TestSafe – the Auckland Regional Clinical Data Repository Striking a balance between accessibility and confidentiality of clinical information Ross Boswell Middlemore Hospital [email_address]

Ross Boswell

Middlemore Hospital

[email_address]

Middlemore Hospital

Counties-Manukau District Health Board University teaching hospital complex 450,000 population served 850 inpatient beds 350,000 annual outpatient attendances 400 (250FTE) general practitioners

University teaching hospital complex

450,000 population served

850 inpatient beds

350,000 annual outpatient attendances

400 (250FTE) general practitioners

Medical Records - Storage

The New Way ECLAIR E LECTRONIC CL INIC A L I NFORMATION R EPOSITORY Developed in partnership with Sysmex NZ Accepts HL7 messages Displays reports Provides cumulative / graphical display Allows printing of reports Provides for report acceptance (sign-off)‏ Provides for report annotation and referral Maintains an open audit trail

ECLAIR

E LECTRONIC CL INIC A L I NFORMATION R EPOSITORY

Developed in partnership with Sysmex NZ

Accepts HL7 messages

Displays reports

Provides cumulative / graphical display

Allows printing of reports

Provides for report acceptance (sign-off)‏

Provides for report annotation and referral

Maintains an open audit trail

Standards Primary Patient Identifier National Health Index [ ABC1234 ] Standard Messaging Protocol (HL7)‏ NZ adoption of HL7 v2.1 (1993)‏ Most recent version v2.4 LOINC (Logical Observation Identifiers, Names & Codes)‏ Observation, organism and procedure coding

Primary Patient Identifier

National Health Index [ ABC1234 ]

Standard Messaging Protocol

(HL7)‏

NZ adoption of HL7 v2.1 (1993)‏

Most recent version v2.4

LOINC

(Logical Observation Identifiers, Names & Codes)‏

Observation, organism and procedure coding

Initial Business Rules Security Report access Printing

Security

Report access

Printing

Security No generic usercodes Policy on electronic identity User privileges by class of user Usercode expiry date [ Password expiry date forcing password change ]

No generic usercodes

Policy on electronic identity

User privileges by class of user

Usercode expiry date

[ Password expiry date forcing password change ]

Report Access Strong identifier - National Health Index Name search enquiry disallowed All results available to accredited users (no hidden or confidential results)‏ Interim / unauthorised / final / amended reports (non-repudiation)‏

Strong identifier - National Health Index

Name search enquiry disallowed

All results available to accredited users (no hidden or confidential results)‏

Interim / unauthorised / final / amended reports (non-repudiation)‏

Printing Option to print from Eclair with no restrictions (decentralised printing) All printed reports will be shredded No Eclair paper reports are permanently filed in casenotes

Option to print from Eclair with no restrictions (decentralised printing)

All printed reports will be shredded No Eclair paper reports are permanently filed in casenotes

Eclair Repository Timeline Installed for Middlemore Hospital 1997 “ Paperless” lab reporting 1999

Installed for Middlemore Hospital 1997

“ Paperless” lab reporting 1999

Auckland Regional District Health Boards Three university teaching hospital complexes 1,400,000 population served 2600 inpatient beds >1M annual outpatient attendances 1200 (800FTE) general practitioners

Three university teaching hospital complexes

1,400,000 population served

2600 inpatient beds

>1M annual outpatient attendances

1200 (800FTE) general practitioners

Eclair Repository Timeline I nstalled for Middlemore Hospital 1997 “ Paperless” lab reporting 1999 North Shore Hospital joined 2002 “ Paperless” lab reporting 2003 Auckland Hospital joined 2003 “Paperless” inpatient lab reporting 2004

I nstalled for Middlemore Hospital 1997

“ Paperless” lab reporting 1999

North Shore Hospital joined 2002

“ Paperless” lab reporting 2003

Auckland Hospital joined 2003 “Paperless” inpatient lab reporting 2004

Eclair Repository Timeline I nstalled for Middlemore Hospital 1997 “ Paperless” lab reporting 1999 North Shore Hospital joined 2002 “ Paperless” lab reporting 2003 Auckland Hospital joined 2003 “Paperless” inpatient lab reporting 2004 Auckland Regional Primary Care results from June 2006 – TestSafe branding Auckland Regional Primary Care provider access from September 2007

I nstalled for Middlemore Hospital 1997

“ Paperless” lab reporting 1999

North Shore Hospital joined 2002

“ Paperless” lab reporting 2003

Auckland Hospital joined 2003 “Paperless” inpatient lab reporting 2004

Auckland Regional Primary Care results from June 2006 – TestSafe branding

Auckland Regional Primary Care provider access from September 2007

TestSafe Issues Business Case Capacity Capability Privacy

Business Case

Capacity

Capability

Privacy

TestSafe Business Case Estimated unnecessary repeat testing Audit of Lipids, HbA1c 5% of tests = $7Mpa (30% realisable)‏ Reduced cost Reduced patient inconvenience Clinical safety More complete information Faster decision-making “ The right thing to do”

Estimated unnecessary repeat testing Audit of Lipids, HbA1c 5% of tests = $7Mpa (30% realisable)‏

Reduced cost

Reduced patient inconvenience

Clinical safety

More complete information

Faster decision-making

“ The right thing to do”

TestSafe Capacity Hospital laboratories report about 4M tests per year Community laboratories report about 7M tests per year Database size (Feb 2008) 396GB Growth about 8GB/month Archiving option (not yet adopted)‏

Hospital laboratories report about 4M tests per year

Community laboratories report about 7M tests per year

Database size (Feb 2008) 396GB

Growth about 8GB/month

Archiving option (not yet adopted)‏

TestSafe Capability Oracle Real Application Cluster database on an 8-processor Linux cluster Reports are sent overnight 20,000 -25,000 additional HL7 messages per night Report processing takes about 5 hours No discernable degradation in performance

Oracle Real Application Cluster database on an 8-processor Linux cluster

Reports are sent overnight

20,000 -25,000 additional HL7 messages per night

Report processing takes about 5 hours

No discernable degradation in performance

TestSafe Privacy Patient can “opt off” (0800 LABSAFE) with some limitations Test requestor can “prevent sharing” All use is logged for audit

Patient can “opt off” (0800 LABSAFE) with some limitations

Test requestor can “prevent sharing”

All use is logged for audit

TestSafe Privacy Patient “opt off” Not available when there is no alternative delivery mechanism Opt-off by date or date range Historic opt-off is possible All TestSafe users are unaware of the existence of the suppressed information

Patient “opt off”

Not available when there is no alternative delivery mechanism

Opt-off by date or date range

Historic opt-off is possible

All TestSafe users are unaware of the existence of the suppressed information

TestSafe Privacy Provider (doctor) prevents sharing Request form tick-box was demanded by primary care organisations Provider opt-off for all tests requested at a single episode TestSafe users are unaware of the existence of the episode Some organisations instructed the community laboratory “Never share my patients' results”

Provider (doctor) prevents sharing

Request form tick-box was demanded by primary care organisations

Provider opt-off for all tests requested at a single episode

TestSafe users are unaware of the existence of the episode

Some organisations instructed the community laboratory “Never share my patients' results”

TestSafe Privacy Audit All access is logged and any user can display the audit trail Audit by user fingerprints and by “celebrity” patient Same-surname access reports Break-glass is required where the patient is not registered to the user's facility (60-day rule)‏ Break-glass events are subject to more intense audit

Audit

All access is logged and any user can display the audit trail

Audit by user fingerprints and by “celebrity” patient

Same-surname access reports

Break-glass is required where the patient is not registered to the user's facility (60-day rule)‏

Break-glass events are subject to more intense audit

TestSafe – the first two months 472,332 patients tested ~1M test groups received 7.5% of test groups viewed 2744 provider prevented sharing 7699 provider does not share 3 patients opted off

472,332 patients tested

~1M test groups received

7.5% of test groups viewed

2744 provider prevented sharing

7699 provider does not share

3 patients opted off

TestSafe – the first nine months 567,064 patients tested 4,615,251 test groups received 12% of test groups viewed 4779 provider prevented sharing 56,537 provider does not share 18 patients opted off

567,064 patients tested

4,615,251 test groups received

12% of test groups viewed

4779 provider prevented sharing

56,537 provider does not share

18 patients opted off

TestSafe – the first year 645,606 patients tested 5,940,539 test groups received 15% of test groups viewed ? provider prevented sharing ? provider does not share 22 patients opted off

645,606 patients tested

5,940,539 test groups received

15% of test groups viewed

? provider prevented sharing

? provider does not share

22 patients opted off

TestSafe – Next Steps Computer-based test ordering Investigate the incorporation of dispensing records

Computer-based test ordering

Investigate the incorporation of dispensing records

TestSafe – Next Steps Computer-based test ordering Investigate the incorporation of dispensing records

Computer-based test ordering

Investigate the incorporation of dispensing records

Success Factors “ Bottom-Up” implementation Pre-existing NHI framework Reliability and speed of access Well-defined governance principles Attention to privacy and confidentiality Open audit trail Users are free to print records

“ Bottom-Up” implementation

Pre-existing NHI framework

Reliability and speed of access

Well-defined governance principles

Attention to privacy and confidentiality

Open audit trail

Users are free to print records

Further Information www.ndsa.co.nz/TestSafe www.sysmex.co.nz/Eclair [email_address]

www.ndsa.co.nz/TestSafe

www.sysmex.co.nz/Eclair

[email_address]

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