assignment 1

Received: 13 March 2015

Revised: 26 August 2015

Accepted: 24 November 2015

Cite this article as: Schultz TJ, Hannaford N, Mandel C. Patient safety problems from healthcare information technology in medical imaging. BJR Case Rep 2016; 2: 20150107.

TECHNICAL NOTE

Patient safety problems from healthcare information technology in medical imaging 1,2 TIMOTHY J SCHULTZ, BSc (Hons), PhD,

1,2 NATALIE HANNAFORD, RN, MPH and

3,4 CATHERINE MANDEL, MBBS, FRANZCR

1 Australian Patient Safety Foundation, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, SA, Australia 2 School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, SA, Australia

3 Brain and Psychological Sciences Centre, Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne,

VIC, Australia 4 Department of Radiology, University of Melbourne, Melbourne, VIC, Australia

Address correspondence to: Dr Timothy J Schultz

E-mail: [email protected]

ABSTRACT

Health information technology (HIT) systems have been deployed extensively by healthcare organizations and promoted

as a panacea to many of the challenges faced by medical imaging departments, particularly with respect to workflow,

efficiency and diagnostic accuracy. This report describes how inadequate planning, integration, training and testing of

HIT can impact on patient safety and result in patient harm.

INTRODUCTION Health information technology (HIT) has been defined as:

“hardware or software that is used to electronically create,

maintain, analyse, store, receive (information), or otherwise

aid in the diagnosis, cure, mitigation, treatment or

prevention of disease and that it is not an integral part of (1)

an implantable device or (2) medical equipment”. 1

HIT systems, particularly those used in radiology such as clinical decision support, picture archiving systems (PACS) and radiology information systems, are commonly pro- moted as the solution to many of the challenges faced by radiology departments.

2 Radiologists, radiographers and

referrers now rely on them to aid the diagnosis and treat- ment of patients. While there is some evidence for the clin- ical and operational benefits of such systems,

3 there is

growing evidence that PACS and similar systems are capa-

ble of harming patients. 4

This case (Box 1) is a HIT incident recently reported into the Radiology Events Register (RaER; www.raer.org. au). This is a voluntary, anonymous, radiology-led inci- dent reporting system in use in Australia and New Zea- land that was developed to inform quality improvement initiatives in radiology.

5,6 Other avenues exist for clini-

cian-reported information about patient safety, including hospital-based reporting systems, and external regulatory or legal agencies whose primary roles are to ensure pub- lic accountability.

7 However, anonymous and blame-free

reporting using a quick and easy system that provides

feedback and can lead to system improvement will max- imize opportunities to learn from adverse events and “near misses”.

8,9 Identifying information collected by

RaER is protected from disclosure under statutory

immunity legislation. 6 However, even in optimal report-

ing systems, the barriers to incident reporting are signif- icant, particularly for doctors.

10 Enhancing engagement

with doctors, targeted incident reporting, and effective triaging and robust analysis are essential for the success of incident reporting system’s raison d’être of improving the safety of healthcare.

11 Although incident reporting

systems are a good way of detecting safety issues and trends and alerting others to issues, they cannot, as non-mandatory systems, provide reliable information on the incidence of events.

7

DISCUSSION Despite widespread and enthusiastic uptake in many quarters, a large review of the impact of HIT on patient safety in 2012 reported “mixed” evidence.

12 A summary

of very recent evidence, however, stated that the quality and safety of healthcare has been clearly improved by HIT, but

“research should now turn to understanding the relatively

small but important number of unintended consequences

…especially in areas that impact patient safety”. 13

This finding supports a 2013 US poll of safety, quality improvement and healthcare administration leaders, which

BJR|case reports doi: 10.1259/bjrcr.20150107

© 2015 The Authors. Published by the British Institute of Radiology. This is an open access article under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.

identified HIT safety as the hazard of greatest concern. 14

The case presented here demonstrates how one HIT error can have numerous potential adverse outcomes for many patients and how a concerted effort is required to ensure the reliability of HIT systems to acquire, store and support radiologist interpreta-

tion and reporting of images and the distribution of reports. Although the outcomes reported in the case were not specific, other studies have provided examples of actual patient harm from similar errors. For example, in a study of 46 HIT events in which patients were harmed, computerized physician order entry and PACS were involved in 93% of cases.

15 In one

instance, a patient died when a network problem in the PACS delayed transmission of images to a remote site for diagnosis, and in another example, the failure of a system to produce reports following a software upgrade was associated with a patient missing out on a liver transplant.

15

Medical practitioners are given minimal training on the use and operation of HIT systems (personal observations), reflect- ing a wider lack of appropriate skills assessment and training in HIT skills in the healthcare setting.

16 Training should

therefore be built into any HIT vendor contract, and protected radiologist time for initial training should be built into the radiologist’s schedule.

17 Learning curves will vary between

users——for example, part-time staff may require more train- ing, and ongoing systems training may be required for new

radiologists or to update skills and after major upgrades. 17

Large departments should plan for decreased productivity dur- ing rollout of a new system, and should consider employing full-time on-site vendor application specialist or providing in- house training.

17 Developing radiologist and radiographer

“super-users” with specialist knowledge who will share this knowledge with others should also be considered.

16,17 The lack

of training can result in less ability to use the technology opti- mally and decreased satisfaction on the part of the users who may struggle with the systems.

System flaws or issues identified with HIT updates or integration should be addressed by appropriate personnel in a timely man- ner using principles of system resilience and high reliability organizations.

9 Creating resilient systems means ensuring that

the same types of errors are not repeated, and HITs must be redesigned to reduce our dependence on vigilant practitioners and auditing processes to detect and prevent patient harm.

4

Reliable systems to identify and fix HIT problems decrease healthcare practitioners’ stress and dissatisfaction, especially if

the errors increase the risk of harming patients.

One of the primary goals of a PACS system is to increase the availability and timeliness of results at multiple locations to numerous providers and referrers. This goal can be severely hin- dered when data availability errors or “crashes” occur. These can be from unexpected downtime owing to an upgrade as in the case study presented, interoperability failures, lack of access to electronic medical records, failures related to being able to access previous radiology reports and studies,

2 and integration or fire-

wall issues. All of them can result in delayed diagnosis and treat- ment and potential harm to patients, and increased risks of litigation. As shown in the case, radiologists were required to work late to address the problem, and such ameliorating actions could conceivably impact on their satisfaction in the workplace. We could find no published research on the recommended fre- quency of upgrades to PACS.

Based on a systems approach to human error, 9 PACS-specific

data availability errors 4 and an emerging evidence base on HIT

impacts on patient safety in medical imaging, 15–18

we propose the following 11 strategies that may be beneficial as a starting point in minimizing the risk of patient harm from problems with radiology HIT (Box 2). The 11 proposed strategies are grouped into five key areas related to: (i) preparation and inte- gration of new systems; (ii) staff training and updates; (iii) appropriate information technology (IT) support; (iv) contin- gency planning to deal with problems; and (v) appropriate con- figuration and communication between systems. These factors should be considered at the time of design and purchase of sys-

tems, and should be supported by the availability of well-trained, dedicated IT staff to manage HIT systems. The ubiquity of HIT in current radiology practice demands a greater focus from all stakeholders, in particular: radiologists; practice, quality and/or departmental managers; accreditors; and professional organiza- tions who set the standards of practice. For example, what

Box 1. The information technology incident reported to the Radiology Events Register database by an anonymous

user showing responses to the main categories of information collected by the reporting system. As this is an anony-

mous report, it is not possible to ask further questions about the event.

Description of incident: An upgrade to the picture archiving systems (PACS) took longer than expected and resulted

in the loss of functionality in the PACS. The next day it was evident that the images could not be transferred to PACS

patient folders. This resulted in delayed reporting of images that were acquired but not loaded into PACS.

Contributing factors: Unexpected difficulties with the upgrade and lack of situational awareness as to the severity or

impact of this issue and no plan of action being available for dealing with this problem.

Consequence/outcome: Delayed reporting and referrers unable to view images in a timely manner.

Action taken: All radiologists were made aware of the problems and arrangements were made for the radiologists to

work late to report the outstanding studies.

Preventability: Having plans for PACS upgrades with contingency and potential problem action plans and redundancy

capability in place. Ensuring adequate communication of problems across departments, with escalation if problems

are encountered and having PACS health dashboards, alerts and escalation policies and procedures.

Reporter: Radiologist.

BJR|case reports Schultz et al

2 of 4 birpublications.org/bjrcr BJR Case Rep;2:20150107

constitutes: appropriate backup or emergency/contingency plan- ning measures, acceptable downtime in outpatient and inpatient practice, and capacity for printing films. Similar to much of HIT, the evidence base to guide recommended practice in these areas is still developing. The need for guidance for the radiology

profession is urgent.

CONCLUSION Data availability errors can occur as a result of inadequate planning, unexpected downtime without adequate backup, lack of foresight and, importantly, poor understanding of inte- grating HIT systems into a practice. The general strategies suggested above aim to reduce and manage the risk of HIT

error. Ensuring that individual settings protocols for manag- ing planned and unexpected downtime of HIT systems are fit for purpose and robust is warranted. As there are a multitude of settings, technologies and healthcare systems potentially affected, it is difficult to specify in further detail; however,

further discussion about general HIT issues in medical imag- ing is a good place to start.

Capturing and analyzing radiology incident data helps to

engage doctors in patient safety, identify errors specific to

radiology, work out how they occur and provides an oppor-

tunity to develop and communicate potential preventative

and corrective strategies.

REFERENCES

1. AHRQ Common Formats. Device or

Medical/Surgical Supply, including Health

Information Technology (HIT) 2012.

Available from: https://www.psoppc.org/

web/patientsafety/version-1.2_documents#

Supply

2. Collin S, Reeves BC, Hendy J, Fulop N,

Hutchings A, Priedane E. Implementation

of computerised physician order entry

(CPOE) and picture archiving and

communication systems (PACS) in the

NHS: quantitative before and after study.

BMJ 2008; 337: a939.

3. Nance Jr JW, Meenan C, Nagy PG. The

future of the radiology information system.

AJR Am J Roentgenol 2013; 200: 1064–70.

4. Savoie B, Nagy P. PACS and the

potential for medical errors. J Am Coll

Radiol 2012; 9: 756–8.

5. Jones DN, Benveniste KA, Schultz TJ,

Mandel CJ, Runciman WB.

Establishing national medical imaging

incident reporting systems: issues

and challenges. J Am Coll Radiol

2010; 7: 582–92.

6. Mandel C, Grimm J, Schultz TJ, The

Radiology Events Register (RaER).

HealthManagement.org 2015;

15: 109–14.

7. World Alliance for Patient Safety.

WHO Draft Guidelines for Adverse

Event Reporting and Learning

Systems. Geneva: World Health

Organization; 2005.

8. Anderson JE, Kodate N, Walters R,

Dodds A. Can incident reporting

improve safety? Healthcare practitioners’

views of the effectiveness of incident

reporting. Int J Qual Health Care 2013;

25: 141–50.

9. Reason J. Human error: models and

management. BMJ 2000; 320: 768–70. doi:

10.1136/bmj.320.7237.768

10. Waring JJ. Beyond blame: cultural barriers to

medical incident reporting. Soc Sci Med

2005; 60: 1927–35.

11. Mitchell I, Schuster A, Smith K,

Pronovost P, Wu A. Patient safety incident

Box 2. Strategies to reduce and manage the risk of health information technology (HIT) error.

Preparation and integration for new and upgraded systems

▪ Work with vendors and your organization to ensure appropriate integration of new HITs in your facility.

▪ Harmonize terminology, exposure indicators and information systems when products or versions from multiple

vendors are being used.

▪ Carefully schedule HIT system changes to minimize disruption to normal workload and ensure contingency

plans are in place (see below).

Training for radiologists and radiographers

▪ Train staff prior to the integration of HITs.

▪ Provide staff with training updates as a refresher and following system upgrades.

Appropriate information technology (IT) support

▪ Ensure timely access to designated IT personnel who are sufficiently trained in all aspects of the HITs in use in

your facility.

Contingency planning

▪ Have detailed plans and emergency operation modes for managing unexpected downtimes.

▪ Effectively communicate planned or unplanned outages to all staff and referrers.

▪ Have adequate escalation procedures in place to deal with problems with the potential to cause patient harm.

Configuration and communication between systems

▪ Configure HITs (picture archiving systems/radiology information systems/electronic referral or computerized

physician order entry) so that they are interoperable and communicate with each other.

▪ Ensure access to prior studies——pre-fetching algorithms and display protocols.

Technical note: Patient safety and information technology BJR|case reports

3 of 4 birpublications.org/bjrcr BJR Case Rep;2:20150107

reporting: a qualitative study of thoughts

and perceptions of experts 15 years after ‘To

Err is Human’. BMJ Qual Saf Jul 2015. Epub

ahead of print. doi: 10.1136/bmjqs-2015-

004405

12. Institute of Medicine, A. Health

IT and patient safety: building safer

systems for better care. Washington, DC:

Institute of Medicine; 2012. Available from:

http://www.nap.edu/download.php?

record_id=13269

13. Banger A, Graber ML. Recent evidence that

health IT improves patient safety. Research

Triangle Park, NC: RTI International; 2015.

Available from: https://www.healthit.gov/

sites/default/files/brief_1_final_feb11t.pdf

14. Denham CR, Classen DC, Swenson SJ,

Henderson MJ, Zeltner T, Bates DW.

Safe use of electronic health records and

health information technology systems.

J Patient Saf 2013; 9: 177–89.

15. Magrabi F, Ong MS, Runciman W,

Coiera E. Patient safety problems

associated with heathcare information

technology: an analysis of adverse

events reported to the US food and drug

administration. AMIA Annu Symp Proc

2011; 2011: 853–7.

16. Watson L, Odle TG. The technologist's role

in patient safety and quality in medical

imaging. Radiol Technol 2013; 84: 536–41.

17. Weiss DL, Kim W, Branstetter BF 4th,

Prevedello LM. Radiology reporting: a

closed-loop cycle from order entry to results

communication. J Am Coll Radiol 2014; 11:

1226–37.

18. Georgiou A, Lymer S, Forster M, Strachan

M, Graham S, Hirst G, et al. Lessons learned

from the introduction of an electronic safety

net to enhance test result management in an

Australian mothers’ hospital. J Am Med

Inform Assoc 2014; 21: 1104–8.

BJR|case reports Schultz et al

4 of 4 birpublications.org/bjrcr BJR Case Rep;2:20150107