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Cliff

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Posts posted by Cliff

    Barcoded label for split or pooled products

    in Transfusion Services

    Posted

    Hi Richard,

    Could you please clarify your position for us?

    Here is the FDA Federal Register link - http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm.

    Here is a brief excerpt:

    "SUMMARY: The Food and Drug Administration (FDA) is issuing a new rule

    to require certain human drug and biological product labels to have bar

    codes."

    "DATES: Effective Date: This rule is effective on April 26, 2004.

    Compliance Dates: Drug products that receive approval on or after

    the rule's effective date must comply with the bar code requirement

    within 60 days after the drug's approval date. Drug products that

    received approval before the final rule's effective date must comply

    with the bar code requirement within 2 years after the final rule's

    effective date."

    AABB's Association Bulletin 06-03 talks about the requirement for ISBT, I don't believe FDA will require ISBT 128.

    Association Bulletin 06-03 footnote excerpt:

    "As a separate matter, upcoming editions of AABB Standards will set forth requirements relating to ISBT 128 implementation. The 24th edition of Standards for Blood Banks and Transfusion Services (effective Nov. 1, 2006) will require that facilities have a written plan for the implementation of ISBT 128, and the 25th edition (effective May 1, 2008) will require implementation of ISBT 128 by accredited facilities. The 2nd edition of Standards for Cellular Therapy Product Services (effective March 1, 2007) will require that facilities have a written plan for the implementation of ISBT 128, and the 3rd edition of those standards (effective Sept. 1, 2008) will require implementation of ISBT 128. (For additional information regarding ISBT 128, see Association Bulletin #05-12.)"

    So, the way I read these is all products that leave the blood bank as of April 26, 2006 must have some type of bar code. It doesn't matter if you facility uses this information anywhere else. By November 1, 2006 we must have a plan to implement ISBT 128 in place. As of May 1, 2008 we must have implemented ISBT128. The dates are different for cellular therapies, please see above.

    Actually in April 2006 you only need plan to implement ISBT128 bar codes for all products. May 2008 all products brought to patients must be bar coded. You should talk with your LIS and/or Blood Baqnk software vendor. Almost all have interfaced with our ( Digi-Trax's Hema Trax.LPS ) on-demand ISBT128 compliance labeling software. We also have a stand-alone PC prodcut available for those that do not have LIS with this facility. You can get more information by visiting our web site: www.digi-trax.com and look at Blood Bank Software ( Hema Trax }:redface:

    Factor concentrate labeling (barcode?)

    in Transfusion Services

    Posted

    Fortunately for us, we issue it in the original box.

    Here is some info from the latest AABB Bulleting (06-03).

    Background – Application of Bar Coding Regulation

    FDA responded to AABB’s inquiry for further clarification regarding the new bar coding regulation. FDA responses are provided below in italics.

    Does the regulation apply to plasma derivatives (e.g., clotting factors or Rh Immune Globulin)?

    Plasma derivatives such as antihemophilic factor, and immune globulins are not subject to the bar code labeling requirements in 21 CFR 606.121©(13), but they are subject to the requirements specified in 21 CFR 610.67.

    Note: 21 CFR 610.67 defers to 21 CFR 201.25 for some products.

    Labeling irradiated units

    in Education / Quality

    Posted

    OK, so I just read an Ask the FDA from last years AABB meeting.

    Question:

    A facility imports a licensed red cell and irradiates it. (The facility is licensed to irradiate.) Does the importing facility place their license label on the irradiated product?

    Orton:

    If the product is going to be used internally, no, the licensing number of the irradiating facility does not need to go on it. However, if it is being shipped, the labels should have the original collector’s license number and registration, and the irradiating facility would have an additional label stating that the component was irradiated by the facility, and have the facility’s name, the license number and registration number on it.

    (Reference - AABB Regulatory Update–Ask the FDA– January 2006)

    It looks like we should not be crossing out the license of the original facility.

    One more 5 day plasma question.

    in Transfusion Services

    Posted

    Here is what we have in our SOP for returning products:

    a. Red cell products must be returned to the Blood Bank within 30 minutes or they must be returned in a cooler with an acceptable temperature indicator.

    b. Thawed fresh frozen plasma is acceptable for reissue if returned within 30 minutes or it must be returned in a cooler with an acceptable temperature indicator. Thawed fresh frozen plasma returned after 30 minutes of issue must have their expiration time changed to 6 hours from the time thawed.

    c. Platelets must be returned within one hour.

    d. Cryoprecipitate and Granulocytes are acceptable upon return until expiration.

    Coolers - Transport or Storage?

    in Transfusion Services

    Posted

    When we performed our validations, we did them with empty coolers. If we place two dummy bags filled with 10% glycerol, then they validate just fine!

    When we issue the coolers they always have a dummy bag with a temp indicator, and at least one unit of blood. So this is our process.

    Apparently the blood acts as a temperature buffer.

    Validating washed platelets

    in Transfusion Services

    Posted

    Currently when we wash adult platelets we resuspend them in normosol/dextrose and NICU platelets in albumin.

    Why? Don't ask. :D It's the way it's been done forever.

    We are considering switching resuspending all platelets in saline.

    Has anyone made this switch, and if you did, was it validated? If so, please share how you validated the process.

    Thanks

    Quarantine locations for products

    in Transfusion Services

    Posted

    We have many refrigerators and freezers.

    We have the luxury of having separate refrigerators and freezers for products that are in quarantine.

    The one we have for frozen RBCs and plasma products is a small under the counter style - we have constant trouble with this unit.

    If (when) this freezer fails and we discard it, we are considering storing our quarantine products in an existing freezer on a separate shelf.

    I am not aware of any rule that requires us to have a separate refrigerator or freezer, am I correct in this?

    Thanks

    Patient transported autologous blood

    in Donor Services and Donor Recruitment

    Posted

    Hi all,

    We are located in Boston, MA and have a patient who will be donating two units of autologous blood at Canadian Blood Services (CBS). The patient lives in Canada, and will be having surgery with us.

    CBS is asking the patient to carry the blood from them (CBS) to us when she travels here for surgery.

    The patient is requesting a letter to present to US Customs so she will be able to bring the blood into the US.

    I went to the US Customs site and emailed them asking what they would require on such a letter, but am still waiting for a response.

    Does anyone have experience with this?

    Thanks

    Records Retention

    in Education / Quality

    Posted

    We too keep all of our paper records indefinitely. Currently have a home grown system, and do not purge records. We are moving to Mediware this year, I doubt we will purge from that either. Once we move to Mediware we'll have fewer paper records, as we don't currently have direct entry or electronic crossmatch. We are a large facility.

    Coolers - Transport or Storage?

    in Transfusion Services

    Posted

    Kate,

    I agree with you, that's why we've been doing it this way for all these years; however, the January 2006 AABB Assessor Newsletter contradicts us.

    In the "Ask the FDA" session that was featured at the 2005 Annual Meeting in Seattle, the FDA representatives clarified issues of interests. One interesting topic was the FDAs stance on temporary storage temperatures vs. transport temperatures. The 21 CFR 600.15(a) refers to shipment and states that blood being transported (e.g. hospital to hospital) should be maintained between 1˚C - 10˚C. However, blood being stored in a temporary location or in a temporary vehicle (i.e. cooler) for the intent, or the potential intent of storage should be stored at 1˚C - 6˚C (e.g. use of a cooler to take blood to the operating room because there is no refrigerator is considered temporary storage).

    Sars

    in Donor Services and Donor Recruitment

    Posted

    Still wondering about this. It looks like FDA has not changed their stance. I know it's only a few less questions, but...

    Does anyone know if FDA is considering lifting this?

    Are you still asking questions proposed by AABB related to SARS?

    • In the past 28 days, have you been ill with SARS or suspected SARS?
    • In the past 14 days, have you cared for, lived with, or had direct contact with body fluids of a person with SARS or suspected SARS?
    • In the past 14 days, have you traveled to, traveled through, or resided in areas affected by SARS?
    I see in the proposed AABB questionnaire (http://www.aabb.org/Content/Donate_Blood/Donor_History_Questionnaire/dhq.htm) that these questions are no longer present.

    FDA has not had any updates sine 2003 (http://www.fda.gov/cber/gdlns/sarsbldgd.htm)

    Coolers - Transport or Storage?

    in Transfusion Services

    Posted

    Problem is the time at which the units stay at or below 6 C. We could get 4 hrs at or below 10 C, but only 1 hr below 6 C.

    Bummer ....

    We have the same problem, we can get them (Igloo) to validate under 10 for at least 8 hours, but under 6 is about 1-2 hours, and some won't do even that good.

    We still have a few "old" blood coolers in the lab, unfortunately we don't have the ice blocks for them. They are large with an orange lid and hold at least 6 units. They have an insulated cover that is sealed when closed.

    We are looking for a similar type cooler, one with an insulated cover that actually holds the temp. Does anyone know of a vendor for these?

    Coolers - Transport or Storage?

    in Transfusion Services

    Posted

    AABB and FDA clearly define the storage (1-6 C) and transport (1-10 C) temperatures for blood products. We have many (30+) coolers that we have validated can hold a temperature between 1-10 C. Most of them will not reach a temperature below 6, and those that do usually only hold it for a couple of hours.

    Previously we had considered these products to be in transport; however, I will agree it is more appropriate to consider them often being used for storage, especially in the OR when they may remain there for many hours.

    Does anyone have a cooler they have been able to validate that maintains a temperature of 1-6 C?

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