Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of 2023 and 2024 API (American Proficiency Institute) proficiency testing records and interview with the Clinical Compliance Coordinator 7/16/24, the laboratory failed to retain all proficiency testing records for 2 of 2 test events for at least two years from the date of the event. Findings: Review of 2023 and 2024 API proficiency testing records revealed the laboratory was enrolled for the 2023 Microbiology 3rd event and for 3 Microbiology events in 2024. The only records available were the graded results from the 2024 Microbiology 1st event. Graded results from the 2023 Microbiology 3rd event were printed by the Clinical Compliance Coordinator during the survey. The laboratory did not have report forms, submitted results confirmations, and signed attestation statements available for either event. During interview at approximately 11:30 a.m., the Clinical Compliance Coordinator stated that the laboratory's results are entered online. She stated they did not realize they needed to maintain copies of signed attestation statements and graded results. 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 -- 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 the laboratory's policies and procedures, review of personnel records, and interview with the Operations Officer 7/16/24, the laboratory failed to follow their established policy for semiannual and annual competency evaluations for 5 of 5 providers who perform patient KOH (potassium hydroxide) preps. Findings: Review of the laboratory's "PROFICIENCY TESTING Competency and CLIA competency assessment" policy revealed "... Evaluation and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual sees patient specimens. After the first year, competency assessment must be performed at least annually. ... The following procedures are requirements for assessment of competency for all personnel performing laboratory testing. 1. Direct observations of routine patient test performance... 2. Monitoring the recording and reporting test results 3. Review of intermediate test results, and preventive maintenance records 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of test performance through testing previously testing samples 6. Assessment of problem solving skills. ... Results of each Competency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent records. ..." Review of personnel records revealed no documentation of semiannual or annual competency evaluations for the five providers who perform KOH preps on patients. During interview at approximately 11:05 a.m., the Operations Officer confirmed the laboratory director had not performed and documented competency evaluations for the providers who perform KOH testing. 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)