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

USA Today: Medicare Inspector General - "More tracking of serious errors needed"

Have to applaud this report since reporting and tracking are often the first steps towards improvement:

In an excerpt from the article - "That means that those hospitals ... don't learn from their mistakes, Inspector General Daniel Levinson writes .. No one tracks the effectiveness of policy changes or how the hospitals actually correct mistakes." 

These statements get at the real crux of the matter - serious adverse events are happening everyday throughout the nation's hospitals. However, are we learning and responding appropriately to the same in order to reduce the risk of injury for subsequent patients? 

In addition to reporting and tracking of the errors, we need robust risk mitigation and performance improvement systems to ensure that patient safety is being improved:

• Root cause analysis of these events to get to the incipient causes of the errors.
• Corrective action plans that hospitals are held accountable to in order to ensure that the root causes are mitigated.
• Failure modes and effects analyses (FMEAs) to ensure that we understand all the myriad ways systems can fail.
• Systems redesign to ensure that the culture, workflow, clinical actions, and behavior that led to the error are truly modified.
• Auditing and Monitoring of systems and outcomes to ensure that the intended changes have gone into effect.
• Real-time assessments of adverse events in order to mitigate immediate risk to the patient in front of us - in addition to retrospective analyses or prospective improvements.

As outlined above, many actions can be taken to improve patient safety. Unfortunately, as hospitals continue to be impacted by the recession - reductions in volumes, cut-backs in budgets, and cuts in reimbursement, patient safety staffing and patient safety systems are not as robust as they need to be.  We can mandate more monitoring, reporting, and tracking of errors, but unless we work with hospitals to develop the infrastructure required to build patient safety systems, patients will continue to be harmed by the very systems intended to help them.

Transparency, Disclosures, and YouTube

does anyone else out there get a feeling that the pendulum on public disclosure and transparency is about to swing too far in the other direction .. is this really about doing the right thing for the patient? or is it merely capitalizing on a market trend towards consumerism and transparency?

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By Laura Landro

Pitching Patient Safety and Hospital Transparency on YouTube

After a medical error, hospitals’ traditional approach has been to retreat behind a wall of silence, on the advice of risk managers and attorneys. But some hospitals are taking a different approach, fully disclosing medical errors, apologizing and offering financial compensation up front – and inviting patients and families to participate in patient safety improvement efforts. For a look at how one hospital is working with the family of a child harmed by a medical error to improve safety, see my latest WSJ column.

While some experts have warned that the full disclosure approach could lead to more lawsuits and higher payouts the experience of the University of Illinois Medical Center at Chicago suggests otherwise. In 2004, the hospital created a consultation service to help staffers communicate quickly with patients and families about safety incidents; in 2006 that evolved into a policy of full disclosure, apology and a swift offer of financial compensation. Over the four-year period, the number of lawsuits dropped 40% from the prior five years, and there has been no increase in financial payouts, according to chief safety officer Timothy McDonald.

“How we respond to these events defines who we are as individuals, organizations and our professions as a whole,” says McDonald, who is both a pediatric anesthesiologist and a lawyer by training. “Open and honest communication between caregivers and their patients and families starts the process of healing and closure – for both the patient and the caregiver.”

The first step is creating a culture that punishes those who recklessly endanger patients but holds blameless those who are involved in errors linked to flawed systems or products. The 450-bed academic medical center uses a carrot and stick approach, praising staffers who promptly report incidents and penalizing those who fail to do so. Departments that fail to promptly report incidents see a larger share of malpractice premiums assigned to their department budget.

Those changes have led to a doubling of the number of patient safety incident reports to about 2,000 in each of the last two years; about 10% of the incidents caused serious patient harm, leading to 20 full disclosures to patients and families of inappropriate or unreasonable care. Equally important, the program has identified safety gaps that have led to nearly 200 improvements in hospital procedures, according to McDonald, who will report on the program’s findings in an upcoming edition of a patient safety journal.

McDonald and a colleague, cardiac anesthesiologist Dave Mayer, are producing a series of patient safety videos to highlight process improvements following harmful patient events and disclosure. The videos, which will be sold to hospitals for use in patient safety education programs for staffers, also aim to teach patients how they can take a more active role in their care and provide critical input caregivers may miss. The YouTube video embedded in this blog post is trailer for the first video, “The Faces of Medical Error: From Tears to Transparency,” which will debut September 24th at the University of Illinois.

TransparentHealth, that brand name you see in the video, is a for-profit patient safety education company founded by McDonald and Mayer. They say any profits will go to the foundations of the families whose stories will be told in the videos, and to fund the making of the subsequent films. They chose to go for-profit because they were unable to secure funding and saw the need for the videos.