Guidelines and Policies for Safe Imaging Practice at UCSF. Christopher P. Hess, M.D., Ph.D.

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1 Guidelines and Policies for Safe Imaging Practice at UCSF Christopher P. Hess, M.D., Ph.D.

2 The following cases are (sort of) true. The names have been changed to protect the innocent.

3 CASE 1 A patient with mild renal insufficiency and laryngeal cancer is scheduled for staging MRI (GFR 42). She has a cochlear implant, and a history of being shot in the abdomen. She recently had a spine MRI with no issues. An MRI is obtained without gadolinium due to CKD. A complaint is filed because her implant is no longer functional.

4 CASE 1: DISCUSSION Who is responsible for screening patients? Was it safe to have MRI with a cochlear implant? Shrapnel? Should this patient have received IV gadolinium contrast? What are the risks of IV gadolinium contrast?

5 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy

6 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy 1. Completed by patient or provider in discussion with patient, close family member or caretaker 2. Reviewed by MRI tech 3. Escalated when necessary to radiologists

7 What if a patient cannot be screened? 1. Radiologist and ordering attending approval 2. Chest and KUB (CT if necessary) 3. Screening orbits CT + scout (or brain CT)

8 YES

9 NO

10 MAYBE

11 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy Established Guidelines for Most Common Devices: 1. Pacemakers, ICDs, DBS - can be done safely using SOP 2. Coronary stents - all ok at 3T if > 6 weeks 3. Epicardial pacer wires - must be cut or removed 4. Aneurysm clips - any placed at UCSF since Drug infusion pumps - usually safe following SOP mri#accordion-what-can-go-into-the-magnet?

12 Prior uneventful MRI is not adequate justification for bypassing safety protocols in subsequent MRI

13 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy Potential Risks of Gadolinium Chelates: 1. Allergic reactions % of patients (anaphylaxis rate % of patients) 2. Nephrogenic systemic fibrosis (NSF) 3. Brain stain (??)

14 May 23, 2007

15 Macrocyclic Agents: Pooling literature and registry data from many thousands of injections in patients with egfr<30, the risk of NSF is less than 1/2000. With egfr >40, NSF has never been reported at any center in the world.

16 >40 Use as clinically indicated egfr* Recheck GFR Dose adjust <30 Avoid use of IV gad Only if absolutely necessary, requires informed consent and attending approval * within 1 day for patients on transplant list or recently transplanted, otherwise within 6 weeks

17 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy History - Abdominal pain

18 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy 1. FDA, ACR - citing animal studies of possible teratogenic risk and injury to fetal hearing, the safety of MRI has not been established 2. UCSF approach: Use ultrasound if possible, but do not withhold MRI if clinically necessary (MRI almost always better than CT)

19 1. MRI SAFETY Screening Implanted devices Gadolinium Pregnancy 3. Intravenous gadolinium is FDA category C to be avoided in pregnancy given theoretical teratogenic risk, especially in first trimester 4. But should not be withheld if absolutely essential - requires informed consent and attending approval 5. No need to withhold breastfeeding after gad

20 CASE 2 A patient in the ED undergoes CTA for suspected dissection. Based on the preliminary read, the patient is discharged: No dissection, the aorta and its branch vessels are patent. No aneurysmal dilation. 4 mm right upper lobe noncalcified nodule, otherwise clear Low attenuating lesions liver and kidney, too small to characterize. Prior inguinal hernia repair. [ 30 lines ] Discussed with Dr. Smith.

21 CASE 2 One year later, a chest CT obtained for workup of cough shows stage IV lung cancer.

22 CASE 2: DISCUSSION When should the wet read module be used? Why was appropriate follow-up not performed? What findings on imaging warrant direct communication?

23 2. COMMUNICATION Prelim reads When? How? Documentation

24 2. COMMUNICATION Prelim reads When? How? Documentation Goals for wet reads* 1. Succinct and clear 2. Actionable 3. Auditable *The wet read module serves as documentation, and should be used for effective handoffs in care.

25 2. COMMUNICATION Prelim reads When? How? Documentation 2015 WET READ STATS 1. Major discrepancy in 0.29% of CT studies (literature benchmark 1-2.3%) 2. Minor in 3.3% (literature benchmark 3-7%) *The wet read module serves as documentation, and should be used for effective handoffs in care.

26 2. COMMUNICATION Prelim reads When? How? Documentation 1. New or unexpected - when the findings could result in mortality or significant morbidity and/or alter a patient s short- or long-term management 2. Discrepant - when the final interpretation differs from preliminary enough to alter management 3. Recommendation - when the impression includes a recommendation for further evaluation or follow-up

27 EMERGENT In person or phone call STAT page URGENT In person or phone call Routine page NON-URGENT In person or phone call Routine page or Apex (w/ response) Relay center

28 2. COMMUNICATION Prelim reads When? How? Documentation STAT Page - Prefix 911 to Callback

29 Relay Center //ALERT// Allows electronic identification of follow-up cases Administrative staff contact ordering and PMD 2015 statistics: 3812 reports flagged with subcritical alerts Ordering provider contacted in 99.8% of cases PMD contacted in 85.7% of cases New: Use //ALERT// at end of reports followed by impression numbers that require communication, i.e. //ALERT// 2,3

30 2. COMMUNICATION Prelim reads When? How? Documentation 1. Clarity and transparency are key Must include required elements Accurately identify what was communicated Document changes to wet reads 2. Use PS360 Macros Communication Overread

31 CASE 3 A patient with right-sided sciatica undergoes a nerve root block. He reports no relief following the injection. 2 weeks later he develops fevers and increasing low back pain. An MRI is performed.

32 CASE 3 R L

33 CASE 3

34 CASE 3: DISCUSSION What are the elements of an appropriate timeout? What are the requirements for trainee supervision? How should adverse events be handled?

35 COMMUNICATION 3. SYSTEMS Supervision Timeout Quality assurance Managing risk

36 3. COMMUNICATION SYSTEMS Supervision Timeout Quality assurance Managing risk CMS must be physically present for the critical or key portions of these services ACGME is available to provide review of procedures/encounters

38 COMMUNICATION 3. SYSTEMS Supervision Timeout Quality assurance Managing risk

39 COMMUNICATION 3. SYSTEMS Supervision Timeout Quality assurance Managing risk Separate resident and section QA M&M conferences held for review of important cases with subtle findings, tough diagnoses, technical issues, systems problems Conferences structures for learning and identification of solutions (not public flogging)

40 COMMUNICATION 3. SYSTEMS Supervision Timeout Quality assurance Managing risk Events reportable to the state - excessive dose or wrong body part (exceeding dose), wrong procedure/patient Disclosure of errors is a must, but get help Never try to whitewash the medical record, or use the medical record to opine on others judgement Refer cases for section QA Confer with attending/section chief/quality chair Consult with risk management early

41 Resources DEPARTMENTAL QUALITY & SAFETY LEADERSHIP AI - Spencer Behr, MD Chest - Karen Ordovas, MD IR - Bob Kerlan, MD Mammo - Heather Greenwood, MD MSK - Thomas Link, MD Neuro - Christine Glastonbury, MD NeuroIR - Dan Cooke, MD Nucs - Miguel Pampaloni, MD Peds - Andrew Phelps, MD US - Vickie Feldstein, MD Charlene Fong, RN Radiology Safety Nurse Benjamin Mow, RT Chief MR Technologist Michael Hope, MD MR Safety Committee Chair Ronald Zagoria, MD Operations Chair Christopher Hess, MD, PhD Quality & Safety Chair

42 Resources USEFUL WEBSITES & DOCUMENTS UCSF Radiology Website ACR Practice Parameter for Communication of Diagnostic Imaging Findings ACR Manual on Contrast Media (version 10.2, 2016)

MRI Patient Screening and History

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