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 document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2021. Findings are as follows: 1. The laboratory performed Histopathology tissue analysis as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:15 a. m. on 05/26/22. 2. Twice annual tissue analysis accuracy verification was not found for 2021 during review of laboratory records. The laboratory was unable to provide the missing accuracy verification documentation upon request. 3. A slide exchange with peers was required twice within the CLIA inspection cycle as established in the Proficiency Testing procedure located in the Protocols and Procedures Manual. This frequency does not meet the minimum required by CLIA at 42 CFR 493.1236 (c)(1). 4. The laboratory performed Histopathology tissue analysis on approximately 3400 cases annually as indicated on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 11:15 a.m. on 05/26/22, the LD confirmed the above finding. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --