Summary:
Summary Statement of Deficiencies D0000 During an on-site complaint survey completed on October 23, 2025, the laboratory was out of compliance with the following conditions, resulting in immediate jeopardy. 493.1290 Condition: Postanalytic Systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 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 a review of the laboratory's procedures,