Patient Safety - Reality Check

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Rate of Reporting Adverse Events
in Medicine

Below is a list of studies with summaries and links to them. They are from Health and Human Services, BMJ Quality & Safety, Journal of General Internal Medicine, American College of Physicians, and such like.

2% rate of accurate reporting found in this study by The United States Department of Health & Human Services (HHS)
An HHS Report in March 2010 found that reviewed hospitals did not generate incident reports for 93% of adverse events. The 7% of the time when they did generate reports, the information was inaccurate 63% of the time. Which means clinicians are willing to report accurate information about adverse events 2% of the time.

The summary is at this link: Reporting Never Events
A pdf of the full report is at this link:
http://tiny.cc/hhsNeverEvent

 

1.5% report rate of adverse events in this study
This fact is cited in:
Making Health Care Safer
A Critical Analysis of Patient Safety Practices
Prepared for:  Agency for Healthcare Research and Quality, Contract No. 290-97-0013
Prepared by: University of California at San Francisco (UCSF)-Stanford University Evidence-based Practice Center

"Most hospitals' incident reporting systems fail to capture the majority of errors and near misses. Studies of medical services suggest that only 1.5% of all adverse events result in an incident report and only 6% of adverse drug events are identified through traditional incident reporting or a telephone hotline. The American College of Surgeons estimates that incident reports generally capture only 5-30% of adverse events. A study of a general surgery service showed that only 20% of complications on a surgical service ever resulted in discussion at Morbidity and Mortality rounds."

From Chapter 4. Incident Reporting
Heidi Wald, M.D., University of Pennsylvania School of Medicine
Kaveh G. Shojania, M.D., University of California, San Francisco School of Medicine

The full report of the above was available on line for a few years at at http://www.ahrq.gov/clinic/ptsafety/chap4.htm, but now has been archived and will take some digging to access.

 

BMJ: Neither medical errors nor their costs are visible in the record.
Patients with known conditions were sent for treatment in order to measure the success of caregivers in diagnosing and treating the illnesses. 399 visits were made to 111 physicians in 14 locations.

Missed or unnecessary services cost approximately $174,000 of which only $8,745 was discoverable in the medical records. Important information about patients was entirely missing from medical records.

From an article by Alan Schwartz called Uncharted territory: measuring costs of diagnostic errors outside the medical record in BMJ Quality & Safety.
http://qualitysafety.bmj.com/content/early/2012/07/06/bmjqs-2012-000832.abstract

 

"Hospital Incident Reporting Systems Do Not Capture Most Patient Harm" is the title of a United States Department of Health and Human Services (HHS) report released in January of 2012. According to it, when Medicare patients are harmed in a hospital 6 out of 7 times hospital employees do not recognize or report it. That is not just events that could lead to harm not being reported. That is the actual harm not being reported as well.

Daniel R. Levinson, the inspector general of HHS, says that hospital employees do not recognize “what constitutes patient harm” or do not realize that particular events harmed patients. And when they do recognize harm they do not recognize that it should be reported. According to an interview in the New York Times (at this link), he said that in some cases employees assumed someone else would report the episode, or they thought it was so common that it did not need to be reported, or “suspected that the events were isolated incidents unlikely to recur.”

This is an expansion of awareness about why there is so little accurate reporting in medicine. Now if only Mr. Levinson could add an understanding of the extent to which people interpret the evidence of their senses in self serving ways, seeing the world differently than a disinterested third party would, making it so that people with conflicts of interest (like caregivers) never are reliable witnesses. And if after that there were some awareness of how self-interest rewrites memory (for instance, see this study), we might start developing solutions that address the fundamental causes of the problem.

It is Report (OEI-06-09-00091), dated 1-5-12. A summary is available from the HHS site at this link where there is a link to the PDF of the entire document.

 

Patient Reporting / Patient-Identified Events

0% of adverse were events reported in "What Can Hospitalized Patients Tell Us About Adverse Events?" in the Journal of General Internal Medicine
Among 228 patients admitted to the medical unit of a Boston teaching hospital, the patient-reported adverse event rate was nearly 9 per 100 admissions. Serious injuries were uncommon, but two thirds were judged preventable. In addition, 4% of patients experienced near misses. Few patient-reported incidents were identified in the medical record, and none were submitted by clinicians to the hospital's incident-reporting system.
The conclusion of the article was that inpatients can identify adverse events affecting their own care. Many patient-identified events are not captured by the hospital incident reporting system or recorded in the medical record. Engaging hospitalized patients as partners in identifying medical errors and injuries is a potentially promising approach for enhancing patient safety.
All 19 nurse respondents endorsed the statement that medical inpatients can identify problems such as errors and injuries, and that they should continue to be asked about problems, injuries, and errors experienced in the hospital.
A significant limitation of most studies is the ascertainment of adverse events based on chart review alone. Many adverse events are not recorded in the medical record, a finding attributed to variable standards for documentation, clinician unawareness or oversight, and concern about liability exposure.
A study in ambulatory care showed that chart review detected fewer than 11% of adverse drug events. . . patient contact represents an important detection approach.

From an article called "What Can Hospitalized Patients Tell Us About Adverse Events? Learning from Patient-Reported Incidents"
by Saul N. Weingart, MD, PhD, Odelya Pagovich, BA , Daniel Z. Sands, MD, MPH, Joseph M. Li, MD, Mark D. Aronson, MD, Roger B. Davis, ScD, David W. Bates, MD, MSc and Russell S. Phillips, MD
in the Journal of General Internal Medicine, Volume 20, Issue 9, 2005, pages 830-836
The abstract can be viewed at:
http://www3.interscience.wiley.com/cgi-bin/fulltext/118700875/HTMLSTART

 

Eight Years After IOM Report: Patient Reports are more Reliable than Hospital's
Daniel R Longo, ScD, Virginia Commonwealth University School of Medicine says that any study that does not take patient reporting into account is severely underestimating the extent of problems in the nation’s hospitals.
http://www.annals.org/cgi/eletters/149/2/100#97449

Janet Corrigan says that based on the research and knowledge that has accumulated since 1999 regarding root causes and systemic breakdowns, the IOM's initial estimate is “probably quite low.” She is president and CEO of the National Quality Forum and helped to author the Institute of Medicine report.

 

When negligence is involved, an adverse event is much less likely to be reported.
Annals of internal medicine ISSN 0003-4819, 2002, vol. 136, no11, pp. 812-816 (16 ref.)
Published by American College of Physicians, Philadelphia, PA,
http://cat.inist.fr/?aModele=afficheN&cpsidt=13705597
Authors: THOMAS Eric J. ; STUDDERT David M. ; BRENNAN Troyen A. ;
Authors Affiliations:
Brigham and Women's Hospital and Harvard School of Public Health, Harvard University, Boston, Massachusetts, Medical University of South Carolina, Charleston, South Carolina, University of TexasHouston Medical School, Houston, Texas,

Abstract
Background: The data used by the U.S. Institute of Medicine (IOM) to estimate deaths from medical errors come from a study that relied on nurse and physician reviews of medical records to detect the errors.
Objective: To measure the reliability of medical record review for detecting adverse events and negligent adverse events. Design: Medical record review.
Setting: Hospitalizations in Utah and Colorado in 1992.
Measurements: After three independent reviews of 500 medical records, the following were measured: reliability and the effect of varying criteria for reviewer confidence in and reviewer agreement about the presence of adverse events.
Results: Rates for adverse events and for negligent adverse events varied substantially depending on the degree of agreement and the level of confidence that was required among reviewers.
Conclusion: Estimates of adverse event rates from medical record review, including those reported by the Institute of Medicine in its 2000 report on medical errors, are highly sensitive to the degree of consensus and confidence among reviewers.


Patients Identify Undocumented Adverse Events
Telephone interviews with 201 patients after ED discharge identified 10 adverse events that had not been reported in their medical records. That is 5% of patients suffering adverse events with no record made of them.
— Kristi L. Koenig, MD, FACEP in Journal Watch Emergency Medicine September 26, 2008
http://emergency-medicine.jwatch.org/cgi/content/citation/2008/926/4


The Silence
by Michael L. Millenson
in Health Affairs, 22, no. 2 (2003): 103-112
http://content.healthaffairs.org/cgi/content/abstract/22/2/103
Millenson says that there remains within health care a refusal to confront providers’ responsibility for the problems. He suggests initiating emergency corrective-action comparable to Flexner’s crusade against charlatan medical schools.

"If you don't concede you have failed, everything is suspect."
- Vartan Gregorian of the Carnegie Corporation


"Disclosing unanticipated outcome to patients: The art and practice"
by Thomas Gallagher, Lucian Leape and others
Journal of Patient Safety, September 2007
". . . available evidence suggests that open communication of unanticipated outcomes occurs infrequently."

 

Infection tracking raises rate of reporting
The federal Agency for Health care Research and Quality reported that the rate of adverse events—a key measure of patient safety defined as unintended harm during medical care—has risen by about 1% in each of the past six years, in part because of a rise in hospital infections. Other studies show that one in seven hospitalized Medicare patients experience one or more adverse events. One in 15 hospitalized children are harmed by medication errors. And those are just the ones that get recorded.

 

Publicizing errors motivates health care to improve
Judith Hibbard, a professor of health policy at the University of Oregon, says, "We've done some research on this. And making it public makes a big difference." Her research found that hospitals improved safety more when their mistakes were made public than when they were just reported back to the hospital or not reported at all. "The hospitals were primarily motivated to improve because of their public image and reputation," she said. "Just knowing that they're not doing great isn't enough. Unless there's something at stake, they're not motivated to change."

Lisa McGiffert, director of the Safe Patient Project of Consumers Union, is another advocate of public reporting of errors. She said, "Reporting is a form of accountability. And hospitals should be accountable to the public they serve. . . And that should include reliable information about how safe their hospital is, how safe their care is."

Joe Nocera of the New York times calls it the Heisenberg Journalism Principle. In physics the Heisenberg Uncertainty Principle says that the process of observing subatomic particles affects their behavior. Nocera points out that the process of observing people and institutions affects their behavior too.

According to Diane Suchetka in The Cleveland Plain Dealer, May 11, 2010, some medical safety experts say public announcement of errors is the best way to prevent them.

For peer reviewed academic studies affirming this, see:
1) Ehrenkranz NJ. Surgical wound infection occurrence in clean operations. Am J Med 1981;70:909-14.

2) Cruse PJE, Foord R. The epidemiology of wound infection: a 10-year prospective study of 62,939 wounds. Surg Clin North Am 1980;60:27-40

 

A possible solution
From Slate, "The Wrong Stuff,"
By Kathryn Schulz, Monday, June 28, 2010
http://www.slate.com/blogs/blogs/thewrongstuff/archive/2010/06/28/risky-business-james-bagian-nasa-astronaut-turned-patient-safety-expert-on-being-wrong.aspx
According to James Bagian, director of the Veteran Administration's National Center for Patient Safety, people report only when they feel it's in their interest to do so. Since you can't fix problems you don't know about, it is important to get reports that reveal what has gone wrong. So how do you get them to report?
In 1998 they did a survey and found that the chief reason people don't report is embarrassment and humiliation. In response, the VA devised a definition of "blameworthy acts," which must include either assault, rape, or larceny, or being drunk or on illicit drugs, or purposely doing something unsafe. In the ten months after implementing that definition he says reporting went up 3000 percent.
One must be encouraged by anything that appears to increase reporting, but one also must wonder how much was actually accomplished. Their definition suggests that the only things about which people should or would be embarrassed are, for the most part, crimes, as though there is no reason to be embarrassed about indifference or incompetence or ignorance or anger or jealousy or prejudice or declining physical strength and coordination or any number of other things. And 3000% of what? If the rate of reporting at the beginning was low enough, they might still be reporting only a single digit percentage of what needs to be reported. (See the report higher on this page that found that none of the adverse events reported by patients had been submitted by clinicians to the hospital's incident-reporting system in "What Can Hospitalized Patients Tell Us About Adverse Events? Learning from Patient-Reported Incidents" in the Journal of General Internal Medicine, Volume 20, Issue 9, 2005, pages 830-836.) A 3000% increase is not much when starting at zero.
On top of that, what has been left off the table in this effort is the most important thing that could be included: crimes like assault and rape and all the other sins in which humans indulge when they believe they can get away with them.
Mr. Bagian continued saying that the only reason to have reporting is to identify vulnerabilities, not to count the number of incidents. Reports are never good for determining incidence or prevalence, because they're essentially voluntary. Even if you say "You must report," people will report only when they feel it's in their interest to do so.

So even he is saying that the reports on which he bases his 3000% number are not reliable for determining numbers like his 3000% number. Any increase in reporting is encouraging, but it would be nice to get a second opinion on just what happened, and how much of it happened, as a result of whatever management practices were implemented at the VA.

For instance, a Government Accountability Office report and a review by the VA Office of Inspector General pointed to weaknesses in policies and oversight of medical equipment at VA facilities after the above figures were published.

“Despite changes to improve VA’s oversight with selected reprocessing requirements, weaknesses still exist,” the GAO report states, "weaknesses [that] render VA unable to systematically identify and address noncompliance with the requirements. . .” (http://tinyurl.com/FedNews-5-4-2011)

So how reliable is the information he put out stating what large improvements have been made? I suspect not very. Which is the way it is throughout medicine in matters like this. They keep managing to persuade themselves that they have made great strides in spite of none of the numbers changing, numbers like the rate of unnecessary death, injury, misdiagnosis, etc.

In addition to being director of the Veteran Administration's National Center for Patient Safety, James Bagian is, among other things, an engineer, an anesthesiologist, a NASA astronaut, and a mountain rescue instructor.

This is not new

The example of Dr. Benjamin Rush 200 years ago shows that none of this is new. What is new is that for the first time in history there is a practical way to gather from patients the information that people in medicine never have reported and probably never will. For instance, does someone really think a pedophile or other sex abuser is going to file a report him or herself? If you think their colleagues will report them, you haven't been a victim.

"Real power begins where secrecy begins."
- Hannah Arendt

Arendt's "Origins of Totalitarianism"The determination of health care professionals to cover up sins and errors at all costs is born out by the scholarly journal articles cited on this page. Studies done by everyone from AHRQ to HHS to the Annals of Internal Medicine show how little accurate reporting there is in medicine. The rate at which adverse events accurately are reported can be referred to as 2% or 3%. Injured patients have known this for decades. Health care professionals almost universally are in denial about it. They have hidden the problems so well that even they themselves cannot see them.

"The immediate silence from the physicians, nurses and the hospital's chief executive officer was deafening. I felt connected with the staff, having worked for an HMO in the area for a number of years. Now, all I was seeing was a classic pattern of denial and defense."

From: The aftermath of a 'never event' - A child's unexplained death and a system seemingly designed to thwart justice
By: Dale Ann Micalizzi
Modern Healthcare March 3, 2008

In the same breath that health care professionals insist that they and their colleagues report everything, they say that "of course you have to protect yourself from lawsuits" - which is done by not reporting anything.

In the book Justin's Hope (links to another site) Dale Ann Micalizzi said: "I never wanted lawyers involved. I never wanted to question a physician's judgment or a hospital's care. There was no other option available to us. . . "

". . . it isn't worth a lawyer's time to accept such a case unless the evidence is overwhelming and an easy settlement attainable."

Of the patients with legitimate grievances, only one in some thousands can get a lawyer (see Studdert). And even they have to sign gag agreements. So the patient community does not learn where most injuries are incurred. Neither does the medical community. Caregivers do not share their failures with each other except in rare circumstances. An inept clinician easily can define his/her experiences in a way that prevents even his/her own recognition of having a poor success rate. Arendt's "Origins of Totalitarianism"No one disinterested is keeping track.

"The reason why the totalitarian regimes can get so far toward realizing a fictitious, topsy-turvy world is that the outside nontotalitarian world . . . indulges also in wishful thinking and shirks reality. . ."
- Hannah Arendt