pass legislation to extend peer review protections to data related
to patient safety and quality improvement that are collected and
analyzed by health care organizations for internal use or shared
with others solely for purposes of improving safety and quality.
As noted throughout
the IOM report, solutions unique to one individual are essentially
irrelevant. It is the system-wide, generalizable approach that is
the cornerstone to success. The question "Who did it?"
is not important. However, it is critical to find out what happened,
why it happened, and how it can be prevented in the future.
of a successful reporting system are that those who report must
feel safe in doing so and that their confidentiality must be protected.
Reporting systems in which these factors are missing are generally
unsuccessful in obtaining data, inaccurate, and incomplete. The
experience of the aviation industry speaks to the importance of
a confidential, blame-free reporting environment. The FAA and others
have found major increases in reporting by removing the identity
of the institution submitting the report.
On January 14,
2000, President Clinton acknowledged these characteristics of successful
safety reporting systems when he announced a program that will provide
immunity from punishment to airlines' personnel when they report
to the FAA operational and procedural errors that threaten passenger
safety. The program's goal, much like that of patient safety systems,
is to identify trends early and address them before they cause harm
is committed to providing appropriate protections for data in the
system, but the protections will depend on the nature of the data
and reporting systems. Such statutory protections already exist
in the Medicare program for mandatory reporting to the program's
Peer Review Organizations (except when used in criminal investigations).
These protections should be extended to protect voluntary reporting
to achieve the greatest level of learning. The specific details
of the appropriate legal protections must be negotiated with Congress,
the industry, and States.
has focused on developing reporting systems for learning that deal
with system-wide, rather than individual, performance issues. It
is important to understand that individual performance issues are
best addressed through credentialing, licensing, and other administrative
mechanisms. The QuIC expects that will continue to be the case.
However, it is important to note that safety reporting systems should
never become a shield from necessary actions to address criminal
activity or deliberately unsafe acts. The obligation to report these
activities still exists, and mechanisms to address those issues
should be maintained. For example, the Health Resources and Services
Administration (HRSA)-sponsored National Practitioner Data Bank
records disciplinary actions taken against providers. It is maintained,
in part, to help institutions carry out their responsibility for
patient safety by searching for and reviewing records of applicants
who are seeking staff appointments.
- The QuIC
supports the extension of peer review protections to facilitate
reporting of errors in a blame-free environment, and will propose
considerations of confidentiality that will not undermine current
mechanisms to address criminal activity or negligence.
- As part the
development of the national reporting system, appropriate electronic
protections (i.e., firewalls and encryption) will be constructed
to ensure that the confidentiality of the patients involved and
the clinician or institution providing the information is maintained,
and that the information gathered will not be used for punitive
purposes. Experience with reporting systems in other industries
demonstrates that this approach encourages reporting of errors.
Performance Standards and Expectations for Safety
Standards for Health Care Organizations
standards and expectations for health care organizations should
focus greater attention on patient safety.
and accreditors should require health care organizations to implement
meaningful patient safety programs with defined executive responsibility.
- Public and
private purchasers should provide incentives to health care organizations
to demonstrate continuous improvement in patient safety.
member organizations are involved with regulation and accreditation.
Some are also health care purchasers. A major purchaser of health
care, HCFA, intends to require hospitals in the Medicare program
to have an effective internal error reporting system and an effective
evidence-based error reduction program for all patients as necessary
components for certification and accreditation. The State survey
agencies, acting as HCFA's contractors, and the hospital accreditation
organizations, will monitor whether activities to reduce medical
errors are occurring in Medicare participating hospitals. Enforcement
actions will be taken only if such activities are not occurring.
HCFA will conduct research and pilot studies or demonstrations in
nursing homes, where experience with error measurement is more limited
but the need may be equally great.
Conditions of Participation (CoP) for hospitals participating in
Medicare require that the hospitals meet State laws, which includes
error reduction systems. Thus, Medicare rules support existing State
requirements for confidential reporting, whether voluntary or mandatory.
The Health Care
Financing Administration will publish regulations this year requiring
the over 6,000 hospitals participating in the Medicare program to
have ongoing medical error reduction programs that would include,
among other interventions, mechanisms to reduce medication errors.
In order to comply with this new regulation, hospitals may choose
to implement automated pharmacy order entry systems, include automatic
safeguards against harmful drug interactions and other adverse side
effects built into the treatment process, or institute decision-support
both public and private, have leverage to stress the importance
of a safe environment in which to deliver patient care. This leverage
must put a premium on medical error reduction through identification,
systems approaches to resolution, and assessment of overall effectiveness.
Both through its own purchasing power and by working closely with
private purchasers, HCFA will institute financial and burden-reduction
incentives to move providers to create a safer health care environment.
In addition, HCFA, as a purchaser, will work with and support accreditation
organizations' efforts to set standards for patient safety, to measure
and report results, and to use these standards in their purchasing
decisions. The Office of Personnel Management (OPM) will require
that all plans with which it contracts be accredited by organizations
that include evaluation of patient safety programs in their accreditation
- HCFA will
use its power as a purchaser and regulator to promote the use
of effective error-reduction initiatives in the health care institutions
with which it deals.
- HCFA will
publish regulations this year requiring hospitals participating
in the Medicare Program to ongoing medical error reduction programs.
- OPM will
follow the lead of selected private purchasers to raise the standard
for participation by requiring that all health plans with which
it contracts seek accreditation from an independent, national
accrediting organization that includes evaluation of patient safety
and programs to reduce errors in health care.
- In its call
letter for the 2001 contract year, OPM will ask health plans to
encourage their preferred hospitals to use automated prescription
systems and other integrated data systems. OPM will encourage
health plans to annotate PPO directories to indicate which hospitals
and physicians' offices use such automated programs.
Standards for Health Care Professionals
standards and expectations for health professionals should focus
greater attention on patient safety.
- Health professional
licensing bodies should:
periodic re-examination and relicensing of doctors, nurses, and
other key providers, based on both competence and knowledge of
Work with certifying and credentialing organizations to
develop more effective methods to identify unsafe providers and
societies should make visible commitment to patient safety by
establishing a permanent committee dedicated to safety improvement.
This committee should:
a curriculum on patient safety and encourage its adoption into
training and certification requirements
Disseminate on a regular basis information on patient safety
to members through special sessions at annual conferences, journal
articles and editorials, newsletters, publications, and Web sites.
The QuIC proposes
that the Federal Government take a lead role in fostering patient
safety efforts through a concerted program in support of error reduction
and improved safety. HRSA, HCFA, VA, DoD, OPM, and all other Federal
agencies that provide or sponsor health services will collaborate
in a five-part program to foster a reduction of medical errors and
to promote health care quality This program will include:
that directly impact health care quality in the community: HRSA,
HCFA, OPM, and VA, with other appropriate agencies will foster
community and professional programs that increase quality of health
care (such as DQIP, the recently developed Diabetes Quality Improvement
Project) and decrease errors (for example, pharmacy prescription
surveillance programs). HRSA will use the Area Health Education
Center (AHEC) Program and other programs that affect continuing
professional education in the community to increase such error
reduction and quality promotion programs.
- Quality Infrastructure
Development: Agencies such as DoD and VA, together with other
agencies as appropriate, will develop studies and tools for error
detection and reduction. These tools will reflect both internal
experience as well as other scientific and evidence-based information.
- Health Professionals
Education and Training: HRSA, HCFA, and other Government agencies
will foster development of courses and training materials that
promote error reduction and patient safety by providing incentives
through grants and contracts for the development of new curricula
in health care quality and error reduction methodologies. These
will explore clinical training programs that could incorporate
the simulation models tested by VA, DoD, and others to reduce
error in clinical training programs and the use of CDC's Epidemic
Intelligence Services (EIS) as a model.
and Certification: The QuIC will convene a meeting of accrediting,
licensing, and certifying bodies to propose, investigate, and
evaluate educational methods to improve analysis, understanding,
and prevention of medical errors. This will also include collaboration
with the Federation of State Medical Boards and others to encourage
education in these areas as a component of relicensing. HRSA,
in coordination with State governments and other agencies involved
with licensing and certification bodies, will assist licensing
bodies to assure continuing competence among practitioners and
to take appropriate actions to protect against unsafe providers.
This will include provision for error-prevention education as
part of the relicensure process.
Assistance: The QuIC will provide technical assistance to State
or professional agencies seeking to ensure a basic level of knowledge
for health care providers on patient safety issues, promote model
patient safety programs that include evidence based best patient
safety practices to provider organizations, or help agencies implement
the cultural change necessary to make reporting systems a success.
of such a four-part program include community quality measures,
infrastructure development, health professional training, and licensing
and certification measures. These programs will be carried out cooperatively
by involved public- and private-sector institutions.
The QuIC will:
- Develop and
evaluate programs introducing health professionals to errors analysis
and the challenges of practicing in a technically complex environment,
explore the use and testing of simulators and automation as education
tools, support training in errors research and evaluation, and
develop patient safety expertise at the State level using the
CDC's Epidemic Intelligence Service as a model.
- Convene a
meeting of the accrediting, licensing, and certifying bodies of
the health professions to review information on medical errors
in the context of current practice requirements and propose methods
of strengthening health professions' education in the areas of
medical error prevention and medical error evaluation as a means
of improving patient safety.
with the Federation of State Medical Boards and other entities
to encourage that error reduction and prevention education be
a provision for relicensing of health professionals.
in the planning, implementation, and evaluation of a national
summit addressing patient safety and medical error reduction programs,
and in producing directives for the future.
- Provide training
within the QuIC agencies that provide care to encourage use of
patient safety information and encourage enhanced reporting in
partnership with private-sector accreditors, purchasers, and providers.
- Provide technical
assistance to State or professional agencies seeking to ensure
a basic level of knowledge for health care providers on patient
of Drugs and Devices
The Food and
Drug Administration (FDA) should increase attention to the safe
use of drugs in both pre- and postmarketing processes through the
- Develop and
enforce standards for the design of drug packaging and labeling
that will maximize safe use.
- Require pharmaceutical
companies to test (using FDA-approved methods) proposed drug names
to identify and remedy potential sound-alike and look-alike confusion
with existing drug names.
- Work with
physicians, pharmacists, consumers, and others to establish appropriate
responses to problems identified through postmarketing surveillance,
especially for concerns that are perceived to require immediate
response to protect the safety of patients.
The FDA works
to ensure the safety and effectiveness of medical products, including
drugs, medical devices, and biological products such as human blood.
In May 1999 the FDA published a report, Managing the Risks from
Medical Product Use, that evaluated its role in medical safety
and discussed options for further improvements. The report emphasized
the systems nature of medical safety and the role of the many stakeholders
in the safety chain.
FDA is responsible,
in conjunction with Institutional Review Boards, for oversight of
patient and volunteer safety in clinical trials of investigational
medical products. To this end, FDA reviews clinical protocols conducted
under Investigational New Drug Applications and Investigational
Device Applications, monitors the adverse events occurring in trialsreporting
adverse events is mandatory for investigators and trial sponsorsand
requires modification or cessation of trials when patient safety
is an issue.
FDA has promulgated
extensive safety criteria that medical products must meet prior
to marketing. Drug, devices, and biological products must undergo
laboratory and clinical testing and meet safety standards before
approval. In addition to toxicological and human safety testing,
these criteria include design controls and human factors testing
for medical devices, and requirements for naming, packaging, and
labeling pharmaceuticals. Strengthening criteria aimed at reducing
name confusion, dosage errors, and device misuse, or improving comprehension
of the product information, would reduce product-related errors.
Improving product safety requirements will require additional research
and collaboration with health care delivery systems, health care
professionals, Government agencies, and manufacturers. Additional
work could be done to implement human factors testing in the evaluation
of medical devices, and to institute such testing for pharmaceuticals.
Threats to patient
safety from medical products can arise from unsafe products or from
unsafe use of medical products. Despite extensive premarket safety
evaluation, unanticipated errors do occur as medical products are
used in the health care system. Although FDA is extensively involved
in the detection and prevention of such errors, many more steps
can be taken to increase the safe use of these products. For example,
FDA has completed Phase I of implementing the Congressionally mandated
Medical Product Surveillance Network (MedSuN), an active reporting
network. FDA now wants to implement a large-scale Phase II study
that will allow the dissemination of data regarding emerging device
problems to health care professionals and the public.
engages in numerous outreach efforts, more safety information, in
a more useful form, needs to be provided to users of medical products.
Similar opportunities for increased efforts exist in the areas of
risk detection, data analysis, risk management, and risk communication.
The FDA, as outlined in the action items below, will take steps
to increase its capacity to detect errors, investigate and understand
them, and prevent further occurrences. The knowledge gained in these
investigations can also be incorporated into premarket review activities,
thus preventing repetition of errors with new medical products.
Within 1 year,
the FDA will initiate programs to:
- Develop additional
standards for proprietary drug names to avoid name confusion.
- Develop standards
for packaging to prevent dosing and drug mix-ups.
- Develop new
label standards for drugs, highlight drug–drug interactions, potential
dosing errors, and address other common errors related to medications.
the Phase II pilot study of the Congressionally mandated Medical
Product Surveillance Network (MedSUN).
efforts to ensure manufacturers' compliance with FDA programs,
specifically naming, labeling, and packaging.
- Provide access
to databases linked to health care systems and other sources of
adverse-event and marketing data, and link these to existing registries
of product users.
the on-line Adverse Event Reporting Systems (AERS) for drugs and
FDA's analytical and investigative capacities.
FDA outreach activities and collaboration with other Government
agencies and stakeholders.
Safety Systems in Health Care Organizations
organizations and the professionals affiliated with them should
make continual improvement in patient safety a declared and serious
aim by establishing patient safety programs with defined executive
responsibility. Patient safety programs should:
- Provide strong,
clear, and visible attention to safety.
nonpunitive systems for reporting and analyzing errors within
well-understood safety principles, such as standardization and
simplification of equipment, supplies, and processes.
interdisciplinary team-training programs for providers that incorporate
proven methods of team training, such as simulation.
institutions should implement proven medication safety practices.
communication is critical in building trust in the population from
whom reports are expected. Systems perceived as punitive or exposing
individuals or institutions to legal liability have proven to be
much less effective than desired. For example, JCAHO has experienced
significant difficulty in securing hospitals' participation in its
"sentinel events" reporting system because of worries
surrounding legal vulnerabilities or punitive actions.
influencing the success of safety programs is the level at which
organizational responsibility is established. Experts suggest that
safety programs within individual organizations or institutions
are most effective when reporting is at the level of the chief executive
officer. Responsibility and reporting at the level of the CEO makes
the issue of organizational accountability clear. It ensures that
patient safety has the attention of the highest levels of the organization.
It sends a clear message throughout the organization that safety
is a priority, and it helps remove the inherent conflicts of interest
that may occur if the reporting occurs at lower levels.
agencies have already undertaken the task of creating meaningful
patient safety systems within their health care delivery organizations.
VA has an exemplary patient safety program, and the DoD is developing
one that is modeled after that of VA. The National Institutes of
Health's Clinical Center has a long standing "Occurrence Reporting
System" to report unanticipated patient care events. Further
refinements of each system will be made.
the QuIC will be working with the Institute for Healthcare Improvement
(IHI) to create an initiative that will test several strategies
for rapidly reducing the number of errors committed. Our effort
will be targeted specifically at health care delivery settings where
patients are in need of urgent assistance and decisions have to
be made rapidly, which we are calling "high-hazard environments."
These would include emergency departments, operating rooms, intensive
care units, and on-site rescue operations. This is the first such
initiative targeted at error reduction in these high hazard environments.
Based on the results of previous IHI initiatives, it is hoped that
some sites will be able to achieve reductions of 25–30 percent in
the number of errors within 12 to 15 months. The findings from this
Federal effort will be shared broadly to help other organizations
reduce errors in their own health care delivery settings.
technology offers other opportunities for the reduction of medical
errors and is discussed in Chapter
- Under the
leadership of the CQuIPS, the QuIC will promote, at the executive
level, the development and dissemination of evidence-based, best
patient-safety practices to provider organizations.
- QuIC participants,
including HCFA, VA, DoD, AHRQ, CDC, and FDA, will explore opportunities
with private-sector accreditation, purchaser, and provider organizations
to develop organization-based, patient-safety models that could
be evaluated, and if found effective, disseminated widely. In
addition, these stakeholders will be engaged in a regular dialogue
with QuIC participants to ensure that the stakeholders'organizational
needs are being met through Federal research and reporting initiatives.
- Through its
exemplary patient safety program, VA will continue to scrutinize
its care provision for opportunities to improve safety, and develop
and expand its reporting system.
- VA will invest
$47.6 million this year to increase patient safety training for
staff (details in Chapter 3).
- DoD will
invest $64 million in FY 2001 to begin implementation of a new
computerized medical record system, including an automated order
entry system for pharmaceuticals (details in Chapter
- Other QuIC
direct-care providers will initiate patient safety programs (e.g.,
HRSA's community health care centers are investigating the most
effective programs that can be implemented in their health care
- QuIC member
agencies will begin a collaborative project this summer with the
Institute for Healthcare Improvement to reduce errors in high-hazard
health care delivery settings.
for Reporting Systems
Data collected for one purpose are not easily used for another.
Need clear definitions, easy mechanisms for reporting, system capable
of using data for intended purpose (1).
incentive (e.g., return of valuable information) to ensure
need to be protected from discovery.
include near misses likely to lead to major adverse event.
must see it in self-interest to report.
of database contingent upon willingness to report.
include near misses likely to lead to major adverse event.
aspect could be the review (i.e., audit) of the safety and
error analysis process.
systems already exist for high interest/high profile adverse
best for events that are difficult to overlook.
- Not applicable
because no one would agree that something truly voluntary
is a basis for accountability.
Any criminal act identified through reporting systems will be handled
with appropriate mechanisms.
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