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 laboratory records, patient reports, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to perform method accuracy evaluations for histopathology frozen biopsy testing in 2023, affecting 13 biopsies. Findings include: 1. Upon review of laboratory procedures: a. under "Quality Assurance Program", it's stated, "Histopathology: .... All reading and reporting is performed by our physician. Proficiency testing is required for this service provided by our physician. It is suggested to submit 3 cases every 6 months to an outside Pathologist. The Pathology report is attached to and retained as a method for proficiency testing." b. under "Proficiency Testing", it's stated, "Upon receipt of the correspondance from the [external] dermatologist or dermatopathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician. If the diagnoses match, the reports are attached and placed in "Proficiency Testing" located in the quality control manual." 2. Review of patient testing logs revealed no documentation of bi-annual method accuracy for 13 histopathology frozen biopsies performed in 2023. Case: Date: 23B001 02/27/2023 23B002 03/23/2023 23B003 03 /23/2023 23B004 04/26/2023 23B005 04/27/2023 23B006 05/09/2023 23B007 05/23 /2023 23B008 07/10/2023 23B009 07/24/2023 23B010 08/22/2023 23B011 08/29 /2023 23B012 10/30/2023 23B013 10/30/2023 3. An interview with the LD at 09:51 am, on 03/13/2024, confirmed the above findings. 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 --