Chad P. Brouillard, ESQ.

1. The Provider Handoff Chad P. Brouillard, ESQ. Thursday March 27, 2014 CPMA Hartford, CT

2. DISCLOSURE STATEMENT Chad Brouillard, Esq. has no financial relationships to disclose Chad Brouillard, Esq. is with Foster & Eldridge, LLP in Cambridge, MA.

3. Objectives • Recognize prevalent issues with EMR management which have resulted in medical malpractice losses • Understand legal ramifications of not using technology responsibly and effectively (case examples) • Discuss best practices for minimizing risk while using electronic health records

4. EHR- The Essentials EHR - comprehensive computerized health-care records in enterprise-wide systems EMR – same thing, except smaller scope EHR and EMR have been used interchangeably for years despite technical differences

5. EHR- The Essentials There are many different types of EHR Homegrown Purchased Custom made Hybrid paper/electronic Multi department record systems 700+ Vendors, over 6000 certified implementations.

6. New York Times March 11, 2009 “Wal-Mart Plans to Market Digital Health Records System” Wal-Mart Stores is striding into the market for electronic health records, seeking to bring the technology into the mainstream for physicians in small offices, where most of America’s doctors practice medicine.

7. Overview • The delivery of health care, whether in a hospital or a physician office, is a complex process that involves a large number of people. The importance of communication methods that provide accurate, timely and available information is underscored by the fact that communication failures have been identified in 80% of medical malpractice cases.

8. BENEFITS OF EHR ↑ Quality of care; ↑ Patient Safety; ↑ Operational efficiency; ↑ Bottom-line financial results.

9. Devil is in the details How are electronic records changing the landscape of medical malpractice cases?

10. Discovery • The process of discovery is the opportunity of litigants to uncover every stone. There are several different discovery vehicles: • Written questions (Ints & RFA); • Oral questions (Depositions); • Production of “documents”.

11. eDiscovery • With the implementation of EHR, eDiscovery adds a whole new element to traditional discovery. • eDiscovery refers to the rules governing the disclosure of electronic data, or ESI, contained within any possible electronic medium.

12. eDiscovery UPDATE The Supreme Judicial Court of Massachusetts has enacted formal eDiscovery rules into the laws governing civil cases. In effect as of January 1, 2014. Provides an effective vehicle for plaintiff’s attorney to seek electronic data in and outside your EHR. Imposes obligations on owners of information systems such as EHRs.

13. eDiscovery • What could be subject to eDiscovery: • Office computer; • Personal computers; • Smart phones; • Email; • Texts; • Websites; • Interactive patient sites.

14. eDiscovery • How is a the storage of information in a EMR different from a Paper Chart? • Remember the good old days: • The chart; • The office schedule; • A phone message record book; • The billing record; • If it didn’t exist, than don’t create it! (Memory and custom and practice prevailed!)

15. eDiscovery • With eDiscovery, the printed EHR is just the beginning….

16. eDiscovery • Audit Trails; • Metadata; • Data Exchanges; • Clinical decision support (Clinical pathways); • Pharmacy/Prescribing; • Remaining paper sources (i.e. handwritten sheets in radiology folders, writing on fetal monitoring strips.) (Can contradict EHR)

17. Discovery • In a legal case, what is the Plaintiff’s Attorney looking for….

18. eDiscovery • With eDiscovery the Smoking Gun very well may be invisible to the naked eye. • Metadata; • Audit trails.

19. Metadata/Audit Trail • The metadata and audit trails can include details about: • WHO created the record; • WHEN the record was created; • Whether the record was CHANGED; • WHEN the record was changed; • WHO accessed the record; • WHEN the record was accessed.

20. Metadata/Audit Trail • Why is the Audit trail important to you? • Can be utilized to call your competence or credibility into question. OR • Can be used to demonstrate timely and responsible record keeping and eliminate the specter of impropriety.

21. Search for the smoking gun • Example 1: A young patient of a PCP commits suicide. A malpractice suit is filed against the PCP. The claim is negligence. At the discovery stage, the plaintiff’s attorney requests the EMR and all audit trails. The plaintiff’s attorney tells us, she thinks the PCP altered her record. The doctor denies the allegation. • What did the audit trail reveal?

22. The Audit Trail- Timing of the Note • It revealed that the PCP created her note two months after the patient’s suicide. • Doctor speculated that someone else in the office could have accessed her note after its creation and accidentally altered the date. • Metadata revealed she was the only provider to access the chart.

23. The Audit Trail- Timing of the Note Without even reading the note content, how will the audit trail hurt the PCP?

24. The Audit Trail- Timing of the Note • The physician is cast as: • Not conscientious or not diligent; • Uncaring; • Lazy; • Too busy; • Guilty; • Unbelievable.

25. Smoking Gun • As to the content of the note itself, plaintiff’s counsel will attack its reliability because note not prepared contemporaneously. • How accurate could it be 2 months later? • Also, in cases where the adverse event happens prior to creation of the note the implication will be the note motivated by a desire to CYA. Once credibility lost, it can rarely be recovered in a jury trial!

26. Northshore Trial Audit Trail Confusing w/ Baffling Time Stamps, Missing “Pending” Orders in Chart Puts Clinicians on Defensive about Record A long road once eDiscovery involved

27. Case Studies involving EHR Documentation Practices The Hybrid Problem, Johnson v. Hillcrest Health Center, Inc., 70 P.3d 811 (Okla. 2003) cf. Breeden v. Anesthesia West, P.C., 656 N.W.2d 913 (Neb. 2003). Failure to Comply The Joint Commission Journal on Quality and Patient Safety Interoperable Problem (Multiple EHRs, Multiple software), Volume 36, No. 4, Apr. 2010. Shared Logins http://www.justice.gov/usao/gan/press/2011/07-07-11.html Failure to Close the Loop Alerts and Interoperability Chicago case

28. Templating/ Artifacts The Templated Clinical Encounter Document Artifacts Cut/Copy/Paste Conflict between the templated material and the clinical assessment Reimbursement based templating targeted in Fraud & Abuse actions

29. Templating/ Artifacts Take this: Review of Symptoms: Constitutional: Negative Neurologic: Negative Cardiovascular: Negative Respiratory: Negative GI: Negative GU: Negative Family Hx: Negative Social Hx: Patient advised to cease smoking if smoker; if not advised to remain smoke free.

30. Templating/ Artifacts And compare with: Subjective: Pt is a 25 year old male presents for concerns with large amount of blood in toilet during bowel movements, further describes one week onset of 3-5 dizzy spells that quickly resolve within 2 min. In the same progress note!!!!

31. January Visit Subjective: Patient is a pleasant 28 year old woman who comes to the office today and reports she has progressed 32 weeks into her current pregnancy and followed by her obstetrician. She is here today….

32. February Visit Subjective: Patient is a pleasant 28 year old woman who comes to the office today and reports she has progressed 32 weeks into her current pregnancy and followed by her obstetrician. She is here today….

33. October Visit Subjective: Patient is a pleasant 28 year old woman who comes to the office today and reports she has progressed 32 weeks into her current pregnancy and followed by her obstetrician. She is here today….

34. Ex: Copy/Paste “F 5” Repetitive use of F 5 in a patient whom staff reports turning regularly. F 5 button used in many aspects of routine care and assessment.

35. Growing Concern Over Use of Templated Materials Early VA Study, 75% of charting contained templated material. 82 percent of residents' notes and 74 percent of attending physicians' notes included 20 percent or more copied and pasted material from the patients' records. Prevalence of Copied Information by Attendings and Residents in Critical Care Progress Notes. Thornton, J. Daryl MD, MPH; Schold, Jesse D. PhD, MStat, Med; Venkateshaiah, Lokesh MD; Lander, Bradley BA. (Dec 2012) CMS voices caution about use of copied material for reimbursement purposes.

36. The Case for Templated Material Efficiency Boilerplate analogue Consistency Checklists

37. According to an April 2010 editorial in the American Journal of Medicine (AJM) the copy and past function of the electronic health record (EMR) is… “one of the most egregious dangers of electronic charting” • Improper use of the cut and paste function has also been described as “medical plagiarism” and even “fraud”.

38. What Can We Do About Note Cloning? Review Use Policies Training Auditing

39. Honorable Mention: Narrative entries Typing errors; Speech recognition miscues; TXT MSNG (Auto correct!); E-mails in short hand or w/ abbreviations. New twist on “dictated, but not read”

40. Remedy MUST BE CAREFUL TO REVIEW EHR DOCUMENTATION AND PAPER/IMAGED EXPORT TO UNDERSTAND THE FUNCTIONS OF THE PARTICULAR EMR SYSTEM BEING USED TO MAXIMIZE LIKELIHOOD OF AVOIDING INVOLVEMENT IN LITIGATION

41. WHO IS RESPONSIBLE IF SYSTEM BREAKS DOESN’T WORK? Vendor Indemnification Clauses Learned Intermediary

42. System Incompatibilities Example 4: A soft tissue sarcoma went undiagnosed for at least 3 months, possibly as long as 6 months, because the radiologist's report from the Radiology Information System failed to file properly in the EHR. The referring physician failed to follow-up onthe results of the scan. The young mother of three went untreated, the cancer spread to the point that it was untreatable, and she died.

43. This may have been a systems error but ultimately responsibility fell to the physician because of accompanying human error.

44. Ineffective Safeguards built in to SystemExample 5: 53 year old male treated by pcp for general care and uncontrolled diabetes; Regular psa testing was ordered over 3 year period with slight increases. At last visit the patient’s psa was just above normal range. Ltr went out to patient to call regarding lab result but no ticklers in system for follow up; Patient did not call or return for care for two years after wife died and he lost insurance. Upon return, pcp focused on diabetes issues and no discussion regarding last psa was documented; One year later patient obtains new insurance and seen by new provider who orders psa. PSA results were markedly abnormal and patient subsequently diagnosed with metastatic prostate cancer.

45. Ticklers Dr. sued for failure to follow up on psa result. Dr. admitted during depo that if ticklers or follow up reminders were in place he would have more aggressively followed up on initial concerning lab when patient did not call or return and he would have re-ordered a psa on next visit had the prior value been flagged. Doc also admitted he ignored and later disabled reminder function because they were “too annoying”!

46. CLINICAL DECISION SUPPORT (CDS) Drug-Drug Interaction Screening Follow-Ups/ Abnormal Results Customized.

47. ALERT FATIGUE Alerts can be too frequent and/or too detailed. 49 to 96% of alerts are overridden or ignored. Of high importance alerts only 10.4% were accepted.

48. Reducing Your Risk • Nonetheless, with alert capability admittedly available in EMR system, the case is extremely difficult to defend legally. • Lesson: it is imperative that every practice and practitioner implement a system of tracking and follow up for missed visits, test results, referrals and schedules for preventative maintenance because the responsibility will fall to you. • Overrides should be documented.

49. CMIC Verdicts An internal medicine physician/pulmonologist did not follow up with a pt. after receiving an x-ray report noting a possible abdominal aortic aneurysm.  The pt. died from a ruptured AAA 2 years later.  Settled for $750,000 A gastroenterologist failed to timely follow-up on test results, order additional tests and start appropriate treatment for the pt’s auto-immune hepatitis, resulting in the pt’s death. A jury trial resulted in a $500,000 plaintiff’s verdict.

50. Fault of the patient Does patient have responsibility in any of the scenarios? Comparative negligence (Pltff v. Def) Contributory negligence (Def v. Def)