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2010 Spring Meeting Review Education info and links |
FREQUENTLY ASKED QUESTIONSTable of Contents
I have hereditary hemochromatosis and need to have blood taken each month as part of my treatment. This blood is discarded. I’m an otherwise healthy person. Is there anyway that I can donate my blood to benefit othersDr. Carolyn Hathaway Duchars, MD, Medical Director, Transfusion Medicine, St. John's Mercy Medical Center, St. Louis MO has provided this response: Blood collection agencies may request a variance from the FDA to collect blood from donors with hereditary hemochromatosis (HH) for allogeneic transfusion. There are several conditions that must be met to be approved and are as follows: 1. The donors must have been diagnosed with hereditary hemochromatosis (other causes of iron overload are not acceptable under this variance). 2. The donors must meet all other eligibility conditions as regular whole blood donors except that they may donate more often if prescribed by their physician and have been properly evaluated. 3. There must not be a charge for the collection of blood from people with HH regardless of whether their blood can be used or not. Our blood collection facility has applied for and been approved for this variance. We have been accepting blood donations from people with HH for a number of years and have been happy with the success of the program. Not only do we have more blood for our hospitalized patients but our HH donors fell better that their blood can be used for someone else's benefit. There may be a number of reasons why collection facilities choose not to apply for the variance. This variance is not limited to any geographical area; therefore, you may find collection facilities in your area that do accept the blood. This is a link to the list of facilities that have been granted approval for the variance: http://www.fda.gov/cber/blood/hemochromvar.htm When should the test for weak D be performed?Dr. Patel from the Community Blood Center of Kansas City has provided the following response: All blood donors are tested for weak D and will be labeled as D positive. Blood recipients do not need to be routinely tested for weak D, per the Standards. In fact, the majority of most current Anti D reagents will detect weak D, classifying the patient as D positive. There is a small risk these patients will develop Anti D if the patient has missing D epitopes (partial D). Weak D testing, Anti-D testing with addition of antihuman globulin (AHG) should be done to clarify typing discrepancies. Such as, when a patient has been previously typed as D negative and now types D positive (e.g. original type, from the distant past, and current type disagree, autologous D positive unit with previous D negative status). Another scenario warranting weak D testing is if a D positive individual appears to develop an apparent alloanti D and DAT negative. References: 1. AABB Standards for Blood Banks and Transfusion Services, 23rd Edition. 2. AABB Technical Manual, 15th Edition. Back to TopWhat are some of the issues with using a pneumatic tube system for delivering blood products?David Headings, Via Christi Regional Medical Center, has provided the following response: The overriding benefit for us in blood delivery via pneumatic tube system is the enormous savings of time it provides both for us and the nursing staff. We tube all our products routinely unless the system is not functioning (approx. 1800/month). Because of the size of one of our facilities, it may be a 10 minute walk to the Blood Bank from a nursing unit, and having staff available to come is always an issue for them. When nursing is ready for a product they call with the patient information, (i.e., name, unique armband number), nurse's name and tube location. The dispensing tech records that information in the LIS, along with their own name and the results of the inspection of the unit. Upon receipt, the nurse signs the compatibility paper and records date and time. This form is then used to record vitals during infusion, as well as report of adverse reaction if any. When infusion is complete this form is returned to the Blood Bank. We do have an occasional breakage, but the number is insignificant relative to the benefits. All products are double bagged so any leakage is contained. Causes of bag breakage remain under investigation. Back to TopHow often do antibodies need to be re-identified?Mary Kowalski MT(ASCP)SBB, Community Blood Center of Kansas City, has provided the following response:AABB Standard 5.13.3.3 states "In patients with
previously identified clinically significant antibodies, methods of testing
shall be those that identify additional clinically significant
antibodies." This can be accomplished in various ways; all fulfill the
standards requirement. Which method(s) you choose will depend on the type of
requests your transfusion service receives and your ability to provide blood in
a timely manner. Others test only selected cells that are negative for the antigen(s) corresponding to the patient's antibody (e.g., the patient's plasma contains Anti-D and only D - cells are tested) Lastly, others use results of the antibody screen in conjunction with antiglobulin crossmatch results on donor cells negative for antigen(s) corresponding to the patient's antibody. (i.e., If screen cell results are consistent with the known antibody and antigen negative units are compatible, no further testing is performed.) Is HCV-Lookback still required?Gary Tegtmeier, PhD, Community Blood Center of Kansas City, has provided the following response: The truth is that the "requirement " for HCV look back only exists as "FDA Draft Guidance for Industry, June 1999, Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV." It is unknown when the draft guidance will appear in its final form, but most blood centers and hospital blood banks are abiding by the guidance delineated in the draft. There is no current FDA guidance dealing with management of NAT-positive donors and their donations. Reportedly, this guidance should appear imminently. Dr. Tegtmeier provides the following
guidance to the issue: Back to TopDoes a second ABORH type need to be performed on patient samples? Dr. Carole Hathaway from St. John's Mercer Hospital in St. Louis, MO has provided the following response: The current CAP checklist item TRM.30550 asks: Does the facility have a documented program to ensure that the risk of pretransfusion sample misidentification is monitored and subjected to continual process improvement? Some facilities may perform a second ABO group type on a sample obtained by a second phlebotomy. Performing this second type is one way to meet the requirement. However, this is not the only method. The checklist list offers other acceptable methods as well. Any process that will ensure proper sample identification and can be monitored to improve quality would fulfill the requirement. Note: Other methods listed include use of a mechanical barrier system, electronic sample labeling system, duplicate sampling of patients (or the transfusion of Group O red cells until this re-sampling is completed). Key to improvement of the transfusion process, however, is active monitoring of the frequency of a failure of patient and sample identification and continual efforts dedicated to improving the process.
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