If the hospital is a psychiatric hospital and if the survey team will be to maintain, as described above, is not consistent with the Medicare CoPs. For.
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State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals Table of Contents (Rev. 200, 02-21-20) Transmittals for Appendix A Survey Protocol Introduction Task 1 – Off -Site Survey Preparation Task 2 – Entrance Activities Task 3 – Information Gathering/In vestigation Task 4 – Preliminary Decision Making and Analysis of Findings Task 5 – Exit Conference Task 6 Œ 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 §482.1 Basis and Scope §482.2 Provision of Emergency Services by Nonparticipating Hospitals §482.11 Condition of Participation: Compliance with Federal, State and Local Laws §482.12 Condition of Participation: Governing Body §482.13 Cond ition of Participation: Patient’s Rights §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program §482.22 Condition of Participation: Medical staff §482.23 Condition of Participation: Nursing Services §482.24 Condition of Participation: Medical Record Services §482.25 Condition of Participation: Pharmaceut ical Services

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§482.26 Condition of Participation: Radiologic Services §482.27 Condition of Participation: Laboratory Services §482.28 Condition of Participation: Food and Dietetic Services §482.30 Condition of Participation: Utilization Review §482.41 Condition of Participation: Physical Environment §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs §482.43 Condition of Participation: Discharge Planning §482.45 Condition of Participation: Organ, Tissue and Eye Procurement §482.51 Condition of Participation: Surgical Services §482.52 Condition of Participation: Anesthesia Services §482.53 Condition of Participation: Nuclear Medicine Services §482.54 Condition of Participation: Outpatient Services §482.55 Condition of Participation: Emergency Services §482.56 Condition of Participation: Rehabilitation Services §482.57 Condition of Participation: Respiratory Services §482.60 Condition of Participation: Special provisions applying to psychiatric hospitals §482.61 Condition of Participation: Special medical record requirements for psychiatric hospitals §482.62 Condition of Participation: Special staff requirements for psychiatric hospitals

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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 412.20 Subpart B and the swing -bed requirements at 42 CFR 482.66 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. The hospital survey is the means used to ass ess 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 42CFR 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 al l Federal healthcare programs in accordance with 42 CFR 1001.1301 . The regulatory authority for the photocopying of records and information during the survey is found at 42 CFR 489.53(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 the provider receives reimbursement for patient care services billed under its provider number. Although the survey generally occurs during daytime working hours (Monday through Friday), surveyor s may conduct the survey at other times. This may include weekends and times outside of normal 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.

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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 Hospital Services The modules for PPS -exempt units (psychiatric and rehabilitation), psychiatric hospitals, rehabilitation hospitals and swing -bed hospitals are attached to this document. The surve y team is expected to use all the modules that apply to the hospital being surveyed. For example, if the hospital has swing -beds, a PPS excluded rehabilitation unit, and a PPS excluded psychiatric unit, the team will use those three modules in addition to this protocol to conduct the survey. If the hospital is a rehabilitation hospital, the team will use the rehabilitation hospital module in addition to this protocol to conduct the survey. If the hospital is a psychiatric hospital and if the survey team will be assessing the hospital™s compliance with both the hospital CoPs and psychiatric hospital special conditions, the team will use the psychiatric hospital module in addition to this protocol to conduct the survey. Survey Team Size and Composition The SA (or the RO for Federal teams) decides the composition and size of the team. In general, a suggested survey team for a full survey of a mid -size hospital would include two -four surveyors who will be at the facility for 3 or more days. Each hospital su rvey team should include at least one RN with hospital survey experience, as well as other surveyors who have the expertise needed to determine whether the facility is in compliance. Survey team size and composition are normally based on the following fac tors: 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.

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Training for Hospital Surveyors Hospital surveyors should have the necessary training and e xperience to conduct a hospital survey. Attendance at a Basic Hospital Surveyor Training Course is suggested. New surveyors may accompany the team as part of their training prior to completing the Basic Hospital Surveyor Training Course. Team Coordinato r The survey is conducted 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 comp leted within the specified time frames 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 hospital or tasks for the survey; Facilitating time management; Encouraging on -going communication among team members; Evaluating team progress and coordinating daily team meetings; Coordinating any ongoing conferences with hospital leadership (as determined appropriate by the circumstances and SA/RO policy) and providing on -going feedback, as appropriate, to hospital leadership on the status of the survey; Coordinating Task 2, Entrance Conference; Facilitating Task 4, Preliminary Decision Making; Coordinating Task 5, Exit Conference; and Coordinating the preparation of the Form CMS -2567. Task 1 – Off-Site Survey Preparation General Objective The objective of this task is to analyze information about the provider in order to identify areas of potential concern to be investigated during the survey and to determine if those

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Date, location and time team members will meet to enter the facility; The time for the daily team meetings; and Potential date and time of the exit conference. Gather copies of resources that may b e needed. These may include: Medicare Hospital CoP and Interpretive Guidelines ( Appendix A ); Survey protocol and modules; Immediate Jeopardy ( Appendix Q ); Responsibilities of Medicare Participating Hospitals in Emergency Cases (Appendix V); Hospital Swing -Bed Regulations and Interpretive Guidelines ( Appendix T ); Hospital/CAH Medicare Database Worksheet, Exhibit 286 ; Exhibit 287 , Authorization by Deemed Provider/Supplier Selected for Accreditation O rganization Validation Survey; and Worksheets for swing -bed, PPS exclusions, and restraint/seclusion death reporting. Task 2 – Entrance Activities General Objectives The objectives of this task are to explain the survey process to the hospital and obta in the information needed to conduct the survey. General Procedures Arrival The entire survey team should enter the hospital together. Upon arrival, surveyors should present their identification. The team coordinator should announce to the Administra tor, or whoever is in charge, that a survey is being conducted. If the Administrator (or person in charge) is not onsite or available (e.g., if the survey begins outside normal daytime Monday -Friday working hours), ask that they be notified that a survey is being conducted. Do not delay the survey because the Administrator or other hospital staff is/are not on site or available.

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Entrance Conference The entrance conference sets the tone for the entire survey. Be prepared and courteous, and make requests, not demands. The entrance conference should be informative, concise, and brief; it should not utilize a significant amount of time. Conduct the entrance conference with hospital administrative staff that is available at the time of entrance. Dur ing the entrance conference, the Team Coordinator should address the following: Explain the purpose and scope of the survey; Briefly explain the survey process; Introduce survey team members, including any additional surveyors who may join the team at a later time, the general area that each will be responsible for, and the various documents that they may request; Clarify that all hospital areas and locations, departments, and patient care settings under the hospital provider number may be surveyed, in cluding any contracted patient care activities or patient services located on hospital campuses or hospital provider based locations; Explain that all interviews will be conducted privately with patients, staff, and visitors, unless requested otherwise by the interviewee; Discuss and determine how the facility will ensure that surveyors are able to obtain the photocopies of material, records, and other information as they are needed; Obtain the names, locations, and telephone numbers of key staff to who m questions should be addressed; Discuss the approximate time, location, and possible attendees of any meetings to be held during the survey. The team coordinator should coordinate any meetings with facility leadership; and Propose a preliminary date a nd time for the exit conference. During the entrance conference, the Team Coordinator will arrange with the hospital administrator, or available hospital administrative supervisory staff if he/she is unavailable to obtain the following: A location (e.g., conference room) where the team may meet privately during the survey; A telephone for team communications, preferably in the team meeting location;

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A list of current inpatients , providing each patient™s name, room number, diagnosis(es), admission date, age, attending physician, and other significant information as it applies to that patient. The team coordinator will explain to the hospital that in order to complete the survey within the allotted time it is important the survey team is given this informa tion as soon as possible, and request that it be no later than 3 hours after the request is made. SAs may develop a worksheet to give to the facility for obtaining this information; A list of department heads with their locations and telephone numbers; A copy of the facility™s organizational chart; The names and addresses of all off -site locations operating under the same provider number; The hospital™s infection control plan; A list of employees; The medical staff bylaws and rules and regulations; A list of contracted services; and A copy of the facility™s floor plan, indicating the location of patient care and treatment areas; Arrange an interview with a member of the administrative staff to complete the Hospital/CAH Medicare Database Worksheet t hat will be used to update the provider™s file in the Medicare database. The worksheet may not be given to hospital personnel for completion. Hospital Tours Guided tours of the hospital are not encouraged and should be avoided. While a tour of a small facility may take place in less than one -man hour, a tour of a large facility could consume several man hours of allocated survey time and resources that are needed to conduct the survey. Initial On -Site Team Meeting After the conclusion of the En trance Conference, the team will meet in order to evaluate information gathered, and modify surveyor assignments, as necessary. Do not delay the continuation of the survey process waiting for information from the provider, but adjust survey activities as necessary. During the on -site team meeting, team members should:

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Review the scope of hospital services; Identify hospital locations to be surveyed, including any off -site locations; Add survey protocol modules and adjust surveyor assignments, as necess ary, based on new information; Discuss issues such as change of ownership, sentinel events, construction activities, and disasters, if they have been reported; Make an initial patient sample selection (The patient list may not be available immediately af ter the entrance conference, therefore the team may delay completing the initial patient sample selection a few hours as meets the needs of the survey team); and Set the next meeting time and date. Sample Size and Selection To select the patient sample, review the patient list provided by the hospital and select patients who represent a cross -section of the patient population and the services provided. Patient logs (ER, OB, OR, restraint, etc) may be used in conjunction with the patient list to assure t he sample is reflective of the scope of services provided by the hospital. Whenever possible and appropriate, select patients who are in the facility during the time of survey (i.e., open records). Open records allow surveyors to conduct a patient -focuse d survey and enable surveyors to validate the information obtained through record reviews with observations and patient and staff interviews. There may be situations where closed records are needed to supplement the open records reviewed (e.g., too few op en records, complaint investigation, etc), surveyors should use their professional judgment in these situations and select sample that will enable them to make compliance determinations. If it is necessary to remove a patient from the sample during the su rvey, (e.g., the patient refuses to participate in an interview), replace the patient with another who fits a similar profile. This should be done as soon as possible in the survey. Select the number of patient records for review based on the facility™s average daily census. The sample should be at least 10 percent of the average daily census, but not fewer than 30 inpatient records. For small general hospitals (this reduction does not apply to surgical or other specialty hospitals) with an average dail y census of 20 patients or less, the sample should not be fewer than 20 inpatient records, provided that number of records is adequate to determine compliance. Within the sample, select at least one patient from each nursing unit (e.g., med/surg, ICU, OB, pediatrics, specialty units, etc). In addition to the inpatient sample, select a sample of outpatients in order to determine compliance in outpatient departments, services, and locations. The sample size may be expanded as needed to assess the hospital™ s compliance with the CoP.

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