Patient Safety: Integration is Key
By Pat Tydell RN, MSN, MPH
1. To understand the impact of medical errors on patient safety.
2. To understand the Joint Commission's new patient safety standards.
3. To understand the integration process and how it affects infection control and patient safety.
In the mid-1990s the media reported several sensational stories on medical errors. These stories told of innocent patients receiving a 100-fold dose of potentially lethal medications, of wrong limbs being removed or being operated on, and babies being abducted from their hospital cribs. Most of the outcomes from these errors resulted in the death of the patient. In a departure from the usual secrecy and cover-up of practitioners and agencies, the medical establishment slowly began to recognize that errors do indeed occur, with alarming frequency and that they needed to address these errors. A growing group of physicians began to address errors in medicine more publicly. They cited their research that showed that medical errors did occur and more importantly, could be reduced. Medicine organized and supported several private and public organizations whose function was to research medical errors, publish that research and find ways to reduce medical errors.1
As a consequence, the federal government became involved in this aspect of healthcare. In 2000, the Institute of Medicine published its first report on medical errors. It was widely disseminated and quoted.2 In 2001, it published an extensive report on the problems of the US healthcare system and made 13 distinct recommendations for improving the delivery of care.3
The issue of safe patient care is of worldwide concern. Both Australia and the United Kingdom have published studies that demonstrate the same medical errors are occurring in their countries and for similar reasons.4
While the news of medical errors that are catastrophic in nature is highlighted, they provide little to no insight into the nature or magnitude of the problems.4 They provide no solutions and leave the general public scared and confused. The notion that errors will never occur in the delivery of healthcare is not feasible.
There are, however, several disciplines and other industries that have been tapped to provide help with finding solutions. Engineering has proved to have some valuable tools to help in identifying problems in processes and systems and then studying them to determine ways to solve the weakness of the system or at least, minimize its effect. Engineering has examined the work process and the environment itself and provided numerous explanations for how human errors can occur in the work setting. The aviation and nuclear energy industries, which have better records on controlling systems to prevent errors, also have tools and processes that have worked to keep their businesses functioning safely.
Many of these tools and processes are beginning to be discussed and tested in healthcare settings. One of the changes is the reporting of an error when it occurs. Many studies confirm that medical errors are underreported and therefore, HCWs do not have a clear picture of what is actually happening in healthcare facilities. Not only are actual errors not reported, but also those errors that did not cause harm are even less likely to be reported. These near misses are invaluable examples of process and system glitches that may be able to be fixed before they cause actual damage in another situation.1 Along with this, is the recognition that an individual should not be blamed for an error. An error is most likely the result of a series of problems with the process or system of care. No surgeon goes into the operating room and decides that today he will operate on the wrong body part. No nurse decides that she'll give the wrong medication to the wrong patient. These errors were most likely the result of a series of missteps or "holes" in how things are done (the process) in a particular hospital. The stage was set for the doctor's mistake of operating on the wrong body part by the imaging's department lack of accurately and permanently identifying the left and right side of a X-ray film. Or, the OR's unwritten rule that no one questions the surgeon prior to or during a surgical procedure. Or, a myriad of other problems that were too small to be paid attention to or were unknown.
Infection control professionals (ICPs) have had the advantage of years of surveillance and prevention guidelines, as well as regulatory requirements that make patient safety second nature. The control of infections is safe patient care. The steps that infection control practitioners use to assess the environment, design a plan to eliminate a potential hazard, and monitor the effectiveness of that design are the basics for assuring that patients, their families, staff, and others will not be infected by pathogenic organisms.5
Hospital support departments such as engineering, housekeeping, food service, and building maintenance also have been using methods and employing practices that ensure safe patient care. These departments have long-standing histories of guidelines and regulations from the American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE), Environmental Protection Agency (EPA), Centers for Disease Control and Prevention (CDC), National Fire Protection Association (NFPA), Occupational Safety & Health Agency (OSHA), American Institute of Architects (AIA), not to mention state and local regulatory bodies. These agencies continually update their requirements for a safe environment, and routinely consult with healthcare professionals in developing their standards.6
The Joint Commission is the review body that most people who work in healthcare for any length of time recognize as the organization that sets standards and accredits healthcare facilities. Although they are not the only ones, it is the Joint Commission's accreditation that all healthcare facilities seek if they want to receive Medicare reimbursement and continued good standing in the community. The Commission's entry into the medical error reporting and reduction discussions began with the introduction of their sentinel event policy requirement in January, 1996.10 This policy underwent a number of revisions over the last few years. The policy was designed to provide a consistent definition of certain types of medical errors for healthcare organizations to use, a reporting mechanism that is standard throughout the nation, and a process to use when the error occurs to prevent it from happening in the future (root cause analysis).9 Although reporting medical errors that meet the Commission's definitions is voluntary, they have been able to collect enough data from studies submitted to them to be able to publish their sentinel event alerts. These are available on their Web site and offer healthcare facilities everywhere the collective knowledge of others. This is similar to the alerts that the CDC, state, and local health departments have provided to infection control practitioners for many years.
From a few individuals studying medical errors to the current focus on the topic, the attitude of the healthcare industry in this country has begun to change. It is becoming more acceptable to discuss errors and look for ways to prevent their reoccurrence. There are many more private and public organizations that are solely devoted to identifying and correcting errors in-patient care delivery.
Where we're going
The Joint Commission's patient safety standards took effect in July, 2001. These standards require hospitals to initiate specific efforts to prevent medical errors and to tell patients when they have been harmed during their treatment. The changes were primarily concerned with assuring safe patient care. Safe patient care and improving safe patient care are two phrases that can be found in every section of the standards manual. The impact is most noticeable in the leadership chapter. The leadership of the organization is expected to provide resources to implement a patient safety plan with a designated patient care group. The new standards underscore the importance of a strong organization leadership in building a culture of safety. Such a culture should strongly encourage the internal reporting of medical errors, and actively engage clinicians and other staff in the design of remedial steps to prevent future occurrences of these errors.1 Additional emphasis on effective communication, appropriate training, and teamwork found in the standards language were heavily influenced by the both the aviation and healthcare industries.
A second major focus of the new standards is on the prevention of medical errors through the prospective analysis and re-design of high-risk patient care systems such as the ordering, preparation, and dispensing of medications.9 The use of JCAHO's sentinel event database or the hospital's own risk management experience is to be used when determining which system to analyze and re-design.10 Finally, the standards made clear the hospital's responsibility to tell a patient if he or she has been harmed by the care provided.1
The Joint Commission has begun requesting facilities to review and respond to their sentinel event alerts by specific dates. For example, the alert on fires in the home care setting was published in the May, 2001 Perspectives. 'The Joint Commission expected that the organization respond to the suggestions provided by August, 2001. In fact, a recent sentinel event alert (June, 2001) concerned exposure to Creutzfeldt-Jakob (CJD) disease in different hospitals. There were two recommendations that healthcare organizations need to respond to if the recommendations apply to them.10
Along with the new requirements in the leadership chapter, the environment of care chapter also included new requirements. In this area, there is a new standard for worker safety that links to OSHA requirements. This new standard expands the reach of JCAHO from patient safety into staff safety as well. Staff who have responsibility for infection control need to be aware of this standard as it relates to training on general safety, area-specific safety, and job-related hazards. The other changes include a stronger reference to OSHA and the EPA, changes in the emergency management standard and utility management standard.
In the emergency management standard, infection control involvement must be demonstrated in both the plan and the new hazard vulnerability analysis. The Joint Commission is concerned with how an organization anticipates and plans for a disaster. The facility is required to address four phases of emergency management activities. These include:
- Mitigation, or how to minimize the impact of a disaster and the effect of it after it has occurred.
- Preparedness, or the actual written plan to deal with the disaster.
- The response of the organization or drills and evaluation of those drills.
- Recovery, or how you plan to get back to pre-disaster functioning.8
These stages must be department specific. The infection control practitioner's role and involvement in this area is extensive. As an example, planning for the disruption of water involves specific plans for provision of water for patients, staff, handwashing, cooking, dialysis, equipment processing, hydrotherapy, and toilet flushing. The mitigation phase would need to include an estimate of the volume needed for a three-day supply for patients and workers, an assessment of the facility's resources, the surrounding community's resources, and the need for water purification.8 The plan (preparedness phase) would be the written document that outlines these areas for the staff to use. In the response phase, steps for coping with a loss of water would include assessing tap water and obtaining clearance for resuming use, and communicating to staff and patients of water restrictions or of approval to resume use. It would also include inventory and distribution of water plans. In the recovery phase, the process for bringing tap water back into service for safe use would be established.8
Utility management contains new standards that promote a safe, controlled, and comfortable environment of care. These standards are designed to reduce the potential of hospital-acquired illness, assess and minimize the risk of utility failures, and ensure reliability of utility systems. The new standards mandate that the organization manage pathogenic, biological agents in cooling towers, domestic hot water, and other aerosolizing water systems.7 They require the hospital to install and maintain appropriate pressure relationships, air exchange rates, and filtration efficiencies for ventilation systems that serve areas specifically designed to control airborne contaminants like biological agents, gases, fumes, and dust.6 These standards focus on engineering controls even though clean air and fresh water are basic elements of safe patient care. The ICP is expected to be part of the development, monitoring, and revision of policies and procedures that describe how these water and air handling systems are to be managed. By participating in surveillance surveys and environmental rounds, the infection control practitioner can identify environmental deficiencies, hazards, and unsafe practices.
Integration is a must
To integrate means to make whole by bringing all parts together, to unify. The hospital must demonstrate that the various departments and providers link together to delivery safe patient care. How best to do this is simple, yet difficult; innovative, yet traditional. ICPs have been saying for years that infection control is everyone's job. So too is patient safety. No longer can the healthcare setting rely on just a handful of people to provide a safe environment and safe patient care. Healthcare has always been too complex and technical for that approach.
One organizational structure that helps establish and identify links in a facility is a decentralized model. This pushes the authority for activities of whatever process you want out and away from the center to the outlying departments while providing for leadership input and oversight. At a large Midwestern facility, the oversight body is the quality council, while each functional subcommittee is one of the chapters identified by JCAHO. The infection control subcommittee comprises members who meet regularly and are chartered by the quality council. This charter provides the committee with the authority and responsibility to conduct their infection control surveillance, prevention, and control activities in the hospital, outpatient clinics, and community settings. The committee reports regularly to the council and makes referrals and recommendations as necessary. The infection control practitioner is, in turn, a member of other functional subcommittees' i.e., environment of care subcommittee. This shows the linkage between infection control activities and environment of care activities. As a member of the subcommittee, the ICP attends environmental rounds done on all buildings and clinics and has input into the education of staff. This arrangement allows for the ICP to be present at meetings and rounds when items such as utility management is discussed. As part of the environment of care, the ICP will be involved in all of the environmental issues. These include preventive maintenance, engineering controls, medical waste, and construction and renovation. With the new patient safety standards, the ICP will be a member of the patient safety subcommittee also. This subcommittee comprises persons from engineering, police/security, housekeeping, employee health, human resources, as well as clinically oriented professionals (doctors, pharmacists). Through attendance at meetings, participation in activities, and input into policies, the ICP can show how infection control is integrated into the newer areas of safe patient care.
One of the problems identified with all of this integration is the possibility of overlapping roles and activities. When there are not clearly defined functions, the staff is likely to get confused as to who is responsible for what. Written descriptions of responsibilities and roles must be developed and reviewed to maintain clarity of roles and incorporate changes as they occur. When the organization writes down their standard operating procedures, then areas such as communication (who communicates what to whom and when) can be identified and used as a go-by. Doing this may show that the organization is more integrated than they believed. This also helps external reviewers understand the system. In turn, outside reviewers can more easily determine if regulations are being met.
Communication lines need to be written so that reporting schedules can be set up and followed. In the decentralized model, a quarterly to monthly reporting schedule can be initiated to communicate with the leadership oversight group and other departments of the hospital.
The goal of all of these patient safety standards is to improve the safe delivery of patient care. Therefore, the organization must demonstrate how they have improved the care. The facility can conduct a root cause analysis on a high-risk process of care i.e., medication administration. The facility then evaluates the new system using the failure mode, effect, and criticality analysis to identify any problems in the system and correct them before they cause harm. The organization monitors the new process to establish that the new process actually reduced the number of errors related to medication administration. With an integrated model, the communication of the improvement in this activity of patient care is more easily accomplished and highlights once more the necessity for integrating roles and functions.
The new patient safety standards require that the organization demonstrate a culture of safety. The facility must show how all practitioners who have direct patient care responsibilities and all support services work together to make the care of patients safe or improve it. Drawing from disciplines such as engineering and industries such as aviation to re-design processes and systems, the healthcare organization will need to learn how to best use this other tools. Applying them to the care of patients to improve the outcomes will be challenging. More is expected of the providers, support staff and management than just doing their job. The organization needs to demonstrate that patient safety is everyone's job.
Pat Tydell, RN, MSN, MPH, is the risk manager at North Chicago Veterans Administration Medical Center (VAMC) in North Chicago, Ill.
|Exam Questions: True or False
1. The focus on patient safety gained national attention in the country in the mid-1990s.
2. Since the mid-1990s, the healthcare industry has been slow to respond to these issues.
3. Patient safety issues are global in scope.
4. The Institute of Medicine (IOM), published two articles on patient safety in this country, one with specific recommendations.
5. The healthcare industry has looked to and borrowed tools for improving the delivery of care from engineering and aviation.
6. One of these tools, root cause analysis, has been incorporated into the Joint Commission's standards on sentinel events.
7. Infection control practitioners have the advantage of being in a better position to meet the new patient safety requirements because of historical practices and regulations.
8. Joint Commission's new patient safety standards focus responsibility for their implementation only on the leadership group of an organization.
9. The patient safety standards are designed to eliminate error in healthcare delivery.
10. The second major focus of the new standards is the prevention of medical errors through prospective analysis and re-design of high risk patient care systems.
11. Hospitals must now respond within a specific timeframe to the Joint's sentinel event alerts.
12. The environment of care links various regulatory bodies such as OSHA together.
13. Infection control has little input into the emergency management plan of the hospital because it is an engineering activity.
14. Assuring safe water and air supply for patient care falls to the support services of a hospital exclusively.
15. A working definition of integration would be to bring all parts of the healthcare organization together to meet the common goal of providing safe, effective patient care.
16. One model that helps assure that integration is happening throughout the healthcare organization is the centralization of all positions and activities under one leader.
17. Demonstrating the linking of infection control involvement in various aspects of patient care requires documentation of those activities and communications.
18. A potential problem of integration is overlapping roles and responsibilities resulting in confusion for the staff.
19. A written plan delineating roles, responsibilities, and communication lines can help the organization show external reviewers how the integrate various functions of patient care.
20. The outcome of these time-consuming activities is to improve the delivery of safe patient care in our hospitals and clinics.
|"Patient Safety: Integration is the Key,"
by Pat Tydell, RN, MSN, MPH
2. National Academy Press. To err is human: building a safer health system. Institute of Medicine. 2000.
3. National Academy Press. Crossing the quality chasm. Institute of Medicine. 2001.
5. Patterson, Carol H. Engineering Controls vs. Infection Control. Nursing Management June, 2001.
6. icanMD. Air Quality. ican. Inc. 2001.
7. icanMD. Safe Water. ican, Inc. 2001.
8. icanMD. Phases of disaster planning and response. ican, Inc. 2001.
9. Joint Commission on Accreditation of Healthcare. Comprehensive Accreditation Manual for Hospitals. 2001.
10. Joint Commission on Accreditation of Healthcare. Sentinel Event Alert- Exposure to Creutzfeldt-Jakob Disease. www.jcaho.org/edu.