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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

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Sue Dill Calloway RN, Esq.




Patient Safety and Healthcare


5447 Fawnbrook Lane

Dublin, Ohio 43017

614 791-1468

[email protected]

patient rights
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
ri chapter
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
cms cop hospital patient rights
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
the revised final cops
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!!!
the conditions of participation
The Conditions of Participation
  • First published in the Federal Register-42 CFR Part 482.
  • Federal Register available at
  • 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
    • Also some changes at Transmittals at
cms survey certification website
CMS Survey & Certification Website

cms patient rights standards 0116 214
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
tjc patient rights
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
tjc patient rights overview
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
tjc patient rights overview1
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
tjc rights include
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
tjc revised requirements
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,


tjc changes to comply with cms cops
TJC Changes to Comply with CMS CoPs
  • RI. 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
tjc know your rights brochure
TJC Know Your Rights Brochure
  • TJC has a flier on the speak up program encouraging patients to know their rights at
    • 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.
tjc know your rights brochure1
TJC Know Your Rights Brochure

faq on patient rights
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
3 faqs on rights and responsibilities
3 FAQs on Rights and Responsibilities

These will be covered under the standards

filming and recording faq
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?
filming and recording faq1
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.
consent when videotaping or filming
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.
patients right is one of 14 pfas
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
patients have the right to
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
patients have the right
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
individual tracers patient rights
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 communicationbetween shifts and departments,
individual tracers patient rights1
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
individual tracers patient rights2
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
aha patient rights
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
aha patient rights brochure
AHA Patient Rights Brochure

aha patient rights expectations
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
aha patient rights expectations1
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
ri 01 01 01 respecting patient rights
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
ri 01 01 01 respecting patient rights1
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
ri 01 01 01 respecting patient rights2
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
ri 01 01 01 respecting patient rights3
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
ri 01 01 01 respecting patient rights4
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
2011 changes mr must contain
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
2011 changes mr must contain1
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
ri 01 01 01 respecting patient rights5
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
what does this standard mean
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
ri 01 01 03 respecting patient rights
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
ri 01 01 03 respecting patient rights1
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
ri 01 01 03 respecting patient rights2
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
interpreters are required by law
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
ri 01 01 03 right to receive information
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
what does this standard mean1
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
what are surveyors looking for
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
what are surveyors looking for1
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
what are surveyors looking for2
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
what are surveyors looking for3
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
advancing effective communication roadmap
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 patient- and family-centered care fields into their facility
  • The Roadmap will help hospitals to comply with the patient-centered communication standards
  • Has educational tools
communication roadmap
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
study finds few hospitals in compliance
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
topics covered in the white paper
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
topics covered in the white paper1
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
tjc r3 report
TJC R3 Report

oig examines provisions of language services
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
tjc video improving patient provider communication
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
  • It is a 31 minute video on how to improve patient-provider communication
  • It is available at no charge
  • Initially standard referred to as patient-provider communication
  • More recently referred to as patient-centered communication
ri 01 02 01 right to participate in decisions
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
ri 01 02 01 right to participate in decisions1
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
ri 01 02 01 right to participate in decisions2
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
ri 01 02 01 unanticipated outcomes
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
what does this standard mean2
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
what does this standard mean3
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
national patient safety foundation
National Patient Safety Foundation
  • “Talking to patients about Health Care Injury.”
    • Available at,
  • 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.
ashrm 4 documents
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
ri 01 03 01 informed consent
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
ri 01 03 01 informed consent1
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
ri 01 03 01 informed consent2
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
ri 01 03 01 informed consent3
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
ri 01 03 01 informed consent4
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
what does this standard mean4
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
what does this standard mean5
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.)
consider list of procedures
Procedure NameRequires 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

Consider List of Procedures
informed consent manual
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


informed consent forms
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
  • 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



ri 01 03 03 recordings and consent
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
ri 01 03 03 recordings and consent1
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
ri 01 03 03 recordings and consent2
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
ri 01 03 03 recordings and consent3
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
ri 01 03 03 recordings and consent4
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
ri 01 03 05 research
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
ri 01 03 05 research1
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,
ri 01 03 05 research2
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
ri 01 03 05 research3
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
ri 01 04 01 persons responsible for care
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
what does this standard mean6
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
ri 01 05 01 end of life care
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
ri 01 05 01 end of life care1
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
ri 01 05 01 end of life care2
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
ri 01 05 01 end of life care3
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,
ri 01 05 01 end of life care4
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
what does this standard mean7
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
stamp or sticker on front of chart
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
what does this standard mean8
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
what does this standard mean9
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.)
ri 01 06 03 neglect and abuse
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
what does this standard mean10
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!
tjc defines as follows
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
ri 01 06 05 pleasant environment
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
ri 01 06 05 pleasant environment1
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
ri 01 06 05 pleasant environment2
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
what does this standard mean11
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
ri 01 07 01 complaints grievances
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
ri 01 07 01 complaints grievances1
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
ri 01 07 01 complaints and grievances
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
ri 01 07 01 complaints and grievances1
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
  • 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
cms definition of grievance a 0118
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
what does this standard mean12
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,
ri 01 07 03 protective services
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
ri 01 07 03 protective services1
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
what does this standard mean13
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
ri 01 07 07 long term psych services
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
ri 01 07 07 long term psych services1
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
ri 02 01 01 patient responsibilities
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
ri 02 01 01 patient responsibilities1
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
what does this standard mean14
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,
the end questions
The End Questions?

Sue Dill Calloway RN, Esq. CPHRM


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



patient responsibilities
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.
patient responsibilities1
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.
patient responsibilities2
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,
patient responsibilities3
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)
patient responsibilities4
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.
patient responsibilities5
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,
patient responsibilities6
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,
patient responsibilities7
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.
patient friendly billing project
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
tjc hr 01 02 01 pt centered communication
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
hr 01 02 01 examples
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
hr 01 02 01 examples1
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
qualifications to take exam cchi
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).
hr 01 02 01 how to meet the standard
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
certification and meeting the standard
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
certification chi ahi cmi qmi smi
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]
certification for interpreters
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.
certification for interpreters1
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
certification for translators
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
guide to understanding interpreting
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
  • 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
research consent
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
research elements of consent
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
research elements of consent cont
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
ahrq toolkit to facilitate consent
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
visitation law in a nutshell
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
visitation rights for all patients
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
patient visitation right
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
visitation rights for all patients1
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
  • 2 (June 28, 2010 Federal Register)
final language on patient visitation rights
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
final language on patient visitation rights1
Final Language on Patient Visitation Rights
  • A hospital must meet the following 4 requirements:
  • 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
final language on patient visitation rights2
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
final language on patient visitation rights3
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??
patient visitation rights
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
patient visitation rights1
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
patient visitation rights2
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
research references
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


  • 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
  • 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,
  • 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
  • Gurley MJ. Determining ICU visitation hours. Medsurg Nurs. 1995;4:40-43 at
  • 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
  • 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
breaking down barriers
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
  • 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
definition of family
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, step-parents, those serving in loco parentis, and other persons operating in caretaker roles.
  • 36 Kaiser Permanente hospitals implemented them in June 2010
american hospital associations
American Hospital Associations

the joint commission
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