the first 28 days of life. For purposes of this
subparagraph, “hyperbilirubinemia” means bilirubin levels greater than 30 miligrams per
deciliter.
□ 17. A Stage 3 or 4 ulcer, acquired after admission to a health facility, excluding progression
from Stage 2 to Stage 3 if Stage 2 was recognized upon admission.
□ 18. A patient death or serious disability due to spinal manipulative therapy performed at the
health facility.
Form 20-1 Adverse Event Report Form — Sample
(10/18)
Page 3 of 4
CALIFORNIA HOSPITAL ASSOCIATION
□ 19. A patient death or serious disability associated with an electric shock while being
cared for in a health facility, excluding events involving planned treatments, such as
electric countershock.
□ 20. Any incident in which a line designated for oxygen or other gas to be delivered to a
patient contains the wrong gas or is contaminated by a toxic substance.
□ 21. A patient death or serious disability associated with a burn incurred from any source
while being cared for in a health facility.
□ 22. A patient death associated with a fall while being cared for in a health facility.
□ 23. A patient death or serious disability associated with the use of restraints or bedrails while
being cared for in a health facility.
□ 24. Any instance of care ordered by or provided by someone impersonating a physician,
nurse, pharmacist, or other licensed health care provider.
□ 25. The abduction of a patient of any age.
□ 26. The sexual assault of a patient within or on the grounds of a health facility.
□ 27. The death or significant injury of a patient or staff member resulting from a physical
assault that occurs within or on the grounds of a facility. [Note: if this item is checked
because a staff member suffered death or significant injury due to a physical assault
on the grounds of the facility, please indicate the staff member’s name at the bottom
of the form, rather than a patient’s name.]
□ 28. An adverse event or series of adverse events that cause the death or serious disability
of a patient, personnel, or visitor. [Note: An “adverse event” is defined as the incidents
described in items 1. through 27., above. Thus, this category probably does not capture
any additional adverse events not described in items 1. through 27. above. If for some
reason an adverse event report is made about an event not listed in items 1. through 27.
above, a brief description of the event should be included on this form. If a hospital
has an adverse event that causes the death or serious disability of a patient, personnel,
or visitor but is not listed above in items 1. through 27., legal counsel should be
consulted to determine whether it should be reported. A different reporting
requirement may apply.]
Hospital’s code to link this report to its file regarding this potential adverse event:
Date hospital detected the adverse event:
Please contact me at [insert phone number] or at [insert fax number] if you require further
information.
Sincerely,
[Name]
[Title]
(over)
Form 20-1 Adverse Event Report Form — Sample
Page 4 of 4
(10/18)
CALIFORNIA HOSPITAL ASSOCIATION
NOTE: “Serious disability” means:
a. A physical or mental impairment that substantially limits one or more of the major life
activities of an individual, if the impairment lasts more than seven days or is still present at
the time of discharge from an inpatient health care facility, or
b. The loss of bodily function, if the loss lasts more than seven days or is still present at the
time of discharge from an inpatient health care facility, or
c. The loss of a body part.
*Generally, this report must be made within five days of detection. However, if the adverse event
is an ongoing or urgent threat to the welfare, health, or safety of patients, personnel or visitors, a
report must be made within 24 hours of detection.
APPENDIX HS-4
Unusual Occurrences Reporting Requirement
(11/20)
Page 1 of 1
©CALIFORNIA HOSPITAL ASSOCIATION
Reportable “Unusual Occurrences”
Hospitals are required to notify CDPH immediately, via telephone, of the following:
1. Any discontinuance or disruption of services;
2. Upon the threat of a walkout of a substantial number of employees; or
3. An earthquake, fire, power outage or other calamity that causes damage to the facility or
threatens the safety or welfare of patients or clients.
[Title 22, California Code of Regulations, Sections 70746 (general acute care hospitals), 71544
(acute psychiatric hospitals)]
Title 22 also requires general acute care hospitals and acute psychiatric hospitals to report by
phone any occurrence such as an epidemic outbreak, poisoning, fire, major accident, disaster,
other catastrophe or unusual occurrence that threatens the welfare, safety, or health of patients,
personnel, or visitors, as soon as reasonably practicable, to the local health officer and to CDPH.
The hospital must furnish other pertinent information related to the occurrence as may be requested
by the local health officer or CDPH. [Title 22, California Code of Regulations, Sections 70737
(general acute care hospital) and 71535 (acute psychiatric hospital)].
Exactly which types of incidents constitute an “unusual occurrence” has not been further clarified
by CDPH. CDPH is aware that its employees as well as hospital employees have inconsistent
interpretations of this requirement. CDPH has indicated that the following events should be reported
as unusual occurrences:
1. Sentinel events as defined by the Joint Commission, even if the hospital does not report the
event to The Joint Commission. (See CHA’s Consent Manual, chapter 19, regarding sentinel
events.)
2. A patient death that occurs while a patient is restrained or in seclusion for behavior
management.
3. Incidents that are covered by the news media.
4. An emergency or disaster-related occurrence that results in a patient evacuation, transfer, or
discharge [All Facilities Letter 17-06 (Mar. 13, 2017)].
5. Public Safety Power Shutoff power outages [All Facilities Letter 18-48 (Nov. 13, 2018)].
6. However, CDPH has not promulgated regulations regarding these informal interpretations.
How to Report
During normal business hours, the hospital should contact the local CDPH Licensing and
Certification district office it customarily works with. For after-hours reporting, or if the local district
office is non-operational due to an emergency or disaster, hospitals in Los Angeles County should
contact the Los Angeles County Operator at (213) 974-1234 and ask the operator to notify the on-
call Health Facilities Inspection Division supervisor. Hospitals outside Los Angeles County should
contact the CDPH duty officer at (916) 328-3605.
The hospital should document that notification was made.
APPENDIX HS-5
State-2567: Statement of Deficiencies and Plan
of Correction
(01/12)
Page 1 of 1
©CALIFORNIA HOSPITAL ASSOCIATION
APPENDIX HS-6
Maximum Time Frames Related to the Federal
On-Site Investigation of Complaints/Incidents
(11/20)
Page 1 of 2
©CALIFORNIA HOSPITAL ASSOCIATION
INTAKE PRIORITIZATION
Provider
Type
Immediate
Jeopardy (IJ)
(Noncompliance
caused serious
injury, harm,
impairment, or
death of a patient,
or the likelihood
of such, and there
continues to be
an immediate risk
unless immediate
corrective action is
taken.)
Non-IJ: High
(Noncompliance would
not represent an IJ, but
indicates a condition-
level deficiency)
Non-IJ:
Medium
(Noncompliance
is limited in
manner and
degree and/or
caused or may
cause harm
that is of limited
consequence
and does not
impair the
individual’s
mental,
physical and/
or psychosocial
status or
function)
Non-IJ: Low
(Noncompliance
may have
caused physical,
mental and/or
psychosocial
discomfort
that does not
constitute injury
or damage)
Deemed
hospitals
SA must initiate an
on-site survey within
2 business days
of receipt of RO
authorization.
SA must initiate an
on-site survey within
45 calendar days
of receipt of RO
authorization.
Complaint is
referred to the
applicable
accrediting
organization(s).
Complaint is
referred to the
applicable
accrediting
organization(s).
Non-deemed
hospitals
SA must initiate an
on-site survey within
2 business days
of receipt of RO
authorization.
SA must initiate an
on-site survey within
45 calendar days
after prioritization of
complaint.
SA must
investigate no
later than the
next on-site
survey.
SA must
track/trend for
potential focus
areas for the
next on-site
survey. SA has
the discretion
to initiate a
survey based on
trending.
EMTALA SA must initiate an
on-site survey within
2 business days
of receipt of RO
authorization.
SA must initiate an
on-site survey within
45 calendar days
of receipt of RO
authorization.
N/A N/A
Appendix HS-6 Maximum Time Frames Related to the Federal On-Site Investigation of Complaints/Incidents
Page 2 of 2
(11/20)
©CALIFORNIA HOSPITAL ASSOCIATION
INTAKE PRIORITIZATION
Provider Type Immediate
Jeopardy (IJ)
(Noncompliance
caused serious
injury, harm,
impairment, or death
of a patient, or the
likelihood of such,
and there continues
to be an immediate
risk unless
immediate corrective
action is taken.)
Non-IJ: High
(Noncompliance
would not
represent an IJ,
but indicates a
condition-level
deficiency)
Non-IJ:
Medium
(Noncompliance
is limited in
manner and
degree and/or
caused or may
cause harm
that is of limited
consequence
and does not
impair the
individual’s
mental,
physical and/
or psychosocial
status or
function)
Non-IJ: Low
(Noncompliance
may have
caused physical,
mental and/or
psychosocial
discomfort
that does not
constitute injury
or damage)
Death
associated with
restraint/seclusion
used for behavior
management
SA must initiate an
on-site survey within
2 business days
of reciept of RO
authorization.
N/A
(All such
complaints are
considered IJs)
N/A
(All such
complaints are
considered IJs)
N/A
(All such
complaints are
considered IJs)
Fire resulting in
serious injury or
death
SA must initiate an
on-site survey within
2 business days
of receipt of RO
authorization.
N/A
(All such
complaints are
considered IJs)
N/A
(All such
complaints are
considered IJs)
N/A
(All such
complaints are
considered IJs)
NOTES:
1. SA=State Survey Agency, which in California is the California Department of Public Health.
RO=Regional Office of the Centers for Medicare & Medicaid Services.
2. Generally, an alleged event occurring more than 12 months prior to a complaint will not
trigger a complaint investigation. However, the State Survey Agency may conduct an
investigation to determine current compliance status based on concerns identified in the
complaint.
.
Source: State Operations Manual, Chapter 5 — Complaint Procedures, Section 5075.9
APPENDIX HS-7
Form CMS-2567: Statement of Deficiencies and
Plan of Correction
(02/99)
Page 1 of 2
©CALIFORNIA HOSPITAL ASSOCIATION
Appendix HS-7 Form CMS-2567: Statement of Deficiencies and Plan of Correction
Page 2 of 2
(02/99)
©CALIFORNIA HOSPITAL ASSOCIATION
APPENDIX HS-8
Timeline for 90-Day Termination Track
(11/12)
Page 1 of 1
©CALIFORNIA HOSPITAL ASSOCIATION
Applies when the hospital has condition-level deficiencies
Friday, July 1
Last day of survey
Monday, July 18
10 working days past survey (weekends and holidays do not count),
CMS sends a warning letter and the CMS-2567 report to the hospital
Thursday, July 28
10 calendar days past survey — Hospital’s 2567 response due
Monday, August 15
45 calendar days past survey. If hospital’s 2567 makes a credible allegation of
compliance, then the State Agency should conduct a resurvey by this date.
If hospital has condition-level deficiencies upon resurvey, it can use this time to
submit a second 2567 response. If a credible allegation of compliance is found,
CMS may authorize the State Agency to perform a 2nd resurvey.
Friday, September 9
70 calendar days past survey. Official termination notice sent by CMS to the hospital.
Public notified. Notice must be sent at least 15 days before termination.
TERMINATION DATE — Thursday, September 29
90 calendar days past survey
APPENDIX HS-9
Timeline for 23-Day Termination Track
(01/12)
Page 1 of 1
©CALIFORNIA HOSPITAL ASSOCIATION
Applies when the hospital has not corrected the IJ by the survey conclusion
Last Day of Survey
2nd Working Day
State Agency notifies hospital by overnight mail or fax of immediate jeopardy (IJ) deficiency
and that it is recommending termination to CMS, which will issue a formal notice.
5th Working Day
CMS notifies hospital and the public (local newspaper) of impending termination and requests an
acceptable PoC.
10th Working Day
CMS-2567 report due to hospital regarding any additional non-IJ deficiencies
Termination will take effect on day 23 unless the hospital has achieved compliance
or removed the threat. If the threat has been removed but deficiencies still exist at the
condition-level, the hospital will shift to the 90-day termination track.
23rd Calendar Day — Termination
APPENDIX HS-10
Sample Cover Letter for Hospital’s CMS-2567
Response (for a CMS survey)
(01/12)
Page 1 of 2
©CALIFORNIA HOSPITAL ASSOCIATION
[on hospital letterhead]
[Date]
[Name of CMS official — the CMS cover letter should indicate where the hospital should send its
response]
[Title]
[Address]
and
[Name of CDPH official (if indicated in the CMS cover letter)]
[Title]
[Address]
Re: [Name of Hospital]
Medicare Provider Number [xx-xxxx]
Dear _____________________________:
Enclosed please find [Name of Hospital]’s responses to the Statement of Deficiencies, Form CMS-
2567, that was issued as a result of the CMS survey that ended on [insert survey end date].
In responding to the deficiencies noted, [Name of Hospital] has applied the “credible allegation of
compliance” standard that is described in the State Operations Manual. We understand the protocol
is that CMS will assess whether [Name of Hospital]’s 2567 responses reflect a credible allegation
of compliance sufficient to merit a resurvey to confirm that the corrections were in fact made in a
manner that brings the hospital back into compliance with the Medicare Conditions of Participation.
[Name of Hospital] has prepared, and has available for review on-site, a compilation of the relevant
supporting documentation (policies, forms, monitoring instruments, etc.). Please let us know
immediately if some other protocol is expected, or if you have any questions about our submission.
As you will see when you review our submission, much work has been done to respond to each
and every finding. [Name of Hospital] has elected not to challenge any of the facts at this time —
although this submission should not be viewed as an admission, and the hospital reserves its right
to appeal.
On behalf of the many dedicated staff members of [Name of Hospital] who have committed
themselves to maintaining [Name of Hospital]’s Medicare certification so that the hospital may
Appendix HS-10 Sample Cover Letter for Hospital’s CMS-2567 Response (for a CMS survey)
Page 2 of 2
(01/12)
©CALIFORNIA HOSPITAL ASSOCIATION
continue to serve Medicare and Medi-Cal patients in our community, we ask that CMS and CDPH
use their very best efforts to promptly review our submission, immediately contact us for any
clarifications or additional documentation that may be needed, and conduct a resurvey as quickly as
possible.
We are available to meet with you, in person or by telephone, to further explain our actions and/or
provide any additional information or documentation you may require.
Sincerely,
[CEO Name]
Chief Executive Officer
Enclosures: Form CMS-2567 response
Other attachments as appropriate (for example, documentation supporting disputed facts)
APPENDIX HS-11
Definitions of Hospitals Under California Law
(07/15)
Page 1 of 2
©CALIFORNIA HOSPITAL ASSOCIATION
General Acute Care Hospital
A “general acute care hospital” is defined in Health and Safety Code Section 1250(a) as:
a health facility having a duly constituted governing body with overall administrative and
professional responsibility and an organized medical staff that provides 24-hour inpatient
care, including the following basic services: medical, nursing, surgical, anesthesia,
laboratory, radiology, pharmacy, and dietary services. A general acute care hospital may
include more than one physical plant maintained and operated on separate premises as
provided in Section 1250.8. A general acute care hospital that exclusively provides acute
medical rehabilitation center services, including at least physical therapy, occupational
therapy, and speech therapy, may provide for the required surgical and anesthesia services
through a contract with another acute care hospital. In addition, a general acute care hospital
that, on July 1, 1983, provided required surgical and anesthesia services through a contract
or agreement with another acute care hospital may continue to provide these surgical
and anesthesia services through a contract or agreement with an acute care hospital. The
general acute care hospital operated by the State Department of Developmental Services
at Agnews Developmental Center may, until June 30, 2007, provide surgery and anesthesia
services through a contract or agreement with another acute care hospital. Notwithstanding
the requirements of this subdivision, a general acute care hospital operated by the
Department of Corrections and Rehabilitation or the Department of Veterans Affairs may
provide surgery and anesthesia services during normal weekday working hours, and not
provide these services during other hours of the weekday or on weekends or holidays, if the
general acute care hospital otherwise meets the requirements of this section.
A “general acute care hospital” includes a “rural general acute care hospital.” However, a
“rural general acute care hospital” shall not be required by the department [the California
Department of Public Health] to provide surgery and anesthesia services. A “rural general
acute care hospital” shall meet either of the following conditions:
(1) The hospital meets criteria for designation within peer group six or eight, as defined in the
report entitled Hospital Peer Grouping for Efficiency Comparison, dated December 20,
1982.
(2) The hospital meets the criteria for designation within peer group five or seven, as defined
in the report entitled Hospital Peer Grouping for Efficiency Comparison, dated December
20, 1982, and has no more than 76 acute care beds and is located in a census dwelling
place of 15,000 or less population according to the 1980 federal census.
Acute Psychiatric Hospital
An “acute psychiatric hospital” is defined in Health and Safety Code Section 1250(b) as:
a health facility having a duly constituted governing body with overall administrative and
professional responsibility and an organized medical staff that provides 24-hour inpatient
care for persons with mental health disorders or other patients referred to in Division 5
Appendix HS-11 Definitions of Hospitals Under California Law
Page 2 of 2
(07/15)
©CALIFORNIA HOSPITAL ASSOCIATION
(commencing with Section 5000) or Division 6 (commencing with Section 6000) of the
Welfare and Institutions Code, including the following basic services: medical, nursing,
rehabilitative, pharmacy, and dietary services.
Special Hospital
A “special hospital” is defined in Health and Safety Code Section 1250(f) as:
a health facility having a duly constituted governing body with overall administrative and
professional responsibility and an organized medical or dental staff that provides inpatient or
outpatient care in dentistry or maternity.
Specialty Hospital
There is no definition in California law for a “specialty” hospital, which is typically a hospital that
specializes in cardiac care or orthopaedic care. In California, these hospitals are licensed as general
acute care hospitals under Health and Safety Code Section 1250(a). A general acute care hospital
is not required to have an emergency department, although most do.
APPENDIX HS-13
FAQs on Writing Hospital Policies and
Procedures
(10/20)
Page 1 of 3
©CALIFORNIA HOSPITAL ASSOCIATION
What is the purpose of hospital policies and procedures?
Hospital policies and procedures (P&Ps) are tools to guide staff towards accomplishing the
hospital’s goals, and to ensure compliance with federal and state legal requirements as well as
applicable accreditation standards.
What is the difference between a policy and a procedure?
A policy is a written document that guides a particular activity or service by establishing a
framework for both management and staff. It is broadly written to address minimum legal
requirements and specifies responsibility for action. Given their broad framework, hospital policies
are reviewed periodically, but do not typically require substantial changes to remain compliant with
current legal requirements.
A procedure, on the other hand, contains more detailed requirements to ensure compliance with
the policy. A procedure is a sequence of steps for completing a given activity. A procedure can also
outline the manner in which a particular policy should be implemented. Since procedures are more
detailed and sequential, they are typically updated and revised more frequently. Hospitals often
combine a policy and related procedures into a single document.
Why is it important to critically evaluate hospital P&Ps?
Critically evaluating the need for a hospital P&P, and its content, is important for a number of
reasons. First, these documents create hospital-wide standards of care, and establish minimum
expectations and responsibilities required for compliance with current law (and accreditation
standards). As a written expression of the hospital standard of care, hospital P&Ps can be used in
litigation to attack or defend the care or services delivered. Equally important, hospital P&Ps can
become, in essence, regulatory requirements: government and accreditation organization surveyors
can cite a hospital for failure to follow its P&Ps, even if the steps outlined in the P&P would not
otherwise be legally required. When creating a new P&P (or evaluating an existing one), stop and
consider if the document should really be a P&P, or if it is an operational objective, departmental
goal, or new enterprise or program that does not necessitate a P&P. Limiting the number of P&Ps to
those really necessary for compliance with the law and accreditation standards is an important way
to manage hospital compliance and risk.
How should a hospital P&P be written?
A hospital P&P should be clear, concise, and easy to understand. It should establish the minimum
expectations for a particular activity or service. To the extent possible, hospital P&Ps should be
written using the exact wording contained in the regulation or statute, and avoid including any
additional requirements or specific responsibilities not required by the law. Keep it practical, and
consistent with the essential legal requirements. Above all, it should be written to express the
minimum necessary actions required for compliance, as expressed in law.
Appendix HS-13 FAQs on Writing Hospital Policies and Procedures
Page 2 of 3
(10/20)
©CALIFORNIA HOSPITAL ASSOCIATION
What are some characteristics of a good hospital P&P?
A good hospital P&P is concise, practical, and able to be performed. It should be written with a
critical eye toward implementation and performance. Develop and test the content and wording
contained in each hospital P&P, seeking input from clinicians and administrators who are impacted
by it, to ensure it is clear, concise, and can be easily understood and implemented, using wording
that mirrors the essential legal requirements.
What are some things to avoid in writing a hospital P&P?
Remember, your hospital will be surveyed to ensure that staff is following hospital P&Ps, so the
choice of words used is critical. Avoid wording that inadvertently raises the standard of conduct
beyond the essential legal requirements. For example, do not use “must” if “may” will suffice. Avoid
using specific terms and sequences when the law uses general descriptors or objectives (e.g.,
do not use the word “physician” when “qualified health care provider” will suffice). Another trap
is to insert future requirements or goals into hospital P&Ps. Because hospital P&Ps apply when
adopted, make sure the ability to meet them exists when they are adopted. Another trap in writing
hospital P&Ps is to include additional information or insert specific requirements that are not legally
essential. This additional content should be documented elsewhere, and not in a hospital P&P.
Remember, hospital P&Ps effectively become regulatory standards. The lesson here is that hospital
P&Ps provide a road map for surveyors to evaluate staff knowledge of the content (less is more),
and consistent implementation of legally and self-imposed requirements.
Are there examples of how word choices matter?
Yes, choose words that are consistent with the essence of the legal requirement. If possible, use
words and phrases directly from the law. An example of a hospital P&P that went awry, and resulted
in a lawsuit and hospital liability, was an emergency department P&P that required every patient
to be evaluated by a “triage nurse” and seen by an “emergency physician” prior to discharge. A
particular patient that subsequently died was seen by a physician, but he was not a specialist in
emergency medicine. The court determined that the hospital was negligent because it didn’t follow
its own policy, and was therefore liable for the patient’s injuries. The lesson here is to choose the
words carefully. This hospital may have avoided liability by indicating each patient would be triaged
by a “qualified health care professional” and evaluated by a “licensed and credentialed member of
the medical staff.”
What is an example of a P&P requirement that may be impossible to perform?
A hospital P&P that may be impossible to perform is one that requires the hospital to ensure the
performance of actions by a third party. For example, a hospital P&P may state that the hospital
shall ensure that each physician on its medical staff provides discharge instructions to the patient
prior to discharge. This policy objective is ideal; however, the P&P itself places responsibility directly
on the hospital for the action or inaction of third parties (physicians who are not employed by the
hospital, and therefore not under its control). The physician may not be the health care professional
who reviews the discharge instructions with the patient.
Appendix HS-13 FAQs on Writing Hospital Policies and Procedures
(10/20)
Page 3 of 3
©CALIFORNIA HOSPITAL ASSOCIATION
What should a hospital do if it identifies P&Ps that are not required?
If a hospital P&P is not legally required, the hospital should consider withdrawing it or revising it to
indicate it is a recommendation for staff, not a mandatory P&P. Remember, a hospital P&P becomes
essentially a performance standard of care that it will be surveyed against — and can be used in
litigation to sue the hospital for falling below the standard of care.
APPENDIX HS-14
Instructions for Calculating an Administrative
Penalty (for non charity care, non privacy breach violations)
(08/15)
Page 1 of 2
©CALIFORNIA HOSPITAL ASSOCIATION
Using the attached Scope and Severity Matrix, choose the appropriate initial penalty. Make the
following adjustments as applicable:
Initial Penalty Adjustments
1. Actual patient harm:
Increase penalty by 10% for actual harm to the patient at Severity Level 3 or 5 resulting in a
physical or mental impairment that substantially limits one or more of the major life activities of a
patient, or the loss of bodily function, if the impairment or loss lasts more than seven days or is
still present at the time of discharge from the hospital, or the loss of a body part.
OR
Increase penalty by 5% for actual harm to the patient at Severity Level 3 or 5 resulting in a physical
or mental impairment that substantially limits one or more of the major life activities of a patient, or
the loss of bodily function, if the impairment or loss lasts more than three days.
2. Financial Harm: Increase penalty by 1% for actual financial harm to the patient, based on
information acquired by CDPH during the normal course of the investigation.
3. Beyond the Hospital’s Control: Decrease the penalty by 5% for factors beyond the
hospital’s control that restrict the hospital’s ability to comply with the requirements of
licensure, if the hospital developed and maintained disaster and emergency programs as
required by state and federal law that were appropriately implemented during a disaster.
4. Willful Violation: Increase the penalty by 10% if this was a willful violation.
Final Base Penalty Adjustments
5. Immediate Correction: Decrease the penalty by 20% if all of the following can be
answered “yes”:
a. The noncompliance was an event that the hospital was required to report to CDPH and the
hospital self-reported the noncompliance to CDPH before it was identified by CDPH.
b. The hospital identified and immediately corrected the noncompliance before it was identified
by CDPH.
c. The noncompliance that was corrected did not constitute immediate jeopardy, or result in the
death of a patient.
d. The penalty was not imposed for a repeat deficiency that received a penalty reduction within
the prior 12 months.
6. Single Deficiency in Three Years: Decrease the penalty by 5% if this is the only deficiency
in the last three years that resulted in patient harm or immediate jeopardy.
Appendix HS-14 Instructions for Calculating an Administrative Penalty (for non charity care, non privacy breach violations)
Page 2 of 2
(08/15)
©CALIFORNIA HOSPITAL ASSOCIATION
7. Repeat Violations: Increase the penalty by 5% if the hospital has had three or more
repeated deficiencies that posed a risk of more than minimal harm to patient health or
safety within the last three years, including the deficiency that is the subject of this penalty
calculation.
Maximum Penalty
8. Maximum Penalty: The maximum penalty is $25,000 for a violation not constituting an
IJ, $75,000 for a first IJ penalty, $100,000 for a second IJ penalty, $125,000 for a third IJ
penalty, and $25,000 for a non-IJ penalty.
CDPH Administrative Penalties:
Scope and Severity Matrix
(for non charity care, non privacy breach violations)
(11/18)
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©CALIFORNIA HOSPITAL ASSOCIATION
ISOLATED PATTERN WIDESPREAD
SEVERITY LEVEL 6
(Immediate jeopardy to
patient health or safety,
resulting in death)
1st IJ penalty: $75,000
2nd IJ penalty: $100,000
3rd IJ penalty: $125,000
(100% of maximum IJ
penalty)
1st IJ penalty: $75,000
2nd IJ penalty: $100,000
3rd IJ penalty: $125,000
(100% of maximum IJ
penalty)
1st IJ penalty: $75,000
2nd IJ penalty: $100,000
3rd IJ penalty: $125,000
(100% of maximum IJ
penalty)
SEVERITY LEVEL 5
(Immediate jeopardy to
patient health or safety,
resulting in serious
injury)
1st IJ penalty: $45,000
2nd IJ penalty: $60,000
3rd IJ penalty: $75,000
(60% of maximum IJ penalty)
1st IJ penalty: $52,500
2nd IJ penalty: $70,000
3rd IJ penalty: $87,500
(70% of maximum IJ penalty)
1st IJ penalty: $60,000
2nd IJ penalty: $80,000
3rd IJ penalty: $100,000
(80% of maximum IJ
penalty)
SEVERITY LEVEL 4
(Immediate jeopardy to
patient health or safety,
likely to cause serious
injury or death)
1st IJ penalty: $30,000
2nd IJ penalty: $40,000
3rd IJ penalty: $50,000
(40% of maximum IJ penalty)
1st IJ penalty: $37,500
2nd IJ penalty: $50,000
3rd IJ penalty: $62,500
(50% of maximum IJ
penalty)
1st IJ penalty: $45,000
2nd IJ penalty: $60,000
3rd IJ penalty: $75,000
(60% of maximum IJ
penalty)
SEVERITY LEVEL 3
(Actual harm that is not
immediate jeopardy)
$15,000
(60% of $25,000)
$20,000
(80% of $25,000)
$25,000
(100% of $25,000)
SEVERITY LEVEL 2
(No actual harm; potential
for more than minimal
harm, not immediate
jeopardy)
$5,000
(20% of $25,000)
$12,500
(50% of $25,000)
$17,500
(70% of $25,000)
SEVERITY LEVEL 1
(No actual harm; potential
for no more than minimal
harm)
No Penalty No Penalty No Penalty
MINOR VIOLATION
No Penalty No Penalty No Penalty
Notes:
1 This chart applies to general acute care hospitals (including long term care hospitals (LTCHs) and inpatient rehabilitation facilities (IRFs)) as
well as acute psychiatric hospitals. The amount in each cell is the initial penalty; several adjustments will be made by CDPH to determine the final
penalty amount. See “Instructions for Calculating an Administrative Penalty” regarding the adjustments that CDPH may make.
2 “1st IJ penalty,” “2nd IJ penalty,” and “3rd IJ penalty” refer to how many penalties the hospital has received in the past. If a hospital goes 3
years without an IJ penalty, the next IJ penalty will be considered the first.
3 A small and rural hospital may request a payment plan and reduction of the penalty if payment would cause financial hardship.
APPENDIX HS-15
Federal vs. State Immediate Jeopardy Definition
and Implementation Comparison
(11/20)
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©CALIFORNIA HOSPITAL ASSOCIATION
State Federal
Immediate Jeopardy — A situation in which
the licensee’s noncompliance with one or
more requirements of licensure has caused,
or is likely to cause, seriuos injury or death
to the patient [Health & Safety Code Section
1280.1(c)]
Immediate Jeopardy — A situation in which
the provider’s noncompliance with one or more
requirements has caused, or is likely to cause,
seriuos injury, harm, impairment, or death to a
resident or patient [42 C.F.R. Section 489.3]
Components of an IJ:
▪ Noncompliance
▪ Actual or likely serious harm
▪ Need for immediate action
(SOM Appendix Q)
Upon recognizing a situation that may constitute
an IJ, the investigative process must proceed
until it confirms or rules out an IJ. The serious
harm, injury, impairment or death may have
occurred in the past, may be occurring at
present, or may be likely to occur in the
future as a result of the jeopardy situation.
(SOM Appendix Q)
Based on violation of a state requirement (Title
22 or the Health and Safety Code).
Based on violation of a federal requirement
Use “State IJ guidance for Evaluation to
Complete” for to detemine if IJ exists (state
surveyor tool).
Use “Federal Critical Path, Does IJ Exist” form
(from SOM Appendix Q)
Surveyor does not call an IJ on site, but has
a script to read to alert the hospital that the
surveyor may have identified an IJ.
Surveyor calls an IJ on site. Threat must be
present when surveyor is on-site. Otherwise, it is
called “past compliance.”
