**BLOODBORNE PATHOGEN**

**EXPOSURE CONTROL PLAN**

NCI-Frederick

Revised: October 2003

Supersedes: September 2002 edition

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> Joseph P. Kozlovac, M.S., CBSP, RBP
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Carol Ingraham Tobias, MBA, BSN
>
> Approval: EHS [\_\_\_\_\_\_\_\_\_\_]{.underline}
>
> Randall Morin, Dr.P.H., RBP

Table of Contents

> [Page No.]{.underline}
>
> Introduction\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....
> 1
>
> Part I:
>
> A. Purpose
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....
> 1
>
> B. Scope
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> 1
>
> C. Applicability
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> 1
>
> D. Responsibility for Policy
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\..... 1
>
> E. Definitions
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....
> 2
>
> Part II:
>
> A. Policy
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
> 5
>
> B. Responsibilities
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
> 5
>
> C. Additional
> Procedures\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
> 9
>
> 1\. Eligibility for Medical
> Programs\...\...\...\...\...\...\...\...\...\.... 9
>
> 2\. Methods of
> Compliance\...\...\...\...\...\...\...\...\...\...\...\...\.... 10
>
> 3\. Personal Protective
> Equipment\...\...\...\...\...\...\...\...\..... 12
>
> 4\. Cleaning, Disinfection, and Decontamination\...\..... 13
>
> 5\. Additional Requirements: HIV/HBV Research
>
> Laboratories and Production Facilities\...\...\...\...\..... 14
>
> 6\. Communication of
> Hazards\...\...\...\...\...\...\...\...\...\...\.... 17
>
> 7\. Institutional Biosafety Committee HIV
>
> Subcommittee
> Policy\...\...\...\...\...\...\...\...\...\...\...\...\...\..... 19
>
> 8\. HIV Surveillance
> Program\...\...\...\...\...\...\...\...\...\...\...\... 20
>
> 9\. Hepatitis B Vaccination Program \...\...\...\...\...\...\...\...
> 23
>
> 10\. Accident Reporting
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\... 24
>
> 11\. Recordkeeping
> \...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
> 25
>
> Attachment1- Hepatitis B and HIV Surveillance Eligibility and Addition
> to Pathogen Registration
>
> Addenda

# Introduction

> The NCI-Frederick is committed to the safety and health of its
> employees. In keeping with this philosophy, a comprehensive employee
> safety program has been established, an integral portion of which is
> this Bloodborne Pathogen Exposure Control Plan.

**PART I:**

A. [Purpose]{.underline}

> The Bloodborne Pathogen Exposure Control Plan describes the policies,
> which have been adopted by this institution regarding the prevention
> of the transmission of the Human Immunodeficiency Virus (HIV), the
> Hepatitis B Virus (HBV) and other bloodborne pathogens in the
> workplace. These policies, based on guidelines established by the
> Occupational Safety and Health Administration (OSHA) and the Maryland
> OSHA Code of Maryland Regulations (COMAR), are designed to eliminate
> employee occupational exposure to infectious agents.

B. [Scope]{.underline}

The Bloodborne Pathogen Exposure Control Plan encompasses all personnel
who have occupational exposure to HIV, HBV and other bloodborne
infectious diseases. The plan complements the Institutional Biosafety
Committee (IBC) registration programs for human pathogens, human blood
and body fluids, and recombinant DNA.

C. [Applicability]{.underline}

> This plan applies to all personnel at the NCI-Frederick who work with
> HIV, HBV, human blood, and other potentially infectious material.
> Additionally SAIC-Frederick employees located at offsite facilities
> that have an occupational exposure to blood-borne pathogens are also
> covered by this plan.

D. [Responsibility for Policy]{.underline}

Environment, Health and Safety Program (EHS) and Occupational Health
Services (OHS) will be responsible for maintaining, approving, and
incorporating revisions to this policy. All proposed revisions must be
submitted to EHS for review. EHS and OHS will review and update the plan
annually.

E. [Definitions]{.underline}

1\. \"Blood\": human blood, human blood components, and products made
from human blood.

2\. \"Bloodborne pathogens\": microorganisms that are present in human
blood and can cause disease in humans who are exposed to blood
containing the pathogen. Of particular relevance are the HBV and the
HIV.

3\. \"Contaminated\": the presence or the reasonably anticipated
presence of blood or other potentially infectious materials on an item
or surface.

4\. \"Contaminated sharps\": mean objects that can penetrate the skin
(needles, scalpels, broken glass, broken capillary tubes, etc.) and have
or may have blood or other potentially infectious material on their
surfaces.

5\. \"Decontamination\": the use of physical or chemical means to
remove, inactivate, or destroy bloodborne pathogens on a surface to the
point where they are no longer capable of transmitting infection and the
surface is rendered safe for handling, use, or disposal.

6\. \"Engineering controls\": equipment or other items (e.g., sharps
disposal containers, hoods) that isolate the bloodborne pathogen\'s
hazard in the workplace.

7\. \"Exposure incident\": a specific eye, mouth, other mucous membrane,
non-intact skin, or parenteral contact with blood or other potentially
infectious material that results from the performance of an employee\'s
duties.

8\. \"Occupational exposure\": [reasonably anticipated]{.underline}
skin, eye, mucous membrane, or parenteral contact with blood or other
potentially infectious materials that [may]{.underline} result from the
performance of an employee\'s duties.

9\. \"Other potentially infectious materials\":

> \(1\) Human body fluids: semen, vaginal secretions, cerebrospinal
> fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal
> fluid, amniotic fluid, or any body fluid that is suspect or visibly
> contaminated with blood, all body fluids in situations where it is
> difficult or impossible to differentiate between body fluids; and
>
> \(2\) Any unfixed tissue or organ from a human living or dead; and
>
> \(3\) Any cell or tissue culture or organ culture that contains HIV,
> HBV or any other bloodborne pathogen; and
>
> \(4\) Culture medium or other solutions containing HIV, HBV or any
> other bloodborne pathogen; and
>
> \(5\) Blood, organs or tissues from experimental animals infected with
> HIV, HBV or any other bloodborne pathogen.

(6) Established human cell lines unless characterized to be free of
    bloodborne pathogens. Documentation of such verification is the
    responsibility of the primary investigator and must be provided to
    the Biological and Laboratory Safety Office, EHS.

10\. \"Parenteral\": piercing mucous membrane or skin through events
such as a needlestick, human bite, cut, or abrasion.

11\. \"Personal protective equipment\": specialized clothing or devices
worn by an employee for protection against a hazard.

12\. \"Production facility\": an area established to provide
industrial-scale, large-volume or high concentration production of HIV
or HBV.

13\. \"Regulated waste\": liquid or semi-liquid blood; 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; pathological and
microbiological wastes containing blood or other potentially infectious
materials.

14\. \"Research laboratory\": any area producing or using large amounts
of HIV or HBV but not in the volume found in production facilities.

15\. \"Source individual\": 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, individuals who donate or sell
blood or blood components, clients of drug and alcohol treatment
facilities and clients in institutions for the developmentally disabled.
Source materials may include cell lines, repository cell lines, and
unfixed tissues or organs.

16. \"Special medical waste\": blood and blood products, sharps,
    pathological or microbiological specimens, or other research samples
    perceived to contain contaminated laboratory materials.

17. "Standard Precautions": Infection control philosophy which expands
    the coverage of Universal Precautions by recognizing that any body
    fluid may contain infectious microorganisms.

18. \"Sterilize\": the use of a physical or chemical procedure to
    destroy all microbial life.

19. \"Universal Precautions\": an approach to infection control whereby
    all human blood and other potentially infectious materials are
    treated as if known to be infected with HIV, HBV, and other
    bloodborne pathogens.

20. \"Work practice controls\": methods that reduce the likelihood of
    exposure by altering the manner in which a task is performed (e.g.,
    no recapping of needles).

**PART II:**

A. [Policy]{.underline}

> Exposure to infectious agents represents a potential health hazard. It
> is the policy of the NCI-Frederick that employees are entitled to
> information regarding the potential health hazards of any material
> used in their laboratories. This policy statement establishes a formal
> program to provide health and safety information and training in the
> proper handling of infectious agents in accordance with 29 CFR
> 1910.1030, Occupational Exposure to Bloodborne Pathogens. A copy of
> the OSHA standard can be obtained at the offices of EHS in Building
> 426 in accordance with the \"Communications of Hazards to Employees\"
> guideline, 29 CFR 1910.1030 (g) 2(vii). A copy of the OSHA Bloodborne
> Pathogen Standard can also be found at the OSHA website www.OSHA.gov.

B. [Responsibilities]{.underline}

1\. Senior management is responsible for ensuring the implementation of
the Bloodborne Pathogen Exposure Control Plan. All employees, including
contractor and government employees, who meet the criteria in the OSHA
standard are included in its provisions.

2\. The Director, Environment, Health and Safety Program is responsible
for general administration of this program. The Manager, Occupational
Health Services is responsible for vaccination ( i.e. Hepatitis B) and
medical surveillance programs, including post-exposure medical
evaluation and follow-up.

3\. The Biological Safety Officer (BSO), who serves as the Institutional
Biosafety Committee Secretary, is responsible for the registration of
work involving pathogens, human blood and other potentially infectious
material, recombinant DNA, or transgenic animals and the implementation
of this Bloodborne Pathogen Exposure Control Plan. The BSO also serves
on the Institutional Biosafety Committee to advise on the effective
mitigation of hazards inherent during work with bloodborne pathogens.

4\. EHS is responsible for:

> a\. assisting the investigator in the design of the laboratory and the
> selection of laboratory practices and engineering controls that ensure
> a safe working environment;
>
> b\. providing technical guidance to any person responsible for matters
> pertaining to laboratory safety;
>
> c\. inspecting laboratories to assess compliance with policies for the
> safe conduct of work involving infectious agents;
>
> d\. investigating all reported accidents which result in the exposure
> of personnel or the environment to infectious agents and recommending
> corrective action to prevent recurrence;
>
> e\. supervising decontamination procedures where accidents have
> resulted in contamination of laboratory areas;
>
> f\. developing information and conducting training programs to educate
> and implement methods for the safe handling of infectious agents;
>
> g\. In conjunction with OHS, ensuring that medical monitoring programs
> are adopted;
>
> h\. maintaining a file of reference materials available to employees
> on the hazards, safe handling, storage, and disposal of infectious
> agents;
>
> I. determining when employee exposure monitoring may be required, and
> conducting such monitoring as needed.

5\. OHS is responsible for.

. Coordinating with EHS and individual supervisors to determine
eligibility of individuals and job descriptions for medical monitoring
programs.

. Coordinating and reviewing all new Hepatitis B and HIV Surveillance
enrollment applications with EHS.

. Conducting baseline, periodic, and termination medical monitoring as
indicated.

. Maintaining records of medical interventions and exposure incidents as
directed by 29 CFR 1910.1030.

. When appropriate, conducting comprehensive vaccination programs for
identified biological hazards.

. In conjunction with EHS, training affected individuals and groups on
specific medical monitoring programs.

. In the event of an exposure, conducting a confidential post-exposure
medical evaluation and follow-up.

h\. Attending IBC meetings and making a written recordation on medical
surveillance requirements.

6\. The Director, Facilities Maintenance and Engineering (FME), is
responsible for overseeing a program of routine testing, certification
and maintenance for certain equipment including:

> a\. biological safety cabinets upon installation, when relocated and
> at least annually thereafter;
>
> b\. emergency showers that are to be tested semi-annually.

7\. Laboratory and department supervisors are responsible for:

> a\. acquiring the knowledge and information needed to recognize and
> control infectious agents in the laboratory;
>
> b\. registering all work with human pathogens, human blood or other
> potentially infectious materials and recombinant DNA. A list of all
> registered laboratories is maintained by EHS to identify areas where
> biohazards may exist. The responsible investigator completes the
> registration form, identifies the agent(s), the laboratory procedures,
> the employees working in the laboratory, and the specific safety
> policies used and enforced. Program registration is approved for three
> years. Updates shall be submitted to EHS whenever changes in
> personnel, practices, facilities or equipment are made. Registrations
> will be renewed every three years upon submission of a completed
> current registration form.
>
> c\. In conjunction with EHS, selecting and employing laboratory
> practices and engineering controls that prevent or limit occupational
> exposure to infectious agents;
>
> d\. informing those supervised employees listed on the principal
> investigator\'s registration forms, of the potential hazards
> associated with the use of infectious agents used in the laboratory.
>
> e\. instructing employees in safe laboratory practices and the use of
> protective equipment, and in the procedures for dealing with accidents
> involving infectious agents;
>
> f\. supervising, implementing and enforcing the safety performance of
> the staff to ensure that the necessary and safe laboratory practices
> and equipment are used;
>
> g\. arranging for immediate medical attention by OHS and reporting to
> EHS any accident that results in a spill or exposure incident;
>
> h\. provide OHS and EHS with the following information: a description
> of the exposed employee\'s duties as they relate to the exposure
> incident, documentation of the route(s) of exposure and circumstances
> under which the exposure occurred, and results of the source
> individual or material\'s pathogenicity testing, if available;
>
> I. assisting representatives of EHS in investigating accidents;
>
> j\. investigating and reporting to EHS any problems pertaining to the
> operation and implementation of laboratory practices or equipment;
>
> k\. ensuring the proper labeling of agents when they are removed from
> their primary containers;
>
> l\. ensuring that eyewash stations located in their area are tested
> routinely;
>
> m\. notifying OHS of persons who are working with human pathogens,
> human blood or other potentially infectious material;

n.  informing emergency response personnel of potential hazards within a
    laboratory in the event of an accident, fire or any emergency
    situation;

o\. properly indicating on job requisition what infectious agents the
employer could be exposed to and the Biosafety level of the laboratory.

8\. Employees are responsible for:

> a\. Understanding and complying with safety guidelines, regulations,
> and procedures required for the task assigned;
>
> b\. reporting unsafe conditions to the principal investigator,
> immediate supervisor, or EHS;
>
> c\. reporting to the principal investigator or immediate supervisor
> all facts pertaining to any accident resulting in exposure of
> personnel or the environment to biological agents;

d\. following first aid procedures in the event of an exposure incident;

e\. routinely testing eyewash stations located in their area;

> f\. reviewing and signing the program\'s SOPs to document that she or
> he understands and will follow recommended safety practices.

C. [Additional Procedures]{.underline}

1\. Eligibility for Medical Programs

> Eligibility for appropriate medical surveillance programs and
> immunizations will be determined by OHS according to occupational
> exposure. See Attachment #1, *Hepatitis B and HIV Surveillance
> Eligibility and Addition to Pathogen Registration*, if you have
> employees that are eligible for registration in a medical surveillance
> program.
>
> a\. Employees that have occupational exposure to blood or other
> potentially infectious materials are included in this program. These
> employees may include those in the following categories:

Animal Care Protective Services

Laboratory Research Occupational Health

Clinical Research Repository

Clinicians Safety

Production Technician Student Intern

Service Worker

b\. Individuals with a job category that is not included in the above
list of potential occupationally exposed employees, but do perform tasks
which may result in an occupational exposure, will be identified by
their individual unit supervisor/director. Each department will document
the specific tasks that cause these employees to have an occupational
exposure to bloodborne pathogens. These employees will be covered by
this exposure control plan and must participate in training and other
aspects of the exposure control plan.

> c\. The following are procedures in which occupational exposure may
> occur:
>
> 1\. direct work with bloodborne pathogens such as HIV or HBV
>
> 2\. direct work with blood or other potentially infectious material
>
> 3\. inoculation of research animals with live HIV, HBV, or any
> bloodborne pathogen
>
> 4\. necropsy of animals experimentally infected with HIV, HBV, or any
> human bloodborne pathogen
>
> 5\. administration of first-aid during emergency responses to
> accidents or injuries
>
> 6\. direct patient care.
>
> 7\. direct handling of special medical waste.

2\. Methods of Compliance

> a\. [Universal Precautions]{.underline} will be followed by all
> personnel as a minimum. All body fluids, as defined by this plan, will
> be considered potentially infectious materials. EHS recommends that
> laboratories adhere to the tenets of "Standard Precautions" in regards
> to laboratory operations involving materials of human origin.

b.  [Engineering Controls]{.underline} - The facilities and equipment at
    the NCI-Frederick are designed and selected in accordance with the
    NCI-Frederick Health, Safety and Environmental Compliance Program
    Manual, the CDC/NIH publication Biosafety in Microbiological and
    Biomedical Laboratories, current edition and the NIH Recombinant DNA
    Guidelines, current edition. Biological safety cabinets serve as
    primary barriers and are required for all work with known or
    suspected infectious materials. The selection of primary and
    secondary barriers is based on the pathogenicity of the agent,
    planned laboratory manipulations, and the potential for
    aerosolization.

> Whenever possible and practicable new safety technology, such as
> shielded needles, self-sheathing needles, retracting needles or
> needleless systems, will be utilized.
>
> Puncture resistant, labeled or color-coded, leakproof sharps
> containers, available from the warehouse, must be used for the safe
> disposal of needles and other sharps. No recapping, bending, breaking,
> or further manipulation of needles is permitted.
>
> i\. Needles and other sharps must not be jammed into the containers in
> such a way as to overfill the containers. Fill only to the indicated
> line on the container or until the container is 3/4ths full, whichever
> is less (Ft. Detrick Regulation 385-4, Management of Medical Waste,
> August 1, 1996).
>
> ii\. All sharps containers must be securely closed before removal or
> disposal. Sealed sharps containers shall be clearly labeled and
> discarded as medical waste.

iii. If outside contamination of the primary container occurs, or if the
     specimen could puncture the primary container, then the primary
     container shall be placed within a second container which prevents
     leakage during handling, processing, storage, transport, or
     shipping and is labeled or color-coded according to the
     requirements of the OSHA Bloodborne Pathogen standard.

> EHS reviews purchase requests for certain laboratory engineering
> controls such as biological safety cabinets and chemical fume hoods.
> Monitoring of facility design and the certification of engineering
> controls is performed by FME in conjunction with EHS via site visits,
> inspections, and preventive maintenance.
>
> Laboratory renovations and construction plans are reviewed by EHS to
> ensure appropriate design, placement of biological safety cabinets,
> containment, traffic patterns, etc.
>
> c\. [Work Practice Controls]{.underline} - Emphasis is placed on safe
> laboratory practices and techniques to minimize the risk of exposure
> to pathogens in the workplace. Safetygrams and the NCI-Frederick
> Health, Safety and Environmental Program Manual detail safe laboratory
> practices.
>
> i\. Handwashing facilities must be provided in all laboratories.
> Washing is an effective means of physical removal and dilution of
> infectious agents. Immediately after an exposure incident to skin or
> mucous membranes has occurred, employees must wash affected area with
> soap and water and/or flush mucous membranes with copious amounts of
> water.
>
> Employees must wash their hands immediately after removal of gloves or
> other personal protective equipment.
>
> ii\. The use of scalpels and glass pipettes in laboratories is
> strongly discouraged. Plastic tubes and pipettes or safe sharps such
> as knives with retractable blades are recommended.
>
> iii\. **PIPETTING BY MOUTH IS NOT PERMITTED. \***
>
> \* Mouth pipetting is not permitted except for work involving certain
> embryologic procedures using special apparatus with two in-line
> filters and after special permission is granted by the Biological
> Safety Officer.
>
> iv\. Eating, drinking, smoking, applying cosmetics, handling contact
> lenses, or wearing contact lenses without goggles, safety glasses, or
> face shields is prohibited in laboratory work areas.
>
> v\. Food and drink must not be stored in laboratory refrigerators,
> freezers, shelves, cabinets or on countertops/benchtops.
>
> vi\. All procedures involving blood or other potentially infectious
> materials shall be performed in a biological safety cabinet if there
> is potential for splashing, spraying, spattering, or generation of
> droplets or infectious aerosols.
>
> vii\. Specimens of blood or other potentially infectious materials
> shall be placed in containers that prevent leakage during collection,
> handling, processing, storage, transportation, or shipping. Relevant
> state and federal regulations will be followed.

viii. Equipment will be decontaminated and tagged in accordance with
      NCI-Frederick internal SOP \"Equipment Decontamination and Safety
      Clearance\" before repair or service by FME or an outside
      contractor.

> [Safety Devices]{.underline} - OHS chairs a committee whose goal is to
> eliminate or reduce exposure to bloodborne pathogens. This committee
> meets at least annually to review the use of medical devices designed
> to reduce needlestick injuries. Consideration and use of appropriate,
> commercially available, and effective safer devices is documented. The
> committee describes the devices identified for employee use, the
> method(s) used to evaluate those devices, and justification for the
> selection of the appropriate safety device. This committee also
> solicits input from employees performing procedures using needle safe
> devices regarding the identification, evaluation, and selection of
> effective engineering controls, including safe medical devices.

3\. Personal Protective Equipment (PPE):

Appropriate PPE is provided for employee use where there is occupational
exposure. PPE will be considered appropriate only if it does not permit
any potentially infectious material to pass through onto clothing, skin,
eyes, mouth, or other mucous membranes. Minimal PPE to be worn is
determined by the organisms and chemicals that are used, methods of use,
and the biological containment level. Additional PPE may be required by
the specific SOPs of the program.

The employer shall insure that appropriate PPE is in the appropriate
sizes and is readily accessible at no charge to the employee.

> Gloves, labcoats, face shields or masks, mouthpieces, resuscitation
> bags, or other ventilation devices, protective suits, scrubs, and
> safety eyewear are provided at no cost to the employee. Individuals
> entering laboratories must comply with the established requirements
> for the area.

If a garment has been penetrated by blood or other potentially
infectious material, the garment shall be removed immediately. All PPE
must be removed before leaving the work area.

> a\. Gloves must be worn when the employee might have skin contact with
> blood, other potentially infectious materials, mucous membranes,
> non-intact skin, or when handling contaminated items or surfaces. Any
> glove must be replaced when torn, punctured, or when the ability to
> function as a barrier is compromised. Disposable gloves shall not be
> reused.
>
> b\. Masks, eye protection, and/or face shields will be worn whenever
> splashes, spray, spatter, or droplets of potentially infectious
> materials may be generated.
>
> c\. Gowns, aprons, and other protective clothing will be worn as
> dictated by the tasks performed and the degree of exposure
> anticipated.

d.  Surgical caps, head protection, and shoe covers will be worn in
    instances when gross contamination might reasonably be anticipated.

4\. Cleaning, Disinfection, and Decontamination

a\. The BSL-1 and BSL-2 laboratories are maintained and cleaned
routinely by custodial services. Laboratory personnel are responsible
for cleaning and maintenance In BSL-3 suites. Appropriate disinfectants
are determined based on the particular agent involved and the type of
surfaces to be cleaned or decontaminated. Work surfaces in laboratories
will be decontaminated at the beginning and end of each work day and
whenever there is an overt spill. Protective coverings on work surfaces
(plastic wrap, aluminum foil, or plastic-backed absorbent paper) should
be changed regularly and whenever contaminated. Reusable receptacles
(bins, pails, cans) will be decontaminated regularly by the laboratory
staff. Red-banded cans used for the disposal of special medical waste
will be decontaminated immediately upon visible contamination.

> b\. The safety clearance/work authorization tag system shall be used
> to assure proper decontamination of equipment and instrumentation
> before repair. EHS or other authorized personnel will sign all tags
> when biological materials, infectious agents, human blood or other
> potentially infectious materials have been used.

c\. Infectious Waste Disposal - Special Medical Waste

> A special medical waste program has been developed in coordination
> with the U.S. Army Garrison which meets all federal and state
> requirements. BL-3 labs must autoclave or otherwise render
> non-infectious all waste before it leaves the area. Laboratory waste
> known to be or potentially contaminated with infectious material is
> special medical waste and will be decontaminated, autoclaved and/or
> incinerated. Special medical waste is placed in red-banded receptacles
> and transported by the Army to the incinerator. Puncture proof
> needles/sharps disposal containers are used throughout the facility.
> All sharps containers must be securely closed before removal or
> disposal. Sealed sharps containers shall be clearly labeled and
> discarded as medical waste.
>
> Contaminated laundry (uniforms, towels, clothing) when removed in the
> laboratory, should be placed in appropriate containers and autoclaved
> before being sent for cleaning. Care will be taken in handling the
> unautoclaved articles (e.g., holding them away from one\'s clothing)
> so as not to cause further contamination.

5\. Additional Requirements: HIV/HBV Research Laboratories and
Production Facilities

> a\. This applies to research laboratories and production facilities
> engaged in the culture, production, concentration, experimentation,
> and manipulation of HIV and HBV. This 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 the standard.
>
> b\. According to 29 CFR 1910.1030(e), all HIV and HBV research
> laboratories and production facilities shall follow these additional
> requirements:
>
> i\. The work practice controls, personal protective equipment,
> decontamination procedures and special medical waste handling as
> described in this policy.
>
> ii\. Laboratory doors shall be kept closed when work involving HIV or
> HBV is in progress.
>
> iii\. Contaminated materials that are to be decontaminated at a site
> away from the work area shall be placed in a durable, leakproof,
> labeled or color-coded container that is closed before removal from
> the work area.
>
> iv\. Access to the work area shall be limited to authorized persons.
> Authorized persons shall comply with entry/exit procedures, understand
> the potential biohazard and meet any specific entry requirements.
>
> v\. A biohazard warning sign shall be posted on all access doors
> whenever work with bloodborne pathogens, OPIM or infected animals are
> in progress.
>
> vi\. All activities involving bloodborne pathogens, and/or OPIM shall
> be conducted in biological safety cabinets or other physical
> containment devices within the containment area. No work with these
> materials shall be conducted on an open bench.
>
> vii\. 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 laundering.
>
> viii\. Avoid skin contact with OPIM. Gloves shall be worn when
> handling infected animals, bloodborne pathogens and OPIM.
>
> ix\. Vacuum lines shall be protected with liquid disinfectant traps
> and high-efficiency particulate air (HEPA) filters that are
> hydrophobic on the inlet side. Filters shall be checked routinely and
> replaced as necessary.

x.  Hypodermic needles and syringes shall be used only for parenteral
    injection and aspiration of fluids from laboratory animals and
    diaphragm bottles. Whenever possible and practicable new safety
    technology, such as shielded needles, self-sheathing needles,
    retracting needles or needleless systems, will be utilized. Needles
    shall not be bent, sheared, resheathed or removed from the syringe
    following use. The needle/syringe unit shall be placed promptly in
    an approved sharps container and decontaminated before disposal.

> xi\. Spills shall be appropriately contained and cleaned up by
> personnel trained and equipped to work with bloodborne pathogens and
> OPIM.
>
> xii\. A spill or accident resulting in an exposure incident shall be
> reported immediately to OHS, the laboratory supervisor or the
> Principal Investigator.
>
> xiii\. A biosafety manual shall be prepared or adopted and
> periodically reviewed and updated at least annually or more often if
> necessary. Personnel shall be advised of potential hazards, required
> to read instructions on practices and procedures and shall be required
> to follow them.

xiv. Containment equipment (such as certified biological safety
     cabinets, respirators, centrifuge safety cups, special protective
     clothing, and containment caging for animals) shall be used for all
     activities with bloodborne pathogens and OPIM that pose a threat of
     exposure to droplets, splashes, spills or aerosols.

xv. Biological safety cabinets shall be certified when installed,
    whenever they are moved, and at least annually.

> c\. HIV and HBV research laboratories are required by 29 CFR
> 1910.1030(e)(3) to follow these additional requirements:
>
> i\. Each laboratory shall contain a facility for hand washing and an
> eye wash facility which is readily available within the work area.
>
> ii\. An autoclave for decontamination of regulated waste shall be
> available.
>
> d\. HIV and HBV production facilities as outlined in 29 CFR
> 1910.1030(e)(4), shall also:
>
> i\. Work area shall be separated from areas that are open to
> unrestricted traffic flow within the building with a self-closing,
> double-door airlock or change room.
>
> ii\. Work surfaces, doors, ceilings, floors, and walls shall be
> water-resistant for easy cleaning. Penetrations in these surfaces
> shall be easily sealable for easy decontamination.
>
> iii\. Each laboratory shall contain a facility for hand washing and an
> eye wash facility that is readily available within the work area. The
> sink shall be elbow, foot or automatically operated and shall be
> located near the door of the work area.
>
> iv\. An autoclave for decontamination of regulated waste shall be
> available within or as near as possible to the work area.

v\. A ducted air ventilation system shall be provided. This system shall
create directional airflow that draws air into the work area through the
entry area. Exhaust air shall not be recirculated to any other area of
the building, shall be discharged to the outside, and shall be dispersed
away from occupied areas and air intakes. Proper directional airflow
shall be verified.

> vi\. Access doors to the work area shall be self-closing.

c\. Additional Initial Training:

I. Employees working in HIV and HBV research laboratories and production
facilities must demonstrate proficiency in standard microbiological
practices and safe techniques before working with HIV or HBV. It is the
responsibility of the manager, program director, and supervisor to
provide training on safe handling techniques and practices. Only after
proficiency has been demonstrated may the employee participate in work
activities involving infectious agents.

> ii\. Each employee working in an HIV and HBV research laboratory or
> production facility must submit to EHS, through their supervisor, an
> Additional Initial Training Form to indicate their experience and/or
> proficiency in handling pathogenic materials. The form can be obtained
> from EHS.

6\. Communication of Hazards

a\. Warning Labels

> Warning labels with the fluorescent orange-red biohazard symbol with
> contrasting lettering or symbols shall be affixed to containers of
> regulated waste: to refrigerators and freezers which contain human
> pathogens, human blood or other potentially infectious material; and
> other containers used to store, transport or ship human pathogens,
> human blood or other potentially infectious material
>
> i\. Required 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.
>
> ii\. Individual containers of blood or OPIM that are placed in a
> labeled container for storage, transport, shipment, or disposal are
> exempt from the labeling requirement.

iii. Regulated waste that has been decontaminated does not need to be
     labeled or color-coded.

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iii. Red bags or red containers may be substituted for labels.

iv. Labels required for contaminated equipment shall be in accordance
    with this paragraph and shall also state which portions of the
    equipment remain contaminated.

b\. Signs

> The biosafety containment level is determined by the biological agent,
> its concentration, and the laboratory manipulations planned. A
> biohazard sign with the fluorescent orange-red biohazard symbol
> indicating the containment level, the responsible investigator, the
> supervisor, their phone numbers, and the required PPE must be posted
> at the entrance to work areas.
>
> c\. Training and Education

i\. All employees with occupational exposure must attend a training
program sponsored by EHS. Training shall be provided at the time of
initial assignment and annually thereafter. Documentation of attendance
shall be maintained by the EHS.

ii\. Training shall include: information on prevention of exposure, the
epidemiology and symptoms of bloodborne diseases; the modes of
transmission of bloodborne pathogens; methods for exposure
determination; use and limitations of engineering controls; work
practices; PPE; information on the types, use, selection, removal,
handling, decontamination, and disposal of PPE; appropriate use of
biohazard signs; and information on the availability, efficacy, safety,
and information on the hepatitis B vaccine.

iii\. Training shall also include information on the appropriate action
to take and persons to contact in an emergency (e.g., a spill) involving
blood or other potentially infectious materials. Emergency first-aid,
methods of reporting the incident, and medical follow-ups shall be
stressed. Information on post-exposure evaluation and follow-up, which
the employer is required to provide, is included.

iv\. The employee\'s supervisor, manager, and/or program director are
responsible for reviewing with the employee all specific intra-
departmental safety policies and procedures as well as expectations of
compliance. This information must be reviewed and updated annually.
Individual programs are responsible for maintaining documentation of
this requirement. Additional training must be provided when tasks or
procedures are modified or instituted thereby affecting the occupational
exposure of the employee.

7\. Institutional Biosafety Committee HIV Subcommittee Policy

> The following statement addresses the findings of the IBC HIV
> Subcommittee regarding the [Morbidity and Mortality Weekly
> Report]{.underline} (Vol. 36, No. 2S Supplement, August 21, 1987)
> "Prevention of HIV Transmission in Health Care Settings".
>
> Since it is understood that health care workers also wear gloves under
> conditions where contact with blood or body fluids is anticipated, it
> is clear that lesions on the hand automatically prevent an individual
> from handling materials or equipment which contain or may contain
> infectious virus. The reason for this is to protect even against the
> low probability occurrence of defective gloves or the inadvertent
> penetration of the gloves by virus-containing fluids. In contrast to
> the health care workers, there should be no circumstance in the
> laboratory where direct contact with infectious material is
> anticipated. Under BSL-3 conditions, automatic prohibition from
> working in a BSL-3 laboratory should be limited to lesions of the
> hands, face, or neck. The judgment on whether a worker with suspect or
> healing lesions may work (or return to work) is the responsibility of
> Occupational Health Services. This requires an expert medical opinion
> and is not a matter for the affected individual or their supervisor to
> decide independently. The judgment must be made with safety as the
> overriding factor.
>
> In cases where a decision may not be obvious, e.g., lesions on the
> arm, leg, or torso, it may be reasonable for certain activities to be
> permitted while others should be ruled out. By analogy with the
> penetrated glove situation, the potential for direct contact with
> virus-containing material should be evaluated. This must involve a
> discussion between laboratory worker, supervisor, and the Manager,
> Occupational Health Services.

8\. HIV Surveillance Program

a\. Introduction

> The HIV surveillance program is available to employees of the
> NCI-Frederick who work with known or suspected live HIV or are
> potentially exposed to live HIV in the laboratory. The program is
> voluntary with no requirement to enroll. It is not a research program,
> but is intended to be a surveillance program for employee benefit.
> Refusal to participate in the program will not adversely affect
> employment status. Refusal to participate will neither preclude
> participation at a later date nor will it affect an employee\'s
> treatment in the event of an occupational exposure. Declining
> participation does not compromise an employee\'s benefits under
> Worker\'s Compensation where it is demonstrated that an infection has
> been acquired during the performance of official duties.
>
> b\. Eligibility
>
> Eligible participants are identified by the principal investigator who
> registers all personnel that work with HIV in the laboratory. The
> registration form is forwarded to Biological Safety for review to
> determine which employees qualify for the program. In addition, OHS is
> advised at the time of the initial assignment of an employee to tasks
> where occupational exposure may take place. The NCI-Frederick
> Hepatitis B and HIV surveillance eligibility form will be forwarded to
> OHS by the supervisor upon assignment of personnel. The Manager for
> Occupational Health Services, who is the HIV surveillance program
> director, notifies the employee of an appointment in OHS and enrolls
> the employee in the program. Employees who stop working with live HIV
> because of a move, change in job description, or a discontinuation of
> a project will remain in the program for one year following the
> change.
>
> c\. Testing
>
> Samples are taken from participants at periodic intervals and analyzed
> by ELISA testing for antibodies to HIV. The samples are handled so as
> to minimize the likelihood of accidental disclosure of any test
> results.
>
> Testing is done by a commercial licensed and approved testing facility
> and requires such facility to provide timely testing, confirmatory
> capability, and timely reporting. In addition to the tube being sent
> for testing, a second tube is drawn and stored in a serum storage bank
> for validation testing, if that is necessary. Serum samples collected
> are sent in a batch to the testing facility. The results of the
> testing are hand delivered by a courier to OHS in a sealed envelope.
> Confirmatory tests will be performed on indeterminate and positive
> results.
>
> Employees working in HIV production areas are offered confidential
> testing twice yearly. Other HIV workers are offered confidential
> testing annually. Additional testing at more frequent intervals is
> offered following an exposure incident.

d.  Notification of Results

> Participants will be informed of negative laboratory results by mail.
> Notification will be sent to an address indicated by the participant.
>
> Results of the test should be received within four to six weeks of the
> venipuncture for any screening test done in this program. Individuals
> who have not received results within this time frame are instructed to
> contact OHS, ext. 1096.
>
> The program director will contact individuals with confirmed positive
> or indeterminate results to inform them of the need for further
> evaluation and arrange a time for a consultation. In the meeting the
> program director will personally convey the test results to the
> program participant. Arrangements will be made for a visit to an
> infectious disease specialist who interviews and examines the
> employee, does appropriate testing and reviews the results of the
> tests. The consultant helps the employee arrange for any further
> follow-up through a private doctor or appropriate community resources.
> Information collected by the consultant will not be communicated to
> OHS or any other person at NCI-Frederick without written permission of
> the employee. It is solely for the benefit of the employee.
>
> e\. Overt Exposure
>
> Quite apart from participation in this program, it is incumbent upon
> all employees to report immediately any accidents resulting in
> potential exposure to HIV. Immediate first aid shall be administered
> at the worksite. Percutaneous injuries are vigorously scrubbed and
> soaked for 20 minutes with povidone-iodine, 10% solution (e.g.
> Betadine). Mucous membranes are irrigated for 15 minutes with normal
> saline. Consultation regarding chemoprophylaxis will be done on an
> individual basis.
>
> Following the Public Health Service (PHS) provisional recommendations
> for chemoprohylaxis after occupational exposure to human
> immunodeficiency virus (HIV) published on June 7, 1996 (Updated May,
> 1998), OHS implemented several new procedures to provide timely and
> appropriate response to an exposure event at the NCI-Frederick, 24
> hours per day, 7 days per week.
>
> A clinical staff member of OHS, NCI-Frederick, provides an assessment
> and initial administration of post-exposure prophylaxis to exposed
> NCI-Frederick employees at our facility within 1-2 hours of an HIV
> exposure event if needed.
>
> Post exposure testing may include blood samples being taken and tested
> at time zero and at the six week, three, six, and twelve month
> intervals. If results are negative at twelve months after an accident,
> the individual may elect to withdraw from the program.

f\. Confidentiality

> OHS strictly protects the privacy of individuals participating in this
> program by withholding their names and other identifying information
> from all persons not directly connected with the conduct of the
> surveillance program. Confidentiality of test results and the names of
> any persons who test positive will be maintained consistent with the
> reporting, investigatory, and any legal and contractual obligations on
> the Operations and Technical Support (OTS) Contractor. Confidentiality
> of test results obtained as part of accident follow-up likewise will
> be maintained.
>
> g\. Enrollment
>
> Employees who participate in this program understand and agree to the
> following:
>
> Prior to enrollment in the program, employees will be counseled by OHS
> to ensure understanding of all provisions of the program including
> individual responsibilities. The State of Maryland mandates an
> informed consent form be signed prior to any HIV testing.
>
> In the event of a positive result, a pre-employment sample will be
> tested and virus isolation attempted if circumstances warrant. The
> program director will also provide initial counseling in the event of
> a positive result.
>
> In the event of a positive result, employees will cooperate in any
> interviews that may be required to identify any risk factors that may
> be relevant to transmission of HIV, such as life style and laboratory
> practices.
>
> Accident reporting programs and policies will be followed.
>
> Employees understand that confidentiality of test results and other
> relevant information will be maintained consistent with the OTS
> Contractor\'s reporting, investigatory, and any legal contractual
> responsibilities.
>
> Employees who are eligible to participate in this program must
> indicate whether they accept or decline participation.

9\. Hepatitis B Vaccination Program

> a\. Introduction
>
> Infection by hepatitis B virus (HBV) is the most frequent occupational
> risk among health care workers. The significant factors for nosocomial
> infection are the intensity of exposure to human blood and the
> duration of that exposure. The Immunization Practices Advisory
> Committee of the Public Health Services has recommended that health
> care workers who have contact with human blood or blood products be
> vaccinated against HBV. Immunization should take place as early in
> their careers as possible. In 1992, the OSHA issued rules and
> regulations about occupational exposure. The standard requires
> employers to identify employees who may have occupational exposure and
> to offer them the hepatitis B vaccine within ten working days of their
> initial assignment.

b\. Eligibility

> The hepatitis B vaccine is offered without charge by OHS to all
> NCI-Frederick employees occupationally at risk for acquiring the
> infection and who lack serologic evidence of pre-existing protective
> levels of antibody.
>
> HBV infection in pregnant women may result in severe disease for the
> mother and a markedly increased risk of chronic infection for the
> fetus. Unvaccinated pregnant women with possible occupational exposure
> should be strongly encouraged to Consult with their obstetrician
> before beginning the vaccination series.

c\. Enrollment

> Supervisors must identify employees working with human blood or body
> fluids and other potentially infectious materials and notify OHS.
> Notification of OHS for employees should occur on the job requisition.
> OHS will provide a supervisor enrollment form to clarify pathogen
> registration information. Hepatitis B vaccine will be offered within
> ten working days of the employee\'s initial assignment. After
> explanation of the program by OHS, each enrollee must complete a
> consent form to receive the vaccine. The form is incorporated into the
> employee\'s medical records. If an employee elects not to receive the
> vaccine, a signed form declining the vaccine is required. If the
> employee requests the vaccine at a later time, the vaccination series
> will be provided.

d\. Initial vaccination series

> The vaccination series consists of three intradeltoid injections. The
> first dose is administered at the time of enrollment in the program.
>
> For those employees who lack previous serologic evidence of protective
> levels of antibody, the second and third doses are administered one
> and six months from the first dose.

e\. Serologic monitoring and booster doses

> An initial serologic screen for antibodies is performed prior to the
> administration of the first dose
>
> All participants will be serologically screened for anti-HBs within 6
> months of administration of the 3rd dose of vaccine. The need for
> additional doses of the vaccine and screening for anti-HBs is based
> upon the anti-HBs S/N value.

10\. Accident Reporting, Post Exposure Evaluation and Follow-up

> **Potential Exposure incident at NCI-Frederick at Ft. Detrick or
> offsite facilities in Frederick (Government, Charles River and
> SAIC-Frederick Employees):**

Immediately following a potential exposure incident - a cut, splash or
other laboratory accident - the employee is to report to OHS. When
prudent, laboratory staff should secure the exposed laboratory area.

> OHS is on-call 24 hours a day for these incidents. During office hours
> of Monday through Friday 8:15 AM -- 5:00 PM the employee is to report
> in person at OHS, Building 426, on the NCI-Frederick Campus, x1096.
> After hours, the employee must contact Protective Services, x1091 for
> the on-call OHS health care provider who will meet the employee at
> OHS. In all cases, the OHS provider will perform an interview and
> medical evaluation of the person(s) involved and collect the following
> information: documentation of the route of exposure, the circumstances
> under which the exposure occurred, identification and documentation of
> the source individual or material and baseline testing of the source.
> Postexposure baseline and follow-up of the worker includes collection
> and testing of blood for HBV, HCV, HTLV, or HIV serological status, as
> indicated, post-exposure prophylaxis, if indicated, counseling, and
> evaluation of any reported illnesses. EHS will investigate the
> incident to determine whether an exposure actually occurred and
> prepare a safety evaluation report to indicate the possible need for
> additional engineering controls, barriers, etc.
>
> **Potential exposure of SAIC-Frederick employees at offsite facilities
> not located in Frederick or at NIH:**

Response to potential exposure incidents that occur at off-site
facilities outside of the immediate Frederick Area will be performed by
the nearest available medical center. Off-site facilities include those
located in Gaithersburg, Shady Grove, Rockville, and nearby areas.
Incidents occurring in laboratories located between Bethesda and
Frederick should report to Shady Grove Hospital or Suburban Hospital for
post exposure assessment and treatment. Telephonic notification is made
to OHS at the NCI-Frederick as soon as possible.

**Potential exposure of SAIC-Frederick employees occurring on the NIH
campus** :

Exposures shall be immediately reported to Occupational Medical Services
(OMS) in Building 10. The staff of OMS will make a determination as to
disposition. Telephonic notification is made to OHS at the NCI-Frederick
as soon as possible.

11\. Recordkeeping

> a\. Medical Records
>
> A medical record will be maintained by OHS of all individuals with
> occupational exposure. The record will include the name and social
> security number of the employee, and hepatitis B vaccination status.
> If there has been a documented exposure incident, copies of the
> accident form, medical evaluation, follow-up procedures, the
> employer's copy of the healthcare professional's written opinion, and
> a copy of the information provided to the healthcare professional will
> be included in the medical records. The medical record will be kept
> for the duration of employment plus thirty (30) years. The retrovirus
> exposure surveillance program results are maintained in a separate
> file in OHS.
>
> This information must be kept strictly confidential. No information
> will be disclosed or reported without the written consent of the
> employee, except where required by law.
>
> b\. Training Records
>
> Records will be maintained for three (3) years from the date of the
> training. The records will include an outline or summary of the
> information presented and the dates of the training sessions. Records
> will also include the names and job of all persons attending the
> training sessions and the names and qualifications of the trainer(s)
> will accompany the training records. Those attending the session will
> sign an attendance sheet or EHS will receive and electronic record
> when individuals successfully complete the web based training.

c.  Sharps Injury Log

> If an exposure involving human blood or OPIM and a sharp occurs, OHS
> will maintain a sharps injury log. That log will be maintained in a
> manner that protects the privacy of the employee. The log will contain
> information regarding the type and brand of device involved in the
> incident, the location of the incident, and description of the
> incident.

**ATTACHMENT 1**

**Hepatitis B and HIV Surveillance Eligibility**

**and Addition to Pathogen Registration**

<http://home.ncifcrf.gov/ehs/uploadedFiles/PATHREG.pdf>