Suncoast Skin Solutions Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Suncoast Skin Solutions, Inc. on 03/24/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6168 493.1487 Condition: 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 record review and interview, the laboratory employed one (I) of five Testing Person(s) (F - J) performing grossing (macroscopic tissue examination) who did not meet the High Complexity Testing Personnel qualifications for the subspecialty of Histopathology. 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 record review and interview, one (I) of five (F - J) Testing Personnel (TP) who performed grossing (macroscopic examination of tissue) failed to meet the educational requirements for the subspecialty of Histopathology. Findings included: 1. The CMS-209 Laboratory Personnel Report form, signed and dated by the Laboratory Director on 03/24/2026, was reviewed. TP F - J were listed as performing high complexity testing. 2. "Competency Assessment For Grossing Personal" forms were reviewed. TP I's date of hire was documented as 04/17/2023. 3. TP I's highest level of education was a Bachelor of Science degree in Health Sciences degree. Their transcript was reviewed. It failed to meet the minimum requirements as specified at (b) (3)(ii)(A)(2). 4. An interview was conducted with the Laboratory Director on 03/24 /2026 at 4:50 p.m. They were not aware TP I failed to meet the minimum requirements specified at (b)(3)(ii)(A)(2). -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Suncoast Skin Solutions Inc. clinical laboratory on 07/31/19 to 08/01/19. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5400 Analytic Systems 493.1250 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to establish performance specifications of the Ep-CAM(Ber-EP4) immunohistochemical (IHC) stain (a histologic stain used to aid in the diagnosis of basal cell carcinoma) which was performed on the Leica Bond - Max instrument. (See D5423). D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as 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 -- applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish performance specifications prior to reporting patient results for Ep-CAM (BereP4) immunohistochemical (IHC) stain, a non FDA approved test, which was performed on the Leica-Bond Max automatic stainer from 12/19/18 to 07/31/19. The findings included: A review of the CMS-116 Application for Certification revealed a specialty of Histopathology with the following non-waived testing performed: hematoxylin and eosin (H&E), periodic acid Schiff's reagent, CD3, CD4, CD5, CD7, CD8, CD10, CD20, CD30, CD34, CD68, CK5/6, cytokeratin AE1/AE3, chromogranin, desmin, EMA, Factor 13A, K167, Melan A, S-100, SMA, tyrosinase, Ep-CAM(Ber-EP4), Sox 10, and synaptophysin. Record review of the "Antibody Validation Sign off" form that was signed 09/11/18 by the Lab Manager/Pathologist and Application Specialist showed "Validation In Progress" for the Ep-CAM(Ber-EP4) IHC stain. A review of the Final Pathology Reports revealed that the laboratory had prepared 41 Ep-CAM (Ber-EP4) patient slides (2 slide interpretations were done at the laboratory and 39 were sent to another laboratory for slide interpretation) since 12/19/18. Interview on 07 /31/19 at 11:45 am with the Laboratory Manager revealed he was unsure why the laboratory had not established performance specifications for the Ep-CAM(Ber-EP4) IHC stain. On 08/01/19 at 12:00 pm. the Laboratory Director stated he was unaware that the Ep-CAM(Ber-EP4) performance specifications had not been established. Review of the Laboratory Policy and Procedure, effective 05/01/16, titled Instrument /Method/Product Validation Procedure revealed "It is the policy of Suncoast Skin Solution to validate new instruments/methods/products prior to reporting patient results. The validation method includes evaluation of accuracy and precision. Validation records are kept for as long as the instrumentation/method/product is in use, plus an additional 2 years..." The procedure documented that this policy applied to new staining (H&E, special stains, and immunohistochemistry) procedures. -- 2 of 2 --