Tales from DC: ASSE at OSHA Infectious Disease Stakeholder Meeting
On Friday, July 29, Joe Klancher represented ASSE at OSHA’s Stakeholder Meeting on Occupational Exposure to Infectious Disease held at the Department of Labor in Washington, DC. Joe is the Administrator of ASSE’s Healthcare Practice Specialty. Joe participated in the morning session of the two-part meeting held July 29. The meeting represented the first step in a process that could result in OSHA proposing a standard on the issue. Materials related to the meeting and the rulemaking, including a list of participants, will able to be found in the rulemaking docket at http://www.regulations.gov/#!docketDetail;dct=FR+PR+N+O+SR;rpp=10;po=0;D=OSHA-2010-0003. In preparation for the meeting, ASSE talking points were developed through the participation of Joe and other interested Healthcare Practice Specialty members. Those talking points – which do not represent an ASSE position on a standard – are based on questions posed by OSHA in the notice for this meeting and can be found below.
In a conference room, participants sat in a large open square with OSHA standards staff, including Dorothy Dougherty, Director of Standards, sitting at the closed end. A staff moderator portioned the meeting along four areas of inquiry, noted below, and each participant who wanted to comment or ask a question in each area were given an opportunity to do so.
In general, the conversation evolved generally into a polite for-and-against discussion between those representing labor and public health concerns and those representing the health care industry, including the American Hospital Association. It is difficult to see from the conversation that OSHA will not be pursuing an infectious disease standard.
In introductory comments, OSHA staff stated that, in its current thinking about a possible standard, OSHA was looking towards a program standard, meaning one that would require employers to “plan, train and do.” They also have in mind a vertical standard applicable only to the healthcare industry. And they are concerned with airborne droplets like MRSA and not diseases already covered by the blood borne pathogen standard. They are looking for guidance toward the Healthcare Infection Control Practices Advisory Committee (HICPAC) recommendations on the practice of health care infection control, strategies for surveillance and prevention and control of health care (http://www.cdc.gov/hicpac/).
The areas of discussion were
Scope, Applicability, Costs and Availability
OSHA staff indicated they are looking towards a split scope for a possible standard that would address both workers in direct patient care and other workers. A standard would apply to infectious agents where medical care is needed. OSHA does not expect to have a list of diseases so as not to lock the standard in time. A standard would not supersede other OSHA standards. There would be no cost to employees. Training would occur during working hours.
The discussion that resulted was an attempt, at first, by participants to pin OSHA down on specifics of scope and applicability. Participants asked if research facilities with exposure to infectious diseases would be covered, how far the standard would go in covering jails, especially small town and county jails and their laundry facilities, veterinary facilities, funeral homes, dental and long term care facilities. Such research facilities and dental offices would be covered and vet facilities would not, but staff urged participants to tell them the difficulties and challenges and other concerns of scope and applicability so they can better make appropriate determinations in the other kinds of facilities.
Other issues that were raised included
- How to define a patient especially in community settings.
- The problem of meeting the standard in schools at a time when school nurses are quickly disappearing was mentioned.
- Urging OSHA to provide guidance on TB, for which they should rely on the CDC.
- The problem that, if hazard assessment is required, some organizations, especially smaller organizations, will not be able to do it well.
- Urging OSHA to include in its cost/benefit analysis public entities since in 26 states that have state plans public entities would be covered under a standard.
- Urging OSHA to look to the cost/benefit experience by California under its recent Aerosol Transmissible Diseases (ATD) standard http://www.dir.ca.gov/title8/5199.html).
A representative from the American Hospital Association stated that hospitals were already required to protect workers from infectious disease by the Centers for Medicare and Medicaid Services (CMS) (https://www.cms.gov/), accreditation requirements and state agencies and stated that OSHA should demonstrate why a standard is needed if what already exists is working.
WICP and Methods of Compliance
The meeting then addressed worker infection control plans (WICP) and methods of compliance.
OSHA staff indicated they are thinking along the lines of a standard that would require all employers with workers to write a plan with responsible people managing it. They envision that a list of standard operating procedures would be the plan. It would require an infectious agent hazard analysis, prompt identification of hazards, communication of hazards with signage, labeling and training, medical surveillance and exposure identification. A WICP would have to be accessible to workers and be updated annually with worker input solicited. OSHA will consider current regulations and guidelines. A hierarchy of controls will be required. Current technologies will not be part of standard, giving it applicability beyond current knowledge. Compliance methods will require employers to “plan, train and do and require employers “just to do what you say you are going to do.”
Comments and discussion that resulted included
- Urging OSHA simply to adopt the European Biosafety Assocaition Laboratory Biorisk Management Standard CWA 15793:2008 (http://ebsaweb.eu/Projects+_+Activities/Laboratory+Biorisk+Management+Standard-p-187.html).
- Industry representatives’ concern that OSHA’s description of its intent reflects nothing more than what the industry is already doing.
- Concern over the impact on small businesses.
- Urging OSHA to require that employees be involved throughout the process in developing a plan and not simply in reviewing a plan.
- The idea that OSHA should provide guidelines and focus on helping small businesses.
- Urging OSHA to harmonize emergency response plans with a standard.
- OSHA staff’s own question that, if industry is already doing this, what would the additional cost to them bet? Answers to that question included that facilities need a lot of flexibility to protect workers and a standard would take that flexibility away; that there are direct and opportunity costs and that OSHA should demonstrate that what hospitals are doing now is not working and that this effort is inconsistent with Obama’s recent comments on lessening the burden or regulation; and that a standard would make current standards more effective.
- That a recent study of 1500 facilities, 30 major hospitals demonstrated that all had infectious disease programs.
- A standard should consider a public health response and make sure the importance of the intersection with public health departments in dealing with infectious diseases is addressed.
- That the further you get away from hospitals, the less rigor exists in infectious disease control and that current guidelines do not address the latest data on infectious diseases.
- That there is a difference between known and unknown diseases and that should be reflected in a standard.
- That a lot of small offices in the health care industry do not know what OSHA means.
Medical Screening, Surveillance and Vaccinations
OSHA staff indicated the current discussion about a possible standard involved requiring employers to provide medical screening, surveillance and vaccinations. Vaccine training would be required. Handling exposure incidents would not require these procedures. Medical removal would be required. These requirements would not apply to the common cold or flu.
Among the issues discussed were
- In jails, there often is no proof of immunity available from employees even with due diligence and medical removal is costly and prohibitive and threatens public safety in small facilities especially with already tight staff levels.
- Vulnerable workers such as pregnant women should be addressed.
- The need for declination statements with regard to employees not allowing themselves to be vaccinated was discussed. Later, OSHA asked how to make sure such statements could be use appropriately and not simply to avoid vaccinations. In responses, the statement was made that research is equivocal on the subject and that it should be as effective as under the blood borne pathogen standard.
- Urging OSHA not to include language limiting employers ability to determine employment so that employers can fire someone for inappropriately not adhering to vaccination policies.
- Vaccines should be mandated of employees since some do not want them.
- Labor representation stated that OSHA did not want to include such provisions since every case protecting a worker’s right not to have a vaccine has been won in courts or under EEOC and HIPPA.
- OSHA needs to consider that many employees do not have sick leave when it considers the impact of mandating removal.
Communication of Hazards and Recordkeeping
OSHA staff indicated that their discussion on a possible standard aimed at requiring all appropriate signage and that medical records, exposure incident records, WICP review records and be made available to workers and their representatives.
The discussion that followed included
- Funeral directors’ statement that they are exempt from 300 log reporting and should also be exempt from reporting requirements of this standard.
- That exposure needs to be defined carefully since there are thousands of diseases and that simply being in a room with an infected individual does not mean there is an exposure.
- Training for workers on vaccinations and their effectiveness is needed.
- Urging OSHA to consider that small companies have extreme difficulties in getting needed paperwork from health care providers. Others expressed this concern also.
- Training on how to report is needed.
- Underreporting is a difficult problem among Hispanic workers so community-based training is important.
- OSHA should look to new methods of getting workers to report.
- Employers should be required to measure their continuous improvement.
- OSHA should be required in the standard to demonstrate the standard’s effectiveness going forward.
- OSHA’s ability to enforce this standard should not be the primary consideration. The primary consideration for the standard should be to provide training and lower employer exposures.
ASSE’s Talking Points in Preparation for the Meeting –
Joe Klancher will be representing ASSE and the Healthcare Practice Specialty at the July 29 stakeholders meeting marking the beginning of OSHA’s effort to promulgate a possible standard on the subject. The notice for the meeting can be found at http://www.gpo.gov/fdsys/pkg/FR-2011-07-05/html/2011-16742.htm.
ASSE has not taken a position on this rulemaking or a possible standard.
The following are talking points for the meeting assembled with input from participating members of the Healthcare Practice Specialty in a general conversation about the questions OSHA has proposed below in its notice for this meeting.
- (ASSE question) is there a demonstrable need for a standard? Or, would a standard help you do your work?
No position has been taken. A standard has not yet been proposed. From ASSE members’ view, whether there is a need for a standard depends on the organization and facility. Where most ASSE members work, practices are generally good and are adequately encouraged through existing CDC and NIH guidelines and through facilities’ efforts to meet Centers for Medicare & Medicaid Services (CMS), The Joint Commission and other similar accreditation requirements. However, our members do witness organizations that must be encouraged to do more than what is absolutely required of them, and no doubt organizations exist that fail to address worker protections in this area. Also, CMS generally could do a better job of making sure facilities comply with CDC’s guidelines. For these reasons, an appropriate standard may help encourage better worker protections.
It also should be noted that many organizations are focused on accreditation requirements and have little understanding of the need to meet OSHA standards. A standard would certainly make that need clear.
- Whether and to what extent an OSHA standard on occupational exposure to infectious diseases should apply in settings where workers provide direct patient care, as well as, settings where workers have occupational exposure even though they don’t provide direct patient care. Whether and to what extent there are any other settings where an OSHA standard should apply.
If a standard is needed, a standard should do its best to cover all workers. Scope should be driven by exposure. However, much depends on a definition of “direct patient care.” What is or is not direct patient care is difficult to define in a healthcare setting. OSHA will need to work carefully with its stakeholders in healthcare in writing a definition.
A similarly important question is why a standard would be limited to infectious diseases. If the aim is to address pandemic flu and other similar risks, then OSHA should consider including measures that address source risks in its jurisdiction like poultry handlers and agricultural workers. If the purpose is to protect healthcare workers, then limiting this standard to infectious diseases may not be addressing the most significant risks in healthcare today. The industry is already working diligently to address more effectively worker protections against risks from drug and chemical exposures. While the proposed standard focuses on infectious diseases, which is very important, there are other associated exposure risks for healthcare employees such as formaldehyde, xylene, glutaraldehyde, ethylene oxide, and waste anesthetic gases. Additionally, too often infection control practitioners and even some hospital safety officers are not able to clearly define and prioritize infection control risks vs. industrial hygiene exposure risks. A standard should help clarify and not make these responsibilities more difficult.
- The advantages and disadvantages of using a program standard to limit occupational exposure to infectious diseases, and the advantages and disadvantages of taking other approaches to organizing a prospective standard.
If a standard is needed, a program standard is the appropriate approach, mirroring what safety and health professionals do to protect workers in healthcare setting or any other workplace. The worker infection control plan (WICP) outlined in Question provides an outline of what an effective program would entail. Done in a way that encourages risk-based management of safety and health, such an approach has the ability to encourage an organization to develop a safety culture that seeks levels of protections beyond compliance.
ASSE is curious, however, how the need for a specific program standard in this area would be affected by the promulgation of an OSHA injury and illness prevention program (I2P2) standard, as this would likely address similar program issues in healthcare settings.
- Whether and to what extent an OSHA standard should require each employer to develop a written worker infection control plan (WICP) that documents how the employer will implement the infection control measures it will use to protect the workers in its facility. Some of the elements that might be appropriate to include in such a worker infection control plan are: Designation of the plan administrator responsible for WICP implementation and oversight; designation of the individual(s) responsible for conducting infectious agent hazard analyses in the work setting; and written standard operating procedures (SOPs) to minimize or prevent exposure to infectious agents (e.g., SOPs for early identification of potentially infectious individuals and for implementation of standard and transmission-based precautions).
Some accreditation bodies currently require an infection control written program.
- Whether and to what extent SOP development should be based upon consideration of applicable regulations/guidance issued by the Centers for Disease Control and Prevention, the National Institutes of Health, and other authoritative agencies/organizations.
If a standard is necessary, OSHA should construct one that is as consistent as possible with widely accepted guidelines already in use in the industry, including CDC and NIH guidelines as well as the standards CMS, the Joint Commission and other accreditation bodies use. As appropriate, incorporating by reference widely standards widely accepted throughout the industry may be appropriate. In general, consistency between OSHA standards and accepted safety and health practices helps avoid confusion and helps organizations achieve better worker protections. Also, lessening regulatory burdens, as this Administration has recently been working to achieve, should play an important role in OSHA’s deliberations over this standard.
ASSE urges OSHA to work closely with CMS, The Joint Commission and other accreditation bodies to understand fully the current expectations of accrediting bodies regarding occupational safety and health.
OSHA should also take into consideration that California has an Aerosol Transmissible Diseases (ATD) Standard, adopted by Cal-OSHA in May 2009. So far ASSE is not aware that members have experienced difficulties in helping their employers meet the standard, though enforcement of the standard is new.
- Whether and to what extent an OSHA standard should require each employer to implement its WICP through a section addressing methods of compliance. OSHA envisions that this section would require, among other control measures, that an employer conduct an infectious agent hazard analysis, follow appropriate SOPs, institute appropriate engineering, work practice, and administrative controls, provide and ensure the use of appropriate personal protective equipment, clean and decontaminate the worksite, and conduct prompt exposure investigations.
A section that would address methods of compliance would be helpful, if a standard is promulgated. One benefit would be to help OSHA inspectors understand the issues they are dealing with in an inspection of a healthcare facility. Now, our members too often experience inspectors who are not adequately trained to evaluate risks in health care settings and can only focus on risks they’ve already experienced in other workplace settings. Such a section would help focus their efforts.
However, this question raises the possibility that OSHA will require audits of internal procedures similar to an ISO audit. Is that OSHA’s intent? If so, our members question OSHA’s ability to do such an audit with current resources. Clearly, training of inspectors will have to be extensive. Also, in healthcare settings, members warn that standard operating procedures (SOPs) lack common definition. For example, while a clinical lab may have its own understanding of the term, a research area of a facility may rely on lab notebooks. The term needs to be defined in context of OSHA’s oversight of a facility.
- Whether and to what extent an OSHA standard should require each employer to make available routine medical screening and surveillance, vaccinations to prevent infection, and post-exposure evaluation and follow-up to all workers who have been exposed to a suspected or confirmed source of an infectious agent(s) without the benefit of appropriate infection control measures.
ASSE members caution that requiring such invasive procedures from workers is difficult. The ability of OSHA to require organizations to carry out such activities will depend on the definition of terms like “screening and surveillance.” Whether government has the authority to require vaccinations and what may be seen as enforced medical procedures entails a careful balancing of constitutionally protected rights of individuals and may interfere with rights negotiated between the employer and labor organizations. It could be that OSHA goes a bridge too far in trying to require what amounts to public health measures as opposed to focusing on achievable workplace safety and health oversight. If employers take appropriate steps to protect workers, invasive screening and surveillance should not be necessarily enforced by OSHA. It could be that OSHA’s limited resources in oversight are better well spent on helping ensure protections in the first place.
- Whether and to what extent an OSHA standard should contain signage, labeling, and worker training requirements to ensure the effectiveness of infection control measures.
Appropriate signage and labeling will be needed, as applicable to the setting. Worker training may be the most important element for a standard to succeed, and healthcare facilities are generally well prepared to do appropriate training.
- Whether and to what extent an OSHA standard should require the employer to establish and maintain medical records, exposure incident records, and records of reviews of its worker infection control program, and whether and to what extent an OSHA standard should contain other recordkeeping requirements.
Health care facilities already perform this kind of recordkeeping. The requirements are similar to those under the Bloodborne Pathogen standard. Nevertheless, OSHA should take care not to add unnecessary paperwork not directly related to worker protection if the need for a standard has been demonstrated.
- The economic impacts of a prospective standard.
Given that health care facilities already are required to protect their workers under accreditation standards, if a standard does not differ substantially from current requirements unnecessarily, the theoretical economic impact should be minimal.
- Whether and to what extent OSHA should take alternative approaches to rulemaking to improve adherence to current infection control guidelines issued by the Centers for Disease Control and Prevention, the National Institutes of Health, and other authoritative agencies/organizations.
A positive approach to this standard may be through negotiated rulemaking. Much consensus already exists in the industry and establishing a process that encourages the involvement of all stakeholders may encourage quick resolution of the peripheral issues that will arise as this rulemaking progresses.
- Additional topics as time permits.
One significant question ASSE members ask is, how will the success of this standard be measured? Our members encourage OSHA to consideration including in the standard a means of measuring OSHA’s expectations for improving workplace protections. No doubt, including that in a standard is difficult, especially for infectious diseases in health care settings. Injuries and fatalities are much easier to measure. Nevertheless, it would benefit OSHA as well as industry if some thought could go into determining how to measure this standard’s effectiveness in the future.