Section 1910.1030 of the Code of Federal Regulations sets forth duties required of an employer in providing protection to his employees who are or may be exposed to bloodborne pathogens.
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OSHA Bloodborne Pathogens Standard
First among these duties is to determine, employee by employee and task by task, which employees performing which tasks will be exposed to bloodborne pathogens in the course of the work, which may be so exposed, and which will not be exposed.
Once this assessment is made, the employer must protect the employee to the extent possible without regard to the specific origin of the blood or other potentially infectious material. This is known as the principle of universal precautions.
To reduce exposure to bloodborne pathogens all human blood and body fluids shall be considered potentially infectious materials. Precautions must be uniformly used with all patients regardless of whether their blood or body fluids are infected.
Methods of Control: Engineering and Work Practice Controls
Engineering and work practice controls are the primary methods used to prevent occupational transmission of HBV and HIV. Personal protective clothing and equipment also are necessary when occupational exposure to bloodborne pathogens remains even after instituting these controls.
Engineering controls reduce employee exposure in the workplace by either removing or isolating the hazard or isolating the worker from exposure. Self-sheathing needles, puncture-resistant disposal containers for contaminated sharps instruments, resuscitation bags, and ventilation devices are examples of engineering controls.
Engineering controls must be examined and maintained or replaced on a scheduled basis.
Proper work practice controls alter the manner in which a task is performed. In work areas where a reasonable likelihood of occupational exposure exists, work practice controls include restricting eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses; prohibiting mouth pipetting; preventing the storage of food and/or drink in refrigerators or other locations where blood or other potentially infectious materials are kept; providing and requiring the use of handwashing facilities; and routinely checking equipment and decontaminating it prior to servicing and shipping. Other work practice requirements include, but are not limited to, the following:
* Washing hands when gloves are removed and as soon as possible after skin contact with blood or other potentially infectious materials occurs.
* Recapping, removing or bending needles is prohibited unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical procedure. When recapping, bending or removing contaminated needles is required by a medical procedure, this must be done by mechanical means, such as the use of forceps, or a one-handed technique.
* Shearing or breaking contaminated needles is not permitted.
Personal Protective Clothing and Equipment (PPCE)
Universal precautions, work practice controls, and engineering controls are the primary methods for ensuring infection control in health care facilities. However, these regulations can be further strengthened through the use of personal protective clothing and equipment (PPCE). Such equipment includes, but is not limited to, gloves, gowns, laboratory coats, face shields or masks, and eye protection. Personal protective equipment is considered appropriate only if it does not permit blood or other potentially infectious materials to pass through or reach employees' work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.
The OSHA standard requires that PPCE must be used to prevent blood or other potentially infectious materials (OPIM) from passing through to, or contacting the employees' work or street clothes, undergarments, skin, eyes, mouth, or other mucous membranes, unless engineering controls and work practices have eliminated occupational exposure.
(1) Employers must provide, make accessible, and require the use of personal protective equipment at no cost to the employee. Employers also must ensure that protective equipment is properly used, cleaned, laundered, repaired or replaced, as needed, or discarded. The type and amount of PPCE should be chosen to protect against contact with blood or OPIM based upon the type of exposure and quantity of these substances which can be reasonably anticipated to be encountered during the performance of a task or procedure.
(2) The standard requires that the employer provide PPCE in appropriate sizes and accessible locations. In addition, hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided.
* While many employees have traditionally provided and laundered their own uniforms or laboratory coats or the like, if the item's intended function is to act as PPCE, then it is the employer's responsibility to provide, clean, repair, replace, and/or dispose of it.
* Home laundering is not permitted since the employer cannot guarantee that proper handling or laundering procedures are being followed; it could also lead to the migration of contaminants to the home.
* If the employee wishes to choose, wear, and maintain his/her own uniform or laboratory coat, then he/she would need to don additional employer-handled and employer- controlled PPCE when performing tasks where it is reasonable to anticipate exposure to blood or OPIM.
* Scrubs are usually worn in a manner similar to street clothing, and normally should be covered by appropriate gowns, aprons or laboratory coats when splashes to skin or clothing are anticipated. If a pullover scrub (as opposed to scrubs with snap closures) becomes minimally contaminated, employees should be trained to remove the pullover scrub in such a way as to avoid contact with the outer surface; e.g., rolling up the garment as it is pulled toward the head for removal. However, if the amount of blood exposure is such that the blood penetrates the scrub and contaminates the inner surface, not only is it impossible to remove the scrub without exposure to blood, but the penetration itself would constitute exposure. It may be prudent to train employees to cut such a contaminated scrub to aid removal and prevent exposure to the face.
(3) Emergency ventilation devices (e.g., masks, mouthpieces, resuscitation bags, shields/overlay barriers) also fall under the scope of PPCE and hence must be provided by the employer for use in resuscitation by employees who can reasonably be expected to resuscitate a patient.
(4) The standard provides for a limited exemption from the use of PPCE, based on situations in which use of PPCE would prevent the proper delivery of health care or public safety services, or would pose an increased hazard to the personal safety of the worker. The following represents examples of when such a situation could occur:
* A sudden change in patient status occurs such as when an apparently stable patient unexpectedly begins to hemorrhage profusely, putting the patient's life in immediate jeopardy;
* A firefighter rescues an individual who is not breathing from a burning building and discovers that his/her resuscitation equipment is lost/damaged and he/she must administer CPR;
* A bleeding suspect unexpectedly attacks a police officer with a knife, threatening the safety of the officer and/or coworkers.
Note: An employee's decision not to use PPCE is to be made on a case-by-case basis and must have been prompted by legitimate and truly extenuating circumstances. This does not relieve the employer of the responsibility to ensure that PPCE is readily accessible at all times. The employer shall document why PPCE was not used in each case and evaluate the circumstances surrounding the incident to reduce the likelihood of a future (unprotected) incident.
(5) If it is common practice that PPCE is not utilized during certain situations or procedures where exposure to blood or OPIM is anticipated, then a violation of the standard would exist.
(6) To minimize migration of contamination beyond the work area, employees who are provided designated lunchrooms or break rooms are permitted to eat/drink/smoke in these areas as long a the employees wash up and change any contaminated clothing prior to entry.
NOTE: There are no currently available standardized methods of testing and classification of performance specifications for resistance of clothing to biological hazards i.e. there are no "OSHA-approved" PPCE.
Under the standard, each place of employment must be kept clean and sanitary. To do this, the employer must develop and implement a cleaning schedule that includes appropriate methods of decontamination and tasks or procedures to be performed. This written schedule must be based on the location within the facility, the type of surfaces to be cleaned, the type of contamination present, the tasks or procedures to be performed, and their location within the facility.
The employer also must ensure that the following housekeeping procedures are followed:
o Clean and decontaminate all equipment and environmental and work surfaces that have been contaminated with blood or other potentially infectious materials: immediately when overtly contaminated, after any spill of blood or other potentially infectious materials, and at the end of the work shift when surfaces have become contaminated since the last cleaning.
o Remove and replace protective coverings such as plastic wrap and aluminum foil when contaminated.
o Inspect and decontaminate, on a regular basis, reusable receptacles such as bins, pails, and cans that have a likelihood for becoming contaminated. When contamination is visible, clean and decontaminate receptacles immediately, or as soon as feasible.
o Always use mechanical means such as tongs, forceps, or a brush and a dust pan to pick up contaminated broken glassware; never pick up with hands even if gloves are worn.
o Place regulated waste in closable and labeled or color coded containers. When storing, handling, transporting or shipping, place other regulated waste in containers that are constructed to prevent leakage. Discard all regulated waste according to federal, state, and local regulations.
o Handle contaminated laundry as little as possible and with a minimum of agitation.
o Use appropriate personal protective equipment when handling contaminated laundry.
o Place wet contaminated laundry in leakproof, labeled or color-coded containers before transporting.
o Bag contaminated laundry at its location of use.
o Never sort or rinse contaminated laundry in areas of its use.
o When discarding contaminated sharps, place them in containers that are closable, puncture-resistant, appropriately labeled or color-coded, and leakproof on the sides and bottom.
If a commercial laundry is used which does not use universal precautions, all bags or containers of laundry for pickup must be appropriately labeled or color-coded.
Regulated waste requires special handling and must be placed in appropriate containers.
Regulated waste includes the following:
1. liquid or semi-liquid blood or other potentially infectious material
2. items contaminated with blood or other potentially infectious material that would release these substances in a liquid or semi-liquid state if compressed
3. items that are caked with blood or other potentially infectious material and are capable of releasing these materials during handling
4. contaminated sharps
5. pathologic and microbiological wastes containing blood or other potentially infectious material.
The containers into which regulated waste is stored, transported or shipped must be closable. The container must also be constructed so as to contain the waste and prevent leakage of its contents. If the waste could puncture the primary container, the primary container must be placed into a puncture resistant secondary container. If outside contamination of the primary container occurs, the primary container must also be placed within a second container which prevents leakage.
The standard requires that fluorescent orange or orange-red warning labels be attached to containers of regulated waste, to refrigerators and freezers containing blood and other potentially infectious materials, and to other containers used to store, transport, or ship blood or other potentially infectious materials (see Table 2). These labels are not required when
* red bags or red containers are used
* containers of blood, blood components, or blood products are labeled as to their contents and have been released for transfusion or other clinical use
* individual containers of blood or other potentially infectious materials are placed in a labeled container during storage, transport, shipment or disposal.
The warning label must be fluorescent orange or orange-red, contain the biohazard symbol and the word BIOHAZARD, in a contrasting color, and be attached to each object by string, wire, adhesive, or another method to prevent loss or unintentional removal of the label.
What to Do if an Exposure Incident Occurs
The standard requires that the post-exposure medical evaluation and followup be made available immediately for employees who have had an exposure incident. At a minimum, the evaluation and followup must include the following elements:
* Document the routes of exposure and how exposure occurred
* Identify and document the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law
* Obtain consent* and test source individual's blood as soon as possible to determine HIV and HBV infectivity and document the source's blood test results
* Provide the exposed employee with the source individual's test results and information about applicable disclosure laws and regulations concerning the source identity and infectious status
* After obtaining consent, collect exposed employee's blood as soon as feasible after the exposure incident and test blood for HBV and HIV serological status
* If the employee does not give consent for HIV serological testing during the collection of blood for baseline testing, preserve the baseline blood sample for at least 90 days**
* Provide HBV and HIV serological testing, counseling and safe and effective post-exposure prophylaxis following the current recommendations of the U.S. Public Health Service
* If consent is not obtained, the employer must show that legally required consent could not be obtained. Where consent is not required by law, the source individual's blood, if available, should be tested and the results documented.
** If during this time, the exposed employee elects to have the baseline sample tested, testing shall be done as soon as feasible.
The employer must give the health care professional responsible for the employee's hepatitis B vaccination and post-exposure evaluation and follow up a copy of the OSHA standard. The employer must also provide to the health care professional evaluating the employee after an exposure incident a description of the employee's duties relevant to the exposure incident, documentation of the route(s) of exposure, circumstances of exposure, and results of the source individual's blood tests, if available, and all relevant employee medical records, including vaccination status.
Within 15 days after evaluation of the exposed employee, the employer must provide the employee with a copy of the health care professional's written opinion. The written opinion is limited to whether the vaccine is indicated and if it has been received. The written opinion for post exposure evaluation must document that the employee has been informed of the results of the medical evaluation and of any medical conditions resulting from the exposure incident that may require further evaluation or treatment. All other diagnoses must remain confidential and not be included in the written report.
Employers must preserve and maintain for each employee an accurate record of occupational exposure according to OSHA's rule governing access to employee exposure and medical records, Title 29 Code of Federal Regulations, Part 1910.20.
Under the bloodborne pathogens standard, however, medical records also must include the following information:
* Employee's name and social security number;
* Employee's hepatitis B vaccination status including vaccination dates and any medical records related to the employee's ability to receive vaccinations;
* Results of examinations, medical testing, and post-exposure evaluation and followup procedures;
* Health care professional's written opinion; and
* A copy of the information provided to the health care professional
Training and Training Records
The bloodborne pathogens standard requires employers to maintain and to keep accurate training records for 3 years and to include the following:
* Training dates,
* Content or a summary of the training,
* Names and qualifications of trainer(s), and
* Names and job titles of trainees.