ISO 15189:2012Medical laboratories-Requirements for

Quality and competence

นางสุ�ขใจ ผลอำ าไพสุถิ�ตย์�30 กรกฎาคม 2557

• เตร�ย์มความพร�อำมในการขอำร�บรอำง ISO 15189:2012ปี! 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 15189:2007

• ข�อำก าหนด 4.1-4.15

• ข�อำก าหนด 5.1-5.8

• ISO 15189:2012

• ข�อำก าหนด 4.1-4.15

• ข�อำก าหนด 5.1-5.10

ISO 15189: 2003, 2007, 2012

5.1 Personnel

5.1 Personnel (Significant editorial)

•Divide personnel requirements into sections5.1.1- 5.1.95.1.1 General5.1.2 Personnel qualification 5.1.3 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 qualificationsผู้��บริ�หาริริะบ�คุ�ณสมบ�ติ�บ�คุลากริในทุ�กติ�าแหน�งเป็�นลายล�กษณ ฯPersonnel 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, staff facilities, health and safety requirement, occupational health service.

5.1 Personnel

5.1.5Amended/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 (จร�ย์ธรรม)-Confidentiality of patient information•Personnel are undergoing training supervised at all time•Effectiveness of training programme periodically reviewed

5.1 Personnel5.1.6Sig 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

5.1 Personnel5.1.7new

5.1.8Amended/new

Review of staff performanceReviews 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

5.1 Personnel5.1.9amended

Personnel record• 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

5.3 Laboratory equipment

Lab equipment , reagent , consumables

5.3 Lab equip, reagent, consumablesNote •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, consumablesSig editorial Lab equip

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 reagent and consumables

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 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, consumables5.3.1.4 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, 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 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. 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 or consum. Investigated and reported to manufacturer and 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 ongoing acceptance for use-where reagent prepared in-house, records must include person (s) undertake the preparation & date

5.4 Pre-examination procedure

Pre-examination processes

5.4 Pre-exam processesSig editorial

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 and storage

5.4 Pre-exam processes5.4.15.4.2Amended

Procedure for pre-exam (คุ��ม"อเก$บติ�วอย�าง)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 processes5. 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

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

- Genneralwhere users requires deviations from doc collection procedure, these must be recorded in exam results and be communicated to the appropriate personnel-Instruction for collection activitiesinfo regarding sample containers, additives etc must be communicated to those staff, in situation where collection performed by clinical staff.

5.5 Examination procedure

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/authoritative textbook, peer-reviewed texts or journals or international 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 / method developer regarding the performance characteristics of the procedureprocedure of verification, the verification must confirm that the performance claim met and reviewed by appropriate staff

5.5 Examination processes5.5.1.3 amend

-Validation of exam proceduresFor 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 processes5.5.1.4Amend/new

5.5.2amend

5. 5.3 amend/new

Measurement uncertainty of measured quantity valuesdetermine 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 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

5.6 Assuring quality of examination procedures

Ensuring quality of examination results

5.6 Ensuring quality of examination resultsSig editorial

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 on stability of procedure and the risk of harm to the patient from erroneous resultQuality 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

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 as EQA,PT programme)Procedure for inter lab comparison participation: responsibility & instruction for participation, any performance criteria differed from the prog•Alternative approachescertified 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 Ensuring quality of examination results5.6.3.3new5.6.3.4 new

Analysis of inter lab comparison samplesIntegrate the samples into routine workflowEvaluation of lab performance•Performance in interlab comparison reviewed and discussed with relevant staff•when predetermined performance criteria are not fulfilled ,implement corrective action

5.7 Post-examination procedures

Post- examination processes

5.7 Post-examination processes5.7.1Amend/new

Review of resultsSOP include ensuring that personnel review the results of exam before release and evaluate against internal quality controlinvolves automatic reporting review criteria to be documented

5.9 Release of results

5.9 Release of results5.9.2New

Automated selection and reporting of resultsrequirement and criteria for automated results

5.10 Laboratory Information Management

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