July / August 2008
NEWS ITEMS FROM SOURCES WORLDWIDE
Pulse
ASQ Aims to Help Defuse Healthcare Checklist Controversy
The American Society for Quality (ASQ) has submitted recommended guidelines to the Office of Human Research Protections (OHRP) a division of the U.S. Department of Health and Human Services (DHHS) in response to a concern about a ruling that could threaten to disrupt quality initiatives in healthcare institutions across the country.
The ruling put a stop to data collection on a Johns Hopkins-led program being carried out in Michigan hospitals. The program was to determine the effectiveness of a simple checklist of five basic intensive care infection-control practices designed to reduce central venous catheter-related infections in hospital ICU patients. In a February 15 announcement, OHRP stated that it had reached a settlement with Johns Hopkins and the Michigan hospitals and concluded that the case was closed, stating that they had offered new guidance for future quality improvement research. But ASQ's reading of the statements left doubts that the issue was settled and led to a meeting with and an invitation from OHRP to develop recommendations on how to best provide regulatory authority over healthcare quality initiatives.
Following a meeting with OHRP, a guidelines document was prepared by Dr. Robert Burney, MD, of the ASQ Healthcare Division, with input from other Healthcare Division members. The guidelines classify typical healthcare quality improvement and process improvement activities according to the degree of risk they pose to patients, using this as the criterion for deciding if these activities should be governed by the Institutional Review Boards that oversee patient safety in clinical research.
"We are pleased that OHRP is open to engaging in dialog and reviewing our recommendations on this difficult subject where there are gray areas," said ASQ President Mike Nichols. "ASQ and its Healthcare Division believe our input will help OHRP in its challenging task of applying its regulations to protect patients while not impeding quality improvement initiatives."
ASQ's concerns are explained in a position statement on the issue, available at www.asq.org/advocacy/issues-actions/20080212-healthcare-checklists.html. Additional background information on the Michigan hospitals initiative is contained in an analysis by the ASQ Healthcare Division at www.asq.org/health/articles/saving-lives-enshrining-bureaucracy.pdf.
The Joint Commission Announces 2009 National Patient Safety Goals
The Joint Commission has announced the 2009 National Patient Safety Goals and related requirements for each of its accreditation programs and its Disease-Specific Care Certification Program. The National Patient Safety Goals promote specific improvements in patient safety by providing healthcare organizations with proven solutions to persistent patient safety problems. These Goals apply to the more than 15,000 Joint Commission-accredited and -certified healthcare organizations and programs.
Major changes for 2009 include three new hospital and critical access hospital requirements related to preventing deadly healthcare-associated infections due to multiple drug-resistant organisms (MDROs), central line-associated bloodstream infections, and surgical site infections. These additions build on an existing National Patient Safety Goal to reduce the risk of healthcare-associated infections, and recognize that patients continue to acquire preventable infections at an alarming rate within hospitals. The new requirements related to central line-associated bloodstream infections also will take effect for ambulatory care facilities and office-based surgery practices, home care organizations, and long term care organizations. In addition, prevention of surgical site infections will be a new requirement for ambulatory care facilities and office-based surgery practices. These new infection-related requirements have a one-year phase-in period that includes defined milestones, with full implementation expected by January 1, 2010.
"The 2009 National Patient Safety Goals represent ongoing opportunities for improvement that can immediately benefit patients," says Mark R. Chassin, MD, MPP, MPH, president, The Joint Commission. "By taking action to consistently meet the Goals, healthcare organizations can substantially improve patient safety in America."
A revision of the requirements for the existing medication reconciliation Goal is based on feedback obtained from a Medication Reconciliation Summit convened in late 2007 and is included in the 2009 update. Other changes to the National Patient Safety Goals include a requirement to eliminate transfusion errors related to patient misidentification in hospitals, critical access hospitals, ambulatory care facilities and office-based surgery practices. New requirements for several programs focus on engaging patients in their care regarding infection control, prevention of surgical adverse events, and the patient identification process.
The requirements associated with the existing Universal Protocol, initiated to help prevent errors in surgical and non-invasive surgical procedures, were also improved for 2009. These changes, which address the topics of procedure verification, marking the procedure site, and conducting a "time out" immediately prior to starting procedures, were based on feedback received at the Wrong Site Surgery Summit in 2007. The Universal Protocol is used by hospitals, critical access hospitals, disease-specific care organizations, ambulatory care facilities and office-based surgery practices.
The development, annual review and modification of the National Patient Safety Goals, first introduced in 2003, is overseen by the Sentinel Event Advisory Group, a panel that includes widely recognized patient safety experts, nurses, physicians, pharmacists, risk managers and other professionals who have hands-on experience in addressing patient safety issues in hospitals and other healthcare settings. Each year, this panel works with The Joint Commission to undertake a systematic review of the literature and available databases to identify potential new Goals and requirements. The Joint Commission also conducts an extensive field review of candidate new Goals and seeks input from practitioners, provider organizations, purchasers, and consumer groups among others. The Joint Commission's Board of Commissioners approves the Goals and requirements each year. Compliance with the requirements is a condition of continuing accreditation or certification for Joint Commission-accredited and -certified organizations.
FDA and CMS Collaborate for Medical Product Safety
HHS Secretary Mike Leavitt has announced that efforts are 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 healthcare services."
In a white paper released by the FDA, 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 recently 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 healthcare. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.
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, MD. "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 healthcare 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."
"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."
Publication of the final rule 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.
The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp
PDC's "Partner in Patient Safety" Success Story Contest to Award $10,000 for Top Hospital Success Story
Precision Dynamics Corporation (PDC), the leading identification wristband company will reward hospitals that are taking innovative measures to better protect patients through its "Partner in Patient Safety" Success Story Contest. PDC will donate $10,000 to the foundation named by the hospital that submits the best patient safety success story, as chosen by a select judging committee. Three additional honorees will be awarded $1,000 each in PDC products.
PDC along with its contest partner Patient Safety & Quality Healthcare will announce the winning entry on November 10th through a national publicity and press release campaign. The winning entry and honorees will receive special coverage in the magazine, posting of the success stories on PDC's website, and awarding of certificates of excellence in patient safety. The contest ends August 4, 2008.
In selecting the winning success story, emphasis will be placed on ways that clinicians use innovative products and effective processes to prevent medical errors and improve patient safety. The contest is open to all USA hospitals and healthcare facilities. More information, complete rules and criteria are located on the website at: www.pdcorp.com/patientsafety.
Persons can also obtain an award application via fax or mail by contacting Adrienne S. Lamm at 818-897-1111, ext. 1330.
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