Transcript Dill-presentation-CMS-2016-HOSPITAL-COP-PART-ALL-DAY

CMS HOSPITAL CONDITIONS OF
PARTICIPATION (COPS) 2015
All Day Program
What PPS Hospitals Need to Know
Speaker
 Sue Dill Calloway RN, MSN, Esq.
CPHRM, CCMSCP
 AD, BA, BSN, MSN, JD
 President of Patient Safety and
Education Consulting
 5447 Fawnbrook Lane
 Dublin, Ohio 43017
 614 791-1468 (Call with questions, no emails)
 [email protected]
2
You Don’t Want One of These
3
The Conditions of Participation (CoPs)
 Many revisions since manual published in 1986
 Manual updated more frequently now
 First regulations are published in the Federal
Register then CMS publishes the
Interpretive Guidelines and some have
survey procedures 2
 Hospitals should check this website once a month
for changes
1 http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR
2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp
4
Subscribe to the Federal Register
http://listserv.access.gp
o.gov/cgibin/wa.exe?SUBED1=
FEDREGTOC-L&A=1
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CMS Survey and Certification Website
www.cms.gov/SurveyCertific
ationGenInfo/PMSR/list.asp#
TopOfPage
Click on Policy & Memos
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Example of Survey Memo Glucose Monitoring
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CMS Changes Phase II
 In final rule, CMS estimates cost safety to be nearly
$660 million annually or $3.2 billion over five years
 The name of the federal rule was “Medicare and Medicaid
Programs; Regulatory Provisions to Promote Program
Efficiency, Transparency, and Burden Reduction; Part II”
 The final rule was 201 pages long and effective July 11,
2014 and two final IG memos issued
– MS and Board section memo issued Sept 15, 2014
rest issued January 30, 2015 and in April 1, 2015
manual
 CMS also rewrites all the radiology and nuclear
medicine sections in July, 2015
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Board and Medical Staff Final IGs
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IG for Final Rules OP, NM, Dietary etc.
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Radiology and Nuclear Medicine
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Changes to Hospital Sections II
 Governing Body (§ 482.12)
 Medical Staff (§ 482.22)
 Food and Dietetic Services (§ 482.28)
 Nuclear Medicine Services (§ 482.53)
 Outpatient Services (§ 482.54)
 Special Requirements for Hospital Providers of
Long-term Care Services (“swing-beds”) (§
482.66)
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Summary of Changes
 Medical Staff (MS) can grant hospital privileges for
RD or nutrition specialist to write diet orders
 Includes diet orders, TPN, or supplemental feeding
 Board must consult with and individual responsible
for the MS for each individual hospital regarding
quality of medical care provided in the hospital and
suggest at least twice a year
 Such as the chief medical officer or MS president
 Each hospital can have separate medical staff or
shared which CMS calls a unified integrated medical
staff with specific rules in a multi hospital system
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Summary of Changes
Allow in-house preparation of
radiopharmaceuticals by trained nuclear
medicine technicians in hospitals on off hours
without a physician or a pharmacist being
present
Medical Staff can include PharmD,
registered dieticians, PA, NP, dentist,
podiatrist, speech pathologist, etc.
 Must be consistent with state scope of
practice and state law
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Summary of Changes
 Allow practitioners not on MS to order outpatient
services
 Must have policy to specify which tests can be
ordered
 Must be licensed in state where care is provided
 Must be acting within scope of practice under state
law
 Must be allowed by the MS
 Confirms its prior interpretation regarding who can
order outpatient orders under tag 1079 and 1080
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Summary of Changes
Made a change to the CLIA law regarding
proficiency testing referrals
Swing beds move to Part D so accreditation
organizations
 TJC, AOA HCFA, DNV Healthcare or CIHQ
Questions contact Lauren Oviatt at 410 7864683 at CMS
Email questions to
[email protected]
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How to Keep Up with Changes
First, periodically check to see you have the
most current CoP manual1
Once a month go out and check the survey
and certification website
2
Once a month check the CMS transmittal
page
3
Have one person in your facility who has this
responsibility

1

2 http://www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage

3 http://www.cms.gov/Transmittals
http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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Location of CMS Hospital CoP Manual
New website
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
19
Called the State Operations Manual SOM
www.cms.hhs.gov/manual
s/downloads/som107_Ap
pendixtoc.pdf
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Transmittals
www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/2015-Transmittals.html
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CMS Survey Memos
 CMS has many recent memos of interest
 Privacy and confidentiality 3 Ebola memos
 Luer misconnections, IV and blood and blood products
 Use of insulin pens issue, immediate use steam sterilization
 Single dose vials and safe injection practices
 2 memos on Humidity in the OR, Reporting to internal PI
program, Radiology and Nuclear Medicine
 Complaint manual and reporting to AO
 Deficiencies of hospitals,
 OPO,
Equipment Maintenance
Medication and Safe Opioid Use
 Three worksheets finalized, Glucose Monitoring
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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
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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
27
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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New Standards Prevent Tubing Misconnections
 New and unique international standards being
developed for connectors for gas and liquid delivery
systems
 To make it impossible to connect unrelated systems
 Includes new connectors for enteral, respiratory,
limb cuff inflation neuraxial, and intravascular
systems
 Phase in period for product development, market
release and implementation guided by the FDA and
national organizations and state legislatures
 FAQ on small bore connector initiative
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www.premierinc.com/tubingmisconnections/
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Managing Risk During the Transition
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Misconnections & How to Prepare
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CMS Hospital Worksheets History
 October 14, 2011 CMS issues a 137 page memo in the
survey and certification section and it was pilot tested in
hospitals in 11 states
 Memo discusses surveyor worksheets for hospitals by CMS
during a hospital survey
 Addresses discharge planning, infection control, and
QAPI (quality improvement performance improvement)
 May 18, 2012 CMS published a second revised edition and
pilot tested each of the 3 in every state over summer 2012
 November 9, 2012 CMS issued the third revised worksheet
 Final ones issued November 26, 2014
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Final 3 Worksheets QAPI
www.cms.gov/SurveyCertificationG
enInfo/PMSR/list.asp#TopOfPage
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CMS Hospital Worksheets
 Hospitals should be familiar with the three
worksheets
 Will use whenever a validation survey or
certification survey is done at a hospital by CMS
 CMS says worksheets are used by State and
federal surveyors on all survey activity in
assessing compliance with any of the three CoPs
 Hospitals are encouraged by CMS to use the
worksheet as part of their self assessment tools
which can help promote quality and patient safety
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CMS Hospital Worksheets
 And of course completing the forms helps the
hospital to comply with those three CoPs
 Citation instructions are provided on each of the
worksheets
 The surveyors will follow standard procedures when
non-compliance is identified in hospitals
 This includes documentation on the Form CMS
2567
 Not used in CAH but good tool for CAH to use
 Questions to: [email protected]
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CMS Hospital Worksheets
 Some of the questions asked might not be apparent
from a reading of the CoPs
 So the worksheets are a good communication
device
 It helps to clearly communicate to hospitals what is
going to be asked in these 3 important areas
 Hospitals might want to consider putting together a
team to review the 3 worksheets and complete the
form in advance as a self assessment
 Hospitals should consider attaching the
documentation and P&P to the worksheet
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CMS Memo on Safe Injection Practices
 Bottom line is you can not use a single dose vial on
multiple patients
 Section in IC worksheet on safe injection practices
 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/Practice
Tools/SterileProductsTool.aspx
 Click on starting using sterile products outsourcing tool
now
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www.ashpfoundation.org/MainMenuCategories/Practice
Tools/SterileProductsTool.aspx
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Safe Injection Practices www.empsf.org
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Not All Vials Are Created Equal
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Watch Award Winning Video
Safe Injection Practices - How to Do It Right
www.youtube.com/watch?v=6D0stMoz80k&feature=youtu.b
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ISMP IV Push Medications Guidelines
 ISMP has published a 26 page document called
“ISMP Safe Practice Guidelines for Adult IV Push
Medications
 The document is organized into factors that
increase the risk of IV push medications in adults,
 Current practices with IV injectible medications
 Developing consensus guidelines for adult IV push
medication and
 Safe practice guidelines
 About 90% of all hospitalized patients have some form of
infusion therapy
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IV Push Medicine Guidelines
Remember; CMS says you have to follow
standards of care and specifically mentions the
ISMP so surveyor can site you if you do not
follow this.
46
IV Push Medications Guidelines
 Provide IV push medications in a ready to
administer form
 Use only commercially available or pharmacy
prepared prefilled syringes of IV solutions to flush
and lock vascular access devices
 If available in a single dose vial then need to buy in
single dose vial
 Aseptic technique should be used when preparing
and administering IV medication
 This includes hand hygiene before and after
administration
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IV Push Medications Guidelines
 The diaphragm on the vial should be disinfected
even if newly opened
 The top should be cleaned using friction and a sterile 70%
isopropyl alcohol, ethyl alcohol, iodophor, or other
approved antiseptic swab for at least ten seconds to it dr
 Medication from a glass vial should be with a filter
needle unless the specific drug precludes this
 Medication should only be diluted when
recommended by the manufacturer or in
accordance with evidence based practice or
approved hospital policies
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IV Push Medications Guidelines
 If IV push medication needs to be diluted or
reconstituted these should be performed in a clean,
uncluttered, and separate location
 Medication should not be withdrawn from a
commercially available, cartridge type syringe into
another syringe for administration
 It is also important that medication not be drawn up
into the commercially prepared and prefilled 0.9%
saline flushes
 This are to flush an IV line and are not approved to use to
dilute medication
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CMS Memo May 30, 2014
 CMS publishes 4 page memo on infection control
breaches and when they warrant referral to the
public health authorities
 This includes a finding by the state agency (SA),
like the Department of Health, or an accreditation
organization
 TJC, DNV Healthcare, CIHQ, or AOA HFAP
 CMS has a list and any breaches should be referred
 Referral is to the state authority such as the state
epidemiologist or State HAI Prevention Coordinator
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Infection Control Breaches
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CMS Memo Infection Control Breaches
If any of the listed breaches are observed,
then will take appropriate enforcement action
 And will make the public health authority aware
 Includes LTC, ASCs, hospice, hospitals, home
health agencies, CAH, rural health clinics and
dialysis facilities
 CDC is working closely with SA on HAI
prevention
List of breaches to be referred include:
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CMS Memo Infection Control Breaches
 Using the same needle for more than one individual;
 Using the same (pre-filled/manufactured/insulin or
any other) syringe, pen or injection device for more
than one individual
 Re-using a needle or syringe which has already
been used to administer medication to an individual
to subsequently enter a medication container (e.g.,
vial, bag), and then using contents from that
medication container for another individual
 Using the same lancing/fingerstick device for more
than one individual, even if the lancet is changed
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3 EBOLA Memos Issued
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CRE and ERCP’s
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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
 Updating quarterly
 Available under downloads on the hospital website at www.cms.gov
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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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Can Count the Deficiencies by Tag Number
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Lists by State and Names Hospitals
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Complaint Manual Update
 CMS issues memo on April 19, 2013
 CMS updates the Complaint Manual
 Hospital found to be in immediate jeopardy could
have a full validation survey if the RO requests it
 Regional office has discretion
 GAO emphasized need to share complaint
information and SA survey finding with the
applicable accreditation agency and CMS
agrees
 TJC, DNV,AOA, or CIHQ
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Complaint Manual Update
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TJC Revised Requirements
 TJC has published many changes over the past two
years
 Many of the changes reflected in their standards is to be
in compliance with the CMS CoP
 Standards are for hospitals that use them to get deemed
status to allow payment for M/M patients
 This means hospitals do not have to have a survey by
CMS every 3 years
 Can still get a complaint or validation survey
 So now TJC standards crosswalk closer to the CMS CoPs
 Not called JCAHO any more
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Mandatory Compliance
 Hospitals that participate in Medicare or Medicaid
must meet the COPs for all patients in the facilities
and not just those patients who are Medicare or
Medicaid
 Hospitals accredited by TJC, AOA, CIHQ, or DNV
Healthcare have what is called deemed status
 This means you can get reimbursed without going
through a state agency survey
 States can still institute a survey and be more
restrictive
64
CMS Hospital CoPs
 All Interpretative guidelines are in the state
operations manual and are found at this website1
 Appendix A, Tag A-0001 to A-1164
 You can look up any tag number under this manual
 Manuals
 Manuals are now being updated more frequently
 Still need to check survey and certification website
once a month and transmittals to keep up on new
changes
2
1http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
2 http://www.cms.gov/Transmittals/01_overview.asp
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Location of CMS Hospital CoP Manual
Email questions to [email protected] or [email protected]
All the manuals are at
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
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Conditions of Participation (CoPs)
Important interpretive guidelines for hospitals and to
keep handy
 A- Hospitals and C-Critical Access Hospitals
 C-Labs
 V-EMTALA (Rewritten May 29, 2009 and
amended July 2010 and proposed changes)
 Q-Determining Immediate Jeopardy
 I-Life Safety Code Violations
 All CMS forms are on their website
68
Contact for Questions
 Email questions to [email protected] or
[email protected]
 Resource may be your state department of
health or regional CMS office
 The American Hospital Association or state
hospital association may be of assistance
 Note that when changes are published in the
Federal Register or CMS Survey Memo there is
always the name and phone number of a contact
person at CMS to contact for questions
69
Compliance Recommendation
 Assign each section of the hospital CoPs to the
manager of that department
 Do a side by side gap analysis like the TJC PPR
for each section
 Have standard on left side and go line by line and
document compliance on the right side
 Keep a hard copy of CoP and analysis
 Designate someone in charge if a validation,
complaint, or unannounced survey occurs
 Commonly referred to as the CoP king or queen
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CMS Required Education
 These will be discussed throughout presentation:
 Restraint and seclusion (annual-ongoing)
 Abuse, neglect and harassment (annual)
 Infection control, Advance directive
 Medication errors, drug incompatibility and ADR
 Organ donation, Standing orders & protocols
 IVs and blood and blood products P&P, Medication
timing, safe opioid use
 ED common emergencies, IVs and blood and blood
products for ED
71
What’s Really Important
 Life Safety Code Compliance
 Infection Control and CMS received $50 million
grant to enforce and HHS gets 1 billion
 Patient Rights especially R&S and grievances
 EMTALA
 Performance Improvement (CMS calls it QAPI)
 Medication Management
 Dietary and cleanliness of dietary
 Infection control issues in dietary is big!
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What’s Really Important
 Verbal orders, Policies and procedures
 History and physicals
 Need order for respiratory and rehab (such as
physical therapy)
 Need order for diet, medications, and radiology
 Anesthesia (updated four times)
 Standing orders and protocols
 Medications, safe opioid use and blood transfusions
 Note the CMS quarterly Deficiency Memos
73
Survey Protocol
 First 37 pages list the survey protocol,
including sections on:
 Off-survey preparation
Entrance activities
 Information gathering/investigation
Exit conference
 Post survey activities
74
Survey Protocol
 Survey done through observation, interviews,
and document review
 Usually surveys are done Monday - Friday
but can come on weekends or evenings
 Federal law allows CMS or department of
health surveyors access to your facility
 CAH rehab or psych (behavioral health) is
surveyed under this section even though
CAH has a separate manual
75
Survey Team
 Mid-sized hospital with a full survey
 Two to four surveyors for three or more days and at
least one RN with hospital survey experience
 Team based on complexity of services offered
 SA (state agency) decides or RO (regional office)
for federal teams
 Have an organized plan for an unannounced survey
with designated persons to accompany surveyors
 Include education of security or those who attend to the
front desk where surveyors could enter in the morning
76
Interpretive Guidelines
 Starts with a tag number, example A-0001
 “A” refers to the hospital CoPs
 Goes from 0001 to 1164
 The three sections from Federal Register (CFR)
include the regulation, interpretive guidelines and
survey procedure
 Survey procedure
 Not in every section
 Explains survey process, policies that will be reviewed,
questions that will be asked and documents reviewed
77
New website for all manuals
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
78
Compliance with Laws A-0020
 The hospital must be in compliance with all
federal, state, and local laws
 Survey procedure tells surveyor to interview
CEO or other designated by hospital
 Refer non-compliance to proper agency with
jurisdiction such as OSHA (TB, blood borne
pathogen, universal precautions, EPA (Haz mat
or waste issues), or Rehabilitation Act of 1973
 Will ask if cited for any violation since last visit
79
Compliance with Laws Tag 23 & 22
 Hospital must be licensed or approved for
meeting standards for licensure, as applicable
 Personnel must be licensed or certified if required by
state (doctors, nurses, PT, PA, etc.)
 If telemedicine used must be licensed in state
patient located and where practitioner is locate
 Federal law passed and 27 pages IGs by CMS and 6 tag numbers
 Verify that staff and personnel meet all
standards (such as CE’s) required by state law
 Review sample of personnel files to be sure
credentials and licensure is up to date
80
Governing Body (Board) 43
 Hospital must have an effective governing body that
is legally responsible for the conduct of the hospital
 Can share a board in hospital system now
 Written documentation identifies an individual as
being responsible for conduct of hospital operations
 Board makes sure MS requirements are met
 Board must determine which categories of practitioners
are eligible for appointment to medical staff (MS), as
allowed by your state law; CRNA, NP, PA’s, nurse
midwives, chiropractors, podiatrists, dentists, registered
dietician, clinical psychologist, PharmD, social worker
etc.)
81
Governing Body (Board) 43
 No survey of hospital systems
 Can’t just have one policy for the system
 Each individual hospital can use a hospital system’s
policy but they must individually adopt it
 Such as hospital A adopts the policy of XX
Healthsystem
 Hospital must be clear that their hospital has
elected to adopt any specific policy
 Minutes need to be clear of one board for two
hospitals
82
Governing Body (Board) 43
 Each hospital must have their own CNO
 Cannot have one integrated nursing service
department between two separate hospitals just
because they are in the same healthcare system
 It is possible to have one CNO to run two
hospitals if able to carry out the duties of each
hospital
 System may chose to operate QAPI program at the
system level but each certified hospital must have
its own PI data with AE and standardized indicators
83
Medical Staff and Board
 Board must determine what category of practitioners
are eligible for appointment to the MS (44)
 Physicians which includes dentists, podiatrists,
chiropractors, optometrists
 Should grant privileges and be appointed to the MS
 Non-physicians may include PA, NP, CNS, CNM,
CRNA, CSW, clinical psychologist, AA, clinical
pharmacist, RD or nutrition specialist
 Some others may be eligible for privileges based on
state law and MS bylaws and R/R such as PT, OT,
Speech language pathologist
84
Medical Staff and Board
 Board appoints individuals to the MS with the
advice and recommendation of the MS (0046)
 Will review board minutes to make sure they are
involved in appointment of MS
 Board must assure MS has bylaws and they
comply with the CoPs (47)
 Board must make sure they have approved the MS
bylaws and rules and regulations (48) and any
changes
 TJC MS.01.01.01 as to what goes into a bylaw or R/R
85
Medical Staff and Board
 Board must ensure MS is accountable to the board
for the quality of care provided to patients (0049)
 All care given to patients must be by or in
accordance with the order of practitioner who is
operating within privileges granted by the Board
 Need order for any medications
 Need to document the order even if there is a protocol
approved by the medical board for it
 ED nurse starts IV on patient with chest pain and
documents it in the order sheet
 Discussed later under section 405, 406, 457, and 450
86
Board and Medical Staff
 Board ensures that criteria for selection of MS
members is based on (0050)
 MS privileges describe privileging process and
ensure there is written criteria for appt to MS
 Individual character, competence, training,
experience and judgment
 Make sure under no circumstances is staff
membership or privileges based solely on
certification, fellowship, or membership in a
specialty society (0051)
 TJC has a tracer now on this
87
Medical Staff
 Previous CMS regulations limited access by
requiring physicians to co-sign all orders
 Changes eliminate some of the barriers
 This change will allow hospitals to more fully utilize
practitioners skills such as NP or PharmD or RD
 Podiatrist could serve as president of the MS
 Others C&P still have to follow the MS bylaws and
R/R
 Can have categories in MS but MS must still
examine credentials
88
TJC Tracer MS Credentialing and Privileging
 Will look at the design of the MS and look at
verification of credentials, limitations or relinquishing
privileges, health status, morbidity and mortality,
peer recommendations etc
 Consistent process for all practitioners
 Scope of the MS process to determine if all LIPs
and other practitioners are reviewed
 The link between results of ongoing professional
practice evaluation and focused professional
performance evaluation and the adherence to
criteria.
89
TJC Tracer MS Credentialing and Privileging
 How the organization is monitoring the performance
of all licensed independent practitioners on an
ongoing basis
 How does the hospital evaluates performance of
LIPs who do not have current performance
documentation (FPPE)?
 How does the hospital evaluate LIPs who
performance has raised concerns regarding safe
quality care?
 Will look to see if state opted out supervision with
CRNAs, P&Ps for supervision of CRNAs, etc
90
Board and the Medical Staff
 CMS Guidance issued to clarify it is a
recommendation that MS must conduct appraisals
of practitioners at least every 24 months
 Need to do every 24 months if TJC accredited
 MS must examine each practitioner’s qualifications
and competencies to perform each task, activity, or
privilege
 Included current work, specialized training, patient
outcomes, education, currency of compliance with
licensure requirements
 MS section repeated in tag 338-363 so will not duplicate
91
Telemedicine
52
 Medical staff makes a recommendation to do use a
distant site to C&P physicians
 Board agrees and must enter into agreement with
distant site hospital (DSH) or distant site
telemedicine entity (DSTE)
 CMS says what must be in the agreement to make
sure the hospital is in compliance with the CoPs
 Must be licensed in that state
 Provide evidence of C&P and provides copy of their
privileges
92
Telemedicine
52
 Hospital can rely on the C&P decision of the
DSH or DSTE
 The hospital must report to the distant site any
complaints received or information on adverse
events
 Can have one file with telemedicine physicians
or can keep separate file
 Surveyor will look at documentation indicated that it
granted privileges to each telemedicine physician or
that it relied on the distant site entity to do this
93
Board Consultation
New 9-26-2014
 The board must consult directly with person
responsible for the conduct of the MS
 Such as the President of the MS or CMO or designee
 Must include matters related to the quality of
medical care and must have P&P on this
 Can meet face to face or through
telecommunication
 Suggests meet at least twice a year
 If multi-hospital system need to consult with each
separate MS
94
CEO
A 57
 Board must appoint a CEO who is
responsible for managing the hospital
 Verify CEO is responsible for managing entire
hospital
 Verify the board has appointed a CEO
 CEO is a very important position and CMS
has only a small section
 TJC in the leadership standard has more
detailed information on the role of the CEO
95
Care of Patients 63-68
 Board must make sure every patient has to be under
the care of a doctor (or dentist, podiatrist,
chiropractor, psychologist, et. al.)
 Practitioners must be licensed and a member of MS
 If LIPs can admit (NP, Midwives) still need to see
evidence of being under care of MD/DO
 If state law allows needs policies and bylaws to
ensure compliance
 Exception is a separate federal law where no
supervision required by midwives for Medicaid
patients
96
Care of Patients 63-68
 Evidence of being under care of MD/DO must be in
the medical record
 Verify with your state department of health what
documentation is required for inpatients
 Board and MS establish P&P and bylaws to ensure
compliance
 Board must make sure doctor is on duty or on call at
all times, doctor of medicine or osteopathy is
responsible for monitoring care M/M patient
 Interview nurses and make sure they are able to call the
on-call MD/DO and they come to the hospital when needed
97
Care of Patients 67-68
 Patient admitted by dentist, chiropractor,
podiatrist etc., needs to be monitored by a
MD/DO, as allowed by state law
 Each state has a scope of practice which talks
about what they can do
 The board and MS must have policies to make sure
Medicare/Medicaid patient is responsible for any
care OUTSIDE the scope of practice of the
admitting practitioner
 What is the scope of practice in your state for NP,
CRNAs, Midwifes, and PAs?
98
Plan and Budget 73-77
Need institutional plan
 Include annual operating budget with all
anticipated income and expenses
 Provide for capital expenditures for 3 year period
 Identify sources of financing for acquisition of
land improvement of land, buildings and
equipment
 Must be submitted for review
 TJC has similar standards in its leadership chapter
99
Plan and Budget
Need institutional plan
 Must include acquisition of land and
improvement to land and building
 Must be reviewed and updated annually
 Must be prepared under direction of board and a
committee of representatives from the Board
administrative staff, and MS (077)
 Verify that all 3 participated in the plan and
budget
100
Contracted Services
 Board responsible for services provided in hospital
(0083)
 Whether provided by hospital employees or
under contract
 Board must take action under hospital’s QAPI
program to assess services provided both by
employees and under direct contract
 Identify quality problems and ensure monitoring
and correction of any problems
 TJC has more detailed contract management standards
in LD chapter
101
Contracted Services
 Board must ensure services performed under
contract are performed in a safe and efficient
manner
 Increased scrutiny on contracted services
 Review QAPI plan to ensure that every contracted
service is evaluated
 Maintain a list of all contracted services (85)
 Contractor services must be in compliance with
CoPs
 Consider adding section to all contracts to address CoP
requirements
102
Emergency Services 91
 Remember to see the EMTALA separate CoP
 Revised May 29, 2009 and amended July
2010 and now 68 pages
 Consider doing yearly education on EMTALA
to your ED staff and for on call physicians
 If hospital has an ED, you must comply with
section 482.55 requirements
 If no ED services, Board must be sure hospital has
written P&P for emergencies of patients, staff and
visitors
103
CMS EMTALA Manual
www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downlo
ads/som107_Appendixtoc.pdf
104
Emergency Services 91
 Qualified RN must be able to assess patients
 Verify that MS has P&P on how to address
emergency procedures
 Need P&P when patient’s needs exceed hospital’s
capacity
 Need P&P on appropriate transport
 Train staff on what to do in case of an emergency
 Should not rely on 911 for on-campus and need
trained staff to respond to the code or emergency
105
Emergency Services 0091
 If emergency services are provided at the hospital
but not at the off campus department then you need
P&P on what to do at the off-campus department
when they have an emergency
 Do whatever you can to initially treat and stabilize
the patient etc
 Call 911 (off campus only!)
 Provide care consistent with your ability
 Includes visitors, staff and patients
 Make sure staff are oriented to the policy
106
Patient Rights
Many standards related to grievances
and restraint and seclusion (R&S)
Sets forth standards regarding R&S staff
training and education
Sets forth standards on R&S death
reporting
TJC also has chapter on 14 patient rights or
RI “Rights and Responsibilities of the
Individual” starting with RI.01.01.01 thru
02.02.01
107
Number of Deficiencies April 15, 2015
Section
Number Of
Deficiencies
Tag Number
Restraint and Seclusion 1,347
Tag 154-214
Care in a Safe Setting
691
Tag 144
Grievances
Consent & Decision
Making
Freedom from Abuse &
Neglect
653
302
Tag 118-123
Tag 131-132
272
Tag 145
Notice of Patient Rights 194
Tag 116 and 117
Care Planning
Tag 130
99
Number of Deficiencies Apr 15, 2015
Section
Number of
Deficiencies
Tag Number
Privacy and Safety
120
142 and 143
Confidentiality
79
146 and 147
Visitation
28
215-217
Access to Medical Records
Protect Patient Rights
15
462
148
115
Admission Status Notification 13
133
Exercise of Patient Rights
129
Total 4,292
17
Standard # 1 Notice of Rights
 Notice of Patient Rights and Grievance Process
 Hospital must ensure the notice of patient rights are
met
 Provide in a manner the patient will understand
 Remember issue of limited English proficiency
(LEP) as with patients who does not speak
English and low health literacy
 20% of patients read at a sixth grade level
 Must have P&P to ensure patients have information
necessary to exercise their rights
110
Notice of Patient Rights 117 12-11
 Rule #1 - A hospital must inform each patient of the
patient’s rights in advance of furnishing or
discontinuing care
 Must protect and promote each patient’s rights
 Must have P&P to ensure patients have information
on their rights and this includes inpatients and
outpatients
 Must take reasonable steps to determine patient’s
wishes on designation of a representative
 Must give Medicare patient IM Notice within two days of
admission and in advance of discharge if more than two
days
111
Designation of Representative 117
 If patient is not incapacitated and has an individual
to be their representative then the hospital must
provide the representative with the notice of patient
rights in addition to the patient
 Patient can do orally or in writing which author suggests
 If the patient is incapacitated then the notice of
patient rights is given to the person who represents
with an advance directive such as the DPOA
 If incapacitated and no advance directive then to
the person who is spouse, domestic partner, parent
of minor child, or other family member
112
Designation of Representative 117
 This person is known as the patient
representative
 You can not ask for supporting documentation
unless more than one individual claims to be
their representative
 If hospital refuses the request of an individual to
be the patient’s representative then must
document this in the medical record
 CMS says can specify a state law for doing this
 Hospital must adopt P&P on this
113
Notice of Patient Rights
 Confidentiality and privacy
 Pain relief
 Refuse treatment and informed consent
 Advance directives
 Right to get copy for Medicare patients of Important
Message from Medicare such as the IM Notice or
detailed notice
 Right to be free from unnecessary restraints
 Right to determine who visitors will be
114
Notify Patient of Their Rights
 When appropriate, this information is given to the
patient’s representative
 Document reason, patient unconscious, guardian, DPOA,
parent if minor child et. al.
 Consider having a copy on the back of the general
admission consent form and acknowledgment of the
NPP
 Have sentence that patient acknowledges receipt of
their patient rights
 Right to contact the QIO or state agency of
problems
115
Interpreters
 Rule #2 - A hospital must ensure interpreters
are available
 Make sure communication needs of patients
are meet
 Recommend qualified interpreters
 Must comply with Civil Rights law
 Be sure to document that the interpreter was
used
 See TJC Patient Centered Communications Standards
116
Interpreters
 Consider posting a sign in several languages
that interpreting services are available
 Include in yearly skills lab for nurses to make
sure your staff knows what to do and they
understand P&P
 Review your policy and procedure
 If hospital owned physician practices ensure
interpreters are present in prescheduled
appointments
117
Grievance Process 118
 Rule #3 - The hospital must have a process
for prompt resolution of patient grievances
 Hospital must inform each patient to whom to
file a grievance
 Provides definition which you need to include in
your policy
 If TJC accredited combine P&P with complaint
section complaint standard at RI.01.07.01 in which
is similar to CMS now with one addition
 Use the CMS definition of grievance
118
Grievance Process 118
Definition: A patient grievance is a formal or
informal written or verbal complaint
When the verbal complaint about patient
care is not resolved at the time of the
complaint by staff present
 By a patient, or a patient’s representative,
 Regarding the patient’s care, abuse, or neglect,
issues related to the hospital’s compliance with the
CMS CoP or a Medicare beneficiary billing
complaint related to rights
119
Grievances 118
 Hospitals should have process in place to deal with
minor request in more timely manner than a written
request
 Examples: change in bedding, housekeeping of
room, and serving preferred foods
 Does not require written response
 If complaint cannot be resolved at the time of the
complaint or requires further action for resolution
then it is a grievance
 All the CMS requirements for grievances must be
met
120
121
Patient or Their Representative
 If someone other than the patient complains
about care or treatment
 Contact the patient and ask if this person is
their authorized representative
 Get the patient’s permission to discuss
protected health information with designed
person because of HIPAA
 Document in the file that the patient’s permission
was obtained
– Some facilities get a HIPAA compliant form signed
122
Grievances 118
 Not a grievance if patient is satisfied with care but
family member is not
 Billing issues are not generally grievances unless a
quality of care issue
 A written complaint is always a grievance whether
inpatient or outpatient (email and fax is considered
written)
 Information on patient satisfaction surveys
generally not a grievance unless patient asks for
resolution or unless the hospital usually treats that
type of complaint as a grievance
123
Grievances 118
 If complaint is telephoned in after patient is
dismissed then this is also considered a
grievance
 All complaints on abuse, neglect, or patient
harm will always be considered a grievance
 Exception is if post hospital verbal
communication would have been routinely
handled by staff present
 If patient asks you to treat as grievance it will
always be a grievance
124
Grievance Process Survey Procedure
 Review the hospital policy to assure its
grievance process encourages all personnel
to alert appropriate staff concerning
grievances
 Hospital must assure that grievances
involving situations that place patients in
immediate danger are resolved in a timely
manner
 Conduct audits and PI to make sure your
facility is following its grievance P&P
125
Grievance Process - Survey Procedure
 Surveyor will interview patients to make sure they
know how to file a complaint or grievance
 Including right to notify state agency (state
department of health and QIO with phone
numbers)
 Remember to add email address and address of
both
 Document that this is given to the patient
 Remember the TJC APR requirements
 Should be in writing in patient rights section
126
Grievance Process 119
Rule #4 – The hospital must establish a
process for prompt resolution
Inform each patient whom to contact to
file a grievance by name or title
Operator must know where to route calls
Make form accessible to all
127
Grievance Process 119
 Rule #5 – The hospital’s governing board
must approve and is responsible for the
effective operation of the grievance process
 Elevates issue to higher administrative level
 Have a process to address complaints timely
 Coordinate data for PI and look for opportunities
for improvement
 Read this section with the next rule
 Most boards will delegate this to hospital staff
128
Rule #6 Board
Review 119-120
 The hospital’s board must review and resolve
grievances
 Unless it delegates the responsibility in writing to the
grievance committee
 Board is responsible for effective operation of
grievance process
 Grievance process reviewed and analyzed thru hospital’s
PI program
 Grievance committee must be more than one person and
committee needs adequate number of qualified members
to review and resolve
129
Grievance Survey Procedure
Go back and make sure your
governing board has approved the
grievance process
Look for this in the board minutes or a
resolution that the grievance process
has been delegated to a grievance
committee
Does hospital apply what it learns?
130
Grievance Process 120
 Rule #7 – The grievance process must include a
mechanism for timely referral of patient concerns
regarding the quality of care or premature
discharge to the appropriate QIO
 Each state has a state QIO under contract from
CMS and list of QIOs1
 CMS changing to have 2 QIOs cover complaints
and grievance handling and have divided the states
1http://www.qualitynet.org/dcs/ContentServer?pagename=Medqic/MQGeneralPage/GeneralPageTemp
late&name=QIO%20Listings
131
IM and Detailed Notice Forms
 Hospital to provide a Medicare patient with an Important
Message from Medicare ( IM notice ) within 48 hours of
admission
 The hospital must deliver to the patient a copy of this signed
form again if more than two days and within 48 hours of
discharge
 About 1% of Medicare patients voice concern about being
discharge prematurely
 These patients must be given a more detailed notice and
request the QIO to review their case
 New forms IM “You Have the Right” and “Detailed Notice”
 Website for beneficiary notices1
1www.cms.hhs.gov/bni
132
www.cms.hhs.gov/bni
133
KEPRO and Livanta QIOs
www.qionews.org/articles/july-2014-special-focus/beneficiary-and-family-centered-care-qualityimprovement-orga
134
Beneficiary & Family Centered Care QIOs
 Area 1 – Livanta
9090 Junction Drive, Suite 10
Annapolis Junction, MD 20701
Toll-free: 866-815 5440
www.BFCCQIOAREA1.com
 Area 2 – KEPRO
5201 W. Kennedy Blvd., Suite
900 Tampa, FL 33609
Toll-free: 844-455-8708
www.keproqio.com
 Area 4 – KEPRO
5201 W. Kennedy Blvd.,
Suite 900 Tampa, FL 33609
Toll-free: 855-408-8557
www.keproqio.com
 Area 5 – Livanta
9090 Junction Drive, Suite
10 Annapolis Junction, MD
20701
 Area 3 – KEPRO
Toll-free: 877-588-1123
5700 Lombardo Center Dr., Suite
www.BFCCQIOAREA5.co
100 Seven Hills, OH 44131
m
Toll-free: 844-430-9504
www.keproqio.com
135
Beneficiary & Family Centered Care QIOs
 Beneficiary and Family Centered Care (BFCC)QIOs will manage:
 All beneficiary complaints,
 Quality of care reviews,
 EMTALA,
 And other types of case reviews
 To ensure consistency in the review process
while taking into consideration local factors
important to beneficiaries and their families
136
Grievance Procedure 121
 Hospital must have a clear procedure for the
submission of a patient’s written or verbal
grievances
 Surveyor will review your information to make
sure it clearly tells patients how to submit a
verbal or written grievance
 Surveyor will interview patient to make sure
information provided tells them how to submit a
grievance
 Must establish process for prompt resolution of
grievances
137
Hospital Grievance Procedure 0122
Rule #8 – Hospital must have a P&P on
grievance
Specific time frame for reviewing and
responding to the grievance
Grievance resolution that includes the patient
with a written notice of its decision, IN MOST
CASES
 The written notice to the patient must include the
steps taken to investigate the grievance, the results
and date of completion
138
Hospital Grievance Procedure
 Facility must respond to the substance of
each and every grievance
 Need to dig deeper into system problems
indicated by the grievance using the system
analysis approach
 Note the relationship to TJC sentinel event policy
and LD medical error standards, CMS guidelines for
determining immediate jeopardy, HIPAA privacy
and security complaints, and risk
management/patient safety investigations
139
Grievances 7 Day Rule
 Timeframe of 7 days would be considered
appropriate and if not resolved or
investigation not completed within 7 days
must notify patient still working on it and
hospital will follow up
 Most complaints are not complicated and do not
require extensive investigation
 Will look at time frames established
 Must document if grievance is so complicated it
requires an extensive investigation
140
Grievances Written Response 123
 Explanation to the patient must be in a manner
the patient or their legal representative would
understand
 The written response must contain the elements
required in this section - not statements that
could be used in legal action against the hospital
 Written response must the steps taken to
investigate the complaint
 Surveyors will review the written notices to make
sure they comply with this section
141
Grievance 123
CMS says if patient emailed you a complaint,
you may email back response
 Be careful as many hospital policy on security do not
allow this since email is not encrypted
 Under HIPAA patient can agree to increased risks
Must maintain evidence of compliance with
the grievance requirements
Grievance is considered resolved when
patient is satisfied with action or if hospital
has taken appropriate and reasonable action
142
TJC Complaint Standard
TJC has complaint standard RI.01.07.01
Will not cover but provided for reference
TJC calls them complaints
CMS calls them grievances
TJC has eliminated several standards
in that are still CMS standards
More closely cross walked now
143
RI.01.07.01 Complaints & Grievances
Standard: Patient and or her family has the
right to have a complaint reviewed,
EP1 Hospital must establish a complaint and
grievance (C&G) resolution process
 See also MS.09.01.01, EP1
 EP2 Patient and family is informed of the grievance
resolution process
 EP4 Complaints must be reviewed and resolved
when possible
144
RI.01.07.01 Complaints & Grievances
 EP6 Hospital acknowledges receipt of C&G that
cannot be resolved immediately
 Hospital must notify the patient of follow up to
the C&G
 EP7 Must provide the patient with the phone
number and address to file the C&G with the
relevant state authority
 EP10 The patient is allowed to voice C&G and
recommend changes freely with out being
subject to discrimination, coercion, reprisal, or
unreasonable interruption of care
145
RI.01.07.01 TJC Complaints
 EP 17 Board reviews and resolves grievances
unless it delegates this in writing to a grievance
committee (eliminated but still CMS requirement)
 EP 18 Hospital provides individual with a written
notice of its decision which includes (DS);
 Name of hospital contact person
 Steps taken on behalf of the individual to investigate
the grievance
 Results of the process
 Date of completion of the grievance process
146
RI.01.07.01 TJC Complaints
EP19 Hospital determines the time frame
for grievance review and response(DS)
EP20 Process for resolving grievances
includes a timely referral of patient
concerns regarding quality of care or
premature discharge to the QIO
EP21 Board approves the C&G process
(eliminated but still CMS standard)
147
Have a Policy to Hit All the Elements
148
2cd Standard Exercise of Rights
 Right to participate in the development and
implementation of their plan of care
 Right to refuse care and formulate advance
directives
 Right to have a family member or representative of
his or her choice notified if requested
 Called support person in the final visitation regulations
 Right to have his or her physician notified promptly
of the patient's admission to the hospital if patient
requests this
149
Standard #2 Exercise of Rights 130
 Rule #1 – Patients have the right to
participate in the development and
implementation of their plan of care
 Includes inpatients and outpatients
 Includes discharge planning and pain
management
 Requires hospital to actively include the
patient in developing their plan of care
including changes
150
Patient Representative
 Repeats that hospital expected to take reasonable
step to determine patient’s wishes on designation of
a representative with same requirements
 Same standard and if patient is not incapacitated
and has a representative then must involve both in
development and implementation of a plan of care
 If incapacitated and AD then this person is involved
 If incapacitated and no AD then to who claims to be
patient representative and can not ask for
supporting documentation unless two claim to be
the representative
151
Patient Representative
Same requirements about documenting any
refusals to let someone be the representative
in the medical record
Same requirement to follow any specific state
law
Need P&P on this and should teach staff this
section
 Policy must facilitate expeditious and nondiscriminatory resolution of disputes about whether
the person is the patient’s representative
152
Patient Participate in Plan of Care
 If patient refuses to participate, document this
 Include patient’s legal representative if patient minor
or incompetent
 Plan of care is frequently cited
 Do not need a separate plan of care for nursing if
participates in interdisciplinary plan of care
 Patients needing post-hospital care are given choice
home health or nursing homes in writing
 Includes choice to pain management, patient care
issues, and discharge planning
 Section 1802 of SSA guarantees free choice by Medicare patients for
LTC or home health and also in discharge planning section
153
Rule #2 Patients Have a Right:
 To make informed decision regarding their
care
 Being informed of their diagnosis
 To request or refuse treatment
 Right to sign out AMA
 Remember EMTALA requirements if patient is
transferred
 Have patient sign the transfer agreement
154
Informed Consent 131
 CMS has 3 sections in the hospital CoP manual on
informed consent
 Section on informed consent in patient rights on informed
decisions, medical records and surgical services
 The patient has the right to make informed
decisions
 Same provisions related to the patient
representative as before so if competent patient has
a patient representative then you give information to
both regarding the information required to make an
informed decision about the care
155
Patient Representative and Consent
 CMS specifically states that the hospital must obtain
the written consent of the patient representative of a
patient who is not incapacitated
 Continues throughout the inpatient hospitalization or the
outpatient encounter
 Same provisions related to the patient who is
incapacitated as to whether they have a DPOA and
if not then to their patient representative
 If no advance directives the hospital can not ask the
representative for supporting documentation unless
two people claim to be the representative
156
Informed Consent 131
 Right to delegate the right to make informed
decisions to another (DPOA, guardian)
 Patient has a right to an informed consent for
surgery or a treatment
 Right to be informed of health status and to be
involved in care planning and treatment
 Informed decision on discharge planning to post
acute care
 Right to request or refuse treatment and P&P to
assure patient’s right to request or refuse treatment
157
Informed Consent
 Right to informed decisions about planning for
care after discharge
 Right to receive information in a manner that is
understandable (issue of healthcare literacy)
 Right to get information about health status,
diagnosis and prognosis
 Hospital has to have process to ensure these
rights
 Required to have policies and procedures on
all of these
158
Disclosures to Patients 131
There are two disclosures that must be in
writing
 If physician owned hospital
–Surveyor is suppose to ask to ensure disclosed
–Must give to inpatients and observation
patients now and P&P required
 If a doctor or an ED physician is not available 24
hours a day to assist in emergencies
– Individual notice does not have to be given to the ED
patients but must post a sign
159
Disclosures to Patients 131
 Posted sign in DED must says hospital does not
have a MD/DO 24 hours a day
 Must discuss how hospital is going to meet the needs of
the patient and hospital P&P required
 Patient must sign an acknowledgment if admitted
 Must provide information at beginning of inpatient stay
or visit
 Physicians who refer patients to the hospital they have an
ownership interest must disclose this and hospital requires
this as a condition for the physician being credentialed or
privileged
 Patients seen in PAT should receive this information then
160
Patient Rights 132
 Patient has the right to make and have the
advance directives followed when incapacitated
 Staff must provide care that is consistent with
these directives
 P&P must include delegation of patient rights to
representative if patient incompetent
 In addition patient may designate in the AD a
support person to make decision on visitation
 Note rights as inpatient outpatient AD
requirements of Joint Commission
161
Advance Directives
 Your policy should have clear statement of any
limitations such as conscience
 At a minimum, clarify any difference between facility wide
conscience objections and those raised by individual doctors
 But can not refuse to honor designation of a DPOA, support
person or patient representative
 You must provide written information to the patient on
their rights under state law, at time of admission as
an inpatient
 Same notice to 3 types of outpatients; ED, observation
or same day surgery
 Document whether or not they have an AD
162
Advance Directives 132
 Cannot condition treatment on whether or not they
have one
 Not construed as a mechanism to demand
inappropriate or medically unnecessary care
 Ensure compliance with state laws on AD
 Inform patients they may file with state survey
and certification agency
 Provide and document advance directives
education
 Staff on P&P and community
163
Patient Rights
 Includes the right for DPOA to medical
decisions when patient incapacitated such
as informed consent or pain management
 Disseminate policy on advance directive,
identify state authority permitting an
objection
 Includes Psychiatric or behavioral health AD
 The visitation regulations are one of the
newest patient rights
164
Family Member & Doctor Notified 133
 The patient has a right to have a family member or
representative notified and their physician notified
on admission if not aware
 Must now ask every patient on admission and document
 Must do so promptly when patient responds affirmatively
 If patient incapacitated must identify a family
member or representative to promptly notify
 If someone comes with patient or arrives after and
asserts they are the patient’s representative then
hospital accepts this
 Same if two people claim to be their representative & follow state law
165
Privacy & Confidentiality Memo 3-2-12 Tag 143
166
3rd Standard Privacy and Safety 143
 Standard: The patient has a right to personal
privacy while within the hospital
 To receive care in a safe setting
 To be free from all forms of abuse or
harassment
 Rule #1 – The right to personal privacy
 Right to respect, dignity, and comfort
 Privacy during personal hygiene activities
(toileting, bathing, dressing, pelvic exam)
167
Personal Privacy
143
 Need consent for video/electronic monitoring
 Must exist clinical need to do this
 Make sure patient is aware and can see camera
 Such as cameras in patient rooms (sleep lab, ED
safe room, eICU) and not in hallways or lobbies
 Include in your general admission consent form that
all patients sign on admission or make sure patients
are aware such in ICU
 May use to monitor patients who are violent and or
self destructive who are in both restraint and
seclusion
168
Personal Privacy & Confidentiality 143
 Person not involved with care may not be present
while exam is being done unless consent required
(medical students who are observing not those caring
for patient)
 Information in directory may not be disclosed without
informing patient in advance
 Visitor must ask for the patient by name
 Can use information for payment and healthcare
operation
 Must have P&P that restrict access to MR to those
who need to know such as nurse who takes care of
patient
169
Personal Privacy & Confidentiality 143
 Discusses incidental uses and disclosures
 Names on spine of chart
 Names on outside of rooms
 Whiteboards that list patient present in OR or PACU
 Take reasonable safeguards
 Ask waiting patients to stand back a few feet from a
counter used for patient registration
 Speak quietly if patient in semi-private room
 Passwords on computers
 Limit access to areas with light boards or white boards
170
Personal Privacy
 Surveyor will conduct observations to
determine if privacy provided during exams,
treatments, surgery, personal hygiene
activities, etc.
 Surveyor will look to see if names or patient
information is posted in plain view
 Survey procedure will ask if patient names
are posted in public view
 No white boards with patient names and other PHI
171
Privacy and Safety 144
 Rule #2 – The right to receive care in a safe
setting
Includes following standards of care and
practice for environmental safety, infection
control, and security such as preventing
infant abductions, preventing patient falls
and medication errors
 Very broad authority for patient safety issue
 Right to respect for dignity and comfort
172
Care in a Safe Setting
 Includes washing hands between patients see CDC or WHO hand hygiene and TJC
Measuring Hand Hygiene Adherence
 Review and analyze incident or accident
reports to identify problems with a safe
environment
 Review policies and procedures
 How does facility have P&P to curtail
unwanted visitors or contraband materials
173
Privacy and Safety 145
 Rule #3 – The patient has the right to be
free from all forms of abuse or harassment
and neglect
 Must have process in place to prevent this
 Criminal background checks as required
by your state law
 Must provide ongoing (yearly) training on
abuse, harassment, and neglect
174
Privacy and Safety 145
Consider annual training in yearly skills
lab
Must have P&P on this
Adequate staffing section
Have proactive approach to identify
events that could be abuse
TJC and CMS have definitions of what
is abuse and neglect
175
Freedom From Abuse and Neglect
 Abuse is defined as the willful infliction of
injury, unreasonable confinement,
intimidation, or punishment, with resulting
physical harm, pain, or mental anguish
 Includes staff neglect or indifference to infliction
of injury or intimidation of one patient by another
 Include state laws in your P&P on abuse and
neglect
 Remember TJC has standard and definitions,
RI.01.06.03
176
Freedom From Abuse and Neglect
 Neglect is defined as the failure to provide
goods and services necessary to avoid
physical harm, mental anguish, or mental
illness
 Investigate all allegations of abuse or neglect
 Do not hire persons with record of abuse or
neglect
 Report all incidents to proper authority, board
of nursing, etc.
177
Freedom From Abuse and Neglect
 Includes freedom abuse from not just staff but
other patients and visitors
 Hospital must have a mechanism in place to
prevent this
 Effective abuse program includes prevention
 Adequate number of staff who have been screened
 Identify events that could lead to or contribute to
abuse
 Protect during investigation
 Investigate and report and respond
178
Abuse and Neglect
Make sure you have a policy in place for
investigating allegations of abuse
Make sure staffing sufficient across all
shifts
Make sure appropriate action taken if
substantiated
Make sure staff know what to do if they
witness abuse and neglect
179
TJC Abuse and Neglect
Remember to include Joint Commission’s
standard, RI.01.06.03, and definitions of
abuse and neglect into your policy also if
accredited
 Patients have the right to be free from abuse,
neglect, and exploitation
 This includes physical, sexual, mental, or
verbal abuse and Joint Commission has
definitions for all of these terms
180
TJC Abuse and Neglect
Determine how you will protect
patients while they are receiving care
from abuse and neglect
Evaluate all allegations that occur
within the hospital
Report to proper authorities as
required by law
181
Standard #4 Confidentiality
147
 Rule #1 – Patients have a right to confidentiality of
their medical records and to access of their medical
records (0146)
 Sufficient safeguards to ensure access to all information
 HIPAA compliant authorization for release
 Minimal necessary standard such as abstract out
information on child abuse and don’t give protective
services the entire chart
 MR are kept secure and only viewed when
necessary by staff involved in care
 Do not post patient information where it can viewed
by visitors
182
Standard #4 Confidentiality 147
 TJC IM.02.01.01 standard requires that hospital
protects the privacy of health information, maintain
security of same (white boards)
 If white board visible to public hospital may use first
name and first initial of last name
 Must protect patient’s medical record information
from unauthorized person
 Must have a policy and procedure on this
 Obtain patient or patient representative written
authorization to disclose medical record information
183
Patient Records
 Rule #2 – Patients have the right to access
the information contained within their medical
records
 Right to inspect their record or to get a copy
 30 day rule under HIPAA unless state law or P&P
more stringent
 Limited exceptions such as psychotherapy notes,
prisoners if jeopardize health of themselves or
others, information could cause harm to another,
under promise of confidentiality, etc.
184
Access to Medical Records (PHI)
 Rule #3 – Access to the medical record must be
within a reasonably time frame and hospitals can
not frustrate efforts of patients to get records
 If patient is incompetent then to the personal
representative and should sign as the personal
representative such as guardian, parent, or
DPOA
 Reasonable cost for copying, postage or
summary
 No retrieval fee allowed under federal law
185
5th Standard Restraints 154-214
 R&S standards are 50 pages long
 Report deaths in a restraint or within 24 hours of
being in a restraint
 Report also to the regional office if restraint
cause death within 7 days
 Do not need to report death if patient had on only
2 soft wrist restraints and deaths not due to the
restraints
 Use revised R&S form
186
Restraint Patient Safety Brief
www.empsf.org
187
Restraint Worksheet
 CMS has restraint worksheet1 which is an official
OMB form
 Not required for two soft wrist restraints if does not cause
death
 Must still notify regional office by phone the next
business day
 Document this in medical record
 CMS has manual to address complaint surveys
 Put regional office contact information in your P&P1

1www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter06-31.pdf
1www.cms.hhs.gov/RegionalOffices/01_overview.asp
188
Type In Information and Print Off
www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10455.pdf
189
190
Restraint Form CMS-10455
191
Restraints
Regulations only affect regular hospitals
and Critical Access Hospitals have own
manual
CAH do not have a patient rights section
and not required to follow new R&S section
 CAH must have P&P so they can either use
TJC standards or select some or all of
hospital ones
 Some CAH have adopted all if in system with
regular hospitals
192
Standard #5 Restraints
Rule #1 – Patients have a right to be free
from physical or mental abuse, and corporal
punishment
 This includes that restraint and seclusion (RS)
 Will only be used when necessary
 Not as coercion, discipline, convenience or retaliation
 Only used for patient safety and discontinued at earliest
possible time
 R&S guidelines from CMS apply to all hospital
patients even those in behavioral health
193
Right to be Free From Restraint
Hospitals should consider adding it to their
patient rights statement if not already there
Patients are required to be provided a copy
of their rights (staff must document or have
patient sign that they received their rights)
 Could include information in admission
packet
If patient falls do not consider using R&S as
routine part of fall prevention (154)
194
Rule #2 Hospital Leadership’s Role
Like TJC, leadership is responsible for
creating a culture that supports right to be
free from R&S
LD must make sure systems and processes
in place to eliminate inappropriate R&S and
monitors use thru PI process
LD makes sure only used for physical safety
of patient or staff
 LD ensure hospital complies with all R&S
requirements (154)
195
Restraints Protocols
CMS previously did not recognize or
allow the use of protocols like Joint
Commission does
Protocols are now not banned by the new
regulations (168) but still need separate
order for R&S
Must contain information for staff on how
to monitor and apply like intubation
protocol
196
Restraint Standards
 If a patient becomes violent or has self
destructive behavior (V/SD) in the ICU or ED,
CMS has one set of standards that apply
 Decision to use R&S is not driven from diagnosis
but from assessment of the patient
 TJC standards changed rewritten July 1, 2009 to be
cross walked to the CMS guidelines
 10 new standards adopted
 All the R&S standards were eliminated in 2009 except two
(forensic and one on behavioral management) for hospital
who use TJC for deemed status
197
Restraint Standards Medical Patients
Joint Commission calls it behavioral health
and non-behavioral health
CMS calls it violent and or self destructive
(V/SD) and non-violent and non-self
destructive
CMS says it is not the department in which
the patient is located but the behavior of the
patient
198
Rule #3 Know Definition 159
 New definition: Physical restraint is any manual
method, physical or mechanical device, material,
or equipment that immobilizes or reduces the
ability of a patient to move his or her arms, legs,
body, or head freely
 Mechanical restraints include belts, restraint
jackets, cuffs, or ties
 Manual method of holding the patient is a
restraint
199
200
Restraint Definition
A drug or medication when it is used as a
restriction to manage the patient's
behavior or restrict the patient's freedom
of movement and is not a standard
treatment or standard dosage for the
patient's condition (160)
Use of PRN drug is only prohibited if
medication meets definition of drug
 Ativan for ETOH withdrawal symptoms is okay
201
When Drug is Not a Restraint
 Medication is within pharmacy parameters
set by FDA and manufacturer for use
 Use follows national practice standards
 Used to treat a specific condition based on
patient’s symptoms
 Standard treatment would enable patient to
be effective or appropriate functioning
 Includes these in your P&P
202
Definition of Seclusion
 Seclusion is the involuntary confinement of a
patient alone in a room or area from which the
patient is physically prevented from leaving
(162)
 Seclusion may only be used for the
management of violent or self-destructive
behavior (V/SD behavior) that jeopardizes the
immediate physical safety of the patient, a staff
member, or others
 Is not being on a locked unit with others or for
time out if patient can leave area (162)
203
Seclusion
 It is when they are alone in a room and physically
prevented from leaving
 May only use seclusion for management of V/SD
behavior that is danger to patient or others
 Time limits on length of order apply such as four
hours for an adult
 One hour face to face evaluation must be done
(183)
 Therapeutic holds to manage V/SD patients are a
form of restraint
204
Restraints Do Not Include
 Forensic restraints such as handcuffs, shackles, or
other restrictive devices applied by law
enforcement or police are not R&S (0154)
 Closely monitor and observe for safety reasons
 Orthopedically prescribed devices, surgical
dressings or bandages, protective helmets
(161)
 Methods that involve the physical holding of
a patient for the purpose of conducting
routine physical examinations or tests (161)
205
Restraints Do Not Include
 Protecting the patient from falling out of bed
 Cannot use side rails to prevent patient from getting
out of bed if patient can not lower
 Narrow carts and their use of side rails are not a
restraint
 Seat belt in wheelchairs
 IV board unless tied down or attached to bed
 Postural support devices for positioning or securing
(161)
 Device used to position a patient during surgery or
while taking an x-ray
206
Restraints Do Not Include
 Recovery from anesthesia is part of surgical
procedure and medically necessary (161)
 Mitts unless tied down or pinned down or unless so
bulky or applied so tightly patient can not use or
bend their hand (161)
 Mitts that look like boxing gloves are a restraint
 Padded side rails put up when on seizure precaution
 Giving child a shot to protect them from injury (161)
 Physically holding a patient for forced medications
is a physical restraint
207
Restraints Do Include
 Tucking in a sheet so tight patient could not
move (159)
 Use of enclosed bed or net bed unless the
patient can freely exit the bed such as zipper
inside the bed
 Freedom splint that immobilizes limb
 Remember that is it not the thing but what the
thing does to the patient in which their
movement is restricted
208
So, Is This a Restraint?
209
Restraint Chair Used by Law Enforcement
 Emergency restraint
chair
 Manufacturer states
used for safe
transports to hospital
or court
 Safely restrains a
combative or self
destructive person
210
Restraints
 Devices with multiple purposes - such as
side rails or Geri chairs, when they cannot
be easily removed by the patient
 Restrict the patient’s movement constitute a
restraint
 If belt across patient in wheelchair and he can
unsnap belt or Velcro then it is not a restraint (159)
 If patient can lower side rails when she wants then
it is not a restraint but document this
 If a patient can remove a device it is not a restraint
211
Restraints
 Stroller safety belts, swing safety belts, high
chair lap belts, raised crib rails, and crib
covers (161) are okay as long as age or
developmentally appropriate
 Use of these safety intervention must be
addressed in your policy
 Holding an infant or toddler is not a restraint
212
Weapons 154
 CMS does not consider the use of weapons by
hospital staff on patients as safe in the
application of restraint (154)
 Could use on criminal breaking into building
 Weapons include pepper spray, mace, nightsticks,
tazers, stun guns, pistols, etc.
 Okay if patient is arrested and use by law
enforcement such as non-employed staff like police
as state and federal laws
 Be sure to share this section with security
213
Assessment
 Should do comprehensive assessment and
assess to reduce risk of slipping, tripping or
falling
 To identify medical problems that could be
causing behavioral changes (0154) such as
increased temp, hypoxia, low blood sugar,
electrolyte imbalance, drug interactions, etc.
 Use of restraint is not considered routine
part of a falls prevention program (154)
214
Determine Reason for R&S
 Surveyor will look to see if there is evidence that
staff determined the reason for the R&S (154)
 This should be documented and be specific
 Consider a field on the order sheet to include this
 Usually to prevent danger to the patient or others
 Danger to self, maintain therapeutic environment
such as to prevent patient from removing vital
equipment, physically attempting to harm others or
property, patient demonstrated lack of
understanding to comply with safety directions
215
Reasons to Restrain
(Check all that apply)
 Unable to follow directions
 Aggressive
 Disruptive/combative
 History of hip fracture/falls
 Self injury
 Interference with treatments
 Removal of medical devices
 Other: ____________________________
216
Rule #4 Less Restrictive
Restraints can only be used when less restrictive
interventions have been determined to be
ineffective to protect the patient or others from
harm (154, 164, 165,)
Type or technique used must also be least
restrictive
Is what the patient doing a hazard?
 Allowing sundowners to walk or wander at night (154)
Request from patient or family member is not
sufficient basis for using if not indicated by
condition of patient
217
Less Restrictive
Must do an assessment of patient
Must document that restraint is least
restrictive intervention to protect patient
safety based on assessment
What was the effect of least restrictive
intervention
You must train on what is least restrictive
interventions
218
Least Restrictive Restraint to More
219
Rule # 5 Alternatives
Alternatives should be considered along with
less restrictive interventions (186)
What are other things you could do to prevent
using R&S such as sitter or family member stays
with patient
Distractions such as watching video games or
working on a laptop computer
Try nonphysical intervention skills (200)
Considering having a list of alternatives in the toolkit
220
Consider Alternatives
221
Alternatives to Restraints
Be calm and reassuring
Approach in non-threatening manner
Wrap around Velcro band while in wheelchair
(if can release)
Relaxation tapes
Do photo album
Back rubs or massage therapist
Wanderguard system
Limit caffeine
222
Alternatives to Restraints
Watching TV
Massage or family can hire massage
therapist
Punching bag
Avoid sensory overload
Fish tanks
Tapes of families or friends
223
224
225
Restraints LIP Can Write Orders
Rule #6 LIPs can write orders for restraints
Any individual permitted by both state law
and hospital policy for patients
independently, within the scope of their
licensure, and consistent with granted
privileges, to order restraint, seclusion
 NP, licensed resident, but not a medical student
and CMS said usually not a PA
Remember must specify who in your P&P (168)
226
Restraints Notify Doctor ASAP 170
Rule #7 - Any established time frames must be
consistent with asap (not in 1 or 3 hours)
Hospital MS policy determine who is the attending
physician
Hospital P&P should address the definition of asap
(182,170)
RN or PA who does 1 hour face-to-face must notify
attending physician and discuss findings (182)
Be sure to document if LIP or nurse notifies
physician
227
Restraints Order Needed
Rule #8 An order must be received for the restraint
by the physician or other LIP who is responsible for
the care of the patient (168)
Include in P&P use in an emergency
P&P to include category of who can order (PA, NP,
resident, can not be med student)
PRN order prohibited if for medication used as a
restraint, okay if not a restraint
No PRN order for restraints either (167, 169),
except for 3 exceptions (169)
228
PRN Order 3 Exceptions
Repetitive self-mutilating behavior (169),
such as Lesch-Nyham Syndrome
Geri chair if patients requires tray to be
locked in place when out of bed
Raised side rails if requires all 4 side rails to
be up when the patient is in bed
Do not need new order every time but still a
restraint
229
Rule #9 Plan of Care
Restraints must be used in accordance with a
written modification to the patient's plan of care
(166)
 What was the goal of the plan of care
 Use of restraint should be in modified plan of care
Care plan should be reviewed and updated in
writing
 Within time frame specified in P&P (166)
 Plan reflects a loop of assessment, intervention,
evaluation and reevaluation
230
231
Restraints and Plan of Care
Orders are time limited and this is included in
the plan of care
For patient who is V/SD may want to debrief
as part of plan of care but not mandated by
CMS
 Many states require for behavioral health department
Debriefing no longer mandated by TJC for
behavioral patients (deemed status)but deescalation is in PC.01.01.01
Can add information on debrief to R&S toolkit
232
Rule #10 End at Earliest Time
Restraints must be discontinued at the
earliest possible time (154, 174)
Regardless of the time identified in the order
If you discontinue and still time left on clock
and behavior reoccurs, you need to get a
new order
Temporary release for caring for patient is okay
(feeding, ROM, toileting) but a trial release is seen
as a PRN order and not permitted (169)
233
Restraints - End at Earliest Time
Restraints only used while unsafe condition exists
The hospital policy should include who has authority
to discontinue restraints (154, 174)
Under what circumstances restraints are to be
discontinued and who is allowed to take them off
Based on determination that patients behavior is no
longer a threat to self, staff, or others (put this in
your P&P)
Surveyors will look at hospital policy
Policy should also include procedures to follow
when staff need to apply in an emergency
234
Rule #11 Assessment of Patient
Staff must assess and monitor patient’s
condition on ongoing basis (0154, 174, 175)
Physician or LIP must provide ongoing
monitoring and assessment also (175)
One reason to determine is if R&S can be
removed
Took out word continually monitored except
for V/SD patients and says at an interval
determined by hospital policy
235
Rule #11 Assessment of Patient
Intervals are based on patient’s need, condition
and type of restraint used (V/SD or not)
CMS doesn’t specify time frame for assessment
like TJC use to (TJC use to say every 2 hours
for medical patients and every 15 minutes for
behavioral health patients)
CMS says this may be sufficient or waking
patient up every 2 hours in night might be
excessive
This must be in your hospital P&P frequency of
evaluations and assessments (175) and
document to show compliance
236
Rule #12 Documentation
Most hospital use special documentation sheet for
assessment parameters, including frequency of
assessment, and hospital policy should address
each of these (175, 184)
If doctor writes a new order or renews order need
documentation that describes patients clinical needs
and supports continued use (174)
 Document; fluids offered (hydration needs), vital signs
 Toileting offered (elimination needs)
 Removal of restraint and ROM and repositioning
 Mental status, circulation
237
Rule #12 Documentation
Attempts to reduce restraints, skin integrity, and
level of distress or agitation, et. al.
Document the patient’s behavior and
interventions used
Behavior should be documented in descriptive
terms to evaluate the appropriateness of the
intervention (185)
 Example, patient states the Martians have landed and
attempting to strike the nurses with his fists. Patient
attempting to bite the nurse on her arm. Patient picked up
chair and threw it against the window
238
Rule #12 Documentation
Document clinical response to the
intervention (188)
Symptoms and condition that warranted the
restraint must be documented (187)
Have the restraint toolkit where you have the
documentation sheet with the requirements,
the order sheet, manufacturer instructions for
the restraints, articles, etc.
 Many have separate order sheets for V/SD (behavioral
health) and non V/SD (non behavioral health)
239
Document Type of Restraint
240
Not a Good Documentation Sheet
241
Log and QAPI
Hospital take actions thru QAPI activities
Hospital leadership should assess and
monitor use to make sure medically
necessary
Consider log to record use-shift, date, time,
staff who initiated, date and time each
episode was initiated, type of restraint used,
whether any injuries of patient or staff, age
and gender of patient
242
243
244
Rule #13 Use as Directed
Restraints and seclusion must be implemented in
accordance with safe, appropriate restraining
techniques (167)
As determined by hospital policy in accordance
with state law
Use according to manufacturer’s instructions and
include in your policy as attachment
Follow any state law provision or standards of care
and practice
Was there any injury to patient and if so fill out
incident report
245
Rule #14 One Hour Rule
The lighting rod for public comment and AHA
sued CMS over this provision
Standard for behavioral health patients or V/SD
Time limits for R&S used to manage V/SD
behavioral and drugs used as restraint to
manage them(178)
Must see (face to face visit) and evaluate the
need for R&S within one hour after the initiation
of this intervention
246
One Hour Rule 178
Big change is face to face evaluation can be done
by physician, LIP or a RN or PA trained under
482.13 (f)
Physician does not have to come to the hospital to
see patient now, telephone conference may be
appropriate
Training requirements are detailed and discussed
later
To rule out possible underlying causes of
contributing factors to the patient’s behavior
247
One Hour Rule Assessment 482.13 (f)
Must see the patient face-to-face within 1-hour
after the initiation of the intervention, unless state
law more restrictive (179)
Practitioner must evaluate the patient's immediate
situation
The patient's reaction to the intervention
The patient's medical and behavioral condition
And the need to continue or terminate the restraint
or seclusion
Must document this (184) and change
documentation form to capture this information
248
One Hour Rule Assessment 482.13 (f)
Include in form evaluation includes physical and
behavioral assessment (179)
This would include a review of systems, behavioral
assessment, as well as
Patient’s history, drugs and medications and most
recent lab tests
Look for other causes such as drug interactions,
electrolyte imbalance, hypoxia, sepsis etc. that are
contributing to the V/SD behavior
Document change in the plan of care
Must be trained in all the above (196)
249
Rule #15 Time Limited Orders
Time limits apply- written order is limited to
(171)
4 hours for adults
2 hours for children (9-17)
1 hour for under age 9
Related to R&S for violent or self destructive
behavior and for safety of patient or staff
Standard same now for Joint Commission time
frame for how long the order is good for and closely
aligned now
250
251
Rule #16 Renew Order
The original order for both violent or
destructive may be renewed up to 24 hours
then physician reevaluates
Nurse evaluates patient and shares assessment
with practitioner when need order to renew (171,
172)
Unless state law if more restrictive
After the original order expires, the MD or LIP
must see the patient and assess before issuing a
new order
252
Rule #16 Renew Order
Each order for non violent or non-destructive
patients may be renewed as authorized by
hospital policy (173)
Remember TJC requires an order to renew nonbehavioral health patients) according to your
policy
It could be daily or every 24 or 48 hours
Different from patients who are violent and or self
destructive which is every 24 hours
CMS and TJC the same
253
Rule #17 Need Policy on R&S
Will interview staff to make sure they know
the policy (154)
Consider training on policy in orientation and
during the annual in-service and when
changes made
Remember hitting restraints hard in the
survey process
Surveyor to look at use of R&S and make
sure it is consistent with the policy
254
255
Rule #18 Staff Education
New staff training requirements
All staff having direct patient contact must have
ongoing education and training in the proper and
safe use of restraints and able to demonstrate
competency (175)
Yearly education of staff as when skills lab is done
Document competency and training
Hospital P&P should identify what categories of
staff are responsible for assessing and monitoring
the patient (RN, LPN, Nursing assistant, 175)
256
Rule #18 Staff Education
Patients have a right to safe implementation of
RS by trained staff (194)
Training plays critical role in reducing use (194)
Staff, including agency nurses, must not only be
trained but must be able to demonstrate
competency in the following:
The application of restraints (how to put them
on), monitoring, and how to provide care to
patients in restraints
257
Rule #18 Staff Education
This must be done before performing any of
these functions (196)
Training must occur in orientation before
new staff can use them on a patient
Training must occur on periodic basis
consistent with hospital policy
Have a form to document that each of the
education requirements have been met
258
Rule #18 Staff Education
Again consider yearly during skills lab
Remember that the Joint Commission PC.03.03.03
and 03.02.03 requires staff training and competency
now
The hospital must require appropriate staff to
have education, training, and demonstrated
knowledge based on the specific needs of the
patient population in at least the following
Techniques to identify staff and patient
behaviors, events, and environmental factors
that may trigger circumstances that require RS
259
De-Escalation
 Consider document in your tool kit although not required by
CMS
– Required by TJC in PC.01.01.01
 Teach staff what is de-escalation and not just staff on the
behavioral health unit
 Avoid confrontation and approach in a calm manner
 Active listening
 Valid feelings such as “you sound like you are angry”
 Some have personal de-escalation plan that lists triggers such
as not being listening to, feeling pressured, being touched, loud
noises, being stared at, arguments, people yelling, darkness,
being teased, etc.
260
261
Staff Education
The use of non-physical intervention skills
(200)
Choosing the least restrictive intervention
based on an individualized assessment of the
patient's medical, or behavioral status or
condition (201)
The safe application and use of all types of R&S
used in the hospital, including training in how to
recognize and respond to signs of physical and
psychological distress (for example, positional
asphyxia, 202)
262
Staff Education
Clinical identification of specific behavioral
changes that indicate that restraint or seclusion is
no longer necessary (204)
Monitoring the physical and psychological wellbeing of the patient who is restrained or secluded,
including but not limited to, respiratory and
circulatory status, skin integrity, vital signs, and
any special requirements specified by hospital
policy associated with the 1-hour face-to-face
evaluation (205)
263
Staff Education
Including respiratory and circulatory status, skin
integrity, VS, and special requirements of 1 hour face
to face
The use of first aid techniques and certification in the
use of cardiopulmonary resuscitation, including
required periodic recertification (206) Patients in R or
S are at higher risk for death or injury
All staff who apply, monitor, access, or provide care
to patient in R must have education and training in
first aid technique and certified in CPR
 To render first aid if patient in distress or injured
 Develop scenarios and develop first aid class to address
these
264
Staff Education
Staff must be qualified as evidenced by education,
training, and experience
Hospital must document in personnel records that
the training and competency were successfully
completed (208)
Security guards respond to V/SD patients would
need to train
 Many give a 8 hour CPI course
 Don’t want someone going into the room of a V/SD patient
without training to prevent injury to staff and patient
265
Training Cost
Individuals doing training program must be
qualified
Trainers must have high level of knowledge and
need to document their qualifications
Train the trainer programs are done by many
facilities
CMS said need to revise your training program
every year which should take person 4 hours to do
 Can have librarian do literature search for new articles on
evidenced based restraint research
266
Training Time and Time Spent
National Association of Psychiatric Health Systems
(NAPHS), initial training in de-escalation
techniques, restraint and seclusion policies and
procedures
Recommended 7-16 hours of training but number of
hours not mandated by CMS
 Just make sure your staff know the R&S requirements
In fact, in Federal Register recommended sending
one person to CPI training class as a train the
trainer
 1http://www.crisisprevention.com
267
Education Physicians and LIPs
Physician and other LIP training requirements
must be specified in hospital policy (176)
 Consider having physician sign attestation and give them
copy every two years when re-credentialing
At a minimum, physicians and other LIPs authorized
to order R or S by hospital policy in accordance with
State law must have a working knowledge of
hospital policy regarding the use of restraint or
seclusion
Hospitals have flexibility to determine what other
training physicians and LIPs need
268
Rule #19 Stricter State Laws
The following requirements will be
superseded by existing state laws that are
more restrictive (180)
State laws can be stricter but not weaker or
they are preempted
States are always free to be more restrictive
Many states have a state department of mental
health which has standards for patients that are
in a behavioral health unit
269
Rule #20 1:1 Monitoring R&S 183
For behavioral health patients- which CMS now
calls violent or self destructive behavioral that is a
danger to self or others
Can’t use R&S together unless the patient is
visually monitored in person face to face or by an
audio and video equipment
Person to monitor patient face to face or via audio
& visual must be assigned and a trained staff
member
 Must be in close proximity to the patient (183)
 There must be documentation of this in the medical record
270
Rule #20 1:1 Monitoring RS 0183
Documentation will include least restrictive
interventions, conditions or symptoms that
warranted RS, patient’s response to
intervention, and rationale for continued use
This needs to be in hospitals P&P
Modify assessment sheets to include this
information
Consider sitter policy to ensure does not
leave patient unsupervised
271
Rule #21 Deaths
Report any death associated with the use of
restraint or seclusion
Remember, the Safe Medical Devices Act
(SMDA) also requires reporting
Sentinel event reporting to Joint Commission
is voluntary but need to do RCA within 45
days
See Hospital Reporting of Deaths Related to RS,
OIG Report, September 2006, OEI-09-04-003501
1www.oig.hhs.gov
272
Rule #21 Deaths 0214 2013
The hospital must report to CMS each death that
occurs while a patient is in restraint or in seclusion
at the hospital
Must report every death that occurs within 24 hours
after the patient has been removed from R&S
 Except if patient dies in one or two soft wrist restraints and
the restraints did not cause the death
 Document in MR and complete internal log
Each death known to the hospital that occurs within
1 week after R&S where it is reasonable to assume
that use of restraint or placement in seclusion
contributed directly or indirectly to a patient's death
273
Rule #21 Deaths 214
“Reasonable to assume” includes, but is not limited
to, deaths related to restrictions of movement for
prolonged periods of time, or death related to chest
compression, restriction of breathing or
asphyxiation
Must be reported to CMS regional office by
telephone no later than the close of business the
next business day following knowledge of the
patient's death
 This is in the regulation even though some of the regional
offices are telling hospitals just to fax in the form
274
Soft Wrist Restraints
 Will need to include information in internal log
 Log must be done asap and never any later than 7 days
 Log must include patient’s name, date of birth, date of
death, attending physician, primary diagnosis, and
medical record number
 Name of practitioner responsible for patient could be used
in lieu of attending if under care on non-physician
practitioner
 CMS could request to review the log at anytime
 Would still require reporting of deaths within seven
 Need to rewrite policies and procedures and train all staff
275
Rule #21 Deaths 0214
Staff must document in the patient's medical
record the date and time the death was
reported to CMS
This includes patients in soft wrist restraints
Hospitals should revise post mortem records
to list this requirement
Hospitals need to rewrite their policies and
procedures to include these requirements
276
Visitation 215
 A hospital must have written P&P regarding the
visitation rights of patient
 Must include any reasonable or clinically
necessary restrictions
 Does not recommend restricting visitation in ICU
 Same day surgery patients may wish to have a
support person present during pre-op and post-op
recovery
 An outpatient may wish to have a support person
present during examination by the physician
277
Visitation 215
 Need written P&P to address patient’s right to have
visitors
 Any restrictions must be clinically necessary or
reasonable
 Can be restricted if interferes with the care of the
patient or others
 Restrictions for child visitors
 Restrictions may include; infection control issue,
court order, disruptive visitor, patient or room mate
needs rest, inpatient substance abuse program,
patient is having a procedure, etc.
278
Visitation Rights Notice
216
 Hospital must have written P&P on visitation rights
 Policy includes the restrictions
 Hospital must inform each patient of any restrictions
to visitation and must document it was given
 Inform patient of the right to receive visitors their
choose and they can change their mind
 This includes spouse, same sex partner, friend, or family
 Support person may be the same or different from
the patient representative
 Any refusal to honor must be documented in the chart
279
Patient Visitation Rights 217
 The hospital policy must ensure that all visitors
enjoy full and equal visitation rights no matter who
they are
 Can not discriminate based on sex, gender, sexual
orientation, race, or disability
 Surveyor will ask patients if visitors restricted
against their wishes and if so was it in the P&P
 Hospital needs to educate the staff
 Consider in orientation and periodically
 Should have a culturally competent training program
280
Support Person
281
Adverse Event Reporting
 Hospitals are required to track AE
 Several reports show that nurses and others were
not reporting adverse events and not getting into
the PI system
 OIG recommends using the AHRQ common
formats to help with the tracking
 States could help hospitals improve the reporting
process
 Encouraged all surveyors to develop an
understanding of this tool
282
Report Adverse Events to PI
283
Hospital CoPs for QI
CMS issued new hospital COPs for QA and
Performance Improvement
CMS issues Memo March 15, 2013 on AHRQ
Common Formats
 Hospitals are required to track adverse events for PI
Starts with tag number 0263
Short section because the hospital compare
program is not part of the CMS CoP
 Hospital compare is the indicators that must be sent to
CMS to receive full reimbursement rates
284
hwww.psoppc.org/web/patientsafety
285
Hospital Common Formats
286
Changes to QAPI
 CMS issues a revised manual on March 21,
2014 and goes from 34 to 8 tags
 Rewrites 7 of the 8 Tags;
 273, 283, 286, 297, 308, 309, and 315
 Remember that QAPI is important to both CMS
and TJC
 Recall that one of the three CMS worksheets is
on QAPI
 QAPI starts at tag 263
287
March 21, 2014 Manual Rewrites 7 Tags
288
Hospital CoPs for QAPI 263
Standard: Must have PI program that is
ongoing, data driven, and effective,
Board must make sure that PI program
reflects the complexity of the hospital’s
organization and services
Must involve all departments including
contracted services
Focus on indicators to improve health
outcomes
289
Program Scope 273
Standard: PI program needs to be ongoing
and show measurable improvements to
improve health outcomes
 Must measure, analyze and track the quality
indicators
 Must incorporate data to measure the
effectiveness and safety of services and the
quality of care
 How often the data is collected must be
specified by the board
290
CMS Hospital CoPs
Triggers can help hospitals find errors
Look at information submitted to or from QIO
Use data to identify opportunities for improvement
(283)
Focus on high risk, high volume, or problem
prone areas
Consider the incidence, severity, and severity of
problems in those areas
Take action to improve and track the
improvements made
 1www.ihi.org
291
Patient Safety, Medical Errors, AE 286
 Standard: PI program must include indicators to
identify and reduce medical errors
 Track medical errors and ADE
 Analyze their causes and implement preventive
actions
 Example would be a RCA or root cause analysis
 Board is responsible for the operations of the
hospital
 Medical staff and administrative staff are
accountable to make sure clear expectations for
safety
292
QAPI Program 2014
 So does the program show measurable
improvements, that identifies and reduces medical
errors
Diagnostic errors, equipment failures, blood
transfusion injuries, or medication errors
Medical errors may be difficult to detect in
hospitals and are under reported
Make sure incident reports filled out for errors and
near misses
Make sure RCA done when indicated
293
PI Projects 297
Standard: Hospital must conduct PI projects
 How many the hospital does depends on how
big they are and what types of services are
provided
 May develop and information technology system
to improve patient safety and quality
 Document the projects and reasons for doing
 Can participate in a QIO project or do one that is
of comparable effort
294
CMS Hospital CoPs QAPI
QIO to advance quality of care for Medicare
patients
Every state has a QIO or Quality Improvement
Organization under contract by CMS
Sign up with your state QIO to get newsletters
and other information
CMS has a website on information about QIOs
CMS has the mission to improve services
provided to Medicare patients
295
296
Executive Responsibilities 309
Standard: Board assumes full legal authority
and responsibility for the operations of the
hospital
 Medical Staff and Administrative officials are
responsible and accountable for the following:
 Ongoing PI program that includes patient safety
including reducing medical errors
 Hospital wide PI and patient safety program
 A determination of the number of PI projects that
is conducted annually
297
Adequate Resources 315
Standard: The board, Medical Staff, and
Administrative Officials are accountable for
measuring, assessing, improving and
sustaining the hospital’s performance
 This also requires reducing risk to patients
 Example; hospitals created a process to ensure MI
patients got their thrombolytics timely, that PCI was
done before 90 minutes and pneumonia patients
got their antibiotics and blood culture timely
 Process to make sure the improvements continue
298
QAPI Patient Safety
This means people who can attend meetings,
data so analysis can be made and other
resources
Safer IV pumps, new anticoagulant program,
implement central line bundle, sepsis, and VAP
bundle, preventing inpatient suicides, wrong site
surgery, retained FB, new processes for
neuromuscular blocker agents, implement policy
on Phenergan administration and Fentanyl
patches
So what’s in your PI and Safety Plans?
299
Hospital CoPs for QAPI
Must have PI program that is ongoing and
shows measurable improvements, that
identifies and reduces medical errors
Diagnostic errors, equipment failures, blood
transfusion injuries, or medication errors
Medical errors may be difficult to detect in hospitals
and are under reported
Make sure incident reports filled out for errors and
near misses
Remember the QAPI Worksheet
300
Medical Staff 0338
Hospital must have an organized MS that
operates under bylaws approved by Board
Must have MS bylaws that apply equally to
all
See previous MS sections 0044-94
 Most of these have been discussed previously
Each hospital can have a separate medical
staff or a unified integrated (shared) medical
staff if requirements are meet
301
Medical Staff
Medical staff would have to pass a vote by
the majority to have a unified integrated
medical staff
Hospitals must be part of the system
The unified medical staff would have
appropriate by-laws that would include a
process where the voting members of each
separate hospital are advised of their right to
opt out and return to a separate and distinct
medical staff
302
Medical Staff
 The unified integrated medical staff has P&Ps to
ensure the needs of the separately certified
hospitals are given consideration and that local
issues are addressed
 MS may include doctors and other categories of
physicians and non-physicians who are eligible for
appointment to the MS (339)
 As long as consistent with state law and the state scope of
practice (341)
 All practitioners privileged must follow and be evaluated under
the by-laws and R/R of the MS
 Must examine their credentials
303
Medical Staff 0340
MS can include other categories of non-physicians
determined to be eligible
 But must follow state scope of practice law such as
dietician, PharmD, NP, or PA
MS must periodically conduct appraisals of its
members
 MS bylaws determine frequency of appraisals
Recommends at least every 24 months (TJC C&P is
24 months)
To be sure they are suitable for continued membership
304
Medical Staff 0340
Must evaluate MS qualifications and
competencies, within scope of practice or
privileges requested
Look at special training, current work
practice, patient outcomes, education,
maintenance of CME, adherence to MS
rules, certification, licensure and compliance
with licensure requirements
 Want to be sure the MS is credentialed and privileged to
do what they are competent to perform
305
Medical Staff Appraisals
Appraisal procedures must evaluate each member
To determine if should be continued, revised,
terminated or changed
If requests for privileges goes beyond the specified
list for that category of practitioners need appraisal
by MS and approval by the board
Must keep separate credentials file for each MS
member
 If limit privileges must follow laws such as reporting to NPDB
 MS bylaws need to identify process for periodic appraisals
306
Medical Staff 0341 and 342
MS must examine credentials and make
recommendations to the board on appointment of
the candidates and must look at the following
 Request for privileges, evidence of current licensure,
training and professional education, documented
experience, and supporting references of competence
 Can’t make a recommendation based solely on presence
or absence of board certification although can require
board certification
 MS must examine credentials of all eligible to be on the
MS including non-physicians (NP, PA, PharmD etc.)
Telemedicine standards repeated in tag 342 & 343
307
Medical Staff Organization 347
MS is accountable to Board for quality of medical
care provided whether single or shared MS
If MS has executive committee, majority of
members must be MD/DO
Responsibility for the MS is assigned to MD, DO,
dentist or podiatrist
 MS must be well organized-formalized organizational
structure and lines are delineated between the MS and the
Board & can have MEC Committee to represent MS
MS must have bylaws and must enforce bylaws and
Board must approve bylaws
308
Hospital Part of a System 348
 If hospital is part of a system and has a shared
(unified integrated) MS each hospital must
demonstrate
 It is not necessary for each of the hospitals to have
its own MS bylaws and R/R
 Detailed section so just need to read the rules
 If had a shared MS before July 11, 2014 then
evidence of the board’s election to do this
 Must still be consistent with state law & document this
 MS must still be informed of the right to change their minds
and opt out of the shared MS
309
Hospital System 349
 If hospital is part of a hospital system, then can
decide to have shared MS if consistent with state
law
 MS must have voted by a majority who hold
privileges to be a shared MS or to opt out and have
a single MS
 Physicians who only hold telemedicine privileges are not
eligible to vote
 Board must also approve
 Must amend bylaws and R/R
310
Hospital System & Shared MS 350
 Hospital systems that elects to have a shared MS
must demonstrate that
 There are revised MS bylaws and R/R
 Describe the process for self governance,
appointment, C&P, and oversight
 Must describe process for peer review P&P and due
process rights
 Must include process to opt out later of the shared
MS
 Will look for documentation of the above things
311
Hospital System & Shared MS 351
 If hospital is part of a system and decides to have a
shared MS then must take into account each member
hospital’s unique circumstances
 Must consider any difference in patient populations
 This could include rehab hospital, children’s hospital,
acute care, LTC, or behavioral health hospital
 Hospitals with similar populations and located close to
each other would have fewer challenges
 Leadership and MS must be able to explain decision
 How does MS approve standing orders, P&P, etc.
(352)
312
Medical Staff
MS must adopt and enforce bylaws (353)
Board must approve bylaws and any changes
also (354)
 TJC has MS.01.01.01 which tells when to put things in the
by-laws, rules or responsibilities or policies
 TJC does C&P tracer since such an important area
MS bylaws must include statement of duties and
privileges in each category, ( eg. participate in PI,
evaluate practitioner on objective criteria, promote
appropriate use of health care resources, 355)
313
Medical Staff
Privileges for each category ( eg. active,
courtesy, consulting, referring, emergency
case)
Can not assume every practitioner can
perform every task/activity/privilege that is
specified for that category of practitioner
Individual ability to perform each must be
individually assessed (core privileging, 355)
314
Medical Staff
MS bylaws must describe organizational
structure of the MS (356)
Lay out R&R which make it clear what are
acceptable standards of patient care for
diagnosis, medical, surgical care, and rehab
Survey procedure-describe formation of MS
leadership
Survey procedure-verify bylaws describe who is
responsible for review and evaluation of the clinical
work of MS
315
Medical Staff
MS bylaws must describe the qualifications
to be met by a candidate for membership on
the MS (eg. provide level of acceptable care,
complete medical records timely, participate
in QI, be licensed, Tag 357)
Survey procedure-MS bylaws describe
qualifications as character, training,
experience, current competence, and
judgment
316
H&P 358
Repeated in tag number 461 and 463 and in
surgery section
CMS changes standard to be consistent with TJC
standard
MS must adopt bylaws to carry out their
responsibilities on H&Ps
The bylaws must include a requirement that a
H&P be completed no more than 30 days before
or 24 hours after admission on each patient
Must be on chart before surgery
317
H&P Admission
There needs to be an updated entry in the
medical record to reflect any changes
Person who does the H&P must be licensed
and qualified
Example, family physician does H&P 2 weeks
ago for patient having CABG today
Surgeon would review, update, and
determine if any changes since it was done
and authenticate document
318
History and Physicals
Can include in progress notes or has stamp
sticker, check box, or entry on H&P form
Should say that H&P was reviewed, the
patient examined, and that “no change” has
occurred in the patient’s condition since the
H&P was completed
There needs to be a complete H&P in the
chart for every patient except in emergencies
and can make entry in progress notes
319
History and Physicals
New regulation expands the number of
categories of people who can do a H&P
If state law and the hospital allows (which
most do) a PA or NP may perform
Physician is still responsible for the contents
and must sign off the H&P when done by one
of these allied health professionals
Need to do PI to make sure all H&P are on the chart
especially when the patient goes to surgery
320
TJC PC.01.02.03 H&P
EP4 requires H&P no more than 30 days old and
done within 24 hours
EP5 if done within 24 hours update, update prior to
surgery (also RC.01.03.01)
EP7 that requires an update to a history and
physical (H&P) at the time of the admission
RC.02.01.03 EP3 document H&P in MR for
operative or high risk procedure and for moderate
and deep sedation
MS.01.01.01 requires H&P process be in MS
bylaws
321
TJC MS.03.01.01 H&P
EP6 Specifies minimal content (can vary by setting,
level of service, tx & services
EP7 MS must monitor the quality of the H&Ps
EP8 Medical staff requires person be privileged to
do H&P and requires updates
EP9 As permitted by state law, allow individuals who
are not LIPs to perform part or all of the H&P
EP10 MS defines when it must be validated and
countersigned by LIP with privileges
MS defines scope of H&P for non inpatient services
322
Autopsies 0364
MS should attempt to secure autopsies
in all cases of unusual deaths
Must define mechanism for
documenting permission to perform an
autopsy
Must be system for notifying MS and
attending doctor when autopsy is
performed
 TJC has similar section
323
Nursing Services 0385
 Must have an organized nursing service that provide 24 hour
nursing services
 Must have at least one RN furnishing or supervising 24
hours
 SSA at 1861 (b) states you must have a RN on duty at all
times (except small rural hospitals under a waiver)
 Survey procedures-determine nursing services is integrated
into hospital PI
 Make sure there is adequate staffing
 Survey procedure - look for job descriptions including
director of nursing
324
Director of Nursing Service
DON must be RN, A-386
 Often referred to as chief nursing officer or CNO
CNO responsible for determining types and
numbers of nursing personnel
CNO responsible for operation of nursing service
Survey procedure-look at organizational chart
May read job description of DON to make sure it
provides for this responsibility
May verify DON approves patient care P&P’s
325
Nurse Staffing 392
Nursing service must have adequate number
of nurses and personnel to care for patients
 Answer call lights timely and check on patient if cardiac
monitor alarms
Must have nursing supervisor
Every department or unit must have a RN
present (not available if working on two units
at same time)
Survey procedure-look at staffing schedules that
correlate number and acuity of patients
326
Nurse Staffing 392
There are 3 recent evidenced based studies
that show the importance of having adequate
staffing which results in better outcomes
Study said patients who want to survive their
new hospital visit should look for low nursepatient ratio
Nurse Staffing and Quality of Patient Care, AHRQ,
Evidence Report/Technology Report Number 151,
March 2007, AHRQ Publication No. 07-E0051
1http://www.ahrq.gov/downloads/pub/
evidence/pdf/nursestaff/nursestaff.pdf
327
Nursing Linked to Safety
IOM study also linked adequate staffing
levels to patient outcomes
Limits to number of hours worked to prevent
fatigue
Suggests no mandatory overtime for nurses
Never work a nurse over 12 hours or 60
hours in one week (or will have 3 times the
error)
328
Nursing Linked to Safety
Also showed medication error rate, falls,
pressure ulcers, UTI, surgery site infections,
gastric ulcers, codes, LOS, increased
unnecessary readmissions, patient
experience or satisfaction rates etc. linked to
staffing
 Important in value based purchasing
Redesigning the work force
See Keeping Patients Safe: Transforming the Work
Environment of Nurses 20041
1www.nap.edu/openbook/0309090679/html/23/html
329
Nursing Staffing Linked to Safety
AHRQ 2008 has published 3 volume, 51 chapter
handbook for nurses at no cost
Great resource that every hospital should have
Nurse Staffing and Patient Care Quality and
Safety
Again shows that patient safety and quality is
affected by short staffing
Patient Safety and Quality: An Evidence-Based
Handbook for Nurses, 20081
 1http://www.ahrq.gov/qual/nurseshdbk
330
Verify Licensure 394
Must have procedure to ensure nursing
personnel have valid and current license
Survey procedure-review licensure
verification P&P
Can verify licensure on line by most state
boards of nursing online
Considered primary source verification
Can print out information for employee file
331
RN for Every Patient 395
A RN must supervise and evaluate the
nursing care for every patient
RN must do admission assessment
Must use acceptable standard of care
Evaluation would include assessing
each patient’s needs, health status and
response to interventions
332
Nursing Care Plan 396
2013
Hospital must ensure that nursing staff develop and
keeps a current, nursing care plan for each patient
If nursing participates in interdisciplinary care
plan then do not have to have separate nursing
plan of care
Starts upon admission, includes discharge
planning, physiological and psychosocial factors
Based on assessing the patient’s needs
Care plan is part of the patient’s medical records
and must be initiated soon after admission, revised
and implemented
333
Agency Nurses 398
Agency nurses or traveling nurses (CMS calls
them non-employee nurses) must adhere to
P&P’s
CNO must provide adequate supervision and
evaluate (once a year) activities of agency
nurses
Includes other personnel such as volunteers
Orientation must include to hospital and to
specific unit, emergency procedures, nursing
P&P, and safety P&P’s
334
Preparation/Admin of Drugs 405
Drugs must be prepared and administered according
to state and federal law
 404 deleted and combined with 405
Need an practitioner’s order
 CMS changes to allow other practitioners who are allowed to order to
sign off order such as PharmD as allowed by P&P and state scope of
practice and MS bylaws/RR
Surveyor will observe nurse prepare and pass
medications
Medications must be prepared and administered with
acceptable national standards of practice (TJC MM
chapter), manufacturer’s directions and hospital policy
335
CMS Changes to Medication Administration
CMS issued a survey and certification memo
dated 11-18-11, 6-7-13 and March 14, 2014
 Tag 405 use to say that all medications
must be given within 30 minutes of the
scheduled time
 Now three blocks of time to give
medications
 Included section on standing orders but
most sections moved to tag 457
336
CMS Changes to CoPs 6-6-2014
 Changed tag 405 which deals with orders of drugs
and biologicals and safe opioid use
 Most sections on standing orders section was
moved to 457
 Added information on age and weight of patient
especially weight based doses for children
 All drugs are administered under the supervision of
nursing or other personnel
 Five rights of medication administration: right patient,
medication, dose, route and time and references nine
rights
337
Pharmacy Should Prepare Piggybacks & IVs
338
Administration of Meds 0405
Medication management is a hot topic with
CMS and TJC
All drugs administered under the supervision
of nursing or other personnel if permitted by
law
In accordance with approved medical staff
P&P’s, state & federal laws, MS bylaws and
R/R and scope of practice
Surveyor will review sample of medication
records to ensure it conforms to physician’s order
339
Administration of Meds 405
Need to have an order, make sure compliant
with state and federal laws, and acceptable
standards of practice
Need to have a P&P with three time frames on
timing of medications
Must educate staff and policy must comply with the
10 page memo issued
Include medications not eligible for scheduled
dosing such as stat drugs, PRN, loading doses,
drugs for scheduled procedure etc.
340
Administration of Meds 405
 Medications that are eligible for scheduled times
 P&P to include time-critical scheduled medications
given in 30 minutes with one hour window
 P&P that are non-time-critical scheduled
medications
 2 hours for medications prescribed more frequently than
daily, but no more frequently than every 4 hours and
 4 hours for medications prescribed for daily or longer
administration intervals
 P&P on missed or late medications
341
Assessment & Monitoring of Patients 2014
 Patients on medications needed to be carefully
monitored
 May need clinical and lab data to evaluate medication
 Monitor respiratory status, pulse ox BP, end tidal CO2
with patients on opioids
 Evaluate clinical signs such as confusion, agitation,
unsteady gait, itching etc.
 Know high risk medications policy and safe practices
 Know risk factors for ADE such as patient has liver or
kidney failure, history of sleep apnea, obesity, smoking,
drug-drug interaction and first time medication use
342
ISMP List of High Alert Medication
343
Assessment & Monitoring of Patients
 ADE, such as anaphylaxis or opioid-induced
respiratory depression may require timely and
appropriate
 Post-medication monitoring in case of a high alert
medication may include regular assessment of VS,
pulse ox, and sedation levels of post surgery patient
on PCA
 Such as Richmond agitation sedation scale (RASS)
or the Pasero Opioid-Induced sedation scale
(POSS), Inova Sedation Scale (ISS), Ramsey scale,
Aldrete Scoring system
344
Assessment & Monitoring of Patients
 Staff are expected to include patient reports of his
experience with medication’s effect
 Patient should be instructed to notify nurse if there
is difficulty breathing or a reaction to the medication
 Hospital needs P&P to address the manner and
frequency of monitoring
 P&P should include information to be
communicated at shift change
 Should include patient’s risk factors
 Document after medication administered
345
9 Rights of Medication Administration
346
Physician Order 406
Standard: Drugs and biologicals must be
prepared on the order contained within preprinted
and electronic standing orders, order sets, and
protocols if meet the standards in tag 457
Orders for drugs can be documented and signed
by other practices if acting in scope of practice,
state law, P&P, and MS bylaws and R/R
CMS issues standing order memo 10-24-08
Also includes standing orders, preprinted orders
and use of rubber stamps
347
Physician Order 406
Flu and pneumovax can be given by protocol
approved by the MS after assessment of
contraindications
Orders for drugs must be documented and
signed by practitioners allowed to write them
Doctors and if allowed NP and PAs
Rubber stamps - will not be paid for order for
M/M patients and some insurance companies
so many hospitals do not allow rubber
stamps
348
Physician Order 406
Order must have name of patient, age and weight
(if applicable), date and TIME of order, drug name,
strength, frequency, dose, route, quality and
duration, and special instructions for use, and name
of pre scriber
Have a culture so can ask questions
Now allowed to have written protocol or standing
orders with drugs and biologicals that have been
approved by MS
Can implement them but be sure provider signs,
dates, and times the order
349
Physician Order 406
Chest pain protocol or asthma protocol with
Albuterol and Atrovent are an example of
initiation of orders
Code teams gives ACLS drugs in an arrest
Timing of orders should not be a barrier to
effective emergency response
Preprinted order - should send memo so
doctors and providers are aware of new
guidelines
350
Preprinted Order Sets
Must date and time when the order set is signed
Must indicate on last page the total number of pages in
the order set
If want to strike out something in the order sheet or delete
it or add order on blank line then physician needs to initial
each place
Should add this to the MR audit sheet to make sure there
is compliance with this guideline
Standing orders must address well-defined clinical
scenarios involving medication
Refers to tag 457 and 450 for more information
351
Verbal Orders 407 and 408
Verbal orders are a patient safety issue
Have lead to many errors
Hospital must describe situations in which they can
be used as well as limitations
Must establish the identity and author of all orders
Rewrite your P&P and Medical staff by-laws to be
consistent with these standards
Repeated VO section in MR starting with tag 454 and
reiterated area of verbal orders offer too much room
for error
352
Verbal Orders
Must follow state law for time period to sign off
such as 24 or 48 hours
If no state law do not have to sign off in 48 hours
anymore
 Must sign off orders within time frame set by
hospital policy
 Many hospitals without a state law can choose
to have signed off in policy but
 But still try and get them signed off ASAP
 Must still sign name and date and time the order
353
CMS Verbal Orders
Emphasizes to be used infrequently and never for
convenience of the physicians
This means that physician should not give verbal
orders in nursing station if he or she can write them
Can be used in emergency or if surgeon is scrubbed
in during surgery
Regulation broadens category of practitioners who
can sign orders off such as PA or NP
Renewed any physician can sign off for any other
physician on the case
354
Verbal Orders P&P Should Include
Limitations or situation on not using VO such
as not for chemotherapy
List the elements for a complete VO (such as
patient name, drug, dose, frequency, name
of person giving and taking order, et al.)
Define who can receive VO and the method
to ensure authentication
Provide guidelines for clear and effective
communications
355
Signing Off Verbal Orders
Person taking VO must document it in the chart
Physician must sign off a verbal order, date, and
time it when signed off
Any physician on the case can sign off any VO
This practice must be addressed in the hospital’s
P&P
Now a NP or PA may sign off a verbal order, if
within their scope (where they had authority to
write order) and allowed by state law, hospital
policy and delegated to this by the physician
356
Verbal Orders
Regulation states that verbal orders should
be authenticated based on state law
Some states require order to be signed off
in 24 hours or 48 hour and if no state law
then no longer a set 48 hours but what your
hospital P&P dictate
Need hospital P&P to reflect these
guidelines
Write it down and repeat it back
357
Joint Commission Verbal Orders
RC.02.03.03 (IM 6.50) requires that qualified
staff receive and record VO
Define in writing who can receive and record
VO
Date and document identity of who gave,
received, and implemented the order
Authenticated within time frame law/regulation
Write it down and read back the completed
order or test result (NPSG 2009)
358
Blood Transfusions and IVs 409
Standard: Blood transfusions and IV
medications must be administered with state
law and MS P&P
Use to require special training for this and there was a
long list of things that nurses had to be trained on
 CMS eliminated the regulations mandating training for
non-physicians who administer IV medication and blood
and blood products
 CMS says because this training is already standard
practice but must still be competent in those areas
 Must follow your P&P and state scope of practice
359
Blood and IV Medication Training
Must still follow state law requirements
 In some states an LPN can not hang blood
 Or the LPN can not push certain IV medications
in some states
 Must show they are competent
Must still have approved Medical Staff
Policies and Procedures in place
Staff must follow these which have most of
the things that were previously required
360
Blood Transfusions and IVs
 Hospital P&P for blood and IV medication must be
based on state law and MS P&P and must address
the following:
 Vascular access route such as central line, peripheral
or implanted port and what medications can be given
IV and via what type of access devices
 Basic safety practices for medication
administration
– Tracing line and tubes prior to administration to be sure
proper route
– Verify proper programming of infusion devices
361
Blood Transfusions and IVs
 Patient Monitoring
 Monitor for the effects of the medication since IV
medications have a more rapid effect
 Monitoring to include assessment of risk factors that
would influence type and frequency of monitoring
 Such as patient with renal failure on Vancomycin and
dose is based on lab test
 P&P expected to address
 Monitoring for fluid and electrolyte balance
 Monitor patients on high alert meds including opioids and
evaluate for over-sedation and respiratory depression
362
Blood Transfusions and IVs
 Risk factors for patients receiving opioids include
 Snoring or history of sleep apnea
 No recent opioid use or first-time use of IV opioids
 Increased opioid dose requirement or opioid habituation
 Longer length of time receiving general anesthesia during
surgery
 Receiving other sedating drugs, such as benzodiazepines,
antihistamines, sedatives, or other CNS depressants
 Preexisting pulmonary or cardiac disease
 Thoracic or other surgical incisions that may impair
breathing
363
Blood Transfusions and IVs
 P&P must include who can conduct the
assessments
 The frequency and duration of the assessments
 Under what circumstances practitioners prescribing
IV opioids are allowed to establish protocols that
differ from hospital P&P
 Assessment includes VS (TPR and BP), pain level,
respiratory status, sedation level and ETCO2
 Also mentions APSF monitoring of opioids including
ETCO2
364
365
Blood Transfusions
 Confirm correct patient
 Verify correct blood product
 Standard calls for two qualified persons, one who is
administering the transfusion
 Document monitoring
 P&P include how frequent you monitor the patient
and do vital signs
 How to identify and treat and report any adverse
transfusion reaction
366
Blood Transfusions
Staff must be competent in venipuncture
Competent in using vascular access devices
Trained in early detection and intervention for
opioid over-sedation
Must document competency
So make sure nursing education is aware
and staff trained in orientation periodically
Make sure staff educated on P&P
367
Blood Transfusions and IVs
 Is there evidence that staff competent in;
 Maintaining fluid and electrolyte balance
 Venipuncture techniques
 Blood transfusion: blood components,
administration policy, national standards of practice,
patient monitoring requirements including
frequency, documentation, verifying correct blood
and patient
 Transfusion reactions; Identification, treatment and
reporting requirements
368
Incident Reports Transfusions
There must be procedure for reporting
transfusion reactions, adverse drug reactions
and errors in administration of drugs (410)
Survey procedure - request procedure for
reporting-they may review the incident reports or
other documentation through QAPI program
But must have a hospital P&P for reporting
transfusion reactions such as an incident reporting
system
 See tag number 508
369
ADE and Drug Administration 410
 Mentions similar standard in pharmacy section
which is in tag 508
 Wants to be all drug errors and ADE are reported
 This includes any blood transfusions AE
 Discusses symptoms of a transfusion reaction
 Need P&P for internal reporting of transfusion
reactions since be life threatening
 Must be immediately reported to the practitioner
responsible for the patient’s care and documented
in the medical record and report to PI
370
Self Administration of Medication 412
Standard: Hospital may allow a patient or
caregiver to self administer both hospital
issued medication and the medication the
patient brought from home
 As specified in the hospital P&P
 Revise your policy to include this section
 Add this to the education of your nursing and
pharmacy staff
371
Self Administration of Medication 412
Must have an order, must make sure patient
is competent to do, must educate the patient
P&P must address security of medication for
each patient
Must document in the MR so patient must let
nurse know
Visually inspect medication for integrity
Previously this section was in the pharmacy
section 502
372
Medical Record Services 432
Must have MR services and have an
administrator responsible for MR and will
sample 10% of daily census and at least 30
records
Must keep MR on every patient and have one
unified MR service responsible for all MR,
both inpatient and outpatient
MR includes radiology films and scans,
pathology slides, computerized information,
et al
373
Staffing of Medical Records 432
Organization must be appropriate for size and
must employ adequate personnel to ensure
prompt completion, filing, and retrieval
Must have proper education, skills,
qualifications and experience to meet state
and federal law
Ensure proper coding and indexing of records
Surveyor will look at job descriptions and
staffing schedules
374
Retention of Record 438
MR on each patient
Both inpatients and outpatients
MR must be accurate
Contains all orders, test results, care plans, treatment
and response to treatment), complete, retained and
accessible
Accessible 24 hours a day
Use a system of author identification and protect
security of all records
Protected from fire, water damage and other threats
375
Medical Records
Must be promptly completed
Kept at least 5 years (439) in other legal
reproducible manner
Certain medical records may be retained
longer if required by state or federal law
(OSHA, EPA, FDA)
 See retention law memo from AHIMA
 Will request records from 48-60 months ago
376
Retrieval 440
Must have a system of coding and
indexing that allows timely retrieval of
MR
Must be able to retrieve by diagnosis
and procedure to support medical care
studies
MR have to be accessible for
departments that need them like the
emergency department
377
Privacy & Confidentiality Memo 3-2-12 Tag 147
378
Privacy & Confidentiality Memo
 Discusses privacy & confidentiality consistent
with HIPAA
 HIPAA 526 pages of changes Sept 23, 2013
 Discusses incidental uses and disclosures
 Allows name on spine of chart
 Allows name on outside of patient room
 Allows signs such as fall risk or diabetic diet
 Will cover later in the presentation
379
Confidentiality 441
Standard: Must have a procedure for
ensuring confidentiality of MR
Hospital must ensure that unauthorized individuals
can not gain access to or alter the medical records
Copies may only be released to authorized
individuals and written authorization by
proper person, DPOA, guardian, etc.
Release original only for court orders, subpoenas but
usually will take a certified copy
Surveyor will ask for policy
380
Confidentiality 441
 Reiterated some of the things in tag 143 and 147
 Must have P&P to ensure confidentiality of the MR
 May use for payment or healthcare operations
without the patient’s authorization
 Financial, legal, PI, activities of the hospital to conduct
business and support core functions, case management,
audit, medical reviews, fraud and abuse detection, etc.
 P&P must limit disclose of MR to the minimum
disclosure necessary
 Surveyor will observe to make sure MR protected
381
Content of Records A-449
Contain records, notes, reports assessment to
justify
Admission
Continued hospitalization
Support the diagnosis
Describe the patient’s progress
Describe response to medications and to
interventions, care, and treatment
Records must be promptly filed in chart
382
Legible and Authenticated 450
All entries must be legible, complete, dated and
timed
Must be authenticated by the person responsible
for ordering, providing, or evaluating the service
provided
Specify in MS or hospital policy who can make entries
in medical record
Need method to identify author
 Written signatures, electronic signature, initials, computer
key, or other code and a list of written signatures must be
available
383
Legible and Authenticated
Must have P&P if electronic medical record
If non MD does H&P or document exams, must be
authenticated
MS R&R address countersignature when required
by policy or state law and this is defined in MS R&R
Section on standing orders (preprinted order sets)
 Sign, date, and time the last page
 Include total number of pages such as page 3 of 3
 Initial any changes, additions, or deletions
384
Medical Records 450
If rubber stamp used-must have signed statement
only that individual will use it, but do not allow for
signature or you may not be paid for care
Just don’t allow stamps for signatures on orders
 Also CMS issued in a separate Program Integrity manual
April 2010 stamps are not allowed
If electronic MR must demonstrate how alterations
are prevented
Can’t use system of auto authentication that says
can not review because not transcribed yet
385
CMS Signature Guidelines
 April 16, 2010 CMS issues new signature guidelines and
says no rubber stamps and also see billing manual
 CMS issued a change request updating the
Program Integrity Manual on signature guidelines
for medical review purposes
 Requires legible identifier in form of handwritten or
electronic signature
 Third exception is cases where national coverage
determination (NCD), local coverage determination
(LCD) or if CMS manual has specific guidelines
takes precedence over above
386
387
388
389
Verbal Orders 454 and 457
 Recall verbal order section starting in NS section at tag
number 407 and 408 is repeated and already discussed
 All doctor can sign VO for any other doctor on case or
practitioner responsible for care if within scope and state law
 Person who takes VO must read it back and write it down with
date and time
 When doctor or LIP authenticates and signs off order must date and
time it also and do asap such as next time doctor sees patient
 Sign off as required by state law and if no state law then as
required by your hospital P&P
 If state law says sign off in 24 or 48 hours you must follow
 If no state law then no longer 48 hours and many hospitals sign off
within P&P but must still sign off, date and time the entry and want to
sign off asap such as next time the physician sees the patient
390
Tag 457 Standing Orders
 Standard: hospitals can use preprinted and
electronic standing orders, order sets, and protocols
for patient orders only if the hospital has the
following 4 things:
 Make sure the orders and protocols have been
reviewed and approved by the Medical Staff (such
as the MEC) and the hospital’s nursing and
pharmacy leadership
 Demonstrate that the orders and protocols are
consistent with nationally recognized and evidenced
based guidelines
391
Tag 457 Standing Orders
 No standard definition of standing orders
 For brevity CMS uses standing orders to include
pre-printed orders, electronic standing orders, order
sets and protocols
 Said these are forms of standing orders
 States lack of standard definition may result in
confusion
 Not all preprinted and electronic order sets are
considered a standing order covered by this
regulation
392
Tag 457 Standing Orders
Example; doctor or qualified practitioner picks
from an order set menu and treatment
choices can not be initiated by nurses or
other non-practitioner staff then menus are
not standing orders covered by this regulation
Menu options does not create an order set
subject to these regulations
The physician has the choice not to use this
menu and could create orders from scratch or
modify it
393
Standing Order Requirements
457
 Must be well-defined clinical situations with
evidence to support standardized treatments
 Appropriate use can contribute to patient safety
and quality care
 Can be initiated as emergency response
 Can be initiated as part of an evidenced based
treatment regime where not practicable to get a
written or verbal order
 Must be medically appropriate such as RRT
394
Standing Order Requirements 457
 Triage and initialing screening to stabilize ED
patients presenting with symptoms of MI, stroke,
asthma
 Post-operative recovery areas like PACU
 Timely provisions of immunizations
 Can’t be used when prohibited by state or federal
law so no standing orders on R&S
 CMS has set forth a number of minimum
requirements for standing orders that must be
present for a well-defined clinical scenario
395
Minimum Requirements for Standing Orders
 Must be approved by MS, nursing and pharmacy
leadership
 P&P address how it is developed, approved,
monitored, initiated by staff and signed off or
authenticated
 Must have specific criteria identified in the protocol
for the order for a nurse or other staff to initiate
 Such as a specific clinical situation, patient condition or
diagnosis
 Must include process to have them signed off
396
Minimum Requirements for Standing Orders
 Hospital must document standing order is
consistent with nationally recognized and evidenced
based guidelines
 Burden is on the hospital to show there is sound
basis for the standing order
 Must have regular review to ensure its still useful
and a safe order
 P&P address how to correct it, revise or modify
 Must be placed in the order section of the chart
 Must be dated, timed, and signed
397
Tag 457 Standing Orders
 Make sure there is periodic and regular review of
the orders and protocols conducted by the MS,
nursing and pharmacy leadership to determine the
continued usefulness and safety
 Make sure they are dated, timed, and
authenticated promptly in the medical record
 Signed off by the ordering practitioner of another
practitioner on the case
 Could be signed off by non-physician if allowed by
hospital policy, state law, the person state law scope
of practice, and MS bylaws or R/R
398
History and Physical 458 and 461
Repeats same provisions on H&P as in
medical staff section under tag number 358
and 359
H&P done within 24 hours, not older than 30
days old and updated within 24 hours and
updated and on chart before patient goes to
surgery
PA and NP can do if allowed by hospital and all
state laws allow and physician reviews and
authenticates with date, time, and signature
399
MR Must Contain 464 and 465
Must have admitting diagnosis in chart (463)
All consults and findings by clinical staff and others
must be documented (464)
Information must be promptly filed in the MR so staff
has access to it (464)
Must document complications and healthcareassociated infections (HAI) and unfavorable
reactions to drugs and anesthesia (465)
It is important for all practitioners to be aware of the
need to document complications and how to do this
correctly
400
Informed Consent 466
Now three separate sections related to
informed consent in patient rights, medical
record and surgical services
Properly executed informed consent for
procedures and treatments specified by MS
Need list of all surgeries
As defined now by ACS and AMA
Listed procedures with yes or no
401
Informed Consent MR Mandatory
Minimum elements in an informed consent
Name of hospital
Name of procedure or treatment
Name of responsible practitioner who is
performing
Statement that benefits, material risks and
alternatives were explained
Signature of patient
Date and time form is signed
402
Medical Records 466
CMS has list of optional elements which they
call a well designed consent form
Medical record must contain an informed
consent for procedures and treatments
specified as requiring on and MS by-laws
should address this
Consider state laws requiring informed
consent such as for invasive procedures and
any federal laws such as informed consent
for research
403
Consider List of Procedures
Procedure Name
Requires Informed Consent
Ablations
Yes
Amniocentesis
Yes
Angiogram
Yes
Angiography
Yes
Angioplasties
Yes
Arthrogram
Yes
Arterial Line insertion (performed alone) Yes
Aspiration Cyst (simple/minor)
No
404
Consider List of Procedures
Procedure Name
Requires Informed Consent
Aspiration Cyst (complex)
Yes
Blood Administration
Yes
Blood Patch
Yes
Bone Marrow Aspiration
Yes
Bone Marrow Biopsy
Yes
Bronchoscopy
Yes
Capsule Endoscopy
Yes
405
Informed Consent Forms
Need for all surgeries
Exception is emergencies
All inpatients and outpatients
For all procedures specified
Needs to reflect a process
Form must follow policies
Must include state or federal requirements
Must contain minimum requirements (mandatory)
406
Medical Records
Medical record must contain an informed
consent for procedures and treatments
specified as requiring one
Medical staff by-laws should address this
Consider state laws requiring informed consent
such as for invasive procedures
Consider any federal laws such as informed
consent for research, and state laws on
informed consent
407
Well Designed (Optional)
Name of the practitioner who conducted the
informed consent discussion with the patient
or the patient’s representative
It is required to tell the patient this but
optional to put it in writing
Date, time, and signature of witness
Indication or listing of the material risks of the
procedure or treatment that were discussed with
the patient or the patient’s representative
408
Well Designed (Optional)
Statement, if applicable, that physicians other
than the operating practitioner, including but not
limited to residents, will be performing important
tasks related to the surgery, in accordance with
the hospital’s policies and, in the case of
residents, based on their skill set and under the
supervision of the responsible practitioner
Still have to inform patient if someone is doing
important parts of the surgery but having it in
writing is optional
409
Well Designed (Optional)
Statement, if applicable, that QMP who are
not physicians who will perform important
parts of the surgery
or administration of anesthesia will be
performing only tasks that are within their
scope of practice,
 as determined under State law and
regulation,
 and for which they have been granted
privileges by the hospital
410
Survey Procedure
Verify hospital has assured MS has list of
procedures and treatments that require
consent
Verify informed consent forms six mandatory
elements
Compare the hospital standard informed
consent form to the P&Ps to make sure
consistent
Make sure any state law requirements are
included
411
Chart Must Contain 467
Medical record must contain all orders,
nursing notes, reports, medication records,
radiology, lab reports, and vital signs
Orders must be authenticates or signed off
All reports of treatment which includes
complications
Any other information used to monitor the
patient’s condition
412
Discharge Summary 468
All medical records must have a discharge
summary with outcome of hospitalization
Disposition of the patient
Provisions for follow up care
Follow-up care includes post hospital
appointments, how care needs will be met, and
any plans for home health care, LTC, hospice or
assisted living
Can delegate to NP or PA if allowed by state law but
physician must authenticate and date it and time it
413
Final Diagnosis 469
Every medical record has to have a final
diagnosis
Medical records must be completed
within 30 days (same as TJC)
NQF 2010 34 Safe Practices recommends
discharge summaries be dictated at
discharge and sent promptly to PCP
Includes inpatient and outpatient charts
414
Pharmaceutical Services 490
Hospital must have a pharmacy to meet
the patient’s needs and need to promote
safe medication use process
Must be directed by registered pharmacist or
drug storage area under constant supervision
MS is responsible for developing P&P to
minimize drug error
Function may be delegated to the pharmacy
service
415
Pharmacy 490
Provide medication related information to
hospital personnel
Medication Management is important to CMS
and TJC and TJC has a medication
management chapter
Contains list of functions of the pharmacist
Collect patient specific information, monitor
effects, identify goals, implement monitoring plan
with patient, et.al.
Flag new types of mistakes
416
Pharmacy Policies Include:
High alert medication-dosing limits-packaging,
labeling and storage (policy at www.wpsi.org and
ISMP (Institute for Safe Medication Practice) and
USP have list of high alert medications)
Limiting number of medication related devices
and equipment-no more that 2 types of infusion
pumps (490)
Availability of up to date medication information
Pharmacist on call if not open 24 hours
417
Pharmacy Policies
Avoid dangerous abbreviations
All elements of order; dose, strength, route, units,
rate, frequency
Alert system for sound alike/look alike (LASA)
Use of facility approved pre-printed order sheets
whenever possible
“Resume pre-op orders” is prohibited
Voluntary, non-punitive reporting system to monitor
and report adverse drug events
418
Pharmacy Policies
Preparation, distribution, administration and
disposal of hazardous medications (chemotherapy)
 Drug recall
Patient specific information that should be readily
available
 TJC tells you exactly what this is, like age, sex, allergies,
current medications, etc.
Means to incorporate external alerts and
recommendation from national associations and
government for review and policy revision (Joint
Commission, ISMP, FDA, IHI, AHRQ, Med
Watch, NCCMER, MEDMARX)
419
Pharmacy Policies 490
Identification of weight based dosing for
pediatric populations
Requirements for review based on facility
generated reports of adverse drug events
and PI activities
Policy to identify potential and actual adverse
drug events (IHI trigger tool, concurrent
review, observe med passes etc.)
Must periodically review all P&P’s
420
Pharmacy Policies Include
Need a multidisciplinary committee committee of medicine, nursing,
administration, and pharmacy to develop
P&P
MS must develop P&P or have policy that
this function is fulfilled by pharmacy
Surveyors will make sure staff is familiar with
all the medication P&P’s
Need policies to minimize drug error
421
Pharmacy Management 491
Pharmacy or drug storage must be administered
in accordance with professional principles (TJC
03.01.01 and problematic standard)
This includes compliance with state laws
(pharmacy laws), and federal regulations (USP
797), standards by nationally recognized
organizations (ASHP, FDA, NIH, USP, ISMP,
etc.)
Pharmacy director must review P&P periodically
and revise
422
Pharmacy Management 491
Drugs stored as per manufacture’s
instructions; refrigerate, freeze, room
temperature, keep out of light etc.
Pharmacy employees provide services
within the scope of their licensure and
education
Sufficient pharmacy records to follow flow
from order to dispensing/administration
Maintain control over floor stock
423
Pharmacist 491
Ensure drugs are dispensed only by
licensed pharmacist
Must have pharmacist to develop,
supervise, and coordinate activities of
pharmacy
Can be part time, full time or consulting
Single pharmacist must be responsible
for overall administration of pharmacy
424
Pharmacist 491
Job description should define development,
supervision, and coordination of all activities
Must be knowledgeable about hospital
pharmacy practice and management
Must have adequate number of personnel to
ensure quality pharmacy service, including
emergency services
Sufficient to provide services for 24 hours, 7
days a week
425
Pharmacy Delivery of Service 500
Keep accurate records of all scheduled drugs
Need policy to minimize drug diversion
Drugs and biologicals must be controlled and
distributed to ensure patient safety
In accordance with state and federal law and
applicable standards of practice
Accounting of the receipt and disposition of drugs
subject to COMPREHENSIVE DRUG ABUSE
PREVENTION AND CONTROL ACT OF 1970
426
Delivery of Service 500
Pharmacist and hospital staff and committee
develop guidelines and P&P to ensure control and
distribution of medications and medication devices
System in place to minimize high alert medication
(double checks, dose limits, pre-printed orders,
double checks, special packaging, et.al.)
And on high risk patients (pediatric, geriatric, renal
or hepatic impairment)
High alert meds may include investigational,
controlled meds, medicines with narrow therapeutic
range and sound alike/look alike
427
Delivery of Service 500
All medication orders must be reviewed by a
pharmacist before first dose is dispensed
Includes review of therapeutic appropriateness of
medication regime
Therapeutic duplication
Appropriateness of drug, dose, frequency, route and
method of administration
Real or potential med-med, med-food, med-lab test,
and med-disease interactions
Allergies or sensitivities and variation from
organizational criteria for use
428
Delivery of Service 500
Sterile products should be prepared and labeled in
suitable environment
Pharmacy should participate in decisions
about emergency medication kits (such as
crash carts)
 Medication stored should be consistent with
age group and standards (such as pediatric
doses for pediatric crash cart)
Must have process to report serious adverse drug
reactions to the FDA
429
Delivery of Service 500
 Policy to address use of medications brought in
 P&P to ensure investigational meds are safely controlled and
administered
 Medications dispensed are retrieved when recalled or
discontinued by manufacturer or FDA (eg. Darvocet N)
 System in place to reconcile medication that are not
administered and that remain in medication drawer when
pharmacy restocks
 Will ask why it was not used?
 Not the same as medication reconciliation as in the TJC
NPSG which all hospitals should still do from a patient safety
perspective although in worksheets mentions this
430
Compounding of Drugs 501
All compounding, packaging, and disposal of
drugs and biologicals must be under the
supervision of pharmacist
Must be performed as required by state of federal
law & compounding law passed in 2013
Staff ensure accuracy in medication
preparation
Staff uses appropriate technique to avoid
contamination
431
Compounding of Drugs
Use a laminar airflow hood to prepare any IV
admixture, any sterile product made from non-sterile
ingredients, or sterile product that will not be used
within 24 hours (see USP 797)
Meds should be dispensed in safe manner and to
meet the needs of the patient
Quantities are minimized to avoid diversion,
dispensed timely, and if feasible in unit dose
All concerns, issues, or questions are clarified
with the individual prescriber before dispensing
432
Locked Storage Areas 502
Drugs and biologicals must be kept in a
secure and locked area
Would be considered a secure area if staff
actively providing care but not on a weekend
when no one is around
Schedule II, III, IV, and V must be kept locked
within a secure area (see also 503)
Only authorized person can get access to
locked areas
433
Locked Storage Areas 502
Persons without legal access to drugs and
biologicals can have not have unmonitored access
They can not have keys to storage rooms, carts,
cabinets or containers with unsecured medications
(housekeeping, maintenance, security)
Critical care and L&D area staffed and actively
providing care are considered secure
Setting up for patients on OR is considered secure
such as the anesthesia carts but after case or when
OR is closed need to lock cart
434
Securing Medications
So all controlled substances must be locked
Hospitals have greater flexibility in determining
which non controlled drugs and biologicals must
be kept locked
Medications should not be stored in areas readily
accessible to unauthorized persons such in a
private office unless visitors are not allowed
without supervision of staff
P&P need to address security of any carts
containing drugs
435
Securing Medications
CMS made changes in the FR effective June 2013 to
match the interpretive guidelines (See 412 & 413)
May allow patients to have access to urgently needed
drugs such as Nitro and inhalers
Need P&P on competence of patient, patient education
and must meet elements in TJC MM standard on self
administration
Measures to secure bedside medications
Document when patient reports the medication was
taken
Inspect the integrity of the medication
436
Locked Storage Areas
Saline flushes need to be secure to prevent
tampering so under constant supervision or locked
up (FDA does not consider as medication now)
 Consider having safe injection practices P&P and follow
CDC 10 guidelines such as one needle, one syringe
If medication cart is in use and unlocked, then
someone with legal access must be close by and
directing monitoring the cart, like when the nurse is
passing meds
Need policy for safeguarding, transferring and
availability of keys
437
Policy and Procedure
CMS states that they expect hospital P&P to
address
The security and monitoring of any carts
including whether locked or unlocked if
contains drugs and biologicals
In all patient care areas to ensure safe
storage and patient safety
P&P to keep drugs secure, prevent
tampering, and diversion
438
TJC Self Administered Meds
Self administered medications are safely and
accurately administered
If you allow self administration, need
procedure to manage, train, supervise, and
document process
TJC MM stands for medication management
standard MM 5.20 or MM.06.01.03
CMS mentions this standard in the FR when
changes were made and said to follow
439
TJC Self Administered Meds
If non-staff member administers (patient or
family) must train and make sure competent
to do so (give info on nature of med, how to
administer, side effects, and how to monitor
effects)
Patient has to be determined to be
competent before allowed to self administer
Mentioned TJC in Federal Register but not
in IG
440
Outdated or Mislabeled Drugs 505
Outdated, mislabeled or otherwise unusable
drugs and biologicals must not be available
for patient use
Hospital has a system to prevent outdated or
mislabeled drugs
Surveyor will spot check individual drug
containers to make sure have all the required
information including lot and control number,
expiration date, strength, etc.
441
No Pharmacist on Duty 506
If no pharmacist on duty, drugs removed from
storage area are allowed only by personnel
designated in policies of MS and pharmacy
service
Must be in accordance with state and federal law
Routine access to pharmacy by non-pharmacist for
access should be minimized and eliminated as much
as possible
E.g. night cabinet for use by nurse supervisor
Need process to get meds to patient if urgent or
emergent need
442
No Pharmacist on Duty 506
TJC does not allow nurse supervisor in pharmacy
so would need to call the on call pharmacist
Access is limited to set of medications that has
been approved by the hospital and only trained
prescribers and nurses are permitted access
Quality control procedures are in place like second
check by another or secondary verification like bar
coding
Pharmacist reviews all medications removed and
correlates with order first thing in the morning
443
Medications Errors 508 5-20-11
Drug errors, adverse drug reaction, and drug
incompatibilities must be immediately reported to
the attending physician and to the hospital PI
program
Definition of med error or ADE should be broad
enough to include NEAR MISSES
Recommend use of the broad definition by National
coordinating council medication error reporting and
prevention definition and ASHP definition of ADR
 Will make sure definition is based on national standards
Must have a P&P for reporting
444
Medications Errors 508 2013
 Must be documented in the medical record and
reported to QAPI program
 CMS encourages non-punitive approach
 Hospital can not just rely on incident reports but
must take step to identify these events
 Need to measure the effectiveness of systems to
identify and report to the PI program which includes
benchmarks and RCA when indicated
 Encouraged to externally report to FDA MedWatch
program, ISMP medication error reporting program
etc.
445
Medications Errors 509
Hospital must proactively identify med errors
and ADE and can not rely solely on incident
reports
Proactive includes observation of med passes,
concurrent and retrospective review of patient’s
clinical record, ADR surveillance, evaluation of high
alert drugs and indicator drugs (Narcan,
Romazicon, Benadryl, Digibind, et al) or generate a
review for potential ADE
Remember FMEA (failure mode and effect analysis)
and IHI adverse event trigger tool is great
446
Abuses and Losses 509
Abuses and losses of controlled substances
must be reported pharmacist and CEO and in
accordance with any state or federal laws
Surveyor will interview pharmacist to
determine their understanding of controlled
substances policies
What is procedure for discovering drug
discrepancies?
447
Drug Interaction Information 510
Information on drug interactions and
information on drug side effects, toxicology,
dosage, indication for use and routes of
administration must be available to staff
Texts and other resources must be available
for staff at nursing stations and drug storage
areas
Staff development programs on new drugs
added to the formulary and how to resolve drug
therapy problems
448
Formulary 511
Formulary system must be established by the MS to
ensure quality pharmaceuticals at reasonable cost
Formulary lists the drugs that are available
Processes to monitor patient responses to newly
added medication
Process to approve and procure meds not on the
list
Process to address shortages and outages
including communication with staff, approving
substitution and educating everyone on this, and
how to obtain medications in a disaster
449
Radiology
 CMS issues a survey memo May 15, 2015 rewriting
the radiology and nuclear medicine standards
 41 pages memo and make sure radiology
department directors and radiologists have a copy of
this and went into effect July 2015
 Written to address issue of that ionizing radiation
can cause cancer and services are not without risk
 X-rays, CT, & fluoroscopy can damage DNA
 Revises radiology tag numbers 528, 529, 535, 536, 537,
538, 539, 546, 547, 553
 Deleted radiology tag numbers 545, 554, & 555
450
CMS Rewrites Radiology and Nuclear Med
451
Radiology
 Patient exposure to ionizing radiation has doubled in
20 years
 Due to diagnostic imaging, CT, fluoroscopy, and nuclear
medicine (NM) studies
 Amount of ionizing radiation from CT scan is significantly
greater and patient may receive several over their lifetime
 80 million studies done every year
 FDA has taken initiative to reduce unnecessary
radiation exposure
 Want to make sure it justified to use it and dose optimization so
lowest dose is used (as low as reasonably achievable)
452
Radiology
Changes discuss safety precautions a
hospital should do to decrease radiation
exposure such as:
 Need to identify high risk patient for whom a
diagnostic study might be contraindicated
 Use appropriate shielding of patients and staff that
is specific to the type of imaging device
 Periodically inspect and calibrate the equipment
 Make sure staff are appropriately trained
453
FDA Reduce Unnecessary Radiation Exposure
www.fda.gov/RadiationEmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.
htm
454
Radiology 528 2015
Standard: Must have diagnostic radiology
services which must meet professional
standards for safety and staff qualifications
 Such as to diagnosis a fracture or presence
of a tumor
If provides therapeutic services must also
meet these standards
 Such as treating a problem such as stenting
an artery or lithotripsy of a kidney stone
455
Radiology 528
Must have P&P for radiology safety and to
make sure all staff are qualified
Consider one unified radiology services no
matter where performed through out the
hospital under the direction of a radiologist
Explains different tests such as CT scans,
DEXA scans, x-rays, fluoroscopy, radiation
therapy (external bean therapy,
brachytherapy), ultrasound, MRI, etc.
456
Radiology 529 2015
 Standard: Hospital must have radiology
services to meet needs of patients
 Needs to have diagnostic radiology services
on site to meet the patient’s needs based on
volume and types of patients served
 Must be available at all times on campus or
nearby
 Can be performed by hospital and hospital
staff or through contracted services
457
Radiology 529 2015
 Scope and complexity of your diagnostic services
must be in writing
 Therapeutic radiology services are optional
 Can use teleradiology
 Surveyor may ask how the hospital has determined
the needs of its patients
 Surveyor will make sure diagnostic radiology
service is provided promptly when needed
 If ED will make sure diagnostic services are
available at all times
458
Radiology 2015
535
 If therapeutic services are provided must meet
approved standards for safety (535)
 Radiology services, especially ionizing radiology
procedures, must be free from hazards to both
patients and staff
 Need P&P to ensure safety and that acceptable
standards are met
 X-rays can cause cataracts, skin damage, & cancer
 MRIs don’t use ionizing radiation but can cause
burns, adverse events, risk of flying magnetic items
459
Safety
 Proper safety precautions maintained against
radiology hazards (535)
 Including shielding for patients and personnel as
well as storage, use, and disposal of radioactive
materials (536)
 Need order of practitioner with privileges or
practitioners outside the hospital who have been
authorized by MS to order as allowed by state law
 Period inspection of equipment and fix any hazard
(537)
 Check radiation workers by use of badge tests or
exposure meters (538)
460
Radiology 2015
535
All radiology services must be provided in
accordance with the acceptable standard of
practice
 An example is the ACR standards on MRI safety
 CMS mentions FDA, AMA, ACR, Radiological
Society of North America, Alliance for Radiation
Safety in Pediatric Imaging, American Society of
Radiologic Technologist, ACC, American College
of Physicians and American College of Neurology
Must comply with all state and federal laws
461
Radiology 535 2015
 P&P must include:
 Principle of as low as reasonably achievable
(ALARA) which is defined by the EPA
 Written protocols used or approved by radiologist
to ensure studies are performed safely and
according to specifications
 Must identify patients at high risk of an adverse
event; pregnant, allergic to contrast, implanted
devices
 Requirements to mitigate radiation hazards
462
Radiology 535 2015
 P&P must include (continued):
 Procedures to address risks associated with MRI
and many other things that must be in the MRI
P&P
 Training required by staff to enter area where
services are provided
 Make sure staff are trained and competent including
training on P&P and how to operate the equipment
 How to respond to an emergency and must have
emergency equipment such as crash cart
463
Radiology 535 2015
 Surveyor will check to see you have all P&Ps
 Suggest use of physicists to make sure equipment
is calibrated and in good working order
 Hospital must monitor the quality and safety of
radiology services
 Proper patient preparation such as IV access
 Repeat studies of same patient may be indicator of poor
image quality
 There are a number of blue boxes which are
advisories or recommendations
464
Follow EPA’s Guidance on Radiation Doses
465
Radiology 2015
 Need proper safety precautions against radiation
hazards (536)
 Such as adequate shielding for patients and staff
 Appropriate storage and disposal of radioactive materials
 Need periodic inspection of equipment (537)
 Make sure hazards identified correctly
 Need P&P to make sure equipment is periodically
inspected and calibrated
 Follow manufacturers instructions
 Make sure exposure badges are used
466
Radiology 2015 538
 Radiation workers must be checked periodically for
amount of radiation exposure (538)
 Such as exposure meters or badge tests
 Identify in policy who has to wear
 Identify in policy types and location of staff exposed
to radiation and could include nursing
 Staff must be trained in proper use of badges
 Policies must be approved by the radiologist
 Surveyor may ask what you do when staff exposure
exceeds parameters
467
Radiology 2015
Need an order for radiology service (539)
Medical Staff and Board decide who can
order
Must have a qualified radiologist to supervise
the ionizing radiology services (546)
Must only interpret those tests determined to
require a radiologist’s specialized knowledge
468
Radiology 2015
Only qualified personnel may use radiology
equipment (547)
 Such as radiologist or radiology tech
Ensure reports are signed by the practitioner
who interpreted them (553)
Records must be maintained for at least 5
years of copies of reports , films, scans,
digital files, and printouts (553)
469
Radiology Records
 Radiology records must be maintained for all
procedures performed (553)
 Must contain copies of all reports and printouts
and any films, scans, or other image records
 Radiologist or other practitioner who performs
radiology services must sign the report of his
or her interpretation
 Surveyor to determine which staff are using
which piece of equipment and if qualified
470
Laboratory Services 576
 Must have adequate lab services to meet the
needs of the patient
 All lab services must in any hospital
department has to meet these guidelines
 All services must be provided in accordance
with CLIA requirements (Clinical Laboratory
Improvement Act) and have CLIA certificate
 Can provide lab services directly or as
contracted service
471
Lab Services
 All lab services, including contracted services,
must be integrated into hospital wide PI
 Lab results are considered medical records and
must meet all MR CoPs
 Must have lab services available either directly
or indirectly
 Must meet needs of its patients and in each
location of the hospital
 TJC has lab standards also
472
Emergency Lab-Services Available 583
 Must provide emergency lab services 24 hours a
day, 7 days a week - directly or indirectly (contracted)
 Hospital with multiple campuses must have available
24/7 at each campus
 MS must determine what lab tests will be
immediately available
 Should reflect the scope and complexity of the
hospital’s operations
 Written description of emergency lab services available
 Written description of test available are provided to MS on
routine and stat basis
473
Tissue Specimens 584
 Written instructions for the collection,
preservation, transportation, receipts, and
reporting of tissue specimen results
 MS and pathologist determine when tissue
specimens need macroscopic (gross) and
microscopic examination
 Need written policy on this
 TJC has a chapter on transplant safety and FAQs
474
Blood Banks 592
 Potentially infectious blood and blood
components
 This section completely rewritten so have
person in charge of P&P in this area and the
look back program to review these changes
 Will need to update P&Ps
 TJC has similar sections in transplant safety
chapter starting with TS.01.01.01 through
TS.03.03.01 and PC chapter for blood and blood
components
475
Blood and Blood Components
 Potentially HIV infectious blood and hepatitis C virus
(HCV) and blood products are collected from a donor
who tests negative
 If on a later donation tests positive then more specific
test or follow up testing is done as required by FDA
 If services provided by outside blood collecting
establishment (blood bank) then need agreement to
govern procurement, transfer and availability of blood
and blood products
 Agreement with blood bank must require blood bank
to notify hospital promptly (HIV and added HCV)
476
Blood Banks 592
 Time depends on if tested positive on this unit or
tested negative but on later donation tested positive
 Within 3 calendar days if blood tested is positive
later
 Follow up of notification within 45 calendar days
after reactive screening test was positive for
additional tests
 See look back procedures required by 21 CFR
610.45 et seq. and FDA regulations
 Hospital will dispose any contaminated blood from
donor if not given (TJC PC.05.01.01)
477
Patient Notification
 If administered potentially HIV/HCV infected
blood hospital must make reasonable
attempts to notify patient over period of 12
weeks unless patient already notified or
unable to locate in 12 weeks
 Records of the source and disposition of all
units of blood and blood components must
keep records ten years
478
Patient Notification
 A fully funded plan to transfer these records
to another hospital if the hospital closes (TJC
PC.05.01.05 maintains records on receipt,
testing and disposition of all blood and blood
components and fully funded plan to transfer
records to another organization if hospital
ceases operation for any reason)
 Must have P&P that meet federal and state
laws on notification of patients
479
Patient Notification
 Must document in MR
 Must conform to confidentiality requirements
 Must have 3 things in the content of the notice;
explanation of need for HIV and HCV testing and
counseling
 Enough written or oral information so can make an
informed decision
 List of programs where can get counseled and
tested
 If minor or incompetent or deceased then notify legal
representative
480
Food and Dietetic Services 618
 Hospital must have organized dietary services
 Must be directed and staffed by qualified
personnel
 If contract with outside company need to have
dietician and maintain minimum standards and
provide for liaison with MS on recommendations
on dietary policies
 Dietary services must be organized to ensure
nutritional needs of the patient are met in
accordance with physician orders and acceptable
standard of practice
481
CMS Changes
Interpretive guidelines effective April 2015
with changes to 628 (deleted), 629 and 630
Several are important to the CMS dietary
CoPs
Would permit registered dietitians or
nutritional specialist to order patient diets
independently, which they are trained to do,
without requiring the supervision or approval
of a physician or other practitioner when C&P
482
CMS Changes Food & Dietetic Services
 CMS said it came to their attention that CMS CoPs
were too restrictive and lacked the flexibility to allow
hospitals to extend privileges to RD (Registered
Dietician) in accordance with state law
 CMS believes RD are best qualified to assess
patient’s nutritional treatment plan and design and
implement a nutritional treatment plan in consult with
the care team
 Used the term RD but noted that not all states call
them RD and some states call them licensed
dieticians (LD) and some states recognize other
qualified nutrition specialists
483
CMS Changes Food & Dietetic Services
 CMS includes a qualified dieticians ( such as a RD)
as a practitioner who may be privileged to order
patient diets (Enteral and parenteral nutrition,
supplemental feedings and therapeutic diets) or
order related lab tests
 CMS said this would free up time for physicians and
other practitioners to care for patients
 Dietician or nutritional specialist can be granted
nutrition ordering privileges by the Medical Staff
(MS)
 This can be with or without appointment to the MS
484
Dietary Policies Required 618
 Need the following 7 policies:
 Availability of diet manual and therapeutic diet
menus
– Sometimes called Nutrition Care Manual (NCM) or Pediatric Nutrition Care
Manual (PNCM)
 Frequency of meals served
 System for diet ordering and patient tray delivery
 Accommodation of non-routine occurrences
– Parenteral nutrition (tube feeding), TPN, peripheral
parenteral nutrition, changes in diet orders, early/late
trays, nutritional supplements etc.
485
Seven Dietary Policies Required 618
 Integration of food and dietetic services into
hospital wide QAPI and infection control
programs
 Guidelines on acceptable hygiene practices
of personnel
 Guidelines for kitchen sanitation
 Important to protect against germs and bacteria that
cause illness
 Compliance with state or federal laws
486
Organization 620
 Must have full time director who is responsible
for daily management of dietary services
 Must be granted authority and delegation by the
Board and MS for the operation of dietary
services
 Job description should be position specific and
clearly delineate authority for direction of food
and dietary services
 Includes training programs for dietary staff and
ensuring P&Ps are followed
487
Dietary Policies
 Safety practices for food handling
 Emergency food supplies
 Orientation, work assignment, supervision of
work and personnel performance
 Menu planning
 Purchase of foods and supplies
 Retention of essential records (cost, menus,
training records, QAPI reports)
 Service QAPI program
488
Dietitian 621
 Qualified dietician must supervise nutritional aspects
of patient care and approve patient menus and
nutritional supplements
 Patient and family dietary counseling
 Perform and document nutritional assessments
 Evaluate patient tolerance to therapeutic diets when
appropriate
 Collaborate with other services (MS, nursing,
pharmacy, social work)
 Maintain data to recommend, prescribe therapeutic
diets
489
Personnel 622
 Must have administrative and technical
personnel competent in their duties
 Menus must be nutritional, balanced, and
meet special needs of patients
 Screening criteria should be developed to
determine what patients are at risk
 Once patient is identified nutritional assessment
should be done (TJC PC.01.02.01)
 Patient should be evaluated
490
Diets
628 Deleted 2015
 Menus must meet the needs of the patient
 Menus must be nutritional, balanced
 Menus must meet the special needs of patients
 Current menus should be posted in the kitchen
 Screening criteria should be developed to
determine what patients are at risk
 Once patient is identified nutritional assessment should be
done (TJC PC.01.02.01)
 Patient should be re-evaluated as necessary to ensure
their nutritional needs are met
491
CMS Rewrites Tag 629
492
Dietary Services
2015
 The IOM’s Food and Nutrition Board’s DRI or
Dietary Reference Intake 4 reference values
includes:
 RDA or the recommended dietary allowance is
average dietary intake of a nutrition sufficient of
healthy people
 Adequate Intake (AI) for a nutrient is similar to the
ESADDI and is only determine when an RDA can be
determined
– Estimated Safe and Adequate Daily Intake (ESADDI)
– AI is based on observed intakes of the nutrient by a group of healthy
persons
493
Dietary Services 2015
 IOM’s Food and Nutrition Board’s DRI or Dietary
Reference Intake 4 reference values (continued)
 Tolerable Upper Intake Level (UL) is highest
daily intake of a nutrient that is likely to pose
no risks of toxicity for most people
–As the UL increase, risk increases
 Estimated Average Requirement (EAR) is the
amount of the nutrient that is estimated to
meet the requirement of half of the health
people
494
IOM DRI or Dietary Reference Intake
http://fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes/dri-nutrient-reports
495
496
Dietary Guidelines for Americans
497
Watch for Changes in 2015
http://www.health.gov/dietaryguidelines/
498
499
Interactive DRI Tool and Tables
500
Therapeutic Diet 629
2015
Therapeutic diets may help meet the patient’s
nutritional needs
Assess patients for risk of nutritional
deficiencies
Therapeutic diets refer to a diet ordered as
part of the patient’s treatment for a disease or
clinical condition, to eliminate, decrease, or
increase certain substances in the diet(e.g.,
sodium or potassium), or to provide
mechanically altered food when indicated
501
Therapeutic Diet 629
2015
Patients must be assessed to determine if
they need a therapeutic diet for other
nutritional deficiencies
 Include in patient’s care plan
 Include the need to monitor intake
 Include if need daily weights, I&O, or lab values
Nursing does an admission assessment
which includes a nutritional screen
 These are good things to determine the patient’s risk and if
a dietary consult is needed
502
Nutritional Assessment Includes
 Patient May Need Comprehensive Assessment if:
 Medical or surgical conditions or physical status
interferes with their ability to digest or absorb
nutrients
 Patient has S&S indicating risk for malnutrition
–Anorexia, bulimia, electrolyte imbalance,
dysphagia, ESRD or certain medications
 Patient medical condition adversely affected by
intake and so need a special diet
–CHF, renal disease, diabetes, etc.
503
Dietary 2015
Patient May Need Comprehensive
Assessment if (continued):
 Patient receiving artificial nutrition
 Tube feeding, TPN, or peripheral parenteral nutrition
 Need an order for diets, including therapeutic
diet, from practitioner responsible for care
 Dietician or qualified nutritional specialist can be
C&P to order diet as consistent with state law
requirement
504
Therapeutic Diet 629
2015
 Patients who refuse food should be offered
substitutes of equal nutritional value in order to
meet their basic nutritional needs
 Surveyor will ask dietician how the menus and
nutritional needs of patient are being met such as
rely on DRIs, including RDA, in developing menus
 Will ask how patients are monitored who are identified as
having specialized needs
 Will look for order for therapeutic diet
 Will look at sample of patient records of patients
identified with special nutritional needs
505
Diet Order Needed 630
2015
 Standard: Need an order for all patient diets
including therapeutic diets
 Must be by practitioner responsible for care
(doctor, PA, NP) or qualified dietician or qualified
nutritional professional
 Must be authorized in the medical staff bylaws
 Must be consistent with state law
 A few states hold it against state law for a
dietician to prescribe a therapeutic diet
506
Patient Diets New Tag 630 2015
507
Diet Order Needed 630
2015
 Diets must be based on an assessment of the
patient’s nutritional and therapeutic needs
 Must be documented in the medical record
 Including patient’s tolerance to the therapeutic
diet
 Patient has a new diagnosis of CHF and put on a 2 gram
low sodium diet and losses weight because she does not
like the taste of the food without salt
 Board may permit the medical staff to grant
privileges to dieticians or nutritional professionals
508
Diet Order Needed 630
2015
 Many states have a specific statute that determines
when someone is a qualified dietician
 Registered dietician may be defined to include one
who is registered with Commission on Dietetic
Registration or state law
 Terms such as “nutritionists,” “nutrition
professionals,” “certified clinical nutritionists,” and
“certified nutrition specialists” are also used to refer
to individuals who are not dieticians, but who may
also be qualified under State law to order patient
diets.
509
Diet Order Needed 630
2015
 Hospital must make sure person is qualified before
appointing them to the medical staff or C&P
 If the hospital decides not to C&P, even if that
state’s law allows it, the patient must have a diet
ordered by the practitioner responsible for the
patient’s care
 If not C&P the person can still do a nutritional
assessment and make recommendations
 Surveyor will make sure diet is ordered and if
dietician writes orders is C&P whether appointed to
the medical staff or not
510
Nutritional Needs Survey Procedure 630
 Surveyor is suppose to ask the hospital to
show them what national standard they are
using
 Surveyor to view patient medical records to
verify diet orders are provided as prescribed by
the practitioner
 Surveyor is to determine if patient’s nutritional
needs have been met
 Will determine if dietary intake and nutritional
status is being monitored
511
Utilization Review 652
 Hospital must have a UR plan that provides for
review of services furnished by the institution and
the members of the MS to Medicare and Medicaid
beneficiaries
 UR plan should state responsibility and authority of
those involved in the UR process
 Surveyor will make sure activities performed as in
UR plan
 UR important to determine medical necessity
especially with increased RACs
 CMS issue UR CoP Memo June 22, 2007
512
Composition of UR Committee 654
 Consists of 2 or more practitioners who carry
out UR function
 At least 2 members must be doctors
 The UR committee must be either a staff
committee of the hospital or an group
outside that has been established by the
local medical society for hospitals in that
locale and established in a manner approved
by CMS
513
UR 2015
 There were no changes to this regulation,
 But corrected a guidance to reflect statutory
changes to SSA Section 1865
 Based on these statutory changes, any AO seeking
CMS approval of its hospital accreditation program
must demonstrate that it has standards for UR and
that its standards meet or exceed the Medicare
standards.
 Thus, we are removing language indicating that UR CoP
compliance must always be assessed by State Survey
Agencies since this is no longer the case for deemed
status hospitals.
514
UR Committee 654
 A committee may not be conducted by an
individual who has a direct financial or
ownership interest (5% or more)
 Who was professionally involved in the care
of the patient whose case is being reviewed
 Surveyor will look to see if the governing
board has delegated UR function to a outside
group if impracticable to have a staff
committee
515
Frequency of Review 655
 UR plan must provide review for
Medicare/Medicaid (M/M) patients with
respect to medical necessity
 Admissions (before, at, or after admission)
 Duration of stay
 Professional services furnished including
drugs and biologicals
516
Scope of Reviews 655
 Reviews may be on a sample basis except
for reviews of cases assumed to outlier
cases because of extended stay cases or
high costs
 Surveyor will examine UR plan to determine
if medical necessity is reviewed for
admission, duration of stay and services
provided
 If IPPS hospital there should be a review of the
duration of stay in cases assumed to be outlier
517
Admissions or Continued Stay
 Determination that admission or continued
stay is not medically necessary is made by
one member of UR committee if MD concurs
with determination of fails to present their
views when afforded the opportunity
 Must be made by two members in all other
cases (656)
 Remember 2 midnight rule and importance of
order and documentation
 Physician certification
518
519
Admissions or Continued Stay
 Before determination not medically
necessary, UR committee must consult the
MD responsible for the care and afford
opportunity to present their views
 Then committee must provide written
notification no later than two days after
determination to the hospital, patient and
practitioner responsible for care
520
Admissions or Continued Stay
 If attending doctor does not respond or contest
the findings of the committee, the findings are
final
 If physician of UR committee finds not medically
necessary no referral of committee is necessary
and he may notify the attending doctor
 If non-physician makes the determination it must
go to the committee
 A non-physician can not make this final
determination
521
Physical Environment 700
Hospital must be constructed, arranged,
and maintained to ensure the safety of
patient
And to provide diagnosis and treatment
and for services appropriate for the
community
This CoP applies to all locations of the
hospital, all campuses, all satellites
522
Physical Environment
 Hospital’s maintenance and hospital departments
responsible for the buildings and equipment must
be incorporated into the QAPI program
 Must also be in compliance with the QAPI
requirements
 Survey of physical environment should be
conducted by one surveyor
 LIFE SAFETY CODE survey may be conducted by
specially trained surveyor
 LS code very important and being hit hard in the surveys
523
524
Buildings 701
 Condition of physical plant and overall
hospital environment must be developed and
maintained for the safety and well being of
patients
 Making sure that a routine and PM activities
are done, as manufacturer requires and by
state and federal law
 Conduct ongoing maintenance inspections
 Routine and PM and testing activities should be
incorporated into hospital QAPI plan
525
Buildings Emergency Preparedness 701
 Includes developing and implementing
emergency preparedness plans and capabilities
 Must coordinate with federal, state, and local
emergency preparedness and health
authority (dept of health)
 To identify risks for their area (natural disasters,
bio-terrorism threats, disruption of utilities like
water, sewer, electrical, communication, fuel,
nuclear accident)
 Lists 14 things to consider in developing this
526
Proposed Changes to Emergency Preparedness
527
Emergency Preparedness Resources
There are many other organizations that
have resources on emergency
preparedness:
The Joint Commission
National Incident Management System
(NIMS)
Hospital Incident Command Systems
(HICS)
528
Emergency Preparedness Checklist Updated
529
Emergency Preparedness
 Transfer of hospital equipment to another facility
 Transfer or discharge of patients to home or other
hospitals
 Security of patients and walk in patients and
supplies from misappropriation
 Pharmacy, food, and other supplies and
equipment that may be needed
 Communication among staff
 Training needed to implement emergency
procedure
530
Emergency Gas and Water
 Must be facilities for emergency gas and water
supply (703)
 To provide care to inpatients
 Includes making arrangements with local utility
company for emergency sources of gas/water
 One source of water is Federal Emergency
Management Agency (FEMA)
 Gas includes propane, natural gas, fuel oil, as well
as gases used such as oxygen, nitrous oxide,
nitrogen
531
Trash 713
 Proper storage and disposal of trash
 Trash includes bio-hazardous waste
 Storage of trash must be in accordance with
state and federal law (EPA, CDC, OSHA,
state environmental health and safety
regulations)
 Need policies for storage and disposal of
trash
 H2E program - no fee (waste reduction, mercury, et
al.)1
www.h2e-online.org
1
532
Fire Control Plan 715
 Need fire control plan
 Must contain section on prompt reporting of
fires, extinguishing fires, protection of
patients and guests, evacuation and
cooperation with fire fighting authorities
 Surveyor will review fire plan
 Verify all fires are reported to state officials
 Will interview staff to make sure they know what to
do during a fire
 Amended for alcohol based hand dispensers
533
Facilities 722
 Keep written evidence of regular inspections and
approval by state or local fire control agencies
 Maintain adequate facilities for its service designed and maintained in accordance with
federal, state, and local laws
 Toilets, sinks, and equipment should be
accessible
 Make sure water acceptable for its intended
use such as drinking, lab water, irrigation
 Review water quality monitoring
534
Facilities 724
 Standard: Facilities, supplies, and equipment
must be maintained to ensure an acceptable
level of quality and safety
 Must make sure condition of hospital is maintained
in a manner to provide for acceptable level of safety
for patients, visitors, and staff
 Need supplies to meet patient needs
 Ensure against theft of contamination of supplies
 Need emergency supplies such as when a disaster
occurs
535
536
Facilities 724
 Need equipment when needed for patient care,
emergency use, or if there is a disaster
 Includes elevators, generators, air compressors, medical
equipment, vacuum, etc.
 Equipment inspected and tested before use
 Maintain records of who is competent to do
preventive maintenance
 Need equipment maintenance policies and
inventories of equipment
 Follow manufacturers recommendations and see
alternative equipment management program (AEM)
537
Ventilation, Light, Temperature
 There must be proper ventilation, light, and
temperature controls in pharmacy, food
preparation and other appropriate areas
 Proper ventilation in areas using ethylene
oxide, nitrous oxide, xylene, pentamidine,
glutaraldehyde, or other hazardous
substances
 Temperature controls in pharmacy and food
preparation
538
Ventilation, Light, Temperature
 Ventilation where O2 is transferred from one
container to another
 In isolation rooms and lab locations
 Adequate lighting in patient rooms and food
and medication preparation areas (shown to
reduce medication errors)
 Anesthetizing locations where nonflammable
inhalation anesthetic agents are used
 Will review temp monitoring records
539
Ventilation, Light, Temperature 726
 Temperature, humidity, and airflow in OR
within acceptable standards to inhibit
microbial growth
 Remember 2013 humidity memo & 2014 changes with
humidity 20-60% and when waiver is needed if not 35%
 Each OR room should have a separate temperature
control - have temp and humidity tracking logs
 Incorporate AORN – American Association of
Perioperative Registered Nurses should be
incorporated into hospital policy along with Facilities
Guidelines Institute (FGI)
540
541
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
542
Humidity in Anesthetizing Areas
543
Impact of Lowering the Humidity
 Lowering humidity can impact some equipment and
supplies
 Can affect shelf life and product integrity of some
sterile supplies including EKG electrodes
 Some electro-medical equipment may be affected by
electrostatic discharge especially older equipment
 Can cause erratic behavior of software and premature
failure of the equipment
 It can affect calibration of the equipment
 Follow the manufacturers instructions for use that
explains any RH requirements
544
CMS Memo on Low Relative Humidity
545
Impact of Lowering the Humidity
546
Lowering Humidity Can Have Other Effects
547
Infection Control 747
 Updated to reflect changing infectious and
communicable disease threats
 Including current knowledge and best practices
 Very important in today’s healthcare environment
 CDC estimates there are 1.7 million HAI in
hospitals every year and 99,000 deaths
 CMS gets $50 million dollar grant to enforce
 Interpretive guidelines are 12 pages long
1www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp
548
Safe Injection Practices Brief
www.empsf.org
549
Insulin Pens
www.cms.gov/Medicare/Provider-EnrollmentandCertification/SurveyCertificationGenInfo/Polic
y-and-Memos-to-States-and-Regions.html
550
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
 CDC issues reminder on same and has free flier
551
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/insulinpens.html
552
CDC Has Flier for Hospitals on Insulin Pens
553
Insulin Pen Posters and Brochures Available
www.oneandonlycampaign.org
/content/insulin-pen-safety
554
555
Brochure
556
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.
557
Single Dose June 15, 2012
558
CMS Memo on Safe Injection Practices
 Bottom line is you can not use a single dose vial on
multiple patients
 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
559
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/Practice
Tools/SterileProductsTool.aspx
 Click on starting using sterile products outsourcing tool
now
560
Infection Control
 TJC has chapter on Infection Prevention and
Control
 APIC and CMS now calls infection preventionists
(IPs)
 Hospital must have sanitary environment to
avoid sources and transmission of infection
and communicable diseases (750)
 Active IC program for prevention, control,
and investigation of infections and
communicable diseases
561
Remember the Final Infection Control Worksheet
562
Infection Control (IC)
 Standards apply to all departments of
hospitals both on and off campus
 Infection prevention must include monitoring
of housekeeping and maintenance including
construction activities
 Areas to monitor include food storage preparation,
serving and dish rooms, refrigerators, ice machines,
air handlers, autoclave rooms, venting systems,
inpatient rooms, supply storage and equipment
cleaning
563
Infection Control (IC) 747
 Must all standards of care and practice (APIC
(Association for Professionals in Infection Control
and Epidemiology), CDC, SHEA (Society for
Healthcare Epidemiology of America), OSHA, etc.
 Need to investigate infections and communicable
diseases for inpatients and from personnel working
in hospitals including volunteers
 Must have active surveillance program that includes
specific measures for infection detection, data
collection, analysis monitoring, and evaluations of
preventive interventions
564
Infection Control
 Must have sampling or other mechanism in place
to identify and monitor infections and
communicable diseases
 Infection control must be integrated in PI
 Surveillance activities should be conducted in
accordance with recognized surveillance practices
such as those used by CDC NHSN (National
Healthcare Safety Net)
 Requirement for hospitals to report central line infections
to NHSN
565
IC Officer’s Responsibilities
Many have added these to their job
descriptions
 Maintain sanitary hospital environment
(ventilation and water controls, construction make sure safe environment, safe air handling
in areas of special ventilations such as the OR
and isolation rooms, techniques for food
sanitation, cleaning and disinfecting surfaces,
carpeting and furniture, how is pest control
done, and disposal of trash along with nonregulated waste)
566
IC Officer’s Responsibilities
 Develop and implement IC measures
(hospital staff, contract workers, volunteers)
 Mitigation of risks associated with patient
infections present upon admission and risks
contributing to HAI
 Active surveillance
 Hospital must identify and track the following categories
 HAI selected by IC program targeted strategies based on
national guidelines and periodic risk assessments
 Patients or staff with reportable communicable diseases
567
IC Officer’s Responsibilities
 Active surveillance (continued)
 Culture or patient colonized with MDRO
 Isolation patients
 Staff or patients with signs in which local, state, or
feds request
 Staff or patients infected with significant pathogens
 Recommend use of automated surveillance
technology (blue box advisory) or data mining
 Monitoring compliance with all P&Ps, protocols and
other infection control program requirements
568
Blue Box Use Automated Surveillance
569
IC Officer’s Responsibilities
 Program evaluation and revision of the program,
when indicated
 Coordination as required by law with federal, state,
and local emergency preparedness and health
authorities to address communicable disease
threats, bioterrorism and outbreaks
 Complying with the reportable disease
requirements of the local health authority
 Make sure IC program is integrated into hospital
wide QAPI (now stands for quality assessment and
performance improvement)
570
Infection Control (IC) 749
 Long list of IC policies that hospitals must
have
 Maintain a sanitary physical environment
 Hospital staff related measures (evaluate
hospital staff immunization status for
infectious diseases as per CDC and APIC,
how you screen hospital staff for infections
likely to cause significant infectious disease
to others, policy on when staff are restricted
from working)
571
IC Policies to Include:
 New employees and what they need in orientation
(including handwashing)
 P&P to mitigate risk when patient admitted with
infection - must be consistent with the CDC isolation
guidelines, staff knowledge of PPE
 Mitigate risk that cause or contribute to HAI such as
SCIP measures, appropriate hair removal, timely
antibiotics in OR, DC in 24 hours except 48 hours for
cardiac patients, beta blockers during perioperative
periods for select cardiac patients, proper sterilization
of equipment, etc.
572
Immediate Use Steam Sterilization IUSS
573
Medical Equipment and Supplies Resources
 Multi-Society Guidelines for Reprocessing
Flexible Gastrointestinal Endoscopes by APIC at
www.apic.org/AM/Template.cfm?Section=Guidelines_and_Standards&template=/CM/ContentDis
play.cfm&section=Topics1&ContentID=6381
 Disinfection of Healthcare Equipment Chapter in
Guidelines for Disinfection and Sterilization in
Healthcare Facilities Nov 2008 at
www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf
 Single Use Device Reprocessing at http://cms.h2eonline.org/ee/waste-reduction/waste-minimization/
574
IC Policies
 Isolation procedures for highly immuno-suppressed
patients (HIV or chemo patients)
 Isolation procedures for trach care, respiratory care,
burns, and other similar situations
 Other HAI risk mitigation includes promotion of hand
hygiene, and measures to prevent organisms that are
antibiotic resistant such as MRSA and VRE
 Things such as central line bundle, VAP bundle or
sepsis bundle, prompt removal of foley catheter
 Disinfectants, antiseptics, and germicides must be used
in accordance with manufacturers instructions
575
IC Policies
 Appropriate use of facility and medical equipment
(hepa filters and negative pressure room, UV lights
and other equipment to prevent the spread of
infectious agents
 Patients, visitors, care givers, and staff must
receive education on infection and communicable
diseases
 There must be active surveillance system, method
for getting data to determine if there is a problem
 Policy on getting cultures from patients, etc.
576
Policies and Organization
 Need IC officer and IC committee
 IC officer must develop and implement
policies on control of infection and
communicable diseases
 Person must be designated in writing who is
qualified through education and experience
 Lists the responsibilities of this person consider putting into job description
577
CEO, CNO, and MS 756
 The CEO, DON, and MS must ensure that
there is hospital wide QAPI and training
program that address problems identified by
IC officer
 And implement a successful corrective action
plan in affected problem areas
 Train staff in problems identified
 Problems must be reported to nursing, MS,
and administration
578
Discharge Planning
 CMS issues 39 page memo effective July 2013
 Revises discharge planning standards
 Includes advisory practices (blue boxes) to promote
better patient outcomes
 Only suggestions and will not cite hospitals
 The discharge planning CoPs have been
reorganized
 A number of tags were eliminated
 The prior 24 standards have been consolidated into 13
579
CMS Discharge Planning Worksheet
580
Discharge Planning
 The hospital must have a discharge planning (DP)
process that applies to all patients (799)
 To determine if will need post hospital services like home
health, LTC, assisted living, hospice etc.
 To determine what patient will need for safe transition to
home
 Need to incorporate new research on care transitions
 Hospital needs adequate resources to prevent readmissions
 1 in 5 patients readmitted within 30 days (20%)
 1 in 3 patients readmitted within 60 days (34%)
 The hospital must have written DP P&Ps (799)
581
Discharge Planning (DP)
 CMS later says DP applies to inpatients only
 However, recommends an abbreviated DP for certain
categories of outpatients such as observation, ED, and
same day surgery
 DP based on 4 stage DP process
 Screen all patients to determine if patient at risk such as
screening questions by nursing admission assessment
 Evaluate post-discharge needs of patients
 Develop DP if indicated by the evaluation or requested by
patient or physician
 Initiate discharge plan prior to discharge of inpatient
582
Discharge Planning
 Suggest input from MS, board, HH, LTC and others
regarding the DP P&Ps
 Involve patient in the development of the plan of
care (799)
 Standard: The hospital must identify at an early
stage those patients who are likely to suffer adverse
consequences if no DP is done (800)
 Recommend all inpatients have a DP
 If not must document criteria and screening process used
to identify who is likely to need DP
 No national tool to do this
583
Discharge Planning
 Must do at least 48 hours in advance of discharge
 If patient’s stay is less than 48 hours then must make sure
DP is done before patient’s discharge
 Must make sure no evidence that patient’s
discharge was delayed due to hospital’s failure to
do DP (800)
 DP P&Ps must state how staff will become aware of
any changes in the patient’s condition (800)
 If patient is transferred must still include information
on post hospital needs (800)
584
Discharge Planning
 CMS instructs the surveyors to conduct discharge
tracers on open and closed inpatient records
 Standard: The hospital must provide a DP evaluation
to patients at risk, or requested by the patient or
doctor (806)
 Must include the likelihood of needing post hospital services like
home health, hospice, RT, rehab, nutritional consult, dialysis,
supplies, meals on wheels, transport, housekeeping, or LTC
 Is the patient going to need any special equipment (walker, BS
commode, etc.) or modifications to the home
 Must include an assessment if the patient can do self
care or others can do the care
585
Discharge Planning
 Must evaluate if patient can return to their home
 If from a LTC, hospice, assisted living then is the
patient able to return (806)
 Hospitals are expected to have knowledge of
capabilities of the LTC and Medicaid homes and
services provided (806)
 May need to coordinate with insurers and Medicaid
 Discuss ability to pay out of pocket expenses
 Expected to have know about community resources
 Such as Aging and Disability Resources or Center for Independent
Living
586
CMS DP Checklist for Patients
587
Discharge Planning
 Standard: A RN, SW, or other appropriately
qualified person must develop or supervise the
development of the DP evaluation (807)
 Written P&P must say who is qualified
 Standard: the DP evaluation must be completed
timely to avoid unnecessary delays (810)
 Standard: The hospital must discuss the results of
the DP evaluation with the patient (811)
 Standard: The DP evaluation must be in the
medical record (812)
588
Discharge Planning
 Standard” RN, SW, or other qualified person
must develop the discharge plan if the DP
evaluation indicates it is needed (818)
 DP is part of the plan of care
 Standard: The physician may request a DP if
hospital does not determine it is needed (819)
 Standard: The hospital must implement the DP plan
(820)
 Standard: The hospital must reassess the discharge
plan if factors affect the plan (821)
589
Discharge Planning
 Standard: If patient needs HH or LTC must provide
patients a list (823)
 Standard: Hospital must transfer or refer patients to
the appropriate facility or agency for follow up care
(837)
 Standard: the hospital must reassess it DP process
on an on-going basis and review the discharge
plans to ensure they meet the patient’s needs (843)
 Must track readmissions
 Must review P&P to make sure DP is ongoing on at least
a quarterly basis
590
Organ, Tissue, and Eye 884
 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
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)
 TJC has similar standards in TS or transplant safety chapter
591
OPO Agreements with Hospitals
 CMS has a section in the hospital CoP on OPO or
the organ procurement organizations
 Hospitals must have a written agreement with the
OPO
 Must do the one call rule and notify the OPO if
patient dies or death is imminent
 OPOs are not required to have an agreement with
a hospital that does not have an OR or a ventilator
 OPO have to contract with hospitals that request it
but limited to notification if no ventilator or OR
592
OPO Agreements with Hospitals
593
Organ, Tissue, and Eye
 Board must approve your organ
procurement policy
 Must integrate into hospital’s PI 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
594
Tissue and Eye Bank
 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
595
Family Notification
 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
 Have to work cooperatively with the OPO
and in educating staff
 OPO can review death records
596
Organ Donation
 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
 Surveyor will review complaint file for relevant
complaints
597
Organ Donation Training
 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
598
Organ Donation
 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
 Ensure patient is declared dead within acceptable
timeframe
599
Surgical Services 940
 If provide surgical services, service must be well
organized
 If outpatient surgery, must be consistent in quality
with inpatient care
 Must follow acceptable standards of practice, AMA,
ACOS, APIC, AORN
 Must be integrated into hospital wide QAPI
 Will inspect all OR rooms
 Access to OR and PACU must be limited to
authorized personnel
600
Surgical Services 940
 Conform to aseptic and sterile technique
 Appropriate cleaning between cases
 Room is suitable for kind of surgery performed
 Equipment available for rapid and routine
sterilization
 And it is monitored, inspected and maintained by
biomed program
 Temperature and humidity controlled and 2 CMS memos
 ACS and AORN have P&P on many of these
601
Surgery 942
 OR must be supervised by experienced RN or
MD/DO
 Must have specialized training in surgery and
management of surgical service operation
 Will review job description
 LPN’s and OR techs can serve as scrub nurses
under supervision of RN
 Qualified RN may perform circulating duties in OR LPN or surg tech may assist in circulating duties - if
allowed by state law
602
Surgical Privileges
 Surgical privileges must be delineated for all
practitioners performing surgery, in
accordance with competence of each
practitioner
 Surgery service must maintain roster
specifying the surgical privilege
 Privileges must be reviewed every two years
 Current list of surgeons suspended must
also be retained
 Discussed in the earlier sections
603
Surgical Privileges
 MS bylaws must have criteria for determining
privileges
 Surgical privileges are granted in accordance
with the competence of each
 MS appraisal procedure must evaluate each
practitioner’s training, education, experience,
and demonstrated competence
 As established by the QAPI program,
credentialing, adherence to hospital P&P, and
laws
604
Surgical Privileges 945
 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
605
Surgery Policies 951
 Aseptic and sterile surveillance and practice,
including scrub technique
 Identify infected and non-infected cases
 Housekeeping requirements/procedures
 Patient care requirements
 pre-op work area
 patient consents and releases
 safety practices
 patient identification process and clinical procedures
606
Surgery Policies 951
 Duties of scrub and circulating nurses
 Safety practices
 Surgical counts
 Scheduling of patients for surgery
 Personnel policies in OR
 Resuscitative techniques
 DNR status
 Care of surgical specimens
607
Surgery Policies A-0951
 Malignant hyperthermia
 Protocols for all surgical procedures
 Sterilization and disinfection procedures
 Acceptable OR attire
 Handling infectious and biomedical
waste
 Outpatient surgery post op planning
608
Preventing OR Fires 951
Read detailed section on use of alcohol
based skin prep and how to prevent an OR
fire
 AORN has very detailed policy on flammable prep
in the OR and how to prevent fires
 Special precautions developed by NFPA and
incorporated into NPSG by TJC
 ASA has good document on preventing fires in the
OR
 Pa Patient Safety Authority has great
recommendations
609
H&P 952
See prior sections on H&P
H&P must be on the chart before the
patient goes to surgery
Except in emergencies
P&P specify what is an emergency
610
Consent 955
 Informed consent is in three sections of the
CoPs and each is different and not a repeat
 Third section in the surgery chapter
 Surgical services
 Consent must be in chart before surgery
 Exception for emergencies
611
Informed Consent
 Recommend anesthesia consent now (955)
 Lists elements for well designed process,
which are the optional elements
 Mandatory elements were under MR section
 Specifies what must be in the consent policy
 Who can obtain
 Which procedures need consent
612
Informed Consent Policy
When is surgery an emergency
Content of consent form
Process to obtain consent
If consent obtained outside hospital
how to get it into medical records
Make sure it is on the chart before the
patient goes to surgery
613
Informed Consent 955
 Must disclose if residents, RNFA, Surgical PAs
Cardiovascular Techs are doing important tasks
 Important surgical tasks include: opening and
closing, dissecting tissue, removing tissue,
harvesting grafts, transplanting tissue,
administering anesthesia, implanting devices and
placing invasive lines
 But requirement to have this in writing in under
optional list or well designed list
614
Surgery Equipment 956
 Call-in system
 Cardiac monitor
 Defibrillator
 Aspirator (suction equipment)
 Trach set (cricothyroidotomy is not a
substitute)
 TJC PC.03.01.01 includes this plus
ventilator, and manual breathing bags
615
PACU 957
 Standard: Must be adequate provisions for
immediate post-op care
 Must be in accordance with acceptable
standards of care, for all patients including same
day surgery patients
 Such as following the ASPAN standards of
care and practice
 Separate room with limited access
 P&P specify transfer requirements to and from
PACU
616
617
PACU 957
 PACU assessment includes level of activity, level of
pain, respiration, BP, LOC, patient color, Aldrete
 If not sent to PACU then close observation of
patient until has gained consciousness by a
qualified RN
 Surveyor is instructed to observe care provided in
the PACU to make sure they are monitored and
assessed prior to transfer or discharge
 Will look to determine if hospital has system to
monitor needs of post-op patient transferred from
PACU to other areas of the hospital
618
Post-Operative Monitoring
 Hospitals are expected to have P&P on the
minimum scope and frequency of monitoring in
post-PACU setting
 Must be consistent with the standard of care
 Concerned about post-op patients receiving opioids
 Concern about risk for over-sedation and
respiratory depression
 Once out of PACU not monitored as frequently
 Need appropriate assessment to prevent these
complications (See Tag 405)
619
ASPAN
www.aspan.org/Home.aspx
620
OR Register 958
 Patient’s name, id number
 Date of surgery
 Total time of surgery
 Name of surgeons, nursing personnel,
anesthesiologist, and assistants
 Type of anesthesia
 Operative findings, pre-op and post-op diagnosis
 Age of patient
 See TJC RC.02.01.03 which are now the same
621
Operative Report 959
Name and identity of patient
Date and time of surgery
Name of surgeons, assistants
Pre-op and post-op diagnosis
Name of procedure
Type of anesthesia
622
Operative Report 959
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
623
Anesthesia 1000
 Must be provided in well organized manner under qualified
doctor
 Optional service
 Must be integrated into hospital PI
 MS establish criteria for director’s qualifications
 Revised December 11, 2009, Feb 5, 2010, May 21, 2010
and February 14, 2011
 Will review job description of director - see elements
 Wherever anesthesia is done - radiology, OB, OR,
outpatient surgery areas
 State exemption process of MD supervision for CRNA
624
CMS Anesthesia Standards Changes
 Hospitals are expected to have P&P on when
medications that fall along the analgesia-anesthesia
continuum are considered anesthesia
 P&P must be based on nationally recognized guidelines
 Must specify the qualifications of practitioners who
can administer analgesia
 CMS further clarified pre-anesthesia and postanesthesia evaluations
 CMS added FAQs which are very helpful
 Hospitals should review these as many changes and clarifications
were made
625
Epidural or Spinal in OB
 The administration of a regional (epidural or spinal)
for the purpose of analgesia during labor and
delivery
 Is not considered anesthesia
 Therefore, it is not subject to the supervision
requirements for CRNA
 Unless subsequent administration of medication for
operative delivery like a C-section then the
anesthesia standards apply
 This section was removed even though this has
always been CMS’s position
626
Anesthesia 1000
 If hospital provides any degree of anesthesia service
must comply with all CoPs
 Anesthesia involves administration of medication to
produce a blunting or loss of;
 pain perception (analgesia)
 Voluntary and involuntary movements
 Memory and or consciousness
 Analgesia is use of medication to provide pain relief
thru blocking pain receptor in peripheral and or CNS
where patient does not lose consciousness
 It is a continuum
627
Monitored Anesthesia Care (MAC)
 Anesthesia care that includes monitoring of patient
by an anesthesia professional (like
anesthesiologist or CRNA)
 Include potential to convert to a general or regional
anesthetic
 Deep sedation/analgesia is included in a MAC
 Deep sedation where drug induced depression of
consciousness during which patient can not easily
be aroused but responds purposefully following
repeated or painful stimulus
628
Anesthesia Services
1000
 Services not subject to anesthesia administration
and supervision requirements
 Topical or local anesthesia ; application or
injection of drug to stop a painful sensation
 Minimal sedation; drug induced state in which
patient can respond to verbal commands such as
oral medication to decrease anxiety for MRI
 Moderate or conscious sedation; in which
patients respond purposely to verbal commands,
either alone or by light tactile stimulation
629
Anesthesia Services 1000
 Rescue capacity
 Sedation is a continuum and not always possible to
predict how patient will respond so need intervention by
one with expertise in airway management
 Must have procedures in place to rescue patients whose
sedation becomes deeper than initially intended
 Anesthesia services must be under one anesthesia
services under direction of qualified physician no
matter where performed
 Operating room, both inpatient and outpatient
 OB, radiology, clinics, ED, psychiatry, endoscopy etc.
630
Anesthesia Services 1000
 There is no bright line between anesthesia and
analgesia
 TJC has standards also on how to safely
perform moderate or procedural sedation and
anesthesia in the PC chapter
 Also references the need to follow nationally
standards of practice such as ASA (American
Society of Anesthesiologists), ACEP (American
College of Emergency Physicians) and ASGE
(American Society for GI Endoscopy), AGA etc.
631
Anesthesia Services 1000
 Hospitals need to determine if sedation done in the
ED or procedures rooms is anesthesia or analgesia
 This standard also sets forth the supervision
requirements for staff who administer anesthesia
 P&Ps need to establish minimum qualifications and
supervision requirements including moderate
sedation
 MS credentialing standards and the nursing standards
exist to make sure staff are qualified and competent
 Must have P&P to look at adverse events, medication
errors and other safety and quality indicators
632
Anesthesia Services and Policies 1002
 Anesthesia must be consistent with needs of
patients and resources
 P&P must include delineation of pre-anesthesia
and post-anesthesia responsibilities
 Policies include;
 Consent
 Infection Control measures
 Safety practices in all areas
 How hospital anesthesia service needs are met
633
Anesthesia Policies Required 1002
 Policies required (continued);
 Protocols for life support function such as cardiac
or respiratory emergencies
 Reporting requirements
 Documentation requirements
 Equipment requirements
 Monitoring, inspecting, testing and maintenance
of anesthesia equipment
 Pre and post anesthesia responsibilities
634
Pre-Anesthesia Assessment 1003
 Pre-anesthesia evaluation must be performed with
48 hours prior to the surgery
 Including inpatient and outpatient procedures
 For regional, general, and MAC
 Not required for moderate sedation but still need to
do pre sedation assessment
 Preanesthesia assessment must be done by some
one qualified person to administer anesthetic (nondelegable)
635
Organization and Staffing 1003
 Pre-anesthesia assessment done by someone who
can administer anesthesia such as;
 Qualified anesthesiologist or CRNA, Qualified doctor
other than anesthesiologist
 Anesthesiology assistant (AA) under the supervision of
anesthesiologist who is immediately available if needed
 Dentist, oral surgeon, or podiatrist who is qualified to
administer anesthesia under state law
 CRNA may not require supervision if state got an
exemption1

1 List of 16 state exemptions at www.cms.hhs.gov/CFCsAndCoPs/02_Spotlight.asp Iowa, Nebraska, Idaho, Minnesota,
New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, South Dakota, Wisconsin, Montana,
Colorado, and California.
636
Pre-anesthesia Evaluation 1003
 Can not delegate the pre-anesthesia assessment to
someone who is not qualified
 Must be done within 24hours
 Delivery of first dose of medication for inducing
anesthesia marks end of 48 hour time frame
 However, some of the elements in the evaluation
can be collected prior to the 48 hours time frame
but it can never be more than 30 days
 o if you saw a patient on Friday for Monday surgery would
need to show that on Monday there were no changes
637
Pre-Anesthetic Assessment 1003
 Must include;
 Review of medical history, including anesthesia,
drug, and allergy history (within 48 hours)
 Interview and exam the patient
– Within 48 hours and rest are updated in 48 hours but can be
collected within 30 days
 Notation of anesthesia risk (such as ASA level)
 Potential anesthesia problems identification
(including what could be complication or
contraindication like difficult airway, ongoing
infection, or limited intravascular access)
638
Pre-Anesthetic Assessment 1003
 Pre-anesthetic Assessment to include (continued);
 Additional data or information in
accordance with SOC
 Including information such as stress test or
additional consults
 Develop plan of care including type of
medication for induction, maintenance, and
post-operative care
 Of the risks and benefits of the anesthesia
639
ASA Physical Status Classification System
 ASA PS I – normal healthy patient
 ASA PS II – patient with mild systemic disease
 ASA PS III – patient with severe systemic disease
 ASA PS IV – patient with severe systemic disease
that is a constant threat to life
 ASA PS V – moribund patient who is not expected
to survive without the operation
 ASA PS VI – declared brain-dead patient whose
organs are being removed for donor purposes
640
Survey Procedure Pre-anesthesia Evaluation
 Surveyor to review sample of inpatient and
outpatient records who had anesthesia
 Make sure pre-anesthesia evaluation done and by
one qualified to deliver anesthesia
 Determine the pre-anesthesia evaluation had all the
required elements
 Make sure done within 48 hours before first does of
medication given for purposes of inducing
anesthesia for the surgery or procedure
 ASA and AANA has pre-anesthesia standards
641
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
642
643
644
Intra-operative Anesthesia Record 1004
Need policies related to the intra-operative
anesthesia
Need intra-operative anesthesia record for patients
who have general, regional, or MAC
Intra-operative Record must contain the following:
 Include name and hospital id number
 Name of practitioner who administer anesthesia
 Techniques used and patient position, including insertion
of any intravascular or airway devices
645
Intra-operative Anesthesia Record
 Intra-operative Record must contain the following
(continued):
 Name, dosage, route and time of drugs
 Name and amount of IV fluids
 Blood/blood products
 Oxygenation and ventilation parameters
 Time based documentation of continuous vital signs
 Complications, adverse reactions, problems during
anesthesia with symptom, VS, treatment rendered and
response to treatment
646
Post-anesthesia Evaluation 1005
 Post-anesthesia evaluation must be done by some
one who is qualified to give anesthesia
 Must be done no later than 48 hours after the
surgery or procedure requiring anesthesia services
 Must be completed as required by hospital policies
and procedures
 Must be completed as required by any state specific
laws
 P&Ps must be approved by the MS
 P&Ps must reflect current standards of care
647
Post Anesthesia Evaluation 1005
 Document in chart within 48 hours for patients
receiving anesthesia services (general, regional,
MAC)
 For inpatients and outpatients now
 So may have to call some outpatients if not seen
before they left the hospital
 Note different for CAH hospitals under their
manual
 Does not have to be done by the same person who
administered the anesthesia
648
Post Anesthesia Evaluation
 Has to be done only by anesthesia person
(CRNA, AA, anesthesiologist) or qualified
doctor
 48 hours starts at time patient moved into
PACU or designated recovery area (SICU etc.)
 Evaluation can not generally be done at point
of movement to the recovery area since
patient not recovered from anesthesia
 Patient must be sufficiently recovered so as to participate
in the evaluation e.g. answer questions, perform simple
tasks etc.
649
Post Anesthesia Evaluation
 For same day surgeries may be done after
discharge if allowed by P&P and state law
 If the patient is still intubated and in the ICU still
need to do within the 48 hours
 Would just document that the patient is unable to
participate
 If patient requires long acting anesthesia that
would last beyond the 48 hours would just
document this and note that full recovery from
regional anesthesia has not occurred
650
Post-Anesthesia Assessment 1005
 Respiratory function with respiratory rate, airway
patency and oxygen saturation
 CV function including pulse rate and BP
 Mental status,
 Temperature
 Pain
 Nausea and vomiting
 Post-operative hydration
651
Post-Anesthesia Survey Procedure
 Surveyor is review medical records for patients
having anesthesia and make sure post-anesthesia
evaluation is in the chart
 Surveyor to make sure done by practitioner who is
qualified to give anesthesia
 Surveyor to make sure all postanesthesia
evaluations are done within 48 hours
 Surveyor to make sure all the required elements are
documented for the postanesthesia evaluation
652
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 postanesthesia or
post procedural complications
 Postanesthesia visits
653
654
Six FAQs
 How can the same drugs be used in the OR for
anesthesia but in the ED for a sedative?
 What nationally recognized guidelines are available
for hospitals to use to develop their P&Ps?
 What is the appropriate training for a sedation
nurse?
 Why is there a particular mention in the interpretive
guidelines on ED sedation policies?
 Can hospital adopt a P&P that all anesthesia agents
in lower doses can be used for sedation (NO!)
655
Nuclear Medicine 1025 2015
Services must meet needs of patients
Optional service
Radioactive material must be prepared,
labeled, uses, transported, stored and
disposed of in accordance with
acceptable standards of practice
 Will not discuss but be sure to provide to
your director if you do nuclear medicine the
revised standards in 2015
656
Nuclear Medicine 2015 1026
 Need to follow standards of practice (1026)
 Must follow state or federal laws
 Must follow recommendations by national
professional organizations such as:
 ACR, Radiologic Society of North America, America, the
Society of Nuclear Medicine and Molecular Imaging, the
American Society of Nuclear Cardiology, and the
American Association of Physicists in Medicine
 Hospital can run or have a contracted service
 Same risks such as patient can develop cancer
657
Nuclear Medicine 2015 1026
 Use as low as reasonably achievable (ALARA)
 Must be integrated into QAPI program
 Lists indicators of potential quality and safety
problems
 Wrong radiopharmaceutical is used
 Lack of premedication or no IV access so procedure is
cancelled
 Need a qualified NM medical director (1027)
approved by the Medical Staff
 Had written scope to show what services are offered
658
Nuclear Medicine 2015
 Radioactive material must be prepared, labeled,
used, transported, stored, and disposed of in
accordance with acceptable standards of practice
(1035)
 Must have a policy addressing the use of
radioactive materials in the hospital
 Must have clear signage
 Must protect high risk patients; pregnant, children,
multiple NM studies
 Monitor staff monitoring devices such as dosimeters
659
Nuclear Medicine 2015
 If lab tests done in NM service must meet CLIA
(1038)
 Equipment and supplies must be appropriate (1044)
 Must be maintain for safe and efficient performance
 Must be in good operating condition
 Must have signed and dated reports of
interpretations, consultations, and procedures (1051)
 Must be signed by MS who interpreted it
 Must keep copies for 5 years
660
Nuclear Medicine 2015
Must keep records of the receipt and
distribution of radiopharmaceuticals
(1054)
Need order of person who licensure and
privileges allow to order or board and
MS allow to order (1055)
661
Nuclear Med
1036 2015
 Must be maintained in safe operating
condition
 Inspected, tested, and calibrated annually by qualified
person
 Sign and date reports of nuclear interpretation,
consults, and procedures
 Keep copies for five years of records
 Radiopharmaceuticals can be prepared on off
hours without radiologist or pharmacist present
 Need P&P and follow guidelines like Society of NM
and Molecular Imaging
662
SNMMI Website
www.snmmi.org/
663
664
NM Tech Scope of Practice
665
Nuclear Medicine Tests
•Normal hepatobiliary scan
(HIDA scan) used to detect
gallbladder disease
 Normal pulmonary
ventilation and perfusion
V/Q scan
666
Outpatient Services 1076
2015
 Standard: Outpatient services must meet the
needs of the patient
 Must be in accordance with standards of practice
such as ACR, AMA, ACS, etc.
 Optional service but must comply with all CoPs
 Both on and off campus
 Outpatient services must be integrated into
hospital QAPI
 Theme in rest of slides with being involved in PI,
qualified director, follow SOCs, and met needs of
patients
667
Outpatient Services 1077
Must be integrated with inpatient
services
Medical records, radiology, lab, anesthesia,
including pain management, diagnostic
tests
Hospital must coordinate the care of the
patient
Make sure pertinent information in medical
record
668
Outpatient Services 1079 2013
 Have appropriate professional and nonprofessional
personnel bases on scope and complexity of
outpatient services
 Define in writing the qualifications and
competencies necessary to direct the department
 Should include education, experience and training
 Will review P&P to determine person’s
responsibility
 No longer a requirement to be sure that one person
is overlooking all of ambulatory patients care and
treatment (July 16, 2012)
669
Outpatient Tag 1079 2013
 The outpatient services department must be
accountable one or more individuals responsible
for the outpatient area
 No longer says it has to be single person responsible
 With appropriate personnel at each location where
outpatient services are rendered
 Hospital has flexibility to determine how to organize
their outpatient department
 Define in writing the qualifications and
competencies of each of the outpatient directors
670
Outpatient Tag 1079 2014
 Survey Procedures 482.54(b)
 Ask the hospital how it has organized its
outpatient services and to identify the
individual(s) responsible for providing direction
for outpatient services
 Review the organization’s policies and
procedures to determine the person’s
responsibility
 Will review the position description of the
individuals responsible for outpatient services
671
Outpatient Orders 1080
2015
Orders can be made by practitioner who is;
 Responsible for the care of the patient
 Licensed in state where he or she provides care to the
patient
 Within state scope of practice
 Authorized by the MS, approved by the board, to order
outpatient services under written P&P
 Whether C&P by the hospital or not
 Verify is licensed in state and within scope (NP, PA)
 Consider checking license, OIG excluded list of individuals, verify order
is from practitioner etc.
672
OIG List of Excluded Individuals
http://oig.hhs.gov/exclusions/index.asp
673
Outpatient Services 1081
2015
 Standard: Outpatient Services must meet the needs
of the patients in accordance with standards of
practice
 Like AMA, ACR, ACS, etc.
 It is optional to have outpatient services but if
provides must follow CoPs
 Services, equipment, staff, and facilities must be
appropriate
 Orders for outpatients may be made by practitioner
responsible for the care of the patient
674
Emergency Services 1100
Hospital must meet needs of patients
Optional for Medicare
Must follow acceptable standards of
practice
Must be integrated into hospital wide
QAPI
Need qualified MS director
675
Emergency Services
 Services must be integrated with other dept in
hospital
 Surgery, lab, medical records, et al.
 Includes communications between
departments
 Immediate availability of services, equipment,
and resources of hospital
 Length of time to transport between
departments is appropriate
676
Emergency Services
 Other departments must provide emergency
patients the care within safe and appropriate
times
 If offer urgent care on premises or in provider
based clinics must follow these regulations
 Remember there is a separate COP on
EMTALA
 Will review policies, including triage policy
677
Emergency Services
 Must have appropriate equipment
 Periodic assessments of its needs
 Work with state and feds in emergency
preparedness
 Surveyor will interview staff to see if
knowledgeable about blood, IV fluid,
parenteral administration of electrolytes,
injuries to extremities, CNS and prevention
of infection
678
Rehab Services 1123 2015
 Standard: If provides rehab, PT, OT, speech
language pathology, audiology, must be staffed and
organized to ensure safety of patients
 These staff must be qualified as specified by MS
and state law
 Meet standards - American Physical Therapy
Association, American Speech and Hearing
Association, American Occupational Therapy
Association, American College of Physicians, AMA
 Read what must be in the plan of care
679
Rehab Services
 Must be integrated into hospital wide QAPI
 Must have proper equipment and personnel
 Scope of service should be defined in writing
 Review medical records to verify each person
documents
 Director must be knowledgeable and experience
and capable
 Will review job description
 Services must be furnished in accordance with
written plan of care
680
Rehab Services 1132 2015
 Must be given in accordance with order of
practitioner including outpatient orders
 No longer says physician only
 Orders must be incorporated in the medical record
 Orders by one authorized by the MS to order and by P&P
 Could be PA, CNS, NP as allowed per hospital P&P
 Document order (1133)
 Must be consistent with state scope of practice
 Plan of care must meet criteria such as based on
assessment, measurable short and long term goals,
updated as needed
681
Respiratory Services 1151
 Must meet needs of patients
 Acceptable standard of practice
 Appropriate equipment and number of
qualified personnel
 Scope of service should be defined in writing
 Director who is doctor with experience to
supervise service
 List of written policies you must have
682
Respiratory Policies
 Equipment assembly, operation, PM
 Safety practices including IC for sterile supplies,
biohaz waste, posting of signs and gas line id
 CPR
 Pulmonary function testing
 Procedures to follow in the advent of adverse
reactions to treatments or interventions
 Therapeutic percussion and vibration
 Bronchopulmonary drainage
683
Respiratory Policies
 Mechanical ventilation
 Aerosol, humidification, and therapeutic gas
administration
 Storage, access and control of medications
 ABG procedure for analyzing
 CMS working on changes to respiratory and rehab
section so stayed tuned
 Need order but can be from physician or LIP as
allowed by state (scope of practice) and hospital
and PA or NP credentialed by Medical Staff
684
Respiratory Services 1164 (Last CoP)
 If blood gases or other clinical lab tests are
performed in unit then the applicable lab standards
must be met
 Need order of practitioner (1163, 2015)
including outpatient orders
 One licensed and qualified and within scope of practice
 Such as NP, PA, CNS
 Will review medical records
 Will review to make sure all required policies and
procedures are written
685
 Statement of Deficiencies and Plan of
corrections
 Based on documentation of surveyor
worksheet or notes and form CMS-2567
686
The End! Questions???
 Sue Dill Calloway RN, Esq. CPHRM
CCMSCP
 AD, BA, BSN, MSN, JD
 President of Patient Safety and
Education Consulting
 Board Member
Emergency Medicine Patient Safety
Foundation
 614 791-1468 (Call with questions, no emails)
 [email protected]
687
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 AIA - www.aia.org
 Occupational Safety and Health Administration OSHA –
www.osha.gov
 National Institutes of Health NIH - www.nih.gov
 United States Dept of Agriculture USDA - www.usda.gov
 Emergency Nurses Association ENA - www.ena.org
688
Websites
 American College of Emergency Physicians ACEP www.acep.org
 Joint Commission Joint Commission www.JointCommission.org
 Centers for Medicare and Medicaid Services CMS www.cms.hhs.gov
 American Association for Respiratory Care AARC www.aarc.org
 American College of Surgeons ACS -www.facs.org
 American Nurses Association ANA - www.ana.org
 AHRQ is www.ahrq.gov
 American Hospital Association AHA - www.aha.org
689
Websites
 U.S. Pharmacopeia (USP) www.usp.org
 U.S. Food and Drug Administration MedWatch www.fda.gov/medwatch
 Institute for Healthcare Improvement - www.ihi.org
 AHRQ at www.ahrq.gov
 Drug Enforcement Administration –www.dea.gov (copy of
controlled substance act)
 US Pharmacopeia - www.usp.org, (USP 797 book for sale)
 National Patient Safety Foundation at the AMA -www.amaassn.org/med-sci/npsf/htm
 The Institute for Safe Medication Practices - www.ismp.org
690
Websites
 CMS Life Safety Code page http://new.cms.hhs.gov/CFCsAndCoPs/07_LSC.asp
 American College of Radiology- www.acr.org
 Federal Emergency Management Agency (FEMA)www.fema.gov
 Sentinel event alerts at www.jointcommission.org
 American Pharmaceutical Association www.aphanet.org
 American Society of Heath-System Pharmacists www.ashp.org
691
Websites
 Enhancing Patient Safety and Errors in Healthcare www.mederrors.com
 National Coordinating Council for Medication Error
Reporting and Prevention - www.nccmerp.org,
 FDA's Recalls, Market Withdrawals and Safety
Alerts Page: www.fda.gov/opacom/7alerts.html
 Association for Professionals in Infection Control and
Epidemiology (APIC) infection control guidelines at
www.apic.org
 Centers for Disease Control and Prevention - www.cdc.gov
 Occupational Health and Safety Administration (OSHA) at
www.osha.gov
692
Infection Control Websites
 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
693
The End! Questions???
 Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
 AD, BA, BSN, MSN, JD
 President of Patient Safety and
Education Consulting
 Board Member
Emergency Medicine Patient
Safety Foundation
 614 791-1468
 [email protected]
694