Biospecimen Resource Management and Operations
Daily and long-term responsibilities essential for efficient biospecimen resource management and operations can be diverse and include organizational considerations, space planning and functional design, resource development, evaluation and solidification of infrastructure requirements, constant and consistent review of operational issues, and regular resource evaluation. When executed and practiced in harmony, all of these factors can dramatically improve success in managing and operating a high-quality, highly utilized, and valuable resource.
B.1.1. Organizational Overview of the Biospecimen Resource
An organizational overview can assist in defining the institutional structural components within and around the biospecimen resource. An overview typically begins with description of the organizational mandate; its associated goals, mission, and vision; operational scope; and core areas of research support.
B.1.1.1. Organizational Structure
Organizational structures may vary according to the nature of the biospecimen resource. Thoughtful documentation of the resource’s organizational structure in relation to its parent institution may help to predict needs, promote incorporation of existing resources, and streamline workflow while increasing communication among stakeholders, management, and end users.
- Biospecimen resources should seek to define and document their organizational structure in advance of resource planning and/or development.
B.1.1.2. Organizational Chart
The organizational chart can be a significant tool in supporting existing governance structures through elucidation of roles, responsibilities, chain of command, and requisite reporting relationships.
- Biospecimen resources should develop and publicly display the current organizational chart within the resource.
- Biospecimen resource management should provide a copy of the current organizational chart and discuss with every new staff member as part of the orientation process, reviewing the current management of the institution (Appendix 3).
B.1.2. Biospecimen Resource Personnel
Personnel involved in biospecimen resource management and use, including researchers, technicians, nurses, surgeons, pathologists, anesthesiologists, and assistants should be aware of the purpose and goals of the biospecimen resource (see Section B.1.2.1, Related Personnel Descriptions and Roles). To ensure the collection of high-quality biospecimens for research, personnel should be well qualified and trained to adhere to applicable SOPs. See the BBRB web site [13] and the NCI Biospecimen Research Database [14] for examples of SOPs which can be adapted by biospecimen resources for their own applications [12].
Updated training of personnel should be conducted on a periodic basis, in accordance with applicable regulations and position descriptions [15]. A pathologist or his/her designee — such as a pathology assistant or another individual with applicable training and judgment — should be involved in collecting and processing anatomical pathology biospecimens, including surgical and autopsy tissue and body fluids. It is important that a pathologist determines which biospecimen, or portion thereof, is necessary for complete evaluation and which is excess (remnant tissue) that may be provided to the biospecimen resource for research purposes. The involvement of a pathologist in this process is crucial in order to ensure that patient care is not compromised.
B.1.2.1. Related Personnel Descriptions and Roles
The following general personnel categories may be useful in biospecimen resource planning. Note that these personnel and groupings may not be applicable to smaller biospecimen resources.
- Stakeholders and Governance Team: Stakeholders may include leaders at institutional cancer centers and pathology, surgery, and bioinformatics departments and leaders in clinical research units, translational research, and epidemiology teams. Patient advocates and research participants are also key stakeholders.
- Biospecimen Resource Management Team: Typically consists of a director, associate director, technical director, and director of quality management.
- Adjunct Research Support Teams: May include clinical research coordinators and study nurses, research assistants, laboratory technicians, bioinformatics professionals, clinical residents and fellows, and statisticians.
- Internal Support System: May include space planning, financial administration, comptroller, purchasing, environmental services/maintenance, telecommunications, informatics and marketing.
- External Support/Outsourced Roles: May include vendors, consultants, contractors, architects, and engineers.
B.1.2.2. Oversight Committees
Oversight committees, often composed of experts from outside the biospecimen resource, serve to oversee the resource and support transparent and accountable operations. Care should be taken to define, evaluate, and document any potential conflicts of interests (COIs) for any and all members. The type of oversight committee(s) needed at each biospecimen resource will vary but may include the following:
- Scientific Advisory Committee: Provides strategic guidance, scientific feedback, and advice on resource development to the biospecimen resource management and stakeholders.
- Biospecimen Use (or Access) Committee: Supports access to biospecimens for research through assessment of criteria such as scientific rationale, validity of the scientific project, regulatory adherence, potential conflicts of interest, and fair biospecimen/data allocation practices.
B.1.2.3. Associated Institutional Offices and Adjunct Committees
and Their Roles
Institutional offices and committees play a supporting governance role for biospecimen resources. Such offices can offer tremendous expertise along with essential support for the internal resource and its collaborators.
Examples of associated offices include but may not be limited to the following:
- Office of Regulatory Affairs: Typically established to aid regulatory review and oversight of research protocols.
- Office of Human Subjects Research: Typically performs an auditing function for clinical research trials and related research support centers.
- Office of Research Services: Grant management support and assistance with contract development.
- Technology and Materials Transfer Office: Assists with material transfer agreement (MTA) development and management.
- Legal Affairs: Offers guidance on relevant case law, aids in contractual negotiations and/or disputes.
- Office of Environmental Health and Radiation Safety: Offers advice on biosafety but may also consult concerning resource development and/or expansion.
Additional supporting adjunct committees may include a Clinical Trials Scientific Review and Monitoring Committee, which provides supplemental regulatory, data privacy, and safety review in parallel with the institutional review board (IRB).
B.1.3. Considerations Related to Planning and Development
Consideration of the biospecimen resource mission, operational scope, and objectives is crucial in execution of all stages of the planning process. For startup resources, initial operational planning and developmental considerations should aim to include establishment of a governance structure as well as development of related policy, along with regulatory and procedural standards. Once the foundation is set in place, the next step is to commence biobanking protocol, procedural, and formal business development. For biospecimen resources that function as core facilities and/or service providers, business planning may include financial and cost-recovery modeling. In 2014 BBRB coordinated two such biobanking economics studies through a series of comprehensive surveys, and the development of a web-based planning tool, the Biobank Economic Modeling Tool (BEMT) [16]. The BEMT will aid in better understanding and planning for the true costs of biobanking. Reconsideration of these issues may also be timely for established resources, particularly to address any operational disparities in an effort to support best practices and promote long-term sustainability [17-20].
B.1.3.1 Oversight, Internal Policy, and Procedure Development
Policy development can be crucial to provide a framework to guide operations.
- Biospecimen resources should define, document, and observe policies in alignment with the resource mission, scope, and operational objectives.
- All resource policies should undergo a standardized, documented vetting and approval process.
B.1.3.2. Determination of Procedural and Regulatory Standards
During resource development it can be helpful to review current procedural and regulatory standards and determine which are pertinent to the resource operations.
Biospecimen resource managers should aim to:
- Familiarize themselves with the current best practice documents to determine initial base standards for resource development, operations, management, evaluation, and expansion.
- Orient staff and adjunct teams to current best practice documents and published standards.
- Incorporate best practices and current relevant standards into resource policies, SOPs, and procedures with an emphasis on supporting evidence-based practices ([12, 14], Appendix 5).
B.1.3.3. Business Planning
Business planning can provide justification for financial and institutional commitment and quantification of startup and sustainability costs [17-21].
- Business planning should be integrated into all aspects of operations, biospecimen resource management, and evaluation.
- Resources should aim to establish a documented annual business plan developed with department staff input and aligned with the vision and mission of the resource. Business plan items should be specific, measurable, actionable, relevant, and time bound.
- The resource business plan should also include a formal continuity plan that addresses all possible operational disruptions, including disaster planning.
- If the resource functions as a service center, the business plan should address issues related to service and revenue generation.
B.1.4. Biospecimen Resource Infrastructure and Space Planning
When planning, it is crucial to fully assess startup, operational, and maintenance costs for any and all infrastructure [21, 22]. Some favor a centralized model in an attempt to promote harmonization to achieve standardized, well-annotated, high-quality, robust biospecimen and data repositories. In this regard, it can be helpful for each institution to perform evaluative exercises, for example using the ISBER Self-Assessment Tool [23].
Infrastructure requirements can vary based on the biospecimen resource scope and requirements. Infrastructure requirements include but are not limited to the physical laboratory, office, and adjunct and/or satellite space needs as well as requisite informatics, equipment, storage platforms, telecommunications, and consumables needs.
In general, the baseline requirements should aim to include ample space for the following functions, where appropriate, based on the nature and functions of the resource:
- Collection, receiving, tracking, and shipping as needed.
- Immediate and interim processing (e.g., fine and gross dissection benches).
- Areas to prepare and process blood products.
- Histological preparation.
- Equipment such as safety hoods (laminar flow), centrifuges, freezers.
- Stations for pathology case review.
- Storage for biospecimens, consumables, and related records.
- Office work areas to support data, operational, and end user management.
In addition, some biospecimen resources may include areas dedicated to purification of nucleic acids, tissue and cell culture, single-cell suspension, and other specialized laboratory practices.
B.1.5. Overall Operational Considerations
B.1.5.1. Equipment Selection and Maintenance
Equipment selection complements infrastructure planning and should be considered in parallel with space planning and resource design.
Biospecimen resource management should:
- Consider the following factors when selecting equipment: Current resources and budget, current and future services, need, frequency of use, vendor options, manufacturing lead time, and cost — including maintenance, delivery, warranty, service contracts, lifespan, eco-friendliness, performance, and efficiency cost savings, along with current and future service provision options.
- Aim to factor depreciation for all capital equipment into the cost-recovery plan when appropriate.
- Utilize resource sharing to defray financial investment in equipment.
- Determine if used/sale equipment is appropriate.
- Consider batching service contracts among neighboring resources to save money.
- Review calibration and validation instructions.
- Review preventive maintenance summaries and/or equipment log files after and prior to scheduling all maintenance visits as part of the quality assurance program.
B.1.5.2. Purchasing and Procurement from Vendors
Familiarity with purchasing as well as the overall procurement process can help support best practices; decrease errors in purchasing and product selection; streamline workflow; decrease lags in ordering/purchasing; and increase awareness of institutional documentation requirements, purchasing limitations, and rules. When possible, evaluating multiple vendors for equivalency will reduce the impact to business continuity, for example, if a vendor needs to be replaced or augmented.
B.1.5.3. Project Management
Proactive project management can ensure quality service provision and promote a smooth, efficient operational workflow while avoiding duplication of effort and resources.
When possible, biospecimen resources should:
- Utilize a project management plan that includes, but may not be limited to, a statement of work, deliverables document, and integrated project plan (as needed) for facility-managed projects.
B.1.5.4. Biospecimen Utilization
Biospecimen utilization is the process of biospecimen management in an effort to promote collaboration and timely research.
Biospecimen resources should aim to:
- Assess biospecimen utilization in a timely and efficient manner.
- Document and track utilization in conjunction with the resource inventory management system.
- Share information about their biospecimens to the external community through a biospecimen management information system or other means. One method to publicize basic information about sharable biospecimens is via the NCI Specimen Resource Locator [24] (Section B.6.3, Interoperability). Additional information about specimen resources may be found on the ISBER web site [25].
B.1.6. Biospecimen Resource Evaluation and Assessment
The evaluation process can be a valuable exercise to aid executive decision-making with respect to assessment of future funding needs, overall service quality and effectiveness, customer satisfaction, program results, scientific and financial impact, opportunities for expansion, crucial lessons learned, and program success.
Evaluation should include the following general topic areas:
B.1.6.1. Self-Auditing, Audit Preparedness, and Clinical Research Monitoring
Self-auditing and audit preparedness are cornerstones to support and/or evaluate areas of poor performance as well as success in quality of operations. Audits and surveys may be conducted in relation to monitoring of end-user support for clinical biobanking efforts.
B.1.6.2. Strategic and Long-Range Planning, Setting Benchmarks
Strategic and long-range planning can help to set a resource roadmap, provide opportunities to fine-tune and reset operational focus, offer proof of concept, provide analysis of resource allocation, highlight crucial lessons learned, accelerate decision making and resource growth, and increase communication and understanding of resource benefits.
B.1.6.3. Quantification of Performance, Utilization Review, and Assessment of Continuing Research Needs of the Resource
Formal quantification of performance justifies the benefit, utility, and overall need for the stakeholder’s financial investment in the biospecimen resource. BBRB’s BEMT is designed to support cost recovery and financial planning for biobanks [16].
B.1.6.4. Scientific Impact of the Resource
Formal analysis of scientific impact can provide evidence of the inherent and extrinsic scientific value and contribution of the resource. Proponents of such impact analyses have published guidelines (Biospecimen Resource Impact Factor [26]), but it is not expected that many biospecimen resources will have the financial resources or information they would need to conduct such a self-assessment, except as noted through the ISBER Self-Assessment Tool.