ISO 15189:2012Medical laboratories-Requirements for

Quality and competence

นางสุขใจ ผลอําไพสถิตย30 กรกฎาคม 2557

•เตรียมความพรอมในการขอรับรอง ISO 15189:2012ป 2558

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

Reference: Gap analysis of ISO 15189:2012 andversion 2007 (NATA); issued 2013

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 15189:2007• ขอกําหนด 4.1-4.15• ขอกําหนด 5.1-5.8

• ISO 15189:2012• ขอกําหนด 4.1-4.15• ขอกําหนด 5.1-5.10

ISO 15189: 2003, 2007, 2012

5.1 Personnel (Significant editorial)

•Divide personnel requirements into sections5.1.1- 5.1.95.1.1 General5.1.2 Personnel qualification5.1.3 Job description5.1.4 Personnel introduction to the organizational environment5.1.5 Training5.1.6 Competence assessment5.1.7 Reviews of staff performance5.1.8 Continuing education and professional development5.1.9 Personnel records• Responsibilities of lab director moved out

5.1 Personnel5.1.1new5.1.2new

5.1.4new

Documented procedure: personnel management

Personnel qualificationsผู้บริหารระบคุณุสมบตับิคุลากรในทกุตําแหน่งเป็นลายลกัษณ์ฯPersonnel qualification: appropriate education,training, experience and demonstrated skills

Personnel introduction to the org environmentLab has a programme to introduce new staff :Department or area in which the person will work,terms and condition of employment, stafffacilities, health and safety requirement,occupational health service.

5.1 Personnel

5.1.5Amended/new •Lab provide training for all personnel

-Quality Management System-Assigned work processes and procedures-Application of LIM-Health and safety, prevention or containment ofeffect of adverse incident-Ethics (จริยธรรม)-Confidentiality of patient information•Personnel are undergoing training supervised atall time•Effectiveness of training programme periodicallyreviewed

5.1 Personnel5.1.6Sigeditorial

• Assess the competence of each personnel to performassigned task following training• Reassessment at regular intervals• Retraining occur when necessary• Competence of lab staff can be assessed by anycombination or all following approaches * Note 1-Direct observation of routine work processes andprocedure, 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 Personnel5.1.7new

5.1.8Amended/new

Review of staff performanceReviews of staff performance to maintain or improve thequality of service

Continuing education and professional development•A continuing education programme available to personnelwho 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 Personnel5.1.9amended

• Record of all personnel maintained• Record readily available and include1. Copy of certification when applicable2. Introduction of new staff to the lab environment

(Orientation)3. Reviews of staff performance4. Reports of accidents, exposure to occupational hazards5. Training in current job tasks6. Competency assessment7. Records of continuing edu and achievements8. Immunization status9. JD10. Previous work experience• Records are not stored in the lab

Lab equipment , reagent , consumables

5.3 Lab equip, reagent, consumablesNote •Lab equipment: hardware and software of

instruments, measuring systems, lab informationsystem (LIS)

•Reagent: reference materials, calibrators & qualitycontrol materials

•Consumables: culture media, pipette tips, slide etc

5.3 Lab equip, reagent, consumablesSig editorial

5.3.1.1 general5.3.1.2 acceptance testing5.3.1.3 instruction for use5.3.1.4 cal and metrological traceability5.3.1.5 equipment maintenance and repair5.3.1.6 adverse incident reporting5.3.1.7 records

5.3 Lab equip, reagent, consumablesSig editorial

5.3.1.1 general5.3.1.2 acceptance testing5.3.1.3 instruction for use5.3.1.4 cal and metrological traceability5.3.1.5 equipment maintenance and repair5.3.1.6 adverse incident reporting5.3.1.7 records

5.3 Lab equip, reagent, consumables5.3.1.1 General

• Procedure for selection, purchasing andmanagement of equipment•Lab replace equipment as needed to ensure thequality 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, consumables5.3.1.4new

Equipment calibration and metrological traceability• Procedure for calibration of equip that direct ofindirect affects exam results include:•Metrological traceability must be to a referencematerial

5.3.1.7 Equipment records Performance records include copies ofreport/certificates of all calibrations and/orverifications.

5.3 Lab equip, reagent, consumables5.3.25.3.2.1new5.3.2.2new

5.3.2.4new

5.3.2.5new

Reagents, consumables•Procedure for reception, storage, acceptance testing,inventory management of reagent and consumable

• Receiving location have adequate storage andhandling capacities to prevent damage/deteriorationand this must be verified, where lab is not receivingfacility•Inventory control system segregate uninspected &unacceptable reagents and consumables from theaccepted ones•Instruction for the use of reagents & consum.availableinventory managementReagent records

5.3 Lab equip, reagent, consumables5.3.2.6

5.3.2.7amended

Reagents, consumables- adverse incident reportingIncident that attributed directly to specific reagents orconsum. Investigated and reported to manufacturerand authoritiesReagent 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 ongoingacceptance for use-where reagent prepared in-house, records mustinclude person (s) undertake the preparation & date

Pre-examination processes

5.4 Pre-exam processesSigeditorial

5.4.1 general5.4.2 info for patients and users5.4.3 request form info5.4.4 primary sample collection and handling5.4.5 Sample transportation5.4.6 Sample reception5.4.7 Pre-exam handling, preparation andstorage

5.4 Pre-exam processes5.4.15.4.2Amended

Procedure for pre-exam (คูมื่อเก็บตวัอยา่ง)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 ofexam or the interpretation of the results• lab’s policy on protection of personal information•Lab ‘s complaint procedure

5.4 Pre-exam processes5. 4.3amended

Request form info• clinically relevant info about patient for examperformance 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’srequest

5.4 Pre-exam pro Pre-exam processes5.4.4.1new5.4.4.3dnew

- Genneralwhere users requires deviations fromdoc collection procedure, these must berecorded in exam results and becommunicated to the appropriatepersonnel-Instruction for collection activitiesinfo regarding sample containers,additives etc must be communicated tothose staff, in situation where collectionperformed by clinical staff.

Examination processes

5.5 Examination processes5.5.1.1amend

5.5.1.2Amend/new

• Selection, verification& validation procedures-preferred procedure: in vitro medical devices,published in established/authoritativetextbook, peer-reviewed texts or journals orinternational consensus stds or guidelines- The identity of persons performing recorded• Verification of exam procedurevalidated procedure must be verified before useinfo to be obtained from the manufacturer / methoddeveloper regarding the performance characteristics ofthe procedureprocedure of verification, the verification mustconfirm that the performance claim met and reviewedby appropriate staff

5.5 Examination processes5.5.1.3amend

-Validation of exam proceduresFor non-std methods, developed methods , stdmethod used outside their intended scope , validatedmethod modified• Performance characteristics: measurement trueness,accuracy, precision, repeatability, intermediateprecision, Uncertainty, analytical specificity, sensitivity,detection limit, quantitation limit, diagnostic spec&sensitivity.

5.5 Examination processes5.5.1.4Amend/new

5.5.2amend

5. 5.3amend/new

Measurement uncertainty of measuredquantity valuesdetermine the uncertainty of results with thequantity valuesWhere exam include a measurement step but do notreport a quantity value, lab should calculate theuncertainty of measurement step in assessing thereliability of the procedure or influence the reportedresult.Biological reference intervals or clinical decision valuesdefine, documented and communicated to usersDocumentation of exam proceduresinclude: patient prep, type of containers& additivesPrinciple of procedure for cal results ; Uncertainty,Envi & safety control, biological reference control etc

Ensuring quality of examination results

5.6 Ensuring quality of examination resultsSigeditorial

5.6.1 general5.6.2 quality control5.6.3 interlab comparison

5.6 Ensuring quality of examination results5.6.1new

5.6.2.2new

5.6.2.3new

performing exam under defined conditionsappropriate pre and post –exam are implementResult are not fabricated

Quality control materialsreact in a manner as close to patient samplesperiodically examined with a frequency based onstability of procedure and the risk of harm to thepatient from erroneous resultQuality control data• procedure to prevent results being released in a QCfailure•When QC rules are violated, results rejected and re-exam after errors•QC data regularly reviewed to detect trends withpreventive action , recorded

5.6 Ensuring quality of examination results5.6.35.6.3.1new

5.6.3.2editorial

Inter laboratory comparisons•Participationparticipate in an inter lab comparisons ( such asEQA,PT programme)Procedure for inter lab comparison participation:responsibility & instruction for participation, anyperformance criteria differed from the prog•Alternative approachescertified ref materials,

sample previously examined,material from cell repositories,exchange of samples with other labsControl materials that are tested daily in inter lab

comparison prog

5.6 Ensuring quality of examination results5.6.3.3new5.6.3.4new

Analysis of inter lab comparison samplesIntegrate the samples into routine workflowEvaluation of lab performance•Performance in interlab comparison reviewedand discussed with relevant staff•when predetermined performance criteria arenot fulfilled ,implement corrective action

Post- examination processes

5.7 Post-examination processes5.7.1Amend/new

Review of resultsSOP include ensuring that personnel reviewthe results of exam before release and evaluateagainst internal quality controlinvolves automatic reporting review criteriato be documented

5.9 Release of results5.9.2New

Automated selection and reporting of resultsrequirement and criteria for automatedresults

5.10 LIM5.10.1

5.10.2

5.10.3

Information system: computerized and non-computerizedAuthorities and responsibilities• define authorities and respon of all personnelWho use the system: acess pat data&info,examination results, change data&results,release the results

LIM :collection, processing, recording etcvalidated and verified, protected, safeguard