CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:
Safety
Author: Penny S. Stevens / Document Number: / Pro71-10Effective Date: / 21 August 2009
Review History / Date of last review: / 20 May 2010
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.
Element
Present / Content-Specific Required Elements
PERSONNEL
Describe importance of hand washing, proper technique, laboratory facilities and products available (e.g., sink locations, soap, disposable towels, etc.).
Describe the laboratory dress code (e.g., no lose or skimpy clothing, closed toes and non-cloth shoes, legs should not be exposed above the knee, etc.).
Describe Personal Protection Equipment (PPE) guidelines and availability (e.g., lab coats or gowns, gloves, goggles, face shields, etc.).
Comments:
PERSONNEL HEALTH
Describe any vaccinations and health screenings offered to laboratory personnel (e.g., TB skin tests, health physical, Hepatitis B vaccinations, etc.).
Describe the laboratory written exposure and injury plan (e.g., post exposure or injury notification, counseling, documentation, medical services, follow-up, etc.) and where the plan is posted for easy access.
Describe the location(s) first aid available to personnel in or near the laboratory (e.g., eye wash stations, first aid stations, etc.)
Comments:
STANDARD PRECAUTIONS
All emergency numbers are clearly posted in several locations throughout the lab.
Describe the laboratory policy for lab coat cleaning.
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h.) / Describe all applicable Standard Laboratory Precautions for the laboratory
a.) Food and beverages must be stored in specially identified refrigerators/freezers away from where biological specimens are stored.
b.) Eating, drinking, chewing gum, cosmetic application and contact lens handling are not permitted in the lab.
c.) Long hair must be tied back while working near flames and equipment.
d.) Always use appropriate PPE for the task being conducted.
e.) Never pipette by mouth.
f.) Never smoke in the lab. Smoking permitted only in designated areas.
g.) If splashing is possible, task should be performed in Biological Safety Cabinet (or hood).
h.) Containers should be opened in such a way as to reduce the production of aerosols.
Entry of all non-laboratory or maintenance personnel is restricted to assure that all visitors can be advised of the potential biohazards.
For Biosafety Level 3 Laboratories: Entry and exit procedures are posted.
Comments:
WASTE MANAGEMENT
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d.) / Describe the laboratory policy on basic waste management safety.
a.) Use clearly marked containers for each type of waste as described in laboratory procedures. Ensure that waste containers are specific for medical waste.
b.) Containers should be located in the immediate area of use.
c.) Wear proper PPE when handling regulated waste.
d.) Wash hands immediately after handling waste.
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d.) / Describe the laboratory policy on sharps disposal.
a.) Define items considered sharps.
b.) Use rigid plastic puncture resistant container labeled with the universal biohazard symbol.
c.) Containers lids to be left open until ready for disposal.
d.) Segregate waste as directed (e.g., not with biohazardous or unregulated waste containers, etc.).
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g.) / Describe the laboratory policy on biohazard disposal.
a.) Define items that need to be disposed as biohazardous waste.
b.) Use approved red plastic bags that are impervious to moisture, puncture resistant, and displays the universal biohazard symbol.
c.) Fill containers no more than ¾ full.
d.) Seal with autoclave tape and autoclave in accordance with lab procedures.
e.) Clean and decontaminate storage containers in accordance with lab procedures each time they are emptied.
f.) Do not discard unregulated waste in the biohazardous waste container.
g.) Proper transport and disposal paperwork will accompany waste in accordance with laboratory procedures and in compliance with local guidelines.
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c.) / Describe the laboratory policy on glass disposal.
a.) All glass items that are contaminated with infectious agents, blood or body fluid requiring standard precautions shall be disposed of in an approved sharps container.
b.) All laboratory glassware with potential to be perceived as medical waste shall be discarded in an approved sharps container.
c.) Any glass container not containing hazardous chemicals, not contaminated by blood, body fluids, or infectious agents is considered unregulated and can be discarded in an appropriate container marked, “Glass Only,” to be disposed of with general trash.
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e.) / Describe the laboratory policy on waste storage.
a.) Define a location with limited access where waste will be stored.
b.) Keep storage area clean.
c.) Prominently post a universal biohazard symbol.
d.) Minimize regulated waste storage time (e.g., do not exceed 7 days).
e.) Do not expose stored waste to moisture, heat or weather.
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c.) / Describe the laboratory policy on waste transport.
a.) Containers used to transport regulated waste should be leak proof and prominently display the universal biohazard symbol.
b.) Transport waste so to minimize the risk of exposure to patients, staff, and visitors.
c.) Use appropriate PPE and keep disinfectant available during transport.
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h.) / Describe the laboratory policy on maintaining records of regulated waste disposal. Records should include:
a.) Name of waste-generating site.
b.) Name of company/individual transporting waste.
c.) Phone number and contact person at generating site.
d.) Number of containers, bags, boxes, etc., transported.
e.) Time of departure from generated site.
f.) Time of arrival at incineration site.
g.) Name of incineration site with phone number and contact name, if different from generating site.
h.) Name of personnel receiving regulated waste.
Comments:
REUSABLE ITEM STERILIZATION
All reusable items of metal, glass, or heat-resistant plastic will be sterilized by steam heat in an autoclave.
Non-heat-resistant items will be decontaminated in accordance to lab procedure (e.g., soaking in iodine or hypochlorite solution for 6 hours and then rinsed).
Comments:
DISENFECTING WORK SURFACES
Describe daily disinfecting policy. Include what type (concentration) of cleaner used, what areas and instruments are cleaned, etc.
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i.) / Describe the laboratory policy disinfecting body fluid spills and grossly contaminated surfaces. Include the following in the policy:
a.) Notify all personnel in the immediate work area.
b.) Put on necessary PPE.
c.) Contain large spills by surrounding the area with absorbent material.
d.) Saturate area with appropriate disinfectant as per lab procedure.
e.) Cover the spill with absorbent materials.
f.) Allow the disinfectant to penetrate for a minimum of 10 minutes.
g.) Use forceps, tongs, etc. to clean up broken glass or sharp objects if present.
h.) Discard the contaminated materials in an appropriate medical waste container depending on the nature of the material.
i.) Perform final wipe with fresh disinfectant and let dry.
Comments:
CENTRIFUGATION - AEROSOLIZATION
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c.) / Describe the laboratory policy on centrifugation to reduce the production of aerosols:
a.) Centrifuge in a closed system.
b.) Always use the safety-interlock feature to prevent opening the unit while still in motion.
c.) Centrifuges used with potentially biohazardous material are disinfected weekly with proper disinfectant (e.g., hypochlorite solution).
Comments:
FLAMMABLE/COMBUSTIBLE LIQUIDS
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c.) / Describe the laboratory policy on storage of flammable liquids:
a.) Flammable liquids will not be stored outside an approved storage cabinet for more than 5 working days.
b.) All flammable liquid containers will be stored in approved flamable liquid cabinet or approved storage rooms. The total capacity will not exceed 60 gallons (227.1L).
c.) No flammable liquids will be stored in a refrigerator unless it is an approved Flammable Materials Storage Refrigerator.
Comments:
COMPRESSED GAS CYLINDERS
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c.) / Describe the laboratory policy on compressed gas cylinders:
a.) All compressed gas cylinders, either in use or storage, shall be secured upright by a strap or a chain.
b.) All cylinders, lines and equipment used with flammable compressed gases shall be grounded and stored in separate from oxidizing gases (e.g., oxygen).
c.) A suitable hand truck will be used to transport gas cylinders.
Comments:
CHEMICAL HAZARDS
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d.) / Describe the laboratory policy for chemical hazards.
a.) Material Safety Data Sheets (MSDS) for all chemicals used in the lab must be readily accessible to all personnel.
b.) Label containers of chemicals properly (manufacturer’s labels are acceptable).
c.) Train personnel to recognize potential hazards in the workplace and proper procedures for handling hazardous substances.
d.) Prepare a list of potentially hazardous chemical used in the lab. Review and update this list at least annually.
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d.) / If the laboratory uses the following substances, include the policy for usage, storage and disposal of the following substances:
a.) Liquid nitrogen
b.) Dry ice
c.) Radioisotopes
d.) Carcinogens
Comments:
SAFETY REPORTING
Describe the laboratory policy on employees reporting safety hazards. This should be done in verbally or in writing without fear of repercussions.
Employees will be advised of all safety report findings at least monthly.
Comments:
TRAINING AND EDUCATION
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h.) / Describe the laboratory policy on safety training of new employees. The training program should cover the following topics:
a.) Fire Emergency Plan (how to report fires, when to pull alarm, important phone numbers, locations of fire exits, evacuations routes, meeting place, etc.).
b.) Electrical and Mechanical Safety (instrument grounding, shocks, UV light precautions, etc).
c.) Flammable Liquid Policy (use, storage, and maximum amounts that can be stored).
d.) Compressed Gas (how to close/open vents, secure and move tanks, use of chains or strap, etc.).
e.) Decontamination (how to decontaminate infectious waste before disposal, autoclave/incinerator, types of containers to dispose sharps, biohazardous waste, glass, and general trash, etc.).
f.) Chemical Safety (MSDS location and use, explanation of biohazardous symbol, color codes and precautions, where chemicals are used and stored, etc.).
g.) Personal Safety (potential hazards, mode of disease transmission and prevention of blood borne pathogens, PPE use, storage, decontamination, corrective action when spills occur, personal exposure to body fluids or tissues, etc.).
h.) Emergency Equipment (how to operate emergency equipment and maintenance required – eyewash, shower, fire blankets and extinguishers, etc.)
Documentation of the initial safety training to be found in employees file.
Blood borne pathogens and fire safety training will be renewed yearly for all employees. Documentation of training to be updated in employee files.
Comments:
References:
· OSHA 29 CFR Part 1910.1200: Hazard Communication
· OSHA 29 CFR Part 1910.1450: Hazardous Chemicals in Laboratories
· OSHA 29 CFR Part 1910.1030: Bloodborne Pathogens Standard
· OSHA “Needlestick Safety and Prevention Act”
· Federal Register, Department of Transportation, 49 CFR Parts 171, 172, 173, 177, and 178: Hazardous Materials: Revision to Standards for Infectious Substances: Final Rule
· 39 CFR Part 111: Hazardous Materials: Proposed Domestic Mail Manual Revisions for Division 6.2 Infectious Substances and Other Related Changes
· Clinical Laboratory Improvement Amendment (CLIA) Self-Assessment Questionnaire
· College of American Pathologists (CAP), Laboratory General Checklist for Laboratory Accreditation Program
· ICH E6 Good Clinical Practice: Consolidated Guidance (GCP)
· 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies (GLP)
· 42 CFR Part 493: Laboratory Requirements
SMILE Document Page 1 of 6 SOP Checklist - Safety