How to Create a Quality Assurance Program for Radiation Safety in Interventional Radiology

How to Create a Quality Assurance Program for Radiation Safety in Interventional Radiology

How to Create a Quality Assurance Program for Radiation Safety in Interventional Radiology Craig Glaiberman, MD The practice of medicine is becoming i...

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How to Create a Quality Assurance Program for Radiation Safety in Interventional Radiology Craig Glaiberman, MD The practice of medicine is becoming increasingly complex with regard to its economic and academic aspects. In a climate of increasing cutbacks and reduced reimbursements, health care providers are being held more accountable for proving that the services they render are top quality and worthy of the cost of the care provided. Furthermore, patient safety is currently in the public eye and a driving force behind the Pay for Performance initiative. Therefore, quality assurance programs and practice quality improvement systems have been developed to promote patient safety, improve current practice patterns, and help practitioners maintain their board certification. This article very briefly describes one simple example of a radiation safety quality assurance program. Tech Vasc Interventional Rad 13:194-199 © 2010 Elsevier Inc. All rights reserved. KEYWORDS radiation safety, practice quality improvement, maintenance of certification, quality assurance

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he cost of health care in the United States is astronomic, reaching nearly 17% of the gross domestic product (GDP)—a staggering 2.4 trillion dollars in 2008.1 Other industrialized countries spend only 9-11% of their GDP on health care.2 It is expected that spending in the United States will increase to $4.4 trillion by 2018, which will be 20% of the GDP.1,3 The increase in expenditure on health care has been twice that of inflation.1 You might ask why money is being discussed to introduce a quality assurance topic. The high cost of health care has been a target of legislature for many years, yet spending continues to increase. Furthermore, although the reduction of reimbursements has been a continuing battle between health care providers and health care payers, it has not made a dent in the overall cost of health care in this nation. Now a new wrinkle has been introduced, Pay for Performance. This is a fundamental change from fee for service and will reward quality and efficiency while penalizing medical errors and unnecessary costs.

Patient Safety Patient safety has been a hot topic in the medical field and on Capitol Hill for the past 10 years. In 1998, the Institutes of Department of Radiology UCDMC, University of California, Davis, Sacramento, CA. Address reprint requests to: Craig Glaiberman, MD, Department of Radiology UCDMC, University of California, Davis, 4860 Y Street, Suite 3100, Sacramento, CA 95817. E-mail: [email protected]

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Medicine report on patient safety heightened awareness of patient safety. To Err Is Human; Building a Safer Health System enlightened both the public and the government on the relative cost of medical errors.4 The Institutes of Medicine estimated that nearly 100,000 preventable deaths occurred every year. As a result, the Centers for Medicare & Medicaid Services introduced disincentives in 2008, which eliminate or reduce payments for complications resulting in injury, illness, or death. This type of initiative has led the American Board of Medical Specialties to encourage its members boards to beef up their Maintenance of Certification (MOC) programs. Staying current and maintaining certification will help to ensure that negative incentives will not be applied to those practicing with current certificates, with the added benefit of physicians maintaining competency. In fact, academic and private hospitals may begin to require that their employees remain current such that Centers for Medicare & Medicaid Services and other third-party payers will not garner professional fees.

Maintenance of Certification As part of the American Board of Radiology (ABR) MOC, a Practice Quality Initiative (PQI) project is required. This is Part 4 of a four-part process. Eventually, the ABR will require its diplomats to complete three separate PQI projects in a 10-year cycle. However, a recent ruling has stated that only one project is required for the current cycle. There are many options available for the PQI project and the topics can vary from simple hand

A quality assurance program for radiation safety in IR washing to evaluating ways to reduce radiation exposure. However, projects must be approved by the ABR to receive credit. Basic rules for acceptance require that the project be relevant to the practice, be achievable, and have objective metrics; the results must bring about quality improvement. Some subspecialty groups, such as the Society of Interventional Radiology (SIR), have created and received approval for templates for member use. Yet, if you plan to practice for the next 20 years, you will need to perform at least three more projects. So, the next logical step is to learn how to go about developing and utilizing a quality assurance (QA) program.

Radiation Safety For many radiologists, this is probably a fairly easy metric to evaluate and one of the more timely missions to address. Reducing radiation dose to patients is multifaceted and a great topic for a PQI project. We will use this example to show you how to develop a sample QA program.

Overview for Developing A QA Program Rule 1. Keep It Simple It cannot be stated any more straightforward. Choose a QA subject wisely because the program should run in the background with very little effort or input on your part. Projects designed to evaluate one objective metric (radiation dose for example) will be the easiest to maintain and track. Look around your department for QA systems already in place. For example, Hi-IQ has built-in quality assurance programs that contain a wealth of information that can be mined for a PQI project. Do you record radiation dose routinely? Where do you store this information? Other options include participation in eRadPeer on the American College of Radiology (ACR) Web site. Performing a retrospective review of information already gathered is an option. For example, if you record radiation dose, do you routinely record it greater than 95% of the time? If not, modify your documentation practice, wait 6 months, and then review your data to see whether there has been a change. If 95% compliance has been achieved, wait 6 months and rereview to ensure that you are routinely recording dose greater than 95% of the time. Rule 2. Relevant The program must be relevant to your current practice. In 2007, Strife et al published a paper designed to give insight on the PQI project.5 Five general categories were offered as potential project ideas and include patient safety, accuracy of interpretation, report turnaround time, referring physician surveys, and application of the ACR practice guidelines and technical standards. A QA program directed toward these categories can help make your PQI project successful. Patient safety includes radiation dose reduction, procedural pause, site labeling, medication labeling, and hand washing. Accuracy of interpretation includes eRadPeer from the ACR, which are blind reviews performed by colleagues. Report turnaround times can be divided into emergent and routine to simplify the analysis and perform two separate projects if desired. The ACR has a survey on its Web site that can be downloaded and sent to referring physicians to obtain

195 subjective feedback on your practice. The results may offer many areas of improvement to address. Last, a more aggressive endeavor includes applying ACR standards and guidelines to your current practice. It is important to document a baseline performance before engaging in one of these categories such that improvement can be proven with subsequent data collection and analysis. Rule 3. Reliable, Recordable, Remeasurable, and Robust Choose a topic that will succeed. The metric the QA program addresses must be robust. Recording radiation dose is highly reliable because the machine documents the dose for every case. It is an objective number that can be recorded and remeasured. However, if your equipment is older, dose calculation may not be readily available to you and fluoroscopy time may be the only metric to measure. Although this is acceptable for a PQI project, note that it is a poor estimate of the actual dose of radiation you are exposing your patients to. Last, ensure that you document your data and results from analysis. The ABR will be randomly auditing its diplomats to ensure that Part 4 of MOC is being completed. One of the simplest ways to document radiation dose data is to dictate them into your reports. Keeping a logbook or an electronic spreadsheet will also help for data collection, processing, and submittal, should the ABR request it of you.

Creating a Simple QA Process for Radiation Dose Recording METRIC: Radiation Dose, Are You Recording It? Step 1. Society-Based or My Own Template? Where to start? Going with a society-sponsored or ABR-approved template will guarantee acceptance of your project by the ABR. However, if you follow the guidelines set forth in the Strife et al article and on the ABR Web site, and you choose your metrics appropriately, you should be able to get credit for individual projects. One of the current debates includes who will be responsible for approving the templates: the ABR? Or societies, such as the SIR? The SIR Subcommittee on Part 4 of MOC can help get individual templates approved by the ABR and posted on the SIR Web site for other members to use. Your ideas are welcome and can be submitted directly to the subcommittee at [email protected]. Step 2. Retrospective or Prospective Analysis? A simple retrospective analysis is the best place to get started. To execute a retrospective study, simply audit cases previously performed in your suite. This audit can be from the RIS, Hi-IQ, or other database used to record radiation dose or time. A prospective study will require some planning; a baseline evaluation of current practice habits, a predesigned method to improve the factors affecting the metric being studied, and repeat data collection with analysis. These are all parts of prospective investigation that should be addressed. A full discussion of this topic is beyond the scope of this introductory manuscript. However, a set of instructions and refer-

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196 ences are included on the SIR Web site where the templates are stored. Some specialty-based projects are being developed on a national level to create repositories of data. For example, a computed tomography dose registry being developed by the ACR does exactly that.6

Step 3. Which Procedure Type and How Many? Keep it simple. Choose a procedure that is standardized with little variation of technique. For example, port placement is a fairly routine intervention with rare exception. The procedure volume should be sufficient such that enough data can

Figure 1 Retrospective radiation dose recording template.

A quality assurance program for radiation safety in IR Table 1 Kerma-Area-Product Conversion Table to Standardize Radiation Dose Units Used

To Convert to Gycm2

dGy ⴛ cGy ⴛ cm2 mGy ⴛ cm2 ␮Gy ⴛ m2

Divide by 10 Divide by 100 Divide by 1000 Divide by 100

cm2

be generated to produce reliable results over 6 months. Procedures that are complex may produce radiation doses too diverse to see improvement after 6 months. For example, difficult anatomy, anatomic variation, and complications will increase radiation doses and raise the mean. Although a large number of cases can be performed to account for statistical variations, remember that you will be under the gun to complete three PQI projects in a 10-year time frame. You should document any issues or complications related to “outlier cases” justifying radiation doses that exceed a couple of standard deviations above the mean. This may help when analyzing the results to develop ways to improve your current practice and justify a lower mean dose when comparing with previous results. Although there has been no predetermined number of cases required for evaluation, 50 have been arbitrarily allocated to the SIR retrospective review. Step 4. How Will You Record Your Data? The option of relying upon existing databases, such as Hi-IQ or a RIS, does exist and if reports can be generated from these types of programs, then a separate database creation may be unnecessary. Remember that an audit by the ABR may require you to submit your results. Electronic spreadsheets can be printed and logbooks can be copied. Ensure you back up and save your data. The ABR approved a retrospective template created by the SIR, which provides space for an audit of 50 cases (Fig. 1). This template can be directly downloaded and used as an Excel spreadsheet. Instructions on how to use the template are included on the Web site at http://www.sirweb. org under the MOC link on the homepage. Step 5. Will It Be a Group Effort? If you are involved in a group practice, all radiologists in the group can participate in a single project. However, it is important to keep track of individual results because the ABR audits individual diplomats, not groups. Therefore, if there are three of you in a group practice and you wish to do a retrospective review of 50 cases, ensure you review 50 cases for each individual. Step 6. The Plan of Action: Use the Template and Record Your Baseline Data Locate where you record radiation dose or time. If you currently do not record these, the simplest way to document them is by dictating either or both into your reports. You can use the template (Fig. 1) as well. Keep track of the patient identification (medical record number), operator, and room used. Next, learn your equipment and where the radiation dose or time is displayed. As stated before, every machine is different and those older than 2003 may not display time only and not the dose. Learn your dose metric and standardize the units should they

197 vary from one suite to another. Table 1 is a quick and easy way to convert to an appropriate unit (Gycm2) for all of your machines if the metric is Kerma-area-product or dose-area-product. For ease, dose-area-product and Kerma-area-product are essentially the same. In 2004, Miller et al published a quality improvement guideline in the JVIR that nicely summarizes dose recording in the medical record.7 Step 7. Wait 6 Months after Collecting the Baseline Data, Rerecord, and Analyze Now that you have recorded 50 cases retrospectively, evaluate the data to see whether you have recorded dose or fluoroscopy time at least 95% of the time. If you have, wait at least 6 months to reevaluate another 50 cases. The whole goal is to have two successive retrospective reviews that achieve at least 95% compliance for dose recording (Fig. 2). Practice improvement can be demonstrated by maintaining or subsequently achieving 95% compliance in dose recording. Congratulations, you have completed a PQI project for radiation dose recording.

Radiation Dose Reduction, Prospective Analysis METRIC: What Are You Doing (or Not Doing) to Reduce Dose? To keep this article simple, description of a prospective PQI project for radiation dose reduction is not thoroughly discussed here. Entire manuscripts have been dedicated to ways in which radiation dose can be reduced. A sample questionnaire that has been approved for PQI use by the ABR exists on the SIR Web site under the MOC section (Fig. 3). Instructions for use of this questionnaire and the prospective PQI template that accompanies it are available to SIR members. In a nutshell, the prospective analysis of 30 cases is designed to help you find ways in which to reduce radiation dose during a specific procedure. A simple, standardized procedure, such as central venous access, is recommended. Evaluate the plan to reduce radiation dose, perform 30 pro-

Are you recording dose? QA/RIS/Hi-IQ/dictation No

Yes Review 50 cases record dose or fluoro time

Wait 6+ months

Create a method to record dose (simple DB)

Wait 6+ months

Review 50 cases record dose or fluoro time

Goal > 95% compliance 2 consecutive reviews

Figure 2 Retrospective radiation dose recording flow chart. (Color version of figure is available online.)

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Figure 3 Prospective radiation dose reduction plan and questionnaire.

cedures, and review your performance of each procedure. Answer the questions in the baseline survey and compute your mean dose. Adjust your practice to improve your technique and reevaluate your performance of another 30 procedures. Hopefully, your overall dose will remain low or demonstrate a satisfactory improvement by reducing the mean dose. Dose registries will eventually allow one to compare personal results with a national mean.

Conclusions Many different methods to create and maintain quality assurance programs exist. In this age of ever-increasing requirements, the time to practice medicine is becoming tighter. Therefore, streamlining QA and educational processes is vital. The methods described in this manuscript are simply one

way to help you get started and become compliant with Part 4 of the ABR MOC process. More information can be found on the SIR MOC link at http://www.sirweb.org and the ABR Web site, http://www.theabr.org.

References 1. Centers for Medicare and Medicaid Services: National health expenditures 2008-20018. Available at: http://www.cms.hhs.gov/NationalHealth ExpendData/downloads/proj2008.pdf. Accessed February, 2009 2. Organization for Economic Cooperation and Development (OECD): How does the United States Compare OECD Health Data? Available at: http://www.oecd.org/dataoecd/46/2/38980580.pdf. Accessed June, 2009 3. Bush G, Carter J, Ray RD, et al: Building a better health care system: specification for reform. Ontario, National Coalition. Health Care. Available at: http://www.nchc.org/materials/studies/index.shtml. Accessed August, 2009 4. Kohn LT, Corrigan JM, Donaldson MS: To err is human: Building a safer health system, Institute of Medicine. Washington, DC, National Academies Press, 2009

A quality assurance program for radiation safety in IR 5. Strife JL, Kun LE, Becker GJ, et al: The American Board of Radiology perspective on maintenance of certification. Part IV. Pract Qual Improv Diagn Radiol AJR 188:1-4, 2007 6. ACR: Response to NEJM article on CT radiation. ACR Dose Registry. Available at: http://www.acr.org/MainMenuCategories/media_room/

199 FeaturedCategories/PressReleases/Archive/ACRRespondstoNEJM ArticleonRadiationRiskAssociatedWithCTScans. aspx 7. Miller DL, Balter S, Wagner LK, et al: Quality improvement guidelines for recording patient radiation dose in the medical Record. J Vasc Interv Radiol 15:423-429, 2004