Clinical Process Improvement

Nermin Mahmoud Ghith

B.S., PGDip.TQM, C.P.H.Q
Healthcare Quality Consultant
Nermin_ghith@hotmail.com
 The key issue in quality planning is to
know that such standards and practice
guidelines exist and are available for use
by organizations in treating patients and
establishing performance measures.
 The improvement of performance in
clinical processes is more complex than
improvements in governance,
management, or support processes.
One of the key issues is the addition of the
patient as a variableas supplier,
processor, and customer.
 Other issues include the more
interdisciplinary nature of these processes,
epidemiological differences between
individual patients and patient populations,
the constantly changing technology and
research, and the differences in practitioner
training and experience.
Clinical standards, clinical practice
guidelines, clinical pathways, and
adjustments for severity and complexity of
patient illness and injury offer "state of the
art" support.
 All such guidelines are considered, in
quality improvement language,
"specifications of process" or
"specifications of care, based on the best
scientific evidence of effectiveness
combined with expert opinion.
They describe "typical" treatment for
"typical" patients and provide a framework
for discussing patterns of care for cohorts
of patients (patients with similar risk, co
morbidity, severity of illness, and expected
outcomes).
Definitions and description
 Standard of Care: "A standard of care
defines the type of care/service and
outcome that the patient can expect from
the healthcare encounter."
[Healthcare Quality Certification Board]
 Standard of Practice: "A standard of
practice establishes an acceptable level of
performance."
[Healthcare Quality Certification Board]
 Standards of practice are broad,
generalized statements of expected
practitioner performance, behavior, or
patient care intervention that are accepted
in the community or nationally. They
should not be confused with "practice
guidelines, which are very specific to
patient management of a particular
condition.
 Clinical Practice Guideline (CPG):
The National Guideline Clearinghouse
[www.guideline.gov] employs the definition
developed by the Institute of Medicine (IOM):
Clinical practice guidelines are
systematically developed statements to
assist practitioner and patient decisions
about appropriate health care for specific
clinical circumstances.
 Evidence-Based Medicine (EBM):

Most clinical practice guidelines (CPGs)

are now based upon evidence-based
medicine, defined as the "conscientious, explicit,
and judicious use of current best evidence in making
decisions about the care of individual patients.
The practice of evidence-based medicine means
integrating individual clinical experience with the
best available external clinical evidence from
systematic research." [Sackett, et al, "Evidence-
Based Medicine: What It Is and What It Isn't," BMJ,
1996]
 A great resource: "Evidence-based
Practice," Health Sciences Library,
McMasters University, Canada,
www-hsl.mcmaster.ca/ebm/
Standards of Care
for PHYSICIANS
 CBAHI

MS.57. Clinical practice guidelines are

used to guide the clinical care of the
patient as appropriate.
 For physicians, standards of care are now
best known as clinical practice guidelines.
Clinical "algorithms" and "practice
parameters" also fall within this framework.
A clinical algorithm is a diagram of a
guideline, making a step-by-step decision
tree.
 Clinical practice guidelines generally are
produced by medical specialty associations,
relevant professional societies, public or private
organizations, or government agencies, or result
from a collaborative effort.
Practice guidelines approved by national
professional groups provide clinical rationale for
clinical pathways and performance measures
and should be available through the quality
professional (Quality Resource Center). We
must know where the good resources and data
sources are.
Standards Of Patient Care
For Nursing
 CBAHI
NR.8. The Nurse Leader develops and
maintains a current standard of practice
for each nursing unit (e.g. intensive care,
medical surgical, emergency room).
NR.8.1 There is a unit specific nursing
practice standard.
 NR.65. The Nursing department has policies
and procedures and a competency assessment
program (e.g. written test, return demonstration,
etc.) on an ongoing basis (every two (2) years)
and/or as needed according to staff needs to
ensure that nursing skills and knowledge remain
current. The policies and procedures and
competencies include but are not limited to:
NR.65.1 Monitoring patient vital signs and
knowledge of deviations.
NR.65.2 Assessment/reassessment of patients
according to scope of service (e.g. intensive
care, labor and delivery, etc).
NR.65.3 Medication administration.
NR.65.4 IV therapy (insertion, maintenance,
discontinuing).
 NR.65.5 Infection Control guidelines.
NR.65.6 Patient falls (assessment of risk and methods to
prevent falls).
NR.65.7 Use of pulse Oximetry.
NR.65.8 Nurses role in cardiac/respiratory arrest.
NR.65.9 Nasogastric (N/G) tubes and gastrostomy tubes (GT)
and feedings.
NR.65.10 Urinary catheters.
NR.65.11 Sterile dressings.
NR.65.12 Skin care and the prevention and care of pressure
ulcers.
NR.65.13 Nurses role in disaster, fire, and other emergencies.
NR.65.14 Use of restraints.
NR.65.15 Operation of blood sugar testing equipment.
NR.65.16 How to safely clean up chemical spills.
NR.65.17 Blood and blood product (Phlebotomy and Blood
Administration).
NR.65.18 Documentation.
 JCI standards
The Joint Commission uses the term
"nursing standards of patient care"
in Standard NR.3.10, 2005 CAMH.
Nursing policies and procedures; nursing
standards of patient care, treatment, and
services; and standards of nursing
practice are established by the nurse
executive, registered nurses, and other
designated nursing staff members, defined
in writing, and accessible to nurses in
written or electronic format [NR.3.10, EP 1
& 3].}
 The Standards of Nursing Practice
content, first developed by the American Nurses
Association in 1973, were revised most recently
in 2004.
They consist of:
six "Standards of Practice" (care) and
nine "Standards of Professional Performance," along
with measurement criteria for each standard that are
applicable in any setting
Source: Nursing: Scope and Standards of Practice,
ANA, 2004].
 The ANA Standards of Practice actually
"describe a competent level of nursing care" ,
demonstrated through the nursing process:
Assessment
Diagnosis
Outcomes identification
Planning
Implementation (coordination of care, health teaching
and health promotion, consultation, prescriptive
authority)
Evaluation
 In performance measurement,
important aspects of nursing care are
easily adapted from the established
nursing standards, as are performance
measures.
 The ANA Standards of Professional
Performance cover nine key areas:
Quality of practice,
education,
professional practice evaluation,
collegiality,
collaboration,
ethics,
research,
resource utilization, and
leadership.
The Quality of Practice standard states:
The registered nurse systematically enhances
the quality and effectiveness of nursing
practice." Measurement criteria include:
Documenting in a responsible, accountable,
ethical manner;
Using QI results to initiate changes in nursing
practice and the delivery system;
Using creativity and innovation in nursing practice
to improve care delivery;
Incorporates new knowledge for change if desired
outcomes are not achieved;
Participates in quality improvement activities.
Clinical Practice Guideline
Development
 International practice guidelines offer solid
baseline information for the development
of organization-specific clinical pathways
(clinical management plans).
Practice guidelines help in the
development of clinical algorithms to
support clinical pathways.
 For example, physicians can support the
effectiveness of a clinical pathway for
ventilator-dependent patients by
developing an acceptable weaning
protocol or algorithm.
Another example is physician
development of algorithms for the
prescription of appropriate antibiotics,
based on infectious agent, for patients with
pneumonia who are being treated by the
team in accordance with a pneumonia
clinical pathway
 Clinical practice guidelines are
developed and released by the then U.S.
federal Agency for Health Care Policy
and Research (AHCPR), now called the
Agency for Healthcare Research and
Quality (AHRQ), www.ahrq.gov, between
1992 and 1996.
 They included both a clinician's
reference guide and a patient's guide
and were widely covered in the lay press.
The distribution of most guidelines was
discontinued May 2001, since they are now
considered to be out of date. The 16
discontinued guidelines are available only in
an electronic archive:
www.ahrq.gov/clinic/cpgarchv.htm.
The three guidelines still currentPressure
Ulcers in Adults, Pressure Ulcer Treatment,
and Cardiac Rehabilitationare available at
www.guideline.gov .
 The AHRQ now supports development
efforts by others and sponsors the
National Guidelines Clearinghouse
(NGC), at www.guideline.gov.
The NGC, a partnership effort involving
AHRQ, America's Health Insurance Plans
(AHIP) and the American Medical
Association (AMA), is a publicly available
electronic repository for guidelines and
related materials that have been reviewed
and updated within the last five years by
more than 300 organizations.
 As of July 2006, the repository covers
guidelines under:
1742 Diseases;
160 Mental Disorders
Treatment/Intervention: 958 Chemicals
and Drugs; 1524 Analytical, Diagnostic,
and Therapeutic Techniques and
Equipment (surgical, anesthesia,
diagnosis/ therapeutics, investigative,
dentistry, equipment/supplies); 197
behavioral
 The Integration of Standards
into Practice and Performance
Appraisal
 Physicians are increasingly being called on to
use clinical guidelines.
Scientific studies support their use; resistance to
cookbook medicine is fading out.
External groups i.e. the American Heart
Association to NCQA and JCAHO are
incorporating adherence to guidelines into PI.
Physicians are more apt to use them, with
medicine becoming more complex, as long as
leaders believe in them and they are readily
available at the point of care.
 Standards of care, clinical practice guidelines,
and clinical paths are used increasingly to
generate performance measures/indicators for
ongoing quality management activities.
The emphasis in quality improvement is on the
processes of delivering care, but we cannot
ignore significant findings related to the care and
practice of individual practitioners.
Performance measure results are the basis of
the growing pay-for-performance bonus-
payment programs
 The results of quality management
activities, including adherence to
standards, are documented and reviewed
in conjunction with the reappraisal of all
independent practitioners with delineated
clinical privileges (physicians,
psychologists, dentists, podiatrists, allied
health professionals/limited license
practitioners) that occurs generally every
two years in hospitals, large medical
groups, etc
 The results of quality management
activities within the organization may
also be incorporated into the performance
evaluation process of at least the other
clinical staff or those who directly contact
patients (nurses, therapists, technicians,
medical assistants, health aides, etc.), along
with non-clinical staff, as organization
performance monitoring progressively
includes more governance, management,
and support functions and performance
measures based on standards.
One of the most valuable aspects of this
integration is the inclusion of positive
findings.
 Clinical pathway and
clinical algorithm development
 A clinical path is a patient management
strategy and tool describing the key events in
the process of care for a given diagnosis or
condition that the healthcare team determines
are most likely to result in positive outcomes.
The path describes what interventions an
average patient might require, but allows the
physician to change, delete, or add interventions
to meet each patient's needs.
In this sense a clinical path serves as a patient
management plan, but it is not a standard of
care.
Steps In Clinical Path Development
Prioritizing and defining the patient
population/group;
Identifying the "categories" of care to be
included, as applicable, e.g.:
Consults
Lab Diagnostic Evaluation
Radiology Diagnostic Evaluation
Other Diagnostic Evaluation
Treatments (can be broken out by service)
Nursing care (can be separate or under treatments)
 Medications
Nutrition
Activity
Teaching
Discharge/transition plan
Psychosocial
Expected progress/outcome (for each day of
care or objective)
 Identifying, for the designated diagnosis,
procedure, or condition, the levels and
number of days of care or visits to be
included (e.g., preadmission/emergent,
day one through day five, skilled or home
health, etc.);
Outlining anticipated care requirements
and outcomes for each level/day of care
objective and category, using existing data
or medical record review;
 Testing the accuracy of the clinical path
while care is being rendered, redesigning
as necessary to reduce potential for
unnecessary variation;
Identifying, documenting, and tracking
variances over time, looking for better
practice and continuing redesign as
necessary, or introducing other process
improvements to further reduce variation.
Development of Effective
Clinical Pathway System
 The following issues must
be addressed:
1. The focus diagnoses, procedures,
and/or conditions must be identified,
hopefully by organization leaders, based
on accurate, in-depth analysis of
available data:
Data Types involve:
Long term, determine the percentage of
the patient population to be included;
Patient groups may be selected on the basis
of high volume, high cost, high risk, or
problem-prone data;
In addition to the above data, leaders should
seek to identify those diagnoses, procedures,
and conditions that have wide variability in
processes (management by opinion, not
standard) and obviously need a new process
designed to bring the clinical system under
control.
2. The clinical path must be developed by
a team consisting at the least of all
those who provide direct care to the
identified patient group;
3. The clinical path that is developed should
not change clinical staffing requirements;
4. The clinical path should consider the
entire episode of illness, outlining care
requirements for each care discipline and
each level of care, including ambulatory,
inpatient/alternative delivery, and
aftercare.
 Clinical Pathway Analysis
Truly effective clinical path analysis
will require computerization.
There is currently such a vast score and
mix of variations from the path that hand
tallying and analyzing is tedious and
inadequate for long-term aggregation;
 Many variations from clinical paths stem
simply from the fact that:
Patients are all different; and
The paths probably do not truly represent
"best" practice, and modifications to the path
are necessary (to stabilize the process) as the
first step in reducing variation.
The Value of Clinical
Pathways
 Clinical (or critical) paths (or pathways) are
developed by interdisciplinary teams, in
conjunction with physicians, as a way to:
Identify the important functions,
care processes, and needed services
connected with a particular diagnosis (e.g.,
diabetes), procedure (e.g., total joint
replacement), diagnosis-related group or
other prospective payment reimbursement
group, or condition (e.g., ventilator-
dependent) for each expected day of care
in the hospital or for each stated objective
in primary care or home care;
 Describe patient, material, and information
flow for given diseases/conditions;
Establish a clear mechanismfocused on
the patient and not a
department/serviceto "manage" the
patient through the system;
 Support the organization's identified
important direct patient care processes
prioritized for improvement, particularly
those that are Strategic Quality Initiatives;
Link expected care, based on
incorporation of appropriate practice
guidelines and standards of care, with the
nursing or interdisciplinary care plan;
 Track significant variations from the
path case by case (concurrently) and
over time (in aggregate), to improve care
by modifying the path, improving
associated processes of care, establishing
better or best practices, etc.; [See
presentations related to statistics and
Information Management, for more detail
re. variance analysis]
 Vertically integrate care at all levels from
primary care through the acute inpatient
period to post discharge care and
maintenance of function;
Communicate care expectations to
patients and families and involve them
actively and concretely in the care.
 Clinical paths can facilitate quality
management activities by:

During development, collecting

information about current patient
management practices and identifying
improvement opportunities;
 Improving processes, e.g.:
Timely patient assessment for discharge
needs;
Availability of supplies and equipment;
Timely performance of therapies and
procedures.
Improving communications, e.g., orders,
transports, consultations, discharge;
Reducing variation in physician practice
patterns;
 Offering flow-charted information to
QI Teams for the selected diagnoses,
procedures, and conditions and ongoing
variance tracking after QI actions have
been implemented;
Providing the basis for ongoing, as well as
special, monitoring of diagnoses,
procedures, and conditions. Chart review
can be performed, concurrently or
retrospectively, using the clinical path as
the patient management tool.
 Clinical paths facilitate implementation of
capitated managed care contracts by:
Predicting preadmission/pre-procedure visits,
length of stay, resource use, aftercare, and
expected outcomes for specific diagnoses,
procedures, and conditions for use in marketing
and negotiating with employers, HMOs,
insurance, and other healthcare purchasers; and
Focusing the attention of all care providers on
maximizing each visit or day of care for the
patient, that operationalizes concerns about
costs per visit or day of care, effective use of
resources, and progress toward meeting stated
patient care objectives.
Accreditation
 Both JCAHO and CBAHI require the
selection and implementation of clinical
practice guidelines, along with evaluation
of their effectiveness, based on the
organization's mission, priorities, and
patient populations.
The Joint Commission Standards 2007
LD.5.10 The hospital considers clinical practice
guidelines when designing or improving processes,
as appropriate.
LD.5.20 When clinical practice guidelines are used,
the leaders identify criteria for their selection and
implementation.
LD.5.30 Appropriate leaders, practitioners, and
health care professionals in the hospital review and
approve clinical practice guidelines selected for
implementation.
LD.5.40 The leaders evaluate the outcomes related
to use of clinical practice guidelines and determine
steps to improve processes.
 Standard LD.5.10

The hospital considers clinical

practice guidelines when designing
or improving processes, as
appropriate
Rationale for LD.5.10
Clinical practice guidelines can improve
the quality, utilization, and value of
health care services.
Clinical practice guidelines help
practitioners and patients in making
decisions about preventing, diagnosing,
treating, and managing selected
conditions.
Clinical practice guidelines can also be
used in designing clinical processes or
checking the design of existing processes.
The leaders may
consider sources of clinical practice
guidelines such as the Agency for
Healthcare Research and Quality, National
Guideline Clearinghouse, and professional
organizations.
Element of Performance for LD.5.10
The leaders have considered the use of
clinical practice guidelines in designing or
improving processes.
 Standard LD.5.20
When clinical practice guidelines
are used, the leaders identify
criteria for their selection and
implementation.
Rationale for LD.5.20
Selecting and implementing clinical
practice guidelines that are appropriate to the
hospital are critical. The leaders set criteria to
guide the selection and implementation of
clinical practice guidelines that are consistent
with the hospitals mission and priorities.
The leaders also consider the steps and
changes or variations needed to encourage use,
dissemination, and implementation of chosen
guidelines throughout the hospital. This includes
staff communication, training, implementation,
 Feedback, and evaluation.
Elements of Performance for LD.5.20
1. When guidelines are used, the leaders
have identified criteria to guide the selection
and implementation of guidelines.
2. The hospital manages, evaluates, and
learns from variation.
 Standard LD.5.30
Appropriate leaders, practitioners, and
health care professionals in the hospital
review and approve clinical practice
guidelines selected for implementation.
Rationale for LD.5.30
To be successfully implemented, clinical
practice guidelines should be reviewed,
revised, or
adapted by the providers using them and
approved by the hospitals leaders.
Element of Performance for LD.5.30
1. Appropriate hospital leaders have
reviewed and approved the clinical
practice guidelines selected for use.
 Standard LD.5.40

The leaders evaluate the

outcomes related to use of clinical
practice guidelines and determine
steps to improve processes
 Rationale for LD.5.40
To fully benefit from the use of clinical
practice guidelines, the outcomes of patients
treated using clinical practice guidelines are
evaluated, and refinements are made to how
the guidelines are used, if necessary.
 Element of Performance for LD.5.40
Clinical practice guidelines are monitored and
reviewed for effectiveness and are modified
as necessary
Frequently Asked Questions
What are guidelines?
 a. Recommendations for the performance or
exclusion of specific procedures or services
derived through a rigorous methodological
approach that includes the following:
1. Determination of appropriate criteria, such as
effectiveness, efficacy, population benefit, or patient
satisfaction; and
2. Literature review to determine the strength of the
evidence (based in part on study design) in relation to
these criteria.
b. Guidelines are frequently displayed in the form of
an algorithm. An algorithm is a set of rules for
solving a problem in a finite number of steps.
Typically, a clinical algorithm diagrams a guideline
into a step-by-step decision-tree.
What are the main characteristics
of a high-quality Clinical Practice
Guideline
Characteristics of a good guideline include:
Validity - Correctly interpreting available
evidence, so that when followed, valid
guidelines lead to improvements in health.
Reproducibility - Given the same evidence
another guideline group produces similar
recommendations.
Reliability - Given the same clinical
circumstances another health professional
applies them similarly.
Clinical Applicability - Target population is
defined in accordance with scientific evidence.
Clinical Flexibility - Guidelines identify
exceptions and indicate how patient preferences
are to be incorporated in decision making.
 Cost effectiveness - Guidelines lead to
improvements in health at acceptable costs.
Clarity - Guidelines use precise definitions,
unambiguous language, and user-friendly
formats.
Multidisciplinary Process - All key disciplines and
interests (including patients) contribute to
guideline development.
Scheduled Review - Guidelines state when and
how they are to be reviewed.
Documentation - Guidelines record participants,
assumptions, and methods; and link
recommendations to available evidence.
What is a clinical algorithm?
 Typically, a clinical algorithm diagrams a
guideline into a step-by-step decision-tree.
What is the reason for putting the
guideline into an algorithm?
 The algorithmic format allows clinicians to
follow a linear approach to critical clinical
information needed at the major decision points
in the disease management process and
stepwise evaluation and management
strategies that include the following:
Ordered sequence of steps of care
Required observations to be made
Decisions to be considered
Actions to be taken
It is recognized, however, that clinical practice often
requires a nonlinear approach and must always
reflect the unique clinical issues in an individual
patient-clinician situation.
Do clinical algorithms limit
clinical thinking?
 On the contrary, it may be argued
that using a specific approach to solving
a clinical problem is essential to proper
clinical decision making and may increase
the clinician's ability to recognize unusual
problems.
What are Clinical Pathways?
 Clinical Pathways are clinical
management plans that organize,
sequence, and specify timing for the major
patient care activities and interventions of
the entire interdisciplinary team for a
particular diagnosis or procedure.
Clinical pathways define key processes
and events in the day-to-day management
of care.
 They differ from guidelines, by focusing on
the quality and efficiency of care after
decisions have already been made to
perform the procedure or service.
They are almost always locally developed
based upon a broader guideline and may
be included as a part of the clinical record.
Variance from the pathway along with
causes of variance should be
documented.
Where did the guidelines
come from?
 Clinical practice guidelines initially
evolved in response to studies
demonstrating significant variations in risk-
adjusted practice patterns and costs.
Researchers hypothesized that
establishing criteria for the appropriate use
of procedures and services might
decrease inappropriate utilization and
improve patient outcomes.
 Professional societies, health care
policy groups, non-profit disease-oriented
organizations, and government-appointed
panels were among those who responded
by publishing position papers, efficacy
reports, practice policies, and other forms
of advice to practitioners.
While definitive evidence is not yet
available, these clinical practice guidelines
appear to be having an appreciable impact
on medical care.
 How can I be sure that a
clinical guideline is based on
scientific evidence?
 The literature search is followed by
critical analysis of the literature, primarily
by the clinical experts.
To promote an evidence-type approach,
the quality of evidence is rated using a
hierarchical rating scheme.
The value of a hierarchical rating scheme
is that it provides a systematic means for
evaluating the scientific basis for health
care service.
 ADJUSTING FOR
SEVERITY/COMPLEXITY OF
ILLNESS
 Definitions
Severity of Illness" is the degree of risk
of immediate death or permanent loss of
function due to a disease.
Clinical findings are used to assign a
severity rating, ranging from no risk (0) to
death (5), depending on the system.
 A "Severity of Illness" System is a
computerized measurement which adjusts
ICD-9-CM diagnosis codes and/or DRG
designation for hospitalized patients based
on the severity or extent of the illness
treated.
"Complexity of Illness" is the designation
given to subclasses of illness, based on
complications and co-morbidities, in the
DRG Refinements project undertaken by
HCFA (now CMS) and Yale University.
 Goal
The goal of all severity of illness or
complexity of illness systems is to group
patients into homogeneous categories that
reflect the extent or seriousness of the
disease process.
 Examples of Available
Severity/Complexity of Illness Systems

Acuity Index Method (AIM),

distributed by IAMETER, Inc.
(www.iameter.com)
Severity ratings are based on a full year of
discharge data for hospitals and procedure
data for hospital outpatient surgical
services.
APACHE (Acute Physiology and Chronic
Health Evaluation),
distributed by Apache Medical Systems,
Inc. (www.apache-msi.com)
This system provides different severity-
adjusted software to trend patients and
predict need for critical care, "heart care,"
and acute care, and analyze clinical and
financial outcomes.
3M APR-DRGs
(All Patient RefinedDiagnosis Related
Groups),
a combination of the Yale R-DRGs (DRG
Refinements) and another then HCFA/3M
project called AP-DRGs (All Patient DRGs),
which modified DRGs for non-Medicare patients.
Distributed by HIS Systems,
3M APR-DRGs adjusts patient data for
severity of illness and risk of mortality.
(www.3m.com/market/healthcare/his/us/product,
 Complexity of Illness Subcategories
for APR-DRGs:
Minor
Moderate
Major
Extreme
Atlas
distributed by Cardinal Health (originally
"MedisGroups," by MediQual Systems,
Inc.), uses concurrent clinical findings and
patient encounter data with severity-
adjustment algorithms to track patients
through the continuum of care.
(www.mediqual.com/products/atlasoutcomes.as
p)