Heights Dermatology-Beaumont

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on April 18, 2025. 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: Based on review of laboratory policy, laboratory quality control (QC) documentation, patient test records, and confirmed in interview, the laboratory failed to ensure the Hematoxylin and Eosin (H&E) staining materials used in histopathology was acceptable for 45 of 45 patients on days where the QC slide was determined to be unacceptable, for records reviewed from January 2024 through January 2025. The findings included: 1. Review of the laboratory policy titled "Mohs Surgery Procedure Manual" , section "Quality Control" included the following statement: "A control slide will be made and evaluated each day that a frozen section is prepared, and a record of that control slide will be maintained." 2. Review of the laboratory prepared form titled the "Control Slides" included the following information for slide assessment: "A = Acceptable N= Not Acceptable Month_____ Date Quality (A/N)

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, Material Safety Data Sheets (MSDS) and interview of facility personnel found that the laboratory failed to ensure that the laboratory had appropriate ventilation and storage for the six reagents and two stains used in the processing of patient tissue specimens for histopathology. The findings included: 1. Observations made during the tour the facility found that the laboratory had no ventilation system or chemical fume hood to provide adequate protection to testing personnel when using stains and reagents that produce harmful vapors. There was no flammable safety cabinet available to store flammable reagents . Reagents and stains stored in the cabinet were as follows: DMS Solutions Acetone lot 1271 Expiration 2023-09-28 Volu-Sol reagent Alcohol 95% lot VDN102 Expiration 2027-12-31 Platinumline 100% Reagent Alcohol lot 2236122 Expiration 2025-07-05 Volu-Sol Gill's Hematoxylin lot VCH196 Expiration 2024-04-30 EKI Acetic Acid, Glacial Lot 228506 Surgipath Hematoxylin Gill lot 080922 Expiration 2024-02-09 Platinumline Eosin Y Stain Solution lot 2310815 Expiration 2025-04-24 Volu-Sol Xylene lot 220207 Expiration 2027-05-31 Platinumline Xylenes lot 2300901 Expiration 2025-07-12 Platinumline Xylenes lot 2126009 Expiration 2024-03-23 EKI Ammonium Hydroxide lot 2223823 4 1 gallon containers of Platinumline 100% Reagent Alcohol lot 2236122 Expiration 2025-07-05 were also stored on the floor under the cabinet. 2. Review of policies and procedures found on page 4 under the heading STORAGE, USE AND HANDLING: "Reagents are stored according to manufacturer's instructions." 3. Review of MSDS sheets provided found under the heading Handling and Storage: Acetone - "Protect against physical damage. Store in a cool, dry, well -ventilated location, away from any area where the fire hazard may be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- acute. Outside or detached storage is preferred. Separate from incompatibles. Containers should be bonded and grounded to avoid static sparks. Storage and use areas should be No Smoking areas. Use non-sparking type tools and equipment, including explosion proof ventilation." Reagent Alcohol - " Wear personal protective equipment/face protection. Ensure adequate ventilation. Do not get in eyes, on skin, or on clothing. Avoid ingestion and inhalation. Keep away from open flames, hot surfaces or sources of ignition. Use only non-sparking tools. Keep in a dry, cool and well ventilated place. Keep container tightly closed. Keep away from Heat, sparks and flame. Flammables Area. Incompatible Materials, Acids, Ammonias, Peroxides, Acid Anhydrides, Acid Chlorides, Metals and Reducing Agents" Hematoxyline Gill III - "Ensure good ventilation of the work station. Wear personal protective equipment. Avoid contact with skin and eyes. Wash contaminated clothing before reuse. Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Store in a well ventilated place. Keep cool. Keep container tightly closed." Eosin Y Stain - "Wash thoroughly after handling. Use with adequate ventilation. Minimize dust generation and accumulation. Avoid contact with skin and eyes. Avoid ingestion and inhalation. Store in a cool, dry place. Keep container closed when not in use." Xylenes - "Keep container closed. Handle and open containers with care. D on handle or store near an open flame, heat, or other sources of ignition. Do not pressurize, cut, heat, or weld containers. Empty product containers may contain product residue. Do not reuse empty containers without commercial cleaning or reconditioning. Store in a cool, well- ventilated place away from incompatible materials. Fireproof , Separated from strong oxidants and strong acids. Protect material from direct sunlight. Laboratory samples should be handled in a fume hood. {Provide mechanical ventilation of confined spaces. Use explosion proof ventilation equipment." Ammonium Hydroxide - "Use only under a chemical fume hood. Wear personal protective equipment as required. Do not get in eyes, on skin, or on clothing. Do not ingest. If swallowed, seek immediate medical assistance. Do not breathe mist /vapors/spray. Keep containers tightly closed in a dry, cool and well- ventilated place. Corrosives are, Incompatible materials, Strong oxidizing agents, Metals, Acids, Fluorine, Halogens." Acetic Acid - "Protect against physical damage. Store in a cool, dry, well -ventilated location, away from any area where the fire hazard may be acute. Outside or detached storage is preferred. Separate from incompatibles. Containers should be bonded and grounded to avoid static sparks. Storage and use areas should be No Smoking areas. Use non-sparking type tools and equipment, including explosion proof ventilation." 4. During interview of the histotechnician conducted June 2, 2023 confirmed that the laboratory did not have a ventilation system or chemical fume hood for use by testing personnel when handling stains and reagents that produce harmful vapors, and no flammable safety cabinet for the storage of flammable reagents. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, Material Safety Data Sheets (MSDS) and interview of facility personnel found that the laboratory failed to ensure that the laboratory had appropriate ventilation and storage for the six reagents -- 2 of 3 -- and two stains used in the processing of patient tissue specimens for histopathology. (See D 3001) -- 3 of 3 --