Traceability of Processes in Transfusion Medicine using Medinfo Hematos IIG

Principle:

As part of good manufacturing process, we must trace everything in Transfusion Medicine, from registration through release of components.  The adoption of the Medinfo Hematos IIG computer system allows us to document anyone and everyone who “touches” the blood components and all processes.

Policy:

  1. Each staff member must use his/her personal log-in to sign into Medinfo Hematos IIG HIIG).  Each transaction is recorded with the User ID.
  2. Through the Medinfo Hematos IIG  computer system, we can trace:
    1. Each staff member who handled every step of every process.
    2. Which equipment was used in processing
    3. Which materials were used, including serial number of blood bags and selected reagents
    4. For each component, the donor is identified, including review of all test results, physical examinations, and questionnaire
    5. For each patient, all components received (from which each donor can be traced) and all testing results including transfusion reactions and any applicable protocols
    6. For each reagent lot numbers, expiration dates
    7. For each blood component, test results, serial numbers of blood, transfer, and pathogen-inactivation bags, dates and types of all modifications, including any changes in component outdates, disposition of unit (transfused, discarded, quarantined, etc.)
  3. Units can be quarantined based on each of the above parameters to block release to and/or usage at all blood transfusion services/hospital blood banks.
  4. Upon request of the Division Head, Transfusion Medicine/LIS, designated Transfusion Medicine and HIIG staff have access to trace any of the above.
  5. All traceability incidents will be reported as variances and documented according to standard procedures.

References:

  1. Workflow processes for Medinfo HIIG, Current Versions
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

Blood Component Transport Temperature Monitoring

Principle:

Blood components must be maintained at specified temperatures to avoid hemolysis, bacterial contamination, and maintain full efficacy (e.g. coagulation factor activity.)

Policy:

  1. Freshly collected whole blood for blood component preparation must be kept between 20-24C if  platelets are to be made.  Otherwise, it must be maintained between 1 and 10 C.
  2. Prepared RBCs and thawed plasma must be transported between 1 and 10 C.
  3. Platelets (pools and apheresis), thawed cryoprecipitate, and granulocyte concentrate must be transported at 20-24 C.
  4. Frozen components (frozen RBCs, FFP, FP24, cryoprecipitate) must be kept frozen during transport.
  5. There must be an appropriate means of documenting that the proper temperature was maintained.  Examples of compliance may include:
    1. LCD stickers that change color if the component goes outside the selected temperature range.
    2. Digital temperature recording systems—Examples:
      1. TempTale ® or other temperature recording devices (added to a transport container without a temperature-controlled container)
      2. Temperature controlled transport containers with integral recording systems
      3. The recording session for each transport episode should be downloaded, reviewed and saved.
  6. If the temperature goes outside the specified temperature range, the components cannot be used for transfusion or manufacture.
  7. All devices must be validated to meet their specified temperature-recording capabilities before being used.
  8. Specific SOPs for the use of the selected monitoring devices must be prepared and in use.

Note the different temperature ranges for refrigerated components stored in the blood bank (1-6C) versus transport (1-10C).

References:

Section 5.6.5, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

DAT-Positive Hemolytic Anemias

This is a helpful Medscape diagram showing causes of direct-antiglobulin-test-positive hemolytic anemias.  Note that not all cases of the conditions may consistently be DAT-positive, especially the ones that fix complement.  Again, a negative result means non-detected, not necessarily not present.

In my own test algorithm, if hemolysis is suspected, I would perform monospecific IgG and C3 DATs.  I might also include a special DAT card detecting both C3c and C3d and heavy-chains mu (IgM) and alpha (IgA) if the initial DAT is negative.  C3c positivity would tell me that active complement activation is occurring.

Therapeutic Phlebotomy Process–Updated

Principle:

Therapeutic phlebotomy is a medical procedure that requires a written physician’s order and review/approval by a transfusion medicine physician.  Transfusion Medicine is responsible for the procedure and makes the final decision of the conditions of the procedure (volume of whole blood and venue).

Policy:

  1. The most responsible physician or a member of his clinical team will write a specific order for therapeutic phlebotomy including:
    1. Clinical diagnosis
    2. Medications
    3. Quantity and frequency of the procedure
  2. No procedures will be done without a physician’s order.
    1. Verbal orders may be given directly to the responsible transfusion medicine physician.
  3. Blood Donor Center nurses will NOT process orders from outside Transfusion Medicine.  Final approval is only by a transfusion medicine physician.
  4. Phlebotomy Process:
    1. Blood Donor Center nurses will obtain informed consent for the procedure.
    2. Blood Donor Center nurses or donor technicians will take the vital signs (BP, pulse, temperature, weight, and respiratory rate) and will examine the patient’s arms for suitability for phlebotomy.
    3. The doctor’s order along with the vital sign data will be given to the responsible transfusion medicine physician for review.
    4. The transfusion medicine physician will:
      1. Use the criteria of the Therapeutic Phlebotomy Annual Review
      2. Review the written (or verbal) order.
      3. Determine the exact quantity of whole blood to be removed.
      4. Determine if it is safe to perform the procedure in the Donor Center or:
      5. Advise the ordering physician of an alternate, appropriate venue (ICU, ER, CCU, etc.)
      6. Write the final order for the procedure in the appropriate Transfusion Medicine record.
    5. The actual phlebotomy will be performed the same as a whole blood donation using sterile technique including arm preparation.
  5. The collected volume will be discarded immediately after drawn.
    1. No therapeutic phlebotomy whole blood collections will be used for transfusion.
  6. Records of the following will be retained:
    1. Clinical doctor’s order
    2. Vital signs of patient
    3. Patient’s consent
    4. Any notes, including descriptions of reactions
  7. Reactions to the phlebotomy procedure will be handled the same as donor reactions.
  8. Any variances to the above process must be approved by the transfusion medicine physician, forwarded to the Head, Transfusion Medicine, for his review, and documented on the appropriate variance form.

References:

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

Annual Review:  Therapeutic Phlebotomy Criteria and Treatment Goals

Handling Nonspecific Antibody Panel Reactions

Note: this is an updated version of a previous post.

Anyone reviewing antibody panels, especially in the Middle East/Gulf region, encounters many panels for which no antibody specificity is identified.  As a transfusion medicine physician who often got called during the night for release of RBCs for patients with “nonspecific” pattern, this was a big headache.

Is it “nonspecific” because there isn’t a clinically significant antibody OR the technologist did not perform the testing or its interpretation correctly?  Does it need further testing?  Do I release blood components at this time?

In general, I do not routinely use polyspecific AHG for routine testing.  My first choice is for a gamma heavy-chain specific AHG but this is not available for gels or glass beads.  Then, I select the IgG AHG even though it does react with light chains and can detect IgM cold antibody reactions.

In general, with nonspecific reactions, I recommend the following:

  1. Repeat with a gamma heavy-chain specific reagent if the initial workup was made with another type of AHG (polyspecific or whole molecule IgG).
  2. Always do enzyme panels, sometimes with both papain and ficin reagents:  many Rh antibodies are optimally detected only at enzyme (example:  R1R1 patient with only anti-E at AHG phase but anti-E and anti-c at enzyme).
  3. Perform an extended Rh/Kell/Duffy/Kidd/Kell/MNSs/P1 phenotype and specifically check for those negative typing results AND for dosage (could the antibody only be detected in homozygous cells like many anti-M are?).
  4. Perform classical room temperature, 37C, and finally AHG phase testing.  Routinely I do not do this since antibodies not detected at 37C are unlikely to be clinically significant.  Sometimes, the AHG phase reactivity is a cold antibody of high-thermal amplitude.
  5. If the Jka or Jkb antigen typings are negative, repeat using a polyspecific AHG reagent.
  6. Use additional panels from multiple manufacturers.  Some reagents detect more nonspecific reactions than others.
  7. Try other potentiators than LISS such as PEG.
  8. Check the outdate of the panel and reagents:  if less than 1 week remaining, consider repeating with fresh reagents and getting a new patient sample.

Finally, if you still cannot define the specificity, consider repeating the testing after several days.  Maybe it is a newly emerging or an anamnestic response.

I emphasize as a physician, I do not care to see all possible antibodies present in the specimen but rather only those likely to be clinically significant.  In general, there is a shortage of labor in the blood banks so I want to eliminate unnecessary work.