Biobank Continuity Management: A Survey of Biobank Professionals

Abstract

Academic biobanks face challenges that call for continuity and disaster planning. However, current regulations do not require such planning, so it is unclear if and how biobanks have prepared themselves to deal with future crises. This exploratory study used mixed methods to understand the state of continuity planning in U.S. biobanks. It 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 biobanking. 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 6 years and these typically had some form of continuity plan in place. More commonly, continuity planning was reported to be focused on countering natural disasters rather than organization- or personnel-related crises. Respondents identified their most common limitation to be financial resources affecting all phases of implementation. Although many respondents appeared to be aware of some guidance documents and standards for continuity planning, many reported that they did not use or reference them when constructing their biobank continuity plans. Furthermore, nearly 25% of surveyed biobanks did not have a continuity plan and 61% indicated concern in having a mandated continuity plan. Results suggested academic organizations would benefit from a continuity plan template and best practice guidelines for plan development and implementation.

Introduction

Biobanks face challenges to continuity. Much has been written about vulnerabilities related to logistical or regulatory issues—management of informed consent or patient confidentiality, for example—that can present day-to-day management of challenges.^1,2 Their survival can also be compromised by the vagaries of funding, employee transitions, expertise, and leadership.³ However, the art of sustaining a biobank includes also its ability to anticipate and respond appropriately to longer-term disasters.⁴

Recent environmental events—hurricanes, tsunamis, earthquakes, and snow storms, for example—have highlighted the vulnerability of biobanks to disaster. Undesirable human intrusions or interventions—power outages, workplace invasions, weaponized assaults, computer hacking, data falsification, intended and unintended release of confidential information, theft of products, or the demands for the ransom of stolen data—can also damage individual businesses or compound ongoing and concurrent disasters.^5–8 Unmanaged, they can result in loss of revenue, reputation, information, access to facilities, specimens, and personnel.^9,10

Systematic plans for continuity are hard to develop and implement. Although formalized approaches for other industries have been available for more than 50 years (see Church⁴ for review), specific guidance for biobank continuity in the United States was not available until late in the 20th century,^11–13 mostly as best practice guidance documents. Their high-level recommendations suggest that biobanks should assess and protect operational activities relating to quality control, security measures, and storage standards.¹⁴

Perhaps the most comprehensive is that from the National Cancer Institute's (NCI) Biorepositories and Biospecimen Research Branch.¹⁵ It sets a minimum acceptable operational methodology for the “technical, operational, ethical, legal, and policy best practices to ensure a level of consistency and standardization across biospecimen resources,”¹⁵ including high-level directions on establishing and maintaining a biobank and its biospecimens. This general blueprint is instructive for developing a stable operational state, but does not provide process nor implementation methodologies to assist biobanks in the management of their collections. Thus, each biobank appears left to develop its own terms and practices.

A few other federal and international guidance documents discuss certain narrow sets of disasters and man-made crises for which planning would be expected,^16–20 but most do not offer systematic ways to approach continuity across different lifecycle stages or geographic locations. For example, little has been required in terms of risk analysis and risk management, cornerstones of continuity management in other industries. The literature more generally fails to elaborate more on practical approaches to biobank continuity plans. An example of a recent article that provided a very general outline of a business plan for biobanks included a recommendation that biobanks consider contingency planning.²¹ In particular, this article highlighted threats that impact economic sustainability like loss of funding, closure of host institution, or massive withdrawals of consent, but did not provide ideas about how to plan for or recovery from these setbacks.²¹ Furthermore, little is known about the nature and adequacy of the approaches and practices already in use by biobank administrators when planning for long-term continuity. Thus, the purpose of this study was to explore the ways in which biobanks have assessed and implemented programs to assure their operational continuity in the absence of formalized requirements.

Materials and Methods

This study relied on a structured 30 question electronic survey instrument to obtain information related to continuity practices of U.S. biobanks. The survey was built and disseminated using a web-based survey platform (Qualtrics™ Insights Platform). Questions were organized by reference to the implementation model of Fixsen et al.²² that divides implementation into sequential phases. Questions were grouped into three collections related to biobank continuity planning: (1) demographics and general biobank information; (2) elements that explored the maturity of implementation; and (3) elements that explored the state and importance of different implementation drivers.

The survey was critiqued to improve its face validity by a focus group of six expert biobanking professionals and six academic researchers experienced in survey methodologies. Potential respondents were identified from networks of individuals who participated in biobank research as reflected in university websites and documents, professional conferences, training seminars, professional organizations, and personal networks. A total of 175 potential respondents were invited to participate in the survey, of whom 57 completed the online survey. The survey was activated and deployed from January to February 2017.

The definition we chose to use for continuity planning was the set of activities designed to guard business practices by protecting or recovering precrisis operations of key activities. For biobanks, we extended this definition to refer to the ability to maintain biobank operations throughout an often complicated life cycle of institutional change regardless of internal or external distress.

Results

Continuity planning activities cover a wide range of topics with the ultimate goal of long-term sustainability. The data presented herein cover a few small portions of continuity planning and relate to crisis management, disaster recovery, and overall administrative plan management to highlight areas of need across biobanks in the United States.

Demographics

Respondents were associated with academic centers (44%), nonprofit private companies (27%), for-profit private companies (22%), government facilities (2%), and a hybrid environment (4%) defined as “Non-Profit Public Organization” and “For-Profit Private/Governmental Alliance.” The survey respondents included a few individuals who were new to biobanking [0–2 years (16%)], but most were quite experienced [3–5 years (29%), >6 years (56%)]. The job functions of the respondents included administrative (67%) or technical (22%) roles and roles described as “other” (11%), further identified as dual “administrative and operational,” “co-director,” and “faculty oversight.” Most of the respondents (82%) worked for biobanks in operation for >6 years. Biobanks ranged from small biobanks employing “ < 10 people” (51%) to medium and large biobanks defined arbitrarily as those employing “11–49 people” (31%) and “ > 50 people” (18%), respectively.

Development and Implementation of continuity plans

Most respondents (78%) identified that their biobank had a continuity plan. More than half of the plans had been in place for “>6 Years” (56%); the others had been developed either within “0–2 Years” (25%) or “3–5 Years” (19%). A few indicated that they had no continuity plan (7%), and a higher number did not know (15%) whether their biobank had a continuity plan. Most plans were prepared for physical crises and natural disasters, but many fewer addressed human-based threats such as information theft or ransom, political, economic, or reputational crises, or staffing disruptions (Table 1). Earthquakes (67%), floods (64%), tornadoes (43%), and hurricanes (40%) were ranked as most likely threats in the geographic areas of respondents. Biobanks had most commonly experienced earthquakes (36%), snow emergencies, and hurricanes (20%). Seldom or not considered were tsunamis (93%), landslides/mudslides (93%), and volcanic activity (93%), even when a particular geographic area was prone to that type of disaster (Fig. 1). “Other” identified challenges were “power outages” and “drought.”

FIG. 1.

Local natural disasters identified (N = 32). Disaster exists, disaster experienced, and disaster not considered. Note: Disaster exists stands for the potential for the natural disaster to occur in the respondent's geographic area. Disaster experienced indicates that the respondent's biobank has experienced the natural disaster. Disaster not considered includes those disasters that may occur in the respondent's geographic area; however, their continuity plan does not have a specific action plan for the event listed. Other was a “please specify” field and returned the following responses: “drought” and “power outage.”

Table 1.

Biobank Continuity of Operation Plan Elements (N = 32)

Item	Considered and incorporated	Considered, Not incorporated	Not considered	Do not know
Physical crises (e.g., accidents, equipment failure, and loss of power)	84%	6%	0%	9%
Natural disasters (e.g., volcanic eruptions, earthquakes, and floods)	69%	13%	9%	9%
External agent crises (e.g., terrorism, product tampering, cybercrime, information theft, and information ransom)	41%	16%	28%	16%
Reputation crises^a (e.g., internet defamation, malicious rumors, and false accusations)	39%	16%	32%	13%
Personnel crises (e.g., criminal actions, large-scale illness, large-scale death, and disgruntled employee)	31%	34%	22%	13%
Political/economic crises (e.g., change in government, change in institutional leadership, change in funding, business failure, and accounting problems)	22%	34%	28%	16%
Other crises	0%	0%	25%	75%

This question was answered by 31 respondents.

All respondents identified that both the planning and implementation of the plan were challenged by limited financial resources and with few exceptions, limited personnel resources (Table 2). They also were challenged when setting the scope and depth of the plan. However, a number of other challenges were experienced, although less commonly, as shown in Table 2. The lowest of the reported challenges, acknowledged by 20%–40% of respondents, were poor cooperation among departments in the developmental phase and slow oversight committee review in the investigational phase, respectively.

Table 2.

Challenges During Continuity Plan Creation (N = 15)

Challenge encountered	Investigation phase		Development phase
Challenge encountered	Yes	No	Yes	No
Information technologies challenges	60%	40%	50%	50%
Poor cooperation from other departments	60%	40%	20%	80%
Unable to agree on size/extent of plan	80%	20%	80%	20%
Burdensome data collection/research	50%	50%	80%	20%
Failure of institutional leadership	50%	50%	60%	40%
Slow scientific or ethical review board approval	40%	60%	60%	40%
Resistance from biobank stakeholders	60%	40%	60%	40%
Limited financial resources	100%	0%	100%	0%
Limited personnel resources	100%	0%	80%	20%
Resistance to change	60%	40%	60%	40%
Lack of federal, institutional, or local guidance	60%	40%	80%	20%
Attempting to evaluate every potential hazard	100%	0%	60%	40%

When preparing their plans, most respondents were familiar with the NCI Biorepository Best Practices (79%); the Health Insurance Portability and Accountability Act requirements (74%); and the International Society for Biological and Environmental Repositories best practices (72%). Half were aware of preexisting institutional plans (50%) and only a minority were aware of the Federal Emergency Management Agency continuity planning strategies (37%); the International Organization for Standardization (ISO) 22301:2012 Societal Security's—Business Continuity Management Systems—Requirements (35%)*; or the Pandemic and All Hazards Preparedness Act documents (24%) (Fig. 2).

FIG. 2.

Incorporation of guidance documents into continuity plans (N = 29). Aware of guidance and not aware of guidance. FEMA, Federal Emergency Management Agency; HIPAA, Health Insurance Portability and Accountability Act; ISBER, International Society for Biological and Environmental Repositories; ISO, International Organization for Standardization; NCI, National Cancer Institute; PAHP, Pandemic and All Hazards Preparedness Act.

Ongoing continuity planning and practice

Most biobank continuity plans appear to be updated at regular intervals, some when new risks are identified (44%) and others every 12 months. Major changes to plans appeared to, primarily, correspond with risk assessment/vulnerability reports from information technology (28%) and structural assessments of physical space from facilities management (26%). Some events such as changes in institutional policies or requirements (25%) and government guidance (26%) triggered a review and update, typically within 30 days. A few had never updated key sections of their continuity plans (Fig. 3) and an average of 21% did not know how often different aspects of their continuity plans were updated in relation to diverse initiating factors. All reported that staff were engaged in reviewing, and many were held accountable for the ongoing plan (Fig. 4). Several biobanks, however, had no plans for role-playing/practice performance of processes and procedures, and some had no provision for annual reviews or tests with staff.

FIG. 3.

Frequency of continuity plan updates (N = 32). Immediate update, update every 6 months (immediate defined as within 30 days), update every 12 months, update informally, never update, and do not know. Note: Frequency with which biobanks change their continuity plans based on diverse initiating factors. The text highlights the most common approach. On average, 21% answered, “Do not know.”

FIG. 4.

Life cycle development for continuity plans (N = 27). In place, partially in place, and not in place.

Future considerations related to biobank continuity planning

Respondents had differing views on certain factors that might affect their continuity planning in the future. Almost three-fourths were either very or somewhat concerned that federal guidance documents would be revised (72%), yet just over a quarter were not concerned (28%). Respondents were often also concerned about the possibility that continuity of operations documents would become mandated (61%). Other common concerns included mandated participation in cooperative groups/federated biobanking to obtain National Institutes of Health (NIH) funding (57%), changes in the formal definition of sharing/ownership rights to specimens (59%), and the introduction of international regulations (60%). In comparison, many more respondents viewed virtual biobanking (34%), NIH biorepositories and biospecimen certification (38%), College of American Pathologists (CAP) certification (41%), or Clinical Laboratory Improvement Amendment certification (31%) as areas of low concern (Table 3).

Table 3.

Future Areas of Concern for Biobanking (N = 32)

	Very concerned	Somewhat concerned	Not a concern	Do not know
Requirement for CLIA certification	28%	22%	31%	19%
Requirement for CAP certification	31%	13%	41%	15%
Requirement for NIH BBRB certification	28%	16%	38%	19%
Virtual biobanking for shared data	19%	25%	34%	22%
Cooperative group/federated biobanking mandatory participation for NIH funding	19%	38%	25%	22%
Revised institutional guidance	31%	31%	28%	9%
Revised federal guidance	44%	28%	19%	9%
Implementation of international regulations	19%	41%	28%	13%
Changes in definition of sharing/ownership rights for specimens	28%	34%	28%	13%
Federally mandated continuity of operations	19%	42%	19%	19%

BBRB, Biorepositories and Biospecimen Research Branch; CAP, College of American Pathologists; CLIA, Clinical Laboratory Improvement Amendment; NIH, National Institutes of Health.

Discussion

Continuity planning is not a mandated requirement for U.S. biobanks, yet these results suggest that most biobanks have some form of a plan. Those plans appear challenging to develop and maintain. One of the clearest challenges, limitations on financial resources, was predicted from anecdotal writings elsewhere.^14,23–27 Others appeared to be associated with specific stages of implementation. For example, poor cooperation between departments, identified more frequently during the research than the development phase, might suggest that coalition building is difficult in early stages, but may resolve over time with experience and trust in key areas such as communication, resource sharing, and facilities preparation. Many also appeared to differ greatly with regard to the nature of staff training, the frequency of plan revision and update, and the accountability for plan maintenance. Such differences may not be surprising given the fact that templates and guidance related to the logistics of continuity plans are not available. What was perhaps more surprising was the finding that about one-quarter of biobanks had no plan or did not know of a plan. This vulnerability brings into question whether and how much continuity planning should be required. Requirements for any type of new activities can be useful, but have unintended consequences. If regulators were to implement more rules and oversight, costs for these biobanks would escalate, yet resource limitations are perhaps the biggest challenges faced already by many types of repositories. It is perhaps then quite understandable that most biobanks were concerned about revisions or mandates to federal or professional association recommendations for requirements associated with biobank planning. Recently, the ISO has published a general requirement standard related to biobank operations, which has little information regarding continuity beyond the recommendation that a formalized disaster plan for storage failure be in place.²⁸ Other standards suggested by this ISO general requirement may impact biobank operations in terms of data management, specimen tracking, and specimen depletion.²⁸

Continuity plans are recognized by most as being important, but can prove to be challenging for some biobanks to accomplish. The data collected in this survey illuminate some challenges, but could not evaluate the quality of the existing plans and whether improvements are needed. Those biobanks without a continuity plan face the toughest hurdles in terms of implementation as they attempt to develop a plan without templates or step-wise guidance to assist them. However, the biobanks with no plan or less developed plans were typically smaller and younger biobanks that have the greatest need in terms of support, as many may not be aware of national or international guidance documents. A cottage industry is growing to assist with “risk assessment for designing or redesigning the business continuity plan,”²⁹ but such services might be cost prohibitive and might tend to overburden academic biobanks with unnecessary procedures. These biobanks would benefit from guidance documents and templates that are scalable and account for economic constraint, size, collection type, and research utility.

The findings in this study have implications for administrators, funders, regulators, and researchers especially related to concerns around limited guidance and vague best practices. There exists a reasonable template for crisis management for biobanks,³⁰ but this is just one component of a solid continuity plan. Many of the biobanks surveyed showed concern about the expansion of oversight in regard to continuity planning, but were more enthusiastic about the benefits that access to templates and guidance documents might provide. These documents should allow for scalability and provide recommendations that would be appropriate for banks of all sizes and collection types. An organization such as the CAP who offer certification programs for clinical biobanks could be used as a model to help develop and make publicly available general templates for implementing continuity plans for academic centers and nonprofit organizations. These plans could be informed by the clinical biobank certification process and draw from the diversity of biobank sizes, utilities, and needs to create guidance documents that take economies of scale into account. As history has shown, 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 and long-term sustainability.

Footnotes

Acknowledgments

We thank our colleagues from the University of Southern California, School of Pharmacy, Department of Regulatory and Quality Sciences, who provided insight and expertise that greatly assisted the research, although they may not all be in agreement with the interpretations/conclusions of this article. We thank Sue Ellen Martin, MD; Associate Chief of Anatomic Pathology, Keck Medical Center of USC and Norris Cancer Center Hospital; and Nancy Pire-Smerkanich, DRSc; Assistant Professor of Clinical Pharmacy, Department of Regulatory and Quality Sciences; for comments that greatly improved the article. We would also like to show our gratitude to the survey participants for sharing their experiences with us during the course of this research.

Author Disclosure Statement

No conflicting financial interests exist.

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