Tag: Quality Assurance

Quality Asssurance in Transfusion Medicine

Teaching Document: Variances in Transfusion Medicine

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Principle:

In accordance with AABB Standards, all actions contrary to the standard operating procedures and policies of Transfusion Medicine must be specifically approved by the Head, Transfusion Medicine or designate.

Documentation of variances must be organized in a system for ready retrieval for analysis.  They should not be entered into a system that is cumbersome to find the entered variances.

Examples include but are not limited to:  Rh(D)-incompatible transfusions, least-incompatible crossmatch, extension of expired rare reagents, etc.

If the same variance is occurring frequently, it should be determined if modifications in the underlying documentation (policies, processes, procedures) should be made.

Policy:

  1. Whenever there is need for a variance in the policies and procedures in Transfusion Medicine, the Division Head, Transfusion Medicine or designate must be informed.
  2. The Division Head or Designate will review and accept/reject the request.
  3. If accepted, the variance must be documented in writing by any of the following:
    1. A paper form (pre-blood bank computer system implementation) that can ultimately be scanned or an electronic version stored in Transfusion Medicine.
    2. A comment in an appropriate field in the Medinfo computer system
  4. All verbal authorizations for a variance (e.g. telephone call to Transfusion Medicine physician at night) must be recorded on a form and submitted to the responsible TM physician for review and signature.
  5. All variance documentation must be readily retrievable for analysis.
  6. All variances must be collated and assessed as part of the monthly quality review.

References:

  1. Technical Manual, Current Edition, AABB, Bethesda, MD, USA
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

Issues with Labels

drzeyd

You can have the most sophisticated blood bank software, but if you can’t read the labels or if they fall off, you have a disaster.  These are my thoughts from implementing our blood bank computer system back in 2013.

Check Digits:

Both ISBT specimen and product labels have an internal system to verify that they have been read correctly.  Within the blood bank software, this should not be a problem.  However, can your third party such as a hospital information system HIS read them?

ISBT Compatibility:

The institution’s HIS could not read the component labels.  To this date, the problem has not been fixed.  As a workaround, we sent them the ISBT label codes directly from the blood bank software.  The only complete transfusion record was in the dedicated blood bank computer system, not the HIS.  You could not rely on the bedside nursing entry at all.

The HIS did not use the ISBT database and had no values for the E codes.  Again, we had no choice but to send an abbreviated E-code descriptor to them.  We did not use their transfusion module at all, but one of our clients did.  They had to hard code the list of E codes in use with their descriptors into their HIS.

Label Adhesive

We tested candidate labels at room temperature, 1-6, minus 18, and minus 80 C.  We found that most of the labels’ adhesive were not sticking at minus 80.  For some, you could literally blow on the blood bag and the label fell off.  I imagined a scenario in which I opened a freezer and saw the blood bag labels all lying separately at the bottom.

RFID Tags:

Do you use an RFID tag integrally attached to the ISBT label OR do you stick a separate RFID tag?  If the latter, how do you ensure that you put the proper tag on the proper bag?

Readability:

Readability:  Can all your blood bank devices read your printed labels?  Do you have to adjust the printers for this?  Whose responsibility is it to do this? 

Labels printed outside the blood bank:

If you receive patient specimens from outside the blood bank, can your devices read them?  Who is responsible to adjust the printers in the wards and clinics?

Validations:

Who validated that the HIS prints the accurate complete label for the right patient?  We discovered that this was not the case with our HIS and needed correction by them.  Remember that any processes affecting Transfusion Medicine should be assessed by Transfusion Medicine.  Do not accept verbal assurances from anyone, not even your HIS.

2/2/21

Teaching Document: Validation Process

drzeyd

This is a teaching document for medical technology and transfusion fellows to explain the general structure of a validation.

Principle:

All validations must be planned.  A validation protocol must be prepared with specific criteria for acceptance.  All validations with attached evidence must approved by the Head, Transfusion Medicine.

Policy:

  1. A written validation protocol must be prepared in the advance and at least including the following:
    1. Specific parameters and number of iterations to be performed
    1. Designated staff to perform validation
    1. Documentary evidence of the testing
    1. Specific acceptability criteria
  2. The completed validation protocol must be submitted to the Division Head, Transfusion Medicine, or designee for review.
  3. Once the validation plan has been reviewed, it must be performed by the designated staff.
    1. Software validations will be performed in a specific test environment, not in the live, production system.
  4. The completed validation document, including screenshots of the software functionality if applicable, must be submitted to the Division Head, Transfusion Medicine for review.
  5. The equipment or software may only be used if the acceptability are met AND the validation is approved by the Division Head, Transfusion Medicine or designee.
  6. The completed validation protocol will be stored in the document control system.

Reference:

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

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

Opinion: Ready after Fellowship?

drzeyd

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.

Bacterial Risk Control Strategies for Platelets—USA

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I am attaching the US Center for Biologics Evaluation and Research CBER Guidance for Industry revision dated December 2020 to replace the one issued in September 2019.

This is a very detailed document that will require US blood centers to comply with newer more stringent safeguards to minimize the risk of bacterial contamination of platelet components.

The easiest way to comply is to universally pathogen-inactivate all platelet components:  then the rest of the algorithm does not apply.  I am happy that for over 10 years I have used pathogen-inactivation (riboflavin-based Mirasol, Terumo BCT) and not experienced any bacterial sepsis from platelet or plasma components.

For those of us practicing outside the USA, please note:

The US still does not permit pooled, buffy coat platelets to have either a 5 or 7 day outdate.  For pooled components stored at 20-24 C, the FDA only allows a four-hour outdate, regardless what the rest of the world permits.  Thus, the USA mainly uses apheresis platelets.

If you have pathogen-inactivated platelets, you are so fortunate that you don’t have to follow these other recommendations to have a low risk of bacterial contamination.

Reference:

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, September 2019 updated December 2020

CBER Guidance for Bacterial Contamination Guidance, Revised December 2020 (PDF)

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: Understanding Each Step of the Process

drzeyd

During an AABB inspection many years ago, I observed the Lead Assessor interacting with a medical technologist at the bench.  As expected, the Assessor asked in detail about the test and where the documentation and any teaching aids were located.  Most importantly, the tech was asked to explain the procedure step-by-step and if they knew WHY each step was done and how the various outcomes affected the test.

In my opinion, the WHY is the most important issue.  In our testing and processing, we are not baking a cake.  We do not need a mindless automaton to perform the steps without knowing what they are doing.  To get it right, the technologist must understand why he/she does each and everything—and what are the consequences for not following the procedure precisely.  If the staff member knows this, he/she has respect for the process and is more likely to adhere to the proper method.

In my interactions with my staff, I want to engage them in the importance of their testing to the patient’s care.  If they know that the result may affect the care, they may become more respectful of their work since they are part of the patient care team.

I want them to understand what each of the various results will mean to the patient, i.e. how he will be handled.  I give them updates about the patient’s condition.  A caring technologist is more likely to follow the steps properly.  They understand that a deviation from the process may adversely affect the patient.

To this day, I often go to the technologists and quiz them about what they are doing, e.g. why do they add a particular reagent, why the incubation time is 15 minutes versus 60 minutes.  I encourage them to check and recheck what they are doing if they have any doubts.  Working the bench is not a quiz or examination.  If they are uncertain, I want them to seek out the information, ask questions.  In fact, I tell them there is no shame in saying, “I don’t know”—but be certain to add, “I will find out what to do.”

Blood bank can be fatal to those who guess.  Each of us must know our individual limitations and seek the necessary knowledge.  In fact, many of my assessments are open-book.  They can use any resource in the blood bank or references on-line.  This is real life:  I discourage them from relying on memory if they are understand.  Our end point is the correct action.

13/12/20

Opinion: Handling Incorrect Physician Orders

drzeyd

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

Opinion: Transfusion Education for Physicians

drzeyd

Although there are resources allocated for nursing transfusion proficiencies, the training for physicians and medical students may not be as developed.

In medical school in the United States, I had one hour dedicated to transfusion medicine and it did not discuss the actual proficiencies necessary to select and physically transfuse patients.  In my clinical rotations, especially surgery, I was given “cookbook formulae” on what to order for different procedures—without any explanation.

I had considerable training in transfusion medicine during my pathology residency, and I took it seriously.  Many/most pathology residents are not interested in the topic and use the rotation for vacations and other business.  They learn what is necessary to pass the pathology board examinations and do not intend to practice this at all.  Actually, I sense that many practicing pathologists are afraid of blood bank and minimize their activities there.

What about the non-pathology residency training?  In the Middle East, some centers rotate the hematology, surgical, and obstetrics-gynecology residents through the blood bank.  In other posts, I have discussed some training plans I have used for each group.

Sadly, however, most practicing physicians do not well understand how to select and order blood components or administer components.  I try to tell them that they should at least know if the blood components being used for their family members are correct.

In a previous position, there were mandatory training programs for physicians including infection control, fire,  and disaster training.  There was even a program on handwashing!  Yet, there was no required training for transfusion practices.  I had offered to make such a training program but there was little interest.

Minimally, such a proficiency program should be offered to all physicians who might order a transfusion.  It should include:

  • Indications for transfusion of each component type including the institution’s transfusion triggers
  • Indications for modified components, e.g. irradiated, aliquoted, etc.
  • How to order blood components—manually and in the institution’s computer system
  • How to administer blood components, including the maximum transfusion times (e.g. four hours for RBC components), use of filters, etc.
  • Recognition and treatment of transfusion reactions and other adverse effects

In my career, I received blood component orders with many errors.  In the pre-computer, paper era, the blood bank staff automatically corrected these under the direction of the blood bank medical director.  Nowadays, with computer systems, it may not be possible for the blood bank staff to “autocorrect” the orders.

In my Middle Eastern practice, we could still correct the orders—even after adopting a blood bank computer system.  That will be the subject of a future post.