Standard Operating Procedure General Procedures for Sleep Laboratory Access at PERFORM PC-SOP-RL-003-v01 Revision History Version Reason for Revision Date 01 New SOP March/17/2015 Summary The content of this standard operating procedure (SOP) provides guidelines for all activities in the Sleep Laboratory at the PERFORM Centre. The laboratory provides a variety of services for research into the neurobiology of sleep in human participants. This SOP provides standards and requirements for using the sleep laboratory including access to the area, responsibilities and mandatory training for all users, practices for safe operation within the area, and emergency procedures. PC-SOP-RL-003-v01 Printed copies are not controlled. Page 1 of 6
Table of Contents Summary --------------------------------------------------------------------- 1 1. Definition of Terms ---------------------------------------------------- 3 2. Introduction ------------------------------------------------------------- 4 2.1. Background ----------------------------------------------------------------------------------------------------------- 4 2.2. Purpose ----------------------------------------------------------------------------------------------------------------- 4 2.3. Scope -------------------------------------------------------------------------------------------------------------------- 4 2.4. Responsibility --------------------------------------------------------------------------------------------------------- 4 2.5. Relevant Documents ---------------------------------------------------------------------------------------------- 5 3. Procedure --------------------------------------------------------------- 5 3.1. Access to the sleep laboratories------------------------------------------------------------------------------ 5 3.2. Booking a time to use the Sleep Laboratory ------------------------------------------------------------ 6 4. General laboratory safety rules --------------------------------------- 6 5. Emergency response ---------------------------------------------------- 6 APPENDIX 1: Emergency Procedures APPENDIX II: SOP Training Record Form PC-SOP-RL-003-v01 Printed copies are not controlled. Page 2 of 6
1. Definition of Terms Area or Core Area Collaborator Coordinator, Sleep Labs Educational program Instructor Internship student PERFORM Platform Polysomgraphy (PSG) Principal Investigator (PI) Research project Standard Operating Procedure (SOP) The PERFORM Department or lab area that a piece of equipment resides in or it managed by. Someone who works with a user, project/program lead or principal investigator on a project or program at PERFORM. Person responsible for coordinating the research, community, and teaching activities in the Sleep Labs. Operational set of activities at PERFORM that fit with the educational mandate of the centre. This includes providing facilities for classes offered by faculty at Concordia or any educational program administered by PERFORM employees. Person that has attained an adequate level of certification and expertise which qualifies them to supervise and teach students. An internship student is a current student or recent graduate that is undergoing supervised practical training supervised by PERFORM employees. The PERFORM Centre at Concordia University The individual equipment, instrument, or other facility that can be booked. The study of the continuous and simultaneous recording of multiple physiologic variables during sleep. Head researcher that is responsible for all aspects of a given research project or program at PERFORM. Set of activities that are designed to answer questions regarding preventative health. SOP s at PERFORM are any operating document that require a full review process and approval by the SD. PC-SOP-RL-003-v01 Printed copies are not controlled. Page 3 of 6
2. Introduction 2.1. Background The intent of this document is to ensure research activity at PERFORM follow a common and fair set of standards and requirements for all users of the sleep laboratories relative to access and safe use of this specific area. The sleep laboratory consists of specialized equipment such as polysomnography. Polysomnography (PSG) is another name for "Sleep Study". It is the study of the continuous and simultaneous recording of multiple physiologic variables (e.g. electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, respiratory movements, and leg movements) during sleep. The Sleep Labs at PERFORM consist of furnished bedrooms and a general purpose lab space for research staff to use for monitoring and setting up the research participants. Each bedroom is equipped with closed-circuit IR video camera (and IR LED) and a conduit for connecting monitoring equipment between the bedrooms. The nature of the activites conducted in this area warrants a need for procedures to ensure safety of all users. 2.2. Purpose This SOP provides a set of minimum standards and practices for the safe access and use of the sleep laboratory at the PERFORM Centre of Concordia University. It outlines the minimum training requirements and general rules to be adhered to in the sleep laboratories. It outlines the procedure to access the laboratories, minimum training requirements and general rules to be adhered to in the lab. 2.3. Scope This SOP applies to all persons working in the sleep laboratories at the PERFORM Centre including but not limited to University faculty, staff, students, research participants and authorized visitors. 2.4. Responsibility Responsible access and operation of the sleep laboratory by different users is outlined as follows: 2.4.1. All Users All users of the sleep laboratory are responsible for: 2.4.1.1. Following all applicable regulations, safety rules and practices as outlined in this SOP as well as applicable Concordia policies. 2.4.1.2. Reporting any incidents, injuries, hazards, or damage to equipment or property to the Coordinator of the Sleep Laboratory. PC-SOP-RL-003-v01 Printed copies are not controlled. Page 4 of 6
Attending all training courses as directed by the Coordinator of the Sleep Laboratory 2.4.1.3. Remaining current on and able to identify all evacuation routes and procedures for emergency response, including location of emergency equipment (such as fire extinguishers, spill kits, emergency showers/eye washes and emergency phones). 2.4.1.4. Completion of recommended occupational health screening programs when applicable. 2.4.2. Coordinator, Sleep Laboratory The Coordinator has overall responsibility for: 2.4.2.1. Administration of the sleep laboratory at PERFORM. 2.4.2.2. Overseeing and approving the identification, establishment, and updating of any SOP/PODs for the sleep laboratory. 2.4.2.3. Reviewing all proposed protocols. 2.4.2.4. Ensure that the equipment is used correctly by competent personnel who are properly trained. 2.4.2.5. Ensuring all users (including technologists and auxiliary staff, principal investigators/project leaders and their teams) have completed requisite training on PSG and to operate any equipment or access relevant areas of the sleep laboratory. 2.5. Relevant Documents This SOP is governed by the following Concordia University policies and SOPs: VPS-42 Policy on injury/incident reporting and investigation PC-SOP-GA-004 Asset Management at PERFORM PC-SOP-GA-002 Handling of Biological Materials at PERFORM PC-SOP-GA-003 Acquisition, use and disposal of chemicals PC-POD-GA-001 PERFORM Centre Booking System for Facilities and Equipment PC-SOP-GA-007 General Access to PERFORM Centre PC-SOP-GA-009 Emergency Response Procedures at the PERFORM Centre PC-SOP-GA-011 Guidelines for Management of Incidental Findings at PERFORM 3. Procedure 3.1. Access to the sleep laboratories Access will only be granted to users who meet the following requirements: PC-SOP-RL-003-v01 Printed copies are not controlled. Page 5 of 6
3.1.1. PI to provide list of team members to PERFORM administration that will ultimately have access to the space according to PC-SOP-GA-007, General Access to PERFORM Centre. 3.1.2. For any other specific projects (e.g. method development or feasibility requiring a specific instrument), it is mandatory to notify the coordinator of the Sleep Laboratory prior to use of the facility. 3.1.3. Have read and signed the current SOPs 3.2. Booking a time to use the Sleep Laboratory 3.2.1. It will be the user s responsibility to schedule in advance enough time for setting up the equipment, running the experiment, storing the equipment, and cleaning the space. All equipment should be placed back in its assigned location. 3.2.2. In order to book the PERFORM Sleep Laboratories, follow the procedure outlined in PC-POD-GA-001 PERFORM Centre Booking System for Facilities and Equipment or go to the website, http://perform.concordia.ca/booking/ and then go to Help for the online booking procedure. 4. General laboratory safety rules 4.1. Upon completion of laboratory procedures, remove all personal protective equipment including gloves and laboratory coats inside the laboratories. 4.2. The laboratory area shall be cleaned as soon as possible after usage. 4.3. All non-hazardous waste material shall be disposed of in a garbage container. Materials no longer used must not be allowed to accumulate and must be disposed of following proper procedures. 4.5. The disposal of hazardous materials: chemicals waste, solvents waste, biological waste, broken glassware, used hypodermic syringes and needles shall be done according to Concordia University Policy VPS-47 Policy for the management of hazardous materials and PERFORM SOPs PC-SOP-GA-002 and PC-SOP-GA-003. 4.8. Last authorized laboratory worker to leave the laboratory at the end of the office hours must make sure that the equipment they were using is switched off and the doors closed. 5. Emergency response Refer to Table 1 in APPENDIX I and emergency information posters in the sleep laboratory. PC-SOP-RL-003-v01 Printed copies are not controlled. Page 6 of 6
APPENDIX 1: Emergency Procedures PC-SOP-RL-003-v01 Printed copies are not controlled. APPENDIX I
Fire Alarm and Evacuation Recognize alarm type 1 stage* vs 2 stage When you hear an Alarm: 1) Stay Calm 2) Direct occupants of room to nearest emergency exits* (see diagrams for specific areas) 3) Once outside proceed to gathering point at fence bordering Sherbrooke Street. During bad weather proceed to CJ Atrium building across Sherbrooke Street (see map). 4) Await further instructions from security/perform Staff before re-entering building. Note that PERFORM staff must re-enter before all other individuals. PERFORM CENTRE RESPONDING TO AN EMERGENCY Power Outage The PERFORM Centre is equipped with a generator that will provide essential power in the event of a power outage. There is a 30 second delay before it begins operation. During the first 30 seconds please stay calm, when the lights come on and generator is in operation CALL SECURITY (3717) and indicate there is a power outage. Security will contact the PERFORM on call staff member. Await further directions from the PERFORM on call staff member who will contact PERFORM front desk staff. NOTE: Fitness equipment/rear elevator will not work on generator. Only lights will operate to provide a safe evacuation. Minor Medical Emergency (non-life threatening) 1) Instruct victim to stop activity 2) Remain with victim until symptoms subside. a) If symptoms worsen, use basic first aid*. Do not give anything to drink or eat b) If symptoms do not subside, activate 911 or as instructed by trained medical first responder. * At this time, if appropriate, have another person check with reception (ext. 4037 or 4023) if a trained medical first responder is in the building. Have someone get this individual and return to you. Major Medical Emergency (life-threatening) If a person is complaining of or suffering from any of the following signs/symptoms: Sharp pain or pressure in the chest area, arm, jaw or middle of back. A sudden and intense headache Problem breathing (not usual with exercise) A loss of consciousness Activate 911 by calling Security (3717) immediately (retrieve closest AED and First Aid kit ) At this time, if appropriate, have another person check with reception (ext. 4037 or 4023) if a trained medical first responder is in the building. Have someone get this individual and return to you. NOTE: this should not override the need to activate 911 if required. Provide victim cpr/first-aid (AED if appropriate) Do not give the victim anything to drink or eat To activate 911 CONTACT SECURITY IMMEDIATELY (call 3717) Use one of the following options: 1) Telephone land line and call 3717 OR locate a YELLOW emergency call box 2) From a cell phone 514-848-3717 (IMPORTANT: IF YOU REQUIRE 911 TO GUIDE YOU AS YOU ADMINSTER CARE TO THE INDIVIDUAL, CALL SECURITY FROM A CELL PHONE OR A CORDLESS TELEPHONE LOCATED AT THE PERFORM FRONT DESK. SECURITY WILL CONNECT YOU TO A 911 AGENT) Be prepared to give as much information about the emergency as you can. Note: The security dispatcher will ask questions and/or connect you with 911. Do not hang up until you are told to do so. The dispatcher may also give you instructions.
APPENDIX II: SOP Training Record Form PC-SOP-RL-003-v01 Printed copies are not controlled. APPENDIX II
SOP Title General Procedures for Sleep Laboratory Access at PERFORM SOP Code Ownership Document type Area SOP Number Version PC SOP RL 003 01 Training Record Full Name Institution Contact (email or phone number) Signature Sign here and return to SOP custodian Date