Writing Documentation for Transfusion Medicine
Category: Administration
Administrative documents, not necessarily technical or medical
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
My Opinion: Separate Transfusion Medicine from the Laboratory and Clinical Departments
This is an update of a previous post.
Transfusion Medicine includes laboratory and non-laboratory functions. The non-laboratory and purely clinical functions are unique and have no analogy within the general laboratory. Likewise, from a clinical department perspective, transfusion medicine is not just a clinical service, but also a laboratory and a drug manufacturing center.
The transfusion service/hospital blood bank laboratory is the closest to a laboratory operation, but there is also component modification and complex manual testing, especially for reference immunohematology testing. The staff must make detailed manual decisions, the errors for which could be life-threatening for the patient.
The blood donor center manufactures a pharmaceutical, i.e. blood components with collection, donor qualification, donor abnormal results review, infectious disease marker testing, component production, and donor immunohematology testing—all subject to Good Manufacturing Practices. Never forget: Blood is a drug!! There is no other part of the clinical services or laboratory that manufactures drugs.
Transfusion Medicine is directly responsible for treatment of critically ill patients. Therapeutic apheresis is essential for organ and stem-cell transplants, nephrology, neurology, etc. No other laboratory section is directly responsible for treatment of critically ill patients. Transfusion Medicine physicians are functioning as intensivists. There is no hiding in the blood bank from clinical medicine.
It may also be an industrial manufacturing plant to extract various blood derivatives (e.g. factor concentrates, albumin, Rh immune globulin, etc.) This is pharmaceutical manufacturing on a large-scale basis. There is medical, technical, and special administrative expertise.
Many functions may operate 24/7.
The unique blend of clinical skills is unlike anything else in the laboratory. Thus, those outside the blood bank may not be familiar enough to decide the best course of action for transfusion medicine or for its operations.
The transfusion medicine physician must make acute, life-threatening decisions unlike anyone else in the laboratory 24/7 at all times. The transfusion medicine physician may be on-call for donor issues and review of complex immunohematology problems to acutely decide which blood component (and phenotype) should be given as well as review all adverse reactions to transfusion. The blood bank technologist is at the cutting edge of the battle with his testing and interpretations. No other area of the laboratory is at such risk for injuring or even killing the patient. There is high stress and burn-out.
I have talked with many blood bankers and many seem to share the exasperation that the laboratory or clinical departments do not understand or appreciate us. Often, the laboratory looks at blood bank testing like that coming off a hematology or chemistry analyzer—although patients rarely would have severe morbidity or mortality like the blood bank from errors in those analyzers.
No laboratory pathologist has the pressure of the blood bank physician on-call. It really is 24/7 and requires a broad, clinical background to make the right decisions. It is very stressful and does not permit a good night’s sleep.
Thus, I make my case to separate us from the laboratory. We can form our own more effective administrative organization and optimize our own planning. Regretfully, I have never experienced or worked in such an administrative structure. I also am a realist that cost-containment nowadays makes it much less likely high administration would permit this change. This will probably never happen during my career.
Finally, Transfusion Medicine is an essential service. Blood components are essential drugs. The operations and staff must be free of political influences. This is a service for the entire region or country like the fire department, civil defense, etc. You are playing with fire when you disturb the blood bank.
Super-Users: Engaging Laboratory Staff in Computer Operations
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:
- Blood Donor Center:
- Administrative Clerk for donor registration, consent, ISBT specimen labels, creation of new donors and patients for validation purposes
- Apheresis/Donor Nurse for donor questionnaire, donor physical examination, and donor collection
- Medical technologist for donor marker testing
- Medical technologists for blood component production including Reveos, Mirasol, platelet additive solution, pooling, and leukodepletion
- Medical technologist for donor immunohematology testing
- Medical technologist for inter-depot transfer of blood components
- Hospital Blood Banks and Transfusion Centers:
- 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.
External Disaster Algorithm
Operational Effects of the COVID Pandemic–My Experience in Qatar
The COVID-19 pandemic imposed new challenges to our system. In general, these could be divided into:
- Decreased donors
- COVID vaccine effects
- Decreased available staff
- Shortages of supplies
- More demands on donor apheresis staff—CCP
- More demands on donor processing staff—CCP
- More demands on hospital transfusion service/blood bank staff—CCP
There were fewer donors in the early phase and the nurses also had to add a large number of donor plasmapheresis collections for COVID convalescent plasma CCP. Still they had to maintain all donor and therapeutic apheresis services with no increase in staff. Although elective procedures had been cancelled, there were still obstetrical, oncologic, and trauma services in full action.
Many of our staff were on leave when the borders were closed. Some had to wait months before they could return to work. Others had COVID-19 infection and were quarantined for several weeks. This further reduced staffing. We could not just hire outside staff since considerable training is involved in these processes.
I dedicated a separate donor collection space for the CCP program away from the regular donors as well as a quarantine processing area. Similarly, the CCP plasma was kept segregated from the regular plasma supply and a specially designed location was identified for release of this product. Working for this program diverted resources from blood collection to this special project, again without increasing resources.
With disruptions to shipments of supplies, including the Reveos whole blood kits and Trima donor apheresis sets, we had to rely on our large in-home inventory until the situation stabilized. We prescreened the CCP donor candidates before we would collect them to avoid wastage of kits.
Fortunately, our throughput was minimally affected because our equipment and processes had always stressed speed. We used single-well NAT testing to minimize the need of additional runs. Also, we used Reveos automated component processing to greatly speed production (one Reveos can process four whole blood units in about 23 minutes or about 12 units in 75 minutes.) One technologist could operate all 4 of our machines simultaneously and perform other tasks while the machines were working.
In the system I developed in Qatar, we could complete processing into components (RBCs, buffy coat platelet pools, leukodepleted plasma), all marker and immunohematology testing, leukoreduction of the pools and RBCs, Mirasol pathogen inactivation, and platelet additive solution in as little as five hours.
In rapid turn-around events, it is most helpful to have a robust blood bank computer system that can scale to the challenge. Also, it must mercilessly enforce all the rules starting with donor qualification, screening, collection through testing and production. At times of emergency, it is difficult to meet Good Manufacturing Processes manually.
I had built parallel separate donor collection, donor processing, and transfusion service/hospital blood bank processes specifically for CCP and had to staff them with available personnel, limited our capability to process regular donors. The blood bank computer software restricted CCP use to designated physicians and transfusing locations. For those interested, there is a separate series of posts about the CCP project and its implementation in the dedicated blood bank Medinfo HIIG.
COVID-19 vaccinations should have minimal effect in donor qualification since mRNA or antigen-based ones do not cause donor deferral. Live attenuated COVID vaccines will defer donors for 2 weeks by current rules—the same as other live vaccines. Donors who had previously received CCP will be deferred for three (3) months after last receiving this product.
In summary, the COVID pandemic reduced staffing and affected donor recruitment. We had production mitigations to maximize throughput. The system was stressed by the reduced staffing and special demands to produce CCP. However, the extent of our automation allowed us to maintain throughput throughout the crisis.
Comments in Medinfo Hematos IIG
This post is the policy for using comments in Medinfo software. A subsequent post will show the process of entering comments.
Principle:
There are several different types of comments in HIIG:
- Donor Global
- Patient Global
- Analytical Comments
- Result Comments
- Contraindication Comments
Global Comments appear on the first main screen of either the donor or patient record. The presence of comments is indicated by a bar at the bottom of the screen (in yellow or blue saying Presence of Comments. Double-clicking opens the list of entered comments.
Examination/Results Comments appear only when you open the result to which it is attached. You must know in advance to which result they are linked to find them.
Contraindication Comments appear when entering a donor deferral code
At HMC, we will enter examination/results comments again as global comments (donor or patient) so it is easy for staff to retrieve them and see them with all other comments. You can do this by cut and paste.
Physicians may enter any of these comment types. Comments may be entered before or after a test is authorized/verified. If entered after authorization, the test must be modified to accept the comment and require a special password (not the user sign-into HIIG). Only results/examination comments are visible in the patient’s medical record. Global, analysis, and contraindication comments are visible only in HIIG! Donor comments are only visible in HIIG.
The presence of comments documents physician review of abnormal results as required by the various accreditation standards.
Policy:
- Only designated staff may enter comments.
- Comments entered after authorization/verification of results will modify the donor/patient record and require a special, high-level password distinctly different from the normal user password.
- Enter comments in the following situations:
- Telephone call documentation (e.g. critical values).
- Interpretations of donor or patient test results, transfusion reactions, etc.
- Instructions for the selection of specific and/or modified blood components
- Donor eligibility issues (e.g. donor marker testing abnormalities and disposition)
- Donor reactions
- Donor counseling documentation (e.g. donor counseled at 0930 on 24/3/14 about his abnormal result).
- Any special instructions to staff
- Any other situation where the transfusion physician/supervisor or designate determines it is desirable to enter a comment
- Copy all results/examination-comments and also enter then as global comments against the patient or donor record as applicable.
References:
- Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
- Workflows 1001-1005, Medinfo Hematos IIG, 2013-2014.
Training and Competency Assessment for Blood Transporters
This is a competency assessment for non-physician, non-nursing staff to transport blood from the hospital transfusion services/blood bank to the emergency department and operating rooms. This was designed by my Quality Manager, Ms. Edith Durante.
Sample Document Control Specifications
Below is a sample document specification for a document control process. It was originally designed but never implemented due to changes in the administrative structure in that organization. I want to thank Ms. Editha Durante, Quality Manager for preparing this.
