Avera Medical Group O'Neill

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's procedure manual, review of the list of tests performed provided by the laboratory, and interview with the lab director the laboratory failed to have a procedure for the wet prep test performed. 1. Surveyor review of the laboratory's procedure manual revealed the procedure manual was missing the procedure for the wet prep test. 2. The list of tests performed provided by the laboratory revealed the laboratory had performed twenty nine wet prep tests in the last year. 3. Interview with the lab director on 12/13/2022 at 2:00 PM confirmed the laboratory did not have a procedure for the wet prep test and the laboratory had performed twenty nine tests in the last year. 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 D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on lack of documentation the laboratory failed to have proof of education on testing personnel #3, as listed on the CMS-209, performing moderate complexity testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the lab director, the laboratory 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 -- failed to have proof of education on one out of seven testing personnel performing moderate complexity testing. Findings are: 1. No proof of education documentation for testing personnel #3, as listed on the CMS-209, was presented at time of survey. 2. Interview with the lab director, on 4/20/2021 at 9:50AM, confirmed no documentation was available. -- 2 of 2 --