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 medicalerrors. These stories told of innocent patients receiving a 100-fold dose ofpotentially lethal medications, of wrong limbs being removed or being operatedon, and babies being abducted from their hospital cribs. Most of the outcomesfrom these errors resulted in the death of the patient. In a departure from theusual secrecy and cover-up of practitioners and agencies, the medicalestablishment slowly began to recognize that errors do indeed occur, withalarming frequency and that they needed to address these errors. A growing groupof physicians began to address errors in medicine more publicly. They citedtheir research that showed that medical errors did occur and more importantly,could be reduced. Medicine organized and supported several private and publicorganizations whose function was to research medical errors, publish thatresearch and find ways to reduce medical errors.1
As a consequence, the federal government became involved in this aspect ofhealthcare. In 2000, the Institute of Medicine published its first report onmedical errors. It was widely disseminated and quoted.2 In 2001, itpublished an extensive report on the problems of the US healthcare system andmade 13 distinct recommendations for improving the delivery of care.3
The issue of safe patient care is of worldwide concern. Both Australia andthe United Kingdom have published studies that demonstrate the same medicalerrors are occurring in their countries and for similar reasons.4
While the news of medical errors that are catastrophic in nature ishighlighted, they provide little to no insight into the nature or magnitude ofthe problems.4 They provide no solutions and leave the general publicscared and confused. The notion that errors will never occur in the delivery ofhealthcare is not feasible.
There are, however, several disciplines and other industries that have beentapped to provide help with finding solutions. Engineering has proved to havesome valuable tools to help in identifying problems in processes and systems andthen studying them to determine ways to solve the weakness of the system or atleast, minimize its effect. Engineering has examined the work process and theenvironment itself and provided numerous explanations for how human errors canoccur in the work setting. The aviation and nuclear energy industries, whichhave better records on controlling systems to prevent errors, also have toolsand processes that have worked to keep their businesses functioning safely.
Many of these tools and processes are beginning to be discussed and tested inhealthcare settings. One of the changes is the reporting of an error when itoccurs. Many studies confirm that medical errors are underreported andtherefore, HCWs do not have a clear picture of what is actually happening inhealthcare facilities. Not only are actual errors not reported, but also thoseerrors that did not cause harm are even less likely to be reported. These nearmisses are invaluable examples of process and system glitches that may be ableto be fixed before they cause actual damage in another situation.1Along with this, is the recognition that an individual should not be blamed foran error. An error is most likely the result of a series of problems with theprocess or system of care. No surgeon goes into the operating room and decidesthat today he will operate on the wrong body part. No nurse decides that she'llgive the wrong medication to the wrong patient. These errors were most likelythe 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'smistake of operating on the wrong body part by the imaging's department lack ofaccurately 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 duringa surgical procedure. Or, a myriad of other problems that were too small to bepaid attention to or were unknown.
Infection control professionals (ICPs) have had the advantage of years ofsurveillance and prevention guidelines, as well as regulatory requirements thatmake patient safety second nature. The control of infections is safe patientcare. The steps that infection control practitioners use to assess theenvironment, design a plan to eliminate a potential hazard, and monitor theeffectiveness of that design are the basics for assuring that patients, theirfamilies, 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 practicesthat ensure safe patient care. These departments have long-standing histories ofguidelines 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 ProtectionAssociation (NFPA), Occupational Safety & Health Agency (OSHA), AmericanInstitute of Architects (AIA), not to mention state and local regulatory bodies.These agencies continually update their requirements for a safe environment, androutinely consult with healthcare professionals in developing their standards.6
The Joint Commission is the review body that most people who work inhealthcare for any length of time recognize as the organization that setsstandards and accredits healthcare facilities. Although they are not the onlyones, it is the Joint Commission's accreditation that all healthcare facilitiesseek if they want to receive Medicare reimbursement and continued good standingin the community. The Commission's entry into the medical error reporting andreduction discussions began with the introduction of their sentinel event policyrequirement in January, 1996.10 This policy underwent a number ofrevisions over the last few years. The policy was designed to provide aconsistent definition of certain types of medical errors for healthcareorganizations to use, a reporting mechanism that is standard throughout thenation, and a process to use when the error occurs to prevent it from happeningin the future (root cause analysis).9 Although reporting medicalerrors that meet the Commission's definitions is voluntary, they have been ableto collect enough data from studies submitted to them to be able to publishtheir sentinel event alerts. These are available on their Web site and offerhealthcare facilities everywhere the collective knowledge of others. This issimilar to the alerts that the CDC, state, and local health departments haveprovided to infection control practitioners for many years.
From a few individuals studying medical errors to the current focus on thetopic, the attitude of the healthcare industry in this country has begun tochange. It is becoming more acceptable to discuss errors and look for ways toprevent their reoccurrence. There are many more private and public organizationsthat are solely devoted to identifying and correcting errors in-patient caredelivery.
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 preventmedical errors and to tell patients when they have been harmed during theirtreatment. The changes were primarily concerned with assuring safe patient care.Safe patient care and improving safe patient care are two phrases that can befound in every section of the standards manual. The impact is most noticeable inthe leadership chapter. The leadership of the organization is expected toprovide resources to implement a patient safety plan with a designated patientcare group. The new standards underscore the importance of a strong organizationleadership in building a culture of safety. Such a culture should stronglyencourage the internal reporting of medical errors, and actively engageclinicians and other staff in the design of remedial steps to prevent futureoccurrences of these errors.1 Additional emphasis on effectivecommunication, appropriate training, and teamwork found in the standardslanguage were heavily influenced by the both the aviation and healthcareindustries.
A second major focus of the new standards is on the prevention of medicalerrors through the prospective analysis and re-design of high-risk patient caresystems such as the ordering, preparation, and dispensing of medications.9The use of JCAHO's sentinel event database or the hospital's own risk managementexperience is to be used when determining which system to analyze and re-design.10Finally, the standards made clear the hospital's responsibility to tell apatient if he or she has been harmed by the care provided.1
The Joint Commission has begun requesting facilities to review and respond totheir sentinel event alerts by specific dates. For example, the alert on firesin the home care setting was published in the May, 2001 Perspectives.'The Joint Commission expected that the organization respond to the suggestionsprovided 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 toif the recommendations apply to them.10
Along with the new requirements in the leadership chapter, the environment ofcare chapter also included new requirements. In this area, there is a newstandard for worker safety that links to OSHA requirements. This new standardexpands the reach of JCAHO from patient safety into staff safety as well. Staffwho have responsibility for infection control need to be aware of this standardas it relates to training on general safety, area-specific safety, andjob-related hazards. The other changes include a stronger reference to OSHA andthe EPA, changes in the emergency management standard and utility managementstandard.
In the emergency management standard, infection control involvement must bedemonstrated in both the plan and the new hazard vulnerability analysis. TheJoint Commission is concerned with how an organization anticipates and plans fora disaster. The facility is required to address four phases of emergencymanagement activities. These include:
These stages must be department specific. The infection controlpractitioner's role and involvement in this area is extensive. As an example,planning for the disruption of water involves specific plans for provision ofwater for patients, staff, handwashing, cooking, dialysis, equipment processing,hydrotherapy, and toilet flushing. The mitigation phase would need to include anestimate of the volume needed for a three-day supply for patients and workers,an assessment of the facility's resources, the surrounding community'sresources, and the need for water purification.8 The plan(preparedness phase) would be the written document that outlines these areas forthe staff to use. In the response phase, steps for coping with a loss of waterwould include assessing tap water and obtaining clearance for resuming use, andcommunicating to staff and patients of water restrictions or of approval toresume use. It would also include inventory and distribution of water plans. Inthe recovery phase, the process for bringing tap water back into service forsafe 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 thepotential of hospital-acquired illness, assess and minimize the risk of utilityfailures, and ensure reliability of utility systems. The new standards mandatethat the organization manage pathogenic, biological agents in cooling towers,domestic hot water, and other aerosolizing water systems.7 Theyrequire the hospital to install and maintain appropriate pressure relationships,air exchange rates, and filtration efficiencies for ventilation systems thatserve areas specifically designed to control airborne contaminants likebiological agents, gases, fumes, and dust.6 These standards focus onengineering controls even though clean air and fresh water are basic elements ofsafe patient care. The ICP is expected to be part of the development,monitoring, and revision of policies and procedures that describe how thesewater and air handling systems are to be managed. By participating insurveillance surveys and environmental rounds, the infection controlpractitioner can identify environmental deficiencies, hazards, and unsafepractices.
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 linktogether to delivery safe patient care. How best to do this is simple, yetdifficult; innovative, yet traditional. ICPs have been saying for years thatinfection control is everyone's job. So too is patient safety. No longer can thehealthcare setting rely on just a handful of people to provide a safeenvironment and safe patient care. Healthcare has always been too complex andtechnical for that approach.
One organizational structure that helps establish and identify links in afacility is a decentralized model. This pushes the authority for activities ofwhatever process you want out and away from the center to the outlyingdepartments while providing for leadership input and oversight. At a largeMidwestern facility, the oversight body is the quality council, while eachfunctional subcommittee is one of the chapters identified by JCAHO. Theinfection control subcommittee comprises members who meet regularly and arechartered by the quality council. This charter provides the committee with theauthority and responsibility to conduct their infection control surveillance,prevention, and control activities in the hospital, outpatient clinics, andcommunity settings. The committee reports regularly to the council and makesreferrals and recommendations as necessary. The infection control practitioneris, in turn, a member of other functional subcommittees' i.e.,environment of care subcommittee. This shows the linkage between infectioncontrol activities and environment of care activities. As a member of thesubcommittee, the ICP attends environmental rounds done on all buildings andclinics and has input into the education of staff. This arrangement allows forthe ICP to be present at meetings and rounds when items such as utilitymanagement is discussed. As part of the environment of care, the ICP will beinvolved in all of the environmental issues. These include preventivemaintenance, engineering controls, medical waste, and construction andrenovation. With the new patient safety standards, the ICP will be a member ofthe patient safety subcommittee also. This subcommittee comprises persons fromengineering, police/security, housekeeping, employee health, human resources, aswell as clinically oriented professionals (doctors, pharmacists). Throughattendance at meetings, participation in activities, and input into policies,the ICP can show how infection control is integrated into the newer areas ofsafe patient care.
One of the problems identified with all of this integration is thepossibility of overlapping roles and activities. When there are not clearlydefined functions, the staff is likely to get confused as to who is responsiblefor what. Written descriptions of responsibilities and roles must be developedand reviewed to maintain clarity of roles and incorporate changes as they occur.When the organization writes down their standard operating procedures, thenareas such as communication (who communicates what to whom and when) can beidentified and used as a go-by. Doing this may show that the organization ismore integrated than they believed. This also helps external reviewersunderstand the system. In turn, outside reviewers can more easily determine ifregulations are being met.
Communication lines need to be written so that reporting schedules can be setup and followed. In the decentralized model, a quarterly to monthly reportingschedule can be initiated to communicate with the leadership oversight group andother departments of the hospital.
The goal of all of these patient safety standards is to improve the safedelivery of patient care. Therefore, the organization must demonstrate how theyhave improved the care. The facility can conduct a root cause analysis on ahigh-risk process of care i.e., medication administration. The facilitythen evaluates the new system using the failure mode, effect, and criticalityanalysis to identify any problems in the system and correct them before theycause harm. The organization monitors the new process to establish that the newprocess actually reduced the number of errors related to medicationadministration. With an integrated model, the communication of the improvementin this activity of patient care is more easily accomplished and highlights oncemore the necessity for integrating roles and functions.
The new patient safety standards require that the organization demonstrate aculture of safety. The facility must show how all practitioners who have directpatient care responsibilities and all support services work together to make thecare of patients safe or improve it. Drawing from disciplines such asengineering 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 bechallenging. More is expected of the providers, support staff and managementthan just doing their job. The organization needs to demonstrate that patientsafety is everyone's job.
Pat Tydell, RN, MSN, MPH, is the risk manager at North Chicago VeteransAdministration Medical Center (VAMC) in North Chicago, Ill.
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.
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.