Onward and Upward—Journey to the Cloud

Cloud computing is bringing us closer to the utility information technology (IT) model: functionality on-demand, elasticity to increase or decrease resources as needed, and accessibility—the ability to access it from connected devices in any location. Deployment models can be private (services from internal hardware), public (services from a public provider), or a hybrid (services delivered by a combination of both). Service delivery models include Infra-structure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS), each with unique characteristics chosen for your needs. In simple terms, IaaS refers to getting your IT infrastructure needs for computing, storage, and networking from external providers, while PaaS is providing a software platform for developing custom software applications. SaaS refers to obtaining completely developed software application(s) from providers. Read Full Post >


Follow the Data

At the recent Blood Products Advisory Committee (BPAC) meeting (ABC Newsletter #42), the U.S. Food and Drug Administration (FDA) heard the committee’s endorsement for moving from the current universal individual dona-tion nucleic acid testing (ID-NAT) for Zika virus (ZIKV) to a model used for West Nile Virus (WNV) donor screen-ing—screening using minipools (MP-NAT) to reduce operational burdens, with rapid conversion to ID-NAT based on prospectively determined “triggers” that demonstrate at the probability of local (autochthonous) vector-borne transmission(s). This strategy was recommended by ABC via a statement endorsed by the Scientific, Medical, and Technical Committee, reviewed by the ABC Board of Directors, and delivered as a joint statement from ABC, the American Red Cross, and the AABB. The current expectation for WNV is that ID-NAT triggering will occur in an appropriate geographic region based on a donor’s residential zip code within 24 hours or less of reaching a trigger—a fixed number of presumptively viremic donors (and/or the presence of other WNV activity in the area served by a collection facility). For WNV, accomplishing this rapid conversion to ID from MP-NAT required the evolution of an effective communication system among laboratories and center-to-center that includes blast e-mail communications to formally maintained address lists and entry of appropriate data on a website hosted by the AABB. A similar website was established to accommodate information on ZIKV testing of donors during IND testing and remains operable. Such data entry and e-mail messaging must occur as soon as possible (again, not to exceed 24 hours) since other collectors must assess their need to transition to ID-NAT. Read Full Post >


A Bridge Too Far

The Trump administration would forbid using the terms “vulnerable,” “entitlement,” “diversity,” “transgender,” “fetus,” “evidence-based,” and “science-based” in 2018 budget documents from the Centers for Disease Control and Prevention (CDC). The original story is here. This is not the first attempt to muzzle an agency, but it is the first affecting one with which the blood community works very closely. Read Full Post >


BPAC Outcomes

Last week, the U.S. Food and Drug Administration’s (FDA) Blood Products Advisory Committee (BPAC) met for two full days of sausage making—not always pretty, but the committee came up with a tasty product. Two topics were of particular interest to ABC member blood centers. Bacterial contamination of platelets was the subject of draft guidances from the agency in December 2014 and again in March 2016. ABC commented repeatedly on these, last in late winter of this year to urge FDA to make available an approach like that used in the United Kingdom, Héma-Québec and most recently Canadian Blood Services. It is delayed, high volume primary culture, in return for 7-day platelet dating without secondary bacterial testing on day 4 and later during storage. If the FDA accepts the recommendation of the BPAC (it is not required to do so), we can deliver to hospitals a safe, ready-to-use platelet that requires no further testing and/or relabeling there. Ex-tended dating will be associated with lower outdates and offer operational advantages in collection facilities that will offset at least part of the increased cost of enhanced sensitivity. Consider this a victory for safety, customer service, and blood center operations—win-win-win. If pathogen reduction is the most effective approach to bacterial safety in platelets, then we now have a rest stop on the road to that approach while manufacturers make the process(es) more “user friendly.” Read Full Post >


Harvey & Irma Silver Lining: the HERF

The recent hurricanes more than earned their status as disasters from the despair, death, and destruction they left in their wakes. For us blood bankers the successful launch of an industry-wide, grassroots relief program has, at least, proven to be a positive outcome. The Hurricane Emergency Relief Fund (HERF), launched August 31st by Blood Centers of America, Inc. (BCA) using online giving tools and tracking supplied by Global Blood Fund (GBF), raised $27,571 over the subsequent six weeks. ABC, BCA, Cerus Corp., and a half dozen blood centers deserve special recognition for actively promoting this campaign. Read Full Post >


Introducing the ABC Public Policy Council

The newly appointed ABC Board of Directors held its first day-long meeting in Chicago on October 18th. As part of ABC’s re-alignment, the Board has affirmed building a unified advocacy presence for the membership as the central focus of ABC. This will be supported by scientific, medical, technical, quality, and regulatory strength. In doing so, the Board approved several changes to our internal advocacy structure to help drive member engagement, discussion, and ultimately consensus. Read Full Post >


Are RFPs Still Important?

At the recent ABC Financial Management & Information Technology Workshops, ABC members discussed working on projects to implement or upgrade their software applications, ranging from typical upgrades to complex system conversions and implementation of new systems. These discussions caused me to contemplate the relevance of the request for proposal (RFP) process and if it is still critical to project execution. Read Full Post >


The Power of Our Collective Strength and Commonality

With the 2017 ABC Financial Management Workshop wrapped up, we can reflect on what an exciting time it was! Houston is such a wonderful and vibrant city and even on the heels of Hurricane Harvey, you could feel the pulse of the city, whose residents won’t be deterred from their recovery. Through attending, we were able to assist in some small way by adding dollars to their economy. For that, we are grateful. Read Full Post >


Mother Nature Is No Match for the Force of the Blood Community

Hurricanes Harvey, Irma, and Maria left their mark, but so did blood centers around the nation. Proving once again their resilience and resolve to ensure blood is available when and where it is needed, no matter the circumstances. Read Full Post >


Challenges: A (not so) Unique Conundrum

I think each of us in our chosen industries believes the challenges we face are new and unique, until we are presented with the opportunity to join our peers in industry groups, which yields exceeding comfort to know our colleagues are often facing similar issues. The ABC Information Technology (IT) Workshop remains an industry-based meeting I make a point of never missing. This workshops never disappoints! Read Full Post >


Be a Part of the Solution

In March 2017, over 90 global experts in blood safety and development from blood centers, industry, government, and international non-governmental organizations (NGOs) gathered in Arlington, Virginia for the Third International Blood Safety Forum, co-sponsored by America’s Blood Centers and Global Healing. The meeting explored ways to increase access to affordable, safe blood for low- and lower-middle income countries (LMIC) in an era when fund-ing from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund has been redirected from preventing the spread of HIV to diagnosing and treating the estimated 25 million people living with HIV in LMIC. Accessible safe blood is an unfortunate casualty of this shift. Read Full Post >


If You Are Reading This…

…it means that, despite two major hurricanes in the past three weeks, ABC members assembled a quorum in Atlanta for a special members meeting and passed the bylaws changes needed to achieve the important realignment of ABC, Blood Centers of America (BCA), and HemeXcel. Despite logistical hurdles, 49 of 52 ABC members registered their votes, and an overwhelming majority of 97 percent supported the bylaws changes. Our thoughts and support go to the ABC centers and their staffs in Florida and Texas who endured the storms and now must manage their recovery. Their tasks make ours look a bit pedestrian. Read Full Post >


Don’t Wait, Plan Ahead For Disasters

September is National Preparedness Month and this year’s theme is “Disasters Don’t Plan Ahead, You Can.” Before I had even sat down to write this “Our Space,” we were slapped in the face by Hurricane Harvey and following closely is Hurricane Irma. Neither were your typical run of the mill hurricanes. While Harvey wasn’t the biggest hurricane in history, the fact that it sat right over Houston and dumped trillions of gallons of water in the same area made it unprecedented. Irma is huge and powerful from the get go, a “monster storm.” Read Full Post >


Every Dark Cloud Has a Silver Lining

The choice of topic for this “Our Space” was without question. The storm’s impact across the Gulf Coast has been heart-wrenching. The rain has stopped and flood waters are receding, but we don’t yet know what the aftermath of Hurricane Harvey will fully be. Read Full Post >


Build It and They Will Come

Perhaps I’ve been watching a bit too much of the Little League World Series, or perhaps I’m day-dreaming of being on a farm in Iowa instead of in the throes of Capitol Hill, but the movie “Field of Dreams” recently came to mind in relation to our legislative and regulatory advocacy efforts. Before I soil an iconic movie with the taint of our current political environment, I will preface the rest of my article with the caveat that what originally drew me to politics, and keeps me loving it to this day, is the founding principle that citizen advocacy is not only a right, but a responsibility, and any individual can make a difference. Read Full Post >


Who Saved a Life? You Saved a Life!

“If you don’t pat yourself on the back, no one will.” I cannot find a record of whose quote that is, but I think there is definitely validity to this statement. Lately, I have wondered why we as blood bankers have not tooted our own horns. Why have we not congratulated or celebrated the millions of lives we saved last year? Read Full Post >


Business is Business

Creative Testing Solutions (CTS), the American Red Cross (ARC), and OneBlood have announced the consolida-tion of their donor testing services into CTS. If my eyeball is accurate, that will concentrate 75 percent of the U.S donor testing volume with a single supplier. The size of the “new” company offers the prospect of economies of scale, not just on prices, but perhaps as leverage with test builders and maybe even with the regulator. No doubt this is a good business decision by the principals of the three organizations. Time will pass and we will understand the impacts. Read Full Post >


Strengthen Your Cybersecurity Information-Sharing

Cybersecurity is again in the headlines as a result of the most recent global-spanning cyberattack named Petya and its multiple variants. This was not a typical ransomware attack, but disguised to hide its true purpose of data destruction—hence referred to as wiperware. The attack utilized sophisticated techniques to spread built-in system tools to gain credentials. After gaining users credentials, the wiperware targeted other network devices to spread and encrypt them, making them unusable. There was a unique delivery mechanism used for delivery which included infecting an accounting company’s update servers to allow rapid propagation to its clients. There are multiple lessons learned here, including improving patch management, having a good backup and retention program, securing and locking down network devices, and controlling access privileges to built-in tools. Read Full Post >


The Data Conundrum

Chair of the Advisory Committee on Blood and Tissue Safety and Availability, Dr. Jay Menitove’s editorial in this month’s Transfusion Supplement is a must read for all of us in the blood community. While highlighting blood collection and utilization trend lines that are disconcerting, he more importantly points to the 2 year delay in having these data as our greatest weakness. Dr. Menitove notes that while the “NBCUS (National Blood Collection and Utilization Survey) reports are a great start, we need timely data more than ever.” Read Full Post >


Education Investment—Keep it on the Table and Make it Count!

Whether you watched proudly as a loved-one graduated or you participated in a conference, workshop, or other training program, education has been front and center in our lives over the past two months. When we reflect on education in the workplace, we tend to weigh the tangible and intangible reasons to invest in employee growth and education. Last week in Omaha, Neb., 81 attendees from ABC member centers participated in the very successful ABC Technical and Quality (TD/QA) Workshop. Read Full Post >


World Blood Donor Day

World Blood Donor Day, sponsored by the World Health Organization (WHO), is just around the corner on June 14. This year’s theme focuses on blood donations for emergencies. If you’re reading this column then you are well aware the blood that is available for emergent situations and after tragic events is the blood that was already on the shelf at the hospital or blood center, collected and processed days earlier. In fact, recently after the tragic incidents in Manchester, U.K., an official from the NHS Blood and Transplant system implored the thousands of people reading The Guardian who wanted to help should become “regular” blood donors so the country could “make sure we are again ready for any major incident.” One of the stated objectives of World Blood Donor Day is “to build wider public awareness of the need for committed, year-round blood donation, in order to maintain adequate supplies”. While this is indeed something that we all are in alignment with, what is not clear is how we get there. Maybe it’s time to change the conversation. As individual blood centers we try to break through the bombardment of marketing messages donors take in on World Blood Donor Day, but how do we continue with that conversation all year long? How do we leverage the power of our collective efforts through ABC to create the awareness and sense of urgency that turns episodic blood donors into regular blood donors? Read Full Post >


Formulating Solutions

Not a week goes by that I don’t sit in a congressional office, educating a staff member on the need to address the sustainability of the blood supply and associated issues that impact the daily operations of ABC member blood centers. We discuss both near- and long-term topics, and then hit an inevitable question – “What do you want us to do about it?” Read Full Post >


One CEO’s Thoughts on the Prospect of Federal Tort Reform

The topic of “tort reform” has been around for quite some time. It has been primarily a state issue. States have ad-dressed this in varying degrees. For full disclosure, I have been involved in the tort reform effort in Mississippi for more than 15 years. At that time, states like West Virginia, Illinois, Louisiana, California, and yes, Mississippi, were considered fertile ground for lawsuits, because certain jurisdictions were considered “friendly” to the personal injury bar. Because of efforts from both the medical and business communities, frivolous and unfounded lawsuits have diminished significantly in Mississippi. Read Full Post >


Ransomware that Makes Everybody Wanna Cry

Most of you are already inundated with information about this newest form of ransomware that has caused massive impact in healthcare and other operations in 150+ countries. But the purpose of this article is to highlight the importance of setting up a cybersecurity program and a plan to protect your organization and data so you are much better prepared for sophisticated attacks in future. Read Full Post >


Sudden Change is Not the Enemy

We would like to thank Christine Zambricki for her service to ABC members in support of their lifesaving mission— guaranteeing a safe and adequate blood supply is our bone marrow. Everyone needs to keep positive thoughts for favorable outcomes as she attends to important duties at home. Read Full Post >


Progress report—a PR update (pathogen reduction, not public relations)

I went to a meeting last week and became focused on the progress underway signaling more options for broad implementation of PR in blood centers. After decades of reading papers and listening to abstracts at conferences, real movement toward reducing known emerging and future infectious risks from transfused blood may be measurable in months to years, not years and years and years. At the risk of being a jinx, it’s a good time to celebrate that. Read Full Post >


The Perfect Can Be the Enemy of the Good

At the recent International Blood Safety Forum, many of the global representatives reflected on the challenge of building a voluntary, non-remunerated base of blood donors to sustain a safe blood supply. In my work, I have seen a spectrum of high index nations, and low- and middle-income countries (LMIC), grapple with this issue; yet it is particularly problematic in LMICs. In Sub-Saharan Africa alone, there is an estimated 40 million unit shortfall in the supply of blood annually. Read Full Post >


Plus Signs

Some positive next steps are afoot in Washington after the RAND study’s release. The partner efforts of ABC, Department of Health and Human Services (HHS), and others to promote the sus-tainability of the blood supply and build on the initial work of the RAND study in exploring alternatives in policy and reimbursement is setting wheels in motion here in the Capital. We recently learned the Depart-ment of Health and Human Services (HHS) is planning multi-agency efforts to conduct stress testing in the areas of blood center donor testing, economic feasibility, and surge capacity. Agencies involved in these efforts include the HHS Office of HIV/AIDS and Infectious Disease Policy, Food and Drug Administration (FDA), HHS Office of the Secretary for Planning and Evaluation (ASPE), and the Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response. Work will begin in these agencies as soon as next month. We have also learned that an internal briefing with the newly appointed acting HHS Assistant Secretary for Health Don Wright, MD, MPH, is scheduled in the coming weeks to discuss the current state of the blood supply and actions needed to ensure its viability. Read Full Post >


Dear Colleagues,

The 55th ABC Annual Meeting is now behind us. The good feelings generated by another successful fundraising year for the Foundation for America’s Blood Centers (FABC) and superb events are giving space to the realization that we have to do it all over again. Our priorities, in support of ABC’s strategic agenda, are clear: get value from the Data Warehouse, establish a solid advocacy platform with the new administration, and continue to educate our community. Read Full Post >


A Point of View

I made a few brief comments at the conclusion of the ABC Annual Members Meeting. My comments were meant to assure the membership that as the incoming President, I understand ABC must adapt and change at a pace and in proportion to that of our membership; making the most of the resources available at a time we are all resource constrained. Read Full Post >


Do You Get What You Pay For? Maybe Not.

You will be greatly surprised that I have issues with the new administration. Most are not directly relevant to the blood community, but one certainly is. The Tr*mp administration proposes an 18 percent decrease in the taxpayer-funded budget at the National Institutes of Health (NIH)—a decrease of $5.8 billion. As one who has reviewed many transfusion medicine grant applications for NIH, I can promise you that the best fundamental science being done in our discipline is paid for by NIH. Adding insult to injury, the Fogarty International Center, whose sole purpose is support of international health, is specifically targeted. Read Full Post >


Blood Operations, Our Special Job; Advocacy For Our Special Needs

The members of ABC are special—we provide a unique service which requires special talents. We have to optimize the safety of donation for donors while ensuring an adequate supply of blood components for patients. We have to balance the need for the highest level of safety of blood to be transfused with the various costs of that safety: testing costs, product loss, donor loss or frustration. We have to do all this within the context of fiscal challenges and price-pressures that are part of the relentless drive to reduce overall medical costs. In short, we are blood operators. Read Full Post >


A Strategic Focus on Donors

With ABC and ADRP joining forces last fall, we gained not only a tremendous asset in the world of donor recruitment, but strategically positioned ourselves to confront the future challenges of a changing donor demographic. The ABC/ADRP partnership will not only provide first-class educational opportunities to various disciplines at the center-level, but will also ensure that as a community and association we have even greater resources to confront regulatory changes to donor qualifications and an ability to monitor trends on an international level. Read Full Post >


Premium Essential

A fashionable shop in San Francisco prides itself as a purveyor of "Premium Essentials" with the tagline "Fewer, Better Things." This phrase gives me pause to reflect on the nature of the premium essentials for ABC members. For this week's "Our Space" I have whittled down recent ABC activities to highlight examples of "fewer, better things" that provide premium essentials to our blood centers. Read Full Post >


I’ve Seen the Light; I Think it’s a Train

It’s no surprise to find “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” [emphasis added] on top of the 2017 CBER guidance agenda. It was good to see “Implementation of Pathogen-Reduction (PR) Measures to Reduce the Risks of Transfusion-Transmissible Infections in Transfused Platelets and Plasma” at number two. Our blood center implemented platelet PR nearly a year ago and we’ve been watching the guidance carefully; but what I thought was a light at the end of the tunnel turns out to be a train bearing down on us all. Read Full Post >


Ways to Contribute to the Cause

As the end of our fiscal year approaches, the Foundation for ABC (FABC) is taking stock of its accomplishments. In the past two years we have raised over $500,000 in support of the ABC Professional Institute (API); funded scholarships for emerging leaders to attend ABC Meetings and Specialty workshops; and revised our bylaws and re-established our relationship with ABC—resulting in a reduction of administrative costs and enabling a larger portion of collected donations to directly fund our projects. Read Full Post >


A Treasure Trove of Data Awaits

At ABC’s recent board retreat, it became apparent that collating and analyzing member data in an actionable form is a key strategy for ABC. That got me thinking, developing robust data strategy is not unique to ABC as an organization, but is also critical for each of our member blood centers. Data is an ubiquitous commodity generated across an entire organization, amplified by vastly reduced data storage costs over the last few years, resulting in a remarkable amount and variety of data being available. IT applications are also increasingly specialized and focused on different areas of business operations, which results in data becoming ever-increasingly siloed into “data islands.” Read Full Post >


Getting Ahead of the Game

The Food and Drug Administration (FDA) does not have any blood donors, much less millions of them. But ABC does. Advocacy is a key value of ABC, an activity highly prized by our members. One reason for an association to exist is that members share common goals in approaching the rule-makers and budget-makers, especially in a field as regulated as blood banking. But there are many types of advocacy, with different time horizons and probabilities of success. We have an opportunity now to work on “preventive advocacy”- that is, doing something ourselves to prevent or inform future regulations. Read Full Post >


Avert Your Eyes: Making Sausages, I Mean Policy

The new “Common Rule” for the protection of human research subjects is published and available. The Common Rule governed 15 federal departments and agencies, evolving from the early 1970s and 1980s as the National Research Act. The Department of Health and Human Services’ 45 CFR 46 responded to the “Tuskegee Study of Untreated Syphilis in the Negro Male,” initiated in 1932, that abused research subjects by neither educating them about the studies they were in, nor providing standard-of-care curative treatments as they became available. It entered the code in its most recent incarnation in 1991. A Notice of Proposed Rule Making was published for comment in September 2015, representing a “wish list” from 16 federal entities (excluding the Food and Drug Administration). This first major revision was in response to deaths among contemporary research participants, perceived gaps in the local application of the rule and, critically to me, the changing nature of research, including the proliferation of multisite trials and logarithmic expansion of genomic studies. Among its goals was an extension of protections to subjects in all clinical trials at sites receiving ANY federal funding; an enhancement and streamlining of informed consent; and redefinition of even anonymized human biospecimens as “human subjects” to extend to them a requirement for informed consent and tracking. Read Full Post >


A Call to Service

This week, a call for committee volunteer members was issued to ABC members for our fiscal years 2018 and 2019. ABC committee volunteers are the backbone of ABC and represent the best and brightest from throughout the industry. The altruistic spirit of these volunteers pushes the needle forward in work that spans all segments of the blood center. Simply put, we couldn’t do it without you. Read Full Post >


An Investment that Pays the Best Interest

A new year begins with new challenges, a new administration in the White House, new legislators, and a plethora of issues for blood bankers—some new and some ongoing. Against the backdrop of so much change, what is the value of ABC to its members and why must we continue to speak as a single trade organization with one strong voice? Read Full Post >


A Look Back With a Focus on the Future

President Dwight D. Eisenhower once said, “Politics ought to be the part-time profession of every citizen.” With this week’s ABC Newsletter covering the priority topics faced by the blood community in 2016, we are reminded of the tremendous work that has been accomplished this year. Perhaps even more important, however, should be the future of our industry and how our last year motivates each of us to face the compounding challenges in 2017 and beyond. Read Full Post >


Tis the Season!

I have shoveled the first snowfall of the year. Luckily, I finished cleaning up the last of the leaves and exchanged the rake for the snow shovel just as the first flakes of snow started to fall. It came on the heels of the horrific fires in Gatlinburg and Oakland that caused so much death and destruction. I tend to put out disaster preparedness reminders once or twice a year, unfortunately, I get reminded after such tragedies occur. So here it is for Fall 2016. Read Full Post >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >


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 >



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 >


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 >


Bringing Transfusion Practice into the 21st Century

Last year, America’s Blood Centers created the Transfusion Safety Committee as a subcommittee of ABC’s Scientific, Medical, and Technical (SMT) Committee. Our charge is to organize and promote the integration of ABC centers with their customers through transfusion safety officer (TSO) services, including patient edu-cation, clinical staff education, and patient blood management. We developed a transfusion safety project list via a survey of the ABC Transfusion Safety Forum members. Read Full Post >


Spreading the Word

Last week marked the end of a successful America’s Blood Centers-led grassroots campaign, culminating in the submission of two comment letters from ABC within a one week period and a face-to-face meeting with the Centers for Medicare & Medicaid Services (CMS) and the blood community delegation. During the past seven days, ABC has commented to CMS in opposition to the proposed cuts in reimbursement for blood and blood products, as well as to the Department of Labor expressing concern about the impact of the proposed increase in the threshold for exempt status and payment of overtime on non-profit organizations like blood centers. Read Full Post >


For Some Years, I Have Been Afflicted with the Belief that Flight is Possible to Man – Wilbur Wright

My grandparents had beach cottages at Nags Head, on the Outer Banks of North Carolina. We went there almost every summer while I was growing up. Mostly, I remember playing in the surf and watching the adults play long, spirited games of Monopoly. There was always a trip up the beach to Kill Devil Hills where the obelisk of the Wright Brothers Memorial sits atop a small dune, and to the museum with tools and models of their early planes, which they tested in the winds off the ocean. Read Full Post >


Innovation Over Faster Horses and Great White Whales

Economic pressures within the healthcare industry and, specifically the blood enterprise, have exposed a red ocean of competition replete with sharks attacking for the lowest price, mercenaries invading territories to acquire new market share, and a landscape ringed by beachheads strategically positioned to stave off conquest for a shrinking transaction base. Mergers and acquisitions in the supply chain and customer base have yielded market consolidation and blood has become commoditized as hospital administrators squeeze every cent from the supply chain. Long gone is the laissez-faire magnanimity, once the hallmark of the blood banker, replaced instead by fierce competition for the lowest possible price with the fervor of Captain Ahab’s quest for the Moby Dick. Read Full Post >


Patient Blood Management: Some Comments from Others and Some From Us

“The Ethics of Bloodless Medicine,” published Aug. 14, was the last in a trilogy of articles in The New Yorker discussing lessons learned from transfusing, and not transfusing Jehovah’s Witnesses. The reports are in keeping with the magazine’s habit of regularly addressing medical topics (see also “The Excrement Experiment, How a stranger’s feces might save your life,” Nov. 24, 2014 and “Can AIDS be Cured? Researchers get close to outwitting a killer,” Dec. 15, 2014). Read Full Post >


When ‘Sorta You’ Isn’t You (or Why we Need the Data Warehouse)

Many of you may have seen the recent Esurance commercials with the theme “sorta you, isn’t you.” In one, Giants catcher Buster Posey runs into a maternity room ready to deliver a baby stating that he is “sorta like a doctor because he wears a glove and delivers in the clutch.” Needless to say, the expectant father so infatuated with Buster that he considers allowing him to deliver, but the expectant mother wants her physician, not someone “sorta like” her physician, to actually do the delivery. Read Full Post >


Are we Suicidal or … ?

I’m corresponding with a healthcare economist (that can’t be good) about framing the medical, insurance, and public health value of blood in light of historic and future safety and regulatory imperatives. The goal is to describe our business and how to make it sustainable. When Centers for Medicare and Medicaid Services (CMS) proposed cuts (≈30 percent on average) to outpatient reimbursement for blood were published in the Federal Register, adding to our fiscal miseries, my old pal asked: “Why is the market for human blood not creating the efficiencies among the suppliers that the demanders want, yet leaving them a normal [sic] profit?” Read Full Post >


Check Out ABC’s New Member Site

With the summer months upon us, and what may be considered a slightly slower pace, many of us use these quieter times around the office to catch up on tasks we’ve been putting off. While it can bring such simple satisfaction to cross items such as “clean out inbox” and “dust keyboard” from your to-do list, it is also the perfect time to take part in professional development. And, what better way to do so than by checking out America’s Blood Centers’ new Member Site launched just last month? Read Full Post >


Organizational Resistance and Resilience

Change seems to be everywhere in the blood community these days – evolving business relationships, new technologies such as pathogen reduction, and emerging transfusion-transmitted biological agents such as Babesia. The ever-changing regulatory landscape is another key element in our environment that can create commotion in the blood industry. Read Full Post >


Genetic Testing – What Does it Mean to us?

Blood centers are probably the largest providers of “genetic testing” for adults in the country. Of course, we do serological ABO and RhD typing on every sample. We can also test for many other antigen systems. Until recently this was a common way of doing paternity testing. We are doing ever more red cell genotyping and using these results to provide better patient care for patients with multiple antibodies, enriching our inventory of rare units. We screen for sickle cell trait in a substantial number of cases by both chemical and molecular methods. We are in the genetics world, whether we think of ourselves in that way or not. Read Full Post >


The Red, White, and Blue

Saturday is the Fourth of July – a day when we celebrate our country and our freedom. So it’s a particularly appropriate time to consider the relationship between the blood world and our government. (Okay, the decla-ration of independence was signed on July 4, establishing the anti-government; the government we have now was not really established until several years and a failed try later. But we will celebrate this government anyway.) Read Full Post >


Just Say No?

Donors often visit places where infections not (yet?) endemic in the US are spreading. Dengue and chikungunya viruses are the current hotties, with Zika and Ross River viruses coming on strong. Each of these viruses, like West Nile virus, is characterized by asymptomatic viremia – the virus circulating in the blood before any illness – for several days, which may pose a transfusion risk. Potential exposures to malaria exclude many such donors, but nowhere near all of them. A short deferral of 14-28 days after return from international travel will get these donors past the risk. Can we do it? Asked more directly, how would such a deferral affect the blood supply? Read Full Post >


An Organization Without Data is Doomed to Follow, Never Lead

This past week, I launched two important surveys on behalf of America’s Blood Centers to our members. Despite having retired from ABC in April, I agreed to conduct them again, because I have done them for several years and have learned from our members the importance of the final reports. The data from these two reports – the Executive Compensation Survey and the Financial Ratio Survey – have generated more discussion and are more useful to ABC members than most of the other surveys that I have facilitated. Read Full Post >


What is a “Member” and Why Does it Matter?

It seems like a simple question with a simple answer, but in the past year, America’s Blood Centers has been struggling to answer it. First, a member is a dues-paying entity. There are currently 65 members in the net-work (down from 78 when I joined ABC in 2002). For the official definition, we turn to the ABC Bylaws, in which an active member is defined as a US or Canadian government-licensed, non-profit community or re-gional blood program governed by an independent board of directors serving two or more hospitals. In reali-ty, however, members come in a variety of shapes and forms. The current healthcare environment, which has placed blood centers under strenuous financial pressure, has led to the adoption of both traditional and inno-vative business models that have reshaped ABC membership. Today, 76 percent of members fit the definition above. However, the remaining 24 percent are either independently licensed affiliates, units or divisions of other members (14 percent), holding companies (five percent), or “other” (academic, hospital-based, or non-US). Nothing prevents that 14 percent from being folded into their parent company’s membership, receiving the same membership benefits (minus the right to vote). Read Full Post >


Always Be Prepared

Spring has arrived, but unfortunately, with it comes tornado season brought on by the collision of warm air of the South and the colder air still creeping down from the North. As we’ve already seen in Oklahoma, spring tornadoes can be devastating. Memorial Day signaled the “unofficial” start of summer and just this week was the official start of hurricane season. This is always an opportune time to review local disaster/emergency operations plans. These should be reviewed at least annually, if not more frequently, with a critical eye. Below are some key questions to keep in mind when reviewing your plans. Read Full Post >


Standing on the Shoulders of Giants

Isaac Newton once wrote to rival Robert Hooke in 1676, “If I have seen further it is by standing on the shoulders of giants.” Many years ago, when I was a young “wet behind the ears” medical director of a small blood center in the middle of nowhere, I received a phone call that changed my professional life. Celso Bianco, MD, then-president of ABC, shocked me by calling to graciously invite me to serve as co-chair of ABC’s Scientific, Medical, and Technical (SMT) Committee, along with Lou Katz, MD. As a relative newbie from a small blood center, I felt inadequate in the face of such a challenge, but Celso assured me I would be provided lots of assistance. After consulting my CEO at the time, John Guthrie, I accepted Celso’s offer. I both survived and enjoyed my stint as SMT chair, going on to serve on other committees at both ABC and AABB. I tell this story partly to thank Celso and Lou, both of whom have become personal friends over the years, but also to highlight their generosity and graciousness in confidently handing the torch to the next generation. Read Full Post >


Why FDA Should Refer Babesia Policy Discussion to the ACBTSA

The Food and Drug Administration’s Blood Products Advisory Committee (BPAC), rejecting recommenda-tions from the blood community, endorsed nationwide serological testing for Babesia microti, combined with nucleic acid testing (NAT) of donations collected in high-risk states (see ABC, AABB statements). This means testing millions of donors with virtually no infection risk, consuming limited resources that might be better used elsewhere in pursuit of patient safety. The model presented to BPAC by the agency on the impact of testing is based on unvalidated diagnoses of babesiosis derived from Centers for Medicare & Medicaid Services (CMS) claims data in a population (elderly Medicare beneficiaries) that does not reflect donors (see BPAC issue summary). This is in contrast to direct evidence from prospective Babesia screening by the American Red Cross, suggesting that much more limited testing is just as protective as extended screening and more cost effective. Read Full Post >


Pathogen Reduction: What’s Changed in the Last Two Years?

When I last commented on pathogen reduction (PR) in an “Our Space” two years ago, there was a sense of hope that PR was at our doorstep. Cerus had just received the greenlight from FDA to submit Premarket Ap-proval applications for its Intercept system for platelets and for plasma, which gained licensure in 2014. Now, Terumo BCT has submitted an Investigational Device Exemption (IDE) to begin its MiPLATE study for the Mirasol PRT system for platelets, which is expected to lead to licensure of the system. Terumo BCT is also developing a PR platform for whole blood. Data from the company’s IMPROVE II feasibility study, focused on radiolabel recovery of red blood cells after 21 day storage from PR-treated whole blood, has been submit-ted as an abstract for the 2015 AABB meeting in Anaheim, Calif. Read Full Post >


The Value of Continuing Education

Shortly after completing my graduate education, I pondered how I would gain knowledge in the future, assuming it would come from my routine work activities. Surely just “doing my job” would keep me updated on issues affecting my environment and prepare me to meet challenges and accomplish goals. Well, not quite. Entering a tightly regulated industry that is highly reliant on technology and the ability to touch peoples’ hearts and minds left much to learn that could not be provided by on-the-job training alone. I am grateful that ABC invests in staff education and development to familiarize me with blood banking and association management – at the core of what we do. Read Full Post >


Technology: Use It Right

I once came across a quote online that read, “The whole idea is not about the choice between using or not using technology. The challenge is to use it right.” While that quote was unattributed, I could not agree more with whoever said it. Read Full Post >


Anemia Management and the Perioperative Surgical Home

While moving towards a value-based payment system has been disruptive to the healthcare industry, the benefits of these changes are now apparent in reduced patient complications and mortality due to a stronger focus on patient-centric care. As experts in transfusion medicine, we are vital to the patient care experience and it is essential to understand that improving patient outcomes is a top priority for our hospital partners. Through understanding the reimbursement process, blood centers can work alongside hospitals and physicians to share in the benefits of improved patient outcomes. This strategy is critical for blood centers to move our discussions away from blood product costs and to truly align ourselves as partners with the healthcare systems in our communities. Read Full Post >


A Walk in the Park

A study published in JAMA Internal Medicine suggested we may have been fooling ourselves a bit about the value of moderate exercise. Among Australians who exercised at all, the ratio of vigorous to moderate activity was an important predictor of mortality. This was true regardless of the total amount of exercise. Vigorous activity was defined as activity “that made you breathe harder or puff and pant,” like jogging, cycling, aerobics, or competitive tennis (“Social” tennis and gentle swimming were examples of moderate activity.) Controlling for various demographic, dietary, and physical factors, the amount of overall activity was important in reducing mortality. That is no surprise. Read Full Post >


How a Meeting Turned into an Event

Every March the ABC office is pulsing with energy. From early morning into the late evening, lots of synchronized teamwork takes place with every staff member playing a critical role, all to ensure the Annual Meeting runs without a hitch. This year was especially noteworthy; with several new features and announcements, we placed our focus on turning the meeting into an exceptional event. Read Full Post >


Involvement = Opportunity = Success

I never would have thought that 47 years ago, when interning for a local Certified Public Accounting (CPA) firm that performed the annual audit for the Community Blood Center of Greater Kansas City, that I would end up with a 40-plus-year career in blood banking. This will be my last opportunity to write an article for Our Space as an ABC staff member, so I thought I would use this opportunity to reminisce and share with you how ABC (formerly the Council of Community Blood Centers) has been a major part of my career. Read Full Post >


ABC Talks About Bugs in Platelets

Last fall, I said that a Food and Drug Administration Guidance on detection of bacteria in platelets was expected, and we got a draft in December. ABC’s Scientific, Medical, and Technical (SMT) group has spent the interval assembling comments on the guidance to submit to FDA. There is a strong sense that FDA’s approach in the draft is complex enough that the incentive of possibly extending platelet dating is inadequate to promote the critical intervention for sepsis mitigation, i.e. voluntary secondary bacterial testing with rapid assays or culture-based methods. ABC is asking that FDA reconsider and mandate the use of secondary testing in the transfusion service. Moreover, we propose simpler alternative strategies that would improve patient safety and allow extended platelet dating. For example, delaying primary culture until later in storage combined with the use of larger inocula in our culture systems will reduce the risk of bacterial contamination, while extending platelet storage to seven days without secondary testing. Such approaches are not perfect, but represent progress and would balance operational burdens and consumption of resources with a more flexible inventory. Going forward, we would be responsible for conducting surveillance to assess their impact and amending our approaches, when appropriate, based on the data. Read Full Post >


What We’ve Done For You Lately

Hopefully you attended Wednesday’s webinar on the recommendations of the ABC Dues Task Force and heard directly from ABC CEO Christine Zambricki about how ABC is working to accomplish our strategic goals. In the next couple of weeks, all ABC member CEOs and member voting representatives will receive their 2014 Member Value Report. I encourage you to review it and share it with your blood center colleagues. Read Full Post >


What About Fill Rate?

Effective patient blood management (PBM) is clearly an important principle in blood banking and, as part of any reasonable PBM approach, ensuring that we minimize waste is crucial to maintain credibility with our donors and control costs for our hospital customers. But blood product waste management does not equal PBM, and single-focused efforts on waste management could produce unintended (and unacceptable) consequences. In addition to the clinical aspects of PBM, I firmly believe any waste management initiative should have product “fill rate” as a crucial measure of success. If we do not include such a basic measure of performance in our studies and management strategies, we run the risk of cutting waste at the cost of reduced product availability. But how do we measure fill rate? How do we define it? Read Full Post >


Checking Our Iron Will

“Just let me check your iron,” the nice phlebotomist says to the prospective blood donor as she reaches to do the fingerstick. If only!! We do not in fact check anyone’s iron level; we check hemoglobin. While iron is necessary to produce hemoglobin, there is no direct relationship between the two. Even donors meeting our hemoglobin standard will, especially with repeated donation, have reduced iron stores. Low iron stores have been associated with fatigue, mental changes, and decreased exercise capacity. Last week, the Newsletter highlighted the Hemoglobin and Iron Recovery Study (HEIRS), which provided direct evidence that giving donors iron pills can reduce the time until hemoglobin level and iron stores are replaced. Should blood centers act on this and give our donors iron? Read Full Post >


No Experience Required

Are you the type of person who makes a to-do list? If so, I hope that the No. 1 item is your Capitol Hill visit on Tuesday, March 24, in conjunction with the ABC Annual Meeting. If you are like me, your to-do list needs specific boxes to check off. Here at ABC, we’ve taken the guess work out of your planning. Start early and you will be ready for this premier grassroots advocacy opportunity. Believe me, your members of Congress (MOC) will be delighted to meet with you, their constituent. Read Full Post >


Pathogen Reduction & Platelets: Are We Inflating Our Balls Enough?

The Food and Drug Administration has approved a pathogen reduction (PR) process for platelets. For much of my career, this would have been as big a deal as finding the grail. But, in the weeks since, I have heard (a not unexpected chorus) telling me that “we” cannot afford it. There are two “we’s” in this opera. The first is the blood community, living with the realities of DRG (diagnosis related group) reimbursement and horrid pressures to cut our prices to hospitals. It will cost more than $50 per platelet dose, and we do not think we can pass it through. The second “we” is the hospitals. They may have higher safety priorities (consider healthcare-associated infections, medication errors, falls), and don’t think the main driver for platelet PR – bacterial contamination of platelets – merits the use of limited resources. I would have more sympathy for the latter argument if I believed dollars not spent to fix platelet sepsis would be diverted to the “larger” issues. Read Full Post >


I Didn’t Know What I Didn’t Know

I’d like to tell you I entered the Army solely out of patriotism. The truth is, my father strongly suggested it because he thought I was lazy and undisciplined. As it turned out, it was an excellent experience and a strong sense of patriotism eventually followed. I often wondered if I would have developed a similar sense of responsibility without the rather abrupt culture change introduced by my basic training drill sergeant and nine years in the Army. In retrospect, I think my military service accelerated changes that would have occurred regardless as I matured. Then again, compared to my father, I’m still lazy and undisciplined. Read Full Post >


Bring Back the Table

Is it time to bring back the big table for ABC Member Meetings? ABC’s history is rooted in a time when business was conducted with every ABC member CEO seated at a large rectangular table. The story goes that the table got bigger and bigger. Eventually a new leadership paradigm was necessary, and our current governance model with a board of directors was born. Read Full Post >


Introducing the ABC Business Forum

By now, I hope you have had a chance to review the upcoming ABC Annual Meeting program. You will notice an interesting new addition to the program: “The ABC Business Forum: The Economics of Plasma,” on Saturday, March 21. This addition could not be timelier or more relevant. First, it complements the executive management and scientific and medical discussions in the Blood Center Leadership and SMT Forums by providing valuable information and education on the operations side of blood banking. Second, it ties in with ABC’s current advocacy agenda on the issue of plasma flexibility. Read Full Post >


Vote Early and Vote Often

Brace yourself. Get ready … “ABC’s Got Talent” has arrived! Experience ABC supporters including CEOs, blood center employees, and even family members and friends of blood centers like you’ve never seen them before, all while raising money for a good cause. This week kicks off “ABC’s Got Talent,” a truly fun fundraiser. So, what do you need to do? Read Full Post >


The Value of Blood

I’ve long been fascinated by cost accounting in blood bank operations. We often talk about the cost of producing a red cell unit. But is this the right way to think about our costs? I do not think so. Read Full Post >


'Tis The Season

As the holidays approach, many begin to ponder which charitable organizations they would like to support. We hope that you consider the Foundation for America’s Blood Centers (FABC) in your charitable gift planning this year! 2014 has been an exciting year for both ABC and the FABC. Read Full Post >


Washington Matters

The Food and Drug Administration is working with ABC and the blood community to promote the most efficient use of apheresis plasma from unpaid volunteer donors for further manufacturing into life-saving derivatives, according to Jay Epstein, MD, director of FDA’s Office of Blood Research and Review (OBRR) in the Center for Biologics Evaluation and Research (CBER). An ABC delegation including President Dave Green, President-Elect Susan Rossmann, MD, PhD, Chief Medical Officer Louis Katz, MD, and myself, met at the FDA White Oak campus yesterday with OBRR representatives to discuss these plasma requirements and other topics of interest to ABC members. In addition to Dr. Epstein, key members of the OBRR leadership team participated in the meeting. Read Full Post >


Paving the Way for the ABC Professional Institute

Last week, members of the ABC Professional Institute (API) Curriculum Development Committee, and invited guests, gathered in the ABC office for a retreat to scope out and prioritize the services and products offered to members through the API, which is currently under development. Led by committee chair and facilitator, Michelle Johnson, from Carter BloodCare, the group spent a day sorting through the results of a recent membership survey about the API, and worked to identify the content of potential subjects and certificate programs that would be of value to ABC members. Read Full Post >


Déjà Vu All Over Again?

The year 2004 saw the Summer Olympics return to its starting place in Athens, Greece. New England dominated the USA professional sports world with the New England Patriots winning the Super Bowl and the Red Sox the World Series. Oh – and red cell demand for independent blood centers was approximately the same as it is today. What happened to the decline in demand!? Read Full Post >


How Do We Honor an Industry Visionary?

Earlier this year, we lost a respected leader in the blood banking community – one who was recognized for his financial acumen, industry vision, and perhaps most importantly, his ability to put aside personal feelings and unite those with opposing viewpoints for the greater good. Jerry Haarmann, who you likely know as the guiding force behind Group Services for America’s Blood Centers (GSABC), was not only a visionary, but also a friend and mentor to many of us. Read Full Post >


Still Time to Let Your Talent Shine

Who said blood bankers’ talents are restricted to the blood center? Since we first introduced “ABC’s Got Talent,” the online virtual talent show fundraiser benefiting the Foundation for America’s Blood Centers (FABC), we have learned that our members have a multitude of rare and exciting talents. I do not want to give away any spoilers, but let me just say, blood bankers sure do keep things interesting. Read Full Post >


It’s the Vaccine Stupid!

The time is approaching for seasonal flu shots. In the US, uptake of flu vaccine on an annual basis remains disappointing. The Centers for Disease Control and Prevention estimates that only 42 per-cent of adults and 59 percent of kids were immunized during the last flu season. (I always remember the last time I missed my shot, in 1976 when I was an intern, and got influenza A while as-signed to a Department of Veterans Affairs medical ward. I was afraid I was not going to die.) The best thing I ever did in health care was to push for – and finally see – implementation of mandatory flu immunization in the hospital where I worked for 30 years. This came after it became clear that rational, evidence-based appeals to patient and personal safety were met with unacceptable vaccine uptake. Read Full Post >


Three Days in the Life

It’s the bowling pins on the corner table, each decorated in a different human form, complete with faces and clothes, that grab your attention immediately upon entering the reception area. Looking up, there is less than an inch between each of the photos featuring smiling blood donors lining every wall, heralding the gallons given by community members. Handmade quilts warm the walls of the donor room. The phlebotomist smiles, welcoming a favorite donor and neighbor. Recruiters don funny glasses and a fake mustache to add a personal touch of humor when scheduling the next appointment. Read Full Post >


The Light at the End of the Tunnel May be the Train

AABB’s Standards have required “methods to limit and to detect or inactivate bacteria in all platelet compo-nents” for almost 10 years. In 2012, the Blood Products Advisory Committee (BPAC) voted that “additional measures are needed to decrease the current risk of transfusion of bacterially-contaminated platelet products,” and FDA is writing guidance that will standardize our approaches. ABC centers are asking me about the pend-ing guidance, but guessing the timing or content of agency guidance is not often fruitful; however, the op-tions available aren’t rocket science. Read Full Post >


Tomorrow’s Donor Base — Take Two

Last week in this space, ABC President Dave Green wondered about the makeup of tomorrow’s donor base to meet future transfusion needs. He correctly stated that finding the right answer in the current environment is key. With other seemingly more urgent priorities, he urged us not to lose sight of this issue and to ensure donor relationship management practices are prepared to recruit and retain future donors. Dave, I’m glad you brought it up! Read Full Post >


Tomorrow’s Donor Base

What will our donor base need to look like to meet the transfusion needs of tomorrow? This is perhaps an odd question to ask when the past five years have been characterized by unprecedented declines in blood use and a struggle to take out capacity and reduce costs. Answering this question can also be easily postponed in favor of identifying solutions to near-term problems like chikungunya virus, or resolving long-term issues, such as our inability to convert concurrent plasma for fractionation. But it will require an answer nonetheless, and I believe it will constitute a major challenge for us all. Read Full Post >


With a Little Help From Our Friends

Last week, the blood community and 10 organizations representing patients with rare diseases sent letters to the Food and Drug Administration in support of the blood community’s initiative for regulatory harmonization. Specifically, these organizations are seeking the regulatory flexibility for blood centers to manage apheresis plasma efficiently, as they do recovered plasma from whole blood, so that it can be shipped for manufacture into plasma protein therapies at any time after collection. This regulatory change will advance population health by addressing the unique needs of patients with rare diseases that use life-saving plasma protein therapies. Read Full Post >


Never Fail to Astonish the Customer

“Be everywhere, do everything, and never fail to astonish the customer.” For an avid shopper like myself, it is hard for me to find fault with Macy’s, the retail giant who developed this customer service mantra. But as an association aiming to not only provide excellent customer service, but also valuable resources, information, and programs to a diverse membership, we have recently taken to focusing on delivering on our four core values (Innovation, Data Integration, Education and Advocacy), instead of providing the “everything.” Read Full Post >


Ebola R’ Us?

I am fielding questions from my blood bank pals about any impact of the Ebola epidemic in West Africa on transfusion medicine here. I understand Ebola transmission dynamics in the context of the deleterious impact of lack of development (and mistrust of “experts”) in sub-Saharan Africa compared to here. As a result, I pretty much dismissed Ebola as an important threat to what we do in the US – even given the lightning speed of international travel, as discussed in this week’s commentary by Anthony S. Fauci, MD, in The New Eng-land Journal of Medicine. Read Full Post >


Making the Case for Big Data (aka, ABC’s Data Warehouse)

On July 22, America’s Blood Centers Data Warehouse Requirements Advisory Committee (DWRAC) held its first face-to-face member meeting in Chicago. We sought to define how the warehouse can be used to help member organizations identify opportunities for improvement and support national ABC advocacy efforts that represent our views. Read Full Post >


Bylaws Anyone?

Once again, ABC’s board of directors will hold an open bylaws hearing at the upcoming Summer Meeting in Seattle at 7 a.m. on Aug. 7, prior to the scheduled 8 a.m. Members Meeting to vote on several amendments to ABC’s bylaws. This hearing follows a webinar on the ABC bylaws amendments held earlier this week, during which Rick Axelrod, MD, ABC’s vice president and chair of the Bylaws Committee, discussed the amendments proposed by the Bylaws Committee. The hearing is intended to offer ample opportunity for members to raise questions or concerns regarding the changes contemplated. A cursory review of the changes may suggest minimal controversy and maximum “tweaking;” indeed, there are many minor changes included. Yet I strongly encourage your participation in the open hearing and careful consideration before voting. Read Full Post >


Backyard Games and Blood Bankers

You may have heard about the Foundation for America’s Blood Centers’ Cornament and Silent Auction taking place at America’s Blood Centers’ Summer Meeting in Seattle on Aug. 5 and wondered what a bean bag toss game – generally reserved for backyard barbeques – or a silent auction – generally found at black tie events – has to do with the ABC Summer Meeting. The answer is not a whole lot. However, what we hope to accomplish through these events is to provide our member and industry supporters with more opportunities to learn about the programs that are funded through the FABC and why we continuously need your support. Read Full Post >


Backyard Games and Blood Bankers

You may have heard about the Foundation for America’s Blood Centers’ Cornament and Silent Auction taking place at America’s Blood Centers’ Summer Meeting in Seattle on Aug. 5 and wondered what a bean bag toss game – generally reserved for backyard barbeques – or a silent auction – generally found at black tie events – has to do with the ABC Summer Meeting. The answer is not a whole lot. However, what we hope to accomplish through these events is to provide our member and industry supporters with more opportunities to learn about the programs that are funded through the FABC and why we continuously need your support. Read Full Post >


Iron or Rust? A Meta-Analysis on Blood Donor Iron Supplementation

Stephen Vamvakas, MD, PhD, a master of meta-analysis, used to quip that performing meta-analyses means never having to do your own study! Meta-analyses combine similar studies to increase statistical power of conclusions. The Cochrane group recently analyzed blood donor iron stores and replacement. Read Full Post >


The Sting of Transparency

There is an increasing movement toward pricing transparency for hospitals and providers. As previously reported in the ABC Newsletter, the Centers for Medicare & Medicaid Services has released massive databases with information on Medicare payments to hospitals, physicians, and other non-hospital providers. In addition, three large insurers have announced that they are establishing a similar online database of paid claims. Also evolving very rapidly are state-level All-Payer Claims Databases (APCDs). More than 30 states have established or shown a strong interest in APCDs, large databases that systematically collect medical claims, pharmacy claims, and provider files from private and governmental payers to obtain multipayer data that allow stakeholders to understand the cost, quality, and utilization of health care in their region. Read Full Post >


Meet Us In Seattle

What’s not to love about the emerald city? The modern skyline, the futuristic space needle, the coffee culture, the lush green surroundings, and the Cascades – add to that the ABC Summer Meeting – and you’ve got a perfect summer getaway! We are heading to Seattle and we couldn’t be happier with the program. Puget Sound Blood Center will be hosting the 52nd Summer Meeting and we hope that you will meet us there. Read Full Post >


State Fairs and Blood Bank Associations

The York County Fair happens once every year and when I was growing up back in south central Penn-sylvania, it was exciting for me to attend the fair. I got much the same feeling last month when I was fortunate enough to be able to attend a couple of state blood bank annual meetings for the first time in a few years. Read Full Post >


On “Big Data”

I have been extremely fortunate over the years to have known some exceptional thinkers, strategists, and visionaries. Their counsel has been instrumental in whatever success I have enjoyed, and in the case of those mentors outside blood banking, their insights into the challenges and opportunities that they have faced in their respective industries and which may impact our world, have been quite instructive. Such is the case with a board member and mentor from my former employer, who happens to also own a bank (I’ll call him Joe). Read Full Post >


The Buck Stops ... Where?

America’s Blood Centers’ board of directors owns responsibility for the performance of ABC. As is the case with any organization, the buck stops with the directors and officers. Granted, boards hire, evaluate, compensate, and retain a CEO with the expectation that this individual will oversee the operations of the enterprise. But in doing so, boards must step up and not blindly follow the lead of the CEO. Rather, they must spend considerable time on strategic issues such as oversight, planning, enviro-scanning and assessing organizational risk. ABC’s board is doing just that. Read Full Post >


The Catchphrase Patient Blood Management has Been Hijacked!

Appropriate transfusion is good for patients. Blood transfusion saves lives every day. However, benefits of transfusion are not included among the data collected by patient blood management (PBM) and hemovigilance programs. We need to develop indicators and count successes of transfusions therapy. Read Full Post >


Together is Always Better

A lot has changed in the past three months. While my days of caring for a newborn have been filled with diapers, feedings, and copious amounts of coffee, my colleagues at America’s Blood Centers have been working diligently to continue to strategize and implement ways to better align ourselves with the needs of ABC member organizations. I was happy to hear that part of this strategy is to officially merge my work with the Foundation for America’s Blood Centers (FABC) with the work of the Member and External Relations department at ABC. Read Full Post >


Coming Soon to a Screen Near You: Your One Source for Blood Banking Staff Development and Learning

It has never been easier to access information – with the click of a mouse and a few key strokes, you can find just about anything on the Internet. For trade associations and customer service organizations alike, it has become clear that an organization’s website is crucial to its success. An entity’s website serves as its “public face” and is generally the first place customers look to answer questions or find resources. Read Full Post >


Collective Responsibility is Red, White, and Blue

Collective responsibility is an elementary principle of organizational life. ABC members have the opportunity to vote on two bylaw changes via webinar on May 14, 2014 at 2 p.m. EDT or by submitting a proxy ballot by COB May 12. Read Full Post >


Don’t Say I Haven’t Said Anything Nice About FDA Recently

The Food and Drug Administration’s Center for Biologics Evaluation and Research and Center for De-vices and Radiological Health has issued a draft guidance (available at http://1.usa.gov/1nEBjUq). It describes the statutory and regulatory foundations permitting the agency to approve “Premarket Approval” (PMA) applications for medical devices even when all of the data that FDA requires are not available at the time of approval. The lynchpin is that “FDA believes that applying postmarket controls in order to reduce premarket data collection, when appropriate, improves patient access to safe and effective medical devices that are important to the public health.” The Food, Drug and Cosmetics Act requires that FDA use the “least burdensome” data requests to establish the effectiveness of a device and that “probable benefits” be weighed against “probable risks.” Read Full Post >


On Advocacy

This week’s ABC Newsletter details our active advocacy agenda developed by the Government Affairs Committee, based on your input. We have an ambitious agenda designed to tackle some long-standing issues, as well as emerging opportunities. Our overall intent is to shape the legislative and regulatory environment in a way that enhances our members’ ability to succeed in a challenging and fluid era. The ABC staff is capable and prepared to drive this agenda, but of critical importance is the active engagement by all of us in educating our national and local elected and administrative officials about the importance of these initiatives. Read Full Post >


Eventually We’ll Get It Right

There’s nothing like a reunion for making you feel old – and different, and special, perhaps. Last week, I went to the 25th reunion of my medical school class (Baylor College of Medicine, 1989). The events seemed to represent what’s happening in health care today, specifically some of the issues facing America’s Blood Centers. Read Full Post >


Not Much Happening in the Real World, So I’ll Update You On Mine

Chikungunya virus - named from a word in the Kimakonde language meaning "to become contorted," describing the stooped over appearance of its victims crippled with joint pain. This acute mosquito-borne infection of African origin has caused titanic epidemics in the Indian Ocean and South Asia during the past decade. Since early December 2013, more than 20,000 cases have been detected in the Caribbean and northern South America. There is no reason not to expect it to land on the US mainland, where competent vectors are common. The AABB Transfusion Transmitted Disease (TTD) Committee's Emerging Infections subgroup and FDA's Division of Emerging and Transfusion Transmitted Diseases have all been following the Caribbean outbreak closely. Read Full Post >


Information + Engagement = Good Decisions

Last week, America’s Blood Centers’ members came together in Palm Springs, Calif., for the 52nd Annual Meeting and 4th annual Links for Life Golf Tournament benefiting the Foundation for America’s Blood Centers. The work that went into organizing this particular meeting was unprecedented, not only for co-hosts Blood Systems, Inc. and LifeStream, as well as the ABC Meetings Committee, but also for the ABC staff. Read Full Post >


On Collegiality

Benjamin Graham was a noted Columbia Business School professor, author of “The Intelligent Investor,” and developer of the approach called Value Investing, on which Warren Buffett based his investment strategy. Ben Graham offered the following regarding cooperation and competition: “Competition creates better products, alliances create better companies.” This simple but compelling sentiment underlies in part the perspective on which the “Cooperate-to-Compete” theme, which has been incorporated into ABC’s meetings, is based. I would argue, however, there is an even more basic component to our long term success – maintaining our sense of collegiality. Read Full Post >


File Under the Heading of “No Good Deed Goes Unpunished”

related acute lung injury (TRALI) mitigation. They require whole blood and plasma for transfusion to come from donors who are unlikely to be alloimmunized to human leukocyte antigens (HLA), which have been associated with the risk of this transfusion reaction. It is a good bet that in the future, these expectations will expand to include apheresis platelet donors. A common approach to meet the Standards is screening donors at risk for alloimmunization for HLA antibodies using any of a variety of test kits. During recent Clinical Laboratory Improvement Amendments (CLIA) inspections of blood establishments, certain laboratories have been cited when testing for HLA antibodies because they are not CLIA-certified in the specialty of histocompatibility. At AABB’s request, CLIA has reviewed the issue and is maintaining this interpretation; so it is reasonable to expect more such citations. Read Full Post >


Shifting Organizational Culture Through Project Management

It has been slightly more than four years since I joined you in the blood industry, and what a four years it has been. While my tenure in our industry is short, I do understand rapid change and the challenges it creates for organizations and leaders, regardless of the industry. Evidence indicates that the changes we are experiencing in blood banking and healthcare at-large are unprecedented, creating tremendous challenges in our centers and in ourselves as leaders. The reality is clear – it’s not business as usual anymore. Read Full Post >


The Clock is Ticking

Whether talking about America’s Blood Centers or our member centers, there are two rudimentary contribu-tors to the financial equation. Decreasing costs and increasing revenue are essential to the bottom line. Sometimes trimming costs can be a delicate proposition. The need to meet or exceed member needs now and in the future must be balanced with the handling of short-term priorities. Often alternative sources of revenue are difficult to find. I would like to share with you today some of ABC’s activities to reduce costs and increase revenue as we strive to assure financial accountability to our members. Read Full Post >


Reconnecting Value to Satisfaction

Last week, the ABC board of directors, executive staff, and a handful of ABC committee chairs participated in the strategic “thinking” retreat in Dallas to develop the next strategic plan for your association. You will have an opportunity to review the draft plan in the coming weeks, prior to the Annual Meeting in Palm Springs, Calif., but before we get to that, I wanted to reflect on a point that was discussed at the retreat. Read Full Post >


We Need Your Voice

Blood Bank of Alaska (BBA) has many unique challenges due to our geographic location in relation to the lower 48, and the size of our service area. Alaska itself represents about 20 percent of the US landmass. No offense to Texas, but Alaska could easily fit two states the size of Texas within its borders with room to spare. Read Full Post >


Framing the Challenge: Decline or Shift

Not surprisingly the pace of change in how we interact with and support our hospitals continues at a brisk pace: hospitals joining systems, systems merging with systems, and mega-systems forming purchasing umbrellas. Our members are demonstrating creativity in expanding relationships with their customers, partnering to deliver unprecedented value, and forging new networks to extend their reach according to the evolving footprint of their customers. Amid these dramatic responses to an increasingly complex service environment, what responsibility do we have in making our donors aware of these changes? Read Full Post >


A Personal Reflection

It must be unusual for a single generation of docs to witness the glorious progress we have seen in the ability to control conditions that helped define a clinical epoch. Last week, the ABC Newsletter reported on two studies in the New England Journal of Medicine that described a treatment administered once daily for HCV infection with very well tolerated, all-oral drug regimens; these stand to replace some dauntingly toxic, injectable standard cocktails. They afforded apparent cure of infection in more than 90 percent of enrolled patients. The responses were independent of virus strain and other predictors of a poor response. Many giddily predict that we are seeing the coffin lid nailed down on a bug that is a leading cause for liver transplantation in this country and of end stage liver disease worldwide. Similarly, stepwise improvements since the mid-1990s in the ability to control – if not cure – HIV infection, have turned an infection associated with millions of grizzly deaths into a chronic process that under the right circumstances is held at bay with a single daily pill. Read Full Post >


Get Out of the Cold and Onto the Course

As much of the country continues to endure what seems like one polar vortex after another, many of us are holding out hope that Punxsutawney Phil does not see his shadow. However, instead of relying on a rodent to bring sunny weather, you should set your sights on the ABC Annual Meeting and Links for Life Golf Tournament in sunny Palm Springs, Calif. this March! Not only will you get out of the cold, but you will have the opportunity to support the Foundation for America’s Blood Centers (FABC) and have a great time golfing at one of the top golf destinations in the world. Read Full Post >


The Sustainability of Community Blood Centers

Sustainability has been generating much discussion within blood banking, and I believe there are three pillars of sustainability for community blood centers. The first is the continuing relevance of blood in medicine and surgery. A 2013 report on the blood banking industry by John Zeman and other experts suggest the demand for blood products and services will continue for the foreseeable future. The second pillar of sustainability is the market in which we operate, the changing realities of healthcare economics, and the supply chain. The third pillar is the business model(s) we select, or the “winning model(s).” There will likely continue to be winners and losers. I suspect not all winners will be large organizational entities, nor will all losers be small. Winning delivery models will be those blood centers that best execute what behavioral economics calls game theory, in which rational strategies and actions trump emotional attachments and decisions poorly grounded in realism. Read Full Post >


Be It Resolved

Happy new year! I hope your holiday season was filled with good health and much happiness. As so many do, I have put together a brief list of new year’s resolutions for 2014. Here are my top three. Read Full Post >


What’s Your Five Year Plan?

Much has been written about the uncertain times in blood banking, mainly due to the cost-cutting pressures within healthcare and the decrease in blood use. But something else is happening that has caught the attention of America’s Blood Centers’ executives – “en masse” retirements. In the last three months, three ABC member CEOs have turned over. The median age of an ABC member CEO or representative is 61, roughly five years away from retirement. We are facing a wave of baby boomers leaving the industry, which has implications not only to the communities they serve, but also to our association. Read Full Post >


‘Tis the Season

Every December, there is a flurry of association activity in Washington, D.C. ‘Tis the season for professional and trade organizations to finalize their federal advocacy agendas for the upcoming year. Read Full Post >


Disrupt Yourself

From Puget Sound, Wash. to Miami Beach, Fla., change is pervasive across the blood world. Community blood centers that were once unshakably loyal are seeking new leadership and value from America’s Blood Centers to guide them through a business climate that is almost unrecognizable from just a few years ago. This competitive and economically challenging environment has transformed member expectations, and the time is now to lead our organization into this new era, which is all about value to our blood center members. Read Full Post >


What’s Our Community ROA?

A cursory review of recent blood banking operations literature points to a rather dramatic shift (or de-cline, if you prefer) in core blood product demand and many speculate we will see more of the same over the next few years. If this is true (and I happen to believe it is), then we have an obvious problem of over-capacity. In the for-profit world, such a dilemma typically triggers industry leaders to investigate two questions: What does the demand characteristic of the future look like (in other words, how much change, how fast, and what impact will it have on our breakeven point?) – and – What are the barriers to exit should we need to move resources to another purpose? I will leave the challenges that blood banking faces with using dated national market information for a subsequent article. But I want to tackle the second question by asking how non-profits in general, and blood banks in particular, evaluate the exit question. Read Full Post >


Thicker than Water

This month I accepted the position as CEO of America’s Blood Centers. It is a privilege to be given the opportunity to work with this wonderful organization. I believe ABC’s future is full of promise and I am excited about what lies ahead. I am also aware that most of you do not know me, so I’d like to take this opportunity to introduce myself a bit. Read Full Post >


Charity Begins at Home

“Charity begins at home, but should not end there.” This quote has a number of variations and has been attributed to many authors over the years, but in the end, it always drives home the same point: to help the world, you must first start with the members of your immediate family and community. Then, slowly but surely, the ripple effect takes place. Read Full Post >


The Government May be Shutdown, but we Still Need You

As the partial government shutdown closes in on the end of its second week, and the world nervously turns its attention to the possible default of the US Treasury, there is a rather somber attitude in Washington D.C. and all over the country. Many are experiencing the “trickle-down effect” of the shutdown. It really hit me when I visited the Starbucks by the ABC office at 8 a.m. the other day. Normally, this particular branch tends to have a line out the door of caffeine junkies getting their fix, especially during the morning, but I was the only customer in the whole café that morning. The baristas confirmed it has been like that all week. Read Full Post >


Embracing Our New Leadership

On Sept. 20, America’s Blood Centers announced the hiring of Christine Zambricki, DNAP, CRNA, as ABC’s new CEO. I hope readers were as impressed as ABC staff was with her experience, skills, and qualifications. With her healthcare advocacy background, we couldn’t have asked for a better candidate to lead ABC at this very moment. Getting to Dr. Zambricki was not an easy process by any means. For starters, the ABC CEO Search Committee had to begin the search much earlier than anticipated. Thankfully, they were able to quickly develop search criteria that clearly defined the characteristics and skills of the new ABC leader. We were also fortunate to count on the assistance of a top talent search firm. The search firm initially reviewed 151 applicants, contacted 77, considered 11, interviewed eight and recommended four candidates to the committee. The Search Committee further narrowed the search to three candidates who appeared to meet the job description and desired CEO profile. After a round of interviews with committee members, Dr. Zambricki emerged as the top candidate and enthusiastically accepted the offer. Read Full Post >


Value-Added Services

I dislike the term “value-added.” I realize why the term exists and the importance of differentiating between delivering blood products and providing a comprehensive service approach to support hospitals. I just think the phrase somehow minimizes the very essence of the vital services that are often called “value-added." Read Full Post >


Leveraging Talents for Success

As this Newsletter goes to print, America’s Blood Centers’ 12th bi-annual Financial Management Work-shop will coming to a close. It is amazing how far this workshop has progressed since 1990 when a group of accountants, including me, decided that blood center financial professionals needed an opportunity to come together and share ideas. At this year’s workshop, titled “Financial Management: Thinking Strategically in an Uncertain World,” we discussed the “State of the Industry” from the blood center executive, supplier, and hospital viewpoints. Attendees heard presentations addressing whether our business models are sustainable, shared success stories on how to enhance the bottom-line, and much more. Read Full Post >


Jason and the Algorithms

I distinctly recall my aunt and uncle taking my cousins and me to a drive-in theater back in 1963 to see that year’s big special-effects film, “Jason and the Argonauts.” Based on Greek mythology, the hero Jason stood before Zeus and Hera in the heavenly Olympus and received direct guidance about how he might find and steal the Golden Fleece, which reminds me now of how I attend ABC meetings to derive enlightenment from conversations with my mythic colleagues at ABC. The gods offered Jason some support, but ultimately, he had to overcome many obstacles himself. There were two images from that film that remain vivid in my mind to this day. The first was when Jason battled the Hydra. Jason had to kill the many-headed monster in order to make off with the Golden Fleece. The other was the frightening moment when the skeletons broke out from the rocky earth with their swords and began battling Jason and his men. Read Full Post >


“Star Wars” or Looking for Trouble?

I always told my kids to be careful turning over rocks – there might be a scorpion there to sting them. The warning came from my clinical experience, watching colleagues test patients for infections that you could tell they did not have after talking to the patient, and coming up with false positive tests to explain away. The pathologists among us (at least those beyond a certain age) will remember “febrile agglutinins” in this context. Read Full Post >


Change for the Better

There has been a whole lot of talk about change lately – nationally, locally, and even personally, change has been a common subject of conversation. Our national healthcare system is embarking on some of the most drastic changes in history. Lately, my Facebook page has been filled with endless posts of what may be considered the quintessential symbol of change in the lives of parents and children – the first day of school picture. And of course, as everyone in blood banking knows, our industry is changing at a fast and furious pace, with many discussions among blood bank leaders focusing on what we can do to keep up. Read Full Post >


Why do we do What we do?

Yes, I know the primary reason that we “do what we do” is to help connect donors and patients by providing life-saving blood products. In this case, I’m asking a less meaningful, but in some ways perhaps more provocative, question – How are blood centers organized and will that organizational structure allow us to continue to “do what we do” best? I’ve been in blood banking for nearly a quarter century, yet I did not really seriously wrestle with this question until recently. Perhaps my reticence stemmed from needing a certain level of predictability in how I saw our role in the community, or that previous challenges did not require us to tackle these types of questions. However, I believe those answers are critical now. Read Full Post >


America's Blood Centers: Power in Numbers

You may already be aware, either by attending or hearing about it, that America’s Blood Centers just completed a very successful Summer Meeting (formerly the Interim Meeting). The meeting provided a great opportunity to reconnect with old friends while also making new ones. The BloodCenter of Wisconsin was the perfect host, even providing fantastic weather. Read Full Post >


Three Kinds of Lies: Lies, Damned Lies, and Statistics

Two recent reports appeared separately in the ABC Newsletter. The Healthcare Cost and Utilization Project (HCUP) Statistical Brief, #149 from the federal Agency for Healthcare Research and Quality lists transfusion as the most frequent procedure performed in US hospitals during 2010, while the 2011 National Blood Collection and Utilization Survey (NBCUS) shows significant decreases in blood transfusions since 2008. I have received inquiries about the apparent discrepancy between the reports, but there is probably no conflict – they count apples and oranges. Read Full Post >


To Shape the Future, Get Involved

Earlier this week, the Department of Health and Human Services published the 2011 National Blood Collection and Utilization Survey (NBCUS) Report (see page 1). The results will come as no surprise to blood bankers: blood collections are down, driven by the decrease in demand and perhaps the increase in patient blood management strategies. Overall, there has been about an 8 percent decrease in whole blood and red blood cell (RBC) transfusions – echoing what ABC members have reported and similar to rates reported by European Blood Alliance members. Read Full Post >


What on Earth do Railroads Have to do with Blood Banking?

I admit I was a bit skeptical when I learned that ABC’s Meetings Committee had arranged to have Mark Fagan from Harvard deliver a two hour presentation on how the railroad industry offers us insights into our unprecedented environmental challenges. After all, what do railroads have in common with blood banks? Following the truly dynamic and interactive session by Mr. Fagan at last March’s ABC Annual Meeting, I (and I believe other attendees) awakened to the incredible wealth of knowledge other indus-tries could offer in helping us thrive in difficult times. Based on the immensely positive feedback on this session, the Meetings Committee planned for the August ABC Interim Meeting in Milwaukee to build on the discussion started in March by welcoming Mr. Fagan back to help guide us through a discussion on how ABC should deliver value to you – ABC’s member blood centers. Read Full Post >


Let Our Past be Our Rock for the Future

Sometimes when you seem overwhelmed by the challenges of the future, it is comforting to look back at the past. Not that the challenges of the past were less daunting, but knowing that we met those challenges and survived brings peace of mind. Read Full Post >


The Perfect Sunny Day?

There’s the proverbial expression of what happens when many bad variables converge to bring us a “perfect storm.” I wondered recently what we might call it if industry, regulatory, and economic factors all became aligned after decades of discussion to finally bring us pathogen reduction (PR) for US blood products. Were that to happen, might we call this a “perfect sunny day?” Read Full Post >


Risk-Based Decision Making: More Questions than Answers?

There is international consensus that risk-based decision making’s time has come to the blood community. Diverse groups including, the Alliance of Blood Operators (an international group of national blood systems), and more recently, the Food and Drug Administration endorse it as the appropriate framework for creating transfusion safety policies. It’s hard to argue otherwise. In our arena, its foundation lies in understanding two things: resources for blood safety are limited and zero-risk is not attainable. Given the former, recognizing the latter leaves us with hard questions. At the top of the list is answering the question “How safe is safe enough?” – to which we respond, “According to whom?” Read Full Post >


Help Us Help You

Last year, America’s Blood Centers conducted its SEQuaLS member satisfaction survey, where ABC members could pose questions to the ABC and Foundation for America’s Blood Centers staff. One member asked, “Is there a way to make more grants available to member centers?” To provide the short answer – yes, the FABC is working to provide more useful grants to ABC members, but let’s start at the beginning. Read Full Post >


My Crystal Ball is Hazy

Either the strategic drivers shaping the blood community’s environment are at an all time high of flux, or I am suffering from bilateral uveitis – perhaps it is both. Regardless, my crystal ball has never been less clear. Read Full Post >


What Happened to the “I” ?

The acronym for America’s Blood Centers’ “core values,” IDEA, represents Innovation, Data Integration and Benchmarking, Education and Networking, and Advocacy. Although these values are not unique in themselves, they become powerful tools for ABC to serve its members. These tools are where the knowledge and leverage of all outweigh that of one. Read Full Post >


You Ought to Tell the Donor That

A young man donated double red cells at our center about a week before running a marathon; not surprisingly, his performance was awful, and he was angry with us. We didn’t know he was planning to run, and he didn’t know that donating would hurt his performance. After we explained, he calmed down, and said, “Well, you ought to tell the donor that.” How right he was. More and more, we realize donors should know much more about donation, in advance, and we are getting more sophisticated about what to tell them, and how. Read Full Post >


Advocacy Works – Sometimes More Quickly than Other Times

One year ago, an ABC member blood center applied for a variance from Food and Drug Administration labeling regulations requiring results on red blood cell (RBC) labels to be from samples collected “at the time of filling the … blood container” and “on a specimen taken … at the time of collection.” The center requested permission for inclusion of historical RBC phenotyping and genotyping on the integral labels of RBCs (i.e., the base label or attached tie tags). Read Full Post >


Building a Strong Foundation

Since we realigned and streamlined our core values, we came to the realization that not all values are created equal. Some values depend on others to thrive and accomplish their goals. We rely on three values to deliver ABC’s mission of helping community blood centers: advocacy, networking and education, and data integration and benchmarking. Data, however, is at the foundation of our core values and it is through data that we meet goals related to the other two core values. Read Full Post >


On Being Obsessively Data Driven

When I wrote my first “Our Space” column several weeks ago, I shared a draft with my confidant and former medical director, Dr. Louis Katz. His feedback was predictably direct: “I dislike passive voice and it seems quite fluffy.” Although I agreed with his feedback, I approved the draft, believing my first piece should be a bit …well, fluffy. I hope he appreciates the more direct approach this week. Read Full Post >


"Alone, we can do so little; together we can do so much" —Helen Keller

When I sat at my desk to write this, my first article for Our Space, I wondered where I should start. Unfortunately, the tragic events of the last couple of weeks have provided a starting point. Read Full Post >


Helping the Helpers

As with so many, my heart is broken over the explosions at the Boston Marathon. Although I cannot fathom the trauma suffered by the victims, families, and witnesses affected, the fact that it happened at a race hits close to home. My husband and his brother have run numerous marathons, I have many friends who run, and I am running a ten miler this weekend. However, because of yet another senseless act of violence ,the excitement of crossing the finish line will be overshadowed by the worry of being one step away from a similar tragedy. Read Full Post >


“Generals are Always Prepared to Fight the Last War”

I was a bit surprised to open Streetlights and Shadows: Searching for the Keys to Adaptive Decision Making, a book by Gary Klein, and find a well-thought-out discussion of a conundrum that has been nagging me my entire career: how do we optimally balance critical thinking, experience, and independent judgment with standardized metrics, standard operating procedures (SOPs), checklists, and job aids? Within the highly regulated and structured environment that we live in today, it may be easy to conclude that SOPs, intensive methodical data gathering, and articulated logic are the ways to achieve optimal safety. While they are incredibly important, especially within transfusion medicine, real-life decision making is messy and often no amount of pre-planning or data gathering will eliminate all risk. Perhaps this is the lesson the precautionary principle is really trying to tell us. Read Full Post >


Of Root Canals, Traffic Jams, and Brussels Sprouts

A recent survey found that Congress is less popular than root canals, traffic jams, and Brussels sprouts. Between partisan wrangling, brinksmanship, and the challenge of coming to agreement, it’s no wonder many would prefer eating their vegetables to watching the legislative process. Read Full Post >


You are ABC

I want to congratulate and thank America’s Blood Centers’ Meetings Committee, ABC staff and members for an excellent Annual Meeting event. The topics were compelling, participant engagement was excellent, and a professional discourse of the highest caliber occurred throughout. These characteristics reflect an association founded on sound fundamentals, which despite our recent change in leadership remain the cornerstone of our work. Indeed, an unwavering focus on our core values as an association has never been more important. Our challenges are daunting, but ABC’s tradition of quality service over the years argues for optimism in the face of these hurdles. Working together, we can leverage our collective expertise and talents to help us continue delivering excellent service for our communities. Read Full Post >