Recordkeeping

Q. What is contained in the medical record?

A. 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 the follow-up procedures; copies of the healthcare professional’s written opinion; and a copy of the information provided to the healthcare professional.

Q. Who keeps the medical records?

A. 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.

Q. How long must the medical records be kept?

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

Q. What information must be included on the sharps injury log?

A. The sharps injury log, which protects the confidentiality of the injured employee, must contain at a minimum, the type and brand of device involved in the incident; the department or work area where the exposure incident occurred; and an explanation of how the incident occurred.

Q. How long must the sharps injury log be retained?

A. The sharps injury log must be retained for five years following the end of the year to which it relates.

Q. What is included in the training record?

A. 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.

Q. How long must the training records be kept?

A. Training records must be retained for three years from the training date.

Communication of Hazard to Employees | Bloodborne Pathogens

Q. When are labels required?

A. A warning label that includes the universal biohazard symbol, 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.

Q. What are the required colors for the labels?

A. The background 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.

Q. Can there be substitutes for the labels?

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

Q. What are the exceptions to the labeling requirement?

A. 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 Univeral 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.

• Regulated waste that has been decontaminated.

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

A. 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 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.

Q. Which employees must be trained?

A. All employees with occupational exposure must receive initial and annual training.

Q. Should part-time and temporary employees be trained?

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

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

A. As stated in a similar answer, OSHA considers personnel providers, who send their own employees to work at other facilities, to be employers whose employees may be exposed to hazards. Since personnel providers maintain a continuing relationship with their employees, but another employer (your client) creates and controls the hazard, there is a shared responsibilty 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. 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.

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

A. 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.

Q. Who are some examples of persons who could conduct training on the bloodborne standard?

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

Hepatitis B Vaccination and Post-Exposure Follow-Up Procedures

Q. Who must be offered the hepatitis B vaccination?

A. The hepatitis B vaccination series must be made available to all employees who have occupational exposure. 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 who are prohibited from receiving the vaccine for medical reasons.

Q. When should the hepatitis B vaccination be offered to employees?

A. The hepatitis B vaccination must be made available within 10 working days of initial assignment, after appropriate training has been completed. This includes arranging for the administration of the first dose of the series. In addition, see page 17 for vaccination of designated first aiders.

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

A. No. 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. Routine post-vaccination serological testing is not currently recommended by the CDC unless an employee has had an exposure incident, and then it is also to be offered at no cost to the employee.

Q. If an employee declines the hepatitis B vaccination, can the employer make up a declination form?

A. If an employee declines the hepatitis B vaccination, the employer must ensure that the employee signs a hepatitis B vaccination declination. The declination’s wording must be identical to that 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.

Q. Can employees refuse the vaccination?

A. Employees have the right to refuse the hepatitis B vaccine and/or any post-exposure evaluation and follow-up. Is important to 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.

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

A. OSHA does not have jurisdiction over the issue.

Q. Is a routine booster does of hepatitis B vaccine required?

A. Because the U.S. Public Health Service (USPHS) does not recommend routine booster doses of hepatitis B vaccine, 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.

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

A. 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.

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

A. 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.

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

A. The employer must identify and document the source individual if know, 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.

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

A. 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.

Q. When is the exposed employee’s blood tested?

A. 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.

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

A. 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 further require evaluation and treatment. All other findings or diagnoses must be kept confidential and not included in the written report.

Q. What type of counseling is required following an exposure incident?

A. The standard requires that post-exposure counseling be given to employees following an exposure incident. Counseling should include USPHS recommendations for 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. In addition, counseling must be made available regardless of the employee’s decision to accept serological testing.

Q. What information about exposure incidents is recorded on the OSHA 300 Log?

Revision 10/02 A. All work-related needlestick injuries and cuts from sharp objects that are contaminated with another person’s blood or other potentially infectious materials must be recorded. Enter the case on the 300 Log as an injury. To protect the employee’s privacy, do not enter the employee’s name. Enter the case on the sharps injury log or enter comparable data on the OSHA 300 Log.