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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>A COMPUTATIONAL INDEPENDENT MODEL FOR A MEDICAL QUALITY MANAGEMENT INFORMATION SYSTEM</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Evgeny Cherkashin</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff2">2</xref>
          <xref ref-type="aff" rid="aff3">3</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Ljubica Kazi</string-name>
          <email>ljubica.kazi@gmail.com</email>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Alexey Shigarov</string-name>
          <email>shig@icc.ru</email>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Viacheslav Paramonov</string-name>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Irkutsk Scientific Center of SB RAS</institution>
          ,
          <addr-line>134 Lermontov Street, Irkutsk, 664033</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Lermontov Street, Irkutsk</institution>
          ,
          <addr-line>664074</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff2">
          <label>2</label>
          <institution>Matrosov Institute for System Dynamics and Control Theory of SB RAS</institution>
          ,
          <addr-line>134 Lermontov Street, Irkutsk, 664033</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff3">
          <label>3</label>
          <institution>National Research Irkutsk State Technical University</institution>
          ,
          <addr-line>8</addr-line>
        </aff>
      </contrib-group>
      <abstract>
        <p>We consider problem of Quality Management System (QMS) development for Irkutsk Regional Oncological Dispancery. The system is intended to organize the process management of medical treatment according to the standard ISO 9001:2015. QMS software subsystems are synthesized as a result of a logical inference of a set of subgoals (a scenario) with a hierarchy of modules represented in the LogTalk programming language within Model Driven Architecture (MDA) paradigm. The source Computational Independent Model is represented as a set of BPMN2.0, SysML and CMMN diagrams. The models are imported and stored as ontology A-boxes on an ontology server. The models are transformed into Platform Specific Models with following source code and initial data population. Additional data for the transformation are provided from Linked Open Data compliant sources. Usage of such kind of MDA allows us to develop QMS on the abstract model level in most cases and involve domain specialist in the formal part of the development. Rengineering business processes of the medical institution should result in patient treatment quality improvement, as well as formalizing the processes, giving ideas for automation, data accumulation and processing.</p>
      </abstract>
      <kwd-group>
        <kwd>quality management systems</kwd>
        <kwd>model driven architecture</kwd>
        <kwd>logical inference</kwd>
        <kwd>linked open data</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>Introduction</title>
      <p>
        International certification is one of the activities of an organization in the improvement of the
internal business processes and the collaboration with other counterparties. The correspondence to the
ISO 9001:2015 standards for a medical institution is an evidence of its management conformity to
the highest international degree of quality (recognized in 157 countries), which is related to the used
technical equipment. Standard ISO 9001:2015 [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ] specifies requirements for a quality management
system when an organization
a) needs to demonstrate its ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements,
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
      </p>
      <p>
        All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any
organization regardless of its type or size, the products and services it provides. The introduction of the standard
into a medical institution management ensures an improvement of its performance with economic
costs remain minimized. The quality of the medical service become much higher, as well as
working, financial and psychological conditions. According to William Edwards Deming [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ], 96% of the
problems caused by faulty management system and only 4% is staff errors. Also, the main profits of
international certification for the institutions is the higher degree of credit of counterparties, namely,
patients. The certification results in
– formal quality recognition in Russia and other countries;
– better positions in tenders;
– better positions within competitors;
– preferences by foreigners working in Russia to cooperate with international level organizations;
– being a part of the club of cooperating institutions with preferences;
– a formal statement of conformation to the sectoral standards;
– analysis of the structure of the institution, better understanding its objectives and process.
      </p>
      <p>Internal business processes of certified institution conforms to a general scheme depicted in Fig. 1.</p>
      <p>Organizational
environment
(contractor,
consumer, etc.)
contentment
requirements</p>
      <p>Continuous quality management
improvement</p>
      <p>Management
responsibility
Measurement,</p>
      <p>analysys,
improvement</p>
      <p>Resource
management
Input
Output</p>
      <p>Product
realization</p>
      <p>Product</p>
      <p>Standard ISO 9001 considers each business process (BP) in a set of aspects. A BP realizes a
product according to requirements stated by counterparties or organizational environment. The result of
the production and customers’ contentment are measured and analyzed forming improvement
recommendations for management staff. Management staff works out decisions on resource management
and BP improvement, accounting customers’ recommendations.</p>
      <p>ISO 9001 QMS implements practical approach of multistep process structure reconfiguration,
locally and sequentially improving it in a subsystem. The basis of a decision forming is analysis of
customer needs solved by a product and its quality criteria. These are named as counterparties
expectations. The management stuff determines unities of purpose and direction of the organization
functioning and raises the engagement of people, aligning people’s and organization’s needs. Since a
model of the production is represented as a system of process, it allows managers in changing
condition to maintain the functionality and improve the system locally and in several independent parts
simultaneously to generate various new opportunities. The improvement is based on decisions, which,
in turn, are based on evidences, e.g. measurements. The outer aspect of the organization sustainable
functioning is expressed with relationship management within resource approach. These terms are the
reference points for information system supporting the rengineering of the organizational structure.</p>
      <p>As of today the organizing structure of Irkutsk Regional Oncological Dispancery (IROD) is
described as a set of documents presenting the business processes as hierarchy structures of the BP and,
in parallel, a block diagrams of algorithmic schemes of the process element relations in time. This
approach corresponds the present modeling technologies taught to students of management occupations
in Irkutsk universities. The approach ought to be improved with more expressive but complex
notions of SysML (System Markup Language), BPMN–2.0 (Business Process Modeling Notation) and
CMMN (Case Management Modeling Notation). SysML used to describe organizational structures in
higher degree of abstraction with respect to UML2 and in the same time to be more detailed. The usage
of these modeling notation will allow to describe the organizational structure of IROD more formally
and precisely as a Computational Independent Model of MDA paradigm.</p>
      <p>
        Heaving described BPs structure and flows of IROD in the formal detailed multilevel form in
SysML, we could construct an environment of a permanent Informational System (IS) research and
development. At the first stage, a most simple case is being realized: the description could be
converted into check lists controlling conditions of business process starting and ending points, e.g., check
whether all the manipulation and medicines were applied to a patient before surgery. The second stage
of implementation is the automation of the patient medical care planning after the surgery. The third
stage is to organize a CRM subsystem for patients, e.g. arranging appointments at medical office and
proceed with a medical care. In the long run a refined SysML description and the IS would include
integration with Laboratory IS installed at the hospital. All the stages are accompanied with a lot of
useful information to be accumulated, forming the quality measurement and analysis basis [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ].
      </p>
      <p>The object of the research is to develop generative technology of expression of process structure
of a medical institution in abovementioned notations (SysML, BPMN-2.0, CMMN) and conversions
of the description into subsystems of a complex information system supporting the BP reingeneering
processes. The subject we consider in this paper is to describe tools and techniques of their applications
in the technologies as being represented within MDA.
2</p>
    </sec>
    <sec id="sec-2">
      <title>Architecture of MDA tools</title>
      <p>The architecture of the software development tools is based on the provision of uniformity of the
transformation rules language and predicate input data representation. That’s why we require to store
all the input model data in Semantic Web graphs of ontologies. The ontologies could be served as
RDF–files of triples or with servers having SPARQL endpoints. A general architecture of the
development tools is presented in Fig. 2.</p>
      <p>
        The kernel of the system is MDA Tool, which is a set of transformational modules (T–Modules).
Each of T–Module in a general case is a parameterized LogTalk object. The object queries the Server
of domain models, which is built on the base of Cliopatria [
        <xref ref-type="bibr" rid="ref4">4</xref>
        ], other objects and other Ontology servers
for structural patterns. These patterns are analyzed and the results are stored as the objects states,
i.e. cached. The states of the object represent Platform Specific Model (PSM), which is translated
into source code and initial data. Input structures of CIM and PIM models are converted into graphs
with converter adapters. For example in Fig. 2 CIM drawn in Modelio [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ] is converted to triples with
Inference
machine
      </p>
      <p>DB
XMI to RDF
converter
XMI
presenta on of
a PIM</p>
      <p>CIM</p>
      <p>XMI to RDF
converter</p>
      <p>SysML Editor
(Modelio)
XMI
presenta on of
a CIM
T-Module</p>
      <p>T-Module
Generated
source code
and data
MDA Tool
Ontology</p>
      <p>T-Box
DB</p>
      <p>T-Module
SPARQL
endpoint</p>
      <p>DB adapter
Ontology server (e.g. DBPedia.org)</p>
      <p>Pengines
SPARQL
endpoint
UML Editor
(Modelio)
Server of domain models</p>
      <p>PIM
a special module “XMI to RDF converter”. Similar converter is realized for PIM represented in UML.
This approach makes the input stage modular, and, consequently, easier extensible with new models.</p>
      <p>Another important source of information for the synthesizer is ontologies describing various
abstract and concrete special domains. The Semantic Web technologies, namely Linked Open Data,
allow us to infer the properties of generated structural elements. User interface visual element attributes
(a part of PSM) can be partially figured out by means of SPARQL queries to DBPedia.org, which
contains naming of entities in various languages, as well as other useful relationships. For example,
we can use DBPedia for constructing title and placeholder attributes of an input widget, together
with its label in user’s locale and a help description.
3</p>
    </sec>
    <sec id="sec-3">
      <title>Related work: SysML usage in system design and synthesis</title>
      <p>
        SysML is the dedicated system-level UML-based notation proposed by the OMG. In research [
        <xref ref-type="bibr" rid="ref6">6</xref>
        ]
system design productivity is addressed as one of the main challenges. Some suggested approaches are
increasing the level of abstraction and automation, as well as producing executable specifications. In
[
        <xref ref-type="bibr" rid="ref7">7</xref>
        ], model driven development is used for the construction of complex embedded systems integrating
software and firmware. A SysML system model is devised according to the platform-based design
paradigm, in which a functional model of the system is paired to a model of the execution platform.
Subsystems are refined as Simulink models or hand-coded in C++.
      </p>
      <p>
        The SysML standard is attracting more attention of hardware designers as UML and SysML have
been used to automatically generate an HDL code written in SystemC, Verilog and VHDL. In [
        <xref ref-type="bibr" rid="ref8">8</xref>
        ],
contrarily to the existing works, authors propose the new reverse engineering approach to generate
SysML definition of block and internal block diagrams from VHDL code. Code generation is done on
the basis of a set of well-defined mapping rules between SysML and VHDL concepts.
      </p>
      <p>
        UML profiles like SysML and MARTE have been a major research topic in electronic system
design, but are mainly applied for specification and analysis in early design phases. Research [
        <xref ref-type="bibr" rid="ref9">9</xref>
        ]
addresses the problem of the High-Level Synthesis (HLS), i.e. physical implementation aspect of
electronic systems, which need diversity of design models and levels of abstraction. To overcome the
conflict between a higher degree of abstraction and necessary details for further synthesis, modular
interfaces are introduced as object-oriented synthesizable technique. In [
        <xref ref-type="bibr" rid="ref9">9</xref>
        ], SysML is used as an
adequate modeling language for modular interfaces and C/C++/SystemC-based HLS. Authors extended
SysML with annotations for synthesizable SystemC and high-level synthesis constraints and
implemented a code generation scheme to achieve design flow automation. They used SysML editor Artisan
Studio with industrial case study to demonstrate the applicability of SysML as a front-end for HLS.
      </p>
      <p>
        In [
        <xref ref-type="bibr" rid="ref10">10</xref>
        ] UML/SysML is used to model avionics. The implementation language is C# with using
libXML for XMI import and processing. Generated objects represent each syntactic element (struct,
enum, function, etc.), which represents the target source code. Authors implemented only State
Machine diagram transformation.
      </p>
      <p>Some experience of representing document flows are obtained by commercial software vendors
developing Directum, Documentum systems automatizing Russian municipal institutions and state
corporations. Directum uses SysML state–like block diagrams to define flow of documents and the
ISBL object-oriented language to express sophisticated behavior.</p>
      <p>In our research we focus on representation of ISO 9001 entities in SysML and other DSLs
translatable to RDF, and the MDA transformation logical inference representable as LogTalk objects.
4</p>
    </sec>
    <sec id="sec-4">
      <title>SysML representation of QMS</title>
      <p>
        QMS is represented in SysML with nine diagrams [
        <xref ref-type="bibr" rid="ref11">11</xref>
        ]. QMS requirements is represented with new
(with respect to UML) Requirement Diagram, describing stated structural and logical constraints.
Structural aspects are represented with following UML2 diagrams:
– Block Definition Diagram decomposes structure of activities, attributes and objects on elements;
– Internal Block Diagram models interaction of the decomposed elements and their data flow; its
descendant new Parametric Diagram describes model of block attribute relationships;
– Package Diagram organizes models in packages in various ways.
      </p>
      <p>Behavioral aspect of a QMS is expressed with UML2
– Use Case Diagram, which expresses functions of the system and their mutual relationships;
– State Machine Diagram defines the states of the blocks and transitions between the states;
– Sequence Diagram describes the order of messages between blocks and actors;
– Activity Diagram represents computational process of converting data enclosed in blocks.</p>
      <p>BPMN2.0 diagram is used to describe imperative procedures, it is very expressive diagram
representing functions and involving agents, together with their relationships. CMMN represents
declarative aspects of the QMS especially data structures, processing stages, events and check points
(milestones). Adding BPMN2.0 and CMMN diagrams to SysML diagram set creates a redundancy, but in
the same time it allows one to use more rich tool set for QMS modeling.
5</p>
    </sec>
    <sec id="sec-5">
      <title>Defining rules of transformation</title>
      <p>
        Transformation process is organized as a scenario of connected transformational objects (in terms
of LogTalk) [
        <xref ref-type="bibr" rid="ref12">12</xref>
        ]. Scenario is programmed as a special object defining transformation by means of
calling tr/N rules. Rules recognize structures in the input graph elements and constructs code blocks.
:- object(direct(_Package,_LocalProf,_CodeProf)). Attributes::append(Attribute) ),
:- public([tr/4,tr/3]). forall(
:- protected([package/1, profiles/2, profile/1]). ::tr(method, Method, ClassID, _MethodID),
package(Package):- parameter(1, Package). Methods::append(Method) ),
profile(Profile):- parameter(2, Profile). Class::attributes(Attributes),
profile(Profile):- parameter(3, Profile). Class::methods(Methods).
profiles(L):- tr(attribute, Attribute, ClassID,
AttributeID):findall(Profile, ::profile(Profile), L). ::package(Package),
tr(class, Class, ClassID):- ::package(Package), query(Package)::attribute(Name,ClassID,AttrID),
query(Package)::class(Name, ClassID), create_object(Attribute,
create_object(Class, [instantiates(param)],[],[]),
[instantiates(class)],[],[]), Attribute::name(Name).
create_object(Attributes, tr(method, Method, ClassID,
MethodID):[instantiates(params)],[],[]), ::package(Package),
create_object(Methods, query(Package)::method(Name,ClassID,MethodID),
[instantiates(methodlist)],[],[]), create_object(Method,
Class::name(Name), [instantiates(method)],[],[]),
forall( Method::name(Name).
      </p>
      <p>::tr(attribute,Attribute,ClassID,_AttrID), :- end_object.</p>
      <p>The previous listing uses static parameterized object query/1, whose argument is a graph
representing model under transformation. This is a powerful LogTalk abstraction instrument, which reduces
necessity of adapter object creation in dynamic memory. The SPARQL is encapsulated in methods.
:- object(query(_XMI)).
:- protected(xmi/1).
:- public([class/2, attribute/3, method/3]).
xmi(XMI) :- parameter(1, XMI).
class(Name, ID):- ::xmi(XMI),</p>
      <p>XMI::rdf(ID,rdf:type,uml,'Class'),</p>
      <p>XMI::rdf(ID,rdfs:label, literal(Name)).
attribute(Name, ClassID, ID):- ::xmi(XMI),</p>
      <p>XMI::graph(G),
XMI::rdf(ClassID, G:ownedAttribute, ID),
% XMI::rdf(ID, rdf:type, uml,'Property'),</p>
      <p>XMI::rdf(ID, rdfs:label, literal(Name)).
method(Name, ClassID, ID):- ::xmi(XMI),</p>
      <p>XMI::graph(G),
XMI::rdf(ClassID, G:ownedOperation, ID),</p>
      <p>XMI::rdf(ID, rdfs:label, literal(Name)).</p>
      <p>:- end_object.</p>
      <p>Procedure of source code generation is build using code_block–objects (the idea was taken from
llvmlite library), which provide PSM representation:
:- object(code_block, specializes(root)).
:- public([append/1, prepend/1, clear/0,
render/1, render_to/1, remove/1, item/1,
items/1 ]).
:- dynamic([item_/1]). % elements of
:- private([item_/1]). % the code block
:- protected([renderitem/2, render_to/2]).
item(Item) :- ::item_(Item).
items(Items) :- bagof(I, ::item(I), Items).
append(Item) :- ::assertz(item_(Item)).
prepend(Item):- ::asserta(item_(Item)).
remove(Item) :- ::retract(item_(Item)).
clear :- ::retractall(item_(_)).
render(_) :- writef::writef("ERROR: \
Implement render/1 by a subclass!\n"), fail.
render_to(Stream):- ::render(List),</p>
      <p>::render_to(List, Stream).
render_to(List,
Stream):lists::is_list(List),!,
forall(lists::member(X,List),</p>
      <p>::render_to(X, Stream)).
render_to(X,_) :- write(X),nl.
renderitem(Object,
String):current_object(Object), !,</p>
      <p>Object::render(String).
renderitem(literal(Item), String):-!,</p>
      <p>atom_string(Item, String).
renderitem(Item,
String):</p>
      <p>root::iswritef(String, '%q', [Item]).</p>
      <p>:- end_object.</p>
      <p>The code_block–objects consist of source code string lines and other objects, including other
code blocks. Each item is denoted with item/1 and its private database element item_/1. The type of
the element is defined by outer functor of the argument, e.g., we define with attributes(L) a list L
of attributes of a class. The way of rendering the sources is implemented by subclassing the object and
realizing render/1 and renderitem/2. The first argument of renderitem/2 is the item/1–structure
to be rendered, and the second one is the list of strings representing generated source code. Elements
of the code block can be appended, prepended and removeed. We specially disallow to insert items
into the database, as it will make object and its database more complex. Instead, programmer can add
an item being another code block, inserting elements of the sources in it.</p>
      <p>The following example shows rendering class for Python classes. It contains public methods for
defining class elements.
:- object(class, specializes(code_block),</p>
      <p>imports([named])). % A category of named entities
:- public([classlist/1, methods/1, attributes/1]).
classlist(ClassList):- % List of base classes</p>
      <p>::prepend(classlist(ClassList)).
attributes(Attributes):- % List of attributes</p>
      <p>::prepend(attributes(Attributes)).
methods(MethodList):- % List of methods</p>
      <p>::append(methods(MethodList)).
renderitem(Item, Result):- % Default</p>
      <p>^^renderitem(Item, Result).
render(Result):- % Render the class
^^render(Name),
( ::item(classlist(List)) -&gt;</p>
      <p>List::render(ClassList),
root::iswritef(Signature,'class %w(%w):',</p>
      <p>[Name, ClassList]);
root::iswritef(Signature,'class %w:',</p>
      <p>[Name]) ),
root::indent, % add an indent
( ::item(attributes(Attributes))-&gt;</p>
      <p>Attributes::render(DefAttrList),
root::iswritef(ConstructorDef,
'def __init__(self, %w):',
[DefAttrList]),
root::indent, % more indent
Attributes::items(InstanceAttrs),
findall(S, ( % initialize attributes
lists::member(Attr, InstanceAttrs),
Attr::item(name(AttrName)),
root::iswritef(S, "self.%w=%w",</p>
      <p>[AttrName, AttrName])
), AttrAssigns),
root::unindent,
AttrList=[ConstructorDef|AttrAssigns];
root::iswritef(ConstructorDef,</p>
      <p>'def __init__(self): ', []),
root::indent,
root::iswritef(Pass,'pass', []),
root::unindent,</p>
      <p>AttrList=[ConstructorDef, Pass] ),
( ::item(methods(Methods))-&gt; % if any ...</p>
      <p>Methods::render(MethodList);</p>
      <p>MethodList=[] ),
lists::append(AttrList,MethodList,StringList),
root::unindent, Result=[Signature|StringList].</p>
      <p>:- end_object.</p>
      <p>In the same way, we can construct procedures for creating structures of databases and populating
them with initial data.
6</p>
    </sec>
    <sec id="sec-6">
      <title>Conclusion</title>
      <p>The idea of formal description of the business process during transition of a medical institution
for compliance to ISO 9001:2015 standard is considered in the paper. Diagrams SysML, BPMN2.0,
CMMN are proposed to be used for this purpose. The description provides Computational Independent
Model (CIM) of Model Driven Architecture (MDA) software development approach, and it is to be
transformed in subsystems of Informational System (IS).</p>
      <p>
        CIM is being designed with visual editors, e.g. Modelio [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ], translated from their XMI to RDF and
stored as ontology graphs as files or network resources. MDA-transformation is represented and
executed within Prolog programming environment LogTalk [
        <xref ref-type="bibr" rid="ref12">12</xref>
        ], which provides us knowledge
structuring, rich set of libraries and uniform well-known programming language for defining transformation
rules. The general scheme of transformation definition is presented.
      </p>
      <p>
        IS development tools is being tested in representation of bioinformatic tool Mothur as Rapidminer
dataflow diagrams [
        <xref ref-type="bibr" rid="ref13">13</xref>
        ]. The source data for transformation is the module specifications and UML
Class Diagram, which organizes submodules in virtual class hierarchies.
7
      </p>
    </sec>
    <sec id="sec-7">
      <title>Acknowledgments</title>
      <p>The results are obtained with the partial support of the various projects: Irkutsk scientific center of
SB RAS No 4.2; Russian Foundation for Basic Research, grants 17-07-01341, 18-07-00758 and
1747-380007. The results obtained with the use of the network infrastructure of Telecommunication
center of collective use “Integrated information-computational network of Irkutsk scientific-educational
complex” (http://net.icc.ru).</p>
    </sec>
  </body>
  <back>
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