Issues & Legislative Committee Report

December 14, 2004

Disaster Preparedness

Funding and Educational Opportunities for Materials Managers

Trust for America's Health issues a nonpartisan public health watchdog, issued its 2004 report, “Ready or Not? Protecting the Public’s Health in the Age of Bioterrorism”, on the nation’s ability to respond to the bioterrorist threat. Trust for America's Health measured each state's public health readiness based on 10 indexes, including spending on biological terrorism defenses and emergency planning. The reports states are still struggling to meet basic preparedness requirements and have inadequate resources to juggle the competing health priorities they face. Only six states have achieved “green” status for the Strategic National Stockpile, which means being recognized as adequately prepared to administer and distribute vaccines and antidotes in the event of an emergency. One of the four recommendations is to use practice drills to assess capabilities and vulnerabilities. Material Managers should be aware of local practice drills to use these opportunities to identify and improve their disaster plans. These drills also provide Material Managers an opportunity to assist local emergency operations personnel in better understanding the medical material supply chain.

The National Center for Environmental Health (NCEH), Division of Emergency and Environmental Health Services (EEHS), Environmental Public Health Readiness Branch (EPHRB) has developed an all-hazards public health emergency response guide to address this need. Public health professionals within these departments should have immediate access to guidance and information that will assist them in rapidly establishing priorities and undertaking necessary actions during the response to an emergency or disaster. Several areas in the guide will assist Material Managers in the development of their response planning. The guide can be obtained from the CDC Web Site at http://www.bt.cdc.gov/planning/responseguide.asp.

Radio Frequency Identification (RFID)

FDA Encourages Use of RFID to Help to Combat Counterfeiting Drugs

The biggest news this month was an announcement the Food and Drug Administration (FDA) which encouraged the use of RFID in helping to combat counterfeiting drugs. They issued what is called a Compliance Policy Guide (CPG) which outlines RFID feasibility studies and pilot projects. It also created an internal “RFID Workgroup” at FDA to monitor adoption of RFID in the pharmaceutical chain. Three companies Pfizer, Glaxo Smith-Kline and Purdue Pharma were recognized for their initiatives. Pfizer will put RFID tags on bottles of Viagra possibly as soon as 2005, Glaxo said they will be rolling out RFID in the next 12 -18 months and Purdue said they will be putting the tags on bottles of OnyContin.

Source: http://www.fda.gov/bbs/topics/news/2004/NEW01133.html

Mobile Assets Announces “One System of Care” for Asset, Inventory Management, and Patient Tracking

Mobile Assets, who I’ve reported on before, announced a new system that combines asset tracking, inventory management cabinet, and patient tracking system called One System of Care. Mobile assets has shown a supply cabinet that uses RFID to track inventory and interface with the billing and materiel systems on high cost items such as stents and implantables. This new system uses high frequency 13.56 MHz as the company feels this offers the least chance of radio interference with other medical equipment. The patient tracking system uses an RFID tag enabled patient wristband which allows real-time tracking of patients within a specified area. The second component is a mobile drug dispensing cart that validates patient ID off the wristband and then interfaces with the hospital order-entry system to ensure the right patient is getting the right drug in the right dosage with no drug reaction or allergy conflicts. The Asset Tracking uses RFID system uses fixed readers throughout the facility that detect when tagged assets pass by and provide specific location information on specific pieces of equipment. The integrated system allows supervisors to assign staff tiered access privileges.

Source: http://www.rfidjournal.com/articl/articleprint/1273/-1/1/

Quality/Medication Errors

The MEDERRORS Library

The library at www.MEDERRORS.com contains a unique collection of article summaries on all subjects related to medication errors, including the incidence and cost of medication errors, error reporting and prevention programs, and the application of industrial quality assurance techniques to the health care industry. Collectively, the articles review and summarize decades of research published in leading medical journals and newspapers, including JAMA, The New England
Journal of Medicine, the American Journal of Health-System Pharmacy, and The
New York Times.

“Florida PT Reducing Medical Errors: Creating a Culture of Safety”
Online Course

Nursing Continuing Education Course ME 4007810, authored by Nancy Evans, BS, and Lauren Roberston, BA, MPT, is approved by the Florida Physical Therapy Association. It meets the Florida requirement for prevention of medical errors for physical therapists (Florida Statute Rule No. 64B17-9), for initial licensure and biennial renewal. Accreditation of this course does not necessarily imply the FPTA supports the views of the presenter or the sponsors. 2.5 contact hours are offered.

Source: http://www.nursingceu.com

Types of Medical Errors

An IOM report defines an error as "the failure of a planned action to be completed as intended (an error of execution) or the use of a wrong plan to achieve an aim (an error of planning)." Research on medical errors tends to focus on the medical and nursing professions, although practices that lead to medical error are clearly not limited to those professions. Physical therapists engage in many of the same practices and are subject to the same conditions that are known to cause medical errors.

Research on the reasons that humans make errors (Reason, 1990) has identified two types of errors: active and latent. Active errors tend to occur at the level of the individual, and their effects are felt almost immediately. Latent errors are more likely to be beyond the control of the individual, and include errors in system design, faulty installation or maintenance of equipment, and organizational flaws. The effects of latent errors may not appear for months or even years but they can lead to a cascade of active errors that ends in catastrophe

Learning from Failure in Health Care: Frequent Opportunities,
Pervasive Barriers

The notion that hospitals and medical practices should learn from failures, both their own and others’, has obvious appeal. Healthcare organizations that systematically and effectively learn from the failures that occur in the care delivery process, especially from small mistakes and problems rather than from consequential adverse events, are rare. This article explores pervasive barriers embedded in healthcare’s organizational systems that make shared or organizational learning from failure difficult and then recommends strategies for overcoming these barriers to learning from failure, emphasizing the critical role of leadership. Firstly, leaders must create a compelling vision that motivates and communicates urgency for change; secondly, leaders must work to create an environment of psychological safety that fosters open reporting, active questioning, and frequent sharing of insights and concerns; and thirdly, case study research on one hospital’s organizational learning initiative suggests that leaders can empower and support team learning throughout their organizations as a way of identifying, analyzing, and removing hazards that threaten patient safety. Send all correspondence to Dr. A.C. Edmondson, Harvard Business School, Harvard University at aedmondson@hbs.edu

Source: A.C. Edmondson, Qual Saf Health Care 2004; 13:ii3-ii9. http://qhc.bmjjournals.com

Loud Wake-up Call: Unlabeled Containers Lead to Patient's Death

As the Thanksgiving holiday began last week, another tragic medication error claimed the life of a 69-year-old Seattle woman, caused in large part by unlabeled basins of solution in the interventional radiology procedure room. During coil placement under cerebral angiography to repair a brain aneurysm, a patient was accidentally injected with an antiseptic skin prep solution, chlorhexidine, instead of contrast media. Both solutions were clear and available on the sterile field in unlabeled basins. The hospital's recent decision to switch antiseptics from a brown povidone-iodine solution to a clear chlorhexidine solution resulted in a latent failure - two look-alike, clear solutions on the sterile field that were previously distinguished by color. This latent failure was revealed when the unlabeled solution basins were mixed up.

Source: http://www.ismp.org, December 2, 2004.

The Truth about Hospital Formularies: We've Come a Long Way or Have We?

What does the term "formulary" mean in a hospital? If you're a pharmacist, do you consider the formulary a continuously changing list of preferred drug products that reflects clinically proven pharmacologic improvements available in the marketplace? Or is it merely an administrative device for identifying the drugs that can be ordered through a group purchasing agreement, or just a subset of the real formulary when you consider the frequency with which physicians prescribe "non-formulary" drugs?

The survey (that appears on page 4 of the PDF version of the newsletter) describes the formulary myths initially identified by Rucker and Schiff in 1990. Survey findings will report in an early 2005 issue of the newsletter.

Source: http://www.ismp.org, November 18, 2004.

FDA and the Pharmaceutical Industry Must be More Responsive for a Safer Healthcare System.

The landmark Institute of Medicine (IOM) report, “To Err is Human: Building a Safer Health System”, was released in November 1999. This year, many healthcare providers, researchers, consumer advocacy groups, and patient safety agencies will be reporting on progress over the past 5 years in making healthcare safer for patients. One significant resource to help evaluate progress in medication safety will be the comparative results from the 2000 and2004 “ISMP Medication Safety Self-Assessment” for hospitals. ISMP reports that the initial review of the findings shows that, collectively as a nation, hospitals have made considerable headway in adopting safe practices known to reduce medication errors.

Source: http://www.ismp.org, November 4, 2004.

Safety Issues

FDA Reviews Data for Single-Use Device Reprocessing

The U.S. Food and Drug Administration has completed its review of supplemental validation data submitted by companies that reprocess single-use devices. The FDA received 44 supplemental validation submissions and, based on the submitted data, found that 11 of the submissions must be withdrawn from the market. Reprocessors may see FDA clearance to market the products in the future by submitting a new pre-market notification (501k) application to the FDA.

United Nations Joins Patient Safety Advocacy Initiative

The United Nations public health agency is launching a new program, World Alliance for Patient Safety, http://t.lt04.net/c.asp?ltk=1790753_16247253, that will set worldwide standards that would reduce the number of preventable new illnesses, injuries and deaths that now cost billions of dollars. The program would work toward eliminating health care infections. It will involve patients to standardize terminology, generate best practice guidelines and promote solutions.

Leapfrog Group Releases Safety and Quality Survey Results

The Leapfrog Group has released the results of its hospital quality and safety survey which encompassed more than 1,000 hospitals. This survey included measures that cover all 30 of the National Quality Forum’s safety practices and collected data on a hospital’s progress toward implementing practices in four categories:

Influenza Virus Vaccine Shortage Update

The Centers for Disease Control and Prevention (CDC) recently announced plans to distribute the remaining 10.3 million doses of Aventis Pasteur influenza vaccine to state health departments, which will then help ensure the doses reach those people at highest risk for complications from influenza. The vaccine will be distributed over several weeks through December and into January.

OSHA Strategic Plan Includes Improving Impact on Occupational Health Outcomes

The Occupational Safety and Health Administration’s Strategic Management Plan includes a goal for the improvement of its impact on occupational health outcomes. Work groups working jointly with the National Institute for Occupational Safety and Health have been formed and are focusing on four areas: emphasizing the importance of industrial hygiene, improving the quality of industrial hygiene services, improving
the industrial hygiene targeting process and improving OSHA’s health outcomes measurement.

CMS Ruling to Allow Handrub Dispensers in Hospital Corridors

A Centers for Medicare and Medicaid Services rule prohibiting the placement of alcohol-based sanitizers in exit corridors is being lifted, according to a letter from
CMS to the Association of Professionals in Infection Control and Epidemiology.
The rule is now under review and due to be published in the Federal Register on December 23, 2004. The letter indicates the effective date of the rule will be
February 23, 2005. However, the current regulation will remain in place until that date.

Source: VHA Safety E-News