**SAFETY PROGRAM OVERVIEW AND TRAINING**

**INTRODUCTION**

The mission of the Clinical Services of the Laboratory of Pathology (LP)
of the National Cancer Institute is to achieve the highest level of
quality in diagnostics, education and research. These goals are
supported by a commitment to high standards of laboratory safety. The LP
has established a partnership with the clinical and research community
at the National Institutes of Health to expand the scope of our
expertise. This is turn will ensure the achievement of our goal to be a
globally recognized center of excellence for clinical diagnostics,
disease research, and pathology education. The manual is designed to
promote the highest standards of safety practices, in keeping with our
mission, vision and departmental philosophy.

This manual was revised for the year 2002 in an effort to consolidate,
condense and streamline the information in our previous manual so that
it is easier to find information and insure that we are covering all
regulatory and NIH safety issues for the employees working in the
Clinical Services of LP. In 2003, revisions were made to address new
safety standards of various regulatory and accrediting bodies and
placing the material on the web for quick and easy access for LP
employees.

The contents of this manual have been standardized with the exception of
variable content \[e.g., chemical inventory, material safety data sheets
(MSDS), etc.\] for all the clinical laboratories sections and copies are
available in each section/unit and office. Note: Each Laboratory Section
has a separate Chemical Inventory and Material Safety Data Sheets
(MSDS). MSDS may also be viewed online using links found at
<http://www.nih.gov/od/ors/ds/msds.html>

All employees must review the content of both safety manual and the CC
Emergency Management Plan (web and/or printed material) and sign a log
indicating they are familiar with its contents. Other very useful web
based sources include:

-   [Division of Safety](http://www.nih.gov/od/ors/ds/safetymgt.html)

-   [Office of Research Services](http://www.ors.od.nih.gov/)

-   [Clinical Center Safety
    Committee](http://intranet.cc.nih.gov/ccc/safety/index.html)

-   [NIH Manual Chapters](http://www1.od.nih.gov/oma/manualchapters/)

-   [CC Emergency Management
    Plan](http://intranet.cc.nih.gov/od/emergencyplan/)

-   [NIH Policy 3015, Admittance of Children to Hazardous
    Areas](http://www1.od.nih.gov/oma/manualchapters/intramural/3015/).

The information contained in this manual may be reproduced; however,
reference to any specific commercial products, process, or service by
trade name, trademark, manufacturer, or otherwise, does not necessarily
constitute or imply its endorsement, recommendation, or favoring by the
United States Government.

**ROLES, RESPONSIBILITIES, AND REQUIREMENTS**

Prevailing local, state and federal (e.g., OSHA, EPA, etc) regulations
are reviewed by the NIH Division of Safety (DS) (496-5291). DS insures
that methods for disposal of all solid and liquid wastes are in
compliance with local, state and federal regulations and is involved in
hazardous waste reduction programs. The mercury reduction program may be
viewed at <http://orf.od.nih.gov/nomercuryhome.htm> and information
regarding the recycling program may be viewed at
<http://www.nih.gov/od/ors/ds/recycle/index.htm>. The DS assisted with
the preparation of this manual to be sure that the LP is in compliance
with regulations.

The **[Occupational Medical
Service](http://www.nih.gov/od/ors/ds/oms.html) (OMS)** provides a
variety of work-related medical services to the NIH community. Their
services include preplacement medical evaluations, work-related
immunizations and laboratory testing, evaluation and care for medical
emergencies and occupational injuries, Workers\' Compensation support
services, a range of Employee Assistance Program services, and CPR
training. Although employees should report all work-related injuries and
illnesses to OMS, the service is particularly concerned that injuries
that could result in potentially life-threatening infections be reported
immediately (examples include injuries involving human body fluids). OMS
is located in the ACRF\'s 6th floor clinic. The clinic is open Monday
through Friday from 7:30 am to 5:00 pm and can be reached at 496-4411.
OMS health care providers can be reached after clinic hours for
potentially life-threatening injuries by calling the NIH Page Operator
at 496-1211. If OMS is not available, call 116 for first aid and
transportation to Suburban Hospital if necessary. Code Blue is available
24 hours a day at 111.

The **Hospital Epidemiology Service (HES)** is responsible for the
hospital-wide infection prevention program, aimed at preventing
nosocomial infections through improved management. This goal includes
preventing transmission of infection from patients to patient-care staff
or to hospital visitors. The responsibilities of HES include: 1)
performing routine surveillance activities to detect the occurrence of
nosocomial infections, 2) ensuring that patients with communicable
illnesses are placed on appropriate isolation precautions, 3)
investigating all potential outbreaks of infection in the Clinical
Center, and 4) educating personnel regarding infection control
procedures, including Universal Precautions to prevent the transmission
of blood-borne pathogens.

The HES staff is available to all employees to assist in making
decisions relevant to the prevention and control of infection in
patients as well as personnel. The Clinical Center isolation policy
includes Universal Precautions in the management of blood or body fluids
from all patients. Questions about Universal Precautions, about
isolation of infected patients, about policies or procedures relevant to
infection prevention and/or control, about the management of patients
with resistant pathogens or tuberculosis, or any question dealing with
the risk of transmitting infection among patients or staff should be
directed to this service. Patients or personnel with varicella zoster
virus infection, suspected or diagnosed tuberculosis,
oxacillin-resistant Staphylococcus aureus, or vancomycin-resistant
enterococcus should be reported to the HES as soon as possible. In
addition, an Isolation Guidelines flipchart devised by the HES is
located at all nursing units and patient care areas as a reference. The
CC Isolations Guidelines ("flipchart") is available at
<http://www.cc.nih.gov/hes/CC/flipchrt/flipchrt.html> HES may be
contacted by calling 496-2209 or through the signal page operator
496-1211.

The **Safety Support Section** of the **Occupational Safety and Health
Branch** maintains surveillance programs of hazardous chemicals (e.g.,
formaldehyde, xylene, glutaraldehyde). They are responsible for
evaluating employee exposure and ensuring compliance with OSHA
standards. Call 496-3457 or 496-3353 for more information.

The LP Chief has ultimate responsibility for the safety of employees
within the department. However, as a team, all LP employees are
responsible for maintaining a safe work environment. This includes
knowledge of safe work practices and disposal of all real or potential
hazards of wastes. In addition, all employees must use appropriate
personal protective equipment and control devices based on the criteria
established for their individual sections.

Each **Section/Unit Chief** appoints a member from his/her area to serve
as a **Safety Officer** for their area and serve on the LP Safety
Committee. The Chief or designate of each section/unit is responsible
for additional safety policies and training of employees in their area
of responsibility which are unique to their areas and not specified in
this general safety manual.

**Supervisors** will work with committee members to schedule time and
location for specific training requirements for their areas. The
supervisors are expected to support the Safety Committee members and
allow them to work on safety issues during their normal work day.

The Clinical Lab Manger will **Chair the Safety Committee**. The Chair
of the Safety Committee carries out the following responsibilities:

-   Attends and reports safety incidents at the monthly Quality
    Improvement Committee meetings.

-   Attends Clinical Center Safety Committee meetings.

-   Coordinates chemical exposure monitoring.

-   Coordinates environmental assessments and training needs with the
    NIH Office of Research Services Divisions of Safety and Public
    Safety.

-   Coordinates quarterly LP Safety Committee meetings.

-   Works with the LP Chief, the Director of Clinical Service
    Operations, Section/Unit Chiefs, Administrative Laboratory Manager,
    Supervisors, DS, EMS, and OMS to insure CAP, JCAHO and all other
    regulatory compliance.

The **LP Safety CommitteeMembersand Chair**, designated in Appendix A,
work together to carry out the following responsibilities:

-   Assist supervisors with safety orientation of new employees.

-   Coordinate evacuation drills (e.g., Fire Drills).

-   Coordinate in-service safety training sessions (e.g., Fire Safety)
    for LP.

-   Coordinate the function verification of chemical and biological fume
    hoods and other protective equipment.

-   Function as the Chemical Hygiene Officer for Hazardous Chemicals.
    Responsibilities include: training employees in the elements of the
    chemical hygiene plan, documenting that each chemical in the
    laboratory has been evaluated for carcinogenic potential,
    reproductive toxicity, and acute toxicity, and verifying that
    polices are in place which define specific handling requirements of
    hazardous chemicals.

-   Function as the Floor Monitor Warden for evacuation procedures. [See
    NIH Manual \# 1430 "NIH Occupant Evacuation
    Plan"](http://www1.od.nih.gov/oma/manualchapters/management/1430/)

-   Maintain appropriate postings in section.

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-   Monitor and document training compliance and notify section chiefs
    of any delinquencies.

-   Participate in annual review and evaluation of the effectiveness of
    the LP Chemical Hygiene plan.

-   Refer difficult or complex questions to a higher level or different
    department (e.g., ORS, DS, OMS, and HES) based on area of expertise.
    Working with these departments, the committee will serve as a link
    to transfer information and assist in trouble shooting problems and
    concerns and assist with 1) evaluation of effectiveness of
    engineering and work practice controls to significantly reduce or
    eliminate exposure to bloodborne pathogens during laboratory testing
    and 2) the selection of products and implementation of work
    practices that reduce the risk of allergic reactions to job-related
    exposure of natural rubber latex in gloves and other products.

-   Review and document safe work practices during the annual safety
    audit and physical inspection.

-   Update and maintain safety manual and policies.

-   Update safety manual as needed in collaboration with the Chief of LP
    and Divisions of Safety and Public Safety. Insure that copies of
    revised or new polices are in all manuals and notify Chiefs and
    Supervisors of changes .

The **Program Assistant** assigned to the Director of Clinical
Operations is responsible for:

-   Assisting the safety committee with monitoring of training
    compliance.

-   Attending the safety committee meetings.

-   Maintaining central files of safety documentation.

-   Performing clerical duties relating to the management of the LP
    Safety Program.

-   Acting as the custodian of the CD-Rom titled: "Introduction to Lab
    Safety - Computer Based Training Course".

At the present time, no known radioactive materials are used in LP for
clinical diagnosis.  In the future, if such materials will be used, a
Radiation Safety Officer would be appointed to oversee the safe and
efficient use of the material.  Employees working near researchers using
radioactive materials should be aware that risk from the exposures are
minimal, and insure that radiation safety policies and procedures are
being followed. Employees who may receive radioactive specimens must
follow specific procedures related to these specimens.

Radiation Safety Manuals are also available for further reference.  In
addition, the LP Chief currently serves as the Chair of the Radiation
Safety Committee for the entire NIH community. Any questions regarding
radiation safety or radioactive specimens should be directed to the
ORS assigned Health Physicist located at
<http://www.nih.gov/od/ors/ds/rsb/hp/index.html> or by calling 496-5574.

**DOCUMENTATION**

The safety committee member of each section maintains all safety
documentation for his or her appointed area of responsibility. Copies of
the Orientation checklists, Universal Precautions and TB training
documentation, chemical exposure monitoring, chemical inventory and
chemical evaluation, electrical ground checks, and accident reports must
be sent to the Program Support Assistant for Clinical Operations. All
documentation must be readily available for inspection purposes and
tracking of compliance. The program assistant will maintain files and
assist the safety committee with monitoring compliance.

**REPORTING OF SAFETY CONCERNS**

Safety concerns may be reported to the Section Chief, Section
Supervisor, Safety Officer, Chair of the Safety Committee, or LP Chief
at any time. Refer difficult or complex questions to a higher level or
different department (e.g., ORS, DS, OMS, and HES) based on area of
expertise. All concerns should be forwarded in writing to the Chair of
the Safety Committee for review and discussion with the Safety
Committee. The Chair of the Safety Committee will report a summary of
findings and recommendations to the Quality Improvement Committee.

**TRAINING**

All new employees performing clinical services are required to complete
the following during their orientation:

-   Complete Safety Orientation Checklist

-   Complete Universal Precautions & Tuberculosis training

-   Read and Sign this Safety Manual

-   Read and Sign Clinical Center Emergency Plan

-   Complete the radiation orientation training

-   Review the content of both safety manual and the CC Emergency
    Management Plan (web and/or printed material) and sign a log
    indicating they are familiar with its contents

All employees performing clinical services are required to:

-   Repeat the annual Universal Precautions training

-   Repeat annual Fire Safety Training & Evacuation/Fire Drill

-   Repeat Radiation Orientation every three years

Specific training for specimens contaminated with radiation takes place
during orientation. Every three years, all employees performing clinical
services are required to attend a Radiation Safety Orientation conducted
by ORS.

It is recommended that new employees performing clinical services:

-   Take Introduction to Lab Safety Computer Based Training (CBT)
    Course.

-   Attend Lab Safety at the NIH (must take CBT as prerequisite).

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-   Attend Working Safely with HIV and Bloodborne Pathogens in the
    Research Laboratory

Fellows, Residents, Visiting Scientists and employees performing
research may have additional requirements not covered in this manual
(e.g., above recommended classes are required if performing research at
NIH). See your supervisor for more information.

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**ANNUAL FIRE SAFETY & FIRE EVACUATION DRILLS**

**Overview:** The Safety Committee coordinates in-services for Fire
Safety Training conducted by the NIH fire marshal. Evacuation Training
covers emergency procedures to be employed before, during, and following
a fire incident. The designated meeting place for all LP employees
(except Clinical Cytogenetics) evacuating the building is the parking
lot behind Building 1. The designated meeting place for all Clinical
Cytogenetics' employees evacuating the building is the parking lot near
the Blood Bank. Fire drills are conducted with the guidance of the fire
prevention inspector and he/she or designate completes required
documentation for his/her section. Fire Prevention Safety (FPS) monitors
the effectiveness of the drill and the CC Safety Committee, which is a
standing committee of the Medical Executive Committee (MEC) reviews the
collective data. If an employee is unable to take part in a fire drill
he/she must complete the make-up evaluation in Appendix F.

**Audience, policy, and frequency:** All clinical employees of LP must
either attend one Fire Safety Training session or complete the make-up
evaluation on an annual basis. Specific plans for any persons with
disabilities are established in appropriate sections as needed. The
Safety Officer is responsible for notifying hearing impaired persons or
alarm situations. Evacuation routes are posted in each section. Clinical
employees of LP must attend one fire evacuation drill on an annual
basis. Specific plans for any persons with disabilities are established
in appropriate sections as needed. The Safety Officer is responsible for
notifying hearing impaired persons or alarm situations. The Safety
Officer will insure annual compliance for his/her section.

**RADIATION SAFETY ORIENTATION**

**Overview:** Employees may receive specimens contaminated with
radiation from patients receiving radionucleotide therapy and must
follow specific procedures related to these specimens. All employees
performing clinical services are required to attend a Radiation Safety
Orientation conducted by ORS assigned Health Physicist. The orientation
is designed to train clinical employees how to receive, transport, or
work with radioactive specimens. This training is targeted to those who
have never worked with radioactive material or who have some concerns.
The objectives of the training include: (1) working safely with samples
with low-level radioactive contamination, (2) understanding the risks of
exposure (3) following procedures for low-level radioactive samples, (4)
knowing when to call Radiation Safety Branch for assistance. Basic
safety and administrative actions include labeling of samples,
monitoring for contamination after working with the sample, using
universal precautions while handling the samples, and proper disposal
packaging for collection by the Radiation Safety Branch/NIH Waste
Contractor. A computer based training radiation orientation program is
under development and may be taken in place of the live training
session, as soon as it is available.

**Audience and Frequency:** Radiation Safety Orientation training must
be completed when hired, by all employees handling clinical specimens,
unless you have completed the regular Radiation Safety Training for
Authorized Users, or if you are exempted by your Section Chief.

**Policy:** Radiation Safety Orientation is now available as an online
computer based training.

Before taking the training class, you will have to register for an RSB
number. If you have already taken a radiation safety orientation class
and do not know your number, please contact John Jacobus, and he will
provide it to you. He may be reached via e-mail at jjacobus@mail.nih.gov
or call him at 6-5774.

If you do not yet have an RSB#, you may [register
online](http://www.nih.gov/od/ors/ds/rsb/register.html) or use the
[printable form](http://www.nih.gov/od/ors/ds/rsb/forms/nih88_22.pdf).
When completing the registration use Lance Liotta as the authorized
user, (Auth User \# 1496), and mark your work description as \"Patient
Care\" on the online form, or 03 under \"Type of User\" on the printable
form, which does not have Patient Care specifically listed. If
completing the online registration, do not select a class date, but just
submit the registration.

Once you receive your RSB#, you can complete the [online
training](http://www.nih.gov/od/ors/ds/rsb/training/index.html)

The Chair of the Safety Committee, will periodically receive and summary
of the training documentation and track who has completed it.

**LABORATORY SAFETY TRAINING COURSES**

(see <http://www.ors.od.nih.gov/labsafety/> for more information)

**Overview:** The following training courses are available:

-   Introduction to Laboratory Safety -- On Line Course

This is an introductory course on common exposure hazards and risks
found in research laboratories (chemical, radiation, biological). This
is a prerequisite for Laboratory Safety classroom.

-   Laboratory Safety at the NIH -- Classroom

This classroom course provides training on the recognition and control
of common physical, chemical and biological hazards found in NIH
research laboratories. The course provides required information on NIH
policies and procedures for working safely in the research laboratory as
well as methods for hazardous waste minimization. The course provides
information on engineering and personal protective equipment as well as
the NIH medical surveillance program available through the Division of
Safety, Occupational Medical Service. This course provides initial
training on the OSHA Hazard Communication Standard (29 CFR 1910.1200)
and Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR
1910.1450).

-   Working Safely with HIV and Bloodborne Pathogens

This course provides research personnel with information on working
safely with bloodborne pathogens in NIH research laboratories in
accordance with the OSHA Bloodborne Pathogen standard (29 CFR
1910.1030). This course specifically discusses work practices in
Biological Safety Level 2 and 3 laboratories, common methods of
bloodborne pathogen exposures and the use of various controls to help
prevent exposure. The course outlines steps to take in case of a
potential exposure and reviews medical pathological waste disposal
procedures. The course also reviews the Division of Safety, Occupational
Medical Service medical surveillance program including the hepatitis B
vaccination program.

-   Bloodborne Pathogen Refresher Training -- Online Course

This is a web based refresher course.

-   Laboratory Safety Refresher Course

This is a classroom refresher course.

**SHIPPING DIAGNOSTIC SPECIMENS OR HAZARDOUS GOODS**

**Overview, Audience & Policy:** Any individual that packs diagnostic
specimens for shipping must review this safety manual, including the
directions above and complete the Shipping Diagnostic Specimens Training
Evaluation, in Appendix L. This must be completed by all new employees
before they ship specimens and repeated on an annual basis to document
training and competence of the regulatory requirements pertaining to
shipping diagnostic specimens.

At lease one person must be trained for handling dangerous goods, by an
approved training program, in the event that we must send dangerous
goods, other than diagnostic specimens.

**Frequency:** This class may be taken at time of hire, before the
employee packs or ships diagnostic specimens. This training must be
repeated every two years. Additional training for clinical employees for
hazardous goods can be accomplished by attending approved training
courses.

**Instructions for enrolling in class:** Please contact your supervisor
or the Clinical Laboratory Manager if someone in your area needs
additional hazardous goods training

**REFERENCES**

-   [CC Isolations Guidelines
    ("flipchart")](http://www.cc.nih.gov/hes/CC/flipchrt/flipchrt.html)

-   [CC Universal Precautions Web
    site](http://intranet.cc.nih.gov/hospitalepidemiology/training/universalprecautions.shtml)

-   [Clinical Center Safety
    Committee](http://intranet.cc.nih.gov/ccc/safety/index.html)

-   [Clinical Center Emergency Management
    Plan](http://intranet.cc.nih.gov/od/emergencyplan/)

-   [CPR Study Guide for NIH Health Care
    Providers](http://www.nih.gov/od/ors/ds/oms/cprstudy.htm)