Transcript JC 2011 PATIENT RIGHTS - Arkansas Hospital Association

Joint Commission Patient Rights
What every hospital should know.
Speaker
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
President
Patient Safety and Healthcare
Education
5447 Fawnbrook Lane
Dublin, Ohio 43017
614 791-1468
[email protected]
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Patient Rights
 Will discuss the following:
 CMS patient rights guidelines
 TJC brochure on patient rights
 TJC tracer questions on patient rights
 Patient rights as one of the 14 priority focus
areas
 TJC standards on patient rights
 TJC has 3 FAQs on patient rights
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RI Chapter
 Rights and responsibilities of the Individual and
abbreviated RI Chapter
 The Joint Commission
 Will refer to as TJC and not called JCAHO anymore
 Patient rights is important with both TJC and CMS
and TJC has made changes
 TJC eliminates RI.01.06.05 EP1 July 1, 2010
 New change 2011 on patient centered communication
which was previously called patient provider
communication
 CMS has a patient rights chapter which is extensive
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Patient Provider Communication RI.01.01.01
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Jan 1, 2011 Patient Centered Communication
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CMS CoP Hospital Patient Rights
 Remember that most hospitals accept Medicare
and as such must follow the CMS Hospital CoPs
 So hospital must follow these for all patients not
just Medicare or Medicaid patients
 Include both in your P&Ps
 Exception is the CAH (Critical Access Hospitals) do not
have a patient rights section except will add visitation and
QIO/State agency notification
 CMS has a patient rights section
 Includes 50 pages of restraints interpretive guidelines
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The Revised Final CoPs
 Final interpretive guidelines were published June 5,
2009
 Anesthesia ones changes December 30, 2009 and February 5, 2010,
May 21, 2010 and February 14, 2011
 Respiratory and Rehab orders updated October 1, 2010
 Visitation regulations effective Jan 18, 2011 but interpretive guidelines
not out yet
 Has section on grievances, patient rights, and advance
directives
 Every hospital should have a copy of this!!!
 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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The Conditions of Participation
First published in the Federal Register-42 CFR Part 482.
Federal Register available at
http://www.gpoaccess.gov/fr/index.html
Then CMS takes and adds their directions on how to survey
these in the Interpretive Guidelines and some have survey
procedures,
Should check the below website once a month to check for
changes
Changes on Survey and Certification website at
www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp
Also some changes at Transmittals at
www.cms.gov/Transmittals/01_overview.asp
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CMS Survey & Certification Website
www.cms.hhs.gov/SurveyCertification
GenInfo/PMSR/list.asp
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CMS Patient Rights Standards 0116-214
CMS Patient Rights include:
 Right to notification of rights and exercise of rights
 Privacy and safety
 Confidentiality of medical records and
 Restraint issues
 QIO and state agency notification
 Visitation rights
 These establish minimum protections and rights for
patients
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TJC Patient Rights
 Many changes in 2009 as part of the Standards
Improvement Initiative (SII) which continue into 2011
 There are 14 (from 24) standards in the TJC RI
chapter
 There are 91 elements of performance (one deleted
July 2010 and one added 2011
 TJC is committed to protecting the rights and dignity
of all patients
 Must treat patients as individuals with unique
personal and health needs
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TJC Patient Rights Overview
 Patients need to be actively encouraged to be
involved with decisions about their care
 Empowered patients ask more questions and
develop better relationships with their caregivers
 The acknowledgement of patient rights helps
patients feel more supported by the hospital and
staff involved with their care
 Patients have an obligation to take on certain
responsibilities
 These are defined and relayed to the patients
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TJC Patient Rights Overview
 TJC, unlike CMS, has patient obligations and
responsibilities
 Mere list of rights does not itself guarantee those
rights
 Hospital must show its support of patient rights in
the actions it takes
 Hospitals need to make sure patients are informed
of their rights
 Hospitals must help patient to understand their
rights and exercise their rights
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TJC Rights Include
 The right to effective communication
 The right to participate in care decisions
 The right to informed consent
 The right to know care providers
 The right to participate in end-of-life decisions
 Individual rights of patients
 Patient responsibilities
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Overview of TJC RI Chapter
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TJC Revised Requirements
 Recall discussion that Mar 26, 2009 TJC
issues 27 pages of changes to the TJC
hospital manual that continue into 2010,
Will discuss the changes made
TJC has a flier on the speak up program
encouraging patients to know their rights at
www.jointcommission.org/PatientSafety/SpeakUp/,
,
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TJC Changes to Comply with CMS CoPs
 RI.01.01.01.01 when patients request access to
medical record information, hospital need to provide
as quickly as record keeping system allows
 RI.01.02.01 patient has a right to have family
member notified of admission to hospital and to
have own physician notified (even if not the
admitting physician)
 RI.01.05.01 the hospital defines how it obtains and
documents permission to perform an autopsy,
 RI.01.07.01 Grievances and now 20 EPs
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TJC Know Your Rights Brochure
 TJC has a flier on the speak up program
encouraging patients to know their rights at
 http://www.jointcommission.org/speakup.aspx
 It is called “Speak Up Know Your Rights”
 Issued March 15, 2011
 Discusses questions for patients to ask their doctor
 Discusses what are the patient’s rights
 Discusses having a patient advocate to stay with
them, consent, how to file a complaint etc.
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TJC Know Your Rights Brochure
www.jointcommission.org/speakup.aspx
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FAQ on Patient Rights
TJC has 3 topics under FAQs on RI
 Organ donation one but this standard is now in
the Transplant chapter
 Filming and recording
 Patient rights and informed consent when
videotaping or filming
 All revised November 24, 2008
– at
www.jointcommission.org/standards_information/jcfaq.
aspx
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3 FAQs on Rights and Responsibilities
These will be covered under the standards
http://www.jointcommission.org/standards_information/jcfaq.aspx
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Filming And Recording FAQ
 Q: Standard RI.01.03.03 EP 7 states;
 Before engaging in recording or filming anyone
who is not already bound by the hospital's
confidentiality policy, signs a confidentiality
statement to protect the patient's identity and
confidential information
 Does this mean that we need to have media sign a
confidentiality agreement even if the patient has
consented to be filmed/recorded?
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Filming And Recording FAQ
 A: No. EP 7 is only applicable in those circumstances in
which filming/recording intended for external use is
being done without patient consent.
 In that situation, the party filming the images should
sign a confidentiality agreement indicating that they will
not show the film/photos until consent is obtained from
the patient. If consent is not obtained, the identity of the
patient will be masked or the film will be destroyed.
 If the patient has specifically consented to being
filmed/recorded prior to the commencement of filming,
the media or party doing the filming does not need to
sign a separate confidentiality agreement.
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Consent When Videotaping or Filming
Q: Can staff or their designated agent film
or videotape patient care activities in the
Emergency Department?
Yes; see full answer following below
A: Yes. It is appropriate to film or videotape
patient care activities in the ED, provided
patients or their family members or
surrogate decision makers give informed
consent.
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FAQ on Videotaping and Consent
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Patients Right is One of 14 PFAs
 TJC has 14 priority focus areas
 Right to an appropriate level of care or service
 Right to receive safe care
 Respect for cultural values and religious
beliefs
 Privacy and confidentiality of information
 Recognition and prevention of potential abuse
situations
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Patients Have the Right To
Notification of unanticipated outcomes
Involvement in care decisions
Information on risks and benefits of
investigational studies
End of life care
Advance directives
Organ procurement
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Patients Have the Right
 A right to have advance directives and to have them
followed
 Freedom from unnecessary restraints
 Informed consent for various procedures
 The right to refuse care
 Right to have their pain believed and relieved
 Communication with administration
 To chose their visitors
 And education
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Individual Tracers Patient Rights
 Not a hospital program specific tracer like patient flow
or suicidal prevention
 However, TJC 2011 Survey Guide states patient
rights tracer is done as part of the individual tracer
 When surveyor interviews patients and families
 Things surveyor may look at or observe
 Staff discussion and observation on communication
between shifts and departments,
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Individual Tracers Patient Rights
 Surveyor to talk with staff about the following and
to observe these during the survey process;
 Communication between shifts and departments
 Education within the confines of patient needs,
physical and cognitive challenges, culture and
language diversity
 Use of restraint and seclusion
 Process when a patient refuses care
 Process to inform family, surrogate, or another
physician of admission when requested by patient
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Individual Tracers Patient Rights
 Surveyor is instructed to interview the patient and
the family to determine their understanding of the
following;
 Rights, prior to receiving or discontinuing care
 This includes advanced directive and end of life
decisions
 Patient safety and personal and health information
privacy
 Hospital would want to make sure that white boards with
things such as patient names and diagnosis are not visible
to the public
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AHA Patient Rights
 A different AHA document replaces the AHA's
Patients' Bill of Rights
 It is called “The Patient Care Partnership:
Understanding Expectations, Rights and
Responsibilities”
 It is a plain language brochure that informs patients
about what they should expect during their hospital
stay with regard to their rights and responsibilities
 The brochure is available in eight languages
 http://www.aha.org/aha/issues/CommunicatingWith-Patients/index.html
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AHA Patient Rights Brochure
http://www.aha.org/aha/issues/Communicating-With-Patients/index.html
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AHA Patient Rights Booklet
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AHA Patient Rights Expectations
High quality care
Clean and safe environment
Discussing your medical condition
Information about medically appropriate
treatment choices
Discussing your treatment plan
Right to get information from the patient
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AHA Patient Rights Expectations
Understanding who can make decisions if
you can not
Involvement in your care
Protection of patient privacy
Help with bill and filling insurance claims
Preparing for discharge
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RI.01.01.01 Respecting Patient Rights
The standard: The hospital respects,
respects and promotes patient rights
EP1 There are written P&P on patient rights
EP2 Patients are informed of their rights
EP4 Patients are treated in a dignified and
respectful manner
EP5 The patients rights to and need for
effective communication must be respected
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RI.01.01.01 Respecting Patient Rights
EP6 Patients cultural and personal values,
beliefs, and preferences are respected
EP7 Right to privacy is respected
Discusses personal right to privacy
 See also IM.02.01.01, EP1-5 which requires
the hospital to protect the privacy of health
information, to have a P&P on this, and to
disclose information only as permitted by
law
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RI.01.01.01 Respecting Patient Rights
EP8 Right to pain management is respected
EP9 Patient right to religious and spiritual
service is accommodated by the hospital
EP10 Patients are allowed to access, request
amendment, and obtain information on
disclosures about their health information
 As allowed by law and regulation,
New EP 28 and 29 in 2011 on patient
centered communication
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RI.01.01.01 Respecting Patient Rights
 EP 28 A family member,friend, or other individual to
be allowed to be present with the patient for emotional
support during the course of stay
 Unless the presence infringes on others' rights, safety
 Unless it is medically or therapeutically contraindicated
 The person may or may not be the patient's surrogate
decision-maker or legally authorized representative
 EP 29 Discrimination based on age, race, ethnicity,
religion, culture, language, physical or mental
disability, socioeconomic status, sex, sexual
orientation, and gender identity or expression is
prohibited
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RI.01.01.01 Respecting Patient Rights
 These first new EPs will not be counted against the
hospital until January of 2011 and the visitation one
became effective July 1, 2011
 CMS has passed a federal regulation effective January
19, 2011
 The regulation requires you to give the patient, in
writing, information about visitation
 This must be documented in the medical record
 For example, if you limit visitors in the ICU to two, this
would be permitted, but patient gets to pick the two
people such as a same sex partner or best friend
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2011 Changes MR Must Contain
 New in 2011 to improve patient centered
communication
 Qualifications for language interpreters and
translators will be met through proficiency,
assessment, education, training, and experience
 Hospitals need to determine the patient’s oral and
written communication needs and their preferred
language for discussing health care under PC
standard
 Hospital will communicate with patients in a
manner that meets their communication needs
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2011 Changes MR Must Contain
 Hospitals required to collecting race and ethnicity
data under RC.02.01.01 EP1
 Patients should self report so patient states she is white
and Albanian
 Collecting language data under RC.02.01.01 EP1
 The patient’s communication needs, including
preferred language for discussing health care
 If the patient is a minor, is incapacitated, or has a
designated advocate, the communication needs of the
parent or legal guardian, surrogate decision-maker, or
legally authorized representative is documented in the MR
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RI.01.01.01 Respecting Patient Rights
CMS in the hospital CoPs also has a section
on patient rights
Make sure you have a written P&P on patient
rights
Give patients a written copy of their rights
Can include patient rights on back side of
general consent form and notice of privacy
practice that all patients sign on admission or
for outpatient treatment
Communication with patient is important
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What Does This Standard Mean?
 Form can say I hereby acknowledge that I have
received a written copy of my patient rights
 Accommodate the right to pastoral or other spiritual
services
 Resources to recognize and address pain
 Educate staff and providers about pain
 Document pain assessment and relief of pain
 HIPAA requires hospitals to have a policy and
procedure in which a patient can request an
amendment of their medical record if they believe
there is a mistake
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RI.01.01.03 Respecting Patient Rights
 Hospitals and other healthcare facilities will encounter
more patients with language barriers as our country
becomes more diverse
 Hospitals must have language access services for
translators and interpreters to meet the communication
needs of patients
 Communication is a critical part of patient safety and
risk management
 This is what lead the Joint Commission to adopt five
standards in four different chapter on patient centered
care to ensure patient provider communication
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RI.01.01.03 Respecting Patient Rights
 Communication is the cornerstone of patient safety
and quality
 Effective communication allows the patient to
participate more fully in their care
 Good communications prevent medical errors
 Communicating is critical during the informed
consent
 There are 50 million people in this country whose
English is not their primary language
 Low health literacy is another important issue
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RI.01.01.03 Respecting Patient Rights
 Many patients way require alternative
communication methods
 Patients who speak other languages than English
 Patients with limited literacy in any language
(LEP)
 Patient with visual or hearing impairments or on
ventilators
 Hospitals needs interpreters and translated written
material
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Interpreters Are Required by Law
 Title VI of Civil Rights Act
 Executive Order 13166
 Policy guidance from the Office of Civil Rights
regarding compliance with Title VI, 2004
 Title III of the Americans with Disabilities Act, 1990
 State laws (many states have laws and regulations
that require the provision of language assistance)
and the American Medical Association Office
Guide to Limited English Proficiency (LEP) Patient
Care
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RI.01.01.03 Right to Receive Information
 Standard: The patient had the right to receive
information in a manner she will understand
 EP1 The information provided to the patient needs to
be tailored in a way the patient can understand
considering age, language and their ability to
understand
 EP2 Language interpreting and translation services
are provided by the hospital
 EP3 Information is provided to the patient who has
vision, speech, hearing, or cognitive impairments
 This must be provided in a manner that meets the
patient’s needs
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What Does This Standard Mean?
 Patients need to receive information in a manner
they can understand and use
 Issue of low health literacy
 Written material should be appropriate to age and
understanding of patient
 Need to address needs of those with vision, speech,
hearing or language problems
 Post sign for interpreting services in different
languages and that they are available at no charge
 Interpreting services need to be provided and be sure to
document in the medical record
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What are Surveyors Looking For?
 The hospital has a P&P on language access
services
 That staff are oriented and trained in the P&P
 That language access is used at the critical times or
points of care and staff know how to access these
 That staff and physicians understand the patient
has the legal right to interpreting and translation
services
 How the hospital designed the program and addition
to their demographics with the population served
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What are Surveyors Looking For?
 Surveyors will observe if staff follow the P&P to make
sure patients communication needs are met
 May do as part of a tracer and select a patient who
does not speak English
 What is the hospital’s plan for language access,
accessibility and that it is in good working order
 Make sure bilingual staff have training on how to be an
interpreter
 Do not use a child to interpret and family members
 Exception for family members if patient insists, get it in writing, use
interpreter to obtain, make sure knows at no expense to the patient
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What are Surveyors Looking For?
 Will make sure patients are informed about their
rights and consider posting sign
 Will verify there is documentation about the use of
an interpreter
 Will verify that there is documentation about the
patient’s preferred language for discussing health
care
 That race and ethnicity data is collected in the MR
 Will assess if the patient uses any assistive devices
and these were used to help the patient
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What are Surveyors Looking For?
 Consider providing patient rights materials in
multiple language along with other important
documents for patient population served
 Understand when person is qualified and when
certified to be an intepreter
 Identify patient cultural, religious, or spiritual beliefs
and practices that influence care
 The Roadmap for Hospitals has a number of
excellent recommendations for ensuring a quality
interpreting and translation program
 This is available at no charge
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Advancing Effective Communication Roadmap
 Advancing Effective Communication, Cultural
Competence, and Patient- and Family-Centered
Care: A Roadmap for Hospitals is a monograph
developed by TJC
 To help hospitals incorporate concepts from the
communication, cultural competence, and patientand family-centered care fields into their facility
 The Roadmap will help hospitals to comply with the
patient-centered communication standards
 Has educational tools
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Communication Roadmap
 Includes information on the law
 Includes model policies
 Includes a self assessment guide
 Provides examples for each standard
 Roadmap Updated August 2010
 See also Hospitals, Language, and Culture A Snapshot of
the Nation
 See One Size Does Not Fit All: Meeting the Healthcare
Needs of Diverse Populations
 Available at http://www.jointcommission.org/patientsafety/hlc/
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Study Finds Few Hospitals in Compliance
 Study published February 14, 2011 finds few
hospitals in compliance with the TJC standards on
patient centered communication
 Lack of compliance with language access
requirements for limited English proficiency (LEP)
 Communication breakdowns are responsible for
3,000 unexpected death every year
 Standards to improve patient provider
communication and ensure patient safety
 "The New Joint Commission Standards for Patient-Centered Care," report
can be found at http://www.languageline.com/jointcommission2011report
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Topics Covered in the White Paper
 Language challenges that impact healthcare
 Why language services are critical
 The unfortunate truth: most hospitals are not
compliant
 The origins of medical interpreting
 Patient/provider understanding and acceptance
 Joint Commission mandates for training and
certification
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Topics Covered in the White Paper
The standards that apply to language access
services
The consequences of non-compliance
Developing a system-wide language services
program
The Joint Commission is serious
Hospitals CAN prepare themselves
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TJC R3 Report
http://www.jointcommission.org/R3_issue1/
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OIG Examines Provisions of Language Services
 Medicare Improvements for Patients and Providers
Act of 2008 requires survey of hospitals and others
with high number of limited English proficient
individuals (LEP)
 Only 2/3 of hospitals use the Office of Civil Rights four
factor assessment to determine which language services
are appropriate for a patient
 Only 33% of providers offered services consistent with
the Office of Minority Health's Culturally and Linguistically
Appropriate Services in Health Care voluntary standards
 Report OEI-05-10-00050 issued July 2010 at www.oig.hhs.gov
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TJC Video Improving Patient-Provider Communication
 The Joint Commission and the HHS Office of Civil
Rights has a resource that hospitals should be
aware of at www.jointcommission.org
 It is a 31 minute video on how to improve patientprovider communication
 It is available at no charge
 Initially standard referred to as patient-provider
communication
 More recently referred to as patient-centered
communication
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www.hhs.gov/ocr/civilrights/resources/specialtopics/hospit
alcommunication/ecinfo.html
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www.hhs.gov/ocr/civilrights/resources/specialtopics/hospit
alcommunication/index.html
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RI.01.02.01 Right to Participate in Decisions
Standard: the patient has a right to
participate in decisions about their care and
treatment
Right is not to be construed as mechanism to
demand medically unnecessary care (DS)
EP1 Patient is involved in decision making
about their care and treatment
 Including right to have own physician notified
promptly upon admission
76
RI.01.02.01 Right to Participate in Decisions
EP2 Patient is provided with written
information on their right to refuse care
as allowed by law
EP3 Hospital respects the patient’s right
to refuse care as allowed by law
EP6 Surrogate decision maker is used if
patient is unable to make decisions
about care and treatment
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RI.01.02.01 Right to Participate in Decisions
EP7 When surrogate decision maker is
responsible for care the hospital must respect
their decision to refuse care (changes)
 EP8 Family is involved in care when
permitted by the patient or the surrogate
decision maker, as allowed by law
EP20 Patient is provided information about
outcomes of care that the patient needs in
order to participate in their current and future
health care decisions
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RI.01.02.01 Unanticipated Outcomes
EP21 Patient or surrogate decision maker is
informed about unanticipated outcomes (UO)
of care that related to reviewable sentinel
events
 TJC sentinel event chapter has definition of reviewable
sentinel event
EP22 LIP is responsible to manage patient
care and inform about UO related to sentinel
event if patient is not already aware of this
 Where further discussion is needed
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What Does This Standard Mean?
 Document patient involvement in decisions
about their care
 CMS has a similar provision in allowing patients
to participate in decisions about their care
 Patients get informed consent, are involved in
pain management decisions, and in formulating
advance directives
 Competent adults can refuse care but needs to
be educated right so they know the risks and
benefits,
 Recommend you get it in writing
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What Does This Standard Mean?
 Parent usually consents for minor child
 If patient is incompetent document legal
guardian or DPOA
 Surrogate decision maker steps into shoes of
incompetent patient
 Have P&P on unanticipated disclosure
 Educate all staff on P&P
 Consider disclosure coaches
 Document discussion with patient
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National Patient Safety Foundation
 “Talking to patients about Health Care Injury.”
 Available at http://www.npsf.org,
 When a health care injury occurs, the patient and the
family or representative is entitled to a prompt
explanation of how the injury occurred and its short and
long-term effects. When an error contributed to the
injury, the patient and the family or representative
should receive a truthful and compassionate
explanation about the error and the remedies
available to the patient.
 They should be informed that the factors involved in the
injury will be investigated so that steps can be taken to
reduce the likelihood of similar injury to other patients.
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ASHRM 4 Documents
20 page document titled "perspective on disclosure of
unanticipated outcome information”
Provides examples of UO Policy and procedures
Has additional 3 documents, Disclosure: What works
now and what can work even better,
Disclosure: Creating an effective patient communication
policy, and
Disclosure: the next step in better communications with
patients
At http://www.ashrm.org/ashrm/resources/monograph.html
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RI.01.03.01 Informed Consent
Standard: the hospital must honor the
patient’s right to give or withhold informed
consent
EP1 Need written P&P on informed consent
EP2 Policy identifies the care or treatment
that requires informed consent as required
by law
EP3 Written policy describes exceptions to
getting consent
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RI.01.03.01 Informed Consent
EP4 Policy describes the process used to
get consent
 Remember informed consent is a process
 It is not just a form
EP5 P&P describes how consent is to be
documented
 Documentation must be in a form, progress note,
or elsewhere in the medical record
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RI.01.03.01 Informed Consent
EP6 P&P describes when surrogate decision
maker can give consent
 References RI.01.02.01, EP 6
 For example patient is incompetent and has a
guardian appointed or a durable power of
attorney for healthcare
 Parents make decisions for their two year old
child
EP7 Consent process includes discussion
about the proposed care and treatment
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RI.01.03.01 Informed Consent
EP9 Consent includes discussion of potential
benefits, risks, and side effects of the
proposed care
 The likelihood of the patient achieving her goals,
and
 Any potential problems that might occur during
the recuperation
EP11 Consent process includes discussion
about reasonable alternatives, and the risks,
benefits, and side effects of the alternatives
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RI.01.03.01 Informed Consent
EP12 Consent process included discussion
of any circumstances under which
information about the patient must be
disclosed or reported
 Would include reports to the department of health
or the CDC regarding cases of HIV, TB, viral
meningitis, or other things required
EP13 Consent is obtained in accordance with
Hospital P&P prior to surgery unless an
emergency
88
What Does This Standard Mean?
 CMS has 3 sections on informed consent in the
hospital CoPs
 Remember your state law on consent
 Have a written P&P on consent
 Make sure staff are aware of policy
 Need list of all surgeries and procedures with yes
or no if consent needed
 Make sure documented in medical record
 Consent on chart before surgery except in
emergencies
89
What Does This Standard Mean?
 Policy must include exceptions
 Policy must include when surrogate decision
maker signs (incompetent patient and guardian
or DPOA)
 Make sure includes all required elements from
TJC, CMS, and state law (alternatives, risks,
benefits, etc.)
 Make sure staff and physicians understand and
document conversation with patients about
mandatory reporting laws (HIV, STD, TB, viral
meningitis etc.)
90
Consider List of Procedures
Procedure Name
Requires Informed Consent
Ablations
Yes
Amniocentesis
Yes
Angiogram
Yes
Angiography
Yes
Angioplasties
Yes
Arthrogram
Yes
Arterial Line insertion (performed alone) Yes
Aspiration Cyst (simple/minor)
No
91
Informed Consent Manual
 One hospital (Providence Everett Medical Center)
has their informed consent manual on the Internet1
 It has an excellent list of which procedures need
informed consent
 List can be used by others to determine which
procedures they want to have informed consent
 Link with MS Office on what procedures are being
done in your facility
 Remember procedures with reasonable known
risks should be considered
1 http://www.lucidoc.com/cgi/doc-gw.pl/ref/pemc_p:10127
92
Informed Consent Forms
 Need for all surgeries except in emergencies
 All inpatients and outpatients
 For all procedures specified
 Needs to reflect a process
 Form must follow policies
 Must include state or federal requirements
 Must contain minimum requirements (mandatory)
 CMS has 6 mandatory issues for consent and
optional ones called well designed
93
Resources
 A site for consent forms that list the risks, and
complications, and alternatives of many
procedures (provided by the Queensland
Government.)1
 They have forms for pediatrics, orthopedics,
vascular, urology, surgical, renal, plastic surgery,
psychiatry, ophthalmology, maxillofacial, medical
imaging, neurosurgery, ear, nose and throat and
many more.2
1
http://www.health.qld.gov.au/informedconsent/ConsentForms/14025.pdf
2
http://www.health.qld.gov.au/consent/html/for_clinicians.asp
http://www.health.qld.gov.au/consent/
94
95
www.health.qld.gov.au/consent/
www.health.qld.gov.au/consent/
96
97
www.mnpatientsafety.org/index.php?option=com_conten
t&task=view&id=85&Itemid=69
98
99
www.hhs.gov/forms/HHS-687.pdf
100
So What’s In Your Policy?
101
So What’s In Your Policy?
102
RI.01.03.03 Recordings and Consent
 Standard: Patient has the right to give or withhold
consent to use films, photographs, recordings,
video, or other images for purposes other than his
care
 EP1 Hospitals may occasionally make a recording
or film or other image of a patient for internal use
other than for identification or diagnosis
 Such as for PI or education
 Need to obtain and document consent prior to
producing this
103
RI.01.03.03 Recordings and Consent
 EP2 When photograph, filming etc is used for external use
you need the patient’s consent before you do this
 Consent must include a discussion of how the photo or
film is going to be used
 These are commercial filming, TV programs, or marketing
material
 EP3 If patient unable to give consent for filming
then it may occur as permitted by your written P&P
 Which is established thru an ethical mechanism
like the ethics committee and that might include
community input
104
RI.01.03.03 Recordings and Consent
EP4 If the patient is unable to give consent
then the film or photograph is held in the
hospital’s possession
 And it is not used for any purpose until consent is
obtained
EP5 The hospital must destroy the film or
photograph if the patient’s consent can not be
subsequently obtained when the patient is
unable to give the consent
105
RI.01.03.03 Recordings and Consent
EP6 Patient needs to be informed of the right
to stop production of the recording or film
EP7 Anyone who is not bound by the
hospital’s confidentiality policy must sign a
confidentiality statement
 This is done to protect the patient’s identity and
confidential information
 This must be done before the filming or
production starts
106
RI.01.03.03 Recordings and Consent
EP8 The organization accommodates the
patient's right to rescind consent before the
recording, film, or image is used
The American Health Information
Management Association (AHIMA) has a
practice brief on Patient Photography,
Videotaping and other Imaging
It is available at
http://library.ahima.org/xpedio/groups/public/documents/ahima/bok2_00
0585.hcsp?dDocName=bok2_000585
107
AHIMA.org
108
Sample Consent
109
Be Aware of Your Hospital Policy
110
RI.01.03.05
Research
 Standard: Patient’s rights during research,
investigation, and clinical trials is protected
 EP1 Research protocols must be reviewed
 This includes weighing the risks and benefits to the patient
participating in the research
 EP2 The patient must be provided with the following
to decide whether to participate or not in the research
 Explanation of the purpose of the research
 Expected duration or how long it will last
 Description of the procedures to be followed
111
RI.01.03.05 Research
 Statement of the potential benefits, risks,
discomforts, and side effects
 Alternatives that might be advantageous
 EP3 Patient is informed that refusing to
participate or discontinuing participation will not
jeopardize his access to care unrelated to the
research
 EP4 The following must be documented in the
consent form
 That the patient received information to help
determine whether to participate or not,
112
RI.01.03.05 Research
EP5 The hospital documents the following in
the research consent form:
 That the patient was informed that refusing to
participate in research, investigation, or clinical
trials
 or discontinuing participation at any time will
not jeopardize his or her access to care
 treatment, and services unrelated to the
research
113
RI.01.03.05 Research
EP 6 The name of the person who
provided the information and the date the
form was signed must be documented
EP7 Consent form describes right to
privacy, confidentiality and safety
EP9 Hospital keeps all information given
to the patient in the medical record or
research file along with the consent forms
114
RI.01.04.01 Persons Responsible for Care
Standard: patient has a right to information
about the individuals responsible for
providing care and treatment
 EP1 Patient is informed of the name of the
physician and other practitioners who have
primary responsibility of the patient’s care
 EP2 Patient is informed of the name of the
physician, clinical psychologist, or other
practitioners who will provide their care
115
What Does This Standard Mean?
Patients have the right to know the name of
their physician or LIP
Introduce yourself to the patient at the first
interaction
Name tags or name embroider on lab coat
If the patient is incompetent then information
can be given to the surrogate decision maker,
parent, guardian, DPOA
116
RI.01.05.01 End of Life Care
Standard: Patient decisions are addressed
about care that will be received at the end of
life
 EP1 Must have P&P on advance directives,
foregoing or withdrawing life sustaining treatment,
and withholding resuscitation
 Must be in accordance with law or regulation
 EP4 The hospital has a written P&P on whether
they will honor AD in the outpatient setting
 Must decide if will honor in any of the OP settings
117
RI.01.05.01 End of Life Care
 EP5 Hospital must implement its AD P&Ps
 EP6 Patients are provided information in writing
about AD, foregoing or withdrawing life sustaining
treatment and withholding resuscitation
 EP8 Hospital provides information to the patient
upon admission to the extent the hospital is able
and willing to honor advance directives
 EP9 Must document if patient has AD
 EP 10 Hospital refers patient to resource to assist
in formulating ADs upon request
118
RI.01.05.01 End of Life Care
 EP11 Staff and LIPs must be aware of whether
or not the patient has an AD
 EP12 Hospital honors patient’s right to review or
revise their AD
 EP13 Hospital honors AD in accordance with
law and regulation and the hospital's capabilities
 EP15 Must document patient’s wishes regarding
organ donation when she makes her wishes
know or when required by hospital’s P&P
119
RI.01.05.01 End of Life Care
 EP16 Hospital honors organ donation wishes of
patient within hospital’s capabilities and in
accordance with law and regulation
 EP17 Existence or lack of an advance directive does
not in any way affect the patient’s right to access care
and treatment
 EP19 Policy on AD in the outpatient setting must be
communicated upon request or when warranted by
the care or service provided
 EP20 Hospital refers outpatients to assistance to
make an AD upon request,
120
RI.01.05.01 End of Life Care
EP 21-For hospitals that use Joint
Commission accreditation for deemed status
(DS) purposes
The hospital defines how it obtains and
documents permission to perform an
autopsy
 CMS CoP requirement
121
What Does This Standard Mean?
 Document that you ask all patients if they have
an AD
 Secure a copy and place on chart
 Have an AD documentation sheet to collect all
required information
 Include if they want to make any changes to the
document
 Use sticker in front of chart so other
departments are aware such as radiology
122
Stamp or sticker on front of chart
 Name:______________________________
 Medical Record Number:_______________
 Date:_______________________________
 This patient has the following advance directives;
 ___ Living Will
 ___ Durable Power of Attorney
 ___ Organ donor card
 ___ Mental health declaration
 ___ DNR
123
What Does This Standard Mean?
 Educate all staff on AD CoP requirement also)
 Educate staff on en during orientation and if
changes made (CMS d of life issues
 Make sure you give patient this right in writing
about their right to accept or refuse care
including to withhold or withdrawal life
sustaining treatment when allowed by law
 Do medical record audit on this
 Know who can fill out an AD for the patient if
they don’t have one and want one
124
What Does This Standard Mean?
 Need to work with OPO and honor patient
wishes to be an organ donor
 Document one call rule to OPO
 CMS requirement also
 In outpatient setting need to communicate to
patient what your policy is
 Include in patient rights
 May want to honor if presented to staff at each
outpatient encounter (lab, x-ray, outpatient
department, PT, etc.)
125
Know Your Hospital Policy on DNR
126
127
RI.01.06.03 Neglect and Abuse
Standard; the patient has the right to be free
from neglect, exploitation or verbal, mental,
and sexual abuse
 EP1 Hospital determines how it will protect the
patient from neglect, exploitation or abuse while the
patient is receiving care or treatment
 EP2 Must evaluate all allegations, observations, or
suspected case that occur in the hospital
 EP3 Must report these to appropriate authorities
based on the evaluations of the suspected events,
or as required by law
128
What Does This Standard Mean?
 Have a policy and make sure staff is aware of it
 Include definitions from both TJC and CMS
 CMS also has standard and requires ongoing
education on abuse and neglect
 Policy needs to address how it will protect patients
and investigation should be through and
comprehensive
 Refer to board of nursing, etc. if indicated
 This is a very important issues with both the Joint
Commission and CMS!
129
TJC defines as follows:
 Abuse is an intentional maltreatment of a patient
which may cause injury, either physical or
psychological
 Mental abuse includes humiliation, harassment,
and threats of punishment or deprivation
 Physical abuse includes hitting, slapping, pinching,
or kicking. Also includes controlling behavior
through corporal punishment
 Sexual abuse includes sexual harassment, sexual
coercion, and sexual assault
130
Make Sure Policy has TJC, CMS, & State Law
131
132
RI.01.06.05 Pleasant Environment
Standard: patient has the right to an
environment that preserves dignity and
contributes to a positive self-image
 Hospitals that provide longer term care
 EP1 Hospital EOC supports patient’s positive self
image and dignity (eliminated July 1, 2010)
 EP2 The number of patients in a room is based
on patient ages, developmental levels, clinical
conditions, and diagnostic needs for hospitals
that provide long term or more than 30 days
133
RI.01.06.05 Pleasant Environment
 EP4 Patient can keep and use or personal
clothing and possessions unless it infringes on
other rights, or
 Is medically or therapeutically contraindicated
 EP15 Patients are provided telephones and mail
based on the population setting
 EP16 Must provide access to phones for
patients who need a private phone conversation
in a private space, based on population and
setting
134
RI.01.06.05 Pleasant Environment
 The following are for patients who are inpatients for
more than 30 days
 EP17 If visitors, mail, phone calls or other forms
of communication are restricted, the restriction
are determined with the patient’s participation in
LTC
 EP18 These restrictions have to be justified and
documented in the medical record
 EP19 These restrictions have to be evaluated
for therapeutic effectiveness
135
What Does This Standard Mean?
 Patients who enter the hospital have a right to
a environment that is conductive to care
 Unit or room becomes their home especially in
LTC unit
 Sufficient storage to hand clothes and
possession,
 Can keep personal clothing and possessions
unless infringes on right
 Protect confidentiality and privacy of health
information
136
RI.01.07.01 Complaints & Grievances
Standard: Patient and or her family has the
right to have a complaint reviewed
 TJC calls it complaints and CMS calls it grievances
 EP1 Hospital must establish a complaint resolution
process
 See also MS.09.01.01, EP1
 EP2 Patient and family is informed of the complaint
resolution process
 EP4 Complaints must be reviewed and resolved
when possible
137
RI.01.07.01 Complaints & Grievances
 EP6 Hospital acknowledges receipt of a complaint
that cannot be resolved immediately
 Hospital must notify the patient of follow up to the
complaint
 EP7 Must provide the patient with the phone
number and address to file the complaint with the
relevant state authority
 EP10 The patient is allowed to voice complaints
and recommend changes freely with out being
subject to discrimination, coercion, reprisal, or
unreasonable interruption of care
138
RI.01.07.01 Complaints and Grievances
 EP 17 Board reviews and resolves grievances
unless it delegates this in writing to a grievance
committee (eliminated but still CMS requirement)
 EP 18 Hospital provides individual with a written
notice of its decision which includes (DS)
 Name of hospital contact person
 Steps taken on behalf of the individual to investigate the
complaint
 Results of the process
 Date of completion of the grievance process
139
RI.01.07.01 Complaints and Grievances
 EP19 Hospital determines the time frame for
complaint review and response(DS)
 EP20 Process for resolving grievances includes
a timely referral of patient concerns regarding
quality of care or premature discharge to the
QIO (DS)
 EP21 Board approves the C&G process
(eliminated but still CMS standard)
 Note that CMS has detailed section on
grievances starting at tag number A-0118
140
QIO
QIO or Quality Improvement Organizations are CMS
contractors
Charged with reviewing the appropriateness and quality of
care rendered to Medicare beneficiaries in the hospital setting
QIOs to make beneficiaries aware of fact they have a
complaint regarding the quality of care, disagree with coverage
decision or wish to appeal a premature discharge
Patient can ask that complaint be forwarded to the QIO by the
hospital
List of QIOs at
http://www.qualitynet.org/dcs/ContentServer?pagename=Medqic/MQGeneralPage/GeneralPag
eTemplate&name=QIO%20Listings
141
CMS Definition of Grievance A-0118
 Definition: A patient grievance is a formal or
informal written or verbal complaint
 when the verbal complaint about patient care is not
resolved at the time of the complaint by staff
present
 by a patient, or a patient’s representative, regarding
the patient’s care, abuse, or neglect, issues related
to the hospital’s compliance with the CMS CoP
 or a Medicare beneficiary billing complaint related
to rights and limitations provided by 42 CFR 489
142
What Does This Standard Mean?
 CMS has similar section on grievances in hospital
CoP
 Include TJC and CMS requirements in one policy
 Need a formal process
 CMS requires grievance committee
 Do as part of your PI
 Make sure patients rights tells patient who to contact
if concerns or comments about their care
 Include that reports can be made to QIO, TJC, or
state department of health along with phone
numbers,
143
RI.01.07.03 Protective Services
Standard: Patient has a right to protective
and advocacy services
EP1 Resources must be provided to help
families and the court to determine the
patient’s needs for services
 When the hospital serves a population of patient
that need these protective services
 Such as guardianship, child or protective
services, and advocacy services
144
RI.01.07.03 Protective Services
EP2 The hospital must maintain a list of
names, addresses, and phone numbers of
patient advocacy groups
Such as the state authority and the
protection and advocacy network
EP3 The hospital gives the list of patient
advocacy groups to the patient when
requested
145
What Does This Standard Mean?
The list is given to patients when
requested
Hospital should have P&P
P&P should reflect your state law
For example how to get a guardianship
for a patient
146
RI.01.07.07 Long Term Psych Services
Standard: The hospital protects the rights of
patients who work for or on behalf of the
hospital for psychiatric hospital settings that
provide longer term care (more than 30
days)
 EP1 Have a written P&P that addresses
situation in which patients would be allowed to
work for the hospital
 EP2 Hospital must follow or implement this P&P
147
RI.01.07.07 Long Term Psych Services
EP3 Patients must be paid for work on behalf
of the hospital as in accordance with law and
regulation
EP4 Must incorporate the work performed on
behalf of the hospital into the plan of care
EP5 Patients have the right to refuse to
work for or on behalf of the hospital
 New standards
148
RI.02.01.01 Patient Responsibilities
Standard: The patients are informed about
their responsibilities related to care,
treatment, and services
 To support consistent responsibilities of patients
 To support communication with patients
 EP1 must have a written P&P that defines the
responsibilities of the patients
 This must include, but not be limited to, providing
information, asking questions, accepting
consequences, following rules and regulations
149
RI.02.01.01 Patient Responsibilities
 Showing respect and consideration
 Acknowledging that they do or do not understand the
treatment course
 Supporting mutual consideration and respect by
maintaining civil language and conduct
 And meet their financial obligations
 EP2 The patients are informed of their
responsibilities in accordance with the hospital P&P
 Patient responsibilities should be shared with
patients verbally, in writing, or both
150
What Does This Standard Mean?
 The patients rights statement also contains
responsibilities of the patient,
 These need to be in writing and given to the
patient,
 Need P&P and should include how this information
is provided to the patient such as giving separate
Rights and Responsibility document,
 Or listed on back of consent form,
 Sample language for responsibilities following the
end slide,
151
The End
Questions?
 Sue Dill Calloway RN, Esq.
CPHRM
 AD, BA, BSN, MSN, JD
 Additional resources on
 Consent for research
 CMS visitation rights for those who
want more information
 Sample language for patient
responsibilities and billing practices
 Information on who is qualified or
certified to be an interpreter
152
Patient Responsibilities
 Asking questions.
Patients and their families are expected to
ask questions when they do not understand
something. Hospitals staff sometime talk
using medical lingo. Physicians and staff
may try to keep the discussion at a level the
patient can understand, but it is up to the
patient to tell them if they are confused.
153
Patient Responsibilities
Meeting financial needs.
Patients and their families should ask
questions and talk with the business office
about their financial obligations. They are
responsible to make sure the hospital has
the correct billing information and answer
and assist the hospital in getting their bill
paid.
154
Patient Responsibilities
Showing respect and consideration.
 Patients and families need to behave in a
specific manner and decorum. Patients need
to be considerate of the hospital’s staff and
property. They also need to be considerate
of other patients and their property.
Patient who plays loud music at 2am would
be disruptive to his room mate or other
patients,
155
Patient Responsibilities
Accepting consequences.
 Patients and their families are accountable
and responsible for the outcomes if they
follow the recommended treatment
recommended by the physicians and other
staff. Patients who leave without being seen
or leave against medical advice are
responsible for the outcome that results
from not following the recommended
treatment plan. (con’t on next page)
156
Patient Responsibilities
Healthcare professionals often make
recommendations such as smoking
cessation, reduction of weight, or dietary
recommendations that are based on the
medical evidence of providing positive
outcomes and which are in the best interest
of the patients. It is not fair to the healthcare
provider to not follow their advice and expect
the provider to be responsible.
157
Patient Responsibilities
 Following rules and regulations.
 All healthcare facilities have rules and regulations
that must be followed. Rules and regulations are
necessary for a variety of reasons including
infection control and patient safety considerations.
 Restriction of minors visiting certain areas, or use
of cell phones next to critical care equipment to
patients wearing gowns in the operating rooms are
all example of typical rules that patients and their
families must follow for the safety of all,
158
Patient Responsibilities
Following instructions.
All patients must follow instructions that are
provided by their physicians and staff.
Patients need to follow their plan of care and
treatment. Hospitals make every effort to
adapt the plan to the specific needs of the
patient. If adaptation to the care, treatment,
and service plan are not followed, then the
patient is informed of the consequences of
what can happen if they don’t,
159
Patient Responsibilities
 Providing information.
Patients need to provide accurate and
complete information about present
complaints, past illnesses, hospitalizations,
medications, and other matters relating to
their health. Patients should answer all
questions truthfully. Patients can help the
hospital by also providing honest feedback
about their services and expectation.
160
Patient Friendly Billing Project
Project spear headed by HFMA to promote
clear and concise patient friendly financial
communication,
Addresses patient’s rights to understand
and prepare for their financial obligation
Patients want to know what they will be
expected to pay
 www.hfma.org/library/revenue/PatientFriendlyBillin
g/
161
162
TJC HR.01.02.01 Pt Centered Communication
 Standard: The hospital defines staff qualifications
 Qualifications for language interpreters and
translators may be met through language
proficiency assessment, education, training and
experience
 Hospital has flexibility to define the qualifications
for their interpreters and translators
– The use of qualified interpreters and translators is supported
by the ADA, Section 504 of the Rehabilitation Act of 1973,
and Title VI of the Civil Rights Act of 1964
– The federal laws will be discussed later
163
HR.01.02.01 Examples
 Someone who is fluent in Spanish and has attended
a minimum 40 hour education class is qualified to
be an interpreter
 There is no current national certification specifically
for healthcare interpreters
 However, two organizations were formed to meet
the needs for providing certification of professional
competence that meet national standards of
knowledge, skill, and performance for healthcare
interpreters
164
HR.01.02.01 Examples
 There are now two organization that provide
certification of professional competence in Spanish
 First one in September 2009
– Certification Commission for Healthcare Interpreters
CCHI
 Second one effective January of 2011
– It is an oral and written exam from National Board of
Certification
– So now this person is qualified and certified
– Offered only in Spanish but other languages
forthcoming
165
Education Content of Programs CCHI
166
Qualifications to Take Exam CCHI
 Healthcare Interpreters must meet the following
eligibility requirements before they can apply for the
examination.
 Minimum age of 18 years.
 At least one year of experience working as a healthcare
interpreter.
 Have a minimum of U.S. high school diploma (or GED) or its
equivalent from another country.
 Have at least 40 hours of healthcare interpreter training
(academic or non-academic program).
 Have linguistic proficiency in English and the target
language(s).
167
HR.01.02.01 How to Meet the Standard
 HR should be aware of the certification status
 Current confusion around issue of certification
 ATA has program for translators of documents but
current passage rate is only about 20%
 Certification exists for American sign language
(ASL) for the deaf
 New emerging area for interpreters for standards for
new interpreters education
 Many formal programs and colleges adding this to
their curriculum
168
Certification and Meeting the Standard
 HR should make sure medical interpreters have formal
education and be trained and assessed in medical
interpretation and experience
 HR should maintain a file on all interpreters regardless of
their employment status
 Same level of documentation with remote telephone or video
language service providers
 American Sign Language (ASL) interpreters may receive
national certification through a joint program of the
Registry of Interpreters for the Deaf (RID) and the
National Association of the Deaf
 The ASL interpreter certifications is not specific to health care
169
Certification CHI AHI CMI QMI SMI
 National Council on Interpreting in Health Care and
CCHI or the Certification Commission for
Healthcare Interpreters (CCHI Associate Healthcare
Interpreter credential and has two credentials)
 CHI stands for Certified Healthcare Interpreter (best)
 AHI stands for Associate Healthcare Interpreter
 The National Board of Certification for Medical
Interpreters
 CMI or Certified Medical Interpreter, Qualified Medical
Interpreter (QMI) or Screened Medical Interpreter (SMI)
 Question contact [email protected]
170
Two Credentials of CCHI
171
www.healthcareinterpretercertification.org/
172
Certification for Interpreters
 Many people use this term “certified interpreter”
when they only attended an education program
 Participants will receive a certification of attendance
or participation which has been confused with being
certified
 Certification is a formal process by which a governmental,
academic or professional organization attests to an
individual’s ability to provide a particular service.
 Certification calls for formal assessment, using an
instrument that has been tested for validity and reliability, so
that the certifying body can be confident that the individuals it
certifies have the knowledge, skills and abilities needed to do
the job.
173
Certification for Interpreters
 Initial work done in a pilot program by the
Massachusetts Medical Interpreters Association
(MMIA, now the IMIA)
 Funded by the U.S. Office of Minority Health
 Done in collaboration with the California Healthcare
Interpreters Association (CHIA) and the National
Council on Interpreting in Health Care (NCIHC)
 The Certification Commission for Healthcare
Interpreters is continuing their mission to develope
certification for health care interpreters
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Proposed National Training Standards
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Certification for Translators
 However, ATA or the American Translators
Association, has a general certification program to
enable individual translators to demonstrate that
they met professionals standards
 ATA certification is awarded to candidates who
pass an open book exam
 Is a testament to translator’s competence in
translating one specific language to another
 Source: A Guide to Understanding Interpreting and
Translation in Health Care by NCIHC
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Guide to Understanding Interpreting
 A Guide to Understanding Interpreting and
Translation in Health Care is an excellent resource for
HR staff
 Has requisite skills and qualifications of a translator
and an interpreter
 Discusses certification for interpreters and translators
 Discusses how to hire an interpreter or translator
 Discusses standards of practice for an interpreter and
a translator
 What skills are needed for interpreters and translators
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www.ncihc.org/mc/page.do?sitePageId=57022
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http://www.ncihc.org/mc/page.do;jsessionid=EC5D32E43B90F9742
B4E5C91472A5142.mc1?sitePageId=50909
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How to Hire an Interpreter
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Research
 US Dept of Health and Human Services (HHS) and
several other federal agencies, such as Dept of
Education, and the National Science Foundation
 Have regulations on research which are commonly
referred to as the common rule
 To protect human subjects involved in research
 Institutional Review Boards (IRB) reviews research
proposals even if informed consent is obtained, IRB
can waive consent requirement
 See Title 46 Protection of Human Subjects at
www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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Research Consent
 Research investigator needs informed consent from
research subject
 Must be in plain language
 Must include a statement that the study involves
research
 Explanation of the purpose of the research
 Expected duration of the subject’s participation
 Description of procedures to be followed
 Identification of any procedure considered to be
experimental
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Research Elements of Consent
Description of any reasonable foreseeable
risks or discomforts to the subject
Disclosure of any benefits to the subject and
others which may be expected
Disclosure of appropriate alternative
procedures or courses of treatment
Statement to which confidentiality of records
identifying the subject will be maintained
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Research Elements of Consent Cont.
 Contact information for answers to questions
about the research
 Also to include information on patient’s rights in
case of a research related injury
 Statement that participation is voluntary and
refusal to participate involves no penalty or loss
of benefits
 Subject can discontinue participation at any time
without penalty or loss of benefits
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www.hhs.gov/ohrp/informconsfaq.html
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AHRQ Toolkit to Facilitate Consent
 AHRQ toolkit to facilitate the process of
obtaining informed consent
 Also information on the HIPAA authorization
for potential research subjects
 Available at
http://www.ahrq.gov/fund/informedconsent/
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Visitation Law in a Nutshell
 Require all hospitals that accept
Medicare or Medicaid
reimbursement
 To allow adult patients to
designate visitors
 Not legally related by marriage or
blood to the patient
 To be given the same visitation
privileges as an immediate family
member of the patient
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Visitation Rights for All Patients
 CMS issued proposed changes to the CAH and
PPS hospital conditions of participation (CoPs)
 Published in the June 28, 2010 Federal Register (FR) with
comments until August 27, 2010
 Had 7,600 comments but 6,300 were form letters
 CMS publishes the final rule in the November 18,
2010 FR
 Regulation effective January 18, 2011
 Applies to all hospitals that accept Medicare and Medicaid
reimbursement
 This includes all critical access hospitals
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Patient Visitation Right
 This rule revises the hospital CoPs to ensure
visitation rights of all patients including same sex
domestic partners
 Hospitals are required to have policies and
procedures (P&P) on this
 P&P must set forth any clinically necessary or
reasonable restrictions or limitations
 Hospitals will have to train all staff
 Hospitals will be required to give a written copy of this
right to all patients in advance of providing treatment
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Final Rule FR Effective January 18, 2011
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Visitation Rights for All Patients
 The new final rule implements the April 15, 2010
Presidential memo1
 The President gave HHS (Health and Human
Services) the task of requiring any hospital that
receives Medicare reimbursement to preserve the
rights of all patients to choose who can visit them
 Patients or their representative have a right to
visitation privileges that are no restrictive than those
for immediate family members
 1 http://www.whitehouse.gov/the-press-office/presidential-memorandum-hospital-visitation
 2 http://www.access.gpo.gov/su_docs/fedreg/a100628c.html (June 28, 2010 Federal Register)
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Final Language on Patient Visitation Rights
 Standard: Patient visitation rights
 A hospital must have written P&P regarding the
visitation rights of patients
 This includes setting forth any clinically necessary
 Or reasonable restriction or limitation that the
hospital may need to place on such rights
 And the reasons for the clinical restriction or
limitation
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Final Language on Patient Visitation Rights
 A hospital must meet the following 4 requirements:
1. Inform each patient (or support person, where
appropriate) of his or her visitation rights
 Including any clinical restriction or limitation on
such rights
 When he or she is informed of his or her other
rights under this section (previously mentioned)
 For CAH hospitals the last bullet is absent and it
says to do this in advance of furnishing patient care
 Note CAH do not have a pre-exisitng patient rights section
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Final Language on Patient Visitation Rights
2. Inform each patient (or support person, where
appropriate) of the right
 Subject to his or her consent
 To receive the visitors whom he or she
designates
 Including, but not limited to, a spouse, a domestic
partner (including a same sex domestic partner),
 Another family member, or a friend, and his or her
right to withdraw or deny such consent at any
time
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Final Language on Patient Visitation Rights
3. Not restrict, limit, or otherwise deny
visitation privileges on the basis of race,
color, national origin, religion, sex, gender
identity, sexual orientation, or disability
4. Ensure that all visitors enjoy full and equal
visitation privileges consistent with patient
preferences
So what does this mean??
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Patient Visitation Rights
 All hospitals would have to inform all patients of
their visitation rights in writing in advance of care
furnished
 This includes the right to decide who may and may
not visit them
 Some hospitals may give a one page sheet to each
patient upon admission
 Hospitals would want to amend their patient rights
statement to include this information
– Example: written patient rights given to patients on admission and
could have also brochure in admission packet
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Patient Visitation Rights
 Competent patients can verbally give this
information on admission
 There is no requirement that this has to be in writing
if a competent patient gives oral confirmation as to
who he or she would like to visit
 Some patients may sign a written patient visitation
advance directive
 Some patients may add a section to their advance
directive adding a section on who they would like to
visit or deny visitation
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Patient Visitation Rights
 CMS does suggest that this be documented in the
medical record for future reference
 Reading of the Federal Register helps to provide an
understanding of what it means and how to
implement it
 Federal Register (FR) summarizes the comments
and publishes a response
 CMS will eventually add this to the hospital CMS
interpretive guidelines
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Research References
 US Department of Health and Human Services.
“Protection of Human Subjects.” Code of Federal
Regulations, 2002. 45 CFR, Part 46
 Office for Civil Rights. “Medical Privacy—National
Standards to Protect the Privacy of Personal
Health Information.” Section “Research”1
 US Department of Health and Human Services.
“Food and Drugs.” Code of Federal Regulations,
2002. 21 CFR, Part 56, Section 102
1
www.hhs.gov/ocr/hipaa/privacy.html
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CMS
 Thought it would only take hospitals 15 minutes to
update their P&P
 Estimated the cost to provide the patient with a one
page printed disclosure form detailing visitation
rights on admission would be 2 cents a page
 Would anticipate this form would be put in
admission packet so would reduce cost
 Make sure P&P includes any clinically necessary or
reasonable restrictions or limitations and reasons
for these
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Resources
 Rosenberg CE. The Care of Strangers: The Rise of
America's Hospital System. Baltimore, Md: Johns
Hopkins University Press; 1987
 A challenge accepted: open visiting in the ICU at
Geisinger, www.ihi.org
 Marfell JA, Garcia JS. Contracted visiting hours in
the coronary care unit: a patient-centered quality
improvement project. Nurs Clin North Am.
1995;30:87-96 at
http://www.ncbi.nlm.nih.gov/pubmed/7885927?dopt=Abstract
209
Resources
 Gurley MJ. Determining ICU visitation hours.
Medsurg Nurs. 1995;4:40-43 at
http://www.ncbi.nlm.nih.gov/pubmed/7874220?dopt=Abstract
 Krapohl GL. Visiting hours in the adult intensive
care unit: using research to develop a system that
works. Dimens Crit Care Nurs. 1995;14:245-258 at
http://www.ncbi.nlm.nih.gov/pubmed/7656767?dopt=Abstract
 Simon SK, Phillips K, Badalamenti S, Ohlert J,
Krumberger J. Current practices regarding visitation
policies in critical care units. Am J Crit Care.
1997;6:210-217
http://ajcc.aacnjournals.org/cgi/content/abstract/6/3/210?ijkey=e4ebfadff6f205451545c622736f88ef98f36
485&keytype2=tf_ipsecsha
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http://ccn.aacnjournals.org/cgi/content/full/25/1/72
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Breaking Down Barriers
 Document states that lesbian, bisexual, gay, and
transgender (same sex) families face discrimination
when attempting to access healthcare system
 Includes visitation access and medical decision
making during emergencies and end of life care
 Human Rights Campaign Foundation administers
the Healthcare Equity Index of healthcare policies
and procedures and identifies best practices and
policies with equal treatment
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Recommendations
 First establish a definition of permitted visitors
 Then enumerate restrictions on visitor access such
as restriction to sensitive areas such as behavioral
health unit or OB (infant security issues)
 Health concern restrictions such as preventing ill
visitors
 Definition of family is critical and must be broad and
encompass concept of family
 Provides a sample definition of family and
recommendation for what should be in the P&P
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Definition of Family
 Family means any person who plays a significant role in an
individual’s life.
 This may include a person not legally related to the
individual.
 Members of family include spouses, domestic partners, and
both different-sex and same-sex significant others.
 Family includes a minor patient’s parents, regardless of the gender of
either parent. Solely for purposes of visitation policy, the concept of
parenthood is to be liberally construed without limitation as
encompassing legal parents, foster parents, same-sex parent, stepparents, those serving in loco parentis, and other persons operating in
caretaker roles.
 36 Kaiser Permanente hospitals implemented them in June
2010
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Sample Visitation Authorization
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American Hospital Associations
http://www.putitinwriting.org/putitinwriting_app/index.jsp
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Visitation Expanded in the ED
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The Joint Commission
One Size Does Not Fit All: Meeting the Health Care Needs of Diverse Populations
Self-Assessment Tool – Accommodating the Needs of Specific Populations
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So What’s in Your Policy?
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So What’s in Your Policy?
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