| 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 |
| D6086 | LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on a review of the implementation records for the Beckman Coulter (BC) DxH 690T Hematology analyzer, the BC Operation Qualification Checklist and an interview with General Supervisor (GS), the Laboratory Director (LD) failed to document review and approval (as indicated by a signature and date) of installation procedures verifying the manufacturer's performance specifications before patient testing began on 06-11-2024. This affected one of one new instruments installed in 2024. The findings include: 1. A review of the implementation records for the BC DxH 690T Hematology analyzer revealed the validation studies were not signed by the LD to indicate his review and approval of the following verification studies: A) Precision B) Carryover C) Accuracy and Calibration D) Calibration E) Linearity F) Mixing Studies 2. A further review of the validation records revealed only the Method Comparison was signed by the LD on 06-11-2024. 3. The Chief Operating Officer and the GS confirmed the above findings during the exit conference on 10-08-2025 at 4:28 PM. |