Lior - Bracco Radiology Symposia Booklet

www.ismp.org
Improving Medication Safety
in the Radiology Setting
Breakfast Symposium
Monday, December 8, 2014
This symposium is funded through
an educational grant from
Bracco Diagnostics.
A breakfast symposium conducted at the
49th ASHP Midyear Clinical Meeting and Exhibition

Improving Medication Safety in the Radiology Setting
© 2014 Institute for Safe Medication Practices
AGENDA
11:30 AM – 11:40 AM
6:15 AM – 6:45 AM Breakfast
11:30 AM – 11:40 AM
6:45 AM – 6:55 AM Welcome and Introductions
Janice Dunsavage, RPh, MAS
Director of Pharmacy, PinnacleHealth, Harrisburg, PA
Chair, Board of Directors, Institute for Safe Medication Practices
(ISMP), Horsham, Pennsylvania
6:55 AM – 7:25 AM
Primer on Medication Administration Systems and
Medications Used in Radiology
Lior Molvin, (MBA) (RT) (R) (CT)
CT Protocol Technologist, CT Protocol
Development and Education Team, Stanford University Medical
Center and Stanford Medicine, Imaging Center, Palo Alto, CA
7:25 AM – 8:00 AM Medication Safety Issues and Recommended Strategies
Matthew P. Fricker, Jr., MS, RPh, FASHP
Program Director, Institute for Safe Medication Practices (ISMP)
Horsham, Pennsylvania
8:00 AM – 8:35 AM
Centers for Medicare & Medicaid Services (CMS) and
The Joint Commission Requirements
Darryl S. Rich, PharmD, MBA, FASHP
Medication Safety Specialist, Institute for Safe Medication
Practices (ISMP)
8:35 AM – 8:45 AM Question and Answer Session
8:45 AM Adjourn
1

FACULTY INFORMATION
Janice M. Dunsavage, RPh, MAS
Director of Pharmacy, PinnacleHealth
Harrisburg, PA
Janice M. Dunsavage, RPh, MAS, received a BS in pharmacy degree from the Philadelphia College of
Pharmacy and Science, now the University of the Sciences in Philadelphia, and a Master of Administrative
Science degree from Johns Hopkins University. Her past employment includes various positions at the Johns
Hopkins Hospital and Sinai Hospital in Baltimore, MD. She has served on the Board of Directors of both the
Maryland and Pennsylvania Societies of Health System Pharmacists. She has also served for many years in
the House of Delegates as well as on several councils of the American Society of Health System Pharmacists.
Janice has been a representative on the Pennsylvania State Patient Safety Collaborative. Presently she is
serving on the Joint State Government Commission’s Advisory Committee on Opioid Addiction in Pennsylvania.
Ms. Dunsavage is currently the System Director of Pharmacy for PinnacleHealth in Harrisburg, PA, a position
she has held for 19 years. She has served on the Board of Trustees for the Institute for Safe Medication
Practices since 2001, currently as Chair.
Lior Molvin, (MBA) (RT) (R) (CT)
CT Protocol Technologist, CT Protocol Development and Education Team
Stanford University Medical Center and Stanford Medicine, Imaging Center
Palo Alto, CA
Lior Molvin is currently the lead CT Protocol technologist at Stanford Hospital and Clinics. Lior was trained at
Mills Peninsula School of Radiologic Technology where he completed his training as a Radiologic Technologist
from 2004-2006. Lior studied biology while working prior to attending a school of Radiologic Technology. Lior
furthered his education studying healthcare administration in his undergraduate degree, and recently Lior
completed his MBA in 2014. In 2006, Lior started his career at Stanford University where he rotated through all
shifts and developed his keen interest for CT technology. In 2008, Lior Molvin was the key technologists to staff
a new outpatient imaging center equipped with, and continuously updated with, the latest CT technology from
two major vendors. The challenges of developing new protocols for new and evolving applications, close
interaction with subspecialty radiologists, researchers, and the CT manufacturers are the basis of his unique
practical CT expertise, which he is sharing with others through many educational efforts. In his current role Lior
is charged with developing, implementing, and maintaining CT protocols enterprise-wide on all inpatient and
outpatient scanners. He is also closely involved and co-developer of the Stanford Dose Monitoring Program,
which records and benchmarks each diagnostic CT acquisition within and across the Department of Radiology.
Lior is a key participant in the Stanford CT Technologist Training and Education program. Lior is a sought-after
speaker and has lectured on CT and contrast medium topics locally and nation-wide. For his contributions to
Stanford Radiology, Lior was awarded the Technologist of the Year in 2013.
2

Medication Safety Specialist, Institute for Safe Medication Practices
Horsham, PA
Prior to joining ISMP, Darryl Rich was a surveyor for The Joint Commission in the hospital, home care, and
ambulatory accreditation programs. In addition, he worked for the Standards Interpretation Group serving as an
internal resource for The Joint Commission related to pharmacy and medication management . Dr. Rich served
as Field Director for Surveyor Management and Development at The Joint Commission prior to becoming a
surveyor. Before starting at The Joint Commission in 1993, Dr. Rich was National Director of Pharmacy
Services for Critical Care America, Inc., a national home infusion company. He previously served as Director of
Pharmacy Services at Boston University Medical Center and Clinical Assistant Professor of Pharmacy at
Northeastern University. Dr. Rich is an active member and Fellow in the American Society of Health System
Pharmacists and a past President of the New England Council of Health-System Pharmacists. He has received
numerous awards, given over 640 invited presentations and has authored 76 publications in refereed journals,
including eight books and four video series. Dr. Rich received his Bachelor of Science from The University of
California at Davis, his Doctor of Pharmacy degree from the University of California at San Francisco and a
Master’s in Business Administration in Health Care Management from Bryant University in Rhode Island.
Matthew P. Fricker, Jr, MS, RPh, FASHP
Program Director, Institute for Safe Medication Practices
Horsham, PA
Prior to joining ISMP, Matt was employed in the acute care setting for over 27 years, most recently as director of
pharmacy and materials management and Institutional Review Board chairman. In addition to performing onsite
medication safety risk assessments and speaking about medication safety in hospitals throughout the United
States, he has managed several medication safety collaboratives designed to improve safety with high alert
drugs, including anticoagulants and opioids. Matt created program tools and content for the Regional Medication
Safety Program for Hospitals, a collaborative program with the Health Care Improvement Foundation of the
Delaware Valley Healthcare Council and ECRI Institute. He has also co-developed medication safety programs
for critical access hospitals in Pennsylvania and throughout the US. Matt received his BS in Pharmacy and MS
in Hospital Pharmacy Administration from Temple University and has published numerous articles in the
pharmacy and medical literature.
3

ACTIVITY OVERVIEW
Radiology departments often use medications in ways that are different from other clinical areas of the hospital,
and staff may not be aware of the significant safety issues that can arise. This symposium will explore current
medication safety issues in the radiology setting, such the safe use of contrast, appropriate labeling of
containers, beyond-use dating, and patient identification. Nationally known experts will discuss actual cases
where errors have occurred and risk reduction strategies, including use of technology and best practices. A new
Imaging Bulk Package for contrast recently approved by the FDA as well as the regulatory and Joint
Commission accreditation requirements for use of contrast and other medications in radiology will also be
discussed.
OBJECTIVES
The target audience for this activity includes pharmacists in health-system settings. At the completion of this
symposium, the participant should be able to:
 Describe how medications and contrast agents are ordered, stored, prepared, and utilized in the
radiology setting.
 Explain the difference between the new FDA classification of an imaging bulk package vs. a pharmacy
bulk package of contrast, and why the FDA developed this new product type.
 Identify system-based causes of medication errors associated with the use of medications and contrast
agents in radiology.
 Prioritize selected strategies to prevent harm and improve medication safety in radiology.
 Describe current regulatory and accreditation requirements related to the use of medications and
contrast agents in radiology, and the role of the pharmacy in assuring compliance to the standards.
4

The Institute for Safe Medication Practices (ISMP) is the nation’s only nonprofit, charitable organization
dedicated entirely to medication error prevention and safe medication use. ISMP is known and respected
worldwide as the leading resource for independent and effective medication safety recommendations. The
Institute’s strategies are based on up-to-the minute information gained from analysis of reports to the voluntary
ISMP National Medication Errors Reporting Program and onsite visits to individual healthcare organizations.
ISMP’s highly effective initiatives, which are built upon system-based solutions, include: five medication safety
newsletters for healthcare professionals and consumers that reach more than three million total readers;
educational programs, including conferences on medication use issues; confidential consultation services to
healthcare systems to proactively evaluate medication systems or analyze medication-related sentinel events;
advocacy for the adoption of safe medication standards by accrediting bodies, manufacturers, policy makers and
regulatory agencies; independent research on evidence-based safe medication practices; and a consumer
website (www.consumermedsafety.org) that provides patients with access to free medication safety information
and alerts.
ISMP works with healthcare practitioners and institutions, regulatory and accrediting agencies, consumers,
professional organizations, the pharmaceutical industry, and others to accomplish its mission. It is a federally
certified patient safety organization (PSO), providing legal protection and confidentiality for patient safety data
and error reports it receives.
As an independent nonprofit, ISMP receives no advertising revenue and depends entirely on charitable
donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its lifesaving work. For
more information or to make a donation that will make a difference to patient safety, visit ISMP online at
www.ismp.org.
5

CCOONNTTIINNUUIINNGG EEDDUUCCAATTIIOONN IINNFFOORRMMAATTIIOONN
This CE activity is jointly provided by ProCE, Inc. and the Institute for Safe Medication Practices (ISMP). ProCE
is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy
education. ACPE Universal Activity Number 0221-9999-14-227-L05-P has been assigned to this knowledge-
based live CE activity (initial release date December 8, 2014). This CE activity is approved for 2.0 contact hours
(0.20 CEUs) in states that recognize ACPE providers. This CE activity is provided at no cost to participants.
Successful completion of the online post-test and evaluation at www.ProCE.com no later than January 9, 2015
is required to receive CE credit. CE credit will be automatically uploaded to NABP/CPE Monitor within 1 to 2
weeks of the completion of the post-test and evaluation. No partial credit will be given.
It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its
continuing education activities. Faculty must disclose to participants the existence of any significant financial
interest or any other relationship with the manufacturer of any commercial product(s) discussed in an
educational presentation. The following staff and speakers have disclosed that they do not have any financial
arrangements or affiliations with corporate organizations that either provide educational grants to this program
or may be referenced in this activity. Furthermore, the below-referenced speakers have also attested that their
discussions will not include any unapproved or off-label use of products.
Janice Dunsavage, RPh, MAS,
Lior Molvin, (MBA) (RT) (R) (CT),
Matthew P. Fricker, Jr, MS, RPh, FASHP
Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider.
The information and views are those of the faculty through clinical practice and knowledge of the professional
literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of
labeling should be considered experimental and participants are advised to consult prescribing information and
professional literature.
6

CE Activity Information & Accreditation
2
This CE activity is jointly provided by ProCE, Inc. and the Institute for Safe
Medication Practices (ISMP). ProCE is accredited by the Accreditation Council
for Pharmacy Education as a provider of continuing pharmacy education.
This CE activity is approved for 2.0 contact hours (0.2 CEUs) in states that
recognize ACPE providers.
Disclosure
3
It is the policy of ISMP and ProCE, Inc. to ensure balance, independence,
objectivity and scientific rigor in all of its continuing education activities. Faculty
must disclose to participants the existence of any significant financial interest or
any other relationship with the manufacturer of any commercial product(s)
discussed in an educational presentation.
Today’s speakers have no relevant commercial and/or financial
relationships to disclose.
Please note: The opinions expressed in this activity should not be construed as
those of the CME/CE provider. The information and views are those of the
faculty through clinical practice and knowledge of the professional literature.
Portions of this activity may include unlabeled indications. Use of drugs and
devices outside of labeling should be considered experimental and participants
are advised to consult prescribing information and professional literature.
7

Online Evaluation and Statement of Completion
• www.ProCE.com
• Register with
username and
password
• Deadline:
Friday, January 9
4
Event Code = ??????Event Code = ??????
Objectives
The target audience for this activity includes pharmacists in health-system
settings. At the completion of this symposium, the participant should be able to:
• Describe how medications and contrast agents are ordered, stored,
prepared, and utilized in the radiology setting.
• Explain the difference between the new FDA classification of an imaging
bulk package vs. a pharmacy bulk package of contrast, and why the FDA
developed this new product type.
• Identify system-based causes of medication errors associated with the use
of medications and contrast agents in radiology.
• Prioritize selected strategies to prevent harm and improve medication safety
in radiology.
• Describe current regulatory and accreditation requirements related to the
use of medications and contrast agents in radiology, and the role of the
pharmacy in assuring compliance to the standards.
5
6
Primer on Medication
Administration Systems and
Medication Used in Radiology
Lior Molvin (M.B.A)(R.T)(R)(C.T.)
Stanford Radiology CT Protocol and Educational Development
Stanford Health Care
lmolvin@stanfordhealthcare.org
8

7
Preface:
• Radiopaque Iodinated Contrast Media is widely used in CT and
Angiography.
• My Background is in CT the main focus will be contrast
administration in CT
• Last Fiscal Year 55% of our CT scans were performed with IV
Contrast.
8
Objectives:
•CT Contrast Media
 What is it?
•CT System
Fundamentals
 How they work
•Contrast Agents
 Positive and Negative
•Administering
Contrast Agents
 Bolus injections
 Power injections
 Packaging
•Storing Contrast
Agents
 Warmers
 Viscosity
•Non Contrast Drugs
 How to Store
 Who Administers them
•Contraindications to
Iodinated contrast
media
 Screening
•Contrast Utilization
 Waste reduction
9
What is an IV Iodinated Contrast
Media
•Extracellular fluid marker
•Non-Ionic low osmolality
•Half Life ~ two hours with normal renal
function
•No significant metabolism of contrast media
takes place in the body
•Excretion through the kidneys
•Increase in X-ray absorption of Iodine is
related to blood flow.
9

10
X-Ray Systems:
A medical X-ray system is used to
measure density
•The CT system removes density superimposition to
generate 2,3, and 4 dimensional imaging.
Standard X-Ray With
Densities
Superimposed
11
The Density Measured is Relative to Water
(Hounsfield Scale HU)
Air is Black
Bone is White
Soft Tissue is
Grey
Contrast agents
are used to
augment the
grey scale
12
Types of Contrast Agents in CT
R.T.’s administer in California but state laws vary…
•Positive Agents
>=200 HU (Iodine,
Barium)
•Negative Agents
Density <=0 HU
(Water)
10

13
Methods of CM Administration in CT
R.T.’s administer in California but state laws vary…
•Contrast Delivery
Routes:
 IV (Indirect)
 Iodine
 Oral/Rectal
 Barium
 Iodine
 Water
 Carbon dioxide
 Inspiratory
 Xenon Gas
(Not found commonly in
clinical practice)
14
Iodinated Intravenous Contrast Media
•CM is Excreted by the
Kidneys
•Require Adequate
Renal function:
 eGFR >45
 Creatinine of 0.6-
1.1ml/dl Woman 0.6-
1.3 Men
 BUN no longer used as
primary measure of
renal function
Prophylactic TX- Pre-hydration
15
Poor Renal Function/Diabetes
Switch from 370- 300
Reducing Iodine load
Metformin Screening
11

16
Drug Interactions:
Iodinated Contrast Media and Metformin
•In the rare circumstance of contrast induced
renal failure:
•Metformin Accumulation in Kidneys can occur
 Causes Lactic acidosis
•Patients taking Metformin are advised to
discontinue taking it for 48 hours post
contrast administration and consult their
primary care provider regarding resuming
medication.
 Some physicians will request Creatinine and eGFR
screening prior to resumption of medication
 Several drugs contain *Metformin
PMID: 9640281 [PubMed - indexed for MEDLINE]
17
IV Contrast is Routinely used in 55% of CT
The Contrast Warmer
Warms CM to Body Temperature
The Power Injector
Precise injection Control
18
CT Syringe (Power Injection)
CT Syringe
200ml Capacity
compared to standard
10ml Saline syringe
Saline Sold
Separately
12

19
Loading a Syringe
Connect the straw to the
Syringe
Fill the Syringe with
Vacuum Pressure
20
Loading a Syringe
Attach IV Tubing
Connection and remove
air (Priming)
Tilt syringe down during
use.
21
Contrast Media is Denser than Bone
and has a High Viscosity
13

22
Improper Injection Technique Without
Warming the CM Can Damage the Local
Tissues
Contrast Extravasation
• Pain
• Swelling
• Compartment Syndrome
• Necrosis
Barrett, B. P. (2006). Clinical Practice. Preventing Neuropathy Induced by Contrast Medium. N. Engl. J. Med, 354(4):379–86.
doi: 10.1056/NEJMMcp050801.PMID16436769.
23
Power injections require knowledge,
IV assessment skills, and safety checks and balances.
PSI at Injector Interdepartmental
Communications
PSI of a Car Tire
24
Contraindications for Contrast Media
•Reduced Renal Function
 eGFR <30ml/min/1.73m2 (MDRD) or Creatinine >1.5ml/dl
•Allergy to Iodinated Contrast Media
 Patients who have had minor reactions such as
hives and/or hay fever may still receive contrast
 Administer preventative corticosteroid and anti-histamine
therapy.
– 50mG PO Prednisone 13 hours prior
– 50mG PO Prednisone 7 hours prior
– 50mG PO Prednisone 1hour prior + 50 mG Benadryl
 Anaphylactic allergies to contrast media are true
contraindication
14

25
Additional Screening For Contrast Media
•Diabetes
•Renal Function
•History of renal failure/transplant
•Previous allergies to iodine (Not Shellfish)
•Asthma
•Heart Disease
•Sickle cell anemia
•Pheochromocytoma
•Multiple Myeloma
26
Additional Non Contrast Medications
Administered by RN or M.D.
•Beta Blockers
 Reduce Heart Rate
 Heart Motion
Suppression
 Reduced Exposure
Settings
•Nitroglycerin
 Dilating small
blood vessels
•Lasix
 Stimulate Urinary
tract for
visualization
•Glucagon
 Reduce Peristalsis
(MRI)
•Allergy Medications
 Benadryl (Minor)
 Corticosteroids
 Epinephrine
27
Contrast Use in Radiology
Contrast Waste Reduction
Non Weight Based versus Weight Based
Old Injection Protocol
120ml @ 2ml/sec
or
140ml @ 4ml/sec
Weight based Protocol
300, 350, 370 Conversions
Single use contrast
(Optimized Image Quality)
Successful waste reduction ~6%
15

28
Multi-Pack
Residual Waste
Weight Based Single Versus Multi-Pack
Single
*Multi-Pack decreased waste and enhanced workflow ,
New Products on Market that meet Joint Commission Standards
29
Potential Future of Pharmacy Radiology
Interaction in Contrast Dosing
•There is a clear benefit in waste reduction if
healthcare organizations can successfully
integrate the multipack safely-
 Economies of Scale (Bulk Packaging)
 Workflow Enhancements
 Missing Radiologic Knowledge base in the pharmacy
from a distribution perspective.
 Two Key elements to contrast administration
30
First Key Element:
Optimizing Injections Based on Patient Weight (BSA)
250 lb Patient 128 lb Patient
16

31
Second Key Element:
Visualization of Arteries Capillaries and Veins
Injection Volumes & Rates:
Arteries:
Average Catheter Size:18G/20G
CM Volume::~1ml 370/Kg
Iodine Load: ~0.37 g/Kg
Flow Rate:~5ml/Second
Example 75 kG Patient: 75ml@ 5ml/Sec
Capillaries (Body Organ Imaging):
Catheter Size: 20G/22G
CM Volume:~1.5ml 370/Kg
Iodine Load: ~0.55 g/kG
Veins:
Catheter Size:18G/20G
CM Volume: ~2ml 370/Kg
Iodine Load: ~074 g/kG
Hemodilution
32
Conclusion
• CT Contrast Media
• CT System Fundamentals
• Contrast Agents
• Administering Contrast
Agents
• Storing Contrast Agents
• Non Contrast Drugs
• Contraindications to
Iodinated contrast media
• Contrast Utilization
33
Thank You
Lior Molvin (M.B.A)(R.T)(R)(C.T.)
Stanford Radiology CT Protocol and Educational Development
Stanford Health Care
lmolvin@stanfordhealthcare.org
17

Medication Safety Issues and
Recommended Strategies
Matthew P. Fricker MS RPh, FASHP
Program Director
Institute for Safe Medication Practices
34
Objectives for Presentation
• Identify system-based causes of medication
errors associated with the use of medications
and contrast agents in radiology
• Provide / prioritize strategies to prevent harm
and improve medication safety in radiology
35
Who is prescribing, preparing, and
administering medications?
36
18

Pharmacy Oversight
• Radiology (and other procedural areas)
‒ Commonly have minimal pharmacy oversight
‒ Limited visibility - not on pharmacy radar screen
‒ Often none or weak relationship between pharmacy
and radiology managers and staff
37
• Provide pharmacy oversight
‒ Establish relationships
‒ Learn medication use/needs
‒ Assign a pharmacy liaison to each area
‒ Regular “walkrounds” (more than to check stock
medications)
‒ Evaluate the need for ADCs to store medications and
if feasible have pharmacy review orders for
medications before they are obtained
38
Medication Errors in Radiology
Event Type Total % of Total Reports (N=985)
Wrong drug 141 14.3%
Dose Omission 133 13.5%
Wrong dose/overdosage 105 10.7%
Wrong rate (IV) 61 6.2%
Documented allergy 50 5.1%
Other 125 12.7%
39
PSA. Medication Errors Occurring in the Radiologic Services Department. June 2009. 6 (2). 46-50.
19

Radiology Errors Reported to
PA Patient Safety Authority
• 11% of all reports showed breakdowns with the use of
infusion pumps and the handling of IV lines:
‒ Misprogrammed infusion pumps
‒ Infusions that were stopped but not restarted
‒ Tubing misconnections
‒ Wrong-patient errors
40
Multi-nodal Error Potential
• Errors occur in all nodes*
‒ Prescribing
‒ Transcribing
‒ Dispensing
‒ Administration
‒ Monitoring
*most errors occur in prescribing or administration nodes
41
Communication
4
2
20

Recommended Strategies (general)
• Patient Information
‒ Ensure that essential elements of patient information
are readily accessible to all practitioners providing
care for the patient
 diagnosis / comorbidities
allergy information (including reaction)
 actual patient weight (kg not lbs)
 renal function
43
Recommended Strategies (general)
• Communication
‒ Handoffs -> share critical information when patient
transported from care unit to radiology (and back)
 critical drugs infusing (dual chamber pumps?)
 condition of patient
 what to do “if”…..
‒ Who is handing off the patient?
44
Events Related to Prescribing
• Patient information
‒ Failure to consider essential patient formation
‒ Failure to adjust doses for decreased renal function
• Communication
‒ Frequent use of verbal orders
‒ Incomplete orders / Unapproved protocols
• Oversedation requiring the use of reversal agents
45
21

Recommended Strategies (prescribing)
• Ensure that all verbal orders are repeated back to
prescriber
• Clarify all orders that are ambiguous, missing key
information or do not follow approved protocols
• Ensure that key patient information is readily accessible
and used
46
Events Related to Dispensing
• Radiology technician
‒ Retrieves wrong contrast agent from inventory
‒ Dispenses wrong product to patient
• Pharmacy
‒ Errors when restocking automated dispensing cabinets (ADCs)
‒ Expired medications in ADCs
‒ Frequency of use not periodically reviewed
‒ Excess inventory
47
Recommended Strategies (dispensing)
• Ensure all storage locations are labeled properly
• Segregate look alike products in radiology inventory
• Use meaningful auxiliary warning labels
• Regular discussions between department staff and
pharmacy to review items in ADC inventory
48
22

Meaningful
49
Events Related to Administration
• Patient Identification
‒ No identification bands (outpatient?)
‒ Failure to properly identify the patient
 not using two identifiers
 stating versus asking
‒ Not using barcode medication verification system
50
• Patient on heparin infusion at 1,000 units/hour
transported to radiology for an MRI. Nurse in radiology
discontinued the use of the pump and regulated the
heparin infusion with a manual flow device
Result:
‒ Nurse inadvertently altered the heparin infusion rate
8,000 units/hr were administered
51
MedMarx database, access June 2011
23

• To position patient, IV tubing was removed from pumps
and inadvertently returned to the wrong pump
Result:
‒ Fentanyl infusing at 125 mL/hour; ordered at 2.5 mL
hour (received 75 mcg before discovery)
‒ Large volume IV infusing at 2.5 mL/hour; ordered at
125mL/hour
52
• Radiology technician used DOBUTamine infusion line to
flush contrast media through IV tubing and catheter
• Pediatric patient in MRI suite was given 2 mL of
fentaNYL 50 mcg/mL instead of 2 mL of 1 mcg/mL
Results: Imagine
53
• “Patient presented to ED with chest pain
pain score stated as 10/10
‒ Sent to cardiac catheterization lab
‒ Received a bolus of Angiomax based on a weight
documented in ED of 73 kg
‒ Actual weight was 112 kg”
54
24

Recommended Strategies (administration)
• Ensure safe hand-off from patient care unit to
radiologic staff
‒ Communicate that infusion pumps should not be turned off
and lines should not be switched or removed from pumps
‒ Label IV contrast infusion line
‒ Check compatibility before flushing IV lines
‒ Need to call before drug infusion bag is empty
55
Drug Labeling, Storage and Standardization
• Labeling issues
‒ Inconsistent use of labels or failure to record Beyond
Use Date (BUD) on labels
‒ Technicians dispense oral contrast in unlabeled cup
 palatable drink used as vehicle
 cups not labeled with patient name, date, name of
contrast
56
Drug Labeling, Storage and Standardization
• Poor storage of drugs and contrast
‒ Often multiple drugs stored in one bin
‒ Different contrast agents not sufficiently
segregated from one another
‒ Contrast stored in warmers without a modified
BUD to reflect modified storage conditions
57
25

Drug Storage and Standardization
• Drug kits
‒ Multiple varieties and titles
 emergency kit
 hypersensitivity kit
 Transport kit
‒ Many created spontaneously by department
‒ Pharmacy may not be aware of kit / contents
‒ Contain excessive types and quantities of drugs
58
(storage and standardization)
• Ensure that all containers are labeled properly
• Record BUD on all labels
‒ Apply modified BUD for contrast placed in warmers
• Use single dose and multiple dose vials correctly
• Store drugs safely, effective segregation of different
products with proper labeling
• Limit and manage emergency kits
59
Sterile Compounding in Radiology
26

• Avoid sterile compounding unless emergent
‒ Discuss needs for compounded products and
determine if products can be prepared by pharmacy
• Ensure that all admixture instructions are well written
and vetted by pharmacy prior to use
61
Key Medication Safety Concerns
• Environment
‒ Lighting
• Staff knowledge/competency
‒ Not all areas use licensed staff to prepare and
administer medications
• Focused care/invasive procedures
‒ May not focus on medications/infusions not
associated with the exam or procedure
62
Recommendations
• Invite department managers to Patient Safety or
Medication Safety Committee meeting to voice needs /
concerns
• Use procedural “time outs”
• Standardize handoffs
• Consider RN/certified staff in Radiology and other high
volume departments
• Regularly perform a risk assessment
63
27

Perform a Risk Assessment
• Does radiology…
‒ Obtain medications, fluids or contrast agents from
outside vendors, hospital purchasing
‒ Require the same medication administration
competencies and policies employed in other
departments
‒ Track patient outcomes post-procedure
64
Perform a Risk Assessment
• Does radiology…
• Participate in hospital wide medication safety
initiatives
• Report errors/near misses
• Debrief after an event
• Request assistance from medication safety
committee to assist with analysis of event
65
Risk Reduction Strategies
• Examine the medication use process in radiology areas
• Patient care units transferring patients to radiology can
proactively address a plan for management of patient’s
infusion therapy while in radiology
• Some organizations employ nurses dedicated to
radiology services
66
28

Risk Reduction Strategies
• Adequate supervision by physician or nurse where
technicians are administering contrast media or other
medications
• Include radiology staff when evaluating or validating
competencies for medication administration
• Consider recent patient information before ordering,
dispensing or administering medication
67
Centers for Medicare & Medicaid
Services (CMS) and
The Joint Commission Requirements
Medication Safety Specialist
Institute for Safe Medication Practices
68
Top TJC Medication Standards Scored
Non-Compliant
• MM.03.01.01 Medication Storage 33%
• MM.04.01.01 Medication Orders 23%
• MM.05.01.01 Pharmacist Review 15%
• NPSG.03.04.01 Labeling in Procedures 12%
• MM.01.01.03 High Alert Medications 6%
• MM.05.01.09 Medication Labeling 6%
• NPSG.03.06.01 Medication Reconciliation 5%
• MM.05.01.07 Medication Preparation 5%
From TJC presentation
ASHP Summer Meeting, June 2014
69
29

MM.03.01.01
Medication Storage
• Medication security
• EP 3 - Stores all medications in a secure area
• EP 6 - Prevents unauthorized individuals from
obtaining medications
• Issues:
• Medication carts (code carts) not in view of staff
• Medication storage unlocked after hours
• Medications left out unsecure on counters
§482.25(b)(2)(iii)
§482.25(b)(2)(i-ii)
70
Medication Storage Issues
• EP 7 - Stored medications and components used in their
preparation are labeled with contents, expiration date,
and any applicable warnings
• Issue: No or wrong expiration date on products
• If not labeled with an expiration date by manufacturer, then
one must be assigned
• Once opened or stored in different conditions (e.g., warmer)
must have a revised beyond use date - per package insert
§482.25(b)(3)
71
Beyond Use Date
• The Joint Commission requires organizations to re-
label all drugs with a “beyond use date” once the
original manufacturer’s container is opened
• Includes IV’s stored after the overwrap is removed and
contrast in warmers
• Date must be the last date that the product is to be used –
cannot be the date opened – see FAQ
• If manufacturer specifies a beyond use date in the
package insert, must use
• Multi-dose vials must have a beyond use date not to
exceed 28 days from date opened.
• Issue: Non-contrast medications in Nuclear Medicine,
Cardiac Stress Lab, Interventional Radiology
72
30

Medication Storage
• EP 2 - Stores medications according to the
manufacturers’ recommendations or, in the absence of
such recommendations, according to a pharmacist’s
instructions
• EP 8 - Removes all expired, damaged, and/or
contaminated medications and stores them separately
from medications available for administration
• EP 18 - Periodically inspects all medication storage
areas
§482.25(b)(3)
§482.25(b)(3)
§482.25(a)
73
Medication Storage
• Issues:
• Expired drugs stored in areas for patient use
• Products stored under conditions not allowed in
package insert
• Cannot store contrast in warmer if manufacturer does not
specify it can in package insert (e.g. if closure entered,
syringes), or other document from manufacturer
• Cannot store at room temperature if manufacturer specifies it
must be refrigerated
74
The Bulk Contrast Vial Issue
Pharmacy Bulk Package (PBP)
vs.
Single Dose Vials (SDV)
75
See ISMP Medication Safety Alert!, September 20, 2012
31

Pharmacy Bulk Package
• NOT a multi-dose vial – no preservative
• Approved uses:
• Pharmacy to break down into single dose syringes in
a ISO 5 environment (laminar flow hood)
• Large volume single dose vial (1 patient/1 case)
• Special multi-dose contrast injectors in angiography
• Bracco ACIST CVi® and MedRad AVANTA®
• NOT for multi-patient use with regular contrast
injectors or multiple transfers outside of an ISO 5
environment
76
And the package insert says…
• Transfer should be performed in a suitable ISO 5 work
area, such as a laminar flow hood, utilizing aseptic
technique.
• The container closure may be penetrated only one
time, utilizing a suitable transfer device.
• Once punctured, the PBP should not be removed from
the aseptic work area during the entire period of use.
• A maximum use time of 8- 10 hours from initial closure
entry to complete fluid transfer, depending on product.
77
Pharmacy Bulk Package
• FDA interpretation (10/31/2011)–
• “An aseptic area is one that meets the following
criteria:
• Engineering controls such as HEPA-filtered laminar air flow
that meets the standards for ISO Class 5
• Appropriate cleaning and disinfecting procedures
• Periodic microbiological monitoring of the area”
• “We do not regard PBP’s as appropriate for use in the
CT suite unless the suite meets these specific criteria”
• Sterile tubing does not constitute an aseptic area
78
32

Imaging Bulk Package - History
• 2011: FDA alerted to inappropriate multi-patient use
of PBP in CT suites outside of an aseptic area
• FDA determined that approved device instructions
for contrast injectors contradicted contrast package
insert
• Required manufacturers to prove sterility of contrast
when used in their equipment.
• FDA created a new category of vial (Imaging Bulk
Package – IBP) for multiple patient use in radiology.
• First IBP approved in October 2014
79
Imaging Bulk Package
• Approved for dispensing multiple single doses of contrast for
multiple patients, using an automated contrast injection system or
contrast management system approved or cleared for use with the
IBP.
• The container closure may be penetrated only one time with a
suitable sterile component of the approved automated contrast
injection system or contrast management system using aseptic
technique.
• Once punctured, the IBP should not be removed from the work
area and the bottle should be maintained in an inverted position
such that contents are in continuous contact with the dispensing
set.
• A maximum use time of 8-10 hours from initial closure entry to
complete fluid transfer.
80
Current Status
• FDA
• Created new container - Imaging Bulk Package
• Requiring equipment manufacturers to prove sterility w/ IBP
• CMS
• Drugs are used within the pharmaceutical parameters approved by
the FDA and manufacturer’s recommendation
• Joint Commission
• Not surveying use of bulk package in CT, provided risk assessed
• Surveying: beyond use dating/timing, use in warmers.
• Legal risk of lawsuit
81
33

CDC Safe Injection Practices
• Required adherence to CDC Safe Injection Practices
guidelines
• IC.01.05.01, EP 1 Must incorporate CDC Safe
Injection Guidelines in policies and procedures
• IC.02.01.01, EP 2 Must follow CDC Safe Injection
Guidelines in practice
• Joint Commission Perspectives - October 2010
• For CDC guidelines see:
• http://www.cdc.gov/injectionsafety/unsafePractices.html
§482.23(c)
82
CDC Safe Injection Practices
• Examples from CDC Guidelines:
• “Do not administer medications from single-dose vials
or ampules to multiple patients”
• propofol, contrast
• “Do not use bags or bottles of IV solution as a
common source of supply for multiple patients”
• Interventional Radiology (IR), Nuclear Medicine
83
Report – MMWR
July 13, 2012
• When: April 2012 - Arizona
• Who: Three patients who received pain remediation and
contrast injections
• Breaches: Use of single-dose/single-use vials of contrast
media and saline solution for multiple patients and failure to
wear facemasks during injection procedures
• Patient Impact: Three patients admitted to the hospital for
severe infections including mediastinitis, bacterial meningitis,
epidural abscess, and sepsis. A fourth patient who received
contrast from the same vial was found deceased at home.
Invasive MRSA infection could not be ruled out.
84
34

MM 05.01.01
Pharmacist Review of Orders
• EP 1 - Before dispensing or removing medications
from floor stock or from an automated dispensing
machine, a pharmacist reviews all medication orders
unless:
• a LIP controls the ordering, preparation, and
administration of the medication
• LIP must be present at the patient’s bedside during
administration of the drug
• when a delay would harm the patient in an urgent
situation (including sudden changes in a patient’s
clinical status)
• First dose only
§482.25(b)
85
MM 05.01.01
• Footnote:
• Radiology: Pharmacist review of contrast orders
(including radiopharmaceuticals) is exempted.
However, the hospital is expected to define, through
protocol or policy, the role of the LIP in the direct
supervision of a patient during and after IV contrast
media is administered
• See ACR guidelines for IV contrast administration
• Issue: IV contrast administered per protocol without
specifying role of MD in supervision of patient before and
during IV contrast administration in the policy or protocol
86
MM 05.01.01
• Issue: No pharmacist review when required
• Non-contrast medications in diagnostic areas for
scheduled cases when no LIP at the patient bedside
during administration of the drug
• Non-profiled ADCs for all drugs
• Cardiac Stress: DOBUTamine, Lexiscan®, adenosine
• Nuclear Medicine: furosemide, etc.
• Radiology: LORazepam, others given by RN
87
35

MM.05.01.07
Drug Preparation
• EP 1 - A pharmacist, or pharmacy staff under the
supervision of a pharmacist, compounds or admixes all
compounded sterile preparations except in urgent
situations in which a delay could harm the patient or
when the product’s stability is short
• Presence of LIP (or admixture performed by LIP) is not an
exception! Neither is being a “procedural area”.
• Issues: Heparin drips, irrigations and other IV admixtures (often
non-standard concentration)
* =direct impact EP
§482.25(b)(1)
88
MM.05.01.07
Drug Preparation
• Definition from glossary of CAMH:
• Intravenous admixture: addition of a measured
amount of drug to a 50ml or greater bag or bottle of
fluid given by any sterile route. Add-a-vial systems,
syringes and reconstitution of vials exempt
89
MM.05.01.09
Medication Labeling
• EP 1 - Medication containers are labeled whenever
medications are prepared but not immediately
administered
• TJC defines an immediately administered medication
as “one that an authorized staff member prepares or
obtains, takes directly to a patient, and administers to
that patient without any break in the process”
• This is a different definition than USP 797
• EP 4 - All medications prepared are labeled with the
expiration date when not used within 24 hours
§482.23 (c), §482.25(b)(3)
90
36

Medication Labeling
• Issues:
• Not all medications labeled after transfer to
another container
• Medication name and strength
• Expiration date, if not used the same day
• Expiration time, if it expires in less than a day.
• Patient name (if patient specific)
• Diluent, Date Prepared (if IV admixture*)
* 50ml or greater volume bag/bottle.
91
Labeling in Procedures
• NPSG 03.04.01: Label all medications and solutions on
and off the sterile field
• Issues in Interventional Radiology:
• Not all solutions labeled
• No strength on label
• Actual containers not labeled
• Not labeled immediately before or after addition of
drug to the container
• Verbal & visual check in 2 person handoff
• Not discarding medications at end of procedure
§482.23 (c), §482.25(b)(3)
92
NPSG 03.06.01
Medication Reconciliation
• EP 2: Define (in writing) the types of medication
information to be collected in non–24-hour settings and
different patient circumstances
• OP Radiology, Diagnostics
• Can say no drug information collected for oral
contrast, or only check if on metformin and similar
drugs for IV contrast
• Can say only drug name – no dose, route, etc. for ED
• Issue: Many have changed practice but not policy
93
37

Other Standard Issues
• MM.02.01.01 – Selection of medications
• EP 1-5: Formulary Process
• EP 9: Annual review process based on safety and efficacy
• EP 10-15: Drug shortage process
• Above include contrast, radiopharmaceuticals, other diagnostics
• EP 6*: Standardizes and limits the number of drug
concentrations available
• MM.03.01.03 – Emergency drugs
• EP 2*: Emergency medications and associated supplies are
readily accessible in patient care areas
• Includes diagnostic & procedural areas
• Age-specific (pediatrics)
* =direct impact EP
§482.25 (b)(9)
§482.51 (b)(3)
94
• MM.05.01.11 – Safely dispenses medications
• EP 2: Hospital dispense medications and maintain
records according to law, regulation & standards of
practice
• Issue: Dispensing practices not the same as the
pharmacy (e.g. lack of control records; labeling with
patient name, directions, warnings, etc.)
• Dispensing oral contrast (legend drug) by radiology to
outpatients to take home
§482.25 (b)
95
• MM.06.01.01 – Safely administers medications
• Defines in policy, who can administer medications
• Must include radiology/nuclear medicine technologists.
§482.23 (c)
96
38

• HR.01.06.01 - Staff are competent to perform their
responsibilities.
• EP 5: Staff competence is initially assessed and
documented as part of orientation.
• EP 6: Staff competence is assessed and
documented once every three years, or more
frequently as required by hospital policy or in
accordance with law and regulation.
• CMS specific orientation, training, and competency
requirements in IV administration
§482.23 (c)(3)
97
• NPSG 01.01.01: Uses at least two patient identifiers
when administering medications
• Issue: Done on entry to department – and not prior
to each medication or contrast administration, as
required
• RI.01.01.01 – Respects, protects and promotes
patient rights
• Issue: Not protecting patient personal
information/privacy while gathering data in waiting
room
§482.13 (c) (1)
§482.23 (c)
98
• MM.07.01.03 – Adverse drug event reporting
• EP 6: Medication administration errors, adverse drug
reactions, and medication incompatibilities as defined
by the hospital are reported to the attending physician
or clinical psychologist, immediately when possible,
and as appropriate to the organization-wide PI
program
§482.25 (b)(6)
99
39

• MM. 08.01.01 –Evaluation of the effectiveness of the
medication management system
• EP 1 - Data collected on performance of MM system
• EP 3 - Data analyzed to identify risk points
• EP 5 - Improvements identified based on data analysis,
literature, best practices
• ISMP Medication Safety Alert!
• Issue: Not including diagnostic areas in data
collection or evaluation
§482.21 (a)(2), §482.21 (e), §482.23 (c)(5)
100
Parting Suggestions
• Periodic review of all areas where medications
are used
• Be sure to address hot patient safety issues in
media
• Work with your Joint Commission Coordinator
• Don’t panic – focus on big issues not the
obscure
• Direct impact EP’s – 3 in Manual
101
Final Point
“ Safety in health care depends more on
dynamic harmony among actors than on
reaching an optimum level of excellence at
each separate organizational level.”
René Amalberti, MD, PhD
102
40

Sources of Information
• www.jointcommission.org
• FAQ for current standards
• FAQ for current NPSG
• Copy of 2009 NPSG
• Current and Past Copies of:
• Sentinel Event Alert
• Joint Commission Online
• Pre-publication Standards
Current Standards (CAMH) and Perspectives must
be obtained from hospital TJC coordinator
103
Questions
For questions about the interpretation of Joint Commission
standards, organizations (or the public) can submit their
questions by either:
• Calling the Standards Interpretation Unit at 630-792-
5900
• Submitting the question in writing by using the following
on-line form:
http://www.jointcommission.org/Standards/OnlineQuestionForm/
104
Online Evaluation and Statement of Completion
• www.ProCE.com
• Register with
username and
password
• Deadline:
Friday, January 9
105
Event Code = GJ3YJ6Event Code = GJ3YJ6
41

CCEE AACCTTIIVVIITTYY EEVVAALLUUAATTIIOONN AANNDD CCRREEDDIITT IINNSSTTRRUUCCTTIIOONNSS
1. To receive CE credit for this activity, you must complete the post-test and activity
evaluation online no later than Friday, January 9, 2015.
2. Read the CPE Monitor information below.
3. Visit www.ProCE.com/evaluation.
4. Click on the Evaluation button which is listed with the Improving Medication Safety in
the Radiology Setting - December 8, 2014 CE activity.
5. Enter the Event Code for this CE activity: GJ3YJ6 (you will need this code to access the
post-test and activity evaluation).
6. Follow the online instructions to complete the post-test and activity evaluation, and to
receive CE credit.
7. If you need assistance or have questions, please contact ProCE at 630.540.2848 or via
email at info@proce.com.
CCPPEE MMOONNIITTOORR -- FFOORR PPHHAARRMMAACCIISSTTSS AANNDD PPHHAARRMMAACCYY
TTEECCHHNNIICCIIAANNSS
CPE Monitor is a collaborative program between the National Association of Boards of
Pharmacy (NABP) and the Accreditation Council for Pharmacy Education (ACPE). This
national e-system is designed to store and authenticate data for completed CPE units for
both pharmacists and pharmacy technicians. To create a new user account at the ProCE
LMS (Learning Management System), you will need to enter your NABP e-Profile ID
and the month and day of your birthday (in MMDD format). For more information, click
the hyperlink near the top of the ProCE evaluation web page (i.e., where you see Pharmacists and Pharmacy
Techs: Click to access CPE Monitor and latest CE information).
Note: It is ProCE policy that CE requirements (i.e. post-test, if applicable for the specific CE activity, and
evaluation) be completed within 30 days of the live activity date to ensure an on-time submission to your CPE
Monitor account. ProCE uploads completed CE activities to NABP/CPE Monitor once each week, usually on
Mondays.
42

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