These slides are meant for awareness training for the institutions which are seeking accreditation in ISO 15189. Although the current standard is the 4th version, some information in these slides might be useful in assisting the laboratory in preparing for the accreditation since the newest version is less prescriptive.

1.  5.4 PRE- EXAMINATION PROCESSES
 5.5 EXAMINATION PROCESSES
 5.6 ENSURING QUALITY OF EXAMINATION RESULTS
 5.7 POST-EXAMINATION PROCESS
 5.8 REPORTING OF RESULTS
 5.9 RELEASE OF RESULTS
 5.10 LABORATORY INFORMATION MANAGEMENT

2. 2
Technical
Requirements
‘the how to’

3. 3
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

4. 4
Normative statements
These are statements within the standard that
are REQUIRED. They use the word “SHALL”
which is understood to mean “MUST”.

5. 5
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.

7. 7
Technical Requirements
5.4 Pre-Examination Processes

8. 8

9. ISO 15189:2012
5.4 Pre-examination procedures
5.4.1 General
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
9

10. 10
The
work
Prepare a user
manual
Key
words
Information available…..
5.4.2 Information for patients and users

11.  http://appmkakb.moh.gov.my/bukupanduan/Buku_Panduan_Perkhidmatan_MKAKB.pdf
Coming soon!
Edisi ke-2 2020

12. The Work
i. Check our existing request form capture
these info?
ii. Establish in your QP on Verbal request for
examination- how is the practices
12
Key
words
Request form sufficient to identify patient and
authorized
requester and the following information…..
from SC 2:
Sample labeling- shall carry a minimum 2 unique
identifier, type of sample, date of sampling.
5.4.3 Request form information

14. The Work
i. Can capture in user manual
ii. Make sure adequate privacy during sampling!
iii. If not 24 hour lab, is there a documented method for handling
specimens?
iv. Are informations 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 clinics/ ward
Key words Shall have documented procedures for the proper
collection and handling …..
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

15. Rejection criterias:

16. 61
5.4.5 Sample transportation
Key
words
Instruction for post collection activities….
http://appmkakb.moh.gov.my/bukupanduan/Buku_Pandua
n_Perkhidmatan_MKAKB.pdf
(pg 22 onwards)
Shall have documented procedure for monitoring…..
- within time frame
- within temperature
The
Work
i. Can be captured in User Manual (alternatively, poster etc)
ii. Make sure state in the QP about compromised
sample…
iii. Document if ward/clinic being contacted

17. The Work
i. Develop specimen receiving procedure in the lab?
Ref: MKAKB/BP/QP-15 Management of Specimen at Disease Sector
ii. Address specimens labeled with patient unique ID,
test, date , time of collection and authorized requester?
iii. samples that are received from peripheral
centers accompanied by a sample delivery
checklist?
iv. received specimens evaluated according to
acceptance/ rejection criteria?
5.4.6 Sample reception
5.4.7 Pre-examination handling, preparation and storage
Key words Procedures for sample reception….

18. http://appmkakb.moh.gov.my/iso/

19. 63
5.4.6 Sample reception continue.......
5.4.7 Pre-examination handling, preparation and
storage
Key
words
Procedures for sample reception….
The
work
i. specimens are logged appropriately upon receipt in
the laboratory? (date, time & name of receiving
officer)
ii. procedures address on how to process
‘urgent” specimens and verbal requests?
iii. specimens delivered to correct
workstations in a timely manner?

21. The
work
i. When samples are split, can the portions be traced back to
the primary samples?
ii. If samples are to be sent to referral center, are
specimens package appropriately according to local or
international regulations?
SOP for Transport of Biological Specimens in Malaysia 1st Ed. 2012
iii. and transported to referral lab within appropriate time
frames?
iv. Are referred specimens tracked properly using a
logbook or tracking form?
v. Is there procedure available at the workstation for the
technician working in this area?
5.4.7 Pre-examination handling, preparation and storage
Key words …shall have procedures & appropriate facilities for securing
Time limits for requesting additional examination….

22. 5.4.7 Pre-examination handling,preparation and storage ..continue....
22
Key words Shall have procedures & appropriate facilities for securing
Time limits for requesting additional examination….
The
work
i. Is there any special protocol for pediatric specimen?
ii. sufficient samples volume for analyser?
iii. degree of hemolysis, lipeamia which is acceptable
iv. If samples are not analysed on the same day of
receipt, are there any procedure on storage?
v. What is speed and time configured for the centrifuge?
Source?
vi. Are balancing of sample done prior to centrifuging?
vii. Check the department procedures on Core
process, urgent requests, rejection criteria and
medical legal requests.

23. 23
Technical Requirements
5.5 Examination Processes

24. 7
6
ISO 15189:2012
5.5 Examination processes
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 procedures

25. The
work
i. Each package insert, make a stamp “approve for
use” then stamp
officer in charge, sign and date. Keep the most current
ii. Old – stamp “withdrawn from use/ obsolete” and keep in
the appropriate file
iii. Keep a log of all the package insert.
5.5.1 Selection, verification, & validation of
examination procedures
Key words Check SC pg 20

26. 26
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
work
From SC 2
-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 method validation was
done according to relevant guideline.

27. What are they ?
• Method validation & verification provides objective
evidence that a test method is fit for purpose,
i.e. that the particular requirements for a specific intended
use are fulfilled.
• The term ‘method’ includes kits, individual reagents,
instruments, platforms and software.
• Method Validation : in-house and modified standard
methods
• Method Verification : standard methods

28. 28
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
work
From SC 2
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?

31. 31
5.5.1.4 Measurement uncertainty of measured quantity
values
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

32. 32
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.
5.5.1.4 Measurement uncertainty of measured
quantity values

33. 33
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!!!!
5.5.1.4 Measurement uncertainty of measured
quantity values

34. The
work
i. Reference range- periodically reviewed or when change in
examination or pre-examination procedure.
ii. Are these changes being communicated to
users/clinician? From SC 2
iii. Age, gender and other relevant information shall be
considered when establishing reference range.
iv. If laboratory intend to change procedure such that results
and interpretation could be significantly different, it shall be
explained to users.
v. check for documentation on the above activity.
5.5.2 Biological reference intervals or
clinical decision values

35.  Biological reference intervals = decision values = reference
range = normal range = normal values
“ julat nilai di mana kita boleh interpret nombor yang terhasil
secara objektif untuk membuat keputusan klinikal”
Berdasarkan kajian perbandingan dalam sesuatu populasi,
umur dan jantina

36. 36
5.5.3 Documentation of examination
procedures
The
work
i. Are examination procedures documented in
language understood by staff?
ii. Are there any quick guide/ working instruction
being displayed? If available, is it correspond to the
documented procedure?
iii. Are proper document control steps taken? Eg:
approved to use, signed?
iii. The examination procedure should have
(where applicable):…..

37. Mana 5.6 Ensuring quality of
Examination Result?
Slot En Farid Ceramah 7 @ 1615hrs

38. 38
Technical Requirements
5.7 Post - examination Processes

39. 39
ISO 15189:2012
5.7 Post –examination processes
5.7. 1 Review of results
5.7.2 Storage, retention & disposal of clinical
samples

40. 40
Key words shall have documented procedure
The
work
i. Are there any authorized personnel
systematically review the result?
= evaluate against IQC, available clinical information &
previous results.
ii. Are there any criteria documented for automatic
review of results? = auto validation for numerical
results
5.7. 1 Review of results

41. 41
Key
words
shall have documented procedure for
identification, collection, retention, indexing,
access, storage, maintenance and safe
disposal
The work
i. Are the retention time of samples documented?
ii. And in accordance to national guideline? (show
Retention Time Guideline)
5.7.2 Storage, retention & disposal of clinical
samples

44. The work
i. Check how specimens are being stored
after analysis? (uncapped post-a sample issues)
ii. Are there any procedure in place if specimens
are being re-analysed on request by clinicians?
eg: the timeframe of reanalysis
iii. The temperature of storage monitored?
iv. Is room temperature monitored if samples kept at
room temperature?
v. Are specimens disposed off in a safe manner?
vi. Are disposal being recorded? Name, date & time
(histopathology & cytology)
Key words Shall have documented procedure
5.7.2 Storage, retention & disposal of clinical
samples

45. 45
Technical Requirements
5.8 Reporting of Results

46. 46
ISO 15189:2012
5.8 Reporting of results
5.8. 1 General
5.8.2 Report attributes
5.8.3 Report content

47. 47

48. 7
The work
i. Check our existing report (view from client module)
ii. Original & corrected result – if relevant
iii. Signature or authorization of person checking /releasing the
report; where possible.
iv. Prepare a procedure on checking of transmission of results..
(Have a file for reference/ audit)
5.8. 1 General
Key words i. …shall be reported accurately, clearly, unambiguously…
ii.…shall have procedure to ensure correctness of
transcription of laboratory results.
iii. …shall include the information necessary for the
interpretation of the examination results.
iv. …shall have a process for notifying the requester when
examination is delayed…

49. 7
The work
i. Comments/ interpretative comments can
be viewed in whole
ii. Critical result – remarked on report?
5.8.2 Report attributes
Key words i. …shall ensure:
a) Comments on sample quality
b) Comments regarding sample suitability
c) Critical results
d) Interpretative comment on results
In the final report effectively communicate laboratory results and
meet users’ need.

50. 7
The work
i. Check our existing report whether fulfil the need of this clause
5.8.3 Report content
Key words i. …shall include 16 items:
Examination procedure (test name), identification of lab (lab’s
name), identification of all examination (test list), pt ID, pt location,
requester id, requester contact details, date & time of primary
sample collection, measurement procedure, examination results (in
SI unit), ref. interval, interpretation, other comments, id of person
reviewing results & auhorizing the release, report date and time,
page no. of total no. of pages (eg: ms 1 dari 3)

52. 52
Technical Requirements
5.9 Release of Results

53. 53
ISO 15189:2012
5.9 Release of results
5.9.1 General
5.9.2 Automated selection and reporting of results
5.9.3 Revised Reports

54. The work
i. Report shall indicate the quality of primary sample was unsuitable
for examination/ could have compromised the result. (biasa
dimasukkan pd ruangan komen makmal)
ii. Notify (kriteria) and record (butiran) for “alert’ or “critical” intervals
Check Record of response taken for critical result-date, time,lab staff, person notified and result ofexamination?
Established TAT-reflecting the clinicalneed?
-Lab monitor the TAT& remedial action recorded
- Lab notify if result delayed and could compromised patient’scare
iii. Results are legible, no transcription error, reported to authorized
person to receive and use info.
iv. Result transmitted as interim report, final report forwarded to
requester? (histo/haemato)
v. Results only reach authorized recipients. Orally provided results
has to be recorded, followed by written one)
5.9 Release of results
5.9.1 General
Key
words
shall establish procedure for the release….

55. 119
5.9 Release of results
5.9.2 Automated selection and reporting of results
Key
words
…shall establish documented procedure….
The work
SIMKA or iLab have to:
i. Understood by staff
ii. Function properly before use & verified after system
changes
iii. Process indicationg HIL
iv. Analytical warning messages (too hi too low exceed linearity etc)
v. Identifiable at the time of review before release
vi. Rapid suspension process

56. 56

57. 57

58. The
work
i. Identifiable- remark ‘revision’, reference to date & pt ID
in original report.
ii. User is made aware of the revision
iii. Time, date, name of person
iv. Original report entries remain in the record
SIMKA/ iLab cannot capture amendments, retain a hardcopy
5.9 Release of results
5.9.3 Revised reports
Key
words
…shall be written instructions regarding the
revision….

59. 59

60. 60

61. 61

62. 62
Technical Requirements
5.10 Laboratory Information
Management

63. 63
ISO 15189:2012
5.10 Laboratory Information Management
5.10.1 General
5.10.2 Authorities and Responsibilities
5.10.3 Information System Management

64. 64
The
work
i. Understand that information system includes the mx of data
and info in both computer and non-computerized system.
ii. Go through QP-19: Management of LIS
Key
words
i. …shall have access to data and info
ii. …shall documented procedure to ensure
confidentiality of pt info
Laboratory Information Management
5.10.1 General

65. 65
The
work
i. Define the authorities and responsibilities of all personnel
who:
a) Access patient data and information
b) Enter patient data and examination results
c) Change patient data or examination results
d) Authorize the release of examination results and
reports
Laboratory Information Management
5.10.2 Authorities and responsibilities
Key
words
i. …shall ensure the authorities and
responsibilities for the mx of the IS are defined

66. 66
The
work
i. Validated by supplier & verified for functioning before
introduction (go live) – ensure proper functioning between
other systems eg: OTMS, CenSISS
ii. Day-to-day functioning is ocumented
iii. No unauthorized access
iv. Safeguard against tampering or loss
v. Operated as per supplier spec.
vi. Maintained – ensure data & info integrity, include the
recording of system failures, immediate and corrective
actions
vii. In compliance with National/ International data protection
requirement
Laboratory Information Management
5.10.3 Information System Management

67. 67
Make sure you include the procedure what to do if the
LIS breakdown especially on how to release result!!

68. 68
• Standards Malaysia
• www.accreditation.gov.my