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 Biannual Assessments (BA) records and interview with the Laboratory Manager (LM), the laboratory failed to verify the accuracy of Histopathology testing biannually from 1/1/24 to 9/30/25. The finding includes: 1. There was no documented evidence the laboratory verified the accuracy of histopathology testing in calendar year 2024. 2. The LM confirmed on 9/23/25 at 1:30 pm, the laboratory did not verify the accuracy of Histopathology testing in calendar year 2024. 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 surveyor observation of Tissue Marking Dyes and Reagents and interview with the Laboratory Manager (LM), the laboratory used and failed to discard expired Tissue Marking Dyes (TMD) used for Histopathology testing from 11/30/21 to 9/30 /25. The findings include: 1. Surveyor observation of the TMD revealed the following to be expired: a) One Green TMD Lot# 090707 expired on 11/30/21. b) One Red TMD Lot# 089941 expired on 11/30/21. c) One Black TMD Lot# 091345 expired on 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 -- 12/31/21. d) One Yellow TMD Lot# 092723 expired on 1/31/22. e) One Blue TMD Lot# 092713 expired on 1/31/22. 2. Approximately 800 tests were performed and reported with expired TMD. 3. The LM confirmed on 9/30/25 at 1:20 pm, the laboratory used and failed to discard expired TMD for Histopathology testing. -- 2 of 2 --