The First 24 Hours: TimeSensitive Risk Management in
the Face of Catastrophe
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Today’s Presentation
• General Guidelines and Considerations to
Observe During First 24-Hours
• Putting it All Together - An Action Plan
• Recent Developments – Electronic Records
• Takeaway Thoughts and Questions
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General Guidelines and Considerations to
Observe During First 24-Hours
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I’m Sorry Law / Doctor-Patient Relationship
Peer Review / Quality Assurance Privilege
Preserve Medical Record / Evidence
Employee’s File / Reprimand
Privacy Considerations
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I’m Sorry Law / Doctor-Patient Relationship
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I’m Sorry Law / Doctor-Patient Relationship
• Background
– Initiatives that advocate full disclosure and apology
to patients who suffer unanticipated outcomes during
medical care are gaining momentum.
– 35 states have adopted variations of “I’m Sorry” law.
– Advocates of disclosure point to emerging literature
that suggests that full disclosure of unanticipated
outcomes decreases rather than increases the
likelihood of lawsuits.
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I’m Sorry Law / Doctor-Patient Relationship
Ohio Law – R.C. § 2317.43 - Use of defendant's statement of sympathy as evidence in medical liability
action prohibited:
(A) In any civil action brought by an alleged victim of an unanticipated outcome of medical care or in any
arbitration proceeding related to such a civil action, any and all statements, affirmations, gestures, or
conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense
of benevolence that are made by a health care provider or an employee of a health care provider to
the alleged victim, a relative of the alleged victim, or a representative of the alleged victim, and that
relate to the discomfort, pain, suffering, injury, or death of the alleged victim as the result of the
unanticipated outcome of medical care are inadmissible as evidence of an admission of liability or as
evidence of an admission against interest.
(B) For purposes of this section, unless the context otherwise requires:
(1) "Health care provider" has the same meaning as in division (B)(5) of section 2317.02 of the
Revised Code.
(2) "Relative" means a victim's spouse, parent, grandparent, stepfather, stepmother, child,
grandchild, brother, sister, half brother, half sister, or spouse's parents. The term includes said
relationships that are created as a result of adoption. In addition, "relative" includes any person who
has a family-type relationship with a victim.
(3) "Representative" means a legal guardian, attorney, person designated to make decisions on
behalf of a patient under a medical power of attorney, or any person recognized in law or custom as a
patient's agent.
(4) "Unanticipated outcome" means the outcome of a medical treatment or procedure that differs
from an expected result.
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I’m Sorry Law / Doctor-Patient Relationship
“I’M SORRY” STATUTE
Hill v. St. Onge, 2009 U.S. Dist. LEXIS 82195 (S.D.
Ohio).
• Defendant sought to exclude statements under R.C.
2317.43
• Plaintiff claimed Fed. R. Evid. applied
• R.C. 2317.43 controls because it is “intimately bound
up” with the state’s substantive policy of allowing
doctors to express sympathy to patients without penalty
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I’m Sorry Law / Doctor-Patient Relationship
Important Considerations:
• Unanticipated Outcomes - Terminology
– Term first used by JCAHO to refer to outcome of care that is different from that expected by
health care professionals and the patient at the start of health care intervention.
– Refers to outcome of care, the process of care.
– Does not imply medical error.
– Informed consent.
• Ethical Considerations
– JCAHO requires patients, and families when appropriate, are informed of outcomes of care,
including unanticipated outcomes
• Patient Surveys
– Patients want explicit statement that an error occurred, an apology, and information about what
the error was, how it will affect their health, why the error occurred, and how recurrence will be
prevented.
• Impact on Potential Resolution
– Studies show a full apology tends to promote more rapid dispute resolutions and lower financial
awards.
• Opponents of I’m Sorry Policy
– Many still believe that a vast majority of patients injured by negligent care never sue, and the
lack of awareness of the error may be an important contributor to this low rate of litigation.
• Importance of Doctor-Patient Relationship / Bedside Manor
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I’m Sorry Law / Doctor-Patient Relationship
• PRACTICAL DISCUSSION
– Who communicates with patient?
– What is said?
– Does strength of doctor-patient relationship have
impact?
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Peer Review / Quality Assurance Privilege
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Peer Review / Quality Assurance
• As Defined by Statute – Tort Reform – Ohio
Revised Code § 2305
• Case Law Interpretation Around Ohio
– Incident Reports
– Review Committees
– Documentation
• How does that apply to me?
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Confidential by Statute
•ORC § 2305.25
– Definitions – Hospital, long-term care
facility…health care entity
•ORC § 2305.24
– Any information, data, reports,…made available
to QA…are confidential
•ORC § 2305.252
– Proceedings and records of peer review
committee – not subject to discovery
•ORC § 2305.253
– Incident Report or Risk Management Report not
subject to discovery
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ORC § 2305.25
• Health care entity
– Any entity, that conducts as part of its regular business activities
professional credentialing or quality review activities involving the
competence of, professional credentialing, professional conduct of, or
quality of care provided by health care providers.
• Incident report
– Means a report of an incident involving injury or potential injury to a patient
as a result of patient care provided by health care providers, that is
prepared by or for the use of a peer review committee of a health care
entity and is within the scope of the functions of that committee.
• Peer review committee
– Means utilization review committee, quality assessment committee,
performance improvement committee, credentialing committee, or other.
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ORC § 2305.24
Confidentiality
Any information, data, reports, or records made
available to a quality assurance committee is
confidential and shall be used by the committee and
the committee members only in the exercise of the
proper functions of the committee.
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ORC § 2305.252
Protection of Peer Review Committee Information:
• Proceedings and records within the scope of the peer
review committee of a health care entity shall be held in
confidence and shall not be subject to discovery or
introduction in evidence in any civil action against a
health care entity or health care provider.
• No individual who attends a meeting of a peer review
committee, or provides information to a peer review
committee shall be permitted or required to testify as to
any evidence or other matters produced or presented
during the proceedings of the peer review committee.
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ORC § 2305.253
Protection of Incident Reports:
• An incident report and the contents of an incident report
are not subject to discovery in, and are not admissible
in evidence in the trial of, a tort action.
• An individual who prepares or has knowledge of the
contents of an incident report shall not testify, and shall
not be required to testify, in a tort action as to the
contents of the report.
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Absolute Slam Dunk?
• Pretty Clear Statutes
• Very Broad Language
• Umbrella of protection to
information collected and
maintained by peer
review committee
• Specifically targets
incident reports
regarding injury suffered
by patient
• Any information, data, reports,
or records made available to a
QA committee are confidential
• End of topic/discussion –
Complete shield?
NO
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General Assembly v. Courts
•Ohio legislature intends for safeguards to protect
DISCOVERY
•Case law erodes the protection
•Doe v. Mt. Carmel Health Sys. – Franklin County 2005
– Court narrowly construed purpose of statutes – no duties,
rights or obligations
– Statutes only “clarified” whether information is discoverable or
protected by privilege
Recent cases that erode the privilege
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First Prove Existence of Statutory Peer
Review Committee
•Bansal v. Mt. Carmel Health Systems, Inc. – Franklin
County 2009
– Committee must conduct quality review activities involving the
competence of, professional conduct of, or quality of care provided by
health care provider.
– Must next prove documents are records within scope of a peer review
committee.
•ORC § 2305.25(E)(1)
– Conducts professional credentialing or quality review activities.
– Conducts any other attendant hearing process initiated as a result of a
peer review committee’s recommendations or actions.
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Can We Just Call it an “Incident Report”?
•Rinaldi v. City View Nursing & Rehab. – Cuyahoga
County 2005
– Mere use of title “investigation report” or “incident report”
is insufficient to demonstrate the reports were actually
incident reports prepared for use by a peer review
committee.
– Committee must perform functions identified in ORC §
2305.25 (and prove it if discovery dispute arises).
NO!
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Can We Just Call it an “Incident Report?”
•Are they “incident reports” within definition of
ORC § 2305.25(D)?
– In camera review if necessary to determine that
records sought are in fact incident reports
– Smith v. Manor Care of Canton – Stark County 2006
• If unclear whether documents used by peer review
committee and if existence of committee is at issue, party
claiming privilege must provide trial court with list of
evidence the peer review committee considered
– So much for the shield!
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Privilege is NOT Absolute
•Brzozowski v. Univ. Hosp. Health Sys. –
Cuyahoga County 2005
– Patient fell in room resulting in subdural hematoma and
subsequently died
– Plaintiff sought incident report in discovery
– Privilege is not absolute if the information cannot be
obtained from original sources
• Hospital could have avoided disclosure of report if the medical
records sufficiently detailed the event and incident report
indicated it was prepared for peer review committee.
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You Have The Burden!
•Manley v. Heather Hill – Geauga County 2007
– In order to invoke the peer review privilege, a defendant
must establish that the documents being sought were
incident reports prepared by, or for the use of, a peer
review committee.
– Party claiming privilege must prove the existence of the
peer review committee and that the committee
investigated the incident in question.
– Party asserting a report as an incident report has the
burden of proving it is an incident report.
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NO Privilege Under ORC § 2305.253?
•Flynn v. Univ. Hosp. – Hamilton County 2007
– Hospital failed to show that an incident report was
privileged under statute because it failed to show what was
required under ORC § 2305.25(D).
– Did not prove it was created for purpose of submission to
quality assurance committee.
– However, the attorney-client privilege did apply
• Incident report was prepared for the attorney in its risk
management department for the specific purpose of notifying the
department and its outside legal counsel of possible claims.
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Always Submit to a Peer Review
Committee to Protect Privilege
•Freudeman v. The Landing of Canton – United States
District Court (Northern District of Ohio) – May 2010
– Nursing home had to disclose reports of patients’ medication
errors to plaintiff after conceding no peer review protection
(no indicia documents were used for peer review and
protected).
• Send report to peer review committee to ensure privilege argument.
– Can still argue physician-patient privilege as it co-exists with
peer review privilege.
• Report must be a communication necessary for a physician to treat or
diagnose a patient.
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You May Have to Testify
•Giusti v. Akron Gen. Med. Ctr. – Summit County 2008
– Participating in peer review does not automatically protect
against having to give testimony in deposition.
• Still must testify as to items within your knowledge.
– To avoid disclosure, must prove information sought falls into
protected categories:
• Testimony before the peer review committee
• Information provided to the committee
• Opinions formed as a result of the committee’s activities
– No protection in this case - doctors’ conversations were not
part of peer review committee proceeding.
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Practice Tips
•Establish a Peer Review Committee
– Create formal positions, name of committee and/or scope of committee
– Establish a meeting schedule
– Discuss each case that is presented
•Create bylaws or policies THAT ARE FOLLOWED!
•Do not discuss the subject outside of the formal process
•Label all documents part of the process
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Author
Prepared at whose direction
Date request was made
Label that indicates Peer Review Committee’s Eyes Only
•Notes from meeting categorized/saved similarly
•Keep abreast of the current definition and requirements
•Involve legal counsel
– Prepare the incident report for legal counsel with the specific purpose of notifying
counsel of possible claims to invoke the attorney-client privilege (must actually do
it, not just put language on form)
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Preserve Medical Record / Evidence
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Preserve Medical Record / Evidence
Never Ever Alter !
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Do not obliterate
Errors: Date, Time, Initial
Never chart for someone else
If documented later, chart the time
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ALTER
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Preserve Medical Record / Evidence
• Maintain Complete Original Medical Record
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Preserve Medical Record / Evidence
The Complete Medical Record May or May Not Include:
• Admission record
• History and Physical
• Physician orders, and/or certifications of medical necessity
• Patient questionnaires associated with physician services
• Progress notes and/or progress of another provider that are
referenced in your own note
• Nursing notes
• Treatment logs
• Related professional consultation reports
• Procedure, lab, x-ray and diagnostic reports
• Amended Medical Records
• Discharge Plan
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Preserve Medical Record / Evidence
Ohio Statutory Guidance regarding the “Complete Record”?
The Ohio Administrative Code (Section 5122-14-13), when referring to the administration of a psychiatric
facility, describes the “necessary” components of the “medical record” as follows:
(1) Patient demographic information, including indication of legal status as a voluntary or involuntary patient;
(2) All legal documents, including, as appropriate, an application for voluntary admission signed and dated by
the patient, written requests for release pursuant to section 5122.03 of the Revised Code, and all legal
documents pertaining to civil commitment and guardianship;
(3) The reason for admission including presenting problem(s), precipitating factors, and initial diagnosis;
(4) Previous hospitalizations;
(5) Reports of all patient assessments and examinations;
(6) An individualized treatment plan which shall include criteria for discharge and which shall meet
requirements of section 5122.27 of the Revised Code;
(7) All medical orders;
(8) Documentation of the patient’s progress, and other significant patient events which could impact on
treatment;
(9) Appropriate, complete, signed and dated consents for treatment, and for release of confidential information;
(10) A discharge summary completed within thirty days after discharge and signed by the attending or treating
physician; and
(11) A plan for aftercare.
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Preserve Medical Record / Evidence
Other Evidence to Preserve:
• Staffing, Schedules, Patient Census
• Names and Contacts of Potential Witnesses
• Written Policies and Procedures
• Business Records
• Chain of Custody / Medical Records
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Employee’s File / Reprimand
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Employee’s File / Reprimand
• Do not discard
– Defense against negligent hiring, negligent retention
• Assume file may be read by Plaintiff’s Counsel
• May help establish employment relationship, or
lack thereof
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Employee’s File / Reprimand
• RRACTICAL DISCUSSION:
- Personnel File
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Privacy Considerations
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Privacy Considerations
• Communication with family regarding care and outcome
• Records Requests
– Pursuant to R.C. 3701.74, medical records may only be
provided at the request of a "patient, a patient's personal
representative or an authorized person."
– The "personal representative" in some instances may include
person with health care power of attorney, or an executor of
the patient's estate.
– A Will naming someone as executor is not sufficient. The Will
must be probated first. The Court must then provide the
designated person with a letter of authority.
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Putting it All Together – An Action Plan
• Secure Record / Evidence / Equipment / Data
Back-up
• Interviews with Personnel
• Counseling for Involved Personnel
• Communication with Patient / Family
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Recent Developments - Electronic
Records
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Recent Developments - Electronic Records
E-Discovery
• Preservation Obligation
– Litigation Hold Letters
– Spoliation
• Discovery Process
– Motion to Apportion Cost
• State Court v. Federal Court
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Takeaway Thoughts and Questions
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Communications
Control
Preservation
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Thank You
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