Cabinet for Health and Family Services
Office of the Inspector General
Division of Health Care
Presents
OIG Hospital Survey and Process Review
By
Melanie Poynter, Assistant Director
Susan Moberly, RN, NCI
Goals of the training
Goal:
Provide information about the role of the OIG,
Division of Health Care.
Provide resources for hospitals concerning
state and federal regulations and processes.
Provide information on how a survey is
conducted.
Cabinet for Health and Family Services
Division of Health Care
Division of Health Care responsibilities:
Inspecting
Monitoring
Licensing and certifying
Investigating complaints
Facility plans review
Regulation development
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Cabinet for Health and Family Services
Division of Health Care Responsibilities
The regional branches of the Division of Health
Care are responsible for conducting on-site
visits of all health care facilities in the state to
determine compliance with applicable
licensing regulations and Medicare/Medicaid
certification requirements.
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OIG Branch County Coverage
Northern
Western Southern
Eastern
OIG/DHC Branch Offices
Western Branch
Kathy D. Perry, Regional Program Manager
Western State Hospital
P.O. Box 2200
2400 Russellville Road
Hopkinsville, KY 42241
Phone: 270-889-6052 Fax: 270-889-6089
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Northern Branch
Northern Branch
Belinda Beard, Regional Program Manager
L & N Building, 10-W 908 W. Broadway
Louisville, KY 40203
Phone: 502-595-4958 Fax: 502-595-4540
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Southern Branch
Southern Branch
Kim Brock, Regional Program Manager
116 Commerce Ave.
London, KY 40744
Phone: 606-330-2030 Fax: 606-330-2054
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Eastern Branch
Eastern Branch
Gae Vanlandingham, Regional Program
Manager
1055 Wellington Way, Suite 125
Lexington, KY 40513
Phone: 859-246-2301 Fax: 859-246-2307
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Why is OIG here?
• A long time ago, in a galaxy far, far, away…
• Hospitals obtained a Certificate of Need to
become a hospital.
• All Critical Access Hospitals were originally
licensed as an acute care hospital prior to
converting to a Critical Access Hospital.
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Why is OIG here?
• KRS 216B.042 Licenses — Authority to
enter upon premises — Authority for
administrative regulations.
The cabinet may authorize its agents or
representatives to enter upon the premises of
any health care facility for the purpose of
inspection, and under the conditions set forth in
administrative regulations promulgated under
KRS Chapter 13A by the cabinet.
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KRS 216B (cont’d)
Basically, KRS216B grants OIG the authority to
license, regulate and/or deny, modify or revoke
a license. It also grants OIG the authority to
enter the premises for the purposes of
inspection.
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902 KAR 20:008
902 KAR 20:008 Licensing procedures and fee
schedule is the administrative regulation that
sets the fee schedule, the initial and renewal
application process, the procedures of
inspection and issuing statements of
deficiencies, the plan of correction process, the
waiver and variance process as well as
adverse action procedures.
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902 KAR 20:008 (Cont’d)
In 2016, this regulation was amended to
include the provisional licensing process.
-Contains key definitions
-Grants OIG access to facilities and records
-Describes penalties may be imposed up to and
including modifying, suspending or revoking a
license for denying OIG access.
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902 KAR 20:008 (cont’d)
• Describes the process and timeframes for
issuing statements of deficiencies and plans
of correction.
• Describes the process of Adverse Action of a
licensee.
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OIG Role for Certification
• The Division of Health Care within the OIG is
also the state survey agency contracted by
the Centers for Medicare/Medicaid (AKA
CMS) to complete survey and certification
work under the 1864 agreement.
• When accessing medical records, not only
does OIG staff have authority to access
under KRS 216B, OIG/DHC is also exempt
from HIPPA as a federal oversight agency as
defined in §164.501(d) Cabinet for Health and Family Services
Types of Hospitals
• Several types of hospitals in KY and each
has a regulation describing the minimum
standards for operations and services as well
as a regulation for facility specifications.
• Acute Care hospital:
902 KAR 20:016-Operations and Services
902 KAR 20:009-Facility specifications
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Types of Hospitals (cont’d)
• Psychiatric hospitals:
902 KAR 20:180 –Operations and Services
902 KAR 20:170-Facility Specifications
• Comprehensive Rehabilitation Hospitals:
902 KAR 20:240-Operations and Services
902 KAR 20:230-Facility specifications
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Additional regulations
• Hospitals also comply with additional
regulations such as reporting information to the
Department for Public Health. For instance,
hospitals must comply with 902 KAR 20:205-
TB for Health Care workers, 902 KAR 2:020-
reportable disease and disease surveillance.
Hospitals also report information to DPH-
specifically to the Office of Vital Statistics on
Births, Deaths, and Fetal Deaths.
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DPH contacts
• TB Branch-
Maria Lasley or Emily Anderson 502-564-4276
Surveillance Branch-Emily Anderson
Office of Vital Statistics Branch- 502-564-4212
Christina Stewart, Branch Manager, ext 3200 or
Jeff Sparks ext 3210.
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OVS Reporting Requirements
Purposeful interruption of pregnancyAbortion
Fetal Death
“Live Birth” expulsion or extraction, breathes or shows any other evidence of life.Infant Death
Gestational weeks
20 weeks
Abortion Report Required
Stillbirth Certificate Required
Birth and Death Certificate
Required
Provisional Report of Death
Required
20 completed weeks or weighs 350 grams or more "Hospital Responsibility”. Death prior to the complete expulsion or extraction.
Fetal Death No Certificate RequiredLess than 20 weeks and or
weighs less than 350 grams.
KY-Child Application Required
KY-EDRS Application
RequiredProvisional Report of Death
Required
Provisional Report of Death Not
Required
ACCREDITATION ORGANIZATIONS (A0) AND
DEEMED STATUS
REGULATORY AUTHORITY: 42 CFR 488
Subpart A-General Provisions
488.1 Definitions
488.2 Statutory Basis
488.5 Application and Reapplication
488.8 Federal Review of AO’s
488.9 Validation Survey
ACCREDITATION ORGANIZATIONS (A0) AND
DEEMED STATUS
What is “Deemed Status”?
Providers or suppliers accredited by a CMS
approved national accreditation organization
(AO) are deemed to meet CMS conditions of
participation in the Medicare program. These
providers or suppliers are referred to as
“deemed status” providers or suppliers.
23
Approval of Accreditation Organizations
• A national accreditation organization applying for approval of deeming authority must provide CMS with reasonable assurance that the accreditation organization requires the accredited provider to meet requirements that are at least as stringent as the Medicare conditions.
• The regulations require AOs to reapply for continued approval of deeming authority every 6 years, or sooner as CMS determines.
• The application and reapplication process involves on-site observations, crosswalk comparability review and a comprehensive evaluation of the AO’s policies and procedures, standards and survey process and electronic data management.
ACCREDITATION ORGANIZATIONS (A0) AND
DEEMED STATUS
Deemed Status Providers/Suppliers
• Will lose “deemed status” when the State Agency cites a condition level deficiency during a complaint investigation and move under the jurisdiction of the SA until all condition level deficiencies are corrected.
• Sample Validation Surveys may also result in CMS removing deemed status.
Role of Accreditation
• Accreditation:
– Is voluntary
– Can substitute for on-going State Agency
review.
– Must be approved by CMS as meeting or
exceeding Medicare requirements.
Initial Certification Process
• Initial Certification of Hospital
Initial certification of a hospital can be attained two different ways:
1. Attain accreditation through a deeming organization. Joint Commission on Accreditation of Healthcare Organizations (JCAHO), The American Osteopathic Association (AOA), DNV GL-Healthcare (DNV), or American Association/Healthcare Facilities Accreditation Program (HFAP). The effective date of certification could not be earlier than the effective date of accreditation.
2. A full Medicare survey (including LSC) is conducted by the State Agency. Effective date of certification is the earlier of the following:
a. The date on which the provider meets all Conditions of Participation (CoPs) and no standard level deficiencies issued or,
b. If the provider is found to meet all CoPs but has standard level deficiencies , the date an acceptable plan of correction (PoC) is received is the effective date for certification regardless of when the SA approves the PoC.
(see section 2008 CMS State Operations manual and 42 CFR 489.13)Cabinet for Health and Family Services
Additional Requirements for Initial
Certification
• Appropriately licensed by the state;
• Approval of the CMS-855 by the provider’s
fiscal intermediary for initial enrollment;
• Submission of additional certification forms to
Central Office.
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Applicable Conditions of Participation (CoP)
• Acute Care Hospital– 42 CFR 482 Appendix A (A Tags)
• Acute Care Hospital with Swing Beds– 42 CFR 482 Appendix A (A Tags)
– 42 CFR 482.66 Appendix T
– 42 CFR 483 Selected sections as listed in Appendix T
• Critical Access Hospital (CAH) with or without Swing Beds, Psych Units, and/or Rehab Units
– 42 CFR 485 Appendix W
– 42 CFR 483 Selected sections as listed in Appendix W
• Psychiatric Hospital– 42 CFR 482 Appendix A (A Tags)
– 42 CFR 482.60, 61, 62 (2 Special Psychiatric Conditions) Appendix AA (B Tags)
*All appendices are subject to changes as specified in CMS Transmittals, Admin-Info Memos, and S&C (now known as QSO) documents. For example, S&C-04-48 updates Appendix W to include the CoPs for CAHs IPPS rehab and psych units
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Applicable CoP (cont’d)
• Psych Unit– 42 CFR 482 Appendix A (A Tags)
– 42 CFR 482.60, 61, 62 (2 Special Psychiatric Conditions) Appendix AA (B Tags)
• IPPS Psych Unit– 42 CFR 482 Appendix A (A Tags)
– 42 CFR 482.60, 61, 62 (2 Special Psychiatric Conditions) Appendix AA (B Tags)
– 42 CFR 412.25 and 412.27 – These are the IPPS exclusion criteria (not CoPs) and are on Form CMS-437 Psychiatric Unit Criteria Work Sheet
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Applicable CoP (Cont’d)
• Rehabilitation Hospital
– 42 CFR 482 Appendix A (A Tags)
• IPPS Rehabilitation Hospital
– 42 CFR 482 Appendix A (A Tags)
– 42 CFR 412.23 – This is the IPPS criterion (not
CoPs) and is on the Form CMS 437B
Rehabilitation Hospital Criteria Work Sheet
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Applicable CoP (cont’d)
• Rehabilitation Unit
– 42 CFR 482 Appendix A
• IPPS Rehabilitation Unit
– 42 CFR 482 Appendix A
– 42 CFR 412.25, 412.29, and 412.30 – These are
the IPPS criteria (not CoPs) and are on Form
CMS-437A Rehabilitation Unit Criteria Work
Sheet
Cabinet for Health and Family Services
Accreditation
How do you become an accredited hospital and what does that mean?
A hospital completes an application, pays fees, and is subjected to a complete survey by the accrediting organization. The hospital must meet the requirements of the accrediting organization in order to be approved for accreditation. Upon approval by the accrediting organization, the hospital must maintain compliance with the accrediting organizations requirements and may be subjected to surveys on a regular basis.
How does a hospital become deemed for certification?
CMS & Accreditation for Deemed Status
CMS requires accreditation organizations to demonstrate that their requirements meet or exceed the Medicare conditions if they want to be recognized as a deeming authority . Section 1861(e) and 1865(a) of the Act allows hospitals accredited by an approved national accrediting body to be “deemed” to meet Medicare Conditions of Participation.
CMS has approved deeming authority for the following accrediting organizations:
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP)
Center for Improvement for Healthcare Quality (CIHQ)
DNV GL-Healthcare (DNV GL)
***Deemed for certification means that a hospital meets the Federal CoPs***
***Please note hospitals must be accredited for their hospital type i.e. acute, critical access. A hospital who has recently changed from acute to critical access hospital must have the change in accreditation as well in order to be “deemed”.
***If a hospital is accredited by another accrediting organization that is not approved by CMS as having deemed authority, it would NOT be deemed for certification.
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Accreditation (cont’d)
• State Licensure and Accreditation (Deemed Status)
Effective July 15, 2002, KRS 216B.185 was established.
KRS 216B.185 (1)(a)(b) states:
The Office of the Inspector General shall accept accreditation by the Joint Commission on Accreditation of Healthcare Organizations or another nationally recognized accrediting organization with comparable standards and survey processes, that has been approved by the United States Centers on Medicare and Medicaid Services, as evidence that a hospital demonstrates compliance with all licensure requirements under this chapter. An annual on-site licensing inspection of a hospital shall not be conducted if the Office of the Inspector General receives from the hospital:
(a) A copy of the accreditation report within thirty (30) days of the initial
accreditation and all subsequent reports; or
(b) Documentation from a hospital that holds full accreditation from an approved accrediting organization on or before July 15, 2002.
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Accreditation (cont’d)
• State Licensure and Accreditation (Deemed Status) (cont’d)
Therefore a hospital that is deemed for certification is also deemed for licensure and a routine relicensure survey would never be conducted unless deemed status is removed.
However, licensure complaint investigations shall be conducted as necessary. Licensure validation surveys shall also be conducted as defined in 906 KAR 1:140.
Annual relicensure surveys shall be conducted on non-deemed hospitals.
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END of MP’s portion
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Enforcement Process/Adverse Actions
Remember earlier when we discussed Deemed
Status? It will come into play when complaints
are investigated and at any time Condition
Level deficiencies are cited.
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NUMBERS
– 88% of hospitals nationally have deemed
status. State Agencies (SAs) may only perform
CMS validation surveys at CMS Regional Office
(RO) direction
– Representative sample – small number
– Substantial allegation – complaint
• >80% of all SA Federal hospital surveys are
complaint surveys >3,300 surveys nationally
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CAH’s
• Very different situation from hospitals:
• 32% of CAHs have deemed status
• Federal surveys roughly divided equally
between standard and complaint surveys
• Nationally < 3% of CAHs have a complaint
survey each year
• CAHs have different CoPs
• But the general principles of complaint
investigations apply as well to CAHs
Cabinet for Health and Family Services
Complaint numbers
• Nationally about 25% of all hospitals have a
Federal complaint survey each year
• In Kentucky, the average amount of
complaints received on all hospital types that
require an onsite investigation= @ 150-200
per year.
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Hospital Complaints
Since most of Kentucky’s hospitals have
deemed status, the majority of surveys are
initiated based on complaint allegations.
OIG/DHC also receives complaints that do not
require an on-site investigation and refers those
complainants to the applicable accrediting
organization.
Cabinet for Health and Family Services
Hospital Complaints (Cont’d)
• Although OIG has the authority to investigate
complaint allegations under state licensing
regulations on all hospitals, prior to
investigation for complaints on deemed
hospitals, the state agency (OIG) obtains a
2802 from CMS.
• OIG surveyors then initiate the investigation
in the form of a survey.
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Investigating Complaint in
Deemed/Non-Deemed Facilities
Complaint Investigation Findings/Scenarios:
1. Standard level deficiencies or no deficiencies
are cited during complaint investigation
2. Condition-level deficiency non-IJ cited during
complaint investigation
3. Condition-level deficiency IJ cited during
complaint investigation 44
Certification re-survey or Complaint survey findings in
Deemed/Non-Deemed Facilities
1. Standard level deficiencies or no deficiencies
are cited from survey or complaint
investigation
• Deemed: Facility is in substantial
compliance. SA sends SOD but does not
request POC. (An exception can be made for
LSC.)
• Non-Deemed: SA sends SOD and requests
POC for standard level deficiencies.
45
Investigating Complaint in
Deemed/Non-Deemed Facilities
2. Condition-level deficiency non-IJ cited
during complaint investigation
Deemed Facilities:
• 90 day termination does not begin at this
time
• SA sends courtesy notice to the hospital;
RO sends SOD; can request a POC; advises
facility that SA may conduct full certification
survey--deemed status is removed.
46
Non-Deemed Hsp:COP out (non-IJ)
• SA sends SOD and requests POC and initiates 90
day termination process. SA can conduct 1 revisit
by 45th day. If compliance is not achieved by 45th
day, SA sends courtesy notice and notifies RO by
55th day.
• RO takes over enforcement after 55th day and will
direct SA if 2nd revisit is required. Termination by
90th day if compliance is not achieved
(CMS State operations Manual, 3012, Chapter 5)47
Investigating Complaint in
Deemed/Non-Deemed Facilities
3. Condition-level deficiency IJ cited during
complaint investigation
Deemed and Non-Deemed Facilities:
• RO takes over enforcement whenever an IJ is
cited.
• SA sends courtesy notice to the hospital by
2nd working day; RO sends SOD and starts
23 day termination.
(CMS State operations Manual, 3010, Chapter 5)
48
3. Condition-level deficiency IJ cited during
complaint investigation (cont’d)
Deemed and Non-Deemed Facilities:
• If acceptable POC is received, SA will
conduct revisit to determine if IJ is removed.
• Deemed Facilities: Full cert survey may also
be required if directed by CMS.
Also, if the COP will remains out of compliance
on the revisit, the CMS RO may convert to 90
day termination.49
Investigating Complaint in
Deemed/Non-Deemed Facilities
Recertification Surveys
2. Condition-level deficiency non-IJ cited
during recertification survey
• If COP is out during recert survey, the 90 day
termination process begins.
• SA sends SOD/requests POC and places
facility on 90 day termination track.
• SA will conduct 1 revisit by 45th day if
acceptable POC is received. If compliance is
not achieved by 45th day, SA sends courtesy
SOD and refers to RO by 55th day.50
Recertification Surveys
2. Condition-level deficiency non-IJ cited during
recertification survey of a Non-Deemed hsp.
• RO sends SOD and requests POC.
• SA will be requested to conduct 2nd revisit if
acceptable POC is received.
• If compliance is not achieved by 90th day,
facility is terminated from the Medicare
program.
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EMTALA
Medicare participating hospitals must meet the
Emergency Medical Treatment and Labor Act
(EMTALA) requirements codified at §1866
§1867 of the Social Security Act and
accompanying regulations in 42 CFR §489.24
and 42 CFR 489.20 (l), (m), (q), and (r).
52
EMTALA
EMTALA requires hospitals with emergency
departments to:
• Provide medical screening exams to any
individual who comes to the ED and requests
an examination or treatment; and
• Provide necessary stabilizing treatment or
appropriate transfer for those with emergency
medical conditions.
• EMTALA requirements also include the
recipient hospital responsibilities.53
EMTALA
• OIG receives an average of 10-15 EMTALA
allegations for investigation each year.
• EMTALA violations also have civil monetary
penalties assessed by CMS. They can be
assessed to hospitals as well as individual
physicians.
• Once the SA completes investigation, the
findings are transmitted to the RO.
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EMTALA
• If the RO determines no violation, the RO
notifies the facility via letter.
• If the RO determines a violation, the RO will
notify facility when they are placed on a 23 or
90 day termination—beginning with the date
of the notice. RO will request a POC from the
hospital.
• RO will request SA to do revisit to determine
compliance prior to the termination date.
55
Most Common Deficiencies
• KY’s most commonly cited Condition-Level
deficiencies:
• Nursing Services
• Patient Rights
• Governing Body
• QAPI (Quality Assessment & Performance
Improvement
• Emergency Services
• Surgical ServicesCabinet for Health and Family Services
Immediate Jeopardy
Cabinet for Health and Family Services
• In March 2019, CMS updated Appendix Q of
the State Operations Manual in a QSO
Memorandum to State Survey Agencies
(QSO-19-09-ALL)
• Identified a Core Appendix Q for all provider
types with Subparts for specific provider
types such as nursing homes and
laboratories.
Immediate Jeopardy
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• The memo also clarified the Key Components
of Immediate Jeopardy
• Introduced the IJ template that surveyors
utilize to determine IJ as well as
communicate each component to convey
information to the surveyed entity.
Immediate Jeopardy- Definition
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IJ Components
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IJ Template
• Survey teams must use the Immediate
Jeopardy (IJ) Template to document evidence
of each component of IJ; and if IJ is confirmed,
the IJ Template will be used to convey
information to the entity. Any information
presented on this template is subject to change
and does not reflect an official finding against a
Medicare provider or supplier. Form CMS-
2567 is the only form that contains official
survey findings.
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IJ Template
Cabinet for Health and Family Services
Definitions
• Likely/Likelihood 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
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Definitions (Cont’d)
• Noncompliance means failure to meet one
or more federal health, safety, and/or quality
regulations.
• Recipient at Risk is a recipient who, as a
result of noncompliance, and in consideration
of the recipient’s physical, mental,
psychosocial or health needs, and/or
vulnerabilities, is likely to experience a serious
adverse outcome. Cabinet for Health and Family Services
Definitions (Cont’d)
• Serious injury, serious harm, serious
impairment or death are adverse outcomes
which result in, or are likely to result in:
• death; or
• a significant decline in physical, mental, or
psychosocial functioning, (that is not solely
due to the normal progression of a disease or
aging process); or
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Definitions (Cont’d)
• loss of limb, or disfigurement; or
• avoidable pain that is excruciating, and more
than transient; or other serious harm that
creates life-threatening
complications/conditions.
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IJ (Cont’d)
• *NOTE: IJ does not require serious injury,
harm, impairment or death to occur. It is
sufficient that non-compliance makes
serious injury, harm, impairment or death
likely to occur to one or more recipients.
• Disclaimer: The findings on the IJ Template
are preliminary and do not represent an official
finding against a Medicare provider or supplier.
Form CMS-2567 is the only form that contains
official survey findings. Cabinet for Health and Family Services
Key Takeaways
• Timeframes are accelerated when
Immediate Jeopardy is present.
• Each situation is unique.
• CMS interpretive guidelines are helpful but
are not regulation.
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RESOURCES
• OIG Division of Health Care webpage:
https://chfs.ky.gov/agencies/os/oig/dhc/Pages/d
efault.aspx
• CMS State Operations Manual link:
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Internet-Only-
Manuals-IOMs-Items/CMS1201984.html
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Resources
• OIG Directories & links to common hospital state
regulations:
https://chfs.ky.gov/agencies/os/oig/dhc/Pages/hcf.asp
x
• CMS Appendix A-Federal CoP’s including CMS
interpretive guidelines:
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap
_a_hospitals.pdf
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Resources
• CMS SOM Appendix V-EMTALA including
CMS interpretive guidelines:
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som1
07ap_v_emerg.pdf
• CMS SOM Appendix W-Federal CoP’s
including CMS interpretive guidelines:
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som1
07ap_w_cah.pdf Cabinet for Health and Family Services
Resources
• CMS SOM Appendix AA-Psychiatric Hospital
CoP’s including CMS interpretive guidelines:
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som1
07ap_aa_psyc_hospitals.pdf
• CMS SOM Appendix Q-Guidelines for
Determining Immediate Jeopardy:
https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som1
07ap_q_immedjeopardy.pdfCabinet for Health and Family Services
Resources
QSOG Policy memo’s to States and Regions:
https://www.cms.gov/Medicare/Provider-
Enrollment-and-
Certification/SurveyCertificationGenInfo/Policy-
and-Memos-to-States-and-Regions.html
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Conclusion