HCQM Certification Core Body of Knowledge

Module 1 – Quality Improvement, Quality Management, and Quality Assurance

Author: Richard F. Kaine, MD
Updated: ABQAURP

At the conclusion of this module, attendees should be able to:

 Name the major theorists and explain how their theories have been applied to Quality

Assurance, Quality Management, Quality Improvement, Continuous Quality Improvement,

and Total Quality Management

 Explore the purpose and programs of Risk Management

 Identify tools and processes used to determine quality of care issues and/or assure quality

processes in a variety of health care environments

 Describe the role of the PSRO (Professional Standards Review Organization), the PRO (Peer

Review Organization), and the QIO (Quality Improvement Organization) in assuring quality

health care

 Discuss the use of peer review in assuring quality of care in a variety of settings

AUTHOR NOTE

Richard F. Kaine, MD, retired Quality Consultant.

Members of the CME Committee, Planners, and Faculty have disclosed to ABQAURP any

relevant financial relationships. No relevant financial relationships or conflicts of interest exist

in regard to the content of this online activity.

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Table of Contents
QUALITY DEFINED ........................................................................................................................... 4

EVOLUTION OF QUALITY ................................................................................................................. 4

John W. Williamson, MD ............................................................................................................. 5

Avedis Donabedian, MD ............................................................................................................. 6

Walter Shewhart ......................................................................................................................... 6

W. Edwards Deming, MD ............................................................................................................ 6

Joseph M. Juran .......................................................................................................................... 9

Philip B. Crosby ......................................................................................................................... 10

QUALITY MANAGEMENT .............................................................................................................. 10

Quality Focuses ......................................................................................................................... 10

Quality Assurance ..................................................................................................................... 11

Quality Improvement/Performance Improvement .................................................................. 12

Continuous Quality Improvement ............................................................................................ 13

Total Quality Management ....................................................................................................... 13

Credentialing ............................................................................................................................. 15

RISK MANAGEMENT...................................................................................................................... 15

UTILIZATION REVIEW .................................................................................................................... 16

Medical Records........................................................................................................................ 16

Infection Control ....................................................................................................................... 17

Structured Process .................................................................................................................... 17

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 Off-Track Conclusions ............................................................................................................... 18

Outcomes .................................................................................................................................. 18

Outcome Measurement Framework ........................................................................................ 20

Comparison Tools / Statistical Analyses ................................................................................... 21

PEER REVIEW................................................................................................................................. 22

QUALITY OVERSIGHT..................................................................................................................... 25

Centers for Medicare & Medicaid Services (CMS) .................................................................... 25

Pay for Performance ................................................................................................................. 26

Managed Care Quality Monitoring ........................................................................................... 27

Quality Improvement System for Managed Care (QISMC) ...................................................... 28

Summary ................................................................................................................................... 28

REFERENCES .................................................................................................................................. 30

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 QUALITY DEFINED

How is Quality defined?

 No errors

 Degree of Excellence or Merit

 Value + Cost Effectiveness

 Doing the Right Thing at the Right Time and Doing it Well

 Moving from prevailing practices to best practices

 Expectations: effectiveness, efficiency (costs), positive outcomes

 Meeting the Customer’s Expectations

 Exceeding Customer’s Expectations

All of the theories about Quality Management have a basic common thread: examine

the processes leading to the delivery of care, the outcomes expected from the care, and the

degree to which the expected outcomes are reached. Each of the leaders considered here has

added a specific refinement to the basic approach.

Abraham Flexner Walter Shewhart

E. A. Codman W. Edwards Deming
John W. Williamson Joseph M. Juran
Avedis Donabedian Philip B. Crosby

EVOLUTION OF QUALITY

The approaches to quality in medicine have evolved from Abraham Flexner’s initial idea

that quality should be measured. From the very beginning of quality measurement in medicine,

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there has been awareness that the end results (outcomes) are critical.

Ernest Amory (E.A.) Codman, MD, was a pioneering Boston surgeon in the early 1900s

with an interest in health care quality. Dr. Codman helped lead the founding of the American

College of Surgeons and its Hospital Standardization Program, which eventually became The

Joint Commission (formerly JCAHO). Codman was also a public health pioneer, studying hospital

outcomes to determine how they could be improved. In recent years, The Joint Commission

established the Ernest A. Codman Award for the use of outcomes measures to advance the

quality and safety of patient care.

In 1918, quality theories were evolving and the American College of Surgeons began to

address the fact that patients did not feel comfortable with the concept that ‘the operation was

a success, but the patient died.’

John W. Williamson, MD

Dr. John W. Williamson is a pioneer leader in the field of health care outcomes research

and its implementation; and is a recent recipient of the EA Codman Award (2000). Abraham

Flexner, Codman, and Williamson all proposed that the best means to assess the quality of care

is through the measurement of outcomes. There have since been swings between the

measurement of outcomes as a method of assessing quality and measuring the processes

leading to those outcomes. The current thinking is that there must be a combination of both

these measurements.

Outcome measures help identify (prioritize) areas for which measuring and analyzing

the processes are likely to lead to improved outcomes. When the outcomes do not meet the

expectations, it is appropriate to measure the process producing the outcome to improve

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possibly substandard performance.

Avedis Donabedian, MD

Dr. Avedis Donabedian has been recognized as the individual who brought modern

quality assurance techniques to modern medicine. As with others working in the field of quality,

Donabedian has emphasized structure, process, and outcome as the focal points for analysis of

medical care quality.

Walter Shewhart

Walter Shewhart was an American

physicist, engineer, and statistician, but offers a

useful approach for analyzing medical quality. His

main work was in the area of statistical quality

control. Deming named Shewhart’s cycle the “Plan-Do-Check-Act” approach to improving care.

This P-D-C-A Cycle is heavily emphasized in medicine because it embodies the principles of the

scientific method. The familiarity of this approach makes it comfortable for health care

professionals to embrace.

W. Edwards Deming, MD

Deming was also a statistician. He realized the importance of having accurate and

meaningful information to improve quality. He introduced statistical processes to the industrial

quality process. As he continued to work in the field, he expanded his concepts and proposed

fourteen points for management:

1) Create constancy of purpose toward improvement of product and service, with the

aim to become competitive, stay in business and provide jobs.

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 2) Adopt the new philosophy. Management must take on leadership for change.

3) Cease dependence on inspection to achieve quality. Build quality into the product in

the first place.

4) Move toward a single supplier for any one item, creating a long-term relationship of

loyalty and trust.

5) Improve constantly and forever the system of production and service.

6) Institute training on the job.

7) Institute leadership. Supervision should aim to help people do a better job.

8) Drive out fear so that everyone may work effectively.

9) Break down barriers between departments.

10) Eliminate slogans, exhortations, and targets for the work force.

11) Recognize that the cause of low quality and low productivity belongs to the system,

and thus lies beyond the power of the work force.

a) Eliminate quotas and substitute leadership.

b) Eliminate management by objective. Substitute leadership.

12) Remove barriers to pride-of-workmanship.

13) Institute a vigorous program of education and self-improvement.

14) Put everyone to work to accomplish transformation.

Coupled with these, Deming identified seven “deadly diseases” which interfere with the

achievement of continuous improvement:

1) Lack of constancy of purpose

2) Emphasis on short-term profits

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 3) Evaluation of performance, merit rating or annual review

4) Mobility of management; i.e., job-hopping

5) Management by use of “visible figures”, with no consideration of unknowns or

unknowables

6) Excessive medical costs

7) Excessive liability costs

Deming believed, from experience and statistical analysis, that the system has far more

impact on quality than do the individuals within the system. The aforementioned twenty-one

items are his guidelines for improving quality throughout any organization.

Deming was a major proponent of the use of statistical quality control. He has cited two

possible reasons for undesirable performance. The first, which he called “Special Cause,” results

from an unpredicted action on a system. An example would be an increase in the length of a

patient’s stay due to injuries sustained when the hospital’s roof collapses. “Blips” on a control

chart characterize these special causes in the system. The majority of variations in outcomes

from a system are a result of “Common Cause” events, i.e., day-to-day variations within a

system.
Statistical Quality Control
Statistical analysis helps to  Structured approach to managing quality
 SPC (Statistical Process Control) charts
keep the quality process focused on o Display data over time
o Picture trends over time
actual, rather than just apparent, o Display upper and lower statistical limits

opportunities for improvement.

When the proper statistical method is used to monitor improvement data, the resulting

information gives a clearer picture of the actual effectiveness of an improvement. Different

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statistical tools are available to adequately analyze large and small samples. Selecting the

proper tool allows the organization to meaningfully interpret most data.

Deming noted that statistical control charts could be used to differentiate between

special cause and common cause. These are run-charts (line graphs) upon which the upper and

lower standard deviation lines are drawn. Variations occurring between the upper and lower

standard deviation lines are attributed to common cause. Special causes usually result in a

point outside the control limits, while common cause creates “zigzagging” of the measurement

within the standard deviation limits.

Deming observed that by manipulating the systems used to “produce the product;” the

distance between the standard deviation lines could be narrowed. Therefore, a more reliable,

homogeneous, reproducible process is obtained. He emphasized that special causes frequently

consume the most resources to correct, but have the least impact on improving the system.

However, addressing the common causes will produce the greatest impact on patient

outcomes.

Joseph M. Juran

Juran introduced the concept of Total Quality Control. His theory is based on a trilogy of

quality planning, quality control, and quality improvement. Juran made the observation that,

while many factors influence a system, only a vital few factors will significantly change the

system.

This is a complementary idea to special cause and common cause. The vital few factors

would be elements of common cause with the most influence on the system. Juran’s theory of

Total Quality Control emphasizes the need for the entire organization to participate. To assure

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that there is both adequate consideration to deploy improvement resources and continuous

follow-up of the results, Juran proposed a Council to oversee the entire quality process.

Philip B. Crosby

Crosby added the financial consequences of quality performance to these same basic

quality improvement principles. By calculating the amount of money spent on mistakes and

subtracting what it would have cost to do things right the first time, Crosby proposed that an

organization can determine a “Cost of Non-Conformance.” His concept helps quantify the

financial benefits of using the quality processes. The cost of non-conformance’s impact creates

a financial incentive for investing in the quality process. The cost of nonconformance highlights

the savings generated by “doing things right the first time.”

QUALITY MANAGEMENT

Quality Management (QM) is a broader conceptualization of the approaches to

improving quality. The term serves as an umbrella that covers the entire field of quality review.

There are nine aspects usually considered in the process for improving quality. Each of these

key elements represents a unique focus on the quality of care. It is helpful to understand the

contribution each approach makes.

Quality Management
QA - Quality Assurance Risk Management
QI - Quality Improvement Utilization Review
CQI - Continuous Quality Improvement Medical Records
TQM - Total Quality Management Infection Control

Quality Focuses

Quality Assurance addresses primarily negative outcomes (i.e., sentinel events). It seeks

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opportunities for improvement by monitoring bad events. QA has a long history of being

associated with punishment of peers.

Quality Improvement or Performance Improvement seeks opportunities to improve

care by improving upon outcomes that are currently considered satisfactory, i.e., getting better

at what is already done well.

Continuous Quality Improvement builds on previous improvements and uses a

systematic process, including data analysis, to continuously enhance performance.

Total Quality Management encompasses the first three approaches and adds the

dimension of organizational improvement and a focus on customer desires.

Quality Assurance

It is impossible to analyze every aspect of care continuously. Therefore, various

approaches exist for identifying opportunities for improvement. The oldest is Quality Assurance

(QA). QA has been the basic approach to improving quality since Flexner’s introduction of

quality measurement into medicine. QA focuses on negative events to identify opportunities for

improvement. The appeal of QA is that it

focuses attention on events that we prefer Sentinel Events

 Definition
never occur. The weakness of QA is that o Unanticipated Death
o Unrelated Major Loss of Function
negative events only affect a small portion of o Inpatient Suicide
o Actual Rape
patients. If QA is the only approach, there is a o Infant Abduction
o Hemolytic Transfusion Reaction
risk that care will not be improved for the o Wrong Site Surgery

majority of patients.  Consider Near Miss Events

There is a sub-category of negative events known as sentinel events. These represent

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major negative outcomes (e.g., unanticipated death or long-term loss of function) for which

even a single occurrence requires an immediate in-depth analysis and corrective actions so-as-

to promptly protect against a reoccurrence. Both the Federal Government and The Joint

Commission (TJC) emphasize the importance of immediate, in-depth analysis of serious

negative events. These events provide a sentinel notification to the organization of possible

weaknesses in the care system that is larger in scope than an individual’s incompetence.

Therefore, these circumstances may represent major vulnerabilities for reoccurrences.

The preferred technique for analyzing a sentinel event is a Root Cause Analysis (RCA).

The RCA seeks to determine both the proximal cause of an event (the immediate cause) and the

root cause (underlying cause). A truly in-depth analysis includes cultural issues leading to the

event, e.g., the prevailing attitude that the doctors are always right, or the idea that if people

know how to do things right, they will always do things right. These frequently held

assumptions often underlie a negative event and must be addressed to actually prevent a

reoccurrence. Cultural factors are of such importance that an RCA is considered incomplete

when it does not include an assessment of the culture.

Quality Improvement/Performance Improvement

The Quality Improvement (QI) (frequently called Performance Improvement [PI])

approach seeks opportunities for improvement. It is not only limited to problem areas, but also

addresses areas with good outcomes in the hopes of making them better. Unlike QA, which

focuses solely on negative outcomes, QI deals with both negative and positive outcomes.

For example, the traditional cholecystectomy was improved by the introduction of the

laparoscopic cholecystectomy. The QA process only reviewed cholecystectomies if they

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resulted in negative outcomes such as retained stones, infections, or persistent pain. The QI

process looks at this high-volume, successful procedure for improvement opportunities. QI is

more likely to focus on processes and systems than on individuals, because improvements for

good performance are most often achieved through improved systems.

Continuous Quality Improvement

Continuous Quality Improvement (CQI) revisits already improved areas and focuses on a

continuous cycle of enhanced achievement. As with QI, CQI focuses more on processes than on

individuals. This method of improvement analyzes updated data and information to spot new

opportunities to improve processes that have already been addressed.

An example of CQI is the reduction in hospital lengths-of-stay at the introduction of

laparoscopic cholecystectomy from five days for a traditional cholecystectomy to a three-day

stay and ultimately to an overnight stay or outpatient procedure. This illustrates an

improvement from the traditional cholecystectomy by using a laparoscope to remove a gall

bladder and, in turn, decrease length-of-stay.

Total Quality Management

Total Quality Management (TQM) represents an aggregation of the basic principles of QI

and CQI. TQM uses a systems-based approach to focus on the organization and the need for

organizational support. TQM is usually driven by customer desires for improvements to current

processes and outcomes.

For example, laparoscopic cholecystectomy has produced a dramatic improvement in

patient care for gall bladder removal. However, in keeping with patients’ desires, lithotripsy of

gallstones would completely eliminate the need for surgery.

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 TQM should be regarded as the culmination of the quality process rather than an

individual unique aspect of the quality process.

Lean, Six Sigma, and Lean Six Sigma Approaches to Quality

LEAN is an approach to quality improvement that originated in Japan. It began with a

focus on production systems, i.e., it is grounded in the analysis of the actual processes that

produce the outcome. Like quality improvement, it is based upon data and continuous

improvements over time. The improvements are achieved by improving process flow and

eliminating unnecessary steps or steps that do not “add value”, i.e., producing a Lean process.

The findings and improvements of lean target improved processes, which are integrated into

daily work.

SIX SIGMA is a quality approach that uses data-driven information to “eliminate

defects,” i.e., achieve a theoretical “six standard deviations” between the mean and the nearest

specification limit. To achieve six sigma performance, a process must not produce more than

3.4 defects per million opportunities. A defect is not meeting the customer specifications. (Like

total quality management, six sigma is customer-driven.) The objectives of six sigma are not

only to improve process flow, but also to reduce process variation. Therefore, six sigma

expands the focus beyond lean process flow to include process management.

There have been proponents for the use of lean and others for the use of six sigma as

the exclusive tools to improve quality. A combination of the approaches into LEAN SIX SIGMA is

providing an effective tool for solving a problem. It consists of five basic phases: Define,

Measure, Analyze, Improve, and Control (aka follow-up). This method is also known as DMAIC

(pronounced “duh-may-ik”).

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Credentialing

Credentialing is a key component of QM. The credentialing process assures that the

correct individual (with the correct skills, the correct knowledge, and the correct performance)

is put in the correct position.

With successful credentialing as a cornerstone, QA and Peer Review become less

important in the quality process. When only qualified, currently competent individuals are

involved; variances in outcomes may be reasonably investigated with the primary focus being

on the environment and systems in which qualified people work. The quality approach has

more latitude to be supportive rather than punitive if the personnel are competent. Note that

qualified individuals do have lapses in judgment or technical performance. The system

approach seeks to introduce safeguards that prevent lapses from resulting in negative results.

This does not eliminate the need to monitor individual performance, since people can

become impaired at any point in time. Violations of quality care attributable to a specific

individual can still trigger a termination of privileges. However, the major focus would be on

creating strong systems that help prevent failure even when a provider is having a bad day.

RISK MANAGEMENT

Risk Management (RM) relates to the quality process as it focuses on preventing

monetary loss by eliminating negative outcomes. RM issues include insurance, patient

satisfaction, and legal issues. By analyzing areas in which an organization or provider may lose

money, opportunities for improvement can be identified. RM frequently focuses on improving

the documentation of care as a means to protect the providers if a question arises regarding

services provided.

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 Risk management uses the quality processes to determine what can be done proactively

to prevent a reoccurrence of situations that produce risks. As with others interested in quality,

risk managers seek to eliminate chronic or recurring problems in order to minimize future risks.

A strong linkage between RM and QM can help focus the organization’s resources on improving

care. A common database of information and use of medical record analysis is very helpful.

RM deals with loss prevention on a day-to-day basis. Risk managers prefer to use a

proactive approach so as to avoid negative situations. Positive outcomes, satisfied patients, and

adherence to regulations all decrease loss potential for the providers and the facility.

When potential losses arise as a result of negative care outcomes or dissatisfaction with

the service provided, risk managers use an individualized approach aimed at reducing monetary

losses.

UTILIZATION REVIEW

Utilization Review (UR) is a formal review of the consumption of all resources used in

delivering care to a patient. Traditionally UR has focused on the length of stay or the

appropriateness of performing a procedure. Currently UR also includes analyses of specific

resources such as the choice of medication or the selection of an appropriate implant. A

utilization review may be performed on a prospective, concurrent, or retrospective basis. The

main focus is on improving already successful care by reducing the resources used to achieve

the same results.

Medical Records

In the quality process, medical records are used as a primary source of information. To

reliably interpret the medical record, it is important to understand the accuracy of the record.

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Four types of records exist: good records of good care, bad records of good care, good records

of bad care, and bad records of bad care. Often the record is interpreted without validating

which of the four types of records you are reviewing. When data is not recorded in the medical

record, there is generally an assumption made as to why it is missing. When information is in

the record, it is usually presumed to be a reliable record of what happened. However, for the

medical record to provide the greatest value to the quality process, the individual responsible

for creating the record must be contacted to clarify the actual status. Records are useful in the

process only when they are clearly understood.

Infection Control

Infection Control (IC) is a sub-set of complication

rates that also involves analysis of the transmission of Infection Control

 Staff to Patient
 Patient to Patient
illness to providers. Infection rates for patient populations
 Patient to Staff
 Staff to Staff
or for provider populations frequently indicate system
 OSHA IS YOUR FRIEND!
weaknesses that can lead to improvement opportunities.

The quality process and infection control focus on outcomes. Traditional infection

control has centered on individual case analysis and data collection. The current expectation is

that the information will be aggregated and used to determine ways of reducing the risk of

future infections as well. When analyzing IC data and information, the most important question

to answer is, “How will we reduce the occurrence or spread of infections for patients, staff, or

visitors?”

Structured Process

Health care organizations commit to a quality process by endorsing a written plan for

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improving quality. The Quality Plan provides a structured process for achieving the identified

set of goals and objectives that pertain to the continuing quality improvement process. The

overall goal of this Plan is to achieve organization-wide value and cost-effectiveness from the

quality process. The Plan describes the processes to use that can coordinate the functions of all

departments and divisions of the health care entity or managed care company.

A Quality Plan should be customized annually to delineate specific quality improvement

projects and processes to be ongoing and monitored throughout the year, e.g., using an

appendix that lists the current year’s goals. Each project described within this plan will be

implemented according to specified guidelines. The projects should be aimed at risk reduction

and continuous improvement of care.

Off-Track Conclusions

When you hear words like “ought to, should, could, or would,” think “so what?” These

terms are usually indications that the process may be getting off-track. They often divert

attention from the actual issues, because they address expected performance rather than the

reality of the situation.

A well-planned improvement should reduce the probability of a sub-optimal outcome

reoccurring. Conditional phrases tend not to assure the reliability of the system. For example,

the assumption that a doctor “should know the right dosage” does not assure that the doctor’s

thought processes will be as reliable at 3 A.M. as they are at 3 P.M.

Outcomes

In reviewing the various quality approaches, it is clear that they share outcome

measurements as a key process and outcome improvements as the goal. Even when using

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“process-focused models” (lean and six sigma) as the approach to improving quality, the

modified processes are manipulated to improve ultimate health outcomes or optimize

resource-consumption outcomes. However, it is noteworthy that outcomes can at times be

difficult to specify, e.g., an individual’s health status or the health of an entire population. It is

critical to recognize the importance of clear definitions for the measures used. One must be

careful to recognize that some outcome measurement may not be totally accurate, e.g.

population-health can be vague, while immunization rates can be more specific. Broad outcome

measures therefore have limitations.

It is important to acknowledge and understand the complaint of many physicians that

outcomes data measures ‘all aspects of the processes used to achieve the outcome’ and

therefore may not necessarily be statistically valid for the individual physicians, i.e., may not be

appropriate as a peer review tool. This complaint points out the need to carefully analyze the

processes that lead to the outcome measured before drawing specific conclusions or taking

corrective actions. For example, when analyzing a high infection rate or a high readmission rate,

one should use multiple tools, e.g. cause-and-effect diagrams (fish-bone diagrams), flow charts,

root-cause analysis, and failure-mode analysis to fully understand how the processes produce

the outcomes-data. Clearly, the analysis of “causation” may lead to the investigation of an

“individual’s” performance thus requiring peer review and peer-centered action.

While outcomes measures may have weaknesses, they are currently being collected and

published nationwide. The nature of the outcomes is not just health-status related. Important

outcomes include customer satisfaction and perceptions. Even when performance is

“adequate” or even “excellent,” it may not meet the “customer’s” expectation. Note: Current

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quality terminology includes both internal (staff) and external (patient and family) customers'

perceptions in the assessment of satisfaction.

The Centers for Medicare & Medicaid Services (CMS) website publicly reports the results

of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

HCAHPS is the first national, standardized, publicly-reported survey of patients' perspectives of

hospital care. The CMS website reporting HCAHPS states that reporting the data provides an

incentive to create improvements in quality of care in hospitals and enhances accountability.

Outcome Measurement Framework

Consider direct causality: If a certain treatment approach is applied for a designated

amount of time, will the baseline improve? Drug trials were the first outcome studies, with

white blood cells measured before and after a course of antibiotics. When implementing any

improvement approach, it is important to know if it actually achieves the intended

improvement. As with the introduction of case management or any other complex approach to

improving patient care, it is necessary to demonstrate the positive effect.

To adequately determine the impact of any process change, it is critical to agree on the

information to be collected. As an example, when analyzing the advantages of a specific case

management strategy on the length of stay, it is necessary to document the exact tactics used.

This permits understanding of those measures that are

Effective PI Process
successful and those that are not helpful in achieving the  Find an Opportunity to
Improve
intended improvement goals.  Assess the Opportunity
 Act on Opportunity
Consider efficiency: Outcome studies are
 Measure Results

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important in analyzing effectiveness. When approaching measurement, it is also important to

gain the maximum information with the minimum effort. For example, if one wants to measure

if a provider or case manager is maximizing positive outcomes while minimizing costs, they can

gather data from multiple sources. Experience has shown that audits done by single reviewers

are the least reliable. Experience also demonstrates that self-report surveys are vulnerable to

inaccuracy. For efficiency and reliability, computer-generated outcome reports are preferable,

since computer data is based on predetermined, measurable criteria rather than “impressions”

or “opinions,” e.g. measures such as cost of care, length of stay, time in surgery, complication

rate, infection rate, etc.

Comparison Tools / Statistical Analyses

Comparison is a core element in the interpretation of data. Whether or not an

organization chooses to compare itself with others; the public, payers, and competitors have

access to the data and use it to choose providers. It is best for those who are being measured to

know what others are seeing and believing about the organization’s performance.

Comparison is best accomplished using various statistical methods. In health care,

statistical tools and controls are extremely helpful in confirming the impact of changing a

process upon the care outcome.

Some use the pre-test/post-test model of applying a treatment and measuring the

results or a time series model (Campbell and Stanley, 1963). The following steps provide a

simple model:

 To assure data integrity, establish definitions, procedures, and scripts to be

followed so that there is reproducibility among data collection processes.

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  Get baseline or pre-test measurement (T1).

 Apply the treatment for a pre-selected amount of time (X).

 Measure again (T2).

 Determine statistical significance between T1 and T2.

PEER REVIEW

The term peer review has multiple meanings within the quality process. The first is that

used in the statutes, i.e., evaluation of the total health care provided. This definition includes all

forms of quality oversight and specifies protection from discoverability, i.e., peer review

statutes and protection.

The second definition specifies that Define Peer Review

 What is it?
an individual with similar training and o Level I – Chart Screening
o Level II – Patterns and Trends
expertise does the review of another o Level III – Peer Interventions
 Who does it?
individual’s professional judgment and o Screeners with Peer Criteria
o Data Analyst/Peers
technical performance. Unfortunately, there o Peers

is no clear definition of similar. The broadest

interpretation of similar means an individual with like education and professional degree. The

more narrow definition of peer is an individual with similar specialty or sub-specialty training as

that of the individual being reviewed. Although not required, a professional with similar

privileges is the preferred peer to use when punitive action is being considered against a

provider.

The third definition of peer review encompasses the entire process used to oversee

performance. It includes every step of review system from the initial setting of indicators

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through the review of a decision to act to improve quality.

Given the various scopes of each definition, it is important for each organization to

clearly define what it means by Peer Review. This definition becomes part of the organization’s

roadmap for improving quality.

When organizing the quality process related to reviews by like professionals, it is

important to maintain an efficient and effective process. Make the contributions of peers clear

by defining each of the following three levels:

1) Peers identify the criteria to be used in judging care.

2) Peers review information to confirm variances or to assess patterns in addition to

specific variances.

3) Peers are included in the review process when the analysis of care suggests a

significant cause of a negative outcome is directly related to an individual’s

judgment and/or technical performance.

When one peer is asked to review the work of another, the review should be timely, e.g.

performed within 30 days and completed by 90 days after the issue is identified. The results of

the peer’s review should be reported through the correct chain-of-command as specified by the

organization’s plan for improving quality.

QUALITY TIMELINE

1972 – 1982 Peer Review Organization (PRO):

Created as part of Title XI of the Social Security Amendments Act of 1972, Professional
Standards Review Organizations (PSROs) were physician-controlled nonprofit
organizations that contracted with HCFA (now CMS) to provide for the review of
hospital inpatient resource utilization, quality of care, and medical necessity. PSROs
were replaced with Peer Review Organizations (PROs), as a result of the Tax Equity and
Fiscal Responsibility Act (TEFRA) of 1982 to review quality of care and appropriateness
of hospital admissions, readmissions and discharges for Medicare and Medicaid.

Core Body of Knowledge – Module 1 – QI, QM, QA Page 23 of 31

 1993 Quality Assurance Reform Initiative (QARI):
QARI was unveiled in 1993 to assist states in the development of continuous quality
improvement systems, internal and external quality assurance programs, and focused
clinical studies. HCFA introduced the Quality Assurance Reform Initiative (QARI) in 1993 to
guide state Medicaid agencies as they developed methods and standards for monitoring the
quality of care provided to Medicaid Managed Care (MMC) enrollees. QARI provides a
general approach for Medicaid agencies to follow, but does not offer specific tools or
methodologies for agencies to use.

1996 Quality Improvement System for Managed Care (QISMC):

The Centers for Medicaid & Medicare Services (CMS) was actively promoting a quality
management agenda for states. The federal government developed the Quality
Improvement System for Managed Care (QISMC) program in 1996 as a guide to quality
management oversight for federal and state health care purchasers. QISMC is required of
health plans participating in Medicare, and it served as a voluntary guide for state Medicaid
programs.

1997 Balanced Budget Act (BBA):

The Balanced Budget Act (BBA) of 1997 included new provisions for Quality Assessment and
Performance Improvement. It included a comprehensive revision of federal statutes
governing Medicaid managed care.

2002 Quality Improvement Organization (QIO):

In 2002, PROs become Quality Improvement Organizations (QIOs), which better describe
their proactive role in improving health care.

CMS issued a final rule in 2002 to implement BBA provisions that defined how quality
measurement and performance improvement programs should be applied to MMC. These
provisions espoused and updated the approach outlined in QISMC and specified that
Medicaid programs develop and implement a comprehensive quality assessment and
improvement process in both clinical and nonclinical areas and that states conduct an annual
external quality review of MMC organizations. Thus, through these and other activities,
federal policymakers have promoted the active involvement of state agencies in plans’
quality assurance and improvement activities, and a value-based purchasing agenda.

2006 Physician Quality Reporting Initiative (PQRI):

The Tax Relief and Health Care Act of 2006 (TRHCA) authorized implementation of a
physician quality reporting system that establishes a financial incentive for eligible
professionals who participate in a voluntary quality reporting program. Has since been
renamed to the Physician Quality Reporting System (PQRS) and is a "pay for performance"
program which rewards providers financially for reporting health care quality data to CMS.

Core Body of Knowledge – Module 1 – QI, QM, QA Page 24 of 31

 2008 Medicare Improvements for Patients and Providers Act
The Medicare Improvements for Patients and Providers Act made PQRS permanent and
increased the incentive payment to 2%. The last year for the PQRS incentive was calendar
year 2014.

2010 Patient Protection and Affordable Care Act

Introduces penalties for providers who do not submit PQRS data. No longer an incentive, but
a requirement. By reporting PQRS quality measures, providers can quantify how often they
are meeting a particular quality metric and can assess the quality of care they are providing
to their patients, helping to ensure that patients get the right care at the right time.

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/PQRS/Downloads/PQRS_OverviewFactSheet_2013_08_06.pdf

QUALITY OVERSIGHT

Centers for Medicare & Medicaid Services (CMS)

CMS administers the PRO/QIO program, which monitors the quality of care for Medicare

and Medicaid beneficiaries. There are two types of QIOs in support of the QIO Program:

Beneficiary and Family Centered Care (BFCC-QIOs) and Quality Innovation Network (QIN-QIOs).

BFCC-QIOs manage beneficiary complaints and quality of care reviews to ensure consistency in

the review process while taking into consideration local factors important to beneficiaries and

their families. Two BFCC-QIOs serve all 50 states and three territories of the U.S., they are

grouped into ten regions. There are 14 QIN-QIOs bringing together Medicare beneficiaries,

providers, and communities in data-driven initiatives to increase patient safety, make

communities healthier, better coordinate post-hospital care, and improve clinical quality. Each

maintains a staff of multi-disciplinary experts in medicine, nursing, quality improvement, health

information management, statistical analysis, computer operations, and communications.

QIOs are an important part of current quality evaluations related to Medicare patients.

Core Body of Knowledge – Module 1 – QI, QM, QA Page 25 of 31

 By law, the mission of the QIO Program is to improve the effectiveness, efficiency,

economy, and quality of services delivered to Medicare beneficiaries. Based on this

statutory charge, and CMS' Program experience, CMS identifies the core functions of the

QIO Program as:

 Improving quality of care for beneficiaries;

 Protecting the integrity of the Medicare Trust Fund by ensuring that Medicare

pays only for services and goods that are reasonable and necessary and that are

provided in the most appropriate setting; and

 Protecting beneficiaries by expeditiously addressing individual complaints, such

as beneficiary complaints; provider-based notice appeals; violations of the

Emergency Medical Treatment and Labor Act (EMTALA); and other related

responsibilities as articulated in QIO-related law.

(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/QualityImprovementOrgs)

Pay-for-Performance

Pay-for-Performance is the term used to describe incentive plans used to encourage

improvement in quality and efficiency. The nature of the incentives and the specific criteria for

earning the incentives are determined by individual health care payer programs. Pay-for-

Performance programs have been implemented by both Medicare and private insurers.

This is described in a quote from the Agency for Healthcare Research and Quality

(AHRQ): “Pay-for-Performance (P4P) programs are designed to offer financial incentives to

physicians and other health care providers to meet defined quality, efficiency, or other targets.”

Core Body of Knowledge – Module 1 – QI, QM, QA Page 26 of 31

 A more comprehensive definition is contained in a quote from Integrated Healthcare

Association (IHA):

Healthcare Pay for Performance (P4P) programs reward hospitals, physician practices

and other providers with both financial and non-financial incentives based on

performance on select measures. These performance measures can cover various

aspects of healthcare delivery: clinical quality and safety, efficiency, patient experience

and health information technology adoption.

P4P hopes to achieve positive change by rewarding providers for the desired achievements.

CMS is using the process nationwide to evaluate the quality and efficiency of hospitals,

providers, and health care plans serving Medicare and Medicaid recipients. Through a phased-

in process, payments to individuals performing in the top ten percent (for CMS designated

indicators) will receive enhanced reimbursement and those in the bottom 10% will receive

diminished reimbursement.

Managed Care Quality Monitoring

Managed Care, HMO, PPO, and Workers’ Compensation Managed Care arrangements

use a variety of quality tools to assess the quality of care. Although direct evaluation of care is a

part of the process, a large dimension of monitoring involves statistical analysis of outcome

data and careful analysis of patient feedback through patient satisfaction surveys and

investigation of patient grievances. Medical directors and case management staff oversee

adherence to critical pathways and level of care guidelines. Evaluation may even include

overseeing/auditing services from non-network practitioners chosen by network patients

themselves to provide out-of-network care. This often depends upon the relationship of the

Core Body of Knowledge – Module 1 – QI, QM, QA Page 27 of 31

plan to the provider, the resources available, and the services provided to the patient.

Quality Improvement System for Managed Care (QISMC)

The QISMC was a CMS program designed to strengthen MCOs' efforts to protect and

improve the health and satisfaction of Medicare and Medicaid enrollees. This quality of care

initiative established a unified oversight system for Medicaid and Medicare managed care. The

ultimate goal of QISMC was to establish objective and measurable standards to improve the

health of Medicare and Medicaid beneficiaries.

The QISMC standards and guidelines are key tools for use by CMS and states in

implementing the quality assurance provisions of the Balanced Budget Act of 1997 (BBA), as

amended by the Balanced Budget Refinement Act of 1999. The QISMC standards and guidelines

are intended to achieve four major goals:

 To clarify the responsibilities of CMS and the states in promoting quality as value-based

purchasers of services for vulnerable populations.

 To promote opportunities for partnership among CMS and the states and other public

and private entities involved in quality improvement efforts.

 To develop a coordinated Medicare and Medicaid quality oversight system that would

reduce duplicate or conflicting efforts, and send a uniform message on quality to

organizations and consumers.

 To make the most effective use of available quality measurement and improvement

tools, while allowing sufficient flexibility to incorporate new developments in the rapidly

advancing state of the art.

Summary

Core Body of Knowledge – Module 1 – QI, QM, QA Page 28 of 31

--- Quality is About Doing the Right Thing Right

--- Monitoring is the Tracking Process

--- Assurance and Improvement Fix Things

--- Follow-Up Assesses Effectiveness

GOOD QUALITY KEEPS EVERYONE HAPPY!!

Core Body of Knowledge – Module 1 – QI, QM, QA Page 29 of 31

 REFERENCES

Bhatia, A.J., Blackstock, S., Nelson, R., Ng, T.S. (2000). Evolution of Quality Review Programs for

Medicare: Quality Assurance to Quality Improvement. Health Care Financing Review;

Volume 22, Number 1:69-74. Retrieved November 19, 2020, from

https://www.cms.gov/Research-Statistics-Data-and-

Systems/Research/HealthCareFinancingReview/downloads/00fallpg69.pdf

Campbell, D.T., Stanley, J. C. (1963). Experimental and Quasi-Experimental Designs for

Research. In Handbook of Research on Teaching. Boston, MA: Houghton Mifflin

Company. Retrieved December 15, 2020, from

https://www.sfu.ca/~palys/Campbell&Stanley-1959-

Exptl&QuasiExptlDesignsForResearch.pdf

Centers for Medicare & Medicaid Services. (2011, July). Advances in Quality: QIO Program

Progress Report. U.S. Department of Health & Human Services. Retrieved November 19,

2020, from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/QualityImprovementOrgs/downloads/QIO_ProgressReport_July2011.pdf

Centers for Medicare & Medicaid Services. (n.d.). Quality Improvement Organizations. U.S.

Department of Health & Human Services. Retrieved November 19, 2020, from

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/QualityImprovementOrgs

go LEAN SIX SIGMA. (n.d.). DMAIC – The 5 Phases of Lean Six Sigma. Retrieved November 19,

2020, from: https://goleansixsigma.com/dmaic-five-basic-phases-of-lean-six-sigma/

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iSix Sigma®. (n.d.). What is Six Sigma? Retrieved November 19, 2020, from:

http://www.isixsigma.com/new-to-six-sigma/getting-started/what-six-sigma/

Landon, B.E., Schneider, E.C., Tobias, C., Epstein, A.M. (2004). The Evolution of Quality

Management in Medicaid Managed Care. Health Affairs, 23, no.4:245-254.

Scoville, R., Little, K. (2014). Comparing Lean and Quality Improvement. IHI White Paper.

Cambridge, Massachusetts: Institute for Healthcare Improvement. Retrieved November

19, 2020, from

http://www.ihi.org/resources/Pages/IHIWhitePapers/ComparingLeanandQualityImprov

ement.aspx

U. S. Department of Health and Human Services, Office of Inspector General. (1998,

September). Lessons Learned from Medicaid’s Use of External Quality Review

Organizations. Retrieved November 19, 2020, from http://oig.hhs.gov/oei/reports/oei-

01-98-00210.pdf

Core Body of Knowledge – Module 1 – QI, QM, QA Page 31 of 31