Verax PGD testing improves patient safety and reduces costs by screening platelet products for bacterial contamination beyond the standard 5-day expiration date. Platelets are at high risk for bacterial growth due to being stored at room temperature. Current quality control tests are only 30% sensitive at detecting contamination. Verax PGD testing uses a simple, rapid, and sensitive method to detect both gram positive and negative organisms. It allows platelet outdates to be extended to 7 days if results are negative, improving inventory management and availability. WellSpan Health implemented Verax PGD testing and now transfuses over 30% of platelets past 5 days, reducing wastage from 25% to 12% and saving over $300,000 to date.

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, PhD.
WellSpan Health York Hospital, Transfusion Services, Blood Bank
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Problem Statement
Bacterial contamination poses a great risk in transfusion
medicine, especially for Platelet products.
❖ Data indicates current QC tests are < 30% sensitive
❖ Platelets are stored at room temperature
❖ 1:2,000 platelets potentially bacterially contaminated
❖ Many contaminates are missed due to passive surveillance
❖ FDA has issued draft guidance that additional safety
measures be initiated
Current Condition
Platelet Contamination Risk
❖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
Problem Analysis
❖Platelets are at high risk for contamination and bacterial
growth due to their being a room temperature product
❖Bacterial testing at the time of collection is limited to a small
sample, and may miss an organism that grows in the bag
❖Platelets outdate at only 5 days due to the increasing risk
over time for contamination
❖Platelet inventory is limited, yet platelets are a high demand
product for cancer services, trauma, OR, NICU, and medicine
❖The INTERCEPT pathogen inactivation being marketed by
major blood suppliers has downsides that are unacceptable
for WellSpan patients, including: chemical additives, higher
rates of adverse transfusion reactions, and poor quality
platelets with a short in vivo half life
Goal Statement
❖Reduce the risks for septic transfusion reaction due to platelet
bacterial contamination, especially for 5+ day old platelets.
❖Preserve valuable inventory by avoiding wastage, and
extending outdates to 7 days for bacterially tested products.
❖Implement a testing methodology that is safe for patients,
reliable, accurate, and cost effective.
Target Condition
Verax Pan-Genera Detection Technology was evaluated and
chosen as the best fit to improve safety for WellSpan patients.
Platelets are bacterially tested using a simple screening kit:
❖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
❖Targets the known issue: bacterial contamination
❖Can be used on many types of platelet products, including
triple apheresis products
❖Cost reduction through reduced wastage
❖Improves product availability and safety
Countermeasures
Verax PGD Testing was validated in the blood bank. Test kits
were acquired and protocols developed for daily screening of
platelets past the typical 5 day outdate. Blood bank
technologists were trained to utilize the test kits, and to manage
a larger inventory of platelets. Prior to dispensing a platelet 5
days or older, Verax PGD testing is conducted to rule out
bacterial contamination. Platelet outdates are extended to day
7, if Verax testing remains negative. Ongoing quality assurance
ensures the accuracy and reliability of the Verax PGD kits.
Implementation Plan
Verax PGD Testing Implementation
❖Testing is done within 24 hours of transfusion after 4 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
Follow-up
Verax PGD testing now benefits WellSpan patients:
❖Improved platelet transfusion safety at days 5, 6, and 7
❖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
❖Continued benefit of:
• Single donor platelets (safer than pooled products)
• Double and triple products (based on historical donation
patterns)
Cost/Benefit
Improved Platelet Supply:
❖>30% of platelets now transfused past 5th day with Verax
❖New average wastage = ~12% wastage rate (was at 25%)
❖Can also test platelets from WSH sister hospitals
Ongoing Cost Savings:
❖Total Savings to date > $300,000; ~$10,000 per month
❖Verax cost ~$25/test, reduced via AllSpire GPO contract
❖Created revenue code/regulatory guidance to capture
Bacterial Testing at time of transfusion of Verax tested
platelets = $56.50/ea.
❖Platelets Verax tested day 5, 6 & 7 – one time charge
attached to product & billed at transfusion time