SUBJECT: ASSESSMENT OF LAB RESULTS PRIOR TO INJECTING GADOLINIUM-BASED CONTRAST MEDIA.

Transcription

1 ASSESSMENT OF PATIENTS: IMAGING SERVICES Policy #: Effective Date: 6/29/09 Last Revision Date: 10/07 Page 1 of 5 SUBJECT: ASSESSMENT OF LAB RESULTS PRIOR TO INJECTING GADOLINIUM-BASED CONTRAST MEDIA Is Background: Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) was first described in the medical literature in The first case of NSF/NFD was seen in The disease is seen in patients that have noticeably advanced renal failure. NSF has been reported only in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m 2 ) or patients with renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period. The disease is associated with increased tissue deposition of collagen, often resulting in thickening and tightening of the skin (predominantly the distal extremities and occasionally the trunk). Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility of the joints. In addition, patients may experience fibrosis that has spread to other parts of the body such as the diaphragm, heart, lungs pulmonary vasculature and skeletal muscles. The clinical course of NSF/NFD is progressive and may be fatal. SUBJECT: ASSESSMENT OF LAB RESULTS PRIOR TO INJECTING GADOLINIUM-BASED CONTRAST MEDIA. POLICY STATEMENT: Various exams provided by the Department of Diagnostic Imaging require the administration of intravascular (intravenous) gadolinium-based contrast media. GADOLINIUM-BASED CONTRAST MEDIA: Prior to the administration of gadolinium-based contrast media a Creatinine/GFR level will be obtained for each patient according to the following guidelines: 1

2 LABS WITHIN 30 DAYS The following patients must have a documented Creatinine/GFR within the past 30 days: 1) Patients greater than or equal to the age of 60 2) Patients with a history of diabetes 3) Patients with a history of high blood pressure (hypertension) 4) Patients with a history of kidney disease, kidney surgery, kidney tumor or who have a single kidney If creatinine/gfr is not documented: Obtain creatinine and calculate GFR If GFR is between ml/min/1.73m 2 (including 30 and 60) and patient is does not have a history of kidney transplant or patient is not on dialysis: Replace Omniscan with ½ the ordered dose of Multihance. If GFR is <30 ml/min/1.73m 2, contact appropriate radiologist for further orders prior to injecting gadolinium-based contrast (see additional criteria below for Notifying Radiologist). LABS DAY OF MRI SCAN (within 24 hours of MRI scan) The following patients must have a documented Creatinine/GFR on the day of MRI scan (within 24 hours of MRI scan): 1) All in-patients (including ER patients) 2) Patients whose most recent creatinine was elevated per OHSU hospital standards 3) Patients with a history of hepatic (liver) disease, liver transplant, pending liver transplant or patients in the perioperative period of liver transplant procedure (currently admitted pre/post surgical procedure). If creatinine/gfr is not documented: Obtain creatinine and calculate GFR If GFR is between ml/min/1.73m 2 (including 30 and 60) and patient is does not have a history of kidney transplant or patient is not on dialysis: Replace Omniscan with ½ the ordered dose of Multihance. If GFR is <30 ml/min/1.73m 2, contact appropriate radiologist for further orders prior to injecting gadolinium-based contrast (see additional criteria below for Notifying Radiologist). 2

3 RENAL TRANSPLANT PATIENTS LABS ON DAY OF MRI SCAN (within 24 hours of MRI scan) Patients with a history of renal transplant must have a documented Creatinine on the day of their MRI scan (within 24 hours of MRI scan). a. If creatinine is not documented, contact appropriate radiologist prior to drawing creatinine and determine need for creatinine. b. Calculate/obtain GFR if creatinine available. c. Contact appropriate radiologist prior to injecting gadolinium based contrast. Radiologist to confer with renal transplant physician prior to contrast administration if IV contrast is needed for diagnostic purposes. d. Radiologist to provide written order for contrast. e. Radiologist to obtain consent prior to contrast administration. f. If contrast is required: DO not use Omniscan. Replace Omniscan with ½ the ordered dose of Multihance (radiologist to confer with renal transplant physician, provide written order prior to giving IV contrast). PATIENTS WHO ARE ON HEMODIALYSIS OR PERITONEAL DIALYSIS: (no need to calculate GFR) a. Contact radiologist prior to injecting gadolinium based contrast. b. Radiologist to confer with nephrologists prior to contrast administration if IV contrast needed for diagnostic purposes. c. Radiologist to provide written order for contrast. d. Radiologist to obtain consent prior to contrast administration. e. If contrast is required: DO not use Omniscan. Replace Omniscan with ½ the ordered dose of Multihance (radiologist to confer with renal transplant physician, provide written order prior to giving IV contrast). ***If patient is on hemodialysis and will be receiving IV gadolinium based contrast (per appropriate radiologist s written order), assure prompt dialysis following injection of contrast. Patient should have a minimum of 2 dialysis sessions within 24 hours of any MRI study in which the patient receives gadolinium based contrast. a) The first dialysis session should be within 2 hours of MR studies using gadoliniumbased contrast. b) The second dialysis session should be within 24 hours of MR studies using gadolinium-based contrast. ***If patient is on peritoneal dialysis and will be receiving IV gadolinium-based contrast (per appropriate radiologist s written order), nephrologists to provide recommendations for post MRI care. If patient requires hemodialysis: follow dialysis instructions above (first dialysis session should be within 2 hours of MR study, second dialysis session should be within 24 hours of MR study). 3

4 The radiologist will obtain informed consent for any of the following patients who will be receiving IV gadolinium: 1) Patients with a GFR < 30. 2) Patients on dialysis. 3) Renal transplant patients. 4) Patient is in perioperative period of liver transplant procedure (currently admitted pre/post surgical procedure). 5) Patient is a liver transplant patient or pending liver transplant patient and GFR is less than 60 ml/min/1.73m 2 **The MRI technologist or RN will provide written discharge instructions to all patients who require informed consent for a MRI study in which they received IV gadolinium-based contrast (patients with a GFR < 30, patients on dialysis, renal transplant patients), pending liver transplant patient, Patient is in perioperative period of liver transplant procedure (currently admitted pre/post surgical procedure). CRITERIA FOR NOTIFYING RADIOLOGIST - THE TECHNOLOGIST OR RN WILL NOTIFY THE RADIOLOGIST IF: 1) Patient is receiving a gadolinium enhanced MRI for renal tumor or liver tumor follow-up. 2) Patient is on dialysis. 3) Patient has a history of kidney transplant. 4) Patient is a pending liver transplant patient. 5) Patient is in perioperative period of liver transplant procedure (currently admitted pre/post surgical procedure). 6) GFR <30 ml/min/1.73m 2 7) Patient has a single kidney. 8) Patient has had/will be having a CT scan with contrast within 24 hours of a gadolinium enhanced MRI. 9) Patient received gadolinium based contrast media within the past 24 hours. 10) For questions related to kidney or liver function. 11) Patient is allergic to gadolinium or patient has not been pre-medicated for allergy per OHSU Imaging Department Protocol. 12) Patient reports anaphylactic response to MRI contrast (including those patient s pre-medicated per Imaging Department Protocol). 4

5 CALCULATING GFR (GLOMERULAR FILTRATION RATE) FROM AVAILABLE CREATININE: Adults: Pediatric patients: Document GFR in the designated area of the MRI Patient Information Form/ Procedure Record. GFR to be documented on the MRI Patient Information Form/ Procedure Record prior to the administration of any gadolinium-based contrast agent for those patients that require GFR calculation. MRI Patient Information Form/ Procedure Record to be incorporated into the patient s medical record. CREATININE PROVIDED BY OUTSIDE FACILITIES The PAS staff, technologist or RN will photocopy any documented Creatinine level that the patient may provide from an outside facility and attach the results to the appropriate Patient Information Form. The lab information will be incorporated into the patient s medical record. Outside facilities may FAX a documented copy of the patient s Creatinine results to the OHSU radiology department at (503) The faxed document will be attached to the Patient Information Form and incorporated into the patient s medical record. *Documented lab results shall include any results that are available in the OHSU electronic database, a copy of the official lab report from an outside facility, a faxed copy of the official lab report from an outside facility or documentation signed by the referring physician indicating the patient s Creatinine level and the date labs were drawn. References: ACR Guidance Document for Safe MR Practices: AJR 2007 p FDA Information for Healthcare Professionals: Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging Scans. December, U.S. Food and Drug Administration: Information on Gadolinium-Containing Contrast Agents. Date created: June 8, 2006; updated May 23, 2007 Related forms and Procedures: OHSU Imaging Services; MRI Patient Information Form/Procedure Record OHSU Imaging Services; Discharge Instructions For MRI Patients Receiving Intravenous Gadolinium Contrast OHSU Imaging Services; MRI Informed Consent for Use of Gadolinium in Patients with Renal Insufficiency of Renal Failure Replaces: New Originator: Imaging Services 5

6 Updates: From: Rebecca Rotenberg Sent: Thu 7/9/2009 3:29 PM To: Amy McCullar; Gloria Hardt; Gretchen Boylan; Gunnar Sharp; Irene Neuman; Janelle Walch; Janie Boxer; Julie Bachman; Kim Brolutti; Laurie Weigel; Maryann Parris; Rebecca Rotenberg; Rebecca Winters; Sherri Benedetti; Tricia White Cc: Wayne Smith Subject: Pending liver tsp NSF Thank you all for your help as we work to implement the new NSF policy. Please note: The recommendation for contacting the radiologist if the patient is a pending liver transplant patient has been removed from the policy, please continue to draw lab work according to policy (within 24 hours of scan). We will continue to contact the rad and obtain consent if the patient is in the perioperative period of liver transplant procedure (currently admitted pre/post surgical procedure). 6