CMS HOSPITAL CONDITIONS OF
PARTICIPATION (COPS) 2011
What PPS Hospitals Need to Know
Speaker
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
President
Patient Safety and Healthcare
Education
5447 Fawnbrook Lane
Dublin, Ohio 43017
614791-1468
sdill1@columbus.rr.com
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The Conditions of Participation
 Regulations first published in 1966
 Many revisions since with final interpretive guidelines
June 5, 2009 (Tag 450 Medical Record) and anesthesia
(December 11, 2009, February 5, 2010, May 21, 2010
and February 14, 2011) and Respiratory and Rehab
Orders August 16, 2010 and Visitation 2011
 First regulations are published in the Federal
Register first-42 CFR Part 4821
 CMS then publishes Interpretive Guidelines2
 Hospitals should check this website once a month for
changes
1www.gpoaccess.gov/fr/index.html
2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp
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Respiratory and Rehab Orders
 Published in the August 16, 2010 Federal Register
 Allows a qualified licensed practitioner who is
responsible for the care of the patient (such as a
PA or NP)
 Who is acting within their scope of practice under
state law
 Can order respiratory or rehab order (physical
therapy, occupational therapy, speech)
 Must be privileged (authorized) by the MS
 Must have hospital P&P to allow also
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Visitation
 Effective January 19, 2011
 Must rewrite policy on visitation including visiting
hours in ICU
 Must inform each patient of their visitation rights
 Must include any restrictions on those rights
 Can not restrict or deny visitation privileges on the
basis of race, color, national origin, religion, sex,
sexual orientation, gender identity or disability
 For example same sex partner may present
visitation advance directive
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Federal Register Visitation Changes
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CMS Proposed New Rule
 CMS proposed new rule for notifying beneficiaries
of their right to file a quality of care complaint
 Give beneficiaries written notice of their right to contact
their state QIO or Quality Improvement Organization
 Also include
 Currently, only hospital inpatients receive this
information
 Includes 10 facilities such as clinics, CAH, LTC,
hospices, home health agencies, ASCs,
comprehensive outpatient rehab facilities, portable
X-ray services and rural health clinics
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Medicare Patients, Complaints and the QIO
 The proposed rule was published in the Federal
Register on February 2, 2011
 at http://www.gpo.gov/fdsys/pkg/FR-2011-02-02/pdf/20112275.pdf
 QIOs must conduct a review of all written complaints
about the quality of care for Medicare patients only
 Current hospital CoP includes a requirement that the
grievance process must include a mechanism for timely
referral to the QIO of beneficiary concerns regarding
quality of care
 Must also give Medicare patients a copy of their IM Notice
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Medicare Patients, Complaints and the QIO
 Since 9th scope of work started August 1, 2008,
QIOs have received 6,379 inpatient and 4,1116
outpatient requests
 Feel number is inadequate because Medicare
patients do not know they can complain to their QIO
 Expanding now that Medicare patients, or their
representative, will receive written notice at the
start of their care, of their right that they can
complain about quality of care issues to the QIO in
other settings
 Such as time of admission or in advance of furnishing
care
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Medicare Patients, Complaints and the QIO
 Medicare patient who is competent can also decide to have
the written notice given to their surrogate such as a friend or
family member
 Remember if need to use an interpreter for limited English
proficiency (LEP) or deaf/hard of hearing patients
 Unless patient signs a waiver declining interpreter
 Remember the 2011 TJC patient centered
communication standards
 Also 7 of the 10 providers must include information
to contact the state agency
 Hospitals, HH, RHC, CORF, FQHCs, Hospices, clinics
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Specific Requirements
 For example an ASC, hospice, hospitals, home
health, hospice etc. would have to do the following;
 Give the patient a written notice of their right to
notify the QIO
 Must include at the time of admission or in
advance of furnishing care
 Must include name, telephone number, email
address, and mailing address
 Must document in the medical record that the
notice was given
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Proposed FR February 2, 2011
14
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)
15
http://www.cms.hhs.gov/ma
nuals/downloads/som107_A
ppendicestoc.pdf
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4th Anesthesia Changes February 14, 2011
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Respiratory and Rehab Changes
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Mandatory Compliance
 Hospitals that participate in Medicare or Medicaid
must meet the COPs for all patients in the facilities
and not just those patients who are Medicare or
Medicaid
 Hospitals accredited by TJC, AOA, or DNV
Healthcare have what is called deemed status
 These are the only 3 that CMS has given deemed status
to for hospitals
 This means you can get reimbursed without going
through a state agency survey
 States can still institute a survey and be more restrictive
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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-1163 and 370 pages long
 You can look up any tag number under this manual
 Manuals
 Manuals are now being updated more frequently
 Still need to check survey and certification website
once a month and transmittals to keep up on new
changes
2
1http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
2 http://www.cms.gov/Transmittals/01_overview.asp
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http://www.cms.hhs.gov/manuals/downloads/som10
7_Appendicestoc.pdf
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Conditions of Participation (CoPs)
Important interpretive guidelines for hospitals and to
keep handy
 A- Hospitals and C-Critical Access Hospitals
 C-Labs
 V-EMTALA (Rewritten May 29, 2009 and
amended July 2010)
 Q-Determining Immediate Jeopardy
 I-Life Safety Code Violations
 All CMS forms are on their website
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Contact for Questions
 Resource is 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 there is always the name
and phone number of a contact person at
CMS
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Survey Procedure
 Step one is publication in Federal Register
 Step two is where CMS publishes the interpretive
guidelines
 The interpretive guidelines provide instructions to
the surveyors on how to survey the CoPs
 These are called survey procedure
 Not all the standards have survey procedures
 Questions such as “Ask patients to tell you if the
hospital told them about their rights”
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Interpretive Guidelines
 Surveyors use the information contained in
the interpretive guidelines
 They do not replace or supersede the law
Should not be used as basis for citation
 They do contain authoritative
interpretations and clarifications which can
assist surveyors in making determinations
of compliance
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Compliance Recommendation
 Assign each section of the hospital CoPs to the
manager of that department
 Do a side by side gap analysis like the TJC PPR
for each section
 Have standard on left side and go line by line and
document compliance on the right side
 Keep a hard copy of CoP and analysis
 Designate someone in charge if a validation,
complaint, or unannounced survey occurs
 Commonly referred to as the CoP king or queen
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CMS Required Education
 These will be discussed throughout presentation:
 Restraint and seclusion (annual)
 Abuse, neglect and harassment (annual)
 Infection control
 Advance directive
 Organ donation
 IVs and blood and blood products
 ED common emergencies, IVs and blood and blood
products for ED
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What’s Really Important
 Life Safety Code Compliance
 Infection Control and CMS gets $50 million grant to
enforce in 2011
 Patient Rights especially R&S and grievances
 EMTALA
 Performance Improvement (CMS calls it QAPI)
 Medication Management
 Dietary and cleanliness of dietary
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What’s Really Important
 Verbal orders
 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 within 30 minute time frame
 Outpatient under one person (Tag 1078)
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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
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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 separate
manual
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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
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Task 1 – Off Site Survey Prep
 Team coordinator gathers information about
provider (ownership, types of services offered,
locations)
 Determines if provider based, remote locations,
PPS-exempt services offered
 Information collected from CMS database such
as previous surveys and findings, size of
facility, and average daily census
 Team should enter together and usually goes
to administration
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Task 2 – Entrance Activities
 Team will explains purpose and scope of survey
 ENTRANCE CONFERENCE – sets the tone for
entire survey
 Give surveyors conference room, telephone
 Give names of department heads, their location
and phone numbers
 CMS has a list of documents they may ask for so
be ready and know what is on this list
 Provide organizational chart
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Task 2 – Entrance Activities
 Provide additional information
 Infection control plan
 Names and addresses of all off-site locations and provider
numbers
 List of employees
 Medical staff bylaws, rules and regulations
 List of contracted services
 Copy of floor plan
 List of current patients with room numbers, doctors
 Give preliminary date and time for exit conference
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Task 3 – Information Gathering
 Purpose is to determine compliance with CoPs thru
observation, interviews, and document review
 Will visit patient care areas including ED and
outpatient, Imaging, rehab, and remote locations
 Observe actual care (IV, tube feeding, wound
dressing changes)
 May observe a nurse pass medications
 Review copies of materials
 Use interpretive guidelines to guide survey
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Task 3 – Information Gathering
 Use Appendix Q if Immediate Jeopardy is
suspected
 Surveyor has discretion whether to allow staff to
accompany the surveyor
 All significant adverse events should be brought to
the team coordinator’s attention immediately
 Surveyors must respect patient privacy and
confidentiality
 Work with surveyor so they do not take peer-review
protected documents with them
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Task 4 Analysis of Finding
 If surveyor makes copies of documents ask to
make one for the hospital
 No federal review law but if in PSO surveyor can not see
 Review and analyze all information gathered
 Determine if CoPs are met and if PPS exclusionary
criteria (42 CFR Part 412, subpart B) or swing bed
(42 CFR 482.66)
 Prepare exit conference report
 If noncompliance with CoP then determine if at
standard or condition level and how dangerous it is
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Deficiency
 Condition level - (NOT GOOD) due to
noncompliance with requirement in a single
standard or several standards within the condition or
single tag but represents a severe or critical health
breach, (need to have conversation)
 Standard level - noncompliance as above but not
of such a character to limit facility’s capacity to
furnish adequate care - no jeopardy or adverse
effect to health or safety of patient
 Try and work with the surveyor to resolve the issue
before CMS leaves the building
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Task 5 Exit Conference
 Objective - inform facility of preliminary findings
 Policy is to do exit conference
 Can refuse if hostile environment or
 Counsel tries to turn into evidentiary hearing
 If recorded, must provide two tapes and tape
recorders
 Tape at same time and give surveyor one
 Official findings are provided in writing on Form
CMS 2567 (all forms on CMS website now)
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Task 5 Exit Conference
 Surveyor can set ground rules
 Present findings of noncompliance
 Statement of deficiencies will be mailed and have
10 working days to fix (Form 2567)
 This form is made public no later than 90 days
after survey
 So try and fix before the surveyor leaves
 List deficiencies, plans for correction, timelines
and opportunity to refute findings
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Task 6 Post-Survey Activities
 Objective is to complete the survey and
certification requirements and notify staff regarding
survey results
 Complete hospital restraint/seclusion death
reporting worksheet as appropriate
 Enter information into hospital Medicare database
 Certification of providers with deficiencies if
acceptable plan of correction
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Interpretive Guidelines
 Starts with a tag number, example A-0001
 “A” refers to the hospital CoPs
 Goes from 0001 to 1163
 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
45
46
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
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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 located
 See proposed changes on telemedicine
 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
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Governing Body (Board) A-0043
 Hospital must have an effective governing body
responsible for the conduct of the hospital as an
institution
 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, etc.)
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Medical Staff and Board
 Board appoints individuals to the MS with the
advice and recommendation of the MS (0046)
 Will review board minutes to make sure they are
involved in appointment of MS
 Board must assure MS has bylaws and they
comply with the CoPs (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
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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 407 and 450
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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
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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.
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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
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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
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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
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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
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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
 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
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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?
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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
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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
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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, revised 7-1-10
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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
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Emergency Services 0091
 Remember to see the EMTALA separate CoP
 Revised May 29, 2009 and amended July 2010
and now 64 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
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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
65
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
66
Patient Rights
Changes 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
67
Patient Rights Standards 0115-0214
 Minimum protections and rights for patients
 Right to notification of rights and exercise of rights
 Privacy and safety
 Confidentiality of medical records
 Restraint issues (50 pages of restraint standards)
 Grievances
 Advance directives
 Visitation rights
68
Standard # 1
 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 fifth grade level
 Must have P&P to ensure patients have information
necessary to exercise their rights
69
Notice of Patient Rights 116
 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 give Medicare patient IM Notice within two
days of admission and in advance of discharge if
more than two days
70
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 (IM Notice) or detailed
notice)
 Right to be free from unnecessary restraints
 Right to determine who visitors will be
71
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
72
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 2011 Patient Centered Communications Standards
73
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 and the five
2011 standard TJC requirements
 If hospital owned physician practices ensure
interpreters are present in prescheduled
appointments
74
Grievance Process A-0118
 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
75
Grievance Process A-0118
 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
76
“Staff Present” Grievances
 Remember it is not a grievance if resolved by “staff
present”
 Document this in medical record
 Expanded definition of what is meant by “staff
present”
 Now includes any hospital staff present at the time of
the complaint or who can quickly be at the patient’s
location
 Such as nursing administration, nursing supervisors,
patient advocates or anyone else who can resolve
the patient’s complaint
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Grievances A-0118
 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
78
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
79
Grievances 0118
 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
80
Grievances 0118
 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
81
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
82
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
83
Grievance Process 0119
 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
84
Grievance Process A-0119
 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
85
Rule #6 A-0119-120
 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
86
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?
87
Grievance Process-A-0120
 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
 QIO are CMS contractors who are charged with
reviewing the appropriateness and quality of care
rendered to Medicare beneficiaries in the hospital
setting
1http://www.qualitynet.org/dcs/ContentServer?pagename=Medqic/MQGeneralPage/GeneralPageTemp
late&name=QIO%20Listings
88
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
89
90
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
91
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
92
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
93
Grievances
 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
94
Grievances A-0123
 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
95
Grievances A-0123
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
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
96
TJC Complaint Standard
 TJC has complaint standard RI.01.07.01 with
changes 7-01-09 and 2 010 and continued in
2011
 Will not cover but provided for reference
 TJC calls them complaints
 CMS calls them grievances
 TJC has eliminated several standards in
2011 that are still CMS standards
 More closely cross walked now
97
RI.01.07.01 Complaints & Grievances
 Standard: patient and or her family has the right to
have a complaint reviewed, (RI 2.120 previously),
 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 C&G
resolution process
 EP4 Complaints must be reviewed and resolved
when possible
98
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
99
RI.01.07.01 Complaints and Grievances
 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
100
RI.01.07.01 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)
101
Have a Policy to Hit All the Elements
102
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
103
Standard #2 Exercise of Rights 0129
 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
104
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
 Patients needing post-hospital care are given
choice home health or nursing homes
 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
105
Rule #2 - Patients Have a Right:
 To make informed decision regarding their
care
 Being informed of their diagnosis and
prognosis
 To request or refuse treatment
 Right to sign out AMA
 Remember EMTALA requirements if patient is
transferred
 Have patient sign the transfer agreement
106
Informed Consent 0131
 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
107
Informed Consent 0131
 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
108
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
109
Disclosures to Patients 131
 There are two disclosures that must be in writing
 If physician owned hospital
 If a doctor or an ED physician is not available 24 hours a
day to assist in emergencies
 Must provide information at beginning of inpatient
stay or visit
 Includes notice in your general consent form/notice
of privacy practice that all inpatients and
outpatients sign
110
Patient Rights 0132
 Right to make and have the advance directives
followed when unconscious or incapacitated
 Staff must provide care that is consistent with
these directives
 P&P must include delegation of patient rights
to representative if patient incompetent
 Note rights as inpatient outpatient AD
requirements of Joint Commission
111
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
 You must provide written information to the patient
on their rights under state law, at time of admission
 Both inpatients and outpatients have rights but
don’t have to give it in writing to outpatients
 Document whether or not they have an AD
112
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
113
Patient Rights
 Includes the right for medical decisions such
as 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
114
3rd Standard Privacy and Safety 143
 The right to personal privacy
 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)
115
Personal Privacy
 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)
 Need consent for video/electronic monitoring
 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
116
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
117
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
118
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
119
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
120
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
121
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
122
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.
123
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
124
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
125
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
126
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
127
Standard #4 Confidentiality
 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
 HIPPA compliant authorization for release
 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
 TJC IM.02.01.01 standard requires that hospital
protects the privacy of health information, maintain
security of same (white boards)
128
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.
129
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
130
5th Standard Restraints 0154-0214
Many changes were made
Combined the two sections on medical
surgical and behavioral restraints into one
section
Changes went into effect January 8, 2007 and
50 pages of interpretive guidelines April 11,
2008 and 10-17-08 and references added 65-09
 Need to rewrite policies and procedures and train
all staff
131
Restraint Worksheet
 CMS has restraint worksheet1 which is not an
official OMB form
 Cannot mandate hospital fill out but will save time on
phone from them asking you the information
 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
132
133
Restraints
 New changes 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
134
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
135
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)
136
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)
137
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
138
Protocols
 Requires an order even with a protocol is
basically the same process hospitals were
doing previously
 Medical record must include documentation
of individualized assessment, symptoms
and diagnosis that triggered protocol
 Need MS involvement in developing and
review and quality monitoring of their use
139
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 July 1, 2009
 10 new standards
 All the 2009 R&S standards were eliminated except
two (forensic and one on behavioral management) for
hospital who use TJC for deemed status
140
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
141
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
142
143
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
144
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
145
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)
146
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
147
Learning From Each Other
 Learning from Each Other - Success stories and
Ideas for Reducing Restraint/Seclusion in
Behavioral Health, tools and forms in appendix
 Published in 2003 by many organizations such as
American Psychiatric Nurses Assn, National
Association of Psychiatric Health Systems
(NAPHS) with support of AHA
 See NAPHS and AHA guiding principles
Sources: www.naphs.org; www.apna.org, www.psych.org, or
www.apna.org, www.naphs.org/catalog/ClinicResources/index.html
148
Restraint and Seclusion
 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
149
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)
150
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 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
151
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
152
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
153
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
154
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
155
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
156
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)
157
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
158
Reasons to Restrain
(Check all that apply)
 Unable to follow directions
 High risk of falls
 Aggressive
 Disruptive/combative
 History of hip fracture/falls
 Self injury
 Interference with treatments
 Removal of medical devices
 Other: ____________________________
159
160
Rule #4
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
161
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
162
Least Restrictive Restraint to More
Side rails…………...
Net bed
Hand mittens……….
soft extremity
restraint
Lap board…………..
Roll belt/lap belt……
2 point soft restraint..
Wrap IV site ………..
Hand mitten………...
Freedom splint is a restraint!
Geri chair
vest restraint
3 or 4 point soft
arm board
soft wrist restraint
163
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
164
Consider Alternatives
Bed sensor
Close to nurses
station
Activity apron
E-Z release hugger
(if can release)
Reality
orientation/familiarize
patients to room
Verbal
instructions/support
Frequent visits with
patient (hourly except
night shift)
165
Consider Alternatives
Skin sleeves
Encourage family visits
Sensor alarm
Pain/discomfort relief
Posey lateral wedges
Diversion activities such
as TV, CDs, DVDs,
music therapy, picture
books, games
Access to call cord
 Lower chairs
 Allow wandering, if possible  Provide structured, quiet
environment
 Food/hydration
 Exercise/ambulate
 Low beds or mattress on
floor
 Toileting routine
166
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
167
Alternatives to Restraints
Watching TV
Massage or family can hire massage
therapist
Punching bag
Avoid sensory overload
Fish tanks
Tapes of families or friends
168
169
170
171
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, PA, but not a medical
student
Remember must specify who in your P&P (168)
172
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
173
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)
174
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
175
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
176
177
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
Debriefing no longer mandated by TJC for
behavioral patients (deemed status)
Can add information on debrief to R&S toolkit
178
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)
179
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
180
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
181
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
182
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
183
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
184
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)
185
Document Type of Restraint
186
187
188
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
189
190
191
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
192
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
193
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
194
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
195
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)
196
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
197
198
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
199
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
restraints on medical patients (which they now call
non-behavioral health patients) every 24 hours
 Not daily but every 24 hours
 CMS and TJC the same
200
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
201
202
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)
203
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
204
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
205
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
206
De-escalation
 Consider document in your tool kit although not required by
CMS or TJC now (deemed status)
 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.
207
208
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)
209
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)
210
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
211
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
212
Training Cost
Individuals doing training program must be qualified
(207)
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
213
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
In fact, in Federal Register recommended sending
one person to CPI training class as a train the
trainer
 1http://www.crisisprevention.com
214
Education Physicians and LIPs
Physician and other LIP training requirements must
be specified in hospital policy (176)
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
215
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
216
Rule #20 1:1 Monitoring R&S 0183
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
217
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
218
Rule #21 Deaths
Report any death associated with the use of
restraint or seclusion
Remember, the 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
219
Rule #21 Deaths 0214
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
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
220
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
221
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
222
Hospital CoPs for QI
CMS issued new hospital COPs for QA and
Performance Improvement
Effective March 25, 2003 and amended 411-08 and 10-17-08 and no changes 6-5-09
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
223
Hospital CoPs for QI)
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
224
CMS Hospital CoPs
Triggers can help hospitals find errors
Trigger tools available on IHI website1
Program must incorporate quality indicator
data including patient data (274)
Look at information submitted to or from
QIO
1www.ihi.org
225
CMS Hospital CoPs
QIO to advance quality of care for Medicare
patients
Sign up with your state QIO to get newsletters and
other information
Use data to monitor safety of services and quality of
care (275)
Identify opportunities for improvement (276)
Board determines frequency and detail of data
collection (277)
Focus on high risk, high volume, or problem prone
(285)
226
QAPI
Must not only track medical errors and adverse
events but also analyze their causes (287, 310)
RCA is one tool to measure causes
Hospital must take action based on data (289) and
measure its success (290)
Example; process hospitals took to get MI patient
timely thrombolytics and timely antibiotics and
blood culture for pneumonia patients
TJC moving toward accountability measures and
CMS toward value based purchasing
227
QAPI
Hospital needs to document and track performance
to make sure improvements are sustained (291)
Continue to track antibiotics given timely in the OR
before surgical procedure and prophylactic treatment
to prevent DVT/PE in major surgery patients
Number of PI projects depends on scope and
complexity of hospital services so large hospital doing
CABG would measure indicators on this
Hospital may want to develop and implement IT
system to improve patient safety and the quality of
care (299)
228
QAPI
Hospital must document what PI projects are being
done and the reason for doing them (301) and
progress on it (302)
Board, MS, and administration are responsible for
and accountable for ongoing program (309)
Decide which are priorities (312) and address
issues to improve patient safety (313)
Clear expectations for patient safety are established
(314)
Need adequate resources for PI and patient safety
(315, 316)
229
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?
230
Next Sections
Medical staff
Dietary
Nursing services
Laboratory services
Radiology
Medical records services
Autopsies
Pharmacy services
231
Medical Staff 482.22(A) 0338
Hospital must have an organized MS that operates
under bylaws approved by Board
May only have one MS for entire hospital campus
(all campuses, provider based-locations, satellites
and remote locations)
Integrated into one governing body with the MS
bylaws that apply equally to all
See previous MS sections 0044-94
These have been discussed previously
232
Medical Staff 0340
MS must periodically conduct appraisals of
its members
 MS bylaws determine frequency of
appraisals
Recommends at least every 24 months (TJC
is 24 months)
To be sure they are suitable for continued
membership
233
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
234
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
235
Medical Staff 0341
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
236
Medical Staff Organization 347
MS is accountable to Board for quality of medical
care provided
If MS has executive committee, majority of
members must be MD/DO
MS must be well organized-formalized
organizational structure and lines are delineated
between the MS and the Board
MS must have bylaws and must enforce bylaws
and Board must approve bylaws
237
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)
238
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)
239
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
240
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
241
H&P 358
Repeated in tag number 461 and 463
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
242
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
243
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
244
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
245
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 (2010)
246
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
247
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
248
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
249
Director of Nursing Service
DON must be RN, A-386 (often referred to as chief
nursing officer)
DON responsible for determining types and
numbers of nursing personnel
DON 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
250
Nurse Staffing 392
Nursing service must have adequate number
of nurses and personnel to care for patients
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
251
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 nurse-patient 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
252
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)
253
Nursing Linked to Safety
Also showed medication error rate, falls,
pressure ulcers, UTI, surgery site infections,
gastric ulcers, codes, LOS, etc. linked to
staffing
Redesigning the work force
See Keeping Patients Safe:Transforming the Work
Environment of Nurses 20041
1www.nap.edu/openbook/0309090679/html/23/html
254
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
255
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
256
RN for Every Patient A-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
257
Nursing Care Plan A-396
Hospital must ensure that nursing staff develop and
keeps a current, nursing care plan for each patient
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
258
Agency Nurses 398
Agency nurses (CMS calls them non-employee
nurses) must adhere to P&P’s
DON 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
259
Preparation/Admin of Drugs 404
Drugs must be prepared and administered
according to state and federal law (404)
Need an practitioner’s order
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
260
Administration of Meds 0405
Medication management is a hot topic with
CMS and TJC
All drugs administered under the supervision of
nursing or other personnel if permitted by law
In accordance with approved medical staff
P&P’s
Surveyor will review sample of medication
records to ensure it conforms to physician’s
order
261
Administration of Meds 0405
Surveyor will make sure medication given within 30
minutes of scheduled time
 So if medication ordered at 9 am must give between 8:30
am and 9:30 am
Check QAPI activities to see if administration of
drugs is monitored
Many hospitals have changed to this 30 minute
time frame but some still have one hour on either
side and feel this is appropriate since only a survey
procedure
262
Physician Order 406
CMS issues standing order memo 10-24-08
Also includes preprinted orders and use of stamps
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
263
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
264
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
265
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
266
Verbal Orders 407
 Verbal orders are a patient safety issue
 Have lead to many errors
 Joint Commission has standard and NPSG, CMS has
standard in CMS hospital CoPs, QIO 7th scope of work,
National Coordinating Council recommendations
 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
 Changed language from prescribing to ordering practitioner
267
CMS Verbal Orders
Emphasizes to be used infrequently and never
for convenience of the physicians
This means that physician should not give verbal
orders in nursing station if he or she can write
them
Can be used in emergency or if surgeon is
scrubbed in during surgery
New regulation broadens category of
practitioners who can sign orders off
268
Verbal Orders P&P Should Include
Limitations on 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
269
Signing Off Verbal Orders
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
270
Verbal Orders
New 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
within 48 hours
Need hospital P&P to reflect these guidelines
Write it down and repeat it back
271
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)
272
Blood Transfusions and IVs 409
Blood transfusions and IV medications must
be administered with state law and MS
bylaws
Must have special training for this and within
scope of practice
Survey procedure- determine if personnel
have special training which should include
fluid and electrolyte imbalance and blood and
blood components, and venipuncture
technique
273
Incident Reports
There must be procedure for reporting
transfusion reactions, adverse drug
reactions and errors in administration of
drugs (410)
Survey procedure - request procedure for
reporting-they may review the incident
reports or other documentation through
QAPI program
274
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
275
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
276
Retention of Record A-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
277
Medical Records
Must be promptly completed and within 30
days
Kept at least 5 years (439) in original,
microfilm, computer memory or other
electronic storage
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
278
Retrieval A-0440
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
279
Confidentiality 441 and 442
Must have a procedure for ensuring
confidentiality of MR
Copies may only be released to authorized
individuals and written authorization by
proper person, DPOA, guardian, etc.
Surveyor will ask for policy
Release only for court orders, subpoenas, in
house education purposes, etc.
280
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
281
Legible and Authenticated 450 6-5-09
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,
initials, computer key, or other code) and a list of
written signatures must be available
282
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
283
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
284
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
285
286
287
288
Verbal Orders 454 and 457
 Recall verbal order section starting in MS section at tag
number 407 is repeated and already discussed
 All doctor can sign VO for any other doctor on case for five
years
 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
 Sign off 48 hours unless state law specifies specific time
frame, even all lab orders
 Can’t sign off within 30 days unless state law is that specific
and not just records be completed within this time frame
289
History and Physical 458 and 461
Repeats same provisions on H&P as in
medical staff section under tag number 358
and 359
H&P done within 24 hours, not older than 30
days old and updated within 24 hours and
updated and on chart before patient goes to
surgery
PA and NP can do if allowed by hospital and all
state laws allow and physician reviews and
authenticates with date, time, and signature
290
MR Must Contain 464 and 465
Must have admitting diagnosis in chart (463)
All consults and findings by clinical staff and others
must be documented (464)
Information must be promptly filed in the MR so
staff has access to it (464)
Must document complications and hospital
acquired 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
291
Informed Consent A-466
Interpretive guidelines issued on April 13, 2007,
and minor changes October 17, 2008
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) and procedures with yes or no
292
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
293
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
294
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
295
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
296
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)
297
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
298
Well designed (optional) may also include:
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
299
Well designed (optional) may also include
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
300
Well designed (optional) may also include:
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
301
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
302
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
303
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
304
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
305
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
306
Pharmacy 0490
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
307
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
308
Pharmacy Policies include:
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 preop orders” is prohibited
Voluntary, non-punitive reporting system to monitor
and report adverse drug events
309
Pharmacy Policies include:
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)
310
Pharmacy Policies Include (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
311
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
312
Pharmacy Management 0491
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
313
Pharmacy Management 491
Drugs stored as per manufacture’s
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
314
Pharmacist A-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
315
Pharmacist A-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
316
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
317
Delivery of Service A-0500
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
318
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
319
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
320
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. Vioxx)
 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
321
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
Staff ensure accuracy in medication preparation
Staff uses appropriate technique to avoid
contamination
322
Compounding of Drugs
Use a laminar airflow hood to prepare any IV
admixture, any sterile product made from nonsterile 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
323
Locked Storage Areas A-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
324
Locked Storage Areas A-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
325
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
326
Securing Medications
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
327
Locked Storage Areas A-254
Saline flushes need to be secure to prevent
tampering so under constant supervision or locked
up
 Consider having safe injection practices P&P and follow
CDC 10 guidelines
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
328
Locked Storage Areas A-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
329
Locked Storage Areas A-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
330
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
331
Securing Medications
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
332
Locked Storage Areas A-254
Saline flushes need to be secure to prevent
tampering so under constant supervision or locked
up
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
333
334
ASA Standards, Guidelines, Statements
These are available off the ASA
website1
Security of medications in the
operating room
See also preanesthesia and post
anesthesia position statements
1http://www.asahq.org/publicationsAndServices
/sgstoc.htm
335
336
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
337
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
338
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
339
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.
340
No Pharmacist on Duty A-0506
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
341
No Pharmacist on Duty A-0506
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
342
Medications Errors A-0508
Hospital must monitor, implement, and enforce the
automatic stop order system
Drug errors, adverse drug reaction, and
incompatibilities must be immediately reported to
the attending MD/D and to the hospital PI program
Definition of med error or ADE should be broad
enough to include NEAR MISSES
Recommend use of definition by National
coordinating council medication error reporting and
prevention definition
343
Medications Errors A-0509
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
344
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?
345
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
346
Formulary A-0511
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
347
Radiology A-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
348
Safety 535
 Proper safety precautions maintained against
radiology hazards
 Including shielding for patients and personnel as
well as storage, use, and disposal of radioactive
materials
 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)
349
Personnel
 Qualified radiologist must supervise ionizing
radiology services
 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 023)
350
Personnel A-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
351
Radiology A-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
352
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
 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
353
Laboratory Services A-0576
 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
354
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
355
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
356
Tissue Specimens A-0584
 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 new chapter in 2009 on transplant safety
and FAQs which continues into 2010
357
Blood Banks A-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
358
359
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)
360
Blood Banks A-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)
361
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
362
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
363
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
364
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
365
Dietary A-618
 Availability of diet manual and therapeutic
diet menus
 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, early/late
trays, nutritional supplements
366
Dietary A-0618)
 Integration of food and dietetic services into
hospital wide QAPI and infection control
programs
 Guidelines on acceptable hygiene practices
of personnel and kitchen sanitation
 Compliance with state or federal laws
367
Organization A-0620
 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
368
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
369
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
370
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
371
Nutritional Assessment 628
 TJC requires to be done within 24 hours
(PC.01.02.03)
 If require artificial nutrition by any means (tube
feeding, TPN)
 If medical or surgical condition interferes with ability
to digest, absorb, or ingest nutrients
 If diagnosis or signs and symptoms indicate a compromised
nutritional status such as anorexia, bulimia,electrolyte
imbalance, dysphagia, malabsorption, ESRD
 Adversely affected by nutritional intake (diabetes, CHF,
taking certain meds)
372
Therapeutic Diets 629
 Therapeutic diets must be prescribed by practitioner in
writing by the practitioner responsible for patient’s care
 Dietician can make recommendations but diet must
be ordered by doctor
 Document in the MR including information about the
patient’s tolerance
 Evaluate for nutritional adequacy
 Manual must be available for nursing, FS, and
medical staff
 Dieticians can only make recommendations and can’t order
373
Nutritional Needs 630
 Must be met in accordance with recognized dietary
practices
 Follow recommended dietary allowances -current
Recommended Dietary Allowances (RDA) or
Dietary Reference Intake (DRI) of Food and
Nutritional Board of the National Research Council
 “Dietary Guidelines for Americans 2005”1
 Surveyor will ask hospital what national standard
you are using
1www.heathierus.gov/dietaryguidelines
374
Next Sections
 Utilization review
 Infection Control
 Discharge Planning
 Organ and Tissue
 Surgery and Anesthesia
 Nuclear Medicine
 Emergency Services
 Respiratory
 Rehab
375
Utilization Review A-0652
 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
376
Two Exceptions
 Hospital has an agreement with the QIO in their
state to assume binding review
 Many hospitals have K with QIO to review admissions,
quality, appropriateness and diagnostic information
related to Medicare inpatients, will look to see signed
contract
 CMS has determined that the UR procedures
established by the state are superior to the ones
required under this section and state requires
hospital to meet UR requirements for Medicaid
program (there are none approved)
377
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
378
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
379
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
380
Scope of Reviews A-0655
 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
381
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)
382
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
383
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
384
Physical Environment A-0700
 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
385
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
386
Life Safety Code
 Separate CoP
 Both Joint Commission and CMS using 2000
version
 Hospitals should do review of LSC for gap analysis
 Joint Commission hospitals will all have separate
life safety surveyor and larger hospitals might have
one for two days
 Also TJC surveyors have had training on LSC
 No cluttered hallways in the nursing units
387
Buildings A-0701
 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
388
Buildings A-0701
 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
389
Buildings
 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
390
Emergency Power and Lighting
 Must be emergency power and lighting in OR,
PACU, ED, and stairwells
 All other areas must have emergency supply source,
battery lamps, and flashlights available
 Must comply with 2000 LSC-National Fire Protection
amendment NFPA 101, and NFPA-99 on Health
care facility for emergency lighting and emergency
power
 Doors with no roller latches, need positive latching
391
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
392
Life Safety from Fire A-709
 Must meet 2000 LSC of the NFPA
 CMS may waive specific provisions, after
consideration by state survey agency, if would
result in unreasonable hardship but only if waiver
will NOT adversely affect the health and safety of
patients
 Must follow state fire and safety code and CMS
may allow surveyor to apply instead of LSC
393
Trash A-0713
 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
1 www.h2e-online.org
394
Fire Control Plan A-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
395
Facilities
 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 drinking, lab water, irrigation - review water quality
monitoring
396
Ventilation, Light, Temperature
 Proper ventilation in areas using ethylene oxide,
nitrous oxide, guteraldehydes, or other hazardous
substances
 Temperature controls in pharmacy and food
preparation
 Ventilation where O2 is transferred, in isolation
rooms and lab
 Adequate lighting in patient rooms and food and
medication preparation areas (shown to reduce
medication errors)
397
Ventilation, Light, Temperature
 Temperature, humidity, and airflow in OR
within acceptable standards to inhibit
bacterial growth
 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
398
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
399
Infection Control)
 TJC has chapter on Infection Prevention and
Control
 APIC 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
400
Infection Control (IC) A-0750
 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
401
Infection Control (IC) A-0747
 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
402
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
403
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 non-regulated waste)
404
IC Officer’s Responsibilities
 Develop and implement IC measures (hospital
staff, contract workers, volunteers)
 Mitigation of risks associated with patient
infections present upon admission and risks
contributing to HAI
 Active surveillance
 Monitoring compliance with all P&Ps, protocols
and other infection control program requirements
405
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
406
Infection Control (IC) A-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)
407
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.
408
409
410
Medical Equipment and Supplies Resources
 Multi-Society Guidelines for Reprocessing
Flexible Gastrointestinal Endoscopes by APIC at
www.apic.org/AM/Template.cfm?Section=Guidelines_and_Standards&template=/CM/ContentDis
play.cfm&section=Topics1&ContentID=6381
 Disinfection of Healthcare Equipment Chapter in
Guidelines for Disinfection and Sterilization in
Healthcare Facilities Nov 2008 at
www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf
 Single Use Device Reprocessing at http://cms.h2eonline.org/ee/waste-reduction/waste-minimization/
411
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, VRE bundle or sepsis
bundle, prompt removal of foley catheter
 Disinfectants, antiseptics, and germicides must be used in
accordance with manufacturers instructions
412
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.
413
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
414
Log of Incidents 750
 Must maintain a log related to infections and
communicable diseases, including HAI
 Includes information from patients and staff so need
information from employee health nurse
 Includes employees, contract staff such as agency
nurses, and volunteers
 Includes surgical site infections, patients or staff with
MDRO, patients who meet isolation requirements
 Log can be paper or electronic, TJC IC.01.01.01
415
CEO, DON, and MS A- 756
 The CEO, DON, and MS must ensure that
there is hospital wide QA 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
416
Discharge Planning A-800
 Must have a discharge planning process that
applies to all patients (inpatients and outpatients)
 P&P must be in writing
 Written discharge planning process must reveal a
clear process to be followed
 Necessary to prevent readmission
 Surveyor will review patient care plans for discharge
planning interventions
417
Identification of Patients 806
 Must identify at early stage of hospitalization, all
patients who are likely to suffer adverse
consequences if no discharge planning
 No national tool to do this
 May include factors as functional status,
cognitive ability and family support
 Patients at high risk should be identified from
screening process
418
Discharge Planning Evaluation
 Hospital must provide a discharge planning evaluation to
patients or upon the request of the physician
 Needs assessment can be formal or informal
 Assess factors on what the patient will need when
discharged; bio-psychosocial needs and patient and
caregiver’s understanding of discharge needs
 Can be a tool or protocol
 Surveyor will ask how patients are made aware of their right
to request a discharge plan
 Are they given the pamphlet “important message from
Medicare”
419
Discharge Planning Responsibility
 RN, SW, or qualified person must develop and
supervise the development of the evaluation (807)
 Person who does discharge planning evaluation
needs to have experience and knowledge of social
and physical factors that affect functional status to
meet patient needs (emphysema -coordinate
respiratory therapy, nursing care, financials for
home health)
 Ideally, discharge planning is interdisciplinary
process
420
Evaluation 809
 Discharge planning evaluation must include
likelihood of needing post-hospital services
and availability of services
 Keep complete file on community based
services such as LTC, sub acute care, and
home care
 Is physical, speech, OT or RT needed
 Use QAPI program to determine if discharge
planning process is effective
421
Self Care Evaluation
 Discharge planning evaluation must include if
patient can do self care and return to pre-hospital
environment
 Willingness of patient and family to do
 Inform patient of freedom to choose providers or
post hospital care (823)
 Give list of Medicare certified HHA that serve your area
(SSA 1861) including ownership information
 Must assess if need hospice and give list of Medicare
certified hospices and LTC (809)
 Counsel patient and family for post hospital care (822)
422
Discharge Plan
 If in MCO hospital must indicated which ones have
contract with home health or LTC (825)
 Hospital must now document in the medical record
that the list of home health or LTC facilities was
presented to the patient (827)
 Rewrite your P&P to include this
 Hospital must inform patient of freedom to choose
post hospital provider (828) and respect their
wishes (829)
 HHA must request to be on the list
423
Timely Discharge Evaluation
 Hospital must complete the evaluation timely
 So appropriate arrangements can be made
 Assessment should start soon after admission
 Surveyor will review several patient discharge
plans for appropriate coordination of health and
social resources
 Also need to reassess discharge planning process
on an ongoing basis (843)
424
Transfer or Referral 837
 Must transfer or refer patients to appropriate
facilities, agencies, or outpatient services for follow
up care
 Must send along necessary medical records
 Make sure patients get appropriate post hospital care
 Must document if patient refuses discharge
planning services
 Written authorization before release of information
425
Organ, Tissue, and Eye A-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
426
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
427
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
428
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
429
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
430
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
431
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
432
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)
433
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
434
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
435
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
436
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
437
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
438
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
439
Surgery Policies 951
 Aseptic and sterile surveillance and practice,
including scrub technique
 Id of 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
440
Surgery Policies A-0951
 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
441
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
442
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
443
H&P A-0952
 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
444
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
445
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
446
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
447
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
448
Surgery Equipment A-0956
 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
449
PACU 957
 Must be adequate provisions for immediate postop care
 Must be in accordance with acceptable standards
of care
 Separate room with limited access
 P&P specify transfer requirements to and from
PACU
 PACU assessment includes level of activity,
respiration, BP, LOC, patient color (Aldrete)
 Follow ASPAN standards
450
OR Register A-0958
 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
451
Operative Report A-959
 Name and id of patient
 Date and time of surgery
 Name of surgeons, assistants
 Pre-op and post-op diagnosis
 Name of procedure
 Type of anesthesia
452
Operative Report A-959
 Complications and description of
techniques and tissue removed
 Grafts, tissue, devises implanted
 Name and description of significant
surgical tasks done by others (see listopening, closing, harvesting grafts
453
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
454
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
455
4th Change Effective February 14, 2011
456
CMS Added FAQs
457
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
458
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
459
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
460
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
461
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.
462
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.
463
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
464
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
465
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
466
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)
467
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.
468
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
469
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)
470
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
471
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
472
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
473
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
474
475
476
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
477
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
478
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
479
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
480
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.
481
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
482
Post-Anesthesia Assessment to Include
 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
483
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
484
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
485
486
American Association of Nurse Anesthetists
 AANA has excellent website1
 Information on how to become a CRNA
 Has position statement on documenting the
standard of care for the anesthesia record
 Sample forms
1www.aana.com/resources.aspx?ucNavMenu_TSMenuTargetID=51&ucNavMenu_TSMenuT
argetType=4&ucNavMenu_TSMenuID=6&id=713
487
488
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!)
489
490
491
492
Nuclear Medicine A-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
493
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.
494
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
495
Nuclear Med
 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
496
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
497
Outpatient Services A-1076
 Services must meet the needs of the patient
 Optional service
 Must be in accordance with standards of practice
 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
498
Outpatient Services
 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
499
Outpatient Services
 Assign person responsible for this dept.
 Have appropriate professional and
nonprofessional personnel
 Define in writing the qualifications and
competencies necessary to direct the department
 Will review P&P to determine person’s
responsibility
 Need to be sure that one person is overlooking all
of ambulatory patients care and treatment (1079)
500
Outpatient Tag 1079
 The outpatient services department must be
accountable to a single individual
 who directs the overall operation of the hospital’s
entire outpatient services (all locations, all
outpatient services).
 Survey Procedures 482.54(b)
 Verify that one person is assigned to manage and
be responsible for outpatient services.
 Review the organization’s policies and procedures
to determine the person’s responsibility.
501
Emergency Services A-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
502
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
503
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
504
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
505
Rehab Services A-1123
 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
506
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
507
Rehab Services
Must be given in accordance with order
of practitioner (no longer says physician
only)
Orders must be incorporated in the
medical record
Plan of care must meet criteria such as
based on assessment, measurable
short and long term goals, updated as
needed
508
Respiratory Services A-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
509
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
 Procedure to follow for adr
 Therapeutic percussion and vibration
 Bronchopulmonary drainage
510
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
511
Respiratory Services 1163 (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
 Will review medical records
 Will review to make sure all required policies
and procedures are written
512
 Statement of Deficiencies and Plan of
corrections
 Based on documentation of surveyor
worksheet or notes and form CMS-2567
513
Condition Level Requirement Noncompliance
514
The End
Questions?
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
Medical Legal Consultant
5447 Fawnbrook Lane
Dublin, Ohio 43017
614 255-7163
sdill@thedoctors.com
515
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
516
Websites (continued)
 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
517
Websites (continued)
 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
518
Websites (continued)
 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
519
Websites (continued)
 CMS Life Safety Code page http://new.cms.hhs.gov/CFCsAndCoPs/07_LSC.
asp
 COPs available in word and PDR at
http://www.access.gpo.gov/nara/cfr/waisidx_04/4
2cfr485_04.html
 American College of Radiology- www.acr.org
 Federal Emergency Management Agency
(FEMA)- www.fema.gov
520
Websites (continued)
 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.ama-assn.org/med-sci/npsf/htm
 The Institute for Safe Medication Practices www.ismp.org
521
Websites (continued)
 U.S. Pharmacopeia (USP) Convention, Inc. 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
522
Websites (continued)
 Sentinel event alerts at www.jointcommission.org
 American Pharmaceutical Association www.aphanet.org
 American Society of Heath-System Pharmacists www.ashp.org
523
Websites (continued)
 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
524
Infection Control Websites
 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
525
Infection Control Websites (continued)
 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
526
Resources
 To obtain a copy of Survey and Certification Memo 9-10
go to the CMS website at
www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/item
detail.asp?filterType=dual,%20date&filterValue=30|d&filte
rByDID=1&sortByDID=4&sortOrder=ascending&itemID=CMS1216
415&intNumPerPage=10
 To see a copy of the final interpretive guidelines issued
on October 17, 2008 for hospitals, Appendix A (the
regular hospital conditions of participation) which is also
part of the State Operations Manual (SOM) go to
www.cms.hhs.gov/transmittals/downloads/R37SOMA.pdf
527
The End Questions
Sue Dill Calloway RN, Esq.
CPHRM
AD, BA, BSN, MSN, JD
Medical Legal Consultant
5447 Fawnbrook Lane
Dublin, Ohio 43017
614791-1468
sdill1@columbus.rr.com
528