Accreditation and Certification. Dorothy Dupree, Acting Director Margaret Brady, Quality Management Phoenix Area

Accreditation and Certification Dorothy Dupree, Acting Director Margaret Brady, Quality Management Phoenix Area 1

QUALITY PROCESS PYRAMID 2

Base Level 3

Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights Quality Assessment Performance Improvement Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 4

Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 5

Level Two Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 6

Accreditation Pyramid Level Two Hospital Accreditation Organizations: The Joint Commission The American Osteopathic Association Health Facilities Accreditation Program (HFAP) Det Norske Veritas Health Care (DNV) 7

Accreditation Hospital Accreditation Organizations: The Joint Commission The American Osteopathic Association Health Facilities Accreditation Program (HFAP) Det Norske Veritas Health Care (DNV) Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 8

Level Three Accreditation Hospital Accreditation Organizations: The Joint Commission Governing Body The American Osteopathic Association Health Facilities Accreditation Program (HFAP) Det Norske Veritas Health Care (DNV) Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 9

Level Three Governing Board Legally responsible for the conduct of the hospital Must carry out functions specified: Medical staff CEO Care of Patients Institutional Plan and Budget Contracted Emergency 10

Governing Board Accreditation Hospital Accreditation Organizations: The Joint Commission Governing Body The American Osteopathic Association Health Facilities Accreditation Program (HFAP) Det Norske Veritas Health Care (DNV) Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 11

A little more on Governing Board The Governing Board must ensure that the program reflects the complexity of the hospital s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on DATA indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI)program. The process must be proactive Focused on care to patients Focused on the performance of the hospital as an organization Focused on the impact of treatment furnished by hospital on the health status of patients EMPHASIS ON PATIENT SAFETY AND ACCOUNTABILITY The hospital must maintain and demonstrate evidence of it s QAPI program for review by Accrediting Body and CMS 12

Governing Body Assessment & Action Taken Action Summary Reports Medical Peer Review Medical Plan of Care Quality Council Medial Staff Medical Executive Committee CoP QAPI Reports (See following slide # 14) 13

QAPI Integration at the Quality Council Anesthesia Blood Transfusion Contracted Dietary Discharge Planning Emergency Facilities Grievance Process Lab Medication Administration Medication errors Nursing Outpatient PT Radiological Organ, Tissue and Eye Donation Pharmacy Respiratory Restraint & Seclusion Routine and Preventive Maintenance Testing Activities Safety and Security Infection Control Surgical Performance Improvement Activities Measurement Indicators 14

Bumps in the Road to QAPI Integration Role of the Quality Manager Line of Authority Training Standardization Process of Change Protecting your Turf Resourcing the Program at the Area and Service Unit Medical Plan 15

Governing Board Accreditation Hospital Accrediting Bodies: The Joint Commission Governing Body The American Osteopathic Association Health Facilities Accreditation Program (HFAP) Det Norske Veritas Health Care (DNV) Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative Respiratory 16

Governing Board Accreditation Hospital Accrediting Bodies: The Joint Commission Governing Body The American Osteopathic Association Health Facilities Accreditation Program (HFAP) Det Norske Veritas Health Care (DNV) Medicare Conditions of Participation Compliance with Law Governing Body Patient s Rights QAPI Medical Staff Nursing Medical Records Pharmaceutical Radiologic Laboratory Food & Dietetic Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue & Eye Procurement Surgical Anesthesia Nuclear Medicine Outpatient Emergency Rehabilitative TRIBAL CONSULTATION COMMUNITY NEEDS Respiratory 17

More on Medicare CoPs 18

Quality Assessment Performance Improvement 482.21 Radiologic 482.26 Infection Control 482.42 Nuclear Medicine 482.53 Medicare Conditions of Participation Compliance with Law 482.11 Medical Staff 482.22 Laboratory 482.27 Discharge Planning 482.43 Outpatient 482.54 Governing Body 482.12 Nursing 482.23 Food & Dietetic 482.28 Organ, Tissue & Eye Procurement 482.45 Emergency 482.55 Patient s Rights 482.13 Medical Records 482.24 Utilization Review 482.30 Surgical 482.51 Rehabilitative 482.56 Pharmaceutical 482.25 Physical Environment 482.41 Anesthesia 482.52 Respiratory 482.57 19

Medicare Conditions of Participation (CoPs) General Provisions Administration Basic Hospital Functions Optional Hospital Requirements for Specialty Hospitals 20

CoPs General Provisions Basis and Scope (482.1) 1861(e) Statutory Basis Hospitals participating in Medicare must meet certain specified requirements Hospitals participating in Medicare and Medicaid must have a Utilization Review Plan Hospitals receiving Medicaid must meet requirements for Medicare participation (except in medical supervision of nurse-midwife services (subsection 440.10 & 440.165) Emergency (484.2) Institutions with no Medicare agreement may be reimbursed for emergency services (per section 424) 21

CoPs Administration (482.11) Compliance federal, state and local regulations Licensing Personnel licensing 22

CoPs Governing Body (482.12) Legally responsible for the conduct of the hospital Must carry out functions specified: Medical Staff CEO Care of Patients Institutional Plan and Budget Contracted Emergency 23

CoPs Patient Rights (482.13) Notice of Rights Exercise of Rights Privacy and Safety Confidentiality of Patient Records Restraint or Seclusion Staff Training Requirements Death Reporting Requirements 24

CoPs Quality Assessment & Performance Improvement Plan (482.21) Hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and improvement plan Scope Program Data Program Activities Projects Executive Responsibilities 25

CoPs Medical Staff (482.22) Composition Organization and Accountability Staff Bylaws Autopsies 26

CoPs Nursing (482.23) Organization Staffing and Delivery of Care Preparation and Administration of Drugs 27

CoPs Medical Record (482.24) Organization and Staffing Form and Retention of Records Content of Records 28

Other CoPs 482.25 Pharmaceutical 482.26 Radiologic 482.27 Lab 482.28 Food and Dietetic 482.30 Utilization Review 482.41 Physical Environment 482.42 Infection Control 482.43 Discharge Planning 482.45 Organ, Tissue and Eye Procurement 29

Optional Hospital (subpart D) 482.51 Surgical 482.52 Anesthesia 482.53 Nuclear Medicine 482.54 Outpatient 482.55 Emergency 482.56 Rehabilitation 482.57 Respiratory Care 30

Requirements for Specialty Hospitals (subpart E) Psychiatric Hospitals Long Term Care Swing Beds Transplant Centers Notification to CMS Data submission, clinical experience & outcome requirements Process requirements 31

Questions at this Point 32

Certification verses Accreditation 33

Focus of this Section Basics of a CMS Survey Basics of EMTALA 34

CMS CMS Centers for Medicare & Medicaid (Formerly HCFA) Health Care Financing Administration Brother/sister Agency in the Department of Health and Human CMS authority comes from federal law they are regulatory in focus A facility can t participate in the Medicare & Medicaid programs (meaning bill for services) unless CMS certifies the facility 35

Indian Health System What does this have to do with us Just like everyone else, facilities within the Indian Health System must be certified by CMS to participate in Medicare & Medicaid 36

Certification for Medicare Participation CMS Centers for Medicare & Medicaid Only CMS can certify a facility for Medicare Participation CMS certification to participate in Medicare means the facility is now eligible to receive payment for services to Medicare beneficiaries In order to receive Medicaid a facility must meet the requirements to participate in Medicare 37

Certification for Medicare Participation In order to participate in Medicare, a facility must meet all Federal Requirements Civil Rights: Attestation Enrollment: Form CMS-855 Conditions of Participation (CoP): Survey Conditions of Participation (CoPs) are what CMS expects a facility, meaning its leaders and staff, to do to protect the health and safety of Medicare beneficiaries 38

Accreditation CMS certifies facilities for participation in Medicare CMS does not accredit facilities Accrediting Organizations accredit facilities Accreditation is a business decision for private sector facilities An IHS Policy for Federal facilities Accreditation Accreditation with deemed status Deemed status constitutes a determination that the entire facility meets or exceeds the CoPs 39

Accrediting Organizations For Hospitals and Critical Access Hospitals CMS has approved three (3) Accrediting Organizations The Joint Commission - TJC Det Norske Veritas Health Care DNVHC also called DNV American Osteopathic Association - AOA 40

Accredited & Deemed are Different A facility can choose to be Accredited Meaning the facility is in compliance with the Accreditation Standards of the Accrediting Organization Example AAAHC s Accreditation of an Ambulatory Clinic A facility can choose to be Accredited with deemed status Meaning CMS has deemed that the Accrediting Organization s determination of compliance with Accreditation Standards is accepted by CMS as meeting the Conditions of Participation Example The Joint Commission Accreditation s of a Hospital 41

Removal of Deemed Status If CMS determines that an accredited with deemed status facility is out of compliance with a CoP CMS will remove deemed status The facility remains accredited and subject to the requirements of the Accrediting Organization However deemed status has been removed and the facility is subject to direct CMS authority 42

Return of Deemed Status Deemed status will not be returned until an onsite survey determines that the CoPs are in compliance 43

Example CMS Surveys a facility accredited with deemed status by The Joint Commission CMS Finding not in compliance with Conditions of Participation CMS removes deemed status CMS requires a corrective action plan 44

Example (cont.) The accrediting organization The Joint Commission is notified that deemed status has been removed The Joint Commission surveys the facility The facility is still accredited by The Joint Commission The Joint Commission finds non-compliance with their standards The Joint Commission requires a report from the facility with evidence of standards compliance 45

Example (cont.) The facility has two requirements Plan of Correction for CMS Evidence of Standards Compliance and Measure of Success for The Joint Commission 46

Example (cont.) If all goes well The facility implements a successful Plan of Correction CMS resurveys the facility and finds it is now in compliance with the Conditions of Participation CMS certifies the facility for participation in the Medicare & Medicaid programs 47

Example (cont.) If all goes well The Joint Commission accepts the facilities Evidence of Standards Compliance and Measure of Success The Joint Commission resurveys the facility and finds they meet the Accreditation Standards Deemed status is returned after CMS Certification 48

Termination CMS termination does not close a facility CMS termination terminates the Medicare & Medicaid provider agreements, thus stopping all Medicare & Medicaid payment 49

Why is a Facility Terminated from the It does not go well Medicare Program? A facility does not implement an effective Plan of Correction demonstrating compliance with Conditions of Participation CMS will give a facility more then one opportunity to demonstrate compliance CMS will write a Plan of Correction for a facility sounds nice you don t want this 50

Why is a Facility Terminated from the Medicare Program? (cont.) It does not go well A facility refuses to allow a CMS survey A facility interferes with a CMS survey A facility refuses to provide requested information A facility refuses to allow photocopying 51

How does a Facility Get a CMS Survey? The facility is not accredited therefore CMS conducts regular, though not frequent, surveys Every 4 6 years or they can come back anytime 52

How does a Facility Get a CMS Survey? (cont.) A facility is Accredited with deemed status and CMS decides to do a validation survey They are validating the findings of the Accrediting Organization Random selection 53

How does a Facility Get a CMS Survey (cont.) A Complaint Allegation is received by CMS A complaint is an allegation of noncompliance with Federal requirements An allegation is an assertion of improper care or treatment that could result in the citation of a CMS deficiency A substantial allegation of noncompliance is a complaint that if substantiated would affect the health & safety of individuals & raise doubts as to the facility s compliance with CoPs 54

How does a Facility Get a CMS Survey? (cont.) An Immediate Jeopardy (IJ) Noncompliance has caused or is likely to cause serious injury, harm, impairment, or death Restraint/seclusion death report Emergency Medical Treatment & Active Labor Act (EMTALA) 55

EMTALA Required by Law Compliance with Policies and Procedures Sign Posting Emergency Room Log Appropriate Medical screening Exam Stabilizing Treatment Appropriate Transfer 56

Example OB patient Referred to an OB/GYN Physician for prenatal care Patient came to a facility s Emergency Room in Early Labor Consultation with the patient s OB/GYN Physician Physician asked that the patient be transferred to the local hospital 57

Example (cont.) Local Hospital filed an EMTALA violation complaint with CMS The Local Hospital stated that the physician was not acting on behalf of the hospital the physician was not on call for the Local Hospital The facility should have contacted the hospital to accept the transfer 58

Example (cont.) This specific IHS facility has had two CMS EMTALA Surveys Each Survey finds something new requiring a Plan of Correction 59

Topics Covered to this Point Quality Process Pyramid Medicare CoPs Accreditation Governing Board QAPI Quality Council Medical Staff/Medical Executive Committee Bumps in the Road Tribal Consultation More on CoPs CMS Accreditation vs Certification vs deemed Termination EMTALA 60

Looking for Audience Input Building a Toolkit 61

Tool Kit Topic Examples Governing Body Standardized Governing Body By-laws Based on The Joint Commission Leadership Standards Cross-reference to the CoPs Orientation Program for the Governing Body Standardized Agenda Network-wide policies & procedures specific to CoPs 62

Tool Kit Topic Examples (cont.) Quality Managers on site Job description and PMAP with clear authority and expectations Training on the CoPs CoPs cross-walked to the Accreditation Standards Network support Webinar and face-to-face meetings 63

Useful Websites Interpretive Guidelines www.cms.hhs.gov/manuals/downloads/som107_appendixtoc.pdf Survey and Certification Letters www.cms.hhs.gov/surveycertificationgeninfor/pmsr/list.asp CMS Home Page www.cms.hhs.gov CMS Survey and Certification Home Page www.cms.hhs.gov/surveycertificationgeninfor Electronic CFR (e-cfr) http://ecfr.gpoaccess.gov Social Security Act http://www.ssa.gov/op_home/ssact-toc.htm 64