Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found a CFR 42 493.1 through 493.1780: 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel. 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: Review of Immunohematology proficiency testing records for 2022 and interview of facility personnel found the laboratory failed to ensure that proficiency testing results were reviewed and evaluated for one of one testing events. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records for 2022 found no documentation of the review of the 2022 Immunology /Immunohematology 1st event. The performance Review page had no date of review or signature of reviewer. 3. Interview of testing person one on the CMS Laboratory Personnel Report conducted June 21, 2022 at 10:37 AM confirmed the laboratory did not evaluate results in this event stating she assumed that they did not have to be reviewed if they did not fail the event. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are 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 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require