Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2023 and 2024 CAP (College of American Pathologists) proficiency testing records 9/11/24, the testing personnel failed to attest that proficiency samples were tested in the same manner as patient specimens are routinely tested for 3 of 6 proficiency testing events. Findings: Review of the "Quality Ambulatory Assurance Plan Point of Care Testing" revealed "... C. Proficiency Testing: ... Attestation statements are signed by testing personnel and Lab Director/designee. ..." Review of 2023 and 2024 CAP proficiency testing records revealed testing personnel failed to sign attestation statements for the following events: 1. 2023 CM-A; 2. 2023 CM-B; 3. 2023 SEM-A. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. 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 3 -- Based on review of job descriptions and review of 2023 and 2024 CAP proficiency testing records 9/11/24, the laboratory director failed to ensure the laboratory was enrolled in an approved proficiency testing program for the testing performed. Findings: Review of the "Technical Consultant for Moderate Complexity Lab" job description revealed "... The Urology Technical Consultant position is served by the Lab Director. ..." The job description included a list of duties for the technical consultant (laboratory director), including "Enrolls the laboratory in an approved PT program." Review of 2023 and 2024 CAP proficiency testing records revealed the laboratory was not enrolled in proficiency testing for the first clinical microscopy, urinalysis, and semen analysis test events of 2024. Review of the laboratory's 2024 proficiency testing order revealed the laboratory enrolled 7/11/24 after the lapse was discovered. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved