ICT TO IMPROVE SAFETY, TRACEABILITY AND

RELIABILITY OF CLINICAL PROCESSES WITH

QUALITY ASSURANCE ISSUES

The Case of Stem Cells

Vittorio Montefusco

, Elena Sini

, Michele Torresani

, Paolo Locatelli

Nicola Restifo

and Roberta Facchini

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milano, Italy

Fondazione Politecnico di Milano, Via Durando 38/A, 20158, Milano, Italy

Keywords: AIDC technology, Mobile&wireless, RFId, Business process reengineering, Process traceability, Stem cells,

Therapy management, Process quality assurance, Transfusion safety.

Abstract: Traceability and quality assurance of bedside processes are often still manual, without the appropriate

support of information systems. Automatic Identification and Data Capture (AIDC) solutions integrated

with Mobile&Wireless devices are key solutions to meet the needs of secure identification of persons and

items and of traceability of processes in healthcare organizations. These technologies can fit a variety of

processes, like enterprise-wide person/item identification, blood transfusions, surgical samples

identification, therapy management. The challenge is to extend the use of these solutions also to other

processes like biobanking, where stem cellular products require strict procedures of collection and

manipulation, even in critical environmental conditions. Fondazione IRCCS Istituto Nazionale dei Tumori

in Milan (Italy) has a wide experience in RFId projects and is starting to lead a project aimed to design,

develop and implement a set of organizational models, acknowledged procedures and ICT tools in order to

improve actual support to collection and transplantation of Human Stem Cells. In this paper we present a

literature overview of cases of implementation of AIDC technology solution and of how its character of

ubiquity and versatility could fit well with process requirements, discussing the Istituto’s business case.

1 INTRODUCTION

The volume and the complexity of clinical and

administrative information make Information and

communication Technologies (ICTs) essential for

both running and innovating healthcare

organizations.

In this paper we want to focus on the use of ICTs

to face lack of process monitoring information in

healthcare, above all as regards identification, safety,

quality assurance.

2 CRITICALITIES IN CLINICAL

PROCESS MANAGEMENT

The process of patient care may be a complex and

composite sequence of visit, examination, treatment

and so on. To attend the patient in a path of care

means to deal with both staff workflow activities

and direct contact with patients. Common literature

states that most of the threats to patient safety are

process-related, rather than clinical. Referring to a

literature review conducted specifically in oncology

by Schwappach and Wernli in 2010, for example,

medication errors seem to be distributed among:

41% in nurse administration (predominantly omitted

medications and wrong doses), 38% in medication

dispensing (predominantly nursing dispensing errors

such as incorrect dose or wrong medications), and

21% in order writing or transcription (predominantly

pharmacy errors). In general, processes are

characterized by inefficiency related to

organizational and procedural issues: there are

difficulties in timely accessing patient information; a

305

Montefusco V., Sini E., Torresani M., Locatelli P., Restifo N. and Facchini R..

ICT TO IMPROVE SAFETY, TRACEABILITY AND RELIABILITY OF CLINICAL PROCESSES WITH QUALITY ASSURANCE ISSUES - The Case of

Stem Cells.

DOI: 10.5220/0003875003050311

In Proceedings of the International Conference on Health Informatics (HEALTHINF-2012), pages 305-311

ISBN: 978-989-8425-88-1

 2012 SCITEPRESS (Science and Technology Publications, Lda.)

high number of actors involved in the process (e.g.

chemotherapy) makes it difficult to ensure

traceability of activities and completeness of

information; procedures are different in each ward

and also documents may differ between

departments; there is limited knowledge and

expertise sharing between professionals involved in

the same process and taking care of the same

patients. This reflects the actual situation in many

organizations, where especially bedside activities are

still manually managed, without the appropriate

support of information systems. This is crucial in

terms of patient safety. In this context the challenges

to be faced to ensure quality and safety to the

clinical process are:

- To ensure reliable patient identification

throughout all processes during his/her stay in the

healthcare organization;

- To enable process traceability, allowing clinical

staff to record activities performed both in “back

office” and involving directly the patient, increasing

the amount and the quality of stored data;

- To support clinical staff in performing activities

depending on the quality and the amount of

available data about the patient. The fewer available

data, the less decision making support for staff;

- To improve governance and cost control,

reducing inefficiencies in information sharing and

communication between practitioners involved in

same workflow.

3 AIDC TECHNOLOGIES AND

CLINICAL PROCESS

In the scenario described above ICTs become

essential for support and governance, deeply

affecting the management of information flows,

allowing to extend and strengthen the capability to

of very different kinds and uses. A key issue in this

effort is to reduce errors and enhance efficiency by

supporting process traceability and safe

identification of patients and items.

Automatic Identification and Data Capture

(AIDC) identifies tools for the identification and/or

direct collection of data into a computer system,

programmable logic controller (PLC), or other

microprocessor-controlled device without using a

keyboard. Many technologies that can be involved in

AIDC solution are: Bar Code and Card

Technologies, Radio Frequency Identification

(RFId), Real Time Locating Systems, etc. The most

important application areas of AIDC technology in

the healthcare sector are: identification and/or

geolocation of people or objects, operations support,

process tracking and logistics. This because

solutions based on AIDC technologies (like RFId)

can be used to ensure fast and unambiguous

identification of items and patients within the

organization, as well as they enable local storage and

update of data during activities. The same

technology can be used also for asset location and

management of maintenance activities. Another high

potential field includes applications implementing

combined identification of people and items, thus

enabling a patient-to-object cross-match.

Another relevant group of IT solutions available

and valuable for healthcare process management are

Mobile&Wireless technologies (e.g. PDAs, MCAs,

…), which enable mobile access to clinical

applications also at patient bedside, continuous

monitoring patients’ conditions, ubiquous

registration and access to clinical data when needed.

When integrated, these two innovative

technology families can provide staff with solutions

both to support care processes and to monitor them.

A survey issued in 2010 by the ICT in Health Care

Observatory of the School of Management of the

Politecnico di Milano shows that Italian CIOs are

rating Mobile&Wireless and AIDC technologies as

important to increase Electronic Patient Record

(EPR) functionalities, increasing their effectiveness

and thus care safety. Indeed Mobile&Wireless

solutions, integrated both to AIDC technology

solutions and to the Hospital Information System

(HIS), enable to close the patient safety loop

bringing EPR access to clinicians directly at bedside.

In literature we can find many organizations

having started AIDC technologies implementation

projects, in order to assure internal identification and

tracking procedures, but until now the health-care

industry has not invested systematically in

information technology and many processes still rely

on paper record-keeping and individual memory.

Summing up, literature classification models for

AIDC technology solutions distinguish between:

Patient and/or staff identification and tracking, Asset

management and tracking, Clinical process

traceability (blood, specimen and drug

management), Management of surgical instruments,

Inventory management and drug counterfeiting,

Patient documentation management and automatic

biological parameters capture.

As regards asset management, Emory

Healthcare, Georgia's largest health-care system, has

deployed an RFId-based asset-tracking system to

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improve management and utilization of infusion

pumps and other high-value equipment. Here, RFId

readers installed at doorways record when pumps

enter or leave utility rooms. Location sensors are

also installed at the entrance and exit points of the

inventory areas, providing an inventory of tagged

pumps available for use.

Other operations support systems, coming from

manufacturing practice, are e.g. sample tagging for

automatic processing in the laboratory, item tagging

for blood bank or pharma cabinets control both in

the replenishment and in the picking phase, systems

for automated issue of medicine doses. For example

the Masaryk Memorial Cancer Institute in the Czech

Republic is using RFId to track vials of expensive

chemotherapy medications, in an effort to better

manage the potentially dangerous process of mixing

the medication with infusion solution. Working in

chemo-hoods, technicians take an RFId-tagged bag

and fill it with the proper amount of drug. Patient's

name and other basic information are electronically

written on the label. The pharmacist wears a ring-

shaped tag on one finger and after mixing the

medication with the solution, he matches the tags on

the bag, on the drug vial, and on his ring and, using a

reader installed inside the chemo-hood. The bag is

then removed from the chemo-hood, and another

check is done when passing the output hatch. The

information collected via RFId allows the hospital to

track when, what, by whom, and how the specific

medication was prepared.

Similar systems can also be used for process

optimization, by monitoring real-time patient ﬂows

(and thus possible bottlenecks) in First Aid Wards or

in Radiology Departments. Success examples are the

St.Vincent’s Hospital in Birmingham (UK) or

Fondazione Macchi di Varese (Italy).

But most important implementations of AIDC

technologies are for bedside support to clinical staff.

This can be done by applying bracelets to patients at

admission, and identifying all items related to a

patient (e.g. patient records face sheets, vials,

receipts, blood bags, drugs) by means of labels.

AIDC solutions can be used for example to control

drug administration, in the operating theatre and in

the transfusion area for patient-to-treatment

verification. An interesting case of study is Boston

Beth Israel Deaconess Neonatal Intensive Care Unit

(NICU), where babies are identified with RFId

wristbands. Mothers’ milk is tagged upon storage in

refrigerators and when a nurse has to feed a baby,

she first scans the milk, then the baby. A software

application ensures that the right infant receives the

right milk and automatically creates an audit trail.

Additionally, RFId scanners are fixed at door frames

to detect babies carried in and out the NICU.

Another example of this kind of applications is at the

Wisconsin Blood Centre, where tags on donation

bags are written with information on time, blood

type, identification number, and expiration date. The

center processes the blood, and when a bag of

processed blood leaves a blood center en route to a

hospital, its tag is read in order to register that bag's

departure, and the time and date of that activity.

When a hospital receives the blood bag, it utilizes a

separate section of the chip's memory to register data

on the recipient patient. When blood is administered

to the patient, the bag tag will be read again, thus

confirming that the patient is receiving the proper

unit. Thus, the systems supports on one side

shipment traceability from the Blood Centre to

patients in other hospitals, on the other side it

supports transfusion safety directly at bedside.

These few examples show how AIDC may help

healthcare workers by enabling to automatically

identify assets and patients, to track inventories, to

control accesses, to enhance equipment utilization,

to optimize staff time and to improve patient safety.

In addition, traceability data can be used to improve

business processes, from optimization of process

bottlenecks to planning of equipment maintenance.

The potential value of such technologies to

healthcare processes can vary within a wide range of

solutions and is applicable to a variety of processes,

including pharmacotherapy, chemotherapy, blood

transfusions, radiotherapy, medications, surgical

activities and so on.

4 HAEMATOPOYETIC STEM

CELLS TRANSPLANTATION

PROCESS NEEDS

Human Stem Cells (HSCs) transplantation is a life

saving therapy in the treatment of several congenital

or acquired hematologic disorders (e.g. a timely

implantation is key for patient recovery after

chemotherapy treatments). The Transfusion Service

(SIMT) collects stem cells in order to satisfy

transfusion and transplantation clinical needs. There

are two kinds of transplantation procedures:

allogenic (between family members or genetically

distinct individuals) and autologous (patient self-

donation).

Human cellular products (HSCs and Therapeutic

Cells-TCs) are transplantable products which require

strict procedures of collection, preservation and

ICT TO IMPROVE SAFETY, TRACEABILITY AND RELIABILITY OF CLINICAL PROCESSES WITH QUALITY

ASSURANCE ISSUES - The Case of Stem Cells

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administration in order to guarantee patient safety

and exhaustive documentation in each phase of the

process. In particular, blood transfusion and HSC

management have common needs of validated

standard procedures, effective organization models

and state-of-art ICT tools in compliance with

international standards FACT-JACIE (Joint

Accreditation Committee of ISCT-EBMT -

International Standards for Cellular Therapy Product

Collection, Processing, and Administration). Clinical

studies state how clinical outcome of cell therapy is

on average better in centres implementing FACT-

JACIE standards.

HSCs and TCs management typically involves

three actors: (i) the Transfusion Service manages

donors selection and cell collection or receiveing

from external biobanks; (ii) the Stem Cell Lab

processes, fractionates, and cryopreserves collected

units and delivers the bags for transplantation to (iii)

the Clinical Units. The most relevant steps are donor

acceptance (new or known person), blood sampling,

units labelling and processing before

cryopreservation. Very important issues of this part

of the process are donor identification and items

labelling, particularly critical phases both for

legislative and operational aspects (some possible

adverse events can be generated here).

Italian healthcare providers implement a variety

of organizational models (e.g. outsourced activities,

duties of each unit,..), supporting tools, working

procedures. Moreover, despite FACT-JACIE

qualification of centres is strongly recommended by

the Italian Ministry of Health, there is still a need for

greater efficiency in the management of the

transplantation process, as there are no standard and

validated information systems for detailed

monitoring and control of the process, neither in the

wards, nor in the Stem Cell Lab.

Some examples follow. The Transfusion Service

does not have full awareness of laboratory

processing activities and actual stocks (e.g. units

collected by the Transfusion Service get fractioned

by the Lab, but no trace is on the Transfusion

Service management system). In the lab, staff can

calculate their stock mainly by manual checks of

donors history sheets, where all information on

donated bags is registered: such a procedure does

not support an efficient management of such data.

Also bedside activities show some critical issues,

many similar to those in the transfusion process:

unambiguous patient identification, bags and vials

labelling, in the ward safe cross-matching, adverse

reaction notification, process monitoring and

traceability. The Transfusion Service often relies on

notes about performed implantations to update

patients’ transfusion record on the Blood Bank

Management software or register.

Another common aspect regards self-donation

for autologous transplantation: this particular

procedure requires to be managed in order to collect,

identify and trace for long periods of time huge

stocks of cells collected and reserved for the donor

patient. This is a very critical secondary flow which

has to be supported carefully because of potential

risks for patients in not correct identification (e.g.

mismatch between fractionated units due to different

identifiers used by the Lab and the Transfusion

Service) or mistakes between patients.

A preliminary inquiry on actual critical points in

process configuration can be summarized in some

key topics:

Absence of fast, safe and unambiguous

identification system for patients, sample tubes and

stem cell bags;

Complexity of clinical datasets on units and

patients;

Process fragmentation between different units

with different duties, low communication and poor

information record;

Paperwork and manual activities scarcely

supported by existing IT systems, which are often

just lists on files.

This is even more significant if we consider that

product quality is given for granted by the mutual

assumption made by staff, that each process step was

performed by colleagues according to established

procedures. These considerations highlight the need

of a coherent and integrated approach to innovation

through the analysis, design and introduction of

organizational models and state-of-the-art ICT

solutions to link actors and enable a safer

management of bags and clinical information on

transplantation. This is particularly challenging as it

regards process revision and technology-related

issues, because of the frailty of stem cells, of the

particular environmental conditions (e.g. deep freeze

long term storage), of the number of different

departments involved in the chain of activities.

Nevertheless, we believe that, despite many

additional challenges, the main features of ubiquity

and versatility of AIDC and M&W technology fit

stem cells process management needs, and can

improve quality, safety and efficiency.

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5 AIDC TECHNOLOGIES AT

ISTITUTO NAZIONALE DEI

TUMORI DI MILANO

Founded in 1925, Fondazione IRCCS Istituto

Nazionale dei Tumori in Milan (Italy) is recognized

as a top Scientific Research and Treatment

Institution in Oncology. In 2010, over 210 research

projects were under way and nearly 426 scientific

papers were published (IF 2274.38). Istituto cared

for about 13,700 inpatients (482 accounted by the

Regional Government), 9,600 day-hospital

admissions, 1.1 million outpatient treatments, 11,500

surgical operations. It also inspired the Lombardy

Oncology Pathology Network (ROL).

Given high needs of process reengineering and

more efficient information management, in recent

years organizational and technological changes have

been implemented, aiming at digitalizing processes

and incrementing traceability. The Istituto

collaborates with partner Fondazione Politecnico di

Milano, a research institution connected to the

Technical University in Milan with expertise both on

clinical process management and on technological

aspects. Also in this case, Fondazione supports the

implementation of project according to

methodological frameworks like the Business

Process Reengineering, to address the introduction

of innovative ICT solutions with integrated action on

three key levers: processes, organizations and skills,

technology. At the same time, internal workgroups

involving known experts analyse a variety of issues

related to clinical risk management.

Aiming at completing the ICT support to clinical

processes, the Istituto has been adopting innovative

solutions integrated to the HIS in order to avoid

errors and enhance patient safety and quality of care.

The use of mobile devices is gradually spreading

within wards thanks to the development and

evolution of the Istituto’s enterprise RFId platform

for traceability and safe identification in clinical

processes. The Istituto’s Mobile &Wireless strategy

aims at building an ICT infrastructure (hardware and

software integrated to the involved HIS modules)

which guarantees secure identification of patients,

staff, treatments, and critical items in crucial

checkpoints within the clinical pathway. Nowdays,

the Istituto’s RFId platform supports traceability and

safety needs within a growing number of clinical

activities, from general patient identification (access

to the operating room, access to radiotherapy

rooms,..) to patient-to-treatment crossmatching

(blood bags, sample tubes, surgical sampling,..).

This is done through several different WiFi devices

like handheld readers attached to standard desktop

PCs or smart PDAs with a thematic workflow

management application installed (e.g. the

transfusion safety app, the bedside radiology app,

and so on). The Istituto is also carrying on a project

about pharmacotherapy digitalization and

chemotherapy management, where also RFId

technology will be used to track drugs manufactured

in a centralized lab, sent to wards, and then

administered to patients (as regards chemotherapy,

the Istituto is leading a Strategic Program funded by

Italian Ministry of Health involving over 20 Italian

healthcare organizations to define a complete

competence framework and an integrated solution

for patient safety, process quality and overall

efficiency improvement).

6 THE CASE: EXTENDING THE

ISTITUTO’S RFID PLATFORM

TO STEM CELL MANAGMENT

Recognizing this expertise, the Regional

Government of Lombardy and the Italian Ministry of

Health have funded a research project lead by dr.

Vittorio Montefusco, a physician working at the

Istituto’s Haematology and Bone Marrow

Transplantation Unit (whose chief executive is the

renowned oncologist dr. Paolo Corradini).

The goal is to design, develop and implement a

set of organizational models, acknowledged

procedures and ICT tools in order to improve actual

support, safety, reliability and traceability in

haematopoietic stem cells (HTCs) and therapeutic

cells (TCs), in full compliance to the internationally

recognized FACT-JACIE standards. This will allow

clinicians to guarantee and trace high quality

standards in procedures and data handling, also

providing more accurate traceability data on stem

cell collection and implantation (e.g. process lead

times, haemovigilance).

A.O. Ospedale “Ca'Granda" Niguarda in Milan

(which is the largest public hospital in Milan),

Fondazione IRCCS Istituto Neurologico "Carlo

Besta" (a research and care institute for neurological

pathologies), and Fondazione Politecnico di Milano

are involved in the project, each one bringing

specific support needs. In fact, the Istituto and

Niguarda run important storage and transplantation

facilities, and Besta and Istituto are more focused on

research activities even if respectively on oncology

and neurology.

ICT TO IMPROVE SAFETY, TRACEABILITY AND RELIABILITY OF CLINICAL PROCESSES WITH QUALITY

ASSURANCE ISSUES - The Case of Stem Cells

309

The idea is to extend the Istituto’s RFId

traceability platform in the field of HSC and TC

process management, supporting the whole process:

from cell donation, fractioning, lab processing, long-

term cryopreservation, delivery of the bag and

transplantation to receiver patient in clinical units (or

extraction for research purposes). The designed

solution will provide the Transfusion Service and the

Stem Cell Lab specific tools for up-to-date

traceability information on processes and using them

to really control the overall process. The designed

solution will raise the overall safety and

effectiveness thanks to:

Unique identification of patient and bags through

RFId tags;

Consolidated and shared information among all

involved units throughout the process;

User-friendly mobile application supporting

bedside activities (from donation to transplantation),

tracing significant steps (time, operation, user),

recording adverse reactions;

Sharing of adverse reaction digital information

between doctor and other units involved;

Integrating all traceability and stock information

to Transfusion Service and Stem Cell Lab

information systems, in order to unify information

on patients, cell units and stocks.

A model of the new process configuration, as

well as a draft architectural model for the ICT

solution will be provided soon.

The clinical relevance of the project refers to the

purpose to directly measure the impact of the

proposed solutions (methods, organization, tools) on

collection, processing and transplantation

procedures. This will regard: product quality, patient

safety, process quality assurance, traceability of

transplantation flows for clinicians and technical

staff (e.g. vigilance on hematopoietic stem cells and

therapeutic cells, traceability information, adverse

reaction, etc.). The impact on cell quality will also

be assessed analyzing vitality and other indicators,

to understand how the new procedures and e.g. radio

frequency radiation could affect their features.

In fact, the primary result will be an increase in

patient safety and in secure management of the

processes, thanks to secure and unique RFId

identification of all items and people involved.

Besides, this will be the first project able to realize a

complete RFId traceability and tracking system of

HSC and TC transplantation, transferable in order to

give coverage to an area now scarcely garrisoned.

This will also be measured concretely assessing As

Is vs To Be process risk levels using methodologies

like the Health-Care Failure Mode And Effect

Analysis (HFMEA).

The Istituto’s experience in safe transfusion

management with the RFId platform proves that the

pervasive use of AICD technologies will force to a

process review increasing its compliance to

international standards and fostering a higher level

of general accuracy in activities. Moreover, an

increase in adverse events notification will surely be

obtained by supporting bedside activities with

mobile solutions fully integrated with the Hospital

Information System. This would raise statistical

relevence of adverse events notified to the

Transfusion Service and improve process monitoring

capabilities.

Finally, the project approach aims at achieving a

general value model and a corresponding ICT

solution which is easily exportable to other

healthcare organizations. This will be guaranteed by

the use of recognized methodological frameworks,

recommended international guidelines (FACT-

JACIE procedures should be implemented by all

centres dealing with stem cells), international

technology standards (e.g. ISBT 128, HL7-Health

Level Seven, standard Web Services, etc.). But

above all this will be guaranteed also by tight

collaboration with physicians in designing and

developing the solution and will be validated by

other Italian hospitals collaborating with Istituto.

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