Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 09/04/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and testing person #1 at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of policies and procedures and interview with the technical consultant, the written competency assessment policy did not define the frequency of the assessments for the technical consultant based on the position responsibilities for one of one technical consultant. Findings include: (1) A review of the competency assessment policy titled, "Technical Consultant Job Description" identified it did not define the frequency of the assessments; (2) Interview with the technical supervisor on 09/04/2025 at 10:39 am confirmed that although the competencies based on the position responsibilities of the technical consultant had been performed annually, the policy did not define the frequency of the assessments. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of five Hematology Proficiency testing events reviewed in 2024 and 2025. Findings include: (1) A review of Hematology Proficiency testing records for five events (First 2024, Second 2024, Third 2024, First 2025, and Second 2025) identified the following failure with no evidence that