OSHA is interested in feedback from SERs on whether employees with occupational exposure at diagnostic laboratory facilities, like employees at research and production facilities, should be offered targeted vaccinations only, or whether they, like other employees that would be covered under a rule as outlined in the regulatory framework, should be offered the minimum set of vaccinations listed above.  OSHA believes that at least some employees in diagnostic laboratory facilities work with samples containing unidentified potentially infectious agents and, therefore, should be offered the minimum set (unlike workers in research and production laboratory settings, where the infectious agents to which workers have occupational exposure are known).
OSHA's aim in the regulatory framework is to promote and encourage worker cooperation in the vaccination program by ensuring that the employer offers appropriate vaccinations at no cost to employees and provides appropriate educational material on the benefits and risks of such vaccinations (the latter aim is described under Section 6, Training).   Per the regulatory framework, OSHA would permit workers to decline required vaccinations, but, in such cases, the employer would be required to obtain and retain a signed declination statement and to make the vaccination available to any worker who decides to accept the vaccination after initially declining it.  These provisions would encourage greater participation in the vaccination program by reiterating that a worker declining vaccination remains at a greater risk of acquiring infectious diseases than vaccinated workers, would benefit the employer by making it easier to determine vaccination status during the investigation of an exposure incident (e.g., because of the provision that would require signed declinations), and would allow resources to be directed toward improving the acceptance rate of the vaccination program.
Per the regulatory framework, OSHA would cover medical removal protection (MRP).  The employer would be required to follow a PLHCP's recommendations concerning modifications or restrictions to a worker's job duties, or precautionary removal of a worker from the workplace (e.g., to protect patients or coworkers).  When a worker has been removed from the job or is otherwise medically limited as a result of an exposure incident, the employer would be required to pay, to the worker, the worker's total normal earnings and to maintain the worker's seniority and all other worker rights and benefits, including the worker's job status.  A rule that would require employers to provide MRP benefits would encourage employee participation in (and therefore increase the effectiveness of) the medical surveillance program that would be required by such a rule by ensuring that reporting symptoms or health conditions to the PLHCP would not result in loss of job or pay.
Per the regulatory framework, OSHA would permit several limitations on MRP benefits.  Per the regulatory framework, OSHA would not require MRP benefits for those workers removed from their jobs or otherwise medically limited as a result of occupational exposure to the common cold or influenza, with one exception.  In research and production laboratory facilities, if a worker is removed from the job or otherwise medically limited as a result of an exposure incident to any infectious agent with which the employee is working (including the common cold or influenza viruses), OSHA would require the employer to provide MRP benefits to the worker.  Per the regulatory framework, OSHA would require the employer to provide medical removal benefits only until the worker is determined to be noninfectious or is otherwise able to return to normal duties, and, in any case, OSHA would limit the required provision of benefits to a period not exceeding 18 months.  Any potential obligation to provide MRP benefits to a removed or restricted worker would also be reduced to the extent that the worker receives compensation for earnings lost during the period of removal either from a publicly or employer-funded compensation program, or from employment with another employer made possible by virtue of the worker's removal.  Finally, even if MRP benefits are not required in a particular case, under the regulatory framework, the employer would not be precluded from offering administrative or sick leave for medical removal of a worker.
Based on the regulatory framework, the employer would be required to ensure that employees' medical records are kept confidential and not disclosed or reported, without the employee's written consent, to any person within or outside the workplace, except as would be required by OSHA or as may be required by law. Regarding privacy issues under HIPAA regulations, OSHA's assessment is that as long as the information disclosed to employers by PLHCPs is limited to findings concerning a work-related illness or injury or workplace-related medical surveillance, and that the employee is given notice of such disclosure, that the regulatory framework's requirements for employers to receive, maintain, and possibly disclose employee health information are not in conflict with HIPAA.
Training
Section 6 of the regulatory framework covers worker training.  Worker training is critical to the success of any infection control program.  Unless workers have sufficient knowledge and understanding of the program, including how to recognize hazards and protect themselves, the intent and effectiveness of the program will be undermined.  Per the regulatory framework, OSHA would require the employer to provide training as follows: initially, prior to the time of assignment to tasks where occupational exposure may take place; annually thereafter, not to exceed 12 months from the previous training; and supplemental training to address specific deficiencies.  Both initial and periodic worker training are recognized as important components of an effective infection control program.  Initial training provides information that workers need to protect themselves against occupational exposures to hazards, while periodic training refreshes worker knowledge, reinforces the importance of the infection control program, and provides a means of introducing new information and procedures (which is especially important in the infectious disease realm, given the likelihood of changes in technology, the possibility for the appearance of new or emerging infectious agents, and other changes that occur markedly over time).
To ensure that the employer's training program is adequate and meaningful, OSHA would require that the program: be overseen or conducted by a person knowledgeable in the program's subject matter as it relates to the workers' workplace; consist of material appropriate in content and vocabulary to the educational level, literacy, and language of workers; and provide an opportunity for interactive questions and answers with a person knowledgeable in the program's subject matter as it relates to the workplace.
The provisions for worker training in the regulatory framework are performance-oriented, listing categories of information that would be provided to workers, including, among other elements:  a general explanation of the epidemiology and symptoms of common infectious diseases, including the signs and symptoms of infectious diseases that require further medical evaluation; an explanation of the modes of transmission of infectious agents and applicable infection control practices (e.g., standard and transmission-based precautions) so that the worker can recognize tasks and other activities that may involve occupational exposure and take precautionary measures; information on vaccines that will be made available to the worker, including their efficacy, contraindications, likelihood and severity of possible adverse health effects, method of administration, the benefits of being vaccinated, and that the vaccines and vaccinations will be offered at reasonable times and places at no cost to the worker; an explanation of the employer's WICP and the means by which the worker can obtain a copy of the plan; training on all of the SOPs developed as part of the WICP that are applicable to the worker's duties; an explanation of the use and limitations of engineering, work practice, and administrative controls; and information on the types, proper use, limitations, location, handling, decontamination, removal, and disposal of PPE.
OSHA believes that the approach taken in the regulatory framework would ensure that important information is communicated to workers that will enable workers to understand the hazards associated with infectious agents, while, at the same time, allowing employers the most flexible approach to providing training.
Recordkeeping
Like OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030), per the regulatory framework, OSHA would require a recordkeeping element in an infectious diseases rule.  Per Section 7 of the regulatory framework, OSHA would require the employer to maintain medical records and exposure incident records for at least the duration of employment, plus 30 years.  Maintenance of records for 30 years is currently a provision in the BBP standard.  Like some of the diseases covered by the BBP standard (i.e., HIV and Hepatitis B), infectious diseases that would be covered under the ID rule may also have chronic, long-term effects such as cancer, negative reproductive consequences, and organ damage (e.g., lung damage from TB).
In addition, the employer would be required to retain records of WICP reviews for three years.  The maintenance of WICP review records is important for employers to assure that they have addressed prior concerns as part of the continuous improvement process. The maintenance of exposure incident records would allow the employer to document elements such as the work setting and work task(s) being performed when the exposure incident(s) occurred, which would, in turn, allow the employer to focus efforts on decreasing or eliminating specific circumstances or routes of occupational exposures.  The maintenance of medical records is essential to permit proper evaluation of the worker's immune status and proper healthcare management following an exposure incident.  And the maintenance of all three types of records is important to allow compliance with the potential obligation in the regulatory framework to make such records available to workers and OSHA upon request.
Cost and Availability
Per the regulatory framework, OSHA would require that the implementation of all requirements be at no cost to the worker, that all time required by a worker to comply, including time for training, medical evaluations/procedures, and reasonable travel time (as appropriate), be considered compensable time, and that any required medical evaluations and procedures (including vaccinations and post-exposure evaluation and follow-up) and training be made available to the worker at reasonable times and places.  OSHA believes that requiring employers to pay workers for the time associated with compliance with a rule as outlined in the regulatory framework, and giving workers reasonable opportunities to participate in medical evaluations and procedures and training, will help encourage worker participation in (and therefore increase the effectiveness of) a rule as outlined in the regulatory framework, and would help OSHA to ensure that employers are making good faith efforts to comply.

Section V.  Description of the Entities, Establishments, and Employees Likely to be Affected by a Rule as Outlined in the Regulatory framework
Introduction
In this section of the SER Background Document, OSHA provides preliminary estimates of the number of affected entities, establishments, and employees for the industries that have settings that would be affected by a rule as outlined in the regulatory framework.  The term "entity" describes a legal for-profit business, a non-profit organization, or a local governmental unit, whereas the term "establishment" describes a particular site of economic activity.  Some entities own and operate more than one establishment.
As discussed in Section IV of this SER Background Document, OSHA would cover settings where direct patient care is provided and settings where other covered tasks are performed.  The Agency has translated the settings where these tasks will be performed into the following four categories:  (1) settings where direct patient care is provided; (2) settings where there are contaminated materials originating from settings where direct patient care is provided; (3) settings where there is exposure to human remains; and (4) diagnostic, research, and production laboratory facilities, where there is exposure to contaminated materials.
This analysis focused on worker tasks and the industries where those tasks that would expose workers to infectious agents would be performed.  This method accounts for the fact that an establishment may employ both workers who perform direct patient care and workers who perform other covered tasks (as those terms are used in the regulatory framework).  For example, in hospital settings, doctors and nurses provide direct patient care, while custodial workers perform other covered tasks.
Finally, this analysis accounts only for entities that have employees.  Entities that do not have employees (e.g., self-employed individuals) are not covered by OSHA.
OSHA requests comments on the preliminary estimates in this section with respect to two issues.  First, has OSHA stated clearly in the regulatory framework who would be covered by a rule as outlined in the regulatory framework, or would additional clarification of scope terms such as, "direct patient care", "other covered tasks", and "occupational exposure", be needed?  Second, is the scope of worker tasks that would be covered appropriate?  Should OSHA cover more types of worker tasks than are envisioned in the regulatory framework?  Alternatively, should OSHA cover fewer worker tasks?
Criteria for Determining Whether For-Profit Businesses, Non-Profit Organizations, and Governmental Units are Small Entities
There are three types of small entities under the RFA: (1) small businesses; (2) small non-profit organizations; and (3) small governmental jurisdictions.  The Small Business Administration (SBA) uses the North American Industry Classification System (NAICS) as a basis for determining whether businesses are small for given industries.  SBA size criteria vary by industry, but are usually based on either number of employees or revenue.  A small non-profit organization is any not-for-profit enterprise that is independently owned and operated and not dominant in its field.  Finally, a small governmental jurisdiction is a government of a city, county, town, township, village, school district, or special district with a population of less than 50,000.
Table V-1 displays size criteria, derived from SBA definitions, for for-profit entities that OSHA believes would be affected by a rule as outlined in the regulatory framework.
For the purposes of the analysis in Table V-1, OSHA grouped entities into aggregate categories made up of entities that are performing similar types of healthcare services or other covered tasks.  These aggregated settings include entities from various NAICS industries.  Since each six-digit NAICS industry has its own threshold for being considered a small entity by SBA, the SBA size criteria often appear as ranges in Table V-1.  The SBA criteria and corresponding OSHA-estimated employee size thresholds by six-digit NAICS industry are presented in Appendix A at the end of this document. (OSHA converted the SBA revenue criteria for for-profit entities to an equivalent employee size threshold, as shown in Table V-1.)
The SBA criteria and corresponding OSHA-derived employee size thresholds are more fully documented in Appendix A at the end of this document.

Affected Entities and Establishments
Table V-2 presents OSHA's preliminary estimate of the number of affected entities, establishments, small entities, and very small entities (i.e., entities with fewer than 20 employees) for each type of setting presented above.  This preliminary estimate shows that, out of an estimated 637,000 entities that would be affected by a rule as outlined in the regulatory framework, approximately 625,000 are SBA-defined small entities and approximately 555,000 are very small entities.  Moreover, approximately 217,000 of the affected SBA-defined small entities are non-profit.

Affected Employees
Tables V-3a, V-3b, and V-3c present, by size and setting, OSHA's preliminary estimates of the number of employees that would be affected by a rule as outlined in the regulatory framework, including employees that provide direct patient care and employees that perform other covered tasks, and the total number of employees in both groups (i.e., the total number of employees that would be affected by a rule as outlined in the regulatory framework).  As shown in Table V-3c, OSHA preliminarily estimates that approximately 9 million employees would be affected by a rule as outlined in the regulatory framework, and that of these, about 5.8 million are employed by SBA-defined small entities.  These preliminary estimates show that approximately 2.2 million workers in SBA-defined for-profit small entities and small government entities provide direct patient care, while an additional 203,000 workers in those entities are engaged in other covered tasks (as those terms are used in the regulatory framework).  The Agency preliminarily estimates that approximately 3 million workers provide direct patient care, and 300,000 workers perform other covered tasks, at SBA-defined small, non-profit entities. OSHA preliminarily estimates that 1.5 million workers are employed by entities with fewer than 20 employees, where approximately 1.3 million workers provide direct patient care, while about 140,000 perform other covered tasks.

Section VI.  Description of Potential Impacts of a Rule as Outlined in the Regulatory framework

A.	Introduction
In this section, OSHA presents preliminary estimates of potential impacts on employers who would be required to come into compliance with the provisions of a rule as outlined in the regulatory framework.  Here and throughout this SBAR Panel process, the Agency will not be presenting aggregate costs but, instead, will be focusing on potential impacts presented in their simplest and most natural units of measure -- sometimes as dollars and sometimes as time requirements.  The potential impacts of concern here are those of a single item or action, such as a worker receiving a vaccination.  In this example, there would be two relevant impacts: (1) the cost of a single dose of the vaccine, reported in dollars; and (2) the time necessary for a nurse to provide, and the worker to receive, the vaccine, reported in minutes or hours.  Such impacts help generalize the discussion because many unit costs do not vary by setting or establishment size.
While the unit costs may be the same for various types and sizes of settings, the total costs will be highly dependent on the type of facility and on the number and types of infectious agents a given facility would typically encounter.  Some of the costs would be incurred one time, up front for all facilities (e.g., developing a WICP or written respiratory protection program if the facility currently does not have one), but many of the costs (e.g., hand hygiene or PPE use) are based on the number of interactions workers have with infectious patients or materials.  In addition, the flexibility inherent in a program standard allows employers whose facilities generally do not treat infectious patients to take simple steps to deal with such patients.  For example, a small podiatrist's or dentist's office could simply require patients presenting with flu-like symptoms or symptoms of a respiratory illness to reschedule their appointments, rather than implement full droplet and/or airborne precautions for their workers.  (The offices would, however, still be required to institute Standard Precautions for their workers).  Some of these various compliance methods were addressed in Section IV of this document, and, throughout this section, OSHA will discuss how the total costs of a provision might vary based on the type or size of a facility.
For the purposes of the SBREFA process and panel, OSHA developed preliminary estimates of unit costs for almost all items in the regulatory framework that would result in costs to employers if those items were included in a rule.  As mentioned above, these unit costs account for the cost or time for a single item to be purchased or for a single action to be taken.  In developing these estimates, OSHA based unit costs on those actions and costs the Agency preliminarily determined an employer would need to undertake or bear to comply with the regulatory framework.  OSHA assigned costs in either dollars, for items that would need to be purchased, or in time, where an action would need to be taken.  OSHA preliminarily concludes that some provisions of the regulatory framework would not have associated costs because, for example, the Agency believes that a provision is already standard practice or that complying with a provision would require only a modification of current practices without requiring additional time or resources.   OSHA presents a summary table, Table VI-9, that shows all estimated unit costs at the end of this section.
In addition to preliminary estimates of unit costs, OSHA developed preliminary estimates of levels of current compliance with many of the provisions of a rule as outlined in the regulatory framework.  These estimates are discussed in more detail throughout this section of the SER Background Document.
      1.	Preliminary Estimates of Unit Costs
An employer's total costs will depend on:  the number of employees the employer has that would be affected under the scope of a rule as outlined in the regulatory framework; the number of times certain procedures would need to be completed or the number of nondurable items (such as gloves, soap, or vaccines) employees would need to use to comply with a rule as outlined in the regulatory framework; the hours that would be needed to ensure that contractors, vendors, and licensed independent practitioners with privileges, at a minimum, adhere to infection control practices consistent with the employer's WICP (assuming the employer is a host employer); and the extent to which the employer is already in compliance with provisions in the regulatory framework.  OSHA is still in the process of developing estimates for these elements.  Most importantly, the Agency has not yet made a preliminary determination as to the number of workers who would be subject to the requirements of any given potential provisions (i.e. how many workers will need to be vaccinated or how many workers will receive respirator fit-testing).  Because the work to develop key estimates is still in progress, OSHA will not be presenting total costs as a part of this SER Background Document.
      2.	Preliminary Estimates of Current Compliance
The preliminary analysis in this section of the SER Background Document summarizes preliminary evidence of current baseline compliance in settings that would be subject to a rule as outlined in the regulatory framework.  The source of this data is a Draft Report on the Expert Elicitation on Infectious Disease Control in Healthcare and Other Settings (hereafter "Draft Report on Current Compliance" or "Draft Report"), conducted by OSHA's contractor, Eastern Research Group, Inc. ("ERG"), in 2013.  As with other non-copyrighted references in this SER Background Document, the Draft Report is available online under docket number OSHA-2010-0003.
ERG prepared the Draft Report by eliciting opinions from a panel of experts on infection control about the levels of current compliance with many of the provisions outlined in the regulatory framework.  While the Draft Report has assisted OSHA in establishing preliminary estimates of current compliance, the Agency is still reviewing these estimates and is interested in any feedback the SERs may have on the levels of current compliance presented throughout this section of the SER Background Document.  If OSHA engages in rulemaking, it will take any such feedback into consideration in preparing a preliminary estimate of baseline compliance and total costs to industry.
OSHA's preliminary estimates of current levels of compliance, presented in this section of the SER Background Document, are the average of the experts' responses, which were weighted based on the experts' self-reported confidence levels.  The experts were asked to judge their levels of confidence in their answers to both the overall questions and the occupational settings at issue in the questions, and those levels of confidence were used to give proportionally more weight to answers given by more confident respondents (see Section 2.2.6 of the Draft Report).  While the range of answers varied widely on many questions and for many settings (see Appendix A to the Draft Report), the weighted average and the median were relatively close.  As stated above, OSHA has made no final determination on current levels of compliance and seeks additional feedback from the SERs on the preliminary estimates of levels of compliance presented in this section of the SER Background Document.
OSHA discusses specific estimates of baseline compliance in relevant parts of this section of the SER Background Document.  See Table VI-10, at the end of this section of the SER Background Document, for more details regarding OSHA's preliminary estimates of compliance.  And as stated earlier, ERG's full Draft Report is available in the docket.
      3.	Request for Feedback
OSHA encourages the SERs to comment on all elements of this preliminary cost analysis, including the preliminary estimates presented here and any estimates not presented because the Agency is still in the process of developing them.  OSHA solicits comments about the following issues:
   * Are the unit costs that are presented in this section of the SER Background Document reasonable?

   * Are there types of costs, actions, or items that the Agency is either over- or under-estimating, or that the Agency has failed to consider at all?

   * Are the Agency's preliminary estimates of the actions that an employer would be required to undertake to comply with individual provisions in the regulatory framework consistent with the understanding of the SERs?

   * Are the Agency's preliminary estimates of current compliance consistent with what the SER's have observed in their own industries?

   * Are the Agency's preliminary determinations with respect to the provisions of the regulatory framework for which most employers would not incur additional costs, over and above current practice, consistent with the understanding of the SERs?  If not, what additional costs, over and above current practice, would employers need to bear to comply with the relevant provisions of a rule as outlined in the regulatory framework?

   * Are there any potential provisions for which OSHA has presented cost estimates that the SERs believe would not require employers to undertake additional actions or incur additional costs, over and above current practice?
OSHA will solicit further comment on specific cost issues throughout this section of the SER Background Document, but also welcomes comments on issues not specifically addressed.  OSHA considers the feedback and information provided by the SERs to be a very important part of the development of the preliminary economic analysis and the initial regulatory flexibility analysis and welcomes all comments.
B.	Potential Impacts of Provisions in the Regulatory framework
   1.          Worker Infection Control Plan (WICP)
Per the regulatory framework, OSHA would require employers to develop written WICPs designed to prevent or minimize the transmission of infectious agents to each worker.  The WICP could be part of a larger plan, such as one addressing patient safety or bloodborne pathogens, but, in such cases, the WICP would need to be a cohesive document, in and of itself, or there would need to be a guiding document that identifies the elements of the larger plan that comprise the WICP.
OSHA would require that the WICP include a write-up of the following elements:
   * The name and title of, and contact information for, the plan administrator responsible for  WICP implementation and oversight;
   * The name of the person(s) responsible for the daily management of the WICP;
   * An exposure determination; and
   * The SOPs for the employer's work setting(s).

OSHA would require employers to review and update the WICP at least annually, and to share the WICP with contractors, vendors, licensed, independent practitioners with privileges, and the employer's workers.
As shown in Table VI-1, below, OSHA preliminarily estimates that the time required initially to complete a written WICP ranges from 20 hours for lower risk work settings to 40 hours for higher risk work settings.  Lower risk work settings are work settings, such as embedded clinics in schools and industry and medical equipment handling and reprocessing facilities, that have fewer types of healthcare workers and where workers either have fewer encounters with potentially infectious patients or are potentially exposed to fewer types of infectious agents.  Higher risk work settings are work settings, such as hospitals and other patient care settings, that have the most types of healthcare workers and where workers have more encounters with potentially infectious patients and are potentially exposed to the widest range of possible infectious agents.
The estimates presented here and below in Table VI-1 with respect to initial development of the WICP are based on the median estimates of the time necessary to prepare a WICP, as estimated by the expert panel on current compliance.  These time estimates assume that employers would be formulating a WICP from start to finish and do not take into account the fact that some employers currently have WICPs that would be either partially or fully in compliance with a rule as outlined in the regulatory framework.  One participant in the panel initially suggested that it would take a hospital 2,880 hours to develop a WICP, but reduced this response to 480 hours in a second round of questioning (see Section 4.1 of the Draft Report).  The remaining experts reported that facilities could augment or tweak available templates to fit their particular settings (Id.).  Given the availability of infection control plans for purchase, OSHA believes the preliminary estimates in Table VI-1 are reasonable, but the Agency is still developing the estimates and would be interested in feedback from the SERs on the issue.
As shown in Table VI-1, OSHA preliminarily estimates that the time necessary to review and update a WICP annually, and to share the WICP with all affected parties, would range from four hours for lower risk work settings to sixteen hours for the highest risk industry -- hospitals.  As with the preliminary estimates of WICP development time, these estimates are based on the responses of the expert panel.

Costs related to developing and updating a WICP would be incurred by all facilities not currently in compliance with this potential provision.  As shown in Table VI-1, different types of settings would have different costs, a variability that is based on the number of patients, the volume of infectious materials handled, and the number of types of infectious diseases that might be encountered, in different types of settings.  Some facilities may have even lower costs to develop their plans than the costs shown in Table VI-1 if their workers do not have reasonably anticipated exposure to certain types of infectious diseases.  For example, an employer would only incur costs to develop a plan related to contact-transmissible diseases if the employer reasonably anticipates that workers would be exposed to contact-transmissible diseases.

Based on the estimates of the experts questioned by OSHA's contractor, the Agency preliminarily estimates that about 94 percent of hospitals, 90 percent of long term care facilities and nursing homes, and 90 percent of laboratories have a written WICP (see Table VI-10 and Draft Report).  On the other hand, just 39 percent of establishments in "other occupational settings," which includes morgues and mortuaries, waste collection and handling services, and laundry services, are preliminarily estimated to have a written WICP (Id.).  Finally, between about 40 and 60 percent of establishments in the other settings examined are preliminarily estimated to have a written WICP (Id.).
Also, based on the estimates of the experts questioned by OSHA's contractor, the Agency preliminarily estimates that most hospitals (77 percent) and laboratories (70 percent), as well as a majority of nursing home and long-term care facilities (63 percent), review their WICPs on an annual basis (Id.).  A smaller percentage of physicians' offices (16 percent), dentists' offices (18 percent), and "other occupational settings" (12 percent) are preliminarily estimated to review their WICPs annually.  OSHA welcomes feedback from the SERs on these preliminary estimates of current levels of compliance (Id.).
   2.          Implementation of Standard Operating Procedures ("SOPs")

OSHA is presenting the potential impacts for implementation of the elements of the SOPs laid out in the regulatory framework.  Under a rule as outlined in the regulatory framework, individual employers would not incur costs associated with all of these elements since the SOPs each employer develops would be dependent on the types of risk seen in that employer's work setting(s).  For example, a dentist's office would not incur costs to maintain an airborne infection isolation room (AIIR) since this type of establishment would not have one.  Where OSHA has estimated that only certain settings are affected by a given provision in the regulatory framework, the unit costs are presented for those settings only.  In addition, OSHA has preliminarily found that the implementation of some of these procedures will involve changes in work practices without additional time or equipment costs, other than those costs associated with incorporating these new work practices into a WICP, which is addressed above, and training on these new work practices, which is addressed below.
         a. SOPs For All Affected Work Settings
Per the regulatory framework, all employers would be required to develop and implement certain SOPs, including SOPs on:
Infectious Agent Hazard Evaluations and Communication of Hazard Evaluation Results
Per the regulatory framework, OSHA would require employers to implement SOPs for the conduct of infectious agent hazard evaluations to identify suspected or confirmed sources of infectious agents.  Based on OSHA's current thinking, the hazard evaluation would not need to be a written document and could be incorporated into routine activities, such as triage and patient scheduling.  OSHA would require the employer to communicate the results of the hazard evaluation and the status of any suspected or confirmed sources of infectious agents to the person(s) responsible for implementing appropriate worker protection precautions.
OSHA preliminarily concludes that performing an infectious agent hazard evaluation, and communicating the results of that evaluation, as those potential provisions are laid out in the regulatory framework, would not take additional time over existing practice, and could be accomplished by modifying current job duties.  Additional training (discussed later in this section of the SER Background Document) would provide workers with the background knowledge and procedures necessary to perform evaluations and communicate results in the course of their normal job duties.
Moreover, per the Draft Report of Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that 81 percent of hospitals, and 79 percent of long-term care facilities and nursing homes, already conduct infectious agent hazard evaluations.  OSHA also preliminarily estimates that only 20 percent of establishments in "other occupational settings," which includes morgues and mortuaries and waste handling and laundry services, only 28 percent of dentists' offices and between about 40 and 60 percent of establishments in the remaining settings already conduct these activities.  As mentioned previously, OSHA considers these estimates to be preliminary and is interested in incorporating feedback from the SERs on current levels of compliance in preparing final estimates for the preliminary economic analysis.
OSHA is interested in any information the SERs have on this issue.  OSHA also asks the following:
   * How are hazard evaluations currently performed and how are those results communicated to the relevant parties?
   * Would conducting a hazard evaluation, as described both above and in Section IV of this document, require additional time above that preliminarily estimated by OSHA?
   * To what extent are facilities currently complying with this potential requirement?
Hand Hygiene
Per the regulatory framework, OSHA would require employers to have SOPs to ensure that handwashing facilities are available and accessible, and that recognized and generally accepted good infection control practices for hand hygiene are followed.  CDC recommendations on hand hygiene vary depending on the specific circumstances.  In general, CDC recommends handwashing with soap and water, or if handwashing facilities are not available, using alcohol-based hand sanitizers containing at least 60 percent alcohol (CDC, 2013c).  In situations where healthcare workers (HCWs) are routinely providing care to numerous patients, CDC recommends, in the absence of visible soiling of hands, using approved alcohol-based hand sanitizers rather than soap and water (CDC, 2002a).  Using such hand sanitizers improves hand hygiene compliance due to their convenience and lower levels of associated dermatitis.  In laboratories, however, CDC/NIH recommends handwashing with soap and water (CDC/NIH, 2009).
OSHA preliminarily estimates, based on WHO recommendations (WHO 2011a, WHO 2011b), that proper hand hygiene using soap and water washing takes 50 seconds of a worker's time, and that hand hygiene using an alcohol-based hand sanitizer in an effective manner takes 25 seconds of a worker's time.  These times are estimated to be consistent across all settings within the scope of the regulatory framework.
While the time necessary to perform hand hygiene is consistent across facilities, the total costs of implementing SOPs for hand hygiene would vary based on the number of employees, the number of patients with which those employees interact on a daily basis (or, for workers handling infectious materials, the number of times gloves are removed during a work shift), and the type of hand hygiene (soap and water or alcohol-based) employed.  Hand hygiene should be performed at a minimum before and after each patient encounter and, under some circumstances, at additional times during a patient encounter (for example, after contact with blood, body fluids, or contaminated surfaces (even if gloves are worn) or before invasive procedures) or, for workers who are handling hazardous or potentially hazardous materials like medical waste or linens, hand hygiene should be performed at a minimum after gloves are removed and anytime ungloved hands come into contact with known or suspected contaminated materials.  Second, since alcohol-based hand rubs take less time for employees to use and the dispensers can be easily mounted in most settings, employers may, in certain situations, be able to achieve compliance with this potential provision in a less costly manner.
In small facilities that have only a few employees who interact directly with patients, the number of times hand hygiene is performed, and therefore the cost of implementing SOPs for hand hygiene, would be considerably lower than the corresponding numbers for large providers with many employees and patients.  Likewise, in settings where other covered tasks are performed, like laundry facilities, waste handling facilities, or laboratories, the costs for hand hygiene would depend on the number of employees.  As a result, a smaller facility would have lower total costs.  The cost to individual facilities will also depend on the extent to which workers are currently performing hand hygiene.  If the workers in a given facility are always, or almost always, performing appropriate hand hygiene, the additional costs to comply with a rule based on OSHA's regulatory framework would be low compared to the higher costs in a comparably-sized facility where workers do not currently perform appropriate hand hygiene.
Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that workers in laboratories have the highest baseline compliance rate (practicing proper hand hygiene 80 percent of the time), that workers in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, have the lowest baseline compliance rate (practicing proper hand hygiene 34 percent of the time), and that workers in the remaining settings practice proper hand hygiene about 50 to 60 percent of the time.  The Agency welcomes feedback from the SERs on these preliminary estimates of current compliance.
Food and Cosmetics
Per the regulatory framework, OSHA would require implementation of procedures for restricting, to areas where there is no occupational exposure during provision of direct patient care and/or performance of other covered tasks, activities such as eating, drinking, smoking, applying cosmetics or lip balm, handling contact lenses, and storing food and drink.

OSHA preliminarily concludes that such restrictions are standard practice in all healthcare facilities and in facilities that handle potentially contaminated waste and, therefore, that employers would not incur costs to comply with this provision in a rule as outlined in the regulatory framework.

The Agency is interested in any feedback on this issue the SERs may have to offer.  Do the SERs agree with OSHA's determination that there are no costs associated with this potential provision?  What additional actions, if any, would employers need to take, or what costs might they incur, to comply with this potential provision?

Engineering Controls

Per the regulatory framework, OSHA would require employers to implement procedures to examine existing engineering controls on a regular schedule and to ensure that those controls are maintained or replaced to ensure their effectiveness and thereby provide their intended protections.  OSHA would also require that employers that have healthcare settings with airborne infection isolation rooms (AIIRs) implement procedures for ensuring proper AIIR operation.  These would include procedures for ensuring that each AIIR, associated ducting, and filtration are constructed, operated, and maintained so that they maintain negative pressure, achieve sufficient air changes per hour, properly exhaust contaminated air, and function to prevent or minimize transmission of infectious agents, and for ensuring that, when in use, each AIIR is monitored daily for maintenance of negative pressure.  Finally, in diagnostic, research, and production laboratory facilities, OSHA would require procedures to ensure the appropriate construction, operation, and maintenance (e.g., proper air flow, exhaust air filtration, double access doors, special design requirements for Biosafety Level 3 and 4 facilities) of engineering controls (such as biosafety cabinets (BSCs), laboratory hoods, and other laboratory design and containment measures).

OSHA has preliminarily estimated that certain types of engineering controls currently used to control the spread of infectious agents (e.g., AIIRs, autopsy suites, and BSCs) may need to be upgraded or improved by some establishments to comply with a rule as outlined in the regulatory framework.  The Agency does not anticipate that such a rule would result in the installation of new or additional engineering controls.  And OSHA expects that many of the sectors affected by a rule as outlined in the regulatory framework would not incur costs related to upgrading or improving engineering controls because many facilities do not have these types of controls and would not need them to comply with a rule as outlined in the regulatory framework.

For the purposes of this preliminary analysis, OSHA is estimating the cost of upgrading and maintaining AIIRs, autopsy suites, and BSCs.  These estimates include one-time costs to upgrade or perform major maintenance in order to bring existing AIIRs, autopsy suites, and BSCs into compliance with accepted engineering or other recognized and accepted standards and yearly costs thereafter for facilities to continue to maintain those controls in working order. Under a rule as outlined in the regulatory framework, these potential upgrading and maintenance costs would only be incurred by facilities that (1) have these types of engineering controls and (2) are not currently maintaining those controls to the proper standards.

Based on analyses performed in conjunction with OSHA's proposed rule addressing occupational exposure to tuberculosis (TB), 64 FR 54160 (Oct. 17, 1997), the Agency preliminarily estimates that, for those facilities that would need to do so, there would be a one-time cost of $7,217 to upgrade an AIIR so that it functions properly (e.g., maintains negative air pressure relative to the surrounding areas, completes the recommended number of hourly air exchanges).  This is based on an estimated cost of approximately $48 per square foot to purchase and install material, including ducting, fans, and HEPA filters, in an average isolation room measuring 150 square feet (WCG, 1994, updated to 2012 dollars).  OSHA also preliminarily estimates that it will cost $866 annually for facilities that are not properly maintaining their existing AIIRs to do so (an estimated 12 percent of the cost of upgrading an AIIR).  This maintenance cost would be incurred annually and represents the cost to facilities to properly maintain their AIIRs during a given year.  The provisions of a rule as outlined in the regulatory framework would not require facilities that do not have AIIRs to install them, and OSHA expects that costs associated with upgrading and maintaining AIIRs would only apply to hospitals, and that some percentage of facilities would not incur costs relating to upgrading or maintaining AIIRs because they either do not have AIIRs or are already properly maintaining them.

OSHA also preliminarily concludes that some funeral homes, morgues and mortuaries, and hospitals would need to upgrade their autopsy suites to comply with a rule based on the regulatory framework.  The Agency preliminarily estimates that these upgrades will cost $14,435 per facility, which includes the installation of HEPA filtration, if necessary, and upgrading ventilation systems to achieve adequate negative pressure (WCG, 1994, updated to 2012 dollars) and represents a one-time cost for facilities that would need to bring their existing autopsy suites into compliance with existing engineering standards or other applicable guidelines or specifications.  In addition to those upgrades, OSHA estimates that facilities not currently maintaining their autopsy suites would incur annual maintenance costs of $1,732 annually (estimated at 12 percent of the cost of upgrading an autopsy suite).  OSHA preliminarily concludes that only hospitals, morgues, and mortuaries have autopsy suites and some of these establishments would incur such costs.  The remaining establishments are preliminarily believed to be maintaining their autopsy suites to industry standards.

Finally, OSHA preliminarily concludes that some diagnostic, research, and production laboratory facilities  -  including clinical laboratories which can be located within a hospital  -  would need to upgrade and properly maintain their existing BSCs.  The Agency preliminarily estimates that it would cost $809 initially for a BSC to be upgraded properly and $97 for a BSC to be maintained properly (OSHA, 1997, updated to 2012 dollars).  The initial cost represents a one-time cost for facilities that would need to upgrade or perform major maintenance on their existing equipment in order to bring it into compliance with existing applicable guidelines or standards.  The annual cost would be incurred each year by facilities in order to continue to properly maintain their upgraded equipment.  Establishments whose BSCs are currently being maintained properly would not incur any additional maintenance costs associated with a rule as outlined in the regulatory framework.  OSHA preliminarily concludes that only hospitals and diagnostic, research, and production laboratory facilities will have BSCs.
OSHA summarizes the unit costs associated with engineering controls in Table VI-2, below.

Because of the flexibility of the regulatory framework, a facility with an AIIR that does not want to upgrade and maintain that room would not need to do so as long as the facility does not use the room for isolation purposes.  (However, per the regulatory framework, this facility would need to develop SOPs for the temporary isolation and inter-facility transfer of individuals with suspected or confirmed airborne infectious diseases to facilities with functional AIIRs.)  Likewise, a laboratory that does not wish to upgrade and maintain its BSCs would not need to do so as long as the facility does not use the BSC for infectious agent containment purposes.  Instead, the facility could use the certified BSCs at a different laboratory for certain steps in a procedure they are performing, use alternative containment (such as a fume hood) where appropriate, or redesign experiments to use materials and/or procedures that do not call for containment in a BSC.
Based on the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that most hospitals (83 percent) that have AIIRs properly maintain them.  OSHA also preliminarily estimates that 91 percent of hospitals and 94 percent of laboratory facilities that have BSCs properly maintain them.  Finally, OSHA preliminarily estimates that 83 percent of hospitals and 58 percent of morgues and mortuaries that have autopsy suites properly maintain them.  OSHA considers these estimates to be preliminary and welcomes any feedback the SERs can offer on current compliance.  This feedback would assist OSHA in developing estimates for the proposed rule, if OSHA engages rulemaking.
OSHA also asks the following:
Are facilities or sectors currently using any types of engineering controls that have not been discussed in this section of the SER Background Document to control the spread of infectious agents?
   * Do SERs interpret the provisions as outlined in the regulatory framework as potentially requiring facilities to install new, rather than to upgrade and maintain existing, engineering controls?  For example, do SERs believe that there are instances where a facility's WICP, when written to the specifications in the regulatory framework, would result in those facilities needing to install engineering controls (either those listed above or those not identified by OSHA) to comply with a rule as outlined in the regulatory framework?
Administrative and Work Practice Controls
Per the regulatory framework, OSHA would require that employers implement procedures for the use of administrative and work practice controls to minimize transmission of, and infection by, infectious agents.  As discussed below, OSHA has preliminarily concluded that some administrative controls and most work practice controls necessary to minimize transmission of, and infection by, infectious agents can be achieved through modification of current practices and that compliance with a rule as outlined in the regulatory framework would result in no additional costs to employers.  As always, the Agency welcomes feedback from the SERs on this determination.  Are there controls  -  either administrative or work practice - that OSHA has not considered that would need to be implemented to comply with a rule based on the regulatory framework?  If so, would these controls result in additional time or materials costs to the affected facilities?

Per the regulatory framework, administrative controls would include, but are not limited to: promoting and providing vaccinations; enforcing the exclusion of ill employees from the workplace; setting up triage stations and separate areas for patients with suspected or confirmed infectious diseases when they enter the facility; and assigning dedicated staff to patients with suspected or confirmed infectious diseases to minimize the number of employees exposed.  While OSHA preliminarily concludes that, under a rule as outlined in the regulatory framework, there would be costs associated with promoting and providing vaccinations and enforcing the exclusion of ill employees from the workplace, OSHA discusses these costs later in this section of the SER Background Document.  The Agency preliminarily concludes that setting up triage stations and separate areas for patients with suspected or confirmed infectious diseases when they enter a healthcare facility, and implementing administrative controls related to staffing, may require modifications in the way tasks are performed, but should not take additional time or resources.

Per the regulatory framework, work practice controls would include, but are not limited to, performing tasks in a manner that minimizes generation of droplets or aerosols of infectious agents and practicing appropriate hand hygiene and respiratory hygiene/cough etiquette.  See the discussion, earlier in this section of the SER Background Document, regarding OSHA's preliminarily estimates of the costs associated with hand hygiene.  OSHA preliminarily concludes that other work practice controls can be implemented through modifications in current practices and that these modifications would not require additional time or materials over current practices.

Personal Protective Equipment
Per the regulatory framework, OSHA would require that employers implement procedures to provide, make readily accessible, and ensure that each employee uses appropriate PPE (such as, but not limited to, gloves, gowns, laboratory coats, face shields, facemasks, and respirators).  Compliance with the PPE provisions described in the regulatory framework would involve the selection of the correct type of PPE for each specific type of situation, the implementation of procedures for the correct donning and removal of PPE, the provision of designated containers for disposable PPE or reusable PPE, and the implementation of procedures for the laundering of PPE (e.g., lab coats, scrubs).  The potential costs for a provision on developing (as opposed to implementing) PPE guidelines (with the exception of developing and establishing a respiratory protection program) are covered by the earlier discussion of the costs associated with developing a WICP, and any training related to the proper selection or use of PPE is addressed as part of the training discussion later in this section of the SER Background Document.  The potential costs associated with respiratory protection programs are addressed below, under the heading "Respiratory Protection."
The total cost to establishments to provide PPE would vary based on the type of infectious agents that may be encountered in the workplace, and the number of encounters workers will have with sources of infectious agents during a given period.  In settings where employees do not routinely see patients with infectious diseases, facilities could have extremely low costs for this potential provision.  Such employers could reduce costs even more by further reducing employee exposure.  For instance, if dentists' offices or ophthalmologists' offices require that patients displaying flu-like symptoms or symptoms of a respiratory illness reschedule their appointments, the offices would not need to provide PPE as droplet and/or airborne precautions for their workers (although they would still need to provide PPE to institute the Standard Precautions that would be required under a rule as outlined in the regulatory framework and to comply with OSHA's Bloodborne Pathogens standard (to the extent that standard is applicable)).
The cost of implementing SOPs for PPE provision and use will also vary by the size of a facility and by the number of patients that the facility sees.  A small practice with few employees and low patient volume may have very low costs for PPE while a large hospital with hundreds of workers and patients on any given day may have much higher costs for PPE.  Standard Precautions should be used in all healthcare settings. In ambulatory care settings, many patients who are more severely ill with symptoms for which transmission-based precautions are appropriate are routinely transferred to hospitals or other similar settings. The additional gloves required for transmission-based precautions, therefore, would not be needed as often in ambulatory care settings; as a result, the overall cost of gloves would be lower in these facilities.
While the per-facility cost of implementing the SOPs for employer's providing PPE and the use of PPE will vary by facility type and size, the per-unit cost of PPE should be comparable across establishments and work settings.  OSHA preliminarily estimates that a pair of disposable gloves costs $0.16 (Staples.com, 2013) and would need to be donned by each worker prior to contact with each new patient and any time gloves become visibly soiled or before contact with potentially infectious materials.  Facemasks (e.g., surgical masks), which are needed for protection against suspected or confirmed cases of droplet transmissible diseases, cost $0.13 per piece (GlobalCareMarket.com, 2013), and can be worn by an employee until visibly soiled (one surgical mask estimated to be used per work shift).  N95 respirators, which are needed for protection against airborne transmissible diseases and during aerosol generating procedures, can be purchased for $0.33 each (Amazon.com, 2013), and, like facemasks, can be worn until visibly soiled, (one N95 respirator estimated to be used per work shift).  Disposable gowns cost $2.42 each (Grainger, 2013a) and need to be used when workers are working inside isolation rooms or when there is risk of the worker's skin or clothing becoming contaminated (e.g., during aerosol generating procedures, during some laboratory procedures, or while handling infectious waste or laundry).  Disposable face shields can be purchased for $4.55 (Grainger, 2013b) and are needed mainly when workers are potentially exposed to droplet spray and when workers are performing aerosol-generating activities in settings where direct patient care is provided and where other covered tasks (such as medical equipment reprocessing or in laboratories) are performed.  Finally, protective eyewear can be purchased for $2.05 per pair (Uline.com, 2013) and is used primarily when workers are potentially exposed to splashes or sprays and when performing aerosol-generating activities.  Table VI-3 below details the estimated per-unit costs of PPE.

Employers will only need to provide PPE appropriate to their facility.  If a facility does not perform aerosol generating procedures or have patients in isolation rooms, that facility would not need to provide PPE needed for those circumstances.
According to the Draft Report on Current Compliance, and as shown in Table VI-10, employees in laboratories are estimated to be using PPE, where appropriate, 86 percent of the time, with employees in hospitals and dentists' offices also estimated to have a relatively high level of compliance at 76 percent each.  Employees in "other occupational settings," including morgues and mortuaries and waste handling, and laundry services, are estimated to be using PPE, when appropriate, just 35 percent of the time, and workers in the remaining settings are estimated to be using appropriate PPE between 40 and 60 percent of the time.
In addition to welcoming feedback on both unit costs and current levels of compliance, OSHA is interested in the number of encounters a worker would have in a given time period that would require the use of PPE, the number of items of PPE used in a given time period (for example, how many pairs of gloves would a worker need during a work shift), and the number of additional encounters that would require the use of PPE under a rule based on the regulatory framework (for example, how many additional times would a worker need to use gloves, above and beyond what is currently used, as a result of a rule based on the regulatory framework).  The Agency welcomes any information that would assist in estimating the additional PPE needs that would result from the promulgation of a rule as outlined in the regulatory framework that would be above the preliminary compliance rates shown above.

Respiratory Protection
This section presents potential costs for establishing a respiratory protection program (other than costs for providing respirators, which have been described above).  Under a rule based on the regulatory framework, employers would generally have to develop, establish, and implement procedures that are consistent with OSHA's Respiratory Protection standard (29 CFR 1910.134).  At present, OSHA has not made any determination about the extent to which compliant respiratory protection programs are currently in place at establishments potentially affected by a rule based on the regulatory framework, but the Agency presents its preliminary estimates, based on the Draft Report on Current Compliance, at the end of the present discussion on respirators.

According to OSHA's Respiratory Protection standard, employers whose workers are required to wear respirators during the course of their job duties must establish a written respiratory protection program (OSHA, 1998).  A respiratory protection program must contain the following elements:
   * Procedures for selecting respirators;
   * Medical evaluations of employees required to use respirators;
   * Fit testing procedures;
   * Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations;
   * Procedures and schedules for cleaning, disinfecting, storing, inspecting, repairing, discarding, and otherwise maintaining respirators;
   * Procedures to ensure adequate air quality, quantity, and flow of breathing air for atmosphere-supplying respirators;
   * Training of employees in the respiratory hazards and proper use of respirators; and
   * Procedures for regularly evaluating the effectiveness of the program.

In this section, OSHA is evaluating the potential costs for program establishment and implementation, medical evaluation, fit testing, and training.  OSHA believes, at this time, that facilities subject to a rule as outlined in the regulatory framework would use disposable N95 respirators only, and therefore would not need to clean or disinfect their respirators, nor would they need to ensure adequate air quality, quantity and flow of breathing air, since they would not be using atmosphere-supplying respirators.  Potential recordkeeping costs are addressed, separately, in the discussion of potential recordkeeping costs.

Based on OSHA's Respiratory Protection information collection request (ICR), OSHA estimates that an infection control professional at a high risk establishment would take eight hours to develop a written respiratory protection program initially, and four hours annually to maintain the program (OSHA, 2011).  And the Agency estimates that an infection control professional at a low risk establishment would take four hours to develop a written program initially, and two hours to maintain the program annually (OSHA, 2011).  As stated below, OSHA expects that the per-facility cost to develop and implement a respiratory protection program will vary by setting and facility size.  While OSHA has not currently made any determination as to which settings and facilities potentially affected by a rule based on the regulatory framework would be high risk and which would be low risk, the Agency welcomes any feedback the SERs may have on the issue.

The Respiratory Protection standard requires employers to provide a medical evaluation to determine the employee's ability to use a respirator before the employee is fit tested or required to use the respirator in the workplace (OSHA, 1998).  The medical evaluation may be done in the form of a medical questionnaire that is included in an appendix to the Respiratory Protection standard.  The questionnaire is completed by the employee and reviewed by a PLHCP for certain answers that would indicate that the employee needs to be further evaluated by a medical professional.  Although some workers who undergo the medical evaluation would require a follow-up medical examination that must include any medical tests, consultations, or diagnostic procedures that a PLHCP deems necessary, most initial medical evaluations do not require a follow-up medical examination.  Moreover, employers must provide additional medical re-evaluations to workers under specific conditions, such as where: a symptom is displayed by the employee; there is a change in workplace conditions that may result in a substantial increase in the physiological burden on the employee; the respiratory protection program administrator or a manager or a PLHCP notices a need for reevaluation; or fit testing reveals an issue (OSHA, 1998).  If a worker must travel to a doctor's office or hospital to receive a medical evaluation or re-evaluation, or a follow-up medical examination, OSHA preliminarily estimates that the employer would incur costs equal to 30 minutes of travel time, plus $5.00 in travel costs, for that worker.  The total unit cost of this travel time in dollars would depend on the wage of the affected worker.

For this analysis, OSHA is preliminarily estimating two different types of unit costs associated with the medical re-evaluation requirement of the Respirator Protection standard.  OSHA preliminarily believes that an employer would accrue the first type of unit cost when there is a change in work conditions, such as the introduction of a new hazard or a new process, or a switch to a different type of respirator.  In this case, a medical re-evaluation will consist of the worker repeating the initial medical evaluation (i.e. filling out a questionnaire) and potentially undergoing the same type of medical examination as a worker who is newly required to wear a respirator.  OSHA also preliminarily believes that an employer would accrue the second type of cost when a worker has been given an initial medical evaluation (and a possible follow-up medical examination), but a new or worsening health condition requires that worker to receive an additional follow-up medical examination with a PLHCP, and to potentially undergo additional tests or diagnostic procedures.

Based on the Respiratory Protection ICR, OSHA preliminarily estimates that: the questionnaire associated with the initial medical evaluation (or with the re-evaluation necessitated by a change in work conditions)  requires 15 minutes of the worker's time to complete and five minutes for a PLHCP to review; and any follow-up medical examination associated with the initial medical evaluation (or with the re-evaluation necessitated by a change in work conditions) requires one hour of the worker's time, and costs, on average, $294.75 per worker, which includes the cost of any required tests, consultations, or diagnostic procedures, as well as the cost of the examination (OSHA, 2011).

The Agency also preliminarily estimates that a medical re-evaluation required by a new or worsening health condition will take 30 minutes of a worker's time, and that any associated follow-up medical examination that involves a visit with a PLHCP will cost $138 (FAIR Health, 2013; AMA, 2008; AHRQ, 2011a).  OSHA preliminarily estimates that the follow-up medical examination associated with this type of re-evaluation is less burdensome than the initial follow-up medical examination (and less burdensome than the re-evaluation necessitated by a change in work conditions) because the medical examination is an evaluation of an already identified issue or (in the case of a potential issue not identified during the initial evaluation) a less serious issue that does not need extensive testing.

The Respiratory Protection standard requires that, before a worker is required to use a respirator with a negative or positive pressure tight-fitting facepiece, the employee must be fit tested with the same make, model, style, and size of respirator that will be used (OSHA, 1998).  OSHA estimates, based on the Respiratory Protection ICR, that fit testing performed by an employer takes 30 minutes of the worker's time and 30 minutes of the fit tester's time, and that the process uses $1.15 worth of materials (OSHA, 2011).  Some percentage of workplaces may be able to obtain fit testing services at no cost from the respirator manufacturer, and, in such cases, each worker would take 30 minutes to complete a fit test.  Furthermore, some workplaces may opt to have fit testing performed by an outside contractor, and in such cases, OSHA estimates the fit testing would take 30 minutes of the worker's time and would cost $76.68 per worker who is fit tested (OSHA, 2011).

 Table VI-4 below summarizes the potential costs, discussed above, that are associated with respiratory protection, including the estimated costs of the written respiratory protection plan, the medical evaluation and examination, and fit testing.

Like other elements of a rule based on the regulatory framework, OSHA expects that the per-facility cost to develop and implement a respiratory protection program will vary greatly by setting and facility size. For example, a rule as outlined in the regulatory framework would add no respirator-related costs for establishments that do not normally see patients who are seeking treatment for the type of infectious diseases that would require respiratory protection (such as the majority of physical therapist or podiatrist offices).
Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that workers in laboratories have the highest estimated baseline use of respirators where airborne infection is possible, about 85 percent of the time, and workers in hospitals are estimated to be using respirators appropriately 64 percent of the time.  Four settings have estimated compliance rates for respirator use below 40 percent.  These include other "occupational settings," including morgues and mortuaries and waste handling and laundry services (26 percent), physicians' offices (29 percent), other ambulatory care settings (33 percent), and dentists' offices (38 percent).
Also, per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that 86 percent of laboratories are providing initial fit testing and 57 percent are providing annual fit testing.  Similarly, 84 percent of hospitals are estimated to be providing initial fit testing and 61 percent are estimated to be providing annual fit testing.  Physicians' offices and establishments in "other occupational settings" are estimated to be the least compliant with these provisions of the Respiratory Protection standard, with baseline compliance rates for initial fit testing of 23 and 17 percent, respectively, and for annual fit testing of 14 and 15 percent, respectively.  Establishments in the remaining settings are estimated to have baseline compliance rates of about 40 percent for initial fit testing, and between 15 and 30 percent for annual fit testing.
Finally, per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates the levels of current compliance with the Respiratory Protection standard's requirement to provide medical evaluations to employees prior to fit-testing.  According to these estimates, 84 percent of hospitals, 71 percent of laboratories, and only 15 percent of establishments in "other occupational settings," are providing medical clearance to respirator-wearing employees.  No other setting is estimated to have a baseline compliance rate of more than 38 percent (long term care and nursing homes), with most estimated to have a baseline compliance rate of between 20 and 27 percent.
OSHA welcomes any feedback the SERs may have on these preliminary estimates of current compliance.
Decontamination
Per the regulatory framework, OSHA would require implementation of procedures for routine and targeted decontamination of contaminated materials (i.e., contaminated items and/or surfaces) in the work setting that could be a source of occupational exposure.  Decontamination encompasses cleaning, disinfection, and sterilization.

The regulatory framework does not prescribe any particular cleaning, disinfection, or sterilization methods that employers would be required to use, nor does OSHA intend to specify cleaning products or cleaning schedules.  OSHA would require that employers generally be required to develop and implement decontamination procedures that are consistent with recognized and generally accepted good infection control practices.  Employers would also need to follow EPA hazardous waste regulations (which are discussed in this SER Background Document in Section VII, "Description of Any Duplicative, Overlapping, or Conflicting Rules").

OSHA preliminarily concludes that appropriate decontamination procedures could be implemented through modifications in current practices and these modifications would not require additional time or materials over current practices.  Studies have found no correlation between the amount of time spent cleaning a room and the thoroughness of the cleaning (Rupp, 2013; Carling, 2008).  This suggests that training workers to correctly disinfect rooms and equipment is an effective way to improve the thoroughness of decontamination procedures without devoting extra time to decontamination.  Additional training (discussed later in this section of the SER Background Document) would provide workers with the background knowledge and procedures necessary for them to appropriately decontaminate contaminated items and surfaces.

OSHA believes that the flexibility of the approach presented in the regulatory framework would be key to keeping costs of complying with this provision at a minimum (or, as the Agency preliminarily estimates, no greater than current costs of cleaning and decontamination).  Indeed, the flexibility of the regulatory framework would permit employers to reduce current costs, as less expensive decontamination products or methods are developed.  Since the regulatory framework does not dictate what cleaning products must be used or how cleaning must be done, facilities could choose less costly disinfection products or methods so long as those products or methods are consistent with recognized and generally accepted good infection control practices.
Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that 71 percent of hospitals and 71 percent of laboratories properly clean and disinfect surfaces, giving these settings the highest baseline compliance rates for this provision of the regulatory framework.  Only an estimated 25 percent of facilities in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, properly clean and disinfect surfaces, giving these settings the lowest baseline compliance rates.  Facilities in other ambulatory care settings and physicians' offices have estimated baseline compliance rates of 34 and 35 percent, respectively, and facilities in the remaining settings have estimated baseline compliance rates of between about 40 and 50 percent.
OSHA welcomes any feedback on these estimates.  Do you agree with OSHA's preliminary finding that, with adequate training, facilities not currently cleaning and disinfecting surfaces properly could do so in the same amount of time and with the same materials they are currently using?  And do you agree with OSHA's preliminary estimates of baseline compliance?
Handling, containerization, transport, or disposal of contaminated materials

Per the regulatory framework, OSHA would require employers to implement procedures to ensure that contaminated materials that could be a source of occupational exposure to infectious agents are properly containerized and labeled in order to prevent leaks and minimize worker contact with infectious materials during collection, handling, processing, storage, transport, shipping, or disposal.

OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) also contains requirements related to the safe handling, processing, storage, transport, shipping and disposal of contaminated materials.  The Agency does not expect that most employers would incur additional costs related to handling, processing, storage, transport, shipping or disposal of contaminated materials above the costs attributed to the Bloodborne Pathogens standard.  In addition, a number of establishments are already following the Department of Transportation's (DOT's) Hazardous Materials Regulations that involve requirements for the storage, transport and shipping of infectious or potentially infectious agents (these requirements are discussed in this SER Background Document in Section VII, "Description of Any Duplicative, Overlapping, or Conflicting Rules"), as well as applicable state-level requirements on transporting hazardous materials.

The Agency is interested in whether, in the opinion of the SERs, firms would incur additional costs in complying with this provision of the regulatory framework.  Do the SERs agree with the Agency's preliminary determination that by following current rules, an employer would be in compliance with this provision?  Are there additional potential costs that OSHA has failed to take into consideration?

Exposure incidents

Per the regulatory framework, OSHA would require establishments to investigate the circumstances surrounding each exposure incident, including a determination of the cause of the incident and whether existing policies, procedures, or training need to be revised to prevent future exposure incidents.  OSHA preliminarily estimates that an exposure incident investigation would take, on average, 30 minutes.  This average is meant to take into account both very simple investigations, which may take far less than 30 minutes (because, for example, the exposure incident involves an easily identified cause and existing policies, procedures, and training are readily determined to be adequate), and more complex investigations that require more than 30 minutes to fully investigate.  OSHA has not made any determination as to the number of exposure incidents that facilities may need to investigate in a given year, but the Agency welcomes feedback from the SERs on the question.

Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that hospitals are currently investigating exposure incidents 82 percent of the time, while laboratories are estimated to be doing so 85 percent of the time.  Dentists' offices, physicians' offices, and employers in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, are estimated to be currently investigating exposure incidents about 30 percent of the time.  OSHA welcomes any feedback the SERs may have to offer on these estimates of current levels of compliance.

Signage and Labeling/Color-coding
Per the regulatory framework, OSHA would require employers to implement procedures for the use of signage and labeling/color-coding to convey an appropriate hazard warning to workers throughout the employer's work settings.  In addition, under the regulatory framework, OSHA would require employers to implement procedures for the use of signage and labeling/color-coding to convey an appropriate hazard warning to workers outside the employer's work settings in cases where the workers could come in contact with contaminated materials that originated in the employer's workplace (e.g., dirty linens) during collection, handling, processing, storage, transport, shipping, and disposal activities.
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) also contains requirements related to signage and labeling/color-coding.  The Agency does not expect that most employers would incur additional costs related to signage and labeling/color-coding above the costs attributed to the Bloodborne Pathogens standard.  OSHA therefore preliminarily concludes that where employers comply with the Bloodborne Pathogens standard, the costs of this potential provision will be negligible.  In addition, a number of establishments are already following signage and labeling procedures in accordance with DOT's hazardous materials requirements (these requirements are discussed in this SER Background Document in Section VII, "Description of Any Duplicative, Overlapping, or Conflicting Rules").

OSHA welcomes feedback from the SERs on the determination that compliance with this potential provision will not result in additional costs to employers.  Do the SERs agree with this determination, or do the SERs feel that OSHA has failed to consider costs associated with this potential provision?  If the SERs feel that the Agency is incorrect in this determination, how would current practices need to change for a firm to comply with this potential provision?

         b. Implementation of Standard Operating Procedures for Direct Patient Care

In addition to the general SOPs discussed above, per the regulatory framework, OSHA would require the development and implementation of SOPs that are specific to direct patient care.  This section discusses potential provisions that are specific to direct patient care.  As always, OSHA welcomes any feedback the SERs have on the preliminary determinations presented in this section.  Do you agree with OSHA's preliminary conclusions?  Are there any procedures that OSHA has not considered that would need to be implemented as a result of the provisions in the regulatory framework that would result in costs  -  either time or materials?

Patient scheduling and intake/admittance

For employers that conduct patient scheduling and intake/admittance, OSHA would require implementation of SOPs to promptly identify individuals with suspected or confirmed infectious diseases in order to initiate appropriate infection control practices.  OSHA preliminarily concludes that these procedures could be achieved by modification of current work practices and therefore would not require any additional time for affected establishments to comply.

Procedures for implementing SOPs for standard, contact, droplet, and airborne precautions

OSHA would require implementation of SOPs for standard, contact, droplet, and airborne precautions.  OSHA analyzed the major elements of these forms of precautions under the general SOP implementation discussed above.  For example, the previous section details OSHA's estimated potential costs for the use of PPE (including respirators), hand hygiene, the maintenance of existing engineering controls, and work practice controls to minimize the generation of aerosols during certain procedures.  The Agency has not identified any additional activities that potentially affected establishments would need to undertake to comply with these provisions of the regulatory framework, but OSHA welcomes any feedback from the SERs on this issue.

Procedures for patient transport

OSHA has preliminarily concluded that affected establishments would not incur costs associated with implementing SOPs for patient transport, which OSHA would require, per the regulatory framework.  The Agency believes that facilities that would need to transfer patients under this potential requirement (mainly hospitals, nursing homes or long term care facilities, and embedded clinics in prisons) are already meeting this potential requirement.  Any other facility where direct patient care is provided would not be caring for patients who would need this type of transport.  As always, OSHA welcomes feedback on this preliminary determination.  Do the SERs believe that this potential provision would require patient transport above what is currently standard practice?

Medical surge procedures

OSHA has not yet examined the costs of implementing medical surge procedures.  For those employers who are not yet implementing adequate procedures, there would certainly be planning costs, as well as costs for the implementation of procedures for surge conditions that will depend on the nature of the surge situation.  OSHA welcomes SER input on the costs associated with these activities.

         c. Implementation of Standard Operating Procedures for Other Covered Tasks

In addition to the general SOPs discussed above, per the regulatory framework, OSHA would require SOPs that are specific to other covered tasks.  This section discusses potential provisions that are specific to other covered tasks.  As always, OSHA welcomes any feedback the SERs have on the preliminary determinations presented in this section.  Do you agree with OSHA's preliminary conclusions?  Are there any procedures that OSHA has not considered that would need to be implemented as a result of these potential provisions that would result in costs  -  either time or materials?

Procedures for handling and intake of contaminated materials and procedures for the use of necessary control measures

Similar to the discussion in the section on general SOPs about handling contaminated materials, OSHA does not expect that most employers would incur additional costs in conjunction with this provision of the regulatory framework.  OSHA anticipates that any establishments in the scope of a rule based on the regulatory framework would currently be familiar with, and have procedures for, handling and intake of contaminated materials, and for using necessary control measures.

Engineering controls

OSHA discussed the potential costs associated with upgrading and maintaining engineering controls in its discussion of potential costs for general SOPs, above.

Measures necessary to address uncontrolled releases of infectious agents, including mitigation of such releases and prompt reporting of such incidents to appropriate authorities

Per the regulatory framework, this provision would be specific to diagnostic, research, and production laboratory facilities.  The Agency did not identify any additional potential costs associated with implementing measures to address uncontrolled releases of infectious agents, but welcomes any additional information the SERs can provide on the issue.  In OSHA's preliminary estimation, these measures would rarely need to be implemented, but would involve (1) planning for such circumstances, which, the Agency preliminarily believes, affected firms are already doing, and (2) training workers on these measures.  OSHA addresses any training costs associated with this potential requirement later in this section of the SER Background Document.

Do the SERs agree with OSHA's preliminary determination?  Would the implementation of this draft provision of the regulatory framework result in additional costs that the Agency has not considered?

   3.          Medical screening, surveillance, and vaccination

The following sections address the implementation of occupational health services that could be required by OSHA, per the regulatory framework.  These services could include vaccinations, medical screening and surveillance, medical evaluation and follow-up, maintenance of exposure incident records, and medical removal protection.

Vaccination

Per the regulatory framework, OSHA would require employers to make available to their employees vaccinations that are consistent with recognized and generally accepted good infection control practices relevant to the occupational exposures encountered during the job tasks of the employee.  With the exception of employees in research and production laboratory facilities, employers could be required to make available to their employees, at a minimum, the following vaccinations:
            *       Influenza (Seasonal and Pandemic);
            *       Measles, Mumps and Rubella (MMR);
            *       Tetanus, Diphtheria, and Pertussis (Tdap);
            *       Varicella; and
            *       Any other vaccination(s) that is required by the employer's WICP, or determined by a PLHCP to be medically appropriate for a particular worker (e.g., the meningococcal vaccine.)

OSHA believes that making the specified vaccinations available would generally protect affected workers from the infectious agents to which they have occupational exposure.  However, employers of employees in research and production laboratory facilities may be required to make available to those employees only those vaccinations that the employer determines are relevant to their work settings.  For example, workers in a research laboratory handling one infectious agent only (e.g., Neisseria meningitidis bacteria) would be offered one vaccination only (in the example, the meningococcal vaccine) because they are not working with other infectious agents.
As outlined in the regulatory framework, OSHA could exempt an employer from offering a vaccination to a worker where the employer has documented that the worker has already received the vaccination, antibody testing reveals immunity, or the vaccine is contraindicated for medical reasons.  OSHA preliminarily estimates the cost per vaccine as shown in Table VI-5 below.

In addition to the cost of the vaccine, OSHA preliminarily estimates that it would take 5 minutes of a worker's time to receive a vaccine on-site, plus 5 minutes of a PLHCP's time to administer each vaccine.  Most workers potentially affected by a rule based on the regulatory framework would be able to receive a vaccine at their worksite, but if a worker must travel off-site to receive a vaccine, OSHA preliminarily estimates that it would take 30 minutes of his or her time plus $5.00 in travel costs.

Like many other elements of a rule based on the regulatory framework, the per-facility cost to make vaccinations available would vary based on the size and type of facility.  OSHA delineated specific vaccines in the regulatory framework (influenza, MMR, Varicella, and Tdap) because OSHA preliminarily believes that employers in most settings would need to make these vaccines  -  and only these vaccines  -  available to the majority of their employees.

Per the regulatory framework, an employer would be required to ensure that an employee fill out a vaccine declination form when that employee declines a vaccination.  The Agency preliminarily estimates that it would take two minutes of a worker's time to decline a vaccine and five minutes of an administrative assistant's time to process and file such a form.
Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that 85 percent of hospitals currently offer their workers the full complement of CDC/ACIP recommended vaccines and 72 percent of laboratories offer their workers the full complement of CDC/NIH BMBL recommended vaccines.  About 30 percent of establishments in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, dentists' offices, and physicians' offices, and about 40 percent of establishments in the remaining settings, currently offer their workers the full complement of recommended vaccines.
Also per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that, for most settings except hospitals, a higher percentage of establishments make vaccines available in accord with state-level vaccine requirements that are less extensive (as opposed to the more extensive ACIP/CDC or CDC/NIH BMBL recommendations).  OSHA preliminarily estimates that about 50 percent of physicians' offices and dentists' offices (the low end of baseline compliance), and about 60 to 80 percent of establishments in the remaining settings, offer workers vaccines in accord with state-level vaccine requirements.
OSHA welcomes feedback from the SERs on these preliminary estimates of current compliance.
Medical Screening and Surveillance
Per the regulatory framework, OSHA would require employers to provide medical screening and surveillance to their employees who have occupational exposure during the provision of direct patient care or the performance of other covered tasks.  The costs of medical screening and surveillance for each establishment, like many other provisions in the regulatory framework, would depend largely on the size of the establishment.  A small provider with few employees and low turnover would incur minimal costs, while a large provider with hundreds of employees and high turnover would incur higher total costs, to comply with this provision.
Furthermore, the flexibility inherent in the regulatory framework would allow each employer to comply with the provision in a manner appropriate for their individual facility.  As such, employers could choose a less costly method of medical screening and surveillance so long as the chosen method is effective.
For example, medical screening could take the form of a pre-placement "health inventory" that determines immunization status and obtains histories of any conditions that might predispose personnel to acquiring or transmitting infectious diseases.  Medical surveillance could also encompass initial and yearly TB testing.  OSHA addresses the potential costs associated with employees who have a positive result on a TB screening test in the following section on medical follow-up and medical removal protection.
OSHA preliminarily estimates that medical screening that includes a questionnaire filled out by new employees would take 10 minutes of time to complete.  And the Agency estimates that reviewing and verifying the information in the questionnaire with a PLHCP would take an additional 15 minutes of the employee's time plus 15 minutes of a PLHCP's time.  Workers who need to travel to an off-site location to complete their medical screening would incur an estimated additional 30 minutes of travel time plus $5.00 in travel costs.  The total unit cost of this screening in dollars would depend on the wage of the affected worker.
Under a rule as outlined in the regulatory framework, an employer whose WICP requires that it perform a TB test on its workers may choose to obtain a basic medical history and administer a TB test at the same time.  OSHA preliminarily estimates costs for these procedures based on the payment to a medical provider for conducting medical screening and performing testing services, as well as employee time needed to undergo these procedures (including employee time associated with having a test read by a PLHCP, if applicable).  Based on analyses conducted in conjunction with OSHA's proposed rule addressing occupational exposure to TB, OSHA preliminarily estimates that the medical screening portion of these procedures would cost $27, and, factoring in this $27 cost, that performance of medical screening and administration of a TB test at the same time would: (1) require 1 hour of the employee's time and cost $70, if the employee is administered a single step TB test; or (2)  require 1.5 hours of an employee's time and cost $113, if the employee is administered a two-step TB test; or (3) require 30 minutes of an employee's time and cost $326, if the employee is given an IGRA (Interferon Gamma Release Assay) test (OSHA, 1997, updated to 2012 dollars, FAIR Health, 2013).  OSHA preliminarily estimates that an IGRA costs $298.94 versus $43 for a single step skin test and $86 for a two-step skin test  -  but some employers may opt for the IGRA due to convenience because the IGRA can be administered in one visit (FAIR Health, 2013).  Workers who need to travel to an off-site location to complete their medical screening plus TB test would incur an estimated additional 30 minutes of travel time plus $5.00 in travel costs.
OSHA also preliminarily estimates costs associated with an employee undergoing a TB test alone (without medical screening at the same time).  As above, OSHA preliminarily estimates costs for a TB test alone based on the payment to a medical provider for performing testing services, as well as employee time needed to undergo the test (including employee time associated with having the test read by a PLHCP, if applicable).  OSHA preliminarily estimates that administration of a TB test alone would: (1) require 1 hour of the employee's time and cost $43, if the employee is administered a single step TB test; or (2) require 1.5 hours of an employee's time and cost $86, if the employee is administered a two-step TB test; or (3) require 30 minutes of an employee's time, and cost $298.94, if the employee is given an IGRA (FAIR Health, 2013).  Workers who need to travel to an off-site location to complete their TB test would incur an estimated additional 30 minutes of travel time plus $5.00 in travel costs.
Although full-pre-placement physical examinations would not be required by a rule as outlined in the regulatory framework, OSHA preliminarily estimates that establishments who choose to provide full pre-placement physical examinations to their employees would incur costs equivalent to one hour of the employee's time plus an additional $175, representing payment to a medical provider for testing services (OSHA, 1997, updated to 2012 dollars).  Workers who need to travel to an off-site location to complete their physical would incur an estimated additional 30 minutes of travel time plus $5.00 in travel costs.
OSHA summarizes the potential costs associated with the potential requirements for medical screening and surveillance in Table VI-6 below.  All potential costs associated with recordkeeping are addressed in the recordkeeping discussion later in this section of the SER Background Document.

Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that hospitals currently provide pre-placement screenings (either in the form of a health inventory questionnaire or a full physical exam) to 70 percent of workers, and diagnostic testing to 90 percent of workers receiving such screenings.  Three settings (long term care and nursing homes, home healthcare agencies, and laboratories) are preliminarily estimated to provide pre-placement medical screenings to roughly 50 percent of workers.  Laboratories are estimated to provide diagnostic testing to 71 percent of the workers being screened.  And OSHA estimates that long term care facilities and nursing homes and home healthcare agencies provide diagnostic testing to about 45 percent of screened workers.  OSHA preliminarily estimates that in the remaining settings employers provide pre-placement medical screenings to between 10 percent and 19 percent of workers, with diagnostic testing provided to between 17 percent and 41 percent of workers receiving screens.  OSHA welcomes any feedback or additional information the SERs may have on these preliminary estimates of current compliance.

Medical Evaluation, Follow-up, and Medical Removal Protection
Per the regulatory framework, OSHA would require that the employer make available to a worker a confidential medical evaluation and appropriate follow-up, either after a referral from a medical screening or surveillance program (provided a PLHCP has determined that the medical evaluation and appropriate follow-up is necessitated by a workplace exposure, as opposed to a non-workplace exposure), or after a report of an exposure incident.  OSHA would also require that a confidential medical evaluation and appropriate follow-up after an exposure incident include the following elements: the route(s) and circumstances of the exposure; documentation of the source of the exposure (unless the employer can establish that identification is not feasible or prohibited by law); baseline testing; post-exposure prophylaxis and treatment; appropriate counseling; evaluation of reported illnesses that may be attributable to exposure; and, as necessary, recommendations for job modifications or restrictions or for precautionary removal of the employee from the workplace.  Finally, except for most cases of occupational exposure to the common cold or influenza, OSHA would require medical removal protection benefits, i.e., that, an employer pay the total normal earnings and maintain the seniority, rights, and benefits of an employee removed from the job or otherwise medically limited as a result of an exposure incident.
For the purposes of this SER Background Document, OSHA preliminarily estimates the full unit costs of diagnosing and treating a select few workplace acquired infectious diseases, as well as the medical restriction times associated with the infectious diseases.  This means that OSHA will be discussing the potential costs of any relevant drug therapies, recommended post-exposure vaccines, any doctor's visits or testing necessary to diagnose a suspected infectious disease, any treatments for the disease, and any recommended days of medical restriction.
Employers would only be required to provide medical removal protection for as long as an employee is infectious.  In most cases of occupationally-acquired infections, the worker is treated as an outpatient, and, the duration of medical removal protection would generally vary, depending on the disease (see, for example, discussion of influenza, below).   In cases where a worker is hospitalized as a result of a workplace-acquired MRSA infection, OSHA has preliminarily estimated that once that worker is released from the hospital, he or she is usually no longer infectious and therefore no longer subject to medical removal protection.  Because of this assumption, days of hospitalization for MRSA (where relevant) are assumed to be equal to days of work restriction subject to medical removal protection coverage.  Cases of TB will require that medical removal protection be provided for three to four weeks in addition to any time the worker would be hospitalized.
This section will not be deriving a single estimate for the cost of post-exposure prophylactic treatment or a total estimated cost for treating a given case of an infectious disease.  It also does not estimate how many cases may be expected in a given year, or how many workers may potentially need post exposure prophylaxis or medical evaluation, follow-up or medical removal protection.
The total, per-establishment costs of these potential provisions are largely dependent on the number of employees an establishment has and on the number and type of infectious diseases to which employees in that establishment have occupational exposure.  Similar to many OSHA standards, it would not be uncommon for some facilities to have years in which no workers become ill as a result of a workplace exposure.  Some facilities are unlikely to ever see a patient with many of the diseases that would be covered under a rule as specified in the regulatory framework  (e.g., it would be unlikely that podiatrists and optometrists would see patients with active TB or an infection with Clostridium difficile).  Finally, many infectious diseases are relatively uncommon in the United States, and only a handful of facilities would even see one case in a given year.
The estimates presented below also do not take into account health insurance or workers' compensation coverage, both of which may reduce the actual burden to the employer of treating a case of an occupationally acquired infectious disease.  OSHA has addressed this issue in past rulemakings (in the ergonomic rulemaking, for example) by discounting the cost to employers to account for insurance or workers' compensation; thus, the Agency is aware of the issue but is still in the process of determining how to apply such a discount in this instance and what the appropriate discount would be for the purposes of a rule based on the regulatory framework.  OSHA welcomes any feedback the SERs may have on how the costs of treating occupationally acquired infectious diseases are currently being borne and how that might change as a result of a rule based on the regulatory framework.
While the Agency usually uses a generalized estimate for medical removal protection, after examining the range of the most common infectious diseases and the infectious diseases specifically addressed by public health officials, OSHA has determined that the range of treatment requirements and medical removal recommendations are too varied for a generalized estimate to be reasonable.  For this SER Background Document, OSHA will be examining the potential costs for medical evaluation, follow-up, post exposure prophylaxis and medical removal protection for three diseases: influenza, tuberculosis, and MRSA.  The Agency believes that these diseases are representative of the types of infectious diseases that will be included in a full analysis.  They were chosen to show how OSHA would undertake this analysis for what OSHA preliminarily considers a low-cost but common disease (influenza), a high-cost but low incidence disease (tuberculosis), and a disease with multiple possible manifestations from relatively low cost to very high cost (MRSA).  If the Agency proceeds with proposing a rule based on the regulatory framework, OSHA anticipates expanding this analysis to account for potential costs related to medical evaluation, follow-up, post exposure prophylaxis and medical removal protection for additional diseases, including measles, mumps, rubella, pertussis, varicella, meningococcal disease, typhoid, SARS, norovirus, VRE, adenovirus, and Group A Streptococcus (GAS).  These agents  -  those being evaluated for this SER Background Document and those that would be evaluated for a proposal  -  are diseases covered by the CDC's guidelines for post-exposure treatment for healthcare workers (CDC, 2011d), plus those that the Agency has preliminarily concluded represent the most common infectious agents to which workers within the potential scope of a rule based on the regulatory framework are exposed.  It is currently OSHA's intent to cover post-exposure treatment and medical removal for most occupationally acquired infectious diseases amongst the covered worker population. For the three diseases OSHA looked at for this SER Background Document, the treatment, treatment costs, and days of medical restriction for exposed workers  -  both those with a suspected case of the disease and those with a confirmed case of the disease  -  are presented below in Tables VI-7 and VI-8.
Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily concludes that hospitals and laboratories are already highly compliant with a potential requirement to provide post exposure prophylactic treatments, as recommended by the CDC/HICPAC guidelines.  OSHA estimates that hospitals provide post exposure prophylactic treatment 91 percent of the time, while laboratories provide post exposure prophylactic treatment 86 percent of the time.  Three settings are estimated to be providing post exposure prophylactic treatment more than 60 percent of the time: other ambulatory care settings (62 percent), home healthcare agencies (66 percent), and nursing homes and long-term care facilities (68 percent).  Employers in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, are estimated to provide post exposure prophylactic treatment just 32 percent of the time.
OSHA also preliminarily concludes that hospitals and laboratories are already highly compliant with a potential requirement to provide post exposure testing for workers exposed to suspected or confirmed sources of infectious diseases.  OSHA estimates that employers in those settings provide such testing 88 and 86 percent of the time, respectively.  Employers in other ambulatory care settings, home healthcare agencies, and nursing homes and long-term care facilities provide such post exposure testing an estimated 55 to 70 percent of the time, while employers in "other occupational settings" provide such post exposure testing just an estimated 34 percent of the time.
OSHA also preliminarily estimates baseline compliance rates with respect to:  (1) the percentage of the time that employers restrict workers' normal duties and/or assign them alternative job duties when they have a known or suspected infectious disease; (2) the percentage of employers that direct workers not to come to work when they have a known or suspected infectious disease; and (3) the percentage of the time that employers provide normal pay and benefits during periods in which workers with a known or suspected infectious disease are directed not to come to work.  OSHA preliminarily estimates that 77 percent of the time, hospitals already restrict or alter workers' duties when they have a known or suspected infectious disease, and that 59 percent of hospitals direct those workers not to come to work.  With respect to long term care and nursing home facilities and laboratories, OSHA estimates that 60 and 66 percent of the time, respectively, employers in those settings restrict the duties of workers who have a known or suspected infectious disease and that, for each of those settings, just under 50 percent of employers direct affected workers not to come to work.  The Agency estimates that between 40 and 50 percent of the time, physicians' offices, dentists' offices and employers in other ambulatory care settings restrict the duties of affected workers, and that about 30 to 35 percent of employers in those settings direct affected workers not to come to work.  Employers in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, have the lowest estimated baseline compliance rates.  Employers in those settings are estimated to restrict the duties of affected workers 23 percent of the time.  And an estimated 27 percent of employers in those settings direct affected workers to not report to work.
While the percentage of employers estimated to be currently directing workers with a suspected or confirmed infectious disease to not report to work is relatively low for most settings (between 25 and 50 percent of employers in all settings except hospitals (59 percent)), the percentage of the time that employers are estimated to provide pay in the event workers are told not to report to work is relatively high.  In all settings except two (home healthcare (45 percent) and "other occupational settings" (41 percent)), OSHA estimates  that employers pay affected workers at least 60 percent of the time, with hospitals estimated to be providing pay most frequently (84 percent of the time).  OSHA is interested in any feedback or additional information that the SERs could supply on these preliminary estimates of the levels of current compliance with these draft provisions.
The remainder of the discussion on medical evaluation, follow-up, and medical removal protection outlines the potential costs of post exposure prophylaxis, related testing and treatment, and the estimated number of days a worker would need to be excluded from the workplace based on current guidelines and the potential requirements of a rule as outlined in the regulatory framework.  This information is also contained in Tables VI-7 and VI-8, at the end of the discussion.
Influenza
OSHA assumes, based on recommendations from the CDC (CDC, 2011d), that, as part of exposure incident-related post-exposure prophylaxis, a worker exposed to influenza should be offered a vaccine  -  estimated to cost $13.13 - if they have not already received the vaccine (CDC, 2013d).  The same CDC source recommends that an exposed worker needs the following post-exposure prophylactic treatment:  either Oseltamivir 75 mg once a day for 10 days, or Zanamivir 10 mg (inhalation) once a day for 10 days.   CDC guidance states that widespread or routine use of antiviral medications for chemoprophylaxis is not recommended but instead suggests close monitoring of exposed individuals with early initiation of antiviral treatment (CDC, 2011d).  OSHA has not made any determination as to the percentage of workers exposed to influenza who may be offered post-exposure prophylactic treatment, but the Agency preliminarily calculates, based on the average of the total cost for Oseltamivir and Zanamivir, that the average post-exposure preventative chemoprophylaxis for influenza is $69.03 per exposed, vaccinated worker (including the average cost of medication only) and $82.16 per exposed, unvaccinated worker (including both the cost of vaccination and the average cost of medication) (VA, 2013; PDR, 2013).
If a worker becomes ill with a case of influenza, CDC recommends the following treatment:  either Oseltamivir twice a day for 5 days; or Zanamivir twice a day for 5 days.  OSHA preliminarily estimates that treatment would cost, on average, $69.03, based on the average of the total cost for Oseltamivir and Zanamivir.  In addition, some workers may be given a rapid influenza diagnostic test, which OSHA estimates will cost $105.  OSHA has made no determination about the number of workers with influenza who may receive diagnostic testing, but welcomes comments from the SERs on this issue.  In sum, OSHA estimates a treatment cost of $69.03 per worker who is offered antiviral medication only, and $174.03 per worker who is offered both diagnostic testing and antiviral medication (CDC, 2011d; VA, 2013; PDR, 2013; AHRQ, 2011a).  And OSHA estimates that any employer whose workers would need to travel to an off-site location to receive tests would incur costs equal to 30 minutes of the worker's time for the time spent in transit plus $5.00 in travel costs.
With respect to influenza, a rule based on the regulatory framework would require medical removal protection benefits for one type of worker only:  a research or production laboratory worker removed from the job or otherwise medically limited as a result of an occupational exposure incident to an infectious agent (influenza) with which he or she is working.  It is easier to identify that influenza has been occupationally acquired in laboratories where specific infectious agents are being handled on a daily basis, than it is in other settings.  Current guidelines recommend that a worker with an active case of influenza be excluded from work until at least 24 hours after they no longer have a fever (without the use of fever-reducing medicines such as acetaminophen).  Further, workers in certain settings may be temporarily reassigned or excluded from work for 7 days from symptom onset or until the resolution of all non-cough symptoms, whichever is longer (CDC, 2011d, CDC, 2013e).
Tuberculosis
OSHA addresses the potential costs of routine screening for TB in the previous section on medical screening and surveillance.  A worker with a positive TB skin test or IGRA may be referred to a PLHCP for a chest x-ray and a determination regarding whether the worker has latent or active TB.  OSHA preliminarily estimates that a chest x-ray will cost $44 and take approximately thirty minutes of worker time for the x-ray plus an additional thirty minutes to review the results with a PLHCP.  The exam is estimated to cost $138 (FAIR Health, 2013; AMA, 2008).  If a worker must travel to a doctor's office or hospital to receive a chest x-ray, OSHA preliminarily estimates that the employer would incur costs equal to 30 minutes of travel time for that worker plus $5.00 in travel costs.
Cases of latent TB are treated with a six-to-nine month course of isoniazid, either daily or two times a week.  OSHA preliminarily estimates that isoniazid costs $0.05 per dose, resulting in a cost of $2.70 for 52 doses (a six month, twice a week course of treatment), $9.36 for 180 doses (a six month, daily dose course of treatment), $3.95 for 76 doses (a nine month, twice a week course of treatment), and $14.04 for 270 doses (a nine month daily course of treatment).  Cases of latent TB can also be treated with a four-month course of rifampin once a day, which, OSHA preliminarily estimates, costs $1.82 per dose, or $218.82 for 120 doses (CDC, 2013f, VA, 2013).  OSHA has not, at this time, made any determination as to the percentage of workers treated for latent TB who are treated with rifampin versus isoniazid, but the Agency welcomes comments from the SERs on the issue.
In addition to medication, workers treated for latent TB need to be seen by a doctor monthly to be administered a liver injury test.  OSHA preliminarily estimates that each office visit costs $138 and each hepatic function panel costs $46.12, for a total cost for doctor's visits and liver tests of $1,104.72 for a six month course of treatment, or $1,657.08 for a nine month course of treatment (AHRQ, 2011a).
OSHA preliminarily estimates that workers suspected of having an active case of TB, but who are eventually diagnosed with something other than TB, require a stay in a hospital isolation room for an average of 4 days.  The total cost of this hospitalization, and any related tests and treatments, is preliminarily estimated to be $12,578 (AHRQ, 2011a).  A worker who is confirmed to have an active case of TB will require, on average, an 8.3 day stay in a hospital isolation room, and the total cost of this hospitalization, and any related tests and treatments, is preliminarily estimated to be $42,327 (AHRQ, 2011a).
Treatment for an active case of TB would depend on the extent of disease and microbial antibiotic sensitivity, but it usually involves 6-9 months of a four drug regimen.  The initial treatment phase from the CDC recommended treatment is eight weeks of daily doses (56 doses total) of four different medications: isoniazid, rifampin, ethambutol, and pyrazinamide, followed by 18 weeks of daily doses (126 doses) of isoniazid and rifampin, or 18 weeks of twice weekly doses (36 doses) of isoniazid and rifampin.  OSHA preliminarily estimates that isoniazid costs $0.05 per dose, rifampin costs $1.82 per dose, ethambutol costs $1.77 per dose, and pyrazinamide costs $1.29 per dose.  This results in a total cost for the initial phase of treatment of $276.29.  For the daily dose option, the continuation phase of treatment is preliminarily estimated to cost $236.10.  For the twice-weekly dose option, the continuation phase of treatment is preliminarily estimated to cost $67.46 (CDC, 2013g, OSHA, 1997, VA, 2013).  In addition to treatment, a worker with an active case of TB that a PLHCP has determined was workplace acquired would need to be excluded from the workplace for three to four weeks (CDC, 2012b).

MRSA
Presently, no prophylactic treatment is recommended after an exposure to an active MRSA infection.  An active MRSA infection may result in a skin or soft tissue infection, which can be treated with topical antibiotic ointments, or  may result in a skin abscess, which must be incised and drained and requires clinic or emergency department visits.  Some skin infections become severe and will need oral antibiotics (Liu et al. 2011).
OSHA preliminarily estimates that an average active case of a MRSA-related skin or soft tissue infection will be diagnosed with a wound culture screening only, which is preliminarily estimated to cost $48.88.  If that culture is positive for MRSA, the worker will likely receive a second wound culture screening, this time with a colony count estimation (preliminarily estimated to cost an additional $32.01), and if that second culture is positive, the worker will likely receive a third wound culture screening, this time with molecular typing, either by nucleic acid probe (preliminarily estimated to cost an additional $100.80), or by pulsed-field gel electrophoresis (preliminarily estimated to cost an additional $46.20) (FAIR Health, 2013).  Any employer whose workers would need to travel to an off-site location to receive these diagnostic tests would incur costs equal to 30 minutes of that worker's time for the time spent in transit plus $5.00 in travel costs.  OSHA has not yet made a determination as to how many workers displaying a skin or soft tissue infection would be offered each type of diagnostic test and believes that some workers would be offered treatment without undergoing some or all of the testing described above.  OSHA welcomes feedback from the SERs on this issue.
OSHA preliminarily estimates that, for less serious cases, which do not require hospitalization, some workers positively diagnosed with MRSA-related skin and soft tissue infection may, depending on the location of the infection and the worker's job duties, require one week of medical restriction and treatment with a course of a topical antibiotic (Liu et al. 2011).  The topical treatment is preliminarily estimated to cost $0.94 per dose, and necessitate 10 doses, for a total cost of $9.43 (VA, 2013; PDR, 2013; Liu et al., 2011).  In some cases, a worker with a MRSA-related skin or soft tissue infection will receive a course of oral antibiotics, either Bactrim or Clindamycin, in addition to topical treatment.  OSHA preliminarily estimates that a course of Bactrim costs $33.60 (28 doses at $1.20 per dose) and a course of Clindamycin costs $47.04 (42 doses at $1.12 per dose) (PDR, 2013; VA, 2013)   If the infection results in an abscess, OSHA preliminarily concludes that the worker will need the abscess incised and drained.  This procedure can be done in a doctor's office or in an emergency department.  The abscess will either be drained through needle aspiration or through manual aspiration.  OSHA preliminarily estimates that the procedure costs between $329 and $650, depending on how complicated the procedure is (AHRQ, 2011a).  OSHA also preliminarily estimates that the procedure takes between 60 and 90 minutes of an employee's time, plus an additional 30 minutes and $5.00 in travel costs if the worker needs to travel to an off-site location.
In rare cases, MRSA may cause serious infections, such as complicated soft tissue infections, endocarditis, pneumonia, meningitis and bone (osteomyelitis) or joint infections.  These infections may require hospitalization, which may include surgical intervention, intensive medical therapy, and extended recovery time.
At this time, OSHA has not made any determination as to how many workplace-acquired MRSA infections there are in a given year, or any determination as to the percentage of those infections that are of the very serious type that are expensive to treat and require hospitalization.  The Agency welcomes any information the SERs can provide on the issue.
OSHA has, however, made preliminary estimates of the time and costs associated with hospitalizations for serious MRSA infections and various complications that can result from serious MRSA infections.  OSHA preliminarily estimates:  (1) that a serious MRSA-related skin and soft tissue infection requiring hospitalization results in nine days in the hospital, and costs $64,447; (2) that MRSA-related pneumonia requires eight days in the hospital, and costs $45,212; (3) that, depending on the location of the infection, MRSA-related osteomyelitis requires between five and eight days (average of just over six) in the hospital and costs between $25,262 and $53,791 (average of $39,067); (4) that MRSA-related endocarditis requires nine days in the hospital, and costs $62,051; and (5) that MRSA-related meningitis requires eight days in the hospital, and costs $50,258 (AHRQ, 2011a; CMS, 2013b).
A worker with a MRSA skin or soft tissue infection may require medical restriction, depending on the extent of the infection and the worker's job duties.  The Agency preliminarily concludes that workers will be non-infectious upon release from the hospital and would no longer be entitled to medical removal protection benefits under a rule as outlined in the regulatory framework.

   4.          Training

Per the regulatory framework, OSHA would require that employers institute a training program and ensure each worker who has occupational exposure during provision of direct patient care and/or performance of other covered tasks participates in the program.  OSHA would also require that training be provided initially, prior to the time of assignment to tasks where occupational exposure may take place, and that the initial training contain, at a minimum:
   * An accessible copy of a rule as outlined in the regulatory framework and an explanation of its contents;
   * A general explanation of the epidemiology and symptoms of common infectious diseases, including the signs and symptoms of infectious diseases that require further medical evaluation;
   * An explanation of the modes of transmission of infectious agents and applicable infection control procedures;
   * Information on vaccine(s) that will be made available to the worker;
   * An explanation of the employer's WICP and the means by which the worker can obtain a copy of the written plan;