CMS Manual System

1 CMS Manual System Department of Health & Human Services (DHHS) Pub. 100-07 State Operations Provider Certification Centers for Medicare & Medicaid Services (CMS)Transmittal 37 Date: October 17, 2008 SUBJECT: Revise Appendix A, Interpretive Guidelines for Hospitals I. SUMMARY OF CHANGES: Appendix A is being revised to reflect amended regulations and survey and certification policy issuances concerning the Conditions of Participation for Hospitals, 42 CFR Part 482. It also contains new guidance related to the Patients' Rights Final Rule, 42 CFR (e), (f), and (g), published in the Federal Register December 8, 2006 (71 FR 71378). In addition, Regulatory text that appears in brackets was included in a previous tag, but is repeated for clarity and accuracy in representing the regulatory citation. NEW/REVISED MATERIAL - EFFECTIVE DATE*: Upon Issuance IMPLEMENTATION DATE: Upon Issuance Disclaimer for Manual changes only: The revision date and transmittal number apply to the red italicized material only.

2 Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents. II. CHANGES IN Manual INSTRUCTIONS: (N/A if Manual not updated.) (R = REVISED, N = NEW, D = DELETED) (Only One Per Row.) R/N/D CHAPTER/SECTION/SUBSECTION/TITLE R Appendix A Table of Contents R Appendix A/ of Participation: Patient s Rights R Appendix A/ (e)/Restraint or Seclusion R Appendix A/ (f)/Standard: Restraint or Seclusion: Staff Training Requirements N Appendix A/ (g)/Standard: Death Reporting Requirements R Appendix A/ (a)/Standard: Radiologic Services R Appendix A/ (a)/Standard: Adequacy of Laboratory Services R Appendix A/ (b)/Standard: Potentially Infectious Blood and Blood Components N Appendix A/ (c)/Standard: General Blood Safety Issues R Appendix A/ (c)/Standard: State Exemption R Appendix A/ of Participation: Respiratory Care Services R Appendix A/ of Participation.

3 Compliance With Federal, State and Local Laws R Appendix A/ (a) R Appendix A/ (b) R Appendix A/ (c) R Appendix A/ of Participation: Governing Body R Appendix A/ (a)/Standard: Medical Staff R Appendix A/ (b)/Standard: Chief Executive Officer R Appendix A/ (c)/Standard: Care of Patients R Appendix A/ (d)/Standard: Institutional Plan and Budget R Appendix A/ (e)/Standard: Contracted Services R Appendix A/ (f)/Standard: Emergency Services R Appendix A/ of Participation: Patient s Rights R Appendix A/ (a)/Standard: Notice of Rights R Appendix A/ (b)/Standard: Exercise of Rights R Appendix A/ (c)/Standard: Privacy and Safety R Appendix A/ (d)/Standard: Confidentiality of Patient Records R Appendix A/ (e)/Standard: Restraint or Seclusion R Appendix A/ (f)/Standard: Restraint or Seclusion: Staff Training Requirements N Appendix A/ (g)/Standard: Death Reporting Requirements R Appendix A/ of Participation: Quality Assessment and Performance Improvement Program R Appendix A/ (a)/Standard: Program Scope R Appendix A/ (b)/Standard: Program Data R Appendix A/ (c)/Standard: Program Activities R Appendix A/ (d)/Standard: Performance Improvement Projects R Appendix A/ (e)/Standard: Executive Responsibilities R Appendix A/ of Participation: Medical staff R Appendix A/ (a)/Standard: Composition of the Medical Staff R Appendix A/ (b)/Standard: Medical Staff Organization and Accountability R Appendix A/ (c)/Standard: Medical Staff Bylaws R Appendix (d)/Standard: Autopsies R Appendix A/ of Participation: Nursing Services R Appendix A/ (a)/Standard.

4 Organization R Appendix A/ (b)/Standard: Staffing and Delivery of Care R Appendix A/ (c)/Standard: Preparation and Administration of Drugs R Appendix A/ of Participation: Medical Record Services R Appendix A/ (a)/Standard: Organization and Staffing R Appendix A/ (b)/Standard: Form and Retention of Record R Appendix A/ (c)/Standard: Content of Record R Appendix A/ of Participation: Pharmaceutical Services R Appendix A/ (a)/Standard: Pharmacy Management and Administration R Appendix A/ (b)/Standard: Delivery of Services R Appendix A/ of Participation: Radiologic Services R Appendix A/ (a)/Standard: Radiologic Services R Appendix A/ (b)/Standard: Safety for Patients and Personnel R Appendix A/ of Participation: Laboratory Services R Appendix A/ (a)/Standard: Adequacy of Laboratory Services R Appendix A/ (b)/Standard: Potentially Infectious Blood and Blood Components N Appendix A/ (c)/Standard: General Blood Safety Issues R Appendix A/ of Participation: Food and Dietetic Services R Appendix A/ (a)/Standard: Organization R Appendix A/ (b)/Standard: Diets R Appendix A/ of Participation: Utilization Review R Appendix A/ (a)/Standard: Applicability R Appendix A/ (b)/Standard: Composition of Utilization Review Committee R Appendix A/ (c)/Standard: Scope and Frequency of Review R Appendix A/ (d)/Standard: Determination Regarding Admissions or Continued Stays R Appendix A/ (e)/Standard: Extended Stay Review R Appendix A/ (f)/Standard: Review of Professional Services R Appendix A/ of Participation: Physical Environment R Appendix A/ (a)/Standard: Buildings R Appendix A/ (b)/Standard: Life Safety From Fire R Appendix A/ (c)/Standard: Facilities R Appendix A/ of Participation.

5 Infection Control R Appendix A/ (a)/Standard: Organization and Policies R Appendix A/ (b)/Standard: Responsibilities of Chief Executive Officer, Medical Staff, and Director of Nursing Services R Appendix A/ /Condition of Participation: Discharge Planning R Appendix A/ (a)/Standard: Identification of Patients in Need of Discharge Planning R Appendix A/ (b)/Standard: Discharge Planning Evaluation R Appendix A/ (c)/Standard: Discharge Plan R Appendix A/ (d)/Standard: Transfer or Referral R Appendix A/ (e)/Standard: Reassessment R Appendix A/ of Participation: Organ, Tissue, and Eye Procurement R Appendix A/ (a)/Standard: Organ Procurement Responsibilities R Appendix A/ (b)/Standard: organ transplantation Responsibilities R Appendix A/ of Participation: Surgical Services R Appendix A/ (a)/Standard: Organization and Staffing R Appendix A/ of Participation: Anesthesia Services R Appendix A/ (a)/Standard: Organization and Staffing R Appendix A/ (b)/Standard: Delivery of Services R Appendix A/ of Participation: Rehabilitation Services R Appendix A/ (a)/Standard: Organization and Staffing R Appendix A/ (b)/Standard: Delivery of Services R Appendix A/ of Participation: Respiratory Care Services R Appendix A/ (a)/Standard: Organization and Staffing R Appendix A/ (b)/Standard: Delivery of Services III.

6 FUNDING: No additional funding will be provided by CMS; contractor activities are to be carried out within their operating budgets. IV. ATTACHMENTS: Business Requirements X Manual Instruction Confidential Requirements One-Time Notification Recurring Update Notification *Unless otherwise specified, the effective date is the date of service. State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals Table of Contents (Rev. 37, I0-17-08) Survey Protocol Introduction Task 1 - Off-Site Survey Preparation Task 2 - Entrance Activities Task 3 - Information Gathering/Investigation Task 4 - Preliminary Decision Making and Analysis of Findings Task 5 - Exit Conference Task 6 Post-Survey Activities Psychiatric Hospital Survey Module Psychiatric Unit Survey Module Rehabilitation Hospital Survey Module Inpatient Rehabilitation Unit Survey Module Hospital Swing-Bed Survey Module Regulations and Interpretive Guidelines Provision of Emergency Services by Nonparticipating Hospitals Condition of Participation: Compliance with Federal, State and Local Laws Condition of Participation: Governing Body (a) Standard: Medical Staff (b) Standard: Chief Executive Officer (c) Standard: Care of Patients (d) Standard: Institutional Plan and Budget (e) Standard: Contracted Services (f) Standard: Emergency Services Condition of Participation.

7 Patient's Rights (a) Standard: Notice of Rights (b) Standard: Exercise of Rights (c) Standard: Privacy and Safety (d) Standard: Confidentiality of Patient Records (e) Standard: Restraint or Seclusion (f) Standard: Restraint or Seclusion: Staff Training Requirements (g) Standard: Death Reporting Requirements Condition of Participation: Quality Assessment and Performance Improvement Program (a) Standard: Program Scope (b) Standard: Program Data (c) Standard: Program Activities (d) Standard: Performance Improvement Projects (e) Standard: Executive Responsibilities Condition of Participation: Medical staff (a) Standard: Composition of the Medical Staff (b) Standard: Medical Staff Organization and Accountability (c) Standard: Medical Staff Bylaws (d) Standard: Autopsies Condition of Participation: Nursing Services (a) Standard: Organization (b) Standard: Staffing and Delivery of Care (c) Standard: Preparation and Administration of Drugs Condition of Participation: Medical Record Services (a) Standard: Organization and Staffing (b) Standard: Form and Retention of Record (c) Standard: Content of Record Condition of Participation: Pharmaceutical Services (a) Standard: Pharmacy Management and Administration (b) Standard: Delivery of Services Condition of Participation: Radiologic Services (a) Standard: Radiologic Services (b) Standard: Safety for Patients and Personnel (c) Standard: Personnel (d) Standard: Records Condition of Participation: Laboratory Services (a) Standard: Adequacy of Laboratory Services (b) Standard: Potentially Infectious Blood and Blood Components (c) Standard: General Blood Safety Issues Condition of Participation: Food and Dietetic Services (a) Standard: Organization (b) Standard: Diets Condition of Participation: Utilization Review (a) Standard.

8 Applicability (b) Standard: Composition of Utilization Review Committee (c) Standard: Scope and Frequency of Review (d) Standard: Determination Regarding Admissions or Continued Stays (e) Standard: Extended Stay Review (f) Standard: Review of Professional Services Condition of Participation: Physical Environment (a) Standard: Buildings (b) Standard: Life Safety from Fire (c) Standard: Facilities Condition of Participation: Infection Control (a) Standard: Organization and Policies (b) Standard: Responsibilities of Chief Executive Officer, Medical Staff, and Director of Nursing Services Condition of Participation: Discharge Planning (a) Standard: Identification of Patients in Need of Discharge Planning (b) Standard: Discharge Planning Evaluation (c) Standard: Discharge Plan (d) Standard: Transfer or Referral (e) Standard: Reassessment Condition of Participation: Organ, Tissue and Eye Procurement (a) Standard: Organ Procurement Responsibilities (b) Standard: organ transplantation Responsibilities Condition of Participation: Surgical Services (a) Standard: Organization and Staffing (b) Standard: Delivery of Service Condition of Participation: Anesthesia Services (a) Standard: Organization and Staffing (b) Standard: Delivery of Services (c) Standard: State Exemption Condition of Participation: Nuclear Medicine Services (a) Standard: Organization and Staffing (b) Standard: Delivery of Service (c) Standard: Facilities (d) Standard: Records Condition of Participation: Outpatient Services (a) Standard: Organization (b) Standard: Personnel Condition of Participation: Emergency Services (a) Standard: Organization and Direction (b) Standard: Personnel Condition of Participation: Rehabilitation Services (a) Standard: Organization and Staffing (b) Standard.

9 Delivery of Services Condition of Participation: Respiratory Services (a) Standard: Organization and Staffing (b) Standard: Delivery of Services Survey Protocol Introduction (Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08) Hospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid payment. The goal of a hospital survey is to determine if the hospital is in compliance with the CoP set forth at 42 CFR Part 482. Also, where appropriate, the hospital must be in compliance with the PPS exclusionary criteria at 42 CFR Subpart B and the swing-bed requirements at 42 CFR Certification of hospital compliance with the CoP is accomplished through observations, interviews, and document/record reviews. The survey process focuses on a hospital s performance of patient-focused and organizational functions and processes.

10 The hospital survey is the means used to assess compliance with Federal health, safety, and quality standards that will assure that the beneficiary receives safe, quality care and services. Regulatory and Policy Reference The Medicare Conditions of Participation for hospitals are found at 42 CFR Part 482. Survey authority and compliance regulations can be found at 42 CFR Part 488 Subpart A. Should an individual or entity (hospital) refuse to allow immediate access upon reasonable request to either a State Agency or CMS surveyor, the Office of the Inspector General (OIG) may exclude the hospital from participation in all Federal healthcare programs in accordance with 42 CFR The regulatory authority for the photocopying of records and information during the survey is found at 42 CFR (a)(13). The CMS State Operations Manual (SOM) provides CMS policy regarding survey and certification activities. Surveyors assess the hospital s compliance with the CoP for all services, areas and locations in which th