SAFETY&QUALITY AND DISEASE CONTOL. by Sirima Pattamadilok Thai-NIH, DMSc January 19, 2009

Transcription

1 SAFETY&QUALITY AND DISEASE CONTOL by Sirima Pattamadilok Thai-NIH, DMSc January 19, 2009

2 การจ ดการความร แบบบ รณา บ รณาการ The four functions of management : POLC Planning ก าหนดส งท ต องการบรรล ก าหนดว ตถ ประสงค และ ข นตอนท จะบรรล ผล Controlling ตรวจสอบ ควบค ม ต ดตาม ผลงานก บเป าหมาย และ ปร บปร งแก ไขให ถ กต อง Management Process Organization จ ดการทร พยากร จ ดก จกรรมแต ละคน และกล มเพ อปฏ บ ต ตามแผน Leading กระต นให ท างาน เพ อบรรล แผน

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4 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.

5 International Standards for labs ISO/IEC 17025:2005 General Requirement for the Competency of Testing and Calibration Laboratories 1 st edition 1999 ISO/IEC 15189:2007 (Medical laboratories) Requirement for Quality and Competency 1 st edition 2003

6 International Standards for labs ISO 15190:2003 Requirement for safe practices in the medical laboratory 1 st edition 2003

7 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 responsibility for their own safety at work and, the safety of others who may be affected by it.

8 Requirements for safety Every task requires risk assessment, with the aim that hazards be eliminated wherever possible.

9 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; or c) by the use of personal protective measures and equipment.

10 Safety is the primary consideration; cost is of secondary importance.

11 1. Scope 2. Normative references 3. Terms and definitions 4. Risk group classification

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13 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

14 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.

15 5.2 Management of staff health (cont.): -All personnel shall be advised to inform their 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.

16 5.2 Management of staff health (cont.): Record of immunization should be kept in accordance with ISO 15189

17 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.

18 6.2 General design requirements: Laboratories shall be designed to ensure that 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.

19 6.3 Physical conditions: Lighting Temperature Ventilation Noise Ergonomic Design for working with viable pathogens

20 6.3.7 Door signs Laboratory security: -lockable door : internal door -locked freezers -limited access -threat of theft

21 7. Staffing, procedures, documentation, inspection and records: -7.1 Laboratory Safety Officer -7.2 Procedures -7.3 Safety programme audits and inspection: Safety programme audits Safety inspection

22 7.4 Safety manual: a) fire prevention b) electrical safety c) chemical safety d) radiation e) microbiological hazards; and f) hazardous waste disposal

23 7.5 Records: - General - Occupational illness, injury, and adverse incident records - Risk assessment records - Hazardous waste records

24 8. Identification of hazards 9.Reporting of incidents, injury, accidents and occupational illnesses 10. Training 11. Personnel responsibilities Food, drink and like substances Cosmetics, hair, beards and jewellery

25 -11.3 Immunization status Personal property Festive decorations 12. Clothing and personal protective equipment (PPE): Protective clothing in the laboratory Protective clothing outside the laboratory

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28 -12.3 Face and body protection Gloves Footwear Respiratory protection Handwashing Training Equipment

29 Eyewash stations Emergency showers 13. Good housekeeping practices 14. Safe work practices Safe work practices with all material of biological origin Special requirements for working in microbiology laboratories

30 15. Aerosols 16. Microbiological safety cabinets, chemical safety hoods and cabinets 17. Chemical safety: Measures to avoid chemical contamination Emergency measures applicable when chemical contamination has occurred Discarded chemicals

31 18. Radiation safety: Radionuclides Radiation protection advisors, officers, and supervisors Workplace monitoring UV and laser light sources (including light from high-intensity source) Microwave equipment

32 19. Fire precautions Construction Secondary exits Alarm systems Fire risk reduction strategies Storage of flammable materials Fire safety training programmes Firefighting equipment

33 20. Emergency evacuations 21. Electrical equipment: - Designed and manufactured to comply with appropriate safety requirement - ISO/IEC Back-up power supplies

34 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.

35 Waste disposal: Laboratory waste disposal shall be managed in accordance with national, regional, or local regulations.

36 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.

37 คน ความร SOPs ท กษะ ประช ม / ฝ กอบรม Human Capital บร หารจ ดการ อย างไร ให ผ ปฏ บ ต งาน ปลอดภ ยและป องก น ครอบครอง แจกจ าย พรบ. การปนเป อนไปส ส งแวดล อม เช อ ส งแวดล อม - จ ดหา - บ าร งร กษา / สอบเท ยบ - มาตรฐาน

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