Coastal Spine And Pain Institute Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 07/31/2025. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D6076 - 42 C. F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the laboratory's submitted form CMS-209, the laboratory's personnel records, and staff interview, the laboratory director failed to ensure testing personnel had documentation of education sufficient to qualify them to perform high complexity testing on patient specimens. Refer to D6102. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a review of the laboratory's submitted form CMS-209, the laboratory's personnel records, and staff interview, the laboratory director failed to ensure one of four testing personnel had documentation of education to qualify them to perform high complexity testing on patient specimens in 2024 and 2025. Refer to D6171. 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 laboratory's submitted form CMS-209, personnel records, and staff interview, the laboratory failed to ensure one of four testing personnel met the requirements to perform high complexity testing in 2024 and 2025. 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 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 -- 2 of 3 -- 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 laboratory's submitted form CMS-209, laboratory's personnel records, and staff interview, the laboratory failed to ensure one of four testing personnel met the requirements to perform high complexity testing in 2024 and 2025. Findings included: 1. Review of the laboratory's submitted form CMS-209 revealed four listed testing personnel performing high complexity testing. 2. Review of the laboratory's personnel records revealed testing person number four (TP4) was hired in February 2024 through August 2024 and again in June 2025. 3. Further review of the laboratory's personnel records revealed TP4 had documentation of Master of Science degree. There was no other diploma or transcripts specifying field of study or course hours to verify TP4's qualifications for high complexity testing. 4. In an interview on 07/31/2025 at 0945 hours in the office, the laboratory's Technical Supervisor (as indicated on submitted form CMS-209) confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 12/13/2023. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories. STANDARD LEVEL DEFICIENCIES were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to document laboratory director's and testing personnel's attestation to the routine integration of the samples into the patient workload for two of two PT events reviewed. Findings included: 1. Review of laboratory's PT records for 2023 revealed the laboratory used CAP (College of American Pathologists) as laboratory's PT provider, and performed testing of samples for Urine Toxicology 2023 Event B and Urine Toxicology 2023 Event C. 2. Further review of the above PT records revealed the laboratory did not document attestation to the routine integration of the samples into the patient workload for either of the two events. 3. In an interview on 12/13/2023 at 1035 hours in the laboratory, the facility's Technical Supervisor (as indicated on submitted Form CMS 209), after review of the data, confirmed the findings. Key: CMS = Centers for Medicare and Medicaid D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. 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 -- The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to retain required PT documentation for two of two PT events reviewed. Findings included: 1. Review of laboratory's PT records for 2023 revealed the laboratory used CAP (College of American Pathologists) as laboratory's PT provider, and performed testing of samples for Urine Toxicology 2023 Event B and Urine Toxicology 2023 Event C. 2. Further review of the above PT records revealed the laboratory only had retained CAP PT Participant Evaluation Summaries for the above events, and did not retain original mailing packets/instructions, testing records /results, attestation documents or Participant Evaluation packets. 3. In an interview on 12/13/2023 at 1035 hours in the laboratory, the facility's Technical Supervisor (as indicated on submitted Form CMS 209), after review of the data, confirmed the findings. Key: CMS = Centers for Medicare and Medicaid D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures for test establishment studies, test establishment records and staff interview, the laboratory failed to follow its own policy for establishment of interference for 33 of 33 analytes tested by the laboratory. Findings included: Review of laboratory's "Analytic Method Validation" policy for test establishment (approved by laboratory director on 07/14/2023) revealed: "Selectivity - Interferences ... Also, 6 separate lot numbers of blank urine will be tested to see if there are any endogenous interferences." 2. Review of test establishment study records for Interference revealed the laboratory performed only 1 blank urine sample per analyte. No blank urine lot number was documented. 3. In an interview on 12/13/2023 at 1220 hours in the laboratory, the facility's Technical Supervisor (as indicated on submitted Form CMS 209), after review of the data, confirmed the findings. Key: CMS = Centers for Medicare and Medicaid -- 2 of 2 --