Csl Plasma, Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/20/2025. The laboratory was found in compliance with standard-level deficiencies cited. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on a review of records and interview with the Assistant Manager of Quality and Center Manager, the laboratory failed to have a system that evaluated and defined the relationship between six of six Reichert TS handheld refractometers at least twice a year during the review period of March 2024 through the current date. Findings include: (1) On 11/20/2025 at 09:42 am, the Center Manager stated the laboratory performed serum total protein testing using 6 digital, handheld Reichert TS meters (refractometers); (2) A review of records for the testing from March 2024 through the current date identified no evidence the relationship between the six analyzers had been evaluated as follows: (a) Prior to 07/02/2024 (b) Between 07/02/2024 and 11/20/2025 (3) The records were reviewed with the Assistant Manager of Quality and Center Manager, who stated on 11/20/2025 at 12:20 pm, there was no documentation to prove the relationship between the analyzers had been evaluated at least twice a year in 2024. 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 D0000 The findings were reviewed with the assistant manager of quality, center manager, and associate director of operations and quality at the conclusion of the survey. 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 a review of records and interview with the manager and assistant manager of quality, the technical consultant failed to ensure that persons performing moderate complexity testing had been evaluated semiannually during the first year of testing. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed personnel records. The following was identified: (a) Testing Person #26 - The initial training was completed on 06/28/17. There was no evidence that a semiannual evaluation had been performed (due 12/2017). (2) The surveyors reviewed the records with the manager and assistant manger of quality, who stated there were no records to prove the above person had been evaluated semiannually. 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 --