Monday, April 16, 2012

NEHTA Is Really Being Called On Its Efforts In Patient Safety. Even From Their Clinical Lead!

The following appeared this morning.

Concern for patient safety with e-records

Mark Metherell
April 16, 2012 - 12:07AM
PATIENT safety under the proposed electronic health records system cannot be guaranteed less than three months before it is scheduled to start.
Safeguards to prevent and correct snafus with doctors' software, such as medication mistakes, have yet to be provided for in the national e-health scheme beginning on July 1.
The warning has come from three experts, including Mukesh Haikerwal, chief clinical adviser to the e-health transition agency.
They warn that the lack of a national clinical safety system to deal with glitches in doctors' desktop computers and electronic devices such as iPhones and iPads means that "it is not yet possible to make any definitive statement about whether the personally controlled electronic health record is safe or not".
"There is no guarantee that harm events will be rapidly identified or remediated when it is in operation," they write in an editorial, published in the Medical Journal of Australia today.
Their warning is the latest challenge to confront the e-health plan, which has attracted growing criticism about security and privacy concerns spurred by the uncertain performance of the body responsible for the e-health rollout, the National e-Health Transition Agency.
Lots more here:
The original paper is here:

A call for national e-health clinical safety governance

Enrico W Coiera, Michael R Kidd and Mukesh C Haikerwal
Med J Aust 2012; 196 (7): 430-431.
doi:  10.5694/mja12.10475
The benefits of technology should not be overshadowed by avoidable patient harm
Sadly this paper is behind a paywall so it won’t get the full coverage it deserves. Here are the principles is recommends. (Prof Coiera has just let me know anyone who wants a copy can e-mail him to obtain a copy. He is findable via UNSW)

Principles for national e-health clinical safety governance

  •  E-health clinical safety governance must be national but independent of government or industry, to avoid conflicting interests that may lead to resisting change for commercial, professional or political reasons. It must be expert-based rather than organisationally representative.
  • Safety is an emergent property of a whole system. Certification of individual components does not guarantee that the whole system is safe.
  • E-health clinical safety governance should integrate with mainstream patient-safety processes. Harms arise from sequences of events involving both technical and non-technical elements.
  • Governance must assure all components are safe, both alone and in combination with pre-existing elements. Standards and regulatory processes such as accreditation should underpin this, with full legislative backing.
  • The safety of the whole system must be monitored in routine use to detect potential risks and actual harm events, as well as clusters. Open disclosure should be paramount.
  • Governance must build defences against harm, including safety processes, system redundancies and training, to minimise unsafe use or the creation of unsafe settings.
  •  Any governance body must have a capability to investigate, analyse and act upon significant risks in the system.
I have to say it would be hard to argue with any of those. How many of these do you see NEHTA following at present?
They are in pretend mode as far as I can tell. Their heads are planted firmly in the sand.
Again we see the lack of leadership and governance in the Australian e-Health effort is being seen for what it is - utterly inadequate.
More evidence on all this over the next few days.


Anonymous said...

E-health clinical safety governance must be national but independent of government or industry, to avoid conflicting interests ? ? ? ? ? ?


And exactly how would THEY manage the conflict of interest that would emerge through influence of a supposedly independent monitoring body ? ? ? ? ? ?

Dr David More MB PhD FACHI said...

Presumably the governance would be provided by health experts, academics and industry experts who have no direct interest.

Remember we would want the governance mechanism to have an powerful influence on what HIT providers and Government do.


Enrico Coiera said...

This is how they do it in the airline industry:

"The Civil Aviation Safety Authority (CASA) was established on 6 July 1995 as an independent statutory authority. Under section 8 of the, Civil Aviation Act 1988, CASA is a body corporate separate from the Commonwealth."

Anonymous said...

E-health clinical safety governance must be national but independent of government or industry, to avoid conflicting interests ? ? ? ? ? ?

Where is clinical safety in conflict with government? There is higher probability of conflict from commercial and private interests. They would seek to put their own influencers in independent authority positions.

Enrico Coiera said...

"Where is clinical safety in conflict with government? "

When government is both the service provider and the regulator of that service, it has a direct conflict of interest. In such circumstances, it makes sense to set the regulator up to be independent of government.

Each country will need to find its own balance in this, given the varying mix of public/private service provision, and approach to regulation we see around the world.

In Australia, it makes sense to look to the most successful local models, to see what works best for us. THe CASA example for the airline industry suggests government can successfully set up an independent regulator.

The more independent the regulator, the better for government if it is a service provider. This is because a clan 'bill of health' by an independent regulator will give the community confidence in the system. If they are suspicious of the regulator's independence it can be the kiss of death for the service - politics being what is is.

Industry also benefits in the sense that if it passes the regulator's standards it is given a degree of protection should patient harm events occur - as they will from time to time - despite best efforts.