Loyola Univ. Health Sys. - Center for Clinical Effectiveness (CCE)

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Quality and Safety Improvement Plan (Revised July, 2007)

I. Overview

Purpose
Loyola University Health System (LUHS), which includes Loyola University Medical Center (LUMC), shall demonstrate through this Quality and Safety Improvement Plan, a systematic, organization wide approach to provide uncompromising, safe, quality care and service to patients in keeping with its mission statement, values and strategic plan.

Mission Statement
Loyola University Health System is committed to excellence in patient care and the education of health professionals. We believe that our Catholic heritage and Jesuit traditions of ethical behavior, academic distinction and scientific research lead to new knowledge and advance our healing mission in the communities we serve. We believe that thoughtful stewardship, learning and constant reflection on experience improve all we do as we strive to provide the highest quality health care.

We believe in God's presence in all our work. Through our care, concern, respect and cooperation, we demonstrate this belief to our patients and families, our students and each other. To fulfill our mission we foster an environment that encourages innovation, embraces diversity, respects life and values human dignity. We are committed to going beyond the treatment of disease. We also treat the human spirit.

Values
Respect - We believe in the value of each person. We are committed to provide respect and care for all life from conception through death.
Concern - We believe that holistic care of the patient includes meeting physical, psychosocial, and spiritual needs. Recognition and support of these needs is a motivating force in our care of patients and their families.
Cooperation - We believe that we have a responsibility to work together cooperatively, with respect, kindness, understanding and courtesy toward each other. We are further committed to reflect these beliefs in our relationships with all persons who come in to our institution.
Care - We believe that providing a caring climate enhances the quality of care. Because we are committed to delivering the highest quality of care possible, we will reflect this philosophy in our work.

Guiding Principles for Providing Quality Patient Care
The key attributes that support our vision of health care services describe a system that:

is centered upon treating persons and families with dignity
provides an integrated continuum of care
demands service excellence
requires effective communication and information sharing
continually improves its operating and clinical practices
is best achieved by teamwork
uses resources optimally
is scientific and results oriented
communicates the need for safety to patients and urges them to report concerns
provides a safe environment for patients, visitors and staff
delivers care based on the best scientific evidence combined with judgment of expert clinicians

Strategic Direction of the Organization
Loyola University Health System's approach to quality and safety improvement is planned, systematic, collaborative, interdisciplinary and based on the strategic direction of the organization. LUHS quality and safety activities include ongoing measurement, continuous assessment and a consistent approach to performance improvement within the context of the strategic direction of the organization.

The strategic planning goals of the organization are:

Position Loyola as the provider of choice
Expand primary and specialty ambulatory care
Provide excellence in patient care
Become a valuable business partner to payers
Promote physician and clinical integration
Improve organizational effectiveness through IS development and system integration
Build capital base

Quality and Safety Program Objectives
Goals for the LUHS quality and safety improvement program are to:

Align the quality improvement and safety program with the strategic direction of the organization on an ongoing basis
Identify and monitor the key quality and safety performance indicators for LUHS
Stimulate the adoption of best practices across the organization
Provide ongoing education for physicians, management and staff regarding quality and safety improvement
Foster use of state of the art, scientific, performance improvement methodology / tools
Improve communication / coordination regarding performance improvement activities across LUHS

Scope of the Quality and Safety Program
The quality and safety improvement plan involves physicians, nurses, pharmacists, allied health disciplines, administrators, managers, staff and contracted services. The quality and safety improvement plan focuses on improving key functions within the organization. These functions include important patient focused functions (ethics, rights and responsibilities, provision of care, treatment and services, medication management, surveillance, prevention and control of infection and national patient safety goals) and organizational functions (improving organization performance, leadership, management of the environment of care, management of human resources, and management of information.)

Aims for Improvement
The patient focused and organizational functions are assessed by collecting and analyzing data related to one or more of the following aims for improvement: safe, effective, patient-centered, timely, efficient, and equitable.

II. Quality and Safety Leadership and Organizational Structure

Leadership
The LUHS Board of Directors, through its Quality and Patient Safety Committee of the Board, delegates authority and responsibility for all matters relative to the Quality and Safety Improvement Program of LUHS and LUMC to the President and Chief Executive Officer of LUHS and LUMC. The President and Chief Executive Officer delegates operational responsibility to the Quality and Safety Coordinating Council, the Center for Clinical Effectiveness, the Medical Staff Executive Committee, the Medical Care Evaluation and Analysis Committee, the Chief of Staff, the Vice President for Quality and Patient Safety and to the operational Vice Presidents for jointly implementing the Program.

Organizational Structure, Function and Plan Implementation

Quality and Patient Safety Committee of the Board
The Quality and Safety Improvement Plan is supported by the Quality and Patient Safety Committee of the Board, with members appointed by the LUHS and LUPF governing boards. Membership includes physician, nursing, administrative and board representatives.

The Quality and Patient Safety Committee of the Board provides leadership, guidance, authority and accountability for performance improvement and safety throughout the health system organization and is responsible for the integration, coordination, and communication of performance improvement and safety activities of LUHS and the faculty group practice, LUPF.

Organization wide performance is reported to the Quality and Patient Safety Committee of the LUHS and LUPF Boards on an ongoing basis through a variety of mechanisms including review and analysis of the System Assessment Measures, reports from departments responsible for major components of organizational quality and safety, reports of root cause analysis of adverse events, reports of risk assessments, such as failure mode and effects analysis reports, and reports of significant quality improvement projects. The System Assessment Measures include an analysis of LUHS performance and include both internal and external comparators. Intensive analysis and quality improvement activity are initiated and evaluated as needed.

The Quality and Patient Safety Committee of the LUHS and LUPF Board meets regularly to:

Establish and review priorities
Monitor progress, as required
Report to the governing board

Quality and Safety Coordinating Council
The Quality and Safety Coordinating Council (QSCC) facilitates integration of quality and safety into operations. The council meets regularly to provide leadership and oversight for quality and safety improvement activities, facilitate integration of quality and safety activities into operations, coordinate quality and safety improvement activities across LUHS, identify and prioritize system-wide opportunities to improve quality and safety and prioritize use of system resources for quality and safety activities. QSCC membership includes representatives from operations, quality and safety, the office of patient safety and risk management, environmental and occupational health, nursing and medical staff.

The Quality and Safety Coordinating Council refers key quality and safety issues as appropriate to:

Quality and Patient Safety Committee of the LUHS Board
Medical Executive Committee
Loyola University Physician's Foundation
Clinical and administrative leadership
Office of Corporate Compliance

The Patient Safety Committee
The LUHS Patient Safety Committee, a subcommittee of the Quality and Safety Coordinating Council, is a multidisciplinary group of clinicians, staff and managers whose charge includes:

Help lead and coordinate efforts to gain a clear understanding of the state of patient safety throughout LUHS
Collaborate with the Quality and Patient Safety Committee of the Board and the Quality and Safety Coordinating Council to develop a culture and system that encourage reporting of patient safety events and near-misses by physicians, administrators and staff
Assist in leading efforts to identify and prioritize system-wide opportunities to improve patient safety
Propose mechanisms needed to ensure that the LUHS Board as well as physician and administrative leadership are informed about patient safety and the results of the LUHS patient safety program
Identify opportunities and mechanisms to educate the LUHS community about patient safety
Identify opportunities and mechanisms to educate and involve patients and families in the LUHS patient safety program

The Patient Safety Committee reports its activities and recommendations to the Quality and Safety Coordinating Council

The Center for Clinical Effectiveness
The mission of the Center for Clinical Effectiveness (CCE) is to catalyze improvement in the quality and value of health care services provided at Loyola University Health System.

The Center for Clinical Effectiveness coordinates performance improvement activities across LUHS, helps to prioritize LUHS performance improvement efforts, identifies and implements state of the art quality and safety monitoring, analytic, and improvement tools, and communicates results of performance improvement work within LUHS and externally to the community, customers, payers, health care industry, and academic colleagues.

The Center for Clinical Effectiveness:

reviews indicators, indicator data and reports on performance improvement and safety efforts, in order to identify significant opportunities for improvement and to evaluate the quality and safety improvement process.
reports results of quality and safety monitoring and improvement activities to Quality and Patient Safety Committee of the Board, senior management, medical leadership, the Quality and Safety Coordinating Council and other groups as appropriate.
leads periodic review of the LUHS Quality and Safety Improvement Plan to assure that the plan integrates the current direction of the organization, reflects organizational priorities and incorporates current concepts in quality improvement and patient safety.

Clinical Departments, Divisions, Service Lines and Organizational Departments
Clinical Departments, Divisions, Service Lines and Organizational Departments assess the quality of care provided in their areas. The departments, divisions and service lines identify opportunities for improvement, develop solutions, implement recommendations and analyze results, utilizing appropriate quantitative and statistical approaches, in order to improve the quality and safety of care. These units work independently or collaboratively as appropriate to the patient population, services provided and organizational structure. Priorities for performance improvement may be determined utilizing the LUHS prioritization criteria.

Clinical Departments, Divisions, Service Lines and/or Organizational Departments will:

review and report to their respective vice president and the CCE on trended indicator data, including charts or graphs, as appropriate
identify opportunities to improve patient care, and when requested provide a brief report to the QSCC on the status of performance improvement and safety projects utilizing the LUHS quality improvement approach.

Medical Staff Committees
Medical Staff Committees assess quality and safety of care and opportunities for improvement. Processes are reviewed according to the requirements for the monitoring of blood and blood product use, medication management, operative and invasive procedures, medical records, infection control, utilization management and pain management. Other issues related to all aspects of care and all settings in the continuum of care may also be reviewed.

Medical Staff Committees meet regularly to:

review trended indicator data
Identify opportunities to improve patient care
Provide reports to the Medical Executive Committee on the status of problem areas and performance improvement initiatives

Nursing Quality Committee
The Nursing Quality Committee meets regularly to evaluate and analyze nursing care, nursing system issues and nursing overall and unit specific quality data for the improvement of patient care.

Quality and Resource Management
The Quality and Resource Management department concurrently reviews inpatient admissions. Upon review, all mortalities and cases with potential for suboptimal clinical outcome are referred to the Chief of Staff, who reviews the case and either assigns a standard of care or refers it to the appropriate clinical or ICU director for review. After this peer review, cases assigned a level 3 standard of care (opportunity for improvement) or level 4 standard of care (medical mismanagement) receive another review by the Chief of Staff and the Medical Care Evaluation and Analysis Committee. Significant events are incorporated into the physician's performance profile for consideration at reappointment. In this manner, all cases with significant adverse outcomes are evaluated to identify opportunities to improve care and to identify sentinel events.

Medical Care Evaluation and Analysis Committee
The Medical Care Evaluation and Analysis Committee is a Medical Staff Committee that meets at least twice monthly to identify, evaluate and investigate events and occurrences associated with, or resulting in any adverse clinical outcome, patient dissatisfaction, or near miss. The Medical Care Evaluation and Analysis Committee is responsible for determining which occurrences are sentinel events and for directing the conduction and completion of root cause analyses. Recommendations to enhance quality of care and patient safety are implemented as appropriate. The Committee will report its findings, conclusion and recommendations to the Medical Executive Committee periodically, as appropriate.

Environmental Health and Safety Committee
The Environmental Health and Safety Committee focuses on issues related to the environment in which patient care services are delivered. Ensuring a functional, supportive and safe setting for patients, faculty, staff and visitors is vital. The committee develops, implements, monitors and evaluates processes and programs aimed at maintaining a safe environment. The committee is organized into specific disciplines reflective of the various components of the Environment of Care: safety, security, hazardous materials and waste, emergency management, fire safety, utilities and equipment management. These subcommittees identify performance indicators and relevant benchmarks and conduct process improvement processes that are evaluated monthly and reported to the Safety Committee. The Environmental Health and Safety Committee meets regularly and reports to the Quality and Safety Coordinating Council and the Quality and Patient Safety Committee of the Board.

III. Quality Improvement Methodology

New Service and Process Design
New services are designed, product lines extended, and functions or processes are changed based on the mission, values, guiding principles and strategies of the organization, following input from community, patients, staff and others. New processes and services are developed or modified incorporating the needs and expectations of patients, staff and others, the results of performance improvement activities when available, information about potential risks to patients when available, current knowledge from scientific and professional resources, available guidelines and practice parameters, external benchmarks sentinel event alert information, and proactive risk assessment. Those directly involved in delivering the service or participating in the processes are closely involved in the planning and implementation phases.

As new services and processes are designed and modified, mechanisms to evaluate them are planned and implemented. Measures of performance and targets are set and monitored. Patients, care providers, staff and other stakeholders are involved in the evaluation process.

Measurement
Performance improvement monitoring and evaluation standards are system-wide comprehensive, department, division, service line or population focused and require the following:

identification of measurable indicators for monitoring the processes or outcomes of care
collection of data for ongoing measurement
evaluation of performance against pre-determined thresholds
evaluation of effectiveness of action
reliance on the scientific method

Performance improvement indicators are selected from the following categories:

Access - How easy it is for a patient, referring physician or payer to obtain desired services in a timely manner
Clinical - Biological consequences of clinical evaluation and treatment
Key Processes - Significant methods used to provide services
Functional Status - Patient's ability to perform day to day activities
Satisfaction - How well we are meeting the needs of our customers
Human Resources - Capabilities, satisfaction and availability of those who provide services
Financial Measures - Financial aspects of care delivery

Certain processes and outcomes are measured on an ongoing basis. These include processes that affect a large percentage of patients, are high risk to the patient and/or are problem prone, such as:

operative and other invasive and non-invasive procedures that place patients at risk
medication management
use of blood and blood products
restraint use
care or services provided to high risk populations
appropriateness of admissions and hospital stays
nosocomial infections in targeted populations
outcomes related to resuscitation
utilization management
National Patient Safety Goal compliance
department, unit or condition specific indicators including the JNational Hospital Quality Measures
nursing quality indicators
pain management
organ procurement effectiveness
staffing effectiveness
risk management

Specific departments, divisions and / or service lines carry out these measurement functions and these are listed in this plan under the specific department / service responsibilities. Medical staff departments carry out medical staff peer review.

Data are collected about the need and expectations of patients and families and their perceptions regarding the degree to which these needs and expectations have been met. Patient reported data are collected to help identify opportunities to improve the quality and safety of care. Data are also collected about staff opinions and needs, staff willingness to report unanticipated adverse events, and views regarding current performance and opportunities for improvement.

Data are collected regarding autopsy activity results, risk management activities, utilization management activities and quality control activities. Quality control activities are performed in the following areas as well as others: clinical laboratory, diagnostic radiology, dietary, nuclear medicine and radiation oncology services. The data collected are monitored and trended in relation to clearly defined internal and/or external standards for quality.

Performance Improvement
Continuous quality improvement provides a methodology to integrate and improve all processes. Continuous quality improvement involves:

emphasis on governance, management and clinical leadership
explicit methodology for priority setting
considers all governance, support, managerial and clinical processes that affect patient care processes and outcomes
active participation of patient and staff to direct improvements
reliance on the scientific method with an emphasis on strategic use of data

All members of the LUHS community are expected to assist in the identification of significant focused opportunities for improvement. In order to identify those opportunities of most value, each potential focused improvement project should be assessed for the degree to which it supports or improves the following:

LUHS mission / strategy
Clinical outcomes
Key processes
Financial outcomes
Project feasibility

The Center for Clinical Effectiveness serves as a resource for all quality improvement and safety projects. For those improvement projects that have primarily single division, department or service line impact, the CCE will provide active consultation, information from LUHS databases and analytic support on an as needed basis. The Quality and Patient Safety Committee of the Board will assign CCE resources and ongoing active participation to those projects with broad institutional or system-wide impact. Such projects may also receive support from Quality and Resource Management and/or other departments as determined and prioritized by the Quality and Patient Safety Committee of the Board and/or Quality and Safety Coordinating Council.

The CCE will help the Quality and Patient Safety Committee of the Board and/or the Quality and Safety Coordinating Council identify projects with broad LUHS impact through the following:

ongoing discussions with faculty, staff and management
regular analysis of internal and external information resources
evaluation of quality improvement reports it receives regularly
regular analysis of safety events and risk assessments

LUHS Six Step Quality Improvement Process
Core elements of the performance improvement approach used at LUHS are:

PLAN

1. Opportunity / problem identification and desired outcome
The opportunity or problem statement is a brief, clear statement of the issue to be studied. Ideally this will be identified through previously collected data. The opportunity statement must be specific, and describe an observable, measurable, manageable issue. The scope should be clearly defined and addressable in a short time frame, i.e., several weeks to a few months. The desired outcome is the specific, measurable objective of the project.

2. Identify most likely cause(s) through data
The cause(s) of a problem may be identified by reviewing relevant existing data, collecting baseline data on several items thought to be most likely causes of the problem, and/or by best guesses of those individuals with the most knowledge of the issue.

3. Identify potential solution(s) and the data needed for evaluation
Utilizing the most likely causes identified in step 2, list potential solutions that may result in the desired outcome(s). Such solutions may be based on experience of others, published reports, and/or best guesses of those with knowledge of the issue. Following this, choose one or more solutions that can be reasonably instituted.

For each solution to be implemented identify those data elements required to determine whether or not the change(s) produced the improvement desired. Data collected should be the absolute minimum and of importance to patients and to the people doing the work. Once the required data elements have been specified, the source of these data must be identified or developed.

4. Implement solution(s) and collect data needed for evaluation
The solution(s) most likely to be successful should be implemented. It is often preferable to do this on a small scale to see if the change(s) will work.

Make the data collection easy enough and the time frames short enough so that data collection can be repeated frequently to allow for trending of changes over time. Avoid trying to collect data for improvement and research purposes simultaneously, as the time frames and amount of data required are dramatically different. If not already available, build in baseline measures before implementing change so that it will be possible to measure whether an improvement has been produced. Finally, provide training, appropriate tools, and examples to those who will be collecting the data before data collection occurs.

STUDY

5. Analyze data and develop conclusions
The objective of data analysis is to test your theory regarding whether or not the change(s) made has led to the desired outcome. It is essential that both the data elements and the anticipated analysis be planned before changes are implemented. This will often require the advice of a statistical consultant, a service offered by the Center for Clinical Effectiveness. In the absence of a reasonable statistical analysis of carefully collected data, it is often impossible to determine whether or not the tested solution has produced the improvement desired.

ACT

6. Recommendation for further study / action
Action in this step depends upon the results of data analysis. If the tested solution was shown to produce the desired change, one may wish to more broadly implement if the initial test was done on a small scale. Effectively communicating the results of the test, as well as rewarding those involved in the improvement is important. Finally, one should decide whether or not it is important to continue collecting data to monitor whether the observed improvement is sustained over time.

If the tested solution did not achieve the desired improvement, those with knowledge of the process should meet to determine why success was not achieved, i.e. return to Step 2 of this process and then repeat the cycle to test other potential solutions to the problem at hand.

Aggregation and Analysis of Data
There is a systematic process, relevant to both quality and safety improvement activity projects and performance measurement, to aggregate and analyze collected data. Data are assessed in order to determine:

priorities for improvement
actions for improvement
whether changes in the process resulted in improvement
meeting of design specifications
performance and stability of important existing processes

This assessment process includes using statistical quality process control techniques, as appropriate and comparing data about processes and outcomes over time. Performance is also compared to relevant scientific, clinical and management literature, and to relevant practice guidelines / parameters, as appropriate.

The quality and safety program emphasizes intensive assessment when undesirable variation in performance occurs. An intensive assessment is initiated in response to:

important single events including those in which no harm occurred (i.e. near misses)
absolute levels or trends that significantly and undesirably vary from those expected based on appropriate statistical analysis
performance that significantly and undesirably varies from that of other organizations or from recognized standards (Sources of external benchmark data include but are not limited to UHC, MIDAS and Illinois Hospital and Health System Association)
a desire to improve already good performance

IV. Confidentiality and Conflict of Interest

Confidentiality
All data and recommendations associated with this Quality and Safety Improvement Plan are solely for the improvement of patient care. As such, all material is confidential and is accessible only to those parties responsible for assessing quality and safety and competency, and to those external agencies responsible for accreditation and licensure of Loyola University Health System.

V. Approvals

Approved by Loyola University Health System in July, 2007

______________________________ Dated___________________
William Cannon, MD
Chief of Staff

______________________________ Dated ___________________
Paul K. Whelton, MD, MS
President and Chief Executive Officer