Presentation (1,6 Mb) - ICMCC

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Presentation (1,6 Mb) - ICMCC

Primium non nocere

Quality management issues

for medical ICT

TNO Prevention and Health, TG

Quality management issues for medical ICT 1


What you are about to learn

• Part I

• What patient safety is

• What affects patient safety

• How to manage patient safety with the use of ICT

• Part II

• How to improve quality of medical ICT with respect to patient

safety

• Proceedings ICMCC 2004:

• A.C.M. Dumay & G. Freriks, “Quality management issues for

medical ICT”

Quality management issues for medical ICT 2


Part I

Patient safety issues

Quality management issues for medical ICT 3


Definitions

• Patient safety is freedom from accidental injury while receiving

healthcare services. The safest healthcare environment is one

where clinical care is measured and managed and desired clinical

outcomes achieved [1].

• Adverse patient incident is any event or circumstance that could

have or did lead to unintended or unexpected harm, loss or

damage. If the incident caused harm, loss or damage then it is

and adverse event [1].

Quality management issues for medical ICT 4


Facts and figures (UK)

• 10% of patients admitted to hospital will be harmed

• 50% of this is considered preventable

• 6% of this is suffer permanent disablity (3 out of 1000)

• 8% will die (4 out of 1000) [1].

• 7-9% of annual cost of healthcare to deal with adverse events

• over M£ 2,000 for prolonged hospital stay

• over M£ 1,000 to deal with hospital acquired infections

• around M£ 500 for claims for clinical negligence

• M£ 3,000 - 5,000 of outstanding claims [1].

Quality management issues for medical ICT 5


Facts and figures (UK)

• Root cause analysis of adverse patient safety events:

• 63% orientation/ training

• 56% communication

• 50% patient assessment process

• 43% physical environment

• 35% information availability

• 28% staff competency/ credentialing

• 26% equipment factors

• 23% staffing levels

• 18% storage/ access issues [2].

Quality management issues for medical ICT 6


Facts and figures (USA)

• 3-38% of hospitalised patients are affected by iatrogenic

injury or illness

• 44,000-98,000 hospital deaths per year

• over 7,000 adverse drug events per year

• over 2,000,000 nonsocomial infections per year

• 10-35% suffer adverse drug events

• M$ 13,000-29,000 estimated annual costs [4,5].

Quality management issues for medical ICT 7


Facts and figures (Australia)

Australia:

• over 500,000 adverse patient safety events per year

• over 10,000 hospital deaths per year [6].

All documented figures:

• estimated from case analyses

• not based on systematic registration.

Quality management issues for medical ICT 8


Facts and figures (The Netherlands)

First estimation by WINAP:

• over 300 kEURO annual costs related to adverse events [9].

Recent study reveals [10]:

• 6.1% of Dutch inhabitants (≥ 18 years) subject to 1.7 times

information transfer error (ITE) annually [1.28 million ITE

with 161.000 persons]

Quality management issues for medical ICT 9


Facts and figures (The Netherlands)

NIPO reveals further:

• 25% of persons were not treated due to lack of information

• 18% were not expected by the physician

• 44% received wrong medication

• 24% received wrong type of surgery or treatment

• Annual costs in excess of 1.5 Billion Euro !

• excluding additional costs of surgery

• including costs of (partial) disability.

Quality management issues for medical ICT 10


Real cases related to medical ICT

• Exchange of blood groups with fatal result

• Bad prescription of medicine due to wrong mouse clicks on

computer screen

• Edifact messages with many errors

• Connected systems using different versions of ICPC classification

code

• Confirmation of data on screen or data in database?

• Violation of legal security of health professional with removal of

patient data upon patient’s request

Quality management issues for medical ICT 11


ICT the risk factor

New elements compared to paper documents:

• Volatility of software, hardware and data

• Data out of context (data + context = information)

• Trust (information + authorisation = trust)

• Blind trust in computers (The computer says …)

• Lack of traceability

• Complexity of validation

ICT to solve problems …

… ICT to cause problems.

Quality management issues for medical ICT 12


ICT the risk factor

Security:

• Confidentiality

• Integrity

• Availability

• Demonstrability

Safety:

• Risks (identification, control,

verification of control

measures)

• Process control (life cycle

management, design criteria

and validation)

• Implementation (integrity,

traceability, validation)

Quality management issues for medical ICT 13


Future cases?

• Unintended use of outdated medical knowledge in protocols

• Uncontrolled software agents processing patient data

• Conflicting code tables in linked information systems

• Decision support systems with unknown/ outdated decision rules

• Identity theft of patient, health professional

• Corruption or destruction of electronic health records by viruses

• Proof of acting after modification of data

• ...

Quality management issues for medical ICT 14


Part II

Quality issues

Quality management issues for medical ICT 15


Quality dimensions

Six dimensions of quality:

• Safety

• Patient centred-customer value and expectations

• Effective-evidence based practices and outcomes

• Timely

• Efficient

• Equitable [7].

Quality management issues for medical ICT 16


Systems approach to patient safety

management

NHS system of internal control:

• Objectives. WHAT do you want to achieve?

• Stakeholders (internal/ external). WHO is involved?

• Outcomes. WHAT do you want specifically?

• Accountability. WHO is responsible for WHAT?

• Processes. HOW to do to produce the outcomes?

• Capability. Resources (human, financial, physical, skills, …)

Quality management issues for medical ICT 17


Systems approach to patient safety

management

• Monitor and review. Continuous improvement of internal

control

• Independent assurance. Internal/ external auditing,

accreditation, certification, regulatory bodies, …

• Communication and consultation. Keep in touch with all

stakeholders any time.

Statement on Internal Control

related to the six dimensions of QUALITY

Quality management issues for medical ICT 18


Essential requirements to medical ICT

• Council Directive 93/42/EEC of 14 June 1993 concerning

medical devices, OJ L169, 12/07/1993 p.0001

• ISO/IEC 60601-1-4 en ISO 14971

• to identify and control risk

• validation and verification

• life cycle maintenance

• ISO 9001 and/ or CMM (Capability Maturity Model)

• software development under quality system

• software validation guidance

• GAMP

• statement of conformance

• Open international standards (ISO, CEN, HL7)

Quality management issues for medical ICT 19


Software quality ISO 9126

User

Requirements

Quality

Parameters

System

Development

Define

Quality

Measures

System

Validation

System Acceptance Test

Quality management issues for medical ICT 20


Software quality systems

• ISO 9126

• specifies quality requirements

• quantification and management

• ISO 9001 together with ISO 9000-3

• guideline for documentation and procedures

• change control, life cycle management

• Capability Maturity Model (CMM)

• Maturity levels

• Key process area’s

• More comprehensive: Spice, ISO-IEC 15504

• guide to process improvement

• guide to users, implementers and auditors

Quality management issues for medical ICT 21


Conclusions

• Software is important for more and more medical devices

• Software is a source for patient safety incidents

• Controlled processes should be used for:

• design and development

• verification and validation

• implementation and changes

• Some quality system should be used

Quality management issues for medical ICT 22


Contact Information

Dr. Adrie C.M. Dumay

Head of Medical Informatics Department

Email ACM.Dumay@pg.tno.nl

TNO Prevention and Health

P.O. Box 2215

2301 CE Leiden

The Netherlands

tel + 31 71 518 1677

fax + 31 71 518 1902

Quality management issues for medical ICT 23

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