AS LAB C7.2 Requirements for Minimising Errors in Medical Histology Laboratories.pdf

Medical Testing Laboratory
Accreditation Programme
Requirements for
ry
Minimising Errors in
Medical Histology
Laboratories
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supplementary criteria
for accreditation

Medical Testing Laboratory Accreditation
Programme

Requirements for Minimising Errors
in Medical Histology Laboratories

First edition September 2019

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Requirements for Minimising Errors in Medical Histology Laboratories

supplementary criteria for accreditation
Medical Testing Laboratory Accreditation Programme
Requirements for Minimising Errors in Medical Histology Laboratories
AS LAB C7.2

Edition Statement
Edition  Amendment
Date of Issue
ISBN No.
1
New publication. Previously
September 2019
987-1-877531-65-1
Appendices in AS LAB C7.

Published by:
International Accreditation New Zealand
626 Great South Road, Ellerslie, Auckland 1051
Private Bag 28908, Remuera, Auckland 1541, New Zealand
Telephone 64 9 525 6655
Facsimile 64 9 525 2266
Email: [IANZ request email]
Internet: www.ianz.govt.nz
© Copyright International Accreditation New Zealand 2019

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Requirements for Minimising Errors in Medical Histology Laboratories

1
Introduction
1.1
International  Accreditation  New  Zealand’s  (IANZ)  Supplementary  Criteria  provide  supplementary
information to the General Criteria and Specific Criteria for Accreditation for specific types of testing activities.
They provide detail or add extra information to the generally stated requirements of IANZ General Criteria
for Accreditation and IANZ Specific Criteria for the particular field.
1.2
This supplementary criteria details the specific requirements covering the accreditation  of medical
testing laboratories carrying out histology examinations within their scope of accreditation.
1.3
This is a supplementary document to IANZ Specific Criteria 7 (AS LAB C7) which includes general
requirements for medical testing laboratories. This document must be read in conjunction with the current
issues of the following standards and IANZ publications:
(a)
ISO 15189 Medical laboratories — Requirements for quality and competence
(b)
Specific Criteria for Accreditation: Medical Testing (AS LAB C7)
(c)
Procedures and Conditions of Accreditation (AS1)

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Requirements for Minimising Errors in Medical Histology Laboratories

2
Requirements for Minimising Errors in Medical Histology Laboratories
2.1
Key
Minimum Requirements
Specific Criteria with which laboratories will need to demonstrate compliance.
Best Practice
These are not conditions for accreditation but may result in recommendations.
Suggestions/Options
It should be noted that the items in green are suggestions/options from literature that laboratories worldwide have adopted to minimise errors and as such are only
considerations for laboratories in New Zealand to appraise.
It is important to note that some of these checking systems will be incorporated if a tracking system has been implemented in the laboratory as some of these steps
are inherent in such systems. Similarly, points regarding tracking systems are not applicable to laboratories with only manual systems in place.
It should be emphasised that tracking systems and barcoding are all optimal solutions, however these cannot be made compulsory so all aspects must be considered
for laboratories whether using manual or tracking systems.
It is worth noting that before tracking systems are introduced a robust manual system must first be in place.
2.2
Overarching Requirements
Minimum requirements are the same regardless of whether a manual or an automated tracking system is in place. The processes utilised to achieve these
requirements may differ between a manual and an automated tracking system.

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Requirements for Minimising Errors in Medical Histology Laboratories

The following are minimum requirements:
Staffing, training and competency:
  The laboratory has appropriate FTE and skill mix to safely manage workload.
  Staff must be trained and competent for the tasks they perform.
  Detailed and robust training/supervision for all new staff members with comprehensive training and on-going competency records.
  Comprehensive  training  and  on-going  competency  records  are  available  for  pathologists  and  laboratory  staff  performing  cut-up  with  attestation  of
competency by a suitable/relevant person
Processing tasks:
  Single piece work flow.
  Identification of the staff member handling each specimen at each step in processing is recorded.
Non-conformances and incident investigation:
  Non-conformances are documented and addressed as they are noted.
  Any  relevant  discrepancies  noted  during  the  procedures,  including  pre-laboratory  issues  and  inadequate  labelling,  are  incorporated  as
cautionary/explanatory notes in the final authorised report.
  All incidents are identified, recorded and managed, including near misses, in line with organisational policies and procedures to detect trends and as a
preventative measure and inclusion of root cause analysis where required.
  All records such as logs/schedules/audit trails are referenced and included as part of the investigation into incidents.
  There is a mechanism for feedback and follow-up of discrepant histology findings.
  Notification to the appropriate relevant authority of all critical events for review.
Histology facilities:
  Ventilation and extraction systems must be fit for purpose to ensure safe working conditions and air quality checks are performed periodically.
  Segregation of cut-up from other tasks to minimise distractions.
  Controlled working environment with minimisation of distractions and interruptions during all processing steps.

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Requirements for Minimising Errors in Medical Histology Laboratories

2.3
Requirements by Histology Processing Tasks
Task
Minimum Requirement
Best Practice
Options/Suggestions
ACCESSIONING
  Two independent checks to ensure that
  Introduction of a LIS barcode tracking
  Using one specimen number for the
specimen and request form details
system or third party workflow system
entire process rather than a registration
match, including reconciliation between
from registration through to reporting.
and a histology accession number.
the registration and accession number
  Specimens of the same tissue type are
where applicable.
separated so they are not sequential or if

(CRITICAL CONTROL POINT)
this is not possible, implement a process
  Single piece flow accessioning where
that separates the cases.
one case is removed from the specimen
  Capture any additional
bag, checked, labelled and completed,
annotation/notes/reports/images with the
before the next case is started.
request form/documentation post
  Minimum labelling requirements of
registration. Scan and save all related
specimens are adhered to prior to
documents including the request form
processing of the specimen/s.
again if it was used to add notes at

cutup.

At least two identifiers attributable to the
patient that match between specimen/s
and request form.
  Specimens with similar or same
surnames are separated.
GROSSING /
  A segregated room/area with ventilation
  The use of phones restricted to work-
  Labelling of consecutive specimens with
CUT-UP
for formalin fume extraction for cut-
related calls/consultations ONLY.
alternating colours using approved
up/grossing.
Automated verification of cassettes at
diluted marking ink and the colour

cut-up.
recorded on the request form.

Effective physical separation between
specimens.
  Single piece workflow Cassette/s
  Inking core biopsies inked at cut-

labelled as being cut-up/grossed rather
up/grossing station with differing colours

Patient request form image or hard copy
than pre-labelled.
by adding ink to the formalin solution and
must be accessible for checking.
the colour recorded on the request form.
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Requirements for Minimising Errors in Medical Histology Laboratories

Task
Minimum Requirement
Best Practice
Options/Suggestions
  Specimen barcode scanned into the LIS
  If the laboratory is utilising an automated    Additional specimen identification on the
rather than manually entered.
system the barcode labels generated
cassette/s such as specimen type or

need to include at least a two ‘human
type of procedure.

Confirmation that the specimen and
readable’ unique identifiers.
request details match.
  Repeat dictation of registration and/or
accession number, the patient name and
block designation from the cassette in
addition to the initial dictation from the
specimen.
  One specimen/pot grossed/opened at a
time.
  Before cup-up, three-way check that all
details match on specimen pot, cassette
and request form and against the
tracking system if one is used.

(CRITICAL CONTROL POINT)
  Minimum labelling requirements for
cassettes are adhered to prior to
processing of specimen/s.
  At least two unique identifiers that
match between cassette/s, specimen/s
and request form.

NOTE: If the surname is used as one

of the unique identifiers it must include

as many characters as possible.
  Designated area for cut-up/grossing.
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Requirements for Minimising Errors in Medical Histology Laboratories

Task
Minimum Requirement
Best Practice
Options/Suggestions
  If the area is shared with other activities,
ensure that entry by other staff members
is restricted during cut-up/grossing.
EMBEDDING
  One cassette opened at a time for

transfer of tissue.

(CRITICAL CONTROL POINT)
  A system for recording embedding
discrepancies is in place.
MICROTOMY /
  Effective physical separation between
  Complete cases to be cut by one person.     Clear process to manage incomplete
CUTTING /
cases that require isolation / interruption

sectioning of a case – perhaps due to
SECTIONING

Slides are labelled as cut for each case
to workflow, such as decal or cooling
block warming etc.
rather than pre-labelled slides.
from other cases and those that are work
in progress.
  Scanning of the block barcode for LIS

(CRITICAL CONTROL POINT)
initiated microtomy/cutting/sectioning

instructions for each case with the ability

Labels that are pre-printed must not be
to specify the number of slides required.
affixed to slides until the case is being
cut.
  If the laboratory is utilising an automated

system the barcode labels generated

Slides should only be labelled once with
need to include at least two ‘human
labels that will survive subsequent
readable ‘unique identifiers.
staining processes rather than labelled
with a new/different label at the booking-
up/issuing/case assembly step.
  Tissue sections are cleared from the
water bath between each block cut.
  Minimum labelling requirements for
slides are adhered to. At least two
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Requirements for Minimising Errors in Medical Histology Laboratories

Task
Minimum Requirement
Best Practice
Options/Suggestions
unique identifiers that match between
slide, block and request form.

NOTE: If the surname is used as one of

the unique identifiers it must include as

many characters as possible.
  Alterations to original labelling must be
traceable.
  No answering of cell phones or taking
telephone calls while performing
microtomy / cutting / sectioning.
BOOKING UP /
  Correlation of request form details to the    Like specimens of the same tissue type

ISSUING / CASE
slide/s and the macro appearance of the
are physically separated.
ASSEMBLY
block to the corresponding slide and
check against the LIS/Tracking system if
one is in use.

(CRITICAL CONTROL POINT)
  Specimens with similar or same
surnames are separated.
MICROSCOPY
  Policy/Procedure in place for
  Implementation of barcode initiated

confirmation of patient’s specimen and
reporting for pathologists. Must include a
request form prior to examination of
3 way check with the request form, slide
slides.
and LIS.

(CRITICAL CONTROL POINT)
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Requirements for Minimising Errors in Medical Histology Laboratories

3
Histology Incidents – Identification, Management, Reporting &
Monitoring

Ratified by NZ Medical Laboratory Quality Managers’ Group, 20 June 2014
3.1
Incident Category
Error occurred at:

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Error Type:

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P
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1  Labelling Error
1a
1b
1c
1d
1e
1f
1g
2  Specimen
  Transposition/
2a
2b
2c
2d
2e
2f
2g
  Mismatch
3  Specimen Loss
3a
3b
3c
3d
3e
3f
3g
4  Reporting Error
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3.2
Severity / Action Matrix
Consequence
Action
Pre-reporting - Specimen recoverable
Near Miss/ Minor:
and/or clinical management NOT
Manage through team level review and improvement
impacted
processes
Pre-reporting - Specimen unrecoverable
Moderate / MAJOR:
and/or clinical management impacted
Escalate to senior management. Detailed investigation/
Root Cause Analysis required
Post-reporting - Clinical management
Moderate:
NOT impacted
Escalate to senior management. Detailed investigation
required
Post-reporting - Clinical management
MAJOR:
impacted
Escalate to senior management. Detailed investigation/
Root Cause Analysis required

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