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 review of validation records, review of laboratory test list, the absence of documentation, interview with laboratory director (LD) 12/05/24, and follow-up phone conference with general supervisor (GS) 12/18/24, the laboratory failed to verify the accuracy of the histopathology staining performed on the Ventana automated stainer at least twice a year since testing began in January of 2023, approximately 24 months. The laboratory also failed to verify accuracy of the pathology testing at least twice a year. 1. The laboratory failed to verify the accuracy of the histopathology staining performed on the Ventana automated stainer at least twice a year since testing began in January of 2023. Findings: Review of validation records revealed the laboratory began testing on the Ventana automated stainer in January of 2023. Review of test list for the Ventana automated stainer revealed the following stains are performed by the laboratory: 1. Anti-Pan Keratin 2. Ber Ep4 (antihuman epithelial antigen) 3. HPV HR (high-risk human papillomavirus) 4. CEA (serial plasma carcinoembryonic antigen) 5. CD 34 (cluster of differentiation 34) 6. CD 68 (cluster of differentiation 68) 7. Cd 138 (Syndecan-1) 8. CK-7 (cytokeratin 7) 9. CK-20 (cytokeratin 20) 10. Desmin 11. EMA (epithelial membrane antigen) 12. Factor XIIIa 13. HMB 45 (human melanoma black 45) 14. HSV I (herpes simplex virus 1) 15. HSV II (herpes simplex virus 2) 16. KI 67 (antigen Kiel 67 mitotic index) 17. P 16 (p 16 protein) 18. Melan A (melanocyte antigen) 19. PGP 9.5 (protein gene product 9.5) 20. P 40 (deltaNp63) 21. SM Actin (smooth muscle actin) 22. S 100 (soluble protein) 23. SOX 10 (SRY-box transcription factor 10) Review of laboratory records revealed no documentation the laboratory had performed a twice a year verification of accuracy for the testing performed on the Ventana automated stainer Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- since testing began in January of 2023. Follow-up phone conference with GS on 12/18 /24 confirmed the laboratory had not performed a verification of accuracy for the testing performed on the Ventana automated stainer since testing began in January of 2023. The GS also stated they were unaware of this requirement and many of the stains are rarely performed. 2. The laboratory failed to verify the accuracy of the pathology testing at least twice a year. Findings: Review of laboratory procedure "Professional Competency" revealed "PROCEDURE:...4. A Quality Assurance (QA) comparative table between the pathologist and the consultant pathologist diagnoses and have three types of comparative results: similar diagnosis, minor differences (insignificant), and major differences (significant). 5. The results for all the above will be evaluated and documented.