Diagnostic Error

By Michael Handler, MD, MMM, FAAPL
CPS Medical Director

As most of you know, the patient safety movement as we know it was started in 1999 with the report “To Err is Human” and was followed in 2001 by its second report, “Crossing the Quality Chasm.” The third report in that series was published in September, 2015 and that report, entitled “Improving Diagnosis in Health Care”, was another landmark report in patient safety and the culmination of many years of study of the important process of medical diagnosis.

Basically, this publication addresses in great detail the topic of diagnostic error. Diagnostic error is defined by the IOM as the failure to establish an accurate and timely explanation of the patient’s health problem(s) OR the failure to communicate that explanation to the patient. Although the definition is somewhat controversial in the scholarly circles, the implication of some type of discrepancy in diagnosis is the common denominator and can include over-diagnosis, under-diagnosis or misdiagnosis. And the prevalence is quite staggering. Errors of this type are estimated to be responsible for 40,000 to 80,000 deaths/year in this country. Seventeen percent of adverse events are related to diagnosis and 20% of readmissions are related to the wrong diagnosis. Five percent of primary care visits involve a preventable diagnostic error and ten patients are harmed every day in clinics or emergency departments. It is likely that most of us will experience at least one diagnostic error in our lifetime, sometimes with devastating consequences.

So, I know what you are thinking. It is always the other clinician—not me—who makes errors in diagnosis. In fact, fewer than 10% of physicians admit to one diagnostic error per year and some physicians deny ever making an error. So, what are some of the more common missed diagnoses? Well, missed CVA, epidural abscess, meningitis, sepsis, acute coronary syndrome, abdominal pain and failure to diagnose a cancer, to name a few. Professional liability carriers state that diagnostic errors are second in the number of closed claims and the highest category of average indemnity payment.

When you look at why diagnostic errors occur, you must look at patient variables, system variables and practitioner variables. Patient variables include the stage of disease, how it manifests, how it is described and when help is sought. System complexity includes discounted care, communication barriers, production pressure and difficult access to care and expertise. Finally, practitioner variables include knowledge and experience, access to patient data, tests, consults, skill in clinical reasoning and stress, distractions, mood and time to think. We must also understand the concepts of cognitive biases of providers which lead to error. These biases include such things as anchoring bias which means relying on your initial diagnostic impressions, despite subsequent information to the contrary. These types of biases can lead to errors which perpetuate themselves.

How can we reduce errors? There is not one clear answer, but we can implement processes such as double checks and checklists to reduce reliance on memory and accept feedback from other clinicians whether from physicians, nurses or other professionals. We must also remember to work on improving teamwork, communications and handoffs.

The IOM report concluded with several goals to improve diagnosis and reduce diagnostic error, and these span the entire health care spectrum:

  1. Facilitate more effective teamwork in the diagnostic process among professionals, patients and their families.
  2. Enhance health care professional education and training in the diagnostic process. Educators are being asked to be sure their curricula include skills in clinical reasoning, teamwork and communication.
  3. Ensure health information systems support patients and health care professionals in the diagnostic process. Special reference was made to the elimination of such things as copy and paste, meaningless alerts and templates from the record. Instead, health IT vendors should be encouraged to work together with users to ensure that health IT demonstrates usability, incorporates human factors knowledge and fits well with clinical workflow.
  4. Develop and deploy approaches to identify, learn from and reduce diagnostic errors and near misses and establish ways to provide systematic feedback to physicians and other providers in the system. The goal is to find specific actionable items in a root cause analysis and actually fix them.
  5. Establish a strong culture of safety that supports the diagnostic process and improvements in diagnostic performance.
  6. Develop a reporting environment and medical liability system that facilitates improved diagnosis through learning from errors and near misses.
  7. Develop a payment and health care delivery system that supports the diagnostic process and the final goal is to provide dedicated funding for research on the diagnostic process and errors.

So, what are some things that you can do to reduce the incidence of diagnostic errors?

  • Work together with all members of the healthcare team to identify, learn from and reduce diagnostic errors. This includes collaboration with all members of the team including physicians, nursing, pharmacy and all other possible sources of information to help with the right diagnosis.
  • Sharpen communication skills and improve handoff communication so that nothing is missed which may lead to the right answer.
  • Use the electronic health record as a communication tool and not copy and paste just to get the documentation done — make sure it is correct and true.
  • Be willing to accept suggestions and feedback from others, always keeping the best care of our patient top of mind.

The area of diagnostic error continues to be a very dynamic area in patient safety and many unanswered questions remain. We must continue to look for opportunities to help minimize these errors to help to keep all our patients safe.

MICHAEL HANDLER, MD, MMM, FAAPL, is the Medical Director for the Center for Patient Safety. He has been an OB/Gyn physician since 1985, operating private practices in Missouri through 2007. The last ten years Dr. Handler has served as house obstetric physician, medical director for quality improvement, and chief medical officer for several SSM Health hospitals in the St. Louis area. In early 2017 he accepted the position of chief medical officer for Amita Health Alexian Brothers Medical Center and Amita Health St. Alexius Medical Center in suburban Chicago. Dr. Handler earned his medical degree at University of Missouri-Kansas City School of Medicine. He completed his internship and residency in Obstetrics and Gynecology at St. Louis University Hospitals. He has a Master of Medical Management degree from Tulane University and is a fellow of the American College of Physician Executives.

Do you have an EMS Patient Safety Plan?

While we have all heard the old saying, “do you plan to fail or fail to plan,” this short statement has likely influenced many people to re-evaluate a current process or situation in their life.  The specialty area of preventable harm or patient safety is gaining strong momentum in Emergency Medical Services, which has relied on another common old saying “do no harm”.   While the desire to do no harm has always been present in EMS, it isn’t until recently that coordinated efforts have come forward to inform, organize and delineate actionable plans and steps to reduce preventable harm at the organizational level.

The EMS Patient Safety Boot Camp is a great way to get started, or to improve your current patient safety journey.  An opportunity in beautiful, cool Denver is waiting for you!


Patient Safety Resources

Are you frustrated because others in your organization don’t seem to have the same passion or urgency to improve patient safety?  Limited resources and increasing financial pressures are driving the focus on patient safety down on the list of priorities.  It’s difficult to build a business case to support the importance of constantly improving patient safety.  Now there’s help!  The Institute for Healthcare Improvement and National Patient Safety Foundation recently published a resource to assist you – and it’s free!  Remember that improving patient safety is a journey, not an initiative.  Never give up!

CPS Safety Culture Assessment

“I am very impressed with the reports. I know my leadership team will be thrilled to have the individual reports by their division. This
has been a very positive experience for me.”

“We love the Center’s patient safety culture survey feedback reports. The department level reports give a level of granularity we
were lacking with previous surveys.”

The Center focuses heavily on culture to support patient safety improvement. A punitive environment discourages open communication of events and near misses, creating a barrier to learning about the mistakes that are occurring.

The Center has been administering the AHRQ Surveys on Patient Safety (SOPS) since 2011. Since then, we have administered hundreds of thousands of surveys and provided survey support, feedback reports, and consultation to hundreds of organizations.

A select group of 42 hospitals were selected from the 2016 database. These organizations were selected based on their activity level and extended use of the Center’s resources and services for PSO participation, webinar attendance, resource usage, and consulting. An analysis of their patient safety culture scores are compared to the national compare database from AHRQ. More than 14,000 surveys were analyzed.

  • 7 dimensions were equal to or higher than the 50th AHRQ Percentile
  • “Nonpunitive Response to Error” ranked in the 75th AHRQ Percentile
  • 23 questions were equal to or higher than the 50th AHRQ Percentile
  • “We are actively doing things to improve patient safety” ranked in the 90th AHRQ Percentile

The top strengths for these organizations align with the top strengths from the 2016 AHRQ Hospital Compare Database:

However, the areas with potential for improvement, or the lowest scoring dimensions, indicate variation in two of the composite scores:

The Center has had a long history with a focus on creating a nonpunitive environment. The dimension includes the question “Staff worry that mistakes they make are kept in their personnel file.” The higher score for the composite “Nonpunitive Response to Error” is statistically significant (>5%). Compared to the national average, the organizations in our select group are in the 75th percentile nationally.  While most of the respondent emographics for the hospitals included in the Center’s summary align with the AHRQ Compare Database, it is worth noting:

  • 15% of staff indicated they report 11-20 event reports per year; 29% indicated they report 3-5 events per year (statistically significant variation from AHRQ National Compare Database)
  • Higher numbers of reports suggest an environment that supports open communication without a fear of retribution or punishment.

Additional notes:

  • 85% of respondents had direct patient care
  • 41% of staff worked 1-5 years in the current work area
  • 36% of staff worked 1-5 years in the current hospital; 13% worked 21 years or more in the current hospital
  • 44% of staff indicated they were a Registered Nurse

Click here to download the full data report.

Interested in receiving reports like this for your organization’s departments or locations? Request a no obligation price estimate with a summary of the Center’s survey administration services.

PSO Legal Update: A new focus on reporting

The Center for Patient Safety’s staff has been fielding a lot of questions about what information can be protected under the Patient Safety and Quality Improvement Act and how that relates to reporting to the PSO.  The basic rules have not changed, but there is some new focus on reporting, which is the touchstone for all the definitions in the Act and the Final Rule.  So, this explanation will start at the beginning.  

The Act defines Patient Safety Evaluation System (PSES) as “the collection, management, or analysis of information for reporting to… a patient safety organization.”  The PSES can collect, manage and analyze; it need not just gather information and report it in its “virgin” form.  Inside the PSES, information can be aggregated, sorted, evaluated or otherwise processed as part of the organization’s patient safety activities.  

The Act has a two-prong definition of Patient Safety Work Product (PSWP).  The first prong is information “assembled or developed by a provider for reporting to a patient safety organization and… reported to a patient safety organization.  AHRQ refers to this as the “reporting pathway.”  That information needs to be gathered for purposes of reporting and actually reported.  The language itself does not address non-reported material.

The second prong of the PSWP definition, though, is the source of much value for PSO participants, as it is what protects the actual work within their PSES.  The Act also defines as PSES items “which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.”  To meet this definition, the PSES must conduct some deliberation and analysis of information that it has acquired.  And since the purpose of the PSES is to develop reportable information, the deliberations and analysis must take place in the course of (and generate material related to) synthesizing reported material.

CPS does not believe this means that ONLY information reported to the PSO can be protected.  We do, however, recommend that our participants only try to protect information that comes into the PSES or is developed within the PSES as part of a process that leads to reports to the PSO.  Those reports can be in the form of Common Data Format reports, root cause analysis that you send to a PSO or information that is functionally reported in connection with some actual reporting.  (If you have questions about functional reporting, you should contact CPS.)  And remember, you can meet the reporting requirement by sending your PSO PSWP or non-PSWP.  So, if you need to share a part of your RCA with a regulator, you can still report it and protect the process that developed it.  The point of reporting is to share your learning with others.

CPS staff will continue to remind our participants of the importance of reporting.  We don’t know how much is enough, but we know that an absence of reporting will lead to an absence of protection.

CPS Releases PSO Report: #CultureForward

The Center for Patient Safety, a Patient Safety Organization (CPS PSO), is pleased to present this report summarizing some of the information we are learning from the collaborative participation of healthcare providers across the country.

Please note throughout this report, each contracted provider with the CPS PSO participates voluntarily. Each participating organization may elect to report different types of patient safety events, or they may elect to only submit information about the least or most severe cases, therefore, analysis of PSO data is always conducted with this understanding. Benchmarks and rates are unattainable without having a complete data set, so the information in this report is intended to offer a snapshot of the trends and findings from the thousands of events we have collected from hospitals, long-term care organizations, health systems, home health, emergency medical services, and medical offices.

We hope you find value in the information we have provided in this report. If you are not yet participating with a PSO, please contact CPS and we would be happy to help you with your selection process. All PSOs are different and it is important that you find the one that best meets your needs. As a reminder, organizations can participate with more than one PSO. We would encourage you to do so if there are beneficial offerings to your organization. Some PSOs are specific to, for example, children’s hospitals, while others may be specific to Pharmacies. CPS works across the continuum of care and is positioned to help you achieve your greatness.

I encourage you to review this report and compare the findings to patient safety concerns at your own organization. Contact me or any member of the team for information about how we can support your organization as an extension of your quality or safety department. We want you to be successful!

Download the Report

Patient Safety Boot Camp Now Available for EMS

Patient Safety Boot Camp Now Available for EMS

There’s lots of talk in the EMS world about patient safety and patient culture, but few resources to assist agencies in improving their culture and moving forward.

The Center for Patient Safety (CPS) has taken action. Based on similar work done in the acute setting several years ago, we have developed a day-long Patient Safety Bootcamp for EMS professionals.

Attendees will learn the basics of the science of patient safety, human factors, error reduction, process improvement and measurement. Presentations are in TED talk style, with “work-out” discussion sessions after each topic for attendees to analyze how their agency is fairing relative to the presented topic. Tools such as fishbone, root cause analysis, prioritization matrices and action plans are used throughout the day.

The goal is for each participant to leave the boot camp with either the start or refinement of a patient safety plan. Presenters are safety specialists with many years of experience in patient safety and quality improvement.

I encourage EMS personnel to consider this unique opportunity to dive in to patient safety!


JULY 25:  , BRANSON, MO Preconference workshop- MISSOURI EMS EXPO

  • Special guest speaker: TBA

AUGUST 2: Tomball, TX –Greater Houston area

  • Hosted by- Northwest Community Health
  • Special guest speaker: TBA

AUGUST 23-24: DENVER, CO as part of the National EMS Safety Summit


  • Special guest speaker: TBA

Zero Harm

Zero Harm – that’s the goal for every health care provider!  The only way to achieve this is for patient safety to be embedded into your culture.  That means  organizational leaders make it a priority by “walking the walk and talking the talk”. The culture must change the providers’ thinking from “it’s a known complication” or “it sometimes happens” to “not on my shift!”  Recently the American College of Healthcare Executive and the National Patient Safety Foundation released a whitepaper which provides guidance and tools to advance your organization’s culture of safety.   Whether you are just beginning your journey or are attempting to sustain levels of improvement, click here to downlad the guide which will be useful in directing your efforts and evaluating your success along your journey to zero harm. 


A Need for Speed

By: Lynnette Torres, Quality Improvement Manager for Memorial Hospital of Carbondale

Sepsis – a dreaded word for patients, families and health care providers alike. Sepsis is an infection caused by microorganisms or germs (usually bacteria) invading the body. It can be limited to a particular body region or be widespread in the bloodstream.

Addressing the Challenge
In addition to outcomes, the Agency for Healthcare Research and Quality lists sepsis as the most expensive condition treated in U.S. hospitals, costing more than $24 billion in 2013 increasing on average annually by 11.9%. It has been estimated that if the U.S. as a whole achieved earlier sepsis identification and evidenced based treatment, there would be 92,000 fewer deaths annually, 1.25 million fewer hospital days annually, and reductions in hospital expenditures of over $1.5 billion.2 Research has shown that mortality from sepsis increases 7% every hour that treatment is delayed. As many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment.3 Understanding this severity, Memorial Hospital of Carbondale, Illinois, began addressing the sepsis
challenge several years before it became a focus for the Centers for Medicare Services (CMS). A multi-disciplinary improvement team began studying sepsis, and realized how much more difficult and unique it is to meet all the requirements than the previously required core measures from CMS.

Making it Easier
The team began working on revising all order sets that are used for patients who may be septic, including the required measures of the Sepsis Bundle: blood cultures, lactic acid, antibiotics, fluid resuscitation, and vasopressors. A Kaizen project focused on the work flow for septic patients as well as components of the evidenced-based sepsis care bundle. Revised sepsis order sets for patients in triage, the ED and inpatient nursing units now include the required measures. These changes make it easier to ensure the proper care is provided in a timely manner. All nursing staff, hospitalists and ED physicians were educated on the sepsis requirements and new order sets. One-on-one education was provided when necessary. “Cheat sheets” and guides for sepsis care were created for physicians and nursing staff. The sepsis care path was laminated and placed on computers as a visual reminder. A checklist was created for nurses and physicians in the ED; these checklists double as a hand-off tool to communicate the continuum of care between providers.

Memorial has concurrent and retrospective nurse abstractors in the Quality Department. The concurrent abstractor reviews the patients who meet sepsis criteria daily, along with tracking use of the sepsis order sets.  Order set compliance data is shared with the providers.

“There are approximately 750,000 new sepsis cases each year in the US, with at least 210,000 fatalities. As medicine becomes more aggressive, with invasive procedures and immunosuppression, the incidence of sepsis is likely to increase even more. Reducing mortality due to severe sepsis requires an organized process that guarantees the early recognition of sepsis along with the uniform and consistent application of evidence-based practices.”

Moving Forward
The team continues to meet and seek ways to simplify the order sets to increase compliance. One of the challenges is missing the required lactic acid timeframe for admitted patients who have the first blood drawn in the ED but are not in their inpatient room when the Lab phlebotomists go to draw for the second order. The phlebotomists now place a sign above the bed indicating that they have been there, asking nurses to please contact the Lab so the second draw may be done in a timely manner.

The Results
Since the sepsis core measure is “all or nothing” for compliance, it is a challenge. However, the results at Memorial Hospital are consistently improving. Use of the revised sepsis order sets started in the low teens and has increased to about 65%. Total compliance with the Sepsis Bundle has increased to the mid-50’s. The team continues to meet every other week and gather input from the ED physicians and hospitalists to address the challenges, one of which is early recognition of sepsis so the timeframes can be met.

For More Information
Lynnette Torres is the Quality Improvement Manager for Memorial Hospital of Carbondale. For more information, including the tools used by Memorial Hospital of Carbondale, contact Lynette at 618-549-0721 Ext. 65472 or 618-684-3156 Ext. 55610. Memorial Hospital of Carbondale is a 140-bed tertiary care hospital, serving as the flagship hospital for Southern Illinois Healthcare and regional center for the 16-county southern Illinois region.

QAPI: 10 Steps to Improvement

Long-term care providers face new expectations for their safety and  quality work in the form of CMS’ QAPI standards. Yet a simple and methodical approach can help LTC providers create a program that meets CMS’ expectations and improves care for residents. Primaris has published a great list of suggestions (“10 Simple and Effective QAPI Planning Tips”) for those who want to strengthen their program; it is available here.

And remember:  CPS has tools and programs that can be integrated into this planning for an even stronger program. The AHRQ Survey of Safety Culture helps LTC organizations identify areas ripe for QAPI improvement and helps measure baseline and post-intervention safety culture to demonstrate improvement.  CPS also offers programs to help with the improvements that might grow out of the survey.  And organizations that participate with CPS’ Patient Safety Organization (PSO) can share their learning and protect it from discovery at the same time.

For  information about the AHRQ Safety Culture Survey, contact Alex Christgen ([email protected]).

For  information about  the Center for Patient Safety PSO, contact KathyWire ([email protected]).


PSO Case Law: Ungurian v. Beyzman, et al., 2020 PA Super 105:

A recent Pennsylvania case shows how courts narrowly interpret the PSQIA, ignoring the D & A pathway and the clear language of the Final Rule. (Ungurian v. Beyzman, et al., 2020 PA Super 105). The cour

Joint Commission New Sentinel Event Alert 61: Managing the Risks of Direct Oral Anticoagulants:

The Center for Patient Safety wants to share this important harm-prevention advice from The Joint Commission and its Sentinel Event Alert: Managing the Risks of Direct Oral Anticoagulants. The Joint Commis

CPS Safety Watch/Alert – Culture Can Improve the Control of Multi-Drug Resistant Organisms:

Issue: A number of events reported co CPS’ Patient Safety Organization (PSO) demonstrate poor handoff communication about the patients’ infectious disease status Examples include: Patient with

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The Center for Patient Safety believes that collaboration and sharing are the best ways to drive improvement. We strive to provide the right solutions and resources to improve healthcare safety and quality.