Safety Share

December 2004

Dear colleague:

Don't miss the announcement from IHI about the 100K Lives Campaign.

Note: we maintain an archive of every issue of Safety Share for the past three years on our web site.

On behalf of the Premier Safety Institute, we wish you and your loved ones a wonderful holiday season.

Gina Pugliese, editor
Vice President, Premier Safety Institute


Safety tools

IHI Announces the "Save 100,000 Lives Campaign"

Institute for Healthcare Improvement (IHI) CEO Donald Berwick announced the save 100,000 Lives Campaign this week at the IHI National Forum in Orlando. Berwick told the audience of more than 4,000 attendees that IHI will join hands with other leading American health care organizations in launching this unprecedented 100,000 Lives Campaign, which will disseminate powerful improvement tools, with supporting expertise, throughout the American health care system. The Campaign aims to enlist thousands of hospitals across the country in a commitment to implement changes in care that have been proven to prevent avoidable deaths. IHI and other organizations sharing their mission are convinced that a remarkable few proven interventions, implemented on a wide enough scale, can avoid 100,000 deaths between January 2005 and July 2006, and every year thereafter. The six initial interventions in the Campaign include:

  • Deploy Rapid Response the first sign of patient decline
  • Deliver Reliable, Evidence-Based Care for Acute Myocardial prevent deaths from heart attack
  • Prevent Adverse Drug Events (ADEs) implementing medication reconciliation
  • Prevent Central Line implementing a series of interdependent, scientifically grounded steps called the "Central Line Bundle"
  • Prevent Surgical Site reliably delivering the correct perioperative antibiotics at the proper time
  • Prevent Ventilator-Associated implementing a series of interdependent, scientifically grounded steps called the "Ventilator Bundle"

Downloads and links

Additional information about the Campaign, including details about each intervention, useful tools, helpful resources, and how to "sign up" is available at IHI's Web site at:

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OSHA ‘s annual fit-testing for TB on hold for now

Congress just passed a spending bill for 2005 domestic agency funding that includes language prohibiting the Occupational Safety and Health Administration (OSHA) from enforcing the annual fit-testing requirement for respirators used for occupational exposure to tuberculosis (TB). President Bush signed the bill December 9, 2004. Legislative text of the bill states that no funds shall be used to administer or enforce the provisions of the General Industry Respiratory Protection Standard (GIRPS) that require annual fit-testing after the initial fit-testing of respirators for occupational exposure to tuberculosis (TB). Explanatory text that accompanied the bill advises OSHA to take no further action with regard to respiratory protection for occupational exposure to TB until the Centers for Disease Control and Prevention (CDC) completes the CDC TB Guideline revision.

Some hospitals will continue to do annual fit testing

What does this mean for hospitals until the end of the fiscal year, October 2005? This action does not change much in actual practice. Hospitals have long been implementing respiratory protection programs, including initial medical evaluation and fit-testing for tight-fitting particulate respirators (N95s), and annual assessments for tuberculin skin testing. The GIRPS standard added an annual fit-testing component, the only issue addressed by the legislative amendment. OSHA has indicated that it will not cite facilities for not conducting annual fit-testing.

Because this delay language applies only to FY 2005, some organizations may proceed with programs already established for annual fit-testing. Others may continue to follow their current protocols for conducting initial fit-testing followed by annual assessment to determine the need for annual fit-testing on a case-by-case basis.

Interpretations may be different in states with state-approved OSHA plans

Many questions remain, particularly for states with state-approved OSHA-plans, regarding whether this law applies to them. Organizations in states with state-approved OSHA-plans should contact their state OSHA office to verify interpretation.

CDC requests comments on the draft TB Guidelines

There is a sense of urgency to complete the revision of the CDC's TB guidelines because Congress recommended that no action be taken until these guidelines are completed. The CDC draft Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings 2005 referenced by Congress were published in the Federal Register December 6, 2004. Comments are due back to CDC by February 3, 2005.

The review of the CDC guidelines provides an opportunity to review the entire issue of respiratory protection for all biologic agents, including TB. A recent CDC-hosted meeting in November brought stakeholders together to discuss these issues.

Downloads and links

Legislative text - FY05 Bill amendment (.pdf) (25 KB)

Draft TB guidelines (web page)

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Five years after IOM, consumers remain worried about healthcare safety

Five years after the Institute of Medicine's landmark 1999 report on medical errors, "To Err is Human: Building a Safer Health System," which focused attention on medical errors in hospitals, many Americans in a recent national survey said that they do not believe that the nation's quality of care has improved. Forty percent of survey responders say the quality of healthcare has worsened in the past five years; only 17 percent say the quality of care has gotten better and 38 percent say it has stayed the same. These findings were the result of a telephone survey conducted by the Henry J. Kaiser Family Foundation, the U.S. Agency for Healthcare Research and Quality (AHRQ) and the Harvard School of Public Health.

The survey of 2,012 polled adults also found that nearly half of U.S. residents say they are concerned about the safety of the medical care that they and their families receive, and 55 percent say they are dissatisfied with the quality of healthcare in this country - up from 44 percent who reported similarly in a survey conducted four years ago. The survey found that people with chronic health conditions are considerably more likely than other consumers to express concerns about their quality of care and report having personal experiences with medical errors. A summary of the extensive survey may be downloaded below.

AHRQ worked with the Centers for Medicare & Medicaid Services (CMS) and other federal partners to develop a document called Five Steps to Safer Health Care. The document includes precautions patients and their families can take to reduce their risk of experiencing medical errors. A chart pack includes the key survey findings, charts and the questionnaire.

An Institute for Healthcare Improvement (IHI) panel discussion that included patient safety experts explored progress made in patient safety since the Institute of Medicine's 1999 report. The IHI panel concluded that while significant strides have been made in the five years since the report, much more needs to be done to make healthcare safer. Participants in the IHI event included three authors of the IHI report. A transcript of the discussion is available. To promote continued progress, the panelists called for: uniform and clearly defined patient safety goals and evidence-based measures to reach them; patient safety training in medical and nursing school curricula; more robust voluntary and mandatory public reporting; financial incentives for investing in health information technology; and reforms to encourage more open discussion about errors.

Downloads and links

Survey summary (.doc) (35 KB)

Five steps to safer healthcare (.pdf.) (360 KB)

Chartpack - questionnaire, survey results and charts (.pdf) (330 KB)

IHI panel transcript (.pdf) (192 KB)

The webcast, complete survey findings and related resources are available at:

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Leapfrog survey reveals need for improvement in NQF safety practices

More than 1000 hospitals responded to The Leapfrog Group's survey measuring hospitals' progress toward reaching the group's patient safety goals. Survey results show that only 21 percent of hospitals are fully compliant with 27 safety practices developed by the National Quality Forum. Eighty percent indicated they have implemented procedures to avoid wrong-site surgeries, and 70 percent now require a pharmacist to review all medication orders before medication is given to patients. However, 70 percent did not have an explicit protocol to ensure adequate nursing staff, 50 percent did not have procedures in place to prevent pressure ulcers and 40 percent lack policies requiring workers to carry out hand hygiene before and after seeing a patient. Approximately 20 percent of respondents have fully implemented computerized physician order entry (CPOE) or plan to do so by 2006. The survey measures hospitals' use of CPOE, referral of patients for certain high-risk procedures based on volume, staffing of intensive care units with specially trained physicians, and implementation of the National Quality Forum's patient safety practices. Consumers can locate more information by searching The Leapfrog Group's Web site.

Downloads and links

The Leapfrog Group press release (.pdf) (50 KB)

More information is available by searching the Leapfrog safety results at:

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CMS, JCAHO release clarification on AMI measure for angiotensin

New literature and anticipated guidelines by the American College Cardiology/American Heart Association regarding the incorporation of angiotensin receptor blockers (ARBs) into clinical practice have led to concerns about their impact on current required acute myocardial infarction (AMI) measures. This has spurred clarifications from the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Those clarifications affect measures AMI-3 and HF-3, which address angiotensin converting enzyme inhibitor (ACEI) for left ventricular systolic dysfunction (LVSD). As a result, the CMS/Joint Commission Technical Measures Workgroup approved a two step-plan of implementation to address the evolving evidence for the use of ACEI and ARB drugs in the treatment of patients with heart disease.

A joint clinical fact sheet has been prepared by JCAHO and by the Colorado Foundation for Medical Care, and the Medicare Quality Improvement Organization for Colorado, under contract with CMS. The fact sheet includes the clinical rationale for the change, a description of the two-step implementation plan, questions and answers, and the references that support the change. Release notes 1.01 for the National Hospital Quality Measures Specifications Manual effective with January 1, 2005 discharges will appear on the JCAHO Web page and will incorporate the changes as outlined in the fact sheet.

Downloads and links

Joint clinical fact sheet (.pdf) (468 KB)

Download the specifications manual and release note:

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FDA issues guidance for safe processing and use of human tissues for grafts

The U.S. Food and Drug Administration (FDA) recently issued a final regulation to provide additional safeguards for manufacturing human tissue such as musculoskeletal grafts and corneas. The rule, entitled "Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Establishments," takes effect May 25.

The rule requires manufacturers that recover, process, store, label, package, and distribute tissues to use safeguards to prevent introduction or transmission of infectious agents. Hospitals and surgery centers would fall under the rule only if they procure and "manufacture" tissue but not if they simply transplant tissue. The rule also requires the tissues to have a unique identifying code that can be tracked from the donor to the consignee, and that significant adverse reactions and manufacturing deviations are reported to the FDA. To date in 2004, there have been about one million tissue transplants, up from 350,000 in 1990. The recently released regulations are the last of three sets defining federal industry standards. In January, the agency required all tissue banks to register with the FDA and to allow for regular inspections. In May, the FDA said tissue donors, like blood donors, must be screened for infectious diseases. It also required tissue banks to test donors and donated tissue for infectious agents or diseases, including HIV, hepatitis B and C, syphilis and Creutzfeldt-Jakob disease- the human form of mad cow disease. A press release with links to the rule and questions and answers is available.

Downloads and links

Press release (.doc) ( 32 KB)

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Radio frequency identification technology emerges to reduce risk of wrong–site surgery

Radio-frequency identification (RFID) is a new technology that may help reduce surgical and medical errors. RFID tags, which can be read by a transmitter, can identify the correct surgery site, detail patient allergies, and provide information about prior treatment.

The U.S. Food and Drug Administration (FDA) has recently approved the marketing of radio frequency identification chips from two manufacturers for use in surgical patients.

One such system employs a tag, which is labeled with an integrated passive transponder, an encoder that reads the chip, and a printer. The patient's name and surgical site are printed on the SurgiChip™ tag. The inside of the tag is encoded with the surgery date, the type of procedure and the surgeon's name. The tag is scanned with a desktop RFID reader for confirmation by the patient and is then placed in the patient's hospital file. On the day of surgery, the tag is removed from the file and scanned again, and the patient verifies the encoded information. The tag, which has an adhesive backing, is then placed on the patient's body near the surgical site. In the operating room, the tag is again scanned and the encoded information is verified with the patient's chart. The tag is removed just before surgery and returned to the patient's hospital file.

Another FDA-approved system - the VeriChip™ - is based on a subcutaneous RFID chip encoded with a 16-digit number read by a nearby scanner. The code unlocks the patient's entry in a secure database that would contain medical information, including allergies and notes from prior treatment.

The chips' makers think they offer a number of benefits. In addition to providing an additional safeguard against medical errors, emergency-room doctors could scan a device and quickly determine vital information about an unconscious patient.

On a related topic, the FDA has announced drug counterfeiting RFID initiatives. In its February 2004 report, "Combating Counterfeit Drugs," the FDA said RFID was an important technology in ensuring the long-term safety and integrity of the U.S. drug supply.

Downloads and links

More details on RFID implementation (.doc) (44 KB)

FDA surgical marker information:

FDA February 2004 report, "Combating Counterfeit Drugs"

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Regulators agree on alcohol-based hand rub dispensers in hallways

A regulation prohibiting the placement of alcohol-based hand rubs in exit corridors is expected to be lifted within weeks. According to a letter from Centers for Medicare and Medicaid Services (CMS) to the Association for Professionals in Infection Control and Epidemiology (APIC), a new CMS regulation will promote rather than prohibit the placement of alcohol-based hand rubs in exit corridors. Convenient access to alcohol-based hand rubs is a key issue to enhance compliance hand hygiene for infection prevention.

APIC, along with many other stakeholders, had been urging the National Fire Protection Agency (NFPA) and CMS to revise codes and laws that prohibited hallway placement of alcohol-based hand rub dispensers because of undocumented risk of fire. NFPA has already modified their codes to permit hallway placement and CMS was expected to adopt these modified NFPA codes.

CMS has now indicated that an interim final rule with comment period to address this issue is scheduled for publication in the Federal Register Dec. 23, 2004 with a proposed effective date of February 23, 2005.

Currently, states have varied in their approach to enforcing hallway dispenser placement. Because the revised regulation is expected to be in place by February 2005, in the interim, healthcare organizations that may be cited for hallway placement should consider requesting a "temporary waiver" from enforcement action in their plan of correction.

A study commission by the American Society for Healthcare Engineering (ASHE) showed minimal risk of fire from hallway placement of alcohol-based hand rubs. This study served as the foundation for the revisions of the codes and laws. Additional background on the issues is available from a summary published by the Safety Institute in 2003.

Downloads and links

Press release on CMS letter (.pdf) (18 KB)

Additional information on the issue is available from the Safety Institute's Hand hygiene module.

Details of the ASHE study and dispenser placement recommendations are available from ASHE at:

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Hospital nurse performance measures released by NQF

The National Quality Forum (NQF) has released a report that details 15 voluntary nursing-sensitive consensus standards for hospitals to use in evaluating nursing performance. This is the first set of national standardized performance measures to assess the extent to which nurses in acute care hospitals contribute to patient safety, healthcare quality, and a professional work environment. The report describes the 15 standards endorsed by the NQF, how to implement them, and priorities for research. Listed in three categories, the standards provide the public with a way to assess the quality of nursing inpatient care. The standards also help providers identify critical outcomes and processes of care, and can be used by purchasers to reward hospitals that have high performing nursing services.

The NQF report recommends that hospitals analyze these measures at the unit level to allow staff nurses to view their work over time. Individual units should define each measure for their specific use. The three categories are: 1) eight patient-centered outcome measures; 2) three nursing-centered intervention measures; and 3) four system-centered measures.

Downloads and links

Download the complete set of nursing performance measures (.pdf) (1.8 MB)

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Safety tools

CDC flu resources - masks, new FAQs

The CDC recently issued interim guidance on the use of masks (.pdf) (104 KB) and other prevention techniques, and provided new "frequently asked questions" regarding the nationwide allocation of the influenza vaccine. The updated information is available at:

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Patient safety video - First Do No Harm: Part 3

Partnership for Patient Safety (p4ps) has released First, Do No Harm™, Part 3: Healing Lives, Changing Cultures, the newest in its video series of case-based patient safety learning tools. Premiered in November 2004, Part 3 completes the story of how a healthcare community learns from systems failure, makes lasting changes to achieve high reliability operation, creates just organizational cultures that professional staff trust, and acts quickly to meet the needs of patients and families before a lawsuit is filed. Key issues explored include whether to apologize as part of a disclosure process, building teams and fostering leadership on patient safety issues at multiple levels in the healthcare organization, and how to manage media attention triggered by a sentinel event. To celebrate the introduction of First, Do No Harm™ Part 3: Healing Lives, Changing Cultures, each part in the series is being offered at the reduced price of $595 (a $200 savings) through January 31, 2005. For ordering and more information, go to:

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New, free resources - Safety Store adds exposure prevention book; EPP program CDs

A free copy of the book, "Preventing Occupational Exposures to Bloodborne Pathogens," a collection of articles from Advances in Exposure Prevention (1994 to 2003), is available from the Premier Safety Store. This 235-page book is edited by Jeannie Jagger and Jane Perry from the International Healthcare Worker Safety Center at the University of Virginia.

Premier's Safety Institute is also offering a four-CD set containing all the presentations from "Environmentally Preferable Purchasing and Healthcare Practices Conference" held in Boston, April 29, 2004. Topics include green buildings, mercury elimination, recycling medical waste processing, solvent recovery, and more. Order free copies of the book and CDs from the Premier Safety Store at:

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FDA resources - New FAQ on single-use devices

The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released a new FAQ on single-use devices. The document, titled, "The Guidance for Industry and FDA Staff: Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter," (.pdf) (140 KB) explains instances in which a NSE letter pertains to a reprocessed SUD and whether in-stock, reprocessed SUDs can be used once the reprocessor can no longer distribute the SUDs as a result of a NSE letter.

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Perinatal hotline - Expert HIV-infection consultation supported by HRSA

A new telephone hotline that provides clinicians with immediate access to expert advice on treating HIV-infected pregnant women and their children is available through the federal Health Resources and Services Administration's National HIV/AIDS Clinicians' Consultation Center at San Francisco (CA) General Hospital. The Perinatal Hotline (888.448.8765) provides 24-hour consultation from HIV experts, including advice on interpreting HIV testing in pregnancy and implementing the U.S. Public Health Service's clinical care guidelines. More information is available from:

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Editorial team

  • Gina Pugliese, RN, MS editor
  • Judene Bartley, MS, MPH, CIC, associate editor
  • John Hall, BSJ, contributor
  • Judith Luca, RN, BSN, contributor
  • John Deem, managing editor
  • Derek Kleckner, BA, Web master

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.