Pathfinder
Editor, Senior Moderator
Safety experts slam lax safety practices at CDC labs
Alison Young, USA TODAY 6:43 p.m. EDT March 19, 2015
A panel of safety experts appointed by the CDC to look at the agency's labs finds inadequate training, a lack of leadership and staff fearful of reporting accidents.
The Centers for Disease Control and Prevention, which recently had lab mishaps involving some of the world's most dangerous pathogens, does "inadequate" training, lacks leadership commitment toward safety and has a significant percentage of staff who are afraid to report accidents, according to the agency's own safety advisers.
"We are very concerned that the CDC is on the way to losing credibility," wrote the group of external biosafety experts, appointed by the agency as advisers in the wake of high-profile accidents with anthrax and bird flu last year. "The CDC must not see itself as 'special'. The internal controls and rules that the rest of the world works under also apply to CDC."
The CDC quietly posted the experts' report on its website this week. It is dated Jan. 13 – six months after CDC Director Tom Frieden testified before Congress that he'd taken significant steps to address safety issues. The Atlanta-based agency's high-security labs do wide-ranging public health experiments, including work with the Ebola virus to help combat the ongoing outbreaks in Africa, studies of deadly strains of influenza to help make better vaccines and examinations of anthrax to create better detection methods for bioterror agents.
"CDC concurs with these recommendations, has made progress towards implementing them, and will soon report on that progress," according to text posted with the report on the webpage.
...
http://www.usatoday.com/story/news/2...port/25031285/
---------------------------------------------------------------------------------------------------------------------------------------------------------------
CDC's 'inconsistent' lab practices threaten its credibility, report says
By Debra Goldschmidt, CNN
Updated 1:56 AM ET, Fri March 20, 2015
Atlanta (CNN)A report on lab safety at the U.S. Centers for Disease Control and Prevention put together by a committee of external experts calls the agency's commitment to safety "inconsistent and insufficient." The report, which was completed in January but posted on the agency's website this week, also says "laboratory safety training is inadequate."
The report was put together by an external group of 11 experts in biosafety, laboratory science and research. In the report, they say they are "very concerned that the CDC is on the way to losing credibility."
...
http://www.cnn.com/2015/03/19/health...s-credibility/
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations of the Advisory Committee to the Director
Concerning Laboratory Safety at CDC
13 January 2015
1. Observation: Leadership commitment toward safety has been inconsistent and
insufficient at multiple levels. Safety, including lab safety, is viewed by many as
something separate from and outside the primary missions of public health and
research. Safety is not integrated into strategic planning and is not currently part of the
CDC culture, enterprise-wide. Interviews and surveys demonstrated that many
employees neither understand the agency’s response to accidents nor how that
information is communicated to the larger agency community outside immediately
affected labs. Disturbingly, the negative responses peak among those individuals who
work at BSL3 and 4, especially among those holding a master’s degree. Individual
divisions, teams and lab groups have taken it upon themselves to implement safety
programs, but this is not done in a consistent manner, nor is it done across the CDC. A
clearly articulated CDC safety mission, vision or direction is lacking.
Recommendation: Establish a CDC brand and communicate, from the top down,
a “CDC Way” that is the performance of responsible science practiced in a
consistently safe manner. This should be an expectation, and all persons are
accountable. This should be a performance issue but personal negative
consequences should only be associated with failure to communicate incidents.
As part of this effort, better mechanisms should be established for sharing
information about safety incidents across CDC to promote transparency at all
levels.
Recommendation: Funding for laboratory safety programs and laboratory
safety training should be established from a central funding source and should
be considered a fundamental mission for the CDC. This responsibility should not
be outsourced to contract organizations who, ultimately, cannot be held
accountable.
Recommendation: Create a position for a biomedical scientist in the Director’s
office to lead this effort, which will also support the lab scientists.
2. Observation: Governance structures do not support maintaining a culture of shared
responsibility and accountability across Centers, nor the consistency of appropriate
safety practices. This is, in part, a result of the organizational complexity of the CDC.
For example, ESHCO and IBC/IACUC are outside the chain of command of
Centers/Divisions.
Recommendation: Establish governance structures that provide accountability
and oversight authority to a central entity for laboratory safety and compliance
committees (IBC/IACUC).
Recommendation: The central authority ultimately accountable for
performance of responsible laboratory science, laboratory safety and the
ESCHO, IBC and IACUC should sit organizationally at the level of the Office of the
Director.
3. Observation: Risk assessments of proposed research activities are either not being
done in a standardized manner or are not being done at all. Currently, the IBC only
reviews rDNA research.
Recommendation: Broaden the scope of the IBC to include work with
pathogenic microorganisms and biological toxins or establish a centralized,
standardized mechanism for consistent and thorough review and risk
assessment of proposed research activities.
Recommendation: Risk assessments should be performed for experimental
work being done at CDC. The benefits and risks of proposed experimental work
should be documented before the work is undertaken.
4. Observation: Laboratory safety training is inadequate. The organizational complexity
of the CDC has contributed to a fragmented, inconsistent approach to laboratory safety
training. The majority of training is now conducted on-line. Training is no longer under
the domain of ESHCO. The CDC does not have its own hands-on directly observed
centralized safety training program. Lab-specific training and competency
observations are conducted at program level and therefore, the quality is not
consistent. Observational competence occurs at the local lab level; however, except for
clinical labs, competency skills mapping and refresher training is not consistent.
Recommendation: Establish a standardized lab safety training curriculum
across CDC.
Recommendation: Establish standardized methods for competency skills
mapping and refresher training.
Recommendation: Establish a fellowship/internship program to train scientists
to serve as laboratory safety professionals who serve as liaisons between the
labs and ESHCO or other central lab safety entity.
Recommendation: Responsibilities and facilities for lab safety training should
be in-house.
5. Observation: The results of the Culture of Laboratory Safety survey indicate that a
significant percentage of CDC staff have concerns about experiencing negative
repercussions, either personally or more generally to the Agency, as a result of
reporting incidents involving exposures to pathogenic organisms or other hazardous
materials. Some staff members working in Select Agent laboratories fear regulatory or
other negative repercussions as a result of incident reporting. One example of this was
the case report of the CDC accident involving highly pathogenic H5N1 that became
public in June. Interviewed scientists all along the chain in that incident were
concerned that there were violations of the Select Agent rule. But there were no
mentions of people being similarly concerned with biosafety. Other interviews with
CDC staff also seemed to show a higher level of concern regarding SA violations than
biosafety violations. This finding suggests that at least in some laboratories,
biosecurity requirements are being given priority over biosafety.
Recommendation: Efforts to establish a culture of responsible science and
accountability are of critical importance. This culture of responsible science will
require prompt and accurate reporting of incidents or breaches in standard
protocol without fear of reprimand or punishment. (Not reporting should be
considered a breach of responsibility.) Reporting is important for facilitating
the analysis of incidents and the establishment of corrective actions to mitigate
repeat occurrences. Lessons learned from these activities should be shared with
the community.
Recommendation: In this culture of safety response, ensure that scientists
operating safe laboratories are recognized for their work. Some CDC scientists
feel that they have been doing their work safely and appropriately all along, but
they were swept up in corrective or punitive actions that should not have
applied to them.
6. Observation: ESHCO is undervalued and is seen by many staff scientists as an office
with focus on compliance. Additionally, it is perceived as an office with inadequate
expertise in lab safety. For this reason, scientists in some divisions have little or no
interaction with ESCHO. A related issue is that the resources dedicated to the
Occupational Medicine Program appear to be inadequate. It is critical that the
Occupational Medicine Program serve to support on-site research programs as well as
those abroad and that it become more integral to the health
monitoring/reporting/response network associated with laboratory safety.
Recommendation: Raise the stature of ESCHO in the CDC organization by
staffing it with scientists with professional qualifications in research and/or
laboratory safety as well as an understanding of requirements for compliance.
Recommendation: Establish a fellowship/internship program to train scientists
to serve as laboratory safety professionals. This training program should
involve interns or fellows in the development and management of lab safety
programs at the CDC as a central part of their training and professional
development.
Recommendation: Develop a division liaison program, where each division
identifies individuals who can represent their needs to a centralized EHSCO
committee.
Recommendation: Expand the scope and capabilities of the Occupational
Medicine Program to facilitate a more robust and active effort in monitoring
employee health and in responding to laboratory incidents.
7. Observation: CDC is an incredibly capable organization and its value in promoting the
health of our society cannot be lost. We are very concerned that the CDC is on the way
to losing credibility. The CDC must not see itself as "special". The internal controls and
rules that the rest of the world works under also apply to CDC. There is need for a CDC
systematic approach characterized by high-level leadership support and
intervention. Accountability, personal accountability not only our own actions, but the
actions of others is essential. While human error is the fundamental cause of events
like those challenging the CDC in recent months, it is also the reason why multiple
layers of checks and balances and redundancy of controls must be built into the
process of oversight and management system.
Recommendation: The ELSW strongly encourages the CDC to track and to
report on its progress in establishing programmatic elements and processes
recommended in this ELSW report in some formal way (perhaps at the 3 month,
6 month and 12 month mark) or to provide an explanation of why it was
decided to not to pursue specific recommendations. This progress doesn't
necessarily need to be reported back to the ELSW - it could be back to the new
Laboratory Safety Director once hired or to the Internal Laboratory Safety
Working Group or some other entity - though there would be logic in briefing in
back to the ELSW.
Recommendation: The ELSW recommends that CDC laboratories go through an
external review and accreditation process for all labs. The College of American
Pathologists (CAP) could do this for the clinical labs. The CDC should pursue a
similar accreditation for research labs, perhaps by commissioning this
accreditation through the American Biological Safety Association (ABSAhttp://www.absa.org/aiahclap.html).
http://www.cdc.gov/about/pdf/lab-saf...2015-01-16.pdf
Alison Young, USA TODAY 6:43 p.m. EDT March 19, 2015
A panel of safety experts appointed by the CDC to look at the agency's labs finds inadequate training, a lack of leadership and staff fearful of reporting accidents.
The Centers for Disease Control and Prevention, which recently had lab mishaps involving some of the world's most dangerous pathogens, does "inadequate" training, lacks leadership commitment toward safety and has a significant percentage of staff who are afraid to report accidents, according to the agency's own safety advisers.
"We are very concerned that the CDC is on the way to losing credibility," wrote the group of external biosafety experts, appointed by the agency as advisers in the wake of high-profile accidents with anthrax and bird flu last year. "The CDC must not see itself as 'special'. The internal controls and rules that the rest of the world works under also apply to CDC."
The CDC quietly posted the experts' report on its website this week. It is dated Jan. 13 – six months after CDC Director Tom Frieden testified before Congress that he'd taken significant steps to address safety issues. The Atlanta-based agency's high-security labs do wide-ranging public health experiments, including work with the Ebola virus to help combat the ongoing outbreaks in Africa, studies of deadly strains of influenza to help make better vaccines and examinations of anthrax to create better detection methods for bioterror agents.
"CDC concurs with these recommendations, has made progress towards implementing them, and will soon report on that progress," according to text posted with the report on the webpage.
...
http://www.usatoday.com/story/news/2...port/25031285/
---------------------------------------------------------------------------------------------------------------------------------------------------------------
CDC's 'inconsistent' lab practices threaten its credibility, report says
By Debra Goldschmidt, CNN
Updated 1:56 AM ET, Fri March 20, 2015
Atlanta (CNN)A report on lab safety at the U.S. Centers for Disease Control and Prevention put together by a committee of external experts calls the agency's commitment to safety "inconsistent and insufficient." The report, which was completed in January but posted on the agency's website this week, also says "laboratory safety training is inadequate."
The report was put together by an external group of 11 experts in biosafety, laboratory science and research. In the report, they say they are "very concerned that the CDC is on the way to losing credibility."
...
http://www.cnn.com/2015/03/19/health...s-credibility/
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations of the Advisory Committee to the Director
Concerning Laboratory Safety at CDC
13 January 2015
1. Observation: Leadership commitment toward safety has been inconsistent and
insufficient at multiple levels. Safety, including lab safety, is viewed by many as
something separate from and outside the primary missions of public health and
research. Safety is not integrated into strategic planning and is not currently part of the
CDC culture, enterprise-wide. Interviews and surveys demonstrated that many
employees neither understand the agency’s response to accidents nor how that
information is communicated to the larger agency community outside immediately
affected labs. Disturbingly, the negative responses peak among those individuals who
work at BSL3 and 4, especially among those holding a master’s degree. Individual
divisions, teams and lab groups have taken it upon themselves to implement safety
programs, but this is not done in a consistent manner, nor is it done across the CDC. A
clearly articulated CDC safety mission, vision or direction is lacking.
Recommendation: Establish a CDC brand and communicate, from the top down,
a “CDC Way” that is the performance of responsible science practiced in a
consistently safe manner. This should be an expectation, and all persons are
accountable. This should be a performance issue but personal negative
consequences should only be associated with failure to communicate incidents.
As part of this effort, better mechanisms should be established for sharing
information about safety incidents across CDC to promote transparency at all
levels.
Recommendation: Funding for laboratory safety programs and laboratory
safety training should be established from a central funding source and should
be considered a fundamental mission for the CDC. This responsibility should not
be outsourced to contract organizations who, ultimately, cannot be held
accountable.
Recommendation: Create a position for a biomedical scientist in the Director’s
office to lead this effort, which will also support the lab scientists.
2. Observation: Governance structures do not support maintaining a culture of shared
responsibility and accountability across Centers, nor the consistency of appropriate
safety practices. This is, in part, a result of the organizational complexity of the CDC.
For example, ESHCO and IBC/IACUC are outside the chain of command of
Centers/Divisions.
Recommendation: Establish governance structures that provide accountability
and oversight authority to a central entity for laboratory safety and compliance
committees (IBC/IACUC).
Recommendation: The central authority ultimately accountable for
performance of responsible laboratory science, laboratory safety and the
ESCHO, IBC and IACUC should sit organizationally at the level of the Office of the
Director.
3. Observation: Risk assessments of proposed research activities are either not being
done in a standardized manner or are not being done at all. Currently, the IBC only
reviews rDNA research.
Recommendation: Broaden the scope of the IBC to include work with
pathogenic microorganisms and biological toxins or establish a centralized,
standardized mechanism for consistent and thorough review and risk
assessment of proposed research activities.
Recommendation: Risk assessments should be performed for experimental
work being done at CDC. The benefits and risks of proposed experimental work
should be documented before the work is undertaken.
4. Observation: Laboratory safety training is inadequate. The organizational complexity
of the CDC has contributed to a fragmented, inconsistent approach to laboratory safety
training. The majority of training is now conducted on-line. Training is no longer under
the domain of ESHCO. The CDC does not have its own hands-on directly observed
centralized safety training program. Lab-specific training and competency
observations are conducted at program level and therefore, the quality is not
consistent. Observational competence occurs at the local lab level; however, except for
clinical labs, competency skills mapping and refresher training is not consistent.
Recommendation: Establish a standardized lab safety training curriculum
across CDC.
Recommendation: Establish standardized methods for competency skills
mapping and refresher training.
Recommendation: Establish a fellowship/internship program to train scientists
to serve as laboratory safety professionals who serve as liaisons between the
labs and ESHCO or other central lab safety entity.
Recommendation: Responsibilities and facilities for lab safety training should
be in-house.
5. Observation: The results of the Culture of Laboratory Safety survey indicate that a
significant percentage of CDC staff have concerns about experiencing negative
repercussions, either personally or more generally to the Agency, as a result of
reporting incidents involving exposures to pathogenic organisms or other hazardous
materials. Some staff members working in Select Agent laboratories fear regulatory or
other negative repercussions as a result of incident reporting. One example of this was
the case report of the CDC accident involving highly pathogenic H5N1 that became
public in June. Interviewed scientists all along the chain in that incident were
concerned that there were violations of the Select Agent rule. But there were no
mentions of people being similarly concerned with biosafety. Other interviews with
CDC staff also seemed to show a higher level of concern regarding SA violations than
biosafety violations. This finding suggests that at least in some laboratories,
biosecurity requirements are being given priority over biosafety.
Recommendation: Efforts to establish a culture of responsible science and
accountability are of critical importance. This culture of responsible science will
require prompt and accurate reporting of incidents or breaches in standard
protocol without fear of reprimand or punishment. (Not reporting should be
considered a breach of responsibility.) Reporting is important for facilitating
the analysis of incidents and the establishment of corrective actions to mitigate
repeat occurrences. Lessons learned from these activities should be shared with
the community.
Recommendation: In this culture of safety response, ensure that scientists
operating safe laboratories are recognized for their work. Some CDC scientists
feel that they have been doing their work safely and appropriately all along, but
they were swept up in corrective or punitive actions that should not have
applied to them.
6. Observation: ESHCO is undervalued and is seen by many staff scientists as an office
with focus on compliance. Additionally, it is perceived as an office with inadequate
expertise in lab safety. For this reason, scientists in some divisions have little or no
interaction with ESCHO. A related issue is that the resources dedicated to the
Occupational Medicine Program appear to be inadequate. It is critical that the
Occupational Medicine Program serve to support on-site research programs as well as
those abroad and that it become more integral to the health
monitoring/reporting/response network associated with laboratory safety.
Recommendation: Raise the stature of ESCHO in the CDC organization by
staffing it with scientists with professional qualifications in research and/or
laboratory safety as well as an understanding of requirements for compliance.
Recommendation: Establish a fellowship/internship program to train scientists
to serve as laboratory safety professionals. This training program should
involve interns or fellows in the development and management of lab safety
programs at the CDC as a central part of their training and professional
development.
Recommendation: Develop a division liaison program, where each division
identifies individuals who can represent their needs to a centralized EHSCO
committee.
Recommendation: Expand the scope and capabilities of the Occupational
Medicine Program to facilitate a more robust and active effort in monitoring
employee health and in responding to laboratory incidents.
7. Observation: CDC is an incredibly capable organization and its value in promoting the
health of our society cannot be lost. We are very concerned that the CDC is on the way
to losing credibility. The CDC must not see itself as "special". The internal controls and
rules that the rest of the world works under also apply to CDC. There is need for a CDC
systematic approach characterized by high-level leadership support and
intervention. Accountability, personal accountability not only our own actions, but the
actions of others is essential. While human error is the fundamental cause of events
like those challenging the CDC in recent months, it is also the reason why multiple
layers of checks and balances and redundancy of controls must be built into the
process of oversight and management system.
Recommendation: The ELSW strongly encourages the CDC to track and to
report on its progress in establishing programmatic elements and processes
recommended in this ELSW report in some formal way (perhaps at the 3 month,
6 month and 12 month mark) or to provide an explanation of why it was
decided to not to pursue specific recommendations. This progress doesn't
necessarily need to be reported back to the ELSW - it could be back to the new
Laboratory Safety Director once hired or to the Internal Laboratory Safety
Working Group or some other entity - though there would be logic in briefing in
back to the ELSW.
Recommendation: The ELSW recommends that CDC laboratories go through an
external review and accreditation process for all labs. The College of American
Pathologists (CAP) could do this for the clinical labs. The CDC should pursue a
similar accreditation for research labs, perhaps by commissioning this
accreditation through the American Biological Safety Association (ABSAhttp://www.absa.org/aiahclap.html).
http://www.cdc.gov/about/pdf/lab-saf...2015-01-16.pdf