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Basic common threads of Quality Management.

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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.

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Abraham Flexner

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Quality should be measured.

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E.A. Codman, MD

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Boston surgeon from the early 1900's was a public health pioneer studying hospital outcomes to determine how they could be improved.

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Founded by E.A. Codman

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American College of Surgeons and its Hospital Standardization Program

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The American College of Surgeons eventually became this organization

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The Joint Commission

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E.A. Codman Award

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Given out by the Joint Commission for the use of outcomes measures to advance the quality and safety of patient care.

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In 1918 the American College of Surgeons began to address the fact that patients did not feel comfortable with this concept.

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The operation was a success but the patient died.

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John Williamson, MD

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Recipient of the EA Codman Award in 2000 and is a leader in the field of health care outcomes research and its implementation.

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Outcomes Measures

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Help identify (prioritize) areas for which measuring and analyzing the process are likely to lead to improved outcomes.

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When outcomes do not meet expectations it is appropriate to do this.

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Measure the process producing the outcomes to improve possibly substandard performance.

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Avendis Donabedian, MD

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Brought modern quality assurance techniques to modern medicine by emphasizing structure, process, and outcome.

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Walter Shewhart

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American physicist, engineer, and statistician working in quality control. Developed the Shewhart cycle.

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Renamed the Shewhart Cycle the PDCA Cycle.

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W. Edwards Deming, MD

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Shewhart Cycle consists of the following four phases.

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Plan, Do, Check, Act

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PDCA approach is heavily emphasized in medicine because it embodies the principles of this method.

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Scientific method.

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W. Edwards Deming

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Introduced statistical processes to the industrial quality process because he recognized the importance of having accurate and meaningful information.

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Deming's 14 Points for Management

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1. Create consistency of purpose toward improvement of product and service, with the aim to become competitive, stay in business and provide jobs. 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 workforce. 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 - eliminate quotas and substitute leadership/ eliminate management by objective and 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 the transformation.

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Deming's Seven Deadly Diseases that interfere with achievement of continuous improvement.

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1. Lack of constancy of purpose. 2. Emphasis on short term profits. 3. Evaluation of performance, merit rating or annual review. 4. Mobility of management - job hopping. 5. Management by use of "visible figures" with no consideration of unknowns or unknowables. 6. Excessive medical costs. 7. Excessive liability costs.

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Deming believed this had more impact on quality than the individuals operating within this.

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The system.

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Major proponent of statistical quality control.

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W. Edwards Deming

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Deming's two reasons for undesirable performance.

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Special Cause and Common Cause

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Special Cause

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Results from an unpredicted action on a system. "Blips" on a control chart characterize these special causes to a system.

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Common Cause

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Account for the majority of variations in outcomes from a system - day-to-day variations within a system.

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Helps keep the quality process focused on actual opportunities rather than apparent opportunities for improvement.

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Statistical analysis

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Selecting the proper statistical tool is key to allowing an organization to do this.

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Meaningfully interpret data.

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Special cause and common cause can be differentiated using this statistical tool.

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Control charts.

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Run charts

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Line graphs

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Statistical Control Charts

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Run charts (line graphs) upon which upper and lower standard deviation lines are drawn. Used to differentiate special cause events from common cause events as those with a special cause origin will usually occur outside the upper and lower standard deviations lines.

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Zigzagging occurring within the standard deviation lines on a control chart indicates this.

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Common cause.

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Deming recommends manipulating these systems to have the greatest impact on quality.

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The systems used to produce the product.

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Manipulating systems used to produce the product will have this effect on the distance between the standard deviation lines.

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They will narrow.

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The narrower the standard deviation lines, the process will become more

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Reliable, homogeneous, and reproducible.

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

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Special causes.

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Addressing these will have the most impact on patient outcomes.

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Common causes.

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Joseph Juran

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Introduced the concept of Total Quality Control.

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Total Quality Control theory is based on the trilogy of

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Quality planning, quality control, and quality improvement.

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According to Juran, when many factors influence a system

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Only a vital few factors will significantly change the system.

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Total Quality Control theory is a complementary idea to this concept

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Special cause and common cause

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The vital few factors capable of influencing a system under Juran's Total Quality Control theory are elements of

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Common cause because they have the most influence on a system

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Juran's theory of Total Quality Control emphasizes the need for participation from the

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Whole organization

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Juran proposes this in order to assure adequate consideration to deploy improvement resources and continuous follow up of results.

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A Council

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Philip B. Crosby

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Added the financial consequences of quality performance to basic quality improvement principles.

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Cost of Non-Conformance

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Crosby's theory requiring the calculation of the amount of money spent on mistakes and subtracting what it would have cost to do things right the first time.

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This concept helps quantify the financial benefits of using the quality process.

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Cost of Non-Conformance

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This creates a financial incentive for investing in the quality process.

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Cost of Non-Conformance

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Highlights the savings generated by doing things right the first time.

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Cost of Non-Conformance

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Quality Management

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A broader conceptualization of the approaches to improving quality. It is an umbrella term that covers the entire field of quality review.

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Quality management consists of these nine aspects

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1. Quality Assurance 2. Quality Improvement 3. Continuous Quality Improvement 4. Total Quality Management 5. Credentialing 6. Risk Management 7. Utilization Review 8. Medical Records 9. Infection Control

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Quality Assurance

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Addresses primarily negative outcomes (sentinel events). Seeks opportunities for improvement by monitoring bad events.

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This quality focus area has a long history of being associated with punishment of peers.

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Quality Assurance.

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Quality Improvement (Performance Improvement)

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Seeks opportunities to improve care by improving upon outcomes that are currently considered satisfactory.

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This is associated with the concept of getting better at what is already done well.

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Quality Improvement

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Continuous Quality Improvement

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Builds on previous improvements and uses a systematic process including data analysis to continuously enhance performance.

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Total Quality Management

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encompasses Quality Assurance (improve through monitoring bad events), Quality Improvement (get better at what is already done well) and Continuous Quality Improvement (use of systematic processes and data analysis to continuously enhance performance). Adds to the dimension of organizational improvement and a focus on customer desires.

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Quality focus that includes a focus on customer desires.

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Total Quality Management

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Focuses on negative events to identify opportunities for improvement.

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Quality Assurance.

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Strength of Quality Assurance

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Focuses on events we want to never occur.

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Weakness of Quality Assurance.

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The negative events focused on only affect a small portion of patients.

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This is at risk if quality assurance is the only approach utilized.

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Care will not be improved for the majority of patients.

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Sentinel events

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Subcategory of negative events representing major negative outcomes for which even a single occurrence requires an immediate in-depth analysis and corrective actions so as to promptly protect against a reoccurrence.

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Examples of Sentinel Events

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Unanticipated death, unrelated major loss of function, inpatient suicide, actual rape, infant abduction, hemolytic transfusion reaction, wrong site surgery

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Event provides a notification to the organization of a possible weakness in the care system that is larger in scope than an individual's incompetence.

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Sentinel event

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Represents major vulnerabilities for reoccurrences.

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Sentinel event

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Preferred technique for analyzing a sentinel event.

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Root cause analysis.

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Root cause analysis

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Seeks to determine both the proximal cause (immediate) of an event and the root (underlying) cause.

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A root cause analysis should always include an analysis of these types of issues which include prevailing attitudes or frequently held assumptions.

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Cultural issues

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A root cause analysis is considered incomplete if it does not include this type of assessment.

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Cultural.

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Quality improvement involves both of these types of areas.

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Problem areas and areas with good outcomes in the hopes of making them better.

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This quality focus type deals with both positive and negative outcomes.

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Quality Improvement

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This quality focus is more likely to focus on processes and systems than individuals because improvements for good performance are most often achieved through improved systems.

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Quality Improvement

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Continuous Quality Improvement

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Revisits already improved areas and focuses on a continuous cycle of enhanced achievement.

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Quality focus that focuses on analyzing updated data and information to spot new opportunities to improve processes that have already been addressed.

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Continuous Quality Improvement

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Represents an aggregation of the basic principles of Quality Improvement and Continuous Quality Improvement.

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Total Quality Management

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Uses a systems based approach to focus on the organization and the need for organizational support.

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Total Quality Management.

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Driven by customer desires for improvements to current processes and outcomes.

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Total Quality Management

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Culmination of the quality process.

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Total Quality Mangement

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Lean

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Approach to Quality Improvement originating in Japan with a focus on production systems (grounded in analysis of the actual processes that produce the outcome). Data based and is continuous. Improvements achieved by improving process flow and eliminating unnecessary steps or steps that do not "add value". Findings and improvements target process improvements that can be integrated into daily work.

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Six Sigma

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Quality approach using data-driven information to eliminate defects in order to achieve a theoretical six standard deviations between the mean and the nearest specification limit. To achieve a six sigma performance, a process must not produce more 3.4 defects per million opportunities. Customer driven like total quality management. Aims to both improve process flow as well as reduce process variation. Expands the focus beyond lean process flow to include process management.

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Six Sigma Defect

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Not meeting the customer specifications.

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Lean Six Sigma 5 Phases

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1. Define 2. Measure 3. Analyze 4. Improve 5. Control (follow-up) AKA DMAIC (pronounced duh-may-ik)

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Credentialing

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Assures that the correct individual with the correct skills, correct knowledge, and the correct performance is put in the correct position.

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Quality Assurance and Peer Review are less important in the quality process when this is a cornerstone.

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Credentialling

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Credentialing allows for variances in outcomes to be investigated with the primary focus on these.

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The environment and the systems within which qualified people work.

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When credentialing is performed, the quality approach has more latitude to be

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Supportive rather than punitive if the personnel are competent.

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System approach seeks to introduce these to avoid lapses of judgment by qualified individuals from having negative results.

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Safeguards.

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Risk Management

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Relates to the quality process as it focuses on preventing monetary loss by eliminating negative outcomes. Includes insurance, patient satisfaction, and legal issues.

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Analyzes areas in which an organization or provider may lose money in order to identify opportunities for improvement.

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Risk Mangement

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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

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Uses quality processes to determine what can be done proactively to prevent a reoccurrence of situations that produce risks.

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Risk Mangement

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These two tools help with risk management processes.

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Common database of information and use of medical record analysis.

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Deals with loss prevention on a day-to-day basis.

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Risk Management

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Proactive approaches are used to avoid negative situations. Positive outcomes, satisfied patients, and adherence to regulations all decrease loss potential.

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Risk Management

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Utilization Review

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Formal review of the consumption of all resources used in delivering care to a patient. Traditionally focuses on length of stay or the appropriateness of performing a procedure.

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Includes analyses of specific resources used for a patient and may be prospective, concurrent, or retrospective.

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Utilization Review

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Focuses on improving already successful care by reducing the resources used to achieve the same results.

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Utilization Review

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Medical Records

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Used as a primary source of information in the quality process. Type of record must be validated prior to interpretation; this is best done by contacting the individual responsible for creating the record in order to clarify its status.

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Medical records are useful in the quality process only when

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They are clearly understood

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Four types of records

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1. Good records of good care 2. Bad records of good care 3. Good records of bad care 4. Bad records of bad care

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Infection Control

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Subset of complication rates that also involves analysis of the transmission of illness to providers. Quality control process for Infection Control focuses on outcomes.

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When infection control information is aggregated, it can be used to determine ways to

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Reduce the risk of future infections

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When analyzing Infection Control data and information, the most important question to answer is

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How will we reduce the occurrence or spread of infections for patients, staff or visitors?

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Quality Plan

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A health care organization's endorsed written plan providing a structured process for achieving the identified set of goals and objectives that pertain to the continuing quality improvement process. Overall goal is to achieve organization-wide value and cost-effectiveness from the quality process. Describes the processes to use that can coordinate the functions of all departments and divisions of the health care entity or managed care company.

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Quality plan should be customized this often

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Annually

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Quality plan quality improvement projects should be aimed at

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Risk reduction and continuous improvement of care

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Off track conclusions

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Ought to, should, would, could, suggests the process is getting off track because they are addressing expected performance rather than the reality of the situation.

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2 Process focused models

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Lean and Six Sigma

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Problem using outcomes data as a peer review tool

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The outcomes data measures all aspects of the processes used to achieve the outcome and may not be statistically valid for the individual physician. Analysis of causation may better determine if an individual requires peer review or peer-centered action.

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True or False - Performance rated as adequate or excellent may not meet customers' expectations.

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True.

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Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS)

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First national, standardized, publically reported survey of patients' perspectives of hospital care. Reported by CMS to provide an incentive to create improvements in quality of care and enhance accountability.

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2 factors to be considered when designing an outcomes measure.

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Direct causality and efficiency

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Audits done by this type of reviewer are the least reliable.

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Single reviewer.

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4 steps of an Effective Process Improvement Process

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1. Find an opportunity to improve 2. Assess the opportunity 3. Act on an opportunity 4. Measure results

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Stanley Campbell Research Design

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Pre-test/post-test model of applying a treatment and measuring the results or a time series model

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5 Basic steps of Stanley Campbell, Research Design

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1. Establish definitions, procedures, and scripts to be followed so that there is reproducibility among data collection processes and assure data integrity. 2. Get baseline or pre-test measurement (T1) 3. Apply the treatment for a pre-selected amount of time (X). 4. Measure again (T2). 5. Determine the statistical significance between T1 and T2.

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Peer Review definition by statute

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Evaluation of the total health care provided; includes all forms of quality oversight and specifies protection from discoverability.

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General peer review definition

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When an individual with similar training and expertise does the review of another individual's professional judgment and technical performance. Although not required, when punitive action is being considered against a provider, a professional with similar privileges is the preferred peer.

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Level 1 of Peer Review

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Chart Screening - peers identify the criteria to be used in judging care

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Level 2 of Peer Review

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Patterns and Trends - peers review information to confirm variances or to assess patterns in addition to specific variances.

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Level 3 Peer Review

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Peer Interventions - 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.

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Timely Peer Review

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Review performed within 30 days and completed by 90 days after the issue is identifie.

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Who performs peer reviews?

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Screeners with peer criteria, data analysts, peers

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What Act created the first Peer Review Organizations?

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Title XI of the Social Security Amendments Act of 1972.

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Title XI of the Social Security Amendments Act of 1972 created these physician controlled nonprofit organizations that contracted with HCFA to provide for the review of hospital inpatient resource utilization, quality of care, and medical necessity.

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Professional Standards Review Organizations (PSROs).

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This Act replaced Professional Standards Review Organizations with Peer Review Organizations in 1982 to review quality of care and appropriateness of hospital admissions, readmissions and discharges for Medicare and Medicaid.

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Tax Equity and Fiscal Responsibility Act (TEFRA).

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1993's Quality Assurance Reform Initiative (QARI)

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Assists states in the development of continuous quality improvement systems, internal and external quality assurance programs, and focused clinical studies. Provides a general approach for state Medicaid agencies to follow, but does not offer specific tools or methodologies.

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1996's Quality Improvement System for Managed Care (QISMC)

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CMS developed this to act as a guide to quality management oversight for federal and state health care purchasers and is required of all health plans participating in Medicare and is a voluntary guide for state Medicaid programs.

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1997's Balanced Budget Act (BBA)

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Included new provisions for Quality Assessment and Performance Improvement and a comprehensive revision of federal statutes governing Medicaid managed care.

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2002's Quality Improvement Organization (QIO)

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PROs became QIOs which better describe their proactive role in improving health care. CMS issued a final rule to implement BBA provisions relating to how quality measurement and performance improvement programs should be applied the Medicaid Managed Care. These provisions updated the approach outlined in QISMC and specified that the 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.

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2006's Physician Quality Reporting Initiative (PQRI)

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Established by Tax Relief and Health Care Act of 2006 (TRHCA) and authorized the implementation of physician quality reporting system that establishes a financial incentive for eligible professionals who participate in voluntary quality reporting programs.

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Agency administering the PRO/QIO program

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CMS

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Number of PROs/QIOs

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53

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Purpose of PROs/QIOs

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Ensure the quality, effectiveness, efficiency, and economy of health care services provided to beneficiaries of Medicare & Medicaid.

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3 core functions of QIOs

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1. Improving quality of care 2. 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 3. 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.

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Title XI of the Social Security Act of 1972

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Professional Standards Review Organizations

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Balanced Budget Act of 1997

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Rules used to form current QIOs

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Tax Relief and Health Care Act of 2006

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Physician Quality Reporting Initiative

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Pay for Performance

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Incentive plans used to encourage improvement in quality and efficiency. Hopes to achieve positive change by rewarding providers for the desired achievements.

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CMS Pay for Performance Program

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Individuals performing in the top 10% receive enhanced reimbursement and in the bottom 10% they receive diminished reimbursement.

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Quality Improvement System for Managed Care (QISMC) established this

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A unified oversight system for both Medicare and Medicaid managed care.

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4 Goals of Quality Improvement System for Managed Care

answer

to establish objective and measurable standards to improve the health of Medicare/Medicaid beneficiaries. 1. Clarify the responsibilities of CMS and the states in promoting quality as value-based purchasers of services for vulnerable populations 2. Promote opportunities for partnership between CMS and the states and other public and private entities involved n quality improvement efforts. 3. Develop coordinated Medicare and Medicaid quality oversight system to reduce duplicate or conflicting efforts and send a uniform message on quality to organizations and consumers. 4. To make effective use of quality measurement and improvement tools while allowing sufficient flexibility to incorporate new developments.

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Quality Improvement System for Managed Care requires how many improvement projects per year?

answer

Two

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