CMS2015HOSPITALCOP
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Transcript CMS2015HOSPITALCOP
CMS HOSPITAL CONDITIONS OF
PARTICIPATION (COPS) 2015
All Day Program
What PPS Hospitals Need to Know
Speaker
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 www.empsf.org
614 791-1468 (no email questions, phone)
[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
– Many changes Sept 26, 2014, July 11, 2014, and
Medication& Safe Opioid Use in June 6, 2014 and January
30, 2015 memo and in April 1, 2015 manual
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
5
CMS Survey and Certification Website
www.cms.gov/SurveyCertific
ationGenInfo/PMSR/list.asp#
TopOfPage
Click on Policy & Memos
6
7
Example of Survey Memo Glucose Monitoring
8
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 is 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
The rule explains the decision making process and
addresses comments sent
9
Board and Medical Staff Final IGs
10
IG for Final Rules OP, NM, Dietary etc.
11
Changes to Hospital Sections
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)
12
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
13
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
14
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
15
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]
16
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
17
Location of CMS Hospital CoP Manual
New website
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
18
Final Changes in April 1, 2015 Manual
www.cms.hhs.gov/manuals/d
ownloads/som107_Appendixt
oc.pdf
19
Transmittals
www.cms.gov/Transmittals/
20
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,
program
Reporting to internal PI
Complaint manual and reporting to AO
Deficiencies of hospitals,
OPO,
Equipment Maintenance
Medication and Safe Opioid Use
Three worksheets finalized, Glucose Monitoring
21
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
22
Luer Misconnections
23
PA Patient Safety Authority Article
24
June 2010 Pa
Patient Safety Authority
25
ISMP Tubing Misconnections
www.ismp.org
26
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/
27
New Standards Prevent Tubing Misconnections
New and unique international standards being
developed in 2014 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
28
www.premierinc.com/tubingmisconnections/
29
Managing Risk During the Transition
30
Misconnections & How to Prepare
31
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
32
Final 3 Worksheets QAPI
www.cms.gov/SurveyCertificationG
enInfo/PMSR/list.asp#TopOfPage
33
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
34
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]
35
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
36
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
37
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
38
www.ashpfoundation.org/MainMenuCategories/Practice
Tools/SterileProductsTool.aspx
39
Safe Injection Practices www.empsf.org
40
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
41
Infection Control Breaches
42
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:
Using the same needle for more than one
individual;
43
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
44
3 EBOLA Memos Issued
45
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
46
Access to Hospital Complaint Data
47
Updated Deficiency Data Reports
www.cms.gov/Medicare/Provider-Enrollment-andCertification/CertificationandComplianc/Hospitals.html
48
Can Count the Deficiencies by Tag Number
49
Lists by State and Names Hospitals
50
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
51
Complaint Manual Update
52
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
53
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
54
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
55
Location of CMS Hospital CoP Manual
All the manuals are at
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
56
57
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
2014)
Q-Determining Immediate Jeopardy
I-Life Safety Code Violations
All CMS forms are on their website
58
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
59
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
60
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
61
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!
62
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
63
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
64
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
65
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
66
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
67
New website for all manuals
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
68
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
69
Compliance with Laws
0023, 0022
Hospital must be licensed or approved for
meeting standards for licensure, as applicable
Personnel must be licensed or certified if required by
state (doctors, nurses, PT, PA, 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
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
70
Governing Body (Board) 43 2013 & 2014
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.)
71
Governing Body (Board) 43
2013
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
72
Governing Body (Board) 43 2013 2014
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
73
Medical Staff and Board 2014
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
74
Medical Staff and Board 2014
Board appoints individuals to the MS with the
advice and recommendation of the MS (0046)
Will review board minutes to make sure they are
involved in appointment of MS
Board must assure MS has bylaws and they
comply with the CoPs (0047)
Board must make sure they have approved the MS
bylaws and rules and regulations (0048) and any
changes
TJC MS.01.01.01 as to what goes into a bylaw or R/R
75
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
76
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
77
Medical Staff 2013
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
78
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.
79
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
80
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
81
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
82
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
83
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
84
CEO
A-0057
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
85
Care of Patients 0063-0068
Board must make sure every patient has to be under
the care of a doctor (or dentist, podiatrist,
chiropractor, psychologist, et. al.)
Practitioners must be licensed and a member of MS
If LIPs can admit (NP, Midwives) still need to see
evidence of being under care of MD/DO
If state law allows needs policies and bylaws to
ensure compliance
Exception is a separate federal law where no
supervision required by midwives for Medicaid
patients
86
Care of Patients 0063-0068
Evidence of being under care of MD/DO must be in
the medical record
Verify with your state department of health what
documentation is required 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
87
Care of Patients 0067-68
Patient admitted by dentist, chiropractor,
podiatrist etc., needs to be monitored by a
MD/DO, as allowed by state law
Each state has a scope of practice which talks
about what they can do
The board and MS must have policies to make sure
Medicare/Medicaid patient is responsible for any
care OUTSIDE the scope of practice of the
admitting practitioner
What is the scope of practice in your state for NP,
CRNAs, Midwifes, and PAs?
88
Plan and Budget 0073-0077
Need institutional plan
Include annual operating budget with all
anticipated income and expenses
Provide for capital expenditures for 3 year 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
89
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
90
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
91
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
92
Emergency Services 0091
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
93
Emergency Services 0091
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
94
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
95
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
96
Number of Deficiencies July 2014
Section
Number Of
Deficiencies
Tag Number
Restraint and Seclusion 1,115
Tag 154-214
Care in a Safe Setting
578
Tag 144
Grievances
Consent & Decision
Making
Freedom from Abuse &
Neglect
417
247
Tag 118-123
Tag 131-132
232
Tag 145
Notice of Patient Rights 121
Tag 116 and 117
Care Planning
Tag 130
79
Number of Deficiencies July 2014
Section
Number of
Deficiencies
Tag Number
Privacy and Safety
100
142 and 143
Confidentiality
64
146 and 147
Visitation
23
215-217
Access to Medical Records
Protect Patient Rights
16
308
148
115
Admission Status Notification 12
133
Exercise of Patient Rights
129
Total 3,323
11
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
99
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
100
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
101
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
States can specify a state law for doing this
Hospital must adopt P&P on this
102
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
103
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
104
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
105
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
106
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
107
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
108
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
109
110
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
111
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
112
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
113
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
114
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
115
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
116
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
117
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
118
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?
119
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
120
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
121
www.cms.hhs.gov/bni
122
KEPRO and Livanta QIOs
www.qionews.org/articles/july-2014-special-focus/beneficiary-and-family-centered-care-qualityimprovement-orga
123
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
124
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
125
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
126
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
127
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
128
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
129
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
130
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
131
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
132
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
133
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
134
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
135
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)
136
Have a Policy to Hit All the Elements
137
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
138
Standard #2 Exercise of Rights 0130 12-11
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
139
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
140
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
141
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
142
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
143
Informed Consent 131
12-2-11
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
144
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
145
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
146
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
147
Disclosures to Patients 131 10-7-11 & 2013
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
148
Disclosures to Patients 131
2013
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
149
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
150
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
151
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
152
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
153
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
154
Privacy & Confidentiality Memo 3-2-12 Tag 143
155
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)
156
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
157
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
158
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
159
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
160
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
161
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
162
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
163
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
164
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
165
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.
166
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
167
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
168
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
169
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
170
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
171
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
172
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.
173
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
174
5th Standard Restraints 0154-0214
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
175
Restraint Patient Safety Brief
www.empsf.org
176
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
177
Reporting Deaths Unless 2 Soft Wrist Restraints
178
Type In Information and Print Off
www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10455.pdf
179
180
Restraint Form CMS-10455
181
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
182
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
183
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)
184
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)
185
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
186
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
187
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
188
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
189
190
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
191
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
192
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)
193
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
194
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)
195
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
Striker beds, narrow gurneys, or the narrow
carts and their use of side rails are not a
restraint
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
196
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
197
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
198
So, Is This a Restraint?
199
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
200
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
201
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
202
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
203
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)
204
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
205
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: ____________________________
206
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
207
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
208
Least Restrictive Restraint to More
209
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
210
Consider Alternatives
211
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
212
Alternatives to Restraints
Watching TV
Massage or family can hire massage
therapist
Punching bag
Avoid sensory overload
Fish tanks
Tapes of families or friends
213
214
215
216
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)
217
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
218
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)
219
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
220
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
221
222
Restraints - 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
223
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)
224
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
225
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
226
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
227
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
228
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
229
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)
230
Document Type of Restraint
231
Not a Good Documentation Sheet
232
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
233
234
235
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
236
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
237
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
238
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
239
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)
240
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
241
242
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
243
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
244
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
245
246
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)
247
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
248
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
249
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
250
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.
251
252
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)
253
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)
254
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
255
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
256
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
257
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
258
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
259
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
260
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
261
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
262
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
263
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
264
Rule #21 Deaths 0214
“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
265
Soft Wrist Restraints 2013
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
266
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
267
Visitation 215
Dec 2011
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
268
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.
269
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
270
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
271
Support Person
272
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
273
Report Adverse Events to PI
274
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
275
hwww.psoppc.org/web/patientsafety
276
Hospital Common Formats
277
2014 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
278
March 21, 2014 Manual Rewrites 7 Tags
279
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
280
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
281
CMS Hospital CoPs 2014
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
282
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
283
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
284
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
285
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
286
287
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
288
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
289
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?
290
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
291
Medical Staff 0338 2014
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
These have been discussed previously
Each hospital can have a separate medical
staff or a unified integrated (shared) medical
staff if requirements are meet
292
Medical Staff 2014
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
293
Medical Staff 2014
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
294
Medical Staff 0340
2013
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
295
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
296
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
297
Medical Staff 0341 and 342 2013
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
298
Medical Staff Organization 347 2014
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
299
Hospital Part of a System 348 2014
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
300
Hospital System 349 9-26-2014
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
301
Hospital System & Shared MS 350 9-26-2014
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
302
Hospital System & Shared MS 351 9-26-2014
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)
303
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)
304
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)
305
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
306
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
307
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
308
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
309
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
310
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
311
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
312
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
313
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
314
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
315
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
316
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
317
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
318
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)
319
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
320
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
321
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
322
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
323
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
324
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
325
Preparation/Admin of Drugs 405 2014
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
326
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
327
Changes to Tag 405 Medications 30 Minutes
328
Changes to 405 June 7, 2013
329
March 14, 2014 Memo Amends Tag 405
330
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
331
Pharmacy Should Prepare Piggybacks & IVs
332
Administration of Meds 0405
2014
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
333
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.
334
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
335
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
336
ISMP List of High Alert Medication
337
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
338
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
339
9 Rights of Medication Administration
340
Physician Order 406 2013
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
341
Physician Order 406 2013
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
342
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
343
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
344
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
345
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
346
Verbal Orders 2013
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
347
CMS Verbal Orders 2013
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
348
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
349
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
350
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
351
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)
352
Blood Transfusions and IVs 409 2013 & 2014
Standard: Blood transfusions and IV medications
must be administered with state law and MS P&P
CMS previously issued a memo on May 13, 2011
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
353
Blood and IV Medication Training 2014
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
354
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
355
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
356
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
357
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
358
359
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
360
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
361
Blood Transfusions and IVs 2013/2014
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
362
Incident Reports Transfusions
2013
There must be procedure for reporting
transfusion reactions, adverse drug reactions
and errors in administration of drugs (410)
Survey procedure - request procedure for reportingthey 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 which was updated May 20, 2011 on
this issue
363
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
364
Self Administration of Medication 412 2013
New tag number in 2013, Tag 412 and 413
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
365
Self Administration of Medication 412 2013
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
366
CMS Self Administered Drugs 412 and 413
367
See Tag 412 and 413 March 2013
368
Medical Record Services 0432
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
369
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
370
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
371
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
372
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
373
Privacy & Confidentiality Memo 3-2-12 Tag 147
374
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
375
Tag 441 Confidentiality of Medical Records
376
Tag 442 and 443 Deleted
377
Confidentiality 441 2013
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
378
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
379
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
380
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
381
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
382
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
383
CMS Signature Guidelines
April 16, 2010 CMS issues new signature guidelines and
says no rubber stamps
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
384
385
386
387
Verbal Orders 454 and 457 2013
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
388
Tag 457 Standing Orders 2013
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
389
Tag 457 Standing Orders 2013
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
390
Tag 457 Standing Orders 2013
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
391
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
392
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
393
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
394
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
395
Tag 457 Standing Orders 2013
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
396
History and Physical 458 and 461 2013
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
397
MR Must Contain 464 and 465 2013
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
398
Informed Consent 466
2013
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
399
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
400
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
401
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
402
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
403
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)
404
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
405
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
406
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
407
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
408
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
409
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
410
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
411
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
412
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
413
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
414
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
415
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
416
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)
417
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
418
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
419
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
420
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
421
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
422
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
423
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
424
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
425
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
426
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
427
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
428
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
429
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
430
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
431
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
432
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
433
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
434
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
435
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
436
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
437
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
438
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.
439
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
440
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
441
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
442
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.
443
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
444
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?
445
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
446
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
447
Radiology 529
Hospital has radiology services to meet
needs of patients
Radiology services should be provided in
accordance with accepted standards of
practice
Radiology, especially ionizing procedures,
must be free from hazards for patients and
personnel
Must have policy that provides for safety of both
448
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)
449
Personnel 545
Qualified radiologist must supervise ionizing
radiology services (546)
Must interpret those tests that are
determined by the MS to require a
radiologist’s specialized knowledge
Written policy approved by MS to designate
which tests require interpretation by
radiologist
If telemedicine is used, radiologist interpreting must
be licensed and meet state law requirements (state
medical board requirements), (546, see Tag 23)
450
Personnel 546
Supervision of radiology by radiologist who is
member of the MS, Supervision should include the
following
Ensure reports are signed by the practitioner
who interpreted them
Assign duties to personnel based on their level of
training, experience and licensure
Enforce infection control standards
Ensure emergency care if patient experience
ADR to diagnostic agent
451
Radiology 547
Ensure files, records are kept in secure area and
retrievable, train staff on how to operate
equipment safely
Written policy, approved by the MS on who can
use radiology equipment and administer
procedures
Only qualified personnel may use radiology
equipment
Surveyor will review personnel folders to make
sure they are qualified as established by the MS
for the tasks they perform
452
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
Must have written P&P that ensure the integrity of
authentication and protect privacy of radiology records - must
be secure and retrievable for five years (555)
Radiologist or other practitioner who performs radiology
services must sign the report of his or her interpretation
They have to be signed by the one who read and evaluated
the x-ray (not the partner who is reviewing the dictated report ),
A-0554
453
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
454
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
455
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
456
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
457
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
458
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)
459
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)
460
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
461
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
462
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
463
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
464
CMS Changes
CMS published some final changes to hospital CoP
effective July 11, 2014
Interpretive guidelines published January 30, 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
465
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
466
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
467
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.
468
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
469
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
470
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
471
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
472
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
473
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
474
CMS Rewrites Tag 629
475
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
476
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
477
IOM DRI or Dietary Reference Intake
http://fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes/dri-nutrient-reports
478
479
Dietary Guidelines for Americans
480
Watch for Changes in 2015
http://www.health.gov/dietaryguidelines/
481
482
Interactive DRI Tool and Tables
483
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
484
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
485
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.
486
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
487
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
488
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
489
Patient Diets New Tag 630 2015
490
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
491
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.
492
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
493
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
494
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
495
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
496
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.
497
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
498
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
499
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
500
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
501
502
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
503
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
504
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
505
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
506
507
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
508
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
509
Proposed Changes to Emergency Preparedness
510
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)
511
Emergency Preparedness Checklist Updated
512
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
513
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
514
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
515
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
516
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
517
Facilities 724 2-21-2014
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
518
519
Facilities 724 2-21-2014
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)
520
Ventilation, Light, Temperature 2014
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
Amended 1-31-2014
521
Ventilation, Light, Temperature 2014
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
522
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)
523
524
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
525
Humidity in Anesthetizing Areas
526
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
527
CMS Memo on Low Relative Humidity
528
Impact of Lowering the Humidity
529
Lowering Humidity Can Have Other Effects
530
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
531
Safe Injection Practices Brief
www.empsf.org
532
Insulin Pens
www.cms.gov/Medicare/Provider-EnrollmentandCertification/SurveyCertificationGenInfo/Polic
y-and-Memos-to-States-and-Regions.html
533
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
534
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/insulinpens.html
535
CDC Has Flier for Hospitals on Insulin Pens
536
VA Alert on Insulin Pens
Pharmacist found several insulin pens not labeled
for individual use
Found used multi-dose pen injectors used on
multiple patients instead of one patient use
New requirement that can only be stored in
pharmacy and never ward stocked
Instituted new education for staff on use
Part of annual competency of staff
Instituted new policy of safe use of pen injectors
537
VA Issues Alert in 2013
538
VA Alert on Insulin Pens
Decided to prohibit multi-dose insulin pen injectors
on all patient units except the following:
Patients being educated prior to discharge to use a
insulin pen injector
Eligible patient is self medication program
Patient needing treatment and no alternative
formulation is available
Patients participating in a research protocol requiring
an insulin pen
Pen injectors dispensed directly to patients as an
outpatient prescription
539
FDA Issues An Alert in 2009
540
Insulin Pen Posters and Brochures Available
www.oneandonlycampaign.org
/content/insulin-pen-safety
541
542
Brochure
543
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.
544
Single Dose June 15, 2012
545
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
546
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
547
www.ashpfoundation.org/MainMenuCategories/Practice
Tools/SterileProductsTool.aspx
548
Safe Injection Practices www.empsf.org
549
Infection Control 2013
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
550
Remember the Final Infection Control Worksheet
551
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
552
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
553
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
554
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)
555
IC Officer’s Responsibilities 2013
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
556
IC Officer’s Responsibilities 2013
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
557
Blue Box Use Automated Surveillance
558
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)
559
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)
560
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.
561
Immediate Use Steam Sterilization IUSS
562
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§ion=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/
563
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
564
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.
565
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
566
Log of Incidents 750
7-16-2012 Deleted
Must NO longer maintain a log related to infections
and communicable diseases, including HAI
Use to require a log and it had to include information
from patients and staff so need information from
employee health nurse
Included employees, contract staff such as agency
nurses, and volunteers
Included surgical site infections, patients or staff with
MDRO, patients who meet isolation requirements
Log use to be either a paper or electronic log, TJC
IC.01.01.01 requirement but will change to CMS
567
CEO, CNO, and MS 756
2013
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
568
Discharge Planning
CMS issues 39 page memo on May 17, 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
569
Discharge Planning Revisions
570
Transmittal July 19, 2013
571
2014 CMS Discharge Planning Worksheet
572
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)
573
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
574
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
575
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)
576
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
577
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
578
CMS DP Checklist for Patients
579
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)
580
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)
581
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
582
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
583
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
584
OPO Agreements with Hospitals
585
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
586
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
587
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
588
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
589
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
590
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
591
Organ Transplantation
Hospital in which organ transplants are
performed must be member of OPTN-Organ
Procurement and Transplantation Network
Must abide by its rules - 42 USC 274,
section 372 of the Public Health Service Act
Must provide data to OPTN, Scientific
Registry and OPO (Organ Procurement
Organization)
592
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
593
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
594
Humidity in Anesthetizing Areas
595
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
ACS and AORN have P&P on many of these
596
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
597
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
598
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
599
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
600
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
601
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
602
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
603
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
604
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
605
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
606
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
607
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
608
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
609
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
610
PACU 957
6-6-2014
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
611
2014 Changes to PACU Section
612
613
PACU 957
2014
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
614
Post-Operative Monitoring 2014
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)
615
ASPAN
www.aspan.org/Home.aspx
616
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
617
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
618
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
619
Anesthesia A-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
620
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
621
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
622
Anesthesia A-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
623
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
624
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
625
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.
626
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.
627
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
628
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
629
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
630
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)
631
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.
632
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
633
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)
634
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
635
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
636
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
637
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
638
639
640
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
641
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
642
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
643
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
644
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.
645
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
646
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
647
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
648
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
649
650
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!)
651
Nuclear Medicine 1026
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
652
Nuclear Medicine
Hospital must have written safety standards for
radioactive material
Handling of equipment and material
Protection of patients and staff from radiation
hazards
Labeling of materials and waste
Transportation of same
Security of radioactive material
Testing of equipment for radioactive hazards, et. al.
653
Equipment and Supplies
Must be appropriate for types of nuclear
med services offered
Must function in accordance with federal
and state laws governing radiation safety see 21 CFR Subpart J, Radiological Health
See 10 CFR. Chapter 1, Part 20, US
Nuclear Regulatory Commission Standards
for Protection against Ionizing Radiation
654
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
655
SNMMI Website
www.snmmi.org/
656
657
658
NM Tech Scope of Practice
659
Nuclear Med
Practitioner who interprets test must sign
and date the test and be approved by MS to
interpret
Must maintain records of the receipt and
distribution of radio pharmaceuticals
Nuclear med studies must be ordered by
practitioners who scope of federal or state
licensure allow such referrals and who has
staff privileges to perform
660
Nuclear Medicine Tests
•Normal hepatobiliary scan
(HIDA scan) used to detect
gallbladder disease
Normal pulmonary
ventilation and perfusion
V/Q scan
661
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
662
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
663
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)
664
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
665
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
666
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.
667
OIG List of Excluded Individuals
http://oig.hhs.gov/exclusions/index.asp
668
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
669
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
670
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
671
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
672
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
673
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
674
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
675
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
676
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
677
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
678
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
679
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
680
Statement of Deficiencies and Plan of
corrections
Based on documentation of surveyor
worksheet or notes and form CMS-2567
681
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]
682
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
683
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
684
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
685
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
686
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
687
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
688
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]
689