L b

Laboratory Accreditation I & II
A di i I & II
HKU SPACE
Higher Certificate in Medical Laboratory Science
Laboratory Management
Laboratory Management
Vanessa Lo
Vanessa Lo
Adjunct Lecturer
Clinical Scientist, FFSc (RCPA)
6 & 9 September 2022 (6:30 – 9:30 pm)
6 & 9 September 2022 (6:30 – 9:30 pm)

Improved the Quality 
of Patient care

2
• LLaboratory medicine is backbone
b t di i i b kb i th
in the 
medical treatment, diagnosis and disease 
prevention
• Laboratory diagnostics 
Laboratory diagnostics
• Influences 70–80% of hospital health 
care decisions
• Costs between 3
Costs between 3–5%5% of total health 
of total health
care costs
• Laboratory attempts to improve quality 
by …
by …

1. Reduce errors  Reduce cost 
 Shorten TAT
 Serve more 
2. Shorten TAT 
h
patients
3 Enable traceability of all 
3. Enable traceability of all
laboratory procedures 
Reduce errors  Shorten TAT
 Stipulate requirements for 
QUALITY and COMPETENCE of 
medical laboratory
medical laboratory

Encompass assessment 
criteria
FORM THE BASIS FOR THE
ACCREDITATION OF LABORATORIES
 Accreditation is about who has a 
QUALITY SYSTEM of S f TANDARD
PROCEDURES
NOT who is the best

QUALITY SYSTEM is about 
QUALITY SYSTEM is about
PEOPLE, with PEOPLE
, & for 
PEOPLE

ISO 15189 : 2012 Requirement
4.1 Organization and management
g g 5.1 Personnel
4.2 Quality management system Accommodation and 
5.2
4.3 Document control environmental conditions
4.4 Review of contracts 5.3 Laboratory equipment
4.5 Examination by referral laboratories 5.4 Pre‐examination procedures
4.6 External services and supplies 5.5 Examination procedures
4.7 Advisory services Assuring the quality of 
5.6
4.8 Resolution of complaints examination procedures
i ti d
Identification & control non‐
4.9 5.7 Post‐examination procedures
conformities
4.10 Corrective action  5.8 Reporting of results
4.11 Preventive actiton 5.9 Release of results
4.12 Continual improvement Laboratory information 
5.10
4.13 Quality and technical records management
4.14 Internal audits
8
4.15 Management review
4 1 Organisation & Management
4.1  Organisation & Management
Specific requirements for supervision

4 1 5 j (extracted)
4.1.5 j (extracted)
The laboratory shall document relief 
arrangements where specific supervision 
requirements have been stipulated by
requirements have been stipulated by 
the accreditation body’s requirement

4 2 Quality Management System
4.2 Quality Management System
4.2.1 (extracted)
( )
QUALITY documentation shall include or 
reference the scope of accreditation and
reference the scope of accreditation and 
a policy on the use of the accreditation 
body’s endorsement

10
4 2 4 (extracted)
4.2.4 (extracted)
• All personnel shall be instructed on the 
p
use and application of the 
• quality manual
lit l
• all referenced documents
all referenced documents
• all requirements for their 
implementation

11

4 2 Quality Management System
4.2 Quality Management System
4.2.4 (extracted) (continue)
( )( )
• The quality manual shall be
• kept up to date
• under the authority
under the authority & responsibility 
& responsibility
of an individual appointed to be 
accounted for quality by the 
laboratory management
laboratory management

12
4.3 Document Control
Document Control
• All documents are to be reviewed 
and approved by authorized 
personnel before use
personnel before use
• All documents shall carry identifying 
i f
information, including:  
ti i l di
• Title
• Unique identifier on each page
• Version date or version number
Version date or version number
• Page count e.g. Page 1 of 10
• Authority for issue 13

• Current
Current approved
approved documents are 
documents are
tracked on a document register or 
master index
t i d

• Obsolete version / document shall not 
version / document shall not
be accessible
14
4.4 Review of Contract
Review of Contract
4.4.1 (extracted)
• Request(s) ordered by the requesting 
or attending physician – paper or 
or attending physician  paper or
electronic – bed side  / ward order
• Add‐on requests –
Add verbal or paper or 
b l
electronic
• Consultancy arrangements
• Referral in / out service
Referral in / out service
• Contracts or tenders with vendors / 
suppliers 15

4.5 Examination by Referral 
Examination by Referral
Laboratories 
4.5.1 (extracted)
• A
A competent
competent referral laboratory is 
referral laboratory is
generally considered to be a 
accredited laboratory
• Information on accreditation status 
Information on accreditation status
and scope of accreditation of referral 
laboratories may be found at the 
accreditation body’ss website
accreditation body website
16
4.5.2 (extracted)
4.5.2  (extracted)
The competency, and where appropriate 
the accreditation status, of referral 
h di i f f l
g
laboratories should be regularly y
reviewed to ensure currency

17

4 5 4 (extracted)
4.5.4  (extracted)
There shall be a procedure for the follow‐
up of results not received in a timely 
fashion
LONG

18
4.6 External Services & Supplies 
External Services & Supplies
4.6.3  (extracted)
• Expiry dates of materials shall be 
recorded together with other details:
together with other details:
• Name of the material
• Manufacturer details
• Lot number
Lot number
• Storage condition etc..
• Apply identically to home made 
A l id ti ll t h d
materials
19

4.7 Advisory Services
Advisory Services
It is acknowledged that refrigeration 
equipment (refrigerators / freezers) used 
for the storage of blood and blood
for the storage of blood and blood 
products may be outside the control or 
ownership of the laboratory e.g. 
hi f th l b t
operational theatre
p

20
• The hospital or clinic that owns the 
p
refrigeration equipment shall ensure 
compliance with relevant
compliance with relevant 
requirements e.g. accreditation of the 
hospital
• The laboratory shall provide advice 
Th l b t h ll id d i
and education to the users of the 
service regarding the appropriate 
transport and storage conditions of
transport and storage conditions of 
blood and blood products
21

• This advice shall include appropriate 
pp p
monitoring and/or audit of equipment 
and procedures
and procedures

22
• Laboratories performing semen 
p g
analysis shall advise users of the 
ser ice of the minimum collection
service of the minimum collection 
requirements. These include: 
1. A record of the time of ejaculation
2. The optimal storage temperature (20
The optimal storage temperature (20‐
35oC) of the sample between collection 
and receipt into the laboratory
and receipt into the laboratory
3. The use of lubricants or condoms is 
contraindicated; and 
d d d
4. A record of whether the collection was 
complete 23

4.8 Resolution of Complaints
Resolution of Complaints
• Policy & procedures for the resolution of 
complaints or other feedback received 
l h f db k d
,p p
from clinicians, patients or other parties
• Record of complaints & investigation & 
corrective actions taken by the laboratory
corrective actions taken by the laboratory 
shall be maintained
• Encourage to obtain both positive and 
g
negative feedback from the users of 
their services, preferably in a systematic 
way e g surveys
way, e.g. surveys
24
4.9 Identification and Control of 
Identification and Control of
Non‐conformities
• Address non‐conformities identified 
properlyl
p
• Correct the immediate problem,  ,
which might be superficial
• Initiate actions according to the 
d h
requirements, including whether the
requirements, including whether the 
non‐conforming working is:
25

• An isolated incident or
• Due to some underlying causes with 
RECURRENCE possibility
RECURRENCE possibility

Establish 
procedure for
procedure for 
handling non‐
conforming works

NO Recurrence
NO Recurrence
26
4.10 Corrective Actions
4.10 Corrective Actions
4.10.1 (extracted)
• Procedures for corrective action shall 
include an investigative process to 
include an investigative process to
determine the underlying cause or 
causes of the problem
• These shall, where appropriate, lead to
These shall where appropriate lead to
preventive actions
• Corrective action shall be appropriate 
to the magnitude of the problem
to the magnitude of the problem
27

4.10.2 (extracted)
4.10.2 (extracted)
• Laboratory management shall 
IMPLEMENT d DOCUMENT ALL 
IMPLEMENT and DOCUMENT ALL
g q p
changes required to its operational 
procedures resulting from corrective 
action investigations
action investigations

28
4.11 Preventive Actions
4.11 Preventive Actions
• Preventive action is a proactive 
process to identify improvement 
opportunities, rather than a reaction
opportunities, rather than a reaction 
to the identification of problems or 
complaints
l i t
g
• Consideration should be given to 
providing staff with a formal 
mechanism for contributing 
for contributing
suggestions for improvement
29

4.12 Continual Improvements
4.12 Continual Improvements
4.12.1 (extracted)
• All operational procedures shall be 
1 systematically reviewed by 
1. t ti ll i db
laboratory management 
y g
2. at regular intervals
3. as defined in the quality 
management system
management system

30
• Identify any potential sources of non‐
y yp
conformance or other opportunities 
for impro ement in the quality
for improvement in the quality 
management system or technical 
practices
• Action plans
Action plans for improvement shall be 
for improvement shall be
developed, documented and 
implemented, as appropriate

ACT Proactively
31

4.13 Quality & Technical Records
4 13 1 (
4.13.1 (extracted)
d)
• All
All records shall include identity
records shall include identity of the 
of the
person making the record
• If more than one staff may involve in 
f h ff l
test processes or other laboratory 
p y
procedures – the laboratory shall be 
responsible to:
ibl t

32
 1 identify
1. identify the critical step(s)
the critical step(s) in the 
in the
procedure
2. ensure that the identities of the 
staff concerned are recorded
staff concerned are recorded
• Alterations to data shall include the
1. date the change was made 
2. identity of the person made the 
change
Sign & Date
g
33

4.13.2 (extracted)
4.13.2 (extracted)
As far as practicable, all
• records shall be indelible (不可磨滅)
• data or observations recorded in such 
d b i d di h
p
a manner that prevents amendment 
or loss of the original

Traceable
34
4.13.3 (extracted)
4.13.3 (extracted)
Minimum retention times (include raw 
d ) shall be in accordance with those 
data) h ll b i d ih h
p y y
specified by the accreditation body’ 
requirements

35

36
 37

4.13.3 (extracted)
4.13.3 (extracted)
• Legislative or contractual obligations 
may prescribe longer retention times
ib l i i
• No need retention where the 
transcribed report has been authorised 
by a pathologist Dictaphone
by a pathologist –
recordings of 
1. microscopic and 
2 macroscopic descriptions of tissue 
2. macroscopic descriptions of tissue
biopsies
38
• The record system
y
1. Shall include a copy of each report
that contains results of testing
that contains results of testing 
covered by the scope of 
accreditation, or 
2 Shall allow them to be reproduced, 
2. Shall allow them to be reproduced
including details such as the 
endorsement (if applicable) and 
identification of the person who
identification of the person who 
authorised the report
39

• With reference to the list of records 
under 4.13.3 a) – p) following records 
shall be retained
shall be retained:
1. Date on which the test was 
performed
2 Original test observations & 
2. Original test observations &
calculations
3. Identity of person performing the 
test
4. Identity of person reviewing quality 
control results
40
 5. Indication that calculations have 
been checked
been checked
6. Indication that manual data 
transfers have been checked;
f h b h k d
y p
7. Any other information specified in 
• the test method
• other contractual documents
other contractual documents
• relevant statutory regulations (e.g. 
PoCT)

41

4 14 Internal Audits
4.14 Internal Audits
4.14.1  (extracted)
The internal audit schedule shall cover 
both the management & technical
both the management & technical 
requirements of ISO 15189 (To be 
discussed in details later)

42
 4 15 Management Review
4.15 Mana ement Re ie
The effectiveness of the quality 
q y
management system shall be reviewed 
by management at least once every year
by management at least once every year

43

Internal Audit
Internal Audit
Periodic / Regular Check that a laboratory 
shall perform in a Planned Schedule 

44
 Management Requirements – Horizontal

45

Technical Requirements – Horizontal & Vertical 

46
Objectives
1. Verify that the quality system and 
d
documented procedures are in 
d d i
y p
conformity with the stipulated 
requirements

47

2. Determine whether the operation is 
p
in compliance with the quality 
system and documented procedures
t dd t d d
3. Ensure that ALL personnel, at ALL
levels, are competent to carry out 
their assigned duties and 
their assigned duties and
responsibilities
4. Identify areas of risks where 
preventive actions may be required 
preventive actions may be required
to avoid any potential non‐
conformities
48
Ensure that every element of the quality 
system, as laid down in its quality manual 
and supporting documentations (e g SOP
and supporting documentations (e.g. SOP, 
equipment maintenance record, QC 
records etc.), are
FULLY

49

ISO 15189 Internal 
A dit TWO Ways 
Audit – TWO W
of Audit Processes
of Audit Processes

Vertical  Horizontal 
Audit Audit
50
51

52
1 Set
1. Set up an audit team
up an audit team
• Lead auditor
• Auditors
2 Prepare audit plan
2. P dit l
• Type: horizontal or vertical
Type: horizontal or vertical
• Scope
• Checklist
• Documents to be reviewed 
Documents to be reviewed

53

•Quality manual
Quality manual
•Standard operating procedures
•Corrective action request
•All
All records particularly:
d ti l l
• Personnel qualification
Personnel qualification
• Quality and technical record
• Advisory record
• Purchase & supply record etc..
Purchase & supply record etc
g
3. Make arrangement with the auditee
54
 55

Gather information about:
• Conformity of the quality system with ISO 
15189 (2012) requirements
15189 (2012) requirements
• Compliance of laboratory operation with the 
quality system e.g. SOPs, maintenance record, 
lit t SOP i t d
QC plan, equipment breakdown record etc.
Identify: 
• Breakdown
Breakdown and deficiencies in the quality 
and deficiencies in the quality
system
• Departure from the documented procedures
Departure from the documented procedures
• Any other important issues affecting service 
quality
li
56
1. Be prepare
2. Stay calm, courteous, professional and 
firm
3. Be open minded 
4 Communicate clearly
4. Communicate clearly
5. Avoid leading, multiple, tricky questions
6 Listen intently
6. Li i l
7. Be observant and take notes 
8. Document objective evidences 
9. Avoid bias
Avoid bias
10. Do not make assumption 
11 Avoid giving advice
11. Avoid giving advice
57

12. Proper documentation of audit findings in 
p g
• Audit Report 
• Audit Summary
Audit Summary
13. Submit both report and summary to the  
management for review and continuous 
tf i d ti
improvement
14. Offer a mutually accepted timeline for the 
p
auditee to submit Corrective Action Report 
with detail illustration of appropriate 
corrective and prevention actions if
corrective and prevention actions if 
deficiencies or opportunities for 
i
improvement are noted 
t t d
58
 ct o s a e o o Co o t es 1
Actions Taken for Non‐Conformities  
(4.9.1)
• NO corrective action was taken
• Corrective actions taken were NOT
Corrective actions taken were NOT
adequate to find out the root cause
• There was NO evidence that the effects 
on patient samples tested during that
on patient samples tested during that 
period had been assessed

2
Records (Traceability) (4 13 3)
Records (Traceability) (4.13.3)
No record was available for some 
examination procedures such as: 
• Identification of operator 
Identification of operator
• Counterchecking personnel
• Originall observations
b
• Ca
Calculations
cu at o s ee.g. manual dilution etc.
g a ua d ut o etc
5.1 Personnel
5.1 
5.1.1 (extracted)
Adequacy of staff number is to be 
determined by assessment as will the
determined by assessment as will the 
adequacy of supervision
5.1.9 (extracted)
• Adequate
Adequate continuing education 
continuing education
opportunity for all staff
• Accessible to appropriate reference 
texts and journals
texts and journals
61

• Any education program include in‐
y p g
house and external components
1 Regular educational presentations –
1. Regular educational presentations
cases / journal article review
2. Review of 
• QAP
QAP educational material
educational material
• interesting or abnormal – blood films 
/ histopathology & cytopathology
/ histopathology & cytopathology
slides / cultures etc.
3. Attendance at meetings, 
conferences and workshops
conferences and workshops
62
5.1.11 (extracted)
( )
• Where staff are expected to work in 
areas other than those in which they 
th th th i hi h th
would normally work a program of 
y p g
regular refresher training shall be 
established
1. On call
2. Shift duty in core laboratory 
covering wide service scope
covering wide service scope
3. Weekend / public holidays duty
63

5.2  Accommodation and 
5.2 Accommodation and
Environmental Condition
• Occupational safety and health 
(OSH)
• A Safety Manual detailing the 
laboratory’s policies and procedures 
in relation to health and safety shall
in relation to health and safety shall 
be readily available to all staff
• I
Importance of safe laboratory 
t f f l b t
practice shall be emphasized
p p
64
5.3 Laboratory Equipment
5.3  Laboratory Equipment

65

5.4 Pre‐examination
5.4 Pre examination Procedure
Procedure
5.4.2 (extracted) – Documented 
instructions for self‐collected samples 
(e.g. midstream urine, semen) shall be in
(e.g. midstream urine, semen) shall be in 
languages appropriate for the patient 
population 
l i
5 4 4 3 (extracted) – The laboratory
5.4.4.3 (extracted) – The laboratory’ss 
collection procedures shall include order 
of draw to avoid cross contamination of 
additives between tubes
additives between tubes
66
Order of Draw
Order of Draw

67

5 4 4 3 a (extracted)
5.4.4.3 a (extracted) 
On presentation for collection, all patients
shall be positively identified by collector 
e g by asking 'What
e.g. by asking  What is your name?
is your name?'

68
5 4 4 3 e (extracted)
5.4.4.3 e (extracted)
• When identifying the patient, 3 unique 
identifiers shall be used on the request 
form
• A minimum of 2 unique identifiers is 
allowed for unidentifiable and 
ll df id ifi bl d
unconscious patients
p
• Hospital admission number
• Medical record number
Medical record number
• Sex etc.
69

• Sample
Sample collection containers shall NOT 
collection containers shall NOT
be labelled before collection
• Sample collection containers shall be 
S l ll i i h ll b
p p
labelled in presence of the patient,  ,
and if possible, the patient identifiers 
sho ld be confirmed b the patient
should be confirmed by the patient
• Same as request form, sample label 
should contain 3 unique identifiers, if 
not 2 is a shall
not, 2 is a shall
• Example of identifier: Name, ID No, 
DOB, Sex/Age 70
• Patient’s
Patient s sample without 2 identifiers 
sample without 2 identifiers
are considered to be inadequately 
l b ll d
labelled
• Identifiers on the request form shall be  
q
concordance with those on the sample 
label

71

• Point‐of‐care testing
• Labelling requirements may be relaxed
• A delay in testing occurs there shall be 
A delay in testing occurs there shall be
labelling of the syringe or tube as 
above
b

72
5 4 6 (extracted)
5.4.6 (extracted)
• Samples and associated records shall 
be uniquely identified e.g. with 
laboratory request number during all
laboratory request number during all 
stages of testing
• Semen analysis
S l i
• Time of ejaculation
• Sample storage conditions between 
collection and receipt into the laboratory
collection and receipt into the laboratory
• Use of lubricants or condoms
• Collection was completeness
Collection was completeness
73

5 4 6 b (extracted)
5.4.6 b (extracted)
Documented sample reception 
procedures shall include the action to be 
taken in the event that an unsuitable
taken in the event that an unsuitable 
sample is received
5.4.6 c (extracted)
Where inadequately labelled samples are 
Wh i d t l l b ll d l
p g,
received and accepted for testing, the 
laboratory shall assure itself of the 
identity of the sample e g 2nd label
identity of the sample, e.g. 2
74
5 5 Examination Procedure
5.5 Examination Procedure
5.5.1.1 (extracted)
• Where a test can be performed by 
more than one method there shall be
more than one method there shall be 
documented criteria for method 
selection
• Degree of correlation
Degree of correlation between 
between
methods shall be 
• established and 
• documented
75

• M
Method selected should be identified 
th d l t d h ld b id tifi d
on the test report, e.g. Immunoassay
p , g y–
ECLIA, IN, IT, CMIA, Bacterial ID –
Chemical MALDI‐TOF etc.
Chemical, MALDI TOF etc
• Examination
Examination of blood films for malarial 
of blood films for malarial
parasites shall include evaluation of 
b h hi
both thin and thick films
d hi k fil
• Criteria
Criteria for referral of blood films to a 
for referral of blood films to a
pathologist shall be documented
76
• SSupplemental testing is required for 
l t l t ti i i df
reactive screening tests for infectious 
g
diseases including 
• HIV antibody
HIV antibody
• Hepatitis C antibody
• Hepatitis B surface antigen in 
persons not already known to be
persons not already known to be 
infected
• COVID‐19 – SARS‐CoV‐2 antigen, 
RNA and antibody
RNA and antibody
77

• Validation / verification
/ of automated 
semen analyser shall be performed
semen analyser shall be performed 
against the 
• WHO Laboratory Manual for
• the Examination and Processing of 
the Examination and Processing of
Human Semen Cervical Mucus 
Interaction
• 5th Edition World Health 
5th Edition World Health
Organisation
78
• Calibration of such analysers, not just 
count with bead suspensions, shall be
count with bead suspensions, shall be 
performed against the three principal 
sperm parameters
t
• Count
• Motility
• Morphology
• Quality
Quality Control procedures
Control procedures shall be 
shall be
appropriate to the technology used
79

• Where
Where laboratories are performing 
laboratories are performing
drugs of abuse testing for clinical us,  
the cut‐off levels
h ff l l shall be in‐line with 
h ll b i li ih
that of local standards with 
documentary proof Cannabis
Cocaine
C i
Ketamine
MDMA (Ecstacy)
Methamphetamine 
(Ice)
Nimetazepam
80
5.5  Examination Procedure
5.5.1.2 and 5.5.1.3 (extracted)

81

Verification 
Verification
Typically less 
extensive
t i and  d
Commonly  demonstrate the 
Ad t d i
Adopted in  user’s ability to 
achieve the 
Medical
Medical  published 
Testing
Testing  performance
performance 
characteristics of a 
Laboratories method under the
method under the 
user’s own test 
conditions. 
82
 Validation
Validation  A laboratory developed 
A laboratory developed
Provide objective  test (LDT) – A type of in 
evidence that an in‐
id th t i vitro diagnostic test that
vitro diagnostic test that 
is designed, 
house method or 
manufactured and used
manufactured and used 
modified standard  within a single 
method is fit for the  laboratory
laboratory.
purpose and 
satisfies the
satisfies the 
particular 
requirements for its 
i t f it
specific intended 
use. 
83

Introduction of new methodology
Introduction of new methodology
• Appropriate records of validation / 
verification
ifi i
• The documentation of the 
validation/verification process shall 
include the following:
include the following: 
• Proposed sample types
• Source of reference material 
• Sample acceptance/rejection 
Sample acceptance/rejection
criteria
• Formal evaluation of data collected 84
 • Minimum
Minimum sample number 
sample number
requirements
• Final summary of results including 
recommendations for example the
recommendations, for example, the 
suitability of the method for use in 
the laboratory and any relevant 
limitations of the method
limitations of the method 
• Formal authorisation (sign‐off) by 
supervisory staff
i ff

85

• Verification
Verification of methods prior to use 
of methods prior to use
shall include statistical correlation with 
existing validated methods in graphical 
i i lid d h d i hi l
representation
p
• Statistical methods
• Correlation –
Correlation Deming Regression, 
Deming Regression
Passing Bablok
• Bias – Bland and Altman Plot 
(Difference Plot)
(Difference Plot)
• A statistically significant number of 
samples shall be used 86
 Statistically Significant Sample Number 
y g p
[Reference Interval Verification – All]

20 M+F If FAILED 60 M+F

[Reference Interval Verification – SEX 
Dependent]

20M + 20F
20M + 20F If FAILED
If FAILED 60M+ 60F
60M+ 60F
87

[[Reference Interval Establishment – All]]
120 M+FF
120 M
[Reference Interval Establishment –
[Reference Interval Establishment – SEX
Dependent]

120 M + 120F
[Method Verification Study]
[Method Verification Study]

40
88
• These
These shall cover the full range of 
shall cover the full range of
results for the intended use of the 
assay (e.g. AFP)
( AFP)
• For quantitative assay both accuracy 
q y y
and precision shall be determined
• For qualitative and semi‐quantitative 
For qualitative and semi quantitative
assay conduct concordance studies 
with existing validated methods
• Clinical sensitivity and specificity shall 
Clinical sensitivity and specificity shall
be evaluated in specific, local patient 
populations 89

Molecular Pathology Assays (LDT)
Molecular Pathology Assays (LDT)
• Well known that lengthy time is 
required to validate
i d lid t in‐house molecular 
i h l l
p
pathology assays, nevertheless, 
gy y, ,
accreditation cannot be granted to 
incompletely validated assays
incompletely validated assays
• Where the results of such assays are 
reported, following comment, or 
similar shall be included in the test
similar, shall be included in the test 
report: 
90
• “This assay is still undergoing 
development and is not yet fully
development and is not yet fully 
validated.
• Results shall be interpreted in 
association with all other information
association with all other information 
(clinical and laboratory) of the patient. 
• Reports based on this assay are NOT  
currently [Name of Accreditation
currently [Name of Accreditation 
Body] endorsed.” 
91

5 5 1 4 ( t t d)
5.5.1.4 (extracted)
Uncertainty of Measurement (UOM) / 
y ( )/
Measurement Uncertainty (MU)

MU = 1.96 x CV (%)
Which assay had a higher MU?

92
5 5 2 ( t t d)
5.5.2 (extracted)
Biological reference intervals and/or 
g /
medical decision points verification

93

R
Reagent Change
t Ch
• Lot
• Version
• Formulation

94
5 5 3 ( t t d)
5.5.3 (extracted)

Methodology
gy

Standard 
Operating
Operating 
Procedure Sign & Date

95

96
5.6 
5 6 Ensuring Quality of 
Ensuring Quality of
Examination Results 
5.6.2  Internal Quality Control (IQC) 
(extracted) – All Disciplines
• IQC
IQC material shall cover
material shall cover
• Patient analytical concentrations
• The critical clinical action points e.g. 
fasting blood glucose 2 – 3 mmol/L, 
fasting blood glucose 2  3 mmol/L
clinically critical / significant level
• Representing clinical levels
97

• Low vs. Middle vs. High
Low vs. Middle vs. High
• Normal vs. Abnormal
• Positive vs Negative
Positive vs. Negative
• Reactive vs. Non‐reactive
• Third Party QC materials –
Independent of those produced by the 
of those produced by the
manufacturer of the test or analyser 
• Self‐establish IQC range –
manufacturer range might be TOO
manufacturer range might be TOO 
WIDE and TOO LOOSE to provide 
adequate control, i.e. not sensitive
d t t l i t iti
98
• Run‐in
Run in new lot IQC in parallel with the 
new lot IQC in parallel with the
current lot, establish tentative range 
and verify after gathering more data
d if f h i d
y
• Base on the laboratory current 
analytical performance – define 
acceptance ranges (confidence limits) 
acceptance ranges (confidence limits)
for each lot of IQC material
• Adopt pooled patient samples as IQC 
material if commercial QC material is
material if commercial QC material is 
not available
99

100
Chemical Pathology / Clinical Chemistry
Chemical Pathology / Clinical Chemistry
• Matrix matched control material
• Test frequency depends on assay 
Test frequency depends on assay
performance (sigma matric principle)
Hematology
• Run
Run multi‐level controls concurrently at 
multi level controls concurrently at
least once daily
Microbiology
• Culture
Culture media
media
• Maintain Microbiological Reference Culture 
C ll ti
Collections (MRCC)
(MRCC)
101

Histopathology
• Test control slides with special stains
• Secure sample identification through all 
stages of processing
stages of processing
Cytopathology
• Issue screening report of 'no malignant, 
yp y
atypical or other abnormal cells'  by 
appropriately trained scientist or senior 
cytotechnologist under the supervision of
cytotechnologist under the supervision of 
an appropriately trained pathologist

102
Immunology
• A positive and negative reaction shall be 
demonstrated as
1. a minimum on every immuno‐
fluorescence run
2. an optimum with every immuno
an optimum with every immuno‐
fluorescence slide

103

5.6.2 External Quality Assurance 
5 6 2 External Quality Assurance
Programs (EQAPs) / Proficiency 
Testing (PT) (extracted)
• TTest EQAP samples in a manner similar 
t EQAP l i i il
p p
to patient samples
• Submission of results according to 
schedule as a compliance assessment 
h d l li t
of turn around time
• Review ALL returned results with all 
staff accordingly 
t ff di l
104
• Discuss ALL returned results with all 
staff accordingly
t ff di l
p
• Consider implication of unsatisfactory y
EQAP performance as patient results
• Make optimal use of EQAP program as 
k l f
a valuable source and treasure 
learning materials for continuous 
i
improvement t

105

5 8 Reporting of Results
5.8  Reporting of Results
5.8.3 (extracted)
( )
Test reports shall include:
• Test sample’s laboratory number or 
other unique identifier
other unique identifier
• Each page of a multi‐page document 
shall bear a statement of the page 
number and the total number of pages
number and the total number of pages 
i.e. page X of (total no. of pages)
106
• Reports
Reports on results from tests covered 
on results from tests covered
by the scope of accreditation shall 
i l d h
include the
1. Name in which accreditation is 
Name in which accreditation is
held and 
2. The accreditation number
5 8 3 (extracted)
5.8.3 (extracted)
Report from referral laboratory –
p y name of 
the referral laboratory shall be clearly 
identified on the test report
identified on the test report
107

583 (
5.8.3g (extracted)
d)
• Serum
Serum / plasma
/ plasma shall be indicated and 
shall be indicated and
associated with different reference 
interval of potassium
• Source of sample shall be noted for 
Source of sample shall be noted for
result interpretation e.g. stone 
whether it was gall stone or renal stone

108
5.8.3i (extracted)
5.8.3i (extracted)
Interpretative comment for
• Unlabelled, mislabelled or insufficiently 
labelled sample was accepted for testing
p p g
• Reporting of drugs of abuse by primary 
screen determined by immunoassay or
screen determined by immunoassay or 
HPLC etc. but not yet confirmed by GCMS
• Fluid
Fl id requested for analysis only validated 
t df l i l lid t d
for serum or plasma by manufacturer but 
not for fluid e.g. lactate dehydrogenase level 
p
in pleural fluid
109

5 9 Release of Results
5.9  Release of Results
5.9.1 (extracted)
( )
• The laboratory shall have a 
d
documented protocol for the verbal 
d lf h b l
release of results
• Test reports may be electronically
issued (including from a site other than
issued (including from a site other than 
the accredited laboratory) provided 
that the reports have been 
appropriately authorised for release
appropriately authorised for release
110
• Copies of test reports shall be retained 
of test reports shall be retained
at the accredited laboratory including 
any handwritten comments added to 
h d i dd d
p , p
issued reports, these reports include
• Hard copy or 
• Computer records
Comp ter records
• The laboratory shall control over the 
electronic generation, access, storage 
and backup of results and reports and
and backup of results and reports and 
program controls such as password 
protection 111

• If
If the report is to be accessed from a 
h i b df
y g
website by the client e.g. electronic 
health record, there shall be an 
appropriate control in place to ensure
appropriate control in place to ensure 
the report can only be downloaded in 
a protected format
5.9.1d (extracted)
d( d)
• Preliminary
Preliminary report
report may be issued 
may be issued
when:
112
 1 Components
1. Components of a test or suite of 
of a test or suite of
tests have not yet been completed
2. Reported results shall be checked 
and authorised
and authorised
3. Report shall indicate that it is a 
preliminary
• Final
Final report whenever issued shall 
report hene er iss ed shall
contain a reference to the preliminary 
report released before

113

593(
5.9.3 (extracted)
d)
Revised report includes:
Revised report includes:
1. Amendment / Supplementary
2 Clearly identifies as a revision
2. Cl l id tifi ii
3. Includes reference to the date and 
patient's identity in the original 
report
4. The report reader is made aware of 
the revision such as by phone or 
clearly stated on the report
clearly stated on the report
114
5.10 Laboratory Management 
5 10 Laboratory Management
System
y
5.10.1 (extracted)
• The laboratory shall have access to the data 
and information needed to provide a service 
p
which meets the needs and requirements of 
the user
the user
• The laboratory shall have a documented 
proced re to ens re that the confidentiality
procedure to ensure that the confidentiality 
of patient information is maintained at all 
times
115

5.10.2 (extracted)
5.10.2 (extracted)
Authorities and Responsibilities
• Access patient data and information
• Enter patient data & examination results
patient data & examination results
• Change patient data or examination 
results
• Authorize the release of examination 
the release of examination
results and reports
• Report result with interpretative 
comment and professional input
comment and professional input
116
5.10.3g (extracted)
5.10.3g (extracted)
Laboratory Information System (LIS)
• Validated by the supplier
• Passed user acceptance test –
Passed user acceptance test Verified 
Verified
by
• Laboratory – Operational function
• IT department 
IT department
• Architecture both hardware and 
software
• System stability
System stability
117

• With
With any changes to the system 
any changes to the system
authorized, documented and verified 
b f
before implementation
i l t ti
y g
• Laboratory management shall be 
responsible for ensuring that the 
provider or operator of the system
provider or operator of the system 
complies with 
• all applicable requirements of this 
International Standard
International Standard
• particularly for data protection and 
security 118
 Non Conformance (NC)
Non‐Conformance (NC)

Non‐fulfillment of a 
Requirement

Most of the causes of NC are:
Most of the causes of NC are:
• Easily identifiable
• Readily correctable
119

Example 1 –
a pe Pre‐analytical
e a a yt ca
1. Collected wrong sample
2 Mislabeled or did not label sample
2. Mi l b l d did t l b l l
p
3. Stored sample incorrectlyypprior to 
testing resulted in sample could not 
be used for analysis
be used for analysis
4. Transported sample under unsuitable 
conditions that damaged the sample 
or endangered staff and public safety
or endangered staff and public safety
5. Destroyed reagents or test kits by 
improper storage
120
Example 2 –
a pe Analytical
a yt ca
1. Did not follow an established 
algorithm / standard operating 
/
procedure (e.g. HIV testing –
procedure (e.g. HIV testing 
reported ‘reactive / positive’ result 
without sent the sample to reference 
ith t t th l t f
y
laboratory for confirmation) )
2. Reported results with failed internal 
quality control performance
lit t l f

121

Example 2 –
a pe Analytical (continue)
a yt ca (co t ue)
3. Reported wrong result due to error 
associated with
i t d ith
• dilution 
• pipetting
4 Used poor quality reagent for sample 
4. Used poor quality reagent for sample
analysis
• expired 
• improperly stored
improperly stored

122
Example 3 –
a p e 3 Post‐analytical
ost a a yt ca
1. Issued report with transcription error
2 Produced illegible report caused by 
2. P d d ill ibl t db
p
poor handwriting g
3. Issued report to wrong location – Fail 
to secure patient confidentiality
to secure patient confidentiality
4. Issued report with wrong patient 
identity
5 Failed to report critical result timely 
5. Failed to report critical result timely
to either nurse or requesting doctor
6. Did not issue report
123

Equipment (5.3.2)
q p ( ) 1
• Equipment was NOT:
• maintained properly
i t i d l N t i
Not sign up OR 
OR
Signed up but did 
• shown to be capable of  not execute 
effectively
achieving the performance 
required
• Reagents were:
• NOT validated for performance
• used beyond expiry date 
used beyond expiry date
WITHOUT conducting 
performance verification
124
 2
Examination Procedure (5 5 1 5 5 2)
Examination Procedure (5.5.1, 5.5.2)
• The routine examination procedures used 
b th l b t
by the laboratory could NOT
ld NOT meet the 
t th
needs of the laboratory service – some 
steps were incorrect or not appropriate 
e g Violated maximum allowable
e.g. Violated maximum allowable 
dilution of immunoassay
• There was INADEQUATE
Th INADEQUATE documentation 
d i
of the validation / verification studyy
• Validation / verification was NOT done in 
enough detail
enough detail
125

3
Reference Interval (5.5.2, 5.5.3, 5.5.5)
Reference Interval (5 5 2 5 5 3 5 5 5)
• Reference interval validation was NOT
done
• There was NO
There was NO documentation on the 
documentation on the
study details (acceptance criteria)
• Source of the reference interval 
S f th f i t l
p
adopted was NOT documented

126
 4
Sample Collection (5.4.1, 5.4.2, 5.4.8)
Sample Collection (5 4 1 5 4 2 5 4 8)
• Incorrect or inconsistent instructions 
for sample collection and handling
5
Quality Control (5.6.1)
• The internal quality control procedure 
Th i t l lit t l d
// plan was inadequate
p q to eliminate 
mistakes in the examination process 
(SD CV)
(SD, CV)
• There was NO QC record
127

6
External Quality Assurance (5.6.4)
External Quality Assurance (5 6 4)
• EQA samples were NOT handled or 
analysed in the same way as patient 
samples
• EQA samples could NOT check the 
whole examination process –
h l i ti EQA
EQA 
p p p , y ,
sample preparation, analysis, result 
interpretation and reporting were 
conducted by a dedicated most
conducted by a dedicated most 
experienced laboratory staff
128
 1
Personnel (4.1.5, 5.1.4, 5.1.11)
Personnel (4 1 5 5 1 4 5 1 11)
• Personnel did NOT have sufficient 
training and experience for the task
• Work performed in the laboratory was 
Work performed in the laboratory was
NOT adequately monitored and 
supervised
i d
• Competency assessment 
p y
• was inappropriately conducted
• could NOT
could NOT confirm the competence 
confirm the competence
of staff for a particular TASK
129

2
Standard Operating Procedure (4.2.1, 
Standard Operating Procedure (4 2 1
5.5.3)
• Documents were NOT understood 
• Routine practice was different
Routine practice was different from the 
from the
documented procedures
• Some procedures were NOT
documented
• Procedures update were NOT 
p
communicated to staff

130
 Laboratory Equipments
Laboratory Equipments
Calibration Verification

Standard and Calibration Laboratory 
Standard and Calibration Laboratory
(SCL)
• Belong to the Innovation and 
Technology Commission
Technology Commission
• Responsible for maintaining the 
reference standards of physical 
measurements for Hong Kong
for Hong Kong
• These standards are metrologically
traceable to the International System 
of Units (SI)
of Units (SI)
• Provides calibration services to users 
of measurement standards and 
measuring instruments to ensure
measuring instruments to ensure 
measurement accuracy and proper 
metrological traceability
• Accredited by the Hong Kong 
Accredited by the Hong Kong
Laboratory Accreditation Scheme 
(HOKLAS)
• Implements a management system 
Implements a management system
that complies with the requirements of 
ISO/IEC 17025 and HOKLAS regulations
SO/ C 02 d O S l i

Temperature Measurement
Temperature Measurement
• SI unit of the fundamental physical quantity 
"temperature", or more precisely 
"thermodynamic temperature", is the Kelvin 
y p
(0 Kelvin = ‐273.15oC)
• Kelvin = Thermodynamic temperature of the 
Kelvin = Thermodynamic temperature of the
triple point of water
• T (in °C) = T (in K) ‐ 273.15
Triple Point of Water (0.0100
p ( oC))

The most important defining thermometric 
fixed point used in the calibration of 
fixed point used in the calibration of
thermometers to the International Temperature 
S l f 1990 (ITS 90) f
Scale of 1990 (ITS‐90) for practical and 
ti l d
theoretical reasons

Traceability Chart for Temperature 
Measurement
 Digital Thermometer
(1 point – Biannually – In house)
(Whole range – Every three years 
(Whole range  Every three years – Manufacturer)

Single Point Check at Ice Point –
g
(Biannually – In house)
 Temperature Loggers and Recorders
p gg

Temperature Loggers
(1 point – Biannually – In house)
(Whole range – Every three years 
(Whole range  Every three years – Manufacturer)

• The sensor is physically 
heated or cooled to a 
known temperature
• Corrections are made 
y
directly to the electronics 
connected to the 
temperature sensor
temperature sensor 
 Refrigerator with Electronic 
g
Temperature Control System

8.0 oC
2.0 – 8.0 
2.0 

Check the temperature at 
Check the temperature at
(2.0 – 8.0 oC)

Weighing Equipment
Weighing Equipment
Definition of Mass
Definition of Mass
• International System of Units (SI)
• Unit of mass : kilogram (kg)
• Defined as the mass of the 
International Prototype Kilogram
International Prototype Kilogram 
(IPK) maintained at the International 
B
Bureau of Weights and Measures 
fW i h dM
(
(BIPM) in France
)
Standard Weight

IPK is a cylinder of 39 mm 
i h i ht d 39
in height and 39 mm in 
i
diameter, made of an 
alloy consisting of 90% 
platinum and 10% of
platinum, and 10% of 
iridium (Pt‐Ir)

• A
A copy of the Prototype, no. 75
copy of the Prototype, no. 75
• Same form and material kept by the  
l b t
laboratory in France as the reference 
i F th f
measurement standard of mass for 
Hong Kong & dissemination of the unit 
of mass
of mass
• The laboratory in France can provide 
calibration services for standard 
weights of accuracy class
weights of accuracy class
• E2 (1 mg to 10 kg)
• F1 (20 kg to 50 kg)
International Organization of Legal 
Metrology (OIML)
Metrology (OIML) 
• International Recommendation R111
• Weights of accuracy classes
• E: Extra fine e.g. E2
E: Extra fine e g E2
• M: Medium e.g. M1, M2, M3
g , ,
• F: Fine e.g. F1, F2

• Classification of weights depends on
• Maximum permissible 
M i i ibl
measurement errors
• Shape
• Material
• Construction
• Surface finish
Maximum Permissible 
Measurement Errors

Balance Verification
Balance Verification
1.. Zero check –
e o c ec eaceach weighing
eg g
2. One point check – daily
3. Repeatability – biannually 
4. Pan position error – annually 
Zero check – Each weighing
g g

One point check –
p Daily 
y

Nominal mass
50 g
Maximum Permissible 
Measurement Errors

0.3 mg = 0.0003 g

One point check –
p Daily 
y

0.0001 < 0.0003
Repeatability –
p y Biannual 
Nominal mass 
Nominal mass
50, 100, 200 g

Repeatability –
p y Biannual 
Nominal Mass (g)
No.
50 100 200 Worst case 
Worst case
1 50.0000 100.0002 200.0002 repeatability
2 50.0002 100.0002 200.0003
3 50.0002 100.0002 200.0001
2.26 x 0.000103 
4 50.0002 100.0002 200.0002
5 50.0000 100.0000 200.0000
= 0.000233
0 000233
6 50.0001 100.0001 200.0001
7 50.0001 100.0001 200.0002
8 50.0001 100.0003 200.0000
9 50.0002 100.0002 200.0001
10 50.0002 100.0001 200.0001
Mean 50.00013
0 000 3 100.00016
00 000 6 200 000 2
200.00012
SD 0.000082 0.000084 0.000103
Maximum Permissible 
Measurement Errors

1 mg = 0 001 g
1 mg = 0.001 g

Repeatability – Biannual 
Repeatability  Biannual
Nominal Mass (g)
No.
50 100 200 2.26 x 0.000103 
2 26 x 0 000103
1 50.0000 100.0002 200.0002 = 0.000233
2 50.0002 100.0002 200.0003
3 50.0002 100.0002 200.0001
4 50.0002 100.0002 200.0002 0.000233 < 0.001
5 50.0000 100.0000 200.0000
6 50.0001 100.0001 200.0001
7 50.0001 100.0001 200.0002
8 50.0001 100.0003 200.0000
9 50.0002 100.0002 200.0001
10 50.0002 100.0001 200.0001
Mean 50.00013
0 000 3 100.00016
00 000 6 200.00012
200 000 2
SD 0.000082 0.000084 0.000103
 Pan Position Error – Annually
Pan Position Error 
50 gg Position Reading (g)
g (g) Reading ‐
g Average centre (g)
g (g)

0 (center) 49.9999 ‐
1 49.9999 ‐ 0.0001
2 50.0001 0.0001
3 49.9998 ‐ 0.0002 (largest)
4 50.0000 0.0000
0 (center) 50.0001 ‐
A
Average center
t 50 0000
50.0000
Pan position error (ABS) 0.0002
Nominal mass 50.0000
Balance resolution 0.0001

Pass if <3 x balance resolution = 
Pass if <3 x balance resolution =
0.0003

Pipette
Method 1 – Volumetric Method
• For volume above 20L
• Requires a measurement standard 
i d d
(
(calibrated) volumetric measure
)
• The volume of the test volumetric 
vessel is determined from the number 
l d df h b
of "dumps" of the measurement 
p
standard measure required to fill the 
t t
test measure
Method 2 – Gravimetric Method
Method 2 –
• For volume below 20L
• Determines the mass of water either 
contained or delivered from a test 
t i d d li df t t
measure
• From the measured mass, the volume 
can be determined with a knowledge 
b d t i d ith k l d
of water density and corrections for 
y
air buoyancy and thermal expansion 
of the vessel
of the vessel

Volumetric 
o u et c Gravimetric
G a et c
Method Method
Method Gravimetric Method
Method –
Water density – temperature dependent
Water density  temperature dependent
• 19°C  998.402 kg/m³
• 20°C  998.201 kg/m³
• 21°C  997.990 kg/m³

Pass Criteria (Fixed Volume)

Pass Criteria (Fixed Volume)

According to manufacturer’s 
According to manufacturer’s
specification
Pass Criteria (Adjustable Volume)
Pass Criteria (Adjustable Volume)

Three
Three 
volumes

According to manufacturer’s 
According to manufacturer’s
specification

Speed Check – Annually 

Speed Check  Annually
Tachometer

Pass
Pass 
Criteria
According to 
According to
manufacturer’s 
specification
ifi ti