Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the proficiency test verification records and an interview with the laboratory testing person, the laboratory failed to verify the accuracy of the interpretation of results for the Biofire Film array GI and Respiratory Panel. Findings Include: 1) On February 27, 2018, at approximately 11:30 AM and confirmed by the laboratory testing person, the laboratory failed to perform twice annual verification for the Biofire Film Array GI panel for year 2017. The testing person stated that she did not realized the laboratory did not receive the PT specimens for the GI Panel. Approximately 551 patient specimens were tested and results reported for the GI panel during that time. 2) On February 27, 2018, at approximately 11:45 AM and confirmed with the laboratory testing person, the laboratory failed to perform twice annual verification for the Coronavirus. Approximately 32 patient specimens were tested and results reported for the Coronavirus during that time. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 -- This STANDARD is not met as evidenced by: Based on a review of records, surveys observation and an interview with the laboratory testing person on February 27, 2018 at approximately 11:30 AM, the laboratory director failed to ensure that the QA program for the GI Panel (bacteriology, parasitology, and virology) and the Respiratory testing was maintained to ensure quality laboratory services. Refer to: D5217 -- 2 of 2 --