Time: Appreciating Testing and Component Release Times

This is a revised version of a previous post.

I have had many medical students, residents, and fellows rotate through my Transfusion Medicine section.  Hardly anyone has any interest in making my discipline his/her career.  It is a required rotation or an “easy” rotation during which the trainee may take his vacation.  The trainee will cram for the examination and then promptly forget it.

I left practice in the USA in 1990, in what I consider the golden age of laboratory medicine.  We had supervisors for each laboratory section.  In the blood bank, we had many staff with SBBs or who were SBB students.  We were very self-sufficient in handling immunohematology problems except for rare blood types or antibodies to high incidence/prevalence antigens.

When I returned to visit my old laboratory, I sensed a deprofessionalization of the laboratory and blood bank in particular.  Blood Bank now is a cost center, not an area of revenue.  Why hire experienced blood bankers for most hospitals?  Send the antibody workups to the Blood Center.  There are limited jobs for transfusion medicine consultants.  Minimize testing, don’t do extended antigen typings, etc.

Nowadays, I feel like one of the dinosaurs marching into oblivion like in Walt Disney’s Fantasia film, the section called The Rite of Spring.  Who will replace those retiring?  Have you ever noted the average age of attendees at the AABB annual convention?  I feel young when I go there (and don’t worry about the gray hair!)

I want to attract new doctors and scientists to Transfusion Medicine.  I really try, but most have no interest and look on their rotations as a necessary evil.

I have lowered my expectations for most medical trainees in Transfusion Medicine.  They don’t like it, they just want to pass it, and move on.  What must I impress them with for their future careers?  What is essential for them to remember?

I have had both pathology and non-pathology trainees.  Surgical and ob/gyn doctors used to spend one month whereas the hematology and pathology residents/fellows spent on average three months.  The few interested in the field might do multiple rotations.

I still gave them lectures on a variety of topics, especially how to transfuse blood components, basic ABO/Rh antigens, compatibility testing, and direct antiglobulin testing.  They would forget most of this, but I wanted them to remember TURN-AROUND-TIMES:

Examples:

HOW LONG DOES IT TAKE TO PERFORM THE TEST?  TO FIND COMPATIBLE BLOOD?  TO THAW THE PLASMA?  RELEASE AN MTP SHIPMENT?  TO PERFORM A TRANSFUSION REACTION WORKUP BEFORE RELEASING MORE BLOOD?

I am not discouraging people from entering the field, but I am a realist to know that few will share my passion for serology or want to take call on difficult immunohematology cases.  At least if they understand the pressure the technical staff are in and these turn-around-times this will make both their work as clinicians and mine as transfusion medicine more congenial.

Anecdotes: Outside Software Consultants

Sometimes, you may not have adequate resources for a project so you will consider hiring an outside consultant.  During my career, I have used several outside consultants for projects ranging from installing a new general laboratory computer system to assisting in getting international accreditations.

Regrettably, my experience with software consultants has been mixed.  I have used them for general laboratory software installation and settings.  Very few have any experience with dedicated blood bank software or setting up hospital blood bank modules.  They are often former employees of the software vendor you are using.  There is always a potential for conflict of interest.

The software consultant must work for you, NOT for the vendor you are using.  He/she must maintain his independence from the vendor and only represent your interests.  I have had many problems with this.  Here are some of my unpleasant experiences:

Current and Future States:

One set of consultants gave essentially the following current state mapping for almost every test in our menu:

  • Order this.
  • Collect this.
  • Receive this.
  • Perform this.
  • Release this.

They did not know our current state so they were unable to help us build a proper future state.

Mapping Errors:

The consultants were in charge of exporting results from a previous system into the new one, this included mapping the results into the appropriate test fields.  They assumed it would map properly, I insisted on testing a two-week sample of laboratory results and discovered major errors that could adversely affect patient care—it was a major disaster and almost held up implementing a hospital go-live on-time.

Benefits of New Software:

The consultants were obsessed with calculating benefits of the conversion to the new software vendor and making fancy PowerPoint presentations to assure officials that they were gaining benefits.  There were many issues to resolve that were critical to the functionality that I felt the time would have been better spent in fixing the software issues than calculating alleged benefits.

The Need for Speed:

There were some consultants without any experience in blood bank who insisted that this had no bearing in making software settings.  One bragged to me that he could install a blood bank system in a few days.

Default Settings:

Some outside consultants kept pushing using the default settings.  There is no “one size fits all” solution for a large healthcare organization.  There is need for customization.  I wondered why we needed the consultants to set up default settings which is what the vendor wanted us to do anyway.

Opinion: Outside Accreditation and Quality Consultants

Sometimes, you may not have adequate resources for a project so you will consider hiring an outside consultant.  During my career, I have used several outside consultants for projects ranging from installing a new general laboratory computer system to assisting in getting international accreditations.

For a complex accreditation process such as AABB, I have used such consultants to audit operations in the donor center including processing and testing, hospital blood banks, and stem cell laboratory.  They are high-level technical specialists with highest blood bank qualifications (e.g. SBB(ASCP) or equivalent) and have considerable experience in practice of blood banking and quality systems.  They have been AABB Assessors so they can give you a dry-run accreditation assessment.

Depending on the project, you may need one or a group of consultants.  I have worked with both individual consultants and groups.  A group can complete the tasks quicker but this is not always necessary.  Organizations such as AABB have many different consultants with different types of expertise so you can select the most appropriate individuals to form a team for your needs.

These specialists can audit your operations and propose a model and if you want, actually help you to implement the processes.  They can help you with the accreditation formalities, especially if you do not have any staff with experience in the process.  It all depends how much you can spend.

In the Middle East, to bring in such consultants may mean expensive air fares, hotels, meals, plus the actual costs of doing the consulting.  This is a major investment for your organization but it is well worth it to expedite the process.  There are local consultants available as well and using them may greatly help with the expenses.

Although it is expensive upfront, it can be cheaper in the long run by establishing the appropriate framework in the first place.  You can engage the consultants to actually do much of the work themselves, but it is better for them to offer a train the trainer experience, i.e. engage your own technical staff to learn new skills and then have them cross-train the rest of the staff. 

Based on the findings, your local staff can implement the changes.  You can then consider rehiring the consultants to verify that the work has been done properly.

I have used both individual consultants and groups through AABB Consulting.  My staff and I have learned much from such interactions, and I highly recommend their use when local expertise is not available.

Processes and Software Building 4: Super Users

Super-Users:  Engaging Laboratory Staff in Computer Operations

This is an update of a previous post.

It is critical to engage the technical, medical , and (blood bank) nursing staff in this process,  That is why it is so important to identify a core of computer-literate users to help with the building and testing/validation.

I don’t mean finding staff who can already program or code.  Rather, I mean staff that are astute with knowing their work processes and who had good skills with Microsoft Office and Windows or equivalent.  I did not expect them to understand database structure or use structured query language.  They were chosen for their ability to learn quickly and their meticulousness.

For our blood bank system, I chose computer-literate technical staff to be involved in the build from the very beginning.  They learned how to test each module and to some degree support it.  These became my Super-Users and to this day support the system for many tasks.  These staff served as the system administrators and worked directly with me as the Division Head for Laboratory Information Systems.  They were not full-time and still had their other clinical/technical duties.  They liaised with the software vendors engineers.

Our blood bank system was NOT a turnkey system.  It was custom designed according to our workflows.  There were NO default settings!!  We had to be remember, ‘Be careful what you ask for, you might get it!’  In some countries, approved systems are turnkey and may allow only few changes to the core structure and thus may not be this optimized for the needed workflow;  often only cosmetic changes are permitted.

When we built our first dedicated blood bank computer system, the company would take a module and completely map out the current processes collaboratively with me.  After this, I analyzed the critical control points and started to map out the improved computer processes that would take over.  After that we would build that those processes in the software and test it.  If it failed, we would correct it and test again…and again if necessary.  Fortunately, the blood bank vendor did not charge us when we made mistakes.

Sadly, another vendor (non-blood bank), only gave limited opportunities to make settings.  If wrong, there might be additional charges to make corrections.  This other vendor really pushed the client to accept the default settings regardless whether or not they actually fit.  End-users were selected to make and approve the settings, but they were only minimally trained on how to make the settings.  It was a journey of the end-users being led to the slaughter—and being blamed for their settings when they accepted the vendor’s recommendations—they usually selected the defaults.  There wasn’t enough time for trial and error and correction.

The blood bank system Super Users were an important part of our process.  They were an integral part of the implement team and could propose workflows, changes, etc.—subject to my approval.  They learned the system from the start and developed invaluable skills that allowed them to support the system after the build.  Also, they could serve to validate the system according to the protocols I prepared.  Moreover, I took responsibilities for their activities and they were not left out to hang.

Every hospital blood bank location and the blood donor center had Super-Users.  These included:

  1. Blood Donor Center:
    1. Administrative Clerk for donor registration, consent, ISBT specimen labels, creation of new donors and patients for validation purposes
    1. Apheresis/Donor Nurse for donor questionnaire, donor physical examination, and donor collection
    1. Medical technologist for donor marker testing
    1. Medical technologists for blood component production including Reveos, Mirasol, platelet additive solution, pooling, and leukodepletion
    1. Medical technologist for donor immunohematology testing
    1. Medical technologist for inter-depot transfer of blood components
  2. Hospital Blood Banks and Transfusion Centers:
    1. At least one technologist at each site for inter-depot transfer, component medication (washing, irradiating, aliquoting, reconstituted whole blood), immunohematology testing, component allocation and release

The cost of using these staff?  They were paid overtime and were relieved of other duties when working on Super User duties.  This was much cheaper than hiring outside consultants who may or may not know our system well enough to perform these tasks.

By having a Super User at each site, I in effect had an immediate local contact person for troubleshooting problems who could work with the technical/nursing staff.  We did not rely on the corporate IT department for support and worked directly with the software vendor.  Response time was excellent this way.

The following document is a sample document of the assigned Super User duties during a validation.

Donor Recruitment and Campaigns Policy

5.0 Donor Recruitment and Campaigns Policy

Policy:

  1. All policies, processes, and procedures must comply with local, national, and applicable international accreditation standards (i.e. AABB, CAP, ISO, and JCI).
  2. All recruitment information must be entered into Hematos IIG.
  3. The Coordinator, Donor Affairs, is responsible for all recruitment activities.
  4. Donor recruitment staff will visit scheduled donation sites in advance and assess their suitability and prepare them for use before the start of each campaign.
  5. Donor recruitment materials and announcements will be left at each location during the inspection visit.
  6. Collected blood will be stored at room temperature during the collection on-site and transported back to the Donor Center in suitable validated containers to maintain storage at desirable temperature.
  7. The processes and procedures for normal donation, e.g. registration, donor questionnaire, physical examination, and collection apply.

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

Service Level Agreement Example

At HMC Doha, I used service level agreements SLA to specifically define responsibilities in a contract for service between various entities including:

  • Transfusion Medicine and outside clients (blood components and transfusion testing)
  • Transfusion Medicine and HMC departments outside blood bank (e.g. operating theatres, liver transplant, trauma, etc.)
  • Blood Donor Center and HMC hospital blood banks

The following is a sample of a previous SLA between the Transfusion Medicine Division and one of HMC’s hospital’s operating theatres.

Summary of Accomplishments at Hamad Medical Corporation 2011-2020

2011

Established automated component production using Atreus technology, plasma and platelet pathogen inactivation (Mirasol)—made HMC component production Good Manufacturing System GMP compliant

2011

Qatar is the first to adopt non-PCR-based NAT technology (Grifols/Novartis Tigress) and becomes world reference site for this

2011

Based on the above, Qatar can now completely process all whole blood into blood components (red cells, platelets, and plasma) in as little as 5 hours from collection!

2011-2020:

I established policies and procedures for the hospital blood banks/transfusion services, blood donor center, therapeutic apheresis, and laboratory information systems to bring HMC in compliance with the Council of Europe, international AABB, and other standards.  I customized our own standards for our local needs based on them.

2012-2013

Implemented custom build of the multilingual blood bank computer system (Medinfo) for both patient and donor services, including development of interfaces to all production equipment including Atreus and Mirasol (world’s first) and a direct link to Ministry of the Interior to obtain patient demographics in English and Arabic—Qatar became the world’s first site to combine fully-interfaced, automated component production with pathogen inactivation:  Qatar becomes world reference site for this.

2013-2014

Built, validated, and implemented laboratory build of hospital information system, Cerner Millennium

2015

Replaced and updated Atreus with Reveos automated component production to allow faster throughput and capacity with a full bidirectional interface (world’s first), introduced platelet

additive solution PAS with pathogen inactivation (Mirasol)—Medinfo interfaces updated to Reveos for all equipment:  this doubles the capacity to process whole blood into components using the same physical space

2015-2019

Updated dedicated blood bank software Medinfo Hematos IIG by several versions using Division Head, LIS, and internally trained Super Users—at great cost savings to HMC by not using outside consultants (e.g. Dell Consulting)

2019

Established column absorption technology using Terumo Optia therapeutic apheresis machine for treatment of ABO-incompatible renal transplants:  I validated using the Ortho Vision MAX to perform ABO antibody titers for this system and correlated it with the reference method at Karolinska Institutet in Stockholm (manual gel) to bring rapid throughput and labor savings—Qatar being the first-site in the world to do this.  We saved money by using the same apheresis machine to use this column absorption technology (no need for second machine to use the columns)

2020

Expedited setup (two weeks total) of COVID-19 convalescent plasma production, initially manual and then fully integrated into the Medinfo computer system as a customized module with separate quarantine collection, production, and transfusion service functions

Other:

I was awarded two HMC Star of Excellence Awards:

2013—Liver Transplantation Transfusion Support

2019—ABO-Incompatible Renal Transplantation Support