ISO 15189:2012
Medical laboratoriesRequirements for Quality and
competence
นางสุขใจ ผลอาไพสถิตย ์
30 กรกฎาคม 2557
•เตรียมความพร ้อมในการขอร ับรอง
ISO 15189:2012
ปี 2558
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.
ISO 15189: 2003, 2007, 2012
• ISO
15189:2007
• ISO
15189:2012
• ข้อกาหนด 4.14.15
• ข้อกาหนด 5.15.8
• ข้อกาหนด 4.14.15
• ข้อกาหนด 5.15.10
5.1 Personnel
(Significant editorial)
•Divide personnel requirements into sections
5.1.1- 5.1.9
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
5.1
Personnel
5.1.1 Documented procedure: personnel management
new
5.1.2 Personnel qualifications
new
ผู้บริ หารระบุคณ
ุ สมบัติบคุ ลากรในทุกตาแหน่งเป็ นลายลักษณ์ฯ
Personnel qualification: appropriate education,
training, experience and demonstrated skills
5.1.4
new
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.
5.1
Personnel
5.1.5
Amended
/new
•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
5.1
Personnel
5.1.6
• Assess the competence of each personnel to perform
Sig
editorial 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
5.1
Personnel
5.1.7 Review of staff performance
new
Reviews of staff performance to maintain or improve the
quality of service
5.1.8 Continuing education and professional development
Amended
/new
•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
5.1
5.1.9
amend
ed
Personnel
• Record of all personnel maintained
• Record readily available and include
1. Copy of certification when applicable
2. Introduction of new staff to the lab environment
(Orientation)
3. Reviews of staff performance
4. Reports of accidents, exposure to occupational hazards
5. Training in current job tasks
6. Competency assessment
7. Records of continuing edu and achievements
8. Immunization status
9. JD
10. Previous work experience
• Records are not stored in the lab
Lab equipment , reagent , consumables
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
5.3
Lab equip, reagent, consumables
Sig editorial
5.3.1.1 general
5.3.1.2 acceptance testing
5.3.1.3 instruction for use
5.3.1.4 cal and metrological traceability
5.3.1.5 equipment maintenance and repair
5.3.1.6 adverse incident reporting
5.3.1.7 records
5.3
Lab equip, reagent, consumables
Sig editorial
5.3.1.1 general
5.3.1.2 acceptance testing
5.3.1.3 instruction for use
5.3.1.4 cal and metrological traceability
5.3.1.5 equipment maintenance and repair
5.3.1.6 adverse incident reporting
5.3.1.7 records
5.3
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
5.3.1.3
Equipment instructions for use
• lab has procedures for safe handling, transport,
storage and use of equip to prevent its contamination
5.3
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
5.3.1.7
Equipment records
 Performance records include copies of
report/certificates of all calibrations and/or
verifications.
5.3
Lab equip, reagent, consumables
5.3.2
5.3.2.1
new
5.3.2.2
new
Reagents, consumables
•Procedure for reception, storage, acceptance testing,
inventory management of reagent and consumable
5.3.2.4
new
5.3.2.5
new
• 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
5.3
Lab equip, reagent, consumables
5.3.2.6
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
5.3.2.7
amended
Pre-examination processes
5.4
Pre-exam processes
Sig
5.4.1 general
editorial 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
5.4
5.4.1
5.4.2
Amended
Pre-exam processes
Procedure for pre-exam (คูม่ ือเก็บตัวอย่าง)
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
5.4
Pre-exam processes
5. 4.3
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
amended
5.4 Pre-exam pro
Pre-exam processes
5.4.4.1
new
5.4.4.3d
new
- 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.
Examination processes
5.5
Examination processes
5.5.1.1
amend
• 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
5.5.1.2 • Verification of exam procedure
Amend/ validated procedure must be verified before use
info to be obtained from the manufacturer / method
new
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
5.5
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.
5.5
Examination processes
5.5.1.4
Measurement uncertainty of measured
quantity values
determine the uncertainty of results with the
quantity values
Amend/new
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
5.5.2
define, documented and communicated to users
amend
Documentation of exam procedures
include: patient prep, type of containers& additives
5. 5.3
Principle of procedure for cal results ; Uncertainty,
amend/new
Envi & safety control, biological reference control etc
Ensuring quality of examination results
5.6
Ensuring quality of examination results
5.6.1 general
Sig
editorial 5.6.2 quality control
5.6.3 interlab comparison
5.6
5.6.1
new
5.6.2.2
new
5.6.2.3
new
Ensuring quality of examination results
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 reexam after errors
•QC data regularly reviewed to detect trends with
preventive action , recorded
5.6
5.6.3
5.6.3.1
new
Ensuring quality of examination results
Inter laboratory comparisons
•Participation
participate in an inter lab comparisons ( such as
EQA,PT programme)
5.6.3.2
editorial
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
5.6
5.6.3.3
new
5.6.3.4
new
Ensuring quality of examination results
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
Post- examination processes
5.7
Post-examination processes
5.7.1
Review of results
Amend/ SOP include ensuring that personnel review
new
the results of exam before release and evaluate
against internal quality control
involves automatic reporting review criteria
to be documented
5.9
5.9.2
New
Release of results
Automated selection and reporting of results
requirement and criteria for automated
results
5.10
5.10.1
5.10.2
5.10.3
LIM
Information system: computerized and noncomputerized
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