Mowery Clinic Llc

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 review of the manufacturer's package insert instructions, freezer temperature logs for the time period of 7/1/2021 - 11/11/2021, and interview with the Technical Consultant #1 (TC#1) and General Supervisor #1 (GS#1) on 11/12/2021 at 0840, the laboratory failed to store quality control (QC) materials under conditions consistent with the manufacturer's instructions on two of two freezers for 202 days out of 240 days. The laboratory failed to document

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the Technical Supervisor (TS), the laboratory failed to define, perform and document a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. Findings Include: 1. Review of the laboratory's policies and procedures failed to a function check policy for the laboratory's thermometers and timers. 2. The TS stated the laboratory had not performed function checks or calibrations on any of the laboratory's thermometers or timers. The TS also confirmed the laboratory did not have a function policy or procedure for the timers or thermometers. The interview occurred 08/27/2018 at 3:16 PM. 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 --