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 01D0027451 (X3) Date Survey Completed 10/08/2025
Name of Provider or Supplier Grove Hill Memorial Hospital Street Address, City, State 295 S Jackson St, Grove Hill, 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 reviews of the Beckman Coulter (BC) AU 700 Chemistry analyzer calibration and Quality Control (QC) records, and an interview with the General Supervisor (GS), the laboratory failed to fulfill CLIA Calibration-Verification (C-V) regulatory requirements by performing three levels of QC twice a day or implementing C-V procedures at least every six months. The surveyor noted no documentation of five of the five C-Vs due during the August 2023 through August 2025 review period. The findings include: 1. A review of the calibration records for the BC AU 700 analyzer revealed analytes included in the Complete Metabolic Panel, Lipid Panel, Renal Panel, Hepatic Panel and other Chemistry regulated analytes including Amylase, Lactate Dehydrogenase, Cholesterol LDL, Iron, Magnesium, Phosphorus, and Uric Acid were calibrated with less than three calibrators. 2. A review of the procedures in use during the previous survey period revealed the laboratory had opted to perform three levels of QC twice a day in lieu of performing calibration verification on analytes utilizing less than three calibrators. 3. However, a review of the 2023-2025 QC records revealed days when QC on the BC AU 700 for the above listed analytes was only performed once each day of testing, with no implementation of calibration verification procedures utilizing three or more C-V samples. 4. During the Day 2 exit conference on 10-08-2025 at approximately 4:28 PM, the GS confirmed the above findings, and stated there were days when the laboratory could only perform one QC run due to a limited supply of QC materials from the manufacturer.