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
D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT
CFR(s): 493.1252(a)

(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under ยง493.1253.


This STANDARD is not met as evidenced by:
Based on review of the Coagulation ACL Top analyzer's Policy and Procedures (P&P) for the Normal Prothrombin Time (PT)/International Normalized Ratio (INR) and an interview with the Chief Operating Officer and the General Supervisor (GS), the laboratory failed to follow the specimen requirements in the collection of patient samples used for the calculation of the normal patient PT mean. The surveyor noted an incorrect mean was utilized in the calculation of the INR in use for patient testing for approximately five of the ten months reviewed in 2025. The findings include: 1. A review of the P&P for the PT/INR calculation revealed specimens utilized in the calculation of the normal patient PT mean should be from individuals meeting the following criteria: a) No anticoagulant use b) No birth control or hormone replacement therapy c) The Citrate Blue Top collection tube must be filled to the correct level 2. A review of the normal patient PT mean study results revealed three of the twenty specimens had PT results outside the laboratory's normal range and were not excluded when calculating the normal mean. 3. The Chief Operating Officer and the GS confirmed the above findings during the Day 2 exit conference on 10-08-2025 at 4:28 PM.