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PC-SOP-CP-001-v01

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Standard Operating Procedure

Cardiopulmonary Suite

Access, Use, Safety, and Training of Personnel

(S1.167-1.172)

PC-SOP-CP-001-v01

Revision History

Version Reason for Revision Date

01 New SOP 16-November-2012

Summary The PERFORM Cardiopulmonary Suite (CP Suite) provides researchers an area for conducting studies involving cardiopulmonary, musculoskeletal and metabolic interactions in humans. In addition, the CP Suite will be used for educational and/or community programs/projects. The current standard operating procedure (SOP) document provides standards and requirements for using the CP Suite including access to the area, required training, practices for the safe operation of the Suite, and emergency procedures.

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Table of Contents

STANDARD OPERATING PROCEDURE --------------------------------------- 2

CARDIOPULMONARY SUITE ----------------------------------------------------- 2

SUMMARY ------------------------------------------------------------------------------ 2

I. DEFINITION OF TERMS --------------------------------------------------------- 4

2. INTRODUCTION ---------------------------------------------------------------- 6

2.1 BACKGROUND -------------------------------------------------------------------------------------------- 6 2.2 PURPOSE --------------------------------------------------------------------------------------------------- 6 2.3 SCOPE ------------------------------------------------------------------------------------------------------ 6 2.4 RESPONSIBILITY -------------------------------------------------------------------------------------------- 6 2.5 RELEVANT DOCUMENTS --------------------------------------------------------------------------------- 7

3. CONTROLLED LABORATORY ACCESS ----------------------------------- 7

3.1 GENERAL ACCESS TO THE CP SUITE -------------------------------------------------------------------- 7 3.2 ACCESS AND USE OF THE CP SUITE FOR RESEARCH PURPOSES -------------------------------------- 8 3.3 ACCESS AND USE THE OF THE CP SUITE FOR EDUCATIONAL/COMMUNITY PURPOSES ------------ 8 3.4 CLEARANCE FOR PHYSICAL ACTIVITY ------------------------------------------------------------------- 8 3.6 INCIDENTAL FINDINGS ----------------------------------------------------------------------------------- 9

4. TRAINING ------------------------------------------------------------------------- 9

4.1 ORIENTATION --------------------------------------------------------------------------------------------- 9 4.2 TRAINING -------------------------------------------------------------------------------------------------- 9 4.3 CERTIFICATES --------------------------------------------------------------------------------------------- 9

5. HEALTH AND SAFETY MEASURES ----------------------------------------- 10

5.1 GENERAL SAFETY RULES -------------------------------------------------------------------------------- 10 5.2 LABORATORY EQUIPMENT MAINTENANCE ------------------------------------------------------------ 12

6. EMERGENCY PROCEDURES ------------------------------------------------- 13

APPENDIX 1 -------------------------------------------------------------------------- 14

EMERGENCY PROCEDURES ----------------------------------------------------- 14

APPENDIX 11 ------------------------------------------------------------------------ 17

TRAINING CHECKLIST ------------------------------------------------------------ 17

APPENDIX 111 ----------------------------------------------------------------------- 20

SOP TRAINING RECORD FORM ------------------------------------------------ 20

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I. Definition of Terms

SOP Standard operating procedure

Chief administrative officer (CAO)

Senior executive of PERFORM responsible for administrative aspects of the Centre.

Area manager Person responsible for all activities in a given area of PERFORM such as the athletic therapy clinic, clinical analysis laboratories, conditioning floor, etc.

Instructor Person that has attained an adequate level of certification and expertise which qualifies them to supervise and teach students.

PERFORM employee

Concordia employee that has been assigned to PERFORM.

Supervisor

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.

User Person using space or equipment at the PERFORM Centre that has received adequate technical and safety training.

Cardiopulmonary suite (CP suite)

Cardiopulmonary suite encompasses five (5) CP stations, one (1) 17 meters walking area, one (1) equipment cleaning area, one (1) viewing station, and one (1) office.

Cardiopulmonary station (CP station)

Cardiopulmonary station refers to one (1) area of the CP Suite, which is equipped with a metabolic cart integrated with 12 lead ECG, a treadmill, and a bike. Two of such CP Station also have a body plethysmograph.

WHMIS

The workplace hazardous materials information system (WHMIS) is a component of the hazard communication scheme in laboratory. WHMIS regulations set out requirements for workers training, hazardous materials labeling, and provision of Material Safety Data Sheets (MSDSs).

Personal protective equipment (PPE)

Specialized clothing or equipment worn for protection against health and safety hazards. Lab coats, gloves, safety goggles, face shields, long pants, closed toe shoes etc.

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I. Definition of Terms (con’t)

Interim research committee (IRC)

The scientific research committee (see definition for SRC) when an interim chair has been appointed.

Scientific research committee (SRC)

PERFORM committee chaired by the scientific director with the mandate to evaluate new research projects for scientific merit and fit with overall mission.

Cross functional evaluation team (CFET)

Body at PERFORM that evaluates the feasibility of any given project or program within PERFORM.

Community programs

A set of operational activities in preventative health administered by PERFORM employees that are open to the general public. Examples include Le Centre and the athletic therapy clinic.

Community project A new set of community services offered by PERFORM open to the general public where the end result is either a community program or completion of the project.

Educational program 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.

Educational project A new set of activities within the educational scope of Concordia University. For instance, a pilot project to test a new educational tool before making it part of the regular curriculum of the university.

Incidental findings Incidental findings are unexpected discoveries or observations of potential clinical significance detected during the course of a study/activity that are outside the scope, or unrelated to the purpose or variables, of the study/activity.

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2. Introduction

2.1 Background

Research, educational and/or community programs/projects are the activities that will be conducted in the cardiopulmonary suite. The variety of the activities conducted in this area warrants the development of a common and fair set of standards and requirements for all users of the CP Suite at the PERFORM Centre.

2.2 Purpose

The objective of the current SOP is to outline the procedure to access PERFORM’s CP Suite, minimum training requirements, and general rules to be adhered to in the CP Suite. It also provides a set of minimum standards and practices for the safe operation of the equipment and space in the CP Suite at PERFORM Centre. Finally, the document identifies the accompanying expectations, rights and obligations of all users of the CP Suite at the PERFORM Centre, Concordia University.

2.3 Scope

This SOP applies to all users conducting work in the CP Suite, at the PERFORM Centre, Concordia University.

2.4 Responsibility

2.4.1 Users

All users are responsible for:

2.4.1.1 Following all applicable safety rules and practices as outlined in the current and all related SOPs and PODs (see section 2.5) to assure the safe conduct and high quality of laboratory activities;

2.4.1.2 Reporting all potential hazards, unsafe conditions or safety issues to the cardiopulmonary instructor. Being familiar with the PERFORM emergency response procedures (see APPENDIX I and PC-SOP-GA-009), as well as knowing evacuation routes from the CP Suite and the location of emergency equipment such as fire extinguishers, first aid kit, AED, and emergency phones;

2.4.1.3 Using and wearing personal protective equipment according to instructions, (see section 5.1);

2.4.1.4 Attending all training courses as directed by the current SOP and supervisor.

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2.4.2 Supervisor The area manager has overall responsibility for safety and general training of supervisors and/or users. Working with supervisors, the area manager will ensure that all users of the CP Suite have completed the proper training to be able to conduct activities in a safe manner.

2.4.3 Principal investigator/Project lead

The principal investigator/project lead is responsible for ensuring their team members, and all users in their protocols /projects and activity have completed the proper training to be able to conduct activities in a safe manner (i.e., read and sign off all required SOPs and PODs and any additional operational manuals, as well as demonstrate adequate abilities to use the equipment).

2.4.4 Chief administrative officer (CAO)

The PERFORM Centre CAO is responsible for ensuring that a safety program is in place, and that reviews are conducted regularly to ensure compliance with Concordia University regulatory requirements.

2.5 Relevant Documents

This SOP is governed by the following Concordia University policies and SOPs: VPS-47 “Policy for the management of hazardous materials” VPS-48 “Hazardous material spill response policy” PC-SOP-GA-007 “General Access to PERFORM Centre” PC-SOP-GA-009 “Emergency Response Procedures at PERFORM” PC-SOP-GA-002 “Handling of Biological Materials at PERFORM” PC-SOP-GA-011 “Management of Incidental Findings at PERFORM” PC-POD-CR-001 “Clearance for Physical Activity at PERFORM” PC-POD-GA-002 “Scheduling practices at the PERFORM Centre” PC-POD-CP-002 “Cleaning, Maintenance, and Calibration Procedures for Automatic and Manual Aneroid Sphygmomanometers” PC-POD-CP-001 “Maintenance and Cleaning of Respiratory Equipment”.

3. Controlled laboratory access

3.1 General access to the CP Suite

For directions regarding access to the CP Suite users shall refer to PC-SOP-GA-007 “General Access to PERFORM Centre”.

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3.2 Access and use of the CP Suite for research purposes

In order for an individual to be granted access to the laboratory area the following are required:

3.2.1 Research project has undergone PERFORM research application process and received acceptance;

3.2.2 The individual is listed in the document presenting the research team members that need access to the CP Suite that was previously provided by the PI to the CFET;

3.2.3 Individual follows a PERFORM Centre orientation session.

3.2.4 Individual follows a laboratory orientation session which includes equipment training (see Training section 4.0), emergency response procedures (see APPENDIX I), and safety practices;

3.2.5 Individual reads and signs the present SOP;

3.2.6 Individual demonstrates adequate ability to operate the specific equipment at which time the cardiopulmonary instructor signs off on a training record form (see APPENDIX II).

3.3 Access and use the of the CP Suite for educational/community purposes

3.3.1 Educational and/or community program/project has been reviewed and received acceptance by the assigned committee;

3.3.2 Individual follows a laboratory orientation session provided by the cardiopulmonary instructor which includes equipment training (see Training section 4.0), emergency response procedures (see APPENDIX I), and safety practices;

3.3.3 Individual involved in delivering community/educational program/project reads and signs the present SOP;

3.3.4 Individual demonstrates adequate ability to operate the specific equipment at which time the cardiopulmonary instructor signs off on a training record form (see APPENDIX II).

3.4 Clearance for physical activity

3.4.1 All PERFORM users and participants are required to undergo an appropriate screening/clearance protocol for physical activity as per PC-POD-CR-001 “Clearance for Physical Activity at PERFORM” prior to commencement of equipment testing and other educational or community activities that require the individual to be physically active.

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3.4.2 Research participants engaging in physical activity will undergo “Clearance for Physical Activity at PERFORM” as per PC-POD-CR-00. The collected screening data will determine the level of medical supervision required during exercise testing as per PERFORM risk-stratification screening standards.

3.5 Booking Equipment

It will be the supervisor’s responsibility to book enough time for setting up the CP station equipment, running the experiment, storing the equipment, sterilizing and cleaning the equipment and space. At the end, equipment should be placed back in its assigned location.

To book one or more CP station(s) in the CP Suite follow the procedure outlined in PC-POD-GA-002 “Scheduling practices at the PERFORM Centre”.

3.6 Incidental Findings

Due to the nature of activity within the PERFORM Centre there is the potential for incidental findings. For further details on the management of incidental findings please refer to: PC-SOP-GA-01I “Management of Incidental Findings at PERFORM.”

4. Training

4.1 Orientation

Prior to gaining access to the PERFORM Centre, all users will be required to attend a PERFORM Centre orientation session as outlined in PC-SOP-GA-007 “General Access to PERFORM Centre”. Then, individuals will also follow a CP Suite orientation session.

4.2 Training

Specific training procedures will vary for each piece of equipment; however, the following general elements should apply to all training:

4.2.1 Complete training on all applicable SOPs and PODs (see 2.5 “Relevant documents” and APPENDIX II );

4.2.2 Review any applicable operator manual instructions; 4.2.3 Practice using equipment; 4.2.4 Demonstrate adequate ability to operate equipment with limited supervision; 4.2.5 Undergo equipment decontamination procedures training.

4.3 Certificates

Due to the variety of work being conducted in the CP Suite, specific user certifications will be required.

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4.3.1 Activities involving human blood/body fluids, tissues, and exercise testing require that users undergo relevant training, and obtain the corresponding certificate as per Concordia University and PERFORM Centre policies and standards. Training is available through Environmental Health and Safety Office training and/or PERFORM Centre and must be completed by all users prior to work initiation. Certificates required will depend on research and educational/community programs/projects conducted and each user’s level of involvement in these activities. Supervisors are responsible for ensuring that all staff involved in research and educational/community program/projects have undergone the necessary training.

4.3.1.1 WHMIS by the university chemical safety officer;

4.3.1.2 Biosafety and blood safety;

4.3.1.3 Emergency First Aid/CPR-A and AED training;

4.3.1.4 CSEP certified exercise physiologist or equivalent, which will be requested based on the activity being conducted and the qualified personnel involved.

NOTE: Emergency First Aid/CPR and AED trained personnel must be present during all lab activities. In the event the activity is conducted during a time that PERFORM staff are not present it will be the supervisor’s responsibility to ensure there is at least one person trained with Emergency First Aid/CPR and AED.

5. Health and safety measures

5.1 General Safety Rules

5.1.1 Food is not permitted in the laboratory, unless otherwise required by a research protocol;

5.1.2 All liquids need to be in a closed container;

5.1.3 All personnel actively working in the laboratory should wear personal protective equipment (PPE) when running an assessment (lab coats and gloves, long pants or clothes that provide maximum protection and cover most of the skin);

5.1.4 Closed toe footwear shall be always worn in the laboratory to protect feet against a variety of injuries such as impact, compression, punctures, etc.;

5.1.5 Wash hands upon completion of laboratory procedures and remove all protective equipment including gloves and lab coats inside the laboratory;

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5.1.6 Consider gloves to be contaminated after use and dispose of appropriately as indicated in PC-SOP-GA-002 “Handling of Biological Materials at PERFORM” and VPS-47 “Policy for the management of hazardous materials”;

5.1.7 Over-clothes shall be kept in designated places at all times (e.g., lockers etc.);

5.1.8 Designated laboratory areas shall be used for each task;

5.1.9 Avoid disturbing or distracting other laboratory workers while they are performing laboratory tasks;

5.1.10 Visitors or tours in the CP Suite shall be coordinated with the cardiopulmonary instructor who will ensure with the users that the laboratory work is not disturbed. Visitors are not allowed into the laboratory premises without wearing appropriate safety equipment.

5.1.11 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.

5.1.12 The disposal of 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 PERFORM SOP PC-SOP-GA-002 “Handling of Biological Materials at PERFORM”.

5.1.13 In case of accidents and incidents, a report shall be prepared following the procedures outlined in the PC-SOP-GA-009 “Emergency Response Procedures at PERFORM”.

5.1.14 The last authorized laboratory user to leave the CP Suite at the end of the operating hours must ensure that:

• The equipment they were using is switched off, unless there is a notice pasted near the power switch to indicate that it should be turned on

• The entrance door is closed.

NOTE: PPE worn inside the lab should not be worn in public areas since all contaminated, potentially contaminated, or the perception of potentially contaminated protective clothing and equipment beyond the lab may create a hazard or project a careless image to both colleagues and visitors.

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5.2 Laboratory equipment maintenance

Laboratory equipment must be inspected and maintained by a qualified person according to the manufacturer’s specifications. The frequency of the inspection depends on the hazard posed by the equipment, the manufacturer’s instructions, or as required by regulations. It is the cardiopulmonary instructor’s decision to remove a piece of equipment from active use. Records of the maintenance must be kept on file by the responsible person and be available at all times.

5.2.1 Electrical equipment and apparatus

5.2.1.1 Make every effort to keep the assessment area clear from any cables, wires or any other material that can pose a risk of tripping.

NOTE: Only persons experienced in electrical maintenance and repair may perform these tasks. Extension cords must not be used for permanent installations. Contact the cardiopulmonary instructor at 4009 to request for an electrical maintenance representative to install or relocate outlets in close proximity to the equipment.

5.2.2 Compressed gas cylinders

All compressed gases have potential health and safety hazards related to the chemical properties of the gas, as well as pressure hazards. Take precautions to protect personnel from these potential hazards.

5.2.2.1 All gas cylinders, empty or full, must be properly secured so they cannot be knocked over. Cylinders with safety caps in place may be secured together. All others must be secured separately;

5.2.2.2 Compressed gas cylinders should be transported capped and chained on appropriate carts;

5.2.2.3 Always use the appropriate regulator for the gas being used. The regulator should be inspected each time before use, as recommended by the manufacturer.

5.2.2.4 Compressed gas cylinders have a finite shelf life. Ensure cylinders are regularly inspected. Any cylinder that is corroded or has damaged valve components should be returned to the supplier. All cylinders older than ten years should be returned to the manufacturer. Manufacturers of corrosive gases recommend that cylinders of corrosives be replaced every six months to guard against valve failure.

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NOTE: Failure of either the diaphragm or the regulator can occur unexpectedly. Be prepared! When opening the main valve of a compressed gas cylinder do not stand over the main valve or behind or in front of the pressure gauge(s). These are the most probable locations for failure.

5.2.3 Equipment cleaning and sterilization

5.2.3.1 It will be the user’s responsibility to clean and sterilize the respiratory and exercise equipment after its use, following the procedures outlined in the below documents: • PC-POD-CP-001 “Maintenance and Cleaning of Respiratory Equipment”; • PC-POD-CP-002 “Cleaning, Maintenance, and Calibration Procedures for

Automatic and Manual Aneroid Sphygmomanometers”;

6. Emergency Procedures

Procedures for responding to alarms, power outages, minor and major medical emergencies are to be followed as outlined in APPENDIX I and as detailed further in PC-SOP-GA-009 “Emergency Response Procedures at PERFORM”.

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APPENDIX 1

Emergency Procedures

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PERFORM CENTRE RESPONDING TO AN EMERGENCY

Fire Alarm and

Evacuation

Power Outage

Minor Medical Emergency

(non-life threatening)

Major Medical Emergency

(life-threatening) 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.

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.

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.

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.

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North side

Evacuation Directions from CP Suite # S1.167-1.172

Gathering point at fence bordering Sherbrooke Street

East-side

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APPENDIX 11

Training checklist

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Cardiopulmonary training checklist

Cardiopulmonary suite orientation: Yes No Not Applicable Cleaning and sterilization procedures: Yes No Not Applicable WHMIS (Workplace Hazardous Materials Information System) training from Concordia University EH&S Department: Yes No Not Applicable Biosafety/blood safety training from Concordia University EH&S Department: Yes No Not Applicable Radiation safety training from Concordia University EH&S Department: Yes No Not Applicable Training and review of cardiopulmonary specific procedural operation documents (POD) for equipment, or processes that pertain to research, education or community programs/projects, also including the following: CardiO2Ultima system Yes No Not Applicable Breezesuite software Yes No Not Applicable ECG system Yes No Not Applicable Lode upright cycle Yes No Not Applicable Plethysmograph Yes No Not Applicable Treadmill, Trackmaster Yes No Not Applicable Automated BP device Yes No Not Applicable Ambulo 2400 system Yes No Not Applicable Holter-ambulatory ECG Yes No Not Applicable

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Excalibur sport bike Yes No Not Applicable Emergency response Yes No Not Applicable Treadmill, Cosmos H/P Yes No Not Applicable Angio arm ergometer Yes No Not Applicable K4b2-Cosmed Yes No Not Applicable Stadiometer Yes No Not Applicable Comments: Trainee Name:

Signature Date of training

completion Training given by:

Signature Date

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APPENDIX 111

SOP training record form

PC-SOP-CP-001-v01

SOP Title

Cardiopulmonary Suite Access, Use, Safety, and Training of Personnel (S1.167-1.172):

SOP Code

Ownership Document type Area SOP Number Version

PC SOP CP 001 01 Training Record

Full Name

Institution

Contact (email or phone number)

Signature

Sign here (trainee) Date

Sign here (cardiopulmonary instructor) Date