Category: Blood Bank IT

Includes all areas: Donor, patient, marker testing, component preparation

Processes and Software Building 41: Off-Line Medinfo Donor Transactions

drzeyd

Principle:

Normally, outside donor campaigns still connect to the main server via wireless 4G/5G with a VPN.  However, if there is a “dead” spot, Medinfo can provide a local area network using one of the PCs/laptops to serve as a server.  The local server receives an uploaded image of the donor database.  Upon return to the donor center, the local server’s data is uploaded and synchronized.

When you cannot establish a direct link to the live Medinfo program, you must arrange for Medinfo/VHT to create a local server that will have the current Medinfo donor database for use at outside campaigns where the internet connection cannot be used.  This can also be used if for some reason the Blood Donor Center link is down in order to register donors and check the donor deferral database.

Policy:

  1. For each outside campaign, there should be a pre-campaign visit to verify the availability of internet to connect to Medinfo.
    1. If the internet connection is working, use Medinfo using the 4G/5G access points.  Otherwise:
    2. If none, inform Medinfo/VHT to prepare a local server—at least ONE DAY in advance of the campaign.
      1. Provide Medinfo/VHT one of the portable computers to download the database and software.  This will be the offline server for the campaign.
      2. Link the offline server to the other portable computers for the campaign (see the corresponding Medinfo job aid).
      3. Use the local network (offline server and other portable computers) for registering donors.
      4. Upon return to the Blood Donor Center, upload the data as indicated in the Medinfo job aid.
      5. Continue the regular processes after uploading.

7/9/20

Processes and Software Building 40: Reveos Detailed Settings

drzeyd

A major advantage in using a specific blood bank computer software is to enforce the Good Manufacturing Processes.  Medinfo is merciless:  there are no exceptions without authorization and that is restricted by the security policies.

The following tables show the values established at HMC Doha during my tenure.  These values were recommended by the Terumo BCT Reveos engineer after his direct, hands-on set-up of the equipment.

The minimum and maximum volumes for platelets are specifically designed to work for pooling the buffy coats before Mirasol pathogen inactivation.  There are different settings for platelets suspended in plasma versus those suspended in platelet additive solution PAS.

Similarly, there are specific volume ranges for plasma so that pathogen inactivation can be performed according to Terumo BCT recommendations.

To Be Continued:  4/9/20

Processing and Software Building 39: Atreus and Reveos

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Automated component processing is an almost hands-free separation of into packed RBCs (ready for leukodepletion), buffy coat platelets (ready for pooling), leukodepleted plasma, and a residual buffy coat.  The older Atreus device takes about 10 minutes for one whole blood unit whereas the newer Reveos device needs slightly more than 20 minutes to process four whole blood units.  At the end of processing:

  1. RBCs are ready for leukodepletion using the integral filter provided with the kit.
  2. Plasma is ready for pathogen-inactivation and freezing.
  3. Buffy coat platelets are ready for pooling using the Platelet Yield Index PYI.
    1. Further processing (filtration and Mirasol treatment) occurs if the donor marker testing results pass
  4. Residual buffy coat is not a clinical product but may be used for quality control for stem cell processing and/or cell line expansion

The process in Medinfo is as follows:

  1. Receive the whole blood units for processing by reading the ISBT specimen barcode.
  2. Collection data (volume, time to complete collection, time of collection, etc.) is transferred to the component processor.
  3. Select the processing machine:  Atreus vs. Reveos
  4. Select the protocol:  2C (RBCs and plasma) versus 3C (RBCs, platelets, and plasma)
  5. Further processing as per the flow diagrams.

At HMC Doha, Medinfo developed the first bidirectional interfaces to both Reveos and Atreus.

To Be Continued

2/9/20

Processes and Software Building 38: Component Processing Overview

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As with each major area of Transfusion Medicine, a current state is captured.  From this, a future state overview is then developed.

At this time, the client should study his current state and the future state and see how he can bolster the critical control points and build them into the processes.

In this series of posts, we will consider:

  1. Component production by Reveos automated component processing
  2. Component production by Atreus automated component processing—replaced by Reveos
  3. Manual component processing
  4. RBC leukodepletion
  5. Platelet pooling
  6. Mirasol pathogen inactivation for platelets and plasma
  7. Platelet production with platelet additive solution PAS
  8. Cryoprecipitate and cryo-poor plasma production
  9. Labelling

The example of current and future state shown is what Medinfo and I built for HMC Doha:

To Be Continued

1/9/20

Processes and Software Building 37: Donor Marker Testing–Final Comments

drzeyd

This series of the processes for donor marker testing has demonstrated the complexity and flexibility of designing processes.  In Medinfo, you can custom-design the criteria based on your local, national, and international requirements.  The end-user client must specify what he wants, and I reiterate:  Be careful what you ask for, you may get it.  Seek assistance if you are uncertain of what to use.

My criteria were based on several international standards, e.g. AABB, US FDA, CE, and Australian.  I strongly recommend you start with a set of standards and localize it for your needs.

For example, US FDA/AABB do not have a screening criteria for brucellosis since it is rare in their jurisdiction.  However, it is relatively common in the Middle East so I added a donor screening question for it.  International AABB does allow for variance with US FDA criteria so if you are outside the USA, embrace this.  The advantage of customizable software allows you do localize it to your needs.  A turnkey system, e.g. from the USA, may not allow such changes.

Finally, there are emerging pathogens that are constantly changing the donor criteria (e.g. SARS-CoV-2, MERS, SARS, Zika).  The software must be robust and allow rapid alteration to meet new donor screening criteria.  This is a constant uphill battle and requires a lot of time to keep up and validate any changes.

Complete Interim Policy on Marker Testing

For your reference, the following is the complete set of marker testing algorithms I used just before I left HMC Doha:

Definitions:

Positive result for EIA means S/CO ratio >= 1.0

Positive result for LIA means particular pattern of bands as defined by the manufacturer

Indeterminate result for LIA means presence of bands not meeting positive criteria

  1. Hepatitis B:
    1. HBsAg non-negative, then:
      1. HBsAg positive with HBsAg confirmatory positive, regardless of other results:  permanent deferral, refer to Infectious Disease clinic
      2. HBsAg positive with HBsAg confirmatory borderline or negative, repeat all HBV testing after 8 weeks
      3. HBsAg borderline:  repeat all HBV testing after 8 weeks
      4. HBV-DNA positive confirmed, regardless of other results:  permanent deferral, refer to Infectious Disease clinic
    2. If HBcAb positive, repeat after 8 weeks
    3. Repeat Hepatitis B Testing After 8 weeks:
      1. HBsAg positive with HBsAg confirmatory positive:  permanent deferral, refer to Infectious Disease clinic
      2. HBsAg positive with HBsAg confirmatory borderline or negative:  permanent deferral, refer to Infectious Disease clinic
      3. HBsAg borderline, permanent deferral, refer to Infectious Disease clinic
      4. HBV-DNA positive confirmed:  permanent deferral, refer to Infectious Disease clinic
      5. HBcAb positive or borderline with negative HBsAg and negative HBV-DNA:  review HBsAb level:
        1. If HBsAb level >= 100 mIU/mL (100 IU/L), donor may be reentered
        2. If HBsAb level < 100, then recommend to donor to receive booster HBV vaccine
          1. After HBV vaccine administration, retest after 30 days:
            1. If HBsAb level >= 100, donor may be reentered
            2. If HBsAb level < 100, donor is indefinitely deferred
      6. HBsAg, HBcAb, HBsAb all negative:  reenter into donor pool
  • Hepatitis C:
    • HCV-RNA positive confirmed, regardless of other HCV results:  permanent deferral, refer to Infectious Disease clinic
    • HCV-RNA borderline:  repeat all HCV testing after 6 months
    • HCV-InnoLIA positive, regardless of other HCV results:  permanent deferral, refer to Infectious Disease clinic
    • HCV-InnoLIA indeterminate:  repeat all HCV testing after 6 months
    • HCV-Ab positive, HCV-RNA negative, do HCV-InnoLIA:
      • If HCV-InnoLIA positive, permanent deferral, refer to Infectious Disease clinic
      • If HCV-InnoLIA indeterminate or negative, repeat all HCV testing after 6 months
    • Repeat Hepatitis C Testing After 6 months:
      • HCV-RNA or HCV-InnoLIA positive:  permanent deferral, refer to Infectious Disease clinic
      • HCV-RNA or HCV-InnoLIA borderline:  permanent deferral, HCV infection not confirmed
      • HCV-Ab positive or borderline without positive HCV-RNA or positive HCV-InnoLIA:  permanent deferral, HCV infection not confirmed
      • HCV-Ab negative, HCV-RNA negative, HCV-InnoLIA negative:  reenter donor into donor pool
  • HIV Testing:
    • HIV-RNA positive confirmed, regardless of other HIV results:  permanent deferral and do HIV-InnoLIA, refer to Infectious Disease clinic
    • HIV-RNA borderline:  do HIV-InnoLIA
    • HIV-InnoLIA positive, regardless of other HIV results:  refer to Infectious Disease clinic
    • HIV-InnoLIA indeterminate:  repeat all HIV testing after 8 weeks
    • HIV Ab positive with negative HIV-RNA and/or borderline/negative HIV-InnoLIA:  repeat testing after 8 weeks
    • Repeat HIV Testing After 8 Weeks:
      • HIV RNA positive and/or HIV-InnoLIA positive, regardless of other HIV results:  refer to Infectious Disease clinic
      • HIV-InnoLIA and/or HIV antibodies indeterminate:  permanent deferral, HIV infection not confirmed
      • HIV Ab negative and HIV-RNA negative and HIV-InnoLIA negative:  reenter into donor pool
  • HTLV 1/2 Testing:
    • HTLV Antibodies positive, then do HTLV-InnoLIA:
      • HTLV InnoLIA positive for HTLV-1 and/or HTLV-2:  refer to Infectious Disease clinic
      • HTLV InnoLIA indeterminate or negative, repeat HTLV Ab and HTLV InnoLIA testing after 6 months
    • Repeat HTLV Testing After 6 Months:
      • HTLV 1/2 antibodies positive, permanent deferral and do HTLV InnoLIA
      • HTLV 1/2 antibodies indeterminate,  permanent deferral and do HTLV InnoLIA
      • HTLV InnoLIA positive for HTLV-1 or HTLV-2: refer to Infectious Disease clinic
      • HTLV InnoLIA indeterminate, donor permanently deferred.
        • Issue letter HTLV-Not Confirmed
      • HTLV 1/2 Ab negative and HTLV InnoLIA negative, reenter donor.
  • Malaria Testing:
    • Defer donor if he has been in malarial endemic zone within the past 3 months
    • If travel to malarial zone > 3 months, do malarial antibody testing:
      • Malaria antibody negative:  no deferral
      • Malaria antibody positive, perform malarial antigen test:
        • Malaria antigen test positive, refer to Infectious Disease clinic—defer until 3 years after cessation of treatment
        • Malaria antigen test negative:
          • Plasma may be collected
          • RBCs and platelets must be destroyed.
        • Repeat malarial antibodies after 3 years:
          • If malarial antibody test positive, donor must not be used for RBC components but may be used for plasma production
          • If malarial antibody test negative, reenter donor for all components
    • Defer donor if he has received malarial treatment (not prophylaxis) for 3 years
      • Perform both malarial antibody and antigen testing:
        • Defer based on section 5.2
  • Syphilis Testing:
    • Syphilis Ab test positive or indeterminate:  do InnoLIA-Syphilis test
      • InnoLIA-Syphilis test positive:  permanent deferral, refer to Infectious Disease clinic
      • InnoLIA-Syphilis test borderline or negative:  defer for 1 year, then repeat all syphilis testing.
    • Repeat Syphilis Testing after 1 Year:
      • Syphilis antibody testing negative, reenter into donor pool
      • Syphilis antibody positive or borderline:  do InnoLIA-Syphilis test
        • InnoLIA-Syphilis test positive:  permanent deferral, refer to Infectious Disease clinic
        • If InnoLIA-Syphilis borderline or negative:  permanent deferral, syphilis not confirmed

References:

  1. Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria, Guidance for the Industry, US Department of Health and Human Services, FDA, Center for Biologics Evaluation and Research CBER, April, 2020
  2. Use of Serologic Tests to Reduce the Risk of Transfusion-Transmitted Human T-Cell Lymphotropic Viruses Types I and II, Final Guidance for Industry, February 2020
  3. Draft Guidance for Industry:  Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II), CBER, September 2018
  4. Guidance for Industry:  Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry, US Department of Health and Human Services, Center for Biologics Evaluation and Research CBER, May 2010
  5. Guidance for Industry:  Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc), US Department of Health and Human Services, Center for Biologics Evaluation and Research CBER, May 2010
  6. Product inserts, InnoLIA-Syphilis/HCV/HIV/HTLV, Immunogenetics, Singapore
  7. Malaria Section, Australian Red Cross brochure, 2007

25/8/20

Processes and Software Building 36: Donor Nucleic Acid Testing

drzeyd

In Medinfo, criteria for donor screening may be based on one test (e.g. Hgb), a group of tests taken together (HBsAg, HBcAb, HBsAb), or separate sets of donor testing criteria.  Nucleic Acid Testing NAT is considered separate from the EIA, LIA, and Ag tests.  In any case, when there is a combination of both acceptable and deferrable results, the longest deferral is applied as the deferral or contraindication, e.g. a temporary deferral is replaced by a permanent deferral.

Our NAT testing at HMC Doha consisted of a combination combo test.  If this was non-negative, then individual HIV 1-2, HCV, and HBV NAT testing were performed.  For speed, we used single-well testing for each donor.  However, it is very easy to build pooling into the algorithm if that is preferred by the client:

To Be Continued:

24/8/20

Processes and Software Building 35: Donor Malaria Test Screening

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Processes and Software Building—Part 35:

Malaria Testing Donor Screening Process

Zeyd Merenkov, MD, FCAP, FASCP

Independent Consultant in Transfusion Medicine and Information Technology

The malaria screening varies considerably by country.  I chose for Qatar to follow a combination of WHO and Australian guidelines as per the attached criteria.  We used a malaria antibody screen and malaria antigen test.  There are many alternate approaches, including using a malaria NAT.  The actual specification was:

  1. Malaria Testing:
    1. Defer donor if he has been in malarial endemic zone within the past 3 months
    2. If travel to malarial zone > 3 months, do malarial antibody testing:
      1. Malaria antibody negative:  no deferral
      2. Malaria antibody positive, perform malarial antigen test:
        1. Malaria antigen test positive, refer to Infectious Disease clinic—defer until 3 years after cessation of treatment
        2. Malaria antigen test negative:
          1. Plasma may be collected
          2. RBCs and platelets must be destroyed.
        3. Repeat malarial antibodies after 3 years:
          1. If malarial antibody test positive, donor must not be used for RBC components but may be used for plasma production
          2. If malarial antibody test negative, reenter donor for all components
    3. Defer donor if he has received malarial treatment (not prophylaxis) for 3 years
      1. After 3 years, perform both malarial antibody and antigen testing:
        1. Defer based on section 5.2

The Medinfo testing algorithm follows:

To Be Continued:

22/8/20

Processes and Software Building 34: Donor Syphilis Testing

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Syphilis testing uses a screening test (we used an EIA methodology to detect cardiolipin) and a confirmatory test a syphilis linear immunoblot assay LIA.

I emphasize that any test methodologies and testing algorithms can be designed in Medinfo.  This is what I selected during the time I was HMC Doha.

My algorithm specification was:

  1. Syphilis Testing:
    1. Syphilis Ab test positive or indeterminate:  do InnoLIA-Syphilis test
      1. InnoLIA-Syphilis test positive:  permanent deferral, refer to Infectious Disease clinic
    2. InnoLIA-Syphilis test borderline or negative:  defer for 1 year, then repeat all syphilis testing.
    3. Repeat Syphilis Testing after 1 Year:
      1. Syphilis antibody testing negative, reenter into donor pool
      2. Syphilis antibody positive or borderline:  do InnoLIA-Syphilis test
        1. InnoLIA-Syphilis test positive:  permanent deferral, refer to Infectious Disease clinic
        2. If InnoLIA-Syphilis borderline or negative:  permanent deferral, syphilis not confirmed

This was translated into Medinfo processes as follows:

To Be Continued:

21/8/20

Laboratory Data Analyst

drzeyd

This is an updated job description of what I used at NGHA Riyadh for a Systems Administrator for laboratory software. Such a person will have software privileges as agreed by the hospital information systems department. In our system there, there was a separate laboratory information systems section LIS:

Basic Function:

To analyze laboratory databases and prepare reports to optimize laboratory utilization and management

Principal Duties:

  1. Maintains and secures the laboratory information server (to be distinguished from the LIS hardware) and its associated databases
  2. Uses downloaded database files from laboratory computer system to prepare reports as deemed necessary by and as prioritized by the Pathology Chairman, Laboratory Operations Administrator, and/or Portfolio Head, LIS, which may include but is not limited to:
    1. Cost containment (implementation of CEO directives)
    2. Internal laboratory and external hospital committees (as requested by them)
    3. OVA statistical analysis
    4. Specimen referrals to outside laboratories
    5. Specimen referrals from other hospitals or hospital systems
    6. ER Stat Laboratory utilization reports
    7. Laboratory Utilization Committee, including STAT turn-around-time and critical values
    8. Quality Improvement-Accreditation Portfolio
    9. Test utilization metrics
    10. Any other reports requested/approved by the Portfolio, LIS, Laboratory Operations Administrator, and/or Chairman
  3. Assists in the management of the document control program for the laboratory
  4. Assists in the management of the intellectual property control program for the laboratory
  5. Performs any other assignments as directed by the Pathology Chairman, Laboratory Operation Administrator, and/or Portfolio Head, LIS

Essential & Preferred Education & Experience:

  1. B.S. degree or higher in computer science including coursework in networking, database structure, and management
  2. Experience (at least two years) in operating enterprise-level (e.g. Oracle, IBM DB2), business-level (Postgresql, MySQL, Microsoft SQL Server) databases as well as Microsoft Access® desirable
  3. Fluency in English (high-level) essential, fluency in Arabic desirable
  4. Experience (at least one year) in working with databases in a variety of operating systems (Win32/64, Linux, UNIX) desirable
  5. Experience (at least one year) in working in a hospital laboratory environment desirable, not necessarily as a laboratory technologistLa
  6. Must be self-reliant and disciplined to operate independently and have excellent organizational and interpersonal skills to relate to a wide variety of laboratory and hospital personnel

Degree of Responsibility:

This is a middle-level management position within the Department of Pathology and Laboratory Medicine.  The analyst must be self-reliant and disciplined to operate independently, have excellent organizational and interpersonal skills to relate to a wide variety of laboratory and hospital personnel.

18/8/20

Whole Blood

drzeyd

In my long career, there have been cycles in transfusion practice.  Today’s dogma becomes yesterday’s heresy and then later again the dogma.  Just consider the selection of blood components before the introduction of cyclosporine for intended renal transplant recipients.

In training, I was told NEVER, NEVER use the intended donor’s blood for the renal recipient.  This would immunize him against the donor tissue antigens and cause the transplant to fail.

Several years later after cyclosporine, we were doing a booming business of directed RBC transfusions from the donor to his/her recipient.

Just a few years ago, I used blood component therapy for all, especially trauma patients.  Give the victim what he lacks:  for oxygen-carrying capacity, RBCs;  for volume crystalloid;  for low protein albumin;  for coagulopathy FFP, factor concentrates, cryoprecipitate;  for thrombocytopenia, platelets.

Most recent studies now mention the danger of giving too much crystalloid, etc.  It talks about using fresh whole blood to provide all of the above in less volume.  Results from trauma and military studies are encouraging and may be better than individual component therapy.

There are special considerations for whole blood:

  1. 21-day outdate for the RBCs
  2. Platelet functionality limited after 7 days
  3. Use of group O, low-ABO-titer

Pathogen-inactivation of whole blood is CE-approved by riboflavin (Mirasol).  Terumo BCT is developing an exciting technology to first use Mirasol and then make components using the Reveos automated component system—RBCs, plasma, and platelets.  This is an ongoing project so for now the only CE-approved project is use as whole blood.  Such Mirasol-treated whole blood has been shown to prevent malaria transmission in Ghana.

From my review of the literature, these are my specifications as of this date 18/8/20:

  1. Use/ordering restricted to trauma and selected ICU/surgery suites
  2. Only male donors
  3. 7 day outdate
  4. Group O, Anti-A and anti-B IgM titers, both <= 1/256
  5. Leukodepleted < 1E6 residual WBCs

What level of anti-A and anti-B titers is acceptable?  The titer was set as low as 1:32 but at recent THOR meeting 1:256 has been used.  In Qatar in a pilot study, I found that about 50% of our donors had titers < 1:256.  The issue is that each time the donor presents himself/herself, we must repeat the titer—it is not stable.

Of course, performing even just a saline-titer is time consuming.  The only practical way for us in Doha would have been to use an automated titration option on an immunohematology analyzer—in our case, the Ortho Vision MAX, which could perform 1 titration run in about 30 minutes, and the instrument cannot be used for any other testing during the process.

I personally would perform leukodepletion to conform to CE, but you need a special whole blood filter that removes WBCs but spares the platelets.  Terumo BCT has such a filter that achieves <1E6 residual WBCs.  Never use a standard RBC leukodepletion filter since it will remove BOTH platelets and WBCs—this would defeat the purpose of using whole blood.

At HMC Doha, female donors were only used for packed RBC production—all plasma and platelets were discarded.  Some centers do HLA antibody screens and allow negative females to donate.

Finally, many groups do not leukodeplete at all.  I am concerned about the risk of adverse reactions and TRALI so I would conform to CE and do it.

Whichever conditions you stipulate, it is easy to create the process in Medinfo.  The most important thing is to know what you want to specify.

19/8/20