A root cause analysis is being performed into a series of medical errors and transportation snafus that cost an airman his legs. The story in the Air Force Times details how mistakes in a “routine” surgery became a sentinel event. Here’s the link to the story:
Dennis Osmer is a TapRooT® Instructor from Georgia. He also is a Health, Safety & Emergency Management Consultant who advises companies on pandemic preparation.
Below are the latest e-mails from Dennis about the 2009 H1N1 pandemic flu virus and 2009 USA flu shots.
Dear Friends –
This novel H1N1 is not going away from the northern hemisphere and the activities in the southern hemisphere are off scale.
STATISTICS
The US now has 40,617 cases, with 263 deaths, in 55 states & territories (http://www.cdc.gov/h1n1flu/update.htm) — keep in mind that WHO & CDC only report cases that are confirmed in approved laboratories and in many areas, routine testing has been reduced — actural cases are much higher.
WHO has announced that the H1N1 influenza pandemic has “spread internationally with unprecedented speed” and that further international spread is unstoppable — they have stopped publishing laboratory confirmed case numbers as it’s become almost unmanageable, and will shift focus to mitigation.
ANTI-VIRAL MEDICATION
Several cases on Tamiflu resistant swine flu have been reported, but these are isolated.
Britain has launched a unique phone service to supply antivirals — using this phone service, individuals will get a reference number that can be used at a pharmacy to collect the medication.
VACCINE
CDC & HHS have announced priorities for vaccination (when available)
- students & staff in schools (K-12)
- children & staff in child care centers
- pregnant women
- non-elderly adults (age < 65) with medical conditions
- health care workers and emergency personnel
Vaccine production has hit a snag — 2 manufactures (Novartis & Baxter) report that yields are 30 to 50% of seasonal flu production — while initial batches may be available in mid October, full quantities could be significantly delayed — some clinical studies have begun on individual vaccines & the combination of the swine flu & seasonal flu vaccinations — the US government has granted liability immunity to all vaccine manufacturers for the H1N1 vaccine.
While there may be some vaccination available by mid October (more likely November), there won’t be enough for all — it’s likely that vaccinations for the general public won’t be available till February or so.
GLOBAL SPREAD
NEW ZEALAND
The flu activity in New Zealand has reached a 12 year high point, and the season hasn’t peaked yet.
ARGENTINA
Argentina had been reluctant to implement school closings, etc. — now that elections are over, they are extending winter vacation (up to a month) and urging people to avoid crowds — however, this is late, and may not have a positive effect — Argentina only trails the US & Mexico for the highest number of flu related deaths (137) — last week, over 5,000 surgeries were postponed to free-up hospital beds.
MEXICO
According to WHO, Mexico deserves thanks for its forceful, costly, and very public response — the closure of multiple public facilities, effectively imposed social distancing — this slowed the spread, while giving the rest of the world an early warning.
NOVEL H1N1
While the mortality is lower than seasonal flu, research is showing that the novel H1N1 causes more serious lung disease than seasonal flu strains — the virus can replicate at airway temperatures — seasonal flu typically infects the throat & upper respiratory passages, but the novel H1N1 also attaches to the lower part of the respiratory system — it reproduces internally (lungs, throat, etc.) at a higher rate than seasonal flu — it can cause severe respiratory illness, profound lung damage and even death in patients with no underlying medical conditions — in some locations, ventilator availability is becoming an issue — there appears to be a sub-population of relatively young people who very rapidly develop sever illness with this virus, requiring intensive ventilator support.
Transmission around the globe is not slowing — places where people are close together are a special concern (summer camps, prisons, academies, athletic events, cruse ships, etc.) — H1N1 is the dominant strain in the southern hemisphere now, and it’s anticipated that it will be the dominant strain in the northern hemisphere in the fall — the expected infected rate is 30% (seasonal flu is typically < 20%) for the next wave.
COMMENTARY
The lack of mass media attention is a concern — the White House has made an announcement & is proceeding with “behind the scene preparations” — they are expecting a very bad flu season this fall — the outbreak seems to be accelerating in the southern hemisphere and likely foretells what will happen in the northern hemisphere this fall — given that vaccinations may not be widely available till next spring, we will need to depend on non-pharmaceuticals interventions(handwashing, social distancing, masks, etc.).
And here is his update on flu shots for the USA this autumn…
Dear Friends –
Vaccine for seasonal flu approved in the United States.
The United States Food and Drug Administration (FDA) announced that it has approved a vaccine for the 2009-2010 influenza season. Authorities have made it clear that this vaccine will not provide protection against the 2009 H1N1 pandemic flu virus. However, health experts say that it is still important for individuals in the “at risk groups” to receive the latest seasonal flu vaccine. Each year experts from key organizations study the influenza virus from samples collected from around the world. They also analyze the global flu trends to identify which strain should be included in the seasonal vaccine for the new season. Click here to view the FDA press release.
Don’t be confused — this is the official, bureacuratic announcement that the standard seasonal flu vaccine has been released — the more critical swine H1N1 vaccine is still some time away — nevertheless, you should plan on getting the standard seasonal flu vaccination as soon as available (should be September for most communities in the US).
For his efforts to improve patient safety including the 1999 report, “To Err is Human, Building a Safer Health System,” Dr. Lucian Leape has been awarded the first Nightengale & Codman Patient Safety Award. We would like to add our congratulations.
In the 1999 report, Dr. Leape estimated that up to 98,000 people per year are killed in US hospitals due to medical errors. That estimate caused considerable controversy because before that report, no one had published an estimate of the total number of hospital error caused deaths.
The 1999 report helped people focus on the need to improve patient safety and reduce medical errors. Something that had been an issue for years, but had not received national attention.
TapRooT® Users know that we started showing healthcare patient safety experts how to find the root causes of medical mistakes starting back in 1994. That was the year we held our first Summit Track targeted to help people improve patient safety and quality of care and reduce medical errors.
I remember the Summit especially well because we had a medical engineer from a hospital in Boston talk about errors caused by human factors issues with medical devices. After the General Session talk (he presented to everyone at the Summit - not just medical folks) a nurse that was in the audience came up to the speaker to chew him out for airing medical industry dirty laundry in front of a “non-medical” audience.
Let’s hope that even though the estimated death statistics haven’t changed much in a decade, at least our attitudes toward patient safety improvement has become enlightened and our efforts to reduce medical errors now have a much higher profile.
If you are interested in best practices to reduce medical errors and sentinel events, see the great sessions in the “Eliminating Hospital Sentinel Events Best Practice Track.”
To see the sessions click on the button for the track at this web page:
According to an MSNBC story, A surgery technician in Colorado traded her own “dirty” syringes filled with saline solution with ones filled with a powerful painkiller - Fentanyl. This may have lead to 6,000 people potentially being exposed to hepatitis C (nine have tested positive so far).
This certainly was not an “accident” but it would be defined as a sentinel event under JCAHO’s guidelines.
Combining a criminal investigation and a root cause analysis can be difficult, but it can be done. If you would like expert advice on how to do it, contact us and we will have you talk to our experienced criminal investigators with root cause analysis skills.
They can talk to you about coordinating with the police and working with criminal prosecutors.
“There must be much wider, and better, use of root-cause analysis, which is an investigative method that seeks to identify the underlying causes of an incident, with a view to preventing its repetition.”
“There are serious deficiencies in the undergraduate medical curriculum, Tomorrow’s Doctors, which are detrimental to patient safety, in respect of training in:
•clinical pharmacology and therapeutics;
•diagnostic skills;
•non-technical skills; and
•root-cause analysis.“
“The apparent paucity of effective root-cause analysis in the NHS, along with other potential drawbacks of self-investigation by NHS organisations, raises the question of whether there ought to be something akin to the Air Accident Investigation Branch for healthcare.“
“There are serious deficiencies in the undergraduate medical curriculum, which are detrimental to patient safety, in respect of training in: clinical pharmacology and therapeutics; diagnostic skills; non-technical skills; and root-cause analysis.“
We’ve had several people from the UK NHS come to TapRooT® Training. All had very positive comments. Perhaps it’s time for wider use of advanced root cause analysis in the UK health system?
Here’s what Marion Christiansen had to say about the 2008 TapRooT® Summit:
(click to play - WMV format)
Are you planning to attend in 2009 in Nashville, TN (October 7-9)?
If you need to:
- improve patient safety
- enhance industrial safety
- stop human errors
- improve equipment reliability
- improve your root cause analysis
- benchmark performance and learn new best practices
- be inspired and motivated to continue your improvement efforts
You should be there!
Previous Summit attendees say they learned about those topics after attending past Summits. And this Summit will be better than ever.
Plus, this Summit comes with a money-back guarantee!
Attend the Summit. Go back to work and apply what you’ve learned. If you don’t get at least a 10 times return on your Summit fee investment, just send back your Summit materials and we will provide a full refund of the Summit fee.
See why past attendees have so many nice things to say and why many have returned year-after-year. See:
TapRooT® Summit attendees value our industry-specific best practice sharing sessions not only for the opportunity to learn best practices but also for the networking. Peer networking at the Summit, both socially (at our Reception) and professionally (in the best practice sessions) give attendees twice the opportunity to make long-lasting professional contacts. With all the demands on your time made by your professional and personal life, it’s good to know the Summit is also designed so you will have plenty of time to meet new people.
Networking is just the icing on the cake. Best practice sharing will help you solve many problems you deal with on a day-to-day basis. How is TapRooT® being utilized to promote best practices within the healthcare industry? How are root causes being tracked to evaluate effectiveness of investigations and corrective actions? Come prepared to discuss these and other issues as we seek to promote operational excellence in the healthcare industry.
Harry Wetz and Ed Skompski will be co-facilitators in the Healthcare Performance Improvement Best Practice Sharing session at the 2009 Summit.
Harry Wetz is the Patient Safety Officer and Director of Quality Management of INTEGRIS Health, Oklahoma City, Oklahoma. He is also the Chairman and member of the Board of Directors of INTEGRIS Federal Credit Union. He was a Fellow of Patient Safety Leadership/Fellowship at the American Hospital Association Health Forum. He has served as Chairman and member of the Respiratory Care Licensure Committee at Oklahoma State Board of Medical Licensure and Supervision, and as President of the Oklahoma Society for Repiratory Care. Harry is a graduate of the Respiratory Care Program at Rose State College.
LEARN MORE about the Eliminating Hospital Sentinel Events Track at the 2009 Summit here.
A Pakistan web site reported that an Australian scientist/virologist has hypothesized that the Swine Flu may have been accidentally produced in a lab while trying to make a flu vaccine for pigs.
If this proves to be true … Who will do the root cause analysis?
After reading a story yesterday about people setting up unsupervised home gene splicing labs, the whole deadly virus produced by accident scenario can really get spooky.
Rarely does something like this make the national news, but it happens more than you might think. Why? Doctors and Nurses are human, and they make mistakes the same ways and for the same reasons as machinists, factory workers, forklift drivers, pilots, you, and me. The question is, does the organization have the management systems and best practices in place to stop or minimize human error? Does the organization apply the knowledge they have effectively or do they seek outside knowledge to help them?
I’ve asked these questions for a reason; because human performance, best practices, and using knowledge are what the TapRooT® system is all about. Humans only work within the system we (management) provide and we owe it to them to develop and implement a system that works and to fix problems when we find them (or they find us!)
Dr. Daniel Ubani made a mistake. No doubt about it, he injected a patient with a fatal dose of a pain killer while making a house call. (Yes - they still do these in the UK.) David Gray, pictured below, died from the error.
Dr. Ubani was NOT intentionally trying to kill the patient (this wasn’t a premeditated homicide).
What do we do next?
Criminal prosecution!
Will this improve the system? You tell me…
The UK Guardian reported on the sentinel event. Read about the political response here:
One year later, I’m not sure there’s been action to fix “the system.” One person interviewed did say that they had removed the 100 mg bottles ofdiamorphine from the bags that doctors carry on house calls.
But have they addressed fatigue? The language issues? Doctor qualifications? What about the reasons why the patient hadn’t been treated for the kidney stones so that he wasn’t in pain (and didn’t require a house call)? No mention is made of any of these issues.
Instead, they are arguing about whether a criminal prosecution in Germany is adequate or if the Doctor should have been prosecuted in the UK.
The Hospital Survey on Patient Safety Culture: 2009 Comparative Database Report has an interesting statistic.On average, 52% of hospital staff surveyed did not report any medical errors in their hospital over a 12-month period. The statistic is based on data from nearly 200,000 hospital staff from 622 hospitals nationwide.
Can an employee really go a year without making any mistakes? Very doubtful. Even with outstanding human performance on an well designed action, a person will make a mistake one in 10,000 tries. More normal performance is one error in 1000 tries.
So what do these stats mean? That errors are largely under-reported.
Before you criticize the medical industry, look at your facility’s statistics. How many error reports did you have last year. How many employees do you have. I’d bet that more than 50% of your employees never report a single error.
Have you ever thought about the costs associated with these unreported, uncorrected errors? It many be more than you think. The problem with under-reporting is that cheap opportunities to improve performance (near-misses) are being missed. Only big errors (to obvious not to be reported) are acted upon. So you have to think not only of the cost of the small errors, but of the cost of the big problems that could have been prevented.
Would you like to improve your near-miss reporting? Then there’s a session by Kevin McManus at the TapRooT® Summit that you need to attend:
“8 Reasons Why People Don’t Report Problems &
8 Solutions to Improve Employee Involvement”
Learn why people don’t report problems and practical things that you can do to improve your error reporting program to make it world-class.
And if you would like to learn how to analyze and prevent human errors, attend theStopping Human Error Coursebefore the TapRooT® Summit on October 5-6. This course is being completely redesigned for 2009 (more about this in later posts) but we know that you will learn practical ways to make major improvements in human performance at your facility. I’ll send you the latest details if you e-mail me by clicking on the “Contact Us” button at the top of the page.
Next time you are busy justifying your accident prevention and root cause analysis efforts by concentrating solely on the monetary side of what an accident costs, read the story at this link:
TapRooT® instructors Tommy Garnett and David Davis will be presenting a 2-day Pre-Summit course, TapRooT® and FEMA for Healthcare Root Cause Analysis on October 5 and 6, 2009 in Nashville, Tennessee. TapRooT® Users will learn to use tools to perform JCAHO required healthcare FMEA as part of proactive risk reduction/performance improvement program.
Learn team-based, systematic, proactive approaches to identify how a process or design can fail, why it fails, and how to make it safer. These techniques can be applied to find and fix the root causes of issues to improve patient safety & stop healthcare sentinel events before they happen.
David Davis
Dave Davis is a Certified Nurse of the Operating room, and a Registered Nurse and retired U.S. Army Lieutenant Colonel. He has an MS in Nursing Services – Administration, and an MS in Operating Room Nursing. He is a previous consultant in infection control & disease epidemiology for the U.S. Army and is Certified as a DoD Healthcare TapRooT® Instructor.
Tommy Garnett
Tommy Garnett has 20 years of experience in Patient Safety & Risk Management. He is a Registered Nurse, a Certified Trauma Nurse, and a Flight Nurse. Tommy graduated from the American Institute of Medical Law, and is a licensed and Board Certified Healthcare Risk Manager. He is also Certified as a DoD Healthcare TapRoot® Instructor.
A patient suffering from pregnancy induced high blood pressure walks into an Acute Care Clinic 5 Day’s after giving birth with the following symptoms (1):
* Fatigue and weakness
* Rapid heartbeat
* Shortness of breath (dyspnea) when you exert yourself or when you lie down
* Reduced ability to exercise
* Persistent cough or wheezing with white or pink blood-tinged phlegm
* Swelling (edema) in your legs, ankles and feet
* Lack of appetite and nausea
* Difficulty concentrating or decreased alertness
The patient is sent home after a lung x-ray and with medicine to slow her heart rate down. Six hours later she is admitted to the Emergency Room by ambulance with the following symptoms (1):
* Fatigue and weakness
* Irregular heartbeat
* Shortness of breath (dyspnea)
* Persistent cough or wheezing with white or pink blood-tinged phlegm
* Swelling (edema) in your legs, ankles and feet
* Lack of appetite and nausea
* Difficulty concentrating or decreased alertness
The patient is dropped off at the front desk to answer questions because she is able to sit up and speak. Finally the patient is paralyzed in order to be examined and the staff realize that she is having Congestive Heart Failure.
Two heart stops later, admission to the ICU and after fiver years, my wife, Babette, is doing okay… still gets tired but she did not need a new heart nor did she receive brain damage from lack of oxygen.
So what does this have to do with Root Cause Analysis and what I teach today…..
There must have been something “Different” with this patient… There must have been a recent “Change” in how to diagnose Congestive Heart Failure….
We have talked about performing a Change Analysis before on this site and we teach this in our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader and Equifactor® Equipment Troubleshooting & Root Cause Failure Analysis courses…. but what if you do not find a recent Change or Difference, how could you have prevented this from happening?
While the initial thought may have been these were abnormal symptoms (A Difference)…. the symptoms listed above are pulled directly from a well known medical clinic (1). Staff are trained to look for these issues and no Change was made recently in their processes.
So could you have proactively prevented my wife’s missed diagnosis and the findings listed below?
“Multivariable analysis showed that patients who presented to the emergency department with acute cardiac ischemia were more likely not to be hospitalized if they were women less than 55 years old.”(2) So is AGE enough of a a patient difference to understand what went wrong on January 5th, 2004?
The only major difference between an audit finding and investigation finding is timing and the severity of the outcome! In all our TaprRooT® training courses proactive auditing is covered…. but what is the difference between a great audit and just watching someone work to see what policies and procedures they broke?
Go Out and Look (GOAL) and perform a robust audit. Knowing what you know now, what would you look for when auditing an examination of a patient in an Acute Clinic or the Emergency Room? Where would you start? What would you look for?
What critical Near Cause Categories could occur during this process in the timeline from Acute care clinic > ambulance > ER front desk ER > ICU (just to mention a few)…
Misunderstood Verbal Communication?
Turnover Needs Improvement?
No Communication or Not Timely?
Within each of these TapRooT® Near Cause Categories are Root Causes. So what would a Good Near Cause Category and Root Cause Best Practice look like…. the opposite of our definitions. By looking for these best practices during an Audit, you will find problems in you current unchanged process before it is too late.
So while performing an audit what is better and why… a surprise no notice audit or and a scheduled audit with plenty of notice…… I would love to see guests to the weblog and our TapRooT® students answer the above question.
After all The only major difference between an audit finding and investigation finding is timing and the severity of the outcome! Why wait! Join us and other leaders in the industry in an upcoming TapRooT® training course to learn more about effective proactive auditing. (more…)
The Process Excellence Leader is responsible for assuring that systems and processes are in place to promote and facilitate continuous improvement activities across the entire organization. Working under the general supervision of the VP of Quality and Process Excellence, the Process Excellence Leader is responsible for leading and implementing a large and diverse set of process and quality improvement projects and activities. The ideal candidate will also be a good listener, motivator, innovator, communicator, advocate, and have a passion for making significant improvements.
Dennis Osmer (one of our TapRooT® Instructors who also consults on Pandemic Flu) sent the following flu season update that I’m passing along to readers…
- - -
Dear Friends –
Seasonal Flu
This year there are higher rates of flu in Taiwan & in the EU, but lower rates in the US. Also, the dominant strain in the US is H1N1, but in Europe it’s H3N2, and in Canada influenza B is more common.
An article in “Emerging Infectious Diseases” (CDC publication) studied the use of face masks to control respiratory virus transmission in households and concluded the during a severe pandemic, transmission in households could be significantly reduced. Additionally, an article in the “American Journal of Infection Control” evaluated the performance of N95 masks after prolonged storage — the conclusion is that most respirators, shored for up to 10 years, will retain their performance.
An article in “Clinical Infectious Diseases” measured airborne influenza in a hospital emergency department, and concluded that there is evidence that influenza virus may spread though the airborne route.
An article in “Proceedings of the National Academy of Sciences” has found a link between influenza transmission rates and absolute humidity (with low humidity, influenza virus survival is prolonged and transmission rates go up).
VACCINE DEVELOPMENT
A team of researchers working in Japan’s Health Ministry have developed a new universal vaccine effective in many types of flu — trials in mice have shown promising results — but, human testing is still some time away.
WHO has announced it’s recommended composition for next year’s seasonal flu vaccine — while they considered including 2 influenza B viruses, they have stayed with the tradition of just one (though two virus types are known to co-circulate) — the recommendation (only changing the “B” part) is:
- A/H1N1 - similar to A/Brisbane/59/2007 - A/H3N2 - similar to A/Brisbane/10/2007 - B component - similar to B/Brisbane/60/2008
H5N1
China There have been 8 deaths (in 7 provinces) and several outbreaks in China so far this year — while the number sparked concern at WHO, there is no evidence of an epidemic — the cases were geographically scattered and sporadic. China is considered one the nations most as risk because it has the world’s biggest poultry population and many chickens are kept close to humans. Curiously, the Ministry of Agriculture states that it found no related, infected poultry. This could indicate another virus mutation which results in infected poultry with no virus symptoms.
Japan Panasonic has taken the unusual step of ordering some of the families of staff assigned to parts of Asia, Africa, eastern Europe and South America to return home (to Japan). The press release indicated that the move was based on H5N1 pandemic concerns, but did not elaborate. Honda has requested employees to cut down on trips to China.
Other A study, published in “Proceedings of the National Academy of Sciences” indicates that H5N1 is more virulent than the 1918 Pandemic strain. The H5N1 virus replicates faster and more widely in the lungs and caused a more intense inflammatory response.
Japan and New Zealand have announced plans to place their countries in quarantine should a pandemic occur.
Recent outbreaks have occurred in Vietnam, Egypt, and China.
While a dentist shouldn’t become a heart surgeon, some flexibility under extreme conditions is appropriate. They recommend following the National Incident Management System (NIMS) and using Incident Command, for an “all hazards” approach. Decision making during extreme conditions shifts the goal to the greatest good for the greatest number of individuals. This means that the “walking wounded” and the “worried well” might be unable to access medical care. This is endorced by ANA & the Joint Commission. It also allows for utilizing volunteers (based on their training) and provides for some ethical principles in emergency care — e.g. - individual privacy may be overridden during emergency conditions. - actions that impinge on individual liberty may be required, but should be clearly explained.
WHO data, below, shows an increase in the number of cases (now over 400) and deaths(256). Keep in mind that this is only data verified in WHO labs & that Indonesia is still withholding information.
I’m still convinced it’s smart to be informed and prepared.
Best Regards
Dennis
Dennis Osmer Environment, Health, Safety, & Emergency Management 678-333-4230
Like
