CHAPTER 3
Quality, Safety, and Performance Improvement
KEY POINTS
1 Quality is the degree to which health services increase the likelihood of desired health
outcomes.
992 Every physician assumes responsibility for safety and excellence of care in their own
practice environment.
3 Communication problems are the most frequently identified root cause of serious
adverse events in hospitals.
4 Drills and rehearsals for emergency situations improve outcomes and enhance safety.
5 Disruptive behavior in the hospital setting can have adverse effects on patient safety
and overall quality of care.
6 There is mounting evidence that improving quality and safety in health care can
reduce cost and increase value.
WHAT IS QUALITY CARE?
Nearly two decades ago, the Institute of Medicine (IOM) published two seminal
works in the fields of patient safety and medical care quality: To Err Is Human
and Crossing the Quality Chasm (1,2). Despite the heightened awareness and
increased public focus on the crucial issues of quality and safety raised by these
publications, there is limited published evidence of significant progress toward
improving the safety and quality of this country’s health care (3). This slow
progress caused some leaders in the patient safety movement to call for a redesign
of education for health care professionals in order to equip these individuals with
the essential knowledge, skill, and attitude required to function safely and
effectively in the health care delivery environment of the 21st century. Although
this imperative affects all health professions, it is particularly compelling for
medical education because physicians’ actions and decisions dictate the
parameters of care to be provided by most other health care professionals (4).
Recent changes in reimbursement methods for health care services that put a
greater emphasis on value (better clinical outcomes and avoidance of
complications) rather than volume (fee-for-service) are creating more interest in
clinical performance improvement (5).
[1] The IOM defined quality as “the degree to which health services for the
individual and populations increase the likelihood of desired health outcomes
. . . consistent with current professional knowledge” (6). This assertion
acknowledges that health care quality is important and applicable to entire groups
of people and each individual patient. Implicit is the obligation to be sensitive to
the flexible meaning of “desired health outcomes” because desired outcomes may
differ from the perspective of hospitals, physicians, patients, and their families.
Adherence to the definition includes rigorous application of accepted standards of
knowledge and therapy to any clinical problem, a process now referred to as
evidence-based medical practice (7). The IOM summarizes its definition of
quality care in “Six Aims for Improvement” (Table 3-1).
100Patient-Centered Care
Many industries have recognized that one of the best definitions of quality is
meeting customer expectations. The “centering” of patient care requires a focus
on meeting appropriate expectations. The involvement of patients in health care
decision making is traditionally restricted to the legal requirement for informed
consent where the discussion tends to be limited to the benefits and risks of a plan
or procedure. A more complete discussion of individual expectations, appropriate
patient preferences, and the inclusion of all reasonable alternatives for care
encourages a more collaborative process.
The PREPARED checklist (Table 3-2) is one method that may be used for
guiding informed collaborative choice and patient-centered care (Table 3-2) (8).
Table 3-1 Six Aims for Quality Health Care
Care should be:
Safe (first among equals) Timely
Effective Efficient
Patient-centered Equitable
Clinical Variation in Patient Care
Individual patients receiving identical diagnoses might not be given identical
treatments. This is known as clinical variation and can be broadly categorized
as falling into two types. One is necessary clinical variation, an alteration in
medical practice that is required by the differing needs of individual patients. This
modification may be in response to differences in the patients themselves because
of age, overall health status, or other clinical characteristics; or it may be caused
by differing desired outcomes as part of a patient-centered approach to care (9).
This kind of variation is expected in any system of care. The other type is
unexplained clinical variation, which comprises differences in medical care and
patient management that are not accounted for by differences in patient
symptoms, objective findings, or patients’ goals for care. These treatment
discrepancies could account for wide variations in the cost of care without
any demonstrable difference in outcomes as measured by achievement of
therapeutic goals, morbidity, or mortality (10–12). Often this unexplained
variation is the result of management choices made by physicians in cases that fall
into areas of discretion in clinical judgment, where no single course is clearly
correct. Sometimes this variation is unexplained and unintended. It is this
101unexplained or unintended variation that is considered one of the greatest barriers
to the delivery of consistent, high-quality care (13). The specialty of gynecology
is subject to this treatment inconsistency. Significant geographic variations in
hysterectomy rates, largely unexplained by the clinical characteristics of those
local populations, have been reported (14,15). Further study and reduction of
unnecessary variation in these rates could contribute to making medical care more
efficient and equitable.
Table 3-2 PREPARED Checklist Process for Informed Communication and PatientCentered Care
Plan: Course of action being considered
Reason: Indication or rationale
Expectation: Chances of benefit and failure
Preferences: Patient-centered priorities
Alternatives: Other reasonable options/plans
Risks: Potential harms from considered plans
Expenses: Direct and indirect costs
Decision: Fully informed collaborative choice
Role of Organizational Leadership
[2] Creating a safe environment for the delivery of medical care requires the
active participation of organizational leadership. Each physician assumes a
significant responsibility for safety and excellent care in his or her own
practice environment. Inadequate leadership around safety issues erodes
physician and staff morale and can contribute to the occurrence of patient
harm and adverse clinical outcomes (16). In the hospital, oversight for issues of
safety and quality is shared by the hospital board, executive leadership, and
medical staff leadership, including physicians who serve as chief medical officer,
vice president of medical affairs, or department chairs. A new position being
adopted by many hospitals is the patient safety officer (17). This individual takes
direct responsibility for overseeing all aspects of the hospital patient safety
program and reports to the hospital chief executive officer or board of directors. It
is an emerging role for physicians who want to make patient safety the focus of
their professional lives.
102An important method for improving the safety environment in a hospital is the
adoption of the tenets of a safety construct referred to as “Just Culture” (18). Just
Culture recognizes that human error cannot be completely eliminated from
any complex system such as health care. People sometimes make mistakes.
They can be held accountable for following procedural rules to reduce harm to
patients resulting from human error. Adverse outcomes and near misses
encourage the organization to examine its processes of care with an eye to
continuous improvement. With such a system in place, the reporting of safety
problems and concerns will often increase dramatically. This permits the
hospital or other health care organizations to initiate programs that address these
issues and make “first, do no harm” a priority.
Communication
[3] An assessment of the factors leading up to serious adverse events in
hospitals revealed that communication problems were the most frequently
identified root cause, occurring in almost three-fourths of cases (19). Assuring
clear and timely communication between all caregivers is perhaps the single most
important measure to improve the safety and quality of medical care. Structured
communication techniques in the health care setting are referred to under the title
“team resource management.” The basic principle of team resource management
is to foster an atmosphere conducive to enabling individuals with different roles
to achieve a successful outcome to a complex operation (20). Despite differing
roles, training, and ranking within a perceived hierarchy and the inclusion of
some individuals who may not have worked together as a team before, it is
understood that each participant shares an overarching responsibility. That
responsibility is to communicate with all team members whenever they see
anything that is potentially unsafe or when other team members are not acting
appropriately in a given situation. This concept is particularly applicable in the
operating room, which is by nature a highly complex environment. Everyone
present—physicians, nurses, house staff, and technicians—must keep patient
safety foremost in their minds. No one should hesitate to raise questions and
concerns when an unsafe situation is observed.
Certain situations in health care are particularly prone to
miscommunication. One example is during the stress of emergency situations,
when a physician may be rapidly ordering medications, blood transfusions, or
initiating procedures. A technique referred to as “call-outs” helps ensure that
critical orders are correctly received. The person to whom the verbal order is
directed repeats the order verbatim to acknowledge that it is accurately received
and accepts responsibility for carrying it out. Hearing this call-out assures the
ordering physician that the order was received, who will be performing it, and
103creates an opportunity to correct the order if it was misheard. Telephone orders
are well known to be sources of misinterpretation of physicians’ treatment
intentions (21). Check-back is a technique to minimize errors in this medium. In a
typical situation, a doctor calls a nurse to order a medication for a patient. Checkback has three components. First, the physician gives the medication order to the
nurse. Second, the nurse repeats the order back to the physician, specifying
medication name, dose, route, and timing of administration. Lastly, the physician
confirms to the nurse that the order was correctly received. When a handoff of a
patient from one physician to another occurs, that presents a third opportunity for
miscommunication. A relay team approach to care is occurring more frequently in
medical education as a result of residency work-hour restrictions (22). To
minimize errors in this setting, it is wise to use a structured script for
communicating critical clinical information. One such script is from a program
published by the Agency for Healthcare Research and Quality (AHRQ) called
Team Strategies and Tools to Enhance Performance and Patient Safety
(TeamSTEPPS). It is the mnemonic I PASS the BATON, which is essentially a
checklist of clinical items to be related to the person assuming the care of the
patient (Fig. 3-1) (23). The key point is that management handoffs should be a
formal process that does not rely on memory to convey crucial information.
104FIGURE 3-1 I PASS the BATON. (From Team STEPPS Program of the U.S. Agency for
Healthcare Research and Quality [AHRQ]).
An important feature of team resource management is the ability of any
team member to “stop the line”—that is, to halt the process or procedure
when they perceive a risk to patient safety. One recommended technique is the
“CUS” method. This acronym represents three possible sets of “code words” that
any team member may use to stop the procedure until the safety concern is
addressed. The letters in the acronym stand for “I’m Concerned”; “I’m
Uncomfortable”; and “I have a Safety concern.” Another method is the “Two-
105Challenge Rule.” This indicates that when a team member has a safety concern,
he or she should bring it to the attention of the physician in charge of the
procedure. If the concern is not acknowledged or adequately addressed, the team
member should address it a second time. If the concern is still unanswered or
uncorrected, the team member is obligated to go up the chain of command to a
supervisor or higher-ranking physician to have his or her concerns satisfied.
All of these techniques can contribute to a safer environment for patient care in
the operating room, emergency department, and in hospital rooms. However,
none of them can be very effective without practice. [4] The use of drills and
simulations in training programs to rehearse these techniques in mock emergency
situations in anesthesia (24) and other surgical disciplines (25,26) is well
established. The use of simulators to teach basic surgical techniques including
laparoscopy and robotic surgery are becoming more common (27,28). Drills and
rehearsals for emergency situations improve outcomes and enhance safety
(29,30).
Operating Room Safety
The operating room is by its nature a highly complex health care
environment. It is a potential site for adverse events, which can be
catastrophic. These include wrong patient surgeries, wrong site surgeries,
and retained foreign objects. All of these occur in hospitals, despite recognition
that these events should never take place (31,32). The Joint Commission, a
national accrediting body for hospitals, has developed the Universal ProtocolTM
that all surgeons and operating rooms should follow (33). There are three major
components of the Universal Protocol. First is to conduct a preprocedure
verification process that confirms the identity of the patient and his or her
understanding of what procedure is to be performed. Second is marking of the
operative site by the surgeon, which is especially critical in cases involving
bilateral structures. This is to be done in the preoperative area with the patient
awake as a confirmation of accuracy. Third is the performance of a surgical
“time-out” in the operating room prior to the start of the surgery to confirm the
correct patient identity and correct planned procedure. Failure to perform any of
these steps increases the risk of performing the wrong operation on the
wrong patient.
The traditional use of checklists resulted in dramatic increases in the safety of
aviation (34). Their use in medicine is demonstrated to significantly decrease
complications when used consistently to verify that procedural steps are not
overlooked. A simple five-step checklist for central-line placement in the
intensive care unit was shown to reduce the incidence of catheter-related sepsis to
106almost zero (35,36). Similarly, checklists are advocated for use in the surgical
suite to ensure that critical steps for error prevention and patient safety are not
overlooked. The World Health Organization (WHO) released a surgical checklist
in 2009 under their “Safe Surgery Saves Lives” program (37). It involves items to
be reviewed and documented before the induction of anesthesia, before the skin
incision, and before the patient leaves the operating room. Use of the WHO
checklist was shown to reduce major complications of surgery from 11% to 7%
and the major surgery inpatient death rate from 1.5% to 0.8% (38). The use of
checklists such as this to improve patient safety in the operating room should
become more widespread.
The inadvertent retention of foreign bodies such as sponges, instruments, or
other objects at the conclusion of surgery is a continuing source of patient harm.
Risk factors associated with retained foreign bodies are emergency surgery,
unexpected change in surgical procedure, high patient body mass index (BMI),
and failure to perform sponge and instrument counts (39). Systems must be
established to prevent these occurrences, and surgeons need to be aware of the
contributing risk factors listed above (40). The most commonly retained item is
a surgical sponge. Strict adherence to guidelines for tracking surgical
sponges is necessary to reduce the incidence of this serious complication. One
comprehensive program to assist in adherence is called “Sponge Accounting”
(41,42). It involves standardized counting and recording of sponges at the start of
the case and as additional sponges are added to the surgical field. At the
conclusion of the surgery, all sponges are placed in special transparent holders to
allow visual confirmation that all sponges were taken out of the patient. Other
systems employ radiofrequency tagging of all sponges so that retained sponges
can be detected easily before the surgical wound is closed (43).
Application of Safety Technology
Computerized physician (prescriber) order entry system (CPOE) is a prescription
ordering system where the prescriber enters ordering information directly into a
computer, typically as part of a hospital or office electronic medical record. Most
modern systems can check for errors and make suggestions based on
preprogrammed guidelines and protocols. CPOE is known to reduce serious
medical errors and prevent otherwise undetected adverse drug events (ADEs)
(44). When CPOE systems are properly designed and implemented, they can
improve workflow efficiency by supplying real-time dosing information and other
decision-support protocols and guidelines. Poorly designed or improperly
implemented CPOE systems, however, have the potential to decrease efficiency
and increase medication error.
Medication safety is a high priority for quality improvement initiatives.
107Avoiding abbreviations that may lead to medication error increases patient
safety (45). Avoiding abbreviations that can be misread is an important and
effective improvement, especially when orders are handwritten. One easily
remembered and important rule about the written medication order is “always
lead and never follow” a decimal point when using zeros. An order that is written
as .1 mg should be written as 0.1 mg—an example of leading with a zero. It can
be very dangerous for the written period to be missed, resulting in 1 mg being
given to a patient rather than 0.1 mg. The leading zero should alert to the correct
dosage. An order that is written as 1.0 mg should be written as 1 mg—never
following with a zero, so that a patient is not mistakenly given 10 mg of a drug if
the period is missing or not seen. Exclusive use of properly designed and
implemented CPOE systems can eliminate misread written orders.
Disruptive Provider Behavior
In 2009, as part of its accreditation standards, the Joint Commission proposed that
all health care organizations with professional staffs develop and implement a
Code of Conduct Policy along with an education program that addresses
disruptive behavior.
[5] Disruptive physician (provider) behaviors include inappropriate conduct in the
hospital setting, resulting in conflict or confrontation. These behaviors can range
from verbal or physical abuse to sexual harassment. In recent years disruptive
behavior in the hospital setting has become more evident, if not more common.
One study showed that the vast majority of surveyed physicians, nurses, and
administrators had witnessed disruptive behavior by physicians (46). Nurses and
other hospital employees also commit disruptive behavior, but it is far less
common than disruptive physician behavior. Disruptive behavior in the hospital
setting can have adverse effects on patient safety and overall quality of care.
Team building that encourages collegial interaction and a sense that all
members of the health care team are important to the process and present
valuable contributions can promote a culture that reduces the likelihood of
disruptive behavior.
Disclosure and Apology for Adverse Events
Organized medicine is increasing its focus on the prevention of medical
error. A controversial issue involving medical error is the prompt disclosure
and apology for any medical errors that occur. In the past many, if not most,
health care organizations focused on managing the legal risk of medical error. The
conventional wisdom was that any disclosure and apology for error would
promote litigation and bigger payouts. The Joint Commission and other
108professional organizations require or endorse active disclosure to the patient
when adverse events occur, including those caused by error (47).
Lucian Leape, one of the fathers of the modern patient safety movement,
pointed out that a patient has an ethical right to full disclosure of medical error
(48). Although an apology is not an ethical right, it is a therapeutic necessity,
according to Leape. Three programs are worth noting in any discussion of
disclosure and apology for medical error. First is the University of Michigan’s
patient safety program, which addresses the need to disclose medical error in
several publications (49). Important points are made about a patient’s rights
concerning disclosure of medical error and that an apology for errors can be a
productive benevolent gesture rather than an admission of fault. The authors point
out several fallacies about disclosure, including that disclosing medical error
always leads to litigation and that error always means negligence.
Secondly, several programs are under way to test the assertion that disclosure
and apology can decrease the likelihood of litigation. COPIC, a Colorado medical
insurance company, found that full disclosure results in small early settlements
and dramatically reduced law suits and payouts (50).
Table 3-3 Medical Director Responsibilities in an Office Setting
• Motivation of staff to create a “safety culture”
• Credentialing and privileging for office procedures
• Developing/updating/enforcing office policies
• Conducting regular mock safety drills
• Tracking and reporting adverse events
• Establishing a nonpunitive quality improvement process
Lastly, The Sorry Works! Coalition, a coalition of doctors, insurers, and patient
advocates, urges the use of full disclosure and apology for medical errors (51).
They point out that the current tort system has failed, resulting in higher and
higher malpractice premiums without decreasing the rate of medical error.
Demands for caps on malpractice awards and greater disciplinary measures for
providers are largely ineffective. The Sorry Works! Coalition advocates early
disclosure with apology and financial settlements without litigation as the way to
deal with medical error.
Safety in the Office Setting
109Thus far, most efforts to improve safety involved activities that occur in the
inpatient setting. This is a logical initial approach because most risky procedures
and tests are performed in the hospital setting. There is a trend to adapt some
invasive procedures and tests to be offered in the office setting. Gynecologic
procedures such as hysteroscopy and loop excision of the cervix are examples of
this. It is anticipated that there will be increasing numbers of “risky” invasive
procedures performed in the office setting. The American College of
Obstetricians and Gynecologists (ACOG) established a Task Force on Patient
Safety in the Office Setting in 2009.
The charge to the task force was to “assist, inform, and enable Fellows of the
College to design and implement processes that will facilitate a safe and effective
environment for the more invasive technologies currently being introduced into
the office setting.” The task force produced a monograph and an article containing
an executive summary of their work and recommendations (52,53). The task force
addressed issues of leadership in the office setting; competency and assessment;
teamwork and communication; anesthesia safety; measurement (of processes and
outcomes); and tools such as checklists, time-outs, and drills.
In the hospital setting, leadership for safety is provided at multiple levels,
starting with the department chair, with assistance from designated personnel in
risk management and quality assurance. In the office setting, this responsibility
must be assumed by one individual in a solo practice and one or several in a
group practice. One individual should be designated as medical director and his or
her responsibilities are outlined in Table 3-3.
The process of competency assessment should be similar to the credentialing
and privileging systems that hospitals use. The determination that a provider is
qualified (credentialed) and competent to perform specific procedures (privileged)
is equally important in the office setting. Procedures initially performed solely in
an inpatient setting should be converted to the office setting only after the
provider has demonstrated competency in an accredited operating room setting.
Effective communication with office personnel and with patients was
identified by the task force as an essential element for creating a culture of
safety in the office setting. Regular meetings should be held with all office staff
to establish and implement patient safety and quality improvement protocols.
Anesthesia safety is critical for avoiding adverse outcomes in the office setting.
As office-based procedures become more invasive, many practices have
incorporated certified anesthesia personnel into the office team. The level of
anesthesia achieved, not the agents used, should be the primary issue regarding
anesthesia safety. When nonanesthesia-certified providers are managing the
patient, appropriate credentialing and privileging should be documented.
The task force strongly recommends the use of checklists, drills, and time-
110outs to verify the appropriate progress of office-based procedures. Checklists
improve safety and effectiveness in other industries besides health care (34,36).
Verifying that the correct procedure is being performed on the correct patient
during a time-out for confirmation is useful in the office setting, and drills and
simulations are essential activities in high reliability organizations. Advances in
technology are expected to move many more invasive procedures into the office
setting, and patients and providers will expect that these are performed with high
reliability and safety.
Through the Presidential Task Force Report, ACOG provided a blueprint for
improving patient safety in the office setting (52,53).
High Reliability
Patient care delivery is often as consequential and error prone as running a
nuclear power plant or operating an aircraft carrier. The science of high reliability
which is applied in those two activities is being introduced into health care,
particularly in the hospital setting. The ability to operate highly complex and
hazardous technologic systems essentially without error over long periods of time
is the hallmark of a “High Reliability Organization” (54,55). Using techniques
such as simulations, checklists, and situational awareness, delivery of care is
increasingly managed by medical teams who work together to reduce medical
error to very low levels (56). The concept of “Six Sigma” is meant to define an
ideal of restricting errors to one error in about one million events (57). Although
this may be an unreachable goal in something as complex as patient care, the
concept is meant to establish a very high standard.
A Process for Performance Improvement
Professional organizations like ACOG and others have been partnering with their
fellows and fellows’ institutions to address clinical performance issues such as
high cesarean delivery and other surgical rates by organizing courses in basic and
advanced patient safety. One protocol that has been successfully implemented in
ACOG’s advanced course is illustrated in Table 3-4. The protocol outlines and
emphasizes the need for proper planning of any performance improvement effort
and the need for ongoing monitoring in order to sustain the positive changes.
Participating leadership teams have used these worksheets to create a roadmap for
institutional change to achieve a variety of goals in patient safety and quality
improvement.
The Business Case for Quality and Safety
[6] How can the application of the quality and safety principles outlined
111above result in cost savings in the delivery of health care? The business case
for quality and safety is built on the concept of the elimination of waste in
medical care. Brent James, executive director for the Institute for Healthcare
Delivery Research at Intermountain Healthcare in Salt Lake City, identifies two
main types of waste in health care (58). The first is quality waste, which can be
thought of as rework or scrap. This is the failure to achieve the desired outcome
of medical care the first time around. This would include such diverse events as
medication errors that result in patient harm, hospital-acquired infections, wrong
site surgeries, and retained foreign objects at surgery. The second type is
inefficiency waste. This refers to excessive resource consumption to achieve an
outcome when a different alternative is available to more efficiently achieve a
similar outcome. An example would be performing an inpatient hysterectomy for
menorrhagia that could be treated equally well with outpatient medication or
endometrial ablation. James estimated that together these two sources account for
as much as 50% of the expenditures on health care in this country (58). While
many experts considered this a wild exaggeration, this view was given some
credence in 2012 in a comprehensive review of the American health care delivery
system by the IOM (59). This publication estimated that in 2009, waste in the
medical delivery system resulted in the loss of $750 billion from productive use,
enough to provide health insurance coverage to 150 million people. The
conclusions from this group are shared by proponents of value-based delivery of
patient care (60), where emphasis is put on obtaining the best clinical outcomes
while using the most efficient amount of resources (the value equation). The
Centers for Medicare and Medicaid (CMS) have adopted payment methods that
are based upon this value equation (61). Combating all sources of wasted health
care dollars will require a widespread adoption of the principles discussed: the use
of evidence-based medical treatments and safety technology; the elimination of
unexplained clinical variation in our processes of care; the direct involvement of
patients in monitoring their own care; improved teamwork and communication
between providers in different disciplines; and all of these under the guidance of
committed health care leadership able to rally support for these efforts. The twin
aims of improving the safety and quality of medical care are goals that all
physicians should actively pursue.
Table 3-4 ACOG Process of Performance Improvement*
Nhận xét
Đăng nhận xét