Re-opening guidelines for the F.M. Kirby Center Human scanning MRI facility. Locations: 1) Kennedy Krieger Institute (KKI), 707 N. Broadway, KKI lobby level. Rms. G25 and G26 (Fig. 1) 2) Kennedy Krieger Institute (KKI), 716 N. Broadway facility (basement, Fig. 2) Users: Johns Hopkins University (JHU) and KKI staff and faculty Access: KKI 707 building is connected to JHU via the JHU tunnel system Hours: 9am – 6pm. Off-hour booking (evening and weekends) possible for qualified users. Equipment and location details: a) MR1: 3 Tesla Philips scanner, Rm G25, surrounded by dotted blue line in Fig. 1

Control Room: 307 sf; Scan Room: 507 sf; Preparation Room: 106 sf; waiting + entrance ~200 sf; Mock scan area (orange area in Fig. 1) ~ 300 sf. Office area has separate access and the door between the scan and office areas will remain closed, except for emergency access. Offices will be entered through the back door only.

b) MR2: 3 Tesla Philips scanner, Rm G26, surrounded by solid blue line in Fig. 1 Control Room: 272 sf; Scan Room: 460 sf; Preparation Room: 108 sf; waiting + entrance ~150 sf; Waiting

area ~213 sf; c) 7 Tesla Philips scanner (Basement of 716 Bldg, scan area surrounded by dotted blue line Fig. 2)

Control Room + Entrance: 550 sf; Scan Room + RF porch: 503 sf; Preparation Room: 117 sf; Waiting area ~213 sf; Student/postdoc area (7 desks); 447 sf. Accessible only by walking through scanner control Rm.

Essential Personnel. Personnel to contact first for daily management issues in red. Since this is an interinstitutional facility, some staff have two appointments (Primary listed first). Center Director: Peter van Zijl, Ph.D. JHU faculty (Professor) and KKI staff Email: vanzijl@kennedykrieger.org; phone: 410-979-3466 Facility Manager: Jame Pekar, Ph.D. KKI staff, JHU faculty appointment (Professor) Email: jpekar@kennedykrieger.org; phone: (410) 491-3333 Chief MRI Tech: Terri Brawner. KKI staff Email: brawner@kennedykrieger.org Cell phone: 410-925-2852 MRI technical expert: Joe Gillen, B.S. JHU faculty (Research Associate) and KKI staff Email: jgillen@mri.jhu.edu Cell phone: (443) 928-2007 MRI technologist: Kathleen Kahl Email: kahl@kennedykrieger.org; Cell phone: (443) 622-9189 MRI technologist: Ivana Kusevic Email: kusevic@kennedykrieger.org; Cell phone: (410) 905-7806 Administrative Assistant: Heather Mackey Email: mackey@kennedykrieger.org; Office: (443) 923-9500; Cell: (410) 963-0879 Order of contact for human MRI scanners: Practical issues with scanning: Ms. Brawner. Technical support: Mr. Gillen. General issues: Dr. Pekar.

General Guidelines for the staff and users • These guidelines are intended to provide guidance for all F.M. Kirby Center staff members and users of the

F.M. Kirby Center human scanner facilities. They may be revised according to circumstances. • Nothing in these guidelines should be construed as circumventing guidance from JHU and KKI administration

or state or city regulations. • Everyone is expected to be familiar with the current guidelines and COVID-19 policies for JHU and KKI. • Remote working is expected of all personnel when possible. Visits to the facility should be limited only to

activities essential for research scanning, equipment maintenance, monitoring, or cleaning. • Booking will only allowed when the user provides us with evidence that both JHU and the IRB have approved

resumption of your research protocol. Please forward these approvals to Dr. James Pekar, who will copy the other Center staff.

Specific Guidelines for the staff and users present at the facility 1) The scan area is defined as including the areas surrounded by the solid blue line for MR2, the dotted blue

lines for MR1 and the 7 Tesla area. The scan room is the room containing the magnet (Figs. 1 and 2). a) Face masks must always be worn by all subjects, users and staff when in the scan area. Only exception

is when the subject goes in the scanner, at which point he/she will be requested to take off the mask to avoid hyperventilation during the scan, which will for instance affect functional MRI data. Users must ensure that their subjects and group members have a mask with no metallic components before they arrive at the Center.

b) MRI techs and other center personnel should at all times wear a lab coat when there are users or subjects in the scan area. MRI techs should have a spare lab coat and wash their coats at least weekly.

2) The number of people allowed in the scan area simultaneously will be strictly limited. The maximum number of people in the scan area will be determined by the total scan area and the 400 sf rule (see below in space occupancy section). Only those individuals who are essential for data collection and subject safety will be present.

3) Social distancing, remaining 6 feet apart must be observed at all times, unless it is needed to perform tasks together, e.g., placing the subject in the magnet. Amount of time spent in close proximity will be minimized by use of verbal instructions whenever possible to enable the subject to do things independently, such as insert ear plugs or get comfortably positioned on the scanner bed. The informed consent and safety screening processes (except for magnetic screening, which is a Center safety responsibility that needs to be done on-site) must have been done before coming to the scanning area. Movement around the scan area must be planned and communicated between individuals to avoid coming within 6 feet of each other when navigating to and from the bathroom or other areas. We realize that, for human scanning, needed procedures sometimes make it impossible to adhere to the 6-feet social distance guideline, e.g. when positioning the subject in the scanner. Whenever two or more people are temporarily needed to be within 6 feet from each other, face-shields must be worn. These will be provided and kept clean by the Center. The only exception will be for parent and child.

4) Keeping the facilities clean and hygienic. a) At the end of each imaging session, ALL used surfaces will be disinfected:

- Tables, benches, chair arm rests, surfaces and computer keyboards (we now have washable keyboard covers) in the scan control room, waiting area, subject prep area (if used). - The scanner front, bore, and RF coil and all other scan room areas that have been in proximity of the user. Paper roll will be used to cover the scanner bed and replaced for each subject.

b) Cleaning procedures will consist of either using disinfectant wipes or spraying/applying disinfectant directly to new paper towel to minimize aerosol generation of disinfectant (i.e. 70% ethanol solution); wiping working and high contact surfaces as described below. Stations containing 70% ethanol and paper towels will be available at the individual Center areas.

c) Door knobs of the Center entrance doors and to the individual scan areas will be cleaned regularly (after every user).

d) Shared surfaces. As a core-facility, there will be shared surfaces and shared equipment. When used during opening hours, these will be cleaned by the MR tech after the user leaves.

e) Before being allowed to use the facilities off hours without a staff technologist, users must be trained

regarding how to clean all use surfaces as stipulated in 6a-d. As a double precaution, the MRI tech will clean all surfaces again at the start of the next work day to assure cleanliness. f) Wash/disinfect hands anytime after you touch shared items, before AND after using the restroom, and when you leave the Center. Do not touch your eyes, nose, or mouth.

Specific guidelines for area entry and exit, space occupancy and its monitoring 5) All scanner entrance areas (MR1, MR2, 7 Tesla) have a magnetic card reader. These will be used to

monitor entry. Everybody (Center personnel and users) except for scan subjects and their companion needs to swipe in to keep track of the facility occupancy. The MRI tech may ask if you swiped in, and if you forgot, may ask you to swipe your card. The MRI tech will keep a list of the persons that do not have a badge and entered so that we can track later if needed due to infection. If people cannot swipe in, the MRI tech or staff person will record their name and time of entry.

6) After every user, the MRI tech or the responsible staff personnel performing the scan or the off-hour user

will complete a sheet for signing participants out of the scanner area, including time of exit, and this record will be kept.

7) At the end of the day, all lists from point 5 and exit sign-up sheets (point 6) will be stored in safe drawers in

line with HIPAA guidelines. 8) Details for the different scan areas: a) MR2 is an isolated scan area and easy to monitor (surrounded by blue solid line in Fig. 1). The total area

for MR2 including hallway is about 1100 sf. Maximum occupancy will therefore be 3. Preferable occupancy 2.

b) To isolate the scan area for MR1 (surrounded by blue dotted line in Fig. 1), the office area will be closed off. Office users need to enter through the back door of the office area using a key, avoiding the scan area. Separate office guidelines will be made for Center personnel. The MRI techs and some Center staff have keys for the door separating the offices from the scan area, but these will only be used if needed (e.g. to make a copy of a consent form) and locked again afterwards. If Center staff will go to the scanner as a user, they will need to walk around and use the card key. The reason is for later tracking of presence in case of an infection. The total area for MR1 including mock scanner and hallway is about 1600 sf. Maximum occupancy will therefore be 4. Preferable occupancy 2.

c) The mock scanner (solid orange line in Fig. 1) is part of the MR1 scan area. Either MR1 or the mock scanner will be booked and used. Not both scanners at the same time. A staff person or trained user will also need to be present for mock scanning to assure proper cleaning.

d) The total area for the 7 Tesla scanner including hallway and waiting area is about 1600 sf. Maximum occupancy will therefore be 4. Preferable occupancy 2. The 7 Tesla office area (see Fig. 2) can be entered only via the waiting area, entrance and control room. As such, personnel in the office area will need to communicate with the MRI techs when it is possible to cross the scanner area. A daily office schedule adhering to JHU and KKI guidelines will be made for the students and fellows in the 7 Tesla office area.

9) Unless required for assistance, only one staff member (in general the MRI tech, but sometimes an MR

physics expert) should be present in the scan area at a time. Together with the magnetic card reader, this staff member will also serve as the occupancy monitor. A personnel schedule will be made according to the booking of the scanners

Scheduling 10) A daily schedule for scanner use will be made by facility personnel based on the on-line scanner bookings.

Bookings will be restricted to allow sufficient time between users for cleaning (at least 15 min after the scan) and for magnetic safety screening and getting instructions at least 15 min before the scan. Thus, to limit the total number of people within the facility, the typical 1 hr booking slots will now be 1.5 hrs. When booking, the user should therefore have at least 30 min between the previous and following bookings. The scheduling system will allow for this.

11) The final schedule will be made available latest 24 hours before planned use and posted on-line so the

users can plan their studies. Times may have been adjusted by Center personnel in order to accommodate the time needed for cleaning and magnetic safety screening, so the users should therefore always check the schedule carefully the day before use. The MRI tech or staff person responsible for the scan will be listed for the particular scanner. In case of issues, communicate with Center staff listed. Communicate with the staff before coming over to the Center.

12) When booking the user should also indicate the number of investigators that will be needed in addition to

the subject to be scanned and whether additional people will also be present (parent or translator). The scheduling system will require for this to be done. Users need to discuss with Center personnel well in advance of scheduled use, ways to minimize the number of people in the scan area so as not to exceed the stated maximum capacity of the space (e.g. whether personnel can take over the task for the second person). Timely communication is key.

13) When booking, the user should provide a cell phone number so that the scan area monitor can contact

them. The scheduling system will require for this to be done. 14) No users should enter the facility without permission from the person monitoring the facility, to ensure that

previous users have left and the area has been cleaned before entry. If previous permission has been granted for use when there is no staff person monitoring the facility, e.g. for early or late experiments outside work hours, users should directly confirm that no one is in the facility before entering.

15) If experiments run over time, the next user will be notified to wait. This will be done as timely as possible

and this user cannot enter the facility until the previous user has left and the facility area has been cleaned. The users should not spontaneously go to the Center but wait at their point of origin until the monitor gives permission to come over. All users should therefore provide a cell phone number when booking. Do not enter signs (see signage) will be placed at the entrance when experiments are ongoing.

Scan procedures 16) The subject and accompanying person(s) will be allowed to enter the scan area after having confirmed

permission with the MRI tech for that scan area. 17) The staff member (generally but not always the MRI tech) will be wearing a face shield and provide clean

face shields to the persons accompanying the subject. 18) While in the waiting area, the subject will again be asked COVID-19 screening questions and when

approved undergo magnetic screening. Informed written consent should have been taken previously by a member of the study team before entering the scan area.

19) When approved for scanning, the subject will be asked to remove all magnetic material from their body and store it in the safety closets at the scan area entrance, which can be locked with a non-magnetic key that the subject can keep with him/her inside the magnet.

20) The minimum number of persons, but always within the maximum limits imposed, will enter the scan area. This number will ultimately be decided by

a) the needs of the subject. E.g. A child may need a parent present. An elderly subject may feel more secure with a companion. A translator may be needed.

b) The number of people needed by the investigator to run a successful study, e.g. person in addition to the MRI tech or staff person to run any ancillary equipment (Stimulus, eye tracking, etc).

21) The staff member (generally but not always the MRI tech) will explain the scanning procedures and guide the subject into the scan room. Unless the protocol demands in-room explanation of procedures by an investigative team member, no investigator may enter the scan room. If needed, one accompanying person may enter the scan room (e.g. see 20a above). All instruction that can be done remotely, must be done remotely.

22) The staff member (generally but not always the MRI tech), wearing gloves, will place the subject on the scanner table. At this point, the subject will remove the face mask and preferably keep it on the scanner, e.g. clipped (nonmagnetically) to the subject’s clothes. Alternatively, the staff person will place it on a counter next to the magnet. The subject will then be positioned within the head coil or another coil will be placed on the subject. The table will then be moved into the scanner using the scanner guidance system. The staff member will then leave the room, remove and dispose of the gloves, and close the scan room door and communicate with the subject through the intercom.

23) After the scan is completed, the staff member will enter the scan room wearing fresh gloves. The table will be guided automatically out of the scanner and the staff member will remove the coil(s) and instruct the subject to put their face mask back on. For children, the parent may help put the mask on. The subject will then be guided out of the scan room.

24) Once all study aspects have been completed, the subject and investigators will leave the area and the staff will clean all used areas as indicated above in section 4.

25) The staff member will call the next user with the appropriate time to come to the scan area. Special procedures for large animal studies 26) Some center users study large animals, which are always brought in through the Center back door in the

office area to avoid being seen by children and visitors in the KKI lobby. There have been only a few of these studies per year. These studies will now be planned after 5pm and the office area will be emptied beforehand. All procedures listed above, including cleaning, will be followed for these studies, including all personnel being asked to swipe into the card reader.

Procedures for COVID-19 Symptom detection and handling. 27) Before coming to Center, if you are a user check yourself for COVID-19 symptoms: fever, cough, shortness

of breath, or difficulty breathing (see full list of symptoms at: https://www.hopkinsmedicine.org/coronavirus/covid-19-self-checker.html). If a person has any symptoms they are required to stay at home and notify their PI and the Center contact.

28) Users should also ask their study subjects to check for COVID-19 symptoms and instruct them to not come to the Institute if they have symptoms. Before coming to the Center, subjects should always meet with the user or a user representative first, at which point they can be assessed for symptoms through screening questions. In addition, they will be assessed with screening questions and a temperature check upon entering Kennedy Krieger. If there is a concern, for subjects who are not JHU or KKI employees or students, it is the responsibility of the PI to provide such users with information about local resources and instruct subjects or their caregivers to call their own personal physician.

29) If you are experiencing symptoms you should leave work immediately and call the Kennedy Krieger COVID-19 Hotline at 667-205-5100. University employees should also call the COVID hotline at 443-287-8500 for further instructions. Johns Hopkins graduate students should in addition call the University Health Services at 410-955-3250 or Student Health & Wellness at 410-516-8270. You should also notify your PI/supervisor and the Center Chief technologist, Ms. Brawner.

30) Positive Test Contingency. In the event that a user in the Center is positively identified to have COVID-19: a) The individual will leave the Center scan area and institute immediately and go home. Then they will follow points 28 and 29 above.

b) The particular scan area will be cleaned by staff (Item 4 above) prior to continuation of work by the next users. Center users will be called to stay away until green light is given (30 min after cleaning completed). Schedule will be updated.

c) The sick individual and everyone who has been in contact with the individual without wearing a face shield will do a mandatory self-quarantine for 14 days

Reporting 31) There will be zero tolerance for violation of COVID-19 workplace safety guidelines. Noncompliance with

current rules will result in suspended Center access for a period of 1-4 weeks, depending on the severity and frequency of the infraction.

32) Report abuse/problems/concerns to the PI and one of the Center monitors Communication Plan 33) All employees and users will be made aware of the rules and of formal channels to report concerns and/or

mistreatment. This will be done by email and wall posters. 34) Employees and users will not be placed under any pressure by PIs or Center personnel to expose

themselves to potentially hazardous situations (e.g. unsafe working conditions in the Center). Employees and users will be encouraged to voice concerns confidentially to an authority (e.g. Center monitor or the Center Director) who has the ability to act on their behalf to address safety concerns.

35) Employees and users will be made aware to report any abuse/problems/concerns to the PI or one of the Center monitors, or both.

Off-hour use 41) This is discouraged 42) If needed, users will be trained first in all procedures by the MRI techs and make an appointment to do so. Required PPE • Lab coats (Individually assigned) for Center personnel when users are present; Will be laundered weekly. • Face masks when more than one person in the area • Face shields for close proximity tasks; MRI techs and staff will have individual shields with their name. • Gloves for positioning subjects in the magnet and guiding subjects to and from the magnet Material Needs • Lab coats for personnel who do not have one (second coat for MRI techs) • When needed, face-shields will be provided by the Center. We need 10 non-magnetic face shields (i.e. no

ferromagnetic parts) per scan area, so 30 total. • Need cleaning wipes and cleaning spray solution and paper towels. Wipes at each door. • All disinfections will be done with 70% ethanol/paper towel and/or disinfectant wipes. • Paper rolls for covering scanner table • Gloves Scanner area preparation before opening • Counters and desks will be kept empty as much as possible • Toys will be removed from the waiting areas. • Superfluous chairs will be either removed or covered with plastic bags to avoid people using them,

MR2

MR1

offices

MockScanner~ 300 sf

Figure 1: Human MRI research facilities of the F.M. Kirby Research Center at 707 N. Broadway, located at the lobby level of the Kennedy Krieger Institute. The Center contains two state of the art Philips 3 Tesla scanners and a mock scanner to train challenging subjects to feel at ease in the scanner. It is divided in three separate areas: MR1, MR2 and offices; The mock scanner area is a closed of section within the MR1 area. The locations for subject studies are:MR1: Control Room: 307 sf; Scan Room: 507 sf; Prep Room: 106 sf; waiting + entrance ~200 sf;

Hallway: ~200 sf; Mock scan area (orange area) ~ 300 sf.MR2: Control Room: 272 sf; Scan Room: 460 sf; Prep Room: 108 sf; waiting + entrance ~150 sf

Hallway: ~100 sf.Office Area: Will be kept separate from the scan facility and entered through the back door.

Preclinical MR

I PrepRoom106 sf

Entrance + Waiting

Control room307 sf

PrepRoom108 sf

Control room272 sf

Waiting + entrance~150 sf

~200 sf

scan room507 sf

scan room460 sf

Hall~ 200 sf

Hall~ 100sf

Waiting

213 sq ft

Subject

Prep

117 sq ft

Storage

98 sq ft

Utility

86 sq ft

Entrance + Control Room

~ 550 sf

Scan Room

and

RF porch

503 sq ft

Eq

uip

men

t Rm

440 s

qft

Po

std

oc/s

tud

en

t desks (7

)

447 s

qft

Storage

~ 1,350 sq ft

Figure 2: 7 Tesla Human MRI facility of the F.M. Kirby Research Center (FMKRC) at 716 N. Broadway facility (basement level; area F). Scan area is defined by dotted blue line:Waiting room: 213 sf; Entrance + control room: 550 sf; Scan room + RF porch: 503 sf; Subject preparation area: 117 sf; Office area is outside the scan area: postdoc/student desks (7): 447 sf

ALL USERS!!!• Wear face mask• Good hand hygiene• Maintain social distancing• Clean up (disinfect) after done• Any symptoms? Go home!

Kirby Center MRI Facility: MR1 areaBrawner@kennedykrieger.org; Cell phone: (410) 925-2852

jgillen@mri.jhu.edu Cell phone: (443) 928-2007Scanner control room: 443-923-9501

Preferred Occupancy = 2Max Occupancy = 3

Only 1 user group at a time

Do not enter without permissionYes, schedule in advanceYes, wear mask, even when alone

Preferred Occupancy = 2Max Occupancy = 3

Only 1 user group at a time

ALL USERS!!!• Wear face mask• Good hand hygiene• Maintain social distancing• Clean up (disinfect) after done• Any symptoms? Go home!

Do not enter without permissionYes, schedule in advanceYes, wear mask, even when alone

Kirby Center MRI Facility: MR2 areaBrawner@kennedykrieger.org; Cell phone: (410) 925-2852

jgillen@mri.jhu.edu Cell phone: (443) 928-2007Scanner control room: (443) 923-9518

ALL USERS!!!• Wear face mask• Good hand hygiene• Maintain social distancing• Clean up (disinfect) after done• Any symptoms? Go home!

Kirby Center MRI Facility: 7 T areaBrawner@kennedykrieger.org; Cell phone: (410) 925-2852

jgillen@mri.jhu.edu Cell phone: (443) 928-2007Scanner control room: (443) 923-9550

Preferred Occupancy = 2Max Occupancy = 3

Only 1 user group at a time

Do not enter without permissionYes, schedule in advanceYes, wear mask, even when alone