Summary:
Summary Statement of Deficiencies D0000 The Metropartners Obstetrics & Gynecology, PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the validation survey performed on February 12, 2025. The following standard-level deficiencies were cited: 493.801 Testing of proficiency testing samples 493.1105 Retention requirements 493.1251 Procedure manual 493.1413 Technical consultant responsibilities . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the testing personnel (TP) failed to attest to the integration of proficiency testing samples into the routine patient workload for one of three proficiency testing (PT) events reviewed from 2023. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10: 07 AM on 2/12/2025. 2. The laboratory performed PT using the American Association of Bioanalysts program in 2023. 3. All participating laboratory testing personnel (TP) were required to sign the attestation statements as established in the Proficiency Testing Guidelines policy found in the Procedure and Policy Manual. 4. Participating laboratory TP failed to sign one of three 2023 attestation statements found in the PT manual. See below. 2023 M2 Event - Chemistry 5. During an interview at 12:55 PM on 2/12/25, the Technical Consultant confirmed the above finding. . 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 -- D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing (PT) records for at least two years in 2023. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:07 AM on 2/12/2025. 2. The laboratory performed Microbiology PT using the American Association of Bioanalysts program in 2023. 3. The laboratory was required to retain all PT records as established in the Proficiency Testing procedure found in the Procedure and Policy Manual. 4. The following AAB PT documentation was not present in laboratory records on the date of survey. The laboratory was unable to provide these documents upon request. 2023 M3 Event results 2023 M3 Event attestation statement 5. In an interview at 12:55 PM on 2/12/2025, the TC confirmed the above finding. . 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)