Blue Ocean Dermatology Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Blue Ocean Dermatology LLC on February 3, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (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 interview, the laboratory failed to define cryostat temperature ranges for tissues processing in MOHS dermatology testing. Findings: Review of 2023 Cryostat maintenance log revealed there were no temperature ranges for the Cryostat to determine if the temperatures noted were appropriate for use. Review of Cryostat or microtome function test signed by the Laboratory Director on 5 /01/2020 read," to ensure all equipment needed for the performance of Mohs and frozen tissue cutting is clean and in working order perform patient tissue arrives Procedure: one hour before each 'Mohs or frozen procedure the histologist will conduct an inspection of the microtome to assure: 1. The cryostat is at the desired temperature and record temperature in the cryostat maintenance log ." On/2/3/2025 at 1:09 PM, the Office manager confirmed temperature ranges were not written in cryostat logs to determine when cryostat was at desirable temperature for use. 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 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 7, 2022. Blue Ocean Dermatology LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, review of the reagent log, and interview, the laboratory failed to ensure the reagents used in their Hematoxylin and Eosin Staining (H&E) were not expired prior to patient testing from 09/30/2021 to 09/07/2022. Findings: Observations made during a tour of the laboratory on 09/07/2022 at 10:00 AM, revealed opened bottles of 100% Reagent Alcohol, Scott's Tap Water Substitute, Hematoxylin, and Eosin that were expired. The 100% Reagent Alcohol (lot number 1933106) expired on 6/25/2022 and was opened on 07/16/2020. There were no other lot numbers of the 100% Reagent Alcohol in the laboratory. The Scott's Tap Water Substitute (lot number 2106413) expired on 03/10/2022 and had no open date recorded on the bottle or on the reagent log. There were no other lot numbers of the Scott's Tap Water Substitute in the laboratory. On 09/07/2022 at 10:02 AM, the Chief Financial Officer stated she could only assume the reagents were used and acknowledged no other lot numbers of the 100% Reagent Alcohol and Scott's Tap Water Substitute were in the laboratory. The Hematoxylin (lot number 94043) expired on 09/2021 and was opened on 10/08/2020. The laboratory also had two other bottles of Hematoxylin that were used and were not expired. Hematoxylin Solution Gills No. 3 (lot number SLCH6472) expired on 03/01/2023 was opened on 03/10/2022 and Hematoxylin Gill III (lot number 2034516) expired on 12/17/2022 and had no open 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 -- date recorded on the bottle or on the reagent log. The Eosin (lot number 111246) expired on 06/30/2022 and was opened according to the reagent log on 01/25/2020. The laboratory also had one other bottle of Eosin that was used and was not expired. Eosin (lot number 121683) expired on 11/30/2022 had no open date recorded on the bottle or on the reagent log. On 09/07/2022 at 10:02, the Chief Financial Officer stated she could only assume the reagents were used. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 15, 2020. Blue Ocean Dermatology clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory procedure manual failed to establish a comprehensive procedure to access the competency of 2 (B, C) out of 3 (A, B,C) testing personnel. Findings: Review of the procedure manual that was signed and dated by the Laboratory Director on 5/1/20 showed that the procedure titled "Quality Assurance Manual" section titled "Personnel Assessment" did not indicate how often competency assessments would be performed, and how competency assessment for testing personnel B and C were to be documented. No other procedure on competency assessment was available. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 7/14/20, the laboratory had an estimated annual test volume of 240 test per year. During an interview on 7/15/20 at 10:24 AM, the Chief Financial Officer acknowledged that the procedure did not include how often competency assessment were to be performed or how competency assessment were documented. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- 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)