Cedar Dermatology

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(ii) Perform and document the function checks, including background or 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 laboratory record review and interview with the laboratory manager, the laboratory failed to define and perform maintenance and function check protocols for 3 of 3 microscopes. The laboratory performed 3923 microscopic tests annually. Findings include: 1. Laboratory record review found that no maintenance was performed between 10/30/2023 and 1/17/2025 for 3 of 3 microscopes. 2. Record review failed to produce a maintenance protocol for laboratory microscopes. 3. Interview with the laboratory manager on 02/19/2025 at approximately 2:05 PM confirmed, that the laboratory failed to have a maintenance protocol and document maintenance activities for 3 of 3 microscopes. ___ D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: 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 -- Based on review of stain quality control documentation, and interview with staff, the laboratory failed to document Hematoxylin and Eosin (H&E) quality controls. The laboratory performed approximately 3798 histopathology tests annually. Findings include: 1. The laboratory quality control records failed to include histopathology H&E quality control for 2023, 2024, and 2025. 2. The laboratory manager confirmed during an interview on 02/19/2025 at approximately 2:54 PM, that the laboratory failed to review and record H&E quality controls for each day of testing. -- 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 document review, direct observation, and interview with the lab manager, room temperature and humidity of the laboratory was not monitored and documented since the last survey conducted on 10/30/2019. The laboratory performs approximately 2798 MOHS procedures annually using the Microtome Cryostat HM 505 E. Findings include: 1. Document review of the Microtome Cryostat HM 505 E Instruction Manual revealed the cryostat requires an operating environment of 5C to 40C and relative humidity of up to 60%. 2. Direct observation of the laboratory on 11 /02/2023 at 10:00 AM failed to locate a thermometer or hygrometer in the laboratory. 3. In an interview on 11/02/2023 at 10:05 PM, the lab manager confirmed room temperature and humidity was not monitored and documented for the Microtome Cryostat HM 505 E D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) 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 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation and interview with the lab manager, the laboratory failed to properly label eight of eight bottles of tissue marking dyes used in MOHS procedures since the last survey on 10/30/2019. The laboratory performs approximately 2798 MOHS procedures annually. Finding include: 1. Direct laboratory observation on 11/02/2023 at approximately 9:50 AM, found eight of eight bottles of tissue marking dyes were not labeled with their storage requirements, preparation dates, and expiration dates. 2. In an interview on 11/02/2023 at approximately 9:55 AM, the lab manager confirmed that the tissue marking dyes were not properly labeled. -- 2 of 2 --