Professional Documents
Culture Documents
Aligning with the university’s program, the Duke- process enhanced their safety awareness and made them
NUS Graduate Medical School, a partnership between the more aware of local regulations, many of which may not
NUS and Duke University, USA, established and nurtured have been obvious given that the researchers are from vari-
a safety culture in research laboratories through the imple- ous countries and backgrounds. Thus, the Scheme served as
mentation of laboratory SMS. This article explains how the a platform to increase awareness and increase the rapport
SMS was used as a tool to foster a safety culture and to get between the Safety Team and researchers, which was a key
buy-in from the PIs of research laboratories. factor in cultivating a safety culture. Once laboratories
were enrolled in the Scheme, the PI and her or his team
Materials and Methods took charge of their safety management, with guidance
from the Safety Committee and the Safety Team.
The Scheme was rolled out in August 2010 for 34 PIs The processes involved in rolling out the Certification
involved in wet-bench, laboratory-based research activities Scheme are schematically shown in Figure 1, with detailed
in four research programs: 1) Cancer and Stem Cell Biolo- explanation of the key steps described below.
gy; 2) Cardiovascular & Metabolic Disorders; 3) Emerging
Infectious Diseases; and 4) Neuroscience and Behavioral Planning
Disorders. The implementation of the Scheme was carefully
Safety at Duke-NUS is managed by a Safety Commit- planned before announcing it to the PIs. The Safety Com-
tee and a Safety Team that oversees all aspects of safety mittee and the Safety Team realized that rolling out the
in the school. The Committee reports to the dean of the Scheme as a pilot project would enable them to test the sys-
school and is responsible for maintaining an open channel tem and refine the process as needed. The pilot batch of
of communications with the senior leadership, whose in- eight PIs enrolled for the certification in Aug 2010; the re-
volvement in the SMS is crucial to its successful imple- maining 26 PIs were successfully enrolled in March 2011.
mentation. Comprised of academics and experts in various
fields, the Safety Committee is responsible for setting safe- Briefing and Training
ty policies and guidelines, while the Safety Team is respon- PIs and the research team were briefed about the
sible for their execution. Researchers have the most updat- Scheme and the framework. The briefing sessions served as
ed knowledge about the hazards involved in their research a two-way communication channel to gather feedback and
activities. The Safety Team tapped this knowledge and to get buy-in from the PIs. Each PI was required to nomi-
worked together with the PIs and laboratory members to nate a representative who would serve as the “Safety Lead”
identify risks and establish appropriate mitigating measures. for the laboratory. The Safety Leads, who were the key
This process also enabled the Safety Team to train the PIs liaisons for each laboratory, were further trained in the
and their laboratory members about the process of risk as- methodology, and in turn trained the rest of the laboratory
sessment and implementation of control measures. This members.
Table 1
Elements of the NUS SMS
1. General Requirements
2. Commitment of the group to the OH&S Management System
3. Hazard Identification, Risk Assessment, and Determining Controls
4. Legal and other requirements
5. Objectives and Programs
6. Resources, Roles, Responsibility, Accountability, and Authority
7. Competence, Training, and Awareness
8. Communication, Participation, and Consultation
9. Documentation and Document Control
10. Operational Control
11. Emergency Preparedness and Response
12. Performance Measurement and Monitoring
13. Incident Investigation, Corrective Action, and Preventive Action
14. Internal Audit
Figure 1
Development and implementation of a laboratory SMS: Steps taken and outcomes achieved.
The Safety Team, together with the researchers, identi- Researchers were trained to perform risk assessments
fied and prepared several risk assessment templates to en- for their research activities. Examples of factors they con-
compass the different activities (e.g., handling of chemi- sidered include:
cals, handling of infective agents, handling tissue culture, • Materials used (e.g., biological, chemical)
etc.). Each laboratory was required to customize these tem- • Concentration and quantity of material used
plates for their own activities and identify appropriate con- • Toxicity (e.g., microbial toxins)
trol measures depending on the types of procedures and • Genetic modifications
research materials involved. This exercise was done in a • Biological, chemical, radiological mixtures/interactions
group with all the members of the laboratory playing an • Usage of drugs of known/unknown toxicity
active role in the risk assessment exercise. At the end of • Waste management
this risk assessment training and exercise, all members of • Procedural risks (e.g., potential for aerosol generation)
the laboratory were very adept at performing risk assess- • Instruments used (e.g., sharps, centrifuges)
ment for their activities. Great emphasis was placed on the • Type of work (e.g., whether repetitive procedures would
need to perform hazard identification and risk assessment be used, resulting in fatigue)
as a team, with the person doing the activity taking a key • Behavioral factors (e.g., working too fast, low opinion
role. Risk assessments were required to be performed for of safety programs)
all activities regardless of where they were performed, for In addition to the above factors, the researchers were
example in common areas, instrument rooms, vivaria, etc. trained to rely upon their experience and realistic scenarios
Table 2a
3x3 Matrix Used for Risk Assessment
Likelihood
Likely (3) Possibly (2) Unlikely (1)
Low (1) 3 2 1
Severity Medium (2) 6 4 2
High (3) 9 6 3
Risk = Severity x Likelihood, varies from 1 to 9
<3 Acceptable Residual Risk Low
3, 4 Additional Risk Control to be considered Medium
>4 Additional Risk Control required High
Table 2b
Assessing the Severity of the Risk
Score Severity Description
No injury, injury or ill health requiring first aid treatment only—includes minor cuts and
1 Low (Minor)
bruises, irritation, ill-health with temporary discomfort
Injury requiring medical treatment or ill-health leading to disability, includes lacerations,
2 Medium (Moderate)
burns, sprains, minor fractures, dermatitis, deafness, work-related upper limb disorders
Fatal serious injury or life threatening, occupational disease, includes amputations, major
3 High (Major)
fractures, multiple injuries, occupational cancer, acute poisoning and fatal diseases
Table 2c
Determining Likelihood
Score Severity Description
1 Unlikely (Remote) Not likely to occur (has not occurred in the PI’s laboratory or similar laboratory setup)
2 Possible (Occasional) Possible or known to occur (has occurred in the PI’s laboratory or similar setup)
Common or repeating occurrence (has occurred repeatedly in the PI’s laboratory or
3 Likely (Frequent)
similar laboratory setup)
to adequately assess risk. Researchers were trained to walk actually performing the specific activity to ensure that the
through an activity in a “start-to-finish approach” to identi- risk assessment was not merely a paper exercise. An exam-
fy and address all risks associated with the activity. Some ple of a risk assessment is shown in Table 3.
examples of factors taken into consideration include:
• Past experience/incidents Standard Operating Procedures (SOPs)
• Number of years of experience of the researchers SOPs were developed at the university, school, or la-
• Availability of adequate supervision boratory level based on applicability. Specific SOPs for
• Complexity of the activity laboratories were developed only when the university or
• Number of personnel involved in the activity school-level SOP was not able to adequately address the
• Frequency of performing the activity risk. An example of such a laboratory-level SOP would be
• Degree of control (e.g., involvement of non-laboratory the injection of radioactive-labeled material into mice. In
trained persons) this case, a laboratory-specific SOP was drawn up to man-
• Adequacy of administrative controls (standard operat- age radioactive animal carcass disposal.
ing procedures) and training
Internal and External Audits
Creation of Generic Risk Assessment Templates An internal audit was conducted by specially trained
and Customization by Each Laboratory peers who, together with members of the Safety Team,
Generic risk assessment templates were created based performed the audit. Internal audits mimicked formal exter-
on common research activities carried out in various labor- nal audits, including document review, laboratory site vis-
atories. The following generic templates were developed its, and interviews with laboratory members. The findings
in discussion with the core group: 1) Tissue culture work; of the internal audit were made known to the PI in a written
2) Radio-isotope work; 3) Handling of chemicals; 4) Bacte- report with corrective action required before the external
rial work; 5) Nucleic acid work; 6) Microscopy and immu- audit. This process of internal audit allowed the PI and his
nofluorescence; and 7) Protein work. or her laboratory members to familiarize themselves with
The generic templates provided a standardized frame- the audit methodology. Furthermore, it allowed the Safety
work for the laboratories, which the Safety Leads in each Team to assess the laboratory for its preparedness and to
laboratory used to add information specific to their laborato- further train the laboratory members on the value of imple-
ry activities and compile in their register. This was achieved menting an SMS.
through discussions with the laboratory member(s) who was External audits were conducted by trained auditors
Table 3
Example of Activity-based Risk Assessment
Description/ Existing
Possible Risk Additional
No. Details of Steps Hazards Risk Severity Likelihood
Accidents Level Control
in Activity Control
1 Get vials from Possible Frostbite Use 2 1 2
Liquid nitrogen Exposure to cryogloves
liquid and face
nitrogen shields
2 Thawing of Breakage/ Eye injury Use 3 1 3
human samples explosion of due to cryogloves,
stored in liquid vial due to explosion face shield
nitrogen the of vials and lab
temperature coats when
difference handling
frozen
vials.
Exposure to Lab Work in a 3 2 6 Hepatitis B
human blood acquired BSL-2 lab, vaccination
borne infection Use class II (occupation
pathogens Biosafety al health
(e.g., HBV, cabinet, program)
HCV, HIV goggles and
etc.) from lab coat
human
cells—(Risk
Group 2)
either from the university’s Safety Office or external agen- Future Plans
cies. Of the 34 PIs who underwent the audit, 31 were en-
rolled in the Scheme on the first attempt. The remaining The Scheme has now been in force for just over 2
three, were found to have gaps in the implementation of the years and the Duke-NUS Safety Team will continue to
SMS, and were given 3 months to address them. monitor its efficacy. In particular, the Safety Team hopes to
wean researchers off a dependence on the Safety Team so
Conclusions that researchers are able to self-regulate the laboratory’s
safety more effectively. Over the next 3 years, the Safety
Currently, 34 PIs in the school are enrolled in the Team aims to develop parameters to objectively measure
Scheme. Newly hired PIs are given a year to prepare their the success of this Scheme.
laboratories for the Scheme, during which they work close-
ly with the Safety Team to put a robust SMS in place. Once Acknowledgments
certification is achieved, the laboratory register becomes
an integral part of the laboratory. It is used for training This project was made possible by the Duke-NUS
and orienting new members to the laboratory and during Graduate Medical School, Singapore’s operating budget.
monthly inspections to ensure that risk mitigating measures *Correspondence should be addressed to Viji Vijayan at
are followed. The laboratory register also serves as a one- viji.vijayan@duke-nus.edu.sg.
stop reference for regulatory requirements in terms of rec-
ords and documentation. References
Several benefits have been derived from this Scheme
including: Bushell S. Implementing plan, do, check and act. The Jour-
• Safety awareness has increased significantly among nal for Quality and Participation. 1992;15(5):58.
every member of the research team. This is seen in the in- Granerud L, Rocha RS. Organisational learning and contin-
creased vocalization of safety concerns during laboratory uous improvement of health and safety in certified manu-
meetings. facturers. Safety Science. 2011;49(7):1030-9.
• The bottom-up approach allowed every member of the Herrero SG, Saldaña M., del Campo M, Ritzel DO. From
laboratory, from students to post docs, to take an active part the traditional concept of safety management to safety
addressing safety issues. integrated with quality. J Safety Res. 2002;33(1):1-20.
• Researchers are trained and empowered to identify and Hohnen P, Hasle P. Making work environment auditable: A
address the safety issues in their laboratory activities. critical case study of certified occupational health and
• Reading safety data has become an integral part of safety management systems in Denmark. Safety Science.
scientific activities and every team devotes 5 to 10 minutes 2011;49(7):1022-9.
of every laboratory meeting to discussing safety issues that Pearse W, Gallagher C, Bluff L, editors. Occupational
arise. health & safety management systems: Proceedings of the
• Researchers are willing to discuss issues and participate First National Conference. 2001, Austin, Texas, USA.
in decision-making since their understanding of safety Shaw A, Blewitt V. Telling tales: OHS and organisational
issues has improved. culture. J Occup Health & Safety—Australia and New
• The school’s Safety Team was able to identify common Zealand. 1996;12(2):185-91.
issues and ensure that best practices were standardized and Singapore Attorney-General’s Chambers [Internet]. Singa-
shared throughout the school. pore: Government of Singapore; c2011 [cited 2013 Sin-
• Several poor/improper practices came to light involving gapore Statues Online Version: 1.2.18-10792. Available
chemical storage, disposal of cytotoxic drugs, and labeling from: http://statutes.agc.gov.sg
of cage cards in the animal facilities, for example, and were Transport Canada [Internet]. Ottawa: Government of Cana-
addressed jointly by the researchers and the Safety Team. da; c2006 [updated 2010 June 22; cited 2013 Safety man-
• There is a clearer understanding of roles and agement systems: Directive No. 31, Revision 2; [about 1
responsibilities in the laboratory. screen]. Available from: www.tc.gc.ca/eng/civilaviation/
• There is an improved understanding of the legal opssvs/directives-dir31rev2-338.htm.
requirements; researchers are comfortable in approaching Workplace Safety & Health Regulatory Framework, Singa-
the Safety Team when they feel that regulatory approvals pore Ministry of Manpower. Available from www.mom.
are needed. gov.sg/workplace-safety-health/wsh-regulatory-framework/
• There is a clearer understanding of legal requirements Pages/workplace-safety-health-act.aspx.
and active participation in feedback to the regulatory bodies.
• The school’s Safety Team is seen as facilitator and
administrative companion rather than as policing.