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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.
Diagnosis 2019; aop
Matthew L. Rubinstein
Roots of the total testing process
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;, 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
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:
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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
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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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To more comprehensively support clinical management of patients in our hospital, we redesigned the diagnostic Total Testing Process (TTP) from request to report. To that end, clinical needs were identified and a vision on Total Laboratory Automation (TLA) of the TTP was developed. The Delft Systems Engineering Approach was used for mapping a desirable laboratory testing process. The desirable “To Be” diagnostic process was tendered and the translation of a functional design into a specific TLA-configuration – compliant with the vision and the predefined functional design – was accomplished using a competitive dialogue tender variant (based on art. 29 of the EU guideline 2014/24). Realization of this high-end TLA-solution enabled a high-quality testing process with numerous improvements such as clear and supportive digital request forms, specimen consolidation, track and trace and non-conformity registration at the specimen level, better blood management (∼40% less blood sampled), lean and in line processing with increased productivity (42% rise in test productivity per capita), and guaranteed total turn-around-times of medical tests (95% of TLA-rooted in line tests are reported <120 min). The approach taken for improving the brain-to-brain loop of medical testing, as fundament for better diagnostic stewardship, is explained.
... 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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Clinical laboratory best practice recommendations are increasingly published, some as clinical practice guidelines (CPGs) for support of diagnosis and treatment. However, implementation of guidelines may be diminished by limited planning for computer interpretability during upstream systematic reviews. Systematic review methods that are used to create CPGs, along with approaches for evaluating CPGs, provide no guidance when anticipating downstream needs for computer interpretability and intake into CDSS.
... The paper by Rubinstein on the roots of the term "total testing process (TTP)" [1] provides the opportunity to reappraise the value of laboratory testing, and the role of clinical laboratories in medicine. The first formal definition of TTP, cited by Rubinstein, rightly takes into consideration "all processes and procedures…from the time the patient enters the testing system to the time action is taken by health professional to exert an effect on patient health management and outcomes" [2,3]. ...
Quality assurance and the implementation of a quality management system are as important for veterinary in-clinic laboratories as for reference laboratories. Elements of a quality management system include the formulation of a quality plan, establishment of quality goals, a health and safety policy, trained personnel, appropriate and well-maintained facilities and equipment, standard operating procedures, and participation in external quality assurance programs. Quality assurance principles should be applied to preanaltyic, analytic, and postanalytic phases of the in-clinic laboratory cycle to ensure that results are accurate and reliable and are released in a timely manner.
In medical laboratories, the appropriateness challenge directly revolves around the laboratory test and its proper selection, data analysis, and result reporting. However, laboratories have also a role in the appropriate management of those phases of total testing process (TTP) that traditionally are not under their direct control. So that, the laboratory obligation to act along the entire TTP is now widely accepted in order to achieve better care management. Because of the large number of variables involved in the overall TTP structure, it is difficult to monitor appropriateness in real time. However, it is possible to retrospectively reconstruct the body of the clinical process involved in the management of a specific laboratory test to track key passages that may be defective or incomplete in terms of appropriateness. Here we proposed an appropriateness check-list scheme along the TTP chain to be potentially applied to any laboratory test. This scheme consists of a series of questions that healthcare professionals should answer to achieve laboratory test appropriateness. In the system, even a single lacking answer may compromise the integrity of all appropriateness evaluation process as the inability to answer may involve a significant deviation from the optimal trajectory, which compromise the test appropriateness and the quality of subsequent steps. Using two examples of the check-list application, we showed that the proposed instrument may offer an objective help to avoid inappropriate use of laboratory tests in an integrated way involving both laboratory professionals and user clinicians.
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Background: The number of blood tests ordered in primary care continues to increase and the timely and appropriate communication of results remains essential. However, the testing and result communication process includes a number of participants in a variety of settings and is both complicated to manage and vulnerable to human error. In the UK, guidelines for the process are absent and research in this area is surprisingly scarce; so before we can begin to address potential areas of weakness there is a need to more precisely understand the strengths and weaknesses of current systems used by general practices and testing facilities. Methods: We conducted a telephone survey of practices across England to determine the methods of managing the testing and result communication process. In order to gain insight into the perspectives from staff at a large hospital laboratory we conducted paired interviews with senior managers, which we used to inform a service blueprint demonstrating the interaction between practices and laboratories and identifying potential sources of delay and failure. Results: Staff at 80% of practices reported that the default method for communicating normal results required patients to telephone the practice and 40% of practices required that patients also call for abnormal results. Over 80% had no fail-safe system for ensuring that results had been returned to the practice from laboratories; practices would otherwise only be aware that results were missing or delayed when patients requested results. Persistent sources of missing results were identified by laboratory staff and included sample handling, misidentification of samples and the inefficient system for collating and resending misdirected results. Conclusions: The success of the current system relies on patients both to retrieve results and in so doing alert staff to missing and delayed results. Practices appear slow to adopt available technological solutions despite their potential for reducing the impact of recurring errors in the handling of samples and the reporting of results. Our findings will inform our continuing work with patients and staff to develop, implement and evaluate improvements to existing systems of managing the testing and result communication process.
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Blood gas testing is a commonly ordered test in hospital settings, where the results almost always have the potential to dictate an immediate or urgent response. The preanalytical steps in testing, from choosing the correct tests to ensuring the specimen is introduced into the instrument correctly, must be perfectly coordinated to ensure that the patient receives appropriate and timely therapy in response to the analytical results. While many of the preanalytical steps in blood gas testing are common to all laboratory tests, such as accurate specimen labeling, some are unique to this testing because of the physicochemical properties of the analytes being measured. The common sources of preanalytical variation in blood gas testing are reviewed here.
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For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation of the prevalence of errors in the pre- and post-analytical phases and their potential for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory.
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Little is known about the types and outcomes of testing process errors that occur in primary care. To describe types, predictors and outcomes of testing errors reported by family physicians and office staff. Events were reported anonymously. Each office completed a survey describing their testing processes prior to event reporting. 243 clinicians and office staff of eight family medicine offices. Distribution of error types, associations with potential predictors; predictors of harm and consequences of the errors. Participants submitted 590 event reports with 966 testing process errors. Errors occurred in ordering tests (12.9%), implementing tests (17.9%), reporting results to clinicians (24.6%), clinicians responding to results (6.6%), notifying patient of results (6.8%), general administration (17.6%), communication (5.7%) and other categories (7.8%). Charting or filing errors accounted for 14.5% of errors. Significant associations (p<0.05) existed between error types and type of reporter (clinician or staff), number of labs used by the practice, absence of a results follow-up system and patients' race/ethnicity. Adverse consequences included time lost and financial consequences (22%), delays in care (24%), pain/suffering (11%) and adverse clinical consequence (2%). Patients were unharmed in 54% of events; 18% resulted in some harm, and harm status was unknown for 28%. Using multilevel logistic regression analyses, adverse consequences or harm were more common in events that were clinician-reported, involved patients aged 45-64 years and involved test implementation errors. Minority patients were more likely than white, non-Hispanic patients to suffer adverse consequences or harm. Errors occur throughout the testing process, most commonly involving test implementation and reporting results to clinicians. While significant physical harm was rare, adverse consequences for patients were common. The higher prevalence of harm and adverse consequences for minority patients is a troubling disparity needing further investigation.
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Background: Diagnosis errors are frequent and important, but represent an underemphasized and understudied area of patient safety. Diagnosis errors are challenging to detect and dissect. It is often difficult to agree whether an error has occurred, and even harder to determine with certainty its causes and consequence. The authors applied four safety paradigms: (1) diagnosis as part of a system, (2) less reliance on human memory, (3) need to open “breathing space ” to reflect and discuss, (4) multidisciplinary perspectives and collaboration. Methods: The authors reviewed literature on diagnosis errors and developed a taxonomy delineating stages in the diagnostic process: (1) access and presentation, (2) history taking/collection, (3) the physical exam, (4) testing, (5) assessment, (6) referral, and (7) followup. The taxonomy identifies where in the diagnostic process the failures occur. The authors used this approach to analyze diagnosis errors collected over a 3-year period of weekly case conferences and by a survey of physicians. Results: The authors summarize challenges encountered from their
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The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories. Evidence demonstrates that pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. Most errors are identified in pre-pre-analytic and post-post-analytic steps outside of the laboratory. In a patient-centred approach to the delivery of health-care services, there is the need to investigate, in the TTP, any possible defect that may have a negative impact on the patient. In the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error depends on a laboratory professional (e.g. calibration/testing error) or non-laboratory operator (e.g. inappropriate test request, error in patient identification and/or blood collection). Patient misidentification and problems communicating results, which affect the delivery of diagnostic services, are recognized as the main goals for quality improvement. International initiatives aim at improving these aspects. Grading laboratory errors on the basis of their seriousness should help identify priorities for quality improvement and encourage a focus on corrective/preventive actions. It is important to consider not only the actual patient harm sustained but also the potential worst-case outcome if such an error were to reoccur. The most important lessons we have learned are that system theory also applies to laboratory testing and that errors and injuries can be prevented by redesigning systems that render it difficult for all health-care professionals to make mistakes.
A recent US Institute of Medicine report indicated that up to 98,000 deaths and more than 1 million injuries occur each year in the United States due to medical errors. These include diagnostic errors, such as an error or delay in diagnosis, failure to employ indicated tests and the use of outmoded tests. Laboratory tests provide up to 80% of the information used by physicians to make important medical decisions, therefore it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. A review of the literature and a US Quality Institute Conference in 2003 indicates that errors in laboratory medicine occur most often in the pre-analytical and post-analytical steps in the testing process, but most of the quality improvement efforts focus on improving the analytical process. Measures must be developed and employed to reduce the potential for mistakes in laboratory medicine, including better indicators for the quality of laboratory service. Users of laboratory services must be linked with the laboratorys information system to assist them with decisions about test ordering, patient preparation, and test interpretation. Quality assessment efforts need to be expanded beyond external quality assessment programs to encompass the detection of non-analytical mistakes and improving communication between the users of and providers of laboratory services. The actual number of mistakes in laboratory testing is not fully recognized, because no widespread process is in place to either determine how often mistakes occur or to systematically eliminate sources of error. We also tend to focus on mistakes that result in adverse events, not the near misses that cause no observable harm. The users of laboratory services must become aware of where testing mistakes can occur and actively participate in designing processes to prevent mistakes. Most importantly, healthcare institutions need to adopt a culture of safety, which is implemented at all levels of the organization. This includes establishing closer links between providers of laboratory services and others in the healthcare delivery system. This was the theme of a 2003 Quality Institute Conference aimed at making the laboratory a key partner in patient safety. Plans to create a permanent public–private partnership, called the Institute for Quality in Laboratory Medicine, whose mission is to promote improvements in the use of laboratory tests and laboratory services are underway.
The nine steps in the performance of any laboratory test include ordering, collection, identification (at several stages), transportation, separation (or preparation), analysis, reporting, interpretation, and action.1 Unless the appropriate action occurs, it is as if the cycle had never begun and is, at the most, a tragedy and, at the least, a waste. Several years ago, we coined the phrase "brain-to-brain turnaround time" in which we envisioned a loop such as is shown in the Figure. Anything that interferes with closure of the loop through step 9 leaves an "open loop"—the bane of any decision or information system.2 We have discovered over many years at several institutions that physicians "want what they want when they want it" and that anything that stands in the way of their prompt and perfect receiving of laboratory results for their patients is perceived as a "laboratory problem or error." Thus, matching responsibility
The Total Testing Process is a multistep process that begins and ends with the needs of the patient. Identifying the many steps in the Total Testing Process and planning and using an interdisciplinary team to begin a coordinated effort will improve the process and offer optimal patient care. Communication among departments and developing interdepartmental guidelines will improve the use, sampling, performance, and interpretation of health assessment procedures. A commitment to the continuous improvement of patient assessment will require the participation of numerous health professionals. It is time for every institution to bring individuals together, collectively identify solutions, implement an improvement plan, and evaluate the effectiveness of their efforts using outcome measures that both directly and indirectly relate to improved patient care. Doing it right the first time will benefit the patient and conserve our limited health-care dollars.