Ogden Clinic - Bountiful

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 Histotechnician 1 (HT1), room temperature and humidity of the laboratory was not monitored and documented. The laboratory performs approximately 650 MOHS procedures annually using the Avantik QS12 Cryostat. Findings include: 1. Document review revealed there was no written policy that included the monitoring and documentation of laboratory temperature and humidity. 2. Document review of the Avantik QS12 Cryostat Instruction Manual revealed the cryostat requires an operating environment of 5C to 35C and relative humidity of up to 60%. 3. Direct observation of the laboratory's flammable storage cabinet on September 7, 2023 at 10:05 AM revealed 10% Neutral Buffered Formalin was to be stored between temperatures of 15C to 30C. 4. In an interview on September 7, 2023 at 9:50 AM, HT1 confirmed room temperature and humidity was not monitored and documented for MOHS equipment and chemicals. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on Standard Operating Procedure (SOP) review, documentation review, and interview with histotech, SOPs are not being followed as written. Findings include: 1. SOP for cryostat maintenance includes instructions to thaw and decontaminate the cryostat quarterly. Maintenance record review does not include quarterly thaw and decontamination. 2. Quality Assurance (QA) SOP states that a comparison review of 5 or more Mohs cases will be performed twice annually. QA log states 3-5 Mohs cases will be reviewed twice annually. QA log review includes review of 3-5 Mohs cases twice annually. 3. SOP for cryosectioning states cryostat temperature acceptable range is -20 to -25 C. SOP for equipment states cryostat temperature acceptable range is -20 to -30C. SOP for frozen biopsy states acceptable cryostat temperature range is -23 to -28C. Cryostat maintenance log states cryostat acceptable temperature is -24 to -30C. 4. In an inteview on 6/29/21 at approximately 12:30 pm, the histotech confirmed that actual practice does not match the written SOPs. 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. 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 direct observation and interview with histotech, reagents and supplies were used after their expiration date. Findings include: 1. Three bottles of acetone were found in a cabinet, two full and one currently in use. The expiration date on all three bottles was 3/31/21. 2. Formalin jars for use in sending tissue to a reference laboratory were found in the supply cabinet. The expiration date on the formalin jars was 9/20. 3. Permanent Red stain was found in the refrigerator with an expiration date of 5/31/21. 4. Hi-Def reagent was found in the refrigerator with an expiration date of 12/31/20. 5. In an interview on 6/29/21 at approximately 12:45 pm, the histotech confirmed that expired reagents were in use. -- 2 of 2 --

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 Mohs maps review, lack of documentation, and interview with staff, the laboratory failed to include the lot numbers and expiration dates for 2 of 2 immunohistochemical test kit staining systems in use from 10/09/2016 to 10/09/2018 in the laboratory test records to ensure test kits were not used past their expiration dates. The laboratory tests approximately 15 cases per year for the persistence or absence of pathogenic melanocytes. Findings include: 1. Mohs surgery maps review for 2 cases selected, MH17-894 stained on 07/10/2017 and MH18-145 stained on 01 /31/2018, included documentation the laboratory performed Mart 1 and SOX 10 immunohistochemical stains to aid in determination of the presence of melanocytes in the layered specimens collected. 2. The laboratory lacked documentation the lot number of stains used on the test dates were not in use past the kit expiration date. 3. In an interview with staff on 10/09/2018 at approximately 11:30 A.M. staff confirmed they did not have a record for each lot number and expiration date for Mart 1 and SOX 10 stain kits. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document 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 -- all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on histopathology fixed tissue biopsy reports review, lack of documentation, and interview with staff, the tissue pathology reports for 4 of 4 reports reviewed failed to include the signature or electronic signature of the individual qualified to report histopathology tissue biopsy specimens. The laboratory performs approximately 125 fixed tissue biopsy diagnoses per year. Findings include: 1. Histopathology formalin fixed tissue reports reviewed for biopsy specimens T16-01184, T16-001258, T17- 000204, and T18-000411 lacked the signature or electronic signature of the dermatologist qualified to make the histopathology diagnoses. 2. In an interview conducted on 10/09/2018 at approximately 11:45 A.M. staff stated the reports were dictated by the physician without an electronic or hand written signature. -- 2 of 2 --