Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Biomat USA Inc on 2/12 /2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The laboratory was found out of compliance with the following conditions: D6063 - 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 for 2 out of 33 testing personnel sampled for testing for total protein, (A and B). See D6078. 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 for 2 out of 33 testing personnel sampled for testing for total protein, (Testing Personnel A and B). Findings included: 1. Review of Laboratory Personnel Report CMS 209 (signed by the Laboratory Director 02/10/2025) revealed Testing Personnel A and B were listed as Testing Personnel. 2. Review of employment form revealed Testing Personnel A received their diploma at a foreign high school. There was no foreign equivalence documentation for comparing a foreign degree to United States education High school standard. 3. Review of employment form revealed Testing Personnel B received their diploma at a foreign high school. There was no foreign equivalence documentation for comparing a foreign degree to United States High school education standard. 4. Review of Initial Competency assessments revealed Testing Personnel A had an initial competency assessment done on 7/17 /2023 and Testing Personnel B had an initial competency assessment done on 11/25 /2024. Initial competency assessment involved observation of running a donor sample for total protein. 5. On 2/12/2025 at 6:43 PM, the Center manager confirmed Testing Personnel A and B were not qualified for moderate complexity testing due to lack of foreign equivalences. -- 2 of 2 --