Intermountain Bountiful Dermatology

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records, procedures and interview with Quality Assurance (QA) Manager (not listed on the CMS-209 Testing Personnel form), the laboratory failed to follow its procedures to perform preventative maintenance for one of two microscopes for the year 2021. Findings include: 1. Observed during laboratory tour at 10:20 a.m. on March 22, 2023 two microscopes available for use. 2. A review of the microscope maintenance records revealed the lack of maintenance documentation for one of two microscopes for the year 2021. 3. A review of ' Microscope Maintenance ' procedure manual revealed the laboratory staff failed to follow their procedure as stated, "Manufacturer's prescribed preventative maintenance should be performed at least annually." 4. Interview with QA Manager at 10:30 a.m. on March 22, 2023 confirmed the laboratory failed to follow their procedures to perform preventive maintenance on one of two microscopes for the year 2021. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by staff, the laboratory lacked an approved procedure manual for collecting, testing and reporting histopathology skin tissue specimens that included the signature and date of approval by the director. Findings include: 1. The laboratory procedure table of contents representing the online procedures failed to include the director's signature and date of approval. 2. In an interview on 04/13/2018 at approximately 12:05 P.M. the laboratory technical consultant confirmed the laboratory failed to have an approved procedure manual for histopathology tests performed. 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 --