Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the twice per year verification records and an interview with the laboratory director/technical supervisor, the laboratory failed to verify the accuracy of interpretation of pathology slides when major diagnostic discrepancies were identified for two pathology cases in calendar year 2018. Findings include: 1. To fulfill the twice per year verification requirement, the laboratory had submitted random pathology slides to another independent qualified pathologist for review. 2. On November 7, 2018 at approximately 11:00 AM the laboratory director confirmed survey's findings that the second pathologist reviewer disagreed with the original pathologist's diagnostic findings for the two following cases: 60 TS 18 - 206 60 TS 18 - 358 3. The laboratory has a written policy/procedure for peer review discrepancies that defines criteria for