Presentation on theme: "นางสุขใจ ผลอำไพสถิตย์ 30 กรกฎาคม 2557"— Presentation transcript:
1 นางสุขใจ ผลอำไพสถิตย์ 30 กรกฎาคม 2557 ISO 15189:2012 Medical laboratories-Requirements for Quality and competenceนางสุขใจ ผลอำไพสถิตย์30 กรกฎาคม 2557
2 เตรียมความพร้อมในการขอรับรอง ISO 15189:2012 ปี 2558
3 Improved layout & listing of subclauses Reference: Gap analysis of ISO 15189:2012 andversion 2007 (NATA); issued 2013Summary of changesImproved layout & listing of subclausesMore logical ordering of subclausesTwo 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 competenceDefinitions- 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, 2012ISO 15189:2007ข้อกำหนดข้อกำหนดISO 15189:2012ข้อกำหนดข้อกำหนด
7 Personnel (Significant editorial) 5.1Personnel (Significant editorial)Divide personnel requirements into sections5.1.1 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 recordsResponsibilities of lab director moved out
8 Documented procedure: personnel management Personnel qualifications 5.1Personnel5.1.1new22.214.171.124.4Documented procedure: personnel managementPersonnel qualificationsผู้บริหารระบุคุณสมบัติบุคลากรในทุกตำแหน่งเป็นลายลักษณ์ฯPersonnel qualification: appropriate education, training, experience and demonstrated skillsPersonnel 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.
9 Lab provide training for all personnel Quality Management System 5.1Personnel5.1.5Amended/newTrainingLab provide training for all personnelQuality Management SystemAssigned work processes and proceduresApplication of LIMHealth and safety, prevention or containment of effect of adverse incidentEthics (จริยธรรม)Confidentiality of patient informationPersonnel are undergoing training supervised at all timeEffectiveness of training programme periodically reviewed
10 5.1 Personnel 5.1.6 Competence assessment Sig editorialCompetence assessmentAssess the competence of each personnel to perform assigned task following trainingReassessment at regular intervalsRetraining occur when necessaryCompetence of lab staff can be assessed by any combination or all following approaches * Note 1Direct observation of routine work processes and procedure, safety practiceDirect ob of equipment maintenance and function checksMonitoring the recording and reporting the exam resultsReview of work recordAssessment of problem solving skill
11 5.1 Personnel 5.1.7 5.1.8 Review of staff performance new5.1.8Amended/newReview of staff performanceReviews of staff performance to maintain or improve the quality of serviceContinuing education and professional developmentA continuing education programme available to personnel who participate in managerial and technical process.Personnel must take part in continuing educationEffectiveness of the edu pro reviewed periodicallyPersonnel take part in regular professional development
12 5.1 Personnel 5.1.9 Personnel record amendedPersonnel recordRecord of all personnel maintainedRecord readily available and includeCopy of certification when applicableIntroduction of new staff to the lab environment (Orientation)Reviews of staff performanceReports of accidents, exposure to occupational hazardsTraining in current job tasksCompetency assessmentRecords of continuing edu and achievementsImmunization statusJDPrevious work experienceRecords are not stored in the lab
14 Lab equip, reagent, consumables Note 5.3Lab equip, reagent, consumablesNoteLab equipment: hardware and software of instruments, measuring systems, lab information system (LIS)Reagent: reference materials, calibrators & quality control materialsConsumables: culture media, pipette tips, slide etc
15 Lab equip, reagent, consumables 5.3Lab equip, reagent, consumablesSig editorialLab equipgeneralacceptance testinginstruction for usecal and metrological traceabilityequipment maintenance and repairadverse incident reportingrecords
16 Lab equip, reagent, consumables 5.3Lab equip, reagent, consumablesSig editorialreagent and consumablesgeneralacceptance testinginstruction for usecal and metrological traceabilityequipment maintenance and repairadverse incident reportingrecords
17 Lab equip, reagent, consumables 126.96.36.199 GeneralProcedure for selection, purchasing and management of equipmentLab replace equipment as needed to ensure the quality of exam resultsEquipment instructions for uselab has procedures for safe handling, transport, storage and use of equip to prevent its contamination
18 Lab equip, reagent, consumables 188.8.131.52 new Equipment calibration and metrological traceabilityProcedure for calibration of equip that direct of indirect affects exam results include:Metrological traceability must be to a reference materialEquipment records Performance records include copies of report/certificates of all calibrations and/or verifications.
19 Lab equip, reagent, consumables 5.3.2 184.108.40.206 new 220.127.116.11 Reagents, consumablesProcedure for reception, storage, acceptance testing, inventory management of reagent and consumableReceiving location have adequate storage and handling capacities to prevent damage/deterioration and this must be verified, where lab is not receiving facilityInventory control system segregate uninspected & unacceptable reagents and consumables from the accepted onesInstruction for the use of reagents & consum. availableinventory managementReagent records
20 Lab equip, reagent, consumables 18.104.22.168 amendedReagents, 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
22 5.4Pre-exam processesSig editorial5.4.1 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
23 Procedure for pre-exam (คู่มือเก็บตัวอย่าง) 5.4Pre-exam processes22.214.171.124.2AmendedProcedure for pre-exam (คู่มือเก็บตัวอย่าง)information for patients and userslocation, type of clinical services, Opening hours of labExam offered, sample volume, special precaution, TAT,biological reference intervals,clinical decision valuesInstruction for completion request form, collectioninstruction for transportation, special handling needsCriteria for accepting, rejecting samplea list of factors known to affect the performance of exam or the interpretation of the resultslab’s policy on protection of personal informationLab ‘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 purposeFamily history, travel and exposure historydate and time of sample collection, receiptlab cooperate with users in clarifying the user’s request
25 5.4 Pre-exam pro Pre-exam processes 126.96.36.199 new 188.8.131.52d - 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 activitiesinfo regarding sample containers, additives etc must be communicated to those staff, in situation where collection performed by clinical staff.
27 Examination processes 184.108.40.206 amend Amend/newSelection, 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 recordedVerification 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
29 Examination processes 220.127.116.11 Amend/new5.5.2amendamend/newMeasurement uncertainty of measured quantity valuesdetermine the uncertainty of results with the quantity valuesWhere 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 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
30 5.6 Assuring quality of examination procedures Ensuring quality of examination results
31 Ensuring quality of examination results 5.6Ensuring quality of examination resultsSig editorialgeneral5.6.2 quality controlinterlab comparison
32 Ensuring quality of examination results 5.6Ensuring quality of examination results5.6.1newperforming exam under defined conditionsappropriate pre and post –exam are implementResult are not fabricatedQuality 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 dataprocedure to prevent results being released in a QC failureWhen QC rules are violated, results rejected and re-exam after errorsQC data regularly reviewed to detect trends with preventive action , recorded
33 Ensuring quality of examination results 5.6Ensuring quality of examination results5.6.3neweditorialInter laboratory comparisonsParticipationparticipate 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 progAlternative 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
34 Ensuring quality of examination results 5.6Ensuring quality of examination resultsnewnewAnalysis of inter lab comparison samplesIntegrate the samples into routine workflowEvaluation of lab performancePerformance in interlab comparison reviewed and discussed with relevant staffwhen predetermined performance criteria are not fulfilled ,implement corrective action
36 Post-examination processes 5.7Post-examination processes5.7.1Amend/newReview 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
40 5.10LIM18.104.22.168.25.10.3Information system: computerized and non-computerizedAuthorities and responsibilitiesdefine authorities and respon of all personnelWho use the system: acess pat data&info, examination results, change data&results, release the resultsLIM :collection, processing, recording etcvalidated and verified, protected, safeguard