Though data on delays in treatment due to misdiagnosis have been collected by TJC since 2015, misdiagnosis is not listed among the reported top 10 sentinel events
Accurate diagnosis could be the most critical aspect of all
healthcare. Without accurate diagnoses, doctors may be delayed in starting
treatment for their patients. In other cases, ordering inappropriate clinical
laboratory tests might contribute to a misdiagnosis.
SIDM’s analysis revealed that “one in three malpractice cases involving serious patient harm is due to misdiagnosis.” And that, “Cancer, vascular events, and infection account for three-fourths of high-harm, diagnosis-related claims.”
Therefore, it seems odd that misdiagnosis would not be front and center on the latest list of Sentinel Events from The Joint Commission (TJC), the non-profit organization that accredits more than 21,000 healthcare organizations on behalf of the federal Centers for Medicare and Medicaid Services (CMS). Was it omitted? Perhaps not.
What Is a Sentinel Event?
The Joint Commission adopted its formal Sentinel Event
Policy in 1996 as a way to help healthcare organizations improve safety and
mitigate future patient risk. TJC defines a sentinel event as a “patient safety
event that reaches a patient and results in any of the following:
“death,
“permanent harm,
“severe temporary harm, and
“intervention required to sustain life.”
TJC determines healthcare events to be “sentinel” when they
“signal the need for immediate investigation and response.”
Misdiagnosis leading to preventable medical errors would
seem to be a sentinel event, but it is missing from TJC’s list for the past two
years. It’s not, however, missing from an earlier TJC list of preventable
diagnostic errors.
Delay in Treatment Due to Misdiagnosis
A 2015 TJC advisory report on safety and quality issues in healthcare, titled “Preventing Delays in Treatment,” lists misdiagnosis among several reported events that led to delays in diagnosis that then led to patient harm or death.
In that report, TJC defines “delay in diagnosis” as “a
non-optimal interval of time between onset of symptoms, identification, and
initiation of treatment. A delayed diagnosis occurs when the correct diagnosis
is delayed due to failure in or untimely ordering of tests (e.g., [clinical
laboratory] work, colonoscopies, or breast imaging studies). Whether due to
delay in diagnosis, misunderstanding of the disease, misdiagnosis, or failure
to treat, delay in treatment can reduce the number of treatment options a
patient can pursue.”
So, misdiagnosis was, at that time, an event the TJC
collected data on and included in its advisor statements. But since then, it
has been omitted from the list. What changed?
Recent Sentinel Events
Turns out, nothing really. Though misdiagnosis is not listed on TJC’s lists for 2018 and 2019, it is part of a more comprehensive list published by TJC in February titled, “Most Commonly Reviewed Sentinel Event Types.” That report offers more details on the listed sentinel events, and also includes a section drawn from TJC’s 2015 report on delays in treatment, which covers results due to misdiagnosis.
Unanticipated events such as asphyxiation,
burns, choking, drowning or being found unresponsive
Suicide
Delay in treatment
Product or device event
Criminal event
Medication error
Then, in August, TJC release a new report based on the 436 reports of sentinel events TJC received in the first six months of 2019. They include:
Anesthesia-related events
Care management events
Criminal events
Environmental events
Product or device events
Protection events
Suicide—emergency department
Suicide—inpatient
Suicide—offsite within 72 hours (these are
defined in the Sentinel Event Policy)
Surgical or invasive procedure events
Following the release of its March sentinel events list, TJC noted that the components were typical when compared to previous years.
“The trend for the most frequently reported sentinel events remains generally unchanged,” stated Gerard Castro, PhD, MPH (above), Project Director, Patient Safety Initiatives at The Joint Commission, in a PSQH analysis of the Joint Commission’s 2018 list of sentinel events. “Organizations should continue their work toward minimizing risks associated with these types of events, but also strengthen systems and processes that keep patients safe, such as reporting and learning from close calls, teamwork, and improving safety culture.” (Photo copyright: The Joint Commission.)
TJC’s website notes, however, that “fewer than 2% of all sentinel events are reported to The Joint Commission. Of these, 58.4% (8,714 of 14,925 events) have been self-reported since 2005. Therefore, these data are not an epidemiologic data set, and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
Might that be because the healthcare organizations in the US
accredited by the Joint Commission are “encouraged” to report sentinel events
and not “required” to do so? This also allows accredited healthcare
organizations to pick and choose which events to report to TJC.
If there is one easy conclusion to draw from all the information presented above, it is that the true rate of misdiagnoses—as well as other types of sentinel events—remains unknown. But what is equally true is that, step by step, the adoption and use of electronic health systems (EHRs), along with other digital tracking modalities, will make it easier for providers and healthcare policymakers to more accurately identify and classify instances of misdiagnoses.
When that happens and better data on misdiagnoses is
available, it will be possible for medical laboratory professionals to use the
methods of Lean
and quality management to collaborate with physicians and other providers. The
first step will be to identify the sources of misdiagnoses. The second step
will be to use these quality improvement techniques to support providers in
ways that allow them to reduce or eliminate the causes of diagnostic errors and
misdiagnoses.
Especially for busy hospital emergency departments, avoiding blood culture contamination is a constant challenge for those tasked with collecting blood culture specimens
Better, faster diagnosis and treatment of sepsis continues to be a major
goal at hospitals, health networks, and other medical facilities throughout the
United States. Yet microbiologists
and clinical
laboratory managers continue to be frustrated with how frequently
contaminated blood culture specimens show up in the laboratory.
A recent poll of more than 200 healthcare professionals who
attended a
sponsored webinar hosted by Dark Daily, showed that nearly 10% of
those who responded reported an overall blood culture contamination rate in
their hospitals at above 4%.
However, the arrival of new technology may provide hospital
staff with a way to reduce contamination rates in blood culture specimens, in
ways that improve patient outcomes.
The effectiveness of a new tool, the Steripath Initial Specimen Diversion
Device (ISDD), is being demonstrated in a growing number of prominent
hospitals in different regions of the United States. What will be particularly
intriguing to clinical laboratory professionals is that the ISDD is capable of
collecting blood while minimizing the problems caused by human factors, micro-organisms,
and skin plugs or fragments. This device was developed by Magnolia Medical Technologies
of Seattle, Wash.
The ISDD isolates the initial 1.5
to 2.0 mL aliquot of the blood culture sample, which is most likely to be
contaminated with microscopic skin fragments colonized with bacteria. The device diverts this initial aliquot into a sequestration
chamber, mechanically isolating it from the rest of the sample, and then
automatically opens an independent sterile pathway into blood culture collection
bottles.
Such technology may be welcomed by medical laboratory
professionals based in hospitals and other healthcare facilities. That’s
because it is the lab staff that typically identifies a contaminated blood
culture specimen and must go back to the nurses, staffers, and physicians on
the wards to have them redraw an acceptable specimen that will produce an
accurate, reliable result. Patients under these circumstances generally
continue on unnecessary broad-spectrum antibiotics, and their length of stays
have been reported to increase by two days on average.
Problem of Decentralized Phlebotomy
One problem contributing to high blood culture rates is
that, in many hospitals and health networks, phlebotomy has been decentralized
and is no longer managed by the clinical laboratory.
“I’ve seen the havoc decentralized phlebotomy wreaks on contamination rates of blood culture rates,” stated Dennis Ernst, Director of the Center for Phlebotomy Education based in Mio, Mich. “That staffing model, which swept through the hospital industry in the late 1990s, may have looked good on paper, but I can count the number of facilities that have successfully decentralized on the fingers of one hand. And I don’t know of any decentralized setting that has an acceptable blood culture contamination rate.”
Dennis Ernst, MT(ASCP), NCPT(NCCT) (above), Director of the Center for Phlebotomy Education, shared his expertise during a recent webinar hosted by Dark Daily. Ernst considers blood culture contamination to be among the “low-hanging fruit” in every medical laboratory that can be easily and permanently corrected with the proper approach. (Photo copyright: Dennis Ernst.)
Ernst, a medical
technologist and educator, has seen the
difficulty in lowering contamination rates in a decentralized,
multidisciplinary workforce. He has worked for more than 20 years advocating
for best practices in the diagnostic blood collection industry and has helped clinical
laboratory facilities achieve a 90% reduction in their contamination rates. Ernst considers blood
culture contamination to be among the “low-hanging fruit” in every laboratory
that can be easily and permanently corrected with the proper approach.
“One statistic we’ve heard over and over again is that the American Society of Microbiology established the ‘threshold’ for blood culture contamination to be 3%,” Ernst said. “I believe strongly that a 1% contamination rate or less is what should be required and that it’s not only achievable, but sustainable.”
Regardless of
staffing mix, blood culture contamination is a common problem in the emergency
department, Ernst explained during his presentation, “Evidence-Based
Technology to Reduce Blood Culture Contamination, Improve Patient Care, and
Reduce Costs in Your Clinical Lab or Hospital,” which is available
free for streaming.
Improving Patient Care and Reducing Avoidable Costs
With unnecessary
antibiotic use, increased length of stay, and the cost of unnecessary
laboratory testing at issue, hospitals are tracking blood culture collection
results and exploring ways to reduce episodes of blood culture contamination. On these and other healthcare quality
improvement aims, providers are publishing study results on contamination
reduction and potential direct and indirect hospital cost savings. For example:
At the University of Nebraska, a
prospective, controlled, matched-pair clinical study showed an 88% reduction in
blood culture contamination with a 12-month sustained rate of 0.2% when
Steripath was used by phlebotomists in the ED. The author estimated the institution
would save approximately $1.8 million if the technology was adopted
hospitalwide, reported an article in Clinical
Infectious Diseases in July 2017.
Florida-based Lee
Health system’s microbiology laboratory reported an 83% reduction in
contamination rates comparing their standard method to ISDD for a seven-month
trial period. Their systemwide potential cost avoidance estimates ranged from
$4.35 million to nearly $11 million, reported an article in the Journal of Emergency
Nursing in November 2018.
Researchers from Massachusetts General reported that
ISDD is the single most effective intervention so far explored for reducing
costs related to false-positive blood cultures, potentially saving the typical
250- to 400-bed hospital $1.9 million or $186 per blood culture and preventing
34 hospital-acquired conditions (including three C.
difficile cases). The recent article “Model to Evaluate the Impact of
Hospital-based Interventions Targeting False-Positive Blood Cultures on
Economic and Clinical Outcomes” in the Journal
of Hospital Infection explains more.
Blood Facilities Should be Tracking Their Contamination
Rate
One of the biggest challenges faced during blood sample
collection is making sure an organism is not inadvertently introduced into the
blood. Therefore, importance has been placed on clinical laboratories and other healthcare providers
developing policies and procedures to limit the introduction of likely
contaminants.
“I believe most places monitor blood culture contamination,
but they are not doing much that is effective to reduce it,” Ernst said.
“That’s a real problem.”
To assist healthcare providers in blood culture quality
improvement, the free webinar, “Evidence-Based Technology to Reduce Blood
Culture Contamination, Improve Patient Care, and Reduce Costs in Your Clinical
Lab or Hospital,” available on-demand through Dark Daily, can be
downloaded by clicking here,
or by pasting the URL “https://darkintelligenceprogramsondemand.uscreen.io/programs/evidence-based-technology-to-reduce-blood-culture-contamination-improve-patient-care-and-reduce-costs-in-your-clinical-lab-or-hospital”
into a web browser.
This program, which polled more than 200 healthcare
professionals, explores the clinical and economic significance of blood culture
contamination, the downstream impact of false-positive blood cultures, and case-study
evidence of sustained reductions in contamination.
Both the clinical laboratory and the pathology laboratory have cut TAT and error rates
It is perfect irony that the Department of Pathology and Clinical Laboratory Medicine at the Henry Ford Health System is among the most effective Lean practitioners in the world of medical laboratory testing. That’s because Lean techniques were developed by Toyota Motor Corporation, which itself based its Lean management methods on its study of Henry Ford’s groundbreaking innovations at his auto manufacturing plant in Detroit.
Thus, the current use of Lean methods at the clinical laboratory at Henry Ford Health System means that these management tools have come full circle. Today, the laboratory at the hospital in Detroit that bears Ford’s name has adopted methods used in auto manufacturing to improve the lab’s processes. (more…)
Informed by the Lean methods of the Toyota Production System, innovators at the University of Pittsburgh Medical Center (UPMC) have created a clever and unique “smart hospital room.” Walking into a UPMC smart hospital room is like walking into healthcare’s future.
Upon entry of the caregiver into the patient’s room, a screen by the patient automatically shows the caregiver’s name, role, and, after a HIPAA privacy step, the caregiver immediately views relevant clinical information. At the same time, when anyone enters or leaves the room, a small spotlight highlights the hand sanitizer station on the wall-a subtle reminder that the individual should clean her or his hands. The screens are designed to present exactly the information each caregiver needs for that visit, and includes known allergies, medications, and necessary clinical actions. Because the screens are voice-activated, the caregiver only needs to speak to have the patient health record (PHR) show the requested information.
The effort to create the smart hospital room started in 2006, after a patient with a known latex allergy was touched by an IV nurse and suffered a severe reaction. The angry patient, with a swollen, puffy arm, even threw a bowl of soup at someone in the room. “The fact is we, as an organization, made it easy for her (the IV nurse) to fail,” observed David Sharbaugh, Senior Director of the Center for Quality Improvement and Innovation at UPMC. Sharbaugh led the effort to create the smart room. Studying the source of errors caused the improvement team to focus on caregiver’s access to information. “Electronic health records and medical information are, in a large part, cooped up in computers located at different strategic locations throughout the unit,” observed Sharbaugh. “All we are trying to do is to make that information accessible without adding extra work for the caregivers and the patient.”
Following the success of the first prototype smart room at 486-bed UPMC Shadyside Hospital, a total of 24 hospital rooms in the same ward were converted to smart rooms by this summer. Clinical patient information comes from an electronic medical record (EMR) by Cerner Corporation (NSDAQ:CERN) of Kansas City, Missouri. UPMC clinicians wear ultrasonic tags, about half the size of a pager, made by Sonitor of Olso, Norway.
Lab managers and pathologists will find it interesting that phlebotomists are one of five types of positions wearing the ultrasound tags. Other positions wearing ultrasound tags include: physician, nurse, nurse’s assistant, and host (who brings the patient into the room and is responsible for transport and dietary work).
For those wanting to learn more, Lucy Thompson, R.N., MN CCRN, Improvement Specialist, UPMC Center For Quality Improvement and Innovation, will present the story of the UPMC Smart Hospital Room and Lessons Learned at the upcoming Lab Quality Confab on Quality Management in Diagnostic Medicine. Lab Quality Confab will take place from September 24-25, 2008 at the Hilton Hotel in Atlanta, Georgia. More than 50 sessions and topics will cover the full range of laboratory and pathology operations, ranging from specimen collection and courier logistics to using Lean with automation in the high-volume core laboratory. Poster sessions will take place, and national awards and prizes totaling $6,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit http://www.labqualityconfab.com.
