1. นางสุขใจ ผลอำไพสถิตย์ 30 กรกฎาคม 2557
ISO 15189:2012 Medical laboratories-Requirements for Quality and competence
นางสุขใจ ผลอำไพสถิตย์
30 กรกฎาคม 2557

2. เตรียมความพร้อมในการขอรับรอง ISO 15189:2012 ปี 2558

3. Improved layout & listing of subclauses
Reference: Gap analysis of ISO 15189:2012 and
version 2007 (NATA); issued 2013
Summary of changes
Improved layout & listing of subclauses
More logical ordering of subclauses
Two new normative section (5.9 and 5.10)
-5.9 Release of results ( 5.8 split into 5.8 & 5.9)
-5.10 Lab Information Management (New section)
Additional detail, no change of intent to the requirements

4. Summary of changes (2)
Title : Medical laboratories-Requirements for quality and competence
Definitions
- 19 (2007) and 27 (2012) definitions
- (7) removed: accuracy to measurement , uncertainty etc.
- Additional 15 definitions: alert interval, nonconformity, process etc.

5. ISO 15189: 2003, 2007, 2012
ISO 15189:2007
ข้อกำหนด
ข้อกำหนด
ISO 15189:2012
ข้อกำหนด
ข้อกำหนด

6. 5.1 Personnel

7. Personnel (Significant editorial)
5.1
Personnel (Significant editorial)
Divide personnel requirements into sections
5.1.1 General
5.1.2 Personnel qualification
5.1.3 Job description
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
Responsibilities of lab director moved out

8. Documented procedure: personnel management Personnel qualifications
5.1
Personnel
5.1.1
new
5.1.2
5.1.4
Documented procedure: personnel management
Personnel qualifications
ผู้บริหารระบุคุณสมบัติบุคลากรในทุกตำแหน่งเป็นลายลักษณ์ฯ
Personnel qualification: appropriate education, training, experience and demonstrated skills
Personnel introduction to the org environment
Lab has a programme to introduce new staff : Department or area in which the person will work, terms and condition of employment, staff facilities, health and safety requirement, occupational health service.

9. Lab provide training for all personnel Quality Management System
5.1
Personnel
5.1.5
Amended/new
Training
Lab provide training for all personnel
Quality Management System
Assigned work processes and procedures
Application of LIM
Health and safety, prevention or containment of effect of adverse incident
Ethics (จริยธรรม)
Confidentiality of patient information
Personnel are undergoing training supervised at all time
Effectiveness of training programme periodically reviewed

10. 5.1 Personnel 5.1.6 Competence assessment
Sig editorial
Competence assessment
Assess the competence of each personnel to perform assigned task following training
Reassessment at regular intervals
Retraining occur when necessary
Competence of lab staff can be assessed by any combination or all following approaches * Note 1
Direct observation of routine work processes and procedure, safety practice
Direct ob of equipment maintenance and function checks
Monitoring the recording and reporting the exam results
Review of work record
Assessment of problem solving skill

11. 5.1 Personnel 5.1.7 5.1.8 Review of staff performance
new
5.1.8
Amended/new
Review of staff performance
Reviews of staff performance to maintain or improve the quality of service
Continuing education and professional development
A continuing education programme available to personnel who participate in managerial and technical process.
Personnel must take part in continuing education
Effectiveness of the edu pro reviewed periodically
Personnel take part in regular professional development

12. 5.1 Personnel 5.1.9 Personnel record
amended
Personnel record
Record of all personnel maintained
Record readily available and include
Copy of certification when applicable
Introduction of new staff to the lab environment (Orientation)
Reviews of staff performance
Reports of accidents, exposure to occupational hazards
Training in current job tasks
Competency assessment
Records of continuing edu and achievements
Immunization status JD
Previous work experience
Records are not stored in the lab

13. 5.3 Laboratory equipment
Lab equipment , reagent , consumables

14. Lab equip, reagent, consumables Note
5.3
Lab equip, reagent, consumables
Note
Lab equipment: hardware and software of instruments, measuring systems, lab information system (LIS)
Reagent: reference materials, calibrators & quality control materials
Consumables: culture media, pipette tips, slide etc

15. Lab equip, reagent, consumables
5.3
Lab equip, reagent, consumables
Sig editorial
Lab equip
general
acceptance testing
instruction for use
cal and metrological traceability
equipment maintenance and repair
adverse incident reporting
records

16. Lab equip, reagent, consumables
5.3
Lab equip, reagent, consumables
Sig editorial
reagent and consumables
general
acceptance testing
instruction for use
cal and metrological traceability
equipment maintenance and repair
adverse incident reporting
records

17. Lab equip, reagent, consumables 5.3.1.1
General
Procedure for selection, purchasing and management of equipment
Lab replace equipment as needed to ensure the quality of exam results
Equipment instructions for use
lab has procedures for safe handling, transport, storage and use of equip to prevent its contamination

18. Lab equip, reagent, consumables 5.3.1.4 new
Equipment calibration and metrological traceability
Procedure for calibration of equip that direct of indirect affects exam results include:
Metrological traceability must be to a reference material
Equipment records
 Performance records include copies of report/certificates of all calibrations and/or verifications.

19. Lab equip, reagent, consumables 5.3.2 5.3.2.1 new 5.3.2.2
Reagents, consumables
Procedure for reception, storage, acceptance testing, inventory management of reagent and consumable
Receiving location have adequate storage and handling capacities to prevent damage/deterioration and this must be verified, where lab is not receiving facility
Inventory control system segregate uninspected & unacceptable reagents and consumables from the accepted ones
Instruction for the use of reagents & consum. available
inventory management
Reagent records

20. Lab equip, reagent, consumables 5.3.2.6
amended
Reagents, consumables- adverse incident reporting
Incident that attributed directly to specific reagents or consum. Investigated and reported to manufacturer and authorities
Reagent records:
-Identity
-manufacturer’s name,
-expire date, date material taken out of service
-condition received (acceptable/ damaged)
-manufacturer’s instruction
-initial acceptance for use
-performance records that confirm for ongoing acceptance for use
-where reagent prepared in-house, records must include person (s) undertake the preparation & date

21. 5.4 Pre-examination procedure Pre-examination processes

22. 5.4
Pre-exam processes
Sig editorial
5.4.1 general
5.4.2 info for patients and users
5.4.3 request form info
5.4.4 primary sample collection and handling
5.4.5 Sample transportation
5.4.6 Sample reception
5.4.7 Pre-exam handling, preparation and storage

23. Procedure for pre-exam (คู่มือเก็บตัวอย่าง)
5.4
Pre-exam processes
5.4.1
5.4.2
Amended
Procedure for pre-exam (คู่มือเก็บตัวอย่าง)
information for patients and users
location, type of clinical services, Opening hours of lab
Exam offered, sample volume, special precaution, TAT,
biological reference intervals,clinical decision values
Instruction for completion request form, collection
instruction for transportation, special handling needs
Criteria for accepting, rejecting sample
a list of factors known to affect the performance of exam or the interpretation of the results
lab’s policy on protection of personal information
Lab ‘s complaint procedure

24. 5.4 Pre-exam processes 5. 4.3 amended Request form info
clinically relevant info about patient for exam performance and result interpretation purpose
Family history, travel and exposure history
date and time of sample collection, receipt
lab cooperate with users in clarifying the user’s request

25. 5.4 Pre-exam pro Pre-exam processes 5.4.4.1 new 5.4.4.3d - Genneral
where users requires deviations from doc collection procedure, these must be recorded in exam results and be communicated to the appropriate personnel
-Instruction for collection activities
info regarding sample containers, additives etc must be communicated to those staff, in situation where collection performed by clinical staff.

26. 5.5 Examination procedure Examination processes

27. Examination processes 5.5.1.1 amend
Amend/new
Selection, verification& validation procedures
-preferred procedure: in vitro medical devices, published in established/authoritative textbook, peer-reviewed texts or journals or international consensus stds or guidelines
- The identity of persons performing recorded
Verification of exam procedure
validated procedure must be verified before use
info to be obtained from the manufacturer / method developer regarding the performance characteristics of the procedure
procedure of verification, the verification must confirm that the performance claim met and reviewed by appropriate staff

28. Examination processes 5.5.1.3 amend
Validation of exam procedures
For non-std methods, developed methods , std method used outside their intended scope , validated method modified
Performance characteristics: measurement trueness, accuracy, precision, repeatability, intermediate precision, Uncertainty, analytical specificity, sensitivity, detection limit, quantitation limit, diagnostic spec &sensitivity.

29. Examination processes 5.5.1.4
Amend/new
5.5.2
amend
amend/new
Measurement uncertainty of measured quantity values
determine the uncertainty of results with the quantity values
Where exam include a measurement step but do not report a quantity value, lab should calculate the uncertainty of measurement step in assessing the reliability of the procedure or influence the reported
result.
Biological reference intervals or clinical decision values
define, documented and communicated to users
Documentation of exam procedures
include: patient prep, type of containers& additives
Principle of procedure for cal results ; Uncertainty,
Envi & safety control, biological reference control etc

30. 5.6 Assuring quality of examination procedures
Ensuring quality of examination results

31. Ensuring quality of examination results
5.6
Ensuring quality of examination results
Sig editorial
general
5.6.2 quality control
interlab comparison

32. Ensuring quality of examination results
5.6
Ensuring quality of examination results
5.6.1
new
performing exam under defined conditions
appropriate pre and post –exam are implement
Result are not fabricated
Quality control materials
react in a manner as close to patient samples
periodically examined with a frequency based on stability of procedure and the risk of harm to the patient from erroneous result
Quality control data
procedure to prevent results being released in a QC failure
When QC rules are violated, results rejected and re-exam after errors
QC data regularly reviewed to detect trends with preventive action , recorded

33. Ensuring quality of examination results
5.6
Ensuring quality of examination results
5.6.3
new
editorial
Inter laboratory comparisons
Participation
participate in an inter lab comparisons ( such as EQA,PT programme)
Procedure for inter lab comparison participation: responsibility & instruction for participation, any performance criteria differed from the prog
Alternative approaches
certified ref materials,
sample previously examined,
material from cell repositories,
exchange of samples with other labs
Control materials that are tested daily in inter lab comparison prog

34. Ensuring quality of examination results
5.6
Ensuring quality of examination results
new
new
Analysis of inter lab comparison samples
Integrate the samples into routine workflow
Evaluation of lab performance
Performance in interlab comparison reviewed and discussed with relevant staff
when predetermined performance criteria are not fulfilled ,implement corrective action

35. 5.7 Post-examination procedures Post- examination processes

36. Post-examination processes
5.7
Post-examination processes
5.7.1
Amend/new
Review of results
SOP include ensuring that personnel review the results of exam before release and evaluate against internal quality control
involves automatic reporting review criteria to be documented

37. 5.9 Release of results

38. 5.9
Release of results
5.9.2
New
Automated selection and reporting of results
requirement and criteria for automated results

39. 5.10 Laboratory Information Management

40. 5.10
LIM
5.10.1
5.10.2
5.10.3
Information system: computerized and non-computerized
Authorities and responsibilities
define authorities and respon of all personnel
Who use the system: acess pat data&info, examination results, change data&results, release the results
LIM :collection, processing, recording etc
validated and verified, protected, safeguard