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
D5781 CORRECTIVE ACTIONS
CFR(s): 493.1282(b)(1)

(b) The laboratory must document all corrective actions taken, including actions taken when any of the following occur: (b)(1) Test systems do not meet the laboratory's verified or established performance specifications, as determined in ยง493.1253(b), which include but are not limited to-- (b)(1)(i) Equipment or methodologies that perform outside of established operating parameters or performance specifications; (b)(1)(ii) Patient test values that are outside of the laboratory's reportable range of test results for the test system; and (b)(1)(iii) When the laboratory determines that the reference intervals (normal values) for a test procedure are inappropriate for the laboratory's patient population.


This STANDARD is not met as evidenced by:
Based on a review of temperature logs and an interview with the General Supervisor, the laboratory failed to document corrective action when temperatures were not within acceptable limits. This was noted 18 days reviewed from January 2019 to June 2021. The findings include: 1. A review of temperature logs revealed the following days were outside of established range without corrective action documented: a) Refrigerator #1 (2 - 8 degrees Celsius) 1) 04/09/2020 - 8.5 degrees Celsius 2) 04/10/2020 - 8.6 degrees Celsius 3) 04/11/2020 - 8.1 degrees Celsius 4) 04/13/2020 - 8.3 degrees Celsius 5) 04/14/2020 - 8.5 degrees Celsius 6) 04/21/2020 - 8.1 degrees Celsius 7) 04/22/2020 - 8.1 degrees Celsius b) Refrigerator #2 (2 - 8 degrees Celsius) 1) 01/21/2020 - 8.1 degrees Celsius 2) 04/13/2020 - 8.2 degrees Celsius 3) 04/14/2020 - 9.0 degrees Celsius 4) 04/24/2020 - 8.1 degrees Celsius c) Freezer (< -20 degrees Celsius) 1) 06/10/2020 to 06/16/2020 range between -19 and -18 degrees Celsius 3. During an interview on 07/28/2021 at 12:30 PM, the General Supervisor stated corrective action should have been documented when temperatures were recorded outside of established ranges and confirmed the above dated did not have corrective action documented.