Summary:
Summary Statement of Deficiencies D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: A. Based on lack of documentation, review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interview with the Director of Clinical Services (DCS), the laboratory failed to provide 3 of 3 AAB-MLE attestation statements for Provider Performed Microscopy (PPM) PT testing events performed in 2023. Findings include: 1. On the day of survey, 01/21/2025, the laboratory failed to provide attestation statements for the following 3 of 3 AAB-MLE Chemistry PT events for PPM examinations (vaginal wet mount/potassium hydroxide prep) performed in 2023: - Chemistry M1 2023 - Chemistry M2 2023 - Chemistry M3 2023 2. The DCS confirmed the findings above on 01/21/2025 at 12:10 pm. B. Based on review of the laboratory's proficiency testing (PT) policy, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT records and interview with the Director of Clinical Services (DCS), the laboratory director (LD)/designee and testing personnel (TP) failed to attest to the routine integration of samples into the patient workload for 3 of 3 AAB-MLE Chemistry: Provider Performed Microscopy (PPM) PT events performed in 2024. Findings include: 1. The laboratory's proficiency testing policy states, "Assigned staff test samples, record results on the testing sheet and signs attestation. Completed form is given, faxed or scanned and emailed to the laboratory director for signature." 2. On 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 -- the day of survey, 01/21/2025 at 9:42 am., review of the laboratory's AAB-MLE PT records revealed the LD/designee and TP failed to sign attestation statement forms for 3 of 3 AAB-MLE Chemistry PT events for PPM examinations (vaginal wet mount /potassium hydroxide prep) performed in 2024: - Chemistry M1 2024 - Chemistry M2 2024 - Chemistry M3 2024 3. The DCS confirmed the findings above on 01/21/2025 at 12:10 pm. 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 lack of documentation, review of the laboratory's personnel policy, and interview with the Director of Clinical Services (DCS), the laboratory failed to follow established policies to assess the competency of 1 of 2 Technical Consultants (TC) for their supervisory responsibilities performed in 2023 and 2024. Findings include: 1. The laboratory's personnel policy states, "Technical Consultants must be privileged by the Lab Director and are assessed for competency at the completion of training, at 6 months, and annually." 2. On the day of the survey, 01/21/2025, the laboratory failed to provide competency records for 1 of 2 TC (CMS 209 personnel #3) for their supervisory responsibilities performed in 2023 and 2024. 3. The DCS confirmed the findings above on 01/21/2025 at 12:10 pm. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)