Intermountain Utah Valley Clinic Dermatology

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 direct observation and interview with Technical Consultant (TC), the laboratory failed to ensure that the Black Tissue Marking Dye was not used past the expiration date. The laboratory performs approximately 850 histopathology tests annually. Findings Include: 1. Direct observation of tissue marking dyes revealed the Black Tissue Marking Dye, lot number 048108, had an expiration date of 07/2018 at 12:10 PM on 1/18/2024. 2. Interview with the TC at 12:10 PM on 1/18/2024 confirmed the Black Tissue Marking Dye was used for patient testing past the expiration date. 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 D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation, and confirmation by staff, the laboratory failed to retain histopathology slides for at least 10 years for 1 of 10 Mohs frozen micrographic surgery cases reviewed. The laboratory performed approximately 2500 Mohs surgical blocks (stages) per year. Findings include: 1. Patient test record for Mohs case number LM-17-11-1 included documentation the case consisted of 3 (III) stages. Stage II had 2 sections. 2. The laboratory failed to locate the slides for Stage II section B. 3. In an interview conducted on 01/09/2019 at approximately 10:45 A.M., the technical consultant and the director confirmed the laboratory failed to retain the slides from the B section of stage II. 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 --