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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013) October 17-18 2013, Windsor, United Kingdom Inas Ezz Electronic Records in Healthcare: The Need for Quality Standards 1 ELECTRONIC RECORDS IN HELATHCARE: THE NEED FOR QUALITY STANDARDS Inas Ezz, Sadat Academy for Management Sciences, Cairo, Egypt; Brunel University, London, UK, [email protected], [email protected] Abstract This paper has investigated the issue of standardization of electronic records in healthcare, required to facilitate shareability and interoperability concerning patient data. The literature as the practice has even shown that some basic terms do not mean the same thing to different researchers and stakeholders. This paper has discussed the need for a balance between standardization and understanding the variable nature of healthcare information systems and patients. These arguments have been investigated in the context of an exploratory case addressing one of the advanced oncology centres in the US. This paper concludes to that there is a need to suggest a maturity model for electronic records in healthcare information systems and achieve an appropriate balance between standardization and flexibility. Keywords: Healthcare Information Systems, Electronic Patient Records, Electronic Health Records, Electronic Medical Records, Maturity Models 1 INTRODUCTION Electronic patients records (EPR) are part of the underlying infrastructure supporting healthcare information systems. Thus, in this section, we are going to provide a brief overview about what is meant by information systems in healthcare. The use of information systems and its underlying technologies have been addressed in the literature using different terms such as health information technologies (Furukawa et al., 2006), healthcare information systems (Johnson, 2011; Teixeira et al, 2010) the use of IT in healthcare (Haux et al., 2002), IT applications in healthcare (Chiasson and Davidson, 2004) etc. In this paper, we use the term healthcare information systems to combine all these terms, or others that address the use of ICT to support healthcare applications. According to Paul and Ezz (2011), it is postulated that healthcare information systems can also offer economic benefits through efficiency savings; for example by providing the data that helps to identify potential bottlenecks in the provision and administration of care (Johnson, 2011). Perera et al. (2011) add that health information sharing between patients and their heath care providers may improve diagnoses, increase patient education and promote self-care. Analyses of de-identified healthcare utilization data have proven useful to assess patterns of care, therapy effectiveness and safety. Although there are multiple potential benefits of healthcare information systems, there are already several high profile failures (Johnson, 2011; Teixeira et al, 2010; Pai and Huang, 2011; Jha et al, 2009). Some works report how difficult it is to successfully introduce ICTs in this domain Haux et al. (2002) and Rigby et al. (2000).

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Page 1: ELECTRONIC RECORDS IN HELATHCARE: THE NEED FOR …emcis.eu/Emcis_archive/EMCIS/EMCIS2013/EMCISWebsite...level, job experience and other factors. The literature almost unanimously proposes

European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 1

ELECTRONIC RECORDS IN HELATHCARE: THE NEED

FOR QUALITY STANDARDS

Inas Ezz, Sadat Academy for Management Sciences, Cairo, Egypt; Brunel University, London, UK,

[email protected], [email protected]

Abstract

This paper has investigated the issue of standardization of electronic records in healthcare,

required to facilitate shareability and interoperability concerning patient data. The literature as

the practice has even shown that some basic terms do not mean the same thing to different

researchers and stakeholders. This paper has discussed the need for a balance between

standardization and understanding the variable nature of healthcare information systems and

patients. These arguments have been investigated in the context of an exploratory case

addressing one of the advanced oncology centres in the US. This paper concludes to that there

is a need to suggest a maturity model for electronic records in healthcare information systems

and achieve an appropriate balance between standardization and flexibility.

Keywords: Healthcare Information Systems, Electronic Patient Records, Electronic Health

Records, Electronic Medical Records, Maturity Models

1 INTRODUCTION

Electronic patients records (EPR) are part of the underlying infrastructure supporting healthcare

information systems. Thus, in this section, we are going to provide a brief overview about what is

meant by information systems in healthcare. The use of information systems and its underlying

technologies have been addressed in the literature using different terms such as health information

technologies (Furukawa et al., 2006), healthcare information systems (Johnson, 2011; Teixeira et al,

2010) the use of IT in healthcare (Haux et al., 2002), IT applications in healthcare (Chiasson and

Davidson, 2004) etc. In this paper, we use the term healthcare information systems to combine all

these terms, or others that address the use of ICT to support healthcare applications.

According to Paul and Ezz (2011), it is postulated that healthcare information systems can also offer

economic benefits through efficiency savings; for example by providing the data that helps to identify

potential bottlenecks in the provision and administration of care (Johnson, 2011). Perera et al. (2011)

add that health information sharing between patients and their heath care providers may improve

diagnoses, increase patient education and promote self-care. Analyses of de-identified healthcare

utilization data have proven useful to assess patterns of care, therapy effectiveness and safety.

Although there are multiple potential benefits of healthcare information systems, there are already

several high profile failures (Johnson, 2011; Teixeira et al, 2010; Pai and Huang, 2011; Jha et al,

2009). Some works report how difficult it is to successfully introduce ICTs in this domain Haux et al.

(2002) and Rigby et al. (2000).

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 2

The use of EPRs as the primary source of patient medical information is still relatively rare, but

increasing from a slow start in Canadian, British and American primary care. In addition to improved

legibility, the organized note structure of many EPRs supports high quality patient summaries

desirable for shared clinical care. Similarly the detailed healthcare information in EPRs makes them

important sources of information for clinical, research and policy (Jha et al, 2009).

The aim of this research is to investigate the issue of standardization of electronic records in

healthcare. The research is willing to investigate whether there are specific standards being followed

in this context to facilitate the shareability and interoperability concerning patient data. The question

here is if this is not the case can we reach this standardization?

In order to investigate this matter,, section 2 section will discuss the different types of electronic

records as discussed in the literature and popular European and American quality standards. Section 3

provides an attempt to answer the question whether electronic records in healthcare can be

standardized, while section 4 discusses different maturity models related to electronic records in health

care. Section 5 presents the findings of the US oncology medical centre case under investigation.

Finally, the paper ends up with some concluding remarks in section 6.

2 ELECTRONIC RECORDS IN HEALTHCARE

According to De Veer and Francke (2010) more and more health care organizations are introducing

electronic systems to store patient information. These are known as electronic patient records (EPR),

although the systems can be labelled differently locally, using terms such as electronic nursing

records, electronic health records (EHR), or computer-based patient record systems. The

functionalities of these systems may differ, e.g. some are used by nursing staff only, whereas others

are also used by physicians and other professionals. Characteristics of the professionals themselves

play an important role in whether new work routines are implemented and actually used (Fleuren et

al., 2004; Francke et al., 2008). This matter discussed by De Veer and Francke (2010) is an important

factor that adds to the complexity of the EPR issue. In this context, they suggested a model to predict

the attitude of nursing staff (as one of the EPR stakeholders) towards using EPR. This incorporates

some factors that affect the attitude towards using the EPR including for example, the educational

level, job experience and other factors.

The literature almost unanimously proposes that electronic health records (EHR) or electronic patient

records (EPR) have the potential to improve patient care (Teixeira et al., 2010). Others such as Jha et

al. (2009) emphasise the gains to be made from efficient and effective health care provision. The

potential benefits of EPR systems are claimed to be organizational issues such as improving the

exchange of information between healthcare facilities and the support of standardized procedures that

can help to increase consistency between different service providers. Further, EPR should be able to

ensure minimum standards across the trajectory of care when patients move between different

specializations.

The question here is, are EPRs and EHRs interchangeable terms as been presented in the literature?

This matter will be discussed in this section, through referring to the literature as well as some quality

standards.

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 3

2.1 Basic Terminologies

As Ken and Kalra (2008) discuss, the importance of the EHR has been obvious through the European

Union’s Health Telematics Framework Programmes, which started with its third Framework

Programme in 1992 and continuing through to its seventh in 2007. Considerable research has been

undertaken over the past 15 years to explore the user requirements for adopting EHRs (for example,

published by the Good European Health Record Project (Ingram et al., 1992; Heard et al., 1993) and

the EHCR Support Action (Dixon et al., 2001). EHR demonstrators have been established in many

European countries, through these R&D projects and subsequently through national programmes, as

the strategic importance of EHRs has grown (Kalra, 2004).

The American College of Obstetricians and Gynaecologists(2010) argue that the electronic health

record (EHR) has the potential to improve the quality, safety, and efficiency of patient care when fully

implemented (Bates, 2003). Further, the use of the EHR can improve communication among health

care providers and increase team effort among providers. Its use can assist with medication safety,

tracking, and reporting and eliminate concerns about the legibility of paper medical records. Most

importantly, its use has been shown to have an effect on quality of care through optimized compliance

with guidelines (Classen, 2010).

The use of preassembled ordering and documenting tools within an EHR may simplify the

documentation process, although care must be taken when using templates to avoid importing previous

notes without updating data, assessment, and plans. When using templates, the record must be

reviewed and edited to ensure that it accurately documents the patient encounter. Record uniformity

may reduce practice variations and can standardize health care, procedures, and follow-up (Brokel and

Harrison, 2009). In addition, a more complete record can be created by offering staff additional

questions, information, or alerts (Bernstein and Merkatz, 2007). However, like paper medical records,

EHRs are only as accurate as the information entered into them. Electronic health records provide the

benefit of improving the legibility of prescriptions, potentially reducing the risk of some medication

errors. Healthcare providers have the benefit of accessing information from an online formulary,

assuming that it is updated on an ongoing basis, as well as providing real-time medication alerts. It

also can aid with medication reconciliation for each patient (The American College of Obstetricians

and Gynaecologists, 2010).

The ability of an EHR to store and retrieve data makes it a logical tool to improve the quality of

patient care. Using an EHR can consolidate patient information, such as diagnoses, medications, and

test results, which may enable providers to deliver safer, more effective health care. Decision-making

support, such as prompts and reminders when tests are due or when specific care does not meet

guidelines, provides the clinician with a tool to provide quality care (The American College of

Obstetricians and Gynaecologists, 2010). .

As discussed by the American College of Obstetricians and Gynaecologists (2010), electronic health

records can open communication with patients through online secure portals and reception area kiosks.

These encourage patient partnering by allowing patients to enter personal or medical history

information, make appointments, request refills on prescriptions, or obtain laboratory results. These

kiosks and web portals can also be made interactive so patients may receive targeted education materials and other information (Gill, 2009).

One of the most important features of EHR that distinguishes it from other terms, is that the

acceptance of its implementation within an institution is facilitated when a single, specific program is

installed across a network of computers, along with the establishment of an information technology

support department provided by the organization. This allows uniformity of communication and a

complete interface between group practices and the institution. More importantly, it allows the

institution to provide an information technology support department, through partnership with a

particular vendor. The members of the information technology department can meet with clinicians

regularly to review usage, navigation, and updates to the system. Also, the information technology

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 4

support department should be available, at any time, for immediate consultation to troubleshoot any

system problems, such as retrieval of lost data due to power outages, or to assist the clinician in

efficiently using the system. The efficiency of the department is dependent on how well it can train

and assist clinicians, along with upgrading the system as problems or inefficiencies are discovered (The American College of Obstetricians and Gynaecologists, 2010)..

2.2 Electronic Records in Healthcare and Quality Standards

Concerning standardisation of EHR as Ken and Kalra (2008) mention, CEN is the principal legislative

standardisation body for Europe; Technical Committee 251 has responsibility for health informatics

(interoperability) standards. Since 1990 CEN TC/251 has regarded the Electronic Healthcare Record

as one of the most important and most urgent areas for the establishment of European standards. In

2002 CEN TC/251 launched a new Task Force to update the 1999 pre-standard for Electronic

Healthcare Record Communications, to produce a first full standard (EN 13606). One In 2003 ISO

Technical Committee 215 (Health Informatics) agreed to collaborate with CEN on a parallel

standardisation path for EHR Communications, under the same lead, and it is anticipated that these

two bodies will each endorse the 13606 .

2.2.1 European Quality Standards

Investigating the recent popular European quality standards in the context of these terms we found

some relationships and differences. For example, according to BSI (2011) the BS ISO 18308: 2011

the EHR is defined as one or more repositories, physically or virtually integrated, of information in

computer processable form, relevant to the wellness, health and healthcare of an individual, capable of

being stored and communicated securely and of being accessible by multiple authorized users,

represented according to a standardized or commonly agreed logical information model. Its primary

purpose is the support of life-long, effective, high quality and safe integrated healthcare. This means

that on one hand the scope of the EHR is recognized as being broader than the documentation of

illnesses and their prevention and treatment. The systems and services that are deemed potential

contributors to an EHR will increasingly include systems capturing complementary therapy, wellness,

and home care information in addition to the conventional clinical systems within healthcare provider

organizations.

According to the BSI (2012a) PD ISO/TR 14639-1:2012 standard, the EHR should:

enable the consistent capture, processing, retention, protection and communication of health

information such that interoperability is achieved in support of shared care, improved quality

of care, effective resource management, providing evidence of actions taken in health(care),

and in support of the uses of anonymized information for health system management.

enable authorized users to access health information that is relevant, intact, appropriate to

their permissions and within a timeframe that is appropriate to the context.

enable authorized users to access health information seamlessly and as originally organized,

independently of the EHR systems and of the physical formats in which it was originally

stored.

enable the communication of all health information between care settings, subject to

appropriate consent and access rights, to a sufficient quality to support safe shared clinical

care.

help ensure that subjects of care receive the most appropriate care as quickly and safely.

Further, the EHRA shall support integrated care including collaborative multi-disciplinary

care and case management across different healthcare sectors and settings (e.g. primary care,

acute hospitals, allied health, home-based care).

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 5

On the other hand, the notion of the personal health record (PHR)2 (this is the term being used for

EPR according to this standard) is also maturing internationally and, and its requirements have been

deliberately worded to be inclusive of the PHR in general terms, i.e. most of these EHR requirements

will also apply to the PHR.

Further The British Standards Institution BSI (2012a), provides some definitions of relevant terms as

based on the PD ISO/TR 14639-1:2012 standard. For example, the electronic medical record EMR is

electronic record of an individual in a physician’s office or clinic, which is typically in one setting and

is provider-centric, while the electronic patient record EPR is an electronic record of an individual in a

hospital or health care facility, which is typically in one organisation and is facility-centric.

The BSI (2012b) provides further clarification in its BS ISO 16527 Personal Health Record System

Functional Model, where the difference between Personal Health Record (PHR) versus a Personal

Health Record System (PHR-S) is discussed. The PHR WG makes a clear distinction between a PHR

and a PHR System (PHR-S). The PHR is the underlying record (e.g., data, information, pictures,

sounds, graphs, or videos) that the software functionality of a PHR-S maintains. There has been much

discussion surrounding the definition of a personal health record. The PHR-S FM does not attempt to

define the PHR, but rather to identify system features and functions necessary to create and effectively

manage PHRs. The PHR-S FM offers examples of data elements, but is not intended to provide details

necessary to specify a data model.

The overarching theme of a PHR-S involves a patient-centric tool that is controlled, for the most part,

by the individual PHR Account Holder. A PHR-S should be immediately available electronically and

able to link to other systems. The PHR-S provides functionality to help an individual maintain a

longitudinal view of his or her health history, and may be comprised of information from a number of

sources – e.g., from providers and health plans, as well as from the individual. Data collected by the

system is administrative and/or clinical, and the tool may provide access to health-related forms (e.g.,

Advance Directives) and advice (e.g., diet, exercise, or disease management). A PHR-S might also

help the individual collect behavioral health, public health, patient-entered and patient-accessed data

(including medical monitoring devices), medication information, care management plans and the like,

and might be connected to providers, laboratories, pharmacies, nursing homes, hospitals and other

institutions and clinical resources (BSI, 2012b).

At its core, the PHR-S should provide the ability for the individual to capture and maintain

demographic, insurance coverage, and provider information. It should also provide the ability to

capture health history in the form of a health summary, problems, conditions, symptoms, allergies,

medications, laboratory and other test results, immunizations and encounters. Additionally, personal

care planning features such as Advance Directives and care plans should be available. The system

must be secure and have appropriate identity and access management capabilities, and must use

standard nomenclature, coding and data exchange standards for consistency and interoperability. A

host of optional features have been addressed over the course of this initiative, including secure

messaging, graphical presentation of test results, patient education, guideline-based reminders,

appointment scheduling and reminders, drug-drug interactions, formulary management, health care

cost comparisons, document storage and clinical trial eligibility. The effective use of a PHR-S is a key

point for improving healthcare in terms of effective self-management, patient-provider communication

and quality objectives (BSI, 2012b). Table 1 sums up the differences between the EPR, EHR, and

EMR definitions according to the recent BSI PD ISO/TR 14639-1:2012 (BSI, 2012 a).

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

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Electronic Records in Healthcare: The Need for Quality Standards 6

Electronic health record

EHR

Electronic medical record

EMR

Electronic patient record

EPR

information relevant to the

wellness, health and healthcare of

an individual, in computer-

processable form and represented

according to a standardized

information model, or the

longitudinal electronic record of an

individual that contains or virtually

interlines to data in multiple EMRs

and EPRs, which is to be shared

and/or interoperable across

healthcare settings and is patient-

centric

Adapted from ISO 18308:2011 and

the European 2011 eHealth

Strategies Final Report, January

2011.

electronic record of an individual in

a physician’s office or clinic, which

is typically in one setting and is

provider-centric

[European 2011 eHealth Strategies

Final Report, January 2011]

electronic record of an individual in

a hospital or health care facility,

which is typically in one

organisation and is facility-centric

[European 2011 eHealth Strategies

Final Report, January 2011]

Table 1. EHR, EMR, and EPR Comparison (based on BSI, 2012 a)

2.2.2 American Quality Standards

Investigating American quality standards in this context, through reviewing the literature and ranking,

and as conducted during the case study research we have found out that there is no common American

quality standard in the context of healthcare information systems and electronic records. Rather, there

are multiple standards that could be referred to. However, there have been some initiatives in the

context of standardization such as the ‘The Accountable Care Organization 2013 Program’, which is

attempting to promote standardization through a Medicare or Medicaid Electronic Health Record

(EHR) Incentive Program. The American Recovery and Reinvestment Act of 2009 (ARRA) provides

incentive payments for Medicare and Medicaid providers who “adopt, implement, upgrade, or

meaningfully use [MU] certified electronic health records (EHR) technology.” These incentives are

intended to significantly improve health care processes and outcomes, and are part of the larger Health

Information Technology for Economic and Clinical Health (HITECH) Act. One other of this initiative

to define the relationship of data coming from diverse source systems (for example, clinical laboratory

information management systems, order entry systems, pharmacy information management systems,

dictation systems), and the data stored in the Electronic Health Record. Recalling that the EHR is the

primary repository for information from various sources, the structure of the EHR is receptive to the

data that flow from other systems. Further, in order to accelerate the adoption of EHRs, this guide

provides a common vocabulary, perspective, and references for those developing, purchasing, and

implementing EHR systems, but it does not deal either with implementation or procurement. (RTI

International, 2012). However, it is not clear, what the electronic records should exactly contain.

Further initiatives as discussed by Blumenthal ( 2011) has started in February 2009 by the U.S.

government when it has launched an unprecedented effort to reengineer the way the country collects,

stores, and uses health information. This effort was embodied in the Health Information Technology

for Economic and Clinical Health (HITECH) Act. The HITECH Act set aside up to $29 billion over

10 years to support the adoption and “meaningful use” of electronic health records (EHRs) (i.e., use

intended to improve health and health care) and other types of health information technology.

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 7

One of the American standards that have been introduced since the late 90s lists some basic contents

that such records should contain. For Example, according to the ASTM (1999) standard, electronic

Health Record (EHR), the record carries all health related information about a patient over time. It

includes such things as observations or descriptions of the patient (for example, the physician’s or

nurse practitioner’s history and physical, laboratory tests, diagnostic imaging reports), provider’s

orders for observations and treatments, documentation about the actions carried out (for example,

therapies or drugs administered), patient identifying information, legal permissions, and so on. While

this standard describes the EHR more like the BSI definition of EPR, it further continues to describe

the input which is primary record (paper oriented record). As mentioned they depict the full range of

data that will compose the EHR but described in familiar terms. Table 2 shows a sample of the data in

such records. However here they entitle it as patient record EPR rather than EHR.

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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)

October 17-18 2013, Windsor, United Kingdom

Inas Ezz

Electronic Records in Healthcare: The Need for Quality Standards 8

Category Subcategory Examples and Components

Patient registration

information

Identifying information Sex, birth date, race

Locating information Home address, home phone, work phone

Insurance information Name of plan

Guarantor information

Patient problem list

Problem number

Problem name

Date of onset, status

Patient extended

encounters

Hospitalization admission

records

Insurance information (for current encounter),

guarantor information (for current encounter), chief

complaint, diagnoses, clinical variables(observations,

tests, measurements), final diagnosis/problem,

corrections to registration information, procedures

performed, etc.

Encounters

Practitioner hospital notes

Practitioner visit notes

Home healthcare notes

Hospital discharge summary

Office/clinic visit

Home healthcare visit

Practitioner visit within

Extended stay

Emergency room visit

Patient care plans

Clinical roadmaps Assessment data

Chronic disease management

Plans delineating therapy, education, scheduled

appointments

Plans for specific patient

problems

Orders

Medication

orders/prescription

Test orders

(both continuing orders, for example, Hgb QAM,

and point orders, for

example, glucose stat)

Diet orders

Other treatment orders

Physical therapy order

Occupational therapy order

Respiratory therapy order

Nursing treatments order

Other observation orders

Nursing observations (also

independent of orders)

Consults (to variety of

clinical

specialists)

Nursing interventions

Service Instances

Confirmation of receipt of

orders

Documentation of

completion of

each step of process (for

example,

MAR report)

Procedures

Surgical procedure Pre-procedure orders, pre-operative diagnosis, procedure

identifier, provider(s) performing procedures, permissions for

procedure, procedure note, duration of procedure, medication

used, immunizations, complications, final diagnosis, post-

operative orders, after care plans

Table 2. Contents of the Traditional Patient Record (ASTM,1999)

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Electronic Records in Healthcare: The Need for Quality Standards 9

Category Subcategory Examples and Components

Procedures

Outpatient procedures

Invasive diagnostic studies

Bedside procedures

Imaging studies

Thyroid scan, chest X-ray, cardiac echoes, OB ultrasound,

Vascular dopplers, cardiac catheterizations

Physiologic tracings EEGs, EKGs, prenatal monitors, cardiac monitors

Other special studies Glaucoma fields, pulmonary function, sleep studies

Practitioner notes Physicians’, nurses’, physical therapists’, etc., notes

Provider discrete observation

Blood pressure, heart rate, skin fold thickness, eye

tonometry, infant’s head circumference

Identifying information Patient’s name and identifying number

Health history

Chief complaint

Source of history

Present illness

Family Hx

Social Hx

Functional status Hx

Travel Hx

Occupational Hx

Childhood disease Hx

Surgical procedures Hx

Allergy Hx

Medication Hx

Review of systems

Smoking Hx total

Smoking Hx current, etc.

Physical exam

General status Px

Vital signs Px

Skin Px

Head Px

Eyes Px

Ears Px

Nose Px

Mouth/throat/teeth Px

Thorax/lungs Px

Breasts Px

Heart Px, etc.

Toxic exposures

Nursing assessments

Legal documents Surgical releases

Organ donor permissions

Advance directives (release of

documents)

Schedules (surgery/clinic, etc.) Requests for resource Send patient to eye clinic

Assignment of resource

Documentation of delivery to

resource and return

Supplies and equipment Consumables (434’s)

Attachments

Table 2. Contents of the Traditional Patient Record Continued (ASTM , 1999)

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Electronic Records in Healthcare: The Need for Quality Standards 10

Further, although as been clarified above by the ASTM (1999) standard, EHR does not only include

all health related information about a patient over time when presenting a table describing the record

content structure data categories, segments and entity relationship, they call it again patient record as

described in Table 3.

Data Category and Segments Entity

Administrative Data

I

II

III

IV

Demographics

Legal agreements

Financial information

Provider/practitioner

Patient

Patient

Patient

Provider

Clinical Data: Problem/Diagnoses

V

Problem list

Problem

Clinical Data: History

VI

VII

VIII

Immunization

Hazardous stressor exposure

Health history

Service instance

Observation

Observation

Clinical Data: Assessments/Exams

IX

*

Assessments

Patient reported data

Observations

Observation

Clinical Data: Care/Treatment

Plans

X

Clinical orders

Orders

Clinical Data: Services

XI

XII

XIII

Diagnostic tests

Medications

Scheduled appointment/ events

Observations

Service Instance

Encounter

Administrative Data: Encounters

XIV

Administrative data

Encounter disposition

Patient

Encounter

Clinical Data: Encounters

Chief complaint/ diagnoses

Clinical course

Therapy/procedures

Observation

Observation

Service

instance

Table 3. Patient Record Content Structure Data Categories,Segments and Entity Relationships ASTM (1999)

3 CAN THE HEALTH RECORD BE STANDARDIZED?

It has to be well understood that the healthcare priorities in different countries is variable. In this

section we are going to provide some examples from BSI PD ISO/TR 14639-1:2012 BSI (2012a)

standard. Although that one of the reasons this standard has been developed was to provide guidance

for developing and emerging countries and for the many international groups that conduct health

programs in the developing and emerging world, we will use this standard in a different way in this

section. We will basically focus on highlighting the differences between healthcare information

systems in general and electronic records in healthcare in particular. As confirmed by this standard,

part of ISO/TR 14639 arises from the recognition that currently there is considerable diversity

internationally in the approach and scope of development and implementation of national health

information systems (HIS).

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Electronic Records in Healthcare: The Need for Quality Standards 11

3.1 Healthcare Standards

BSI PD ISO/TR 14639-1:2012 has described the healthcare information systems initiatives in some

selected countries such as Australia, Canada, Brazil, India according to multiple criteria including for

example, the national health system, the focus of the national health system, the components of the

national health system, the national health policies, the electronic health record, vertical systems

(disease centred systems), national datawarehouse, standards in use (clinical vocabulary),

interoperability, security, standards development, insurance systems. The most important issue here is

that as a start, the healthcare systems are not and cannot be exactly standard. One main reason is that

the stakeholders and supporting bodies are different from country to another. Further, the national

health system differs depending on the health threats and their priorities. For example the focus in

Australia is on chronic disease including arthritis and musculoskeletal conditions, asthma, chronic

obstructive pulmonary disorder (COPD) and other respiratory diseases, cancer control, cardiovascular

health, diabetes, mental health, and reducing common risk factors such as smoking, alcohol, substance

abuse, obesity, diet, inactivity, and hypertension. Further, the focus is also on indigenous health as

well as rural and regional healthcare. Comparing this with Canada, we can see that the focus of

national health care systems is mainly, patient safety, quality of care, access and wait time of care, the

supply and distribution of health human resources, increasing incidence of chronic disease, an aging

population and the long term sustainability of the health system (BSI, 2012a).

3.2 Electronic Records in Healthcare

Similarly to what has been discussed in the context of healthcare information systems, and in addition

to the inconsistency of the terms related to electronic in the literature, there is no standardization in the

initiatives concerning electronic records in health care while we have investigated the cases presented

by BSI PD ISO/TR 14639-1:2012. For example, in Australia, the government has supported National

Health and Hospitals Reform (NHHR) package included AUD 466,7 million toward initial

implementation of shared personally–controlled PCEHR capability as a national eHealth priority. Prior

to this initiative, there had been no funded policy aimed at delivery of a national system of electronic

health records, although trials were conducted and proposals put forward under the former

HealthConnect program. The aim is to provide every Australian with a PCEHR that is controlled by

them, ensuring individuals’ privacy, improving efficiency in the healthcare system through

streamlining access to patient information thereby reducing duplication and improving use of scarce

resources, providing continuity of care by enabling access to patient information at the point of care,

and improving safety and quality in healthcare (BSI, 2012a).

In Canada, according to the BSI PD ISO/TR 14639-1:2012 electronic health records that coordinate

care between professionals, telehealth that offers remote patient monitoring in the home and patient

portals are expected to become increasingly important as means of supporting new and more effective

care in the future. Currently there is a wide range in the adoption of automation of patient health

information in the various practice settings in Canada, where the highest level of adoption and use of

electronic records is in the hospital sector; nearly all larger community and tertiary care centres now

have electronic records systems that span the various clinical services and programs. Smaller hospitals

have a lower level of automation, but nonetheless have generally automated many core functions. In

the ambulatory clinic environment, electronic record usage is still limited. Despite a number of heavily

funded initiatives, physician adoption of electronic medical records in primary care is very low in

Canada compared to many OECD countries (The Commonwealth Fund, 2009). Since early in 2004,

one of the major differentiators of the Canadian health information system landscape has been the

development of a common Electronic Health Record Solution (EHRS) Blueprint and the pan-Canadian

standards necessary to support EHR interoperability (BSI, 2012a).

In Brazil, listed by the as BSI PD ISO/TR 14639-1:2012 in 1999, the Ministry of Health (MoH)

proposed the National Health Card Project aiming at defining standards for uniquely identifying the

individual, the health organization and the healthcare worker as well as defining a core patient dataset

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for registering clinical data. In 2003, the MoH unified the registries of healthcare (HC) providers and

workers, creating a national registry with unique identifiers. The use of this registry is mandatory for

all HC providers in the country no matter whether public or private. These two projects had a major

impact on how health information systems became to be regarded (PAHO, 1997). The national

database of uniquely identified persons holds 180 million people and the national registry of HC

providers has 228 thousand records with 2,7 million HC workers. The standards are to be made

publicly available and updated on the website. The relevant standard chosen in the context of

electronic records is the EHR information model: OpenEHR (BSI, 2012a).

In India, according to the BSI PD ISO/TR 14639-1:2012 even the vocabularies for medical data are

not in place at the moment, but are recognized as important and are part of the country’s strategic plan.

As part of the concern with interoperability, assessment is currently being done on how existing HIS

comply with standards for interoperability in order to help define strategic actions. .In September

2010, the Ministry of Health and Family Welfare of the Government of India formed an Expert

Committee for Standardization of Electronic Medical Records (BSI, 2012a).

To sum up, the initiatives in different countries are at different stages, have variable objectives, and

the terms being used are not standard. For example, as seen above, personally–controlled PCEHR in

Australia, EHR is being used in Canada, in Brazil the national program is called National Health Card

while the standard followed later is the OpenEHR. Finally India is starting to focus on

standardization, while the term being used is Electronic Medical Records.

3.3 Patient Centred View and Electronic Records in Healthcare

According to BARBER et al. (2011), it is argued that user-centered (UC) design and implemented IT

is an unquestionable principle and a golden rule for a technology that is: effective for both users and

organizations, satisfactory for the end-users and, most importantly, safe for patients. Conclusively UC

IT is an ethical call. They support this idea by highlighting Han et al. (2005) point of view concerning

the matter that technology in healthcare can kill, which means that safety should be the number one

priority for any technology used for processes of care. Further, as they emphasize, research in human

factors has demonstrated how user-centered design contributes to a safer technology (DoH and Design

Council, 2003) and therefore, ergonomic principles and UCD methods should be applied to most

informatics and systems development projects. Barber et al. (2011) have seen in their research how

clinicians were asked to use electronic patient record systems implemented with a top-down approach

and very limited user involvement.

Confirming this matter, especially in the context of patients, who are supposed to be the target

beneficiaries of healthcare systems, Gordon et al. (2013) mention that transdisciplinary approaches

have incorporated patient-centered care into research, practice, and health care policy. The Institute of

Medicine (2001) describes patient-centered care as being responsive and respectful of the individual's

needs, preferences, culture, beliefs, and values. These factors guide treatment decisions and influence

communication and goal setting. Treatment is not limited to providing culturally and linguistically

appropriate services, but culturally sensitive communication that reflects understanding, respect, and

appreciation of cultural diversity (U.S. Department of Health and Human Services, 2007).

Health care professionals must determine that the patient is literate and, most importantly, has the

cognitive and language ability to understand and follow a recommended treatment plan. Therefore, an

important application of a transdisciplinary model is intensive, ongoing interaction among team

members from different disciplines enabling an exchange of information, knowledge, and skills in an

effort to work in unison (King et al., 2009). Social and cultural determinants must be seen in the

context of the individual and the community that include the patient's support system. Diversity

includes all aspects of culture, as well as socioeconomic status, religion, disability or ableness, age,

gender, race, and sexual orientation, which all interact in a dynamic manner (Falender & Shafranske,

2004). The consideration of cognitive abilities, language, education, health literacy, as well as

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environmental and financial factors, provides an opportunity to view the patient in a broader context

and leads to a decrease in health disparities. Patient information obtained by the health care team

members must be shared across the various disciplines that are involved in the patient's care. Sharing

information facilitates team member's access to the patient's life situation, which leads to a more

comprehensive plan of care.

Cultural beliefs, social, psychological, and spiritual needs, and values influence patient and

family/support system's concepts of health and illness and the meaning of visible and hidden disability

(e.g., traumatic brain injury (TBI), multiple sclerosis), illness, and loss Gordon & Zaccario, 2010).

For example, an individual with a TBI may be physically independent, but have distressing cognitive

deficits that are not visible to others. Limited knowledge and understanding of these factors can also

affect an understanding of how the patient assigns meaning to and experiences pain. If health care

professionals do not explore cultural, environmental, and economic factors related to each patient,

managing their illness and pain may result in unnecessary readmissions and poor health outcomes. For

example, a patient cannot be expected to adhere to a pain medication regimen if the health care team is

unaware that the patient does not have the means to pay for that medication or there are certain

cultural taboos to taking traditional pain medication.

Identifying and sharing information about cultural nuances (e.g., avoiding eye contact as a sign of

respect for authority, leaving all decision-making to a particular family member, or not reporting pain

because it is a sign of weakness), across the continuum of care can contribute to a successful

transdisciplinary approach to pain management. The integration of the patient's family, community,

and other resources provides the foundation for culturally sensitive transdisciplinary care.

Furter, the idea of starting to focus on healthcare quality and patient satisfaction has been recognized

by several authors as present Al Badri et al. (2009). This included multiple efforts such as (Ygge and

Arnetz, 2001; Jackson et al., 2001; Badri et al., 2005, 2008; Zineldin, 2006; Labarere et al., 2001).

Investigating the patient as a target stakeholder of healthcare systems, add to the complexity of the

system. Patients themselves are complex. When discussing the patient as a target stakeholder of the

healthcare system, we need to discuss the nature of disease itself, which is nonlinear and (Denis, and

Letellier, 2012).

Investigating the matter of patient centric view from the healthcare standards perspective, we can see

that this matter has been addressed. For example, The British Standards Institution BSI (2012b) has

emphasized that every health care organization has to recognize who is the customer (patient, patient's

relative, payer, another health care unit, authorities etc.) and define the customer's needs and

expectations. Further, as been stressed, in health care the main customer is the patient. The health care

services are then designed and established to meet the patient's needs. Patient satisfaction should be

properly monitored. In further context of customer focus in healthcare, EN ISO 9000:2005

emphasized that organizations depend on their customers and therefore should understand current and

future customer needs, should meet customer requirements and strive to exceed customer expectations.

Thus, in healthcare organizations, top management should ensure that:

- information on patients' rights is available,

- the patient and his/her family are shown consideration and respect,

- the dignity and integrity of the patients are preserved,

- the patient is kept informed and permitted to participate in the care,

- suggestions and complaints from the patients and their families/next of kin are investigated and acted

upon,

- informed consent by the patient is obtained before the health care services are delivered,

- the patient or, when appropriate, their family/next of kin is informed when the patient has suffered an

adverse event,

- the organization has a procedure determining to what extent anonymous and non-anonymous data are

given to interested parties outside the organization,

- cooperation throughout the continuum of care irrespective of the health care provider takes place.

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Further, according to BSI PD ISO/TR 14639-1:2012 all countries identified in their report (Canada,

Australia, Brazil, India, and Kenya) have realized the importance of moving from provider-centric app

roaches to a patient centric approach that will ultimately allow for the construction of a shared

electronic health record Importance of standards All countries recognized the importance of standards

and their adoption to guarantee interoperability between health information systems.

However, the user centred development in general and patient centred development in particular, is

one of the main challenges of standardization of electronic records in healthcare, as each patient is a

unique case that is dynamic and might change over time. . Further, as Barbeer et al. mention,

healthcare IT affects and is affected by a large variety of stakeholders. In their research Lichtner et al.

(2010) have been involved in mapping stakeholders for the evaluation of the English Electronic

Prescription Service where the maps were multiple and complex, with a variety of interested parties

whose business were expected to be affected by the introduction of this new infrastructure.

In more simple models of hospital IT, stakeholders can comprise: direct end-users, such as nurses and

doctors asked to use electronic patient record systems; indirect users, such as clinical coders interested

for billing purposes in using the information recorded by clinicians in these systems; and non-users

such as patients whose information is recorded and exchanged and who are affected by others using

IT. Different users might (and often do) have different views on IT. Which user should be at the center

of UC IT and who is to decide? Should patients be involved in design and implementation of health IT

for the sake of patient-centered care? A ‘pure’ user-centered design is, if not a fairytale, then a vision

almost impossible to achieve. Furthermore, end-users do not have to have been involved in the design

of the technology to find it usable and useful. The implementation of the Picture Archiving systems

(PACS) in the UK is an exemplary success story of this kind. Involving users can be expensive and

time consuming, and it may give rise to hard to fulfil expectations. At times it may also be politically

undesirable. (Barber et al., 2011)

3.4 Importance of Basic Standardization

Although it has been clear that the patient centered view suggests that there are different needs to

patients that need to be recorded and thus one patient case cannot be generalized, there is a need of

basic standardization. For the same reason of being patient centred, we need to allow the patient data

to be transferred to other stakeholders including other medical centered. whenever needed. As

Blumenthal (2011) discusses, the ability to effectively transfer electronic health information between

different information systems in various institutions and practices is underdeveloped in the United

States at this time (Adler-Milstein et al., 2010; Adler-Milstein et al., 2011). Thus, providers are

appropriately concerned that their electronic health information systems may not be able to exchange

health information about their patients with other caretakers. This concern creates a rationale to wait

until some uncertain future time when systems for exchange are working well. However, with

thousands of health information technology products and hundreds of thousands of users of health

information technology, developing such exchange solutions and getting them to work seamlessly are

huge challenges. Overcoming these challenges requires collaboration among vendors and users of

health information technology, but these organizations are often fierce competitors in local and

national markets; so collaboration is unlikely to occur naturally. This lack of collaboration creates a

rationale for government to be an honest broker in facilitating technical and policy approaches to the

exchange of health information (Blumenthal, 2011).

4 HEALTHCARE INFORMATION SYSTEMS MATURITY MODEL

According to SEI (2010), a maturity model contains the essential elements of effective

processes for one or more disciplines and describes an evolutionary improvement path from

ad-hoc, immature processes to disciplined, mature processes with improved quality and

effectiveness (Garzás et al., 2013).

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When talking about maturity models as Wendler (2010) suggests, most people first think of Capability

Maturity Model Integration (CMMI). CMMI is a framework that contains best practices for

developing products and services. Its roots lie in the software industry with the CMM for Software

from 1993. The last instalment of the integrated version, CMMI for Development 1.3, was published

in 2010 and combined concepts from software development, systems engineering, and product

development. Besides this, two additional CMMIs for Acquisition and Services are available, too

(Software Engineering Institute, 2010; Wendler, 2010).Widening the purpose in the evolution of

CMM(I) during the last two decades gives a first impression that the applicability of maturity models

is not just restricted to software-related domains but also to management, as an example. In fact, the

maturity concept emerged out of quality management. The concept of maturity stages building on each

other, and therefore offering a simple but effective tool for analysis and measurement, was introduced

by Crosby (1979). He proposed his so called quality management process maturity grid, which

categorized best practices along five maturity stages and six measurement categories (Wendler, 2010).

In this section, we are going to address some maturity models, which are from our point of view

relevant to healthcare information systems in general, and reflect the need for base minimum standards

of electronic records in healthcare in particular. Other maturity levels could be also referred to from

integrative perspective in the context of future research focusing on this matter in particular. Thus, we

will first introduce the e-Health Architecture Maturity Model, the popular CMM(I) software maturity

models, and the project management maturity model.

4.1 eHealth Architecture Maturity Model

Given the outcomes of previous sections, it is worth investigating the stage of healthcare information

systems. Supported by the findings from of ISO/TR 14639 report, the development of an eHealth

architecture maturity model (eHAMM) is proposed for expressing the extent of development of HIS

and eHealth architecture. The model can be used to direct planning and assess progress of national

healthcare information systems (HIS) towards maturity. The maturity model will be elaborated upon in

ISO/TR 14639-2 and includes a methodology for classifying HIS according to descriptions of

architectural components. International standards are an important part of developing robust and

interoperable health information systems. However, international standards have historically described

mature or highly-evolved systems, making implementation challenging for those seeking an entry-

point into standards for strengthening their eHealth architectures. There is a need for systematic

analyses of eHealth architectures within and across countries. The variety in country HIS described in

this part of ISO/TR 14639 suggests the need for an eHealth Architecture Maturity Model (eHAMM)

and methodology for describing country capacity to provide direction in health system strengthening.

An eHealth architecture model has been developed upon which the maturity model described in

ISO/TR 14639-2 is based. This model can be used for system analysis and development of strategy.

By defining indicators against this framework, priorities and gaps can be identified. The countries

described would show different profiles, which would be consistent with their level of maturity and

strategic direction (ISO Health Informatics WIKI, 2011, BSI, 2012a).

Figure 1. presets this schema that usefully identifies and relates the components of an eHealth

architecture framework. It is proposed and discussed in the ISO TC 215 (International Standards

Organisation Technical Committee) Technical Report 14639 while Part 2 is being prepared in

collaboration with WHO. EHR and health information repositories, patient path as well as data

interchange, interoperability and accessibility, and clinical terminology and classification are major

components of this model (ISO Health Informatics WIKI, 2011, BSI, 2012a). However, we suggest that

these matters need to be standardized at a global level, if we are aiming interoperability in the context

of patient data whenever necessary.

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Figure 1. Model of an eHealth Architecture (ISO Health Informatics WIKI, 2011 in BSI, 2012a)

4.2 Software Maturity Models

As healthcare in general and electronic records in healthcare in particular require software as part of its

infrastructure, we are going to refer back to the literature in the context of systems and software

development. The CMM was originally developed by the Software Engineering Institute and it has

been enhanced since then. It was primarily based on the experiences and extensive feedback of

software practitioners and designed to assist the US Department of Defence in software acquisition. It

described an evolutionary software development process improvement path from an ad hoc, immature

process to a mature, disciplined process. The CMM maps organization’s software project process on a

five-level system. The five-levels are defined according to a set of activities described by the SPI

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areas. When combined into the five-level model, each level represents one of five stages of maturity.

The key process areas are summarized in Table 4 (Jiang et al., 2004).

Table 4. Key Process Activities for CMM (Jiang et al., (2004)

A number of software process capability/maturity models have been developed thereafter and these

are being used for software process improvement/assessment by companies (Hauck et al., 2011) At the

moment, the most popular and most widely used certification in the world for cataloging the maturity

of a software development organization is CMMI-DEV (Valdéset al., 2011; Garzás et al., 2013). This

model can be regarded as a further development of the CMM original model, with a lot of similarities.

Suggesting a maturity model for the Spanish software industry based on ISO standards, Garzás et al.

(2013) add an important issue in their model, namely auditing. Further, stakeholder requirement

definition process as well as system requirement analysis process, are considered important tasks in

their model level 2 of maturity. These matters will be discussed in the implications on electronic

records in healthcare in section 4.4.

4.3 Project Management Maturity Model

As Demir and Kocaba (2010) describe, the CMM first refers to project management at level 2, where

the focus is on repeatability, and hence begins the definition of standards for project management. The

PMMM takes these standards to the next level of development by defining a separate model for the

process and practice of project management. The models parallels the CMM as it is described below

(Wysocki, 2004). PMMM helps organizations address fundamental aspects of managing projects,

improve the likelihood of a quality result and successful outcome and reduce the likelihood of risks

impacting projects adversely (OGC, 2006). Reaching an excellence in project management can be

achieved by project management maturity model (PMMM) which is comprised of five levels, as

shown in Figure 1. Each of the five levels represents a different degree of maturity in project

management (Kerzner, 2001; OGC, 2006; Wysocki, 2004; Cleland and Ireland, 2006). These levels,

which can be seen in Figure 2. are (Demir and Kocaba, 2010):

1. Level 1- Common Language (Initial Process): In this level, the organization recognizes the

importance of project management and the need for a good understanding of the basic

knowledge on project management and the accompanying language or terminology. In the

first level, project definition and awareness are important.

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Electronic Records in Healthcare: The Need for Quality Standards 18

2. Level 2- Common Processes (Repeatable Process): In this level, the organization recognizes

that common processes need to be defined and developed such that successes on the project

can be repeated on other projects.

3. Level 3- Singular Methodology (Defined Process): In this level, the organization recognizes

the synergistic effect of combining all corporate methodologies into a singular methodology,

the center of which is project management. The synergistic effects also make process control

easier with a single methodology than with multiple methodologies. of Excellence (COE) role

deployment.

4. Level 4- Benchmarking (Managed Process): This level contains the recognition that process

improvement is necessary to maintain a competitive advantage. Benchmarking must be

performed on a continuous basis. The company must decide whom to benchmark and what to

benchmark.

5. Level 5- Continuous Improvement (Optimized Process): In this level, the organization

evaluates the information obtained through benchmarking and must then decides whether or

not this information will enhance the singular methodology.

.

Figure 2. The five levels of project management maturity (Demir and Kocaba, 2010)

4.4 Implications of Electronic Records in Healthcare

Comparing what has been described concerning the healthcare information systems and quality

standards and cases presented in section 3 we can see that healthcare information systems is still at the

early stages of maturity. Focusing on the main issue addressed in this paper, namely electronic

records in healthcare, it is clear that regarding the eHealthcare architecture maturity model, EHR and

health information repositories, patient path as well as data interchange, interoperability and

accessibility, and clinical terminology and classification are major components of this model (BSI,

2012a). In order to achieve this, it is highly necessary to standardize some basic terminology such as

EHR, as well as other clinical terms in order to achieve interoperability between different systems.

Concerning the CMM(I), electronic records in healthcare are still at an early stage of maturity, due to

lack of standardization. Other relevant models such that of Garzás et al. (2013) focus on stakeholder

requirement as well as systems requirements, which in our case is necessary for the design of the

system. Thus patient centered design is an issue here, which requires flexibility due to different

patient’s needs. For the sake of patient safety, an auditing process such as that suggested by Garzás et

al. (2013) is needed.

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Level 1 of the project management maturity model focusing on common language emphasizes what

has been recommended above concerning standardization of basic terms.

5 CASE FINDINGS

As mentioned, the aim of this research is to investigate the issue of standardization of electronic

records in healthcare. The research is willing to investigate whether there are specific standards being

followed in this context to facilitate the shareability and interoperability concerning patient data. As

has been seen from the literature and popular quality standards, even some terms do not mean the

same thing to different researchers or stakeholders. There is another important question here, namely

can we reach this standardization? One of the relevant matters here is the patient centric view, which

has shown through the literature, is that each patient is a different case, due to multiple factors, which

are not just limited to the disease, which by itself can change over time. This matter may limit the

standardization issue.

5.1 Research Method

In order to perform this investigation, the research method that has been selected is the case study

research method. This is because it enables in depth investigation required for such a study. Further,

the specific type of case study is exploratory. This type of case study is used to explore those

situations in which the intervention being evaluated has no clear, single set of outcomes (Yin, 2003).

In the context of this research a qualitative approach is more appropriate as such approach can be used

to: (a) investigate little-known (b) examine in depth complex processes; (c) examine the phenomenon

in its natural setting and, (d) learn from practice. In doing so, various data collection methods such as

interviews and documentation were used. This study includes embedded units of analysis. Thus,

separate in depth interviews have been conducted from both medical specialists as well as the IT side.

The analysis technique utilised in this research is pattern matching. The bias that is considered to be a

danger in using qualitative research approach is overcome in this research by data triangulation.

5.2 Case Description and Results

The case under investigation is one of popular centers in the United States. It incorporates multiple

networks of centers in different specializations one if which is its cancer center, which is nationally

recognized for quality, with accreditations from the American College of Surgeons Commission on

Cancer, National Accreditation Program for Breast Centers (NAPBC) and American College of

Radiology for our Breast Imaging Center of Excellence. With the opening of their new Cancer

Resource and Support Center (CRSC), patients at risk for cancer, the newly diagnosed patient, those in

treatment and those in survivorship have the availability of a full continuum of services in an

environment of patient comfort and dignity. Among the services offered are: American Cancer

Society-trained cancer resource volunteers to provide educational information and guidance, new

patient orientation classes, nurse navigators, financial navigator, genetic counselor, survivorship nurse

practitioner, registered dietitian, integrated therapy, support groups and community forums. Patients

have access to a broad array of clinical research trials in the country. Their multi-disciplinary team of

cancer specialists meets weekly to coordinate the most appropriate treatment plan, which is

individualized to meet the physical, mental and spiritual needs of the patients, their families and the

community.

The medical centers under investigation do not use in-house development, but like most of others they

rely on vendor dependant software. These are CERNER and EPIC EPR vendors, However when

describing what they perform with such software, it is more like BSI EHR definition rather than EPR.

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Electronic Records in Healthcare: The Need for Quality Standards 20

While developing such packages, most of the USA vendors in general do not rely on patient centred

development, or even the practitioners want. However, lately due to multiple Governmental initiatives,

the software providers are starting to have some focus groups which might be including some

specialists. In general, we cannot consider that such applications have reached an advanced level of

maturity, because of the reason that has just been mentioned, and the matter that it lacks a degree of

in-house development that allows appropriate stakeholder analysis.

Investigating the suggested American Standard patient record contents discussed above with the

medical party, has shown that the suggested fields are useful, but they need additional fields to be

added including for example legal document consent, mental status, neurological (physical exam),

extremities, abdomen, previous treatment. It has been clear through the discussion that a due to the

disease nature some specific fields are necessary. One other challenge concerning the standardization,

is that the procedures might be different from a medical center to another. Electronic records for

patients are vital, as they have been facing situations, where the diagnosis and consequently the

treatment has not been as desired due to the matter that the patient does not remember to mention

some important issue to the specialist such as some side effects they had from some medication, a

previous disease or a medical process they went through. So although the challenges of

standardization it is important to share the patient records and history. When sharing the patient record

with other medical centers, a hard-copy subject to patient consent and signature can be provided.

It has been confirmed that the focus of the American Government aims to promote standardization and

patient safety. An example is the Medicare or Medicaid Electronic Health Record (EHR) Incentive

Program mentioned above. The American Recovery and Reinvestment Act of 2009 (ARRA) provides

incentive payments for Medicare and Medicaid providers who “adopt, implement, upgrade, or

meaningfully use [MU] certified electronic health records (EHR) technology.” Further, the main

focus of the and the integrated medical centers under investigation in this case, is patient safety and

interoperability development efforts rather than patient centric development. There is a fear of

developing web applications allowing the patient accessibility to the medical data without an

intermediary, who need to be a medical party to perform proper explanation of the results. The current

systems used provide a degree of standardization with some degree of flexibility to allow customizing

patient data.

In order to understand who exactly a patient from their perspective and thus requires to have a record,

it has been confirmed that a patient is one who visits the center with a complaint, or someone who is

doing regular check-up, or those who are under management. Clearly, each of those categories needs

different types of support where specific data is required incorporating multiple processes, which adds

to the complexity of healthcare. Although that the data gathered in the first visit for all categories is

almost the same (management phase) but thereafter changes happen depending on the case (follow

up), which means that the patient status might change from a status to another. This will require new

management methods for the patient. On one hand, once a patient has been registered, the relationship

with the primary care usually doesn’t end; on the other hand the relationship with specialists might

end. This means that the patient status is never static, and might change its status over time,

especially that the treatment process may trigger side effects or even secondary disease. Further, the

main disease of the patient might be cured and the major case would be related to another specialist, so

this means that shareability of patient records are vitally required. As each patient might be seeing

more than one specialist especially due to the complications of the cancer therapy, data can be shared

between medical stakeholders as hardcopies (lack if electronic integration is due to privacy issues),

where the patient consent is mandatory. This is considered as one of the challenges of integration. A

patient may suffer from multiple diseases, which can be classified as primary, secondary, surgical, and

diagnosis.

Although that the importance issue of patient centricity and healthcare information systems

development, which is adds to the complexity of healthcare information systems multiple issues that

have been referred to in the literature have been confirmed, the patient centric view is not the highest

priority as safety. As a starting point, it has been confirmed from the medical specialist’s point of view

that technology in healthcare can kill, which means that safety should be the number one priority for

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Electronic Records in Healthcare: The Need for Quality Standards 21

any technology used for processes of care. This can occur with computer assisted radiation devices, or

unreliable patient records, as examples. However, it has been agreed that multiple issues are important

to understand concerning each individual patient case. Diversity includes all aspects of culture, as well

as socioeconomic status, religion, disability, age, gender, race, environment etc.

6 CONCLUSIONS

This paper has investigated the issue of standardization of electronic records in healthcare. The

research is willing to investigate whether there are specific standards being followed in this context

to facilitate the shareability and interoperability concerning patient data. As has been seen from the

literature that although a great effort has been performed from some quality standards institutions

such as British standards and ISO some terms do not mean the same thing to different researchers

or stakeholders. Although the dynamic nature of patients and that that each patient is a specific

case, which may require different data fields to be stored, there are basic fields that need to be

standardized, especially concerning each disease category. This needs to be supported by a degree

of flexibility of the system to change the patient status in an ongoing manner. Unless a degree of

basic standardization is reached, the healthcare information systems will remain in a primitive

maturity level. We understand that such a degree of lack of standardization to the patient and the

environment will remain. This paper concludes to that there is a need to suggest a maturity model

for electronic records in healthcare information systems and achieve an appropriate balance

between standardization and flexibility. This requires transdisciplinary integration efforts from

practitioners, patients, quality standards organizations, governments, WHO and others to identify

such standards and vocabulary preferably classifying according to disease or at least medical

specialization. An integrated maturity model for electronic records in healthcare information

systems including but not, limited to project management, infrastructure, and architecture need to

be developed. For the sake of patient safety, auditing is an important matter that needs to be

considered in such a model.

7 ACKNOWLEDGMENT

The author would like to thank Prof. Ray J Paul Emeritus Professor at Brunel University for the

continuous discussions and collaboration in the area of healthcare information systems. This includes

multiple topics including electronic records in healthcare; which is an ongoing issue in our

collaboration and we are working on another paper on this topic to appear fairly soon.

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