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.

htt

p:/

/ww

w.c

om

ratio

.com

/krisenm

anagem

ent/

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

htt

p:/

/ww

w.o

rgenda.d

e/ls/d

efa

ult.a

sp?id

=4

02

Which approach is best suited?

• 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

htt

p:/

/ww

w.s

chru

tka

-peukert

.de/K

unden

die

nst.

htm

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.

htt

p:/

/ww

w.r

enodoku.d

e/f

unktio

nen.h

tml

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

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

technical

assistant

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

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

htt

p:/

/ww

w.g

rancanaria

mitro

land.d

e/w

p-c

onte

nt/

uplo

ads/2

01

0/0

2/g

lueh

birne.jp

g

• 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