Augusta Oncology Associates

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 18, 2023. The labratory 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 Standard Operating Procedure (SOP) and staff interview, the laboratory failed to establish a safety procedure for the eyewash. The Findings include: 1. SOP document review revealed that the laboratory failed to establish a safety procedure for the sink eyewash in the laboratory. The laboratory does perform weekly flushing of the sink eyewash and document. 2. During an interview with Testing Personnel#1 (CMS-209) on January 18, 2023, at approximately 1:10 PM, in the conference room, confirmed that the laboratory failed to establish a safety procedure for the eyewash. The laboratory does have documention of the weekly flushing of the sink eyewash. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions 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 -- for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing. The findings include: 1. A review of the SOP confirmed that a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, and how to obtain additional assistance) was not available for staff to follow when sending specimens to a reference laboratory. 2. During an interview, on January 18, 2023, at 1:20 PM, with Testing Personnel#1 (CMS-209), in the conference room, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to reference laboratories. D5779

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 17, 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: 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 proficiency test (PT) document review and interviews with TP #3 (CMS 209) and the clinic's administrator, the laboratory failed to rotate testing personnel (TP) for PT testing in the specialties of Hematology/coagulation and Chemistry for 2017 and 2018. Findings include: 1. American Proficiency Institute (API) PT document review and staff interview revealed that, the same testing personnel ( TP # 2, #3 ) tested all PT samples. TP #s 4 through # 7 did not participate in PT testing in 2017 and 2018. 2. An interview with Staff #3 ( CMS 209) and the clinic's administrator in the conference review room on 10/17/2018 at approximately 01:00 pm confirmed only TP #2 and #3 tested all PT samples in 2017 and 2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 the review of laboratory maintenance records and interviews with TP #3 (CMS 209) and the clinic's administrator, the laboratory failed to calibrate the Horizon Model 642 Mini E centrifuge Bi-annually per manufacturer's recommendations. Findings include: 1. Observation during the laboratory tour revealed the LabCorp Horizon model 642 Mini E centrifuge was last calibrated on October 23, 2015. 2. An interview with TP # 3 (CMS 209) and clinic's administrator October 17, 2018 in the conference review room at approximately 01:18 PM, confirmed the centrifuge had not been calibrated since 10/23/2015. 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 personnel records and interviews with both TP # 3 (CMS 209) and the clinic's administrator, the laboratory's Technical Consultant(TC) failed to include the six required competency assessment criteria when evaluating annual competency on testing personnel in 2017 and 2018 for the specialties of Hematology/ Coagulation and Chemistry. The findings include: 1. Review of testing personnel (TP #s 2 - 7 on CMS 209) competency assessment records for 2017 and 2018 revealed the assessment did not include the six competency assessment criteria required by CLIA. 2. An interview with TP # 3 (CMS 209) and the clinic's administrator in the conference review room on October 17, 2018 at approximately 01:20 PM confirmed that annual competency assessment for testing personnel (TP#s 2-7, CMS 209) did not contain the six required criteria by CLIA. -- 2 of 2 --