Legacy Dermatology Group

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: . Based on observation and interviews, the laboratory failed to ensure its hematoxylin stain was not used past its expiration date for one of one bottle in the laboratory. Findings include: 1. The surveyor observed the laboratory's flammable cabinet on 3/9 /26 at 10:04 am. Inside, there was one bottle of hematoxylin stain with the expiration date of 1/11/26. 2. An interview on 3/9/26 at 10:45 am with the office manager confirmed the hematoxylin stain had exceeded its expiration. 3. A review of the laboratory's patient testing logs showed a total of 22 patients have received histopathology testing with hematoxylin and eosin stains since 1/11/26. 4. A phone interview on 3/9/26 at 11:04 am with the laboratory director confirmed the above findings. 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 D0000 A recertification survey was performed on January 13, 2026 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following condition-level deficiencies: 493.1219 Condition: Histopathology. 493. 1441 Condition: Laboratories performing high complexity testing; laboratory director. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observations, record review, and interviews, the laboratory failed to follow its quality assessment policy (refer to D5391), failed to include the laboratory's process for using the Histopro 414 linear stainer (refer to D5403), failed to use procedures approved, signed, and dated by the laboratory director prior to use (refer to D5407), failed to establish performance specifications for its Mohs surgery histopathology testing prior to patient testing (refer to D5423), failed to perform weekly maintenance for its Dakewe cryostat 6250 in accordance with manufacturer's instructions (refer D5429), failed to establish a maintenance protocol for the use of its Dakewe 6250 cryostat (refer to D5433), and to perform and document its hematoxylin and eosin staining characteristics (refer to D5473). D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: . Based on record review, observation, and interview with the Mohs technician, the laboratory failed to follow its quality assessment policy for one (Patient #2) of four patients reviewed. Findings include: 1. A review of the laboratory's "Quality Assurance Incident Management Plan" policy revealed a section titled "Incident Evaluation" stated, "All incidents foreseen and unforeseen are to be immediately reported to the laboratory director. Evaluations and when necessary outside consultations are to be conducted to determine the true cause (See Documentation of Problems/Discrepancies). Laboratory equipment or tissue processing errors are to be reported and recorded by the Mohs technician and reviewed with the laboratory director. Medical significance to staff or patients will be determined by the lab director, and when necessary, testing will be halted until