Transcript Handout

Usability & Human Factors
Designing for Safety
Lecture c
This material (Comp15_Unit10c) was developed by Columbia University, funded by the Department of Health and Human
Services, Office of the National Coordinator for Health Information Technology under Award Number 1U24OC000003.
Designing for Safety
Learning Objectives
• Design a workflow analysis study (Lecture
c)
• Identify common sources of error
documented in research studies in
medicine (Lecture c)
• Apply principles underlying the design of
healthcare systems for safety (Lecture c)
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
2
Medical Error Reporting
Use of the taxonomy
MAUDE
Classified reporting better than current free text
Current systems may be overly specific to
domain, task
Should allow ID of problems, solutions
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
3
Koppel – Patient Safety
Sociologist, studying work in hospitals
CPOE is a major source of errors
Sociological causes of errors:
• Vendors sell early (investment makes it less likely hospital will switch)
• Less incentive to be responsive, make changes, feedback/adjustments
Hospital administration:
• Validate investment
• Little incentive to discuss errors
Contracts may prohibit open discussion
Joint Commission rules: hospital and its clinicians are prohibited from not talking about patient safetyrelated errors in relation to HIT
Impossible to tell how system will work in situ until deployment
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
4
Koppel
Example of interface-created error:
• “The impossibility of entering allergies, or when you enter an
allergy, it wipes out the previous allergy. So if the first allergy was
anaphylactic shock and the second was a mild rash to latex,
anaphylaxis dies, disappears, and you get the mild rash to latex
coming up”.
Inability to talk, screenshots ->vendor in control of
information, chooses which flaws to remedy
Realistic testing scenarios rarely used in
purchasing, but should be standard
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
5
Koppel –
Study of Workaround to Barcode
Medication Administration
BCMAs intended to ensure 5 rights:
• Patient
• Drug
• Dose
• Route
• Time
Observation, interviews, failure analyses, log data
at 5 hospitals
Found overrides 4.2% of patients, 10.3% of
medications
Possible consequences:
• wrong admin, doses, times, formulations
Need for attention to in-situ use to ensure safety
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
6
Koppel – (cont.)
Medication administration stage 26-32% of adult
med errors; 4 – 60% pediatric errors
Less likely to be intercepted
Barcode systems: integrate MAR with admin
process, ensure protocols followed
Workarounds: omission of process steps (e.g.
omit visual check of med list, name, dose)
Steps out of sequence (e.g. document before
admin)
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
7
Koppel – Medication Workarounds
(cont.)
Unauthorized BCMA process steps (e.g. barcode
placed on another object, not patient) and scanned
Alert overrides: cause due to smudged/torn
medication label, wristband missing, different dose;
alert confirming scan does not match med order or
patient ID
Causes: technology-related, e.g. software or
hardware problems
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
8
Probable Causes of Workarounds
(Koppel)
Causes:
Task-related: user unfamiliar with protocols, believe it slows performance, e.g.
several patients’ meds on one tray
Organizational: policies incompatible with safety, e.g. patients or meds without
barcodes, codes covered by label, pharmacy sending partial doses.
Patient-related: e.g. refusal, vomiting, sleeping, agitated, central lines, contact
isolation, home-bought meds without barcodes
Environmental: e.g. lack of wireless BCMA, room or doorway hinder bedside
access of BCMA, meds stored remote from scanner (e.g. in fridge) require
trips, loud noise may prevent hearing alarms
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
9
Prevention of Errors From
Workarounds
Key to impact is the multiplicity of relationships: many causes, each causing many
workarounds
Most due to time-saving efforts
Staffing inadequacy
Best done study of system design, workflow integration, integration improvements
Make easier to follow correct procedures, harder to workaround
Not obscure, rare, or secret
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
10
Koppel – JAMA 2005 – Role of
CPOE in Facilitating Errors
Widely discussed mixed methods study of house staff CPOE at
tertiary-care hospital 2002-2004; older system
CPOE facilitated 22 types of med error risks
Fragmented displays, misinterpretations, function separation->dosing
errors, incompatible orders, inflexible order formats-> wrong orders.
75% of house staff report observing these, weekly error risks
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
11
Walker - 2008
Interim, pragmatic framework for assuring EHR safety
Use EHR as tool for process improvement
Requires new organizational policies, processes, work
systems, job descriptions, education
Explicitly recognize safety as a goal
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
12
Walker (cont.)
Reporting to national clearinghouse
For reporting and viewing other institutions’ data in anonymized form
Vendors likewise required to report
Rapid notification to multiple stakeholders when significant flaws/incidents identified
Currently informal listserves
http://www.healthcomputing.com/Klas/Site/
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
13
Recommended
Prevention/Management
Strategies
Local implementation teams should notify EHR vendor
Vendor provides software enhancement
If not, organization changes process or policy
If not, organization removes function from EHR
If not, users warned during training (and if necessary, repeatedly in practice)
Organizations track mitigation efforts, incidents
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
14
Prevention (cont.)
2 teams: shadow trainers observe users, answer questions, JIT education,
report flaws to 24-hour command center
Command center makes rapid fixes, communicates them to users
2nd team: clinical ops leaders, EHR support, informaticians, security, patient
safety, risk management, PR
Meet on few hours notice to correct, warn users, remove flaw from system
Vendors could provide incident management for smaller orgs.
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
15
Canada – Health Infoway
https://www2.infoway-inforoute.ca/Documents/EHR-Patient%20Safety%20Report.pdf
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
16
Problem – Lack of Knowledge
Large scale
studies not
done due to
lack of concept,
technology
standardization
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Largely
anecdotal,
often
confidential
reports
Lack of
measurement,
pre, post
Usability & Human Factors
Designing for Safety
Lecture c
Canada:
jurisdictional
differences
17
Design Patterns and New Methods
Formulate library of design patterns addressing common or identified problems
(e.g. similar drug names)
Dedicated HIT labs attached to hospitals
Invite the participation of a broad base of end-users (e.g. via web 2.0)
• (a) Users may submit “bad” designs and “good” designs
• (b) Users may vote for design candidates to elect the ones that make make most
sense to their work
Simulation/gaming exercises (e.g. OR virtual game for team coordination)
Sandboxes for users
Permit free discussion
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
18
Bad Informatics Examples and
Solutions
The VA's medical data -- vital signs, lab results, active meds -sometimes popped up under another patient's name
Failed to clearly display a doctor's stop order for a treatment,
leading to reported cases of unnecessary doses of intravenous
drugs such as blood-thinning heparin
Baby boy died after an untrained doctor pressed the wrong button
on his bypass machine because it was a less "horrid" color – doctor
did not know correct button
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
19
Multiple Name Formats
J N Tobias
J Noel Tobias
J Tobias
JNTobias
Jonah N Tobias
Jonah Noel Tobias
Jonah Tobias
JonahNTobias
JTobias
Tobias J
Tobias J N
1.1 Table: Senathirajah, Y. (2010).
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Tobias, J
Tobias, J N
Tobias, J Noel
Tobias, Jonah
Tobias, Jonah N
Tobias, Jonah Noel
TobiasJ
TobiasJN
Tobias J N
TobiasJonahN
TobiasJonahNoel
Usability & Human Factors
Designing for Safety
Lecture c
20
Methods of Preventing Error – Tall
Man Lettering
Senathirajah, Y. (2010).
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
21
Regulation?
Food and Drug Authority
(FDA), which regulates
medical devices of all sorts,
has started to look at EHRs
from a product-safety
standpoint
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Current ONC regs mandate
functionality, not safety
standards
Usability & Human Factors
Designing for Safety
Lecture c
22
Designing for Safety
Summary
Designing for safety in healthcare
IT is a difficult, ongoing, and
rapidly changing process in which
research and careful planning are
required.
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
23
Resources
National and International HF Standards applicable to HF
Medical Devices
• ANSI/AAMI/ISO 14971:2001 Risk Management
• ANSI/AAMI HE74: 2001, Human factors design
process for medical devices
• ANSI/AAMI HE75: 2010, Human factors design
principles for medical devices (in progress)
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
24
Designing for Safety
References – Lecture c
Reference
1. Zhang, J., Patel, L.V., Johnson, R. T., &. Shortliffe, H.E. (2004). A cognitive taxonomy of medical errors. Journal
of Biomedical Informatics 37:193–204
2. Koppel, R., and Kreda, K. (2009). Health Care Information Technology Vendors’ “Hold Harmless” Clause:
implications for patients and clinicians., JAMA.2009; 301:1276-1278.
3. Koppel, R., Metlay, J.P., Cohen, A., et. al. (2005). Role of computerized physician order entry systems in
facilitating medication errors. JAMA. 2005;293:1197-1203.
4. Koppel, R. (2010). EMR entry error: not so benign. AHRQ Morbidity and Mortality Rounds on the Web. Case &
Commentary: Medicine, April 2010. Available at http://www.webmm.ahrq.gov/case.aspx?caseID=199
5. Koppel, R. (2008). Wetterneck T, Telles JL, Karsh BT. Workarounds to barcode medication administration
systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc. 2008 JulAug;15(4):408-23.
6. Koppel, R., Metlay, J.P., Cohen, A., Abaluck, B., Localio, A.R., Kimmel, S.E., et. al. (2005). Role of computerized
physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203.
7. Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human. Committee on Quality of Healthcare in America
Institute of Medicine. Washington, DC: National Academy Press; 1999.
8. Walker, J.M., Carayon, P., Levesond. N., Paulus, R.A., Tookere, J., Chin, H., Bothe, A. Jr., Stewart, W.F. (2008).
Perspectives on Informatics EHR Safety: The Way Forward to Safe and Effective Systems. JAMIA 2008
9. Interview with Ross Koppel http://histalk2.com/2009/08/12/histalk-interviews-ross-koppel/
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
25
Designing for Safety
References – Lecture c
Images
Slide 16: Electronic Health Records and Patient Safety A joint report on Future Directions for Canada. Canada Health
Infoway. Retrieved on September 8th, 2010 from
https://www2.infoway-inforoute.ca/Documents/EHR-Patient%20Safety%20Report.pdf
Slide 21: Senathirajah, Y. (2010). Department of Biomedical Informatics, Columbia University Medical Center, New
York, NY.
Charts, Tables & Figures
1.1 Table: Senathirajah, Y. (2010). Department of Biomedical Informatics, Columbia University Medical Center, New
York, NY.
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Usability & Human Factors
Designing for Safety
Lecture c
26