A: The Department of Veterans Affairs (VA) National Center for Patient Safety (NCPS) was established in 1999 to lead the VA's patient safety efforts and to develop and nurture a culture of safety throughout the Veterans Health Administration (VHA). NCPS' primary goal is the nationwide reduction and prevention of inadvertent harm to patients as a result of their care.

A: NCPS represents a unified and cohesive patient safety program. All 158 VA hospitals actively participate in the program and it is supported by dedicated patient safety managers. Our multi-disciplinary headquarters staff is located in Ann Arbor, MI, Washington, D.C., and White River Junction, Vt., and offers expertise on an array of patient safety and related health care issues and initiatives.

A: Our program is unique in healthcare because we use a "systems approach" to develop health care solutions based on prevention, not punishment. We use Human Factors Engineering methods and apply ideas from "high reliability" organizations, such as aviation and nuclear power, to target and eliminate system vulnerabilities.

A: Human Factors Engineering is the study of designs that are "human-centered." Such designs support or can enhance a person's performance. This is in contrast to designs that force the user to stretch or to make an extra effort to interact successfully with an interface or device. Dangerous devices may trick or mislead users into an unintentional error.

A: By taking a systems approach to problem solving, and keeping professional identities confidential, no one is blamed and problems can be thoroughly investigated. We believe that people come to work to do a good job - not to do a bad job. Given the right set of circumstances, any of us can make a mistake. We must force ourselves to look past the easy answer - that the adverse event was someone's fault. We look at the tougher question: Why did this adverse event occur? It is seldom for a single reason. A chain of events that has gone unnoticed most often leads to a recurring safety problem, regardless of the personnel involved.

A: No. Other high-risk industries, such as the airline and nuclear power industries, have used this approach for years to enhance safety and reduce system vulnerabilities. We continue to look for new ways to adapt the systems approach to health care.

A: NCPS uses a multi-disciplinary team approach, known as Root Cause Analysis (RCA), to study health care-related adverse events and close calls. The goal of the RCA process is to find out what happened, why it happened and to determine what can be done to prevent it from happening again.

A: Close calls are events or situations that could have resulted in a patient's accident or injury, but didn't, either by chance or by timely intervention. Such events have also been referred to as near miss incidents.

A: Because people on the frontline are usually in the best position to identify issues and solutions, RCA teams at each of the VA health care facilities formulate solutions, test, implement, and measure outcomes in order to improve patient safety. De-identified, aggregated findings from the teams are shared nationwide if there is a clear benefit for multiple facilities. Through understanding the real underlying causes of a system's vulnerability, we can better position ourselves to prevent future occurrences.

A: These are findings that have been grouped together by category and have had all personal and facility names, facility locations, and other potentially identifying information removed.

A: Yes. One example is the Health Care Failure Mode and Effects Analysis (HFMEA ä ) program. HFMEA ä is a five-step process that uses an interdisciplinary team approach to proactively evaluate a health care process . Designed by NCPS specifically for health care, the method uses analytical tools, such as flow diagramming, decision trees, and prioritized scoring systems to identify and assess potential vulnerabilities in a specific heath care process.  

A: Yes. The innovative Patient Safety Reporting System (PSRS) was jointly developed by the VHA and the National Aeronautics and Space Administration (NASA). It is a voluntary, external, non-punitive "learning program" available to all VA employees.

PSRS provides VA employees a "safety valve" to confidentially report adverse events or close calls that, for whatever reason, wouldn't be reported elsewhere.

All personal and facility names, facility locations, and other potentially identifying information are removed before reports are entered into the PSRS database. Only NASA personnel assigned to the reporting system can review data until the de-identification process is complete.

A: The Veterans Health Administration (VHA) currently has two systems in place for reporting medical adverse events and close calls. One system is the internal, confidential and non-punitive Patient Safety Information System. This system was implemented and is run by the VA National Center for Patient Safety (NCPS). This adverse event and close call reporting and analysis system electronically documents and monitors patient safety information throughout VHA. Using tools developed by NCPS, multidisciplinary teams from VHA facilities conduct thorough root cause analyses of these events. Corrective actions are then planned and implemented and follow up actions are used to determine if the corrective actions implemented are successful.

The other reporting system in the VHA is the Patient Safety Reporting System (PSRS). (Please see next question for more detail.)

A: PSRS is an external voluntary system that was jointly developed by VHA and the National Aeronautics and Space Administration (NASA) and is designed to be complementary to VHA's internal reporting system. PSRS is designed to identify broad system vulnerabilities and act as a "safety valve" for the reporting of events that otherwise would not be reported to the internal system. This voluntary, confidential and non-punitive program is available to all VA employees for the reporting of events and concerns related to patient safety.

A: No. We have also developed an internal, confidential, non-punitive reporting method: the Patient Safety Information System, called "SPOT." The SPOT reporting and analysis system electronically documents and monitors patient safety information throughout the VHA so that corrective action may be taken. Using tools developed by NCPS, multidisciplinary teams from VHA facilities conduct a thorough Root Cause Analysis of adverse events. Corrective actions are then planned and implemented. Follow-up actions are used to determine if the corrective actions implemented were successful.

A: Reports in medical literature indicate that as many as 180,000 deaths occur in the United States each year due to errors in medical care, many of which are preventable. The mission of NCPS is to reduce adverse medical events throughout the VA's health care system, the largest health care system in the nation. At the core of our efforts is the development of what we call a culture of safety .

A: Our definition of a culture of safety is founded on a systems approach to developing health care solutions based on prevention, not punishment . Creating a culture of safety means moving beyond a culture of blame to one of "safety mindfulness." We believe that people come to work to do a good job - not to do a bad job. Given the right set of circumstances, any of us can make a mistake. We must force ourselves to look past the easy answer - that an adverse event was someone's fault. We want to look at the tougher question: Why did this adverse event occur? It is seldom for a single reason. A chain of events that has gone unnoticed most often leads to a recurring safety problem, regardless of the personnel involved.

A: We receive reports of all types; there is no "typical" report.

A: A surgical or other procedure almost performed on the wrong patient due to a lapse in verification of patient identification, but caught at the last minute by chance or intervention, with no harm done to the patient.  

A: Close calls are important opportunities for learning and afford the chance to develop preventive strategies and actions. Close calls receive the same level of scrutiny as adverse events that result in actual injuries. Close calls can provide an accurate picture of what actually occurs in an organization and have been shown to be anywhere from 100 to 300 times more common than actual adverse events.

A: We take a systems approach to reviewing the data we receive from the field. We look for system vulnerabilities, rather than focusing on counting how may problems occurred during a specific time frame. We ask ourselves why a specific problem has occurred and develop safety advisories and alerts that are of a sufficiently high priority to provide our patient safety managers with a solution.

A: No. Experience can be one of the most costly and painful teachers. We want to learn how to avoid problems before they happen, rather than have patients suffer from mistakes . One of the best ways to reduce medical errors is to study a close call and to create a system to ensure the same problem is less likely to recur. A close call is where something almost goes wrong, but no harm is done. Establishing a culture of safety where people are able to report both adverse events and close calls without fear of punishment is the key to enhancing patient safety and avoiding future problems. You can't fix what you don't know about.

A: All medical procedures involve risk. Our systems approach to health care solutions is designed to reduce the risk to a minimum.  

A: Adverse events are untoward incidents directly associated with care or services provided within the jurisdiction of a VA medical center, outpatient clinic or other facility.

Adverse events may result from a wide range of acts of commission or omission. An event could be caused by administering the wrong medication or failing to make a timely diagnosis. Some examples of more common adverse events include patient falls or medication or procedural errors.

A: Sentinel events are a type of adverse event. Sentinel events, as defined by the Joint Commission, are unexpected occurrences involving death or serious physical or psychological injury, or risk thereof. Serious injury specifically includes loss of limb or function. Major permanent loss of function means sensory, motor, physiologic, or intellectual impairment not previously present that requires continued treatment or life-style change.

A: No. We have a system that delineates what type of activities may result in blame and which don't. Only those events that are judged to be an intentionally unsafe act can result in the assignment of blame and punitive action.

A: Intentional unsafe acts, as they pertain to patients, are any events that result from a criminal act, a purposefully unsafe act, or an act related to alcohol or substance abuse or patient abuse.

A: A design that is "human-centered" supports or even enhances human performance. The opposite is a design that forces the user to stretch or to make an extra effort to interact successfully with an interface or device. Dangerous devices may trip users into an unintentional error.

Usability is a measure of the design's success to support or enhance human performance. The best sort of human-centered devices are easy to use, friendly and intuitively understood. With regard to patient safety, the best devices and interfaces are produced in accordance with the principles of human-centered design and pass usability testing before implementation.

A: Yes. The NCPS program was tested then implemented throughout the VA system from Nov. 1999 to Aug. 2000. Program components included an RCA system for use by frontline caregivers, a system for the aggregate review of RCA results, information systems software, safety alerts and advisories, and cognitive aides. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls, reflecting the level of commitment to the program by VHA leaders and staff. The importance of this approach to health care earned NCPS the prestigious Innovations in American Government Award, 2001.

A: Yes. Many national and international healthcare leaders have attended our patient safety training programs (when capacity allows, based on the number of VA employees attending). Participants have come from organizations such as: the Department of Defense, the American Hospital Association and the American College of Surgeons. Representatives from Australia, Canada, Denmark, Hong Kong, Japan, Singapore, New Zealand and Sweden have also attended these classes.

A: Yes . The American Hospital Association recently produced and distributed to its member hospitals and health systems, "Strategies for Leadership: A Toolkit for Improving Patient Safety." Although the materials included in the toolkit were developed by NCPS, the toolkit is only available from AHA.

A: The VA health system is recognized as a national leader in health care, rated by the Institute of Medicine as "the best in the nation," Oct. 2002. VA's achievements include the application of information management technology through development and widespread use of a computerized medical record system and the Bar Code Medication Administration program.

A: The VA health care system includes 158 hospitals, with at least one in each of the 48 contiguous states, Puerto Rico and the District of Columbia. The VA operates more than 850 ambulatory care and community-based outpatient clinics, 137 nursing homes, 43 domiciliaries and 73 comprehensive home-care programs. VA health care facilities provide a broad spectrum of medical, surgical and rehabilitative care.

The VA has experienced unprecedented growth in the medical system workload over the past few years. The total number of patients treated increased by over 11 percent from 2000 to 2001 -- more than twice the prior year's rate of growth.

More than 4.2 million people received care in VA health care facilities in 2001. The VA is used annually by approximately 75 percent of all disabled and low-income veterans. In 2001, the VA treated about 587,000 patients in VA hospitals and contract hospitals, 87,000 in nursing homes and 45,000 in domiciliaries. The VA's outpatient clinics registered approximately 42.9 million visits.

A: The reason can be: 1) the diagnosis, in terms understandable to the patient, or 2) the intended outcome. An example of the diagnosis is "total replacement of the left hip for advanced osteoarthritis," the reason in this case is "advanced osteoarthritis." An example of the intended outcome is "surgical release of a tendon to increase the range of motion in the left thumb." This information is included so that patients will speak up if they believe that the wrong procedure is on the form. For example, if the consent form says that the procedure is to address severe osteoarthritis and the patient knows that he has never been diagnosed with arthritis and is in the hospital for a heart procedure, it is likely that he will speak up. Keep this in mind when writing the reason on the consent form.

A: The site should be understandable to the patient. If it's an operation to repair a patellar fracture, you also should note that this is the kneecap. Many patients will not know the medical names for parts of the body. Be sure to include the side (left or right, if applicable) when you indicate the site.

Marking the site

A: Because the correct patient getting the correct operation on the wrong side is not the only thing we need to prevent. Over 50% of incorrect surgeries are not laterality mistakes but something else, such as the wrong patient or wrong procedure. In fact, in a review of the VA database, 36% of the incorrect surgeries were done to the wrong patient, usually one who was scheduled to get a different procedure. A patient is likely to speak up if he understands that he is supposed to have an operation on his chest at the midline and the surgeon wants to mark a site on his abdomen or leg.

A: A non-toxic marker that meets FDA requirements for medical use and will not wash off when the site is prepped can be used for marking the site. For instance, surgical pens are available from surgical supply houses.

A: We searched the literature on this topic. There is no evidence that markers have transmitted disease from one patient to another. The site will be prepped with an antiseptic after the mark has been applied. But just in case, common sense would dictate that if a mark is being applied to a patient's broken skin or to a patient known to have acommunicable skin disease, the marker should be discarded after that use.

A: It is true that the mark may not be as readily apparent as the mark on a light-skinned patient, but a dark blue or black marker will provide a discernible mark on any patient. If the mark is not visible and the staff or patient are concerned, a special-purpose wristband can be used in addition to the mark.

A: It must be a privileged provider that is scrubbed in as part of the OR team and scheduled to be in the OR for the procedure. Depending on local VA facility policies, privileged providers may include, for example, Podiatrists, Nurse Practitioners, and Physician Assistants.

A: The absence of the person who marked the site is not a reason to cancel the operation. If the person who marked the site cannot participate in the surgery as planned, then the surgery should take place with another provider filling in, if this would normally occur. The change in staff should be documented and discussed in the "time-out" in the OR. It is expected that this would be an unusual occurrence.

A: We recommend that the physician or other privileged provider use their two or three letter initials. Other options are to use an "X" or the word "YES." It is strongly recommended that only one of these three options is adopted for each facility and used consistently. The most important thing is that the mark be unambiguous.

A. The mark should be as close as possible to the site of the incision. A significant fraction of incorrect site surgeries are on sites close to the intended site, for example the wrong intervertebral space, the wrong finger on the correct hand, or the wrong side of the knee. Marking very close to the site (on the correct finger) rather than just in the general area (like the back of the hand for an procedure involving the finger) can help prevent some wrong site surgeries.

A: You must mark the site or very near to it. A surprising number of the incorrect surgeries in VA over the last three years have been to sites in the groin, genitals, or somewhere on the buttocks. Patients with illnesses or other medical problems in these areas are used to having themselves examined in otherwise private areas. If an awkward conversation is necessary to do this, contrast this with how unpleasant it would be to explain to the patient why the wrong side of his scrotum was operated on or why his hemorrhoid was removed when he was scheduled for surgery on his lower back. If the patient doesn't want his or her site marked then a special-purpose wristband can be used instead. A special purpose wristband can also be used when it is clinically impossible to mark a site due to broken skin, etc. A special purpose wristband should not be used instead of a mark solely based on convenience of the practitioner or reluctance of the practitioner to mark a site (in the absence of reluctance from the patient).

Patient Identification: Asking the Patient Questions

A: People sometimes say "yes" or mumble affirmatively to incorrect information, such as a name that sounds similar to their own. Some patients are also hard of hearing or may not be listening carefully to what seems like another routine question. Making the patient state their name and other identifying information and having the nurse or other caregiver check the answers is a better approach and the required step.

A: We believe that the best time to do this is just before the patient is wheeled into the OR. This minimizes the chance of a patient mix-up occurring in a holding area or hallway after the patient has stated their identifying information but before they are brought into the OR. This is especially important in cases where a number of patients will be operated on in relatively quick succession and on the same general site, as in eye or knee procedures. The data suggest that eye operations are especially vulnerable to wrong-patient, wrong side, and wrong-implant mix-ups - especially when the patient has disease on both sides but only one side is scheduled for surgery on that day.

Time-out

A: No. The interactions at this point involve only the personnel in the operating room, (i.e., anesthesia, nursing, and surgical staff.) Since the patient does not participate in this step, there is no need to try to keep the patient awake.

A: Obviously you can't check what is not present. People should be aware of this special vulnerability. Separately, it is important to verify prior to starting the procedure that the implant/prostheses that may be required are readily available on-site in the immediate area.

Checking Imaging

A: Check that it is the correct patient, correct site, correct image (for example a recent image rather than an old one), and that the image is oriented correctly and labeled as to the patient's identity and side.

General

A: Yes. Attachment E of Directive 2004-028 lists the invasive procedures to which the Directive applies.

A: To provide tools and techniques to improve patient safety on a national scale.

A: The PSIC training program has a number interrelated of goals:

1. Provide state staff in the field (e.g., patient safety officers or those responsible for patient safety reporting and analysis, as well as for intervention initiatives) and their hospital counterparts (as selected by the state) with the knowledge and skills necessary to conduct effective investigations of adverse medical events and close calls (sometimes called "near misses") by identifying the root causes of these incidents, and, most importantly, prepare them to implement meaningful corrective actions based on their findings. They will also be able to do proactive risk assessments and develop and implement corresponding mitigation initiatives.
2. Prepare meaningful reports on their findings.
3. Develop and implement sustainable system changes based on findings.
4. Measure and evaluate the impact of the safety intervention (i.e., that will mitigate, reduce, or eliminate the opportunity for error and patient injury associated with or due to the delivery of health care).
5. Ensure the sustainability of effective interventions by transforming them into standard practice.

A: Patient safety is a critical aspect of healthcare. An Institute of Medicine report published in 1999, To Err is Human , estimates that 44,000 to 98,000 people each year die from medical errors. Even the lower estimate is higher than the annual mortality from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516), thus making medical errors the eighth leading cause of death in the United States.

A: States anticipate growing responsibilities to analyze reported adverse medical events and close calls, as well as to develop methods to eliminate or reduce injury to patients associated with these events. However, state representatives have noted a lack of resources, both financial and personnel, to adequately address these issues, strongly expressing a need for technical assistance with their efforts to improve patient safety. In response, AHRQ developed a concept ¾ the Patient Safety Improvement Corps ¾ that was designed to provide states and their selected hospital counterparts with training and technical assistance to support efforts to identify, analyze, and reduce medical adverse events and close calls ¾ a major step in eliminating patient injury associated with the delivery of healthcare.

A: NCPS will develop practical patient safety training sessions for state staff members and their selected partners. These individuals will then implement patient safety improvement processes within their respective states and institutions.

A: Yes. The content and structure of the program is driven primarily by the need to provide practical, short-term training for state staff in the field who are charged with analyzing reported data reflecting patient injury (or potential for injury) associated with the delivery of healthcare. It will help them identify the causes (i.e., risks, hazards, medical errors) of healthcare-associated injury (or potential injury) and develop interventions to reduce or eliminate those causes. Students will also learn how to assess the effectiveness of interventions to better ensure the sustainability of effective interventions that improve patient safety.

A: Three identical training courses, each of which lasts one year, will be offered from September 2003 through June 2006.

A: The first session begins the week of September 15, 2003 in Crystal City, Va.

A: This program is based on a systems approach to problem solving. It focuses on prevention, not punishment. It uses Human Factors Engineering methods and applies ideas from "high reliability" organizations, such as aviation and nuclear power, to target and eliminate system vulnerabilities.

A: We believe that people come to work to do a good job, not a bad one. Given the right set of circumstances, any of us can make a mistake. We must force ourselves to look past the easy answer ¾ that the adverse event was someone's fault. We look at the tougher question: Why did this adverse event occur? It is seldom for a single reason. A chain of events that has gone unnoticed most often leads to a recurring safety problem and is seldom related to the actions of one individual.