general lab safety policy - guidelines

SMILE Johns Hopkins University

Baltimore, MD USA

Fac1.0-13 General Lab Safety Version#: 2.0 of 16

General Lab Safety Policy - Guidelines

Author: Penny Stevens

Document Number: Fac10-13

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.


Baltimore, MD USA


General Lab Safety Policy - Guidelines General Lab Safety Guideline Number Fac10-13-G

Effective Date 17 February 2009

Subject

General Laboratory Safety Guidelines

Page 1 of 2

Supersedes Fac10-13 v1.0


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.


Baltimore, MD USA


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).


Baltimore, MD USA


General Lab Safety - SOP Author(s), Name & Title

Penny S. Stevens Document Number

Effective Date

Sr. Int’l QA/QC Coordinator Fac10-13-SOP 17 Feb 2009


Approved By

Name, Title Signature Date

SOP Annual Review


Revision History

Version # [0.0] Revision Date [dd/mm/yy]

Description (notes)

2.0 17 Feb 2009 Reformatted to meet SMILE Resource Template format requirements.

Distributed Copies to

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


Baltimore, MD USA


I acknowledge that I have read, understand and agree to follow this SOP.

Name (print) Signature Date


Baltimore, MD USA


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


Baltimore, MD USA


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 Services

Occupational Health

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.


Baltimore, MD USA


• 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].


Baltimore, MD USA


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.


Baltimore, MD USA


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.


Baltimore, MD USA


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.


Baltimore, MD USA


• 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.


Baltimore, MD USA


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.


Baltimore, MD USA


• 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,


Baltimore, MD USA


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:





Baltimore, MD USA














Baltimore, MD USA

Fac1.0-13 Appendix 1-Standard Precautions Version#: 2.0 Page 1 of 8

Appendix 1 - Standard Precautions SOP


Document Number: Fac10-13 App1

Effective (or Post) Date: 17 Feb 2009





Baltimore, MD USA


Appendix 1 - Standard Precautions SOP Author(s), Name & Title

Penny S. Stevens Document Number

Effective Date

Sr. Int’l QA/QC Coordinator Fac10-13-SOP Appendix 1

17 Feb 2009


Approved By


Jo Shim MBA, MT(ASCP)

SOP Annual Review


Revision History


Description (notes)





Baltimore, MD USA





Baltimore, MD USA


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


Baltimore, MD USA


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


Baltimore, MD USA


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.


Baltimore, MD USA


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






Baltimore, MD USA












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.


Baltimore, MD USA

Fac10-13_App2_Lab_Accidents.doc Version 2.0 Page 1 of 9

Appendix 2 – Laboratory Accident SOP


Document Number: Fac10-13 App 2

Effective (or Post) Date: 17-Feb-09





Baltimore, MD USA


Appendix 2 – Laboratory Accident SOP

Author(s), Name & Title

Penny S. Stevens MBS, MT (ASCP), CLS (NCA)

Document Number Effective Date

International QA/QC Coordinator Fac10-13-SOP Appendix 2

17 Feb 2009


Approved By



SOP Annual

Review


Revision History


Description (notes)





Baltimore, MD USA





Baltimore, MD USA


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:


Baltimore, MD USA


• 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.


Baltimore, MD USA


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









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.


Baltimore, MD USA


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:


Baltimore, MD USA


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.)


Baltimore, MD USA


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


Baltimore, MD USA

Fac10-13_App3_Fire_Safety .doc Version #: 2.0 Page 1 of 10

Appendix 3 – Fire Safety SOP Author: Jo Shim







Baltimore, MD USA


Appendix 3 – Fire Safety SOP


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


17 Feb 2009


Approved By


SOP Annual

Review


Revision History


Description (notes)





Baltimore, MD USA





Baltimore, MD USA


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


Baltimore, MD USA


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


Baltimore, MD USA


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.


Baltimore, MD USA


• 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, Standard -

Useful on Class B and C fires. Leaves a mildly corrosive residue which must be cleaned up immediately to prevent damage to electrical equipment. Best uses are automotive, grease fires and flammable liquids.

b. Dry Chemical, Multipurpose

Useful for Class A, B, and C fires. Versatile and effective on most common types of fires. Highly corrosive and leaves a sticky residue. Not for use around delicate electrical appliances or computers.

c. Halogenated Agents

Useful on Class A, B, and C fires (depending on agent used, check 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 Agent

Use on Class A fires only. Inexpensive to refill and maintain.


Baltimore, MD USA


• 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.


Baltimore, MD USA


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


Baltimore, MD USA


Appendix 3.2 - Example of an Evacuation Plan


Baltimore, MD USA

Fac10-13_App4_BioSafety.doc Version 2.0 Page 1 of 10

Appendix 4 – Biosafety SOP Author: Penny Stevens

Document Number: Fac10-13-App 4






Baltimore, MD USA


Appendix 4 – Biosafety SOP





17 Feb 2009


Approved By


SOP Annual

Review


Revision History


Description (notes)





Baltimore, MD USA





Baltimore, MD USA


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.


Baltimore, MD USA


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.


Baltimore, MD USA


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)


Baltimore, MD USA


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


Baltimore, MD USA


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

BSL Agents Practices Safety Equipment (Primary Barriers)

Facilities (Secondary Barriers)

1

Not known to consistently

cause disease in healthy adults

Standard Microbiological

practices

Lab coats, gowns or uniforms Gloves, protective

eyewear where potential splashes anticipated

Open bench top & sink required

2

Associated with human disease.

Hazards are percutaneous.

Injury, ingestion, & mucous membrane exposure

BSL-1 plus limited access

Biohazard warning signs.

Sharps precautions, &

biosafety manual

Primary barriers: BSC or physical containment devices used for all

manipulations of agents that cause splashes or aerosols of infectious

materials. PPE’s: lab coats, gloves, & face protection as

needed

BSL-1 plus: Autoclave available


Baltimore, MD USA


3

Indigenous or exotic agents

with potential for aerosol

transmission. Disease may

have serious or lethal

consequences.

BSL-2 plus: controlled access,

decontamination of all waste,

decontamination of lab clothing

before laundering, &

baseline serum tests

Primary barriers: BSC or other physical containment devices used for all open manipulations of agents.

Standard PPE plus: additional protective lab clothing and respiratory protection as needed

BSL1 &2 plus: Physical separation from access corridors ,Self-closing double door access, exhausted air not re-

circulated and negative airflow lab

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.


Baltimore, MD USA


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




4. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory Accreditation Program; Microbiology Checklist Revised 9/27/2007.










Baltimore, MD USA

Fac10-13_App5_Elect_&_Mech_Safety.doc Version 2.0 Page 1 of 11

Appendix 5 – Electrical and Mechanical Safety SOP








Baltimore, MD USA


Appendix 5 – Electrical and Mechanical Safety SOP





17 Feb 2009


Approved By



SOP Annual

Review


Revision History


Description (notes)





Baltimore, MD USA





Baltimore, MD USA


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.


Baltimore, MD USA


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.)


Baltimore, MD USA


• 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 –196oC. Very small amounts of liquid vaporize into large amounts of gas. One liter of liquid nitrogen becomes 0.7 m3 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.


Baltimore, MD USA


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.


Baltimore, MD USA


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




4. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory Accreditation Program; Microbiology Checklist Revised 9/27/2007.










Baltimore, MD USA


APPENDIX 5.1

Laboratory Name Emergency Equipment Maintenance Log

Month/Year Department:

Equipment Type: (Eye Wash, Drench hose,

shower, etc.)

Inventory Number:

Emergency Equipment was run for at least 3 minutes and until

water was sediment free

Eye wash caps cleaned with 70% alcohol solution

Comes on within one second of activation:

Water feels tepid to the

touch:

Water pressure is adequate based

on visual and touch inspection:

Eye wash caps

present and functional:

Annual Service

Due:

Corrective Action

Tech Initials & Date

Equipment Type: (Fire blanket, extinguisher,

alarm, etc.)

Inventory Number:

Equipment present and easily accessible:

Equipment servicable:

Expiration date valid:

Fire alarm test

performed:

Fire Extinguisher is properly mounted, serviced & charged:

Annual Service

Due: Corrective Action Tech Initials &

Date

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.


Baltimore, MD USA


Appendix 5.2

Laboratory Name Internal Safety Audit Checklist

General Fire Safety Yes No N/A

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.

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

Auditor: Date: Supervisor: Date: Comments

Page 1 of 2


Baltimore, MD USA


Laboratory Name Internal Safety Audit - Corrective Actions

Item number Finding Corrective Action

Anticipated Completion

Date

Auditor: Date: Supervisor Review: Date: Comments:

Pg 2 of 2


Baltimore, MD USA

Fac1.0-13 Appendix 6-Chemical Safety Version#: 2.0 Page 1 of 13

Appendix 6 – Chemical Safety SOP Author: Jo Shim







Baltimore, MD USA


Appendix 6 – Chemical Safety SOP




17 Feb 2009


Approved By


SOP Annual

Review


Revision History


Description (notes)





Baltimore, MD USA





Baltimore, MD USA


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.


Baltimore, MD USA


• 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.


Baltimore, MD USA


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


Baltimore, MD USA


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)

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

http://www.ilpi.com/msds/ref/oxidation.html

http://www.ilpi.com/msds/ref/chemical.html

http://www.ilpi.com/msds/ref/combustible.html

http://www.ilpi.com/msds/ref/waterreactive.html

http://www.ilpi.com/msds/ref/acid.html

http://www.ilpi.com/msds/ref/corrosive.html

http://www.ilpi.com/msds/ref/ph.html

http://www.ilpi.com/msds/ref/base.html

http://www.ilpi.com/msds/ref/ph.html



http://www.ilpi.com/msds/ref/poison.html

http://www.ilpi.com/msds/ref/highlytoxic.html

http://www.ilpi.com/msds/ref/chip.html

http://www.ilpi.com/msds/ref/inhalation.html


Baltimore, MD USA


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

VII. INCOMPATIBLE CHEMICALS

Chemical Incompatible with:

Alkaline and alkaline earth metals, such as sodium, potassium, cesium, lithium, magnesium, calcium, aluminum

Carbon dioxide, carbon tetra-chloride, and other chlorinated hydrocarbons, any free acid or halogen. Do not use water, foam, or dry chemical on fires involving these metals.

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 (hydrogen fluoride)

Ammonia, aqueous or anhydrous

Hydrogen sulfide Fuming nitric acid, oxidizing gases Hydrocarbons (benzene, butane, propane, gasoline, turpentine)

Fluroine, chlorine, bromine, chromic acid, sodium peroxide

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

http://www.ilpi.com/msds/ref/explosive.html


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 or antioxidants

Acetic anhydride, bismuth and its alloys, alcohol, paper, wood, 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


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.


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

mercuric sulfide upon contact and turns brown.

b. Flashlight c. Plastic container with lid d. Bio-hazard bag with re-sealable closure i. Powdered Zinc – amalgamates

with mercury to form a solid. e. Paper-towels 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


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 compounds (except Arsine)

insoluble and water-soluble CrVi compounds, 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


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-chloroaniline)

Dinitrotoluene p-Toluidine, Skin

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,

Skin xylicline (mixed isomers), skin

Cadmium elemental and compounds, as cd.

Hydrazine, Skin Zinc chromate

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.


Baltimore, MD USA

Fac1.0-13 Appendix 7-Waste Management Version#: 2.0 Page 1 of 7

Appendix 7 – Waste Management SOP

Author: Jo Shim







Baltimore, MD USA


Appendix 7 – Waste Management SOP




17 Feb 2009


Approved By


SOP Annual

Review


Revision History


Description (notes)





Baltimore, MD USA





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.


Baltimore, MD USA


• 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].


Baltimore, MD USA


• 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.


Baltimore, MD USA


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.


3. Patient Safety Monitoring in International Laboratories (SMILE). Waste Disposal SOP: JHU, Baltimore, Maryland

general lab safety policy - guidelines

Documents