The following report comes from the FDA Maude (Manufacturer and User Facility Device Experience) voluntary-reporting database, reported by a (likely unhappy) biomedical engineer a month after the "incident" - the nature of which is deliberately kept hidden. This is regarding the PICIS "Pulsecheck" EHR for emergency departments:
Report Date 05/14/2010
PICIS INC. CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA
Event Type: Other
Patient Outcome: Required Intervention
Event Description
The customer has reported a patient incident that has prompted a review of their internal process and possible issues surrounding the incident. The customer report alleges the involvement of picis' ed (emergency dept. ) electronic health record application, whereby, duplicate results were received by the picis ehr application from an enterprise info system, which, when displayed in their entirety may have contributed to some degree of confusion for the treating physician - the context of which the customer has declined to clarify any further. [What in the world? -ed.] At this time, we have been informed by the customer that they are restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support picis' investigation.
"Restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support Picis' investigation?"
That is perverse on its face, and probably in violation of Joint Commission safety standards on reporting of incidents that could affect other organizations.
Manufacturer Narrative
Picis' investigation into the reported incident is based on a limited exchange of info with the customer, as well as our internal review of the application design and current configuration in use at the reporting site. Review of configuration files, existing system build at the client site, interface specification documents and previous customer communications demonstrate that the customer implemented and accepted the picis edis in 2008. During this process, the picis edis system was configured to display all results sent from the customer's enterprise system rather than configuring the results display in 'overwrite' mode. Prior to acceptance, an investigation by picis and the client revealed that it was the sending system, sending multiple duplicate results messages [great quality - ed.] and a request was made by the customer of that enterprise vendor [I can only wonder who that was - ed.] to investigate. However, due to the enterprise system's protocol for 'add on' tests, it was not possible to utilize the 'overwrite' configuration due to the risk of filtering out unique results and subsequently not presenting the clinicians with important info. Therefore, the customer elected to have all results displayed.
A workaround that apparently, from the limited information provided, led to physician confusion..."the context of which the customer had", not very helpfully, "declined to clarify any further."
Hospitals also are required to have add'l safeguards in place for the handling of critical results including expedited reporting of critical results with a licensed responsible caregiver rather than relying solely on standard results reporting processes (joint commission national patient safety goal 02. 03. 01).
This is not a resounding statement of confidence in health IT...
The customer is currently working with a 3rd party integration consultant to improve the handling of results sent to picis' electronic health record application. We are providing support as it is requested. At this time, no corrective action is needed.
The "senior leadership" that withheld details was protecting what, exactly? Money and contracts, perhaps; conflicts of interest, possibly ... but not patients.
All I can say is:
Imagine if this was a report on a new drug suspected of harming people.
What in heaven's name was going on here?
As I've written many times, and as illustrated by this MAUDE report, the health IT industry must first be transformed into one of evidence-driven IT practices and transparency before anyone touting its products has any business even speaking about the technology "transforming medicine."
-- SS
