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.

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.

http://www.comratio.com/krisenmanagement/

Business Continuity Management (Notfallmanagement) – A Definition

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

http://www.orgenda.de/ls/default.asp?id=402

Business Continuity Management – Aims

Which approach is best suited?

Initiation of the Business Continuity Management Process (Initialisierungsphase) •

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.

Development of Continuity Strategies

Strategy option/ Solution

Residual risk analysis

Minimal

High

No

Medium to High

Medium

Medium

Large

Low

Examples of organisation-wide strategy options BSI Standard 100-4: Business Continuity Management (pdf, 1.16 MB)

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

Perform costanalysis

Ascertain the priority

Implementation planning

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?

Determine person in charge

Arrange associated provisions

Business Process (Geschäftsprozess)

BSI Standard 100-4: Business Continuity Management (pdf, 1.16 MB)

• 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

http://www.schrutka-peukert.de/Kundendienst.htm

Contingency Response (Notfallbewältigung)

 Contains all documents required for business continuity response. •

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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

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Immediate measures and instructions for special emergencies

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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.

http://www.renodoku.de/funktionen.html

Business Continuity Handbook (Notfallhandbuch)

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

 continuous improvement of the business continuity management process. https://www.bsi.bund.de/SharedDocs/Downloads/DE/BSI/Mindestanforderungen/English_BCM_Study.html

NCT Tissue Bank •

Since the end of 2005 (DKFZ, NCT, University)

•

Central and comprehensive organizational structure for research

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Accreditation according to DIN/ISO 17020

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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)

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Services and technology platform (tissue micro array, virtual microscopy; IHC)

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Compilation of project-specific biomaterial collectives

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Project support: (coordination; management; training; tracking) • •

> 1.600 executed projects between 10 and > 200 samples/specimen per project application

Business Continuity Management of the 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?

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Can we generally afford the installation and/or maintenance of a BCM?

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Which resources and processes would possibly be affected?

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Which emergencies could be forestalled/hampered by preventive measures?

Analysis of the current state − BCM of NCT Tissue Bank

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Accredited QMD is of great benefit/ convenience

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Many guiding, core and support processes that are crucial for BCM are explicitly designated in the QMD

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Strong fundament

HOWEVER •

Detailed commitment to the topic „BCM“ reveals that it is much more comprehensive than expected.

Specification of the damage categories and scenarios affecting 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

BCM of the NCT Tissue Bank − Status Quo

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Complete processing of all BCM stages

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Definition and specification of preventive and reactive emergency measures

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Tests and exercises as well as continuous improvement strategies of the BCM process are in principle described

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Facilitation of a BCM, initial installation and feasibility of continuity strategies, whereas exact processes are not addressed in depth

General requirements

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

http://www.comicvine.com/images/1300-3031477

BCM: Ensure preservation of biomaterial – example 1

http://www.freebievectors.com/de/abbildung/28499/clipart-feuer-clip/

BCM: Ensure preservation of biomaterial – example 1

• Alarm is activated • ZLT gets informed automatically • 24h/7d each week

BCM: Ensure preservation of biomaterial – example 1

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At night pre-check by ZLT

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In case of a non-fixable incident…

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Start of telephone chain

BCM: Ensure preservation of biomaterial – example 1

technical assistant

http://pinstake.com/preview/http:%7C%7Ccpfrandfontein%5Eco%5Eza%7Cwp%7Cwp-content%7Cuploads%7C2013%7C07%7CPhotoxpress_16483800-thumbs-up-thumbs-down%5Ejpg/

Worst case scenario: failure of more than one freezer

technical assistant

http://icongal.com/gallery/icon/17282/128/alarm_warning_robbery_siren

technical assistant

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

BCM: Ensure ongoing project processing – example 2  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

Summary BCM BCM is: •

worthwhile despite time-consuming

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not to be implemented from one day to the next

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no „one-fits-all“ solution

BCM has to/ should: •

be structured

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consider all substantial events − from the merest to the greatest conceivable incident

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be adjusted to local and individual capabilities

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stay within the limits (avoid overkill)

BUT  BCM is important and should be implemented… 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

Literatur: https://www.bsi.bund.de

http://www.grancanariamitroland.de/wp-content/uploads/2010/02/gluehbirne.jpg

Summary

Summary •

Bjugn R1, Hansen J., Biopreserv Biobank. 2013 (4):202-5. Learning by Erring: fire!

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Mintzer JL et al., Biopreserv Biobank. 2013 (4):216-20. Preparedness for a natural disaster: how Coriell planned for hurricane Sandy.

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https://www.bsi.bund.de/EN/Home/home_node.html

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https://www.bsi.bund.de/SharedDocs/Downloads/EN/BSI/Publications/BS IStandards/standard_100-4_e_pdf.html

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https://www.bsi.bund.de/SharedDocs/Downloads/DE/BSI/Mindestanforde rungen/English_BCM_Study.html