Premier Safety Share
In this edition
Premier Safety Web site
September 11, 2002
Dear Colleague:
Our newsletter is arriving on the first anniversary of September 11th . This is a day of remembrance of our losses, a reflection on peace and healing, and a tribute to our nation's strength.
We are dedicating our Disaster Readiness Web site module to our public health, hospital, and community safety partners. We have all come to recognize that they stand ready to serve.
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Sincerely, Gina Pugliese, Editor |
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News
- 9/11 prompts additional resources and communications
- Poor labeling contributes to acetaminophen overdoses
- FDA moves to protect patients from contaminated transplant tissue
- CDC provides West Nile virus resources for clinicians and families
- FDA issues guidance on cellular phone use
- JCAHO cites link between nursing shortage, negative outcomes
- CDC guidelines address antimicrobial catheters and bloodstream infections
- New look for OSHA online resources
- DOT’s infectious substance transport rule includes new training requirements
Short takes
- AHRQ provides resources to reduce pediatric medicine errors
- New study warns of air mattress dangers
- FDA initiates Web-based safety notification program
- Surgery delays linked to shortage of anesthesiologists
9/11 prompts additional resources and communications
As the first anniversary of Sept. 11, 2001, approaches, government and professional agencies are providing resources for hospitals to use in assessing their plans for dealing with terrorism.
The American Hospital Association (AHA) has issued an advisory urging hospitals tell their communities about terrorism preparedness measures that have been put in place since the attacks. The advisory offers a checklist of suggested activities for hospitals, including developing a brief report on how the facility has enhanced the community's readiness to deal with biological, chemical or nuclear/radiologic terrorism; sharing information with staffers as they prepare to talk with the general public and lawmakers; and educating local officials about progress the hospital and other frontline response organizations have made in meeting the new threats.
The Agency for Healthcare Research and Quality (AHRQ) has posted a survey on its Web site that hospitals can download and use as a checklist for assessing their capacity to treat victims of bioterrorist attacks, or for evaluating existing emergency plans. The checklist includes questions from AHRQ's Bioterrorism Emergency Planning and Preparedness Questionnaire for Healthcare Facilities, covering such subjects as biological weapons training for hospital personnel, procedures to permit rapid recognition of credentialed staff from other facilities, on-call nursing policies, and designated areas of emergency overflow for patients. The survey also addresses such topics as the hospital’s supply of selected antibiotics and the diagnostic capabilities of the in-hospital laboratory.
In a recent telebriefing, Centers for Disease Control and Prevention (CDC) Director Julie Gerberding highlighted a $1 billion effort by the Department of Health and Human Services to bolster preparedness. Through the CDC, these funds will be made available to state and local health departments for efforts focusing on critical components of preparedness. "Many states have achieved the benchmark capacities or are well on their way to achieving benchmark capacities in this regard," Gerberding said. The full transcript of the telebriefing may be downloaded below.
- For a complete version of the AHA advisory, go to http://www.hospitalconnect.com; go to Portals, then AHA.
- Download the AHRQ checklist (135 KB)
- Download a transcript of the CDC telebriefing (75 KB)
Poor labeling contributes to acetaminophen overdoses
According to the American Academy of Pediatrics, 27,000 accidental overdoses of acetaminophen – resulting in severe morbidity or death – are administered to children each year. Because the infant formulation of acetaminophen is approximately three times more potent than the children's formulation, accidental overdoses can occur in several ways:
- Parents may confuse the two products and give a child the prescribed dose (mL or drops versus tablet) of the more concentrated infant drops.
- Parents may purchase the wrong formulation, or have both formulations on hand if there are children of different ages in the household. If parents use infant drops for an older child, and the physician assumes that the children's formulation will be used, the volumetric dose the physician prescribes will be incorrect.
- The risk of confusion is exacerbated by the labeling of the drug products, both of which simply indicate the typical dose (160 mg per 5 mL, and 160 mg per 2 droppersful) without making any distinction between the two versions.
- The term "droppersful" also is misleading and may be construed to mean a "full dropper," rather than the one-half to three-quarters indicated by the fill line on the dropper (1.6mL).
- The white markings (indicating 0.8 and 1.6 mL) are not readily visible on the translucent plastic dropper.
- Even if parents use the correct acetaminophen strength, they may measure the dose incorrectly, especially if they use a household teaspoon.
- According to some reports, the measuring cup supplied with Children's Tylenol Liquid is inexact: the "1 teaspoon" mark measures nearly 6 mL, well over the correct amount.
- Extra doses present another possibility of overdose. Children may sneak an extra sip of the pleasant-tasting medicine, or one parent may not realize that the other parent or caregiver has already administered a dose.
- Children also may receive more than one drug product containing acetaminophen, especially if the box has been discarded and the bottle does not clearly list the active ingredients and strength (as with Infants' Tylenol Cold Concentrated Drops).
To combat the health risk to children and infants, the Institute for Safe Medication Practices (ISMP) and the Pediatric Pharmacy Advocacy Group have developed the first set of guidelines for reducing pediatric medication errors. The guidelines, endorsed by the Society of Pediatric Nurses, are intended for use by children's hospitals, general acute care hospitals that admit pediatric patients, and ambulatory pediatric clinics. Under the guidelines, healthcare practitioners should:
- Be alert to the potential for acetaminophen toxicity and include it in the differential diagnosis in many childhood illnesses.
- Give parents written information on acetaminophen before they leave the hospital with their newborn and during well-baby checkups.
- Educate parents about the different formulations and strengths, and recommend that they avoid using leftover infant formulation as the child gets older.
- Remind parents to keep the outer cartons of products; teach them to read the labels to avoid dosing errors and the accidental administration of multiple products containing acetaminophen.
- Help parents recognize the seriousness of a dosing error and the need to call poison control for advice if they think this has occurred.
- Ensure that parents are familiar with the symptoms of acetaminophen toxicity (nausea, vomiting), since many of the symptoms may prompt additional doses of the drug.
On September 19, 2002, a Food and Drug Administration (FDA) advisory committee will review acetaminophen use. Where warranted, the committee will suggest additional strategies that may help reduce the risk of overdoses.
- Review the complete ISMP alert at http://www.ISMP.org
FDA moves to protect patients from contaminated transplant tissue
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recently launched an investigation into Georgia-based CryoLife, Inc. after a patient died of an infection upon receiving cadaver tissue containing bacterial contaminants.
On August 14, 2002, the FDA ordered a recall of all CryoLife’s distributed human tissue processed since October 3, 2001. Under the order, the firm must also withhold from the market or destroy all tissue processed after October 3. The FDA has determined that CryoLife cannot ensure that the human tissue it processes for transplantation is free from fungal and bacterial contaminants.
Upon conclusion of the investigation in April 2002, the FDA issued a warning letter to CryoLife explaining that investigators documented significant deviations from the Quality System Regulation (QSR). Among other things, the FDA determined that the firm had neither adequately investigated its validation of processing and testing methods, nor implemented recommendations from the CDC or any other procedures to ensure that tissue processed by the firm is not contaminated. CryoLife’s initial response to the FDA was deemed inadequate, as the company failed to take adequate corrective measures to address possible infectious disease contamination of tissue in inventory and distribution. As a result, the FDA issued its August 14 order.
The FDA's Center for Devices and Radiological Health (CDRH) is currently evaluating whether CryoLife's heart valves may present similar risks, and will take further regulatory action if appropriate.
On August 21, the FDA published the complete Public Health Web Notification: Human tissue processed by CryoLife, Inc. that reviews the background on all allograft tissue and provides recommendations for monitoring and reporting any adverse events.
The recall is part of the FDA’s ongoing effort to monitor the safety of tissue used for transplantation. The FDA also makes site visits to tissue processing companies. In a related action, the FDA issued a warning to AlloSource, Inc., of Denver about its failure to adhere to regulations for tissue processing.
CDC provides West Nile virus resources for clinicians and families
West Nile virus (WNV) has the full attention of the public. As of September 9, 985 confirmed or probable cases (including 43 deaths) of WNV among humans have been reported to the Centers for Disease Control (CDC) or compiled by state and local health officials during 2002. To provide families and clinicians with information and recommendations, the CDC’s Division of Vector-Borne Infectious Diseases has developed a Web page.
The WNV Web page includes information about the virus, the disease and its spread, prevention, cases, reporting dead birds, and contacting state and local agencies. The site also includes links to state and local government sites. These include a link to a brochure produced by the Michigan Department of Agriculture which includes useful basic information for families.
Links on the WNV Web page provide press updates on the ongoing investigation of potential virus transmission by blood transfusion and organ donation. CDC has confirmed that current evidence indicates WNV was transmitted from an organ donor to several recipients. The organ donor may have acquired infection through a mosquito bite or from blood transfusions received before organ recovery. CDC states that data are insufficient to indicate any changes to existing organ or blood donor screening and testing practices and continues to closely monitor blood safety with the Food and Drug Administration (FDA).
The WNV Web page provides prevention information focusing on various ways of avoiding mosquito bites, including the safe use of insect repellent. Also included are links to local mosquito control programs as well as frequently asked questions (FAQs).
Case count information includes locations and numbers in an easy-to-read table format. This information is updated Monday through Friday.
CDC has provided links to useful materials for clinicians and laboratorians, such as educational PowerPoint presentations on WNV. CDC also developed a fact sheet for distribution to healthcare providers. West Nile Virus Infection: Information for Clinicians includes information on diagnosis and reporting, laboratory findings, and treatment.
- Download Fact Sheet: Information for Clinicians (95 KB)
- Download WNV brochure at http://www.michigan.gov/documents/WESTNILE_22805_7.pdf
- For more information from CDC on the West Nile virus, go to: http://www.cdc.gov/ncidod/dvbid/westnile/index.htm
- For information from the FDA on blood safety go to: http://www.fda.gov/cber/safety/westnile.htm
FDA issues guidance on cellular phone use
Healthcare providers have expressed confusion over cell phone use in their healthcare facilities. Because an understanding of the basics is critical to emergency preparedness planning, the U.S. Food and Drug Administration (FDA) has compiled a Web page with facts, guidelines, and frequently asked questions (FAQs) on current issues and research.
The Web page provides an in-depth explanation of wireless communications, including the roles of the Federal Communications Commission (FCC) and the FDA, both of which regulate wireless telephones. The FCC ensures that all wireless phones sold in the United States comply with safety guidelines limiting radio frequency (RF) energy, while the FDA monitors the health effects of wireless telephones. Each agency has the authority to take action if a wireless phone produces hazardous levels of RF energy. This issue is particularly relevant to healthcare due to the potential for interference with medical equipment.
JCAHO cites link between nursing shortage, negative outcomes
The growing shortage of nurses in America's hospitals is endangering patients’ lives and requires immediate attention, according to an urgent call for action released by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) – which maintains that failure to address the problem aggressively is likely to result in more deaths, more complications, longer hospital stays, and other undesirable outcomes. A special JCAHO Expert Roundtable has proposed solutions that focus on transforming the nursing workplace, creating a clinical foundation for nurses’ educational preparation and advancement, and providing financial incentives for healthcare organizations to invest in high quality nursing care.
More than 126,000 nursing positions remain unfilled today, and that number is expected to skyrocket by 2010, just as 78 million aging "baby boomers" begin placing unprecedented demands on America's healthcare system. The nurse staffing problem is a major factor in emergency department overcrowding, cancellation of elective surgeries, and discontinuation of clinical services; it also limits the ability of health systems to respond to an incident involving mass casualties. Ninety percent of nursing homes report having an insufficient number of nurses to provide even the most basic of care, and some home health agencies are being forced to refuse new admissions.
The current nursing shortage can be attributed to several interrelated factors, among them job dissatisfaction, an aging workforce, cost-cutting, reductions in hospital resources to support nursing care, lack of adequate educational preparation, overwork and stress resulting from an increasing patient care workload, and extra shifts. In a study conducted by Vanderbilt University in 2001, 93 percent of Americans said the nursing shortage threatens quality of care.
To combat these problems, the JCAHO Expert Roundtable identified the following strategies:
- Transform the workplace: Give nurses the independence and support they need to do their work well, thereby creating a culture of professional satisfaction and encouraging retention. Set staffing levels that take into account the complexities of patient needs and nurses' skills and competencies, and adopt zero-tolerance policies for abusive behaviors by physicians and other healthcare practitioners.
- Bolster nursing education: Ensure that new graduates are better prepared to care for fragile patients. Reinvigorate nursing schools by funding new faculty positions. Provide incentives for nurses to seek advanced degrees. Standardize post-graduate nursing residency programs. Increase federal funding for nursing education to encourage greater interest in the profession.
- Provide funds: Make additional federal funds available to invest in nursing services. Make the continued receipt of these funds conditional upon the achievement of evidenced-based, nursing-sensitive goals, including patient outcomes.
The complete white paper may be downloaded below or from the JCAHO Web site.
- Download executive summary of white paper (29 KB)
- Download the complete JCAHO staffing white paper (273 KB)
- More information is available at http://www.jcaho.org.
CDC guidelines address antimicrobial catheters and bloodstream infections
The Centers for Disease Control and Prevention (CDC) has released revised guidelines for preventing catheter-related infections. The Guidelines for the Prevention of Intravascular Catheter-Related Infections, published in the August 9, 2002, Morbidity and Mortality Weekly Report, focus on:
- Educating and training healthcare workers.
- Using maximum sterile barrier precautions during central venous catheter insertion.
- Using a 2% chlorhexidine preparation for skin antisepsis.
- Avoiding the routine replacement of central venous catheters.
- Using antiseptic/antibiotic-impregnated short-term central venous catheters if the rate of infection remains high despite the use of other precautions.
The guidelines – an update of the 1996 version – also identify performance indicators healthcare facilities can use to monitor their success in implementing the recommendations. Of special note is Appendix B, which includes a chart of recommended frequencies for replacing catheters, dressings, administration sets, and fluids. Due to a typesetting error in the original publication, a corrected version has been published and may be downloaded below.
- Download the complete guideline (333 KB)
- Download Appendix B table (69 KB)
New look for OSHA online resources
The newly redesigned Web site of the U.S. Occupational Safety and Health Administration (OSHA) includes additional interactive tools. A continuing feature is OSHA's electronic Hospital Tour, which provides information on hazards, controls, standards, and safe employee practices.
OSHA has also included a form for submitting questions to the agency and seeking interpretations of standards and regulations. To submit a question:
- Go to the OSHA home page (www.osha.gov) and scroll to the bottom.
- Click on "Contact us."
- Scroll down to "E-mail correspondence" and click on "E-mail form."
- Complete the form provided.
OSHA asks that correspondents provide enough information about the issue to ensure an appropriate answer. Responses to the electronic mail queries are for informational purposes only, and do not constitute an official communication of the U.S. Department of Labor or OSHA. For an official response, the inquiry should be submitted in writing.
- For OSHA’s electronic Hospital Tour, go to:
http://www.osha.gov/SLTC/hospital_etool/mainpage.html - To correspond with OSHA, go to: http://www.osha.gov/html/Feed_Back.html
DOT's infectious substance transport rule includes new training requirements
On August 14, the U.S. Department of Transportation (DOT) issued revised requirements for transporting infectious substances (Federal Register, Vol. 67, No. 157, pp. 53118-53144). Infectious substances include etiologic agents, regulated medical wastes, diagnostic specimens, and certain biological products. These revisions have been made to conform to World Health Organization criteria and to be consistent with the United Nations Recommendations on the Transport of Dangerous Goods. The effective compliance date for this final rule is February 14, 2003.
"These rules have been proposed for over a year and a half now and are no surprise to the medical waste industry," says Nelson "Sig" Slavik, Ph.D., of Environmental Health Management Systems, Inc., Niles, MI. Slavik testified before DOT on behalf of the American Hospital Association in 1993 and 1995 during the initial development of the rules. The medical waste industry and applicable federal agencies – including the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and the Environmental Protection Agency – have worked closely with the DOT to ensure workable regulations.
Slavik notes, however, that what may come as a surprise is the responsibility the medical facility has under DOT regulations. Of critical concern is the training mandated for healthcare staff involved in the labeling, containment, and manifesting of shipments of infectious substances including regulated medical wastes and diagnostics specimens. Personnel in most healthcare facilities are unaware of DOT training requirements for off-site medical waste shipments, and now these requirements extend to diagnostic specimens. The rules also apply to medical facilities actively involved in research, shipping cultures and stocks of etiologic agents or genetically modified organisms.
Employee training has been an ongoing DOT requirement for transporters of any hazardous materials, including infectious substances. These training requirements now extend beyond the transporter to the facility offering the materials for shipment. The extent of the training depends on the activities in which the medical facility engages when preparing the materials for transport. Specific rules for training are found in 49 Federal Code of Regulations Part 172.704. The healthcare facility should work closely with its transporter to ensure that both the transporter and the hospital comply with training requirements and other DOT requirements for packaging, labeling, manifesting, and emergency response.
The final rule also includes new requirements for shipping diagnostic specimens. Shipping requirements are minimal for those diagnostic specimens containing Risk Group 2 or Risk Group 3 materials (as defined in the final rule). All diagnostic specimens in these categories must be contained in packaging meeting minimum performance criteria and must be marked "Diagnostic Specimens." Diagnostic specimens in Risk Group 1 are not regulated. Any specimen containing Risk Group 4 materials, however, is under the full restrictions of Division 6.2, "Infectious Substances."
Healthcare facilities must familiarize staff with the requirements set forth in the final rule. Ensure that your transporter knows the rules and can provide you with the training required for your employees as well as the packing and labeling materials required for your shipment.
- Download the final rule (248 KB).
Short takes
- AHRQ provides resources to reduce pediatric medicine errors
- New study warns of air mattress dangers
- FDA initiates Web-based safety notification program
- Surgery delays linked to shortage of anesthesiologists
AHRQ provides resources to reduce pediatric medicine errors
The Agency for Healthcare Research and Quality (AHRQ) has sponsored production of a video and related materials from the July 17, 2002, Child Health Speaker Series Web conference. The materials outline methods for reducing errors in pediatric medicine. The Web conference and handouts on child health are available at http://66.77.20.158/ahrq/childhealthwebconf.
New study warns of air mattress dangers
A recently released study cautions doctors that air mattresses used in hospitals, nursing homes, and home care can have deadly consequences for some patients. A patient’s head can become trapped between the rails of the bed and the mattress, leading to asphyxiation and death. After reviewing data from the U.S. Food and Drug Administration's (FDA’s) online database of adverse medical events from 1994 to 2001, Dr. Steven H. Miles of the University of Minnesota in Minneapolis found 35 deaths linked to air mattresses. Dr. Miles found that these fatalities were similar to those occurring when a patient becomes trapped between the bedrails and an ordinary mattress. However, air mattresses pose special challenges: an air mattress can become compressed, forming a gap next to a bedrail, and that gap will close when the mattress reinflates.
- Download the file to review the full article abstract (20 KB)
- The complete study is available for a fee at www.blackwell-synergy.com/member/institutions/issuelist.asp?journal=jgs
FDA initiates Web-based safety notification program
The Food and Drug Administration’s Center for Radiological Health (CDRH) has announced a new Web-based notification program intended to augment its existing safety notification program. The Web notification will disseminate device-related safety information useful to healthcare providers but inappropriate for the FDA’s existing notifications. Web notifications may be used in cases where the available information is limited or subject to change, or when the CDRH may not be able to make specific recommendations but seeks to provide the information to the healthcare community in a timely fashion. Web notifications will be updated as additional information becomes available, so healthcare providers are encouraged to check the site frequently. The Web notification page includes safety alerts, public health advisories, and notices from CDRH. Go to http://www.fda.gov/cdrh/safety.html#web.
Surgery delays linked to shortage of anesthesiologists
A new survey conducted by the American Society of Anesthesiologists indicates that larger hospitals reporting a shortage of anesthesiologists are also delaying elective surgery and limiting access to operating rooms. Forty-seven percent of senior administrators from hospitals with more than 100 beds said they did not have enough anesthesiologists on staff. Three-quarters of the administrators who cited a shortage also reported an increase in patients’ surgery wait time.
- Downloaded the report (22 KB)
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.