Welcome to the Patient Safety Update eNewsletter
Editor: Philip L. Ronning
This issue sponsored by The Quality Colloquium

NIH Outbreak Report Increases Pressure for FDA Action on Antibiotic Policies
An outbreak of antibiotic-resistant bacteria resulted in a National Institutes of Health (NIH) report which has generated calls for the FDA to establish policies to spur the development of new products and other efforts to curtail the growing resistance to current antimicrobials. The report, "Tracking a Hospital Outbreak of Carbapenem-Resistant Klebsiella pneumoniae with Whole-Genome Sequencing," published in Science Translational Medicine, notes that the Klebsiella pneumoniae outbreak affected 18 patients, with 11 eventually dying. According to the recently enacted Generating Antibiotic Incentive Now Act the FDA must set policies on antibiotic development including guidance on the development of pathogen-specific drugs. The NIH researchers, who said results show a better way to control outbreaks, used genomic sequencing to analyze the patient, the hospital environment, and the way in which the outbreak spread. Rep. Louise Slaughter (D-NY) said, "We must do everything possible to stop superbugs from developing in the first place. The good folks at NIH did everything they could to prevent the spread of antibiotic-resistant bacteria, and it still wasn't enough. I can't think of a clearer case for preventing the overuse of antibiotics and preserving medicine for the protection of human health. What we have here is a canary in the coal mine." (Inside Health Policy, August 31, 2012)

Project Taps Engineers, Families for Hospital Safety
The Gordon and Betty Moore Foundation has awarded Johns Hopkins Medicine's Armstrong Institute for Patient Safety and Quality an $8.9 million grant. Peter Provonost, MD, the Institute's Director, said the grant will be put toward a project focused on reducing preventable patient harm by working with engineers to create systems which can share information among a variety of medical devices used in the intensive care unit. This type of communication can help avoid unnecessary tests, reduce medication errors and improve the patient's overall experience. The Institute of Medicine and the National Academy of Engineering are both assisting in the research project. Gordon Moore, founder of both Intel and the Gordon and Betty Moore Foundation, said in announcing the grant that this grant is the first step in a planned $500 million effort over ten years to improve patient safety and family engagement in the nation's hospitals. (USA Today, August 8, 2012)

Seniors Advocates Pleased Nursing Home Reg Review Focused on Patient Safety
Patient advocates, according to the National Consumer Voice for Quality Long Term Care, were pleased to hear CMS officials say they are backing off plans to reduce the regulatory burden on nursing homes and instead will review regulations with an eye toward improving quality and safety standards. An email from Sarah Wells, the Executive Director of Consumer Voice, said, "On Wednesday, August 1st, the Centers for Medicare and Medicaid Services (CMS) shared with the National Consumer Voice for Quality Long-Term Care (Consumer Voice) and other leading long-term care advocates that burden reduction is NOT the agency's priority in its current review of federal nursing home regulations. CMS stated that they will review the regulations for the sole purpose of improving quality and safety standards for residents." (Inside Health Policy, August 22, 2012)

6 Bay Area Hospitals Penalized for Threats to Patient Health and Safety
The California Department of Public Health announced administrative penalties against six Bay Area hospitals totaling $375,000. The six were among the 14 hospitals fined a total of $825,000. Since 2007, California has issued 235 penalties to 135 hospitals for patient-endangering medical errors. For violations before 2009, the fine was $25,000 per violation. Since 2009, fines start at $50,000 and increase for repeat violations. (KTVU.com, August 30, 2012)

Sully Sullenberger Talks About Patient Safety
Chelsey B. "Sully" Sullenberger, best known for his 2009 landing of US Airways flight #1549 in the Hudson River, has become a vocal advocate for not only airline safety but also patient safety. He argues that healthcare should learn from the airline industry and advocates the formation of an independent agency similar to the National Transportation Safety Board (NTSB), arguing that if airline safety was at the level of patient safety "the skies would be empty." A link to a conversation about patient safety with Sullenberger can be found at this Stanford School of Medicine site. Software supporting iTunes is required and is available through the link. (SCOPE, August 23, 2012)

Bristol-Myers Ends Development of Hepatitis C Drug after Test Patient Dies of Heart Failure
Bristol-Myers Squibb announced on August 23, 2012 the scrapping of a potential hepatitis C treatment following the death by heart failure of a participating patient. "The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients," said Elliott Sigal, Bristol-Myers' chief scientific officer. The Company's other new hepatitis C drug is a compound labeled daclatasvir and has begun late-stage testing, the last step before a drug maker submits a product to regulators for approval. Victrelis from Merck & Co. and Incivek from Vertex Pharmaceuticals Inc. and Johnson & Johnson, the first two hepatitis C drugs in over two decades, were approved last year. Both significantly improve the cure rate over the longtime standard of care, a regimen "with nasty, flu-like side effects that takes several months and still doesn't cure many patients." (Washington Post, August 23, 2012)

Patient Safety Law Protects Some Documents in Court Case
An appellate court in New Jersey has upheld a state law protecting the confidentiality of documents related to medical errors in order to improve patient safety. The case involved a request for disclosure of investigative and peer review records. New Jersey passed the Patient Safety Act (PSA) in 2004 designed to improve patient safety which establishes a process for confidential reporting of medical errors and near-misses. The trial court allowed disclosure of one of two documents; both sides appealed. The Appellate Court ruled both documents protected by the PSA. Each state establishes and interprets rules for privileged information and discoverability. These laws and regulations are subject to ongoing challenge and interpretation. (amednews.com, August 29, 2012)

Cardiologist Issues Alert on St. Jude Heart Device
Robert G. Hauser, MD, a cardiologist from Abbott Northwestern Hospital in Minneapolis who studies the safety of heart devices, said surgeons should stop using St. Jude pacemaker lead wires coated with Optim. Hauser notes that a "troubling number of cases" have been reported to the FDA. St. Jude is defending the safety of Optim and its current defibrillator lead known as Durata. The FDA has recommended that patients who received an earlier generation of St. Jude leads undergo imaging tests to determine if the device is failing. (New York Times, August 21, 2012)

Health Care Quality: The Clinician's Primer

Colleagues from Jefferson School of Population Health in Philadelphia have published a book entitled Health Care Quality: The Clinician's Primer. Published by the American College of Physician Executives, the book aids in learning "how to apply quality measures, how to evaluate quality, perspectives on value and value-based purchasing, and a look at the national agenda for improving quality and safety."

David Goodman of Dartmouth Discusses Efforts to Study Care Quality across Patients' Lifetimes

In this video, David Goodman, MD, professor at Dartmouth School of Medicine and co-director of the Dartmouth Health Atlas of Healthcare, discusses Dartmouth's ongoing research on end-of-life care noting that most patients would prefer to spend time at home and avoid painful procedures rather than receiving aggressive care. (California Healthline, August 29, 2012)

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Boot Camp I: Quality and Safety Overview

David B. Nash, MD, MBA
Dean, Jefferson School of Population Health, Philadelphia, PA