Processes and Software Building 26: Donor Collection 4

Deferral Intervals for Each Donation Type

Donation can be whole blood or apheresis-based.  The sex and age for each donation type is specified.  At HMC, we did not accept females for platelet or plasma donations, so the starting age is listed as 99 years.  Otherwise, in accordance with Qatari law, the starting age for donation is 18.  All these parameters are user-definable, and a transfusion medicine physician can override the rules if necessary.

For each and every combination of donations, the deferral interval must be specified.  Examples follow.  The temporary deferral period is in days:

Previous donation whole blood, current donation whole blood:  56

Previous donor platelets, current donation whole blood:  2

Previous donation whole blood, current donation platelets:  56

Also note how for each possible combination there is an entry for male AND female.  Females are restricted to whole blood donation and only RBCs will be made from the collection.

If there is a collection incident and the apheresis procedure is not completed, the interval will be set to 56 days.  This will be covered in the post on donor adverse effect reporting.

To Be Continued:

3/8/20

Processes and Software Building 25–Donor Collection 3

Donation Type and Bag Parameters

At the time of registration, the type of donation must be specified.  In my last position, this could include whole blood for automated Reveos, whole blood for cryoprecipitate, plasmapheresis, COVID 19 convalescent plasmapheresis, plateletpheresis, concurrent platelet and plasmapheresis, concurrent platelet, plasma, and RBC apheresis, RBC apheresis-one unit, and RBC apheresis-2 units.

There is also a specimen-only donation without actual collection that includes database check, assignment of an ISBT specimen number, donor questionnaire, physical examination, and specimen collection only..

We specified which bag or kit could be used for each type of donation so when it was selected, only that bag type would be accepted by Medinfo

For each of these types we must specify what type of donation is permitted:  volunteer, autologous, or directed.

Finally, we must indicate the maximum length of the procedure permitted.  This applied to whole blood only and we set this at 15 minutes—this is user definable.

The following are a sample set of parameter settings for the above:

Note how we included contingencies for old bag sets and equipment (that we later discontinued) and for granulocyte collection (which we did not actually perform).

To Be Continued:

1/8/20

Processes and Software Building 23: Donor Collection 2

Building the Software Processes for the Donor Center 2:

Donor Collection and Screening—Registration and Pre-Donation Parameters

The potential donor enters the collection area.  He takes a number and waits to be called.  When called, he shows a picture identification card with a unique alphanumeric sequence.  This is entered into the donor module software and the system checks the donor deferral database for temporary and/or permanent contraindications.  If none are found, a consent form with an ISBT specimen number is generated.

In this post, we will consider:

  1. Registration process in multiple languages
  2. Donor deferral database
  3. Donor consent with generated unique ISBT specimen number
  4. Registration Parameters

Registration:

In the Middle Eastern region, multiple languages are used.  Although Arabic may be the main language, not all the registration staff may speak it.  English is commonly used as the main work language.  The date may be entered as Common Era (Gregorian) and/or Hijri.

An issue is that for native Arabs, the only precise, unambiguous name spelling is in Arabic.  English transliterations vary.  Example, Muhammad in Arabic is very simple to write, in English it may be rendered as Mohamed, Mohammed, Muhammad, etc.  The donor’s name should be recorded exactly as in his native alphabet.  How do you register when the staff do not speak or type Arabic?

Fortunately, I have worked with software that is in UNICODE, meaning that the data does not have to be restricted to English or Latin script (I wonder why the hospital information system we had at one institution could be sold in the Middle East and not have this capability!).  That means one could perform registration and donor questionnaire tasks in multiple languages, and preferable the native language of the donor.  One could even prepare database reports in Arabic.

Medinfo had an elegant solution to the registration process in Qatar.  It read the local identity card’s barcode issued by the Ministry of Interior and accessed (read-only) the demographic data on that donor and received back both the English and Arabic name fields:

This would generate the demographic fields in the registration:

The blood bank software would check the national donor deferral database and list any deferrals/contraindications to donation and the next eligibility date.  It would also list what type of donations were permitted (e.g. for females, only RBCs could be collected and processed:  if a whole blood unit was collected, then the platelets and plasma would NOT be permitted to be processed and were discarded.)

Medinfo used a unique key field, the Medinfo Hematos Donor ID for the database.  This was not the same as the national ID card.  All records were indexed against this number with strong security.

Donor Deferral Database:

Medinfo had already imported donor data from a previous computer system and added this to its own database.  Thus, there was only one database to check.  The database listed all previous donations:  dates, type, status (complete, aborted).  Any contraindications would be prominently shown in RED.

Donor Consent and Assignment of Donor Unit (ISBT Specimen) Number:

If there were no contraindications, Medinfo generated a donor consent in English and Arabic and the unique donor unit number for the current encounter:


Registration Parameters:

Medinfo enforced registration according to the format of the identity card.  The donor ID format was built into Medinfo.  If the entry deviated from this, it was rejected and registration could not continue:

The registration type would be selected (volunteer, autologous, directed, or paid).  In Qatar, paid donations were not permitted:

Next, the donation type had to be selected:

At the time of registration, the type of collection bag (or kit if using Reveos) was automatically set in Medinfo.  I will consider this further in the next post of this series to determine eligibility based on the previous donation interval and type.

At each donation site, the allowable types of donations and kits could be set.  Based on the donation parameters above, staff could not select the wrong type of bag/kit (e.g. an apheresis kit for a mobile donation).

To Be Continued:

30/7/20

Processes and Software Building 22: Donor Collection 1: Current and Future States

This is a first is a series of detailed posts of how I collaborated with Medinfo (Nice, France) to build customized donor software for both Saudi National Guard Health Services and Hamad Medical Corporation Doha.

In particular, we were using a non-turnkey software which could be built to order.  If we didn’t know what we were currently doing, how could we build something better?

At both sites, we had good manual systems in effect and prepared detailed mapping of the current state.  We reviewed our variance reports to see where we needed to bolster the system and improve the critical control points.

We studied the software options and prepared a draft Medinfo future state from which we started to build the system.  We did this in small stages so we could test it and adjust our settings as needed—without being charged extra (unlike a general laboratory software I had been working with at the same time, which always charged an arm and a leg).

To do this, I engaged early a team of my most computer-literate staff to work as Super Users.  In the Donor Center, this consisted of nurses and technologists.

To Be Continued:

27/7/20

Summary of Accomplishments at HMC 2011-2020

I resigned from HMC on 16/4/20.  Here are a set of my major accomplishments during that period. None of my work after this date has any relationship to HMC.

2011

Established automated component production using Atreus technology, plasma and platelet pathogen inactivation (Mirasol)—made HMC component production Good Manufacturing System GMP compliant

Adopted non-PCR-based NAT technology (Grifols/Novartis Tigress) and Qatar becomes world reference site for this

Based on the above, Qatar can now completely process all whole blood into blood components (red cells, platelets, and plasma) in as little as 5 hours from collection!

2011-2020:

Prepared policies and procedures for the hospital blood banks/transfusion services, blood donor center, therapeutic apheresis, and laboratory information systems to bring HMC in compliance with the Council of Europe, international AABB, and other standards.  I customized our own standards for our local needs based on them.

2012-2013

Implemented custom build of the multilingual blood bank computer system (Medinfo) for both patient and donor services, including development of interfaces to all production equipment including Atreus and Mirasol (world’s first) and a direct link to Ministry of the Interior to obtain patient demographics in English and Arabic—Qatar became the world’s first site to combine fully-interfaced, automated component production with pathogen inactivation:  Qatar becomes world reference site for this.

2013-2014

Built, validated, and implemented laboratory build of hospital information system, Cerner Millennium

2015

Replaced and updated Atreus with Reveos automated component production to allow faster throughput and capacity with a full bidirectional interface (world’s first), introduced platelet-additive solution PAS with pathogen inactivation (Mirasol)—Medinfo interfaces updated to Reveos for all equipment:  this doubles the capacity to process whole blood into components using the same physical space

2015-2019

Updated dedicated blood bank software Medinfo Hematos IIG by several versions using Division Head, LIS, and internally trained Super Users—at great cost savings to HMC by not using outside consultants (e.g. Dell Consulting)

2019

Established column absorption technology using Terumo Optia therapeutic apheresis machine for treatment of ABO-incompatible renal transplants:  I validated using the Ortho Vision MAX to perform ABO antibody titers for this system and correlated it with the reference method at Karolinska Institutet in Stockholm (manual gel) to bring rapid throughput and labor savings—Qatar being the first-site in the world to do this.  We saved money by using the same apheresis machine to use this column absorption technology (no need for second machine to use the columns)

2020

Expedited setup (two weeks total) of COVID-19 convalescent plasma production, initially manual and then fully integrated into the Medinfo computer system as a customized module with separate quarantine collection, production, and transfusion service functions

Other:

I was awarded two HMC Star of Excellence Awards:

2013—Liver Transplantation Transfusion Support

2019—ABO-Incompatible Renal Transplantation Support

TRALI/TACO Policy and Process

The following was my process at HMC Doha for TRALI/TACO.  It includes proactive measures to minimize the risk of TACO and the procedure for surveillance and workup of such cases.

In the Medinfo blood bank computer system, we did not prepare plasma or platelets from female donors.  If approved by a transfusion medicine physician, a manual override was made in exceptional cases (e.g. mother donating platelets for her child in neonatal alloimmune thrombocytopenia cases.).  In some other countries, they do HLA antibody testing to allow females to donate platelets.

I emphasize that the diagnosis of TRALI and/or TACO is clinical, but the transfusion medicine physicians must always consider the possibility whenever there is an adverse effect associated with progressive respiratory distress.

Principle:

Since TACO and TRALI are major causes of serious adverse effects from transfusions, this policy outlines actions being pro-actively taken to mitigate the risks in Transfusion Medicine.  TACO and TRALI may be difficult to distinguish so this policy addresses both.

Objectives:

  1. Implement measures to minimize TRALI and TACO
  2. Track cases of transfusion-associated acute lung injury TRALI and TACO
  3. Develop algorithms for suspected cases of TRALI and TACO

Tracking:

  1. All transfusion reactions are reviewed by the Division Head, Transfusion Medicine or his designee on a STAT basis, 24 hours a day, 7 days a week
  2. Any reactions with respiratory distress are reported as “rule-out TRALI/TAC” to the clinician
  3. All transfusion reactions are recorded in Medinfo HIIG for tracking and reporting.

Risk Management:

  1. Female blood donors routinely are only used for making RBC components (i.e. not for FFP, cryoprecipitate, or platelets).
  2. RBCs are in additive solution SAGM so only 35 ml residual plasma is present per unit.
  3. All platelet components are in platelet additive solution with only 35 ml residual plasma per component.
  4. All platelets and plasma are pathogen-inactivated which may reduce the risk of TRALI.
  5. If the female has a rare phenotype (e.g. IgA deficient, rare platelet antigen typing) she will only be considered for a directed donation of platelets or FFP/cryoprecipitate for that special-needs patient if she does not have HLA antibodies (anti-human-neutrophil antibody testing to be implemented in such cases when it is available on-site).
  6. Solvent-detergent treated plasma SDP is available for patients with a confirmed or suspected history of TRALI.
  7. All cellular components are leukodepleted (< 1E6 residual WBCs/component as per CE Standards) in the blood bank at the time of production.
  8. Blood bank computer system Medinfo Hematos IIG limits the number of components released at any one time (excluding emergencies).

Notifications:

  1. Transfusion Medicine TM will notify the outside blood supplier of any units implicated or associated with TRALI.
  2. A transfusion medicine physician will notify the most responsible physician of any workup results suggesting the possibility of TRALI/TACO.
  3. TM will notify all donors of their disqualification from blood donation based on the following algorithm.

Algorithm for Diagnosis and Management of Donors:

  1. Evaluation of the Donor and Recipient in Suspected TRALI:
    1. The medical technologist will process all transfusion reactions as STAT and immediately contact the TMS Director or physician designate with the results.
    2. The medical technologist will convey information to the TMS Director or designate about ALL blood components issued recently, especially in the last 6 hours prior to the event.
    3. The TMS Director or designate will specifically check if there is evidence of respiratory distress listed on the transfusion reaction investigation form.  If so, he will contact the responsible clinician immediately for further assessment.
    4. If the signs and symptoms suggest ALI (see Table 1 above), the TMS Director or designate will inquiry about the left atrial pressure to rule out left-sided heart failure as a cause for the pulmonary edema.
    5. Based on the clinical information, the TMS Director or designate may elect to order any or all of the following tests if available:
      1. Quarantine all remaining components from possibly implicated/associated donor(s) while the workup is in progress.
      2. Recipient HLA, platelet, and/or granulocyte antibody screen, or a crossmatch between recipient plasma/serum and donor leukocytes
      3. Donor HLA and/or platelet antibody screen, granulocyte antibody screen, crossmatch donor plasma/serum and recipient leukocytes, inter-donor crossmatch between plasma/serum of one and leukocytes of another donor.
      4. The usual algorithm to be followed is as follows:
        1. Consult patient medical record and clinical care physician to determine if the diagnosis of TRALI is likely.
        2. Check all components transfused within 6 hours prior to the onset of symptoms.’
        3. Immediately quarantine other components from the same donations and contact outside blood suppliers if indicated.
        4. Obtain donor antibody testing of only highly suspect cases, based on the clinical manifestation and initial diagnostic tests:
          1. If multiple units transfused within hours, only investigate components donated by multiparous females and/or last two units transfused.
          2. First test for presence of HLA class I and class II antibodies in donor components.
          3. If antibody positive, HLA type recipient’s lymphocytes to detect corresponding antigen or perform crossmatch with donor plasma and recipient lymphocytes.
          4. If HLA antibody negative, proceed with neutrophil-specific antibody testing of donor plasma.
        5. If matching antigen-antibody identified or if positive crossmatch, defer implicated donor immediately.
        6. If no such concordance found or if crossmatch is negative, donor eligible to continue donating.
        7. If no antibodies found in donor plasma, test recipient plasma for antibodies to HLA class I and II antigens:
          1. If recipient antibody positive, HLA type donor’s lymphocytes to detect corresponding antigen or perform crossmatch with recipient plasma and donor lymphocytes.
          2. If recipient HLA antibody negative, proceed with neutrophil-specific antibody testing of recipient plasma
  2. Donor Disposition:
    1. For donors implicated in TRALI or associated with multiple events of TRALI, one or more of the following options may be selected at the discretion of the Head, Transfusion Medicine or designate:
      1. Defer donor from donation
      2. Divert plasma for fractionation or discard plasma from future whole blood donations from that Blood and Apheresis Donor Main Questionnaire
      3. Manufacture no platelet or plasma components from that donor
      4. Wash or freeze/deglycerolize RBCs from that donor
      5. Permanently defer the donor from future plasmapheresis or plateletpheresis donations
      6. Evaluate the previous donations from that Blood and Apheresis Donor Main Questionnaire  Avoid giving the same recipient future transfusions from the same donor implicated in TRALI
      7. If the implicated unit(s) are from another facility, that blood center should be notified to initiate a workup for possible TRALI in the donor.
  3. Interpretation:
    1. The diagnosis of TRALI is not clear-cut:
      1. The AABB interim standard does not apply.  It is at the discretion of the TMS Director or designate whether to conduct donor assessments.
    2. The donor is associated with a single event of TRALI:
      1. This applies where the diagnosis of TRALI has been established based on clinical and radiographic findings:
      2. Each donor from each and every component associated with TRALI must be identified and traced.
      3. Co-components from the current donation and components from previous donations should be evaluated for recipient complications.
      4. The donors medical history should be evaluated for previous pregnancies, transfusions or other events that may have resulted in antibody development.
      5. Based on the results of this investigation, the Head, Transfusion Medicine or designate should decide:
        1. Whether to perform laboratory testing
        2. Whether to discard the remaining blood components from the donor
        3. Whether to allow or indefinitely defer the donor
    3. The donor is associated with multiple events of TRALI:
      1. This applies where the diagnosis of TRALI has been established based on clinical and radiographic findings:
      2. Each donor from each and every component associated with TRALI must be identified and traced.
      3. Co-components from the current donation and components from previous donations should be evaluated for recipient complications.
      4. The donors medical history should be evaluated for previous pregnancies, transfusions or other events that may have resulted in antibody development.
      5. Based on the results of this investigation, the TMS Director or designate should decide:
        1. Whether to perform laboratory testing
        2. Whether to discard the remaining blood components from the donor
        3. Whether to allow or indefinitely defer the donor
    4. Triage based on laboratory testing for TRALI:
      1. The donor associated with TRALI is antibody-negative:
        1. The donor may continue to donate.
      2. The donor associated with TRALI is antibody-positive but the specificity is NOT directed against a recipient antigen by either antigen typing or crossmatching (i.e. the donor is NOT implicated in TRALI—see definition above):
        1. Indefinitely defer the donor from all donations OR
        2. Allow donation of washed/frozen-deglycerolized RBCs only
      3. The donor is implicated in TRALI (see definition above):
        1. Indefinitely defer the donor from all donations OR
        2. Allow donation of washed/frozen-deglycerolized RBCs only
      4. The recipient has antibodies implicated in TRALI (determined by crossmatch or antibodies directed against specific HLA class I, HLA class 2, and/or human neutrophil antigens):
        1. The recipient must receive leukodepleted blood components
    5. TACO
      1. TACO is due to cardiac overload.  Our mitigations are to restrict release of the number of components outside emergency events.

References:

  1. AABB Association Bulletin 14-02, TRALI, Bethesda, MD, USA
  2. Han Y. and Goldfinger D., Transfusion Medicine TM 07-5 (TM-297) Checksample, American Society for Clinical Pathology, Chicago, IL, USA. July 2007
  3. Goldman M, Webert, KE, Arnold DM, et al., Transfusion Med Rev  2005; 19:2-31.
  4. Fung YL, Goodison KA, Wong JK, Minchinton RM., Investigating Transfusion-Related Acute Lung Injury (TRALI), Intern Med J. 2003 Jul;33(7):286-90.
  5. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  6. AABB Association Bulletin #05-09, Transfusion-Associated Acute Lung Injury, 11/8/05
  7. AABB Association Bulletin #05-04, Proposed Interim Standard for Deferral of Donors Implicated in TRALI, 9/3/05.
  8. TRM.42110, CAP Transfusion Medicine Checklist, 15/6/09

Zika Virus Donor Screening

Principle:

The flavivirus Zika virus can be transmitted through mosquito bites from Aedes aegypti and Aedes albopticus species.  The outbreaks have been associated with severe birth defects, especially CNS (microcephaly).  Although it is not clear if it can be definitely transmitted by blood transfusion, major international organizations, UK National Health Service,  World Health Organization, and the American Red Cross have instituted temporary deferrals for travelers from those affected areas.

Change Log:

This bulletin reflects recommendations made by the FDA Bulletin dated 1/3/16, FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue.

Policy:

  1. Travel History:

As part of the usual screening questionnaire, donors must be asked if they have travelled to an affected area (refer to http://www.cdc.gov/zika/geo/index.html or http://wwwnc.cdc.gov/travel/page/zika-information).

  1. If so, then they are to be temporarily deferred from blood donation for 28 days upon leaving that area.
    1. A specific question about Zika travel history is now active in the Medinfo Hematos IIG questionnaire.
  2. Clinical Symptoms:
    1. Donors should be asked if they have now or within the past 28 days had any of the following symptoms:
      1. Fever
      2. Rash
      3. Joint Pain
      4. Conjunctivitis (red eyes)
      5. Muscle Pain
      6. Headache
    2. If a donor has any of the above symptoms, they should be deferred for 28 days from blood donation after visiting the Blood Donor Center.
  3. Sexual History:
    1. Blood donors should be deferred for 28 days after the last sexual contact with a man who has been diagnosed with Zika virus or who traveled to or resided in an area with active transmission of Zika virus in the 3 months prior to that instance of sexual contact.
  4. Re-entry of blood donor after deferral:
    1. Defer for 4 weeks after the resolution of symptoms a donor with a history of Zika virus infection.
    2. A deferred donor may be considered eligible after the deferral period has lapsed provided that all donor eligibility criteria are met.
  5. Cellular product and other tissue donors:
    1. Living Donors of Cellular and Tissues:  Donors should be considered ineligible if they were diagnosed with Zika virus infection, were in an area of active Zika virus transmission, or had sex with a male with either of those risk factors within the past SIX (6) months.
    2. Donors of umbilical  cord, placenta, or other gestational tissues should be considered ineligible if they have any of the above risk factors at any point in their pregnancy
    3. Deceased (non-heart beating) donors:  Donors should be considered ineligible if they were diagnosed with Zika virus infection within the past SIX (6) months

References:

  1. Center for Biologics Evaluation and Research CBER Guidance for Industry Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus, February 2016
  2. AABB Association Bulletin #16-03 Zika, Dengue, and Chikungunya Viruses,
  3. Blood Banks Establish Waiting Period For Prospective Donors Returning From Zika-Affected Areas, AABB Newsbrief, 4/2/16
  4. FDA Bulletin 1/3/16, FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue.
  5. Zika travel information. Centers for Disease Control and Prevention website. http://wwwnc.cdc.gov/travel/page/zika-travel-information, 16/2/16
  6. U.S. CDC Issues Zika Travel Advisory for 11 Southeast Asian Countries, Medscape, 1/10/16

Prepared By:

Zeyd Merenkov, MD, FCAP, FASCP

Senior Consultant/Head, Transfusion Medicine/LIS

Processes and Software Building 9: Enforcing GMP

Enforcing Good Manufacturing Process Through A Dedicated Blood Bank Software

Blood components are a drug and like medications must be consistently produced and follow Good Manufacturing Practices GMP.  The following system that I set up for HMC Doha Qatar blood collection and processing is an example of the impact of Medinfo donor software on enhancing our safety and GMP compliance.  In earlier posts, I provided the Medinfo flowcharts for these processes.

This is an outline of the processes I built in conjunction with the Medinfo software engineers:

  1. Registration:
    1. Read the barcode on the specified picture ID (usually a Qatar Residency/Citizen card).
      1. Retrieve the prospective donor’s demographics in English and Arabic from the Ministry of Interior.
      2. Check the donor deferral database (Qatar has only one), defer if contraindicated according to the rules built into Medinfo.
    2. Choose the type of donation (apheresis or whole blood;  volunteer, directed, or autologous).
    3. Print a consent form and ISBT specimen labels for the donation.
  2. Pre-Collection Screening:
    1. Perform the donor questionnaire on-line in English or Arabic:  this has contingent fields and could exceed 60 questions depending on the answers provided.
    2. Proceed to donor physical exam (vital signs and arm check).
  3. Collection:
    1. Collect the whole blood or apheresis component and specimen tubes:  determine if the collection meets the volume requirement and time limit.
    2. Send the specimens for donor marker and donor immunohematology testing.
    3. Send the raw components for processing.
  4. Donor Marker Testing:
    1. Perform NAT, EIA, and LIA marker testing according to algorithms defined in Medinfo.
    2. Perform follow-up reflex marker testing according to Medinfo criteria.
  5. Component Processing:
    1. Process the raw whole blood in the Reveos machine into PRBCs, leukodepleted plasma, and buffy coat platelets.
    2. Filter/leukodeplete the RBCs.
    3. If marker test results pass:
      1. Pool the buffy coat platelets according to the platelet yield index for a yield of 2.4E11/dose.
      2. Add platelet additive solution PAS and pathogen inactivate (Mirasol).
      3. Pathogen inactivate the whole-blood-derived plasma.
      4. Divide the apheresis plasma into 200-250 ml aliquots and pathogen inactivate.
    4. Divide the apheresis platelets to provide a yield of 2.4E11 in each dose, then pathogen-inactivate (PAS had been added at the time of the apheresis collection).
  6. Donor Immunohematology Testing:
    1. Perform ABO/D testing and antibody screen (identification if positive):
    2. If antibody screening positive, discard the component.
      1. If ABO discrepancy, send for manual review and approval, otherwise discard.
  7. Labelling, Storage, and Transfer:
    1. If all criteria were met, attach the final ISBT label (this can only be printed based on the acceptance of each component).
    2. Place the components into storage (37C, 1-6C, or <= minus 18C).
    3. Distribute to the hospital blood banks using Inter-Depot Transfer function.

I emphasize that only if all criteria across all areas pass is the final ISBT label printed.  Medinfo is not a label printing program.  It enforces the rules ruthlessly.  My technical staff tell me that it is merciless—as it should be for patient safety.

Attachments:  None—please refer to earlier posts regarding collection, processing, donor testing, and inter-depot transfer.

28/6/20

Inter-Depot Transfer: Further Thoughts

In my recent post, I provided sample flows and parameter mapping for delivery of blood components.  The final components from the component preparation center may be sent to various depots (freestanding location and/or hospital blood banks.  There should be complete traceability for every step (from donor reception, collection, testing, and processing) transport between locations, and finally the exact storage site, which might include which refrigerator/freezer/incubator and even shelf/position number for each component is stored.  The end of that document showed rules for type/antigen matching.

For disaster planning, rapid inventory enumeration by type is very important.  This can be very time-consuming manually.  With our Hematos blood bank system, we could quickly get total inventory across the Qatar or by hospital in less than one minute.  We could also quickly find antigen-matched units across the system and reserve it at any one site for another if necessary.

Smart blood bank dispensing refrigerators, as offered by Haemonetics and Angelatoni, may also serve as depots and take the place of a hospital blood bank for some dispensing.  These solutions can also capture vital information about the storage conditions of the components and prevent release if the storage criteria are not met.  They can also interface with blood bank computer systems and use the main system’s logic for the dispensation rules.

Upon receipt at the hospitals from the blood processing center, the forward ABO and D typing must be confirmed.  We used D reagents which detected partial D so that we would call such donor units as D-positive.  However, if a patient type reagent insensitive to partial D types were used, it is possible for a unit to be typed as D-negative whereas in the donor center it might be D-positive.  Sometimes, nothing types consistently as D-positive:  all you can say is that with a particular reagent and lot number, there is or isn’t reactivity.

The greatest complexity is for RBCs since potentially so many antigens exist.  Criteria for matching/ignoring certain antigens must be made.  Critically significant antibodies such as the Kell, Duffy, Kidd, and certain Rh (D and c) must be antigen matched.  A robust blood bank computer system can enforce these rules.

For other components, antigen/typing may be less important.  In fact, in most situations, any type of platelets can be given to anyone (except neonates).  Despite the potentially incompatible plasma, there is rarely significant hemolysis.  In fact, if pooling platelets without regard to blood types is done, a platelet transfusion is a common cause of a positive direct antiglobulin test DAT—something that is not clinically significant.  No one died of a positive DAT by itself for this reason.

Specific rules for compatible plasma types are important, but nowadays, low-titer group A plasma may be used like universal AB plasma.  The challenge is to be able to perform the ABO titration (specifically anti-B) quickly—titration can be a slow process, even with automated equipment.  A similar situation for low-titer, universal group O whole blood requires both anti-A and anti-B titration (I will return to this topic in a future post).

Overview: Inter-Depot Transfer and Allocation of Blood Components

While I was working in Qatar, this was the overall process for transfer and allocation of blood components. Once they were finally labelled (only possible if all criteria had been meet), they were transferred from the Blood Donor Center BDC to Hamad General Hospital Blood Bank, from which they were distributed to all hospital blood banks in Qatar. Similarly, units could be transferred between the various hospital blood banks.

One could track components as being in:

  1. BDC
  2. Transit BDC to HGHBB
  3. HGHBB inventory
  4. Transit HGHBB to another hospital blood bank
  5. Transit between any two hospital blood banks

An inventory manifest would be printed to show all transferred units.

For patient use, allocation rules applied which would determine if an electronic or a full antiglobulin-phase crossmatch could be used and whether specific antigen-matched components were required.

There were also separate rules for emergency release if the standard criteria could not be met.