Summary:
Summary Statement of Deficiencies D0000 An onsite complaint survey #2024014378 conducted, February 26, 2025 found the PRINCE LABORATORIES LLC laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition deficiency was cited: D6141 493.1459 - Condition: General Supervisor D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a qualified General Supervisor. Refer to D6143. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or (2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) 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 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; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing 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 -- personnel under 493.1489(b)(3); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3) Meet the requirements at 493.1443(b)(3) or 493.1449(c)(4) or (5); or (c)(4) Notwithstanding any other provision of this section, an individual is considered qualified as a general supervisor under this section if they were qualified and serving as a general supervisor in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or (f)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(f)(2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(f)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or (g). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a General Supervisor with a Supervisor Florida License since 11/04/2024. Findings included: 1. Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 02/26/2025 revealed that: a) The Laboratory Director (LD) is acting also as Clinical Consultant (CC) and Technical Supervisor (TS). b) The Laboratory had one General Supervisor (GS) and three Testing Personnel (TP), TP#1, TP#2 and TP#3. c) Review of personnel records for the person acting as GS revealed that the job description signed by her on 09/02/2024 the position was for "GENERAL SUPERVISOR Job Description". 2. Review of "Director Designee" form signed by the LD and GS on 11/04/2024 stated her title was Supervisor. 3. Review of her Florida License revealed that she had a Technologist License not a Supervisor License for Florida at the time of the inspection. 4. During an interview on 02/26/2025 at 4:19 PM with the owner and the the person acting as GS, they confirmed that the GS listed on the FORM CMS- 209 and in the Designee letter does not have a current Florida License as Supervisor. -- 2 of 2 --