Highline Dermatology& Skin Cancer

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of procedures, patient records and slides, and interview with Testing Personnel (TP) # 3, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the preanalytic systems from January 1, 2021 to June 29, 2022. Findings: 1. Review of Specimen Handling, Storage, Preservation and Identification procedure revealed, "3.4.9 Slides are labeled with the Mohs number, patient name, date, stage (roman numeral), piece # (numbers) and slide # (numbers)." 2. Review of patient slides revealed inconsistent labeling:. M22-229, M21-178 labels lacked stage #, piece # and slide #; M22-117(II), M22-234 (II) labels lacked piece # and slide #; M22-126 (III)1, M22-126 (II)2, M22-126(II)1, M21-176(II)1-3, lack slide #; and M20-81(I)C, M20-81 (I)B lack piece #. 3. No documentation of

Summary Statement of Deficiencies 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 interview, the laboratory failed to record temperature and humidity at the frequency described in their Quality Assurance Program. Findings: 1. Review of Quality Assurance Program, General Laboratory Cleaning and Safety, Equipment Quality control for Cryostats procedure revealed "1) Room temperature and humidity is checked and recorded daily." 2. Review of Room Temperature & Humidity Log documents for August through December of 2020, revealed temperature and humidity values recorded only on days of Cryostat use. 3. Confirmed during interview with Laboratory Director (LD) on 12/10/2020 at 11:50 am, the Room Temperature & Humidity Logs lacked daily record of temperature and humidity as described in the Quality Assurance Program. 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 --