Patient Safety Alert

JCAHO patient safety standards stress leadership

Experts call the new standards proactive, specific

The Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, has approved new standards that focus directly on patient safety and medical/ health error reductions in hospitals.

"What we hope to accomplish is to create an environment that encourages staff to bring forward error identification and to encourage hospitals to take a proactive approach — to identify and address high-risk activities before errors happen," says Charlene D. Hill, a spokeswoman for the commission. The standards are scheduled to take effect July 1, 2001.

While some in health care have criticized the standards for belaboring the obvious, reaction has, by and large, been positive. "This is a very important step in the facilitation of safe practices," asserts Louis H. Diamond, MB, ChB, FACP, vice president and medical director of MEDSTAT Group Inc. in Washington, DC, and member of the board of directors of the Chicago-based National Patient Safety Foundation.

"It puts operational meat behind the IOM [Institute of Medicine] report and will further focus the leadership of hospitals on the importance of dealing with safety issues explicitly rather than implicitly. It will further cement the movement in the direction of improved patient safety," he says.

Diamond dismisses critics who say the standards are merely outline steps "everyone knows" should be taken. "The notion that this should have been done already’ implies that organizations like the commission or purchasers shouldn’t do anything that drives change," he retorts. "It really begs the question, because a lot of what should be done isn’t being done."

Patrice L. Spath, who heads up Brown-Spath Associates, a Forest Grove, OR-based health care consulting firm, is particularly impressed with the proactive nature of the standards.

"Health care organizations can’t wait for a sentinel event to occur before taking patient safety improvement seriously," she asserts. "The new standards require proactive error reduction initiatives for high-risk processes that have the potential for error and patient harm. This means that at least annually the organization must undertake one proactive patient safety improve-ment project."

The standards are divided into three major areas: leadership; management of information; and other functions (i.e., patient rights, patient education, continuity of care, human resources). The fact that leadership is the first and most comprehensive section is no accident, says Diamond.

"If I had to choose one area, leadership is absolutely critical," he says. "Without leadership involvement, commitment, and the assignment of resources, success cannot be achieved. But this will require more than just raising the flag every morning; you have to cause things to happen by assigning resources, by reviewing progress, and by being involved. The Joint Commission’s outline clearly lays that on the table. I would have done things in exactly the same order. They start the process by requiring specific actions by leadership and a whole host of programs that are measurable down the road that the commission and hospital boards will be able to assess."

It is important, Spath warns, that people don’t interpret the Joint Commission’s patient safety standards to mean that assurance of individual competencies is no longer important. Leadership must be cautious about how it interprets the standards, she says, referring to Joint Commission language that recommends "minimization of individual blame or retribution for those involved in an error or in reporting an error."

"Although process improvement is the goal, the organization’s leaders still have the responsibility to protect patients from incompetent clinicians," she emphasizes. "The medical staff must still perform credentialing functions and assess peer performance. Managers must still validate the training and skills of staff. Action must still be taken when an individual is found to be a contributing cause for a sentinel event."

The goal of patient safety improvement, however, is not to single out an individual for additional training or for disciplinary action, Spath emphasizes. "When people work on a patient safety improvement project, their focus should be on redesigning processes and systems to prevent human errors from reaching the patient," she says.

While Diamond is generally supportive of the standards, he admits they are far from perfect. "There is a tension between the standards and the requirement to do the right thing with the resource allocation that has to be identified and assigned; there is a limited pot of money at the institutional level. This will be a challenge. The system will have to work through the capital outlays, training, and operational outlays that will have to be expended."

The benefits are clear, Diamond says. Not only will there be improved outcomes and safety, but also financial benefits. "We will reduce adverse drug reactions, complications, lengths of stay," he notes.

"The question is, who reaps the benefits of those savings? The relationships between the physician and the hospital, the managed care organization and private sector purchaser or Medicare/Medi-caid are all defined by perverse payment schedules that don’t address how we can do this so that everybody wins. For instance, if you are a hospital on a capitated global payment and you can reduce length of stay, clearly the financial gain accrues to the hospital if you deliver services at less than the expected cost. But if you’re on fee for service, the reduced length of stay accrues to the purchaser, even though they are not making the investment in improved safety."

The bottom line, says Diamond, is that there will be ongoing, complex tensions among doing the right thing, fulfilling the standards’ requirements, and finding the resources to get the job done.

Coordinating all the various patient care improvement projects also may prove to be a daunting challenge, predicts Spath. "To ensure consistency of purpose, any initiatives related to patient safety, whether they are undertaken by the infection control committee, the product evaluation committee, the pharmacy and therapeutics committee, or any other group, should somehow be aligned under the organization’s overall performance improvement function," she advises.

"There’s also the legal issue of discovery that needs to be considered. In some states such as Connecticut, sensitive information related to sentinel events can only be protected from legal discovery when the root cause analysis and proactive error reduction investigations are aligned under the peer review function," Spath says.

Another challenge for organizations may be to learn how to take the numerous hazard analysis techniques that have been used in other industries to error-proof the process and adapt them to the health care setting. "These techniques can be used to assess the potential for human error in a process and determine what, if any, patient harm might occur if an error actually occurs," she explains. Information for this examination is based primarily on the following:

• Observation of the current process (e.g., simulations, walk-throughs, or talk-throughs).

• Operational experience (e.g., examination of past incidents and errors).

• Prediction of anticipated adverse events.

Hazard identification techniques likely to be useful in health care organizations include:

• checklist analysis;

• what-if analysis;

• failure mode and effect analysis;

• barrier analysis;

• critical human action profile;

• human compliance analysis;

• could-this-happen-here scenario.

[Each of these hazard analysis techniques is described in the Patient Safety Improvement Guidebook 2000, available from Brown-Spath & Associates. Telephone: (503) 357-9185. Web site: www.brownspath.com.

For more information, contact:

Patrice L. Spath, Brown-Spath & Associates, P.O. Box 721, Forest Grove, OR 97116. Telephone: (503) 357-9185. E-mail: patrice@brownspath.com.

Lou Diamond, MB, ChB, Board of Directors, National Patient Safety Foundation, Chicago. Telephone: (312) 464-4848.

Charlene D. Hill, Joint Commission on Accredita-tion of Health Care Organizations, One Renaissance Boulevard, Oakbrook Terrace, IL 60181. Telephone: (630) 792-5175. E-mail: chill@jcaho.org.]

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Medication study may bolster compliance

A recently released on-line study of medication errors by Rockville, MD-based United States Pharmacopoeia (USP) will help health care institutions comply with the new safety standards of the Joint Commission on Accreditation of Healthcare Organizations, says a leading USP executive.

"The standards ask hospitals to look at errors and the solutions implemented by other facilities so they can learn from one another," notes Diane Cousins, RPh, USP’s vice president for practitioner and product experience. "That’s what this database enables."

USP has been involved in medication error-reporting for nearly 10 years, but only recently introduced MedMARx, an Internet-accessible, anonymous database that allows hospitals to report and track medication errors. The first full year of data collection ended Dec. 31, 1999.

The report, which summarizes data of 6,224 medication error records from 56 facilities, found the following:

• Most errors (97%) did not result in patient harm.

• The three most frequently reported types of errors were omission errors (i.e., failure to administer an ordered medication dose); improper dose/quantity errors; and unauthorized drug errors.

• Errors originated in two primary areas of the medication administration process: administering and documenting.

• In 32% of the records where documented action was taken due to a medication error, the personnel involved with initiating or perpetuating the error were reportedly not informed of their involvement in the event.

Cousins says much can be learned from the findings of the study. For example, a surprising 97% of the reported errors did not result in patient harm.

"There is a lot of opportunity in that 97% for improvement," she asserts. "It’s the scary things that happen — the near-misses — that are life’s lessons learned. For example, what were the safety nets that prevented patient harm, and how can we reinforce them? Was the error just caught by chance? If so, we may not be so lucky the next time. We will learn more in the next report as these things play out."

The types of errors reported were not a surprise, says Cousins. "What we saw here were the same top three we’ve been seeing through our medica-tion errors reporting program over the past 10 years. It’s not necessarily surprising when omis-sions rise to the top in a hospital-based setting. But this should raise a red flag; these are the areas we need to pay attention to, and where we can, therefore, affect our overall error rate."

Nor was Cousins surprised about errors originating in medical administration. "If you think about the continuum of prescription, documentation, and dispensing, and then finally getting to the point of administering, it makes sense that you’re probably more likely to find errors at the administration phase," she says. "Even if you go to the outpatient setting and see how many doses are made to patients, that’s where you will see the change in status or the reaction of a patient. The closer you get to the patient, the fewer safety nets you have and the more likely it is that an error will occur."

Taking a closer look

As so often happens with statistics, some of USP’s findings require a closer look. Take, for example, the percentage of individuals involved in error who were not informed of their involve-ment. "We want to follow that one over time," says Cousins.

"We understand that some forward-thinking hospitals may be focusing on systemwide errors. What worries us is if people are not informed they have been involved in errors, they won’t be able to modify how they interface with the system. They’ll never hear the full details of the event, and ulti-mately, they will not be able to change their behavior. One of the advantages of talking over these situations is the facility learns more of the details involved in errors and is, therefore, in a better position to change policies and procedures."

Cousins also was surprised to find that wrong patient errors were among the larger categories of types of errors. "There are lots of reasons why this happens, but there is also lots we can do to prevent it," she says.

Perhaps not as surprising was the fact that computer entry was among the top 10 causes of error. "While computers can eliminate error, there are also new errors introduced because of computerization," says Cousins. "It’s a function of how you design your system and the way people interface with it."

In some systems, for example, you may not be able to readily discern between two similarly named medications, Cousins continues. "As we build medication use processes, the more complex they are the more likely they are to be error-prone," she concludes.

[For more information, contact: Diane Cousins, RPh, U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852. Telephone: (800) 822-8772. Internet: www.usp.org.]

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Video helps staff take a new look at safety

An in-house video depicting the commission of medical errors is revolutionizing the way staff at Overlook Hospital in Summit, NJ, view the cause and prevention of errors.

Produced at a cost of only $200, the video was inspired by a "Lehrer News Report" program on the off-Broadway show CVR (Charlie Victor Romeo), which details the causes of airline accidents. It was first shown about two months ago.

"Jack and I synapsed’ on the show, and said, Why not make our own videos?’" recalls James Espinosa, MD, FACEP, FAAFP, chairman of the emergency department at Overlook.

Espinosa is referring to Jack Scharf, vice president of quality and outcomes management for Atlantic Health, a four-hospital system to which Overlook belongs.

"There are a number of similarities between the causes of airline disasters and the causes of medical errors," he notes. "These include distraction, noise, conflict, and too much reliance on technology."

The effect of the video on the staff (mainly nurses) who have viewed it has been dramatic. "In our evaluation questionnaires, the staff said the video was a very effective tool in helping them understand the factors that contribute to allowing error to occur," says Tina Maund, MS, RN, director of performance improvement at Overlook.

"Earlier in the session, the first inclination is to say the event is the fault of the last person who brought the error to the patient," she says. "After viewing the video and an analysis session led by a facilitator, the participants reported that they saw the domino effect,’ and how important other factors are — the people and the situations where safety barriers broke down or were circumvented. Then, they are able to come up with very good suggestions to take back to their unit."

"When people see the video they are riveted," adds Espinosa. "They talk to it, and when they see someone about to make an error they actually shout, Don’t do that!’"

The video was part of a larger collaborative project with the Institute for Healthcare Improve-ment (IHI) in Boston to increase cultural awareness of safety. It also involved the creation of a safety lab where live re-creations and simulations will be produced.

The program’s creators agree that two major elements are the root of the video’s success: significant leadership involvement and the sheer power of storytelling.

"Jack plays a role in the video, and I play the director of the ER," says Espinosa. "And we will have a CEO in a future video. The message this sends is that this is big. The leadership function is nondelegatable around culture."

"Storytelling is a very powerful way of changing culture — especially regarding medical error," adds Scharf. "There’s been this traditional code of secrecy and silence to avoid recriminations and liability. There’s also been this sense that we are perfectionists. The video’s storytelling frees other individuals up to tell their stories; it gets us out of this punitive perfectionist accountability model to where we begin to look at latent causes. It’s not that people aren’t responsible, but we now know there’s so much else going on."

[For more information, contact: James Espinosa, MD, FACEP, FAAFP, and Tina Maund, MS, RN, Overlook Hospital, 99 Beauvoir Ave., P.O. Box 220, Summit, NJ, 07902-0229. Telephone: (908) 522-5310. E-mail: tina.maund@ahsys.org.]