• Stop the Madness! Process Control Essentials for Effective Continual Improvement

    Lisa M. Walters, Ph.D., Principal Officer of Healthy Solutions Quality Consulting, LLC

    It is a dark and stormy night. Your facility is readying for what promises to be a challenging third-party review. You, the Quality Manager, along with your organization's General Manager, are reviewing a variety of the process monitoring data reports to prepare for the upcoming "grilling." One such report provides information regarding response times to the central monitoring alarm system, specifically for the reagent storage refrigerator.

    Full story
  • The Value of Performing a Good ValidationIn Transfusion Medicine

    Robin Nozick, MT(ASCP) CTO and Founder of R.F. Nozick and Associates

    The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for

    Full story
  • Minimizing the Risk of Donor Disease Transmission

    4 January, 2011 Emily Blumberg, Professor of Medicine and Program Director for the Infectious Diseases Fellowship Training Program, University of Pennsylvania

    Each year in the United States, nearly 30,000 people receive the opportunity to save, extend or enhance their lives through the human gift of organ donation. Of those, roughly three-fourths of the organs transplanted come from deceased donors.

    Full story
  • A Myriad of Documents - Is there Control?

    Marianne A. Silva, MS, MT(ASCP)SBB, CQA(ASQ)

    Document control is an issue for every laboratory. The words in the requirements seem so simple: control your documents. How can so much effort be involved in three words?

    Full story
  • Blood Bank ISBT 128 Implementation - Blood Industry

    David Linnemeyer, BS, MT(ASCP)SBB), Manager, East Jefferson General Hospital Blood Bank

    My own blood bank's ISBT implementation was not quick or easy. If I could do everything again, I would do things quite differently. Hopefully a review of my own mishaps will help you plan your own ISBT implementation more effectively.

    Full story
  • Legal Risks Affecting Blood Banks

    Cathy Burgess, Counsel, Crowell & Moring, LLP

    Blood banking is a high risk business. Some risks are obvious; others are not well understood. This article is by no means a comprehensive analysis of risks affecting blood banks. It identifies certain high risk areas and makes recommendations about risk mitigation, but is not intended to provide legal advice.

    Full story
  • ISTB 128 Sets Industry Safety Standard

    13 April, 2017 Dr. Michael Strong, former Vice-President of Research and Development at Genetic Systems and former Director of Laboratories and Chief Operating Officer at the Puget Sound Blood Center

    The key to satisfying these requirements lies in standardization: globally unique identifiers for products, standardized terminology and a means to convey information electronically that is recognized by computer systems throughout the world. Towards this end, ISBT 128 had been developed.

    Full story
  • Increasing Efficiency Through Lean Principles

    13 April, 2017 Rob Carpenter, Product Manager, Customer Relationship Manager and Blood and Biologics Expert, MasterControl, Inc.

    In today's economy many not-for-profit organizations have seen reserves eviscerated due to the stock market tumble. While the stock market has started to rebound, many not-for-profit agencies have also taken a hit on the philanthropic side. Donors are not able to be as generous as they have been in the past. The reserves that not-for-profits have been able to rely on to supplement operating funds are not there anymore. This has forced many organizations to look for other ways to reduce costs. W

    Full story
  • FDA Guidance Pertaining to Certain HCT/Ps: Three Recommended Actions

    13 April, 2017 MasterControl

    FDA Issues HCT/P Guidance

    Full story
  • What To Expect After an FDA Inspection

    13 April, 2017 MasterControl

    From blood supply to vaccines — blood establishments and biologics companies handle complex products that are fundamentally important to human life. It is no wonder that the industry faces some of the toughest regulations and standards today.

    Full story
  • PFDA, Community Meets to Discuss Priorities Article

    13 April, 2017 MasterControl

    Reviews issues discussed during a recent meeting of FDA and blood community representatives where the two groups presented and reviewed issues important to their operations.On Oct 04, 2007, Food and Drug Administration (FDA) staff met with AABB’s FDA Liaison Committee in Bethesda, MD, to discuss topics of mutual concern in the areas of donor and patient safety. The committee includes liaisons from AABB, the American Red Cross (ARC), America’s Blood Centers (ABC), Advanced Medic

    Full story
  • Editors Note - ISTB 128 Sets Industry Safety Standard

    MasterControl

    Robin Nozick wrote an article for the June issue of GxP Lifeline in which she erroneously referenced an unpublished version of the "ISBT Guidelines for Validation and Maintaining a Validated State in Blood Banking." Ms. Nozick regrets this mistake.

    Full story
  • Blood Community Meets to Discuss Priorities

    13 April, 2017 MasterControl

    Clearly, there is no substitute for blood. There is no substitute for safety in handling blood, either. From donations at blood and tissue centers to transfusions in hospitals, the primary concern is for the purity of this life-giving fluid. The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply.

    Full story
  • FDA Reports That Majority of Biological Product Deviation in 2006 Was Related to Post-Donation Information

    MasterControl

    The FDA received 38,618 biological product deviation (BDP) reports for fiscal year 2006, 72 percent of which stemmed from donor-suitability problems that were not detected during initial donor interview.Of the total BDP reports, 27,427 were under the category of ?post-donation information? (PDI), which means donor-suitability problems were discovered only during subsequent interviews with donors, according to a report released by the FDA's Center for Biologics Evaluation and Research (CBER) in M

    Full story
  • Designing a Learning and Performance Program in Tissue and Organ Banking

    13 April, 2017 David Hofstetter, Manager, Learning and Development, New England Organ Bank

    Keeping up with the changes and the training in tissue and organ banking is an ongoing process. We know what works well and what doesn't. We know with a field-based staff that classroom training is difficult to pull off when trying to coordinate everyone's schedules and of course working around the case load. What we have found is that online learning or on-demand learning does work. This allows all of the staff to access training when and where they need it. We currently offer the following typ

    Full story
  • The Changing Face of Biobanks

    13 April, 2017 Jeanene Swanson

    Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, S

    Full story
  • Blood & Biologics Lifeline - Health Canada Draft Guidance Issued in March

    Diane Whitworth, Principal Research Consultant, DRW Research & Information Services, LLC

    With Health Canada's recent publication of its draft guidance entitled, "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)," the agency has initiated its plan to introduce a comprehensive regulatory, legal and scientific framework to approve biologic products that are similar to already approved biologics upon patent expiration. These products, also referred to as biosimilars by the agency, have posed a regulatory challenge for government agencies worldwide. The Europ

    Full story
  • Blood Substitute's Effectiveness and Safety Addressed In Large Clinical Trial

    13 April, 2017 MasterControl

    A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells.Academic and industry researchers participated in a Phase III multi-center clinical trial and found that use of a blood substitute was relatively safe in patients under 80 years old who have a moderate need for transfusion, up to the equivalent of three units of regular blood.Published in the June edition of the Journal of Trauma® this study is the first

    Full story
  • Conferees Seek Paths to Improving Blood Center IT Systems

    13 April, 2017 MasterControl

    Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems.

    Full story