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 01D0300027 (X3) Date Survey Completed 07/28/2021
Name of Provider or Supplier Bibb Medical Center Street Address, City, State 208 Pierson Avenue, Centreville, 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
D2006 TESTING OF PROFICIENCY TESTING SAMPLES
CFR(s): 493.801(b)

The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing.


This STANDARD is not met as evidenced by:
Based on a review of the American Proficiency Institute (API) Proficiency Testing records and an interview with the General Supervisor, the laboratory failed to test the proficiency testing samples in the same manner as it tested patient specimens. This was noted on three out of eight 2018 - 2021 Chemistry - Core Proficiency Testing Events. The findings include: 1. A review of Proficiency Testing records revealed proficiency samples were performed twice before results were submitted to API. The samples were repeated, although they did not meet a repeat criteria. The following events had samples repeated: a) Chemistry - Core 2nd Event 2020: On 05/21/2020 the analytes were run on the UniCel DxC 600 used for patient testing (these were the results submitted to API) and a second run was performed on the UniCel DxC 600 (currently being validated). The API event cut off date was 06/01/2020. b) Chemistry - Core 3rd Event 2020: On 08/29/2020 the analytes were run on the UniCel DxC 600 used for patient testing (these were the results submitted to API) and on 09/09/2020 a second run was performed on the UniCel DxC 600 (currently being validated). The API event cut off date was 09/16/2020. c) Chemistry - Core 1st Event 2021: Amylase was out of reagent for UniCel DxC 600 used for patient testing, but the Amylase was run on the UniCel DxC 600 (currently being validated but not put in use for patient testing) and submitted to API. 2. During an interview on 07/27/2021 at 02:30 PM, the General Supervisor stated they were trying to validate the second UniCel DxC 600 and the instrument is currently not live for patient testing.