Summary:
Summary Statement of Deficiencies 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: Based on the surveyor's review of College of American Pathologists (CAP) Proficiency Testing (PT) records and confirmed in an interview with the laboratory's technical consultant, the laboratory failed to evaluate and document the review of the laboratory's scored PT results. FINDINGS: On the date of survey, at approximately 3: 00 pm, the technical consultant confirmed that there was no evidence of PT review, by the laboratory director, of the scored results for the second and third events of 2017 and all three events of 2018. 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 reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require