New York Cosmetic Skin & Laser Surgery Center

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 review of the laboratory procedure manual and interview with the billing manager, the laboratory failed to document room and cryostat temperatures as well as humidity on all days of slide processing and examination. Findings: 1. The cryostat manufacturer's requirements specified a temperature range of -20C - -30C. 2. The laboratory maintained a log for documenting room temperature and humidity. 3. No cryostat, room temperatures, and humidity were recorded for: a. October 19, 2023. b. September 21, 2023. c. June 29, 2023. d. On each day, five patient cases were evaluated. 4. Confirmed findings by interview with the billing manager on October 31, 2023, at 11:30 A.M. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedures, the quality control (QC) log, and interview with the billing manager, the laboratory failed to document H&E stain reactivity for each day of use. Findings: 1. The procedure manual indicated that on each day that patient slides were evaluated, the first slide assessed would be a QC slide for H&E stain reactivity. 2. The laboratory maintained a log documenting H&E stain reactivity. 3. QC slides were present in the processing area. 4. No H&E stain reactivity was recorded on: a. September 21, 2023. b. June 29, 2023. c. December 15, 2022. d. A total of seventeen patient cases were evaluated on the three respective days. 5. Confirmed findings by interview with the billing manager on October 31, 2023, at 11:30 A.M. -- 2 of 2 --

Summary Statement of Deficiencies 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 a surveyor's review of the laboratory policies/procedures, annual competency records and an interview with the Moh's technician, the laboratory failed to have a complete policy and procedure for personnel competency. Finding Include: It was confirmed by the Moh's technician on June 7, 2018, at approximately 1:00 pm that the laboratory failed to have a complete written procedure for annual competency to include direct observation of routine patient test performance which is one of six required components to assess the testing personnel's competency annually. 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 a lack of humidity records an and interview with the Moh's technician, 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 2 -- laboratory failed to follow the manufacturer's instructions to monitor and document the room humidity where testing is performed. Findings Include: It was confirmed by the Moh's technician, on June 7, 2018, approximately 12:30 pm that the Moh's technician failed to follow the manufacturer's written criteria to monitor and document the humidity of the room where Moh's testing is performed from June 16, 2016 through the date of this survey. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and an interview with the Moh's technician, the laboratory director failed to ensure that the annual competency review included direct observation and the laboratory followed the manufacturer's instruction to monitor and document the humidity of the room where testing is performed. Refer to D5209 and D5413 -- 2 of 2 --