The Bloodborne Pathogens Standard, and You
By Willam Duffy, RN, MJ, CNOR
This article discusses several key clarifications made to the Bloodborne Pathogens Standard, such as employee training, physician and temporary nursing personnel, the annual review of the bloodborne pathogen program, the use of safer medical devices, personal protective equipment, and administrative controls that are all addressed by OSHA in its revised directive and varying interpretation letters.
Author's Note: The information contained in this article is not intended to substitute for any provisions of the Occupational Safety and Health Act of 1970 or the requirements of the Occupational Exposure to Bloodborne Pathogens Standard.
In December 1991, the Occupational Safety and Health Administration (OSHA) issued the Occupational Exposure to Bloodborne Pathogens Standard. This standard was designed to protect nearly six million healthcare workers from the risk of exposure to pathogens such as the HIV and hepatitis B viruses.1 Since that time, employers have been scrambling to meet the requirements of the standard, so they may adequately protect their workers and avoid the fines associated with noncompliance.
Recently, OSHA surveyed healthcare institutions to assess the impact of the Bloodborne Pathogens Standard. The survey showed that progress has been made in reducing injuries and exposures to employees, but areas of concern and confusion still exist.2 One area of concern related to the broad scope of the Bloodborne Pathogens Standards leaves areas that are subject to interpretation by each healthcare institution and the OSHA compliance officers. OSHA has revised its Bloodborne Pathogens Compliance Directive to help institutions and their surveyors have a clearer understanding of the intent of the standards and further reduce the risks of bloodborne pathogens.2 Frequently, Infection Control Practitioners are key members in a hospital's efforts to institute safety measures and meet the intent of the standards.
The Scope of the Standard
Institutions continue to be confused on who is covered by the standard. Temporary workers and physicians are a major cause of the confusion, but the eligibility of other healthcare workers appears to be a problem also. In general, OSHA views any employee who has the reasonable potential for occupational exposure to bloodborne pathogens to be included within the scope of the standard. The standard states that occupational exposure is defined as "reasonably anticipated skin, eye, mucous membrane or parenteral contact with blood or [other potentially infectious material] OPIM.3
The standard does provide a list of jobs that may be associated with occupational exposure, but OSHA is clear that the list does not necessarily include or exclude any employee. The key to coverage is the employee's potential for occupational exposure.4
OSHA has notified its surveyors that part-time, temporary, and per diem healthcare workers are covered by the standard if their job duties present potential risks. Although, OSHA's jurisdiction does not appear to extend to students, the self-employed, or healthcare professionals who are sole practitioners. Additionally, any employee who is trained in first aid and has the responsibility to render aid as an expectation of their job is also within the scope of the standard.4
Employers must ensure that their employees who have the risk of occupational exposure participate in the training program that is provided during the employee's normal working hours. The program's structure must include training at the time of initial assignment and then at least annually thereafter. The standard specifies that the annual training must be provided within one year of the previous training date.4
Healthcare professionals have questioned the annual training requirement as being excessive in light of their high awareness of the risks associated with bloodborne pathogens. OSHA states it understands this level of knowledge and allows institutions to customize the annual training to focus on a "quick review" of previous training material and more importantly to inform employees regarding new healthcare worker issues and the policies implemented to address these issues.5
Additional training separate from the initial or annual training must be provided whenever there are changes in work tasks or procedures that may affect the potential for an occupational exposure.6 This training may be limited to addressing the new risks created by the changes, but employers should note that this is an interpretation point that OSHA has left to employers' control. Employers must assess each practice change for its potential to affect the employee and be prepared to demonstrate to OSHA why additional training was not required.
OSHA expects the training program to be adapted to varying levels of education, literacy, and language capabilities of the employees. This expectation requires employers to adjust their programs to ensure their employees can understand the materials presented. OSHA may question the efficacy of a training program designed for registered nurse professionals if it is used to train environmental personnel. Employers should be prepared to demonstrate their efforts to structure their training to meet their employee's needs. Some examples may include creating different programs for various groups, documenting the readability and educational grade level of the program, and the creation of multilingual programs.
Training programs should address how employees may access a copy of the standard, a general explanation of the symptoms and epidemiology of bloodborne diseases, modes of disease transmission, and the institution's exposure control plan and its accessibility. For example, the standard requires that while such viruses as HIV and HBV must be described employees also need to be educated regarding other bloodborne diseases like hepatitis C and syphilis.6 The training information on exposures must include methods to recognize activities that may lead to exposure, methods to limit exposures, the basis for selection of personal protective equipment, and information on hepatitis B vaccine and its availability. Additional information should address actions to take in notifying appropriate personnel regarding situations involving potentially infectious material, information on exposure reporting procedures, and post exposure follow-up and evaluation.7
The training program must also cover the types, use, location, removal, handling, decontamination, and disposal of personal protective equipment. An OSHA compliance officer will also look for explanations of the signs, labels, and color-coding used to identify hazardous or contaminated materials. Finally, the program must include an opportunity for interactive questions and answers with the trainer who must be knowledgeable of all material contained in the training programs.8
OSHA does allow the employer latitude to develop training programs to meet the institutions specific needs. The key is for the employer to be prepared to address how their training programs meet the requirements of the standard. Employers may write OSHA for clarification of questions regarding their training programs, and OSHA will respond with a detailed letter. Additionally, employers can access information contained in previous letters OSHA has answered by visiting OSHA's website at www.osha.gov.
Physicians and Agency Personnel
There seems to be debate in institutions across the country regarding potential liability resulting from physicians not following the Bloodborne Pathogens Standard. OSHA attempted to clarify its position on physicians in a 1993 interpretation letter.9 Generally, institutions can face fines due to the lack of compliance with the standards by physicians. The two significant areas of risk are practice patterns of physicians who are employees of the institution and unsafe practices by physicians who are independent practitioners.
The employee provisions of the Bloodborne Pathogens Standard covers physicians who are employees of an institution. Employing institutions must provide the physician with the same safety devices and workplace controls that they provide to traditional employees.9 Employers should also address having employee physicians attend the required training program. Physicians may resist the training, but it will be the employers who are liable for fines from OSHA if a physician is injured from exposure to a bloodborne pathogen.
Additionally, employers may be exposed to civil liability if they do not require employee physicians to attend training sessions or follow the institution's exposure plan. The potential exists for an injured physician to initiate legal action as a result of his or her injury and argue that the institution had a duty under the Bloodborne Pathogens Standard to protect him or her from these hazardous materials. Under this scenario, a surgeon, who is an employee of a hospital-owned medical group, theoretically can expose the hospital to potential fines and civil liabilities for violating the requirements of the Bloodborne Pathogens Standard if he or she does not wear appropriate eye protection during surgery, and the institution allows this behavior.
On the other hand, institutions are not responsible for enforcing the requirements covering employee protections for physicians who are independent practitioners. OSHA views these physicians as outside the employer-employee relationship. However, these physicians can still create problems for institutions. Hospitals are exposed to potential fines if an independent practitioner physician creates a hazardous environment for the hospital's employees.9 In these instances, OSHA expects the institution to intercede on behalf of their employees and correct the situation. Therefore, while a hospital does not have a duty to force an independent practitioner to follow the standard for him or herself, it does have a duty to force a physician to change practice patterns if his or her practice creates an unsafe environment.
Agency nurses also have an unusual standing under the Bloodborne Pathogen Standard. The responsibility for temporary workers was challenged in the case of the American Dental Association v. Martin.10 Under the theory of borrowed servants, the employing agency has a duty to perform initial and annual training of its employees in bloodborne pathogen protections. The hospital has the duty to provide them with the same safety devices and workplace controls that it would to its regular employees.11 In these situations, regular employees must be aware of the practice patterns of agency personnel and notify their supervisors of practices that do not satisfy the standard.
Work Place Practices
OSHA neither mandates specific work place controls nor states that employers must purchase expensive devices to prevent exposure. What the standard says is that employers must analyze the situation and take reasonable action to put into effect workplace controls that would limit the risk of exposure. OSHA has discovered that employers have achieved varying levels of success in instituting workplace controls. Most institutions responding to OSHA's request for information stated that they have instituted safer medical devices for IV line access (87%); however, use of safer medical devices in other areas was less extensive.12
Table 1 acknowledges that safer medical devices are being used in these applications, but it does not represent the extent of device utilization. OSHA has reported that many facilities have not adopted safer medical devices on a facility-wide scale.12
Other organizations have noted the varying levels of success in implementing work place controls. For example, in a recent survey of operating room leaders, more than half of the respondents reported that they have adopted strategies to reduce employee injuries and have vaccinated their at-risk staff against Hepatitis B, but many still have issues with employees and physicians wearing appropriate eye protection.13 Additionally, a study conducted by the Association of periOperative Registered Nurses (AORN) and the International Health Care Worker Safety Center at the University of Virginia documented multiple sources and types of injuries associated with exposure to blood or other potentially infectious material (OPIM).14
Control of the workplace would start with the exposure control plan. Each facility should have a written exposure control plan that identifies the tasks and procedures in which potential occupational exposure may occur and to identify the job positions whose duties encompass the performance of these tasks. OSHA compliance officers are instructed to review a facility's plan for its accessibility to employees and its ability to communicate the overall goals and references of the plan. Accessibility is a key component. Employers may adapt the location of a plan and even have the plan computerized as long as employees either have the training to access the plan in the computer or have access to the plan on their work shift.15
The officer will also look to see if the plan is updated annually or whenever necessary and that the plan contains information regarding the changes in technology that will reduce exposures. OSHA believes a periodic review of the plan will help protect employees by keeping them current with the latest information and knowledge regarding bloodborne pathogens. OSHA considers the lack of a control plan or an outdated plan a serious violation of the standard.
Facilities must institute a progressive action plan to implement their safety program. First, OSHA will monitor the facility for the practice of universal precautions. Alternative concepts such as Body Substance Isolation (BSI) and Standard Precautions define all body fluids and substances as infectious and are acceptable alternatives to universal precautions as long as the facility adheres to all other provisions of the standard.15 Next, the Compliance Officer will look for the engineering and work practice controls that the facility has put into place to reduce employee exposures. The use of needleless devices, shielded needles, plastic capillary tubes, no-hands handling contaminated sharps, and hands-free passing of surgical instruments are all examples of engineering or work practices that could reduce employee injuries. It is important that a facility include its employees in the selection of these safety devices. OSHA's research has shown that utilization of these devices is higher in institutions that have involved their employees in the decision-making process.16
Facilities must have this practice documented in their Exposure Control Plan to avoid a citation. OSHA has changed the language of the compliance instruction to state that the exposure control plan must be updated to reflect new technology to control occupational exposure. If engineering and work practice controls are not successful at eliminating the potential exposure, then personal protective equipment must be used. OSHA has instructed the Compliance Officer to interview employees and observe work practices in areas where occupational exposure occurs. The compliance officer will review the facility's records to find the areas that are more likely to be the site of exposures. OSHA has already identified that exposures occur most often in patient rooms, operating rooms, emergency departments, and the ICU areas. Nurses are the most likely healthcare workers to be injured, and the injury is most likely to be caused by a non-safety device. The compliance officer will then look to see if there is a pattern of repeating injuries and evaluate the institution's efforts to institute engineering or work practice controls.17
Progress has been made in reducing injuries to employees in the eight years since the Bloodborne Pathogen Standard have been issued, but areas of concern still remain. Safer medical devices are making headway in the medical market, but their use is still sparse in many areas. OSHA has decided to take the step of revising its compliance directive to encourage employers to use new medical devices to control exposures. The OSHA compliance directive can be beneficial to healthcare professionals charged with maintaining an institution's exposure control plan. The compliance directive will provide the healthcare worker into OSHA's insights regarding the assessment and enforcement of the standard. The document can be obtained from OSHA or accessed from their Web site at www.osha.gov.
Protecting workers from injuries is a key goal for any employer. However, now the employer has to meet certain expectations that are set by a third party who is in essence the judge and jury in determining compliance. It would seem reasonable that employers use every means available to understand and satisfy the expectations of the OSHA.
William J. Duffy, RN, MJ, CNOR, is the Director of Perioperative Services, at Evanston Northwestern Healthcare Corp. (Evanston, Ill).
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