Transcript The-4-Cs-of-Risk-Management-2

The 4 C’s of Risk Management: Consent, Contracts,
Coaching Clinicians After an Adverse Event, and Complaints
The Arizona Society for Healthcare Risk Management
Presented by: Jean Turvey, RN, BSN, MSBL, CPHQ, CPHRM, ARM
No, really, thank you…
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Objectives
At the conclusion of this program, participants will be able
to:
1. Describe the basic principles underlying informed consent in
the healthcare setting, the exceptions to informed consent
situations, and issues that can arise related to the informed
consent process.
2. Explain terms and phrases commonly used in contracts in
healthcare settings.
3. Describe standard provisions and terms in healthcare
contract indemnification provisions.
4. List all the significant questions to ask a caregiver calling you
to report an adverse event or unusual occurrence.
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Objectives
5. Describe the four elements of negligence.
6. Identify patient or resident unusual/adverse occurrences that
are at high risk for liability claims by identifying the presence
or absence of the elements of negligence.
7. Define hospital “grievance” under the Medicare Conditions of
Participation and describe the required response and
information management.
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Not Objectives
 At the conclusion of this
program, participants will
not be able to:
 Add the credential JD to
their name tag (unless they
are a lawyer).
 Wear the black robe—even
if they look good in black.
 Try cases.
 Approach the bench.
 Give legal opinions
regarding contracts or
informed consent
situations.
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Informed Consent
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Underlying Principles
 What does the average
lay person understand
about the proposed
medical test or
treatment (WITHOUT
being “consented”)?
 Consider:
– Venipuncture
– Pap tests
– IV starts
 General facility consent
for treatment.
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The Facility’s Role in Informed Consent
 “Hospitals must utilize an
informed consent
process that assures
patients or their
representatives are given
the information and
disclosures needed to
make an informed
decision about whether
to consent to a
procedure, intervention,
or type of care that
requires consent.”
(Medicare CoPs)
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Informed Consent Basics
 A process, not a form
 Providing information to the patient or responsible
party regarding the proposed treatment/test is the
responsibility of the provider/physician who is
performing the treatment/test
 A process that is validated by hospital staff
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What to Disclose?
 Nature and purpose of the treatment/test
 Risks and benefits
 Alternatives, including the risks and benefits of each
 Risks and benefits of NO treatment/test
 Risks to disclose are on a continuum, but should include
– Death, disability, disfigurement
– Major change in lifestyle
 Provider ownership or interest in health care facilities
 Urgency to undergo the treatment/test
 Consequences of deferring or delaying treatment/test
 “Prudent Patient” vs. “Reasonable Practitioner” standards
(Carroll)
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Issues With the Informed Consent Process
 Effective communication, including patients with
communication disabilities or language barriers.
 Culturally appropriate communication.
 Patient literacy and health illiteracy.
 Patients don’t know what to ask and just want to get
better.
 Complex consent forms.
 Intimidated patients.
 Patient’s retention of information, especially over time.
 Who signs the consent form if the patient is unable and
there is no designated decision-maker (no DPOA, etc.)?
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Informed Consent and Specific Situations
 Emergency treatment
 Therapeutic privilege
 Compulsory treatment
 Informed refusal of care
 Withdrawal of consent
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The Risk Manager’s Role With Informed Consent
 KNOW WHEN TO CALL LEGAL COUNSEL
 Consent risk identification
 The informed consent form
 The documentation of informed consent
 Staff and provider education
 Complaints alleging a violation of the patient’s right to
make “informed decisions” about their care—
GRIEVANCES
 Informed consent policy, procedure, and form(s)
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(Broad) Informed Consent Policy Issues
 Requirements for a valid consent for treatment
 The patient’s capacity to give consent
 Advance directives and surrogate decision makers
 Consent to participate in human subjects research
 Documentation requirements
 Specific situations:
–
–
–
–
–
–
Anesthesia
DNR
Organ procurement
Authorizations for autopsies
Patients from correctional facilities
Refusals of certain treatments, such as blood transfusions
(Carroll)
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Slow Down
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Use Caution with these Informed Consent Situations
 When asked for advice related to informed consent by
physicians or other providers, especially if not
employed by your facility
 Minors
 “Emancipated minors”, “mature minors”
 Adolescents
 Incompetent patients
 Patients with questionable capacity to make informed
decisions
 Human subjects research
 Sterilization for some patient populations
 ECT (shock therapy)
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CMS and Informed Consent
 Trick question
 Three sections:
– §482.13(b)(2)
– §482.24(c)(2)(v)
– §482.51(b)(2)
Patient rights
Medical records
Surgical Services
 You must access ALL THREE to answer questions
related to CMS and informed consent
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Thank You Very Much
Questions
and
Discussion
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Contracts
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Contracts—and Your Hospital or System
 Black’s Law Dictionary—NINE pages devoted to the
word, “contract”
 Hospital Contracts Manual
– Published by Aspen Health Law and Compliance Center
– “About 3,180 pages”
– “Supplemented twice per year”
 Hospitals may have “many” contracts
– 800-1,000 (or more)
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(LANSA)
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For Starters
 “An agreement between two or more parties creating
obligations that are enforceable or otherwise
recognizable at law.”
(Black)
 “Contracts” can be in different forms, but for purposes
of today: WRITTEN.
 What are the legal name of all business entities?
 (Depending on what type of organization) must
contracts be competitively bid and are there maximum
term limits?
 Who is authorized to sign on behalf of your
organization?
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Types of Contracts in Health Care Facilities
 Physicians and other providers
 Exclusive provider contracts with sole source companies
(i.e., a radiology group)
 Equipment and supplies and other vendors
 Real estate purchases, sales, leases
 Insurance policies
 Clinical affiliation agreements
 Temporary staffing agencies
 Construction
 Provider “contracts” with patients
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Contract Basics—Terminology
 Boilerplate—standard templates
 Indemnify—a promise to pay
 Hold harmless—to absolve another party from any
responsibility for damage or other liability arising from
the transaction
 Subrogation—amount paid by an insurer is recovered
from a third party
 Alternative Dispute Resolution (ADR)—includes
arbitration (binding or nonbinding) and mediation
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Contract Basics—Typical Sections
 Definitions, including “who is who” (use correct and
legal names and keep track of changes—d.b.a., etc.)
 Commitment—who will do (or not do) what
 “Entire agreement”
 Effective and termination dates—“evergreen”
 Limitations
 Amending or modifying the executed contract
 Risk transfer—insurance, indemnification, liability limits,
subrogation
 Limitations
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Contract Basics—Typical Sections
 Restrictive covenants (not to compete)
 Resolution of disputes
 Governing law
 Liquidated damages
 Circumstances under which the contract can be
terminated
– For or without cause
– Definition of “for cause”
 Signatures of all parties—each party should have a
copy of the final executed document
 Attachments or exhibits
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Contracts With Service Providers
 Typical requirements
 Comply with licensure and accrediting organizations
requirements
 Certification that the contractor is not a “sanctioned
person” under federal or state programs or law
 Job descriptions, competency assessments, clinical
privileges
 Training
 Quality control, PI, measurable standards for quality
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Contractual Risk Transfer—Insurance
 Minimum required amounts of professional liability
insurance
 Property, workers’ compensation, auto, major medical
health coverage
 Dollar limits of coverage
 Evidence of insurance coverage (certificate of insurance
or named as additional insured)
 General liability insurance for damage to property or
injury to third parties
 Fidelity bonds
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Contractual Risk Transfer—Indemnification Provisions
Some considerations:
 Provisions range from basic to legally complex.
 Look for each party’s responsibility and reasonableness
of the provisions.
 Do the provisions “fit” within your insurance coverage
or self-insurance coverage?
 What risks are your hospital assuming? Affordable?
 How do risks assumed impact the hospital’s limits of
insurance coverage?
 Generally, it is appropriate for each party to contract to
retain responsibility and liability for those contract
activities and operations under its control.
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Indemnification Provision—One Example
 “Each party, Health Care Entity, and contractor, agree
that with respect to any claim or lawsuit arising out of
the activities described in this contract, each party shall
only be responsible for that portion of any liability
resulting from the actions or omissions of its own
directors, officers, employees, and agents . . . Each
party shall defend, indemnify, and hold-harmless the
other party from and against any and all liability, loss,
expense, reasonable attorneys’ fees, or claims for injury
or damages arising out of the performance of this
contract . . . ”
 Work with your legal counsel to develop and
review basic indemnification language that
might serve as a template for contract review.
(Carroll)
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When Might a Contract Be Unenforceable?
 Illegal—state law, etc.
 Signed under duress or undue influence
 Fraud
 Lack of capacity of one of the parties
–
–
–
–
Minors
Adolescents—exceptions
Insanity
Mental incapacity
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The Risk Manager’s Role With Contracts
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The Risk Manager’s Role With Contracts
 If given the opportunity, assist with contract review
processes.
– Timeliness.
– Efficiency.
– Communication with affected people and departments.
 READ the document word for word (you’ll thank me
later).
 Look for errors.
 Get counsel involved according to:
–
–
–
–
–
Senior leadership direction.
Hospital or system processes and practices.
Type of contract.
Issues and concerns raised by the document.
Other.
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Whoa
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Get Help
 Provider contracts, especially the noncompetition
clauses.
 Service contracts.
 Large equipment purchases.
 Vendors insisting on using their own contract
templates.
 Unusual indemnification language.
 Boilerplate language on contract templates that:
– Does not match the agreement you thought you had.
– Is not consistent with state or federal law.
 With anything else that makes you uncomfortable or
“fires” your instincts.
 Remember—you are not a lawyer (unless you ARE!).
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Thank You Very Much
Questions
and
Discussion
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Coaching Clinicians After an Adverse Event
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When Do They Call You?
 Nothing good ever happens in Risk Management after
3 p.m. on Friday afternoon.
 Nothing good ever happens in Risk Management at
10 a.m. on Sunday morning.
 You don’t get called about the “easy stuff” because
they have already figured that out.
. . . so you need to be ready to help caregivers through
tough situations especially when other sources of help
are limited or unavailable.
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When Do They Call You?
 Unexpected patient deterioration
 Medical error made or detected
 Informed consent and “decision-maker” issues
 Documenting an adverse event
 Ethical issue
 Threat of litigation
 Served a summons/complaint alleging medical
malpractice
 Lots of other situations, if you are lucky
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Why Do They Call You?
 You are “on call” (!)
 Critical “thinker” and smart
 Have or can get information
 Common sense and reasonable
 Caring and compassionate
 Positive attitude and energy
 Well-connected and pivotal within your organization
 Decision-maker or give input into important decisions
 Trusted and keep confidences
 Integrity—you are known for doing the right thing
 YOU KNOW WHO TO CALL
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This Is How the Call Goes . . .
“Hi. Are you busy? I think
I’m in trouble. Something
bad just happened . . . how
much trouble am I in?”
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This Is How the Call Goes . . .
(take a deep breath and in your
calmest voice, say)
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This Is How the Call Goes . . .
“All right, let’s talk down through it.”
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The Questions to Ask
1. “HOW IS THE PATIENT?” and “How are YOU?”
– Remember the elements of negligence.
– Decide. Near miss? Serious event? Potentially
compensable event?
– Reach for paper and pen to start your risk management
file notes.
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Questions to Ask
2. Family. Any family around? Were they at the bedside?
What have they been told? What have they said?
3. What happened? The FACTS in chronological order.
(Think about which senior leader will need to know about
this event—right now.)
4. Any witnesses? Who was also present or aware of the
event? Who else might have additional information?
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Questions to Ask
5. Discuss documentation of the event in the record and the
incident report. What has already been documented? What
needs to be documented?
6. Remind them of confidentiality related to this event—who
they can, and should, talk to. Invite them to call you
personally if they remember more significant details. Ask
how you can reach them later if you need to.
7. Offer support—answer questions they have, including
possible peer review process, RCA, disciplinary action
concerns, etc.
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(A Little Goofy, But it Works . . . )
P
Patient
F
Family
CH Chronological facts and chain of command
A
Any witnesses with additional facts
N
Notes—documentation
G
(Gag) Confidentiality
S
Support for the caregiver
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The Four Elements of Negligence
1. Duty
2. Breach of duty
3. Damages
4. Causation
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Why Do Patients Sue?
Process issues identified during depositions of
patients and families:
 Perceived unavailability—“No one returned our calls”
 Devaluing the patient’s or family’s views—perceived
insensitivity to culture or socioeconomic differences
 Poor delivery of medical information
 Failure to understand the patient’s or family’s
perspective
 Unsatisfactory or incomplete explanation of why an
adverse outcome occurred
(ACS)
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Important Concept: Failure to Rescue
 “ . . . a bedside caregiver’s failure to save—or initiate
saving—a hospitalized patient’s life or extremity in the
event of a complication . . . ”—patient safety
indicator/measure (AHRQ)
 A legal claim against hospitals and providers.
What can be done AFTER this event?
1. Communication with the patient/family and try to
maintain, initiate, or maintain a relationship with them,
and;
2. Assist caregivers with support and assistance regarding
appropriate and factual documentation—events
prior to, during, and post-event.
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Slow Down
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Serious Adverse Events
 Sentinel events, “no pay”, or “never events”
 Preventable medical errors with injury
 Serious nosocomial infections requiring prolonged
treatment
 Unexpected transfers to ICU following medical harm
 Complaints or grievances regarding serious care issues
with reported medical harm
 Requests or demands for reimbursement for perceived
medical harm
 Threats of litigation
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Complaints and Grievances
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Why Is This Work Important?
 It is the right thing to do.
 Improves patient care and patient satisfaction.
 Enhances service recovery.
 It works with the organization’s culture of quality and
effectiveness of performance.
 Fulfills federal regulations and accreditation
requirements.
 It is good risk management.
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Why Is This Work So Hard?
 Working with unhappy patients and families.
 May be outside of the your comfort zone.
 You (or your leadership) may be afraid to say or do
something “wrong”ESPECIALLY IN WRITING.
 Responding to grievances from discharged patients
does not feel like an emergency for today.
 Investigations and formulating responses take TIME.
 The required timeframe for response is SHORT.
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CMS Regulations
 For your reference:
– Conditions of Participation: Patients’ Rights;
42 FR §482.13
– Appendix A of State Operations Manual, Survey Protocols
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CMS Continued
 Federal regulations.
 A process must be established.
 Prompt resolution of grievances.
 Governing body must approve and be responsible for
the effective operation of the grievance process.
 Governing body must review and resolve grievances
unless it delegates in writing this responsibility to a
grievance committee.
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CMS Continued
 At a minimum . . .
– Clearly explained procedure
– Timeframes for review and response must be specified
– The patient must be provided with a written notice of the
hospital's decision, including the name of a contact person
– What steps were taken to investigate
– The results of the grievance process
– The date the hospital completed the investigation and
response
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From the CMS Surveyor Guidelines…
 This is IMPORTANT . . .
– “A ‘patient grievance’ is a formal or informal written or
verbal complaint that is made to the hospital by a patient,
or the patient’s representative regarding the patient’s care
(when the complaint is not resolved at the time of the
complaint by staff present), abuse or neglect, issues
related to the hospital’s compliance with the CMS
Conditions of Participation, or a Medicare beneficiary
complaint related to rights and limitations provided by 42
CFR 489.”
 And . . . (and this is a complaint . . .)
– A patient issue is that is resolved by staff present at the
time the complaint comes forward.
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Examples of “Grievances”
 A written complaint (including e-mails and faxes) is
ALWAYS considered a grievance.
 Other staff (e.g., the patient representative) are called
in to resolve an issue that patient care staff cannot (or
do not) resolve immediately for a patient in the
hospital.
 A patient or their representative calls or writes the
hospital about concerns related to care or services that
were not resolved during their stay OR they chose not
to address their issue during their stay.
 A patient or representative requests their complaint be
handled as a formal grievance.
 A patient requests a response from the hospital.
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So What Is Not a Grievance?
 A patient in the hospital calls the patient representative
first and has not tried to resolve the issue with the
involved unit. The patient representative immediately
calls the patient’s unit and patient care staff present
resolve the issue “at that moment.”
 Billing issues are usually not grievances UNLESS the
complaint also contains elements addressing patient
service or care issues.
 Post-hospital verbal communication regarding patient
care that would routinely have been handled by staff
present if the communication had occurred during the
stay—NOT a grievance.
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Timeliness of Response Is Important
 From 42 CFR §482.13(a)(2)
 Tag A-0122
– “On average, a time frame of seven (7) days for the
provision of the response would be considered
appropriate.”
– And note . . .
 “. . . grievances about situations that endanger the
patient, such as neglect or abuse, should be reviewed
immediately . . .”
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Absolute Requirements
“If the grievance will not be resolved or if the investigation
is not or will not be, the hospital should inform completed
within seven (7) days the patient or the patient’s
representative that the hospital is still working to resolve
the grievance and that the hospital will follow-up with a
written response within a stated number of days . . .”
“. . . in all cases the hospital must provide a written
notice (response) to each patient’s grievance(s).
“responding to the substance of the grievance” and also
“identifying, investigating, and resolving any deeper,
systemic problems indicated by the grievance.”
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Hospital Policies and Practices Should . . .
 Comply with current federal regulations, pertinent state
laws, and other regulatory standards.
 Be consistent within your hospital system.
 Be consistent with your hospital’s internal culture and
philosophies.
 Clearly lay out an understandable, memorable
procedure for staff and leadership to follow.
 Support staff and management in addressing patient
complaints and grievances.
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Information Management
 Multiple bits and pieces of communication
 Multiple documents—coming in, going out
 Coordination of response if multiple respondents
 Capturing and tracking all available information related
to EACH grievance
 Easy access to information in case of surveyor inquiry
into a specific grievance
 Aggregating all of this into useful information for
management and leadership on a regular and routine
basis
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Special Challenges
 Grievances sent to “Administration” OR multiple
departments.
 Grievances involving physicians and other providers.
 Grievances received long after the patient has left.
 Writing follow-up response letters.
 HIPAA procedures when grievances are received from
“patient representatives” or “concerned” parties.
 Patient property losses or damage—are those
grievances?
 Grievances involving demands for money or threatening
litigation.
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Thank You Very Much
Questions?
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References
Bryan A. Garner, Black’s Law Dictionary (7th ed., West Group, 1999).
LANSA, CHRISTUS Health brings Transparency to Contract Management,
http://www.lansa.com/casestudies/Christushealth.htm (accessed April 3, 2009).
Roberta Carroll ed., Risk Management Handbook for Health Care Organizations
(4th ed., AHA Press 2004).
Joan A. Kavuru, JD, Informed Consent: Why Patients Sue – A Review of Recent
Litigation (A Presentation), http://www.ecu.edu/cs-dhs (accessed April 3, 2009).
ACS, Minimizing the Risk of Malpractice Claims, http://www.medscape.com/
viewarticle/507227_6 (accessed Feb. 22, 2008).
American College of Legal Medicine, Legal Medicine (3rd ed., Mosby, 1995).
Evert effort has been made to ensure the accuracy of the information provided
in this present sources were used that were believed to be credible, accurate,
and reliable. However, no guarantee or warranty with regard to the information
provided is made or implied.
The information contained in this presentation is not legal advice.
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Please Note
Every effort has been made to ensure the accuracy of the
information provided in this presentation. Only sources
were used that were believed to be credible, accurate, and
reliable. However, no guarantee or warranty with regard
to the information provided is made or implied.
The information contained in this presentation is not
intended to be medical or legal advice.
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