Rockdale Family Practice

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 21, 2023. 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 review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to ensure a policy for the eyewash station. Findings include: 1. SOP review revealed the laboratory failed to establish an eyewash procedure for safety of the testing personnel. 2. The laboratory performed eyewash maintenance on a weekly basis and there was a documented log. 2. During an interview with the Practice Manager and Testing Personnel #3(CMS-209) on June 21, 2023 in the breakroom, confirmed there was not an eyewash procedure present, during the time of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: Based on laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow the required 6-step criteria competency for 7 out of 7 Testing Personnel (TP). Findings include: 1. Competency document review revealed the laboratory was performing competency, but failed to follow the required 6-step criteria policy and procedure for all Testing Personnel (TP) listed on the CMS-209 form. 2. During an interview with the Practice Manager and Testing Personnel #3 (CMS-209) on June 21, 2023 at 11:30 AM, in the breakroom, confirmed that competency was performed for all Testing Personnel (TP), but the laboratory failed to follow the required 6-step criteria for competency. 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 the laboratory's testing personnel competency assessment checklist and staff interview, the Technical Consultant failed to ensure the competency assessment policy and procedure for testing performed, in the speciality of hematology and chemistry, met the 6 required criteria, and failed to perform the assessment on 7 out of 7 testing personnel.. The Findings include: 1. Competency document review revealed the Technical Consultant (TC) failed to perform the 6 required criteria for hematology and chemistry for 7 out of 7 Testing Personnel. 2. During an interview with Testing Personnel #1 (CMS-209) on June 21, 2023 at 11:30 AM, in the breakroom, confirmed the Technical Consultant failed to perform the 6 required criteria for competency. -- 2 of 2 --

Summary Statement of Deficiencies D0000 On October 6, 2021 an off site follow-up review was completed. The report revealed that

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 20, 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: 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 observation and interviews with the laboratory coordinator and clinic administrator, the laboratory failed to implement and established safety procedure to ensure protection from physical, biochemical, and biohazardous materials. Findings include: 1. During the laboratory tour it was observed there was not a maintenance log for the eyewash equipment in the laboratory testing area. 2. An interviews with the laboratory coordinator and clinic administrator during the laboratory tour on 03/20 /2019 at approximately 10:30 a.m. confirmed the eyewash equipment had no maintenance log. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)