Csl Plasma, Inc

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 record review and interviews with the Assistant Center Manager (ACM), the Quality Specialist (QS) and the Assistant Manager of Quality (AMQ), the Technical Consultant (TC) failed to evaluate and document the competency of one out of 12 newly listed testing personnel (TP), at least semiannually during the first year they tested donor total protein specimens in the subspecialty of Routine Chemistry. This deficient practice had the potential to affect 2,210 out of 2,210 donor total protein tests performed by TP#3 between 07/24/23 through 07/10/2024. Findings Include: 1. Review of the laboratory's "CLIA Personnel Reference Guide" policy and procedure, provided on the date of the inspection found instructions under the TC's "Description of Responsibility" to assess the competency of new testing personnel initially, at six months and 12 months within the first year of testing patient specimens. 2. Review of the laboratory's Form CMS-209, approved by the Laboratory Director via signature and date on 03/13/2025, revealed 12 out of 20 individuals newly listed, since the last CLIA inspection on 05/10/2023, and qualified by the Laboratory Director to perform moderately complex total protein testing procedures. 3. Review of the laboratory's 2023 and 2024 training and competency assessment documentation provided found the following for TP#3: 07/24/2023 - initial demonstration Not Completed - first semi- annual competency 07/10/2024 - second semi-annual competency 4. The Inspector requested the first semi-annual competency assessment for TP#3 within the first year of testing donor specimens at this center from the ACM, QS and AMQ. The AMQ confirmed the TC did not conduct the six month (first semi-annual) competency assessment for TP#3 as required by the CLIA regulations and the center's policy and 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 -- procedure and was unable to provide the requested documentation on the date of the inspection. The interviews occurred on 03/13/2025 at 9:35 AM. -- 2 of 2 --

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 record review and interviews with the Center Manager (CM), Associate Director of Operations and Quality (ADOQ), Quality Specialist (QS) #1, QS#2 and testing personnel (TP) #4, the Technical Consultant (TC) failed to evaluate and document the competency of TP#10 and TP#13 who were responsible for moderate complexity total protein testing procedures at least semiannually during the first year the individuals tested patient specimens. All patients tested by TP#10 and TP#13 in 2018 and 2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's Form CMS-209, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 05/09/2019, revealed seven out of 17 individuals listed and credentialed as TP who had performed patient total protein testing procedures since the facility opened on 10/25/2017. 2. Review of the laboratory's "CLIA Oversight" policy and procedure, provided on the date of the inspection, approved, signed and dated by the Laboratory Director, revealed the following "Direct Observation and Assessment of Testing Personnel" competency assessment instruction: "Testing personnel have completed initial training with designated trainer or are due for 6 month or annual approval." 3. Review of two out of seven of the laboratory's 2018 and 2019 semiannual competency assessment records, provided on the date of the inspection, did not find any record that a 12 month (the second semiannual) competency assessment was conducted on TP#10 and TP#13 during their first year of testing patient specimens. 4. The Inspector requested the laboratory's 2018 and 2019 12 month (the second semiannual) competency assessment records for TP#10 and TP#13 from the CM, ADOQ, QS#1, QS#2 and 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 -- TP#4. The CM, ADOQ, QS#1, QS#2 and TP#4 confirmed that the laboratory did not follow their written policy and procedure, misunderstood the "semiannual" regulation interpretation, did not assess the second semiannual competency of new TP during the first year of testing patient specimens, as required, and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 05 /09/2019 at 4:15 PM. -- 2 of 2 --