Bio Storage Labs & Repository Overview
- 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