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 03/13/2025
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
D5481 CONTROL PROCEDURES
CFR(s): 493.1256(f)(g)

(f) Results of control materials must meet the laboratory’s and, as applicable, the manufacturer’s test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed.


This STANDARD is not met as evidenced by:
Based on a lack of documentation of the Abbott i-STAT Respiratory analyzer quality control (QC) records, and an interview with the General Supervisor, the laboratory failed to document QC on the i-STAT respiratory analyzer. This was noted for 23 months of 26 months reviewed in 2023-2025. The findings include: 1. A review of the records for the Abbott i-STAT Respiratory analyzer revealed no evidence of QC documentation from January 2023 through November 2024. 2. During an interview on March 12, 2025, at 12:02 PM, the GS confirmed the Respiratory Manager could not provide documentation.