Building Donor Center Software Processes: Donor Physical Examination and Adverse Reactions

Donor physical examination, along with the donor questionnaire, are important both for donor and patient safety.  In general:

Is it safe for the donor to donate?

Is it safe for the patient to receive the blood even if it is safe for the donor to donate.

Any donor who does not feel well must not donate.  This may be the single most important step in ensuring a safe blood supply.

The donor physical examination includes the vital signs (blood pressure, pulse, temperature, heart rate, and temperature).  I have attached a sample set of criteria for review.  All are user-definable.  Note how the arm examination is also included (looking for scarring, skin lesions, etc.)

For all types of donations, there may be adverse reactions.  These must be documented in the record along with the disposition of the donation.  Will the donor need an extended deferral if the RBCs in the apheresis run are not returned?  This can be built from the reaction documentation.  Note the following sample table of reactions.

To Be Continued

Building Donor Center Processes: Setting Deferral Intervals between Donation Types

Donation can be whole blood or apheresis-based.  The sex and age for each donation type is specified.  At HMC, we did not accept females for platelet or plasma donations, so the starting age is listed as 99 years.  Otherwise, in accordance with Qatari law, the starting age for donation is 18.  All these parameters are user-definable, and a transfusion medicine physician can override the rules if necessary.

For each and every combination of donations, the deferral interval must be specified.  Examples follow.  The temporary deferral period is in days:

Previous donation whole blood, current donation whole blood:  56

Previous donor platelets, current donation whole blood:  2

Previous donation whole blood, current donation platelets:  56

Also note how for each possible combination there is an entry for male AND female.  Females are restricted to whole blood donation and only RBCs will be made from the collection.

If there is a collection incident and the apheresis procedure is not completed, the interval will be set to 56 days.  This will be covered in the post on donor adverse effect reporting.

To Be Continued:

Building Donor Center Processes: Donation Type and Bag Parameters

At the time of registration, the type of donation must be specified.  In my last position, this could include whole blood for automated Reveos, whole blood for cryoprecipitate, plasmapheresis, COVID 19 convalescent plasmapheresis, plateletpheresis, concurrent platelet and plasmapheresis, concurrent platelet, plasma, and RBC apheresis, RBC apheresis-one unit, and RBC apheresis-2 units.

There is also a specimen-only donation without actual collection that includes database check, assignment of an ISBT specimen number, donor questionnaire, physical examination, and specimen collection only..

We specified which bag or kit could be used for each type of donation so when it was selected, only that bag type would be accepted by Medinfo

For each of these types we must specify what type of donation is permitted:  volunteer, autologous, or directed.

Finally, we must indicate the maximum length of the procedure permitted.  This applied to whole blood only and we set this at 15 minutes—this is user definable.

The following are a sample set of parameter settings for the above:

Note how we included contingencies for old bag sets and equipment (that we later discontinued) and for granulocyte collection (which we did not actually perform).

To Be Continued:

Building Donor Center Processes: Registration and Pre-Donation Parameters

The potential donor enters the collection area.  He takes a number and waits to be called.  When called, he shows a picture identification card with a unique alphanumeric sequence.  This is entered into the donor module software and the system checks the donor deferral database for temporary and/or permanent contraindications.  If none are found, a consent form with an ISBT specimen number is generated.

In this post, we will consider:

  1. Registration process in multiple languages
  2. Donor deferral database
  3. Donor consent with generated unique ISBT specimen number
  4. Registration Parameters

Registration:

In the Middle Eastern region, multiple languages are used.  Although Arabic may be the main language, not all the registration staff may speak it.  English is commonly used as the main work language.  The date may be entered as Common Era (Gregorian) and/or Hijri.

An issue is that for native Arabs, the only precise, unambiguous name spelling is in Arabic.  English transliterations vary.  Example, Muhammad in Arabic is very simple to write, in English it may be rendered as Mohamed, Mohammed, Muhammad, etc.  The donor’s name should be recorded exactly.  How do you register when the staff do not speak or type Arabic?

Fortunately, I have worked with software that is in UNICODE, meaning that the data does not have to be restricted to English (I wonder why the hospital information system we had at one institution could be sold in the Middle East and not have this capability!).  That means we could perform registration and donor questionnaire tasks in multiple languages, and preferable the native language of the donor.  We could even prepare database reports in Arabic.

Medinfo had an elegant solution to the registration process.  It read the local identity card issued by the Ministry of Interior and accessed (read-only) the demographic data on that donor.  Just by reading the bar code one received both English and Arabic name fields:

This would generate the demographic fields in the registration:

The blood bank software would check the national donor deferral database and list any deferrals/contraindications to donation and the next eligibility date.  It would also list what type of donations were permitted (e.g. for females, only RBCs could be collected and processed:  if a whole blood unit was collected, then the platelets and plasma would NOT be permitted to be processed and were discarded.)

Medinfo used a unique key field, the Medinfo Hematos Donor ID for the database.  This was not the same as the national ID card.  All records were indexed against this number.

Donor Deferral Database:

Medinfo imported donor data from a previous system and added this to its own database.  Thus, there was only one database to check.  The database listed all previous donations:  dates, type, status (complete, aborted).  Any contraindications would be prominently shown in RED.

Donor Consent and Assignment of Donor Unit (ISBT Specimen) Number:

If there were no contraindications, Medinfo generated a donor consent in English and Arabic and the unique donor unit number for the current encounter:


Registration Parameters:

Medinfo enforced registration according to the format of the identity card.  The donor ID format was built into Medinfo.  If the entry deviated from this, it was rejected and registration could not continue:

The registration type would be selected (volunteer, autologous, directed, or paid).  In Qatar, paid donations were not permitted:

Next, the donation type had to be selected:

At the time of registration, the type of collection bag (or kit if using Reveos) was automatically set in Medinfo.  I will consider this further in the next post of this series to determine eligibility based on the previous donation interval.

At each donation site, the allowable types of donations and kits could be set.  Based on the donation parameters above, staff could not select the wrong type of bag/kit (e.g. an apheresis kit for a mobile donation).

To Be Continued:

Building Processes for the Blood Donor Center: Donor Collection and Screening Current and Future States

This is a first is a series of detailed posts of how I collaborated with Medinfo (Nice, France) to build customized donor software for both Saudi National Guard Health Services and Hamad Medical Corporation Doha.

In particular, we were using a non-turnkey software which could be built to order.  If we didn’t know what we were currently doing, how could we build something better?

At both sites, we had good manual systems in effect and prepared detailed mapping of the current state.  We reviewed our variance reports to see where we needed to bolster the system and improve the critical control points (page 2).

We studied the software options and prepared a draft Medinfo future state (page 3), from which we started to build the system.  We did this in small stages so we could test it and adjust our settings as needed—without being charged extra (unlike a general laboratory software I had been working with at the same time).

To do this, I engaged early a team of my most computer-literate staff to work as Super Users.  In the Donor Center, this consisted of nurses and technologists.

We then prepared a Medinfo flow chart overview from this:

To Be Continued:

Process: Donor Reactions

5.6.1 PROCESS:  Donor Reactions

Process:

  1. Donor is continuously observed in the collection and post-donation areas by collection staff.
  2. Staff respond promptly to any adverse effect.
  3. Staff contact transfusion physician immediately if they cannot treat the reaction.
  4. Donor is referred promptly to emergency service if the transfusion physician cannot handle the situation or is not on premises.
  5. All reactions are documented in the adverse effects log and Hematos IIG.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Policy: Donor Reactions

Document Enumeration:  5.6

Policy:

  1. All donors must be continuously observed throughout and after the collection process.
  2. Donors showing any signs of an adverse reaction must be treated promptly.
  3. All collection staff should be trained and deemed competent to handle donor reactions.
  4. All adverse effects should be recorded in the appropriate log AND the Hematos IIG system.
  5. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, and JCI).

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Process: Donor Collection

Process:  Donor Collection

Zeyd Merenkov, MD, FCAP, FASCP

Independent Consultant in Transfusion Medicine

5.4.1 PROCESS DONOR COLLECTION:

Process:

  1. Donors must pass and complete all previous processes in the donor workflow (registration, questionnaire, and physical examination) before the collection process begins.
  2. The donor is positively identified by a designated picture ID and Hematos donor consent form with specimen/encounter number and barcode.
  3. Donor staff checks and prepares a suitable vein
  4. Donor staff collects/labels specimens and the whole blood or apheresis components AT THE DONOR’S BEDSIDE.
  5. Donor reactions are assessed and treated as they occur.
  6. Donors are observed in a post-donation area and given post-donation instructions before discharge.
  7. All processes are documented in Hematos IIG.
  8. Donor units and specimens are sent to component processing and donor marker testing.
  9. The collection workstation and equipment are cleaned before starting a new donor collection.

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA

Policy: Donor Collection

5.4 POLICY: DONOR COLLECTION

Policy:

  1. All donors will be positively identified with a picture ID and by their Hematos identifiers (donor ID and session registration/specimen number).
  2. All previous processes (registration, donor deferral database check, questionnaire, and physical examination) must pass.
  3. The donor’s arm veins will be inspected for a suitable donation site and prepared by a suitable aseptic technique.
  4. Whole Blood:
    1. Only whole blood units collected within the specified time interval may be used for component processing.
  5. Apheresis:
    1. Apheresis units will be collected at frequencies to keep the total RBC loss below 200 in any 8-week period.
    2. Only apheresis units collected within the specified time interval may be used for component processing.
  6. Donors will be treated for adverse reactions as needed.
  7. All specimens and donor units will be labeled at the donor’s bedside before starting a new donor collection.
  8. Donors will be monitored post-donation for a reasonable interval before discharge.
  9. All processes will be documented in the Hematos blood bank computer system.
  10. All equipment and supplies will be used according to manufacturer’s instructions.
  11. The collection workstation and equipment will be cleaned before starting the next donor.
  12. All policies, processes, and procedures must comply with Qatari, HMC, and applicable accreditation standards (i.e. AABB, CAP, and JCI).

References:

  1. HMC 1001 Setting Specification, Version 1.5, Hematos IIG, Medinfo
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA, October 2013