never events

Ken Kizer, a physician and former chief operating officer of the National Quality Forum, coined the term “Never Events”. These are particularly shocking medical errors, like operating on the wrong patient, that should never happen. The NQF defined 27 such events in 2002 and revised and expanded the list in 2006. The list is grouped into six categorical events: surgical, product or device, patient protection, care management, environmental, and criminal. They are also referred to as serious reportable events. Some or all of these events are reportable to state agencies. Organizations accredited by The Joint Commission are expected to report these events to The Joint Commission.

See the list: SRE_FactSheetv2

Beginning October 2008, the Centers for Medicare and Medicaid Services stopped reimbursing hospitals for care that resulted in one of a limited list of never events. Private payors followed suit. The healthcare facility is not permitted to bill the patient for the revenue that was lost as a result of this never event.

Why do these events continue to happen? Health care is incredibly complex and there are multiple opportunities for errors – related to communication, the environment, fatigue, stress, and a host of other factors. Healthcare providers don’t want set out to hurt people – this blog explores some of the reasons why that happens and how that influences the litigation process.

Wrong site wrong patient surgery-inexcusable medical error

“Everyone was under the assumption that when the so-called universal protocol was implemented in 2004, it would lead to a decrease in these ‘never events,’ ” said study lead author Philip F. Stahel, MD, PhD, director of the Dept. of Orthopedic Surgery at the Denver Health Medical Center. “Not only did they not decrease, they increased. In the first few years, the universal protocol did not prevent these never events from happening.” Read more

Who are the surgeons at biggest risk for performing wrong patient or wrong site surgery? Orthopedic/pediatric, general surgery and neurosurgeons. Not surprisingly, they are a bit defensive about the results of this study.

How do you prevent wrong patient and wrong site surgery? Simple: follow the protocol step by step.

How does this happen, you ask? The Joint Commission looked at the risk factors in its Sentinel Event Alert in August 1998. One factor is production pressure. Move the patient in, operate, move her out, clean the room, move in the next patient. Emergency surgeries are high risk, as well patients with unusual physical characteristic, including morbid obesity or physical deformity. Staff working with unusual equipment or patients having multiple surgeons and procedures are at increased risk.

What can operating room staff do to stop this inexcusable medical error?
1. Correctly identify the patient. One of Med League’s operating room nursing experts worked on a case of a childless woman who got someone else’s tubal ligation. It is notoriously difficult to reverse a tubal ligation. No one identified her before starting surgery.
2. Ask an awake and alert patient to identify the surgical site. My mother carried a sign into the operating room before her right lung wedge resection. Her sign said, “It is my right lung.” One of the OR nurses told her she was cute. She retorted, “No, cautious.” A teenager who needed a left knee surgery wrote on her right knee, “Doctor, if you are looking at this knee, don’t.”
3. Create and use a verification checklist that includes the operative consent and any imaging studies.
4. Obtain oral verification of the patient, surgical site, and procedure in the operating room. Involve everyone, including the surgeon, in the verification. One of Med League’s operating room nursing experts worked on a case which involved a failure to correct identify the site. The patient came into the operating room at change of shift. The incoming staff assumed the outgoing staff had performed the verification process. She received surgery on her right knee instead of her left.
5. Expect to not get paid for surgery performed on the wrong patient or site. CMS and private payors will no longer pay for these errors.
6. Administrators, do not tolerate surgeons who want to rush people through the last and most important safety check in the OR. Leadership is top down. There can be no tolerance for shortcuts.
7. Get out your checkbook. These cases are inexcusable and will not happen if people follow the protocols designed to protect the patient.
Read more about why healthcare providers do not follow the rules part one and part two.
This is an overview of a recent article in New England Journal of Medicine about the factors that led a hand surgeon to operate on the wrong site.
Pat Iyer is president of Med League.

MRSA skin infection

The Joint Commission has released the 2010 National Patient Safety Goals. The Joint Commission sets standards for, evaluates, and accredits more than 16,000 healthcare organizations and programs in the United States. These include hospitals and home health agencies as well as ambulatory care services, behavioral health programs, clinical laboratories, and long term care organizations. In addition, The Joint Commission provides certification of disease-specific care programs, primary stroke centers, and health care staffing services.

The 2010 effort has streamlined the goals, refined language, and emphasized the importance of the healthcare-associated infections goal. This goal was first released in 2009 and is to be fully implemented in 2010. There has been increased attention paid to the development of healthcare-associated infections due to multi-antibiotic resistant organisms. Some states collect information from hospitals and report on the incidence of such infections. Some plaintiff attorneys have filed suits related to hospital-acquired infections, under these theories of liability:

1. Transmission of infection to the patient
2. Delay in diagnosis of infection
3. Improper treatment of infection

The 2010 Goal applies to methicillin-resistant staphylococcus aureus (MRSA), clostridium difficile (c-diff), Vancomycin-resistant enterococci, multidrug-resistant gram-negative bacteria, among others organisms. The goal focuses on:

1. Conduction of periodic risk assessments for multidrug-resistant organism acquisition and transmission
2. Provision of education for staff at the time of hire and annually thereafter
3. Education of patients and families who are infected or colonized with a multidrug –resistant organism about healthcare-associated infection strategies
4. Implementation of a surveillance program for multidrug-resistant organisms based on the risk assessment
5. Measurement and monitoring of prevention processes
6. Provision of multidrug-resistant organism process and outcome data to key stakeholders, including leaders, licensed independent practitioners, nursing staff and other clinicians
7. Implementation of policies and practices aimed at reducing the risk of transmitting multidrug-resistant organisms
8. When indicated by the risk assessment, implementation of a laboratory-based alert system that identifies new patients with multidrug-resistant organisms
9. When indicated by the risk assessment, implementation of an alert system that identifies readmitted or transferred patients who are known to be positive for multidrug-resistant organisms

What can you do to protect yourself and your loved ones in a healthcare environment? The single biggest action you can take is to insist that healthcare providers wash their hands before contact with the patient. This is not the time to be shy. Speak up. This is an issue foremost in my mind this week as my husband prepares to enter the hospital for a triple bypass. I’ll be washing my hands before touching him and trusting that the healthcare providers will do the same.

Swiss Cheese Model

The Swiss Cheese Model is another way to view patient safety. In James Reason’s model, the holes line up in the system; a patient passes through and is injured. When a series of errors occur, if anyone along the chain of events had done something different, the patient would not have been injured. Those of us who work in the medical malpractice arena can think of cases where this unfortunate cascade of errors has occurred. For example, I worked on a nursing malpractice case involving a man who received the wrong type of blood. Another patient and he had the same name; a mix up of identity occurred. The admissions clerk, laboratory technician, unit secretary, hematologist and several registered nurses were part of the chain. The blood bag was not checked at the bedside with the patient’s identification band; he died as a result of receiving the incorrect blood type.

What does the concept of zero-defects mean in practical terms? I am reminded of the reaction I saw when a surgeon told a patient there was a 1 in 100 risk of a certain complication occurring in the operating room. The patient asked, “What number am I in your total of 100?” It is only human nature to want the other guy to be the one case while we cling to the 99.

Attention to the goal of zero-defects also reveals what risk managers and family members fear: some patient injuries are not reported, starting with the person directly involved in the incident and ranging through leadership. The Joint Commission acknowledged this reality: “Leaders must consistently make safety a top priority in their decision-making. Safety must be supported at all levels of the organization and by both administrative and clinical leaders. Unfortunately, patients and health care staff may perceive a considerable difference between what leaders say and what is actually occurring—for example, when leaders do not support the reporting or managing of errors for fear of litigation.” In reality, it it’s the hiding and cover-up that sends some patients to plaintiff attorneys so that they can get answers to the question of what went wrong.

I recall sitting in a hospital Pharmacy and Therapeutics Committee meeting some years ago while the director of nursing had to explain each of the 6 medication error incident reports that had occurred that month in a 600 bed hospital. The physician said, “I want there to be zero errors!” I pulled the vice president of nursing aside and said, “We’re not getting accurate reporting. Statistically, there should be a much larger number of incident reports.” She disagreed. However, the nursing department disciplined nurses who made errors. The policy was to terminate the nurse after three errors had occurred. Not surprisingly, nurses were reluctant to report errors, as they functioned within a culture of fear.

That culture of fear is being replaced by a culture that focuses on just handling of staff after an error occurs. The Joint Commission addressed this inherent conflict in the new Sentinel Event Alert: “Actions taken in response to adverse events can be administrative or disciplinary as well as safety-related. These actions must not only be fair, they must be perceived to be fair; otherwise, future reporting of events may be discouraged. Such an approach is consistent with a culture of safety and is symbolic of a ‘just’ culture. A just culture is not wholly blame-free. It is one that has a clear and transparent process for evaluating errors and separating egregious unsafe acts from the small errors that people make every day, because we are human. The large errors are considered for disciplinary action with a set of guidelines that are applied equitably and consistently across all groups within the organization. It is the small errors that should not be cause for blame or punishment but should rather be recognized as important sources of information about system vulnerabilities.”

Leaders have critical roles to play in supporting staff who report errors and in making the changes needed to plug holes. The Joint Commission’s Alert is a needed directive to add more light to a subject that can hide in the shadows of the corner.

What change in healthcare would lead to the greatest improvement in patient safety? A survey of nurses found these answers:

Mandated staffing ratios: 48.2%
Better communication between nurses and doctors: 29.3%
Electronic medical records: 14.2%
Automated medication administration: 8.3%
Source of study: Advance for Nurses, December 22, 2008

Implications for the attorney/legal nurse consultant: When investigating a nursing malpractice case, ask about mandated staffing ratios. Were there any? How many patients were assigned to the nurse at the time of the incident? Was there a persistent pattern of understaffing? Ask for the staffing sheets and have your expert review them to see if they conformed to industry standards.

According to the Joint Commission’s study of sentinel events/medical errors, communication is the number one factor that results in sentinel events. Miscommunication may occur due to fatigue,  distraction, misunderstandings, accents, failure to communicate, hierarchical issues, not having English as a primary language, bullying, and a host of other factors. These factors should be explored to see if and how they contributed to an untoward outcome.

Electronic medical records are coming- but slowly. They improve efficiency and access to information, which may increase patient safety. But there are privacy, security and confidentiality issues that raise concerns among patients and providers. Computerized medical records carry significant cost and operational issues that are major challenges within health care. At a recent meeting of the American Society of Healthcare Risk Management, many of the risk managers told me they were concerned about the quality of information provided by computerized medical records. Critical information about an incident was not always captured by the records, making it difficult to reconstruct what had occurred. Computerized medical records are an improvement over handwritten records, but many agree they are not a panacea. We’ll never eliminate the need for a thoughtful healthcare provider at the other end of the monitor.

The survey results that identify “automated medication administration” as a patient safety feature may refer to one of two patient safety innovations:

1. The use of an automatic drug dispensing cart, which contains medications in a series of cubicles.
2. The use of bar codes to identify the correct patient to make sure there is a match with the right drug, dose, time and route of administration.

Although neither of these innovations is fool-proof (or immune from attempts to “work-around” these safety features), both of these innovations have been associated with improved safety in medication administration.

What do you think? What can nurses do to make patient care safer?

Children are at high risk for the ill effects of medication errors- they have little ability to survive a catastrophic medication error. The American Nurses Association and the American Nurses Association/California won an important victory involving administration of insulin to children by unlicensed personnel. The groups obtained a court order to stop the unlawful use of unlicensed personnel to give insulin to California school children. The effort to stop the practice was based on the premise that nurses who provided training and oversight to unlicensed personnel were at risk for disciplinary action by the state board of nursing. The administration of insulin by unlicensed personnel violated the Nursing Practice Act. The judge who issued the opinion in November 2008 stated that the Department of Education did not have concurrent authority over the administration of medications and could not override the Nursing Practice Act.

Source of news report: The American Nurse, November/December 2008

See our Medication Error DVD for more information about the subject.

Pat Iyer MSN RN LNCC is president of Med League. She has assisted many medical malpractice attorneys with cases involving medication errors.