Premier Safety Share

In this issue

Premier Safety Web site

January 25,  2002

Welcome to the first issue of Premier Safety Share, a web-based e-mail newsletter for healthcare from the Premier Safety Institute. The newsletter will provide easy access to downloadable news-related documents and resources. We hope you will find the information to be timely and beneficial, and we welcome your comments.

Gina Pugliese, Editor
Vice President, Premier Safety Institute



Few hospitals have computerized physician order entry, but many plan to implement

Leapfrog Group has released the initial results of its survey on patient safety. Of 497 urban hospitals in six regions (Atlanta, California, East Tennessee, Minnesota, St. Louis, and Seattle-Tacoma-Everett), 241 hospitals (or 48 percent) responded to the survey on computerized physician order entry (CPOE), specialist staffing in the intensive care unit, and evidence-based hospital referrals.

According to the survey, 3.3 percent of responding hospitals have implemented CPOE and an additional 30 percent plan to do so by 2004. Ten percent reported that intensive care specialists oversee patient care in the ICU at least eight hours a day, with another 18 percent planning to do so by 2004. In the absence of specific outcome data on evidence-based hospital referral, Leapfrog reported that its survey shows "Consumers in most urban areas have a choice of hospitals with extensive experience treating patients needing select high-risk surgeries or neonatal intensive care." Consumers may review the data on hospital referral to find out how often each facility performs specific surgical procedures, including coronary bypass and angioplasty.

Founded by the Business Roundtable in November 2000, the Leapfrog Group is a coalition of more than 90 public and private organizations that provide healthcare benefits and seek to mobilize purchasing power to initiate breakthrough improvements in healthcare safety and to promote consumer healthcare choice. For more information on the survey, go to the Leapfrog Web site.

CPOE is also addressed in two other recent reports. The American Hospital Associationís report, The Challenge of Assessing Patient Safety in America's Hospitals, notes that although CPOE with computerized decision support holds much promise for improving patient safety, there is not yet sufficient evidence to establish CPOE as a standard of care (download report below). The Leapfrog Groupís CPOE: A Look at the Vendor Marketplace and Getting Started provides information to help hospital decision makers organize a CPOE effort and launch a search for an appropriate CPOE solution (download report below).

Downloads and Links

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FDA issues recommendations on blood donors exposed to anthrax or Creutzfeldt Jakob Disease

The Food and Drug Administration has released recommendations for assessing blood donor suitability and blood product safety in the event of exposure to anthrax. The document, Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax, includes recommendations for donor deferral, product quarantine and retrieval, and notification of prior transfusion recipients. While the FDA is soliciting public comment, it is implementing this guidance document immediately due to public health concerns (download FDA Guidance below).

The FDA also updated recommendations intended to reduce the risk of exposure to Creutzfeldt Jakob Disease (CJD) and the human form of "mad cow disease" known as variant CJD (vCJD). The recommendations minimize the possible risk of CJD and vCJD transmission from blood and blood products. The document, Revised FDA Guidance on Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products provides comprehensive guidelines for all registered blood and plasma establishments for deferral of donors at high risk and supersedes documents issued November 1999 and August 2001 (download FDA Guidance below).

Downloads and links

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OSHA delays enforcement of new recordkeeping rule

OSHAís revised recordkeeping requirements took effect on January 1, 2002, but enforcement of the rule will be delayed for 120 days to allow OSHA time for education and implementation. OSHA has said that citations will not be issued during the first three months of 2002, provided an employer is attempting in good faith to meet its recordkeeping obligations and agrees to make the corrections necessary to bring its records into compliance. This final rule, the Occupational Injury and Illness Recordkeeping Reporting Requirements, and related forms issued on October 12, 2001, replaces the rule published in January 2001. It provides new definitions and reporting criteria and requires the use of three new forms, OSHA 300, 300A, and 301, or equivalent forms that adhere to the reporting requirements (download forms below). OSHAís 300 and 301 forms can be used to record contaminated sharps injuries, provided all the requirements of the Bloodborne Pathogen Standard are met, including details of the injury (e.g., device type and brand and description of injury) and the ability to easily segregate the sharps injuries from other injuries.

A compliance directive, OSHA's Recordkeeping Policies and Procedures Manual (CPL 2-0.131), was also issued to provide guidance on how the rule will be enforced (download manual below). Employers with fewer than 10 employees are exempt from these regulations. The rule also delays for one year a previously issued recordkeeping requirement for occupational muscular skeletal disorders (MSDs) or ergonomic injuries; MSDs are recordable only if they meet OSHAís recording criteria for any other type of injury. OSHA continues to work on defining ergonomic injuries and may issue future regulations.

Recordkeeping related to contaminated sharps injuries and other questions on the Bloodborne Pathogen Rule are addressed in the frequently asked questions (FAQs) on OSHA compliance (link to FAQs below).

Downloads and links

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Inspection procedures for bloodborne pathogen rule revised

OSHA recently revised its Enforcement Procedures for Occupational Exposure to Bloodborne Pathogens (CPL 2-2 69) to incorporate sharps injury prevention requirements spelled out in the Needlestick Safety and Prevention Act of 2000 (download CPL below). These enforcement procedures assure consistent and uniform enforcement of the standard. Revisions include all the changes made to the standard, including methods for selection of devices with engineered sharps injury prevention, involvement of non-managerial workers in evaluation and selection process, log of contaminated sharps-related injuries, and annual review of the exposure control plan. Also included are model exposure control plans and updates on the Centers for Disease Control and Prevention (CDC) management of occupational exposures to HIV, HBV and HCV. Frequently asked questions on OSHA compliance with sharps safety are available (download FAQs below).

Downloads and links

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Debate reopens on occupational TB risks

A proposed regulation for preventing occupational exposure to tuberculosis (TB) has been delayed since OSHA issued it in 1997. OSHA announced in the January 24th Federal Register that it is reopening the TB record to obtain public comment on TB risks and the findings of the Institute of Medicine (IOM) Committee on Occupational TB Exposure. Comments are limited to the draft final risk assessment and are due by March 25, 2002.  Additional information is available below (download announcement below).

Critics of the proposed regulation pointed out steady decline in TB cases since the early 1990s, and supporters argued that TB remained a risk to healthcare workers. To address many of the issues raised, the US Congress requested the National Academy of Science to examine the risks of occupational TB among healthcare workers and the possible effects of federal regulations to address this risk. In August 2000, a committee of the Institute of Medicine, the health policy arm of the National Academy of Science, met to review research and data on TB risks and control from a number of groups, including Premierís Safety Institute. Gina Pugliese of Premierís Safety Institute presented results of a national survey, conducted by Premier in collaboration with the CDC, to assess the status of TB control programs in US hospitals. Pugliese reported that more than 95% of US hospitals have isolation rooms that meet the CDC criteria, require workers wear N95 TB respirators, and perform routine TB skin testing on workers (download abstract of Premier-CDC study below).

In its final report, the Institute of Medicine committee concluded that TB remains a threat to some healthcare, correctional facility, and other workers in the U.S. Although the risk has been decreasing, vigilance is still needed. Moreover, the CDC guidelines have been effective and the primary risk to workers now comes from patients or inmates with undiagnosed or unsuspected infectious tuberculosis. The committee also concluded that an OSHA standard on occupational TB could have a positive effect if it met three conditions: (1) was consistent with TB control measures that were effective; (2) increases the level of compliance with those measures; (3) allows flexibility for organizations to adopt TB control measures that are appropriate to the level of risk.

The Centers for Disease Control and Prevention (CDC) is revising the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 1994, that were the basis of OSHAs proposed standard and are used as the standard of practice for TB control measures when enforcing worker protection under the General Duty Clause.

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Reports of wrong-site surgery on the rise

Reported incidents of surgery performed on the wrong site have risen from 16 in 1998 to more than 58 in 2001, according to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The increase has prompted a second Sentinel Event Alert on the topic.

It is not known if this increase is because of greater reporting of these events to JCAHO. However, wrong-site surgery data from the New York Department of Health suggests that there is a significant amount of underreporting to JCAHO. Although the number of reported cases is small compared to the 41 million surgical procedures performed in the US, these events are completely preventable.

The message of the latest Sentinel Event Alert from JCAHO includes the need to mark the surgical site, use verification checklists and documents (eg X-rays), use oral verification in the operating room, monitor compliance, and use active communication techniques for final verification (download Sentinel Event Alert below).

Orthopedic surgery had the greatest opportunity for right-left confusion and was the specialty involved most often in 40 percent of the cases reported to JCAHO. Recognizing this increased risk, the American Academy of Orthopedic Surgeons (AAOS) initiated a campaign in 1997 to have surgeons "sign the surgical site." Recognizing that education of patients is key to prevention, the Agency For Healthcare Research and Quality (AHRQ) developed a patient fact sheet that provides tips about preventing medical errors, including having the physician sign the operative site before surgery (download patient fact sheet below).

Fifty-eight percent of the reported cases to JCAHO occurred in either a hospital-based ambulatory surgery unit or freestanding ambulatory setting. The New York State Department of Health prepared preoperative protocols to prevent wrong-site, wrong-patient, and wrong-procedure surgery (download guidelines below). These guidelines were shared with all New York State hospitals and ambulatory care centers surgery and emphasized three independent verifications and patient-surgeon verbal interaction in the peri-operative area.

Experts agree that a change in the system is needed to prevent these types of errors.

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FDA updates recommendations on cell phones and electromagnetic compatibility

The FDAs Center for Devices and Radiologic Health (CDRH) recently updated its Recommendations for Electromagnetic Compatibility in Healthcare Facilities (download guidelines below). These guidelines were prompted in part by the increased use of cellular and wireless communication equipment in healthcare facilities and the need to minimize risks associated with electromagnetic interference. The recommendations include the assessment of the electromagnetic environment of the facility, identification of areas where critical medical devices are used, coordination of the purchase and management of all electronic equipment, and the reporting of problems to FDA MedWatch program.

The CDRH also maintains a Web site with resources and links to key documents from ECRI, (American National Standards Institute (ANSI), and the Association for Advancement of Medical Instrumentation (AAMI) on electromagnetic compatibility in healthcare facilities and other related issues. Resources include on-site testing for estimated radiated electromagnetic immunity of medical devices to radio frequency transmitters. For more information, visit

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Hospitals for a Healthy Environment announces mercury and waste reduction resources

The Environmental Protection Agency, the American Hospital Association, the American Nurses Association, and Health Care Without Harm recently announced a collaborative effort to assist hospitals in reducing mercury use and minimizing waste. The joint effort, Hospitals for a Health Environment (H2E), is a voluntary program designed to help hospitals enhance workplace safety and promote environmentally friendly practices.

As part of this effort, they have expanded the H2E Web site, adding additional resources, including case studies, model plans and other tools to improve environmental performance. As part of the H2E initiative, the American Hospital Association reconfirmed its commitment in the 1998 Memorandum of Understanding with the EPA to help hospitals eliminate mercury-containing waste from the healthcare waste stream, with a goal of a 33% reduction in all waste generated by the year 2005.

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About Premier

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