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Dartmouth Biospecimen Storage Facility Service (DBSF)

Summary:

The DBSF is for long term storage, generally for archival and back up specimens (e.g. -140⁰C, -80⁰C, -20⁰C and 4⁰C)

The facility is also equipped with 24/7 real-time and surveillance cameras

The facility has redundant 24/7 temperature monitoring with alarms for each freezer and emergency response upon alarm by DBSF staff:

The Facility is OHSA compliant and meets Dartmouth EHS policies and standards.

Please see protocols for documents on:
Applicants Summary Fact Sheet
Operating Policy
Permitted User Certification
Storage Facility Application
Official Comprehensive SOP'S
PI Certification, Permitted Users and Certification

Affiliations:

People:

    Resources:

    Protocols

    • Dartmouth Biospecimen Storage Facility ("DBSF") Official PI Certification ( Protocol )

      Certification
      The undersigned certifies to Trustees of Dartmouth College that (i) he/she is the Principal Investigator for the research project known as ______________________________________________________ (the "Research Project"), (ii) each of the persons listed below are "Permitted Users" (as defined in the Operating Policy for the Dartmouth Biospecimen Storage Facility ("DBSF")) of the DBSF in connection with the Research Project, and (iii) each of the persons listed below has completed all training required pursuant to Section 8.1 of the DBSF Comprehensive Standard Operating Procedures (Doc. No. DBSF_SOP 001, Version 10.09.14) and all other training relating to laboratory safety or the conduct of research required by other Dartmouth College policies, including policies of the Dartmouth College Office of Environmental Health and Safety.

      Date: ____________________ _____________________________________
      _____________________________________
      [Print Name]

      Permitted Users:

      ___________________________

      ___________________________

      ___________________________

      ___________________________

      ___________________________

      ___________________________

      ___________________________

      ___________________________

    • Dartmouth Biospecimen Storage Facility (DBSF) Application ( Protocol )

      Dartmouth Biospecimen Storage Facility (DBSF)
      Application

      Contact Information

      Investigator Name:
      Location:
      Phone:
      Email:


      DBSF Eligibility criteria:

      1. Use of DBSF is limited to the following:

      a. An organization within Dartmouth College, including schools (and departments thereof) and research centers,

      b. An individual employed or engaged as independent contractor by Dartmouth College or holding a faculty or other appointment from Dartmouth College, in each case in connection with research conducted by them or their supervisors within the scope of their employment, engagement or appointment at Dartmouth College, and

      c. Another organization or and individual approved by the Provost or his or her designee upon such terms and conditions approved by him or her.

      Applicant meets one or more of the eligibility requirements described above:

      Please respond yes or no: and indicate applicable criteria (if c, please attach a copy of the relevant approval): ______________________________________.

      2. DBSF prohibits storage of materials in the following categories:

      a. Radioactive or radio-labeled materials (radioactive means any material with activity above background radiation levels)

      b. Hazardous chemicals including flammable, corrosive, reactive or toxic materials (de-minimus volumes of specimen preservative are permitted)

      c. Select Agents as defined by the United States Department of Agriculture Animal and Plant Inspection Service

      d. Biological materials classified as CDC containment Biosafety Level 3 or higher.

      Materials intended for storage do not include any of the prohibited described above:

      Please respond yes or no: . If yes, please describe applicable materials: ____________________________________________________________________________.

      Description of Freezer/Refrigerator Purpose:
      Types of samples stored:



      If this freezer supports a core facility, please provide the name of the core, the faculty director and facility manager and a detailed description of the core:



      If this freezer supports your peer-reviewed research, please provide the title of the grant, the grant number, years of awarded funding, and details regarding your research:



      If this freezer supports your individual research, please provide details regarding your NIH funding or extramural funding, and details regarding your research:



      If this freezer supports research, but does not fit into the categories listed above please provide the details regarding your research and the justifications for occupancy:



      Service charge for DBSF use is $50.00 per month per freezer/refrigerator for each piece of equipment listed in this application. Applicants are responsible for all costs associated with moving and installation of equipment (e.g. connection to thermal alarms) at the DBSF. Please provide contact for Department or grant administrator and account string for billing of DBSF services:



      Please list the model name and description of freezer (e.g. size, electrical outlet requirement) you plan to move to the DBSF.



      Provide names and both duty and off-hour contact information for Investigator’s primary, secondary and tertiary points of contact for freezer/specimen issues and names and names and contact information for all other requested permitted users who will be allow access to the DBSF and the applicant’s freezers and samples:



      Anticipated Occupancy Date:

      I have read and understand the DBSF Operating Policy, EHS policies and procedures, DBSF SOP and DBSF applicant factsheet.
      I understand service charge for DBSF use is $50.00 per month per freezer/refrigerator for each item of equipment listed and associated associated costs listed in this application and in the DBSF Operating Policy and SOPS .
      I understand that non-compliance with DBSF Operating Policy, EHS policies and procedures, DBSF SOPs and failure to pay service charges may result in sanctions against users by Provost in accordance with DBSF Operating Policy.

      Signature of Investigator:

      Date:

    • Dartmouth Biospecimen Storage Facility (DBSF) Certification ( Protocol )

      Certification
      The undersigned certifies to Trustees of Dartmouth College that (i) he/she has read the Operating Policy for the Dartmouth Biospecimen Storage Facility (DBSF), Version dated April, 2014 (the "Operating Policy") and the DBSF Comprehensive Operating Procedures (Doc. No. DBSF_SOP 001, Version 10.09.14) (the "SOPs"), (ii) he/she understands the provisions of the Operating Policy and the SOPs, including the fact that his/her failure, or the failure of Permitted Users (as defined in the SOPs) under his/her supervision, to comply with the Operating Policy or the SOPs, may result in the revocation of his/her authorization to utilize the DBSF or the imposition of other sanctions as provided in Section 7 of the Operating Policy, and (iii) he/she agrees to comply with the Operating Policy.

      Date: ____________________ _____________________________________
      _____________________________________
      [Print Name]

    • Dartmouth Biospecimen Storage Facility (DBSF) Comprehensive Standard Operating Procedures (SOPs) ( Protocol )

      1. Distribution – These Comprehensive Standard Operating Procedures (SOPs) must be read by all staff of the Dartmouth Biospecimen Storage Facility (DBSF), each Permitted User (defined in the Operating Policy for the DBSF), the On-Call List Members (defined in Section 2.3.1) and all other Dartmouth College personnel who require regular access to the DBSF in connection with the performance of their assigned duties.

      2. Facility Description

      2.1. Location and Purpose of the DBSF; Management of the DBSF

      2.1.1. The DBSF is operated by the Geisel School of Medicine at Dartmouth as a Shared Resource. The DBSF is a component of The COBRE Center of Molecular Epidemiology Biorepository Core (Biorepository Core) consisting of a collection of freezers located in a specially designated room at 56 Etna Road, Lebanon, NH. The freezers are used to store biological materials critical to the research conducted by Dartmouth researchers.

      2.1.2. Responsibility for the general administration of the DBSF is vested in the DBSF Operations Committee, a body consisting of Dartmouth College faculty and staff approved by, and reporting to, the Provost of Dartmouth College or his or her designee. Day-to-day oversight responsibility for DBSF operations is vested in the Biorepository Core Laboratory Manager and staff (DBSF Staff), of which one person has been designated to act as the DBSF Coordinator. The DBSF Staff will maintain an organization chart identifying key personnel with responsibilities for the DBSF and including their relevant contact information.

      2.1.3. Rules and regulations governing the operation of the DBSF are set forth in the Operating Policy for the DBSF (Operating Policy) and Standard Operating Procedures issued pursuant to the Operating Policy (SOPs).

      2.2. General Building and Facility Access; Building Security

      2.2.1. Access to the DBSF (but not the DBSF freezers, access to which is governed by Section 3.1) is restricted to the DBSF Staff, the members of the Operations Committee, the On-Call List Members (defined in Section 2.3.1.), staff of the Dartmouth College Office of Environmental Health and Safety (EHS) and the Dartmouth College Office of Facilities Operation and Management (FOM) who have been identified by EHS and FOM to the DBSF Coordinator as being authorized to have such access, staff of the Dartmouth College Office of Safety and Security (Safety and Security) and the Dartmouth College Office of Risk Management (Risk Management) and Permitted Users. The building itself is not locked since there are multiple tenants in the building. Access to the DBSF from within the building is controlled by a card reader that allows access by authorized individuals.

      2.2.2. The building at 56 Etna Road is patrolled by Safety and Security at least twice per day. DBSF Staff should contact (i) Safety and Security if there is a problem with security during regular hours and (ii) Safety and Security and the Lebanon Police Department if there is a problem with security outside regular hours.

      2.3. System Monitors; Back-Up Generator, Freezers and Other Equipment; Sprinkler System

      2.3.1. The freezers are monitored continuously for temperature or power failures by FOM through the campus wide Honeywell monitoring system based on the Hanover Campus. The Honeywell system monitors the freezers for power and temperature failures by current returning in the low voltage electrical wires connecting the freezer alarm contacts to a panel located in the DBSF. If an alarm condition occurs on any of the inputs, FOM Trouble Shooters on the Hanover Campus will receive a message on their monitors and will notify by phone at least one of the individuals designated by the Administrative Coordinator for Shared Resources to serve as members of the "On-Call List" (the On-Call List Members), indicating the DBSF freezer identification number of the freezer that caused the alarm. In addition, the Honeywell system will send an alarm to an interconnected Tasco Security, Inc. (Tasco) system that will alert the Tasco Office in Lebanon, NH. Tasco will call the On-Call List Members to inform them of the alarm condition, also indicating the DBSF freezer identification number of the freezer that caused the alarm. The DBSF also has a wireless monitoring system manufactured by Rees Scientific (Rees). This system enables the DBSF Staff, through the web, to monitor and record functional and operational parameters of the freezers and includes functionality for the immediate notification of DBSF staff and the On-Call List Members of any problems or issues with a freezer via phone, email or text messaging services. Freezer room ambient air temperature is measured by Thermisters and monitored by the Honeywell System.

      2.3.2. The DBSF shares a 1500 KW emergency generator with the Dartmouth College Data Center located in the same building. It has been determined that the generator will use 30% of its capacity to provide power to both facilities in the event of a commercial power failure. FOM is responsible for engaging a company to supply fuel for the generator.

      2.3.3. In the event of a generator failure another company engaged by FOM will provide a back-up unit through Dartmouth College. In the event that any DBSF Staff Member or On-Call List Member becomes aware of a generator failure, that person should immediately call the FOM Trouble Shooters at 603-646-2344. The FOM Trouble Shooters will implement procedures for a back-up generator.

      2.3.4. The DBSF is protected by an automated sprinkler system which when activated triggers an alarm to a monitoring service and the Lebanon Fire Department.

      2.3.5. The Lebanon Fire Department has a call list of emergency numbers to call in the event of a fire alarm at the DBSF. Emergency numbers are also posted on the outside door at 56 Etna Road and on the outside of the entry door to the DBSF. The Lebanon Fire Department also has key cards allowing it entry to the DBSF.

      2.3.6. Empty operational freezers (Back-Up Freezers) at -80°C temperature are maintained at the DBSF for use in the event of mechanical failure of an active freezer unit. Back-Up Freezers for -140°C freezers, -20°C freezers and 4°C refrigerators will be added to the DBSF if and when an application by a Responsible PI (defined in Section 3.1.1) to install these types of equipment at the DBSF is granted. Signs are posted on the Back-Up Freezers designating them as such. The capacity of the Back-Up Freezers represents only approximately 5% of the total capacity of the all freezers located at the DBSF.

      3. Facility Operations

      3.1. Access to Freezer Interiors

      3.1.1. Access to the interiors of the DBSF freezers is limited to Permitted Users, the DBSF Staff, the On-Call List Members and freezer maintenance and repair vendors (Service Vendors) authorized by the relevant Principal Investigator leading the research study (Responsible PI) or the relevant laboratory manager for the research study (Laboratory Manager). Access to the DBSF freezers by Permitted Users and Service Vendors will be available BY APPOINTMENT ONLY on normal work days between 8:00 AM and 4:00 PM. Access will not be available at other times during weekdays or on weekends or holidays, including Dartmouth College's December holiday break, except in the case of an emergency. The DBSF Coordinator shall determine, in his or her discretion, whether an emergency that warrants such access exists.
      3.1.2. A Permitted User may not access the DBSF freezers unless prior thereto (i) the Responsible PI has informed the DBSF Coordinator in writing that such individual is a Permitted User and (ii) such individual has completed the training described in Section 8.1 and has provided the DBSF Coordinator a written certification that (x) s/he has read the Operating Policy and all outstanding SOPs, (y) s/he understands the Operating Policy and such SOPs, including the potential sanctions which may be imposed upon her or him for non-compliance therewith, and (z) s/he agrees to comply with the Operating Policy and such SOPs.
      3.1.3. Permitted Users, or in the case of Service Vendors, the Responsible PI or the Laboratory Manager, must request an appointment for access to the DBSF freezers by calling the DBSF Coordinator at 603.513.8188 to schedule an appointment or by making an appointment through the Norris Cotton Cancer Center Core Operations website at https://freedom7.dartmouth.edu/login. Any request for non-emergency access must be made at least twenty-four (24) hours in advance.
      3.1.4. Permitted Users and Service Vendors must be accompanied by DBSF Staff, or in the case of an emergency service call or a freezer alarm incident occurring during non-regular hours, by an On-Call List Member, when in the building. An authorized DBSF Staff member, or in the case of an emergency service call or a freezer alarm incident occurring during non-regular hours, an On-Call List Member, will meet Permitted Users and Service Vendors at the door of the DBSF at the appointed time to allow entry. PERMITTED USERS MUST SHOW THE DBSF STAFF MEMBER OR THE ON-CALL LIST MEMBER, AS APPLICABLE, THEIR DARTMOUTH COLLEGE OR DARTMOUTH-HITCHCOCK IDENTIFICATION CARDS IN ORDER TO GAIN ACCESS TO THE DBSF.
      3.2. General Procedures regarding Use of DBSF Freezers
      3.2.1. Permitted Users are expected to handle their own specimens and to follow established protocols for the safe and proper handling of biological specimens. DBSF STAFF WILL NOT DEPOSIT OR RETRIEVE SPECIMENS FOR PERMITTED USERS. SERVICE VENDORS ARE NOT ALLOWED TO HANDLE ANY SPECIMENS. THE RESPONSIBLE PI, THE LABORATORY MANAGER OR ANOTHER PERMITTED USER DESIGNATED BY THE RESPONSIBLE PI OR THE LABORATORY MANAGER MUST BE PRESENT AT THE DBSF WHEN HIS OR HER SERVICE VENDOR IS ON SITE IN ORDER TO MOVE SPECIMENS IF NECESSARY OR MUST HAVE MOVED SPECIMENS PRIOR TO THE SERVICE VENDOR'S VISIT.
      3.2.2. The DBSF is NOT a research laboratory. Therefore, no working benches or Biological Safety Cabinets are provided for pipetting or other lab procedures. Movable carts will be available for use during specimen transfers.
      3.2.3. Permitted Users must provide their own supplies, and ensure that Service Vendors have appropriate supplies, such as Personal Protective Equipment (see Section 9.2), transport containers, ice, dry ice, and other supplies as needed.
      3.2.4. The Responsible PI will have one or more keys to each freezer in which specimens for his/her studies are stored. PERMITTED USERS SHOULD OBTAIN A KEY TO THE APPLICABLE FREEZER FROM THE RESPONSIBLE PI PRIOR TO ARRIVING AT THE DBSF OR THE DBSF SHALL PROVIDE A KEY TO THE PERMITTED USER FROM THE DBSF KEY BOX.
      3.2.5. PERMITTED USERS AND SERVICE VENDORS MUST BE ACCOMPANIED BY A MEMBER OF THE DBSF STAFF WHEN ACCESSING A FREEZER.
      3.2.6. The cabinet temperature of the freezers is extremely cold, ranging between -126°C and -154°C for -140°C freezers, between -72°C to -88°C for -80°C freezers, between -15°C to -25°C for -20°C freezers and between 2°C and 8°C for 4°C refrigerators. Do not allow exposed skin to come in direct contact with contents stored in an operating freezer as severe frost bite may result. Permitted Users, DBSF Staff, On-Call List Members and Service Vendors must wear adequate Personal Protective Equipment (see Section 9.2) when handling contents stored in the freezers or any time there is reasonable probability of coming into contact with the extremely cold surfaces of the freezer’s interior.
      3.2.7. Glove liners may be worn under Latex or Nitrile gloves when manipulating specimens to provide marginally more protection from the cold temperature than Latex or Nitrile gloves alone. However, the liners will NOT provide adequate protection from prolonged exposure to these extremely cold surfaces. Insulated cryo gloves (blue gloves) are strongly recommended when accessing items stored in -140°C freezers or any time prolonged handling of towers or boxes in any of the freezers is anticipated.

      3.2.8. PERMITTED USERS, DBSF STAFF, ON-CALL LIST MEMBERS AND SERVICE VENDORS SHOULD ADDRESS QUESTIONS ABOUT APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT TO THE DBSF COORDINATOR OR THE APPLICABLE LABORATORY MANAGER.

      3.2.9. Permitted Users must adhere to the following general procedures:
      3.2.9.1. On upright freezer models, keep the pressure equalization port clear of frost build up and stored contents. This port aids in relieving the sudden air pressure change resulting when warm room temperature air is trapped in the cabinet due to door opening and closing. Permitted Users must inform DBSF Staff immediately if they notice any frost build up or other blockage of the equalization port. DBSF Staff will note such condition, BUT IT IS THE RESPONSBILITY OF THE PERMITTED USER, THE RESPONSIBLE PI OR THE LABORATORY MANAGER TO FIX THE PROBLEM OR ARRANGE FOR A SERVICE VENDOR TO DO SO.
      3.2.9.2. Do not touch the lower left side of the cabinet exterior near the “hot surface” warning label (upright freezer models only). The pressure equalization port can get hot immediately after it is activated.
      3.2.9.3. Do not overload the freezer with warm specimens. The freezers are not “rapid-freeze” devices. Freezing large quantities of liquid, or high-water content items, will temporarily increase the cabinet temperature and cause the compressors to operate for a prolonged time period. Do not continue to add specimens if the temperature of the freezer has reached: -126°C or warmer for a -140°C freezer, -72°C or warmer for a -80°C freezer, -15°C or warmer for a -20°C freezer or 8°C or warmer for a 4°C refrigerator.
      3.2.9.4. Add room temperature specimens to the freezers in small batches, allowing ample time between batches for the freezer cabinet temperature to recover to operating temperature.
      3.2.8.1. Do not open the freezer door for prolonged periods. Cabinet temperature air escapes rapidly and is replaced with higher humidity room temperature air, which results in greater frost build-up.
      3.2.8.2. On chest style freezers, double check that the sub-lids are properly positioned before closing the freezer lid. These sub-lids are necessary to maintain correct temperature, moisture control, and economy of operation.
      3.2.8.3. On upright freezer models, when closing the door make sure the latch engages fully with the strike.
      3.2.8.4. Freezer doors and tops must be kept clear of items that will interfere with access to the freezer contents.
      3.2.8.5. For long term storage, use the correct tower design for the style of freezer. The towers are designed to maximize storage capability for the specific style freezer and maintain specimens in an upright position.
      3.2.8.6. DO NOT PLACE OPEN TEST TUBES OR CRYOVIAL RACKS WITH SPECIMENS IN THE FREEZERS.
      3.2.8.7. Specimen boxes stored in freezers must be securely closed and, whenever possible, stored in an appropriate tower. Although not ideal, plastic tubs may be used for temporary storage of boxes. PLASTIC TUBS MUST BE UNIQUELY IDENTIFIED, I.E., LABELED WITH THE APPLICABLE TECHNICIAN'S INITIALS AND A NUMBER.
      3.3. Specific Procedures for Adding and Retrieving Specimens
      When adding or retrieving specimens, Permitted Users must comply with the procedures set forth in this Section 3.3 and must follow the Occupational Safety and Health Administration Bloodborne Pathogen Standard (°9 CFR 1910.1030) for handling potentially biohazardous specimens. DBSF Staff accompanying Permitted Users to the freezers should monitor the actions of Permitted Users to ensure their compliance.
      3.3.1. Check the temperature before opening the freezer. Confirm that the cabinet temperature is within normal operating range, i.e., as indicated on the external digital reader, is within the range set forth in Section 3.3.2. If the cabinet temperature is not being displayed, press the Cabinet Temperature control on the freezer control panel to view the current temperature.
      3.3.2. If the freezer temperature is exceeding the alarm set points, i.e., the temperature failure light on the freezer display is flashing, DO NOT OPEN THE FREEZER. Wait until the temperature returns to normal operating range (see Section 3.3.2.1). If the temperature does not return to normal operating range within two (2) hours, follow the procedures set forth in Sections 3.3.10 through 3.3.12.
      3.3.2.1 Normal operating ranges are as follows:
      (w) for -140°C freezers, -126°C to -154°C;
      (x) for -80°C freezers, -72°C to -88°C;
      (y) for -20°C freezers, -15°C to -25°C; and
      (z) for 4°C refrigerators, 2°C to 8°C.
      3.3.3. If the freezer cabinet is within normal operating temperature limits, open the freezer door or lid carefully and in a controlled manner. Do not allow the freezer door or lid to swing open rapidly so that the hinge mechanism is stressed in halting the momentum of the door or lid. Chest freezer lids have a spring loaded hinge mechanism which is easily damaged by abusive handling.
      3.3.4. Upright freezer models - Open the appropriate shelf/inner door. Chest models – lift the appropriate sub-lid.
      3.3.5. When adding an inventory rack or tower to a freezer:
      3.3.5.1. Ensure the rack or tower is clearly and correctly labeled.
      3.3.5.2. Carefully and quickly place the rack or tower in the freezer cabinet. DO NOT BOUNCE THE RACK OR TOWER AGAINST THE FREEZER TEMPERATURE SENSOR BRACKET OR THE WALLS OF THE FREEZER.
      3.3.6. When adding specimen boxes to a rack or tower already stored in the freezer:
      3.3.6.1. Ensure that the specimen boxes to be added are clearly and correctly labeled and securely closed.
      3.3.6.2. Select the appropriate rack or tower and carefully remove it from the freezer sufficiently to access the box slots needed. If adding several specimen boxes, or if there is any difficulty or delay in placing boxes in the selected tower, carefully remove the entire rack or tower from the freezer, close the freezer, and then quickly add the boxes to the tower. Replace the rack or tower in the freezer when done.
      3.3.7. When retrieving a rack, tower or box from a freezer:
      3.3.7.1. Select the appropriate rack, tower or box.
      3.3.7.2. Carefully remove the entire rack, tower or box from the freezer. DO NOT PULL THE RACK, TOWER OR BOX IF IT APPEARS TO BE CAUGHT ON SOMETHING OR FROZEN IN PLACE. It probably is, and using added force to move the item will most likely cause unnecessary and possibly costly damage. Determine what is causing the interference and address the issue accordingly.
      3.3.8. After adding or removing items, immediately replace and correctly position the sub-lids (chest models) or close the inner shelf doors (upright models), and close the freezer door or lid in a controlled manner. DO NOT SLAM THE LID CLOSED. This can damage the hinges. Double check the door or lid is closed properly and the door latch is securely fastened (upright models).
      3.3.9. If at any time during this process the freezer cabinet temperature exceeds the temperature alarm set points, IMMEDIATELY CLOSE THE FREEZER. Wait until the temperature returns to normal operating range (see Section 3.3.2.1). If the temperature does not return to normal operating range within two (2) hours, follow the procedures set forth in Sections 3.3.10 through 3.3.12.
      3.3.10 The following steps should be taken by Permitted Users or On-Call List Members, as applicable, with respect to any freezer as which the events described in Section 3.3.2, 3.3.9 or 12.1.6 have occurred (such freezer is hereafter referred to as a failed freezer):
      3.3.10.1 Check the Freezer Specimen Inventory Forms on the Back-Up Freezers, as well as open the Back-Up Freezers, to determine if there is sufficient capacity in one or more of them to hold the specimens contained in the failed freezer. If such capacity is available, such specimens must be moved into one or more of such Back-Up Freezers in accordance with the specimen handling guides set forth in Sections 3.2 and 3.3. If such capacity is not available or is available for only a portion of the specimens contained in the failed freezer, the excess specimens may be stored at the DBSF on ample dry ice for no more than seventy-two (72) hours. Dry ice sublimates at a rate of five (5) to ten (10) pounds per hour. NOTE THAT THERE IS NO DRY ICE AT THE DBSF AND ANY PERSON CHOOSING TO STORE THE SPECIMENS ON DRY ICE MUST SUPPLY ADEQUATE AMOUNTS OF DRY ICE. IF LARGE VOLUMES OF DRY ICE ARE REQUIRED, CONTACT EHS FOR A CONSULTATION.
      3.3.10.2 If the freezer failure occurs while a Permitted User is attempting to add or removed specimens and the failed freezer is shared with other laboratories, the Permitted User must contact the relevant Responsible PI(s) or Laboratory Managers and instruct them to come to the DBSF promptly to remove their specimens. If such persons do not arrive at the DBSF within two (2) hours after such contact has been made (including where an oral or written message has been left), the Permitted User must move all the specimens contained in the failed freezer to one or more Back-Up Freezers or store them on ample dry ice (see Section 3.3.10.1) and in connection therewith follow the procedures for handling specimens set forth in Sections 3.2 and 3.3. SPECIMENS MAY BE MOVED TO A NON-BACK-UP FREEZERS IF AND ONLY IF THE APPLICABLE RESPONSIBLE PI OR LABORATORY MANAGER HAS GIVEN WRITTEN PERMISSION (INCLUDING BY EMAIL) TO DO SO.
      3.3.10.3 If the freezer failure occurs other than while a Permitted User is attempting to add or remove specimens from the failed freezer and occurs during business hours (9:00 a.m. to 5:00 p.m.), the On-Call List Member should immediately call the Responsible PI(s), the Laboratory Manager(s) or any other person(s) designated by the Responsible PI(s) to respond to emergency calls (each, a Responder) and instruct such Responder(s) to come to the DBSF immediately (even if it means that such person must arrive at the DBSF after business hours) to move the specimens contained in the failed freezer to one or more Back-Up Freezers or, if applicable, to place the specimens on dry ice. In conducting such activities Responders shall follow the procedures for handling specimens set forth in Sections 3.2 and 3.3.
      3.3.10.4 If no Responder arrives at the DBSF within two (2) hours of receipt of a call from the On-Call List Member, the On-Call List Member must move the specimens contained in the failed freezer to one or more Back-Up Freezers and in connection therewith follow the procedures for handling specimens set forth in Section 3.2 and 3.3. If the freezer failure occurs other than while a Permitted User is adding or removing specimens from the failed freezer and occurs outside business hours, the On-Call List Member must move the specimens contained in the failed freezer to one or more Back-Up Freezers and in connection therewith follow the procedures for handling specimens set forth in Sections 3.2 and 3.3.
      3.3.10.5 If there is no available Back-Up Freezer space at the DBSF and arrangements cannot be made to store the specimens contained in the failed freezer on dry ice or in another freezer at the DBSF, leave the freezer shut until arrangements can be made to transport the specimens contained therein to another location.
      3.3.10.6 When the failed freezer has been emptied, turn the failed freezer off and unplug it and disconnect the freezer alarm plug.
      3.3.10.7 Contact the Responsible PI or Laboratory Manager so such person can make arrangements for a service call.
      3.3.11 Record the specimens added or removed from the freezer, including any failed freezer, on the current Freezer Specimen Inventory Form clipped to the freezer. In the case of a freezer that is not a failed freezer, provide the DBSF with an updated freezer inventory, or in the case of a shared freezer, an updated inventory of the specimens stored in the freezer by the applicable laboratory. The updated inventory must be emailed to the DBSF Coordinator within forty-eight (48) hours of the addition or removal of any specimens, or, at such time as a computer becomes available at the DBSF, update the inventory prior to departing the DBSF. In the case of a failed freezer that has been emptied, record the removed specimens on the Freezer Specimen Inventory Form on the front of the Back-Up Freezers in which they are placed or, if the specimens are temporarily stored at the DBSF on dry ice, on a Freezer Specimen Inventory Form attached to the storage box.
      3.3.12 Used ice, dry ice, containers or other items utilized to store or retrieve specimens may not be disposed on the DBSF premises.
      3.3.13 Specimens from failed freezers may be maintained in Back-Up Freezers (i) for no more than two (2) weeks, in the case of failed freezers that need not be replaced and (ii) for no more than eight (8) weeks in the case of failed freezers that must be replaced. The DBSF Coordinator may grant extensions of the foregoing times in his or her sole discretion. Repair of failed freezers, removal of failed freezers and delivery of new freezers shall be conducted in accordance with Section 3.1. Where a failed freezer to be replaced is not removed in a timely fashion, the DBSF Staff shall arrange for the removal and disposal of such freezer and the Responsible PI will be charged for the cost thereof.
      3.4. Freezer Maintenance
      3.4.1. Individual equipment manuals from the manufacturer of each freezer are located on-site at the DBSF.
      3.4.2. Except as provided in Section 3.4.5, the Responsible PI or the applicable Laboratory Manager will be responsible for the maintenance and repair of his or her own equipment, including the freezers assigned to him or her. Where a freezer is shared by two or more Responsible PIs, they shall allocate responsibility for maintenance and repair tasks among themselves.
      3.4.3. FOM recommends the following vendors for freezer repairs:
      MJ Hayward Mechanical/Electrical
      12 Commerce Avenue
      West Lebanon, NH 03784-1669
      (603) 298-6981 (emergency service and regular maintenance)
      ARC Mechanical Contractors
      229 Depot Street
      Bradford, VT 05033
      or
      1 Mechanic Street
      Lebanon, NH 03766

      802-222-9255 or 603-443-6111 (regular maintenance)
      802-222-9255 (emergency service)
      3.4.4. Regular maintenance or repair service must be scheduled in accordance with the procedures set forth in Section 3.1.3. Emergency service must be scheduled by contacting the DBSF Coordinator via the mechanisms set forth in Section 3.1.3.
      3.4.5. The DBSF Staff will be responsible for:
      3.4.5.1. Maintaining adequate clearance space (a minimum of six (6) inches) on the sides and rear of each freezer to ensure proper airflow. When moving a freezer, always grasp cabinet surfaces; never pull the freezer by the latch handle.
      3.4.5.2. Cleaning freezer vent filters.
      3.4.5.3. Tracking and recording maintenance service calls and contact the relevant Responsible PIs or Laboratory Managers when equipment is due for service.
      3.4.5.4. Maintaining DBSF equipment provided by the DBSF Staff.
      3.4.5.5 Notifying the Responsible PI, the Laboratory Manager, or any Permitted User who is then on-site of any non-alarm problem observed so that the Responsible PI, Laboratory Manager, or any such Permitted User may fix the problem or arrange for a Service Vendor to do so.
      4. Disposal of Specimens

      4.1. NO SPECIMENS MAY BE DISPOSED WITHIN THE DBSF. All specimens stored at the DBSF MUST be transported back to the research laboratory of origin for proper decontamination and disposal. Such transport must comply with the provisions of Section 5 or Section 6, as applicable. The Responsible PI is responsible for such transportation, including all associated expenses.
      4.2. All specimens stored at the DBSF must be decontaminated by off-site autoclaving prior to disposal. Disposal of specimens must be in accordance with the Dartmouth College Exposure Control Program (http://www.dartmouth.edu/~ehs/docs/bsl2exposurecontrol2011.pdf). The Responsible PI and the Permitted User must ensure proper decontamination.

      5. Commercial Transportation of Freezers Containing Specimens To and From the DBSF
      5.1. Transport of an entire freezer and its contents to or from the DBSF MUST be accomplished solely by a licensed commercial carrier. Transportation requirements for the shipping of hazardous goods using a commercial carrier is regulated by the US Department of Transportation (DOT). The Responsible PI must ensure adherence by the carrier to all DOT regulations governing the transportation of hazardous goods.
      5.2. The Responsible PI must ensure compliance with the following:
      5.2.1. Each freezer stocked with specimens for storage must inspected to ensure that (i) all primary and secondary containers within the freezer are capable of sustained deep freeze temperatures without becoming friable and that all primary containers incorporate a leak-proof screw top cap, (ii) the freezer is capable of safe transportation and housing of specimens during transport and (iii) the freezer is locked and labeled according to DOT regulations for shipping of hazardous materials (49 CFR 100-185).
      5.2.2. The transportation company is authorized to transport hazardous material and is aware of all hazards associated with the contents of the freezer.
      5.2.3. No Category A (UN2814) infectious substance is within the freezer during transportation. See http://www.therapak.com/docs/CatAInfSub.pdf for a list of Category A infectious substances.
      5.2.4. Upon arrival at the DBSF, the freezer must be inspected by the Responsible PI, the Laboratory Manager or another Permitted User to confirm that all specimens are in a safe storage condition (i.e. no specimens were compromised during shipping).
      6. Transportation of Specimens Outside of Freezers To and From the DBSF
      6.1. Large (greater than 5 standard freezer boxes) numbers of specimens not within a freezer MUST be transported to and from the DBSF by a courier service retained by the Responsible PI. If needed, the Responsible PI should contact EHS (603-646-1762) for information regarding appropriate packing and transport procedures.
      6.2. Specimens transported to or from the DBSF in personal automobiles must be packaged in a way as to avoid spillage and leakage. The Responsible PI must ensure compliance with the following:
      6.2.1. Primary containers (tubes) and secondary storage containers (freezer boxes) must be capable of withstanding sustained deep freeze temperatures without becoming friable.
      6.2.2. Primary containers (tubes) must incorporate a leak-proof screw top cap.
      6.2.3. Primary and secondary containers must be placed within a shipping container of appropriate materials, size and structural integrity.
      6.2.4. The shipping container referred to in Section 6.2.3 must be placed within a rigid cardboard box capable of safely and securely handling transportation to the DBSF or back to the laboratory of origin.
      6.2.5. The outer box referred to in Section 6.2.4 must be closed securely.
      6.3. The Responsible PI must ensure that all primary and secondary containers referred to in Section 6.2 are labeled with a biohazard sticker, a dry ice sticker (if applicable) and a description of the contents that complies with Section 7.
      6.4. The Responsible PI must ensure that all packaging materials are returned to the laboratory of origin for disposal. DISPOSAL OF SHIPPING/TRANSPORTATION MATERIAL AT THE DBSF IS STRICTLY FORBIDDEN.
      7. Specimen Annotation

      7.1. BEFORE A FREEZER CONTAINING SPECIMENS WILL BE ACCEPTED AT THE DBSF OR BEFORE ANY SPECIMENS NOT TRANSPORTED IN A FREEZER MAY BE STORED IN A FREEZER LOCATED AT THE DBSF, the Responsible PI must provide the DBSF Staff with the following identifying information for each specimen:
      7.1.1. Name of Responsible PI
      7.1.2. Unique Sample Identifier
      7.1.3. Box and Rack or Shelf/Tower Location
      7.1.4. Sample type (Clinical Tissue, Bacterial culture, blood sample, etc.)
      7.1.4.1. Scientific Name (Genus and Species)
      7.1.4.2. Known antibiotic resistance markers
      7.1.4.3. Highest biohazard level of the specimen
      7.1.4.4. Approved IRB study Number ( For human samples)
      7.1.4.5. IACUC Number (For animal samples)
      7.1.4.6. Original date of storage (i.e., date when specimen was first frozen)
      7.1.4.7. Contact information (i.e., email addresses and business and non-business hour phone numbers) of the Responsible PI, the Laboratory Manager and any other person designated by the Responsible PI as a point of contact for matters relating to the DBSF, including the occurrence of freezer alarm incidents

      The foregoing information may be provided in any of the common file formats, i.e., CSV, XML or Tab Delimited text.

      7.2. The DBSF Coordinator is responsible for ensuring that the foregoing information is input to, and maintained in, the DBSF database. The DBSF Staff is responsible for posting such information on the Freezer Specimen Inventory Form clipped to the freezer.

      8. Training

      8.1. Prior to accessing the DBSF for the first time, and thereafter as required, all DBSF Staff, Permitted Users, On-Call List Members, and all other authorized persons accessing the DBSF (other than EHS staff, FOM staff, Risk Management staff, Safety and Security staff and Service Vendors) must complete (i) appropriate training in compliance with OSHA Blood-Borne Pathogen Standard (29 CFR 1910.1030), including completion of the following EHS training modules through BioRAFT: (w) Introduction to Lab Safety, (x) Introduction to BSL-2 Training, (y) BSL-2 Annual Refresher (including blood-borne pathogen training) and (z) Hazardous Waste Management, and (ii) training conducted by the DBSF Coordinator regarding these SOPs and the operations of the DBSF.

      9. Personal Protective Equipment Standards

      9.1. The DBSF Staff must ensure that the DBSF emergency eyewash is accessible and operating at all times. The eyewash must be flushed weekly, with the date of testing noted on the unit.
      9.2. The DBSF Staff must ensure that the following Personal Protective Equipment is available at the DBSF at all times for use by the DBSF Staff, the On-Call List Members and others on the premises who have need thereof (it being understood that Permitted Users and Service Vendors generally are required to supply their own Personal Protective Equipment and the DBSF Staff may deny access to the DBSF to Permitted Users who fail on more than two (2) occasions to supply their own Personal Protective Equipment or to ensure that a Service Vendor has appropriate Personal Protective Equipment):
      9.2.1. Latex or Nitrile gloves
      9.2.2. Glove liners
      9.2.3. Safety Glasses
      9.2.4. Face Shield
      9.2.5. Waterproof insulated cryo–gloves
      9.2.6. Lab coat
      9.3. The DBSF Staff, Permitted Users, the On-Call List Members, all Service Vendors and all others accessing the DBSF must wear closed toe shoes and long pants and utilize Personal Protective Equipment when handling specimens or accessing freezers.

      10. Spills

      10.1. Permitted Users must notify the DBSF Staff immediately of the occurrence of a spill outside the presence of DBSF staff. Permitted Users and the DBSF Staff must notify immediately all other persons in the immediate area of the occurrence of a spill. The DBSF Staff must instruct all such persons to leave the DBSF if they determine that it is required for the health or safety of such persons.
      10.2. The DBSF Staff must determine if a spill is too large to be sufficiently contained and cleaned by on-site personnel, in which event the DBSF Staff must call EHS at 646-1762 and request that it send personnel to the DBSF to conduct containment and clean-up operations.
      10.3. Permitted Users are responsible to clean-up spills for which assistance from EHS is not required. (The DBSF Staff must inform Permitted Users regarding the location of the DBSF Spill Kit.) Permitted Users must take the following actions:
      10.3.1. Alert persons in the immediate area that a spill has occurred.
      10.3.2. Stand away from the spilled material for five (5) minutes to allow any aerosols to settle.
      10.3.3. Wearing a lab coat, nitrile gloves and face shield, cover the spill with absorbent pads from the DBSF Spill Kit.
      10.3.4. Carefully pour a freshly prepared 1 in 10 dilution of household bleach located at the DBSF and designated for such purpose around the edges of the spill working to the center. For large spills, bleach may be added directly.
      10.3.5. Allow a minimum fifteen (15) minute contact time between the spill and the bleach solution.
      10.3.6. Wipe and collect the spill with additional absorbent pads from the DBSF Spill Kit by working from the edges to the center.
      10.3.7. Discard broken glass or other potentially sharp materials, including broken plastic, into a biohazard sharps container located at the DBSF and designated for such purpose. Broken glass or other potentially sharp materials, including broken plastic, should not be picked up directly with the hands. Use mechanical means, such as a brush and dust pan, tongs, or forceps located at the DBSF and designated for such purpose. These items must be decontaminated after contact with the sharps hazards. See Section 10.3.10.
      10.3.8. Clean the spill area again by applying fresh bleach solution and wiping the area with paper towels.
      10.3.9. Place non-sharp spill clean-up waste items, such as absorbent pads obtained from the DBSF Spill Kit and damaged storage boxes, in an autoclave biohazard bag contained in the DBSF Spill Kit.
      10.3.10. Wash and decontaminate with freshly prepared 1 in 10 solution of household bleach all re-usable spill clean-up supplies and return them to their storage location.
      10.4. The Responsible PI, the Laboratory Manager or other Permitted User is responsible for placing the filled medical waste biohazard bags in a secondary container and transporting them to his or her facility for decontamination of the biohazard waste materials contained therein via autoclaving.

      10.5. Permitted Users must notify the DBSF Staff immediately in the event of a spill in a public access area (hallway, elevator, etc.) occurring outside the presence of the DBSF Staff. The DBSF Staff must keep all persons away from the spill and contact EHS immediately at 646-1762 for assistance in containing and cleaning up the spill.

      10.6. When a biohazard sharps container is full, the DBSF Staff should contact EHS for waste removal. The DBSF Staff is responsible to replace the removed container with a new one. The DBSF Staff should restock the DBSF Spill Kit as needed, including replacing absorbent pads and medical waste biohazard bags.

      11. Exposure

      11.1. DBSF Staff, Permitted Users, Members of the On-Call Staff, and all other persons accessing the DBSF who are exposed to potentially infectious materials must:
      11.1.1. Wash contaminated skin thoroughly for ten (10) minutes using povidone iodine solution or an antiseptic soap and copious amounts of water.

      11.1.2. Irrigate contaminated eyes and mucous membranes for fifteen (15) minutes using the DBSF eyewash.

      11.1.3. Notify the DBSF Coordinator, their supervisors and, if a Permitted User, the Responsible PI, of the occurrence of the exposure.

      11.1.4. Seek medical attention; nearby facilities include (i) during business hours, Occupational Medicine at Dartmouth-Hitchcock Medical Center (Monday through Friday, 8:00 a.m. to 5:00 p.m.; 603-653-3850) and Alice Peck Day Memorial Hospital Occupational Health Services (Monday through Friday 7 a.m. to 4:30 p.m.; 603-448-7459) and (ii) outside business hours, the emergency rooms at Dartmouth-Hitchcock Medical Center and Alice Peck Day Memorial Hospital.

      11.2. After receiving medical attention:
      11.2.1. Contact EHS (603-646-1762).
      11.2.2. Download, complete, and return the necessary forms to Risk Management within 24 hours. Such forms may be obtained at http://www.dartmouth.edu/~rmi/rmsclaims/employee-injury-report.html.

      12. Responding to Freezer Alarms

      12.1. The On-Call List Members are responsible for investigating all freezer alarms irrespective of the time of occurrence. Any On-Call List Member may conduct such investigation. Once notice of a freezer alarm has been given to the On-Call List Members, the On-Call List Members are responsible to coordinate among themselves which On-Call List Member will conduct the investigation. It is generally expected that if a freezer alarm sounds during regular business hours and the DBSF Coordinator is at the DBSF during such time, he or she will conduct the investigation. Investigation of freezer alarms must be commenced immediately. The On-Call List Member designated to conduct the investigation must take the following actions and must remain at the DBSF until all such actions have been completed:
      12.1.1. Locate the freezer that has caused the alarm.
      12.1.2. Silence the alarm using the key on the front panel. If the alarm has sounded during business hours, the DBSF Staff may silence the alarm prior to the arrival of the On-Call List Member.
      12.1.3. Record the current freezer temperature on the Freezer Temperature Log located on the freezer and on the DBSF Alarm Response Form located near the entrance to the DBSF. Blank DBSF Alarm Forms are clipped to the back of the Freezer Temperature Log.
      12.1.4. Check whether there is electricity to the freezer – the freezer’s power on/off switch indicator light will be lit if the power is connected. If there is no power to the freezer, check that the power cord is properly plugged in and that the circuit breaker is not tripped. Plug in the power cord or reset the circuit breaker as necessary. Check for other sources of temperature failure, e.g., a door/lid not shut properly, and correct such failure if possible.
      12.1.4.1. DO NOT OPEN THE FREEZER UNLESS THE FREEZER HAS FAILED AND NEEDS TO BE EMPTIED.
      12.1.5. If the freezer temperature reaches the applicable alarm set point (i.e., for -140°C freezers, between -126°C and -154°C; for -80°C freezers, between -72°C and -88°C; for -20°C freezers, between -15°C and -25°C; and for 4°C refrigerators, between 2°C and 8°C) within two (2) hours after the arrival of the On-Call List Member:

      12.1.5.1. Turn the alarm back on.
      12.1.5.2. Report immediately, by email or phone, preferably by email, the incident and actions taken to the DBSF Coordinator and the Responsible PI or applicable Laboratory Person or other person designated by the Responsible PI to be contacted.
      12.1.6. If the freezer temperature does not reach the applicable alarm set point (i.e., for -140°C freezers, between -126°C and -154°C; for -80°C freezers, between -72°C and -88°C; for -20°C freezers, between -15°C and -25°C; and for 4°C refrigerators, between 2°C and 8°C) within two (2) hours after the arrival of the On-Call List Member, follow the procedures set forth in Sections 3.3.10 through 3.3.12.
      12.1.7 Report immediately by email or phone, preferably by email, the incident and the actions taken to the DBSF Coordinator and, if the none of the Responders has responded to the call made by the On-Call List Member under Section 3.3.10.3, to the Responsible PI or the applicable Laboratory Manager.

      12.2. The DBSF Operations Committee may revoke the authorization of any Responsible PI to utilize the DBSF if such Responsible PI or any other Responder associated with such Responsible PI fails on more than two (2) occasions to respond to a request made by an On-Call List Member pursuant to Section 3.3.10.3 to empty a freezer. In such event, such Responsible PI must remove his or her specimens from the DBSF no later than ten (10) business days following receipt of a notice of revocation of such authorization.

      13. DBSF Intrusion

      13.1. Lenel will be notified in the event of an unauthorized intrusion into the DBSF. Lenel will immediately notify Safety and Security, who would then notify the Lebanon police and call the On-Call List Members. The DBSF Staff will provide Safety and Security with a telephone numbers for the On-Call List Members and update such list promptly following any changes thereto.
      14. Fire – USE C.A.R.E.
      14.1. Contain the fire by closing all doors to the area.
      14.2. Activate the nearest fire alarm pull station.
      14.3. Report the fire by dialing 911.
      If the fire is small enough so that it is feasible to extinguish it with one of the fire extinguishers mounted on the walls outside the DBSF entrance, persons on the premises who are trained in the use of fire extinguishers are authorized to retrieve the fire extinguishers and reenter the DBSF to attempt to extinguish the fire if and only if they feel they are not compromising their safety to do so. All other persons should evacuate the premises. If trained personnel determine that it is not feasible to attempt to extinguish the fire or they feel they may be compromising their safety to do so, they should evacuate the premises as well.

      14.4. The sprinkler system is a wet system. The system is activated by heat. It is connected to a Fire Call box on the premises.
      14.5. The Lebanon Fire Department has a call list of Emergency numbers to call in the event of a fire alarm at the Freezer Facility. Emergency numbers are also posted on the door at 56 Etna Road.
      15. Emergency Phone Numbers:
      15.1. See Appendix 1 attached hereto.

    • Dartmouth Biospecimen Storage Facility (DBSF) Operating Policy ( Protocol )

      Operating Policy For The
      Dartmouth Biospecimen Storage Facility (DBSF)
      1. Operator
      1.1. The DBSF is operated by the Geisel School of Medicine at Dartmouth (Geisel) as a Shared Resource. The DBSF is a component of the COBRE Center for Molecular Epidemiology Biorepository Core (Biorepository Core). Day-to-day oversight responsibility for DBSF operations is vested in the Molecular Epidemiology COBRE Biorepository Core Laboratory Manager and staff, of which one person is designated as the DBSF Coordinator. Responsibility for the administration of applications to use the DBSF, compliance and other administrative matters described in this Policy, and the revision of the SOPs (defined in Section 6.1) is vested in the DBSF Operations Committee, a body consisting of Dartmouth faculty and staff approved by, and reporting to, the Provost or his or her designee (Operations Committee). The activities of the Operations Committee are coordinated by the Administrative Coordinator for Shared Resources. Responsibility for billing and revenue collection is vested in the Geisel Central Finance Center.

      2. Scope of Use
      2.1. Only specimens classified as Centers for Disease Control (CDC) containment Biosafety Level 1 or 2, including but not limited to those listed below, (Permitted Specimens) may be stored in the DBSF.
      2.1.1. Human or animal whole blood specimens
      2.1.2. Human or animal urine specimens
      2.1.3. Human or animal tissue( including semen, hair, finger, stool, saliva and toe nails)
      2.1.4. Human or animal tissue sections (biopsies)
      2.1.5. Cell cultures
      2.1.6. Bacterial cultures
      2.1.7. Viral stocks.
      2.2. The DBSF will be operated in compliance with the Occupational Safety and Health Administration Bloodborne Pathogen Standard (29 CFR 1910.1030) and all other applicable laws and regulations.
      2.3. The DBSF may be used solely for long-term storage of Permitted Specimens for future research by Permitted Users (defined in Section 4.1) in connection with ongoing research being conducted at the time of initial storage and described in the application referred to in Section 4.2. Specimens stored at the DBSF cannot be accessed or used by persons who are not engaged in the research described in the application referred to in Section 4.2.
      2.4. At such time as (i) the research study for which Permitted Specimens stored at the DBSF are utilized has terminated or loses funding, (ii) a principal investigator (PI) leading a research study for which Permitted Specimens stored at the DBSF are utilized no longer is employed or engaged by Dartmouth College or no longer holds a Dartmouth College faculty appointment or (iii) the PI is no longer eligible to utilize the DBSF as a result of the revocation of his or her authorization by the Operations Committee, the Permitted Specimens may no longer be stored at the DBSF and must be transferred to another facility or destroyed, in each case in accordance with applicable institutional review board (IRB) requirements, requirements of any applicable funding sources or other applicable contractual requirements, applicable Dartmouth College policies and applicable law. The PI leading the research study shall be responsible for such transfer or destruction, including all expenses associated therewith. This obligation to transfer or destroy the Permitted Specimens shall not apply where otherwise required by applicable funding sources or other applicable contractual or legal requirements or, in case of clause (ii) of the first sentence of this Section 2.4, where an existing or new PI employed or engaged by Dartmouth College or holding a Dartmouth College faculty or other appointment is or becomes the leader of the research study. In such event, the applicable PI shall be responsible for all charges associated with the continued storage of the Permitted Specimens. The Operations Committee will undertake periodic reviews of available information regarding Permitted Specimens stored at the DBSF to identify any Permitted Specimens that must be transferred in accordance with this Section 2.4 and will notify the applicable Permitted Users thereof. The Operations Committee may grant waivers of the requirements of this Section 2.4. Any decision of the Operations Committee denying a request for a waiver may be appealed to the Provost or his or her designee, whose decision with respect to the matter shall be final.

      3. Prohibited Uses or Activities
      3.1. The DBSF is not a research laboratory. Manipulation of, or exposure of personnel to, any biological or chemical materials, including opening specimen containers or handling or storing uncontained biological or chemical materials, is strictly prohibited. Any and all such manipulation or exposure must take place in a research laboratory, not in the DBSF.
      3.2. Without limiting the generality of Section 2.1, storage of any of the following is strictly prohibited:
      3.2.1. Radioactive or radio-labeled materials (radioactive means any material with activity above background radiation levels)
      3.2.2. Hazardous chemicals including flammable, corrosive, reactive or toxic materials (de-minimus volumes of specimen preservative are permitted)
      3.2.3. Select Agents as defined by the United States Department of Agriculture Animal and Plant Inspection Service
      3.2.4. Biological materials classified as CDC containment Biosafety Level 3 or higher.

      4. Permitted Users; Applications to Use the DBSF
      4.1. Use of the DBSF shall be limited to (i) organizations within Dartmouth College, including schools (and departments thereof) and research centers, (ii) individuals employed or engaged as independent contractors by Dartmouth College or holding a faculty or other appointment from Dartmouth College, in each case in connection with research conducted by them or their supervisors within the scope of their employment, engagement or appointment at Dartmouth College, and (iii) other organizations and individuals approved by the Provost or his or her designee upon such terms and conditions approved by him or her (Permitted Users).
      4.2. Any Permitted User desiring to use the DBSF must submit to the Operations Committee an application in the form approved by the Operations Committee; the PI leading a research study shall submit such application on behalf of all study researchers, technicians and other individuals whom the PI desires to be designated as Permitted Users. The PI shall notify the Operations Committee when any individual should no longer be designated as a Permitted User. The PI may submit to the Operation Committee addenda to the application in the form approved by the Operations Committee requesting that additional individuals be designated as Permitted Users. Each application and addendum will be reviewed by the Operations Committee, which may deny approval solely (i) with respect to any individual included as a proposed Permitted User, if such individual does not satisfy the eligibility criteria specified in Section 4.1, (ii) with respect to the applicable research study, if such study does not satisfy the eligibility criteria specified in Section 2.3, or (iii) if the Operations Committee determines that the DBSF does not have sufficient capacity for the requested storage. Any decision of the Operations Committee denying approval may be appealed to the Provost or his or her designee, whose decision with respect to the matter shall be final.

      5. DBSF Service Charges
      5.1. Base and other service charges for the use of the DBSF shall be determined in accordance with the policies applicable to Dartmouth College service centers in effect from time to time.

      6. Standard Operating Procedures; Certifications; Training
      6.1 The DBSF shall be operated in accordance with this Policy, DBSF SOP 001 Comprehensive Standard Operating Procedures and such other standard operating procedures as shall be adopted from time to time in accordance with Section 8.1 (SOPs). The Operations Committee shall maintain current copies of the SOPs and all amendments thereto and shall provide Permitted Users and other Dartmouth College personnel with copies thereof upon request.
      6.2 The DBSF Coordinator is responsible for ensuring that all DBSF personnel read this Policy and all SOPs and certify in writing that they have read and understand them and agree to comply with them. The foregoing must be repeated each time this Policy or any SOP has been revised in a material manner. The DBSF Coordinator is responsible for ensuring that all DBSF personnel complete appropriate training regarding the performance of their duties with respect to the operation of the DBSF.
      6.3 Each PI is responsible for ensuring that such PI and each individual Permitted User working on such PI's research study reads this Policy and all SOPs and certifies in writing that he or she has read and understands them and agrees to comply with them. The foregoing is required prior to the first time a Permitted User accesses the DBSF and must be repeated each time this Policy or any SOP has been revised in a material manner. Each PI is responsible for ensuring that prior to the first time each individual Permitted User working on his or her research study accesses the DBSF, such individual completes appropriate training regarding the use of the DBSF, including without limitation all training relating to laboratory safety or the conduct of research required by other applicable Dartmouth College policies, including policies of the Dartmouth College Office of Environmental Health and Safety. The PI must certify the foregoing in writing to the Operations Committee.
      6.4 All other Dartmouth College personnel who require access to the DBSF in connection with the performance of their duties, including staff of the Dartmouth College Office of Environmental Health and Safety and staff of the Dartmouth College Office of Facilities Operation and Management, must read this Policy and all SOPs and certify in writing that they have read and understand them and agree to comply with them. The foregoing must be repeated each time this Policy or any SOP has been revised in a material manner.

      7. Compliance Monitoring; Sanctions for Non-Compliance
      7.1 The DBSF Coordinator must promptly report to the Operations Committee known or suspected violations of this Policy or the SOPs of which any DBSF personnel is aware. The Operations Committee will attempt to resolve informally with the relevant individual and the applicable PI any such violations that do not involve serious bodily harm, significant property damage or a serious breach of security, or any serious risk thereof (Serious Violations). The Operations Committee may revoke the authorization of a PI or any other Permitted User to utilize the DBSF as provided in any SOP. Known or suspected Serious Violations, or repeated other violations as to which the Operations Committee determines that escalation of review thereof is warranted, shall be referred to the appropriate supervisory personnel and, in the case of PIs, to the Provost or his or her designee, for appropriate action.
      7.2 In the event of a known or alleged violation referred to supervisory personnel or the Provost or his or her designee, as applicable, pursuant to Section 7.2, such supervisory personnel, or the Provost or his or her designee, as applicable, will work with other appropriate Dartmouth personnel in accordance with the regular guidelines and procedures of Dartmouth College regarding possible sanctions to be imposed on a violator. Potential sanctions include, but are not limited to, (i) formal admonition, (ii) a letter from the appropriate supervisory personnel to the person's permanent personnel file, (iii) ineligibility for grants, CPHS or other IRB approval or supervision of graduate students, (iv) non-renewal of appointment, or (v) dismissal.
      7.3 Subject to any applicable requirements of the protocols referred to the following sentence, the final decision regarding sanctions will be made by the Provost or his or her designee. In all cases, imposition of sanctions will occur in accordance with the protocols established pursuant to other applicable Dartmouth College policies, including without limitation protocols established by the Dartmouth College Committee on Academic Freedom and Responsibility.

      8. Composition of the Operations Committee
      8.1 The Operations Committee shall consist of representatives from The COBRE Center for Molecular Epidemiology, the Pathology Department of Geisel School of Medicine, the Norris Cotton Cancer Center, the Dartmouth College Office of Environmental Health and Safety, the Dartmouth College Office of Risk Management, the Dartmouth College Office of Provost and the Office of Facilities Operations and Maintenance of Geisel School of Medicine.

      9. Adoption and Amendment of Policy, Standard Operating Procedures and Forms
      9.1 This Policy, and all related SOPs and forms, will be effective upon approval thereof by the Provost or his or her designee. Amendments of this Policy shall require the approval of one of the persons described in the preceding sentence. Amendments of the SOPs and any forms shall require the approval of the Operations Committee. The Operations Committee may not approve any such amendments that are inconsistent with this Policy.

    • DARTMOUTH BIOSPECIMEN STORAGE FACILITY SERVICE (DBSF) APPLICANTS SUMMARY FACT SHEET ( Protocol )

      DARTMOUTH BIOSPECIMEN STORAGE FACILITY SERVICE (DBSF)
      APPLICANTS SUMMARY FACT SHEET

      The purpose of this fact sheet is to provide prospective DBSF applicants a general summary and orientation to the DBSF and its features, services and conditions of services. Importantly, additional specific details regarding the use and services of DBSF can be found in the DBSF Operating Policy, DBSF SOPs and EHS policies and procedures.

      The DBSF is a Geisel School of Medicine sponsored, shared resource, managed by the COBRE Center of Molecular Epidemiology Biorepository Core. The DBSF mission is to provide Dartmouth College affiliated investigators with a controlled environment for the safe and secure long term storage of freezers, refrigerators (e.g. -140⁰C, -80⁰C, -20⁰C and 4⁰C ) and permitted biospecimens for a monthly freezer service charge.

      A. General conditions of DBSF service:

      1. The DBSF is for long term storage, generally for archival and back up specimens. Access to individual freezers by users is expected to be relatively infrequent. Freezers needing frequent access should not utilize the DBSF as a mechanism for storage.

      2. DBSF use entails a service charge per month for each freezer or refrigerator, regardless of size. Service charge is charged to the applicant/owner of freezer. Service charge payment is mediated through the Geisel Finance Office.

      a. The owner of a freezer may let other researchers who meet the criteria for permitted users set forth in the DBSF Operating Policy users use freezer space in their freezer, but the owner of the freezer is ultimately responsible for the freezer and must provide an appropriate payment account and is responsible for paying service charge.

      b. Freezers failing to pay service charge for whatever means are subject to DBSF use policies which may include remove from facility at owner’s expense.

      c. Owner of freezers are responsible for directly arranging and paying for the movement of their freezers to the DBSF and for the cost of connecting the thermal alarms.

      d. Owners of freezers are responsible for arranging and directly paying for any repairs and maintenance for their freezers.

      3. All DBSF users must specifically apply for approval to use/access the DBSF facility.

      4. All DBSF users must acknowledge understanding and meet all DBSF operation requirements and policies.

      5. DBSF owned freezer and refrigerator space is for temporary back up emergency uses only. The DBSF does not have freezer space for researchers to utilize for general storage.

      6. The DBSF is a restricted access area, limited to DBSF and other designated staff. Use of DBSF facilities for specimen deposit and retrieval, maintenance and repair of freezers, and other issues is by appointment only. The DBSF provides escorted access to biospecimens for approved and trained permitted users by DBSF staff during normal working hours with appointment.

      7. DBSF does not maintain continuous on-site staff presence. DBSF services entail the secure facility, continuous monitoring and emergency response during off duty hours. Equipment and specimen management is the responsibility of users.

      8. DBSF staff provide the following services:

      a. Routine facility operation and maintenance of associated operational logs

      b. Emergency response during off-duty hours to preserve immediate biospecimen integrity

      c. Alert users to other noted non-emergency problems with their freezers

      d. Escorted access to freezers

      e. Assist researchers with connecting their freezers with various monitor systems

      9. DBSF staff DO NOT provide the following services:

      a. Retrieve, ship or accept specimens or equipment for users

      b. Maintain, update or perform quality control on specimen inventories

      c. Defrost or provide any other preventative maintenance or arrange for repair

      d. Arrange for transport of freezers to or should DBSF


      B. DBSF storage features

      1. The DBSF is continuously monitored 24/7 by the Dartmouth College Lenel security system which provides controlled access readers and intruder access alarms to prevent unauthorized ingress to facility and access to biospecimens.

      2. The facility is also equipped with 24/7 real-time and recorded Dartmouth College Lenel security video surveillance cameras inside DBSF facility to establish internal accountability of biospecimens.

      3. All DBSF freezers and refrigerators are required to be physically locked. DBSF staff maintains access to a facility key box containing freezer keys for access to freezers during emergency response.

      4. The facility has redundant 24/7 temperature monitoring with alarms for each freezer and emergency response upon alarm by DBSF staff:

      e. Indirect thermal monitoring through the Dartmouth College Honeywell system thermal alarms

      f. Direct temperature monitoring through the REES temperature monitoring system

      10. The DBSF provides backup freezer and refrigerator storage (e.g. -140⁰C, -80⁰C, -20⁰C and 4⁰C) space for emergency response in case user freezer malfunctions.

      11. Facility is OHSA compliant and meets Dartmouth EHS policies and standards.

      12. The DBSF DOES NOT possess the following features:

      a. DBSF does not have any freezer space available for researchers to store biospecimens long term.

      b. DBSF has no laboratory work areas and no laboratory operations are permissible in the DBSF.

      c. DBSF does not have liquid nitrogen or dry ice or containers for these materials.

      d. The DBSF does not provide users will supplies for adding, retrieving or otherwise managing their freezers, refrigerators or biospecimens. The DBSF will supply wheeled carts and cryogloves to assist researchers in obtaining their biospecimens from freezers, however, all other materials involved in specimen retrieval, including any required PPE, most be brought in by and disposed of by the researcher.


    Last updated: 2015-05-28T16:25:29.512-04:00

    Copyright © 2016 by the President and Fellows of Harvard College
    The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016