Category: Administration

Administrative documents, not necessarily technical or medical

Blood Component Variances

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Principle:

AABB Standards requires that all variances are documented and investigated and corrective actions taken when necessary.  Any time a blood component is found to be defective (e.g. broken seal, leaking, discoloration, clots, etc.), mislabeled, or testing results incomplete or not documented,  the cause should be investigated by the Donor Center and reported back to the initiator of the report in writing.

Policy:

  1. All transfusion services must inspect all blood components upon receipt (e.g. for leakage, broken seals, improper temperature, clots, discoloration, gas, etc.).
  2. Labels must be compared to the consignment sheet for complete concordance.
  3. If units are found that are not listed or mislabeled, they must be reported in writing to the Donor Center and returned as-is for investigations.
    1. If the unit is leaking or broken, ensure standard/universal precautions are taking to minimize contact with the fluids.
    2. Damaged blood components must not be used.  Units with mislabelings or other discrepancies between the labels and the consignment sheets may be used when such errors are corrected and officially reported by the Donor Center.
  4. Use the standard incident (occurrence variance) report form (OVA) for each and every variance.
  5. The submitting location should keep a copy of the OVA and immediately forward the original to the Transfusion Quality Section.
  6. The Donor Center should investigate the variance and prepare a written investigative report and submit to the Division Head, Transfusion Medicine.
    1. Donor Center investigations should be completed within one calendar week.
  7. The Donor Center should forward a copy of the completed written investigation to the transfusion service which initiated the investigation.
  8. The copy of the investigation report should be attached to the OVA and kept at the local site.
  9. Transfusion Quality shall include these variances in its monthly reports.

References:

Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Bedside Monitoring of Transfusion

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Once the blood component has left the hospital blood bank, it should be directed transported to the patient’s bedside for immediate transfusion.

At the bedside, the transfusionist (usually a nurse or doctor) must verify the information on the blood component labels (both the ISBT and specific reservation one for the patient).  With a bedside device, this includes:

  1. Scan the patient armband for hospital number
  2. Scan ISBT label:
    1. ABO/D type and any other antigen typings
    2. Blood component type (RBCs, platelets, plasma, etc.)
    3. Expiration date/time of the component
  3. Verify Reservation Label (on back of unit)— centrally performed in blood bank computer system based on #1 and #2 above:
    1. Intended recipient name and hospital number
    2. Compatibility status (compatible, least-incompatible, etc.)
    3. Expiration date/time of the compatibility testing/crossmatch
  4. Record Documentation During Transfusion:
    1. Physical inspection of the unit
    2. Time stamp of transfusion start
    3. Vital signs before starting transfusion
    4. Periodic vital signs during transfusion
    5. Time stamp of stopping transfusion
    6. Any adverse effects during the transfusion
    7. Any adverse effects after the transfusion (remote vital signs, oxygen saturation, EKG lead—if appropriate monitoring device attached to patient (e.g. Umana T1 device).

All of these parameters can be entered into a hand-held device that transmits them to the blood bank computer system (e.g. Medinfo Hemotrace.)

The Blood bank computer system (patient module) should verify that this is the proper unit for the intended recipient and that the transfusion is starting within the reservation limit of the unit and serves to verify the information on the reservation label attached on the back of the blood unit.

With a device such as  the new Umana T1 device from the GPI group, the vital signs together with an EKG lead and oxygen saturation can be automatically uploaded into the handheld device that feeds into the blood bank computer system such as Medinfo Hematos IIG and/or directly transmitted to the blood bank software.  This device can continuously record this information for several days and detect post-transfusion adverse effects such as TRALI/TACO and delayed hemolytic transfusion reactions.

Note:

Some other nursing hand-held devices are available for recording patient data but many cannot read the ISBT unit number or descriptor information.  They also do not check with the blood bank computer system to check if the right unit of blood is being offered to the patient during the validity of the transfusion period (four hours after leaving the blood bank).

Opinion: Ready after Fellowship?

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I was recently interviewing a candidate for consultant in Transfusion Medicine.  Several months previously he had completed a fellowship in Transfusion Medicine in the United States.  He was applying for a position in my hospital in Qatar, which included seven hospitals and a blood donor center.  He had no training in donor management or therapeutic apheresis.

The successful candidate was to rotate on-call to cover all hospitals and the blood donor center.  He had never worked outside the United States.  Routinely, he did not review antibody panels since those workups were usually sent to the local blood provider there.  In his training, he had strictly followed US FDA and American version of AABB Standards.  His training center did not routinely do extended phenotypes (C, c, E, e, and Kell).  Extra testing and phenotyping had to be explicitly ordered by the clinician to get reimbursement.  Thus, there was no prophylactic antigen matching done on patients.  He did not feel comfortable reviewing antibody panels.

He had no experience with universal leukodepletion, pathogen-inactivation, platelet additive solutions, or automated component production such as the Terumo BCT Reveos.  He did not interpret donor marker testing results.

On the contrary in our organization, the transfusion medicine physician had to review all antibody panels (usually he was the most knowledgeable person for this).  We followed the Council of Europe CE and other practices that did prophylactic antigen matching.  We were also in charge of donor qualification and therapeutic apheresis and reviewed any product deviations from the Reveos and donor marker testing.

Clearly, this candidate did not practice transfusion medicine in the way that was necessary for our operations.  We could not cut him loose and make him responsible for a hospital transfusion service or the blood donor center.

Let us contrast this candidate for one being recruited for anatomic pathology/histopathology.  Grossing specimens, performing frozen sections, reading slides, diagnosing cases are the same everywhere in the world.  After completing his American certification, he could perform his profession almost anywhere in the world.

Transfusion medicine practices need to be localized and the selection of blood components and donor qualification are different.  Most of the world does not follow US FDA and has access to blood components, tests, and other technology that is different and maybe more advanced than his training in the USA.

I gave him a clinical scenario to interpret.  An AB patient with anti-K needs to be transfused with plasma.  Are there any special requirements for the plasma?  What if the only AB donor had anti-K would you use it?  What if the only RBCs available had not been phenotyped for Kell?  What would you do?

He did not know that we discard plasma with clinically significant alloantibodies routinely.  He did not want to phenotype the RBC unit for this patient since this had not been explicitly ordered by the clinician.

My recommendation was not to hire this candidate if there were others who had worked in European or similar systems to our own practices.  In effect, to use this physician, he would have to undergo a mini-fellowship to learn our practices since they were contrary to ours.  Unfortunately, we were very short-staffed and did not have resources to offer this training.

In summary, blood bank practices are very localized.  If you are considering to hire staff from other countries not following your standards, you must assess if the candidate is flexible to change his practices and/or whether you have the resources to train the physician.

Opinion: Laboratory Software Issues from Hell

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In my career, I have dealt with many different laboratory software vendors.  Regretfully, not all encounters have been straight-forward.  Since ultimately these products are used for patient care, I had hoped that there would be a sacred trust to do what is best.

Things that bother me:

  1. Current state:  whoever prepared it for the client, didn’t care or understand the local processes and came up with a generic:  Order it, collect it, receive it, do it, report it for each and every test.
  2. No training for super users:  more like lambs being led to the slaughter.  They will obey the vendor out of fear of making a mistake.
  3. No discussion of options:  pushing us to take the default setting—not even offering the available options.  The only way you find out there are available options is because other staff have used the same software at other institutions which used these options.
  4. Corrections to build:  only giving one shot to do it right, further corrections cost $$
  5. Scenarios:  vendor shows specially crafted scenarios that “work” but when you ask the vendor to do a random, non-scripted scenario, it crashes.
  6. Scalability:  limited scalability on client’s chosen platform.  That may force a rebuilding of the software when the limit is reached.
  7. Reference site does not match the test volume or activities of the client, uses different platform, and thus you cannot make a valid assessment.
  8. Performance issues:  if you don’t know why the system is slow, you can add more hardware (RAM, disk space, etc.) and try again—it can’t be due to the software design!
  9. Handling of requests:  does not permit your local IT staff to make changes, must send it back to the vendor for $$
  10. Waiting until hell freezes over:  will we get the corrected/updated package during this reincarnation?
  11. Interfaces:  an acceptable communication link is when one side speaks Sanskrit and the other Algonquin and they both hear each other, but who cares if they understand?
  12. Waiting for Godot:  God forbid if your equipment needs an interface not currently available:  how many cycles of the big bang can you wait?
  13. Champions or Heroes:  make a class of users who are to be evangelists for the new system and have them undergo sensitivity training including actions that are culturally irrelevant.  Don’t tailor it to local sensitivities or customs.  Will this convince the staff how useful the software is?
  14. Relevance of vendor experts:  Assume everyone understands what maple syrup is or comes from Kansas.  The expert assumes everyone has the same background as his/hers.  Who in the Middle East has seen maple syrup being made?  How can that analogy be useful for building software?
  15. Describe all reference units in feet/pounds/inches/furlongs/fortnights—no metric.  Do not use SI.
  16. Mix 24-hour clock with 12-hour clock:  what does 12:00 mean?  How do you measure time intervals?
  17. Consulting companies:  They are supposed to assist the client with the settings, but do they have the client’s best interests at heart?  Some are good spin-doctors and transfer blame to the client’s software staff when it is really their responsibility for the build.
  18. Rush, rush, rush:  Administrative powers who just want everything done quickly whether or not it is correct or validated properly, who cares if the processes built are right?

International Perspective

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When I first moved overseas from the United States, I brought the perspective of my American training and experience.  I saw everything in my new blood bank through those eyes.

Yet, most of my staff were not American or even North American.  Few were even native in English, and most of those  were not American.  They had different qualifications, many of which would not have been accepted by the American schemes.  Still, they functioned well.

I also worked with the US military technologist staff during Gulf War One.  Some did not even have a Bachelor’s degree;  yet, they performed the work well.

I used many technologies that were not yet (or never) US FDA approved such as gel or glass bead typings and pooled buffy coat platelet production.  There were rare reagents I could buy off the shelf (e.g. anti-Tja/PP1Pk).

Later, I adopted pathogen-reduction technology (Mirasol), automated component production (Atreus then Reveos), and platelet additive solution.  I achieve a level of good manufacturing practice that would have been difficult to achieve by the FDA-approved methods.

My perspective had changed.  In the Middle East, I studied many frameworks and came to the conclusion that the best approach was to customize them to our local needs.  My particular experience was to start with one framework, i.e. Council of Europe CE, and then localize it.

To do this, I could not use an American turnkey blood bank software for either the donor or patient operations.  I needed a flexible system that could be customized to my needs.  Again, I chose a CE-marked system, Medinfo Hematos IIG that had already been adapted to many frameworks.

It is much easier to work solely within one system such as FDA.  However, if I had done that, I would have lost so much flexibility and not had a system optimized for local conditions.  I would not have used Mirasol, Reveos, Diamed, and many other reagents.

One big disappointment at such international meetings is the perspective by one country’s regulatory agency that they feel its regulations and framework will work well overseas.  I would wager that those people were not well acquainted with international conditions.

Another frustration was attending another international meeting in which the presenters apologized for the source of information since it came from a foreign country (France) and not their own (United States).

No country has a monopoly on what is best for everyone.  To share our experiences and compare is so valuable.  No one assume his way is the best.  In my career, I have had the richest experiences studying other perspectives and my organizations have benefited greatly from the exchange.  We can all learn from each other.  We are citizens of the world.

Information to Collect Before Contacting the Transfusion Medicine Physician

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The Transfusion Medicine Physician needs certain minimal information to make a medical/clinical assessment and decide what action needs to be taken.

Policy:

  1. Before contacting the transfusion medicine physician, please obtain the following:
    1. Clinical diagnosis
    2. Transfusion history
    3. Medication history
  2. In the case of transfusion reactions, follow Interim Policy Transfusion Reaction Workup and be certain to include the following information before contacting:
    1. Vital signs (BP, pulse, temperature, respiratory rate) both pre- and post-transfusion
    2. Clinical symptoms (e.g. rash, urticaria, fever, respiratory distress, etc.)
    3. Pre-transfusion DAT if post-transfusion DAT is positive.
    4. Donor Unit DAT and eluate on the post-transfusion specimen if the post-transfusion DAT is positive and pre-transfusion negative.
    5. Eluate on the post-transfusion specimen if both the pre- and post-transfusion DAT are positive.

6/11/20

Opinion: Handling Incorrect Physician Orders

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Most of the non-transfusion-medicine physicians with whom I have worked have had only limited training in placing component or hospital blood bank orders.  In previous posts I have discussed this and suggested that all physicians who may possibly order blood bank tests or blood components should have a training and documented competence on a periodic basis.  Only a very few physicians, mainly hematologists and some organ transplant physicians, have placed reliable orders.

Before we had a blood bank computer system, we received orders on a manual paper requisition.  If there were errors, my technical staff and I corrected the order.  Any changes were made by me in my capacity as the blood bank medical director.  The ordering physicians and I had good relations and they had no problem with this—in fact, many were afraid of the blood bank and felt happy to be relieved of the responsibility.

In the current software era, what happens depends on how the order is placed.  Can the technical staff and I correct the order directly or must we each and every time contact the physician to revise his/her order?  Do my staff have to cancel each erroneous order and wait for the corrected order?  This could slow down the work process and prevent release of blood components in a timely manner.

Should the non-blood bank physician be allowed to order our complicated esoteric transfusion tests directly—e.g. ordering extended antigen typings or antibody identifications or elutions?   What if they order something unnecessary or inappropriate?

At a recent hospital position as Division Head of Transfusion Medicine, I discovered that the Hospital Information System HIS was very slow for all blood bank orders.  The physicians complained, I would allow them to bypass the HIS and use the manual backup system in critical situations.  If we had been forced to cancel the order and have the physician reorder, this would have greatly disrupted the work process.

We did not use the HIS at all in Transfusion Medicine.  We had patient and donor modules in the dedicated blood bank system Medinfo.  We had a limited ordering interface from the HIS to Medinfo for blood components and some basic testing (e.g. ABO/D typing, DAT, type and screen/group and save, cord blood testing, and transfusion reaction workups).  All work was done in the dedicated blood bank system.

All components were leukodepleted to < 1E6, all platelet and plasma were Mirasol pathogen-inactivated, all platelets were in platelet additive solution PAS.

The doctors did not order the specific blood component, rather they indicated a preference, e.g.

  • Packed RBCs
  • Platelets (adult dose of 2.4 E11)
  • Plasma
  • Cryoprecipitate

The following appeared as an order comment in the blood bank system:

  • The specific number or amount of the each component type
  • Preferences for pooled vs. apheresis platelets, washed RBCs, irradiated RBCs.

The blood bank staff could review the doctor’s request and order in Medinfo as per our internal protocols under my responsibility.  In effect, I was modifying the orders when needed just as I had done under our manual system.  This included type, modification, and quantity.  Yet now, I did not have to change any orders since the doctors had only indicated preferences.

For blood bank testing orders, we had our own internal algorithms for the workups.  The doctors could not order antibody identifications, elutions, or any antigen typings other than ABO/D.  They latter were triggered by the screening test results.

This system allowed us to avoid cancellations due to physician errors.  I was very comfortable taking the responsibility to alter the orders for best patient care.  If a physician did not agree with our algorithms, they could discuss the issue with one of the transfusion physicians, or ultimately appeal to me.  I was fortunate that there were no legal issues with this approach where I practiced.

In summary, my recommendations are:

  1. Have the doctors order a preference for the type of blood component.  They still order the quantity and can request modifications such as washing or irradiating or apheresis-derived or buffy coat pool platelets.  The actual allocation is made by blood bank staff under my direction.
  2. Offer algorithmic based testing.  Doctors only order basic testing which triggers reflex algorithms.  Most of the test menu is not orderable directly by the physicians (example:  an antibody identification is triggered by a non-negative antibody screen.

9/12/20

Release of COVID-19 Convalescent Plasma CCP

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Principle:

Testing, allocation, release, and transfusion of this special plasma will be similar to normal blood components except that the storage, modification, and release will handled at special quarantine location(s).  Release and modification of components is to be handled separately from the regular hospital blood bank/transfusion service.

Abbreviations:

CCP:  COVID-19 convalescent plasma

ID:  Infectious Disease Department (clinical COVID19 treatment unit)

QHBBB:  Quarantine hospital blood bank (which stores, thaws, and releases CCP)

Policy:

  1. Any potential recipient for CCP must have a CURRENT type and screen test (< 72 hours old.)
    1. A repeat type and screen should be ordered every 3 days during the time that CCP may be used.
  2. All CCP orders must be submitted to the ID senior consultant for triage.
  3. If the order is accepted by that authority, then an order and a doctor’s prescription for CCP must be both prepared and submitted to the QHBB.
  4. QHBB will allocate ABO-compatible CCP units and attached blood bank computer-generated release labels and forms to it.
  5. Designated ward staff will pick-up the CCP at the QHBB.
  6. Allow 1 hour for the plasma to be thawed.
  7. Only order when the transfusion is scheduled—1 hour before the intended transfusion date/time.
    1. Sign-out will follow normal procedures, same as other blood components.
    2. Ward staff must provide a doctor’s prescription for CCP and a fully completed request.
    3. Ward staff will directly transport the CCP to the intended transfusion site.  They should immediately transport it to the patient transfusion site.
  8. Transfusion will be performed according to standard procedures:
    1. Positively identify the patient.
    2. Use a standard 180 micron blood filter.
    3. Transfusion should be done as quickly as possible to avoid potency loss
    4. Fill out the transfusion record and return a copy to the QHBB.