Journal of the American College of Radiology
Volume 7, Issue 2 , Pages 120-124, February 2010

Quantifying Radiation Safety and Quality in Medical Imaging, Part 4: The Medical Imaging Agent Scorecard

  • Bruce I. Reiner, MD

      Affiliations

    • Corresponding Author InformationCorresponding author and reprints: Bruce I. Reiner, MD, Baltimore VA Medical Center, Department of Diagnostic Imaging, 22 N Greene Street, Baltimore, MD 21201

Department of Diagnostic Imaging, Baltimore VA Medical Center, Baltimore, Maryland

Article Outline

The Institute of Medicine has determined that adverse drug events (ADEs) are the number one cause of medical errors in the United States and that additional efforts are required to improve patient safety. Medical imaging plays an important role in ADEs, most commonly related to the administration of imaging contrast agents. For medical imaging providers to assume a proactive role in patient safety, the creation of objective, data-driven quality metrics is advocated, which analyze all steps in the drug delivery chain, including procurement, prescription, dispersal, administration, monitoring, and management. These metrics would lead to the creation of a quality scorecard, developed to create objective accountability measures for all actors involved in this chain of events, including pharmacists, radiologists, clinicians, physicists, technologists, administrators, nurses, vendors, and patients. The ultimate goal of such an endeavor is to improve patient safety through the reduction of ADEs and the creation and refinement of data-driven best-practice guidelines.

Key Words: Quality, medical imaging, contrast agents, adverse drug events

 

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Introduction 

Medical imaging agents are defined as compounds, drugs, and biologic agents used in conjunction with imaging modalities to allow the improved conspicuity of specific pathologies or anatomic regions of interest [1]. There are two general types of imaging agents: contrast agents and radiopharmaceutical agents. In addition to traditional “macroscopic” imaging agents, new “molecular” imaging agents are being developed for the burgeoning field of molecular imaging, aimed at in vivo physiologic and pathologic assessment [2].

In the current regulatory environment, imaging agents are considered drugs and are subject to US Food and Drug Administration (FDA) approval, along with the possibility of additional regulation by the Center for Biologics Evaluation and Research [3, 4]. In 2004, the Joint Commission began considering contrast agents as diagnostic medications and applied all medication-related standards to contrast agents [5]. The new Joint Commission Medication Management Standards MM.4.20, MM.4.30, and MM.4.40 have introduced new levels of quality control and accountability for the preparation and dispensing of medications. These standards apply to any hospital department in which medications, contrast agents, or radiopharmaceutical agents are prepared, mixed, or dispensed [6].

Contrast-enhanced procedures performed in radiology departments fall under the supervision of radiologists, but contrast administration outside radiology departments requires pharmacist supervision, in accordance with standard MM.4.10. Under this standard, contrast administration outside radiology departments (eg, cardiac catheterization laboratory, surgical suite) requires pharmacy evaluation to document the appropriateness of drug therapy and dosage, analyze potential drug interactions, and determine patients' allergy histories [7].

These regulations pose significant educational, medicolegal, clinical, and technical challenges to both practitioners and institutions engaging in the delivery of medical imaging agents. This article addresses the challenges posed and offers recommendations as to how imaging and information technologies can be used to improve patient outcomes relating to medical imaging agent administration.

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Defining the Challenges 

The Institute of Medicine (IOM) has estimated that at least 1.5-million adverse drug events (ADEs) occur annually in the United States, resulting in an annual cost of $3.5 billion for hospitalized patients [8]. These medication errors occur during each step of the medication process, including procurement, prescription, dispersal, administration, and monitoring.

Although most ADEs are thought of in the clinical realm of medical practice, radiology plays a significant and often understated role. In the analysis of the US Pharmacopeia's MEDMARX program of radiology-related medication errors, 12% were associated with adverse patient actions (compared with an average of 1.7% of adverse patient actions outside of radiology). Nine of the 25 most frequently reported drugs producing medication errors were contrast agents [9].

The administration of contrast agents is ubiquitous throughout medical imaging, with tens of millions of radiologic examinations using iodinated contrast media annually [10]. Conflicting data exist in the medical literature as to the exact risk for contrast-induced nephrotoxicity [11, 12, 13, 14, 15, 16]. Contrast media reactions have been reported to represent the third highest cause of hospital-acquired renal dysfunction [11]. Contrast-induced nephropathy occurs in 2% to 3% of patients undergoing percutaneous coronary intervention [12, 13] and is associated with a number of adverse complications, including bleeding, sepsis, stroke, and respiratory failure [13, 14]. A cohort study has found that patients with contrast-induced nephropathy have an inpatient mortality risk of 34%, compared with only 7% in the control group [14].

Although intravenous contrast administration for CT is commonly perceived as the primary modality and route of concern, adverse reactions to contrast can occur through other routes and modalities. Oral contrast agents pose a small risk for aspiration, which is of particular concern within the pediatric patient population [17, 18]. Recently, gadolinium-based contrast agents in MRI have been shown to have a strong association with nephrogenic systemic sclerosis, a severe, debilitating, and sometimes fatal renal disease [19, 20]. The association between nephrogenic systemic sclerosis and gadolinium-based MRI is so strong that public health agencies have sent warnings concerning its use in patients with renal failure [21].

Adverse reactions to contrast have recently extended into ultrasound, for which the FDA has placed a “black box” warning on the ultrasound contrast agents Definity (Bristol-Myers Squibb, North Billerica, Massachusetts) and Optison (GE Healthcare, Princeton, New Jersey), after their use was temporally related to 4 deaths [22, 23].

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Existing Practice 

Although a number of excellent reference publications exist related to contrast media safety and use [24], most of the day-to-day policy and procedures related to medical media administration are left to the individual discretion of each imaging provider. Modifications to these policies and procedures are largely driven by one of two events: changing policies and regulations by the Joint Commission or an adverse patient outcome. When a clinically significant ADE occurs, retrospective analysis is performed in an attempt to identify the underlying etiology (ie, root-cause analysis) and to make recommendations as to how to prevent future events from taking place. Unfortunately, this method of quality assurance (QA) is retrospective in nature and largely predicated on the magnitude of the event. An adverse event of low clinical significance (eg, minimal contrast extravasation) will often be overlooked but may be a recurring problem because of inadequate training or supervision. The ability to capture, record, and analyze all adverse events is critical to a successful QA program, regardless of the clinical magnitude and circumstances associated with an event. This is the only realistic way to make QA prospective in nature and to identify the interaction effect of multiple variables. As an example, if a particular CT technologist were to have repeated contrast extravasations, one would want to know whether this was dependent on patient body habitus, the contrast injector technology being used, and the timing of the examinations. Perhaps this particular technologist was experiencing difficulty with extremely thin patients, using a certain type of intravenous catheter, or working during specific times of the day when volume was excessively brisk and the CT schedule was running behind. To take a proactive role, a radiology administrator would want to identify the causative and contributing factors and ensure that the technologist was given remedial training and provided with assistance during peak operating hours.

This underscores another limitation of existing practice: education, training, and credentialing are often “one-time” events. Minimal effort is expended on investing in continuing education as it relates to patient safety in the absence of a clinically significant adverse event. This is largely due to existing economic constraints, along with the reality that QA is not a revenue generator. Until economic incentives are realized, it is unlikely that departments will devote significant resources to proactive and costly QA efforts.

For these same reasons, QA-supporting technologies are not a high priority for industry research and development. Technology providers tend to focus development efforts on technology that performs a reimbursable activity (eg, CT acquisition), as opposed to one that does not. The perceived value of a given technology is often judged in economic and productivity terms (eg, return on investment), not in quality or safety terms. Until economics are directly tied to quality and safety metrics, the current practice of retrospective and reactionary QA is likely to continue.

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Innovation Opportunity 

In its assessment of medication errors and patient safety, the IOM made 3 primary recommendations for improvement:

1.Encourage patients to take a more active role in their medical care.

2.Use information technology to reduce medication errors.

3.Improve the labeling and packaging of medications.

To facilitate patients' taking a more active role in their medical care, proactive communication is required between health care providers and patients, along with improved education and bidirectional accountability. It is not enough to ensure that health care providers act in accordance with best-practice guidelines; it is equally important for patients and their surrogates to assume responsibility in compliance. The only effective way to ensure that all relevant actors are following guidelines is to create a series of objective metrics, which can record, track, and analyze all aspects of the medication process (Table 1). The most realistic method to achieve such an undertaking would be to use information technology, which is one (and perhaps the most important) of the IOM mandates for improvement. Information technology provides point-of-care reference information for accessing medical data (eg, dose, potential adverse reactions, allergies), while eliminating the potential for handwriting recognition errors. Even more important is the ability for information system technologies to create an integrated structured database using extensible markup language tags to track each individual step within the medication process and integrate these data among myriad information systems currently in use, including radiology information systems, pharmacy information systems, computerized physician order entry systems, and electronic medical records.

Table 1. Steps in medical imaging agent delivery
1. Procurement4. Administration
2. Prescription5. Monitoring
3. Dispersal6. Management

The data being collected, tracked, and analyzed would take into account the individual and collective actions of all actors involved in the drug delivery process (Table 2) and create a quantitative and objective measure of quality performance. A number of outcome analyses related to medical imaging contrast administration can on turn be derived from the proposed database (Table 3). Patients would be held accountable for ensuring that they play a proactive role in ensuring their own safety, education, and compliance. Referring clinicians would be held accountable in providing the requisite medical and historical data required to make an educated and informed decision as to the appropriateness, selection, and dosage of the contrast agent or radiopharmaceutical agent to be administered. The various staff members within the imaging department (radiologists, nurses, technologists, physicists, and administrators) would all be held accountable for ensuring that patient safety standards are being followed (in accordance with best-practice standards), QA and quality control programs are being implemented, patient and staff communication and education is a priority, and all ADEs are being monitored, treated, and documented. The often forgotten vendors (of both pharmaceutical agents and equipment) are also analyzed to ensure that their products meet FDA and other regulatory standards and that their contributory role in clinical outcomes is being tracked. This provides an important service to the users of these products in making informed decisions as to product selection, on the basis of objective quality metrics and independent of salesmanship.

Table 2. Actors and responsibilities in the drug delivery process
1. Pharmacist
a. Selection and dose of agent to be administered
b. Recognition of potential drug interactions and comorbidities
c. Contraindications to administration
d. Ensuring pharmaceutical QC
2. Radiologist
a. Determination of examination appropriateness and protocol optimization
b. Selection and dose of agent to be administered
c. Contraindications to administration
d. Monitoring of drug-induced medical complications
e. Treatment and clinical management of complications
f. Documentation and communication of ADEs
3. Clinician
a. Appropriateness of examination ordering
b. Documentation of pertinent medical history (including drug allergies)
c. Communication with patient and radiologist
d. Follow-up treatment in the event of ADE
4. Medical physicist/radiation safety officer
a. Ensuring safety in the dispersal and administration of radiopharmaceutical agents
b. QC of equipment and hot laboratory
c. Documentation and reporting of adverse action
d. Compliance with regulations
e. Education and staff training
5. Nurse
a. Clinical assessment of patient
b. Documentation of contraindications
c. Drug administration
d. Monitoring of potential complications
6. Technologist
a. Protocol selection, image acquisition, and processing
b. Drug administration
c. Monitoring of potential complications
d. Communication with patient and radiologist
e. QA (including contrast optimization)
7. Vendor
a. Safety and efficacy of drugs/equipment provided
b. Communication of drug alerts
c. FDA approval and regulatory compliance
d. Education and staff training
8. Patient
a. Compliance with physician and radiologist orders
b. Timely communication with radiologist/clinician
c. Reporting of medical history, drug regimen, and allergies
d. Retrieval of past medical/imaging records
9. Administrator
a. Compliance with community and Joint Commission standards
b. Ensuring compliance with institutional/departmental policy and procedures
c. Education and staff training
d. Overseeing departmental QC and QA
e. Documentation of ADEs

ADE = adverse drug event; FDA = US Food and Drug Administration; QA = quality assurance; QC = quality control.

Table 3. Outcomes analyses in the contrast scorecard
1. Adverse reactions to administered agents (frequency, severity, and type)
2. Management of drug-induced complications
3. Appropriateness of drug selection and dosage
4. Education, training, and certification of staff
5. Documentation of contraindications and comorbidities
6. Pretreatment of high-risk patients
7. Compliance with industry and community standards
8. Safety profile of individual actors (as listed in Table 2)
9. Institutional safety profile
10. Drug safety profile
11. Vendor safety profile
12. Reporting and communication of adverse actions

The ability to make a quality-centric informed decision also extends to the service side of the equation, whereby patients and referring clinicians would have an objective means to assess safety measures among various imaging providers. A patient being referred for CT angiography of the chest would be able to review the safety profile of the department, institution, and individual staff members before selecting the service provider of choice.

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Conclusion 

The ultimate goal in such an endeavor would be to create an objective means of safety and quality analysis, while contributing to the practice of evidence-based medicine. If created in a standardized and nonproprietary manner, these quality-centric data could be pooled to perform meta-analysis, for the purposes of enhancing clinical research, establishing best-practice guidelines, improving education and training, and creating accountability measures for all involved parties. In turn, those service providers with the highest safety measures would have the potential to receive economic benefits, through increased referrals and an additional fee tied to the enhanced safety and quality measures. Such a program is not intended to be punitive in nature but is instead aimed at creating a tool for enhanced patient safety and empowerment. In the end, reducing the number and severity of ADEs is the primary goal, and the scorecard provides one option to get there.

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References 

  1. Henderson JA, Alexander BC, Smith JJ. The Food and Drug Administration and molecular imaging agents: potential challenges and opportunities. J Am Coll Radiol. 2005;2:833–840
  2. Hillman B, Neiman HL. Translating molecular imaging research into radiologic practice: summary of the proceedings of the American College of Radiology Colloquium, April 22-24, 2001. Radiology. 2002;222:19–24
  3. Food, Drug, and Cosmetic Act, Pub L No 75-717, 52 Stat 1040 (1938) (as amended 21 USC 301 et seq).
  4. US Food and Drug Administration. Biological products: general. 21 CFR 600.
  5. Morrison G, Odle TG. Safety considerations in contrast media handling and administration. https://www.asrt.org/media/pdf/educators/KM07WhtPprContrastSafetyFINAL2081307.pdfAccessed October 18, 2009
  6. E-Z-EM. Is your department still JCAHO compliant?. http://www.ezem.com/pdf/1304020_ctjcaho.pdfAccessed October 18, 2009
  7. Stevens CM. Regulatory compliance associated with contrast media. http://www.ahraonline.org/AM/Downloads/OnLineED/2005NovDec.pdfAccessed October 18, 2009
  8. Aspden P, Wolcott JA, Bootram JL. Preventing medical errors. Washington, DC: National Academies Press; 2007;
  9. Santell JP, Hicks RW, Cousins DD. MEDMARX data report: a chartbook of 2000-2004 findings from intensive care units and radiological services. Rockville, Md: MEDMARX; 2005;
  10. Katzberg RW, Haller C. Contrast-induced nephrotoxicity: clinical landscape. Kidney Int. 2006;69:53–57
  11. Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002;39:930–936
  12. Bartholomew BA, Harjai KJ, Dukkipati S, et al. Impact of nephropathy after percutaneous coronary intervention and a method for risk stratification. Am J Cardiol. 2004;93:1515–1519
  13. Rihal CS, Textor SC, Grill DE, et al. Incidence and prognostic importance of ARF after percutaneous coronary intervention. Circulation. 2002;105:2259–2264
  14. Levy EM, Viscoli CM, Horwitz RI. The effect of acute renal failure on mortality: a cohort analysis. JAMA. 1996;275:1489–1494
  15. Newhouse JH, Kho D, Rao QA, Starren J. Frequency of serum creatinine changes in the absence of iodinated contrast material: implications for studies of contrast nephrotoxicity. AJR Am J Roentgenol. 2008;191:378–382
  16. Bruce RJ, Djamali A, Shinki K, et al. Background fluctuation of kidney function versus contrast-induced nephrotoxicity. AJR Am J Roentgenol. 2009;192:711–718
  17. Halsted MJ, Racadio JM, Emery KH, et al. Oral contrast agents for CT of abdominal trauma in pediatric patients: a comparison of dilute Hypaque and water. AJR Am J Roentgenol. 2004;182:1555–1559
  18. Donnelly LF, Frush DP, Frush KS. Aspirated contrast material contributing to respiratory arrest in a pediatric trauma patient. AJR Am J Roentgenol. 1998;171:471–473
  19. Perez-Rodriguez J, Lai S, Ehst BD, et al. Nephrogenic systemic fibrosis: incidence, associations, and effect of risk factor assessment: report of 33 cases. Radiology. 2009;2:371–377
  20. Penfield JG. Nephrogenic systemic fibrosis and the use of gadolinium-based contrast agents. Pediatr Nephrol. 2008;12:2121–2129
  21. Stratta P, Canavese C, Aime S. Gadolinium-enhanced MRI, renal failure, and nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy. Curr Med Chem. 2008;12:1229–1235
  22. Dolan MS, Gala SS, Dodla S, et al. Safety and efficacy of commercially available ultrasound contrast agents for rest and stress echocardiography: a multi-center experience. J Am Coll Cardiol. 2009;53:32–38
  23. Main ML, Ryan AC, Davis TE, et al. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent. Am J Cardiol. 2008;12:1742–1746
  24. American College of Radiology. Home page. http://www.acr.orgAccessed October 18, 2009

PII: S1546-1440(09)00468-2

doi:10.1016/j.jacr.2009.09.018

Journal of the American College of Radiology
Volume 7, Issue 2 , Pages 120-124, February 2010

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