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A Histological Evaluation of the Impact of Removing Papaverine from Vascular Recovery and Processing on Tissue Quality

Primary Presenter: Alyce Linthurst. Jones, PhD - Director, Cardiovascular Product Development

Background/Objectives
Several factors have been reported in the literature that may influence the quality of vascular grafts during blood vessel recovery and processing. This includes the dissection technique, distension pressure, presence of papaverine, and the temperature of the solution used to flush the vessels. The objective of this study was to evaluate the histologic impact of removing the smooth muscle relaxant papaverine from vascular recovery (AATB Standard D5.700) and processing.

Methods
Ten donors with research consent, two of which were organ donors, yielding bilateral saphenous veins and femoral arteries were recovered en bloc where one side was flushed with room temperature solution, transported in isotonic solution on wet ice, and processed with papaverine (SMR group) and the opposite side was recovered, transported, and processed identically excluding the use of papaverine (No SMR group). All vessels were disinfected, packaged, and cryopreserved according to AATB-compliant standard operating procedures. Grafts were perfusion fixed, embedded, sectioned, and stained with H&E, anti-CD31, and Verhoeff-Van Gieson. H&E slides from each vessel were qualitatively graded for endothelium detachment, abnormal endothelium, and intact endothelium with anti-CD31 staining as a supporting stain. Verhoeff-Van Gieson stained slides were qualitatively examined for the presence or absence of vasospasm as determined by the undulations of the internal elastic lamina and spiked appearance of smooth muscle cells. A Mann-Whitney Rank Sum test was used to analyze the data (SigmaPlot v11).

Results
There were no statistically significant differences observed for saphenous veins in the No SMR and SMR treatment groups regarding detached cells (organ donors p=0.436; tissue donors p=0.066; all donors p=0.058), abnormal cells (organ donors p=0.931; tissue donors p=0.081; all donors p=0.135), or intact cells (organ donors p=0.212; tissue donors p=0.169; all donors p=0.063). Similarly, there were no statistically significant differences for femoral arteries between the No SMR and SMR treatment groups for detached cells (organ donors p=0.441; tissue donors p=0.843; all donors p=0.612), abnormal cells (organ donors p=0.422; tissue donors p=0.596; all donors p=0.423), or intact cells (organ donors p=1.000; tissue donors p=0.095; all donors p=0.102). There were statistically significant differences between saphenous veins and femoral arteries regarding detached cells, abnormal cells, and intact cells (No SMR and SMR p<0.001). A qualitative assessment of representative Verhoeff-Van Gieson stained images found no indication of vasospasm in any of the saphenous veins or femoral arteries.





Conclusions
The removal of papaverine during recovery and processing did not impact the quality of the saphenous veins or femoral arteries as assessed by histology. This was true for tissue donor vessels as well as organ donor vessels, which were considered as a worst case for risk of vasospasm due to the short warm ischemic times and potentially greater smooth muscle viability. Arterial endothelium was more impacted by the procurement and recovery process than venous endothelium which was expected due to their different physiological responses to oxygen. We conclude that the removal of papaverine from the recovery and processing of saphenous veins and femoral arteries does not alter the presence or absence of endothelium nor does it lead to increased risk of vasospasm during recovery or processing.



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A Team-Based Approach Methodology For Offering Families The Opportunity of Tissue Donation

Primary Presenter: Joshua Brennan, CTBS - Tissue Clinical Coordinator

Primary Objective/Issue studied
This tissue recovery agency has a 15 member team of Tissue Clinical Coordinators (TCC) whose key responsibility is to offer the opportunity of tissue donation to the families of clinically eligible deceased patients in a timely manner. The objective was to create a method to consistently approach all potential donor families in a timely manner. We also wanted to take case ownership away from one individual and distribute the responsibility across the entire team, ensuring this recovery agency would have the ability to reach as many families as possible to offer them the gift of donation.  On average, this recovery agency approaches approximately 340 families per month. Typically, there are 4-5 Tissue Clinical Coordinators (TCC's) on duty between 0700 and 1900 and 2-3 TCC's on duty between 1900 and 0700.

Project
After approximately 4 months (from 10/10-2/11) of below average performance in the key performance metrics of approach, authorization and conversion rates, the management team decided to implement a PDSA where all TCC’s would approach families every 60 to 90 minutes based on the level of clinical activity. Previous to this, one TCC would manage all aspects of each case from the initial hospital screening, communication with all outside entities (medical examiner, hospital, etc) as well as approaching families for authorization for donation. After authorization was obtained the TCC would also be responsible for offering the gifted tissue to respective tissue processors as well as all oversight of the case logistics. This culture created an inequity in case load due to the individual TCC’s maintaining all of the cases that they screened. Moreover, if a TCC was working a complex case this could potentially take their focus off their remaining case load. This in turn created inconsistency in the way that cases were managed as well as the frequency of calls made to a family to offer the opportunity of donation. The final driving force of this new approach method was to reduce the death to preservation time for corneal donors.

data for abstract final 8.1.12.pdf


Results Summary/Outcome/Implementation Strategy:
In March of 2011 after initial concerns were realized and addressed and objectives were identified, representatives from the TCC team attended a strategic planning meeting with Tissue Operations Management as well as members of the Quality Systems Department to map out a plan for changing the family approach process from an individual to team perspective. Implementation began with a visual approach. In the Tissue Operations Center, potential donor cases are displayed via a large, white dry-erase board assigned to individual TCC’s and marked with their initials. The initials fostered sole “ownership” and discouraged team-focused thinking. The TCC initials were eliminated from the dry-erase board. This action visually transformed the potential cases from many individual obligations to multiple team-focused obligations. Information critical to the approach of the potential donor family replaced the TCC initials (i.e. the time(s) the family needs to be called, medical examiner information, refrigeration or cooling issues, etc.) The entire TCC team was now responsible for all potential tissue donors, collectively. In December of 2011 nine months after implementing the new team approach method, the Tissue Operations team further identified ways to enhance the process. We defined and instituted a new version of the team approach method called the Accountability-Communication-Teamwork (ACT) Approach Method. This new re-defined concept emphasized total team accountability and ownership with regards to our overall goals, objectives, and meeting the organizational mission. The Team-Approach methodology was re-affirmed as the highest priority, core concept in the Tissue Operations Center. The ACT method continues to be employed at the present time. Over 13 months of data collection all key metrics have markedly increased. The approach rate had a sharp increase in month 2 to 67% and has remained consistently higher than prior to the PDSA through the next 11 months. We also displayed similar outcomes in authorization rate having a high of 47% in two months as well as in conversion rate with an initial average increase to 26.5% and an upward trend from July 2011 through March 2012. All data is evidenced on the attached table.

Lessons Learned/Author(s) Recommendation
The team based approach methodology has met or exceeded our organizational goals of approach, authorization and conversion rates. Additionally, using this methodology we have been able to reduce the death to preservation time on recovered corneas by a little greater than one hour through a reduction in our referral to authorization time. There have been sustained gains through the last 13 months due to the consistency of this best practice that was implemented in March of 2011.



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Antibiotic Solution for Decontamination of Skin Allografts - Studies of Antimicrobial Effectiveness and Cytotoxicity on Skin Fibroblasts

Primary Presenter: Jialin Yick, BSc (merit) - Medical Technologist

Background/Objectives

In skin banking, the decontamination of donor skin allografts is critical in ensuring graft quality and safety. Currently, the Singapore General Hospital Skin Bank Unit incubates donor allografts in an antibiotics cocktail of vancomycin and amikacin (50µg/ml, 100µg/ml) in Dulbecco's Modified Eagle Medium (DMEM) at 4°C for up to 96 hours.

There were reported concerns on the stability of amikacin in terms of reduced potency1 at higher temperature and for prolonged usage in the decontamination of allografts. Antimicrobial effectiveness of the current cocktail was therefore studied at 4°C and 25°C to determine the effect of temperature on the reduction of bacterial burden. Polymyxin B is widely used against major multidrug-resistant gram negative bacteria and is a lipopeptide antibiotic more stable than amikacin. An alternative cocktail of vancomycin, polymyxin B and gentamicin (100µg/ml, 1000u/ml, 80µg/ml) in DMEM was thus compared to the current antibiotics regime in terms of antimicrobial effectiveness and cytotoxicity on human skin fibroblasts.


Methods

Antibiotics were prepared in DMEM (Lonza). Cocktails tested were (µg/ml):
A: vancomycin (50), amikacin (100);
B: vancomycin (100), polymyxin B (1000u/ml), gentamicin (80)

Bactericidal activity of ≥ 2 log Colony Forming Units (CFU)/ml was used to measure antimicrobial effectiveness. Cocktail A was incubated in bacterial inocula at 25°C and 4°C, and cocktail B at 4°C, with baseline inocula of 6 log CFU/ml. Quantitative cultures at 6, 24, 48, 72 and 96 hours were measured via time kill assay. Bacteria used: Pseudomonas aeruginosa (ATCC 9027 & 27853), Staphylococcus aureus (ATCC 6538 & 29213).

Viability of human skin fibroblasts after incubating with cocktails A and B in growth media (DMEM + 10% Fetal Bovine Calf Serum (FCS)) were compared at day 1 and 6 using MTS based time kill assay.  Conventional cocktail for skin fibroblast culture; penicillin-streptomycin (100u/ml, 100µg/ml) in growth media was used as positive control. Low serum media (DMEM + 2%FCS) was used as negative control. 2 strains of skin fibroblasts were used and seeded onto 24-well plates at a cell seeding density of 5000 cells/well. Fresh treatment media was changed daily. Each treatment arm was in quintuplicates. Statistical analysis was done using one-way ANOVA for multiple group comparisons, Tukey-Kramer for post-test. A p value <0.05 was considered statistically significant.


Results

Cocktail A at 4°C was the most effective against the various bacteria tested. Cocktail B was effective against S. aureus only after 48 hours. (Table 1)

No difference in cell viability between groups was observed at day 1. (Fig. 1) 

At day 6, Tukey post-hoc analysis showed significant difference in the cell viability between the negative control (low serum) and the 3 growth media treatment groups, attesting to the effectiveness of this control in the setup. Finally, no cytotoxic effect was observed in the groups treated with cocktails A and B as their cell viabilities were comparable to that in the positive control. (Fig.1)


Conclusions

The combination of vancomycin (50µg/ml) and amikacin (100µg/ml) in DMEM is an effective cocktail in eliminating P. aeruginosa and S. aureus at an incubation temperature of 4°C up to 96 hours. However, the cocktail was no longer effective against P. aeruginosa at 25°C. Therefore, maintaining an appropriate incubation temperature for the above cocktail is critical for its antimicrobial effectiveness.

  1. Heng WL, et al. (2012) From Penicillin-Streptomycin to Amikacin-Vancomycin: Antibiotic Decontamination of Cardiovascular Homografts in Singapore. PLoS ONE 7: e51605



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Autograft (Split-Thickness Skin) Tissue Storage and Best Practices

Primary Presenter: Gabriella Hernandez

Primary Objective/Issue studied
A burn patient's own skin (autograft) is irreplaceable. Autograft tissue can be used as a permanent skin transplant for the burn patient. The methods and procedures used to store and maintain the autograft can have a critical impact of the outcome of the autograft transplant. Inadequate handling and storage of tissue can result in tissue contamination, loss of graft, and/ or decreased viability of the tissue. Although some of the organizations that govern hospital's practices have a standard of care for some aspects of tissue safety, currently these same organizations have no established guidelines for the following procedures: Disinfection of tissue, storage medium, time interval for changing of storage medium, addition of antibiotics to the storage medium, culturing of tissue, and physician notification of tissue with positive cultures. The purpose of this study was to assess current burn unit practices for storage and handling of autograft tissue.

Project
A literature review was performed on current practices of hospital burn units on the storage of autograft (skin) tissue. Key points in the review include; the type of medium used to store tissues, storage time, changing of storage medium, and microbial surveillance.

Results Summary/Outcome/Implementation Strategy:

The results of a literature search for autograft (skin) tissue storage practices were scarce. Only 7 literature articles were found and this included burn units within United States as well as international burn units. The articles describe many different practices that exist among the burn units for the storage of autograft skin. While all the burn units stated that they store the tissue at 4 degrees Celsius, most of their other storage practices were not shared. A few burn units stored their autograft tissue in cell culture media (e.g. RPMI, DMEM) while others stored the tissue in normal saline. One burn unit even stored their tissue in saline-moistened gauze. For culturing of the stored tissue, only one burn unit reported that their tissue is cultured for bacteria and fungi. The length of storage varied from as short as 7 days to greater than 21 days. Changing of the storage solution also varied. Only one of the burn units reported that they change the storage solution while the others reported that the storage solution isn’t changed.

There wasn’t a clear rationale for most of these practices. One burn unit did perform a study to scientifically review the evidence behind their storage practices. After the review some of their storage practices were changed. For example, they changed their practice of storing tissue in normal saline to cell culture medium (DMEM) and they also made the decision to reduce the storage time from 14 days to 7 days. The reduction in storage time was a result of a viability test that was performed on stored tissue and the results showed the tissue wasn’t viable after 7 days when refrigerated at 4 degrees Celsius in DMEM. While this rationale may sound reasonable, the factor of changing the storage solution every 72 hours (current AATB Standard) was not addressed. This factor alone may allow the tissue to stay viable for the original 14 day period.



Lessons Learned/Author(s) Recommendation
After reviewing the literature for storage of autograft tissue, it is evident that these practices/procedures can vary from burn unit to burn unit. The safety of the tissue as well as the patient could be affected due to a lack of uniform protocols. This study identifies opportunities to lessen regional variations in the storage and handling of autograft tissue, by encouraging uniform application of protocols utilizing evidence based guidelines. It would be beneficial to burn units and patients to have guidelines that address the following: Disinfection of tissue, storage medium, time interval for changing of storage medium, addition of antibiotics to the storage medium, culturing of tissue, and physician notification of tissue with positive cultures.



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Building a Culture of Problem Solving Through Continuous Improvement

Primary Presenter: Kathy Simpson, RN, CTBS - Manager of Wisconsin Tissue Bank

Primary Objective/Issue studied
In 2011, our Organ Procurement Organization (OPO) and Tissue Bank (a service line of a BloodCenter), committed to implementing Lean methodologies and Continuous Improvement to enhance the quality of service provided to our donor hospitals and families while eliminating waste and creating standard work. The BloodCenter's Continuous Improvement Department completed training for organ and tissue staff on the methodologies that the BloodCenter had embraced. All staff were provided a copy of “On the Mend” to begin their understanding of how healthcare can successfully implement continuous improvement.

Project
The BloodCenter's Continuous Improvement Office provided training on Value Stream Mapping to staff prior to any event. As a result of the initial Value Stream Mapping event, the team members continued to conduct a number of smaller events with other departments within the OPO/TB. The subsequent events were mainly facilitated by staff, not managers. This allowed for further staff professional and leadership development. The Recovery Services Coordinators, Hospital Development Coordinators, Volunteer Coordinators, Tissue Screeners, and Tissue Recovery Coordinators all have conducted Value Stream Mapping. The OPO and Tissue Bank also initiated a pilot of the ThedaCare Business Performance System on March 1st 2012 with the goal to build a culture of problem solving. A daily morning huddle is held by staff for 15 minutes to review the work in progress, to determine what barriers affecting the completion of the idea, to discuss and prioritize any new ideas or identified problems, and to celebrate any successes that the team has experienced. This daily exchange encourages the team to see defects and waste in the process and for leadership to encourage and join staff in problem solving. The huddle board is a visual management tool that encourages transparency amongst the different departments within the Organ and Tissue teams. All leaders are also devoting time to be in Gemba to visualize the process and barriers that teams experience firsthand. The manager’s time in Gemba is posted on a calendar within the office so it is visible to all staff.

Results Summary/Outcome/Implementation Strategy:
Through the Value Stream Mapping Events and the first month of the Daily Huddle staff identified over 60 Just Do Its, Projects, and Kaizens, and have implemented 26. The second month staff successfully implemented 25 continuous improvement ideas. Staff are actively participating and facilitating the huddle, which is also contributing to their professional and leadership development.



Lessons Learned/Author(s) Recommendation
The daily huddle requires commitment and encouragement by leadership for success. Staff need to feel empowered to problem solve and identify solutions and process improvements. The use of the Value Stream Mapping and Daily Huddle Board has begun to gain the support and engagement of staff for identifying improvements to their daily responsibilities. This staff driven process is building our new culture of problem solving. The Critical Lesson Learned: Empower staff to manage this process.



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Cardiovascular Pathology Service at a Tissue Processor

Primary Presenter: Thadeus J. Schulz, MD - Pathologist

Background
The processor is a biotechnology company that does tissue processing of cryopreserved human aortic and pulmonary valves as well as blood vessels for cardiac and vascular reconstructive surgery. As part of the donor evaluation screening process the processor provides on site histopathology laboratory and on site cardiovascular pathology evaluation of donor hearts. Human donor hearts and vascular tissues are recovered in 43 states and Puerto Rico and shipped to the processor's central location. For more than seven years the tissue processor has been offering in house pathology laboratory services.

Primary Objective
Limited examination of coronary arteries and heart can be performed by medical examiners/coroners prior to shipment to the processor. The heart apex may be retained by the medical examiner/coroner. The processor cases involve involve ME/coroners autopsy cases and additional cases that are not autopsy cases. On site internal consultation at the processor is afforded by having specialized cardiovascular pathologists present where the high volume of cases generates reports on many rarely seen cardiovascular pathologic entities as well as routine cases. The processor and other tissue processors rely on these reports to evaluate for such entities as: 1) Coronary artery disease, 2) Myocardial infarction, 3) Myocarditis, 4) Sepsis, 5) Benign tumors, 6) Malignancies, 7) Congenital defects, 8) Valvular abnormalities, 9) Conduction system defects, 10) Amyloidosis, and 11) Postmortem bacterial or fungal growth.

Optional Text Area
NA

Summary / Outcome / Implementation Strategy
Timely coordinated evaluation of donor charts and heart pathology by a staff of four pathologists results in approximately 2000 written heart pathology reports a year. These reports are sent to recovery partners (RPs), tissue banks, other tissue processors, organ procurement organizations(OPOs), and medical examiners(ME)/coroners at no charge. Medical examiners/coroners can have glass slides and wet fixed tissues returned to them for evaluation. Wet tissues are retained for 90 days and paraffin embedded tissue blocks and glass slides are retained at the processor for at least ten years.

Conclusion / Author(s) Recommendation
The pathology service needs of tissue donors and recipients, tissue banks, tissue processors, organ procurement organizations(OPOs), and medical examiners/coroners are being met by having a centralized cardiovascular pathology service at a tissue processor.



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Clinical Results from a Multicenter Registry Study on the Use of Processed Nerve Allograft for Sensory, Mixed, and Motor Nerve Repairs

Primary Presenter: Florence Beck, CTBS - Clinical Research Manager

Background/Objectives
Each year over 700,000 patients present to the emergency department with a new peripheral nerve injury. These injuries are a major source of disability by impairing motor and sensory functions. The repair of transected peripheral nerves poses a significant surgical challenge when a gap exists between the proximal and distal segments. Continuity on the nerve must be restored in order to permit return of function. The historical treatment for nerve injuries resulting in a gap is a nerve autograft. Unfortunately the recovery of autograft tissue presents challenges to the surgeon and the patient including: additional surgery and risks associated with it, donor site morbidity and limited tissue availability, as well as increased operative time and cost associated with tissue recovery. Due to these challenges, alternatives to the nerve autograft have been actively sought. In 2007, advances in tissue processing techniques resulted in the first off-the-shelf processed nerve allograft. Nerve tissue, from human cadaveric donors, is recovered utilizing standard recovery techniques at FDA registered recovery centers and then intricately processed to yield a decellularized, pre-degenerated and sterilized extracellular matrix (ECM). As a result, the tissue’s dimensional structure is preserved and immunosuppressive therapy is not required, a constraint limiting the clinical use of previous nerve allografts. In 2008, a multi-center registry was initiated on the use of processed nerve allografts to provide additional clinical data on the expected results as part of standard of care. Here we report our findings from an ongoing registry (RANGER) on the utilization and outcomes of processed nerve allograft.

Methods
The RANGER registry, established in 16 centers with 32 surgeons, is designed to continuously monitor and incorporate injury, repair, safety and outcomes data for processed nerve allografts. Each participating site followed their own standard of care. Collected data, using standardized case report forms, included assessments for safety, sensory function, and motor function. Analysis was performed using descriptive statistics. Successful recovery, based from the literature, was defined by the Medical Research Council’s scale at S3 or greater for sensory function and M3 or greater for motor function. The current database resulted in 141 subjects with 190 nerve repairs. Subjects who provided sufficient follow-up (recovery time) to evaluate clinical outcomes were included in the analysis. Descriptive statistical methods were used to summarize the data. Subgroup analysis was completed by nerve function. Results from this study were also compared to historical controls from the literature.

Results
Sufficient recovery time elapsed to assess the results for 66 subjects and 92 injuries in the database. There were 65 sensory, 9 motor, 18 mixed nerve repairs. The mean ±SD (minimum,maximum) age was 40±16 (18-70). The mean gap was 23±12 (5-50) mm. Successful recovery was reported in 89% of the all repairs. Further subgroup analysis by nerve function demonstrated successful recovery in 87 % of the cases for sensory function and in 84% of the cases for motor function. There were no reported graft related complications, tissue rejections, or adverse events. Comparisons to historical controls in were favorable to nerve autograft as shown in Table 1.



Conclusions
Our results found processed nerve allografts can be used to reconstruct sensory, mixed, and motor nerve injuries between 5 and 50 mm. These results compare favorably to historical data for nerve repair. This registry study is currently in open enrollment; additional data collection will include added follow-up from existing subjects as well as increased enrollment from current and new sites to provide further utilization and outcomes data.



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Collaboration with a national professional organization to develop continuing education for funeral professionals.

Primary Presenter: James Mohr, RT, MBA, CTBS - Senior Program Advisor

Primary Objective/Issue studied

A survey of Canadian eye and tissue banks indicates many do not formally or routinely engage funeral professionals as active members in the end of life care donation team.  Funeral professionals indicate that 50% of all funerals are pre-planned presenting a logical opportunity to initiate a discussion with clients about donation. The provision of funeral services is impacted by the surgical recovery of organs and tissues.  Canadian Blood Services and the Funeral Services Association of Canada collaborated in the development of an on-line donation course, targeted to funeral professionals, to advance donation opportunities and improve relationships with recovery organizations.

Project
Experts in on-line learning solutions were retained to manage the development and execution of the course. A panel of 5 experts were convened to inform course content. Expert backgrounds included a Funeral Home/Medical Examiner Liaison, an Eye Bank, a Tissue Bank, a Provincial Donation Organization and an expert in organ donation. The project was managed by a Canadian Blood Services donation and transplantation expert in collaboration with the Executive Director of the Funeral Services Association of Canada. Development phases occurred over 6 months and included instructional design, content discovery, wireframe creative, story board creative, course interface, beta creation and final development. The course was officially launched at the 2013 Annual General Meeting of the Funeral Services Association of Canada, has been approved for Continuing Education Units, is provided in both English and French and is hosted by the Funeral Services Association of Canada website (www.fsac.ca).

Results Summary/Outcome/Implementation Strategy:

The course has two components. Module 1 provides funeral professionals with knowledge and motivation to appropriately and positively raise the opportunity for donation during funeral pre-planning conversations and to direct clients to donation resources and donation intent registries to action their wishes or obtain additional information. Module 1 shares donor family and recipient testimonials, provides insight into donation criteria and the donation process, introduces the concept of dual advocacy and provides examples of how to initiate effective donation conversations. Linkages to provincial donation organizations and intent registries are provided to facilitate communication.

Module 2 provides funeral professionals with knowledge of the impact of organ and tissue recovery on the provision of funeral services and supports the development of collaborative working relationships between funeral professionals and recovery organizations. This section describes surgical recovery, factors affecting recovery timing, the release of the body, provides guidance on expected practice in body reconstruction and preparation for return to the funeral home and provides strategies to support the development of collaborative working relationships with recovery organizations. Linkages to provincial donation and recovery organizations are provided to facilitate communication.


Lessons Learned/Author(s) Recommendation

Funeral professionals are key members of the end of life care team. They have the opportunity to initiate donation discussions with a significant component of the population and are directly impacted by the surgical recovery or organs and tissues. Providing easily accessible professional education will advance donation, increase donation discussions and foster more collaborative working relationships between donation and recovery organizations and funeral professionals.

Each course participant is asked to complete a course evaluation. The evaluation will compare their level of confidence in discussing organ and tissue donation with clients before taking the course with their confidence level following course completion.  The evaluation also assesses the participant’s perception of donation discussions as a professional responsibility and their assessment of course content.  Learning’s from participant evaluations will be used to inform and optimize course content.




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Comparative Reliability of Serological vs. Nucleic Acid Testing in Donor Screening

Primary Presenter: Ron Wendolowski - Manager, Donor Records

Primary Objective/Issue studied
Donor screening is a critical and complex process of gathering and analyzing all available medical and social information within a time sensitive window in order to authorize the recovery of a referred case, while struggling to honor the wishes of the donor or donor family as well as balancing any potential safety risks to future tissue recipients. Hospital records, past medical history and family interviews play a key role in this process and are valuable tools used during initial donor screening evaluation. Although typically available on organ recovery cases at this early stage, results of serology panels also provide significant information and can be a vital piece of the assessment process. Challenges arise in obtaining the results of the complete panel including NATs, which are likely still pending and not available within the required time limits when a decision must be made to accept or defer the case. The primary objective of this study was to evaluate the risk in reliance on available serology results during the donor screening and acceptance process when NAT results are still pending. If cases are accepted based on known negative serology results, what is the risk of case rejection due to an ultimate repeatedly reactive NAT result?

Project
Sample selection included data gathered on laboratory test results from a single laboratory on >10,000 donors from May 2011 through May 2012. No demographic or specific donor information was obtained or reviewed other than the serology test results. Serological methods were based on routine testing panels for organ/tissue donors including HIV1/2, HBsAg, HCV, HBc Total, Syphilis and HTLV I/II, with the results measured as Repeatedly Reactive (+) or Non-Reactive (-). False positive results or confirmatory data were not a focus of this current evaluation but raise a question for additional analysis in the future.

Results Summary/Outcome/Implementation Strategy:
The final results of ten thousand and eighty-nine (10,089) serology panels tested were evaluated and broken down into four categories, including number of panels tested and corresponding rates [Table 1].



Lessons Learned/Author(s) Recommendation
Non-reactive serology results, when available at the time of initial donor screening, are strong indicators of ultimate non-reactive NAT results and can be considered a valuable tool in the donor screening and acceptance process. This data concludes the risk of an ultimate rejection due to reactive NAT, when the serology panel is non-reactive, is likely to be approximately only 0.2%. Conversely, > 99% of cases with negative or non-reactive serology results would likely have negative or non-reactive nucleic (NAT) test results. Conclusion: the risk is very low.



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Contribution of NAT for HBV DNA to a better diagnostic of HBV Infections among organ and tissue donors

Primary Presenter: Claudia Chinchilla-Reyes, MB(ASCP)CM - Quality Assurance and Research Development Manager

Background/Objectives

HBV co-exists in distinct forms of particles: complete virions/particles with DNA genome surrounded by the HBcAg/HBsAg and “empty” virions lacking HBV DNA.  These small 22nm spherical or tubular forms without HBV DNA (“empty Dane’s particles”) are synthesized in excess (>2,000 fold) of the 42 nm complete virions. The mechanism regulating synthesis of “empty” vs. complete HBV is poorly understood. Currently HBsAg + HBcAb screening is used to reduce organ and tissue-transmitted HBV infection.  Although this serologic testing algorithm reduces transplant-transmitted HBV infections, some HBsAg-negative donors can still transmit HBV to transplant recipients (“window donors”). Also, resolving so-called “anti-HBc+ only” donors continue to be a problem and donors are being excluded rather than subjected to further testing. Finally “occult” HBV   infection (absence of HBsAg, and low viral replication) continues to be a problem leading to unknown number of transmission. Therefore, to further reduce the risk of transplant-related HBV, in December of 2011, our laboratory began screening all organ and tissue donors using TMA-based multiplexing NAT assay capable of detecting HBV DNA in addition to HCV and HIV RNA.

Aim
To share our data obtained during NAT+serology screening for HBV of organ and tissue donors in the Western USA obtained during 18 months of real-time testing.


Methods

Between December 2011 and May 2013, we tested 8,355 organ and tissue donors.  We used Genetic Systems HBsAg EIA 3.0 (Bio-Rad Laboratories) to test for HBsAg;  Ortho HBc ELISA Test System (Ortho-Clinical Diagnostics, Inc.) for HBcAb and Procleix ULTRIO Multiplex TMA (Gen-Probe Inc.)  for HBV DNA.


Results

588 (7.03%) donors had evidence of prior HBV exposure. All 38 HBV DNA reactive donors also had reactivity for at least one of the serology markers (Table 1 &3).  5 HBsAg reactive donors were also anti-HBc reactive (Table 2). 12 donors had the Occult HBV Infection marker pattern; HBsAg nonreactive, HBV DNA reactive and anti-HBc reactive (p<0.05). (Table 3).

 

Table 1. Summary of HBV NAT & Serology Results by Marker

Total Tested

HBsAg(+)

Anti-HBc (+)

HBV DNA

8,355

57 (0.68%)

562 (6.72%)

38 (0.45%)

 

Table 2. Anti-HBc & HBsAg status for HBV DNA Non-Reactive Donors

 

HBsAg (-)

HBsAg (+)

Anti-HBc (-)

7767

26

Anti HBc (+)

519

5

 

Table 3. Anti-HBc & HBsAg status for HBV DNA Reactive Donors

 

HBsAg (-)

HBsAg (+)

Anti-HBc (-)

0

0

Anti HBc (+)

12

26



Conclusions

57 (0.68%) organ and tissue donors had markers of ongoing HBV Infection (HBsAg and HBV DNA). No “HBV DNA reactive only” nor “NAT yield” donors were identified. 2.04% of  donors with evidence of prior HBV exposure had occult HBV Infection (12/588) . 6.2% of donors were reactive for “anti-HBc only”(519/8355). At least some organ and tissue from these donors may be considered for transplantation (no viremia) or for further testing (HBsAg).  Considering the fact that HBV as DNA virus can survive ex-vivo for extended period of time, screening organ and tissue donors for HBV DNA may benefit the transplant community by providing additional information about donor infectivity status.




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CryoValve® SG Human Aortic Valve: The Next Generation Allograft Heart Valve

Primary Presenter: Stacy G. Arnold, MS - Senior R&D Engineer

Background/Objectives

A combination of in vitro bench data, in vivo animal data and human clinical data demonstrate the benefits of SynerGraft technology when applied to allograft aortic heart valves.  SynerGraft technology was developed to decellularize allograft tissue without negatively impacting the structural integrity of the tissue.  The CryoValve SG Human Aortic Valve (CryoValve SGAV) has received a Humanitarian Use Device designation from the US FDA.  Review for a Humanitarian Device Exemption by FDA is pending.




Methods

All studies were performed as comparative assessments between SynerGraft processed, cryopreserved aortic valves and conventionally processed, cryopreserved aortic valves.

Bench Studies:
In vitro long-term durability and hemodynamic performance was evaluated over 80 million cycles under physiological conditions per ISO5840 for viscoelastic materials.

Animal Studies:
An ovine model was used to assess the long-term safety and performance of the CryoValve SGAV.  Histological evaluation was used to assess pannus formation and calcification.

Human Clinical Studies:
Valve performance was evaluated in a total of 50 pediatric CryoValve SGAV recipients.  The retrospective clinical study assessed safety and function of the CryoValve SGAV with a maximum follow-up of seven years. 

Results

In vitro durability and hemodynamic studies demonstrated no impact on the structural integrity and performance of allograft heart valves treated with the SynerGraft decellularization technology.

In vivo animal study results suggest that the CryoValve SGAV is safe for its intended use.  Compared to a non-SynerGraft treated allograft heart valve, histology results suggested a reduction in pannus formation and conduit calcification.  Pathologic and hemodynamic data demonstrated comparable performance to the non-SynerGraft treated allograft heart valve.

The human clinical pediatric study demonstrated 100% freedom from thromboembolism, thrombosis, endocarditis, hemolysis, and nonstructural dysfunction at 5 years.  Freedom from explant was 92.5% compared to 81.9% for the non-SynerGraft treated CryoValve AV at 5 years.  Additionally, CryoValve SGAV maintained 95.6% freedom from mortality and 94.6% freedom from structural valve deterioration at 5 years.  Hemodynamic results are listed in Table 1.

Conclusions

These studies demonstrate that the SynerGraft decellularization technology offers a significant advantage in terms of safety and performance when applied to allograft heart valves.  This processing paradigm may represent the next generation of allograft heart valves.




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Differences between tissue requesters’ (TRs) perceptions of families’ attitudes and family decision-makers’ (FDMs) attitudes toward tissue donation

Primary Presenter: Lindsey Kurland, PhD Social and Behavioral Health

Primary Objective/Issue studied

The public is familiar with the far-reaching impact of organ donation.  Although there are thousands more people affected by tissue donation, it has not yet gained the same degree of familiarity and understanding as organ donation.  Further, little research has been conducted on the public’s attitudes specifically toward tissue donation.  Siminoff, Traino, and Gordon (2010) found that families’ attitudes towards tissue donation were a significant predictor of consent; specifically, families that were initially favorable towards tissue donation were more likely to donate their loved ones tissues than families that were initially unfavorable towards tissue donation.  Understanding the public’s attitudes toward tissue donation is crucial to developing an intervention to change negative attitudes and ultimately increase the consent rate for tissue donation. 

Project
Two perspectives were sought (TRs and FDMs) in order to gain a better understanding of the public’s attitudes toward tissue donation. Using a qualitative coding approach and the Tripartite Model of Attitude Structure (affective, behavioral, and cognitive attitude components) as a conceptual framework, families’ expressed attitudes toward tissue donation were extracted from N=240 audiorecordings of past tissue donation requests from 16 different OPOs. In addition, semi-structured interviews were conducted with N=14 Tissue Requesters from LifeNet Health in Virginia Beach, Virginia about their perceptions of families’ attitudes.

Results Summary/Outcome/Implementation Strategy:
Thirteen attitude domains and 37 subdomains were derived from the tissue requesters’ perceptions of families’ attitudes toward tissue donation.  Fourteen attitude domains and 34 subdomains were derived from the families’ expressed attitudes.  Some of the domains from the two perspectives overlapped (e.g., “donation invokes positive emotion” and “false beliefs regarding eligibility”).  Incongruent domains included “distrust of the medical and tissue donation industries”, which TRs discussed but FDMs did not endorse, and “money”, which FDMs endorsed but TRs did not discuss. 

Lessons Learned/Author(s) Recommendation
It was interesting to note the domains and subdomains that were incongruent between TRs and FDMs, as there are implications for how TRs can address some of the more seemingly important issues to families, concerns about money in particular, and omit others during their future requests with FDMs.  Currently, TRs are not required by any regulating authority to discuss the cost of donation or the possibility of donated tissues being distributed to for-profit companies, and yet, these issues were salient among families’ attitudes toward tissue donation.  This has implications for future policies related to the information that is bestowed and TRs’ responsibilities during tissue donation requests. 



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Donation and the Funeral Industry Symposium Model

Primary Presenter: Abigail L. Brentlinger, BS, CTBS - Toledo Branch Supervisor

Background
The local tissue bank works with a donor population of 1.1 million as well as approximately 130 funeral homes in the service area. Upon review of current practices with funeral homes there was interest in strengthening the working relationship between tissue and organ recovery agencies and funeral homes.

Primary Objective
In evaluating what services would be helpful to funeral homes it was decided to provide an educational service to funeral homes as a tool to their business and success in working with families for both agencies. A seminar was organized to offer continuing education (CE) credits incorporating topics related to the funeral industry and organ, tissue, and eye donation. There was also a need to retrieve some feedback regarding best practices and what works or does not work regarding the donation process and planning for end of life services.

Optional Text Area
With support and recommendations from local funeral homes, the planning started by selecting several topics that may be of interest to funeral directors/embalmers. The funeral directors overwhelmingly requested to have an expert in the field of embalming as a featured speaker. Other topics of interest were selected that included: the Best Practices as outlined by AATB, AOPO, and NFDA; End of Life Legal Issues; and Complicated Grief. A venue was also selected to accommodate the estimated number of attendees which was between 100-150 people. Paperwork was submitted to the state for continuing education credits to be offered. The event was sponsored by recovery partners to share information regarding the donation aspect and by local funeral industry vendors (memorials, embalming products, caskets, etc) to share information directly related to funeral planning. Advertising for the seminar was done by word of mouth, telephone calls, brochures, internet advertising, mailings and hand delivery of brochures.

Summary / Outcome / Implementation Strategy
Due to the nature of the funeral home business there were not many registrants for the seminar until the week prior to the event which also happened to be the registration deadline. With 63 funeral directors turning in evaluations for CE the desired number of attendees was lower than anticipated but still a great turnout for the inaugural event. From verbal feedback the funeral directors were impressed with the number of CE hours offered, the meals, and the caliber of the speakers for the low registration fee of $25. Greater than 87% of the attendees felt that the 13 objectives of the meeting were met with one person stating that it was a "Very informative Continuing Ed Session". There were 7 questions asked on the evaluation that required written answers and the feedback was very constructive in what topics the funeral homes are most concerned about. The answers that were provided will also allow recovery agencies to evaluate their current practices to make improvements or changes to better serve the funeral homes. The vendors were very impressed with the seminar due to having the opportunity to meet with potential customers that they might not have the opportunity to interact with otherwise. The vendors had time to spend with the attendees prior to the seminar, during breaks and during the lunch session. The venue was also helpful in allowing the vendors to set up so that every table was easy to view and access.

Conclusion / Author(s) Recommendation
Although data is not currently available regarding how many attendees actually changed their practice in working with tissue banks to promote donation, 98% of the attendees did agree that the objective of "recognizing the role donation plays in society" was met. With all of the ideas shared from the evaluations following this seminar there is interest in planning this type of event on a smaller scale. A shorter presentation could be put together and approved for CE credits so that it could be presented at various funeral homes or district meetings. This would allow for more funeral directors, embalmers, and staff to attend with less worry about what may be planned with their business. This would also encourage more one on one discussion of topics and may be more engaging as well as strengthen the relationship with the tissue bank's presence. If a meeting was scheduled for the future a bi-annual event would be sufficient to cover updates and changes in the funeral home and tissue bank industry.



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Done Vida Health Fair Feria de La Familia

Primary Presenter: Carlos Castro, BA - Education Specialist II

Research/Situation Analysis

The Hispanic population in the state of Georgia has increased by 96% from 2000 to 2013, based on US Census data and many needs have been exposed, including the increased number of Hispanics waiting for transplants in Georgia. LifeLink of Georgia saw a need to educate Georgia’s Hispanic community about organ and tissue donation, and in 2005 hired an education specialist within the Multicultural Donation Education Program (MDEP). We soon learned that more than 73% of Hispanics in metropolitan Atlanta had less than a high school education and most never heard about organ and tissue donation. Carlos Castro, the education specialist began sharing organ and tissue donation information through a variety of methods including at consulates, soccer leagues, churches, schools, etc. Six years ago, Carlos took the lead to implement the Done Vida Feria de la Familia, (Donate Life Family Health Fair), a day-long event that brings together various health-related organizations to provide information and medical screenings to the Hispanic community in metropolitan Atlanta.


Objectives
The Done Vida Feria de la Familia’s objectives include: offer medical screenings free of charge to attendees, offer health-related information to attendees free of charge, provide organ and tissue donation information and registration opportunities to attendees. Done Vida is an event focused on the Hispanic Community of Atlanta. The idea was to create a health-related event that reached uninsured and under insured Hispanics and, at the same time, educate Hispanics about the importance of organ and tissue donation to close the gap between Hispanic donors vs. Hispanics on the waiting list.


Implementation
The first Done Vida Feria de la Familia took place in 2008 and has become an annual event. Health-related organizations were secured to participate as were medical practitioners who conducted the screenings including blood pressure, cholesterol, hearing, vision, HIV/AIDS and back to school physicals. A centrally-located venue was selected each year with ample parking and activities for children. Promotional flyers and posters were distributed to apartment complexes, stores and through Hispanic-oriented organizations. In addition newspaper ads promoted the event. In 2011 Hispanic media attended the event and Univision chose to partner with LifeLink in 2012 and 2013. This partnership helped reach a significantly larger audience through the use of television ads. In Georgia, Univision reaches 500,000 Hispanics daily. In addition, there were a series of interviews on television and affiliated radio stations that provided the opportunity to discuss the need for organ and tissue donors, share testimonials of transplant recipients and donor families, and encourage the audience to make a decision about becoming an organ and tissue donor.

Evaluation

The first three Feria’s de la Familia had between 400 - 600 attendees with 19 exhibitors and five medical providers. There were 25 - 30 new designated donors at each event. In 2012 over 1,200 people attended with 32 medical exhibitors and 101 new registered donors. In 2013 the attendance surpassed 2,000 people and there were 416 medical tests performed to include vision, blood pressure, cholesterol, diabetes, pregnancy, HIV, dental, etc. LifeLink directly reached more than 400 people and had 76 new donor registrations through completion of the paper registry forms and another 28 registered via the DoneVida.org website. We attribute some of the 2013 increased attendance to the six TV interviews and numerous radio interviews leading up to the event.


Budget

The budget for this event is minimal. In 2013 LifeLink spent $1,680 for the venue and welcome banner shown above. Univision donated more than $5,000 in promotional advertising. Papa Johns donated pizza for the vendors at the event and Clinica Internacional de la Mama donated water for the exhibitors. In addition, each health organization gave away information and/or trinkets. LifeLink utilized standard trinkets including hand sanitizers, green bracelets and pens which were already in stock and not ordered specifically for this event.


Creativity/Innovation
The Multicultural Donation Education Program took the lead in filling in a healthcare gap for Hispanic communities in metropolitan Atlanta. Because of the results, the excellent reputation of LifeLink and its partner Univision, the Done Vida Feria de la Familia has become one of the most important health fair events in Atlanta. Health organizations, agencies, hospitals and medical centers look forward to participating each year. Planning for the 2014 Feria event will begin within the next few months



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Donor Registry Tissue Recovery Prior to Family Contact: Pilot Project

Primary Presenter: Bruce Nicely, RN, MSN, CPTC - Clinical Director, Tissue

Primary Objective/Issue studied

Many states have reinforced the validity of their Uniform Anatomical Gift Acts regarding an individual’s donor designation.1   Organ Procurement Organizations (OPOs) have acted upon registry decisions for organ recovery; however, the experience with tissue recovery is unclear. We sought to test tissue recovery based upon authorization from a legal donor registry, using minimal screening criteria and prior to any contact with the legal next of kin. We planned to recover tissue from ten registered first person authorized (FPA) donors.

1Michigan Compiled Laws 333.10114 (3); Uniform Anatomical Gift Law.

Project
The OPO collaborated with Musculoskeletal Transplant Foundation (MTF), an ATB accredited tissue bank, to develop criteria. Donors pursued in the traditional manner of recovery after discussion with legal next of kin, and obtaining a Donor Risk Assessment Interview (DRAI) comprise the control group, while the pilot project cases were the experimental group to establish whether or not it is feasible to act upon donor registries prior to family contact in cases of tissue recovery. The OPO and MTF agreed upon the criteria under which that risk would be shared. Potential donors were under the age of 55 years; were cleared or released by the medical examiner (if applicable); died (or were pronounced) in the Emergency Department; had an accessible hospital record; and met all other criteria established by the tissue bank. If the potential donor met those criteria, and if the decedent was found and verified on a state’s donor registry, tissue recovery was completed. The OPO agreed to attempt to reach next of kin and complete a DRAI within 70 hours of the last known alive time, or time of death, whichever was earlier. Because of some ambiguity in the law, and to avoid problems if families were unable to select a funeral home in a timely manner, the OPO chose to perform tissue recoveries at the donor hospital. All standard recovery protocols were followed, and standard infectious disease testing was performed.

Results Summary/Outcome/Implementation Strategy:

For the ten cases, DRAIs were completed on all; one was ruled out prior to recovery because the family disclosed that the decedent had an autoimmune process; and one was ruled out by MTF’s medical director because of probable ankylosing spondlylitis. Eight remaining FPA donors were recovered, and all eight had negative infectious disease panels. All had acceptable medical records; all donors’ families provided DRAIs within the time limit; and all eight had tissue processing culture results that were acceptable. All eight were released by the tissue bank’s medical director for processing and distribution. There was no financial impact to the OPO, and the cases provided suitable tissue for distribution for the tissue bank. A seven question, five-point, Leikert scale family satisfaction score for the study group was equivalent to the control group families interviewed




Lessons Learned/Author(s) Recommendation

Pursuit of FPA tissue donors in the context of clearly defined guidelines would be viable. Eighty-nine percent (8/9) of donors met suitability criteria throughout the process, and donors' families expressed no reservations about the process or timing. Recovery of donor tissue authorized by recognized documentation of gift, such as a donor registry, seems feasible when reasonable screening criteria are applied.




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Efficacy of different sterilizing solutions on the contaminated bone: an experimental study in human bone allograft.

Primary Presenter: Priscila Cardoso. Cristovam, Priscila Cristovam

Background/Objectives

The use of bone grafts in orthopedic surgical procedures has become increasingly frequent. However, obtaining it still presents many obstacles. The lack of information to the population about the possibility of donating bone tissue and also of teams able to capture and prepare the donor bone tissue, combined with strict exclusion criteria for donors restrict the amount of available tissue for transplantation. Once the catchment is performed within the procedures recommended by Brazilian Health Surveillance Agency, it is estimated that the bone tissue is not contaminated. However, tissue processing in ideal conditions of asepsis and antisepsis does not guarantee sterility. According to the American Association of Tissue Banks (AATB) standards, bone tissues are discarded when contamination is quantitatively significant. When a small amount of recovered segments are contaminated, the choices are discarding or submit them to secondary sterilization. Various attempts are made to decontaminate tissues for transplantation. The hypothesis of this work is that some antiseptic solutions are able to decontaminate tissues. The aim of this study was to determine the efficacy of different antiseptic solutions in disinfecting contaminated bone allograft.


Methods

Under sterile conditions, a discarded human femur for transplantation was cut into 120 fragments. The bone samples were uniformly contaminated with a 1,5 x 108 CFU/ml bacterial suspension (Staphylococcus aureus, American Type Culture Collection 25923), and then treated as follows: Group I: samples were immersed in 3% Hydrogen Peroxide Solution (n=30 fragments); Group II: samples were immersed in 3% Hydrogen Peroxide Solution with 70% Alcohol (n=30 fragments); Group III samples were immersed in 3% Hydrogen Peroxide Solution with 70% Alcohol and 500 mg/L Vancomicin solution (n=30 fragments). All solutions were sterile and the specimen size/mass relative to volume of solution were 1:10 (w/v). The incubation time was 15 minutes apiece and prior to each immersion, samples were washed with saline solution. After all, bioburden was collected for bacterial counting. Bone samples were also inoculated on tryptic soy broth (1:5 w/v) and solid media (Agar with 5% Sheep Blood), then incubated at 35 ± 2 °C for microbiological analysis. Bone samples (n=16 fragments) without Staphylococcus aureus contamination were used for negative controls and contaminated bone samples (n=14 fragments) without antiseptic solutions treatment, were used for positive controls.


Results

Growth in broth media is indicated by the presence of turbidity, specks, or flocculation in the medium while an uninoculated control remains clear and without turbidity after incubation. If the material tested causes turbidity of the medium, subcultures onto appropriate solid media were performed after incubation to decide if the turbidity is caused by the material only, or by microorganisms that have multiplied in the broth. After 48 hours of culture, all specimens of groups I and II had positive cultures (30 fragments of each group) on tryptic soy broth, and group III had significantly reduction in positivity (21 fragments) when compared to groups I, II and positive control, whereas no positive culture was detected in the negative control group. Interestingly, after 96 hours of culture, this positivity in group III was further reduced (14 fragments). It is probably due to the residual effects of the vancomicin antibiotic. To assess if there was a decrease in bacterial load between groups I, II and III, Student's t test was applied using the group I as standard population, with 1000 CFU/ml. The bioburden results showed that bacterial load was significantly reduced in group II, when compared to group I and positive control (p<0,05).


Conclusions

Although it did not have obtained 100% decontaminating in any analyzed group, the bioburden results showed significant reduction on the
bacterial load. The difficulties in obtaining full decontamination of bone surfaces can be explained by the high inoculum of S. aureus used for contamination, which is probably incompatible with in vivo real contamination. The association of three antiseptic solutions showed bacteriostatic effects and seems to be the best method for bone tissue decontamination.




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Emergency Management: A Burn Center's Relationship with their Tissue Dispensing Service

Primary Presenter: Stephen Williamson, BA

Primary Objective/Issue studied

The Shriners Hospitals for Children Tissue Bank purchases, stores, and distributes allograft skin grafts for pediatric burns at Shriners Hospitals for Children-Galveston (SHC-G) and for adult burns at the University of Texas Medical Branch-Galveston (UTMB). Both hospitals are verified burn centers through the American Burn Association (ABA).

Burns that are seen at both of these hospitals can vary from smaller burns (e.g. 10% Total Body Surface Area, TBSA) to larger burns (e.g. 99% TBSA). The types of burns can result from flames, scalds, or chemicals.

Historical data over the past three years shows that these two hospitals use an average of 650 square feet of allograft skin grafts per year.

What does a burn center do when a catastrophe happens and they are overwhelmed with large burns? How can you ensure that enough skin grafts are available? What happens when your tissue dispensing service is running low on inventory? This study will detail the events during multiple catastrophes as well as lists the solutions/recommendations for this scenario.


Abstract AATB 2013 Figure 1.docx
Abstract AATB 2013 Figure 2.docx

Project
Data from the years 2011 and 2012 shows the use of skin grafts at SHC-G and UTMB for January, February, March, and April (see ) ranged from 26 square feet to 73 square feet. In 2013, for the months of February, March, and April, skin graft use was 160, 253, and 247 square feet respectively. The dramatic increase in use of skin grafts corresponded with two major accidents that occurred in the regional area. The first accident involved three firefighters that were burned when a roof collapsed on them when they were trying to extinguish a fire. The second accident involved a fire at a gasoline refinery that injured 12 people.


Results Summary/Outcome/Implementation Strategy:

There were times when the inventory amount was questioned. Historically the inventory has been 200 square feet of skin. Most of this is non-meshed skin while approximately 30 square feet is meshed. While the meshed skin is preferred over the non-meshed skin, the non-meshed can be meshed in the operating room if needed. A drawback of meshing non-meshed skin grafts during surgery is the increase time of the surgery. For a burn patient, an increase amount of surgery is an increase amount of body heat loss as well as an increase in anesthesia.

Our first major accident (3 firefighters with major TBSA burns) occurred on a Saturday and all of our meshed skin was used during the initial surgeries. Additional skin was ordered, but it wouldn’t be shipped until Monday and wouldn’t arrive until Tuesday. During this time period, the use of non-meshed had to be utilized.

For the next two months there was constant communication with the O.R. and our tissue dispensing service. Communication with the O.R. was to help plan for the tissue needs that were projected for any upcoming surgeries. Our communication with the tissue dispensing service was to ensure that skin grafts were available. A review of tissue usage showed there were multiple days during this three month period where 20 to 30 square feet of skin grafts were used in a single day. This made things extremely difficult to keep up with the demands for meshed skin.




Lessons Learned/Author(s) Recommendation

The first lesson that we learned is that we needed to create a par level for our meshed skin inventory. We decided to set our par level at 50 square feet. This is in-line with the historic monthly average use of meshed skin. This amount would be sufficient in a worst case scenario to cover the needs for skin grafts for a two day period. This allows for additional tissue to be ordered and received before the meshed skin inventory is depleted.

The second lesson we learned is that constant communication with the OR and tissue dispensing service is needed. Planning ahead is critical even if sometimes you can only plan one to two days ahead. Being in constant contact with your tissue dispensing service is very beneficial to your success in planning. One must keep in mind that while you may have one or two major accidents that require a lot of skin grafts, there are also many other burn centers  around the country that are also dealing with major burns that need skin grafts. During the three month period of this review, the bombing in Boston occurred as well as the explosion at the fertilizer plant in West Texas. Letting your tissue dispensing service know your needs helps them get you the resources that are needed. Our tissue dispensing service was able to process more skin as meshed versus non-meshed to help meet our needs.   




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ESTABLISHING LAST SEEN ALIVE OR TIME OF DEATH THROUGH EXTRAORDINARY MEANS TO FULFILL FAMILY DONATION WISH

Primary Presenter: Heather L. Purvin, EMT-P, CTBS - In-House Coordinator

Background
Not Applicable

Primary Objective
Establishing positive proof of a terminal cardiac event or time "last seen alive" (LSA) is critical to the recovery of human tissues for transplantation in accordance with American Association of Tissue Banks Standards for Tissue Banking. This case presentation demonstrates the importance of OPO and hospital partner's extraordinary efforts taken to preserve family opportunity for a meaningful donation outcome.

Optional Text Area
Discussion: Referring hospital Emergency Department (ED) staff notified OPO at 1028 of a donor-designated 56 year old male patient who was pronounced dead at the hospital at 0951. The decedent's cardiac arrest was not witnessed and no cardiac rhythm was established in pre-hospital or ED resuscitation efforts. OPO needed to rely on a time the decedent was "last seen alive" (LSA) to start the clock on cooling and tissue excision. LSA as reported to the health care team (HCT) was 2000 on the previous day. Preliminary evaluation of the total uncooled time at the time of initial referral was 14.75 hours rendering the coordination of the surgical recovery within the acceptable time period impossible. The Tissue Coordinator (TC) spoke with legal next of kin (LNOK) via phone with assistance of HCT to affirm family support of donation and establish an accurate timeline of events concerning the death. LNOK confirmed LSA time as accurate, reporting that decedent was expected at her home by 0830 on date of death and when he failed to show, she went there and found him unresponsive. LNOK emphasized that decedent "had to be awake in the AM because there was a warm cup of tea on the counter" when she found him.

Summary / Outcome / Implementation Strategy
Implementation/Outcome: The TC directed family review of donor's cell phone record but found no calls or texts after established LSA (2000). Additional family conversation revealed the decedent had an implantable cardiac defibrillator (ICD) that had shocked him earlier in the week. The TC collaborated with the HCT to bring in a technician to interrogate the ICD to establish the decedent's terminal cardiac event. The ICD's Arrhythmia Episode Log documented numerous shocked ventricular tachycardia (VT) events starting 0759 to 0843 on the morning of the decedent's death. With new evidence obtained, 0843 was recorded as time of death. As result, the OPO was able to successfully recover corneas, musculoskeletal grafts and dermal skin for transplantation with a total uncooled time of just 6 hours. (see graph)



Conclusion / Author(s) Recommendation
Successful tissue recovery can happen in cases where cardiac arrest has occurred and LSA or uncooled time appears at first glance to be already out of standard by diligently sourcing all available information. Using innovative methods such as obtaining a decedent's ICD Arrhythmia Episode log to meet evidentiary requirements of donor acceptance criteria requires a committed, collaborative effort from the OPO and health care team at the referring donor hospital.



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Evaluation of the Impact of Removing the Smooth Muscle Relaxant, Papaverine, from Vascular Recovery and Processing on Tissue Viability and Function

Primary Presenter: Alyce Linthurst. Jones, PhD - Director, Cardiovascular Product Development

Background/Objectives

In 2011 there were concerns regarding the supply of papaverine that was required per AATB Standard D5.700 for procurement of blood vessels. Our industry has been dependent upon this drug for control of smooth muscle spasm during procurement of blood vessels. In 2012 an alternative drug, verapamil, was evaluated and determined to be suitable; however, Verapamil also became difficult to obtain. Therefore, the objective of this protocol was evaluation of the impact on tissue viability and function of removing smooth muscle relaxants from vascular recovery and processing.


Methods
Ten donors with research consent yielding bilateral saphenous veins and femoral arteries were recovered where one side was flushed, transported, and processed with papaverine (SMR group) and the opposite side was not (No SMR group). All vessels were disinfected, packaged, and cryopreserved according to AATB-compliant standard operating procedures. Vessels were thawed and diluted according to the instructions for use and each vessel was cut into 6, 2 mm ring segments for an organ bath analysis. Each vessel ring was mounted between two stainless steel wire hooks and suspended in a tissue organ bath. One hook was fixed to the bottom of the bath and the other was connected to a force transducer which recorded the isometric responses of the tissue to a panel of agonists and relaxants. Rings were equilibrated and pretested with potassium chloride before measurements were taken. Saphenous veins were treated with the agonists histamine and bradykinin and the relaxants acetylcholine and sodium nitroprusside while femoral arteries were treated with the agonists norepinephrine and phenylephrine and the relaxants sodium nitroprusside and acetylcholine. A Mann-Whitney Rank Sum test was used to analyze the data (SigmaPlot v11).

Results
The saphenous veins in the No SMR group demonstrated a statistically significant greater response to agonists than saphenous veins in the SMR group (histamine p<0.001; phenylephrine p<0.001). The saphenous veins in the No SMR group demonstrated a statistically significant greater response to two of the three relaxant drugs than saphenous veins in the SMR group (acetylcholine p<0.001; sodium nitroprusside p<0.001; bradykinin p=0.196). The femoral arteries in the No SMR group demonstrated statistically significant greater response to norepinephrine than femoral arteries in the SMR group (p<0.001). There was no statistically significant difference in response to the agonist phenylephrine for the femoral arteries recovered and processed with and without SMR (p=0.2). There was also no statistically significant difference in response to the relaxant drugs for femoral arteries recovered and processed with and without SMR (sodium nitroprusside p=0.949; acetylcholine p=0.32).



Conclusions
The removal of papaverine during recovery and processing did not adversely affect the quality of the saphenous veins or femoral arteries assessed by contraction/relaxation responses. Saphenous veins in the No SMR group had a greater response to agonists and two of three relaxant drugs than saphenous veins in the SMR group. Femoral arteries recovered and processed with or without papaverine performed similarly across all drugs; however, femoral arteries in the No SMR group had a statistically significant greater response to norepinephrine than the SMR group. It can be interpreted that the removal of papaverine from the recovery and processing of saphenous veins and femoral arteries retains endothelial and smooth muscle cell response to biologically relevant stimulus as well as or better than saphenous veins and femoral arteries recovered and processed with papaverine.



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First Person Authorization: When It's Not a 'Done Deal'

Primary Presenter: Stephanie Meister, RN, CTBS# 899107 - Senior Donor Coordinator

Primary Objective/Issue studied
To decrease the number of times the NOK rescinds First Person Authorization. First person authorization (FPA) allows an individual to designate his/her wishes about organ/tissue donation prior to death and gives recovery organizations legal authority to proceed without authorization from the donor’s family. However, in this tissue bank a Medical Social History (MSH) must be obtained prior to recovery of tissues. To decrease the number of rescinded (FPA) tissue cases where family refusal to complete MSH denies the donor wishes and decreases transplantable tissues an innovative training program was developed. FPA donors have increased 23% since 2009.

Project
A committee reviewed 2011 FPA statistics to determine unrecovered donors due to family refusal. Cases were identified and recorded conversations between Donor Coordinators (DCs) and families reviewed for conversation flow and common themes in family refusals. Reviews included DCs ability to blend family Bereavement Centered Care (BCC) while honoring donor wishes. A two hour small group training program was developed: oPreparation before the call-Case Review-FPA review-Limitations/restrictions.oDCs attention to Mind Set (attitude) to FPA -DCs personal reflection to FPA-DCs language/demeanor supporting decedent authorizationoBCC family conversation-Confirmation of FPA identification-Bereavement support-Donation process informationo Power Statements Identification: -I didn’t know ___ but he must have been a very caring person because he registered as an organ/tissue donor to help others through the gift of transplantation. -You are making many decisions, and John has alleviated one of these by making a decision for himself to be a tissue donor.-It isn’t uncommon that people aren’t aware that their loved one registered to be a donor. Death and dying is one of those issues that many people aren’t comfortable discussing.oRole Play: Initial family refusal -Identify and address family concerns-Offer explanation-Clarify rescinded decision

Results Summary/Outcome/Implementation Strategy:
Case review identified family reasons for rescinding:-Personal beliefs-Unaware of deceased authorization-Grief/ inability to complete MSH. Through feedback and audited FPA family recording post training DCs demonstrated increased level of understanding and gentle assertiveness to honor donor wishes. Family refusals decreased 50 from 13 to 5.75 in the 4 months following the training (see figure 1).



Lessons Learned/Author(s) Recommendation
Small group DC training to identify family concerns, foster DCs Mind Set, and teach Power Statements has a positive, direct correlation to family cooperation and increased recovered FPA donors.



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