Attieh,  E.,    Capron,  F.  and  Brézillon,  P.  (2013)  Context-­‐based  modeling  of  an  ACP  Departement  for  elimina-­‐ting  nonconformity.  In:  P.  Brézillon,  P.  Blackburn,  and  R.  Dapoigny  (Eds.):  CONTEXT  2013,  LNAI  8175,  pp.  235-­‐247.  ©  Springer-­‐Verlag  Berlin  Heidelberg  2013  

Context-based Modeling of an Anatomo-Cyto-Pathology Department Workflow for Quality Control

Elham Attieh1, 2, Frédérique Capron2 and Patrick Brézillon1

1LIP6, University Pierre & Marie Curie (UPMC) 2UIMAP, Department of Pathology, Groupe Hospitalier Pitié-Salpêtrière, APHP

elhamattieh@hotmail.com, patrick.brezillon@lip6.fr, frederique.capron@psl.aphp.fr

Abstract. The paper presents the contextualization of the Anatomical pathology (AP) workflow focusing on nonconformity during the reception and registration steps. Context is described by contextual elements related to heterogeneous sources such as the actor, the task, the situation and the local environment. The objective of this work is the application of contextual graph to the "workflow" of an AP exam, limited to the steps of reception and registration. The main point is the context-based representation of practices developed by actors in-stead of an object-centered view on the workflow to identify and ultimately avoid risky practices leading to nonconformity and prejudice. Therefore contex-tual graph can be considered as a tool for monitoring the quality of work in an AP department, the actions, detection and correction of nonconformities as well as a base for intelligent software creation that links different modules in medi-cal care.

Keywords: Workflow, contextual graphs, contextual element, nonconformity, reception, registration, anatomical pathology, medicine, quality control.

1 Introduction

Anatomical Pathology (AP), named in France Anatomical and Cytological Pathology (ACP) is a medical specialty unknown to the public but essential in oncology [1]. AP aims to examine macroscopically, but also microscopically, patients’ tissue samples and cells in order to establish the diagnosis and the factors of severity of the disease, contributing thus to medical care [1], [2]. AP physicians follow procedures that in-clude a gross examination (visual examination of organs), dissection and sampling of surgical specimens according to standardized protocols and then a microscopic exam-ination of stained tissue sections. AP is a medical activity based on normal anatomy, histology and cytology to identify, by analogy, macroscopic and microscopic morpho-logical abnormalities. It performs several techniques such as immuno-histochemistry, cytogenetic and molecular to identify abnormalities in cells or tissues [2]. The process begins with a request form associated to a sample. All over the workflow each action

and information collected is integrated in the laboratory information management system (LIS) file related to the AP exam. The latter is a part of the patient’s medical data conditioning his medical chart. Therefore the Pathology Advisory Committee, formed in 2008 by the direction de la lutte contre le cancer, aims to identify key is-sues in pathology and suggest specific interventions for the ongoing improvement of quality in accordance with the principles of evidence-based medicine [3]. While con-formity is the fulfillment of a requirement, nonconformity is defined as “the failure to fulfill the requirements of a standard, in whole or in part” which may be prejudicial to the patient. We distinguish two categories of nonconformities: critical nonconformity and non-critical nonconformity. A critical nonconformity is “the failure to fulfill the requirements blocking the process of the sample examination”, while a non-critical nonconformity does not lead to a sample rejection [2].

Beyond this large spectrum of data, information and knowledge about the prob-lem, external events intervene such as the type of task to accomplish, the actor realiz-ing the task (technician, pathologist…), the situation in which the task is realized and the available resources in the immediate environment. Such contextual elements may impact the task realization. If they are not integrated in the reasoning, this could lead to nonconformity. Thus, this work aims to (a) represent exams in AP as a workflow, and (b) identify the practical limits of this representation.

Focusing on nonconformity during the steps of the process, we look for risky points at each step. Any bad decision at one step may cause a cascade of undesirable events, or even be visible only at a late step. For example, during an examination, a pathologist may refer or not to immunohistochemistry or special techniques or stains to make a diagnosis. The degree of variation may be inconsequential, and more im-portant, create a nonconformity. Therefore task automation in the AP department is limited because it depends largely on human decision-making, especially in the recep-tion/registration area where actors rely implicitly or explicitly on many contextual elements to decide which actions must be done. The decision-making process in-cludes assembling, organizing, structuring a large number of heterogeneous contextu-al elements, and finally builds an action sequence.

The complete trace of an AP’s examination (mainly the reasons on which is based on a decision or an action at the different steps of the process) is rarely recorded. The focus is on the result (or the conclusion), not on the process leading to it, the latter relying heavily on the working context. Thus, when a nonconformity situation occurs, it is difficult to identify the reason of nonconformity, to correct the problem and to learn how to avoid it again.

Making the contextualization process explicit supposes to use a formalism provid-ing a uniform representation of elements of knowledge, reasoning and context. Con-textual Graphs are such a context-based formalism of representation [4] that is im-plemented in a piece of software called CxG_Platform [5]. Thus, the representation of the task realization in a AP Department as a contextual graph becomes a contextual-

ized workflow. Each path in this graph represents a practice as sequences of contextu-al elements and actions. Thus, the task is represented as an organization of practices structured by contextual elements (i.e. the contextual graph). Such a representation is well adapted for modeling AP’s examination workflow.

In this paper Section 2 introduces the sample orientation in AP department and the quality in AP. Section 3 discusses Contextual elements and Contextual-Graphs for-malism for representing the modeling of AP’s examination. The results with the con-textual graph that we have obtained are detailed in section 4. Section 5 offers a dis-cussion of these results while section 6 proposes some new challenges to address.

2 Dispatching of Sample Examination in AP Department

Our work is based on the workflow in the AP Department of the Pitié-Salpêtrière Hospital (APHP, France) from the arrival of the sample and request form at the recep-tion bench to the AP report sent to the referent physician (Figure 1).

 Fig. 1. AP Examination workflow at the Pitié-Salpêtrière AP department

In this paper we discuss the two first steps, namely the reception area and the reg-istration area as presented Table 1, the procedures of the department and the different actors doing their daily work. Our study concerns the different contextual elements that influence actions in the reception and registration activities.

2.1 Sample and Request Form at the Reception and Registration Bench

Samples and request forms reach our AP department by two possible paths: • Received by the pneumatic system, from the clinical wards, operating rooms or

from the sorting center; and

• Carried by a messenger from the sorting center or operating rooms: delivery of large surgical specimens and samples from other services not connected to the pneumatic.

A request form is attached to each sample, which is a paper document and therefore not yet computerized. The technician takes in charge the sample and the request form. The technician stamps the date and the time of the reception on the request form and checks the conformity of both the sample and the request form.

Conformity of the Request Form. The conformity of a request form is warranted if all the following fields are filled: 1. The identification label of the patient (first and last name), 2. The date and time of completion of the sampling, 3. The time of fixation of the sample if known, 4. The nature of the samples or slides (marked when multiple samples are sent), 5. The clinical diagnosis (known or suspected), 6. Identification (Stamp and / or signature) of the responsible physician who made the

sample or the doctor who asked for it.

Conformity of the Sample. The sample is correctly identified if: 1. The sample’s pot is labeled with the patient’s identification as on the request form, 2. Indices are noted on the pots if the package contains several specimens as marked

on the request form, 3. The sample has the right conditioning for adequate processing.

If sample and request form are conform, the technician must: • Assign a number for the examination, by sector, through the department manage-

ment system, • Paste the number in the upper right of the request form, • Paste this number on the pots according to the indexes assigned, • Write the number on the slides (smear, FNA), • Write the number of pots, tubes or slides received on the lower part of the request

form, in the section reserved to the laboratory, • For samples oriented to the gross examination, put the stamp where the medical

sector will appear after registration, • When an application contains jointly cytology and surgical specimens or biopsies,

renumber bottles and reindex the request form giving cellular samples (Fluid) let-ters and tissue samples numbers. Then, photocopy the request form (or give the double) and transmit to the Cytology section,

• Sign the request form at the bottom left, • Note a fresh sample on the request form and prevent the duty doctor.

Nonconformity at the Reception and Registration Steps. Nonconformity (NC) concerns the request form and the sample. The NC that does not block the completion of the examination must be declared to the sender department, and involved anomalies are recorded through a keyword entered in the computer file. NC that blocks the completion of the examination requires that a form is filled to explain the reasons and the technician must accomplish the following actions: • Alert the sender department and the responsible physician who should come to

correct the nonconformity, • Assign a number "N" on nonconformity sheet and request form (top left), • Fill the nonconformity form completely and legibly, • Save in LIS "Registering of a nonconformity", • Scan and file the form, • Final decision taken by the Head of the Pathology department. Once the reception part completed, the same technician that has taken in charge the sample initially will proceed with the registration task. The technician now must: • Select the medical sector, corresponding to the medical dispatching of the duty, • Enter the barcode number of the examination, • Enter the patient identification number (PIN) and confirm the patient's identity, • Enter the source of the sample; therefore refer to the label on the request form. In

the absence of the latter, do a search on Gilda (AP-HP patient’s identity manage-ment system),

• Put a X unless a prescriber is already pre-recorded, • Date the request form; if no date is specified, put the actual date of the day, • Enter the code of the pathology exam (referring to a table of AP acts affected to

APHP AP structures), • Specify the exact nature of the sample and the number of slides or pots in the tab

“further examination”, • Select the Medical Sector Activity (MSA), • Check the sheet bench (for printing) for cytology tests or complex examination

(multiple pots) for the gross section, • Check the anteriority in the AP department, • Confirm with the OK box at the bottom of the screen, • Note the MSA on the request form for samples dispatched to gross examination

room, • Carry samples and request forms to: cytology, frozen section or fresh tissue, gross

examination, cassette processing room, and • Scan the request form. Actions in the reception/registration step depend on human made decision, which is based on training, competence and experience.

2.2 Workflow Information in a Table Representation

According to WHO [6], and concerning health institutions, a quality process guaran-tees to each patient an assortment of diagnostic and therapeutic acts, which ensures the best result in terms of health. This supposes that all actors adhere to rules and standards to find out who did what, how and why. Therefore, it is required to elabo-rate recommendations, written procedures and protocols, to guide the workflow and for the quality control.

Table  1.  Workflow  table  at  reception  and  registration  areas  of  Pitié-­‐salpêtrière  AP  Dpt.  

 First, the components of the AP department’s workflow were identified. Table 1

presents a part of the initial workflow in terms of location, task to realize, actors that are concerned, laboratory identification system (LIS) and connection systems with the hospital information system and constraints. This table is an important tool that high-lights and identifies the different key elements in the reception/registration step, for instance, to identify the task and who is doing it.

3 Contextual Elements in the Workflow of the AP Department

Contextual elements come from heterogeneous sources: the actor, the task, the situa-tion and the local environment [7]. In this study, contextual elements concern the functioning of an AP Department, focusing mainly on nonconformity and related domain knowledge. The reception and registration areas are crucial steps in the work-

flow of sample examination because it is the first step in the chain of actions of actors. Occurrence of nonconformity at this level could lead to a whole series of inadequate actions. Thus, there is an important challenge to limit as much as possible these risky situations by detecting them at the source (information meetings, observation and controls…). Such measures are necessary conditions, but they are not sufficient be-cause they don’t make explicit at which particular level the error did happen and which contextual(s) element(s) could be controlled to avoid it next time hence the need of the Contextual Graphs (CxG) formalism [8]. • The Actor Technicians (actors) at reception and registration desks constitute a highly qualified staff trained to accomplish their tasks under control of the medical staff. Non-habilitated actor (with different skills) will generate a risk of nonconformity. Even with technicians working routinely, there are risks of NC because they may rely too much on their experience and be less attentive to the task realization (e.g. emergency situation, noncompliance with instructions, trying to help another actor, etc).

Several samples may arrive simultaneously, the technician normally handles them one by one. Nevertheless, an error may occur during task execution, especially if samples have the same nature. Another risk is the mixing or confusion in examina-tions if the technician tries to deal multiple samples simultaneously.

The responsible of any action is clearly identified (signed initials, IT code) other-wise, the responsibility of the mistake cannot be allocated to a specific actor, which could affect the follow-up and the management of nonconformity. In addition, signing the request form provides written evidence and thus a trail to explore if any error oc-curs. Cultural and organizational diversity of actors also is an important element that could be considered as well as the age and experience of the technicians. • The Task The task is modeled in a workflow as a multi-step process. Each step (a component of the workflow) is a (sub) process. The different parts of the process at recep-tion/registration steps are presented in Table 1. Checking the conformity of the re-quest form is made in eight items. The technician controls them in an order or another depending on the way he prefers to do the control (and other contextual factors). A similar procedure is applied for checking the conformity of the sample.

The conformity of the move from one step to the next one also must be checked (e.g. transfer context may be incompatible with step contexts). This move may con-cern a unique technician or a transfer of tasks between technicians, and thus context switching plays an important role (contextual dimension of the task).

The nature of the task is an important contextual element like for instance decid-ing if everything is compliant to norms or not, if the conformity blocks the sample processing, choosing the medical and technical sectors, evaluating the emergency of the situation, etc. Moreover, decision-making depends on multiple factors [9]. For example, the non-respect of the (implicit) rule "What I touch, I treat" (i.e. any transfer

of work responsibility from one person to another) is a risk of error. Responsibility transfer supposes a transfer of information, an assessment of the situation to manage with all necessary details, especially with a new technician. • The Situation The actor selects a method among different ones on the basis of training and contex-tual information such as “the patient is known”, “the surgeon is waiting the answer”. Such information (and others like “it is vacation time and the team is reduced” or “the device X is busy”) is characteristic of the situation.

The simultaneous deposit of several samples may lead to errors by mixing exami-nations. The emergency of the exam and work overload generate stress, implicitly or explicitly, on actors in their actions. This stress is handled differently from one actor to another. NC is a situation requiring specific actions different from the usual pro-cess. The working context must be replaced by a specific and independent NC context for problem solving before to return to the working context. • The Local Environment The environment includes all the entities (objects, space rooms, people and events) that are external to the current task but having a potential impact on task realization [10]. The environment of interest is all that may modify the normal status of the task (e.g. software crash following an overvoltage, an intranet problem, the pot containing the sample is broken, the glove box is empty or missing), of the actor (the physician on duty having problems and thus he is unable to concentrate), of the situation (e.g. power supply failure, poor conditioning of a sample). Thus, any problem in the venti-lation or cooling systems is unfavorable, as well as personal discussions during work-ing hours. A major risk is a failure in the pneumatic system generating either delay to the reception or the possible loss of the samples. Fortunately degraded procedures are implemented for emergency situations to do not interrupt or interfere with the work.

4 Contextual-Graph Modeling of the Examination Process

Figures 2-6 represents the integration of the Table 1 of Section 2 and the contextual elements identified in Section 3. The contextual graph contains a series of activities representing the workflow components. Each activity is a contextual graph itself.

 

 Fig. 2. AP Examination processing in AP department represented as a contextualized workflow

The activity in the reception room is described by the following contextual graph.

 

   

Fig. 3. Modeling of the reception workflow

 

 Fig. 4. Conformity checking and action (Activity 110 in Figure 3)

The management of a blocking nonconformity (Activity 125 in Figure 4) is obtained by a sequence of actions (see Figure 5).

 Fig. 5. Management of a blocking nonconformity

 Fig. 6. Modeling of the registration workflow

5 Discussion on Table and Contextual Graph Representation

The table and the contextual graph are complementary tools. Establishing a contextual graph is impossible without the information collected in the table first. A contextual graph gives a unified view on relationships between actors, tasks, documents or links to a specific action, by taking into consideration the working context, adding new situations thanks to its dynamic and incremental characteristic and finally allowing the analysis. Moreover, the contextualized workflow may evolve dynamically, thanks to the incremental knowledge acquisition that enriches the contextual graph by adding a new practice as the refinement of an existing one.

From this graph we can make a tool for practice analysis at different moments. The graph will reveal the deficiency of the standard practices document, the necessity to improve the practices and quality control. In other words, a contextual graph is a way to objectify events influencing the AP examination process [11]. Therefore it can be considered as a monitoring tool on the quality of the work.

6 Perspectives

We propose a new method for quality control at both medical and technical levels. This approach aims to tackle nonconformity situations and therefore prevent a medi-cal error and an eventual prejudice. This supposes to trace the origin and the cause of the nonconformity to correct the problem and avoid it the next time. For realizing such a progress it would be wise to do regular reports on nonconformity met, and to improve the communication between the different actors internal and external to the AP Department. A contextual graph contains the practices effectively developed by doctors and technicians, and not procedures as decontextualized average over practices. It is pos-sible to follow step-by-step the real practice developed by an actor and to compare it directly to known practices included in the contextual graph in order to detect a dis-crepancy that could lead to noncompliance. Because all the paths in a contextual graph correspond to real practices developed for a task realization, a contextual graph is, by itself, a kind of “base of experiences” [9], [12].

In addition, an actor may identify a “new practice” (good or bad) and thus enrich-es the base of shared experiences. The CXG formalism provides the ability to incre-mentally add this new practice that will avoid later another technician to repeat it.

An assessment and an effective monitoring of nonconformity are possible, thanks to the installation of software that allows to track, manage, and prevent nonconformi-ty and to monitor ongoing or delayed actions or activities [9]. It provides in few clicks all the statistics we need: nonconformity source, cause, examination number and de-scription, the correlation with the day, the sample sender, the technician at the recep-tion, etc., the goal being to allow an incremental revision of the contextual graph. It is also a way to keep technicians aware of their work and let them to react immediately to correct a degrading situation.

Improving communication between actors would be possible with 2.0-collaborative tools, secure and easy to use. Complete information could then be pro-vided in a "patient record" in preset files, where the prescriber has to fill in the boxes and whose access is limited to persons involved and protected by passwords.

7 Conclusion

The Contextual-Graphs formalism relies on the fact that past contexts can be remem-bered and adapted to solve problems in the current context. The main point here is to obtain a context-based representation of practices developed by actors that is richer than the procedures and recommendations generally proposed, which always need to be adapted to the working context. We note that the engineering domain where the

domain is better understood, people try, when possible, to replace procedures by “best practices”, although only a part of the context is taken into account.

In the Contextual-Graphs representation, the organization of the practices devel-oped by all actors is structured by contextual elements. The interest of representing technicians’ practices at the AP Department is: (1) to identify risky practices, (2) to understand how a mistake has been made, (3) to train new technicians, and (4) to know how to manage nonconformity. The main finding here is that nonconformity is related to a contextual element that was left implicit or forgotten (e.g. between two examinations, a woman gets married and come the second time with a new name, and the physician does not find the results of the previous examination) or the change of instantiation of a contextual element (e.g. status of the sample, number of request arriving at the same time, number of samples per request, proceeding order, qualifica-tion of the technician that does the task).

A risk may become a prejudice because context is not considered, underestimated or among too numerous other contextual elements. Thus, the modeling of tasks and context and its interaction with data, information and knowledge are essential in order to anticipate, control and avoid possible risks. This is particularly important when the workflow consists of a sequence of interrelated actions where an error at a particular step of the process leads to a cascade of wrong events or may be identified at the final step of the sample processing.

Modeling the context of a workflow in a pathology department and the representa-tion of the different steps in a contextual graph leads to a structure of the relevant practices (actual work) instead of the official procedure (the prescribed task) in a kind of contextualized procedure more powerful than the generally proposed “best practic-es”.

The contextual graph can be designed as a tool for monitoring the quality of work, the actions, detection and correction of nonconformities. It can integrate the AP de-partment procedures and be used as a quality control and training tool for technicians and doctors. It can also be considered as a base for IT software creation and a link between IT modules or systems in medical care. Acknowledgments. This work is supported by grants from ANR TecSan for the MICO project (ANR-10-TECS-015), and we thank partners of IPAL and TRIBVN for fruitful discussions and from the TACTIC project funded bt the ASTRID program of Délégation Générale aux Armées.

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