How to Reduce Clerical Errors - College of American Pathologists

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Case Study
How to Reduce Clerical Errors
Run Proficiency Testing As If Testing a Patient Specimen
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. 493-801) 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
2007–2010. 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.
© 2012 College of American Pathologists. All rights reserved.
cap.org
Case Study: How to Reduce Clerical Errors
College of American Pathologists
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
•
•
•
•
•
Instrument printouts
Worksheets
LIS reports
CAP forms
Survey Companion Form
Transcribe
•
•
•
•
•
Organize printouts
Copy results to the CAP form
Verify instrument/method codes
Verify units of measure
Complete Survey Companion Form
Enter Data
• Key data into e-LAB Solutions and save data
• Complete Survey Companion Form
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.
cap.org
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
cap.org
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.
cap.org
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.
cap.org

How to Reduce Clerical Errors - College of American Pathologists

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