Frequently Asked Questions
National Center for Patient Safety
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.
Q: What organization is NCPS a part of?
A: We're part of the Veterans Health Administration (VHA), the largest integrated health care system in the nation.
The VHA serves the needs of America's Veterans by providing primary and specialized care, as well as related medical and social support services. Our health care system supports innovation, empowerment, productivity and continuous improvement.
Q: How large is the organization?
A: NCPS represents a unified and cohesive patient safety program. All 170 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, Mich., Washington, D.C., and White River Junction, Vt., and offers expertise on an array of patient safety and related health care issues and initiatives.
Q: What is unique about NCPS' mission?
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.
Q: What is Human Factors Engineering?
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.
Q: What is important about taking a systems approach to develop and implement health care solutions?
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.
Q: Did you develop the systems approach on your own?
A: No. Other high-risk industries, such as the airline industry, 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.
Q: How do you investigate problems?
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.
Q: How do you employ the RCA method?
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.
Q: What are "de-identified, aggregated findings"?
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.
Q: Can you provide an example of how you focus on prevention, not punishment?
A: Yes. One example is the Health Care Failure Mode and Effects Analysis (HFMEA) program. HFMEA 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.
Q: What patient safety reporting system is used by the Veterans Health Administration?
A: In 2018, the Veterans Health Administration began using the Joint Patient Safety Reporting system or (JPSR) which standardizes event capture and data management on medical errors and close calls/near misses for the Military and Veterans Health Systems.
The joint application (with DOD) improves identification and documentation of patient safety related events for VA medical center, military hospital and clinic staff, active duty, Veterans and their families. Joint processes standardizes the collection of common data points and encourages increased collaboration through the pursuit of common goals.
This effort provides more awareness and insight into safety related incidents which increases the early detection and prevention of patient harm.
Q: Why is patient safety important?
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.
Q: What is 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.
Q: What kind of reports do you routinely receive?
A: We receive reports of all types; there is no "typical" report.
Q: What is an example of a close call?
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.
Q: Why is reporting close calls so important?
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 occur as many as 300 times more often than actual adverse events.
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.
Q: When you study such things as close calls, how do you handle the data you receive?
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.
Q: Will your system prevent all incorrect medical procedures?
A: All medical procedures involve risk. Our systems approach to health care solutions is designed to reduce the risk to a minimum.
Q: What do you mean by an adverse event?
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.
Q: Do you have a blame-free system?
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.
Q: How do you define an intentional unsafe act?
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.
Q: How does human factors design and usability fit into patient safety?
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.
Ensuring Correct Surgery Directive
Q: One of the requirements for the consent form is that it states the reason for the procedure; what does this mean?
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.
Q: What should we put in for the procedure site?
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
Q: What kind of pen or marker should we use?
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.
Q: Is it Ok to re-use markers? Does the marker have to be sterile?
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 a communicable skin disease, the marker should be discarded after that use.
Q: How about marking the skin of patients with very dark skin?
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.
Q: Other than a physician, what kind of privileged providers can mark a site?
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.
Q: What if the person who marked the site is not available to do the surgery?
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.
Q: What kind of mark is acceptable?
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.
Q: How about marking embarrassing sites?
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
Q. Why do we have to ask the patient to state their name instead of just having the patient confirm their name?
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.
Q: Where and when should the patient identification step occur?
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
Q: Does the patient have to be awake for this?
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.
Q: How do we check the implant in the cases when it isn't supposed to be in the room at the outset of the procedure?
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
Q: What are we supposed to do when we check images?
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
Q: Does this Directive apply to invasive procedures such as chest tubes?
A: Yes. Attachment E of Directive 2004-028 lists the invasive procedures to which the Directive applies.
Q: Are wrong surgeries really a problem? How often does this really happen?
A: As a reportable sentinel event, wrong site surgery is frequently reported to the Joint Commission and has an estimated rate of 0.09 to 4.5 events per 10,000 surgeries. This range reflects a variety of reports from various hospital settings (with different definitions of adverse events)1. For 2016 there were 104 incorrect surgery events reported to the Joint Commission (wrong site, wrong patient, wrong procedure).2 It was the second highest reported event next to retained foreign body, making up 12.6% of all events reported to the Joint Commission in 2016.2 In 2001 in New York State a wrong surgery occurred at a rate of 1 in 15,500 surgeries (0.0065%). In VA in 2001 2009 it was about 1 in 30,0000.4 per 10,000 surgeries (0.004%); that's a little over bout one a month. We have seen a decrease over time, between 2001 and 2009, in reported adverse events with a high severity of harm rating (SAC 3)3. However, we We cannot be satisfied with this rate. The VA National Surgery Office and the National Center for Patient Safety believe that these steps will significantly reduce the incidence of wrong surgeries in VA. We also hope that other organizations will find our approach useful.
1. Devine J, Chutkan N, Norvell DC, Dettori JR. Avoiding wrong site surgery: a systematic review. Spine (Phila Pa 1976). 2010;35(9)(suppl):S28S36.
2. The Joint Commission: Summary Data of Sentinal Events Reviewed by The Joint Commission. 07/11/2017 statistics. Retrieved 2.9.2018.
3. Neily J, Mills PD, Eldridge N, et al. Incorrect surgical procedures within and outside of the operating room. A follow up report. Arch Surg. 2011; 146(11): 1235-1239.
