Electronic Medical Records and Peer Review - Essential Information

1. Electronic Medical Records and Peer Review – Information About Topics You Thought You Knew Jennifer Hardester STL Med Law, LLC 314 580 3274 Jennifer@stlmedlawllc.com

2. Examples . . . • About 2.5 years into litigation and 3 weeks before trial, client found 6 pages of records not stored in the normal “record” • Produced to opposing counsel and judge “recommended” sanctions • Video stored in vendor’s cloud related to surgical equipment showed portions of surgical procedure at issue in case – “no one” knew it was there until litigation well underway • Discovery requests didn’t cover this, so never produced

3. Examples, continued • Peer review process is nicely memorialized in Bylaws, policies and guidelines. • Adverse Event occurs and clinical staff start meetings, dialogue, text messaging – all before triggering process • Other “issues” exist in adverse event which need to be addressed on a business level • Leadership reaches out to discuss with third parties, all outside of the peer review process

5. Medical Records • What is the “legal medical record”? • How is that different from the “record of care”? • What is a “designated record set”? • 45 CFR § 164.501 • Different electronically than paper, but we had these issues with paper too • TJC and CMS expects hospitals and other healthcare entities to define its medical record

6. Medical Records, continued • Of course, standard “ask” for everyone is the record of care • Problem is….lots of records exist – even records that address the care provided – which don’t end up in the final record • Couple of tips for everyone: • Go see the records in their native format • Remember what an authorization gets versus a court order (45 CFR § 164.524 vs §164.512(e),(f))

7. So, what is Missouri Peer Review? • Peer Review Statute – RSMo. §537.035 • Communications regarding patient care made by a qualified peer review committee from disclosure in the context of litigation involving an alleged failure to provide appropriate care

8. So, what’s up with Peer Review? • Applies to hospital committees of “health care professionals” (licensed personnel): • Interviews, memorandums, proceedings, findings, deliberations, reports and minutes concerning the health care provided any patient • Persons in attendance cannot be required to disclose or testify • Protections cannot be waived • Committee members may invoke privilege but only with respect to materials created or generated as part of the peer review process

9. So, what’s up with Peer Review? • Issues: • Discoverable if otherwise available • Can be required to testify as to personal knowledge • Protections do not apply in peer review litigation or in licensure actions • Not clear – state protection in federal court with federal cause of action? • Not clear as to whether information can be freely shared throughout a healthcare system

10. Peer Review Process, cont. • What’s required? • Joint Commission – Standard LD.04.04.05: As part of the safety program, the leaders create procedures for responding to system or process failures. The leaders provide and encourage the use of systems for blame-free internal reporting of a system or process failure, or the results of a proactive risk assessment. • Missouri State Hospital Regs: 19 CSR 30-20.112 and 19 CSR 30-20.082(12)

11. Peer Review Process, cont. • “Normal Process” for event reviews • Event occurs • Debrief • Decision on how to proceed (stop analysis, sentinel event, other) • Morbidity and Mortality meeting • External peer review? • What is the organization’s policy/procedure and did they follow it?

12. Federal Patient Safety Privilege • Patient Safety Organization (PSO) – Federal Patient Safety Privilege (42 U.S.C. §§299b-22) – WHAT?? • Generated by or requested by an approved Patient Safety Organization (“PSO”) • “Patient Safety Work Product” – data, reports, records, memoranda, analyses (like a Root Cause Analysis), or statements reported to a PSO for the conduct of patient safety activities • So….any data outside of the PSWP would not qualify for this privilege • Also does not apply to information collected for purposes in addition to the PSO • Most information is collected for purposes other than/in addition to the PSO, so it’s likely privilege doesn’t apply

13. Attorney-Client Privilege • Unlike work product, protected even if other side has no way to obtain the information • If client “corporation,” privilege always attaches to protect communication with top management • Lower level too – but only if: • Securing legal advice at direction of superior • Subject Matter within employee’s scope • Only for those who need to know • Practical Application

14. Other Issues to Consider – Starting at the Beginning • Are you sure you have all the records? What are the records? • Audit trails? EMR Systems? • Equipment Data • Policies/procedures/Bylaws about record retention, event investigation • Regulatory audits/reports? Fact finding and internal investigations? External peer review? • Cast a broad net in terms of asking questions about who’s been involved

15. Lessons Learned? • Ask questions and figure out the record • Look at record in native/original format • Ask a lot of questions of a variety of people • Think department-wide versus hospital-wide in terms of asking about records • Event “investigation” vs. debrief vs. RCA/sentinel event analysis vs. peer review