Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Southern Internal Medicine on July 25, 2019. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Specific deficiencies cited are as follows: 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 record review and interview, the laboratory failed to perform yearly preventive maintenance on the Olympus CH2 microscope for 2 years ( 2017-2019) reviewed. Findings included: Review of the equipment maintenance records for 2 years from 2017 through 2019 showed no documentation performed for annual preventive maintenance on the Olympus CH2 microscope. Interview on 7/25/19 at 10: 30 AM , testing person # 2 confirmed that the laboratory did not have records to show annual preventive maintenance of the microscope. 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 --