Park Avenue Dermatology North

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Park Avenue Dermatology North was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 staff interview, the laboratory failed to perform competency evaluations on 2 of 2 Testing Personnel who perform potassium hydroxide (KOH) and Scabies testing in the subspecialties of Mycology and Parasitology for 2 of 2 (2023-2024) years reviewed. Findings include: The review of employee competency records showed that no competency evaluations were conducted for Testing Personnel #C and #D, who perform KOH (potassium hydroxide) and scabies testing, in 2023 and 2024. During the interview on 02/6/2025 at 10:08 AM with the Mohs technician, it was confirmed that the laboratory had not performed competency evaluations for Testing Person #C and #D. . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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. 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 observation and staff interview, the laboratory failed to ensure the PMS Fungal/Tzanck stain was not expired prior to patient testing. Findings include: Observations made during a tour of the laboratory on 2/6/25 at 9:58 AM, showed one bottle of "PMS Fungal/Tzanck" stain with lot number K21551 expired 5/31/2023, and a second bottle of "PMS Fungal/Tzanck" with lot number K229C4 expired 9/30/24. During an interview on 2/6/25 at 10:10 AM with the Mohs tech, it was confirmed the two bottle of stain were expired. -- 2 of 2 --

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 with the Manager, the laboratory failed to document room temperature and humidity for 2 out of 2 years ( 2017-2019 ) reviewed. Findings Included: Review of maintenance records from 03/08/17 through 03/08/19 found no room temperature and humidity documented. During an interview on 03/08/19 at 11:00 AM, the Manager confirmed that there were no room temperature and humidity recorded. 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 --