Savannah Medical Clinic

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 28, 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: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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 lack of quality control (QC) logs, observation during the laboratory tour, review of laboratory test package inserts, and staff interview, the laboratory failed to follow current manufacturer's instructions for all waived tests performed by the laboratory as required. Findings include: 1. Review of waived test package inserts and observation during the laboratory tour on 04/28/21 at approximately 11:00 a.m. revealed there were no required QC logs available at the time of survey for the following waived tests: Urine Human Chorionic Gonadotropin (hCG)(Henry Schein) and Microhematocrit (Clay Adams Readacrit) for 2019, 2020 or 2021 thus far. 2. An interview with staff #3 (CMS 209) in the lab at approximately 11:10 a.m. on 104/28 /2021 confirmed the lack of QC documents for the aforementioned waived tests for 2019, 2020, & 2021 thus far. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed onMarch 6, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of 2017 & 2018 personnel competency assessment records and staff interview , the laboratory director/technical consultant failed to include the six required competency assessment criteria when evaluating competency on testing personnel who test for the Rhesus factor (RH) also know as RH type. The findings include: 1. Review of testing personnel competency assessment records for 2017 & 2018 on 4 of 4 testing personnel revealed the assessment did not include the six competency assessment criteria required by CLIA. 2. Interview with the office administrator and testing personnel # 1 as well as TP # 2 (see CMS 209) in the office assigned to the surveyor on March 6, 2019 at approximately 4:00 PM confirmed 2017 & 2018 annual competency assessments did not contain the six criteria required by CLIA 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 --