CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2011 What PPS Hospitals Need to Know - PowerPoint PPT Presentation


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2011 What PPS Hospitals Need to Know
  • Sue Dill Calloway RN, Esq.
  • AD, BA, BSN, MSN, JD
  • President
  • Patient Safety and Healthcare
  • Education
  • 5447 Fawnbrook Lane
  • Dublin, Ohio 43017
  • 614791-1468

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The Conditions of Participation
  • Regulations first published in 1966
  • Many revisions since with final interpretive
    guidelines June 5, 2009 (Tag 450 Medical Record)
    and anesthesia (December 11, 2009, February 5,
    2010, May 21, 2010 and February 14, 2011) and
    Respiratory and Rehab Orders August 16, 2010 and
    Visitation 2011
  • First regulations are published in the Federal
    Register first-42 CFR Part 4821
  • CMS then publishes Interpretive Guidelines2
  • Hospitals should check this website once a month
    for changes

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Respiratory and Rehab Orders
  • Published in the August 16, 2010 Federal Register
  • Allows a qualified licensed practitioner who is
    responsible for the care of the patient (such as
    a PA or NP)
  • Who is acting within their scope of practice
    under state law
  • Can order respiratory or rehab order (physical
    therapy, occupational therapy, speech)
  • Must be privileged (authorized) by the MS
  • Must have hospital PP to allow also

  • Effective January 19, 2011
  • Must rewrite policy on visitation including
    visiting hours in ICU
  • Must inform each patient of their visitation
  • Must include any restrictions on those rights
  • Can not restrict or deny visitation privileges on
    the basis of race, color, national origin,
    religion, sex, sexual orientation, gender
    identity or disability
  • For example same sex partner may present
    visitation advance directive

Federal Register Visitation Changes
CMS Proposed New Rule
  • CMS proposed new rule for notifying beneficiaries
    of their right to file a quality of care
  • Give beneficiaries written notice of their right
    to contact their state QIO or Quality Improvement
  • Also include
  • Currently, only hospital inpatients receive this
  • Includes 10 facilities such as clinics, CAH, LTC,
    hospices, home health agencies, ASCs,
    comprehensive outpatient rehab facilities,
    portable X-ray services and rural health clinics

Medicare Patients, Complaints and the QIO
  • The proposed rule was published in the Federal
    Register on February 2, 2011
  • at http//
  • QIOs must conduct a review of all written
    complaints about the quality of care for Medicare
    patients only
  • Current hospital CoP includes a requirement that
    the grievance process must include a mechanism
    for timely referral to the QIO of beneficiary
    concerns regarding quality of care
  • Must also give Medicare patients a copy of their
    IM Notice

Medicare Patients, Complaints and the QIO
  • Since 9th scope of work started August 1, 2008,
    QIOs have received 6,379 inpatient and 4,1116
    outpatient requests
  • Feel number is inadequate because Medicare
    patients do not know they can complain to their
  • Expanding now that Medicare patients, or their
    representative, will receive written notice at
    the start of their care, of their right that they
    can complain about quality of care issues to the
    QIO in other settings
  • Such as time of admission or in advance of
    furnishing care

Medicare Patients, Complaints and the QIO
  • Medicare patient who is competent can also decide
    to have the written notice given to their
    surrogate such as a friend or family member
  • Remember if need to use an interpreter for
    limited English proficiency (LEP) or deaf/hard of
    hearing patients
  • Unless patient signs a waiver declining
  • Remember the 2011 TJC patient centered
    communication standards
  • Also 7 of the 10 providers must include
    information to contact the state agency
  • Hospitals, HH, RHC, CORF, FQHCs, Hospices, clinics

Specific Requirements
  • For example an ASC, hospice, hospitals, home
    health, hospice etc. would have to do the
  • Give the patient a written notice of their right
    to notify the QIO
  • Must include at the time of admission or in
    advance of furnishing care
  • Must include name, telephone number, email
    address, and mailing address
  • Must document in the medical record that the
    notice was given

Proposed FR February 2, 2011
TJC Revised Requirements
  • TJC has published many changes over the past two
  • Many of the changes reflected in their standards
    is to be in compliance with the CMS CoP
  • Standards are for hospitals that use them to get
    deemed status to allow payment for M/M patients
  • This means hospitals do not have to have a survey
    by CMS every 3 years
  • Can still get a complaint or validation survey
  • So now TJC standards crosswalk closer to the CMS
    CoPs (not called JCAHO any more)

4th Anesthesia Changes February 14, 2011
Respiratory and Rehab Changes
Mandatory Compliance
  • Hospitals that participate in Medicare or
    Medicaid must meet the COPs for all patients in
    the facilities and not just those patients who
    are Medicare or Medicaid
  • Hospitals accredited by TJC, AOA, or DNV
    Healthcare have what is called deemed status
  • These are the only 3 that CMS has given deemed
    status to for hospitals
  • This means you can get reimbursed without going
    through a state agency survey
  • States can still institute a survey and be more

CMS Hospital CoPs
  • All Interpretative guidelines are in the state
    operations manual and are found at this website1
  • Appendix A, Tag A-0001 to A-1163 and 370 pages
  • You can look up any tag number under this manual
  • Manuals
  • Manuals are now being updated more frequently
  • Still need to check survey and certification
    website once a month and transmittals to keep up
    on new changes 2
  • 1http//
  • 2 http//

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Conditions of Participation (CoPs)
  • Important interpretive guidelines for hospitals
    and to keep handy
  • A- Hospitals and C-Critical Access Hospitals
  • C-Labs
  • V-EMTALA (Rewritten May 29, 2009 and amended July
  • Q-Determining Immediate Jeopardy
  • I-Life Safety Code Violations
  • All CMS forms are on their website

Contact for Questions
  • Resource is your state department of health or
    regional CMS office
  • The American Hospital Association or state
    hospital association may be of assistance
  • Note that when changes are published in the
    Federal Register there is always the name and
    phone number of a contact person at CMS

Survey Procedure
  • Step one is publication in Federal Register
  • Step two is where CMS publishes the interpretive
  • The interpretive guidelines provide instructions
    to the surveyors on how to survey the CoPs
  • These are called survey procedure
  • Not all the standards have survey procedures
  • Questions such as Ask patients to tell you if
    the hospital told them about their rights

Interpretive Guidelines
  • Surveyors use the information contained in the
    interpretive guidelines
  • They do not replace or supersede the law
  • Should not be used as basis for citation
  • They do contain authoritative interpretations and
    clarifications which can assist surveyors in
    making determinations of compliance

Compliance Recommendation
  • Assign each section of the hospital CoPs to the
    manager of that department
  • Do a side by side gap analysis like the TJC PPR
    for each section
  • Have standard on left side and go line by line
    and document compliance on the right side
  • Keep a hard copy of CoP and analysis
  • Designate someone in charge if a validation,
    complaint, or unannounced survey occurs
  • Commonly referred to as the CoP king or queen

CMS Required Education
  • These will be discussed throughout presentation
  • Restraint and seclusion (annual)
  • Abuse, neglect and harassment (annual)
  • Infection control
  • Advance directive
  • Organ donation
  • IVs and blood and blood products
  • ED common emergencies, IVs and blood and blood
    products for ED

Whats Really Important
  • Life Safety Code Compliance
  • Infection Control and CMS gets 50 million grant
    to enforce in 2011
  • Patient Rights especially RS and grievances
  • Performance Improvement (CMS calls it QAPI)
  • Medication Management
  • Dietary and cleanliness of dietary

Whats Really Important
  • Verbal orders
  • History and physicals
  • Need order for respiratory and rehab (such as
    physical therapy)
  • Need order for diet, medications, and radiology
  • Anesthesia (updated four times)
  • Standing orders and protocols
  • Medications within 30 minute time frame
  • Outpatient under one person (Tag 1078)

Survey Protocol
  • First 37 pages list the survey protocol,
    including sections on
  • Off-survey preparation
  • Entrance activities
  • Information gathering/investigation
  • Exit conference
  • Post survey activities

Survey Protocol
  • Survey done through observation, interviews, and
    document review
  • Usually surveys are done Monday - Friday but can
    come on weekends or evenings
  • Federal law allows CMS or department of health
    surveyors access to your facility
  • CAH rehab or psych (behavioral health) is
    surveyed under this section even though CAH has
    separate manual

Survey Team
  • Mid-sized hospital with a full survey
  • Two to four surveyors for three or more days and
    at least one RN with hospital survey experience
  • Team based on complexity of services offered
  • SA (state agency) decides or RO (regional office)
    for federal teams
  • Have an organized plan for an unannounced survey
    with designated persons to accompany surveyors
  • Include education of security or those who attend
    to the front desk where surveyors could enter in
    the morning

Task 1 Off Site Survey Prep
  • Team coordinator gathers information about
    provider (ownership, types of services offered,
  • Determines if provider based, remote locations,
    PPS-exempt services offered
  • Information collected from CMS database such as
    previous surveys and findings, size of facility,
    and average daily census
  • Team should enter together and usually goes to

Task 2 Entrance Activities
  • Team will explains purpose and scope of survey
  • ENTRANCE CONFERENCE sets the tone for entire
  • Give surveyors conference room, telephone
  • Give names of department heads, their location
    and phone numbers
  • CMS has a list of documents they may ask for so
    be ready and know what is on this list
  • Provide organizational chart

Task 2 Entrance Activities
  • Provide additional information
  • Infection control plan
  • Names and addresses of all off-site locations and
    provider numbers
  • List of employees
  • Medical staff bylaws, rules and regulations
  • List of contracted services
  • Copy of floor plan
  • List of current patients with room numbers,
  • Give preliminary date and time for exit

Task 3 Information Gathering
  • Purpose is to determine compliance with CoPs thru
    observation, interviews, and document review
  • Will visit patient care areas including ED and
    outpatient, Imaging, rehab, and remote locations
  • Observe actual care (IV, tube feeding, wound
    dressing changes)
  • May observe a nurse pass medications
  • Review copies of materials
  • Use interpretive guidelines to guide survey

Task 3 Information Gathering
  • Use Appendix Q if Immediate Jeopardy is suspected
  • Surveyor has discretion whether to allow staff to
    accompany the surveyor
  • All significant adverse events should be brought
    to the team coordinators attention immediately
  • Surveyors must respect patient privacy and
  • Work with surveyor so they do not take
    peer-review protected documents with them

Task 4 Analysis of Finding
  • If surveyor makes copies of documents ask to make
    one for the hospital
  • No federal review law but if in PSO surveyor can
    not see
  • Review and analyze all information gathered
  • Determine if CoPs are met and if PPS exclusionary
    criteria (42 CFR Part 412, subpart B) or swing
    bed (42 CFR 482.66)
  • Prepare exit conference report
  • If noncompliance with CoP then determine if at
    standard or condition level and how dangerous it

  • Condition level - (NOT GOOD) due to noncompliance
    with requirement in a single standard or several
    standards within the condition or single tag but
    represents a severe or critical health breach,
    (need to have conversation)
  • Standard level - noncompliance as above but not
    of such a character to limit facilitys capacity
    to furnish adequate care - no jeopardy or adverse
    effect to health or safety of patient
  • Try and work with the surveyor to resolve the
    issue before CMS leaves the building

Task 5 Exit Conference
  • Objective - inform facility of preliminary
  • Policy is to do exit conference
  • Can refuse if hostile environment or
  • Counsel tries to turn into evidentiary hearing
  • If recorded, must provide two tapes and tape
  • Tape at same time and give surveyor one
  • Official findings are provided in writing on Form
    CMS 2567 (all forms on CMS website now)

Task 5 Exit Conference
  • Surveyor can set ground rules
  • Present findings of noncompliance
  • Statement of deficiencies will be mailed and have
    10 working days to fix (Form 2567)
  • This form is made public no later than 90 days
    after survey
  • So try and fix before the surveyor leaves
  • List deficiencies, plans for correction,
    timelines and opportunity to refute findings

Task 6 Post-Survey Activities
  • Objective is to complete the survey and
    certification requirements and notify staff
    regarding survey results
  • Complete hospital restraint/seclusion death
    reporting worksheet as appropriate
  • Enter information into hospital Medicare database
  • Certification of providers with deficiencies if
    acceptable plan of correction

Interpretive Guidelines
  • Starts with a tag number, example A-0001
  • A refers to the hospital CoPs
  • Goes from 0001 to 1163
  • The three sections from Federal Register (CFR)
    include the regulation, interpretive guidelines
    and survey procedure
  • Survey procedure
  • Not in every section
  • Explains survey process, policies that will be
    reviewed, questions that will be asked and
    documents reviewed

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Compliance with Laws A-0020
  • The hospital must be in compliance with all
    federal, state, and local laws
  • Survey procedure tells surveyor to interview CEO
    or other designated by hospital
  • Refer non-compliance to proper agency with
    jurisdiction such as OSHA (TB, blood borne
    pathogen, universal precautions, EPA (haz mat or
    waste issues), or Rehabilitation Act of 1973
  • Will ask if cited for any violation since last

Compliance with Laws 0023, 0022
  • Hospital must be licensed or approved for meeting
    standards for licensure, as applicable
  • Personnel must be licensed or certified if
    required by state (doctors, nurses, PT, PA,
  • If telemedicine used must be licensed in state
    patient located and where practitioner is located
  • See proposed changes on telemedicine
  • Verify that staff and personnel meet all
    standards (such as CEs) required by state law
  • Review sample of personnel files to be sure
    credentials and licensure is up to date

Governing Body (Board) A-0043
  • Hospital must have an effective governing body
    responsible for the conduct of the hospital as an
  • Written documentation identifies an individual as
    being responsible for conduct of hospital
  • Board makes sure MS requirements are met
  • Board must determine which categories of
    practitioners are eligible for appointment to
    medical staff (MS), as allowed by your state law
    (CRNA, NP, PAs, nurse midwives, chiropractors,
    podiatrists, dentists, etc.)

Medical Staff and Board
  • Board appoints individuals to the MS with the
    advice and recommendation of the MS (0046)
  • Will review board minutes to make sure they are
    involved in appointment of MS
  • Board must assure MS has bylaws and they comply
    with the CoPs (0047)
  • Board must make sure they have approved the MS
    bylaws and rules and regulations (0048) and any
  • TJC MS.01.01.01 as to what goes into a bylaw or

Medical Staff and Board
  • Board must ensure MS is accountable to the board
    for the quality of care provided to patients
  • All care given to patients must be by or in
    accordance with the order of practitioner who is
    operating within privileges granted by the Board
  • Need order for any medications
  • Need to document the order even if there is a
    protocol approved by the medical board for it
  • ED nurse starts IV on patient with chest pain and
    documents it in the order sheet
  • Discussed later under section 407 and 450

Board and Medical Staff
  • Board ensures that criteria for selection of MS
    members is based on (0050)
  • MS privileges describe privileging process and
    ensure there is written criteria for appt to MS
  • Individual character, competence, training,
    experience and judgment
  • Make sure under no circumstances is staff
    membership or privileges based solely on
    certification, fellowship, or membership in a
    specialty society (0051)
  • TJC has a tracer now on this

TJC Tracer MS Credentialing and Privileging
  • Will look at the design of the MS and look at
    verification of credentials, limitations or
    relinquishing privileges, health status,
    morbidity and mortality, peer recommendations etc
  • Consistent process for all practitioners
  • Scope of the MS process to determine if all LIPs
    and other practitioners are reviewed
  • The link between results of ongoing professional
    practice evaluation and focused professional
    performance evaluation and the adherence to

TJC Tracer MS Credentialing and Privileging
  • How the organization is monitoring the
    performance of all licensed independent
    practitioners on an ongoing basis
  • How does the hospital evaluates performance of
    LIPs who do not have current performance
    documentation (FPPE)?
  • How does the hospital evaluate LIPs who
    performance has raised concerns regarding safe
    quality care?
  • Will look to see if state opted out supervision
    with CRNAs, PPs for supervision of CRNAs, etc

Board and the Medical Staff
  • CMS Guidance issued to clarify it is a
    recommendation that MS must conduct appraisals of
    practitioners at least every 24 months
  • Need to do every 24 months if TJC accredited
  • MS must examine each practitioners
    qualifications and competencies to perform each
    task, activity, or privilege
  • Included current work, specialized training,
    patient outcomes, education, currency of
    compliance with licensure requirements
  • MS section repeated in tag 338-363 so will not

CEO A-0057
  • Board must appoint a CEO who is responsible for
    managing the hospital
  • Verify CEO is responsible for managing entire
  • Verify the board has appointed a CEO
  • CEO is a very important position and CMS has only
    a small section
  • TJC in the leadership standard has more detailed
    information on the role of the CEO

Care of Patients 0063-0068
  • Board must make sure every patient has to be
    under the care of a doctor (or dentist,
    podiatrist, chiropractor, psychologist, et. al.)
  • Practitioners must be licensed and a member of MS
  • If LIPs can admit (NP, Midwives) still need to
    see evidence of being under care of MD/DO
  • If state law allows needs policies and bylaws to
    ensure compliance
  • Exception is a separate federal law where no
    supervision required by midwives for Medicaid

Care of Patients 0063-0068
  • Evidence of being under care of MD/DO must be in
    the medical record
  • Verify with your state department of health what
    documentation is required
  • Board and MS establish PP and bylaws to ensure
  • Board must make sure doctor is on duty or on call
    at all times, doctor of medicine or osteopathy is
    responsible for monitoring care M/M patient
  • Interview nurses and make sure they are able to
    call the on-call MD/DO and they come to the
    hospital when needed

Care of Patients 0067-68
  • Patient admitted by dentist, chiropractor,
    podiatrist etc., needs to be monitored by a
    MD/DO, as allowed by state law
  • Each state has a scope of practice which talks
    about what they can do
  • The board and MS must have policies to make sure
    Medicare/Medicaid patient is responsible for any
    care OUTSIDE the scope of practice of the
    admitting practitioner
  • What is the scope of practice in your state for
    NP, CRNAs, Midwifes, and PAs?

Plan and Budget 0073-0077
  • Need institutional plan
  • Include annual operating budget with all
    anticipated income and expenses
  • Provide for capital expenditures for 3 year
  • Identify sources of financing for acquisition of
    land improvement of land, buildings and equipment
  • Must be submitted for review
  • TJC has similar standards in its leadership

Plan and Budget
  • Need institutional plan
  • Must include acquisition of land and improvement
    to land and building
  • Must be reviewed and updated annually
  • Must be prepared under direction of board and a
    committee of representatives from the Board
    administrative staff, and MS (077)
  • Verify that all 3 participated in the plan and

Contracted Services
  • Board responsible for services provided in
    hospital (0083)
  • Whether provided by hospital employees or under
  • Board must take action under hospitals QAPI
    program to assess services provided both by
    employees and under direct contract
  • Identify quality problems and ensure monitoring
    and correction of any problems
  • TJC has more detailed contract management
    standards in LD chapter, revised 7-1-10

Contracted Services
  • Board must ensure services performed under
    contract are performed in a safe and efficient
  • Increased scrutiny on contracted services
  • Review QAPI plan to ensure that every contracted
    service is evaluated
  • Maintain a list of all contracted services (85)
  • Contractor services must be in compliance with
  • Consider adding section to all contracts to
    address CoP requirements

Emergency Services 0091
  • Remember to see the EMTALA separate CoP
  • Revised May 29, 2009 and amended July 2010 and
    now 64 pages
  • Consider doing yearly education on EMTALA to your
    ED staff and for on call physicians
  • If hospital has an ED, you must comply with
    section 482.55 requirements
  • If no ED services, Board must be sure hospital
    has written PP for emergencies of patients,
    staff and visitors

Emergency Services 0091
  • Qualified RN must be able to assess patients
  • Verify that MS has PP on how to address
    emergency procedures
  • Need PP when patients needs exceed hospitals
  • Need PP on appropriate transport
  • Train staff on what to do in case of an emergency
  • Should not rely on 911 for on-campus and need
    trained staff to respond to the code or emergency

Emergency Services 0091
  • If emergency services are provided at the
    hospital but not at the off campus department
    then you need PP on what to do at the off-campus
    department when they have an emergency
  • Do whatever you can to initially treat and
    stabilize the patient etc
  • Call 911 (off campus only!)
  • Provide care consistent with your ability
  • Includes visitors, staff and patients
  • Make sure staff are oriented to the policy

Patient Rights
  • Changes many standards related to grievances and
    restraint and seclusion (RS)
  • Sets forth standards regarding RS staff training
    and education
  • Sets forth standards on RS death reporting
  • TJC also has chapter on 14 patient rights or RI
    Rights and Responsibilities of the Individual
    starting with RI.01.01.01 thru 02.02.01

Patient Rights Standards 0115-0214
  • Minimum protections and rights for patients
  • Right to notification of rights and exercise of
  • Privacy and safety
  • Confidentiality of medical records
  • Restraint issues (50 pages of restraint
  • Grievances
  • Advance directives
  • Visitation rights

Standard 1
  • Notice of Patient Rights and Grievance Process
  • Hospital must ensure the notice of patient rights
    are met
  • Provide in a manner the patient will understand
  • Remember issue of limited English proficiency
    (LEP) as with patients who does not speak English
    and low health literacy
  • 20 of patients read at a fifth grade level
  • Must have PP to ensure patients have information
    necessary to exercise their rights

Notice of Patient Rights 116
  • Rule 1 - A hospital must inform each patient of
    the patients rights in advance of furnishing or
    discontinuing care
  • Must protect and promote each patients rights
  • Must have PP to ensure patients have information
    on their rights and this includes inpatients and
  • Must give Medicare patient IM Notice within two
    days of admission and in advance of discharge if
    more than two days

Notice of Patient Rights
  • Confidentiality and privacy
  • Pain relief
  • Refuse treatment and informed consent
  • Advance directives
  • Right to get copy for Medicare patients of
    Important Message from Medicare (IM Notice) or
    detailed notice)
  • Right to be free from unnecessary restraints
  • Right to determine who visitors will be

Notify Patient of Their Rights
  • When appropriate, this information is given to
    the patients representative
  • Document reason, patient unconscious, guardian,
    DPOA, parent if minor child et. al.
  • Consider having a copy on the back of the general
    admission consent form and acknowledgment of the
  • Have sentence that patient acknowledges receipt
    of their patient rights
  • Right to contact the QIO or state agency of

  • Rule 2 - A hospital must ensure interpreters are
  • Make sure communication needs of patients are
  • Recommend qualified interpreters
  • Must comply with Civil Rights law
  • Be sure to document that the interpreter was used
  • See TJC 2011 Patient Centered Communications

  • Consider posting a sign in several languages that
    interpreting services are available
  • Include in yearly skills lab for nurses to make
    sure your staff knows what to do and they
    understand PP
  • Review your policy and procedure and the five
    2011 standard TJC requirements
  • If hospital owned physician practices ensure
    interpreters are present in prescheduled

Grievance Process A-0118
  • Rule 3 - The hospital must have a process for
    prompt resolution of patient grievances
  • Hospital must inform each patient to whom to file
    a grievance
  • Provides definition which you need to include in
    your policy
  • If TJC accredited combine PP with complaint
    section complaint standard at RI.01.07.01 in
    which is similar to CMS now with one addition
  • Use the CMS definition of grievance

Grievance Process 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 patients representative,
  • regarding the patients care, abuse, or neglect,
    issues related to the hospitals compliance with
    the CMS CoP or a Medicare beneficiary billing
    complaint related to rights

Staff Present Grievances
  • Remember it is not a grievance if resolved by
    staff present
  • Document this in medical record
  • Expanded definition of what is meant by staff
  • Now includes any hospital staff present at the
    time of the complaint or who can quickly be at
    the patients location
  • Such as nursing administration, nursing
    supervisors, patient advocates or anyone else who
    can resolve the patients complaint

Grievances A-0118
  • Hospitals should have process in place to deal
    with minor request in more timely manner than a
    written request
  • Examples change in bedding, housekeeping of
    room, and serving preferred foods
  • Does not require written response
  • If complaint cannot be resolved at the time of
    the complaint or requires further action for
    resolution then it is a grievance
  • All the CMS requirements for grievances must be

Patient or Their Representative
  • If someone other than the patient complains about
    care or treatment
  • Contact the patient and ask if this person is
    their authorized representative
  • Get the patients permission to discuss protected
    health information with designed person because
    of HIPAA
  • Document in the file that the patients
    permission was obtained
  • Some facilities get a HIPAA compliant form signed

Grievances 0118
  • Not a grievance if patient is satisfied with care
    but family member is not
  • Billing issues are not generally grievances
    unless a quality of care issue
  • A written complaint is always a grievance whether
    inpatient or outpatient (email and fax is
    considered written)
  • Information on patient satisfaction surveys
    generally not a grievance unless patient asks for
    resolution or unless the hospital usually treats
    that type of complaint as a grievance

Grievances 0118
  • If complaint is telephoned in after patient is
    dismissed then this is also considered a
  • All complaints on abuse, neglect, or patient harm
    will always be considered a grievance
  • Exception is if post hospital verbal
    communication would have been routinely handled
    by staff present
  • If patient asks you to treat as grievance it will
    always be a grievance

Grievance Process - Survey Procedure
  • Review the hospital policy to assure its
    grievance process encourages all personnel to
    alert appropriate staff concerning grievances
  • Hospital must assure that grievances involving
    situations that place patients in immediate
    danger are resolved in a timely manner
  • Conduct audits and PI to make sure your facility
    is following its grievance PP

Grievance Process - Survey Procedure
  • Surveyor will interview patients to make sure
    they know how to file a complaint or grievance
  • Including right to notify state agency (state
    department of health and QIO with phone numbers)
  • Remember to add email address and address of both
  • Document that this is given to the patient
  • Remember the TJC APR requirements
  • Should be in writing in patient rights section

Grievance Process 0119
  • Rule 4 The hospital must establish a process
    for prompt resolution
  • Inform each patient whom to contact to file a
    grievance by name or title
  • Operator must know where to route calls
  • Make form accessible to all

Grievance Process A-0119
  • Rule 5 The hospitals governing board must
    approve and is responsible for the effective
    operation of the grievance process
  • Elevates issue to higher administrative level
  • Have a process to address complaints timely
  • Coordinate data for PI and look for opportunities
    for improvement
  • Read this section with the next rule
  • Most boards will delegate this to hospital staff

Rule 6 A-0119-120
  • The hospitals board must review and resolve
  • Unless it delegates the responsibility in writing
    to the grievance committee
  • Board is responsible for effective operation of
    grievance process
  • Grievance process reviewed and analyzed thru
    hospitals PI program
  • Grievance committee must be more than one person
    and committee needs adequate number of qualified
    members to review and resolve

Grievance Survey Procedure
  • Go back and make sure your governing board has
    approved the grievance process
  • Look for this in the board minutes or a
    resolution that the grievance process has been
    delegated to a grievance committee
  • Does hospital apply what it learns?

Grievance Process-A-0120
  • Rule 7 The grievance process must include a
    mechanism for timely referral of patient concerns
    regarding the quality of care or premature
    discharge to the appropriate QIO
  • Each state has a state QIO under contract from
    CMS and list of QIOs1
  • QIO are CMS contractors who are charged with
    reviewing the appropriateness and quality of care
    rendered to Medicare beneficiaries in the
    hospital setting
  • 1http//

IM and Detailed Notice Forms
  • Hospital to provide a Medicare patient with an
    Important Message from Medicare ( IM notice )
    within 48 hours of admission
  • The hospital must deliver to the patient a copy
    of this signed form again if more than two days
    and within 48 hours of discharge
  • About 1 of Medicare patients voice concern about
    being discharge prematurely
  • These patients must be given a more detailed
    notice and request the QIO to review their case
  • New forms IM You Have the Right and Detailed
  • Website for beneficiary notices1

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Grievance Procedure 121
  • Hospital must have a clear procedure for the
    submission of a patients written or verbal
  • Surveyor will review your information to make
    sure it clearly tells patients how to submit a
    verbal or written grievance
  • Surveyor will interview patient to make sure
    information provided tells them how to submit a
  • Must establish process for prompt resolution of

Hospital Grievance Procedure 0122
  • Rule 8 Hospital must have a PP on grievance
  • Specific time frame for reviewing and responding
    to the grievance
  • Grievance resolution that includes the patient
    with a written notice of its decision, IN MOST
  • The written notice to the patient must include
    the steps taken to investigate the grievance, the
    results and date of completion

Hospital Grievance Procedure
  • Facility must respond to the substance of each
    and every grievance
  • Need to dig deeper into system problems indicated
    by the grievance using the system analysis
  • Note the relationship to TJC sentinel event
    policy and LD medical error standards, CMS
    guidelines for determining immediate jeopardy,
    HIPAA privacy and security complaints, and risk
    management/patient safety investigations

  • Timeframe of 7 days would be considered
    appropriate and if not resolved or
    investigation not completed within 7 days must
    notify patient still working on it and hospital
    will follow up
  • Most complaints are not complicated and do not
    require extensive investigation
  • Will look at time frames established
  • Must document if grievance is so complicated it
    requires an extensive investigation

Grievances A-0123
  • Explanation to the patient must be in a manner
    the patient or their legal representative would
  • The written response must contain the elements
    required in this section - not statements that
    could be used in legal action against the
  • Written response must the steps taken to
    investigate the complaint
  • Surveyors will review the written notices to make
    sure they comply with this section

Grievances A-0123
  • CMS says if patient emailed you a complaint, you
    may email back response
  • Be careful as many hospital policy on security do
    not allow this since email is not encrypted
  • Must maintain evidence of compliance with the
    grievance requirements
  • Grievance is considered resolved when patient is
    satisfied with action or if hospital has taken
    appropriate and reasonable action

TJC Complaint Standard
  • TJC has complaint standard RI.01.07.01 with
    changes 7-01-09 and 2 010 and continued in 2011
  • Will not cover but provided for reference
  • TJC calls them complaints
  • CMS calls them grievances
  • TJC has eliminated several standards in 2011 that
    are still CMS standards
  • More closely cross walked now

RI.01.07.01 Complaints Grievances
  • Standard patient and or her family has the right
    to have a complaint reviewed, (RI 2.120
  • EP1 Hospital must establish a complaint and
    grievance (CG) resolution process
  • See also MS.09.01.01, EP1
  • EP2 Patient and family is informed of CG
    resolution process
  • EP4 Complaints must be reviewed and resolved when

RI.01.07.01 Complaints Grievances
  • EP6 Hospital acknowledges receipt of CG that
    cannot be resolved immediately
  • Hospital must notify the patient of follow up to
    the CG
  • EP7 Must provide the patient with the phone
    number and address to file the CG with the
    relevant state authority
  • EP10 The patient is allowed to voice CG and
    recommend changes freely with out being subject
    to discrimination, coercion, reprisal, or
    unreasonable interruption of care

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
  • 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 grievance
  • Results of the process
  • Date of completion of the grievance process

RI.01.07.01 Complaints
  • EP19 Hospital determines the time frame for
    grievance 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
  • EP21 Board approves the CG process (eliminated
    but still CMS standard)

Have a Policy to Hit All the Elements
2cd Standard Exercise of Rights
  • Right to participate in the development and
    implementation of their plan of care
  • Right to refuse care and formulate advance
  • Right to have a family member or representative
    of his or her choice notified if requested
  • Called support person in the final visitation
  • Right to have his or her physician notified
    promptly of the patient's admission to the
    hospital if patient requests this

Standard 2 Exercise of Rights 0129
  • Rule 1 Patients have the right to participate
    in the development and implementation of their
    plan of care
  • Includes inpatients and outpatients
  • Includes discharge planning and pain management
  • Requires hospital to actively include the patient
    in developing their plan of care including changes

Patient Participate in Plan of Care
  • If patient refuses to participate, document this
  • Include patients legal representative if patient
    minor or incompetent
  • Plan of care is frequently cited
  • Patients needing post-hospital care are given
    choice home health or nursing homes
  • Includes choice to pain management, patient care
    issues, and discharge planning
  • Section 1802 of SSA guarantees free choice by
    Medicare patients for LTC or home health

Rule 2 - Patients Have a Right
  • To make informed decision regarding their care
  • Being informed of their diagnosis and prognosis
  • To request or refuse treatment
  • Right to sign out AMA
  • Remember EMTALA requirements if patient is
  • Have patient sign the transfer agreement

Informed Consent 0131
  • CMS has 3 sections in the hospital CoP manual on
    informed consent
  • Section on informed consent in patient rights on
    informed decisions, medical records and surgical
  • The patient has the right to make informed

Informed Consent 0131
  • Right to delegate the right to make informed
    decisions to another (DPOA, guardian)
  • Patient has a right to an informed consent for
    surgery or a treatment
  • Right to be informed of health status and to be
    involved in care planning and treatment
  • Informed decision on discharge planning to post
    acute care
  • Right to request or refuse treatment and PP to
    assure patients right to request or refuse

Informed Consent
  • Right to informed decisions about planning for
    care after discharge
  • Right to receive information in a manner that is
    understandable (issue of healthcare literacy)
  • Right to get information about health status,
    diagnosis and prognosis
  • Hospital has to have process to ensure these
  • Required to have policies and procedures on all
    of these

Disclosures to Patients 131
  • There are two disclosures that must be in writing
  • If physician owned hospital
  • If a doctor or an ED physician is not available
    24 hours a day to assist in emergencies
  • Must provide information at beginning of
    inpatient stay or visit
  • Includes notice in your general consent
    form/notice of privacy practice that all
    inpatients and outpatients sign

Patient Rights 0132
  • Right to make and have the advance directives
    followed when unconscious or incapacitated
  • Staff must provide care that is consistent with
    these directives
  • PP must include delegation of patient rights to
    representative if patient incompetent
  • Note rights as inpatient outpatient AD
    requirements of Joint Commission

Advance Directives
  • Your policy should have clear statement of any
    limitations such as conscience
  • At a minimum, clarify any difference between
    facility wide conscience objections and those
    raised by individual doctors
  • You must provide written information to the
    patient on their rights under state law, at time
    of admission
  • Both inpatients and outpatients have rights but
    dont have to give it in writing to outpatients
  • Document whether or not they have an AD

Advance Directives 132
  • Cannot condition treatment on whether or not they
    have one
  • Not construed as a mechanism to demand
    inappropriate or medically unnecessary care
  • Ensure compliance with state laws on AD
  • Inform patients they may file with state survey
    and certification agency
  • Provide and document advance directives education
  • Staff on PP and community

Patient Rights
  • Includes the right for medical decisions such as
    pain management
  • Disseminate policy on advance directive, identify
    state authority permitting an objection
  • Includes Psychiatric or behavioral health AD
  • The visitation regulations are one of the newest
    patient rights

3rd Standard Privacy and Safety 143
  • The right to personal privacy
  • To receive care in a safe setting
  • To be free from all forms of abuse or harassment
  • Rule 1 The right to personal privacy
  • Right to respect, dignity, and comfort
  • Privacy during personal hygiene activities
    (toileting, bathing, dressing, pelvic exam)

Personal Privacy
  • Person not involved with care may not be present
    while exam is being done unless consent required
    (medical students who are observing not those
    caring for patient)
  • Need consent for video/electronic monitoring
  • Such as cameras in patient rooms (sleep lab, ED
    safe room, eICU) and not in hallways or lobbies
  • Include in your general admission consent form
    that all patients sign on admission or make sure
    patients are aware such in ICU

Personal Privacy
  • Surveyor will conduct observations to determine
    if privacy provided during exams, treatments,
    surgery, personal hygiene activities, etc.
  • Surveyor will look to see if names or patient
    information is posted in plain view
  • Survey procedure will ask if patient names are
    posted in public view
  • No white boards with patient names and other PHI

Privacy and Safety 144
  • Rule 2 The right to receive care in a safe
  • Includes following standards of care and practice
    for environmental safety, infection control, and
    security such as preventing infant abductions,
    preventing patient falls and medication errors
  • Very broad authority for patient safety issue
  • Right to respect for dignity and comfort

Care in a Safe Setting
  • Includes washing hands between patients - see CDC
    or WHO hand hygiene and TJC Measuring Hand
    Hygiene Adherence
  • Review and analyze incident or accident reports
    to identify problems with a safe environment
  • Review policies and procedures
  • How does facility have PP to curtail unwanted
    visitors or contraband materials

Privacy and Safety 145
  • Rule 3 The patient has the right to be free
    from all forms of abuse or harassment and neglect
  • Must have process in place to prevent this
  • Criminal background checks as required by your
    state law
  • Must provide ongoing (yearly) training on abuse,
    harassment, and neglect

Privacy and Safety 145
  • Consider annual training in yearly skills lab
  • Must have PP on this
  • Adequate staffing section
  • Have proactive approach to identify events that
    could be abuse
  • TJC and CMS have definitions of what is abuse and

Freedom From Abuse and Neglect
  • Abuse is defined as the willful infliction of
    injury, unreasonable confinement, intimidation,
    or punishment, with resulting physical harm,
    pain, or mental anguish
  • Includes staff neglect or indifference to
    infliction of injury or intimidation of one
    patient by another
  • Include state laws in your PP on abuse and
  • Remember TJC has standard and definitions,

Freedom From Abuse and Neglect
  • Neglect is defined as the failure to provide
    goods and services necessary to avoid physical
    harm, mental anguish, or mental illness
  • Investigate all allegations of abuse or neglect
  • Do not hire persons with record of abuse or
  • Report all incidents to proper authority, board
    of nursing, etc.

Freedom From Abuse and Neglect
  • Includes freedom abuse from not just staff but
    other patients and visitors
  • Hospital must have a mechanism in place to
    prevent this
  • Effective abuse program includes prevention
  • Adequate number of staff who have been screened
  • Identify events that could lead to or contribute
    to abuse
  • Protect during investigation
  • Investigate and report and respond

Abuse and Neglect
  • Make sure you have a policy in place for
    investigating allegations of abuse
  • Make sure staffing sufficient across all shifts
  • Make sure appropriate action taken if
  • Make sure staff know what to do if they witness
    abuse and neglect

TJC Abuse and Neglect
  • Remember to include Joint Commissions standard,
    RI.01.06.03, and definitions of abuse and neglect
    into your policy also if accredited
  • Patients have the right to be free from abuse,
    neglect, and exploitation
  • This includes physical, sexual, mental, or verbal
    abuse and Joint Commission has definitions for
    all of these terms

TJC Abuse and Neglect
  • Determine how you will protect patients while
    they are receiving care from abuse and neglect
  • Evaluate all allegations that occur within the
  • Report to proper authorities as required by law

Standard 4 Confidentiality
  • Rule 1 Patients have a right to
    confidentiality of their medical records and to
    access of their medical records (0146)
  • Sufficient safeguards to ensure access to all
  • HIPPA compliant authorization for release
  • MR are kept secure and only viewed when necessary
    by staff involved in care
  • Do not post patient information where it can
    viewed by visitors
  • TJC IM.02.01.01 standard requires that hospital
    protects the privacy of health information,
    maintain security of same (white boards)

Patient Records
  • Rule 2 Patients have the right to access the
    information contained within their medical
  • Right to inspect their record or to get a copy
  • 30 day rule under HIPAA unless state law or PP
    more stringent
  • Limited exceptions such as psychotherapy notes,
    prisoners if jeopardize health of themselves or
    others, information could cause harm to another,
    under promise of confidentiality, etc.

Access to Medical Records (PHI)
  • Rule 3 Access to the medical record must be
    within a reasonably time frame and hospitals can
    not frustrate efforts of patients to get records
  • If patient is incompetent then to the personal
    representative and should sign as the personal
    representative such as guardian, parent, or DPOA
  • Reasonable cost for copying, postage or summary
  • no retrieval fee allowed under federal law

5th Standard Restraints 0154-0214
  • Many changes were made
  • Combined the two sections on medical surgical and
    behavioral restraints into one section
  • Changes went into effect January 8, 2007 and 50
    pages of interpretive guidelines April 11, 2008
    and 10-17-08 and references added 6-5-09
  • Need to rewrite policies and procedures and
    train all staff

Restraint Worksheet
  • CMS has restraint worksheet1 which is not an
    official OMB form
  • Cannot mandate hospital fill out but will save
    time on phone from them asking you the
  • Must still notify regional office by phone the
    next business day
  • Document this in medical record
  • CMS has manual to address complaint surveys
  • Put regional office contact information in your

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  • New changes only affect regular hospitals and
    Critical Access Hospitals have own manual
  • CAH do not have a patient rights section and not
    required to follow new RS section
  • CAH must have PP so they can either use TJC
    standards or select some or all of hospital ones
  • Some CAH have adopted all if in system with
    regular hospitals

Standard 5 Restraints
  • Rule 1 Patients have a right to be free from
    physical or mental abuse, and corporal punishment
  • This includes that restraint and seclusion (RS)
  • Will only be used when necessary
  • Not as coercion, discipline, convenience or
  • Only used for patient safety and discontinued at
    earliest possible time
  • RS guidelines from CMS apply to all hospital
    patients even those in behavioral health

Right to be Free From Restraint
  • Hospitals should consider adding it to their
    patient rights statement if not already there
  • Patients are required to be provided a copy of
    their rights (staff must document or have patient
    sign that they received their rights)
  • Could include information in admission packet
  • If patient falls do not consider using RS as
    routine part of fall prevention (154)

Rule 2 Hospital Leaderships Role
  • Like TJC, leadership is responsible for creating
    a culture that supports right to be free from RS
  • LD must make sure systems and processes in place
    to eliminate inappropriate RS and monitors use
    thru PI process
  • LD makes sure only used for physical safety of
    patient or staff
  • LD ensure hospital complies with all RS
    requirements (154)

Restraints Protocols
  • CMS previously did not recognize or allow the use
    of protocols like Joint Commission does
  • Protocols are now not banned by the new
    regulations (168) but still need separate order
    for RS
  • Must contain information for staff on how to
    monitor and apply like intubation protocol

  • Requires an order even with a protocol is
    basically the same process hospitals were doing
  • Medical record must include documentation of
    individualized assessment, symptoms and diagnosis
    that triggered protocol
  • Need MS involvement in developing and review and
    quality monitoring of their use

Restraint Standards
  • If a patient becomes violent or has self
    destructive behavior (V/SD) in the ICU or ED, CMS
    has one set of standards that apply
  • Decision to use RS is not driven from diagnosis
    but from assessment of the patient
  • TJC standards changed July 1, 2009
  • 10 new standards
  • All the 2009 RS standards were eliminated except
    two (forensic and one on behavioral management)
    for hospital who use TJC for deemed status

Restraint Standards Medical Patients
  • Joint Commission calls it