Summary:
Summary Statement of Deficiencies D0000 . The MMS Lab Services 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 recertification survey performed on April 30, 2025. The following standard-level deficiencies were cited: 493.801 Testing of proficiency testing samples . 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 failed to attest to the integration of proficiency testing samples into the routine patient workload for two of four proficiency testing (PT) events reviewed from 2023 and 2024. 1. The laboratory performed Toxicology testing as confirmed by the laboratory manager during a tour of the laboratory at 10:03 a.m. on 04/30/2025. 2. The laboratory performed PT using the American Proficiency Institute (API) program in 2023 and 2024. 3. Participating testing personnel failed to sign one of two 2023 attestation statements and one of two 2024 attestation statements found in the "API (Proficiency Testing)" folder. See below: 2023 2nd Chemistry Miscellaneous event 2024 1st Chemistry Miscellaneous event 4. During an interview at 11:37 a.m. on 04/30 /2025, the laboratory manager 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 1 --