Patient safety and quality improvement

Published on 07/02/2015 by admin

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Patient safety and quality improvement

Karl A. Poterack, MD

Although patient safety and quality improvement (QI) have been priorities for health care institutions for some time, it was the 2006 report of the Institute of Medicine highlighting the morbidity and mortality risks associated with iatrogenic injury in hospitals that captured the public’s interest. Although the report has many problems, the chief executive officers of Fortune 500 companies and third-party payers found the report to be in keeping with their thoughts on the health care industry: reimbursement for health care was increasing at double-digit rates every year, but outcomes were no better, and days of work lost due to illness were not decreasing. Accordingly, over the last several years, QI and the safety of patients in health care institutions has garnered more publicity and increased emphasis on safety.

Quality improvement

QI is a strategy to guide individual and group decision making. It has its roots in engineering and manufacturing, where systems theory and statistical process control were combined with general management methods. It is variously defined as the reduction of variability in products and processes and as an organized process that assesses and evaluates health services to improve practice or quality of care. International Organization for Standardization (ISO) standard 8402-1986 defines quality as “the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.” The Institute of Medicine defines health care quality as “the extent to which health services provided to individuals and patient populations improve desired health outcomes.” W. Edwards Deming defined quality as “meeting customer requirements at a price they are willing to pay.”

QI programs in anesthesiology are guided by requirements of regulatory bodies, such as state law, Center for Medicare Services, and The Joint Commission. Unfortunately, many clinicians view QI programs as being driven solely by mandates of these external regulatory groups, which results in the whole system being perceived as “red tape” and “overhead” that add cost but no real value. Such an approach can easily become a self-fulfilling prophecy by consuming resources through the production of unread reports and paperwork, thus diverting resources that could be devoted to actually increasing quality.

Different elements of a QI program may focus on the structure, process, and outcome of health care delivery programs. Structure refers to the setting in which care is provided, (e.g., personnel, facilities, and how they are organized); process, to the patient care activities that are performed; and outcome, to any changes in the patient’s health after the care was performed. QI programs, therefore, address all areas of hospital operations. An adverse event then, is an untoward, undesirable, and usually unanticipated event, such as the death of a patient, but also of an employee or a visitor in a health care organization. Incidents such as patient falls or improper administration of medications are also considered to be adverse events even if the event has no permanent effect on the patient. A medical error is an adverse event or near miss that is preventable with the current state of medical knowledge, and a sentinel event is a single isolated event that may indicate a systems problem.

The Joint Commission defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase ‘or the risk thereof’ includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.” The Joint Commission requires all sentinel events to undergo root-cause analysis. In this analysis, the stakeholders who were involved in the care of the affected patient at the hospital in which the sentinel event occurred analyze the events to identify flaws in the system process.

Continuous QI views patient care as a complex system in which undesired results occur because of either a random or a system error. The default assumption is that errors are systems-based until proved otherwise. System errors should be controllable through changing the system. These systems problems (“opportunities for improvement”) are identified on an ongoing basis, and strategies are implemented to prevent their occurrence.

Identifying these opportunities for improvement may occur in one of several ways. A common method of identification, mandated by regulatory bodies and with a long history of use in medicine, is to focus on undesirable outcomes—the mortality and morbidity method. In contrast with the shame, blame, and scapegoating of many traditional mortality and morbidity processes, continuous QI focuses not on blame, but, rather, on identification of the system causes of undesirable outcomes. A second way of identifying areas of improvement is the suggestion box method—giving the opportunity to those actually involved in the process to identify problems and suggest solutions. This method may range from planned gatherings at various intervals to specifically gather input, to a very informal open-door policy that fosters and encourages input from those on the front line. A third category is through the systematic measurement of predefined indicators of quality, such as wait times, turnover times, materials waste, and rates of adverse outcomes.

Once specific opportunities for improvement are identified, their current status is measured. The process of care leading to these problems is analyzed. Although the proper way to perform this analysis varies widely, several key points apply to all of them: (1) all areas involved in the actual process (the stakeholders) need to be involved in the analysis, (2) the analysis must be as detailed as possible, (3) the temptation to jump to conclusions must be resisted (“if only the residents would correctly fill out the paperwork, we wouldn’t have a problem”), and (4) the goal is to change the system to facilitate the desired outcome.

If change is identified that should lead to improvement, it is implemented. After an appropriate time period, the status is measured again to determine whether improvement actually occurred. Attention may then be directed to continuing to improve this process or turning to a different process to target for improvement.

Medication errors, assessment, and prevention

A common focus of QI programs is the prevention of medication errors. An adverse drug event refers to any incident in which the use of a medication (drug or biologic) at any dose, a medical device, or a special nutritional product (e.g., dietary supplement, infant formula, medical food) may have resulted in an adverse outcome in a patient. An adverse drug reaction, on the other hand, is an undesirable response associated with use of a drug that compromises therapeutic efficacy, enhances toxicity, or both. The aforementioned Institute of Medicine report identified medication errors as the most common type of error in health care and attributed several thousand deaths to medication-related events.

Numerous organizations have published recommendations for the prevention of medication errors, including, for example, the Agency for Healthcare Research and Quality, the Institute for Healthcare Improvement, the Institute for Safe Medication Practices, The Joint Commission, and the National Quality Forum. These recommendations include implementing computerized provider order entry, using barcoding technology at the point of care, ensuring availability of pharmaceutical decision support, having a central pharmacist supply high-risk intravenously administered medications and pharmacy-based admixture systems, standardizing prescription writing and prescription rules, and eliminating certain abbreviations and dose expressions.

Programs to improve outcome

Medication errors can occur anywhere in the hospital. QI efforts that are focused on the operating room, in which anesthesia providers are very involved, include efforts to decrease surgical wound infections and bloodstream infections. For the former, the administration of prophylactic antibiotics, maintenance of normothermia, and more judicious use of fluids and of vasoactive agents are becoming increasingly regulated and monitored. Both the Centers for Disease Control and Prevention and the American Society of Anesthesiologists have promulgated clinical practice guidelines for the placement of central venous catheters. The administration of β-adrenergic receptor blocking agents on the day of surgery to patients who have been taking them is also the focus of many QI programs, and monitored by The Joint Commission. These programs are not static. As part of the QI initiative, the processes are monitored; compliance with the recommendations, systems’ problems in implementing the recommendations, and the outcomes themselves must be monitored and assessed, and changes to the recommendations must be implemented when necessary.

Disclosure of errors to patients

Not necessarily part of the QI process, one of the areas that has come under increased scrutiny in the last several years concerns how and what to reveal to patients and their family members when errors are discovered. Fear of malpractice action has traditionally made physicians hesitant to disclose medical errors to patients. However, regulatory bodies now encourage, and in some cases state law may require, the disclosure of “serious unanticipated outcomes” to patients. Such disclosure is frequently not protected from admissibility in a legal action. Surveys suggest that most patients want disclosure of errors, an explanation of how the error occurred and how the effects of the error will be minimized, and what actions will be taken to prevent the error from occurring to other patients. Most hospitals and medical staffs, with input from their legal departments, have developed guidelines on how errors and adverse events are disclosed to patients and their families.

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Patient safety and quality improvement

Karl A. Poterack, MD

Although patient safety and quality improvement (QI) have been priorities for health care institutions for some time, it was the 2006 report of the Institute of Medicine highlighting the morbidity and mortality risks associated with iatrogenic injury in hospitals that captured the public’s interest. Although the report has many problems, the chief executive officers of Fortune 500 companies and third-party payers found the report to be in keeping with their thoughts on the health care industry: reimbursement for health care was increasing at double-digit rates every year, but outcomes were no better, and days of work lost due to illness were not decreasing. Accordingly, over the last several years, QI and the safety of patients in health care institutions has garnered more publicity and increased emphasis on safety.

Quality improvement

QI is a strategy to guide individual and group decision making. It has its roots in engineering and manufacturing, where systems theory and statistical process control were combined with general management methods. It is variously defined as the reduction of variability in products and processes and as an organized process that assesses and evaluates health services to improve practice or quality of care. International Organization for Standardization (ISO) standard 8402-1986 defines quality as “the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.” The Institute of Medicine defines health care quality as “the extent to which health services provided to individuals and patient populations improve desired health outcomes.” W. Edwards Deming defined quality as “meeting customer requirements at a price they are willing to pay.”

QI programs in anesthesiology are guided by requirements of regulatory bodies, such as state law, Center for Medicare Services, and The Joint Commission. Unfortunately, many clinicians view QI programs as being driven solely by mandates of these external regulatory groups, which results in the whole system being perceived as “red tape” and “overhead” that add cost but no real value. Such an approach can easily become a self-fulfilling prophecy by consuming resources through the production of unread reports and paperwork, thus diverting resources that could be devoted to actually increasing quality.

Different elements of a QI program may focus on the structure, process, and outcome of health care delivery programs. Structure refers to the setting in which care is provided, (e.g., personnel, facilities, and how they are organized); process, to the patient care activities that are performed; and outcome, to any changes in the patient’s health after the care was performed. QI programs, therefore, address all areas of hospital operations. An adverse event then, is an untoward, undesirable, and usually unanticipated event, such as the death of a patient, but also of an employee or a visitor in a health care organization. Incidents such as patient falls or improper administration of medications are also considered to be adverse events even if the event has no permanent effect on the patient. A medical error is an adverse event or near miss that is preventable with the current state of medical knowledge, and a sentinel event is a single isolated event that may indicate a systems problem.

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