Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Compliance Update:
Challenged by the CMS Requirements
for Informed Consent?
Ensure Compliance with Healthcare’s
Most Complex Documentation
Taylor Healthcare Webinar Series
April 28, 2016
Timothy Kelly, MS, MBA
Webinar Objectives
• Review areas of compliance and mechanisms for surveys and
accreditation
• Examine symptoms of non-compliance
• CMS requirements for informed consent
‒ Policy
‒ Form
‒ Process
‒ Survey
• Recommendations
‒ Location of consent
‒ Concurrent surgery and multi-procedure surgery
‒ Items not mentioned by CMS
• References
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Compliance Update
Page 1 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Background - Compliance
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Compliance
• Requirements
‒ Medicare Conditions of Participation (CoPs)
‒ State-specific requirements
‒ Other standards
‒ Case law
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Compliance Update
Page 2 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
State Law
• Medical Disclosure
Panels
• Special Cases
• Emancipated Minors
• Minimum age for mental
health consent
• Surrogate and legal
representatives
Zia S, Egbuniwe NC. Lessons Learned:
Implementing a Digital Process for Informed
Consent. PS&QH. 2015;12(5):32-37.
http://viewer.zmags.com/publication/bc40b8
bc#/bc40b8bc/32 Accessed 4/26/16.
Texas Administrative
Code. Informed Consent.
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Case Law
• Example: Wisconsin
Supreme Court
expansion of the duty
to disclose diagnostic
options that may not
be fully supported by
the presenting
symptoms
Kelly T. What Wisconsin court ruling
on informed consent means to
states and ACOs. Government
Health IT. May 22, 2012.
http://www.govhealthit.com/blog/wha
t-wisconsin-court-ruling-informedconsent-means-states-and-acos
Accessed 4/26/16.
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Compliance Update
Page 3 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Compliance
• Survey/Accreditation Organizations
‒ State Survey Agencies
‒ CMS Regional Office
‒ The Joint Commission
‒ DNV
‒ HFAP
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DNV
• Deeming authority in 2008
• Have accredited almost
500 hospitals
• Integrates ISO 9001 with
the Medicare Conditions
of Participation
‒ Does require ISO 9001
certification
‒ Quality focus with
emphasis on
organizational
compliance with policy and procedures
Turnure E. DNV Accreditation Leads to Improving Informed Consent.
PS&QH. Sep/Oct 2012. http://psqh.com/dnv-accreditation-leads-toimproving-informed-consent Accessed 4/26/16.
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Compliance Update
Page 4 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Symptoms of Non-Compliance
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Deficient Consent Forms
• 157-hospital study
• Only 26 percent of forms
included all of the “basic
elements”
‒ Description of the
procedure
‒ Risks
‒ Benefits
‒ Alternatives
Bottrell MM, Alpert H, Fischbach RL, Emanuel LL.
Hospital informed consent for procedure forms:
facilitating quality patient-physician interaction.
Arch Surg. 2000;135(1):26-33.
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Compliance Update
Page 5 of 24 Taylor Healthcare Webinar Series
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CMS Requirements for Informed Consent
Consent Continues
to Pose Problems
• Consent was obtained
for an EGD but not the
two nasolaryngoscopy
procedures that may
have resulted in
complications that may
have contributed to her
death
• No consent for
observers/photography
Kelly T. Joan Rivers Lawsuit to Focus
Attention on Informed Consent. PS&QH.
February 6, 2015. http://psqh.com/psqhblog/joan-rivers-lawsuit-to-focus-attentionon-informed-consent Accessed 4/26/16.
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Poor Consent Form
Execution
•
•
•
•
•
Missing information
Illegible writing
Abbreviations
Version control
Provider-to-provider variation
Issa MM, Setzer E, Charaf C, et al. Informed versus
uninformed consent for prostate surgery: the value of
electronic consents. J Urol. 2006;176(2):694-9.
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Compliance Update
Page 6 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Errors and Omissions
• “During a recent CMS survey
at XXXXXXXX, the surveyors
found a couple deficiencies on
2 documentation items. The
surgical consent is a paper
form scanned into the record
after all signatures are
documented. This requires
manual dating and timing with
the signatures which was
missed by the providers on a
few cases.”
13
Lost or Misplaced Consents
• 66 percent of patients had the
consent missing from their
record at the time of surgery
• Delayed 10 percent of total
cases
Garonzik-wang JM, Brat G, Salazar JH, et al. Missing
consent forms in the preoperative area: a single-center
assessment of the scope of the problem and its
downstream effects. JAMA Surg. 2013;148(9):886-9.
Kelly T. New Research from Johns Hopkins – The Case of
the Missing Consent Form. PS&QH. August 27, 2013.
http://psqh.com/blog/new-research-from-johns-hopkinsthe-case-of-the-missing-consent-form Accessed 4/26/16.
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Compliance Update
Page 7 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
CMS Requirements
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General Comments
• Our focus will be limited to surgical/treatment consents
‒ CMS offers separate guidance on Advance Directives, privacy,
restraints, visitation, organ donation, tissue banking
• Information must be specific to the patient
‒ The right to make informed decisions means that the
patient or patient’s representative is given the information
needed in order to make "informed" decisions regarding
his/her care. Interpretive Guidelines §482.13(b)(2)
• Consent must be executed by the patients in writing
‒ Properly executed informed consent forms for procedures
and treatments specified by the medical staff, or by Federal
or State law if applicable, to require written patient consent.
Interpretive Guidelines §482.24(c)(4)(v)
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Compliance Update
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April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Policy
• Policy for informed consent must cover the following:
‒ Who may obtain the patient’s consent (which providers)
‒ Which procedures require informed consent
‒ Circumstances for no consent (emergent circumstances)
‒ Circumstances for when a patient’s representative my provide
consent
‒ Content of the form and instructions for completing it
‒ The process used to obtain informed consent, including how
informed consent is to be documented in the medical record
‒ Mechanisms that ensure that the informed consent form is
properly executed and is in the patient’s medical record prior to
the surgery (except in the case of emergency surgery)
Interpretive Guidelines §482.51(b)(2) – Surgical Services
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Policy
• Policy for informed consent must cover the following:
‒ If the informed consent process and informed consent form are
obtained outside the hospital, how the properly executed
informed consent form is incorporated into the patient’s medical
record prior to the surgery
‒ Any state-specific requirements
Interpretive Guidelines §482.51(b)(2) – Surgical Services
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Compliance Update
Page 9 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Form
• A properly executed informed consent form contains the following
minimum elements:
‒ Name of the hospital
‒ Name of the specific procedure(s) or type of medical treatment
‒ Name of the responsible practitioner who is performing the
procedure or administering the medical treatment
‒ Statement that the procedure or treatment, including the
anticipated benefits, material risks, and alternative therapies,
was explained to the patient or the patient’s legal representative
‒ Signature of the patient or the patient’s legal representative
‒ Date and time the informed consent form is signed by the
patient or the patient’s legal representative
Interpretive Guidelines §482.24(c)(4)(v) – Medical Records
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Form
• A well-designed informed consent form might also include:
‒ Name of the practitioner who conducted the informed consent
discussion
‒ Date, time, and signature of the person witnessing the patient or
the patient’s legal representative signing the consent form
‒ Indication or listing of the material risks of the procedure or
treatment that were discussed
‒ Statement, if applicable, that physicians other than the operating
practitioner, including but not limited to residents, will be
performing important tasks related to the surgery, in accordance
with the hospital’s policies and, in the case of residents, based
on their skill set and under the supervision of the responsible
practitioner
Interpretive Guidelines §482.24(c)(4)(v) – Medical Records
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Compliance Update
Page 10 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Form
• A well-designed informed consent form might also include:
‒ Statement, if applicable, that qualified medical practitioners who
are not physicians who will perform important parts of the
surgery or administration of anesthesia will be performing only
tasks that are within their scope of practice, as determined
under State law and regulation, and for which they have been
granted privileges by the hospital.
Interpretive Guidelines §482.24(c)(4)(v) – Medical Records
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Process
• A well-designed informed consent process would include discussion
of the following elements:
‒ A description of the proposed surgery, including the anesthesia
to be used
‒ The indications for the proposed surgery (reason for procedure)
‒ Material risks and benefits for the patient related to the surgery
and anesthesia, including the likelihood of each, based on the
available clinical evidence, as informed by the responsible
practitioner’s clinical judgment
‒ Treatment alternatives, including the attendant material risks
and benefits
‒ The probable consequences of declining recommended or
alternative therapies
Interpretive Guidelines §482.51(b)(2) – Surgical Services
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Compliance Update
Page 11 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Process
• A well-designed informed consent process would include discussion
of the following elements:
‒ Whether physicians other than the operating practitioner,
including but not limited to residents, will be performing
important tasks related to the surgery, in accordance with the
hospital’s policies
‒ Whether qualified medical practitioners who are not physicians
will perform important parts of the surgery or administer the
anesthesia, and if so, the types of tasks each type of practitioner
will carry out; and that such practitioners will be performing only
tasks within their scope of practice for which they have been
granted privileges by the hospital
Interpretive Guidelines §482.51(b)(2) – Surgical Services
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Process
• A well-designed informed consent process would include discussion
of the following elements:
‒ If residents will perform important parts of the surgery,
discussion is encouraged to include the following:
o That residents will perform portions of the surgery, based on their availability and
level of competence
o That it will be decided at the time of the surgery which residents will participate
and their manner or participation, and that this will depend on the availability of
residents with the necessary competence; the knowledge the operating
practitioner/teaching surgeon has of the resident’s skill set; and the patient’s
condition
o That residents performing surgical tasks will be under the supervision of the
operating practitioner/teaching surgeon
o Whether, based on the resident’s level of competence, the operating
practitioner/teaching surgeon will not be physically present in the same operating
room for some or all of the surgical tasks performed by residents
Interpretive Guidelines §482.51(b)(2) – Surgical Services
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Compliance Update
Page 12 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Survey
• Review policies and procedures
‒ Procedures that require informed consent
‒ When procedures may be considered emergent (no consent
required)
• Review a minimum of six non-emergent informed consent forms
‒ Will ideally review the records of patients who are about to
undergo surgery or who are located in a surgical recovery area
• Confirm presence in chart prior to surgery
• Interview two or three post-surgical patients, as appropriate based
on their ability to provide a cogent response, or the patients’
representatives, to see how satisfied they are with the informed
consent discussion prior to their surgery
Interpretive Guidelines §482.51(b)(2) – Surgical Services
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Recommendations
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Compliance Update
Page 13 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Recommendations
• Review your policy against the CMS guidelines
‒ If you place elements in your policy – mirror them on the
consent form to provide verification of completion
‒ Then evaluate your processes against your policy
‒ Interview patients (your surveyors will)
27
Two Ideas
1. Electronic Informed Consent
‒ 96 percent of patients preferred procedure-specific electronic
consent to traditional fill-in-the-blank consent
2. Employ Teach-Back
‒ 575-subject, 7-site
randomized controlled trial
‒ Improved comprehension
and satisfaction
‒ Required only 2.6 additional
minutes
Issa MM, Setzer E, Charaf C, et al. Informed versus
uninformed consent for prostate surgery: the value of
electronic consents. J Urol. 2006;176(2):694-9.
Fink AS, Prochazka AV, Henderson WG, et al. Enhancement
of surgical informed consent by addition of repeat back: a
multicenter, randomized controlled clinical trial. Ann Surg.
2010;252(1):27-36.
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Compliance Update
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April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Recommendations
• Pay special attention to your policies along with disclosure and
documentation of:
‒ Concurrent/overlapping procedures
‒ Use of residents
‒ Use of assistive personnel
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Concurrent Surgery
• Boston Globe series spurs Senate
review and inquiry
• Watch the American College of
Surgeons for new guidance
Boston Globe.
April 13, 2016.
Pittsburgh PostGazette.
March 28, 2016.
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Compliance Update
Page 15 of 24 Taylor Healthcare Webinar Series
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CMS Requirements for Informed Consent
Recommendations
• Automate your consent process to:
‒ Establish version control
‒ Prevent errors and omissions
‒ Ensure that the consent is present in the medical record
31
Preventable Issues
• Version control
• Consent expiration
• Documentation of an
interpreter
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Compliance Update
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CMS Requirements for Informed Consent
Date and Time
• Four specific consent forms
are cited as lacking date and
time or the time of signature
CMS. Statement of Deficiencies and Plan of
Correction. Survey Completed 12/04/2012.
33
OR Start Time Delays
• Missing or problematic consents
had a negative impact upon OR
start times in 46 percent of
cases
• Declined to less than 1 percent
of cases with implementation of
an electronic informed consent
process
Sanchez E. SAMMC earns fourth 'Most Wired‘. DVIDS.
July 17, 2015.
https://www.dvidshub.net/news/170335/sammc-earnsfourth-most-wired#.Vx-HRPkrJhH Accessed 4/26/16.
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Compliance Update
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CMS Requirements for Informed Consent
Recommendations
• Establish policies and procedures for obtaining informed consent
outside the walls of your institution:
‒ Ensure that your consent documentation process operates
seamlessly in remote physician offices
35
Where to Obtain Consent
• In malpractices cases, alleging
inadequate informed consent,
consents obtained in the preoperative holding area,
compared to in the surgeon’s
office, resulted in significantly
higher legal expenses and
indemnity payouts
‒ $322,000 higher, on
average, for the orthopedic
procedures studied
Bhattacharyya T, Yeon H, Harris MB. The medical-legal
aspects of informed consent in orthopaedic surgery.
J Bone Joint Surg Am. 2005;87(11):2395-400.
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Compliance Update
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CMS Requirements for Informed Consent
Recommendations
• Ensure that you have a policy and process to document consent for
multiple procedures.
‒ Ensure also that you obtain and document consent for
foreseeable or “possible” procedures that may be performed
based on intraoperative findings
37
Possible Procedures
• When possible procedures
can be anticipated, it is
best to document those
surgical options with
specificity rather than
relying on an ambiguous,
non-specific legal
boilerplate
‒ Example: Exploratory
Laparotomy with
possible
Appendectomy and
possible
Cholecystectomy
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Compliance Update
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CMS Requirements for Informed Consent
Recommendations
• Pay attention to anesthesia consent – CMS is relatively non-specific
in this area
• Add a blank or space to capture surgical site on your consent
39
Avoiding Errors
• An instance of
wrong-patient/
wrong-procedure/
wrong-site
surgery reaches a
patient, on average,
once per year in a
300-bed hospital
Clarke JR, Johnston J, Finley ED. Getting
surgery right. Ann Surg. 2007;246(3):395-403.
The Detroit News.
May 7, 2015.
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Compliance Update
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CMS Requirements for Informed Consent
Avoiding Errors
• The most effective
mechanism for avoiding
wrong-patient/wrongprocedure/wrong-site
surgery is verification of
the consent form.
‒ 30-month study of all
hospitals in
Pennsylvania
Clarke JR, Johnston J, Finley ED. Getting
surgery right. Ann Surg. 2007;246(3):395-403.
41
Failure to Verify
• "...the Surgical Fellow
proceeded to perform the
DIP fusion on the patient's
distal middle right finger,
instead of the small finger
per the Surgical Consent
signed by the patient..."
Rhode Island Department of Health. Statement
of Deficiencies and Plan of Correction. Survey
Completed 10/28/2009.
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Compliance Update
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CMS Requirements for Informed Consent
Final Example
• Patient with a femoral
neck fracture
43
Added Two Sections
• Procedure description
• Surgical site
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Compliance Update
Page 22 of 24 Taylor Healthcare Webinar Series
April 28, 2016 1:00pm EST
CMS Requirements for Informed Consent
Recommendations
• Employ the consent during the verification of patient, procedure and
surgical site
• Do not overlook the benefits of automation to ensure compliance
45
Questions
Timothy.Kelly@TaylorCommunications.com
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Compliance Update
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CMS Requirements for Informed Consent
References
• State Operations Manual (Rev. 151, 11-20-15)
‒ §482.13 Condition of Participation: Patient's Rights
‒ §482.24 Condition of Participation: Medical Record Services
‒ §482.51 Condition of Participation: Surgical Services
• Consent to Treatment: A Practical Guide, Fifth Edition
‒ Fay Rozovsky, JD, MPH
‒ Wolters Kluwer (updated annually, last update 12/07/15)
• Department of Veterans Affairs Policy for Informed Consent
‒ VHA Handbook 1004.05
‒ December 10, 2014
• iMedConsent.com
‒ Slides from this webinar, other presentations, articles,
links to references
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Compliance Update
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