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Roots of the total testing process

DOI:10.1515/dx-2019-0065
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Matthew Rubinstein at Rutgers, The State University of New Jersey
Matthew Rubinstein
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Abstract

Laboratory professionals can contribute to improvement of diagnosis in the context of the total testing process (TTP), a multidisciplinary framework complementary to the diagnostic process. While the testing process has been extensively characterized in the literature, needed is accurate identification of the source of the term "total testing process". This article clarifies first appearance of the term in the literature and supplies a formal definition.
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Diagnosis 2019; aop
Point/Counterpoint
Matthew L. Rubinstein
Roots of the total testing process
https://doi.org/10.1515/dx-2019-0065
Received September 5, 2019; accepted September 11, 2019
Abstract: Laboratory professionals can contribute to
improvement of diagnosis in the context of the total test-
ing process (TTP), a multidisciplinary framework com-
plementary to the diagnostic process. While the testing
process has been extensively characterized in the litera-
ture, needed is accurate identification of the source of
the term “total testing process”. This article clarifies first
appearance of the term in the literature and supplies a for-
mal definition.
Keywords: clinical laboratory; diagnostic process; total
testing process.
Laboratory professionals (e.g. clinical laboratory scientists)
can contribute to improvement of diagnosis in the context
of the total testing process (TTP), a multidisciplinary
framework complementary to the diagnostic process [1,2].
While the testing process has been extensively character-
ized in the literature [3–9], needed is accurate identifica-
tion of the source of the term “total testing process” along
with formal definitions, as citations in the literature appear
circular and without ultimate attribution.
Systematic approaches for localizing and addressing
laboratory medicine process errors extend back to many
decades [10, 11]; however, the concept framework of the
“total testing process” was formally developed during a
1986 and 1989 Institute on Critical Issues in Health Labo-
ratory Practice hosted by the Centers for Disease Control
and Prevention [12, 13]. An electronic version of these
proceedings is located in the Open Science Framework
(OSF; https://osf.io), project Roots of the Total Testing
Process. Within these proceedings, the term “total
testing process” makes its first appearance in the litera-
ture, with the formal definition as follows: “the combi-
nation of all processes and procedures, coupled with the
interactions of all personnel and available technology
involved in the testing from the time the patient gains
access to the testing system to the time action taken by
the health professional exerts an effect on health out-
comes” [12, 13].
As a concept framework, the TTP reinforces that
laboratory testing is a collaborative patient intervention
with the goal of individual patient as well as popula-
tion health – therefore an important framework when
addressing diagnostic error with laboratory involve-
ment. It is important to note, however, that not all
issues in the diagnostic process are situated in the TTP,
nor are all efforts to improve the TTP directly relevant to
improvement of diagnosis. Further, improvement oppor-
tunities will vary in the degree of control and influ-
ence by participants, while terms such as total testing
process error or test cycle error (vs. laboratory error)
may be more generalized across testing pathways, invit-
ing multidisciplinary perspectives, accountability, and
improvement.
In sum, the TTP has been formally defined in the
following ways:
1. A systems-based framework for examining all pos-
sible interactions and activities that can affect the
quality of tests. It is the combination of all processes
and procedures, coupled with the interactions of all
personnel and available technology involved in the
testing from the time the patient gains access to the
testing system to the time action taken by the health
professional exerts an effect on health outcomes.
Note: the resource for citation 14 is also located in the
aforementioned OSF project) [12, 14].
2. A conceptual framework consisting of all components
that complete the laboratory testing cycle, from the
point of the clinical question to the point of clinical
action, known as the brain-to-brain model. It is defined
by the activities in three distinct phases that align with
clinical workflow outside and inside the laboratory:
preanalytic, analytic, and postanalytic. This concep-
tual framework can aid (a) in design and implementa-
tion of interventions, restrictions, and limits that can
reduce or eliminate errors that adversely affect testing
and patient health outcomes, and (b) in understand-
ing the dynamics of laboratory medicine as well as
quality measures to improve care [15].
Matthew L. Rubinstein, Rutgers Biomedical and Health Sciences
Lecturer, Rutgers University, Clinical Laboratory and Medical
Imaging Sciences, School of Health Professions, 65 Bergen Street,
GS-01, Newark, NJ 07103, USA, E-mail: matt.rubinstein1@gmail.com
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2      Rubinstein: Roots of the total testing process
Author contributions: All the authors have accepted
responsibility for the entire content of this submitted
manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Author declaration: This paper is exempt from ethical
approval.
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... The Total Testing Process (TTP) has recently been reappraised as "a set of interrelated or interacting activities that transform biologic patient sample materials into laboratory results and information to ultimately assure the most appropriate clinical outcome" [1]. Plebani and other key opinion leaders advocate that there are nowadays several reasons for counteracting the 20th century vision of the medical laboratory as a commodity, only focusing on cost reduction and economy of scale [2][3][4][5][6][7][8][9]. Also, in this era of precision medicine and digitalization lab professionals are facing "disruptive" changes. ...
... The lab specialist staff explicitly aimed to move from a compartmentalized, workstation-oriented approach toward a TLA-centric change, conformant to Delfts System Engineering, and enabling continuous reinforcement of TTP outcomes and perspectives [1][2][3][4][5][6][7][8][9]. To that end, process optimization and simplification of the entire brain-to-brain loop, with complete decompartmentalization of the former diagnostic processes from separate 24/7 units into one integrated process for patient care and for supporting clinical research, was strived for. ...
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... Therefore, guidelines that related only to patient treatment or patient management procedures, without obvious relevance to the clinical laboratory, were excluded. These judgments were aided by the total testing process framework and by Behal's (2006) conceptual approach for linking guidelines on healthcare conditions to laboratory testing and laboratory process indicators [13][14][15]. In some cases, articles broadly mentioned patient "screening" methods as part of modeling the development and deployment of computer-interpretable clinical practice guidelinesarticles with very broad descriptions like these were excluded. ...
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