Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CSL Plasma Inc on January 14-15, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 493.1201 Condition: Laboratory Testing Personnel 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 record review and interview, the laboratory failed to have qualified Testing Personnel (TP) for 1 (TP#A) of 45 Testing Personnel in the subspecialty of Routine Chemistry (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 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 -- 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 record review and interview, the laboratory failed to have qualified Testing Personnel (TP) for 1 (TP#A) of 45 Testing Personnel in the subspecialty of Routine Chemistry. Findings included: 1. Review of employment form revealed Testing Personnel #A received their diploma at a foreign high school in Jamaica. There was no foreign equivalence documentation for comparing a foreign degree to United States education High school standard. 2. Review of 2024 Medical Laboratory Evaluation M-2 signed by the Laboratory Director on 05/28/2024 revealed Testing Personnel A performed total protein proficiency testing for the second event in 2024. 3. On 1/14/2026 at 5:48 PM, the Office Manager confirmed Testing Personnel #A was not qualified for moderate complexity testing due to lack of foreign equivalences. -- 2 of 2 --