Rural Health Clinic Surveys– What’s New? Diana Meyer, RN, BSN, CLSSYB Program Manager – Acute Care Facilities DHHS NE – Public Health Licensure Unit diana.meyer@Nebraska.gov Helping People Live better Lives.

LEARNING OBJECTIVES: 1. How often Rural Health Clinics are required to be surveyed. 2. How to prepare for a survey. 3. What are the key changes in the regulations for Rural Health Clinics. 4. Key citations in Rural Health Clinics in Nebraska. Helping People Live better Lives.

HOW OFTEN ARE RURAL HEALTH CLINICS SURVEYED? Recertification Surveys for Medicare/Medicaid –every 4-6 years Complaint Investigations – anytime Immediate Jeopardy – onsite within 2 days High – onsite as soon as possible at the latest within 45 days With the next ‘survey’ 3. Validation Surveys – as assigned by CMS. *NEW* Helping People Live better Lives.

PREPARING FOR A RURAL HEALTH CLINIC SURVEY KNOW the Rural Health Clinic Medicare Conditions for Certification and the Emergency Preparedness Conditions. KNOW the results of the last facility survey. KNOW what to expect when the surveyors show up. Helping People Live better Lives.

KNOW the Medicare Conditions for Certification CMS State Operations Manual – Appendix G https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_g_rhc.pdf OR Federal Register at: www.ecfr.gov Title 42, 491, Subpart A Helping People Live better Lives.

KNOW the EMERGENCY PREPAREDNESS REQUIREMENTS CMS State Operations Manual, Appendix Z §491.12 Conditions for Certification for RHCs AND Conditions for Coverage for FQHCs Helping People Live better Lives.

CONTAINS: Regulatory and Policy References The Survey Protocol Interpretive Guidance Helping People Live better Lives.

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CHANGES with the latest revision of regulations 1-26-2018 In 2004… 8 Medicare Conditions of Coverage….AND 22 pages of information. In 2018, 8 Medicare Conditions for Certification…AND 90 pages of information. Detailed information and clarification. Helping People Live better Lives.

CERTIFICATION PROCEDURES *NEW* J-0001 THROUGH J-003 J-0001. Certification and denial of certification by the Secretary. J-0002. Physicians’ services. 1. By a physician AT the RHC (includes Mobile Units) 2. By a physician of the RHC outside the RHC – MUST have written agreement. J-0003. Visiting Nurse Services provided by the RHC. 1. Criteria services have to meet. 2. Determination of shortage of agencies. Helping People Live better Lives.

COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAWS. J-0010 THROUGH J-0013 J-0011. Being out of compliance with other Federal or State Agency regulations. J-0012. Licensure of the clinic, if required by the State. J-0013. Licensure, certification or registration of personnel. 1. Licenses, credentials current. 2. System in place to check credentials on hire and upon expiration. 3. Staff can only perform activities within their scope of practice. Helping People Live better Lives.

LOCATION OF CLINIC J-0020 through J-0024 J-0021. Location requirements. 1. Criteria for designation as shortage area. 2. Rural area designation criteria. J-0022. Permanent and Mobile Units. 1. A fixed permanent structure. 2. A mobile unit with fixed schedule. 3. Permanent fixed structure with one or more mobile units. J-0023. More than 1 permanent fixed structure has to have it’s own certification as RHC. J-0024. Exceptions to the location requirements. 1. Relocations may not meet the location/shortage requirements. 2. CMS makes that decision AFTER the relocation occurs. Helping People Live better Lives.

PHYSICAL PLANT AND ENVIRONMENT J-0040 through J-0044 J-0041. Construction. J-0042. Maintenance. 1. Preventive maintenance program for all essential mechanical, electrical and patient care equipment. 2. Inspected; used properly; tested; and documented. J-0043. Maintenance. 1. Drugs and biologicals properly stored: a. Manufacturer’s instructions followed. b. Temperature controlled, if applicable. c. Not accessible to unauthorized individuals. d. Locked. Helping People Live better Lives.

PHYSICAL PLANT AND ENVIRONMENT J-0040 through J-0044 Continued…. J-0044. Maintenance. 1. Clean and orderly premises. 2. Required policies and procedures. a. During construction/renovation. b. To prevent the spread of infectious diseases. c. Disposal of waste. d. Employee food storage and eating areas. e. Pest control. Helping People Live better Lives.

ORGANIZATIONAL STRUCTURE J-0060 through J-0062 J-0061. Medical direction by MD/DO 1. Documentation and currently licensed. J-0062. Disclosure of owners and person(s) directing operations of clinic. 1. Organizational chart. 2. Verify information on CMS-29 and other written records. Helping People Live better Lives.

STAFFING AND STAFF RESPONSIBILITIES J-0080 through J-0102 J-0081. Staffing – Physician requirements and qualifications. J-0082. Staffing – APRN and PA requirements and qualifications. J-0083. Staffing – Midwife, social worker or psychologists, not required. J-0084. Ancillary personnel must be supervised by the professional staff. 1. RNs, LPNs, Lab techs, MAs. Helping People Live better Lives.

STAFFING AND STAFF RESPONSIBILITIES J-0080 through J-0102 Continued… J-0085. Sufficient staff all times the clinic is open. J-0086. APRN or PA must provide services at least 50% of time clinic is open. J-0100. Physician responsibilities: 1. Medical direction and medical supervision for healthcare staff. 2. Provides care and writes medical orders for patients at the RHC. J-0101. Physician, APRN and PA periodically review patient records. J-0102. APRN or PA responsibilities. Helping People Live better Lives.

PROVISION OF SERVICES J-0120 through J-0140 J-0121. Services offered are in accordance with federal, state and local laws. J-0122. Basic service requirements: 1. ‘Primarily engaged’ in providing outpatient/ambulatory health care services 2. Direct services – diagnostic, therapeutic services usually supplied in MD office. J-0123. Physician, APRN and PA participate in development, review or written policies/services: 1. Professional group – one member is NOT a member of the clinic staff. 2. Policies reviewed annually and documented. Helping People Live better Lives.

J-0120 through J-0140 Continued… PROVISION OF SERVICES J-0120 through J-0140 Continued… J-0124. Policies include: 1. Description of services provided by the clinic directly and by contract. 2. Guidelines for medical management of health problems, those requiring medical consult and/or requiring referral. J-0125. Rules for storage, handling and administration of drugs and biologicals. 1. Compliance with USP and other accepted professional principles. 2. Environmental conditions. 3. Security. 4. Record keeping, receipt and disposition of all scheduled drugs. 5. Compounding and use of Compounded Sterile Preparations (CSPs). 6. Expiration and Beyond Use Dates (BUDs) 7. Medication administration practices – scope of practice. Helping People Live better Lives.

J-0120 through J-0140 Continued… PROVISION OF SERVICES J-0120 through J-0140 Continued… J-0135. Laboratory Requirements. Six required tests. J-0136. Medical emergency procedures for common life threatening injuries and illnesses. 1. Policies 2. Emergency medications and supply of drugs and biologicals J-0140. Services provided through agreements or arrangements. 1. Required agreements with: a. Hospital or CAH b. Physician c. Diagnostic testing facility d. CLIA lab 2. Documentation of agreements/arrangements. Helping People Live better Lives.

PATIENT HEALTH RECORDS J-0150 through J-0154 J-0151. Policies and procedures regarding Medical Records. 1. Designated member of professional staff responsible for: a. Maintaining records b. Ensuring records are complete, accurate, accessible and organized. J-0152. Records include: 1. Identification and social data. 2. Consent forms. 3. Medical history. 4. Assessment and summary. 5. Examinations, lab, diagnostic, and consult reports. 6. Orders, treatments, medications, and other information. 7. Signatures – dated, timed and signed. Helping People Live better Lives.

PATIENT HEALTH RECORDS J-0150 through J-0154 Continued… J-0153. Confidentiality maintained, records safeguarded. 1. Written policies: a. Who may use the records – authorized individuals b. Backup for EHR systems c. Deleting records d. Consent from patient or legal representative J-0154. Retention of records. 1. Retained for minimum of 6 years within the RHC. 2. Prompt retrieval. Helping People Live better Lives.

PROGRAM EVALUATION J-0160 through J-0162 J-0161. Documentation of annual evaluation of RHCs total program. 1. Who conducts review – qualifications a. Review of number of patients served and volume of services b. Active and closed clinical records (5% or 50 records, whichever is less) c. Health care policies, do practitioners adhere to the policies. d. Were services provided appropriate e. Documented in a summary report, including findings and recommendations. J-0162. Evaluation findings and corrective action. 1. Documentation that clinic leadership reviewed the evaluation findings. 2. Documentation of any corrective action 3. Documentation of the rationale for not taking recommended corrective action. Helping People Live better Lives.

DEFICIENCIES CITED IN RURAL HEALTH CLINICS IN NEBRASKA IN PAST 5 YEARS 2013 2014 2015 2016 2017 J-0023 Maintenance * J-0023 Maintenance * J-0022 Maintenance * J-0062 Direct Services – Emergency * J-0070 Records Systems * J-0072 Protection of Record Information * J-0005 Licensing and Registration of Personnel * J-0069 * J-0080 Purpose of Evaluation * J-0086 Evaluation Findings and Action Taken * J-0083 Purpose of Evaluation * Helping People Live better Lives.

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WHO DO I CONTACT WITH QUESTIONS? The Surveyors. The Acute Care Team. luana.collins@nebraska.gov suzette.moeller@nebraska.gov 402-471-3484 The Program Manager. diana.meyer@nebraska.gov 402-223-6019 Helping People Live better Lives.