Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 03/12/2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard-level deficiencies were cited. 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 review of Proficiency Test (PT) records and interview with the Testing Personnel #2 (TP2), the laboratory failed to verify the accuracy of Histology testing for two of two required assessments in 2024. Findings: 1. In reviewing PT records for years 2024 and 2025, there was no documentation for verification of accuracy for Histology testing in 2024. 2. In an interview on 03/12/2026 at 10:00 AM, TP2 confirmed accuracy assessment for Histology testing did not start until 2025 and no assessments were completed in 2024. 3. Annual test volume for Histology = 14,080. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the Pathology-Histology Microtomy Specimen Processing 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 -- procedure, review of Histopathology slides, and an interview with the Testing Personnel #2 (TP2), the laboratory failed to follow its own procedure for labeling slides for three of three patient cases. Findings: 1. A review of the Pathology- Histology Microtomy Specimen Processing procedure identified the following required information be included when labeling slides: a. "Patient's name b. Appropriate surgical numbers (as noted on blocks) - e.g. S-08-001 c. Level Number - e.g. L-1, L-2, L-3 d. And other pertinent information" 2. Three randomly selected patient cases were reviewed: Accession number: S24-00429 Slide label included: S24- 00429 Levels 1-3, 2AB, 2 Colony No patient name on slide label Accession number: S25-00460 Slide label included: S25-00460 Levels 1-3, 2AB, 2 Trich No patient name on slide label Accession number: S26-00108 Slide label included: S26-00108 Levels 1-3, 2AB, 2 Giemsa No patient name on slide label 3. In an interview on 03/12 /2026 at 12:15 PM, TP2 confirmed the laboratory failed to follow their own procedure for labeling slides. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on laboratory observation, review of instrument operator manual's, room temperature logs, and interview with the Testing Personnel #2 (TP2), the laboratory failed to define an acceptable room temperature range based on instrument manufacturer's operating requirements for 12 of 12 months in 2025. Findings: 1. During a tour of the laboratory on 03/12/2026 at 12:30 PM, the following instruments used for patient specimen testing were observed: Tissue-TeK VIP 5 Serial Number: 52140237 Rotary Microtome HM 325 Serial Number: 5117 Tissue-Tek TEC 6 Embedding Module Serial Number: 51080107-0918 2. A review of the operator manuals for each the instruments identified above revealed the following manufacturer's room temperature requirements for operation: Tissue-Tek VIP 5 Room temperature requirement = 10 C to 40 C Rotary Microtome HM 325 Room temperature requirement = 5 C to 35 C Tissue-Tek TEC 6 Embedding Module Room temperature requirement = 10 C to 35 C 3. A review of randomly selected laboratory room temperature log sheets from January to December 2025 revealed the following: "Acceptable Temperature Range: Personal Preference." 4. In an interview on 03/12 /2026 at 10:25 AM, TP2 confirmed the laboratory failed to define an acceptable room temperature range based on instrument manufacturer's operating requirements. -- 2 of 2 --