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02/24/2017

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 >

02/17/2017

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 >

02/10/2017

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 >

02/03/2017

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 >

01/27/2017

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 >

01/20/2017

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 >

01/13/2017

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 >

12/23/2016

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 >

12/16/2016

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 >