ECU Radiation, Biosafety and Hazardous Substances Committee

Transcription

1 Standard Operating Procedure (SOP) Title (Samples Collected from Internal and External Agencies/Institutions) Note: As the infectious status of a patient s sample is unknown, precautions against exposure must be followed Definitions Aliquot a portion of larger whole Aliquoting to divide a larger whole into portions ECU Edith Cowan University First morning urine sample a urine specimen collected when the participant first wakes in the morning NHMRC National Health and Medical Research Council Mid-stream urine sample - a urine specimen collected during the middle of a flow of urine, after the urinary opening has been carefully cleaned OSH Occupational Safety and Health PPE Personal Protective Equipment Random urine sample a urine specimen collected at anytime RBHSC Radiation, Biosafety and Hazardous World Health Organisation 24 hour urine sample urine collected for an exact period of 24 hours Legislative and ECU AS Safety in laboratories - Microbiological safety and containment requirements ECU Immunisation Guideline ECU Human Biomedical Products Collected from External Agencies and Institutions ECU Handling Infectious Materials and Infection Control ECU Human Ethics Page 1 of 7

2 Task Location/s NHMRC Australian Guidelines for the Prevention and Control of Infection in Healthcare 2010 A1.2.1 Standard precautions and Part B: Standard and Transmission- Based Precautions WHO Infection controls standard precautions in health care Locations approved by the RBHSC and that satisfy physical containment level 2 (PC2) requirements. Contact details for: Before commencing this procedure establish the Laboratory Manager of the Area Before commencing this procedure establish the Supervisor of this Activity Risk Assessment and Study Specific Protocol Equipment used Training A task risk assessment has been performed in order to create this standard operating procedure, additional specific study information should be documented and used in conjunction with this SOP. If you are not conducting the task line with this procedure please complete a new or updated task risk assessment and take it to your supervisor for review and approval in line with the risk acceptance criteria. Class II Biological safety cabinet Sample containers Sample tubes Pipettor and rack Sterile pipette tips Sterile disposable pipettes Freezer storage box with lid Biohazard bags zip-lock Biohazard bags large with twist ties Biogram and waste urine container Bench coat Fine tip cryo pen Biohazard sharps disposal bin Biohazard waste disposal bin lined with a biohazard bag( large and small) Vinyl laboratory stool 4 C laboratory fridge - 80 o C Freezer 70% ethanol spray bottle Disposal trolley Urine disposal receptacle i.e. Toilet, pan flusher or flushing sluice Spill Kit scoop/scraper, disposable gloves, protective apron, surgical mask, safety glasses, absorbent agent, biohazard waste bags and ties and detergent( all parts should be disposable to avoid cross contamination) Study specific equipment outlined in study specific protocol Aseptic Techniques Biological Safety Training Hazardous Substances Training Laboratory Induction and Access Page 2 of 7

3 Procedure Steps ECU Radiation, Biosafety and Hazardous OSH Induction PC2 Training Specific Laboratory Equipment Training according to SOPs for the specific equipment( i.e. Class II Biological Safety Cabinet, Autoclave, Cryogenics, Pipetting) Standard(Universal) Precautions Study Specific Protocols Step 1. Health and Safety Requirements 1.1 Ensure you have the recommended immunisations in accordance with ECU Immunisation Guideline. 1.2 Report all hazards and incidents to your Supervisor and the Laboratory Manager (including equipment faults) and in accordance with the ECU Incident Reporting and Investigation Guideline. 1.3 Use aseptic techniques at all times. 1.4 Manage biological spills and other microbiological laboratory disinfection according to requirements refer to TABLE F1 AS Safety in laboratories Microbiological safety and containment. 1.5 Ensure chemicals being used are approved for use in the laboratory and for the task you are completing, read the chemical risk assessment and safety data sheet. 1.6 Keep the work area clean and tidy at all times. 1.7 Dispose of any biological sharps in biological sharps bin. 1.8 Do not leave caps/lids on the bench. The caps/lids should remain under your control throughout the transfer. Procedure/s 1.9 No eating, drinking, chewing or application of lipstick or lip salve in the laboratory. Step 2. Technical Preparation and Laboratory Workspace Setup 2.1 Long hair must be tied up to prevent contamination of and from the samples you are working with. 2.2 Process participant samples on the day they are received or as outlined in the study specific protocol. 2.3 Ensure that you are wearing closed-in footwear, disposable laboratory coat and safety glasses. 2.4 Wash your hands and put on your disposable nitrile or latex gloves. 2.5 Determine what sample tubes are required for each test and the operating Page 3 of 7

4 temperature required for aliquoting i.e. room temperature for 30 minutes or 4 o C. 2.6 Label all participant collection sample containers according to study specific protocol. 2.7 Label all participant study sample tubes according to study specific protocol, ensure samples are de-identified but clearly state the type of sample they contain i.e. human serum. 2.8 Prepare the biological safety cabinet according to its SOP, including cleaning the bench with 70% ethanol solution in spray bottle before working on it (never leave 70% ethanol solution spray bottle on the same bench as a flammable source). NOTE: All work involving unsealed biological samples must only take place in the biological safety cabinet. 2.9 It the biological safety cabinet SOP requires, lay a bench coat in the biological safety cabinet to cover the workspace. Ensure that the absorbent side (non-shiny) is facing up Place the biohazard sharps disposal bin and any other study specific equipment needed to aliquot the unsealed biological samples inside the biological safety cabinet i.e. labelled freezer storage container, sample tubes, pipette, pipette tips and rack, Biogram waste container. Step 3. Sample Aliquoting 3.1 Dependent on the type of biological safety cabinet being used, the height of the person working and the length of the procedure, either sit on a vinyl laboratory stool or stand, while work is taking place in the cabinet. 3.2 Each participant s collection sample container should be processed separately. Individual processing of each participant s collection sample container is important as it prevents accidental swapping of samples. 3.3 Inside the biological cabinet, for each type of study sample aliquot, prepare the pipettor measurement according to the study specific protocol and attach a sterile pipette tip or use a sterile disposal pipette. First morning urine sample, Mid-stream urine sample, Random urine sample 3.4 Inside the biological cabinet gently invert the urine specimen collection container, place it on the bench coat (if used). Gently open each participant s sample container. Using the pipette, draw the appropriate amount of sample from the sample container and transfer to the appropriate study sample tube. Recap as you go. Use the same sterile pipette for all draws from the sample container. Page 4 of 7

5 3.5 Place the sample tube into the freezer storage box. 3.6 Place the used pipette/pipette tip into the small biohazard waste disposal bin lined with a biohazard bag in the biological cabinet. 3.7 While working in the biological cabinet, pour the remaining urine sample into the designated Biogram waste container. Place the recapped sample containers back into the biohazard zip lock bag and into the small biological waste bin. 3.8 Repeat steps 3.4 to 3.8 for subsequent participant urine samples, one participant at a time. 3.9 Place the freezer storage container (containing the aliquotted sample tubes) into the appropriate freezer in their specified tray numbers as per the study specific protocol Place the bench coat in the biohazard waste disposal bin lined with a biohazard bag (small) Securely tie the biohazard bag in the small biohazard waste disposal bin inside the biological cabinet. Place the tied bag into another clean biohazard bag and securely tie it and place it in the large biohazard bin. Contact the Laboratory Manager to establish the days and times that the large biohazard bin will be emptied Securely recap the Biogram waste collection container and place on a trolley, transport to the study specific urine disposal receptacle i.e. toilet, pan flusher or flushing sluice. Note: Remember to remove gloves when opening doors, using the laboratory telephone or pressing lift buttons to gain access to areas outside the laboratory Return the emptied Biogram waste collection container to the laboratory Replace all biohazard bin liners once emptied. 24 hour urine 3.15 Place the trolley with the 24 hour urine samples on it next to the biological safety cabinet Inside the biological cabinet each participant s 24 hour urine collection bottle is weighed on the allocated scales. The results including any comments (i.e. more than one sample bottle used) are recorded and any calculations made as per the study specific protocol. Page 5 of 7

6 3.17 Inside the biological cabinet, ensure the cap of the 24 hour urine collection bottle is securely screwed on and mix the urine sample by gently inverting the bottle 5 times, holding the bottle securely with one hand and the cap with the other If the urine is contained in more than one bottle, another laboratory assistant will be required to assist with securing bottles while the urine is mixed between the sample bottles as per the study specific protocol. Mixing of samples must occur in the biological cabinet In the biological cabinet, get the chosen pipette ready, unscrew the cap for the sterile screw top sample container and place it on the bench. Ensure the cap is facing up at all times Unscrew the cap of the prepared 24 hour urine collection bottle as per the study specific protocol. Proceed to aliquot the study specific amount of urine into the labelled sterile screw top container Screw the cap back onto the 24 hour urine collection bottle for that participant and place it back into the storage container it arrived in and onto the trolley ready for disposal Using the same pipette for the sample, transfer the study specific amounts of urine into the required sample containers. Recap as you go. Place aliquotted samples into study specific storage containers and store as outlined in study specific protocol Dispose of the used pipette/pipette tips in small biological waste bin in the biological cabinet While working in the biological cabinet, pour the remaining urine sample from labelled sterile screw top container into the designated Biogram waste container Once all 24 hour urine samples have been aliquotted, the recapped 24 hour urine collection bottles should be placed in the cooler bags on the trolley ready to be disposed of in the study specific urine disposal receptacle i.e. toilet, pan flusher or flushing sluice. Note: Spills of potentially infectious materials should be promptly cleaned as follows: Access laboratory spill kit Put all PPE contained in the kit on Confine and contain the spill clean visible matter with disposable absorbent material and place all materials in the biohazard waste bin Clean the spill area with a cloth or paper towel using detergent solution ( use chemical disinfectants such as sodium hypochlorite based on assessment of risk of transmission of infectious agents from that spill Page 6 of 7

7 Step 4. Laboratory Take Down 4.1 Clean bench with 70% ethanol solution in spray bottle after working on it (never leave 70% ethanol solution spray bottle on the same bench as a flammable source). 4.2 Shut down the Biological Cabinet according to the SOP for shutting down. 4.3 After completing your work with the samples, remove your laboratory coat and gloves carefully and wash your hands thoroughly. CONTACT INFORMATION Procedure Owner All Enquiries Contact: address: Chair Radiation Biosafety Hazardous Radiation Biosafety Hazardous RBHSC@ads.ecu.edu.au APPROVAL HISTORY Procedure Approved by: Chair Radiation Biosafety Hazardous Date Procedure First Approved: January 2017 Date last modified: January 2017 Revision History: V01.03 Procedure first approved document Next Revision Due: January 2020 HPRM File Reference HSMS/84 Page 7 of 7