Summary:
Summary Statement of Deficiencies D0000 During a recertification survey on 08/05/24, the laboratory was found OUT OF COMPLIANCE with the following conditions: 493.1290 Condition: Postanalytic Systems D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the January 2024 quality assessment document, review of patient test results, review of the laboratory's quality assessment plan, review of subsequent quality assessment documents, and staff interview, the laboratory's quality assessment