SKIM AKREDITASI MAKMAL MALAYSIA (SAMM)

LABORATORY ACCREDITATION SCHEME OF MALAYSIA

SC 2.1 - SPECIFIC CRITERIA

FOR ACCREDITATION IN THE FIELD OF
MEDICAL MOLECULAR TESTING
Issue 1, 14 November 2017
(Supplementary to MS ISO 15189)

MS ISO 15189

JABATAN STANDARD MALAYSIA

Department of Standards Malaysia
TABLE OF CONTENTS
Page
1 Introduction 1
2 Scope 1
3 Terms and definitions 1
4 Management requirements 2
4.1 Organisation and management responsibility 2
4.2 Quality management system 3
4.3 Document control 3
4.4 Service agreements 3
4.5 Examination by referral laboratories 3
4.6 External services and supplies 3
4.7 Advisory services 4
4.8 Resolution of complaints 4
4.9 Identification and control of non-conformities 4
4.10 Corrective Action 4
4.11 Preventive Action 4
4.12 Continual improvement 4
4.13 Control of Records 4
4.14 Evaluation and Audits 4
4.15 Management Review 5
5 Technical requirements 6
5.1 Personnel 6
5.2 Accommodation and environmental conditions 10
5.3 Laboratory equipment, reagents, and consumables 11
5.4 Pre-examination processes 11
5.5 Examination processes 12
5.6 Ensuring quality of examination results 12
5.7 Post-examination processes 13
5.8 Reporting of results 13
5.9 Release of results 14
5.10 Laboratory information management 14
Appendix 1 Classes/ sub-classes of test/ test platform 15
Appendix 2 Table 1- Recommended calibration and performance check of equipment 16
commonly used in the medical molecular testing laboratories
References 19
Acknowledgements 21
 SC 2.1: SPECIFIC CRITERIA FOR ACCREDITATION IN THE FIELD OF MEDICAL MOLECULAR TESTING

SPECIFIC CRITERIA FOR ACCREDITATION IN THE FIELD OF MEDICAL MOLECULAR TESTING

1 Introduction

1.1 This document describes the requirements for accreditation of medical molecular testing
laboratories involved in nucleic acid testing in a broad variety of human samples.

1.2 This document should be read in conjunction with the MS ISO 15189 standard.

1.3 Clause numbers correspond to those in the standard which require elaboration.

2 Scope of accreditation

The areas for which accreditation offered are:

2.1 Inherited diseases

2.2 Cancer genetics

2.3 Infectious diseases

2.4 Immunogenetics

2.5 Pharmacogenomics

Please refer to Appendix 1 for classes/ sub-classes of test/ test platform.

3 Terms and definitions

All terms and definition given in MS ISO 15189.

(i) Medical molecular testing laboratory - any services in the molecular analysis of nucleic
acid derived from human tissue or fluid or any other product of the human body.

(ii) Result - data without clinical interpretation and may have a descriptive comment.
Examples of descriptive comments:
a) Medical molecular testing
- point mutation detected
- deletion detected
- xx mutation not detected

b) Quantitative analysis
- 10,000 copies/ml
- 2.4x risk of having colorectal cancer
- normal allele detected with approximately 32 CGG repeats and no expansion in
the FMR1 (NM_002024.4) gene

(iii) Report - interpretative report issued containing clinically relevant inferences from test
results or analytical findings.
Example:
- Fragile X diagnosis is unlikely but not ruled out (approximately 1% possibility of
point mutation or gene deletion)
- Duchenne muscular dystrophy gene mutation with in-frame deletion of the gene

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detected. Parental blood sample is required. Genetic counseling is recommended.

(iv) Authorised requester (Clause 5.4.1 of MS ISO 15189)

A medically-qualified practitioner or his/her authorised designee (e.g. genetic
counselor, qualified staff nurse) or a person acting under a medicolegal directive (e.g.
enforcement officer).

(v) Person authorised to receive laboratory test result and report (Clause 5.8.3 of MS ISO
15189) - The person authorised to receive the laboratory test result or report shall be
the authorised requester or his/her authorised designee.

(vi) Subject Matter Experts (SME) is a person with knowledge and expertise in a specific
subject or technical area.

4 Management requirements

4.1 Organisation and management responsibility

4.1.1.4 Laboratory director (person-in-charge)

The laboratory director shall be the person-in-charge of the services of the laboratory and
should be resident to the laboratory. There may be more than one laboratory director if the
scope of services provided by the laboratory extends over more than one specialty of
pathology such that a single laboratory director may not have the competence to assume
responsibility for all the services provided. Where national regulations apply, statutory
requirements with regard to competence, qualifications and experience of the laboratory
director (person-in-charge) shall be complied with.

Note: ‘Resident’ connotes that the laboratory director works in-house and the laboratory is
the main place of professional practice.

The laboratory director shall be:

a) Medically qualified pathologist (i.e. a medical practitioner registered with the Malaysian
Medical Council, with a postgraduate qualification in pathology approved by the
Government of Malaysia) and a minimum of three (3) years working experience as a
pathologist; or

b) Registered medical practitioner with relevant molecular testing laboratory experience of at

least seven (7) years; or

c) Scientist with appropriate qualification and laboratory experience in molecular testing

laboratory of at least seven (7) years.

The laboratory director and his designees are regarded as key personnel. Key personnel
shall normally include:

(a) Quality manager;

(b) Technical manager;

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(c) Document controller;

(d) Subject Matter Expert.

4.1.1.4c) Sufficiency of staff to meet needs

The appropriateness of Subject Matter Experts (SMEs) (technical or clinical personnel)

engaged shall be interpreted using the following guidelines:

(a) Where there is insufficient or no resident SME to provide the clinical input or advisory
services required in Clause 4.7, the services of a visiting SME with relevant experience
should be engaged.

(b) The laboratory shall engage the services of technical personnel trained in medical
molecular testing under the scope of accreditation. Where resident technical personnel
are unable to cover all the services offered, suitably qualified and experienced part-
time technical personnel shall be engaged.

(c) There shall be at least one (1) technical personnel present in the laboratory, during all
working hours.

4.2 Quality management system

As in MS ISO 15189

4.3 Document control

As in MS ISO 15189

4.4 Service agreements

4.4.1 Where a laboratory is a part of a hospital and provides in-house services to the hospital,
the internal arrangement between the hospital management and the laboratory
management may be considered as an agreement and the requirements of this clause
apply. The agreement may be in the form of a request form, memorandum, manual,
circular, letter, minutes of a meeting, etc. which shall be controlled.

4.5 Examination by referral laboratories

4.5.1 In exceptional circumstances where an examination is sought on an esoteric or unusual

condition, and the request is urgent, one-off or ad-hoc in nature, the examination may be
referred to a laboratory or a second opinion sought from an individual, without prior
management evaluation. The reasons for such a referral shall be documented by the
appropriate laboratory director or key personnel, to show why this referral is in the best
interest of patient care.

This clause does not apply where a sample is to be examined by another laboratory, as
arranged by a requester and the pathology laboratory merely acts as a handling centre on
behalf of the requester. The examination results of such samples shall not be issued under the
name of the pathology laboratory and the laboratory shall not make any statement on its
accreditation status regarding the examination results.

4.6 External services and supplies

As in MS ISO 15189

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4.7 Advisory services

SMEs should be available to provide relevant advice prior to test ordering and to advise on
the interpretation of test results. A laboratory handbook provides guidance to authorised
requester on the choice and cost of tests.

4.8 Resolution of complaints

As in MS ISO 15189

4.9 Identification and control of non-conformities

As in MS ISO 15189

4.10 Corrective Action

As in MS ISO 15189

4.11 Preventive Action

As in MS ISO 15189

4.12 Continual improvement

The important aspects to monitor and review are:

(a) test repertoire, including standard testing profiles, reflex testing, procedures for follow
up and confirmatory testing;

(b) methodology which involve amplification and technical precision instrumentation

considerations, including specificity, sensitivity and uncertainty of results, in relation to
clinical decision making;

(c) recent update and advances in relation to the identification of previous variants of
unknown clinical significance emerging as being disease associated.

4.13 Control of records

4.13.1 A copy of examination results and reports issued shall be kept in the record system or it
shall allow one to be reproduced upon request.

4.13.2 Minimum retention periods for patient records and specimens shall conform to relevant
national guidelines / regulations where available such as College of Pathologists, Academy
of Medicine Malaysia Guideline on Retention of Pathology Records and Materials.

4.14 Evaluation and audits

4.14.1 - 4.14.4
As in MS ISO 15189

4.14.5 Internal audit

Auditors shall have adequate knowledge in MS ISO 15189 and receive relevant training to
conduct internal audit.

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The elements to be audited may include but not limited to the following:

(a) staff awareness of the quality manual;

(b) analytical procedure selection, control and validation;

(c) control of reagents and standards;

(d) equipment calibration and maintenance records;

(e) proficiency testing and inter-laboratory comparison;

(f) audit trails in quality and technical records;

(g) personnel training records;

(h) handling of deficiencies and remedial action; and

(i) laboratory housekeeping and health and safety measures.

4.14.6 Risk management

The laboratory shall identify and document potential failures in its quality management
system including the pre-examination, examination and post examination work processes
which affect examination results using methods such as Failure Mode and Effect Analysis
(FMEA) or similar risk assessment tools. Periodic evaluation of one or more of the following
indicators may be conducted:

(a) Specimen;

(b) Test system (Equipment and methodology);

(c) Reagents;

(d) Environment;

(e) Personnel.

Reference may be made to the following documents:

(a) MS ISO 31000 – Risk Management – Principles and Guidelines on Implementation;

(b) MS IEC/ISO 31010 – Risk Management – Risk Assessment Techniques;

(c) MS ISO Guide 73 – Risk Management – Vocabulary;

(d) MS 2370 – Medical Laboratories – Reduction of Error through Risk Management and
Continual Improvement.

4.15 Management review

As in MS ISO 15189

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5 Technical requirements

5.1 Personnel

5.1.1 General

The laboratory shall have documented procedures and maintain records that includes
recruitment, appointment and assignment of all managerial, clinical, scientific and technical
personnel and their performance appraisals based on predetermined individual targets. The
recruitment and qualifications of laboratory personnel shall be in compliance with relevant
existing laws in the country.

5.1.2 Personnel qualifications

The competency of personnel is a major aspect of each laboratory assessment as the standard of
performance depends heavily on the competence of the laboratory’s personnel.

Four (4) categories of personnel will be assessed. They are:

(a) Technical personnel;

(b) Scientific personnel;

(c) Clinical personnel; and

(d) Management personnel.

a) Technical personnel

A technical personnel refers to staff who perform molecular technical work. They shall have
suitable qualifications and training with sufficient experience and ability to perform the
required task. This shall be evidenced by:

i) a Diploma in Medical Laboratory Technology or an equivalent, recognised by the

Government of Malaysia and at least one (1) year of supervised training in the
relevant area of the laboratory service (as post-diploma training); and

b) Scientific personnel

A scientific personnel refers to staff who perform and evaluate advanced and high-end
technical work. They shall have suitable qualifications and training with sufficient experience
and ability to perform the required task. This shall be evidenced by:

a) Doctorate of Philosophy in a subject relevant to the field of molecular biology /

molecular genetics / human genetics recognised by the Government of Malaysia with
at least one (1) year experience in molecular diagnostics; or

b) Masters of Science Degree in a subject relevant to the field of molecular biology /

molecular genetics / human genetics recognised by the Government of Malaysia with
at least three (3) years’ experience in molecular diagnostics; or

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c) Bachelor of Science Degree or equivalent qualification in a subject relevant to the

field of molecular biology / molecular genetics/human genetics recognised by the
Government of Malaysia with at least five (5) years’ experience in molecular
diagnostics.

Records of evaluation of competence in the tasks assigned to the person.

The laboratory shall ensure that technical and scientific personnel assigned to perform new or
rarely used techniques undergo appropriate training. Records of training and assessments of
competence shall be kept. These shall include records of results of examinations/tests
performed during training and competence assessments. The validity of results produced by
technical personnel, particularly in the first six months after completion of training in new techniques
shall be monitored.

Personnel who are physically challenged may affect the performance of certain types of
laboratory tests. It is the responsibility of the laboratory management to assign duties and
take appropriate steps to ensure that validity of results and laboratory safety are not
compromised.

c) Clinical personnel

Clinical interpretation of test results shall be provided by a medically qualified person who
has obtained post graduate qualification in appropriate specialty plus two (2) years post
graduate laboratory experience in molecular genetics.

A service medical officer can also provide clinical interpretation provided they are under the
direct supervision of a medically qualified person as mentioned above.

Visiting pathologists

A visiting pathologist is a medically-qualified pathologist who periodically visits a laboratory

and provides services in areas where the laboratory director, or other personnel of the laboratory,
cannot adequately discharge the responsibilities that are appropriate to the services provided by the
laboratory. These services may be supervisory or the provision of clinical interpretation of
examination/test results or the performance of examinations or other services.

The visiting pathologist shall be qualified in the specialty where he/she is providing services
and shall comply with the competence requirements of clinical personnel.

A formal and written arrangement between the laboratory and the visiting pathologist shall be
established. The arrangement shall ensure that:

(i) an effective working relationship between the laboratory director and visiting
pathologist is established;

(ii) advices and recommendations of the visiting pathologist are acted upon within the
required timeframe;

(iii) the frequency and duration of visits are defined and appropriate to the volume and
scope of work undertaken by the visiting pathologist. This may take into account
the availability of electronic links, which enable remote supervision of laboratory
output;

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(iv) the functions, roles and activities of the visiting pathologist as well as his/her
authorities and responsibilities are clearly defined;

(v) records of input by the visiting pathologist are kept, the means by which the
visiting pathologist can be contacted in cases when his/her advice is required urgently
is established;

(vi) an effective system to allow the provision of clinical advice as well as signing of
examination reports by the visiting pathologist within a timescale appropriate to the clinical
situation is in place; and

(vii) liabilities of the examination results and their interpretations are clearly defined.

d) Management Personnel

The quality management team shall include the relevant key personnel and at least a medically
qualified personnel as mentioned in para (clinical personnel) who may be a visiting pathologist.

The technical manager of the laboratory (or section) may be a medically qualified
personnel, a scientist in the relevant areas, or medical laboratory technologist with
specialised training and/or appropriate experience in molecular genetics.

The suitability of personnel in performing their management shall be assessed. Aspects that
will be considered include:

(a) the qualifications and professional experience of persons with management;

(b) the workload of the laboratory and the range of tests offered;

(c) the contact that managers maintain with subordinate staff; and

(d) the involvement of managers in the development of methodology and adoption of new
methodology within the laboratory.

Persons with supervisory roles shall have sufficient authority, skills and experience to train and
supervise subordinate personnel.

Contracted personnel

When a laboratory uses contracted personnel irrespective of the duration of the contract and whether
the contracted personnel member is employed on a full-time or part-time basis, the laboratory shall
ensure that the requirements for staff competence are met. Evaluation of the competence of these staff
shall be carried out and records kept. Where necessary, training shall be provided, particularly with
regard to those parts of the laboratory quality management system that are relevant to their assigned
duties. Direct supervision may be required initially to ensure that the contracted personnel are competent in
carrying out their duties.

5.1.3 Job descriptions

Responsibilities of key personnel

(i) Key personnel would be expected to have:

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 A position in the staff organisational chart which provides for the authority to
implement necessary changes in the laboratory operation to ensure the integrity of
test results is maintained.

 A working knowledge of the quality assurance system and operation of the

laboratory on a day-to-day basis.

 A working knowledge of and commitment to the requirements for SAMM

accreditation, including the quality and technical management principles embodied
in MS ISO 15189 and relevant SAMM criteria/requirement.

 The necessary expertise and experience to be aware of, and understand, any
limitation of the test procedures, and to understand fully the scientific basis of the
procedures.

(ii) Key personnel can be given both the responsibility and authority to:

 Develop and implement new operational procedures.

 Design quality control programmes, set action criteria and take corrective action
when these criteria are exceeded.

 Identify and resolve problems.

 Take responsibility for the validity of the outputs.

(iii) Clinical, scientific and technical personnel who are not engaged full-time could also be
appointed as key personnel. However, the circumstances in which they are called upon
to exercise their key personnel responsibilities and their access to and knowledge of
the laboratory’s operations, should be such that they are able to take full responsibility
for the work they undertake, authorise or oversee.

5.1.6 Competence assessment

The competency of all clinical, scientific and technical personnel to perform assigned tasks
shall be reassessed, at least once in two years. Personnel who undertake duties after a
significant period of absence as specified in the laboratory policy are expected to undergo
reassessment and retraining if necessary. Records of training and competency attainment
shall be endorsed by both trainer and trainee.

5.1.8 Continuing education and professional development

Continuing education and continuing professional development are important for

maintaining competence of clinical, scientific and technical personnel. These include in-
house and external activities and use of appropriate reference texts and journals.
Examples are:

External

 Attendance at professional conferences, seminars and lectures.

 Educational attachments or visits to other laboratories.
 Participation in training courses and workshops.

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Internal

 Regular educational presentations

 Journal article reviews
 Case presentations
 Participation in research activities
 Review of QAP educational material
 Review of interesting/abnormal cases

As a guideline for a minimum level of participation, all clinical personnel would be expected
to spend at least 42 hours in a year and all technical personnel would be expected to
spend at least 20 hours in a year participating in these activities, unless otherwise directed
by the accreditation body following a peer-review assessment.

5.2 Accommodation and environmental conditions

5.2.6 Facility maintenance and environmental conditions

Laboratories performing medical molecular testing shall be obliged to demonstrate

appropriate measures in order to minimize contamination as well as risk to personnel. The
laboratory should have dedicated areas for handling samples, pre and post analysis to
minimize cross-contamination.

The testing laboratory should be flexible in meeting increased sample volumes, process
changes and new technologies.

The laboratory shall comply with the relevant statutory procedures for accommodation,
environmental conditions, radioactive handling and waste disposal. The laboratory should
be designed to ensure a comfortable and safe working environment. Reference may be
made to the following documents:

 Establishing Molecular Testing in Clinical Laboratory Environments, Approved

Guideline (CLSI);

 American College of Medical Genetics – Standards and Guidelines for Clinical

Genetics Laboratories 2008 Edition;

 WHO Laboratory Biosafety Manual;

 College of Pathologists, Academy of Medicine Malaysia guidelines;

 Occupational Safety and Health (Use and Standard of Exposure Chemical Hazardous
to Health) Regulations 2000 (USECHH Regulations);

 Guidelines on Chemical Management in Health Care Facilities Ministry of Health 2010.

Safety

While safe laboratory practice forms an important part of providing a quality service and will be
necessary to achieve the standards required for accreditation, an assessment does not constitute a
formal safety audit.

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National authorities are responsible for occupational health and safety in laboratories. However, it is
an expectation of the standard that all applicable standards and guidelines relating to medical
laboratories in Malaysia, and recognised best practice, shall be implemented. Attention shall be
drawn to any unsafe practices that are encountered. Where instruction and advice related to safety
are written into test methods covered by accreditation, these shall also be observed.

A safety manual detailing the laboratory’s policies and procedures in relation to health and safety
shall be readily available to staff.

Due consideration shall be given to separating certain procedures from the main work area for the
safety of workers, the protection of the environment and to maintaining the validity of the result. Such
procedures include but are not limited to:

(a) those that may pose a hazard to other staff (e.g. tests using potentially carcinogenic
reagents, contagious specimen, volatile substances, radioactive materials); and

(b) those procedures which may be affected or influenced by not being segregated (e.g. tissue
culture, PCR work).

5.3 Laboratory equipment, reagents, and consumables

As in MS ISO 15189

5.3.1.4 Equipment calibration and metrological traceability

Reference should be made to SAMM Policy 2. Test or calibration equipment that has a
significant effect on the reported results and associated uncertainties of measurement
(including, where relevant, instruments used for monitoring environmental conditions) shall
be calibrated by (one or more) of the following:

(a) Standards Malaysia accredited calibration laboratories.

(b) Calibration laboratories accredited by one of Standards Malaysia’s Mutual Recognition

Agreement (MRA) partners.

Note: An endorsement relating only to ISO 9001 certification is not acceptable.

Standards Malaysia may expect reduced, or accept extended, calibration intervals based
on such factors as history of stability and accuracy and precision requirements. It is the
responsibility of the laboratory to provide clear evidence that its calibration and
maintenance system ensures confidence that the equipment is maintained. Recommended
calibration and/or performance check interval are available in Appendix 2: Table 1.
Reference may also be made to ILAC G 24- Guidelines for the Determination of Calibration
Intervals of Measuring Instruments.

5.4 Pre-examination processes

The selection and collection of sample materials are important elements in medical
molecular testing methods. The general requirement for sampling shall closely follow the
MS ISO 15189 document.

5.4.3 All specimens accepted by the laboratory for testing shall be labeled in accordance with
procedures defined. As a minimum, the specimen label shall carry the following:

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 Two unique identifiers (e.g. name of patient and patient identification number);

 Type of sample (e.g. body fluid, tissue) and anatomic site of origin; and

 Date and time of sampling (if applicable).

5.4.4 Each sample received shall be uniquely identified and matched to the accompanying
request form by at least two unique identifier. Where two or more samples accompany a
request form, these shall be distinguishable from each other in both the labels and request
form.

5.4.6 Sample identification should be traceable constantly at all stages of sample processing
(e.g. specimen receipt, nucleic acid extraction, endonuclease digestion, amplification,
electrophoresis, photography and storage).

5.5 Examination processes

5.5.1 Selection, verification and validation of examination procedures

5.5.1.1 General

Each procedure shall be authorised and dated by the responsible key personnel.

Review of methods shall be documented. Where there are no changes, a date and
signature will be sufficient. Some manufacturers provide method documentation (product
inserts) with their product and these may be included in method manuals. These shall be
authorised as above. Where this information is not sufficiently detailed to cover all required
elements it shall be supplemented by the laboratory. Inserts for new batches received shall
be checked for changes in procedure and a copy of the new insert placed in the manual.

Where a test may be performed by more than one method, there shall be documented
criteria for method selection. Where relevant, the degree of correlation between the
methods shall be established and documented.

5.5.3 Documentation of examination procedure

In additional to Clause 5.5.3 a) - t) of the MS ISO 15189 standard, this information shall be
included:

(a) Type of sample (e.g. body fluid, tissue and blood) and anatomic site of origin, where
applicable; and

(b) Limitation of the examination procedure. Reference may be made to Occupational

Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous
Chemicals) Regulations 2013 (CLASS Regulations).

5.6 Ensuring quality of examination results

5.6.2 Quality control

Positive (including low positive) and/or negative controls shall be run for every batch of
analysis. Its performance shall be reviewed based on acceptance or rejection criteria and
the analytical problems rectified.

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Note: For panels with multiple targets, systematic rotation of controls may be acceptable.

5.6.3 Interlaboratory comparisons

5.6.3.1 The laboratory shall subscribe to at least one external quality assurance programme or
inter-laboratory comparison (national or international) for each test or related group of test
or test method where relevant under the scope of accreditation.

The order of preference for choosing an ILC programme should be:

i) An EQA programme accredited to ISO/IEC 17043;

ii) Recognised EQA programme;

iii) Interlaboratory comparison between accredited labs;

iv) Interlaboratory comparison between non-accredited labs.

Where such ILC programmes are not available, the laboratory shall develop appropriate
quality control activities in compliance to MS ISO 15189 Clause 5.6.3.2.

5.6.3.2 Alternative approaches

The frequency of participation in the interlaboratory comparison (ILC) shall be referred to

SAMM Policy 4.

5.7 Post-examination processes

All samples shall be retained in accordance with national guidelines e.g. College of
Pathologists, Academy of Medicine Malaysia Guidelines.

5.7.2 Storage, retention and disposal of clinical samples

Storage of Nucleic Acids Extract

Nucleic acids should be processed promptly and stored appropriately to minimize

degradation. Samples should be reassessed for integrity before use if stored for prolonged
periods of time at any temperature.

5.8 Reporting of results

5.8.1 General

Approvals for providing interpretations and signing Skim Akreditasi Makmal Malaysia
(SAMM) endorsed reports containing interpretations will be granted to those personnel who
are found to fulfill the relevant requirements. The responsibility for interpretation of the
laboratory’s test results remains with the approved person(s). This responsibility cannot be
delegated to other persons. The person giving the interpretations shall authorise the release of
the report containing his/her interpretation personally.

Department of Standards Malaysia (Standards Malaysia) shall be informed of departure or

changes in the availability of the persons approved for giving interpretations as soon as
possible. Standards Malaysia will take the necessary actions such as amendment of the

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scope of accreditation of the laboratory regarding the availability of consultation and

interpretation services, or suspension of the laboratory’s accreditation, depending on the
circumstances.

5.8.3 Report content

For medical molecular testing report shall follow international guidelines such as:

i) Human Genome Variation Society (HGVS) nomenclature;

ii) EMQN Best Practice;

iii) ACGS General Genetic Laboratory Reporting Recommendations;

iv) Recommendations for Reporting Results of Diagnostic Genetic Testing (Biochemical,

Cytogenetic and Molecular Genetic), M Claustres et al., European Journal of Human
Genetics (2014) 22, 160–170.

5.9 Release of results

Even though, transcription of results are not encouraged, when data are transcribed
manually into an electronic database or otherwise, there shall be a means of checking the
accuracy of transcriptions and entries. Wherever relevant, checking should be performed
by an independent operator.

Electronic transmission of results

It is essential that the integrity of data and confidentiality requirements are met during the
transfer of results by any electronic system.

Where the clinician requests the electronic transmission of results from the laboratory to a
remote location, the responsibility for ensuring the integrity of data transfer to the referring
clinician and other designated addressee, rests with the laboratory.

5.9.3 Revised reports

Additional information may be added as an addendum to the original report, if

necessary/required.

5.10 Laboratory Information System

As in MS ISO 15189.

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Appendix 1

CLASSES/ SUB-CLASSES OF TEST/ TEST PLATFORM

i) Sanger sequencing

ii) Prenatal genetic testing (excludes Non-invasive prenatal screening)

iii) Pre-implantation genetic testing

iv) Genetic testing for constitutional gene variants (diagnostic and carrier testing)

v) Predictive genetic testing

vi) Pharmacogenetic testing

vii) Genetic testing for mosaic gene variants (cancer and somatic mosaicism)

viii) Screening for an unknown mutation

ix) Assay for a defined mutation or polymorphism

x) Assaying heterozygous loci

xi) Calculated estimate of risk of inheritance of an unknown mutation (Bayesian and linkage
calculations)

xii) Massively parallel sequencing

xiii) Non-invasive prenatal screening

xiv) Detection and characterisation of cell free DNA in cancer screening

xv) Infectious disease

xvi) Miscellaneous tests

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Appendix 2

TABLE 1: RECOMMENDED CALIBRATION AND PERFORMANCE CHECK OF EQUIPMENT

COMMONLY USED IN THE MEDICAL MOLECULAR TESTING LABORATORIES

S/N Type of Instrument Maximum Period Between Successive Calibrations or

or Equipment Performance Checks
1. Anaerobic jars and Each use: Check using indicators, vacuum gauge or control cultures.
cabinets
2. Analyzers Check using appropriate controls and standard materials with
• Automated frequency depending on the particular use of the equipment and
• blood gas manufacturer’s recommendation.
• electrolyte
• glucose
• oxygen
• protein
3. Atomic absorption 6 monthly: Check for sensitivity, baseline variation, background
spectrophotometers correction, and optimisation parameters.
4. Autoclaves (a) When used: Check for temperature and pressure on display.
(b) Use autoclave tape to check performance; use biological
indicator where appropriate.
(c) Every 2 years: Calibrate gauges.
(d) Register with the Ministry of Manpower.
5. Balances and scales (a) When used: Zero point check.
(b) Yearly: Calibration by accredited calibration laboratory for
repeatability, linearity and accuracy. Use 10 weighing of a
mass having a value close to the maximum load of balance.
6. Biological Safety Yearly: Certified to ensure filters are functioning properly and that
Cabinet & Laminar flow airflow rate meet specifications.
7. Centrifuges Yearly:
(a) Check temperature using a calibrated thermistor, or more
frequently if required, and
(b) Check speed using a calibrated tachometer.
8. Chromatography, Gas Instrument must be routinely monitored during use with standard
reference materials. System components (e.g. integrators, ovens,
electronic amplifiers and detectors) must also be checked
periodically, and records kept.
9. Chromatography, Liquid chromatography, including high performance (or high
Liquid & (HPLC) pressure) liquid chromatography (HPLC) and ion chromatography :

The total system must be monitored during use with reference

standards. Loss of efficiency may be detected by chronological
comparison of reference material measurements. System
components (e.g. pumping system and detectors) must be subject to
periodic checks and details must be recorded.
10. Counter Each use: Check using appropriate controls and standard materials
 beta
 cell
 gamma

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S/N Type of Instrument Maximum Period Between Successive Calibrations or

or Equipment Performance Checks
 particle size
11. Deionizers (a) Daily or when used: Check for conductivity using conductivity
meter.
(b) 6 monthly: Check for sterility
12. Densitometers 6 monthly: Check for linearity.
13. DNA-sizing equipment Instrument performance must be routinely monitored during use with
control samples.
14. Electrophoresis Instrument performance must be routinely monitored using the
appropriate controls. System components (e.g. electrodes, tank and
power supply), must be checked periodically.
15. Flame photometers Each use: Check using appropriate controls and standard materials.
16. Freezers (a) Daily: Check temperature using a thermometer.
(b) Yearly: Check temperature with a reference thermometer.
17. Glassware (a) Volumetric glassware (burettes, pipettes, and volumetric flasks).
Once – before first use.
(b) Volumetric glassware for general use. Need and extent of
calibration to be appropriate for intended use.
18. Haematocrits Yearly: Check speed using a calibrated tachometer.
19. Haemoglobinometers Twice weekly: Check using the appropriate controls and standard
materials.
20. Heating Baths Daily or When used: Check temperature with a thermometer.
21. Heating Blocks For use analytical measurement or critical procedure: each day of
use - by thermometer.
22. Incubators (a) Daily: check for temperature, using a calibrated thermometer.
To maintain temperature to accuracy of ± 2oC or within a given
range as stipulated in methods.
(b) Yearly: temperature checks, using a reference thermometer.
(c) Carbon dioxide incubator (microbiology): check carbon dioxide
content daily using built-in gauge; 6 monthly using fyrite device
or equivalent device.
23. Manometers (a) Reference: 10 years (complete) and check fluid every 3 years.
(b) Working : 3 years (Check against reference)
24. Masses Reference: 3 years initial, 6 years subsequent.
25. Microscopes (a) Regular cleaning and maintenance. Clean stage and lenses
after use.
(b) Yearly: Service maintenance.
26. Microscopes, (a) Check for the used time of UV bulb. Bulb should be changed
Fluorescent when time reaches 200-300 hours or depending on life-span of
bulb.
(b) Yearly: Service maintenance.
27. Ovens (a) Drying oven. By thermometer – frequency appropriate to use.
(b) Sterilizing oven (Hot air oven). Daily using thermometer.
28. pH Meters Daily or When used: Check for accuracy. Bracket pH value expected
as closely as possible with buffers.
29. Piston-operated Every 6 months: For gravimetric checks, volume delivery and
volumetric apparatus weighing under specified conditions must be repeated at least 10
 Pipettes and times. For adjustable devices check volume delivered at several

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S/N Type of Instrument Maximum Period Between Successive Calibrations or

or Equipment Performance Checks
Dispensers settings. Delivery of volumes less than 100uL may be verified by
spectrometry using a dye solution.
30. Refrigerators (a) Daily: Temperature checks, using calibrated thermometer.
(b) Yearly: Temperature checks, using reference thermometer.
31. Spectrophotometers 6 monthly:
 UV–visible (a) Wavelength accuracy and reproducibility. Run two spectra.
Spectrophotometer (b) Photometric accuracy and reproducibility.
/ colorimeter
32. Sterilizers, gas Each use: Using biological indicators.
33. Stop Watches Yearly: Calibration by accredited calibration organisation.
34. Tachometers (a) Reference: 5 years
(b) Working : Once a year
35. Thermocouples Yearly: calibration by accredited calibration organisation.
36. Thermometers (a) Reference :
 2 Yearly: Specific points check by accredited calibration
organisation.
(b) Working :
 Yearly: Temperature is checked at specific point using
reference thermometer.
37. Timing Devices Yearly: Verification.
38. Temperature-controlled The performance of water baths, incubators, ovens and refrigerators
equipment must be monitored continuously to ensure compliance with the
temperature requirements of test methods.

Accordingly, daily-recorded checks of the temperature within the load

space of these items of equipment must be maintained.

The thermometers used to monitor the performance of temperature-

controlled equipment must be of sufficient accuracy to ensure that
this equipment complies with the temperature tolerances specified in
the test methods.

The spatial distribution of temperature throughout the load space of

temperature-controlled equipment may be checked following
installation of equipment ant at appropriate intervals thereafter.

Temperature recording devices must be checked at yearly intervals

against at reference thermometer and the results recorded.
39. Water Bath Daily or when used: Check the temperature using a calibrated
thermometer contained in water bath.

Maintain the accuracy of ±1oC of the requirement. Record water bath

thermometer correction factor and attach to water bath.
40. Water purifiers (a) Daily or When used: In-line check for conductivity. For
instruments without in-line checks: weekly off-line check for
conductivity.
(b) 6 monthly: Check for sterility.

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References:

1. ACGS General Genetic Laboratory Reporting Recommendations

(http://www.acgs.uk.com/media/949852/acgs_general_genetic_laboratory_reporting_recomm
endations_2015.pdf).

2. American College of Medical Genetics – Standards and Guidelines for Clinical Genetics
Laboratories 2008 Edition.

3. College of Pathologists, Academy of Medicine Malaysia Guideline on Retention of Pathology

Records and Materials.

4. EMQN Best Practice (https://www.emqn.org/emqn/Best+Practice).

5. Establishing Molecular Testing in Clinical Laboratory Environments, Approved Guideline

(CLSI).

6. Guidelines on Chemical Management in Health Care Facilities Ministry of Health 2010

(http://www.moh.gov.my/images/gallery/Garispanduan/Guidelines_on_Chemical-1.pdf).

7. Human Genome Variation Society (HGVS) Nomenclature (http://www.hgvs.org/mutnomen/).

8. ILAC G 24- Guidelines for the Determination of Calibration Intervals of Measuring Instruments.

9. MS 2370 – Medical Laboratories – Reduction of Error through Risk Management and

Continual Improvement.

10. MS ISO 15189 – Medical Laboratories – Requirements for Quality and Competence.

11. MS ISO 31000 – Risk Management – Principles and Guidelines on Implementation.

12. MS IEC/ISO 31010 – Risk Management – Risk Assessment Techniques.

13. MS ISO Guide 73 – Risk Management – Vocabulary.

14. Occupational Safety and Health (Use and Standard of Exposure Chemical Hazardous to
Health) Regulations 2000 (USECHH Regulations)
(http://www.dosh.gov.my/index.php/en/legislation/regulations-1/osha-1994-act-154/522-pua-
131-2000-1/file).

15. Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous
Chemicals) Regulations 2013 (CLASS Regulations)
(http://www.federalgazette.agc.gov.my/outputp/pua_20131011_P%20U%20%20%28A%29%2
0310-peraturan-
peraturan%20keselamatan%20dan%20kesihatan%20pekerjaan%20%28pengelasan%20pela
belan%20dan%20helaian%20data%20keselamatan%20bahan%20kimia%20berbahaya%29%
202013.pdf).

16. Recommendations for Reporting Results of Diagnostic Genetic Testing (Biochemical,

Cytogenetic and Molecular Genetic), M Claustres et al., European Journal of Human
Genetics (2014) 22, 160–170.

17. SAMM Policy 2 – Policy on the Traceability of Measurement Results.

Issue 1, 14 November 2017 Page 19 of 21

 SC 2.1: SPECIFIC CRITERIA FOR ACCREDITATION IN THE FIELD OF MEDICAL MOLECULAR TESTING

18. SAMM Policy 4 – Policy for Participation in Proficiency Testing Activities.

19. WHO Laboratory Biosafety Manual (http://www.who.int/en/).

Issue 1, 14 November 2017 Page 20 of 21

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Acknowledgements

1. Prof. Dr. Yasmin Abdul Malik (Chairman) Standards Malaysia

2. Ms. Noraidah Hj. Subakin (Secretary) Standards Malaysia

3. Ms. Fariza Wan Abdullah Standards Malaysia

4. Dr. Zubaidah Zakaria Institut Penyelidikan Perubatan (IMR)

5. Dr. Wong Yong Wee DNA Laboratories Sdn. Bhd.

6. Dr. Roziana Ariffin Hospital Kuala Lumpur

7. Ms. Yusnita Yakob Institut Penyelidikan Perubatan (IMR)

8. Prof. Dato’ Dr. Mohd Zaki Salleh iPROMISE, UiTM

9. Dr. Tengku Shahrul Anuar Tengku Ahmad Basri iPROMISE, UiTM

10. Prof. Dr. Zulqarnain Mohamed Universiti Malaya

11. Prof. Dr. Roslan Harun KPJ Ampang Puteri Specialist Hospital

12. Prof. Datin Dr. Zahurin Mohamed Universiti Malaya

13. Assoc. Prof. Dr. Abhimanyu Veerakumarasivam Universiti Perdana

14. Dr. Baizurah Mohd Hussain Hospital Ampang

15. Dr. Arni Talib Hospital Kuala Lumpur

16. Prof. Dr. Rosline Hassan Hospital Universiti Sains Malaysia (HUSM)

17. Dr, Masita Arip Institut Penyelidikan Perubatan (IMR)

18. Dr. Lim Chun Ren GeneNews (M) Sdn. Bhd.

19. Dr. S. Geetha Subramaniam Geneflux Molecular Diagnostics Centre

20. Ms. Rohasmizah Ismail Standards Malaysia

21. Ms. Siti Norehan Ishak Standards Malaysia

22. Ms. Norsheda Mohd Bahari Standards Malaysia

Issue 1, 14 November 2017 Page 21 of 21