Summary:
Summary Statement of Deficiencies D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, the QC program, patient records and interview with the technical consultant, the laboratory director failed to maintain the QC program for monthly testing of positive and negative external QC materials for troponin testing. The laboratory did not perform external QC for three of twelve months during 2019. Findings: 1. Review of QC records for 2019 showed the laboratory performed positive and negative QC materials for troponin testing on May 15, 2019 and not again until September 12, 2019. 2. Review of the QC program showed the technical consultant or laboratory director must verify external positive and negative QC materials are performed each month. 3. Review of patient records showed the laboratory performed six troponin tests between May 15, 2019 and September 12, 2019. 4. Interview with the technical consultant on March 16, 2021 at 08:20 AM confirmed the laboratory director failed to ensure positive and negative external QC materials were performed each month. 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 --