Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 01D0027697 (X3) Date Survey Completed 06/10/2021
Name of Provider or Supplier Auburn University Medical Clinic Laboratory Street Address, City, State 400 Lem Morrison Drive, Auburn, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies
D6013 LABORATORY DIRECTOR RESPONSIBILITIES
CFR(s): 493.1407(e)(3)(ii)

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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method;


This STANDARD is not met as evidenced by:
Based on a review of installation and validation records for the Healgen IgG and IgM SARs-COV-2 antibody testing and the Sysmex XN-530 Hematology analyzer, the surveyor determined the Laboratory Director (also the Technical Consultant) failed to ensure the studies performed proved accuracy, precision and reportable range, when necessary, for the new procedures implemented in the laboratory on July 30, 2020 and August 24, 2020, respectively. This affected two of two new procedures/equipment installed in the laboratory, since the previous survey (11/19/2018). The finding include: 1. A review of the validation records for the Healgen IgG and IgM SARs-COV-2 antibody testing revealed the laboratory ran 2 negative and 2 positive patients and sent them to a local hospital for a comparison. (The surveyor reviewed a file folder with approximately 10 patient test results but was unable to determine with what these were compared to). The surveyor inquired of the laboratory supervisor how accuracy of testing was proven. This is when the laboratory supervisor reviewed the file and was able to find the 2 negative and 2 positive comparison study. There was no summary of accuracy and no laboratory director's signature to indicate he had reviewed and approved implementation of the testing. Patient testing began July 30, 2020. 2. A review of the installation and validation records for the Sysmex XN-530 revealed a carryover, precision and accuracy, and a reportable range study was done 8/5/2020. There was no signature by the Laboratory Director (who is also the Technical Consultant) to indicate the data had been evaluated to ensure the performance specifications by the manufacturer had been proven. Patient testing began August 24, 2020.