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(2021) 11,
Vol. 11,
(2023) Vol. 1790
2027 --- 1803
13, 1790 1803
2028
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Letter to Article
Original
Original the Editor
Article

Study
ISO of histomorphological
15189:2022; what’s new spectrum
in new? of eyelid
lesions
Santosh Pradhan , Keyoor Gautam , Vivek Pant 1 2 1

1
Department of Clinical Biochemistry, Samyak Diagnostic Pvt.Ltd, Lalitpur, Nepal
Reshmi
Reshmi Shrestha
Department of Shrestha
2
Pathology, 11, Diagnostic
Gita Sayami
, Gita
Samyak Sayami 22
Pvt.Ltd, Lalitpur, Nepal

1
Department of
of Pathology,
Pathology, Nepalese
Nepalese Army
Army Institute
Institute of
of Health
Health Sciences,
Sciences, Kathmandu,
Kathmandu, Nepal
Nepal
1
Department
2
Department of Pathology; Hospital for Advanced Medicine and Surgery, Kathmandu, Nepal
2
Department of Pathology; Hospital for Advanced Medicine and Surgery, Kathmandu, Nepal
Dear Editor, contains requirements for the medical laboratory to plan
and implement actions to manage risks and opportunities
The 4th edition of ISO 15189, ABSTRACTMedical Laboratories – for improvement. Benefits of this document’s approach
Keywords: ABSTRACT include: increasing the effectiveness of the management
Keywords: for Quality and competence, has been
Requirements Background:
Background: Eyelid
Eyelid pathologies
pathologies are the most common
system, common surgical
decreasing specimens
thespecimens
probability encountered
of invalid among all of
results, of and
the
Benign; on December 2022.
published
Benign; The first
ophthalmic lesionsversion of theare
and constitute
constitute
the
a wide
most
wide range
range of
of diseases
surgical
diseases by
by their
their unique
encountered
unique histologic
among
histologic features.
all
features. This
This study
the
study
Eyelid lesions;
document lesions; ophthalmic
was issued in 2003. In to
2007,
lesions and a reducing potential harm to patients, laboratory personnel,
Eyelid aims
aims find it
to find outwas
out the revised
the
and
histopathological
histopathological spectrum of
spectrum of eyelid
eyelid lesions,
lesions, their
their demographic
demographic distribution,
distribution, andand
Malignant;
Malignant;
was aligned to ISO/IEC 17025. 1
Third
preferential edition
locationwas published
prevalent in our
the public, and
community.
the environment. This document is intended
Sebaceous carcinoma;
carcinoma; preferential location prevalent in our community. for use in medical laboratory disciplines, including Point-
inSebaceous
2012, which added certainMaterials
sections and including
Methods: laboratory
This is
is an
an observational
observational study in
in which
which we retrospectively
retrospectively evaluated the
the data ofof
information management.2 692 Materials
The and
new Methods:
edition, This
ISO of-Care Testing
study (POCT) we supporting services;
evaluated however,
data
patients retrieved from the histopathology department of National Reference Laboratory, Kathmandu,
692 patients retrieved from the histopathology
15189:2022, was prepared byfromTechnical Committee ISO/TC it can be appliedoftoNational
department users, Reference
vendors, Laboratory,
regulatory Kathmandu,
authorities,
from May 2016
May 2016 to April
to April 2019.
2019.
212, Committee for Clinical laboratory testing andhistologic accreditation bodies, other healthcare
in vitro diagnoses comprised of benign, precursor, and malignant lesions services, such as
Results: A total
Results: A total of 701
of the
701European diagnostic imaging, respiratory therapy,
histologic diagnoses comprised of benign, precursor, and malignant lesions and physiological and
diagnostic test systems, in collaboration
accounted for forwith
86.6%, 2.6%, and and 10.8%
10.8%sciences,
respectively with preponderance
preponderance in females.
females. The
The common benign
accounted
Committee for Standardizationlesions
(CEN) 86.6%,
Technical 2.6%,
Committee respectively blood
with banks, and transfusion
in services.
common The use
benign
included melanocytic nevus (17.7%),
(17.7%), epidermal
epidermal cyst
cyst (11%),
(11%), hemangioma
hemangioma (8.9%),
(8.9%), dermoid
dermoid cystcyst
lesions included
CEN/TC 140, Committee for(8.2%), In vitro
melanocytic
diagnostic medical
nevus of this document facilitates cooperation between medical
(8.2%), chalazion
chalazion (6.7%),
(6.7%), and squamous
and squamous papilloma
papilloma (6.4%).
(6.4%). Tumour
Tumour of of epidermal
epidermal origin
origin was
was the
the most
most
devices, in accordance withcommon
the agreement
common neoplasticon
neoplastic lesion accountinglaboratories
technical
lesion accounting for 31.2%.
for 31.2%. Basaland cell
Basal othercarcinoma
cell
healthcare
carcinoma (50%)
(50%)
services,
followedassists
followed
in the
by sebaceous
by sebaceous
carcinoma (27.6%)Agreement).
and squamous
squamous 3 cellexchange
carcinomaof information,
(14.5%) andthe
constituted themajority
harmonization of methods
of malignant
malignant lesions
cooperation between ISO and CEN (Vienna
carcinoma (27.6%) and cell carcinoma (14.5%) constituted the majority of lesions
As the parent documents, ISO prevalent
9001 and above ISO the age of 60 years and
with theprocedures.
preferential On
site top
of theof that
upper patient
eyelid forexamination
basal cell results
carcinoma
prevalent above the 17025,
age of 60have years with the preferential site of the upper eyelid for basal cell carcinoma
and squamous
been updated, ISO 15189 required
and squamous
revisionscellcell carcinoma;
to align with the
carcinoma; and lower
and
get comparable
lower eyelid
eyelid for between
for sebaceous medical
sebaceous carcinoma.
carcinoma. laboratories, regardless of
format of these parent standards. 4
Annex BBenign
Conclusions: in the document
Benign eyelid lesions city
lesions are or
are more country,
more prevalent when
prevalent than medical
than malignant laboratories
malignant ones ones with conform
with overall to
overall female this
female
Conclusions: eyelid document. 3
preponderance.
compares ISO 9001:2015 and ISO 17025:2017 with ISO Epidermal tumours are common among neoplasms. A malignant tumour, a disease
preponderance. Epidermal tumours are common among neoplasms. A malignant tumour, a disease of of
15189:2022. an elderly
an elderly individual,
individual, is
is predominated
predominated by
by basal
basal cell
cell carcinoma
carcinoma followed
followed by
by sebaceous
sebaceous carcinoma,
carcinoma, an
an
aggressive tumour with a high recurrence rate
CHANGES in our population.
IN NEW
aggressive tumour with a high recurrence rate in our population.
This standard promotes the welfare of patients and the
satisfaction of laboratory users through confidence in the The new standard is focused on risk management (aligned
quality and competence of medical laboratories and it with ISO 22367:2020), the impact of services on patients, and
opportunities for improvement within medical laboratories.5
The layout of the standard has been modified as it has been
INTRODUCTION
Correspondence: INTRODUCTION
aligned with its parent standards: ISO 17025:2017 and ISO
Correspondence:
Dr. Reshmi
Dr. Reshmi Shrestha,
Santosh Shrestha,
Pradhan,MD MD
MD 9001:2015.
Eyelid lesions Theareterms
quiteand definitions
common haveofbeen
and most
most reviewed
the surgically
surgically
Associate
Departmentprofessor, Department
of Clinical of Pathology
Biochemistry,Pathology Eyelid
with lesions
some are quite
inclusions, common
exclusions,and of the
updates, and a new
Associate professor, Department of excised ophthalmic
ophthalmic specimens
specimens submitted
submitted for for histopathologic
histopathologic
excised
ordering of entries. (Table. 1) “Quality manual”
Numerousinand
as the
Nepalese
Samyak Army Institute
Diagnostic Pvt. of Health Sciences
Ltd.,Lalitpur, Nepal.
Nepalese Army Institute of Health Sciences evaluation are are obtained
obtained from from thisthis site.
site. Numerous and
ORCID ID: 0000-0002-9914-9213
0000-0002-1249-850X evaluation
previous edition, is not a specific requirement. However,
ORCID ID: 0000-0002-9914-9213 diverse pathologic
pathologic lesions
lesions inin the
the eyelids
eyelids are
are due
due toto their
their
Email: drsantosh.samyak@gmail.com
reshmishrestha2070@gmail.com diverse
information relatingfeatures
to the structure and function of the
Email: reshmishrestha2070@gmail.com unique anatomical as the whole skin structures
Received : 23rdrd December 2020 ; Accepted : March 7thth 2020 unique
laboratoryanatomical features as system
and its management the whole
must skin structures
be available for
Received :: 23
January 3, 2023;
December Accepted
2020 : March
; Accepted 10, 2023
: March 7 2020 with
with its appendages,
its appendages, skeletal muscle,
skeletal muscle, modified
modified glands,
glands,
both the laboratory
and conjunctival
conjunctival mucous personnel
mucous membrane and the
membrane are users to access.
are represented
represented inThe
in
Citation: Shrestha R, Gautam
Pradhan S, Sayami G.
K, Study
Pant V.ofISO
histomorphological spectrum
15189:2022; what’s new inofnew?
eyelid lesions.Nep.
J Pathol J Pathol
2023;
Citation: Shrestha R, Sayami G. Study of histomorphological spectrum of eyelid lesions. J Pathol
13(1):2027-8. DOI: 10.3126/jpn.v13i1.54455
and
termeyelid.
“quality1,2 manager” is not included in the new edition
Nep. 2021;11:1790-1803 DOI: 10.3126/jpn.v11i1.31244 the
the eyelid. 1,2 Eyelid lesions can be divided into congenital,
Eyelid
but lesions
there iscan be divided into congenital,
Nep. 2021;11:1790-1803 DOI: 10.3126/jpn.v11i1.31244
Copyright:
of the standard
inflammatory, nonneoplastic a requirement
masses, for laboratories
and neoplasms
neoplasms (benign
Copyright: This is is an
an open-access
open-access article
article distributed
distributed under
underthe
theterms
termsofofthe
theCreative
CreativeCommons
Copyright: This
Attribution 4.0 is an open-access article
International
International License,
License, which
distributed
whichpermits
under the terms
permitsunrestricted
unrestricteduse,
of the Creative
use,distribution,
distribution,and
Commons
Commons
andreproduction
inflammatory,
to malignant).
have personnel nonneoplastic masses,
responsible and
for the (benign
implementation,
reproduction
or
or malignant). Neoplastic lesions can be further classified
andNeoplastic lesions canmanagement
be further classified
Attribution
in any 4.0 International
medium, provided the License, author
original which permits
and unrestricted
source are use, distribution, and reproduction
credited.
in any medium, provided the original author and source are credited.
in any medium, provided the original author and source are credited. monitoring, improvement of the system.6
DOI : 10.3126/jpn.v13i1.54455 DOI :: 10.3126/jpn.v11i1.31244
DOI 10.3126/jpn.v11i1.31244
2028 Pradhan S et al.

Table1: Terms and definitions included and excluded in ISO 15189: 2022
Included Excluded
Bias/Measurement Bias Accreditation
Clinical Decision Limit Automated selection
Commutability of Reference Material/Commutability Competence
Complaint Critical interval

Consultant Documented procedure

Examination Procedure Laboratory director
External Quality Assessment Laboratory management
Impartiality Process
Internal Quality Control Quality
In Vitro Diagnostic Medical Device (IVD) Quality objectives
Laboratory User Quality policy
Management System
Measurement Accuracy/Accuracy of Measurement/Accuracy
Measurement Uncertainty (MU)
Patient
Trueness/Measurement trueness

Besides these, there are some major changes in this new
standard. One of the major changes is that this version is
less prescriptive than previous ones, which means the
medical laboratory has the flexibility to meet and justify the
requirements set out in the document. Another significant
change from ISO 15189:2012 is that point of care testing
(POCT) is now included in the new standard, so ISO
22870:2016 is withdrawn. There is an Annex in the standard
to summarize the requirements for POCT.5
The main changes to sum up: 3
Š Alignment with ISO/IEC 17025:2017 resulted in the
management requirements now appearing at the end of
the document;
Š Requirements for point-of-care testing (POCT),
previously in ISO 22870, have been incorporated;
Š Increased emphasis on risk management.
WHAT NEXT
To implement this standard, the medical laboratories should
perform a gap analysis between the requirements of ISO
15189:2022 and the quality management system already
in place. Since the POCT standard is integrated into the
new ISO 15189, those organizationsOaccredited to ISO
15189:2012, and those also accredited to ISO 22870:2016,
will need transitional assessments and be accredited to the
updated version of ISO 15189. The International Laboratory
Accreditation Cooperation (ILAC) has set an implementation
period of 3 years from the date of publication of this revised
standard for accredited organizations to adopt the new
standard. As most of the requirements in existing documents
remain unchanged, laboratories which already have effective
quality management systems should be able to adapt to the
new requirements without any trouble.5,6
REFERENCES
1. Plebani M, Sciacovelli L, Chiozza M, Panteghini M. Once upon a
time: a tale of ISO 15189 accreditation. Clinical Chemistry and
Laboratory Medicine (CCLM). 2015; 53(8): 1127-9. Crossref
2. Schneider F, Maurer C, Friedberg RC. International Organization for
Standardization (ISO) 15189. Ann Lab Med. 2017; 37(5):365-70.
Crossref
3. International Organization of Standardization. Medical laboratories—
requirements for quality and competence. ISO Guide 15189. Geneva
(Switzerland); ISO: 2022
4. International Accreditation Service [Internet]. ISO 15189:2022
Medical Laboratories – Requirements for quality and competence has
been published; 2023 January 11. [Cited 2023 February 6]; Available
from: Website
5. The Royal College of Pathologists [Internet].London: A New
Standard: The Introduction of ISO 15189:2022; 2022 December 6.
[Cited 2023 February 6]; Available from: Website
6. Ricketts D. BSI [Internet]. BS EN ISO 15189:2022 – A BSI executive
briefing; [Cited 2023 February 8]; Available from: Website

DOI : 10.3126/jpn.v13i1.54455