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

เตรียมความพร้อมในการขอรับรอง ISO 15189:2012 ปี 2558

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

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 ข้อกำหนด 4.1-4.15 ข้อกำหนด 5.1-5.8 ISO 15189:2012 ข้อกำหนด 4.1-4.15 ข้อกำหนด 5.1-5.10

5.1 Personnel

Personnel (Significant editorial) 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

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.

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

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

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

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

5.3 Laboratory equipment Lab equipment , reagent , consumables

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

Lab equip, reagent, consumables 5.3 Lab equip, reagent, consumables Sig editorial Lab equip 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

Lab equip, reagent, consumables 5.3 Lab equip, reagent, consumables Sig editorial reagent and consumables 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

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

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.

Lab equip, reagent, consumables 5.3.2 5.3.2.1 new 5.3.2.2 5.3.2.4 5.3.2.5 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

Lab equip, reagent, consumables 5.3.2.6 5.3.2.7 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

5.4 Pre-examination procedure Pre-examination processes

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

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

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

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.

5.5 Examination procedure Examination processes

Examination processes 5.5.1.1 amend 5.5.1.2 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

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.

Examination processes 5.5.1.4 Amend/new 5.5.2 amend 5. 5.3 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

5.6 Assuring quality of examination procedures Ensuring quality of examination results

Ensuring quality of examination results 5.6 Ensuring quality of examination results Sig editorial 5.6.1 general 5.6.2 quality control 5.6.3 interlab comparison

Ensuring quality of examination results 5.6 Ensuring quality of examination results 5.6.1 new 5.6.2.2 5.6.2.3 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

Ensuring quality of examination results 5.6 Ensuring quality of examination results 5.6.3 5.6.3.1 new 5.6.3.2 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

Ensuring quality of examination results 5.6 Ensuring quality of examination results 5.6.3.3 new 5.6.3.4 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

5.7 Post-examination procedures Post- examination processes

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

5.9 Release of results

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

5.10 Laboratory Information Management

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