US DEMOGRAPHICS
Question Description
Answer Type
Answer Description
Answer Value
Question Short Name
Question Visibility Rule
Please verify that your biobank operates in the US?
CHECKBOX
☒
My biobank operates in the US or a US Territory
US
Please indicate the state in which your biobank resides:
DROPDOWN
AL
Biobankstate
Show this question when answer "My biobank operates in the US or a US Territory" to the Question: "Please verify that your biobank operates in the US?"
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
WV
WI
WY
Any of the US Territories
US Territories
Does your biobank network collect and distribute specimens from and to all 50 states?
RADIO
Yes
NetworkAll50StatesYN
Show this question when answer “Yes” to the Question: “Is your biobank part of a network of biobanks? (Click 'Need Help' for explanation of a biobanking network)”
No
Please indicate the other states in which biobanks in your network operate:
Same list as above
OtherStatesNetwork
Show this question when answer “No” to the Question: “Does your biobank network collect and distribute specimens from and to all 50 states??
International Demographics
On what continent is your biobank located
North America
Country1
Europe
Asia
India
Africa
Australia
South America
In what North American country is your biobank located?
United States
United Stated
Northamericancountry1
Show this question when answer "North America" to the Question: "On what continent is your biobank located"
Canada
Mexico
Belize
Costa Rica
El Salvador
Guatemala
Honduras
Nicaragua
Panama
In what South American country is your biobank located
Argentina
Southamericancountry
Show this question when answer "South America" to the Question: "On what continent is your biobank located"
Bolivia
Brazil
Chile
Columbia
Ecuador
Falkland Islands
French Guiana
Guyana
Paraguay
Peru
South Georgia and South Sandwich Islands
Suriname
Trinidad
Uruguay
Venezuela
Demographics
GENERAL
How long has your biobank been in operation?
Less than 1 year
DurationOfOperation
1-3 years
1 to 3 years
3-5 years
3 to 5 years
5-10 years
5 to 10 years
Greater than 10 years
Please indicate the phase that your biobank is currently in:
Startup - Staff is putting the bank in operation. No collection or distribution
Startup
Phase
Build up - Bank is operational. Collection started. No distribution yet.
Build up
Expand - Distribution started. Collection expanding. Pursuing new users.
Expand
Operate - Stable collection and distribution.
Operate
Shut-down - (For some banks), collection is stopped. Distribution continues until collections depleted
Shutdown
What the start of your biobank's fiscal year?
January
Fiscalyearstart
February
March
April
May
June
July
August
September
October
November
December
What the end of your biobank's fiscal year?
FiscalYearEnd
ACCREDITATION AND CERTIFICATIONS
Is your biobank:
Accredited
AccreditationStatus
Not accredited
Please specify the organization that provides your accreditation.
TEXT
AccredidationOrg
Show this question when answer "Accredited" to the Question: "Is your biobank:"
Does your biobank plan to participate in the Biorepository Accreditation Program offered by the College of American Pathologists (CAP)?
Y
PursueCAPYN
N
I was not aware that CAP is offering a certification program
Not aware
Is your biobanking currently obtaining or planning to obtain certification?
CertificationYN
Please indicate the type of certification:
ISO 9001 Quality Management System Standard
ISO 9001
CertType
Show this question when answer "Yes" to the Question: "Is your biobanking currently obtaining or planning to obtain certification?"
ISO 27001 Information Security Management Certification
ISO 27001
Other
Please specify:
OtherSpecifyCertType
Show this question when answer “Other” to the Question: “Please indicate the type of certification:”
ORGANIZATIONAL STRUCTURE
Is your biobank part of a:
Healthcare provider
BiobankType
Clinical research organization
Drug or device developer
Commercial biobank
OtherBiobankType
Show this question when answer "Other" to the Question: "Is your biobank part of a:"
Is your biobank part of a network of biobanks? (Click 'learn more' for explanation of a biobanking network)
NetworkYN
Please specify the name of the network:
NetworkName
Show this question when answer “Yes” to the Question: “Is your biobank part of a network of biobanks?” (Click 'learn more' for explanation of a biobanking network)
What functions does your biobank perform within your network?
Collection
RoleinNetwork
Storage
Distribution
Central Management and Administration
DIRECT STAFFING AND OTHER HUMAN RESOURCES
Use this table to describe your biobanks direct staff, management, and associates. Click the 'Need Help' button for more a detailed explanation and set of definitions.
Type of Personnel
Number of Persons
INTEGER
Area of Responsibility
Part-Time Percentage
NUMBER
Budgeted?
Full Time Managers
All
Included in annual budget
Full Time Technical Staff
Associated staff / Off the biobank's budget
Full Time Administrative Staff
Processing
Part Time Managers
Part Time Technical Staff
Retrieval/Distribution
Part Time Administrative Staff
IT Support Staff
Please indicate the changes in staffing levels for any of the types of personnel that will change in the coming year.
Change in Head Count
Number
Reason
Increase
Normal attrition
Decrease
New project work
Reduced funding
Normal expansion in operations
BEST PRACTICES AND QUALITY ASSURANCE
Does your biobank utilize published best practices?
ConformToBestPractices
Please indicate which best practices you follow:
ISBER
BestPracticesList
Show this question when answer "Yes” to the Question: "Does your biobank utilize published best practices?"
OBBR/BBRB
OBBR
BC Biolibrary Framework
Molecular Medicine Ireland (MMI)
MMI
OECD
Please specify other best practices:
OtherSpecifyBestPractice
Show this question when answer "Other" to the Question: "Please indicate which best practices you follow:"
Are you following published best practices for establishing a biobank?
FollowBestPracticeEstablishBiobank
Show this question when answer "Less than 1 year” OR “1-3 years" to the Question: "How long has your biobank been in operation?"
TYPES OF SPECIMENS AND USERS
Please describe the specimen requesters that you currently serve:
Type of Requester
Percent of Requests
Status
Internal
Growing
External independent researcher
Stable
Academic medical center
Declining
Pharma
Commercial biotech
Other biobanks
Please indicate the new types of biospecimen requestors you expect to be able to serve in the next year.
NewRequestorTypes
Please specify
OtherSpecifyRequesterType
Show this question when answer “Other” to the Question: “Please indicate the new types of biospecimen requestors you expect to be able to serve in the next year.”
Please specify the new types of specimens that your biobank will be collecting next year:
Tissue
NewSpecimenTypes
Organ
Blood
Plasma
Serum
DNA
RNA
Urine
Saliva
None
OtherSpecifyBiospecimenTypes
Show this question when answer “Other” to the Question: “Please specify the new types of specimens that your biobank will be collecting next year:”
Operations - Common
Please indicate the number of samples by type in your collection at this time.
Sample Type
Room Temperature
Refrigerated
Frozen
Cryogenic Storage
How many samples by type have you collected in the past 12 months?
How many samples by type were requested in the last 12 months?
Number Requested
How many samples by type were distributed in the past 12 months?
Please describe your specimen collection network:
local collection
We have local collection sites
LocalCollectionSite
How many local collection sites support your bank?
LocalCollectionSiteNum
Show this question when answer "We have local collection sites" to the Question: "local collection"
We have remote collection sites
RemoteCollectionSitesYN
How many remote collection sites support your bank?
RemoteCollectionSiteNum
Show this question when answer "We have remote collection sites" to the Question: "We have remote collection sites"
Please describe your specimen storage network:
central storage facility
We have a single central storage facility
CentralStorageYN
remote storage
We have remote storage facilities
RemoteStorageYN
How many remote storage facilties are part of your biobank?
How many remote storage facilities are part of your biobank?
RemoteStorageFacilityNum
Show this question when answer "We have remote storage facilities" to the Question: "remote storage"
QUALITY MANAGEMENT
How many hours of staff time has been spent to create, review, and approve standard operating procedures? (If this work is not yet completed, please estimate the total time needed to create)
SOPTime
How frequently do you update your Standard Operating Procedures?
Monthly
SOPUpdate
Show this question when answer “Build up - Bank is operational. Collection started. No distribution yet.” OR “Expand - Distribution started. Collection expanding. Pursuing new users.” OR “Operate - Stable collection and distribution.” to the Question: “Please indicate the phase that your biobank is currently in:”
Quarterly
Yearly
Other Specify
OtherSpecifyUpdateSOPs
Show this question when answer “Other” to the Question: “How frequently do you update your Standard Operating Procedures?”
How much time is spent updating your Standard Operating Procedures? (including review and approval time)
SOPUpdateTime
Show this question when answer “Build up - Bank is operational. Collection started. No distribution yet.” OR “Expand - Distribution started. Collection expanding. Pursuing new users.” OR “Operate - Stable collection and distribution.” To the Question: “Please indicate the phase that your biobank is currently in:”
Please estimate the number of hours spent training new employees on your Standard Operating Procedures.
SOPTrainingNewStaffHrs
Please estimate the number of hours spent training existing staff on updated Standard Operating Procedures.
SOPTrainingExistingStaffHrs
How does your biobank document adherence to your SOPS and quality assurance standards?
Our lab management software automatically generates this documentation
System Generated
HowSOPAderence
We manually document this information
Manual
Our lab management software automatically produces a portion of this documentation that we supplement manually
Both System and Manual
Please estimate the number of hours per month spent producing the SOP compliance and quality assurance documentation for your samples.
MthlyHoursSOPCompliance
Show this question when answer “We manually document this information” OR “Our lab management software automatically produces a portion of this documentation that we supplement manually” to the Question: “How does your biobank document adherence to your SOPS and quality assurance standards?”
Does your biobank annotate your biospecimens with scientific data?
AnnotateYN
How are the scientific annotations for your biospecimens generated?
We have fully integrated laboratory management systems that automatically generate the majority of our annotations
Automatic
HowAnnotationsGenerated
Show this question when answer “Yes” to the Question: “Does your biobank annotate your biospecimens with scientific data?”
We manually annotate all of our specimens with scientific data
Manually
Some of our annotations are generated automatically by our lab management system and the rest are annotated manually by staff
Both
Please estimate the number of hours per month spent in recording biospecimen annotations.
MthlyHoursforAnnotations
Show this question when answer “We manually annotate all of our specimens with scientific data” OR “Some of our annotations are generated automatically by our lab management system and the rest are annotated manually by staff” to the Question: “How are the scientific annotations for your biospecimens generated?”
Funding Sources
What is your biobank's total annual budget?
AnnualBudget
How is your biobank planning to sustain funding as budgets are tightening?
Reduce staff
AccountForTightBudget
Reduce scale of operations
Reduce operations
Defer acquisitions of new capital equipment
Defer acquisitions
What plans and/or strategies does your biobank have in place to ensure sustainability?
Stewardship Plan
SustainibilityPlans
Long-term custodianship
What percentage of your annual budget comes from:
Percentage
Type
This source is guaranteed for:
Indicate Name of the Source
Charitable donations
Direct cash
This fiscal year
Support from your host enterprise
Contributions in kind
The next fiscal year
Support from affiliated biobanking network
The next 2 fiscal years
Biobanking grants
The next 3 fiscal years
In-house clinical research grants
Beyond the next 3 fiscal years
Contract specimen collection services
Specimen sales
Other biobanking related contract services
Please estimate the amount of time spent each month developing funding sources:
Hours developing new sources
Hours maintaining existing sources
Staff
Management
Please indicate the importance for your biobank:
1
2
3
Maintaining current funding
Replacing declining funding sources
Establishing new sources of funding
Is your biobank funded as part of publicly provided healthcare services or publicly funded clinical research?
Yes. Our annual budget is fully funded
Budget fully funded
Yes. Our annual budget is partially funded
Budget partially funded
No. Our annual budget is not funded through public healthcare support or publicly funded clinical research
Please categorize the process for appropriating public funds:
We annually request earmarked funds and get approval based on performance and related criteria
Approval based on performance
ProcessforAppropriatingfunds
Show this question when answer “Yes. Our annual budget is fully funded” OR “Yes. Our annual budget is partially funded” to the Question: “Is your biobank funded as part of publicly provided healthcare services or publicly funded clinical research?”
Our funds are not earmarked. We must compete with other usages of public funds in securing our annual budget.
Must compete
Please briefly describe your process:
TEXTAREA
Otherspecifyprocess
Show this question when answer Other Question: Please categorize the process for appropriating public funds:
Please provide any additional detail regarding how you secure public funds to support your biobank.
Otherinfosecurepublicfunds
Show this question when answer “We annually request earmarked funds and get approval based on performance and related criteria” OR “Our funds are not earmarked. We must compete with other usages of public funds in securing our annual budget.” to the Question: “Please categorize the process for appropriating public funds:”
How does your biobank respond to fluctuations in publicly provided funds?
We adjust staffing levels to available funding
FluctuationResponse
Show this question when answer “Yes. Our annual budget is partially funded” to the Question: “Is your biobank funded as part of publicly provided healthcare services?”
We make up the difference with alternative sources of funding
To what degree do you feel that the original sponsors of your biobank bare a long-term responsibility for the stewdardship of your specimen collections?
High - Our original sponsors continue to work to secure long-term funding.
High
Degreeofsponsorstewardship
Medium - Our biobank was founded to be in operation for only a finite period of time, after which specimens will be disposed.
Medium
Low - Our original sponsors expect that the long-term support of our biobank will be assumed by others. (biobank management, other sponsors, etc)
Low
Please provide any additional details related to your answer above that you feel would be helpful.
Additionalinfostewardhip
Who do you think should be responsible for the long-term stewardship of your biospecimens?
WhoResponsibleForStewardship
Cost Information
What were your total costs of operations last year?
OperationCostPreviousYear
What is your total cost of operations this year?
OperationCostCurrentYear
DIRECT COSTS FOR THE CURRENT YEAR
What are your total direct labor costs? (salary and fringe benefits for biobank staff)
DirectLaborTotalCosts
Please indicate the distribution of your costs in percentages for the following parts of the biobank value chain framework. (*Please do not include shipping costs in your ODC's)
Retrieval and Distribution
Budgeted Labor
Associated Labor
Materials
Other Direct Costs (*ODC)
INDIRECT, ADMINISTRATIVE, AND INFRASTRUCTURE COSTS FOR THE CURRENT YEAR
What are your total indirect labor costs? (salary and fringe benefits for management and administrative staff)
IndirectLaborCostTotal
What are your total information technology (IT) costs?
TotalITCosts
What is the estimated total current value of your capital equipment?
CapitalEquipValue
What is your capital budget for new equipment for this year (Please indicate robotic systems, freezers, microscopes, etc).
BudgetNewCapitalEquipCurrentYear
What is your capital budget for replacing old equipment for this year?
CapitalBudgetReplaceEquip
Please estimate your annual shipping costs:
Please provide your yearly costs to ship specimens from collection points to storage by specimen type.
Show this question when answer “We have remote collection sites” to the Question: “We have remote collection sites”
Annual Collection Shipping Cost
Ambient
Dry Ice
LN2
Please provide your yearly costs to distribute specimens among storage locations by specimen type.
Show this question when answer We have remote storage facilities Question: remote storage
Annual Inter-Storage Shipping Cost
Please provide your yearly costs to distribute specimens to requesters by specimen type.
Annual Distribution Shipping Cost
What do you project your cost of operations to be next year?
OperationCostsNextYear
Does your biobank pay for use of infrastructure (physical space, energy, phone, other utilities, etc) as part of your budget?
InfrastructurePayStatusYN
No, our infrastructure is provided by our host enterprise
Please indicate your biobank's annual infrastructure costs (in dollars):
InfrastructureCosts
Show this question when answer “Yes” to the Question: “Does your biobank pay for use of infrastructure (physical space, energy, phone, other utilities, etc) as part of your budget?”
Challenges - Common
Please indicate the criticality for the challenges that your biobank is currently facing or anticipates facing in the next 12 months.
Rating
Describe your MAJOR issue/challenge
Describe your solution, if applicable
Solution considered as best practice?
CHECKMARK
Sustaining current growth
High (This is a critical issue)
Acquiring new specimens
Medium (This is a challenge but of moderate difficulty)
Low (This is a challenge but we have a means of dealing with it)
Keeping pace with quality standards
N/A (not concerned)
Managing regulatory demands
Labor attrition
Managing changing consent
Data security
Integrating our information systems
Keeping up with emerging technologies
Centralizing biobank operations in my enterprise
Establishing a competitive charge structure for specimens
Establishing a competitive charge structure for specimen related services
Securing sustainable funding
Summary - Common
Please tell us how useful the following information and tools would be to your biobank.
Timeframe
Preferred Format
Comments/Desirable Features
Annual Strategic Planning Guide
My biobank really needs this
Needed now
Financial Benchmark
My biobank would find this somewhat useful
Needed in the next 6 months
Operational Benchmark
My biobank does not need this
Needed in the next year
Biobanking Business Case Development Guide
My biobank already has this
Inventory Management Tool
Cost and Revenue Tracking
Biobanking Technology Comparison Guide
Please use this table to suggest new tools and information that you would find useful.
Description
Format
Web Application
Document
Excel Sheet
January 31, 2013 12
