Summary:
Summary Statement of Deficiencies D0000 A validation survey was completed on July 7, 2024. The Fredonia Regional Hospital laboratory was found not in compliance with the following CONDITIONAL LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the failure to have written procedures, availability of procedures with required information, testing performed prior to approved procedures, failure to include