IMPORTANCIA DEL ALERTA DEL EVENTO CENTINELA

Sentinel Event Alert © 2008 The Joint Commission, All Rights Reserved

Issue 42, December 11, 2008

Safely implementing health information and converging technologies

As health information technology (HIT) and “converging technologies”—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations,1,2 users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission. These unintended adverse events typically stem from human-machine interfaces or organization/system design.3 The overall safety and effectiveness of technology in health care ultimately depend on its human users, ideally working in close concert with properly designed and installed electronic systems. Any form of technology may adversely affect the quality and safety of care if it is designed or implemented improperly or is misinterpreted. Not only must the technology or device be designed to be safe, it must also be operated safely within a safe workflow process.

Previous Sentinel Event Alerts have addressed specific technology-related safety issues: infusion pumps (issue 15), ventilators (issue 25), patient-controlled analgesia (issue 33), tubing misconnections (issue 36) and MRI (magnetic resonance imaging) (issue 38). In addition, technology-related adverse events in health care can involve, but are not limited to, computerized provider order entry (CPOE), automated dispensing cabinets (ADCs), electronic medical records (EMRs), clinical decision support (CDS), bar coding or RFID (radio frequency identification), virus threats to information security, CT (computed axial tomography ) scanning technology, and the loss of patient data. According to a 2007 study conducted by the American Society of Health-System Pharmacists, approximately 83 percent of hospitals in the U.S. have ADCs, 44 percent have smart pumps, 43 percent have EMRs, 24 percent have bar code medication administration, 18 percent have CPOE, 13 percent have intelligent medication carousel systems for pharmacy inventory picking, and 10 percent have robots for unit-dose packaging and dispensing.1 There is extensive literature available about the uses and potential risks of these technologies. This Alert focuses on how to safely implement HIT and converging health technologies.

There is a dearth of data on the incidence of adverse events directly caused by HIT overall. The United States Pharmacopeia MEDMARX database includes 176,409 medication error records for 2006, of which 1.25 percent resulted in harm. Of those medication error records, 43,372, or approximately 25 percent, involved some aspect of computer technology as at least one cause of the error. Most of the harmful technology-related errors involved mislabeled barcodes on medications (5 percent), information management systems (2 percent), and unclear or confusing computer screen displays (1.5 percent). The remaining harmful errors were related to dispensing devices, computer software, failure to scan barcodes, computer entry (other than CPOE), CPOE, and overrides of barcode warnings. (See the sidebar for a breakdown of these data.) In addition, a 2007 survey4 conducted by the Institute for Safe Medication Practices (ISMP) showed that safety improvements with ADCs have not kept up with the growing popularity of the technology. According to the 800 respondents to the survey, 94 percent are using ADCs and of those, 56 percent are using the technology as the primary means of drug distribution.4,5,6 ISMP recently released the first set of interdisciplinary guidelines to promote safety practices with ADCs.7

USP MEDMARX Computer Technology-Related Harmful Errors (2006)

Cause Number %
Barcode, medication mislabeled
20 5
Information management system
1,176 2
Computer screen display unclear/ confusing
137 1.5
Dispensing device involved
3,181 1.3
Barcode, failure to scan
114 <1
Computer entry (general, other than CPOE)
24,715 <1
CPOE
10,752 <1
Barcode, override warning
41 0
Total 43,372*
* From a total of 176,409 medication error records.

Contributing factors
Inadequate technology planning can result in poor product selection, a solution that does not adapt well to the local clinical environment, or insufficient testing or training. Inadequacies include failing to include front-line clinicians in the planning process, to consider best practices, to consider the costs and resources needed for ongoing maintenance, or to consult product safety reviews or alerts or the previous experience of others. Implementing new clinical information systems can expose latent problems or flawed processes with existing manual systems; these problems should be identified and resolved before implementing the new system. An over-reliance on vendor advice, without the oversight of an objective third party (whether internal or external), also can lead to problems. “There’s often an expectation that technology will reduce the need for resources, but that’s not always true,” says Bona Benjamin, BS Pharm, director of Medication-Use Quality Improvement, American Society of Health-System Pharmacists. Instead, technologies often shift staffing allocations, so there is not typically a decrease in staff.

Technology-related adverse events also happen when health care providers and leaders do not carefully consider the impact technology can have on care processes, workflow and safety. “You have to understand what the worker is going through – whether that worker is a nurse, a doctor, a pharmacist or whoever is using the technology. The science of the interplay between technology and humans or ‘human factors’ is important and often gets short shrift,” says Ronald A. Paulus, M.D., chief technology and innovation officer, Geisinger Health System.

If not carefully planned and integrated into workflow processes, new technology systems can create new work, complicate workflow, or slow the speed at which clinicians carry out clinical documentation and ordering processes. Learning to use new technologies takes time and attention, sometimes placing strain on demanding schedules. The resulting change to clinical practices and workflows can trigger uncertainty, resentment or other emotions that can affect the worker’s ability to carry out complex physical and cognitive tasks.8 For example, through the use of clinical, role-based authorizations, CPOE systems also exert control over who may do what and when. While these constraints may lead to much needed role standardizations that reduce unnecessary clinical practice overlaps, they may also redistribute work in unexpected ways, causing confusion or frustration. Physicians may resent the need to enter orders into a computer. Nurses may insist that the physician enter orders into the CPOE system before an order will be carried out, or nurses may take over the task on behalf of the physician, increasing the potential for communication-related errors. Physicians have reported a sense of loss of professional autonomy when CPOE systems prevent them from ordering the types of tests or medications they prefer, or force them to comply with clinical guidelines they may not embrace, or limit their narrative flexibility through structured rather than free-text clinical documentation.8 Furthermore, clinicians may suffer “alert fatigue” from poorly implemented CPOE systems that generate excessive numbers of drug safety alerts. This may cause clinicians to ignore even important alerts and to override them, potentially impairing patient safety.9

Patient safety is also impaired by the failure to quickly fix technology when it becomes counterproductive,10,11 especially because unsolved problems engender dangerous workarounds.12 Additionally, safety is compromised when health care information systems are not integrated or updated consistently.10, 11,13,14,15,16,17,18 Systems not properly integrated are prone to data fragmentation because new data must be entered into more than one system. For example, when the CPOE system is not interfaced with the pharmacy system, each order must be printed manually and then electronically transcribed into the pharmacy system. Multiple networks can result in poor interoperability and increased costs.2 If data are not updated in the various systems, records become outdated, incomplete or inconsistent.

Existing Joint Commission requirements
The Information Management chapter covers electronic information. With respect to patient safety and technology, organizations should pay particular attention to the following standards:

IM.1.10 (IM.01.01.01*) addresses planning the management of information.
IM.2.20 (IM.02.01.03*) requires the safeguarding of data and information against loss, destruction and tampering.
IM.2.30 (IM.01.01.03*) requires a disaster recovery plan for information systems and the periodic testing of the plan to ensure its effectiveness.
Leadership standards LD.4.20 (LD.04.04.03*) and LD.4.40 (LD.04.04.05*) address designing new processes and establishing a safety program. In addition, since technology is prevalent in health care – from patient admission to the surgical suite to the ordering and administration of medication and the use of equipment and medical devices – any Joint Commission standard could potentially be tied to technology. Users should consider the use of any technology in relation to the standards and be aware of potential dangers to patients, as in any clinical situation.

Joint Commission suggested actions
Below are suggested actions to help prevent patient harm related to the implementation and use of HIT and converging technologies.

Examine workflow processes and procedures for risks and inefficiencies and resolve these issues prior to any technology implementation. Involving representatives of all disciplines—whether they be clinical, clerical or technical—will help in the examination and resolution of these issues.
Actively involve clinicians and staff who will ultimately use or be affected by the technology, along with IT staff with strong clinical experience, in the planning, selection, design, reassessment and ongoing quality improvement of technology solutions, including the system selection process. Involve a pharmacist in the planning and implementation of any technology that involves medication.
Assess your organization’s technology needs beforehand (e.g., supporting infrastructure; communication of admissions, discharges, transfers, etc.). Investigate how best to meet those needs by requiring IT staff to interact with users outside their own facility to learn about real world capabilities of potential systems, including those of various vendors; conduct field trips; and look at integrated systems (to minimize reliance on interfaces between various vendor systems).
During the introduction of new technology, continuously monitor for problems and address any issues as quickly as possible, particularly problems obscured by workarounds or incomplete error reporting. During the early post-live phase, consider implementing an emergent issues desk staffed with project experts and champions to help rapidly resolve critical problems. Use interdisciplinary brainstorming methods for improving system quality and giving feedback to vendors.
Establish a training program for all types of clinicians and operations staff who will be using the technology and provide frequent refresher courses.
Training should be appropriately designed for the local staff. Focus training on how the technology will benefit patients and staff, i.e. less inefficiency, fewer delays and less repeated work.12 Do not allow long delays between orientation and system implementation.
Develop and communicate policies delineating staff authorized and responsible for technology implementation, use, oversight, and safety review.
Prior to taking a technology live, ensure that all standardized order sets and guidelines are developed, tested on paper, and approved by the Pharmacy and Therapeutics Committee (or institutional equivalent).
Develop a graduated system of safety alerts in the new technology that helps clinicians determine urgency and relevancy. Carefully review skipped or rejected alerts as important insight into clinical practice. Decide which alerts need to be hard stops when using the technology and provide appropriate supporting documentation.
Develop a system that mitigates potential harmful CPOE drug orders by requiring departmental or pharmacy review and sign off on orders that are created outside the usual parameters. Use the Pharmacy and Therapeutics Committee (or institutional equivalent) for oversight and approval of all electronic order sets and clinical decision support alerts. Assure proper nomenclature and printed label design, eliminate dangerous abbreviations and dose designations, and ensure MAR acceptance by nurses.
To improve safety, provide an environment that protects staff involved in data entry from undue distractions when using the technology.
After implementation, continually reassess and enhance safety effectiveness and error-detection capability, including the use of error tracking tools and the evaluation of near-miss events.19 Maximize the potential of the technology in order to maximize the safety benefits.
After implementation, continually monitor and report errors and near misses or close calls caused by technology through manual or automated surveillance techniques.19,20 Pursue system errors and multiple causations through the root cause analysis process11 or other forms of failure-mode analysis. Consider reporting significant issues to well recognized external reporting systems.
Re-evaluate the applicability of security and confidentiality protocols as more medical devices interface with the IT network. Reassess HIPAA compliance on a periodic basis to ensure that the addition of medical devices to your IT network and the growing responsibilities of the IT department haven’t introduced new security and compliance risks.2
Contributing to these actions for successfully implementing and maintaining new technologies in support of patient safety were: Bona Benjamin, BS Pharm, and Karl F. Gumpper, BS Pharm, American Society of Health-System Pharmacists; David C. Classen, M.D., CSC Consulting, Inc.; Donald Mon, Ph.D., American Health Information Management Association; Tony Montagnolo, M.S., and Ronni Solomon, J.D., ECRI Institute; Ronald A. Paulus, M.D., Geisinger Health System; and Patricia Wise, R.N., Healthcare Information and Management Systems Society.

References
1 Pederson CA, Gumpper KF: ASHP National survey on informatics: Assessment of the adoption and use of pharmacy informatics in US hospitals. American Journal of Health System Pharmacy, 2008; 65:2244-64

2 ECRI Institute: Coping with convergence: a road map for successfully combining medical and information technologies. Health Devices 2008 October; 37(10):293-3

3 Weiner, JP, et al: “e-Iatrogenesis”: The most critical unintended consequence of CPOE and other HIT. Journal of the American Medical Informatics Association, May/June 2007, Vol 14 Number 3:387-388

4 Institute for Safe Medication Practices (ISMP): ADC survey shows some improvement, but unnecessary risks still exist, ISMP Medication Safety Alert!, January 17, 2008, http://www.ismp.org/newsletters/acutecare/articles/20080117.asp (Accessed July 7, 2008)

5 AHC Media LLC: ISMP warns of errors with ADCs, Healthcare Risk Management®, July 2008, Vol 30 Number 7:80-81

6 AHC Media LLC: ISMP survey shows risk of using ADCs, Healthcare Risk Management®, July 2008, Vol 30 Number 7:81-82

7 Institute for Safe Medication Practices (ISMP): Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets, April 2008, http://www.ismp.org/Tools/guidelines/ADC_Guidelines_Final.pdf (Accessed July 7, 2008)

8 Campbell EM, et al: Types of unintended consequences related to computerized provider order entry. Journal of the American Medical Informatics Association, September/October 2006, 13(5):547-556

9 Van Der Sijs H, et al: Turning off frequently overridden drug alerts: Limited opportunities for doing it safely. Journal of the American Medical Informatics Association, July/August 2008, 15(4):439-448

10 Bates DW, et al: Reducing the frequency of errors in medicine using information technology. Journal of the American Medical Association, 2001, 8:299-308

11 Koppel R, et al: Role of computerized physician order entry systems in facilitating medical errors. Journal of the American Medical Association, 2005, 293:1197-1203

12 Joint Commission Resources: Using Technology to Improve Medication Safety, 2005

13 Patterson ES, et al: Improving patient safety by identifying side effects from introducing bar coding in medication administration. Journal of the American Medical Informatics Association, 2002, 9:540-553

14 Han YY, et al: Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics, 2005, 116:1506-1512

15 Ash JS, et al: Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. Journal of the American Medical Association, 2003, 11:104-112

16 Aspden P, et al: Preventing medication errors. Institute of Medicine of the National Academies, 2006

17 Ernst ME, et al: Medication discrepancies in an outpatient electronic medical record. American Journal of Health System Pharmacy, 2001, 58:2072-2075

18 Nebeker JR, et al: High rates of adverse drug events in a highly computerized hospital. Archives of Internal Medicine, 2005, 165:1111-11

19 Kilbridge PM, Welebob, EM, Classen, DC: Development of the Leapfrog methodology for evaluating hospital implemented inpatient computerized physician order entry systems. Quality and Safety in Health Care, April 2006,15(2):81-4

20 Kilbridge PM, Classen, DC: The informatics opportunities at the intersection of patient safety and clinical informatics. Journal of the American Medical Informatics Association, 2008;15:397– 407

Joint Commission Resources: Using Human Factor Engineering to Improve Patient Safety, 2005

Karsh, B: Beyond usability: designing effective technology implementation systems to promote patient safety, Quality & Safety in Health Care, 2004; 13:388-394

United States Pharmacopeia: Examining errors prevented by and associated with BCMA. USP CAPSLink, May 2007, http://www.usp.org/pdf/EN/patientSafety/capsLink2007-05-01.pdf

United States Pharmacopeia: Improving the safe use of automated dispensing devices. USP CAPSLink, January 2007, http://www.usp.org/pdf/EN/patientSafety/capsLink2007-01-01.pdf

Rothschild JM, et al: A controlled trial of smart infusion pumps to improve medication safety in critically ill patients, Critical Care Medicine, March 2005; 33(3):533-40

* The 2009 standards have been renumbered as part of the Standards Improvement Initiative.© 2008 The Joint Commission, All Rights Reserved. Agency for Healthcare Research and Quality • 540 Gaither Road Rockville, MD 20850 • Telephone: (301) 427-1364
NOTA DEL BLOG: Esta información se provee sólo en idioma inglés, si Usted necesita una traducción por favor comunicarse al mail: cerasale314@gmail.com. El objetivo de este BLOG es proveer y facilitar el intercambio de información que optimice las pautas de gestión asistencial y sanitaria en el ámbito de la SALUD PÚBLICA. Tal lo hemos expresado en la nota propiedad de INTRAMED sobre las condiciones necesarias para la publicación de información científica, la información que se difunde desde Estados Unidos de Norteamérica hacia el mundo, en idioma inglés, sobre estrategias que permitan establecer escalas de alertas tempranas en los procedimientos asistenciales como en los sanitarios, es un aporte gratuito que se traduce en un beneficio práctico para todos los miembros del equipo de salud, en cualquier lugar del mundo. Cerasale. Enero, 2009.

FDA's Sentinel Initiative

Topics on this Page
Introduction
News Updates
What Is FDA Doing?
Consumer Information
Introduction On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety.

The Sentinel System will enable FDA to query multiple, existing data sources, such as electronic health record systems and medical claims databases, for information about medical products. The system will enable FDA to query data sources at remote locations, consistent with strong privacy and security safeguards. Data sources will continue to be maintained by their owners.

This historic new system will strengthen FDA's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health. Such a system could also ultimately facilitate data mining and other research-related activities.

As envisioned, the Sentinel System can be achieved with minimal transfer of data, using tools and processes that will ensure the protection of patient information.

News Release
FOR IMMEDIATE RELEASE
Thursday, May 22, 2008
Contact: HHS Press Office: (202) 690-6343; FDA Press Office: (301) 827-6242; CMS Office of Media Affairs: (202) 690-6145

New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Secretary Leavitt said. “We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”

In a white paper released by the FDA today, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.

A CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis.

The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality health care. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.

FDA’s Proposed Sentinel System Will Strengthen Safety Monitoring of Drugs and Other Medical Products

The new FDA white paper, titled “The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety,” describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html. The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.

“With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” said FDA Commissioner Andrew C. von Eschenbach, M.D. “The era of ‘wait and see’ is going to become the era of ‘tell me right now.’ By harnessing the world’s most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product’s performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”

Creating an active surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.

Access to CMS Data Will Facilitate Public Health and Safety Research and Quality Initiatives

“We look forward to working with the FDA on the Sentinel Initiative,” said CMS Acting Administrator Kerry Weems. “There’s a clear nexus between the data collected through Medicare’s prescription drug program and the FDA’s role in protecting the public from adverse events. The public health and safety benefits from this cooperative venture with the FDA will be substantial.”

Weems noted that CMS’s most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality (http://www.ahrq.gov/news/nn/nn051607.htm). Medicare beneficiaries’ high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the FDA’s new Sentinel Initiative.

The Medicare Prescription Drug Benefit data, linked to Medicare inpatient and outpatient claims data, will allow the creation of a highly robust HHS database as the prototype for the Sentinel System. Publication of the Medicare Part D Claims Data Rule enables the FDA to use Part D claims data as the FDA explores drug safety questions related to particular products. Medicare’s Part D prescription drug program, implemented in January 2006, has generated claims data on medications used by the more than 25 million beneficiaries with prescription drug coverage under the benefit. Linking these data on prescription drug use to other Medicare claims information, including diagnoses, medical treatments, hospitalizations, and physician services, will provide the FDA, other agencies, and researchers with a powerful new tool to investigate potential drug safety problems and questions about health outcomes. With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation.

Publication of the final rule today will enable CMS to use Medicare Part D claims data for research, program oversight and evaluation, care coordination, quality improvement, and performance measurement initiatives. In compliance with beneficiary privacy protections, as required by the Federal Privacy Act and HIPAA regulations, and while protecting commercially sensitive data, Medicare drug claims will be linked to other Medicare information on patient care, such as hospitalizations and physician visits, and made available to other federal agencies, state Medicaid programs, researchers, and beneficiaries for their personal health records.

CMS will be developing guidelines and workshops to inform researchers on how they can request these data.
The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp
U.S. Department of Health & Human Services · 200 Independence Avenue, S.W. · Washington, D.C. 20201

Sentinel System to Monitor Medical Product Safety

The Food and Drug Administration (FDA) has unveiled plans for the Sentinel Initiative, a strategy to create and implement a national, integrated, electronic system for monitoring medical product safety.

The resulting "Sentinel System" will strengthen FDA's ability to track how drugs and medical products perform once they go on the market. Ultimately, this system will help monitor medical products throughout their entire life cycle and thus better ensure the protection and promotion of public health.

The Sentinel Initiative is one of the efforts announced by Health and Human Services (HHS) Secretary Mike Leavitt on May 22, 2008, to improve and enhance patient safety and the quality of medical care into the 21st century.

The Sentinel System will

enable FDA to have access to a variety of electronic data sources to identify possible adverse events once a drug or medical product has been approved for use, while protecting patient privacy use tools and processes that ensure the protection of personal and proprietary information support research and epidemiology studies, as well as FDA's existing risk identification and analysis processes

Building on Existing Systems
The Sentinel System will be created through public/private partnerships. These partnerships will make it possible for the agency to access large, existing electronic databases without compromising patient privacy.

The system has unparalleled potential for supporting many other activities critical to a modern health care system. For instance, health researchers may be able to one day use the query system to evaluate the outcomes of various treatments given to different patients in different locations.

Meeting FDAAA Requirements
The Sentinel System will fulfill some requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which includes provisions calling for the development of such a system.

In addition to creating the new system, the Sentinel Initiative will also explore joining the emerging Nationwide Health Information Network (NHIN). The NHIN will connect clinicians across the health care system and enable the sharing of data as necessary with public health agencies. It will help ensure that treatment decisions are supported by the most current and complete data.

FDA has been meeting with a variety of potential partners with the goal of exploring how best to establish the public/private partnership. There will be a number of forums for public discussion of this initiative.

The Initiative is described in an FDA report titled, "The Sentinel Initiative—A National Strategy for Monitoring Medical Product Safety." It is available online at www.fda.gov/oc/initiatives/advance/sentinel/
Date Posted: May 22, 2008