By Kelly M. Pyrek
Editor's note: This article originally appeared as part of the 2012 Regulatory Update in the January 2012 print issue of ICT. To access a slide show presenting the highlights of the 2012 Regulatory Update, CLICK HERE.
The Occupational Safety and Health Administration (OSHA) is continuing to examine occupational exposure to infectious agents in healthcare settings, and members of the infection prevention and healthcare epidemiology communities are weighing in with their perspectives as the federal agency gathers data.
OSHA says it is interested in strategies currently being deployed in healthcare settings to mitigate the risk of work-acquired infectious diseases. As such, OSHA is collecting information and data on the facilities and the tasks potentially exposing workers to this risk; successful employee infection control programs; control methodologies being utilized (including engineering, work practice, and administrative controls and personal protective equipment); medical surveillance programs; and training. It solicited public comment and also held stakeholder meetings to gather additional insights. Last summer, OSHA solicited public comment and the agency will use the information received to determine what action, if any, the agency may take to further limit the spread of occupationally-acquired infectious diseases in healthcare settings. More than 200 comments were submitted, many from healthcare professionals at hospitals and healthcare systems, departments of health, associations serving the infection prevention community, and members of industry.
"OSHA is exploring the possible development of a proposed rule to protect workers from occupational exposure to infectious agents in healthcare settings where direct patient care is provided and other settings where workers perform tasks with occupational exposure," explains Kimberly Tucker in the Office of Communications at OSHA. "The July 29, 2011 meetings were designed as an open discussion so that participants could share with OSHA not only regulatory options and concerns but also alternative approaches. The stakeholder meetings were just one of many sources of information that the agency is using to inform its decision on how to proceed on the issue of infectious diseases. OSHA received substantial input from stakeholders during the request for information, all of which is publicly available in the docket. OSHA is also continuing to review and evaluate the scientific literature which contains a great deal of information on adherence in infection control guidelines."
One action that OSHA is considering is the development of a program standard to control workers exposure to infectious agents in settings, either where workers provide direct patient care or where workers perform tasks other than direct patient care which also have occupational exposure. These other tasks might include such tasks as providing patient support services (e.g., housekeeping, food delivery, facility maintenance); handling, transporting or wastes (e.g., laundering healthcare linens, transporting medical specimens, disposing of medical waste, reprocessing medical equipment); maintaining, servicing or repairing medical equipment that is contaminated with infectious agents; conducting autopsies (e.g., in medical examiners' offices); performing mortuary services; and performing tasks in laboratories (e.g., clinical, biomedical research, production laboratories) that result in occupational exposure.
"All workplaces must be safe workplaces," says David Michaels, PhD, MPH, assistant secretary of labor. "We know that workers in healthcare and related facilities may be exposed to infectious agents, and they deserve to be protected. Preventing infectious disease among workers also will reduce exposure to their family members and to patients." Michaels is tasked with making the final recommendation on a potential standard and as of press time in late November, no decision has been made.
The July 29 stakeholder meetings were conducted as group discussions on views, concerns and issues surrounding the hazards of occupational exposure to infectious agents and how best to control them. At the meeting, Andrew Levinson, director of the OSHA Office of Biological Hazards, described OSHA's traditional approach to a program standard, which follows the principle of "plan, train, do." The planning element of this approach details the hazards and provides a framework that employers use to execute the training and implementation elements of a program standard. This approach allows for a large amount of flexibility -- if something changes, employers can just adjust the plan and retrain their workers. OSHA is also considering a vertical approach for a potential standard. Vertical standards apply to a particular group of workers where a hazard exists, while horizontal standards apply to any worker in any industry where the hazard exists. Vertical standards emphasize scope, and take into account the hazard and the specific workers and settings.
The potential standard that OSHA is considering would encompass all exposure pathways (e.g., contact, droplet, airborne), but would only cover contact transmissions that are not covered by the bloodborne pathogens (BBP) standard. For example, it would cover methicillin-resistant Staphylococcus aureus (MRSA) but not hepatitis B. In developing such a standard, OSHA would review the Healthcare Infection Control Practices Advisory Committee (HICPAC)'s guidelines and extract programmatic and administrative elements for incorporation. Levinson emphasized that the meeting should focus on four elements: validation of metior elements, blind spots or errors in major elements, areas with unintended consequences, and issues associated with non-hospital settings (e.g., mortuary, ambulatory, long-term care, home health, laboratories).
Essentially, OSHA representatives sought specific information on the potential development of a program standard that would include the following sections: the scope, application, costs, and availability; Worker Infection Control Plans (WICPs) and methods of compliance; medical screening, surveillance, and vaccination; and communication of hazards and recordkeeping.
The meeting discussions focused on such major issues as:
- 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.
- 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.
- 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 WICP 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). According to OSHA, in settings where direct patient care is provided, SOPs would likely also include: patient scheduling and intake; standard precautions; transmission-based precautions (contact, droplet, airborne); patient placement and transport; and medical surge procedures.
- 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.
- 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.
- 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.
- Whether and to what extent an OSHA standard should contain signage, labeling, and worker training requirements to ensure the effectiveness of infection control measures.
- 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.
- The economic impacts of a prospective standard.
- 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.
The Scope of a Potential Standard
Thomas Nerad of OSHA described the scope, application, costs and availability sections of the potential program standard OSHA is considering. Nerad emphasized that the program standard OSHA is considering would allow for flexibility, as there are continually emerging infectious agents. In the potential standard, OSHA would not provide a list of infectious agents and employers would be responsible for determining the infectious agents of concern at their workplace.
Nerad said the potential standard defines the term "occupational exposure" as reasonably anticipated contact with suspected or confirmed sources of infectious agents resulting from a worker's performance of his/her duties. Such exposures could occur through the contact, droplet, and airborne routes of transmission. The potential standard also defines the term "infectious agent" as a biological agent capable of causing adverse health effects sufficient to require medical care. The scope of the potential standard OSHA is considering would include occupational exposure to infectious agents in two circumstances: 1) during provision of direct patient care, for example, by doctors, nurses, paramedics, and emergency responders in settings such as hospitals, clinics and medical facilities embedded in non-medical settings (e.g., schools, prisons); and 2) during the performance of other covered tasks (both on-site and off-site) with occupational exposure to infectious agents, including handling of infectious items in laboratories and healthcare laundries, and during maintenance and reprocessing of contaminated equipment.
The potential standard OSHA is considering would not replace existing regulations (e.g., the BBP standard would remain in effect). Workers would not incur any costs related to implementation of the potential standard's requirements. Further, employers would be required to make all medical evaluations and procedures available to the worker at reasonable times and locations, and to provide training during work hours.
Regarding the need for an infectious agent standard, the primary stakeholder concern was whether OSHA needs to develop and implement a new standard specific to infectious agents. Some stakeholders urged OSHA to consider that many industries are already heavily regulated in this area, most notably the hospital industry, which must already implement regulations by the Centers for Medicare & Medicaid Services (CMS) and state agencies. Further, industries, dental offices, blood centers, and similar environments are already covered under the BBP standard. By adhering to the Centers for Disease Control and Prevention (CDC) guidelines, industries are already required to address BBP and airborne transmissions in ways that go beyond potential OSHA requirements. These stakeholders requested that OSHA demonstrate why additional regulation is necessary given that these occupation scenarios do not involve a higher rate of infection compared to the general population. They felt that, even with OSHA's promise of flexibility in the plan, implementation would be burdensome on facilities, with no added value.
Other stakeholders commented that a new standard is still necessary for those settings that are not as highly regulated. Further, consistency between guidance in multiple agencies (CDC, CMS) and private organizations is essential, and OSHA needs to be a leader because other organizations are not focused solely on protecting workers. OSHA needs to develop this rule, they said, within the context of worker protection.
Amanda Edens, deputy director of the Directorate of Standards and Guidance, noted that OSHA has not decided whether a proposed standard will be developed. Unions petitioned OSHA to explore this issue in response to California OSHA's standard and the H1N1 pandemic. Edens emphasized that a new standard is one of several ways for OSHA to address the petition. Stakeholders recommended that OSHA refer to existing guidance for assistance if it develops a new standard. For example, CalOSHA's Aerosol Transmissible Disease Standard would be a useful model.
Stakeholders expressed concern over a new standard not addressing specific agents; they said this approach is too broad and would cause complications for employers. Employers may not have the proper resources to identify the infectious agents of concern specific to their facility. Stakeholders also expressed the thought that OSHA should consider the implications of exposure length (one continuous shift versus a single incident) if it develops a new standard (e.g., exposure length has implications for TB and MRSA).
Stakeholders also had concerns about specific disease considerations. For example, some stakeholders recommended that OSHA consider developing a specific standard for tuberculosis, referring to CDC and the Mayo Clinic for guidance). Some individuals said that OSHA should include zoonotic diseases in a new standard, while others suggested that OSHA consider diseases such as shingles, which do not always produce symptoms in infected people.
Worker Infection Control Plan (WICP) and Methods of Compliance
At the July 29 meeting Levinson (OSHA) discussed the Worker Infection Control Plan (WICP) and the methods of compliance element of the potential program standard OSHA is considering. The first element of the WICP would be a written plan similar to other OSHA program standards; OSHA recognizes that employers have already taken steps to ensure worker safety, and stated that employers could integrate their WICPs with existing BBP or other infection control plans used for patient safety. Integrated plans would reduce employer burden while ensuring that workers are protected. The second element of the WICP would include the individuals responsible for WICP oversight, implementation, and daily management. Management occurs on multiple levels, including the facility manager (oversight), the infectious control specialist (implementation), and the front line managers/supervisors (daily management).
Under the potential standard, each WICP would also include standard operating procedures (SOPs) that cover conducting infectious agent hazard analyses, communicating hazard(s), medical surveillance, and exposure incident investigations. The potential standard would also require that SOPs address OSHA's typical hierarchy of controls: engineering, administrative and work practice controls, and personal protection equipment (PPE). The potential standard would also require SOPs to include other elements, depending on the setting. In direct patient care scenarios, SOPs would also include patient scheduling and intake; standard precautions; transmission-based precautions (contact, droplet, airborne); patient placement and transport; and medical surge procedures. In work settings where other covered tasks are performed, SOPs would also include handling and intake of contaminated materials and implementing control measures. In laboratories, SOPs would also include implementing measures to address uncontrolled releases of infectious agents, and addressing standard and special microbiological practices.
Levinson emphasized that under the potential standard, SOPs would not "reinvent the wheel," and the purpose would be to focus on worker protection by incorporating programmatic and administrative elements into the SOPs to apply to specific settings. In developing and updating SOPs, employers would be required to consider current applicable regulations and guidelines of other agencies (such as the CDC) and organizations, and then tailor the relevant elements to their workplace. Employers would be required to make the WICP readily accessible to workers, and to review and update the WICP annually and as necessary. Employers would also be required to solicit workers' input on the WICP, given that workers know what elements are effective for their particular work settings and tasks.
In regard to methods of compliance, employers would be required to implement the elements outlined in their WICPs. Employers would be required to ensure that hazard analyses are conducted, written SOPs are followed, appropriate controls are implemented, appropriate PPE is available and properly used, appropriate worksite cleaning and decontamination procedures are followed, and prompt exposure investigations are conducted. The potential standard would require that hazard analyses be functional and not unnecessarily complicated; employers would be required to implement prompt identification mechanisms, identifying possible exposure to suspected or confirmed infectious diseases at the earliest contact.
In addressing WICPs, stakeholders debated whether OSHA needs to develop a new standard on infectious agents when facilities already have protection plans in place. Stakeholders emphasized the following points in opposition to developing a new standard:
- A new standard on infectious agents would significantly overlap with the existing BBP standard. Hospitals are already in compliance with the BBP standard, with all major hospitals having an infection control plan in place. A new standard would cause duplicative efforts and incur unnecessary costs. A new standard would also cause unnecessary concern among employees and reduce worker flexibility. OSHA should consider incorporating infectious agents into the BBP standard.
- In response to existing guidance (such as CDC guidelines, OSHA respirator use), many facilities already have written plans that address infectious agents (e.g., influenza, TB, unidentified infections). Most places have already implemented engineering controls and have trained and educated staff on practices to prevent the spread of infectious disease.
- OSHA should demonstrate that current hospital practices are insufficient in protecting workers against infectious disease before implementing a new standard that would result in additional costs.
Not all stakeholders were against a potential new standard. Those in favor of it noted that:
- If facilities are already in compliance with other overlapping standards, then additional implementation costs would be minimal. Embedding a WICP into an existing plan (such as an existing infection control plan that already covers 90 percent of the new requirements) would keep costs to a minimum.
- A new standard would give workers an additional incentive to follow CMS standards and CDC guidelines.
- A new standard would help ensure consistency in worker protection.
- Implementing a new standard would ensure results.
- A new standard would refocus the issue on community health and saving lives.
- A new standard would help health and safety officers identify good practices to prevent the spread of infectious diseases.
Stakeholders brought up a number of Implementation issues. They asked OSHA to consider the following points:
- Hierarchy of controls in the healthcare industry: Stakeholders pointed out that the healthcare industry has a different hierarchy of controls compared to other industries. In the healthcare industry, engineering controls are not feasible in situations where infectious agents are not identified. Therefore, administrative controls and work practices typically take precedent over engineering controls. OSHA needs to take this into account if it develops a new standard.
- Airborne transmission: OSHA needs to emphasize the importance of an exposure control plan when dealing with airborne transmissions, stakeholders said. Unlike transmissions that occur through physical contact with an agent, airborne transmissions are not always prevented through the use of technology and physical barriers.
- Risk screening: Stakeholders advised OSHA to consider integrating a risk screening protocol in a new standard.
Medical Screening, Surveillance and Vaccination
Christopher Brown of OSHA discussed the medical screening, surveillance and vaccination elements of the potential program standard OSHA is considering. Under the potential standard, employers would be required to make the following vaccinations available: seasonal influenza and other vaccines and booster doses recommended by the CDC Advisory Committee on Immunization Practices (ACIP). Employers would also be required to provide vaccine-related training (e.g., on the benefits of vaccinations) prior to making vaccinations available to workers. Employers would not be required to make vaccinations available to workers who have already been vaccinated, have documented immunity (e.g., antibody titer), have a medical contraindication, or have chosen to sign a declination form. Employers would be required to perform post-exposure follow-up with workers, to provide information about a worker's exposure to the worker's physician or other licensed healthcare professional (PLCHP), to ensure confidentiality, and to follow PLCHP recommendations for restrictions and modifications to job duties.
Employers would also be required to provide medical removal protection benefits for workers removed from their jobs or medically limited as a result of occupational exposure to an infectious disease. Although OSHA is considering including influenza in a potential standard's vaccination requirements, influenza or the common cold would not be included in the requirements for post-exposure reporting or medical removal protection.
Stakeholders expressed concern over how a new standard would affect employer-mandated vaccinations as a condition of employment. Focusing on how OSHA should not include language that would keep employers from requiring vaccinations as a condition of employment, they discussed the following points:
- In hospitals, public health concerns are the priority. Hospitals do have vaccination requirements as a condition of employment. Employees are also protected by measuring titers that indicate waning immunity. Variations in this requirement are community-specific.
-OSHA should refer to the BBP standard's language on hepatitis B for guidance. Although the BBP standard does not make a hepatitis B vaccination a condition of employment, it includes careful wording about properly informing employees of the benefits of the vaccination and post-exposure evaluation through training.
- OSHA should consider the legal and labor implications of mandatory vaccines. For example, one stakeholder stated that employer may not terminate workers for refusing vaccinations, but may restrict access to certain facility locations and require the worker to change jobs.
Edens clarified that employers may make vaccinations a condition of employment; however, while the potential standard OSHA is considering would require that employers make vaccinations available, that potential standard would not require employees to get them. The potential standard OSHA is considering would require that employers record which employees declined the vaccination, and implement means to train employees on the benefits of vaccinations and the risks associated with declining them.
Regarding declination of vaccinations, stakeholders made the following points:
- A new standard should require an educational program similar to the practices found in the hepatitis B section of the BBP standard. The commenter's BBP practices include an initial information sheet about the vaccination as well as further vaccination education if the worker refuses to get vaccinated. This approach allows the worker to make an informed and positive decision to get vaccinated.
- Most hospitals tend to require mandatory vaccinations. However, some hospitals do not do so. In this latter scenario, a worker who signs a declination form must meet with an epidemiologist to further discuss the implications of refusing the vaccine. This approach has proven to be effective.
- Employees may decline a vaccination if they have been previously vaccinated. OSHA needs to address scenarios where new employees do not have records of past vaccinations.
Stakeholders also expressed thoughts on vaccine-related issues:
- OSHA should not assume that vaccines will be 100 percent effective, and should rigorously pursue other alternative preventive practices. Although vaccination is the preferred method of prevention, OSHA should also consider PPE requirements.
- OSHA should consider vaccine availability issues that occurred during the H1N1 pandemic when supply of the vaccine could not meet the demand. If OSHA develops a new standard, OSHA should address situations where workers are required to be vaccinated but are not on the priority list.
- OSHA should address emerging pathogens in a new standard. Vaccinations will not be possible for all infectious agents.
- OSHA should address the use of investigational vaccines in a new standard. OSHA should consider availability and expense incurred with investigational vaccines.
- OSHA should address the extent of employer responsibility when providing vaccinations. For example, OSHA should consider whether employers are responsible for ensuring that workers receive all subsequent shots in a vaccination series.
Levinson said that OSHA is considering including the CDC's Advisory Committee on Immunization Practices' (AClP) recommendations for healthcare workers and laboratory workers in the potential standard.
There were a number of concerns related to exposure considerations that stakeholders shared:
- OSHA should address how employers determine whether there is occupational exposure to an infectious disease.
- Employers cannot always be aware of exposures. OSHA should emphasize that workers need to be adequately trained and provided with resources and PPE no matter what the exposure scenario.
- Some facilities have an internal risk assessment group that evaluates exposure situations and determines whether a significant exposure has occurred. OSHA should consider this approach if it develops a new standard to prevent unnecessary concern at the workplace.
- OSHA should emphasize the importance of screening, vaccinating and training new workers in a new standard. Employers should be required to immediately screen, vaccinate and train new employees when they first start the job to avoid exposure to infectious agents.
Stakeholders noted that the medical screening, surveillance and vaccination elements of the potential standard OSHA is considering are
already in place in most healthcare facilities.
Communication of Hazards and Recordkeeping
Sharon Carr of OSHA explained that under the potential standard, employers would ensure that appropriate signage and labeling conveys warnings on infectious agent hazards to all on-site and off-site workers (e.g., medical waste handlers) who could be exposed. Examples of signage and labeling that would be required under the potential standard include: signs on patient doors and airborne infection isolation rooms and areas; handwashing signs and posters; and biohazard labels and posters. When training employees, employers would be required to consider all work tasks that involve occupational exposure to infectious agents. Employers would be required to provide training for each covered worker initially (prior to assignment to tasks with occupational exposure), annually thereafter, and on a supplemental basis (e.g., when changes in tasks, procedures, or control measures affect occupational exposure or when the worker's knowledge or actions indicate a need for additional training). Employers would be required to ensure that workers are trained by people knowledgeable about the subject matter, and that the content and vocabulary of the training is appropriate to the worker's language, literacy and education level. During the training, employers would be required to provide workers with an opportunity for interactive questions and answers. Required training would include an explanation of: the signs, symptoms, and modes of transmission, of infectious diseases; vaccination information about infectious diseases; the WICP; all SOPs applicable to the worker's tasks; the use and limitations of control measures and PPE used to prevent or minimize exposure. Employers would also be required to maintain medical records, exposure incident records, and WICP review records. Employers would be required to ensure that medical records are kept confidential. Employers would also be required to make exposure incident records, the WICP, and WICP review records available to workers and their representatives.
Stakeholders emphasized the importance of training and discussed several issues that OSHA should consider:
- Given the number of potential infectious agents, training workers on all potential infectious agents would be impractical. Employers would benefit from conducting risk assessments to identify the infectious agents of concern in their workplace.
- OSHA should provide employers with a default protocol for providing training on novel agents. Employers should follow standard precautions until a diagnosis is determined.
- Workers should be trained on how to report an exposure incident and to whom to report the incident.
- Employers should ensure that a knowledgeable person is available to answer worker questions at the time of training. Given that training can be conducted online (which is frustrating for some workers), this person must be available to workers during training regardless of implementation methods.
- Under the potential standard OSHA is considering, employers would be required to provide training for each worker upon initial start date, annually, and on a supplemental basis. OSHA should also consider requiring training during a pandemic event.
- Employers should consider integrating infectious agent signage and training with other areas of occupational health to streamline and consolidate educational efforts.
Stakeholders said that OSHA should define what constitutes an exposure incident to ensure accuracy and consistency in recordkeeping. They added that OSHA should clarify whether an exposure incident is defined as an initial exposure to an infectious agent or as an outcome-i.e., a diagnosed infection. (For example, CDC defines an incident as one that requires post-exposure care or prophylactics.) OSHA also needs to address exposures and specific reporting requirements in industrial versus research settings.
Underreporting is a significant concern to stakeholders, with some pointing out that healthcare providers often view exposure incidents such as blood splatters as "part of the job." They emphasized that employers should investigate new ways to ensure that employees report exposure incidents. Conversely, some stakeholders were concerned about over-reporting, noting that employees in the lower-paying positions of the healthcare system do not have adequate medical literacy to understand germ theory. They said these employees may have an irrational fear of exposure and may report false symptoms. Training is essential to ensure legitimate reporting. Stakeholders expressed concern over training a multilingual workforce on infectious agents. They said that OSHA should provide guidance on how to address these language differences when providing training. Edens suggested that employers look to current training practices for other aspects of the worker's job on how to address this issue.
Stakeholders Address Key Issues
Stakeholders have submitted hundreds of pages of comments to OSHA that are available through docket number OSHA-2010-0003 at www.regulations.gov. Here's a look at a few select issues:
- The adequacy of existing OSHA requirements to protect workers against occupational exposure. As Paul A. Schulte, PhD, director of the Education and Information Division of the National Institute for Occupational Safety and Health (NIOSH) noted in his submitted comments to OSHA, "It is difficult to assess the adequacy of existing OSHA requirements to protect workers against occupational exposure to infectious agents because of the lack of routine surveillance of occupationally transmitted infections. Enhanced surveillance systems would help answer this question."
- Whether OSHA's deliberations on occupational exposure to infectious diseases should focus on only droplet and airborne transmission or if contact transmissible diseases should also be included. Schulte notes in his submitted comments to OSHA, "Contact transmission is important in the healthcare setting. Contact, droplet and airborne transmission may all play a role in the spread of some infectious agents, such as influenza virus, and any effort to reduce transmission should address all routes of exposure."
- How to determine which employees are potentially exposed to contact, droplet and airborne transmissible diseases in workplace. In its comments to OSHA, APIC pointed out several key principles in determining who is at risk:
1. Hospitals are concerned about the health and safety of all occupants, whether patients, healthcare workers or visitors. Therefore elements of the IPC program must include airborne, droplet and contact assessments, as well as attention to environmental/engineering controls for the environment affecting all occupants.
2. A risk assessment is developed for the specific population served and for the types of communicable diseases likely to be seen in the specific facility. For this purpose, the facilities utilize reportable communicable disease entries published weekly from local and state agencies as well as the CDCs weekly Morbidity and Mortality Weekly Report (MMWR). Therefore, specific issues may vary by locale. The best example is M. tuberculosis, (TB) for which CDC guidelines indicate that some areas may have minimal risk and need not carry out TB testing nor develop respiratory protection programs.
3. General risks for healthcare workers (HCWs). All hospital personnel, whether they perform direct care or support services, are considered at some level of risk. Because HCWs may come into contact with patients, and all patients are considered potentially infectious, Standard Precautions apply to all and all HCWs receive basic education and training in how to prevent risk of infection to themselves and patients.
4. Specific risks. The disease exposure risk is similar for HCWs with direct contact with patients in adult populations and pediatric and neonatal populations. The risk assessment considers for example: whether a patient is suspected or known to have a communicable disease; the type and typical mode(s) of transmission, frequency and length/intensity of procedures, and the degree of contact. For example, risks are higher for HCWs working the emergency room evaluating patients with potential communicable disease (e.g., MTB) and could involve staff carrying out pulmonary procedures such as bronchoscopy. Additionally, some facilities may consider employees colonized with a multi-drug resistant organism (MDRO) such as MRSA to be the result of a prior occupational exposure, but it is very difficult to determine whether the colonization or infection was acquired on the job or from the community, since MRSA is widespread in the community. IPC programs place major emphasis on prevention and routine use of Standard Precautions. The IPC programs address potential risks by department/procedures and indicate if specific additional personal protective equipment should be used in addition to Standard Precautions. Members are encouraged to share samples of the exposure assessments or exposure control plans they use when assessing newly hired staff and needs for specific job training.
- Problems/obstacles that an institution encountered with implementing specific control measures, and control measures that have been ineffective or unnecessary. Paul Schulte of NIOSH pointed to the common barriers to a compliant respiratory protection program, including not wearing masks/respirators because they are uncomfortable, do not fit properly, interfere with communication and performance, and are not easily accessible when needed. He also pointed out that in order for healthcare workers to behave safely, three conditions must be met: the worker must have the necessary, knowledge, skills and ability; the worker must be properly motivated; and the worker must receive the necessary environmental and organizational support. Further, the employer must be committed to a culture of safety and ensure that its occupational safety and health program is closely tied to it.
- How workplaces determine PPE usage, particularly masks and respirators. Schulte emphasized the importance of matching PPE recommendations (such as those contained in the document "The Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel" from the CDC). A stratified respiratory protection approach may be justified for response to the risks of exposure to airborne transmissible infectious diseases.
- Whether there is a need for a more rigorous certification/approval process for face masks and additional independent verification of the protective properties of these devices. Schulte shared that NIOSH is sponsoring a study by the Institute of Medicine Committee on the Certification of Personal Protective Technologies to investigate the current status of certification programs for various types of PPE. The IOM committee is gathering information on the different procedures and criteria used to evaluate currently certified PPE and any additional certification activities that may be advisable.
The overriding issue for a number of healthcare professionals is the direction OSHA is pursuing, as well as potential ramifications on the infection prevention and healthcare epidemiology communities. In a letter to David Michaels in late 2010, Richard Whitley, MD, past-president of the Infectious Disease Society of America (IDSA), explained that the society had concerns about the potential scope and breadth of this potential undertaking because The advantages of establishing a new standard for healthcare workers can be easily outweighed by the unforeseen consequences caused by such a standard, particularly if the standard is not supported by scientific evidence. Whitley asked OSHA to directly involve expert stakeholder groups, such as IDSA, while investigating the need to create such a standard.
Whitley writes, With this RFI, OSHA appears to be moving in a direction similar to its bloodborne pathogen standard in terms of focusing on regulating exposure to infectious agents, rather than the prevention of the infections themselves. OSHAs bloodborne pathogen standard was valuable, in that it encouraged facilities to be proactive in the preparation for and the prevention of exposures to blood and body fluids. Taking a parallel approach for other occupational exposures may prove problematic. For example, a facility cannot prevent exposures to methicillin-resistant Staphylococcus aureus (MRSA) without universal screening for MRSA colonization or infection. A facility also cannot regulate a healthcare workers exposure to a patient with a respiratory infection without first instituting Centers for Disease Control and Prevention (CDC) guidelines. Of importance, compliance with existing CDC guidelines already is monitored by the Joint Commission, the Centers for Medicare and Medicaid Services, and at the local level by state health departments (with some having stricter standards than those at the federal level).
Whitleys letter continues, From a patient and healthcare worker safety perspective, IDSA strongly believes that setting a standard to regulate exposure, without addressing infection prevention and control, may create a host of unintended consequences. IDSA sees a need for greater infection prevention and control practices in hospitals as well as in non-traditional healthcare settings, such as in-home healthcare or same day surgery centers. Infection prevention and control through standard precautions and vaccination is evidence-based, whereas a standard focused solely on exposure, is not. Exposures occur in a variety of settings, and it is often difficult to determine where the exposure first occurred. Data presented by the CDC has shown that in the case of H1N1, many healthcare workers were exposed to the virus at home or in the community. As such, a standard focused on limiting exposures in healthcare and healthcare-related settings would have had less impact than a standard supporting mandatory vaccination of HCWs against H1N1 or seasonal influenza.
A final point made by Whitley is that a potential rule that covers all infectious diseases has the potential to be extremely impactful on facilities and facility resources, without necessarily achieving greater patient or healthcare worker protections. Whitley continues, A regulatory standard focused on exposures places an inherent burden on facilities to track and document the large number of potential exposuresthe vast majority of which are trivial in natureand are unlikely to lead to transmission (an example being a patient with a cold). The burden on smaller healthcare facilities could be enormous. Considering most U.S. hospitals have fewer than 100 beds, the burden on the facility to provide this level of documentation would be grave, not only impacting facility resources, but human resources as well. IDSA recommends OSHA take a measured approach by first evaluating the data on healthcare worker exposure to determine where deficiencies exist, rather than applying a regulatory standard to any and all modes of exposure in any and all potential healthcare or healthcare-related settings. Research funding to measure the best approaches is greatly needed. We caution OSHA to first focus on basic personnel and infection prevention and control policies before attempting to regulate infectious diseases exposure in the universe of healthcare settings. Finally, it is imperative that OSHA directly reach out to professional societies and other stakeholders during each step of this potential rulemaking, as it has the potential to radically impact healthcare in the United States. Such inclusion and a fully transparent process will help to ensure there are as few unintended consequences as possible, not only ones borne by facilities, but by patients and HCWs as well. IDSA stands ready to help.
At the July 29 stakeholder meetings, Levinson said that next steps include discussions with David Michaels and other relevant federal agencies (such as the U.S. Department of Health and Human Services) to present them with the feedback obtained from these meetings. Levinson emphasized that OSHA is an evidence-based agency and will use solid evidence in moving forward in this process. He also emphasized that the development of a program standard is only one action that OSHA is considering to control worker exposure to infectious agents. OSHA will inform stakeholders of Michaels' decision on how OSHA will proceed with respect to occupational exposure to infectious diseases.
Occupational Safety and Health Administration (OSHA) Summary Report of Stakeholder Meetings on Occupational Exposure to Infectious Diseases. Washington, D.C. July 29, 2011.