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SMILE

Johns Hopkins University


Baltimore, MD USA

General Lab Safety Policy - Guidelines


Author: Document Number: Fac10-13
Penny Stevens Effective (or Post) Date: 17 Feb 2009
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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General Lab Safety Policy - Guidelines


General Lab Safety Guideline Number Fac10-13-G
Effective Date 17 February 2009
Subject Page 1 of 2
General Laboratory Safety Guidelines Supersedes Fac10-13 v1.0
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

Audit:
Questions pertaining to Safety can be found in section Personnel Safety Section.

CAP Accreditation Checklist:


Laboratory Safety is addressed in CAP Laboratory General Checklist.

Background Information:
It is the laboratory policy to provide all employees with a safe work environment, which provides
as much protection as possible from exposure to human blood, body fluids, chemical, electrical
and biohazards and fire safety. It is our goal to ensure that all staff members are properly
trained to address every situation safely. These policies are designed for the protection of all
employees and will be enforced at all times.

Within the Laboratory, safety is practiced in three containment levels. The purpose of safety
containment is to reduce exposure of laboratory workers, other persons and the outside
environment to potentially hazardous agents. These include laboratory practices and
techniques, safety equipment, and facility design. The three levels used are:

1. Level I General Safety Precautions - This level of safety is basic for all laboratories in the
Department. General Safety is addressed in this SOP.

2. Level II Standard Precautions - This level of safety is added to the General Safety
Precautions when the task being performed exposes the worker to the risks of blood and
body fluids. See Appendix 1 of this SOP for additional information.

3. Level III Biosafety Level 3 - Laboratory management personnel will ensure that only
authorized persons who have been advised of the potential biohazard and who comply
with all entry and exit procedures enter laboratory areas. See Appendix 4 of this SOP for
additional information.

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Resources
1. Clinical Laboratory Standards Institute (CLSI). Clinical Laboratory Technical Procedure
Manuals; Fourth Edition. CLSI Document GP2-A4 (ISBN 1-56238-458-9). Clinical and
Laboratory Standards Institute, Wayne, PA
2. NCCLS. Clinical Laboratory Waste Management; Approved Guideline-Second Edition.
NCCLS document GP5-A2 (ISBN 1-56238-457-0). NCCLS, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898, USA 2002.
3. NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition. NCCLS
document GP17-A2 [ISBN 1-56238-530-5]. NCCLS, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2004.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved Guideline-Third Edition. CLSI document
M29-A3 [ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institue, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
5. College of American Pathologists (CAP) 2006. Commission on Laboratory
Accreditation, Laboratory Accreditation Program; Laboratory General Checklist Revised
9/27/2007.
6. CDC-NIH U.S. Department of Health and Human Services Primary Containment for
Biohazards: Selection, Installation and Use of Biological Safety Cabinets, Sept 2000,
2nd Edition.
7. ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit
Values. 1994-1995. Cincinnati, OH.
8. McKinney, Robert, Richard Jonathan. CDC/NHI Department of Health and Human
Services, Biosafety in Microbiological and Biomedical Laboratories 4th Ed. May 1999.
U.S. Government Printing Office. H.H.S. Publication No. (CDC) 93-8395.
9. Occupational exposure to hazardous chemicals in laboratories, OSHA laboratory
standards 29CFR1910.1450
10. Portable Fire Extinguishers, OSHA laboratory standards 29CFR 1910.157
11. Infection Control: The Johns Hopkins Hospital Interdisciplinary Clinical Practice Manual
(ICPM)
12. Infection Control Policy 1998, Osler 4,
13. The Johns Hopkins Institutions Office of Health, Safety and Environmental, Johns
Hopkins Safety Manual. 2001, 2024 E. Monument St. Telephone 955-5918
14. CDC-NIH U.S. Department of Health and Human Services Biosafety in Microbiological
and Biomedical Laboratories, May 1999, 4th Edition. (HHS Publication No. (CDC) 93-
8395).

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General Lab Safety - SOP


Document Effective
Penny S. Stevens
Author(s), Name &
Number Date
Title Sr. Int’l QA/QC Coordinator Fac10-13-SOP 17 Feb 2009
SMILE Comments: This document is provided as an example only. It must be revised to accurately
reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to
countercheck facts when considering their use in other applications. If you have any questions contact
SMILE.

Name, Title Signature Date

Approved
By

Name, Title Signature Date

SOP
Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
History
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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Purpose
This policy provides direction for the processes and procedures to ensure safe working
conditions for all laboratory personnel and to ensure laboratory practice and documentation are
performed in accordance with regulations.

Procedure
I. SCOPE - This procedure applies to all laboratory staff present in the laboratory.

II. RESPONSIBILITY & REVIEW SCHEDULE

A. Laboratory Supervisor and all laboratory staff must ensure that this SOP is
implemented and utilized as written.

B. Laboratory Technologist/Technician and Laboratory Supervisor are responsible


for reviewing, signing and dating all documents or reports generated for or during
the implementation and/or use of this SOP.

C. The Laboratory Director is responsible for approval, review and revision of this
SOP annually or as operational change warrants.

III. DEFINITIONS

A. AIDS – Acquired Immunodeficiency Virus


B. Amphyl – Commercial Disinfectant
C. CLSI - Clinical Laboratory Standards Institute
D. DAIDS - Division of AIDS
E. HBV – Hepatitis B Virus
F. HIV – Human Immunodeficiency Virus
G. Lysol – Commercial Disinfectant
H. MSDS - Material Safety Data Sheets
I. NCCLS – National Council of Clinical Laboratory Standards
J. OHS – Occupational Health Services
K. OSHA - Occupational Safety and Health Administration
L. PPE – Personal Protective Equipment
M. QA – Quality Assurance
N. Regulated Waste – infectious, biological, hazardous, chemical, radioactive &
sharps
O. Sharps – Waste that presents a physical hazard
P. SOP – Standard Operating Procedure
Q. Unregulated Waste – Other laboratory solid waste

IV. SAFETY PRECAUTIONS – Detailed in procedure.

V. EQUIPMENT, SUPPLIES & REAGENTS

A. Incinerator
B. Autoclave
C. Biohazard Containers
D. Red or Orange Biohazardous Storage Bags
E. Sharps Containers

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F. Unregulated Glass Disposal Containers


G. Universal Biohazardous Symbol labels
H. 10% Bleach Solution
I. Lab Coat
J. Goggles
K. Gloves

VI. QUALITY CONTROL – Not applicable

VII. GENERAL SAFETY PROCEDURE

A. Emergency Telephone Numbers

Location Phone Number Location Phone Number


Clinical Engineering Infection Control
Disaster Control Poison Control
Environmental Occupational Health
Services
Emergency Room Security

B. Personnel

1. Safety in the laboratory requires every employee's participation and


cooperation. Noncompliance with safety precautions not only endangers
the individual, but also compromises the health and safety of fellow
workers. Appropriate measures shall be taken to ensure the safety of
personnel working with hazardous materials.

2. Each employee is responsible for compliance with hand washing, dress


code & PPE guidelines:

• Hand Washing: Frequent hand washing is the most important single


precaution. Wash hands with soap and water after completing a task,
after removing gloves and immediately upon accidental contact with
contaminated materials. Protective hand cream may be applied in the
laboratory in the designated hand washing area.

• Long sleeved laboratory coat (buttoned closed) or a back closed gown


is required when working with patient specimens.

• Laboratory worker’s clothing must be clean, neat and in good repair.


The clothing should provide protection to the skin in the event of a
chemical splash or spill. Loose (e.g. saris, dangling neckties, and over
large or ragged laboratory coats), skimpy (e.g. shorts, strapless,
cropped or halter tops) or torn clothing are not permitted. Short
trousers or mini skirts are not permitted due to potential exposure
when the laboratory coat is open.

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• Personal Protective Equipment (PPE) such as fluid resistant gowns,


gloves, goggles, face masks, face shields are available and are
required when there is significant probability that potentially
hazardous substances may be splashed on the worker. Standard
precautions for laboratory workers must be followed as indicated in
Appendix 1.

• Shoes must be made of fluid impermeable material, leather or


synthetic, and cover the entire foot. Shoes with open toes are not
permitted. Cloth shoes are not recommended as they can absorb
chemicals or infectious fluids.

C. Personnel health

1. Each laboratory worker is responsible for his/her own safety and the
safety of his/her fellow workers

2. New hires are tested for hepatitis, rubella, rubeola and varicella-zoster by
the Occupational Health Clinic (OHS). All laboratory personnel are offered
appropriate immunizations or tests for agents handled in laboratory (e.g.,
TB skin test, Hepatitis B vaccine). OHS will counsel employees on the
advisability of immunizations, if needed. Tuberculosis and vision
screening are also performed. See appendix 1 for additional information

3. First Aid – Eye

• Propelled object injuries: Report to the Eye Clinic. Self-help is


discouraged.

• Chemical or other foreign material injuries: Get to an eyewash station


and irrigate the eye continuously with plain water and report to the
Eye Clinic. Do not use irrigation substitutes as they may cause
greater damage than no irrigation at all.

4. First Aid - Other

• Skin puncture or surface contamination: wash the skin site with soap
and water and bandage the site.

• Contaminated mucosal and conjunctival sites: wash with copious


amounts of water.

• Complete an incident report for all injuries regardless of severity. See


appendix 2.1 for details.

5. Employees showing signs or symptoms of contagious or infectious


diseases or that have been exposed to infectious diseases must be
referred to OHS for diagnosis and recommendation or appropriate
therapy. OHS is located at [location].

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6. Refer to appendix 2, Laboratory Accident Procedures, for additional


information.

D. Laboratory Precautions

1. Employees must use the laboratory laundry to clean soiled lab coats. Lab
coats are not to be laundered at home.

2. Food and beverages must not be stored in refrigerators, freezers, or other


areas where biological materials are present. Each laboratory area will
designate those places where food and beverages may be stored, and
identify them with appropriate signs

3. Eating, drinking, chewing gum, cosmetic application and contact lens


handling are not permitted in laboratories where biological materials are
handled and work is performed. Each laboratory shall designate areas
where eating and drinking are permitted.

4. Long hair must be tied back when working near open flames or
mechanical equipment, where there is a possibility of entanglement and
when working with patients and patient specimens.

5. Always use protective equipment that is provided for working with


hazardous materials. Be familiar with the location and operation of eye
washers, the location of fire extinguishers and other safety equipment.

6. No mouth pipetting. Mouth pipetting is prohibited. Use mechanical


pipetting devices.

7. Biosafety Level 3 Laboratories: Entry and exit procedures will be posted.


Laboratory personnel, maintenance personnel and all other visitors must
comply with all entry and exit procedures.

8. Laboratory personnel will assure that only visitors or maintenance


personnel who have been advised of the potential biohazards and have
been warned to avoid touching any working surfaces will be allowed
through the laboratory.

9. Smoking is not permitted within the laboratory. Smoke only in designated


smoking areas outside of the hospital.

E. Safe Handling of Needles - Most needle sticks can be prevented by "safety


awareness" on the part of the user. Use only approved containers as directed by
the manufacturer and exercise caution during handling.

1. Needles containing safety devices, when available, are always to be


applied after use when (e.g., butterfly, protective needles and syringes).

2. Needles and other sharps are never to be discarded directly into the
trash.

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3. Needles and other sharps must not be unattended (e.g., on furniture,


trays, equipment or in beds and linen).

4. Needles are not to be clipped or bent. Destruclips and similar devices are
not to be used.

5. Needles are never to be recapped by hand.

6. Employees must never reach into any container used for disposal of
contaminated sharps. If it is necessary to open a container, call [Health
Safety and Environment] at [number].

F. Waste Management

1. Laboratory management is responsible for proper management (handling,


storage, and disposal) of the waste generated in the lab.

2. Employees must comply with established policies and procedures.

3. Bench technologists are responsible for segregating and labeling all


waste that requires handling at the point of waste generation.

4. Employees must bring to management’s attention any unsafe working


conditions and identify opportunities for waste reduction.

5. All laboratory produced waste will be handled and discarded in


accordance with laboratory requirements, which includes proper
segregation, to ensure personnel safety.

6. Laboratory staff is encouraged to reduce waste generation and pollution


while still maintaining safety in accordance with accreditation and
regulatory requirements.

7. Transport and Storage will be conducted in accordance with accreditation


and local regulatory requirements.

8. See appendix 7 for additional information.

G. Biological Material Transfer

1. All pipetting shall be done with mechanical assistance (e.g. bulbs, semi-
automated pipette) to avoid dangers from liquids or aerosols. Never
pipette by mouth.

2. Care shall be taken when opening specimen containers to reduce aerosol


formation. Barrier protection is to be used when opening of evacuated
blood collection tubes after centrifugation as it may result in a spray of
fine droplets of serum or plasma. Vacuum tube containers should be
opened by twisting the rubber stopper while pulling it.

3. If splashing is possible, perform the task in a Biological Safety Cabinet.

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H. Reusable Item Sterilization

1. All reusable items of metal, glass, or heat-resistant plastic will be


sterilized by steam heat in autoclave.

2. Non-heat-resistant items can be decontaminated by soaking in an iodine


solution or 1:10 V/V dilution of bleach for a minimum of six hours when
viral agents are suspected.

I. Disinfecting Work Surfaces

1. There is no single disinfectant that can be used in the laboratory at a


single concentration to cover all possible contingencies. The
concentration of the agent spilled and the amount of organic material
(blood, body fluids and other matter) can interfere with disinfectant activity
and should be considered when determining disinfectant procedures.
The time allowed for contact with the disinfectant will also vary according
to the material in question.

2. All work surfaces used daily, such as bench tops, sinks, and mobile carts,
etc., must be disinfected at the end of each work shift. Use 1:10 v/v
solution of Household Bleach or other approved cleaner for disinfecting
work surfaces. For other biohazard spills, use any management approved
product, such as Lysol or Amphyl.

3. Decontamination of body fluid spills and grossly contaminated surfaces


shall occur as soon as possible using the following procedures:

• Notify all personnel in the immediate work area.

• Put on gloves and any other necessary PPE.

• Contain large spills by surrounding with paper towels or other


absorbent material.

• Saturate the contaminated area with a 1:10 v/v solution of sodium


hypochlorite (household bleach), 70% ethanol or isopropyl alcohol or
other approved disinfectant.

• Cover the spill with paper towels or other absorbent material.

• Allow the disinfectant to penetrate for a minimum of 10 minutes


making certain the area is well-marked.

• If broken glass or other sharp material is present, it must never be


picked by up hand. Forceps, tongs, disposable bio scoop or dustpan
and broom must be used.

• Discard the contaminated materials in an appropriate medical waste


container (sharps container, biohazard box or autoclave bucket)
depending on the nature of the biohazardous material.
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• Perform a final wipe with the disinfectant and let dry.

J. Centrifugation - The following precautions serve to minimize the danger from


aerosolization of infective material:

1. All specimens will be centrifuged in a closed system.

2. Centrifuges with safety-interlock features, which prevent opening the unit


when it is in motion, are recommended.

3. Centrifuges used for processing potentially infective biological materials


shall be disinfected weekly with 1:10 V/V dilution of sodium hypochlorite
(household bleach).

K. Flammable/Combustible Liquids

1. Quantities of flammable or combustible liquids used or stored outside of


an approved storage cabinet shall not exceed the needs of five working
days.

2. All flammable or combustible liquid containers, 1 gallon or larger, shall be


stored in approved flammable or combustible liquid storage cabinets or in
approved storage rooms.

3. The total capacity of all approved flammable or combustible liquid storage


cabinets in any one laboratory, up to 5000 square feet, shall not exceed
60 gallons (227.1 L).

4. The storage of any quantity of flammable or combustible liquid in a


domestic refrigerator is prohibited. Only a refrigerator specifically
designated as an approved Flammable Materials Storage Refrigerator or
domestic refrigerators modified to remove all sparking devices from the
storage compartment, are approved for storage of flammable or
combustible liquids.

5. See Appendix 6 for additional information.

L. Compressed Gas Cylinders

1. All compressed gas cylinders, either in use or in storage, shall be secured


in an upright position by means of a strap or chain.

2. All cylinders, lines and equipment used with flammable compressed


gases shall be grounded and stored separate from oxidizing gases such
as oxygen.

3. Suitable hand trucks will be utilized when transporting gas cylinders.

4. See Appendix 5 for additional information.

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M. Chemical Hazards – The “Right to Know” Law

1. All laboratories are required by Occupational Safety and Health


Administration (OSHA) to:

• Have Material Safety Data Sheets (MSDS) readily accessible to all


employees for chemicals used in the lab.

• Label containers of chemicals properly; manufacturer’s labels are


acceptable.

• Train employees to recognize potential hazards in the workplace and


proper procedures for handling hazardous substances.

• Prepare a list of hazardous chemicals used in laboratory. Review and


update this list annually.

2. See Appendix 6 for additional information.

N. Radioisotopes - Radioisotopes pose a significant health hazard to employees.


If any radioisotopes are to be introduced into the laboratory, the Laboratory
Supervisor, Manager & Medical Director must be notified. Prior to introduction
into the laboratory, staff must undergo safety training to include health hazard
notification, handling, containment & emergency procedures. Management will
notify DAIDS via email prior to the introduction and develop a procedure that
includes the following: safe handling, emergency, documentation requirements,
designated work storage, waste and storage areas, methods for contamination
inspections, authorized users, portable or semi-portable monitoring devices and
product, work & waste area labeling requirements.

O. Carcinogens - Specific regulations have been established by OSHA regarding


the handling of carcinogens. An inventory of all such materials must be
maintained and specific protective measures must be observed. See Appendix 6
additional information.

P. Safety Reporting

1. Employees are required to report all hazardous conditions to the


supervisor or technologist in charge, especially the following:

• Improperly disposed sharps.


• Improperly stored containers of flammable liquids.
• Improperly anchored gas cylinders.
• Frayed or damaged electrical wiring and damaged plugs.
• Unused gas cylinders with open valves or empty cylinders without
safety caps.
• Missing emergency equipment of any type.
• Improperly labeled or unlabelled reagent containers.
• Obstruction in aisles or fire exits.
• Fire extinguishers with low charge.

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• Propped open fire doors that are not equipped with automatic fire door
closures.
• Spills involving any hazardous materials.
• Electrical shocks experienced while working with instruments.

2. Reports may be submitted verbally or in writing, without fear of


repercussion. Management will fully investigate all reports, to include
anonymous reports. Laboratory personnel will be made aware of the
mechanism for anonymous reporting.

3. Employees will be advised of all safety report findings at monthly


laboratory meetings. The reporting employee’s identity will be held in
confidence, unless the employee requests disclosure.

Q. Training and education

1. All new employees will be trained in safety precautions: Standard precautions,


fire safety, flammable liquids, compressed gas cylinders, hazardous waste
disposal, potential hazards of Hepatitis B & C and HIV, carcinogens, chemical
hygiene and emergency equipment.

2. This training program must be documented and updated as needed or on a


yearly basis.

3. The training program will ensure that all workers know:

• Fire Emergency Plans- How to report a fire, when to pull the alarm and phone
numbers to call, location of the best fire exit routes, exit signs and evacuation
routes, the hospital fire alarm system, the number to call and how to operate
a fire extinguisher

• Electrical & Mechanical Safety - Instrument grounding requirements, what to


do if shocks are felt & UV light precautions

• Flammable Liquid Policy – Use, storage and maximum amounts that can be
stored in the laboratory

• Compressed Gas - How to open/close valves, secure and move tanks, use of
chains, strap and non-tip base containers.

• Decontamination - How to decontaminate infectious waste before disposal,


autoclave, incineration, the types of containers for disposal including sharps,
red bags, glass and general trash and hospital approved disinfectants

• Chemical Safety – MSDS location and use, explanation of the biohazard


symbol, color codes and precautions, where chemicals & carcinogens are
used and stored; warning labels, decontamination and disposal procedures

• Personal Safety - Potential hazards, modes of transmission & prevention for


blood borne pathogens, personal protective equipment use, storage,

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decontamination, disposal and limitations, corrective actions when confronted


with spills or personal exposure to fluids or tissue.

• Emergency Equipment - How to operate emergency equipment (eyewash,


shower, fire blanket, etc.) and the maintenance required.

4. Documentation of initial safety training will be found in the “New Employee


Orientation checklist”. This checklist must be reviewed and signed by the
employee and trainer within 14 days of employment.

5. Bloodborne Pathogen & fire safety training for all laboratory staff must be
renewed annually.

6. Documentation of initial and annual safety training will be maintained in the


employee’s training folder.

Procedural Notes and Limitations – Not applicable

Appendices:

Appendix Content
1 Standard Precautions
2 Laboratory Accident Procedures
2.1 Incident Report Form
3 Fire Safety Plan
3.1 Fire Investigation Response Evaluation (FIRE) Form
4 Principles of Biosafety
5 Electrical and Mechanical Safety
5.1 Emergency Equipment Maintenance Log
6 Chemical Hazards
7 Waste Management

References:
1. Clinical Laboratory Standards Institute (CLSI). Clinical Laboratory Technical Procedure
Manuals; Fourth Edition. CLSI Document GP2-A4 (ISBN 1-56238-458-9). Clinical and
Laboratory Standards Institute, Wayne, PA
2. NCCLS. Clinical Laboratory Waste Management; Approved Guideline-Second Edition.
NCCLS document GP5-A2 (ISBN 1-56238-457-0). NCCLS, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898, USA 2002.
3. NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition. NCCLS
document GP17-A2 [ISBN 1-56238-530-5]. NCCLS, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2004.

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4. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from


Occupationally Acquired Infections; Approved Guideline-Third Edition. CLSI document
M29-A3 [ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institue, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
5. College of American Pathologists (CAP) 2006. Commission on Laboratory
Accreditation, Laboratory Accreditation Program; Laboratory General Checklist Revised
9/27/2007.
6. CDC-NIH U.S. Department of Health and Human Services Primary Containment for
Biohazards: Selection, Installation and Use of Biological Safety Cabinets, Sept 2000,
2nd Edition.
7. ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit
Values. 1994-1995. Cincinnati, OH.
8. McKinney, Robert, Richard Jonathan. CDC/NHI Department of Health and Human
Services, Biosafety in Microbiological and Biomedical Laboratories 4th Ed. May 1999.
U.S. Government Printing Office. H.H.S. Publication No. (CDC) 93-8395.
9. Occupational exposure to hazardous chemicals in laboratories, OSHA laboratory
standards 29CFR1910.1450
10. Portable Fire Extinguishers, OSHA laboratory standards 29CFR 1910.157
11. Infection Control: The Johns Hopkins Hospital Interdisciplinary Clinical Practice Manual
(ICPM)
12. Infection Control Policy 1998, Osler 4,
13. The Johns Hopkins Institutions Office of Health, Safety and Environmental, Johns
Hopkins Safety Manual. 2001, 2024 E. Monument St. Telephone 955-5918
14. CDC-NIH U.S. Department of Health and Human Services Biosafety in Microbiological
and Biomedical Laboratories, May 1999, 4th Edition. (HHS Publication No. (CDC) 93-
8395).

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Appendix 1 - Standard Precautions SOP

Author: Document Number: Fac10-13 App1


Penny Stevens Effective (or Post) Date: 17 Feb 2009
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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Appendix 1 - Standard Precautions SOP


Document Effective
Penny S. Stevens
Author(s), Name &
Number Date
Title Fac10-13-SOP 17 Feb 2009
Sr. Int’l QA/QC Coordinator
Appendix 1
SMILE Comments: This document is provided as an example only. It must be revised to accurately
reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to
countercheck facts when considering their use in other applications. If you have any questions contact
SMILE.

Name, Title Signature Date

Approved Jo Shim MBA, MT(ASCP)


By

Name, Title Signature Date

SOP
Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
History
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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APPENDIX 1 - STANDARD PRECAUTIONS

I. DEFINITIONS

1. AIDS - Acquired Immunodeficiency Syndrome, caused by HIV


2. HBV - Hepatitis B Virus
3. HCV - Hepatitis C Virus
4. HIV - Human Immunodeficiency Virus
5. PPE - Personal Protective Equipment, which includes but is not limited to gloves,
aprons, eye protection, etc.

II. TABLE OF CONTENTS

1. Nature of the risks


2. Standard Precautions Principle
3. Exposure categories
4. Standard precautions barrier protection
5. Medical Examination
6. Hepatitis B Vaccination

III. NATURE OF THE RISKS

1. HEPATITIS: Most cases of laboratory associated hepatitis are caused by


Hepatitis B (HBV) or Hepatitis C (HCV) viruses, which account for most of the
transfusion-associated Hepatitis cases seen in the USA. Laboratory acquired
Hepatitis is now recognized as a major occupational hazard to laboratory workers
handling biological materials.

The risk of HBV infection is primarily related to the degree of contact with blood
in the work place and also to the hepatitis B e antigen (HBeAg) status of the
source person. In studies of health care workers who sustained injuries from
needles contaminated with blood containing HBV, the risk of developing clinical
hepatitis if the blood was both hepatitis B surface antigen (HBsAg)- and HBeAg-
positive was 22%--31%; the risk of developing serologic evidence of HBV
infection was 37%--62%. By comparison, the risk of developing clinical hepatitis
from a needle contaminated with HBsAg-positive, HBeAg-negative blood was
1%--6%, and the risk of developing serologic evidence of HBV infection, 23%--
37%. In serologic studies conducted in the United States during the 1970s,
health care workers had a prevalence of HBV infection approximately 10 times
higher than the general population.

The average incidence of anti-HCV seroconversion after accidental


percutaneous exposure from an HCV-positive source is 1.8% (range: 0%--7%).
Transmission rarely occurs from mucous membrane exposures to blood, and no
health care worker transmission has been documented from intact or nonintact
skin exposures to blood. Data are limited on survival of HCV in the environment.
In contrast to HBV, the epidemiologic data for HCV suggest that environmental
contamination with blood containing HCV is not a significant risk for transmission
in the health-care setting, with the possible exception of settings where HCV
transmission related to environmental contamination and poor infection-control
practices have been implicated. The risk for transmission from exposure to fluids

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or tissues other than HCV-infected blood also has not been quantified but is
expected to be low.

2. AIDS: The etiology of Acquired Immunodeficiency Syndrome (AIDS) is a


retrovirus called Human Immunodeficiency Virus (HIV). Transmission occurs
from infected persons through direct intimate contact involving mucosal surfaces,
such as sexual contact, or through parenteral spread, such as shared needles
and syringes. Airborne transmission and spread through casual contact has not
been documented.

In prospective studies of health care workers, the average risk of HIV


transmission after a percutaneous exposure to HIV-infected blood has been
estimated to be approximately 0.3% and after a mucous membrane exposure,
approximately 0.09%. Although episodes of HIV transmission after nonintact skin
exposure have been documented, the average risk for transmission by this route
has not been precisely quantified but is estimated to be less than the risk for
mucous membrane exposures. The risk for transmission after exposure to fluids
or tissues other than HIV-infected blood also has not been quantified but is
probably considerably lower than for blood exposures.

IV. STANDARD PRECAUTIONS PRINCIPLE

Standard Precautions expands the coverage of Universal Precautions by recognizing that any
body fluid may contain contagious microorganisms. Since medical history and examination
cannot reliably identify all patients with blood-borne pathogens, all body fluids are treated as if
known to be infectious for HIV, HBV, HCV, and other blood borne pathogens. Standard
Precautions are designed to reduce the risk of transmission of microorganisms from both
recognized and unrecognized sources of infection in the hospital. Standard precautions apply to
blood and body fluids, secretions, excretions and all tissues.

V. EXPOSURE CATEGORIES

1. Category I: Tasks that involve exposure to blood, body fluids, or tissues. All
procedures or other job-related tasks that involve an inherent potential for
mucous membrane or skin contact with blood, body fluids, or tissues, or a
potential for spills or splashes of them, are Category I tasks. Use of appropriate
protective measures should be required for every employee engaged in Category
I tasks.

2. Category II: Tasks that involve no exposure to blood, body fluids, or tissues, but
employment may require performing unplanned Category I tasks. The normal
work routine involves no exposure to blood, body fluids, or tissues, but exposure
or potential exposure may be required as a condition of employment.
Appropriate protective measures should be readily available to every employee
engaged in Category II tasks.

3. Category III: Tasks that involve no exposure to blood, body fluids, or tissue (and
category I tasks that are not a condition of employment). The normal work routine
involves no exposure to blood, body fluids, or tissues. Persons who perform
these duties are not called upon as part of their employment to perform or assist
in emergency medical care or first aid or to be potentially exposed in some other

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way.

4. Laboratory central administration and data processing personnel , are considered


Category III, other laboratory workers can fall into all three categories. For this
reason "tasks" can be identified into two categories.

• Tasks with no exposure to blood, blood products, body fluids, or tissue. The
Department’s “General Safety Requirements” will be used.

• Tasks with category I exposure. Standard precautions will be used.

VI. BARRIER PROTECTION - Each employee is responsible for compliance with all
policies and procedures as stated in the General Laboratory Safety Policy in addition to
the following:

1. Properly fitting gloves will be worn when:

• Handling blood, tissues, body fluids or items contaminated with blood or body
fluids including specimen containers, laboratory instruments, counter tops,
etc.

• Performing venipuncture, changing gloves and washing hands between each


patient.

• Worker's hands are abraded or active dermatitis is present.

2. Gloves will be replaced immediately when torn, contaminated, and before


touching non-contaminated items or surfaces.

3. Always wash hands with soap and water, for at least 10 seconds or use an
alcohol based hand rub solution after glove removal.

4. Masks, eye protection, face shields, splashguards or safety cabinets must be


used if splashing or spraying of blood or body fluid is anticipated.

5. All lab coats, gloves, and other personal protective equipment must be removed
prior to leaving the work area.

6. Soiled gloves, masks and other disposable personal protective equipment will not
be washed or disinfected for reuse and will be discarded into red bag-lined
receptacles or autoclave buckets after use.

7. Open-toe footwear does not provide adequate protection and are not permitted in
the laboratory.

8. Plastic or disposable aprons

• Aprons are available for further protection over lab coats if there is potential
for splashing or spraying of blood or body fluids.

• Disposable aprons will be discarded immediately when torn or contaminated.


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Use the laboratory laundry to clean soiled non-disposable or plastic aprons.


Aprons are not to be laundered at home.

• Aprons are not to be used as a sole source for protection.

VII. MEDICAL EXAMINATION

1. Occupational Health Services will determine the immune status of new


employees for Hepatitis B, Rubeola, Varicella Zoster, and Rubella and
appropriate vaccinations will be offered.

2. Semiannual tuberculin tests are administered to all Microbiology personnel.


Annual tuberculin tests are administered to all other departmental personnel. If a
tuberculin test becomes positive, a routine chest x-ray will be performed.

VIII. HEPATITIS B VACCINATION

All laboratory employees will be offered the Hepatitis B vaccine series by the Occupational
Health Services. Employees who decline the vaccine must complete a declination form, which
will be kept on file in the Occupational Health Services office. If an employee declines the
vaccine, he/she may still opt to receive the vaccine in the future at no cost.
IX. EDUCATION

All laboratory employees reasonably expected to have direct contact with body fluids will receive
initial and annual education on the following:

1. Precautionary measures
2. Proper care and use of PPE
3. Epidemiology, modes of transmission and prevention of HIV, HCV, and HBV
4. Application of standard precautions to their work practices.

X. REFERENCES

1. Clinical Laboratory Standards Institute (CLSI). Clinical Laboratory Technical Procedure


Manuals; Fourth Edition. CLSI Document GP2-A4 (ISBN 1-56238-458-9). Clinical and
Laboratory Standards Institute, Wayne, PA
2. NCCLS. Clinical Laboratory Waste Management; Approved Guideline-Second Edition.
NCCLS document GP5-A2 (ISBN 1-56238-457-0). NCCLS, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898, USA 2002.
3. NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition. NCCLS
document GP17-A2 [ISBN 1-56238-530-5]. NCCLS, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2004.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved Guideline-Third Edition. CLSI document
M29-A3 [ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institue, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.

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5. College of American Pathologists (CAP) 2006. Commission on Laboratory


Accreditation, Laboratory Accreditation Program; Laboratory General Checklist Revised
9/27/2007.
6. CDC-NIH U.S. Department of Health and Human Services Primary Containment for
Biohazards: Selection, Installation and Use of Biological Safety Cabinets, Sept 2000,
2nd Edition.
7. ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit
Values. 1994-1995. Cincinnati, OH.
8. McKinney, Robert, Richard Jonathan. CDC/NHI Department of Health and Human
Services, Biosafety in Microbiological and Biomedical Laboratories 4th Ed. May 1999.
U.S. Government Printing Office. H.H.S. Publication No. (CDC) 93-8395.
9. Occupational exposure to hazardous chemicals in laboratories, OSHA laboratory
standards 29CFR1910.1450
10. Portable Fire Extinguishers, OSHA laboratory standards 29CFR 1910.157
11. Infection Control: The Johns Hopkins Hospital Interdisciplinary Clinical Practice Manual
(ICPM)
12. Infection Control Policy 1998, Osler 4,
13. The Johns Hopkins Institutions Office of Health, Safety and Environmental, Johns
Hopkins Safety Manual. 2001, 2024 E. Monument St. Telephone 955-5918
14. CDC-NIH U.S. Department of Health and Human Services Biosafety in Microbiological
and Biomedical Laboratories, May 1999, 4th Edition. (HHS Publication No. (CDC) 93-
8395).
15. CDC. Update: U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to HBV, HCV, and HIV and Recommendations for
Postexposure Prophylaxis. MMWR 2001; 50(No. RR-11):1-42.

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Appendix 2 – Laboratory Accident SOP

Author: Document Number: Fac10-13 App 2


Penny Stevens Effective (or Post) Date: 17-Feb-09
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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Appendix 2 – Laboratory Accident SOP

Penny S. Stevens MBS, MT (ASCP), Document Number Effective Date


Author(s), Name & CLS (NCA)
Title
Fac10-13-SOP 17 Feb 2009
International QA/QC Coordinator
Appendix 2
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when
considering their use in other applications. If you have any questions contact SMILE.

Name, Title Signature Date


Approved By
Jo Shim MBA, MT(ASCP)

Name, Title Signature Date

SOP Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
History 2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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APPENDIX 2
LABORATORY ACCIDENT PROCEDURES

I. DEFINITIONS

OHC – Occupational Health Clinic


ER – Emergency Room

II. TABLE OF CONTENTS

1. Occupational Health Clinic


2. Personnel Injuries
3. Exposure to Blood
4. Other Injuries
5. Patient/Blood Donor/Visitor Injuries
6. Safety Incident Investigation Form, Appendix 2.1

III. OCCUPATIONAL HEALTH CLINIC – [PHONE NUMBER]

The Occupational Health Clinic (OHC) is located at [location]. It is equipped and staffed to provide screening and
treatment services as defined herein to employees with job-related injuries and illnesses. The OHC will provide
treatment to employees for work related injuries and illnesses from 7:30 AM to 5:00 PM- Monday through Friday,
except days observed as Holidays. If the OHC is closed the employee should report to the Emergency
Department. This applies to all employees of the [your hospital/lab].

IV. PERSONNEL INJURIES

1. All accidents resulting in personnel injuries, no matter how minor, are to be reported and
documented via the Safety Investigation Form, appendix 2.1. The report is completed and signed
by the Supervisor. One copy is to be taken to the OHC or Emergency Department when the clinic
is closed. The original must be submitted to the Laboratory Director or designee for further
investigation.

2. All employees with job related injuries will report to the OHC during time and days specified
above. The employee will be taken directly to the Hospital Emergency Department or in cases of
serious emergencies call [number]. Have a co-worker call ER to inform them that the injured
individual is on the way.

3. Examples of serious emergencies are: seizures, loss of consciousness, life threatening injury
and/ or change in mental status.

4. When the OHC is closed, any employee with a job related injury must go to the Emergency
Department for initial emergency treatment of any injury. The employee and/or supervisor are
responsible for the completion of the Safety Investigation Form, appendix 2.1, within 24 hours.

5. All employees treated in the Emergency Department will be given a copy of Safety Investigation
Form and referred within 24 hours to OHC. (48 hours if injury occurs over a weekend.)

V. EXPOSURE TO BLOOD

1. If an employee is exposed to blood or other potentially infectious materials by way of a


needlestick, percutaneous injury, mucous membrane contact, or non-intact skin contact, the
following procedures should be initiated:

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• Notification: After a suspected exposure occurs, it is the employee's responsibility to contact
his/her supervisor, to initiate a Safety Investigation (appendix 2.1) and to immediately report
to the Emergency Room.

• Evaluation: After Emergency Room treatment, the exposure evaluation will be managed in
the OHC. The employee will receive free medical counseling about the risk of infection and
treatment options. Follow-up treatment, if needed, will be at no cost to the employee and will
be private and confidential.

• Source patient evaluation: If consent is provided, source patient blood will be tested for HIV,
HBV, and HCV.

• Follow-up Procedures: The Infectious Disease Physician will consider appropriate


prophylaxis for acute exposure to HIV, HBV, or HCV, based upon medical indications, the
serologic status, and the informed consent of the health care worker.

• Post-exposure Antiviral Therapy for HIV: The Infectious Disease Physician on-call will
provide counseling to the exposed employee regarding the use of antiviral agents for HIV
prophylaxis following an exposure.

• Post-exposure Immunotherapy for HBV: The Infectious Disease Physician on call will provide
counseling to the exposed employee regarding Hepatitis B virus (HBV) post-exposure
management.

2. Any immunotherapy indicated will be given to the employee by the Emergency Department triage
nurse by telephone order of the Infectious Disease Physician on call.

3. All treatment will be documented on the Safety Investigation Form (appendix 2.1) and will be
reviewed as indicated previously.

4. The OHC will provide follow-up with the patient to ensure compliance with treatment course and
follow-up medical examinations.

VI. OTHER INJURIES

1. Eye Injuries: If the injury is due to the splashing of infectious body fluids or chemical substances
administer first aid utilizing the eye wash stations as indicated in #3 below. Report immediately to
the Eye Clinic if available. Operating hours are [enter hours if applicable] - Monday through
Friday, except days observed as Holidays or [Enter days and times if applicable]. If the Eye
Clinic is closed the employee should report to the Emergency Department. Report to the OHC
on the next business day following treatment. Take the completed Safety Investigation Form
(appendix 2.1) from your supervisor for further disposition.

2. Minor injuries, such as glassware cuts, small burns from heat or chemical sources, bruises or
sprains from falls and etc., are to be reported immediately to the laboratory supervisor. The
employee, with a completed Safety Investigation Form, will report to the OHC.

3. Personnel suffering a major injury will be provided immediate emergency assistance or first aid
while a physician is being summoned. Such assistance might involve use of eye wash showers,
suppression of bleeding, treatment of shock and etc. Immediately summon medical assistance
from the Emergency Room at [number]. When the injured individual is stabilized to the point
that he/she can be moved, the employee should be taken to the Emergency Room by stretcher
or wheelchair for further treatment.

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VII. PATIENT/BLOOD DONOR/VISITOR INJURIES

Incident involving patients, blood donors and visitors are to be reported and documented via the Safety
Investigation Form. The individual is to be sent to the Emergency Room for care and must be accompanied by a
Laboratory staff member. The Safety Investigation Form must be sent to the Emergency Room as soon as
possible following the incident. The completed form with the physician's notes is to be brought back to the
laboratory by the staff member. The completed original form is to be forwarded to Quality Management Team for
further investigation and/or follow-up.

VIII. SAFETY INCIDENT REVIEWS

All safety incidents must be reported to the Laboratory Director within 24 hours of the occurrence. The Safety
Incident report must be submitted to the Quality Management Team within 72 hours, regardless of the completion
status. The Quality Management Team and the Laboratory Director will convene a safety meeting to review all
safety incidents within 24 hours of notification to determine if immediate action and preventive measures are
required. Investigation findings will be incorporated into the laboratory’s quality management program to avoid
recurrence.

IX. REFERENCES

1. Clinical Laboratory Standards Institute (CLSI). Clinical Laboratory Technical Procedure Manuals; Fourth
Edition. CLSI Document GP2-A4 (ISBN 1-56238-458-9). Clinical and Laboratory Standards Institute,
Wayne, PA
2. NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition. NCCLS document GP17-A2
[ISBN 1-56238-530-5]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2004.
3. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline-Third Edition. CLSI document M29-A3 [ISBN 1-56238-567-4].
Clinical and Laboratory Standards Institue, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2005.
4. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory
Accreditation Program; Laboratory General Checklist Revised 9/27/2007.
5. Infection Control: The Johns Hopkins Hospital Interdisciplinary Clinical Practice Manual (ICPM)
6. Infection Control Policy 1998, Osler 4,
7. The Johns Hopkins Institutions Office of Health, Safety and Environmental, Johns Hopkins Safety
Manual. 2001, 2024 E. Monument St. Telephone 955-5918
8. CDC-NIH U.S. Department of Health and Human Services Biosafety in Microbiological and Biomedical
th
Laboratories, May 1999, 4 Edition. (HHS Publication No. (CDC) 93-8395).
9. CDC. Update: U.S. Public Health Service Guidelines for the Management of Occupational Exposures to
HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR 2001; 50(No. RR-
11):1-42.

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APPENDIX 2.1
Laboratory Safety Incident Investigation
Purpose: To document a safety incident and identify opportunities for improvement.

Instructions:

1. Try to investigate as soon as possible to understand why certain decisions were made.
2. Have a multidisciplinary group of people (e.g., nurse, physician, administrator, etc.) present for discussion, if
possible. Encourage participants to use blameless feedback and observations to support improvement.
3. Discussion can be brief: 10-15 minutes. Appoint a person to document the incident below.
4. Share key elements of learning within the Quality Assurance Team and staff to identify opportunities for
improvement.

Type of Safety Event:

Risk event, explain: ______________________________________________________________


Operational defect, explain: _______________________________________________________
Other safety defect, explain: _______________________________________________________

1. What happened?

2. System Factors

A. Employee Factors

Was the employee fatigued, ill or agitated?


Was there a language barrier?
Were there personal or social issues?
Other:

Not applicable
Comments:

B. Task Factors

Was there a procedure available to guide the action?


Was the procedure current, approved and applicable to the task performed?
Were the steps clear, accurate and easy to follow?
Other:

Not applicable
Comments:

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C. Training and Education Factors

Was the employee knowledgeable, skilled & competent in the task performed?
Did the employee follow the procedure as written?
Did the employee seek supervision or help?
Other:

Comments:

D. Information Technology/CPOE Factors

Did the safety event involve computer/software utilization?


Did the computer/software malfunction?
Did the user check what he/she entered to make sure it was correct?
Not applicable
Comments:

Local Environment

Was there adequate equipment available and was the equipment working properly?
Was there adequate operational (administrative and managerial) support?
Was the physical environment conducive to the task performed?
Was staffing sufficient to provide uninterrupted task performance?
Were there distractions present? (trainees, phone interruption, etc.)
Did workload impact the provision of good care?
Other:

Comments:

Institutional Environment

Were adequate financial resources available? (reagents, equipment or supplies used were not as requested due to budget constraints)
Was assistance staff adequately in-serviced/educated? (trainee providing assistance was unfamiliar with task)
Does the administration work with the departments regarding what and how to support their needs?
Other:

Comments:

3. Why did it happen? Where did the system break-down to allow this event to occur? (Consider system
factors.)

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4. What will we do to reduce the probability of it happening again?

Action: __________________________________________________________

Point Person: _____________________________________________________

Follow up Date: ___________________________________________________

Action: __________________________________________________________

Point Person: _____________________________________________________

Follow up Date: ___________________________________________________

5. How will we know if these changes have worked?

6. How will we communicate the lessons learned from this investigation and any resulting changes in
processes?

Supervisor:

Name Title Signature Date

QA Team Review:

Name Title Signature Date

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Appendix 3 – Fire Safety SOP
Author: Document Number: Fac10-13 App 3
Jo Shim Effective (or Post) Date: 17-Feb-09
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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Appendix 3 – Fire Safety SOP

Jo Shim MBA, MT (ASCP) Document Number Effective Date


Author(s), Name &
Title Fac10-13-SOP 17 Feb 2009
International QA/QC Coordinator
Appendix 3
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when
considering their use in other applications. If you have any questions contact SMILE.

Name, Title Signature Date


Approved By

Name, Title Signature Date

SOP Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
History 2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

Fac10-13_App3_Fire_Safety .doc Version #: 2.0 Page 2 of 10


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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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APPENDIX 3
FIRE SAFETY

I. TABLE OF CONTENTS

1. Discovering a fire
2. Operation of the Fire Alarm System
3. What happens when an alarm is sounded?
4. All clear
5. Fire incident response evaluation
6. Evacuation plan
7. Training

II. DISCOVERING A FIRE

1. If you discover a fire, remain calm and report the fire immediately regardless of size. Follow the
procedure outlined in 2-10 below.

2. Clear the area of personnel. Take patients to designated refuge area. Direct others to evacuate
the building.

3. If fire alarms are available, pull the nearest fire alarm box.

4. Dial [number]. Tell the operator the building involved, the floor, the kind of fire, your name and
extension number.

5. If possible turn off gas, especially oxygen valves.

6. If possible, return flammable materials to approved storage cabinets.

7. Remove ventilation by closing the windows and doors.

8. If the fire is small and you have received fire extinguisher training, use the appropriate fire
extinguisher or other equipment to put the fire out.

9. Leave the building by the nearest accessible fire exit. Do not use elevators. Use stairs or exit
through a fire door to an adjacent building.

10. Learn the acronym SAVE – S-Save the patient/lemployee, A-Sound the Alarm, V- Ventilation
(close windows and doors), E- Extinguish. This will help you to remember what to do if you are
ever confronted by a fire.

III. OPERATION OF THE FIRE ALARM SYSTEM.

1. The proper procedure for transmitting a fire alarm, using three different types of fire alarms, is as
follows:

2. Round fire alarm box with glass door lock.

• Break glass strip on the face of the alarm box by striking breaker plate sharply with palm of
hand or fist. The door will swing open, allowing access to the operating lever. This does not
send out a signal, it only exposes the operating lever.

• Pull the operating lever all the way down and release. When the operating lever is pulled
down, it winds a clock spring mechanism inside the fire alarm box which provides the power
to turn a coded wheel. The turning wheel electrically transmits the four digit code sequence

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four times. The operating lever returns to its original position and the box is automatically
reset when the signal is completed.

3. Rectangular fire alarm - Pull down lever:

The operating lever is flush mounted on the face of the alarm box and is readily accessible.
When the operating lever is pulled down, the clock spring alarm mechanism is wound and
the reset signal is transmitted.

The operating lever returns to its original position and the box is automatically reset when the
signal is complete.

4. Rectangular fire alarm box -glass lock on operating arm:

The operating lever, which is flush mounted on the face of this alarm box, is secured by a glass
rod. To activate this alarm box, the operating lever must be pulled down with sufficient force
to break the glass rod. When the operating arm is pulled down, a switch is activated to
electrically turn the coded wheel and transmit the alarm signal.

The operating arm does not return to its original position, and the box does not reset
automatically.

IV. WHAT HAPPENS WHEN AN ALARM IS SOUNDED?

(Describe the procedure followed by your lab)

1. All fire alarms sounded in the Hospital are transmitted automatically to the Fire Department. All
alarm signals activated in the Hospital automatically activate a master alarm coded specifically
for [your laboratory]. This direct connection with the Fire Department is in compliance with local,
state and federal regulations. Hospital personnel are not permitted to investigate the emergency
area to determine whether or not the assistance of the Fire Department is necessary. All fires,
regardless of size, must be reported to the Fire Department. When responding to a Hospital fire
alarm, Fire Department and equipment arrive at two staging areas. These are:

• Street One

• Entrance two

2. Hospital security personnel meet the Fire Department at these staging areas and direct them to
the scene of the fire.

3. In the Hospital, a telephone operator determines the location of the emergency by identifying the
fire alarm code on the master list. The Hospital Fire Brigade, the Safety Officer and appropriate
administrative personnel are notified via a hot-line emergency telephone (RED PHONE), by the
individual paging system, and by the Hospital paging system.

4. A Fire emergency announcement over the general paging system is preceded by eleven (11)
bells then, the message is given - "Code Red, (Building), (Location)."

V. ALL CLEAR

(Describe the procedure followed by your lab)

1. Personnel accountability is established for each department.

2. When the fire emergency is over and personnel accountability has been established, the alarm

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will end and the Fire Department will announce “All Clear”.

3. The building may be reoccupied once the “All Clear” is announced.

VI. FIRE INCIDENT RESPONSE EVALUATION

1. Whenever a fire occurs in [your laboratory], a report of Fire Incident Response Evaluation form,
(Appendix 3.1) or appropriate incident form, must be completed as soon as possible after the fire
is extinguished.

2. The incident report is the responsibility of the senior supervisor of the area involved, such as
Nurse-in-Charge, Technician-in-Charge, Safety Officer or Office Manager.

3. The Fire Incident Response Evaluation form (Appendix 3.1) is an important part of the fire
response evaluation procedure. It is a self evaluation checklist which indicates the proper fire
emergency responses. It provides a permanent record of fire drills and actual fires. The
information requested also alerts the Office of Health, Safety and Environmental of any
malfunctions in the fire emergency signaling system. The form is provided to departments.

VII. EVACUATION PLAN

1. Mass evacuation of patient areas is to be undertaken only as a last resort and only on orders
from competent authority, i.e. Fire Department, the Office of Health, Safety and Environmental,
or Security Shift Supervisor.

2. Limited evacuation, generally horizontally, to another building or another wing of the same
building may be undertaken at any time as conditions dictate.

3. Whenever possible, elevators are not to be used in evacuation. Power failure may trap
occupants between floors. Opening elevator doors will create added drafts, gently accelerating
the spread of smoke and/or fire.

4. Elevators remote from the fire in other buildings or building separation may be used if specifically
directed.

5. Should evacuation be necessary, remove patients from danger area:


• Non-ambulatory patients - Roll beds out to a designated area or remove patients by the
various emergency carries.

• Wheelchair patients - Wrap patients in blankets and move to a designated area. Carry
patients down steps if necessary.

• Ambulatory patients - Wrap patients in blankets or bathrobes and assist them to a


designated area or down steps if necessary.

6. The evacuation plan should be posted in the form of a diagram in all areas of the laboratory.
Arrows should indicate the route to the nearest exit. (Appendix 3.2)

VIII. TRAINING

1. Fire Drills

• [Announced/Unannounced] fire exit drills will be conducted [frequency] in order to prepare


employees to respond safely in the event of a fire.

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• They will be held in the laboratory in order to educate the occupants in the facility’s fire safety
features and exits and to test the ability of institutional personnel to implement the facility’s
fire emergency plan. They will also be used to evaluate the escape routes.

• The drills will ensure that fire exit corridors and stairwells are clear and that all fire exit doors
open properly.

• All personnel are required to exit the area. All personnel must participate in at least one fire
drill annually.

• Attendance will be documented on a personnel accountability roster, which will be filed with
the site Incident form or the Fire Investigation Response Evaluation, Appendix 3.1.

2. Fire Extinguishers

• Personnel will be familiarized with the fire extinguisher location during their initial safety
training. There are [number] fire extinguisher(s) located in the following labs [locations]

• They will be instructed in the PASS method for fire extinguisher use:

a. Pull the pin.


b. Aim at the base of the fire.
c. Squeeze the handle.
d. Sweep side to side

• They will be knowledgeable in the fire classifications:

a. Class A - Ordinary combustibles such as wood, paper, cloth and most plastics.
b. Class B - Flammable liquids and gases such as gasoline, oils, paint, lacquers and
greases.
c. Class C - Energized electrical equipment where non-conductivity of the extinguishing
agent is important.
d. Class D - Combustible metals such as magnesium or titanium, (highly specialized, will
not be covered here).

• There are five common groups of extinguishing agents. Staff will be instructed in how to
choose one which will handle the correct class of fire while keeping damage at a minimum:

a. Dry Chemical, Useful on Class B and C fires. Leaves a mildly corrosive residue
Standard - which must be cleaned up immediately to prevent damage to electrical
equipment. Best uses are automotive, grease fires and flammable
liquids.
b. Dry Chemical, Useful for Class A, B, and C fires. Versatile and effective on most
Multipurpose common types of fires. Highly corrosive and leaves a sticky residue.
Not for use around delicate electrical appliances or computers.
c. Halogenated Useful on Class A, B, and C fires (depending on agent used, check
Agents labels). Expensive, but very versatile and clean. Leaves no residue.
Mildly toxic. Excellent for delicate computers and electrical equipment.
Also good for flammable liquids and automotive use. This is one of the
best all around choices for offices; however, environmental restrictions
and rising costs limit availability.
d. Carbon Dioxide Useful on Class B and C fires. Very clean, no residue. Short range
(must be applied close to fire).
e. Water Based Use on Class A fires only. Inexpensive to refill and maintain.
Agent

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• Local authority [does/does not] permit the use of fire extinguishers by laboratory personnel to
fight fires. If permitted, they must be instructed in the use of portable fire extinguishers.
There must be documentation that laboratory personnel have been trained to use fire
extinguishers. This should include actual operation of extinguishers that might be used in the
event of a fire.

3. Fire Blankets

• Personnel will be familiarized with the fire blanket location during their initial safety training.
There are [number] fire blanket(s) located in the following labs [locations]

• The fire blanket will be used to put out clothing fires as chemical extinguishers may be
harmful to the skin.

• The fire blanket is contained in a [plastic bag, cylinder, etc]. Pull the blanket out and wrap
around the victim tightly to extinguish any flames. It may be necessary to get the victim down
on the floor to roll and further block the oxygen source to the fire.

• Fire blankets will be checked monthly to verify location.

IX. FIRE EXTINGUISHER MAINTENANCE –


1. The laboratory is responsible for the inspection, maintenance and testing of all portable fire
extinguishers.

2. Portable extinguishers (or hose) will be visually inspected monthly and documented.

3. Portable fire extinguishers will receive an annual maintenance check. (Stored pressure
extinguishers do not require an internal examination.) The annual maintenance date will be
documented and retained for one year after the last entry or for life of the shell, whichever is
shorter.

4. Stored pressure dry chemical extinguishers that require a 12-year hydrostatic test will be emptied
and subjected to applicable maintenance procedures every 6 years. (Dry chemical extinguishers
having non-refillable disposable containers are exempt from this requirement.) When recharging
or hydrostatic testing is performed, the 6-year requirement begins from that date.

5. Alternate equivalent protection will be provided when portable fire extinguishers are removed
from service for maintenance and recharging.

6. Portable extinguisher certification records will include the date of the test, the signature of the
person who performed the test and the serial number, or other identifier, of the fire extinguisher
that was tested. These records will be kept until the extinguisher is retested or taken out of
service.

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APPENDIX 3.1

Fire Investigation Response Evaluation

1) Drill or actual event

2) Announced / Unannounced

3) Fire Response Team notified at: Arrival:

4) 100% Personnel accountability: yes / no at:

5) Accountability Rosters Attached: yes / no Comments:

6) Verify the following: Comments:


All alarms sounded: yes / no

Doors/Windows closed: yes / no

Personnel Evacuated: yes / no

7) Comments:

8) Future Preventive Actions:

9) Signatures:
Name Title Signature Date

Lab Manager

Lab Director

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Appendix 3.2 - Example of an Evacuation Plan

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Appendix 4 – Biosafety SOP
Author: Document Number: Fac10-13-App 4
Penny Stevens Effective (or Post) Date: 17-Feb-09
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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Appendix 4 – Biosafety SOP

Penny S. Stevens MBS, MT (ASCP), Document Number Effective Date


Author(s), Name & CLS (NCA)
Title
Fac10-13-SOP 17 Feb 2009
International QA/QC Coordinator
Appendix 4
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when
considering their use in other applications. If you have any questions contact SMILE.

Name, Title Signature Date


Approved By

Name, Title Signature Date

SOP Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
History 2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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APPENDIX 4
PRINCIPLES OF BIOSAFETY

I. DEFINITIONS

1. BSC - Biological Safety Cabinet


2. BSL - Biological Safety Level
3. PPE – Personal Protective Equipment
4. UV – Ultraviolet Light

II. TABLE OF CONTENTS

1. Containment
2. Primary Containment
3. Secondary Containment
4. Biosafety Levels
5. Table of Biological Safety Levels
6. Biological Safety Cabinet

III. CONTAINMENT

1. The term "containment" is used in describing methods for managing infectious agents in the
laboratory environment where they are being handled or maintained.

2. The purpose of containment is to reduce exposure of laboratory workers, other persons, and the
outside environment to potentially hazardous agents. The elements of containment include
laboratory practices and techniques, safety equipment, and facility design.

• Primary containment, the protection of personnel and the immediate laboratory environment
from exposure to infectious agents, is provided by good technique and the use of appropriate
safety equipment.

• Secondary containment, the protection of external laboratory environment from exposure to


infectious materials, is provided by a combination of facility design and operational practices.

IV. PRIMARY CONTAINMENT

1. The most important element of primary containment is strict adherence to standard biohazard
safety practices and techniques. Persons working with infectious agents or materials must be
aware of potential hazards and be trained and proficient in the practices and techniques required
for handling such material safely. The supervisor is responsible for providing or arranging for
appropriate training of personnel.

2. Additional measures may be necessary when standard laboratory practices are not sufficient to
control the hazard associated with a particular agent or laboratory procedure. The selection of
additional safety practices is the responsibility of the laboratory supervisor and must be
commensurate with the inherent risk associated with the agent or procedure.

3. Each laboratory must develop or adopt a safety manual, which identifies the hazards that may be
encountered and specifies practices designed to minimize or eliminate risks. Personnel should
be advised of special hazards and should be required to read and follow the required practices
and procedures. In the Microbiology Laboratory, activities must be supervised by a microbiologist
who is trained and knowledgeable in appropriate laboratory techniques, safety procedures and
associated risks.

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4. Laboratory personnel safety practices and techniques must be supplemented by appropriate


facility design and engineering features, safety equipment, and management practices.

V. BIOSAFETY LEVELS

1. An important element of secondary containment is the use of Biosafety Levels (BSL’s). These
guidelines specify four BSL’s with the potential safety hazards posed by the infectious agents for
which the laboratory is responsible. The levels are determined by of a combination of laboratory
practices and techniques, potential hazard posed by the infectious agents, degrees of protection
provided to personnel, safety equipment, and the laboratory facilities.

2. The object of these guidelines is to inform the laboratory staff of the safety practices required
when handling potentially hazardous organisms and biological materials.

3. Each laboratory worker is responsible for his/her own safety, the safety of his/her fellow worker
and training in the safety methods used in the laboratory. Remember: the most expensive
equipment is not a substitute for careful technique.

4. Biosafety Level 1. (BSL-1) - Safety equipment and facilities must be appropriate for laboratory
personnel with specific training in the procedures conducted in the laboratory. The personnel
should be supervised by a scientist with general training in microbiology or a related science.
Work in these areas will generally be conducted on open bench tops using standard
microbiological practices. Special containment equipment or facility design is neither required nor
generally used.

• Standard Microbiological Practices –

a. Access to laboratory should be limited or restricted at the discretion of lab director


when work or experiments on cultures and specimens are in progress.
b. A biohazard sign should be posted at the entrance to the laboratory. The sign should
include the name of the agents in use and the names and phone numbers of the lab
contacts.
c. Lab coats, gowns or uniforms should be worn to prevent contamination or soiling of
street clothes and should remain in the laboratory unless decontaminated.
d. Gloves (non- latex) should be worn.
e. Protective eyewear must be worn for procedures in which splashes of microorganisms
or other hazardous materials are anticipated.
f. Procedures are performed to minimize splashes or aerosols.
g. Staff must wash their hands after handling viable materials, after removing gloves, and
before leaving lab.
h. Work surfaces must be decontaminated at least once a day and after any spill of
viable material.
i. All cultures, stocks, and other regulated wasted must be decontaminated before
disposal by an approved decontamination method such as autoclaving
j. Refer to the General Lab Safety Policy (Fac1.0-13) for additional safety requirements.

• Facilities

a. Lab doors have access control.


b. Each lab has a sink for hand washing.
c. Lab is easily cleaned. No carpet or rugs in lab area.

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d. Bench tops are impervious to water.
e. Spaces between benches, cabinets, and equipment are accessible for cleaning.

5. Biosafety Level 2. (BSL-2) - This level should be adopted when work involves agents of
moderate potential hazard to personnel and environment.

• Standard Microbiological Practices:

a. All BSL-1 requirements.


b. Work surfaces are decontaminated with material specifically effective against the
agent of concern.

• Special Practices:

a. Biohazard sign must be posted on entrance to lab when etiologic agents in use. The
sign must include names and telephone numbers of lab contacts, personnel protective
equipment required in lab, agents or microbes in use and biosafety level of lab.
b. Lab personnel must receive appropriate immunizations or tests for the specific agents
handled. When appropriate a base line serum sample is collected and stored.
c. Biosafety procedures are incorporated into standard operating procedures. Personnel
are advised of special hazards.
d. Lab director ensures the lab personnel receive appropriate training on potential
hazards associated with work involved and precautions to prevent exposure and
evacuation procedures. Personnel receive annual updates or training as necessary for
policy and procedure changes.
e. Use a high degree of caution with any contaminated sharp items, including needles
and syringes, slides, pipettes, capillary tubes, and scalpels. Substitute plastic for
glassware whenever possible.
f. Cultures, tissues, body fluid specimens, or potentially infectious wastes are placed in a
container with a cover that prevents leakage during collection, handling, processing,
storage and transport.

• Safety Equipment and Facilities – They should be applicable to indigenous moderate-risk


agents present in the community and associated with human disease of varying severity.
Organisms and activities with low aerosol potential can be conducted on the open bench
using good microbiological techniques i.e., hepatitis agents, salmonellae, and Toxoplasma
spp.

• Primary barriers include: Biological safety cabinets, splash shields, face protection, protective
lab coats, gowns and gloves.

• Secondary barriers include: Hand washing and waste decontamination facilities to reduce
potential environmental contamination.

• Eyewash station is readily available.

• Furniture is covered with non-fabric material that can be decontaminated.

• Lockable doors are provided for restricted agents.

• Examples of high-risk steps in the laboratory would include:

a. Specimen Collection (e.g. needle sticks)


b. Specimen Processing (e.g. spills in transit, aerosols from improper centrifugation,
removal of stoppers, decanting of serum or plasma with external contamination of
containers and/or work surfaces)

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c. Specimen Analysis
d. Disposal of Specimen (e.g. failure to separate specimen containers from non-
infectious laboratory waste)
e. Procedures with high aerosol potential may predictably and significantly increase the
risk of exposure of personnel to infectious aerosols and must be conducted in primary
containment equipment or devices.

6. Biosafety Level 3. (BSL-3) - Applicable to work with indigenous or exotic agents, which may
cause serious and potentially lethal infections or disease as a result of exposure by inhalation
i.e., Mycobacterium tuberculosis, St. Louis encephalitis virus, and Coxiella burnetii

• Standard Microbiological Practices – all BSL-1 and BSL- 2 restrictions apply.

• Special Practices

a. Laboratory doors are kept closed when work is in progress.


b. The laboratory director controls access and restriction to the lab.
c. Biosafety manual must be specific to the laboratory and prepared or adopted by the
lab director and biosafety precautions are incorporated in the procedures.
d. All manipulations involving infectious material are conducted in biological safety
cabinets. Clean up is facilitated by using plastic backed paper toweling on non-
perforated work surfaces within biological safety cabinets.
e. Equipment must be decontaminated before removal from the facility for repair or
maintenance or packaging for transport.
f. All spills and exposures are reported to the laboratory director. Appropriate medical
evaluations, surveillance, and treatment are provided and records maintained by
management.

• Safety Equipment (Primary barriers) include:

a. Biological safety cabinets (BSC) or other enclosed equipment must be used for ALL
laboratory manipulations. No culture work should be done on open benches.
b. Protective clothing such as solid front or wrap-around gowns, scrub suits, or overalls
must be worn by workers in the lab. Along with all barriers listed under BSL-1 and
BSL-2.
c. Laboratory clothing that protects street clothing (i.e., solid front or wrap-around gowns,
scrub suits, coveralls, etc.) must be worn in the laboratory. FRONT-BUTTON
LABORATORY COATS ARE UNSUITABLE. Laboratory clothing must not to be worn
outside of the laboratory and must be decontaminated before laundered.

• Laboratory Facilities (Secondary barriers) include:

a. The lab is separated from areas with unrestricted traffic. Access to the laboratory is
controlled. Laboratory doors are kept closed when cultures are being processed or
identified. Access must be through a set of self-closing double doors.
b. A ducted exhaust air ventilation system must be provided and a specialized ventilation
system that creates a directional airflow which draws air into the laboratory from clean
areas toward contaminated areas. This minimizes the release of infectious aerosols
from the laboratory to clean areas.
c. Biosafety cabinets are required and must be located away from doors, ventilation
systems, and from heavily traveled lab areas.
d. All windows must be closed and sealed. The interior surfaces of walls, floors, and
ceilings of areas where BSL- 3 agents are handled must be constructed for easy
cleaning and decontamination. Seams, if present, should be sealed. All surface areas
should be impermeable to liquids and resistant to damage from the chemicals and

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disinfectants normally used in the laboratory.
e. The laboratory supervisor will assure that only persons who have been advised of the
potential biohazard, meet any of the specific entry requirements (e.g. immunization
and baseline serum), and comply with all entry and exit procedures are permitted to
enter the laboratory.
f. When infectious materials are present in the laboratory, a hazard warning sign,
incorporating the universal biohazard symbol, is posted on all laboratory access doors
and on other items (i.e., equipment, containers, materials, etc.) as appropriate to
indicate the presence of viable infectious agents. The hazard warning sign should
identify the agent, list the name of the laboratory supervisor and another responsible
person(s), and indicate any special conditions of entry into the area (immunizations,
respirators, etc.).

• Primary hazards to personnel working with these agents include auto- inoculation, ingestion,
and exposure to infectious aerosols.

• Examples of high-risk steps in the laboratory are the same as BSL-1 & 2.

7. Biosafety Level 4. (BSL-4) - Applicable to working with dangerous and exotic agents, which
pose a high individual risk of life-threatening disease. All manipulations of potentially infectious
diagnostic materials, isolates, and naturally or experimentally infected animals, pose a high risk
of exposure and infection to laboratory personnel. Lassa fever and Ebola viruses are examples
of BSL-4 microorganisms. This level is not applicable to the diagnostic laboratories.

VI. BIOSAFETY LEVEL TABLE

Safety Equipment Facilities


BSL Agents Practices
(Primary Barriers) (Secondary Barriers)

Not known to Lab coats, gowns or


Standard
consistently uniforms Gloves, protective Open bench top & sink
1 Microbiological
cause disease in eyewear where potential required
practices
healthy adults splashes anticipated

Primary barriers: BSC or


Associated with BSL-1 plus
physical containment
human disease. limited access
devices used for all
Hazards are Biohazard
manipulations of agents
percutaneous. warning signs. BSL-1 plus: Autoclave
2 that cause splashes or
Injury, ingestion, Sharps available
aerosols of infectious
& mucous precautions, &
materials. PPE’s: lab coats,
membrane biosafety
gloves, & face protection as
exposure manual
needed

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BSL-2 plus:
Indigenous or controlled
Primary barriers: BSC or
exotic agents access, BSL1 &2 plus: Physical
other physical containment
with potential for decontamination separation from access
devices used for all open
aerosol of all waste, corridors ,Self-closing
manipulations of agents.
3 transmission. decontamination double door access,
Standard PPE plus:
Disease may of lab clothing exhausted air not re-
additional protective lab
have serious or before circulated and negative
clothing and respiratory
lethal laundering, & airflow lab
protection as needed
consequences. baseline serum
tests
4 Not applicable to the diagnostic laboratory

VII. BIOLOGICAL SAFETY CABINET - BSCs are designed to provide personnel, environment and product
protection when appropriate practices and procedures are followed. Three kinds of biological safety
cabinets, designated as Class I, II and III have been developed to meet varying clinical needs.

1. Class I - has negative pressure with minimum face velocity of 75 linear feet per minute (Lfmp)
and all of the air from the cabinet is exhausted through a HEPA filter either into the laboratory or
to the outside. Class I BSCs are no longer being manufactured on a regular basis and many
have been replaced by Class II BSCs. Class I BSC’s may be used for centrifuges, harvesting
equipment or blenders but do not provide a microbe free work environment.

2. Class II

• Personnel protection is provided with the air flow being drawn around the operator inward
with a face velocity of 75 - 100 Lfpm, HEPA - filtered vertical laminar airflow provide product
protection by minimizing cross-contamination along the work surface of the cabinet, and
HEPA filter exhaust air for environmental protection. All Class II cabinets are designed for
work with microorganisms assigned biosafety levels 1, 2, and 3. They provide a microbe free
work environment. They are not to be used with volatile or toxic chemicals.

• An example of the Class II vertical laminar-flow biological cabinet (type A) is an open-fronted,


ventilated cabinet with an average inward face velocity at the work opening of at least 75 feet
per minute. This cabinet provides a HEPA-filtered, recirculated mass airflow within the work
space. The exhaust air from the cabinet is also filtered by HEPA filters. Design, construction,
and performance standards for Class II cabinets have been developed by and are available
from the National Sanitation Foundation, Ann Arbor, Michigan.

3. Class III - is totally enclosed, ventilated cabinet of gas-tight construction and has the highest
degree of personnel and environmental protection from infectious aerosols, as well as protection
of research materials from microbiological contamination. Used mostly for work with hazardous
agents that requires Biosafety levels 4 containment. All work is done through attached rubber
gloves and the cabinet is operated under negative pressure. Supply air is HEPA filtered, and
cabinet exhaust air is filtered by two HEPA filters in series. Class III must be connected to
double-doored auto claves and chemical dump tanks to sterilize or disinfect all materials exiting
the cabinet.

4. BSC effectiveness is a function of directional air flow (inward and downward), through a "high
efficiency particulate air" (HEPA) filter. Rapid movement can disrupt the airflow and reduce
effectiveness i.e., rapidly moving your arms in and out of the BSC and people walking rapidly
behind you. For best results, Class I and II BSCs should be located away from traffic patterns,
doors, ventilation systems, and air handling devices.

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5. BSC Operation:

• Do NOT place objects on or over front air intake grille.


• Do NOT block rear exhaust grille.
• Arrange materials to segregate contaminated and clean items.
• Work should be performed at least six (6) inches back from front grille.
• Inside the BSC, always use horizontal pipette discard pans, containing appropriate
disinfectant.
• Clean up all spills immediately. Wait 5 minutes before resuming work.

6. BSC Maintenance:

• Cabinets should be decontaminated at least once per day after completion of work
processes.
• UV Lights should be maintained as indicated in Fac1.0-13 Appendix 5-Electrical &
Mechanical Safety.
• Cabinets must be certified at least annually to ensure that filters are functioning properly and
that airflow rates meet required specifications.

VIII. Resources

1. NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition. NCCLS document GP17-A2
[ISBN 1-56238-530-5]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2004.
2. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline-Third Edition. CLSI document M29-A3 [ISBN 1-56238-567-4].
Clinical and Laboratory Standards Institue, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2005.
3. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory
Accreditation Program; Laboratory General Checklist Revised 9/27/2007.
4. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory
Accreditation Program; Microbiology Checklist Revised 9/27/2007.
5. CDC-NIH U.S. Department of Health and Human Services Primary Containment for Biohazards:
Selection, Installation and Use of Biological Safety Cabinets, Sept 2000, 2nd Edition.
6. ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit Values. 1994-
1995. Cincinnati, OH.
7. McKinney, Robert, Richard Jonathan. CDC/NHI Department of Health and Human Services, Biosafety in
th
Microbiological and Biomedical Laboratories 4 Ed. May 1999. U.S. Government Printing Office. H.H.S.
Publication No. (CDC) 93-8395.
8. Occupational exposure to hazardous chemicals in laboratories, OSHA laboratory standards
29CFR1910.1450
9. Infection Control: The Johns Hopkins Hospital Interdisciplinary Clinical Practice Manual (ICPM)
10. Infection Control Policy 1998, Osler 4,
11. The Johns Hopkins Institutions Office of Health, Safety and Environmental, Johns Hopkins Safety
Manual. 2001, 2024 E. Monument St. Telephone 955-5918
12. CDC-NIH U.S. Department of Health and Human Services Biosafety in Microbiological and Biomedical
th
Laboratories, May 1999, 4 Edition. (HHS Publication No. (CDC) 93-8395).

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Appendix 5 – Electrical and Mechanical Safety SOP

Author: Document Number: Fac10-13 App 5


Penny Stevens Effective (or Post) Date: 17-Feb-09
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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Baltimore, MD USA

Appendix 5 – Electrical and Mechanical Safety SOP

Penny S. Stevens MBS, MT (ASCP), Document Number Effective Date


Author(s), Name & CLS (NCA)
Title
Fac10-13-SOP 17 Feb 2009
International QA/QC Coordinator
Appendix 5
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when
considering their use in other applications. If you have any questions contact SMILE.

Name, Title Signature Date


Approved By
Jo Shim MBA, MT(ASCP)

Name, Title Signature Date

SOP Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
History 2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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APPENDIX 5
ELECTRICAL AND MECHANICAL SAFETY

I. DEFINITIONS

UV – Ultraviolet

II. TABLE OF CONTENTS

1. Electrical Safety
2. Compressed gases
3. Liquid Nitrogen
4. Mechanical safety
5. Ultraviolet Lights
6. Emergency Equipment

III. ELECTRICAL SAFETY

1. Grounding: All instruments must be grounded including household type appliances, coffee pots,
etc. The only exceptions to the rule are items entirely encased in plastic (such as microscopes).

2. Report shocks: All shocks must be reported immediately, including small tingles. Small shocks
often precede major shocks and a light tingle may indicate potential trouble. Notify supervisory
personnel of any shocks.

3. Corrective actions: Shut off the current and/or unplug the instrument. Do not attempt to use an
instrument that is causing shocks. Instrument shocks are potentially dangerous and render all
results as suspect or unreliable.

4. Repairs: DO NOT work on or attempt to repair any instrument while it is plugged in. This does
not apply to instrument calibrations. Calibrations must be performed while the instrument is
plugged in. In this case, be sure hands are dry, remove all jewelry (watches and rings) and
proceed with caution. Repairs on the electrical system of the building are prohibited. Any work
performed on switches, outlets or circuit boxes (fuses, circuit breaker) must be referred to the
building maintenance personnel. Extension cords should be avoided. If used, they must be
properly grounded. Chains of extension cords plugged into each other are prohibited. New
equipment using electrical power should be checked for absence of chassis leaks and other
safety hazards by a Biomedical Engineering Technician.

IV. COMPRESSED GASES

1. Compressed gases constitute several hazards. Any gas cylinder with a broken valve head
becomes a missile capable of penetrating walls. Specific gases may be toxic or flammable. In
addition, heated cylinders may result in explosion.

2. All compressed gas cylinders shall be secured in an upright position by means of a strap or
chain. This includes cylinders in use or in storage (empty or full).

3. Suitable hand carts will be utilized when transporting gas cylinders. Cylinders must be restrained
to the hand cart by means of a strap or chain during transport.

4. Protective valve caps must be in place when cylinders are not in use.

5. All cylinders, lines, and equipment used with flammable compressed gases must be grounded.

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6. All cylinders must be equipped with an appropriate regulating device while in use. All regulators
must be marked to identify the gas (or group of compatible gases) with which the regulator may
be used. Regular threads must match cylinder valve outlet threads.

7. All cylinders must have an attached hand wheel, valve handle, spindle key, or special tool to
open and close the cylinder valve while in use in the event of an emergency.

8. Cylinders containing compressed gases shall be used only in well-ventilated areas.

9. Cylinders containing toxic or flammable gases must be stored in an approved storage area. It is
recommended that the smallest possible cylinder of toxic or flammable gases be used.

10. Cylinders containing oxidizing gases, such as oxygen and nitrous oxide, must be stored
separately from flammable gases or liquids.

11. Empty cylinders must be so identified and stored separately from full or partially full cylinders.

12. Compressed gas cylinders shall be used only for their intended purposes.

13. Cylinders must not be stored with or near flammable materials.

14. Do not use oil, grease or lubricants on valves, regulators or fittings.

15. Do not attempt to repair damaged cylinders or to force frozen cylinder valves.

16. Flammable Compressed Gas

• Special care must be used when gases are used in confined spaces.

• No more than two cylinders should be manifolded together.

• More than one instrument or outlet is permitted for a single cylinder.

• No more than one cylinder of highly flammable gas shall be in one room without specific
approval by the Director (or Safety Officer).

• Reserve or standby cylinders (full or empty) must not be stored in the lab.

• Cylinder size is limited to 200 cubic feet. Valves on all flammable gas cylinders shall be shut
off when the laboratory is unattended.

• Pressure regulators and needle valves: Needle valves and regulators are designed
specifically for different families of gases. Use only the properly designated fittings.

• Threads and surfaces must be clean and tightly fitted. Do not lubricate.

• Tighten regulators and valves firmly with the proper sized wrench. (Do not use adjustable
wrenches or pliers. They damage the nuts.) Do not force tight fits.

• Open valves slowly. Do not stand directly in front of gauges (the gauge face may blow out).
Do not force valves that "stick".

• Check for leaks at connections. Leaks are usually due to damaged faces at connections or
improper fittings. Do not attempt to force an improper fit. (It may only damage a previously
undamaged connection and compound the problem.)

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• Valve handles must be left attached to the cylinders.

• The maximum rate of flow should be set by the high pressure valve on the cylinder. Fine
tuning of flow should be regulated by the needle valve.

• Shut off cylinders when not in use.

17. Leak testing: Cylinders and connections should be tested by "snoop" or a soap solution. First,
test the cylinders before regulators are attached, and then test again after the regulators or
gauges are attached.

18. Empty cylinders must be marked empty, and remain secured in an upright position with a safety
cap in place.

V. LIQUID NITROGEN - Liquid Nitrogen is extremely cold. At atmospheric pressure, liquid Nitrogen boils at
o
–196 C. Very small amounts of liquid vaporize into large amounts of gas. One liter of liquid nitrogen
3
becomes 0.7 m of gas and can displace oxygen resulting in asphyxiation. Refer to the liquid nitrogen
safe handling SOP for detailed safety requirements.

VI. MECHANICAL SAFETY – Use caution in the operation and maintenance of laboratory equipment and
furnishings, with attention to the following general hazards:

1. Pinch points (e.g. hinges, pliers, etc.)


2. Catch points (which may catch either a person or his clothing)
3. Shear points (doors, cabinet drawers)
4. Squeeze points (between moving parts)
5. Run-in points (rotating parts moving toward each other, e.g. meshing gears)
6. Flying objects (metal or glass from breakage or explosion)
7. Falling objects (Use caution when storing or removing heavy items from cabinets and overhead
shelving.)
8. Sharp or pointed objects (Do not handle syringes or other collecting systems with needles still
attached.)

VII. ULTRAVIOLET LIGHTS

1. In general, ultraviolet radiation is used to reduce exogenous contaminants and/or pathogenic


microorganisms on exposed surfaces and in the air.

2. Under certain conditions of radiation intensity, exposure time, humidity, and temperature,
ultraviolet radiation at approximately 254 nanometers will cause eventual death of
microorganisms. The radiation at this wavelength causes formation of thymine-thymine dimers
and other effects on DNA and RNA. Nucleic acid containing thymine dimers does not replicate
properly and lethal mutations are often produced. Low pressure mercury vapor lamps, usually
supplied with biological safety cabinets, emit germicidal radiation at a wavelength of 254
nanometers for about nine months. After this time, the lamp may not produce enough germicidal
radiation to effectively kill bacteria, even though it appears to be functioning properly.

3. All UV installations used for disinfection/decontamination should be checked and certified semi-
annually by qualified personnel. Periodic examination is necessary because UV bulbs may
continue to burn without emitting effective radiation. UV lamps should be replaced when they
emit 70 percent or less of their rated initial output.

4. UV lamps installed in biological safety cabinets must be replaced when the 254 nm UV irradiation
intensity on the work tray surface of the cabinet is less than 40 microwatts per square centimeter.

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5. UV lamps should be cleaned often if located in an unusually dusty area. Lamps should be turned
off and wiped with a soft pad moistened with alcohol. Cleansing is the responsibility of the
personnel in charge of the laboratory.

6. All exposed UV installations in lighting fixtures and safety cabinets shall be turned on only when
no personnel are in the area. Louvered, wall mounted UV equipment may be left on
continuously.

7. Each UV installation should be equipped with an outside switch and an appropriate safety sign.
Interlocks should be installed where appropriate to turn off UV lamps when room lights are turned
on.

8. All personnel should be instructed in the proper use of each UV installation. Such instruction
should include emphasis on the following:

• Do not look directly at UV lamps;


• Do not loiter in UV airlocks and door barriers;
• Turn off lamps before cleaning;
• Wear eye and skin protection if anticipated exposure to UV will be for longer than a few
seconds;
• Protective goggles should transmit less than 4% of 400 nm wavelength light
• Particular care needs to be exercised around UV gel transilluminators, as they produce
considerable radiation.

VIII. EMERGENCY EQUIPMENT:

1. The following emergency equipment will be present in the laboratory:

[list emergency equipment]

Emergency eyewash should be within 30 meters or 10 seconds travel distance from every area
of the laboratory in which hazardous chemicals are used.

2. Emergency equipment must be verified for proper maintenance with the frequency noted below.
Documentation must be retained in the laboratory for a minimum of two years after the life of the
equipment or indefinitely.

3. Eyewash/shower - solution must be sterile saline, an antiseptic ophthalmic solution within date,
or fresh running tap water. The system will provide lavage solution free of contaminants.
Plumbed equipment must be activated weekly to verify proper operation:

• Access is within 10 seconds from hazard and not obstructed.


• The control valve is easily located and can be turned from off to on in one second.
• Water temperatures are to be tepid.
• Eye wash nozzles are covered. Caps are intact and clean.
• Eye wash height of the stream of water is to be 3 – 6 inches in order to assure correct
pressure (soft spent stream).
• Safety shower height is between 2 – 2.4 meters
• Document the weekly operation checks and any corrective actions on the Emergency
Equipment Maintenance Log. See appendix 5.1

4. Fire Blankets - Are recommended. See appendix 5.1 for fire blanket information.

5. Fire Extinguishers - See appendix 5.1 for fire extinguisher maintenance requirements.

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6. Unserviceable equipment must be repaired and the corrective action noted. If the problem
cannot be corrected, place a work order with the facilities department at [number]

7. Training for Emergency Equipment: Any employee or student coming in contact with any
hazardous material shall have a local orientation to the actual chemicals and emergency
equipment in use at their site and in halls adjacent to laboratories.

• Training is the responsibility of the person in charge of the laboratory and must be
documented.
• Retain documentation in the employees training file.

IX. Internal Safety Audits - It is recommended that internal safety audits be performed on a defined
schedule. Refer to appendix 5.2 for an internal safety audit checklist.

X. Appendices

5.1 Emergency Equipment Maintenance Log


5.2 Internal Safety Audit Checklist and Corrective Actions

XI. Resources

1. NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition. NCCLS document GP17-A2
[ISBN 1-56238-530-5]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2004.
2. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline-Third Edition. CLSI document M29-A3 [ISBN 1-56238-567-4].
Clinical and Laboratory Standards Institue, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2005.
3. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory
Accreditation Program; Laboratory General Checklist Revised 9/27/2007.
4. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory
Accreditation Program; Microbiology Checklist Revised 9/27/2007.
5. CDC-NIH U.S. Department of Health and Human Services Primary Containment for Biohazards:
Selection, Installation and Use of Biological Safety Cabinets, Sept 2000, 2nd Edition.
6. ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit Values. 1994-
1995. Cincinnati, OH.
7. McKinney, Robert, Richard Jonathan. CDC/NHI Department of Health and Human Services, Biosafety in
th
Microbiological and Biomedical Laboratories 4 Ed. May 1999. U.S. Government Printing Office. H.H.S.
Publication No. (CDC) 93-8395.
8. Occupational exposure to hazardous chemicals in laboratories, OSHA laboratory standards
29CFR1910.1450
9. Infection Control: The Johns Hopkins Hospital Interdisciplinary Clinical Practice Manual (ICPM)
10. Infection Control Policy 1998, Osler 4,
11. The Johns Hopkins Institutions Office of Health, Safety and Environmental, Johns Hopkins Safety
Manual. 2001, 2024 E. Monument St. Telephone 955-5918
12. CDC-NIH U.S. Department of Health and Human Services Biosafety in Microbiological and Biomedical
th
Laboratories, May 1999, 4 Edition. (HHS Publication No. (CDC) 93-8395).

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APPENDIX 5.1

Laboratory Name
Emergency Equipment Maintenance Log

Month/Year Department:

Emergency
Equipment was Comes on Water pressure is Eye wash
Equipment Type: (Eye Eye wash caps Water feels Annual
Inventory run for at least 3 within one adequate based caps Corrective Tech Initials &
Wash, Drench hose, cleaned with 70% tepid to the Service
Number: minutes and until second of on visual and present and Action Date
shower, etc.) alcohol solution touch: Due:
water was activation: touch inspection: functional:
sediment free

Fire Extinguisher
Equipment Type: (Fire Equipment present Fire alarm is properly Annual
Inventory Equipment Expiration Tech Initials &
blanket, extinguisher, and easily test mounted, Service Corrective Action
Number: servicable: date valid: Date
alarm, etc.) accessible: performed: serviced & Due:
charged:

Chemical Spill Kit: N/A N/A N/A


Comments:

Supervisor Review: Date:

Comments:

All annual service activities are performed and documented by facilities personnel. Documentation copies are retained by the laboratory.

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Appendix 5.2

Laboratory Name
Internal Safety Audit Checklist
Yes No N/A
General Fire Safety
1 Safety Equipment is present and functional.
2 Sprinkler heads clear and unobstructed.
3 Exits signs and emergency lights operational
4 Laboratory doors remain closed at all times.
5 Applicable warning signs are posted to indicate flammable & biological hazards.
6 Emergency evacuation routes posted.
7 Emergency procedures written and available.
8 Equipment maintenance plans are written.
9 Aisles free of clutter and exit doors are not blocked.
10 Laboratory fume hoods and biosafey cabinets have current inspection / certification labels.
11 Flammable/combustible liquids are properly segregated and stored in approved safety cabinets.
12 Flammable/combustible liquids are stored away from ignition sources (burners, electrical units, etc.)
13 The quantity of flammable/combustible liquids does not exceed maximum storage limits.
14 Flammable cabinets or refrigerators are explosion proof and properly marked.
Gas Cylinders
15 All cylinders are stored in the appropriate locations.
16 All cylinders are properly restrained.
17 Regulators are present and appropriate for all 'in-use' cylinders.
18 Cylinders not in use are appropriately capped and labeled.
19 All cylinders, lines, and equipment used with flammable compressed gases must be grounded
Chemical Storage
20 Chemicals are stored properly and according to compatibility.

21 There is a current inventory and MSDS sheets for all chemicals used in the laboratory.
Electrical Safety
22 All electrical wiring is free of fraying and cuts.
23 All electrical devices are grounded.
24 Extensions cords are not used for permanent wiring.
25 Controls that turn equipment on and off are labeled appropriately.
26 Electrical receptacles, switches, and controls are located so as not to be subject to liquid spills.

Circuit breaker panels and electrical transformers are free of storage within 30 inches of the panel in
27 laboratories and mechanical spaces.

Auditor: Date:
Supervisor: Date:
Comments

Page 1 of 2

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Laboratory Name
Internal Safety Audit - Corrective Actions
Anticipated
Item
Finding Corrective Action Completion
number
Date

Auditor: Date:

Supervisor Review: Date:

Comments:

Pg 2 of 2

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Appendix 6 – Chemical Safety SOP


Author: Document Number: Fac10-13 App 6
Jo Shim Effective (or Post) Date: 17-Feb-09
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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Appendix 6 – Chemical Safety SOP

Jo Shim MBA, MT (ASCP) Document Number Effective Date


Author(s), Name &
Title Fac10-13-SOP 17 Feb 2009
International QA/QC Coordinator Appendix 6

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when
considering their use in other applications. If you have any questions contact SMILE.

Name, Title Signature Date


Approved By

Name, Title Signature Date

SOP Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
History 2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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APPENDIX 6 – Chemical Safety

CHEMICAL HAZARDS

I. DEFINITIONS

1. Hazardous material or chemical - any chemical, which is a physical or health hazard


2. MSDS – Material Safety Data Sheet

II. TABLE OF CONTENTS

1. Introduction
2. Chemical hazards in the laboratory: OSHA'S "Right to Know" law
3. Classification
4. Labeling
5. Chemical Lists
6. Storage of corrosives
7. Storage of flammables
8. Handling caustic materials
9. Breaks and spills
10. Mercury
11. Disposal of chemical wastes
12. Carcinogens
13. Suspected carcinogens

III. INTRODUCTION:

A number of routine procedures in a clinical laboratory involve the use of highly caustic, poisonous, or flammable
reagents. These should be appropriately labeled to indicate the hazards. Read labels and observe precautions.
Failure to follow safe practices is cause for disciplinary action.

IV. CHEMICAL HAZARDS IN THE LABORATORY: OSHA'S "RIGHT TO KNOW" LAW

1. The Occupational Safety and Health Administration (OSHA) has issued regulations regarding
education of employees regarding hazardous chemicals present in the workplace. All
laboratories, including clinical laboratories, will be required to:

• Have Material Safety Data Sheets (MSDS) accessible to employees for chemicals used in
the laboratory. An MSDS is a printed sheet (or computer file) listing product identification,
precautionary labeling, hazardous components, fire and explosion data, health hazard data,
spill and disposal procedures and similar information on individual chemicals or mixtures.
MSDS’s can be requested from the QA or Lab Manager, the manufacturer or obtained online
at http://www2.siri.org/msds/index.php.

• Label containers of chemicals properly; manufacturer's labels are acceptable.

• Train employees to recognize potential hazards in the workplace and proper procedures for
handling hazardous substances.

• Prepare a list of hazardous chemicals used in lab for inventory. The list of hazardous
chemicals used in the laboratory is to be updated and reviewed annually.

2. The employee's responsibility regarding chemical hazards.

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• Know the chemical hazards of the reagents you work with. Consult the procedure manuals
and refer to the MSDS files to learn the hazards of any chemical that you use before you
start a job. Not all prepackaged mixtures have an MSDS. Look at the MSDS of key
components.

• Handle and dispose of chemicals using good laboratory practice and as described in the
procedure manuals.

• Use safety appliances and PPE such as lab coat, gloves, goggles and fume hoods as
appropriate. Refer to MSDS file where appropriate. Notify a supervisor if any discrepancy
exists.

• Consult your supervisor if you have concerns regarding the hazard of any chemical or
procedure.

3. The Employee's Rights regarding Chemical Hazards.

• See the Chemical Information List and MSDS for hazardous substances in your workplace
within one day of your request.

• Be provided with one copy of the list of substances you use and the corresponding MSDS (or
the means to make a copy at no cost) within five days of a request.

• Be trained on the hazards of the chemicals in your workplace, on the appropriate equipment
and methods necessary to protect you from the hazards, and on associated emergency
procedures.

• Refuse to work with a hazardous chemical if denied access to information about that
chemical.

V. CLASSIFICATION - Dangerous chemicals are classified as follows:

1. Caustic or corrosive: Acids and alkalis may cause burns of skin, mouth, or eyes and may also
cause damage to equipment and storage areas.

2. Poisons: Almost any substance in quantity can be poisonous. For these purposes, a poison will
be classified as a substance which may cause death or serious effects if relatively small amounts
are inhaled, ingested, or contact the skin (such as concentrated phenols). Poisons may be gas,
liquid, or solid

3. Carcinogens: Substances designated by OSHA as carcinogenic (cancer causing) require special


handling.

4. Flammables: Such materials that easily ignite/burn and serve as fuel for a fire.

5. Explosive: Materials which may explode under special circumstances.

VI. LABELING:

1. Manufacturers are required to disclose and display appropriate hazard warnings on all chemicals
however, regular periodic inventories may reveal containers purchased before manufacturers
were required to use adequate and precautionary labeling. Therefore, the laboratory is also
required to ensure that containers of hazardous chemicals in use or in storage are labeled with
identity or contents of the container and the applicable hazard warnings.

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2. Existing labels on containers carrying hazardous chemicals should not be removed or defaced
unless the container is immediately marked with the required re-labeling information.

3. Any secondary container into which hazardous chemicals are transferred from originally labeled
containers must also be labeled with:

• The chemical identity of the contents


• Precautionary handling hazards.
• Date of receipt
• Date of preparation and/or date placed in service,
• Dilution ratio, if applicable
• Hazardous characteristics, i.e., caustic, corrosive, poisonous, carcinogenic, etc.
• Date of expiration.
• Labels or other forms of warning must be legible, in the same language as that used by
laboratory personnel and prominently displayed on the container.

4. The only permissible exceptions to this requirement are containers intended for immediate use
only by the person who does the transfer and only within the work shift in which the transfer was
made. Unlabeled containers of chemicals should not be used; such materials should be
disposed of promptly.

5. Certain manufacturers use the National Fire Protection Association System of identification. The
National Fire Protection Association (NFPA 704) "Identification of the Hazards of Materials" is a
symbol system. The diamond identifies the health, flammability, and reactivity hazards as well as
the severity using a 0-4 gradient, with 4 as the highest hazard. This system was designed to be
easily understood and adequate for fire fighters to evaluate hazards in emergencies at the
expense of some specificity and comprehensiveness.

6. The five degrees of hazard have these meanings to fire fighters:

• 4 - Too dangerous to approach with standard fire-fighting equipment and procedures.


Withdraw and obtain expert advice on how to handle.
• 3 - Fire can be fought using methods intended for extremely hazardous situations, such as
unmanned monitors or personal protective equipment which prevents all bodily contact.
• 2 - Can be fought with standard procedures, but hazards are present which require certain
equipment or procedures to handle safety.
• 1 - Nuisance hazards present which require some care, but standard firefighting procedures
can be used.
• 0 - No special hazards and no special measures.

7. Health Hazards (BLUE)

4 - Materials too dangerous to health to expose fire fighters. A few whiffs of the vapor could
cause death. Protective clothing and breathing apparatus, available to the average fire
department personnel, will not provide adequate protection against inhalation or skin contact
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with these materials.


3 - Materials extremely hazardous to health but areas may be entered with extreme care.
2 - Materials hazardous to health but areas may be entered freely with self-contained breathing
apparatus.
1 - Materials only slightly hazardous to health.
0 - Materials which on exposure under fire conditions, should offer no health hazard beyond that
of ordinary combustible material.

8. Flammability Hazards (RED)

4 - Very flammable gases or very volatile flammable liquids.


3 - Materials that can be ignited under almost all normal temperature conditions. Water may be
ineffective because of the low flash point in the materials.
2 - Materials that must be moderately heated before ignition will occur. Water spray may be
used to extinguish the fire because the material can be cooled below its flash point.
1 - Materials that must be preheated before ignition can occur. Water may cause frothing if it
gets below the surface of the liquid and turns to steam. However, water fog gently applied to
the surface will cause a frothing which will extinguish the fire.
0 - Materials that will not burn.

9. Reactivity or Stability Hazards (Yellow)

4 - Materials which are readily capable of detonation at normal temperatures and pressures. If
they are involved in a massive fire, vacate the area.
3 - Materials which, when heated and under confinement, are capable of detonation and that
may react violently with water. Fire fighting should be conducted from behind explosion-
resistant locations.
2 - Materials which will undergo a violent chemical change at elevated temperatures and
pressures but do not detonate.
1 - Materials which are normally stable but may become unstable in combination with other
materials or at elevated temperatures and pressures. Use normal precautions as in
approaching any fire.
0 - Materials which are normally stable and, therefore, do not produce any reactive hazard to fire
fighters.

Special Hazards (White)

Denotes an oxidizer, a chemical which can greatly increase the rate of


OX
combustion/fire.
Unusual reactivity with water. This indicates a potential hazard using water to fight
a fire involving this material.
ACID Indicates that the material is an acid or corrosive material with a pH less than 7.0
ALK Denotes an alkaline material (base) or caustic material with a pH greater than 7.0
COR Denotes a material that is corrosive (can be an acid or a base).

This is another symbol used for corrosive.

Used to denote a poison or highly toxic material. See also: CHIP Danger symbols.

Denotes radioactive hazards. Extremely hazardous when inhaled.

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Indicates an explosive material. Easily recognized by their instability rating.

VII. INCOMPATIBLE CHEMICALS

Chemical Incompatible with:


Alkaline and alkaline earth metals, Carbon dioxide, carbon tetra-chloride, and other chlorinated
such as sodium, potassium, cesium, hydrocarbons, any free acid or halogen. Do not use water, foam,
lithium, magnesium, calcium, or dry chemical on fires involving these metals.
aluminum
Acetic acid Chromic acid, nitric acid, hydroxyl-containing compounds,
ethylene glycol, perchloric acid, peroxide, and permanganates
Acetone Concentrated nitric and sulfuric acid mixtures
Acetylene Chlorine, bromine, copper, silver, fluorine, and mercury
Ammonia (anhydrous) Mercury, chlorine, calcium hypochlorite, iodine, bromine, and
hydrogen fluoride
Ammonium nitrate Acids, metal powders, flammable liquids, chlorates, nitrates,
sulfur, finely divided organics or combustibles
Aniline Nitric acid, hydrogen peroxide
Bromine Ammonia, acetylene, butadiene, butane and other petroleum
gases, sodium carbide, turpentine, benzene, and finely divided
metals
Calcium carbide Water (see also acetylene)
Calcium oxide Water
Carbon, oxide Calcium hypochlorite
Copper Acetylene, hydrogen peroxide
Chromic acid Acetic acid, naphthalene, camphor, glycerine, turpentine,
alcohol, and other flammable liquids, paper, or cellulose
Chlorine Ammonia, acetylene, butadiene, butane and other petroleum
gases, hydrogen, sodium carbide, turpentine, benzene, and
finely divided metals
Chlorine dioxide Ammonia, methane, phosphine, and hydrogen sulfide
Fluorine Isolate from everything
Hydrocyanic acid Nitric acid, alkalis
Hydrogen peroxide Copper, chromium, iron, most metals or their salts, any
flammable liquid, combustible materials, aniline, nitromethane
Hydrofluoric acid, anhydrous Ammonia, aqueous or anhydrous
(hydrogen fluoride)
Hydrogen sulfide Fuming nitric acid, oxidizing gases
Hydrocarbons (benzene, butane, Fluroine, chlorine, bromine, chromic acid, sodium peroxide
propane, gasoline, turpentine)
Iodine Acetylene, ammonia (anhydrous or aqueous)
Mercury Acetylene, fluminic acid ammonia
Nitric acid (concentrated) Acetic acid, aniline, chromic acid, hydrocyanic acid, hydrogen
sulfide, flammable liquids, flammable gases, and nitritable
substances
Fac1.0-13 Appendix 6-Chemical Safety Version#: 2.0 Page 8 of 13
SMILE
Johns Hopkins University
Baltimore, MD USA

Chemical Incompatible with:


Nitroparaffins Inorganic bases
Oxygen Oils, grease, hydrogen, flammable liquids, solids, or gases
Oxalic acid Silver, mercury
Perchloric acid oils, organic amines Acetic anhydride, bismuth and its alloys, alcohol, paper, wood,
or antioxidants grease,
Peroxides, organic Acids (organic or mineral); avoid friction
Phosparus (white) Air, oxygen
Potassium chlorate Acids (see also chlorate)
Potassium perchlorates Acids (see also perchloric acid)
Potassium permanganate Glycerine, ethylene glycol, benzaldehyde, any free acid
Silver compounds Acetylene, oxalic acid, tartaric acid, fulminic acid, ammonium
Sodium See alkaline metals (above)
Sodium nitrate Ammonium nitrate and other ammonium salts
Sodium oxide Water, any free acid
Sodium peroxide Any oxidizable substance, such as ethanol, methanol, glacial
acetic acid, acetic anhydride, benzaldehyde, carbon disulfide,
glycerine, ethylene glycol, ethyl acetate, methyl acetate, and
furfurol
Sulfuric acid Chlorates, perchlorates, permanganates
Zirconium Prohibit water, carbon tetrachloride, foam, and dry chemical or
zirconium fires

VIII. STORAGE OF CORROSIVES:

1. Store caustic and corrosive materials near the floor to minimize danger of bottles falling from
shelves.

2. Separate containers to facilitate handling.

3. Store organic acids (acetic acid and acetic anhydride) separately from strong oxidizing agents
(sulfuric, nitric, or perchlorate) to prevent interaction of fumes and corrosion of storage cabinets.

4. Bottle carriers must be used for containers of acid over 500 mL in size.

IX. STORAGE OF FLAMMABLES:

1. An approved flammable storage cabinet is required. Do not store more than 37 liters of
flammable liquid in an individual fire area. Not more than 227 liters are allowed in a flammable
storage cabinet unless approved by [Health Safety Officer or Lab Manager].

2. Quantities of 3.5 liters or larger must be stored in approved flammable material storage cabinets.
If a reagent must be stored in glass for purity, the glass container may be placed in a bottle to
lessen the danger of breakage.

3. Small quantities (working amounts) may be stored on open shelves, but bulk storage (more than
18 liters) must be in a flammable liquid storage room.

4. Do not store flammables in areas exposed to direct sunlight.

5. Ether is a particular hazard; only small containers (one pint or less) should be used. Once
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Johns Hopkins University
Baltimore, MD USA

opened, containers must be stored in an explosion-proof enclosure (preferably a vented


flammable storage cabinet).

6. Storage of flammables in refrigerators shall be in approved flammable material refrigerators only.

7. Small amounts of residual ether may be disposed of by leaving the open container in an
explosion-proof fume hood.

X. HANDLING CAUSTIC MATERIALS:

1. If large quantities of acids or alkalis are being used, use a shield or barrier or work in a sink or
fume hood so breaks or spills can be controlled.
2. Wear aprons, gloves, and eye protection devices when handling highly corrosive materials.
3. Do not pipette by mouth.
4. Do not sniff reagents.

XI. DILUTION:

1. Use great care and add reagents SLOWLY.


2. Always add acid to water, NEVER water to acid.
3. Allow acid to run down the side of the container and mix slowly by gentle rotation.
4. Avoid overheating.

XII. BREAKS AND SPILLS:

1. Skin/eye/mouth contact: wash area immediately & seek medical attention.


2. Clothing spills: take item of clothing off immediately to avoid soaking through to skin. This
includes belts and shoes (if affected). Rinse the affected area in the safety shower and seek
medical attention.

3. Refer to the MSDS to determine appropriate clean-up procedures using the following information:

• Type of material
• Identification - common or chemical name
• Volume of spill
• Degree of danger to others and property

4. Contain spills to prevent the spread of spilled material using any action designed for this
purpose. Evacuate area if irritating odors or dangerous vapors exist.

5. Clean up spill with sand or absorbent materials if it consists of acid, base or flammables. Wash
area thoroughly after clean up.

6. Toxic or explosive material spills shall be handled by [indicate personnel/department]. Notify


them of the spill at [number] and evacuate the area.

7. Large flammable spills, beyond the ability to handle safely, shall be handled by [indicate
personnel/department]. Notify them of the spill at [number] and evacuate the area.

8. Small quantities of miscible liquids may be flushed down the sink with copious amounts of water.

9. If exposure to a hazardous chemical has occurred, the employee shall report promptly to the
Occupational Injury Clinic or to the Adult Emergency Room when the clinic is closed. A Report of
Incident form is to be completed by the individual’s supervisor – see appendix 2.1.

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SMILE
Johns Hopkins University
Baltimore, MD USA

XIII. MERCURY:

1. Mercury Spills –

• Minimize mercury spills by using appropriate substitutes whenever possible.


• Evacuate the spill area. Ensure than none of the evacuated personnel has mercury
contaminated clothing
• Turn down the temperature. The cooler the temperature, the less mercury will vapors will be
released in the air. Vapors are colorless and odorless. However, if the ventilation or air
conditioning system vents to other areas, it must be turned off!
• Close interior doors.
• Report the spill if required by local regulations

2. Spills less than 3 mL’s

• Contain spills by surrounding contaminated area with wet paper towels. Surround or block off
the mercury to keep it from spreading onto sloped or porous surfaces. Divert all mercury
away from floor drains, cracks, or crevices that may impact groundwater, surface water, and
soils.

• Wear appropriate PPE: lab coat, gloves, goggles & mask (gas-mask, if available). Remove
all jewelry to prevent amalgamation.

• Assemble cleaning supplies:

Required Optional
a. Eye dropper or disposable pipette h. Sulfur – Yellow powder that forms
b. Flashlight mercuric sulfide upon contact and
c. Plastic container with lid turns brown.
d. Bio-hazard bag with re-sealable closure i. Powdered Zinc – amalgamates
e. Paper-towels with mercury to form a solid.
f. Rubber Squeegee j. Sodium Sulfide Solution
g. Plastic dust pan or rigid paper (index card) k. Acetic Acid
l. Hydrogen Peroxide

• Do not use a broom to pool droplets as this creates dust and smaller particles.
• Using the eyedropper or disposable pipette, pick up all visual mercury droplets.
• With the aid of a flashlight or other high intensity light, clean-up any remaining mercury with
the paper-towel or squeegee and dust-pan.
• If available, dust the area with sulfur or zinc powder to identify and clean any remaining
mercury.
• The presence of scattered mercury droplets may also be detected by a sodium sulfide
solution. This solution may be sprayed on an affected person (but NOT the eyes, mucous
membranes, or the mouth). Any mercury present will show up as dark, reddish brown stains.
Residual mercury may then be uplifted by wiping the area with a acetic acid-soaked swab,
followed by a peroxide wipe.
• Place all mercury contaminated items in a primary plastic container. Seal closed. Place the
primary plastic container into a secondary biohazard bag and seal closed. All materials that
come in contact with the mercury must be disposed of in this fashion.
• Mark the hazardous waste as: Elemental Mercury – Hazardous Waste.
• Do dispose of in accordance with local safety regulations. Contact [indicate
personnel/department] for disposal.

3. Large Mercury Spills - Mercury spills shall be handled by [indicate personnel/department]. Notify
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Johns Hopkins University
Baltimore, MD USA

them of the spill at [number] and evacuate the area.

4. Chronic exposure and absorption of mercury may lead to a metallic taste in the mouth, a "lead
line" (grey line) around gums, and neurological problems (irritable, hyper-reflexic, comatose).
Seek medical attention.

XIV. DISPOSAL OF HAZARDOUS MATERIALS

1. Excess hazardous material must be disposed of in accordance with local regulations. Unwanted
chemicals must be disposed through [indicate chemical disposal process]

2. Materials in any of the following categories must be disposed of as hazardous materials:

• Ignitable - any substance with a flash point below 60 ° C (140 ° F)

• Corrosive - any substance with pH of less than or equal to 2.0 or greater than or equal to
12.5.

• Reactive - any substance which is unstable, reacts violently with water, forms potentially
explosive mixtures with water, generates toxic gases, vapors or fumes when mixed with
water or exposed to a pH between 2.0 and 12.5, or capable of detonation or explosive
decomposition or reaction.

• Toxic - any substance which contains any of the compounds listed by the EPA under the
Resource Conservation and Recovery Act at or greater than the listed concentration.

• Specific chemicals - any substance containing an EPA listed compound.

3. Chemicals must be properly identified before proper disposal. “Unknown” materials cannot be
disposed until they have been properly characterized with appropriate documentation.

4. [Indicate any special disposal procedures, contacts or phone numbers].

XV. CARCINOGENS - Specific regulations have been established by OSHA regarding the handling of certain
compounds designated as carcinogenic. An inventory of all such materials must be maintained and
specific protective measures observed.

1. Substances confirmed by OSHA to be carcinogenic to humans and require special precautions:

4-Aminodiphenyl, Skin bis(Chloromethyl) ether


4-Nitrodiphenyl, skin Chromite ore processing (chromate)
β-Naphthylamine Coal tar pitch volatiles as benzene solubles
Arsenic, elemental and inorganic insoluble and water-soluble CrVi compounds,
compounds (except Arsine) NDC
Asbestos (all forms) Nickel, insoluble and soluble compounds
Benzidine, Skin Vinyl chloride
Benzene - skin zinc chromates

2. Suspected human carcinogens:

1,1 - Dimethylhydrazine, Skin Chlormethyl methyl ether Methulene chloride


1,3 - Butadiene Chloroform Methyl hydrazine, Skin
1,4 - Dichloro - 2 - butene, skin Chrysene Methyl iodide, Skin
2-Nitropropane Dichloromethane N-Nitrosodimethylamine,
Skin
Fac1.0-13 Appendix 6-Chemical Safety Version#: 2.0 Page 12 of 13
SMILE
Johns Hopkins University
Baltimore, MD USA

3,3' - Dichlorobenzidine, Skin Dimethyl sulfate, Skin N-Phenyl-beta-naphthyl-


amine
4 - vinul cyclohexene Dimethylcarbamoyl chloride O-Toluidine, Skin
4,4' - Methylene bis (2- Dinitrotoluene p-Toluidine, Skin
chloroaniline)
4,4' - Methylene dianiline, Skin Epichlorohydrin Phenylenediamine
β-Propiolactone Ethul achylate Phenylhydrazine, Skin
Acrylamide - Skin Ethul bromide, skin Propane sultone
Acrylonitrile, Skin Ethulene dibromide, skin Propyleneimine, Skin
Antimony Trioxide production Ethylene oxide Strontium chromate
Benz [a] anthracene Formaldehyde Tetranitromethane
Benz [b] fluoranthene Hexachlorobutadiene, Skin Vinyl bromide
Benzo(a)pyrene Hexachloroethane, skin Vinyl chclohexene dioxide,
Skin
Beryllium and compounds Hexamethyl phosphoramide, xylicline (mixed isomers),
Skin skin
Cadmium elemental and Hydrazine, Skin Zinc chromate
compounds, as cd.
Calcium chromate Lead chromate as Cr and Pb

3. The above list of carcinogens is extracted from the lists provided by Chemical Threshold Limit
Values Committee of the American Conference of Governmental Industrial Hygienist's. If your
laboratory has any of the above substances, please check with "Right To Know" list for specific
recommendations on how to deal with any emergencies.

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SMILE
Johns Hopkins University
Baltimore, MD USA

Appendix 7 – Waste Management SOP

Author: Document Number: Fac10-13 App 7


Jo Shim Effective (or Post) Date: 17-Feb-09
Review History Date of last review: 26-Jan-12
Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

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SMILE
Johns Hopkins University
Baltimore, MD USA

Appendix 7 – Waste Management SOP

Jo Shim MBA, MT (ASCP) Document Number Effective Date


Author(s), Name &
Title Fac10-13-SOP 17 Feb 2009
International QA/QC Coordinator
Appendix 7
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when
considering their use in other applications. If you have any questions contact SMILE.

Name, Title Signature Date


Approved By

Name, Title Signature Date

SOP Annual
Review

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]
Revision
History 2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template
format requirements.

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

Fac1.0-13 Appendix 7-Waste Management Version#: 2.0 Page 2 of 7


SMILE
Johns Hopkins University
Baltimore, MD USA

I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

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SMILE
Johns Hopkins University
Baltimore, MD USA

APPENDIX 7 – WASTE MANAGEMENT

1. Safety Precautions

• Follow standard precautions as outlined in SOP [Enter reference information for


your lab’s Safety SOP]

• Do not push or pack regulated waste except in compactors that are specifically
designed for medical waste.

• Use clearly marked containers for each type of waste as noted in this SOP to ensure
optimal safety.

• Locate containers in the immediate area of use.

• Wear proper personnel protective equipment appropriate to the task when handling
any regulated waste, including water resistant gloves.

• Wash hands immediately after removing gloves.

2. Definitions

Segregation– The initial and crucial point in the waste handling process that will
help determine the amount and type of waste generated in the laboratory. [Your lab]
has designated waste as follows:

• Non-Hazardous - unregulated and does not present special concerns for


containment or handling. This waste can be discarded in normal domestic garbage
and will comply with local regulatory guidance for purposes of waste reduction and
recycling. Uncontaminated trash and paper can be disposed of in the general trash.
Unless there is evidence of contamination with blood, urine may be disposed through
the sewage system. Use caution to prevent splatter. The empty container must be
disposed in the biohazardous containers.

• Biohazardous – This is regulated waste and will include infectious and biological
waste. Procedures for handling, containment, storage and transport will be covered
in this SOP. Specimens contaminated with blood will be disposed of in red biohazard
bags or placed in buckets lined with autoclavable biohazard bags for autoclaving
prior to disposal. Other body fluid, solid and semi-solid waste including laboratory
supplies (e.g. microbiological cultures) and contaminated urine should be placed in
containers or buckets lined with autoclavable biohazard bags, and sent to [your
designated area] to be autoclaved prior to disposal. The fill level must be ¼ below
the rim of the container. Specimen transport bags bearing the biohazard sign and
gloves should be discarded in red bag trash.

• Sharps – This is regulated waste and will include needles, scalpel blades, glass
ampoules, broken glass, lancets, etc. Sharps waste may or may not be
biohazardous. Procedures for handling, containment, storage and transport will be
covered in this SOP.

• Chemical – Chemical waste is regulated waste and must not be disposed of in the
biohazardous or sharps waste containers. It will be segregated and disposed of
based on ignitability, corrosivity, reactivity and toxicity. Refer to the chemical safety
SOP for further guidance on safe handling and disposal processes.
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Johns Hopkins University
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• Radioactive – This is a regulated waste and is currently not generated in [your lab].
For questions regarding radioactive waste disposal, refer to the safety officer (enter
name or contact information for your safety officer if appropriate).

3. Sharps Disposal

• Dispose of sharps in rigid plastic puncture resistant sharps containers, marked with
the universal biohazard symbol, immediately after use. Polystyrene, non-rigid plastic,
paper and cardboard containers are not acceptable.

• Items considered sharps are: needles, syringes, slides, glass pipettes, glass capillary
tubes, scalpels and knives. Substitute plasticware for glassware whenever possible.

• A larger size of sharps container e.g. the ten quart size is used for discarding higher
volumes of sharps, including pasteur pipettes and larger-sized sharps.

• The container lids are to be left open until the containers are ready for disposal.
When discarded sharps reach the fill level designated on the container (at the
constriction or line), close the lid opening and clip it into place. Secure the lid in the
closed position with tape.

• Laboratory staff will transport containers to the secure biohazardous waste storage
site where they will be pick-up once or twice per week as disposed of by [your waste
removal company].

• Proper transport & disposal paper work will accompany all waste pick-ups in
accordance with local regulatory guidelines

• Do not discard sharps waste in the biohazardous waste containers nor in the
unregulated waste and do not discard unregulated waste in the sharps containers.
Segregate as directed.

4. Biohazard Container

• Dispose of pipettes, autoclaved waste material, blood tubes, material soiled with
potentially infectious agents, blood, tissue, body fluids and any materials which may
be perceived to be "special medical waste", such as calibrated plastic centrifuge
tubes, conical tubes and pipettes in durable reusable containers lined with approved
red plastic bags that are impervious to moisture, puncture resistant, and displays the
universal biohazard symbol.

• Fill the waste containers to not more than ¾ full.

• Seal closed with autoclave tape and autoclave waste in accordance with the
Autoclave operation SOP.

• Clean and decontaminated storage containers with approved disinfectant each time
they are emptied. Do not reuse cardboard boxes.

• Do not discard unregulated waste in the biohazardous waste containers.

• Biohazard waste will be disposed of through incineration at the [your incineration


site].

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• Waste will be removed through a contracted carrier once or twice weekly depending
upon accumulation.

• Proper transport & disposal paper work will accompany waste in accordance with
local regulatory guidelines.

• Notify the incineration site of all shipments prior to transport.

5. Glass Disposal

• All glass items that are contaminated by known infectious agents, blood or body
fluids requiring Standard Precautions is regulated waste and shall be disposed of in
an approved sharps container or the approved Biohazard Box.

• All laboratory glassware with a potential to be perceived as medical waste (e.g. items
with graduated markings) is considered regulated waste and is to be discarded in the
approved sharps container or the approved Biohazard Box whether “clean” or
contaminated.

• All glass containers not containing a hazardous chemical and not contaminated by
blood, body fluids or infectious agents is considered unregulated waste may be
drained and discarded in appropriately marked “Glass Only” refuse containers.
Cardboard containers can be sealed when full and disposed of in the general trash.

6. Storage

• Store waste in [designated location] with limited access.

• The storage room floor must be impervious to liquid and have sufficient ventilation to
control odors.

• Keep storage area clean to keep vermin and other vectors away.

• Area will be posted prominently with the universal biohazard symbol.

• Minimize regulated waste storage time. Do not exceed 7 days.

• Do not expose storage waste to moisture, heat or weather.

7. Transportation

• Containers used to transport regulated waste should be leak proof.

• Display the universal biohazard symbol prominently on regulated waste transport


containers.

• Select transport routes within the healthcare facility that minimize the risk of
exposure to patients, staff and visitors.

• Do not use mechanical devices to handle, transfer or load regulated waste


containers due to the risk of rupture and spillage.

• Keep personnel protective equipment and disinfectant available during transport.


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8. Record Keeping - Maintain records of regulated waste disposal. Records should include
the following:

• Name of generating site


• Name of individual transporting waste
• Phone number and contact person at generated site
• Number of bags and or boxes transported
• Time of departure from generated site
• Time of arrival at incineration site
• Name of incineration site
• Phone number and contact person at incineration site
• Name of person receiving regulated waste

References

1. NCCLS. Clinical Laboratory Waste Management; Approved Guideline—Second Edition. NCCLS


document GP5-A2 (ISBN 1-56238-457-0). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898, USA 2002.
2. Clinical Laboratory Standards Institute (CLSI). Clinical Laboratory Technical Procedure Manuals; Fourth
Edition. CLSI Document GP2-A4 (ISBN 1-56238-458-9). Clinical and Laboratory Standards Institute,
Wayne, PA
3. Patient Safety Monitoring in International Laboratories (SMILE). Waste Disposal SOP: JHU, Baltimore,
Maryland

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