3/31/2015. To Err Is Human: Building a Better Healthcare System (2000)

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1 To Err Is Human: Building a Better Healthcare System (2000) 1

2 Radiology Review Course ABR Non interpretive Skills March 31, 2015 Annemarie Relyea-Chew, JD, MS Associate Professor Radiology Adjunct Associate Professor BIME University of Washington School of Medicine University of Washington Department of Radiology Disclosure of Commercial Interest Neither I nor my immediate family members have a financial relationship with a commercial organization that may have a direct or indirect interest in the content of this presentation. 2

3 Disclosure Licensed attorney-at-law: Washington State Commonwealth of Massachusetts Federal Cited cases or legal opinions discussed during this presentation do not necessarily reflect the policies of the University of Washington. Non interpretive Skills Domains* Quality Improvement Patient Safety Professionalism & Ethics Compliance & Regulatory Research & Screening Imaging Information *Acknowledgement of primary source: urce%20guide.pdf 3

4 Choosing Wisely Five things patients and physicians should question ACR Recommendations: 1. Don t do imaging for uncomplicated headache; 2. Don t image for suspected PE without moderate of high pretest probability of PE; 3. Avoid admission or preoperative chest x-rays for ambulatory patients with an unremarkable history and physical exam; 4. Don t do CT for the evaluation of suspected appendicitis in children until after an US has been considered as an option; 5. Don t recommend follow-up imaging for clinically inconsequential adnexal cysts. Elements of informed consent purpose and nature of the procedure or treatment method by which the procedure or treatment will be performed risks, complications, and expected benefits or effects of the procedure or treatment risk of not accepting the procedure or treatment any reasonable alternatives to the procedure or treatment and the likely risks and benefits right to refuse the procedure or treatment 4

5 Informed Consent Patient has the right to withhold consent Patient has the right to withdraw consent Adequate information (benefits, potential risks) Absence of coercion (ie., obtain before entering suite) Decision-making capacity Reasonable decision making Emergencies: a physician may provide treatment or perform a procedure without consent to prevent serious disability or death or to alleviate great pain or suffering. Informed Consent ACR-SIR Practice Guidelines: When obtaining informed consent for image-guided procedures that may be associated with higher levels of radiation an explanation of the likelihood and characteristics of deterministic injury should be included in the consent discussion prior to the procedure. Ed01.pdf 5

6 ALARA and Dose Management GE & Toshiba overdose cases in CT perfusion studies Cedars-Sinai: ~ 206 patients received radiation over 8 x over expected levels California enacted SB 1237 requiring dose reporting in radiology reports DLP or CT dose index 6

7 ALARA and Dose Management March 2009: California hospital fined $25,000 by state regulatory agency for massive CT radiation dose to pediatric patient. Technologist error 2 year old boy 151 CT scans in 65 minutes Burns, substantial chromosomal damage 5.3 Gy to the brain and salivary glands, 7.3 Gy to the skin, and 1.54 Gy to the lenses of both eyes Image Gently Campaign 7

8 Step Lightly (fluoroscopy) 8

9 Why Professionalism and Ethics? Patient Care and Safety* Where a health care team is dysfunctional, i.e., a locus of unprofessional behavior, opportunities for error are created. *http://www.jointcommission.org/sentinel_event_alert_issue_40_behaviors_that_undermin e_a_culture_of_safety/ The ABIM: Medical professionalism in the new Millennium: a Physician Charter: Professionalism is the basis of medicine s contract with society. It demands placing the interests of patients above those of the physician ABIM Foundation + ACP-ASIM Foundation + European Federation of Internal Medicine AMA Code of Medical Ethics: ACR: Code of Ethics; Principles of Ethics: Rules of Ethics 015%20Code%20of%20Ethics.pdf 9

10 Professionalism Attributes of the medical professional: skilled undergraduate graduate medical training post-graduate training Professionalism Attributes of the medical professional: competent certification licensure boards CME MOC 10

11 Professionalism Attributes of the medical professional: character patient autonomy primacy of patients social justice ABIM: The Physician Charter: fundamental principles are the primacy of patient welfare, patient autonomy and social justice. Ethics Ethical norms are derived from: Societal expectations Professional: standards of care, policies Legal: malpractice, malfeasance Institutional policies Fiduciary obligations 11

12 Professionalism Regulatory Conflict of Interest (COI) Stark Rule (prohibition against self referral) Analogous state regulations Physician Sunshine Act (open payments) HIPAA Standards of Care Standards of care arises from: National and state Written standards Licensure Accreditation Institutional Written protocols, guidelines, recommendations, appropriateness criteria Hospital Organization, e.g., ACR Appropriateness Criteria Guidelines Clearinghouse 12

13 Failing to Meet Standard of Care Failure to diagnose: leading cause of action (~75%) detection (missed) interpretation (misinterpretation) Delay in diagnosis: communication of results to referring physicians/patients failure to recommend appropriate follow up Procedural complications: most common complication is vascular injury during angiography and other interventional procedures Failing to Meet Standard of Care Implementation errors & complications: Contrast media: ionic vs nonionic Punctures & placement & biopsies Sedation Radiation exposure 13

14 Standard of Care Communication ACR, literature, and legal cases suggest that there is a duty to directly communicate findings: Findings suggest immediate medical intervention Findings suggest condition likely to worsen over time Findings unclear; follow up required Findings differ from a previous interpretation Chaperones From the standpoint of ethics and prudence, the protocol of having chaperones available on a consistent basis for patient examinations is recommended. AMA 1. Patients should be provided with chaperones if they ask. 2. Appropriate gowns & draping 3. Private facilities for disrobing ***Any time you touch a patient for an exam/procedure EXPLAIN CLEARLY 14

15 Online Modules in Ethics and Professionalism. American Board of Radiology Foundation Professionalism_.aspx. Available for continuing medical education credits by the: American Association Physicists in Medicine American College of Radiology American Society for Radiation Oncology Radiological Society North America 15

16 Licensing license to practice medicine revoked suspended restricted limitations other disciplinary action in another jurisdiction OPPE FPPE 16

17 17

18 HIPAA Sec : HITECH Office of Civil Rights (OCR) HIPAA penalties increased $11, adjusted for inflation Civil & criminal prosecution DOJ Ongoing audits Breach notification requirement https://ocrnotifications.hhs.gov/ HIPAA The final rule has a direct impact on BAs of covered entities, including subcontractors in the definition of business associate, and making both directly liable for compliance with specified rules of HIPAA. By implication: cloud storage and off site storage of PHI must be HIPAA compliant increasing direct costs to business practices for training and compliance measures. 18

19 HIPAA Genetic PHI protected from insurers in particular Sale of PHI for marketing addressed Datasets for research, Human Subjects Research Electronic records to patients, not paper Accessibility for children s immunization records, records of decedents HIPAA Enforcement Data breach results in $4.8 million HIPAA settlements Two health care organizations have agreed to settle charges that they potentially violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules by failing to secure thousands of patients electronic protected health information (ephi) held on their network. The monetary payments of $4,800,000 include the largest HIPAA settlement to date. The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) initiated its investigation of New York and Presbyterian Hospital (NYP) and Columbia University (CU) following their submission of a joint breach report, dated September 27, 2010, regarding the disclosure of the ephi of 6,800 individuals, including patient status, vital signs, medications, and laboratory results. NYP and CU are separate covered entities that participate in a joint arrangement in which CU faculty members serve as attending physicians at NYP. The entities generally refer to their affiliation as New York Presbyterian Hospital/Columbia University Medical Center. NYP and CU operate a shared data network and a shared network firewall that is administered by employees of both entities. The shared network links to NYP patient information systems containing ephi. The investigation revealed that the breach was caused when a physician employed by CU who developed applications for both NYP and CU attempted to deactivate a personally-owned computer server on the network containing NYP patient ephi. Because of a lack of technical safeguards, deactivation of the server resulted in ephi being accessible on internet search engines. The entities learned of the breach after receiving a complaint by an individual who found the ephi of the individual s deceased partner, a former patient of NYP, on the internet. 19

20 Institute of Medicine (IOM) The IOM defines a conflict of interest (COI) as a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. 20

21 The Stark Law Amendments The Stark law prohibits physician from making designated health service (DHS) referrals to organizations with which those physicians (or an immediate family member) have a financial relationship, unless an exception under the law applies. Section 6001: physician owned hospitals now severely restricted; eliminates development of new physician owned hospitals. Sec Disclosure requirements for in office ancillary services exception to the prohibition on physician self referral for certain imaging services. Additional requirement to the Medicare in office ancillary exception: requires the referring physician to inform the patient in writing that the patient may obtain the referred services from a person other than the referring physician, other than a physician who is a member of the same group practice as the referring physician, or an individual who is directly supervised by the physician or by another physician; provide the patient with a written list of suppliers who furnish these services in the area in which the patient resides 21

22 Do you have a proprietary interest in the technology or research about which you are speaking? MRI Sec. 1128G. Transparency Reports and Reporting of Physician Ownership or Investment Interests. Sunshine Provisions of PPACA Payments or transfers of value to physicians and covered recipients (teaching hospitals) by manufacturers and distributors of pharmaceuticals, medical devices, biological and medical supply products. Amends Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. 22

23 Check on your physician? for docs 23

24 Oncgoing Controversy 24

25 IOM: Clinical Guidelines We Can Trust (March 2011) Standards for developing trustworthy clinical guidelines. Emphasis on COI. Levels of Evidence* Level Study Design 1 Randomized Control Trial 2 Cohort Study 3 Case-Control Study 4 Case Series 5 Expert Opinion *systematic and meta-analysis reviews 25

26 Use of 2 x 2 Tables for PPV, NPV, TP, FP, FN Sensitivity Proportion of individuals who have disease and test positive for it. Number of TP who test positive divided by (TP+FP) Most useful for ruling out disease if you have a negative result Good screening tests have high sensitivity Have low Type II errors Specificity Proportion of individuals who so not have disease and test negative for it. Number of TN who test minus divided by (TN+FN) Most useful for ruling in disease if you have a positive result Good confirmatory tests have high sensitivity Have low Type I errors 26

27 Other things being equal, evidence-based medicine (EBM) has established a ranking of levels of evidence based on study design. Which one of the following statements about the relative strengths of these levels of evidence is TRUE? A. Case-control studies are considered stronger than cohort studies. B. Expert opinion is considered stronger than case-control studies. C. Case series are considered stronger than case-control studies. D. Randomized controlled trials are considered stronger than cohort studies. E. Expert opinion is considered stronger than a case series. Other things being equal, evidence-based medicine (EBM) has established a ranking of levels of evidence based on study design. Which one of the following statements about the relative strengths of these levels of evidence is TRUE? A. Case-control studies are considered stronger than cohort studies. B. Expert opinion is considered stronger than case-control studies. C. Case series are considered stronger than case-control studies. D. Randomized controlled trials are considered stronger than cohort studies. E. Expert opinion is considered stronger than a case series. 27

28 Confounding can occur when two groups being compared differ with respect to some factor associated with the outcome. Which one of the following approaches best minimizes the effect of all types of potential confounding? A. Stratifying the subjects on the basis of potential confounders. B. Adjusting for potential confounders with regression analysis. C. Matching subjects on the basis of potential confounders. D. Careful allocation of subjects by experienced investigators. E. Randomly assigning subjects to each of the groups. Confounding can occur when two groups being compared differ with respect to some factor associated with the outcome. Which one of the following approaches best minimizes the effect of all types of potential confounding? A. Stratifying the subjects on the basis of potential confounders. B. Adjusting for potential confounders with regression analysis. C. Matching subjects on the basis of potential confounders. D. Careful allocation of subjects by experienced investigators. E. Randomly assigning subjects to each of the groups. 28

29 Receiver Operating Characteristic (ROC) analysis techniques are often applied to studies of medical decision-making, especially in studies evaluating the impact of imaging technology on diagnostic accuracy. The theoretical framework underlying ROC analysis is best described by which of the following? A. How people encode, store, and retrieve information. B. How people make dichotomous decisions under conditions of uncertainty. C. How people identify objects, make decisions regarding their similarity, and make preference judgments. D. How people make current decisions based on the outcome of previous decisions. E. How people reduce the inherent uncertainty in information when they transmit it. Receiver Operating Characteristic (ROC) analysis techniques are often applied to studies of medical decision-making, especially in studies evaluating the impact of imaging technology on diagnostic accuracy. The theoretical framework underlying ROC analysis is best described by which of the following? A. How people encode, store, and retrieve information. B. How people make dichotomous decisions under conditions of uncertainty. C. How people identify objects, make decisions regarding their similarity, and make preference judgments. D. How people make current decisions based on the outcome of previous decisions. E. How people reduce the inherent uncertainty in information when they transmit it. 29

30 Errors in Diagnostic Radiology (U.S.) Diagnostic errors most often result from a combination of: cognitive + system errors National: ~30% (retrospectively), real-time daily mean 3-5%. E.g., preliminary reports by residents that are revised in a final report but not fully communicated to other providers; curb-side consults System Factors Contributing to Error in Diagnostic Radiology cost containment efforts turn around time goals increased workload decreased personnel fatigue 30

31 31

32 Cognitive errors Failure to perceive (missed) Interpretation of perception is incorrect (misinterpret) Cause: errors of visual perception include scanning recognition interpretation Cognitive Biases anchoring framing satisfaction of search premature closure confirmatory multiple alternative biases 32

33 Cognitive Errors Resulting from: Increased perceptual errors Performance errors Fatigue <reaction time Burn out Recommendations: reduce time in front of screen get up and walk hour Work Environment/design Errors, reduction in diagnostic efficacy, and fatigue occur as result of the work environment: Monitor Luminance Ambient Lighting e.g., office lighting is poor 33

34 moving Exercising and moving during long periods in front of monitors. Adjustable workstation height. PACS workstations use liquid crystal display (LCD) panels which offer excellent resolution without distortion. Flat panel surfaces can absorb ambient light to minimize reflection and glare. 34

35 Attributions The Core Examination Guide (ABR) Feb Bibliography and suggested reading The Non-interpretive Skills Guide (ABR) 2014 ACR: Appropriateness Criteria Practice Parameters & Technical Standards NGC: HHS: Health and Human Services AHRQ: Agency for Healthcare Research and Quality CMS: Centers for Medicare and Medicaid IOM: Institute of Medicine Thank you. If you have any questions please contact me: 35

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