Joann C. Wilcox, RN, MSN, LNC

Transcription

1 Authored by: Joann C. Wilcox, RN, MSN, LNC Published by: Creative Training Solutions, Inc. Copyright 2016 Creative Training Solutions, Inc. All rights reserved. No part of this book may be reproduced or manufactured in any form or by any means, electronic or mechanical, including photocopying, printing, recording, or by any other information and storage retrieval system without written permission from the publisher. When taking the test online one printed copy may be used for reference only. Additional copies must be purchased from the publisher. This publication is an educational activity supported by:

2 Educational activities by Creative Training Solutions are distinguished as separate from endorsement of commercial products. CE Credit Information: This course meets all criteria and has been approved by AHRA: The Association for Medical Imaging Management, for 3.5 Category A, ARRT continuing education credits. This course has been approved for 3.5 nursing contact hours by MedEd America, an approved provider of nursing continuing education by the Georgia, Washington D.C. and Florida State Boards of Nursing. Most States accept contact hours for nursing continuing education if approved by a State Board of Nursing. If you are not licensed in the State of Georgia, Florida or Washington D.C., you should check with your board of nursing to be sure that contact hours from a provider approved by the Georgia, Florida, and Washington D. C. Boards of Nursing are acceptable. Copyright 2016 Creative Training Solutions, Inc. All rights reserved. No part of this book may be reproduced or manufactured in any form or by any means, electronic or mechanical, including photocopying, printing, recording, or by any other information and storage retrieval system without written permission from the publisher. When taking the test online one printed copy may be used for reference only. Additional copies must be purchased from the publisher. The opinions expressed in this publication are not approved or endorsed by Guerbet Inc. Publisher: Kansas City, MO Creative Training Solutions has been in business since 1992 providing healthcare workers with accredited courses that meet state and national requirements for continuing education credits. CTS assist s healthcare providers in improving patient care, management training, team development, regulatory compliance and planning/implementation to improve organizational outcomes. Our capabilities and experience range from assisting individual departments in streamlining their operations and improving customer satisfaction, to organizationwide redesign initiatives directed at improving operations and increasing patient loyalty. CTS offer s a wide range of customized healthcare training programs to enhance patient care and improve organizational productivity. Onsite continuing medical education programs Trainers for medical conferences Consulting services to hospitals Self-study continuing education programs for immediate CE credits online

3 Table of Contents I. Introduction... 4 II. MRI Briefly Described... 5 III. Working to Achieve Safe Care... 6 IV. Definitions V. Risks/Injuries Accidents during an MRI VI. Development of MRI Rules, Regulations. Guidelines VII. Example of what should be Included in an MRI Policy/Procedure Manual VIII. The Next Generation IX. A Culture of Safety X. The Ethics and Economics of Safe Care XI. Examples of Safety Programs XII. What is My Obligation XIII. Keep the Patient Safe Appendix A. The Joint Commission-Sentinel Event Appendix B. Aunt Minnie.com-ECRI s Report on MRI Safety Appendix C. MRI Safety Product Copyright 2016 Creative Training Solutions, Inc. All rights reserved. No part of this book may be reproduced or manufactured in any form or by any means, electronic or mechanical, including photocopying, recording, or by any other information storage and retrieval system, without permission in writing from the publisher. The opinions expressed in this publication are not approved or endorsed by Guerbet Inc. Publisher: CREATIVE TRAINING SOLUTIONS, INC NW Whipple Lane, Kansas City, MO

4 Objectives After studying the information presented, the reader should be able to Detect the most prevalent errors that lead to serious accidents, including death. Identify some of the most predominant errors that can and do occur during an MRI. Pinpoint rules and regulations for MRI settings including the four specific zones in the MRI Suite. Recognize the most common causes of injuries. Determine the framework from which safety practices can be developed. Pinpoint MRI rules, regulations and guidelines and give examples of what should be Included. Identify established standards for safety. Understand the principles of Crew Management and how it applies to healthcare. Identify standards that guide the provision of healthcare. Pinpoint the ethics and economics of Safe Care. Provide examples of what should be Included in an MRI Policy/Procedure Manual (based on the information in the ACR Guidance Document on Safe MR Practices 2013). 2

5 About the author Joann C. Wilcox, RN, MSN, LNC is a Legal Nurse Consultant and Healthcare Educator and Consultant who has held position of Vice-President of Patient Care Services, Vice-President of Administration, Director of Clinical Risk Manager, Patient Safety Officer, Patient Privacy Officer and Joint Commission Survey Coordinator in various acute care organizations. Ms. Wilcox was also a member of the University of Phoenix On-Line faculty for both the Baccalaureate and Master s programs. The focus of the position was on medical ethics, nursing administration and related nursing and administrative topics. Ms. Wilcox has held memberships in the American Nurses Association and the American Association of Nurse Executives as well as a member of several organizations focused on the improvement of patient safety in our healthcare systems. She has provided multiple seminars at sites across the United States on issues related to patient safety, the reduction of medical errors, preparing for a Joint Commission Survey, safety in the Radiology department and the implementation of the HIPAA privacy regulations. 3

6 MRI Safety Radiology has evolved beyond mere x-rays Now essential for making many diagnoses and treatments. Progress has not been matched by the human s ability to cope with a huge amount of data generated by one MRI. I. Introduction Magnetic Resonance Imaging (MRI) is a way of obtaining very detailed images of organs and tissues throughout the body without the need for x-rays or ionizing radiation (Radiology Info, nd). While reducing the exposure to ionizing radiation is a positive aspect of the MRI, the fact that we are now dealing with an extremely powerful magnet in a world where so much is attracted to that magnet, creates the need for a safety plan that has little room for error. The focus of this booklet is to address the safety of patients and staff during the MRI procedure. This will be done by reviewing the efforts of the practitioners in the early 1900 s who worked to validate that healthcare could be standardized and to the efforts of practitioners today to significantly reduce the number of medical errors, some of which are the outcome of using equipment such as the MRI. This booklet is not a User s Manual describing what needs to be done for each step of the MRI. It is, instead, a manual that focuses on creating and maintaining a safe environment for patients undergoing an MRI and for staff who are participating in administering that procedure. As a professional radiologic technologist or technician, radiologist, registered nurse or staff member in a health care facility, you must be committed to provide the care and services you expect if and when you are on the receiving side of that care delivery. You also want assurance that your family members will receive this same level of care whether or not you are there to monitor the care being provided. 4

7 There is no question about the need for delivering safe care: but do we accept the fact that the delivery of truly safe care is the responsibility of each person in the healthcare system? *Specifically, consider the very long history describing the commitment to providing safe care: the number of people involved, the time invested in developing methods to achieve safe care, the meetings, the surveys, the time spent teaching providers of care about safe care and reducing medical errors, the time and money spent on consultants, and the continued increase in the number of medical errors (with consideration of an increase in population and technology), etc. Ask yourself these questions: 1) What is the common variable in all of the discussions, money spent, etc.? 2) What does it really take to provide safe care with a reduction in medical errors? 3) Why have we not been more successful in error reduction when considering the time and money invested in providing safe, and error-free care? II. MRI Briefly Described Magnetic Resonance Imaging (MRI) is a medical imaging procedure that uses strong magnetic fields and radio waves to produce cross-sectional images of organs and internal structures in the body (U.S. Food & Drug, ND). An MRI provides information about the structures being studied that cannot be gained by other, more routine methods of study. The MRI works on the phenomenon, discovered in the 1930 s, called nuclear magnetic resonance (NMR) in which magnetic fields and radio waves cause atoms to give off tiny radio signals. In 1970, Raymond Damadian, MD, discovered the basis for using magnetic resonance imaging as a tool for medical diagnosis. He completed construction of the first whole-body MRI scanner by 1977 (Bellis, nd). The use of the MRI developed quickly with the first equipment being available to qualified healthcare individuals in the 1980 s. In 2002, there were approximately 22,000 MRI cameras in use world-wide and more than 60 million MRI exams were performed (Bellis, nd). This technology continues to grow rapidly. MRI s are used to diagnose a medical condition and/or to monitor the effect of treatments on the part of the body being visualized. In general, MRI s are safe assuming the preparation and maintenance of the MRI Suite meets the safety 5

8 requirements: particularly as it pertains to the safe use of a powerful magnet during the procedure. The procedure does not cause pain or known tissue damage. However, the fact that it uses a strong magnetic field and radio-waves increases the risk of harmful accidents to the patient and any other person(s) involved in performing the procedure. At the same time, it is important for staff and providers to recognize that these accidents are preventable which requires all involved to demonstrate a clear understanding of what must be in place before an MRI is initiated. The outcome of many of the errors made during an MRI are often severe or deadly. This adds to the stress of those who are a part of the team providing this procedure to the patient. However, the steps to take for each and every MRI being performed are clear and are essentially the same for each and every MRI performed. As individuals who are working in this area of healthcare, knowing what needs to be done to eliminate the risk of these errors from occurring is essential. It is also essential for each and every provider who is participating in the MRI procedure to speak-up when they observe that not all steps that need to be taken to avoid the risk of an error from occurring have been taken. Consequently, it is required that all involved listen to the concern and address it before the procedure is initiated, no matter the level of provider who is speaking-up. Additional information regarding MRI accidents and the prevention of these events is provided as a part of this booklet. This discussion starts with an historical review of the steps that have been taken to reach the point in our healthcare system where safe care is expected-and provided. III. Working to Achieve Safe Care We currently have an environment in which there are well-researched approaches to healthcare. We often have multiple choices for how to treat some illnesses while still maintaining the standards of care believed to be the best we can reach at the time. We strive to provide care that leads to a higher level of health while causing no harm to that patient. However, with all of the achievements that have been made, there are more and more medical errors being made, creating questions about what we missed while working hard to reach the level of healthcare we know should be achieved. When looking at the history of the delivery of healthcare services, it is clear that the provision of safe care has been discussed and considered for decades. In many earlier discussions, it was assumed that the care provided was safe, at least as safe as 6

9 possible with the information available at the time. As care increased in complexity, it became apparent that standards of care were needed to measure the impact of the interventions. Were the intended outcomes achieved? Was the care error-free? When trying to answer questions such as these, it is often helpful to gain an understanding of how we got to where we are. History lays a foundation upon which many new and improved methods of addressing problems are defined. This new platform is then used by others as they are addressing problems that they are working to solve. Going back to 1910 should provide enough history for the consideration of how we are addressing safety in healthcare in 2016 and, more specifically for this booklet, how we provide safe care for the patient in the high-risk MRI Suite. In 1910, Ernest Codman, M.D., proposed the development of the end result system of hospital standardization. Under this system, a hospital would track every patient it treated long enough to determine whether the treatment was effective. If the treatment was not effective, the hospital would then attempt to determine why, so that similar cases could be treated successfully in the future (The Joint Commission/History, 2010). This may be the first significant step to measuring outcomes of care. This was followed in 1913 with action by the American College of Surgeons. This group made the end result system identified by Codman a stated objective of the College and, in 1918, reviewed hospital surveys finding that only 89 of 692 hospitals surveyed met the requirements of the Minimum Standard (The Joint Commission/History). The Joint Commission, founded in 1951, has as its purpose the following: The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. This was one of the first organizations to evaluate health care organizations while creating standards that needed to be followed to excel in providing safe and effective care This built upon the work of Codman and American College of Surgeons and continued to grow to the point we have reached in the healthcare system as we know it today. Joint Commission s entrance as an outside reviewer (54 years ago), initiated the collaboration with other healthcare facilities leading to the development of standards of care that all were expected to meet, improve and meet again. In 1952, the American College of Surgeons officially transferred the Hospital Standardization Program to the Joint Commission for Accreditation of Hospitals (JCAH) 7

10 (The Joint Commission/History). The JCAH started offering accreditation services to hospitals in January In 1965, the United States Congress passed the Social Security Amendments of 1965 which included the introduction of the Medicare and Medicaid programs and the standards providers needed to meet to participate in these programs. At a later time, a provision was developed stating that hospitals accredited by JCAH were "deemed" to be in compliance with the Medicare Conditions of Participation for Hospitals and, thus, were able to participate in the Medicare and Medicaid programs. This was a very important decision for healthcare since the relationship between compliance with regulations and payment for services for the Medicare and Medicaid populations was now clearly linked (The Joint Commission/History). The on-going history of The Joint Commission provides information on how quality in a facility was to be determined. In 1988, the Indicator Measurement System was introduced as the way to monitor performance in our hospitals. In 1993, the Accreditation Manual for Hospitals was reorganized around important patient care functions to shift the focus from standards that measure an organization s capability to perform to those that look at its actual performance (The Joint Commission/History). In 1999, (16 years ago) the year before the publication of the information regarding the number of medical errors that were occurring in hospitals, the Joint Commission revised its mission statement with reference to patient safety: "To continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations" (The Joint Commission/History). This began the expectation for an aggressive movement from process to outcomes as organizations struggled to find the way to determine safety and quality. This appeared to be a return to the end-result system Dr. Codman introduced in 1910 (105 years ago)! The importance of this history is that even in the very early years, organizations developed their quality review quality improvement programs based upon the defined expectations of The Joint Commission, or what was to become The Joint Commission. It was critical for organizations to demonstrate compliance with the standards and looked to The Joint Commission for education and support as each worked to get what was needed to provide safe quality care and services. The hundred year history of dedication to quality by The Joint Commission is recognized as a major reason why our healthcare system is as safe and effective as it is as we continue to do what is needed to continuously improve in these areas. However, how could a system be considered safe when the number of medical errors increased 8

11 as care and interventions continued to reach heights that were not even imagined in 1910? Although there was a growth in the expectations that the delivery of healthcare needed to meet defined standards to achieve the delivery of safe care, it became clear that information about unsafe care, care that was provided in error and care that was missed was rarely discussed anyplace within the facilities where this unsafe care was provided. There was no discussion with the affected patients or family. Transparency of care, including discussion of errors, was non-existent and this allowed the hospital and medical staff to hold on to the thought that mistakes will happen we are doing the best we can do and those who do not work in the healthcare environment would not understand errors in care. Certainly, the patient/family could do nothing to change the fact that an error occurred so it was best to not burden them with discussion of errors that may have occurred. Organizations such as the Joint Commission and state licensing agencies began to address the actions that appeared to lead to longer hospitalizations and treatments that were not anticipated at the time of admission. Overtime, efforts were being taken to reduce errors so that the anticipated outcomes of care could be reached. However, the silence expected if and when an error in care delivery occurred remained, making it close to impossible to address what happened and why it happened. Trying to determine how the error could have been avoided was close to impossible if one could not access all elements of that error. In the 1990 s, the Joint Commission increased their focus on identifying errors in care delivery which resulted in extended time in hospitals or other care facilities. The Sentinel Event Policy was established in 1996 with the goal of assuring medical errors were identified and addressed with the goal of developing actions that would be taken to avoid the error(s) from happening again. In 1998, the Joint Commission revised the Sentinel Event policy to promote self-reporting of medical errors and encourage healthcare providers to more closely examine the root causes of these events (TJC, 2014). One of the elements of silence regarding medical errors was now being eliminated as these actions were introduced. A significant event in this era of healthcare delivery occurred in 2000 with the publication of the book To Err is Human. This book was developed by the staff at the Institute of Medicine, utilizing reports from various individuals who demonstrated technical expertise in the areas being addressed (IOM, 2000). The information in this book removed the silence surrounding medical errors with the following statement: The results of the New York Study adverse events in hospitals leading to patient death 9

12 suggest the number may be as high as 98,000 each year (2000, IOM, p. 1). This quote was quickly disseminated nationwide and led to significant changes in the way medical errors were identified and analyzed culminating in the development of plans to avoid these errors from happening again. As a result of the nation-wide publication of the impact of adverse events, the cloak of secrecy was no longer available and was replaced by Joint Commission requirements that patients and family are to be advised when a medical error has been committed, that the treating physician must meet with the patient/family, and that information regarding what will be done to minimize the possibilities that this error could happen again to someone else needs to be provided. All of this information must be documented in the patient s health record. In 2014, the Joint Commission introduced a new Patient Safety Systems chapter in the 2015 standards manual. Dr. Codman can now rest in peace. The Joint Commission has continued its presence and importance since the time it was first introduced. There are many similar organizations, most of which are specific to a practice such as the American College of Radiology. These organizations generally work closely with The Joint Commission while also developing practice-specific standards for the delivery of safe and effective care. It is important for every member of a hospital staff providing care to patients to be aware of the way in which medical errors are addressed in the facility and the role each person plays in developing and implementing corrective actions in the facility. Staff should consider volunteering to be a member of the safety committee or the quality review committee, etc., as a way to learn more about error elimination or correction. The questions staff should ask are: What is the relationship between the levels of compliance with accreditation standards and the predicted/expected outcomes of care? What is the relationship between the levels of compliance with accreditation standards and the competency of the individuals who are providing the care/services? What is the relationship between the levels of compliance with accreditation and the number of medical errors that are committed on an annual basis? What is the relationship between the levels of compliance with accreditation standards and the cost of healthcare? 10

13 IV. Definitions The words used when discussing patient safety have various definitions depending on the facility and the selected approach to improvement in the provision of safe care. The following definitions are provided for use when reading this booklet. A. Quality: Quality is generally thought of as conformance to specifications but the definition of this word is broad, changing and dependent upon the context in which it is being used. Most, generally agree that quality does not exist until the care provided is identified as being safe. B. Standards: In healthcare, standards are statements concerning proper procedures and/or actions to be taken in given clinical or administrative situations (Kavaler & Spiegal, 1997). In general, standard means minimum since one cannot be successful if practicing below a standard. C. Accreditation: An evaluation process carried out by independent professionals external to the healthcare organization and its governing bodies to ensure that conditions regarding the safety, quality of care and treatment of patients are taken into account by the healthcare organization (Paccioni, Sicotte & Champagne, 2008). D. Outcomes Management: A system for assessing and identifying preferred medical or surgical interventions or non-interventions that lead to a desired clinical outcome. E. Medical Error: the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim (IOM, 2000). G. Adverse Events: an injury caused by medical management rather than by the underlying disease or condition of the patient (IOM, 2000). H. Unpreventable Adverse Event: an adverse event resulting from a complication that cannot be prevented given the current state of knowledge. I. Near Miss: an event or situation that could have resulted in an incident, injury or illness, but did not, either by chance or through timely intervention. A near miss signals a system weakness that if not corrected could lead to an actual error at some time in the future. 11

14 J. System Error: an error that is not the result of an individual s actions but the predictable outcome of a series of actions and factors that comprise a diagnostic or treatment process. K. Ferromagnetic: pertaining to substances such as iron, nickel, and cobalt that are strongly affected by magnetism and may become magnetized by exposure to a magnetic field. V. Risks/Injuries/Accidents during an MRI Identified below are some of the most prevalent errors that can and do occur during an MRI. These can be prevented, in almost all cases, when staff has full knowledge of how to prepare patients for the MRI and prepares the patient and the environment accordingly. A. Risks/Injuries Experts contend that a series of converging factors has created an environment that is ripe for MR-related accidents, heightening the need for increased vigilance in adopting MR imaging safety procedures and protocols (Gilk, 2010). Projectiles are a common cause. These occur when ferromagnetic objects are pulled toward the magnet at a high rate of speed. Burns from objects containing heat-conductive materials. Injuries from implanted devices such as a pacemaker. The MRI signals can disrupt the functioning of the pacemaker. Adverse reactions to the contrast media. Hearing injuries from enhanced sound from the MRI. Drug delivery patches when the patches contain metallic foil. Claustrophobia and anxiety. 12

15 B. Accidents in the MRI Suite Each facility providing MRI services has the information required to create and maintain safe patient care throughout the procedure. In an area as complex as that which is needed for a safe MRI, there are times when an accident might happen or an element of care can be missed. Is this acceptable when we have as much time and energy spent on providing safe care since 1991? A report in the July 31, 2001, New York Times, described an incident in which an oxygen tank flew into the head of a young patient causing a fatal injury (ECRI, 2001); A sentence in the newspaper addressing how this accident happened stated a metal oxygen tank somehow made it into the examination room (2001, p.1). The patient, a six-year old boy, was sedated and ready for the exam when it was noted his oxygen saturations level was dropping. The Anesthesiologist noted the piped in oxygen malfunctioned and called out for some oxygen. A nurse, who was not a part of the MRI staff, handed him a steel oxygen tank which, once inside the scanning room, flew out of the Anesthesiologist s arms into the head of the boy. Most are prepared to act quickly to save a patient from harm. Also, most healthcare staff does not think about every day equipment/supplies in a patient treatment room as being hazardous to their health. The move to identifying zones and indicating who/what is allowed in each zone is one remedy that was developed to prevent this kind of accident from happening if all involved followed the established rules and regulations. In 2009, an office deputy was hurt when her hand was trapped between her police-issued gun and the MRI magnet. This deputy was with her mother in the MRI suite and forgot she had the gun when she entered the suite. The magnetic force trapped he hand between the MRI and the gun (Metrasens, 2009). While she was able to free her hand, the gun remained stuck to the MRI for the 24 hours it takes to power the MR down. In 2009, did the MRI community of providers have knowledge of what would happen if one entered the MRI Suite with a metallic weapon? 13

16 An IV nurse entered the MR Suite with her metal IV cart. The magnet lifted the cart and it flew through the air. No one was injured. The IV nurse did not realize the power of the magnet (Metrasens, 2009). How did the nurse get as far as the MR suite with a metal cart without No signage? No one else around? being noticed? A patient was wheeled into the MRI Suite on a ferromagnetic gurney. He and the gurney were pinned against the MR system. In 2009, did the MRI community of providers have knowledge of what would happen if one entered the MRI Suite with a ferromagnetic gurney? A common cause of accidents are projectiles -ferromagnetic objects are pulled toward the MR imaging system at high speed and will hit anything in its way. The literature states, There is an alarming number of injuries to MR technologists and service personnel (rsna.org, 2010). Was any of this new information? Are health care providers able to make a mistake of this magnitude with no consequences to themselves? C. Reporting The literature in 2001 regarding adverse events in MRI suites indicates that the number of these events are quite small primarily because MR personnel typically adhere to safety protocols (ECRI, 2001, p.1). It was also noted that it is likely that near-misses do occur and these are never reported. One thing that all successful safety officers know is that the reporting of near-misses, in any facility, is what helps develop plans to keep the near-misses from becoming full-blown errors. Near-misses are what brings potential errors to the attention of all who can make the needed corrections before that error is committed. The year 2004 was the last year in which the FDA recorded a decline in the number of MRI accidents and the number of accidents has increased 300% since that date (Metrasense, 2009, p.1). The use of MRI s only increased 3% per year so it does not appear that an increase in numbers of tests completed is the cause of the significant increase in accidents. 14

17 Improved reporting of accidents might be considered as a reason for the dramatic increase in the number of accidents. However, increased reporting at the level that would need to be in place did not likely occur since there was no governmental or professional group working to increase awareness of reporting criteria (Metrasense, 2009, p. 2). Remember, the Joint Commission did not become involved until 2008). The FDA concluded that there was most-likely an increase in harming MRI patients but the data does not implicate any single risk factor. VI. Development of MRI Rules, Regulations and Guidelines A. Rationale for the Development of a Set of Rules, Regulations and Guidelines Mainly because of the strength of the magnet used for the Magnetic Resonance Imaging procedures, multiple guidelines, rules and regulations have been defined for all users of this equipment to follow. These rules, regulations and guidelines must be followed by technicians, technologists, radiologists, registered nurses, patients and family members. In 1991, individuals from the Society for Magnetic Resonance Imaging (SMRI), developed Policies, Guidelines, and Recommendations for MR Imaging Safety and Patient Management (Shellock & Kanel,1991). This report was the first description of regulations that needed to be followed for the safe use of the MRI. Several meetings of the American College of Radiology Blue Ribbon Panel on MR Safety met in 2001 to review the existing MR safe practices and guidelines and to issue new ones as appropriate (ACR White Paper, nd). ACR White Papers were written in 2002 and 2004 as new safety information was developed to address the growing use of the MRI. Several modifications and updates were made to the original document. The revised document is labeled ACR Magnetic Resonance Safe Practice Guidelines Combined Papers of 2002 and One can follow the continuous additions/corrections to the rules, regulations and guidelines for MRI safety as the use of MRI s grew and information learned from practice and near-misses increased. The margin for error in the MRI suite is so narrow that it takes continuous monitoring and review/implementation of safety procedures to avoid the kind of accidents that are possible with a machine with such powerful magnetism and a society with new gadgets, widgets, and magnet-drawn things every day! 15

18 B. Raising the Stakes of MRI Patient Safety 2006 (9 years ago) MRI utilization is up roughly 50% in the past four years (Gilk, 2006). MRI applications were up and magnet strengths are almost doubled. With these two facts, the risk factors for undergoing an MRI examination increased making the requirement for enforcement of the rules, regulations and guidelines essential; there is no room for error! Additionally, the growth in procedures being scheduled and performed included a significant increase in the complexity of the procedures that was not present earlier. For example, there was a growth in sedating more patients, taking biopsies from more patients, imaging the infirm in greater numbers all on magnets of greater and greater strengths (Gilk, 2006). These advances also increased the potential for an increase in patient injuries. It is believed by clinicians who are part of MRI teams that MRI injury accidents happen regularly but are not reported (Gilk, 2006). This may help make the MRI look like a safer examination than it is, and gives an artificial sense of security within the industry (2006). It is also believed by some that while there are protocols, products, and designs to mitigate MRI risks these tools are not universally applied (Gilk, 2006). Keeping up with the substantial growth in the number and uses of the MRI, may make it difficult to implement the stringent safety processes that need to be enforced when using this equipment. C. Rules and Regulations As indicated above, rules and regulations for MRI settings were published initially in These MR Safe Practice Guidelines were the standards for safe and responsible practices in clinical and research MR environments (ACR, 2007). These were reviewed and updated in May 2004 and resulted in an extensively reviewed, modified, and updated document in The document addresses all the major aspects of a safe program including the introduction of the Zoning of the MRI Suite into four specific spaces, each of which clearly listed what could be done each zone and who could enter into each zone. This 16

19 was one way to gain the needed level of control essential to reduce some of the accidents that were continuing to occur. Zone I: This region includes all areas that are freely accessible to the general public. Zone II: This area is the interface between the publicly accessible, uncontrolled Zone I and the strictly controlled Zones III and IV. Zone III: This area is the region in which free access by unscreened non-mr personnel or ferromagnetic objects or equipment can result in serious injury or death as a result of interactions between the individuals or equipment and the MR scanner s particular environment. Zone IV: This area is synonymous with the MR scanner magnet room itself, that is, the physical confines of the room within which the MR scanner is located. The division into zones, each with their own definition of what and/or who can be in a specific zone, does break a large area into spaces that can be more easily monitored while serving specific functions for the service. It is felt by the leadership that it was essential to embrace the American College of Radiology s four-zone principles to reduce injuries and to avoid state-imposed regulations for use of the MRI. D. The Joint Commission Addresses MRI Safety (2008). On January 1, 2008, the Joint Commission presented a revision of the Environment of Care Standards to include a section on medical equipment risks and, for the first time, included reviewing MRI equipment risks. Prior to this change, the Joint Commission Environment of Care Standards did not address MRI safety. In February 2008, the Joint Commission released Sentinel Event Alert # 38, Preventing Accidents and Injuries in the MRI Suite, which outlined 10 explicit objectives for enhancing provider-level MRI safety, nine of which are in direct response to the unique physical hazards in the MRI environment (Gilk, 2008). The full Sentinel Event Alert # 38 is in Appendix A. E. MRI Safety Concerns Prompt FDA Meeting October 13, (2011). A meeting of the FDA was held on October 13, 2011, to address concerns regarding accidents and injuries related to MRI s. These injuries included thermal burns, projectiles, implantable devices, and hearing loss (Howell, 2011). Data from the User 17

20 Facility Device Experience database indicated patients were sustaining injuries during the MRI process (2011). It was stated that the number of injuries spiked four-fold from 2004 thru 2009 but it could not be determined if more accidents were occurring or if reporting of injuries was increasing. It is likely that the actions created by the Joint Commission influenced the numbers of accidents being reported. Additionally, the numbers of MRI s being ordered increased as the providers were identifying new reasons for using this technology because of the significant information it can provide. Either way, the fact that various injuries were being identified created the need for determining what could be done to prevent these injuries while maintaining the use of this technology. As stated by a representative of the FDA s Center for Devices and Radiological Health Division of Physics Biophysics Laboratory, Given the new experience base, this is a good time for FDA to learn what MR practices are being used and what changes practitioners feel would improve safety in the MR environment (Rajan, 2011). F. ACR Guidance on MR Safe Practices: 2013 In 2013, a panel of experts were again assembled to review, modify and update the document on Safe MR Practices because of the many changes that had occurred in this industry since The numbers of MRI s being done continued to grow as the strength of the magnets increased enabling attainment of new and improved images. This led to the building of more and more MRI sites which needed to be designed to meet the changing standards and designs. As result of the work of this panel, the next edition of the ACR Guidance Document on Safe MR Practices: 2013 was developed and made available for immediate use. Standards of practice should be developed for each facility that allow practitioners to meet the intent of the ACR Guidance material. Each person on the MRI team must achieve compliance with the standards and be knowledgeable of how their practice indicates how the standards are being met. The topics this Guidance Document covered included: A. Establish, implement, and maintain that Current MR Safety is being met at their place of employment, since these ACR Policies and Procedure B. Static Magnetic Field Issues: Site Access Restriction MR Technologist C. Pregnancy Related Issues D. Pediatric MR Safety Concerns 18

21 E. Time Varying Gradient Magnetic Field Related Issues: Induced Voltages F. Time Varying Gradient Magnetic Field Related Issues: Auditory Considerations G. Drug Delivery Patches and Pads H. Cryogen-Related Issues I. Claustrophobia, Anxiety, Sedation, Analgesia and Anesthesia J. Contrast Agent Safety K. Intracranial Clips Patients in Whom There Are or May Be L. Patients in Whom There Are or May Be Cardiac Pacemakers or Implantable Cardioverter Defibrillators Appendix: 1. Personnel Definitions 2. Safety Screening Form 3. MR Facility Design Guidelines 4. MR Facility Emergency Preparedness Guidelines 5. References The Table of Contents on what is covered in the 2013 document is provided here so the reader can see the extent of what has been addressed. The document is 30 pages in length a significant amount of information that represents what is required for a safe practice in this area of healthcare. While those who practice in the MR area of a facility are not expected to memorize each piece of information, he/she is expected to know what is covered in the document, to know the policies and procedures that have been developed from the information in the document, and to know how to access the document when needed. Each organization providing MR services will have policy and procedure manuals for that specific organization that are based upon and reflective of the ACR Guidance on MR Safe Practices: To ensure all major components of this service are addressed, organizations should consider using the ACR Guidance document as a format for the development of the policies and procedures, adding facility-specific aspects that need to be addressed. VIl. Example of What Should be Included in an MRI Policy/Procedure Manual (based on the information in the ACR Guidance Document on Safe MR Practices 2013) 19

22 The following is a delineation of what should be included an MRI Policy/Procedure Manual for your facility. The major topics are listed to guide the discussion and selection of information that should be included to provide what is needed by the staff to maintain safe and effective practices in an MR suite. Information needed to add the required substance to each of the topics can be found in the ACR Guidance Document on Safe MR Practices: It is also recommended that staff work with the hospital/agency safety officer to assure the most current MRI practices are included in the MRI policy/procedure manual. MRI Safety Policy and Procedure Manual An intraoperative magnetic resonance imaging (MRI) suite is a high-risk zone that requires well-defined safety procedures to avoid adverse events related to magnetic forces. The opening of an MRI suite requires the development of policies/procedures to establish guidelines, procedures, education, and care specific to the use of MRI technology in the operative environment. These policies and procedures should be developed by a multidisciplinary team so all functions in the MR Suite are addressed (AORN, 2013). Developing this manual by staff in your facility ensures the expectations represent both the ACR standards as well as the expectations/philosophies of your agency. 20

23 The index might read like this: Establish, Implement and maintain current MR safety policies and procedures 1. All clinical and research MR sites should maintain MR safety policies. 2. These policies and procedures should be reviewed concurrently with the introduction of any changes in safety parameters. 3. The policies and procedures for XYZ Facility are in Section X. MRI Safety Education 1. Measurement 2. Features of the magnetic field that are the sources of most MRI incidents 3. The educational calendar is in the staff meeting room 4. Individual staff educational completion records are available from the supervisor Hazards in the MRI Suite 1. The missile effect 2. Torque forces 3. Induced magnetic field 4. Thermal heating 5. Patient discomfort 6. Contrast agents Information on How to Avoid These Hazards/How to Report the Presence of Hazards follows Section 6 of this Manual Establishing and Implementing Best Practices 1. Safety Guidelines 2. Access Zones 3. Training Protocols 4. MRI Suite Room Design 5. Information on The Best Practices is in the Education Class Room. 6. Patient and Non-MRI Personnel Screening 7. Patient Safety and Care 8. Cryogenic Care Summary of Safety Guidelines 21

24 An excellent example of this model is the UC Davis Imaging Research Center-MRI Safety Guidelines. This document is available on-line at: It is important to note that as quickly as the issues of unsafe care related to the use of MRI s were identified, the American College of Radiology convened a panel to define steps to reduce the risks of harm to patients and staff. The College worked to review changes in the use of MRI that required revisions/additions to the ACR Guidance Document on Safe MR Practices. Additionally, the Joint Commission focused on compliance with the practices defined by the ACR. The full report can be obtained by going to: The extent of the information in the document represents how the smallest oversight can lead to serious injuries or death to the patient, staff, or other individuals in the area. VIIl. The Next Generation You have read the information describing accidents in the MRI Suite and can identify how easy it is to miss finding the scissors in the pocket of a staff member or a paper clip somewhere on the chart that is taken into the Suite. It is also clear that a full screening of each staff person and the patient takes a significant amount of time which limits the number of studies that can be done in a facility. An announcement of a new, next-generation scanner was made on July 21, The information regarding this announcement follows: TWINSBURG, Ohio, July 21, 2015 /PRNewswire/ -- CEIA USA, Ltd., a premier provider of safety and security screening systems, today announced the availability of the CEIA Healthcare Detection Systems metal detection technology for MRI Safety Screening. The CEIA MetalMag walk-through detector and CEIA PD240CH hand-held detector combine the benefits of both cutting-edge metal detection and ferromagnetic detection functionality to automatically filter and suppress alarms for non-threat items, without compromising the required threat item detection capabilities. As a result, the new systems end false alarm fatigue and guesswork. One can be certain there will be considerable innovations by the MRI community to continue to develop and provide equipment that can protect the patient and staff as much as possible. 22

25 MRI safety screening is essential for both patients and staff and should be simple, fast and highly effective every time. The MetalMag walk-through detector automatically detects a wide variety of metallic items and ferromagnetic material threat items, such as scissors, that are considered dangerous in MRI environments all while eliminating unnecessary false alarms for non-threat items such as shoes, eyeglasses and even underwire bras. The MetalMag features CEIA's precision multi- zone targeting indication to pinpoint the exact location of the dangerous item on the person or in the body of the individual in transit. As a freestanding unit it does not require any specialized installation and can be quickly deployed prior to the MRI screening control point in any facility. These solutions were collaboration with Aegys product and process MRI safety and improve developed in -- an innovator of solutions that enhance efficiency. The literature in 2001 regarding adverse events in MRI suites indicates that the number of these events is quite small primarily because MR personnel typically adhere to safety protocols (ECRI, 2001, p.1). It was also noted that it is likely that near-misses do occur and these are never reported. One thing that all successful safety officers know is that the reporting of near-misses, in any facility, is what helps develop plans to keep the near-misses from becoming full-blown errors. Near-misses are what brings potential errors to the attention of all who can make the needed corrections before that error is committed. The year 2004 was the last year in which the FDA recorded a decline in the number of MRI accidents and the number of accidents has increased 300% since that date (Metrasense, 2009, p.1). The use of MRI s only increased 3% per year so it does not appear that an increase in numbers of tests completed is the cause of the significant increase in accidents. Improved reporting of accidents might be considered as a reason for the dramatic increase in the number of accidents. However, increased reporting at the level that 23

26 would need to be in place did not likely occur since there was no governmental or professional group working to increase awareness of reporting criteria (Metrasense, 2009, p. 2). Remember, the Joint Commission did not become involved until The FDA concluded that there was most-likely an increase in harming MRI patients but the data does not implicate any single risk factor. IX. A Culture of Safety When thinking about safe MRI practices or patient safety in any place in healthcare, there needs to a culture of safety as the framework from which safety practices are developed and implemented. A culture represents the values, beliefs and behaviors within a group (Galanes & Adams, 2010). An additional characteristic of an effective safety culture is one in which a proactive approach is used to prevent harm rather than waiting until an event happens and then working to determine how it could have been prevented. Organizations which appear to work within a culture of safety are likely to have open communications with the group, and are likely to have a sense of trust in their fellowworkers as they share actions which demonstrate that safety is important to them. They also focus on prevention of errors whenever discussing a new plan, policy and/or program. Looking closely at all aspects of a new element of practice will generally lead one to the weaknesses in the practice that need to be addressed before implementation. Safety Cultures have the following characteristics: Realizing the high-risk nature of the work being done Determination to achieve safety on consistent basis A blame-free environment Collaboration among all providers to find solutions to patient safety issues Resources and commitment by the organization to address safety concerns This culture comes from the top Safety in openly discussing near misses and adverse events Is not dependent on one leader or group 24