Csl Plasma, Inc - Temple 521

Summary Statement of Deficiencies D0000 The laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. 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 review of the laboratory's policy and procedure, training records, competency evaluations, and interview, the technical consultant failed to evaluate and document the performance of individuals responsible for performing moderate complexity testing at least semiannually during the first year the individual tests donor specimens for one of nine employees reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled CLIA Oversight, version 22.0, under Technical Consultant Task Performance Guide on page 26 stated, "Testing personnel have completed initial training with designated trainer or are due for 6 month or annual or other approval." The directive to perform two 6-month evaluations in the first year of testing is vague. B. Review of the laboratory's plateau data showed training was performed on 03/26/2024. Review of competency evaluations showed a competency evaluation was performed on 03/28/2024. A second 6-month competency was requested on July 29, 2025 at 1025 hours but not provided. C. Interview with the Assistant Center Manager on July 29, 2025 at 1025 hours confirmed there was only one 6-month competency performed. D6063 LABORATORY TESTING PERSONNEL 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 -- 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 review of pre-survey paperwork, educational credentials and interview, the laboratory failed to have documentation of education qualifying one out of 13 testing personnel to perform non-waived testing. See 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the job description, laboratory's policy and procedure, pre-survey paperwork, educational credentials and interview, the laboratory failed to ensure that one out of 13 testing personnel had documentation of qualifying education prior to performing patient testing reviewed for the moderately complex test total protein. Findings follow. A. Review of the Position Description under Job Specifications stated "Provide minimum hiring requirements, specialized knowledge, and other considerations required. Education: High school diploma or equivalent required." B. Review of the laboratory's policy and procedure titled Center Training Compliance Work Instruction, Version 2.0, on page 3 under New Hire Orientation stated, "Verify new hire's copy of High School diploma/GED". And on page 6 under New Hire Orientation stated, "If unable to provide Diploma/GED, Then Equivalent documentation of Diploma/GED confirming graduation such as transcripts or a certified letter." C. Review of the pre-survey paperwork titled Laboratory Personnel showed: 1. testing personnel #15 (as listed on the CMS Form 209) was hired 03/05 /2024. D. Review of the educational credentials showed: 1. testing personnel #15 had an Academic Excellence Certificate. There was no documentation of "diploma" or High School graduation. E. Interview with the Assistant Center Manager on July 29, 2025 at 1015 hours confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the Reichert Technologies Quick reference guide, validation procedures, laboratory's verification studies performed on its six Reichert refractometers, and staff interview, it was revealed the laboratory failed to have documentation of verifying the reportable range for total protein was comparable to the ranges establashed by the manufacturer for five of six refractometers. The findings included: 1. Review of the Reichert Technologies quick reference guide found on page 2 under the heading Results- " The meter's range is 0.0 to 15.1 g/100 mL plasma protein." 2. Review of laboratory procedure titled Validation for the Installation or Reinstallation of the Refractometer (effective 01-Jul-20 revealed the following steps in the validation process: " ...6. Receive BioRad Trilevel Minipak Liquid Unassayed MultiQual 1,2,3 ... 7. The level 3 BioRad MultiQual will be used to verify manufacturer's accuracy and establish precision .... 8. Prepare to Test: Select 3 different employees trained to operate the refractometer ... 9. Each employee will run 5 replicates of each level of control and record results on the attached Data Sheets ... 12. Enter the values for each employee on the spreadsheet. There should be fifteen (15) values for each control level. Excel will perform the calculation for Center Accuracy and Center Precision." 1. A review of the laboratory's verification studies performed on the Reichert refractometers in December 2021 revealed the facility 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 documentation of verifying the reportable range for total protein met the manufacturer's specifications of 0.0 to 15.1 g/dl for five of six refractometers in use. Serial Number 14496-1020 - verified values 6.1 g/dl to 10.3 g/dl on 12/17/2020 Serial Number 14500-1020 - verified values 6.1 g/dl to 10.4 g/dl on 12/17/2020 Serial Number 14499-1020 - verified values 6.0 g/dl to 10.4 g/dl on 12/17/2020 Serial Number 14497-1020 - verified values 6.0 g/dl to 10.3 g/dl on 12/17/2020 Serial Number 14494-1020 - verified values 6.1 g/dl to 10.5 g/dl on 12/17/2020 Serial Number 14501-1020 - verified values -0.1 g/dl to 10.3 g/dl on 11/3/2021 4. Review of the Reichert Protein Refractometer verification studies revealed the Level 1, 2 and 3 quality control values from each of the 5 replicates performed by the 3 different employees. A "center accuracy" was determined for each refractometer. "Center Accuracy" was defined as "equal to the calculated mean". 5. Interview with the Assistant Manager of Quality conducted February 16, 2022 at 10:43 AM in the conference room confirmed the laboratory did not verify the manufacturer's reference ranges below 6.0 g/dl or above 10.5 g/dl on the five refractometers verified in December 2020 prior to using them for specimen testing. -- 2 of 2 --