Summary:
Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: By personnel interview and review of the record, the laboratory failed to maintain sufficient supplies to perform proficiency testing for Chemistry proficiency, in one of 3 API 2020 events. Findings. 1. 2020 API Event # 3 - failed PSA with a score of (0%); 2. 2020 API Event # 3 - failed Testosterone with a score of (0%); 3. During the survey (15:00 09/16/2021), the Laboratory Supervisor confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on laboratory record review and interview with the Laboratory Director and Laboratory Supervisor on the date of the survey, the laboratory failed to verify twice annually the accuracy of Urine Cytology and Florescence In Situ Hybridization(FISH) examinations preformed from 06/20/2019 through the date of survey. Findings include: 1.The Laboratory could not provide documentation of twice annual accuracy, for UrineCytology and FISH examinations, from 06/20/2019 through the date of the survey 2. During the survey, the Laboratory Director confirmed the above finding. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --