Documentation for Investigators
- CMRR Budget Preparation [doc]
- MRI Data Destination Request [PDF]
- Reasearch Imaging Time Fund Transfers [PDF]
- MR Resource Agreement Worksheet [PDF]
- Medical History [PDF]
- Patient consent form [doc]
Documentation for CMRR Personnel
- CMRR Logo [PNG]
- CMRR Fax [PDF]
- CMRR Letterhead [doc]
- CMRR Time Off [PDF]
- 9.4T Scanner Authorization [PDF]
CMRR Policies and Procedures
Policy 1: Scheduling Protocol for Outpatient Procedures
It is the policy of the Center for MR Research to facilitate the scheduling and processing of MR patients/subjects by establishing a single scheduling policy.
1. All subjects must be scheduled with research staff. Your contacts for scheduling will be:
Michel Flannery, MR Research Technologist
2. All pertinent information should be available to the scheduling contacts. This should include:
A. Project code number from the Center for MR Research.
B. Name, address and telephone number of subject. All persons undergoing an MR procedure will be screened by MR Center staff for contraindications prior to their appointment date; telephone contact will be essential. For preliminary assessment, see reverse side of form.
C. UIC medical record number or relevant medical records outside of UIC. The MR Center staff will not request records from outside institutions.
D. Referring physician/ investigator with telephone contact number or email address if available.
3 Paperwork from the principal investigator with the approved project code number should be sent to the Center 7 days prior to the requested appointment date. This may be faxed to 312 996 8097 or sent by email to the scheduling contacts above.
4. The potential subject will be contacted by either the Research Coordinator or Technologist within 3 business days, for English speaking persons only. Appointments for non-English speaking persons may depend on availability of translators. Upon completion of pre-screening, the subject will be scheduled. Notice to referring physician/investigator will be given via email confirming date and time of appointment.
5. A letter of confirmation with instructional information will be sent to subject if the exam date is more than five days from date of scheduling. A telephone reminder will be made to subject one day prior to scan date.
6. If subject fails pre-screening, an e-mail will be sent to Dr. Thulborn and referring physician/investigator with contraindications outlined.
It is the policy of the Center for MR Research to facilitate Subject understanding by providing written general directions whenever possible to Subjects and Investigators.
1. A copy of a Subject Information sheet is given each investigator for use with his/her subjects. A copy is also available at the Center’s website www.uic.edu/com/mrc for printing.
2. Each subject that is scheduled more than 10 days in advance is sent a copy of the Subject Information sheet prior to their appointment.
Attachment – copy of Subject Information Sheet
Policy 3: Patient Information
It is the policy of the Center for MR Research to facilitate Subject understanding by providing written general directions whenever possible to Subjects and ordering Physicians.
1. A copy of a Patient Information sheet is given each investigator for use with his/her subjects. A copy is also available at the Center’s website www.uic.edu/com/mrc for printing.
2. Each subject that is scheduled more than 10 days in advance is sent a copy of the Patient Information sheet prior to their appointment.
Attachment – copy of Patient Information Sheet
Policy 4: Smoking Regulations
The Center for MR Research recognizes the health and fire hazards of smoking and, therefore, bans smoking on its premises.
The Center for MR Research prohibits smoking and the sale and distribution of all forms of smoking materials on its premises.
This policy applies to everyone on the premises, including but not limited to, staff, patients, visitors, volunteers, and students.
Staff and visitors may smoke in:
1. The open courtyards north of the Campus Health Service (CHS) and UIC Medical Center Hospital;
2. The open courtyard west of the College of Medicine East (CME) Tower;
3. The rear of the Eye and Ear Infirmary (EEI).
Smoking in any other area, including University property surrounding entrances/exits, is subject to visitor sanctions and staff disciplinary action (See Hospital Executive Notice 95-4: UIC Smoking Policy).
Policy 5: Contrast Media Management
The Center for MR Research provides appropriate storage, use, distribution and administration of contrast media.
Procurement and Storage:
All contrast media is recommended and selected by the Director of the Center for MR Research. Contrast media is then ordered by and inventoried by the MR Research Technologist and/or Clinical Research Coordinator. Quantity ordered is determined by the volume of examinations to be performed.
Control and Distribution:
The control and distribution are managed by the MR Research Technologist and/or Clinical Research Coordinator. The contrast media will be maintained in a locked cabinet appropriately designated for this purpose.
The contrast media type, quantity and method of administration is determined and ordered by the Director of the Center for MR Research after reviewing and identifying the patient’s clinical data, and the history obtained from the patient’s medical record.
During and following the contrast media injection, the patient is observed by the technologist and/or clinical research coordinator. If any adverse effects occur, action will be taken consistent with HPMM EC3.01 Patient Occurrence Reporting and TX 2.04 Adverse Drug Reaction (ADR) Reporting.
Policy 6: Informed Consent for Non-Experimental Procedures and Treatment
The Center for MR Research (a) treats all Center for MR Research patients only with their voluntary and informed consent or that of their legally authorized representative and (b) ensures that these consents are appropriately documented.
For the purpose of this policy, the following definitions apply:
An adult is any individual age 18 years or older or any individual recognized as an adult under Illinois law.
Competent is defined as understanding the nature and benefits of one’s action.
An emancipated minor is an individual under 18 years of age and for whom the circuit court of the county where the minor resides orders that the minor is emancipated for some or all purposes. Emancipation by court action may occur when a minor can support himself/herself without parental assistance. The court order shall indicate the specific rights and responsibilities of the emancipated minor. One of these specific rights might be to consent for his or her own medical procedures or treatments. Emancipation of a minor also occurs by marriage.
An emergency is a sudden, unexpected occurrence in which there is an imminent danger to an individual’s life or limb and which demands immediate medical attention.
Informed Consent is the permission granted by the patient (or his or her legally authorized representative) for procedures or treatments after being informed about the possible benefits, possible substantial risks, possible alternative treatments, and the probability of success involved in the procedures or treatments.
A legally authorized representative is an individual who is authorized to make decisions for the patient either by a durable power of attorney (see UIMC HMPP RI 4.02, Addendum 2 Durable Power of Attorney for Health Care Form) or by adjudication (see UIMC HMPP RI 5.01 Healthcare Surrogate and RI 5.02 Guardianship Petitions [for Adult Patients]).
A minor is an individual under age 18 years.
The responsible physician, unless otherwise noted, is the patient’s primary attending physician or resident (a) to whom responsibility for the patient has been delegated, (b) who will assist the attending physician, or (c) who performs the procedure under the supervision of the attending physician.
A substantial risk is one which a reasonable individual in the patient’s position would find important in determining his or her course of action e.g. side effects occurring in greater than 1% of patients treated; loss of life, limb, or special sense organ; or disability.
Voluntary is defined as being freely chose or undertaken of one’s own free will.
The Center for MR Research requires the physician responsible for the patient to:
1. Discuss with the patient (or his or her legally-authorized representative) at a minimum, the possible benefits of the procedure to the individual, substantial risks, possibilities of any material side effects involved in the procedure, medically significant alternative forms of treatment, problems related to recuperation, and probability of success of any proposed procedure.
a. If the patient is competent and does not want discussion with the family, the physician shall honor this request.
b. This process must occur prior to the administration of barbiturates, controlled substances or similar agents.
2. Have the patient (or his or her legally-authorized representative) provide voluntary, informed, signed and witnessed consent prior to the initiation of a procedure. This obligation cannot be delegated to anyone other than the physician. Obtain a new consent for each procedure, unless two separate procedures are done at one time; however, the consent form must detail what procedures are to be done.
3. Write a progress note, including that the discussion occurred and an opinion of the patient’s understanding of the process, diagnosis, and complications per UICMC HMPP IM 4.01 Medical Records: Documentation, Addendum 1 Documentation Requirements, page 4 Point G “Informed Consent (Form and Progress Note).
A separate Center for MR Research policy and procedure governs informed consent for research protocols consistent with UICMC HMPP RI 6.01 Informed Consent for Research Protocols.
Illinois Department of Children and Family Service (DCFS) wards age 18 and over provide their own consent.
The DCFS Guardianship Administrator is responsible for consenting to medical procedures for DCFS wards less than 18 years of age. Consent for procedures may be obtained only from Authorized Agents of the Guardianship Administrator (see UICMC HMPP IM 4.01 Medical Records: Addendum 3 Obtaining Legal Consent for DCFS Wards). Absent an emergency where consent is not required, neither foster parents, caseworkers, nor institutional staff members have authority to legally consent to medical treatment for these wards.
The general consent covers:
a. Emergency procedures which must be performed prior discussion to obtain a specific informed consent;
b. Non-invasive radiological procedures
A specific informed consent discussion must occur and the patient (or his or her legally-authorized representative) must consent in writing before any of the following procedures may take place:
a. Any procedure in which anesthesia, other than topical anesthesia, is used regardless of whether an entry into the body occurs;
b. All treatments which involve substantial risk or harm
The patient’s specific consent is required for each procedure; a consent statement covering two or more procedures is not valid. The patient’s specific consent covers only the procedure discussed with the patient.
HOW COMPLETE THE INFORMED CONSENT DISCUSSION MUST BE:
The responsible physician must provide the patient with the information that a prudent person in the patient’s position would need to know in order to decide whether to undergo a proposed procedure. The test for completeness of this information in Illinois is whether the information provided by the responsible physician is essentially the same information that a physician with the same level of training or experience would provide to a patient in the same or similar circumstances. Risks known by the average patient need not be disclosed. Potential benefit(s) and drawback(s) of the proposed procedure, problems related to recuperation and the likelihood of success shall be explained. Information regarding significant alternative procedure(s) shall be provided.
WHO MUST OBTAIN CONSENT:
The responsible physician who must discuss the procedure with the patient and who shall obtain the patient’s consent in particular treatment categories listed below:
1. Invasive procedures of a diagnostic nature:
a. The physician performing or in charge of the procedure shall be responsible for ensuring the patient has been informed properly regarding the procedure and has consented to them
b. The anesthesiologist involved in the procedure shall be responsible for ensuring that the patient has been informed properly regarding the anesthesia to be used during the procedures and has been consented to them.
2. Non-invasive procedures of a diagnostic nature:
Where a substantial risk of harm exists, the physician supervising the procedure shall be responsible for ensuring that the patient has been informed properly regarding the procedures and has consented to it.
WHEN CONSENT MUST BE OBTAINED:
The responsible physician must obtain the patient’s consent:
1. Not earlier than six (6) weeks before the procedure is performed. If there are any changes in the patient’s medical condition or in the nature of the procedure, the responsible physician must verbally verify the consent and note such discussion in the patient’s medical record.
2. Whenever the patient’s medical condition changes substantially necessitating a change in performance of a procedure or when the course of treatment may be altered significantly for other reasons.
The informed consent discussion and the patient’s specific consent must be obtained prior to the administration of barbiturates, narcotics or similar agents involved in the procedure or psychotropic medications.
If a patient expresses a wish to cancel or revoke the consent, the consent shall be considered invalid at that point in time.
FROM WHOM CONSENT MUST BE OBTAINED:
1. Competent Adult Patient:
Competent adult patients shall give or withhold consent for their own procedures.
2. Incompetent Adult Patient:
If an adult patient is not competent, his or her legally-authorized representative shall grant or withhold consent for any procedure involving that patient that otherwise would have required the patient’s written consent (consistent with HMPP RI 5.02).
If the patient presents in an inebriated condition and his or her alcohol blood level is greater than 0.1GM% (100mg/dl, 1mg/ml), the procedure shall not proceed unless an emergency exists; if his or her alcohol blood level is less than 0.1 GM% (100mg/dl, 1mg/ml), the physician shall exercise clinical judgment and document that the patient understands the information given prior to the initiation of the procedure.
In recognizing the importance of family involvement, where an adult patient is clinically incompetent and a written consent is not required, a physician may be guided by a family member’s consent in providing further professional services consistent with the proper standard of care. It is recommended that informed consent be obtained from the following family members, in the order listed-
b. Adult child;
c. Parent; then
d. Adult brother or sister.
If an adult patient is incompetent and his or her legally authorized representative is not physically present, the legally authorized representative may consent to the procedure by telephone or by sending a telegram indicating consent. To be valid, telephone consent must be verified by at least two witnesses.
3. Minor Patient
a. If a patient is a minor, his or her legally authorized representative shall grant or withhold consent for any procedure involving that patient unless the patient is emancipated or unless federal or state law provides otherwise. Unless the situation indicates otherwise, as in the case with DCFS wards, the parent or parents of a minor child are implicitly considered the child’s legally authorized representative(s) and may consent or withhold consent for that minor child’s procedure.
If the patient is a minor and his or her legally authorized representative is not physically present, the legally authorized representative may consent to the procedure by telephone or by sending a telegram indicating consent. To be valid, telephone consent must be verified by at least two witnesses.
b. A minor who is married, who is legally emancipated or who is pregnant may consent or withhold consent for any procedure.
c. A minor who is a parent may grant consent for procedures for his or her child.
MUST CONSENT BE OBTAINED IN MEDICAL EMERGENCIES
If an emergency exists and it is not reasonably feasible to obtain consent without adversely affecting the patient’s condition, the healthcare professional shall render appropriate emergency treatment without the patient’s informed consent.
The responsible physician shall document in the medical record the clinical nature of the emergency and what reasonable attempts were made to contact the patient’s legally authorized representative to obtain consent.
MUST INFORMED CONSENT FORMS BE USED
If the clinical department has developed a consent form for a particular procedure it shall be used to document that the informed consent discussion occurred and that the patient voluntarily consented. If no consent form has been developed, the responsible physician shall:
1. Note in the medical record the content of the informed consent discussion and that the patient voluntarily consented; and
2. Use the standard form filling in the particular procedure and have the patient sign.
After the informed consent form discussion has occurred and after determining that the patient understands and voluntarily consents, the responsible physician shall fill out, sign, have the patient sign a consent form, and have the execution of the form witnessed. Any competent adult, including hospital personnel (except the attending physician) may witness the patient executing the consent form. By signing as a “witness”, the individual represents observing the patient sign the consent form voluntarily.
A copy of the consent form shall be included in the patient’s medical record.
If the informed consent discussion has occurred and the patient determines not to consent to the procedure, the consent form shall be placed in the patient’s medical record with the notation “Patient refused to sign this document.”
Sponsor: Director Date: 8/01
Policy 7: Conscious Sedation for Procedures
Physicians who are privileged to perform clinical procedures for which conscious sedation is routinely used will be privileged to order and supervise the administration of intravenous conscious sedation as part of the privileging for the procedure.
Physician privileged to perform intravenous conscious sedation:
1. Consider as candidates for the procedure only those patients whose physical status permits pulmonary and cardiovascular stability.
2. Arrange for the assistance of a qualified individual to intermittently assess the patient’s ventilatory and vital signs parameters. Ensure the immediate availability of a resuscitation cart, which includes equipment for airway maintenance, temporary ventilatory support, and emergency medication.
3. Maintain NPO status, dependent upon the sedative used.
4. At the end of the procedure, determine when to discontinue assessing the patient and release them to home or floor care.
5. Ensure that outpatients have a responsible adult to take them home and take care of them.
6. In the patient’s medical record, document all monitoring results and observations, including when the patient no longer requires monitoring.
7. If a patient who has received intravenous conscious sedation must be transferred prior to release:
a. Ensure the continuation of not less than pulse oximetry during the transfer; and
b. Transfer only to another setting which can provide the continuing monitoring.
8. Report mortality and significant morbidity related to conscious sedation at the time of each occurrence consistent with HMPP EC 3.01 Patient Occurrence Reporting.
9. Report adverse reactions related to the use of conscious sedation through an Adverse Drug Reaction Report form (HMPP TX 2.04) or Patient Occurrence Report (HMPP EC 3.01)
Policy 8: Release of Confidential Information
It is the policy of the Center for MR Research that confidentiality of all records is maintained I regard to the release of patient/subject, in compliance with the Medical Information Act of 1981 and the University of Illinois at Chicago Medical Center policies.
1. Department personnel will release only confidential information maintained exclusively by the Center for MR Research. This information includes MR files, assessments and consults.
2. All outside requests for copies of films must be in a written form. An appropriately executed Release of Medical Information form must accompany the written request. The written request and Release of Medical Information Form must be forwarded to the UICMC Radiology Film Library for response.
3. The patient or subject authorizing the release of medical information must have the legal authority consistent with UICMC policy to authorize the release of the information.
4. It is the policy of the Center for MR Research to release patient information gathered for research purposes consistent with the guidelines established by the Informed Consent Form approved by the IRB for the specified clinical research protocol only.
Policy 9: Clinical Study Billing Procedures
Non-research clinical scanner time will be billed by the UICMC through the normal billing process using PACS, ADAC, and Patient Management System.
1. The Clinical Study will be ordered on the standard UICMC Request For Magnetic Resonance Exam form.
2. On arrival the MRI center reception personnel will register the patient as they would any patient for an MRI.
3. This registration process generates a PPF form which will result in a report being dictated and the UICMC will bill for the study through normal billing process.
Policy 10: Billing Procedure for Medications/Drugs Utilized for Non-research
All medications and drugs utilized in the studies performed on the 3T scanner must be paid for by billing to the patient. Note: Contrast media is considered as part of the global fee charged for clinical MRI studies and is not billed separately unless directed to do so by the Director, Center for MR Research.
1. An accounting of all medications/drugs will be maintained by the Clinical Research Coordinator (See Safety section Policy 9).
2. Drugs/Medications will only be prepared at the time they are to be administered. All medications and doses will be recorded on documentation of the study.
3. For Outpatient non-research studies, the Clinical Research Coordinator will prepare a prescription form indicating the name of medication, dosage, means of administration, date, patient’s name, and UIC Medical Record number. This will be signed by the Director of the Center for MR Research with his DEA number indicated. The Clinical Research Coordinator will also indicate the drug is to be replaced to Center for MR Research stock. The completed prescription will be sent to the Outpatient Pharmacy (Attention: John Gargas) for billing to the appropriate payer.
4. For Inpatient non-research studies, a Physician’s Order will be prepared for the chart including all the information indicated on the Outpatient Prescription. It will be signed by the Director for the Center for MR Research at the time of the study. This will be billed by the Inpatient Billing area with other Inpatient Charges. Note: It must indicate a return to stock supply is needed for Center for MR Research.
Policy 11: Diamox Injection
All outpatient and inpatient requests for 3T fMR studies that include perfusion with diamox injection will be administered by a staff radiologist or OCC MRI nurse. All diamox will be acquired through the pharmacy. The ordering MD must fax an order for diamox to the CMRR to be filled prior to the patient’s exam.
· Any patient with an allergy history to Sulfa drugs or has previous history of glaucoma CANNOT receive diamox.
All patients to receive diamox must have a 20G antecubital IV.
1. Upon completion of the initial perfusion sequence, the MR technologist will set out two (2) 500mg vials of diamox (aka: Acetazolamide) and three (3) 10ml vials of sterile water.
2. The MR technologist will unhook the injection tubing and flush the patient IV with 10 ml of STERILE WATER ONLY. The MR technologist will attain and record the patient’s baseline blood pressure.
3. The radiologist or OCC MRI nurse will then reconstitute the diamox injection using STERILE WATER according to the guidelines for diamox administration.
4. The radiologist or OCC MRI nurse will administer 10ml of diamox to the patient via IV access at a rate of 2ml / min. and the patient’s BP will be monitored at 1 minute intervals.
5. Once the diamox injection is completed, the radiologist or OCC MRI nurse will flush the patient IV with 10 ml of STERILE WATER.
6. The post diamox perfusion scan will be performed 15 minutes after the administration of the initial 2ml of diamox.
7. The IV will remain in place until the patient is off the table, out of the scan room, and cleared by the radiologist or OCC MRI nurse for any possible adverse side affects.
8. In the event that the patient would be deemed symptomatic, 250ml of normal 0.9% Sodium Chloride Saline will be administered via the patient IV access and the patient’s blood pressure will be monitored.
9. The patient’s release will be conditional upon the reassessment by the radiologist or OCC MRI nurse.
Policy 12: Clinical fMR cases
All outpatient and inpatient requests for 3T pre-surgical fMR studies that CANNOT be placed onto the schedule due to time slot availability should be brought to the attention of Mike Flannery and/or Dr. Thulborn for further review.
1. The ordering physician and/or office staff that is requesting the pre-surgical fMR study will be told that the CMRR will make arrangements to accommodate the patient study.
2. Hagai will need to bring the patient order and screening form to Mike and inform him about the schedule conflict(s).
3. Mike will then evaluate the possibility of opening up a research time slot to accommodate the physician request for fMR services. Any research slot may be utilized for clinical services as long as the slot is not scheduled with funded research. All development and pilot accounts may be subject to being “bumped” off the schedule in order to free up time on the schedule per Dr. Thulborn.
4. If time can not be made available during the research hours, Mike will present the case to Dr. Thulborn for further review.
5. Dr. Thulborn will then make the necessary arrangements with clinical services to make the necessary time available on the outpatient 3T schedule.
Date: Rev 1, 10/06
Policy 13: 9.4T helium fill
The building manager will be notified of all helium fills at least 24 hours in advance to ensure proper coordination of building services.
1. Notify the building manager (Fred Piemonte, 996-4546) at least 24 hours before the fill is scheduled to occur.
2. Notify the building manager immediately after the fill is completed.
Policy 14: Laundry and Linens
Any user placing laundry into a hamper that is at least 50% full is responsible for immediately emptying the hamper. Any user taking the last of any linen (including blankets, towels, sheets, gowns, etc) is responsible for immediately restocking the linen cabinet.
Policy 1: Safety Precautions
It is the policy of the Center for MR Research to provide the following safety procedures for the subject and staff members.
A. Patient Safety
1. Transportation of UICMC Patients between UICMC Buildings will be done in compliance with CC 6.02 and CC 6.03 of hospital policy.
2. Every effort will be made to observe the patients/subjects at all times while in the imaging room or hallway.
3. Side rails or restraining devices must be used for patients transported by stretcher.
4. Patients shall be properly immobilized while on the examination table.
5. Proper assistance must be given when transferring the patient from the stretcher or wheelchair for an imaging exam.
B. Fire & Explosion
1. In the event of fire, the fire alarm must always be activated and proper personnel shall be notified. All patients/subjects must be placed in a safe area, not left in the hallways.
2. In the event of fire in an examination room, immediately turn off the main power switch.
3. Always follow hospital fire instructions. Center for MR Research will always be in compliance with Hospital policy EC 1.01 and EC 1.02 and Radiology department policy 01-01-0011.
C. Personnel Radiation Safety
1. When a staff member notices a defect in the equipment it should be reported immediately to the supervisor.
2. If sparking or burning odor is noted the equipment should be turned off, the circuit breaker should also be turned off. It should be reported to the supervisor.
3. If equipment that slides or rolls seems difficult to move or unstable, it should be reported to the supervisor.
4. Equipment with sharp edges, missing guards or bent guides should be reported to the supervisor.
Policy 2: Patient/Subject/Visitor/ And other members of the Healthcare Team Safety (MR)
It is the policy of the Center for MR Research to provide guidelines for patient/subject and members of the healthcare team and visitors safety while in the MR environment.
A. Patient/Subject Safety
1. Screening must be completed on all patients/subjects prior to entering the magnet room. The assessment form must be completed and signed. Orbital CT will be required on all subjects who have a history of metal in the eye.
2. Patient/Subject will be observed at all times while in the magnet.
3. Patient/Subject shall be properly immobilized while on the MR table.
4. Proper assistance must be given when transferring the patient from the stretcher or wheelchair for an MR exam.
5. If there is a reason to believe a patient/subject may be pregnant, she will not be examined before her physician is notified and/or a radiologist consulted and the examination is determined essential to the patient’s care.
6. Patient/subject should be notified to advise staff of warm or strange sensations while in the magnet.
7. Patients with aneurysm clips will not be placed in the Center for MR Research scanner until we are in posession of documentaition stating that the aneurysm clip has been tested safe for 3T. The document must include the following information:
a) manufacturer of the clip,
b) make and model,
c) where the surgery was done.
8. Any subject having magnetic resonance sequences must have hearing protective devices IN PLACE before proceeding with scan.
9. Staff is required to check under EKG patches and gating devices at patient contact locations at regular intervals throughout the exam on patients sedated or unable to communicate a problem.
10. Patient exposed regions should not be allowed to come into contact with the bore of the magnet (housing) itself.
11. All unnecessary/extraneous electrical conductors should be removed from the bore during imaging.
12. Care should be taken to ensure that no unnecessary loops are made by any electrical conductor in the imaging system. These include such entities as EKG, gating wires, surface coil leads, etc.
13. The Patient’s/Subject’s skin should not be involved in any electrical conductive loop. EKG lead should be braided around each other to decrease the possibility of forming a large radius loop. However, EKG, surface coil and pulse oximeter cables should not be braided together as this may interfere with monitoring capabilities. These wires should also be kept as far as possible from the walls of the magnet bore.
14. Thermal insulators (including space/air) should be used between any electrical conductor device and the patient to ensure that the potential for burns from the thermal conductivity from electrical conductors in the imaging system with the patient would be minimized.
B. Family/Ancillary Staff Safety
1. Screening must be complete on all visitors prior to him/her entering the magnet room. Should a visitor require medical attention (e.g. x-rays; CT) to comply with our medical screening, then the radiologist must request the testing.
C. Patient Medical Emergency
1. All medical emergencies involving patients in the magnet room should observe the following procedures:
a. Check patient status. If the patient is in cardio insufficiency then:
b. Press Stop Scan button on console immediately.
c. Open Scan door. Notify emergency personnel (Call 171. Say “Number One Emergency in MRI Center Room 1A first floor, South tower, 1801 W. Taylor (OCC).” specify adult or pediatric depending on age of patient. Provide your name, telephone number, and patient name, if known.)
d. Evacuate patient by depressing the blue emergency release button located at the foot of table. Push table slightly forward and pull cradle out of magnet until fully retracted. Unlock table by pushing yellow emergency release button found on either side of patient table.
e. If surface or head coil is in use, disconnect prior to removing table from position.
f. Transfer patient to designated emergency area (Patient prep area immediately outside of Scanner Room).
Policy 3: Emergency Crash Cart and Emergency Drug Box
The Center for MR Research has been provided access to emergency drug boxes and emergency crash cart for management of acute medical emergencies. The emergency crash cart is to be used for Number 1 Emergencies only (Cardiopulmonary arrests). The emergency equipment is available for adult and pediatric emergencies. (Addendum A – Emergency Equipment location)
The pharmacy is responsible for maintenance and upkeep of these emergency crash carts and emergency drug boxes. Contents are specified on the inventory-charging sheet and each emergency drug box must have a listing of drug content. In addition each emergency crash cart and emergency box must have a content expiration date sheet attached. (Addendum B – Expiration Date Sheet).
A. Emergency Crash Cart
1. All emergency crash carts are to be checked by a pharmacist prior to delivery to the floor. Each emergency crash cart should have an expiration date sheet attached on the outside with the expiration date signed by the pharmacist who checked the contents. All carts should be locked using a non-reusable device. All inpatient carts will be locked using a serial number device with the corresponding number documented on the expiration sheet.
2. Expiration dates on emergency crash carts and emergency drug boxes in the area will be reviewed each month and documented on the monthly check form by the assigned Clinical Research Coordinator or Magnetic Resonance Technologist.
3. The Clinical Research Coordinator or Magnetic Resonance Technologist will check the equipment on the crash cart daily for readiness. The daily check will be recorded on the appropriate tracking sheet.
4. Immediately following a Number One Emergency the emergency crash cart must be replaced. The satellite pharmacist/ER resident attending the arrest will be responsible for the following:
a. the emergency crash cart must be exchanged as the Center for MR Research must never be left without an emergency crash cart.
b. the charge included with the emergency crash cart must be stamped with the patient’s name and account number.
5. After the use of the emergency drug box the assigned Center staff will deliver the drug box to the pharmacy for restocking. A requisition and voucher will be generated for the replacement item charges.
Policy 4: Guidelines For Handling Sharps
It is the policy of the Center for MR Research to provide guidelines for the handling of sharps, reusable sharps, and the safe and proper disposal of contaminated and other sharp material. This is consistent with the UIC Policy.
Sharps are generally disposable items, which are used to puncture or cut through the skin for medical/surgical procedures. All sharp items when handled improperly may cause not only a laceration but also infection.
A. Disposable sharp items include but are not limited to:
1.) Disposable plastic syringes with needles.
2.) Disposable glass syringes with needles.
3.) IV administration sets (intercath, butterfly needles, etc.)
4.) Blood collecting needles.
5.) Lancets, pinprick, suture needles.
6.) Disposable cutting blade (razors/scalpels)
7.) Glass ampoules, broken glass
8.) Disposable metal pharmaceutical seals, i.e. as on IV bottles
I. Storage of Sharps
A. Unused syringes and needles are kept in a location in order to prevent unauthorized use.
II. Handling of Sharps
A. Wash your hands prior to handling sharps. This decreases the chances of infection. Wear gloves to protect you from surface contamination, when appropriate.
B. Avoid touching the sharpened edge/point.
C. Keep the protective covering in place (while transporting the sharps) until the sharp item is needed.
D. Never carry sharps in a pocket without a plastic cap in place.
E. Discard all the disposable sharps according to instructions below.
F. Remove all full contaminated boxes as outlined below.
III. Guidelines for disposing of disposable sharps
A. To discard disposable needles/syringes or any other potential sharps that have been used in normal situations or isolation cases.
1. After injection do not recap the needle.
2. Take the used sharp to the nearest sharp disposal box
3. Place entire needle and syringe in container
4. Take care not to overfill the box
5. Never place used sharps in the regular trash.
B. Procedure for disposable needles/syringes ampoules contaminated with radioactive materials.
1. After injection recap the needle, except butterflies. Safe needle recapping is required.
2. Place entire item in the red cover sharps box provided for that purpose.
3. Never place used sharps in the regular trash.
IV. Procedure for removing full contaminated boxes
A. Needle boxes or Sharps containers.
1. Close opening and secure.
2. Contact housekeeping for pick up of the full box. The full box should be picked up by housekeeping services
3. Place the new empty box in service immediately.
B. If the disposable needle box contains radioactive material
1. Close the lid, label and date.
2. Place the entire box in the area for holding radioactive decay storage.
3. When the material is safe radiation safety will supervise the incineration.
V. Guidelines to follow when a cut or puncture wound occurs when handling sharps:
A. Press a few drops of blood to minimize contamination.
B. Wash site for 10 minutes with antibacterial soap and running water.
C. Apply cold water to area to stop bleeding.
D. Try to determine if the item involved was clean or contaminated. IF the case is unknown, consider it contaminated. Try to determine if used on a particular patient. If used on an outpatient, request that the patient wait for potential blood work.
E. Immediately inform the supervisor and secure a medical evaluation per HMPP HR 1.01 (At all times to Emergency Services Department (ESD) for severe injuries and for serious work related injuries. During normal business hours to University Health Services (UHS). During non-business hours and on weekends and holidays ESD. An employee initially seen in ESD must report to UHS on the next business day.)
SEE ALSO HMPP IC 3.01A for Management of Employee Exposure to Blood and Body Fluids.
Policy 5: Infection Control/Universal Precautions
It is the policy of the Center for MR Research to protect both the subject and the department staff by minimizing the exposure to communicable disease. Further, it is the policy of the Center for MR Research to provide a safe environment for patients, subjects, employees, students, and volunteers through minimizing the risk of transmission of infectious diseases that are blood/body fluid borne. To facilitate these policy objectives, universal precautions will be maintained as described in UIC Policy.
Definition (universal precautions)
Universal precautions define any patient as potentially infectious and recommend the use of barrier protection and equipment where appropriate.
A. University of Illinois at Chicago Hospital
In addition to the use of Universal Precautions for all subjects, the UICH utilizes additional Isolation/Precautions described below.
1. Strict – to prevent transmission of all highly communicable diseases that are spread by both contact and airborne routes of transmission.
2. Respiratory – to prevent transmission of organisms by means of droplets and droplet nuclei that are coughed, sneezed or breathed into the environment.
1. Direct Contact – to prevent transmission of epidemiologically significant microorganisms by personnel having direct contact with patient/subject body sites colonized or infected with such organisms.
2. Chicken pox/Shingles – to prevent employees susceptible to chicken pox from acquiring infection from patients/subjects with chickenpox/shingles.
I. Strict Isolation – highly communicable disease transmitted by both the respiratory route and by direct contact.
A. The imaging and waiting room to receive a strict isolation patient should have all unnecessary ancillary equipment removed.
B. The strict isolation patient will be taken directly into the designated exam room and will not be left in the halls or waiting area.
C. The patient should be wearing a gown and a mask.
D. Only a limited number necessary imaging staff will be in the room during the procedure.
1. Gowns – individual gown technique is imperative for all persons entering the room.
2. All persons entering the room must wear masks.
3. Hands must be washed with Betadine for at least 30 seconds before and after contact with he patient.
4. All persons entering the room must wear gloves.
5. All disposable dressings, or other contaminated disposable items should be put into red hazardous waste bags prior to leaving the room. Linen should be put into the red plastic bags and handled as contaminate/biohazardous.
6. All needles and sharps should be placed in impervious plastic needle boxes available in each room. Needles should never be recapped. See Safety Policy 4.
7. Special procedure trays and special instruments should be separated into: a) disposable, b) autoclavable, c) linen, etc. The instruments and trays should be seen to Central Service for decontamination/sterilization. Routine inspection of holding areas for outdated trays and supplies is mandatory. Linen should be placed in blue linen bags and handled as contaminated.
8. During or immediately following the procedure, the Housekeeping Department should be notified that the exam room and equipment must be cleaned.
9. No personnel should enter the exam room until it has been cleaned.
II. Respiratory Isolation – infectious droplets that are coughed, sneezed or breathed into the environment. Childhood diseases including mumps, rubella (German measles), and measles are put into this category.
ATTENTION: Pregnant staff members should not perform examinations of rubella patients
A. Imaging room should be ready to receive the patient as soon as possible upon his/her arrival.
B. Patient should be wearing a mask during transport and the procedure, if possible.
1. Gowns are not necessary, unless dictated by Universal Precautions needs.
2. Masks are necessary while in close proximity with the patient. (This includes all persons entering the exam room.)
3. Hands must be washed with Betadine for at least 30 seconds.
4. Gloves are not necessary, unless dictated by Universal Precautions needs.
5. Needles and syringes – needle box – disposed by Housekeeping.
6. Dressings and tissues should be put in red hazardous waste bags to be incinerated without being opened.
7. Linen – blue plastic bags.
8. The patient’s chart may be taken into the room
9. Normal housekeeping procedures.
III. Cleaning Procedures in Patient Care Areas
The pulse oximeter and sensor, dynamap, etc. should be cleaned after every patient use with a low level disinfectant. Visible contamination with blood should be cleaned with 10% Clorox solution.
Instrumentation is cleaned after each patient use with alcohol or bleach solution. Patient restraints are soaked in a Clorox solution for disinfection.
Any employee who experiences a needle stick or cut with a sharp instrument or a splash of blood or body fluids into a mucous membrane (eye, nose, mouth) should report to their supervisor and University Health Services. See Safety Policy 4.
Outdated materials and items must be discarded appropriately.
Please see Hospital Policy IC 1.02, 1.03, 2.01, 2.02, 2.03, 2.04, 2.05, 3.01A, 3.01B, 3.02, and 4.00 for more detailed information regarding any of the above items. The Center for MR Research will always comply with UICMC Hospital policies on infection control.
Policy 6: Equipment Safety
It is the policy of the Center for MR Research to provide guidelines for maintaining equipment safety. There is an equipment management program designed to assess and control the clinical and physical risks of fixed and portable equipment used for the diagnosis, treatment and care of patients. Written criteria will include the characteristics of equipment function, clinical application, maintenance requirements and equipment incident history.
All patient care monitoring equipment shall be inspected and tested by CES (Clinical Engineering Services) prior to use when new, after any repairs are made, and at intervals not to exceed 6 months thereafter. In compliance with University of Illinois at Chicago Radiology Policy 05-02-0005
Before a new piece of equipment is used, the medical physicist in Radiology evaluates it, and the evaluation is documented. In compliance with University of Illinois at Chicago Radiology Policy 05-02-0005
Equipment such as leads, EKG, pulse oximeter, surface coils, should be checked by Center for MR Research staff prior to each patient application.
Staff shall report any defective equipment.
Equipment with sharp edges or missing guards should be reported to the supervisor.
< If the oxygen alarm sounds, immediately open the scan room door. Stop scan by pressing the Stop Scan button on the MR console. Evacuate the area. In the event that the scan room door should ever jam, access to the scan room can be achieved through the view window.
Notify equipment service engineer to remove any metal object(s) that may be in the field or stuck to the side of the magnet. Trying to remove the objects yourself could result in a serious personal injury or spontaneous quench of the magnet.
Policy 7: Electronics Laboratory safety and inventory control
It is the policy of the Center for MR Research to provide guidelines for the safe use and inventory control of the equipment and supplies in the electronics laboratory.
I. Equipment and Supplies
A. Anyone borrowing tools from the electronics lab or machine shop must record his/her name, the date and the item borrowed on the Instrument/Tool Sign-Out Form located in the Electronics Laboratory. (See attachment)
B. Tools or instruments must be returned on the same day in order to best assure availability of the limited resources. If the item is needed for a longer time, approval from the Engineer for the Center for MR Research is required.
C. All tools must be returned to the original storage site after use.
D. Anyone using any components or parts from the lab must complete the Parts Order Form (See attachment) to replace the used components or parts. If the items are already in short supply (only one or two remaining), they are not to be used without first obtaining approval of the Engineer for the Center for MR Research or the Center Director.
E. All cabinets and drawers should be labeled to identify contents. If you use any unlabeled shelves or drawers, action should be initiated to label the storage area. Coordinate labeling with the Engineer for the Center for MR Research.
F. The door to the Electronics Laboratory must be locked upon completion of your work.
A. All users must be sure to turn off the power and/or unplug any instruments, power tools and soldering irons after use.
B. Safety glasses or other appropriate eye protection must be worn whenever required in the Electronics Laboratory.
C. Users must clean the area after finishing work, paying special attention to the counters and other work surfaces. Housekeeping is not responsible for cleaning these areas so all must assume responsibility for maintaining a clean shop.
D. Only qualified users may use the electronics laboratory instruments and tools. The Engineer for the Center for MR Research or an appointee shall provide appropriate instruction to any unqualified person prior to their use of the laboratory equipment
Policy 8: POWER FAILURE – EMERGENCY
To continue essential services during a power failure, Center staff should be aware of and observe emergency procedures applicable to power failure.
Electrical service maintained by emergency power:
1. Minimal hallway lighting
2. Emergency hallway lighting (red lights)
3. ID Activated doors
5. Selected wall receptacles (red plates)
ACTIONS TO BE TAKEN
A. Identify immediate priorities – patient/subject and staff safety
B. Organize available resources to meet immediate priorities
C. Determine extent of power failure
1) local failures such as circuit breakers affecting an outlet, room or a small section
2) major failure affecting entire building or portions of the campus
D. If emergency power is available, plug life sustaining equipment into receptacle on emergency power system (red plates)
FOR LOCAL POWER FAILURE
A. Notify electrician at extension 6-7511 when failure occurs during the day shift
B. For 24 hour call extension 6-7180 – routing heat, light, or power
FOR MAJOR POWER FAILURE
A. Notify electrician at extension 6-7511 when failure occurs during the day shift.
B. For 24 hour call extension 6-7180 – routing heat, light, or power
Notify Director or designate on call/duty
C. Reassure patients/subjects that they are in no immediate danger.
Policy 9: Cardiopulmonary Resuscitation
The Center for MR Research recognizes that the patient, staff, or visitor who experiences the sudden, unexpected cessation of cardiopulmonary functions, is best managed by an interdisciplinary team trained and equipped to implement cardiopulmonary resusitation (CPR). All Center for MR Research staff will be certified in Basic Life Support (BLS – Adult/Pediatric); Advanced Cardiac Life Support (ACLS); Pediatric Advanced Life Support (PALS) and will maintain current certification throughout their employment with the Center. Documentation of current certification must be maintained in each staff member’s human resource file.
Center for MR Research staff will honor patients’ written, dated, and signed advance directives and living wills as well as do-not-resuscitate orders (see HMPPs RI 4.02 Advance Directives; RI 4.03 Do not Resuscitate for adult patients; and RI 4.04 Do not Resuscitate for pediatric patients).
Any Center for MR Research staff who initiates CPR must be trained as a basic life support provider.
The CPR team shall consist of 1) a medical physician-resident certified in Advanced Cardiac Life Support (ACLS), 2) an anesthesiology physician-resident, 3) nurses who staff the Center for MR Research, 4) nurse from the Critical Care/Emergency Services Division (ESD), 5) pharmacist, 6) respiratory therapist, and 7) transporter assigned by Transport Dispatch Center. The Code Team Leader is the senior medical physician.
The nurse must complete a CPR documentation form for every CPR. The Code Team leader must sign the completed CPR documentation form.
The UICMC CPR Team will be activated by dialing 171.
I. Summoning the UICMC CPR Team
Policy 10: Adverse Drug Reaction – Clinical Studies
To recognize our responsibility for reporting adverse drug reactions as a means for improvement of patient care and outcomes.
For the purpose of this policy, the following definitions apply:
An adverse drug reaction (ADR) is “any response to a drug that is noxious and unintended and that occurs in doses used in man for prophylaxis, diagnosis or therapy, excluding failure to accomplish the intended purpose” (source: World Health Organization Technical Report, 1969, No. 425). Any reaction requiring a major change in the patients’ management, e.g., hospitalization, prolonged length of hospital stay, or alterations in drug therapy, must be reported. Reactions may include:
1. Those resulting from an exaggerated, but otherwise usual or expected, pharmacological action of the drug, e.g., hypokalemia-induced dysrhythmias secondary to diuretic therapy administration;
2. Reactions resulting from an unexpected, aberrant response to the pharmacological action of a drug when given in therapeutic doses, e.g., malignant hyperthermia from anesthesia and many immunologically-mediated reactions; and
3. Severe reactions resulting from deviations from the established drug therapy regimen, e.g., asystole secondary to rapid intravenous administration of phenytoin and acute renal failure due to elevated vancomycin serum concentrations.
In compliance with the recommendations of the Joint Commission on Accreditation of Healthcare Organizations, the Center for MR Research maintains a formalized Adverse Drug Reaction Reporting Program consistent with the University of Illinois at Chicago Medical Center policy. This program also reflects the guidelines of the Food and Drug Administration (FDA) for reporting and documenting unusual, serious, or life threatening reactions to drugs.
The UICMC Pharmacy Quality Assurance Area shall coordinate the Adverse Drug Reaction Reporting Program under the auspices of the UICMC Pharmacy and Therapeutics Committee.
All health care professionals must report and document any incident in which an adverse drug reaction is suspected.
A. Any Health Professional Suspecting an ADR must notify a physician-resident and/or attending physician.
B. Physician will assess the nature of the ADR and manage the patient accordingly.
C. Physician, Pharmacist, Nurse or MR Technologist administering medication will –
1. Document the ADR in the patient’s medical record.
2. Complete Adverse Drug Reaction Report Form (see Addendum) and forward it to any pharmacy area. If assistance is needed to complete the form, help is available from a pharmacist. NOTE: Copies of Adverse Drug Reaction Report Form are available in central pharmacy, all satellite pharmacies, and the Pharmacy Quality the department. The ADR form is also located in the Outlook Public Folders under Pharmacy/ Forms.
3. Provide information for follow-up (patient outcome), if requested.
D. Pharmacy Department will
1. Assist in completing Adverse Drug Reaction Report Form if contacted with report of a suspected ADR, or upon detection of an ADR.
2. Review Adverse Drug Reaction Report Form and judge need to contact pharmaceutical manufacturer and/or FDA.
3. Inform Risk Management when appropriate (see MCMPP EC 3.01 Patient Occurrence/ Sentinel Event Reporting).
4. If the drug involved in the report is an investigational agent, contact the principal investigator. If necessary, aid in the completion of any forms for the Institutional Review Board and study sponsor.
5. Conduct quarterly reviews of ADRs to determine any significant trends.
6. Provide quarterly summary of all reported ADRs to Pharmacy and Therapeutics Committee.
7. Provide quarterly summary of all reported ADRs to the Quality Management Department for distribution to the medical staff’s departmental quality assurance programs.
E. UICMCPharmacy and Therapeutics Committee will
1. Initiate changes in drug use policies and procedures when appropriate.
2. Monitor the adverse drug reaction program.
Adverse Drug Reaction Report Form
University of Illinois at Chicago Medical Center,
Medical Center Management Policy and Procedure Manual,
EC 3.01 Patient Occurrence/ Sentinel Event Reporting
World Health Organization Technical Report, 1969, No. 425
Policy 11: Quality Assurance Procedures
Policy Quality Assurance is performed daily at 8AM on the Synchronization Control System.
1. Turn on all equipment and check to see if functioning properly:
A. Boot up SCS: PC Workstation, LCD Monitor, and SCS control box.
B. Turn on Pulse oximetry.
C. Turn on eye camera and LCD viewer.
D. Install and check LED illumination on coil.
E. Turn on projector: Apply power and press POWER button to operate projector lamp.
F. Start the labview program: Synchronization Control System.
2. Perform projector QA and image alignment:
A. Check visor transparency – Install the transparency if it has been removed. The transparency on the visor must be checked to make sure that it is in the proper position. The position of the fixation cross on the transparency should be 10.6 cm from the left screen inside edge and 4.5 cm from the top screen inside edge.
B. Check the projector trolley wheels for dust – this can offset vertical alignment.
C. Check that cables do not interfere with projector movement.
D. Confirm that the Head Coil base is correctly seated and clamped on the patient table. This affects the visor screen alignment.
E. Line up the projected cross with the cross on the visor. The file “QA paradigm.avi” is projected and is used to align the projected fixation cross with the cross on the visor.
3. Run the QA paradigm to check the projected image:
A. The width of the projected image should be 7 inches when land marked according to the QA marker located on the visor.
B. Check for dust in the lens. Look for color specks in a dark background.
C. Check for any delays within the paradigm or any flashing of the projected image.
D. Time the paradigm with a stopwatch to make sure it runs for the correct amount of time.
4. The SCS system is used to record the following data to a file. File is then checked.
C. SpO2 level
D. Trigger signal from GEMS 3T
E. Finger switches
Policy 12: Patient Safety and Screening for 3T examinations
All outpatient and inpatient requests for 3T MRI studies must have proper screening documentation. It is the responsibility of the technologist performing the exam to read all attached patient documentation prior to placing any patient into the 3T scan room.
* Any patient with a known and well documented medical device that is NOT deemed SAFE at 3T will not be scanned at 3T.
* A 1.5T exam may be performed at the discretion of the ordering MD and ONLY if the medical device is deemed SAFE at 1.5T.
1. All outpatient 3T requests MUST have the “3T Patient Pre-Screen” section filled out in its entirety.
2. The person scheduling any outpatient will be responsible for obtaining the responses from the patient or guardian for the “3T Patient Pre-Screen” section prior to scheduling an appointment. (This is mandatory EVEN IF THE ORDERING MD HAS FILLED OUT THIS SECTION)
3. All aneurysm clips, heart valves, and other well known MRI medical device safety hazards will require proper identification and documentation prior to scheduling or entering the 3T scan room.
4. All questionable medical devices will require full documentation of the Make, Model, and date the device was implanted without exception.
5. The technologist is to bring the patient screening form to either Dr. Thulborn or Mike Flannery to check for potential risks prior to taking any patient in the 3T room.
6. It will be the responsibility of the scanning technologist to evaluate continued patient safety throughout the exam.
7. All unknown artifacts seen on an image(s) should be immediately questioned and the scanning technologist should seek expert advice from a radiologist and/or another qualified technologist before proceeding with the exam.
1. All inpatient 3T requests will require a 3T patient safety screening form to be completed before sending for the patient.
2. The screening form will be sent to the appropriate floor via the tube system to be filled out by the patient, guardian, and/or nurse.
3. Proceed by following the same procedure for outpatient exams (3-8 above).
Date: Rev 2, 10/06
Policy 1: Research Accounts
It is the policy of the Center for MR Research to manage the resources of the Center by requiring each investigator to set up a Research Account for each of their protocols.
The forms and directions for setting up a Research Account may be found at the website for the Center for MR Research www.uic.edu/com/mrc.
1. Submit the following documentation with an MR Budget Preparation Worksheet to the Grant Administrator –
A. Title of Project
B. Name of the Principal and all Key Investigators
C. Specific Aims with the testable hypothesis
D. Background (brief but concise)
E. Preliminary Data (already available, both behavioral and imaging)
F. Methods: Data analysis and statistics, to include number and duration of MRI examinations with justification. Inclusion and Exclusion criteria must be given
G. IRB protocol and approval number (state if it has been submitted but pending approval).
H. Funding agency and the indirect cost rate. If indirect cost is less than the NIH rate, then documentation of the agency indirect rate is required.
I. Do NOT include a Bibliography.
2. After the Grant Administrator assigns an account number, provide the Clinical Research Coordinator with the IRB approved copy of the Informed Consent Form. This must be done before any subjects will be scheduled unless otherwise authorized by the Director of the Center for MR Research.
3. See General Policy 1 of this manual for scheduling subject
Policy 2: Informed Consent for Research Protocols
Before the initiation of any human subject research at the Center for MR Research, the Institutional Review Board (IRB) of the University of Illinois at Chicago must approve the protocol, the informed consent document, and any written solicitation for subjects. No human subject research shall occur at the Center of MR Research without the approval of the IRB and with the research subject’s voluntary written consent, except as noted below.
A principal investigator may address questions regarding research protocols and informed consent requirements to the chair of the IRB or to the University’s Office for Protection from Research Risks in the Office of the Vice Chancellor for Research.
The Center for MR Research will perform consistent with UICMC policy and procedures governing the use and control of investigational drugs (see HMPP TX 2.06 Use and Control of Investigational Drugs).
For the purpose of this policy, the following definitions apply:
Research is a systematic investigation designed to develop or contribute to generalizable knowledge or the acquisition of data, which may in the future be used to develop generalizable knowledge.
Protocol is any plan of an experimental nature, including plans relating to investigational drugs and investigational medical devices.
Principal Investigator (PI) is a person responsible for the conduct of the research or clinical trial at a trial site. If a trial is conducted by a team of individuals at a site, the investigator is the responsible leader of the team. It is the individual under whose direction the research conducted.
Research subject is a patient or healthy volunteer from whom the PI conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.
1. Seek and obtain approval of the research protocol and informed consent document from the IRB prior to the collection of data.
2. Obtain written informed consent from all subjects in the research protocol, except in those cases where specific written informed consent is not required because the protocol has been exempted in advance by the IRB.
NOTE: THE RESPONSIBILITY FOR OBTAINING WRITTEN INFORMED CONSENT CANNOT BE DELEGATED.
3. Prior to the collection of any data, discuss the research protocol with the subject. At a minimum, provide the following information to the subject:
a. A statement that the study involves research, an explanation of the purpose of the research, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
b. A description of any reasonably foreseeable risks or discomforts to the subject;
c. A description of the potential benefits to the subject or to others, which may reasonably be expected from the research or a statement that no benefits are expected.
d. A disclosure of appropriate alternative procedures, if any, that might be advantageous to the subject;
e. A statement describing the extent to which the confidentiality of records identifying the subject will be maintained;
f. A statement that the subject’s refusal to participate in the research study will not jeopardize the subject’s receiving medical treatment at UICMC;
g. A statement that the subject’s consent, once given, may be withdrawn at any time;
h. A statement noting whether compensation is available and whether any medical treatment is available if injury occurs and if so, who to contact in the event of a research related injury;
i. A clarification that costs of treatment (i.e. those entirely outside of the research protocol) are the responsibility of the subject; and
j. A notice of a contact for questions regarding the research protocol and the research subject’s rights.
4. Have subject or subject’s legally authorized representative (or the parent if the subject is under 18 years old unless the minor subject is legally considered an adult) sign the informed consent document in own presence.
NOTE: A witness who was present at the signing of the informed consent document and the PI must also sign the form. If a minor subject is age 12 or older, his or her assent should be obtained in addition to the consent of the minor subject’s parents or legally authorized representative.
5. Place one copy of the signed informed consent document in the patient’s medical record and record a statement in the progress notes that the informed consent discussion occurred and that the consent was obtained. Give a copy of the informed consent document to the subject. Retain the original, signed informed consent document.
NOTE: When the Center for MR Research is only providing imaging services for another Investigator’s research protocol, a copy of the appropriately executed Informed Consent Form and a copy of the Center for MR Research Patient Safety screening form will be kept in a file established for that protocol. THE PI OR HIS CO-INVESTIGATOR NOT CENTER FOR MR RESEARCH STAFF IS RESPONSIBLE FOR THE INFORMED CONSENT PROCESS PRIOR TO SCANNING.
6. In the extremely rare circumstance, if the informed consent discussion did not occur or if the written informed consent document was not signed, notify the IRB within 5 working days regarding the circumstances associated with the failure to obtain the subject’s consent.
7. If any medication is to be given to or procedures performed on a subject who is a patient at UICMC for other reasons as part of the research protocol, inform the attending physician with primary responsibility for that patient’s care. The responsible attending physician must write orders accordingly. These experimental procedures shall be charted in the patient’s medical record in a manner consistent with other procedures (HMPP TX 2.06 Use and Control of Investigational Drugs.)
Policy 3: Research Time Billing Procedures
Research scanner time will be billed by the Grant Administrator. Only those researchers with approved funded research accounts will be allowed to schedule research scanner time.
1. Each Researcher will be assigned an internal research account number for each study undertaken. This number is used in scheduling scanner time in a minimum of 60 minute increments.
2. The MR Research Technologist records the amount of time used on the daily report and in the MR record book for each study.
3. The report is turned in to the Grant Administrator on a daily basis.
4. The Grant Administrator records the amount of time used by account.
5. The Grant Administrator generates a bill using the departmental accounting system on a monthly basis to each researcher.
Policy 4: Billing Procedure for Medications/Drugs Utilized for Research
All medications and drugs utilized in the studies performed on the 3T scanner must be paid for by the researcher whose subject they are used on. Note: Contrast media is billable to the Research Account.
1. An accounting of all medications/drugs will be maintained by the Clinical Research Coordinator (See Safety section Policy 9).
2. Drugs/Medications will only be prepared at the time they are to be administered. All drugs and doses will be entered in the research record for the individual subject.
3. For Outpatient research studies, the Clinical Research Coordinator will prepare a prescription form indicating the name of medication, dosage, means of administration, date, patient’s name, UIC Medical Record number, and Center for MR Research account number. This will be signed by the Director of the Center for MR Research with his DEA number indicated. The Clinical Research Coordinator will reorder stock supply as necessary. The completed prescription will be given to the Center for MR Research Administrator for billing to the appropriate research account.
4. For Inpatient research studies, the same procedure will be followed as for Outpatient research studies, but a note will be made to the Inpatient medical record by the Clinical Research Coordinator indicating medication (name, dose, route of administration, time of administration).
Policy 5: Research Access to Synchronization Control System (SCS) projection system
It is the policy of the Center for MR Research to facilitate the successful utilization of all functional data producing equipment.
Signal input to the projector is provided through a type D-subminiature, high-density (HD) 15-pin female, VGA graphics connector. This connection is located on the front panel of the Research Access Switch Box located in the SCS rack. This common connection is able to connect to all standard laptops and desktops, via standard VGA graphics cables, which have HD 15 pin male connections. All input signals should be formatted for 640×480 resolution and 60Hz refresh rate. Maximum projector capability is 24 bit, 16.7 million colors. The native resolution of the projector is 640 x 480.
Sequence of Set Up
1) Carefully connect and secure the graphics cable to be used with the HD 15 pin connector. Connect the graphics source PC to the graphics cable and power up.
2) Press the button switch. The graphics from the source PC will be displayed by the projector after a short delay for signal synchronization.
3) Confirm that the resolution and other format details are correct for the projector display.
4) NOTE: The projector box is not to be opened. The projector lens is set for desired focus. If this – or any other – SCS display adjustments need to be altered during research:
a) Get permission from the MR Research Specialist to change settings.
b) Record these changes immediately in the 3.0T log book.
c) Return these settings to the prior state at the end of the research slot.
5) Upon completion of the research, remove the alternate graphics cable. Replace and secure the SCS graphics cable in the input connector.
6) Confirm with the MR Research Specialist that the system is operating correctly.
Policy 6: Scanner Usage Following Non-Human Subjects
Following studies on non-human primates, the scanner must be clear for one hour.
1. All surfaces must be cleaned and bleached including equipment, tables, scanner bed, etc.
2. Human subjects are not to be scheduled for one hour after a primate has been scanned.
3. The air circulation must be turned over four times after a primate has been scanned before a human subject may go into the scanner. It takes one hour for the air circulation to be turned over four times.
Policy 7: CMRR Research Contrast Usage Policy
Contrast usage is to be tracked and reimbursements to the Clinical Department for Contrast will be reported on a monthly basis.
1. The 3T Technologists (Research Specialists in Health Sciences) should list the unit of dosage of Contrast used for each subject on the day sheets. This should be an amount such as 10, 15, 20, 50, etc.
2. The unit of dosage per subject should be entered into the 3T database by either 3T Technologist. At the beginning of every month, the Contrast usage for the previous month should be printed out and given to the Business Administrator (Assistant to the Director).
3. A copy of the day sheet should be given to the Coordinator of Administrative Services at the end of every working day.
4. The Coordinator of Administrative Services will input the contrast usage amount for each subject from the day sheets as well as other pertinent information into QuickBooks the following day.
5. In the beginning of every month the Business Administrator will generate a report of the dosages of contrast used for the previous month along with the costs. The Business Administrator will send an email to the Assistant Director of Radiology (Sherry Rodgers), Sherry’s administrator, and the Director of the Center for MR Research (Dr. Keith Thulborn) with the quantity and cost of Contrast that we should reimburse the Clinical Department for.
6. The amount of funds withdrawn by the Clinical Department for Contrast should be checked by the Business Administrator when he/she does monthly reconciliation of the accounts.
Policy 8: Research Subject Recruiting
All research subjects shall be recruited using only IRB approved documentation and procedures.
1) All documents distributed to potential research subjects must have an unexpired IRB approval stamp.
2) All subjects shall be recruited for a study using methods approved by the IRB for that study.
Policy 9: 9.4T Scanner Access
It is the policy of the Center for MR Research that all users of the 9.4T MR scanner have approval from the Director prior to use. Approval is obtained by completing the “9.4T Scanner Authorization” form. This form is not valid until it is signed by the Director of the CMRR.
Policy 10: 9.4T System Monitoring
It is the policy of the Center for MR Research that the 9.4T MR scanner be monitored at all times. Anyone receiving an alarm from the automated monitoring system must respond to it by following the Alarm Response Procedure. On-site alarm response personnel (OSARP) are on-call 24 hours a day to respond to alarms on-site. When a member of OSARP cannot be available for an on-site response (e.g., travel), he or she is responsible for making arrangements with the other OSARP members to ensure coverage. These instructions are posted in the CMRR at each alarm response site.
Alarm Response Procedure – if you receive an alarm do the following:
1) Log onto http://status94.cmrr.uic.edu to view the current system status. If you do not know your login credentials send an email to firstname.lastname@example.org (It may take up to 72 hours to get login credentials. If you need these request them NOW, not when there is an alarm).
2) Report the alarm to the designated CMRR personnel by telephone for on-site alarm response. If you cannot reach any of the contacts, you must respond to the alarm on-site.
CMRR On-Site Alarm Response Contact Order
- Ian Atkinson
- Keith Thulborn
- Ted Claiborne
- Aiming Lu
Standard On-Site Alarm Responses – Follow these procedures when responding to an alarm on-site.
- = equipment and action location marked with orange dot. The 9.4T equipment room (room 1316) has a map of all equipment and zones on the inside of the door.
Zone 1: Gradient Coolant Temp (CH-1) or Zone 2: Gradient Amp Coolant Temp (CH-2)
- Stop any active scan
- Turn off high-voltage to gradient amplifiers (rocker switch labeled turn off switch inside gradient amplifier cabinet •)
- Open back of gradient amplifier cabinet to break interlock ( •)
- Turn off RF amplifiers (two dial switches labeled turn off switch inside RF amplifier cabinet •)
- Turn off gradient amplifier chiller (CH-1) flow (move lever counter clockwise to flow off• )
- Turn off gradient amplifier chiller (CH-1) (rocker switch labeled turn off switch on front panel •)
- Turn off gradient coil chiller (CH-2) flow (move lever counter clockwise to flow off• )
- Turn off gradient coil chiller (CH-2) (rocker switch labeled turn off switch on front panel •)
- Report error to Anchor Mechanical by telephone (contact below)
- Report error to Center Director and 9.4T Manager
Zone 3: Gradient Coil Temp
- Stop any active scan
- Turn off high-voltage to gradient amplifiers (rocker switch labeled turn off switch inside gradient amplifier cabinet •)
- Open back of gradient amplifier cabinet to break interlock ( •)
- Turn off RF amplifiers (two dial switches labeled turn off switch inside RF amplifier cabinet •)
- Report error to Center Director and 9.4T Manager
Zone 4: Coolpak Chiller / Water Bypass
- Verify coolpak #1 and coolpak #2 are operating (needle should be at position indicated on signs above coolpaks)
- Report error to Anchor Mechanical by telephone (contact below)
- Report error to Center Director and 9.4T Manager
Zone 5: Coolpak # 1 or Zone 6: Coolpak # 2
- Press “SELECT” and record the fault displayed on the LCD
- Attempt restart failed coolpak by pressing “OFF” and then “ON” buttons on front panel ( • )
- Report error to Independence Cryogenic Engineering by telephone (contact below)
- Report error to Center Director and 9.4T Manager
Independence Cryogenic Engineering: Frank Hughes (email@example.com, 609-294-0012)
Anchor Mechanical: Stefan Noah (firstname.lastname@example.org, 708-870-7605)
Date: 2/11, Version: 1.0
Policy 1: Staff Safety
It is the policy of the Center for MR Research to provide guidelines for staff and faculty safety.
Staff should notify their supervisor of any changes in their medical history that could contraindicate working in an MR environment (e.g. heart condition, pregnancy, surgical implants, etc.).
All MR staff will be required to complete and sign the attached form “Screening Precautions” upon hire.
3. All staff and faculty that will experience more than one hour of echo planar imaging (EPI) per month must have a base line hearing test and another annually as long as they are experiencing more than one hour of echo planar imaging (EPI) per month. Reports will be sent to the Director for Human Resource files.
Policy 2: Designated Eating/Drinking Areas
It is the policy of the Center for MR Research to provide guidelines for the consumption of food and drink by the staff on work premises.
The only areas designated for food is the staff lounge and Conference Room.
As a courtesy, beverages should be limited to areas away from the patients, physicians or visitors. In addition, beverages are not permitted in the labs or scanning areas.
Policy 3: Dress Code
To assure professional appearance and instill patient confidence, the following dress code will be mandatory for all Center for MR Research personnel.
No staff member should be working in a patient care area without some type of hospital/professional attire. All staff members should report in clean, wrinkle free attire.
The following are not permitted to be worn while on duty: colored denim attire to include trousers, dresses, skirts, shirts/blouses, and overalls.
Designated support staff members are not required to wear lab coat and include computer programmers and the secretary.
A current UIC identification card should be displayed in compliance with UICMC policy.
Policy 4: Pregnant MR Staff
It is the policy of the Center for MR Research to provide pregnant staff with information in the form of procedural guidelines during the pregnancy period.
1. When a staff member who works in the Center for MR Research becomes pregnant, she must notify the Director or designated supervisor immediately when pregnancy is suspected or verified.
2. The staff member will be given a copy of her job description to take to her physician for evaluation to verify that she is able to perform the physical duties as specified. The physician’s response must be received within two to four weeks of notification of pregnancy to the department. If the physician’s response is not returned by the requested time, the staff member will be placed on unpaid leave of absence.
3. Once pregnancy is suspected, pregnant staff members (R.N., R.T.) are advised not to remain in the scanner room during the scanning. The technologist may operate the technologist console, film the exam or monitor the patient from the control room and enter the magnet room to position the patient in the imaging system, administer contrast/medication or evaluate patient’s condition as needed when scanning is off.
Policy 5: Unplanned Absence
It is the policy of the Center for MR Research to provide guidelines for staff members to report time off from duty for unanticipated reasons.
When reporting time off, the staff member must call in or email as soon as possible prior to the start of his/her work shift. This procedure should be followed for every day of absence. For absences of more than three days, staff must provide a doctor’s statement if time off is to be claimed as due to illness. The policies of the University of Illinois at Chicago will apply to all staff members.
For an extended illness, the Director or his appointee may adjust the frequency of the calls consistent with individual circumstances.
Policy 6: Planned Absence
It is the policy of the Center for MR Research to provide guidelines for staff members to schedule absences such that the functioning of the Center will be minimally impacted by staffing levels.
A completed request form (see http://chicago.medicine.uic.edu/research/cmrr/documentation_and_tools) will be completed and submitted to the Director for approval at least four weeks (30) calendar days before the absence will begin and at least an email forty-eight hours before the absence will begin. A face–to-face reminder of the pending absence would be appreciated so that any activities requiring immediate action can be completed prior to the absence.
All University of Illinois at Chicago Human Resource policies will be followed by the Center for MR Research.
Policy 7: Closing the Center
It is the policy of the Center for MR Research to provide guidelines for staff members to secure the building at end of the workday and on holidays. PROCEDURE Staff should not close the garage door separating CMRR from OCC before 5:30 pm unless you are the last person onsite and are leaving before 5:30 pm. This will allow easier access for custodians to clean CMRR. All faculty, staff and students should turn off all lights before leaving for the day.
Policy 1: Research Source Documents
The Center for MR Research understands the need for security and confidentiality of research source documents. All data storage devices (paper, diskettes, CD, Optical Disks, etc.) are kept in a locked cabinet to which only Center for MR Research Staff has access.
1. A file will be established for each human research subject (patient/healthy volunteer). This file will contain the Center for MR Research Safety Screening Questionnaire, the original Informed Consent Form, subject identification information for demographic database purposes, medical history available, TIF copies, dictated report hardcopy, payment vouchers if applicable, tracking sheet for each visit, and copies of any correspondence or notes on communication.
2. The files will be kept in a locked cabinet to which only the MR Research Staff has access. Files removed from the cabinet will be tracked by the Clinical Research Coordinator such that all files may be located at any given time.
3. A database of all research subjects will be maintained and kept secured by the Clinical Research Coordinator.
4. None of the source documents will be removed from the Center for MR Research at any time without the written consent of the Director of the Center or the IRB.
Policy 2: Confidentiality of Research Data
The Center for MR Research provides a service for many individual investigators. Since some of these investigators may be involved in similar research, the confidentiality of the individual investigators research data must be secured such that it cannot be used by anyone but the investigator or his/her designates.
The Center for MR Research staff will be responsible for moving data from the scanner to other storage devices on completion of the scans performed by the Center for MR Research staff in a timely fashion. The Staff will also be responsible for the security of any data storage media consistent with Good Clinical Practices.
If the Investigator or his/her designate performs the scan involved in their research, the Investigator or his/her designate is responsible for removing the information from the scanner workstation as soon as the scan is complete. The Center for MR Research will not be responsible for the confidentiality of the information left on the scanner after completion of the study.
Policy 3: Medical Records: Release of Information
The Center for MR Research restricts the release of medical information and medical records. (see HMP IM 4.03 Medical Records: Release of Information).
1. All requests for medical information must be in written form and accompanied by a properly executed Release of Medical Information Form signed by the Patient/Subject or their legally-authorized representative specifying the medical records to be released.
2. No medical information originating outside the Center for MR Research which may be contained in the Center for MR Research files may be released for any reason. The requester should be referred to original source.
3. If the requested information is contained in the Patient/Subject’s Medical Record at UICMC, the request and release should be forwarded to the Medical Records Department for response.
Policy 4: Subject: Internet Protocol (IP) Address
It is the policy of the Center for MR Research to secure all Patient/Subject information such that unauthorized access is not possible.
An Internet Protocol Address may not be added or given to staff not specifically allowed access to Patient/Subject data as part of their normal duties.
A non-Center employee may not have an IP address established without the written permission of the Director of the Center. A copy of the authorization with dates will be kept on file by the Network Analyst and Clinical Research Coordinator, responsible for Subject records.
Policy 5: Creating paradigm files for SCS
It is the policy of the Center for MR Research to facilitate the successful utilization of all functional data producing equipment. Consistency in the methodology used to create the data promotes this success.
1. All paradigms should be movie files, consisting of a series of frames to be played sequentially.
2. The resolution of the files should be standard VGA, that is, 640 pixels wide and 480 pixels high.
3. All movies should play at 30 frames per second, regardless of the rapidity of motion (or lack thereof) in them.
4. If color is used, the bit depth should be adjusted to 24 bits, providing 8 bits of resolution each in the red, green and blue channels. For paradigms without color, 2 bit or 8 bit grayscale may be used. Please choose 8 bit if possible, since anti-aliasing cannot be done at 2 bit depth.
5. Any software can be used to produce the movie files, however, we recommend Adobe Premiere.
6. If the movie files contain accompanying audio information, the maximum resolution permitted for audio is two channels at 16 bits and a sampling rate of 44.1 kHz.
7. Video Signal Encoding: this must be MPEG-2 only. No other encoding methods are acceptable. You may enclose the files in an AVI wrapper, proving that MPEG-2 was used as the encoding method. We recommend the MPEG-2 encoder included with Pinnacle DV500 Plus.
8. Audio Signal Encoding: this must be mp3 compatible. Variable or constant bit rates may be used, but the data stream should not average more than 64 kbits/s.
9. We recommend anti-aliasing if motion is present in the paradigm.
10. Microsoft Media Player is used to play the movie files in the SCS. However, Media Player can use many codecs, which may or may not be installed on our system. The fact that the movie plays in Media Player on your computer is no guarantee that it will play on the SCS. Please test your paradigm on the SCS at least a day or two before using it on a subject.
Policy 6: The limit for the disk space usage.
It is the policy of the Center for MR Research to limit the usage of free disk space on the CMRR Data Server for External Users.
Every effort is made to provide external users with as much disk space as they require. However, the total amount of disk space will always be limited and investigators should try to use only what is necessary.
The following quota has been set by the Center for MR Research:
External user accounts for each investigator: 10 Gigabytes
If you reach your quota you will not be able to create or extend files.
Investigators who require a larger quota should contact Ian Atkinson (email@example.com) to request a larger quota.
Policy 7: Inventory Tracking
It is the policy of the Center for MR Research to maintain an inventory of significant items.
When an item is received it shall be entered into the database. The database is located on the server and the network path is \\184.108.40.206\inventory which can be accessed by typing in the path in your internet browser.
Policy 8: Notification of maintenance to shared computing resources
Notification of maintenance to shared computing resources will be made to all affected users prior to performing maintenance.
1) Notification of planned maintenance that may affect availability of a shared computing resource (e.g., data server, network printer, computing cluster, license server, shared workstation, etc.) will be made to the entire department via email at least 48 hours prior to beginning maintenance. This notification will be repeated 1 hour before beginning maintenance. The notification will describe the maintenance to be performed, the need for the maintenance, the expected time to complete the maintenance, and the availability of the computing resource during maintenance.
2) Notification of unplanned (emergency) maintenance that may affect availability of a shared computing resource (e.g., data server, network printer, computing cluster, license server, shared workstation, etc.) will be made to the entire department via email at least 10 minutes prior to performing maintenance. The notification will describe the maintenance to be performed, the need for the maintenance, the expected time to complete the maintenance, and the availability of the computing resource during maintenance. If data availability will be affected, a verbal notification will also be made to the entire department to minimize the risk of data loss.