Access Health Rural Acres Clinic

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted January 7, 2026, at Access Health Rural Acres Clinic by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficient practices cited are explained below. D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of hematology policies and procedures, complete blood count (CBC) test reports from the Orchard Harvest laboratory information system (LIS), lack of documentation, and an interview with the technical consultant (TC1), the laboratory failed to document the notification to the ordering providers for 6 of 30 alert value results released in November 2025. Findings: 1.. Review of "Laboratory Policies and Procedures" identified "Alert Values" for hematology analytes and the process to document the notification to the ordering provider of the alert value. The analyzer manual stated the following reference intervals: a. White blood cell count (WBC) 4.8- 10.8 K/uL for an adult ,4.5-15.5 K/uL for a person less than 18 years old, WBC results below 3.0 and greater than 15.0 K/uL are alert values b. Hemoglobin (HGB) 14.0-18.0 g/dL for an adult male, 12.0-16.0 g/dL for an adult female, 10.0-15.5 g/dL for a person less than 18 years old, HGB results below 9.0 and greater then 22.0 g/dL are alert values 2. Review of 79 complete blood count (CBC) hematology results from the Orchard Harvest LIS from November 2025, revealed alert values released for 30 patients. The following 6 of 30 patients had alert values released and no documentation of the notification to the ordering provider in the LIS: Patient ID 1123933 WBC 2.9 K/uL on 11/3/2025 Patient ID 645828 WBC 2.9 K/uL on 11/7 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- /2025 Patient ID 648634 HGB 8.9 g/dL on 11/6/2025 Patient ID 586835 WBC 2.9 K /uL on 11/3/2025 Patient ID 1141204 WBC 0.832 K/uL on 11/19/2025 Patient ID 695782 WBC 17.3 K/uL and HGB 7.4 g/dL on 11/20/2025 3. During an interview on 1/7/26 at 11:00 am, TC1 verified the lack of documented provider notification for the 6 patients with alert (critical) values. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Access Health Rural Acres Clinic on January 31, 2024, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)