Schweiger Dermatology Pllc - New Hyde Park

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 lack of calibration records for both the room & humidity thermometers and an interview with the general supervisor, the laboratory failed to maintain the certification for the thermometers, as required by the manufacturer. FINDINGS: 1. The laboratory failed to maintain the required certification and calibration on room temperature and humidity thermometer in 2020, 2021, and up to survey date. 2. The general supervisor confirmed on 3/3/2022 at approximately 10:30am, the laboratory failed to maintain the certified calibrated thermometer. D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established 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 -- performance specifications are identified, This STANDARD is not met as evidenced by: Based on lack of certification and calibration of thermometer used for room temperature and humidity, it was determined that the laboratory director failed to implement and maintain the laboratory's quality assessment program. It was confirmed on an interview with general supervisor on 3/3/2022 about 10:30am. Refer 5413 -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an interview with the previous Director and a review of the Federal Aspen Database and Physician Office Laboratory Evaluation Program (POLEP) records, the laboratory failed to notify POLEP of a change of Directorship required with 30 days of the previous Director's resignation as Director. Findings: 1. Under CLIA Regulation 493.51 Laboratories issued a Certficate of Compliance must notify POLEP within 30 day of a change of Director or Technical Supervisor. 2. During a phone discussion with POLEP on Directorships on October 25 at approximately 1:00 PM, the former Director indicated that she had resigned as Director as of September 9, 2018. 3. As of November 30, 2018, we have not received any documentation from the laboratory indicating a change in Directorship. 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 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 surveyor's review of Cryostat temperature records and interview with the office manager, the laboratory failed to follow the Cryostat manufacturer's temperature requirement and failed to follow the laboratory's temperature policy for Cryostat from January 2018 through the survey date. FINDINGS: 1. The laboratory performs Mohs surgery approximately once per month. The manufacturer of the Cryostat used for Mohs slide processing and the laboratory's temperature policy require that the Cryostat temperature to be monitored and documented on each day of surgery. 2. On June 12, 2018 at approximately 10:30 AM the office manager confirmed surveyor findings that the laboratory failed to monitor and document the cryostat temperature for six days from January 2018 through the date of this survey. 3. Approximately 30 patient specimens were tested and reported for Mohs surgery when the cryostat temperature was not monitored. 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 --