Skin Care Physicians Lld D/B/A

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at SKIN CARE PHYSICIANS LLD D/B/A BOCA RATON INSTITUTE on September 23, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, review of Safety Data Sheet (SDS) and staff interview, the laboratory failed to ensure protection from chemicals hazards used for Histopathology testing of Hematoxylin and Eosin (H&E) stain from 08/23/2024 to 09/23/2026. Findings included: 1-During a tour of the laboratory on 09/23/2026 at 10:20 AM, there was no fume hood to provide protection from respiratory chemical hazards of the reagents used for H&E stain (Gill 3 Hematoxylin, Eosin Working Solution, Pro- Par Clearant, Reagent Alcohol 100%). 2-The SDS sheets for Avantik: Gill 3 Hematoxylin, Eosin Working Solution, Pro-Par Clearant, Reagent Alcohol 100%, all included hazard statements regarding inhalation precautions. 3-During an interview on 09/23/2026 at 12:55 PM, Office Manager confirmed that there was no hood or any other method to ensure respiratory protection from chemical hazards used for H&E staining. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for 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 -- proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document the correct temperature for the cryostat for 26 out 52 testing dates in 2025. Based on record review and staff interview, the laboratory failed to document: Microscope verification Maintenance, Cryostat Temperature, Room Temperature, Room Humidity and Eye Wash in one out of four testing dates in July 2026. Findings included: 1- Review of "MOHS DAILY QUALITY CONTROL WORKSHEET" records for year 2025 revealed that stated the following "acceptable range -20 to -30 Degrees C." 2- Review of "CRYOSTAT TEMPERATURE LOG" for 12 consecutive months from January to December 2025, revealed that the recorded temperatures were missing the minus (-) sign for the following dates: 04/01/2025, 04/08/2025, 04/15/2025, 04/22 /2025, 04/29/2025, 05/06/2025, 05/08/2025, 05/13/2025, 05/20/2025, 05/27/2025, 06 /12/2025, 06/17/2025, 06/19/2025, 06/24/2025, 07/15/2025, 07/22/2025, 07/24/2025, 07/29/2025, 07/31/2025, 08/05/2025,08/07/2025, 08/19/2025, 08/26/2025, 09/02 /2025, 09/09/2025, 09/16/2025, 09/23/2025, 09/30/2025, 10/07/2025, 10/14/2025, 10 /21/2025 and 10/20/2025. 3-Review of MOHS DAILY QUALITY CONTROL WORKSHEET for July 2026, revealed that the laboratory failed to document the following on 07/28/2026: Microscope verification Maintenance, Cryostat Temperature, Room Temperature, Room Humidity and Eye Wash. That day the laboratory tested 10 patients. During an interview on 09/23/2026 at 12:19 PM, Office Manager confirmed that the Cryostat Temperature Logs missed the minus sign for temperature recordings for the days listed above in number 2 and that the laboratory failed to document Microscope verification Maintenance, Cryostat Temperature, Room Temperature, Room Humidity and Eye Wash on 07/28/2026. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document the acceptability of Hematoxylin and Eosin (H&E) quality control (QC) slide for one out of four testing dates in July 2026. Findings included: 1-Review of the procedure manual signed by the Laboratory Director on 03/02/2026 under policy titled "QUALITY CONTROL MEASURE FOR MODIFIED HEMATOXYLIN & EOSIN ROUTINE STAIN", stated "A quality control slide will be stained prior to staining actual case slides. This will determine the quality of the modified routine Hematoxylin and Eosin stain procedure. A quality control slide will be performed -- 2 of 3 -- every day that the stain is placed into use. The Mohs surgeon will review the slide in order to evaluate the stain quality." 2- Review of "MOHS DAILY QUALITY CONTROL WORKSHEET" for July 2026, revealed that the laboratory failed to record the number of QC slide stained on 07/28/2026 and failed to have the acceptance of the Mohs surgeon. 3-The laboratory tested 10 patients on that day. 4- During an interview on 09/23/2026 at 12:45 PM, the Office Manager confirmed that the laboratory failed to document the QC slide of 07/28/2026 and failed to document the acceptability by the Mohs surgeon. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey conducted on 8-06-20, found that Skin Care Physicians LLC D/B/A clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff Interview, the laboratory failed to perform peer- review proficiency testing twice a year for Scabies a subspecialty of parasitology from 2018 to 2019. Findings Include: A review of KOH Log sheet revealed the laboratory was performing scabies testing on 4 out 4 patients from 8/21/18 to 11/19/19. A review of the proficiency testing log showed no documentation of scabies peer review testing twice a year for 2018 and 2019. During an interview on 8-6-2020 at 11:54 am, the office manager confirmed that scabies peer review proficiency was not perform twice annually for 2018 and 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 record review and Staff interview, the laboratory failed to have a quality assurance policy and review for Scabies a subspecialty of parasitology . Findings Include: A review of KOH Log sheet revealed the laboratory was performing scabies testing on 4 out 4 patients from 8/21/18 to 11/19/19. A review of Quality Assurance Policy revealed no documentation of a written policy or review for scabies testing. During an interview on 8-6-2020 at 11:54 am, the office manager confirmed there was no quality assurance policy for Scabies and was not listed as a test preformed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)