Like many health systems, WellSpan Health experienced frequent fluctuations in demand for platelet transfusions. Sudden increases required emergency shipments, while decreases led to waste. Lab leadership needed an easier way to ensure the availability of safe platelet transfusions at all times. The Pennsylvania-based integrated health system implemented the Platelet PGD test in 2016 at its largest acute care facility, WellSpan York Hospital. The testing enables the hospital to extend platelets to day six or seven by PGD testing for bacterial contamination. In turn, this extended dating allows the hospital to stabilize inventory and generate cost savings by significantly reducing wastage.

1. Improving Patient Safety, Inventory Management, Quality and Cost Savings
via Verax PGD Testing for Platelets
Michelle Erickson, MD MBA; Lisa Schaeffer, MT(ASCP); Charles J. DiComo, Ph.D.
WellSpan Health York Hospital, Transfusion Services, Blood Bank

2. Blood Product Safety
Bacterial contamination poses the greatest risk in transfusion medicine
 Data indicates current interventions interdict 30-50% of
contaminated platelets
 Platelets are stored at room temperature
 1:2,000 platelets transfused is bacterially contaminated
 Many contaminations are missed due to passive surveillance
 Septic platelet transfusions are the leading cause of fatalities due
to transfusion transmitted infection
 FDA has issued draft guidance that additional steps be taken to
reduce risk, such as pathogen inactivation or rapid testing

3. Septic Reactions: Platelets
 Platelet Contamination
 Many various organisms are implicated in
platelet contamination
 Testing must detect both:
▪ Gram Positive and
▪ Gram Negative organisms
 Clinicians often underappreciate the risk
 For suspected septic reaction, broad antibiotic
coverage must be initiated until the organism is
identified

4. Pathogen Reduction Technology
 A targeted psoralen molecule is added to the
product
 UVA light causing irreversible binding of the
psoralen to DNA/RNA
 Replication is blocked via covalent cross
linkage of nuclear material:
Bacteria, leukocytes, bacteria, parasites,
spirochetes
Reduced risk infection, GVHD
Culture and ZIKA testing not needed
Pan-Genera Detection
 Platelets are bacterially tested using a simple
screening method:
Detects gram negative and gram positive
organisms
Uses conserved antigens for broad detection
Sensitive, simple, rapid onsite testing
Extension of outdate to 7 days with negative
testing as a “safety measure”
 Can be used on many types of platelet
products, including triple apheresis products
 Improves product availability and safety
Methodologies to Reduce Platelet Contamination

5. Methodologies to Reduce Platelet Contamination
Comparisons of Shortcomings:
Pathogen Inactivation Downsides:
 Expensive and less effective product:
 Platelet degradation/loss/dilution
 Lower platelet count increments
 Increases transfusion rates
 Increased platelet refractoriness
 Cannot be used for patients with psoralen
allergies
 Cannot use for neonates needing UV
therapy
 Can only be used for single or double
apheresis products.
 No outdate extension
Verax PGD Testing Downsides
 Few false positives
 May give a false positive if donor breeds rabbits
 Testing needs to be repeated daily at
end of platelet shelf life
 Testing occurs in the blood bank (versus
the blood center)
 Only tests bacterial contaminants

6. Product Eval: Verax PGD testing vs. INTERCEPT Pathogen Inactivation
 Platelet inventory and quality:
 7-day outdate significantly improves inventory
 Reliable supply of quality platelets
 Verax can be used to test platelets from triple product donors
 INTERCEPT product degradation was unacceptable
 Verax maintains product integrity and avoids dilution
 Verax addresses the true risk, which is bacterial contamination
 Contraindications and risks of INTERCEPT products:
 Chemically treated blood products
 Blood bank cannot monitor patients who may have psoralen allergies
 Newborns are frequently require UV therapy
 INTERCEPT causes increased rates of alloimmunization

7. Verax PGD Methodology
 Testing is done within 24 hours
of transfusion after four days of
storage
 A small sample of platelets are
mixed with reagent, mixed and
centrifuged
 The pellet is resuspended, and
treated with two more reagents
The sample is placed on the
indicator plate and results are
displayed after 20 minutes
http://veraxbiomedical.com/products/pgd-technology/

8. Benefits for WellSpan & Our Community
 Improved platelet safety with testing at days five, six and seven
 Better resource management:
 Fewer emergency shipments of platelet products
 Fewer platelet shortages; less platelet rationing
 Reduced postponement of transfusions
 Units shared with other WellSpan entities
 Shared best practices with other regional hospitals
 Validation process, set-up, procedure & policy
 Continued benefit of:
 Single donor platelets (safer than pooled products)
 Double and triple products (based on historical donation patterns)

9. WellSpan Results & Experience
• Very few contra-indications:
• One donor found to be incompatible with Verax (clumping)
• Three cases of BacT/Alert Bacterial Contamination culture negative—false
positive
• One case of Strep viridans contaminant—false negative
• One rabbit hunter
• All platelets are now FDA approved for use with Verax
• Staff technologists indicate tests are easy to perform and can be
done on any shift

10. Supply
• Percentage of platelets transfused past fifth day with Verax = >30%
• New average wastage = ~12% (was at 25%)
• Temporary lack of demand due to changes in cardiac program
• Erratic demand associated with trauma program
• Labor and delivery also driving irregular demand
• WSH can act as a supplier during periods of regional platelet shortage
• Routine stocking of WSH sister hospitals

11. Cost Savings
• Total savings to date > $300,000
• Verax cost ~$25/test, reduced price/kit via GPO
contract with AllSpire Health
• Created revenue code/regulatory guidance to capture
bacterial testing at time of transfusion of Verax tested
platelets = $56.50/each
• Platelets Verax tested day five, six and seven—one
time charge attached to product and billed at
transfusion time, Effective 7/1/2017

12. Questions?
Michelle Erickson, MD MBA; Lisa Schaeffer, MT(ASCP); Charles J. DiComo, Ph.D.
WellSpan Health York Hospital, Transfusion Services, Blood Bank