Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to self evaluate the Proficiency Testing (PT) scores graded as educational challenge as required by the College of American Pathologist (CAP) in the specialty of Hematology. Findings include: 1. Record review on 7/24/2024 of the CAP's PT summary report for FH13-B 2023 Hematology Auto Differentials, FH13 revealed the following: a. "Actions laboratories should take when a PT result is not graded. Your laboratory must identify all of the analytes with all Exception Reason Code and investigate the acceptability of performance." b. " Code 26: Educational challenge: Action Required: Response to CAP not required. Laboratory should document its review." 2. Record review on 7/24 /2024 of three PT "Original Evaluation" reports from CAP revealed the lack of documentation of investigation and review for exception reason code [26] for the following PT surveys: a. BCP-A 2024 Blood Cell ID, Photographs. b. FH13-B 2023 Hematology Auto Differentials, FH13. c. FH13-C 2023 Hematology Auto Differentials, FH13. 3. Staff interview with the Laboratory Administrative Director (LAD) on 7/24/2024 at 10:30 AM confirmed that PT evaluations with exception reason codes [26] were not investigated and documented by the Medical Laboratory Director or the designee. 4. The laboratory performs 23,766 tests annually in the specialty of Hematology. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- effectiveness of