Safety Share

September 2006

Dear Colleague:

Premier will soon have a newly designed Web site for easier navigation. The Safety Institute home page will be the same at www.premierinc.com/safety, but the tools and resources will be easier to find.

Please be aware that any saved links (favorites) to the Safety Institute's content will need to be updated after the new site goes live.

Sincerely,
Gina Pugliese, editor
Vice President, Premier Safety Institute

News

Safety tools

RFID used to detect retained surgical sponges

A clinical evaluation conducted at Stanford University Medical Center found that handheld wand-scanning devices were able to detect surgical sponges tagged with radio frequency identification (RFID) chips, enabling OR personnel to detect sponges inadvertently left inside patients. The study, published in the July Archives of Surgery, found that the wand detected the tagged sponges 100 percent of the time in an average of fewer than three seconds.

Retention of foreign objects is relatively common
It is estimated that foreign objects are left in patients in one of 10,000 surgical procedures with open cavities, two-thirds involving sponges, according to a 2003 study by Gawande published in the New England Journal of Medicine. Gawande reported that cases in which retained surgical sponges or instruments are most likely to occur include emergencies, unplanned changes in procedure (such as converting from a laparoscopic to an open technique), and patients with a high body mass index. The study also found that 88 percent of cases of retained foreign bodies in which counts were performed had a final count that was erroneously thought to be correct.

RFID technology could provide additional patient safety benefits beyond routine X-rays when there is a discrepancy in the instrument or sponge counts.

Downloads and links

RFID sponges, Arch Surg abstract (.doc) (25 KB)

Retained instruments sponges, NEJM abstract (.doc) (26 KB)

Back to News

 

FDA requests comments on identification of medical devices for safety

The Food and Drug Administration (FDA) is seeking information on how the use of a unique device identification (UDI) system may improve patient safety by reducing medical errors, facilitate device recalls and improve medical device adverse event reporting. The agency said it is interested in understanding the issues associated with the use of various automatic identification technologies such as bar codes and radio frequency identification. In addition, the FDA is seeking comments on the feasibility, benefits, and costs involved in the development and implementation of a UDI system. A notice in the Federal Register seeks public comment through November 9, 2006. A public meeting is planned in the fall and the FDA will provide details when they become available.

Premier has been a strong advocate for the unique identification of medical devices in Washington and is working on its comments to submit to the FDA. Premier is seeking information from hospitals – particularly responses to hospital-specific questions 15-20. If your hospital has experience implementing any form of unique identification on your medical device labeling and can provide insight from the hospital perspective to these questions, please contact Linda Rouse, director of Federal Affairs, at 202.879.8005, or linda_rouse@premierinc.com .

Congress and stakeholders request FDA to revisit identification of medical devices
On February 26, 2004, the FDA published a final "bar coding" rule (69 FR 9120) requiring bar codes on certain human drug and biological products to help reduce medication errors. The bar code rule, however, does not apply to medical devices. The FDA notes that unlike drugs, medical devices do not have a standardized UDI system comparable to the NDC number.

Since the final bar code rule was issued in 2004, members of Congress and industry stakeholders including hospital groups have asked the FDA to revisit the issue of bar coding of medical devices to improve patient safety and quality of care as well as encourage cost effective healthcare by improving healthcare delivery and supply chain efficiency.

Development and implementation of UDI system
The FDA believes that a unique device identification system could be used 1) to uniquely identify a specific device (e.g., to facilitate reporting an adverse event or locating a recalled device) and 2) to convey information to promote safe use.

UDI may reduce medical errors
The number and complexity of medical devices is growing. It is important for FDA to identify new risks quickly and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems. Two recent FDA-commissioned reports identified several benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions. In addition, the FDA has been working with the Agency for Healthcare Research and Quality (AHRQ) in the Department of Health and Human Services and with other federal partners to better understand the issues with the development, implementation and use of a UDI system.

The FDA said it believes a unique device identification system for medical devices could be created using bar codes or radio frequency identification technology. Each bar code or RFID tag on a medical device could include minimum data sets for:

  • manufacturer, make, and model;
  • unique attributes, include size and length;
  • serial number;
  • indications for use, contraindications, warnings and precautions; and
  • accessories needed to operate.

The FDA also suggests that this information could reside in a publicly available database.

During the comment period, the FDA wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency wants to hear about various automatic identification technologies such as bar code and radiofrequency that could be used with a UDI system.

Directions for providing comments
A list of specific questions and issues to address in the comments has been provided in the Federal Register notice. A final regulation is not expected until 2007. To submit electronic comments, visit the FDA web site. Comments must be received by November 9, 2006 and include the docket number 2006N-0292.

Downloads and links

Federal Register notice (.pdf) (60 KB)

FDA web site:
http://www.fda.gov/dockets/ecomments/
Search "2006N-0292"

Safety A-Z on Safety Institute Web site: "Bar coding of drugs, biologicals and medical devices."

Back to News

 

MRSA increasing as cause of outpatient skin, soft-tissue infections

The most common identifiable cause of skin and soft-tissue infections among patients presenting to emergency departments is methicillin-resistant S. aureus (MRSA). A recent New England Journal of Medicine study of EDs in 11 U.S. cities found MRSA was increasingly recognized among persons in the community without established risk factors for the infection.

UCLA researchers enrolled adult patients with acute, purulent skin and soft-tissue infections presenting to 11 university-affiliated emergency departments in August 2004. S. aureus was isolated from 320 of 422 patients (76 percent) with skin and soft-tissue infections and MRSA was present in 59 percent of the patients tested. The prevalence ranged from 15 to 74 percent at individual EDs. Among the 175 cases in which the patient was prescribed an antibiotic, 57 percent of prescriptions were for a drug to which the microorganism was resistant. Study authors note that most simple skin abscesses caused by MRSA can be successfully treated by adequate drainage alone. In cases of cellulitis or a draining wound with MRSA, the infection should be treated with an effective antibiotic.

Community-acquired MRSA
An estimated 2.3 million Americans carry MRSA; most show no signs of illness. MRSA is transmitted through skin-to-skin contact or shared personal items and is immune to common antibiotics. Healthy people carrying MRSA may shed bacteria with no consequence, but those with weakened immune systems may suffer blood poisoning, severe pneumonia, and even death. The Centers for Disease Control and Prevention (CDC) estimates that MRSA causes about 90,000 serious infections and kills 17,000 people a year. MRSA first began appearing in the community in clusters of athletes, correctional facility inmates, military trainees, and intravenous drug users. This community-acquired MRSA was being transmitted by sharing towels and razors, touching contaminated surfaces such as gym equipment, and close physical contact. MRSA skin infections often look like a pimple or boil that can be swollen, red and painful, and have a discharge; they are often misdiagnosed as spider bites. The UCLA study found that the infections appear to be common in people not connected to any particular risk group.

Healthcare-associated MRSA
Despite the growing numbers of community-acquired MRSA, about 80 percent of MRSA infections occur in hospitalized patients. Efforts to control MRSA have been underway with a variety of mechanisms, including testing for MRSA as patients are admitted to the hospital and isolating those who test positive. Not all agree that such universal screening is effective given other successful control efforts but note that it may be appropriate under certain conditions. Costs of testing, staff workload, the shortage of single rooms for isolation, and effect on isolated patients are factors that discourage universal screening.

National prevalence study
The Association for Professionals in Infection Control and Epidemiology (APIC) recognizes that multi-drug resistant organisms (MDRO) pose a threat to the population, and no longer are limited to persons who have had a recent encounter with the healthcare system or who have other apparent risk factors. APIC has an initiative that involves conducting a large national study titled "2006 Methicillin-resistant Staphylococcus aureus (MRSA) Prevalence Study." The study will be conducted during October 2006 and is designed to gather national data on MRSA infections/colonizations in inpatients in U.S. healthcare facilities. No healthcare facilities' identifiers or patient data will be collected; only aggregate data will be reported. To access the survey instrument, frequently asked questions, study protocol and other pertinent documents, view the APIC MRSA prevalence study online.

Prevention and control in community settings
The following steps are recommended to avoid the spread of MRSA or other infectious microorganisms:

  • Use an alcohol-based hand sanitizer (if hands are not visibly soiled) or wash hands often with soap and water to keep them clean,
  • Don't share towels, razors or other personal items.
  • Avoid contact with other people's wounds or bandages.
  • Keep breaks in your skin clean and covered and watch for signs of infection, such as redness, warmth and swelling.
  • See your doctor if you notice signs of infection; don't try to drain a boil yourself at home.
  • If you have a skin infection, keep the infected area covered with a clean, dry bandage until it is healed; clean your hands thoroughly after changing the bandage and put used bandages in the trash.

Downloads and links

MRSA NEJM abstract (.doc) (24 KB)

APIC MRSA Prevalence Study

Back to News

 

Fear of malpractice does not affect physician belief that errors should be disclosed

Ninety-eight percent of physicians surveyed. in the United States and Canada said serious medical errors should be disclosed to patients, with most (74 percent) agreeing that disclosure of a serious error would be very difficult. Fifty-eight percent of the surveyed clinicians said they had disclosed a serious error to a patient. Despite agreeing that serious errors should be disclosed, many physicians acknowledge that certain factors might make them less likely to disclose. For example, 60 percent reported that they would be less likely to disclose if they "think the patient would not understand what I was telling him or her." Other factors that would inhibit disclosure included "if I think the patient would not want to know about the error" (30 percent) and unfamiliarity with the patient (13 percent). Only 23 percent did not report that any of these barriers would affect their decision to disclose a serious error.

Physicians
These were among the findings of a mail survey of 2637 physicians (67 percent response) in the U.S. (Missouri and Washington) and Canada reported in "US and Canadian Physicians' Attitudes and Experiences Regarding Disclosing Errors to Patients" (Archives of Internal Medicine, August 14, 2006).

Concept of "systems failures" not understood by many physicians
Sixty-six percent of respondents agreed that errors are a serious problem, but 50 percent disagreed that errors are usually caused by system failures. Understanding the concept that most errors stem from a defective system is believed to reduce the culture of blame and facilitate open discussions about errors. Only half of the responding physicians disagreeing with this assertion suggest that this concept might not be fully understood.

Disclosure poses special challenges for private physicians
U.S. and Canadian physicians' beliefs and reported practices about disclosure were found to be quite similar and the malpractice environment might not be the major determinant of these attitudes and experiences. Although the medical profession has focused on malpractice as the primary obstacle to improving disclosure of errors to patients, this study highlights how factors beyond malpractice influence physicians' willingness to disclose. Being in private practice had an independent effect on disclosure attitudes. The authors noted that disclosure might pose special challenges for private physicians for reasons beyond malpractice. Private physicians may not have ready access to disclosure resources available at large healthcare institutions, such as just-in-time disclosure coaching. Training physicians in disclosure could enhance physicians' confidence in these difficult conversations.

Majority of physicians mention adverse event but not the error during disclosure
In a companion article based on the same survey, the authors report on how physicians would disclose a medical error to a patient. The survey respondents received one of four scenarios depicting serious errors that varied by specialty (medical and surgical scenarios) and by how obvious the error would be to the patient if not disclosed (more apparent vs. less apparent). Five questions measured what respondents would disclose using scripted statements.

The majority of physician respondents (56 percent) chose statements that mentioned the adverse event but not the error. Physicians in both medical and surgical specialties were less likely to disclose an error that might not be apparent to the patient. Half said they would give the patient specific information about what the error was while 13 percent would not volunteer details unless asked by the patient. For serious errors, only 33 percent would explicitly apologize while 61 percent would simply express regret. Disclosure was affected by the nature of the error and physician specialty. Surgeons were more likely than other physicians to say they would definitely disclose the error but also reported that they would disclose less information. Respondents disclosed more information if they had positive disclosure attitudes, felt responsible for the error and had prior positive disclosure experiences.

Patient view of disclosure
Meanwhile, the patient view of the issue was explored in a recent patient study of 407 health plan members on factors influencing how patients respond to the disclosure of a medical error. The study was published in the Journal of General Internal Medicine (July 2006). Patients watched video scenarios and self-reported on their satisfaction, trust, and emotional response, as well as whether they would change physicians or seek legal advice if in those situations. Respondents indicated that non-disclosure would increase the likelihood that they would change physicians and decrease their satisfaction and trust. Non-disclosure also increased the likelihood of seeking legal advice depending on the type of error; for example, a missed diagnosis would be more likely to initiate action rather than a monitoring error. This study supports the practice of full disclosure and provides further evidence that full disclosure does not increase the risk of negative consequences for physicians.

Downloads and links

Error disclosure survey abstract (.doc) (25 KB)

"Choosing Words Carefully" abstract (.doc) (25 KB)

"Disclosure – How patients respond" (.doc) (23 KB)

Back to News

 

Prescription drug warning labels often misunderstood: study

It is estimated that nearly half of the adult population in the United States lack the reading and numerical skills required to process, understand, and act on health information. A recent study published in the American Journal of Health System Pharmacy (June 2006), "Misunderstanding of prescription drug warning labels among patients with low literacy," examined common causes for misunderstanding prescription drug warning labels in adults with low literacy. Low literacy in this study was defined as reading at or below a sixth grade level.

In a structured interview, patients were asked to interpret and comment on eight commonly used warning labels found on prescription medications. The eight prescription drug warning labels used were:

  • Take with food.
  • For external use only.
  • Medication should be taken with plenty of water.
  • Do not chew or crush, swallow whole.
  • Refrigerate, shake well; discard after (date).
  • Do not drink alcoholic beverages when taking this medication.
  • Do not take dairy products, antacids, or iron preparations within one hour of this medication.
  • You should avoid prolonged or excessive exposure to direct and/or artificial sunlight while taking this medication.

Correct interpretation rates among the 74 interviewed patients for the eight warning labels ranged from 0 to 78.7 percent. The majority of the patients in this study misinterpreted all of the warning labels, with the exception of "Take with food." Researchers determined five common causes for the confusion:

  1. Difficult to follow multiple step instructions. Example: "Refrigerate, shake well, discard after (date)" was understood by fewer than five percent of patients.
  2. Text written at too high a reading level. For example: "You should avoid prolonged exposure or excessive exposure to direct and/or artificial sunlight while taking this medication" is written at a high school level of comprehension and interpreted as "do not leave medicine in the sun."
  3. Use of icons confused many patients.
  4. Misinterpretation of label colors. For example: The color red was interpreted as meaning danger and green viewed as a safe recommendation.
  5. Unclear messages. Example: Labels with "do not chew or crush, swallow whole" were often interpreted as "Don't swallow whole or you might choke."

The researchers recommend that consumers be engaged when developing standards for warning labels to ensure that words, icons, and formatting are useful to all individuals, including those with low literacy.

Downloads and links

AHJP abstract (.doc) (26 KB)

"Health Literacy: A Prescription to End Confusion" executive summary (.pdf) (920 KB)

The full study may be read online for free at: http://www.nap.edu/catalog/10883.html.

Back to News

 

Technical incompetence responsible for majority of surgical errors

A recent review of a closed malpractice claims during a 20-year period shows that 41 percent of surgical errors were caused by a lack of technical competence; 58 percent of those errors were shown to be due to surgeons' lack of experience or skill even within their specialty.

Malpractice claims were studied in a recent review to identify causes of surgical errors and identify opportunities for prevention. Malpractice claims are a significant source of information since most errors identified through claims have caused a severe injury. This analysis was published in the July 2006 issue of Surgery and reviewed covered claims closed between 1986 and 2002, with most closed in 1994 or later.

Because of the depth of care provided and sheer numbers of physicians, the use of malpractice claim data is very valuable to researchers. The body of data to be reviewed in malpractice claims is also larger than in the typical medical record because it includes depositions and confidential investigations. In this study, one quarter of the errors found led to death.

In the study, "Analysis of surgical errors in closed malpractice claims at 4 liability insurers," authors reviewed 444 closed malpractice claims in which patients stated a surgical error occurred. Of the reviewed cases, 58 percent were found to have a surgical error that resulted in a patient injury. Most errors (75 percent) occurred in intraoperative care, with lower percentages in preoperative or postoperative care. Moreover, systems factors were found to have contributed to the errors in 82 percent of the cases. One or more of four systems factors contributed to 68 percent of the errors.

The four systems factors were:

  • Communication breakdowns.
  • Lack of supervision.
  • Technology failures, competency.
  • Patient-related factors.

The main systems error found was inexperience or lack of technical competence and was discovered in 41 percent of the cases of surgical errors; 58 percent of the surgical errors were the result of a surgeon practicing within his specialty but lacking experience or skill with the particular task. Twenty-four percent of the systems errors were found to be the result of a communication breakdown.

The study authors concluded that while they found patient injury from isolated individual errors, the majority of surgical errors were the result of multiple levels of failure. Most involved more than one clinician and almost one-third involved a series of events that crossed multiple phases of care. Strategies to reduce the incidence of surgical errors should be targeted at the most common types of identified failures. Efforts need to focus on increasing the competence of surgeons to safely perform operations with which they have limited experience and implementing measures that reduce communication errors. The study recommends that the review of malpractice claims data can help identify interventions to reduce surgical error and improve the quality of surgical care.

Downloads and links

Surgical errors in closed malpractice claims abstract
(.doc) (25 KB)

Back to News

 

Harvard Patient Safety course for clinicians: Boston, October 23-24, 2006

A comprehensive course on improving patient safety will be held October 23-24, 2006, at the Hilton Boston Back Bay Hotel. The goal of the course is to provide clinicians and other healthcare leaders with information about emerging trends and best practices applicable in their own organizations. Topics will include an introduction to the problem of medical error and its emergence as a public health problem, as well as the nature of error in healthcare, drawing heavily from human factors engineering and systems theory.

For the third consecutive year, this course is supported by the Premier Safety Institute and is sponsored by Dana-Farber Cancer Institute Center for Patient Safety, Brigham and Women's Hospital Department of Medicine and Center of Excellence for Patient Safety Research and Practice, and Beth Israel Deaconess Medical Center Department of Medicine.

The curriculum is designed for practicing physicians, as well as those with an interest in improving patient safety. Participants may include medical educators, medical practice directors, nurses, pharmacists, risk managers, QI professionals, administrators, researchers and specialists in high-risk areas such as oncologists, critical care clinicians, emergency physicians, and hospitalists.

Saul N. Weingart, M.D., Ph.D.; David W. Bates, M.D., M.Sc.; and Hans Kim, M.D., MPH, are the course directors. An experienced faculty includes Sylvia Bartel, RPh; Booker Bush, M.D.; Maureen Connor, R.N., MPH; James Conway; Thomas Gallagher, M.D., FACP; Tejal K. Gandhi, M.D., MPH; Paula Griswold, M.S.; Christopher P. Landrigan, M.D., MPH; Lucian L. Leape, M.D.; Eric Poon, M.D, M.P.H.; Daniel B. Raemer, PhD; Patricia Reid Ponte, R.N., DNSC; Jeffrey Rothschild, M.D., MPH; Benjamin P. Sachs, M.D.; Lawrence N. Shulman, M.D.; Steven R. Simon, M.D., MPH; C. Christopher Smith, M.D.; and Lawrence Studdert, L.L.B., M.P.H., Sc.D.

The fee for the two-day course is $695 ($395 for residents and fellows).

Downloads and links

Additional course information, including a complete faculty listing, agenda, CEUs, and online registration, are available at the conference Web site: http://www.cme.hms.harvard.edu/courses/patientsafety

Download the course brochure and registration form
(.pdf) (112 KB)

Back to News | Back to top

 

Safety tools

Safety A-Z – New resources added: falls, construction, SUDS

Tool text.

Updates are added regularly to the Safety A-Z topics, such as fall prevention, back injury prevention, culture of safety, sharps safety, Clostridium difficile, construction, and more. The latest updates include:

Back to Safety tools

 

JCAHO automated tools – Sentinel event and complaint reporting

The Joint Commission on Accreditation of Healthcare Organizations has a secure extranet Web site that offers new automated tools for reporting sentinel events and complaints. Full transition to the online tools is required by January 1, 2007. Locate the tool on the extranet home page under "Self Report Sentinel Event" in the "Continuous Compliance Tools" section. Root cause analyses (RCA), action plans, and sentinel event measures of success may be submitted to the Joint Commission using an online RCA collection tool, also accessible from the "Continuous Compliance Tools" section under the "Sentinel Event Activities" link. The automated complaint tool is also available on the Joint Commission Web site at: http://www.jointcommission.org/GeneralPublic/Complaint/. Responses to complaints (when required) will be delivered by e-mail and via the extranet home page under "Complaint Response" in the "Continuous Compliance Tools" section.

Back to Safety tools

 

Videos – Construction; ICRA training

The construction and ICRA concept and matrix as described and promoted by the Association for Professionals in Infection Control and Epidemiology (APIC) and the American Society for Healthcare Engineering (ASHE) are available in two training videos. One is directed to healthcare professionals (20 minutes) and one to construction personnel (eight minutes), with availability in English and Spanish. Go to www.EnvisionInc.net. For more information on and resources about construction on Premiers Web site: www.premierinc.com/quality-safety/tools-services/safety/topics/construction/.

Back to Safety tools

 

AHRQ – Patient safety and information technology projects

New materials from the Agency for Healthcare Research and Quality (AHRQ)'s 2006 "Annual Patient Safety and Health Information Technology Conference" describe the various AHRQ-funded patient safety and health information technology (IT) projects across the country. These include implementing new interventions and technologies that improve care, measuring and managing innovations in everyday clinical practice that reduce medical errors, advancing community health through regional health information exchange, and creating a culture of safety across various healthcare settings. Access the materials at AHRQ link.

An AHRQ brochure highlighting important tools and resources for healthcare providers and policymakers is available from AHRQ's portfolio on patient safety (.pdf) (132 KB). The brochure includes information on patient safety culture, the AHRQ Web M & M, and safety research highlights; it also features strategies and tools on team training and resources on information sharing.

Back to Safety tools

 

ACIP – New rotavirus vaccine

The Advisory Committee on Immunization Practices (ACIP) has issued recommendations (.pdf) (197 KB) for preventing rotavirus gastroenteritis in infants and children. The recommendations call for American infants to be immunized with the recently licensed rotavirus vaccine. Infants should receive three doses of the vaccine, administered orally at two, four and six months. It is the most common cause of severe gastroenteritis in infants and young children worldwide. Although rotavirus causes few deaths among U.S. children, almost all children will become infected with rotavirus by age five. Most of them will develop gastroenteritis, resulting in up to 272,000 emergency department visits and 70,000 hospitalizations each year.

Back to Safety tools | Back to top

 

Editorial team

  • Gina Pugliese, RN, MS editor
  • Judene Bartley, MS, MPH, CIC, associate editor
  • John Hall, BSJ, contributor
  • Judith Luca, RN, BSN, contributor
  • Derek Kleckner, CUA, Web master
  • Jena Abernathy, Executive sponsor

About Premier

Premier, Inc. is a healthcare alliance entirely owned by 200 of the nations leading not-for-profit hospital and healthcare systems. These systems operate or are affiliated with 1,500 hospital facilities and hundreds of other healthcare sites. Premier provides an array of resources supporting health services delivery, including clinical and operational comparative data applications for quality/safety performance improvement, group purchasing and supply chain services, and insurance programs. The Centers for Medicare and Medicaid Services (CMS) has recently partnered with Premier for a three-year quality incentive demonstration project. Participating hospitals using Premier’s Perspective Online ™ database can receive recognition and additional Medicare payment when they meet or exceed specific quality measures.

Safety Share © 2006 Premier, Inc.

You may forward this newsletter to your colleagues. If you would like to reprint any of these stories, please cite the "Safety Share newsletter, Premier, Inc." as your source and send an email to safety_institute@premierinc.com and alert us. Thank you.