Bio Storage Labs & Repository Overview

BioStorage Laboratory Services

and

BioStorage Repository

Protecting Your Valuable Research

MD Route 43 at Crossroads Circle –

Just two miles east of I-95

Comprehensive Security for Primary and

Backup Facilities

•Campuses under overnight police and video surveillance with adequate exterior lighting

•External doors locked; Front door kept open only when main entry area is occupied

•Live-monitored ADT alarm system with keypad code activation & deactivation

•External door sensors and internal motion, heat & smoke detectors

•CMS-monitored facility environmental conditions

•Campuses under overnight police and video surveillance with adequate exterior lighting

•External doors locked; Front door kept open only when main entry area is occupied

•Live-monitored ADT alarm system with keypad code activation & deactivation

•External door sensors and internal motion, heat & smoke detectors

•CMS-monitored facility environmental conditions

Facilities & Infrastructure

•Freezers have individual locks with dedicated internal alarm sensors

•Authorized clients are escorted through storage warehouse and have access restricted to their own samples

•Reserve UPS power, CO2 & liquid N2, and freezer units available at all times

•Freezers have individual locks with dedicated internal alarm sensors

•Authorized clients are escorted through storage warehouse and have access restricted to their own samples

•Reserve UPS power, CO2 & liquid N2, and freezer units available at all times

Equipment

•Spyware/Viral internet & intranet security and update patches

•Computer terminals and servers are ID/password controlled

•Client database login/password changed every 60 days

•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

•Spyware/Viral internet & intranet security and update patches

•Computer terminals and servers are ID/password controlled

•Client database login/password changed every 60 days

•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

IT & Records

Bioprocessing Laboratory with

Class II Biosafety Cabinet

SAMPLE RECEIPT PROCESSING DISTRIBUTION STORAGE

Process Workflow

RECEIPT Examine incoming

samples/packaging

Review paperwork

Scan papers for vital

records

INVENTORY Upload data sheet or

enter sample data into

FreezerPro database

Generate Barcode if

needed

Identify priority (pre-

frozen) samples for

immediate freezer

storage

NO

YES Priority (Prefrozen)

Sample?

Immediate

transfer to

Storage

TESTING & ANALYSIS

Outsourced to University of MD at

Baltimore Translational Research

Lab

Proliferation & cytotoxicity assays

PD & PK analysis

Genotyping

Performed at BioStorage

Laboratory Services

Mycoplasma, Entotoxin, & Sterility

testing

LAB PROCESSING Isolation / Sample aliquoting

Client or BSL-generated SOPs (if

applicable)

Cell culturing & banking

Production of proteins

FREEZER

STORAGE (Client-specified or

BioStorage-

recommended

environment)

Daily CMS

monitoring of

temperature &

freezer status

Regular freezer &

equipment

maintenance

FreezerPro

Database alerts

for low inventory

SHIPPING Obtain packaging &

shipping supplies

Ship specimens packed in

dry ice unless otherwise

requested

Maintain compliance with

DOT & IOTA regulations

REQUEST Receive written request

from Project Manager, PI

or Designee (with written

authorization)

RETREIVAL Maintain sample integrity

throughout retrieval

process

Update database &

inventory

Quality Assurance & Controls

Inventory •Specimen tracking

•Zebra barcode labeling

•Primary & backup database files

Specimen &

Laboratory

Processing

•ISO 9001 & ISO 17025 compliant

•Mycoplasma / contamination testing

•ISBER & NCI Biorepository best

practices

•Aseptic & Sterile Techniques

•Follow DOT, IOTA, & other Federal

shipping regulations

IT &

Information

•User access-controlled servers &

databases

•Primary & backup database files

•Vital records stored by hard copy and

electronically

Facilities &

Equipment

•Continuous freezer monitoring &

maintenance

•24/7 Central Monitoring System (CMS)

HVAC / Environmental Tracking

•Documentation & status tracking

•Automatic phone notification

•Regular equipment calibration

Processes

&

Operations

Quality

Management

Program

SOPs &

Policies

Quality Management Program

•Equipment and/or

facility testing

•Sample Integrity

•Disaster Recovery

& Continuity Plan

Response

•Memoranda of

Understanding

(MOUs) with Key

Partners

•BioStorage

Reorganization

Implement

and monitor

corrective

actions

BioStorage

Executive

Team

QM Planning Team

Identify Lessons Learned

Identify Deficiencies

Identify Needed Resources

Identify Major Updates

Quality

Manager

Approve

corrective

actions

Incorporate changes into revised SOPs,

Policies, and MOUs

Corrective action plan with recommendations for

implementation

Repository Warehouse has

over 1950 square feet of floor space

Storage and maintenance of

BioStorage-owned and

Client-owned Freezers

Storage Capabilities:

Ambient, +4, -20, -80, & -196 degrees

Celcius

Facility and Equipment have 24-Hour

Monitored Security and Alarm Systems

-80 degree Freezers have CO2 backup

capability

Stand-by -80 degree Freezers available

for emergencies

+4 and -20 degree Celsius

Walk-in Cold Rooms

FreezerPro Biospecimen Inventory

Tracking System

• Easily import sample data spreadsheets

• Quickly change location of individual or boxed specimens

Data Importing

• Search by field or keyword

• Graphic display of sample location

• Live querying & “Smart Folders”

Searching

• Maintains live audit trails

• Role-based, multi-layered access to audit reports

Administration & Auditing

• Incorporates barcode labeling, scanning, & verification

• Compatible with Zebra barcoding system

Sample Identification

• Conforms to FDA’s CFR Part 11 regulations for electronic documentation and electronic signatures

Regulatory Compliance

Shipping and Receiving Area

Rear 9’ X 10’ Exterior Loading Dock

Capacity for Large-Scale Delivery and

24-Hour Reserve Power

EVENT NOTIFICATION ACTIVATION RECONSTITUTION OPERATIONS

Business Continuity Program Aligns with

Federal Guidance

SURVEILLANCE

• Communications

• Human Capital

• Specimen inventory

• Database/file integrity

• Contamination

• Equipment status

• Primary & backup

resources

• Capability to implement

continuity plan

• All-Hazards event

planning

FUNCTIONALLY-

RELATED • Delegation of Authority

• Crisis communications

(internal & external)

• IT / Disaster Recovery

• Specimen Recovery

• Database & Vital Records

• Documentation & Lessons

Learned

HUMAN CAPITAL-

RELATED • Order of Succession

• Critical Hiring & other HR

Flexibilities

• Telework

• Social Distancing Incident

impacts BioStorage

operations?

INCIDENT

DEPLOY Specimens & equipment

to backup unit or facility

and/or

TRANSFER Functions to telework or

distant sites

FACILITY-RELATED • Security / Access control

• HVAC / Utility maintenance

• Equipment maintenance &

repair

• Decontamination/

Housekeeping

KEY FUNCTIONS Impact to BioStorage

resolved

Facility, equipment, IT,

and Human Capital able

to support full

operations

RETURN TO

NORMAL

OPERATIONS Return functions &

operations to primary site

Document incident and

response

Review lessons learned

Implement Correction

Plan

Monitor &

re-evaluate impact

NO

YES

Backup Facility – Arbutus, MD

10,000-Gallon Liquid Nitrogen Reserve

Backup Facility Warehouse has

over 2000 square feet of floor space

Backup Facility has standby

-80 and Liquid Nitrogen Freezers

“All-Hazards” Disaster Plan Aligns with

Federal Guidance

Human- or Infrastructure-Related

Earthquake

Flood

Severe Weather

Hurricane

Winter Weather

Tornado

Natural

Key Disaster Scenario:

Freezer Malfunction or Breakdown

SensaPhone Report:

FREEZER

MALFUNCTION

DETECTED

YES

Impact Assessment:

Will malfunction affect

samples?

NO

Monitor

situation

ACTIVATE

CONTINGENCY PLAN For affected samples

Incident Report to

Client:

SAMPLES

SUCCESSFULLY

PRESERVED Disposition details

attached

TRANSFER

SAMPLES Preserve & relocate samples:

Control spread of impact to

unaffected samples

Isolate affected samples

Relocate affected samples to

backup freezer shelf or unit

Create temporary relocation

file in FreezerPro

PERSONNEL Prepared to respond:

Primary—initial response

within 30 minutes

Alternates—two methods to

contact

EQUIPMENT Backup freezer space:

All units—at least 1 shelf

empty

Reserve units—stand-by to

fully activate

RESOLVE DAMAGE Initiate repairs & plan for

return to permanent storage:

Assess cause of problem

Repair or replace freezer

Prepare & implement plan for

restoration of samples

Plan to mitigate future

problems of similar nature

Generate incident report

Preparation

Decision-Making & Communication

Emergency Operations

http://www.jhu.edu/

LABORATORY SERVICES Tanya Y. Ray, MM – President

Tel: 410-247-2500, x203

Email: [email protected]

REPOSITORY SERVICES Richard A. Blood – Vice President

Tel: 410-247-2500, x202

Email: [email protected]

Bio Storage Labs & Repository Overview

Technology

Transcript of Bio Storage Labs & Repository Overview