Iso 15189

ISO 15189 : 2012
Technical Requirements
the how to
KALA DEVI NADARAJAN
BSc. Hons, MBA
29th Aug 2016
1
Learning Objective For Today
1. Read the key words in each clause

(ISO 15189, STR 2.3, SC 2, guideline on retention of
pathology & materials, college of pathologist)
2. Dissect, decode and interpret of each

clause
3. The practical what/how to do in lab

2
Terminology
Normative statements
These are statements within the standard that
are REQUIRED. They use the word SHALL
which is understood to mean MUST.
3
Terminology
Informative statements
These are statements within the standard that

are used for recommendations or guidance.
They use the words such as MAY or
SHOULD or CAN or IT IS
RECOMMENDED THAT. These are not
requirements, but should be considered as
helpful advice.
4
Terminology
Conditional statements
In some situations, Terms such as TO THE EXTENT

POSSIBLE are used with normative clauses. This
means that the requirement would apply, unless there
is an extenuating circumstance, such as a over-riding
national regulation which would take priority.
5
Terminology
Documented procedures(s)
This means that procedure is established,
documented, implemented and maintained.
A single document may address the

requirements for more than one procedure or
alternately the requirement for a documented
procedure may be covered by more than one
document.
6
Terminology
Examination :
set of operations having the object of determining
the value or characteristics of a property.
Examination procedures :
Set of operations, described specifically, used in
the performance of examinations according to
a given method.
7
Inspiring Story
8
Focusing on ISO 15189 QMS
Requirements
Management Requirement = 15
Technical Requirements = 10
The ISO 15189 identifies what needs to be done,

it is not prescriptive in how to do it!!
As busy laboratory scientists, it is difficult to see

25 requirements become integrated.
Heres where the Demings cycle provides a basic structure

for organizing and implementing a QMS
9
The Deming Cycle
Plan
Act Do
Check
10
10
The Deming Cycle
Act Management Plan

Responsibility
Measure, Resource
Analyze & Management
Improve
Check Do
Service
Realization 11
11
12
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment, reagent, &
consumables
5.4 Pre-Examination Processes
5.5 Examination Processes
5.6 Ensuring quality of examination results
5.7 Post - examination Processes
5.8 Reporting of Results
5.9 Release of Results
5.10 Laboratory Information Management 13
5.1 Personnel
14
5.1 Personnel
ISO 15189:2007 ISO 15189:2012
5.1 Personnel 5.1 Personnel

5.1.1 General
5.1.2 Personnel Qualifications
5.1.3 Job descriptions
5.1.4 Personnel introduction to the organizational
environment
5.1.5 Training
5.1.6 Competence assessment
5.1.7 Reviews of staff performance
5.1.8 Continuing education and professional
development
5.1.9 Personnel records
15
16
17
5.1 Personnel
5.1.1 General
documented procedure for personnel
management and maintain records
Key words documented procedure for personnel

management and maintain records
The work Check in the QM (dr raja elinas lecture),

-It should say generally about training,
orientation, organisation chart, courses,
competency, safety & health, CME, LIS
training,
Aku janji
18
5.1 Personnel
5.1.2 Personnel Qualifications
Key words -document personnel qualifications for each position
- Personnel making judgments have the applicable

theoretical and practical background and expertise
The work check the STR 2.4 and SC (page 8)
19
5.1 Personnel
5.1.3 Job descriptions
Key Job descriptions that describe

words responsibilities, authorities and
tasks for all personnel.
The work Fail Meja, Carta organisasi
20
5.1 Personnel
5.1.4 Personnel introduction to the
organizational environment
Key words a program to introduce new staff to the

organization
The work Kursus orientasi , keep the

attendance list
21
5.1 Personnel
5.1.5 Training
Key words a) QMS
b) QP, WI
c) LIS
d) Health & Safety
e) Ethics
f) Patient confidentiality
- The effectiveness of the training prog shall be periodically reviewed
The -Develop a training module which encompass all the above areas.
work Example of the training module.
-Department should have a QP on training Example of QP

- Stipulate in the QP when to conduct the competency assessment .
22
5.1 Personnel
5.1.6 Competence assessment
Key words -Assess the competence of each person to perform assigned

managerial or technical tasks
-Reassessment shall take place at regular intervals. Retraining
shall occur when necessary
The work - Develop a competency assessment module based on the

training module
-Department should have a QP on training & competency
- Example of QP
-Example of the competency module
- Check Pg 18 of SC- reassessed at least once a year.
23
5.1 Personnel
5.1.7 Reviews of staff performance
Key words Reviews of staff performance consider the needs of lab and
individual maintain or improve the quality of service and
encourage productive working relationships
Note: Staff performing reviews should receive appropriate

training.
The work Check with Sheila from Canada. She was part
of the ISO working committee
24
Standard performance appraisals (Penilaian Prestasi ) must include elements
that meet this clause. The typical elements of performance appraisal:
No Elements Characteristics Requirements
A Quality and quantity of Accuracy, thoroughness, the lab shall ensure that reviews of
work productivity staff performance
consider the needs of the laboratory
B Communication and Teamwork, cooperation, encourage productive working
interpersonal skills empathy relationships
C Planning and Goal setting, prioritizing the lab shall ensure that reviews of
organization staff performance
consider the needs of the individual
E Leadership Collaboration, delegation, encourage productive working
mentoring relationships
F Attitude Reliability, flexibility, initiative in order to maintain or improve the
quality of service given
to the users, encourage productive
working relationships
G Ethics Reliability, flexibility, initiative in order to maintain or improve the
to the users
H Problem solving Innovation, receptiveness in order to maintain or improve the
to the users
I Self-development and Learning, advancement, career
growth planning 25
5.1 Personnel
5.1.8 Continuing education and professional development
Key Shall be periodically reviewed. Personnel shall take part in

words regular professional development or other professional
liaison activities
Check n SC pg 18
Technical spend at least 5 hours in each 3 months period
participating in these activities.
The work 1) Create a schedule for lab CME. Every 2/3 weeks hold a CME on
various topic or review the QP/WI. see example
2) Create a schedule for the CME hospital level
3) Arrange for staff to attend MACB, MIMLS, any 1 day seminar,
even half day or 1 hour lecture and workshops
4) The most important must have 1 officer and a MLT in charge of
training.
26
5.1Personnel 5.1.9 Personnel records
Records of the relevant educational and professional qualifications, training and

experience, and assessments of competence of all personnel shall be maintained.
These records shall be readily available to relevant personnel and shall

include but not be limited to:
a) Educational & professional qualifications;

b) Copy of certification or license, when applicable;
c) Previous work experience
d) Job descriptions
e) Introduction of new staff to laboratory environment
f) Training in current job tasks;
g) Competency assessments;
h) Records of continuing education and achievements;
i) Reviews of staff performance;
j) Reports of accidents and exposure to occupational hazards
k) Immunisation status, when relevant to assigned duties
Note: the records listed above are not required to be stored in the laboratory, but can be
maintained in other specified locations, providing they remain accessible as needed.
27
5.2 Accommodation and
environmental conditions
28
ISO 15189:2007 ISO 15189:2012
5.2 Accommodation 5.2 Accommodation and environmental

And
conditions
5.2.1 General
5.2.2 Laboratory and office facilities
5.2.3 Storage facilities
5.2.4 Staff facilities
5.2.5 Patient sample collection facilities
5.2.6 Facility maintenance and
29
5.2 Accommodation and environmental
conditions
5.2.1 General
Key Shall have space allocated for the performance

words of its work
The work Emphasis on adequacy of space to ensure safety

of users, visitors and patients
Sample collection facilities and POCT are also

included
30
5.2.2 Laboratory and office facilities
Key words - Controlled access

- Prevention of unauthorized access to confidential information
-Safety facilities and devices required, such as eyewash and emergency
showers
- Communication system
Example: operation of emergency release, intercom and alarm systems

for cold rooms and walk in freezers; accessibility of emergency
showers and eyewash
The work -Drug lab- lock and key for the lab and also the fridge
-Password protected when staff key in LIS
-Light = for agglutination test
- water = analyser test result (water quality > 2ohm)
-Waste disposal = alam flora
- Eyewash = rinse water ?
- PDN = PA system , intercom
31
5.2 Accommodation and environmental
conditions
5.2.3 Storage facilities
Key words -Storage space and conditions -Integrity of sample, reagents, supplies,
documents, equipment
-Clinical sample and materials cross contamination
-Storage and disposal facilities dangerous materials need to be stored
and disposed of appropriately
The Example of Temperature monitoring of fridge ,

work lab ambient temp monitoring
Check manufacturers recomm for analyser, reag,
supplies
Samples and reag cannot be stored together.
Chemical in drug lab keep in the yellow cabinet.
Lock !!
32
5.2 Accomodation and environmental
conditions
5.2.4 Staff facilities
Key words -washroom

Drinking water
Store to keep PPE and clothing
Space for meetings
Quiet study , rest area
33
conditions
5.2.5 Patient sample collection facilities
Key Patient sample collection facilities- privacy, disabilities

words Sample collection procedures
First aid materials for patient and staff
The Blood bank bleeding area- first aid kit

work Outpatient sample collection area- test tube not exp
34
conditions
5.2.6 Facility maintenance and
Key Work area clean and well maintained

words Monitor , control & record environments; conditions
that may impact quality of samples , patient results
and health of staff
The CHRA must be done in drug lab

work Monitor ambient temp
Cytopathology screening must give priority
for quiet and uninterrupted work
environment
35
5.3 Laboratory equipment,
reagent, & consumables
36
5.3 Laboratory equipment, reagent, & consumables
ISO 15189:2007 ISO 15189:2012

5.3 Lab Equipment 5.3 Laboratory equipment, reagent, & consumables
5.3.1 Equipment
5.3.1.1 General
5.3.1.2 Equipment acceptance testing
5.3.1.3 Equipment instruction for use
5.3.1.4 Equipment calibration & metrological traceability
5.3.1.5 Equipment- maintenance & repair
5.3.1.6 Equipment- adverse incident reporting
5.3.1.7 Equipment records
5.3.2 Reagents & Consumables
5.3.2.1 General
5.3.2.2 Reagents & Consumables reception and storage
5.3.2.3 Reagents & Consumables acceptance testing
5.3.2.4 Reagents & Consumables inventory management
5.3.2.5 Reagents & Consumables instructions for use
5.3.2.6 Reagents & Consumables- adverse incident reporting
5.3.2.7 Reagents & Consumables- records 37
5.3.1 Equipment
Key a) Shall have documented procedure for selection,

words purchasing and management
b) Shall replace equipment as needed to ensure the
quality of results
The work a) Specification, AJK specifikasi, AJK technical, AJK

penilaian harga. Keep all documents
b) Keep Surat lantikan
c) If too old instrument; ada application / surat /
proposal dihantar kepada MOH untuk tukar?
38
5.3.1.2 Equipment acceptance testing
Key words a) Shall verify upon installation and before use

b) Each equipment shall be uniquely labelled
The a) Perform instrument evaluation/ method validation study

work
b) IQ:Installation Qualification
OQ: Operational Qualification
PQ: Performance, Process or Product Qualification
- Keep Calibration print out and sign it
-Reports must be kept for life span of equipment.
c)Make sure Testing &Commissioning is done properly
Borang KEW-PA 2 & KEW PA 3 done properly and pegawai penerima .

Document everything (refer tatacara pengurusan aset kerajaan)
www.treasury.gov.my (circulars)
39
5.3.1.3 Equipment instruction for use
Key a) Operated at all times by trained and authorized

words personnel
b) instruction on the use, manual readily available
c) Shall have procedures for safe..
The a) Show example of authorization table

work b) Picture of file next slide
c) User manuals/ operation manual must be
numbered and kept properly
40
5.3.1.4 Equipment calibration & metrological traceability
Key a) Shall have a documented procedure for the calibration of

words equipment
b) Check STR 2.3 pg 9 see calibration interval
c) Check SC; pg 18
- All reagent shall be labelled.
The work a) Show an example of calibration procedure for the

pipettes, themometer , balances (QP)
b) Daily/weekly/monthly maintenance record print and
keep
c) Done by competent personnel.
41
Key a)Documented programme of PPM

words b) Remove from service and clearly labelled
c) Check impact on previous examination results before defect was
identified.
The a) Show an example of PPM schedule

work
b) Tatacara pengurusan aset alih kerajaan (penyelenggaraan)
KEW.PA -9, KEW.PA -13 & KEW.PA -14
42
Key a)Documented programme of PPM

words b) Remove from service and clearly labelled
c) Check impact on previous examination results before defect was
identified.
The a) If machine/ petisejuk/centrifuge rosak.; label

work
b) Check QC and also if questionable result ; dont release
result
c) Keep the repair worksheet and monitored to determine
service is completed.
d) Verify and document that it is in proper working order
before being put back to service. Do QC and document
and keep in file.
43
5.3.1.7 Equipment records
Key Equipment records

words a) Identity of the equipment
The a)Prepare a file for each analyser/

work equipment
44
5.3.2.1 General
5.3.2.2 Reagents & Consumables reception and storage
5.3.2.3 Reagents & Consumables acceptance testing
5.3.2.4 Reagents & Consumables inventory management
5.3.2.5 Reagents & Consumables instructions for use
5.3.2.6 Reagents & Consumables- adverse incident reporting
5.3.2.7 Reagents & Consumables- records
The a) Prepare a procedure (QP)

work b) Make sure guideline given to main store on what are
the parameters to check on receiving of reagents.
c) Example of the QP but we didnt give to store
personnel
d) See if all these parameters in the QP
.
. 45
The work a) See if all these parameters in the QP
Is the receiving bay/receiving store personnel

receiving the reagents according to manufacturers
specification?
Eg. temperature at arrival maintained, reagents kept

in specific storage that prevent damage of reagent?
-Is there a reagent logbook for lot number and dates

of opening that reflects verification of new lots?
-Is each lot number, new shipment of reagents, or

consumable verified before use?
-Are stock counts routinely performed?

46
5.3 Laboratory equipment, reagent, & consumables continue.
The -Are storage areas set up and monitored appropriately?
work
-Is the storage area well-organized and free of clutter?
-Are there designated places labeled for all inventory

items?
-Are hazardous chemicals stored appropriately?

-Is adequate cold storage available?
-Are storage areas monitored as per prescribed storage

conditions?
-Is the ambient temperature monitored routinely?

-Is storage in direct sunlight avoided?
Is storage area clean and free of dust and pest 47
The work a) See if all these parameters in the .. Continue
-Are storage area access controlled?
-Is First Expiry and First Out (FEFO) practiced?
-Are all reagents/test kits in use(and in the stock)

currently within manufacturer assigned expiration
dates or within stability?
-Has the laboratory provided uninterrupted testing

services, with no disruptions due to stock-outs in the
last year or since last audit?
48
The work -Records for each reagent and consumable that

contribute to the performance of examination
should capture the following information:
a)Identity of the reagent or consumables?
b)Manufacturers name and batch code or lot

number?
c)Contact information for the supplier or the

manufacturer
d)Date of receiving
e)The expiry date 49

The a) See if all these parameters in the .. continue
work
f)Date of entering into service or out of service, where
applicable
g)Condition when received
h) Manufacturers instructions
i) Records that confirmed the reagents or consumables

initial acceptance for use
j) Performance records that confirm the reagents or

consumables ongoing acceptance for use.
k) If reagents prepared in-house, the date of preparation, date expiry

50
and the person prepared must be written on bottle?
5.4 Pre-Examination Processes
51
52
Explain concepts of quality and the process
for Total Quality Management (TQM)
All activities of the overall management

function that determine quality policy
objectives and responsibilities ; and
implement them by means such as
quality planning, quality control ,quality
assurance, and quality improvement
within the quality system.
5.4 Pre-Examination Procedures
ISO 15189:2007 ISO 15189:2012
5.4 Pre- 5.4 Pre-examination procedures

examination
5.4.1 General
procedures
5.4.2 Information for patients and users
5.4.3 Request form information
5.4.4 Primary sample collection & handling
5.4.4.1 General
5.4.4.2 Instructions for pre-collection activities
5.4.4.3 Instructions for collection activities
5.4.5 Sample transportation
5.4.6 Sample reception
5.4.7 Pre-examination handling, preparation and
storage
57
5.4.2 Information for patients and users
Key words Information available..
The work Prepare a user manual
58
5.4.3 Request form information
Key Request form sufficient to identify patient and authorized

words requester and the following information..
from SC 2:
Sample labeling- shall carry a minimum 2 unique identifier, type of
sample, date of sampling.
The Check your existing request form capture these info?

work Establish in your QP on Verbal request for examination-
how is the practices
59
5.4.4 Primary sample collection & handling
5.4.4.1 General
5.4.4.2 Instructions for pre-collection activities

5.4.4.3 Instructions for collection activities
Key words Shall have documented procedures for the proper collection
and handling ..
The -Can capture in user manual

wor
k - Make sure adequate privacy during sampling!
If not 24 hour lab, is there a documented method for handling
specimens?
-Are information on rejection criteria given to users.
-If critical specimen, are there special policy or procedure in
place?
-Make a quick guide .. A poster made available to ward and60
OPD
5.4.5 Sample transportation

Key words Instruction for post collection activities.
Shall have documented procedure for monitoring..
-within time frame
- Within temperature
The Can be captured in User Manual

work Can be captured in Poster
Make sure state in the QP about compromised
sample document in a book if ward/clinic being
contacted
61
5.4.6 Sample reception
5.4.7 Pre-examination handling, preparation and storage
Key words Procedures for sample reception.
The work Develop specimen receiving procedure in the lab?
-Address specimens labeled with patient unique ID,

test, date , time of collection and authorized requester?
-samples that are received from peripheral centers

accompanied by a sample delivery checklist?
- received specimens evaluated according to

acceptance/ rejection criteria? 62
5.4.6 Sample reception continue.......
Key words Procedures for sample reception.
The -specimens logged appropriately upon

work receipt in the laboratory?( date,time & name
of receiving officer)
-procedures address on how to process

urgent specimens and verbal requests?
- specimens delivered to correct

workstations in a timely manner? 63
Key words Shall have procedures & appropriate facilities for securing Time limits
for requesting additional examination.
The When samples are split, can the portions be traced back to
work the primary samples?
-If samples are to be sent to referral center, are specimens

package appropriately according to local or international
regulations and transported to referral lab within time
frames?
-Are referred specimens tracked properly using a logbook

or tracking form?
- Is there procedure available at the workstation for the

64
technician working in this area?
5.4.7 Pre-examination handling,preparation and storage ..continue....
Key words Shall have procedures & appropriate facilities for securing Time
limits for requesting additional examination.
The -Is there any special protocol for pediatric specimen?

work
- sufficient samples volume for analyser?
-degree of hemolysis, lipeamia which is acceptable?
-If samples are not analysed on the same day of receivable, are
there any procedure on storage?
-What is speed and time configured for the centrifuge?
-Are balancing of sample done prior to centrifuging?
-Check the department procedures on Core process, urgent

requests, rejection criteria and medical legal requests.
65
5.5 Examination Processes
66
5.5 Examination Procedures
ISO 15189:2007 ISO 15189:2012
5.5 Examination 5.5 Examination processes

procedures
5.5.1 Selection, verification, & validation
of examination procedures
5.5.1.2 Verification of examination
procedures
5.5.1.3 Validation of examination
procedures
5.5.1.4 Measurement uncertainty of
measured quantity values
5.5.2 Biological reference intervals or
clinical decision values
5.5.3 Documentation of examination
67
procedures
5.5.1 Selection, verification, & validation of examination

procedures
Key words Check SC pg 20
The - Each package insert , make a stamp approve for

wor use then stamp officer in charge , sign and date.
k
- Keep the most current
- Old stamp withdrawn from use and keep in the

appropriate file
- Keep a log of all the package insert 68

5.5.1 Selection, verification, & validation of examination procedures continue
5.5.1.2 Verification of examination procedures
5.5.1.3 Validation of examination procedures
5.5.1.4 Measurement uncertainty of measured quantity values
The From SC 2
work -Are standard methods being used?
-Are method verification being performed for analyser/ method?

(precision, bias, limit of detection, selectivity, repeatability &
reproducibility)
-If commercial kit being used, lab shall request manufacturer for
validation data?
-If in house method, lab must show validation done according to

relevant guideline?
69
5.5 Examination Procedures continue..
5.5.1 Selection, verification, & validation of examination procedures continue
5.5.1.2 Verification of examination procedures
5.5.1.3 Validation of examination procedures
The From SC 2
work Evaluation of method must meet the purpose; check
report accordingly.
-Report must be authorized by the responsible key

personnel for the section
-Performance specification for each procedure used in examination

relate to the intended used of that procedure.
- Check if MU being calculated for each measurement procedures? Is

lab reviewing it regularly? 70
Note 1: clearly limits MU to the analytic phase of the total

testing process.
Note 2: recommends estimation from routine SQC data over a

period of time that includes common changes or
process variables that would contribute to MU.
Note 3 : again brings in the responsibility to define goals for

how good a test should be in order to periodically
evaluate estimates of MU
71
5.5.1.4 Measurement uncertainty of measured
quantity values
The practical estimation of MU : calculate SD from SQC data,

then multiply that SD by a factor 2 to provide a conventional
95% confidence limit for a test.
The SD is known as the standard measurement uncertainty, the

factor of 2 is called the coverage factor, and the 95% limit or
interval is known as the expanded measurement uncertainty.
72
5.5.1.4 Measurement uncertainty of measured
quantity values
There is no mention of bias in this guidance.
Thus the new
ISO 15189 guidance says:
1) The lab must determine MU

2) The lab can do this with SQC data collected
over some extended period of time ,not just one
month!!!!
73
5.5.2 Biological reference intervals or clinical decision values
The Reference range- periodically reviewed or when change in

work
examination or pre-examination procedure.
-Are these changes being communicated to users/clinician?
From SC 2
Age, gender and other relevant information shall be
considered when establishing reference range.
-If laboratory intend to change procedure such that results and

interpretation could be significantly different, it shall be
explained to users.
-check for documentation on the above activity. 74

5.5.3 Documentation of examination procedures
The Are examination procedures documented in language

work understood by staff?
-Are there any quick guide/ working instruction being

displayed? If available, is proper document control steps
taken? Eg: approved to use, signed?
- The examination procedure should have(where

applicable):..
75
5.6 Ensuring quality of examination
results
76
ISO 15189:2007 ISO 15189:2012
5.6 Assuring 5.6 Ensuring quality of examination results

quality of
5.6.1 General
examination
procedures 5.6.2 Quality Control
5.6.2.2 Quality control materials
5.6.2.3 Quality control data
5.6.3 Interlaboratory comparisons
5.6.3.1 Participation
5.6.3.2 Alternative approaches
5.6.3.3 Analysis of interlaboratory comparison
samples
5.6.3.4 Evaluation of laboratory performance
5.6.4 Comparability of examination results
77
5.6.1 General
The laboratory shall ensure the quality of

examinations by performing them under defined
conditions.
Appropriate pre and post examination processes shall

be implemented (see 4.14.7, 5.4, 5.7 and 5.8)
The laboratory shall not fabricate any results.
78
5.6.2 Quality Control
5.6.2.1 General
Key You have to design a QC procedures that verify the

words attainment of the intended quality of results
What are the things you can write in your QC

procedures ?
Remember your procedure must verify the

attainment of the intended quality of results !!!!!
79

5.6.2.1 General
How are you going to define the word intended

quality?

5.6.2.1 General
Common weakness in many laboratories is lack of

definition of the requirement for quality in quantitative
terms !!!!
Now I got work for you

What is the requirement for quality in quantitative terms
?
5 minutes.
5.6.2.1 General
1) Minimum Analytical Quality Specification of inter-lab comparison: agreement among
Spanish EQAP organizers.
2) The Biologic Variation Database : Compiled by the Spanish CC Society & Dr Carmen Ricos
includes desirable,optimal and minimum Imprecision, Bias and Total Error requirement.
3) Rilibak German Guideline for Quality . Is an abbreviation meaning literally the Guideline
(Rili) of the German Federal Medical Council (BAK) (2009)
4) CLIA requirements for Analytical Quality (1992)
5) Clinical Quality Requirement that describe medically important changes in test value or
Decision intervals expressed as a percentage change at certain Decision level, also a
series of recommendations for lipid tests from National Cholesterol Education
Programmes (NCEP)
6) European Biologic Goal (1990)
7) RCPA (Royal College of Pathologist of Australasia)
8) Quality Requirement for Dogs ,Cats & Horses.
9) Biological Variation in Patient with Disease

5.6.2.1 General
Take note to the term intended quality of results
How should your lab design the QC procedure on the

basis of intended quality of results ?
How should the laboratory take into account the

precision and the bias and the quality required the
intended use of the test?
How are you going to select the control rules and the
number of measurements to verify the attainment of
intended quality?
83
5.6.2.2 Quality Control Materials
The laboratory shall use quality control materials that react to the
examining system in a manner as close as possible to patient
samples.
Matrix
base which control material is prepared
- Ideally same with specimen so they behave like
a specimen
- Controls available are human based or bovine
based.
Quality control materials shall be periodically examined with a frequency that is based
on the stability of the procedure and the risk of harm to the patient from erroneous
result
means that you have to have a plan and then design your QC
objectively based on how good your assay is
The laboratory should apply statistical control rules to make decisions on

the acceptability of analytical results and the need to reject runs and
repeat patient testing.
How many levels of QC do I need to use?

&
How many times a day should I run QC ??
For actual frequency of QC measurement, lab

should establish own frequency base on the
QC strategy
Note 1
The laboratory should choose concentration of control material, wherever possible,
especially at or near clinical decision values, which ensure the validity of decision made.
Note 2
Use of independent third party control materials should be considered, either instead of
or in addition to, any control materials supplied by the reagent or instrument
manufacturer.
Now lets look at what SC 2 says
Shall cover the analysis or analytical concentration

Shall be performed at least very day or every batch
of analysis
Its performance shall be reviewed based on
acceptance or rejection criteria and
the analytical problem shall be rectified.
The use of controls independent is preferable
Appropriate materials shall be used as calibrator
Acceptable range shall be defined for IQC
Means & SD determined using own data
Matrix matched
Extra information:
Constituents multi/ single

Storage space
Assayed & un-assayed
Appropriate & analyte level
- Cover the measure range of the analyte, normal &
pathological range
- Near medical decision level
- Chemistry 2 levels; hormone & tumor marker = 3
levels
Liquid or lyophilized stability

longer exp date (FBC & Coag)
- liquid better reproducibility no recon
Critical aspects for the correct treatment of the
control material :
Storage Temperature
Diluent
Volumetric instruments
Aliquoting
Containers
Thawed
Mixed
Waiting (when to use the recon control)
Extra information
Shelf life
Lot sequestering
Supplier can offer specific lot in quantity
required
Manufacturer service
offer to keep same lot for you
- help in storage management
The work Is the open vial stability instruction being adhered to?
-Is the temperature storage instructions being adhered
to? eg: freeze/ thawing?
-Is the fridge temperature monitored?
-Are control materials match patient sample matrix?
-What is the frequency of running quality control material for

analyzer concerned?
-How did lab check the stability of test procedure so that

erroneous result given to patient? Eg: QC Strategy, using OP Spec
chart or Sigma Metrics?
- Check the concentration of the control material? (is it near clinical

decision values?) 94
The -Is 3rd party QC being used?
work
-The IQC shall cover analytical concentration, low, N & H, +ve
& -ve control.
-Performed at least every day or every batch
-Performance shall be reviewed based on acceptance/

rejection criteria
-Special stain, positive shall be performed
-Laboratory should determine mean &SD using their own

data.
-Criteria for acceptance or rejection of a QC run established

95

5.6.2.3 Quality Control Data
Now we are in the heart of Quality Control

The laboratory shall have a procedure to prevent the release of patient results in the
event of quality control failure.
When the quality control rules are violated and indicate that examination results are
likely to contain clinical significant errors, the results shall be rejected and relevant
patient samples re-examined after the error condition has been corrected and within
specification performance is verified.
The laboratory shall also evaluate the results from patient samples that were examined
after the last successful quality control event.
Quality control data shall be reviewed at regular intervals to detect trends in

examination performance that may indicate problems in the examination system. When
such trends are noted, preventive actions shall be taken and recorded.
Note:
Statistical and non statistical techniques for process control should be used wherever
possible to continuously monitor examination system performance
Its performance shall be reviewed based on acceptance or

rejection criteria and the analytical problem shall be rectified.
A protocol for action to be taken where qc results fall

outside acceptable ranges shall be documented. Criteria for
acceptance or rejection of a QC run shall be established.
IQC results shall be recorded
Graphical presentation of numerical QC results should be
considered, to assist
the early detection trend.
Details of action taken on unacceptable results shall be
monitored
The laboratory shall have a system of long term

monitoring of IQC results to assess the method
performance against the quality specification as
stated in method validation.
A record of remedial action maintained if the
performance not meeting the quality specification.
Laboratories shall identify person(s) to be responsible

for quality control activities
How does the laboratory determine if an

analytical run provides within specification
performance ?
That depends on a properly designed QC procedure

that takes into account the intended quality of results!
Once you have proper QC design now can identify the

control rules and the number of control measurements!
What is the procedure for handling out of control runs?
What corrective action is required?
How is corrective action documented to demonstrate or

verify within Specification Performance?
What patient samples are repeated?
What patient results are reported?

5.6.2 Quality Control... Assessors area

The work -Are QC results monitored and reviewed( biases, shifts, trend & L-J
charts)?
-Is documentation of corrective action done in a timely manner

when quality control results exceed the acceptable range?
-Did the laboratory investigated and reported any out of control

incidents, due to specific reagents/consumables to manufacturer?
-Laboratory shall monitor long term IQC result to assess method

performance.
103
An example of the QC procedure
write your own

You must know that there are no QC procedure or QMS that
fits all.
104
5.6.3.1 Participation
5.6.3.3 Analysis of interlaboratory comparison samples
Key words Shall participate..

Whenever not available.
The work Is the lab participate in any External Profiency testing (PT) program?
Eg: RCPA,RIQAS,EQAS or exercise an alternative performance
assessment system when appropriate?
-Do the PT sample come from providers who are accredited or
approved?
- Did laboratory participate in PT for all tests included in the scope?
- Are PT specimens handled and tested the same as patients
specimens?
- Are all personnel involve in testing patient sample participate in
testing PT samples?
- Is cause analysis being performed for unacceptable PT results?
105
5.6.3 Interlaboratory comparisons
5.6.3.1 Participation continue..
5.6.3.3 Analysis of interlaboratory comparison samples
The Is corrective action documented for unacceptable PT

work results?
-Are the PT results being communicated with staff and
did staff participate in implementation of corrective
action?
- Is there any evidence the PT samples/ slide are
utilized for CME.
106
5.6.4 Comparability of examination results
Key words Shall be a defined means of comparing procedures,
equipment, method
The There should be a procedure .

work Where and why the correlation study needed. Define
properly.
Criteria of acceptability clearly defined.
Who going to do?
What is the frequency?
Correlation study performed . And analysed and
documented.
107
5.7 Post - examination Processes
108
5.7 Post - examination processes
ISO 15189:2007 ISO 15189:2012
5.7 Post- 5.7 Post examination processes

examinatio
5.7. 1 Review of results
n processes
5.7.2 Storage, retention & disposal of
clinical samples
109
5.7. 1 Review of results
Key words Shall have documented procedure
The Are there any authorized personnel

work systematically review the result?
- Are there any criteria documented for
automatic review of results?
110
5.7.2 Storage, retention & disposal of clinical samples
Key Shall have documented procedure

words
The work
Are the retention time of sample
documented? And in accordance
to national guideline? (show
Retention Time Guideline)
111
5.7.2 Storage, retention & disposal of clinical samples
Key words Shall have documented procedure
The -Check how specimens are being stored after

work analysis?
-Are there any procedure in place if specimens
are being re-analysed on request by
clinicians?eg: the timeframe of reanalysis
allowed? The temperature of storage
monitored?
- Is room temperature monitored if samples kept
at room temperature?
- Are specimens disposed off in a safe manner?
- Are disposal being recorded? Eg: person who 112
5.8 Reporting of Results
5.9 Release of Results
113
5.8 Reporting of results
5.9 Release of results
ISO 15189:2007 ISO 15189:2012
5.8 Reporting 5.8 Reporting of results

of results
5.8. 1 General
5.8.2 Report attributes
5.8.3 Report content
5.9 Release of 5.9 Release of results
results
5.9.1 General
5.9.2 Automated selection and reporting of
results
5.9.3 Revised Reports
114
115
116
5.8 Reporting of results
5.8. 1 General
5.8.2 Report attributes
5.8.3 Report content
Key words Shall be reported accurately, clearly, .
Shall have procedure correctness
SC 2 electronic validation- person authorizing the use of particular
algorithm for automatic release shall be traceable from the issued
report/result
SC 2- Electronic transmission of result check record of checking
accuracy of transmission
The work Example of report .

Original & corrected result if relevant
Signature or authorization of person checking /releasing the report;
where possible
Prepare a procedure on checking of transmission of results..
Have a file.. 117
5.8 Reporting of results 5.9 Release of results

5.9.1 General
5.9.2 Automated selection and reporting of results
Key shall establish procedure for the release.

words
The work Report shall indicate the quality of primary sample was unsuitable for
examination/ could have compromised the result.
Retention of report result and ability of prompt retrieval
Are procedures for immediate notification of results fall within

established critical value?
Critical value properties/criteria?

Result transmitted as interim report, final report forwarded to requester?
118

5.9.1 General
5.9.2 Automated selection and reporting of results
Key words shall establish procedure for the release.
The work Check Record of response taken for critical result-date, time, lab
staff, person notified and result of examination?
Established TAT-reflecting the clinical need?
-Lab monitor the TAT & remedial action recorded
- Lab notify if result delayed and could compromised patients care

119
The Are procedures of release of result available?eg: who and to whom.
work
Are procedures on reporting verbal result available? -Check for protocol of

how users record the verbal result?
SC 2 Integrity of data transfer rest with the lab
Are policy & procedure regarding alteration of report available?
Record show time, date name of person responsible for change?
Original entries remain legible when alteration made?
SC 2 Issue of complete new result or report shall be uniquely identified and

contain a reference to the original that it replace?
Result that have been available for clinical decision making & revised shall
be retained in subsequent cumulative report?
120
121
122
123
124
125
126
127
128
5.10 Laboratory Information
Management
129
5.10 Laboratory Information Management
ISO 15189:2007 ISO 15189:2012
Annex Recommendation 5.10 Laboratory Information Management

B for laboratory
5.10.1 General
information
systems (LIS) 5.10.2 Authorities and Responsibilities
5.10.3 Information System Management
Key shall have a documented procedure

words
The work Example of procedure
130
The -Undertaking of confidentiality

work contract that must be signed by
supplier.
-The lab shall define authorities and
responsibilities of all personnel
who use the system.
Must have a list of personnel name

and authorities:
131
The a) Access patient data and information

work b) Enter patient data and examination
results
c) Change patient data or examination
results
d) Authorize the release of examination
results and reports
132
133
134
Make sure you include the procedure what to do if the

LIS breakdown especially on how to release result!!
135
136
Quality must be Measured in order to be Managed.
137
Evidence requirements
Where does it say what you do?
Why is it done that way?
Do staff know what should be done and why?
Where is this implemented?
Where is the evidence that this is implemented?
Is the evidence objective?
What does the evidence tell you?
Does it work?
138
ACKNOWLEDGEMENT
Department of Standard Malaysia
Also Cik Norehan for making copies of the
lecture notes to you.
Staffs in HPP who enable me to learn from
experience.
Special thanks to Dr Westgards, Dr Jamilah, Dr
Soo, DSM assessors who are my gurus
139

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ISO 15189 : 2012

1. Read the key words in each clause

2. Dissect, decode and interpret of each

3. The practical what/how to do in lab

These are statements within the standard that

In some situations, Terms such as TO THE EXTENT

A single document may address the

The ISO 15189 identifies what needs to be done,

As busy laboratory scientists, it is difficult to see

Heres where the Demings cycle provides a basic structure

Act Management Plan

5.1 Personnel 5.1 Personnel

Key words documented procedure for personnel

The work Check in the QM (dr raja elinas lecture),

Key words -document personnel qualifications for each position

- Personnel making judgments have the applicable

The work check the STR 2.4 and SC (page 8)

Key Job descriptions that describe

The work Fail Meja, Carta organisasi

Key words a program to introduce new staff to the

The work Kursus orientasi , keep the

-Department should have a QP on training Example of QP

Key words -Assess the competence of each person to perform assigned

The work - Develop a competency assessment module based on the

Note: Staff performing reviews should receive appropriate

No Elements Characteristics Requirements

Key Shall be periodically reviewed. Personnel shall take part in

Records of the relevant educational and professional qualifications, training and

These records shall be readily available to relevant personnel and shall

a) Educational & professional qualifications;

ISO 15189:2007 ISO 15189:2012

5.2 Accommodation 5.2 Accommodation and environmental

Key Shall have space allocated for the performance

The work Emphasis on adequacy of space to ensure safety

Sample collection facilities and POCT are also

Key words - Controlled access

Example: operation of emergency release, intercom and alarm systems

The Example of Temperature monitoring of fridge ,

Key words -washroom

Key Patient sample collection facilities- privacy, disabilities

The Blood bank bleeding area- first aid kit

Key Work area clean and well maintained

The CHRA must be done in drug lab

ISO 15189:2007 ISO 15189:2012

Key a) Shall have documented procedure for selection,

The work a) Specification, AJK specifikasi, AJK technical, AJK

Key words a) Shall verify upon installation and before use

The a) Perform instrument evaluation/ method validation study

c)Make sure Testing &Commissioning is done properly

Borang KEW-PA 2 & KEW PA 3 done properly and pegawai penerima .

5.3.1.3 Equipment instruction for use

Key a) Operated at all times by trained and authorized

The a) Show example of authorization table

5.3.1.4 Equipment calibration & metrological traceability

Key a) Shall have a documented procedure for the calibration of

The work a) Show an example of calibration procedure for the

Key a)Documented programme of PPM

The a) Show an example of PPM schedule

Key a)Documented programme of PPM

The a) If machine/ petisejuk/centrifuge rosak.; label

5.3.1.7 Equipment records

Key Equipment records

The a)Prepare a file for each analyser/