Valdosta Family Medicine Associates

Summary Statement of Deficiencies D0000 A recertification survey was performed on April 13, 2023 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 deficencies, but none were provided. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, in 2022, for the Speciality Immunology, the laboratory failed to verify the accuracy of the test kit for H pylori by successfully passing two PT events for the year. Findings: 1. Review of the API PT documents for 2022, Specialty Immunology, the laboratory received a score of 50% for event 1 for H pylori, and 50% for event 3 for H pylori. 2. Interview with the lab manager, on April 13, 2023 at approximately 3pm, in the facility conference room, confirmed the aforementioned statement. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) The laboratory director is responsible for the overall operation and administration of 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 -- the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for 2022, and staff interview, the laboratory failed to verify the Specialty Immunology, analyte H pylori, by receiving unsuccessful scores for event 1 and event 3 for the year. The Laboratory Director is responsible for the overall operation and administration of the laboratory. Findings: 1. Review of the API PT documents for 2022, Specialty Immunology, the laboratory received a score of 50% for event 1 for H pylori, and 50% for event 3 for H pylori. 2. Interview with the lab manager on April 13, 2023 at approximately 3pm in the facility conference room, confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 4, 2021. 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents, the laboratory failed to complete attestation statements for the PT testing performance in years 2019, 2020, and 2021. Findings: 1. Review of the APT PT testing documents for 2019, there were no attestation statements for the following events: Chemistry Core, events 1,2,3 Hematology/Coagulation, events 1,2,3 Microbiology, events 1,2 Immunology, events 1,2,3 Chemistry Misc, events 1,2 2. Review of the APT, PT testing documents for 2020, there was no attestation statements for the following events: Chemistry Core, events 1,2,3 Hematology /Coagulation, events 1,2,3 Microbiology, events 1,2 Immunology, events 1,2,3 Chemistry Misc, events 1,2 3, Review of the APT, PT testing documents for 2021 there was no attestation statements for the following events: Chemistry Core, events 1 Hematology/Coagulation, events 1 Microbiology, events 1 Immunology, events 1 Chemistry Misc, events 1 4. Interview with staff #2(CMS 209) on June 4, 2021 at approximately 2:30 pm, in the Conference Room, confirmed that there were no attestation statements for 2019, 2020, and 2021 for all specialties. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) provider documents, for the years 2019, 2020, 2021 the laboratory failed to document review of the PT scores for some of the events. Findings: 1. Review of the APT PT testing documents for 2019, the laboratory failed to show review for the following specialities: Chemistry Core, events 1 and 2 Hematology/Coagulation, events 1 and 2 Microbiology, events 1 and 2 Immunology, events 1 and 2 Chemistry Misc, events 1 and 2 2. Review of the API PT testing documents for 2020, the laboratory failed to show review for the following specialties: Chemistry Core, events 2 and 3 Hematology /Coagulation, events 2 Immunology, events 2 Chemistry Misc, events 1 and 3 3. Review of the APT PT testing documents for 2021, the laboratory failed to show review for the following specialties: Immunology, event 1 4. Interview with Staff #2 (CMS form 209), on June 4, 2023, at approximately 2:30 in the Conference Room, confirmed that there was no review documents for the above mentioned events for 2019, 2020, and 2021 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require