Sample Stem Cell Collection Apheresis Form

This is a sample of the stem cell therapeutic apheresis form that my apheresis team and I developed. It can be readily made into an electronic form. I want to thank Dr. Saloua Al Hmissi, Apheresis Consultant, and Ms. Mini Paul, Head Apheresis Nurse, for their efforts in making this form a success.

Pre- and Post-Exposure Antiretroviral HIV Prophylaxis

Principle:

Use of anti-retroviral therapy as prophylaxis for pre- or post-exposure (PrP or PEP) HIV prophylaxis may lower the viral load below detectable levels.

Policy:

  1. Defer any donor taking PrP or PEP anti-retroviral ART medications for three (3) months since the last dose.
  2. Donors taking ART drugs as treatment for HIV infection are still indefinitely deferred.
  3. Donor information pamphlets should be updated to include this new deferral.

References:

  1. AABB Association Bulletin #4, The Impact on Blood Safety of Effective Antiretroviral Medications for HIV Prevention and Treatment, 5/5/20
  2. DHQ Medical Deferral List, Version 2.1, AABB, Bethesda, MD, USA, June 2020

Off-Line Donor Medinfo Transactions

Principle:

When you cannot establish a direct link to the live Medinfo program, you must arrange for the local Medinfo engineers to create a local server that will have the current Medinfo donor database for use at outside campaigns where the internet connection cannot be used.  This can also be used if for some reason the Blood Donor Center link is down in order to register donors and check the donor deferral database.

Policy:

  1. For each outside campaign, there should be a pre-campaign visit to verify the availability of internet to connect to Medinfo.
    1. If the internet connection is working, use Medinfo using the 4G access points.  Otherwise:
    2. If none, inform the Medinfo engineers to prepare a local server on one of the laptops at least ONE DAY in advance of the campaign.
      1. Give Medinfo engineers the laptop to download the database and software.  This will be the offline server for the campaign.
      2. Link the offline server to the other portable computers for the campaign (see the corresponding Medinfo job aid).
      3. Use the local network (offline server and other portable computers) for registering donors.
      4. Upon return to the Blood Donor Center, upload the data.
      5. Continue the regular processes after uploading.

Note:  When the offline data is uploaded into Medinfo main database, it will be checked against the latest donor deferral database.  The latter will be applied for the donation.

Enzyme Panel Details

Principle:

Performing antibody panels using both enzyme (ficin, bromelin, and/or papain)-treated  and routine panel cells may be necessary to detect most clinically significant antibodies

Policy:

  1. Regular (LISS) panels are to be performed using AHG reagents whereas enzyme panels done by the gel technology must use the saline (NaCl)-enzyme card.
  2. Perform BOTH enzyme and routine panels in the following situations
    1. All patients with sickle cell anemia and thalassemia
    2. Antibody pattern of panreactivity with a negative autocontrol (see attached examples)
    3. Antibody workup that does not show a specific pattern with the regular panel alone
    4. Any case with a previous history of antibodies with a current negative antibody screen
    5. Any other case that you are directed to do so by the transfusion medicine consultant, supervisor, or senior technologist.
  3. Remember the reactivities of the following antibody specificities with enzyme-treated cells:
    1. Reactions may not be the same with papain vs ficin-treated cells!
    2. Enzyme-labile with both papain- and ficin-treated cells:  Fya, Fyb, M, N, Ge2, Yta, Rg, Ch, Pr, Tn, Mg, Mia, Cla, Jea, Nya, JMH, Inb
    3. Variable, enzyme-labile or weakened, some unchanged with both papain and ficin-treated cells:  S, s, U
    4. Variable reactions with papain (labile, weakened, unchanged, or increased) but usually increased or unchanged with ficin-treated cells:  Kell system (K, k, Kpa, Kpb)
    5. Reactions are increased or unchanged with both papain and ficin-treated cells:  Rh (D, C, c, E, e), Jka, Jkb, Lea, Leb, Lua, Lub, P1, H, most cold antibodies, autoantibodies, Tja (PP1Pk)

Example 1:

Antibody to High-Incidence/Prevalence or Public Antigen:

Reactions destroyed by enzyme (typical of anti-Ge2):

Example 2:

Antibody to high-incidence antigen, reactions unchanged or enhanced by enzyme—VERY DANGEROUS PATTERN:  Examples:  Anti-H, Anti-Tja (PP1Pk), anti-k (cellano), anti-U

Assessment of External Technical Qualifications

Principle:

The development of Transfusion Medicine will include recruitment of technical staff with external qualifications, often higher or more advanced than current on-site staff who normally would make their competency assessment.  This policy addresses an interim approach to making a fair, unbiased assessment of these highly qualified staff and avoid conflicts.

Definitions:

External Qualifications:  BB(ASCP), SBB(ASCP), MT(ASCP), MLS(ASCP), RT, ART, AIMLS, FIBLS, or equivalent

Designated Assessor:  Supervisor, SBB, Specialist Physician, or other staff designated by the Head, Transfusion Medicine to perform the assessment

Scope:

This policy applies to all initial (probationary), annual, and all other competency assessments across ALL HMC transfusion services and the Donor Center.

Policy:

  1. Technical Issues:
    1. All staff with external competencies as defined above will have a special assessment for technical skills if there is not a senior staff member with at least the same or higher technical external qualification (e.g. SBB(ASCP), FIBLS, ART for BB(ASCP), RT, or AIMLS).
    2. Senior staff (e.g. SBBs, specialist physicians at outlying hospitals) other than the direct supervisor may perform this technical evaluation if so designated by the Head, Transfusion Medicine.
    3. The supervisor or other designated assessor will liaise with the Head, Transfusion Medicine to develop this assessment for technical skills.
    4. The final arbiter for the content of the assessment will be the Head, Transfusion Medicine.
    5. All such evaluations will be sent by the designated assessor to the Head, Transfusion Medicine for his review and approval.
    6. NO evaluations will be submitted to Laboratory Administration until they have been reviewed, accepted, and signed (with stamp) by the Head, Transfusion Medicine.
  2. Non-Technical Issues:
    1. Non-technical and administrative skills assessment will continue to be conducted by the Supervisor or Specialist Physician of the corresponding transfusion service.  New staff must become proficient in both technical and non-technical issues as described in the job description.
  3. Utilization for Special Procedures:
    1. The Head, Transfusion Medicine reserves the right to utilize such staff for performing special investigations, (e.g. antibodies and other complex immunohematologic testing) even before their full competency assessments and reviews are complete.
      1. In such situations, the Head, Transfusion Medicine assumes full responsibility for such actions.

References:

Standard 1.1.1. and Section 2, Standards for Blood Banks and Transfusion Services, 30th Edition, AABB.

Processes and Software Building 56: Multi-Site Patient and Donor Considerations

As our hospital network expanded, there were many patients who moved between locations.  They might first start in an emergency room and then be transferred to a specialty hospital.  These locations might be served from different hospital blood banks/transfusion services.  What happens if work is progress from one site when the new site receives the patient.  Must the previous workup be repeated or could it be used for transfusion at the next site?

For example, the ABO typing could be performed at one site and the antibody screen at a second site, and the antibody identification at still another site.  Could the results be used across the entire system?

I had multiple hospital blood banks and blood donor centers.  The general and specialty laboratories had multiple sites.  The hospital information system was set up so that the various tests could only be performed at specific designated sites.  This posed problems as patients were moved around or if some site(s) became inoperative since the specimens then had to transported at great distances for testing.  Only a few basic STAT tests were available at all sites.

It was my decision to allow all test categories at all sites, e.g. a DAT request from any site, any methodology, could be used to satisfy the order.  Similarly, all donor processes were available at all donor centers (the processes could be completed at one or more sites).  Different hospital blood banks had different equipment but all the test categories were the same across site—the methodologies might differ.  We had at least four different DATs across our system.

The interface between the blood bank and hospital system worked as follows:  In the hospital information system HIS, test orders pointed to a category of testing and any methodology for that category at any site could be used in the blood bank system for testing and reporting back to the HIS.  Any test in a category from any site could be used to satisfy the test request.  Blood bank staff would choose the particular test methodology to use.  It was NOT specified by the HIS!

In summary, for blood banks and donor centers within our system, the work could be flexibly moved between sites.  There was no need to repeat testing when a patient transferred to a new site.  The only type the work was repeated if testing was done at an institution outside our system.

Training Future Transfusion Medicine Physicians: Need for Technical-Medical Expertise

In a previous post, I discussed transfusion training for hematology fellows and general pathology residents.  I have no expectations that most of them have any interest in the field so I suggested concentrating on the interpretation of the direct antiglobulin test DAT and turn-around-times for services.

In contrast, the transfusion medicine physician in-training needs to understand in detail all processes, donor and patient—especially test interpretation so that he/she can make medical decisions and variances.

During my training, I was fortunate to be in a residency training program that also had an American Specialist-in-Blood Bank SBB training program.  To a large extent, I attended the SBB program and even worked on the “wet” specimens.

I had no delusions that I would ever function as technologist or SBB in the blood bank.  However, that extended blood bank training has made me the physician I am.  I can correlate advanced, even reference, procedures to my medical knowledge and thus provide a unique offering.  In contrast, even the SBB is not a physician and cannot make the medical correlations.  Recently, I was flattered at an AABB meeting when the speaker thought that I was an SBB.

In certain regions where reference immunohematology laboratories and SBBs or equivalent are rare, the transfusion medicine should have sufficient technical background to help fill this gap.  In my practice, I review all antibody and DAT workups and make interpretative comments for the physicians and nursing staff.  These comments are entered into the blood bank computer system.

I personally tutor the trainees and make certain that they understand potentially dangerous patterns such as antibodies to high-incidence antigens, significance of the autocontrol in panreactivity, and assessing for fatal acute transfusion reactions—both hemolytic and non-hemolytic.

It also helps when I can discuss with my technical staff my interpretations and choices for clinical management.  They get a better idea how important their work is for patient care and understand how any errors may adversely affect the patient.

In regions where there are good immunohematology reference laboratories, some of this may be less necessary.  I lament that transfusion medicine physicians may not maintain these skills and must rely on others to their detriment.  Even if one is comfortable with this, the physician is still ultimately responsible for making the clinical decision.

ABO Subgroup Testing for Organ Donors

Principle:

Organ donors with a history of RBC transfusion within the past three months must have ABO subgroup (weak A as detected by A2 cells and anti-A1 lectin) if the transfusion included group A RBCs.

Policy:

  1. Organ donors who are typed as A should be tested to distinguish group A1 from weak subgroups of A.
  2. Use anti-A1 lectin and A2 cells as indicated.

Reference:

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

Sample Validation Change Protocol: Donor Hgb Levels

Changes to donor criteria can occur at any time.  This example is the change in donor criteria for males to 13.0 g/dl based on AABB Bulletin #16-05.

I made a validation protocol, which was subsequently performed by a Donor Center Medinfo Super-User.   The data was then sent to me for review and then accepted.

Note that females were included in the testing for regression purposes.  Females were only permitted to donate RBCs—all other components were discarded in production. Contraindication information appears in RED.

Biologic Product Deviations

Principle:

Any nonconforming product that is released for patient use must be reported through the official channels.  Since there is no equivalent to the US CBER, this policy outlines the process for the HMC organization, the only provider of blood components for the State of  Qatar.

Definition:

Nonconforming Blood Component:  Any blood component not meeting the production criteria set in the policies, processes, or procedures of Transfusion Medicine.  Some examples include:

  • Low-volume RBC or FFP/FP24 units
  • Reduced yield platelet units
  • Units made with materials/supplies that have been recalled by the manufacturer
  • Units produced on equipment or tested with reagents that the manufacturer has recalled from use
  • Units contaminated during the production process

Policy:

  1. Nonconforming components must not be released unless they are reviewed and approved by the Head, Transfusion Medicine.
    1. Full written documentation of the review and the reasons for acceptance must be recorded.
    2. Such acceptance must be exceptional—there must be emergency reasons to resort to using such components.
      1. Minor nonconformances such as units with low volume or reduced platelet levels may be considered for use at times of critical shortage of blood components if they otherwise meet acceptability criteria.
  2. If anyone suspects there has been release of a nonconforming blood component, they should immediately contact the Division Head, Transfusion Medicine.
  3. The Division Head, Transfusion Medicine will conduct an immediate investigation to determine the veracity of the allegation.
  4. If the suspicion is confirmed, the Division Head, Transfusion Medicine will immediately contact the Chairperson, Pathology and Laboratory Medicine.
  5. The Chairperson in conjunction with Head, Transfusion Medicine, will inform the Medical Director and other senior administrative officials as indicated.
  6. A lookback will be initiated to determine if any patients have received the nonconforming components.
  7. The results of the lookback will be reported to the Chairperson, Pathology and Laboratory Medicine and the Medical Director.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition