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January 2003

Dear Colleague:

We hope you enjoy our free safety newsletter.

It has been one year since we published the first issue of Safety Share and you are among the more than 10,000 subscribers to date. The full year of individual issues is archived on the Safety Institute Web site with all of the resources available any time you need the information.

Please continue to share with your colleagues and encourage them to subscribe so they don't miss any issues.

Happy New Year!

Sincerely,

Gina Pugliese, Editor
Vice President, Premier Safety Institute

News

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SSM Health Care wins the Baldrige Quality Award: a healthcare "first"

SSM Health Care (SSMHC), a St. Louis-based not-for-profit health system of hospitals and other health-related organizations, became the first healthcare organization in the country to be awarded a Malcolm Baldrige National Quality Award. SSMHC was one of 17 healthcare institutions to apply for the Baldrige.

"The Baldrige model," said Sister Mary Jean Ryan, F.S.M., president/CEO, SSM Health Care, "has been instrumental in helping us achieve our mission, because we have been using it for seven and a half years to improve the care we provide to those we serve." Although the MBNQA is a significant milestone, the award is only one component of SSMHC’s ongoing 12-year continuous quality improvement (CQI) program, which involves both system-wide and individual organizational efforts. For more information, see the SSMHC news release.

The winning application has been generously shared by SSMHC; plans and results may be viewed and downloaded in eight files at the SSM Health Care Web site. The files summarize facets of the award application, including:

  • Organizational profile
  • Leadership
  • Performance management and measurement results
  • Timeline of the strategic financial and human resources planning process used to achieve their goals.

Congress established the MBNQA in 1987 to recognize U.S. organizations for their achievements in quality and business performance, and to raise awareness about the importance of quality and performance excellence as a competitive edge. Winning organizations are considered world-class role models in their industries. The U.S. Department of Commerce National Institute of Standards and Technology (NIST) manages the Baldrige National Quality Program and is traditionally presented by the President of the United States. Each year, the Commerce Department selects up to three organizations in manufacturing, service, small business, education, and healthcare for the awards. The award is the top honor a U.S. company can receive for quality management and quality achievement in the U.S.

Downloads and links

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Effort underway for reporting quality data consistent with new IOM report

The American Hospital Association (AHA), the Federation of American Hospitals (FAH), and the Association of American Medical Colleges (AAMC) are launching a national voluntary initiative to collect and report hospital quality performance information. This effort is one component of an overall initiative to make information about hospital performance accessible to the public and to invigorate quality improvement efforts. Voluntary reporting is an essential first step. See the AHA quality advisory.

The goals of the effort are to:

  • Provide useful and valid information about hospital quality to the public.
  • Give providers a sense of predictability about public reporting expectations.
  • Standardize data collection priorities and mechanisms.
  • Support physicians and other clinicians in their ability to provide quality care to patients.
  • Enhance hospitals’ efforts to improve the care they deliver.

Supporters of this initiative – The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the National Quality Forum (NQF), the Centers for Medicare & Medicaid Services (CMS), and the Agency for Healthcare Research and Quality (AHRQ) – will provide technical assistance in developing and identifying quality measures. Additionally, they will help making the information accessible, understandable, and relevant to the public.

Over time, public reporting is anticipated to empower consumers to make more informed decisions about their care. Valid, reliable, comparable, and salient quality measures have been shown to provide a potent stimulus for clinicians and providers to improve the quality of the care they provide. This voluntary reporting initiative is a significant step toward more informed public and sustained healthcare quality improvement.

This initiative is also anticipated to influence the ongoing quality efforts of the sponsoring organizations, as well. With the support of JCAHO and NQF, AHA, FAH, and AAMC plan to align their quality measurement and improvement efforts to be more effective and efficient as they work together to improve healthcare. This initial voluntary reporting collaboration will provide a foundation for the future use of NQF-endorsed measures.

To get started quickly, hospitals are encouraged to leverage 10 JCAHO/CMS-developed, NQF-endorsed measures for immediate public reporting. Future priorities and measures will be addressed in the recently issued report from the Institute of Medicine (IOM) identifying 15 to 20 other priority areas for quality improvement. This report published January 7, 2003, may be read online. Measures will be drawn from those areas endorsed by the NQF; measures will be sought that respond to the six aims set forth in IOM’s Crossing the Quality Chasm. An entire spectrum of stakeholders will be engaged to work toward focusing national public reporting of hospital performance on agreed-upon priorities and NQF-endorsed measures. More detail on the initial measures is described in the AHA’s fact sheet and the Health and Human Services (HHS) press release.

Downloads and links

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All healthcare facilities have device recall policies; not all assign responsibility

According to a recent ECRI survey, 58 percent of responding facilities said they had reviewed their recall policy during the last year. Of those facilities, 36 percent made changes to their recall policy. Overall, all the facilities responding to the survey had a written policy for handling medical device recalls, and 85 percent of the healthcare facilities’ recall policies named a medical device recall coordinator; 15 percent did not. Risk managers are most likely to be designated the recall coordinator. Of those facilities with recall coordinators, 41 percent said the individual was from risk management, 35 percent designated a materials manager, and 18 percent named someone from clinical engineering.

Surprisingly, 40 percent of facilities responding to the survey do not conduct staff training on their medical device recall policy. Of the 60 percent that do offer training, the majority said it is provided annually. The February 2003 issue of ECRI’s Risk Management Reporter will have complete results from the survey. To purchase a copy, contact circulation@ecri.org.

Downloads and links

  • The February 2003 issue of ECRI’s Risk Management Reporter will have complete results from the survey; to purchase a copy, contact circulation@ecri.org.

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Smallpox vaccination planning underway; some remain wary

Healthcare facilities have intensified planning since the December 13, 2002 announcement of a final, national smallpox vaccination strategy. The U.S. Department of Health and Human Services (HHS) is forming with state and local governments volunteer Smallpox Response Teams to provide critical services to their communities in the event of a smallpox attack. To ensure that Smallpox Response Teams can mobilize immediately in an emergency, healthcare workers and other critical personnel are being asked to voluntarily receive the smallpox vaccine. The federal government is not recommending vaccination for the general public at this time.

The U.S. Department of Defense (DOD) is vaccinating certain military and civilian personnel who are or may be deployed in high threat areas. Some U.S. personnel assigned to certain overseas embassies will also be offered vaccination.

The U.S. Food and Drug Administration (FDA) has begun considering the impact of smallpox vaccination on blood safety. On December 31, 2002, the FDA issued its Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients. This guidance document provides current recommendations for assessment of donor suitability, and for quarantine and retrieval of blood and blood products from donors exposed to the vaccinia virus (the virus used in smallpox vaccines). The presence of vaccinia virus in transfused blood or plasma could be harmful to some recipients. The presence of vaccinia virus in blood (viremia) has rarely been documented, and this potential condition has not been assessed using modern laboratory techniques. Therefore, the risk of transmission of vaccinia virus by blood and blood products is uncertain. Details on donor deferment are also available in the guidance document.

The United States currently has sufficient quantities of the vaccine to vaccinate every single person in the country in an emergency. The smallpox vaccine, which was routinely administered to Americans until 1972, is a highly effective protection against the disease when given before or shortly after exposure to the virus. Pre-attack vaccination of Smallpox Response Teams will allow them, in the event of a smallpox attack, to immediately administer the vaccine to others and care for victims.

The Centers for Disease Control and Prevention (CDC) continues to provide pertinent information and practical resources to assist facilities in their planning via Web casts. In December, the CDC held two Web casts:

  • December 5 and 6: A two–part Web cast titled "Smallpox Preparedness and Response." The presentation assisted state and local health department and clinical personnel in establishing public health and healthcare response teams. It also dealt with planning for smallpox vaccination delivery, administration, and follow-up. The slides from the presentations (in pdf or PowerPoint) can be viewed without downloading the entire Web cast. Questions from participants of this session were answered and posted on the Web site. Q&As addressing the vaccination program, published December 26, 2002, are also available for download.
  • December 20: A Web cast titled "Smallpox Preparedness: Considerations for Response Team Volunteers." This Web cast (scheduled for rebroadcast January 9, 2003) addressed several key issues arising from the Q&As of the December 5 and 6 presentations. Julie Gerberding, Director of CDC, addressed vaccine administration, site care, and issues of liability and compensation. Dr. Gerberding clarified distinctions between workman’s compensation and the liability provisions of the Homeland Security Act (Section 304) as applied to the manufacturers and administrators of the program. She noted that HHS and CDC are identifying the gaps between what exists in states today and what changes are necessary to make this program work for the volunteers. Dr. Gerberding urged participants to review the specific Q&A on Section 304 of the Homeland Security Act, including a flow diagram outlining the provisions of Section 304. She also urged viewers to check the site frequently, as the CDC plans to update it with new information as issues are clarified by the U.S. Department of Justice, the agency with jurisdiction over clarification and scope of the Homeland Security Act.

Additional information may be obtained from a new HHS Web site launched to answer questions about smallpox and the president's vaccination plan.

Downloads and links

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Group urges FDA not to regulate open, but unused single-use devices

Several groups within the healthcare industry, including the American Hospital Association (AHA), have urged the U.S. Food and Drug Administration (FDA) not to regulate the reuse of "Opened But Unused Single-Use Devices" (OBU SUDs). The FDA currently has no regulations regarding the reuse of OBU SUDs. In a response to the FDA's August 28, 2002 request for comments, the AHA said that it had conducted a survey of nearly 700 hospitals, and found that 75 percent of them discard OBU SUDs. Of hospitals that reprocess the devices, most send them to a third-party reprocessor. No hospital reported any adverse patient events related to OBU SUDs. Joining the AHA in this initiative is the American Society for Healthcare Central Service Professionals, the Association of Professionals in Infection Control and Epidemiology, and the Federation of American Hospitals.

Downloads and links

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Overdose of oncology drug prompts ISMP alert

The Institute for Safe Medication Practices (ISMP) issued an alert regarding cases of accidental daily administration of oral methotrexate, an often-used oncology drug, where weekly dosing is intended. The ISMP officials said in the past month the organization learned of two cases of methotrexate overdosing, one fatal and the other resulting in an apparent permanent disability. The alert says mistakes occur because relatively few medications are dosed on a weekly basis. Clinicians and patients are much more familiar with daily dosing of medications. Because of the number of fatalities caused by errors with oral methotrexate, the ISMP said clinicians should consider it a "high alert" medication regardless of the indication. The organization said that as a safety practice, prescribers should include specific clinical indications within prescription directions. As a final quality control check, pharmacists should always review prescription labels with the patient or caregiver to assure accuracy.

Downloads and links

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Physicians, public agree on medical error importance, differ on reduction strategies

A study published in the New England Journal of Medicine and conducted in response to the Institute of Medicine’s (IOM) report on medical errors describes how physicians and the public perceive medical errors. The study, titled Views of Practicing Physicians and the Public on Medical Errors, reports several results that have implications for national efforts to reduce medical errors. While significant percentages of practicing physicians and the public reported personal experience with medical errors, neither group viewed it as one of the most important problems in healthcare today. Instead, physicians describe the most important problems as the cost of malpractice insurance and lawsuits followed by healthcare costs and problems with insurance companies and health plans. The public says the most important problems are healthcare costs and prescription drugs prices.

Additional areas where the views of practicing physicians and the public diverged include their beliefs about the effectiveness of measures taken to reduce the incidence of errors. The public believes a range of proposals would be more effective. Physicians see only two strategies as being very effective: requiring hospitals to develop systems for preventing medical errors and increasing the number of nurses in hospitals. Physicians view the reporting of medical errors with skepticism and feel they should be kept confidential, while the public supports reporting and feel that such reports should be publicly available.

A key point in the IOM report is that errors should be viewed as failures of institutional systems rather than the failure of individuals. The public believes that persons responsible for errors with serious consequences should be sued, fined, and subject to suspension of their professional licenses. The study concludes by noting that perhaps the most important issue is the need to convince physicians that the proposed strategies will reduce preventable medical errors and the harm they cause.

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Safety tools

 

Web-based tool — New modules designed to cut medication errors

A set of tools designed to reduce medication errors and help hospitals take a system-based approach to address such errors was released at the 37th American Society of Health-System Pharmacists Midyear Clinical Meeting. The tools, called Pathways for Medication Safety, were developed by the American Hospital Association’s Health Research and Educational Trust, and the Institute for Safe Medication Practices, with support from The Commonwealth Fund. Organized in a modular format to suit different organizations and professionals, the three main Pathways components can: (1) help hospital leaders and professionals incorporate medication safety into their organization's strategic plan; (2) identify specific error-prone processes and devise safe alternatives using process flow diagrams, case scenarios, and the Institute for Safe Medicine Practices’ "10 Key Elements of Medication Use System;" and (3) prepare to implement a bedside bar-coding system for administering medications.

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Videos, poster, and more — New OR safety Web site

A new safety Web site focused on surgery, www.orprecautions.com, is now available. The site provides safety resources, injury and exposure data, industry information, information about the Needlestick Safety Act, and convenient links to much more OR safety information. Safety and compliance resources on this site include federal and Occupational Safety and Health Administration (OSHA) compliance for the OR, safety handbooks, videos and posters, consulting and speaking resources, on-site training seminars, and administrative and risk management strategies.

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New VIS form — CDC’s latest smallpox vaccination information

The Centers for Disease Control and Prevention (CDC) issued a "Vaccine Information Statement" (VIS) for smallpox vaccine on December 11, 2002. It is important to note that unlike other VIS, the smallpox VIS must be used with a separate consent form that requires a signature.

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Assessment tool — Bed safety evaluation guide

The U.S. Food and Drug Administration’s Hospital Bed Safety Workgroup (HBSW) was formed to review ways that reduce the risk of entrapment and injuries related to hospital beds. The HBSW is focusing on bed rails with: standardized definitions; standardized evaluation of beds, mattresses and side rails; and outreach communications to providers and patients. The HBSW is compiling tools to help reduce the potential for entrapment in hospital bed systems. Available documents come from various sources. For example, the Veterans’ Administration has developed a guide describing the seven entrapment zones and procedures for evaluating each, plus the seven bed safety zones and measurement criteria assigned to each zone letter. The HBSW Web site contains additional information on bed safety, as well as the minutes from Workgroup meetings. A brochure on bed safety that provides information to patients, families and health professionals is available as well.

The FDA expects to publish a guidance document in the Federal Register when all the information is complete. It should be noted that the American Society of Healthcare Engineers (ASHE), in critiquing cost/benefits aspects of this document, expressed reservations concerning the costs of implementing all suggested steps in acute care compared to long-term care facilities. (See Inside ASHE 2002. 10 September (7): 22-4).

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Brochures, posters — Sample OR guides to help identify correct surgery sites

Increased attention to medical errors and patient safety as they relate to correct surgery sites is leading institutions to develop guides and other instructional materials to help reduce such errors. The Veterans Health Administration (VA) has taken steps to ensure that surgical procedures are performed on the correct patient, at the correct site, and, if applicable, with the correct implant. "Correct site" is defined as the correct side and the precise anatomical location as indicated in the consent. A specific directive, including rationale and references, is available, as well as a brochure and a poster that illustrates the steps that are necessary to ensure correctness.

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Editorial team

Gina Pugliese, RN, MS editor
Judene Bartley, MS, MPH, associate editor
Donna Bernstein, MPH, marketing consultant
Derek Kleckner, BA, Web master

About Premier

Premier, Inc. is a national strategic alliance of leading hospitals and healthcare systems representing more than 200 not-for-profit owners that own, operate, or are affiliated with approximately 1,600 facilities. Premier  members  have access to a wealth of resources that support them as they evolve into integrated delivery systems and improve community health across the continuum of care.  Premier maintains corporate offices in San Diego, CA; Charlotte, NC; Chicago, IL; and Washington, DC. For information, visit www.premierinc.com.

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