Dermatology & Skin 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 surveyor review of the Avantik Bluing Reagent and Hematoxylin staining dyes (SD) and "Laboratory Temperature/Humidity Log" (LOG) and interview with the Office Manager (OM), the laboratory failed to provide an accurate room temperature acceptable range per the (SD) labels on the LOG from 11/15/22 to the date of the survey. The findings include: 1. The surveyor observed the strictest requirement for the room temperature, 68-86F, based on the SD labels, but the acceptable range was 64.4-95F on the LOG. 2. The OM confirmed on 3/7/24 at 1:30 pm that the acceptable range for room temperature on the LOG was not accurate. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or 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 -- baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the Ink Bird thermohygrometer used for room temperature and humidity and interview with the Office Manager (OM), the laboratory failed to provide documentation of calibration for the Ink Bird thermohygrometer used in the laboratory from 11/15/22 to the date of the survey. The findings include: 1. The laboratory could not provide documentation of calibration for the Ink Bird thermohygrometer used in the laboratory. 2. The OM confirmed on 3/7 /24 at 1:00 pm that they could not provide documention of calibration of the Ink Bird thermohygrometer. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor observation of Histology reagents and interview with the Office Personnel (OP), the laboratory failed to discard expired Histopathology reagent from 6 /30/22 to the date of survey. The finding include: 1. Gill 3 Hematoxylin reagent expired 6/30/22 2. Approximately 300 patients were tested with expired reagent. 3. The OP confirmed on 11/15/22 at 12:30 pm that the laboratory used expired reagents. 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 --