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 a review of proficiency test verification records and an interview with the laboratory director, the laboratory failed to verify the accuracy of the fungal test procedure. Findings Include: On May 8, 2018, at approximately 11:15 AM the laboratory director confirmed that the laboratory failed to perform twice annual verification for the fungal culture procedure performed for the year 2017. Approximately 164 patient specimens were tested and reported for the fungal culture procedure performed. 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. This STANDARD is not met as evidenced by: Based on a review of records, surveys observation and an interview with the 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 -- laboratory director on May 8, 2018, at approximately 11:15 am, the laboratory director failed to ensure that the QA program for the fungal cultures were maintained to ensure quality laboratory services. Refer to: D5217 -- 2 of 2 --