Transcript CAH COPS 2011 1 of 3 - Arkansas Hospital Association

Critical Access Hospitals (CAH)
What every CAH needs to know about the
Conditions of Participation 2011
Speaker
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
President
5447 Fawnbrook Lane
Dublin, Ohio 43017
614 791-1468
[email protected]
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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,
Hospitals accredited by Joint
Commission, AOA, or DNV
Healthcare have what is called
deemed status,
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CAH Problematic Standards
Date and time on all orders and entries
Verbal orders
H&Ps
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
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CAH Problematic Standards
Medical record documentation must reflect
the nursing process
Legibility of the medical record
Equipment and supplies used in life saving
procedure
R&S for PPS hospitals but CAH still need to
do something
Infection control issues
What else should we add???
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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
www.aha.org/aha/key_issues/rural/focus/cah.ht
ml
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CMS Regional Offices
http://www.cms.gov/RegionalOffices/
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www.aha.org/aha_app/issues/CAH/index.jsp
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www.aha.org/aha_app/issues/Rural-Health-Care/index.jsp
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www.flexmonitoring.org/
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CMS CAH Website
CMH has a website for resources
Includes:
 State operations manual, Chapter 2
 Guidance for laws and regulations for
CAH
 Survey and certification general
enforcement information
 Other helpful information
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CMS CAH Website
www.cms.gov/CertificationandComplianc/04_CAHs.asp
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CAH State Operations Manual
Chapter 2- the certification process,
Manual amended 10-16-09,
452 pages long, CAH starts page 274,
www.cms.hhs.gov/manuals/downloads/so
m107c02.pdf
Change of ownership, voluntary
termination of program, initial certification
kits, calculation of bed counts, submission
state plan, processing complaints against
CAH, off- campus locations, etc
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Revision to SOM Exhibits
July 10, 2009, CMS issues revisions to the
state operation manual exhibits,
Located at
www.cms.hhs.gov/manuals/downloads/som
107c05.pdf and 79 pages long,
Management of Complaint/Incidences
 Exhibits accessed
athttp://www.cms.hhs.gov/manuals/downlo
ads/som107c09_exhibitstoc.pdf
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Critical Access Hospitals
 Only 1 of 6 changes in hospitals CoPs affected
hospitals and that was the Medicare Discharge Appeal
Rights,
 Confusing when CMS says hospitals must do this but
will specifically mention CAH must do…….
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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!
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CAH SOM Chapter 2
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Complaint Process
Manual to help surveyor who goes to
the hospital to do a complaint survey
Born Alive,
EMTALA,
Grievances (no patient rights section in
CAH),
Restraint and seclusion,
Abuse and neglect
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Critical Access Hospitals
 Only 3 of 9 changes in hospitals CoPs affected
hospitals and that was the Medicare Discharge Appeal
Rights, Visitation and the proposed telemedicine and
proposed QIO and SA notification
 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!
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Infection Control
Memo 08-04,
Updated to reflect changing infectious and
communicable disease threats,
Including current knowledge and best
practices,
This is why CAH should still look at this
document,
1
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1 Available at www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp,
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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,
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The Conditions of Participation CoPs
First, published in the Federal Register-42 CFR
Part 482.
Federal Register available at no charge at
www.gpoaccess.gov/fr/index.html
Next, CMS publishes Interpretive Guidelines
and some include survey procedures,
This is an important Web site to keep in your
favorites,
Current CoP issued June 12, 2009
1 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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http://cms.hhs.gov/manuals/Downloads/som107ap_w_cah.pdf
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How to Find Changes
Have one person in your facility who
goes out to this website once a month
and checks for updates.
www.cms.hhs.gov/SurveyCertification
GenInfo/PMSR/list.asp,
You can do a search for time frame
and can add words to search,
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CMS Transmittals
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CMS Survey and Certification Website
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Sample CMS Memo
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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
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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,
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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
section,
Time consuming but will have with compliance,
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CMS Hospital CoPs
Consider doing a gap analysis,
Take each section and on left hand side of
page document how you comply with each
section,
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
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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
November 2010 and visitation 2011,
www.cms.hhs.gov/manuals/downloads/som
107_Appendicestoc.pdf
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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
hospitals,
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
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Changes Since the Current Manual
As previously mentioned, the current manual
was published June 9, 2009
The visitation regulation became effective on
January 19, 2010
 Interpretive guidelines expected out soon
The telemedicine standards are still
proposed but final ones coming out soon
QIO and state agency notice changes are
proposed
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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
Organization
 Currently, only hospital inpatients receive this
information
 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
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Medicare Patients, Complaints and QIO
The proposed rule was published in the
Federal Register on February 2, 2011
 at http://www.gpo.gov/fdsys/pkg/FR-2011-0202/pdf/2011-2275.pdf
 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
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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
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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
interpreter
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
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Specific Requirements
For example an ASC, hospice, CAH
hospitals, etc. would have to do the
following;
 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
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Proposed FR February 2, 2011
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Visitation Law in a Nutshell
 Require all hospitals that
accept Medicare or Medicaid
reimbursement
 To allow adult patients to
designate visitors
 Not legally related by marriage
or blood to the patient
 To be given the same visitation
privileges as an immediate
family member of the patient
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Visitation Rights for All Patients
 CMS issued proposed changes to the CAH and
PPS hospital conditions of participation (CoPs)
 Published in the June 28, 2010 Federal Register (FR)
with comments until August 27, 2010
 Had 7,600 comments but 6,300 were form letters
 CMS publishes the final rule in the November
18, 2010 FR
 Regulation effective January 18, 2011
 Applies to all hospitals that accept Medicare and
Medicaid reimbursement
 This includes all critical access hospitals
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Patient Visitation Right
This rule revises the hospital CoPs to ensure
visitation rights of all patients including same
sex domestic partners
Hospitals are required to have policies and
procedures (P&P) on this
P&P must set forth any clinically necessary
or reasonable restrictions or limitations
Hospitals will have to train all staff
 Hospitals will be required to give a written copy of this right
to all patients in advance of providing treatment
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Final Rule FR Effective January 18, 2011
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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
necessary
 Or reasonable restriction or limitation that the
hospital may need to place on such rights
 And the reasons for the clinical restriction or
limitation
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Final Language Patient Visitation Rights
 A hospital must meet the following 4
requirements:
1. Inform each patient (or support person, where
appropriate) of his or her visitation rights

Including any clinical restriction or limitation on such
rights

When he or she is informed of his or her other rights
under this section (previously mentioned)
 For CAH hospitals the last bullet is absent and it
says to do this in advance of furnishing patient care
 Note CAH do not have a pre-exisiting patient rights
section
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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
designates
 Including, but not limited to, a spouse, a
domestic partner (including a same sex
domestic partner),
 Another family member, or a friend, and his or
her right to withdraw or deny such consent at
any time
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Final Language Patient Visitation Rights
3. Not restrict, limit, or otherwise deny
visitation privileges on the basis of race,
color, national origin, religion, sex, gender
identity, sexual orientation, or disability
4. Ensure that all visitors enjoy full and equal
visitation privileges consistent with patient
preferences
So what does this mean??
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Patient Visitation Rights
 All hospitals would have to inform all patients of
their visitation rights in writing in advance of care
furnished
 This includes the right to decide who may and
may not visit them
 Some hospitals may give a one page sheet to
each patient upon admission
 Hospitals would want to amend their patient rights
statement to include this information
– Example: written patient rights given to patients on
admission and could have also brochure in admission
packet
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Patient Visitation Rights
Competent patients can verbally give this
information on admission
 There is no requirement that this has to be in
writing if a competent patient gives oral
confirmation as to who he or she would like to
visit
 Some patients may sign a written patient
visitation advance directive
Some patients may add a section to their
advance directive adding a section on who
they would like to visit or deny visitation
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Patient Visitation Rights
CMS does suggest that this be documented
in the medical record for future reference
Reading of the Federal Register helps to
provide an understanding of what it means
and how to implement it
Federal Register (FR) summarizes the
comments and publishes a response
CMS will eventually add this to the hospital
CMS interpretive guidelines
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Telemedicine Rule in a Nut Shell
 The proposed rule would revise the hospital
CoP
 For both PPS and CAH Hospitals
 Would allow hospital to rely on information
provided from another location 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 TJC accredited Medicare hospital (not
just another TJC accredited facility)
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CMS Proposes Changes in the Federal Register
 So CMS is now proposing less burdensome
telemedicine credentialing rules
 Would allow hospitals to rely on information
provided from another location to base C&P
decisions regarding physicians and practitioners
who use telemedicine at their facility
 CMS realizes that credentialing process is difficult
for small hospitals that lack resources to conduct
traditional credentialing for physicians that provide
telemedicine services
Would need to amend MS by-laws
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CMS Proposes Changes
 The new rule would still allow hospitals to use a
third party credentialing verification organization to
compile and verify the credentials of practitioners
applying for privileges
 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
 Comment period ends July 26, 2010

Source: Federal Register May 26, 2010 http://www.access.gpo.gov/su_docs/fedreg/a100526c.html
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CMS Telemedicine Privileges Rules
 Hospital A has large group of radiologist who want
to provide teleradiology services to Hospital B, a
small community hospital
 Hospital A must and does participate in Medicare
(can’t rely on information from non-hospital
entities)
 The practitioners has privileges at Hospital A and
they give Hospital B a list of the practitioners
privileges from Hospital A
 Each practitioner must hold a state license in the state of
the originating site (Hospital A) and licensed by or
recognized by the state whose patients are receiving the
service
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CMS Telemedicine Privileges Rules
Hospital A reviews the practitioners
performance and sends Hospital B the
results to be used in the periodic
performance review (PPR) of the
practitioners/radiologists
 This information must include any adverse events that
result from the telemedicine services and complaints
 Hospital A is required to evaluate the quality and
appropriateness of the diagnosis and treatment furnished
by its own staff to a CAH hospital
 Board is to ensure there is this agreement and that the
agreement says distant hospital (A) is meeting these
requirements
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CMS Telemedicine Privileges Rules
 Hospital A and B need an agreement between
them and this must state that Hospital A (the distant
or remote hospital) has to conduct credentialing of
telemedicine in accordance with CoPs
 No distinction made between teleradiology and
teleinterpretive service
 Board (Hospital B) will grant privileges according to
the MS recommendations which can rely on the
information from Hospital A now (now an option or
can continue traditional method)
 CMS has regulations in both Board and MS
sections
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CMS Telemedicine Privileges Rules
 Agreement between the two hospitals must state
that the board of the distant site (big hospital)
providing the telemedicine services will meet the
CMS C&P requirements
 This fulfills the originating hospital’s (CAH or small
hospital) board responsibility for its medical staff
that all the requirements are met
 So they can rely on this information and grant
privileges to the radiologists and other physicians
in the telemedicine process
 Can still traditional C&P if you want (but why
would you?)
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Condition Level Requirement Noncompliance
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Deficiency
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 facility’s
capacity to furnish adequate care- no
jeopardy or adverse effect to health or safety
of patient,
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Introduction
 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
needed,

Can get all CFR now electronically off Internet free at GPO access at
www.gpoaccess.gov

Click on Code of Federal Regulations and can do search or click on e-CFR, or
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl,
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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
departments).
Survey protocol and module,
Q- Immediate jeopardy.
V-EMTALA,
T-Hospital swing beds-if you have these,
Hospital/CAH database worksheet Exhibit 286,
Letter of authorization, Ext. 287, to get last
accreditation survey,
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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
guidelines!
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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,
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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 QAPI),
Dietary and cleanliness of dietary,
EMTALA (updated May 29, 2009)
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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,
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Survey Protocol
Survey done thru observation, interviews, and
document review,
Monday-Friday but can come
weekends/evenings,
Do not refuse access or you will be excluded
from getting any money for Medicare/Medicaid
patients (authority is at 42 CFR Part 488 Subpart
A),
Federal law allows CMS or department of health
surveyors access to your facility,
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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
experience,
Team based on complexity of services
offered,
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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
results),
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
hospital),
Previous surveys and findings such as any
deficiencies,
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Task 2-Entrance Activities
Explain survey process to hospital,
Team should enter together,
Usually goes to administration, present their
identification
Explain purpose and scope of survey,
ENTRANCE CONFERENCE-sets tone for entire
survey,
Give surveyors conference room, telephone,
Give names of department heads, their location
and phone numbers,
Organizational chart,
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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,
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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,
doctors,
Give preliminary date and time for exit conference,
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Task 2-Entrance Activities
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,
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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
locations,
Observe actual care, Provide copies of materials,
Use interpretive guidelines to guide survey,
Use Appendix Q if Immediate Jeopardy is
suspected,
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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
immediately,
Surveyors must respect patient privacy and
confidentiality,
However, work with surveyor so they do not
take peer protected documents with them,
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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
equipment,
 Observe storage and security of medical
records,
 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,
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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,
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Task 4 Preliminary Decision
Preliminary Decision Making and Analysis of
Findings
Review and analyze all information gathered,
Determine if CoPs are met (42 CFR Part
485),
 Prepare exit conference report,
If noncompliance with CoP then determine if at
standard or condition level and how dangerous it
is,
All noncompliance must be cited even if
corrected on site,
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Deficiency
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,
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Task 5- Exit Conference
Objective is to inform facility of preliminary
findings,
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
one,
Official findings are provided in writing on Form
CMS 2567,
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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,
88
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
database,
Certification of providers with deficiencies if
acceptable plan of correction,
Failure to submit acceptable plan of correction can
result in termination of provider agreement
89
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 swingbed requirements found at 42 CFR Part
485.645,
Reimbursement is for Skilled Nursing care as
opposed to Acute Care,
 Term is for reimbursement and has no
relationship to geographic location in the
hospital,
.
90
Swing Bed Module
May be in acute care status one day and then
in swing bed status the next day,
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 Part 483
91
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
years.
92
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
(210),
 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
patients,
 Swing bed deficiencies are documented on a
separate form even though survey done
simultaneously,
93
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
guidelines”,
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,
94
Compliance with Laws C-150
The CA hospital 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 issues),
95
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,
96
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,
97
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,
98
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 colocation 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
99
Off-Campus and Co-Location 167
However, some CAH were designated by
the state as necessary providers before 1-106
This made them exempt from the 35 mile
rule
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
agreements
100
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
arrangement
101
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
Will ask how CAH communicates with other
hospitals- do you keep a communication
log?
What P&P related to communication
system?
Will review any written agreements with
local EMS
102
Working with the Other Hospital
Patient referrals and transfers (192),
Need to provide for transport between
the two facilities
Do the two hospitals have electronic
sharing of patient data, telemetry and
medical records (193)
103
Credentialing and QA Agreement 195
 Each CAH has to have an agreement with either a
hospital in rural health network, or QIO, or entity
identified in state rural health care plan,
 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,
104
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
location,
Must comply with acceptable standards of
practice,
Including those established by national
professional organizations such as ACEP, ENA,
ACS, ANA, AMA, American Association for
Respiratory Care,
105
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
activities,
MS must establish qualifications to get
privileges to provide ED care,
ED must be adequately staffed,
Must have adequate equipment,
106
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.),
107
14 ED Policies (Respiratory)
P&P must be developed approved by MS,
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,
108
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 services.
109
ED Staff Training (continued)
• Equipment assembly and operation;
• Safety practices, including infection control
measures;
• 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;
110
ED Staff Training (continued)
• Therapeutic percussion and vibration;
• Bronchopulmonary drainage;
• Mechanical ventilatory and oxygenation
support;
• Aerosol, humidification, and therapeutic gas
administration;
• Administration of medications; and
• Procedures for obtaining and analyzing
ABGs.
111
EMTALA and ED 24 hours
Must still meet EMTALA (anti-dumping)
requirements,
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
minutes,
112
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
practice,
Surveyor will ask how you make sure
equipment, supplies, and medications are
always available,
113
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
solutions.
Know how you maintain your inventory and
how drugs are replaced,
114
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.
115
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)
116
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,
117
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
FDA,
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
lab,
118
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
times,
Release to give, signed by doctor, is
needed since not cross matched.
119
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
administration,
Will look for agreement,
120
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,
121
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
follow,
122
Coordination with EMS
 Must coordinate with EMS,
 Have a procedure where available by
phone or radio on 24 hour basis to receive
calls,
 Should have policies and procedure in
place to ensure MD/DO is available by
phone,
 And when emergency instructions are
needed,
123
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,
2004,
 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,
124
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
each,
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,
125
Observations 211
Inappropriate use of observation beds
subjects Medicare beneficiary to increased
coinsurance liability(20% of CAH customary
charges) then if properly admitted as
inpatient,
Observation is not appropriate for :
 Substitute for inpatient admission
 For continuous monitoring
 Medically stable patients who need diagnostic
testing or outpatient procedure (blood chemo,
dialysis)
126
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
127
Observation 211
Must provide documentation to show that
observation bed is not an inpatient bed
Need specific criteria for observation
services
Must be different than inpatient criteria
10 bed observation unit might be
disproportionately large
Surveyor might determine observation is
actually inpatient overflow unit
128
Don’t Count in 25 Bed Count 211
 Exam or procedure tables
 Stretchers
 OR tables and PACU bed
 Newborn bassinets and isolettes for well baby
boarders
 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
129
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,
130
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,
131
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
care?,
Will tour to make sure space to ensure patient
safety,
Will look at housekeeping and preventive
maintenance programs,
Evaluate to be sure trash is disposed of properly
and promptly,
132
Physical Environment
Must have housekeeping and preventative
maintenance programs,
All essential mechanical, electrical, and patientcare equipment is maintained in safe operating
condition
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,
133
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
disposal,
134
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,
135
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,
guteraldehydes, xylene, pentamidine, or other
potentially hazardous substances,
 Isolation rooms comply with laws-OSHA, CDC,
NIH, et al,
136
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
infection,
 Excessive humidity in the operating room is
conducive to bacterial growth and compromises
the integrity of wrapped sterile instruments and
supplies,
 Acceptable standards such as from AORN or the
American Institute of Architects (AIA) should be
incorporated into CAH policy.
137
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,
138
Emergency Procedures 227
Assure safety of patients in nonmedical 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,
139
Physical Environment
How do you ensure all personnel are
trained to manage non medical
emergencies?
Ask staff what to do in case of a
tornado, hurricane, earthquake, or
blizzard,
Review staff training documents and
in-service records to confirm training,
140
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,
141
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,
142
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.
143
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;
144
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
itself;
145
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;
146
Emergency Preparedness Plan
Provisions for gas, water, electricity
supply if access is shut off to the
community;
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.
147
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),
148
LSC Waivers
233
CMS occasionally will give a waiver,
Done if LSC rigidly applied and
would result in unreasonable
hardship,
And would not affect health and
safety of patients,
Must be recommended by state
survey agency,
149
FIRE Inspections
234
Maintains written evidence of
regular inspection and approval
by State or local fire control
agencies,
Surveyor will examine copies of
inspection and approval reports
from State and local fire control
agencies,
150
The End Questions???
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
President
5447 Fawnbrook Lane
Dublin, Ohio 43017
614 791-1468
[email protected]
151
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The END
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