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
D6107 LABORATORY DIRECTOR RESPONSIBILITIES
CFR(s): 493.1445(e)(15)

(e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.


This STANDARD is not met as evidenced by:
Based on reviews of personnel records, the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the General Supervisor (GS), the Laboratory Director (LD) failed to specify in writing which of the LD's duties and responsibilities were assigned to a designee. The surveyor noted there was no written documentation for the designation of authority from the date of the last survey, 08-24-2023 to the date of the current survey, 10-08-2025. The findings include: 1. A review of personnel records revealed the LD had no documentation authorizing a qualified designee to perform certain duties and responsibilities in all phases of the laboratory testing process. 2. A review of the API PT records revealed Testing Personnel #1 had signed the following PT attestation events. a) 2023 Chemistry Core, Chemistry Miscellaneous, Hematology, Microbiology, Immunology and Immunohematology 3rd events. b) 2024 Hematology 1st event c) 2024 Immunology and Immunohematology 1st event 3. At approximately 11:10 AM on 10-07-2025, the GS presented the surveyor a designation of authority document, however the LD's signature did not match with the LD's signature on the CMS 116 and 209 forms submitted during the previous survey on 08-24-2023.