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Business Continuity Management of Biobanking Strategies
PD Dr. med. Esther Herpel Institute of Pathology and NCT Tissue bank University Hospital Heidelberg Im Neuenheimer Feld 224, D-69120 Heidelberg
Things always seem to happen when you least
expect them...
2008: Breakdown of an electrical substation in Hannover. As a
consequence bank services like Online-Banking, cash terminals and bank
statement printers of approx. 150 „Sparkasse“ agencies were out of order
nationwide.
2009: Overhauls in a data center were defectively carried out train tickets
could not be sold for hours nationwide, trains were considerably delayed or
were not running at all.
2010: Volcanic eruption in Iceland enormously affected and almost stopped
air traffic throughout Europe for several days completely.
Business Continuity Management
(Notfallmanagement) – A Definition
Function: Business Continuity Management (BCM)
• is a systemic appraoch
• is oriented on the business processes of an institution
• to take precautions in case of emergencies or crisis.
The business continuity management should
examine damage events of the categories
• Malfunction
• Contingency and
• Crisis (in part)
Is challenged
• if events are confined/restricted to the institution itself
• as well as broad/comprehensive crisis/states of emergencies and
catastrophies affect on institution.
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Business Continuity Management – Aims
Since exceptional situations cannot
always be prevented, intervention strategies
limit the severity and extent of damage.
The main goal is
• to prepare the company well for the contingency and
• to reduce the consequences of an contingency to an acceptable level
(response).
• to protect the company against closing down due to excessive losses
caused by an contingency.
• increases survival capability and ensures to react to emergencies most
felxibly.
• intensively fosters identification with implemented processes of an institution
• increases transparency thereby revealing room for improvement for
standard operations
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• Assumption of responsibility and development of guiding principles
for business continuity management.
• Determination of the critical resources and measures and
establishment of the organizational framework within the institution.
• Define preventive measures and their operation to guarantee
immediate restart of essential processes in case of a breakdown.
Prioritizing guiding principles for the implementation of crisis management,
provision of resources, determination of responsibilities, identification of
potential required measures.
Initiation of the Business Continuity Management
Process (Initialisierungsphase)
Development of Continuity Strategies
Examples of organisation-wide strategy options
BSI Standard 100-4: Business Continuity Management (pdf, 1.16 MB)
Minimal
No
Medium
Large
High
Medium to High
Medium
Low
Strategy option/
Solution
Residual risk
analysis
Conception (Konzept)
A contingency plan defines preventive measures
and specifies continuity strategies.
In particular the following questions have do be
addressed:
• Which countermeasures are established to prevent
emergencies?
• Which mechanisms register critical events to
immediately react on a state of emergency?
• Which resources are required to counteract an
emergency operation and how is this process
initiated?
• How is the repatriation into the normal operation
organized?
• Which measures are still required after returning to
the resumption of standard operation?
Perform cost-analysis
Ascertain the priority
Determine person in charge
Arrange associated provisions
Implementation planning
Business Process (Geschäftsprozess)
BSI Standard 100-4: Business Continuity Management (pdf, 1.16 MB)
Contingency Response (Notfallbewältigung)
• The responsibilities, plans and codes of conduct for
responding to and acting in contingencies are laid down
in a business continuity plan.
• Accepting responsibility by management
• Conception and planning of the business continuity management
process
• Fulfilling organisational prerequisites
• Creation of a policy for business continuity management
• Providing resources
• Including all employees
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Business Continuity Handbook (Notfallhandbuch)
Contains all documents required for business continuity response.
• Summarizes the structures, information, measures, and actions
necessary to handle an emergency and recover business operations.
• Including Roles, responsibilities, and authorities
• Reporting paths and escalation
• Immediate measures and instructions for special emergencies
• Arrangements to maintain the business continuity response
• Provisions to instantly restore the standard operation
• Must be specially adapted to the particular organization, its
organizational structure, and its requirements in terms of business
continuity.
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Tests and Exercises
• Tests and practice of contingency
precautions and business continuity
plans to check the operability, identify
possible defects and to train behaviour
in the event of an contingency
Maintenance and Continuous Improvement
• The appropriateness and effectiveness of the concepts and safeguards
are checked at regular intervals. Their evaluation facilitates the
continuous improvement of the business continuity management
process.
Realization & Phases of the Business Continuity
Management Process
https://www.bsi.bund.de/SharedDocs/Downloads/DE/BSI/Mindestanforderungen/English_BCM_Study.html
continuous improvement of the business continuity management process.
• Since the end of 2005 (DKFZ, NCT, University)
• Central and comprehensive organizational structure for research
• Accreditation according to DIN/ISO 17020
• Collection, characterization, registration, archiving and processing of tissues and
their derivatives
• cryo-preserved specimen: > 20.000 donors (each with several samples)
• paraffin archive: > 500.000 samples (Institute of Pathology, Heidelberg
University Hospital)
• Services and technology platform (tissue micro array, virtual microscopy; IHC)
• Compilation of project-specific biomaterial collectives
• Project support: (coordination; management; training; tracking)
• > 1.600 executed projects
• between 10 and > 200 samples/specimen per project application
NCT Tissue Bank
• Do we need a BCM similar to the management
strategies established in companies?
• Can we define business processes in the context of
biobanking?
• Can we generally afford the installation and/or
maintenance of a BCM?
• Which resources and processes would possibly be
affected?
• Which emergencies could be forestalled/hampered by
preventive measures?
Business Continuity Management of the
NCT Tissue Bank
• Accredited QMD is of great benefit/ convenience
• Many guiding, core and support processes that are crucial for BCM are
explicitly designated in the QMD
• Strong fundament
HOWEVER
• Detailed commitment to the topic „BCM“ reveals that it is much more
comprehensive than expected.
Analysis of the current state −
BCM of NCT Tissue Bank
Category
Electricity cut (water, fire) freezers and machines out of order
Pandemia understaffed team
Shortness of consumables/biomaterial
Lack of funding
Loss of ethical vote
Absence of replenishing biomaterial/ confiscation of specimen
(data protection)
Scenario
Impaired ability to perform tasks
Negative internal and external effects (image damage)
A drop in the level of motivation of the employees
Financial consequences
Violations of laws, regulations and contracts
Specification of the damage categories and scenarios
affecting NCT Tissue Bank
• Complete processing of all BCM stages
• Definition and specification of preventive and
reactive emergency measures
• Tests and exercises as well as continuous
improvement strategies of the BCM process
are in principle described
• Facilitation of a BCM, initial installation and
feasibility of continuity strategies, whereas
exact processes are not addressed in depth
BCM of the NCT Tissue Bank − Status Quo
1. Definite labelling of the freezers („superheros“)
2. Access to the laboratory space (deposition of a back up key)
3. Deposition of key to unlock freezers
4. Connection to ZLT (Leitwarte)
5. Provision of empty, compensatory freezer
6. Tank with liquid nitrogen
7. Daily tour through the freezer storage room/ facility
8. Telephone chain
9. Regular training and instruction
General requirements
http://www.comicvine.com/images/1300-3031477
BCM: Ensure preservation of biomaterial – example 1
http://www.freebievectors.com/de/abbildung/28499/clipart-feuer-clip/
• Alarm is activated
• ZLT gets informed automatically
• 24h/7d each week
BCM: Ensure preservation of biomaterial – example 1
• At night pre-check by ZLT
• In case of a non-fixable incident…
• Start of telephone chain
BCM: Ensure preservation of biomaterial – example 1
BCM: Ensure preservation of biomaterial – example 1
technical
assistant
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Worst case scenario:
failure of more than one freezer
technical
assistant
technical
assistant
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BCM: Ensure ongoing project processing – example 2
Avoid image damage because of poor quality and/ or inadequate processing
• Failure of essential technical laboratory
devices usage of back up equipment in
the „entry laboratory“ of the pathological
institute
• Provision of inappropriate biomaterial
collectives Implement suitable QM− and
project management strategies
Avoid image damage because of poor quality and/ or inadequate processing
• IT-System STARLIMS out of order
Access to daily backup version, only some
few samples need to be again recorded.
• Breakdown of hard- and/or software A
backup of the tissue bank drive is copied
even every 2h
BCM: Ensure ongoing project processing – example 2
BCM is:
• worthwhile despite time-consuming
• not to be implemented from one day to the next
• no „one-fits-all“ solution
BCM has to/ should:
• be structured
• consider all substantial events − from the merest to the greatest conceivable incident
• be adjusted to local and individual capabilities
• stay within the limits (avoid overkill)
BUT
BCM is important and should be implemented…
Summary BCM
https://www.bsi.bund.de
"Es kommt nicht darauf an, die Zukunft vorauszusehen, sondern auf die Zukunft
vorbereitet zu sein." Perikles, griech. Staatsmann, 493-429 v. Chr.
Thanks for your attention!
and
representing NCT Tissue bank/ BMBH:
Frau Kynast u. Frau Schmitt
Summary
Literatur: https://www.bsi.bund.de
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• Bjugn R1, Hansen J., Biopreserv Biobank. 2013 (4):202-5. Learning by
Erring: fire!
• Mintzer JL et al., Biopreserv Biobank. 2013 (4):216-20. Preparedness for
a natural disaster: how Coriell planned for hurricane Sandy.
• https://www.bsi.bund.de/EN/Home/home_node.html
• https://www.bsi.bund.de/SharedDocs/Downloads/EN/BSI/Publications/BS
IStandards/standard_100-4_e_pdf.html
• https://www.bsi.bund.de/SharedDocs/Downloads/DE/BSI/Mindestanforde
rungen/English_BCM_Study.html
Summary