Policies and Procedures

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Policies and Procedures Manual

These documents comprise the official policies and procedures for the MEG lab.

  • MEG Core Facility
MISSION STATEMENT


The Magnetoencephalography (MEG) Core Facility is a multi-user facility dedicated to providing resources for use by NIH Institutes and the Clinical Center. The mission of the MEG Core Facility is to provide all necessary support for Principal Investigators (PI) conducting research to successfully design and implement an MEG based project. This will usually include detailed experimental design discussion, software and hardware design and testing, training in data collection and system instruction, signal processing and data analysis.


VISION STATEMENT


The MEG Core Facility is dedicated to offering and providing state-of-the-art services. We will maintain excellence in the performance of magnetoencephalography research and will be recognized as a preeminent center for the performance of biomedical imaging research.


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Operations(1.00)

Hours of Operation

National Institute of Mental Health

Subject:
MEG Core Facility
Hours of Operation
Policy No. 1.00

Date: 1/03
Revised 9/03; 6/06; 7/07; 10/08; 8/09; 1/12; 1/14; 1/15

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: The MEG Core Facility hours of operation are from 9:00 a.m. to 5:00 p.m. Monday thru Friday.


1) Normal hours of operations 9:00-5:00 pm Monday - Friday. The MEG Core Facility staff will be available to assist users during normal hours of operation.
2) Users may schedule scans for after hours provided they have received training and are capable of operating MEG equipment in accordance with MEG policies and procedures.
After hours use authorization must be obtained from MEG Core staff.


Laboratory Access

National Institute of Mental Health

Subject:
MEG Core Facility
Laboratory Access
Policy No. 1.05

Date: 1/03
Revised 9/03; 6/06; 7/07; 10/08; 1/12; 1/14; 1/15; 2/18

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: The MEG Lab keyless entry system will be utilized for MEG lab access before, during or after normal lab hours.


1) MEG Users will be given the MEG Lab keyless entry code during the MEG Orientation Training class.
2) During Normal Hours of Operations- the MEG Lab may or may not be locked, however, if locked access may be gained / the door can be unlocked by using the access code.
3) After Normal Hours of Operations and on the weekends- the MEG Lab will be locked, however, access can be gained by using the keyless entry system.
4) All equipment, except for all computers (acquisition and workstation), must be powered off upon departure.
5) It will be the responsibility of the user to make sure the lab is locked upon departure.


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Scheduling (2.00)

Scheduling

National Institute of Mental Health

Subject:
MEG Core Facility
Scheduling Procedures
Policy No. 2.00

Date: 1/03
Revised 9/03; 6/06; 7/07; 10/08; 1/12; 1/14; 1/15; 2/18

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: MEG scan time will be requested and scheduled electronically via the web-based calendar at: http://kurage.nimh.nih.gov/cal/. Scan time will be scheduled on a first-come -first served basis. All requests must be approved before going "live" on the public calendar. All unapproved time requests will appear in red. When a MEG schedule notification is received, an MEG administrator will be responsible for approving or denying the request. Users will auto matically receive an email message notifying them when their time has been approved.


Procedure:

I. Requesting Time -
1. Click on Login location near the bottom of the MEG Schedule/Calendar.
2. Enter “Username” and “Password”.
3. Click on Login.
4. On the calendar - Click on the  at the day and time desired.
5. Enter the “Add Entry” form information –
a. Investigator’s Name - enter the last name of the PI / last name of the person who is going to run the scan (acquisition computer). For example - BERMAN / J. Mitchell. In this case Dr. Berman is the PI and Judy Mitchell is running the scan.
b. Description of experiment – provide a simple description
c. Comments - Use this field to enter any private comments, subject name / phone number or MIS number. Information in this box will not appear on the published calendar. Important: ::::This box is for confidential information.
d. Sensor position – Sitting or Supine.
e. EEG electrodes – indicate whether EEG, EOG, EMG electrodes will be used.
f. Date
g. Time - military time.
h. Duration – indicate how much time needed to complete your study. Please allow enough time for any possible delays (set up / prep time, subject late, equipment malfunction, etc.).
i. Hold approval – only use holds if your subject needs to get back with you to confirm the appointment. Appointments can only be held for 2-3 days.
j. ParticipantsDO NOT ALTER THIS FIELD (should always be admin for MEG staff who are doing the scheduling).
k. Repeat Type – if a recurring appointment enter here; however, check with Staff Scientist before scheduling any repeats!
l. Repeat End Date – *for recurring appointments only.
m. Repeat Day (weekly) - *for recurring appointments only.
n. Frequency – for recurring appointments only.
6. Click on “Save”.


II. To Edit or Cancel an Appointment –
a. Click on the login.
b. Enter User Name and Password.
c. Click on the entry to be changed (at the point where it gives the little popup detail description).
d. Click on option: Edit entry, Delete entry, Add to My Calendar, etc.
*Please note: you must be the owner to be able to edit or delete an entry in the schedule.
III. To Refresh the Calendar –
1. Click on My Calendar.



Facility Access Requests

National Institute of Mental Health

Subject:
MEG Core Facility
Facility Access Requests
Policy No. 2.01

Date: 3/03
Revised 9/03; 6/06; 7/07; 10/08; 1/12; 1/14; 1/15; 2/18

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: Each MEG user who wants to schedule subjects for an MEG scan must filled out and electronically submit the MEG Facility Access Request Form (FAF). The Facility Access user account will allow the MEG user to: 1) schedule MEG scans via the MEG Lab scheduling calendar and, 2) access MEG data. The MEG Core Facility website administrator will be responsible for approving and maintaining all facility access requests.



Procedure:

1. A Facility Access Request (FAF) must be submitted electronically to become a MEG Lab user. The form may be accessed via the MEG Lab website at: http://kurage.nimh.nih.gov/meglab under User Information  Becoming a User.
2. All the requested information must be provided, such as the protocol #, PI’s last name and the name of the person who be in the MEG Lab running the study. In addition, we must have a cell phone number so that we can contact you in an "emergency".
3. The username will be the user’s last name as entered on the Facility Access Form (FAF).
4. When a Facility Access Request Form is received the accounts administrator will assign an account and issue a temporary password.
5. An email notification of the account name and temporary password will be sent to each applicant.
6. User accounts may not be shared.


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User / Subject Guidelines (3.00)

User Guidelines

National Institute of Mental Health

Subject:
MEG Core Facility
User Guidelines
Policy No. 3.00

Date: 1/03
Reviewed: 6/03; 9/03; 6/06; 7/07; 10/08; 1/12; 1/14; 1/15; Revised: 2/18

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: All investigators interested in conducting MEG scans / research studies are required to meet all the requirements of the Institutional Review Board (IRB) and adhere to MEG Core Facility policies and procedures as outlined below.


Procedure:

I. Becoming a User
1. Protocol Approval
a. User groups are required to have an IRB approved protocol with a description of the intended MEG research before a user account ID or scanning time can be assigned.


2. User Accounts
a. A Facility Access Request must be filled out electronically (http://kurage.nimh.nih.gov/meglab ) to establish a user account. Filling out this request will initiate the process of establishing a user account ID and password.
b. The account ID and password will give users access to the scheduling calendar and provide access to the MEG Core Facility data storage system. All requests must be sent electronically.
d. The account ID information will be emailed to the email address provided in the Facility Access Request Form, generally within 24 hours, if not call the Staff Engineer at 301/402-2362.


3. MEG Orientation
a. Users must schedule / attend an informal MEG orientation to become familiar with the lab operations and equipment.
b. Established users with new protocols will be required to complete a “new” Facility Access Request for each new protocol indicating the new protocol number.


II. Initiating a MEG Study
1. Study Design Review
a. Users must provide the director and/or staff scientist with a description of the research study design including information regarding setup requirements, software and equipment needs.
2. System Testing / Task Setup
a. Users must schedule a time to test their task / paradigm, equipment, software, etc. When scheduling indicate in the scheduling module that the appointment is for a “system test”.
b. Indicate whether programming or scripting support will be needed for the stimulus program.
c. Also, indicate whether technical support is needed – i.e., training or assistance with EEG/EP electrode placement or setup. If you have a specific electrode setup or placement and require MEG Core staff assistance you must provide a detailed description of your setup.
3. Pilot Studies
a. Most protocols will require a pilot study to test equipment, paradigms / programs and refine procedures with a test subject. Users must provide their own volunteer subject; if this is an external volunteer, he/she must be consented according to IRB guidelines.
b. You must schedule time for the pilot study via the web calendar. Please indicate in the description that time is being requested for a “pilot study”.


4. User Training
a. There is a three-step training program specifically designed so that users can acquire practical experience. The user is expected to become competent in performing all aspects of MEGs on their own subjects. MEG Core staff is available to provide training and technical assistance.
1. Instruction – (without a subject) MEG setup instructions and equipment operation.
2. Observation – (with a subject) instructions and observation of MEG setup and scan.
3. Practicum – hands on training session running a subject during a MEG scan.
b. User training must be scheduled via the web-based calendar. You must indicate in the description that this is MEG Training – Instruction, MEG Training-Observation, or MEG Training-Practicum. MEG staff will assist users during all phases of this training.


5. Scheduling Scan Time
a. Scan time must be requested electronically via the web-based calendar at http://kurage.nimh.nih.gov/cal/. Currently scan time is scheduled on a first-come-first-served basis.
b. To Request Time – Enter User Name and Password; click on Login; enter form information; save.
c. Approvals - All requests must be approved before they will go “live” on the public calendar. You will receive an email message notifying you that your time has been approved. All unapproved requests will appear in red.
d. To Edit or Cancel an Appointment –
• Enter User Name and Password; click on Login;
• Click on the entry to be changed (at the point where it gives the little popup detail description);
• Select an option: Edit entry, Delete entry, Add to My Calendar, etc.
• *Please note: you must be the owner to be able to edit or delete an entry in the schedule.
e. To Update Calendar - click on My Calendar.
f. Certain times in the schedule will be reserved for maintenance / quality assurance.
g. Allow about 2 hrs per subject for MEG (depending upon the study) and about 3 hrs for a MEG with EEG.


III. User Log
Users MUST document any scan that they perform in the User Log Book. If a subject was set up for the MEG but the scan was not able to be performed – that scan must still be logged in the User Log Book with a comment explaining why the study was not performed.
Subject information and all other pertinent information must be filled out in the log book, i.e., date, PI name, operator’s initials, protocol #, subject’s initials, MIS -#, and the gantry position. Do not leave any blank entries.


IV. Lab Safety
1. Equipment Operation - When performing a MEG study there must be at least two persons assisting with a study; one person must be capable of operating the equipment.
2. Subject Safety – a subject must never be left in the MSR. The subject must be observed at all times and must never be left alone in the MSR for any reason. Two persons must be available for assistance if the subject were suddenly to take ill or if something unexpected were to happen.
3. Chair / Table Safety – Care should be taken when raising the chair / table when you have a subject sitting or supine in the gantry. In order to avoid injury, it is important to understand how to operate the chair and table. Operating instructions are in the MEG Policy & Procedures Manual and the CTF Users Manual. The chair has a 300 lbs. maximum weight limit and if using the bed the weight limit is around 250 lbs. maximum.
4. Gantry Safety – It is important to understand how to operate the gantry. Never adjust the gantry (tilt or angle) when a subject is seated in the chair or lying on the table. Instructions are available in the MEG Policy & Procedures Manual and the CTF User’s Manual.
5. If a medical emergency occurs call X111. For Fire or Police call 9111. For any other emergency contact the director or staff scientist for assistance at the phone numbers posted in the lab.


V. Process Improvement / Variance Reporting
1. Process Improvement / User Feedback – Users may make suggestions or give feedback to the MEG staff via the Variance Process Improvement Report. Feedback may also be provided via the MEG Discussion List at MEG_DISCUSSION@LIST.NIH.GOV.
2. Variance Reporting – Users are responsible for reporting complications, incidents, or problems that occur involving the facility via the Variance Process Improvement Report.
3. Equipment Failure -Users are also responsible for reporting any equipment failure or any equipment that may not be working properly via the Variance Process Improvement Report.
4. Broken Equipment - Any equipment that is inoperable or broken should be tagged with an Out of Service / Do Not Use sticker indicating the date and time taken out of service. Fill out the sticker including the name of the person making the report, phone number and a brief description of the problem.
5. All non-urgent communications will be reported using the Variance / Process Improvement Report.


VI. Magnetically Shielded Room (MSR) Guidelines
There are no known risks associated with MEG/EEG recordings. Although wearing metal objects while in the MSR (Magnetically Shielded Room) is not harmful to the individual, bringing metal objects in the MSR can result in a poor quality / uninterruptible recording. In addition, bringing magnetized objects into the MSR can cause trapped flux in the SQUIDS which can lead to long and expensive service to fix causing obvious interruptions and scheduling delays. Thus, we have established these guidelines:
1. Subjects should not bring any metal objects inside the MSR. Any subject entering the MSR must first “de-metal” (remove any metal objects; empty pockets; remove jewelry, hairclips, pens, clipboards etc.). These include belts, keys, watches, rings/earrings, necklaces, coins, eyeglasses and pieces of clothing with metal parts such as bras with under wires or bras with metal adjustment rings.
2. No one (not subjects / nor MEG Users) should bring electrical equipment inside the MSR. Objects such as cell phones, pagers, cameras, flashlights, or any other electrical equipment are strictly forbidden.
3. Magnets and anything magnetized is never allowed inside the MSR by anyone.
4. No one should wear shoes inside the MSR. To prevent any metal or magnetic dust from getting into the MSR shoes must be removed before entering the MSR.
5. Any “unapproved” equipment should not be brought into the MSR. Any “special” equipment must be approved by the director or staff scientist prior to its use.
6. Do not use small metal objects (i.e., staples, paper clips) around the MSR.
7. NO equipment will be left in the MSR other than the equipment that belongs in the MSR.


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User Subject Guidelines

National Institute of Mental Health

Subject:
MEG Core Facility
Subject Guidelines
Policy No. 3.20

Date: 1/03
Revised: 9/03; 6/06; 7/07; 10/08; 1/12; Reviewed: 1/15; Revised: 2/18

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: MEG normal control / volunteer subject selection / screening will conform with MEG best practices criteria. In addition, MEG guidelines will be consistent with the policy and procedures established by the NIH and the IRB.


Procedure:

1. Subject Registration
a. All subjects participating in MEG studies are required to have a valid medical record number (Medical Information System /MIS #).
b. It will be the responsibility of the principal investigator (PI) to make sure that all outpatients and control subjects have gone through the appropriate registration process and have a valid MIS#.
c. A doctor’s order is not required for an MEG scan but a progress note must be placed in the subject’s chart indicating the nature of the scan performed, the date, time, and protocol number. The patient’s condition and general performance should also be noted. The progress must also be signed by the appropriate personnel.


2. Consent Forms
a. An IRB approved consent form must be signed by all subjects prior to participating in any MEG research study.
b. Investigators are required to satisfy all Clinical Center documentation requirements.
c. It will be the responsibility of the PI to assure that subjects have signed the appropriate consent form.


3. Subject Pre-Screening
a. Although MEG/EEG poses no known risk to subjects, certain physical conditions may make subjects ineligible to participate in scanning. Some subjects will be ruled out for participation in scanning due to factors involving metallic foreign bodies which may prevent obtaining artifact free data.
b. It will be the responsibility of the PI to pre-screen subjects for the below listed contraindications during the selection process.
Conditions That Will Rule Out a Subject:
• Cardiac pacemaker / Cardiac or neural defibrillators
• Metal fragments in the eyes
• Metal plates, pins or bolts in head
• Any magnetic implantation / implantations made from iron (ferrous products)
An Additional Consideration Which Will Rule Out a Subject:
• Head size greater than 60 cm: if a subject’s head is too large to fit in the helmet


4. Subject Screening
a. Investigators may use the MEG Screening Questionnaire and/or Handedness Form as a subject evaluation / screening tool.
b. All MEG subjects should be screened for the following items which may cause recording artifact.
Conditions That May Rule Out a Subject:
• Surgical aneurysm clips
• Shrapnel
• Intra-orbital metallic structures
• Neurostimulator
• Implanted pumps (i.e., Insulin pumps)
• Steel pins from root canals; a permanent retainer
• Ear implants (certain cochlear implants)
• Metal rods, plates or screws in the body or mouth
• Previous surgery (if metal was left in the body)
• Hearing aids (should be removed before scanning)
• Braces (causes severe artifact)
• Tattoos (may have metallic paint)
• Piercings (may have metallic ink)
Other Considerations Which May Rule Out a Subject:
• Head size: if a subject’s head is too fit in the helmet
• Movement disorders (i.e., ticks, restless legs, etc., any condition that may cause excessive movement)
• Vision / Hearing problems
• Problems using response devices


c. The confidentially of the MEG Subject Screening Questionnaires and Handedness Forms will be the primary responsibility of the study’s principal investigator.


5. Subject Instructions
a. Users/PI’s are responsible for giving subjects instructions prior to any scheduled procedure.
b. Subjects should be informed not to wear these items:
• Bras with underwires
• Makeup (mascara, eye liner, eye shadow)
• Clothing containing metallic (shiny) threads or glitter
• Metal on clothing (i.e., metal buttons, snaps or trimming)
c. Subjects should be informed that metallic/magnetic items should not be taken into the Magnetically Shielded Room (MSR). These include such items as:
• Belts
• Keys
• Watches
• Coins
• Eyeglasses
•Cell phones
• Pagers
• Credit Cards
• Small metal objects such as hair pins, paper clips, safety pins, etc.
• Shoes (may have metallic dust particles on them)
d. It is the responsibility of the PI to inform subjects that if they arrive unprepared i.e., have metallic/magnetic parts on their clothing that cannot be easily removed, they may be asked to change into non-magnetic clothing which will be provided by staff.
e. If there is any question about whether an object is magnetic, the object is not taken inside the MSR.


MEG / EEG (4.00)

National Institute of Mental Health

Subject:
MEG Core Facility
MEG / EEG
Policy No. 4.00

Date: 1/03
Revised: 9/03; 6/06; 8/07; 10/08; 1/12; 2/18

Recommended By:
MEG Core Facility Staff

Distribution: MEG Core Facility

Policy: All subjects/patients will be up set for MEG according to standardized procedures in accordance with manufacturer’s specifications.

Procedure:

1. Head Size / Fit Test
a. Determine head size by measuring the subject’s head. The Gantry head limits are:


Nasion-Inion Preauricular Point to
Preauricular Point
Circumference
< 40 cm < 40 cm < 59 cm


b. Determine fit by placing the MEG helmet along with a protective cap over the subject’s head.
2. Fiducial Points/Head Coil Placements
*If subject has had previous digital pictures of the fiducial points retrieve images and match placement.
a. Place a small black dot near the nasion (indentation between the forehead and the nose); between the eyebrows midline.
b. Place a small black dot at the left and right preauricular points centered (about 1.5Cm) in front of the tragus. This should be measured on a straight line from the tip of the tragus to the outer canthus for accuracy.
c. Take a digital picture of these locations, download and print Place in subject’s MEG file for future reference.
d. Attach a small (MEG) Adhesive Washers to each head localization coil.
e. Attach head localization coils at the fiducial marks. *Make sure the marks line up with the center of the head coils. Place the:
f. Place tape over the coil and the cable to secure.


MEG HEAD COIL PLACEMENTS
RIGHT
PRE-AURICULAR POINT
NASION LEFT
PRE-AURICULAR POINT
Red Yellow Blue


References:

1. NIMH MEG Core Facility Data Tutorial Manual
2. MEG/EEG Operation and Technical Reference Manuals, CTF Systems Inc.


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Magnetically Shielded Room (MSR) & Subject Support (5.00)

______________________________________________________________________________________________________________________________


Stimulus / Response / Monitoring Equipment (6.00)

______________________________________________________________________________________________________________________________


Data Acquisition / Data Analysis (7.00)

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Infection Prevention / Control (9.00)

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Quality Assurance / Risk Management (10.00)

______________________________________________________________________________________________________________________________


Training & Education (11.00)

______________________________________________________________________________________________________________________________


Compliance (12.00)

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Quality Assurance Manual

This manual contains information on the MEG Core Facility Quality Assurance - Quality Improvement / Risk Management Program. These programs monitor and evaluate the quality of services provided in order to pursue opportunities for improvement. This manual is currently under development.

Tutorials

Here is some tutorial documentation that has been compiled as a complement to the information available on the website. Some of the topics are covered in more depth in these manuals, although the information on the website may be more current.

    MEG Data Acquisition Tutorial (last updated 8/22/03), update coming soon)
    MEG Data Acquisition Tutorial (last updated 8/22/03), update coming soon)

    MEG Data Analysis Tutorial (last updated 8/13/03, update coming soon)
    MEG Data Analysis Tutorial (last updated 8/13/03, update coming soon)

How To Instructions

These are instructions or handouts which cover various different topics pertinent to the performance of MEG scans and/or data analysis.

*   MEG Fiducial Placement Instructions
*   MEG Fiducial Placement Instructions

Octave Class

Tom gave a short tutorial on switching from Matlab to Octave. Here are the class notes: Octave class (MS PowerPoint Presentation) This reflects versions 2.9.10 of Octave. Also, here are two sample scripts:

*   anything.m
*   mkmesh.m

Miscellaneous Documentation

  • SensLayout-275 — a color picture showing the sensor names and relative locations (ps).
  • SensLayout-275 - a color picture showing the sensor names and relative locations (pdf).