1. BioStorage Laborator y Ser vices
and
BioStorage Repositor y
Protecting Your Valuable Research

2. MD Route 43 at Crossroads Circle –
Just two miles east of I-95

3. Comprehensive Security for Primary and
Backup Facilities
•Campuses under overnight police and video surveillance with adequate exterior
lighting
Facilities & •External doors locked; Front door kept open only when main entry area is occupied
Infrastructure •Live-monitored ADT alarm system with keypad code activation & deactivation
•External door sensors and internal motion, heat & smoke detectors
•CMS-monitored facility environmental conditions
•Freezers have individual locks with dedicated internal alarm sensors
•Authorized clients are escorted through storage warehouse and have access restricted
Equipment to their own samples
•Reserve UPS power, CO2 & liquid N2, and freezer units available at all times
•Spyware/Viral internet & intranet security and update patches
•Computer terminals and servers are ID/password controlled
•Client database login/password changed every 60 days
IT & Records •Confidentiality, protection, and handling of client data & information maintained
according to Federal guidance
•Databases & files regularly backed up to on-site and off-site servers

4. Bioprocessing Laboratory with
Class II Biosafety Cabinet

5. Process Workflow
SAMPLE RECEIPT PROCESSING STORAGE DISTRIBUTION
RECEIPT YES Immediate REQUEST
Priority (Prefrozen)
Examine incoming transfer to Receive written request
Sample?
samples/packaging Storage from Project Manager, PI
Review paperwork or Designee (with written
Scan papers for vital
NO authorization)
records
LAB PROCESSING FREEZER
Isolation / Sample aliquoting STORAGE
Client or BSL-generated SOPs (if (Client-specified or
BioStorage- RETREIVAL
applicable)
Maintain sample integrity
INVENTORY Cell culturing & banking recommended
throughout retrieval
Upload data sheet or environment)
Production of proteins process
enter sample data into
FreezerPro database
Daily CMS Update database &
monitoring of inventory
Generate Barcode if TESTING & ANALYSIS
needed temperature &
freezer status
Identify priority (pre- Performed at BioStorage
frozen) samples for Laboratory Services
immediate freezer SHIPPING
Mycoplasma, Entotoxin, & Sterility
storage Regular freezer & Obtain packaging &
testing
equipment shipping supplies
Outsourced to University of MD at maintenance Ship specimens packed in
Baltimore Translational Research dry ice unless otherwise
Lab requested
Proliferation & cytotoxicity assays FreezerPro Maintain compliance with
PD & PK analysis Database alerts DOT & IOTA regulations
Genotyping for low inventory

6. Quality Assurance & Controls
•Specimen tracking
Inventory •Zebra barcode labeling
•Primary & backup database files
•ISO 9001 & ISO 17025 compliant
•Mycoplasma / contamination testing
Specimen & •ISBER & NCI Biorepository best
Laboratory practices
Processing •Aseptic & Sterile Techniques
•Follow DOT, IOTA, & other Federal
shipping regulations
Processes Quality
SOPs &
& Management
Policies
•User access-controlled servers & Operations Program
databases
IT &
•Primary & backup database files
Information •Vital records stored by hard copy and
electronically
•Continuous freezer monitoring &
maintenance
•24/7 Central Monitoring System (CMS)
Facilities &
HVAC / Environmental Tracking
Equipment •Documentation & status tracking
•Automatic phone notification
•Regular equipment calibration

7. Quality Management Program
QM Planning Team
•Equipment and/or
facility testing Identify Lessons Learned
•Sample Integrity
•Disaster Recovery Identify Deficiencies
& Continuity Plan
BioStorage
Response Quality
Executive
Identify Needed Resources Manager
•Memoranda of Team
Understanding
(MOUs) with Key
Partners Identify Major Updates
•BioStorage Corrective action plan with
Reorganization recommendations for
implementation
Implement
Approve
Incorporate changes into revised SOPs, and monitor
corrective
Policies, and MOUs corrective
actions
actions

8. Repository Warehouse has
over 1950 square feet of floor space

9. Storage and maintenance of
BioStorage-owned and
Client-owned Freezers

10. Storage Capabilities:
Ambient, +4, -20, -80, & -196 degrees
Celcius

11. Facility and Equipment have 24-Hour
Monitored Security and Alarm Systems

12. -80 degree Freezers have CO2 backup
capability
Stand-by -80 degree Freezers available
for emergencies

13. +4 and -20 degree Celsius
Walk-in Cold Rooms

14. FreezerPro Biospecimen Inventory
Tracking System
Data Importing
• Easily import sample data spreadsheets
• Quickly change location of individual or boxed specimens
Searching
• Search by field or keyword
• Graphic display of sample location
• Live querying & “Smart Folders”
Administration & Auditing
• Maintains live audit trails
• Role-based, multi-layered access to audit reports
Sample Identification
• Incorporates barcode labeling, scanning, & verification
• Compatible with Zebra barcoding system
Regulatory Compliance
• Conforms to FDA’s CFR Part 11 regulations for electronic documentation and electronic signatures

15. Shipping and Receiving Area

16. Rear 9’ X 10’ Exterior Loading Dock

17. Capacity for Large-Scale Delivery and
24-Hour Reserve Power

18. Business Continuity Program Aligns with
Federal Guidance
EVENT NOTIFICATION ACTIVATION OPERATIONS RECONSTITUTION
SURVEILLANCE Monitor & HUMAN CAPITAL- KEY FUNCTIONS
re-evaluate impact RELATED
• Communications Impact to BioStorage
• Order of Succession resolved
• Human Capital NO • Critical Hiring & other HR Facility, equipment, IT,
• Specimen inventory Flexibilities and Human Capital able
• Database/file integrity • Telework to support full
Incident • Social Distancing operations
• Contamination
impacts BioStorage
• Equipment status operations? FACILITY-RELATED
• Primary & backup • Security / Access control
resources • HVAC / Utility maintenance
• Equipment maintenance &
• Capability to implement YES
continuity plan
repair RETURN TO
• Decontamination/
• All-Hazards event Housekeeping
NORMAL
planning
DEPLOY OPERATIONS
Specimens & equipment FUNCTIONALLY- Return functions &
to backup unit or facility operations to primary site
RELATED Document incident and
and/or • Delegation of Authority
response
• Crisis communications
Review lessons learned
INCIDENT TRANSFER (internal & external)
Functions to telework or • IT / Disaster Recovery Implement Correction
distant sites • Specimen Recovery Plan
• Database & Vital Records
• Documentation & Lessons
Learned

19. Backup Facility – Arbutus, MD
10,000-Gallon Liquid Nitrogen Reserve

20. Backup Facility Warehouse has
over 2000 square feet of floor space

21. Backup Facility has standby
-80 and Liquid Nitrogen Freezers

22. “All-Hazards” Disaster Plan Aligns with
Federal Guidance
Human- or Infrastructure-Related Natural
Flood
Severe Weather
Hurricane
Winter Weather
Earthquake
Tornado

23. Key Disaster Scenario:
Freezer Malfunction or Breakdown
Monitor
situation
SensaPhone Report:
Impact Assessment: FREEZER
NO
Will malfunction affect MALFUNCTION
samples? DETECTED
YES
TRANSFER RESOLVE DAMAGE
SAMPLES Initiate repairs & plan for
return to permanent storage: Incident Report to
Preserve & relocate samples:
Client:
ACTIVATE Control spread of impact to Assess cause of problem SAMPLES
CONTINGENCY PLAN unaffected samples Repair or replace freezer SUCCESSFULLY
For affected samples Isolate affected samples Prepare & implement plan for PRESERVED
Relocate affected samples to restoration of samples Disposition details
backup freezer shelf or unit Plan to mitigate future attached
Create temporary relocation problems of similar nature
file in FreezerPro Generate incident report
Decision-Making & Communication
EQUIPMENT PERSONNEL
Backup freezer space: Prepared to respond:
All units—at least 1 shelf Primary—initial response Emergency Operations
empty within 30 minutes
Reserve units—stand-by to Alternates—two methods to Preparation
fully activate contact

25. LABORATORY SERVICES REPOSITORY SERVICES
Tanya Y. Ray, MM – President Richard A. Blood – Vice President
Tel: 410-247-2500, x203 Tel: 410-247-2500, x202
Email: tanya.ray@biostorage.net Email: rblood@biostorage.net