Summary:
Summary Statement of Deficiencies D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of 2025 monthly quality assessment (QA) records, review of technical consultant (TC) on-site "List of Issues" report and interview with TC, 01/07/26, the laboratory director failed to ensure the established monthly QA records were performed by testing personnel (TP #2) as required per QA policy. Findings: Review of laboratory policy "Annual Quality Assessment Requirements" revealed "AHMG Moderate and High complex laboratories are expected to perform QA monthly. The labs will be assigned QA Monitors by the Laboratory Director/Technical Consultant...The AHMG Laboratory Accreditation Coordinators will visit Moderately complex labs on at least a semi-annual basis to review all laboratory data. Reports will consist of a List of Issues report, if applicable, returned to the laboratory(s).". Review of 2025 monthly QA monitors revealed the following 14 of 22 QA monitors assigned to TP #2 were not performed as required by the laboratory QA policy; January 2-1, February 2-2, April 5-8, May 6-1 and 6-2, July 7-1 and 8-1, August 8-2 and 9-1, September 10-1, October 10-2 and 11-1, November 11-3 and 12-1. Review of 2025 monthly QA monitors revealed the following 4 of 22 QA monitors assigned to TP #2 were not completed until December of 2025: March - EMR Chart Review, April 5-1, June - EMR Chart Review, and September - EMR Chart Review. Review of September 2025 TC quarterly on-site "List of Issues" report revealed TP #2 was cited for failure to perform the monthly QA monitors. The report was signed by TP #2 in acknowledgement of the issue. During interview with TC at approximately 10:00 a.m. the TC stated TP # 2 was trained in March in regards to the QA monitors by completing QA Monitors; January 1-1, February 4-1 and March 4-2. 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 -- TC stated TP #2 was asked to complete QA Monitors January 2-1 and February 2-2 but during the May TC on-site visit the monitors were not completed. They also stated no additional monitors were completed by the September TC on-site visit and at that time TP #2 was cited for not completing the QA monitors as required. The TC also confirmed 14 of the 22 monthly QA monitors were not completed at the time of the December TC on-site visit. -- 2 of 2 --