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
D5439 CALIBRATION AND CALIBRATION VERIFICATION
CFR(s): 493.1255(b)

(b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under ยง493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.


This STANDARD is not met as evidenced by:
Based on a lack of i-STAT calibration verification (C-V) records and an interview with the General Supervisor, the laboratory failed to ensure C-V was documented on the Abbott 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 C-V 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.