Summary:
Summary Statement of Deficiencies D0000 An onsite survey was completed on August 29, 2025, to investigate complaint number GA00255886. The allegation was substantiated. The following deficiencies were cited: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation during the laboratory tour and staff interview, the laboratory failed to establish Standard Operating Procedures (SOPs) or modified manufacturer's instructions for all waived tests performed by the Clinic's laboratory as required from July 2023 to August 2025. Findings: 1. Observations during the laboratory tour on 08 /29/2025 at approximately 10:40 a.m. revealed there were no SOPs (Standard Operating Procedures) manuals or modified manufacturer's instructions available to guide testing personnel for the following waived tests: Dip stick Urinalysis, pregnancy tests(Urine HCG) and finger sticks for point of care glucose and hemoglobin checks. 2. Documents maintenance review on 08/29/2025 at approximately 1:00 PM revealed there were no required daily Quality Control (QC) documentations on all in-house testing in this location from July 2023 to August 2025. 3. No documentations of laboratory's room temperatures, refrigerator temperatures and humidity during daily testing from July 2023 to August 2025. 4. No policies on specimen collection, handling, transportation and resulting guidelines for testing personnel.as of 08/29 /2025. 5. An Interviews with staff and laboratory director at approximately 5:30 PM. on 08/29/2025 confirmed the lack of laboratory (SOPs), Quality Control (QC) documentations, refrigerator and room temperature monitoring for the aforementioned waived tests from July 2023 through day of survey 08/29/2025. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --