Summary:
Summary Statement of Deficiencies 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 review of proficiency testing (PT) records and interview with the testing person (TP), the TP and laboratory director (LD) or designee failed to sign the statement attesting to the routine integration of PT samples into the patient workload using the laboratory's routine methods in two of six chemistry PT events. Findings: 1. Records for two 2020 PT events, three 2021 PT events and one 2022 PT event were reviewed. 2. Records for the 1st and 2nd 2021 chemistry PT events did not include the attestation statements signed by the TP and LD or designee stating that PT samples were integrated into the routine patient workload using routine methods. 3. During the survey on 05/02/2022 at 3:45 pm, the TP confirmed that the 2021 chemistry 1st and 2nd PT event records did not include the signed attestation statements. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to document the investigation into the root cause of and remedial actions taken for unacceptable results for two chemistry analytes in the 2020 3rd PT event. Findings: 1. The laboratory scored a 60% for total cholesterol and a 20% for low-density lipoprotein (LDL) cholesterol in the 2020 chemistry 3rd PT event. 2. Laboratory PT records for the 2020 chemistry 3rd event failed to include the investigation into the root cause of the unacceptable scores and the remedial actions taken for the test system and patient results that were potentially affected to ensure accurate and reliable test results. 3. During the survey on 05/02/2022 at 3:45 pm, the TP confirmed that the 2020 chemistry 3rd PT event records did not include documentation of the investigation and