Valdosta State University- Student Health Center

Summary Statement of Deficiencies D0000 A recertification survey was performed on October 13, 2022. An entrance conference was held with the laboratory representatives. The survey process was discussed, along with review of the survey forms that was sent to the facility, previous to the survey. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided. The facility was found NOT to be in compliance with all applicable CLIA requirements for specialties/subspecialties for 42 CFR. 493.1255(b) Calibration and Calibration Verification procedures 493.1407(e)(3)(ii) Laboratory Directors Responsibilities NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 11, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on staff interview and the State Regulations, the laboratory is not in compliance with applicable State laboratory requirements Findings: 1. Interview with the Laboratory Manager by email on July 19, 2018 at 1:12pm, the Laboratory Manager stated that the facility did not have a state license as far as she new. 2. Review of the State Regulations for laboratories in the state of Georgia, the laboratory did not meet the Exemptions and should have applied for a state license. The exemptions are listed below. 111-8-10-.31 Exemptions. These rules and regulations shall not apply to: (a) Clinical laboratories operated by the Medical College of Georgia, the Emory University School of Medicine, Mercer University School of Medicine, Whorehouse School of Medicine, or any other medical schools in Georgia, or the United States Government; (b) Clinical laboratories operated and maintained exclusively for research and teaching purposes involving no patient or public health services; (c) Clinical laboratories operated by duly licensed physicians exclusively in connection with the diagnosis and treatment of their own patients; or (d) Pharmacists duly licensed in Georgia practicing in accordance with O.C.G.A. 26-4-4 as it pertains to the performing or capillary blood tests and the interpretation of the results of those tests as a means to screen for or monitor disease risk factors and facilitate patient education. The capillary blood tests allowed under this exemption shall be limited to 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 -- those capillary blood tests available to and for use by the public without licensure of the user of the test. Authority: O.C.G.A. 26-4-4 and 31-22-9. 3. Further review and investigations of the laboratory ownership and operations it was determined on August 10, 2018, that the facility was not in compliance with state regulations, and did not hold a current Georgia Laboratory License. -- 2 of 2 --