State Operations Manual 
             Appendix W - Survey Protocol, Regulations and 
           Interpretive Guidelines for Critical Access Hospitals 
                  (CAHs) and Swing-Beds in CAHs 
                                
                          (Rev. 200, 02-21-20) 
                                
         Transmittals for Appendix W 
          
        INDEX 
          
                           Survey Protocol 
        Introduction 
        Regulatory and Policy Reference 
        Tasks in the Survey Protocol 
        Survey Team 
        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 
                                
                  Regulations and Interpretive Guidelines for CAHs 
          
        §485.601  Basis and Scope 
        §485.603  Rural Health Network 
        §485.604  Personnel Qualifications 
        §485.606  Designation and Certification of CAHs 
        §485.608  Condition of Participation: Compliance With Federal, State, and Local Laws and 
           Regulations 
        §485.610 Condition of Participation: Status and Location 
        §485.612 Condition of Participation: Compliance With CAH Requirements at the Time of 
           Application 
        §485.616 Condition of Participation: Agreements 
        §485.618 Condition of Participation: Emergency Services 
        §485.620 Condition of Participation: Number of Beds and Length of Stay 
        §485.623 Condition of Participation: Physical Plant and Environment 
        §485.625 Condition of Participation: Emergency Preparedness 
      §485.627 Condition of Participation: Organizational Structure 
      §485.631 Condition of Participation: Staffing and Staff Responsibilities 
      §485.635 Condition of Participation: Provision of Services 
      §485.638 Condition of Participation: Clinical Records 
      §485.639 Condition of Participation: Surgical Services 
      §485.640 Condition of Participation: Infection Prevention and Antibiotic Stewardship   
         Program 
      §485.641 Condition of Participation: Quality Assessment and Performance Improvement 
      Programs 
      §485.642 Condition of Participation: Discharge Planning 
      §485.643 Condition of Participation: Organ, Tissue, and Eye Procurement 
      §485.645 Special Requirements for CAH Providers of Long-Term Care Services (“Swing-
         Beds”) 
      §485.647 Condition of Participation: Psychiatric and Rehabilitation Distinct Part Units 
      Emergency Medical Treatment and Labor Act (EMTALA) - C-Tags - §489.24(l), §489.20(m), 
      §489.20(q), §489.20(r), §489.24(j), §489.24, §489.24(a), §489.24(c), §489.24(d), §489.24(e), 
      §489.24(f) 
       
                                                           Survey Protocol 
                      
                     Introduction 
                      
                     Critical Access Hospitals (CAHs) are required to be in compliance with the Federal 
                     requirements set forth in the Medicare Conditions of Participation (CoP) in order to 
                     participate in Medicare and be eligible to receive Medicare/Medicaid payment.  The goal 
                     of a CAH survey is to determine if the CAH is in compliance with the CoP set forth at 42 
                     CFR Part 485 Subpart F. 
                      
                     Certification of CAH compliance with the CoP is accomplished through observations, 
                     interviews, and document/record reviews.  The survey process focuses on a CAH’s 
                     performance of organizational and patient-focused functions and processes as well as the 
                     safety of the environment of care within the CAH.  The CAH 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 within an environment that is safe. 
                      
                     Regulatory and Policy Reference 
                      
                         •   The Medicare Conditions of Participation for CAHs are found at 42 CFR Part 485 
                             Subpart F. 
                        
                         •   Survey authority and compliance regulations can be found at 42 CFR Part 488 
                             Subpart A. 
                        
                         •   If an individual or entity (CAH) refuses to allow immediate access to either a 
                             State Survey Agency (SA) or CMS surveyor, the Office of Inspector General 
                             (OIG) may terminate the CAH from participation in the Medicare/Medicaid 
                             programs in accordance with 42 CFR 1001.1301.  
                              
                         •   If a CAH fails to grant immediate access upon a reasonable request to an SA or 
                             other CMS-authorized entity for the purpose of determining, in accordance with 
                             42 CFR 488.3, whether the CAH meets the applicable CoP, CMS may terminate 
                             the CAH Medicare provider agreement in accordance with 42 CFR 489.53(a)(18). 
                        
                         •   If a CAH refuses to permit copying of any records or other information by, or on 
                             behalf of , CMS, as necessary to determine or verify compliance with 
                             participation requirements, CMS may terminate the CAH’s Medicare provider 
                             agreement in accordance with 42 CFR 489.53(a)(13). 
                               
                         •   The CMS State Operations Manual (SOM) provides CMS policy regarding survey 
                             and certification activities. 
                      
                     Surveyors assess CAH compliance with the CoPs for all services, areas and locations in 
                     which the provider receives reimbursement for patient care services billed under its CMS 
                     Certification Number (CCN), as well as certain entities that provide services to the CAH 
                     on a contractual basis.  These areas include all inpatient and outpatient services and 
                   practice locations, buildings and facilities (including, but not limited to, generators, 
                   electrical rooms, food services, HVAC, supply areas, sterilization areas, etc.). 
                    
                   Although the survey generally occurs during daytime working hours (Monday through 
                   Friday), surveyors may conduct the survey at other times.  These survey hours may 
                   include weekends and times outside of daytime (Monday through Friday) working hours.  
                   When the survey begins at times outside of normal work times, the survey team modifies 
                   the survey, if needed, in recognition of patients’ activities and the staff available. 
                    
                   All CAH surveys are unannounced.  Do not provide CAHs with advance notice of the 
                   survey. The SAs, Accreditation Organizations (AOs), and CMS may not make any 
                   communications or requests to a CAH that would amount to advance notice of a survey 
                   (with the exception of providing resurvey timeframes as stated in the SOM). 
                    
                   Tasks in the Survey Protocol 
                    
                   Listed below, and discussed in this document, are the tasks that comprise the survey 
                   protocol for CAH surveys. 
                    
                    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 
                    
                   Survey Modules for Specialized CAH services 
                    
                   The modules for CAH distinct part psychiatric units and rehabilitation units and CAH 
                   swing beds are attached to this document.  The survey team is expected to use all the 
                   modules that apply to the CAH being surveyed.  For example if the CAH has swing beds, 
                   a distinct part rehabilitation unit, and a distinct part psychiatric unit, the team will use all 
                   three modules to conduct the survey of those activities. 
                    
                   Survey Team 
                    
                   Size and Composition 
                    
                   The SA (or the CMS Regional Office (RO) for Federal teams) decides the composition 
                   and size of the team.  In general, a suggested survey team for a full survey of a CAH 
                   would include 1-4 surveyors who will be at the facility for one or more days. Each survey 
                   team should include at least one RN with hospital/CAH survey experience, as well as 
                   other surveyors who have the expertise needed to determine whether the CAH is in 
                   compliance.  Survey team size and composition are normally based on the following 
                   factors: 
                    
                       •   Size of the facility to be surveyed, based on average daily census;