State Operations Manual

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 Task 2 Task 3 Task 4 Task 5 Task 6

Off-Site Survey Preparation Entrance Activities Information Gathering/ Investigation Preliminary Decision Making and Analysis of Findings Exit Conference 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;

? Complexity of services offered, including outpatient services;

? Type of survey to be conducted;

? Whether the facility has special care units or off-site clinics or locations;

? Whether the facility has a historical pattern of serious deficiencies or complaints; and

? Whether new surveyors are to accompany a team as part of their training.

Qualifications for CAH Surveyors

Minimum qualifications. Surveys must be conducted by individuals who meet minimum qualifications prescribed by CMS. In addition, before any State or Federal surveyor may serve on a CAH survey team (except as a trainee), he/she must have successfully completed the relevant CMS-sponsored basic CAH surveyor training courses and any associated prerequisites. New surveyors may accompany the team as part of their training prior to completing the basic training courses.

Team Coordinator

Surveyors conduct the survey under the leadership of a Team Coordinator. The SA (or the RO for Federal teams) should designate the Team Coordinator. The Team Coordinator is responsible for assuring that all survey preparation and survey activities are completed within the specified timeframes and in a manner consistent with this protocol, SOM, and SA procedures.

Responsibilities of the Team Coordinator include:

? Scheduling the date and time of survey activities;

? Acting as the spokesperson for the team;

? Assigning staff to areas of the CAH or tasks for the survey;

? Facilitating time management;

? Encouraging and facilitating on-going communication among team members;

? Evaluating team progress;

? Coordinating daily team meetings;

? Coordinating any ongoing discussions with CAH leadership (as determined

appropriate by the circumstances and SA/RO policy) and providing on-going feedback, as appropriate, to CAH leadership on the status of the survey;

? Coordinating Task 2 Entrance Conference;

? Facilitating Task 4 Preliminary Decision Making;

? Coordinating Task 5 Exit Conference;

? Ensuring that all survey team activities are conducted in accordance with CMS procedures;

? Ensuring that the team completes all applicable forms prescribed by CMS, including Form CMS-2567.

Task 1 - Off-Site Survey Preparation

General Objective

The objective of this task is to analyze information about the CAH in order to identify areas of potential concern to be investigated during the survey and to determine if those areas, or any special features of the CAH (e.g., provider-based clinics, specialty units, services offered, etc.) require the addition of any specialty surveyors to the team. Information obtained about the CAH will also allow the SA (or the RO for Federal teams) to determine survey team size and composition, and to develop a preliminary survey plan. The type of CAH information needed includes:

? Information from the provider file (to be updated on the survey using the Hospital/CAH Medicare Database Worksheet, Exhibit 286), such as the facility's ownership, the type(s) of services offered, whether the facility is a provider of swing-bed services, any distinct part units, the number, type and location of any off-site locations; and the number and categories of personnel.

? Previous Federal and state survey results for patterns, number, and nature of deficiencies, as well as the number, frequency, and types of complaint investigations and the findings;

? Information from CMS databases available to the SA and CMS. Note the exit date of the most recent survey;

? Waivers and variances, if they exist. Determine if there are any applicable survey directive(s) from the SA or the CMS RO; and

? Any additional information available about the CAH (e.g. the CAH's Web site, any media reports about the CAH, etc.).

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