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Disclaimer

The information contained is this document is not considered a substitute for any provisions of the Occupational Safety and Health Act of 1970 (OSH Act) or the requirements of 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens.

Federal/State OSHA Authority

Federal OSHA authority extends to all private sector employers with one or more employees, as well as federal civilian employees. In addition, many states administer their own occupational safety and health programs through plans approved under section 18(b) of the OSH Act. These plans must adopt standards and enforce requirements that are at least as effective as Federal OSHA requirements, including the Bloodborne Pathogens standard. Of the current 25 states and two territories with state plans, 22 cover both the private and public (state and local governments) sectors and five cover the public sector only. In the remaining jurisdictions where Federal OSHA has authority, hospitals operated by state, territorial or local governments are required to comply with the Bloodborne Pathogens standard with enforcement by the Centers for Medicare and Medicaid Services (42 U.S.C. 1395cc(a)(1)(V) and (b)(4)).

Copies of the OSHA Bloodborne Pathogens standard are available from the OSHA website.

Table of Contents
Introduction
Scope
Exposure Control
Methods of Control
    Universal Precautions
    Engineering Controls
    Work Practices
Personal Protective Equipment
Gloves
Housekeeping
Regulated Waste
Laundry
HIV and HBV Research Laboratories and Production Facilities
Hepatitis B Vaccination and Post-Exposure Follow-up Procedures
Communication of Hazards to Employees
Recordkeeping
Listing of Regional Offices

Introduction

On December 6, 1991, the Occupational Safety and Health Administration (OSHA) promulgated the Bloodborne Pathogens standard. This standard is designed to protect workers from the risk of exposure to bloodborne pathogens, such as the Human Immunodeficiency Virus (HIV) and the Hepatitis B Virus (HBV). The standard was revised by the Needlestick Safety and Prevention Act of 2000. This Act set forth in greater detail (and made more specific) OSHA's requirement for employers to identify, evaluate and implement safer medical devices. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in evaluating and choosing devices. These workers must be responsible for direct patient care and be potentially exposed to injuries from contaminated sharps.

The purpose of this document is to provide answers to some of the more commonly asked questions related to the Bloodborne Pathogens standard. It is not intended to be used as a substitute for the standard's requirements. Please refer to the standard for the complete text.

Scope

Q1. Who is covered by the standard?

A1. The standard applies to all employees who have occupational exposure to blood or other potentially infectious materials (OPIM).

• Occupational exposure is defined as reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.
• Blood is defined as human blood, human blood components, and products made from human blood.
• Other potentially infectious materials is defined as the following: saliva in dental procedures; semen; vaginal secretions; cerebrospinal, synovial, pleural, pericardial, peritoneal, and amniotic fluids; body fluids visibly contaminated with blood; along with all body fluids in situations where it is difficult or impossible to differentiate between body fluids; unfixed human tissues or organs (other than intact skin); HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture media or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

Q2. Does the Bloodborne Pathogens standard apply to employees in the agriculture, maritime and construction industries?

A2. The standard does not apply to agriculture or construction. The standard applies to ship repairing, shipbuilding and shipbreaking and on commercial fishing vessels and other vessels where OSHA has jurisdiction, but not in longshoring and marine terminals. However, the General Duty Clause (Section 5(a)(1) of the OSH Act) will be used, where appropriate, to protect employees from bloodborne hazards in construction, longshoring, marine terminals and agriculture.

Q3. Are volunteers and students covered by the standard?

A3. Volunteers are not covered by the standard. Students are covered if they are compensated.

Q4. Are physicians who are not employees of the hospital in which they work covered by the standard?

A4. Physicians employed by professional corporations are considered employees of that corporation. The corporation which employs these physicians may be cited by OSHA for violations affecting those physicians. The hospital where the physician practices may also be held responsible as the employer who created or controlled the hazard. Physicians who are sole practitioners or partners are not considered employees under the OSH Act; therefore, they are not covered by the protections of the standard. However, if a physician not employed by a hospital were to create a hazard to which hospital employees were exposed, it would be consistent with current OSHA policy to cite the hospital, the employer of the exposed employees, for failure to provide the protections of the Bloodborne Pathogens standard.

Q5. My company supplies contract employees to healthcare facilities. What are my responsibilities under the Bloodborne Pathogens standard?

A5. OSHA considers personnel providers, who send their own employees to work at other facilities, to be employers whose employees may be exposed to hazards. Because your company maintains a continuing relationship with its employees, but another employer (your client) creates and controls the hazard, there is a shared responsibility for assuring that your employees are protected from workplace hazards. The client employer has the primary responsibility for such protection, but the "lessor employer" likewise has a responsibility under the Occupational Safety and Health Act. In the context of OSHA's standard on Bloodborne Pathogens, 29 CFR 1910.1030, your company would be required, for example, to provide the general training outlined in the standard; ensure that employees are provided with the required vaccinations; and provide proper follow-up evaluations following an exposure incident. Your clients would be responsible, for example, for providing site-specific training and personal protective equipment, and would have the primary responsibility regarding the control of potential exposure conditions. The client, of course, may specify what qualifications are required for supplied personnel, including vaccination status. It is certainly in the interest of the lessor employer to ensure that all steps required under the standard have been taken by the client employer to ensure a safe and healthful workplace for the leased employees. Toward that end, your contracts with your clients should clearly describe the responsibilities of both parties in order to ensure that all requirements of the standard are met.

Q6. We have employees who are designated to render first aid. Are they covered by the standard?

A6. Yes. If employees are trained and designated as responsible for rendering first aid  as part of their job duties, they are covered by the protections of the standard. However, OSHA will consider it a de minimis violation - a technical violation carrying no penalties - if employees, who administer first aid as a collateral duty to their routine work assignments, are not offered the pre-exposure hepatitis B vaccination, provided that a number of conditions are met. In these circumstances, no citations will be issued.

The de minimis classification for failure to offer hepatitis B vaccination in advance of exposure does not apply to personnel who provide first aid at a first-aid station, clinic, or dispensary, or to the healthcare, emergency response or public safety personnel expected to render first aid in the course of their work. The de minimis classification is limited to persons who render first aid only as a collateral duty, responding solely to injuries resulting from workplace incidents, generally at the location where the incident occurred. To merit the de minimis classification, the following conditions also must be met:

• Reporting procedures must be in place under the exposure control plan to ensure that all first-aid incidents involving the presence of blood or OPIM are reported to the employer before the end of the work shift during which the incident occurs.
• Reports of first-aid incidents must include the names of all first-aid providers who rendered assistance and a description of the circumstances of the accident, including date and time, as well as a determination of whether an exposure incident, as defined in the standard, has occurred.
• A report that lists all such first-aid incidents must be readily available to all employees and provided to OSHA upon request.
• First-aid providers must receive training under the Bloodborne Pathogens standard that covers the specifics of the reporting procedures.
• All first-aid providers who render assistance in any situation involving the presence of blood or other potentially infectious materials, regardless of whether or not a specific exposure occurs, must have the vaccine made available to them as soon as possible but in no event later than 24 hours after the exposure incident. If an exposure incident as defined in the standard has taken place, other post-exposure follow-up procedures must be initiated immediately, as per the requirements of the standard.

Q7. Are employees such as housekeepers, maintenance workers and janitors covered by the standard?

A7. Housekeeping workers in healthcare facilities may have occupational exposure, as defined by the standard. Individuals who perform housekeeping duties, particularly in patient care and laboratory areas, may perform tasks, such as cleaning blood spills and handling regulated wastes, which cause occupational exposure.

While OSHA does not generally consider all maintenance personnel and janitorial staff employed in non-healthcare facilities to have occupational exposure, it is the employer's responsibility to determine which job classifications or specific tasks and procedures involve occupational exposure. For example, OSHA expects products such as discarded sanitary napkins to be discarded into waste containers which are lined in such a way as to prevent contact with the contents. At the same time, the employer must determine if employees can come into contact with blood during the normal handling of such products from initial pick-up through disposal in the outgoing trash. If OSHA determines, on a case-by-case basis, that sufficient evidence of reasonably anticipated exposure exists, the employer will be held responsible for providing the protections of 29 CFR 1910.1030 to the employees with occupational exposure.

Exposure Control

Q8. What is an exposure control plan?

A8. The exposure control plan is the employer's written program that outlines the protective measures an employer will take to eliminate or minimize employee exposure to blood and OPIM.

The exposure control plan must contain, at a minimum:

• The exposure determination which identifies job classifications with occupational exposure and tasks and procedures where there is occupational exposure and that are performed by employees in job classifications in which some employees have occupational exposure.
• The procedures for evaluating the circumstances surrounding exposure incidents;
• A schedule of how other provisions of the standard are implemented, including methods of compliance, HIV and HBV research laboratories and production facilities requirements, hepatitis B vaccination and post-exposure evaluation and follow-up, communication of hazards to employees, and recordkeeping;
  Methods of compliance include:
  • Universal Precautions;
  • Engineering and work practice controls, e.g., safer medical devices, sharps disposal containers, hand hygiene;
  • Personal protective equipment;
  • Housekeeping, including decontamination procedures and removal of regulated waste.
• Documentation of:
  • the annual consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure, and
  • the solicitation of non-managerial healthcare workers (who are responsible for direct patient care and are potentially exposed to injuries from contaminated sharps) in the identification, evaluation, and selection of effective engineering and work practice controls.

Q9. In the exposure control plan, are employers required to list specific tasks that place the employee at risk for all job classifications?

A9. No. If all the employees within a specific job classification perform duties where occupational exposure occurs, then a list of specific tasks and procedures is not required for that job classification. However, the job classification (e.g., "nurse") must be listed in the plan's exposure determination, and all employees within the job classification must be included under the requirements of the standard.

Q10. Can tasks and procedures be grouped for certain job classifications?

A10. Yes. Tasks and procedures that are closely related may be grouped. In other words, they must share a common activity, such as "vascular access procedure" or "handling of contaminated sharps."

Q11. Does the exposure control plan need to be a separate document?

A11. No. The exposure control plan may be part of another document, such as the facility's health and safety manual, as long as all components are included. However, in order for the plan to be accessible to employees, it must be a cohesive entity by itself or there must be a guiding document which states the overall policy and goals and references the elements of existing separate policies that comprise the plan. For small facilities, the plan's schedule and method of implementation of the standard may be an annotated copy of the final standard that states on the document how the provisions of the standard are implemented. Larger facilities could develop a broad facility program, incorporating provisions from the standard that apply to their establishments.

Q12. How often must the exposure control plan be reviewed?

A12. The standard requires an annual review of the exposure control plan. In addition, whenever changes in tasks, procedures, or employee positions affect, or create new occupational exposure, the existing plan must be reviewed and updated accordingly.

Q13. Must the exposure control plan be accessible to employees?

A13. Yes, the exposure control plan must be accessible to employees, as well as to OSHA and NIOSH representatives. The location of the plan may be adapted to the circumstances of a particular workplace, provided that employees can access a copy at the workplace during the workshift. If the plan is maintained solely on computer, employees must be trained to operate the computer.

A hard copy of the exposure control plan must be provided within 15 working days of the employee's request in accord with 29 CFR 1910.1020.

Q14. What should be included in the evaluation of an exposure incident?

A14. Following an exposure incident, employers are required to document, at a minimum, the route(s) of exposure, and the circumstances under which the exposure incident occurred. To be useful, the documentation must contain sufficient detail about the incident. There should be information about the following:

• The engineering controls in use at the time and work practices followed;
• Description of the device in use;  
• The protective equipment or clothing used at the time of the exposure incident;
• Location of the incident and procedures being performed when the incident occurred; and
• Employee’s training.
• The source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law.

The employer should then evaluate the policies and "failures of controls" at the time of the exposure incident to determine actions that could prevent future incidents.

Methods of Control

Universal Precautions

Q15. What is meant by the term Universal Precautions?

A15. Universal Precautions is OSHA's required method of control to protect employees from exposure to all human blood and OPIM. The term, "Universal Precautions," refers to a concept of bloodborne disease control which requires that all human blood and certain human body fluids be treated as if known to be infectious for HIV, HBV or other bloodborne pathogens.

Q16. Can Body Substance Isolation (BSI) be adopted in place of Universal Precautions?

A16. Yes. Body Substance Isolation is a control method that defines all body fluids and substances as infectious. BSI incorporates not only the fluids and materials covered by the standard but expands coverage to include all body substances. BSI is an acceptable alternative to Universal Precautions, provided facilities utilizing BSI adhere to all other provisions of the standard.

Engineering Controls

Q17. What are engineering controls?

A17. The term, "engineering controls," refers to controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.

Q18. What are some examples of safer devices or alternatives that could be used in lieu of exposed needles?

A18. Some examples of such devices or alternatives include needleless systems, needle-protected systems, and "self-sheathing" needles.

Q19. Are employers required to provide these safer devices?

A19. The standard requires that engineering and work practice controls be used to eliminate or minimize employee exposure. The Exposure Control Plan must document annual consideration and implementation of appropriate, commercially-available and effective engineering controls designed to eliminate or minimize exposure. The employer must solicit and document for this process input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps.

Q20. Is recapping of needles allowed?

A20. Bending, recapping, or removing contaminated needles is prohibited, except under certain circumstances. When the employer can demonstrate that bending, removal or recapping is required by a specific medical or dental procedure or that no alternative is feasible, such actions are permitted. However, such actions must be accomplished by some method other than the traditional two-handed procedure (e.g., a mechanical device or a one hand scoop method). For example, these actions may be necessary when performing blood gas analyses; when inoculating a blood culture bottle; or when administering incremental doses of a medication to the same patient. Where no alternative to bending, recapping, or removing contaminated needles is feasible or such action is required by a specific medical or dental procedure there must be a written justification to that effect included as part of the exposure control plan. On the basis of reliable evidence, this justification must state the reason for the employer's determination that no alternative is feasible or must specify that a particular medical or dental procedure requires, for example, the bending of the needle and the use of forceps to accomplish this task. Shearing or breaking contaminated needles is completely prohibited by the standard.

Q21. How should reusable sharps (e.g., large bore needles, scalpels, saws, etc.) be handled?

A21. Reusable sharps must be placed in containers which are puncture-resistant, leakproof on the sides and bottom, and properly labeled or color-coded until they are reprocessed. Contaminated reusable sharps must not be stored or reprocessed in a manner that would require the employee to reach by hand into containers.

Work Practices

Q22. Can employees of an ambulance medical rescue service eat or drink inside the cab of the unit?

A22. Employees are allowed to eat and drink in an ambulance cab only if the employer has implemented procedures to permit employees to wash up and change contaminated clothing before entering the ambulance cab, has prohibited the consumption, handling, storage, and transport of food and drink in the rear of the vehicle, and has procedures to ensure that patients and contaminated materials remain behind the separating partition.

Q23. What alternatives are acceptable if soap and running water are not available for handwashing?

A23. Antiseptic hand cleansers in conjunction with clean cloth/paper towels or antiseptic towelettes are examples of acceptable alternatives to running water. However, when these types of alternatives are used, employees must wash their hands with soap and running water as soon as feasible. These alternatives are only acceptable at worksites where it is  infeasible to provide soap and running water.

Q24. What are the labeling exemptions for specimens?

A24. The labeling exemption in section (d)(2)(xiii)(A) of the standard applies to facilities that handle all specimens with Universal Precautions provided the containers are recognizable as containing specimens. This exemption applies only while these specimens remain within the facility. Also, all employees who will have contact with the specimens must be trained to handle all specimens with Universal Precautions. If the specimens leave the facility (e.g., during transport, shipment, or disposal), a label or red color-coding is required.

Q25. Do specimens have to be double-bagged?

A25. Secondary containers or bags are only required if the primary container is contaminated on the outside. Also, if the specimen could puncture the primary container, a secondary puncture-resistant container is required. All specimen containers, primary and secondary, must be closed, properly labeled or color-coded (except as described above) and must prevent leakage.

Q26. Are employers required to decontaminate equipment before servicing or shipping?

A26. The standard requires that all equipment that may be contaminated must be examined and decontaminated as necessary before servicing or shipping. If complete decontamination is not feasible, the equipment must be labeled with the required biohazard label which also specifically identifies which portions of the equipment remain contaminated. In addition, the employer must ensure that this information is conveyed to the affected employees, the servicing representative, and/or the manufacturer, as appropriate, before handling, servicing, or shipping.

Personal Protective Equipment

Q27. What type of personal protective equipment (PPE) must employees in a dental office wear?

A27. The standard requires that PPE be "appropriate." PPE will be considered "appropriate" only if it does not permit blood or OPIM to pass through to, or reach, the skin, employees' underlying garments, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time that the PPE will be used. This allows the employer to select PPE based on the type of exposure and the quantity of blood or OPIM which can be reasonably anticipated to be encountered during performance of a task or procedure.

Q28. Who is responsible for providing PPE?

A28. The responsibility for providing, laundering, cleaning, repairing, replacing, and disposing of PPE at no cost to employees rests with the employer. Employers are not obligated under the standard to provide general work clothes to employees, but they are responsible for providing PPE. If laboratory jackets or uniforms are intended to protect the employee's body or clothing from contamination, they are to be provided at no cost by the employer.

Q29. Does protective clothing need to be removed before leaving the work area?

A29. Yes. OSHA requires that personal protective equipment be removed before leaving the work area. While "work area" must be determined on a case-by-case basis, a work area is generally considered to be an area where work involving occupational exposure occurs or where the contamination of surfaces may occur.

Q30. What type of eye protection do I need to wear when working with blood or OPIM?

A30. The use of eye protection would be based on the reasonable anticipation of facial exposure. Masks in combination with eye protection devices, such as glasses with solid side shields, goggles, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or OPIM may be generated and eye, nose, or mouth contamination can be reasonably anticipated.

Gloves

Q31. Are gloves required during phlebotomy procedures?

A31. Gloves must be worn by employees whenever any vascular access procedure is performed, including phlebotomy. Phlebotomy in volunteer blood donation centers is the only instance where some flexibility is permitted and even then certain requirements must be fulfilled. If an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer must (1) periodically reevaluate this policy; (2) make gloves available to all employees who wish to use them for phlebotomy; (3) not discourage the use of gloves for phlebotomy; and (4) require that gloves be used for phlebotomy when the employee has cuts, scratches, or other breaks in the skin; when the employee judges that hand contamination with blood may occur (e.g., performing phlebotomy on an uncooperative source individual); or when the employee is receiving training in phlebotomy.

Q32. When should gloves be changed?

A32. Disposable gloves shall be replaced as soon as practical after they have become contaminated, or as soon as feasible if they are torn, punctured, or their ability to function as a barrier is compromised. Hands must be washed after the removal of gloves used as PPE, whether or not the gloves are visibly contaminated.

Q33. Are gloves required when giving an injection?

A33. Gloves are not required to be worn when giving an injection as long as hand contact with blood or other potentially infectious materials is not reasonably anticipated.

Q34. What are some alternatives when an employee is allergic to the gloves provided?

A34. Hypoallergenic gloves, glove liners, powderless gloves or other similar alternatives must be provided for employees who are allergic to the gloves that are normally provided.

Housekeeping

Q35. What type of disinfectant can be used to decontaminate equipment or working surfaces which have come in contact with blood or OPIM?

A35. OSHA's position is that EPA-registered tuberculocidal disinfectants, diluted bleach solutions and EPA-registered disinfectants that are labeled as effective against both HIV and HBV as well as Sterilants/High-Level Disinfectants cleared by the FDA, meet the requirement in the standard and are "appropriate" disinfectants to clean contaminated surfaces, provided that such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended.

The particular disinfectant used, as well as the frequency with which it is used, will depend upon the circumstances in which a given housekeeping task occurs (i.e., location within the facility, type of surface to be cleaned, type of soil present, and tasks and procedures being performed). The employer's written schedule for cleaning and decontamination should identify such specifics on a task-by-task basis.

Regulated Waste

Q36. What does OSHA mean by the term "regulated waste"?

A36. The Bloodborne Pathogens standard uses the term, "regulated waste," to refer to the following categories of waste which require special handling: (1) liquid or semi-liquid blood or OPIM; (2) items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed; (3) items that are caked with dried blood or OPIM and are capable of releasing these materials during handling; (4) contaminated sharps; and (5) pathological and microbiological wastes containing blood or OPIM.

Q37. Are feminine hygiene products considered regulated waste?

A37. OSHA does not generally consider discarded feminine hygiene products, used to absorb menstrual flow, to fall within the definition of regulated waste. The intended function of products such as sanitary napkins is to absorb and contain blood. The absorbent material of which they are composed would, under most circumstances, prevent the release of liquid or semi-liquid blood or the flaking off of dried blood.

OSHA expects these products to be discarded into waste containers which are properly lined with plastic or wax paper bags. Such bags should protect the employees from physical contact with the contents.

At the same time, it is the employer's responsibility to determine the existence of regulated waste. This determination is not based on actual volume of blood, but rather on the potential to release blood (e.g., when compacted in a waste container). If OSHA determines, on a case-by-case basis, that sufficient evidence of regulated waste exists, either through observation (e.g., a pool of liquid in the bottom of a container, dried blood flaking off during handling), or based on employee interviews, citations may be issued if the employer does not comply with the provisions of the standard on regulated waste.

Q38. How should sharps containers be handled?

A38. Sharps containers shall be maintained upright throughout use, replaced routinely and not be allowed to overfill. When removing sharps containers from the area of use, the containers shall be:

• Closed immediately before removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping;
• Placed in a secondary container if leakage is possible. The second container shall be:
  • Closable;
  • Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and
  • Labeled or color-coded according to paragraph (g)(1)(i) of the standard.
• Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.

Upon closure, duct tape may be used to secure the lid of a sharps container as long as the tape does not serve as the lid itself.

Q39. Where should sharps containers be located?

A39. Sharps containers must be easily accessible to employees and located as close as feasible to the immediate area where sharps are used (e.g., patient care areas) or can be reasonably anticipated to be found (e.g., laundries).

In areas, such as correctional facilities and psychiatric units, there may be difficulty placing sharps containers in the immediate use area. Alternatives include using containers that are lockable or are designed to prevent removal of syringes while maintaining easy accessibility for discarding. If a mobile cart is used in these areas, an alternative would be to lock the sharps container onto the cart.

Q40. What type of container should be purchased to dispose of sharps?

A40. Sharps containers are made from a variety of products from cardboard to plastic. As long as they meet the definition of a sharps container (i.e., containers must be closable, puncture-resistant, leakproof on sides and bottom and labeled or color-coded), OSHA would consider them to be acceptable.

Q41. How do I dispose of regulated waste?

A41. Regulated waste shall be placed in containers which are:

• Closable;
• Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping;
• Labeled or color-coded in accordance with paragraph (g)(1)(i) of the standard; and
• Closed before removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.

If outside contamination of the regulated waste container occurs, it shall be placed in a second container. The second container shall be:

• Closable;
• Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping;
• Labeled or color-coded in accordance with paragraph (g)(1)(i) of the standard; and
• Closed before removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.

Disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories.

Q42. Do I need to autoclave waste before disposing?

A42. There is no specific requirement to autoclave waste before disposal. However, under the section on HIV and HBV Research Laboratories and Production Facilities, there is a requirement stating that all regulated waste from the facilities must be either incinerated or decontaminated by a method, such as autoclaving, known to effectively destroy bloodborne pathogens.

Laundry

Q43. What does OSHA mean by the term "contaminated laundry"?

A43. Contaminated laundry means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps.

Q44. How should contaminated laundry be handled?

A44. Contaminated laundry shall be handled as little as possible with a minimum of agitation. Contaminated laundry shall be bagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use. Other requirements include:

• Contaminated laundry shall be placed and transported in bags or containers labeled or color-coded in accordance with paragraph (g)(1)(i) of the standard. When a facility utilizes Universal Precautions in the handling of all soiled laundry, alternative labeling or color-coding is sufficient if it permits all employees to recognize the containers as requiring compliance with Universal Precautions.
• Whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior.
• The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment.
• When a facility ships contaminated laundry off-site to a second facility which does not utilize Universal Precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1)(i) of the standard.

Q45. Are employees allowed to take their protective equipment home and launder it?

A45. Employees are not permitted to take their protective equipment home and launder it. It is the responsibility of the employer to provide, launder, clean, repair, replace, and dispose of personal protective equipment.

Q46. Do employers have to buy a washer and dryer to clean employees' personal protective equipment?

A46. There is no OSHA requirement stipulating that employers must purchase a washer and dryer to launder protective clothing. It is an option that employers may consider. Another option is to contract out the laundering of protective clothing. Finally, employers may choose to use disposable personal protective clothing and equipment.

Q47. Are there guidelines to be followed when laundering personal protective equipment? What water temperature and detergent types are acceptable?

A47. The decontamination and laundering of protective clothing are governed by the laundry provisions of the standard in paragraph (d)(4)(iv). Washing and drying the garments should be done according to the clothing manufacturer's instructions.

HIV and HBV Research Laboratories and Production Facilities

Q48. Are academic HIV and HBV research laboratories included in the definition of a research laboratory under the standard?

A48. Academic HIV and HBV research laboratories are regarded as research laboratories under the standard. A research laboratory produces or uses research laboratory-scale amounts of HIV and HBV. Although research laboratories may not have the volume found in production facilities, they deal with solutions containing higher viral titers than those normally found in patients' blood.

Q49. Is animal blood used in research covered under the laboratory section of the standard?

A49. The standard covers animal blood only for those experimental animals purposely infected with HIV or HBV. Although the standard does not apply to animal blood unless it comes from an experimental animal infected with HIV or HBV, persons handling animals or animal blood should follow general precautions recommended by the Centers for Disease Control/National Institutes of Health Publication, Biosafety in Microbiological and Biomedical Laboratories.

Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up Procedures

Q50. Who must be offered the hepatitis B vaccination?

A50. The hepatitis B vaccination series must be made available to all employees who have occupational exposure, except as provided. The employer does not have to make the hepatitis B vaccination available to employees who have previously received the vaccination series, who are already immune as their antibody tests reveal, or for whom receiving the vaccine is contraindicated for medical reasons.

Q51. When must the hepatitis B vaccination be offered to employees?

A51. The hepatitis B vaccination must be made available within 10 working days of initial assignment, after appropriate training has been completed. Thus, arranging for the administration of the first dose of the series must be done at a time which will enable this schedule to be met . In addition, see Question 6 for vaccination of employees designated to render first aid.

Q52. Can pre-screening be required for hepatitis B titer? Post-screening?

A52. The employer cannot require an employee to take a pre-screening or post-vaccination serological test. An employer may, however, decide to make pre-screening available at no cost to the employee.

All medical evaluations and procedures, including the hepatitis B vaccine and vaccination series, are to be provided according to the current recommendations of the U.S. Public Health Service (USPHS). According to the current guidelines, employees who have ongoing contact with patients or blood and are at ongoing risk for percutaneous injuries should be tested for anti-HBs one to two months after the completion of the three-dose vaccination series. Non-responders must receive a second three-dose series and be retested after the second series. Non-responders must be medically evaluated. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm.

Q53. Can the employer make up its own declination form?

A53. If an employee declines the hepatitis B vaccination, the employer must ensure that the employee signs a hepatitis B vaccine declination. The declination's wording is found in Appendix A of the standard. A photocopy of the Appendix may be used as a declination form, or the words can be typed or written onto a separate document. An employer may use different words if they convey the same information. However, any additions to that language should be made for the sole purpose of improving employee comprehension. Forms must not add language that would discourage employee acceptance of the vaccine, add liability concerns or require the employee to provide confidential medical information.

Q54. Can employees refuse the vaccination?

A54. Employees have the right to refuse the hepatitis B vaccine and/or any post-exposure evaluation and follow-up. Note, however, that the employee needs to be properly informed of the benefits of the vaccination and post-exposure evaluation through training. The employee also has the right to decide to take the vaccination at a later date if he or she so chooses. The employer must make the vaccination available at that time.

Q55. Can the hepatitis B vaccination be made a condition of employment?

A55. OSHA does not have jurisdiction over this issue.

Q56. Is a routine booster dose of hepatitis B vaccine required?

A56. The U.S. Public Health Service (USPHS) does not recommend routine booster doses of hepatitis B vaccine, so they are not required at this time. However, if a routine booster dose of hepatitis B vaccine is recommended by the USPHS at a future date, such booster doses must be made available at no cost to those eligible employees with occupational exposure.

Q57. Whose responsibility is it to pay for the hepatitis B vaccine?

A57. The responsibility lies with the employer to make the hepatitis B vaccine and vaccination, including post-exposure evaluation and follow-up, available at no cost to the employees.

Q58. What information must the employer provide to the healthcare professional following an exposure incident?

A58. The healthcare professional must be provided with a copy of the standard as well as the following information:

• A description of the employee's duties as they relate to the exposure incident;
• Documentation of the route(s) and circumstances of the exposure;
• The results of the source individual's blood testing, if available; and
• All medical records relevant to the appropriate treatment of the employee, including vaccination status, which are the employer's responsibility to maintain.

Q59. What serological testing must be done on the source individual?

A59. The employer must identify and document the source individual, if known, unless the employer can establish that identification is not feasible or is prohibited by state or local law. The source individual's blood must be tested as soon as feasible, after consent is obtained, in order to determine HIV and HBV infectivity. The information on the source individual's HIV and HBV testing must be provided to the evaluating healthcare professional. Also, the results of the testing must be provided to the exposed employee. The exposed employee must be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual.

Q60. What if consent cannot be obtained from the source individual?

A60. If consent cannot be obtained and is required by state law, the employer must document in writing that consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and the results documented.

Q61. When is the exposed employee's blood tested?

A61. After consent is obtained, the exposed employee's blood is collected and tested as soon as feasible for HIV and HBV serological status. If the employee consents to the follow-up evaluation after an exposure incident, but does not give consent for HIV serological testing, the blood sample must be preserved for 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested for HIV, testing must be done as soon as feasible.

Q62. What information does the healthcare professional provide to the employer following an exposure incident?

A62. The employer must obtain and provide to the employee a copy of the evaluating healthcare professional's written opinion within 15 days of completion of the evaluation. The healthcare professional's written opinion for hepatitis B is limited to whether hepatitis B vaccination is indicated and if the employee received the vaccination. The written opinion for post-exposure evaluation must include information that the employee has been informed of the results of the evaluation and told about any medical conditions resulting from exposure that may require further evaluation and treatment. All other findings or diagnoses must be kept confidential and not included in the written report.

Q63. What type of counseling is required following exposure incidents?

A63. The standard requires that post-exposure counseling be given to employees following an exposure incident. Counseling concerning infection status, including results and interpretation of all tests, will assist the employee in understanding the potential risk of infection and in making decisions regarding the protection of personal contacts. For example, counseling should include USPHS recommendations about the transmission and prevention of HIV. These recommendations include refraining from blood, semen, or organ donation; abstaining from sexual intercourse or using measures to prevent HIV transmission during sexual intercourse; and refraining from breast feeding infants during the follow-up period. Counseling based on the USPHS recommendations must also be provided for HBV and HCV and other bloodborne pathogens, as appropriate. In addition, counseling must be made available regardless of the employee's decision to accept serological testing.

Q64. What recordkeeping does OSHA require for exposure incidents?

A64. Any employer who is required to maintain a log of occupational injuries and illnesses under OSHA’s Recordkeeping regulation (29 CFR Part 1904) is also required to establish and maintain a sharps injury log for the recording of percutaneous injuries from contaminated sharps. Employers must also record all work-related needlestick injuries and cuts from sharp objects that are contaminated with another person's blood or other potentially infectious material (as defined by 29 CFR 1910.1030) on the OSHA 300 Log.  Employers may use the OSHA 300 Log to meet the requirements of the sharps injury log provided they enter the same information required for the sharps injury log on the OSHA 300 Log and maintain the records in a way that segregates sharps injuries from other types of work-related injuries and illnesses, or allows sharps injuries to be easily separated. Employers must enter sharps injury cases on the OSHA 300 Log and the sharps injury log without entering the employee’s name. [See the requirements for privacy cases in paragraphs 1904.29(b)(6) through 1904.29(b)(10)].

If an employee is splashed or exposed to blood or OPIM without being cut or punctured, the incident must be recorded on the OSHA 300 Log if it results in the diagnosis of a bloodborne illness or if it meets one or more of the recording criteria in 29 CFR 1904.7.

If an employer is exempted from the OSHA recordkeeping rule, the employer does not have to maintain a sharps log.

Communication of Hazards to Employees

Q65. When are labels required?

A65. A warning label that includes the universal biohazard symbol (see 29 CFR 1910.1030(g)(1)(i)(B) followed by the term "biohazard," must be included on bags/containers of contaminated laundry; on bags/containers of regulated waste; on refrigerators and freezers that are used to store blood or OPIM; and on bags/containers used to store, dispose of, transport, or ship blood or OPIM (e.g., specimen containers). In addition, contaminated equipment which is to be serviced or shipped must have a readily observable label attached which contains the biohazard symbol and the word "biohazard" along with a statement relating which portions of the equipment remain contaminated.

Q66. What are the required colors for the labels?

A66. The labels must be fluorescent orange or orange-red or predominantly so, with symbols and lettering in a contrasting color. The label must be either an integral part of the container or affixed as close as feasible to the container by a string, wire, adhesive, or other method to prevent its loss or unintentional removal.

Q67. Can there be substitutes for the labels?

A67. Yes. Red bags or red containers may be substituted for the biohazard labels.

Q68. What are the exceptions to the labeling requirement?

A68. Labeling is not required for:

• Containers of blood, blood components, and blood products bearing an FDA-required label that have been released for transfusion or other clinical uses;
• Individual containers of blood or OPIM that are placed in secondary labeled containers during storage, transport, shipment, or disposal;
• Specimen containers, if the facility uses Universal Precautions when handling all specimens, the containers are recognizable as containing specimens, and the containers remain within the facility;
• Laundry bags or containers containing contaminated laundry may be marked with an alternative label or color-coded provided the facility uses Universal Precautions for handling all soiled laundry, and the alternative marking permits all employees to recognize the containers as requiring compliance with Universal Precautions. If contaminated laundry is sent off-site for cleaning to a facility which does not use Universal Precautions in the handling of all soiled laundry, it must be placed in a bag or container which is red in color or labeled with the biohazard label described above; and
• Regulated waste that has been decontaminated.

Q69. Does OSHA accept Department of Transportation's (DOT) labels for waste and specimens which will be shipped or transported?

A69. The labeling requirements do not preempt either the U.S. Postal Service labeling requirements (39 CFR Part III) or the Department of Transportation's Hazardous Materials Regulations (49 CFR Parts 171-181).

DOT labeling is required on some transport containers (i.e., those containing "known infectious substances"). It is not required on all containers for which 29 CFR 1910.1030 requires the biohazard label. Where there is an overlap between the OSHA-mandated label and the DOT-required label, the DOT label will be considered acceptable on the outside of the transport container provided that the OSHA-mandated label appears on any internal containers which may be present. Containers serving as collection receptacles within a facility must bear the OSHA label since these are not covered by the DOT requirements.

Q70. Which employees must be trained?

A70. All employees with occupational exposure must receive initial and annual training. In addition, training must be provided when changes (e.g., modified/new tasks or procedures) affect a worker’s occupational exposure.

Q71. Must part-time and temporary employees be trained?

A71. Part-time and temporary employees are covered and are also to be trained on company time.

Q72. Who has the responsibility for training workers employed by agencies which provide personnel (e.g., nurses) to other employers?

A72. As stated in a similar answer to Question 5, OSHA considers personnel providers, who send their own employees to work at other facilities, to be employers whose employees may be exposed to hazards. Because personnel providers maintain a continuing relationship with their employees, but another employer (your client) creates and controls the hazard, there is a shared responsibility for assuring that your employees are protected from workplace hazards. The client employer has the primary responsibility for such protection, but the "lessor employer" likewise has a responsibility under the Occupational Safety and Health Act.

In the context of OSHA's standard on Bloodborne Pathogens, the personnel provider would be required to provide the general training outlined in the standard and the client employer would be responsible for providing site-specific training.

The contract between the personnel provider and the client should clearly describe the training responsibilities of both parties in order to ensure that all training requirements of the standard are met.

Q73. What are the qualifications that a person must possess in order to conduct employee training regarding bloodborne pathogens?

A73. The person conducting the training is required to be knowledgeable in the subject matter covered by the elements in the training program and be familiar with how the course topics apply to the workplace that the training will address. The trainer must demonstrate expertise in the area of occupational hazards of bloodborne pathogens.

Q74. Where can I obtain information for conducting training on the Bloodborne Pathogens standard?

A74. OSHA's Directorate of Training and Education maintains an online library of training materials. OSHA’s Bloodborne Pathogens and Needlestick Prevention Topics Page provides resources that can be used for training. Other sources of information include local, area and regional OSHA offices. In addition, each regional office has a Bloodborne Pathogens Coordinator who answers compliance and related questions on the standard.

All information available through OSHA should be used as a supplement to the employer's training program. The Bloodborne Pathogens standard lists the elements required in a training program. [29 CFR 1910.1030(g)(2)(vii)].

Q75. What are some examples of persons who could conduct training on the Bloodborne Pathogens standard?

A75. Examples of health care professionals include infection control practitioners, nurse practitioners, and registered nurses. Non-healthcare professionals include industrial hygienists, epidemiologists or professional trainers, provided that they can demonstrate evidence of specialized training in the area of bloodborne pathogens.

Recordkeeping

Q76. What is contained in the medical record?

A76. The medical record includes the name and social security number of the employee; a copy of the employee's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee's ability to receive the vaccination; copies of all results of examinations, medical testing and follow-up procedures; copies of the healthcare professional's written opinion; and copies of the information provided to the healthcare professional.

Q77. Who keeps the medical records?

A77. The employer is responsible for the establishment and maintenance of medical records. However, these records may be kept off-site at the location of the healthcare provider.  The employer must ensure that the medical records are kept confidential and are not reported or disclosed without the express written consent of the worker, except as required by the standard or as may be required by law.

Q78. How long must the medical records be kept?

A78. Medical records must be kept for the duration of employment plus 30 years.

Q79. What is included in the training record?

A79. The training record contains the dates of the training, the contents or a summary of the training sessions, the names and job titles of all persons attending the training, and the names and qualifications of the persons conducting the training.

Q80. How long must training records be kept?

A80. Training records must be retained for 3 years from the training date.

Region I
(CT^*, ME, MA, NH, RI, VT^*)
JFK Federal Building, Room E340
Boston, MA 02203
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^*These states and territories operate their own OSHA-approved job safety and health plans and cover state and local government employees as well as private sector employees. The Connecticut, Illinois, New Jersey, New York and Virgin Islands programs cover public employees only. (Private sector workers in these states are covered by Federal OSHA.) States with approved programs must have standards that are identical to, or at least as effective as, the Federal OSHA standards.

Note: To get contact information for OSHA area offices, OSHA-approved state plans and OSHA consultation projects please visit us online or call us at 1-800-321-OSHA (6742).

(Corrected 11/01/2011. Updated information to reflect current OSHA policy.)

 

 

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