Medical Group Practice Pc

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 (TC), the laboratory failed to ensure test results were accurately transferred to the patient test report for 1 (Patient 762) of 14 patient test records reviewed. Findings include: 1. A review of the laboratory testing results for Patient 762, tested on 6/10/2021, revealed a thyroid stimulating hormone (TSH) result of 1.4. 2. A review of the final test report in Patient 762 chart revealed the results for the TSH was 2.7. 3. An interview on 5/04 /2022 at 10:34 am with the TC confirmed the patient test report had the incorrect patient test result listed. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #1 (TP1), the laboratory failed to retain quality control documentation when controls failed for 2 (November 2018 to November 2020) of 2 years reviewed. Findings include: 1. On 11/18/20 at 10: 17 am the surveyor observed TP1 performing quality control testing on the Abbott Cell-Dyn Emerald hematology analyzer. TP1 reran level 1 twice and deleted the electronic files of the failed quality control runs. When the runs were printed, TP1 took the failed runs and put them in a separate pile from the successful quality control runs. 2. An interview on 11/18/20 at 10:20 am with TP1 revealed when quality control fails, the laboratory deletes the electronic file of the run and does not retain the printed copy as part of the laboratory's analytic system records. 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 --