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12/09/2016

Tackling the Latest Challenges in Safe Blood Accessibility

Thirty years of work, sparked by the spread of HIV, has led to great improvements in blood safety and availability in developing countries, especially in sub-Saharan Africa. The World Health Organization reports that most, about 65 percent, of that new safe blood went to children under five years of age. Much of that blood also was used to save mothers during childbirth as bleeding is the leading cause of maternal deaths in developing countries. Read Full Post >

12/02/2016

What Does it Take to Get Their Attention?

This week, the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met to consider the RAND report on the sustainability of the blood supply. The committee made critical comments and recommendations to the Assistant Secretary for Health, whose office funded the report. ACBTSA established blood is explicitly seen as a public good and we hope rational policy decisions regarding the blood supply system will be forthcoming from the incoming administration. Read Full Post >

11/21/2016

Alphabet Soup: A-B-O Sustainability via ACBTSA, BPAC, and ASH

Last week has been key in setting future policy for sustainability of the U.S. blood supply. ABC President Susan Rossmann, MD; Chief Medical Officer Louis Katz, MD; and CEO Christine Zambricki, DNAP, CRNA, FAAN, represented ABC members at several regulatory meetings that could severely impact blood centers, donors, and the communities we serve. Read Full Post >

11/04/2016

Election Fatigue? Not at ABC!

Many people ask “what it is like to work in Washington D.C. in the midst of the election?” In reality, the Presidential election is a distant news story here. The frenzy of activity in the nation’s capital is fed by our work with members of Congress as well as ongoing communication with our regulatory partners at the Food and Drug Administration, Centers for Disease Control and Department of Health and Human Services. Read Full Post >

10/21/2016

ABC’s Focus on Member Education

A focus on continuing education is an important part of any organization’s success as studies show that an investment in your employee’s knowledge, skills and abilities has a direct correlation to their productivity and motivation. ABC has long recognized this through our webinars, meetings and workshops that bring together individuals from throughout the industry to share best practices and prepare for the future. Read Full Post >

10/14/2016

Digital Patchwork

Many of you may have heard the recent news on massive distributed denial of service attacks are being launched from unpatched security cameras connected to the Internet—but that is the just the tip of the iceberg. Hackers are targeting a number of unsecured devices now, which will make vulnerabilities and patch management not only a necessity but an artform. Read Full Post >

10/07/2016

HIV/MSM Docket Reopened

The authors of this piece participated in an evening long meeting last week to discuss the most appropriate respons-es to Food and Drug Administration’s (FDA) reopening of its docket on the HIV guidance. The meeting was attend-ed by ABC, Center for Biologics Evaluation and Research (CBER), leadership from FDA, American Medical Association (AMA), HIV clinicians and prominent advocates on behalf of men having sex with men (MSM), all of whom recognized the stigma attached to the continued time-based MSM deferral. The single issue was how (not whether) to move forward on policy adjustments in response to the long controversy around this the deferral. The current one-year deferral is based on sexual identity, as opposed to specific behaviors associated with increased risks for HIV infection. Individual risk assessments are being used elsewhere, but the personnel and environments are completely different than ours. Read Full Post >

09/23/2016

Zika: A 20,000 Foot View

As Zika funding remains an uphill battle on Capitol Hill, ABC remains steadfast in our advocacy efforts. We con-tinue to work toward an opportunity for a line item funding Zika testing at blood centers, an option that may be the best for long-term sustainability of appropriation. Read Full Post >

09/16/2016

When Zika Gets Political, Everyone Loses

Congress returned to work on September 6 for its last legislative session before the November presidential election. They return following seven weeks of congressional recess. Their return also comes nine months after the first case of Zika in Puerto Rico was reported and nearly two months following the emergence of the first locally-transmitted case of Zika in the continental U.S. After five days of arriving in D.C., Congress has already begun discussions of when they would leave again—possibly as early as next week. And through all this time we remain no closer to seeing a Zika-funding package. Read Full Post >

09/02/2016

All Zika, All the Time II

Good News: The new Zika guidance is as clear as can be. Bad News: Universal ID-NAT is a titanic operational effort—unclear it can be finished on the FDA’s schedule. Good News: A universal mandate becomes a pass through that attenuates concerns about its cost—the end user (hospitals) will (appropriately) bear it. Bad News: Might the $100 million* we will consume in the next year be put to better use, e.g., mosquito control? Many of us are asking if this is the best use of public health resources. Read Full Post >

08/12/2016

A Hand Up or Handout?

Zika virus causes grave concern among public health officials where mosquito-borne transmission is possible. Beyond the risk the virus represents to fetal central nervous system (CNS) development, it might wreak havoc on the developing CNS throughout its developmental period—many years. Read Full Post >

07/29/2016

Oy Vey!

Some blood centers are testing for Zika viral RNA using investigational new drug (IND) protocols cleared by the Food and Drug Administration (FDA) and more will soon or are considering doing so. FDA has required that test-negative blood components be labeled “negative for Zika virus by an investigational test”. The FDA also recommends that an appropriate “acknowledgment” or consent be obtained prior to transfusion of high-risk recipients via a labeling supplement or modification of the circular of information. Here is language accepted by FDA for one IND participant. For “areas of active transmission or donations collected from individuals with known risk factors, it is recommended that an appropriate acknowledgment or consent be obtained prior to trans-fusion of a high risk recipient, e.g., a fetus in utero or pregnant woman.” You can imagine that this is causing some consternation at centers and hospitals. Dr. Susan Stramer at the American Red Cross and I are fielding urgent inquiries from our clinical friends asking what they should be doing (and why). Read Full Post >

07/22/2016

Emerging Medical Countermeasures

Along with the challenges that new waves of pathogens may cause, modern humans are quite good at producing complicated messes and then needing to apply our resources and innovation, reacting to what we’ve brought about. I ponder this after researching an acronym I learned from recent ABC and BCA announcements—BARDA (Bio-medical Advanced Research and Development Authority). Read Full Post >

07/15/2016

Bench Strength On the Shelf

Recent events around the world underscore the need for continued preparedness and vigilance for blood centers. The attack in Nice, France, on July 14, follows a series of deadly attacks in the U.S. and abroad over the past few years, all of which seem to be escalating in recent months. Read Full Post >

07/08/2016

How Can Our Association Work Best For Our Members?

As we head west to the Hawaiian Islands for the Summer Meeting, this issue has come to prominence. In theory and bylaws, we are an association of independent blood centers who serve our communities. In practice, more and more blood centers are part of a larger group. There are the affiliations and unions at the governance level (BSI, Versiti, ITxM, etc.). These affect ABC membership directly, and at the Annual Meeting we dealt with this issue through bylaws changes. But there are also purchasing groups, blood supplier groups, at least one insurance group, and other affiliations. ABC’s relations with them are varied, and changing. Most of these relations are infor-mal, coming from overlaps of memberships. We are always interested to hear what our members want to say, in whatever forum. Read Full Post >

07/03/2016

Are You Taking Advantage of the Continuing Education Credit Opportunities through America’s Blood Centers Professional Institute?

America’s Blood Centers Professional Institute (API) offers many ways to earn continuing education credits throughout the year. Whether the course is a webinar, a face-to-face workshop, a session in our annual or summer meetings, or an upcoming eLearning course, many of our courses are eligible for continuing education credits. Read Full Post >

07/01/2016

Got Blood?

Summers are always tough for blood centers, but it looks like this one will be worse than usual. Multiple hits on the donor base (enumerated in last week’s Newsletter) have converged in what one center CEO called a “black swan” and “perfect storm” in the SAME sentence. We will respond by rounding up the “usual suspects” to get through until Labor Day: public appeals, appeals to established and lapsed donors, special blood drives, badgering our hospitals about judicious transfusion, rotating inventory to sites of greatest need, importing when possibleet al. All that said, a big slice of the problem is that we run our business like my father ran his butcher shop in the 1950s. Izzy got his beef from the wholesaler “just in time,” and consequently the ground beef in the display case was always bright red—nothing was old enough to turn brown—so nothing had to be pitched (i.e., outdated in our argot). Problem was that if a big customer needed a couple hundred pounds on Friday for a party on Saturday, the inventory was short. We in the blood community, as a business strategy to protect margins, have abandoned the inventory cushion that is critical for responding to sudden need. What was reasonable in an Iowa meat market in 1950 has troublesome implications for a blood system. Read Full Post >

06/24/2016

Dot The Is and Cross Your Ts

I participated in a training session on table-top exercises yesterday. It was basic training, but still very informative. The first lesson was that you have to set the ground rules and Rule Number One is that participants can’t challenge the scenario. You know, complain that a scenario wouldn’t possibly happen. As the instructor discussed the key points of scenarios and inputs, he stressed making them believable, no zombie invaders or blizzards in Southern California. Certainly a mass shooting a few blocks from a blood collection center would be believable, as would an overwhelming response by hundreds if not thousands of donors following the shooting. Set the scenario during the summer when the inventory historically dips, and while plausible, the exercise participants are beginning to squint at you. Next input, a massive international media response. But what about an exercise input that the blood bags you use are now under recall? Holy smokes, the participants are beginning to hate the designer of the exercise. They start complaining that that would never happen. You remind them of Rule Numero Uno. Read Full Post >

06/17/2016

Some Thoughts About Orlando

OneBlood in Orlando, ABC members from Florida to Hawaii and from Texas to Alaska extend condolences to all touched by the horror of the attack at Pulse last Sunday. We owe thanks to the blood donors whose willingness to extend their arms before, during, and after these events saved and will continue to support the lives of the victims. These words are a faint reflection of what is in our hearts, but if the survivors and their families and friends can know that it’s from our hearts that we speak, that will be enough. Read Full Post >

06/10/2016

Not Just Another Survey

For over a decade, ABC has conducted three essential annual surveys to provide significant member benefit. The first of these, the ABC Executive Compensation Survey, arrived in mailboxes on Wednesday. With a participation rate of 95 percent last year, this survey is used to satisfy the Form 990 requirement to supply information about how a CEO salary is determined. Many members provide the results to their board to support compensation policies commensurate with the marketplace. Read Full Post >

05/27/2016

Looking hard for something that is not Zika to opine about!

Generally tired of talking about Zika, so I thought I would recommend a recent read to those in our audience who shrink from reading anything about statistics. The tome is titled,The Seven Pillars of Statistical Wisdom,by Stephen Stigler, the Ernest DeWitt Burton Distinguished Service Professor in the Department of Statistics at the University of Chicago. He asks "What is statistics?" Then, in language accessible to a lay audience, sets out to distinguish statistics from math and provide an account of the discipline's history and to "articulate the central intellectual core of statistical reasoning." The historical context that pervades the book is a particular delight and adds a layer of pragmatism that was often missing in my course work. Read Full Post >

05/20/2016

A Day To Remember

Monday, May 23, will be a red letter day for most of us who work in blood centers. After years of effort, revisions to federal regulations for the collection of blood will become effective. The work involved with determining and implementing these changes has been massive, even without the distraction of Zika. A proposed rule was published on November 8, 2007, and the Food and Drug Administration (FDA) just published the final rule on May 22, 2015. The rules modernize the approach to regulation of infectious disease testing and make new provisions for donor selection. Read Full Post >

05/13/2016

The Re-Birth of FABC

Pressed by fundamental changes in our industry, ABC conducted a strategic planning exercise two years ago and developed a clear definition of its priorities, including education, and brought renewed energy to our association. Soon, the need for a larger vision and relevance spread to the Foundation, which made supporting the ABC Professional Institute (API) the theme of its fundraising campaign. Read Full Post >

04/29/2016

The Future Blood Industry Will Lag Behind, Not So

Recently, a thought-provoking commentary on the “Evolution of the nation’s blood supply system” appeared inTransfusiononline, ahead of print. The authors predict our current network of independent and American Red Cross blood centers will evolve to either a “consolidated“ system of four to six independent suppliers or a single national system. Disturbingly, the authors predict a period of “temporary localized disruption of services” as we move to the new format, with shortages of certain products and a lack of full support for patients needing specialized products. Read Full Post >

04/15/2016

Opportunity is Knocking – Prepare for the Future before It’s Too Late!

Is your medical director threatening to retire? He or she doesn’t care about finance or human resources? Tired of worrying about where we will find the next generation of medical leadership at blood centers? Docs, are you looking for a skill set to advance your career in blood banking? Have I got a deal for you! Rachelle Fondaw, director of Education and Grants at ABC, is collaborating with an international cast of education professionals from the Alliance of Blood Operators (ABO) to author a (largely) web-based Medical Leadership Program to support the development of (our) future medical leaders. The project has grown out of a preparatory research initiative commissioned by ABO outlining the leadership competencies needed by a successful chief medical officer. This program can accommodate only 25 delegates from ABO members, so you need to get in on the ground floor. Read Full Post >

04/08/2016

Do Something Amazing in August with the Missing Type Campaign

ABC has joined more than 24 blood services across 22 countries for an incredible global event, the “Missing Type Campaign.” Through this international collaboration, ABC members have the opportunity to unite globally to build the largest donor recruitment and awareness campaign ever! A role exists for both ABC and its member blood centers in the Missing Type Campaign. ABC’s portion of this initiative involves contacting large national or international sponsors and iconic settings (e.g. think Route 66). Member blood centers should begin preparing now for the week of August 15-21 by asking your local corporate brands, organizations, and community influencers to remove the letters “A,” “B,” and “O” from their websites, social media logos, and signage without explanation beginning August 15th. The media will reveal that the mysterious removal of the aforementioned letters represents the need for new blood donors. Read Full Post >

02/26/2016

All Zika, All the Time

There is a scary aspect to protecting blood safety being brought into bright relief by expanding Zika epidemics in the Americas. We have generally considered sustainability of the blood supply over the medium- and long-terms in the context of the commoditization of blood, unrestrained competition, and declining margins, but Zika raises more acute concerns. The recent Food and Drug Administration guidance and its impact on the blood community in Puerto Rico are instructive, esp. after talking to colleagues there. A quick read of the guidance tells us that the agency expects cessation of collections on the island by March 1 unless certain conditions are met; conditions that likely cannot be on that timeline. The expectation then, absent enforcement discretion, is that the island will import components from the mainland to cover need. I have no doubt the blood community will respond in the short run, regardless of financial considerations, because that is our mission. However, if Puerto Rico stands down for several weeks or months, where will the people now employed to collect, process, and distribute blood get their paychecks? After they have moved on to other jobs to support their families, how will their capacity be reconstituted when the crisis passes? Read Full Post >

02/12/2016

Five Reasons to Vote

With the presidential election occupying every minute of media time and the collective angst of voters about what what’s wrong with Washington, it may be tempting to think that your vote will not make a difference. While voting for your elected officials is a vital social responsibility, there is one other place where your vote really counts, and that is America’s Blood Centers. Read Full Post >

02/05/2016

A Prescription for Erythrogizer

Red blood cells (RBCs) may well be the Rodney Dangerfield of pharmaceuticals because they seem to get no respect. In fact, two major thrusts in transfusion medicine, patient blood management, and hemovigilance, tend to accentuate negative aspects of transfusion care with inherent messages that blood is very risky and needs to be either avoided altogether or, if given, closely scrutinized. Seldom is heard the encouraging insiders’ word that RBCs are a miracle drug, which in various situations can save your life, provide you comfort, give you energy, sharpen your thinking, and even improve your appearance. Unfortunately, given the current cost-saving pressures in healthcare, such undervaluation may be causing episodes of under-transfusion that adversely affect quality of life for patients and their caregivers. Read Full Post >

01/29/2016

Advocating for Advocacy

Advocacy is one of ABC’s central priorities – we know that it is one of the most highly valued services of ABC’s activities. We have excellent but limited resources, so we must be focused. At ABC’s board retreat this week, we determined four priorities to address this year, chosen based on the SEQuaLS member satisfaction survey results and the likelihood of success. Read Full Post >

01/22/2016

Whither Zika Virus?

ABC posted talking points about Zika virus to the Member Website last week. That was in the context of this Flavivirus spreading from its “home” in Africa eastward, with extensive epidemics in South and Central America and the Caribbean Islands (see Fauci AS, Morens DM). Driving immediate concern is a temporal and geographic association of Zika activity with the increased incidence of a devastating neurodevelopmental abnormality, microcephaly, especially in Brazil. The hypothesis is that in utero Zika infection is responsible. CDC has issued a warning for pregnant U.S. women going to affected countries (see CDC’s Interim Guidance). Read Full Post >

01/15/2016

Recovered Plasma and New MSM Deferral Guidelines

The Food and Drug Administration’s (FDA) long awaited final guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” was is-sued in December. The permanent deferral of men who have a history of sex with other men since 1977 (MSM) has been eliminated and otherwise qualified donors with a history of MSM who have had no such sexual contact in the last 12 months are eligible to donate blood. What may appear to be a straightforward decision to implement revised donation procedures to accommodate the guidance is complicated by recovered plasma (RP). Read Full Post >

01/08/2016

We Love You, We Love Our Mission, We Want You to Become Part of Us

Sound familiar? For most organizations contemplating partnership opportunities, mergers, or acquisitions, this sentiment serves as a foundation for considering opportunities with a trusted partner. Read Full Post >

12/18/2015

As The Year Draws Nigh

As the end of 2015 draws nigh, I decided to clean house and accomplish my “ABC 2015 To-Do List” to clear the way for 2016 New Year’s resolutions. I am sharing this list with you today in the hopes that you will find it in your heart to review these items and pitch in to lay the groundwork for an even better, stronger ABC. Read Full Post >

12/11/2015

Just When You Thought it Was Safe to go Back in the Water

It is time once again for the Department of Health and Human Services’ (HHS) National Blood Collection and Utilization Survey (NBCUS), conducted by the Centers for Disease Control and Prevention (CDC). I know it seems like only yesterday (actually last winter) that you participated, but the latest data available on these things is from 2013. Preliminary results of the 2013 NBCUS were presented at this year’s AABB Annual Meeting in Anaheim, Calif., and CDC will aim to publish the results by early 2016. The survey results are used to generate national estimates of blood collections and transfusions to understand current blood use and to project future blood needs. Amongst the Feds, the data accumulated is of particular use to the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Health Resources and Services Ad-ministration, and the National Institutes of Health – in addition to HHS/CDC. For the blood community, the data are critical in our advocacy efforts. Read Full Post >

12/07/2015

Thoughts on This Season

This traditional holiday season of peace, love, and joy has been shattered by senseless acts of in-comprehensible violence. The mass shootings last week in Colorado Springs, Colo. and San Bernardino, Calif., as well as the earlier horror in Paris, Mali, Turkey and others remind us of the dark side of the human experience. Such aberrant behavior is so repugnant as to defy description. Yet with each horrible event, the positive side of human behavior comes forward. As one of our blood center colleagues Joe Chaffin, MD, at LifeStream in San Bernardino, located a mere half-mile from the scene of the shooting, recently wrote in a communication to ABC members: Read Full Post >

11/20/2015

Expecting the Unexpected

Last week, the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA), which reports to the Undersecretary for Health of the Department of Health and Human Services, met to discuss the sustainability of the U.S. blood supply. Among the concerns was the worry that a shrinking blood inventory and collection system, appropriate to the reduced level of routine red cell blood use, would not be able to provide appropriate surge capacity. Read Full Post >

11/13/2015

Veterans Paved the Way for Our Modern Blood Banks

On today of all days, as I write this column on Veteran’s Day, I am reminded of the enormous im-pact our veterans have made on this country. They put their lives on the line so that we may enjoy our freedoms and way of life. As members of the blood banking community we also realize that veterans paved the way for modern transfusion technologies. During World Wars I and II the critical need for blood on the battlefield progressed transfusion techniques and allowed for the organization of the blood banks we know today. Read Full Post >

11/06/2015

What are the Realities to Consider as We Think About Implementing Pathogen Reduction of Platelets in the U.S.? (1)

The transfusion medicine community welcomes approval of Cerus’s Intercept Blood System for pathogen-reduced (PR) platelets. It is an important safety step that will nearly eliminate bacterial contamination episodes, and be particularly valuable if paired with decreased testing, increased shelf-time, and the elimination of product irradiation. It is a first step to future PR systems that will be easier to use. Read Full Post >

10/23/2015

Where We’ve Been and Where We’re Going – The ABC Professional Institute

It is amazing how quickly a calendar year flies by. Here we are almost at the end of October and preparations for the holidays and end of the year have already begun. It is also hard to believe that just a year ago at this time is when we started planning the first stages of the ABC Professional Institute (API) – a one-stop-shop for all of ABC’s educational offerings. Reflecting on that first year of bringing the API from a concept to a tangible item, it is exciting to look back on what has been accomplished: Read Full Post >

10/16/2015

One Week: Two Communities, Two Tragedies

It is often said that families are “connected by blood.” Communities are too. On Sept. 24, a Ride the Ducks tour vehicle in Seattle collided with a charter bus going over the Aurora Bridge carrying students, resulting in five fatalities, 11 patients with serious injuries, and more than 20 others admitted to eight area hospitals. One week later, 350 miles away, shootings at Umpqua Community College in Roseburg, Ore. resulted in 10 deaths, with nine others hospitalized in critical condition. Read Full Post >

10/09/2015

Farewell

I can’t believe it has been over 13 years since I joined this wonderful association. What started as a temporary “stint” subbing for a membership manager who was going to be on maternity leave, blossomed into a fulfilling career, filled with professional growth and opportunities to learn and work with talented colleagues, and committed members and blood banking professionals in the U.S. and abroad. Read Full Post >

10/02/2015

Let’s Put Our Money Where Our Mouths Are

A persistently important issue mentioned when ABC staff discusses advocacy with the members has been the quality control (QC) burden associated with labeling and distributing leukoreduced (LR) apheresis platelets. FDA has determined that we must demonstrate statistically, with validation and QC testing, that our processes attain and maintain 95 percent confidence that 95 percent of our units contain <5 x 106 residual white blood cells (WBCs). This level of performance is clinically appropriate in my clinician’s brain (spare me the epithets please). If we believe that LR is clinically important, we should be stringent about what we distribute. The problem comes when the QC burden is greater than the QC benefit. Many of us think that with our robust plateletpheresis platforms and processes, we are well past that threshold. Read Full Post >