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Continuity management in biobank operations: a survey of biobank professionals
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Continuity management in biobank operations: a survey of biobank professionals
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Content
CONTINUITY MANAGEMENT IN BIOBANK OPERATIONS:
A SURVEY OF BIOBANK PROFESSIONALS
by
Terry David Church
A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
December 2017
Copyright 2017 Terry David Church
2
DEDICATION
To everyone who have ever felt they were different.
Just remember…
Stars cannot shine without darkness!
3
ACKNOWLEDGEMENTS
One lesson I have learned while writing this dissertation, is that, in order to be successful
a doctoral thesis requires input, support, and encouragement from a wide range of people.
In my effort to bring this work to completion, I have benefitted from the guidance of
some amazing people, each of whom has contributed in his or her own unique way. In
1676 Isaac Newton wrote, “if I have seen further it is by standing on the shoulders of
Giants
1
”. The gravity of Newton’s words was something I did not fully appreciate until
sitting down to say thank you to everyone who has had a hand in shaping my academic
and professional worldviews.
I have been blessed with a community of supportive colleagues and teachers who have,
over the years, helped me hone the ideas presented in this dissertation. Among the most
important of these are my colleagues at the International Center for Regulatory Science at
the University of Southern California. No matter my need – great or small – they have
been generous with their time, attention, and candor. I am indebted to Randa Issa, Erin
Chow, Debbie Schroyer, Julie Lee, Laura Sturza, and Toni Rodriguez. Without your
support, I would not have been as disciplined, timely, or informed. I am also indebted to
faculty members Michael Jamieson, Eunjoo Pacifici, and Benson Kuo who challenged
me to think broadly and inspired me to channel my curiosity.
All of the work that this dissertation entailed would not have been possible without my
Dissertation Committee Chair, Frances Richmond. I will be forever grateful for your
mentorship, unfailingly patience, and belief in my ideas – especially when I was still
1
Scholars have recently debated that this statement written in a letter to Robert Hooke about his philosophical works was done in jest.
I mean it sincerely, as I believe it was originally intended by Newton.
4
unsure of exactly what those ideas were. I doubt this dissertation would have come to
fruition without your ongoing prompts of “how is it coming along” and ever-present
questions of “so what” along the way. Thank you for always challenging me to press on
and for pushing me towards a potential I did not even realize was possible. Though I
have not said it until now, thank you for believing in me. You have been the catalyst to
many changes in me, both professionally and academically. Who knows, one day, I may
surprise you by showing up in a tailored suit with a real tie! All jesting aside, I want to
thank you for sharing a lesson I will cherish and carry with me always. That lesson is
about being genuine to your purpose – relayed through the story wherein Inuit artisans
once told your father, “the soapstone does not want to be an owl”. You have made me a
better teacher, a more thoughtful scholar, and an even more passionate academic. A
million times would still not be enough to express my most sincere and heartfelt, Thank
You!
I am fortunate to have received extraordinary help, support, and guidance from my
dissertation committee. I appreciate Michael Jamieson, Kathleen Rodgers, and Sue Ellen
Martin for serving on my dissertation committee, but even more for your ongoing
mentorship and kindness. Thank you for your enthusiasm and thank you for your candid
feedback. My dissertation would have suffered greatly without your suggestions.
I am grateful to the leadership of the USC Norris Comprehensive Cancer Center – in
particular – the former director, Stephen Gruber, and the interim director, Alan Wayne,
who have been immensely understanding and supportive. I am very thankful for having
5
had the freedom to work on this dissertation, while simultaneously serving as program
manager for the Adolescent and Young Adult (AYA) cancers program.
Janet Villarmia, though you have moved to a new position, I want to thank you for being
the best boss a guy could have! You taught me to be transparent, to lead by example, to
be fair, and to not be afraid to take calculated risks. You have been an amazing mentor
and I hope one day to inspire others the way you have inspired me. Thank you for
believing in my abilities and for giving me the opportunity to shine.
I owe every bit of success I have had as a program manager, to Debasish “Debu”
Tripathy and Stuart “Stu” Siegel. You are scholars, teachers, mentors, and devoted
public servants. You continue to inspire me to follow and excel in civil service with a
compassionate heart and an active conscience to do the best for patients and the good of
all.
My career at USC Norris Comprehensive Cancer Center has challenged me to grow as a
leader and I am grateful for the opportunities I have been given. In 2015, my career took
a profound change when Stu Siegel retired after 46 years of service from USC. Prior to
retirement, Stu had created the Adolescent and Young Adult cancers program
(AYA@USC). Stu had identified abilities in me that I did not know existed. Before I
could protest his retirement, Stu had given me the responsibility of stewardship of
AYA@USC. Thank you for believing in my abilities, Stu!
Luckily, I am not alone in management of the AYA@USC program and I am
appreciative for my current CO (commanding officer), James Hu (co-medical director
6
AYA@USC), who reminds me on a daily basis to think tactically, deploy strategically,
and perform operationally. Thank you for always pressing me to be ever mindful of
ends, ways, and means. I would like to also thank David Freyer (co-medical director
AYA@USC) for trusting in my skills. I would also like to extend my deepest gratitude to
current and prior USC Norris Comprehensive Cancer Center colleagues – Heather
Macdonald, Charité Ricker, Yvonne Lin-Liu, Stefanie Thomas, Jan Huynh, Wendy
Cheng, America Casillas-Lopez, Laurel Barosh-Finster, Megan Bianchetti, Melissa
Wallman, Kaitlin Alderete, Tiffany Razzo, and Akshara Singareeka Raghavendra – for
always bending an ear, acting as informal counsel (or part-time therapist), and
entertaining my quirky ideas no matter how mundane or silly they may be.
This dissertation is the culmination of a long educational path that has taken 41 years to
complete. My family likes to jokingly call me their “eternal student”. Along this path
my parents have been unfailing in their support and love. During the busy years of
graduate study, they have shown their love by encouraging me ever forward. My father,
Leo Franklin Church, taught me to dream and my mother, Judith Rose Church,
encouraged me to live those dreams. Additionally, I could not have completed this
project without the support and good-hearted harassment from my five older siblings -
Denise, Debbie, Tina, Tim, and Tammy. The support from my siblings, their wonderful
families and my amazing nieces and nephews has been outstanding – thank you all! To
my 3 brothers-in-law’s, 1 sister-in-law, 5 nieces, 8 nephews, 7 great-nieces, and 5 great-
nephews – wow, there are a lot of us – thank you for always encouraging me to “get ‘er
done”, even if at times you were not exactly sure what I was getting done!
7
The heart and soul of my dissertation is dedicated to my caring and understanding partner
of 14 of the happiest years of my life, Daryl Stephen Evans. Despite the sacrifices asked
of you so I could pursue this degree, you have never once expressed regret. You have
encouraged and inspired me all along the way, and when I thought I would not have the
strength to finish you let me lean on you. You were there at 2AM telling me to go to bed,
you made dinner when I had deadlines to meet, and you have always been there to listen,
even if the subject material was boring – whether wanted or not, you are now as much an
expert in biobank continuity as I am. I have never had a bigger cheerleader. None of my
academic endeavors would have been possible without your fathomless well of continued
support.
To my new-found brothers, Cyclepath Cycling Team, I want to thank all 37 of you for
helping me find an inner strength this year that I did not know I possessed. I am
confident that our 545-mile ride for AIDS/Lifecyle will not only be successful, but
memorable. Thank you for insisting I push through and reminding me that demanding
work requires snacks.
To my adopted cohort, the DRSc cohort of 2014. “Xie xie”, “domo arigatou”,
“kamsahamnida” for allowing me to crash your class trip to Asia in 2015. The warmth,
hospitality, and comradery you all showed was so very much appreciated. I want to
thank the following people, in particular – my adopted sisters, Jennifer “Pokey” Wiley
and Penny “Ping Ping” Ng; the person I love to get lost with (on purpose), Michelle Mc
Guinness; my “Didi”, Sunita Babar; and to the amazing bargaining skills of Darren
8
Oppenheimer. I will gladly always be the annoying little brother you never had, but
always wanted!
Last, but by no means least, I want to say thank you to my doctoral cohort – the 15
members of 2012. Together we have laughed, cried, traveled, grown, and managed to
“leave no schnitzel uneaten” (Smerkanichisms – DRSc cohort 2012; class trip to Europe
in 2014). I am fortunate and rich in spirit for having had the opportunity to get to know
each and every one of you. I owe a debt of gratitude to Nancy Pire-Smerkanich for
always being a great counsel (particularly over tacos), for giving me the honor of guest
lecturing every semester, and for your uncanny way of always knowing when I needed
someone to talk to about life. From the bottom of my heart, I want to thank a few of my
cohort mates and new found family; specifically I would like to thank – Caroline
Mosessian who fortified my resolve and kept me looking ahead; Aimee Greco for
renewing my competitive spirit and lending me your strength; Martha Kamrow for
reminding me to lighten up and have a good time; Cesar Medina for insisting “everything
is awesome” and never compromising; Vada Perkins who reassured me that not
everything can be scripted in “storyboardezes”; Susan Pusek for reminding me to breathe
and listen to my heart; Grant Griffin who reminded me to reward hard work with an
occasional pint; and Ali Reza Rajaei for encouraging me to explore off the beaten track.
As you have no doubt surmised, I am overwhelmed with gratitude to everyone who has
been along with me through the dissertation writing process, or as I refer to it my crazy
walk-about in “biobankland”. Thank you for encouraging me along this path. It has been
amazing and I am so fortunate for the experiences afforded by this journey!
9
TABLE OF CONTENTS
DEDICATION .................................................................................................................... 2
ACKNOWLEDGEMENTS ................................................................................................ 3
TABLE OF CONTENTS .................................................................................................... 9
LIST OF TABLES ............................................................................................................ 13
LIST OF FIGURES .......................................................................................................... 14
ABSTRACT ...................................................................................................................... 16
CHAPTER 1. OVERVIEW ...................................................................................... 17
1.1 Introduction .................................................................................................. 17
1.2 Statement of the Problem ............................................................................. 20
1.3 Purpose of the Study .................................................................................... 21
1.4 Importance of the Study ............................................................................... 21
1.5 Limitations, Delimitations, Assumptions ..................................................... 22
1.5.1 Delimitations .................................................................................. 22
1.5.2 Limitations ...................................................................................... 23
1.5.3 Assumptions ................................................................................... 25
1.6 Organization of the Thesis ........................................................................... 25
1.7 Definitions .................................................................................................... 26
1.7.1 Acronyms ....................................................................................... 27
10
CHAPTER 2. LITERATURE REVIEW .................................................................. 29
2.1 Introduction .................................................................................................. 29
2.2 Background to Literature Review ................................................................ 31
2.2.1 History of Biobanks ........................................................................ 34
2.2.1.1 Biobank History in the American Experience ................... 36
2.2.2 Function of Biobanks ...................................................................... 38
2.3 Disaster Management and Continuity Planning ........................................... 46
2.3.1 Defining Catastrophes .................................................................... 51
2.3.1.1 Hurricane Katrina .............................................................. 53
2.3.1.2 Superstorm Sandy .............................................................. 56
2.3.2 Continuity ....................................................................................... 59
2.4 Risk Assessment and Response ................................................................... 61
2.4.1 Resilience and Sustainability .......................................................... 65
2.5 Historical Context Informing Guidance in the United States ...................... 70
2.5.1 Legislation Related to Continuity Planning .................................... 71
2.5.2 Laws More Specific to Biobank Continuity ................................... 76
2.5.3 Standards and Guidance Documents Specific to Biobank
Continuity ....................................................................................... 78
2.5.4 NCI Best Practices .......................................................................... 79
2.5.5 ISO Standards ................................................................................. 80
2.6 Additional Guidelines from International Sources ...................................... 82
11
2.7 Synthesis of Literature Review .................................................................... 85
CHAPTER 3. METHODOLOGY ............................................................................ 91
3.1 Introduction .................................................................................................. 91
3.2 Phase I: Survey Instrument Creation ........................................................... 91
3.3 Phase II: Focus Group Critique of Survey Instrument ................................. 92
3.4 Phase III: Administration and Data Collection of Survey Instrument ......... 94
3.5 Analysis of Data ........................................................................................... 95
CHAPTER 4. RESULTS .......................................................................................... 97
4.1 Analysis of Survey Responses ..................................................................... 97
4.2 Demographic Profiles .................................................................................. 97
4.2.1 Respondent Profiles ........................................................................ 97
4.2.2 Biobank Profile ............................................................................. 100
4.2.3 Profile of Disaster Vulnerabilities ................................................ 105
4.3 Research and Development Implementation Phase ................................... 108
4.3.1 Barriers and Hurdles During Research and Development ............ 108
4.3.2 Standard Operating Procedures to Incorporate Continuity ........... 113
4.3.3 Crises and Disasters Considered for Continuity Planning ............ 117
4.3.4 Guidance Documents Referenced During Continuity Plan
Development ................................................................................ 120
4.4 Evaluation of Continuity Plan .................................................................... 123
4.4.1 Formal Review Process ................................................................ 123
12
4.4.2 Evaluation of Continuity Plan ...................................................... 125
4.4.3 Training as part of Continuity Planning ....................................... 130
4.5 Future Thinking on Continuity Regulations .............................................. 134
4.6 Other Analyses ........................................................................................... 137
4.6.1 Cross-Tabulation of Demographic Factors ................................... 138
4.6.2 Cross-Tabulation of Evaluation Phase .......................................... 139
CHAPTER 5. DISCUSSION .................................................................................. 140
5.1 Overview .................................................................................................... 140
5.2 Methodological Considerations ................................................................. 141
5.2.1 Delimitations ................................................................................ 141
5.2.2 Limitations .................................................................................... 142
5.2.2.1 Respondent Participation ................................................. 142
5.2.2.2 Use of Survey Methods ................................................... 145
5.3 Consideration of Results ............................................................................ 147
5.3.1 Early Stages of Implementation: Exploration ............................... 148
5.3.2 Intermediate Stages of Implementation: Initial Implementation .. 156
5.3.3 Mature Stages of Implementation: Full Implementation .............. 160
5.3.4 All Stages of Implementation: Recurring Challenges .................. 162
5.4 Future Directions and Concluding Thoughts ............................................. 164
REFERENCES ............................................................................................................... 167
APPENDIX A. BIOBANK CONTINUITY SURVEY ............................................ 191
13
LIST OF TABLES
Table 1: List of Key Terms Defined ..................................................................................26
Table 2: List of Abbreviations ...........................................................................................27
Table 3: Select Key Term Searches from Citation Search Engines ...................................32
Table 4: Cost of Recent United States Disasters ...............................................................57
Table 5: Post-9/11 Guidelines and Regulations Landscape ...............................................74
Table 6: Survey Focus Group Members ............................................................................93
Table 7: Reported Collections - Current and Future (N=43) ...........................................102
Table 8: Elements Reported as Included in SOPs (N=27) ...............................................114
Table 9: Crises Considered and Incorporated in Continuity SOPs (N=32) .....................117
Table 10: Respondent Comments Regarding Developing Continuity Plan (N=10) ........122
Table 11: Regarding Additional Elements Considered During Evaluation of the
Continuity Plan (N=7) .............................................................................129
Table 12: Other Training Methods Incorporated by Respondents...................................133
Table 13: Experience with Regard to the Implementation or Evaluation of the
Continuity Plan ........................................................................................133
Table 14: Concerns of Respondents Regarding Future Biobank Continuity
(N=32) ......................................................................................................135
Table 15: Cross-Tabulation of Facility Type and Years of Experience (N=45)..............138
Table 16: Cross-Tabulation of Natural Disasters and Continuity Plan (N=45) ...............139
Table 17: Cross-Tabulation Facility Type and Formal Improvements (N=32) ...............139
14
LIST OF FIGURES
Figure 1: "Surgeon's" Temple of Sobek .............................................................................35
Figure 2: Biobank Transactional Process ..........................................................................45
Figure 3: Ishikawa Diagram of Organizational Crises ......................................................48
Figure 4: Iterative Model for Hazard Risk Reduction .......................................................63
Figure 5: Biobank Resilience Adaptive Model ..................................................................67
Figure 6: Model of Adaptive Resilience ............................................................................68
Figure 7: Stages of Implementation Framework ...............................................................87
Figure 8: Implementation Drivers ......................................................................................88
Figure 9: Respondent Reported Facility Type (N=45) ......................................................98
Figure 10: Job Roles of Respondents (N=45) ....................................................................99
Figure 11: Years in Biobanking (N=45) ............................................................................99
Figure 12: Respondent-Reported Department Size (N=45).............................................100
Figure 13: Purpose for Biobanking reported by Respondents (multiple choice
permitted) (N=75) ....................................................................................101
Figure 14: Reported Specimen Collection - Current and Future (N=43) ........................103
Figure 15: Years of Biobank Operation Reported by Respondents (N=45) ....................104
Figure 16: Biobanks Reported in Potential Disaster Areas (N=45) .................................105
Figure 17: Identification of Biobank Vulnerability to Potential and Experienced
Disasters (N=15) ......................................................................................106
Figure 18: Presence or Absence of a Biobank Continuity Plan (N=46) ..........................107
Figure 19: Length of time for which a Continuity Plan Years Has Operated
(N=36) ......................................................................................................108
15
Figure 20: Hurdles During Research and Development of Continuity Plans (N=6) .......111
Figure 21: Biggest Hurdles During Development (N=6) ................................................112
Figure 22: Reported Number of Standard Operating Procedures (N=41) .......................113
Figure 23: Elements Considered and Incorporated into Continuity SOPs (N=27) ..........116
Figure 25: Disaster Elements Incorporated Vs. Not Incorporated (N=32) ......................119
Figure 24: Disaster Elements Considered in Continuity SOPs (N=32) ...........................119
Figure 26: Reported Awareness and Utilization of Guidance (N=29) ............................121
Figure 27: Timing of Updates to SOPs to Incorporate Improvements (N=33) ...............124
Figure 28: Life-Cycle Elements Incorporated into Continuity Plans (N=5) ...................125
Figure 29: Level of Consideration to Various Elements Important for the
Evaluation of the Continuity Plan (N=32) ...............................................127
Figure 30: Level of Consideration Given to Items During Evaluation of
Continuity Plan (N=32) ...........................................................................130
Figure 31: Frequency with Which Personnel Are Trained on Content of
Continuity Plans (N=32) ..........................................................................132
Figure 32: Future Elements of Concern for Biobank Continuity (N=32) ........................136
16
ABSTRACT
Academic biobanks face a number of challenges that call out for continuity and disaster
planning. Because current regulations do not require such planning, it is unclear if and
how biobanks have prepared themselves to deal with those future crises. This
exploratory study utilizes mixed methods to understand the state of continuity planning in
United States biobanks. This study first reviewed the current state of regulatory and
implementation requirements that drive and challenge continuity planning. A survey
instrument was then developed and critiqued by a focus group of experienced
practitioners in the biobanking sector. The refined survey was disseminated to a targeted
group of respondents employed at biobanks across the United States. Most respondents
were associated with relatively mature biobanks in operation for more than six years and
these typically had a continuity plan in place. Respondents identified financial resources
as their most common limitation affecting all phases of implementation. More commonly
those efforts seemed to be focused on countering natural disasters rather than
organization or personnel-related crises. While many respondents reported that they were
aware of guidance documents and standards, a surprising proportion had reported that
they did not use or reference them when constructing their biobank continuity plans.
Important areas of interest for future biobank continuity studies are in the areas of
training, best practices, and organizational sustainability.
17
CHAPTER 1. OVERVIEW
1.1 Introduction
Over the past two decades, access to human tissue and fluids has become central to the
success of “precision medicine”. Precision medicine is an approach that attempts to tailor
treatment to the needs of individual patients according to the individual’s genetic or
phenotypic features. However, such an approach relies on the use of biologic samples, so
that research or clinical interventions can associate the diagnoses or treatments with
greater or lesser success in subpopulations with specific attributes. To supply the
necessary biologic samples, specialized facilities called biobanks have been created that
can preserve and curate not only a range of biologic materials including cells, blood,
tissues, organs, ova, sperm, ascites, and saliva, but also the associated background
information related to the tissue donors.
Biobanks come in a diversity of sizes and structures, from large genetic databases on
hundreds of individuals to small collections specializing in single diseases. Their size
and operational characteristics vary over time with changes in staffing, funding sources,
administrative support, research interests, ethical concerns, storage issues, and affiliations
with larger organizations, for example (Cadigan, Edwards, Lassiter, Davis, & Henderson,
2017). In order to serve as an effective research resource, biobanks require a tremendous
investment of capital to support the necessary infrastructure and personnel (Barbareschi,
Fasanella, Cantaloni, & Giuliani, 2013; Caulfield et al., 2014; Marko-Varga, Baker, Boja,
Rodriguez, & Fehniger, 2014; Vaught, Rogers, Carolin, & Compton, 2011). Biobanks
take years to amass collections and data, during which time their survival can be
18
compromised by the vagaries of funding and level of expertise / employee leadership.
They can also be compromised by other challenges such as personnel loss, corruption, or
disaster. Part of the art to sustaining a biobank resides in the ability to anticipate and
respond appropriately to these challenges in order to maintain continuity of operations.
The use of biobanks has introduced many types of new concerns for investigators,
biobank operators, and regulatory bodies. The considerations that have received the most
attention have typically been those challenges posing immediate logistical and legal
concerns. A bulk of the existing literature focuses on the immediate scientific concerns
related to specimen preservation and management. A fair amount of the research has also
concentrated on the ethical and social issues related to challenges including management
of informed consent, ownership issues, privacy concerns, or management and
communication of genomic incidental findings. What has not been as widely discussed
are the challenges of continuity planning, vital for maintaining and managing a biobank
over the long term.
What little attention has been paid to biobank continuity in the United States exists
primarily as best practice guidance documents. These best practices suggest that
biobanks should incorporate elements into their daily procedures for operational activities
relating to quality control, security measures and storage standards (Cadigan et al., 2013).
Perhaps the most comprehensive of these documents is the latest version of the best
practice guidance for biobanks from the National Cancer Institute’s (NCI) Biorepositories
and Biospecimen Research Branch (BBRB). This document sets the minimum
acceptable operational methodology for the “technical, operational, and ethical, legal, and
19
policy best practices in order to ensure a level of consistency and standardization across
biospecimen resources” (NCI, 2014). It provides rich, albeit high level, detail on the
establishment of a biobank and the maintenance, collection, storage, annotation, and
retrieval of its biospecimens. The content functions as a general blueprint to assist
biobanks in achieving a stable operational state. However, it does not provide process or
implementation methodologies that would assist biobanks in the long-term management
of their collections. Let alone their immediate day-to-day operations. Thus, each
biobank appears to develop its own terms and practices to govern its institutional
operation. At the present time, there exists no provision to synchronize best practices
from one biobank to another within the United States.
Despite this apparent paucity of guidance, biobanks clearly need to plan for longer-term
sustainability in ways that improve resilience in the face of any number of potential
threats. A few Federal and International guidance documents discuss certain narrow sets
of activities in which planning would be expected. Natural disasters, man-made crises
and other similar threats are approached, albeit, very broadly. To date, the majority of
these documents do not offer systematic ways for organizations to approach continuity
across different lifecycle stages or geographic locations. For example, little has been
written or required in terms of risk analysis and risk management, a cornerstone of
continuity management in other industries (Davies et al., 2015; see Zou, Chen, & Chan,
2010, for a more detailed review). Biobanks can learn from continuity planning in other
fields, such as business, information technology, and civil defense (Asplund, Nadjm-
Tehrani, & Sigholm, 2008; Gupta, 2014; Hatton, Grimshaw, Vargo, & Seville, 2016).
20
Planning phases must recognize and account for specific challenges, such as, size, local
context, and institutional culture introduced by the nature of biobanking operations itself.
A static one-size-fits-all continuity plan is much less likely to be useful. A dynamic
framework that guides each biobank to prepare and implement appropriate strategies in
anticipation of likely challenges would be a much more valuable document. At the very
least, a checklist of items to consider at key implementation stages would be ideal.
1.2 Statement of the Problem
Amid the regulations, best practices, and guidelines related to biobanking, there exists
little information related to continuity plans. Even less discussion has related to the
implementation of such plans and associated methods for overcoming potential
challenges along the way. Currently, there exists no preferred method, direction nor
consensus on how biobanks should be incorporating continuity plans. Further, little
information exists about the nature and adequacy of the approaches and practices in use
by biobank administrators who are tasked with planning for long-term continuity. Best
practice guidelines for biobanks suggest that biobanks create a business plan to account
formally for their operational functions and costs (NCI, 2014; OECD, 2009).
Surprisingly, there is no central document that biobanks can access to inform continuity
practices across the implementation lifecycle.
Two general questions will function as way posts throughout the research presented
within this dissertation:
21
• At what stage of implementation are biobanks operating at within the United
States?
• To what extent are barriers or challenges in implementation preventing biobanks
from effective continuity planning?
1.3 Purpose of the Study
The study proposed here attempts to gain insight into the nature and adequacy of
continuity planning and implementation amongst biobanks in the United States in the
absence of defined regulations. In the literature review that follows, the development of
thought, recent experiences and current state of regulations and guidances related to
biobank continuity is catalogued. A survey tool has been developed to aid in the
examination of key aspects of continuity implementation, using a framework suggested
by Fixsen to identify challenges during the stages of implementation (Fixsen & Blase,
1993/2009, Fixsen et al., 2009). The survey will be distributed to biobank staff,
managers, and administrators. These methods should identify the implementation stage
and challenges faced by biobanks as continuity has been explored, installed,
implemented, and sustained. The goal is to develop a composite of current practices to
achieve continuity planning in a regulatory environment where guidance documents are
sparse and a standard method implementation has not been mandated.
1.4 Importance of the Study
The investigation of the research questions and subsequent analysis of collected data will
increase existing knowledge regarding planning and management of continuity activities.
22
The systematic data from the cross-section of biobanks developed here will provide
perhaps the first composite portrait of how biobanks, at various stages of implementation,
are dealing with issues of continuity and disaster planning. The focused data should
inform those who make policy and regulations locally, nationally, and internationally
about areas where education, guidance, and standards may be needed to help protect
biobanks and the collections they contain. As a benchmarking exercise, the study should
help, at a minimum, biobank operators to assess their own approaches compared to the
approaches of similar organizations. The survey results could be utilized to add to
existing knowledge related to continuity practices. This additional knowledge could be
of use to biobank administrators, regulatory professionals, policy makers, and
researchers, who may be tasked with any facet of biobank continuity planning.
Additionally, it is hoped that this review of data will provide valuable insights into the
approaches that some biobanks might have utilized to overcome challenges along the
continuity implementation lifecycle.
1.5 Limitations, Delimitations, Assumptions
1.5.1 Delimitations
This research was delimited in time, space, and scope. The captured data represented a
snapshot of the policies, practices, and beliefs related to biobank development and
continuity management in a timeframe between 2015 and 2017. Because this study was
not designed to track the biobanks prospectively, it will not be able to predict trends
related to biobanking that will arise over time unless the decision is later made to
reevaluate the same group of responding organizations.
23
The study was delimited to biobanks in the United States. It was further delimited to
foundational research institutes, academic research centers and their affiliated university
or military hospitals who were willing to participate in an anonymous survey. The focus
on academic based biobanks reflected research findings from a Duke University survey
(Uzarski, Burke, Turner, Vroom, & Short, 2015) that stated about two-thirds of identified
biobanks have some sort of formal affiliation with academic entities. The bulk of
biobank activities may have occurred in academic centers that have some similarity in
their institutional organization, driven by the adoption of Federal Wide Assurances
(FWA) at most major academic centers. Private biobanking companies were excluded
from the study for two reasons. First, there could exist a heterogeneity of regulatory
practices in the two types of organizations that could have skewed the analysis. Second,
biobank practices of private companies may be viewed as proprietary, confidential, or
containing trade secrets. Such a view could have limited how respondents answered (or
did not answer) some survey questions.
The survey was distributed only to managers and operators of biobanks and not to other
stakeholder groups, including patients or secondary users. The views of the “customers”
who contributed to and utilized biobank resources would be valuable to know, but the
scope of such data collection exceeded the reach of this study.
1.5.2 Limitations
A number of real and potential limitations impacted this study. The information collected
in regard to continuity practices of biobanks may have been seen as proprietary and in
some instances privileged, even in academic organizations. Based on this, some
24
respondents may have been reluctant to share information. To the greatest extent
possible this limitation was addressed by assuring that the information was anonymized
and that the questions were asked in a way that avoided requesting what might be seen as
protected proprietary information. Nevertheless, some respondents may have had
concerns about the questions that lead them to abort survey participation.
A further limitation of the study was related to the development and use of a novel survey
tool. To the knowledge of the author, no formal survey tool has been used by any other
researcher to date in an attempt to understand the stages of implementation of biobank
continuity practices. A survey on biobank utilization as a core service within academic
institutions held some merit with regard to general background (Goldenberg et al., 2015)
However, as identified by Gibbons (2009), all survey tools are open to concerns of
validity. Surveys capture the perceptions of respondents at specific moments in time,
with only a few survey constructs considering how different backgrounds and factors
might have influenced opinions on policy (Master, 2015). These concerns may have
been especially problematic when a survey is developed by researchers who have not
been engaged in research about this topic in the past. The use of a focus group helped to
qualify the face validity of the survey, but surveys often have hidden bias that can be
difficult to remove. The use of an implementation framework helped to assure that
several areas of continuity planning and procedure development were examined.
Nevertheless, the use of such a framework may have limited the extent to which insights
were gained into other aspects of planning, if they did not appear explicitly in the
framework utilized.
25
An often-serious limitation was related to the difficulty in engaging biobank personnel as
respondents. Individuals may have attempted to finish the survey quickly by giving
superficial answers. Efforts were made to minimize superficial answers by restricting the
number of questions in the survey, but a short survey limited the depth and breadth of the
questions that were posed. It was even possible that one or more respondents provided
false answers if they felt that the questions reflected badly on their capabilities or
professionalism.
1.5.3 Assumptions
A central assumption of this dissertation was that the literature reviewed was adequate to
support analysis and discussion related to the findings of the research. It was further
assumed that individuals who participated had an adequate knowledge base and offered
informed and honest opinions as related to their biobanking experiences.
1.6 Organization of the Thesis
This study is presented in five chapters. Chapter 1 provides an overview of the study,
presents the key research questions, and defines the known limitations of the research
plan. Chapter 2 outlines the historical and current contexts related to risk assessment,
continuity management, disaster planning, and sustainability of biobanks to clearly frame
the issues at the heart of the problem. Chapter 3 details the methodology used to
investigate the research questions, including a discussion of the development,
implementation, and analysis plan for the survey. Chapter 4 describes the analysis of
data and treatment of information as delineated in the methodology section. Chapter 5
26
concludes the study by providing a critical discussion of the data, as well as candid dialog
or the relevance of the findings and potential applications for other studies and disciplines
of thought.
1.7 Definitions
For ease of understanding, the following definitions of the key terms utilized within this
dissertation are defined below in Table 1.
Table 1: List of Key Terms Defined
The List of Key Terms Defined Table was compiled, unless otherwise cited, from
Merriam-Webster online dictionary (www.meriam-webster.com) by utilizing the search
word functionality for each term in the table above.
Key Term Description
Biobank A large collection of biological or medical data and tissue
samples, amassed for research purposes.
Contingency An event or condition of being that is likely but not inevitable.
Dependent on other conditions or circumstances; conditional.
Continuity The unbroken and consistent existence or operation of
something over a period of time. A state of stability and the
absence of disruption.
Disaster An alarming situation, used to refer to emergencies, crisis,
critical events, terrorist attacks, technical accidents, and alike
events having adverse impact.
The United Nations International Strategy for Disaster
Reduction (UNISDR), definition is a serious disruption of the
functioning of a community or a society involving widespread
human, material, economic or environmental losses and
impacts, which exceeds the ability of the affected community or
society to cope on its own resources (UNISDR, 2005).
Resilience An ability to recover from or adjust easily to misfortune or
change.
27
1.7.1 Acronyms
The acronyms and abbreviations associated with biobanking and research are quite
extensive. Therefore, all abbreviations used throughout this document are defined below
in Table 2.
Table 2: List of Abbreviations
Abbreviation Definition
AIDS Auto-Immune Deficiency Syndrome
BP Best Practice
BBP Biobank Best Practices
BBRB Biobanks and Biospecimen Research Branch
BCE Before Current Era
CAP College of American Pathologists
CBO Congressional Business Office
CE Current Era
CEO Chief Executive Officer
CLIA Clinical Laboratory Improvement Act
DNA Deoxynucleic Acid
DRSc Doctorate of Regulatory Science
ELSI Ethical, Legal, and Social Implications
EMA European Medicines Agency
EU European Union
FCPA Foreign Corrupt Practices Act
FDA Food and Drug Agency
FDPA Flood Disaster Protection Act
FEMA Federal Emergency Management Agency
Key Term Description
Sustainability Of, relating to, or being a method of harvesting or using a
resource so that the resource is not depleted or permanently
damaged.
28
Abbreviation Definition
FWA Federal Wide Assurances
HFA Hyogo Framework for Action
HIPAA Health Information Portability and Accountability Act
HIV Human Immunodeficiency Virus
HSC Health Science Campus
ISBER
International Society for Biological and Environmental
Repository
ISO International Organization for Standardization
LSU Louisiana State University
NCCC Norris Comprehensive Cancer Center
NCI National Cancer Institute
NIH National Institutes of Health
NIMS National Incident Management System
NOTA National Organ Transplant Act
NRC Nuclear Regulatory Commission
NYSE New York Stock Exchange
NYULMC New York University Langone Medical Center
NTIA National Telecommunications and Information Administration
OBBR Office of Biorepositories and Biospecimen Research
OECD Office for Economic Cooperation and Development
OMB Office of Management and Budget
OPTN Organ Procurement Transportation Network
PAHP Pandemic and All Hazard Preparedness Act
PDD Presidential Decision Directive
SOP Standard Operating Procedure
SRTR Scientific Registry of Transplant Recipient
UAGA Uniform Anatomy Gift Act
UN United Nations
UNISDR United Nations International Strategy for Disaster Recovery
USC University of Southern California
WWII World War II
29
CHAPTER 2. LITERATURE REVIEW
2.1 Introduction
Our world is becoming increasingly technically sophisticated. We rely on integrated
power and digital networks to maintain many business processes. In recent years, events
such as hurricanes, tsunamis, earthquakes, power outages, acts of terror, and pandemics
have highlighted the vulnerability of these complex systems to disaster. Undesirable
human intrusions or interventions, such as workplace invasions, assaults with
semiautomatic or explosive weapons, computer hacking, data falsification, intended and
unintended release of confidential information, theft of products, or the demands for the
ransom of stolen data, have become risks that can damage individual businesses or
compound ongoing and concurrent disasters (Bonanno, 2016; Valach, 2016).
Unmanaged, these risks result in loss: loss of revenue, of reputation, of information, of
access to facilities, and of personnel (Coaffee & Rogers, 2008; Cook, 2015).
Biobanks are particularly vulnerable to both unpredictable, longer-term hazards such as
those listed above, and more specific near-term hazards, such as damage to research
samples or challenges around data integrity and privacy. However, it has been the
specific, near-term hazards that have dominated the agenda of the biobanking
community. Regulatory and ethical issues, such as the management of informed consent,
patient confidentiality, management of incidental findings, and logistical issues related to
medical reporting and business practices, for example, have been studied extensively
(Garay & Gray, 2012; Luo et al., 2014). The narrow focus on immediate needs can
crowd out considerations of long term management. This chapter refocuses the lens onto
30
the less-studied longer-term view of biobank organizations and continuity, with a
particular emphasis on the ways disasters can affect operations and the planning measures
that have been taken for recovery.
The term biobank, in this chapter, applies to a range of organizational groupings, mostly
housed within academic medical centers; these can include disease-specific groups,
departments, divisions, teams, and academic cores, irrespective of the biobank scope and
scale and whether they are locally or collaboratively linked. Biobanks can vary in size
and can be narrow or broad in the way they cover different scientific disciplines. This
breadth is reflected in the range of publications related to biobanks that can be found in
journals of clinical chemistry, pathology, epidemiology, genomics, proteomics,
anthropology, sociology, as well as other diverse areas of basic, translational, clinical and
population research (Vaught, 2016). They can be either academic facilities or private
businesses. Academic biobanks share some generalized features including a commitment
to education, adherence to regulations governed by the Common Rule, and transparency
in conflict of interest pursuant to the Government in Sunshine Act (ACUS, 1976/2014).
These similar qualities make academic biobanks accessible and easier to group in order to
generalize findings. Private biobanks may have different priorities, operate under
varying regulatory frameworks, and regard their practices as proprietary. Thus, the
present study is directed at understanding practices across a variety of organizational
models.
31
2.2 Background to Literature Review
In an effort to establish the current state of the art of biobank continuity planning and
management, it was important to review literature concerning a variety of continuity
topics across disciplines within the publicly available materials. Using United States
National Library of Medicine database, PubMed.Gov, and the optimized search engine
Google Scholar (scholar.google.com), a literature search was conducted with the goal of
obtaining journal articles, legal briefs, scientific publications, books, internet references
and conference presentations that cover the continuity of biobank operations. Key word
searches, including disaster management, continuity planning, closure, and contingency,
were identified as the most helpful terms in building the literature review as detailed in
Table 3 below. Any publications dealing with quantitative or qualitative approaches to
business continuity, emergency, disaster, or crisis, as well as, documents dealing with
“biobank operations” and “biobank management” were included. Publications in
English, German, French, and Italian were collated in the first pass; of the 14 foreign
articles retrieved only 6 were utilized in this dissertation. All of the foreign articles have
English translations available online and have subsequently been referenced in their
English formats. For the purposes of the literature review, citations that dealt with
continuity of operations specific to biobanks, biorepositories or biocollections were
retained and many have been summarized in the literature review that follows. Excluded
from review were conference agendas, educational catalogs, abstracts without specific
information on continuity management, blog entries, and general articles related to non-
human biobanks (primarily those dealing with animal, veterinary, or botanical
32
collections). In addition, internet-based search engines (Bing
2
and Google
3
) were
employed to look for presentations that have been made on this topic; those have been
incorporated into the review below. It is noteworthy to mention that the topic of biobank
continuity of operations is a relatively new discussion in the United States. Thus, the
current thinking of NIH and FDA with regard to the need for business continuity and
disaster management was only discussed in detail in slides and abstracts from
presentations and a few cursory remarks within best practice documents. FDA, NIH, and
EMA websites provided some additional content related to projects they are undertaking
to develop business continuity methodologies.
Table 3: Select Key Term Searches from Citation Search Engines
Data shows selected search phrases used in citation search engines, PubMed
(http://www.pubmed.gov) and Google Scholar (http://scholar.google.com). The results
from the search within this table were conducted on 16 February 2016.
Key Terms PubMed
Google
Scholar
Biobank, Biobanking, Biorepository 3,410 31,810
Biobank Continuity, Biobanking Continuity,
Biorepository Continuity
4 2,574
Biobank Disaster, Biobanking Disaster, Biorepository
Disaster
15 3,168
Biobank Crisis, Biobanking Crisis, Biorepository
Crisis
8 4,825
Biobank Closure, Biobanking Closure, Biorepository
Closure
37 2,705
Tissue Bank, Tissue Repository 8,475 850,800
Tissue Bank Continuity, Tissue Repository Continuity 16 38900
Tissue Bank Resilience, Tissue Repository Resilience 3 19,880
2
http://www.bing.com
3
http://www.google.com
33
Key Terms PubMed
Google
Scholar
Tissue Bank Disaster, Tissue Repository Disaster 23 30,390
Tissue Bank Closure, Tissue Repository Closure 44 55,000
Tissue Business Continuity Management, Tissue
Business Continuity Planning
2 33,900
Tissue Risk Management 23,662 1,370,000
Blood Bank, Blood Repository 12,387 707,000
Biobank Best Practices, Biobanking Best Practices,
Biorepository Best Practices
119 29,480
Tissue Bank Best Practices, Tissue Repository Best
Practices
106 37,500
Totals 48,318 3,255,902
Based on the key words in any combination, over 48,000 citations were identified in
PubMed.gov and over 3,250,000 citations were identified in scholar.google.com. By
narrowing the search terms and adopting the sorting criteria discussed above, the search
still yielded over 15,000 citations from both sources. For the purposes of this chapter
with its focus on the current state of the literature used to discuss biobank continuity
approaches, approximately 230 articles, presentations and papers were deemed to be most
relevant. These form the basis of the literature review presented in this chapter.
34
2.2.1 History of Biobanks
Biobanks might seem to be new inventions, but, in fact, they have evolved from historical
practices dating back thousands of years. Our history as curators of the human body
extends back to some of our earliest endeavors as a species. Humans have been
practicing elaborate burials and have cared for burial sites for longer than we have been
writing, making coins, and even carving stone. The oldest known burial with deliberate
human preservation was found in Israel and is believed to be circa 14,000 years old
(Milstein, 2008). Surgical excision and preservation of human organs was commonplace
circa 3,700 years ago in the funerary practices of Egyptian Priests of Sobek. The organs
that were removed, cleaned, and dried in natron before being sealed in canopic jars where
they would accompany the mummified body into eternity. A record from the Ptolemaic
period, 2196 BCE, of a “surgeon’s” table and tools for excision can be found in Kom
Ombo, Egypt (Sullivan, 1996), where a variety of surgical instruments, used extensively
during funerary practices, were carved into the walls of the temple (Figure 1).
35
Figure 1: "Surgeon's" Temple of Sobek
Photo Credit 1: T.D. Church, Taken 2012, Kom Ombo, Egypt. The picture is from a
section of wall within the Temple of Sobek. This bas-relief of hieroglyphs date to the
Ptolemaic period of Egyptian History, roughly 2196 BCE. The carved images represent
surgical instruments found in nearby tombs with the remains of embalmers, midwives,
and surgeons. The instruments picture above, include scalpels, curettes, forceps, dilators,
scissors, and a variety of medicine bottles.
By the 3rd Century BCE, a number of papyrus scrolls existed; documenting medical
practices and rich in surgical and anatomic detail (Malomo, Idowu, & Osuagwu, 2006).
However, by the end of the 2nd Century BCE, Roman laws were put in place forbidding
dissection, autopsies, and other forms of desecration to human corpses. Those edicts
severely hindered science, leaving classical scholars like Galen to develop unique ways
to research the human body. Galen pioneered comparative anatomical and physiological
studies by using primates as a surrogate for humans (Malomo et al., 2006).
36
The fall of the Roman Empire in 419 CE initiated a drastic decline of scientific discourse
in Europe. The few medical texts that remained found sanctuary with the Turks,
Ottomans, and Persians, and were scattered among Roman Catholic monasteries
throughout Europe and North Africa (Diamond, 2005). Eventually the medical practices
of old were codified and circulated widely. Thanks in part to the writings of Avicenna,
an Islamic scholar, nearly 300 texts were translated from Arabic into Latin and Greek and
reintroduced to Europe through trade (Faruqi, 2006). These texts have been considered
by some historians and scholars to herald the Renaissance and a renewed interest in
medicine.
For much of the early and middle ages in Europe, people were reluctant to desecrate the
dead, fearing otherworldly repercussions from the spirit of the departed (Foucault, 1973;
Highet, 2005). Da Vinci’s amazing anatomical drawings were reportedly done at night –
he did not fear the dead, but was wary of the misconceptions of his countrymen (Perloff,
2013). Thus, the use of dissections to retrieve human tissues was not common practice
until the Age of Enlightenment. The enlightenment and subsequent awakening of interest
in science, mathematics, art, literature, and biology was not confined to Europe. The
rigor of the scientific method and curiosity associated with Enlightenment ideals crossed
the Atlantic during the colonization of the Americas.
2.2.1.1 Biobank History in the American Experience
Reports exist of public demonstrations of human dissection in America as far back as
1638, but the demand for cadavers began in earnest in 1745 with the first formal course
in anatomy taught at the University of Pennsylvania (Morton & Woodbury, 1835/2013).
37
In 1751, Thomas Bond and Benjamin Franklin created the first US Hospital to “care for
the sick, poor, and insane who were wandering the streets of Philadelphia”. By 1767 the
Hospital had instituted a standard curriculum in surgical training. By 1789, this
curriculum had a formalized pathology program that routinely stored excised organs in
alcohol to support the educational mission. By the end of the American Civil war in 1865
the U.S. had 178 hospitals, many of which were engaged in preserving “medical oddities”
such as tumors, tissues, and skeletons, for use in education and training of future
physicians, surgeons, and nurses (Aptowicz, 2014). Assessing the differences between
“normal” and “diseased” tissues was becoming important to understand the natural
history of disease.
The passage of the 1831 and 1832 Anatomy Acts provided the basis of modern treatment
and regulation of human bodies and, by extension, their tissues. Soon thereafter the 13th
Amendment of the United States Constitution, in 1865, made it illegal to “own” a body
deceased or alive (be it yours or that of another individual) (Wald, 2005). The goals of
these pieces of legislation were eventually operationalized by regulations and practice
guidelines to control how tissues were to be collected, stored, utilized, and accessed for
research. The legislation guided the regulation and enforcement of specimen acquisition
at the federal level, but over time, challenges arose because a patchwork of dissonant
state laws and standards were also introduced that altered requirements at a more local
level. Nearly 100 years later, in 1968, the Uniform Anatomy Gift Act (UAGA) was
passed to provide a Federal set of uniform requirements and regulations. The UAGA
ensured the right of a donor to bequeath his or her own body as a “gift to science”
38
(Skene, 2002; Wagner, 2014). It enabled anyone over 18 to donate his or her organs
upon death and established the Uniform Donor Card as a legal document facilitating
timely organ retrieval. It also identified the types and priority of individuals who could
donate a deceased person's organs.
The evolution of medical technology complicated the donation of organs as new
immunosuppressive therapies made transplants a viable reality and motivated the
unscrupulous sale of human organs. In 1984, the National Organ Transplant Act (NOTA)
was passed by Congress to establish the Organ Procurement and Transportation Network
(OPTN), a system designed to ensure that donated organs would be allocated fairly. As
part of this goal, the Scientific Registry of Transplant Recipients (SRTR) was developed
to collect long-term survival data by evaluating the status of organ transplantation donors
and recipients over time (Starr, 1998). It also provided grants to establish, expand and
assist with the operation of governmentally certified and regulated organ procurement
organizations. Such programs became particularly important as the proportion of
cadavers from unclaimed sources dwindled. Today, nearly all cadaveric tissue in the
United States are supplied by donor bequest. This spirit of volunteerism reflects dramatic
shift in public perception, from dissection as desecration, to bequest as a gift that
facilitates the continued life of others and the education of future physicians.
2.2.2 Function of Biobanks
Until recently, scientific knowledge regarding the sustenance of living cells limited
“tissue storage” largely to cadaveric tissue. Nevertheless, early forms of specialized
“biobanks” have existed for millennia (Cohen, 1999; Kierans, 2011; Titmuss, 1997). The
39
roots of milk banking, perhaps the earliest form of biobanking, reach back to times when
children were breast fed by friends, relatives or strangers - a practice referred to as "wet
nursing". Evidence for "wet nursing" is present in the Code of Hammurabi from 2250
BCE where the attributes needed for good wet nurses are described (O'Hare, Wood, &
Fiske, 2013). In those early days, children were thought to inherit the physical, mental
and emotional traits of their wet nurse through the breast milk; thus selection of the nurse
was felt to be very important. In Greece circa 950 BCE, wealthy women frequently
demanded wet nurses, because they viewed the act of breast feeding as unbecoming for
women of status. Eventually, wet nurses acquired a position of great accountability and
had authority over slaves (O'Connor & Van Esterik, 2012; Obladen, 2011). At the height
of the Roman Empire, between 300 BCE and 400 CE, written contracts were formed with
wet nurses to feed abandoned infants. The infants, usually unwanted females thrown onto
rubbish piles, were purchased by the wealthy as inexpensive slaves for future use, and the
wet nurses, many of whom were slaves themselves, fed the infants for up to 3 years.
Contracts provided a detailed account of the wet nursing service, including duration of
breastfeeding in exchange for payment in the form of clothing supplies, lamp oil, and
coin for their services (Diamond, 1999).
Wet nurses were in essence mobile biobanks who transported bioproducts directly from
donor to recipient. Clay storage vessels for human milk existed in antiquity but shelf life
was short without refrigeration and knowledge of pasteurization. It was not until 1865
when Louis Pasteur’s processes to curb the “disease of wine” were applied to milk,
effectively lengthening its storage time. Milk banking grew rapidly in the early part of
40
the twentieth century, in an effort to collect and distribute unprocessed milk to ill and
premature infants (Swanson, 2011). By 1925, Boston, New York, and Philadelphia had
milk banks that provided pasteurized milk for any infant at a reasonable cost. However,
after the great depression and subsequent Second World War in the mid-1900s, “bottle”
feeding became popular. By the early 1950s, most hospitals and health professionals
promoted artificial formula as the feeding method of choice (O'Hare et al., 2013;
Updegrove, 2013). Interestingly, however, over the last decade, certain constituents of
breast milk have been identified to be valuable for optimum development of the infant,
and have driven the renewed establishment of biobanks for donated human breast milk
(O'Hare et al., 2013).
Blood is another commodity that is banked commonly today. Its use emerged much later
in history than milk banking. Transfusions directly from donor to recipient were
attempted first in 1818 and only became commonplace by 1840 (Starr, 1998). In these
first attempts at transfusion, both donor and recipient needed to be in the same room so
that the blood could be transferred before it coagulated. By 1840, the addition of
anticoagulants and the use of a novel technology called refrigeration made it possible to
store whole blood for several days. By 1850, the first blood banks began to collect and
store blood for surgeries, post-partum hemorrhage and emergency use. However,
primitive knowledge of blood composition limited the success of blood donation because
many patients received incompatible blood. The discovery of the ABO blood groups and
the better understanding of corresponding antigens present on red blood cells did not
occur until 1900 (Titmuss, 1997).
41
Blood banks expanded in the 1930s and replaced prior “transfusion registries” by making
serum a communal resource, managed at the hospital level (Starr, 1998). By 1940, dried
plasma packets could be reconstituted in the battlefields of Europe and the South Pacific
(Waldby & Mitchell, 2006). The practice became easier in 1950 with the introduction of
plastic bags that facilitated better storage and transport. The storage of reconstituted
plasma extended its shelf life for up to 7 days at room temperature and allowed for new
markets and uses of blood products (Weir & Olick, 2004). After World War II (WWII)
hospital banks were typically replaced by regional banks and the American Red Cross
became the national blood broker. By the late 1970s, cryopreservation technologies
allowed blood products to be kept in stasis and maintain viability for up to 10 years
(Waldby & Mitchell, 2006). In mainstream United States culture, there are precedents
for payment for tissue and no cultural ban against this practice exists. While state laws
ban payment for organs for transplant, no such ban is in place for renewable tissue, such
as blood, which is one of the most commonly collected tissues procured by biobanks.
Sperm banks were the slowest to develop. Although a few such facilities appeared in the
1940s, such banks did not become a well-established public resource until the late 1980s
(Boso, 2008). These banks also typically operated more as a business than a health-care
resource; their products became commodities for sale to women who needed donor-
provided sperm to achieve pregnancy. The first successful human pregnancy using
frozen sperm was achieved in 1953. By 1957, Tyler Medical Clinic had established the
Westwood Cryobank in Los Angeles exclusively for freezing sperm. Over time,
cryoclinics developed that could collect and store sperm, extract and store ova, fertilize
42
and preserve embryos, implant embryos into the parental or surrogate womb and store
reproductive germ-line materials for up to up to 21 years (Ginsburg & Rapp, 1995). In
addition to these services, the Tyler Medical Clinic as of 2004 stored testicular tissue and
ovarian tissue (Cryobank, 2004).
Despite this long history, biobanks with the sophistication that we now expect are a
recent phenomenon that would not have been possible without two formative events in
the 1950s. First was the development of the HeLa cell, an immortalized cell line utilized
in research derived from cervical cancer cells harvested in 1951 from Henrietta Lacks,
who died of complications related to that cancer (Skloot, 2010). The ability to grow and
thus mass produce these cells marked an enormous step forward for biomedical research.
It was critical for the development of the polio vaccine; research into cancer; gene
mapping; cloning; understanding of AIDS; evaluations of exposure effects of radiation
and toxic substances; and countless other scientific advancements (Biba, 2010; Hudson &
Collins, 2013; Wagner, 2014). At the same time, it opened the market doors to the sale of
cellular bioproducts (Parry, 2008). A staggering 20 tons of HeLa cells alone are
estimated to be in circulation around the globe (Nisbet & Fahy, 2013).
Second was the discovery of DNA in 1953. The progressive understanding of the role of
DNA in programming development and modulating the production of proteins has been
seminal in guiding molecular research in such diverse fields as agriculture and law
(Collins, 2010; Dawkins, 2009; Ridley, 1999). Research into DNA has had tremendous
impact on the practice of medicine, especially in diagnosis, prognosis, and treatment of
disease (Andermann, Blancquaert, Beauchamp, & Déry, 2008). It has also changed the
43
culture of scientific research (Lim, 2014; Stokols, Hall, Taylor, & Moser, 2008; Tapscott
& Williams, 2008). To understand and manage the types of research that were necessary
to gather and map genomic materials it became untenable to work in small competitive
laboratories. Larger groups of researchers had to cooperate in order to collect large banks
of genetic information that then had to be shared. Further, when clinical information was
collected for a single specific goal, the data could later be used more broadly to support
additional research projects (O'Brien, 2009). The need to manage the huge amounts of
material and data drove initiatives to develop warehouses for community use and
efficient sharing (Desmond-Hellmann, 2012; Kauffmann & Cambon-Thomsen, 2008;
Lemke, Wolf, Herbert-Beirne, & Smith, 2010; Meir, Cohen, Mee, & Gaffney, 2014;
Mitchell & Waldby, 2010; Murphy, 2012; Newman, 2001).
The first draft of the human genome, completed by the Human Genome Project in early
2001 (Collins, 2010), was made possible by the development of more efficient
sequencing technologies that drew upon large amounts of biobank materials and other
bioinformatics resources from a large international collaboration. By 2007, genome-wide
scanning practices became much less expensive so that such methods could be used as
standard practice (Dove, Faraj, Kolker, & Özdemir, 2012). However, a lingering
problem persisted; data relevant to the genotype was easily collected directly from the
biospecimens under consideration, but the information was more difficult to link with
related phenotypic profiles. These could only be derived from other sources such as
clinical interviews, physical assessments, review of medical histories, or assessments of
environmental exposures and lifestyle habits (Artene et al., 2013; Lemke et al., 2010;
44
Mitchell & Waldby, 2010; Murphy, 2012; O'Brien, 2009). Even when such data existed,
ethical uncertainties about patient confidentiality limited the ways in which clinical and
lifestyle information could be associated with an individual’s genotypic data (AHRQ,
2015; Meir et al., 2014; Smith & Aufox, 2013; Weir & Olick, 2004). The institution of
the biobank became important as an arm’s length facility in which stored biospecimens
could be associated with genotypic and phenotypic data via an honest broker system.
Biobanks not only collect and store specimens, but serve as a library – of sorts – for
researchers wishing to work with these samples. These repositories have always had to
cope with a number of immediate challenges: ethical concerns, including informed
consent; contractual considerations; maintenance of high-quality samples through good
collection and handling techniques; difficulties when associating the donor’s sample with
clinico-pathologic information and outcomes; and concerns regarding patient privacy
throughout each step of the process. All of these concerns spawned an industry of
research to sort out the ethical, legal, and social issues: the fairness of collecting
donations from vulnerable populations; the correct manner to obtain informed consent;
the logistics of data disclosure to participants and researchers; rules around ownership of
intellectual property, and mechanisms to protect the privacy and security of donors
(Artene et al., 2013; Barbareschi et al., 2013; Cadigan, Juengst, Davis, & Henderson,
2014; Cadigan et al., 2013; Cordell, 2011; D'Abramo, 2015; Lasso, 2010; Laurie, 2011;
Widdows & Cordell, 2011). These issues are linked to the transactions that take place
when specimens like tissue, blood, or urine are gathered, brought together with other
45
associated data, moved into the repository, and moved out of it for the use of researchers.
These transactional steps are illustrated in Figure 2.
Figure 2: Biobank Transactional Process
This figure illustrates in simplified form the path taken by specimens from the point of
informed consent to specimen allocation. Each biobank may have their own practices
and procedures which would be layered into the transactional process above. Recreated
with permission (MCRC, 2016).
Initially when the samples and data are procured, subjects must be apprised about what
will be done, and not done, with the samples, through a process of education and
informed consent. The needs of the participant with respect to privacy must be managed,
46
and agreement with regard to ownership and intellectual property that might come from
the samples must be assured. Once the samples and/or data are received, the materials
must be identified in a way that assures traceability. Samples and data must be stored
under appropriate, secure conditions. Traceability must extend to the release of samples,
where again ethical issues may exist with regard to those who can receive the samples or
data and what they are able to do with them. Appropriate storage conditions must be
arranged for the samples and data. The effective operation of the biobanks through all of
these steps is made possible by an assemblage of knowledge and practice, and by the
progressive remodeling of legislation related to biobank operation (Atherton, Sexton,
Otali, Bell, & Grizzle, 2016; Birch, 2012). However, most of these activities and
capabilities have been focused on the logistics of the day-to-day sample management or
the satisfaction of regulatory requirements, such as licensing and compliance with
standards. They are complicated as well by the fact that many have required new systems
of research governance that are often not harmonized across countries or even parts of the
same country. All of these operational challenges may distract from longer-term but
important planning associated with maintaining the continuity of business operations in
boom and bust cycles of specimen utilization.
2.3 Disaster Management and Continuity Planning
Planning for crisis is almost a contradiction in terms (Boin & McConnell, 2007). How
can we plan for a phenomenon that, by its very nature, violates regular patterns and defies
planners attempting to prevent it? The lessons of disaster management and continuity
planning research maintain that political, cognitive, informational, cultural, and resource
47
challenges exist that hamper planning activities for every potential threat an organization
could face (Boin & McConnell, 2007). The very essence of continuity planning, wherein
plans are developed to work for the endless array of complex, chaotic, and destructive
scenarios that arise from interlocking and mutually dependent infrastructures, may seem
nearly impossible (Lalonde, 2011).
Biobanks are now seen as an essential asset for clinical therapeutics. However, these
contributions cannot be achieved if the biobanks do not remain operational. Like most
organizations, a proportion of biobanks will inevitably fail to deliver upon their initial
promise (Henderson, Simeon-Dubach, & Zaayenga, 2013; Schmitt, Kynast, Schirmacher,
& Herpel, 2015; Simeon-Dubach, Zaayenga, & Henderson, 2013; Vaught, Rogers,
Carolin, et al., 2011). Some biobanks will underperform, some will be forced to merge
with other biobanks, some will ultimately be forced to close, and some will inevitably fall
victim to some form of crisis.
Biobanks can face a wide variety of crises as shown in Figure 3 below. Crises relating to
infrastructure damage, personnel issues, criminal activities, financial problems or natural
disasters should be addressed within an organization’s risk management process.
Companies must confront all of these potential problems with plans and procedures
designed to guard business continuity by protecting or recovering pre-crisis operations of
key activities. This is part and parcel the focus of continuity, which as defined by
Merriam-Webster, refers to “the quality of something that does not stop or change as time
passes”. For biobanks, continuity refers to the ability to maintain biobank operations
throughout an often-complicated lifecycle of institutional change regardless of internal or
48
external perturbation. Clearly, the long-term continuity of biobanks is a key part of
running such a facility. Patients who entrust their samples to a biobank and physicians
and scientists who rely on those samples for their work depend on the long-term survival
and reliable operations of these facilities. However, such long-term continuity may be at
risk in a number of biobanks.
Figure 3: Ishikawa Diagram of Organizational Crises
The figure below was rendered by T.D. Church, utilizing the product design and quality
assurance diagram process envisioned by Kaoru Ishikawa (Ishikawa, 1968). This figure
shows crises an organization may face. This diagram is useful in identifying factors that
create or cause overall effects. Causes are grouped by major categories: physical,
personnel, external agent, natural disasters, economic, and reputational. The causes are
used to identify the sources of variation: accidents, criminal actions, floods, economic
recessions, and internet defamation.
49
Biobanks operating in the United States vary significantly. Most are decentralized, often
linked to single investigator or small disease-specific group. Further, the majority of
biobanks reside within academic medical centers with many relying on philanthropy or a
potpourri of small grants for funding, and more often than not they are understaffed.
Thus, shifts in departmental alignment, funding stream constraints, and other forms of
crisis can have profound effects on a repository. Not surprisingly, maintaining continuity
has been difficult for even some of the larger biobanks in the past, as illustrated by such
examples as the closure of the United Kingdom Human Tissue Bank in 2009, the U.S.
Armed Forces Institute of Pathology and the Singapore Biobank in 2011, and the
Massachusetts Stem Cell Bank in 2012 (Ma’n, Borry, & Howard, 2011; Stephens &
Dimond, 2015). Each of these biobanks were large, as measured by their libraries of
200,000+ samples, and served multiple disease sites and multiple research investigators.
They were funded through a mix of governmental and public dollars. Private sector
closures and mergers have also occurred. For example, the collapse of Ardais
Corporation in 2005 led it to sell its biosamples to Cytomyx Holdings and its associated
prêt-à-porter software to Gulfstream. Similarly, SeraCare Life Sciences in 2013 sold the
contents of its biobank to refocus its business on producing in vitro diagnostics (Tupasela
& Stephens, 2013; Tutton, 2007). These private sector closures do not garner much
notoriety and occur as any other business acquisition. Whereas, public sector closures
receive a lot of coverage and bring controversy over issues related to funding, politics,
and questions of ethical collection or utilization.
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The closures of repositories such as those described above raise questions about the
promissory obligations to patients and users. Closure can challenge the ability to
preserve material holdings, to treat staff responsibly and to allocate capital to manage the
infrastructure. In other businesses, plans for termination (and similar contingencies) are
typically laid out in statutory requirements, such as, provisions for corporate dissolution
(Cadigan et al., 2017). These provisions contemplate disposition of assets and property,
accounting for liabilities, and notification of provisions to parties for outstanding claims
(Ma’n, Borry, & Howard, 2011; Matzke, Fombonne, Watson, & Moore, 2016; Tierney,
2007). What these examples do not illustrate are other considerations that might be
additionally faced when dealing with the full range of potential hazards, including
relatively infrequent but catastrophic hazards, which often do not provide the facility with
the time needed to plan a graceful reorganization as might have been the case in the
situations identified above. This type of disaster management may require advance
planning, and it is this sort of advance planning that has not been subject to much
regulation or even study in the context of biobanks. Both the creation of a business plan
and a plan for termination are strongly recommended within the best practice guidelines
(ISBER, 2005/2012; NCI, 2014; OECD, 2009), and are fundamental business elements
within the financial world (Cook, 2015; Miller, Engemann, & Yage, 2015), yet they
remain mostly ignored by regulatory scholars (Cadigan et al., 2017). One best practice
document recommends, when contemplating “business risks” biobanks need to be
prepared to “provide [contributor of specimens] information that ownership could change
and explain the uncertainties associated with establishment and operation of the
[biobank]” (OECD, 2009, p. 24).
51
The study of continuity planning has had a long history within the field of organizational
management. That research to date has dealt primarily with disaster preparedness and
recovery. It has also focused on public sector organizations, such as local emergency
management agencies, fire and police department response teams, and other
governmental entities that interface with the general public in the event of a disaster.
Thus, much of the published literature appears to have a narrow focus that targets public
services rather than businesses and focuses narrowly on disaster management. Further,
many of the reported continuity studies have taken the form of single-case studies
concentrated on rare catastrophic events (e.g. Hurricane Katrina, Indonesian Tsunami,
and Fukushima Earthquake), or centered on atypical organizational problems (e.g.
Collapse of Enron) (McConnell & Drennan, 2006; Tierney, 2007). Very few specific
studies have attempted to document the potential hazard(s), risk(s), disaster(s), and
recovery experience(s) that have been specifically related to biobanks. Nevertheless,
critical risks such as disasters can cause huge, even irrecoverable damage to biobanks so
that consideration of best practices to deal with such events would seem to be important.
business processes with minimal disruption (Herbane, 2010).
2.3.1 Defining Catastrophes
The chaos and disorder that tend to follow in the wake of a natural or man-made
catastrophe have provided glimpses into what worse-case scenarios could resemble. Two
illustrative examples are Hurricane Katrina and Superstorm Sandy, both discussed in
more detail below. While these two examples highlight breakdowns in critical
infrastructure accompanied by deadly mayhem, they represent the exception, not the rule
52
(Berrebi & Ostwald, 2011). Some breakdowns remain isolated events and are quickly
remedied, others have cascading effects and are responsible for great harms (Perrow,
2007). Catastrophes exist in a sliding scale of threats that fall into one of three categories
related to key concepts of emergencies, crises, and disasters (Perrow, 2007).
Emergencies tend to be unforeseen, but predictable, narrow-scope events that occur with
some regularity (Crichton, Ramsay, & Kelly, 2009). Emergencies are fixed in time and
space as they are knowable events that follow predictable patterns; making them easy to
train and prepare for this level of event (Alexander, 2005). While emergencies can be
tragedies for those involved, the gravity of their impact is not very wide and can be
brought to closure with relative swiftness (Alexander, 2005). A good example would be
the temporary closure of a freeway due to a hazardous materials spill. Crises, on the
other hand, are of a different magnitude and disposition. A crisis represents a breakdown
in infrastructure and critical systems (Cousineau & Tranquada, 2007). A crisis
encompasses the loss of key services or the functioning of life-sustaining systems, which
require urgent attention often under conditions of deep uncertainty (Hede, 2017). The
label of disaster connotes the loss of life and severe, long-lasting damage to property and
infrastructures (Boin & McConnell, 2007). Boin and McConnell (2007) say that a
disaster, in other words, is a crisis with a bad outcome.
There is no evidence that disasters will become less frequent in the future. In fact, a
booklet from the Federal Emergency Management Agency (FEMA), designed to help
businesses identify hazards and mitigate their effects, reported a worldwide doubling in
the number of major disasters for each decade from 1990 - 2013 (FEMA, 2014). This
53
publication may portend a future of increasing global climate change with escalating
uncontrollable natural disasters. The latest iteration of the FEMA publication concludes
that the study of previous disasters and their associated responses is an important step in
building best practices and better continuity plans.
The two significant examples of disasters, discussed below, illustrate the fragility of
disaster preparedness experienced by biobank organizations, and underline further the
need for advanced planning.
2.3.1.1 Hurricane Katrina
One of the more tragic – yet instructive – examples of disaster response problems in
recent United States history relates to the damage of much of the Gulf Coast, and
particularly New Orleans, in the wake of Hurricane Katrina. Tulane University, one of
the hardest hit of the academic medical centers, witnessed a scattering of faculty, staff,
and patients to temporary areas far from home in the hectic weeks following the storm.
After the storm subsided, Tulane Cancer Center was preoccupied first with locating and
assessing the needs of their faculty and staff, in an attempt to return them to their
laboratories, classrooms, offices and clinics (Corrigan, 2008; Dalovisio, 2006; Dalton,
2005a; Winstead & Legeai, 2007). It was only after buildings were deemed safe and
access was granted to devastated lab space that the negative impact of the storm surge on
research could be appreciated fully (Dalton, 2005a; Singer, 2005; Travis, 2005). Flood
waters engulfing laboratories damaged not only research facilities, but also destroyed
irreplaceable data, tissue samples, and a variety of animals including many chimeric
hybrids central to ongoing research (Dalton, 2005b; Holtz-Eakin, 2005; Singer, 2005). In
54
addition to compromising research, damage caused by the hurricane ran the risk of
containment breeches that threatened to release infected animals and other biohazards
that could damage the environment, ground water, and public (Dickinson & Burton,
2015; Lakoff, 2008; Sklar, Richards, Shah, & Roth, 2007; Watson, Gayer, & Connolly,
2007).
An initial survey by the National Institutes of Health (NIH) suggests that Katrina affected
approximately 300 federally funded projects at New Orleans colleges and universities,
cumulatively valued at more than $150 million, including 153 projects at Tulane, Xavier,
and Louisiana State University (LSU). Among the NIH funded losses were outcome data
and samples from 25+ years of research in several longitudinal studies, including the
Bogalusa Heart Study of cardiovascular risk factors, and ongoing studies of AIDS,
cancer, and other conditions. For example, at a Tulane laboratory, cryopreserved tissue
samples collected since 1973 in the Bogalusa Heart Study thawed and became useless for
all but very minimal DNA analysis (Taylor, 2007). Many other research groups lost data
completely or found their data to be so corrupted that it was incomprehensible.
When evacuated from Louisiana State University (LSU) Children’s Hospital, researchers
were forced to leave hundreds of fragile blood and tissue samples – many, the
culmination of 20+ years of HIV and other rare blood diseases research – to an uncertain
fate. The director of the Research Institute for Children, Seth Pincus, an immunologist
whose academic career focused on studying the interaction of antibodies and pathogens,
was among a handful of researchers to share their experiences with the public.
Throughout the storm and subsequent surge, Pincus and a few hundred other hospital
55
employees remained to look after the 100 remaining patients and biological research
samples. “We probably held out the longest”, Pincus is quoted as saying. “A lot of
people in New Orleans wound up abandoning their work. I think every scientist there
was worried about what’s most important – my experiments or my life” (Travis, 2005, p.
1657).
Problems were not over even after the hurricane dissipated. Staff were forced to abandon
the hospital when clean water ran out and looters threatened their safety. They
recognized that the hundreds of research mice and transgenic rats that they had managed
to save up until this point would also be lost and faced the arduous task of euthanizing all
the research animals with pentobarbital. Together the staff managed to pack what they
could into insulated containers, hoping to keep cell lines and microbial collections
sufficiently cold until they could be transferred to a temporary facility in Baton Rouge.
“Everything I own and do is [normally] in the -80°C freezer and liquid nitrogen tanks”,
Pincus recalled (Travis, 2005, p. 1658).
In the end, many of the staff members were unable to hold out for the planned afternoon
exit convoy and struck out on foot hours ahead of schedule. In the confusion, many
important specimens were left behind or lost. Samples packed for shipment, often in
unmarked packages, were abandoned in the labs and on shipping docks (Dalton, 2005a;
Travis, 2005; Winstead & Legeai, 2007). The armed services personnel who then
occupied the building as a command center were faced with the prospect of monitoring
the generators, which eventually died. Samples in freezers that had lost power could not
be kept frozen when the backup supplies of liquid nitrogen ran out. Delays dragged on
56
from weeks into months as academic centers rebuilt facilities and began repairing
infrastructure. Each day that passed marked more loss of research samples, issues in
animal colonies, and degradation of valuable tissues (Dalton, 2005a, 2005b; Sklar et al.,
2007; Winstead & Legeai, 2007).
2.3.1.2 Superstorm Sandy
The kinds of problems seen during Hurricane Katrina were also observed on 29 October
2012, when the remnants of Superstorm Sandy made landfall along the New Jersey and
New York Atlantic coastal area. This unusual combination of weather phenomena
accompanied by tidal effects of a full moon gave rise to what has been characterized as
the most potent storm to hit the Northeast in recorded history. Its storm surge caused the
East River to rise more than 14 feet (Lurie, Manolio, Patterson, Collins, & Frieden, 2013;
McArdle, 2014; Mische & Wilkerson, 2016). New York University Langone Medical
Center (NYULMC) and affiliated hospitals – Bellevue and Manhattan Veterans
Administration – were deluged by 15 million gallons of water, flooding the first, and in
some cases the second, floor of every building on main campus in mere minutes. Soon
after the torrent began, a major power substation in the Bowery area of lower Manhattan
flooded and exploded, plunging the island below 34th Street into darkness (McArdle,
2014). NYULMC and Bellevue hospital were automatically thrown onto backup power
from onsite generators. However, backup power soon failed despite facility precautions
that included housing generators on higher floors and installing flood barriers in the
basement of buildings. The flood caused irreparable damage to medical equipment and
57
research materials and a loss of research materials, including those of the NYULMC
shared-resources research core (Mische & Wilkerson, 2016).
The losses incurred by Hurricane Katrina easily surpassed those from the costliest
hurricane previously on record and the three costliest disasters in recent history
(Hurricane Andrew, Northridge earthquake, September 2001 terrorist attacks, and Super
Storm Sandy) (Holtz-Eakin, 2005). Those expensive recovery measures were unique in
their magnitude, but not necessarily the nature of the economic consequences that any
disaster can have. Data reported by the Congressional Business Office (CBO) have
detailed the cost of some of the most recent natural and manmade disasters in American
history (CBO, 2016), summarized in Table 4 below.
Table 4: Cost of Recent United States Disasters
This report utilized insurance claim information to determine damage cost estimates for
selected US disasters in recent history. Data only represent reported claims and do not
include damages not reported and claims not filed. Compiled from CBO (CBO, 2016).
Event
Type Date
Damage
Cost
Details of Cost
Hurricane
Andrew
Natural
Category 5,
hurricane
1992 $35.8 B $19.2 B insured
• 2/3 of cost - $12.5 B homeowner
insurance
• 1/3 of cost - $6.7B commercial insurance
Northridge
Earthquake
Natural
6.7 Richter scale,
earthquake
1994 $48.7 B $18.8B insured
• 3/4 of cost - $14.8B homeowner
insurance
• 40% of all insurance claims had coverage
for earthquake damage
58
Event
Type Date
Damage
Cost
Details of Cost
Sept 11 Man Made
Terrorist Attack
2001 $87 B Losses estimated to cost:
• $35.2 B private insurance
• $11.9 B business interruption losses
• $10.4 B property loss
• $3.8 B aviation liability
• $1.4 B worker’s compensation
• $1.1 B life insurance payment
• An additional $1.1 B property loss still in
dispute
Superstorm
Sandy
Natural
Category 5-like
Hurricane
weather
2012 $42 B Losses of $42 B caused by:
• Flooding of Manhattan’s subway system
• Flooding of several tunnels
• Loss of electricity for a period of about
one week
• Network connectivity losses
• Closure of NYSE for 2 consecutive days
Even though disasters can share common themes, the planning to mitigate their damage
typically varies with the location and types of challenges most likely to present. An
earthquake in Rainbow Lake, Alberta, Canada, will present different challenges than one
occurring in the center of Los Angeles, California. Not only do differences in location
and in culture play a part in disaster management. The political, economic, legal, and
behavioral environment will affect what should and can be done in preparation (Sawalha,
Anchor, & Meaton, 2015). The best continuity plans provide flexible and locally
sensitive options as events unfold.
It is perhaps not surprising then, that no single, definitive set of regulatory guidelines can
be found to guide biobank continuity planning and management (Tierney, 2007).
Nonetheless, in some highly hazardous industries such as those related to nuclear energy
59
and chemical production facilities, regulations have been developed from which much
can be learned. For example, the Nuclear Regulatory Commission (NRC) has strict
requirements on nuclear facilities, which include regulations related to in-plant safety,
ongoing public education, and emergency planning in areas surrounding nuclear energy
plants (ONRC, 2004). Methods to manage biobank continuity are much less developed.
However, what we do know about planning for biobank continuity is examined in more
detail below.
2.3.2 Continuity
Considerations of disaster planning and recovery are frequently described using two
terms, continuity and contingency. Continuity refers to the composite processes working
in concert to achieve successful operation in light of unexpected crises (Cerullo &
Cerullo, 2004; Phelps, 2014; Sahebjamnia, Torabi, & Mansouri, 2015). Contingency
refers to the systematic development of a plan of action for those eventualities (Mische &
Wilkerson, 2016; Sahebjamnia et al., 2015). Typically, contingency planning
encompasses actions for specific crises, such as evacuation plans for personnel and
products, or plans to recover valuable equipment safely. The primary goal of
contingency planning is to restore service for critical applications (McConnell &
Drennan, 2006; Muth & Donaldson, 1998; Simeon-Dubach et al., 2013). The difference
between continuity and contingency planning seems related to business function.
Continuity typically seeks proactive solutions, whereas contingency plans enable
responses reactively.
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Continuity and contingency plans attempt to minimize potential losses by identifying,
prioritizing and safeguarding those assets that need the most protection. An established
plan with a clearly-defined course of action facilitates the most efficient and cost-
effective return of systems to production. Without a plan, the organization will face lost
motion, mistakes, and guesswork. Policy decisions which can be anticipated and made
prior to a disaster will greatly minimize confusion during the period directly following
the disaster (Ausbrooks, Barrett, & Martinez-Cosio, 2009; Das, 1999). For example, in
the case of a natural disaster, an organization’s plan should be able to define remote
locations where backup files, software, documentation, and materials are to be stored. It
should plan for outside support that can activate remote location(s) to which key business
functions can be relocated and then made to function effectively (Argote, 2013; Cerullo
& Cerullo, 2004; M. K. Henderson et al., 2013; Karakasidis, 1997; Simeon-Dubach et al.,
2013). The plan will need to consider a variety of alternative solutions to remediate the
problems – whether, for example, to repair, discard, or replace damaged data processing
equipment. Finally, a good contingency plan establishes a method for responsible
training, testing, and maintenance of the contingency plan with affected personnel in
order to assure the continued adequacy of the plan.
It is important to bear in mind that it does not take a full-blown disaster to activate a
continuity plan. Staff shortages when individuals quit, retire, or become ill can
compromise key activities. Computers may be hacked, reagent shortages may arise, or
funding may run out (Mische & Wilkerson, 2016). The continuity plan becomes a
playbook for how to operate if key staff, infrastructure, utilities, and / or materials are
61
interrupted for an extended period of time. A good balance of contingency and
continuity planning requires a close look at what is needed to recover at least the
minimum level of service and functionality required to support the research enterprise in
the face of different types of challenges that can be reasonably anticipated (Brown, 1989;
Simeon-Dubach et al., 2013).
2.4 Risk Assessment and Response
Central to planning for contingencies are activities to identify and evaluate risks. Risk
assessment can be thought of as the initial process of a risk management cycle, as that
described, for example, by the enterprise risk management standard, ISO 31000 (ISO,
2009). In this initial stage, an organization must determine the nature and extent of the
risks that it is likely to face by analyzing potential hazards and evaluating existing
conditions of vulnerability that could make those hazards a threat to its people and
property (Fiksel et al., 2014; Sawalha et al., 2015). Risk assessments will assess both the
technical features of hazards such as their location, potential severity and probability, and
also the physical, social and economic dimensions of vulnerability, taking account of the
coping capabilities of the organization that are pertinent to the risk scenarios (Cook,
2015; Simeon-Dubach et al., 2013). Identifying the relative magnitude and likelihood of
risks created from threats to technology, information, and people is crucial to planning
effective continuity processes (Cook, 2015; Fiksel et al., 2014).
Risk evaluation follows the risk analysis phase. It relates the risks that have been
identified to the risk appetite of the organization. Risks then must be controlled,
preferably by preventing or deterring potentially undesirable events or by mitigating them
62
in some way. Effective controls to mitigate risks form an integral part of continuity
planning. Some examples of controls are the protection of physical and computerized
systems through such approaches as surge and virus protection, firewalls and encryption
for information systems; physical security for critical records; fire alarms, sprinkler
systems and fire safety training for personnel; storm hardening, seismic upgrades and
flood alarms; and low battery alarms on freezers and other critical equipment (Auray-
Blais & Patenaude, 2006; Simeon-Dubach et al., 2013; Tierney, 2007). However, they
also can include other types of mitigations if the nature of the threat differs. For example,
controls might include awareness and de-escalation training for personnel to mitigate the
potential for workplace violence and physical security measures such as badges and
entrance control procedures to restrict the entry of individuals who might cause problems.
Once controls have been put into place, a monitoring phase completes the risk
management cycle. In this phase, the effectiveness of the risk controls is monitored in
order to detect events that may have been underestimated or badly managed. Together all
of these steps allow for a comprehensive view of the risks so that managers can make
more informed decisions about how to manage risk portfolios (Fiksel et al., 2014;
Mitchell & Waldby, 2010; Sawalha et al., 2015; Simeon-Dubach et al., 2013). The risk
management process then becomes integral to the system for business continuity
management. A key lesson from much of the risk management literature is that hazard
reduction in the face of change is a continuous and iterative process, as shown in Figure 4
(Klein et al., 2003).
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Figure 4: Iterative Model for Hazard Risk Reduction
Recreated with permission (Klein et al., 2003) to show the cyclical and iterative nature of
risk reduction modeling. This model has a modeling component at its core, indicating
enhancements that can be incorporated at any step of the process.
Although business continuity management can help organizations to avoid disruptions or
resume a relatively normal operational state after a disruption has occurred, traditional
approaches also can have serious limitations. Some analysts have suggested that most
business continuity plans rely too heavily on risk identification (Cerullo & Cerullo, 2004;
Phelps, 2014). In a complex network, organizations will face many risks that cannot be
predicted or characterized before they happen (Comfort, Sungu, Johnson, & Dunn, 2001).
These “emergent risks” often arise due to improbable events whose causes are not fully
understood, and their potential cascading effects are hard to model in advance.
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Further, many plans appear to place undue weight on statistical information, even when
the information on which the statistics are based is insufficient to guide critical decision
making (Marko-Varga et al., 2014; Sahebjamnia et al., 2015). Risk assessments are
limited by the quality and credibility of the assumptions upon which they are based;
faulty assumptions or data can lead to misallocation of resources (Simeon-Dubach et al.,
2013). Particular challenges arise for events considered to be low-probability, high-
consequence disasters for which there is little empirical knowledge or local experience
(de Bélizal, Lavigne, & Grancher, 2011). Managers and decision-makers may
underestimate the probabilities of these events or the magnitudes of the consequences of
their decisions.
A third limitation is related to the reductionist approach that often is typical of risk
identification, assessment, mitigation, and monitoring. Built into this type of analysis is
the tendency to identify and evaluate each potential risk individually (Smith & Aufox,
2013). Hidden interactions between or among risks are seldom recognized. The
complex, dynamic interactions that often happen when one disaster cascades into another
are not easily captured, and will require a response that is both flexible and agile (Paton
& Johnston, 2001; Tierney, 2007).
Finally, traditional risk management is typically predicated on the goal of returning the
organization to its original operating state. In this view, disruptions are seen to perturb
the system from this “stable” state. However, some have argued that a return to a
previous state may not be the best outcome. Every disruption represents a learning
opportunity that might help to shift the organization to a different, perhaps more
65
successful, state of operation (Atherton et al., 2016; Mische & Wilkerson, 2016; Simeon-
Dubach et al., 2013; Whitworth, 2006). Over time, an organization can begin to identify
latent opportunities in their risk landscape, and can exploit these insights to improve the
organization’s resilience.
A way to circumvent some of the limitations listed above is to consider a portfolio
approach in which a number of varying risks are examined in tandem as well as
individually (Berger & Missong, 2014; Paquin, Tessier, & Gauthier, 2015). This type of
approach seeks to mitigate the composite and cumulative risks across the ecology of the
organization (Walker et al., 2002). The portfolio approach revises the view of risks as a
set of unambiguous, independent challenges by encouraging novel solutions based on
prior experiences with the types of interactions that have occurred elsewhere, and can aid
decision-making in the face of a full-blown disaster. It also helps to avoid “risk
blindness” (Fiksel et al., 2014), often associated with a narrow focus on a small number
of particular scenarios, or of “risk drift”, when a risk grows in frequency or severity over
time as processes change or internal or external forces on the ecosystem become stronger.
A portfolio approach is seen to be more dynamic in that it can be applied to particular
types of problems as they appear or escalate (Simeon-Dubach et al., 2013).
2.4.1 Resilience and Sustainability
In 2002, the Secretary General of the United Nations, Kofi Annan, stated, “we can, and
must build a world of resilient communities and nations” (Berz et al., 2002). Annan’s
comment is found in the forward of the United Nations International Strategy for Disaster
Reduction (UNISDR) that supported the need for a paradigm shift in how disaster
66
management is envisioned and deployed. The initiative posits that humankind has
entered a period of new and increased risk from disaster due to climate change,
increasing population, rapid urbanization, deforestation, and depletion of ocean life.
Resilience in the context of disaster management is the capacity of a system, community
or society to resist or to change in order to obtain an acceptable level of function. It is
determined by the degree to which the social system is capable of organizing itself to
increase its capacity for learning and adaptation, including the capacity to recover from a
disaster (Fiksel et al., 2014; Kahan, Allen, George, & Thompson, 2009; O'Sullivan,
Kuziemsky, Toal-Sullivan, & Corneil, 2013; Sahebjamnia et al., 2015; Sawalha et al.,
2015). This process of resilience is thought to be made possible by constituent agents
interconnected through a network of linkages that interact nonlinearly as behaviors
evolve (Ikegami, 2000; Saunders, 2014). The emergent activities can be reinforced by
feedback that can alter or reinforce those cause-effect relationships (Forget & Lebel,
2001; McLeroy, Bibeau, Steckler, & Glanz, 1988; Ross, Eyles, Cole, & Iannantuono,
1997; Star, 1999), and thus result in evolutionary self-organizing responses (Gulati,
Sytch, & Tatarynowicz, 2012; Herbane, 2010; John, 2003). When the complexity of the
environment increases, for example, through a disruptive event, the performance of the
system may decrease because the system is unable to process the depth and breadth of
information needed to coordinate all the components of the system effectively. The
ecosystem must balance between preparedness and resilience if it is to cope adequately
with the disruption (Berz et al., 2002; Cook, 2015; Dickinson & Burton, 2015; Fiksel et
al., 2014). For organizations like biobanks, these adjustments can require
67
transformations at several levels as suggested in Figure 5 (Fiksel et al., 2014; Herrfahrdt-
Pähle & Pahl-Wostl, 2012; Walker et al., 2002).
Figure 5: Biobank Resilience Adaptive Model
Adaptive capacity outcomes are illustrated post exposure to a disruptive event.
Resilience begins at the organization level where the components of organizational
resources interact. A shock activates different organizational components in order to
stabilize. How organizations react through their adaptive capacity determines future
functionality form a return to operation, recover over time, or collapse. Modified and
recreated with permission (DFID 2011).
When disturbances occur, adaptive resilience tends to manifest as one of three types of
organizational change: persistence, adaptation, and transformation (Figure 6). A
“persistent” response is one that results in incremental adjustments, often at the level of
operational rules or best practices, to reestablish continuity. Such changes can take place
within the current framework of business operations without questioning the fundamental
assumptions that inform those operations. One example of such a change for a biobank
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would be better management of ambient internal temperatures by controlling more
effectively the freeze-thaw cycles to which specimens can be exposed as samples are
taken from a -80°C freezer. This could be accomplished by switching from a manual
tissue retrieval process during which a large freezer door must be opened to an automated
system in which a robotic arm retrieves a single, requested sample, which moves through
an “airlock” like system to maintain ambient freezer temperature more effectively. Such
a change could be made without knowing if the robotic solution would have other
consequences that might be hard to manage in the face of certain kinds of challenge.
Figure 6: Model of Adaptive Resilience
This figure shows the impacts of continuity or change on organizational functionality.
The gradients between continuity and change show the adaptive resilience technique
needed to return an organization to equilibrium. Recreated with permission from (Fiksel,
Polybiou, Croton & Tettit, 2014).
69
An “adaptive” change is a deeper change in which assumptions are reviewed, though
often without probing underlying contextual issues (Gunderson, 2000; Olsson et al.,
2006). One example of such a change would be to introduce a new process in which
specimens are frozen in “cryo-straws” that are more challenging than traditional Pyrex or
acrylic aliquot vials to use. These cryostraws, due to their smaller size and increased
packaging of straws per rack, increase storage capacity and provide a way to reduce
sample loss when power outages occur (Baker, 2012). The straws closest to the middle
will retain their temperature, while those on the periphery of the bundle will face more
fluctuation in temperature and potential thawing. An adaptive strategy in this case would
be to spread aliquoted straws from one individual across multiple bundles and vary the
bundle location (some interior, some exterior).
More demanding even still are the changes that often must be made when faced with a
mismatch between the function of the biobank and a modified environment that requires
the organization to “transform” in order to remain viable (Olsson et al., 2006).
“Transformation” describes an organization’s ability to recreate itself into a
fundamentally new system (Gunderson, 2000). When a social-ecological system has
been challenged by an undesirable managerial regime, transformation can establish new
leadership and reset the culture (Collins, 2001; Torres & Marshall, 2015). It implies a
learning process in which the basic tenets of a prevalent model of operation are examined
and the results of this investigation drive changes to a new, better model.
Transformations could be associated, for example, with changes in constitutional rules, or
the incorporation of new laws and procedures. An example of transformation might be a
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situation in which a biobank is consolidated from a series of unconnected small banks to
a centrally administrated research core in response to a need to maximize the use of
restricted funds or a change in the administration of an academic medical center.
2.5 Historical Context Informing Guidance in the United States
Systematic plans for contingencies are hard to develop and implement. Thus, a useful
first step would be to look for frameworks that might guide the organization in these
planning exercises. Such formalized approaches to continuity planning were to some
extent available even before biobanks themselves were developed. They appear in the
United States to take origin from cold war fears of nuclear holocaust which dominated
discourse in the late 1950s and early 1960s (Boyer, 1994; Farrell & Goodnight, 1981;
Jacobs, 2010). It was during the “Atomic Age” that a systematic method for dealing with
potential crises began to emerge specifically in the arena of civil defense. Later in the
1960s, crisis management expanded to a more general form of “all hazards” preparedness
to deal with a broader range of potentially catastrophic threats (Jacobs, 2010; Lakoff,
2008). Over the following two decades these initiatives were directed at many different
scenarios such as threats from catastrophic disease, bioterrorism, and unintended release
of biological specimens from research labs (Anderson & Bokor, 2012; Barras & Greub,
2014; Molina & Earn, 2015). What began to emerge was a search for a common set of
methods that could be employed to prepare for a spectrum of crises in advance. Crises,
no matter how diverse, were seen to share a certain number of common elements: a
paucity of accurate information; difficulty of communication among decision makers;
and a confusing array of authorities seeking to manage the situation. These early plans
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made flexibility for decision makers heavily reliant on the extent to which the crisis
planning manager had been able to forecast and prepare for the situation (McConnell &
Drennan, 2006).
2.5.1 Legislation Related to Continuity Planning
During the 1970s two influential but seemingly unrelated pieces of legislation were
enacted that would come to be cornerstones of modern continuity regulations. The first
was the Flood Disaster Protection Act (FDPA) of 1973, responsible for developing a
national flood insurance program and establishing disaster recover planning as an
organizational requirement (FEMA, 1968/1973/1997; Myers, 1976). The second, the
United States Foreign Corrupt Practices Act (FCPA) in 1977, triggered a series of
economic and political drivers that eventually required business continuity management
as an organizational objective (Smallwood, 1978), to assure that documented
arrangements were in place to protect vital company records from destruction (Herbane,
2010). The FCPA differed from that of the Flood Disaster Protection Act by
acknowledging that human error or deliberate malice rather than random technical or
mechanical failures could be a cause of risk that might trigger organizational crisis.
Together these early pieces of legislation heralded a shift in the collective thinking about
disasters, that human actions as well as technically- or environmentally-related problems
could cause a disaster (McConnell & Drennan, 2006; Sawalha et al., 2015).
Specific requirements for continuity planning in different sectors began to appear in the
1980s. In 1983, the Office of Comptroller of the Currency issued Banking Circular BC-
177, which obliged all United States banks to have formal continuity and disaster
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recovery plans with provisions and testing procedures for off-site data backup and
security (OCC, 1983). Subsequent revision of the BC-177 in 1987 extended the scope of
contingency planning and disaster recovery activities into broader operational areas such
as service bureaus and / or outsourcing companies (OCC, 1997). The U.S. Expedited
Funds Availability Act (1989) set down the legal requirement for federally chartered
financial institutions to ensure next-day availability of deposits and required a business
continuity plan to be in place to assure this guarantee (USC, 1989). With the
monumental Financial Services Modernization Act of 1999, financial institutions were
required:
(1) to insure the security and confidentiality of customer records and information;
(2) to protect against any anticipated threats or hazards to the security or
integrity of such records; and (3) to protect against unauthorized access to or use
of such records or information which could result in substantial harm or
inconvenience to any customer (USC, 1989, p. 101)
Sector-specific legislation requiring organizations to introduce measures to protect vital
resources and recover activities in the event of a serious operational interruption was
soon not confined to the financial services sector. The Health Insurance Portability and
Accountability Act (HIPAA) and Telecommunications Act, both enacted in 1996,
extended disaster management requirements to the healthcare and telecommunications
sectors respectively in order to ensure the availability of systems and the security of
customer records (DHHS, 2013; FCC, 1996). The continuity of critical infrastructure and
operations managed by the U.S. government was also highlighted by the publication of
Executive Order 12656 in 1988 which created an obligation that the head of each federal
department and agency shall ensure the continuity of essential functions in any national
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security emergency by providing for: succession to office and emergency delegation of
authority in accordance with applicable law; safekeeping of essential resources, facilities,
and records; and establishment of emergency-operation capabilities (EO, 1988).
This Presidential Executive Order influenced the 1993 Office of the Management and
Budget (OMB) Circular A-130 that specified the need for an incident response capability,
continuity of support, and contingency planning within a system security plan designed to
augment the security of federal resources (OMB, 1993). Shortly thereafter, Presidential
Decision Directive 63 set out to ensure a mechanism for the continuity and operability of
essential public services, such as telecommunications, energy, banking and finance,
transportation, water systems and emergency services (NTIA, 1998). Interestingly,
Presidential Decision Directive 67 saw the first formal requirement for a continuity-of-
operations plan, as envisioned through a continuity-of-government-operations framework
(PDD, 1998).
Of course, none of the planning exercises outlined above could predict the events of
September 11, 2001 as the orchestrated attacks in New York, Pennsylvania, and
Washington, DC unfolded. The magnitude of this crisis rippled across many sectors of
American public and private lives. The crisis was amplified by the combination of mass
casualties and fatalities, lost access to civic buildings, closure of mass transit, and loss of
telecommunication connectivity. American business and organizations saw their
capabilities eroded through lost facilities, suppliers, and clients (McConnell & Drennan,
2006). The tragic events of 9/11 forced a critical introspection of business continuity
planning and disaster management and the consequent introduction of legislation,
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guidelines, and regulations related to financial services, public authorities, emergency
services, stock exchanges, and utilities (Berrebi & Ostwald, 2011; Dresser, 2012). The
following table (Table 5) highlights the most germane pieces of legislation and associated
statutory instruments. Intrinsic to each of the documents listed below (Table 5), are the
underlying requirements that organizations build, test, and maintain a business continuity
plan that incorporates a disaster recovery process. These documents delineate areas that
require safeguards, typically related to commerce, technology, and personal information.
Table 5: Post-9/11 Guidelines and Regulations Landscape
Recreated with permission from (Herbane, 2010). This table summarizes key guidances
and their significance to continuity, disaster planning, and recovery, shown by year and
government office issuing the guidance in the post 9/11 reactive landscape.
Year
Government
Office
Guideline,
Regulation,
Standard
Significance
2002 Department of
Homeland Security
U.S. Homeland
Security Act,
Continuity planning
and resource
allocation
Clearly outlines reporting structure and
decision making processes;
specifically, as related to resource
utilization.
2002 Federal Reserve
Board,
Office of
Comptroller of
Currency,
Securities
Exchange
Commission
FRB-OCC-SEC
Guidelines for
strengthening the
resilience of U.S.
financial system
Three business continuity objectives
have special importance for all
financial firms and the U.S. financial
system as a whole:
Rapid recovery and timely resumption
of critical operations following a wide-
scale disruption;
Rapid recovery and timely resumption
of critical operations following the loss
or inaccessibility of staff in at least one
major operating location; and
A high level of confidence, through
ongoing use or robust testing, that
critical internal and external continuity
arrangements are effective and
compatible.
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Year
Government
Office
Guideline,
Regulation,
Standard
Significance
2002 National Institute
of Standards and
Technology,
North American
Electric Reliability
Council
Special Publication
800 Series Security
guidelines for the
electricity sector
Reduces the likelihood of prolonged
interruptions and enhances prompt
resumption of operations when
interruptions occur. Consider flexible
plans that address key areas such as
telecommunications, information
technology, customer service centers,
facilities security, operations,
generation, power delivery, customer
remittance and payroll processes. It is
useful to revise and test plans on a
regular basis. It also is advisable to
train personnel so they fully
understand their roles with respect to
the plans
2002 National
Association of
Securities Dealers,
Securities and
Exchange
Commission,
Federal Financial
Institutions
Examination
Council
Rules 3510 / 3520
and New York Stock
Exchange Rule 466
Business continuity
planning booklet
Requires a business continuity plan
with, at minimum, the following
elements: data back-up and recovery;
mission critical systems; financial and
operational assessments; Alternate
communication plans for customers
and firm; firm and employees;
business constituent; reporting and
communication with regulators.
Further, a test must be conducted
yearly and recommendations for
modifications related to operations,
structure, business, or location must be
documented.
2003 Federal Financial
Institutions
Examination
Council,
National Futures
Association
Compliance Rule 2-
38 Business
continuity planning
Establish and maintain a written
business continuity and disaster
recovery plan that outlies procedures
to be followed in the event of an
emergency or significant business
disruption. The plan shall be
reasonably designed to enable the
Member to continue operating, to
reestablish operations, or to transfer its
business to another organizations as
needed.
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2.5.2 Laws More Specific to Biobank Continuity
Over the last decade, the scale of the biobanking enterprise has become much larger than
most would guess. By 2008 researchers in the United States stored an estimated 270
million specimens in biobanks, and new samples were being collected at a rate of about
20 million per year (Henderson et al., 2013; Horn, Bialick, & Terry, 2010; Hoyer, 2012;
Mitchell & Waldby, 2010; Piehl, 2011). Many have progressed beyond single-center
research centers to sophisticated collaborative consortia where resources are pooled to
guard highly aggregated samples and data critical to discovery and drug development.
One area of particular importance is that of cancer research. At the State of the Union
address in 2015, President Obama announced the precision medicine initiative
necessitating the establishment of a new, national-level biobank with the aim of enrolling
1 million American participants (Master, 2015). In January 2016, the United States
issued a call to arms in the publication of an interagency memorandum entitled, White
House Cancer Moonshot Task Force, which states: “today, cancer research is on the cusp
of major breakthroughs” (Obama, 2016). While not directly stated, the directive alludes
to the development of consortia, pooling of data, and use of materials and specimens
housed within biobanks as a way of fulfilling the Cancer Moonshot initiatives.
Despite its impressive expansion as a critical resource, legislation and guidance for the
continuity of biobanks is in an underdeveloped state. Almost none of the laws discussed
above relate specifically to biobanking, and the law that exists is focused on a rather
small part of the overall set of contingencies that would be covered by a systematic plan.
Biobank best practice documents acknowledge the need for biobanks to address
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management and operations issues related to continuity planning, yet they discuss no
specific strategies for implementation (ISBER, 2005/2012; NCI, 2014; OECD, 2009).
Perhaps the most relevant bit of legislation is HIPAA, discussed briefly above, which
regulates the use of data and private information related to post-surgical or post-
interventional materials and their disposition (DHHS, 2013; Vaught, Rogers, Myers, et
al., 2011). HIPAA provides legal protection for patients’ identifiable health information
that is typically associated with the biospecimens in a biobank (Scott, Caulfield, Borgelt,
& Illes, 2012). It requires that the organizations have a contingency plan, outlined in
§164.308(a)(7)(i), to ensure that data is protected during emergencies in order for an
organization to be considered compliant (DHHS, 2013; Sittig, Gonzalez, & Singh, 2014).
The required plan would include criticality analyses of computerized applications and
data, a robust data backup plan, a disaster recovery plan, an emergency-mode operation
plan, and testing and revision procedures. In the final version, the HIPAA working group
made explicit the implementation specifications for testing and revision procedures, but
provided little guidance on other aspects.
Just as HIPAA focused on the preservation of private information, the Presidential
Directive 5, issued in 2003, focused on preparedness for pandemics. It is to some small
extent relevant to academic biobanks because it requires colleges and universities seeking
federal funding for preparedness activities to adopt the National Incident Management
System (NIMS) based approaches and strategies specified by the FEMA (EO, 2003). A
similarly focused piece of recent legislation was the Pandemic and All Hazards
Preparedness Act of 2006, revised in 2013, that called for planning to address public-
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health concerns related to pandemics and bioterrorism (DHHS, 2006/2013). This Act
included a range of measures that included the restructuring of the Food and Drug
Administration (FDA), provision of funding for local and state health agencies, training
programs for epidemiologic investigators, and a novel biomedical research initiative. As
its central goal, this Act sought to create an integrated system of preparedness, one that
extended from pathogen detection to vaccine production to the relations among the
government agencies that would be responsible to coordinate actions during a hazardous
event. Because samples from biobanks are often important in research activities related to
bioterrorism agents, they would be touched, albeit quite peripherally, by these rules and
activities.
2.5.3 Standards and Guidance Documents Specific to Biobank Continuity
Additional sources of guidance that can also be consulted for continuity planning are the
documents that regulatory and standards-setting agencies develop for various purposes.
However, the regulations, guidelines, and operational standards related to biobanking are
for the most part mute on the issue of biobank continuity management. Perhaps the most
appropriate references on this topic for biobanks today are those of the National Cancer
Institute (NCI) [specifically Best Practices for Biospecimen Resources (OBBR, 2011)]
and standards of the International Organization for Standardization [specifically ISO
22301:2012,(ISO, 2012)] that are increasingly cited when procedural documents are
written by US academic medical centers (Barbareschi et al., 2013; Burris, 2008; Dabrock,
Taupitz, & Ried, 2012; Gottweis & Lauss, 2012; G. E. Henderson et al., 2013; Laurie,
2011; Lenk, Sándor, & Gordijn, 2011). Even these, however, discuss disaster or
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contingency planning in a superficial way, as part of text on general management (e.g. “a
continuity or legacy plan should be in place”) or with reference to only certain specific
areas of logistics (e.g. “backup data should be stored in an offsite location”) (Webb,
Tierney, & Dahlhamer, 2000).
2.5.4 NCI Best Practices
In 2014, the National Cancer Institute (NCI) published the Biobanks and Biospecimen
Research Branch (BBRB) Best Practices document to outline the technical, operational,
legal, and policy obligations required to enable a consistent level of standardization
across biospecimen resources (BBRB, 2014/2016; OBBR, 2011). A portion of that
document, Section C.1, Principles for Responsible Custodianship, discusses the
caretaking responsibilities for biospecimens from collection through utilization, and its
subsection, C.1.2 Legacy or Contingency Plans, outlines six areas that should be part of
an overall management plan for to manage the continuity issues related to biobanks
(BBRB, 2014/2016). The types of problems that it identifies are those associated with
one or more of the following challenges:
1. End of the budget period of the grant,
2. loss of management or termination of funding,
3. accomplishment of the specific research objectives of the study,
4. depletion of biospecimens,
5. achievement of critical data end points, and/or
6. discontinuation of participation by human research participants
(BBRB, 2014/2016, p. 32-33)
In the event of a foreseeable termination, the research team is recommended to consider
1) the continued value for research; 2) the capacity for financial self-sustainability; and 3)
the ability to transfer contents to a suitable research facility, when making its decision to
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close the facility. Its recommendations are voluntary. Further, it is not necessary to
implement the entire tool; parts can be adopted as needed. Notably, it does not discuss
custodianship during unexpected events such as disasters.
2.5.5 ISO Standards
The International Organization for Standards (ISO) is an independent, non-governmental
organization with members from 164 participating countries (Jasmontaite, Delprato,
Jager, & Neubauer, 2015). Since its founding in 1947, ISO has authored nearly twenty
thousand standards covering diverse topics from manufactured products and technology
to food safety, agriculture and healthcare (Vaught, Kelly, & Hewitt, 2009). Its standards
are seen to foster products and services that are safe, reliable, and of consistently good
quality, from efficient, capable manufacturing environments. They additionally help to
promote global trade, by establishing best practices for goods, services, and products at
the global level and ensuring that certified products conform to the minimum standards
set internationally. Their standards do not address biobanking specifically. However, its
business management series ISO 22300 and more specifically its subcomponents, ISO
22301:2012 “Societal security – Business continuity management systems –
requirements”, offer more general guidance on how organizations can conduct business
through socially responsible behaviors by acting in ethical and transparent ways that
contribute to the health and welfare of society (ISO, 2012).
This international standard is applicable to all types and sizes of organizations
that wish to
a) Establish, implement, maintain, and improve business continuity
management systems (BCMS),
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b) Ensure conformity with stated business continuity policy,
c) Demonstrate conformity to others, …
…this international standard can be used to assess an organization’s ability to
meet its own continuity needs and obligations (ISO, 2012, p.10)
Although ISO 22301:2012 lays out general areas to be considered when planning for
continuity, the extent to which it should be followed depends on the organization's
operating environment, complexity, and embeddedness in parent organizations. As stated
in the standard,
…business continuity contributes to a more resilient society. The wider
community and the impact of the organization's environment on the organization
and therefore other organizations may need to be involved in the recovery process
(ISO, 2012, p. 1).
Importantly, this and other standards typically cannot be enforced. Unless they are
referenced in laws or regulations, it is not possible to hold organizations accountable for
non-compliance. Conformity with the standard can however, be secured through
registration and certification through an accredited third party. Alternatively,
organizations can “make a self-determination and self-declaration of conformity” (ISO,
2012).
The two documents discussed above represent different approaches to continuity
assurance. The ISO standard espouses an adaptive approach to build resilience and
promote recovery. The BBRB best practices document guides the reader by stressing the
importance of protecting the business property and taking steps to reduce direct loss after
a disruptive event has occurred (Tierney, 2007). However, neither is detailed in its
advice regarding the specifics of preparedness for a disaster response, such as how
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exactly to cope with the months and perhaps years of disaster-induced community and /
or institutional disruption that can follow a disaster (Tierney, 2007).
A few attempts to establish disaster planning in particular biobanking organizations have
also been documented in a way that can be accessed publicly. For example, the United
Kingdom Biobank and the Icelandic Heritage Genetics bank (deCODE) have documents
that discuss certain specific risks, such as the problems of losing information in
computerized systems or coping with physical hazards such as flooding, fire, and wind
damage (Baker, 2012; Haradttir, 2002; Winickoff & Winickoff, 2003). These shorter,
site- or topic-specific documents have the advantage that they can be read more quickly
and implemented more easily, but they provide only part of what must be in place when
designing a more comprehensive plan designed for a range of disasters that might occur
in different places and local organizations (Engwall, 2003; Marko-Varga et al., 2014;
Mitchell & Waldby, 2010).
2.6 Additional Guidelines from International Sources
The international regulatory environment is highly influenced by activities relating to
continuity management in the United States. Few stand-alone documents from other
constituencies appear to have added unexpected or broader insights to the continuity
discussion. Rather, most of them work with or expand upon the legislation put forth by
the United States (Jasmontaite et al., 2015; Simeon-Dubach et al., 2013). A detailed
analysis of literature in all of the countries of the world is beyond the scope for this
dissertation. Most likely to inform or add to the US literature have been a small number
of standards that appear to have undergone revision or modification activities, and then
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became foundational as new international standards were subsequently developed. A
good example of this type of guidance is the British Standard, 7799 Information Security
Management (BSI, 1995/2005) that after three revisions evolved into ISO 17799
Information Security Management (ISO, 2005) and additionally appeared to contribute to
ISO 27002 Information Security Controls (ISO, 2005/2013). Each iteration of this
standard features business continuity management as an important element, albeit
restricted to guidelines for organizational information security standards and management
practices including the selection, implementation and management of controls.
The Australian and New Zealand AS/NZS 4360:2004 Risk Management Standard
(AS/NZ, 1995/2004) has become a popular risk management methodology internationally
because it is easily adapted to many types of organizations. AS/NZS 4360 underwent
three revisions and in 2004 was replaced by ISO 31000 Risk Management (ISO, 2009),
described above, as the international standard for risk management. Although the initial
standard AS/NZS 4630 was primarily based on the risk management process itself, ISO
31000 was expanded to describe not only the risk management process itself, but the way
that the management system should support the design, implementation, maintenance,
and ongoing improvement of that process. Further, AS/NZS 4360:2004, like most risk
management documents, appeared to focus primarily on risks to patient safety, whereas
the broader elements within ISO 31000 identify risks to economic performance and
professional reputation as well.
An integrated international approach to continuity management and disaster planning
would seem to be increasingly important in modern commerce. This general concern was
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clearly central to thinking when The Hyogo Framework for Action (HFA) was generated
by the United Nations to explain the work required from all different sectors and actors to
reduce disaster losses. The HFA was a ten-year initiative spanning from 2005-2015 with
the goal of building the resilience of nations and communities to disasters. It has been
called the first comprehensive plan intended to explain, describe, and detail the work
required from different sectors and actors to reduce disaster losses. HFA outlined five
priorities for action and offered guiding principles with practical means for achieving
disaster resilience. These were:
1. Prioritizing hazard risk reduction by providing high-profile leadership,
establishing relevant policies and programs, and allocating resources to
implement them
2. Identifying, assessing and monitoring disaster risks and improving early
warning systems
3. Creating awareness at all levels of society about risk and providing
information about how to reduce it
4. Reducing social, economic, and environmental vulnerabilities and those
related to land use through improved development planning and post-disaster
reconstruction by all sectors
5. Strengthening disaster preparedness for effective response at all levels
(UNISDR, 2005, p. 6)
However, apart from the guidance provided rather generally in certain ISO documents,
rather little has been available to guide disaster planning in biobanks that is harmonized
at an international level. Thus, as biobanks have begun to transition from small local
collections to large international consortia, several international organizations have begun
to publish their “best practices”. The International Society for Biological and
Environmental Repositories (ISBER) was the first organization to provide such
documentation in 2005, and their “best practices” document has undergone two revisions,
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the latest, in 2012 (ISBER, 2005/2012). The goal of the ISBER “best practices” is aimed
at promoting the availability of high-quality biological and environmental specimens for
research endeavors. The documents are particularly ambitious in their focus on evidence-
based and consensus-based practices for collection, long-term storage, retrieval and
distribution of specimens, but to date say relatively little that is specific regarding
continuity management.
2.7 Synthesis of Literature Review
The review of continuity planning and disaster management related to biobanks does not
identify a comprehensive way to approach continuity planning. Most regulations and
guidance focus on one or two practices such as computer systems management or
document security. Thus, we do not know whether and how most biobanks are dealing
with continuity planning and program implementation. We further do not know when
such planning is undertaken, where the planners go for their guidance, and whether they
feel that additional biobank specific guidance would be useful.
To gain a better understanding of biobank continuity practices, it seems important to
probe the planning and implementation activities of biobanks directly from the
individuals who are in positions of responsibility. This type of focus fits with the
definition of implementation by Fixsen and colleagues as “a specified set of activities
designed to put into practice an activity or program of known dimensions” (Ogden &
Fixsen, 2015). It differentiates a program from its subordinate practices that can be
considered as simple procedures which are adopted individually for use by individuals
(Ogden & Fixsen, 2015).
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Fixsen and his colleagues (Bertram, Blase, & Fixsen, 2015) have provided a well-
recognized framework by which implementation activities can be systematically
characterized and studied. The development and implementation of practices and
programs is modeled as a cascading series of steps (Figure 7). In the Fixsen model, the
process of implementation progresses through four key stages, identified as: 1)
exploration (sometimes referred to as adoption); 2) installation; 3) initial implementation;
4) full implementation (Blase & Fixsen, 2013; Fixsen et al., 2009). The starting point to
a thoughtful implementation strategy includes the “exploration” of practices that need to
be developed or modified. The second stage is one in which changes are “installed”, by
seeking the resources and arranging the training needed to implement that program. The
third stage, “initial implementation”, is when the nascent program is introduced and to
some extent exercised, and where weaknesses or mismatches with the organization are
identified. Finally, “full implementation” is considered to be the stage at which the
program begins to be evaluated and monitored, and at which ongoing attention is paid to
updating the program in light of environmental changes. These stages are understood to
have recursive elements that interact in dynamic ways as practices, programs, and context
are introduced. As indicated by Ogden and Fixsen (2015) implementation unfolds in “an
environment full of personnel rules, social stressors, union stewards, anxious
administrators, political pressures, interprofessional rivalry, staff turnover, and diamond-
hard inertia”. The process of implementation does not happen quickly. Depending upon
the complexity of the innovation the process could take years, especially if it is to be
remodeled to create an effective and sustainable program. Without periodic adjustments
to practices, implementation may prove inefficient, and programs become unsustainable.
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Figure 7: Stages of Implementation Framework
Recreated with permission from (Fixsen et al., 2009). The four stages of the model
include the major benchmarks undertaken to get a program or practice designed,
developed, tested, and implemented.
Fixsen and colleagues see effective implementation to depend on a number of
implementation drivers (Figure 8), that also can be modeled and can help to understand
the forces that affect implementation (Bertram, Blase, & Fixsen, 2015). The key drivers
are grouped into three principal areas related to competency, organization and leadership.
Competency drivers cultivate the competence and confidence of practitioners by focusing
on staff selection, training, coaching, and performance assessment (Bertram, Blase, &
Fixsen, 2015). Organization drivers foster a more supportive administrative, funding,
policy, and procedure environment to ensure that the competency drivers are accessible
and efficacious (Ogden & Fixsen, 2015). Organization drivers also assure continuous
88
quality monitoring and improvement of outcomes through iterative improvement.
Leadership drivers discriminate between adaptive challenges and technical challenges to
implementation. Appropriate leadership strategies must be selected to establish,
repurpose, adjust, and monitor both competency and organization drivers throughout
implementation stages (Bertram, Blase, & Fixsen, 2015).
Figure 8: Implementation Drivers
Drivers exist at the organization, leadership, and competency levels. This model helps
identify deficiencies, test overall performance, make changes to correct deficiencies,
build consistent implementation plans, and deliver improved outcomes. Reproduced with
permission from (Fixsen & Blase, 2009).
89
Implementation drivers are viewed by Fixsen and colleagues (Fixsen et al., 2009) to have
profound effects on staff behavior and organizational culture. The components of the
implementation drivers are not always equally strong, but strength in one area can
compensate for weakness in another (Figure 8). Importantly, the implementation drivers
and their potential outcomes exist quite independently of the practice or program being
implemented; an ineffective practice or program can be implemented well, and
conversely, effective programs can be implemented poorly (Fixsen et al., 2009). Taken
together, implementation drivers affect the capacity to create practice, program, and
systems-level changes needed for improved outcomes (Bertram, Blase, & Fixsen, 2015).
These drivers function as the infrastructure elements necessary for effective
implementation that supports sustainable programs. Ongoing assessments are needed to
determine if the practice or program is a right fit for the particular organization, which, in
the case of biobanks, can be highly variable.
In the present work, the framework of Fixsen and collaborators (Blase & Fixsen, 2013;
Fixsen & Blase, 1993) would seem to be a useful place to begin an exploration of
continuity planning in biobanks. It may assist the research by dissecting it systematically
into a series of more focused areas that can be examined separately. The literature that
has been summarized here suggests that biobanks have few formal requirements for the
structure of such plans, despite their obvious vulnerabilities to numerous types of
stressors. Thus, it is interesting to investigate how academic biobanks are dealing with
long-term continuity planning. Of particular interest is not only the stage of
implementation at which they are operating, but what they see as the hurdles associated
90
with the various implementation drivers. Using a survey tool to explore these areas may
provide a broad base of information that would give a starting point to characterizing
these activities.
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CHAPTER 3. METHODOLOGY
3.1 Introduction
The purpose of this study was to explore the ways that biobanks have assessed and
implemented programs to assure the continuity of their operations. In the initial phase, a
draft survey instrument was developed to examine operational continuity of biobanks
based on the stages of implementation model of Fixsen and coworkers (Bertram et al.,
2015; Fixsen & Blase, 1993). In the second phase, a focus group of seasoned
practitioners in the biobanking sector was convened in order to solicit a critical
evaluation of that survey instrument. In the third phase, the finalized version of the
survey instrument was disseminated to targeted respondents in the biobank sector.
Finally, the collected data was analyzed to develop a snapshot of biobank programs and
practices.
3.2 Phase I: Survey Instrument Creation
The survey instrument developed here used a previously described survey by Aaron
Goldenberg and colleagues (2015) to solicit information related to biobank continuity as
a starting point. Additionally, the survey instrument also drew from a proposed list of
survey elements assembled in a previous publication by Susan Gibbons (2009) to assist in
describing biobanks. The questions within the Goldenberg survey were modified to
better fit the particular goals of this study. The scope of the typology elements described
by Gibbons were pared down to improve their usefulness for this study.
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The survey instrument had approximately 30 questions, grouped into three collections: (I)
elements related to demographics and general information; (II) elements that shape the
stages of biobank implementation of continuity; and (III) elements that capture the state
and importance of different implementation drivers on biobanking continuity planning.
Questions in the collections (I) section assessed the professional profile of the
respondents, their associated institutions, and the size and state of biobank activities done
at their locale. In section (II), questions were directed at assessing the level of current
continuity implementation and section (III) addressed the ways in which respondents
viewed the importance of the implementation drivers identified by the model and whether
additional elements were seen to be important but did not fit easily into the three-element
framework. The survey was constructed utilizing questions of the following types:
a) Multiple choice, with a set of options from which to choose;
b) Likert scale, with a rated continuum from strongly disagree (1) to strongly
agree (5) or from extremely unlikely (1) to extremely likely (5); and
c) Open ended questions requesting a text entry to expand on information
relevant to the choice-based questions and scales. (Note: these question
types were used sparingly, as they are difficult to code).
3.3 Phase II: Focus Group Critique of Survey Instrument
An initial focus group of 8 members was invited to examine and discuss the quality of the
survey questions prior to its circulation to the respondent pool. Members of the initial
focus group were selected from the University of Southern California (USC) Doctorate of
Regulatory Science (DRSc) program, USC School of Pharmacy faculty members, USC
Keck School of Medicine faculty members, USC Norris Comprehensive Cancer Center
researchers, Moffitt Cancer Center and Research Institute faculty, and the National
93
Marrow Donor Program. All of the individuals possessed sufficient background to
enable thoughtful discussion. The author assessed the availability and willingness of
each potential member to participate by contacting each individual either by face-to-face
meeting, phone, internet, or e-mail invitation. The focus group members invited are
described in the table below (Table 6).
Table 6: Survey Focus Group Members
Name Title(s)
Frances J. Richmond, PhD, BNSc,
MSc
Focus Group Co-chair
Director, USC International Center for Regulatory
Science
Michael Jamieson, DRSc Assistant Professor of Clinical Pharmacy
Associate Director, Education in Regulatory Science,
USC International Center for Regulatory Science
Eunjoo Pacifici, PharmD, PhD Assistant Professor of Clinical Pharmacy
Associate Director, Graduate Programs, USC
International Center for Regulatory Science
Nancy Pire-Smerkanich, DRSc Assistant Professor of Clinical Pharmacy, USC
International Center for Regulatory Science
Sue Ellen Martin, MD, PhD Associate Chief of Anatomic Pathology, USC Norris
Comprehensive Cancer Center
Associate Director of Anatomic Pathology, Quality and
Operations, Los Angeles County Medical Center
(LAC+USC)
Katherine St. Martin, MS Quality and Regulatory Services Project Manager at Be
the Match operated by National Marrow Donor
Program
Janet Villarmia, MBA, ML Associate Director for Administration and Education,
USC Norris Comprehensive Cancer Center
Team Lead, USC Norris Comprehensive Cancer
Center, Disaster Plan and Recovery
Erin M. Siegel, PhD Assistant Professor, Moffitt Cancer Center and
Research Institute
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The participants in the focus group were invited to meet for a 1.5-hour review session at
the USC Health Science Campus (HSC). The author provided participants with an
electronic draft of the survey in advance and a hard copy of the survey at the time of the
session. The USC Regulatory Science Program Office provided light refreshments at the
beginning of the focus group; during that time, the members of the focus group were
introduced to one another. The author then briefly introduced the study and then initiated
a discussion of each question sequentially. The information was consolidated from the
focus group feedback and suggestions. From those suggestions, a final version of the
survey was developed.
The final survey was reconfigured based on feedback from the focus group session and
published on a web-based survey platform, Qualtrics™ Insights Platform
(https://www.qualtrics.com/). A copy of the final questionnaire can be found in Appendix
A. The effective operation of the Qualtrics™ Insights Platform system was validated by
sending the survey to the individuals from the focus group to verify that emails arrive
properly and survey answers were able to be recorded and analyzed properly. Responses
from focus group members were excluded from the final analysis of data.
3.4 Phase III: Administration and Data Collection of Survey Instrument
The administration of the survey instrument relied on three critical activities. First, the
author gathered the necessary contact information and profiles of potential participants
from networks of individuals who participated in biobank research, sought from
university websites and documents, professional conferences, training seminars,
professional organizations, and personal networks. The key participants were individuals
95
who had roles as biobank staff, managers, and administrators and were responsible for
the day to day operations of biobank activities. Participants were asked if they could
provide contact information of other personnel in their extended professional network
who meet the selection criteria, and may be qualified to address the topic.
Second, the author prepared introductory, follow-up and closing messages using the
Qualtrics™ Insights Platform software by creating an invitation letter, thank you note,
and reminder note for those who had yet to complete their survey. The author then sent
the potential participants an invitation letter with an individualized hyperlink to the final
survey by means of a web-enabled hyperlink through the Qualtrics™ Insights Platform.
Potential respondents were assured that their responses would be anonymous, and that
they would be able to receive a copy of the results after the survey was analyzed. No
other recompense was provided to those respondents. The survey was activated and
deployed from 10 January 2017 to 28 February 2017 to ~175 potential participants. The
respondents who requested a summary of the results were provided a high-level overview
of the survey results after analysis.
3.5 Analysis of Data
Results from the surveys were collected anonymously and stored electronically in the
Qualtrics™ Insights Platform. Data from dichotomous questions (“yes/no”), multiple
choice questions (single and multiple responses), and rank order scaling questions were
graphed and analyzed statistically. Descriptive text, tables, and figures were utilized to
display the data.
96
Open text and comment fields were examined for their information content and analyzed
for textual trends and appearance of common elements or threads. Open text fields
provided context for participants’ answers, anecdotes for understanding motivations, and
opportunities for participants to tell their story with the most complete picture possible.
The open text and comments provided further insight into the three key implementation
drivers:
1) Organizational Drivers – Did the organization provide for systems level
intervention, facilitative administration, and / or decision-support data systems to
aid in understanding implementation performance for biobank continuity?
2) Leadership Drivers – Did the organization provide appropriate leadership support,
either technical or adaptive, for implementation and support of biobank
continuity?
3) Competency Drivers – Did the implementation of biobank continuity enhance the
selection, training, and coaching of biobank staff, managers, and administrators?
Depending on the stage of implementation, did the participant feel the process had
uncovered new efficiencies and ways to encourage their effectiveness?
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CHAPTER 4. RESULTS
4.1 Analysis of Survey Responses
The survey was distributed to 175 recipients by sending them personal email messages
with links to the survey between 10 January 2017 and 28 February 2017. The survey was
activated by 62 (35%; 62/175) participants, of which 57 participants answered at least
one question (33%; 57/175), with the remaining 5 (3%; 5/175) initiating the survey but
not answering any questions. Because the survey was marked as anonymous within
Qualtrics™ Insights Platform, there was no way to retrieve the email addresses of the 5
biobank professionals who aborted the survey prior to answering any questions to gain
insight as to why they did not complete.
4.2 Demographic Profiles
4.2.1 Respondent Profiles
Survey respondents classified their biobanks by selecting from a list of three choices and
the option to provide a text answer (Figure 9). Of the 45 individuals who answered this
question, nearly half worked for a biobank facility that they classified as an Academic
Center (44%; 20/45). Most of the others worked either for a Non-Profit Private Company
(27%; 12/45) or a For-Profit Private Company (22%; 10/45). Only one worked for a
Government Facility (2%; 1/45). Two additional respondents (4%; 2/45) selected
“Other” that they defined as a “Non-Profit Public Organization” and “For-Profit Private /
Governmental Alliance”.
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Respondents were questioned about their roles by providing four choices in either
administrative or operational categories as well as an “other” category that could be
specified by the respondent. Most of the 45 respondents self-identified as Administrative
(67%; 30/45), with job titles of director, program manager, or administrator. A minority
(22%; 10/45) saw themselves as Operational, with job titles of project manager, data
manager, or business manager. A few (11%; 5/45) selected “Other”, and self-reported
job titles including: “marketing / product management”, “technical director and
administrator”, “clinical researcher”, “executive”, and “I actually do all three
[administrative, operational, technical] as Co-Director”. No respondent self-identified as
belonging to a role described as Technical, which had job titles provided as examples
consisting of laboratory researcher or laboratory technician.
2%
44%
27%
22%
5%
I work for a…
Government facility Academic center Non-profit private company
For-profit private company Other
Figure 9: Respondent Reported Facility Type (N=45)
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Most respondents indicated that they had been working in the biobanking field for 3 years
or more (>6 Years: 56%; 25/45; 3-5 years: 29%; 13/45) (figure 11). Only a few had a
working history of 0-2 years (16%; 7/45).
Figure 10: Job Roles of Respondents (N=45)
67% 0%
22%
11%
My role is primarily...
Administrative Technical Operational Other
8%
14%
28%
50%
I have been working in biobanking for…
0-2 Years 3-5 Years >6 Years Total
Figure 11: Years in Biobanking (N=45)
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Most biobanks at which respondents were employed appeared to be relatively small.
When given three size ranges according to number of employees, the choice selected by
about half of the respondents was “<10 people” (51%; 23/45) (figure 12). An additional
third selected “11-49 people” (31%; 14/45), and only a small minority selected “>50
people” (18%; 8/45).
4.2.2 Biobank Profile
To gauge the purposes of the biobanks that employed the respondents, respondents were
given a number of options from which they could “check all that apply” (Figure 13). The
most frequent choice by a significant margin was basic / translational research (84%;
38/75). Clinical trials were selected by about one-third of the respondents (31%; 14/75),
followed by observational / epidemiology research (22%; 10/75), diagnostic (18%; 8/75),
and “other” (11%; 5/75) of survey respondents. “Other” had an open text-box field to
51%
31%
18%
My unit / department employs…
<10 People 11-49 People >50 People
Figure 12: Respondent-Reported Department Size (N=45)
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allow respondents to suggest other choices, and elicited responses that included:
“pregnancy research”, “distribution for research use”, “for future development of cellular
therapies”, “commercial tissuebank” and “research community”.
To understand the types of specimens in the banks of the respondents, a list of 11 types of
specimens was provided, with the options to indicate which of the specimens they were
current collecting and which they planned on collecting in the future (figure 14). Almost
all respondents identified that their banks held tissue (97%; 38/39) and/or blood, defined
as DNA, RNA, or whole blood (95%; 41/43). Also, commonly collected were urine
(28/33), swabs (17/20), saliva (79%; 22/28), cells and cell lines (77%; 24/31),
“Cerebrospinal Fluid (CSF)” (71%; 15/21), feces (69%; 9/13), and whole organs (64%;
7/11), and least frequently, nail clippings (50%; 3/6). The category “other” had 5
responses of currently included items (100%; 5/5) that included: “ascites, hair follicle,
84%
22%
18%
31%
11%
The primary purpose for my biobank is...
Basic research Observational research Diagnostic Clinical trials Other
Figure 13: Purpose for Biobanking reported by Respondents (multiple choice
permitted) (N=75)
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synovial fluid”; “tissue RNA/DNA”; “ascites, sputum, brain, cell lines”; “bone marrow
aspirate, urine, PBMCs, granulocytes”; and “serum, plasma, whole blood, paxgene tubes,
bone marrow, ascetic fluid”. The maximum number of respondents who indicated either
their current or future collection was 43, as the question was designed to be check all that
apply some responses were low while others were high for the predefined list of
specimens (Table 7).
Table 7: Reported Collections - Current and Future (N=43)
The specimens include…
Specimen Type
Current
Collection
Future
Collection
Urine
85%
(28/33)
15%
(3/33)
Blood
95%
(41/43)
7%
(3/43)
Tissue
97%
(38/39)
5%
(2/39)
Cell and cell lines
77%
(24/31)
27%
(8/31)
Whole organs
64%
(7/11)
36%
(4/11)
Feces
69%
(9/13)
31%
(4/13)
Nail clippings
50%
(3/6)
50%
(3/6)
CSF
71%
(15/21)
29%
(6/21)
Swabs
85%
(17/20)
15%
(3/20)
Saliva
79%
(22/28)
21%
(6/28)
Other
100%
(5/5)
0%
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The “planned for the future” collection of specimens indicated by respondents had
significantly fewer responses per answer (Table 7). Nail clippings were the first group of
specimens indicated for future collection by 50% (3/6) of respondents. Whole organs
(36%; 4/11), feces (31%; 4/13), “CSF” (29%; 6/21), cells and cell lines (27%; 8/31), and
saliva (21%; 6/28) were the specimens most likely to planned for future collection and
storage. Urine (15%; 3/33) and swabs (15%; 3/20) were tied. blood (DNA, RNA, or
whole blood) was 7% (3/43) and tissue was 5% (2/39) of the specimens to be targeted for
future collection and storage by biobanks (Figure 14).
Figure 14: Reported Specimen Collection - Current and Future (N=43)
85%
15%
95%
7%
97%
5%
77%
27%
64%
36%
69%
31%
50%
50%
71%
29%
85%
15%
79%
21%
100%
0%
0%
20%
40%
60%
80%
100%
120%
Current Future
The speciments include…
Urine Blood Tissue Cells and cell lines
Whole organs Feces Nail clippings CSF
Swabs Saliva Other
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The final element in the biobank profile section asked respondents to select one of three
pre-defined answers reflecting the length of time for which the biobank has been in
operation. Most of the respondents (82%; 37/45) indicated that their biobank has been in
operation for >6 years (Figure 15). The remaining minority of respondents worked for
biobanks that had been operating for 3-5 years (16%; 7/45) or 0-2 years (2%; 1/45)
respectively.
Figure 15: Years of Biobank Operation Reported by Respondents (N=45)
2%
16%
82%
My biobank has been in operation for…
0-2 Years 3-5 Years >6 Years
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4.2.3 Profile of Disaster Vulnerabilities
Respondents were asked whether or not their biobank was located in an area prone to
natural disasters, to which most answered no [ “yes” (36%; 16/45); “no” (64%; 29/45)]
(Figure 16).
Respondents who answered “yes” were given a follow-up question in which a list of pre-
defined natural disasters was provided. Respondents were asked to identify whether the
“disaster exists” and if “disaster [has been] experienced” (Figure 17). The most common
disaster threats that existed in the area where the biobank was located included
earthquakes, identified by 67% (10/15) and floods, by 64% (9/14). Tornadoes (43%;
6/14), hurricanes (40%; 6/15), snow emergencies (33%; 5/15), and wild fires (29%; 4/14)
represented some of the less frequently identified natural disasters. Landslide / mudslides
(7%; 1/14), tsunamis (7%; 1/14), and volcanic activity (7%; 1/15) were least commonly
Figure 16: Biobanks Reported in Potential Disaster Areas (N=45)
36%
64%
Is your biobank located in an area prone to natural disasters?
Yes No
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selected. “Other” natural disasters (33%; 2/6) entered by respondents in a text box
included “draught” and “power outage”. Disasters that had been experienced included
earthquakes by 36% (5/14), snow emergencies by 21% (3/14), hurricanes by 20% (3/15),
floods by 8% (1/13), and tornadoes by 7% (1/14). One “other” natural disaster
introduced in a text box was draught (14%; 1/7). Without a mechanism to identify the
respondent who entered this response it was not possible to ask additional follow-up
questions for additional clarity about the impact of that type of crisis on biobank
operations.
Figure 17: Identification of Biobank Vulnerability to Potential and Experienced
Disasters (N=15)
33%
7%
67%
43%
40%
64%
7%
7%
29%
33%
0%
21%
0%
36%
7%
20%
8%
0%
0%
0%
14%
0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Those natural disasters are…
Disaster Exists Disaster Experienced
107
When asked whether their biobank has a continuity of operations plan (Figure 18), most
respondents (78%; 36/46) selected “yes”. The few who responded “no” (3%; 3/46) were
taken to Section IV, the end of the survey. Those who indicated “I do not know” (15%;
7/46) were taken to the next section, Section II, of the survey. The respondents who
selected “yes” were asked to indicate how long their plan had existed (Figure 19).
Somewhat more than half identified that their plans had been in place for “>6 Years”
(56%; 20/36). The others worked for biobanks in operation for “0-2 Years” (25%; 9/36)
or “3-5 Years” (19%; 7/36).
Figure 18: Presence or Absence of a Biobank Continuity Plan (N=46)
78%
7%
15%
Does your biobank have a continuity of operations plan?
Yes No I do not know
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4.3 Research and Development Implementation Phase
4.3.1 Barriers and Hurdles During Research and Development
Section II of the biobank continuity survey explored the processes used by respondents
during the research and development of their biobank continuity plans.
Respondents were asked if barriers hindered either the research or development phases of
their continuity planning. Nearly half (47%; 20/43) answered “no” and a further third
(35%;15/43) answered “I do not know”. The minority (19%; 8/43) who selected “yes”
were asked to select those barriers (Figure 20).
“Research phase barriers”. Four responses were selected as the top barriers during their
research phase: limited financial resources (5/5), limited personnel resources (5/5),
attempting to evaluate every potential hazard (5/5), and unable to agree on size / extent of
Figure 19: Length of time for which a Continuity Plan Years Has Operated (N=36)
25%
19%
56%
The continuity of operations plan has been in place for…
0-2 Years 3-5 Years >6 Years
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plan (4/5). Less commonly selected were poor cooperation from other departments and
information technology challenges (3/5 each); burdensome data collection / research and
failure of institutional leadership (2/4 each); resistance from biobank stakeholders,
resistance to change, and lack of federal, institutional, or local guidance (2/5 each); slow
scientific or ethical review board approval (1/5). The option “other” was not selected by
any respondents (0/5).
“Development phase barriers”. Three responses were chosen as the top hurdles
experienced by respondents during the development of their continuity plans: unable to
agree on size / extent of plan (4/5), limited financial resources (5/5), and limited
personnel resources by (4/5). Less frequently chosen were burdensome data collection /
research, lack of federal, institutional, or local guidance, and attempting to evaluate every
potential hazard (3/5 each); failure of institutional leadership, slow scientific or ethical
review board approval, and resistance from biobank stakeholders (2/5 each); information
technology challenges (2/6). Infrequent choices were poor cooperation from other
departments and resistance to change (1/4 each). The option “other” was not selected
(0/0) by any respondents as a hurdle during development.
Respondents who had experienced barriers during the creation of their continuity plan
(8/43) were then asked to indicate their biggest hurdles (Figure 21). The seven responses
chosen as the biggest hurdle varied, from limited personnel resources (2/6), limited
financial resources, poor cooperation from other departments, failure of institutional
leadership, slow scientific or ethical review board approval, resistance from biobank
stakeholders, and resistance to change (1/6 each). Twelve responses were chosen as
110
moderate hurdle by respondents in trying to develop their continuity plan. The most
commonly chosen five included moderate hurdles chosen by (5/6) were information
technology challenges, burdensome data collection / research, limited financial resources,
lack of federal, institutional, or local guidance, and attempting to evaluate every potential
hazard. Two, including unable to agree on size / extent of plan, and limited personnel
resources, were selected by (4/6) of respondents, and three, poor cooperation from other
departments, failure of institutional leadership, and slow scientific or ethical review board
approval were chosen by (2/6). A single respondent (1/6) selected resistance from
biobank stakeholders and resistance to change each. The category “other” was not
selected (0/6) by any of the responders for this question.
111
Figure 20: Hurdles During Research and Development of Continuity Plans (N=6)
3/5
3/5
4/5
1/2
1/2
1/5
2/5
5/5
5/5
2/5
2/5
5/5
0
1/3
1/5
4/5
3/5
2/5
2/5
2/5
5/5
4/5
1/5
3/5
3/5
0
Please indicate the elements that presented hurdles during the research
(investigating the plan) and devlopment (drafting of the plan) phases of your
continuity planning activities.
Research Phase Development Phase
112
Figure 21: Biggest Hurdles During Development (N=6)
1/6
1/2
1/3
0
1/2
1/2
2/3
0
0
2/3
0
0
0
5/6
1/3
2/3
5/6
1/3
1/3
1/6
5/6
2/3
1/6
5/6
5/6
0
0
1/6
0
0
1/6
1/6
1/6
1/6
1/3
1/6
0
1/6
0
0
0
0
1/6
0
0
0
0
0
0
1/6
0
0
What do you perceive as the biggest hurdles in trying to develop your continuity
plan?
Not a hurdle Moderate hurdle Biggest hurdle Do not know
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4.3.2 Standard Operating Procedures to Incorporate Continuity
Broadly speaking, Standard Operating Procedures (SOPs) are documented processes that
an organization puts in place to ensure that services and procedures are carried out
consistently every time. SOPs that incorporate the continuity of operations into a
biobank workflow can be used as a marker to signify an advanced stage of
implementation because it suggests that replication, training, and evaluation are occurring
at regular intervals (Figure 22). Most of the survey respondents, 80% (33/41) had
developed an SOP. The remaining 8 respondents either had not developed an SOP (10%;
4/41) or did not know (10%; 4/41).
Respondents who had an SOP to incorporate continuity into their workflow were asked to
select elements they had incorporated into their own SOPs from a list of 14 pre-populated
Figure 22: Reported Number of Standard Operating Procedures (N=41)
80%
10%
10%
My biobank developed an Standard Operting Procedure
Yes No I do not know
114
elements. The elements were chosen because they represented key competency and
organizational drivers of implementation. The better these drivers are integrated, the
greater should be overall program performance and consistency. For each of the 14
elements, respondents were asked to select whether the element was “considered and
incorporated”, “considered, not incorporated”, “not considered” or “do not know” (Table
8).
Table 8: Elements Reported as Included in SOPs (N=27)
Element
Considered
and
Incorporated
Considered,
Not
Incorporated
Not
Considered
Do Not
Know
Evacuation plans for
emergencies
93%
(25/27)
4%
(1/27)
0%
4%
(1/27)
A mechanism to isolate
equipment failures
89%
(24/27)
0%
4%
(1/27)
7%
(2/27)
Assessment of best practices
85%
(23/27)
4%
(1/27)
7%
(2/27)
4%
(1/27)
A method for decision making
in crisis situations
85%
(23/27)
0%
11%
(3/27)
4%
(1/27)
Contingency plans for
identified threats
81%
(22/27)
8%
(2/27)
4%
(1/27)
8%
(2/27)
Notification for non-routine
internal communication
78%
(21/27)
12%
(3/27)
8%
(2/27)
4%
(1/27)
A mechanism to incorporate
feedback and data to improve
planning
67%
(18/27)
19%
(5/27)
12%
(3/27)
4%
(1/27)
A mechanism to assess threats
67%
(17/27)
15%
(4/27)
15%
(4/27)
4%
(1/27)
Ongoing cost projection
evaluation
63%
(17/27)
8%
(2/27)
15%
(4/27)
15%
(4/27)
115
The top element that was considered and incorporated by 93% (24/26) of survey
respondents into their SOPs was an evacuation plan for emergencies (Figure 23). Five
elements considered and incorporated by between 70 and 90 percent of respondents
included: a mechanism to isolate equipment failures (89%; 24/27), assessment of best
practices (85%; 23/27), a method for decision making in crisis situations (85%; 22/27),
contingency plans for identifying threats (81%; 22/27), and notification guidelines for
non-routine internal communication (78%; 21/27). Four elements were considered and
incorporated by between 50 and 70 percent of respondents included: a mechanism to
incorporate feedback and data to improve planning (67%; 18/27), a mechanism to assess
threats (67%; 17/27), ongoing cost project evaluation (63%; 17/27), and periodic budget
evaluation (59%; 16/27). Three elements considered and incorporated by between 40 to
50 percent of responders involved: a mechanism for biobank closure (44%; 12/27), a
mechanism to identify internal administrative barriers (41%; 11/27), and a method to
Element
Considered
and
Incorporated
Considered,
Not
Incorporated
Not
Considered
Do Not
Know
Periodic budget evaluation
59%
(16/27)
8%
(2/27)
15%
(4/27)
15%
(4/27)
A mechanism for biobank
closure
44%
(12/27)
8%
(2/27)
35%
(9/27)
12%
(3/27)
A mechanism to identify
internal administrative barriers
41%
(11/27)
31%
(8/27)
22%
(6/27)
4%
(1/27)
A method to mitigate
administrative barriers
41%
(11/27)
31%
(8/27)
22%
(6/27)
4%
(1/27)
Other
33%
(1/3)
0%
0%
67%
(2/3)
116
mitigate administrative barriers (41%; 11/27). “Other” elements were considered and
incorporated by a single respondent that was not elaborated on in the associated open text
comment field.
Figure 23: Elements Considered and Incorporated into Continuity SOPs (N=27)
67%
41%
41%
67%
89%
85%
81%
78%
85%
44%
59%
63%
33%
19%
33%
33%
15%
0%
0%
7%
4%
11%
4%
7%
7%
7%
0%
11%
22%
22%
15%
4%
11%
4%
0%
7%
7%
37%
19%
15%
0%
4%
4%
4%
4%
7%
4%
7%
4%
4%
4%
11%
15%
15%
67%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Please indicate the elements considered for incorporation into your SOP…
Considered and Incorporated Considered, Not Incorporated Not Considered Do Not Know
117
4.3.3 Crises and Disasters Considered for Continuity Planning
Respondents were asked to indicate if crises or disasters had been considered within their
continuity of operations (Figure 24). Seven targeted items were provided for which
respondents were asked to identify if the item was “considered and incorporated”,
“considered, not incorporated”, “not considered”, or “do not know” (Table 9). The
categories of disasters and crises were drawn on the Ishikawa diagram from Chapter 2
(Figure 3). These categories relate to organizational and leadership drivers of
implementation. Two interesting observations arise from Table 9: 1) there are a large
number of “do not know” among the respondents (Figure 24), and 2) the difference
between “considered and incorporated” and “considered, not incorporated” (Figure 25).
Table 9: Crises Considered and Incorporated in Continuity SOPs (N=32)
Item
Considered
and
Incorporated
Considered,
Not
Incorporated
Not
Considered
Do Not
Know
Physical crises
(e.g.: accidents, equipment failure, loss of
power)
84%
(27/32)
6%
(2/32)
0%
9%
(3/32)
Natural disasters
(e.g.: volcanic eruptions, earthquakes, floods)
69%
(22/32)
13%
(4/32)
9%
(3/32)
9%
(3/32)
External agent crises
(e.g.: terrorism, product tampering, cybercrime,
information theft, information ransom)
41%
(13/32)
16%
(5/32)
28%
(9/32)
16%
(5/32)
Reputation crises
(e.g.: internet defamation, malicious rumors,
false accusations)
39%
(12/31*)
16%
(5/31*)
32%
(9/31*)
13%
(4/31*)
Personnel crises
(e.g.: criminal actions, large scale illness, large
scale death, disgruntled employee)
31%
(10/32)
34%
(11/32)
22%
(7/32)
13%
(4/32)
Political / economic crises
(e.g.: change in government, change in
institutional leadership, change in funding,
business failure, accounting problems)
22%
(7/32)
34%
(11/32)
28%
(9/32)
16%
(5/32)
118
Item
Considered
and
Incorporated
Considered,
Not
Incorporated
Not
Considered
Do Not
Know
Other crises
0%
0%
25%
(1/4)
75%
(3/4)
* - This question was answered by 31 respondents.
Respondents were also asked to “indicate if your continuity of operations plan has taken
the following elements into account” and were provided with 7 options (Figure 24).
Amongst the 32 respondents who answered the question, most (84%; 27/32) identified
that they had considered and incorporated physical crises (e.g.: accidents, equipment
failure, loss of power) into their continuity plans. Many (69%; 22/32) also considered
and incorporated natural disasters (e.g.: volcanic eruptions, earthquakes, floods). Less
frequently considered and incorporated were external agent crises (e.g. terrorism, product
tampering, cybercrime, information theft, information ransom) (41%; 13/32); and
reputation crises (e.g. internet defamation, malicious rumors, false accusations) (39%;
12/31) and personnel crises (e.g.: criminal actions, large scale illness, large scale death,
disgruntled employee) (31%; 10/32). The least selected element to be considered and
incorporated was that of political / economic crises (e.g.: change in government, change
in institutional leadership, change in funding, business failure, accounting problems)
(22%; 7/32). No respondent identified that they had considered and incorporated “Other
crises” (0%; 0/4). The option of “other” crises did not receive much merit, but was
selected as “not considered” by 25% (1/4) and “do not know” by 75% (3/4) of survey
respondents. Respondents went on to describe “other” crises by providing their own
definitions of “reputation, natural disasters, theft”, “cessation of institutional funding”,
and “plan not created”.
119
9%
13%
16%
16%
9%
13%
91%
87%
84%
84%
91%
87%
Phy sica l crises
Perso nnel crises
Po litica l / eco no mic crises
Externa l a g ent crises
Na tura l disa sters
Reputa tio n crises
Plea se ind ica te if yo ur co ntinuity o f o p era tio ns p la n ha s ta k en
the fo llo wing elem ents into a cco unt…
Do Not Know All Other Responses
Figure 25: Disaster Elements Considered in Continuity SOPs (N=32)
0
5
10
15
20
25
30
Incorporated Not Incorporated
Respondents
Elements Considered
Please indicate if your continuity of operations plan has taken the following
elements into account…
Physical crises Personnel crises Political / economic crises
External agent crises Natural disasters Reputation crises
Figure 24: Disaster Elements Incorporated Vs. Not Incorporated (N=32)
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4.3.4 Guidance Documents Referenced During Continuity Plan Development
Respondents were asked to about the guidance documents they had utilized to help
develop their continuity plan by indicating if they were “aware of guidance” and if they
“utilized guidance” (Figure 26). The number of respondents per guidance document
varied between 24-29. The three documents with which most respondents were aware
included NCI Biorepository Best Practices (NCI BBP) (79%; 23/29); the Health
Insurance Portability and Accountability Act (HIPAA) requirements (74%; 20/27); and
the International Society for Biological and Environmental Repositories (ISBER) best
practices (72%; 21/29). Half or fewer of respondents were aware of the existing
institutional plan guidance document (50%; 13/26); the Federal Emergency Management
Agency (FEMA) continuity planning strategies (37%; 10/27); the ISO 22301:2012
Societal Security – Business Continuity Management Systems – Requirements (35%;
9/26); and the Pandemic and All Hazards Preparedness Act (PAHP) documents (24%;
5/25).
A similar pattern of preference was observed when respondents identified the documents
that they referenced in operationalizing their plans. In order of preference, the most
commonly selected references were the Health Insurance Portability and Accountability
Act (HIPAA) requirements (65%; 17/26); the International Society for Biological and
Environmental Repositories (ISBER) best practices (62%; 16/26); and the NCI
Biorepository Best Practices (BBP) (62%; 16/26). The remaining documents were
selected by less than half of the respondents: Supplement to existing institutional plan
(42%; 10/24); ISO 22301:2012 Societal Security – Business Continuity Management
121
Systems – Requirements (25%; 6/24); Pandemic and All Hazards Preparedness Act
(PAHP) Stipulations 25% (6/24); and Federal Emergency Management Agency (FEMA)
Continuity Planning Strategies (24%; 6/25).
Figure 26: Reported Awareness and Utilization of Guidance (N=29)
79%
35%
72%
74%
37%
24%
50%
62%
25%
62%
65%
24%
25%
42%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
NCI BBP ISO 22301 ISBER HIPAA FEMA PAHP Existing plan
Please indicate the guidance document(s) that you used as a reference
when you developed your continuity plan…
Aware of Guidance Utilization of Guidance
122
Respondents were provided with an open text comment box and asked to share any
additional comments or advice they could provide with regards to development of
continuity plans. Ten respondents commented (Table 10).
Table 10: Respondent Comments Regarding Developing Continuity Plan (N=10)
Can you please share any advice or words of wisdom from your experience in developing
continuity plans?
Utilization of the specimens is key. If the organization is just collecting for future use but does
nothing with the samples then there is no return on the investment. The samples are precious
and patients donated these in an effort to progress science not sit and forgotten in a freezer.
Try to involve as many people / departments as possible in order to maximize your options.
Ensure that the protocols are well established with regards to patient consent and procurement.
Evaluate physical plant (electrical, HVAC, sustainability) – Ensure that the purchases of
freezers are for long-term purposes and provide security measures with regards to handling of
specimen and chain of custody.
Achieving CAP accreditation focused our need for a continuity plan.
Current plan is based on the previous owner of our site Pfizer.
After being exposed to this survey, I will start developing a plan.
I do not believe we have a continuity of operations plan just for the biobank. I am sure the
health system in its entirety has a continuity of operations plan, but that it focuses on patient
care and not research.
There is no need to recreate the wheel – there are many resources available to help in
developing operation plans
Earthquakes are a potential problem. We may not be accessible due to freeway collapses, etc.
Thus, delivery of diesel for back up generators is a problem. Must consider commercial
biobanks that may be able to house your freezers.
Our experience show that power failure is most common, comparing to all other risks.
123
4.4 Evaluation of Continuity Plan
4.4.1 Formal Review Process
Section III of the survey was focused on understanding more advanced or mature
practices as related to stage of implementation. Section III leverages how organizations
evaluate and address key aspects of implementation to obtain a consistent and
reporducable program.
The approaches used to evaluate continuity plans were explored by first identifying the
subgroup of respondents whose biobanks had a formal review process to promote
improvements (Figure 27). About one fifth of the 33 respondents who answered this
question did not know if evaluations were carried out (21%; 7/33). Of the others, many
more respondents had an evaluative process (51%; 17/33) than did not (18%; 6/33). Most
commonly, that evaluation was conducted yearly (36%; 12/33). “Yes… but only when
thought to be needed” was selected by 15% (5/33). “Other” was selected by 3
respondents who gave the alternative responses of working on implementation; 2 years;
and scheduled every 3 years.
124
Respondents who selected “yes, as needed” and “yes, annually” as the frequencies with
which their continuity plan underwent formal review were asked whether certain areas of
activity and accountability items were reviewed. They were asked to indicate if that item
was: “in place”, “partially in place”, “not in place”, or “do not know”. (Figure 28).
When asked if biobank staff were actively engaged in reviewing the continuity plan only
1 of the 5 respondents selected “in place”; the other 4 selected “partially in place”. When
asked if individuals were held accountable for maintaining an updated continuity plan,
two of 5 selected “in place” and 3 selected “partially in place”. When asked if elements
of the continuity of operations plan were reviewed and tested annually, 2 of 5 selected “in
place”, 2 as “partially in place”, and one as “not in place”. When asked if role-playing /
Figure 27: Timing of Updates to SOPs to Incorporate Improvements (N=33)
15%
18%
37%
9%
21%
Does your biobank continuity of operations plan have a formal review process
to promote improvements?
Yes, as needed No Yes, annually Other Do not know
125
performance of the process and procedures involved in the continuity plan are conducted,
3 of 5 chose “partially in place” and 2 chose “not in place”.
4.4.2 Evaluation of Continuity Plan
Respondents were provided with a list of 10 predefined items and asked if they had
considered or incorporated these items into their continuity plan (Figure 29). The first
Figure 28: Life-Cycle Elements Incorporated into Continuity Plans (N=5)
1/5
4/5
0
0
2/5
3/5
0
0
2/5
2/5
1/5
0
0
3/5
2/5
0
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Please indicate the life-cycle elements currently in place for your continuity plan…
Staff engaged in review Accountability for maintaining and updating
Annual review and test Role-playing procedures
126
item, we performed a risk assessment to identify potential hazards was “considered and
incorporated” by 72% (23/32); “considered, not incorporated” by 6% (2/32); and “not
considered” by 3% (1/32). Six respondents (19%; 6/32) did not know. The item, we
evaluated current processes to determine critical elements required to maintain or return
to ‘steady state’ day-to-day operations was “considered and incorporated” by 78%
(25/32) and “not considered” by 3% (1/32). Six respondents (19%; 6/32) again did not
know. We evaluated our information technology for vulnerabilities was “considered and
incorporated” by 81% (26/32) and “not considered” by 3% (1/32); five respondents
(16%; 5/32) did not know. We evaluated our security protocols for access to our
biobank, was “considered and incorporated” by 84% (26/31) and “not considered” by 6%
(2/31); three (10%; 3/31) did not know. We evaluated our physical work space for
potential hazards was “considered and incorporated” by 84% (27/32); “considered, not
incorporated” by 3% (1/32); and “not considered” by 3% (1/32). Three (9%; 3/32) did
not know. We evaluated our freezers and storage conditions was “considered and
incorporated” by 88% (28/32) and “not considered” by 3% (1/32). Three (9%; 3/32) did
not know. We evaluated offsite storage (samples) was “considered and incorporated” by
44% (14/32); “considered, not incorporated” by 25% (5/32); and “not considered” by
19% (6/32). Four (13%; 4/32) did not know. We evaluated offsite storage (data) was
“considered and incorporated” by 56% (18/32); “considered, but not incorporated” by
13% (4/32) and “not considered” by 16% (5/32). Five (16%; 5/32) did not know. We
evaluated system redundancies was “considered and incorporated” by 63% (20/32);
“considered, not incorporated” by 19% (6/32) and “not considered” by 6% (2/32). Four
(13%; 4/32) did not know. Only 5 respondents selected “Other”; one stated that it was
127
“not considered” but the other 4 selected “do not know” by 80% (4/5). No comments
were provided in the “other” comment text field.
Respondents were asked to indicate the frequency with which certain elements had been
reviewed since the implementation of their continuity plans (Figure 30), and given 6
Figure 29: Level of Consideration to Various Elements Important for the
Evaluation of the Continuity Plan (N=32)
72%
6%
3%
19%
78%
0%
3%
19%
81%
0%
3%
16%
84%
0%
6%
10%
84%
3%
3%
9%
88%
0%
3%
9%
44%
25%
19%
13%
56%
13%
16%
16%
63%
19%
6%
13%
0%
0%
20%
80%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Please rate the level of consideration given to the following items during
the evaluation of your continuity plan…
Risk assessment Evaluate "steady-state" elements
IT evaluation Security access evaluation
Physical work space evaluation Freezer & storager evaluation
Evaluate offsite samples Evaluate offsite data
Evaluate system redundancies Other
128
different options for those frequencies, including “immediately, as soon as possible”;
“every 6 months”; “every 12 months”; “informally, other”; “never”; and “do not know”.
The first element, we adjust our continuity plan based on a new risk identification and
assessment was indicated as being reviewed “immediately, as soon as possible” by 44%
(14/32); “every 6 months” by 6% (2/32); “every 12 months” by 13% (4/32); “informally,
other” by 13% (4/32); “never” by 6% (2/32). “Do not know” was selected by 19% (6/32)
of survey respondents. We adjust our continuity plan based on an assessment of our
information technology was carried out “immediately, as soon as possible” by 19%
(6/32); “every 6 months” by 6% (2/32); “every 12 months” by 28% (9/32); “informally,
other” by 19% (6/32); “never” by 6% (2/32); and “do not know” by 22% (7/32). We
adjust our continuity plan based on structural assessment of our physical space was
carried out “immediately, as soon as possible” by 25% (8/32); “every 6 months” by 6%
(2/32); “every 12 months” by 25% (8/32); “informally, other” by 16% (5/32); “never” by
6% (2/32); and “do not know” by 22% (7/32). We adjust our continuity plan based on
institutional policies or requirements was carried out “immediately, as soon as possible”
by 22% (7/32); “every 6 months” by 13% (4/32); “every 12 months” by 16% (5/32);
“informally, other” by 25% (8/32); “never” by 6% (2/32); and “do not know” by 19%
(6/32). We adjust our continuity plan based on government guidance was incorporated
“immediately, as soon as possible” by 19% (6/31); “every 12 months” by 19% (6/31);
“informally, other” by 26% (8/31); “never” by 13% (4/31); and “do not know” by 23%
(7/31). The final element, we adjust our continuity plan based on budget and financial
concerns was evaluated “immediately, as soon as possible” by 25% (8/32); “every 6
months” by 3% (1/32); “every 12 months” by 19% (6/32); “informally, other” by 22%
129
(7/32); “never” by 9% (3/32); and “do not know” by 22% (7/32). An open text comment
field was associated with the response “informally, other”, and garnered 7 responses
(Table 11).
Table 11: Regarding Additional Elements Considered During Evaluation of the
Continuity Plan (N=7)
Please indicate the other items given consideration during the evaluation of your continuity
plan...
As needed. Much of this was designed prior to my arrival to the department so I am learning
and trying to implement new processes.
Quarterly
Annually
As needed
Informally as determined by management review. How drastic is the event, how much risk
does the event put us in, those kind of things are evaluated.
Every two years or sooner as issues arise
2 years
130
4.4.3 Training as part of Continuity Planning
Respondents were asked to indicate how specific training elements were utilized in
association with their continuity of operations plan (Figure 31), and were furnished with
4 response options including: “orientation”, “annually”, “never”, and “do not know”. For
each of the 6 training elements, the most common frequency of delivering the training
Figure 30: Level of Consideration Given to Items During Evaluation of Continuity
Plan (N=32)
72%
6%
3%
19%
78%
0%
3%
19%
81%
0%
3%
16%
84%
0%
6%
10%
84%
3%
3%
9%
88%
0%
3%
9%
44%
25%
19%
13%
56%
13%
16%
16%
63%
19%
6%
13%
0%
0%
20%
80%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Please rate the level of consideration given to the following items during
the evaluation of your continuity plan…
Risk assessment Evaluate "steady-state" elements
IT evaluation Security access evaluation
Physical work space evaluation Freezer & storager evaluation
Evaluate offsite samples Evaluate offsite data
Evaluate system redundancies Other
131
element was “annually”. A review of [the] written plan was carried out during
“orientation” by 16% (5/32), “annually” by 59% (19/32), “never” by 9% (3/32), and “do
not know” by 16% (5/32) of survey respondents. Role play of key scenarios was
performed at “orientation” by 13% (4/31), “annually” by 35% (11/31), “never” by 32%
(11/31), and “do not know” by 19% (6/31). A test of knowledge base was carried out at
“orientation” by 19% (6/32), “annually” by 44% (14/32), “never” by 16% (5/32), and “do
not know” by 22% (7/32). Cross functional training of staff for emergency preparedness
was carried out at “orientation” by 22% (7/32), “annually” by 44% (14/32), “never” by
16% (5/32), and “do not know” by 22% (6/32). A review of [the] evacuation plan was
conducted at “orientation” by 19% (6/32), “annually” by 56% (18/32), “never” by 9%
(3/32), and “do not know” by 16% (5/32). A review of delegation of responsibilities
during a crisis was chosen as occurring at “orientation” by 16% (5/32), “annually” by
59% (19/32), “never” by 6% (2/32), and “do not know” by 19% (6/32).
132
Respondents were provided with an open text comment field and asked to provide any
additional comments related to training techniques they may have incorporated that was
not previously mentioned. Six respondents provided comments shown in Table 12.
Figure 31: Frequency with Which Personnel Are Trained on Content of Continuity
Plans (N=32)
16%
59%
9%
16%
13%
35%
32%
19%
19%
44%
16%
22%
22%
44%
16%
19%
19%
56%
9%
16%
16%
59%
6%
19%
0%
10%
20%
30%
40%
50%
60%
70%
Please indicate how frequently you utilize the following training elements for
your continuity of operations plan…
Review written plan Role play scenarios
Test knowledge base Cross training staff emergency preparedness
Review evacuation Plan Delegate responsibilities during crisis
133
Table 12: Other Training Methods Incorporated by Respondents
Can you please tell us about any other training methods that you have incorporated?
Set up scenarios and see how staff react to the situation.
Biosafety and hazardous materials.
1) Read and understand
2) Personal training
3) Online training (webinars, Skype conferences with screen share, etc.)
Review the above during 3-year plan review.
Institution annual trainings
Employee quizzes as part of the biorepository’s Annual Competency Assessment required to
maintain our CAP Biorepository Accreditation.
Respondents were presented with an open text comment field and asked to share any
insights not previously discussed on either implementing or evaluating their continuity of
operations plan. Six respondents shared their experiences (Table 13).
Table 13: Experience with Regard to the Implementation or Evaluation of the
Continuity Plan
Please provide any comments or words of wisdom you would like to share about your
experience with implementing or evaluating your continuity of operations plan.
Stay on top of it. New staff need to be involved as well.
Changes of research administration or leadership are the most dangerous factors.
All updates in SOPs and forms are immediately fed to the personnel. Re-training is enforced
then. Thus, following orientation course, the training is continuous.
134
Please provide any comments or words of wisdom you would like to share about your
experience with implementing or evaluating your continuity of operations plan.
Encumbered process. Have to have buy-in from leadership and board to ensure they
understand what a bio-bank is, and provide them with a SWOT analysis. Some boards feel that
you can “monetize”; your biobank and get a Return on Investment. However, there are many
regulatory and compliance issues that are involved and can't just make a “business decision”.
Pay attention to HIPAA, tissue procurement, QA and processes. De-identification of sample is
a MUST. Have a good data management system that provides a wealth of information. Work
closely with the IRB.
Not easy but a worthwhile process. We are fortunate to have guidance and assistance from our
university administration and so didn’t have to start from scratch.
Complicated, time consuming and not infallible…based on financial considerations (which is
problematic) and options (which are limited).
4.5 Future Thinking on Continuity Regulations
Respondents were asked to consider future concerns that they considered to be most
concerning from their experience in the field (Figure 32). Eleven pre-defined regulatory
concerns were provided and respondents were asked to choose one of four answers for
each concern (Table 14). Based upon respondent’s choices, eight top concerns emerged.
Revised federal guidance was chosen as “very concerned” by 44% (14/32). Mandated
continuity of operations was chosen by 31 people and was selected as “somewhat
concerned” by 42% (13/31). International regulations were chosen as “somewhat
concerned” by 41% (13/32). Cooperative group / federated biobanking was chosen as
“somewhat concerned” by 38% (12/32). Revised institutional guidance was listed as
“somewhat concerned” by 31% (10/32), and “very concerned” by 31% (10/32).
Requirement for College of American Pathologists (CAP) certification was chosen as
“very concerned” by 31% (10/32).
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Respondents were provided with four responses to choose from for each element: “not a
concern”, “somewhat concerned”, “very concerned”, and “not sure / do not know”.
Biorepository and Biospecimen Research Branch (NIH – BBRB) certification 28% (9/32)
were “very concerned”. Requirement for Clinical Laboratory Improvement Amendment
(CLIA) certification 28% (9/32) were “very concerned”. Respondents were provided
with an open-ended text field and asked to provide examples if they chose “other”.
“Other” was only chosen by 4 people and was picked as “very concerned” by 25% (1/4)
and “not sure / do not know” by 75% (3/4). No text was entered in the text box
associated with selecting the “other” option.
Table 14: Concerns of Respondents Regarding Future Biobank Continuity (N=32)
Item
Not a
concern
Somewhat
a concern
Very
concerned
Do not
know
Mandated continuity of operations
19%
(6/31)
42%
(13/31)
19%
(6/31)
19%
(6/31)
Definition of sharing / ownership rights
28%
(9/32)
34%
(11/32)
25%
(8/32)
13%
(4/32)
International regulations
28%
(9/32)
41%
(13/32)
19%
(6/32)
13%
(4/32)
Revised federal guidance
19%
(6/32)
28%
(9/32)
44%
(14/32)
9%
(3/32)
Revised institutional guidance
28%
(9/32)
31%
(10/32)
31%
(10/32)
9%
(3/32)
Cooperative group / federated biobanking
25%
(8/32)
38%
(12/32)
19%
(6/32)
19%
(6/32)
Virtual biobanking
34%
(11/32)
25%
(8/32)
19%
(6/32)
22%
(7/32)
Biorepositories and Biospecimen
Research Branch (NIH - BBRB)
certification
38%
(12/32)
16%
(5/32)
28%
(9/32)
19%
(6/32)
Requirement for College of American
Pathologists (CAP) certification
41%
(13/32)
13%
(4/32)
31%
(10/32)
16%
(5/32)
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Item
Not a
concern
Somewhat
a concern
Very
concerned
Do not
know
Requirement for Clinical Laboratory
Improvement Amendment (CLIA)
certification
31%
(10/32)
22%
(7/32)
28%
(9/32)
19%
(6/32)
Other
0% 0%
25%
(1/4)
75%
(3/4)
Figure 32: Future Elements of Concern for Biobank Continuity (N=32)
19%
42%
19%
19%
28%
34%
25%
13%
28%
41%
19%
13%
19%
28%
44%
9%
28%
31%
31%
9%
25%
38%
19%
19%
34%
25%
19%
22%
38%
16%
28%
19%
41%
13%
31%
16%
31%
22%
28%
19%
0%
0%
25%
75%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Not a Concern Somewhat Concerned Very Concerned Do Not Know
What do you consider to be future elements of concern for biobank continuity of
operations?
Mandated Continuity Sharing / Ownership International Regulations
Revised Federal Revised Institutional COOP Group / Federated
Virtual Biobanking BBBRB Certification CAP Requirement
CLIA Requirement Other
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Continuity plans should be attuned to the needs and local context of a biobank in order to
ensure that personnel, specimens, data, and physical space are protected from harm no
matter the hazard faced by the biobank. Upon completion of the survey, 57% of
respondents had shared comments to help shed light on their overall experience in
implementing their continuity plans. Approximately 38% provided comments regarding
research and development and 19% provided comments related to installation and
implementation phases of continuity planning. A total of 16 respondents provided words
of wisdom or additional insights; including comments like “after being exposed to this
survey, I will start developing a plan”; “utilization of specimens is key”; “…there are
many regulatory and compliance issues that are involved and [you] cannot just make a
‘business decision’”; “there is no need to recreate the wheel – there are many resources
available to help in developing operation plans”; and “complicated, time consuming and
not infallible…based on financial considerations (which is problematic) and options
(which are limited)”.
4.6 Other Analyses
Cross-tabulations were performed to investigate whether certain demographic features or
answers to certain types of questions would correlate with patterns in other answers to
other questions. Typically, the small numbers of subjects in this exploratory study did
not allow for subtle patterns to emerge. However, certain types of cross-tabulation below
gives an indication of areas in which further exploration might be warranted.
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4.6.1 Cross-Tabulation of Demographic Factors
Because the size of a biobank may affect the way that it approaches operations and
implementations, it was considered important to evaluate the influence of biobank size on
the respondent characteristics and responses. By cross-tabulating the type of biobank with
the number of years for which the respondent was employed, it was apparent that
experienced respondents were distributed across all types of biobanks. Non- profit
biobanks appeared to have fewer long-term employees but numbers are too small for
robust statistical conclusions (Table 15).
Table 15: Cross-Tabulation of Facility Type and Years of Experience (N=45)
I work for a…
Government
facility
Academic
center
Non-
profit
private
company
For-profit
private
company
Other Total
I have been
working in
biobanking
for…
0-2 years
0 3 3 1 0
7
3-5 years
0 7 4 2 0
13
>6 years
1 10 5 7 2
25
Total 1 20 12 10 2
45
The next cross-tabulation (Table 16) was generated to examine the association between
the location of the biobank in an area prone to natural disasters and whether it had a
continuity of operations plan. A location in an area prone to natural disasters was not
strongly correlated with the likelihood that a continuity plan would be in place.
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Table 16: Cross-Tabulation of Natural Disasters and Continuity Plan (N=45)
Is your biobank located in an
area prone to natural disasters?
Yes No
Total
Does your biobank have a
continuity of operations plan?
Yes 13 22
35
No 0 3
3
I do not know 3 4
7
Total 16 29
45
4.6.2 Cross-Tabulation of Evaluation Phase
The type of facility in which an individual works for may correlate with the formal
process that exists to promote improvements to continuity of operations planning (Table
17). Numbers are small, but it might appear that companies in the business of biobanking
have employees with less familiarity with biobank continuity planning.
Table 17: Cross-Tabulation Facility Type and Formal Improvements (N=32)
I work for a…
Government
facility
Academic
center
Non-
profit
private
company
For-
profit
private
company
Other
Total
Does your
biobank
continuity of
operations plan
have a formal
process to
promote
improvements?
Yes… but only
when thought
to be needed
0 3 1 1 0
5
No 0 2 3 0 0
5
Yes, and
scheduled at
least yearly
1 6 0 3 2
12
Other 0 2 1 0 0
3
Do not know 0 2 3 2 0
7
Total 1 15 8 6 2
32
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CHAPTER 5. DISCUSSION
5.1 Overview
An escalating challenge for organizations in the 21st century will be that of responding to
disasters – terrorist attacks, wars, tsunamis, hurricanes, and outbreaks of pandemic
disease (Donahue & Tuohy 2006). These hazards drive scientists from many disciplines
to consider what is known and what needs to be known to facilitate effective continuity
planning. The purpose of this dissertation was to explore the ways in which biobanks
have been approaching and incorporating continuity planning into their operations, given
the limited availability of regulatory guidance. The review of the literature, presented in
Chapter 2, identified what continuity planning meant and how it interfaced with current
biobank practices. To explore this relationship further, it was important to identify an
approach that could be used to systematize the study of ways in which biobanks have
operationalized continuity. The use of an implementation framework (Fixsen et al.,
2013; Fixsen & Blase, 1993) helped the research to move forward with a clear structure
to explore how biobanks were (or were not) incorporating strategies to assure continuity.
By focusing on the staging and drivers of implementation it became easier to identify
areas of commonality with respect to the challenges that must be faced and the elements
that might be incorporated to improve the plans.
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5.2 Methodological Considerations
5.2.1 Delimitations
A key delimitation of this survey research was its restriction to the consideration of
continuity implementation. This relatively narrow scope was regarded as important
because continuity management is so vital to biobank survival, yet so under-described in
academic and policy literature. This study was further delimited to biobanks in the
United States. This delimitation was considered important to provide a more
homogeneous sample of individuals experiencing similar or shared legal, ethical, and
social realities (Cadigan, 2013; Chadwick, 2015; Demeritt, 2015; James, 2003).
Different countries, regions, and states have different structures of health care systems
and varied regulations related to human subject research. Thus, a mix of drivers and
implementation mechanisms will be at play in any locale, but by keeping the focus on the
United States, at least there is some assurance that all the sites work under consistent
federal regulations.
The approach used to frame this study constitutes a unique way of evaluating continuity
planning by focusing on challenges across the implementation life-cycle. This approach
is not intended to assess implementation of the plan at an operational level. For example,
the implementation analysis approach explores whether a continuity plan is supported by
appropriate training of relevant staff based upon existing SOPs, but it does not assess
how these trained staff members utilize their training.
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5.2.2 Limitations
5.2.2.1 Respondent Participation
In any survey study, the numbers and representativeness of the respondents can affect the
validity of the findings. A larger and more representative sampling of respondents will
be more likely to reflect the experience and views of the population that the sampling is
intended to represent, but logistical challenges can limit the recruitment of a large
respondent pool. This challenge is especially relevant in the current study, because the
overall numbers of biobanks are not large, their current operational status cannot be
verified easily, and their staff can be difficult to identify and contact. Thus, it is critical
to consider whether the survey has reached the point of saturation, the point where no
new insight appears to be gained by adding additional participants (Glaser & Strauss,
1967/2009). No fixed sizes or standard test tables can be used to determine when
adequate saturation has been achieved. Rather, the sufficiency of the sample must be
judged on a case-by-case basis, because some populations can have substrata of
individuals with differing backgrounds or opinions, and in these cases more individuals
may need to be recruited (Angrosino, 2006). However, as a benchmark, most studies in
social science research have found that a saturation point can be achieved after a
relatively homogeneous population of 15 to 30 respondents has been tested (Bernard,
2011; Glaser, 1967/2009).
In this study, efforts were made to sample primarily from academically-based biobanks
because they have historically been underfunded and appear highly variable in their
processes and procedures (Henderson et al, 2013a). However, it seemed interesting to
143
explore whether academic biobanks differed in some critical way from privately or
publicly funded biobanks. Thus, a smaller group of respondents were also recruited from
private and public facilities to provide a broader perspective of how continuity planning
is being implemented. The predominant representation of academic organizations may
skew the results of the survey because some literature exists to suggest that the groups
may differ in certain respects. For example, Henderson and colleagues (2013a) noted
that investigator-initiated biobanks and industry-sponsored biobanks had different
approaches to standardized procedures, reporting, and even collection / storage protocols.
Thus, results must be interpreted carefully because the nature of the respondent
population could have generated results that are not representative of either group
individually. Nevertheless, Henderson and colleagues (2013b) also acknowledged that
planning for “when bad things happen” must be a core objective for every type of
repository. Thus, it seems safe to assume that the group of survey respondents solicited
here, which included 57 participants from approximately 49 separate organizations, were
at least moderately representative of the larger population of biobank administrators
within the United States. This may in part explain why cross-tabulations that attempted
to stratify the answers of respondents from different types of biobanks did not reveal any
obvious differences between those in academic versus non-academic biobanks.
A different approach to the subjective measure of saturation to determine the adequacy of
a respondent pool is to consider quantitative measures such as response rate, completion
rate or response numbers (Bernard, 2011). The 57 respondents in this study represented a
response rate of 42%, well above the rates of 10-15% often typical for electronically-
144
disseminated surveys (Sauermann, 2013). Further the completion rate of 91% in this
study compares favorably to recent completion survey rates reported by Hardigan and his
coworkers (Hardigan, Popovici, & Carvajal, 2016). They found that completion rates
diminished with survey length; a 10-question survey had a completion rate on average of
89%, a 20-question survey of 87%, and a 30-question survey of 85%. Because busy
professionals are reluctant to participate in a survey, especially if it is lengthy or difficult
to understand or navigate, most survey experts suggest that completion times be kept to
10 minutes for general populations and 15 minutes for professional groups or selected
panels of experts (Moy & Murphy, 2016; Sauermann & Roach, 2013). The importance
of limiting time-to-completion was reinforced by feedback from the survey focus group
who recommended that the required time to complete the survey should be limited to 15
minutes or less.
Because survey length must be limited, a key concern during the construction of the
survey instrument became the appropriate selection of questions. It is not possible to
capture the full range of respondents’ opinions and experiences with biobank continuity
implementation in a 24-question survey. Further the need to use easily answered
questions in categorical formats can limit the depth and color of responses (Moy, 2016).
Respondents who did not answer some questions, particularly questions later in the
survey, or who aborted the survey altogether before finishing may be exhibiting survey
fatigue, a well-known challenge in which respondents lose interest or feel overwhelmed
by survey questions (Moy, 2016). Nonetheless, it did not appear that this was a
significant concern in this study. Participation may also be limited by the timing of a
145
survey. The timing of the survey, a few weeks into the New Year, may have conflicted
with other activities typical for that post-holiday period, including activities related to the
beginning of the financial year for some organizations or grant deadlines for others
(Holbrook et al, 2008). However, the response rate was not seen as a serious factor
limiting the collection of a relatively rich and consistent dataset.
5.2.2.2 Use of Survey Methods
Diverse methods in research can be directed toward a single research problem. Because
so little is yet known about continuity practices in biobanks, a broadly based exploratory
study based on a well-accepted implementation framework was felt to be a good
beginning point to explore continuity planning across a variety of biobanking
organizations of different sizes and capabilities. Using survey methods, data could be
collected on phenomena that were not directly observable, such as opinions and
perceptions on continuity planning. Further, the anonymous nature and broader reach of
surveys are more appropriate to assess attitudes and gauge characteristics from a broadly-
based group of individuals (Majchrzak & Markus, 2013). Other research methods were
considered, including the use of structured interviews or cases studies, for example.
However, these more focused methods work best when the research questions probe
more deeply, usually after the exploratory studies are first done. These alternative
methods typically require longer time commitments to obtain results; in the field of
anthropology the minimum amount of time required is one year (Agar, 1996; Angrosino,
2006; Bernard, 2011). They also can be more difficult to interpret because they require
146
more subjective content analysis and management of investigator bias (Sauermann &
Roach, 2013).
Survey methods based on electronic distribution can have some obvious benefits,
including cost savings, ease of editing and statistical analysis, fast delivery, higher
numbers of engaged participants, and more candid responses (Sauermann & Roach,
2013). However, they can also raise concerns that could limit the validity of the results.
Some common critiques of electronic surveys include concerns about demographic
limitations or distortions. Additionally, those using surveys must be careful to manage
other issues related to confidentiality, formatting challenges, technical problems and
ambiguity in the questions or instructions. (Moy & Murphy, 2016). Surveys are often
limited in their effectiveness to judge more subjective issues such as feelings; these are
not often captured fully when responses are aggregated into discrete categories of "agree /
disagree," "support / oppose," or "like / dislike" (Wells et al., 2014). Further the self-
report measures typically used for the survey can have inherent limitations, including
distortions of recall and lack of objectivity (Moy & Murphy, 2016). With these
limitations in mind, however, self-report measures still have value in conveying
individual perceptions of their lived experiences, especially when the topic is important
to the participant. In this study, the author received several emails, thank you notes and
requests to see the output of the survey (unpublished observations). These efforts to
connect suggested that there was a genuine interest of many respondents in the topics
explored here, and might further suggest that answers to the survey questions were
considered thoughtfully by at least some of the respondents.
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5.3 Consideration of Results
Continuity planning for biobanks requires a thoughtful strategy to maintain the biobank
in an operational state by assessing and mitigating potential risks. Continuity planning is
not a mandated requirement for biobanks in the United States, yet the majority of
biobanks appear from the results presented here to recognize that such planning is
important. Further, most have a continuity plan. Less than 25% of the sample reported
that they had no continuity plan or, more commonly, did not know if their biobank had a
continuity plan. Most respondents in this latter group were found to work in biobanks no
older than 2 years. It was not clear whether the biobanks with which these respondents
are associated are exploring the option of creating a plan but have not yet advanced that
plan to later implementation stages.
The relative maturity of continuity planning in a majority of biobanks offers the
opportunity to examine challenges presented by that activity at different stages of
implementation. By examining the data through the lens of an implementation
framework, differences in maturity could be characterized by using specific criteria and a
defined vocabulary. This was not to say that organizations always fell cleanly into a
singular stage. Even though the stages of implementation are characterized theoretically
as separate modules, from exploration and adoption of a plan to installation and
improvement, in practice these stages can overlap (Bertram, 2011; Bertram, 2015).
Further, elements of one phase, potentially considered resolved, may later need to be
reexplored and incorporated into SOPs when new risks are identified (Zhang, 2013;
Zhang, 2014).
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5.3.1 Early Stages of Implementation: Exploration
In the framework of Fixsen, the “exploration” phase of implementation determines the
feasibility of a particular program, project, or innovation in meeting an organization’s
needs. At this stage, for example, biobank personnel might assess the risks of certain
types of disasters and estimate the research impact, financial costs, and reputation losses
that such events could potentially incur (Gee et al., 2015). Those activities might involve
consulting with stakeholders and departmental champions, assembling a strategic
implementation team, and identifying implementation goals. All of these activities have
been highlighted in the previous literature as areas that can cause problems for some
teams (Henderson, 2013a).
Two of the challenges identified in previous research as significant areas of concern
during the exploration phase of continuity planning were: 1) poor agreement among
stakeholders on strategic issues that impact group success (Colledge et al., 2014; Lim,
2014; Mayol-Heath, Keck, & Woo, 2011); and, 2) failure to articulate the mission and
adequately identify the goals that constitute the core values of the group (Mische &
Wilkerson, 2016; Uzarski et al., 2015; Vaught et al., 2011). Biobanks often have
multiple stakeholders including, but not limited to, physicians, trustees, patients,
administration, and employees (Bledsoe & Grizzle, 2013; Mayol-Heath, Keck, & Woo,
2011; Yassin et al., 2010). Stakeholders can affect or be affected by the organization's
actions, objectives, practices and policies in different ways (Davis, 2014). Colledge and
associates (2014), for example, studied how stakeholders made decisions about the
release of data and specimens in the absence of legal or guideline-based rules to guide
149
their work. They found that some stakeholders and ethics committees had difficulty in
reaching consensus because of conflicting opinions and competing agendas within their
local biobanking enterprises. It was therefore striking to find that most respondents in
this survey did not appear to identify issues related to stakeholder involvement. This
observation may suggest that the respondents are finding ways to form relationships with
stakeholders through communication, appropriate management of their expectations, and
execution of agreed upon objectives (Rowley, 1997).
The second challenge, which presents when the mission and goals of the organization are
not clear, also seemed of modest concern to survey respondents. For most companies, it
is from the mission statement that goals, objectives and strategies are derived (McConnell
& Drennan, 2006). A clearly defined mission statement and goals benefit the
organization by helping employees to make sense of company-wide decisions, changes in
organization of management, and resource allocation (Engwall, 2003; O'Sullivan et al.,
2013). This comes with the hope of lessening resistance to change and de-escalation of
workplace conflicts (Meagher, Ziolek, & Van den Broeck, 2013; Yassin et al., 2010).
Perhaps the survey respondents had already developed clear mission and goal statements
for their biobanks, or were a part of a larger organization where mission and goal
statements were well established. In these cases, biobanks may not have to go through
the exercise of establishing their missions and goals while also undertaking continuity
plan development in tandem.
The challenges that instead were highlighted by the survey respondents during the
exploration phase of implementation were associated with restrictions in resource /
150
staffing allocations, as well as decisions about the size and breadth of their continuity
plans. Both types of challenges are quite understandable. Concerns about financial and
personnel limitations have been echoed elsewhere (Brown, 1989; Carpenter & Clarke,
2014; Catchpoole, 2015; Uzarski et al., 2015). For example, Bertram and colleagues
(2015) discussed the constraints imposed by fiscal and personnel limitations on the
implementation of continuity. The elements that drive implementation must be clarified
during the exploration phase, and often require hard choices about how money will have
to be spent. Thus, resource restrictions are important to identify and understand early
because they can have lasting consequences for the success of later phases (Fixsen et al.,
2013).
Also understandable are findings that planners were challenged by the decisions that they
had to make about the size and the breadth of the plan. Those decisions will ultimately
affect every aspect of subsequent implementation (Bertram, Blase, & Fixsen, 2015).
Further, the scope of the plan can affect the other area of challenge, that of resource
allocation, discussed above; the more extensive the plan, the more expensive its
implementation. Continuity plans have to be broad in scope because a large number of
naturally-occurring and man-made risks are faced by biobank continuity planners
(Mitchell, 2010; Simeon-Dubach, 2013). Further the planners often seem to be working
in an environment where most of the hazards that might potentially befall the biobank
have not yet happened, so it is difficult to learn from direct past experience. This
limitation forces the biobank to do some form of risk analysis to assess the most likely
risks. For example, a common risk for those in areas prone to natural disasters was
151
identified here to be earthquakes. Thus, it would be prudent to plan for earthquakes in
those areas. However, earthquakes are not the only potential type of disaster that could
occur. A singular focus on earthquakes could leave the biobank vulnerable to other types
of devastating events.
An interesting follow-on area to this survey would be the more detailed study of risk
assessment methods used by biobanks, as has been done for other organizations that have
high-reliability requirements such as nuclear reactors or hydro-power stations (Burgherr
& Hirschberg, 2014; Schroer & Modarres, 2013); additional work to aid in the structuring
of risk assessment methods can be found in the theme park and cruise ship construction
fields (Button, 2000; d'Hauteserre, 1999; Vairo, Quagliati, Del Giudice, Barbucci, &
Fabiano, 2017). Survey responses showed that most continuity plans considered a
number of sources of potential risk. It was striking, however, that most plans focused on
physical and natural disasters, which seemed to be viewed as the types of events that
would have immediate and severe ramifications to the successful operation of their
biobank. Crises related to procurement and logistics, inventory control, and budgeting
were only included in the plans of a minority of respondents. Further, just over half of
the plans were reported to include contingencies to deal with personnel crises and
political / economic crises. Thus, the impression was gained that the planning activities
were focused primarily on natural rather than people-based events. This balance may not
be consistent with the known likelihood of certain threats that are recently posing
problems.
152
A notable example of one such threat was reported by Valach (2016), when in February
2016, Hollywood Presbyterian Medical Center was crippled by a cyber-attack. The
incursion froze encrypted patient and laboratory records and took all network and
computer-related functions offline for more than a week. Hospital President and CEO,
Allen Stefanek, declared an internal emergency as staff manually logged registrations and
records on paper and used fax machines to communicate (Chinthapalli, 2017). Despite
the assistance of local police and security experts, the hospital ultimately realized that the
quickest and most efficient way to restore systems and administrative functionality was to
pay the hackers a ransom of around $17,000 (Valach, 2016; Tuttle, 2016).
An additional area that was incorporated into relatively few planning documents of those
surveyed here was that of financial or economic challenge. As discussed in chapter 2, a
common source of biobank closure is financial exigency. Biobanks are resource-
expensive endeavors that often have vulnerabilities associated with funding cycles from
granting or income sources (Brown et al., 2016; Gee et al., 2015; McDonald et al., 2012).
If the enterprise is not adequately funded, staff shortages and problems in acquiring can
compromise specimens or documentation. Results showed that the possibility of biobank
closure was considered by nearly three-quarters of survey respondents, but less than half
of those respondents had incorporated such a closure into their SOPs as an integral
strategy. It would be interesting to explore why this kind of crisis would not be
considered as a key element to be added to the list of continuity threats. Perhaps the
planners feel that such concerns are dealt with through other mechanisms. Alternatively,
153
it might that this type of threat is viewed as one that will not require a large-scale
emergency action, and was considered to be out of scope for their plans.
The specific approaches taken to carry out risk assessment and evaluation were explored
only marginally in this study, but some beginning insights can perhaps be identified. For
example, only about two-thirds of the plans incorporated a mechanism to assess threats,
even though a more formalized approach might help to guide planners who are concerned
about how extensive the disaster plan should be. The use of risk analysis in the
exploration phase would be of interest to study further, in order to answer at least two
questions. First, how do biobank planners prioritize risks that have occurred over those
that have not? As other authors have demonstrated, “when planning, it is easiest to tackle
known local conditions first” (Cook, 2015; Hatton et al., 2016). However, the danger lies
in believing that natural disasters will recur, and will then follow a similar pattern
(Barberi et al., 2008; Berz, 2002; Klein, 2003). However, planning needs the flexibility
to respond to an enormous catalogue of requirements most of which are only imagined
(Alexander, 2005).
A second question, related to the first, is whether risk assessment might be improved by
using certain types of tools for rigorous risk analysis and evaluation. Several risk
management guidances exist. Particularly helpful might be ISO 31000, Risk
management – Principles and guidelines, a well-recognized, global industry standard that
“provides principles, framework and a process for managing risk… by any organization
regardless of its size, activity or sector” (ISO, 2009). It advocates that risks should be
characterized according to severity and likelihood. Why such estimation may be
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important is illustrated by the recent experience of the Svalbard Global Seed Vault. This
Vault is a biobank sunk deep into permafrost of the Norwegian Arctic Circle to serve as
an impregnable deep-freezer that could protect the world’s most precious seeds from any
global disaster. The Vault was seen as a way to ensure humanity’s food supply forever
(Carrington, 2017). It had an extensive continuity plan that focused on a number of
natural and man-made disasters like earthquakes, fire, piracy, and vandalism.
Nevertheless, it failed to assess adequately the threat from one of the most obvious
challenges facing the Arctic, that of global warming. Thus, the Global Seed Vault found
itself in trouble when meltwater from liquefying ice gushed into the facility’s entrance
tunnel and then refroze to plug access to the facility (Carrington, 2017). Complete
damage assessment to the entryway and vault itself will not be completed until the
current plug has been thawed and workers can safely access the facility, but the cleanup
costs alone are estimated to be in the hundreds of thousands of dollars (Carrington, 2017).
Attempts to focus on disasters with a low probability of occurring while failing to pay
attention to those that have a particular likelihood related to local conditions – like
flooding in the case of the Svalbard Vault- is not unusual. It has been recognized in
sectors as diverse as museum planning (Simmons & Keene, 2006), financial asset
management (McCammon et al., 2012; Torres & Marshall, 2015; Webb, Tierney, &
Dahlhamer, 2000), and hospital emergency response settings (Cousineau & Tranquada,
2007; Franco et al., 2006; Osgood et al., 2015). Quarantelli (1988) offered one of the
most concise descriptions of this deficit and concludes that planning is too focused on
one type of crisis in particular, and often fails to consider the similar consequences of
155
various other types of events. Donahue and Tuohy (2006), in discussing the failures
resulting from Hurricane Katrina, indicated that “problems are exacerbated by the fact
that planning processes are typically infrequent, so plans become dated and do not
incorporate lessons from recent events”. When the time comes for implementation of
continuity plans, those on the front lines do not know which problem to address first, and
when disaster occurs, they may not know what is even in their continuity plan (Donahue
& Tuohy, 2006).
Notably, nearly half of the respondents reported that they had no significant challenges
during the exploration phase. This finding was unexpected, given the shortage of
guidance and standards for creating, evaluating, and approving continuity plans
(Alexander, 2005). It was also provocative to find that few appeared to be hindered by
poor cooperation from other departments. Poor cooperation across organizations or
within departments has been an often-highlighted barrier identified in the business
continuity planning and management literature (Cerullo & Cerullo, 2004; Cook, 2015;
Crichton, Ramsay, & Kelly, 2009; Hatton et al., 2016). Even though the need for
cooperation did not seem to be an important challenge, some respondents identified other
methods to promote evaluation and protective measures. Two examples of the measures
that respondents used were: 1) evaluation of physical work space for potential hazards by
over three-fourths of responders; and, 2) evaluation of current processes to determine
“steady state” elements for recovery of operations by over two-thirds of responders.
Of some interest was the finding that roughly a third of respondents professed not to
know whether barriers had hindered the research and development stages of their
156
continuity planning. Why is not clear. It may be that the contingency planning for these
biobanks took place early in the life of the biobank, before the respondent was employed
in that operation. Often, the exploration phase is not revisited if a plan is fairly
comprehensive, although revisiting the plan at regular intervals is considered to be a “best
practice” of policy management during the final phase of implementation called
“sustainability” (Blase & Fixsen, 2013; Fixsen et al., 2013). Lalonde (2011) warns that
managers tend to limit planning to the producing a written plan. Thus, that plan is not
viewed as only the first step in a continuous process. In addition, not all members of the
team may participate in the exploration phase of continuity planning, especially if that
planning is a subcomponent of a larger set of activities put into place for the parent
institution overseeing the biobank.
5.3.2 Intermediate Stages of Implementation: Initial Implementation
Installation begins at the point when the decision is made to move forward with a plan
that has so far existed only as a planning document. It includes a cascade of preparatory
activities needed to implement the new program or innovative practice – developing a
roll-out plan; acquiring financial and human resource assets; finding, reallocating, or
repurposing physical space (if needed); and purchasing equipment and technology (Cook,
2015; Fixsen et al., 2013; Fixsen & Blase, 2009). Results from the survey suggested that
nearly two-thirds of the surveyed biobanks had installed their programs using these
benchmarks. Installation can overlap with initial implementation, a stage characterized
by the development of SOPs and work instructions, the remediation of facilities and the
training of personnel.
157
It can be difficult to evaluate and compare the maturity of installation and initial
implementation across different biobanks, especially when by evaluating facilities and
financial allocation. The need for changes to buildings or other physical structures will
vary considerably from one biobank to another. Some biobanks will not require
significant changes to their facilities whereas others will need substantial remediation,
such as earthquake hardening (Hamburger, 2002). However, all biobanks should be
expected to have standard operating procedures by the end of this phase, so the presence
of SOPs to address issues of disaster planning may be a more consistent indicator of
successful installation. Having SOPs and documentation of business practices, policies,
and procedures is a characteristic of advanced implementation (Bajgoric, 2014; Bertram,
2015; Cohen, 2008; Sahebjamnia, 2015).
Results here suggested that the biobanks of most respondents had developed SOPs. It is
to be expected that these will vary significantly as biobanks incorporate specific elements
into their continuity frameworks depending upon their physical location, experience, and
identified needs. However, points of commonality between disaster scenarios can help
planners to use comparable approaches to forecast events and anticipate consequences
(Alexander, 2005). Thus, it is likely that certain common features should be included in
those procedures. An obvious SOP for disaster management would seem to be that for
evacuating employees, a sine qua non of disaster planning. It was surprising then that at
least one biobank did not have such an evacuation plan. However, evacuation plans were
reported in 93% of the biobanks who reported having SOPs. At least five additional
areas were also addressed in the SOPs of more than three quarters of biobanks, including
158
those to assess threats, to isolate equipment failures, to establish contingency plans for
identified threats, to make decisions in crisis, and to assess best practices. Perhaps these
areas of focus are to be expected considering that most biobanks appeared to use the NCI
BBP as foundational material (NCI, 2014). The NCI BBP as well as most other disaster
planning guidances in this and other sectors identify these areas as important to address
(Mische & Wilkerson, 2016; Simeon-Dubach, Zaayenga, & Henderson, 2013).
More interesting, perhaps, were the elements that appeared to be left out of the SOPs of
some biobanks. For example, less than 45% of the respondents who reported having
SOPs had a mechanism for biobank closure and only 41% had a mechanism to identify
and mitigate administrative barriers. Administrative barriers have been identified in the
literature as an often-impactful problem for program implementation (Bertram, Blase, &
Fixsen, 2015; Schmitt et al., 2015; Sittig, Gonzalez, & Singh, 2014). It may simply
reflect the fact that program designers do not feel that it is appropriate to include the
management of administrative activities in an SOP. It may also be consistent with
reports that administrative barriers were not considered to be an area of challenge during
the planning phase. Most biobanks examined here were relatively small, so their modest
administrative structures may be relatively easy to navigate. Most studies of disaster
planning, such as those for municipalities or large facilities such as nuclear reactors, have
a much larger scope of operations that cut across multiple political, community and
departmental lines (Alexander, 2005).
A vital component of the implementation process is the need to assure that staff are
capable of responding effectively to the disaster. The Fixsen model specifically calls out
159
competency drivers (selection of appropriate staff, training, and coaching) as one way to
improve implementation (Blase & Fixsen, 2013; Fixsen et al., 2013), but training can be
complicated to design. Too little planning can lead to the syndrome of “on the job
training”, an undesirable approach when that training can only take place during a crisis.
However, too much planning risks overwhelming or immobilizing staff, and it can result
in the false assurance that everything is under control (Lalonde, 2011). Regardless of the
approach, one might expect a training gap amongst new employees. Nevertheless,
several respondents, and even respondents with longer tenures than 6 years, appeared to
have a relatively poor understanding of their continuity plans. This finding highlights an
area that could be a target for improvement. It is critical that all staff in a biobank are
familiar with the details of the continuity plan because an immediate response to a
disaster is often needed. The results point to the potential value of evaluating the
effectiveness of current strategies to enrich organizational knowledge (Argote, 2013;
Olsson, 2006), through improved communication and on-going training of biobank staff
(Ager & O’May, 2001). An area for future research would be to analyze the way in
which training is carried out and whether additional resources could be developed to aid
these educational activities.
Another area of evaluation that might deserve attention relates to the finding that many
respondents were not familiar with the NCI BBP, ISO 22301.2012, or FEMA guidance
documents. It is not surprising then that many did not know if these were used in the
development of their plans. It is, perhaps, overkill to train all members of a biobank staff
on the types of guidance documents that can contribute to biobank continuity
160
preparedness. However, it would seem reasonable that those in charge of organizing and
updating the continuity plan would have this knowledge.
5.3.3 Mature Stages of Implementation: Full Implementation
In full implementation, the organizational system has largely been recalibrated to
accommodate and support continuity practices, by solidifying and modifying the
processes and procedures with experience and new information. The survey data gives
strong evidence that many of the surveyed biobanks have some form of continuity plan
and many appear quite mature in their implementation. It is however, not easy from this
survey to know if the implementation plan will be sufficient when needed. Research has
suggested that many plans lack sufficient ongoing implementation strategies to respond
adequately to a crisis (Lalonde, 2011). Prior planning for a disaster can limit difficulties,
but cannot completely eliminate all of them (Quarantelli, 1988). Thus, a tension between
the continuity plan (which constitutes a kind of roadmap) and direct action (which is the
actual road) must be anticipated (Boin & McConnell, 2007). Because so many of the
potential hazards that might pose a threat may never be experienced, it is particularly
difficult to know whether the implementation plan, no matter how mature, will meet the
needs of the biobank when a disaster actually takes place. What does seem clear,
however, both from the literature and from good management practice more generally, is
that the success of a plan is linked to at least two conditions - first, the effort taken to
maintain and update the plan; and, second, training to assure that staff understand and can
carry out their responsibilities according to the plan (Bakar, Yaacob, & Udin, 2015;
Penadés, Núñez, & Canós, 2017).
161
Although it was not possible to examine the specific content of the disaster plan or SOPs,
what was possible was to query the frequency with which the plan was reviewed and
potentially revised. Interestingly, a majority identified that their SOPs included
“mechanisms to incorporate feedback and data to improve planning”. However, the way
that this was handled operationally seemed to fall short of what might be expected of
such a mechanism. For example, slightly less than half identified that their plans were
changed either immediately or within a reasonable period after new risks or information
emerged. Further the fact that relatively few biobanks were revisiting their plans at
regular intervals when conditions changed may suggest that the plans may not be
reconsidered frequently or thoroughly.
Training continues to be a key requirement during full implementation to assure that a
disaster plan can be carried out effectively when necessary. It was surprising that only a
few biobanks appeared to have training related to the continuity plan at the time when
new employees were oriented. Instead, most commonly, the training occurred annually.
It was striking that at least one quarter of the respondents identified that training was
never conducted or did not know if training was conducted. In those biobanks, one must
question whether the contingency plan will be followed during an emergency. It is also
questionable whether such biobanks could be considered as at a stage of full
implementation without such ongoing training. Human resource training and
development is considered by Fixsen and colleagues as a competency implementation
driver (Fixsen et al., 2009).
162
It also continues to be a question whether that training is effective. Three quarters of
respondents identified that training elements included activities such as review of the
written plan, review of the evacuation plan, and review of responsible parties- all
activities that suggest simply the review of documentation. One respondent further
commented that “employee quizzes as part of the biorepository's Annual Competency
Assessment [are] required to maintain our CAP Biorepository Accreditation”. However
only about half indicated that role playing of crisis scenarios was used as a training
technique at orientation and annual training. Perhaps more problematic, respondents
reported that role playing as a training element was often in place only partially. The
work that Penadés and coworkers (2017) carried out corroborate this finding. They
showed that most of the recommendations for emergency plan training were not
sufficiently flexible to allow emergency teams to cope with unexpected changes, making
it difficult for some teams to adapt to the chaotic patterns inherent in emergencies
(Penadés, Núñez, & Canós, 2017; Parry-Jones et al., 2017). Role-play or some form of
simulated event during training would be beneficial, because the unexpected could be
confronted in a safe environment and would make staff more efficient and nimble if, and
when, a crisis should happen.
5.3.4 All Stages of Implementation: Recurring Challenges
The use of an implementation framework with defined stages also assisted the research in
this dissertation by highlighting areas of challenge that appear to occur or recur at
different stages. One notable challenge that appeared to plague not only the installation
phase but later phases as well was that related to limited financial resources. Such an
163
obvious and pervasive problem is not unusual and is predicted from anecdotal writings
elsewhere (Brown, 2016; Gee, 2015; Tierney, 2007). However, other challenges
appeared to be more prevalent to a particular stage of implementation. For example, the
survey data identified that poor cooperation between departments was identified by more
than 50% of respondents in the research phase but dropped to only 20% of respondents
during the development phase. The extent of cooperation can impact how biobanks
function and become embedded as core resources within an organization (Henderson,
Simeon-Dubach, & Albert, 2015). The difference seen in the survey data with regard to
cooperation suggests that coalition building may have occurred during the research phase.
Cooperation across and among departments has been shown in the literature to be
important in areas like communication (Cook, 2015); resource sharing (Alexander, 2005;
Kajikawa, 2008; Mische, 2016); and facilities preparation (Carpenter, 2014; Pitt, 2004).
Communication in the vertical hierarchy can also be important; management often has a
different view of policies, procedures, and workflows than those actually doing the work.
(Church, Hurley, & Warner Burke, 1992). It was perhaps telling that sub-stratification of
the data according to whether the respondent was, or was not, an administrator suggested
that administrators might have stronger concerns related to financial constraints, resource
allocation, and lack of guidance documents. In contrast, individuals in operational roles
appeared to emphasize challenges related burdensome data collection and lack of
cooperation from stakeholders in addition to the ever-present concerns about financial
constraints.
164
5.4 Future Directions and Concluding Thoughts
Biobanking is an evolving area of regulatory interest. What began as small collections of
tissue, often based at academic medical centers and focused on fulfilling specific study
needs, have grown into an emerging biotech industry. This is evident in the publication
of best practice guidelines for biobanks (NCI, 2011; OECD, 2009; ISBER, 2005/2012)
and the establishment of an extensive biobank accreditation program (CAP, 2017).
However, many biobanks still tend to focus on their research goals at the expense of more
standard conventions associated with good business practices, in which it is vital to create
and maintain a sustainable organization (Cadigan et al., 2017; Cadigan et al., 2013). To
assist in the improvement of continuity planning, the following research
recommendations provide five ways research into continuity practices can help expand
our regulatory understanding related to policy, practice, and implementation.
1. This study provides only superficial information about the specific
elements of different plans. It may be advantageous to conduct
research to study specific elements of these plans in greater detail in
order to give better guidance about the elements that should be present
in such plans.
2. This study was focused on biobanks in the United States. A broader,
global survey of biobank continuity planning might provide insight
into differences in other constituencies. This is especially important
in newly emerging economies that are subject to only modest oversight
and regulation.
165
3. This study pointed to a relatively simple, paper-based training
approach in most biobanks. New technologies such as the use of
Microsoft’s HoloLens could allow biobanks to use virtual reality or
augmented reality simulations, in which an existing office layout could
be stressed by a variety of potential hazards. Such a resource could
allow an individual or whole team to train for certain types of
infrequent disasters. The use of 3-D environments and computer
enhanced interfaces to allow people to practice disaster response is not
only cost-effective but could function as a training modality that would
give them experiential knowledge on which to draw should hazardous
events occur in the future.
4. This study suggested that guidance for continuity planning is relatively
high-level and lacking in specifics. Development of practical
guidelines with examples or templates could help continuity planning
teams improve their plans. Areas such as risk assessment, emergency
planning, staff training, monitoring and evaluation techniques, and
stakeholder engagement have little guidance currently, but could profit
from more information and tools. Perhaps a stage-based checklist to
encourage biobanks to consider key items at specific intervals would
be the best way to optimize a disciplined regulatory approach to
continuity while preserving local determination.
166
5. This study suggested that biobanks were developing their plans with
little ongoing input on their scope and effectiveness. Expansion of
third-party Clinical Research Organizations (CROs) to perform
assessments and provide recommendations might be useful to
biobanks as they put into place and update continuity plans
personalized to their local environments. Such organizations would be
cost effective because they would house individuals who are expert in
crisis, continuity, and implementation practices that smaller biobanks
with limited funds could utilize. Additionally, these organizations
could offer training and real-life scenarios to help prepare staff for
future crisis events.
The findings in this study have implications for administrators, funders, regulators, and
researchers especially related to concerns around limited guidance and vague best
practices. When the worst happens, a well thought out and well implemented continuity
plan will protect personnel and collections. Given the uncertainties that surround
disasters, it is critical to develop practices and procedures that allow for efficient
recovery.
167
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APPENDIX A. BIOBANK CONTINUITY SURVEY
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Abstract (if available)
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Asset Metadata
Creator
Church, Terry David
(author)
Core Title
Continuity management in biobank operations: a survey of biobank professionals
School
School of Pharmacy
Degree
Doctor of Regulatory Science
Degree Program
Regulatory Science
Publication Date
10/10/2017
Defense Date
09/15/2017
Publisher
University of Southern California
(original),
University of Southern California. Libraries
(digital)
Tag
best practice,biobank,continuity management,continuity planning,crisis planning,disaster management,guidance document,implementation,OAI-PMH Harvest,regulation,stage of implementation
Language
English
Contributor
Electronically uploaded by the author
(provenance)
Advisor
Richmond, Frances J. (
committee chair
), Jamieson, Michael (
committee member
), Martin, Sue Ellen (
committee member
), Rodgers, Kathleen (
committee member
)
Creator Email
tdchurch@usc.edu,terry.church@med.usc.edu
Permanent Link (DOI)
https://doi.org/10.25549/usctheses-c40-444613
Unique identifier
UC11264012
Identifier
etd-ChurchTerr-5835.pdf (filename),usctheses-c40-444613 (legacy record id)
Legacy Identifier
etd-ChurchTerr-5835.pdf
Dmrecord
444613
Document Type
Dissertation
Rights
Church, Terry David
Type
texts
Source
University of Southern California
(contributing entity),
University of Southern California Dissertations and Theses
(collection)
Access Conditions
The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...
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Tags
best practice
biobank
continuity management
continuity planning
crisis planning
disaster management
guidance document
implementation
regulation
stage of implementation