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By Dawn R. Maghakian
10/09/07
FOCUS on Quality Improvement in Molecular Pathology
Dawn R. Maghakian M.S., MP(ASCP), CLSp(MB)
When we catch an error, we see more clearly how we can prevent it. In the
clinical laboratory, there is no room for error where information can result
in an immediate or dire consequence in clinical decision making. In molecular
pathology, we can have a profound effect and must ensure we recognize mistakes
early and prevent them from occurring in the future. FOCUS PDCA is a great
tool to accomplish this goal.
The Deming Cycle Plan-Do-Check-Act (PDCA) model is similar to a quality improvement
(QI) Six Sigma method to define, measure, analyze, improve, and control (DMAIC).
Originally, the Hospital Corporation of America (HCA) developed an algorithm
blending these scientific methods with a quality management (FOCUS) plan, utilizing
PDCA and defining the following steps:(1-3)
F - Find the problem.
O - Organize a team familiar with the process.
C - Clarify current processes.
U - Understand sources of variation.
S - Select a specific process improvement (PI).
Regardless of the acronym, using a systematic method for PI can be very useful.
For instance, encountering an error, such as an incorrect genotype report,
demonstrates “finding a problem.” The next step to prevent this
is to build a team. Let’s say the report was a false positive heterozygous
mutant result. Your team should include pre-analytical, analytical, and post-analytical
members depending on where the error occurred in the process and what contributed
to it.
Further analysis involves clarifying what you currently use to prevent this
error. You might have two technologists evaluate all results before they are
released. However, if the error could not have been prevented by this review
then you have identified a process to improve. Take, for instance, a case where
results are entered on Sample A and Sample B using a de-identified accession
number that is unique to each sample. Let’s say that Sample A was negative
for mutation and Sample B was heterozygous but when the samples were accessioned,
they were assigned the same accession number (pre-analytical error). Without
a process in place to recognize that duplicate assignment of an accession number
can occur. Absent a method to uniquely identify samples without relying only
on the accession number, a technologist may not catch the error on test set
up (analytical error). When the results are entered, there is no certainty
as to which sample was tested in which order to assure that the correct result
is reported, especially if the error is caught only after the results have
been entered into the lab information system (post-analytical error).
In this example, then, we understand that the variation may have come from
either the order or the method of accessioning, testing, or resulting. In selecting
the process to improve, it is important to select one that encompasses all of
this potential variation.
Once you have followed the FOCUS model for your QI troubleshooting process,
you then move onto the PDCA cycle to implement and maintain your desired change.
To continue with our example we may select the following:
Process to improve: Correct test result entry for mutation
analysis.
Team members: Accessioning staff, technical staff, supervisor,
director.
Plan: All samples received for testing will be accessioned
one at a time and placed in a logical order into the sample rack. The technologist
setting up the assay will check each sample using three unique identifiers
prior to DNA extraction. At result entry, two technologists will verify the
correct result entry using three unique identifiers prior to release of the
result.
Do: Over the course of the next three months, all of the
above recommendations should be implemented. Documentation is enforced to
demonstrate order and method compliance.
Check: Periodically random chart review is carried out over
the three months to ensure compliance. After the designated time period,
all results are again verified that no error has occurred.
Act: If successful, the steps implemented are continued
or you return to the planning stage to initiate another cycle of continued
QI.
References:
1. Jacks, Ruth (2003), “Six Sigma: PDCA on Steroids?” iSixSigma.com.
Retrieved Sept. 5, 2007, from http://healthcare.isixsigma.com/library/content/c030624a.asp
2. Coutts, B. & Herzeberger, S. (2005), “Performance
Improvement: A Change for the Better,” RN.com. AMN Healthcare Inc.
CE article Retrieved Sept. 5, 2007 from http://www.rn.com/getpdf.php/714.pdf
3. Stanford Hospital & Clinics website. Retrieved Sept.
5, 2007 from http://www.stanfordhospital.com/QIPS/QIPSDept/FocusPdca
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