Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on March 21, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) evaluation documents, and confirmed by staff interview, the Laboratory failed to receive successful scores for Provider Performed Microscopy (PPM), Urine Sediment for the 1st, 2nd, and 3rd events for 2021, and 1st and 2nd events for 2022. Findings: 1. Review of the AAB PT documents for PPM Urine Sediment in 2021, and 2022, the Laboratory received the following scores for 2021, and 2022: PPM urine sediment, 2021, event 1 a score of 50% was received. event 2 a score of 50% was received event 3 a score of 50% was received PPM urine sediment 2022, event 1 a score of 50% was received event 2 a score of 50% was received event 3 a score of 100% was received PPM urine sediment 2023, event 1 a score of 100% was received. 2. Interview with Testing Personnel (TP) 2 on the Centers for Medicare/Medicaid Services,(CMS) Testing Personnel List(form 209) and the Laboratory Director on March 21, 2023 at approximately 12 pm, in the nursing station, confirmed the aforementioned statements. D5983 PPM LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1359 The laboratory director is responsible for the overall operation and administration of 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 -- the laboratory, including the prompt, accurate, and proficient reporting of test results. This STANDARD is not met as evidenced by: Based on review of the American Associates of Bioanalysis, (AAB) Proficiency Testing (PT), and staff interview, the Laboratory Director(LD) failed to achieve successful scores in Provider Performed Microscopy (PPM) PT scores for 2021, events 1, 2 and 3, and for 2022, events 1 and 2. Findings: 1. Review of the AAB PT documents for PPM Urine Sediment in 2021, and 2022, the Laboratory received the following scores for 2021, and 2022, 2023. PPM urine sediment, 2021, event 1 a score of 50% was received. event 2 a score of 50% was received event 3 a score of 50% was received PPM urine sediment 2022, event 1 a score of 50% was received event 2 a score of 50% was received event 3 a score of 100% was received PPM urine sediment 2023, event 1 a score of 100% was received. 2. Interview with Testing Personnel (TP) 2 on the Centers for Medicare/Medicaid Services,(CMS) Testing Personnel List(form 209) and the Laboratory Director on March 21, 2023 at approximately 12 am, in the nursing station, confirmed the aforementioned statements. -- 2 of 2 --