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SAFETY&QUALITYAND
DISEASE CONTOL
bySirima Pattamadilok
Thai-NIH, DMScJanuary 19, 2009
การจัดการความรูแบบการจัดการความรูแบบบรูณาบรูณาการการThe four functions of management : POLC
Planningกําหนดสิ่งที่ตองการบรรลุ
กําหนดวัตถุประสงค และ
ขั้นตอนที่จะบรรลุผล
Organizationจัดการทรัพยากร
จัดกิจกรรมแตละคน
และกลุมเพื่อปฏิบัติตามแผน
Controllingตรวจสอบ ควบคุม ติดตาม
ผลงานกับเปาหมาย และ
ปรับปรุงแกไขใหถูกตอง
Leadingกระตุนใหทํางาน
เพื่อบรรลแุผน
ManagementProcess
The Framework’s nine dimensions for the assessment of health system performance include appropriate, effective, responsive, continuous, sustainable, accessible and capable, all considered relevant (along with the safety dimension) to the quality of health care services.
International Standards for labsInternational Standards for labsInternational Standards for labs
• ISO/IEC 17025:2005General Requirement for the Competency of Testing and Calibration Laboratories1st edition 1999
• ISO/IEC 15189:2007 (Medical laboratories)
Requirement for Quality and Competency1st edition 2003
International Standards for labsInternational Standards for labs
• ISO 15190:2003 Requirement for safe practices in the medical laboratory1st edition 2003
ISO 15190 : Medical laboratories-Requirement for safety
specifies requirements to establish and maintain a safe working environment in a medical laboratory.to ensure that there is a named person ultimately responsible and that all employees take personal responsibilityfor their own safety at work and, the safety of others who may be affected by it.
ISO 15190 : Medical laboratories-Requirements for safety
Every task requires risk assessment, with the aim that hazards be eliminatedwherever possible.
ISO 15190 : Medical laboratories-Requirement for safety
Where this cannot be done, the risk from each hazard is reduced to as a level as practicable, using the following order of priority:a) by substitution;b) by containment; orc) by the use of personal protective measures and equipment.
ISO 15190 : Medical laboratories-Requirement for safety
“ Safety is the primary consideration; cost is of secondary importance.”
ISO 15190 : Medical laboratories-Requirement for safety
1. Scope2. Normative references3. Terms and definitions4. Risk group classification
ISO 15190 : Medical laboratories-Requirement for safety
5. Management requirements:5.1 Management responsibilities:
Laboratory management shall have responsibility for the safety of all employees and visitors to the laboratory. The ultimate responsibility shall rest with laboratory director or a named person of equivalent standing
ISO 15190 : Medical laboratories-Requirement for safety
5.2 Management of staff health:All personnel shall have documented evidence of training related to potential risks associated with working with any medical (clinical) laboratory facility.
ISO 15190 : Medical laboratories-Requirement for safety
5.2 Management of staff health (cont.): -All personnel shall be advised to informtheir family doctor/personal physician that they work in a medical laboratory.-All personnel should be strongly encouraged to have immunizations to prevent infections associated with organisms to which the person is likely to be exposed.
ISO 15190 : Medical laboratories-Requirement for safety
5.2 Management of staff health (cont.):Record of immunization should be keptin accordance with ISO 15189
ISO 15190 : Medical laboratories-Requirement for safety
6. Designing for safety:6.1 Preliminary considerations: No structural or engineering work shall be undertaken without the appropriate permission being given by the laboratory director or his/her nominated representative.
ISO 15190 : Medical laboratories-Requirement for safety
6.2 General design requirements:Laboratories shall be designed to ensurethat containment of microbiological, chemical, radiological and physical hazards is appropriate to level of assessed risks in technical work areas, and provides a safe working environment in associated office areas and adjoining public space to limit risk to the surrounding community.
ISO 15190 : Medical laboratories-Requirement for safety
6.3 Physical conditions:6.3.1 Lighting6.3.2 Temperature6.3.3 Ventilation6.3.4 Noise6.3.5 Ergonomic6.3.6 Design for working with viable
pathogens
ISO 15190 : Medical laboratories-Requirement for safety
6.3.7 Door signs6.3.8 Laboratory security:
-lockable door : internal door-locked freezers-limited access -threat of theft
ISO 15190 : Medical laboratories-Requirement for safety
7. Staffing, procedures, documentation, inspection and records:-7.1 Laboratory Safety Officer-7.2 Procedures-7.3 Safety programme audits and inspection:
7.3.1 Safety programme audits7.3.2 Safety inspection
ISO 15190 : Medical laboratories-Requirement for safety
7.4 Safety manual:a) fire preventionb) electrical safetyc) chemical safetyd) radiatione) microbiological hazards; andf) hazardous waste disposal
ISO 15190 : Medical laboratories-Requirement for safety
7.5 Records:- General- Occupational illness, injury, and adverse incident records- Risk assessment records- Hazardous waste records
ISO 15190 : Medical laboratories-Requirement for safety
8. Identification of hazards9.Reporting of incidents, injury, accidents and occupational illnesses10. Training11. Personnel responsibilities
-11.1 Food, drink and like substances-11.2 Cosmetics, hair, beards and
jewellery
ISO 15190 : Medical laboratories-Requirement for safety
-11.3 Immunization status-11.4 Personal property-11.5 Festive decorations
12. Clothing and personal protective equipment (PPE):
-12.1 Protective clothing in the laboratory-12.2 Protective clothing outside the
laboratory
ISO 15190 : Medical laboratories-Requirement for safety
-12.3 Face and body protection-12.4 Gloves-12.5 Footwear-12.6 Respiratory protection-12.7 Handwashing-12.8 Training-12.9 Equipment
ISO 15190 : Medical laboratories-Requirement for safety
-12.10 Eyewash stations-12.11 Emergency showers
13. Good housekeeping practices 14. Safe work practices-14.1 Safe work practices with all
material of biological origin-14.2 Special requirements for working
in microbiology laboratories
ISO 15190 : Medical laboratories-Requirement for safety
15. Aerosols16. Microbiological safety cabinets, chemical safety hoods and cabinets17. Chemical safety:-17.1 Measures to avoid chemical
contamination-17.2 Emergency measures applicable when
chemical contamination has occurred-17.3 Discarded chemicals
ISO 15190 : Medical laboratories-Requirement for safety
18. Radiation safety:-18.1 Radionuclides-18.2 Radiation protection advisors, officers, and supervisors-18.3 Workplace monitoring-18.4 UV and laser light sources (including light from high-intensity source)-18.5 Microwave equipment
ISO 15190 : Medical laboratories-Requirement for safety
19. Fire precautions-19.1 Construction-19.2 Secondary exits-19.3 Alarm systems-19.4 Fire risk reduction strategies-19.5 Storage of flammable materials-19.6 Fire safety training programmes-19.7 Firefighting equipment
ISO 15190 : Medical laboratories-Requirement for safety
20. Emergency evacuations21. Electrical equipment:
- Designed and manufactured to comply with appropriate safety requirement
- ISO/IEC 61010- Back-up power supplies
ISO 15190 : Medical laboratories-Requirement for safety
Transport of samples:
“All samples shall be transported to the laboratory in such a manner as to prevent contamination of workers, patients, or the environment.”
ISO 15190 : Medical laboratories-Requirement for safety
Waste disposal:
“Laboratory waste disposal shall be managed in accordance with national, regional, or local regulations.”
ISO 15190 : Medical laboratories-Requirement for safety
Laboratory waste management shall have the following objectives:
a) minimizing the hazards in handling, collecting, transporting, treating and disposing of waste; and
b) minimizing harmful effects to the environment.
คน
เชื้อ สิ่งแวดลอม
บริหารจัดการ
อยางไร
ใหผูปฏิบตัิงาน
ปลอดภัยและปองกัน
การปนเปอนไปสูสิ่งแวดลอม
ความรู
SOPs
ทักษะ
ประชุม / ฝกอบรม
Human Capital
ครอบครอง
แจกจาย
พรบ. - จัดหา- บํารุงรักษา / สอบเทียบ- มาตรฐาน