330 Blood Borne Pathogens
330.01 Scope
330.02 Definitions Applicable to this Section
330.03 General Requirements
330.04 Exposure Control
330.05 Methods of Compliance
330.06 Personal Protective Equipment
330.07 Housekeeping
330.08 Regulated Waste
330.09 Laundry
330.10 HIV and HBV Research Laboratories
330.11 Hepatitis B Vaccination
330.12 Post-Exposure Evaluation and Follow-Up
330.13 Labels, Color Coding, and Signs
330.14 Information and Training

330. BLOOD BORNE PATHOGENS (7-1-97)

01. Scope: (7-1-97)

a. Blood Borne pathogen exposure shall conform to all other applicable requirements of this standard, as well as the following provisions. Nothing in this standard shall be construed to prohibit better or otherwise safer conditions than specified herein. (7-1-97)

b. This section applies to all occupational exposure to blood or other potentially infectious materials as defined in sub-section 330.02 of this section. (7-1-97)

02. Definitions: For definitions of other terms used in this section, see sub-section 010 of this standard. (7-1-97)

a. Blood refers to human blood, human blood components, and products made from human blood. (7-1-97)

b. Blood Borne Pathogens are pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to hepatitis B virus (HBV) and human immunodeficiency virus (HIV). (7-1-97)

c. Clinical Laboratory is a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. (7-1-97)

d. Contaminated is the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. (7-1-97)

e. Contaminated Laundry is laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. (7-1-97)

f. Contaminated Sharps are any contaminated object that can penetrate the skin, but not limited to needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. (7-1-97)

g. Decontamination is the use of physical or chemical means to remove, inactivate, or destroy blood borne pathogens on a surface or item where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. (7-1-97)

h. Engineering Controls are controls that isolate or remove the blood borne pathogens hazard from the workplace (e.g., sharps disposal containers, self sheathing needles). (7-1-97)

i. Exposure Incident is a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties. (7-1-97)

j. Hand Washing Facilities is a facility providing an adequate supply of running potable water, soap, and single use towels or hot air drying machines. (7-1-97)

k. Licensed Health Care Professional is a person whose legally permitted scope of practice allows them to independently perform activities required by sub-section 330.09 of this section for hepatitis B vaccination and post exposure evaluation and follow-up. (7-1-97)

l. HBV is hepatitis B virus. (7-1-97)

m. HIV is human immunodeficiency virus. (7-1-97)

n.  Needleless Systems means a device that does not use needles for:  (7-1-03)

i.  The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established;    (7-1-03)

ii.  The administration of medication or fluids; or  (7-1-03)

iii.  Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.

o. Occupational Exposure is the 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. (7-1-97)

p. Other Potentially Infectious Materials are the following human body fluids: semen, vaginal secretions, cerebra spinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; any unfixed tissue or organ (other than intact skin) from a human (living or dead); HIV containing cell or tissue cultures, organ cultures, and HIV or HBV containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. (7-1-97)

q. Parenteral is the piercing of mucous membranes`or the skin barrier through such events as needle sticks, human bites, cuts, and abrasions. (7-1-97)

r. Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) not intended to function as protection against a hazard are not considered to be protective equipment. (7-1-97)

s. Regulated Waste is liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. (7-1-97)

t. Research Laboratory is a laboratory producing or using research laboratory scale amounts of HIV or HBV. Research laboratories may produce high concentrations o HIV or HBV but not the volume found in a production facility. (7-1-97)

u.  Sharps with Engineered Sharps Injury Protections means a nonneedle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident.  (7-1-03)

v. Source Individual is any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions; trauma and accident victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components. (7-1-97)

w. Sterilize is the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. (7-1-97)

x. Universal Precautions is an approach to infection control. According to the concept all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other blood borne pathogens. (7-1-97)

y. Work Practice Controls are controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two (2) handed technique). (7-1-97)

03. General Requirements: (7-1-97)

a. The employer shall take all steps necessary to control the spread of blood borne pathogens. (7-1-97)

b. Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which a determination between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials. (7-1-97)

c. Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall be also used. (7-1-97)

d. Engineering controls shall be examined and maintained or replaced on a regular schedule to ensure their effectiveness. (7-1-97)

e. Employers shall provide hand washing facilities which are readily accessible to employees. (7-1-97)

f. When the provision of hand washing facilities is not feasible, the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleansers or toweletts are used, hands shall be washed with soap and running water as soon as feasible. (7-1-97)

g. Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment. (7-1-97)

h. Employers shall ensure that employees wash hands and any other skin with soap and water, of flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials. (7-1-97)

i. Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. (7-1-97)

j. Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets, or on counter-tops or bench-tops where blood or other potentially infectious materials are present. (7-1-97)

04. Exposure Control: (7-1-97)

a. Each employer having an employee(s) with occupational exposure as defined in sub-section 330.02.n of this section shall establish a written exposure control plan designed to eliminate or minimize employee exposure. (7-1-97)

b. The exposure control plan shall contain at least the following elements: the exposure determination; the schedule and method of implementation for methods of compliance; HIV and HBV research laboratory procedures; hepatitis B vaccination, post exposure, and follow-up procedures; communication of hazards to employees; and the procedure for the evaluation of circumstances surrounding exposure incidents. (7-1-97)

c. The exposure control plan shall accessible to employee's, their representatives, and representatives of the Department. (7-1-97)

d. The exposure control plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which effect occupational exposure and to reflect new or revised employee positions with occupational exposure. (7-1-97)

e. Each employer who has an employee(s) with occupational exposure shall prepare an exposure determination. This exposure determination shall contain the following: a list of job classifications in which all employees in those job classifications have occupational exposure; a list of job classifications in which some employees have occupational exposure; and a list of all tasks and procedures or groups of closely related tasks and procedures in which occupational exposure occurs and that are performed by employees in the listed job classifications. (7-1-97)

f. The exposure determination shall be made without regard to the use of personal protective equipment. (7-1-97)

05. Methods of Compliance: (7-1-97)

a. When ever possible sharps with self shielding or retractable needles shall be used.  Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed. Shearing or breaking of contaminated needles is prohibited. EXCEPTION: Contaminated needles and other sharps may be bent, recapped, or removed if the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure. Such bending, recapping, or needle removal must be accomplished through the use of a mechanical device or a one handed technique. (7-1-00)

b. Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly processed. These containers shall be: puncture resistant; labeled or color coded in accordance with this section; leak proof on the sides and bottom; and shall not be stored or processed in a manner that requires employees to reach by hand into the containers where sharps have been placed. (7-1-97)

c. All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. (7-1-97)

d. Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited. (7-1-97)

e. Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, or shipping. (7-1-97)

f. The container for the storage, transport, or shipping of blood or other potentially infectious materials shall be labeled or color coded in accordance with this section. (7-1-97)

g. If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping. Secondary over-pack containers shall be marked or color coded in accordance with this section. (7-1-97)

h. If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture resistant in addition to meeting the requirements of sub-section 330.05.b of this section. (7-1-97)

i. Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment is not feasible. A readily observable label that complies with the requirements of this section shall be attached to the equipment stating which portions remain contaminated. The employer shall ensure that this information is conveyed to all effected employees, the servicing representative, and/or the manufacture, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken. (7-1-97)

06. Personal Protective Equipment: (7-1-97)

a. When there is potential occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered appropriate only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for he duration of time which the protective equipment will be used. (7-1-97)

b. The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee's professional judgment that in the specific instance its use would have prevented the delivery of health care or public safety services would have posed an increased hazard to the safety or co-worker. When the employee makes this judgment, the circumstances shall be investigated in order to determine whether changes can be instituted to prevent such occurrences in the future. (7-1-97)

c. The employer shall ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the work-site or is issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or similar alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided. (7-1-97)

d. The employer shall supply personal protective equipment that is for a single employee only. Personal protective equipment is not to be for community use. (7-1-97)

e. The employer shall clean, launder, and dispose of required personal protective equipment at no cost to the employee. (7-1-97)

f. The employer shall repair or replace protective equipment as needed to maintain its effectiveness, at no cost to the employee. (7-1-97)

g. If a garment(s) is penetrated by blood or potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible. (7-1-97)

h. All personal protective equipment shall be removed prior to leaving the work area. (7-1-97)

i. When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination, or disposal. (7-1-97)

j. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood or other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in sub-section 330.06.n. below; and when handling or touching contaminated items or surfaces. (7-1-97)

k. Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. (7-1-97)

l. Disposable (single use) gloves shall not be washed or decontaminated for reuse. (7-1-97)

m. Utility gloves may be decontaminated for reuse if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised. (7-1-97)

n. If an employer in a blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer shall: periodically reevaluate this policy; make gloves available to all employees who wish to use them for phlebotomy; and not discourage the use of gloves for phlebotomy. The employer shall require that gloves be used for phlebotomy in the following circumstances: when the employee has cuts, scratches, or other breaks in the skin; when the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individual; and when the employee is receiving training in phlebotomy. (7-1-97)

o. Masks in conjunction with eye protection devices, such as goggles or glasses with solid side shields, or chin length face shields, shall be worn whenever splashes, spray, splatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose or mouth contamination can be reasonably anticipated. (7-1-97)

p. Appropriate protective clothing such as , but not limited to, gowns, aprons, laboratory coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated. (7-1-97)

q. Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g. autopsies, orthopaedic surgery). (7-1-97)

07. Housekeeping: (7-1-97)

a. Employers shall ensure that the work-site is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in he area. (7-1-97)

b. All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. (7-1-97)

c. Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning. (7-1-97)

d. Protective coverings such as plastic wrap, aluminum foil, or imperviously backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the work shift if they may have become contaminated during the shift. (7-1-97)

e. All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected an decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. (7-1-97)

f. Broken glassware which may be contaminated shall not be picked up directly with the hands. It shall be cleaned up using mechanical means, such as a brush and dust pan, tongs, or forceps. (7-1-97)

08. Regulated Waste: (7-1-97)

a. Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: closeable; puncture resistant; leak proof on the sides and bottom; and labeled or color coded in accordance with this section. (7-1-97)

b. During use, containers for contaminated sharps shall be: easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries); maintained upright throughout use; and replaced routinely and not allowed to overfill. (7-1-97)

c. When moving containers of contaminated sharps from the area of use, the containers shall be: closed immediately prior to removal or replacement to prevent spillage or protrusion of the contents during handling, storage, transport, or shipping; place in a secondary container if leakage is possible. The second container shall meet the requirements of sub-section 330.08.a. of this section. (7-1-97)

d. 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. (7-1-97)

e. 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 this section; and closed prior to removal to prevent spillage or protrusion of the contents during handling, storage, transport, or shipping. (7-1-97)

f. If contamination of the regulated waste container occurs, it shall be placed in a second container that meets the requirements of sub-section 330.08.e. of this section. (7-1-97)

g. Disposal of all regulated waste shall either be incinerated or decontaminated by a method such as autoclaving in accordance with the applicable regulations of the United States and the State of Idaho to effectively destroy blood borne pathogens. (7-1-97)

09. Laundry: (7-1-97)

a. Contaminated laundry shall be handled as little as possible with minimum of agitation before the actual washing process. (7-1-97)

b. 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 (these operations may take place at the laundry). (7-1-97)

c. Contaminated laundry shall be placed and transported in bags or containers labeled or color coded in accordance with this section. When a facility used 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. (7-1-97)

d. The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment. (7-1-97)

e. 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 shall place such laundry in bags or containers which are labeled or color coded in accordance with this section. (7-1-97)

10. HIV and HBV Research Laboratories: (7-1-97)

a. This subsection applies to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of this section and this standard. (7-1-97)

b. Laboratory doors shall be kept closed when work involving HIV or HBV is in progress. (7-1-97)

c. Contaminated materials that are to be decontaminated at a site away from he work area shall be placed in durable, leak proof, labeled or color coded container that is closed before being removed from the work area. (7-1-97)

d. Access to the work area shall be limited to authorized persons. Written policies and procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific requirements, and who comply with all entry and exit procedures shall be allowed to enter the laboratory, specimen areas, and work areas. (7-1-97)

e. When other potentially infectious materials, specimens, or infected animals are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors, see Figure 330.10-A. (7-1-97)

FIGURE 330.10-A

See Section 170 of this standard for color coding (orange or red orange background with contrasting symbol and letters).

f. All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physical containment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench. (7-1-97)

g. Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered. (7-1-97)

h. Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals, specimens, and when making hand contact with other potentially infectious materials is unavoidable. (7-1-97)

i. Before disposal all waste from work areas and from animal rooms shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy blood borne pathogens. (7-1-97)

j. Vacuum lines shall be protected with liquid disinfectant traps and high efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained and replaced as necessary. (7-1-97)

k. Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle locking syringes or disposable syringe needle units (i.e., the needle is integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture resistant container and autoclaved or decontaminated before reuse or disposal. (7-1-97)

l. All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. (7-1-97)

m. A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person. (7-1-97)

n. A bio-safety manual shall be prepared and periodically reviewed and updated at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them. (7-1-97)

o. Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols. (7-1-97)

p. Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually. (7-1-97)

q. HIV and HBV research laboratories shall meet the following criteria: each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area; an autoclave for decontamination of regulated waste shall be available. (7-1-97)

11. Hepatitis B Vaccination: (7-1-97)

a. The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have potential occupational exposure, and post exposure evaluation and follow-up to all employees who have had an exposure incident. (7-1-97)

b. The employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post exposure evaluation and follow-up, including prophylaxis, are: made available at no cost to the employee; made available to the employee at a reasonable time and place; performed by or under the supervision of a licensed physician or by or under the supervision of other licensed health care professional; and provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by sub-section 330.11 of this standard. (7-1-97)

c. The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee. (7-1-97)

d. Hepatitis B vaccination shall be made available after the employee has received the training required in sub-section 330.14 of this section and within ten (10) working days of initial assignment to all employees who have potential occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody tested has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. (7-1-97)

e. The employer shall not make participation in a pre-screening program a prerequisite for receiving hepatitis B vaccination. (7-1-97)

f. If the employee initially declines hepatitis B vaccination but at a later, while still covered under this standard, decides to accept the vaccination, the employer shall make available hepatitis B vaccination at that time. (7-1-97)

g. The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the following statement: "I understand that due to my potential exposure to blood or other potentially infectious materials I may run the risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have potential occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me." (7-1-97)

h. If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with sub-section 330.11.b. of this section. (7-1-97)

12. Post-Exposure Evaluation and Follow-Up: (7-1-97)

a. Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow up, including at least the following elements: (7-1-97)

b. Identification of the source individual; (7-1-97)

c. Testing of the source individual's blood as soon as feasible and after consent is obtained in order to determine HIV and HBV infectivity, when the source individual is already known to be infected with HBV or HUV, testing for the source individual's known HBV or HIV status need not be repeated; (7-1-97)

d. The results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. (7-1-97)

e. The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained. (7-1-97)

f. If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least nighty (90) days. If, within nighty (90) days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible. (7-1-97)

g. The employer shall provide post exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service. (7-1-97)

h. The employer shall provide counseling and evaluation of reported illness. (7-1-97)

i. The employer shall ensure that the health care professional responsible for the employee's hepatitis B vaccination is provided a copy of this section. (7-1-97)

j. The employer shall ensure that the health care professional evaluating an employee after an exposure incident is provided the following information: (7-1-97)

i. A copy of this section; (7-1-97)

ii. A description of the exposed employee's duties as they relate to the exposure incident; (7-1-97)

iii. Documentation of the route(s) of exposure and circumstances under which exposure occurred; (7-1-97)

iv. Results of the source individual's blood testing, if available; (7-1-97)

v. All medical records relevant to the appropriate treatment of the employee including vaccination status which are the employer's responsibility to maintain. (7-1-97)

k. The employer shall obtain and provide the employee with a copy of the evaluating health care professional's written opinion within fifteen (15) days of the completion to the evaluation. (7-1-97)

l. The health care professional's written opinion for hepatitis B vaccination shall be limited to whether hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination. (7-1-97)

m. The health care professional's written opinion for post exposure evaluation and follow-up shall be limited to the following information: that the employee has been informed of the results of the evaluation; and that the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment. (7-1-97)

n. All other findings or diagnoses shall remain confidential and shall not be included in the written report. (7-1-97)

13. Labels, Color Coding, and Signs: (7-1-97)

a. Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport, or ship blood or other potentially infectious materials, except as provided in sub-section 330.13.e of this section. (7-1-97)

b. Labels required by this section shall include the following legend, see Figure 330.13-A. (7-1-97)

FIGURE 330.13-A

c. These labels shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting color. (7-1-97)

d. Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. (7-1-97)

e. Red bags or red containers may be substituted for labels. (7-1-97)

f. Containers of blood, blood components, or blood products that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from the labeling requirements of sub-section 330.13 of this section. (7-1-97)

g. Labels required for contaminated equipment shall be in accordance with sub-section 330.13 and shall also state which portions of the equipment remain contaminated. (7-1-97)

h. Regulated waste that has been decontaminated need not be labeled or color coded. (7-1-97)

14. Information and Training: (7-1-97)

a. Employers shall ensure that all employees with potential occupational exposure participate in a training program which must be provided at no cost to the employee and conducted during working hours. (7-1-03)

b. Training shall be provided at the time of initial assignment to tasks where potential occupational exposure may take place and at least annually thereafter. (7-1-03)

c. Annual training for all employees shall be provided within one year of their previous training. (7-1-97)

d. Employers shall provide additional training when changes such as modifications of tasks or procedures or institution of new tasks or procedures affect the employee's potential occupational exposure. The additional training may be limited to addressing the new exposures created. (7-1-97)

e. Material appropriate in content and vocabulary to the educational level, literacy, and language of employees shall be used. (7-1-03)

f. The training program shall contain at a minimum the following elements: (7-1-97)

i. An accessible copy of this section and an explanation of its contents; (7-1-97)

ii. A general explanation of the epidemiology and symptoms of blood borne diseases; (7-1-97)

iii. An explanation of the modes of transmission of blood borne pathogens; (7-1-97)

iv. An explanation of the employer's exposure control plan and the means by which the employee can obtain a copy of the written plan; an explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials; (7-1-97)

v. An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment; (7-1-97)

vi. Information on the types, proper use, location, removal, handling, decontamination, and disposal of personal protective equipment; (7-1-97)

vii. An explanation of the basis for selection of personal protective equipment; (7-1-97)

viii. Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge; (7-1-97)

ix. Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials; (7-1-97)

x. An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and medical follow-up that will be made available; (7-1-97)

xi. Information on the post exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident; (7-1-97)

xii. An explanation of the signs and labels and/or color coding; (7-1-97)

xiii. An opportunity for interactive questions and answers with the person conducting the training session. (7-1-97)

g. The person conducting the training shall be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address. (7-1-97)

h. Employees in HIV or HBV research laboratories and production facilities shall receive, in addition to the required training in sub-section 330.14.f of this section, the following training: (7-1-97)

i. The employer shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV; (7-1-97)

ii. The employer shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV; (7-1-97)

iii. The employer shall provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed; (7-1-97)

iv. The employer shall assure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated. (7-1-97)