Summary:
Summary Statement of Deficiencies 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 review of laboratory policy, review of 2024 personnel competency records, and review of 2024 patient testing logs 12/03/24, the laboratory failed to follow policy for competency assessment of testing personnel (TP) whom perform Potassium Hydroxide (KOH) testing, 7 patients were tested from 03/25/24 until date of survey 12 /03/24. Findings: Review of laboratory policy "Proficiency Testing Competency and CLIA competency assessment" revealed "CLIA guidelines require assessment of personnel competency during the first year of test performance for Moderate or High Complexity testing. Thereafter, evaluation will be performed at new start up, additionally after first 3 months, 6 months then annually....Personnel competency must be assessed by the Laboratory Director or Technical Consultant and will be an on-going process at this facility bi-annually.". Review of 2024 TP competency records for TP #2 revealed no documentation of an assessment of competency for the KOH testing performed. Review of 2024 patient testing logs for the KOH testing revealed 7 patients were tested from 03/25/24 until date of survey 12/03/24. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, absence of verification of accuracy records for the KOH testing performed and interview with HT 12/03/24, the laboratory failed to enroll in proficiency testing (PT) or perform a verification of accuracy for KOH since testing began 03/25/24, a period of approximately 9 months. Findings: Review of laboratory policies "Mycology" revealed "This lab has joined a proficiency testing program with The American Proficiency Testing Institute. Membership receipt attached. This lab will have reviews done at least bi-annually. Results will be documented in manuals....Diagnosis for fungus or dermatophytosis can be made with several different laboratory tests. 1. KOH prepared slide....". Review of laboratory records revealed no documentation the laboratory had either enrolled in a PT program or performed an alternative verification of accuracy for KOH since testing began 03/25 /24. Interview with HT at approximately 11:45 a.m. confirmed there was no documentation of enroll in a PT program or the performance of a verification of accuracy for KOH. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)