Csl Plasma, Inc

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) record review and interview with TP13 and TP14 at 12:00 p.m. on 3/23/22, the laboratory tested proficiency samples for Total Protein on the refractometer twice before submitting the results to the proficiency provider. Patient samples are routinely tested once. Findings include: 1. Surveyor reviewed all PT records for Total Protein tested on the refractometer from 2020 and 2021 to include attestation records, raw data reports, submission sheets, evaluations, and

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records from last survey on 1/3/18 through day of survey on 1/28/20, the CMS 209 personnel form and interview with the laboratory technical consultant and other Quality Assurance (QA) staff at 2:30 pm on the day of survey, the technical consultant (TC) failed to evaluate and document the performance of testing personnel (TP) #5, #10, #11, and #16 responsible for performing moderate complexity (total protein) testing at least semiannually during the first year of employment. A semiannual evaluation must be performed during the first year of employment by the laboratory's technical consultant. Findings include: 1. Review of the personnel records for TP #5, #10, #11, and #16 revealed no 6 month evaluation/competency was documented as performed by the technical consultant during their first year of hire. 2. Interview with the laboratory TC and QA staff at 2:30 pm on the day of survey confirmed no 6 month evaluation/ competency was performed during their first year of employment on TP #5, #10, #11, and #16. Initial training was performed for TP #5 on 3/5/19, #10 on 5/6/19, #11 on 5/22/19, and #16 on 1/15/19. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first 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 2 -- This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records since the last survey on 1/3/18 and confirmation with the laboratory technical consultant and QA staff at 2:30 pm on 1/28 /20, the technical consultant failed to perform the evaluation/competency annually of testing personnel #1 and #6 as listed on the CMS-209 form in 2018. Findings include: 1. Review of the personnel records for TP # l revealed no annual evaluation /competency due in June 2019 was performed by the technical consultant. 2. Review of the personnel records for TP #6 revealed no annual evaluation/competency due in March 2018 was performed by the technical consultant. 3. Review of the personnel records and interview with the laboratory TC at 2:30 pm on the day of survey, confirmed that annual evaluations for both TP #1 and TP #6 were not performed annually by the technical consultant. TP # 1 evaluation was due in June 2019 and TP #6 evaluation was due in March 2018. -- 2 of 2 --