Appendix A : Good Laboratory Practices Questionnaire Name of Laboratory: ____________________________________ Date: ______________ Address: _________________________________________________________________ Country:_____________________ Tel: _________________________________________ E-mail address:______________________________Fax:___________________________ Head of the laboratory: _____________________________________________________ Position: _________________________________________________________________ 1. BIOSAFETY General Laboratory Safety Personnel has received laboratory safety training....……………………………..…………………………. Yes No A « Safety Handbook » is provided to each new arrival ……………………………………………………. Yes No Biosafety regulations are documented, updated, and available for consultation ………………………… Yes No Hazard warning labels are properly used: UV, lasers, radioactive substances, etc. .............................. Yes No The laboratory is equipped with an eyewash station............................................................................... Yes No The laboratory is equipped with an emergency shower ……………........................................................ Yes No Laboratory equipment is clearly labeled for biological hazard, toxic risk, etc.……………………............. Yes No Flammable substances are stored in a safety cabinet ............……………...........…............................... Yes No Food and drinks are not permitted in the laboratory ……………………………………..…………………. Yes No Biosafety practices include: a. Washing of hands …………………………………………………………………………………..Yes No b. Use of mechanical pipettes………………………………………………………….……………..Yes No c. Wearing of gloves, lab coats, and protective eyewear ………………………………………… Yes No e. Decontamination of all trash containers containing infected waste ….………………………. Yes No f. Decontamination of laboratory bench tops……………………………………………………….. Yes No The head of the laboratory maintains a safety logbook of incidents/accidents that have occurred on site…………………………………………………………………………………………………………………. Yes No The laboratory is equipped with a water and a powder fire extinguisher………………………………….. Yes No Lab technicians have been trained in or are familiar with the use of fire extinguishers………….……… Yes No Emergency exits in the laboratory are clearly marked ………………………………………………….…... Yes No Laboratories are checked that lab coats are replaced, areas are tidy, supplies are kept up to date…… Yes No Emergency instructions in case of exposure to chemical or biological hazards are posted in the laboratory………. ……………………………………………………………………………………………………………………... Yes No Freezer gloves for temperatures to minus 80°C are located near the freezers…………………………… Yes No Equipment Scientific instruments are in working order and in good condition………………………………………… Yes No Scientific instruments have identification and registration numbers……………………………………… Yes No Scientific instruments are checked regularly in accordance with recommendations, and dates of maintenance are recorded …………………………………………………………………………………………………………. Yes No The temperatures of incubators, refrigerators, and freezers are recorded daily………………………….. Yes No The measurement accuracy of balances is checked………………………………………………………… Yes No The measurement accuracy of pipettes is checked…………………………………………………………. Yes No Key lab equipment (refrigerators, freezers, PCR machines) is connected to a backup power system… Yes No Backup cold storage is available in case of breakdown of refrigerators or freezers …………………….. Yes No GABRIEL / GLP questionnaire/ FP / February 2011 / V1 1 Appendix A : Good Laboratory Practices Questionnaire Level 2 Laboratory Biosafety: Access to the laboratory is restricted to authorized personnel……………………………………………... Yes No Access is restricted to personnel aware of risk of exposure to all types of hazards………………..……. Yes No Biological hazard warning signs are posted at the laboratory entrance.…………………........................ Yes No Mandatory individual protective equipment (protective smocks, gloves, eyewear) is worn exclusively in the laboratory………………………………………………………………………….……………………………… Yes No Lab wear and street wear are kept in distinctly separate lockers. .......……............................................ Yes No Air pressure in the different laboratory rooms is monitored. ………………..……………………………… Yes No Procedures have been set up in case of changes in pressure differential………………………………... Yes No Biological Safety Cabinets (BSC) Biological safety cabinets are maintained according to specifications, including the replacement of air filters, and dates of maintenance are recorded. ………………………………………………………………………….. Yes No A complete inventory of pathogens and other potentially infectious specimens is maintained………… Yes No The BSCs received prior year certification.......……………………………………..................................... Yes No The BSC workbench is appropriately disinfected before and after each use………………………….…. Yes No Biological safety cabinets are uncluttered. …………………………………………………………………… Yes No Air grates and evacuation filters are clog-free ..……………………………………………………………… Yes No Centrifuge buckets and rotors can only be opened inside a BSC .........………....................................... Yes No Infectious samples for use outside a BSC are carried in approved containers that meet specified regulations for transport of such samples ....................……………………………………………………………………….. Yes No Pipettes are exclusively assigned to a microbiological security station and cannot be used at other workbenches………………..……………………………………………………………………………………. Yes No All BSC wastes (bacteriological loops, spreaders, cones, suspensions) are discarded into a workbench container, sealed, and transferred to DASRI for disposal ……….…………………………………………..…………. Yes No Specimen handling is carried out exclusively in a BSC …………………………………………………….. Yes No 2. WASTE Waste Management Warning signs are posted against improper waste disposal………………………………………………... Yes No Wastes are segregated and collected in suitable containers......……………........................................... Yes No Chemical waste containers are identifiable, labeled, dated, and sealed................................................. Yes No Chemical waste containers are properly handled and stored ........…………........................................... Yes No Containers for sharp and cutting waste are properly handled and disposed of .........………………....... Yes No Acid waste, basic waste, and solvents are stored in separate containers ………………………………... Yes No Uncontaminated paper, cardboard, and plastic waste is discarded into office trash cans ……………… Yes No Floors are litter-free ..........................…………………………………………………………………............. Yes No Waste disposal instructions are posted ............……............................................................................... Yes No Handling of contaminated waste Containers for contaminated waste are used ………………………………………………………………... Yes No Specific biological waste containers are assigned to each biological laboratory ……...……..………….. Yes No Waste containers are not filled to the brim.....………………………………………………………………... Yes No Waste containers are properly labeled and sealed………………………………………………………….. Yes No Cultures and other materials subject to waste regulations are properly decontaminated before disposal ………….. ……………………………………………………………………………………………………………………... Yes No Decontaminated substances carried outside of the laboratory are placed in hard, sealed, leakproof containers in accordance with local regulations …………………….......................................................……………..... Yes No Waste decontamination Decontamination processes are microorganism-specific ..............................………………………......... Yes No The head of the laboratory is informed when infectious material has been released or is implicated in an accident ……………………………………………………………………………………………………………………... Yes No A suitable decontaminating agent is used to remove infectious material that has been released……… Yes No Workbenches are cleaned daily before and after each use and when infectious material has been spilled .............. …………………………………………………………………………………………………………………….. Yes No GABRIEL / GLP questionnaire/ FP / February 2011 / V1 2 Appendix A : Good Laboratory Practices Questionnaire Substances that are cancerogenic, mutagenic, or toxic for reproduction (CMR) (beta mercapto ethanol etc…) Lab rooms and stations where CMRs are handled or stored are properly marked…………..………….. Yes No Cleaning personnel is prohibited from entering a CMR lab room……………………………….…………. Yes No Double gloving is required for handling CMRs ………………………………………………………………. Yes No STORAGE Refrigerators and freezers are grouped according to contamination levels………….…….……………... Yes No Inoculated Petri dishes are kept in specific refrigerators or on specific shelves…………………………. Yes No PCR primers and probes are kept separately from PCR products ………………………………………… Yes No Human samples are kept in specifically designated hoods or on specific shelves ………….…………… Yes No TRACABILITY Reactive agents and samples are labeled with the following information: name, date, storage temperature, expiry date………………………………………………………………………………………………………………... Yes No Each technician maintains a logbook of laboratory procedures and tests………………………………… Yes No 3. PCR ROOMS Samples are prepared exclusively in a designated PCR room (extraction of nucleic acids) …………… Yes No The extraction room is designated as BSL-2…………………………………………………………………. Yes No Samples are handled at a microbiological security station………………………………………………….. Yes No In the extraction room, the wearing of individual protective equipment (smocks, gloves) is mandatory. Yes No Protective equipment is specifically designated to the extraction room…………………………………… Yes No The handling of human samples requires double gloving ……… …………………………………………. Yes No The second pair of gloves must be removed before leaving the room……………………………..……… Yes No A room is specifically designated for the preparation of the mix ………..…………………………………. Yes No Reactive agents are stored in the mix preparation room…………………………………………..………... Yes No The mix is prepared in a sealed room………………………………………………… ……………………... Yes No In the mix preparation room, the wearing of individual protective equipment (smocks, gloves) is mandatory………. ……………………………………………………………………………………………………………………... Yes No Protective equipment is specifically designated to the mix preparation room…………………………….. Yes No Amplification is carried out in a specifically designated room………………………………………………. Yes No In the amplification room, the wearing of individual protective equipment (smocks, gloves) is mandatory………….. ……………………………………………………………………………………………………………………... Yes No PCR product analysis is carried out in a specifically designated room ……………………………….…... Yes No The policy of assigned materials and equipment to specific rooms is respected………….……………... Yes No I certify that all information is true and complete Date : Name and Signature : GABRIEL / GLP questionnaire/ FP / February 2011 / V1 3