Summary:
Summary Statement of Deficiencies D0000 An announced onsite initial survey was performed on October 18, 2023, and the laboratory was found to NOT be in compliance with the following CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1250 Analytic Systems 493.1403 Laboratory Director, (moderate complexity). 493.1441 Laboratory Director, (high complexity) 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 surveyor observation, review of laboratory documentation and confirmed in interview, the laboratory failed to meet the requirements of the analytic systems for 7 of 7 months in 2023 (March-September) as evidenced by: I. The laboratory failed to have policies in place that included all required components of laboratory testing for 7 of 7 months in 2023 (March-September). (Refer to D5403) II. The laboratory failed to document Toluidine Blue 1% control slides for intended reactivity each day of patient testing for 20 of 20 histopathology patients tested in September 2023. (Refer to D5473) III. The laboratory failed to have a