Case Study College of American Pathologists. All rights reserved. cap.org

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1 Case Study How to Reduce Clerical Errors Mark Shearer, MCLT, MT(ASCP) Director of Chemistry, CompuNet Clinical Laboratories Clerical errors represent the single largest source of errors on proficiency testing (PT) samples. Between 2007 and 2011, the College of American Pathologists (CAP) identified clerical errors as the primary reason for a CAP PT or Surveys failure, as noted in nearly 40 percent of the CAP s Proficiency Testing Compliance Notices (PTCNs). The number is staggering, because almost none of these clerical steps is required when testing patient samples. PT s goal is to ensure the accuracy of a laboratory s test results, not its ability to complete forms and code data. New processes and self-checks can reduce these non-patient-related clerical errors. One of the requirements in the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) states The laboratory must test the samples in the same manner as patients specimens. (Sec ) Over the years the CAP has made progress in the area of how it provides PT samples to the laboratory. Many of the serum samples are now liquid, eliminating errors associated with sample hydration. Cell count samples are now delivered in tubes, enabling a laboratory to access them just as it would access the vast majority of patient samples. Advancements in sample-handling have greatly reduced some errors; however there was still room for improvement. Approximately five years ago, CompuNet Clinical Laboratories began researching the sources of error with its CAP Surveys responses and it was determined that the errors fell into two categories: technical errors and clerical errors. CompuNet deemed the clerical errors to be avoidable and immediately focused its efforts on ways to greatly reduce or eliminate them. CompuNet Clinical Laboratories was not alone in finding that clerical errors caused a majority of reported deficiencies. As mentioned earlier, clerical errors accounted for nearly 40 percent of PTCNs from This is remarkable as PTCNs are only generated when two or more challenges of a given analyte are cited as unacceptable. The reported figure would be significantly higher if the statistics included all the single failures due to clerical errors. Errors on proficiency testing (PT) samples fall into two categories: technical and clerical. Clerical errors are avoidable, yet represent the single largest source of errors and cause a majority of reported deficiencies. CompuNet identified several causes for the clerical errors. Clerical errors increased as the volume of results entered on some CAP Surveys increased (200+ on the CAP s CHM Survey alone). Surveys for which a laboratory must report two instruments further increase the likelihood of errors in result reporting. It was noted that the order of the analytes on reports did not match the order listed on the CAP result form. As the number of analytes on a PT challenge increased, the number of clerical errors increased. Laboratory staff found that incorrect or missing decimal points, incorrect units, and incorrect method or instrument codes contributed to clerical errors. CompuNet staff also found that failure to submit results was a cause for cited deficiencies. Staff considered this a clerical error because the error was related to a manual process unique to PT samples and not to its patient samples.

2 Current Options CompuNet s investigating team determined that the first step in the process of preventing these types of errors involved creating a process map that showed the steps taken to ensure that the laboratory completed all of its paperwork correctly. A company-wide procedure existed that specified how to perform these steps; however, steps had been added over the years to address our laboratory errors and errors uncovered when performing CAP laboratory inspections at other laboratories. The following process map illustrates the typical flow related to the transcription of PT results: Gather Data Transcribe Enter Data Instrument printouts Worksheets LIS reports CAP forms Survey Companion Form Organize printouts Copy results to the CAP form Verify instrument/method codes Verify units of measure Key data into e-lab Solutions and save data Verify Data Entry Double Check Submit Give paperwork to someone else They verify the data in e-lab Solutions If any correction was made as part of the last step, have third person review and verify the data entry Once all the reviews have taken place, submit data via e-lab Solutions Note: The Surveys Companion Form is a document that the laboratory developed to track and document all the steps involved in receiving, processing, and submitting PT samples.

3 Approximately 90 percent of these steps are only performed on PT samples and not on clinical samples. Clearly clerical errors can occur in many places, and a laboratory can spend considerable time in checking and double-checking data entry. This process results in a lengthy delay between testing and releasing results. What can take only a couple of minutes for a clinical sample (seconds if auto-verifying results) can take hours to do for PT samples. Due to the need to check and double-check data entry, the laboratory usually spreads out the process over two to three days. These delays have resulted in missing submission deadlines. All of this comes at a price, including time spent performing duties not directly related to patient care. With the CAP s new e-lab Solutions Connect, we will save more than 500 hours of staff time annually, time that would have been spent inputting PT results for our 347 challenges. We will save $18,000 in staff time in the first year alone. More importantly, we will be able to redirect and better allocate our staff to more profitable and productive, patient-centric activities. The New Connect Option CompuNet s laboratory team built processes to minimize the possibility of clerical errors, however it was recognized that outside resources could further improve our processes. Fortunately, the CAP and Data Innovations (DI) recognized the need for a more efficient means by which proficiency testing data is entered into e-lab Solutions. DI offers a product called Instrument Manager (IM). Not only is it capable of transmitting orders and results to and from laboratory instrumentation, but it can also review and manipulate the data if necessary. CompuNet had been using this software for six years as a means to interface instruments to two separate laboratory information systems (LIS), and it has also been instrumental in quality assurance (QA) and auto-verification processes. With an ability to receive, reformat, and resend data, IM was a natural solution to bridge the gap between CompuNet s instrumentation and CAP s e-lab Solutions. In early 2011, the CAP asked CompuNet to participate in a pilot project, e-lab Solutions Connect, to design, develop, and test a process for the entering of PT results that virtually eliminates clerical errors and very closely mirrors the processes used for patient samples. Throughout the process, the laboratory team focused on developing a solution that not only matched the processes used for patient samples but also was relatively self-sustaining once the initial database was constructed. On January 30, 2012, the process officially went live and on February 1, the first set of PT results was electronically submitted into e-lab Solutions. With the CAP s new e-lab Solutions Connect, we will save more than 500 hours of staff time annually. We will save $18,000 in staff time in the first year alone. More importantly, we will be able to redirect and better allocate our staff to more profitable and productive, patient-centric activities. - Mark Shearer, MCLT, MT(ASCP) Director of Chemistry, CompuNet Clinical Laboratories

4 The process works as follows: (1) The PT samples are logged into the LIS using the specimen ID and kit number as identifiers. (2) The samples are processed following normal procedures. When the results are sent from the instrument, IM processes the results as it would a patient: it identifies critical values and looks for error flags and unusual results that would require follow up, thus ensuring that the results are handled just like patent samples. Once this review is complete, IM recognizes these as PT samples and, in addition to sending the results to the LIS, IM also sends them to the CAP server using a predefined file structure. Logical Observation Identifiers Names and Codes (LOINC ) codes are used to identify the analyte to the CAP and the unique identification of PT samples ensures that no patient results are sent to the CAP. The receipt of the results is immediately identified in e-lab Solutions, which then validates the results to ensure that the correct result is filed in the correct spot, accounting for decimal points, measuring units, and even handling less than and greater than flagging when it is available on the results form. Validation and filing of results takes roughly 30 minutes during which the end user cannot access the results form through e-lab Solutions; however, once it is complete, all the results are filed and are ready for approval. The system can also accommodate primary and secondary instrument results from the same challenge and file them into the correct location. The new process map is illustrated below: Gather Data LIS reports Survey Companion Form Review Review Instrument/Method codes Review results Submit Approve via e-lab Solutions What once took up to 19 steps and hours of a supervisor s time over a couple of days now takes seven steps and about 30 minutes with no manual labor. Eliminating manual data entry has saved the laboratory money and allows supervisors to focus more time on their management responsibilities. By developing e-lab Solutions Connect, the CAP and Data Innovations have helped eliminate all of the tediousness of keeping everything in order and making sure I was putting the correct results in the correct column, stated Kelly Richards, Hematology Technical Specialist.

5 In addition to the time savings, this process eliminates most possibilities for clerical errors. While it is still possible to use the wrong instrument/method code, e-lab Solutions maintains the last code used; as long as there is not an instrument or reagent change, no additional action is required. It is also still possible to mislabel the PT samples and thus incorrectly submit the data. However, this can also happen with patient samples, too. Each laboratory should continue to follow their standard processes to prevent this type of occurrence. e-lab Solutions Connect streamlines the process, eliminates most chances for clerical errors, and makes proficiency testing a whole lot easier. - Lisa Berger, Site Director While the Hematology Automated Differentials FH Series Survey was the first PT challenge to be submitted by e-lab Solutions Connect, the General Chemistry and Therapeutic Drugs Surveys have also been submitted via this process. Checking the last General Chem/TDM survey was as smooth as butter. I didn t spend time transcribing the instrument printout results to the original CAP Surveys forms, rechecking what I had transcribed and entering those results into the CAP web site. Clerical errors were almost non- existent, states Jan Scott, CompuNet s Hospital Chemistry Manager. Sandy Frommeyer, CompuNet s Reference Chemistry Manager, echoed this sentiment: For the C-A Survey, not having to hand enter over 350 results was a God-send! Even the second review of results went faster. The CAP e-lab Solutions Connect project provided a means to remove most clerical errors from the data submission process for PT samples. This laboratory QA breakthrough was accomplished through the joint effort with CompuNet Clinical Laboratories, DI, and the CAP. CompuNet staff is very pleased that the DI Instrument Manager software reviews PT results the same way it reviews patient samples and then submits the data electronically to CAP s e-lab Solutions. The software performs all the data entry steps into the PT submission forms. The end user only need review and release the results, just as they would with patient samples.