Standard Operating Procedure

Transcription

1 Standard Operating Procedure Functional Assessment Laboratory: Computerized Dynamic Posturography NeuroCom SMART Equitest (S1.113) PC-SOP-FA-003-v03 Revision History Version Reason for Revision Date 01 New SOP 22 August To reflect current practices 15 September New supervisor and Scientific Director, Manager title no longer in effect, changed location of device, to reflect current practices and usage purposes 15 September 2017 Summary The current standard operating procedure (SOP) document provides standards and requirements for using PERFORM s Computerized Dynamic Posturography Laboratory (CDPL), including access to the area, required training, practices for the safe operation of the lab and emergency procedures. PC-SOP-FA-003-v03 Printed copies are not controlled. Page 1 of 7

2 Table of Contents SUMMARY DEFINITION OF TERMS INTRODUCTION BACKGROUND PURPOSE SCOPE RESPONSIBILITY RELEVANT DOCUMENTS CONTROLLED LABORATORY ACCESS PERMISSION TO ACCESS AND USE THE LABORATORY SPACE WITHOUT USE OF EQUIPMENT PERMISSION TO ACCESS AND USE THE LABORATORY WITH SPECIFIC EQUIPMENT ACTIVITIES INVOLVING HUMAN PARTICIPANTS BOOKING A TIME TO USE THE LABORATORY LABORATORY CONFIGURATION HEALTH AND SAFETY MEASURES GENERAL SAFETY RULES APPENDIX 1: SOP TRAINING RECORD FORM PC-SOP-FA-003-v03 Printed copies are not controlled. Page 2 of 7

3 1. Definition of Terms Scientific Director (SD) PERFORM PERFORM operating document (POD) PERFORM employee Principal investigator (PI) CDPL Standard operating procedure (SOP) Supervisor UHREC User Senior executive of PERFORM responsible for all research and administrative aspects of the centre The PERFORM Centre at Concordia University Operating documents that are specific to an instrument or technique. Concordia employee that has been assigned to PERFORM. Head researcher that is responsible for all aspects of a given research project or program at PERFORM. Computerized dynamic posturography research laboratory SOP s at PERFORM are any operating document that require a full review process and approval by the SD. Knowledgeable person regarding all or an aspect of a project or program and is familiar with PERFORM's best practices, that is responsible for ensuring that users conduct their activities in a safe manner and within scope of the project. Concordia University Human Research Ethics Committee. Person using space or equipment at the PERFORM Centre that has received adequate technical and safety training. PC-SOP-FA-003-v03 Printed copies are not controlled. Page 3 of 7

4 2. Introduction 2.1 Background The CDPL hosts the NeuroCom SMART Equitest system, equipment for balance testing and rehabilitation assessments, which provides objective assessment of balance control and postural stability under static and dynamic test conditions designed to reflect the challenges of daily life. The nature of these activities necessitates clear guidelines for user access and safe operation within the CDPL. 2.2 Purpose The objective of the current SOP is to outline the procedure to access PERFORM s CDPL, the minimum training requirements and general rules to be adhered to in the CDPL. It also provides a set of minimum standards and practices for the safe operation of the equipment and space in the CDPL. Finally, the document identifies the expectations, rights and obligations of all users of the CDPL. 2.3 Scope This SOP applies to all users working in the CDPL. 2.4 Responsibility It is the user s responsibility to utilize the space in a safe and responsible manner. It is the responsibility of Functional Assessment Supervisor to ensure that all users have the appropriate background knowledge and hands-on training to safely operate the equipment with human participants. Finally, it is the responsibility of the Assistant Director, Research & Strategic Initiatives to ensure that a safety program is in place, and that inspections of facilities are conducted regularly to ensure compliance with Concordia university regulatory requirements. 2.5 Relevant Documents This SOP is governed by the following policies and SOPs: VPS 40 Environmental Health and Safety VPS 42 Injury/Incident Reporting and Investigation PC-SOP-GA-004 Asset Management at PERFORM PC-SOP-GA-007 General Access to PERFORM Centre PC-SOP-GA-009 Emergency response procedures at the PERFORM Centre PC-SOP-FA-003-v03 Printed copies are not controlled. Page 4 of 7

5 3. Controlled Laboratory Access 3.1 Permission to access and use the laboratory space without use of equipment In order for an individual to be granted access to the laboratory area, the following are required: Gain approval from PERFORM administration (refer to PC-SOP-GA-007 General Access to PERFORM Centre ) Read and sign the present SOP Go through a laboratory orientation with the Functional Assessment Supervisor Adherence to use of PERFORM s online scheduling and approval system at all times (see 3.4 below). 3.2 Permission to access and use the laboratory with specific equipment In addition to the conditions in section 3.1, in order for an individual to be granted further access to the laboratory area and use specific equipment, the user must demonstrate adequate ability to operate the specific equipment involved as well as sign the applicable POD. The Functional Assessment Supervisor is available to provide technical training and ongoing guidance. All users are asked to use the utmost care and consideration for others when operating this equipment. 3.3 Activities involving human participants For all human research projects, approval has been secured from UHREC and the participant has signed an informed consent prior to any procedure being conducted For non-research projects whereby human participants will be exposed to any risk, a PERFORM equipment testing participant information and waiver form has been completed. 3.4 Booking a time to use the laboratory The CDPL is a shared space, requiring responsible planning and consideration for other users. It will be the user s responsibility to book enough time for setting up the room and the equipment, running the experiment, storing the equipment, and ensuring the laboratory remains clean. PC-SOP-FA-003-v03 Printed copies are not controlled. Page 5 of 7

6 In order to book the CDPL, follow the procedure outlined in PC-POD-GA-001 PERFORM Centre Booking System for Facilities and Equipment or go to the PERFORM booking website at: Click on Help for instructions on how to use the online booking site. 3.5 Laboratory configuration At the end of every session it will be the user s responsibility to ensure that the laboratory is left in the configuration as outlined by the Functional Assessment Supervisor. All equipment should be placed back in its assigned location, and any maintenance issues or damage reported to the Functional Assessment Supervisor. 4. Health and Safety Measures 4.1 General Safety Rules Meals are prohibited in the laboratory. Liquids are permitted but must be kept in a closed container, and non-perishable snacks are allowed but must not be consumed near laboratory equipment Smoking is strictly prohibited as PERFORM is a non-smoking facility The disposal of any hazardous materials: biological waste, broken glassware, solvents waste, used hypodermic syringes and needles shall be done according to Concordia University Policy VPS-47 Policy for the management of hazardous materials and PC-SOP-GA-002 Handling of Biological Materials at PERFORM In case of accidents and incidents, follow the procedures outlined in PC-SOP-GA- 009 Emergency Response Procedures at the PERFORM Centre. a) An incident/injury report is to be completed by the principal investigator or supervisor on site and can be found at: FORM-042_InjuryNearMissReportEN.pdf b) Once completed, submit the form to Environmental Health and Safety within 24 hours (ensuring PERFORM also retains a copy). PC-SOP-FA-003-v03 Printed copies are not controlled. Page 6 of 7

7 4.1.5 The last authorized laboratory user to leave the laboratory at the end of the session must make sure that the equipment is turned off and the entrance door is closed. PC-SOP-FA-003-v03 Printed copies are not controlled. Page 7 of 7

8 APPENDIX 1 SOP Training Record Form PC-SOP-FA-003-v03 Printed copies are not controlled. APPENDIX I

9 Functional Assessment Laboratory: Computerized Dynamic Posturography: NeuroCom SMART Equitest (S1.113) Ownership Document type Area SOP Number Version PC SOP FA Training Record Full Name Institution Contact ( or phone number) I certify that I have read and understood the SOP and have concluded an orientation to the Computerized Dynamic Posturography Research Laboratory with the appropriate PERFORM staff member. Signature Sign here (trainee) Date SOP Training Record