1 | Page Laboratory Inspections Policies and Procedures Title: Laboratory Inspections Approved by: AIMST IBC Version No: 1.0 Effective: May 2019 1.0 PURPOSE & SCOPE The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for inspecting AIMST Laboratories for compliance with the requirements and guidelines as outlined by the Department of Biosafety, Malaysia in line with Biosafety Act 2007 and Biosafety regulations 2010. 2.0 REFERENCES AIMST Laboratory Biorisk Management Manual Section 8.2 3.0 RESPONSIBILITY It is the responsibility of the IBC and Biosafety officer to ensure the laboratory is inspected at least annually, to ensure identified deficiencies are corrected as soon as possible, and to further investigate any underlying causes or problems. It is the responsibility of the Biosafety Officer to conduct periodic safety and security inspections and advise AIMST Laboratories management on any matters requiring their attention. It is the responsibility of all employees to participate in laboratory inspections, to inspect their workplaces daily to identify and correct hazardous conditions, and to report them to the Biosafety Officer and/or Principal Investigators. 4.0 TERMS and DEFINITIONS “Conformance (C)” means: based on the evidence, the laboratory has demonstrated full implementation of the required criteria.
1.0 PURPOSE & SCOPE The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for inspecting AIMST Laboratories for compliance with the requirements and guidelines as outlined by the Department of Biosafety, Malaysia in line with Biosafety Act 2007 and Biosafety regulations 2010. 2.0 REFERENCES AIMST Laboratory Biorisk Management Manual Section 8.2 3.0 RESPONSIBILITY It is the responsibility of the IBC and Biosafety officer to ensure the laboratory is inspected at least annually, to ensure identified deficiencies are corrected as soon as possible, and to further investigate any underlying causes or problems. It is the responsibility of the Biosafety Officer to conduct periodic safety and security inspections and advise AIMST Laboratories management on any matters requiring their attention. It is the responsibility of all employees to participate in laboratory inspections, to inspect their workplaces daily to identify and correct hazardous conditions, and to report them to the Biosafety Officer and/or Principal Investigators. 4.0 TERMS and DEFINITIONS “Conformance (C)” means: based on the evidence, the laboratory has demonstrated full implementation of the required criteria.
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“Non-Conformance (NC)” means: based on the evidence, the laboratory has not fully or effectively implemented the required criteria. Corrective action must be undertaken to safeguard the safety and security of the staff and/or surrounding community. Minor NC’s are issued where there are isolated instances of failures to meet the required criteria resulting in minimal risk to the safety and security of the staff and the surrounding community. Major NC’s are issued where there is an absence of meeting critical safety and security requirements and/or systemic failures to meet the required criteria. “Not-Verified (NV)” means: the inspector could not confirm conformance because evidence could not be provided or the activity has not yet occurred. “Not-Applicable (NA)” means: the inspector did not confirm conformance because this requirement is not relevant to the laboratory. “Recommendations” means: recommendations have been provided that may assist the laboratory in achieving continual improvement by ensuring more efficient implementation of the requirements. The laboratory is conformant with the required criteria, and the recommendations are opportunities for improvement. 5.0 PROCEDURES 5.1 Introduction The inspection process involves gathering objective evidence through asking questions to laboratory employees about what they are doing, observing how employees are carrying out laboratory activities, examining the laboratory facility and equipment, and examining records (e.g. training records, biological agent inventories, and accident & incident reports). In addition to the formal annual inspection, all employees working in the laboratory are responsible for ongoing day-to-day inspections of their work areas to identify and correct hazardous conditions and to report them to the Biosafety Officer and/or Principal Investigator. Special inspections may also be conducted as a result of changes in laboratory operations, the introduction of new equipment, or after a laboratory accident or incident. Any identified deficiencies are rectified as soon as reasonably possible and further investigated to identify any underlying causes or problems. In cases where identified deficiencies present an unacceptable risk to employees, the public, the environment, the property, security and/or gross disregard to health and safety, AIMST Laboratories management will take immediate action to rectify the situation. Action may include the immediate suspension of the laboratory activity of concern, prohibited entry to the laboratory, and/or removal of hazardous material from the premises until such time as the deficiency is corrected. Records are maintained of all laboratory inspection findings, including the action taken to address any deficiencies and opportunities for improvement. 5.2 Biosafety Evaluation Checklist The laboratory inspection team utilises a Biosafety Evaluation Checklist (see attached BSL-1 and BSL-2 Checklists for Laboratory) based on the requirements of the Department of Biosafety, Malaysia as the minimum criteria to determine compliance with Biosafety Act
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2007 and Biosafety Regulations 2010. The inspection activities encompass the gathering of objective evidence through a combination of examining documentation and inspecting the laboratory. A key first step of the process is information gathering and conducting a detailed risk assessment to gain a thorough understanding of the nature of the current laboratory operations, pathogens worked with, equipment and physical facilities. Consultations with a cross-section of stakeholders are used to garner valuable insight in identifying gaps, challenges, and opportunities for improvement. Both administrative (biosafety program management, occupational health, pathogen inventories, training, laboratory SOPs, personal protective equipment, emergency response) and engineering controls (physical facility design, biosafety cabinets and equipment) are evaluated by the inspection team. Planning & Preparation In order to adequately prepare for and plan the inspection, and to gather information, the inspection team will carry out the following tasks:
Conduct meaningful consultations with relevant facility authorities with may include: biosafety coordinator, Principal Investigator, technicians and scientists, facility and equipment maintenance technicians)
Conduct risk assessment on the activities carried out within the laboratory Review documentation related to the operation of the laboratory (e.g. AIMST
Laboratory Biorisk Management Manual, standard operating practices, biosafety management program, training records, occupational health & safety program, facility maintenance program)
Review past inspection reports (to determine if any trends or systemic problems are occurring)
On-site Inspection In order to evaluate the physical laboratory facilities and equipment, the inspection team will carry out the following tasks:
Gather objective data by physically inspecting laboratories/supporting infrastructure/equipment, observing activities and practices, asking questions
Inspection Findings & Follow-Up In order to follow-up on the inspection outcomes, the inspection team will carry out the following tasks:
Compile inspection observations and conclusions into compliant and non-compliant findings (including both minor and major deficiencies)
Provide an action plan and prioritised list of recommendations for compliance Follow-up action items, verify for compliance, and track to closure
Inspection Checklist: Biosafety Level 1 Department of Biosafety, Ministry of Natural Resources and Environment
1 August 2015 Version
Applicant/JBK Ref No.:
Inspector:
Premise:
Date:
Principal Investigator:
Time:
Check ( ) in the appropriate box that best describes the laboratory in which work will be performed.
A. Laboratory Facilities
Yes No NA Details/Comment
1. Is a universal biohazard symbol for BSL 1 posted at the entrance of the laboratory? Do the sign include name, and phone number of the laboratory supervisor or other responsible personnel?
2. Do laboratories have a sink for hand washing?
3. Is furniture in the laboratory capable of supporting anticipated loads and uses?
4. Are spaces between benches, cabinets and equipment accessible for cleaning?
5. Are bench tops impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals?
6. Is furniture including bench tops in the laboratory covered with a non-porous material that can be easily cleaned?
7. Are laboratory windows that are open to the exterior fitted with screens?
8. Is an autoclave for pre-treatment of laboratory wastes is available?
9. Is an eyewash fountain is readily available in the laboratory?
10. Is an effective integrated pest management programme in place and managed appropriately?
B. Safety Equipment
Yes No NA Details/Comment
11. Is there first aid kit available?
12. Are suitable PPE available and used by laboratory personnel?
13. Is there any storage equipment to keep GM materials ( Example refrigerator)
14. Are the equipment is regularly maintained?
15. Is there a fume hood for working with hazardous chemicals?
C. Work Practices Yes No NA Details/Comment
16. Is there any bio hazardous materials handled in the laboratory?
Inspection Checklist: Biosafety Level 1 Department of Biosafety, Ministry of Natural Resources and Environment
2 August 2015 Version
17. Do personnel wash their hands before leaving the lab?
18. Are mechanical pipetting devices used?
19. Is there a signage available for prohibiting from eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption in the lab?
20. Are work surfaces decontaminated with an effective disinfectant on completion of work especially after spills or splashes of bio hazardous materials?
21. Is a sharp bin available for disposal of and all syringes/ needles/ sharps?
22. Are re-usable sharps properly cleaned and disinfected?
23. Is there a biological spill kit available?
24. Are all wastes that are contaminated with bio hazardous materials autoclaved or decontaminated?
25. Have all personnel been provided information about hazards and risk about their work activity?
26. Are laboratory waste segregated into dedicated waste bins and labelled properly?
D. Records and Documents For :
27. Procurement and transfers of GMO/LMO
28. Biological material /LMO inventory
29. SOPs for contained use activity
30. Staff training and competency
31. Equipment maintenance
32. Decontamination and validation
Additional comments/observations and recommendation :
Inspection Checklist: Biosafety Level 1 Department of Biosafety, Ministry of Natural Resources and Environment
3 August 2015 Version
Inspector’s Signature:
Date:
Inspection Checklist: Biosafety Level 2 Department of Biosafety, Ministry of Natural Resources and Environment
1 August 2015 Version
Applicant/JBK Ref No.:
Inspector:
Premise:
Date:
Principal Investigator:
Time:
Check ( ) in the appropriate box that best describes the laboratory in which work will be performed.
A. Laboratory Facilities
Yes No NA Details/Comment
1. Is a universal biohazard symbol for BSL 2 posted at the entrance of the laboratory? Do the sign include name, and phone number of the laboratory supervisor or other responsible personnel?
2. The design of the facility should be such that laboratory activities are separated from common areas. (Examples offices and pantry)
3. Is a dedicated hand basin of the hands-free operation type provided within each laboratory?
4. Is furniture in the laboratory capable of supporting anticipated loads and uses?
5. Are spaces between benches, cabinets and equipment accessible for cleaning?
6. Are bench tops impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals?
7. Is furniture including bench tops in the laboratory covered with a non-porous material that can be easily cleaned?
8. If windows are present is it closed at all times?
9. Is an autoclave for pre-treatment of laboratory wastes is available in the contained facility?
10. Is an eyewash fountain is readily available in the laboratory?
11. Is an effective integrated pest management programme in place and managed appropriately?
12. Are laboratory floors smooth, easy to clean and resistant to chemicals?
13. Does the ventilation in the laboratory have directional air flow into the laboratory areas?
14. Is there a good housekeeping in the laboratory?
B. Safety Equipment
Yes No NA Details/Comment
15. Is there first aid kit available?
Inspection Checklist: Biosafety Level 2 Department of Biosafety, Ministry of Natural Resources and Environment
2 August 2015 Version
16. Is there a Class II biological safety cabinet in the laboratory, certified annually?
17. Is the BSC suitably located, away from door and air vent?
18. Is the BSC free of equipment or supplies that can block the air grills and disrupt proper airflow?
19. When lab personnel use vacuum lines with bio hazardous materials, are they protected with High Efficiency Particulate Air (HEPA) filters?
20. Is equipment for use or storage of bio hazardous materials (i.e. refrigerator, freezers) labelled with a biohazard symbol?
21. Is GM/LMOs are kept separately from non GM?
22. Is there a fume hood for working with hazardous chemicals?
C. PPE (Personal Protective Equipments) Yes No NA Details/Comment
23. Are suitable PPE available relevant to the hazard on the laboratory and used by laboratory personnel?
24. Are respiratory mask available for aerosol generating infectious work?
25. Are covered shoes/foot cover used in the lab?
D. Work Practices Yes No NA Details/Comment
26. Is there any bio hazardous materials handled in the laboratory?
27. Do personnel wash their hands before leaving the lab?
28. Are mechanical pipetting devices used?
29. Is there a signage available for prohibiting from eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption in the lab?
30. Are work surfaces decontaminated with an effective disinfectant on completion of work especially after spills or splashes of bio hazardous materials?
31. Is a sharp bin available for disposal of and all syringes/ needles/ sharps?
32. Are re-usable sharps properly cleaned and disinfected?
33. Is there a biological spill kit available?
34. Are all wastes that are contaminated with bio hazardous materials autoclaved or decontaminated?
35. Have all personnel been provided information about hazards and risk about their work activity?
Inspection Checklist: Biosafety Level 2 Department of Biosafety, Ministry of Natural Resources and Environment
3 August 2015 Version
36. Are laboratory waste segregated into dedicated waste bins and labelled properly?
37. Are suitable chemical disinfectant used for inactivating liquid waste?
38. Is a medical surveillance program in place for the laboratory personnel? (Example Hep B vaccination)
39. Is there a Laboratory Biosafety Guidelines or Biosafety Manual in the laboratory?
40. Are the lab specific Biosafety procedures incorporated into the Laboratory Biosafety Guidelines or Biosafety Manual?
41. Are needle-locking syringes or safety hypodermic needles used when appropriate?
42. Are bio hazardous materials transported in covered containers to prevent leakage?
43. Is there any incident/accident/laboratory exposure reporting system in place?
44. Is there an ERP in place?
45. Is medical follow-up obtained if appropriate?
46. Are animals and plants not associated with the work prohibited from the laboratory?
47. Are any experiments involving animals and plants carried out in the laboratory?
E. Records and Documents For :
48. Procurement and transfers of GMO/LMO
49. Biological material /LMO inventory
50. SOPs for contained use activity
51. Staff training and competency
52. Equipment maintenance
53. Decontamination and validation
54. Incident/accident/laboratory exposure
Inspection Checklist: Biosafety Level 2 Department of Biosafety, Ministry of Natural Resources and Environment
4 August 2015 Version
Inspector’s Signature:
Date:
Additional comments/observations and recommendation :
LAMPIRAN 3
Inspection Checklist: Biosafety Level 2 (Animal Facility) Department of Biosafety, Ministry of Natural Resources and Environment
1 August 2015 Version
Applicant/JBK Ref No.:
Inspector:
Premise:
Date:
Principal Investigator:
Time: Check ( ) in the appropriate box that best describes the laboratory in which work will be performed.
A. Animal Facilities
Yes No NA Details/Comment
1. Is a universal biohazard symbol for BSL 2 posted at the entrance of the laboratory? Does the signage include name, and phone number of the laboratory supervisor or other responsible personnel?
2. Is the animal facility separated from common areas? (Examples offices and pantry)
3. Are the facilities for laboratory and experimental animals physically separated from other activities?
4. Is a dedicated hand basin of the hands-free operation type provided within animal facility?
5. Is there a separate section for post mortem examination?
6. Are bench tops impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals?
7. Are laboratory floors easy to clean and resistant to chemicals?
8. If the animal facility has windows that open, are they are fitted with insect screens?
9. Are doors to animal containment facilities open inwards?
10. Is an autoclave for decontamination available?
11. Is an eyewash fountain readily available in the animal facility?
12. Is an effective integrated pest management programme in place and managed appropriately?
13. Does the ventilation in the animal facility have directional air flow into the areas?
14. Is there a good housekeeping in the facility?
15. Is any food stored in the facilities refrigerators?
LAMPIRAN 3
Inspection Checklist: Biosafety Level 2 (Animal Facility) Department of Biosafety, Ministry of Natural Resources and Environment
2 August 2015 Version
B. Safety Equipment B. Safety Equipment
Yes No NA Details/Comment
16. Is there first aid kit available?
17. Is there a Class II Biological Safety Cabinet (BSC) in the laboratory and certified annually? (If needed)
18. Is the BSC suitably located, away from door and air vent?
19. Is the BSC free of equipment or supplies that can block the air grills and disrupt proper airflow?
20. When lab personnel use vacuum lines with bio hazardous materials, are they protected with High Efficiency Particulate Air (HEPA) filters?
21. Is equipment for use or storage of bio hazardous materials (i.e.? Refrigerator, freezers) labelled with a biohazard symbol?
22. Is GM animal kept in separate room from normal animal?
23. Are animals housed in primary biosafety containment equipment appropriate for the animal species and hazardous work activities?
24. Are disposable personal protective equipment and other contaminated waste appropriately contained and decontaminated prior to disposal?
C. Personal Protective Equipment (PPE) Yes No NA Details/Comment
25. Are suitable PPE available relevant to the hazard on the laboratory and used by laboratory personnel?
26. Are respiratory mask available for aerosol generating infectious work?
27. Are covered shoes/shoes cover/boots cover used in the animal facility?
28. Is reusable clothing appropriately contained and decontaminated before being laundered?
29. Are eye, face, and respiratory protection used in rooms containing
infected animals (as dictated by a risk assessment)?
D. Work Practices Yes No NA Details/Comment
30. Is there any bio hazardous materials (e.g. recombinant DNA,
cancerous cells etc.) handled in the laboratory?
31. Do personnel wash their hands before leaving the laboratory?
32. Are mechanical pipetting devices used?
LAMPIRAN 3
Inspection Checklist: Biosafety Level 2 (Animal Facility) Department of Biosafety, Ministry of Natural Resources and Environment
3 August 2015 Version
33. Are work surfaces decontaminated with an effective disinfectant
on completion of work especially after spills or splashes of bio
hazardous materials?
34. Is a sharp bin available for disposal of and all syringes/ needles/
sharps?
35. Are re-usable sharps properly cleaned and disinfected?
36. Are needle-locking syringes or safety hypodermic needles used
when appropriate?
37. Is there a biological spill kit available?
38. Are all wastes that are contaminated with bio hazardous materials
autoclaved or decontaminated?
39. Have all personnel been provided information about hazards and
risk about their work activity including safe animal handling?
40. Are facility waste segregated into dedicated waste bins and
labelled properly?
41. Is there a suitable liquid waste decontamination system?
42. Is a medical surveillance program in place for the laboratory
personnel? (Example Hep B vaccination)
43. Is there a Laboratory Biosafety Guidelines or Biosafety Manual in
the laboratory?
44. Are bio hazardous materials transported in covered containers to
prevent leakage?
45. Is there an Emergency Response Plan (ERP) in place?
46. Is medical follow-up obtained if appropriate?
47. Are animals and plants not associated with the work found in the
laboratory?
48. Are all wastes from the animal room (including animal tissues,
carcasses, and bedding) transported from the animal room in leak-
proof, covered containers?
49. Are wastes from the animal room disposed of in compliance with
applicable institutional, local and state requirements?
50. Are all potentially infectious materials and animal waste materials
decontaminated by an appropriate method (e.g. autoclave,
chemical disinfection, or other approved decontamination
LAMPIRAN 3
Inspection Checklist: Biosafety Level 2 (Animal Facility) Department of Biosafety, Ministry of Natural Resources and Environment
4 August 2015 Version
methods) before movement outside the areas where infectious
materials and/or animals are housed or manipulated?
51. Is materials to be decontaminated outside of the immediate areas
within the facility where they are separated? Are there a durable,
leak proof, covered container and secured for transport?
52. If yes to (56), does the transport container have a universal
biohazard label?
53. Are there dedicated areas for post-mortem?
54. Is equipment decontaminated before repair, maintenance, or
removal from the areas where infectious materials and/or animals
are housed or manipulated?
55. Are spills involving infectious materials contained, decontaminated,
and cleaned up by staff properly trained and equipped to work
with infectious material?
56. Are cages, used instruments and containers decontaminated
before cleaning?
57. Is there a barrier to prevent escape or entry of animals into the
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