Summary:
Summary Statement of Deficiencies D0000 On 10/26/2022, an announced CLIA recertification survey was conducted at CSL Plasma Inc. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6063 Laboratory Testing Personnel 493.1421 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 verify the foreign equivalency for diploma from Venezuela for 1 (#L) out of 29 Testing Persons reviewed (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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a 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 -- high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview the Laboratory failed to verify the foreign equivalency for diploma from Venezuela for 1 (#L) out of 29 Testing Persons reviewed. Findings Included: Review of Testing Person #L's education revealed a diploma from Venezuela. There was no foreign equivalency performed on the diploma. Testing Person #L's date of hire was 01/10/2022. Interview on 10/26/2022 at 12:00 PM ., with the Center Manager confirmed that Testing Person #L did not have a foreign equivalency for the diploma. -- 2 of 2 --