Oceans Dermatology Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Oceans Dermatology LLC on June 10, 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, interview, and review of the laboratory procedure manual, and safety data sheets (SDS), the laboratory failed to ensure protection from chemical hazards used in their Hematoxylin and Eosin (H&E) stain from 5/22/24 to 6/10/26. Findings Included: 1. During a tour of the laboratory on 6/10/26 at 12:13 PM, there was no fume hood over the automated stainer and there were no respirators observed. 2. Review of the procedure titled, Hematoxylin and Eosin Automatic Stainer (signed and dated by the Laboratory Director on 1/08/26) revealed, the laboratory used the following chemicals in their H&E stain: 100% Reagent Alcohol, Hematoxylin, Eosin, Formalin Substitute, and Tap Water. 3. Review of the Safety Data Sheet (SDS)'s for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific Hematoxylin Stain Solution, Gill III, and Mercedes Scientific Eosin Y Solution, 1% w/v (weight per volume) in Alcohol, noted, "if exposure limits are exceeded or irritation is experienced, NIOSH/MSHA Approved respiratory protection should be worn." 4. Review of the SDS's for the Mercedes Scientific 100% Reagent Alcohol and Mercedes Scientific Eosin Y Solution, 1% w/v (weight per volume) in Alcohol, noted, "Do not breathe dust/fume/gas/mist/vapors/spray," and "Wear protective gloves /protective clothing/eye protection/face protection." 5. Review of the SDS's for the 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 -- Mercedes Scientific Hematoxylin Stain Solution noted, "Ensure adequate ventilation, especially in confined areas." 6. Review of the SDS's for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific Hematoxylin Stain Solution, Gill III, and Mercedes Scientific Eosin Y Solution, 1% w/v (weight per volume) in Alcohol showed each had the symbol for respiratory tract irritant. 7. On 6/10/26 at 3:00 PM, the Consultant acknowledged there was no fume hood over the stainer and the laboratory was not performing any chemical monitoring. Word Key NIOSH - National Institute for Occupational Safety and Health MSHA - Mine Safety and Health Administration 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 interview, and record review, the laboratory failed to verify the accuracy of the Mart-1 (Melanocytic Marker) Immunohistochemical (IHC) stains at least twice annually for 2024 and 2025. Findings Included: 1. Review of the test menu attached to the Clinical Laboratory Improvement Amendments Application for Certification (signed by the Laboratory Director on 6/10/26) revealed, the laboratory read out the H&E stain and the MART-1 IHC stain. 2. Review of the Quality Assurance Proficiency Testing form revealed, peer review was performed on Testing Personnel A (Laboratory Director) and on Testing Personnel B on 6/06/24, 12/26/24, 6/05/25, and 12/08/25. 3. Review of the Quality Assurance Proficiency Testing form and review of the Melanoma Quality Control Slides log revealed only one peer review case was performed on Testing Personnel B on 6/05/25 that had a Mart-1 stained slide. 4. Review of the Quality Assurance Proficiency Testing form revealed, there was no documentation of the review of the Mart-1 stain listed on the form. 5. On 6/10 /26 at 1:20 PM, the Consultant acknowledged only one case from 2024 and 2025 had a Mart-1 stained slide. 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 interview, and record review, the laboratory failed to document the acceptability of the Mart-1 (Melanocytic Marker) Immunohistochemical (IHC) stain positive and negative quality control slide for 19 of 19 days (1/09/25, 1/16/25, 1/23 /25, 2/06/025, 2/13/25, 2/27/25, 3/06/25, 3/13/25, 3/20/25, 4/03/25, 5/15/25, 6/05/25, 6 /19/25, 7/10/25, 7/17/25, 7/23/25, 8/07/25, 8/14/25, 9/18/25); and failed to document the acceptability of the Mart-1 IHC stain negative quality control slide for 5 of 5 days, (10/23/25, 11/06/25, 11/20/25, 12/11/25, 12/18/25). Findings Included: 1. Review of the Melanoma Quality Control Slides log for 2025 noted, check if the positive and -- 2 of 3 -- negative control slides are ok. 2. Review of the Melanoma Quality Control Slides log for 2025 revealed the laboratory failed to document the acceptability of the Mart-1 (Melanocytic Marker) Immunohistochemical stain positive and negative quality control slide for the following dates: 1/09/25, 1/16/25, 1/23/25, 2/06/25, 2/13/25, 2/27 /25, 3/06/25, 3/13/25, 3/20/25, 4/03/25, 5/15/25, 6/05/25, 6/19/25, 7/10/25, 7/17/25, 7 /23/25, 8/07/25, 8/14/25, and 9/18/25. 3. Review of the Melanoma Quality Control Slides log for 2025 revealed, the laboratory failed to document the acceptability of the Mart-1 (Melanocytic Marker) Immunohistochemical stain negative quality control slide for the following dates: 10/23/25, 11/06/25, 11/20/25, 12/11/25, and 12/18/25. 4. On 6/10/26 at 2:36 PM, the Consultant acknowledged the stain quality was not documented. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 5/22/24 at Oceans Dermatology, a clinical laboratory in Boynton Beach, Florida. Oceans Dermatology was found not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for 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: (1) Water quality. (2) Temperature. (3) Humidity. (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 room temperature and humidity of the laboratory for 1 of 4 days reviewed in September 2023, and failed to ensure the cryostat temperature was documented for 1 of 4 days reviewed in September 2023. Findings include: Record review of the document titled "Mohs Accession Log" showed 6 cases of Mohs were tested on 9/14 /23 by Testing Person A and 2 cases were tested on 9/14/23 by Testing Person B. Review of the document titled "Mohs Laboratory Quality Control" showed no documentation of Laboratory Temperature, Laboratory Humidity, or Cryostat Temperature for 9/14/23. During the interview with Testing Person C on 5/22/24 at 12: 45pm, it was confirmed the documentation was missing for room temperature, humidity, and cryostat temperature on 9/14/23. 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 -- D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to maintain daily quality control (QC) slide documentation for Mohs testing for 1 out of 4 testing days reviewed in September 2023. Findings include: Record review of the document titled "Mohs Accession Log" showed 6 cases of Mohs were tested on 9/14/23 by Testing Person A and 2 cases were tested on 9/14/23 by Testing Person B. Review of the document titled "Quality Control Staining" showed QC documentation on 9/7/23, 9/21 /23, and 9/28/23. There was no QC documentation for 9/14/23. The facility policy for quality control states "A daily QC slide is done using the first case of the day; the doctor will look for the normal reaction of the stain on the tissue and indicate it on the Daily QC slide log." During the interview with Testing Person C on 5/22/24 at 12: 45pm, it was confirmed the QC documentation for 9/14/23 was missing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 3/11/22 at Oceans Dermatology LLC, a clinical laboratory in Boynton Beach, Florida. Oceans Dermatology LLC, is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the Laboratory Director failed to have a written competency procedure and failed to assess the competency of Testing Personnel #B for two out of two years ( 2020 - 2022). Findings Included:: Record review of the laboratory's policy and procedure manual revealed that the laboratory did not have a written competency procedure that described the process the Laboratory Director would use to assess the competency of Testing Personnel #B. Review of the personnel records for Testing Personnel #B revealed competency had not been assessed on Testing Personnel #B for two out of two years ( 2020 - 2022). On 03/11/2022 at 11:30 a.m., the Laboratory Director stated she did not know that the laboratory needed a competency procedure and that Testing Personnel #B needed competency assessment every year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --