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
Email [email protected]
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.
Policy 2: Subject 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 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.