CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:



CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:

Safety

|Author: Penny S. Stevens |Document Number: |Pro71-10 |

| |Effective Date: |21 August 2009 |

|Review History |Date of last review: |3 April 3, 2020 |

| |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 |Content-Specific Required Elements |

|Present | |

|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. |

| |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. |

| |Long hair must be tied back while working near flames and equipment. |

|c.) |Always use appropriate PPE for the task being conducted. |

|d.) |Never pipette by mouth. |

|e.) |Never smoke in the lab. Smoking permitted only in designated areas. |

|f.) |If splashing is possible, task should be performed in Biological Safety Cabinet (or hood). |

|g.) |Containers should be opened in such a way as to reduce the production of aerosols. |

| | |

|h.) | |

| |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 |

| |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. |

| |Containers should be located in the immediate area of use. |

|b.) |Wear proper PPE when handling regulated waste. |

|c.) |Wash hands immediately after handling waste. |

|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. |

| |Containers lids to be left open until ready for disposal. |

|c.) |Segregate waste as directed (e.g., not with biohazardous or unregulated waste containers, etc.). |

|d.) | |

| |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. |

| |Do not discard unregulated waste in the biohazardous waste container. |

|f.) |Proper transport and disposal paperwork will accompany waste in accordance with laboratory procedures and in compliance with |

|g.) |local guidelines. |

| |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. |

| |All laboratory glassware with potential to be perceived as medical waste shall be discarded in an approved sharps container. |

|b.) |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 |

|c.) |trash. |

| |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. |

| |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. |

| |Transport waste so to minimize the risk of exposure to patients, staff, and visitors. |

|b.) |Use appropriate PPE and keep disinfectant available during transport. |

| | |

|c.) | |

| |Describe the laboratory policy on maintaining records of regulated waste disposal. Records should include: |

| |Name of waste-generating site. |

|a.) |Name of company/individual transporting waste. |

|b.) |Phone number and contact person at generating site. |

|c.) |Number of containers, bags, boxes, etc., transported. |

|d.) |Time of departure from generated site. |

|e.) |Time of arrival at incineration site. |

|f.) |Name of incineration site with phone number and contact name, if different from generating site. |

|g.) |Name of personnel receiving regulated waste. |

| | |

|h.) | |

|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. |

| |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. |

| |Perform final wipe with fresh disinfectant and let dry. |

|i.) | |

|Comments: |

|CENTRIFUGATION - AEROSOLIZATION |

| |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. |

| |Centrifuges used with potentially biohazardous material are disinfected weekly with proper disinfectant (e.g., hypochlorite |

|c.) |solution). |

|Comments: |

|FLAMMABLE/COMBUSTIBLE LIQUIDS |

| |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. |

| |All flammable liquid containers will be stored in approved flamable liquid cabinet or approved storage rooms. The total |

|b.) |capacity will not exceed 60 gallons (227.1L). |

| |No flammable liquids will be stored in a refrigerator unless it is an approved Flammable Materials Storage Refrigerator. |

|c.) | |

|Comments: |

|COMPRESSED GAS CYLINDERS |

| |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. |

| |All cylinders, lines and equipment used with flammable compressed gases shall be grounded and stored in separate from |

|b.) |oxidizing gases (e.g., oxygen). |

| |A suitable hand truck will be used to transport gas cylinders. |

|c.) | |

|Comments: |

|CHEMICAL HAZARDS |

| |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. |

| |Label containers of chemicals properly (manufacturer’s labels are acceptable). |

|b.) |Train personnel to recognize potential hazards in the workplace and proper procedures for handling hazardous substances. |

| |Prepare a list of potentially hazardous chemical used in the lab. Review and update this list at least annually. |

|c.) | |

| | |

|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 |

| |Describe the laboratory policy on safety training of new employees. The training program should cover the following topics: |

| |Fire Emergency Plan (how to report fires, when to pull alarm, important phone numbers, locations of fire exits, evacuations |

|a.) |routes, meeting place, etc.). |

| |Electrical and Mechanical Safety (instrument grounding, shocks, UV light precautions, etc). |

|b.) |Flammable Liquid Policy (use, storage, and maximum amounts that can be stored). |

| |Compressed Gas (how to close/open vents, secure and move tanks, use of chains or strap, etc.). |

|c.) |Decontamination (how to decontaminate infectious waste before disposal, autoclave/incinerator, types of containers to dispose |

|d.) |sharps, biohazardous waste, glass, and general trash, etc.). |

| |Chemical Safety (MSDS location and use, explanation of biohazardous symbol, color codes and precautions, where chemicals are |

|e.) |used and stored, etc.). |

| |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.). |

|f.) |Emergency Equipment (how to operate emergency equipment and maintenance required – eyewash, shower, fire blankets and |

| |extinguishers, etc.) |

| | |

|g.) | |

| | |

| | |

|h.) | |

| | |

| |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 |

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