Rhode Island Physician Ebook Continuing Education

This interactive Rhode Island Physician Ebook contains 12 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.

Rhode Island Continuing Medical Education

2024 Rhode Island Medical Licensure Program

SATISFIES THE DEA’S NEW ONE-TIME MATE REQUIREMENT DEA REQUIREMENT (NEW) 8 HOURS Substance Use Disorders SATISFIES MANDATORY CME REQUIREMENT ON PUBLIC HEALTH TOPICS PUBLIC HEALTH TOPICS 4 HOURS

INCLUDES: DEA’s new one-time MATE requirement

CME FOR:

AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE

RI.CME.EDU

InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

2024 RHODE ISLAND

01 MEDICAL ERRORS AND THE UNITED STATES HEALTHCARE SYSTEM COURSE ONE | 2 CREDITS*

IMPROVING ACCESS TO CARE FOR LGBTQ PATIENTS COURSE TWO | 2 CREDITS*

LEARNER RECORDS: ANSWER SHEET & EVALUATION REQUIRED TO RECEIVE CREDIT SUBSTANCE USE DISORDERS: A DEA REQUIREMENT COURSE THREE | 8 CREDITS**

*Completion of both Courses One & Two satisfies the mandatory CME requirement of at least four (4) hours on Public Health Topics of current concern. **Satisfies the DEA'S New One-Time Mate Requirement

Program Options

$110 ENTIRE PROGRAM

12 Credits

$50 • Medical Errors and the United States Healthcare System • Improving Access to Care for LGBTQ Patients $80 • Substance Use Disorders: A DEA Requirement

4 Credits

8 Credits

CME that counts for MOC Participants can earn MOC points equivalent to the amount of CME credits claimed for designated activities (see page iii for further details). InforMed currently reports to the following specialty boards: the American Board of Internal Medicine (ABIM), the American Board of Anesthesiology (ABA), the American Board of Pediatrics (ABP), the American Board of Otolaryngology–Head and Neck Surgery (ABOHNS), and the American Board of Pathology (ABPath). To be awarded MOC points, you must obtain a passing score, complete the corresponding activity evaluation, and provide required information necessary for reporting.

DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.

InforMed has joined the Elite Learning family Two of the nation’s top healthcare education providers have joined forces with one goal in mind: to offer physicians a state-of-the-art learning experience that fulfills your state requirements and empowers you with the knowledge you need to provide the best patient care. Here’s what you can expect from our new partnership: • COURSES: In addition to the mandatory courses you need to renew your state license, you’ll now have access to dozens of hours of elective courses and an expanded content library. • ACCOUNTS: You’ll also have access to a personalized learner account. In your account you can add, organize, and track your ongoing and completed courses. For instructions on how to set up your account, email us at office@elitelearning.com. • BOOK CODES: You may notice a book code on the back cover of the latest InforMed program you’ve received in the mail. When entered on our new site, this code will take you directly to the corresponding self-assessment. See more information below. How to complete Please read these instructions before proceeding.

Read and study the enclosed courses and answer the self-assessment questions. To receive credit for your courses, you must provide your customer information and complete the mandatory evaluation. We offer three ways for you to complete. Choose an option below to receive credit and your certificate of completion. Scan this QR code to complete your CE now !

Fastest way to receive your certificate of completion

Online

• Go to BOOK.CME.EDU . Locate the book code RI24CME found on the back of your book and enter it in the box then click GO . If you would like to choose a different program option, use the table below and enter the corresponding code in the box. • If you already have an account created, sign in to your account with your username and password. If you do not have an account already created, you will need to create one now. • Follow the online instructions to complete your self-assessment. Complete the purchase process t o receive course credit and your certificate of completion. Please remember to complete the online evaluation.

Enter book code

Example: RI24CME

If you need help finding your code, Browse Book Code FAQs

Program Options

Code

Credits

Price

Entire Program

RI24CME

$110.00

Courses 1 and 2

RI24CME -50

$50.00

Course 3

RI24CME-80

$80.00

By mail

By fax

• Fill out the answer sheet and evaluation found in the back of this booklet. Please include a check or credit card information and e-mail address. Mail to InforMed, PO Box 2595, Ormond Beach, FL 32175-2595 . • Completions will be processed within 2 business days from the date it is received and certificates will be e-mailed to the address provided.

• Fill out the answer sheet and evaluation found in the back of this booklet. Please include credit card information and e-mail address. Fax to 1-800-647-1356 . • All completions will be processed within 2 business days of receipt and certificates will be e-mailed to the address provided.

• Submissions without a valid e-mail will be mailed to the address provided.

BOOK.CME.EDU

BOOK CODE: RI24CME

1-800-237-6999

INFORMED TRACKS WHAT YOU NEED, WHEN YOU NEED IT

Rhode Island Professional License Requirements

DEA ONE-TIME MATE REQUIREMENT (NEW) Effective June 27, 2023 , renewing DEA-registered practitioners must complete eight (8) hours of one-time training on the treatment and management of patients with opioid or substance use disorders. PHYSICIANS (MD/DO): All physicians licensed to practice allopathic or osteopathic medicine are required to document to the Board of Medical Licensure and Discipline that they have earned a minimum of forty (40) hours of AMA PRA Category 1 Credits TM /AOA Category 1-A CME credit or equivalent biennially prior to renewal. MANDATORY CME ON PUBLIC HEALTH TOPICS At least four (4) hours of continuing medical education shall be earned on topics of current concern as determined by the director of the Rhode Island Department of Health. Current topics include: Cultural Awareness, Risk Management, and Antimicrobial Stewardship.

Department of Health 3 Capitol Hill Providence, RI 02908 P : 401-222-5960 We are a nationally accredited CME provider. For all board-related inquiries please contact:

COMPLETION DEADLINE: 6/30/2024

LICENSE TYPES: MD/DO

Disclaimer: The above information is provided by InforMed and is intended to summarize state CE/CME license requirements for informational purposes only. This is not intended as a comprehensive statement of the law on this topic, nor to be relied upon as authoritative. All information should be verified independently.

Table 1. MOC Recognition Statements Successful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit. Board Programs ABA American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0® MOC/MIPS CREDIT INFORMATION In addition to awarding AMA PRA Category 1 Credits TM , the successful completion of enclosed activities may award the following MOC points and credit types. To be awarded MOC points, you must obtain a passing score and complete the corresponding activity evaluation.

ABIM

American Board of Internal Medicine’s Maintenance of Certification (MOC) program

American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC)

ABOHNS

ABPath

American Board of Pathology’s Continuing Certification Program

ABP

American Board of Pediatrics’ Maintenance of Certification (MOC) program

Table 2. Credits and Type Awarded

AMA PRA Category 1 Credits TM 2 AMA PRA Category 1 Credits TM 2 AMA PRA Category 1 Credits T M 8 AMA PRA Category 1 Credits T M

Activity Title

ABA ABIM ABOHNS ABPath

ABP

Medical Errors and the United States Healthcare System Improving Access to Care for LGBTQ Patients

2 Credits LL 2 Credits LL 8 Credits LL

2 Credits MK 2 Credits MK 8 Credits MK

2 Credits SA 2 Credits SA 8 Credits SA

2 Credits LL 2 Credits LL 8 Credits LL

2 Credits LL+SA 2 Credits LL+SA

Substance Use Disorders: A DEA Requirement 8 Credits LL+SA Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, LL+SA = Lifelong Learning & Self-Assessment, PS = Patient Safety

Table 3. CME for MIPS Statement Completion of each accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Participation in this Clinical Practice Improvement Activity (CPIA) is optional for eligible providers.

iii

MEDICAL ERRORS AND THE UNITED STATES HEALTHCARE SYSTEM

Release Date: 5/2022 Exp. Date 4/2025 2 AMA PRA Category 1 Credits ™ COURSE DATES: MAXIMUM CREDITS:

FORMAT:

Enduring Material (Self Study)

TARGET AUDIENCE This course is designed for physicians (MD/DO) and all other health care professionals.

HOW TO RECEIVE CREDIT:

• Read the course materials.

• Co mplete the self-assessment questions at the end. A score of 70% is required. • Ret urn your customer information/ answer sheet, evaluation, and payment to InforMed by mail, phone, fax or complete online at program website.

The purpose of this course is to update physicians on the continuing impacts and challenges of medical errors for the healthcare system in the United States and to provide strategies to address root causes of these errors. COURSE OBJECTIVE

LEARNING OBJECTIVES

Completion of this course will better enable the course participant to: 1. Review terminology and categories of medical errors. 2. Understand how to conduct a root cause analysis to identify and correct errors.

3. Identify factors that contribute to medical error occurrence. 4. Describe strategies for reducing common medical errors.

ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. IMPLICIT BIAS IN HEALTHCARE Implicit bias significantly affects how healthcare professionals perceive and make treatment decisions, ultimately resulting in disparities in health outcomes. These biases, often unconscious and unintentional, can shape behavior and produce differences in medical care along various lines, including race, ethnicity, gender identity, sexual orientation, age, and socioeconomic status. Healthcare disparities stemming from implicit bias can manifest in several ways. For example, a healthcare provider might unconsciously give less attention to a patient or make assumptions about their medical needs based on race, gender, or age. The unconscious assumptions can lead to delayed or inadequate care, misdiagnoses, or inappropriate treatments, all of which can adversely impact health outcomes. Addressing implicit bias in healthcare is crucial for achieving equity in medical treatment. Strategies to combat these biases involve education and awareness programs for healthcare professionals. These programs help individuals recognize and acknowledge their biases, fostering a more empathetic and unbiased approach to patient care. Additionally, implementing policies and procedures prioritizing equitable treatment for all patients can play a pivotal role in reducing healthcare disparities. Ultimately, confronting implicit bias in healthcare is essential to creating a more just and equitable healthcare system where everyone receives fair and equal treatment regardless of their background or characteristics.

DESIGNATION STATEMENT InforMed designates this enduring material for a maximum of 2 AMA PRA Category 1 Credits™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

FACULTY Russell Yoon, MD Emergency Medicine Department Cooper University Health Care Donna M. Moccio, BS Medical Writer mL medcom, Inc.

As a condition of biennial renewal, all physicians (MD/DO) are required to complete at least four (4) hours of CME on topics of current concern as determined by the director of the Rhode Island Department of Health. Current topics include: Cultural Awareness, Risk Management, and Antimicrobial Stewardship. This course satisfies two (2) hours on Risk Management. SPECIAL APPROVAL: 2 Risk Management COURSE SATISFIES

ACTIVITY PLANNER Michael Brooks Director of CME InforMed

DISCLOSURE OF INTEREST In accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

FACULTY/PLANNING COMMITTEE DISCLOSURE The following faculty and/or planning committee members have indicated they have no relevant financial relationship(s) to disclose with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: • Russell Yoon, MD • Donna M. Moccio, BS • Michael Brooks

STAFF AND CONTENT REVIEWERS InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

DISCLAIMER *2024. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.

• An estimated 29% of Medicare patients in rehabilitation hospital stays experienced an adverse event and half of these were considered preventable, which is similar to findings regarding adverse events in hospitals and skilled nursing facilities (27% and 33%, respectively. 7 • An assessment of the frequency and types of errors identified by patients who read open ambulatory visit notes found 20% of patients who read a note reported finding a mistake and 40% perceived the mistake as serious. Among patient-reported very serious errors, the most common characterizations were mistakes in diagnoses, medical history, medications, physical examination, test results, notes on the wrong patient, and left vs right side. 8 Medical Error or Unintended Consequence? The term medical error captures all the unintended events that occur during a patient’s care cycle. These can be as innocent as the wrong doctor’s name placed into a chart, or a missed dose of medication that has no consequences to the patient. Some medical errors are discovered before any harm occurs, and some are so benign they go completely unnoticed. 9 Some clinicians believe that the term medical error is excessively negative, antagonistic, and perpetuates a culture of blame. Many experts suggest the term medical error should not be used at all, because, for example, an adverse medication event could be an unintended consequence of a therapeutic intervention. However, adverse patient outcomes may occur because of medical errors and to delete the term obscures the goal of preventing and managing its causes and effects. 10

Regardless of the nomenclature, medical errors typically occur from the convergence of multiple contributing factors. Public and legislative intolerance for medical errors typically illustrates a lack of understanding that some errors may not be preventable with current technology or the resources available to the practitioner. 11 The trend is for patient safety experts to focus on improving the safety of healthcare systems to reduce the probability of errors and mitigate their effects rather than focus on an individual’s actions. Medical errors represent an opportunity for constructive changes and improved education in healthcare delivery. 11 TERMINOLOGY Medical error is defined as harm to a patient that results from either. 12, 13 • The failure of a planned action to be completed as intended or • The use of a wrong plan to achieve an objective. Medical error can be associated with failures in medical practice, products, procedures, and/or systems. Medical error requires two critical parts: harm and whether the harm or error could have been prevented. 12 Other terms related to medical error include. 12-14 • Safety: Freedom from accidental injury. •

INTRODUCTION

Medical errors are an under-recognized cause of death in the United States. Error rates are significantly higher in the United States compared with other developed countries such as Canada, Australia, New Zealand, Germany, and the United Kingdom. 1 Patient safety experts at Johns Hopkins analyzed medical death rates over an 8-year period and estimated that >250,000 deaths each year are due to medical error in the United States (Figure 1). 2 This statistic makes medical errors the third highest cause of death in the United States, accounting for 10% of all deaths. 2 Unfortunately, the way that the Centers for Disease Control and Prevention collects national health statistics fails to classify medical errors separately on death certificates. Because medical errors are not listed, they do not get the public attention given to other leading causes of death such as cancer and heart disease. 2 Medical errors increase personal and institutional financial burdens, adding an estimated $20 billion to US healthcare costs annually. 3 Beyond the emotional toll on the patient, medical errors have substantial negative effects on the mental and emotional well-being of the providers who are involved. 4 These negative effects include guilt, shame, anxiety, fear, depression, posttraumatic stress disorder and suicidality. 4 Although improvement has occurred in specific areas, significant challenges remain. For example: • One in two surgeries involved a medication error and/or an adverse drug event. 5 • Approximately 5% of all adult Americans experience a diagnostic error in outpatient settings every year. 6

Adverse drug event: Injury resulting from the use of a drug caused by an adverse drug reaction, a medication error, or an overdose. An adverse drug event frequently necessitates discontinuation of the drug and potentially administering an antagonist. Adverse drug reaction: Unavoidable, appreciably noxious, or unpleasant reaction that occurs during the normal, proper use of a medical product. Some drug reactions may be minor and temporary; others have the potential to be permanent and serious. Medication errors: Errors that occurs due to mistakes made in the processes of the drug’s prescribing, transcribing, dispensing, administering, or monitoring. Near-miss: Error that is detected and corrected before harm can be done. Sentinel event: Unexpected occurrence involving death or serious physical or psychological injury, or the risk of death or such an injury. A sentinel event indicates the need for immediate investigation and response. The terms “sentinel event” and “error” are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. Root Cause Analysis: Root cause analysis is a process for identifying factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. ° A root cause analysis focuses primarily on systems and processes, not on individual performance.

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Medical Errors _V2 March 31, 2020

Figure 1. Death in the United States

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Medical errors increase personal and institutional financial burdens, adding an estimated $20 billion to US healthcare costs annually. 3 Beyond the emotional toll on the

The analysis progresses from special causes in clinical processes to common causes in organizational processes and systems and identifies potential improvements in these processes or systems. The goal is to decrease the likelihood of such events in the future by implementing strategies to prevent the event from occurring again. CATEGORIES OF MEDICAL ERRORS

one healthcare associated infection. 21 The main types of infection include: pneumonia (22%), surgical site infections (22%), gastrointestinal infections (17%), and device associated infections, which include central line infections, catheter-associated UTI, and ventilator-associated pneumonia (26%). 22 It is impossible to estimate the percentage of hospital acquired infections that are avoidable, but evidence shows that many of these infections can and should be prevented. For example, failure to conform to hand hygiene standards can lead to preventable infections. 21 Surgical errors: Wrong-site, wrong-procedure, wrong-patient errors should never occur and indicate serious safety problems within an organization. Recent studies show that these types of errors occur in about one of 112,000 surgical procedures or that an individual hospital would experience such an error every five to 10 years. However, these data sets only include procedures in the operating room. If procedures performed in other settings, such as ambulatory surgery centers, were to be included, the rate of such errors may be significantly higher. 23 Pharmacy errors: Pharmacy errors can involve such issues as the preparation or processing of a prescription or giving incorrect directions to patients. Researchers at a tertiary care medical center in Houston, Texas, recently monitored 1,887,751 medication orders, 92 medication error events, and 50 pharmacists. They determined that the overall error rate was 4.87 errors per 100,000 verified orders. Pharmacy errors were associated with workload, work environment, and number of pharmacists per shift. Factors such as the type of pharmacy degree, age, experience, and the number of years at an institution may also influence the error rate. 24 Laboratory errors: Errors made in the laboratory can be technical, procedural, or the result of poor communication. The ECRI Institute evaluated 2,420 mistakes that occurred between 2011 and mid-2013. Only 4% of reported potentially harmful errors occurred in the laboratory itself. Nearly 75% of mistakes occurred in the pre-analytic stage, defined as the time frame in which tests are selected and ordered, specimens are identified and transported, and patients are prepared. Such mistakes were more likely to be linked to labels that had the wrong patient’s name, the wrong specimen ordered, and incomplete or missing information. The other 22% occurred in the post-analytic stage, when results were interpreted, reported, or stored. 25

ROOT CAUSE FACTORS THAT CONTRIBUTE TO MEDICAL ERRORS The causes and prevention of medical errors are the focus of considerable academic and professional attention. For accreditation purposes, the Joint Commission requires that healthcare institutions have a comprehensive process for the systematic analysis of sentinel events. 26 Reporting of sentinel events by accredited organizations is voluntary, and it is estimated that less than 2% of all sentinel events that occur in healthcare are reported to The Joint Commission. The most frequently reported sentinel events in 2020 were fall (n=170), unintended retention of a foreign object (n=106); suicide (n=81); delay in treatment (n=76); wrong side-surgery (n=68); assault/ rape/sexual assault (n=47); fire (n=30); clinical alarm response (n=27); self-harm (n=24); and medication management (n=24). 27 The Office of Quality and Patient Safety at The Joint Commission works with organizations reporting sentinel events to identify contributing factors and actions the organization can take to reduce risk. 27 The root cause analysis (RCA) process is one of the most commonly used tools by institutions to optimize patient care and enact measures to mitigate adverse events. RCA is primarily based on system-level process. The RCA starts with a designated team that reviews and identifies required changes at the systemic level, improving performance and reducing the likelihood of another sentinel event. Failure to perform an RCA within 45 days of the occurrence of a sentinel event may result in the healthcare institution being placed on an ‘accreditation watch,’ which is public information. Repeat violations may result in an onsite review by the Joint Commission that may jeopardize accreditation. The Joint Commission has created a framework and series of 24 questions to aid in organizing an RCA. This framework is recommended to be used as a general template when preparing the RCA report that will eventually be submitted to the Joint Commission after thorough evaluation. 26 The 24-question framework recommended by the Joint Commission considers a variety of situational factors that may have contributed to a sentinel event. This includes examining the systematic process, human factors, equipment malfunctions, environmental factors, uncontrollable external factors, organizational factors, staffing and qualifications, contingency plans, performance expectations, informational disruptions, communication, environmental risks, training, and technology (Table 1). 26 Prevention strategies typically address the three most common causes of medical errors: communication, planning and knowledge, and systemic or institutional failure. Communication Accurate communication is vital for diagnosing, treating, dispensing and administering medications, maintaining patient safety, following policies and procedures, and ensuring treatment instructions are carefully followed.

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Many preventable adverse events can be associated with more than one type of medical error. Although there are many different ways to categorize medical error, and categories may overlap, the following classifications are common. •

Misdiagnosis/Diagnostic errors: Diagnosis errors are errors that occur when a diagnosis is missed, wrong, or delayed. 15 Preventing medical misdiagnosis is a recognized national public health priority. 16 In their landmark 2015 report Improving Diagnosis in Healthcare, the National Academy of Medicine (NAM) stated that “most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.” 17 Diagnostic error rates in real-world practice are not known, but a commonly cited estimate is that 10–15% of all diagnoses are incorrect. 16 A 2021 review article found that missed vascular events, infections, and cancers account for 75% of serious harms from diagnostic errors and 15 diseases account for nearly half of all serious misdiagnoses. 16 Systems or process errors: Systems or process errors involve predictable human failings in the context of poorly designed systems. 18 Active errors: Active errors nearly always involve frontline staff members and occur at the point of contact between a human and some part of a larger system. 18 Latent errors: Sometimes referred to as “accidents waiting to happen,” latent errors involve failures of organization or design (e.g., systems and processes) that allow active errors to cause harm. 18 Medication errors: Medication errors are “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.” 19 The FDA receives approximately 100,000 reports each year associated with suspected medication error. These reports come from drug manufacturers, healthcare professional, and consumers through MedWatch, the Agency’s safety information and adverse event reporting program. 20 Infection-related errors: According to the U.S. Centers for Disease Control and Prevention (CDC) on any particular day, approximately one in 25 patients has at least

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Table 1. 24 Analysis Questions from the Joint Commission Framework for Root Cause Analysis and Corrective Actions. 27

1. What was the intended process flow?

13. Did staff performance during the event meet expectations?

14. To what degree was all the necessary information available when needed?

2. Were there any steps in the process that did not occur as intended?

Accurate? Complete? Ambiguous?

3. What human factors were relevant to the outcome?

15. To what degree is communication among participants adequate? 16. Was this the appropriate physical environment for the processes being carried out?

4. How did the equipment performance affect the outcome?

5. What controllable environmental affected the outcome? 6. What uncontrollable external factors influenced the outcome? 7. Were there any other factors that directly influenced this outcome? 8. What are the other areas in the healthcare organization where this could happen? 9. Was staff properly qualified and currently competent for their responsibilities? 10. How did actual staffing compare with ideal level? 11. What is the plan for dealing with staffing contingencies?

17. What systems are in place to identify environmental risks?

18. What emergency and failure-mode responses have been planned and tested?

19. How does the organization’s culture support risk reduction?

20. What are the barriers to communication of potential risk factors?

21. How does leadership address the continuum of patient safety events, including close calls, adverse events, and unsafe, hazardous conditions?

22. How can orientation and in-service training be improved?

23. Was available technology used as intended?

12. Were such contingencies a factor in this event?

24. How might technology be introduced or redesigned to reduce risks in the future?

Communication errors can be verbal or written and occur in every part of the care delivery process. Breakdowns in communication are one of the leading causes of medical errors. The Joint Commission reports that, according to an RCA of over 4,000 adverse events, 70% were caused by communication breakdowns. 28 Such breakdowns can include inadequate patient handoffs, interpersonal communication failures, and reluctance to admit a lack of knowledge or failure to seek clarification. Planning and Knowledge Planning and knowledge failures can encompass virtually every aspect of care delivery, and the different types of errors that can be caused by failure in planning and knowledge are almost limitless. 12, 13 It is therefore essential healthcare professionals work together to establish the most effective plan of care for each patient to ensure that all members of the healthcare team have the necessary knowledge and skills to implement the plan of care, and to evaluate the effectiveness and safety of the plan as it is implemented. Systemic or Institutional Failures The Institute of Medicine (IOM) reports medical errors are more often due to poor systems than negligent practitioners. System failures involve poor planning and execution, inappropriate or absent policies and procedures, failure to procure and maintain equipment, failure to hire and retain staff, failure to maintain safe staffing levels, failure to monitor care, and failure to recognize errors and correct the conditions that caused the errors. 12, 13 While systemic failures in communication, infection control, and medication prescribing, dispensing, and administration have contributed considerably to medical error, entrenched healthcare traditions (e.g., using blame and shame, closing ranks, and strategies that minimize legal liability) have played a major role in discouraging disclosure necessary to reduce the risk of medical error.

Personal behavior is in one sense the least changeable aspect of medical error prevention. Healthcare professionals are not motivated to disclose medical error if policies and procedures focus on punishment rather than timely reporting and prevention. While individuals bear responsibility for their actions when a medical error occurs, the traditional blame and shame culture of healthcare is counterproductive if the goal is reducing error. First, it discourages voluntary reporting; second, it does not assess whether there was a system contribution to the error; and third, it focuses on assigning blame and punishment, not on why the error occurred, or on error prevention. 12 13 Some suggest healthcare medical error reporting would be more effective if modeled on alternative reporting systems, such as those used in the aviation industry, which has a very high level of safety. Aviation reporting guidelines do not absolve individuals of responsibility and punishment for errors, but instead treat each incident as a complex event with many possible causes and contributing factors. 12, 13 Root Cause Analysis of Adverse Events Reports From Emergency Departments in the Veterans Health Administration The ED is an important area to focus improvement efforts because it serves as the initial point of care for a majority of the population. Since 1997, the number of ED visits per year in the United States has increased by 23%, which amounts to a total of 141.4 million individuals using emergency care services in 2014, more than half of which are for nonurgent reasons. In addition, a large variety and number of conditions are treated, which make errors more likely. Because 70% of errors in the ED are preventable, the IOM identified the ED as a prime area for patient safety improvement. 29 A recent retrospective study used RCA reports of adverse events occurring in Veterans Health Administration EDs to understand the range of

events that were happening and to determine the primary causes of these events as well as actions to prevent them. 28 Safety reports from EDs from Veterans Health Administration medical centers across the nation for a two-year period (2015– 2016) were coded by event type, root cause, and recommended actions. The most common adverse events were as follows: delays in care (26.4%), elopements (n14.6%), suicide attempts and deaths by suicide (10.4%), inappropriate discharges (10.4%), and errors in following procedures (9.7%). The most common root cause categories leading to adverse events were knowledge/ educational deficits (11.4%), policies/procedures needing improvement (11.1%), and lack of standardized policies/procedures (9.4%). 29 Overall, 44.4% of cases were associated with no injury, 22.2% with moderate injury resulting in increased length of stay, 17.4% with major injury resulting in permanent injuries, and 16.0% resulted in catastrophic injury or death (Figure 2). 29 The authors noted that identifying the most severe ED adverse events and their preceding causes permits the development of action plans aligned to address root causes and the prioritization of action plan implementation. 29 ADDRESSING ROOT CAUSES: STRATEGIES FOR REDUCING COMMON MEDICAL ERRORS Human error is inevitable. Although we cannot eliminate human error, we can better measure the problem to design safer systems mitigating its frequency, visibility , and consequences. Strategies to reduce death from medical care should include three steps: 1. Making errors more visible when they occur so their effects can be intercepted. 2. Having remedies at hand to rescue patients. 3. Making errors less frequent by following principles that take human limitations into account (Figure 3). 30

Medical Errors _V2 March 31, 2020 Medical Errors _V2 March 31, 2020

18 Another set of drugs are common causes of medication errors because they can be easily confused (e.g., Percocet ® [acetaminophen and oxycodone] confused with Vicodin ® [acetaminophen and hydrocodone]). The Institute of for Safe Medication Practices (ISMP) identified some specific medications classified as high-risk, meaning that they are associated with a heightened risk of causing significant patient harm when used inappropriately: 37 • Ephinephrine subcutaneous. • Epoprostenol (Flolan) IV. • Insulin U-500 (All forms of insulin are considered high-risk. Insulin U-500 has been singled out for special emphasis to bring attention to the need for distinct strategies to prevent the types of errors that occur with this concentrated form of insulin). the mediation is in the control of the healthcare professional, patient, or consumer.” 19 Medication errors are the most common type of medical error. About 1.3 million people are injured annually in the United States following such errors. 34 The incidence of medication errors varies according to patient population and clinical setting. Children and the elderly are more likely to be harmed by medication errors than other segments of the population; children are more susceptible to harm from dosing errors due to their small size, while older individuals tend to take more medications, increasing their potential for medical error and adverse drug interactions. Polypharmacy is not uncommon is patients older than 62 years. 35 Medication errors are more likely to occur in fast- paced, stressful environments such as intensive care units, where errors are more likely to be more severe and cause harm. 36 Data from the FDA show that the most common error involving medications was related to the administration of an improper dose of medicine, accounting for 41% of fatal medication errors. Administering the wrong drug and using the wrong route of administration each accounted for 16% of the errors. 34 Some drugs that are frequent causes of medication errors are commonly used (e.g., insulin and antibiotics). Others are sufficiently potent and there is little room for therapeutic error and substantial potential for harm from seemingly small mistakes (e.g., the cardiovascular drug nitroprusside, heparin, warfarin, insulin, or colchicine). • Magnesium sulfate injection. • Methotrexate, oral, nononcologic use. • Opium tincture. • Oxytocin, IV. • Nitroprusside sodium for injection. • Potassium chloride for injection concentrate. • Potassium phosphates injection. • Promethazine, IV. • Vasopressin, IV or intraosseous. In an effort to identify root causes, a great deal of attention focused on why medication errors occur. Among a variety of reasons or these mistakes are poor staffing, unskilled/new nurses, stress, personal error, and distraction.

Figure 2. Injury Severity of all RCA Cases

The authors noted that identifying the most severe ED adverse events and their preceding causes permits the development of action plans aligned to address root causes and the prioritization of action plan implementation. 27 Human error is inevitable. Although we cannot eliminate human error, we can better measure the problem to design safer systems mitigating its frequency, visibility, and consequences. Strategies to reduce death from medical care should include three steps: 1. Making errors more visible when they occur so their effects can be intercepted. 2. Having remedies at hand to rescue patients. 3. Making errors less frequent by following principles that take human limitations into account. 28 ADDRESSING ROOT CAUSES: STRATEGIES FOR REDUCING COMMON MEDICAL ERRORS Figure 3. Individual and System Responsibilities

The identification of errors needs to become more transparent. There needs to be standardized data collection and evaluation of the root cause of each error. Punishment is not helpful as it leads to the nondisclosure of errors or risk of error. Both individuals and hospital systems have unique responsibilities in the reduction of medical errors. 28 The identification of errors needs to become more transparent. There needs to be standardized data collection and evaluation of the root cause of each error. Punishment is not helpful as it leads to the nondisclosure of errors or risk of error. Both individuals and hospital systems have unique responsibilities in the reduction of medical errors. 30

A Partnership for Patients study described the most common medical errors in the United States. Nine core patient safety areas of focus were identified: 32 Adverse Drug Events (Medication Errors); Catheter Associated Urinary Tract Infections (CAUTIs); Central Line-Associated Bloodstream Infections; Injuries from Falls and Immobility; Obstetrical Adverse Effects; Pressure Ulcers; Surgical Site Infections; Venous Thromboembolism; Ventilator-Associated Events. The following are strategies might be used to enhance safety and decrease the occurrence of some of these core safety issues. Adverse Drug Events/Medication Errors: A medication error is an error, of commission or omission, at any step along the pathway that begins when a clinician prescribes a medication and ends when the patient actually receives the medication. An adverse drug event is defined as harm experienced by a patient as a result of exposure to a medication. The occurrence of an adverse drug event does not necessarily indicate an error or poor-quality care. It is estimated that approximately 50% of adverse drug events are preventable. 33 In some cases, an adverse drug event is an unseen consequence of a medication reaction with therapeutic intent. The incidence of medication errors is an issue of contention. Because definitions of medication errors can differ, many medication errors must be self-reported to be recorded, and data suggest a significant percentage of medication errors are not reported. 19 In addition, there is no central agency or institution responsible for collecting reports of medication errors, so no one knows how many medication errors actually occur. A medication error is defined as “any preventable event that my cause or lead to inappropriate medication use or patient harm while

Wrong-Site Surgery Wrong-Site Surgery Three primary strategies have been identified to reduce the likelihood of wrong-site surgery. 31 Preoperative Verification and Reconciliation. The verification and reconciliation process is typically initiated by the admitting nurse in the preoperative area, but ultimately includes all staff members. The process includes the verification of the procedure to be performed with the patient or patient representative and allows for review of all relevant documents. Any discrepancies are immediately resolved with the attending surgeon. Site Marking. The marking of the surgical site is a preoperative procedure that allows the surgeon to mark the surgical site after a verbal confirmation with the patient or patient representative, and the attending nurse. The site mark acts as a visual confirmation to not only the surgeon, but the entire surgical team. Timeout and Intraoperative Verification. The timeout is the final pause prior to initiating a surgical procedure and should include all staff participating in the procedure. Intraoperatively, a verification process should be utilized to ensure accuracy (site and side) for the consented procedure. Partnership for Patients Core Safety Measures Studies show the potential risk of some errors is far greater than others, with some likely to happen repeatedly.

Three primary strategies have been identified to reduce the likelihood of wrong-site surgery. 29 Preoperative Verification and Reconciliation . The verification and reconciliation process is typically initiated by the admitting nurse in the preoperative area, but ultimately

These data suggest the most common medication errors are related to an improper dose of medication, administering the wrong dose of medication or the wrong drug, or administering medication via the wrong route. 34 The FDA has also commented on common causes of medication errors as follows: poor communication; ambiguities in product names, directions for use, medical abbreviations, or writing; poor procedures or techniques; patient misuse because of poor understanding of the directions for use of the product; job stress; lack of knowledge or training; similar labeling or packaging. 38 The following list describes the most common causes of medication errors according to specific definitions: 37 • An action-based medication error is defined as the performance of an unintended. Examples of action-based medication errors would include selecting the wrong medication or administering an incorrect dose. • A rule-based medication error occurs because the provider did not follow proper rules or procedures for medication administration. • A memory-based medication error occurs

• Ensure that handoffs involve the transfer of essential information when the responsibility for care shifts from one provider to another. • Use barcode technologies and electronic health records with computerized prescriber order entry. • Involve pharmacists throughout a patient’s hospitalization. • Require providers who are administering medicine to wear a colored sash or vest to prevent interruptions. • Have two providers independently verify doses prior to administering medication. Central-Line Associated Bloodstream Infections: In 2020, 3,687 general acute care hospitals in the US reported 21,399 central-line associated blood stream infections, which represent a significant increase in infections between 2019 and 2020. 40 Strategies to reduce the incidence of central-line associated bloodstream infections are outlined below. Hand Hygiene: Proper hand hygiene is the most important infection control measure and the most effective way to prevent the transmission of healthcare-associated infections. 41 Maximum Sterile Barrier Precautions: Maximum sterile barrier precautions must be taken when inserting the venous catheter. These precautions include, not only the person inserting the catheter, but anyone assisting with the procedure and the patient as well. 42 Skin Antisepsis; An alcoholic chlorhexidine antiseptic should be used for skin preparation that contains more than 0.5% CHG in patients over 2 months of age. 42 Povidone- iodine or alcohol may be used in patients 2 months or younger. Skin antisepsis should be performed at the time of insertion and with every dressing change 43 Busby et al., 2015). Selection of Catheter Site: The site of insertion is important to optimal outcomes. The use of the subclavian site is preferred to the jugular or femoral sites in adults to minimize infection risk. 43 Dressing Change: Dressings for insertion sites must be impermeable to water vapor. They can be either sterile gauze or sterile transparent, which is semipermeable dressing that covers the catheter insertion site. Topical antibiotic ointments or creams should not be applied to the insertion site because of the possibility of promoting fungal infections or pathogen resistance. Dressings are changed when they become wet, loose, or soiled. 42 43 Assessment and Removal: The catheter should be removed as soon as it is no longer needed. The risk for infection increases with the length of time the device is left in place and decreases when the catheter is removed. 42, 43 Injuries from Falls and Immobility: Patient falls that cause serious injury are among the top 10 sentinel events reported to The Joint Commission Sentinel Even Database. 44 Falls are among the leading causes of injury and death among Americans older than 65 years .

Almost one-third of adults in this age group report a fall every year, and the annual cost of falls to Medicare is approximately $31 billion. 45 A study found that rates of falls were even higher in patients with chronic kidney disease, which is common in older adults with comorbidities. 46 The Joint Commission reports that from January 2009 through October 2014, the most common contributing factors contributing to reported falls included. 44 • Communication failures. • Deficiencies in the physical environment. • Failure to adhere to protocols and safety practices. • Inadequate assessment. • Inadequate staff orientation, supervision, staffing levels, or skill mix. • Lack of leadership. Pressure Ulcers: Although most hospital- acquired pressure ulcers area reasonably preventable, approximately 2.5 million Americans develop a pressure ulcer in US acute care facilities every year. 47 These injuries can result in extensive harm, including chronic wounds, and as many as 60,000 deaths annually. 47 Hospital-acquired pressure ulcers are responsible for a huge financial burden. According to a recent estimate, based on 2016 dollars, the national burden of hospital-acquired pressure ulcers could exceed $26.8 billion. The cost of treatment was estimated to be approximately $10,708 per person. 47 Approximately 59% of the costs associated with these ulcers are attributable to a small number of patients with stage 3 and 4 full-thickness wounds. 47 There are a number of factors that increase risk for pressure ulcers 48, 49 : • Advanced age: An elderly person’s skin has less subcutaneous fat, which leads to decreased protection from pressure. • Friction/Shear: Decreases the epidermal layer, reducing protection of the skin. • Hypotension: Increases the response of local tissues, making skin more vulnerable to breakdown. • Immobility: Lack of mobility can lead to sustained pressure on bony prominences. • Length of stay in critical care units: Longer stays are indicative of more critical conditions. Such conditions are generally associated with decreased mobility and position change and increased shear force, all of which increase the risk for skin breakdown. • Length of time on mechanical ventilation: Indicates inadequate oxygenation and the need to provide ventilation mechanically. Decreased oxygen levels mean decreased oxygen to body tissues, including the skin. • Moisture: Moisture (e.g., incontinence, sweat, failure to dry skin after bathing) contributes to skin breakdown. • Nutrition: Inadequate nutrition alters the proper state of the skin, contributing to skin breakdown.

when a provider forgets to perform a task or forgets important information about the patient. The provider may forget to give a dose of a medication, that the medication has been discontinued, or that the patient is allergic to the medication. Knowledge-based medication errors are errors that could be avoided with a reasonable and appropriate level of professional knowledge. If the provider is familiar with the drug and the patient, knowledge-based medication errors are avoidable. Knowledge-based medication errors can be general, specific, or expert : 37 °

•

A general knowledge-based error occurs when someone makes an error because of lack of or disregard for information that is considered general knowledge (e.g., warfarin can cause bleeding). A specific knowledge-based error occurs when someone makes an error because of lack of or disregard of information that would be considered specific knowledge (e.g., a patient is given warfarin even though the INR is high).

° An expert knowledge-based error occurs when someone makes an error because of lack of, or disregard, for information that would be considered expert knowledge (e.g., the failure to use genetic testing to check for variations in patient response prior to initiating therapy with warfarin). Strategies to decrease the risk of medication error include 28, 34, 39 : • Adhere to the eight rights of medication administration: right patient, right medication, right time, right dose, right route, right position, right documentation, and right to refuse.

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