Summary:
Summary Statement of Deficiencies 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: Based on surveyor review of the laboratory proficiency testing records, Centers of Medicare and Medicaid Services (CMS) database proficiency testing report and confirmation with the technical consultant at 1:00 pm on 5/1/19, the laboratory director failed to ensure the laboratory was enrolled and participated in an HHS approved proficiency testing (PT) program for CBC (complete blood count) performed on the Sysmex XP 300 hematology analyzer for the first testing event of 2019. The laboratory director must ensure the laboratory is enrolled and participates in all 3 events in an approved proficiency program for the testing performed by the laboratory. Findings include: 1. Observation of the CMS database proficiency testing report revealed no scores for the 1st event of 2019. 2. Observation of laboratory records since installation of Sysmex XP 300 on 12/27/18 through the day of survey, 5 /1/19, revealed no evidence of proficiency testing enrollment prior to survey. 3. Interview with technical consultant at 1:00 pm on day of survey and observation of recent proficiency enrollment forms revealed the laboratory did not enroll in proficiency in time to participate in the 1st event of 2019 when installation of analyzer was 12/27/18 and testing began 1/7/19. 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 --