September 2007
Dear Colleague:
A major move to improve the safety of medical devices – On September 21, Congress approved a law requiring the Food and Drug Administration (FDA) to put into place a unique medical device identification (UDI) system.
Sincerely,
Gina Pugliese, editor
Vice President, Premier Safety Institute
News
- Congress approves law for FDA to create unique device identification of medical devices - recent survey confirms benefit to patient safety
- Anxiety about future errors, reputation and sleeplessness among the top effects on physicians following a medical error
- Making the business case for preventing hospital-associated infections
- Premier & Wye River Group launch best practices Web site on "Leading healthy communities"
- Color-coded patient ID wristbands – the good news and bad news
- New Jersey hospitals reduce pressure ulcers by 70 percent through collaboration
- Harvard "Patient Safety Imperative" – Course for clinicians in October 2007
Safety tools
- FDA – Free patient safety videos
- Webcast – Best practices to reduce catheter-related blood stream infections
- Online learning module – C. difficile
- NCI – End-of-life care tool
Congress approves law for FDA to create unique device identification of medical devices - recent survey confirms benefit to patient safety
Congress has passed legislation that would require the FDA to create a unique device identification (UDI) system for medical devices. Hospital staff agree that a UDI would assist with locating and tracking medical devices and enhance patient safety, according to a recent survey conducted by Premier's Safety Institute.
Survey Results
A "device recall survey" was sent to Premier's Safety Share subscribers as part of Premier's
broad effort to gather information on the current methods used in healthcare
settings to record and track information on medical devices. More than 80
percent of the more than 1,000 survey respondents stated that a national UDI
system would enhance patient safety. The most common method used to document
information on a patient record regarding an implanted medical device was
reported to be transfer of a product label into the patient's record (60
percent). When recalls occur, nearly all hospitals are conducting manual
searches of records or logs to identify patients who received a recalled device
or product. Premier submitted the survey results with its
formal comments to the
FDA in November 2006.
Experts call for UDI
Supply chain managers and industry experts will be
pleased to learn of the new legislation requiring UDI. Lack of a UDI is
generally agreed to be one of the main reasons for increased supply costs and
inefficiencies in the supply chain. The cover story and several related articles
in the September 2007 issue of Materials Management in Healthcare
addresses the industry challenge to implement UDI and all the synchronization
that is needed to make it happen.
In one article, Joe Pleasant, CIO of Premier Inc., explains, "The absence of a UDI causes patient safety issues. Unlike virtually every other product in commerce, medical supplies and devices cannot currently be identified in a systematic and consistent manner. Without the UDI, it is difficult to track the recipient of a faulty product (e.g., recalls of implantable devices) or to consistently track adverse events related to a specific product."
Congress
passes legislation requiring UDI
Congress has already agreed that UDI is an
important safety issue and passed a bill this past week that will require the
FDA to create a UDI system for medical devices. The
UDI language
was included in the FDA Amendments Act of 2007 (H.R. 3580), which
would reauthorize user fee programs under the FDA and expand FDA's authority to
monitor medical devices and prescription drugs. The Senate passed H.R. 3580 by
unanimous consent and the House approved the bill by a vote of 405-7. The
president is expected to quickly sign the bill due to the expiration of funding
for the programs being reauthorized.
Safety Institute's UDI recall survey
Formal comments to FDA – FDA request for information
Material Management September 2007
The unique device identification (UDI) language
Food and Drug Administration Amendments Act of 2007 (H.R. 3580)
For additional information, go to the Safety Institute's Unique Device Identifier (UDI) resources.
Anxiety about future errors, reputation and sleeplessness among the top effects on physicians following a medical error
A recent study by Waterman and colleagues identified the impact of errors on 3,171 physicians in the United States and Canada responding to a survey. The majority of physicians said they experienced significant emotional distress and job-related stress following near misses and medical errors. These stresses included increased anxiety about future errors, decreased job confidence, increased sleeplessness, and anxiety about harming their professional reputation. Physicians said they were more likely to report these stresses as the severity of error increased.
Nearly all said that their healthcare organization provided inadequate support services to cope with stress after a medical error. Although 80 percent were interested in counseling, many reported barriers to seeking counseling, including a concern about the confidentiality of what was said in counseling if they were sued and that they would be judged negatively by their peers.
Disclosure of errors to patients was also associated with job-related stress. Physicians who were dissatisfied with how their past serious error disclosure was handled were four times more likely to report stress after a serious error. Although only 18 percent of physicians surveyed had received education or training in disclosure of errors, 86 percent expressed interest in such education or training.
Physicians most affected by errors
Multivariate modeling revealed that some physicians reported more job-related
stress following errors than others. Physicians who spent more than 75 percent
of their time in clinical practices – and female physicians in general – were
more likely to report stress after a serious error than other physicians. Other
research has shown that female physicians, especially those in male-dominated
specialties like surgery have less access to supportive role models and report
higher levels of job stress compared to their male counterparts. However, the
study authors noted that it is unknown whether these gender differences reflect
a greater willingness of female physicians to openly report their elevated
stress levels beyond that of male physicians.
The authors recommended that hospitals and other healthcare organizations broaden the array of formal and informal error-related support available to physicians during and after work hours. This might include critical incident stress debriefings, telephone or in-person counseling with therapists or physicians with personal experience with errors. Discussions of how physician leaders coped after their own error experience send a message that seeking support after errors is not a sign of weakness. Physicians should also be better informed that their conversations are protected from discovery in the event of a lawsuit.
Waterman, JC Journal Quality Patient Safety, August 2007 (.doc) (21 KB)
Making the business case for preventing hospital-associated infections
Hospitals may not receive direct reimbursement for their infection prevention and control programs and may lose money beginning in October 2008, when CMS implements its most recent initiative to deny additional reimbursement for reasonable preventable hospital-associated conditions, including catheter-associated urinary tract infections, IV catheter-associated bloodstream infections, and mediastinitis surgical site infections following coronary artery bypass graft surgery. A detailed business case analysis for hospital-associated infections was recently published by the Society for Healthcare Epidemiology of America (SHEA) to assess the financial impact of prevention programs as well as a specific infection control intervention.
Drawing data from 14 representative studies, the authors began by identifying attributable costs (mean cost in U.S. dollars) and excess length of stay (mean number of days) for four major types of hospital-associated infections (HAIs):
- Ventilator-associated pneumonia (VAP): $ 22,875 and 9.6 days;
- Catheter-related bloodstream infections (CR-BSI): $18,432 and 12 days;
- Coronary artery bypass graft-associated surgical site infection: $17,944 and 25.7 days; and
- Catheter-associated urinary tract infection (UTI): $1,257.
Details were provided for nine steps that are necessary to complete a business case analysis. These steps include:
- Describe the problem and develop a hypothesis regarding possible solutions;
- Meet with key administrators;
- Determine the annual cost of the program;
- Determine what costs can be avoided through reduced infections;
- Determine the costs associated with the infection of interest at your hospital;
- Calculate the financial impact of the proposed intervention or program;
- Include financial or health benefits of the proposed intervention or program;
- Make your business case; and
- Prospectively collect cost and outcome data once the program is in effect.
Use of mathematical modeling to assess cost-effectiveness of surveillance for MRSA
The guideline outlines a type of analysis called mathematical modeling that can be used to assess the cost-effectiveness of a specific intervention. An example is provided on the use of a model, in the absence of clinical trials, to assess the cost-effectiveness of active surveillance (culturing) and isolation of patients to control the spread of antimicrobial-resistant organisms in hospitals such as MRSA. The guideline points out that many factors or variables can be individually evaluated, including those related to population (e.g., size of ICU, discharge rate, length of stay), to individual patients (e.g., comorbidities and age), to infectious organisms being evaluated (e.g., duration of colonization and likelihood of infection). These factors can be evaluated with modeling strategies to assess their individual and combined importance in causing the observed outcome. This type of evaluation is called sensitivity analysis and is used in most mathematical and decision models.
The lead author of SHEA's evidence-based guideline, Eli Perencevich, M.D., presented an example of a mathematical modeling of the cost effectiveness of various surveillance strategies (passive and active surveillance for MRSA in a 10 bed ICU) at a recent Premier conference on healthcare associated infections. In his June 19, 2007, presentation: The Business Case for Infection Control, Perencevich outlined the factors or variables that needed to be considered in the analysis, including MRSA prevalence on admission to the unit, size of the unit, number of MRSA cases per year, compliance with obtaining active-surveillance cultures; and effectiveness of isolation. His modeling showed that the cost of a MRSA prevention program using active surveillance cultures with rapid screening in a 10-bed ICU with 40 MRSA cases per year would cost $1,480 per case prevented, for a total program cost of $44,630.
CMS IPPS rule (8/22/07) http://www.cms.hhs.gov/center/hospital.asp
Perencevich et al. Business case ICHE, September 2007. (.doc) (29 KB)
Perencevich presentation slides – available at http://www.premierinc.com/advisorlive/ Go to: June 19
Premier & Wye River Group launch best practices Web site on "Leading healthy communities"
A valuable new Web site is available to help improve the health of underserved populations. The Web site – LeadingHealthyCommunities.com – hosts a repository of best practice case studies from dozens of award-winning, community based health initiatives from around the nation. The site was launched by Premier and the Wye River Group on Healthcare and its affiliate Foundation for American Healthcare Leadership, not-for-profit forums for collaboration and open exchange of ideas to promote constructive healthcare system change. The site also offers a library of information and tools that can help others successfully address issues of access, quality, cost, disparities, immunizations, prenatal care, and others. At a time of increasing problems with access to quality healthcare, this site will help organizations better succeed and meet the need of people in their communities.
The purpose of "Leading Healthy Communities" is to provide community health leaders a single source of practical information supporting the creation, financing and execution of community initiatives aimed at improving the health of the community. The site has two key components: dozens of case studies illustrating "how to be successful" and a comprehensive "action guide" that provides templates, surveys and step-by-step guides to building community support.
Link to your Web site for easy access to these tools: http://www.leadinghealthycommunities.com
Case studies: http://www.leadinghealthycommunities.com/case-studies/
Action guide: http://www.leadinghealthycommunities.com/action-guide/
Color-coded patient ID wristbands – the good news and bad news
The California Hospital Association (CHA) Board is among the latest state boards to approve the use of standardized color-coded patient identification wristbands to improve safety. Although similar color codes are used by other states, there still are variations that may cause confusion. The status of several states follow.
California – Following the path of other hospitals in the southwestern states, the California Hospital Association (CHA) Board of Trustees approved the use of specific color-coded patient identification wristbands such as red bands for "allergies," yellow for "fall risk," and purple for "do not resuscitate" (DNR). These rules apply to all California hospitals that use color-coded wristbands. A survey of California nurse executives supported the development of a statewide standard for using color-coded wristbands. One survey found that 54 percent already use a color-coded system, and 88 percent support standardizing those colors. Seven solid colors and various multi-color bands were being used to represent 29 different conditions in California hospitals. The many different bands in use could lead to confusion and medical errors. (See Table below.)
Other western states – Arizona led the move to standardize wristbands in its hospitals as well as in neighboring states. In addition to California, Colorado, Nevada, New Mexico and Utah began exploring the issue. Through the "Western Region Alliance for Patient Safety" (WRAPS), the Arizona group hopes to eventually spread the standardization to hospitals throughout the country because critical nursing shortages mean some nurses often work in multiple medical facilities, and hospitals often rely on travel nurses. The Arizona Hospital and Healthcare Association campaign is called "Safe and Sound" and all hospitals in the state are urged to use the same colored bands to signify the same patient conditions.
Pennsylvania – The Pennsylvania Patient Safety Reporting System has advocated use of standardized color-coded wristbands with its "Color of Safety" initiative since 2005, when a patient was almost not resuscitated because of a misinterpretation of the band color on the patient's wrist.
Minnesota – The Minnesota Hospital Association (MHA) Patient Safety Committee also has recently made a recommendation that Minnesota adopt a statewide standard code for patient wristband colors. Until more effective means to communicate patient information are established, Minnesota organizations that use colored wristbands to communicate patient information are advised to use the recommended color codes. Three other models reviewed by Minnesota before making their recommendations included the Pennsylvania Safety Authority, the Western Regional Alliance for Patient Safety, and the Ohio Patient Safety Institute.
Ohio Patient Safety Institute – A survey of hospitals in the state found providers are using 19 different colors with 28 different meanings. Although allergy and fall risk are similar to other states, there are a few differences. Implementation was scheduled for September 1. The current code for DNR is white/clear with the DNR logo, and is currently under review with no recommendation at the time of implementation.
The Missouri Center for Patient Safety also has implemented voluntary standards for Missouri's hospitals.
Following is a summary of various types of wristbands and how they are identified by different states:
| St. / Region | Allergy | Fall | DNR | Latex | Rest. extrem. | Blood Product | Pateint ID |
| AZ, CO, NV, NM, UT (WRAPS) |
Red | Yellow | Purple | - | - | - | - |
| CA | Red | Yellow | Purple | - | - | - | - |
| MN | Red | Yellow | Purple | Green | Pink | - | - |
| MO | Red | Yellow | Purple | - | - | - | - |
| OH | Red | Yellow | (Pending) | - | - | Green | White-clear |
| PA | Red | Yellow | Blue | Green | Pink | - | - |
Arizona Patient Safety Initiative" Safe & Sound" Implementation Toolkit information (Note the AZ Toolkit is 19 MB) http://www.azhha.org/public/quality/. Go to #3, Wristband Toolkit.
Ohio Patient Safety Institute (.pdf) (186 KB)
Colorado’s toolkit APPEND 3_Colorado toolkit or go to http://www.cfmc.org/files/hospital/Wristband_CO_toolkit.pdf
See the Missouri Tool kit (3MB) (Append 5_Missouri tool lit) or go to http://www.mocps.org/initiatives/Banding_ToolKit.pdf
New Jersey hospitals reduce pressure ulcers by 70 percent through collaboration
The New Jersey Hospital Association’s (NJHA) Pressure Ulcer Collaborative, a special project designed to eliminate pressure ulcers, reports that a group of 150 New Jersey hospitals, nursing homes, and home care agencies eliminated nearly three-fourths of new pressure ulcers in less than two years. The coalition dramatically exceeded an original goal of 25 percent, achieving a 70 percent reduction through collaboration such as sharing best practices and other preventive techniques.
Pressure ulcers, or bed sores, usually located around bony areas of a patient’s body, affect more than 1 million patients and residents in nursing homes and hospitals each year. The associated costs for treatment can exceed $1.3 billion. Tracking pressure ulcers from September 2005 through May 2007, 48 of the 150 members of the NJHA Collaborative reported achieving results of no new pressure ulcers for a period of three months or more; the prevalence of existing pressure ulcers as patients moved from one care setting to another was also reduced by 30 percent.
Preventive interventions Preventive steps began with a new patient receiving a skin evaluation within eight hours of admission and an evaluation of the risk of skin breakdown using the internationally respected Braden scale. Position changes were performed every two hours, along with the use of heel cushions, padding, and use of special mattresses that alternately inflate and deflate. The key to the Collaborative's success was communication – simple sharing of knowledge and improved efforts at coordination of healthcare services between hospitals and nursing homes. The results show that the collaborative was able to achieve measurable, significant improvement in the quality of care across all care settings.
NJHA press release (.doc) (24 KB)
New York Times article,"Group Reduces Number of Patients With Bedsores." http://www.nytimes.com. Search August 5, 2007.
Minnesota experience: Safety
Share March 2007 (.pdf)
(975 KB)
Pressure Ulcer scale
National Pressure Ulcer Advisory
(.pdf) (98 KB)
Harvard "Patient Safety Imperative" – Course for clinicians in October 2007
The Patient Safety Imperative is being held at the Hilton Boston Back Bay, Boston, October 22-23, 2007. Designed for practicing physicians, medical educators, practice directors, nurses, pharmacists, risk managers, quality improvement professionals, health administrators and health services researchers, the course focuses on emerging trends and best practices.
The course opens with an introduction to the problem of medical error and its emergence as a major public health problem. Large group lectures address the nature of error in healthcare, drawing heavily from human factors engineering and systems theory. Tools for identifying, measuring, and analyzing adverse events, and for applying continuous quality improvement techniques to error prevention, will be provided. The problem of impaired providers, and emerging concepts of physician responsibility and error disclosure will be addressed, along with an examination of policy, patient, and risk management perspectives on error. It will offer special sessions on medical education, simulation and teamwork, and patient safety leadership.
Supported by the Premier Safety Institute, the course is sponsored by the Dana-Farber Cancer Institute Center for Patient Safety, Brigham and Women's Hospital’s Department of Medicine and Center of Excellence for Patient Safety Research and Practice, and Beth Israel Deaconess Medical Center’s Department of Medicine. Fee for the two-day course is $695 ($395 for residents and fellows).
Download additional course information, including a complete faculty listing, agenda, CEUs, and online registration, are available at the conference Web site at: http://cme.med.harvard.edu/cmeups/pdf/00271307.pdf
Safety tools
FDA – Free patient safety videos
The latest medication safety-related videos, developed by the FDA in cooperation with ISMP, are now available free for viewing or downloading on the ISMP Web site (http://www.ismp.org/Tools/fdavideos.asp). See below for the latest 2007 offerings.
- September 2007: Caution on No-Name Drug Patches and Preventing Patient Deaths from Fentanyl Patches
- July 2007: Avoiding Dangerous Mix-ups between Insulin and Heparin
- June 2007: Preventing Drug Mix-Ups: Bumetanide and Norepinephrine
- March 2007: Possible Dose-Counter Errors with the Asmanex Twisthaler
Webcast – Best practices to reduce catheter-related blood stream infections
Catheter-related blood stream infections (BSI) are a significant source of
morbidity and mortality associated with a variety of devices used to access the
vascular system. Meticulous aseptic technique is both required and effective to
prevent BSI. Faculty share their observations, best practices, and outcome data
as they discuss this important topic. This free webcast is a replay from the
original August 17, 2007, webcast provided by Cardinal Health's Center for
Safety and Clinical Excellence and will remain available for one full year.
Continuing education credit is also provided. Go to:
http://www.cardinal.com/clinicalcenter/
materials/webcasts/index.asp
Online learning module – C. difficile
A free interactive video module that will help identify and treat C. difficile is available from the British Medical Journal (BMJ) and the Department of Health. Titled "How you can reduce C. difficile infections," the video demonstrates how a major UK hospital successfully managed an outbreak and introduced measures that can be applied to prevent infections. The module discusses how to diagnose and treat patients with C. diffcile infections, the importance of hand hygiene in preventing infection, the cautious use of prescribing antibiotics, and understanding the patient experience. To begin the module, go to http://bmjlearning.com/cdifficile.
NCI – End-of-life care tool
The National Cancer Institute (NCI) has published a free palliative-care training program for health professionals caring for cancer patients. The "Education in Palliative and End-of-Life Care for Oncology" CD-ROM and DVD teaches palliative care competencies and interventions for cancer patients. The curriculum is designed to provide the practicing clinician with information and strategies necessary to provide palliative interventions to his or her patients and to provide educational tools and materials to use in teaching the core competencies of palliative care to trainees. This curriculum is eligible for continuing education credit for physicians and nurses. The CD can be ordered or a brochure downloaded online. For more information, go to the NCI Web site at http://www.nci.nih.gov/aboutnci/epeco.
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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
- Derek Kleckner, CUA, 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.
Safety Share © 2007 Premier, Inc.
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