Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on November 07, 2019. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 Proficiency Test (PT) document review and staff interview, the laboratory director failed to attest that (PT) samples were tested in the same manner as patient samples by not signing (PT) attestation statements. Findings include: 1.) College of American Pathology (CAP) PT document review revealed the laboratory director failed to sign (PT) attestation statements for the following events: (1st, 2nd, 3rd events of 2018) and ( 2nd event of 2019) for the specialty of Toxicology. 2.) An interview with the Technical Supervisor (TS) staff #5 (CMS 209) on 11/7/2019 at approximately 12:30 pm confirmed the above attestations were not signed by the laboratory director in 2018 and 2nd event of 2019. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H 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 2 -- This STANDARD is not met as evidenced by: Based on Proficiency Test (PT) documents review and staff interview, the laboratory director failed to review and evaluate the results of the College of American Pathology (CAP) proficiency tests for 2018 and 2019 (2nd event). Findings include: 1.) College of American Pathology (CAP) PT document review revealed the laboratory director failed to sign (PT) results statements for the following events: (1st, 2nd, 3rd events of 2018) and ( 2nd event of 2019) for the specialty of Toxicology. 2.) An interview with the Technical Supervisor (TS) staff #5 (CMS 209) on 11/7/2019 at approximately 12:40 pm confirmed the above (PT) results evaluation forms were not signed by the laboratory director in 2018 and 2nd event of 2019. -- 2 of 2 --