Biosafety Management Process at the Research and Biotechnology Division of St. Luke s s Medical Center, Quezon City, Philippines

Transcription

1 Biosafety Management Process at the Research and Biotechnology Division of St. Luke s s Medical Center, Quezon City, Philippines Miguel Martin N. Moreno II, MD, Reynante C. Mirano, MD, Roldan L. Araga, RME, Filipinas F. Natividad, PhD JITMM 2010, 30 Nov ~ 3 Dec, 2010, Bangkok, Thailand

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3 PATIENT CARE FACILITIES IN PATIENT CAPACITY 652 Bed Capacity Regular Beds 27 Suite 315 Private 60 Semi-Private 171 Ward Critical Care Beds 53 Critical Care Nursery Beds 26 Pediatric Nursery OUT-PATIENT CAPACITY 24- hour emergency care With adult and pediatric 24-hour consultant- based triage system Over 2,000 out-patient procedures per day

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5 Research and Biotechnology Division

6 Research & Biotechnology Division Established in 1995 Vision: RBD shall be a prime mover and catalyst in the advancement of medical science through a culture of excellent research at St. Luke s Medical Center. Mission: To propel St. Luke s Medical Center to the realm of world class excellence in total health care through interdisciplinary partnerships between scientists and physicians in the conduct of high quality biomedical research.

7 Research & Biotechnology Division Departments: 1. Research 2. Diagnostics 3. Bioinformatics 4. Special Services 5. Clinical Research 6. St. Luke s Journal of Medicine

8 Research & Biotechnology Division Laboratories and Facilities 1. Microbiology Lab 2. Analytical Chemistry Lab 3. Molecular Diagnostics Lab 4. Protein Lab 5. Molecular Cytogenetics Lab 6. DNA Lab 7. Recombinant DNA Lab 8. Culture Lab 9. Electron Microscopy Facility 10. Animal Facitity 11. Molecular Immunology Lab 12. Stem Cell Lab 13. Mycobacterium tuberculosis Lab 14. Chemical Preparation Lab 15. Wet Lab 16. Bioinformatics Lab

9 Organisms handled at RBD Dengue virus Hepatitis B Virus Hepatitis C Virus Herpes simplex virus Varicella zoster virus Cytomegalovirus Chlamydia trachomatis Human papilloma virus Epstein Barr virus Japanese encephalitis virus Pseudomonas aeruginosa Enteric protozoans Giardia lamblia, Isospora Cryptosporidium, Cyclospora Enteric bacteria Escherichia coli Mycobacterium tuberculosis Acanthamoeba spp. Geobacillus Helicobacter pylori Staphylococcus aureus Naegleria spp. Chikungunya virus

10 Tests performed at RBD 1. Gram s stain 2. Polymerase Chain Reaction (PCR) 3. Reverse transcriptase PCR 4. Genotyping by Restriction Fragment Length Polymorphism (RFLP) 5. High Performance Liquid Chromatography 6. Atomic Absorption 7. Gas Chromatography and Spectrometry 8. Virus culture/isolation 9. Karyotyping 10.Fluorescense in situ Hybridization (F.I.S.H.) 11.Electron microscopy 12.IgM-Capture ELISA 13.Metronidazole Sensitivity Testing

11 Threats & Risks Planning for safety is made by evaluating the risks in the lab Recognizing what the risks are and then introducing procedures, practices, equipment, and facilities to control the identified risks or reduce them to acceptable levels Eliminated or greatly reduced if proper precautions & practices are observed.

12 Risk Assessment.. An objective, repeatable, scientific process... Process in itself.. Identifies a hazard.. Evaluates the risk of the specific hazard.. Evaluates uncertainty

13 Risk Assessment Pathogenicity Infectious dose Mode of transmission Host range Availability of effective preventive measures Availability of effective treatment.

14 Program responsibilities Recognize the need to use potentially hazardous materials for the purpose of diagnostics, research and teaching Commit to ensure the safety of our patients, employees, visitors and students Comply with all regulatory requirements that have an impact on our operations and facilities.

15 Biosafety Management Program To provide an environment for diagnostics & high quality research while maintaining a safe work place, To protect personnel from exposure to infectious agents, To prevent environmental contamination, To act in accordance with applicable local and international laboratory standards.

16 Biosafety Management Program To plan and Implement a culture of Biosafety in the laboratory To ensure combined efforts of laboratory supervisors and employees Use of precautionary measures depends on the material/s involved Control of potential biohazards by Periodically evaluating the risk (risk assessment), Establishing procedures and practices (primary containment), and Comply with facility requirements (secondary containment) for the control of potential biohazards

17 Containment Objective: To reduce exposure of laboratory workers, other persons in the vicinity of the laboratory, and the outside environment, to potentially hazardous agents. Includes laboratory practices and techniques, safety equipment, and facility design.

18 Containment Primary: (laboratory practices, containment equipment, bldg design) represents the procedures, practices and equipment used to prevent the dissemination of research materials from the location where they are being used. Secondary: (walls, ceilings, air locks, self closing doors, ventilation design) consists of the laboratory or facility where the work takes place, including all of the elements that prevent research materials from entering the environment, inadvertently.

19 Standard Operating Procedures General Safety Guidelines Eating, Drinking and Smoking Housekeeping and Maintenance Waste segregation & disposal Spills and Accident Reporting Audits

20 Standard Operating Procedures 1 3 2

21 Standard Operating Procedures 4

22 Standard Operating Procedures

23 Standard Operating Procedures

24 Standard Operating Procedures

25 Standard Lab Control Measures Hygiene Practices Ventilation Safety Equipment Personal Protective Equipment Committees IACUC, ISRB, IERB, DDB

26 Standard Operating Procedures

27 Standard Operating Procedures

28 Standard Operating Procedures

29 Safe Handling in the Lab Hazard Identification Labeling Compressed Gas Hazards

30 Emergency Procedures SLMC Infection Control Team Basic Emergency Response Injury and Illness B.E.P.A.D.C.T. (Biosafety, Emergency Preparedness and Disaster Control Team)

31 B.E.P.A.D.C.T. Biosafety, Emergency Preparedness and Disaster Control Team Ensures a safe, functional and effective environment for all our patients, personnel and other individuals in the medical center Prepares preventive measures and emergency response plans for the entire medical center Assures the outside community that they are well taken care of in a safe environment.

32 B.E.P.A.D.C.T.

33 B.E.P.A.D.C.T. A B

34 B.E.P.A.D.C.T. B A

35 Acknowledgements St. Luke s Medical Center, Quezon City, Philippines ( )