Diagnostic Harm: A Harm Unto Itself or One of Many?

Overview

In recent years Pascal Metrics has observed that many clinical leaders at leading hospitals and health systems are interested in finding and reducing diagnostic errors and, more broadly, diagnostic harm ^[1]Analogous to the distinction between medical “errors” and patient “harm” generally, diagnostic errors refers to those adverse events that occur when clinicians deviate from policies and … Continue reading The level of attention on diagnostic harm in peer-reviewed medical journals, regulatory agencies, and not-for-profit grant-making entities is striking. Since To Err Is Human was published in 1999, the patient safety field seems to have had its own version of hype cycles, which tend to consume disproportionate organizational energy and resources: team training; safety culture assessment; the Global Trigger Tool; CUSP (Comprehensive Unit Safety Program); high reliability; predictive analytics; diagnostic harm; and more.

More recently, the disproportionate focus on diagnostic harm recalls what Dr. Don Berwick once observed: “

“We’ve made progress since the To Err Is Human report…in particulars of care [harm]: fewer pressure ulcers; fewer central line infections; progress in medication reconciliation. But we’ve not made healthcare systematically. And we won’t, we can’t, until we take stock of the safety levels in an organization systemically and at a price we can afford.”

This is the central problem today with diagnostic harm initiatives: it’s important but not only are other frequent and severe harms worthy of attention and resources but, without doing that, this disproportionate focus results in yet another tactical unsustainable effort on only one part of a very big problem. The following questions are worthwhile to answer directly:

• Does diagnostic harm merit more attention than all causes of patient harm?
• Should diagnostic harm be identified using a different method than all-cause harm?
• Are current efforts as described and recommended operationalizable and sustainable?

The answer to all of those questions is “No”. While diagnostic harm is an important type of harm, it remains just that: it is a “particular” type of harm that should be addressed within an overall vision, strategy, and plan of identifying and reducing both global harm and specific harm. This blog explains why and how in further detail.

Cost Economics of Patient Safety

As a foundational matter in understanding how best to address diagnostic harm (or any type of harm), what must be understood first is a snapshot of the cost economics of patient safety. Key principles include:

• Every patient safety activity has a fixed cost and a variable cost
• Non-recurring patient safety activities generally each have a fixed cost and, due to often being manual, are high
• Most hospitals use multiple, disparate patient safety “tools”, workflows, data sets, and methods — a non-integrated cauldron of complexity, increasing all costs
• A platform and common workflow may have a higher fixed cost but offers lower costs of experimentation, adoption, and ongoing deployment
• Most hospitals and health systems do not have the capability of measuring and managing the costs above

Pascal will devote a future blog to unpacking these concepts.

The Relevance for Diagnostic Harm

Diagnostic harm identification efforts are characterized by cost attributes that make ongoing work unfeasible. Shortcomings of most diagnostic harm efforts include:

• One-time or irregular research projects
• Exclude non-diagnostic harm identification and reduction efforts
• Highly retrospective, e.g. latencies of weeks or months ^[2]Video retrieved at https://www.youtube.com/watch?v=qJQteWQedwo accompanying publication of Classen DC, Griffin FA, Berwick DM. “Measuring Patient Safety in Real Time: An Essential Method for … Continue reading
• Not generating outcomes data used daily in intervention and improvement as well as resulting derivative data
• High in fixed cost (e.g. chart review) and suffer from lack of benefit due to poor scalability, actionability, and sustainability

In summary, research-oriented diagnostic harm efforts generally have a high fixed cost, are not integrated into daily operations, and have little prospect of being scaled for actionability and measurable ROI.

Pascal VPS: Identifying & Reducing All-Cause Harm, which includes Diagnostic Harm

Contrariwise, hospitals and health systems should be deploying diagnostic harm initiatives that are:

1. Ongoing operationally integrated programs
2. Addressing all-cause harm, which would include harm as a result of incorrect or missed diagnosis
3. Concurrent with patient care, or even predictive using on the outcomes generated (optimal for training models)
4. Generating outcomes data used daily in intervention and improvement, along with derivative data (e.g. common causes & contributing factors)
5. Spreading fixed costs of harm monitoring, measurement, and management across all safety programs and actionable, enabling sufficient ROI

Pascal Virtual Patient Safety (VPS) delivers all of the above and more. In short, instead of just focusing on diagnostic harm, VPS enables health systems to identify and reduce all harm and related cost, which includes but is not limited to diagnostic harm.

Moreover, at a far lower incremental cost within a higher ROI program, VPS provides documentation of common causes and contributing factors not only for all harm but also for those harms that are the result of incorrect or missed diagnoses. Why identify common causes and contributing factors of just diagnostic harm when it can be done for all harm? Or just the 5% of harm found by voluntary reporting?

Economically, so many patient safety initiatives fail due to the lack of measurability and the fact that, when they are measured, the scope and impact is tactical, narrow, and modest — meaning “the juice is not worth the squeeze.”

Without a broad and deep application of all-cause harm monitoring, measurement, and management across all patient safety initiatives on a daily basis, an organization will not achieve the ROI to justify investment and, as a result, fail to achieve sustainability.

Understanding the Gaps between a Research Approach and Daily Operations

In order to understand how this broader evidence-based methodology applies to a research-based approach, it’s useful to consider what is recommended by AHRQ, the U.S. agency tasked with further patient safety and quality improvement. The table below lists strategies recommended by the AHRQ “Measure Dx” study and also includes how the Pascal VPS solution addresses the research study’s limitations ^[3]Andrea Bradford, Ph.D. and Hardeep Singh, M.D., M.P.H., Measure DX: A Resource to Identify, Analyze, and Learn From Diagnostic Safety Events, Agency for Healthcare Research and Quality, U.S. … Continue reading

Indeed, the last strategy referenced by the the AHRQ study is the most promising of the four to use as the primary strategy on which a organization can lean. It relies on the “gold standard” approach of chart review and uses clinical data. However, any ad hoc approach including with respect to this strategy – i.e. multi-disciplinary teams implementing the AHRQ guide outside of a regular daily operational process – are likely to remain research-oriented and one-time/sometime efforts which, based on Pascal’s and other organizations’ experience, are unlikely to be integrated into daily operations and scale across large health systems across all patients all the time.

Pascal VPS: Measuring & Reducing All Harm, including Diagnostic Harm

Operationalizing and maturing health systems far beyond the the fourth AHRQ-recommended strategy is what Pascal does. This methodologically foundational strategy allows health systems to monitor, measure, and manage all harm and associated causes and factors — including but not limited to diagnostic harm. Pascal’s team has the expertise identified in the AHRQ study as required and more. Pascal’s core VPS solution enables a health system to:

1. 1. Measure all harm all the time for all patients establishing a longitudinal baseline using AE Outcomes
      
   2. Conduct common cause / contributing factor (CC-CF) analyses daily across every AE Outcome, including those caused by improper or missed diagnoses

With respect specifically to diagnostic harm — or any type of harm — doing the above enables a unit, hospital, and/or health system to:

• Generate diagnostic harm-related outcomes as a subset of #1
  
• Generate diagnostic harm-related CC-CF analyses
• Do the above on a daily basis which enables concurrent intervention and high frequency cycles of improvement, targeting diagnostic harm specifically, if and as a priority
• Avoid the diagnostic harm even sooner: because VPS not only is identifying all harm in a fine-grained manner as well as the CC-CF for each event and retaining the association of all of those data with other clinical data in the EHR, VPS is well positioned – unlike research initiatives of the AHRQ-described approach – to trigger not only on any harm outcome (including those caused by diagnostic harm) but also on upstream events that we know to be associated with CC-CF events, and doing so on an ongoing operational basis.

The VPS solution supports health systems in heeding Dr. Don Berwick’s call to “take stock of the safety levels in an organization systemically” ^[4]Berwick DM. Constancy of Purpose for Improving Patient Safety – Missing in Action. N Engl J Med. 2023;388(2):181-182.. And if both all-cause harm and diagnostic harm can be addressed, this is far more economically efficient, consistent with Dr. Berwick’s call to do this work “at a price we can afford.”

Takeaways

In summary, VPS can take interested hospitals which have successfully implemented foundational VPS beyond diagnostic harm initiatives that are largely narrow research projects. In doing so, hospitals can not only identify and reduce diagnostic harm but do so with operational efficiency and clinical effectiveness that are clinically and financially sustainable.

1. Clinical Operations. Traditional patient safety initiatives that are one-time research projects generating lots of disparate data sets without daily operational integration will continue to be destined to fail to generate significant ongoing clinical operational improvement and performance.

2. Financial ROI. The diagnostic harm problem is not a diagnostic harm problem but an all-cause harm problem which, in order to be financially sustainable, must be addressed comprehensively, strategically, programmatically, and operationally. While the fixed cost is higher, casting a broader net enables outsized benefit measured in a >3x annual ROI.

3. Extended Value. This same logic applies not just to maximizing the value from broader harm reduction efforts but also other sources of value such as risk management, CDI, equity, and even appropriateness efforts and revenue optimization.