Summary:
Summary Statement of Deficiencies D0000 The Westgate Skin & Cancer, PLLC laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements for laboratories as a result of an initial survey on 09/09/2025. The condition not met was: D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of educational credentials and interview, the laboratory failed to employ testing personnel that met the educational requirements for two of four testing personnel performing high complexity testing in Mohs testing. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) 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 -- (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of job descriptions, educational credentials and interview, the laboratory failed to employ testing personnel that meet the educational requirements for two of four testing personnel performing high complexity testing in Mohs testing. Findings follow. A. Review of the job description for Mohs Technician stated under Qualifications, "Have earned a high school diploma or equivalent and have documentation of training appropriate for the testing performed prior to analyzing patient specimens." And continued with requirements for training. This did not meet the educational requirements for high complexity Testing Personnel (TP). NOTE: Grossing, dissecting, and inking were not listed under the responsibilities of the position. B. Review of education credentials for TP # one and three, on the CMS form 209, showed the following: 1. Review of the transcript for TP #1 with a Bachelor of Science in Nursing showed she was lacking 2 hours in Chemistry. 2. TP #3 was lacking a diploma and/or transcript. A diploma was requested on 09/09/2025 at 1025 hours but not provided. C. Interview with TP #2 on September 09, 2025 at 0940 hours acknowledged TP # 1-3 performed grossing, inking, and dissecting in Mohs testing. Interview with the Practice Manager/TP #1 on September 09, 2025 at 1115 hours confirmed the findings. -- 2 of 2 --