Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Sabine Rural Health Center - CLIA # 19D0465052 on March 12, 2018. Sabine Rural Health Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1230 CONDITION: General Laboratory System 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure that proficiency testing was performed by personnel who routinely perform laboratory testing. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2017 and 2018 revealed the following proficiency testing was performed by testing Personnel 3, qualified for waived testing only: 2017 Urine Drug Screen Event 1, sample UDS 03 2017 Hematology Event 2, Complete Blood Count samples 06 and 10 2. In interview on March 12, 2018, Personnel 2 confirmed that Personnel 3 was a testing personnel for waived testing only as should not have performed proficiency testing for moderate complexity testing. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview with laboratory personnel, the laboratory failed to monitor and evaluate the overall quality of the General Laboratory System. Findings: 1. The laboratory failed to successfully verify the accuracy of the performance of urine drug screening at least twice annually. Refer to D5217. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Technical Consultant were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 1 serves as the Technical Consultant. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Technical Consultant. 3. Review of personnel records revealed competency assessments for the duties of Technical Consultant were not documented. 4. In interview on March 12, 2018, Personnel 1 stated the laboratory director had a written delegation of duties to the Technical Consultant. Personnel 1 confirmed this document did not address competency assessment of the Technical Consultant. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to successfully verify the accuracy of the performance of urine drug screening at least twice annually. Findings: 1. Review of American Proficiency Instititute (API) proficiency testing records revealed the following scores for Pehncyclidine (PCP): a. 2017 Event 1: 67% b. 2017 Event 2: 67% 2. In interview on March 12, 2018 Personnel 1 & 2 confirmed the laboratory did not successfully participate in Proficieny Testing for PCP. Personnel 3 confirmed the laboratory ceased patient testing while further investigation was to be completed. D5781