Houston Medical Times May Issue

Page 1

Serving Harris, Galveston, Brazoria and Fort Bend Counties

HOUSTON

May Issue 2014

Inside This Issue

Food Prescription For Better Health See pg. 12

PHYSICIANS CAN LESSEN RISKS WHEN DEALING WITH DEVICE ALERTS AND RECALLS

By Jerrald R. Goldman, MD, Governor Emeritus, The Doctors Company, and Victoria H. Rollins, MHA, RN, Director, Patient Safety Programs, The Doctors Company

INDEX Healthy Heart................pg.3 Mental Health...............pg.5 Legal Health..................pg.6 The Frame Work.............pg.8 Age Well Live Well........pg.10

Device manufacturers often contact physicians with issues regarding implantable devices. Contact can range The FDA classifies recalls into three from an alert of issues with the device to categories: a U.S. Food and Drug Administration ∙∙ Class I recalls are the most serious. (FDA) Class I recall. They involve a health hazard with a reasonable probability that the use Implantable devices may be recalled of the product will cause serious for a variety of reasons: product efficacy, adverse health consequences or defects, sterility issues, risk to public death. health, or a violation of FDA regulations. Most recalls are carried out voluntarily by the manufacturer; however, the FDA ∙∙ Class II recalls present a remote possibility of adverse health can request a recall if the manufacturer consequences from the use of the does not take action on its own.

product. ∙∙ Class III recalls involve a situation where the use of the product is not likely to cause adverse health issues. Consider the following case study: The claim involved a 58-year-old female with a history of valgus knee arthritis. She had a total knee replacement. Five years after the replacement, the patient see Device Alerts and Recalls page 18

A SPECIAL RECOGNITION TO NATIONAL NURSES WEEK “Delivering Quality & Innovation in Patient Care

By The Menninger Clinic UH Biomedical Engineer Works to make Blood Transfusions Safer See pg.14

When Marilyn Warnock began her career more than 23 year ago, she knew for certain that nursing was the ideal profession for her. After all, like most nurses who are being celebrated during the annual National Nurses Week, Warnock has all of the right personality

traits –compassionate, nurturing and care-giving. But what distinguishes Warnock from most nurses who are profiled during this week-long observance is that she cares for patients who are struggling with debilitating diseases that impact the mind. A charge nurse at The Menninger Clinic, recognized as one of the nation’s leading psychiatric hospitals, Warnock not only provides patients the medical attention they need to fight their illnesses and get better, but she also has a very important job of fighting the stigma associated with mental health treatment. She is passionate about helping patients and their families recognize that a psychiatric diagnosis does not limit them from living a productive and fulfilled life.

“For psychiatric patients, the diagnosis and prescriptions are just one part of the puzzle,” said Warnock, who has worked in the mental health field for seven years. “As their frontline caregivers, in less than six weeks, nurses have to teach patients how to identify their behavioral triggers on their own, along with honing the psychological skills needed to be successful in their daily routines long after their treatment at see Nurses Week page 18

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May 2014

Houston Medical Times

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Houston Medical Times

Healthy Heart

AMERICAN HEART ASSOCIATION’S GO RED FOR WOMEN LUNCHEON SET FOR MAY 15, 2014 AT THE HOTEL ZAZA

in their lives, but we have more to do. This luncheon is key to the continuation of the awareness and fundraising that is so important to our future. We hope to have a full house!”

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dies from breast cancer each year, one in three dies of heart disease.

This year, the American Heart Association is proud to welcome NBC’s TODAY show nutrition and TODAY’s Joy Bauer to Deliver Keynote Address health expert Joy Bauer as the keynote By American Heart Association Staff Lori Armstrong MSN, RN, NEA-BC, Since 1984, more women than speaker. Bauer, author of multiple Senior Vice President/Chief Nursing men have died each year from heart New York Times bestselling books, In the last 11 years, more than Officer Texas Children's Hospital, disease and the gap between men expresses her passion for nutrition 627,000 lives have been saved from the and Go Red for Women Houston and women’s survival rates continues through What the Heck Are You No. 1 killer of women - heart disease Eating? a popular YouTube series - but the fight is far from over. Heart she creates and hosts, and a monthly disease affects more women than men health column she writes for Woman’s and is more deadly than all forms of Day magazine. In addition to Joy, cancer combined. To raise funds and Shannon Nickel will be featured as awareness for cardiovascular disease the 2014 “Passion Speaker”, and share and stroke research, the American her unique story. Heart Association will host its 11th annual Houston Go Red for Women Prior to the luncheon, attendees are Expo & Luncheon on Wednesday, invited to Shop Go Red, a marketplace May 15, 2014 at Hotel ZaZa Houston. setup outside the ballroom featuring Texas Children’s Hospital is the 2014 local and national vendors such Local Presenting Sponsor of this as Cheeky Vintage, Elaine Turner year’s luncheon. and Kendra Scott, with an array of Campaign Chair. “Women are to widen. The symptoms of heart products and services for sale. becoming more and more educated, disease can be different in women vs. “I couldn't be more excited about the concerned and involved in their own men, and are often misunderstood. Tickets are $250 per person, with strides we have made in generating health and the health of the women While one in 31 American women see Healthy Heart page 20 awareness about this disease,” said

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Houston Medical Times

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Rice’s Houston Area Health Survey: Insurance goes with better health By Amy Hodges Rice University

from the Houston Surveys (2001-2013).” People who have health insurance – The report is part of the Kinder Institute’s regardless of income, education, age, and Surveys of Health, Education and the Arts ethnic background – are significantly studies, funded by Houston Endowment more likely to report being in better Inc. It builds on findings from the 2012 health, according to a new report from Houston Area Health Survey, buttressed Rice University’s Kinder Institute for by rich data from the past 13 years of Urban Research that examined health health-related questions included in the disparities among Houstonians. Kinder Institute Houston Area Survey. Other key findings: household income, age and educational attainment beyond high school are each independently associated with better health; Hispanics and African-Americans have significantly higher odds of being in poor health; and the nature and location of neighborhoods play a critical role in the health of area residents.

The study’s key finding is that at all levels of education, income and age and among all ethnicities, people who have health insurance are more likely to report that they are in good health and that they have ready access to high-quality health care. Fifty percent of people with health insurance said their health was excellent or very good; only 35 percent of people without health insurance reported the Sociologist Stephen Klineberg, co- same. director of Rice University’s Kinder Institute for Urban Research, announced “Houston is home to the largest medical these findings in conjunction with the complex in the world and boasts some March 31 release of the report, “What of the highest standards for patient care Accounts for Health Disparities? Findings and medical research,” Klineberg said. “That’s why it’s especially troubling that

this city has one of the highest percentages – 19 percent – of children without health insurance. And Texas has the highest rate – 24 percent – of uninsured individuals in the entire country. “People without adequate insurance are severely limited in the types of health services they can access, and the research only fair or poor. Only 17 percent of U.S.suggests that this is to the great detriment born Anglos and 15 percent of Asians of their health,” he said. reported their health as fair or poor, while 21 percent of U.S.-born Hispanics, 28 Twelve percent of the survey respondents percent of U.S.-born African-Americans said that there was a time during the and 30 percent of Hispanic immigrants previous year when they were unable to reported their health as fair or poor. get the medical care they needed, mainly because of cost and inadequate insurance. Factors beyond the ethnic differences “Providing greater access to affordable in education and income (for example, health insurance would contribute to the vast discrepancies in family assets, improving the health and well-being of the the experience of discrimination and the Harris County population as a whole,” added stress of minority status) may well Klineberg said. be contributing to the more frequent health issues reported by the African“Unfortunately, the state of Texas so far American and Latino residents of Harris has chosen not to expand Medicaid to County, Klineberg said. the working poor, leaving a large gap in insurance coverage,” he said. Moreover, the study found that living in certain neighborhoods can The study also revealed that at all levels independently foster or impede healthof income, education and age, African- promoting behaviors, and exposure to Americans and Hispanics are significantly environmental toxins has obvious health more likely than Anglos and Asians to see Health Survey page 21 report that their current state of health is

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Houston Medical Times

Mental Health

Page 5

D I S C O U N T T I C K E T S N O W AVA I L A B L E A T G A LV E S T O N H I S T O RY. O R G

Are You a Procrastinator?

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Marilyn J. Ladin, LCSW-DCSW, Gerontologist & Psychotherapist

lives. (Nothing is worse, for a Parent, than for an Adult Child to try to tell them what to do next, when to do it, and to let the Adult Child do it for them). Sometimes you may have a Mom or a Dad who would LOVE to have their Kids assume some things. That depends, largely, on the ages of the Parents/ Children, the socio-economic level of same, the Ethnicity and the Race, and just plain how exhausted from the loss, someone is. All of these can affect the situation. One thing is for certain, we ALL need help going through a loss. Those who are experiencing Prolonged/ Delayed Grief experience these due to a number of factors. It is not just because one is a procrastinator. (I hope that gives some relief to some of you).

You are not alone! So many Humans are procrastinators. Remember from my last two articles, though, who we are, as Humans – our Styles of Being, we will be the same in Grief, in business, in Relationships, in life! Where there is procrastination, there can, also, be an avoidance of conflict or confrontation. Hmm…anyone you know?? One can, even, carry that out a bit further to say that one who is a procrastinator, could be conflict-avoidant, and could, also, have Other reasons for experiencing a difficult time making decisions. Again, prolonged or delayed Grief can be: I ask – does this sound familiar? Now, maybe, these items, separately, don’t ∙ One Parent dies and the other is amount to a hill of beans, to you. When just diagnosed with Cancer, or an we are involved with Grief, however, and acute anything. have the issues that come along with Grief (as we’ve seen in the last two articles), and have so much with which to contend, after ∙ One’s Child is ill with a progressive a loss (the business that comes with these disease and one’s Husband dies, life transitions), it can be nerve-wracking suddenly. to have to work/live/be in relationship of some kind with someone, who has all ∙ You’ve been caring for a dear Friend, three of these symptoms. who is dying, and your Child is picked up for drugs, DUI, murder, I just want to refresh your memory about or some such horrible occurrence. a few of the symptoms that Grief carries

into our lives: 1. Shock, numbness, forgetfulness 2. Anger, resentment, longing

One has been dealing with chemo treatments and your Caregiver is no longer available.

It is easy enough to understand, in print, 3. Cannot attend to matters that need but it is wholly different when it is YOU our attention (Spouses, Children, or someone whom you love, to whom Loves, Work, appointments, this has happened. schedules, cleaners, hygiene, cleaning the house, groceries, Church/ I cannot impress upon you, strongly Synagogue responsibilities)! enough, that there are many ways in That’s all – just our entire life (and which Grief can present its self. I would if someone says that they are not like for it to be more easily worked for your sake, and for the sake of experiencing some or all of the above, through, around you. Forewarned is forearmed, they are those who may be in Delayed/ all this case. Allow yourselves care from Prolonged Grief. They may say to you that in loving others and help (Professional they are not experiencing Delayed Grief your help, Spiritual help, Metaphysical help). It nor are they prolonging their Grief – they may be your Church/Synagogue Pastor, are getting along just “FINE!”. “Thank Priest, or Rabbi. It may be a Christian you!” Give them a couple more weeks Science Practitioner, Spiritual Guide or and then, check in with them to see how Psychotherapist, Psychiatrist, We all everything is going. Perhaps, at some benefit from allowing peopleetc.into our point, you will notice that they get a bit hearts so that we may move through Grief. prickly, because everything is going awry. That is your cue to rally the troops and see who might bring dinners, make time If anger presents itself, however, please to have breakfast or lunch, occasionally, get help to manage. Anger begets anger have folks give a call to check in, meet up and this would not be a time to lose for an evening; something. You’ll feel it. anything more, my Dears. Ask these folks if they mind if you help a bit. Don’t be pushy; don’t take over their

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Houston Medical Times

Page 6

Legal Health

Medicare Appeals Backlog Leaves Providers Treading Water: What’s Ahead? By Amy Lerman, Esq. Epstein Becker Green

When you need it.

The Medicare appeals process operates along a strict timetable that, in recent months, has been buried by an avalanche of requests for appeals hearings by Administrative Law Judges (ALJs). These administrative delays extend far beyond normal processing backlogs and have left many providers treading water waiting for appeals to be resolved. In February 2014, the Office of Medicare Hearings and Appeals (OMHA) hosted its first ever Medicare Appellant Forum to update appellants on the status of OMHA operations and discuss OMHA initiatives aimed at reducing the backlog of OMHA-level appeals.

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OMHA’s ALJs hear and decide three types of Medicare cases, namely: (1) traditional Part A / Part B appeals; (2) appeals associated with claims that may be reimbursable by both the Medicare and Medicaid programs (“dual eligible appeals”); and (3) appeals from decisions by contractors (e.g., Recovery Audit Contractors (RACs), Zone Program Integrity Contractors (ZPICs)) reviewing Medicare claims outside the traditional Part A / Part B process. Of these appeals, the most significant source of OMHA’s backlog results from the decisions of the RAC and ZPIC contractors. These hearings are part of Medicare’s third level of appeal. It is difficult for OMHA to manage the requests for hearings, as it is currently receiving 15,000 new requests for hearings each week. Something has to be done. OMHA recently changed its process due to the increased workflow. For requests for hearings received after April 1, 2013, OMHA has suspended the assignment of these requests until adjudicators become available. While seemingly efficient, this first in / first out process carries an estimated delay of up to 28 months for a hearing assignment and an additional 6 months delay for the hearing. OMHA is taking additional steps to

May 2014

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manage its workload. Programmatic initiatives include development of an adjudication manual to encourage uniformity among ALJs and using statistical sampling methods to speed up the appeals process. Technological initiatives are under way as well and include a Medicare Appeals Template System that will offer fillable templates to create individualized case documents and an Electronic Case Adjudication and Processing Environment to enhance workflow management and decision writing. Comments from Forum Attendees: OMHA Is Not the “True Problem” Forum attendees provided consistent feedback regarding their impressions of the “true problem” – namely, numerous denials at the Redetermination and Reconsideration levels of appeal. Attendees cited issues such as numerous denials for “technical” (versus “medical necessity”) reasons; refusals to reopen decisions; allowing “clinical inference” and failing to transmit full records when cases proceed to the next level of appeal. Looking Ahead OMHA’s actions will hopefully provide relief and resolve appeals more efficiently. Following the Forum, the American Medical Association and nearly 100 other physician organizations co-signed a letter urging OMHA to develop a comprehensive solution that is mindful of how “numerous appeals requirements, actual costs of filing appeals, and often lengthy delays undermine the ability of physicians to deliver patient-centered care.” OMHA plans to publish a Federal Register notice to solicit public comments regarding its efforts. Timing for publication of this notice is unknown. CMS issued a notice following the Forum prohibiting RACs from making post-payment additional documentation see Legal Health page 21


Houston Medical Times

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Page 8

The Framework

Memorial Hermann to Launch Major Renovation and Expansion to its Texas Medical Center Campus

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Texas Medical Center’s first hospital expands dedicated patient care area by 1 million square feet

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Memorial Hermann-Texas Medical Center, the first hospital to open in the world-renowned Texas Medical Center (TMC), soon will embark on a $650 million expansion and renovation of its campus. The “Master Plan” project will position the hospital to continue its leading role in driving the latest technology and procedures to provide for the growing healthcare needs in the Houston region.

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The Memorial Hermann Health System board unanimously approved the expansion in March 2014.

“The board approving this renovation and expansion recognizes that, as the Houston region’s only full-service health system, we must be prepared to stay ahead of the fast-growing advances in medicine, keep pace with the extraordinary growth of our medical staff and meet the health needs of our community,” said Dan Wolterman, president and CEO of Memorial Hermann Health System. “When completed, the Memorial HermannTMC Master Plan will enhance our ability to provide the highest-quality and safest healthcare for our community for many decades to come.” Katharine Precourt and Randy Herrera. Photo: Amitava Sarkar

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In addition, six shelled floors and six shelled operating rooms will be constructed to accommodate future growth with the potential of adding 264 beds.

“We recognize that our community will continue to grow and so will their health needs, so we’re designing the building with a forward-looking perspective to Construction on the Memorial meet those needs,” said Wolterman. Hermann-TMC Master Plan is scheduled to begin this summer. The expansion Founded in 1925, Memorial Hermannis expected to be completed in 2018. see The Framework page 21

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Highlighting the project will be the construction of a new, state-of-the-art patient care building, and an additional building that will include parking and infrastructure capabilities to support the new growth. The expansion also will provide the campus with:


Houston Medical Times

Page 9

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May 2014


Houston Medical Times

Page 10

Age Well Live Well

Older Americans Month and Help for Older Texans By Jeff Carmack, Managing Editor Department of Aging and Disability Services Communication Office

baby boomers who will need long-term care makes the need for advocates even more critical.

When President John. F. Kennedy designated May as Senior Citizens Month (today it’s called Older Americans Month), he may have had little idea how big a social issue the aging of the baby boomer generation would become.

Vickie Davison is a long-term care ombudsman in Houston. She went to nursing school but realized that it did not fit her passion for caring. “I found out that I didn’t want to be a nurse, but realized I really like seniors.” Someone mentioned the ombudsman program, When Congress created Older and she decided to give it a try. Americans Month in 1963, only 17 million Americans had reached their “Nursing school gave me insight into 65th birthday. Today, 6,000 Americans what these folks need – they need a reach that milestone each day and Texans voice. And that’s the ombudsman’s role,” 65-74 alone are projected to increase by Davison said. 60 percent in the next decade.

High-Tech Gadget Keeps 90-Year-Old Pearland Man Out of Hospital

Virtual Care Check dramatically improves patient outcomes and quality of life, while lowering health care costs using remote, cloud-based monitoring and testing system Pearland resident, 90-year-old James Weir practiced law for more than 50 years and isn’t letting his age or health problems stop him from doing exactly what he wants, anytime soon. Besides, going to the doctor is work and he says he is “allergic to work.”

After suffering from shortness of breath last December, Weir was admitted to Memorial Hermann Southeast Hospital and diagnosed with congestive heart failure. While he enjoyed the “delicious” chocolate milk and the pretty nurses, he “Staff – even when they’re doing their wanted to be back home with his family. The Texas Department of Aging and job well – often don’t have time to engage So, he was eager to try the Virtual Care Disability Services (DADS) sees a lot of with residents. They take care of one practical value in this year’s theme, “Safe resident, and then they need to care for Today, Healthy Tomorrow.” the next.” One example of how DADS serves older

Vivify Health. Patients, like Weir, with chronic medical conditions requiring frequent monitoring now have access to convenient, easy-to-use, mobile health care that sends updates to their health care providers at Memorial Hermann. “In terms of managing chronic diseases, improving care transitions, and reducing readmissions, Virtual Care Check is a real game changer,” said Pat Metzger, chief care management officer. “Memorial Hermann is looking at the future of health care and actively transforming it to revolve around the consumer.”

Ombudsmen, on the other hand,

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Texans is the agency’s Long-term Care Ombudsman Program, which advocates for quality of life and care for residents in nursing homes and assisted living facilities (ALFs).

have time for that all-important human connection. “When I’m in a room, I try to acknowledge that they’re a human Clinical Manager Kimberly Berg, R.N. stops by Pearland resident, 90-year-old James Weir’s home being in need of attention.

recently to check on him. “The nurse showed me how the Virtual Care Check system worked; straight-forward, simple questions and directions, easy to operate. Great technology is like driving a car versus a wagon,” said Weir.

“The thing that keeps me coming back is the residents,” Davison said. “I need to be needed; I need that feeling Check program offered by Memorial of satisfaction that comes from leaving Hermann. at the end of my shift and being able to say, ‘I did something good today.” “It’s like a doctor in your home, but without all the headaches of Houston To find out more about the volunteer traffic,” said Weir. “The nurse showed ombudsman program, please call 800me how the Virtual Care Check 252-2412 or visit www.dads.state.tx.us/ system worked; straight-forward, simple news_info/ombudsman/ Additionally, the huge number of aging questions and directions, easy to operate. Great technology is like driving a car Texas Department of Aging and versus a wagon.”

Kathy Bridgeman, DADS ombudsman developer, said that as our population ages and people live longer, most of us will be faced either with placing a loved one in a nursing home or an assisted living facility, or using their services ourselves. Many of the reasons for this life change revolve around safety as abilities – both mental and physical – decline.

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Patients are provided small, easyto-use tablet computers with a 4G wireless connection, weight scales, pulse oximeters, and blood pressure devices. Depending on the plan customized by a physician, patients log on and typically answer a daily health survey, keeping track of their vital signs. On the other end, health care providers monitor the patient’s progress remotely, make recommendations, and communicate with the patient and other members of the health care team.

Virtual Care Check is a remote patient monitoring system from Memorial Hermann that keeps patients out of “These new, mobile devices help our the hospital, dramatically improves patients take better care of their health quality of life, and decreases health by providing them a more active role care costs, according to co-developer

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see High Tech Gadget page 22


Houston Medical Times

Page 11

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Page 12

Houston Medical Times

Food Prescription for Better Health Baxter D. Montgomery, MD, founder of the Houston Cardiac Wellness Center

I have discovered a simple but amazing fact—when it comes to disease reversal and prevention, nutritional excellence is everything. As a cardiologist, I know that moderation is inadequate at best, and potentially deadly at worst. The vast majority of illnesses we suffer from are merely side effects of the bad food we eat. The body is designed to perform its own rebuilding and repairing when properly nourished. Once we eliminate foods that are harmful to our body, we allow it to start rebuilding itself in a way that restores its ability to carry out physiological functions in an optimal manner. How

we nourish our bodies is important and goes beyond keeping track of calories, protein, fats, carbohydrates, and portion sizes. Simply stated, the best form of medicine is optimal nutrition. During the years I have spent practicing internal medicine, cardiology, and cardiac electrophysiology, I have witnessed substantial advances in medical science. And yet today, I am seeing more young people than ever before plagued by chronic illnesses. I noticed over time that my LDL cholesterol had risen to 138 by the age of 38. It should have been less than 100 mg/dL. As a cardiologist with a genetic predisposition to diabetes and heart disease, I knew this was a significant problem and researched alternative ways to achieve optimal health and wellness. May 2014

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Healthcare professionals are trained to offer drugs and surgery. Collectively, we think of medications as near cure-alls. This is simply not true. Often, what is really going on with such treatments is just the masking of symptoms. Studies have shown that chronic illnesses are the direct result of our poor lifestyle choices, the most damaging of which is our food choices. We eat too many unnatural, processed foods that are toxic to our bodies, in place of foods that are natural and supply our bodies with what they need. We need a paradigm shift in our approach to healthcare. Our efforts need to start with removing unnatural foods from our diet, and replacing those foods with ones that are “natural,” as a way of reversing illness and facilitating health. Reversing and Controlling Disease Cardiovascular diseases (mainly heart

disease and stroke) are the leading causes of death in the U.S. Much of what happens to our arteries can be traced back to the foods that we eat. There are two major, mechanisms through which animal protein contributes to atherosclerosis that are well understood. First, increased intake of fat and cholesterol from animal foods contributes to buildup of fatty substances within the walls of the arteries. The fat and cholesterol molecules are “packaged” in special protein substances known as lipoproteins. These lipoproteins travel throughout the blood stream and their levels can be increased in part due to the amount of cholesterol and fat that is eaten. Special cells that are part of our immune system engulf see Food Prescription page 22


Houston Medical Times

Page 13

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Houston Medical Times

UH Biomedical Engineer Works to Make Blood Transfusions Safer

NIH-funded Technology for Separating Well-preserved Red Blood Cells from Potentially Harmful Materials By Lisa Merkl University of Houston

other potentially toxic materials.”

Shevkoplyas is working under an NIH Director’s Transformative Research Award to develop a simple device to separate healthy, well-preserved red blood cells from all the other material in the blood bag just before transfusion. Such grants support high-risk/high-reward projects Blood transfusions save millions of with potentially transformative impacts. lives every year. They are one of modern medicine’s absolute necessities. Without The system Shevkoplyas is developing them, for instance, routine surgeries will consist of two tubes that feed into would become life threatening. This a plastic device just a few inches in size. doesn’t mean transfusions are perfect, One tube will send blood into the device, however. There’s strong evidence that while another will send saline solution. In transfusions of red blood cells stored in the first step, the saline will wash harmful a refrigerator for prolonged periods of particles and the storage solution off the time can be dangerous or even deadly healthy red blood cells. Next, the entire mixture will be sent through an array of for some patients. precisely designed microfluidic channels, where the shape, size and flexibility of A biomedical engineer at the University of Houston (UH) is working to develop highly innovative technology to make blood transfusions safer. His work is supported by a $1.8 million grant from the National Institutes of Health (NIH).

TM

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This is because patients get more than just healthy, well-preserved red blood cells during a transfusion. They also get a number of potentially harmful materials. Materials beyond the needed red blood cells include the anticoagulant-preservative solution that keeps the blood cells alive during storage, as well as cells that have been irreparably damaged by processing the blood after donation and during storage. Additional materials include the remnants of burst cells, including free hemoglobin and microparticles that can contribute to inflammation and the formation of blood clots, as well as the byproducts of cellular metabolism, which is essentially cellular waste. The longer blood is in storage, the more these potentially harmful materials build up.

healthy red blood cells will allow them to be separated from the particles, damaged cells and storage solution. At that point, the healthy red blood cells, along with saline acting as a transport medium, can be transfused safely into the patient. Shevkoplyas emphasizes this will be no easy task, since microfluidic research usually involves fluids flowing through channels measuring less than a millimeter, with devices that can handle just a few drops per hour. With its series of interconnected channels, Shevkoplyas’ device aims to scale these microfluidic interactions up a thousandfold.

“That’s the big challenge,” Shevkoplyas said. “Adapting our understanding of microfluidics to a high-throughput device “Therapeutically, there’s absolutely no is not very simple, though we do have reason to transfer any of this into the some good data to show we can do it.” patient,” said Sergey Shevkoplyas, associate professor of biomedical engineering with While Shevkoplyas’ system faces UH’s Cullen College of Engineering. significant scientific and engineering “The only thing you need to transfuse hurdles, one of its biggest advantages into the patient is well-preserved red blood see Blood Transfusions page 22 cells. There’s no point to giving you these May 2014

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Page 16

10 Things You Need to Know to Respond to the Final HIPAA Rule By Mick Coady Principal in PwC’s Health Industries practice based in Houston

The Final HIPAA Rule issued on January 17, 2013 strengthens and expands patient rights as well as  enforcement. It contains a number  of significant changes, and among other things: 

 

∙∙ strengthens and expands the scope of the HIPAA privacy and security rules,

 

 



Any legal analysis of the Final Rule will likely leave you with the impression that the privacy and security provisions will require substantial operational changes for HIPAA-covered entities, their business associates and subcontractors. At the same time, there are numerous other new privacy and data protection laws in the US and globally that impact HIPAA and non-HIPAA organizations alike.1 Organizations that simply address the new rules without taking into account the other privacy and security requirements are at risk of creating a patchwork of processes and con¬trols that may ultimately prove less effective and unnecessarily expensive to build and

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∙∙ increases penalties for HIPAA maintain. violations, As a result, in order to help these organizations structure their ∙∙ extends potential liability and responses not only for HIPAA, but requirements for business also for the myriad of other recent associates and subcontractors, privacy and data protection laws and standards, PwC offers the following ∙∙ enhances patient privacy 10 suggestions to consider when protections and requires planning the path forward. mandatory changes to Notices of Privacy Practices, which #1 – The Stakes Have Changed have specific redistribution Communicate New Requirements, requirements, Need for Changes and Resources to Senior Management. ∙∙ creates a new presumption that a reportable compromise has Prior to the HITECH Act, most occurred under HIPAA’s federal HIPAA enforcements often led notification law for breaches of only to corrective action plans, with protected health information penalties rarely assessed. Yet, based (PHI) unless a new, specific on changes included in the HITECH assessment can demonstrate Act and the Final HIPAA Rule, the see HIPAA Rule page 17 “little probability.”

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HIPAA Rule

Continued from page 16 stakes have changed. The Final HIPAA Rule changes how breaches are punished. Penalties are increased based on a tiered basis first proposed in the HITECH law and are based on levels of culpability. As security and privacy becomes more and more strategic, compliance has begun to affect business opportunities related to new healthcare delivery models, technologies and channels. As a result, some organizational plans for investment, expansion, diversification and acquisition are being significantly—and often negatively impacted or slowed—if compliance requirements are not readily met. Companies that are fully compliant are using that status as a competitive advantage to enter new markets, countries and businesses, and to help speed the acquisitions process.

of EHR Systems to Address Requests defined to include genetic tests and for Records. information regarding family medical history) cannot be disclosed to health One of the more difficult compliance plans for underwriting purposes provisions from an operational (except for long-term care policies), point of view, covered entities must and provide an individual with access to their PHI electronically within 30 (iv) language advising patients of days if requested and if that data is their right to restrict disclosures maintained digitally. to health plans for products and services paid out of pocket in full. #5 - Update Notice of Privacy Practices and Redistribute to Patients #6 - Develop New Processes that Address Additional Restrictions on and Others. the Use or Disclosure of Personal Healthcare providers and their Health Information. business partners must make sure that their Notice of Privacy Significant modifications regarding Practices (“NPPs”) reflect the various prohibited uses and required

Under the breach notification requirements of the HITECH Act, “unsecured” PHI (which if compromised would lead to a breach notification) is defined to mean information not secured through a technology specified by HHS. many organizations are implementing or considering encryption to avoid being within the scope of the US state breach notification laws that have an exception for encrypted personal information and to comply with the encryption requirements under MA 201 for data in transit, wireless networks, laptops, mobile media and data at rest. #9 - Conduct a Data Element Inventory Beyond HIPA A for Compliance and Cost-Savings Purposes.

#2 - Business Associates Are Treated as Covered Entities and Must Now Conduct Risk Assessment, Enter Business Associate Agreements with Subcontractors and Enhance Safeguards Given that They Are Liable for Compliance Under HIPAA. Under the HITECH Act and the Final HIPAA Rule, business associates and now subcontractors will be required to comply with the HIPAA Privacy Rule and Security Rule, including the provisions related to physical, administrative, new HIPAA Rule policy changes and technical safeguards and policies and comply with the significant distribution and redistribution and procedures. requirements. Specifically, NPPs #3 – Contracting Companies, need to include: Including Business Associates, Are Assessing Vendor Practices and (i) language explaining that Compliance. individuals will be notified in the Given the number of vendor-related privacy breaches and regulatory requirements, organizations are enhancing and expanding processes for better oversight, including assessing pre-contract reviews and post-contract audits for all personal, consumer and employee information entrusted to third parties.

#8 - Implement Encryption and/ or Review Technologies and Data Classification Schemes Based on New Federal PHI Breach Notification Requirements.

case of a breach, (ii) modified disclosures around areas that now require authorizations, such as those used for marketing and fundraising efforts,

(iii) statements based on provisions of t he Genet ic Infor mat ion Nondiscrimination Act (GINA) #4 - Review Design & Functionality that genetic information (broadly

To locate PHI and to determine where heightened safeguards and the related breach notification obligations apply, many organizations have been developing personal information data element inventories to discover and catalog the applications, systems and business processes that collect, maintain and/or use one or more of the 18 data elements of personal information identified under HIPAA. authorizations outlined in the Final HIPAA Rule will require #10 - Establish and Roll-Out an organizations to revisit existing Integrated Privacy and Security processes governing those uses or Program Beyond HIPAA. authorizations. Many organizations are building #7 - Update Incident Response Plans an integrated privacy and security for General Privacy Considerations program that addresses not only and New Federal PHI Breach HIPAA and its new requirements, Notification Requirements. but also covers many of the key applicable US state and federal and The HITECH Act established a global regulations for data element federal security breach notification inventories. A key to success in law that requires notification of each managing privacy and security is to individual whose “unsecured” PHI develop a program that is updated to is reasonably believed to have been address today’s requirements and is accessed, acquired, or disclosed by adaptive to change as the healthcare an unauthorized third party—a industry progresses towards more “breach.”2 standardized environment.

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Houston Medical Times

Device Alerts and Recalls Continued from page 1

returned to the orthopedist complaining that her knee felt “loose” and was making a popping sound. After examination, the orthopedist recommended an arthroscopy to inspect and correct the instability. During the arthroscopy, the orthopedist replaced the plastic post with a slightly thicker post but noted that, although there was some medial wear in the device, the replaced post had not failed.

tracking over time. The use of UDIs may allow for more accurate adverse event reporting, reviewing, and analyzing so that problem devices can be identified and corrected more quickly. UDIs may also reduce medical errors by enabling healthcare professionals and others to identify a device and obtain important information concerning its characteristics more rapidly and precisely. It will also provide a standardized identifier to allow manufacturers, distributors, and A year later, the patient called the healthcare facilities to more effectively orthopedist after a fall. She was directed manage medical device recalls.1 to the emergency department, where she was evaluated by another orthopedist. The Patient Safety Recommendations patient claimed that the first orthopedist had used a defective knee component and had concealed the information. The first orthopedist refuted the allegation, stating that she had never received notice the knee component was defective and that she had used the device with a number of patients without problems or complaints. After the patient filed a lawsuit, the orthopedist learned from the manufacturer’s representative that one of the posts in the hardware had been found to be defective. Although the manufacturer had identified the post defect, it was not enough to warrant an FDA recall during this time period. In this case, the FDA did not consider that the device met the requirements for a class recall. However, had the physician known of the defect, disclosure to the patient should have occurred—an action that might have prevented the malpractice allegation. The FDA has mandated that manufacturers must include a unique device identifier (UDI) on all devices, starting with implantable devices. Implementation of the UDI system is expected to begin in 2014. UDIs can be captured in the EHR and used for device-

receiving, assessing, and acting on device recall information. ∙∙ Review and understand the recall information provided by the manufacturer before determining the next steps for the practice and affected patients. ∙∙ Have a process in place for notifying patients of medical device recalls. Follow FDA and manufacturer recommendations regarding actions to take, even if the action is monitoring only.

to review the website at specific intervals: www.fda.gov/safety/ recalls. ∙∙ Follow the established process for properly handling explanted devices. ∙∙ If the device is removed in a hospital setting, the hospital retains responsibility and will ordinarily store it and maintain custody or control. Direct patient requests for the device to the hospital risk manager. ∙∙ For Class I recalls, work with the surgical facility where the device was implanted to verify which patients have the device. Notify the patients immediately, and determine the appropriate course of action. ∙∙ For Class II or III recalls, it is appropriate to inform patients of their options.

∙∙ Involve the patient in an informed consent discussion that encompasses the possible complications and side effects of device implantation so he or she can understand the benefits, risks, and alternatives. ∙∙ Dictate in the postoperative report the type of implanted device and its serial number or UDI, and copy the post-op report to the office record. Note the UDI number on the patient’s card in the office record on the first post-op visit. ∙∙ Assign a specific individual in the practice the responsibility of

Not all devices recalled are defective, and patients may not incur health problems. Not all recalls require revision or explantation. Monitoring the device ∙∙ Obtain manufacturer guidance; may be the recommended option. The complete a clinical assessment; and patient’s safety must be the highest discuss treatment options, risks, priority, and care should be taken to benefits, and alternatives with the confirm device failure if revision surgery patient. or explantation is being contemplated. ∙∙ Document the date the notice was received, the source of the notice, the device or product name and model number, the names of patients in the practice who were notified, and actions taken. Monitor patient compliance with and response to the notification.

After reading the recall information, determine whether the patient must be seen and assessed and how quickly action must be taken. Depending on the category of the recall, the physician practice can be responsible for taking appropriate corrective action. The time frame for acting should be determined by the manufacturer’s recommendations ∙∙ Subscribe to the FDA recall web and the classification of the recall. service, and assign a staff member

National Nurses Week Continued from page 1

Menninger has concluded.”

night, they must be attentive to patients’ behaviors, reactions and emotions so At Menninger, Warnock works on that they can report back to the care the Hope Unit for adults with complex team and help facilitate adjustments psychiatric issues that have hindered to a patient’s personalized treatment their capacity to meet important approach to improve that patient’s vocational, personal and interpersonal quality of life. goals. Every patient works closely with an inter-professional team comprised “Everyone on the care team has a voice of psychiatrists, psychologists, social and plays a critical role in the wellworkers, mental health associates, being of the patient,” said Warnock. nurses, chemical dependency counselors “As psychiatric nurses, our role is to and other specialists. Since the nurses constantly evaluate how patients are spend time with patients both day and not only handling their illness; but May 2014

also how they are handling the stress Due to Menninger’s focus on treating of their illness.” highly complex psychiatric issues, many of Warnock’s patients have sought She adds that nurses in psychiatric treatment at two-three other mental environments have to be well-versed health facilities prior to Menninger. She in the latest psychiatric diagnostic notes that many of those patients have manual and evidence-based treatment a sense of hopelessness and helplessness approaches because, once the doctors because even they have stigma-filled leave for the day, it’s up to the nurses perceptions of mental illnesses and to underscore and reiterate what the treatment. patients have learned in treatment, especially when the patient is having As a top-ranked psychiatric hospital a rough day and is reluctant to leave with 60 percent of its patients coming his or her room.

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Houston Medical Times

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National Nurses Week Continued from page 18

from outside Texas, Warnock says Menninger differentiates itself from other psychiatric hospitals because it places an emphasis on educating patients and their family members about every diagnosis.

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“Education goes hand-in-hand with diminishing stigma and nurses are critical in helping patients and their families break down false perceptions of psychiatric illnesses and life after treatment,” said Warnock. “During the six to eight weeks that patients are here, our nurses are constantly working to instill hope in them, to reinforce the fact that their illness is not their fault and that, with proper treatment and development of cognitive behavior skills, they can be successful and productive. That’s what patients need to be reminded of to stay the course of treatment and that’s what family members need to know so that they can be supportive.”

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For Warnock, her commitment to diminishing stigma extends beyond the walls of The Menninger Clinic. Through her membership in the American Psychiatric Nurses Association and the National Alliance on Mental Illness (NAMI), Warnock immerses herself into the community to advocate on behalf of her patients with mental illnesses. Most recently, she participated in the NAMI of Greater Houston NAMI Walk with other nurses from Menninger as well as 15 patients.

“This was the fifth year that Marilyn participated in the local NAMI walk and it really shows her commitment to both her patients as well as her dedication to raising awareness about mental health treatment,” said Pam Greene, Ph.D., RN, chief nursing officer and senior vice president at Menninger. “As we like to say, her cando attitude rubs off on patients in a way that inspires transformative change. Warnock’s treatment perspective That’s why she has been recognized as stems from her experience of treating one of Menninger’s top nurses as well patients for both physical and mental as one of Houston’s top nurses.” illnesses. After beginning her career on the cardiac unit at a hospital in In 2012, War nock received Ohio, she later worked as an emergency Menninger’s highest nursing award, room nurse where many of the patients the Gary Napier Nurse Excellence she saw suffered from mental illnesses. in Direct Care Award, for being a That’s when she recognized that these patient advocate and fostering strong patients have the opportunity to relationships with patients, families and get better, but that it’s a continuous mental health organizations. She has also been nominated by the Houston learning process over time. Chronicle as one of the city’s top 100 “It’s no different from having a heart nurses. attack and taking blood medication,” Warnock said. “It’s an illness, like any “When patients e-mail us to tell us other illness. You need to get treated. that they’re doing well after treatment, There are a lot of patients who have a I’m reminded that I’m fortunate to work mental disorder and, after treatment, at such a great place like Menninger are very successful and have normal, that allows me to truly impact lives. That’s what’s truly rewarding for me,” full lives.” said Warnock.

Healthy Heart

Continued from page 3 remaining tables starting at $5,000. Tickets are available online at houstongored.heart.org or by phone (713) 610-5000. For more information, please contact Deandrea Dillard at (713) 610-5023 or deandrea.dillard@ heart.org. About t he A mer ic an Hear t Association

The American Heart Association is the nation’s oldest and largest voluntary health organization dedicated to building healthier lives free of cardiovascular diseases and stroke. Our mission is to build healthier lives by preventing, treating and defeating these diseases – America’s No. 1 and No. 4 killers. We fund cutting-edge research, conduct lifesaving public and see Healthy Heart page 21

May 2014

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Houston Medical Times

Page 21

Healthy Heart

Continued from page 20 professional educational programs, and advocate to protect public health. To learn more or join us in helping all Americans, call 1-800-AHA-USA1 or visit americanheart.org. About Go Red For Women®

Go Red For Women® is the American Hear t Associat ion’s national movement to end heart disease in women. We are committed to the fight, for as long as it takes. The American Heart Association’s Go Red For Women® movement advocates for more research and

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Health Survey

implications. The Texas Commission on Environmental Quality placed 10 local ZIP codes on its Air Pollutant Watch List (APWL), and this signals “particularly high levels of toxic pollutants along the Houston Ship Channel,” according to the report. Only 38 percent of respondents who lived in or adjacent to these locations reported their health as excellent or very good, compared with 57 percent of individuals living inside the 610 Loop and 50 percent living outside the 610 Loop. In addition, 54 percent of those living in the APWL areas said they were “very concerned” about the effects of air pollution on their family’s health,

Continued from page 4

compared to 43 percent of those living elsewhere in Harris County.

The study also found that “feeling comfortable in one’s neighborhood” can contribute to health. “The surveys show that people who live in places with high levels of social capital, interpersonal trust and a strong sense of belonging report better physical and mental health,” Klineberg said. “Conversely, living in neighborhoods with low levels of social cohesion and high degrees of alienation and social disorder is related to higher levels of anxiety and depression and to lower levels of self-rated health.”

The report noted that “despite Houston’s growing economy and low unemployment rates, the inequalities have only deepened in recent years.” More than one-fourth of all the survey participants said they had difficulty during the past year paying for groceries to feed their families. “Inadequate access to healthy, affordable food is clearly part of the reason why poverty and poor health are so strongly interconnected,” Klineberg said.

trail within a mile of their home, but 57 percent said that they had not visited any of Houston’s hike or bike trails during the past year.

The Survey Research Institute at the University of Houston’s Hobby Center for Public Policy conducted the telephone interviews for the Houston Area Health Survey between June 6 and July 17, 2012. The survey reached a representative sample of 1,200 Harris County residents, measuring their self-reported health In addition, the survey suggested status, their experience with Houston’s that many residents are failing to take health care delivery systems and the advantage of the available opportunities health-related characteristics of their for health-enhancing activities. For neighborhoods. example, 58 percent of Houstonians reported that there was a hike or bike

Legal Health

Continued from page 6 requests in order to give RACs time to complete all outstanding claim reviews and other processes by the end date of the current RAC contracts. CMS’ notice further set June 1, 2014 as the last day any RAC may send improper payment files for adjustment. This hiatus—expected to last at least six months, and potentially longer—may give providers needed breathing room from new RAC audits. This, in turn,

would allow the appeals backlog to shrink in size. OMHA’s actions to defer the assignment process appears contrary to the controlling Medicare statute which requires an ALJ to conduct and conclude a hearing “not later than the end of the 90-day period beginning on the date a request for hearing has

been timely filed.” OMHA’s decision to suspend assignment of appeals, even temporarily, plainly violates this language. Neither statute nor regulation makes an exception for interrupting the appeals process and, if challenged, it is possible that OMHA’s deferred assignment process may be arbitrary and capricious under the Administrative Procedures Act.

In the wake of the OMHA Forum, the biggest unanswered question by far, however, is whether CMS will be responsive to feedback regarding a need for significant improvements at the Redetermination and Reconsideration levels of appeal, the first two levels of the appeals process. Time will tell … stay tuned.

The Framework Continued from page 8

establishing a new observation unit, “We are excited about our growth and expanding the post-acute care unit and future,” Cordola said. “But I want to building out new inpatient beds and assure our patients and the community operating rooms. that Memorial Hermann-TMC will continue to meet their needs now “Through our partnership with without disruption as we prepare to The Master Plan builds upon the UTHealth Medical School as well as meet their needs in the future.” “Our buildings tell a remarkable tremendous growth at Memorial our private physicians, we have recruited story about our history, but it is our Hermann-TMC over the last year. In phenomenal clinicians, expanding the employees who truly define our legacy,” June 2013, the Board approved $50 services provided across our system,” said Craig Cordola, CEO of Memorial million to address short-term capacity Cordola said. Hermann-TMC. “With this expansion, projects at Memorial Hermann-TMC, TMC has set new standards of care in Texas and the nation through advances in the practice of medicine. The first building was only 200,000 square feet; today, the System’s flagship hospital spans more than 2.5 million square feet.

we are building towards our future and investing in our people. It gives me great pride to be a part of this seminal moment in our hospital and system’s history.”

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Houston Medical Times

High Tech Gadgets

HOUSTON

Continued from page 10

in their own well-being,” said Kimberly Berg, R.N., clinical manager. “Patients in this program enjoy greater peace of mind knowing the people responsible for their medical care have their latest heath information.”

number of physicians affiliated with Memorial Hermann, are already using Virtual Care Check to monitor patients who suffer from complex chronic diseases, as well as those discharged with specific diagnoses such as heart failure, heart attack, and pneumonia.

patients on a daily basis.”

Remote health care technology does not replace routine medical appointments; rather, it allows doctors to deliver higher quality, more personalized patient care, efficiently and cost effectively, anytime, “I feel like my old self again. Virtual anywhere. Virtual Care Check also “Memorial Hermann Home Care enables patients to take a more educated Care Check ensures I stay healthy without a whole lot of work,” said Weir. patients have demonstrated noteworthy and active role in their well-being and “I am living a better life because of this improvements in their medical conditions have peace of mind knowing their amazing technology from Memorial and a reduction in unscheduled clinic health care providers have up-to-date and emergency visits,” said Metzger. information every day in order to adjust Hermann.” “Virtual Care Check improves self-care, their medical care. Memorial Hermann health care treatment, and medication compliance by providers, in addition to a significant educating, motivating, and monitoring

Food Prescription Continued from page 12

or “swallow” these lipoprotein molecules and carry them to our cell walls. Excess buildup of lipoproteins in our blood vessel walls can contribute to abnormal blood vessel function.

mood disorders, insomnia, impotence, loss of libido, fatigue, attention deficit disorder, aches and pain from arthritis, and a generalized decrease in mobility. These common health conditions are often associated with many advanced disease states such as heart disease, cancer, In the early phases of coronary artery diabetes, and more. Unfortunately, many disease, arteries within the heart become of these diseases begin before the prime damaged due to the buildup of fatty of our lives. molecules and associated low levels of inflammation within the arterial walls. Essentially the consumption of fish, There is a need for revolutionary change chicken, pork, and beef contributes to in how we address chronic illnesses in coronary heart disease by increasing the this country and around the world. If amount of fatty molecules in the blood we continue in our current approach of and the blood vessel walls; and, more trying to find the next “magic bullet” pill, importantly, through the development of manipulate the next lethal gene, or design a chronic process of inflammation that the next high tech surgical procedure can have acute flare ups which are the while ignoring the obvious underlying underlying causes of heart attacks. cause of why we are ill, the problem will only persist. In this setting, we will pass True Health on a legacy of sickness and disease to future generations. If we were to closely evaluate our current national health condition we would find Our new paradigm will be one in which that our lives are progressively becoming we address chronic illnesses from the unraveled by our poor health. We perspective of our lifestyle behavior, with regularly suffer from headaches, allergies, optimal nutrition being the central theme. The major burden of chronic illnesses

on our collective health could be heavily reduced or nearly eliminated, by shifting focus to our new health care model. We should always strive to eat better, think more positively, exercise longer and more effectively. With a better understanding of human physiology and nutrition, we can create a healthy, disease-free society just by changing the way we eat. Baxter Montgomery, MD, is a cardiologist in Houston, TX and founder of Montgomery Heart and Wellness program. He is a Clinical Assistant Professor of Medicine in the Division of Cardiology at the University of Texas and a Fellow of the American College of Cardiology. Dr. Montgomery is the author of Food Prescription for Better Health and a member of the Physicians Committee for Responsible Medicine. He is a contributor to the newly released, Rethink Food: 100+ Doctors Can't be Wrong (www.rethinkfoodbook.com). For more information on Dr. Montgomery, visit http://www.drbaxtermontgomery. com/.

Blood Transfusions Continued from page 14

is just how practical it is. The materials he will use to build the device, like the saline solution, are already approved by the U.S. Food and Drug Administration. This significantly reduces the burden for regulatory approvals, which should help keep the cost of the system at around $50 and allow it to come to market sooner.

Shevkoplyas plans to create won’t require any significant changes to these practices. Instead, the small, disposable device would be placed between the blood bag and the patient during transfusion, completely at the discretion of the patient’s care team.

“We’re trying to fit as much of this technology as we can into the existing paradigm of transfusion. We want to empower medical professionals at the scene to make the decision about using this system,” Shevkoplyas said. “You cannot save people’s lives without blood transfusions. We’re just trying to make Together, these features make it much this life-saving procedure as safe as Additionally, health care systems more likely that Shevkoplyas’ device will possible.” worldwide already have invested billions move from the lab to clinical use, where of dollars into existing blood storage and it can have a positive impact on patient transfusion practices. Using the device health. May 2014

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