KAN-TN-LM 03 - KAN Requirement for Accreditation of Medical Laboratory in the Field of Immunology

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KAN-TN-LM 03

Komite Akreditasi Nasional

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KAN TECHNICAL NOTES ON
MEDICAL LABORATORY IN
THE FIELD OF IMMUNOLOGY

Issue Number: 3

April 2016

Komite Akreditasi Nasional
National Accreditation Body of Indonesia
Gedung I BPPT LT.1 4
JI. M.H. Thamrin No. 8, Kebon Sirih, Jakarta 10340 - Indonesia
Tel.
: 62 21 3927422
Fax.
: 62 21 3927528
Email
Website

: laboratorium@bsn.go.id ; labmedik kan@yahoo.com
: www.kan.or.id

VKAN
Issue Number: 3

KAN-TN-LM 03

7 April 2016

APPROVAL SHEET

ｾ

Reviewed by

Ｌ＠

{

Quality Manager of National Accreditation Committee
of Indonesia (KAN)

Approved by :

ｾ＠

Director of National Accreditation Committee
of Indonesia (KAN)

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Issue Number: 3

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LIST OF AMENDMENT

No.

Date

Part number
revised

1

January 2008 Clause 1
Clause 2

2

Clause 3

3

Clause 5

4

Clause 6

Brief description of changes
Omittina Clause 1 (a) and (b)
Omitting "a pharmacist or a veterinarian"
and urine, and tissue aspirates in clause 2
(d)
Omitting clause 2 (f)
Clause 3 was revised as a whole

Part
revision
number
1

Omitting clause 5 (i), (iii), (v), (viii) , (ix),
(xii), (xiii), 5 (k) and 5 (I)
Omitting Clause 6 ©and (g)

5

7 April 2016

Identification
document
KAN-R-LM
03

Identification document changed to KANTN-LM 03

2

6

7 April 2016

Clause 1

2

7
8

7 April 2016
7 April 2016

Bibliography

Replace SNI ISO 15189:2009 into SNI
ISO 15189:2012
Add Clause 7 and 8
Add "College of American Pathologist,
Immunology Checlist, CAP No. 5755901 ,
Section I Deoartment: Immunology"

1
1

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Issue Number: 3

KAN· TN-LM 03

KAN TECHNICAL NOTES ON MEDICAL LABORATORY
IN THE FIELD OF IMMUNOLOGY

1

INTRODUCTION

a

This technical notes are an interpretation of the general requirements of SNI ISO
15189:2012

b

These accreditation technical notes are applicable to medical testing in the field of
examinations of immunology, technical testing, type of test, and or specific
examination in immunology area, as extra information to the already generally
stated requirements in each of the clauses SNI ISO 15189:2012.

c

Immunology is a broad branch of biomedical science that covers the study of all
aspects of the immune system in all organisms. It deals with, among other things,
the physiological functioning of the immune system in states of both health and
disease;

malfunctions of the immune system in

immunological disorders

(autoimmune diseases, hypersensitivities, immune deficiency, allograft rejection) ;
the physical, chemical and physiological characteristics of the components of the
immune system in vitro, in situ, and in vivo.

d

Immunology

examination

is

taken

to

be

include

examinations

of

immunochemistry, molecular pathology, autoantibody detection and immune cell
function such as acetylcholine receptor antibody,
adrenal

antibody,

adrenal

antibody

serum

adenovirus antibody titer,
test,

alpha

1-antitrypsin,

anticardiolipin antibody, antideoxyribonuclease-B titer, serum anti-DNA, antibody
test,

antihyaluronidase titer, antimitochondrial antibody, antineutrophil antibody,

antineutrophil cytoplasmic antibody,

a ntinuclear antibody, antistreptolysin 0

titer serum, automated reagin test, b eta 2-microglobulin , Bordetella pertussis,
measles antibody test, mixed lymphocyte culture, mumps serology, m ycoplasma
serology,

Leishmaniasis

Lymphogranuloma

serological test, Leptospirosis serodiagonsis test,

venerum

titer,

Entamoeba

histolytica

serological

test,

Helicobacter pylori serology test, hepatitis A antibody test (anti-HAV antibody),
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hepatitis B antigen (HBsAg), hepatitis B core antigen (HBc Ag), anti-hepatitis B
core antigen (anti-HBc Ag), hepatitis B-e antigen (HB-e Ag), anti HB-e Ag, anti
HIV-1/ HIV-2 antibody, C3 complement, C4 complement, Candida antigen test,
cerebrospinal fluid immunoglobulin G, cerebrospinal fluid myelin basic protein ,
complement total, Coxsackie A virus titer, cryoglobulin serum, cytomegalovirus
antibody test, TORCH, etc.

2

PERSONNEL

a

The laboratory analyst has been working in immunology examination areas of a
medical laboratory for at least two years.

b

Technical manager, laboratory supervisors and laboratory analyses shall
possess a basic education in medical technologist, biological analysis, health
analysis vocation or a related science.

c

Consultations and clinical interpretations of examination test results shall be

provided by a qualified immunologist.
d

Qualified immunologist is a physician, a biologist or a veterinarian responsible
for the interpretation data derived from body fluids such as blood , urine, and
tissue aspirates.

e The laboratory shall be directed by persons having executive responsibility and
competence to

assume

responsibility for the

services

of

immunology

examination
f

Laboratory management shall ensure that:
Appropriate numbers of laboratory personnels, with the required education
and training , to meet the demands of the service to customers.
ii

Laboratory personnels have knowledge, skills, and abilities based on
education, experience, demonstrated skills, and training to perform their
duties.

iii

Full educational and professional records of all technical staffs available to
confirm their competence in immunology testing

g

The laboratory management shall involve in the continuous education of all the
staff.
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h

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Laboratory shall establish and define an internal training program and ensure the
competency of laboratory personnel.
Performance of laboratory personnel shall be evaluated regularly to ensure their
continuing competence.
Laboratory shall have training procedure that is used to ensure that training has
taken place with each employee for procedures and methods that the employee
performs. The procedure applies to on-the-job training , in-house training and
new-hire training.

k

The training procedure is applicable to new employees, for the introduction of
new procedures and methods, for re-training of employees, and for reverification of employee performance.
The laboratory shall maintain an up-to-date record of the training that each
member of staff has received.

3

EXAMINATION METHODS

a

The examination method is adequately documented based on the latest valid
edition of a published reference method, including:
title and method number
ii

scope and field of application ,

iii

number of revision

iv

page numbering, total number of pages

v

references ,

vi

principles and definitions,

vii

reagents and materials,

viii

apparatus,

ix

analytical methodology,

x

expression of results,

xi

performance criteria ,

xii

quality control,

xiii

reporting criteria,

xiv

issuing authority.
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b

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Laboratory shall have:
written procedures for the proper collection and specimen handling and
storage conditions,
ii

procedures to verify sample identity and integrity,

iii

policy and specification for the maximum interval during which a
specimen may be used for the specified examination ,

iv

clinical information and diagnosis provided on the request form,

v

procedures to verify sample identity and integrity,

vi

documentations detailing methods for patient identification, specimen
labelling, specimen preservation and storage before testing

vii

written criteria, procedures and records for specimen rejection ,

viii

secondary samples that traceable to the primary sample.

c Supporting work instructions shall be available to:
workinstructions for sample disposal,
ii

work instructions for disinfection/sterilization and disposal of biohazardous
material,

iii

equipment operational instructions I manuals,

iv

work instructions for computer software related data entry; data
approval, data confidentiality, and data safety.

4

EQUIPMENT AND MEASUREMENT TRACEABILITY

a

Laboratory shall have:

list of the major equipment such as spectrophotometer, immunology cell
counter (immuno-phenotyping) , stainer, fluorescence

microscope,

ELISA

instruments ,

I

ECLIA

electrophoresis,

instruments,

micro-ELISA

automated system for including identification , date

received, manufacturer, maintenance service,

ii

procedure specifies the schedule and requirements for maintenance,
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performance, calibration, and verification of laboratory testing equipment
that meets the criteria of the maintenance and calibration parameters
needed to achieve the accuracy of instruments used for analytical testing,
iii

equipment records containing description of the instrument, critical
accessories and software, manufacturer's name, type identification and
serial number; laboratory number; installation qualification (IQ) and
operational qualification (OQ) records obtained from the installer or
manufacturer; and other related material such as instrument service and
repair,

warranty

information,

service

contract

conditions

and

specifications,
iv

laboratory shall have operating instructions for each instrument, including
starting and shutting down the instrument, and troubleshooting,

v

safety

cabinet

shall

have

documented

protocol

and

record

of

decontamination ,
vi

verification at regular intervals of the minimum/maximum time for lysing
from Cell Counting (CD4 & immunophenotyping),

vii

background counts preformed on the diluents and lysing agent to check
for contamination,

viii

automatic pipettes is there an initial verification of volume delivered
checked ,

ix

all instruments shall be verified regularly,

x

there regular checks to ensure that the equipment is performing within
the specifications,

xi

equipment that is not operating properly is clearly marked to show that it
is out of service,

xii

when an instrument is discovered to be improperly operating, it is tagged
and taken out of service.
performance

checks

and

Equipment is not returned to service until
verification

have

been

performed

and

documented,
xiii

each instrument has an established schedule specifying performance
checks, including the testing frequency and acceptable performance
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specifications.

These

performance checks

7 April 2016

are

ensured that

the

instrument is operating properly and consistently prior to analysis,
xiv

all instruments required for the routine examination in immunology field
are available:
a)

regularly scheduled maintenance program for each piece of
equipment, where appropriate and records of service where service
was required ,

b)

distilled water that is producing in-house and or purchasing from
external supplier and used to make media or reagents in
immunology examinations shall check the conductivity periodically.

b

Laboratory shall have arrangement for avoidance

of cross-contamination

arising from equipment, such as :
disposable equipment should be clean and sterile before used when
appropriate, and can not be re-used,
ii

re-used glassware should be properly cleaned and sterilized when
appropriate.

c

Where centrifuges are used in examination procedures , an assessment should
be made of the criticality of the centrifugal force. Where it is critical, the
centrifuge will require calibration. Calibration shall be programmed and evaluated.

5

REAGENTS AND REFERENCE CULTURES
a

Laboratory shall have sufficient & appropriate quantities of reagents /media I
commercial kits available to carry out the volume of work following the required
examination methods.

b

Raw materials (dehydrated formulations and individual constituents) should be
stored under appropriate conditions, e.g . cool , dry and dark.

c

All containers, should be sealed tightly.

d

Stored reagents, reference materials and supplies shall be under the appropriate
conditions and in a

secure manner to ensure the separation of incompatible

materials.
e

Solutions of reagent, standard and any other such as mobile phase properly
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labeled with solution name, concentration, date of preparation, expiration date,
and identity of person who prepared.
f

Disposed of reagents and standards solutions appropriately followed to national
and or local regulation

g

Distilled or de-ionized water systems are monitored for conductivity, bacterial
content, and total chlorine periodically. Heavy metals analysis, water quality test
and use test are performed annually on the water systems.

h

Laboratories shall ensure that all reagents including stock solutions, diluents,
and other suspending fluids are adequately labeled to indicate, as appropriate,
identity, concentration, storage conditions, preparation date, and validated expiry
date and I or recommended storage periods.

6

ASSURING THE QUALITY OF EXAMINATION RESULTS

a

Laboratory Quality Control is an essential aspect of ensuring that data
released is fit for the purpose determined by the quality objectives.

b

Approach of quality control is the principal recourse available for ensuring that
only qualified data (patient results) are released; with highly consideration of
grey-zone or hook-effect between patient samples and reagents used.

c

The Principle of the laboratory quality control program are:

internal quality

control to monitor the analytical performance, and external quality control based
on the laboratory's performance in proficiency testing programs.
d

Laboratory Management is responsible for establishing a Laboratory Quality
Control Program and ensures that quality control is performed and reviewed of
quality control data for acceptability.

e

Analysts (laboratory technicians) are responsible for conducting quality control
analyses in accordance with The Laboratory Quality Control Program.

f

Internal quality control

(IQC)

is used to measure accuracy, precision ,

contamination , and matrix effects. The laboratory determines, where feasible , the
accuracy and precision of all analyses performed. IQC for quantitative tests
should run in daily services; for qualitative tests , positive and negative control
should run in the same run with all patient samples (within run) or Run serologic
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tests on patient specimens concurrently with positive control serum of known titer
or controls of graded activity (if applicable), along with a negative control
g

Accuracy and precision control charts for quantitative data/ results; and data
sheet/ records (sensitivity and specificity) for qualitative data/ results; are
to

determine

if

used

the measurement system process is in control and whether

the results generated by the measurement system are acceptable.

Proficiency testing should be done at regular intervals (twice each year). EQA for
the national reference laboratory may be provided by an independent laboratory
(e.g. a university) or by one of WHO's EQA schemes.

Linked confidential and unlinked anonymous HIV testing should refer to the WHO
regulation.

7

QUALITY MANAGEMENT AND QUALITY CONTROL

a

Documented QM/QC Plan: The immunology laboartory has a written quality
management/quality control (QM/QC) program .

b

Specimen Collection

Manual: There is a documented procedure describing

methods for patient identification , patient preparation, specimen collection and
labeling, specimen preservation, and conditions for transportation, and storage
before testing, consistent with good laboratory practice.
c

Instrument Maintenance Evaluation : There is documentation of monthly of the
maintenance and function of all instrument,s including documentation of
corrective action taken when values for instrument fuction, temperature, etc.
Exceed defined tolerance limits.

8

SPECIMENT COLLECTION AND HANDLING

a Specimen Identity/Integrity: Procedures are adequate to verify sample identity
and integrity (includes capillary specimens, aliquots and dilution).
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b Specimen Rejection Criteria: There are documented criteria for the rejection of
unacceptable specimens and the special handling of sub-optimal specimens.

BIBLIOGRAPHY

1. The RCPA Manual The Royal College of Pathologists of Australasia ABN 52 000
173 231, Version 4.0 12 March 2004
2. Immunology for

biomedical

scientists

a

basic introduction, (2nd

Ed.)

Reynolds Lesley-Jane. 04-2003
3. Centers for Disease Control and Prevention and National Institutes of Health
4. (CDC/NIH). 1999. BioSafety in Microbiological and Biomedical Laboratories, 4th
ed. U.S. Government Printing Office, Washington , D.C.
5. Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories
as Guideline to the ISO 15189 and ISO 17025 Documents, Clin Chem Lab Med
2000; 38(10) :1057-1064 © 2000 by Walter de Gruyter
6. WHO 2012. Quality assurance in Bacteriology and Immunology. 3rn edition. SEARO
Regional Publication No. 4 7.
7. American Academy of Family Physicians (AAFP) 2012.
8. WHO UN-AIDS 2009. Guidelines for using HIV testing technologies in surveillance.
9. College of American Pathologist, Immunology Checlist, CAP No. 5755901 ,
Section I Department: Immunology.

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