Franklin Medical Consultants

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant (TC), the laboratory failed to perform and document thermometer calibrations and/or replace an expired thermometer for 1 (S/N 90817839) of 1 thermometer in use. Findings include: 1. During a tour of the laboratory on 4/05/2023 at 9:04 am, the surveyor observed a Fisher Scientific thermometer on top of the paper towel rack for the room temperature and humidity with an expiration date of 03/18/2011. 2. A record review of the "Thermometer Accuracy Verification Log" revealed a lack of documentation for the humidity. 3. When queried on 4/05/2023 at 11:15 am about the verification of the humidity readings, the TC was not able to provide the surveyor documentation to show the thermometer humidity had been calibrated. 4. An interview on 4/05/2023 at 11:15 am, the TC confirmed the laboratory failed to perform and document thermometer calibrations and/or replace the expired thermometer for the humidity readings. D5781

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure test results were sent to the final report destination for 1 (Patient #16) of 10 patient test reports reviewed. Findings include: 1. A review of the laboratory's patient test orders revealed Patient #16 had an order for a Thyroid Stimulation Hormone (TSH) test to be performed on 6/25/20. 2. A review of the laboratory's patient test reports revealed a lack of documentation of a test report for Patient #16 having a TSH test ordered. 3. A review of the laboratory's "Ordering, Verifying, and Reporting Lab Results" policy revealed a section titled "Reporting In-House Lab Results" stating, "All In-House lab results are to be given directly to the doctor. Doctor must initial the results before they are scanned into the patients charts." 4. An interview on 9/21/21 at 11:18 am with the TC confirmed the laboratory did not have the test report for Patient #16. 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 --