BY: MARK KADZIELSKI, JD, and CATHERINE MARTIN, RN, BSN, MPA
Mr. Kadzielski is head of West Coast Health Law Practice, Fulbright &
Jaworski, LLP, Los Angeles; Ms. Martin is director of Performance Improvement,
VHA West Coast, Pleasanton, CA.
A year ago we wrote about the complex process involved in
identifying, categorizing, and assessing medical error in health
care in the United States ("Assessing
Medical Error in Health Care," Health Progress, November-December
2001, pp. 14-17). That article discussed the 1999 Institute
of Medicine (IOM) report on medical error, "To Err Is Human,"
and the erosion of public trust in U.S. health care.
The IOM report has inspired many proposed solutions to the
medical error problem. Some of these solutions present difficult
challenges for health care providers whose resources have already
been stretched by other problems, including nursing shortages
and bioterrorism fears. Even so, Catholic health care providers,
with their commitment to moral and ethical values, should be
in the forefront in the development of a new culture of patient
safety.
Toward a Culture of Safety
How can we — using our knowledge of both medical error and the obstacles to solving
it — prevent medical error in an efficient and effective way? Success, we believe,
will come from combining efforts and focusing on creating a culture of safety.
Of course, making a cultural change in an organization is very difficult
and takes time. However, it can be done — with the genuine commitment of the organization's
leaders.
Creating a culture of safety requires that safety and reduction of medical
error truly become a top priority of the entire organization — a priority demonstrated
in action, not just in words. Catholic organizations can capitalize on the fact
that they see health care as an essential good and a service to people in need.
Providing a safe environment for all patients is integral to health care that
serves the common good. The leaders of Catholic organizations will, by focusing
on these important values in their communication and interaction with their
staffs, facilitate a more rapid adoption of, and commitment to, a culture of
safety.
One huge barrier to developing a safety-oriented culture is the tendency of
health care professionals, administrators, and physicians to blame and punish
those who commit errors. A blaming, punitive atmosphere impedes the reporting
of medical errors and "near misses" and encourages staff to cover up latent
errors that might otherwise have been uncovered.
Developing a blame-free environment usually requires leaders to change their
perspective and, above all, apply the new concept consistently. A single firing
or disciplining of a health care worker found to be at the "sharp end" of an
error can undermine many months of policy development and communications with
staff. Actions speak louder than words. Punitive action taken as the result
of a frontline staff member's reporting of an error will undermine the staff's
faith in the leaders' ability to follow their own new policies. Some leaders
fear that a blame-free system will exempt clinicians from accountability. But
this will not happen if leaders refine accountability into the following premise
and then share it with the staff: Everyone has a duty to prevent error whenever
possible and a duty to report all errors and near misses. Everyone has a duty
to remedy resultant injuries and a duty to disclose such injuries to the injured
parties.
The Veterans Administration (VA) provides a good example of
the false starts that can occur when an organization moves toward
a nonpunitive environment. In 1997, almost a year after the
VA had launched its Patient Safety Improvement Initiative — which
was designed to facilitate learning, not accountability — the
agency formed a new, external panel of Patient Safety System
Design to recommend alternative methods of enhancing reporting
as a means of improving patient safety.1 This was
necessary because although the Patient Safety Improvement Initiative
had provided more information on what was happening in the system,
it still fell far short of its goal. Departing from the typical
"name and blame" approach in medicine is much easier to state
in policy than to implement and cause to be embraced by all
hospital staff.2
When Catholic health institutions incorporate the faith-based value of respect
for the dignity of all persons, including staff members, into leadership strategies
and interactions with all staff, a blame-free environment becomes both more
evident and more credible as the foundation of a true culture of safety.
While hospitals are making efforts to increase the voluntary
reporting of errors and near misses and promoting an educational
analysis for system improvements, other organizations are, with
federal support, implementing mandatory reporting systems. An
example is New York State's Patient Occurrence and Tracking
System (NYPORTS). Implemented statewide in 1998, this Web-based
mandatory system makes it easier for hospitals to report adverse
incidents, as required by state law. In December 2001, New York
Governor George E. Pataki announced that NYPORTS had been awarded
a $5.4 million federal grant. With this money, the state plans
to improve the completeness of reporting so that the data, once
analyzed, can be used to identify risk reduction strategies
and reduce medical errors. Toward that end, New York will sponsor
three demonstration projects that will help hospital systems
study specific types of preventable errors.3
Actual Experience with the New JCAHO Safety Standards
On June 28, 2001, the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) announced that new standards
regarding patient safety and the reduction of medical errors
would be implemented July 1 of that year.4 JCAHO
added these standards to its "Leadership," "Improving Organizational
Performance," and "Management of Information" areas. It also
emphasized patient safety more strongly in its "Patient Rights,"
"Education of Patients and Families," "Continuity of Care,"
and "Management of Human Resources" areas. The new standards,
responsibility for which falls on an organization's leaders,
encourages the development of a culture of safety. In all, 31
new and revised standards have been added to seven functional
chapters. The standards state that hospital leaders are to create
an environment that:
- Encourages error identification and remedial steps to reduce the likelihood
of future, recurring errors
- Minimizes individual blame or retribution to those involved in or who have
reported an error
- Establishes an actual or virtual organization-wide patient safety program
that uses both internal and external knowledge and experience to prevent the
occurrence of errors
In early 2002, JCAHO encouraged patients, by promoting a series of questions
for them to ask health care providers, to take an active role in the prevention
of medical error. The program is entitled "Speak Up." A brochure for it urges
patients to do several things, including:
- Educate themselves on diagnoses, medical tests, and treatment plans
- Speak up if they have questions or concerns
- Ask a trusted family member or friend to be their advocate
- Participate in all decisions about their treatment5
Again, this promotion of a patient-provider partnership to reduce medical
errors will not seem threatening to Catholic health care institutions because
they suffuse all aspects of their operations with faith-based values. This partnership
can and should be used to reinforce the values of respect for all persons and
the belief that health care is a service and an essential good.
Although JCAHO in early 2002 declared a moratorium on scoring hospitals negatively
on patient safety standards in situations where interviewees were unaware of
Sentinel Event Alerts — its newsletter of patient safety advisories — the
commission has directed accreditation surveyors to ask questions about incorrect
site surgery. Our own experience this year has been that the physician surveyor
is asking the following questions:
- Has your hospital had a sentinel event or a near miss with an incorrect
site surgery?
- If yes, then please show your analysis of the root cause of the event or
near miss.
- If no, then please show a proactive analysis of this very high-risk and
problem-prone process.
Through these questions, JCAHO underscores the fact that, despite its issuance
of two Sentinel Event Alerts on incorrect site surgery, the number of
reports of this error has increased. (This occurred during the period
when hospitals were working to establish a blame-free environment, which resulted
in more reports than before of actual events and near misses.) The episode also
demonstrates JCAHO's continued sensitivity to patient safety issues, especially
to the more obvious ones that tend to make newspaper headlines.
JCAHO has further codified its focus on patient safety with
the announcement of six new patient safety goals that will go
into effect January 1, 2003. These goals are disseminated in
the commission's Sentinel Event Alerts; each goal includes
one or two evidenced-based or expert recommendations.6
In the future, JCAHO has said it may continue some goals and
replace others but will issue no more than six goals in each
year.
The commission expects all hospitals to either incorporate these goals (or
an acceptable alternative) or offer surveyors a credible explanation as to why
a goal does not apply. Failure to adopt the goals will result in "type I" recommendations.*
* To maintain accreditation, health care organizations must
resolve type I recommendations within a specific amount of
time.
Disclosure of Information to Patients and Others
One of the most controversial new standards challenges the
way hospitals currently address errors resulting in patient
injury. The new requirement under "Patient Rights (RI.1.2.2)"
says: "Patients and, when appropriate, their families are informed
about the outcomes of care, including unanticipated outcomes."
The "intent" of this standard states, "The responsible licensed
independent practitioner or his or her designee clearly explains
the outcomes of any treatments or procedures to the patient
and, when appropriate, the family, whenever those outcomes differ
significantly from the anticipated outcomes." 7
In the past, health care organizations that feared liability and resultant
legal actions have sometimes chosen not to inform the patient or family members
of medical errors. The new standard forces organizational leaders to begin working
toward a culture of safety and full disclosure of medical error to those affected
by it.
ýhe difficulties with the disclosure process have been emphasized
by both lawyers and health care professionals. As we noted in
our previous article, Americans live in a culture of blame and
punishment, where victims of medical errors expect significant
financial compensation after findings of ultimate fault are
made. This naturally tends to make providers reluctant to disclose
information relating to medical errors. Yet an important distinction
can and should be made between disclosure of errors to patients
and families — which has been shown to have a positive effect
on litigation avoidance — and disclosure of errors to governmental
agencies, or to the public at large — where it may well be used
in the blame/punishment cycle against those providers or others.
Care must be taken to ensure that the patient comes first in
this process and that disclosures made to patients — and made
for his or her benefit — are the top priority.
Although many states have proposed medical error legislation in the past year,
and a significant number have adopted measures intended to prevent medical errors,
only a few have directly addressed the central issue of mandatory disclosure
of errors to governmental agencies — primarily because of the perceived "chilling
effect" such reports might have. The most creative approach has been that taken
by Minnesota, which, in August 2001, established a confidential website where
health facilities could report errors on an anonymous basis and then access
the aggregate data in order to assist each other improve performance and quality.
Health care providers may wish to follow the Minnesota program to determine
whether such anonymous reporting helps improve quality and patient safety.*
* The innovative Minnesota law, S.F. 560, is part of reforms enacted in
2001 to create a Web-based, anonymous error-reporting system. Although other
states have attempted to enact reporting laws to deal with errors, much of
the debate involved has centered on whether the reporting should be mandatory
or voluntary. Some states, such as Colorado, with its Colorado Revised Statutes
25-1-25 (2000), make reports public. Others — for example, Connecticut, in 2000
AB 6941 — make such reporting subject to regulations that have yet to be drafted.
Still others — such as New York's CLS Public Health, section 2998 — establish
"patient safety" centers with directions for the development of a "voluntary
and collaborative" reporting system. Other states are likely to produce measures
such as these in 2003.
In any event, a provider should take care in cases where disclosure
to government agencies is involved, whether the disclosure is
voluntary or mandatory. The provider should consult legal counsel
with expertise in such matters because the disclosure could
provoke a legal chain reaction that lasts for years and exposes
the well-meaning caregiver to pain and suffering from a regulatory,
if not criminal, standpoint.
Leadership Analyses of High-Risk Process
Another new standard that significantly affects hospitals is
in JCAHO's "Leadership" chapter. Standard LD.5.2 states that
leaders must ensure that an ongoing, proactive program for identifying
risks to patient safety and reducing medical/health care errors
is defined and implemented. The key to this new standard is
the requirement for prospective ongoing analysis of a
high-risk process. This is not a root cause analysis of an event
or near miss, but rather an analysis designed to find the potential
failure points before there is an event reported. Since July
1, 2001, JCAHO surveyors have taken discussion and problem-solving
time from the survey agendas to share steps of the JCAHO recommended
method of analysis for this new standard. This technique is
borrowed from the engineering world, where it is known as "Failure
Mode, Effect, and Criticality Analysis" (FMECA). In JCAHO's
accreditation manual, the intent statement for this standard
outlines the need for selecting at least one high-risk process
for proactive risk assessment, identifying failure modes, and,
for each failure mode, identifying its "criticality" — the likelihood
that it will affect a patient.
FMECA is a systematic way of prospectively examining a design for possible
ways in which failure can occur. It assumes that no matter how knowledgeable
or careful people are, failures can happen because of weaknesses in the process.
This method attempts to identify these weak points and their criticality before
the process fails. Performing FMECA involves three steps:
- Listing the failure modes for the proposed or actual situation or design
- Describing the effect of each failure mode on the other components or systems
- For each failure mode, rating the likelihood of occurrence, accessibility,
and detectability, and determining the risk priority
Surgical site verification is an example of a high-risk process that — because
it may have severe repercussions for the patient, hospital, and physician — can
be prospectively examined to meet this standard. Performing surgery on the wrong
limb, organ, or side of the body can obviously have extreme consequences. Although
many people consider such surgical error highly unlikely, its incidence has
in fact been increasing despite sentinel event warnings issued by JCAHO.
Although many health care leaders are uncomfortable with the increased public
scrutiny their organizations have received because of medical error, this scrutiny
will be positive if it results in actions to reduce the frequency and severity
of such error. Creating a culture of safety will, because it makes the frontline
staff feel safe when reporting them, show leaders the frequency and extent of
errors and near misses.
Catholic health care professionals, physicians, and administrators remain
in today's complex patient-care environment because their beliefs and principles
motivate them to provide optimal care for all patients. The challenge for such
leaders will be to recapture the public's trust and confidence and demonstrate
that Catholic health care organizations are committed to providing high-quality
care in a culture of safety with an absolute minimum of medical errors.
NOTES
- J. P. Bagian, et al., "Developing and Deploying a Patient
Safety Program in a Large Health Care Delivery System," Journal
on Quality Improvement, vol. 27, no. 10, 2001, p. 524.
- "ISMP survey on perceptions of a non-punitive culture produces
some surprising results," ISMP Medication Safety Alert,
September 19, 2001, which can be found at www.ismp.org. The
Institute for Safe Medication Practices (ISMP) has developed
a tool that helps hospitals assess staff attitudes as they
struggle to come to terms with individual accountability in
a nonpunitive culture. (The survey questions are available
in the June 27, 2001, ISMP Medication Safety Alert.)
ISMP noted that more than half of the 1,200 survey respondents
at the executive and staff levels (excluding those who were
pharmacists) believed that, to protect patient safety, employees
who make fatal or repeated mistakes should incur disciplinary
action or termination. Nurses were the most likely to feel
this way. Such opinions reflect hindsight bias and undermine
efforts to create a nonpunitive culture because they encourage
staff to conceal and fail to report their mistakes and near
misses, especially if they believe their peers share a punitive
attitude toward error. Using an ISMP-like anonymous assessment
of staff beliefs (including those of administration personnel,
pharmacists, technicians, nurses, and quality improvement
and risk management specialists) would give organizational
leaders a true picture of staff perceptions with which they
could craft new policies and procedures. If leaders have a
clear picture of their organization's current environment,
they will improve their chances of moving from a punitive
culture to a nonpunitive one.
- "Governor announces $5.4 million to improve patient safety,"
press release
of December 19, 2001.
- "Hospitals
Face New JCAHO Patient Safety Standards on July 1," JCAHO
press release of June, 28, 2001.
- "Speak
Up: National Campaign Urges Patients to Join Safety Efforts,"
JCAHO
- JCAHO
sentinal event alert.
- JCAHO, "2001 Hospital Accreditation Standards, Standards
and Intents," 2001.
Action Steps for Creating a Culture of Safety
Make it known that safety is a top priority — through action. bevote
resources to safety, manage preventively and proactively, and pay attention
to priorities.
Stop talking about eliminating errors. Human error is unavoidable;
error cannot be eliminated. The focus should instead be on learning from errors.
Deal with the authority gradient and fear. Stop punishing people for
making mistakes, resist blaming frontline staff for system problems, reward
safety decisions regardless of cost, and implement effective command and control
functions without micromanaging.
Develop and enhance data collection systems. Realize that only a small
percentage of organizational problems are known. Develop nonpunitive systems,
make reporting easy and reward it, and develop feedback systems.
Decrease reliance on memory. The probability of omission without reminders
is 1 percent, but when reminders are embedded in the process, the probability
is reduced to 0.3%. This can be done through standardization, automation, checklists,
written protocols, built-in reminders, natural mapping of design of processes,
equipment, and forms.
Decrease reliance on vigilance. The probability of an inspector recognizing
an error is only 10%. Employ constraints, natural mappings, and computerized
functions.
Simplify tasks and reduce or eliminate handoffs. The probability of
error rises with increases in the number of people involved and steps taken
to accomplish a task.
Redesign work processes. Create strategic redundancies, eliminate needless
repetition, and identify gaps in processes.
Provide for reversibility and automatic correction where possible.
Plan for recovery when prevention is not possible.
Reduce the need for calculation. Simple arithmetic mistakes can be
the cause of error. Use preprinted charts, automation, double-blind checks,
and calculators.
Provide adequate training. Use simulation to train, have error drills,
and practice failures as well as successful scenarios.
Incorporate ergonomic/human factor design principles in processes. Consider
lighting, noise level, unnatural workflow, clutter, and distractions.
Manage fatigue. Implement reasonable work schedules, limit work hours,
provide breaks, provide adequate staffing, and recognize and make adjustments
for the overstressed employee.
Pay special attention to devices. Include potential users in product
evaluation, pilot new devices, provide training before introduction, time the
introduction appropriately, and eliminate "rigging" of a device.
JCAHO Patients Safety Goals
(Effective January 1, 2003)
Accuracy of patient information
- Use at least two means to identify patients when taking
blood samples or administering medications or blood products.
- Conduct a final verification process, or a "time out" during
a surgical or invasive procedure to confirm the correct patient,
procedure, and site.
Effectiveness of communication among caregivers
- Verify verbal or telephone orders by reading back the complete
order.
- Standardize abbreviations, acronyms, and symbols used in
the organization.
Safety of using high-alert medications
- Remove concentrated electrolytes from patient care units.
- Standardize and limit the number of drug concentrations.
Wrong-site, wrong-patient, and wrong-procedure surgery
- Create a preoperative verification process.
- Mark the surgical site and involve the patient in the marking
process.
Safety of infusion pumps
- Ensure free-flow protection on all general-use and patient-controlled
analgesia intravenous infusion pumps.
Effectiveness of clinical alarm systems
- Ensure regular preventive maintenance and testing of alarm
systems.
- Ensure that staff activate alarms with appropriate settings
and that they are sufficiently audible from distances and
with competing noise in the area.
Copyright © 2002 by the Catholic Health Association of the United States
For reprint permission, contact Betty Crosby or call (314) 253-3477.