Oceans Dermatology Llc

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 --