Summary:
Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual (PM), Biannual Assessment (BA) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy and reliability of Moh's testing twice a year from 8/10/21 until the date of survey. The finding includes: 1. The BA assessments did not have documented proof the reviewing physician was qualified to participate in the BA. 2. The TP confirmed on 7/12/23 at 1:30 pm that the laboratory did not verify the accuracy of Moh's testing twice a year. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the Flammable Cabinet and interview with the Testing Personnel (TP), the laboratory used expired 95% Reagent Alcohol for Histopatholgy testing from 5-31-2023 to the date of survey. The findings include: 1) StatLab 95% Reagent Alcohol lot # 122818 expired 5/31/23. 2) Approximately 35 patient were run and reported. 3) The TP confirmed on 7/12/23 at 1:30 pm that the laboratory used expired reagent. 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 --