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Striving for patient safety NOW

NEWS

Patient reporting site for medical errors is now online!

New book by Rosemary Gibson "The Treatment Trap"

Malpractice Insurance for Patients

Report finds 9,400 serious errors at N.J. hospitals, Oct 15 th 2009

Incidence of adverse events in Swedish hospitals: published June 2009.

Blacklisting patients.

Report Conference vicitims of medical errors, April 23rd 2008 Utrecht Netherlands

Conference in the Netherlands to improve the position of victims of medical errors, 23rd April 2008

February-March 2008 :Information on the progress of the Tell and Repair legal provision:

Developments Tell and Repair legal provision September -December 2007

Breaking News:finally acknowledgement nil follow-up care to victims of medical errors 6th Sept. 2007

Summer Actionplan: direct measures to reduce medical errors, July 2007.

Tell and Repair proposal for legal provision, June 2007.

Manifesto 2007 Year of and for Victims of Medical Errors

Medical errors and medical records, proposal March 2007

2007: YEAR OF AND FOR VICTIMS OF MEDICAL ERRORS!

Patient safety terminology.

Survey of medical errors: epidemiology 2006

Clinton-Obama proposal for Malpractice Reform

Refusal of Disclosure

Harvard Consensus Statement

Patient reporting site for medical errors is now online!

The Empowered Patient Coalition

Dear Friends,

The Empowered Patient Coalition is pleased to announce that a new survey for reporting adverse medical events is now permanently online at report. This survey is designed by patients, for patients, in order to give people who have experienced adverse medical events a place where their reports can be counted.

Created in collaboration with Consumers Union Safe Patient Project, the survey aims to provide a snapshot of medical harm as it is lived by those who undergo it, beginning with the patient's initial procedure or treatment and continuing all the way through the patient and family experience of the legal system. Responses will be presented in de-identified, aggregated form at www.empoweredpatientcoalition.org.

This is an international survey. Reports will be displayed by country, and reports from the US and Canada will also be tallied by state or province whenever the respondent provides such information. Survey participants will also have the option of sharing their stories with the Consumers Union Safe Patient Project. In order to protect the confidentiality of patient information, we do not collect IP addresses or contact information unless it is explicitly provided by the respondent. It is our hope that this may allow the recovery of some small part of the patient safety information that is now lost to confidentiality clauses in medical settlements.

We envision this survey as a community project, and we welcome your input and participation. We hope you will forward the survey to your members and contacts, and ask that you link to it directly from your website or Facebook page if at all possible. Broad dissemination is the only way we can collect enough information to determine the trends we are hoping to be able to see. Buttons for linking to the survey can be found at
survey

With kindest regards,

Julia and Helen

New book by Rosemary Gibson "The Treatment Trap"

Disruptive Women in Health Care

Stop Running Red Lights AND Pay for Health Care Reform

By Rosemary Gibson | February 1st, 2010

Klik hier met de rechtermuisknop om afbeeldingen te downloaden. Om uw privacy te beschermen, is het automatisch downloaden van deze afbeelding van internet verhinderd. stop-running-red-lights-and-pay-for-health-care-reform

With all the hand wringing about health care costs, it is possible to cut costs without harming patients. Even better, costs can be reduced while making patients better off. Here’s how.

An unspoken truth is that three kinds of medical treatment are provided in the U.S. The first is treatment whose benefit is unquestionable. Surgery to treat a ruptured appendix is an example. Without it, death from life-threatening infection is almost certain. The life-saving medical care being rendered to earthquake victims in Haiti is in this category.

A second type of treatment is provided when uncertainty exists about benefits and risks. Doctors and their patients must balance the benefits and risks. The recent mammogram controversy fits into this gray zone.

The third type of treatment is when the possibility of harm exceeds the possible benefit. A panel convened by the Institute of Medicine years ago called it “overuse”. This is the subject of my new book,The Treatment Trap.

Health care tests and treatments today are like the colors of a traffic light. Life-saving treatments flash green. Where uncertainty exists, the light flashes yellow. With overuse, the light flashes red and tells us to stop.

We don’t stop at red lights in health care. In fact, we run right through them. In a survey conducted by the American College of Physician Executives, eighty percent of physicians who responded said they were very concerned or moderately concerned about their physician colleagues overtreating patients to boost their income. Fifty-four percent said they were concerned about their peers admitting patients to a hospital to increase their bottom line. The survey respondents are in leadership positions in hospitals, medical practices and other health care organizations.

Overuse is the third rail of modern American health care. The medical establishment and politicians don’t want to touch it. One person’s overuse is another person’s payment for college tuition or a mortgage on a McMansion.

Here’s why we should touch the third rail. Overuse is not just about money. Ask Ron Spurgeon, a California millwright who had bypass surgery for non-existent heart disease along with hundreds of other people who had needless cardiac procedures at a California hospital. Ron survived. Not everyone does.

According to a Commonwealth Fund survey, about one-third of Americans say that have had tests or treatment they thought was unnecessary. A lot of people are falling into the treatment trap, it seems.

In the health care reform debates, a new commission was proposed along with a commitment to test options to reform the “do more get more” payment system. Why wait for a commission or payment reform to curb overuse? Right now we can begin eliminating tests and treatment that yield no benefit. Let’s start with Pap tests performed on the ten million women who are not at risk for cervical cancer because they have had a total hysterectomy and no longer have a cervix. Yes, it’s true.

Even better, we can stop paying for surgeries that expose people to great risk and confer no benefit. When the Rand Corporation and the Harvard School of Public Health asked expert doctors to provide a second opinion on coronary angiograms, which show whether the heart’s blood vessels are blocked, the doctors found that one-third of people who were recommended for heart bypass surgery did not need it. This is what happened to Ron Spurgeon. It is one of many examples of surgeries, tests and procedures that are overdone.

Democrats and Republicans are concerned about ballooning budget deficits. It is hard to think of a more sensible public policy than to stop spending money on medical treatments and tests that cause more harm than good. It’s time to stop running red lights. It’s never good for your health.

Rosemary Gibson is the principal author of the forthcoming book, “The Treatment Trap: How Overuse of Medical Care is Wrecking Your Health and What You Can Do To Prevent It.” She led national initiatives to improve health care quality and safety at the Robert Wood Johnson Foundation for sixteen years.

Source

Malpractice Insurance for Patients

A new accidental death and disability policy will pay benefits to surgical patients if they have adverse outcomes following surgery.

Introduced by Surgical Risk Solutions L.L.C., Jacksonville, Fla., the policy is being sold as "complication insurance."

The contract, on which the firm says it has a patent application pending, provides $200,000 worth of financial protection for a premium of $80. Increased limits are available for a higher premium.

The contract pays in case of death or other serious adverse outcomes as specified in the contract, Surgical Risk Solutions says. The adverse outcome triggers include brain damage, loss of use of an arm or a leg, and permanent paralysis. The policy will pay whether or not medical error or fault is involved in a covered accident, the company adds.

Currently available in at least 9 states, the policy is underwritten by QBE Insurance Corp., Sydney, Australia.

Source

Report finds 9,400 serious errors at N.J. hospitals, Oct 15 th 2009

STATEHOUSE
BY SUSAN K. LIVIO

Hospital physicians, nurses and other medical workers committed nearly 9,400 "serious medical errors'' in 2007 that led to patients developing infections, blood clots and other conditions that threatened their health, a report released yesterday concludes.

The report, by the state Department of Health and Senior Services, is the first to reveal where mistakes occur, and how the public may use the information to shop for the best hospital care. Previous hospital "report cards" simply graded hospitals on the quality of their medical care and had no specific information about where and how often mistakes happen.

"Disconcerting numbers of preventable medical errors are occurring in our health facilities. Now consumers will know these results,'' said Patricia Kelmar, associate state director for advocacy for AARP-New Jersey, which pushed for the tougher reporting requirements. "Equally important, every hospital can see their own levels of mistakes compared to others, which we hope will encourage them to make the changes necessary to improve patient safety throughout the state."

Collectively, New Jersey's 72 hospitals committed more mistakes than the national average in how frequently surgical patients developed an infection and how frequently their surgical wounds "split open,'' according to the report.

"By publicly reporting hospitals' scores, we encourage all hospitals to improve care,'' said Health Commissioner Heather Howard.

New Jersey hospitals committed as many or fewer errors than other hospitals nationally in 10 other areas, including leaving an instrument inside a patient during surgery; accidentally puncturing an organ; giving the wrong blood type; injuring a mother or baby during a vaginal delivery; and failing to prevent hip fractures, punctured lungs, bleeding after surgery and blood clots in the lungs and large veins.

On quality, the report card judged how hospitals responded to patients suffering a heart attack and heart failure, battling pneumonia and undergoing surgery. Only one hospital scored the highest score of 100 in all four areas: Hackettstown Regional Medical Center in Warren County.

"It takes an entire team, not just one individual, to make quality a priority,'' Hackettstown Regional Medical Center President and CEO Gene C. Milton said. "This is something our hospital looks at closely.''

St. Barnabas Medical Center in Livingston is an example of how one facility could perform exceptionally in some areas and below par in others.

St. Barnabas made more mistakes than the national average in four of the 12 patient safety measures: accidentally puncturing an internal organ, causing injuries to mother and infant during a vaginal delivery, puncturing a lung and failing to prevent blood clots in the lung or large veins.

But in measuring quality, Saint Barnabas achieved perfect scores of 100 in treating heart failure and heart attacks, and ranked in the top 10 percent for providing surgical care.

The report is an important exercise for hospital executives and employees to demand more of themselves, said Fred Jacobs, executive vice president for the Saint Barnabas Health Care System and director of its Quality Institute.

"It's important for hospitals to develop an environment of quality,'' said Jacobs, a former state health commissioner who sat on a committee that designed the report. "The corporate board has given the direction that we will be in top 10 percent of hospitals,'' Jacobs said.

AARP'S Kelmar said matching the national rate in mistakes is not good enough. She noted there were 63 incidents statewide of a foreign object left in the body after surgery -- a rate that is about the national norm.

"The expected rate of occurrence for this incident is zero,'' Kelmar said.

Susan K. Livio may be reached at (609) 989-0802 or slivio@starledger.com.

Read the Report

Source:
http://www.nj.com/news/ledger/jersey/index.ssf?/base/news-15/125556570591030.xml&coll=1

Incidence of adverse events in Swedish hospitals: published June 2009.

The incidence of adverse events in Swedish hospitals: a retrospective medical record review study
Michael Soop1, Ulla Fryksmark1, Max Köster2 and Bengt Haglund2
1 Department for Supervision of Healthcare Services, National Board of Health and Welfare, Stockholm, Sweden
2 Centre for Epidemiology, National Board of Health and Welfare, Stockholm, Sweden.
International Journal for Quality in Health Care Advance . Public access online on June 25, 2009

Address reprint requests to: Michael Soop, Department for Supervision of Healthcare Services, National Board of Health and Welfare, 10630, Stockholm, Sweden. Tel: +46 701623328; Fax: +46 752473555; E-mail: michael.soop@socialstyrelsen.se

Abstract. Download the full article here
Objectives. To estimate the incidence, nature and consequences of adverse events and preventable adverse events in Swedish hospitals.
Design. A three-stage structured retrospective medical record review based on the use of 18 screening criteria.
Setting. Twenty-eight Swedish hospitals.

Population. A representative sample (n = 1967) of the 1.2 million Swedish hospital admissions between October 2003 and September 2004.

Main Outcome Measures. Proportion of admissions with adverse events, the proportion of preventable adverse events and the types and consequences of adverse events.

Results. In total, 12.3% (n = 241) of the 1967 admissions had adverse events (95% CI, 10.8–13.7), of which 70% (n = 169) were preventable. Fifty-five percent of the preventable events led to impairment or disability, which was resolved during the admission or within 1 month from discharge, another 33% were resolved within 1 year, 9% of the preventable events led to permanent disability and 3% of the adverse events contributed to patient death. Preventable adverse events led to a mean increased length of stay of 6 days. Ten of the 18 screening criteria were sufficient to detect 90% of the preventable adverse events. When extrapolated to the 1.2 million annual admissions, the results correspond to 105 000 preventable adverse events (95% CI, 90 000–120 000) and 630 000 days of hospitalization (95% CI, 430 000–830 000).

Conclusions. This study confirms that preventable adverse events were common, and that they caused extensive human suffering and consumed a significant amount of the available hospital resources.

Keywords: adverse events, medical record review, patient safety, risk management

Blacklisting patients.

Blacklisting Patients :www.patient-safety.com
This is another issue routinely mischaracterized by the medical community.
It is not about maintaining a list. But since the discussion of this issue is in its infancy it easily is mischaracterized.

Physicians assume a basic level of honesty from their peers. And expectations influence perception. They do not anticipate sins like rape from colleagues and the deliberate obfuscation of such. This allows the white wall of silence to be turned into a black one with nothing more than a phone call or a nuance in a referral.
Doctors, like members of any normal group, watch out for each other. If a patient never pays bills, or repeatedly files lawsuits, or habitually becomes violent, or travels around trying to get illegal prescriptions, one would expect a doctor who knew about it to warn colleagues.* But that kind of communication can result in blacklisting patients who need treatment.
A patient being blacklisted can go from doctor to doctor without getting diagnosed or treated and never know why. Blacklisting can result in permanent harm or even death and can be criminally illegal. What are the odds of the police pursuing it? Near zero. How is a patient who figures out that it is going on to persuade anyone of it? Where will be the proof? Doctors create the record. And the records are created to protect doctors, not patients (see defensive documentation). The police don't even know where to start looking. And state medical boards are run by other doctors to whom this looks like business-as-usual. The very suggestion of having been blacklisted will "strain credulity."

Overtness
It is not always subtle. Sometimes it is one physician blatantly telling another physician to find nothing wrong with a patient, to give no tests that could uncover injuries, and no referrals that could help the patient because anything found could indict a fellow physician.
Why would a physician risk his license and intentionally ruin the life of a patient? Well, there's really no risk. Who is going to report it? And who would believe the report? And who would do anything about it if they did? But still, what could be so awful that covering it up would be worth ruining the life of the patient? The statistics are elsewhere on this site about how many assaults, rapes and homicides are committed by healthcare workers each year against patients. Do you know why there are not a corresponding number of convictions for committing those crimes? One of the reasons is that no one in healthcare believes that their colleagues do these things, so they don't believe they are covering up anything. They simply refuse to find or record the injuries and/or evidence of the crimes. No record of it is created in the first place. And the patient doesn't get diagnosed or treated.
All it takes to blacklist patients is a hint that the patient might be making a case against a colleague. We patients cannot stop their gossip, and we cannot communicate among ourselves to overcome it without getting sued. All we can do is be aware that it is a problem, recognize that this is an unconscious routine for them, and fight for the right to speak, complain and seek help, protection and oversight.
Doctors are supposed to consider the seriousness of the malady,
not the virtuousness of the patient.
Medicine is not like other professions. The consequences for its customers are too great. Doctors are supposed to treat villains as well as heroes, even if treating them enables villains to commit more villainy. But they don't. If you were to go to your primary care physician with wounds received when one of his colleagues raped you, your primary care physician would diagnose you as being crazy, and so would every other physician you went to. When you hear in the news about a patient who finally lashes out in frustration, the medical community unites in diagnosing the patient as being paranoid and crazy, and journalists always accept that without question. After all, the pronouncement has been made by physicians. Why would anyone question it?
The healthcare industry is a monopoly as much as the water company or an electric utility company and has similar obligations. If power and water utilities refused service to someone, at least the victims would know that they had been cut off. Patients who are manipulated out of care without their knowing it, or even when overtly declined it, are left in a more sinister darkness.
Referral from a physician to a radiologist:
"Re: John Smith. This 57-year-old builder is requesting a CAT scan on his lumbar spine to be performed on a private, fee-paying basis. Mr. Smith is a malcontent of the highest order and holds a very warped view of life . . . expresses contempt for orthopedic surgeons, chiropractors, osteopaths, acupuncturists . . . "
from "The World's Worsts" by Les Krantz & Sue Sveum

Report Conference vicitims of medical errors, April 23rd 2008 Utrecht Netherlands

Report Conference Victims of Medical Errors, April 23 2008 Utrecht Netherlands.

April 23rd 2008 the medical field organised the first national conference for victims of medical errors. The Dutch Association of Hospitals, (NVZ) representing 100 hospitals, the Association of Medical Consultants, (OvMS) representing 16.000 physicians and the Association of Nurses and Caregivers (VenVN), representing 200.000 nurses and caregivers were present as well as consumers, patients and victims organisations.
The conference was organised as a result of strong pressure by SIN-NL and the IEU-Alliance. This was acknowledged by all present.

These are the results of the conference:
The Chair of the meeting Ms Marian Kaljouw Ph.D. Chair of the Nurses expressed her deep shame about the fact that the medical field so far does not or almost does not give care to victims of medical errors. The NVZ and the OvMS did not contradict this statement and were silent.
We compliment Marian Kaljouw with her honest and courageous statement.
The entire meeting was and acknowledgment of the horrible situation of victims of medical errors and their relatives.
The consumers, patients and victims organisations proposed the following:
-the immediate release of honest information
-the immediate arrangment of adequate remedial medical care to limit the damage.
Both represent the essence of the legal provision Tell and Repair of SIN-NL/IEU-Alliance.
-the immediate release of the medical records to the victims and their relatives
-SIN-NL/IEU-Alliance proposed to give a copy immediately after each consultation to the patient in order to enable them to approve the contents. Thus incomplete or incorrect records can be prevented, as mentioned in the NIVEL report of 2007.
-to oblige physicians, nurses and hospitals to learn from their errors.
-the Council of the Disabled and Chronically Ill made a remarkable proposal to install instantaniously a high fine on the refusal of honest information and remedial medical care. They also pleaded for a more active and efficient attitude of the Inspectorate of Healthcare. We certainly do agree with both proposals.
-the Consumersfederation pleaded for more transparency and publishing of medical errors, including those who are sent to the Inspectorate of Healthcare. We support this.
It was acknowledged that medical assistance to the present victims of medical errors has to be organised short term and that one should not wait for guidelines or laws.
We do regret that the medical field so far refrained from formulating their reaction to our legal provision Tell and Repair which has been signed by the Inspectorate of Healthcare and which has been approved by the lawyer J.Legemaate of the Dutch Association of Physicians and will be dealt with by the Ministry of Healthcare in the preparation of the new law Client and Quality of Care.
We emphasized that the rendering of honest information and remedial medical care is part of the regular and legal obligations of physicians and nurses. Therefor the use of the word aftercare was abandoned.
Within four weeks another meeting will be organised to develop a practical plan to improve the situation of the present and future victims of medical errors and their relatives. SIN-NL and the IEU-alliance were represented by Peter van den Berk and Sophie Hankes, and two members of staff.

Conference in the Netherlands to improve the position of victims of medical errors, 23rd April 2008

On the 23rd of April 2008 a major development for patient safety will take place in the Netherlands.
So far patient safety only focuses on the future, but now it will focus on the improvement of the position of the present and future victims of medical errors.
So far victims of medical errors are only met by the Wall of Silence and are usually abandoned by the physicians and their colleagues to cover up their errors.

The Association of Dutch Hospitals, which represents appr. 100 hospitals,
The Association of Medical Consultants, which represents appr. 16.000 medical consultants,
The Association of Nurses and Caregivers, which represents appr. 200.000 nurses and caregivers,
The Center for Nursing Expertise, the scientific division of the Nurses
Will organise an invitational conference for 5 organisations, of consumers, chronically ill and handicapped, consumers patients and patients-victims,
including the Iatrogenic Europe Unite-Alliance, www.ieu-alliance.eu to make an inventory of the wishes of victims of medical error about what should be done after the medical error.
This conference is the result of a common meeting of the above mentioned medical associations initiated by the IEU-Alliance in the Netherlands on the 7th of November 2007 to discuss the legal provision Tell and Repair, which the IEU-Alliance wrote and based on the Harvard Consensus Report 2006: When Things Go Wrong, Responding to an Adverse Event. Keywords of the legal provision are: honesty and openness, adequate follow-up diagnostics and adequate remedial medical care.
We will repeat our view that the Tell and Repair legal provision should be implemented as soon as possible, also due to the fact that physicians are ethically and professionally obliged to give honest information and good medical care.Furthermore the IEU-Alliance will focus on the need to record medical errors, to do research and to prevent medical errors.

February-March 2008 :Information on the progress of the Tell and Repair legal provision:

On the 13th of February 2008 the Dutch Ministry of Healthcare wrote:
- that they attach much value to honest information and remedial medical care to victims of medical errors
- that they would imply the Tell and Repair provision in their considerations in the preparation of the new law Client and Quality of Care, letter available.

On the 10th of March 2008 the Dutch Association of Hospitals, the Association of Medical Consultants and the Association of Nurses and Caregivers Netherlands wrote:
- that they will organise a conference on the 23rd of April 2008 to list the wishes of victims of medical errors and
- that the Tell and Repair provision will be formulated as an official NTA protocol at the end of 2008.

Certainly it is important that the need for improvement of honest information and respectful adequate treatment of victims of medical errors is acknowledged and subject of serious discussion. However we emphasize that sofar no actual progress has been realized. So far the improvement of the position of victims is only a matter of words and not action. It should be clear that many victims are in desperate need of actual medical assistance.
We stress the urgency of the situation and appeal to all active in healthcare to speed up the process to achieve true patient safety, not only for the future, but also and especially for the present.

Developments Tell and Repair legal provision September -December 2007

On the 19th December 2007 Nico Oudendijk Deputy Inspector General Inspectorate of Health Care has signed the Tell and Repair legal proposal in presence of John Kleijn, Dimitri.nu and Sophie Hankes SIN-NL / IEU-Alliance.

On the 7th of November 2007 the Association of Medical Consultants, the Association of Hospitals and the Association of Nurses and Caregivers in the Netherlands agreed to formulate a proposal before the 15th of March 2008 to improve the aftercare to the present and future victims of medical errors. They agreed to base the proposal on the Tell and Repair legal provision.

October 2007:
Meeting with Dutch Association of Medical Consultants and Dutch Association of Hospitals on Tell and Repair legal provision positive.

September 2007:
Acknowledgment by Association of Medical Consultants that follow-up care to victims of medical errors is nil.
IEU-Alliance proposes Tell and Repair legal provision

Breaking News:finally acknowledgement nil follow-up care to victims of medical errors 6th Sept. 2007

Acknowledgment that follow-up care of victims of medical errors is practically nil.
Institution of “Tell and Repair” legal proposal necessary.

The Dutch organisation of Medical Consultants openly acknowledged on the 3rd of September 2007 during a public debate organised by the Radboud University Medical Center in Nijmegen, Netherlands, that the follow-up care to victims of medical errors is practically nil.
This acknowledgment is of major importance.
In a meeting on the 6th of September 2007 with Chair Sophie Hankes LL.M of SIN-NL/IEU-alliance the deputee Inspector-General of the Dutch Health Inspectorate confirmed that physicians do not give honest and open information nor adequate follow-up medical care to victims of medical errors.
As the situation was so clear he did not deem it necessary to start investigations.
Oudendijk admitted that complaint-boards of hospitals do not deal adequately with complaints of victims of medical errors. He pointed out that in addition to the physicians and nurses, the leadership of the hospital is also accountable for medical errors.

Sophie Hankes requested institution of the “Tell and Repair” legal proposal in order to achieve that victims of medical errors would receive honest information and remedial medical care.
She also requested that surviving relatives would be informed in an honest and open way.
Deputee Inspector-General Oudendijk agreed to give his written support for the “Tell and Repair” proposal before the 1st of January 2008.

Moreover the Dutch organisation of Medial Consultants, the Dutch Association of Hospitals and the organisation of Nurses and Caregivers VenVN, as well as the Center of Nursing Expertise LEVV, have explicitly agreed to attend a common meeting with the IEU-Alliance to discuss improvement of the position of victims of medical errors.

Summer Actionplan: direct measures to reduce medical errors, July 2007.

The IEU-Alliance is aware that in spite of the extremely serious situation of medical errors and many of its victims, governments, politicians as well as professional medical organisations are taking their summer recess.
Therefore we call upon all professionals in healthcare to implement the following measures which will lead directly to LESS MEDICAL ERRORS and thus LESS VICTIMS.
We propose the following:

1. Washing of hands against spread of MRSA

2.Creation of correct medical records

3.Discipline improvement: strict implementation of protocols and agreements

4.Improvement of communication eg to obtain true informed consent

5.Direct follow-up of alarming results of laboratory or examinations eg CT/MRI

6.Arrangment of adequate aftercare after operation or after discharge from hospital

7.Implementation of Tell and Repair principle:
open, honest disclosure and repair of the damage of the medical error

Your reaction is welcome at: office@ieu-alliance.eu

Tell and Repair proposal for legal provision, June 2007.

Tell and Repair provision as extension of Laws on Medical Treatment Agreement.
June 2007, to be implemented as soon as possible, ultimately January 1st 2008.
Based on Harvard Consensus Report(2006) When Things Go wrong: Responding to Adverse
Events, discussed at workshop Position of the Patient by Sophie Hankes SIN-NL/IEU-alliance
Congress Blamefree Reporting, KNMG Utrecht, 24 November 2006.

What is the wish of a patient when he/she is damaged by a medical error? Put yourself in
his/her place: what would I want if I were hurt by treatment? What is the right thing to do?
Guiding principles concerning disclosure directly after the medical error:
1.Report only the facts of the error, what happened.
2.Give reliable information as soon as this is available.
3.Explain which follow-up diagnostics and remedial medical care are recommended.
4.Explain the implications for the prognosis

Open and full disclosure:
1.Tell the patient and family what happened.
2.Take responsibility.
3.Apologize.
4.Explain that the error will be examined.
5.Explain what will be done to prevent recurrence of the error.

Who and how to communicate:
1.A trusted caregiver should lead the initial communication.
2.The person responsible for next steps in care should lead subsequent communication,
possible in presence of person of choice of patient/family.
3.Include primary nurse in communication, if this is the wish of the patient/family.
4.Include member of staff with special communicaton skills.
5.Choose a quiet, neutral area for communication, not the room of the CEO.

Follow-up communication:
1.Conduct follow-up sessions promptly. Apologize in case of delay.
2.Physician who is responsible for care should lead sessions. Involve CEO in case first
communication was not successful.

Support and follow-up medical care for the patient, family and caregiver:
1.Take each patient/family concerns serious and be respectful.
2.Maintain the therapeutic relationship, provide appointments. Do not abandon the patient.
3.Put all billing on hold pending analysis of the event.
4.Investigate possible means for providing financial support and provide if necessary financial
compensation.
5.Provide if necessary psychological and social support.
.Provide if necessary psychological counselling for the physician/nurse who caused the error.

After the medical error the following is essential:
-honest and open information : what happened.
-follow-up diagnostics to determine the damage and follow-up remedial medical care to
mitigate or repair the damage.
-registration and examination of the error to prevent recurrence and to learn from errors.

Manifesto 2007 Year of and for Victims of Medical Errors

published on the occasion of the 50th anniversary of the European Union 25th of March 2007

In order to improve transparency and the quality of healthcare:
* Introduction of the “Tell and Repair” protocol based on the Harvard Consensus Report March 2006 to the benefit of victims of medical errors.

* Introduction of “Tell and Repair” protocol as well and patient safety in medical education as well as introduction of obligation for yearly attendance of post-graduate training for qualified physicians and healthcare professionals.

* Introduction of positive incentives for physicians, nurses and other healthcare professional to report medical errors to the national authorities and to inform patients about medical errors. Likewise introduction of sanctions against those who do not report nor inform the patients. Introduction of statutory reporting system, analysis and prevention system.

* Introduction of a National Reporting Center for victims of medical errors in combination with the installment of a National Independent Mediator who is qualified to interfere immediately on behalf and to the benefit of the victims of medical errors.

* Statutory obligation: medical records are only valid after written authorization of the patient.
* Sanctions for not providing full and correct medical records to patients at first request.
* Statutory obligation for healthcare insurers and physicians to provide the patients with the ICD-10 codes of their illness and to provide copies of all bills of physicians and hospitals.

* Statutory obligation to include representatives of victims of medical errors in discussions and decisions on medical errors, the victims and patient safety.

* Statutory obligation to offer mediation for medical errors in stead of legal procedures.
* Statutory obligation to offer no-fault system in stead of tort-system.

* Statutory obligation for the national Health Care Inspectorates in all EU-countries to record the status of doctors in EU-countries concerning verdicts of professional dysfunctioning and to make that information available for EU-citizens.

* Installment of truth commissions to investigate medical errors and the position of victims.

* Installment of national parliamentary inquiry per country as well inquiry of European Parliament to examine medical errors, the position of victims and patient safety in general.

- May these innovations improve the quality of healthcare to the benefit of all those involved -

Medical errors and medical records, proposal March 2007

Proposal for authorisation of medical records by the patient.

As acknowledged by Prof. Legemaate of the Royal Dutch Medical Association (KNMG) in his augural speech May 2006, Free University Amsterdam, physicians generally do not inform their patients about the occurrence of a medical error.
This implies that the medical records are often not complete or not completely correct, in order to conceal the medical error as much as possible.
For the patient/victim of the medical error it will thus be very difficult to prove the error.

Physicians also register-unjustly- often in the records that they informed the patient extensively or that the patient refused or requested certain examinations. Sometimes we even find derogatory remarks about the patient.

After the occurrence of a medical error, the patient/family members should request a copy of their medical records as well as the nurses records as soon as possible.

In order to avoid any misunderstandings or deliberate changes we plead to install a standard procedure for medical records:
-at the end of each consultation the physicians hands a copy of the report of the consultation in order to enable the patient to check and correct it.
-the report of a medical consultation is only valid and has legal status when the patient has put his signature of approval under it.
-likewise for all medical records by nurses and other healthcare professionals.
In addition: no correspondence without authorization( signature) of the patient.
Too often letters which contain incorrect information have been sent by physicians, assuming permission by the patient. No permission can be assumed automatically. No area of activities in our society permits professionals to write letters without the consent of the individuals involved. The privileges which the medical profession has assigned to itself are incorrect and have been unjustly obtained. Transparency requests prior consultation and authorization of/by the involved patient. All letters which a medical professional sends should be authorized by a signature of the involved patient.

2007: YEAR OF AND FOR VICTIMS OF MEDICAL ERRORS!

IEU-Alliance in co-operation with SIN-NL declares
2007 as the year of and for victims of medical errors.

Physicians, nurses, hospitals,risk- insurers, healthcare-insurers, Health Inspectorate, professional medical and hospital organisations, politicians and the media:
Take your responsibility:
-inform the victims of medical errors and/or members of their family fully and correctly
-give adequate follow-up diagnostics and remedial medical care to repair the damage
give continuity of care and give access to genuine medical care
-give respectful and timely financial compensation.

Above all: be open and honest to the victim and his/her members of the family according to your legal, professional and ethical obligations and
report medical errors according to your legal, professional and ethical obligations in order to ensure examination and analysis and to develop systems of prevention of medical errors.

We strongly plead to set up a parliamentary inquiry by the European Parliament and Truth commissions to examine the medical errors,acknowledge the damage and sorrow which has been caused to the victims and to formulate recommendations to prevent further unnecessary harm to future victims and their families.

Please send your email to office@ieu-alliance.eu with the text:
I support the year 2007 as year of and for victims of medical errors.

Patient safety terminology.

‘Patient safety’,’ hot’ and 'hype', ‘adverse event’, ‘incident’, ‘system failure’.

Those who study the literature about patient safety frequently come across new words and concepts which are used in a special, uncommon way.
Suddenly the word ‘Patient safety’ appeared and it is called ‘hot’ or described as a ’hype’. The meaning of ‘hot’ is actual and in. Hype can be defined as modern mania. It is quite remarkable to describe a large long existing social problem - medical errors which cause the death and disability of app. thousands of people a year- as ‘hot’ or a ’hype’.
Suppose you become disabled or a member of your family dies due to a medical error.
Surely you will be sad. Will you say: this has been caused by a ‘hot’ problem?
Who actually decided that patient safety applies only to ‘adverse events’- in normal language medical errors- in the future? Why do physicians want to boycott the use of the word errors?
Why does patient safety not apply to the present victims, who were confronted with a lack of patient safety in the past?
Why do the responsible professionals decide the definitions of their dysfunctional behaviour?
Which value do physicians attach to the suffering of their victims?
International research shows that 10% of hospitalisations results in medical errors, of which 1% results in death or disability: 1 in 1000 hospitalisations! This means medical errors are a structural problem. One can wonder whether it is justified to use the term ‘incident’.
‘Incident’ is defined as disturbing event and ‘incidental’ as less frequent and secondary. The word ‘incident’ minimises the seriousness of the event in which e.g. a fellow human being died or became disabled.
The use of the word ‘system failure’ is also doubtful. This word is used to place the responsibility at the system and denies the individual responsibility. A system is a set of procedures and individual activities. It is an abstract concept. Are physicians not human?
Individual activities, also by physicians are part of systems. Physicians have their own individual and personal responsibility.
The word ‘system failure’ does not occur in regular language. Apparently it is the product of creative brains of the so-called patient safety experts.
‘Patient safety experts’ prefer to ask only the question: why and wish not to address individual responsibility. In case of a medical error it is however important to address all issues:
What happened? When did it happen? Why did it happen?
Who was involved ( passive)? Who was involved (active)?
What is the consequence (damage)? Can the damage be repaired, how, by whom and when?

November 23, 2006 the theme of the conference of the Dutch platform patient safety was:
Repair and tell! (adopted from the Harvard Consensus Report: Responding to Adverse Events, March 2006) We support this completely.
Please use regular and understandable language. Physicians and hospitals: go ahead and provide genuine remedial medical care to the present victims of medical errors!
Medical errors are not ‘hot’ or a 'hype'. They are a long standing urgent problem.
Government, physicians, nurses and hospitals: address the problem of medical errors adequately and respectfully now!

Literature:
John Banja Medical Errors and Medical Narcissm, USA 2005
Nancy Berlinger After Harm: Medical error and the ethics of forgiveness, USA 2005
Van Dale Groot Woordenboek der Nederlandse Taal, NL (Dictionary Dutch Language).

Survey of medical errors: epidemiology 2006

Iatrogenesis third cause of death after heartdisease and cancer in the USA**

From data on Adverse Events in Healthcare given by the National Patient’s Safety Agency (NPSA) UK, 2005 * the average rate of medical errors across several countries in the developed world based on hospital admissions is estimated to be 10%. This figure is generally accepted as a reasonable estimate. Using this figure for medical error rate and extrapolating from calculations of the UK Medical Error figures the following table has been constructed. The Chief Medical Officer (UK) Prof. Sir Liam Donaldson stated in his Paper: ‘Organisation with a Memory’(2000) that it was estimated that 10% of patient hospital admissions in the UK would suffer a medical error ( 850,000 per year). This means that there were approximately 8 mill admissions to hospital in one year (representing 13% of population). Of these errors 1% would be very serious causing death or permanent injury ( 80,000). Estimated deaths in UK 34,000 per year and 40,000 seriously injured. It was decided to lower the expected number of hospital admissions to 10% of the population from 13% as in the UK, so that the data would not be overestimated. Using these percentage figures as a base the following can be extrapolated for Europe. We emphasise that the data have been extrapolated because there are no official data available.There is general consensus that many of the medical errors are preventable, possibly as many as 50 %.

*NPSA report Building a Memory:Preventing harm, reducing risks and improving patient safety, London July 2005 p.53

* ‘Quality in Australian Health Care Study’:
Med J Australia (vol 163,1995) by R. Wilson, W. Runciman & R.Gibberd
**Journal of the American Medical Association (JAMA) in an article(vol.284,nr 4, 2000) by
Dr B. Starfield estimated that deaths in the USA due to medical errors could be as high as
225,000 per year.
Other sources (‘ To Err is Human’,1999) puts deaths at 100,000 per annum)

In 2006 within Europe there is still no mandatory, official system of registration of medical errors. Nor is there mandatory root cause analysis; nor are there systems established to prevent the occurrence of medical errors. In comparison, motor vehicle accidents have been for decades routinely and systematically registered with the recording of deaths and injuries. For fear of litigation victims of medical errors usually do not receive follow-up genuine diagnostic tests or genuine remedial medical care***. This is unethical and inhuman. We are aware that various necessary initiatives in the area of Patient Safety and research into the occurrence of medical errors are being implemented in many countries throughout Europe. This is indeed a very positive development. However, top priority should be given to the organisation of remedial medical care for the innocent and suffering iatrogenic patient regardless of legal liability of the respective Health Institution.

***Bismark,M Paterson R. No fault compensation in New Zealand:harmonizing injury compensation, provider accountability and patient safety. Health Aff(Milwood)2006;25:278-83
Bismark,M Paterson R .”Doing the right thing”after an adverse event. N Z Med.J..2005 July 29; 118(1219):U1592

Copyright IEU-Alliance 2006

Clinton-Obama proposal for Malpractice Reform

Making Patient Safety the Centerpiece of Medical Liability Reform.

Senators Hillary Clinton an Barack Obama have introduced legislation, the National Medical Error Disclosure and Compensations(MEDIC)Bill (S.1784) to implement programs for disclosure and compensation. This model promotes confidential disclosure to patients of medical errors in an effort to improve patient safety systems. At the time of disclosure, compensation for the patient or family would be negotiated and procedures would be implemented to prevent a recurrence of the problem that led tot the patient’s injury.
The May 25, 2006 issue of the New England Journal of Medicine includes a Perspectives article by Senators Hillary Clinton and Barack Obama, which cites the University of Michigan Health System and the VA Hospital in Lexington, Kentucky as models for a new approach to handling medical errors and malpractice litigation. The New England journal has made the Clinton/Obama malpractice article available for free:
NEJM Clinton-Obama

Refusal of Disclosure

Editorial New York Times, September 9th, 2006
When doctors hide medical errors.

It’s probably no surprise that doctors a less likely to admit a serious mistake if they think they can get away with it than if they think the patient will find out. But now we have confirmation from a survey of some 2,600 doctors in the United States and Canada concerning what they would tell patients about serious medical errors in four hypothetical cases.
The doctors talked a good game — fully 98 percent endorsed the need to disclose serious errors to patients, according to survey results published in the Archives of Internal Medicine. But most had something less than full disclosure in mind. Only 42 percent would actually use the word “error,” while 56 percent would mention the adverse event but not the error, relegating the harm to the “stuff happens” category. Only 33 percent would explicitly apologize for their mistake.
If the error were apt to become obvious — say a sponge left in the patient’s body that required a follow-up operation, or an insulin overdose that required resuscitation and transfer to intensive care — the doctors were far more apt to admit error and apologize than if the error was too subtle for most patients to recognize. “Basing disclosure decisions on whether the patient was aware of the error is not ethically defensible or consistent with standards,” the authors admonish their colleagues.
The researchers are dubious that limits on malpractice suits would have much impact on what doctors admit. Changes in medical education to encourage disclosure of errors would surely help, as would computerized systems to detect errors that might otherwise remain unnoticed. As it is, doctors seem reluctant to provide what patients deserve and say they want: an explicit acknowledgment of error, information about why it happened, and an apology from their physician.

Comment:
fear of litigation is a strong impediment for physicians not to inform patients on the occurrence of medical errors. However, experience in a.o. the Veteran Affairs Hospitals and the University of Michigan Health System Hospital has shown that when honesty and openness are applied, patients are less likely to sue.
The Sorry Works Coalition (www.sorryworks.net) in the USA promotes
honesty by physicians and hospitals and the offering of apologies to victims/members of their family in case of a medical error. This approach will hopefully be adopted by all medical professionals and hospitals.

Harvard Consensus Statement

Spring 2006 the Harvard Hospital Group published the Harvard Consensus Statement:
When things go wrong: Responding to adverse events

This group consists of sixteen Harvard Teaching Hospitals.

The paper is organized in three major divisions:
1. The Patient and Family Experience
2. The Caregiver Experience
3. Management of the events.

Each section has three parts:
1. A brief summary of expert consensus about the issue
2. The reason and evidence behind consensus
3. Recommendations

The Harvard Hospital Group recommends to adopt the following principles:
- full, open and honest disclosure to the patient on the medical error and the damage
- providing genuine follow-up diagnostics and remedial medical care to mitigate the damage

This report is of major importance to the improvement of the position of victims of medical errors and patient safety. Therefore its recommendations should be implemented as soon as possible in Europe and globally.