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									CMS CoP for Critical Access Hospitals

                  PART 1

    What every CAH needs to know about the
       Conditions of Participation 2011

 TELNET 2705 October 6, 2011 10-11:30 am EDT

                  Sue Dill Calloway RN, Esq.
                  AD, BA, BSN, MSN, JD
                  Chief Learning Officer
                  Emergency Medicine Patient
                  Safety Foundation
                  614 791-1468
You Don’t Want One of These


Mandatory Compliance
            Hospitals that participate in
            Medicare or Medicaid must
            meet the Conditions of
            Participation (COPs) for all
            patients in the facilities and not
            just those who are Medicare or
            Medicaid patients,
            Hospitals accredited by Joint
            Commission, AOA, or DNV
            Healthcare have what is called
            deemed status,
CAH Problematic Standards
 Date and time on all orders and entries
 Verbal orders
 Informed consent
 Plan of care
 Handling, dispensing, storage and
 administration of medications
 Meeting the nutritional needs of patients
 Healthcare services in accordance with P&P

CAH Problematic Standards
 Medical record documentation must reflect
 the nursing process
 Legibility of the medical record
 Equipment and supplies used in life saving
 R&S for PPS hospitals but CAH still need to
 do something
 Infection control issues
 What else should we add???
Small or Rural Hospitals
 American Hospital Association has Web site
 with good information for CAH
 Has recent issues of interest to CAH
 Excellent resources including current list of
 all CAHs in the US
 Has CAH newsletters
   go to


AHA CAH Resources


CMS Regional Offices


AHA Critical Access Website


Rural Assistance Center


CMS CAH Website
 CMH has a website for resources
    State operations manuals
    Program transmittals
    Guidance for laws and regulations for
    Medicare Learning network
    Other helpful information


CMS CAH Website


Critical Access Hospitals
 Only 3 of 9 changes in hospitals CoPs affected
 hospitals and that was the Medicare Discharge Appeal
 Rights, Visitation and the telemedicine and proposed
 QIO and SA notification and proposed flu standards
 Confusing when CMS says hospitals must do this but
 will specifically mention CAH must do…….
 Verbal order Tag Number 297,
 H&P 320,
 Informed consent 304 and 320,
 Security of Medications 276,
 Anesthesia assessments 321,
 Infection control 278 but you should still look at these!

Infection Control

  Memo 08-04,                  1

  Updated to reflect changing infectious and
  communicable disease threats,
  Including current knowledge and best
  This is why CAH should still look at this
  1 Available at,

Infection Control
  Changes in interpretive guidelines, 12 pages,
  This means technically only applies to PPS
  hospitals and not CAH,
  Active infection control program,
  Investigations and control of infections,
  Infection control log,
  CEO, CNO, and MS must ensure hospital
  wide training program and correction plan for
  problem areas,


The Conditions of Participation CoPs
 First, published in the Federal Register-42 CFR
Part 482.
    Federal Register available at no charge at
 Next, CMS publishes Interpretive Guidelines
and some include survey procedures,
    This is an important Web site to keep in your
  Current CoP issued June 12, 2009







How to Find Changes
 Have one person in your facility who
 goes out to this website once a month
 and checks for updates.
 You can do a search for time frame and
 can add words to search,
   Such as CAH
   Click on fiscal year to bring up most current
CMS Survey and Certification Website



CMS Transmittals


Sample CMS Memo


CAH Regulatory Changes
 This 10 page memo was is example of an update
 found and is part of CAH CoP manual,
 Issued December 31, 2009 because 2 changes in
 2010 IPPS rules,
 Allows continued participation for two years of
 CAHs located in areas no longer rural (several
 rural locations were now classified as MSA or
 Metropolitan Statistical Area)
 Requires all CAH owned labs to satisfy provider
 based and CAH location requirements


Rehab or Psych Distinct Unit
 If a CAH operates an off-campus provider
 based facility then it must be no more than
 35 mile drive (or 15 mile if mountainous
 terrain or with only secondary roads) from
 another hospital or CAH,
 Unless in existence before January 1, 2008,
 Also remember that any CAH with up to ten
 bed rehab or behavioral health distinct unit
 must follow the PPS Hospital CoPs and not
 the CAH CoPs for these two units,
CMS Hospital CoPs
  Appendix W, Tag C-0150 to C 0408,
  Interpretive guidelines updated 6-12-09,
  About 206 pages long,
  Manual includes swing beds in CAHs,
  Consider doing a gap analysis,
  Take each section and on left hand side of
page document how you comply with each
 Time consuming but will help with compliance,

CMS Hospital CoPs
  Consider doing a gap analysis,
  Take each section and on left hand side of
page document how you comply with each
 Time consuming but will have with compliance,
  Include policies and yellow section that
corresponds to the required P&P in the CoP
  Have one person in charge who can keep up with
changes and who knows what to do if CMS shows
up for validation or complaint survey
Rehab or Behavioral Health Dept CAH
 Remember, CAH rehab or psych
 (behavioral health) is surveyed under
 the regular hospital CoP program even
 though CAH has a separate manual,
 Final interpretive guidelines for regular
 hospitals was published June 5, 2009 and
 anesthesia updated and revision February
 14, 2011, Rehab and Respiratory orders and
 visitation 2011, blood & IV Medication 2011

TJC Revised Requirements
 TJC or the Joint Commission (not called
 JCAHO anymore) has made many changes
 to bring their standards into closer alignment
 with CMS
 Having less differences is helpful to
 Have some that are for hospitals that use
 them to get deemed status (DS) or payment
 for M/M patients,
    Will specify DS after the standard

Changes Since the Current Manual
 As previously mentioned, the current manual
 was published June 9, 2009
 The visitation regulation became effective on
 January 19, 2011
   Interpretive guidelines expected out soon
 The telemedicine regulations are effective
 July 5, 2011 and IG issued July 15, 2011
 QIO and state agency notice changes and
 flu standards are proposed

 CMS Proposed New Rule
  CMS proposed new rule for notifying
  beneficiaries of their right to file a quality of
  care complaint
     Give beneficiaries written notice of their right to
     contact their state QIO or Quality Improvement
     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 QIO
  The proposed rule was published in the
  Federal Register on February 2, 2011
  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 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 QIO
     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 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, CAH
 hospitals, 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

Proposed Influenza Vaccination
 May 4, 2011, CMS issued a proposed rule
 CAH would have to offer all inpatients and
 outpatients an annual flu vaccination
 CAH would need a P&P to offer annual
 vaccination for seasonal and pandemic flu
 Patients would receive education on
 benefits, risks, and potential side effects of
 the vaccine
 Patient can decline and must document in
 medical record

May 4, 2011 FR on Flu Vaccinations


Visitation Law in a Nutshell
                  Require all hospitals that
                  accept Medicare or Medicaid
                  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
 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
 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


Final Rule FR Effective January 18, 2011

Final Language 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
    Or reasonable restriction or limitation that
    the hospital may need to place on such
     And the reasons for the clinical restriction
    or limitation

Final Language Patient Visitation Rights
  A hospital must meet the following 4
1.Inform each patient (or support person, where
  appropriate) of his or her visitation rights
    Including any clinical restriction or limitation on such
    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-exisiting patient rights
Final Language 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
    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 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
  All hospitals would have to inform all patients of
  their visitation rights in writing in advance of care
  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

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
    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 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


Telemedicine Rule in a Nut Shell
 The final rule would revise the hospital CoP
 For both PPS and CAH Hospitals
   Would allow hospital to rely on information provided
   from another entity to base credentialing and
   privileging decision regarding physicians who use
   telemedicine at their facility
 Would allow “privileging by proxy” so hospital
 could accept the privileging decision of another
 Medicare hospital or telemedicine entity
 Discusses what board must include in the
 contract with the other hospital or entity
CMS Telemedicine
 The new rule would still allow hospitals to use a
 third party credentialing verification organization to
 compile and verify the credentials of practitioners
 The hospital's governing body would still
 responsible for making all privileging decisions
 Physician would still need to hold a license in the
 state where the hospital receiving the telemedicine
 service is located
 MS makes the recommendation to the board
 Must ensure contract has language to allow CAH to
 meet the hospital CoPs

CMS Telemedicine
 CAH would have to let other distant-site
 hospital (DSH) or distant-site telemedicine
 entity (DSTE) know if any complaints or
 adverse events occurred
 The other entity can use this information in
 the periodic performance appraisal of the
 Easier to allow CAH to rely on the C&P of
 the other facility and to provide a copy of
 those privileges to the CAH
Condition Level Requirement Noncompliance


  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
  Standard level- noncompliance as above
but not of such a character to limit facility’s
capacity to furnish adequate care- no
jeopardy or adverse effect to health or safety
of patient,
  Medicare CoPs are found at 42 CFR Part
  485 Subpart F.
  Authority to make copies of things is at 42
  CFR 489.53,
    Recommend you have surveyor make you a
    copy also,
    Please ask surveyor not to make copy of peer
    review material not to copy-abstract out what is
  Can get all CFR now electronically off Internet free at GPO access at
    Click on Code of Federal Regulations and can do search or click on e-CFR, or,

Resources to Keep Handy
 Appendix W Hospital CoPs (“C”)
  Unless CAH has a separate rehab or behavioral health unit
 and then you need Appendix A- Hospital CoP also for these

 Survey protocol and module,
 Q- Immediate jeopardy.
 T-Hospital swing beds-if you have these,
 B- Home health
 I-Life safety code
Survey Procedure
 The interpretive guidelines provide instructions to
 the surveyors on how to survey the CoPs-like
 questions to the test,
 They have survey procedure instructions to
 determine the hospital policy for notifying patients
 of their rights,
 Ask patients to tell you if the hospital told them
 about their rights,
 Deficiency citation show how the entity failed to
 comply with regulatory requirements and not the

Interpretive Guidelines

 Surveyors use the information contained in
 the interpretive guidelines,
 But must be cautious,
 Do not replace or supersede the law,
 Not used as basis for citation,
  However do contain authoritative
 interpretations and clarifications,
 Can assist surveyors in making
 determinations of compliance,
What’s Really Important!
 Life Safety Code Compliance,
 Infection Control,
 Patient Rights especially R&S and
 grievances (not a patient rights chapter
 in CAH manual),
 Performance Improvement (called
 Dietary and cleanliness of dietary,
 EMTALA (updated May 29, 2009)

Survey Protocol
  First 26 pages list the survey protocol,
 Includes a section on:
  Off-survey preparation,
  Entrance activities,
  Information gathering/investigation,
  Preliminary decision making and
analysis of finding,
  Exit conference,
  Post survey activities,
Survey Protocol
 Survey done thru observation, interviews,
and document review,
 Monday-Friday but can come
 Do not refuse access or you will be
excluded from getting any money for
Medicare/Medicaid patients,
 Federal law allows CMS or department of
health surveyors access to your facility,


Survey Team
  SA (state agency) decides or RO (regional
office) for federal teams decides composition
and size of team,
  Usually 1-4 surveyors for 1 or more days,
  At least 1 RN with hospital/CAH survey
  Team based on complexity of services
  Depends on if complaint or validation survey
or recertification,
Task 1 Off Site Survey Prep

   Surveyor gathers information about provider
 (ownership, types of services offered, locations,
 any swing beds, number of beds, previous survey
   Any distinct units, any previous complaints,
   Waivers and variances, if any,
   Information from CMS database and may look at
   hospital website (includes directions to the
   Previous surveys and findings such as any


Task 2-Entrance Activities
  Explain survey process to hospital,
  Team should enter together,
  Usually goes to administration, present their
  Explain purpose and scope of survey,
  ENTRANCE CONFERENCE-sets tone for entire
  Give surveyors conference room, telephone,
  Give names of department heads, their location
and phone numbers,
  Organizational chart,
Task 2-Entrance Activities

   All CAH areas and locations, departments, and
  patient care settings under the CAH provider
  number may be surveyed,
  Includes any contracted patient care activities or
  patient service,
  All interviews will be conducted privately with
  patients, staff, and visitors,
  Will discuss and determine how the facility will
  ensure that surveyors are able to get
  photocopies of material, records, and other
  information as they are needed,

Task 2-Entrance Activities
 Get 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, scope of services,
 List of current patients with room numbers,
Task 2-Entrance Activities
 Give preliminary date and time for exit
 Makes initial patient sample selection-
 will pick cross section of patient
 population and services provided,
 Includes inpatients and outpatients and
 , closed records of discharges,
 Sample needs to be no fewer than 20
 inpatient records,

Task 3 Information Gathering
  Purpose is to determine compliance with CoPs
thru observation, interviews, and document review,
 Focus is on outcomes,
  Will visit patient care areas including ED and
  outpatient, Imaging, rehab, and remote
 Observe actual care, Provide copies of materials,
 Use interpretive guidelines to guide survey,
 Use Appendix Q if Immediate Jeopardy is

Task 3 Information Gathering

  Surveyor has discretion whether to allow
  staff to accompany the surveyor,
  All significant adverse events should be
  brought to the team coordinator’s attention
  Surveyors must respect patient privacy and
  However, work with surveyor so they do not
  take peer protected documents with them,

Task 3 Information Gathering
  Will do comprehensive review of care and
  services rendered by each patient in sample,
  Will observe patient care treatments, staff
  activities, documentation, policies and
  Observe storage and security of medical
  Whether QA is facility wide,
  Interview staff such as if you smell smoke what
  would you do?
  Interview patients regarding their knowledge of
  their plan of care,
Document Review

  Patients records and closed records,
  Personnel files for proper education and training,
  Credential files to follow CMS requirements and
  own policies for MS privileging,
  Policy and procedure manual,
  Diet menus and Contracts,
  Maintenance records to determine if equipment
  periodically examined,
  Photocopies need to be dated and timed as to
  when copied,


Task 4 Preliminary Decision
   Preliminary Decision Making and Analysis of
   Review and analyze all information gathered,
   Determine if CoPs are met (42 CFR Part
     Prepare exit conference report,
   If noncompliance with CoP then determine if at
 standard or condition level and how dangerous it
   All noncompliance must be cited even if
   corrected on site,

   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,
   Standard level- noncompliance as above but not
 of such a character to limit facility’s capacity to
 furnish adequate care- no jeopardy or adverse
 effect to health or safety of patient,


Task 5- Exit Conference

  Objective is to inform facility of preliminary
 Policy is to do exit conference but can refuse if
hostile environment or counsel tries to turn into
evidentiary hearing,
  If record must provide two tapes and tape
recorders and tape at same time- give surveyor
 Official findings are provided in writing on Form
CMS 2567,

Task 5- Exit Conference
  Surveyor can set ground rules,
  Present findings of noncompliance and why
are a violation,
  Statement of deficiencies will be mailed
within 10 working days (form 2567),
  This form is made public no later than 90
days after survey,
  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,
 See 42 CFR Part 488,
 Notify staff regarding survey results,
 Enter information into hospital/CAH Medicare
 Certification of providers with deficiencies if
acceptable plan of correction,
  Failure to submit acceptable plan of correction can
result in termination of provider agreement
Swing Bed Module
When patients need brief transitional care at the
hospital at the end of their acute care stay,
If swing beds then do survey under CAH swing-
bed requirements found at 42 CFR Part
Reimbursement is for Skilled Nursing care as
opposed to Acute Care,
  Term is for reimbursement and has no
relationship to geographic location in the
.                                             81

Swing Bed Module
 May be in acute care status one day
 and then in swing bed status the next
 3-day qualifying stay for the same spell
 of illness in any hospital or CAH is
 required prior to admission to swing-
 bed status,
 Actual swing-bed survey requirements
 are referenced in the Medicare Nursing
 Homes requirements at 42 CFR Pt 483
Swing Bed Module
The total number of beds that may be used at any
time for furnishing swing-bed services or acute
inpatient services does not exceed 25 beds,
The CAH meets the swing-bed CoP on Resident
Rights; Admission, Transfer, and Discharge
Rights; Resident Behavior and Facility Practices;
Patients Activities; Social Services; Discharge
Planning; Specialized Rehabilitative Services;
and Dental Services
The hospital’s swing-bed approval is in effect and
has not been terminated within the two previous

Swing Bed Counts
 Surveyor will verify 25 bed rule,
 Will count inpatient beds but not observation beds,
 Does not count OR, PACU, L&D, newborn nursery
 or ED stretchers, exam tables, or observation beds
 Do count birthing beds where patients remain after
 giving birth,
 Do not count beds in Medicare certified rehab or
 psychiatric distinct part units,
 Will conduct open record review on all swing bed
 Swing bed deficiencies are documented on a
 separate form even though survey done
Regulation/Interpretive Guidelines

  Starts with a tag number, example C-0150,
  C refers to the CAH CoPs,
  Recall first is the section from federal register
(CFR) such as 485.608,
  Some have a section called the “interpretive
  Some have a section called “Survey Procedure”
and will explain how it is surveyed or what policies
will be reviewed, what questions to ask or
documents to look at,


Compliance with Laws C-150
 The CAH must be in compliance with all
 federal, state, and local laws,
 Survey procedure tells surveyor to interview
 CEO or other designated by hospital, to
 determine this,
 Refer non-compliance to proper agency with
 jurisdiction such as OSHA
    TB, blood borne pathogen, universal
    precautions, or EPA (haz mat or waste
Compliance with Laws/Licensure

Patient care services must be provided with in
accordance with laws (152),
Ensure delegating as allowed by law,
Ensure practicing according to scope of
practice, such as NP, CNS, PA,
Hospital must be licensed (153)
Personnel must be licensed or certified if
required by state (doctors, nurses, PT, PA, OT,
x-ray tech. et. al.),
Review sample of personnel files to be
credentials and licensure is up to date,

Status/Location 160
If CAH moves then status and location must be
reassessed (harder to relocate now, see tag 166
on relocation)
Many changes to relocation and allows for
grandfathering (see SOM Manual 2)
Criteria for determining mountainous terrain,
revised definitions of primary and secondary
roads, documentation needed to relocate CAH
and 75% rule,



Status/Location 161/162/165
CAH must be outside a MSA or Metropolitan
Statistical Area
 Requirement to be 35 miles from another hospital or
within 15 minute drive if the terrain was mountainous
or in areas with only secondary roads,
Or allowed as a necessary provider designation-not
allowed after 1-01-06,
Grandfathers hospitals as of 1-01-06,
If CAH wants to locate will have to same provider
providing care to same location and RO decides (75%
of same population, staff, and services),
In 2008 outpatient PPS rules also and 2009 manual,
Off-Campus and Co-Location 167
 If CAH shares a campus with another
 hospital or CAH,
 The necessary provider CAH can continue
 to meet the location requirement if co-
 location was in effect before 1-10-09
 Must not have changed the type and scope
 of services provided
 Generally CAH can be co-located with
 another hospital because violates minimum
 distance requirements


Off-Campus and Co-Location 167
 However, some CAH were designated by
 the state as necessary providers before 1-1-
 This made them exempt from the 35 mile
 So some chose to co-locate with another
 hospital and might share the campus with an
 unrelated psychiatric or rehab hospital
 1-1-08 grandfathered necessary provider
 CAH could no longer enter into co-location
Off-Campus and Co-Location 167
 However, those in effect before 1-1-08 are
 grandfathered in and allowed to continue as
 long as did not change type or scope of
 services provided
 Determination of whether CAH is
 grandfathered in is made by regional office
 If CAH out of compliance with off campus
 location requirements can lose Medicare
 agreement unless terminates off campus

Agreement with Network Hospitals 190
 CAH that is a member of a rural network
 must have agreement with at least one
 hospital that is a member of the network
 A CAH must develop agreements with an
 acute care hospital related to patient
 referral and transfer, communication,
 emergency and non-emergency patient
 Will ask how CAH communicates with other
 hospitals- do you keep a communication
Working with the Other Hospital
 What P&P related to communication
 Will review any written agreements with
 local EMS
 Need to provide for transport between
 the two facilities
 Do the two hospitals have electronic
 sharing of patient data, telemetry and
 medical records? (193)

Credentialing and QA Agreement 195
 The CAH has to have an agreement with their
 referral hospital for quality improvement or choose
 to have that agreement with another organization.
    State networking requirements vary.
 With respect to credentialing and QA,
 Agreement for QA need to include a medical
 record review as part of quality and to establish
 medical necessity of care at CAH,
 Surveyor will review P&P to determine how
 information is obtained, used and how
 confidentiality is maintained,
Telemedicine July 15, 2011


Agreements for C&P 196
 Board must make sure agreement with
 distant-site hospital (DSH) or distant-site
 telemedicine entity (DSTE)
 Decide what category of practitioners are
 eligible for appointment to the MS
 Board appoints with recommendation of the
 Board approves the MS bylaws and other
 MS rules and regulations

Agreements for C&P 196
 Make sure MS is accountable to the board
 for quality of care provided to the patients
 Must have and follow criteria for selection of
 MS that is based on individual character,
 competence, training, experience, and
 Make sure under no circumstance is
 privileges based solely on certification,
 fellowship, or membership in a special body
 or society

197 Telemedicine C&P

Emergency Services 200
  Must provide emergency care necessary to meet
  the needs of its inpatients and outpatients,
  The ED cannot be a provider-based off-site
  Must comply with acceptable standards of
  Including those established by national
  professional organizations such as ACEP, ENA,
  ACS, ANA, AMA, American Association for
  Respiratory Care,


Emergency Services
 Need qualified medical director,
 MS must have P&P regarding the care
 provided in the ED,
 Policies current and revised based on QA
 MS must establish qualifications to get
 privileges to provide ED care,
 ED must be adequately staffed,
 Must have adequate equipment,

Emergency Services 200

 Must determine the categories and
 numbers of staff needed in the ED
 (MD/DO, RN, EMTs),
 The scope of diagnostic and/or
 therapeutic respiratory services offered
 by the CAH should be defined in
 writing, and approved by the medical
 staff (CT scans, venous dopplers,
 ultrasound et. al.),

14 ED Policies (Respiratory)
 P&P must be developed approved by
 And mid-level practitioners who work in
 the ED,
 Need triage procedures,
 Each type of service provided,
 Qualifications, education, training, of
 personnel authorized to perform
 respiratory care services and if
 supervision is needed,
ED Staff Training
Surveyor will interview ED staff to make sure
 knowledgeable including (so include in
 education of ED staff):
1. Parenteral administration of electrolytes,
   fluids, blood and blood components;
2. Care and management of injuries to
   extremities and central nervous system;
3. Prevention of contamination and cross
   infection; and
4. Provision of emergency respiratory

ED Staff Training
• Equipment assembly and operation;
• Safety practices, including infection control
• Handling, storage, and dispensing of
  therapeutic gases;
• Cardiopulmonary resuscitation;
• Procedures to follow in the advent of adverse
  reactions to treatments or interventions;
• Pulmonary function testing;
ED Staff Training
• Therapeutic percussion and vibration;
• Bronchopulmonary drainage;
• Mechanical ventilatory and oxygenation
• Aerosol, humidification, and therapeutic
  gas administration;
• Administration of medications; and
• Procedures for obtaining and analyzing

EMTALA and ED 24 hours
  Must still meet EMTALA (anti-dumping)
  Revised May 29, 2009 into 64 pages,
  Must have 24 hour ED services available,
  A CAH without inpatients is not required to
  have emergency staff on site 24 hours a day
  (If no patients, CAH may close),
  Can have NP, PA, or MD on site within 30
Availability of Drugs 201

 CAH must maintain the types, quality and
 numbers of supplies, drugs and biologicals,
 blood and blood products, and equipment,
 Required by state and local law and in
 accordance with accepted standards of
 Surveyor will ask how you make sure
 equipment, supplies, and medications are
 always available,


Emergency Drugs 203
 Drugs used in life-saving procedures,
 includes; analgesics, local anesthetics,
 antibiotics, anticonvulsants, antidotes and
 emetics, serums and toxoids, antiarrythmics,
 cardiac glycosides, antihypertensives,
 diuretics, and electrolytes and replacement
   Know how you maintain your inventory and
 how drugs are replaced,

Emergency Equipment 204

Equipment and supplies commonly used
in life-saving procedures, includes;
   Airways, endotracheal tubes, ambu
   bag/valve/mask, oxygen, tourniquets,
   immobilization devices, nasogastric
   tubes, splints, IV therapy supplies,
   suction machine, defibrillator, cardiac
   monitor, chest tubes, and indwelling
   urinary catheters.


Emergency Equipment 204
 Make sure staff know where the
 equipment is located,
 Know how supplies are replaced and
 who is responsible for doing this,
 Will examine sterilized equipment for
 expiration dates,
 Will check for equipment maintenance
 schedule (defibrillator)
Blood and Blood Products 205

 Need services for the procurement,
 safekeeping, and transfusion of blood,
 including the availability of blood products
 needed for emergencies on a 24-hours a
 day basis ,
 No requirement to store blood on site,
 Can provide in emergency directly or
 through arrangement,
 Some cases more practical to transport
 patient to where the blood is,

Blood and Blood Products
 If CAH does tests on blood will be surveyed
 under CLIA if tests are done,
 If collecting blood you must register with the
 If only storing blood for transfusion and refers
 all tests to outside lab then not performing test
 as defined by CLIA,
 Need agreement in writing regarding the
 provision of blood between CAH and testing
Blood and Blood Products
 Blood must be appropriately stored to
 prevent deterioration,
 If types and cross matches must have
 necessary equipment such as serofuse and
 heat block,
 Or can keep 4 units O Neg on hand at all
 Release to give, signed by doctor, is
 needed since not cross matched.


Blood Storage 206
 Must be under the control and
 supervision of a pathologist or
 other qualified doctor,
 If blood banking done under
 arrangement, the arrangement
 has to be approved by MS and
 Will look for agreement,

Staffing Personnel 207
 Practitioner with training in emergency care
 on call and available within 30 minutes,
 60 minutes if CAH in frontier area (with less than
 6 residents per sq. mile and area meets criteria
 for remote by the state and CMS) and state
 determines longer time than 30 minutes needed is
 only way to provide care,
 Will review call schedules,
 Will ask staff if they know who is on call,


Staffing Personnel 207
  Will review documentation that PA, NP, or MD
  was on site within this time frame,
  RN will satisfy this if for temporary period and
  CAH has less than 10 beds and is in frontier area
  (state governor has to sent letter to CMS as part
  of rural health plan),
  CAH must submit this letter to surveyor and
  demonstrate shortage and unable to provide,
  Also if state law has more stringent staffing
  requirements, like MD on duty 24 hours, must
Coordination with EMS
  Must coordinate with EMS,
  Have a procedure where available by
  phone or radio on 24 hour basis to receive
  Should have policies and procedure in
  place to ensure MD/DO is available by
  And when emergency instructions are


Available Beds 211
  Between 1998 and 2003 had to comply with
  limit of 15 beds,
  Federal law raised bed limit to 25 on Jan 1,
  No more than 25 acute care beds at any one
  time (don’t include observation beds)
  Any of the 25 beds can be used to provide
  acute or long term care (swing beds) dependent
  on patient need.
  Note: some states had a moratorium on beds or a CON
  which prohibited them from adjusting to the federal rate,
Observations/LOS 211
Previously, could not operate distinct units,
Law changed 1-1-04 to allow CAH to operate
psych or rehab beds of no more than 10 beds
Average basis of 96 hours per patient,
Observations stay is usually not more than 48
hours, unless more strict state limit of 24 hours,
Rewrite your policy on observation beds to meet
this section,
They do not count observation beds in 25 bed
count now or in calculating average LOS,
Make sure you are using appropriately,

Observations 211
 Inappropriate use of observation beds
 subjects Medicare beneficiary to increased
 coinsurance liability(20% of CAH customary
 charges) then if properly admitted as
 Observation is not appropriate for :
   Substitute for inpatient admission
   For continuous monitoring
   Medically stable patients who need diagnostic
   testing or outpatient procedure (blood chemo,
Observation Not Appropriate
 Patients awaiting nursing home placement
 For convenience to the patient or family
 For routine prep or recovery prior to or after
 diagnostic or surgical services
 As a routine stop between the ED and
 inpatient admission
 No prescheduled observations services
 Observation services begin and end with the
 order of the physician

Observation 211
 Must provide documentation to show that
 observation bed is not an inpatient bed
 Need specific criteria for observation
 Must be different than inpatient criteria
 10 bed observation unit might be
 disproportionately large
 Surveyor might determine observation is
 actually inpatient overflow unit
Don’t Count in 25 Bed Count 211
 Exam or procedure tables
 OR tables and PACU bed
 Newborn bassinets and isolettes for well baby
 OB beds if active labor but do count birthing rooms
 where patient stays after giving birth
 ED carts
 10 bed distinct rehab or behavioral health unit


Beds/ LOS Hospice 211

 Hospice beds can be dedicated are also
 counted as part of the 25 beds,
 Except 96 hour average LOS rule does
 not apply,
 Medicare does not reimburse the CAH for
 hospice patients only the Hospice,
 So the CAH has to negotiate payment
 from the hospice through an agreement,

Length of Stay 212
 That does not exceed, on an annual average
 basis, 96 hours per patient,
 State Fiscal Intermediary (FI) will determine
 compliance with this CoP,
  Calculate the CAH’S length of stay based on
 patient census data,
  If CAH exceeds the length of stay limit, the FI
 will send a report to the CMS-RO as well as a
 copy of the report to the SA,
 CAH will have to do plan of correction,


Physical Environment 220
  Dept responsible for building and dept must be
 incorporated into hospital QA process.
  Applies to all campuses, satellites, inpatient and
 outpatient locations,
  Is there adequate space for providing direct patient
  Will tour to make sure space to ensure patient
  Will look at housekeeping and preventive
 maintenance programs,
  Evaluate to be sure trash is disposed of properly
 and promptly,
Physical Environment
 Must have housekeeping and preventative
 maintenance programs,
 All essential mechanical, electrical, and patient-
 care equipment is maintained in safe operating
 These means facilities, supplies and equipment
 must be maintained,
 How do you ensure your equipment is maintained
 properly (boilers, elevators, air compressors,
 ventilators, X-ray equipment, IV pumps),
 Will look at walls, ceilings, and floors, maintenance log,

Disposal of Trash                223

 There is proper routine storage and prompt
 disposal of trash,
 Includes biohazardous waste,
 Must be disposed of in accordance with
 standards (EPA, OSHA, CDC,
 environmental and safety),
 Includes radioactive materials,
 Will look for policies for proper storage and
Storage of Drugs          C-224

 Drugs and biologicals must be
 appropriately stored ,
 Must be properly locked in the
 storage area,
 Surveyor will ask what standards,
 guidelines, or law you using to make
 sure they are stored,


Physical Environment 225
 Premises clean and orderly and uncluttered
 with equipment not stored in corridors, spills
 not left unattended, no peeling paint et al.,
 Proper ventilation, lighting, and temperature
 control (226),
 Proper ventilation in areas with nitrous oxide,
 glutaraldehyde, xylene, pentamidine, or other
 potentially hazardous substances,
 Isolation rooms comply with laws-OSHA,
 CDC, NIH, et al,
Physical Environment 226
 Adequate lighting in patient care, food, and
 medication preparation areas,
 Temperature, humidity and airflow in the operating
 rooms must be maintained within acceptable
 standards to inhibit bacterial growth and prevent
 Excessive humidity in the operating room is
 conducive to bacterial growth and compromises
 the integrity of wrapped sterile instruments and
 Acceptable standards such as from AORN or the
 American Institute of Architects (AIA) should be
 incorporated into CAH policy.

Physical Environment
 Must have adequate number of
 refrigerators to make sure foods and meds
 are stored,
 Surveyor will verify these areas are well lit,
 Surveyor will verify compliance with
 ventilation in patients with TB or other
 airborne diseases,
 Surveyor will verify food products are
 stored under appropriate conditions (time,
 temperature, packaging) based on national
 sources like USDA and FDA,
Emergency Procedures 227

  Assure safety of patients in non-
  medical emergencies,
  Staff trained in handling emergencies
  such as reporting and extinguishing
  of fires evacuations, et al.,
  Report all fires to the state officials,
  Will interview staff to make sure they
  know what to do in case of a fire,


Physical Environment

  How do you ensure all personnel are
 trained to manage non medical
  Ask staff what to do in case of a
 tornado, hurricane, earthquake, or
  Review staff training documents and
 in-service records to confirm training,
Physical Environment 228
 Provide for emergency power and lighting in
 ED and for battery lamps or flashlights in
 other areas,
 Must comply with the applicable provisions
 of the Life Safety Code,
 National Fire Protection Amendments
 (NFPA) 101, 2000 Edition and applicable
 references such as NFPA-99: Health Care
 Facilities, for emergency lighting and
 emergency power,


Emergency Fuel and Water 229
 Provide for emergency fuel and water supply
 (snow bound or flooding),
 Must have system to provide emergency gas and
 water as needed to provide care to inpatients and
 other persons who may come to the CAH in need
 of care,
 Includes making arrangements with local utility
 companies and others for the provision of
 emergency sources of water and gas,
 Source of water is FEMA,
 Have a plan for prioritizing their use until
 adequate supplies are available,

Emergency Preparedness Plan
 Develop a comprehensive plan to ensure that the
 safety and well being of patients are assured
 during emergency situations,
  Coordinate with Federal, State, and local
 emergency preparedness and health authorities to
 identify likely risks for their area (e.g., natural
 disasters, bioterrorism threats, disruption of utilities
 such as water, sewer, electrical communications,
 fuel; nuclear accidents, industrial accidents, and
 other likely mass casualties, etc.)
 Develop appropriate responses that will ensure the
 safety and well being of patients.

Emergency Preparedness Plan
The following issues should be considered
when developing the comprehensive
emergency plans:
  Differences needed for each location where
  the certified CAH operates;
   Special needs of patient populations
treated at the CAH (e.g., patients with
psychiatric diagnosis, patients on special
diets, newborns, etc.);
   Security of patients and walk-in patients;
   Security of supplies from misappropriation;
Emergency Preparedness Plan
 Pharmaceuticals, food, other supplies and
 equipment that may be needed during
 emergency/disaster situations;
 Communication to external entities if
 telephones and computers are not
 operating or become overloaded (e.g., ham
 radio operators, community officials, other
 healthcare facilities if transfer of patients is
 necessary, etc.);
 Communication among staff within the CAH

Emergency Preparedness Plan

  Qualifications and training needed by personnel,
  including healthcare staff, security staff, and
  maintenance staff, to implement and carry out
  emergency procedures;
  Identification, availability and notification of
  personnel that are needed to implement and carry
  out the CAH’S emergency plans;
  Identification of community resources, including
  lines of communication and names and contact
  information for community emergency
  preparedness coordinators and responders;

Emergency Preparedness Plan

  Provisions for gas, water, electricity
  supply if access is shut off to the
  Transfer or discharge of patients to home
  or other healthcare settings,
  Methods to evaluate repairs needed and
  to secure various likely materials and
  supplies to effectuate repairs.


Life Safety from Fire 231
 Meet 2000 life safety code of the National
 Fire Protection Association,
 Will survey the building unless 2 hour
 firewall separating the space from
 remainder of building,
 A 2 hour floor slab does not count-must be
 a vertical firewall to constitute a separate
 building or part of a building,
 CMS may delegate older editions of LSC if
 state allows and approved by CMS (232),
LSC Waivers      233

  CMS occasionally will give a waiver,
  Done if LSC rigidly applied and
  would result in unreasonable
  And would not affect health and
  safety of patients,
  Must be recommended by state
  survey agency,

FIRE Inspections    234

          Maintains written evidence of
          regular inspection and approval
          by State or local fire control
          Surveyor will examine copies of
          inspection and approval reports
          from State and local fire control


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