Blood Organizations Work With FDA to Resolve Problems Associated With Class-Wide Label Change to Alcohol-Based Skin Disinfectants
Due to well-documented risks of patient injury in surgical settings associated with the use of alcohol-based skin antiseptics and ignition sources — such as electrocautery devices and open lasers — a class-wide label change requiring revised language regarding minimum dry times was made to all products containing alcohol. New shipments of ChloraPrep skin antiseptic solution, which contains 2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol, will be accompanied by revised instructions for drying time; current instructions are for "approximately 30 seconds" and new instructions will be for a "minimum of 3 minutes." The revision is not in response to an issue with improper disinfection due to the shorter drying time; however, it imposes a considerable burden on the workflow for collecting units from blood donors. AABB, America's Blood Centers and the American Red Cross are working together with the Division of Nonprescription Clinical Evaluation within the Center for Drug Evaluation and Research and the Office of Blood Research and Review within the Center for Biologics Evaluation and Research, as well as CareFusion — the manufacturer of ChloraPrep — to find an option whereby blood establishments may continue to use the original instructions when the product is used in dry surgical sites. Individuals with questions may email AABB's Regulatory Affairs department.
Lance Trewhella Joins AABB as Patient Blood Management Director
Lance Trewhella has joined AABB as director of the association's Patient Blood Management program after a successful career as a patient blood management coordinator at the Mayo Clinic in Rochester, Minn. Among his accomplishments, Trewhella collaborated with a team at the Mayo Clinic that implemented an intensive care unit/operating room algorithm in cardiac surgery resulting in a 47 percent decrease in red blood cell transfusions and a 57 percent decrease in overall blood component transfusions within three months. The reductions continue to hold, three years after implementation of the algorithm. At AABB, Trewhella will apply his clinical experience and expertise in the development, management and coordination of the association's patient blood management activities. His specific goals include working with AABB's Education and Professional Development department to create additional educational programs focusing on patient blood management. Trewhella received a bachelor's degree in nursing from the University of Akron, Ohio, and currently is pursuing a master's degree in nursing informatics from Grand Canyon University, Ariz. Individuals with questions may email AABB's Patient Blood Management department.
Summary of AABB's FDA Liaison Committee Meeting Available Online
A summary of AABB's November FDA Liaison Committee meeting is now available. At the meeting, staff from FDA's Center for Biologics Evaluation and Research met with AABB's FDA Liaison Committee to discuss donor and patient safety and product manufacturing. Topics included the eligibility of donors based on legal gender and gender change, current donor testing requirements for hepatitis, donor deferral for those with a history of hepatitis after age 11, alternatives to the use of HCV RIBA, and labeling of units with historical red blood cell antigen testing results. AABB's FDA Liaison Committee includes representatives from the Advanced Medical Technology Association, America's Blood Centers, the American Red Cross, the Armed Services Blood Program and the College of American Pathologists.
CMS Publishes New Brochure on Assessing Personnel Competency
The Centers for Medicare and Medicaid, or CMS, has released a new brochure titled "What Do I Need to Do to Assess Personnel Competency?" The brochure outlines six procedures that serve as minimal regulatory requirements to assess competency for all personnel performing laboratory testing and includes frequently asked questions and answers regarding competency assessment. CMS requires a semiannual evaluation during the first year an individual tests patient specimens and an annual evaluation thereafter. Any changes in testing methodology or instrumentation require a re-evaluation of an individual's competency.
AABB is granted deemed status by CMS for the Clinical Laboratory Improvement Amendments, or CLIA, program. CLIA covers approximately 225,000 laboratory entities throughout the United States. More information is available online.
FDA Tissue Reference Group Releases FY 2012 Annual Report
The Office of Cellular, Tissue and Gene Therapies of the Center for Biologics Evaluation and Research has posted the Tissue Reference Group, or TRG, annual report of recommendations on the regulation of human cells, tissues and cellular and tissue-based products, or HCT/Ps. The fiscal year 2012 recommendations concern the application of Title 21 of the Code of Federal Regulations Part 1271.1, Part 1271.15 and Part 1271.20 to six HCT/Ps. The purpose of the TRG is to provide a single reference point across FDA centers for product-specific questions concerning jurisdiction and applicable regulation of HCT/Ps.
FDA Draft Guidance Addresses Electronic Submission of Regulatory Applications
The FDA announced the availability of the draft document titled "Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" in a Jan. 3 "Federal Register" notice. The draft guidance describes the FDA's plans to implement requirements for electronic submission of certain applications to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research. Twenty-four months after finalization, the guidance would require New Drug Applications, Abbreviated New Drug Applications, Biologics License Applications and Investigational New Drug Applications to be submitted using the electronic Common Technical Document, or eCTD, specifications.
CBER eSubmitter programs are used by the Office of Blood Research and Review for applications and supplement submissions related to whole blood and blood components, including source plasma. Licensure applications for minimally manipulated, unrelated allogeneic cord blood should be submitted using Form 356h. The deadline to submit comments on the draft is March 4.
January Audioconferences to Focus on Hemovigilance, RBC Transfusion and Transfusion-Transmitted Diseases
Upcoming AABB audioconferences in January will examine the topics of hemovigilance, red blood cell transfusion thresholds and transfusion-transmitted diseases. "Hemovigilance Report Generation and Analysis: How to Make the Most Out of Your Data" will review dataset generation, analysis and reporting from the Hemovigilance Module of the Centers for Disease Control and Prevention's National Healthcare Safety Network. This free Jan. 16 session also will cover how to use data from the Hemovigilance Module as a learning tool. A Jan. 23 audioconference will explore the current approach to RBC transfusion thresholds, analyzing how results from the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair, or FOCUS, trial and other studies may change transfusion practice. The final audioconference this month, to take place on Jan. 30, will provide an update on transfusion-transmitted diseases. Specifically, this audioconference will explore nucleic acid testing for the hepatitis B virus and the current status of testing for bacterial contamination of platelets.
Reminder: Deadline Approaching to Submit Comments on Revised 6th Edition of 'Standards for Cellular Therapies'
The 30-day comment period for the revised sixth edition of "Standards for Cellular Therapies" will conclude on Monday. This second comment period provides members an opportunity to review standards that have been added to the document since it was last released in August. The new standards — which are highlighted in an accompanying summary of changes — complete the expansion of the CT Standards into clinical activities related to patient care. AABB's Cellular Therapy Standards Program Unit encourages all interested individuals to submit comments. The draft document and instructions on how to submit comments are available online.
Reminder: AABB Requests Nominations for 2013, 2014 Memorial Awards
AABB is seeking nominations for its 2013 and 2014 Memorial Awards, which will honor individuals who have advanced the practice of transfusion medicine and cellular therapies. The awards are presented to recognize achievements in administration, immunohematology, quality and innovative research, and overall outstanding service. Individuals are encouraged to nominate candidates by completing and submitting the online nomination form by Jan. 25. Recipients will be honored at the 2013 AABB Annual Meeting in Denver or the 2014 AABB Annual Meeting in Philadelphia.
According to the National Blood Exchange, levels of Rh-positive blood types are high throughout parts of the country, and platelet products continue to rebound since the New Year's Day holiday. However, the demand for O-negative red blood cells exceeds supply, and several days are required to address all needs.
Requests for type AB frozen products are steady and national inventories are too low to meet this growing need. Quantities of other frozen products are plentiful.
AABB, 8101 Glenbrook Road, Bethesda, MD 20814
Managing Editor: Maryam Ali
Copyright 2013 AABB. All rights reserved.
January 15 – FDA: Cellular, Tissue and Gene Therapies Advisory Committee Meeting read more »
January 16 – AABB Audioconference: Hemovigilance Report Generation and Analysis
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January 23 – AABB Audioconference: Current Approach to RBC Transfusion Thresholds read more »
January 30 – AABB Audioconference: Transfusion-Transmitted Disease Update read more »
February 6 – AABB Audioconference: Blood Center's Role in the Management of Recipient Adverse Events read more »
Full Calendar read more »
New Web Resources
Reminder: CDC Rescinds Recommendation for Malaria Chemoprophylaxis for Travelers to Greece read more »
FDA Releases Guidance for Industry: "Refuse to Accept Policy for 510(k)s"
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HHS Publishes Semiannual Regulatory Agenda
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FDA Announces Tentative Meeting Schedule for 2013 Public Advisory Committees read more »