Impact of Electronics in the Healthcare Setting Susan L. Penney, JD David Robinowitz, MD Heidi Collins UCSF Medical Center The Train Has Left the Station Goal: Know & Manage the Risks, Benefits & Alternatives Of the E-World Overview • Unexpected photos videos • Posting about work environment, patient care • Disease Management Sites • Patient Portals • E-mailing with Patients • Documentation • E-Discovery • Privileged Communications on the Internet • Posting Test Results • Medical Record Amendments • E-Consultations • Texting Risks 3 Do you have a Social Media Site? • Hospital or medical group social media hosted sites—you are asking patients to comment on your business? • What happens if a patient posts an unflattering review? 4 Websites—the good and the bad • Websites used for marketing, but you want to be careful of false advertising • Watch out for advertisements with endorsements • Disclaimers on websites are really important • Transparency of Quality Data: Joint Commission and litigation use Websites and the ADA-evolving rules • Access by blind, deaf or patients with manual dexterity limitations • ADA Title III: must provide auxiliary aids and services necessary to ensure equal access—this includes electronic and information technology • 2010 Statement confirms that websites that provide goods and services must be accessible http://www.reginfo.gov/public/do/eAgendaViewRu le?pubId=201210&RIN=1190-AA61 Patients filming and posting on YouTube Joe has quite a few psycho-social issues He has gone to many public official locations and filmed individuals to further his opinion that the world is a corrupt place He comes into a hospital’s outpatient clinic and begins to film your staff –he isn’t even a patient He then posts the films on YouTube and makes derogatory comments What do you do? 7 Filming • It is illegal to film or record an image or voice without permission • Penal Code section 632; • Civil Code section 3344 • Make it clear in your photography policy • Educate staff and physicians • Terms and Conditions/patients’ rights and responsibilities can reiterate this 8 Removal of posting Social Media Sites • Most sites have a privacy complaint process e.g. YouTube www.youtube.com/t/privacy_guidelines • Person whose image is inappropriately posted usually must make the complaint—eg. They usually require that the image allows others to recognize you • Cease and Desist letters can mirror the language of the site’s privacy policy Responding to Negative comments • Privately respond and address concern and ask them to remove—but opinion may not be removable • Counter act with positive stories, But don’t: • Have patients sign agreements not to post • Make up positive fiction • Respond with PHI to explain • Attack the poster 10 Employment Issues • Employee made a request from his manager • Confidential discussion between manager and employee • Employee dissatisfied with the manager’s response • Employee goes to the Facebook page and trashes the manager-mentions the facility • Question: Can anything be done about the employee’s behavior? • Freedom speech? • Slander/libel? • Institutional reputation? Discussing Work Activity • TJC survey is on-going • Surveyor comes to a nursing unit • Nurse gets on Facebook after surveyor visit • Discusses other nurses’ performance • Opines on probability of re-accreditation issues • Identifies patient room number • What do you do? Balancing: Employees’ Rights: •Speech •Organizing •Privacy With… Employers’ Rights •Reputation •Privacy •Patient Safety Employment activity • NLRB has issued advice memos related to social media policies http://www.nlrb.gov/newsoutreach/fact-sheets/nlrb-and-social-media • Employees cannot say anything they want: Not protected includes: • Disparagement of company’s or competitors’ products, services, executive leadership, employees, strategy and business prospects Expectation of Privacy? • Billy has had several workers comp claims but there is something fishy going on • One of Billy’s co-employees shows Billy’s manager some Facebook posts showing Billy demonstrating extraordinary physical abilities • The posts are used to deny the workers comp claim • Is this ok? Multi-Tasking? • Everyone said that the sponge count was correct, but the day after surgery, one was identified. • Nurses said they followed the policy but felt rushed to do the count • In a subsequent investigation/litigation, attorneys identify nurse’s Facebook post made during the surgery…..oops Ethical issues of Social Media story telling Health care providers often share clinical stories on social media: •To reflect a meaningful experience •Reach out for social support The problem with this practice: •Undermines the public trust in the profession •Inadvertently identifies patients •Violates expectations of privacy even if it doesn’t ID the patient* * University of Washington study “Sounding off on Social media” Your Policy: Reasonable terms • Facility sponsored blogs or social media must be approved to ensure: • Compliance with Privacy rules • That content is appropriate • Use of facility name and logo is appropriate • Consent rules must be followed • Assert that facility has the right to suspend blog activity if deemed inappropriate • For sponsored sites, require notification if knowledge of privacy breach Friending Patients • Develop Guidelines on Social Media http://www.ucsf.edu/about/social-media-guidelines • Risk recommends that you maintain clear separation between personal and professional life • Advise patients that you have a policy of not friending patients and stick to it. • Remember, if your “friend” a patient, if will likely impact other providers because they will get “friend” requests • In general, be very careful about sharing personal information with patients 19 Reasonable Policy Terms • For institutional sponsored social media: prohibit referrals or product endorsements • Indemnification agreements for violations of law Don’t forget the obligation for training and policies related to privacy!! Web Based Disease Management, Advice Lines and Chat Rooms • Often designed to increase referrals • Need to consider • Telemedicine rules • Privacy Rules • Rules of use, consider • Reserve the right to censor, remove or ban for • Sexual conversation, racial animus, glorification of addiction, politics, software piracy, religious discussion or disrespectful discussion 21 Blogs where health conditions are discussed Make sure to include a disclaimer related to medical advice • “We hope that the information obtained on this site will help you to be better able to participate with your health care providers in making informed decisions about your care. It is not a substitute for appropriate professional medical treatment or diagnosis. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this site. Except where explicitly stated otherwise, it is not intended as specific medical advice. Neither the institution nor its officers, agents or employees assume any legal liability or responsibility for the accuracy, completeness or usefulness of any information, apparatus, product or medical procedure described.” Internet research to make healthcare decisions • Research varies widely on patient demographics of internet research: 1/3 to 85% • Even if patients use the web, the vast majority base health decisions primarily on the information provided by their physicians • There is inconclusive data on what happens when the patient brings internet data to the attention of their provider Internet Research—why are patients doing it? • They don’t want to bother the doctor • More information on the internet than they have time to discuss with their physician • They want to show the physician that they have invested time in their medical concern and want to be taken seriously • They are distrustful of their physician (not the primary reason) Patients report a wide range of responses from providers* • Listening and acknowledgment • Non-verbal cues that they are “checking out” • Disregard or fail to acknowledge a lack of knowledge • Accusatory behavior or a patriarchal or threatened response *I need her to the a doctor: British Journal of General Practice November 2012 Patient Portals in your EHR • Create expectations for response time to patients/ limitations of use—not for an urgent or emergent issue • Have good “terms of use” so that it is clear how the portal is to be used • It can be a very efficient way to communicate • Set rules up for discontinuation from use of portal if abuse • Providers are spending more time than ever before responding to patients at all hours of the day/night • Kaiser says physicians on average receive 5 emails a day—is that your experience? E-mailing with Patients • Some institutions have changed by-laws to prohibit using e-mail and allow electronic communication via patient portal only • If you don’t use e-mail: • Reference it in the terms and conditions of admission • Develop an auto message that states your policy on how the patient should reach you • Make sure the patient has an alternative efficient method of communication • PROBLEM: A GOAL OF CONSISTENCY AS BETWEEN PROVIDERS IS UNREALISTIC • WE ARE ALL DRIVEN BY PATIENT DEMAND & SATISFACTION: • “Marketing and listening to your customer should be good enough reason {to use e-mail}” says a consultant 27 E-mailing with Patients • If you do use e-mail: • Consider a consent form • Don’t attempt to obtain a “waiver of HIPAA” ---it won’t work • Move toward a secure e-mail system—internet providers do not guarantee security but patients may not realize that • This triggers the need for an IT Security plan to develop filters so that personal health information (phi) does not leave the organization • If you are using personal e-mail for substantive e-mail exchange, you need a system for transferring that information to the EHR or the paper medical record—how do you monitor compliance? (that is why e-mail is not typically included in the definition of legal health record) • Consider appropriate management by Allied health providers within their scope of practice---set rules!! And Watch for Scope Creep • Control what you accept from patients via e-mail—external records 28 Benefits of e-mail • Prescription refill requests for certain medications--watch your nurses/MA’s scope of practice • Appointment reminders • Billing • Administrative matters • Patient education notification—web based • Can eliminate phone tag and/or reduce calls • Can provide documentation if within or transferred to medical record 29 Benefits of e-mail • Some studies say it improves quality measures • Continuity of Care • Patient-physician connectedness • Supporting patient self-management • Patient loyalty • Getting Paid: • The world of reasonable reimbursement will have to catch up to allow physicians to be paid for the value added and advice. 30 Risks of e-mailing patients • Use of personal versus professional e-mail • Storage and backup of e-mail • Tracking of e-mail and e-mailing during work hours • Appropriate use—not for urgent medical advice • See AMA Guidelines for Physician-Patient Electronic Communication http://hosted.ap.org/specials/interactives/_docum ents/patient_physician_email.pdf Well intended but risky use of e-mail to give clinical advice • 55 year old patient seen in a sports medicine clinic for hip pain—under went hip surgery • Prior to surgery, patient had an EKG reported as “abnormal record, marked sinus bradycardia” • 3 months after surgery, patient contacts the surgeon complaining of chest pain while exercising • The doctor was on vacation, but believes he called the patient (no documentation) • Ordered EKG—otherwise normal EKG, sinus bradycardia • Patient e-mailed with more pain—no response • Patient died from heart failure 3 days later 32 Issues • Is there an on-call system within the physician’s practice? • Does the physician have an auto response when on vacation to manage patient’s expectations? • None of the e-mail or communication was documented in the patient’s medical record • E-mail used was the physician’s personal e-mail • E-mail gets deleted, e-mail services change, which reduces the ability to locate e-mail to defend the case 33 E-Discovery • Litigation involves a phase called Discovery • Typical topics of discovery: medical records; policies and procedures • California and Federal law now require ediscovery—the production of: • Texts • E-mails • Instant messages • Telephone messages • Strong penalties for failure to comply 34 E-Discovery Issues • Who has control over your electronic communications? • Individual physicians are responsible but who controls their e-mails? • When is the obligation to retain electronic data triggered? Adverse Event? Notice of Intent? • Will need a process for “litigation holds” • Will need IT specialists or consultants who can retrieve the data • Can you assert a privilege related to any of these communications? 35 Declarations Against Interest • Patient undergoes a high risk heroic surgery for a brain tumor—surgery is a success • Patient develops a Surgical Site Infection with a rare bug and has a significant set back • The plaintiff alleges that the surgeon made all sorts of statements about the cause of the infection and the treatment for the infection • The surgeon routinely communicated via e-mail with the patient’s family • Over 500 e-mails were retrieved from the surgeon’s e-mail alone...what do they say? 36 Communication re Quality Reviews • Evidence Code section 1157 allows for the confidentiality of the activities of medical staff committees related to quality and patient safety activity • Committee activity has evolved to include e-mail communication and follow-up • Update policies as to what constitutes the activities of these committees • Properly label the e-mail communications to identify 1157 Activity • Assert the privilege 37 Other Risks and Benefits • Auto release of test results—unintended consequences • Patients’ misinterpretation of test results • Radiology results—are radiologists ready to receive calls from patients? • Providers lulled into false sense of security that patient has seen the results, resulting in the risk that: • The physician will not review and act on results • Follow up may not occur • Providers who do not check their message inbasket—same problem, new system • Managing in-basket with a pool—manage carefully! Other Risks and Benefits • Sharing the problem list with patients • Increased requests for medical record amendments • Make sure your providers know the rules • Alcohol and substance use—will a patient ever agree? • Does the patient see the diagnosis of • Schizophrenia or Munchausen by Proxy? The Problem with Problem Lists • Many web based patient portals allow patients to view their problem lists • We have seen a dramatic increase in patient requests for medical record amendments 40 The Merchant Marine Applicant • Patient presents to the GI clinic and a history is taken by a resident • The history includes the patient’s report that he smokes marijuana • Subsequent to the visit, the patient applies to be a merchant marine—records are sent • The patient sees on his problem list the use of marijuana and wants the record changed • The physician amended the record because of the plaintiff’s pressure that he would be denied by Merchant Marines 41 Amendments and Addendums to the Medical Record • The use of a patient portal and the patient’s ability to see his or her problem list or history should not change your policy on when medical record amendments should be made • Changes should be made if there was an error, not because the patient disagrees with the note • Difficult to manage for sensitive diagnoses • Physicians would benefit from education/support in managing these requests. 42 Texting • Studies are showing that providers are texting during surgery or other work activity • And the new generation thinks that texting is a nifty way to send orders? • Joint Commission standards prohibit texting of orders http://www.jointcommission.org/standards_infor mation/jcfaqdetails.aspx?standardsFAQid=401& StandardsFAQChapterd=79 Joint Commission FAQ’s • Texting Orders New | November 10, 2011 • Is it acceptable for physicians and licensed independent practitioners (and other practitioners allowed to write orders) to text orders for patients to the hospital or other healthcare setting? • No it is not acceptable for physicians or licensed independent practitioners to text orders for patients to the hospital or other healthcare setting. This method provides no ability to verify the identity of the person sending the text and there is no way to keep the original message as validation of what is entered into the medical record. Texting Risks--15 Year Old Neurosurgery Patient • 15 year old underwent spine surgery • On the unit, issue as to whether there should be neuro checks q 4 hours. • Post-op orders were confusing • Post-op, a resident attempted a hand-off to another resident by sending a text instructing them to do a post-op exam • The resident did not confirm receipt of the text, sent it to a device not working and no post op exam was done • The following morning the patient was found to be paraplegic Texting and other electronic communication • Develop clear guidelines on what constitutes a hand off • Mandate confirmation of receipt of communication • Develop rules of accountability • Develop rules of supervision 46 Limit your risk related to Texting because you can’t stop it • No personal health information • Workforce training—especially your young staff and trainees • Encrypt and password protect • Require note in medical record when information received by text influences a medical decision Conclusion • The Web has changed the world and there is no going back • Patient demand is important, but avoid the response “if the patient wants it, we must do it” • Manage the issue with • policy • training • quality reviews • Rules of the road • Consent 48 The Best of all Worlds Enterprise Risk Management for the E-world IT, Clinical Users & Medical Records Dept Regulatory, Compliance & Legal Privacy & Operations Planning requires the willingness to understand stakeholders’ points of view Risk Management & Defense Counsel Finance & Strategic Planning What is Standard of Care Related to EHR? • EHR systems can allow unlimited scanning of outside records • Some hospitals for particular referral programs are allowed access to another facility’s record for a patient. E.g. transplant • “Care Everywhere” allows Emergency Departments immediate access to records from other facilities but… What is the standard for accountability for knowing or acting on shared information? Suggestion: when drafting agreements and consent forms include disclaimer that review of record will depend upon patient’s condition and urgency of care The Anesthetic Record What is the purpose of the anesthetic record? “The goal of the anesthetic record is to capture a patient’s response to anesthesia and surgery by recording the procedures, physiologic changes, key events, and pharmacologic administration that occur throughout the perioperative period.” 1 1. Kadry, B., Feaster, W. W., Macario, A. & Ehrenfeld, J. M. Anesthesia information management systems: past, present, and future of anesthesia records. Mt Sinai J Med 79, 154-165 (2012). Limitations of Paper Records1 • Recall Bias • Data analysis requires manual chart review • Illegible (or impressionistic) records • Lost/missing records • Incomplete data – issues with documentation of compliance and billing requirements • Handwritten records may have less medicolegal “heft” (no audit trail) 1. Kadry, B., Feaster, W. W., Macario, A. & Ehrenfeld, J. M. Anesthesia information management systems: past, present, and future of anesthesia records. Mt Sinai J Med 79, 154-165 (2012). History of AIMS • First AIMS was mechanical device (E. I. McKesson 1930’s) to record 1. Featherstone, R. J., Adams, C. N. & Bacon, D. R. Physiological monitoring and record-keeping in anaesthesia - an unrecorded contribution. American Society of Anesthesiologists (2012). History of AIMS • 1950’s – 1990’s development of automated anesthesia record keepers (AARKs) – Limited by availability of sophisticated, inexpensive, and reliable hardware and software1 – Pioneering Systems2 • DAME (Duke Anesthesia Monitoring Equipment) – A few ORs at Duke • ARKIVE (Anesthesia Record Keeper Integrating Voice Recognition) – Installed at Vero Beach, Duke, and Fitchburg • 1990’s – slow rollout of commercial products 1. 2. Shah, N. J., Tremper, K. K. & Kheterpal, S. Anatomy of an anesthesia information management system. Anesthesiol Clin 29, 355-365 (2011). Stonemetz, J. Anesthesia information management systems marketplace and current vendors. Anesthesiol Clin 29, 367-375 (2011). AIMS – Adoption Challenges • Usability – Concerns of decreased productivity – Technology Adoption Model • System will be used against me1 • Return on Investment – ~$25,000 per anesthetic location 1. 2. Stonemetz, J. Anesthesia information management systems marketplace and current vendors. Anesthesiol Clin 29, 367-375 (2011). Vigoda, M. M., Rothman, B. & Green, J. A. Shortcomings and challenges of information system adoption. Anesthesiol Clin 29, 397-412 (2011). AIMS Prevalence: 20071 ~ 44% of US Academic Medical Centers had implemented an AIMS or were in process… 1. Egger Halbeis, C. B., Epstein, R. H., Macario, A., Pearl, R. G. & Grunwald, Z. Adoption of anesthesia information management systems by academic departments in the United States. Anesth Analg 107, 1323-1329 (2008). AIMS Prevalence: 2013 & Beyond1 Survey of US Academic medical centers • By 2014, approximately 75% will have AIMS installed • Logistic regression predicts that 84% will have AIMS by 2018-2020 • Academic medical centers are outpacing private practices • It is possible that within a few years, trainees will graduate from anesthesia residencies never having used a paper record. 1. Stol, I. S., Ehrenfeld, J. M. & Epstein, R. H. Technology diffusion of anesthesia information management systems into academic anesthesia departments in the United States. Anesth Analg 118, 644-650 (2014). Benefits of AIMS Improved Quality of Care? Anesthesiologists can focus on higher level tasks in lieu of charting data vs. Loss of vigilance or situational awareness AIMS and Situational Awareness The act of recording information on the chart forces the anesthesiologist to be aware of the time course and detail of anesthetic events. This awareness is the most important factor in anticipating future events, and correcting untoward events. A mechanically created record … has the capacity to be formed without ever passing through the consciousness of the anesthesiologist… The effort to create automated anesthetic records, while interesting technical exercises, are dangerous, because they bypass the anesthesiologist, making it easier for essential information to go unrecognized. - Theodore Noel, 1986 1. Noel, T. A. Computerized anesthesia records may be dangerous. Anesthesiology 64(2), 300 (1986). Deeper limitation of graphical paper records (and AARK): What’s the story? • Both traditional written anesthesia record and the AARK have been criticized as poor vehicles for telling the story of an anesthetic. “The current anesthesia record whether handwritten, or automatic, is mindless.”1 Answered in part by “Case Summary Note” and ongoing free text notes in which commentary and narrative can be stored? Or increased sophistication of meta-data? (more later) 1. Zeitlin, G. L. History of anesthesia records. ASA Newsletter APSF 25th Anniversary Edition, 26-29 (2011). AIMS and Clinical Practice Task Analysis: Manual Recording • Analysis of 3 CABG cases in a teaching hospital, 1976 • 10-15% of time spent “logging data on anesthetic record.” • Recommended adoption of electronic system to record data automatically 1. Kennedy, P. J., Feingold, A., Wiener, E. L. & Hosek, R. S. Analysis of tasks and human factors in anesthesia for coronary-artery bypass. Anesth Analg 55, 374-377 (1976). AIMS and Clinical Practice Task Analysis: Manual Recording • UCSD 1994 task analysis, workload, and vigilance study – 11 GETA cases by new junior residents vs. 11 GETA cases by senior residents and experienced CRNAs • Pre-intubation 0.9 vs. 0.4 mins mean time spent on recording • Post-intubation 13.9 vs. 9.4 mins 1. Weinger, M. B. et al. An objective methodology for task analysis and workload assessment in anesthesia providers. Anesthesiology 80, 77-92 (1994). AIMS and Clinical Practice Task Analysis: Manual Recording 1. Weinger, M. B. et al. An objective methodology for task analysis and workload assessment in anesthesia providers. Anesthesiology 80, 77-92 (1994). 63 AIMS and Clinical Practice Vigilance: Electronic vs. Manual Recording • Is writing in the paper record necessary or beneficial for anesthesia provider vigilance? – 1995 UC Davis Study1 of anesthesia residents • Manual recording vs. human scribe/assistant • 36 GA outpatient cases, ASA 1 and 2 • Vigilance assessed by detection rate and response time to simulated abnormal value on monitor • Similar response rates and times for both groups 1. Loeb, R. G. Manual record keeping is not necessary for anesthesia vigilance. J Clin Monit 11, 9-13 (1995). AIMS and Clinical Practice Vigilance: Electronic vs. Manual Recording 1. Loeb, R. G. Manual record keeping is not necessary for anesthesia vigilance. J Clin Monit 11, 9-13 (1995). 65 AIMS and Clinical Practice Vigilance: Electronic vs. Manual Recording • Woods and Cognitive Science colleagues at The Ohio State University criticism of the UC Davis study1 – The automation simulator – the human scribe – “functioned as a team player: responsive, directable, intelligent, nonintrusive” – In contrast, automated systems are typically not team players when they are • Strong (act autonomously) • Silent (provide poor feedback) • Clumsy (interrupt human teammates during high workload or critical periods; or add mental burdens during these periods) • Difficult to direct (costly for human to instruct the automatic system re: how to change as circumstances change) 1. Woods, D. D., Cook, R. I. & Billings, C. E. The impact of technology on physician cognition and performance. J Clin Monit 11, 58 (1995). AIMS and Clinical Practice Task Analysis, Workload, Vigilance: Electronic vs. Manual Recording • 1997 Study of senior residents providing anesthesia for 20 CABG cases1 – Randomized to an actual automated system – an electronic anesthesia record keeper (EARK) or manual recording – Two groups had similar task distributions by task analysis – EARK group spent slightly less time record keeping after intubation and before bypass (more time observing monitors and talking with attending) – No significant differences between two groups in self reported workload scores, workload density (weighted scores of tasks/minute), or vigilance latency (measured as response time to randomly activated light) – (Only 4/20 cases had any record keeping prior to intubation) “charting comes last” 1. Weinger, M. B., Herndon, O. W. & Gaba, D. M. The effect of electronic record keeping and transesophageal echocardiography on task distribution, workload, and vigilance during cardiac anesthesia. Anesthesiology 87, 144-55; discussion 29A (1997). Motivation for AIMS1 • Automated anesthesia record keeper (AARK) is only one component of an AIMS – AIMS also includes metadata not necessarily captured by an AARK • Case events (e.g. in-room, cross-clamp-on) • Medication administration – A full AIMS is an AARK interfaced with numerous systems such as • Pharmacy • Admit/Discharge/Transfer systems • Laboratory • Billing • Perioperative Scheduling 1. Kadry, B., Feaster, W. W., Macario, A. & Ehrenfeld, J. M. Anesthesia information management systems: past, present, and future of anesthesia records. Mt Sinai J Med 79, 154-165 (2012). One word of caution • Not all AIMS are created equal – – – – – – Different vendors/products Different configurations Different hardware Different workflows Different case mixes Different cultures • Design matters! Interpret literature in this context AIMS will impact care processes, but alone cannot fix all problems AIMS wanted for more than record keeping… Motivations to adopt AIMS:1 the Black Box • Quality/Safety group endorsements – APSF (2001): “… endorses and advocates the use of automated record keeping in the perioperative period and the subsequent retrieval and analysis of the data to improve patient safety.”2 – Analyze incidents and outcomes data •Demonstrate compliance1 •Streamline billing processes1 1. 2. Stonemetz, J. & Lagasse, R. Rationale for purchasing an AIMS, in Anesthesia informatics (eds Stonemetz, J. & Ruskin, K.) 7-22 (Springer-Verlag London Limited, 2008). APSF Board of Directors. American Society of Anesthesiologist Annual Meeting (New Orleans), 2001, Board of Directors Motion. APSF Newsletter Winter, 2001. AIMS as AARK Straightforward AARK serves as clinical tool •Decreases charting burden • Allows the anesthesiologist to “face the field” and have greater immediate situational awareness Has this fundamental goal been overwhelmed by the use of AIMS for research, compliance, billing, and other purposes? AIMS – Here to Stay Who wants (or demands) anesthesia/peri-op data? • SCIP (CMS, CDC) • • • • • • • • • NSQIP The Joint Commission PQRS APSF MOCA P4P Private Insurance Third party payers Research and Quality Consortia/Registries Who else? • Your medical center, department, colleagues • Consumers/potential patients • ACGME And don’t forget • Benefits of Meaningful use1 – Non-hospital based anesthesiologists – if EHR by 2015 up to $44,000$63,750; after 2015 avoid payment reduction – Or, support hospital meaningful use and share in benefit? 1. Lai, M. & Kheterpal, S. Creating a real return-oninvestment for information system implementation: life after HITECH. Anesthesiol Clin 29, 413-438 (2011). AIMS – Here to Stay Who wants (or demands) anesthesia/peri-op data? • SCIP (CMS, CDC) • • • • • • • • • NSQIP The Joint Commission PQRS APSF MOCA P4P Private Insurance Third party payers Research and Quality Consortia/Registries Who else? • Your medical center, department, colleagues • Consumers/potential patients • ACGME And don’t forget • Benefits of Meaningful use1 Medical Center Lawyers – Non-hospital based anesthesiologists – if EHR by 2015 up to $44,000$63,750; after 2015 avoid payment reduction – Or, support hospital meaningful use and share in benefit? 1. Lai, M. & Kheterpal, S. Creating a real return-oninvestment for information system implementation: life after HITECH. Anesthesiol Clin 29, 413-438 (2011). The Wing Leveler vs. The 787 1. 2. 3. Popular mechanics http://www.39pw.us/web/icons/autopilot.jpg accessed 12-March-14 http://en.wikipedia.org/wiki/File:Boeing_787-8_N787BA_cockpit.jpg by Alex Beltyukov, Creative Commons 74 The Wing Leveler vs. The 787 1. 2. 3. Popular mechanics http://www.39pw.us/web/icons/autopilot.jpg accessed 12-March-14 http://en.wikipedia.org/wiki/File:Boeing_787-8_N787BA_cockpit.jpg by Alex Beltyukov, Creative Commons Caveat 2: AIMS – Something for Everyone? Once there is an AIMS, many parties will have ideas of what it is: It’s •an AARK – decrease anesthesiologist reporting burden! •a compliance and liability reduction tool! •a data acquisition tool for my clinical research project! •an improved clinical record keeper to smooth transition to ICU care! AIMS – and Clinical Decision Support Table from Vakharia, S. B. & Rinehart, J. Using anesthesia AIMS data in quality management. Int Anesthesiol Clin 52, 42-52 (2014). AIMS – Clinical Decision Support • Alert Criteria Matter • Design Matters - See [1] for theory – Hard Stop • Human Factors Engineering – See [2] for overview – Modal Dialogue Box – Audible Alert – Icon – CDS on demand – Messaging – Photos3 1. 2. 3. Raymer, K. E., Bergstrom, J. & Nyce, J. M. Anaesthesia monitor alarms: a theory-driven approach. Ergonomics 55, 1487-1501 (2012). Weinger, M. B. & Gaba, D. M. Human factors engineering in patient safety. Anesthesiology 120, 801-806 (2014). Hyman, D., Laire, M., Redmond, D. & Kaplan, D. W. The use of patient pictures and verification screens to reduce computerized provider order entry errors. Pediatrics 130, e211-e219 (2012). AIMS – Clinical Decision Support An alarming issue…. •Excessive AIMS alerts may be analogous to excessive monitor alarms and could lead to alarm/alert fatigue. •A system for managing these alerts is recommended. See [1] for principles for alarm management 1. American Society of Anesthesiologists House of Delegates. Statement on principles for alarm management for anesthesia professionals. (2013). AIMS – and Clinical Decision Support - example University of Washington AIMS interface to near real time decision support engine1 •“Pop-Up” screen alerts for hypotension in context of high MAC and hypertension in context of ongoing phenylephrine infusion – – Reduced frequency and duration of hypotension-high MAC incidents Hypertension-phenylephrine frequency not changed but may have been affected by (retrospective) manual recording of phenylephrine infusion •Recommended incorporation of CDS into AIMS, rather than as “add-on” to increase data sampling frequency 1. Nair, B. G. et al. Anesthesia information management system-based near real-time decision support to manage intraoperative hypotension and hypertension. Anesth Analg 118, 206-214 (2014). AIMS – and Clinical Decision Support - example University of Michigan – AIMS alerting for patients with potential Acute Lung Injury (ALI) to promote low tidal volume ventilation strategy in OR1 • “Just in time” randomized controlled trial – Enrolled patients with PaO2/fiO2 < 300 – 60,960 patients analyzed; 100 total patients met criteria for inclusion (had blood gas, > 18 years old, height recorded in system; and ventilator data received in AIMS) – Intervention group received alert recommending Vt of 6 mm/kg of Predicted Body Weight 1. Blum, J. M. et al. Automated alerting – Control group received and recommendations for the conventional care with no alert management of patients with preexisting •Results: Vt/PBW: control group: 8 mm/kg vs.. intervention: 7.2 mm/kg hypoxia and potential acute lung injury: a pilot study. Anesthesiology 119, 295-302 (2013). AIMS and Risk/Liability • Background • Belief that AIMS could increase liability by • Capturing transient physiologic changes — of minimal clinical significance — that could be misinterpreted by consumers of the electronic record • Incorporating artifactual data • Or AIMS could reduce liability by • Providing a “more contemporaneous, complete, and legible rendition of actual events than the handwritten record.” 1. Feldman, J. M. Do anesthesia information systems increase malpractice exposure? Results of a survey. Anesth Analg 99, 840-3, table of contents (2004). AIMS and Risk/Liability • 2004 Survey: 22/55 Departments of Anesthesia1 Completely Responded • 41 malpractice cases – 30 dropped • In 5 of these, AIS helped “document absence of negligence” – 11 settlement or litigation • In 5 of these, AIS “facilitated decision to settle” • For litigation case: 2 instances of AIS assisting defense; no cases in which AIS hindered the defense • 18 respondents: AIS valuable for risk management • 2 respondents: AIS essential for risk management • Zero respondents believed AIS to be harmful for risk management. • 19/22 recommended use of AIS as part of risk management strategy 1. Feldman, J. M. Do anesthesia information systems increase malpractice exposure? Results of a survey. Anesth Analg 99, 840-3, table of contents (2004). AIMS and Risk/Liability Selected survey comments1 •“I know of 3 cases where the [automated] anesthesia record directly contributed to the anesthesiologist being dismissed (from the case).” •“We have few suits in part because we have an electronic anesthetic record.” •“Concern about artifacts is misplaced – they’re easy to spot.” 1. Feldman, J. M. Do anesthesia information systems increase malpractice exposure? Results of a survey. Anesth Analg 99, 840-3, table of contents (2004). AIMS and Risk/Liability • University of Miami case • 58 y/o patient underwent craniotomy and suffers postoperative quadriplegia. • Automated record keeping (PICIS (v 6.3)) • During the case, CRNA provided break, returned the AIMS to vitals signs screen, and noticed that device data were not being recorded. • Although IT/engineering fixed problem, missing data were not entered into the chart (and anesthesia attending was not notified). 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case1 • Claim filed • Investigation: 93 minutes of missing data, likely due to disconnected cable • Problems with anesthesia documentation contributed to decision to settle case 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case1 – Issue 1: Lack of awareness of incomplete record • Missing data that possibly could refute claim (or support it) • Challenged legitimacy of other items in record – Required to have every five minute charting 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case1 – Issue 1: Lack of awareness of incomplete record • Medication window could cover the vital signs display – Added an alert for missing data stream(s) – Post-case review of chart data integrity • Natural anesthesiologist’s scan did not include AIMS screen – Re-mounted AIMS display on left side of anesthesia machine, near vitals signs monitor 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case1 – Issue 1: Lack of awareness of incomplete record D E S I G N M AT T E R S • Medication window could cover the vital signs display – Added an alert for missing data stream(s) – Post-case review of chart data integrity • Natural anesthesiologist’s scan did not include AIMS screen – Re-mounted AIMS display on left side of anesthesia machine, near vitals signs monitor 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case1 – Issue 2: Timing of Chart Entries • Lack of concordance of blood pressure changes and notation of re-zeroing of art line at ear • “Pre-attestation” of presence at extubation by attending – Audit trail subpoenaed 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case1 – Issue 2: Timing of Chart Entries • Challenged practice: charting immediately with option to edit – Now documentation at end with option to change time, but never future charting 1. Vigoda, M. M. & Lubarsky, D. A. Failure to recognize loss of incoming data in an anesthesia record-keeping system may have increased medical liability. Anesth Analg 102, 1798-1802 (2006). AIMS and Risk/Liability • University of Miami case Follow-up effort1 – Present at emergence attestation – Automated feedback to discourage pre-attestation 1. Vigoda, M. M. & Lubarsky, D. A. The medicolegal importance of enhancing timeliness of documentation when using an anesthesia information system and the response to automated feedback in an academic practice. Anesth Analg 103, 131-6, table of contents (2006). AIMS and Risk/Liability • Automated information management system produced paper record with 15 minute resolution • During case, there was drop in EtCO2 associated with significant blood loss, but this was only apparent at resolution of 1 minute, not on printed summary. • Which is “official medical record?” 1. Green, J. A., Arancibia, C. U. & Colquhoun, A. D. Failure to display a significant change in etCO2 on printed automated anesthesia record: case report and medicolegal implications. Society for Technology in Anesthesia (2007). AIMS and Risk/Liability • Review of evidence as related to anesthetic records1 – E-discovery – Computer forensics – Audit Trails 1. Szalados, J. E. The legal implications of anesthesia record shortcomings. Anesthesiology News 33, (2007). AIMS and Risk/Liability • Discussion of U. of Miami Case1 – If anesthesiologist signed off on case, then there may have been a reasonable duty to review the record (since reviewing a record in PICIS is not burdensome) – Spoliation – intentional destruction, alteration, or hiding of evidence • May sometimes be presumed that party that lost the evidence did so intentionally to prevent harm to their side. 1. Szalados, J. E. The legal implications of anesthesia record shortcomings. Anesthesiology News 33, (2007). AIMS and Risk/Liability • Discussion of U. of Miami Case1 – Recommendations “medical records are expected to be accurate, legible and complete; the signing physician is expected to authenticate the record and vouch for its truthfulness; and the use of [an AIMS] does not necessarily absolve the signing physician of liability.” 1. Szalados, J. E. The legal implications of anesthesia record shortcomings. Anesthesiology News 33, (2007). AIMS and Risk/Liability • Discussion of STA abstract case1,2 – Official anesthetic record • Original data – where originally stored • Copies and Printouts – secondary data – If addendum, may cast doubt on record if multiple versions of records exist – Court may require original data 1. Green, J. A., Arancibia, C. U. & Colquhoun, A. D. Failure to display a significant change in etCO2 on printed automated anesthesia record: case report and medicolegal implications. Society for Technology in Anesthesia (2007). {cited in #2} 2. Szalados, J. E. The legal implications of anesthesia record shortcomings. Anesthesiology News 33, (2007). AIMS and Risk/Liability Reviewer’s advice re: STA Case1,2 [emphasis added] 1.“the official record is the data collected by the computer; the printed record is a legally acceptable summary that remains suspect pending analysis of the full electronic record” 2.The AIMS database contains the original data – it may have components that are not on the summary record, but they are still discoverable. Know what’s there 3.Corrections, deletions, addenda, etc. leave a digital trail that may undermine the credibility of your record 1. Green, J. A., Arancibia, C. U. & Colquhoun, A. D. Failure to display a significant change in etCO2 on printed automated anesthesia record: case report and medicolegal implications. Society for Technology in Anesthesia (2007). {cited in #2} 2. Szalados, J. E. The legal implications of anesthesia record shortcomings. Anesthesiology News 33, (2007). In Closing… 1. Design Matters – ensure missing data are obvious and can be corrected easily 2.Workload Matters – ensure amount of time needed to “feed” the system is at least less than time system saves clinicians (see #1) 3.A Major Benefit of an AIMS is using the information it generates to improve systems of care – ensure compliance groups have access to AIMS data “You can never have enough report writers!” 4.To use the system appropriately, providers must have adequate training, including a thorough understanding of the digital trail they leave behind.