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Issues & Legislative Committee Reports

April 9, 2009

JCAHO / GPO Oversight Committee

Joint Commission:  

Television Show “ER” used the “Safe Surgery Checklists and Timeout” during their March 12, 2009 episode.

JCAHO website lists Dr. Mehmet Oz’s book “ You The Smart Patient” as a reference for the Patient Checklist and 8 ways to avoid medical mistakes.  Source Oprah.com
2009 National Patient Safety Goals for Hospitals were renumbered.
JCAHO announces no new NPSGs fro 2010

Association & Board Update

New CMRP Exam Introduction Rescheduled
FYI - The new CMRP exam introduction has been rescheduled from July to January 4, 2010. The new CMRP handbook and Self Assessment Exams will be available three months prior to that date. The change in the date was based on feedback received at the board meeting.

CMRP presentations at chapter meetings and at the conference do NOT need to be changed to follow the new content outline since the exam won't be released until January 2010. The best rule to follow would be to have presentations adapted to the new outline three months prior or October 1.

Online Registration for Annual Conference
Online registration for the Annual Conference & Exhibition is now available. This year the conference is in Tampa Florida, and will run from July 19th through the 22nd. Information about the conference and registration information is available on line.
To learn more about the conference or to register click on this link : www.ahrmm09.org

Technology / Merging Technologies Impact

Opus Healthcare to deploy OpusMobility® remote patient monitoring system
Opus Healthcare Solutions Inc. (Austin, TX) will deploy the OpusMobility® Web-based smart phone application systemwide at Universal Health Services Inc's (King of Prussia, PA) acute-care hospitals, and provide continued support, ongoing enhancements, and rollout of the OpusClinicalSuite®. The application runs on all smart phone devices and enables physicians to continue monitoring patients outside of the hospital. The 2nd generation OpusClinicalSuite® is one of the few Web-based (vs. web-enabled) clinical information systems available and includes clinical documentation, order management, computerized physician order entry, medication administration charting and checking, a clinical data repository, a patient dashboard, and physician Web access. The system is built on a secure Web architecture, and capable of sharing clinical data through an integrated HL7/XML interface engine. For more information, see www.opushealthcare.com <http://www.opushealthcare.com>

Hill-Rom Company Inc (Batesville, IN) and TeleTracking Technologies Inc (Pittsburgh, PA) signed a strategic development agreement to integrate Hill-Rom's NaviCare® Nurse Call system and TeleTracking's Capacity Management Suite™ powered by TeleTrackingXT™ to incorporate patient flow technology and nurse communications solutions. The two companies also established a joint sales and marketing arrangement to take advantage of the combined market reach of the two companies as they take patient flow and nurse communications solutions to market. The two companies also will jointly market and sell the combined portfolios of the Capacity Management Suite powered by XT and the NaviCare Platform for Clinical Connectivity.

Intel, General Electric To Jointly Develop Health Care-Related Technology
On Thursday, Intel and General Electric are expected to announce that they will work together on new health care technology, such as health information technology and home health care monitoring, the Wall Street Journal reports.

According to the Journal, Intel in recent years has put emphasis on technology that monitors sick or aging people at home and then transfers their information to physicians over the Internet. Intel needs a partner to break into the market further, and GE -- which sells a monitoring system that can track a person's daily activities at home and send information to health care providers -- is a "logical" choice, according to the Journal.

GE uses Intel's microprocessing chips in some of its equipment, though the company would benefit from partnering with a technology company like Intel, the Journal reports. In a September meeting, GE Healthcare CEO John Dineen said that while IT represented less than 10% of its business, it would be major part of the company's future growth (Clark/Glader, Wall Street Journal, 4/2). Reuters/Boston Globe reports that GE's health care business represented $2.9 billion of $17.4 billion in sales in 2008 (Reuters/Boston Globe, 4/1).

Marc Holland, research director at Health Industry Insights, said that President Obama and members of his administration have been pushing "telemedicine," which puts Intel in "a very good position" (Wall Street Journal, 4/2).

GE Expansion
In related news, production on new imagers for digital mammography machines is expected to begin this summer at a $165 million GE facility currently under construction in New York state, the Albany Times Union reports. The facility will employ 150 people.

According to a study by the American College of Radiology Imaging Network and funded by the National Cancer Institute, digital mammography machines can cost several hundred thousand dollars each, but are considered more accurate than film X-ray machines.

GE spokesperson Thomas Feist said the company also is developing new technology for several other products, such as cardiovascular imaging (Anderson, Albany Times Union, 4/2).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Bioject Announces FDA Market Clearance for the Zetajet Needle-Free Injection Therapy System
PORTLAND, Ore.--(BUSINESS WIRE)--Apr 6, 2009 - Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free injection therapy systems, today announced that the U.S. Food and Drug Administration (FDA) has granted market clearance for the Zetajet™ Needle-Free Injection Therapy System. Bioject's new Zetajet system is the latest advance in needle-free delivery systems, offering a significant array of unique product features and patient benefits that can provide highly competitive differentiation to a wide variety of injectables market segments.

The Zetajet™ Needle-free Injection Therapy System is a compact, spring-powered, needle-free injection device. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet™ uses jet force to propel a finely dispersed stream of injectable medication into the subcutaneous or intramuscular tissue without the use of a needle.

The syringe assembly has a unique ”auto-disable” feature that prevents re-use of the syringe. The plunger is pre-assembled into the syringe and can be used for reconstitution and other pre-injection tasks.

A custom molded exterior, providing a multitude of ergonomic options, can be added to achieve specific attributes needed for different clinical applications. The exterior molding of the device can be customized in shape, texture and color for a wide spectrum of therapeutic and patient segments, offering the ultimate in selective branding. For instance, devices designed for geriatric or arthritic users can have features added to the exterior of the device that make the device easier to handle, reduce winding effort, and require less activation force without actually changing the core device.

The self-powered spring device uses an auto-disable syringe, and it is ideal for use in mass immunization programs world-wide. The auto-disable feature dramatically reduces the risks of both the spread of disease from accidental needle-stick injuries and the re-use of a syringe or needle, and prevents possible contamination of syringes and vials. With these unique advances in delivery technology, the Zetajet™ is anticipated to provide the optimal injection therapy system for both developed and developing countries to provide a safer and more effective method for delivering their parenteral injectables.

“This new state-of-the-art technology offers features that make this the perfect injection system for many areas of medicine where injectables are given. Such areas may include self injected pediatric vaccines, therapeutic medications and fertility injections, as well as injectables used for chronic conditions, such as Hepatitis C, and many other professional and self-administered injectables,” said Dr. Richard Stout, Executive Vice President and Chief Medical Officer of Bioject.

“We are very excited to introduce this new and exciting technology to our current customers and patients as well as new collaborators, especially in areas such as developing world immunization programs where this will have distinct safety advantages and improve patient care.”

“We believe the introduction of the Zetajet™ will establish Bioject's needle-free technology offering as the new standard of care in the marketplace and could significantly drive global demand for this delivery option. With the FDA 510(k) clearance achieved, we are now determined to find the best strategic partners with whom to introduce the Zetajet™, in combination with the right therapeutics, in order to create highly differentiated products that maximally enhance the patient experience,” said Ralph Makar, President and CEO of Bioject.

About Bioject
Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies.
For more information about Bioject, visit www.bioject.com.

Boston Gamma Knife Center
The Boston Gamma Knife Center at Tufts Medical Center is the first and only Gamma Knife center in Massachusetts and Northern New England offering treatment with Leksell Gamma Knife® technology.

The Gamma Knife is an effective, non-invasive alternative to traditional brain surgery. Gamma Knife pinpoints targets with high doses of radiation, sparing normal, healthy tissue. Typically performed in a single outpatient treatment session without general anesthesia, this proven technique helps patients avoid incision, scarring, and long hospital stays, allowing them to return to pre-Gamma Knife activities.

Conditions Treated by Gamma Knife

Antibiotic Spacers Fill the Gap for People with Infected Hip Replacements
04/02/2009
Newly developed antibiotic spacers successfully eradicated infection in more than 90 percent of patients with total knee and hip replacements, and allowed them to be successfully re-implanted, according to a study published in the online edition of the Journal of Arthroplasty.

The study showed that antibiotic spacers, which prevent total bed rest and allow patients to move during the six or more weeks of antibiotic treatment, also facilitate complex revision surgery that is needed once the infection is gone,
“If the bacteria get in or on the metal or plastic (parts of a hip replacement), then the hip replacement should be removed and the area has to be thoroughly cleaned so the body can heal itself,” said Dr. Stephen Incavo, an orthopedic surgeon at The Methodist Hospital and the study’s lead investigator. “When you do this, the patient is left without a hip joint and has limited mobility for an extended period of time.”

Antibiotic spacers are made out of traditional bone cement, the same material used to attach knee and hip replacements.

The cement is filled with a high dose of powder antibiotics; the antibiotics then leach out of the spacer over a six week period, delivering a high dose to the infected area. This not only fills the gap and heals the problem, but it also gives surgeons more space and soft tissue to work with later on. Additional antibiotics are also given intravenously to maximally treat the infection.

The spacers are left in for about six weeks during which time patients can use a walker or wheelchair to get around. In some cases, depending on the severity of the problem, a second spacer might need to be put in to completely rid the area of infection.

“Once the infection has been eradicated, we can go back in with new implants and once again replace the hip,” Incavo said. “In this study, no knee patients had a recurrence of infection and all were successfully re-implanted. There were also no reports of spacer breakage during the time they had them in place.”

With any operation, there can be complications and patients can develop an infection. This can happen shortly after surgery or over an extended period of time. Infections that occur right after surgery are easier to treat. Sometimes, however, the infection doesn’t show up until one or two years after surgery.

Symptoms of an infected knee or hip replacement include:
• Feeling feverish or having the chills.
• Reddish incision or swelling around the incision.

"Patients will have some pain with the spacers in place, but unfortunately that is what is required to fix the problem,” Incavo said. “Having the spacers in is not as comfortable as a true hip replacement, but it is better than strict bed rest or even being in traction.”

From start to finish, the process of fixing a diseased hip with the spacers takes about a year and will allow people to get back to performing the activities of daily living, pain-free.

Quality / Medication Errors / Safety Issues

“Quality Improvements at Area Hospitals” – Richard Callaway, M.D.,   Healthcare Ledger February 2009, Vol. 6, Issue 02
When it comes to patient safety and improvements in quality management and the overall standard of care in hospitals, the need is largely based on literature that has identified errors in medication prescription, physician ordering and hospital process and organization. According to a study by the Institute of Medicine, as many as 98,000 deaths a year are attributed to medical errors. According to the Institute for Healthcare Improvement (IHI) an estimated 15 million incidents of medical harm occur in American hospitals annually.  Between 40 and 50 incidents of harm occur for every 100 hospital admissions. With 37 million admissions in the US each year, this equals approximately 15 million harm events annually or 40,000 incidents of harm each day.
In response, IHI launched the “100, 00 Lives Campaign” in December 2004, which resulted in a national effort among 3,100 hospital to reduce medical errors and preventable deaths over an 18-month period. It was estimated that as a result of this initiative a total of 122,000 lives were saved. This success led to the “5 Million Lives Campaign” which attempted to protect patients from 5 million incidents of medical harm over a 2-year period ending in December 2008.

“Hospitals, health care agencies collaborate to improve care” Materials Management in Healthcare Vol. 18, No. 3, March 2009 – pg 3.
Hospital and the agencies that oversee them are learning that by working together they can meet challenges better than working alone. In January a group called QUEST (High Performing Hospitals Collaborative) marked its first anniversary with a renewed commitment to patient safety. This group includes 166 hospitals, a group purchasing organization, the Joint Commission, and the Institute for Healthcare Improvement. Members are looking for ways to fight catheter-associated urinary tract infection, MRSA and ventilator-associated pneumonia. According to an analysis, patient mortality could decline by 17% and care reliability could improve by 13% if the participants meet their 3-year performance improvement targets. QUEST is also contacting suppliers for help in improving care.  QUEST’s goals are consistent with those on the National Quality Forum: reduce adverse events and mortality, eliminate waste while ensuring appropriate care and increasing patient satisfaction.

FDA Reviews /  Government Updates

New Law Makes Millions of Children Eligible for Health Insurance
A new law signed by President Barack Obama reauthorizes the Children's Health Insurance Program and provides funding to extend free or low cost insurance to millions of uninsured children. The new law took effect on April 1. The U.S. Department of Health and Human Services encourages parents across the country to visit www.insurekidsnow.gov and determine if their children are eligible for health insurance provided through the Children's Health Insurance Program (CHIP).

You are subscribed to HHS.gov Spotlight for U.S. Dept. of Health & Human Services. This information has recently been updated, and is now available.

Federal Health Architecture Delivers Free, Scalable Solution Helping Organizations Tie Health IT Systems into the NHIN
April 6, 2009
The Federal Health Architecture is making software available as a first step to help public and private health information technology systems communicate to the Nationwide Health Information Network (NHIN), a federal initiative to facilitate the electronic exchange of health information.  More...
You are subscribed to HHS.gov News for U.S. Dept. of Health & Human Services. This information has recently been updated, and is now available.

Hospital employment down in March
Employment at U.S. hospitals fell 0.7 percent in March 2009 to a seasonally adjusted 4,709,900 people, the Bureau of Labor Statistics reported last week.

Colorado to deny payment for avoidable medical errors
Colorado Governor Bill Ritter issued an executive order last week directing the Colorado Department of Health Care Policy and Financing to craft new safety guidelines, including the denial of payment for avoidable medical errors.

AMGA launches interactive online compensation database
The American Medical Group Association has launched an online database containing salary and financial operations data from medical groups nationwide.

How well does Congress understand healthcare stimulus money?
The U.S. Congress has an inadequate understanding of the cost savings that healthcare information technology can provide, said a Pennsylvania Congressman at HIMSS09 Sunday.

Medicare funds State Health Insurance counseling programs for 2009
CHICAGO – The Hospital Uninsured Patient Discount Act will cap hospital bills and offer discounts for uninsured patients in Illinois.

The new law, to be regulated by the Attorney General's office, is designed to prevent discriminatory pricing based on patients' insurance status.

"This law reflects one of the most aggressive efforts by any state in the country to address healthcare accessibility and affordability for the uninsured, and given today's economic conditions, it could not come at a better time, said Attorney General Lisa Madigan. "As unemployment rates climb and record number of Illinois families struggle financially, this new law limits the financial strain caused by an unexpected illness or a medical emergency so that necessary hospital services are no longer out of reach for uninsured patients."

The law states that hospital charges to the eligible uninsured cannot exceed the costs of the services plus 35 percent. The new law also places an annual cap on the amount that hospitals can collect from eligible uninsured patients, limiting the total amount to 25 percent of the patient's family income during a 12-month period.

"We welcomed the opportunity to work with the Attorney General and state legislators on this landmark law for the uninsured, said Illinois Hospital Association President Ken Robbins. "This shows how trusting and respectful relationships among key stakeholders and our elected officials results in positive accomplishments to help people. As a critical part of the healthcare safety net for the uninsured, Illinois hospitals have always known first hand the plight of the uninsured. Now with growing numbers of people becoming unemployed and uninsured in the current economic crisis, this law meets a social need that is more critical than ever."

Those eligible under the law must fall within 600 percent of the Federal Poverty Level ($132,300 for a family of four in 2008) at non-rural hospitals and 300 percent of the Federal Poverty Level ($66,150 for a family of four in 2008) at rural hospitals.

Head Start, Early Head Start Programs to Receive Over $2 Billion in Recovery Act Funding
April 2, 2009

Dr. David Blumenthal will be leading the nation's implementation of a nationwide interoperable, privacy-protected health information infrastructure, according to a March 20, 2009 press release from the Department of Health and Human Services (HHS).
 
Blumenthal has been named national coordinator for health information technology at HHS, replacing Robert Kolodner.  The announcement comes at a strategic time with the country's push for the adoption of a modernized healthcare IT system.  The infrastructure is a key directive of the American Recovery and Reinvestment Act, which includes $19.5 billion for health IT investment.  Set to be fully in place by 2014, the infrastructure is projected to save $12 billion in federal healthcare costs over 10 years.
 
Dr. Blumenthal comes to the position with extensive experience in both healthcare and related legislation.  His most recent position was physician and director of the Institute for Health Policy at the Massachusetts General Hospital/Partners HealthCare System, while also serving as a professor of both medicine and healthcare policy at Harvard Medical School.
 
Already familiar with the Obama administration, Dr. Blumenthal was the President's senior health adviser during the Obama for America campaign.  He also served as a member on Senator Edward Kennedy's Senate Subcommittee on Health and Scientific Research about three decades ago.
 
There is little doubt in the minds of officials that Dr. Blumenthal will help the country reach the health IT goals slated in the Act, according to the press release.
 
"Dr. Blumenthal has the experience and the vision to help make this effort a reality," said HHS spokeswoman Jenny Backus in the announcement.  "As a practicing physician and a leading scholar on health information technology, Dr. Blumenthal is uniquely qualified to help America’s doctors, nurses, hospitals, and patients reap the benefits of a modernized health system."
 
Additionally, according to a March 23, 2009 Modern Healthcare article, others in the industry stand behind the decision, even though his immediate background is not in information technology.
 
"I think he is the right person at this point in time," stated Peter Basch, medical director for ambulatory clinical systems at MedStar Health, in the article.  "I think this next deployment needs to be care-centric rather than IT-centric.  So, I think it’s important that the next person from a federal level see the bigger picture."

http://www.whitehouse.gov/agenda/health_care/
http://www.hhs.gov/resource/index.html
http://www.hhs.gov/news/reports/index.html
http://www.fda.gov/opacom/7alerts.HTML
http://www.healthreform.gov/

Supply Chain Standards – GS1/HSCSC

AHRMM partnered with HIMSS to present a symposium on Supply Chain that focused on data standards at the HIMSS09 conference.

Articles that have premiered recently include:

Healthcare Purchasing News, April, 2009: 2009 Supply Chain IT Guide Issue. The main article - Crafting a supply chain standards stimulus package. Inset - Taking the standards case to the White House : Five supply chain experts outline GS1 recommendations for President Obama

Raising UDI’s profile on the flagpole: FDA meeting emphasizes economics, patient safety, supply chain efficiency
2009 Supply Chain IT Guide (This listing of supply chain IT software companies and products marks the first time that we have seen “GS1 Standards” listed as a product feature.)

Another Basics webinar featuring Jean Sargent is scheduled for May. Awareness seems to be on the rise.