APHL 2019 POSTER ABSTRACTS
Quality Systems
Analytical Results Can Only Be as Good as the Test Portion!
N. Thiex 1 , A. Price 2 , Y. Salfinger 3 , 4 , J.M. Cook 5 , H. Hickes 6 , L.
Novotney 7 , C. Ramsey 8 , M. Swarbrick 9 , S. Webb 10 ; 1 Association of
American Feed Control Officials, 2 Canadian Food Inspection Agency,
3
Association of Food and Drug Officials, 4 Association of Public
Health Laboratories, 5 Jo Marie Consulting, 6 Montana, 7 South Dakota
Agriculture Laboratory, 8 EnviroStat, Inc., 9 Minnesota Department of
Agriculture, 10 University of Kentucky, Division of Regulatory Services
Presenter: Robyn Randolph, Association of Public Health
Laboratories, Silver Spring, [email protected]
Update on the Online Course to Help Laboratory
Professionals and Healthcare Providers Improve Preanalytic
Processes of Biochemical Genetic Testing
B. Chen 1 , B. Su 2 ; 1 Centers for Disease Control and Prevention,
2
Association of Public Health Laboratories
Introduction: Biochemical genetic tests are associated with a wide
range of preanalytic variables, including test selection and ordering,
patient conditions, quality and timing of specimen collection, handling
of test requests and specimens by referring laboratories, specimen
transport, and communications with healthcare providers, patients,
and collaborating laboratories. Studies have shown that the preanalytic
phase might be the most error-prone during the total testing process in
many laboratory disciplines including genetic testing.
Method: CDC published a guideline “Good Laboratory Practices
for Biochemical Genetic Testing and Newborn Screening for
Inherited Metabolic Disorders” in 2012 (http://www.cdc.gov/
mmwr/pdf/rr/rr6102.pdf). Since 2013, CDC has been collaborating
with the Association of Public Health Laboratories (APHL) to
help genetic and newborn screening laboratories in their quality
improvement activities. Findings from two discussion groups held
in 2013 identified a need for training to supplement the guideline
(https://www.aphl.org/aboutAPHL/publications/Documents/
CDCRecommendationsGoodLabPractices_OCT2014.pdf). To meet
this need, an online training course titled “Good Laboratory Practice
Recommendations for Biochemical Genetic Testing: Preanalytic
Phase” was developed under the APHL-CDC cooperative agreement
to help laboratory professionals and healthcare providers improve
preanalytic practices for biochemical genetic testing.
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LAB MATTERS Summer 2019
Conclusions: The quality improvement practices discussed in this
course are helpful not only for biochemical genetic testing but also
for many other laboratory areas. Knowledge improvement and
evaluation results will be continuously monitored to assess the
effectiveness of this online course and to inform future training
development needs.
Presenter: Bertina Su, Association of Public Health Laboratories,
Silver Spring, MD, [email protected]
New Online Course on Analytical Validation of a
Biochemical Genetic Test Using Liquid Chromatography —
Tandem Mass Spectrometry
B. Chen 1 , B. Su 2 ; 1 Centers for Disease Control and Prevention,
2
Association of Public Health Laboratories
Introduction: Biochemical genetic tests are highly specialized
laboratory procedures for the evaluation, diagnosis, and clinical
management of inherited metabolic diseases. Over the last two
decades, the advent of expanded newborn screening for inherited
metabolic disorders using tandem mass spectrometry (MS/MS)
and other technologies has presented an increasing demand
for biochemical genetic testing in diagnosing presumptive cases
detected through newborn screening. However, biochemical genetic
tests are highly complex procedures performed on a wide variety
of patient specimen types. Biochemical genetics laboratories need
easily accessible training materials in developing and implementing
new tests using the MS/MS technologies.
Method: Since 2013, CDC has been collaborating with the Association
of Public Health Laboratories (APHL) to help genetic and newborn
screening laboratories in their quality improvement activities.
Findings from two discussion groups held in 2013 identified topic
areas in which training resources are desired, including user-friendly
online courses on developing and validating new test procedures.
(https://www.aphl.org/aboutAPHL/publications/Documents/
CDCRecommendationsGoodLabPractices_OCT2014.pdf). To meet this
need, experts in biochemical genetic testing and MS/MS technologies
were enlisted to develop a new online course titled “Validating a New
Test Using Liquid Chromatography - Tandem Mass Spectrometry
(LC-MS/MS) in a Biochemical Genetics Laboratory.” Pilot testing was
conducted by laboratory professionals to ensure its usefulness for the
target audience.
PublicHealthLabs
@APHL
APHL.org
Laboratory activities are focused on analytical methods, and
often insufficient consideration is given to the selection of the
test portion. Equal attention should be paid to the selection of the
test portion, as it generally introduces substantially greater error
than analytical error. Representative sampling requires control of
all errors. The types and sources of error in laboratory sampling,
as well as approaches for mitigating the errors, are addressed in
the publications entitled “Guidance on Obtaining Defensible Test
Portions” or “GOOD Test Portions.” Laboratory sampling should also
not be overlooked in the in the laboratory quality system. In some
cases, quality assurance and quality control will be similar to what
is incorporated for analytical methods, and in other cases, it will be
fundamentally different. Approaches for validation and verification
of sampling protocols and appropriate quality control events can
also be found in “GOOD Test Portions.”
Results: This multimedia online course has been publicly available
on CDC TRAIN website at https://www.train.org/cdctrain/
course/1072447 since December 2017. The course consists of
3 lessons on quality assurance for test requisitions, specimen
collection and submission; laboratory-clinician communications;
and preanalytic quality assessment. Several case scenarios are
included to illustrate how the recommended practices can be used
to improve preanalytic quality and patient outcomes. Continuing
education credits are available from this course free of charge,
including 1.5 hours of the ASCLS P.A.C.E. credit and 1.5 contact
hours for Florida Laboratory Licensees. As of September 25, 2018,
119 learners have completed the course with post test scores
averaging 97%, reflecting a significant knowledge improvement
from their average pre-test scores (63%). Approximately 89% of the
participants stated that this training course addressed a gap in their
knowledge or skills.