Transcript Medication Error Reporting Systems and Disclosing Errors to Patients

Medication Error
Reporting Systems
and
Disclosing Medication Errors
to Patients and Families
Learning Objectives
• Describe the differences between internal
and external event reporting systems
• Discuss the multidisciplinary role of
tracking medication errors and disclosing
those trends to patients
• List the barriers to disclosing medication
events to patients
Medication Error
Reporting Systems
• Error reporting systems promote the goal of providing the
best possible patient care in a safe, compassionate
environment by helping those involved learn about:
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Potential risks
Actual errors
Causes of errors
Prevention of recurrent events
• Both internal and external systems for reporting and
tracking errors are necessary
• Voluntary and mandatory systems each have strengths
and weaknesses
Definitions
• Adverse drug event (ADE)
– Any injury resulting from medical intervention related to a drug
• Preventable ADE
– ADE that results from an error or equipment failure
• Error
– Failure of a planned action to be completed as intended
• Medication error
– Any preventable event that may cause or lead to inappropriate
medication use or to patient harm while the medication is in
the control of the health care professional, patient, or
consumer
• Close call or near miss
– Medication error that was detected and corrected before it
reached the patient
– Medication error that reached the patient and did not cause
harm because of chance
Purpose of Reporting Systems
• Strong error reporting systems are invaluable in highlighting
hazards related to medication use, including ADEs, medication
errors, close calls, and near misses
• 1999 Institute of Medicine (IOM) report, To Err Is Human,
describes two primary purposes of reporting programs:
– Hold providers accountable for performance and patient safety
– Provide information that leads to new knowledge and improved
patient safety
• Some hospitals resist the IOM’s call to accountability for fear
that ADEs may be publicly disclosed
• Purposes of internal error reporting systems:
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Improved management of individual patients
Getting timely medical advice
Providing a record of events
Obtaining immediate legal counsel
Kohn LT, et al., eds. To Err Is Human: Building a Safer Health System. Washington, DC:
National Academies Press; 2000.
Purpose of
Reporting Systems (continued)
• Ideally
– An error is reported internally, investigated, and error reduction
strategies implemented
– Error reduction strategies are then reported to an external
program
• Purposes of external error reporting systems
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Generate widespread alerts
Widely disseminate new ways to prevent errors
Uncover trends and hazards
Recommend best practices for all health care stakeholders
Responsibility for Reporting
• The best person to report an event is the one who was
involved or who found or witnessed the event
• Most medication errors are reported by nurses or pharmacists
• Everyone associated with health care could potentially make
reports (e.g., pharmacists, physicians, nurses, dentists, techs,
assistants, medical equipment vendors)
• Consumers may report suspected medication errors to:
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External voluntary error reporting programs
Appropriate licensing boards
Facility in which error occurred
Person(s) making the error
• The facility should thoroughly investigate any reported
medication error
Reportable Events, Conditions,
and Priorities
• It is essential to use clear, consistent terminology when
reporting events
• The word “event” is used by many organizations because the
word “incident” has the connotation of being a crisis
• Event has a broad connotation
– Clearly define the types of events and conditions to be reported
• Not knowing what to report is a barrier to reporting
• The categories of conditions and events reportable to error
reporting systems are:
– Risk: hazardous conditions that could lead to an error
– Near misses/close calls: errors that were intercepted and
corrected before reaching the patient
– Errors, no harm: errors that reach the patient but do not cause
harm
– Errors, harm: errors that reach the patient and cause harm
– See textbook page 517 for more detailed information
Reportable Events, Conditions,
and Priorities (continued)
• Provide staff members with examples of adverse occurrences
to minimize confusion about what is desired
• Near misses and conditions that could lead to errors or “less
serious” errors all provide information about the underlying
system-based causes of medication errors
– All of the above should be reported
– Allows systems to be proactive in identifying system failures
– Less devastating to report events not causing harm than to have
to report harmful occurrences
• Institutions should encourage personnel to report events and
not to assume that the problem is already known
• More complete reporting enhances the ability to learn about
errors and to implement appropriate safeguards
Reporting Mechanisms
• Staff must understand both formal and informal (alternative)
methods of reporting events
• Informal lines of communication help to enhance trust and
confidence
• Both formal and informal ways of accepting information
should be part of the event reporting mechanism
• Reports may be submitted by e-mail, especially for external
reporting systems
• The organization that maintains the reporting system should
track the effectiveness and usefulness of the various
systems and make adjustments if necessary
• Event reporting forms with electronic formats are provided by
both internal and external reporting programs
When to Report
• Best approach is to immediately report an event
whether or not it may cause serious harm
• Advantages to immediate reporting:
• An ADE that may not seem serious may, in fact, be serious
• The supervisor can ask questions while the event is fresh in the
reporter’s mind
• An immediate oral report to a supervisor may be more
beneficial than a hastily written report
• Send final reports to risk management within 1 week of
the event unless additional time is requested in the
report
• Report to the external voluntary reporting system after all
the information is gathered
– These systems have specific reporting time frames and all
information may not be available
What Information to Report
• JUST THE FACTS—include a factual description of
what happened and the patient outcome
• Include names of products if the event involves a
problem with labeling or packaging
• Include any additional patient monitoring or testing
performed or medications administered as a result of
the event
• Include explanatory information that describes:
– How the event happened
– What normally happens and how risk was managed
before the event
– Why the event happened
– At-risk behaviors
– How to prevent similar events
What Information
to Report (continued)
• Figure 19-1 in the textbook provides an event reporting
form with questions designed to elicit causative factors
for reporting
• Separate the causative and prevention portions from the
factual to better protect event analysis from discovery
during a lawsuit
• Never include personal or professional opinions,
conclusions, criticisms, accusations, admissions, or
patients’ names in the report
JUST THE FACTS
Categorizing Reports
• Categorize reports according to the severity of patient
outcome to help organizations monitor patient harm and
prioritize their medication safety activities
• Figure 19-2 in the textbook shows an index for
categorizing medication errors from the National
Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP)
– The NCC MERP index considers factors such as whether the
patient was harmed, and if so, to what degree
– All event reports are useful for learning and for change even if
there was no harm to the patient
– All reports should be investigated and acted upon if appropriate
Mandatory Reporting Programs
• The IOM recommended both mandatory and voluntary
reporting programs
• The Institute for Safe Medication Practices (ISMP), the
American Hospital Association, and the American Medical
Association objected, saying mandatory reporting would stifle
reporting because of heightened fear of damaged reputations
and legal liability
• In the United States today, both mandatory and voluntary
reporting systems are in operation
– Fundamentally, all reporting is voluntary
– Threat of punishment will decrease likelihood of reporting
• The lack of success may be less about the mandatory nature
and more about the design of the reporting systems, the
punitive culture, and the ineffective use of data submitted
Limited Success of
Mandatory Programs
• Usually run by the state departments of health and the
licensing boards that require reporting
– There is potential to generate useful data
– Requirements for reporting are inconsistent
– Amount of useful information and the number of reports varies
• Organizations may underreport to avoid penalties, punitive
actions, and legal and public scrutiny
– Some practitioners are reluctant to report errors to external
mandatory programs, but will report errors internally
– Health systems cannot make it safe for staff to disclose errors to
mandatory programs that hand down punishments
– The designated reporter is charged with minimizing the
organization’s exposure to liability and public distrust
• Outcome-based event analysis is especially prone to
hindsight bias
Mandatory State Programs
• Less than half of the U.S. states require mandatory
reporting
– States are not consistent in the types of events reported, the
number of events, or the requirements for reporting
• Most investigate serious events
– The only consistent reportable event is unanticipated death
– Health professionals and health systems rarely receive feedback
– Information about professionals sanctioned for errors are
published by licensing boards
– Health departments typically make some findings public but
insulate detailed information from legal discovery
– Need for research about whether safety changes are made by
practitioners that would not otherwise have been made as a
result of mandatory state reporting
Patient Safety Centers
• Six states (Florida, Maryland, Pennsylvania, Oregon,
Massachusetts, and New York) have created patient safety
centers
– The functions vary from state to state but they arose as a result of
health issues such as affordability and malpractice reform
– Seek to educate providers about best safety practices for patients
– Have governing boards and consumers in an advisory capacity
– Most of the centers operate under little or no state regulatory
control
– Each center submits mandatory periodic progress reports to a
governing body
– Most disclose findings to the public, some utilizing the Web
– All but Oregon have mandatory reporting systems for serious
adverse events
• Table 19-1 in the textbook compares features of these patient
safety centers
Pennsylvania’s Unique Program
• The mandatory Pennsylvania Patient Safety Reporting
System (PA-PSRS) requires the reporting of close calls,
near misses, and serious adverse events by all licensed
hospitals, birthing centers, and ambulatory surgical
facilities
• The Patient Safety Authority (PSA; an independent,
nonregulatory state agency) is authorized by the PAPSRS
– PSA analyzes reports for learning purposes, keeping the
information confidential and not available to the public
– Whistleblowers are protected and may report anonymously
– Individual health care facilities can use PA-PSRS to monitor the
progress to improve safety at their facilities
Pennsylvania’s
Unique Program (continued)
• Pennsylvania uses a program subcontracted to ISMP to
analyze medication-related errors and adverse drug reactions
reported to the system; suggests ways to avoid future errors
• New information about the sources and causes of medication
errors is now available to ISMP and other safety experts
• Patient Safety Advisory, published quarterly, is based on
analysis of errors and near misses
• The 2004 data from Pennsylvania are consistent with national
data, which show the following:
– Approximately one-fourth of reported medication errors involved
one or more high-alert medications
– Two out of three harmful events involved one or more high-alert
medications
Voluntary Reporting Programs
• Voluntary systems are generally more successful than
mandatory systems because:
– Reports come from frontline practitioners who can describe the
conditions that led to the event and provide detailed information
– Conclusions can be drawn without waiting for numerous reports
– Information is immediately useful to help create a plan for
improvement
– There is trust between the reporters and the recipients
– Systems are perceived as credible because they are independent
of regulatory and accrediting bodies
– A nonpunitive approach recognizes that human error is inevitable
– Analysis is system or process oriented rather than outcome
oriented
– Error reduction efforts are not targeted at the individual but toward
strengthening the system to lessen the possibility of error
• Table 19-2 in the textbook lists elements identified by ISMP that
encourage error reporting
USP-ISMP Medication Errors
Reporting Program
• United States Pharmacopeia (USP) operates the medication
errors reporting program (MERP) in cooperation with ISMP,
which receives all MERP reports, analyzes reports and
aggregate data, and disseminates the findings
– USP or MERP automatically passes error reports to FDA’s
MedWatch
• FDA focuses more on packaging, labeling, and nomenclature issues
than with practice issues or health care system failures
– Product-related reports are sent to manufacturers
• Reporting process of medication errors to USP-ISMP is
described on page 529 of the textbook, including the phone,
fax, e-mail, address, and Web site
– Reporters are often willing to answer questions and provide
supplemental materials such as photos and redacted orders
– Reporters hope that their information will lead to changes for
preventing future errors and patient harm
USP-ISMP Medication Errors
Reporting Program (continued)
• MERP can:
– Objectively determine causes of errors and find solutions
because it is independent of other agencies
– Analyze reports to provide information about the types,
causes, and prevention of errors
– Perform individual investigation and follow-up because it
has a small number of reports
• MERP cannot:
– Discipline, regulate, or mandate implementation of the
recommendations that come from the analysis
– Determine the prevalence of medication errors
– Provide the names and locations of reporters
Analysis of Reports to MERP
• The goal at MERP is to learn from reported events or
hazards, preventing them in the future, and extrapolating the
system-based solutions to all health care settings
• 2004 MERP data analyzing errors showed:
– 57% of the submitted reports documented errors that reached
the patient (see Table 19-3 for the categories of reported errors)
– 13% of the errors caused temporary harm
– 2% of the errors resulted in permanent harm
– 1% of the errors resulted in death
– 43% of the reports were from hazards that could lead to errors
• Most of the errors reported to MERP in 2004 involved either
the wrong drug, wrong dose, or prescribing errors
– Table 19-4 in the textbook lists types of errors reported to MERP
MERP Documented Errors
Reports Submitted to USP-ISMP Medication Errors
Reporting Program in 2004
Analysis of Reports
to MERP (continued)
• Table 19-6 in the textbook enumerates the leading
products involved in harmful errors in 2004, including
several pharmaceutical products
• Drugs not currently considered high-alert medications
were among the leading products on the 2004 list,
including:
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Lipitor and Zocor
Phenergan
Seroquel and Serzone
Clonidine
Diflucan
Lithium
Metoprolol
Impact of MERP
• Early warning system
– ISMP immediately sends out electronic alerts, including subscription
to free e-mail alerts, when MERP indicates serious hazards
• Learning
– Information about error prevention is shared through educational
programs, newsletters, teleconferences, and the Web
• Change
– Surveys and reports show information provided by ISMP is stimulating
changes by individuals and organizations
• Standards
– Information from MERP is often shared with agencies (e.g., The Joint
Commission [TJC], FDA, and state health departments) and USP’s
standards and drug information database also has been impacted
• Public policy
– ISMP and USP use information from MERP to promote changes in
public policy to enhance safety
• Appendix A (pages 546–9 in the textbook) lists examples of the
nationwide impact of MERP
FDA MedWatch
• A voluntary reporting program that receives reports from
health care professionals and consumers involving:
– ADEs, product use errors, biologics, medical devices, nutritional
products, and cosmetics
• Does not accept reports involving vaccines
• New products are monitored through the FDA and the
pharmaceutical industry
• Reporter does not need proof, only suspicion, to submit an
event report
• Contact information for MedWatch:
– Fax: 1-800-FDA-0178
– Phone: 1-800-FDA-1088
– Internet: www.fda.gov/medwatch/report/hcp.htm
FDA MedWatch (continued)
• FDA reviews product-related errors, but not practice-related
errors, reported to MERP
• Names of reporters divulged only with permission from reporter
• ISMP can review reports submitted to MedWatch, but can
interview the reporter only through a third party within FDA
• Narrative reports submitted are not available electronically
• The Adverse Event Reporting System combines required reports
from manufacturers and voluntary reports from MedWatch thus
creating an even broader safety program
– 5% of the reported events to the FDA in 2004 were voluntary, the
rest came from manufacturers
– FDA’s Division of Medication Errors and Technical Support
(DMETS) analyzes reports and provides feedback
– DMETS investigates causes and contributing factors and offers
recommendations for label or packaging revisions
The Joint Commission
Sentinel Event Reporting Program
• TJC asked accredited health care organizations in 1996
to identify and voluntarily report all sentinel events
within the facility
– A “sentinel event” is an unexpected occurrence involving death
or serious physical or psychological injury, or the risk thereof
– The phrase “or the risk thereof” refers to any process variation
whose recurrence would carry a significant chance of a serious
adverse outcome
• The sentinel event policy requires organizations to:
– Investigate root causes within 45 days of becoming
aware of a sentinel event
– Implement strategies to prevent recurrence
– Monitor the effectiveness of implemented strategies
The Joint Commission Sentinel
Event Reporting Program (continued)
• The reporting program is not entirely voluntary
– If TJC learns about an event that the health system has failed to
report, the health system must conduct a root cause analysis
within the specified time frame or risk being placed on
“accreditation watch” status with public disclosures
– No matter how the event comes to the attention of TJC, the
response, time frame, and review procedure are the same
• TJC provides expertise in the analysis of an event and
validates that system-based changes have been made
• The amount of knowledge gained from an event is
lessened and the disclosure of errors is inhibited when the
reporting program has the authority to mandate actions
The Joint Commission Sentinel
Event Reporting Program (continued)
• 1995–2005: the sentinel events reported to TJC included
patient suicides, wrong-site surgery, operative or
postoperative complications, and medication errors
• 1995–2004: most common root causes of medicationrelated sentinel events were communication failures,
inadequate orientation or training of staff, inaccurate
patient assessment, staffing issues, and unavailable
information
– Figure 19-3 in the textbook shows the breakdown of root causes
of medication errors for 1995–2005
– Figure 19-4 graphs an example of one such sentinel event
USP MEDMARX
• Internet-based system launched in 1998
– Subscribers upload data from internal reports, track the data,
and learn about errors reported by other facilities
– Reporting is anonymous and standardized
– Allows for data to be aggregated for comparison with
demographically similar facilities
• By 2005, about 800 facilities paid a fee and subscribed
• USP’s Center for the Advancement of Patient Safety
(CAPS) analyzes the data for the purpose of creating
educational programs and products that focus on error
analysis and prevention
• Appendix B (pages 549–50 in the textbook) includes
topics featured in the MEDMARX annual reports
Veterans Affairs Patient Safety
Reporting System
• Veterans Affairs (VA) staff can voluntarily report events or
concerns on a standardized form by mail to the VA’s
external Patient Safety Reporting System (PSRS; an
independent complementary system, established in 2002)
– Does not replace the VA’s internal reporting system; PSRS is a
reporting system some staff may be more comfortable using
– PSRS was jointly developed with NASA, making use of NASA’s
30 years of experience with the Aviation Safety Reporting System
• PSRS guiding principles
– Voluntary participation
– Confidentiality protection
– Nonpunitive reporting
Veterans Affairs Patient Safety
Reporting System (continued)
• Reports of events involving criminal actions, purposefully
unsafe acts, and alleged or suspected patient abuse are not
accepted by PSRS
– These actions are not protected information
• Reporters are encouraged to include identifying information so
they may be contacted if clarification is needed
– All identifying elements are removed once the report is declared
complete, including all names and locations
• Only 400 reports were received in the first 2½ years, while the
internal VA system received 14,000 reports
• VA facilities are immediately alerted if an alarming safety trend
is identified
– The source of the problem is not identified
Disclosure of Error Reports:
Public Disclosure
• Thoughts on public disclosure vary, including:
– Making it mandatory for health care practitioners to divulge
information
– Public disclosure is necessary to encourage improvements
– Disclosure of adverse events will cause error reporting to go
underground, weakening the effort to ensure patient safety
• The public has rights regarding disclosure of patient safety
issues such as:
– The right to expect steps are taken by health care organizations to
deal with safety hazards
– The right to be informed about unsafe conditions
– The right to expect companies that make any health care products
to do their part to ensure error-proof health care
– The right to expect companies and providers to be held
accountable for implementing safety strategies
Disclosure of Error Reports:
Public Disclosure (continued)
• The public wants evidence that health care providers value
patient safety above all
– Safety recommendations should be evaluated by regulatory,
federal, and accrediting agencies as well as by health care
purchasing groups
• The reporting system should not have the power to mandate
the implementation of recommendations, but they should be
adopted if the efficacy and cost benefit are favorable
– Public disclosure should be considered if the agencies and groups
do not adopt the recommendations
• To help make informed decisions, consumers can review:
– An organization’s compliance with safety standards
– An annual report summarizing events and actions
Disclosure of Error Reports:
Legal Disclosure
• Most states have some legal protection for information
submitted to internal reporting programs operated for
quality improvement purposes
– The offer of confidentiality and evidentiary protection for the
information submitted is one of the best incentives for reporting
– Lacking federal protection of reporting information is a reason
many external reporting systems and safety experts do not
receive information
– Protection under state law may be waived if the information is
shared externally
– ISMP and many other safety experts subscribe to the belief that
information from external reporting systems should be privileged
for purposes of governmental judicial proceedings
Disclosure of Error Reports:
Legal Disclosure (continued)
• Congress enacted the Patient Safety and Quality
Improvement Act of 2005 to encourage more participation
in external error reporting systems
– Calls for independent patient safety organizations (PSOs) that
receive, analyze, and disseminate confidential data
– The PSOs are to be certified
– The information PSOs receive cannot be used in civil or
administrative legal proceedings, thus lessening the threat of
litigation while protecting patients’ rights to legal remedies
Practitioners’ Perspectives
on Reporting
• A 2002 ISMP survey found that the majority of staff-level
clinicians surveyed feel more effort is needed to promote
voluntary reporting, both internally and externally
– Those responding more often reported safety issues to internal
rather than external programs
– Table 19-7 in the textbook shows frequency of reporting
medication errors or safety issues
– Medication errors that caused no harm, whether or not they
reached the patient, were most often reported internally
– Hazards that could cause errors were not often reported internally,
but were the issues most often reported to MERP
– Errors associated with harm were more often reported internally
• The survey found that at least half of the respondents had
reported one harmful error internally, but only one in ten had
reported a harmful error to MERP or MedWatch
Practitioners’ Perspectives
on Reporting (continued)
• Adverse drug reactions were reported frequently to internal
programs and less frequently to MedWatch
– MedWatch database may be lacking in critically important
postmarketing surveillance data
• Table 19-8 in the textbook lists motivations for reporting
medication errors and safety issues
• Survey indicated that key motivations for reporting to both
internal and external programs were to enhance patient
safety and avoid needless tragedies
• Those surveyed felt more rewarded reporting to MERP
than to MedWatch or internal programs, suggesting that
more needs to be done to reward voluntary reporting
Practitioners’ Perspectives
on Reporting (continued)
• Table 19-9 in the textbook indicates more promotion of
internal over external programs
– The least promoted external program was MedWatch
• Results show that stakeholders in patient safety must
take more time to encourage frontline practitioners to
report issues, both internally and externally
• Potential reasons for lack of voluntary reporting
– Legal impediments
– Limited knowledge of voluntary external reporting programs
• 2006 IOM report recommendations
– More aggressive error reporting by all stakeholders
– Use of a national taxonomy for data storage and analysis
– Use of aggregated information to shape national health policy
Disclosing Medication Errors
to Patients and Families
Disclosing Medication Errors
to Patients and Families
• The public is increasingly aware of the frequency and
consequences of medical errors
• There is general agreement that disclosure of outcomes
and errors to the patients is the ethical thing to do
– Disclosure is an emotional experience for all involved
– There may be a hesitancy on the part of health care organizations
and practitioners to move toward a process for full disclosure to
patients and families
What Constitutes Successful
Disclosure?
• TJC standards state that a successful disclosure ensures both
patients and families are informed about the outcomes of
medical care, especially the unanticipated outcomes
• Elements of successful disclosure of unanticipated events may
include:
– Absence of litigation
– Understanding by the patient and family that mistakes are
unavoidable
– Calming of the patient’s and family’s anger after an adverse
outcome
– Absence of media coverage
– Ensuring the organization and practitioners are positively
portrayed if there is media coverage
• The true goal is to learn from all adverse events and to use
them as opportunities for improvement
Patients’ Perspective
• The National Patient Safety Foundation (NPSF) recommends:
– Prompt explanation of how an injury occurred and the effects of
the injury
– The explanation should be truthful and compassionate
– The explanation should include remedies available
• Lack of trust in the physician makes disclosure more difficult
• Patients and families know errors occur and they want the
following to happen:
– Systems should be developed for avoiding medical errors
– Give a detailed explanation and a sincere apology if an error
happens
• Practitioners often distance themselves from patients and
families
Patients’ Perspective (continued)
• 2004 survey of consumers regarding medical errors found:
– 92%: reporting should be required
– 88%: physicians should be required to tell them if a preventable
error resulting in serious harm happened in their own care
– 63%: hospital reports of serious medical errors should be made
public
– 34%: had experienced medical errors
• 28% of these respondents had been told about the error
– 54%: believe the physician would be very or somewhat likely to
tell them about a preventable error that resulted in serious harm
– 79%: giving physicians more time to spend with patients could
reduce errors
– 72%: require hospitals to develop systems for avoiding errors
– 72%: better trained health professionals could reduce errors
– 21%: malpractice lawsuits would help reduce medical errors
Health Care Providers’ Perspective
• Physician responses varied, from always disclose complications
to disclose those that cause harm, unless the harm is trivial or
the patient is unable to understand the error
• Near misses should not be disclosed, preferring to handle them
as the physician’s problem
Physician definition of error:
Deviation from the accepted standard
of care
Patient definition of error:
All unpreventable adverse events, as
well as poor service quality and low
interpersonal skills on the part of the
practitioner
• Risk managers surveyed:
– More than half always disclose death or serious injury due to error
– Less likely to disclose preventable harm than unpreventable harm
– Those who felt disclosure increased the risk of litigation were more
likely to disclose unpreventable harm over preventable harm
Experience With a
Full Disclosure Policy
• The Lexington, Kentucky, VA Medical Center had lost $1.5 million
in malpractice judgments
– In 1987, this facility adopted a full disclosure policy with equitable
compensation for actual losses due to errors
– Center notifies patients and families as quickly as possible
– Settlements are numerous, including some that might not have been
filed without the honest disclosure
– Hospital even assists in the filing of claims
– Attorneys are provided with clinical information
– Attorneys may negotiate a settlement on the basis of monetary
losses rather than seeking a more punitive judgment
• All of these actions lessen patients’ anger and desire for
retribution
• Result was not an overwhelming number of lawsuits
– Payments for claims were moderate with the economic outcomes
remaining positive more than 10 years later
Experience With a
Full Disclosure Policy (continued)
• Full disclosure to patients and families is now mandatory at all
VA facilities, including:
– A face-to-face meeting with the VA chief of staff, the quality
manager, the quality management nurse, and the facility director
– All details of the event, including names, are given
– The facility emphasizes their regret and the actions being taken
to prevent similar events
• The VA system is unique—it is a closed system and can offer
restitution such as:
– Universal health coverage
– Free corrective treatment
– Monthly disability payments to patients
• VA practitioners pay no malpractice premiums and are
protected from liability
Legal Concerns
• Legal liability is the reason most often given as the
reason for avoidance of full disclosure of error
• Health care organizations fear the information could be
used to pursue litigation
– Research and anecdotal evidence show that this fear may be
exaggerated
• Most lawsuits are motivated by:
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Poor communication between patients and their caregivers
Breakdown in trust between providers and patients
Suspicion of a cover-up
Desire for revenge when an event is not immediately disclosed
but later discovered
– A feeling of betrayal
Legal Concerns (continued)
• Practitioners are reluctant to talk openly about the event, and
even more reluctant to apologize, fearing an admission could
lead to litigation
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An apology diffuses the situation
An apology is not necessarily an admission
An apology is not costly and is rewarding
Some states protect “benevolent gestures” from use as evidence of
culpability in legal cases
• Outright admission of error is admissible in court
– The disclosure team should discuss the risks and benefits of saying,
“I’m sorry this happened to you,” versus “I’m sorry we did this to you.”
– Disclosure does not protect practitioners and facilities, but it may
diffuse the emotional feelings that would trigger litigation
• Offering a fair settlement may avoid a costly trial, or at least
influence a jury to consider reducing the award since there was
a gesture of compensation for injury
Personal Barriers
• Clinician barriers to successful disclosure of errors:
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A sense of failure
Damage to reputation
Fear or retribution from patients or colleagues
Fear of conducting the conversation poorly
Fear of having to handle emotions, the recipient’s and their own
Belief that disclosure is unnecessary
Unfounded belief that they had no direct involvement in the event
Unfounded belief that the event would have happened anyway
• Practitioners should receive emotional support during the
whole process
What to Disclose?
• Barron and Kuczewski suggest criteria for determining
disclosability:
– The outcome would not be included in a reasonable informed consent
process, would not be expected during usual treatment, or both
– It is not possible to exclude error, human or system, from the cause of
the outcome
– Near misses do not fit the criteria for disclosure
• Two arguments regarding near misses:
– Disclose if patient is aware of near miss
– Do not disclose because it may create anxiety and is not needed for
patient to make treatment choices
• A benign error that reached the patient, but caused no harm:
– May disclose if additional monitoring, observation, or treatment is
needed to detect, reduce, or eliminate the risk of harm
– May choose not to disclose if no treatment or precautionary measures
are necessary and if harm from the error is not a possibility
Barron WM, et al. Jt Comm J Qual Saf. 2003;29:551–5.
Who Should Disclose the Error?
• Those involved in disclosure of error to patients can vary
according to the circumstances
– The attending physician may or may not be the best communicator
but should be present
– Risk managers should also be involved even though physicians
think they are not always in favor of disclosing errors to patients
– Physicians, other practitioners, and risk managers should
collaborate to create a disclosure policy and method of
communication that will work best for their facility
Models of Disclosure
• The American Society for Healthcare Risk Management offers
these models based on facility size
– Small: one designated person, trained to have effective disclosure
communication skills
– Small to medium-sized with sufficient staff: create a team trained
in effective disclosure skills and communication of the policies
– Medium to large organizations, especially to establish physician
buy-in: a train-the-trainer model with a large group of practitioners
and others who undergo disclosure training and in turn become
trainers and role models for staff
– Organizations with a mature culture of patient safety and
widespread clinician buy-in: clinician at the site, who has a
relationship with the patient, discloses the error, with guidance from
an in-house coach who meets with the clinician just before the
meeting with the patient
• Organization must follow all state, federal, and TJC standards
Available Tools
• The Minnesota Hospital and Healthcare Partnerships offers a
communication policy framework for discussions
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Expression of regret and apology
Time, place, and circumstances of the accident
The proximate cause, if known
Actions taken to treat any consequences of the accident
Who will oversee the ongoing care of the patient
Plans for investigation or review of the incident
Other parties informed of the event
Actions taken to identify systems-related causes and preventive
efforts
Who will oversee ongoing communication with the patient
Contact information of agencies with which the patient or
representative can communicate about the event
How the patient can obtain support and counseling from the facility
and from outside the facility
Process for discussing compensation for harm
Available Tools (continued)
• The Institute for Healthcare Improvement Web site
has a sample serious event disclosure policy
• The ISMP Medication Safety Alert! described on page
558 of the textbook provides an outline for preparing
for a damaging medication error
Staff Education and Support
• Staff education should include:
– The use of appropriate terms, defined in positive language
– Active learning about the barriers to medical error
communication
• Debriefing sessions and private support counseling for
staff members involved in an error
• A culture of safety must be created by leaders who
support error reporting
• The pledge to disclose has proven to be challenging
because individual practitioners are still cautious about
disclosing errors to colleagues or superiors, regardless
of anonymity
References
Barron WM, Kuczewski MG. Unanticipated harm to patients:
deciding when to disclose outcomes. Jt Comm J Qual Saf.
2003;29:551–5.
Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human:
Building a Safer Health System. Washington, DC: National
Academies Press; 2000.