Should Patients Get Direct Access to Their Laboratory Test Results?

I blogged recently about "breakdown in communication of test results" and subsequently saw this piece in JAMA referencing some of the same issues and discussing whether "patients should get direct access to their laboratory test results".

The authors do a great job discussing the pros and cons of this potential solution to "communication breakdown" from both patient and physician point-of-view. In the context of performance improvement, patient direct access could certainly help to reduce some communication issues. However, it may not improve outcomes if patients are not clear about how to interpret the results. It could set up a further discontinuity within the system if there is confusion about "who is responsible for following up on the results?"

If part of a well-designed system, this initiative could help simplify the process by reducing steps in the communication chain and provide redundancy to reinforce patient safety. However, if implemented without careful thought to many of the questions posed by the authors, it could increase the complexity of the communication dynamic and lead to breakdowns of a different sort. 

Dangerous Assumptions & Lack of Systems: Breakdown in Communication of Test Results

This article in the Washington Post points out a disturbing, yet unfortunately widespread, cause of medical errors: breakdown in communication of test results.

The Joint Commission addresses the issue as one of its National Patient Safety Goals for hospitals. However, systems at many hospitals and physician offices are not "airtight" enough to assure the reliable transmission of information and the delivery of safe care.

The "root cause" for this error generally comes down to one of a few common factors:

• Staff too busy with their "day-to-day" routine. 
• If the result reporting process is not well-integrated into their clinical workflow, there is a high likelihood of system failure.
• No clear process identified for handling of critical lab results.
• This is probably the "over-arching" root cause for the issue at hand. If the process for communication is not robust, not well disseminated, and not monitored, it will inevitably lead to errors. 
• Miscommunication about who in the hospital/ office is handling the communication.
• Results may get reported to a non-clinical staff member (such as a Unit Clerk or Office Manager) who is not the right individual to interpret the significance of the findings.
• Physician was not reachable despite numerous attempts.
• Sorry to say that this is probably one of the most common reasons for failure to relay critical test information, particularly in a busy hospital setting. 
• Lab techs, nurses, and other staff try to follow an "established process", but the process is doomed to repetitive failure because one of the key steps is not reliable.
• Results get communicated, but subsequent "changes to reports" are lost. 
• Unfortunately, this happens often for tests that have to be "incubated" (such as microbiology reports) or "reviewed" (such as radiology reports).
• Test results that cross clinical settings (such as hospital to provider office) are prone to getting lost. 
• Every provider and every hospital may have a different mechanism and process for communicating critical test results. This increases the complexity of the process exponentially, and makes it more prone to break down.
• When there is not "one standardized process for communication" across the local healthcare system, how do we expect individual physicians, staff, and even organizations to ensure reliability?

The system described by Dr. Eric Poon at Brigham and Womens Hospital is a constructive approach to this problem:

However, this system is mostly reliant on an electronic interface, which may not be applicable to all providers in a diversity of clinical settings. In addition to using electronic systems wisely, healthcare providers should remember the key principles of performance improvement for systematically reducing the likelihood of error in this vital clinical process:

• Undertake a root cause analysis for any specific errors at the respective institution
• Undertake a FMEA (failure modes effect analysis) to formally assess the likelihood of systems breakdown for key processes
• Ensure that a specific process is laid out and communicated widely to all staff and physicians
• Build in redundancies to ensure that an "adequate safety net" is in place to catch errors before they affect a patient
• Monitor data both on outcomes (errors reaching the patient) as well as critical steps in the process (such as success in test result handoffs)
• Report data widely to staff, physicians, leadership
• Provide feedback to staff and physicians on individual errors
• Incorporate education about process into staff orientation and ongoing training forums

Could Performance Improvement Systems Reduce Communication Errors, Malpractice Payments?

From this recent article in FierceHealthcare, failures to communicate have resulted in 40% increases in malpractice premiums from 1996 to 2003.

Some of the common reasons cited for communication breakdown: "Physicians and patients might not receive results, report findings may be delayed, and there may by lengthy turnaround time. Together, these three communication failures across all specialties totaled $91 million in payouts in 2010, compared to $21.7 million in 1991."

Automation is touted as one of the potential solutions to this issue, which it certainly is. Automation can take out the human element from the workflow equation, which generally improves the reliability of a process (as long as the workflow is otherwise designed properly). However, automation has its limitations as well:

• The wrong fax numbers may be entered in the system, thereby sending documents either to wrong parties, or to a document neverland. This can create more quality and risk issues.
• Changes to the system can lead to breakdowns in other parts of the system, requiring constant vigilance.
• Not all parties use the same technologies thereby making the connectivity more problematic.
• Automation can convey the false-sense of reliable transmission, but it is generally unidirectional, and as such, may not be able to ensure that the recipient has actually received the document (no matter if the fax machine confirms that it was sent) nor that the matter is handled with the same urgency as the sender intended. 
• In the "clinical emergency arena", nothing beats the direct phone call, provider to provider, to ensure that the communication and intended actions do not fall through the cracks.

Beyond issues with automation, however, the biggest opportunities to improve communication lie in developing and implementing reliable systems for communication:

• Are there clear protocols for which tests and what test results are considered critical, thus, requiring "critical communication"?
• Is this list as appropriately narrow as it can be, and are the cutoffs for the test results truly clinically meaningful? 
• Having a comprehensive list can dramatically increase the number of times "critical communication" is expected to take place, and increases the likelihood of "communication fatigue" or "overload".
• Is there a clear process for "critical communication"?
• Is there a reliable system for training and re-training all staff in the "critical communication" process?
• Is the process for "critical communication" as streamlined as it should be?
• Are there staff involved in the process that don't need to be?
• Are the key steps in the critical communication process being monitored and measured?
• How often do the steps breakdown in the critical communication process, and when they do, what action is taken to address the systems or staff issues related to the breakdown?

Unless an organization develops a performance improvement framework for critical communication - implementing systems, defining protocols, redesigning processes and workflow, and monitoring data - it is unlikely that any technology or automation will resolve the communication breakdown.