1. TITLE
Reducing Bio burden in Heart for Valves Recoveries that Lead to Discard
TOPIC
Cardiovascular
Background/Objectives
In late 2012 this tissue recovery agency had seen an increase in the bio-burden discard rate for
recovered Heart for Valves (HV). These discards were attributed to either Class I organisms found on the
initial culture by the processor (incoming bio-burden) or Class II organisms that remained on the tissue
following antiseptic treatment (post-processing bio-burden). At least one of the agencies cardiovascular
(CV) processors had also seen an increase in HV bio-burden with their other recovery partners. This
recovery agency began an extensive look at historical data with a goal of identifying factors that led to
an increased bio-burden rate. Some factors were within recovery agency’s control and some were not.
Using the identified factors that were within the control of the recovery agency, process changes were
tested to reduce the overall, or incoming bio-burden; therefore, reducing the post processing bio-
burden that leads to HV tissue discard. Leading factors for increased bio-burden rates were recovery
order (pericardium first vs heart first), heart apex incision technique (incised apex vs apex removed),
pediatric donors, and recovery staff outliers.
Methods
This study had 2 components, historical baseline data and hypothesis tests. 2.5 years of recovery
outcomes were researched (N=398). Some data points collected were cause of death (COD), last seen
alive time (LSAT) or cardiac time of death (CTOD), Warm Ischemic Time (WIT) defined as the duration of
LSAT or CTOD to when the HV was subjected to cold solution, uncooled time defined as portion of WIT
where the body was not cooled, heart exposure time (incision time to heart flush), heart recovery order
(pericardium first vs heart first), donor age, recovery personnel, and CV processor. A smaller subset of
cases (n=102) included a report from one CV processor. This report indicated transportation solution
color at time of processing and the incision technique used on the apex of the heart. HV cultures were
evaluated for each recovery. Incoming bio-burden was recorded as was post processing bio-burden.
Each case represents 1 heart recovery; any incoming and post-processing bio-burden was recorded. In
order for tissue to be used all cultures must be free of any Class I bio-burden and post-processing
cultures must be free of all bio-burden. Only complete HV discards directly attributed bio-burden were
considered as a recorded discard. Cases with technical errors or positive serologies, where final cultures
were canceled, were not included in the study.

2. Results
The baseline incoming bio-burden rate was 63%; and the discard rate attributed to bio-burden was 15%.
Two best practices were identified from the baseline data. The discard rate was 35% lower when HV’s
were recovered prior to pericardium (Table 1). The discard rate was 56% lower when an X incision was
used on the apex of the heart rather than removing the apex of the heart (Table 2). Following the
baseline recoveries pediatric heart valve trays were purchased to provide smaller instrumentation when
recovering pediatric hearts. Over time there was a significant drop in pediatric discards, down to 10%
from a baseline high of 24% (Table 3). The first of three PDSA cycles was performed utilizing the best
practices. PDSA 1 data did not yield significant results. So, staff benchmarking was performed to identify
specific recovery techs that needed improvement. Gemba walks were performed on the highest and
lowest performing tech. Variances in technique were identified and a single tech was given the
opportunity to self-correct. However, PDSA 2 still did not yield significant results. A repeat Gemba found
the same issues in recovery technique. Intensive retraining was instituted and the retrained tech fell in
line with their peers and improved in PDSA 3 by 56% (Table 4). Overall, the agency improved 27%. While
the project yielded positive results, the sample size did not lend itself to strict statistical analysis.

3. Conclusions
One theory is that the pericardium acts as an additional barrier from the lungs. The removed apex is
shipped with the myocardium and may not have been rinsed as well. Ongoing metrics have continued to
support the best practices that were identified. While all tissue donation is valued and life enhancing,
HV donation carries special significance with many families. This is particularly true with families that are
unable to donate solid organs and/or families of pediatric donors where HV is the only tissue donation
opportunity. Improving aseptic techniques and identifying best practices for HV recovery maximizes the
gift of donation.
The data demonstrates the importance identifying variances in recovery staff techniques and their
implications on the outcome of the recovered tissue. Merely identifying best practice may not enough
to ensure that best practices are adhered to. Continuous monitoring and re-training, when necessary,
should be considered when addressing staff outliers.
Author(s)
Brent D. H. Morin
Donor Services Coordinator
Carolina Donor Services
Jennifer A. Mansbery, CTBS
Tissue Donation Coordinator
Carolina Donor Services
Charles R. Poindexter, CTBS
Manager of Tissue Services
Carolina Donor Services
Kimberly T. Koontz, MPH, CTBS
Director of Tissue Services
Carolina Donor Services