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 record review and interview with the Laboratory Director, the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination for TP1 (testing personnel). The laboratory performs approximately 200 histopathology slide examinations annually. Findings include: 1. Record review revealed that the laboratory failed to verify the accuracy, at least twice annually, of their test system for histopathology slide examination for TP1 since the last survey which was performed on 1/16/2024. 2. In an interview on 6/05/2025 at approximately 11:10 am, the Laboratory Director confirmed the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 direct observation and interview with the Laboratory Director (LD), the laboratory failed to ensure that the Chlorazol Black E reagent was not used past the expiration date. The laboratory performs approximately 60 KOH tests annually. 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 -- Findings Include: 1. Direct observation revealed the Chlorazol Black E reagent, lot number 2343, had an expiration date of 2024/12/09. 2. Interview with the LD at 11:15 AM on 06/05/2025 confirmed the Chlorazol Black E reagent was used for patient testing past the expiration date. -- 2 of 2 --