From Inspection to Improvement:
Quality Process Development in the Department of Anaesthesia at the QEII Health Sciences Centre
John Blake, Dalhousie University
1 Introduction 

The scene is a busy emergency room in a crowded inner-city urban hospital.  The sick, the injured and the dying arrive at a dizzying pace.  Groups of dedicated, self-sacrificing professionals move quickly and efficiently, somehow rising above the chaos of their surroundings, to deliver complex, critically needed services to gravely ill patients. 

The doctors in this scene are consummate professionals.  They have fantastic knowledge, wonderful bedside manners, an inexhaustible supply of technology, and endless amounts of time and energy.  They never make mistakes, except today.  Today, the young resident, who has been on shift for 36 hours misreads the label and accidentally injects her patient with a drug that causes her patient to suffer heart failure.  The mistake is quickly realized and steps are quickly taken to correct the problem.  The patient survives, but the harm is done.  The young resident, Dr. Elizabeth Corday, is required to report the incident to the senior attending physician, Dr. Mark Greene.  A full-fledged investigation is undertaken.  Dr. Corday is eventually cleared of any criminal wrong doing, but not before having to appear at rounds to give a report concerning the incident.  She is asked difficult and embarrassing questions about the incident.  One can almost feel Dr. Cordayís embarrassment and loss of personal and professional esteem as she tries to justify her actions.  The scene, of course, is fiction it is a synopsis of a plot line from televisionís drama series, ER but it closely mirrors the reality of how quality is managed in some health care facilities. 

In the fall of 1998, a new Quality Improvement Officer (QIO) and a new Head of the Quality Improvement Program (QIP) were appointed in the Department of Anaesthesia at the Queen Elizabeth II Health Sciences Centre.  Prior to the appointments, quality was viewed as quality assurance an inspection process designed to address problems after the fact.  The new Head brought a new focus to the Department; one in which quality improvement was to take priority over quality assurance and administrative duties.  A number of quality improvement projects designed to prevent problems from occurring had been implemented during the Headís first year.  Now, with the transition from inspection to quality improvement well under way, the Head wished to adopt a framework that the Department of Anaesthesia could use to manage a quality improvement program.  The Head of the QIP identified four possible courses of action: 
1. Continue to undertake small focused studies. 
2. Adopt the QEII Quality Model 
3. Adopt ISO 9000 standards, either with or without certification 
4. Adopt Malcolm Baldrige National Quality Award (MBNQA) standards. 

2 Background 

The Queen Elizabeth II Health Sciences Centre (QEII), located in Halifax, is the largest health centre east of Montreal. The QEII provides specialized care to Nova Scotians as well as citizens of New Brunswick and Prince Edward Island.  In addition, the QEII also provides a complete range of health care education programs, and general hospital services for Halifax and other parts of the Central Health Region of Nova Scotia (QEII, 1999).  The QEII occupies 10 buildings on four sites and is the result of provincial legislation that officially merged the Victoria General Hospital, the Halifax Infirmary, the Nova Scotia Rehabilitation Centre, and the Camp Hill Veterans' Memorial Hospital in 1996.  The resulting hospital has an annual operating budget of $340 million and treats about 31,000 inpatients each year.  In addition to its inpatient services, the QEII provides approximately 425,000 outpatient clinic visits, 70,000 emergency room visits, 334,000 diagnostic procedures, and 158,000 outpatient treatments such as physiotherapy and occupational therapy. The hospital has 1,100 inpatient beds, including 175 beds dedicated to veterans. As of 1999, approximately 6,500 people worked at the QEII. 

2.1 Department of Anaesthesia 

Anaesthesia is the specialty of medicine that is concerned with the support of physiology and the control of pain in association with surgical, diagnostic or therapeutic procedures (Department of Anaesthesia, 1997).  The Department of Anaesthesia at the QEII Health Sciences Centre consists of 42 full and part time anaesthetists, 8 medical residents, 20 anaesthesia technicians, a quality improvement officer (QIO) and 2 support staff.  The Chair/Clinical Chief, the Associate Chief, and an Executive Committee of anaesthetists manage the department. 

 The function of the Department of Anaesthesia at the QEII is to support and promote the mission of the hospital through the practice of anaesthesia and to promote education and research.  The clinical components of the departmentís mission include anaesthesia care for therapeutic, diagnostic and surgical procedures.  In addition the department manages critical care (ICU) medicine and provides acute (short-term, post-surgical) pain management services, chronic pain (long-term) management services, and acute patient ressuscitation services.  The departmentís educational commitment involves medical education at the undergraduate and graduate levels, training of allied health care providers (respiratory therapy, nursing, physiotherapy) as well as in-house training and certification of anaesthesia technologists.  The department engages in both basic and applied research and receives research funding from national granting agencies as well as commercial organizations. 

3 Quality in the Department of Anaesthesia 

When the Halifax Infirmary and the Victoria General Hospital amalgamated in 
1996, the quality assurance functions in the two anaesthesia departments were combined into one quality Improvement Program (QIP) and an anaesthetist was appointed as Head of the program. To help deal with the increased administrative load of the combined quality  improvement program, a full time staff person was hired as a Quality Improvement Officer. 

The natural difficulties inherent in combining two large complex institutions with their own unique cultures resulted in an unstable organizational situation.  During the two years following the merger, the Quality Improvement Program (QIP) focused on traditional quality assurance techniques and efforts to improve key administrative processes.  In particular, a great deal of effort was spent on improving the process of scheduling anaesthetists into operating rooms.  Because anaesthetists are independent entrepreneur/agents, their income is directly tied to the number of services they perform.  Thus, scheduling is a real concern since it dictates the number and type of services anaesthetists will perform and determines the income an anaesthetist receives.  Responsibility for scheduling was taken on by the QIP on the understanding that an improved scheduling process would lead to better staff morale.  Unfortunately, the complexity of the scheduling process at the QEII was rather overwhelming.  Upwards of 60% of the Quality Improvement Officerís time was devoted to this single activity by the fall of 1997. 

3.1 Quality Assurance 

Prior to the Fall of 1998, Quality assurance had been a major focus and activity of the Quality Improvement Program in the Department of Anaesthesia.  Quality assurance in this context involves a process of identifying and investigating incidents known as Ďadverse patient outcomesí.  Adverse patient outcomes are defined as any significant negative variation from a patientís expected course of treatment.  Incidents can be identified in one of four ways: self-reporting, other provider reports, patient complaints, or an after-the-fact review of medical records. Anaesthetists report approximately 12 incidents annually, while other staff report one or two incidents per year.  In addition, one to two patient complaints are received annually.  After-the-fact analysis of patient records comprise the largest source of adverse outcome reports.  Each month the Medical Records Department at the QEII identifies 50-60 cases where patients have suffered a complication.  Complications are identified by the presence of one of several indicators in the patientís discharge record.  Indicators include serious complications such as death or prolonged ICU length of stay as well as administrative issues such as delayed discharge. 

When an adverse patient outcome is identified, the Quality Improvement Officer reviews the patientís medical record to determine if there is any potential anaesthesia involvement.  In approximately 70% of the cases identified through the medical records review, it is evident from the patientís chart that anaesthesia did not play a part in the problem.  For example, an elderly patient with a pre-existing heart disease expires post-operatively.  If it is clear that anaesthesia had no role in the situation, no further action is taken on the file.  In the remaining 30% of the cases, the record may be unclear or may indicate potential anaesthesia involvement.  The cases are referred to the QIP Head for further review.  The Head reviews the chart and, if necessary, speaks with the principals involved.   If process changes are indicated by the review, the QIP makes these recommendations known to the entire department.  Otherwise, information from the formal evaluation is stored, on paper, in narrative form in incident reports.  The narrative information is cross-referenced and stored in files kept on individual anaesthetist performance.  In many senses, these are considered and treated as disciplinary records by both the QIP and the medical staff of the department.  Because of the sensitivity of the data contained in the files, no data compilation of the incident reports is performed.  As a result critical incidents are not tracked or reported for quality management purposes. 

The current quality assurance program is considered to be sufficient and adequate by many members within the Department of Anaesthesia.  It meets regulatory requirements for risk management and is consistent with the quality control methods used in many other anaesthesia departments in Canada.  The old adage "If it ainít broke, donít fix it" applies to this program.  In particular, the program as it is defined now, places a minimal demand on the departmentís management.  This is an important issue in a clinical department in which management tasks are a burden for which individuals are not compensated.  Much like a university, management tasks are considered part of an administrative load.  Individuals are not compensated for these activities, but are expected to take on their share of the load to ensure that the department functions smoothly.  Administrative tasks, in this context, are seen as a distraction from the real business of providing patient care.  Individuals with substantial administrative tasks, such as the Department Chair, the Associate Chief, and the Director of the QIP do receive a small stipend from the hospital in exchange for a proportion of their work.  However, these stipends cover only a small portion of the clinicianís working time (approximately 20%) and usually pay less than the person could make if he or she devoted his or her time to clinical practice. 

3.2 Quality Improvement Initiatives 

The QIP, like many in manufacturing sectors of the economy, had its genesis in inspection based monitoring necessitated by regulatory and legal requirements.  The new Head of the QIP recognized the benefits of proactive quality management: improved responsiveness, lower error rates, better staff relations and an increased emphasis on customer satisfaction.  Despite a focus on traditional quality assurance, the QIP initiated a number of quality improvement projects in the areas of information systems, clinical process management, patient satisfaction and continuing education. 

3.2.1 Clinical Data Management System 

The QIP was actively involved with the specification, design and purchase of a clinical data management system. The system consists of a database that interfaces with anaesthesia machines.  During surgery the system records anaesthesia interventions and patient vitals directly from the machine.  The system, which is considered to be state of the art, generates reports about drug use, anaesthetist practice and patient outcomes that can be used for management purposes and as a basis for continuous improvement efforts. 

3.2.2 Perfusion Database 
The QIP developed a database to track clinical and demographic data of patients treated by cardiac perfusionists.  The database is similar to others in existence at teaching hospitals in Canada and is used to document the clinical expertise of perfusionists (physicians who operate heart-lung machines) at the QEII as well as acting as a source of information for quality management and research studies. 

3.2.3 Hypothermia and Laparoscopic Studies 
The QIP undertook a number of quality initiatives to improve its clinical processes.  During the summer of 1999, the QIP investigated a perceived increase in the number of patients entering the Post-Anaesthesia Care Unit (PACU) in a hypothermic state.  (When patients are anaesthetized, heat is lost at a rate greater than that at which the body can generate it.  If surgery is lengthy and specific intra-operative actions are not taken to warm the patient, hypothermia can occur.)  Nursing staff had expressed concern about the number of patients entering the PACU in a hypothermic state, which they felt was related to the ambient temperature in the surgical suite.  Since discharge from the PACU requires that patients be stable and have a temperature above 35C, hypothermia is both dangerous for patients and detrimental to the operations of the surgical suite.  The QIP team, in conjunction with nursing staff and management in the PACU undertook a focused quality study to resolve this problem. Study parameters included patient information, date, time, oral (by mouth) and tympanic (by ear) patient temperature on arrival to the PACU and ambient Operating Room (OR) temperature. The study was conducted over a one-week period and included all patients whose surgeries had taken longer than 120 minutes.  Results from the data did not support a correlation between ambient OR temperature and patient temperature.  The data collected did, however, show a significant variation in the recorded temperature of patients between the two measurement techniques.  Variations of up to 2C were recorded on the same patient. 

When these results were presented to nursing staff in the PACU, a change in operating policy was adopted.  If a patient presents to the PACU with a hypothermic temperature reading, a second temperature is now taken using a different measurement method.  Only if both methods indicate a temperature less than 35C is the patient to be considered truly hypothermic. 

A second study was initiated to shift the process for managing laparoscopic  cholecystectomies from an inpatient procedure to an outpatient setting.  A laparoscopic cholecystectomy is the removal of gallstones and the gall bladder using a specially designed instrument that permits minimal access surgery.  This technique involves four or five minor openings in the abdomen of approximately 2cm instead of a large abdominal incision. Under the laparoscopic procedure, patients experience less pain than in traditional, more invasive surgical techniques. Hospital stays and post-surgical convalescence are hence shorter.  Because of the advantages of the laparoscopic procedure, it has been the standard for surgical treatment of gallstones since 1992 (National Institute of Health, 1992).  In most institutions in North America patients undergoing laparoscopic procedures are not hospitalized, but are treated on an outpatient basis; they arrive at the hospital, have the procedure and are discharged all on the same day.  At the QEII, however, only 70% of patients undergoing laparoscopic cholecystecomies are treated as outpatients.  The hospital would like to raise this figure to 90% in keeping with other major centres in Canada.  Accordingly, the QIP established a process redesign effort to achieve this goal. 

3.3.4 Staff Education 

In addition to its information systems and clinical process evaluation efforts, the QIP initiated two staff education programs.  One program was initiated to maintain, track and improve airway maintenance skills among respiratory therapists (RTís).  The second project managed by the QIP involved the creation of a system for documenting and monitoring the experience of student anaesthetists during their rotations in the operating rooms at the QEII. 

3.3.5 Customer Satisfaction Program 

The QIP began a program of tracking customer satisfaction.  Using a survey mechanism designed for a Montreal area hospital, a pilot survey of 39 persons was undertaken in 1998.  The survey collected patient demographic information as well as data regarding the competence, communication skills and availability of their anaesthesia provider.  The pilot data is being used as a baseline for comparison as the department implements an ongoing patient satisfaction survey. 

4 The Decision 

As a result of the successes with the quality improvement initiatives, the Head of the QIP called a meeting of the Department of Anaesthesiaís management group to discuss the future of the QIP.  The following points were discussed: 

a) Changes in the external environment necessitate a change in the programís focus. These changes relate to reductions in health care funding in Nova Scotia and an increased focus on quality improvement in the United States.  During the 1970ís and 1980ís annual increases in health care expenditures greatly exceeded both the rate of inflation and the rate of population growth combined.  However, by 1999, the provincial government was forced to declare a budget deficit ($502 million) of which 40.8% was due to overspending on health care.  Given the severe financial pressure health care places on the provincial economy over the next three to five years funding to hospitals will likely decrease substantially. 

b) In this era of retrenchment, it will become increasingly important for the QEII to make the most efficient use of its resources.  This is a matter of concern not only for the hospitalís administration, but for the medical staff as well.  As resources become more constrained, it will be increasingly difficult for the hospital to maintain its volume of patients.  It is therefore in the interests of both the hospital and its medical staff to improve process efficiency. 

c) While there are a number of financial reasons to argue for a shift towards a quality improvement focus, arguments for a shift in focus can also be made from a quality standpoint.  One of the central tenets of the QEII and its medical staff is to deliver the best quality care possible to patients.  A proactive quality improvement program offers an opportunity to anticipate quality concerns before they happen and take steps to continuously improve both services and their delivery mechanisms.  A proactive quality improvement program is the next logical step for an organization concerned with the well being of its customers.  Additionally, the data collection and management systems, required of a quality improvement process could provide researchers at the QEII and Faculty of Medicine at Dalhousie University with a source of information that can be used for clinical, operational, and quality research. 

d) Finally, a compelling argument for a shift in focus comes from the United States, where quality management is much more developed than is the case in Canada.  This is, in no small part, due to the fact that many US institutions are private ventures.  As such, management techniques drawn from industrial sources are more common and more widely accepted in the US.  (Health care in the US is a vast industry, consuming more that 15% of that nationís GDP or about $1.0 trillion dollars).  In the US, quality has become a serious management concern, fuelled in part by the rise of health maintenance organizations and the need to protect consumers in a market where the insurance function and the provider function of health care are co-mingled.  This has lead to a strong regulatory push in the US to promote quality improvement programs.  For example, all institutions in the United States participating in Medicare or Medicaid programs are required to have a quality improvement program in place.  Furthermore, their operations are reviewed by external, independent quality evaluation and improvement organizations called Quality Improvement Organizations.  Created in 1983 and known as Peer Review Organizations (PROís), these groups originally conducted case after-the-fact reviews to detect over-use or under-use of services (American Health Quality Association, 1997).  However, like many industrial organizations, PROís evolved quickly from quality assurance programs to data-driven, statistically valid quality improvement efforts. 

The management group decided to implement a quality improvement program.  Some members of the group then expressed a strong desire to let the quality management program develop organically.  They felt that the existing program was successful and they proposed that the QIP build on this success by continuing to undertake small focused studies as the need arose.  The Head of the QIP argued that the department should adopt a framework that would define the program and guide its activities in the future.  The Head asked the group to consider three possible frameworks. 

5 Frameworks 

5.1 QEII Quality Model

Since its inception, the QEII has had a strong quality management group, known as the Planning and Quality Resources Department (PQRD).  The department consists of eighteen persons including quality consultants, analysts, industrial engineers, lawyers and clerical and support staff.  The Departmentís mission is to support patient care by providing evidence-based decision support for strategic planning, quality initiatives and risk management.  PQRD is a staff function.  It provides expertise to users to support their quality initiatives and the development of evidence-based decision making.  In addition, PQRD has responsibility for managing the hospitalís risk management program and for providing patient advocacy services.  PQRD has been involved in a variety of projects including Y2K compliance and risk analysis, strategic planning, support staff workload planning, and clinical process redesign.  At any given time, PQRD may have as many as 70 projects on the go. 

One of PQRDís key projects was the development of a quality model that incorporates a patient-centered focus and a continuous improvement cycle.  Through the efforts of the PQRD, the QEII has adopted the quality principles of the National Quality Institute and has linked those principles with the hospitalís vision, mission statement and strategic initiatives to produce a generic framework for quality improvement in which outcomes and evidence based decision-making feature prominently. 

Despite the presence of this group, there has been relatively little interaction between the hospitalís quality department (PQRD) and the QIP run by the Department of Anaesthesia.  The rationale for this disconnect is the unique nature of the professional service provider group in a hospital corporation.   Because professional service providers, such as surgeons and anaesthetists, are independent patient agents, no employment contract exists between hospitals and their associated medical staffs.  Accordingly, relations between these two groups do not follow traditional employee-employer patterns. Harris (1977) noted that the hospital is not one organization, but two.   Doctors control one part of the hospital; the other is run by hospital administration.  These two separate firms are locked in a non-cooperative game for control of the organization and its resources.  This separation is both a historical accident and purposeful policy. 

For the most part, independent service providers (doctors) deliver health care in Canada.  Service providers are not employed by hospitals, or the government, but are rather employed by their patients as agents, whose job it is to determine the number and type of services the patient requires and to provide or secure those services.  Historically, patients were billed directly for these services.  Since the implementation of Medicare for hospital based services in Canada in 1957 and its extension to all medically necessary services in 1970, physicians have billed the provincial insurance program for their services.  Nevertheless, it is the patient, not the government, who actually employs the physician. Thus, there is no formal employment relationship between the hospital and the physicians who comprise its medical staff.  Physicians do not work for the hospital, rather they work in the hospital, using the hospitalís resources to provide services and thus generate income. 

The divide between service providers and hospital corporations is designed to prevent collusion between hospitals and physicians.  In theory this is an elegant solution to a complex problem.  In practice, however, it creates some difficulties.  Hospitals do not, for instance, control physician practice.  The hospitalís authority is strictly limited to the efficiency of service delivery. Thus, the management hierarchy must negotiate with the medical hierarchy on matters of policy and control (Harris, 1977).  The dual structure of the hospital corporation is primarily responsible for the divide between the Department of Anaesthesiaís QIP and the hospitalís PQRD. 

5.2 ISO 9000 Series of Standards 

As a framework, the ISO 9000 series of standards, with or without formal certification, provides a number of potential benefits.  ISO 9000 is a rigorous, validated set of standards with worldwide application and acceptance.  Use of this standard would signal to consumers that the Department aspires to an internationally recognized level of quality.  In addition, the brand-name recognition afforded by the ISO 9000 series of standards means that the QIP would have little difficulty explaining the purpose of the framework to consumers and other providers. 

Despite great worldwide acceptance in many manufacturing and service industries, the first hospital ISO registration in the US took place only in 1996 and only a handful of hospitals in the US have received ISO registration.  The number of health care institutions in Canada with any experience in ISO 9000, outside of laboratory services, numbers less than half a dozen.  The main reason for the slow penetration of ISO 9000 into health care is that the language in the 1994 ISO standards gives the impression that the standards are applicable only to manufacturing.  It appears difficult to apply to clinical processes where patients would be supplies, and the need for clinical judgment is thought of as a deviation from documented practice.  Furthermore, it appears quite likely that ISO-9000 registration in health care would lag other industries for the conceivable future. 

5.3 Malcolm Baldrige National Quality Award (MBNQA) 

The Malcolm Baldrige National Quality Award  (MBNQA) was implemented in 1987 by an act of the US Congress.  Its purpose was to promote awareness and publicize successful quality strategies.  The awards are provided through a joint partnership between the National Institute of Standards and Technology and the private sector.  From their inception, the MBNQA awards have been available to for-profit manufacturing, service companies, or small businesses headquartered in the US. 

Applicants for the award are examined by a panel of external experts who check the organizationís conformance to a series of items within each of category. Emphasis is placed on performance excellence as demonstrated through quantitative data furnished by applicants.  Award winners receive a plaque presented by the President of the United States and are given the right to advertise receipt of the award.  Winners are obligated to share their approach with other firms.  Throughout the years MBNQA award recipients have reported significant improvements in business performance (lower costs, faster turnaround times, higher customer satisfaction) as a result of the quality initiatives implemented under the auspices of the award process.  Publicly traded MBNQA award recipients generally outperform the Standard and Poorís 500 Index (National Institute of Standards and Technology, 1999). 

In 1993, in response to an increased emphasis on quality in health care, a decision was made to develop a pilot program for a Malcolm Baldrige National Quality Award in health care.  The objective of this program was to extend the benefits of the MBNQA program to all health care organizations in the US, including not-for-profit and government owned agencies, while retaining the key criteria developed for the private-sector.  In 1994 and 1995, preliminary analyses were conducted, and test training programs and case study material were developed and piloted.  In 1999, the program was implemented.  The award criteria, known as Health Care Criteria for Performance Excellence, are similar in structure and intent to the business criteria, but differ in sector-specific issues and language.   As related to health care, the seven criteria are: 
1. Leadership. Leadership examines how senior leaders address organizational values, directions, performance expectations, while retaining a focus on patients and other stakeholders, learning, and innovation. 

2. Strategic planning. Strategic planning examines how the organization sets strategic directions, and how it develops strategies and action plans to support the directions. 

3. Focus on patients, other customers, and markets.  This category examines how the organization determines requirements, expectations, and preferences of patients, other customers, and markets. It also examines how the organization builds relationships with patients/customers and determines their satisfaction. 

4. Information and analysis.  The information and analysis category examines the selection, management, and effectiveness of use of information and data to support key organizational processes and action plans, and the organizationís performance management system. 

5. Staff focus.  The staff focus category examines how the organization enables all staff to develop to their full potential. Also examined are the organizationís efforts to build and maintain a work environment and work climate conducive to performance excellence. 

6. Process management.  This category examines the key aspects of process management, including patient/customer-focused design, health care service delivery, support, and supplier relationships and partnering. Emphasis is placed on how key processes are designed, implemented, managed, and improved to achieve better performance. 

7. Organizational performance results.  This category examines the organizationís performance and improvement in key areas patient/customer satisfaction, health care provision, financial and health care marketplace performance, staff and work system results, and operational performance. 

Like the business criteria, the health care criteria do not prescribe a specific methodology or set of tools to use in pursuit of the seven criteria.  The criteria do however give a list of elements within each category that management must consider when conceptualizing a quality system for an organization.  Furthermore, the differentially weighted criteria serve to remind management of the relative importance of the various categories.  For example, a great deal of emphasis 450 out of 1000 possible points  is awarded to the category of performance results.  Like the business criteria, health care awards are made on the basis of a written submission that is judged and evaluated by a blue-ribbon panel of external experts. 

6 Assignment 

The management group of the Department of Anaesthesia has decided that they would like an external opinion from a consultant working in the field of quality management.  Assume that you have been hired by the Head of the Quality Improvement Program to recommend a framework for quality management.  Prepare a recommendation to management.  Justify your decision! 

Use the criteria from the recommended framework to evaluate the initiatives already undertaken by the QIP and highlight areas requiring further development as the QIP moves from quality assurance to quality improvement.