Summary:
Summary Statement of Deficiencies D0000 During a recertification survey performed on 08.11.2025, the laboratory was found out of compliance with the following condition: 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS 209), review of education documents, review of patient test reports, and staff interview, the testing person two (TP2) did not qualify as a high complexity testing person (Refer to 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) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at 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 -- 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 a review of the Form CMS 209, review of education documents, review of patient test reports, and staff interview, testing person two (TP2) did not meet the regulatory requirement for performing high-complexity testing. The findings include: 1. A review of Form CMS 209 revealed that TP2 was listed as a high complexity testing person. 2. A review of education documents and college transcript for TP2 revealed that TP2 did not qualify as a high complexity testing person due to a lack of required science hours. 3. A random review of the following patient test reports revealed Gross Descriptions performed by TP2: #S23-00900: Hepatic Flexure, Poly grossed on 06.22.2023 #S24-00340: Ascending Colon, grossed on 03.14.2024 #S24- 00373: Antrum, Duodenum Second Part, Esophagus Lower Third, grossed on 03.28.2024 #S25-00398: Rectum, grossed on 04.23.2025 #S25-00726: Antrum, Stomach Body, Polyp, grossed on 07.28.2025 4. An interview with TP2 on 08.11.2025 at 9:30 a.m. confirmed that TP2 performs gross examinations that include measuring and cutting specimens when needed and recording their descriptions. -- 2 of 2 --