Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to retain records for one of three proficiency testing events in 2023. The findings include: 1. A review of the laboratory's API PT records revealed no records available for the 2023 Hematology third event. 2. An interview with the Regional Operations Manager on 04.03.2025 at 10:00 a.m. confirmed the above survey findings. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers for Medicare & Medicaid Services Laboratory Personnel Report (FORM CMS-209), personnel records, and staff interviews, the laboratory director failed to define the duties and responsibilities of the Regional Operations Manager (one of two technical consultants). The 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 2 -- include: 1. A review of the FORM CMS-209 revealed the Regional Operations Manager is one of two technical consultants (TC2). 2. A review of the laboratory's personnel records revealed no job description or list of duties and responsibilities defined for the Regional Operations Manager. 3. Interviews with the Regional Operations Manager and Technical Consultant on 04.03.2025 at 11:30 a.m. confirmed the above survey findings. -- 2 of 2 --