Supplemental Information for RFA-HG-11-007: Biorepository Industry Standards (UH2/UH3)

National Human Genome Research Institute

National Institutes of Health
U.S. Department of Health and Human Services


Supplemental Information for RFA-HG-11-007: Biorepository Industry Standards (UH2/UH3)

  1. The biorepository should:
    1. Have a unique name
    2. Have a clear mission statement
    3. Specify the types of specimens that can be stored at the facility (eg. Animal, microbial, environmental, plant, or other biological)
       
  2. Policies should be in place on:
    1. How specimens are received
    2. Who can access specimens and how to do it
    3. When to retry or cull a specimen
       
  3. Staffing should include:
    1. A director with experience and training for the type of samples and biorepository activity
    2. Staff sufficient to support the effective operation of the repository
    3. An organizational chart defining relationships of personnel
    4. Written position descriptions
    5. Position descriptions that match the responsibility and experience of the staff
       
  4. Agreements collaborators or subcontractors should match written agreements.
     
  5. Records management should include documented:
    1. Collection, processing, storage and distribution activities of specimens
    2. Activity records that include: training, standard operating procedures (SPO), deviation from SPOs, quality assurance and audits, equipment purchase, equipment repair and preventative maintenance, equipment monitoring, environmental monitoring, specimen location information, safety inspection, safety incidence
    3. Development and implementation of forms for effective recordkeeping
    4. Forms and templates that require a unique name, unique number, version, date originate/last modified
    5. Systems to ensure that the most up-to-date versions of forms are used
    6. Systems for making and tracking corrections to paper and electronic records
    7. Dates recorded in an unambiguous manner eg. dd/mm/yyyy
    8. Policy governing the length of time a record is maintained and archived
    9. Security for electronic records including: back-up system, off-site data storage, pass-word-protected computers, automatic time-out locks on computers, appropriate permission levels for staff or non-staff, accessible records for inspection by authorized personnel, system for access to restricted personal identifiers or other confidential information
       
  6. Facilities ensuring safe and effective environment for samples and data for projected numbers and types of samples. This includes:
    1. Space for present collection and accommodates future growth of the collection
    2. Specific limits for ambient temperature where specimens and sensitive lab equipment are maintained
    3. Sufficient air circulation to prevent excess heat or humidity
    4. Oxygen monitoring devices where there is potential for low oxygen levels
    5. Illumination sufficient for general lighting, task lighting, and emergency lighting
    6. f. Appropriate handling and containment of light-sensitive specimens
    7. Floors that are appropriate to house equipment an refrigerants on a daily basis
    8. Uninterrupted power supplies that serve computer systems and other equipment
    9. Emergency power generator is in place in the event of power loss
    10. Emergency power will run for a minimum of 48 hours
    11. Emergency power generator is tested periodically to ensure load capacity and automatic starting
    12. Limited-access facility for authorized staff and approved visitors
    13. Limited-access specimen storage area that is monitored by intrusion detection system and mechanical locks
    14. Signature log for access to keys, codes, or access cards
    15. Visitor access policy and log in place
    16. Intrusion detection system monitored 24 hrs per day
    17. Alarm-response personnel adequate to respond to any alarm in a timely manner to prevent loss and calls to alternative staff in the event of non-response
    18. Fire prevention system and fire suppression retardants in place
    19. Plan for emergency that are unique to the geographical location (eg. earthquake, brushfire, floods)
    20. Emergency plan that is easily accessible to staff with emergency numbers posted, and annual training on the plan
       
  7. Storage Equipment and Environments for specific types of specimens includes:
    1. Containers for specimens (eg. cryovials) that have been tested in the proposed storage environment
    2. Documented temperature profiles of the storage equipment (e.g. top vs bottom of the freezer) that are tested prior to placing the samples
    3. Adequate liquid nitrogen supplies that are maintained on-site
    4. Daily monitoring of liquid nitrogen levels and rate of use
    5. High and low-level temperature standards established for each sample type
    6. Walk-in storage systems with:
      1. Dual compressors
      2. Internal safety release to allow easy exit
      3. Floor covering that prevents slippage
      4. Interiors oxygen and CO2 monitors
    7. Back-up storage capacity with 1-3% for liquid nitrogen freezers and 10% back-up capacity for mechanical freezers
    8. Written procedure for transferring samples from a failed unit
    9. Monitoring system to detect deviations from normal operating temperatures or other conditions
    10. Monitoring should include on-site and off-site notifications
    11. Off-site alarms with training program and clear lists of first and subsequent responders
    12. Redundant monitoring systems that are activated in the event that the first monitor fails
    13. Alarm system should be tested weekly, monthly and quarterly
    14. Technical staff who visually inspect the temperatures of the equipment each day
    15. Routine evaluation of temperature trends to prevent potential problems
    16. Consistent matches between control displays and monitored values
    17. System in place for equipment calibration
    18. Logs of calibrations that are maintained. These include date, tech name, device used to do the calibration, and the SOP reference number that describes the calibration
    19. Surge protectors in place for equipment as needed
    20. Preventative maintenance plan of equipment that is carried out
    21. Plans for equipment repair by well-trained personnel as needed
    22. Available spare parts for equipment
    23. Plans for timely replacement of equipment is in place
       
  8. Quality Assurance (QA) and Control (QC) and management system (QMS) to track, process, store, and disseminate samples in an accurate and timely manner.
    1. QA program/QC/QMS system describing the commitment to quality
    2. SOP manual for policies and procedures described in detail
    3. Each SOP contains: unique name, unique number, date first introduced, date most recent version, describes the department and staff covered, indicates protective wear required, indicate equipment required, indicate materials required, provide a step-by-step guidance as to how the procedure should be done, indicate the topics covered in the SOP manual, all specimen processing procedures, lab procedures for tests performed in-house, distribution of specimens and associated data, shipping and receiving of specimens, records management practices, QA/QC for instruments, reagents, labels and processed employed in sample collection, processing, retrieval, and dissemination, equipment qualification, maintenance, repair, and calibration, safety program, investigation documentation and reporting of incidences, near-incidences, errors, complaints, adverse outcomes, disposal of medical and other hazardous waste, training programs
    4. Regular review of SOPs (e.g. every two years)
    5. System to ensure that the most current SOP version is followed
    6. System to review the most recent version of the SOP
    7. Regular QA review or audit
       
  9. Safe operation of the repository according to national, regional, and local statutes
    1. Repository representative participates in organization safety committees
    2. Safety officer-led training program, one who monitors, and maintains compliance
    3. Periotic institutional or other safety inspection
    4. Biosafety training for sample collection staff
    5. Policies for personal protective equipment of clothing for staff and visitors
    6. Staff trained in universal precautions
    7. Chemical hygiene plan in place including guidance on:
      1. prevention, containment, and clean-up of spills
      2. safe and lawful disposal of biological materials
      3. plan for ventilation failure with evacuation plan and safety drills
      4. approved areas for eating, drinking, gum-chewing, and make-up or contact lens application
      5. allowable pipetting methods
      6. appropriate use of chemical fixatives
      7. requirements for the use of biological safety cabinets (BSCs)
    8. Electrical cords, plugs and outlets are checked regularly and maintained in good working order
    9. Hand-held fire extinguishers are available
    10. Staff are trained in fire prevention
    11. Physical safety is insured by:
      1. Facility maintenance
      2. Identification and correction of hazards
      3. Gas cylinders are secured
      4. Strong and balanced shelving
      5. Ergonomic procedures
    12. Radioactive safety plan, if applicable
       
  10. Training of staff to perform tasks and promote good quality, operation, and safety compliance
    1. training program is current
    2. training that is task and location-specific
    3. training that is conducted in language in which the employee is conversant
    4. training that is appropriate to the employee's level of comprehension
    5. training files for each worker that includes:
      1. position description with job title, responsibilities, educational experience required to perform the work, an resume or job application form, example of the employee's signature and initials, documentation that the employee has read and understands all SOPs pertinent to their responsibilities, documentation that all required training has been successfully completed, copies of certificates of documented training
    6. Training records record the title of procedures that the employee was trained, the SOP number and version, the trainees signature or initials, the date training was completed, the name of the trainer and the trainer's signature
    7. Staff member is assigned to ensure that training takes place and to maintain SOP training records
    8. Technical staff member is assigned to monitor periodically to ensure compliance and identify additional areas of training that may be required.
    9. Trainers must keep skills current to:
      1. ensure that the trainee understands each procedure and task
      2. provide feed-back on trainees performance
      3. supervises trainee in all tasks until the training phase has been completed
      4. confirm that trainee is comfortable with conduction the task without supervision
      5. make themselves available to the solo trainee as they initially perform the tasks
    10. Staff trained periodically according to their roles and regulations
    11. Cross-training of staff is performed on repository procedures
    12. Training files are archived once the employee is separated from the organization
       
  11. Biological material tracking ensures proper specimen arrival, identification, and shipment including the assurance that:
    1. Unique specimen ID is printed on the label
    2. Labels are typewritten or computer-generated
    3. Labels contain barcodes with the specimen ID, number, or label
    4. Label placement tested under all projected environmental conditions
    5. Biosample information matches specimen shipping voucher or e-voucher
    6. Human-derived samples are devoid of personal identifiers as defined by policy
    7. Computer inventory system tracks the location and status of all samples in the biorepository that:
      1. controls access
      2. configures reports about the specimens held
      3. has the capability to communicate with other databases
      4. validates and makes available data for QA audits
      5. tracks events such as: vial type, volume, collection date, voucher, date of receipt, date of processing, date and location of distribution, thaws, losses, and destruction
      6. provides a full audit trail of changes made with original and changed data, who made the changes, when made, reason for change
    8. All freezers/ refrigerators have unique identifiers with a convention for numbering shelves, racks, boxes, and place within box as needed
    9. If required, human specimen inventory database can track: age at the time of collection, sex, occupation, race, and ethnicity, diagnosis (site histology, stage at diagnosis, date of diagnosis, diagnostic procedure (type and date), type of treatment prior to donation (ie. chemotherapy, radiation), family history, smoking history, height weight, clinical lab values, digital images.
    10. If required, non-human specimen database can track specific information related to each specimen type.
    11. Material transfer agreements (MTAs) are used to define the rights and obligations of the sender and the recipient of samples with allowable use of specimens and data
    12. Shipping logs that tracks:
      1. Invoice numbers
      2. Recipient
      3. Date received
      4. Currier
      5. Number of samples
      6. Study name
      7. Shipping conditions
      8. Key investigator's name
      9. Indication of conformation of receipt
      10. Discrepancies between shipping manifest and actual
         
  12. Packaging and shipping
    1. All appropriate staff receive training in local and international regulations including:
      1. Classification of shipping contents
      2. Selection of packaging based on sample quantity
      3. Type and amount of refrigerant required to maintain temperature for the duration of the shipment
      4. Positioning of the specimens in the refrigerants
      5. Prevention of empty spaces after specimens have been loaded
      6. Prevention of moisture by dessicants
      7. Packing light-sensitive samples
    2. Scheduled sending day takes into account the recipients work week and allows for 2 days delay
    3. Prevention of sending during a recipient holiday
    4. Test reports of packaging to ensure regulation compliance
    5. Test packaging prior to use with specimens
    6. Checklist for sending international packages (country-specific customs, special permits, etc.)
    7. Notification of recipient prior to shipment
    8. Emergency contact for transport of dangerous goods provided
    9. Shipper sends an electronic manifest to the shipper prior to the release of the shipment
    10. Shipper requests state of specimen upon receipt
       
  13. Specimen collection, processing and retrieval
    1. Complete set of SOPs maintained
    2. New protocols, equipment, verified by pilot studies
    3. Timely movement of specimen from receipt to fixation or storage
    4. Timely movement recorded
    5. Aliquot size considerations made with cost and storage requirements in mind
    6. Specimen processing considers both safety and sterility
    7. Sample aliquoting uses sterile pipetting and biological safety cabinet
    8. Specimen stabilizing agents and other procedures are tested for their long term effects on the final assay
    9. Containers used at all stages have been tested for the appropriate conditions employed
    10. Containers pre-labeled to facilitate the process
    11. All appropriate staff have been trained in specimen handling requirements
    12. All collection procedures are approved as ethical
    13. Sample removal has been done by a professional and is confirmed for identity
    14. Retrieval of specimen is verified by the inventory system
    15. Specimen requisition is used to pull sample from storage
    16. All specimens pulled are accounted for by staff
    17. Missing specimens are indicated as "not located" in database
    18. Shipping problems are conveyed to the sender in a timely manner
       
  14. Ethical issues for human specimens
    1. Appropriate consent has been obtained for each specimen according to applicable laws and regulations
    2. Human specimen or data sharing requires informed consent authorization
    3. Operating procedures and policies minimize risk of privacy and confidentiality breeches
    4. All files are available for review by ethics committees and review boards
    5. SOPs and policies respect the community, population and group customs
    6. Benefit sharing with the community of interest has been considered
    7. Policies for sharing of data and specimens are transparent
    8. Disposition of specimens and data upon termination are consistent with informed consent

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Last Reviewed: July 16, 2013