Summary:
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 review of two (2) out of ten (10) patients test order requisitions, patients medical records from 11/18/2017 to 01/30/2019 and an interview with a testing personnel, it was determined that the laboratory failed to ensure that the patient final report [Electronic medical record (EMR)] results were accurately entered onto the EMR patient's report as well as pertinent information. 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. The findings included: a. Review of the laboratory's test records (testing requisition, instrument result printouts, and EMR patient reports) revealed that the final test results for the arterial blood gas (ARG) and pertinent information were missing from the following patients' electronic medical records (EMR). The Laboratory Standard Policy & Procedure No. 12-003, pg. 4, XI. Documentation and Communication of Results: "Results of the blood gas analysis are forwarded to the ordering provider." Report Date Acc: # 03/29/2018 10429668 - Missing report in EMR 05/09/2018 10429668 - Missing report in EMR b. On 06/28/2019 12:30 the testing personnel confirmed that patients' electronic medical records did not have Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- either the test results reported or pertinent information to the completion of the testing report per laboratory policies and procedures. . c. Based on the reported estimated annual test volume, approximately 40 arterial blood gas (ARG) patient tests were reported. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on request, review and the lack of documentation for competency assessments, and interview with a laboratory testing, it was determined that the laboratory technical supervisor failed to perform and document the performance of individuals responsible for high complexity testing. The findings included: a. There was no documentation to show that one (1) testing personnel identified as BP of three (3) testing personnel performing Arterial Blood Gas (ARG) was evaluated during the first six months and annually thereafter in 2018. The evaluations must include but are not limited to the following: Direct observations of the testing performed (including sample handling, processing and testing) Monitoring the recording and reporting of results Direct observation of instrument maintenance Review of intermediate worksheets, quality control records. Assessment of testing previously analyzed specimens (external QC and proficiently testing) Assessment of problem solving skills b. The testing personnel confirmed 06/28/2019, 1230 that one (1) of the three (3) testing personnel was not elevated for a competency assessments by the technical supervisor. c. Based on the laboratory's annual testing declaration submitted 06/17/2019, the laboratory analyzed and reported 40 arterial blood gases annually. -- 2 of 2 --