Transcript CAHCOPS2014 - Arkansas Hospital Association

Critical Access Hospitals (CAH)
What every CAH needs to know about the
Conditions of Participation (CoPs)
Speaker
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
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You Don’t Want One of These
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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 or
Medicaid patients,
Hospitals accredited by the
Joint Commission (TJC), AOA,
CIHQ, 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, Cluttered hallways
H&Ps, Life safety code issues, EMTALA,
Informed consent, Cleanliness of dietary
Plan of care, Privacy and whiteboard,
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, Timing of medications
Legibility of the medical record, No orders
Equipment and supplies used in life saving
procedure, Hand Hygiene & Gloving
R&S for PPS hospitals but CAH still need to
do something, Failure to Monitor Patient for
Safety (Suicide Precautions)
Infection control issues are big
What else should we add???
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Access to Hospital Complaint Data
CMS issued Survey and Certification memo
on March 22, 2013 regarding access to
hospital complaint data
Includes acute care and CAH hospitals
 Does not include the plan of correction but can request
 Questions to [email protected]
This is the CMS 2567 deficiency data and
lists the tag numbers
Will update quarterly
 Available under downloads on the hospital website at www.cms.gov
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Access to Hospital Complaint Data
There is a list that includes the hospital’s
name and the different tag numbers that
were found to be out of compliance
 Many on restraints and seclusion, EMTALA,
infection control, patient rights including
consent, advance directives and grievances
Two websites by private entities also publish
the CMS nursing home survey data
 The ProPublica website for LTC
 The Association for Health Care Journalist (AHCJ)
websites for hospitals
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Access to Hospital Complaint Data
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Updated Deficiency Data Reports
www.cms.gov/Medicare/Provider-Enrollment-andCertification/CertificationandComplianc/Hospitals.html
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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 http://www.aha.org/aha/issues/RuralHealth-Care/update-newsletters.html
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AHA CAH Resources
www.aha.org/aha/issues/RuralHealth-Care/updatenewsletters.html
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AHA CAH Resources
www.aha.org/advocacyissues/rural/updatenewsletters.shtml
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CMS Updated Website www.cms.gov
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AHA Critical Access Website
www.aha.org/aha_app/issues/CAH/index.jsp
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Rural Assistance Center
www.raconline.org
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Rural Assistance Center
www.raconline.org
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CMS CAH Website
CMS has a website for resources
Includes:
 State operations manuals
 Program transmittals
 Guidance for laws and regulations for
CAH
 Medicare Learning network
 Other helpful information
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CMS CAH Website
ww.cms.gov/center/cah.asp
http://www.cms.gov/Center/ProviderType/Critical-Access-HospitalsCenter.html?redirect=/center/cah.asp
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Critical Access Hospitals
 Confusing when CMS says hospitals must do this but
will specifically mention CAH must do…
 Changes affecting CAH hospitals included Medicare
Discharge Appeal Rights, Visitation and the
Telemedicine
 Verbal order Tag Number 297,H&P 320,
 IV Medication and blood memo changed June 7, 2013

Informed consent 304 and 320,
 Security of Medications 276,
 Anesthesia assessments 321,
 Infection control 278 but you should still look at these!
 Privacy and confidentiality but you should look at these also!
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The Conditions of Participation CoPs
First, published in the Federal Register
Federal Register available at no charge at
www.gpoaccess.gov/fr/index.html
Next, CMS publishes Interpretive Guidelines
and some include survey procedures,
Current CoP issued January 31, 2014
Changes to tag 162 and 226
CMS made many changes effective June 7,
2013
1 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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Subscribe to the Federal Register Free
http://listserv.access.gp
o.gov/cgibin/wa.exe?SUBED1=
FEDREGTOC-L&A=1
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new website at
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
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www.cms.gov/manuals/Downloads/som107ap_w_cah.pdf
and is critical access hospital CoPf
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CAH Manual 232 Pages
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CAH Services Direct Services or Contracts
CMS published more than 2 dozens changes
to the hospital CoP in FR on May 16, 2012
and went into effect June 7, 2013
Several that impact CAHs
Currently. The CAH CoP requires that certain
types of services be provided directly rather
than through contracts or under arrangements
 This included diagnostic and therapeutic
services, lab and radiology services, and
emergency procedures
 CMS eliminated this requirement
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CMS Final Changes Memo www.empsf.org
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Feb 4, 2013 Proposed Changes
CMS issues 114 pages related to proposed
changes to the CMS CoP
 Hospital privileges for RD to write diet orders
 Board must consult with chief medical officer for
each individual hospital rea quality of medical care
provided in the hospital
 Confirmed each hospital must have separate
medical staff
 MS can include PharmD, dieticians, PA, NP, etc.
 No requirement for board to include MD/DO
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Feb 4, 2013 Proposed Changes
 Allow practitioners not on MS to order outpatient
services
 Allow in-house preparation of radiopharmaceuticals
on off hours without a physician or a pharmacist
being present
 3 changes for hospitals that are transplant centers
 ASC change for radiology services incident to the surgery
Swing beds move to Part D so accreditation
organizations can survey
 CAH P&P committee deleted requirement for non staff
member requirement
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Feb 4, 2013 Proposed Changes
www.ofr.gov/inspection.aspx
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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/SurveyCertificationGenI
nfo/PMSR/list.asp,
You can do a search for time frame and
can add words to search,
 Click on fiscal year to bring up most current memos
CMS issues transmittal before putting it
into the CAH Manual
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CMS Survey and Certification Website
www.cms.gov/SurveyCertific
ationGenInfo/PMSR/list.asp#
TopOfPage
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CMS Transmittals
www.cms.gov/Transmittals/01_overview.asp
http
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CMS Memo on Safe Injection Practices
CMS issues a 7 page memo on safe injection
practices
Discusses the safe use of single dose
medication to prevent healthcare associated
infections (HAI)
Notes exception which is important especially
in medications shortages
 General rule is that single dose vial (SDV)can only be used
on one patient
 Will allow SDV to be used on multiple patients if prepared by
pharmacist under laminar hood following USP 797 guidelines
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Safe Injection Practices
http://www.cms.gov/Medicare/ProviderEnrollment-andCertification/SurveyCertificationGenInfo/index.ht
ml?redirect=/SurveyCertificationGenInfo/PMSR/li
st.asp
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CMS Memo on Safe Injection Practices
 All entries into a SDV for purposes of repackaging
must be completed with 6 hours of the initial
puncture in pharmacy following USP guidelines
 Only exception of when SDV can be used on
multiple patients
 Otherwise using a single dose vial on multiple
patients is a violation of CDC standards
 CMS will cite hospital under the hospital CoP
infection control standards since must provide
sanitary environment
 Also includes ASCs, hospice, LTC, home health, CAH, dialysis, etc.
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CMS Memo on Safe Injection Practices
 Bottom line is you can not use a single dose vial
on multiple patients
 CMS has section in IC worksheet on this
 CMS requires hospitals to follow nationally
recognized standards of care like the CDC
guidelines
 SDV typically lack an antimicrobial preservative
 Once the vial is entered the contents can support
the growth of microorganisms
 The vials must have a beyond use date (BUD)
and storage conditions on the label
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CMS Memo on Safe Injection Practices
 Make sure pharmacist has a copy of this memo
 If medication is repackaged under an arrangement
with an off site vendor or compounding facility ask
for evidence they have adhered to 797 standards
 ASHP Foundation has a tool for assessing
contractors who provide sterile products
Go to
www.ashpfoundation.org/MainMenuCategories/Practic
eTools/SterileProductsTool.aspx
 Click on starting using sterile products outsourcing tool
now
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Not All Vials Are Created Equal
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CMS Memo on Insulin Pens
CMS issues memo on insulin pens
Insulin pens are intended to be used on one
patient only
 CMS notes that some healthcare providers are
not aware of this
 Insulin pens were used on more than one
patient which is like sharing needles
 Every patient must have their own insulin pen
 Insulin pens must be marked with the patient’s
name
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CMS Memo on Insulin Pens
Regurgitation of blood into the insulin
cartridge after injection can occur creating a
risk if used on more than one patient
Hospital needs to have a policy and
procedure
Staff should be educated regarding the safe
use of insulin pens
More than 2,000 patients were notified in
2011 because an insulin pen was used on
more than one patient
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CDC issues reminder on same and has free
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/insulinpens.html
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CDC Has Flier for Hospitals on Insulin Pens
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VA Alert on Insulin Pens
Pharmacist found several insulin pens not
labeled for individual use
Found used multi-dose pen injectors used on
multiple patients instead of one patient use
New requirement that can only be stored in
pharmacy and never ward stocked
Instituted new education for staff on use
Part of annual competency of staff
Instituted new policy of safe use of pen
injectors
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VA Issues Alert
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VA Alert on Insulin Pens
Decided to prohibit multi-dose insulin pen
injectors on all patient units except the
following:
 Patients being educated prior to discharge to use a
insulin pen injector
 Eligible patient is self medication program
 Patient needing treatment and no alternative
formulation is available
 Patients participating in a research protocol requiring
an insulin pen
 Pen injectors dispensed directly to patients as an
outpatient prescription
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FDA Issues An Alert in 2009
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Insulin Pen Posters and Brochures Available
www.oneandonlycampaign.org
/content/insulin-pen-safety
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Pt Safety Briefs Free at www.empsf.org
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Luer Misconnections Memo
 CMS issues memo March 8, 2013
 This has been a patient safety issues for many
years
 Staff can connect two things together that do
not belong together because the ends match
 For example, a patient had the blood pressure
cuff connected to the IV and died of an air
embolism
 Luer connections easily link many medical
components, accessories and delivery devices
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Luer Misconnections Memo
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PA Patient Safety Authority Article
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June 2010 Pa Patient Safety Authority
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ISMP Tubing Misconnections
www.ismp.org
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TJC Sentinel Event Alert #36
www,jointcommission.org
http://www.jointcommission.org/sentine
l_event_alert_issue_36_tubing_misco
nnections—
a_persistent_and_potentially_deadly_
occurrence/
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CMS Hospital Worksheets Third Revision
 October 14, 2011 CMS issues a 137 page memo in the
survey and certification section
 It was pilot tested in hospitals in 11 states and on May
18, 2012 CMS published a second revised edition
 Piloted test each of the 3 in every state over summer 2012
 November 9, 2012 CMS issued the third revised
worksheet which is now 88 pages
 Memo discusses surveyor worksheets for
hospitals by CMS during a hospital survey
 Addresses discharge planning, infection control,
and QAPI (performance improvement)
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CMS Hospital Worksheets
 This is the third and final pilot and in 2014 will be
revised
 Will use whenever a validation survey or
certification survey is done at a hospital by CMS for
PPS hospitals
 Not currently being used for CAH
However, highly suggest that every CAH
review and be aware of what is in these three
forms
 Helps to understand how the guidelines are
interpreted
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Third Revised Worksheets
www.cms.gov/SurveyCertificationGe
nInfo/PMSR/list.asp#TopOfPage
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CMS Hospital CoPs
Appendix W, Tag C-0150 to C 0408,
See visitation memo adding tag10001002 which is after tag 298
Interpretive guidelines updated more
frequently now
About 232 pages long,
Manual includes swing beds in CAHs,
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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 can have up to a ten
bed rehab or psych (behavioral health)
unit
If so it is surveyed under the regular
hospital CoP program even though
CAH has a separate manual
It is Appendix A
Last updated January 31, 2014
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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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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,
W-Hospital swing beds-if you have these,
B- Home health
I-Life safety code
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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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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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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,
.
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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 swingbed status,
Actual swing-bed survey requirements
are referenced in the Medicare Nursing
Homes requirements at 42 CFR Pt 483
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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,
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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)
Then the 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,
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Compliance with Laws C-150
Standard: The CAH must be in
compliance with all federal, state, and
local laws,
Surveyor may interview CEO or other
designated by hospital to determine this,
May refer non-compliance to proper agency
with jurisdiction such as OSHA
 TB, blood borne pathogen, universal
precautions, or EPA (haz mat or waste
issues),
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Advance Directives 151 2013
Standard: CAH must be in compliance with
federal laws and regulations related to the
health and safety of patients
Inpatients and outpatients have the right to
make advance directives
Staff must comply with their advance
directives
Patients have the right to refuse treatment
Make have a DPOA or another person such
as a support person/patient advocate
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Advance Directives 151
May use advance directives to designate a
support person for a person of exercising the
visitation rights
If patient incapacitated and DPOA then must
give this information to make informed
decisions and consent for the patient
CAH must also seek the consent of the
patient’s representative when informed
consent is required for a care decision
 Surrogate decision makers step into shoe of
patient when incompetent
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Advance Directives 151
Must provide advance directive information
to the competent patient when admitted
 Must also give to the outpatient if in the ED,
observation, or same day surgery patient
 Must document you gave it in the medical
record
If incapacitated then to the family or
surrogate
Has conscience objector clause but must still
allow DPOA or support person to make
decision if incapacitated
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Advance Directives 151
Can not require one
Document in the medical record
Must make sure staff is educated on the
P&P
This includes the right to make a psychiatric
advance directive or mental health
declaration
 Should still give consideration even if not a
state specific law
Must provide community education
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Physician Ownership Disclosures 151
Must disclose if physician owned hospital
 This includes ownership by immediate family member and
must be in writing
 If none of physician owner refer then the hospital must sign
attestation to this effect
 Physicians must also disclose to patients who
they refer
 This must be as a condition for getting MS
privileges
 Disclose in writing if physician not on premise 24
hours a day for emergencies
 Sign acknowledgement if patient admitted
81
Compliance with Laws/Licensure
Standard: Patient care services must be
provided with in accordance with laws (152),
Ensure delegation as allowed by law,
Ensure practicing according to scope of
practice, such as NP, CNS, PA,
Standard: Hospital must be licensed (153)
Personnel must be licensed or certified if
required by state (Tag 154: doctors, nurses, PT,
PA, OT, x-ray tech. et. al.),
Review sample of personnel files to be
credentials and licensure is up to date,
82
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,
83
Status and Location
160-162 2013
CAH must meet the location requirements at
the time of the initial survey (160)
Compliance is reconfirmed at the time of
every subsequent full survey
Tag 162 discusses information regarding if
the CAH has been classified as an urban
hospital
Discusses CAH located outside any area that
is a metropolitan statistical area
CAH must be in a rural area
84
Q&A
85
Location in a Rural Area 8-30-13
86
Agreement with Network Hospitals 191
Standard: 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
transportation
Will ask how CAH communicates with other
hospitals- do you keep a communication log?
87
Working with the Other Hospital
What P&P related to communication
system?
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)
88
Credentialing and QA Agreement 195
Standard: The CAH has to have an
agreement with a hospital that is a member
of the network or QIO for quality
improvement and credentialing
 State networking requirements vary.
 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,
89
Telemedicine Agreements C&P 196
Standard: Agreements for C&P Telemedicine
Physicians
 Board must make sure agreement with distantsite 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 MS
 Board approves the MS bylaws and other MS
rules and regulations
90
Telemedicine December 22, 2011
91
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
judgment
Make sure under no circumstance is
privileges based solely on certification,
fellowship, or membership in a special body
or society
92
Telemedicine C&P
197
93
Emergency Services 200
Standard: 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,
94
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,
95
Emergency Services 200
Must determine the categories and
numbers of staff needed in the ED
 MD/DO, RN, ward clerks, PA, NP, 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 Doppler's, ultrasound et. al.,
96
14 ED Written Policies
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,
97
ED Written Policies
• 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;
98
ED Written Policies
• 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.
99
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.
100
EMTALA and ED 24 hours
Must still meet EMTALA (anti-dumping)
requirements,
Revised July 16, 2010 into 68 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,
101
EMTALA, CAH & Telemedicine Memo
CMS welcomes the use of telemedicine by
CAH
CAH not required to have a doctor to
appear when patient comes to the ED
PA, NP, CNS, or physician with
emergency care experience must show up
within 30 minutes
If MD/DO does not show up must be
immediately available by phone or radio
contact 24 hours a day
102
CMS S&C Memo EMTALA & CAH
103
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,
104
Emergency Drugs 203
Drugs used in life-saving procedures,
includes;
Analgesics, local anesthetics, antibiotics,
anticonvulsants, antidotes and emetics,
serums and toxoids, antiarrythmics, cardiac
glycosides, antihypertensive, diuretics, and
electrolytes and replacement solutions.
Know how you maintain your inventory
and how drugs are replaced,
105
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.
106
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),
107
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,
108
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,
109
Blood and Blood Products
Blood must be appropriately stored to
prevent deterioration,
If types and cross matches must have
necessary equipment
Or can keep 4 units O Neg on hand at
all times,
Release to give, signed by doctor, is
needed if not cross matched when
indicated in an emergency
110
Blood Storage 206
Blood storage 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 an agreement,
111
Staffing Personnel 207
Must have practitioner (physician, PA,
NP) with training in emergency care on
call and immediately 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,
112
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,
 See CMS Memo
113
Coordination with EMS 209
 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 or radio contact,
 And when emergency instructions are
needed,
114
25 Available Beds 211
CAH maintains no more than 25 acute
care beds at any one time
 Doesn’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
Does not count if CAH has up to 10 bed
rehab unit or behavioral health unit
Average basis of 96 hours per patient,
115
Observations/LOS 211
Previously, could not operate distinct units,
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 and the 2 midnight rule,
They do not count observation beds in 25 bed
count now or in calculating average LOS,
Make sure you are using appropriately,
See the CMS memo on the two midnight rule
 Place in an outpatient observation bed
 Admit as an inpatient to telemetry
116
117
Two Midnight Rule
 Need an order and need to document medical
necessity
 For inpatient CAH services only, the physician must
certify that the beneficiary may reasonably be
expected to be discharged or transferred to a
hospital within 96 hours after admission to the
CAH.
 Time as an outpatient at the CAH does not count
towards the 96 hours requirement.
 The clock for the 96 hours only begins once the individual is
admitted to the CAH as an inpatient.
 Time in a CAH swing-bed also does not count towards the 96 hour
inpatient limit.
118
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)
119
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
120
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
121
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 unit rehab or behavioral health
122
Beds/ LOS Hospice 211
Observation starts and ends with order
 No standing orders for observation
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,
123
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,
124
Part 2
125
Construction 6-7-2013
Standard: CAH is constructed, arranged, and
maintained to ensure access to and safety
of patients
Additionally, it must provide adequate space
to provide care to patients
Must be constructed in accordance with state
and federal law
Will look to see if maintained in a manner to
ensure safety of patients
 Conditions of ceilings, walls, and floors
126
Physical Environment 222
Must have housekeeping and preventative
maintenance programs,
All essential mechanical, electrical, and patient-care
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, stretchers, IV
equipment, air compressors, elevators, maintenance log,
127
CMS Hospital Equipment Maintenance
128
Physical Environment
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 (PM) programs,
Evaluate to be sure trash is disposed of properly
and promptly,
129
Disposal of Trash
223
Standard: 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,
130
Storage of Drugs 224
Standard: Drugs and biologicals must
be appropriately stored,
Must be properly locked in the storage area,
 Make sure medication carts in C-section rooms
are locked
 Make sure drugs are not left out in open in tube
system or on dumb waiter ledge
Surveyor will ask what standards,
guidelines, or law you using to make
sure they are stored,
131
Physical Environment 225
 Standard: Premises clean and orderly
 Means uncluttered with equipment not
stored in corridors,
 Area is neat and well kept
 Spills not left unattended,
 No peeling paint or floor obstructions,
 No visible water leaks or plumbing
problems
132
Proper Ventilation 226 1-31-14
 Standard; There must be proper ventilation,
lighting, and temperature controls,
 In pharmaceutical, patient care and food
preparations
 Proper ventilation in areas with nitrous
oxide, glutaraldehyde, xylene, pentamidine,
or other potentially hazardous substances,
 Isolation rooms comply with laws such
CDC 2007 Isolation Guidelines, OSHA,
NIH, et al,
133
Physical Environment 226
 Temperature, humidity and airflow in the operating
rooms must be maintained within acceptable
standards to inhibit bacterial growth and prevent
infection,
 Including anesthetizing locations where inhalation
anesthesia agents are used
 Excessive humidity in the operating room is
conducive to bacterial growth and compromises the
integrity of wrapped sterile instruments and supplies,
 RH at 35% or greater unless waiver is used of 20% or
greater
 Acceptable standards such as from AORN or the
Facilities Guideline Institute or FGI) should be
incorporated into CAH policy.
134
CMS Memo April 19, 2013
 CMS issues memo related to the relative
humidity (RH)
 AORN use to say temperature maintained
between 68-73 degrees and humidity between
30-60% in OR, PACU, cath lab, endoscopy
rooms and instrument processing areas
 CMS says if no state law can write policy or
procedure or process to implement the waiver
 Waiver allows RH between 20-60%
 In anesthetizing locations- see definition in memo
135
Humidity in Anesthetizing Areas
136
Proper Ventilation & Lighting 1-31-14
137
CMS Memo April 19, 2013
CMS issues memo related to the relative
humidity (RH)
AORN use to say temperature maintained
between 68-73 degrees and humidity
between 30-60% in OR, PACU, cath lab,
endoscopy rooms and instrument processing
areas
CMS says if no state law can write policy or
procedure or process to implement the
waiver
138
Waiver allows RH between 20-60%
Physical Environment 226
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,
139
Emergency Procedures 227
Standard: 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,
140
Physical Environment 227
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,
141
Physical Environment 228
Standard: 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,
142
Emergency Fuel and Water 229
Standard: 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 information on water is FEMA,
 Have a plan for prioritizing their use until adequate
supplies are available,
143
Emergency Preparedness Plan 230
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.
144
CMS Revised Checklist Memo
CMS issues 8 page memo on Feb 28, 2014
Regarding checklist for emergency
preparedness (EP)
Update provides information about patient
tracking, supplies and collaboration
Discusses Oct 24, 2007 memo on EP
 This updated checklist can be found at S&C
Emergency Preparedness Website
http://www.cms.hhs.gov/SurveyCertEmergPr
ep
145
CMS Revised Checklist
146
147
Proposed Changes EP Requirements
CMS publishes proposed rule in the Federal
Register on December 27, 2013
Requires hospitals that accepts Medicare or
Medicaid to adequately plan for disasters
Whether natural or man made
Would have to coordinate with federal, state,
and local emergency preparedness systems
To enhance patient safety during an
emergency
148
Proposed Changes EP Requirements
149
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;
150
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;
151
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;
152
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.
153
FIRE Inspections 231-233
Must meet LSC of National Fire Protection
Association such as NFPA-99 (231)
CMS can allow state surveyor to apply
state’s fire and safety code if CMS finds that
it adequately protects patients
CMS can waive specific provisions of the
LSC if it would result in unreasonable
hardship
 But only if the waiver does not put patients at
risk
154
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,
155
Governing Body 241
Standard; CAH has a governing body or
individual that assumes legal responsibility
for implementing and monitoring P&Ps,
Must have 1 governing body or responsible
person,
Board must determine what categories of
practitioners are eligible for appointment and
reappoint to MS (NP, PA, dentist, CRNA) and
there is written criteria for staff appointments,
Done with advice of MS,
156
Governing Body 241
Must be consistent with state and federal law
requirements,
Board approves MS bylaws and any
revisions
 Surveyor will look for this,
Board responsible for conduct of CAH and
for quality of care to patients,
All patients must be under the care of a
member of the MS
 Or under care of member of MS under their
supervision
157
Governing Body
 Criteria for MS is based on individual
character, competence, training,
experience and judgment,
 Surveyor will look to see Board or written
documentation of person responsible for
CAH,
 Will look to verify that Board has categories
of practitioners for appointment to MS,
 Confirm that Board appoints all members
to the MS,
158
Disclosure
242
CAH discloses the names and addresses of
its owners or those with controlling interest,
Either directly or indirectly has 5% or more
ownership,
Surveyor will look for policy on reporting
changes of ownership,
Need policy on how to reporting changes for
person responsible for operation of hospital
(CEO) to state agency and also for reporting
changes in medical director (243,244),
159
Staffing 250
Standard: CAH has professional staff
that includes one or more physicians,
and may include PA, NP, or CNS,
Need to have organizational chart
which shows names of all MD/DO and
mid-level providers
 PA, NP, or CNS
Surveyor will review work schedules,
160
Staffing 252
Standard: All ancillary staff must be
supervised by professional staff,
Have sufficient staff to take care of
patients
 Emergency services, nursing services, Tag 253,
Will review staffing schedules and daily
census records,
 Make sure answer call lights promptly
 Make sure address monitor that alarms timely
161
Staffing 254
MD, DO, NP, PA, or CNS must be
available at all times to furnish care,
Must show practitioner is available
and shows up when patient presents
to the hospital,
Doesn’t mean they have to be there
24 hours a day,
162
Nurse on Duty 255
Standard: Must have a
RN, CNS, or LPN on
duty whenever there is
one or more inpatients,
Surveyor will review
staff schedules to make
sure,
163
Physician Responsibilities 257
Standard: MD/DO must provide medical
directions and supervision of staff,
Surveyor will make sure is available for
consultation and supervision of staff,
Physicians must periodically review charts
of PA and NP and surveyor will look for
documentation of same (259),
MD/DO must provide orders for patients and
must review and sign all MR cared by PA,
NP, or CNS (260),
164
Physician Supervision
Must have a doctor on staff and must
perform medical oversight,
 Must be present for sufficient period of
times or at least once every two week to
provide direction
Will want evidence that the Dr. provides
oversight and is available for consultation or
patient referral,
What evidence the there is periodic review of
patient records by the doctor?
165
PA, NP, CNS 263
Must be members of CAH staff,
Must participate in development and review
of P&P,
Interview them to determine their
participation and knowledge of policies,
Will interview to determine their level of
involvement in development of P&Ps and
make updated,
Policies also need to be consistent with
state standards of practice,
166
Transfer of Patients 267
Standard: Arrange for transfer of
patients who need services that
can not be furnished,
 Must sent the patient’s medical
records,
 Remember EMTALA is a separate
CoP that every CAH must follow,
 Make sure you have a transfer policy
and it should be consistent with
EMTALA,
167
Patient Admission 268
 Standard: Whenever a patient is admitted by
NP, PA, or CNS, a physician on the staff must
be notified,
 CMS requires that Medicare and Medicaid patients
be under the care of a MD/DO if patient has
medical or psych problems that are outside of the
scope of their practice,
 Admitting privileges must be consistent with what
state law allows,
 Surveyor will look to make sure MD/DO monitor
care for any medical problem outside their scope of
practice,
168
Patient Care Policies 271
Standard: Services are provided in
accordance with appropriate P&P,
Will review policies,
Review sampled records,
Observe staff delivering care to the patient,
P&P need to be developed by group of professional
person sand include 1 MD/DO and 1 or more PA,
NP, CNS if on staff and one member is who not a
member of the staff (272),
 Will change section about person not member of the staff
Will interview CNO to determine role in policy
development (272),
169
Policies (Scope of Services) 273 2013
Standard: Need P&P on scope of services
provided by CAH directly or through
agreement,
 Should include statements like “taking complete
medical histories, providing complete physical
examinations, laboratory tests including” (with a list
of tests provided) would satisfy this requirement,
 Should include arrangements made with Hospital X
for providing the following services with list of
specialized diagnostic and lab testing,
170
Emergency Medical Services 274
Need P&P for emergency medical
services,
Policies should show how the CAH
would meet all of its emergency
services requirements,
171
Guideline for Medical Management 275
Guidelines on managing health
problems that include when medical
consultation is needed,
And patient referral (275),
Guidelines on maintaining medical
records and procedure for periodic
review and evaluation of the services
provided at the CAH,
172
Medical Management 275
Needs to include the scope of medical
acts which may be done by PA or NP,
What medical procedures can PA or
NP do?
Guidelines need to describe the
medical conditions, signs or
development that require consultation,
173
Part 2
174
The End! Questions??
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
175
175
Drugs and Biologicals
276
Rules for the storage, handling,
dispensing, and administration of drugs
and biologicals,
Need to store drugs in accordance with
acceptable standards of practice,
Keep accurate records of the receipt
and disposition of all scheduled drugs,
And all outdated, mislabeled, or
otherwise unusable drugs are not
available for patient use,
176
Pharmacy
276
The pharmacy director, with input from
appropriate CAH staff and committees,
develops, implements and periodically
reviews and revises P&P on the provision of
pharmaceutical services,
 Store drugs as required by manufacturer,
 Pharmacy records detailed to follow flow of drugs
from entry to dispensing and administration,
 Employees provide pharmacy services within scope
of license and education,
 Pharmacy must maintain control over all drugs and
medications including floor stock,
177
Dispensing of Drugs 276
Drugs must be dispensed by licensed
pharmacist,
Only pharmacists or pharmacy supervised
personnel compound, label and dispense drugs
or biologicals,
How do you make sure accurate records of receipt
and disposition of scheduled drugs,
Who has access and keys to drug area?
How do you make sure no outdated drugs or
mislabeled drugs?
Will inspect the pharmacy,
178
Pharmacy
276
Pharmaceutical services can be provided
as direct services or through an
agreement,
Does not require continuous on-premise
supervision at the CAH’S pharmacy,
May be accomplished through regularly
scheduled visits, and/or telemedicine in
accordance with law and regulation and
accepted professional principles,
A single pharmacist must be responsible for
the overall administration of the pharmacy,
179
Pharmacist
276
The pharmacist must be responsible for
developing, supervising, and coordinating all
the activities of the CAH-wide pharmacy
service,
 And must be thoroughly knowledgeable about
CAH pharmacy practice and management,
 Job description or the written agreement for the
responsibilities of the pharmacist should be
clearly defined and include development,
supervision and coordination of all the activities
of pharmacy services,
180
Pharmacy
276
Pharmacy must have sufficient staff in
types, numbers, and training to provide
quality services, including 24 hour, 7-day
emergency coverage,
Must have enough staff to provide accurate
and timely medication delivery, ensure
accurate and safe medication
administration,
 Staff to participate in PI,
 System so medication orders get to the
pharmacy and drugs back to patients promptly,
181
Pharmacy
276
Must keep records of the receipt and
disposition of all scheduled drugs,
 Pharmacist must make sure all drug records
are in order and that an account of all
scheduled drugs is maintained and
reconciled,
 From point of entry to administration to patient
or destruction or return of drug to manufacturer,
 Must have a P&P and system to identify loss or
diversion of all controlled substances,
182
Pharmacy
276
The P&P established to prevent
unauthorized usage and distribution must
provide for an accounting of the receipt and
disposition of drugs,
All prescribers’ medication orders (except in
emergency situations) should be reviewed
for appropriateness by a pharmacist before
the first dose is dispensed,
Note in next slide where CAH cited if no
initial pharmacy review done when
pharmacy closed (use tele-pharmacy)
183
First Dose Rule
 Therapeutic appropriateness of a patient’s
medication regimen;
 Therapeutic duplication,
 Appropriateness of the route and method of
administration;
 Medication-medication, medication-food, medicationlaboratory test and medication-disease interactions;
 Clinical and laboratory data to evaluate the efficacy
of medication therapy to anticipate or evaluate
toxicity and adverse effects; and
 Physical signs and clinical symptoms relevant to the
patient’s medication therapy.
184
Drug Interactions Checker
www.drugs.com/drug
_interactions.php
185
Drug Interaction Checker
http://reference.medscape.com/druginteractionchecker
186
Pediatric Drug Interaction Checker
187
Drug Interaction Checker
http://dir.pharmacy.dal.ca/dr
ugprobinteraction.php
188
Epocrates Online Checker
https://online.epocrates.com/home
189
Incompatibility Charts
hwww.ivmedic
ationcompatib
ilitychart.com/
190
Pharmacy
USP 797
276
Sterile products should be prepared and
labeled in a suitable environment by
appropriately trained and qualified
personnel,
Remember the USP 797, officially
introduced on 1-1-04 and became
enforceable by FDA,
Also adopted by TJC and many state
pharmacy boards,
Information is available at www.usp.org
191
Pharmacy
Pharmacy should participate in CAH
decisions about emergency
medication kits,
Supply and provision of emergency
medications stored in the kits must be
consistent with standards of practice,
 and appropriate for a specified age
group or disease treatment,
192
Pharmacy
Pharmacy should be involved in
the evaluation, use and
monitoring of drug delivery
systems (IV pumps, PCA)
Schedule Drugs and potential
for error of administration
devices,
 Including automated drugdispensing machines (Pyxis,
Omnicell, Meditol et. al.),
193
Pharmacy
 Medications must be prepared safely,
 Safe preparation procedures could
include;
 Only the pharmacy compounds or
admixes all sterile medications, intravenous
admixtures, or other drugs except in
emergencies or when not feasible (for
example, when the product’s stability is
short).
 Staff uses safety materials and equipment
while preparing hazardous medications.
194
Pharmacy
Whenever medications are prepared, staff
uses appropriate techniques to avoid
contamination during medication preparation,
which include, but are not limited, to the
following:
 Using clean or sterile technique as
appropriate;
 Maintaining clean, uncluttered, and
functionally separate areas for product
preparation to minimize the possibility of
contamination;
195
Pharmacy
 Using a laminar airflow hood or other
appropriate environment while preparing
any intravenous (IV) admixture in the
pharmacy, any sterile product made from
non-sterile ingredients, or any sterile
product that will not be used with 24 hours;
and
 Visually inspecting the integrity of the
medications.
196
Drug Storage
276
All drugs must be kept in a locked room
or container,
If the container is mobile or readily
portable, when not in use, it must be
stored in a locked room, monitored
location, or secured location that will
ensure the security of the drugs,
Must be stored in a manner to prevent
access by unauthorized individuals,
197
Drug Storage
276
Persons without legal access to drugs
cannot have unmonitored access to
drugs,
 Cannot have keys to medication
storage rooms, carts, cabinets, or
containers (housekeepers, security),
Drug storage is a big issue with both
CMS and the Joint Commission
198
Nursing Med Carts/Anesthesia Cart
When not in use, nursing medication
carts, anesthesia carts, and other
medication carts that contain drugs,
Must be locked or stored in a locked
storage room,
If cart is in use and unlocked,
someone with legal access to the
drugs in the cart must be close by
and directly monitoring the cart (276),
199
Outdated Drugs
276
Must have a pharmacy labeling, inspection,
and inventory management system that
ensures that outdated, mislabeled, or
otherwise unusable drugs are not available
for patient use,
Surveyor will make sure staff is familiar with
medication P&P,
Need policy to ensure P&P are periodically
reviewed,
 Will look to see if access to concentrated solutions
is restricted (KCL, NaCl greater than 0.9%),
200
Surveyor Procedure

Look for policy for the safeguarding, transferring
and availability of keys to the locked storage
area,

Inspect the pharmacy and where medications
are stored,
 Inspect patient-specific and floor stock
medications to identify expired, mislabeled or
unusable medications,
 If the unit dose system is utilized, verify that each
single unit dose package bears name and
strength of the drug, lot and control number
equivalent, and expiration date.
201
Surveyor
276
Review P&P to determine who is
designated to remove drugs from the
pharmacy or storage area,
 Determine if the pharmacist routinely
reviews the contents of the after-hours
supply to determine if it is adequate to meet
the after-hours needs of the CAH.
Interview the Pharmacy Director,
pharmacist and pharmacy employees to
determine their understanding of the
controlled drug policies,
202
Reporting ADR and Errors
277
 Procedures for reporting adverse drug
reactions and errors in the
administration of drugs,
 Written P&P to require these be
reported immediately to practitioner
who ordered the drug,
 Entry should be made in the MR,
 Significant ADRs should be reported to the
FDA in accordance with MedWatch
program,
203
Reporting ADR and Errors
277
Important to flag new types of mistakes
as they occur and create systems to
prevent their recurrences (system
analysis approach),
System should work through those
mistakes and continually improve and
refine things, based on what went wrong
(example RCA),
See sample forms to use for RCA and
FMEA,
204
Reporting ADR and Errors
277
Reduction of medication error and
adverse reactions by effective
reporting systems that proactively
identify causative factors and are used
to implement corrective actions to
reduce or prevent reoccurrences
(FMEA),
Need to develop definition of
medication error that includes near
misses,
205
High Risk Meds/Definition 277
System to minimize high risk
medications (chemo, insulin, Heparin),
Need to have a policy on high alert
drugs and what you do (double checks)
Such systems could include:
checklists, dose limits, pre-printed
orders, special packaging, special
labeling, double-checks and written
guidelines,
206
http://ismp.org/Tools/highalertmedication
s.pdf
207
High Alert How to Guide IHI
www.ihi.org/NR/rdonlyres/8B2475CD-56C7-4D9B-B359-801F3CC3A8D5/0/HighAlertMedicationsHowToGuide.doc
208
209
210
Medication Error is Defined as
Mention NCCMERP definition of medication error,
Any preventable event that may cause or lead to
inappropriate medication use or patient harm while
the medication is in the control of the health care
professional, patient, or consumer. Such events
may be related to professional practice, health
care products, procedures, and systems, including
prescribing; order communication; product
labeling, packaging, and nomenclature;
compounding; dispensing; distribution;
administration; education; monitoring; and use.”
211
Medications Errors
277
Can’t just rely on just incident
reports to identify medication
errors and ADE,
Proactive includes observation of
medication passes,
Concurrent and retrospective
review of patient’s clinical records,
ADR surveillance team,
212
Medications Errors
277
Implementation of medication usage
evaluations for high-alert drugs,
 and identification of indicator drugs or
“patient signals” that, when ordered, or
noted automatically generate a drug
regimen review for a potential ADE,
IHI calls them trigger drugs and has
three tools for hospitals to reduce
errors
213
Indicator Drugs (Trigger Drugs)
Monitor Digibind usage and develop protocol for
appropriate use,
Monitor use of reversals agents such as
Romazicon and Narcan to look for unreported
cases of adverse events,
Narcan, antihistamines, Vitamin K,
IV glucose, glucagon,
Epinephrine, topical calamine,
Phentolamine, digibind, protamine,
hyaluronidase,
Kayexalate, anti-emetics and anti-diarrheas,
214
215
216
Monitor Medication Errors 277
Must have method to measure the
effectiveness of its reporting system,
And whether system is identifying as many
med errors and ADE as would be expected
by benchmark studies,
Need non-punitive reporting system or
people will not report errors (many balance
with Just Culture),
Pharmacist should be readily available by
telephone or other means to discuss drug therapy,
interactions, side effects, dosage etc,
217
Medication Alerts
The CAH should have a means to
incorporate external alerts and/or
recommendations from national
associations and governmental
agencies for review and facility policy
and procedure revision consideration.
National associations could include Institute for
Safe Medications Practice, National Coordination
Council for Medication Error Reporting and
Prevention, The Joint Commission (no longer
called JCAHO) , ISMP, IHI, USP, and ASHP etc.
218
Medication Alerts
Governmental agencies may include;
 Food and Drug Administration (FDA),
 Med Watch Program, and
 Agency for Health Care Research
and Quality (AHRQ).
219
Websites
 National Patient Safety Foundation at the AMAwww.ama-assn.org/med-sci/npsf/htm,
 The Institute for Safe Medication Practiceswww.ismp.org
 U.S. Pharmocopiedia (USP) Convention, Inc.www.usp.org
 U.S. Food and Drug Administration MedWatchwww.fda.gov/medwatch
 Institute for Healthcare Improvement- www.ihi.org,
 AHRQ- www.ahrq.gov,
 Sentinel event alerts at www.jointcommission.org,
220
Additional Resources
 American Pharmaceutical Associationwww.aphanet.org
 American Society of Heath-System Pharmacistswww.ashp.org
 Enhancing Patient Safety and Errors in Healthcarewww.mederrors.com
 National Coordinating Council for Medication Error
Reporting and Prevention-www.nccmerp.org,
 FDA's Recalls, Market Withdrawals and Safety
Alerts Page:
http://www.fda.gov/opacom/7alerts.html
221
Drug Orders/Returns
277
 Pharmacy must ensure that drug orders are
accurate and that medications are administered
as ordered,
 When medications are returned unused, the
pharmacy should determine the reason the
medication was not used (CMS calls this
medication reconciliation and different from Joint
Commission (TJC)),
 Example: Did the patient refuse the medication,
was there a clinical reason the medication was
not used, was the medication not used due to
error?
222
P&P to Minimize Med Errors
277
Policies should include:
• High-alert medications with dosing
limits, administration guidelines,
packaging, labeling and storage;
• Limiting the variety of medicationrelated devices and equipment. For
example, limit the types of generalpurpose infusion pumps to one or two;
• Availability of up-to-date medication
information;
223
Required Drug Policies 277
 Availability of pharmacy expertise
such as having a pharmacist
available on-call when pharmacy
does not operate 24 hours a day,
 Standardization of prescribing and
communication practices,
224
Beers list of Inappropriate Meds
These are drugs that should be avoided in
patients who are over 65!
Updated in 2012
Includes drugs not to be used for certain
diseases
 High risk drugs include Indocin, Talwin, Tigan,
Dalmane, Muscle relaxants (Robaxin, Somam
Flexeril etc.), Elavil, Triavil, Equanil, Librium,
Aldoment, Diabense, all barbituates except Pb,
Demerol, Ticlid, Toradol, Norflex, Ismelin, Hylorel,
Mellaril, Mineral oil, etc.
225
Beers list of Inappropriate Meds
Heart failure- Norpace, high sodium drugs,
HTN-pseudoephedrine, diet pills,
Seizure- Clozaril, Thorazine, Navane,
Mellaril,
Anticoagulants-ASA, Plavix, Persantine,
Ticlid,
Categories for depression, Insomnia,
Anorexia, Stress incontinence, syncope,
etc.
226
227
Required Pharmacy P&P
• Standardization of prescribing and
communication practices;
• Avoidance of certain abbreviations (TJC IM
Chapter has nine, no longer NPSG);
• All elements of the order such as dose,
strength, units (metric), route, frequency,
and rate;
• Alert systems for look-alike and sound-alike
drug names (now 2 times the number);
228
TJC Do Not Use Abbreviations
Potential Problem
Set
Item
Abbreviation
Preferred Term
1.
1.
U (for unit)
Mistaken as zero,
four or cc
Write "unit"
2.
2.
IU (for
International unit)
Mistaken as IV
(intravenous) or 10
(ten)
Write
"International unit"
3.
3.
4.
Q.D.,
Q.O.D.
(Latin abbreviation
for once daily and
every other day)
Mistaken for each
other. The period
after the Q can be
mistaken for an "I"
and the "O" can be
mistaken for "I".
Write "daily" and
"every other day
229
LASA Drugs
Be sure to take action when a problem is
noted,
Decide if you will take thru risk
management, pharmacy, medical staff, or
use the PI process
Look at your list on at least a yearly basis
and update as necessary,
ISMP newsletters are a good source of
information on current cases of look
alike/sound alike drugs,
230
LASA
TJC has MM standard on LASA
 Policy need to includes precautions for
LASA medications
It is a much bigger problem according to
recent research so USP has database
hospitals can check for LASA drugs
8th Annual MedMaRX report issued in 2008
shows problems with 3,170 drug pair
names which is doubled number since
2004
231
http://ismp.org/
232
233
Required Pharmacy Policies 277
 Use of facility approved pre-printed order
sheets whenever possible;
 A voluntary, non-punitive, reporting system to
monitor and report adverse drug events
(including medication errors and adverse drug
reactions);
 The preparation, distribution, administration
and proper disposal of hazardous medications;
 Medication recalls;
 Policies and procedures are reviewed and
amended secondary to facility-generated
reports of adverse drug events,
234
Non-Punitive Environment
Studies showed that if you have punitive
environment errors will not be reported,
Most of serious errors are made by long term
employee with unblemished records,
It was the system that actually lead to the error,
Change the environment or culture-called system
analysis,
Important to have a non-punitive environment,
We need to move beyond the culture of blame so we
can find out what errors are occurring,
Balance this with Just Culture,
235
Surveyor Procedure 277
 What drug information is available at the
nursing stations?
 Will look at the pharmacy P&P, formulary
and, if there is a pharmacy and therapeutic
committee, the minutes of the committee
meetings,
 Are the above P&P present,
 Review medical records to make sure
medication errors are reported promptly,
 Make sure generated sufficient number of
medication errors,
236
Infection Control
278
A system for identifying, reporting, investigating and
controlling infections and communicable diseases
of patients and personnel,
 Must have an active surveillance program that
includes specific measures for prevention,
 Early detection, control, education, and
investigation of infections and communicable
diseases,
 Remember the IC Worksheet
 CMS gets $50 million grant in 2011 to enforce IC
standards and in 2012 HHS gets a billion dollars and
some hospitals report increased scrutiny
237
Infection Preventionist or IP
238
Infection Control
278
Must be a mechanism to evaluate the
effectiveness of the program (IC plan) and to
provide corrective action when necessary ,
Program must include implementation of
nationally recognized systems of infection
control guidelines,
So what’s in your IC Plan?
 Such as CDC, OSHA, and APIC, SHEA, AORN,
** nosocomial infections are more recently referred
to as Healthcare- associated infections (HAI),
239
240
241
242
243
Infection Control Websites
 Association for Professionals in Infection Control
and Epidemiology (APIC) infection control
guidelines at www.apic.org,
 Centers for Disease Control and Preventionwww.cdc.gov,
 Occupational Health and Safety Administration
(OSHA)- www.osha.gov,
 The National Institute for Occupational Safety and
Health NIOSHwww.cdc.gov/niosh/homepage.html,
244
Additional Resources
See the CDC Guideline for Disinfection and
Sterilization in Healthcare Facilities, 2008 1
AORN in the Perioperative Standards and
Recommended Practices has a chapter on
sterilization and disinfection including many
on steam sterilization
APIC is good source of information2


1 http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf
2 www.apic.org
245
246
247
Additional Resources
2011 CDC Guidelines for Prevention of
Intravascular Catheter Related Infections,
CDC Guidelines for the Prevention of
catheter-Induced Urinary Tract Infections,
December 2009,
 http://www.cdc.gov/hicpac/cauti/002_cauti_toc.h
tml
AHRQ toolkit
 http://www.ahrq.gov/qual/haiflyer.htm
248
CDC 2011 Intravascular Catheter
Guidelines
http://www.cdc.gov/hicpac/BSI/B
SI-guidelines-2011.html
249
Infection Control Video
HHS has published a training video that
every nurse, physician, infection
preventionist and healthcare staff should see
This includes risk managers
It is an interactive video
Called Partnering to Heal: Teaming Up
Against Healthcare-Associated Infections
 Go to http://www.hhs.gov/partneringtoheal
 HHS wants to decrease HAI by 40% in 2013, want
1.8 million fewer injures and can save 60,000 lives
250
www.hhs.gov/ash/initiatives/hai/training/
251
CA-UTI Resources
Pa Patient Safety has toolkit to prevent CAUTIs,
 http://patientsafetyauthority.org/EducationalTool
s/PatientSafetyTools/cauti/Pages/home.aspx
APIC guidelines to eliminate catheterassociated UTI
AORN article Jan 2010 on new scip
measure regarding urinary catheter removal
 at
www.aorn.org/News/Managers/November2009Issue/Ca
theter/
252
CA-UTI Resources
IDSA as the “Diagnosis, Prevention, and
Treatment of Catheter-Associated Urinary
Tract Infections in Adults: 2009 International
Clinical Practice Guidelines from the
Infectious Disease Society of America
 http://cid.oxfordjournals.org/content/50/5/625.full
Iowa Healthcare Collaborative toolkit
 http://www.ihi.org/IHI/Programs/ImprovementM
ap/PreventCatheterAssociatedUrinaryTractInfec
tions.htm
253
Infection Control Policies
278
 Definition of nosocomial infections (now
called HAI) and communicable diseases;
 Measures for identifying, investigating,
and reporting nosocomial infections and
communicable diseases;
 Measures for assessing and identifying
patients and health care workers,
including personnel, contract staff (e.g.,
agency nurses, housekeeping staff), and
volunteers, at risk for infections and
communicable diseases;
254
Infection Control Policies 278
 Methods for obtaining reports of
infections and communicable
diseases on inpatients and health
care workers,
 including all personnel, contract such
as agency nurses, housekeeping
staff, and volunteers, in a timely
manner;
255
Infection Control Policies
278
 Measures for the prevention of infections,
especially infections caused by organisms that are
antibiotic resistant or in other ways
epidemiologically important; device-related
infections (e.g., those associated with intravascular
devices, ventilators, tube feeding, indwelling
urinary catheters, surgical site infections; and
those infections associated with trach care,
respiratory therapy, burns, immunosuppressed
patients, and other factors which compromise a
patient's resistance to infection; (VAP bundle,
central line bundle, SCIP,)
256
Infection Control Policies
278
 Measures for prevention of communicable
disease outbreaks, especially tuberculosis;
 Provision of a safe environment consistent
with nationally recognized infection control
precautions, such as the current CDC
recommendations for the identified infection
and/or communicable disease;
 Isolation procedures and requirements for
infected or immunosuppressed patients;
 Use and techniques for standard
precautions;
257
Infection Control Policies
278
 Education of patients, family members and
caregivers about infections and
communicable diseases;
 Methods for monitoring and evaluating
practices of asepsis;
 Techniques for hand washing, respiratory
protections, asepsis, sterilization, disinfection,
food sanitation, housekeeping, fabric care, liquid
and solid waste disposal, needle disposal,
separation of clean from dirty, as well as other
means for limiting the spread of contagion;
258
APIC Brochures
APIC has a number of educational
brochures that hospitals can download and
provide to staff and patient
Includes 10 tips to prevent the spread of
infection and hand hygiene for patients and
one for healthcare workers
Information to patients is on standard
precautions (hand hygiene) and
Transmission precautions for patients with
certain diseases (contact precautions)

1www.apic.org/AM/Template.cfm?Section=Education_Resources&Template=/TaggedPag
e/TaggedPageDisplay.cfm&TPLID=91&ContentID=8738
259
260
Infection Control Policies 278
 Authority and indications for obtaining
microbiological cultures from patients;
 A requirement that disinfectants,
antiseptics, and germicides be used in
accordance with the manufacturers'
instructions to avoid harming patients,
particularly central nervous system effects
on children;
 Orientation of all new personnel to
infections, communicable diseases, and to
the infection control program;
261
Flash Sterilization (Immediate Use)
262
Infection Control Policies 278
 Measures for the screening and evaluation of
health care workers, including all staff,
contract workers such as agency nurses,
housekeeping staff, and volunteers, for
communicable diseases, and for the evaluation
of staff and volunteers exposed to patients with
non-treated communicable diseases;
 Employee health policies regarding infectious
diseases and when infected or ill employees,
including contract workers and volunteers, must
not render patient care and/or must not report
to work;
263
Infection Control Policies 278
 A procedure for meeting the reporting
requirements of the local health
authority (such as the state
department of health);
 Policies and procedures developed in
coordination with Federal, State, and
local emergency preparedness and
health authorities to address
communicable disease threats and
outbreaks,
264
Infection Control Log
 Recommended that the infection control officer or
officers maintain a log of all incidents related to
infections and communicable disease,
 Including those identified through employee health
services,
 Log is not limited to HAI,
 Deleted by July 16, 2012 for FR for PPS hospitals but not from the
CAH manual yet
 All incidents of infection and communicable disease
should be included in the log,
 Log documents infections and communicable diseases of
patients and all staff (patient care, non patient care,
employees, contract staff and volunteers).
265
Role of Leaders in IC 278
CEO, MS, and DON must ensure there is
hospital wide QA program,
And infection control training programs that
address problems identified through the IC
program,
 Then revise the program,
 Designate an infection control officer,
 Person must be qualified and is responsible for
IC functions and is responsible to implement the
P&P developed by IC Committee,
266
Infection Preventionist
Is responsible for (should include in job
description);
Developing a system for identifying,
investigating, reporting, and preventing the
spread of infections and communicable
diseases among patients and personnel,
including contract staff and volunteers;
Identifying, investigating and reporting
infections and outbreaks of communicable
diseases among patients and personnel,
including contract staff and volunteers,
especially those occurring in clusters;
267
Infection Control Preventionist
Preventing and controlling the spread of
infections and communicable diseases
among patients and staff;
Cooperating with CAH-wide orientation
and in-service education programs;
Cooperating with other departments and
services in the performance of quality
assurance activities; and
Cooperating with disease control activities
of the local health authority.
268
www.cdc.gov/nhsn/mdro_cdad.htm
l
269
270
271
272
Dietary 279
If the CAH furnishes inpatient services,
Procedures must be in place that ensure
that the nutritional needs of inpatients are
met in accordance with recognized dietary
practice,
 A CAH is not required to prepare meals
itself.
Can obtain meals under contract,
Infection control issues in dietary hit hard
273
Dietary 279
Food and dietetic services must
be organized,
Directed and staffed in such a
manner to ensure that the
nutritional needs of the patients
are met in accordance with
practitioners’ orders,
 And recognized dietary practices,
274
Dietary Policies
279
 Availability of a diet manual and
therapeutic diet menus to meet patients’
nutritional needs,
 Frequency of meals served,
 System for diet ordering and patient tray
delivery,
 Accommodation of non-routine occurrences
such as enteral nutrition (tube feeding), total
parenteral nutrition, peripheral parenteral
nutrition, change in diet orders, early/late
trays, nutritional supplements, etc.,
275
Dietary Policies 279
 Integration of the food and dietetic
service into the PI and Infection
Control programs;
 Guidelines for acceptable hygiene
practices of food service
personnel; and
 Guidelines for kitchen sanitation.
276
Dietary Compliance
279
Must be in compliance with Federal and
State licensure requirements for food,
 And dietary personnel as well as food
service standards, laws and regulations.
Must have qualified director of food and
dietetic services
 Employed or contracted
Must be delegated this responsibility by
Board and MS,
277
Dietary Policies Required 279
 Safety practices for food handling;
 Emergency food supplies;
 Orientation, work assignments,
supervision of work and personnel
performance;
 Menu planning, purchasing of foods and
supplies, and retention of essential records
such as cost, menus, personnel, training
records, QA reports, etc.; and
 Dietary service PI program
278
Qualified Dietician
The dietitian’s responsibilities include
(put in job description), but are not
limited to:
Approving patient menus and nutritional
supplements;
Patient, family, and caretaker dietary
counseling;
Performing and documenting nutritional
assessments and evaluating patient tolerance
to therapeutic diets when appropriate;
279
Dietician’s Job Description
Collaborating with other services (e.g.,
medical staff, nursing services, pharmacy
service, social work service, etc.) to meet
the nutritional needs of the patients; and
Maintaining pertinent patient data necessary
to recommend, prescribe, or modify
therapeutic diets as needed to meet the
nutritional needs of the patients.
 Need a physician’s order for the therapeutic diet
 If consulted make sure verbal order from doctor
or doctor write the order
280
Dietary
Must have dietary support staff,
HR file should document their competency,
Must follow recognized dietary practices,
 Must follow national standards such as current
Recommended Dietary Allowances (RDA) or
the Dietary Reference Intake (DRI) of the Food
and Nutrition Board of the National Research
Council.
 **IOM recommended dropped name of RDA in
favor of DRI or dietary reference intakes,
 ** “Dietary Guidelines for Americans 2011”
published- www.dietaryguidelines.gov
281
282
Dietary
Menus must be nutritionally balanced,
Must meet needs of patients,
Screening criteria should be developed to
identify patients at nutritional risk (usually
done as part of nursing admission
assessment),
Is identified as an altered nutritional
status, a nutritional assessment should
be performed,
283
Nutritional Assessment includes;
All patients requiring artificial nutrition by
any means (i.e., enteral nutrition (tube
feeding), total parenteral nutrition, or
peripheral parenteral nutrition);
Patients whose medical condition,
surgical intervention, or physical status
interferes with their ability to ingest,
digest or absorb nutrients;
284
Nutritional Assessment
Patients whose diagnosis or presenting
signs/symptoms indicates a compromised
nutritional status (e.g., anorexia nervosa,
bulimia, electrolyte imbalances, dysphagia,
malabsorption, end stage organ diseases,
etc.); and
Patients whose medical condition can be
adversely affected by their nutritional intake
(e.g., diabetes, congestive heart failure,
patients taking certain medications, renal
diseases, etc.).
285
Therapeutic Diets
Therapeutic diets must be prescribed by
practitioner in writing by the practitioner
responsible for patient’s care,
Documented in the MR including
information about the patient’s tolerance,
Evaluate for nutritional adequacy,
Manual must be available for nursing, FS,
and medical staff,
Dieticians can only make
recommendations and can’t order,
286
Patient Care Policies 280
The P&Ps must be reviewed at least once a
year,
Reviewed by group of professional
personnel,
Make sure P&P are consistent with the
standard of care
Cite the authority in the reference section at
the end of the policy such as the AORN
Perioperative Standards and Recommended
Practices or ASPAN
287
Patient Services 281
6-7-2013
 Must provide basic services as those provided in
doctor’s office or at entry of healthcare organization
like an outpatient department and ED,
 Changed from Direct Services to Patient Services
 Can provide directly or under contract
 Must provide diagnostic and therapeutic services
and have supplies as that typically found in an
ambulatory healthcare setting and a physician’s
office
 These services include medical history, physical
examination, specimen collection, assessment of
health status, and treatment for a variety of medical
conditions.
288
Outpatient Department 281
 Must provide adequate services, equipment, staff,
and facilities adequate to provide the outpatient
services,
 Must follow acceptable standards of practices such
as ACR, AMA, ACOS, etc.,
 OP Dept must be integrated with inpatient services
such as MR, lab, radiology, anesthesia or other
diagnostic services,
 CAH physician or non-physician practitioner must
be available to treat patients at the CAH when such
outpatient services are provided
 For those outpatient services that fall only within the scope of
practice of a physician or non-physician practitioner
289
Tag 281 Many Changes Patient Services
290
Rehab Services
DELETED
If rehab is provided, must have appropriate
equipment and adequate staff,
Scope of what is offered must be in writing
and approved by MS,
Need person to direct department who must
be qualified and supervise supportive
personnel,
MS have to define in writing the
competencies and qualifications of the
director,
Director must have annual evaluation,
291
Rehab Treatment Plan DELETED
Initiate plan of treatment based on
evaluation and assessment with input from
family and with order and include short and
long term goals,
Must document changes in the treatment
plan,
Person must be within scope of practice
they are performing,
Surveyor will review medical records to
patient later admitted that OP information
has been included,
292
Lab Services 282
6-7-2013
Must provide basic lab services to include,
 Urine dipstick or tablet including urine ketones,
 Hemoglobin or hematocrit,
 Blood glucose,
 Stool for occult blood,
 Pregnancy tests,
 Primary culturing for transmittal to certified lab,
Will need written policy to make sure all labs tests
are recorded in the MR,
July 16, 2012 where lab and radiology dept do not
have to be a direct service anymore
293
Lab 282
Must have these basic lab services,
Must provide emergency services 24 hours/7 days
a week,
Must have current CLIA certificate and if contracted out
make sure they have a CLIA certificate
Scope of services and complexity must be adequate to meet
the needs of the patients,
Can be employed or contract services,
Patient lab results are medical records and must comply with
the MR chapter
Must have written P&P for collecting, preserving,
transport, receipt if tissue specimen results,
294
Lab 282 Revised 6-7-2013
295
Radiology Services 283 6-7-2013
Radiology services must be
provided by qualified staff,
 Can be provided as a direct
service or through a contract,
And do not expose patients
or staff to radiation hazards,
Must have services to meet
the needs of its patients at all
times,
296
Radiology Services
283
Can offer minimal set or more complex,
according to needs of the patients including
nuclear medicine,
Hospital has flexibility to decide the types
and complexities of radiologic services
offered
 Interpretation can be contracted out
 Diagnostic, therapeutic, and nuclear medicine,
must be provided in accordance with acceptable
standards of practice and must meet
professionally approved standards for safety
297
Radiology Services
283
 Scope or what you do has to be in P&Ps approved
by board or responsible party,
 Must be consistent with state law
 If telemedicine is used must comply with
telemedicine standards
 And by standards recommended by nationally
recognized professions such as the AMA, Radiology
Society of North America, Alliance for Radiation Safety in
Pediatric Imaging, ACC, American College of Neurology,
ACP, and ACR,
 Example would be the ACR 2013 MRI safety
standards and 2013 contrast manual
298
Radiology Services 283
P&P on adequate radiation shielding for
patients, personnel and facilities which
includes:
 Shielding built into the physical plant
 Types of personal protective shielding to use
and under what circumstances
 Types of containers to be used for radioactive
materials
 Clear signage identifying hazardous radiation
area
299
Radiology Policies Required
 Labeling of all radioactive materials,
including waste with clear identification of the
material
 Transportation of radioactive materials
between locations within the CAH;
 Security of radioactive materials, including
determining who may have access to
radioactive materials and controlling access
to radioactive materials;
 Periodic testing of equipment for radiation
hazards;
300
Radiology Policies
 Periodic checking of staff regularly exposed to
radiation for the level of radiation exposure, via
exposure meters or badge tests
 Storage of radio nuclides and radio
pharmaceuticals as well as radioactive waste;
and
 Disposal of radio nuclides, unused radio
pharmaceuticals, and radioactive waste,
 To ensure periodic inspections of equipment,

Make sure problems are corrected in timely manner
and have evidence of inspections and corrective
actions
301
Radiology Policies 283 6-7-2013
There must be written policies developed
and approved by the medical staff to
designate which radiological tests must be
interpreted by a radiologist,
MR chapter standards apply
Make sure patient shielding aprons are
maintained properly and inspected
Surveyor will review equipment
maintenance reports (PM)
Make sure staff know P&Ps
302
Radiology Policies
283
Supervision must include that all files, scans,
and images are kept in a secure place and
are retrievable,
Written policy, consistent with state law on
which personnel can operate radiology
equipment and do procedures,
Need copies of all reports and printouts,
Written policy to ensure integrity of
authentication,
 See tag 283 for required signage on
hazardous radiation areas and more
303
Tag 283 Blue Box Advisory
304
Emergency Procedures 284 6-7-13
Must provide medical emergency services
as a first response to common life
threatening injuries and acute illness,
 Emergency services can done directly or
through contracted services
 Individuals providing the services must to be
able to recognize a patient need for emergency
care
 Must provide initial interventions, treatment, and
stabilization of any patient who requires
emergency services
305
Agreements 285
7-15-2011
306
Agreements 285
CAH has to have agreements with one or
more providers or suppliers participating
under Medicare to furnish services to
patients
CMS made an exception since distantsite telemedicine entity (DSTE) is not
required to be a Medicare provider
Agreements such as for obtaining outside
lab tests
307
Contracted Services 286
Must have agreement or arrangement with
one or more providers or supplies
participating under Medicare to provide
services to patients,
Need to describe routine procedures such
as for obtaining outside lab tests,
Governing body is responsible for these
services provided,
These must be evaluated thru PI and board
must take action if problems occur,
308
Contracted Services 286-289
CAH must have agreements with 1 or more
facilities to provide care to inpatients,
Arrangement with 1 or more doctors to
provide care,
If labs provide additional diagnosis and
clinical lab services must be in compliance
with CLIA and lab will be surveyed separately
for compliance,
Arrangements for food and inpatient
nutritional needs to be meet,
309
Contracted Services
Surveyor will review medical records
of patients transferred to make sure,
Transfer patients were accepted,
Patients referred for lab or dx tests
had the tests performed,
Need to keep list of all services
provided under contract or
agreement,
310
Nursing Care 294
Nursing service must met the needs of
patients,
Nursing service must be well organized
service of CAH,
Must be under direction of a RN,
Nursing staff must be trained and oriented,
Adequately supervised,
Nursing personnel must know P&Ps,
 CAH RN must conduct the supervision and
evaluation of each non-CAH nursing staff,
311
Nursing Care 294
Surveyor is to observe nursing care in
progress,
To determine if staffing is adequate,
Will look at nursing care plans, medical
records, accident and investigative reports,
staff schedules, and P&P,
Will review the method for orientation and
needs to include nursing P&P, emergency
procedures, CAH and unit, and safety
P&P,
312
RN 295
 RN must provide the care for each patient or
assign care to other personnel,
 Including SNF and swing be patients,
 Care must be provided in accordance with patient
needs,
 RN must make all patient care assignments,
 Assignments must take into consideration
complexity of patient’s care,
 Will look at written staffing plans,
 Staff must be competent,
 Make sure if temporary nurses used they are
oriented and supervised,
313
RN Supervising Care
296
A RN must supervise and evaluate the
nursing care for each patient (or if state law
allows a PA),
Includes SNF level is a swing bed,
Must evaluate the patient’s needs,
Make sure nurses are licensed,
Will make sure staff have yearly
evaluations,
314
Drugs and IVs
297
All drugs and IVs are administered
under the supervision of RN or MD, (or
a PA if allowed by state law),
Make sure all orders are signed off,
 Be sure there is signature and date and
TIME
Orders must be written with the
acceptable standard of care,
315
Drugs and IVs
Drugs must be administered and
prepared in accordance with the
standard of care,
Will review medication record to make
sure consistent with doctor’s orders,
Observe nurse pass meds and
determine if policies followed,
How do you monitor drugs and IVs for
PI?
316
Verbal Orders
297
All orders must be legible, dated,
TIMED, and authenticated (signed) by
the practitioner responsible for care,
Includes VERBAL ORDERS,
Ordering practitioner signs off the verbal
order and it must include a date and time,
VO must be used infrequently or for
convenience and limited to urgent
situations,
317
Verbal Order Policy Should Include:
 Describe limitations or prohibitions on use
of verbal orders;
 List the elements required for inclusion in a
complete verbal order;
 Describe situations in which verbal orders
may be used;
 List and define the individuals who may
send and receive verbal orders; and
 Provide guidelines for clear and effective
communication of verbal orders.
318
Culture of Questioning
297
 CAHs should promote a culture in
which it is acceptable, and strongly
encouraged, for staff to question
prescribers when there are any
questions or disagreements about
verbal orders,
 Questions about verbal orders should
be resolved prior to the preparation, or
dispensing, or administration of the
medication,
319
Complete Order
Verbal medication orders must include:
 Name of patient; Age and weight of
patient, when appropriate; date and
time of the order; drug name; dosage
form (e.g., tablets, capsules, inhalants),
exact strength or concentration; dose,
frequency, and route; quantity and/or
duration; purpose or indication;
specific instructions for use; and name
of prescriber.
320
Medication Passes
297
 Surveyor will select a patient, review their
medication orders, review documentation of
medications given, and observe nurse pass
drugs,
 Will look at P&P, approved by MS, as to who
can pass meds and that P&Ps are followed,
 Will look to see if id band checked or the nurse
calls the patient by name,
 Will check PI to see if administration of drugs is
regularly monitored,
 Will ask nurses if they permitted to take
telephone orders,
321
Verbal Orders
297
A verbal order must be signed off as soon as
possible which would be the earlier of the
following:
The next time the prescribing practitioner
provides care to the patient, assesses the
patient, or documents information in the
patient’s medical record, or
The prescribing practitioner signs or initials
the verbal order within time frames
consistent with Federal and State law and
CAH policy
322
Verbal Orders
297
Must repeat back VO to prescriber,
All verbal orders must immediately be
commenced to writing and signed by the
person receiving the order,
VO must be documented in the medical
record,
Covering physician can sign the VO for his or
her partner,
 PA or NP can not co-sign MD/DO order,
 Must include above information in your policy on
verbal orders!
323
CMS Visitation Sept 7, 2011
www.cms.gov/SurveyCertificationGenI
nfo/PMSR/list.asp#TopOfPage
324
Visitation 1000 (Starts after Tag 297)
Must have P&P and process on visitation
 Including any reasonable restrictions or
limitations
Discusses 2004 JAMA article encouraging
open visitation in the ICU
Includes inpatients and outpatients
 Discusses role of support person for both
 Patient may want support person present
during pre-op preparation or post-op
recovery
325
Reasonable Restrictions 1000
Infection control issues
Can interfere with the care of other patients
Court order restricting contact
Disruptive or threatening behavior
Room mate needs rest or privacy
Substance abuse treatment plan
Patient undergoing care interventions
Restriction for children under certain age
326
Visitation 1000
Need to train staff on the P&P
Need to determine role staff will play in
controlling visitor access
Surveyor will verify you have a P&P
Will review policy to determine if restrictions
Is there documentation staff is trained?
Will make sure staff are aware of P&P on
visitation and can describe the policy for the
surveyor
327
Visitation 1001
Must inform each patient or their support
person, when appropriate, of their visitation
rights
Must include notifying patient of any
restrictions
Patient gets to decide who their visitors are
Can not discriminate against same sex
domestic partners, friend, family member
etc.
The patient gets to decide
328
Visitation 1001
Support person does not have to be the
same person as the DPOA
Support person can be friend, family
member or other individual who supports the
patient during their stay
 TJC calls it a patient advocate
Support person can exercise patient’s
visitation rights on their behalf if patient
unable to do so
329
TJC Help Prevent Errors in Your Care
www.jointcommission.org/speak_up_help_prevent_errors_in_your_care/
330
Visitation 1001
Hospital must accept patient’s designation of
an individual as a support person
 Either orally or in writing
 Suggest you get it in writing from the patient
When patient is incapacitated and no
advance directives on file then must accept
individual who tells you they are the support
person
 Must allow person to exercise and give them
notice of patients rights and exercise visitation
rights
331
Visitation 1001
Hospital expected to accept this unless two
individuals claim to be the support person
then can ask for documentation
 This includes same sex partners, friends, or
family members
 Need policy on how to resolve this issue
Any refusal to be treated as the support
person must be documented in the medical
record along with specific reason for the
refusal
332
Visitation 1001
Patient can withdraw consent and change
their mind
Must document in the medical record that
the notice was given
Surveyor is to look at the standard notice of
visitation rights
Will review medical records to make sure
documented
Will ask staff what is a support person and
what it means
333
Visitation 1002
Must have written P&P
Must not restrict visitors based on race,
color, sex, gender identify, sexual orientation
etc.
In other words, if a unit is restricted to two
visitors every hour the patient gets to pick
their visitors not the hospital
Suggest develop culturally competent
training programs
334
Nursing Care Plan
298
Nursing care plan must be developed and
kept current on all inpatients,
Starts on admission and includes discharge
planning,
Nursing care plans should include all
pertinent information and is based on
assessment,
Must be kept as part of the medical record,
Plan must describe goals, discharge planning,
physiological and psychosocial factors,
335
The End! Questions??
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
336
336
Part 3
337
Speaker
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
338
338
Medical Records
300
Must maintain clinical medical records system
in accordance with P&Ps,
Must have a system of patient records, ways
to identify the author and protect security of
MR,
Must be sure MR are not lost, stolen, or
altered or reproduced in authorized manner,
Limit access to only those authorized
persons,
Note HIPAA law changes effective
September 23, 2013
339
Medical Records
300
Must have current list of authenticates
signatures (like signature cards),
And computer codes and signature
stamps,
Must be adequately protected and
authorized by governing body,
Must cross reference inpatients and
outpatients,
If transfer to swing bed can use one MR but
need divider,
340
Medical Record
Both inpatient and swing bed must
have MR;
Admission, discharge orders,
progress notes, nursing notes,
graphics, laboratory support
documents, any other pertinent
documents, and discharge summaries,
Must retain MR and file them,
341
Medical Records
300
Must have system to be able to pull any old MR
within past 6 years,
24 hours a day and 7 days a week,
Inpatient or outpatient,
Surveyor will verify there is a MR for every
patient,
Will look to be stored in place protected from
damage, flood, fire, theft, etc.,
Must protect confidentiality of MR,
MR must be adequately staffed,
342
Medical Records
302
Must be legible, complete, accurate,
readily accessible and systematically
organized,
To ensure accurate and complete
documentation of all orders, test results,
evaluations, treatments, interventions, care
provided and the patient’s response to
those treatments, interventions and care.
Must have director of MR that has been
appointed by governing board (303),
343
Medical Records
303
MR must contain:
Identification and social data,
Evidence of properly executed informed
consent forms,
Pertinent medical history,
Assessment of the health status and health
care needs of the patient,
Brief summary of the episode, disposition,
and instructions to the patient;
344
Informed Consent 304
Include evidence of properly executed
informed consent forms for any procedures
or surgical procedures,
 Specified by the medical staff,
Or by Federal or State law, if applicable, that
require written patient consent,
 Informed consent means the patient or patient
representative is given the information,
explanations, consequences, and options needed
in order to consent to a procedure or treatment.
 See also tag 320,
345
Consider List of Procedures
Procedure Name
Consent
Requires Informed
Ablations
Yes
Amniocentesis
Yes
Angiogram
Yes
Angiography
Yes
Angioplasties
Yes
Arthrogram
Yes
Arterial Line insertion (performed alone) Yes
Aspiration Cyst (simple/minor)
No
346
Consider List of Procedures
Aspiration Cyst (complex)
Blood Administration
Blood Patch
Bone Marrow Aspiration
Bone Marrow Biopsy
Bronchoscopy
Capsule Endoscopy
Catherizations, Cardiac & vascular
Cardioversion
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
347
Informed Consent
304
A properly executed consent form
contains at least the following:
 Name of patient, and when
appropriate, patient’s legal guardian;
 Name of CAH;
 Name of procedure(s);
 Name of practitioner(s) performing
the procedures(s);
 Signature of patient or legal guardian;
348
Consent Form Must Include
 Date and time consent is
obtained;
 Statement that procedure was
explained to patient or guardian;
 Signature of professional person
witnessing the consent;
 Name/signature of person who
explained the procedure to the
patient or guardian.
349
Medical Records
304
MR must contain information such as progress
and nursing notes, medical hx., documentation,
records, reports, recordings, test results,
assessments etc. to:
• Justify admission;
• Describe the patient’s progress; and support
the diagnosis;
• Describe the patient’s response to
medications; and
• Describe the patient’s response to services
such as interventions, care, treatments,
350
Medical Records
Must maintain confidentiality of records,
What precautions are taken to ensure
confidentiality and prevent unauthorized
persons from gaining access,
MR retention period is 6 years and longer if
required by state (311),
When can records be removed ?
AHIMA has practice briefs that can be helpful
to hospitals at www.ahima.org,
351
AHIMA Practice Briefs www.ahima.org
352
Discharge Summary
304
A discharge summary discusses:
 The outcome of the CAH stay,
 The disposition of the patient,
 And provisions for follow-up care (any
post appointments such as home
health, hospice, assisted living, LTC,
swing bed services,
 Is required for all hospitals stays and
prior to and after swing bed admission,
353
Discharge Summary
304
Admitting practitioner must do,
MD/DO may delegate writing the discharge
summary to other qualified health care personnel
such as nurse practitioners and physician
assistants if state allows,
Surveyor will verify MS have specified which
procedures or treatments need informed consent,
Surveyor will verify consent forms contain all the
elements,
Will do review of closed and open MR-at least
10% of average daily census,
354
Discharge Summary
304
Recommendations to avoid unnecessary
readmissions;
 Make the appointment for the patient with the
PCP before discharge
 Dictate the discharge summary as soon as
patient is discharge
 Hospital has the responsibility to get the
discharge summary or medical record
information into the hands of the PCP before the
first visit
 Make appointment within 4 days after discharge
355
History and Physicals
305
All or part of H&P may be delegated to other
practitioners if allowed by state law and CAH
(see also tag 320),
However MD/DO assume full responsibility,
MD/DO must sign also,
Surveyor will look at bylaws to determine
when H&P must be done,
Make sure H&P on chart before patient goes
to surgery unless an emergency
 Important issue with CMS and TJC
356
Response to Treatment 306
The following must describe the
patient’s response to treatment;
 All orders,
 Reports of treatment and medications,
 Nursing notes,
 Documentation of complications,
 Other information used to monitor the
patients such as progress notes, lab
tests, graphics,
357
Medical Records
306
Must make sure MR get filed promptly,
All MR must contain all lab reports,
Radiology reports,
All vital signs,
All reports of treatment include
complications and hospital acquired
infections,
All unfavorable reaction to drugs,
358
Entries in the MR
307
Only those specified in the MS P&P can
write in the MR,
All entries must be DATED, TIMED, and
authenticated (must sign off each order),
If rubber stamps used-person must sign
they will be the only one who uses it,
Must have sanctions for improper use of
stamp, computer key or code signature,
Must date and time when a verbal order is
signed off,
359
Confidentiality of MR
308
Must maintain confidentiality of information,
Access to information limited to those who
need to know,
Safeguard MR, videos, audio,
Will verify only authorized people can
access MR contained in MR department
(which many call Health Information
Management),
 Need to release only with written authorization of
patient or authorized representative,
360
MR Policies
309
Need written P&P that govern the use
and removal of MR,
To include the conditions of release of
information,
Remember the federal HIPAA law on MR
confidentiality and privacy and ARRA,
HITECH, and breach notification law,
Written consent of patient required to
release (310),
361
Retention of MR
311
Records are retained for at least 6 years
from date of last entry,
 And longer if required by State or federal
law (OSHA, FDA, EPA),
 or if the records may be needed in any
pending proceeding,
Can be in hard copy, microfilm or computer
memory banks,
AHIMA has practice brief on retention
periods,
362
Retention & Destruction Updated
10/15/2013
363
Retention & Destruction
364
Federal and State Retention Periods
365
Surgical Procedures
320
Be performed in a safe manner,
By qualified practitioner with clinical
privileges,
What does safe manner mean?
The equipment and supplies are sufficient
so the type of surgery can be performed
safely,
Surgery dept must be organized and
staffed if you have one,
366
Surgical Procedures 2013
320
Standard: If a CAH provides surgical
services it must be performed in a safe
manner,
 By qualified practitioner with clinical privileges,
What does safe manner mean?
The equipment and supplies are sufficient
so the type of surgery can be performed
safely,
Surgery dept must be organized and staffed
if you have one,
367
Tag 320 Amended June 7, 2013
368
Surgical Services
320
 Must follow state and federal laws,
 Must follow standards of practice and
recommendations by national recognized
organizations (AMA, ACOS, APIC, AORN),
 Quality of outpatient surgical services must be
consistent with inpatient,
 Scope of surgical services must be writing and
approved by MS,
 OR must be supervised by experienced staff
member, address qualifications of supervisor of
OR rooms in P&P,
369
Surgical Procedures 320
If LPN or OR tech used as scrub nurses
then must be under RN who is immediately
available to physically intervene,
There are also a number of policies and
procedures that need to be in place.
AORN PeriOperative Standards and
Recommended Practices have many
resources to help meet CMS and TJC
requirements
 Must wear clean surgical attire that covers hair
370
Surgery Policies
320
 Aseptic surveillance and practice, including
scrub techniques
 Identification of infected and non-infected
cases
 Housekeeping requirements/procedures
 Patient care requirements
 Preoperative work-up
 Patient consents and releases
 Clinical procedures
 Safety practices

Patient identification procedures
371
Surgery Policies
320
 Duties of scrub and circulating nurse,
 Safety practices,
 The requirement to conduct surgical counts in
accordance with accepted standards of
practice,
 Scheduling of patients for surgery,
 Personnel policies unique to the OR,
 Resuscitative techniques,
 DNR status,
 Care of surgical specimens,
 Malignant hyperthermia,
372
Surgery Policies
320
 Appropriate protocols for all surgical
procedures performed. These may be
procedure-specific or general in nature and
will include a list of equipment, materials,
and supplies necessary to properly carry
out job assignments.
 Sterilization and disinfection procedures
 Acceptable operating room attire
 Handling infections and biomedical/medical
waste
373
H&P
320
Complete H&P must be done in
accordance with acceptable
standards of practice,
All or part may be delegated to other
practitioners (like PA or NP) if allowed
by your state law and CAH,
Surgeon must sign and assumes full
responsibility,
374
H&P
320
Need to have H&P on the chart
PRIOR to surgery,
An exception is an emergency and
then need brief admission note on
chart,
Note should include at a minimum
critical information about the patient’s
condition including pulmonary status,
cardiovascular status, BP, vital signs,
etc.
375
Informed Consent
320
This includes all inpatient and
outpatient,
Is informed of who will actually perform
the surgery (no ghost surgery),
Must inform patient if practitioner other
than the primary surgeon will perform
important parts of the surgical
procedure,
EVEN if it is under the primary surgeon’s
supervision,
376
Informed Consent
320
Consent must include:
Name of patient or their legal guardian,
Name of hospital (CAH),
Name of specific procedure,
Name of person doing the procedure or
important parts of the procedure other than
primary surgeon,
Significant surgical tasks include: opening and
closing, harvesting grafts, dissecting tissue,
removing tissue, implanting devices and altering
tissue,
377
Informed Consent 320
Nature and purpose of proposed treatment, Risks,
consequences if no treatment is rendered,
alternative procedures or treatments, probability that
proposed procedure would be successful
Signature of patient or guardian,
Date and time consent obtained,
Statement that procedure explained to the patient or
guardian,
Signature of professional person witnessing the
consent (proposal to change to only witness and
they are witness to signature only),
Name of person who explained procedure,
378
Informed Consent
320
Must disclose information to patient
necessary to make a decision,
It is a process and not a form,
Authorization form signed by a patient
who does not understand what he is
signing is not informed consent,
Given in language patient can
understand (interpreter and issue of
health care literacy),
379
PACU
320
Must be adequate provisions for immediate post-op
care,
Must be in accordance with acceptable standards of
care (ASPAN),
Separate room with limited access,
P&P specify transfer requirements to and from
PACU,
PACU assessment includes level of activity,
respiration, BP, LOC, patient color (aldrete),
If no PACU close observation by RN in patient’s
room,
380
OR Register
320
Register will include;
 Patient’s name, id number,
 Date of surgery,
 Total time of surgery,
 Name of surgeons, nursing personnel,
anesthesiologist,
 Type of anesthesia,
 Operative findings, preop and post-op
diagnosis, age of patient,
381
Operative Report Must Include
320
Name and id of patient,
Date and time of surgery,
Name of surgeons, assistants,
Pre-op and post-op dx,
Name of procedure,
Type of anesthesia,
Complications and description of techniques and
tissue removed,
Grafts, tissue, devises implanted,
Name and description of significant surgical tasks done by
others (see list-opening, closing, harvesting grafts,
382
Surveyor in OR
320
 Will verify access to OR and PACU is
limited,
 That there is appropriate cleaning between
surgical cases and appropriate terminal
cleaning applied;
 That operating room attire is suitable for
the kind of surgical case performed,
 That persons working in the operating
suite must wear only clean surgical
costumes,

AORN has a position statement on this
383
Surveyor in OR
320
That equipment is available for rapid and
routine sterilization of OR materials,
that equipment is monitored, inspected,
tested, and maintained by the CAH’S
biomedical equipment program,
sterilized materials are packaged, handled,
labeled, and stored in a manner that
ensures sterility e.g., in a moisture and dust
controlled environment,
P&P on expiration dates is followed,
384
Surveyor in OR 320
 OR organizational chart show lines of
authority and delegation within the dept,
 Make sure have the following:
 On-call system,
 Cardiac monitor,
 Resuscitator, Defibrillator, Aspirator
(suction equipment),
 Tracheotomy set (a cricothyroidotomy set
is not a substitute),
385
Surgical Privileges
321
Must designate who are allowed to perform
surgery,
Must conform to P&Ps,
must be within scope of practice laws,
Review the list of physician privileges to
determine if current,
Surgical privileges updated every 2 years,
Are procedures performed by appropriate
physicians,
386
Surgical Privileges
321
 Surgery service must maintain roster
specifying the surgical privilege,
 Current list of surgeons suspended must
also be retained,
 MS bylaws must have criteria for
determining privileges,
 Surveyor will review written assessment
of the practitioner's training, experience,
health status, and performance.
387
Surgical Privileges
321
Surgical privileges are granted in
accordance with the competence of
each,
MS appraisal procedure must evaluate
each practitioner’s training, education,
experience, and competence,
As established by the QI program,
credentialing, adherence to hospital P&P,
and laws,
388
Surgical Privileges
321
Must specify for each practitioner that
performs surgical tasks including MD, DO,
dentists, oral surgeon, podiatrists,
RNFA, NP, surgical PA, surgical tech et. al.,
Must be based on compliance with what
they are allowed to do under state law,
If task requires it to be under supervision of
MD/DO this means supervising doctor is
present in the same room working with the
patient,
389
390
Pre-Anesthesia Assessment 322
Pre-anesthesia evaluation must be
performed immediately prior to the
surgery,
By qualified person to administer
anesthetic to evaluate risk of anesthesia,
Must include; notation of risk of
anesthesia, anesthesia, drug, and allergy
history,
Potential anesthesia problems id,
Patient’s condition prior to induction,
391
Pre-anesthesia ASA Guideline
Preanesthesia Evaluation 1
 Patient interview to assess Medical history,
Anesthetic history, Medication history
Appropriate physical examination
Review of objective diagnostic data (e.g.,
laboratory, ECG, X-ray)
Assignment of ASA physical status
Formulation of the anesthetic plan and discussion
of the risks and benefits of the plan with the patient
or the patient’s legal representative
 1 www.asahq.org/publicationsAndServices/standards/03.pdf
392
ASA Guidelines and Standards
http://asahq.org/For-Healthcare-Professionals/StandardsGuidelines-and-Statements.aspx
393
394
ETCO2 for Moderate and Deep Sedation
ASA
http://asahq.org/For-Healthcare-Professionals/StandardsGuidelines-and-Statements.aspx
395
ASA Practice Advisory Preanesthesia
Evaluation
http://asahq.org/For-Members/Practice-Management/PracticeParameters.aspx
396
ASA Standard on Preanesthesia Care
http://asahq.org/For-Healthcare-Professionals/Standards-Guidelinesand-Statements.aspx
397
398
Post Anesthesia Evaluation 321
Post-anesthesia follow-up report must
be written on all inpatients and
outpatients prior to discharge,
Written by the individual who is qualified to
administer the anesthesia.
Must include at a minimum:
Cardiopulmonary status, LOC, follow-up
care and/or observations; and,
Any complications occurring during
PACU.
399
Post Anesthesia ASA Guidelines
Patient evaluation on admission and
discharge from the postanesthesia care unit
A time-based record of vital signs and level of
consciousness
A time-based record of drugs administered, their
dosage and route of administration
Type and amounts of intravenous fluids
administered, including blood and blood products
Any unusual events including post-anesthesia or
post procedural complications
Post-anesthesia visits
400
401
Anesthesia
323
CAH must designate who can administer
anesthesia,
MS include criteria for determining
privileges, In accordance with P&P and
scope of practice and state law,
Only by anesthesiologist, MD/DO, CRNA,
anesthesiology assistant, supervised trainee in
education program, dentist, podiatrist,
State exemption process of MD supervision for
CRNA,
402
Anesthesia
323
 A CRNA may administer anesthesia
when under the supervision of the
operating practitioner or of an
anesthesiologist who is immediately
available if needed,
 An anesthesiologist’s assistant (AA)
may administer anesthesia when
under the supervision of an
anesthesiologist who is immediately
available if needed.
403
Immediately Available Means
Physically located within the OR or in
the L&D unit;
and Is prepared to immediately conduct
hands-on intervention if needed;
and Is not engaged in activities that
could prevent the supervising
practitioner from being able to
immediately intervene and conduct
hands-on interventions if needed
404
Discharge
325
All patients are discharged in the
company of a responsible adult,
Any exceptions to this requirement
must be made by the attending
practitioner and documented in the
medical record,
Surveyor will verify that the CAH has
P&Ps in place to govern discharge
procedures and instructions,
405
Quality Assessment
331
Must periodically review total program (will
look at who is to do this),
At least once per year,
Include services provided and number of
patients served,
 look at volume of service (332),
Include at least 10% of charts- active and
closed charts (333),
406
Quality Assessment
335
Review all P&Ps also (show evidence
of how these are evaluated and
reviewed),
Purpose of the evaluation is to
determine whether the utilization of
services was appropriate,
And whether the P&P we revised if
needed,
407
Quality Assessment
336
An effective program includes;
Ongoing monitoring and data collection,
Problem prevention, id and analysis,
Identification of corrective actions,
Implementation of corrective actions,
Evaluation of corrective actions,
Measures to improve quality on a
continuous basis,
408
Quality Assessment
336
QA program to evaluate
appropriateness of diagnosis and
treatment and in treatment outcomes,
Facility wide QA program (QI),
Can have QA by arrangement,
Surveyor will look at your QI PLAN, QI
minutes,
409
Healthcare Associated Infections 337
Must evaluate nosocomial infections,
Must look at medication therapies,
Must evaluate the quality of care of LIPs (NP, PA,
CNS) by doctor on MS or under contract,
Will look at how their performance is evaluated
(339),
Quality of care and appropriateness of dx and tx
by doctors must be reviewed by QIO (PRO),
hospital that is member of network, or as identified
in state rural health plan (340),
410
Quality Improvement
341
Staff consider the findings and
evaluations and recommendations of the
evaluations and take corrective actions,
Take steps to remedial action to address
deficiencies found thru QI process,
Will look to see who is responsible for
implementing actions,
Document the outcomes of all remedial
actions (343)
411
340 Quality Assurance 7-15-2011
412
Quality Assurance 340
CAH have an arrangement for outside entity
to review the appropriateness of the
diagnosis and treatment provided by each
MD/DO providing services
 This includes doctors providing telemedicine
services
Some CAHs may also prefer to conduct their
own internal review in addition to the outside
review but not required
 Outside review may be done by hospital that is a member of the
same rural health network as the CAH; a Medicare QIO
413
Organ, Tissue, and Eye
344
Hospital must have written P&P to address
its organ procurement,
must have agreement with OPO,
Must timely notify OPO if death is imminent
or has patient has died,
OPO to determine medical suitability for
organ donation,
Defines what must be in your written
agreement (definitions, criteria for referral,
access to your death record information
414
OPO Agreements
415
Organ, Tissue, and Eye 345
Board must approve your organ procurement
policy,
Must integrate into hospital’s QAPI program,
Surveyor will review written agreement with
the OPO to make sure it has all the required
information,
Check off the long list to ensure all elements
are present (such as definition of imminent
death, what is timely notification, allows them
access to your death records etc.,
416
Imminent Death
345
Definition of imminent death might include a patient
with severe, acute brain injury who:
Requires mechanical ventilation (due to brain injury);
Is in an ICU or ED; AND
Has clinical findings consistent with a Glascow Coma Score
that is less than or equal to a mutually-agreed-upon
threshold; or
MD/DOs are evaluating a diagnosis of brain death (within 1
hour) ; or
An MD/DO has ordered that life sustaining therapies be
withdrawn, pursuant to the family’s decision (notify them
before withdrawing life sustaining therapies),
Make sure your staff is aware of the P&P,
417
Tissue and Eye Bank
346
Need an agreement with at least one
tissue and eye bank,
OPO is gatekeeper and notifies the
tissue or eye bank chosen by the
hospital,
OPO determines medical suitability,
Don’t need separate agreement with
tissue bank if agreement with OPO to
provide tissue and eye procurement,
418
Family Notification
347
Once OPO has selected a potential
donor, person’s family must be
informed of the donor’s family’s
option,
OPO and hospital will decide how
and by whom the family will be
approached,
419
Organ Donation
347
Person to initiate request must be a
designated requestor or organized
representative of tissue or eye bank,
Designated requestor must have completed
course approved by OPO,
Encourage discretion and sensitivity to the
circumstances, views and beliefs of the
families (348),
Surveyor will review complaint file for
relevant complaints,
420
Organ Donation Training
349
Patient care staff must be trained on
organ donation issues,
Training program at a minimum
should include: consent process,
importance of discretion, role of
designated requestor,
transplantation and donation, QI,
and role of OPO,
Train all new employees, when
change in P&P, and when problems
identified in QAPI process,
421
Organ Donation
349
Hospital must cooperate with OPO to review
death records to improve id of potential
donors,
Surveyor will verify P&P that hospital works
with OPO,
Maintain potential donors while necessary
testing and placement of donated organs
take place,
Must have P&P to maintain viability of
organs,
422
Swing Beds LTC Services
350-408
Must meet following to provide posthospital SNF care (350),
Must be certified by CMS,
SNF services must be in compliance with
Subpart B of part 483,
Allows CAH to use beds interchangeable
for either acute care or SNF level,
Swings from acute care reimbursement to
SNF services and reimbursement,
423
Swing Beds
Must be discharge orders from acute care,
progress notes and discharge summary
and subsequent admission orders,
If patient does not change facilities can use
same MR with chart separator,
Medicare requires 3 day qualifying stay in
CAH prior to admission to swing bed,
3 day rule only applies to Medicare
patients,
424
Swing Beds
No LOS restriction for swing bed,
No transfer agreement needed
between CAH and nursing home,
CAH does not have to use the MDS
form for recording patient assessment,
Swing bed patients receive SNF level
of care and CAH is reimbursed for
SNF level.
425
Swing Beds-Requirements
Resident rights,
Admission, transfer, and discharge
rights,
Resident behavior and family practices
(restraints),
Patient activities,
Social services, comprehensive
assessment, dental services, and
nutrition,
426
Eligibility
351
Must be certified as CAH,
Have no more than 25 beds,
Section on facilities participating as
rural health care hospital (see 352),
Have to be in compliance with SNF
requirements in subpart B of part 483,
(residents rights, nutrition, dental,
admission and discharge rights, patient
activities, social services, comprehensive
assessment etc.,
427
Resident Rights
361
Right to dignified existence,
Self determination,
Communicate and access to
persons and services outside the
facility,
Right to a copy of a notice of their
rights,
In language they can understand,
Right to refuse treatment,
428
Resident Rights
361
Right to get access to their records within
24 hours (excluding weekends/holidays),
A right to buy a copy of their medical
records with 2 working days notice,
Rights in writing about their conduct and
responsibilities during their stay,
Facility must assure patient’s rights are
followed,
Right to know what their rights are,
429
Resident Rights
361
Right to choose attending MD,
Right to share room with their spouse,
Participate in their plan of care,
Right to privacy and confidentiality,
Right to get mail and send mail unopened,
Right to personal property and visitors,
Work or not work,
Provide interpreters, sign language when
needed,
430
Resident Rights
362
Right to refuse treatment,
Right to refuse to participate in
experimental research,
A resident being considered for
participation in experimental research
must be fully informed of the nature of the
experiment and understand the possible
consequences of participating,
Will look to see if IRB has approved
experimental treatment,
Right to make an advance directive,
431
Resident Rights
363
 Inform each Medicaid patient that items and
services that will be included and for which the
resident will be charged and amount,
 If M/M does not make payment for service, must
notify the resident of what is not covered,
 May charge for phone, TV, radio, personal
clothing, confections, flowers, plants, private room
unless isolation, social events, books etc.,
 Must have P&P for advance directives, educate
your staff on advance directives,
 Must document in the MR if they have one,
 Provide for community education on advance
directives (can use videotapes and audiotapes),
432
Free Choice
364
Right to choose an attending MD/DO,
But doctor must fulfill given
requirements such as the frequency of
visits,
Facility has right to inform resident to
seek another doctor,
Facility must help patient to find
another physician,
433
Consent
365
 Right to be fully informed in advance about care
and treatment,
 Including any changes,
 They have right to receive information in order to
make healthcare decisions,
 information should include medical condition,
changes in condition, the benefits, reasonable
risks of the recommended treatment, and
reasonable alternatives,
 Financial costs to treatment options must be
disclosed in advance and in writing,
434
Privacy/Confidentiality
367
Right to personal privacy,
Right to confidentiality,
Privacy to written and telephone calls,
Right to privacy for visits in office, dining
room, vacant chapel,
Privacy when using bathroom,
Staff should pull curtains, close doors,
435
Work
368
 Resident has right to refuse to perform services
for the facility,
 Perform services if she wants (housekeeping,
laundry, meal preparation),
 Document need or desire to work in the plan of
care,
 Specify if services performed are paid or
voluntary,
 Rate must be at prevailing rate, laundry
436
Mail
369
Right to send and promptly receive
mail that is unopened; and
Have access to stationery, postage,
and writing implements at the
resident’s own expense.
Deliver mail within 24 hours of delivery
by us post office,
437
Access and Visitation
370
The resident has the right and the facility
must provide immediate access to any
resident by the following,
immediate family or other relatives of the
resident,
others who are visiting with the consent of
the resident.
Resident can withdrawal consent at any
time,
438
Personal Property
371
Right to retain and use personal
possessions,
Including some furnishings, and
appropriate clothing, as space permits,
 Unless to do so would infringe upon the
rights or health and safety of other
residents,
Surveyor will look to see if residents are
encouraged to have and use personal
items,
439
Married Couples
372
Resident has the right to share a
room with his or her spouse,
 When married residents live in the
same facility,
And both spouses consent to the
arrangement.
If there is a room available,
440
Admission, Transfers, Discharge
Transfer means outside of the facility,
Purpose to restrict transfer by facility-to prevent
dumping of high care or difficult residents (373),
Only when initiated by the facility not the patient,
May not transfer or discharge a resident unless
necessary to meet their welfare,
Appropriate because no longer needs the
services provided (374),
Safety or health of individuals in facility is
endangered,
441
Admission, Transfers, Discharge
Must document these in the medical
record,
Must notify resident and family members
and document reasons,
30 days notice with
exceptions,endangerment to others,
condition improved, urgent medical
needs to be transferred,
Not a resident for 30 days,
442
Payment of Care 375
Resident has failed to pay for care after reasonable
notice,
If eligible for Medicare after admission, may only
charge allowable rate,
Must provide notice to the patient and document
reason in MR (377),
Must be made within 30 days before resident is
transferred, unless safety or health of individuals
would be in danger,
Need to document accurate assessments to
address resident’s needs,
443
Resident Behavior-Restraints
Right to be free from restraints (381),
Both physical and chemical,
Must do assessment and care planning,
Never used for discipline or convenience,
Need to have process of assessment and
evaluation before restraints used,
Include in the plan of care,
444
Abuse 382
Right to be free from verbal, sexual, physical, and
mental abuse,
Free from involuntary seclusion,
Defines each of these,
Must have written policies that prohibit neglect, and
abuse and mistreatment,
include the definitions of each in your policy,
Will review any records of abuse,
Need P&P that prohibit mistreatment, neglect, and
abuse and misappropriation of resident property,
445
Hiring of Employees 384
Not hire if found guilty of abusing, neglecting, or
mistreating residents by a court of law,
Or entered into state NA registry for this,
Report any alleged violation involving neglect or
abuse, or misappropriation of property to
administrator and to other officials as required by
state law,
Must investigate,
Should check all references,
446
Surveyor will look at….
384
Was relevant documentation reviewed and
preserved (e.g., dated dressing which was
not changed when treatment recorded
change)?
Was the alleged victim examined promptly (if
injury was suspected) and the finding
documented in the report?
What steps were taken to protect the alleged
victim from further abuse (particularly
where no suspect has been identified)?
447
Surveyor Will Look At
What actions were taken as a result of
the investigation?
What corrective action was taken,
including informing the nurse aide
registry, State licensure authorities,
and other agencies (e.g., LTC
ombudsman; adult protective
services; Medicaid fraud and abuse
unit)?
448
Quality of Life
Must care for residents in way that
promotes quality of life,
Have activities directed by qualified
person,
Qualified occupational therapist,
Must provide social services to attain
physical, mental and psychosocial well
being,
449
Activities
385
 Facility must provide for an ongoing program of
activities designed the interests and the physical,
mental, and psychosocial well-being of each
resident.
 Activities program by a qualified therapeutic
recreation specialist or activity professional who
is licensed or registered by state,
 Or 2 yr experience on social or recreational
program within the last 5 years, or
 Is qualified OT or OT assistant,
 Or had completed training by the state,
450
Activities
385
 Surveyor will observe individual
and group activity,
 Long list of things under the
survey procedures on this one,
 What activities are planned,
 Outcomes and responses,
 Included in care plans based on
resident’s assessment,
 Adequate supplies,
451
Social Services
386
 Facility must provide medically-related social
services to attain or maintain the highest
practicable physical, mental, and psychosocial
well-being of each resident,
 Need bachelor’s degree in social work or human
services field (psychology, rehab counseling,
etc.) and 1 year supervised social work
experience in health care setting,
452
Social Services
386
Making arrangements for obtaining needed adaptive
equipment, clothing, and personal items;
Maintaining contact with family (with resident’s
permission) to report on changes in health,
current goals, discharge planning, and
encouragement to participate in care planning;
Assisting staff to inform residents and those they
designate about the resident’s health status and
health care choices;
Making referrals and obtaining services from outside
entities (e.g., talking books, absentee ballots,
community wheelchair transportation);
453
Social Services 386
Assisting residents with financial and legal
matters (e.g., applying for pensions,
referrals to lawyers, referrals to funeral
homes for preplanning arrangements);
Discharge planning services (e.g., helping to
place a resident on a waiting list for
community congregate living, arranging
intake for home care services for residents
returning home, assisting with transfer
arrangements to other facilities);
Providing or arranging provision of needed
counseling services;
454
Resident Assessments 388
Conduct initial and periodic and reproducible
assessments of each resident’s functional
capacity, and includes;
Identification and demographic
information.
 Customary routine.
 Cognitive patterns.
 Communication.
 Vision.
 Mood and behavior patterns.
 Psychosocial well-being.
455
Resident Assessments 388
 Physical functioning and structural
problems.
 Continence.
 Disease diagnoses and health
conditions.
 Dental and nutritional status.
 Skin condition.
 Activity pursuit.
 Medications
456
Resident Assessments 388
 Special treatments and procedures.
 Discharge potential.
 Documentation of summary information
regarding the additional assessment
performed through the resident
assessment protocols.
 Documentation of participation in
assessment.
 Must do direct observation and communicate
with resident and licensed members on all shifts,
 Intent to do this to develop care plan,
457
Assessments
Assessment within 14 days after admission,
Assessment if significant change (390),
Excludes readmissions if no significant change in
condition (389),
Very detailed information on what constitutes a
significant change (394),
Must have a comprehensive care plan (395),
Care plan must include measurable objectives to
met patient’s needs,
458
Care Plans
395
 Interdisciplinary team should develop objectives
to attain highest level of functioning,
 Document if patient refuses something staff feel
would help,
 Care plan must be developed within 7 days after
comprehensive assessment done,
 Prepared by interdisciplinary team that includes
doctor, RN with responsibility for resident,
resident and family,
 Review and revise as necessary,
459
Care Plan
395
 Did an occupational therapist design needed
adaptive equipment or a speech therapist provide
techniques to improve swallowing ability?
 Do the dietitian and the speech therapist determine,
for example, the optimum textures and consistency
for the resident’s food that provide both a
nutritionally adequate diet and effectively use
oropharyngeal capabilities of the resident,
 Does staff make an effort to schedule care plan
meetings at the best time of the day for residents
and their families?
460
Service Provided
397
 Services provided must meet the standard
of care,
 Make sure person providing care are
qualified,
 Are residents with acute conditions promptly
hospitalized, as appropriate?
 Are there errors in medication
administration?
 Make sure they follow the care plan (399),
461
Discharge Summary
399
Resident must have a discharge summary
that includes;
Recapitulation of the resident’s stay,
Final summary of the resident’s status,
A post-discharge plan of care that is
developed with the participation of the
resident and his or her family, which will assist
the resident to adjust to his or her new living
environment.
462
Nutrition
400
The facility must ensure that a resident;
Maintains acceptable parameters of
nutritional status, such as body weight and
protein levels,
unless the resident’s clinical condition
demonstrates that this is not possible,
Unacceptable parameters include
unplanned weight loss, peripheral edema,
cachexia and laboratory tests indicating
malnourishment (e.g., serum albumin
levels).
463
Nutrition 401
Suggested
parameters for
evaluating
significance of
unplanned and
undesired weight
loss are:
See detailed
information under
401,
Interval
Significant
Loss
Severe Loss
1 month
5%
Greater than 5%
3 months
7.5%
Greater than
7.5%
6 months
10%
Greater than
10%
464
Suggested Laboratory Values
 Albumin >60 yr.: 3.4 - 4.8 g/dl (good for
examining marginal protein depletion),
 Plasma Transferrin >60 yr.:180 - 380 g/dl.
(Rises with iron deficiency anemia. More
persistent indicator of protein status.),
 Hemoglobin 14-17 males and 12-15 females,
 Hemocrit
males 41-53, females 36-46,
 K+ 3.5-5.0,
 Mg+ 1.3-2.0,
465
Rehab Services
402
If specialized rehabilitative services such
as, but not limited to,
physical therapy, speech-language
pathology, occupational therapy, and
mental health rehabilitative services for
mental illness and mental retardation,
are required in the resident’s
comprehensive plan of care,
Facility must provide the required
service,
466
Rehab Services 402
Need physician order (403)
May get from outside source,
No fee can be charged a Medicaid
recipient for specialized
rehabilitative services because they
are covered facility services.
467
Occupational Therapy
402
 What did the facility do to decrease the
amount of assistance needed to perform a
task?
 What did the facility do to decrease
behavioral symptoms?
 What did the facility do to improve gross and
fine motor coordination?
 What did the facility do to improve sensory
awareness, visual-spatial awareness, and
body integration?
 What did the facility do to improve memory,
problem solving, attention span, and the
ability to recognize safety hazards?
468
Speech, Language Pathology
 What did the facility do to improve auditory
comprehension?
 What did the facility do to improve speech
production and expressive behavior?
 What did the facility do to improve the
functional abilities of residents with moderate to
severe hearing loss who have received an
audiology evaluation?
 For the resident who cannot speak, did the
facility assess for a communication board or an
alternate means of communication?
469
Dental Services
404
The facility must assist residents in
obtaining routine and 24-hour emergency
dental care.
This requirement makes the facility directly
responsible for the dental care needs of its
residents.
The facility must ensure that a dentist is
available for residents,
 Make appt and arrange transportation (408),
 Can’t charge Medicaid patients,
 For Medicare and private pay can impose
additional charge,
470
AHA Website on CAH
www.aha.org/memberRelations/cah.asp
Provides updates,
Directory of resources,
Federal legislation,
Growth of the program,
Grants,
State hospital association links,
471
 Statement of Deficiencies and Plan of
corrections,
Based on documentation of surveyor
worksheet or notes and form CMS-2567,
472
473
The End! Questions??
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
474
474
The End
Are you up to the
challenge??
 See additional
resources including
patient safety resources,
475
Websites
Tools and Resources Rural Health
Resource Center at
http://www.ruralcenter.org/tasc/
 American Association for Respiratory
Care AARC- www.aarc.org,
American College of Surgeons ACSwww.facs.org,
American Nurses Association ANAwww.ana.org
476
Websites
 Center for Disease Control CDC –
www.cdc.gov,
 Food and Drug Administration- www.fda.gov,
 Association of periOperative Registered
Nurses at AORN- www.aorn.org,
 American Institute of Architects AIAwww.aia.org,
 Occupational Safety and Health Administration
OSHA – www.osha.gov,
 National Institutes of Health NIH-www.nih.gov,
477
Websites
 United States Dept of Agriculture USDAwww.usda.gov,
 Emergency Nurses Association ENAwww.ena.org,
 American College of Emergency Physicians
ACEP- www.acep.org,
 Joint Commission Joint Commissionwww.JointCommission.org,
 Centers for Medicare and Medicaid Services
CMS- www.cms.hhs.gov,
478
Websites
 American Association for Respiratory
Care AARC- www.aarc.org,
American College of Surgeons ACSwww.facs.org,
American Nurses Association ANAwww.ana.org,
AHRQ is www.ahrq.gov,
479
Websites
 American Hospital Association AHAwww.aha.org,
 CMS Life Safety Code page http://new.cms.hhs.gov/CFCsAndCoPs/07_
LSC.asp,
 COPs available in word and PDR at
http://www.access.gpo.gov/nara/cfr/waisidx
_04/42cfr485_04.html,
 American College of Radiologywww.acr.org,
480
Websites
 Federal Emergency Management Agency
(FEMA)- www.fema.gov,
 Drug Enforcement Administration –
www.dea.gov (copy of controlled substance
act),
 US Pharmacopeia- www.usp.org, (USP 797
book for sale),
 Rural Assistance Center or RAC at
http://www.raconline.org/
 CAH seminar Oct 2007 handouts at
http://www.nrharural.org/conferences/sub/CAH.
html
481
Websites
 National Patient Safety Foundation at the AMAwww.ama-assn.org/med-sci/npsf/htm,
 The Institute for Safe Medication Practiceswww.ismp.org
 U.S. Pharmacopeia (USP) Convention, Inc.www.usp.org
 U.S. Food and Drug Administration MedWatchwww.fda.gov/medwatch
 Institute for Healthcare Improvement- www.ihi.org,
 AHRQ at www.ahrq.gov,
 Sentinel event alerts at www.jointcommission.org,
482
Websites
 American Pharmaceutical Associationwww.aphanet.org
 American Society of Heath-System Pharmacistswww.ashp.org
 Enhancing Patient Safety and Errors in Healthcarewww.mederrors.com
 National Coordinating Council for Medication Error
Reporting and Prevention-www.nccmerp.org,
 FDA's Recalls, Market Withdrawals and Safety Alerts
Page: http://www.fda.gov/opacom/7alerts.html
483
Infection Control Websites
 Association for Professionals in Infection Control and
Epidemiology (APIC) infection control guidelines at
www.apic.org,
 Centers for Disease Control and Preventionwww.cdc.gov,
 Occupational Health and Safety Administration
(OSHA) at www.osha.gov,
 The National Institute for Occupational Safety and
Health NIOSH at www.cdc.gov/niosh/homepage.html,
 AORN at www.aorn.org,
 Society for Healthcare Epidemiology of America
(SHEA) at www.shea-online.org,
484
www.flexmonitoring.org/links.shtml
485
Helpful Websites
486
487
Federal Office of Rural Health Policy
Federal Office or Rural Health Policy
Room 9A-55
5600 Fishers Lane
Rockville, MD 20857
301 443-0835
301 443-2803 fax
488
Office of Rural Health Policy
Advises DHHS on matters affecting rural
hospitals,
Has resources for CAH,
Furnishes selected articles,
 Articles on rural issues on their web site
http://www.ruralhealth.hrsa.gov/index.htm
489
490
491
Physical Environment
How do you provide emergency power?
Can emergency generator provide power for
emergency equipment and lighting,
Review maintenance records and policies of test
runs and how often on emergency equipment,
492
Resources
 AHRQ published patient safety primer in
2008 that is designed to help users to
understand key concepts in patient safety
at http://psnet.ahrq.gov/primerHome.aspx,
TeamSTEPPS is a teamwork system with
tons of free resources on this at
http://teamstepps.ahrq.gov/
493
AHRQ Website
http://www.ahrq.gov/qual/
494
IHI Website
www.ihi.org/ihi
495
SafetyLeaders.org Website
496
AHA Quality Center
http://www.ahaqualitycenter.org/ahaqualitycenter/jsp/home.jsp
497
NCP VA National Safety for Patient Safety
Has multiple resources available at
www.patientsafety.gov/bravo.htm
TIPS Newsletter - topics concerning patient safety,
NCPS Patient Safety Handbook developed by the
National Center for Patient Safety,
Fall incident report by Morse Fall Scale and tools for
falls,
Patient elopement tools,
Medication tips,
498
499
AHRQ
Medical Error and Patient Safety at
http://www.ahrq.gov/qual/errorsix.htm, Web
M&M, Mortality and Morbidity Monthly, at
http://www.webmm.ahrq.gov/,
PSNet, AHRQ Patient Safety Network,
http://psnet.ahrq.gov/, contains articles on
medication errors and other patient safety
issues that come out,
Are you signed up to get this? You can
browse under medication errors/ADE
500
topic.(866 articles)
501
ISMP
 Institute for Safe Medication Practice is a rich
source of information,
 www.ismp.org,
 Has medication tools and resources,
 Has high alert list, self assessment tools
 Error prone abbreviation,
 FDA MedWatch,
 Confused drug name list, anticoagulant safety,
 Sign up nurses for free newsletter via email called
Nurse Advise-ERR at
https://www.ismp.org/orderforms/adviseERRsubscri
502
ption.asp
503
USP US Pharmacopeia
 Good source of information and have
the MEDMARX program,
 Have drug error finder for LASA,
 Revises heparin monograph at
http://www.usp.org/hottopics/heparin.ht
ml?hlc.
 Has newletters at
http://www.usp.org/aboutUSP/newslett
er.html
 Has USP email notices –monthly
updates,
 www.usp.org
504
505
Sign Up for FDA Alerts
 Sign up to get safety alerts from FDA,
 At http://www.fda.gov/opacom/7alerts.html
 Example; Advil and ASA taken together- if heart
patient takes ASA 81 mg for heart- ibuprofen can
interfere with anti-platelet effect,
 Take 30 minutes or longer,
 Minimal risk with occasional use,
 Lots of information on medications!
 See also Drug Safety newsletter at
http://www.fda.gov/cder/dsn/2008_winter/2008_wint
er.pdf
506
507
FDA Patient Safety News 2008
Mixups between insulin U-100 and U-500
which occurred when selecting from
computer screens,
Severe pain, muscle or joint pain, with
osteoporosis drug with bisphosphate drugs
such as Fosamax, Actonel, Boniva, and
Reclast,
More patients die with luer misconnections,
Deaths from Fentanyl patches continue,
 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
508
509
IHI Institute for Healthcare Improvement
Excellent source of resources for patient
safety and quality resources, toolkits, how to
kits,
Prevent ADEs by implementing medication
reconciliation,
Reduce harm from high alert medications,
Reduce MRSA infections,
Many resources related to medication
issues, At www.ihi.org,
510
511
Leapfrog
Represents half a million Americans by
corporations that purchase health insurance,
Rewards for improving safety and quality,
Aims CPOE, 27 procedures to preventing
medical errors, high risk treatments, ICU
staffing with intensivists
If 3 followed would prevent 907,600
medication errors, 65,341 lives and $41
billion dollars a year!
www.leapfroggroup.org
512
National Quality Forum
30 Safe Practices published in October, 2006,
34 Safe Practices Update 2009,
Includes CPOE, unit dose, anticoagulant
therapy, culture of safety, standardize labeling
and storage of medication, identification of
high alert medications, medication
reconciliation,
 Chapter 6 was on Medication Management,
513
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
CHAPTER 2: Creating and Sustaining a Culture of
Patient Safety
• Leadership Structures & Systems
• Culture Measurement, Feedback and Interventions
• Teamwork Training and Team Interventions
• Identification and Mitigation of Risks and Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Order
Read-back
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
CHAPTER 5: Information Management & Continuity of
Care
• Critical Care Information
• Order Read-back
• Labeling Studies
• Discharge Systems
• Safe Adoption of Integrated Clinical Systems
including CPOE
• Abbreviations
CHAPTER 6: Medication Management
• Pharmacist Role
Medication Management
• Medication Reconciliation
.
• High-Alert Medications
• Standardized Medication Labeling & Packaging
• Unit-Dose Medications
Hospital Acquired Infections
Labeling
Studies
Discharge
System
CPOE
Abbreviations
Med Recon
Pharmacist
Central Role
High Alert
Meds
Std. Med
Labeling & Pkg
Unit Dose
Medications
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 6: Medication Management
• Medication Reconciliation
• Pharmacist Role
• Standardized Medication Labeling & Packaging
• High-Alert Medications
• Unit-Dose Medications
CHAPTER 7: Hospital-Acquired Infections
• Prevention of Aspiration and VentilatorAssociated Pneumonia
• Central Venous Catheter-Related Blood Stream
Infection Prevention
• Surgical Site Infection Prevention
• Hand Hygiene
• Influenza Prevention
CHAPTER 8:
• Evidence-Based Referrals
• Wrong-Site, Wrong Procedure, Wrong Person
Surgery Prevention
• Perioperative Myocardial Infarct/Ischemia
Prevention
• Pressure Ulcer Prevention
• DVT/VTE Prevention
• Anticoagulation Therapy
• Contrast Media-Induced Renal Failure Prevention
514
Pa Patient Safety Authority
www.psa.state.pa.us/psa/site/default.asp
515
Federal Office of Rural Health Policy
Federal Office or Rural Health Policy
Room 9A-55
5600 Fishers Lane
Rockville, MD 20857
301 443-0835
301 443-2803 fax
516
Office of Rural Health Policy
Advises DHHS on matters affecting rural
hospitals,
Has resources for CAH,
Furnishes selected articles,
 Articles on rural issues on their web site
http://www.ruralhealth.hrsa.gov/index.htm
517
518
519
The End!
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
President
Chief Learning Officer
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
520
520