Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

This document gives recommendations for the handling, storage, processing and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE   International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 3: Isolierte DNA

Dieses Dokument gibt Empfehlungen zur Handhabung, Lagerung, Verarbeitung und Dokumentation von aus gefrorenem Gewebe bestehendem und für die DNA-Untersuchung vorgesehenem Untersuchungsmaterial während der präanalytischen Phase vor Beginn der molekularen Untersuchung.
Dieses Dokument ist anwendbar auf molekulare in-vitro-diagnostische Untersuchungen, einschließlich im Laboratorium entwickelter Prüfungen, die von medizinischen Laboratorien und Laboratorien der molekularen Pathologie durchgeführt werden, die aus gefrorenem Gewebe isolierte DNA auswerten. Es ist außerdem dafür vorgesehen, von Kunden des Laboratoriums, Entwicklern und Herstellern von In-vitro-Diagnostika sowie Biobanken, Einrichtungen und kommerziellen Organisationen, die biomedi-zinische Forschungen durchführen, und Aufsichtsbehörden angewendet zu werden.
Gewebe, die vor dem Gefriervorgang einer chemischen Vorbehandlung zur Stabilisierung unterzogen wurden, sind nicht durch dieses Dokument abgedeckt.
ANMERKUNG Internationale, nationale oder regionale Bestimmungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus à congélation rapide - Partie 3: ADN isolé

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za hitro zamrznjena tkiva - 3. del: Izolirani DNA

Ta dokument podaja priporočila za obravnavo, shranjevanje, obdelavo in dokumentiranje vzorcev zamrznjenih tkiv, namenjenih za analizo DNK med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi testi, ki jih izvajajo medicinski laboratoriji in laboratoriji za molekularno patologijo, ki ocenjujejo DNK, izoliran iz zamrznjenega tkiva. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, in regulativni organi.
Tkiva, ki so pred zamrzovanjem prestala predobdelavo za kemično stabilizacijo, niso zajeta v tem dokumentu.
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Withdrawn
Publication Date
17-Jul-2018
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
26-May-2021

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SLOVENSKI STANDARD
SIST-TS CEN/TS 16826-3:2018
01-september-2018
0ROHNXODUQHGLDJQRVWLþQHSUHLVNDYHLQYLWUR6SHFLILNDFLMH]DSUHGSUHLVNRYDOQH
SURFHVH]DKLWUR]DPU]QMHQDWNLYDGHO,]ROLUDQL'1$

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes

for snap frozen tissue - Part 3: Isolated DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für schockgefrorene Gewebeproben - Teil 1: Isolierte DNA

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus

préanalytiques pour les tissus à congélation rapide - Partie 3: ADN isolé
Ta slovenski standard je istoveten z: CEN/TS 16826-3:2018
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST-TS CEN/TS 16826-3:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 16826-3:2018
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SIST-TS CEN/TS 16826-3:2018
CEN/TS 16826-3
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
July 2018
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for snap frozen tissue - Part
3: Isolated DNA

Tests de diagnostic moléculaire in vitro - Spécifications Molekularanalytische in-vitro-diagnostische Verfahren

relatives aux processus préanalytiques pour les tissus à - Spezifikationen für präanalytische Prozesse für

congélation rapide - Partie 3: ADN isolé schockgefrorene Gewebeproben - Teil 3: Isolierte DNA

This Technical Specification (CEN/TS) was approved by CEN on 16 April 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to

submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS

available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in

parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16826-3:2018 E

worldwide for CEN national Members.
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Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 General considerations ................................................................................................................................. 9

5 Outside the laboratory .................................................................................................................................. 9

5.1 Specimen collection ........................................................................................................................................ 9

5.1.1 General ................................................................................................................................................................ 9

5.1.2 Information about the specimen donor/patient ................................................................................. 9

5.1.3 Information about the specimen ............................................................................................................ 10

5.1.4 Specimen processing .................................................................................................................................. 10

5.2 Fresh tissue transport requirements.................................................................................................... 11

5.2.1 General ............................................................................................................................................................. 11

5.2.2 Preparations for the transport ................................................................................................................ 11

5.2.3 During transport .......................................................................................................................................... 11

6 Inside the laboratory .................................................................................................................................. 11

6.1 Information about the reception of the specimen ........................................................................... 11

6.2 Evaluation of the pathology of the specimen and selection of the sample(s) ........................ 12

6.3 Freezing of the specimen or sample(s) ................................................................................................ 13

6.4 Storage requirements ................................................................................................................................. 15

6.5 DNA isolation ................................................................................................................................................. 15

6.5.1 General ............................................................................................................................................................. 15

6.5.2 Using commercial kits ................................................................................................................................ 16

6.5.3 Using the laboratory's own protocols ................................................................................................... 16

6.6 Quantity and quality assessment of isolated DNA ............................................................................ 16

6.7 Storage of isolated DNA .............................................................................................................................. 17

Bibliography ................................................................................................................................................................. 18

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European foreword

This document (CEN/TS 16826-3:2018) has been prepared by Technical Committee CEN/TC 140 “In

vitro diagnostic medical devices”, the secretariat of which is held by DIN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

CEN/TS 16826 consists of the following parts:

— Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap

frozen tissue — Part 1: Isolated RNA;

— Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap

frozen tissue — Part 2: Isolated proteins;

— Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for snap

frozen tissue — Part 3: Isolated DNA.

According to the CEN/CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
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Introduction

Molecular in vitro diagnostics, including molecular pathology, has enabled a significant progress in

medicine. Further progress is expected with new technologies analysing nucleic acids, proteins, and

metabolites in human tissues and body fluids. However, integrity of these molecules can change during

specimen collection, transport, storage, and processing, thus making the outcome from diagnostics or

research unreliable or even impossible because the subsequent examination assay will not determine

the situation in the patient but an artificial pattern generated during the pre-examination process.

Therefore, a standardization of the entire process from specimen collection to the DNA examination is

needed. Studies have been undertaken to determine the important influencing factors. This document

draws upon such work to codify and standardize the steps for frozen tissue with regard to DNA

examination in what is referred to as the pre-examination phase.

DNA integrity in tissues can change during processing and storage. Modifications of the DNA molecules

can impact the validity and reliability of the examination test results. Therefore, it is essential to take

special measures to minimize the described DNA changes and modifications for subsequent

examination.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
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1 Scope

This document gives recommendations for the handling, storage, processing and documentation of

frozen tissue specimens intended for DNA examination during the pre-examination phase before a

molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examination including laboratory

developed tests performed by medical laboratories and molecular pathology laboratories that evaluate

DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro

diagnostics developers and manufacturers, biobanks, institutions and commercial organizations

performing biomedical research, and regulatory authorities.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in

this document.

NOTE International, national or regional regulations or requirements can also apply to specific topics

covered in this document.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN ISO 15189:2012, Medical laboratories — Requirements for quality and competence (ISO 15189:2012,

Corrected version 2014-08-15)

EN ISO/IEC 17020:2012, Conformity assessment — Requirements for the operation of various types of

bodies performing inspection (ISO/IEC 17020:2012)
ISO 15190, Medical laboratories — Requirements for safety
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN ISO 15189 and the following

apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
aliquot

portion of a larger amount of homogenous material, assumed to be taken with negligible sampling error

Note 1 to entry: The term is usually applied to fluids. Tissues are heterogeneous and therefore cannot be

aliquoted.

Note 2 to entry: The definition is derived from the Compendium of Chemical Terminology Gold Book.

International Union of Pure and Applied Chemistry. Version 2.3.3., 2014; the PAC, 1990,62,1193 (Nomenclature

for sampling in analytical chemistry (Recommendations 1990)) p. 1206; and the PAC 1990, 62, 2167 (Glossary of

atmospheric chemistry terms (Recommendations 1990)) p. 2173.
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3.2
ambient temperature
unregulated temperature of the surrounding air
3.3
analyte
component represented in the name of a measurable quantity
[SOURCE: EN ISO 17511:2003, 3.2, modified — The example was not taken over.]
3.4
analytical test performance

accuracy, precision, and sensitivity of a test to measure the analyte of interest

Note 1 to entry: Other test performance characteristics such as robustness, repeatability can apply as well.

3.5
cold ischemia

condition after removal of the tissue from the body until its stabilization or fixation

3.6
diagnosis

identification of a health or disease state from its signs and/or symptoms, where the diagnostic process

can involve examinations and tests for classification of an individual's condition into separate and

distinct categories or subclasses that allow medical decisions about treatment and prognosis to be

made
3.7
DNA
deoxyribonucleic acid

polymer of deoxyribonucleotides occurring in a double-stranded (dsDNA) or single-stranded (ssDNA)

form
[SOURCE: EN ISO 22174:2005, 3.1.2]
3.8
DNase
deoxyribonuclease
enzyme that catalyzes the degradation of DNA into smaller components
3.9
examination
analytical test

set of operations having the object of determining the value or characteristics of a property

Note 1 to entry: Processes that start with the isolated analyte and include all kinds of parameter testing or

chemical manipulation for quantitative or qualitative examination.

[SOURCE: EN ISO 15189:2012, 3.7, modified — The term and definition are used here without the

original notes.]
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3.10
grossing
gross examination

inspection of pathology specimens with the bare eye to obtain diagnostic information, while being

processed for further microscopic examination
3.11
homogeneous
uniform in structure and composition
3.12
interfering substance

endogenous substance of a specimen/sample or exogenous substance (e.g. stabilization solution) that

can alter an examination result
3.13
pre-examination process
preanalytical phase
preanalytical workflow

process that start in chronological order, from the clinician’s request and include the examination

request, preparation and identification of the patient, collection of the primary sample(s),

transportation to and within the medical or pathology laboratory, isolation of analytes, and ends when

the analytical examination begins

Note 1 to entry: The pre-examination phase includes preparative processes that influence the outcome of the

intended examination.

[SOURCE: EN ISO 15189:2012, 3.15, modified — An additional term was added and details were

adjusted to the scope of this document.]
3.14
primary sample
specimen

discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or

more quantities or properties assumed to apply for the whole

[SOURCE: EN ISO 15189:2012, 3.16, modified — The term and definition are used here without the

original notes.]
3.15
proficiency test

evaluation of participant performance against pre-established criteria by means of inter-laboratory

comparisons

[SOURCE: EN ISO/IEC 17043:2010, 3.7, modified — The term and definition are used here without the

original notes.]
3.16
room temperature
for the purposes of this document, temperature in the range of 18 °C to 25 °C
Note 1 to entry: Local or national regulations can have different definitions.
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3.17
sample
one or more parts taken from a primary sample
[SOURCE: EN ISO 15189:2012, 3.24, modified — The example was not taken over.]
3.18
stability

ability of a sample material, when stored under specified conditions, to maintain a stated property value

within specified limits for a specified period of time
Note 1 to entry: The analyte for the purpose of this document is DNA.

[SOURCE: ISO Guide 30:2015, 2.1.15, modified — The words “reference material” were replaced by

“sample material”.]
3.19
storage

prolonged interruption of the preanalytical workflow of a sample or analyte respectively, or of their

derivatives e.g., stained sections or tissue blocks, under appropriate conditions in order to preserve

their properties

Note 1 to entry: Long-term storage typically occurs in laboratory archives or in biobanks.

3.20
validation

confirmation, throughout the provision of objective evidence, that the requirements for a specific

intended use or application have been fulfilled

Note 1 to entry: The term “validated” is used to designate the corresponding status.

[SOURCE: EN ISO 9000:2015, 3.8.13, modified — Note 1 and Note 3 were not taken over.]

3.21
verification

confirmation, through provision of objective evidence, that specified requirements have been fulfilled

Note 1 to entry: The term “verified” is used to designate the corresponding status.

[SOURCE: EN ISO 9000:2015, 3.8.12, modified — Note 1 and Note 2 were not taken over.]

Note 2 to entry: Confirmation can comprise activities such as:
— performing alternative calculations,

— comparing a new design specification with a similar proven design specification,

— undertaking tests and demonstrations, and
— reviewing documents prior to issue.
3.22
warm ischemia

condition before the tissue is removed from the body, but where it is deprived of its normal blood

supply
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3.23
workflow
series of activities necessary to complete a task
4 General considerations

For general statements on medical laboratory quality management systems and in particular on

specimen collection, reception and handling (including avoidance of cross contaminations)

see EN ISO 15189:2012, 4.2, 5.4.4, 5.4.6 or EN ISO/IEC 17020:2012, Clause 8 and 7.2. The requirements

on laboratory equipment, reagents, and consumables according to EN ISO 15189:2012, 5.3 shall be

followed; EN ISO 15189:2012, 5.5.1.2 and 5.5.1.3 and EN ISO/IEC 17020:2012, 6.2 can also apply.

All steps of a diagnostic workflow can influence the final analytical test result. Thus, the entire workflow

including biomolecule stability and sample storage conditions shall be verified and validated. Workflow

steps which cannot always be controlled (e.g. warm ischemia) shall be documented. A risk assessment

of non-controllable workflow steps including their potential impact on the analytical test performance

shall be performed and mitigation measures shall be established to enable the required analytical test

performance.

In contrast to RNA or proteins, DNA in tissue is relatively stable during warm and cold ischemia.

Changes of DNA sequence or copy numbers (e.g. comparative genomic hybridization (CGH) profiles)

due to longer warm and cold ischemia durations are unknown [6]. However, DNA methylation patterns

may change in response to ischemia. [7] The duration until the specimen is frozen should be kept as

short as possible in order to avoid enzymatic degradation of DNA. The duration before freezing shall be

documented and the temperature before freezing should be documented [6].

Safety requirements on specimen transport and handling shall be considered (see EN ISO 15189:2012,

5.2.3 and 5.4.5 and ISO 15190).

During the whole pre-examination process, precautions shall be taken to avoid cross contamination

between different specimens/samples, e.g. by using single-use material whenever feasible or

appropriate cleaning procedures between processing of different specimens/samples.

If a commercial product is not used in accordance with the manufacturer's instructions, responsibility

for its validation, verification, use and performance lies with the user.
5 Outside the laboratory
5.1 Specimen collection
5.1.1 General

For the collection of the specimen, the requirements (e.g. disease condition, specimen size) for the

intended molecular examination (see also Clause 6) should be considered.
See also EN ISO 15189:2012, 5.4.4.
5.1.2 Information about the specimen donor/patient

The documentation shall include the ID of the specimen donor/patient, which can be in the form of a

code.
The documentation should include, but is not limited to:

a) the relevant health status of the specimen donor/patient (e.g. healthy, disease type, concomitant

disease, demographics (e.g. age and gender);
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b) the information about routine medical treatment and special treatment prior to tissue collection

(e.g. anaesthetics, medications, surgical or diagnostic procedures);
c) the appropriate consent from the specimen donor/patient.
5.1.3 Information about the specimen
The documentation shall include, but is not limited to:

a) the start of ischemia within the body (warm ischemia) by documentation of the ischemia-relevant

vessel ligation/clamping time point (usually arterial clamping time);
NOTE Not needed where small tissue biopsy resection for freezing is performed.

b) the time and date when tissue is removed from the body and the method of removal (e.g. core-

needle biopsy, resection, biopsy device used for the collection);

c) the description of tissue type and origin, tissue condition (e.g. diseased, unaffected by the disease),

including references to any marking applied in or outside the operating theatre made by surgeon,

radiologist or pathologist;

If the freezing of the tissue is performed outside the laboratory, the documentation steps described

under 6.2, where pathology evaluation is required, and 6.3 shall be performed.

The documentation should also include the ID of the responsible person collecting the specimen.

5.1.4 Specimen processing

Tissue(s) that need to be frozen for diagnostic purposes can originate from a large specimen or can be

small specimen(s) e.g. biopsies taken by endoscopy or taken from patients during a surgical procedure

where fast frozen section diagnosis is required.

1) Any additions or modifications to the specimen after removal from the body (e.g. labelling for the

orientation of the specimen (e.g. ink-marking, stitches, incision(s)) shall be documented.

Where a pathology diagnosis is required on the specimen, sampling shall be performed by or under

supervision or guidance of a medically qualified (e.g. board certified) pathologist (see 6.2).

Where the specimen was removed without the requirement of pathology diagnosis, the evaluation,

selection and documentation of specimens may be done by other qualified persons than

pathologists.

2) The freezing of the specimen or samples taken from the specimen can be performed outside the

laboratory or inside the laboratory.

Cold ischemia can influence the DNA pattern (e.g. fragmentation); therefore immediate freezing

according to 6.3.2 should be preferred.

a) In case the specimen or sample is frozen outside the laboratory, proceed with 6.2 without

delay.

b) In case the specimen or sample is frozen inside the laboratory, fresh tissue specimens need to

be transported to the laboratory. The steps described under 5.2 for fresh tissue transport shall

be performed without delay.
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5.2 Fresh tissue transport requirements
5.2.1 General

Where transport of the specimen or sample to the laboratory is required for freezing, the laboratory in

partnership with the clinical or surgery department shall establish a protocol for the transport

procedure of the specimen.
5.2.2 Preparations for the transport
The following steps shall be performed:

a) the selection and use of containers and packages (e.g. cooling box, box for storing and

transportation, vacuum packaging);
NOTE 1 This will be in accordance with applicable transport regulations.

b) the selection and use of stabilization procedures (e.g. cooling methods) for transport;

NOTE 2 Accidentally freezing of the fresh tissue (e.g. by using cool packs incorrectly) can lead to DNA

degradation when the tissue thaws. It can also impact the morphological characterization.

c) the labelling of the container (e.g. registration-number, barcode, specimen type, quantity, and organ

tissue of origin) and additional documentation (information as specified in 5.1.2, 5.1.3, 5.1.4, and

5.2.2, a) to b)).

A single container may only contain several specimens, if these specimens come from the same location

(i.e. similar or corresponding anatomical or histological organ parts) and have the same macroscopic

features such as tissue type and disease status (e.g. inflammation, tumour, necrosis).

NOTE 3 Specimens that have the same macroscopic features can have different molecular features.

After removal from the body, specimens should be transferred without delay into the container. The

container should then be kept on wet-ice or at 2 °C to 8 °C in order to minimize changes to the DNA (e.g.

fragmentation).

The temperatures of the collection container's surroundings during cold ischemia (e.g. temperatures in

different rooms, transport) should be documented. If the temperature is not measured, the temperature

range should be estimated by classification as ambient temperature, room temperature, or at 2 °C to

8 °C.
5.2.3 During transport
Temperature monitoring should be applied in a suitable manner.

If the specimen is not already frozen, it should be transported on wet-ice or at 2 °C to 8 °C without delay

in order to minimize changes to the DNA.

The compliance with the protocol for the transport procedure shall be documented. Any deviations

from the protocol shall be described and documented.
6 Inside the laboratory
6.1 Information about the reception of the specimen

The name of the person receiving the specimen shall be documented. The specimen arrival date and

time and conditions (e.g. labelling, transport conditions including temperature, tissue type and number

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of specimens, leaking/breaking of the container) of the received specimens shall be documented. Any

deviations from the established protocol for the transport procedure (see 5.2) shall be documented.

The correct identity of the specimen shall be checked. This should include the clinical information

(see 5.1.2 and 5.1.3) of the specimen (e.g. type, size, number), hospital admission number and/or

donor/patient ID, name of the patient, date of birth of the patient and type of tissue.

6.2 Evaluation of the pathology of the specimen and selection of the sample(s)

The evaluation and documentation of the pathology of the specimen and the selection of the sample(s)

from the specimen for further processing shall be done by or under supervision or responsibility of a

medically qualified (e.g. board certified) pathologist.
Local, national or regional regulations may apply.
Options to select the sample(s) for DNA examination:

a) The selection of appropriate parts of the specimen for molecular and histopathological

examinations as well as for optional further research purposes shall be done by or under

supervision of a medically qualified (e.g. board certified) pathologist to ensure that the collection of

the sample for DNA examination does not compromise the histopathological analyses.

For molecular examination, suitable tissue parts should be selected, whereas parts potentially

compromising the molecular examination, such as bleeding and necrotic parts, should be avoided

where appropriate. Microdissection of tissue should be considered to select or enrich for certain

cellular features of a disease.

NOTE 1 Depending on local procedures, the selection of appropriate parts of the specimen can also be

done outside of the laboratory, e.g. in the operating theatre (see 5.1.4).

In the context of macroscopic evaluation of the surgical specimen the correct identity of the

specimen shall be checked before and/or after fr
...

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