Vidalia Medical Associates

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 25, 2022. 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: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) the laboratory failed to successfully participate in the 3rd event of 2021, and the 1rst event of 2022, for the Speciality Chemistry, Subspecialty Carbon Dioxide (CO2) for 2 out of 3 events. Refer to: D2096 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory failed to successfully participate in 2021, 3rd event and the 1rst event of 2022, for the Speciality Chemistry, Subspecialty Carbon Dioxide (CO2) for 2 out of 3 events. Findings: 1. Review of the API PT documents for the year 2021, 3rd event and 2022 1rst event, for the Specialty Chemistry, subspecialty, Carbon Dioxide (CO2), the laboratory failed to successfully participate with successful results. In 2021, 3rd event the laboratory scored 60% out of 100% . In 2022, 1rst event the laboratory scored 0% out of 100%. 2. Interview with staff #2, 3 and 4, (CMS form 209) on August 25, 2022 at approximately 2pm in the conference room, confirmed the aforementioned statement. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory Director (LD) failed to address the unsuccessfull participation in 2021, 3rd event and the 1rst event of 2022, for the Speciality Chemistry, Subspecialty Carbon Dioxide (CO2) for 2 of 3 events. Findings: 1. Review of the API PT documents for the year 2021, 3rd event and 2022 1rst event, for the Specialty Chemistry, subspecialty, Carbon Dioxide (CO2), the laboratory failed to successfully participate with successful results. In 2021, 3rd event the laboratory scored 60% out of 100% and in 2022, 1rst event the laboratory scored 0% out of 100%. 2. Interview with staff #2, 3 and 4, (CMS form 209) on August 25, 2022 at approximately 2pm in the 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 November 20, 2020. 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on laboratory maintenance document review and staff interview, the laboratory failed to observe safety procedures to ensure protection from physical chemical and biohazardous materials as required. Findings include: 1. Laboratory maintenance document review revealed the lack of eyewash equipment maintenance documents available at the time of survey for the following dates: 2018 -- September through December; 2019, and 2020 thus far. 2. An interview with the laboratory manager in the conference room on 11/2/2020 at approximately 4:45 p.m. confirmed the lack of eyewash equipment maintenance for the aforementioned dates. 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 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, review of the Laboratory Personnel Report form (CMS 209) and staff interview, the laboratory failed to rotate testing of PT samples among all testing personnel who test patient samples. Findings include: 1. Review of the CMS 209 revealed 2 employees listed as testing personnel. 2. Review of PT attestation statements for 2017 and 2018 revealed testing personnel # 1 signed all PT attestations in 2017 and 2018. 3. Interview with testing personnel # 1 and the laboratory manager (see CMS 209) in the conference room on August 21, 2018 at 4 pm confirmed testing personnel # 2 test patient samples but has not participated in testing PT samples. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be 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 -- established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017 and 2018 quality control (QC) records for testing performed on the TOSOH A1A 900 endocrinology analyzer and the Dimension Expand chemistry analyzer , review of