Category: Donor

Includes registration, questionnaire, physical exam and arm check, collection, marker testing, component separation, donor immunohematology testing

Traceability of Processes in Transfusion Medicine using Medinfo Hematos IIG

drzeyd

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

drzeyd

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

Therapeutic Phlebotomy Process–Updated

drzeyd

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

Autologous Transfusion

drzeyd

This a revised version of a previous post for the processes of autologous transfusion that I developed at HMC Doha.  It can serve as a template for other sites and was also a teaching document for the Transfusion Committee members.

Background:

There are four basic types of autologous transfusion:  preoperative, perioperative hemodilution, intraoperative, and postoperative drainage/collection.  The use of all of the above techniques can significantly decrease the need for homologous blood and as an added benefit reduce the risk of the disease transmission and immunosuppressive effects of such homologous transfusions.

Preoperative collection can make available packed red blood cells, whole blood, platelets, FFP, and/or cryoprecipitate.  However, at most two units of blood per week can be collected.  RBC’s can be stored for up to 42 days in the liquid state, frozen RBC’s up to ten years, platelets up to five days, and fresh frozen plasma and cryoprecipitate up to one year.  The last collection cannot be less than 72 hours prior to the surgery time.  Units can be collected as long as the patient’s hematocrit remains above 33%.  Supplemental iron and erythropoietin can increase the number of units harvested.  The biggest obstacle to using this service is the coordination of the patient scheduling for this procedure.  The blood bank does not have the resources to prospectively analyze the surgical scheduling and make the various appointments, contact the attending physician, etc.  Thus, this service is vastly underutilized.

PHD or Perioperative hemodilution (also called acute normovolemic hemodilution) is useful in cases when the anticipated blood loss is at least one liter and the initial hematocrit is at least 34%.  This includes essentially all types of surgery, but in particular cardiac, vascular, orthopedic, and urologic cases.  The patient’s hematocrit Hct. is lowered to the range of 20-25% and the blood is replaced by crystalloid in a ratio of 3:1–i.e. three times as much fluid as blood, or in the case of colloid replacement, a 1:1 ratio of colloid plus 0.5 to 1.0 ml. of crystalloid.  Crystalloid has the advantage of being readily removed by diuretic use.  However, this technique should not be undertaken when vascular access is inadequate or appropriate monitoring devices are lacking.  The physician performing PHD must be familiar with the compensatory mechanisms normally invoked when the hemoglobin is acutely lowered.

Another new twist to PHD is the perioperative collection of platelets by a special attachment to a cell-saving machine.  This could allow collection of a typical apheresis load, about 6 to 10 units of fresh platelets for potential use.  There are currently studies underway to determine if this has particular clinical advantages to warrant the additional cost.

Intraoperative salvage may be performed with a number of canister or automated devices.  The latter is usually used when there are large volumes (usually 3 or more units) of blood to be salvaged.  Depending on the body site, the recovered material is at least filtered and may or may not be washed.  Care must be taken to collect the blood at a low suction rate and with minimal turbulence to minimize hemolysis.

Postoperative drainage collection of certain sites such as post-knee replacement surgery or chest wounds involves a canister collection device.  This blood may or may not be filtered before reinfusion.

Note that perioperative and intraoperative material can only be transfused up to six or eight hours at room temperature or 24 hours if refrigerated at 1-6 degrees (depending on the method used) post collection to minimize the risk of infection.  Intraoperative collection may be contraindicated in cases of cancer and if the bowel has been violated.

Other Issues:

The transfusion criteria for autologous blood is the same as for allogeneic units.

The same compatibility testing algorithm applies both the autologous and allogeneic units.

Policy:

  1. Scope:
    1. Predeposit collection of Whole Blood/RBCs and plasma is under the authority of Transfusion Medicine.
    2. Perioperative hemodilution, intraoperative cell salvage, and postoperative drainage collection is under the authority of the National Transfusion Committee in conjunction with the Departments of Surgery and Anesthesia.
      1. The Division Head, Transfusion Medicine will liaise with the clinical departments as needed.
      2. Transfusion Medicine may provide blood collection bags for perioperative hemodilution upon request.
    3. Transfusion Medicine does not receive autologous collections—perioperative, intraoperative, or postoperative drainage collection.
  2. Processes directly under Transfusion Medicine authority:
    1. Autologous collection of whole blood/RBCs (pre-deposit) for elective surgeries may be considered especially if:
      1. The patient has a dangerous antibody for which antigen-matched units cannot be easily obtained (e.g. anti-k (cellano), anti-PP1Pk (anti-Tja), anti-H (Bombay and Para-Bombay phenotypes).
    2. Autologous collection of plasma may be considered for patients with IgA deficiency with documented specific anti-IgA antibodies.
    3. Other requests will be reviewed by the Head, Transfusion Medicine or designate.
    4. The final decision to proceed with items 2.1 and 2.2 will be made by the Head, Transfusion Medicine or his designate.
  3. Process for Transfusion Medicine Autologous Procedures
    1. The requesting physician shall provide a written or electronic order to the Blood Donor Center.
    2. The request will be reviewed by a transfusion medicine physician.
    3. If rejected, the requesting physician will be notified with the reason for the rejection.
    4. If approved, the donor shall be screened by the usual donation process except:
      1. Hgb >= 11 g/dl will be acceptable for whole blood collection.
      2. Females may also donate autologous plasma.
      3. The last autologous donation will be at least 72 hours before the elective procedure.
    5. Marker testing:  Components from autologous donors with confirmed positive cases of HBV, HCV, or HIV will NOT be used for autologous donation and will be destroyed.
    6. Computer:  Autologous collections will be entered as specifically at the time of registration in the Medinfo  Hematos IIG blood bank computer system and be labeled as autologous in their corresponding ISBT labels.
    7. The transfusion criteria for autologous units shall be the same as for homologous blood.
    8. Both autologous and allogeneic units will follow the same compatibility testing algorithm.
  4. Responsibilities:
    1. Predeposit:  Directly under the control of Transfusion Medicine for all aspects:  policies, procedures, and direct performance of the procedures, including annual review of criteria
    2. Perioperative:  Division Head, Transfusion Medicine involved in conjunction with Surgery and Anesthesia through the National Transfusion Committee.
    3. Intraoperative:  Division Head, Transfusion Medicine involved in conjunction with Surgery and Anesthesia through the National Transfusion Committee.
    4. Postoperative:  Division Head, Transfusion Medicine involved in conjunction with Surgery and Anesthesia through the National Transfusion Committee.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA, 2014
  2. TRM.41600 CAP Checklist Standard

Opinion: Outsider Access to Blood Bank Software

drzeyd

I designed my blood bank software Medinfo for use by my staff at all levels and positions to adhere to and facilitate compliance to the workflow processes.  Blood bank staff were restricted to access only those functions needed for their job duties.

Blood Donation records could not be viewed by outside staff for confidentiality reasons.  Blood donor records were not linked to patient records at all.

We did not allow access for Medinfo to non-Transfusion Medicine staff since the screens were designed to maximize efficiency of the work processes, not the viewing by outsiders of results.  Outsider access was made through the hospital information system HIS.

The separate hospital information system HIS interfaced to Medinfo for the following functions:

  • Ordering blood components
  • Ordering a limited number of tests from which algorithms would be generated on the blood bank side for further testing
  • Querying the status of the test or component orders (e.g. ordered, collected, in blood bank being processed, completed)
  • Viewing of completed tests and component requests

Even within the HIS ordering capabilities, there were additional restrictions:

  • Blood components:  outside doctors could order base blood components could be ordered, but special processing such as washing or irradiation followed internal blood bank rules.  Outside physicians could state their preferences in an order comment, but blood bank rules applied.  Any disagreements had to be discussed with the transfusion medicine physician.
  • Testing:  Only base tests such as ABO/D typing, antibody screen, direct antiglobulin test, transfusion reaction workup, and cord blood testing could be directly ordered by outside physicians, but further testing depended on the results of these tests as allowed by internal blood bank algorithms.  An outside physician could not directly order other tests but had to discuss his concerns with the transfusion medicine physician.

Results viewing in the HIS were subject to additional conditions as well:

Only certain results, not all results were viewable directed in the patient’s chart since showing all results may be confusing to the outside physicians and nurses.  The selected results were sent back into the HIS for viewing.  All these non-viewable results were retrievable for blood bank staff in Medinfo.

Another option, one I did not use at either HMC Doha or NGHA in Saudi Arabia, was to order tests and components by physicians directly into Medinfo.  Likewise, they could view test results directly in the system.  Special screens could be constructed to offer ordering and results retrieval.

Use of Expired Reagents

drzeyd

This is a sample document for use of expired reagents I wrote for HMC Qatar.

Principle:

Due to logistics issues including the long distance between suppliers in Europe and North America and Qatar and the importation/customs clearance of critical materials, Transfusion Medicine has developed a contingency variance policy to minimize disruption of the essential transfusion medicine testing and component preparation.  Approval for use of outdated reagents in special circumstances is not meant to be an excuse for untimely monitoring and improper ordering of supplies.

Definition:

Rare Reagent:  Any reagent that is either used uncommonly or is in short supply and difficult to obtain in a timely matter.

Policy:

  1. Maintain a minimum six (6) months’ supply of each reagent when feasible.
    1. This cannot be done for short-outdate reagents such as reagent red cells for panels and antibody screens.
  2. If an in-date reagent is not available for use, then an outdated reagent may be considered for use if:
    1. It passes an in-run quality control including negative and positive controls as applicable specific for the test in question.
    1. Supervisor reviews the results and approves their use:
      1. Results using such outdated reagents may only be used if they pass the validation rules in that procedure.
    1. The Division Head, Transfusion Medicine, or designate reviews the supervisor’s recommendations and approves their use.
  3. All such variances must be documented as follows:
    1. Variance document form
    1. In the comments for results within the Medinfo Hematos IIG software.

References:

Sections 1.3.2 and 7.0, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

SARS-CoV-2 Antibody for CCP in Medinfo Hematos IIG

drzeyd

When I started my COVID-19 convalescent plasma CCP collection in early March, 2020, there were few antibody tests available.  However, I anticipated that eventually we would want to include antibody results with the donor record.  Antibody results were not used originally at all in the criteria for CCP acceptability for release.

There are many assays by type of antibody (total, IgG, IgA, IgM) and quantitation by titer and/or signal-cutoff ration S/CO.  Any of these parameters may be used to define rules for acceptability to complete production and/or allocate to patients.  Instrumentation used for titering/quantitation may be interfaced to the blood bank software.

Here is my generic approach to including these results with the donation record.  In Medinfo HIIG, it is possible enter test results retrospectively and these can be used set rules for acceptability.  Please consult with my detailed post on using rules against parameters.

All of this is easily implemented since all test information will be stored as parameters.  From these parameters we can construct rules for:

  • Low titer CCP
  • High titer CCP
  • Acceptability for patient allocation

Also, one can override the rules if the clinician and the transfusion medicine physician agree.  For example, there is a severe shortage of group B CCP so use of low-COVID-antibody titer group B CCP could be allowed.

The key is to build whatever test methodology you use and include the manufacturer’s cutoff for low versus high titer interpretation.  These results can be printed on the ISBT label as well.  One can easily build multiple methodologies and acceptability criteria if different tests are used at different testing sites in your system—just as can be done for other tests (ABO/D, antibody screen, etc.)  If one changes methodologies in the future, Medinfo will still use the same rules that applied for the day of production.

Here are some sample test rules:

Example 1:  Total COVID antibody > 160 is high titer:

  • If antibody >= 160, label as high-titer CCP and use for patient allocation.
  • If antibody < 160, label as low-titer, physician must override for patient allocation

Example 2:  IgG antibody with S/CO ratio > 12 is high-titer:

  • If S/CO >= 12 label as high-titer CCP and use for patient allocation.
  • If S/CO < 12, label as low-titer and discard.

Example 3:  IgG and IgM antibodies must have S/CO > 12:

  • If BOTH IgG and IgM antibody measurements have S/CO >12, use for patient allocation.
  • Otherwise, discard unit.

Another option would be just to record the quantitation for each antibody type and list this on the ISBT label and permit its release regardless of the value.  One could also permit low-anti-B titer group A plasma with whatever rules you set up.

COVID-19 Convalescent Plasma CCP Product Issue

drzeyd

This is the conclusion of a continuing series of posts on the actual Medinfo design of the CCP donation and release processes and covers the transfer of completed units to the hospital blood banks.  It highlights specific changes made for the parallel CCP system I developed at HMC Doha.

A blood component is either located at a production site, a destination hospital blood bank site, or in transit.  Here a quarantine production site is specified.  The actual release process is documented in this post.

In summary, with the exception of the donor marker testing and immunohematology testing, all other CCP processes are handled by special quarantine processes.  There are abbreviated marker testing specific for plasma and a special Predonation screening to minimize wastage of the expensive apheresis kits.