1. 7/27/2019 2:50 AM
Electronic Medical Records and Peer Review – Information About Topics You Thought You Knew
Jennifer Hardester
STL Med Law, LLC
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2. 7/27/2019 2:50 AM
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
© 2007 Microsoft Corporation. All rights reserved. Microsoft, Windows, Windows Vista and other product names are or may be registered trademarks and/or trademarks in the U.S. and/or other countries.
The information herein is for informational purposes only and represents the current view of Microsoft Corporation as of the date of this presentation. Because Microsoft must respond to changing market conditions, it should not be interpreted to be a commitment on the part of Microsoft, and Microsoft cannot guarantee the accuracy of any information provided after the date of this presentation. MICROSOFT MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, AS TO THE INFORMATION IN THIS PRESENTATION.

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
Harmful – pointed out discrepancies between witnesses and also between deposition testimony and the discussions immediately after the event
Causation discussed
POST EVENT INVESTIGATION v PEER REVIEW

4. Harmful – pointed out discrepancies between witnesses and also between deposition testimony and the discussions immediately after the event
Causation discussed
POST EVENT INVESTIGATION v PEER REVIEW

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 §
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
Harmful – pointed out discrepancies between witnesses and also between deposition testimony and the discussions immediately after the event
Causation discussed
POST EVENT INVESTIGATION v PEER REVIEW

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 § vs § (e),(f))
Harmful – pointed out discrepancies between witnesses and also between deposition testimony and the discussions immediately after the event
Causation discussed
POST EVENT INVESTIGATION v PEER REVIEW

7. So, what is Missouri Peer Review?
Peer Review Statute – RSMo. §
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 : 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 and 19 CSR (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?
Transition – now that we’ve gone over the Peer Review statutory privilege, let’s see how event investigations really work in the hospital setting
Event occurs
Phone call
Incident report
Text?
Debrief
More immediate meeting with people involved in event
Fact finding
At some point, decision on how to proceed (stop analysis, sentinel event, other)
Morbidity and Mortality meeting
External peer review?
Communication after an event
Directed by counsel?
Part of the formal peer review process?
Work product?
? Text? Discoverable if not done correctly.
Employee/Non-Employee Interviews
What’s the purpose of the interview?
Who’s doing the summary and at whose direction?
Where will summary go?
Notes?
Sentinel Event/RCAs
Participants who aren’t part of the committee or who aren’t healthcare professionals

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
Communication after an event
Directed by counsel?
Created by eee at attorney’s request and for use by attorney
Incident report
Outside scope: communication between two employees if attorney not involved

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
OTTR, Case Management, Dietary, Logs

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