What PPS Hospitals Need to Know
 Sue Dill Calloway RN, Esq.
 President of Patient Safety and
Education Consulting
 Board Member
Emergency Medicine Patient
Safety Foundation
 614 791-1468
You Don’t Want One of These
The Conditions of Participation (CoPs)
 Many revisions since manual published in 1986
 Manual updated January 31, 2014
– Many changes June 7, 2013
 First regulations are published in the Federal
Register then CMS publishes the Interpretive
Guidelines and some have survey procedures 2
 Hospitals should check this website once a month
for changes
Subscribe to the Federal Register
CMS Survey and Certification Website
Click on Policy & Memos
CMS Issues Many Changes in 2013
 CMS publishes 165 page final regulations changing
the CMS CoP
 Published in the May 16, 2012 Federal Register and
final interpretive guidelines published 3-15-2013
and effective June 7, 2013
 CMS publishes to reduce the regulatory burden on
hospitals-more than two dozen changes
 Published other changes since then
 Includes changes regarding plan of care, restraint
and seclusion, drug orders, verbal orders, blood
transfusions, IV medications, and standing orders
CMS Updates to Manual
Feb 4, 2013 Proposed Changes
 CMS issues 114 pages related to proposed
changes to the CMS CoP
 Hospital privileges for RD to write diet orders
 Board must consult with chief medical officer for
each individual hospital rea quality of medical care
provided in the hospital
 Confirmed each hospital must have separate
medical staff
 MS can include PharmD, dieticians, PA, NP, etc.
 No requirement for board to include MD/DO
Feb 4, 2013 Proposed Changes
 Allow practitioners not on MS to order outpatient
 Allow in-house preparation of radiopharmaceuticals
on off hours without a physician or a pharmacist being
 3 changes for hospitals that are transplant centers
 ASC change for radiology services incident to the surgery
 Swing beds move to Part D so accreditation organizations
can survey
 CAH P&P committee deleted requirement for non staff
member requirement
Feb 4, 2013 Proposed Changes
How to Keep Up with Changes
First, periodically check to see you have the
most current CoP manual1
Once a month go out and check the survey
and certification website
Once a month check the CMS transmittal
Have one person in your facility who has this
Location of CMS Hospital CoP Manual
New website
CMS Hospital CoP Manual
CMS Survey Memos Issued
 Survey memo issued March 15, 2013 with changes
 Privacy and confidentiality memo on March 2, 2012
 Complaint manual updated April 19, 2013
 Access to hospital deficiency data March 22, 2013
 Use of insulin pens issue May 18, 2012
 Single dose June 15, 2012, Humidity in OR 2013
 Discharge planning rewritten May 17, 2013
 Reporting to internal PI March 15, 2013
 Luer Misconnections March 8, 2013, Equipment Dec12,
Luer Misconnections Memo
 CMS issues memo March 8, 2013
 This has been a patient safety issues for many
 Staff can connect two things together that do not
belong together because the ends match
 For example, a patient had the blood pressure
cuff connected to the IV and died of an air
 Luer connections easily link many medical
components, accessories and delivery devices
Luer Misconnections
PA Patient Safety Authority Article
June 2010 Pa
Patient Safety Authority
ISMP Tubing Misconnections
TJC Sentinel Event Alert #36
CMS Hospital Worksheets Third Revision
 October 14, 2011 CMS issues a 137 page memo in the
survey and certification section
 Memo discusses surveyor worksheets for hospitals by
CMS during a hospital survey
 Addresses discharge planning, infection control, and
 It was pilot tested in hospitals in 11 states and on May
18, 2012 CMS published a second revised edition
 Piloted test each of the 3 in every state over summer 2012
 November 9, 2012 CMS issued the third revised
worksheet which is now 88 pages
CMS Hospital Worksheets
 Will select hospitals in each state and will complete
all 3 worksheets at each hospital
 This is the third and most likely final pilot and in
2014 will make some revisions and CMS will use
whenever a validation survey or certification survey
is done at a hospital by CMS
 Third pilot is non-punitive and will not require action
plans unless immediate jeopardy is found
 Hospitals should be familiar with the three
Third Revised Worksheets
CMS Hospital Worksheets
 The regulations are the basis for any deficiencies
that may be cited and not the worksheet per se
 The worksheets are designed to assist the
surveyors and the hospital staff to identify when
they are in compliance
 Will not affect critical access hospitals (CAHs) but
CAH would want to look over the one on PI and
especially infection control
 Questions or concerns should be addressed to
Access to Hospital Complaint Data
 CMS issued Survey and Certification memo on
March 22, 2013 regarding access to hospital
complaint data
 Includes acute care and CAH hospitals
 Does not include the plan of correction but can request
 Questions to
 This is the CMS 2567 deficiency data and lists the
tag numbers
 Updating quarterly
 Available under downloads on the hospital website at
Access to Hospital Complaint Data
 There is a list that includes the hospital’s name and
the different tag numbers that were found to be out
of compliance
 Many on restraints and seclusion, EMTALA, infection
control, patient rights including consent, advance
directives and grievances
 Two websites by private entities also publish the
CMS nursing home survey data
 The ProPublica website for LTC
 The Association for Health Care Journalist
(AHCJ) websites for hospitals
Access to Hospital Complaint Data
Can Count the Deficiencies by Tag Number
Lists by State and Names Hospitals
Complaint Manual Update
 CMS issues memo on April 19, 2013
 CMS updates the Complaint Manual
 Hospital found to be in immediate jeopardy could have
a full validation survey if the RO requests it
 Regional office has discretion
 Hospital can be placed on 23 or 90 days termination
track depending on if IJ removed
 GAO emphasized need to share complaint information
and SA survey finding with the applicable accreditation
agency and CMS agrees
Complaint Manual Update
TJC Revised Requirements
 TJC has published many changes over the past two
 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
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
 Hospitals accredited by TJC, AOA, CIHQ, or DNV
Healthcare have what is called deemed status
 These are the only 4 that CMS has given deemed status
to for hospitals and possible 5th one called AAHHS
 This means you can get reimbursed without going
through a state agency survey
 States can still institute a survey and be more restrictive
CMS Hospital CoPs
 All Interpretative guidelines are in the state
operations manual and are found at this website1
 Appendix A, Tag A-0001 to A-1164 and 456 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
Location of CMS Hospital CoP Manual
All the manuals are at
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
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
Note that when changes are published in
the Federal Register or CMS Survey
Memo there is always the name and
phone number of a contact person at
CMS to contact for questions
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
CMS Required Education
 These will be discussed throughout presentation:
 Restraint and seclusion (annual)
 Abuse, neglect and harassment (annual)
 Infection control, Advance directive
 Medication errors, drug incompatibility and ADR
 Organ donation, standing orders & protocols
 IVs and blood and blood products P&P, medication
 ED common emergencies, IVs and blood and blood
products for ED
What’s Really Important
 Life Safety Code Compliance
 Infection Control and CMS received $50 million
grant to enforce and now HHS gets 1 billion
 Patient Rights especially R&S and grievances
 Performance Improvement (CMS calls it QAPI)
 Medication Management
 Dietary and cleanliness of dietary
 Infection control issues in dietary is big!
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
 Note the CMS Deficiency Memo
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
Survey Protocol
 Survey done through observation, interviews,
and document review
 Usually surveys are done Monday - Friday
but can come on weekends or evenings
 Federal law allows CMS or department of
health surveyors access to your facility
 CAH rehab or psych (behavioral health) is
surveyed under this section even though
CAH has a separate manual
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
 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
Interpretive Guidelines
 Starts with a tag number, example A-0001
 “A” refers to the hospital CoPs
 Goes from 0001 to 1164
 The three sections from Federal Register (CFR)
include the regulation, interpretive guidelines and
survey procedure
 Survey procedure
 Not in every section
 Explains survey process, policies that will be reviewed,
questions that will be asked and documents reviewed
New website for all manuals
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
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
 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
Governing Body (Board) A-0043 2013
 Hospital must have an effective governing body that
is legally responsible for the conduct of the hospital
 Can share a board in hospital system now
 Written documentation identifies an individual as
being responsible for conduct of hospital operations
 Board makes sure MS requirements are met
 Board must determine which categories of practitioners
are eligible for appointment to medical staff (MS), as
allowed by your state law; CRNA, NP, PA’s, nurse
midwives, chiropractors, podiatrists, dentists, registered
dietician, clinical psychologist, PharmD, social worker
Governing Body (Board) A-0043 2013
 No survey of hospital systems
 Can’t just have one policy for the system
 Each individual hospital can use a hospital system’s
policy but they must individually adopt it
 Such as hospital A adopts the policy of XX
 Hospital must be clear that their hospital has
elected to adopt any specific policy
 Minutes need to be clear of one board for two
Governing Body (Board) A-0043 2013
 Each hospital must have their own CNO
 Cannot have one integrated nursing service
department between two separate hospitals just
because they are in the same healthcare system
 It is possible to have one CNO to run two
hospitals if able to carry out the duties of each
 System may chose to operate QAPI program at the
system level but each certified hospital must have
its own PI data with AE and standardized indicators
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
 TJC MS.01.01.01 as to what goes into a bylaw or R/R
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, 457, and 450
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
Medical Staff 2013
 Previous CMS regulations may limit access by
requiring physicians to co-sign orders
 Changes would eliminate some of the barriers
 This change will allow hospitals to more fully utilize
practitioners skills such as NP or PharmD
 Podiatrist could serve as president of the MS
 Others C&P still have to follow the MS bylaws and
 Can have categories in MS but MS must still
examine credentials
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
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
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
 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
 Medical staff makes a recommendation to do use a
distant site to C&P physicians
 Board agrees and must enter into agreement with
distant site hospital (DSH) or distant site
telemedicine entity (DSTE)
 CMS says what must be in the agreement to make
sure the hospital is in compliance with the CoPs
 Must be licensed in that state
 Provide evidence of C&P and provides copy of their
 Hospital can rely on the C&P decision of the
 The hospital must report to the distant site any
complaints received or information on adverse
 Can have one file with telemedicine physicians
or can keep separate file
 Surveyor will look at documentation indicated that it
granted privileges to each telemedicine physician or
that it relied on the distant site entity to do this
 Board must appoint a CEO who is
responsible for managing the hospital
 Verify CEO is responsible for managing entire
 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
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
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
 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
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?
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
 Must be submitted for review
 TJC has similar standards in its leadership chapter
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
Contracted Services
 Board responsible for services provided in hospital
 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
Contracted Services
 Board must ensure services performed under
contract are performed in a safe and efficient
 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
 Consider adding section to all contracts to address CoP
Emergency Services 0091
 Remember to see the EMTALA separate CoP
 Revised May 29, 2009 and amended July
2010 and now 68 pages
 Consider doing yearly education on EMTALA
to your ED staff and for on call physicians
 If hospital has an ED, you must comply with
section 482.55 requirements
 If no ED services, Board must be sure hospital has
written P&P for emergencies of patients, staff and
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
 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
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
Patient Rights
Many standards related to grievances
and restraint and seclusion (R&S)
Sets forth standards regarding R&S staff
training and education
Sets forth standards on R&S death
TJC also has chapter on 14 patient rights or
RI “Rights and Responsibilities of the
Individual” starting with RI.01.01.01 thru
Number of Deficiencies
Nov 2013
Tag Number
Restraint and Seclusion 746
904 Tag 154-217
Care in a Safe Setting
450 Tag 144
Consent & Decision
419 Tag 118-123
189 Tag 131-132
Freedom from Abuse & 166
Notice of Patient Rights 121
275 Tag 145
Care Planning
121 Tag 116 and
Tag 130
Number of Deficiencies
Nov 2013 Jan 2014 Tag Number
Privacy and Safety
142 and 143
146 and 147
Access to Medical
Admission Status
Exercise of Patient
Total 2303
Standard # 1 Notice of Rights
 Notice of Patient Rights and Grievance Process
 Hospital must ensure the notice of patient rights are
 Provide in a manner the patient will understand
 Remember issue of limited English proficiency
(LEP) as with patients who does not speak
English and low health literacy
 20% of patients read at a sixth grade level
 Must have P&P to ensure patients have information
necessary to exercise their rights
Notice of Patient Rights 117 10-7-11
 Rule #1 - A hospital must inform each patient of the
patient’s rights in advance of furnishing or
discontinuing care
 Must protect and promote each patient’s rights
 Must have P&P to ensure patients have information
on their rights and this includes inpatients and
 Must take reasonable steps to determine patient’s
wishes on designation of a representative
 Must give Medicare patient IM Notice within two days of
admission and in advance of discharge if more than two
Designation of Representative 117
 If patient is not incapacitated and has an individual
to be their representative then the hospital must
provide the representative with the notice of patient
rights in addition to the patient
 Patient can do orally or in writing which author suggests
 If the patient is incapacitated then the notice of
patient rights is given to the person who represents
with an advance directive such as the DPOA
 If incapacitated and no advance directive then to
the person who is spouse, domestic partner, parent
of minor child, or other family member
Designation of Representative 117
 This person is known as the patient
 You can not ask for supporting documentation
unless more than one individual claims to be
their representative
 If hospital refuses the request of an individual to
be the patient’s representative then must
document this in the medical record
 States can specify a state law for doing this
 Hospital must adopt P&P on this
Notice of Patient Rights
 Confidentiality and privacy
 Pain relief
 Refuse treatment and informed consent
 Advance directives
 Right to get copy for Medicare patients of Important
Message from Medicare such as the IM Notice or
detailed notice
 Right to be free from unnecessary restraints
 Right to determine who visitors will be
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
 Have sentence that patient acknowledges receipt of
their patient rights
 Right to contact the QIO or state agency of
 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
 See TJC Patient Centered Communications Standards
 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
 Review your policy and procedure and the five
standard TJC requirements
 If hospital owned physician practices ensure
interpreters are present in prescheduled
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
 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
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
 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
Grievances A-0118
 Hospitals should have process in place to deal with
minor request in more timely manner than a written
 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
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
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
 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
Grievances 0118
 If complaint is telephoned in after patient is
dismissed then this is also considered a
 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
Grievance Process - Survey Procedure
 Review the hospital policy to assure its
grievance process encourages all personnel
to alert appropriate staff concerning
 Hospital must assure that grievances
involving situations that place patients in
immediate danger are resolved in a timely
 Conduct audits and PI to make sure your
facility is following its grievance P&P
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
 Remember to add email address and address of
 Document that this is given to the patient
 Remember the TJC APR requirements
 Should be in writing in patient rights section
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
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
Rule #6 A-0119-120
Board Review
 The hospital’s board must review and resolve
 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
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
Does hospital apply what it learns?
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
IM and Detailed Notice Forms
 Hospital to provide a Medicare patient with an Important
Message from Medicare ( IM notice ) within 48 hours of
 The hospital must deliver to the patient a copy of this signed
form again if more than two days and within 48 hours of
 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
Grievance Procedure 121
 Hospital must have a clear procedure for the
submission of a patient’s written or verbal
 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
 Must establish process for prompt resolution of
Hospital Grievance Procedure 0122
Rule #8 – Hospital must have a P&P on
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
 The written notice to the patient must include the
steps taken to investigate the grievance, the results
and date of completion
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
Grievances 7 Day Rule
 Timeframe of 7 days would be considered
appropriate and if not resolved or
investigation not completed within 7 days
must notify patient still working on it and
hospital will follow up
 Most complaints are not complicated and do not
require extensive investigation
 Will look at time frames established
 Must document if grievance is so complicated it
requires an extensive investigation
Grievances Written Response 123
 Explanation to the patient must be in a manner
the patient or their legal representative would
 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
Grievance 123
CMS says if patient emailed you a complaint,
you may email back response
 Be careful as many hospital policy on security do not
allow this since email is not encrypted
 Under HIPAA patient can agree to increased risks
Must maintain evidence of compliance with
the grievance requirements
Grievance is considered resolved when
patient is satisfied with action or if hospital
has taken appropriate and reasonable action
TJC Complaint Standard
TJC has complaint standard RI.01.07.01
Will not cover but provided for reference
TJC calls them complaints
CMS calls them grievances
TJC has eliminated several standards
in that are still CMS standards
More closely cross walked now
RI.01.07.01 Complaints & Grievances
 Standard: Patient and or her family has the right to
have a complaint reviewed,
 EP1 Hospital must establish a complaint and
grievance (C&G) resolution process
 See also MS.09.01.01, EP1
 EP2 Patient and family is informed of the grievance
resolution process
 EP4 Complaints must be reviewed and resolved
when possible
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
 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
RI.01.07.01 TJC Complaints
 EP 17 Board reviews and resolves grievances
unless it delegates this in writing to a grievance
committee (eliminated but still CMS requirement)
 EP 18 Hospital provides individual with a written
notice of its decision which includes (DS);
 Name of hospital contact person
 Steps taken on behalf of the individual to investigate the
 Results of the process
 Date of completion of the grievance process
RI.01.07.01 TJC Complaints
EP19 Hospital determines the time frame
for grievance review and response(DS)
EP20 Process for resolving grievances
includes a timely referral of patient
concerns regarding quality of care or
premature discharge to the QIO
EP21 Board approves the C&G process
(eliminated but still CMS standard)
Have a Policy to Hit All the Elements
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
 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
Standard #2 Exercise of Rights 0130 10-7-11
 Rule #1 – Patients have the right to
participate in the development and
implementation of their plan of care
 Includes inpatients and outpatients
 Includes discharge planning and pain
 Requires hospital to actively include the
patient in developing their plan of care
including changes
Patient Representative
 Repeats that hospital expected to take reasonable
step to determine patient’s wishes on designation of
a representative with same requirements
 Same standard and if patient is not incapacitated
and has a representative then must involve both in
development and implementation of a plan of care
 If incapacitated and AD then this person is involved
 If incapacitated and no AD then to who claims to be
patient representative and can not ask for
supporting documentation unless two claim to be
the representative
Patient Representative
Same requirements about documenting any
refusals to let someone be the representative
in the medical record
Same requirement to follow any specific state
Need P&P on this and should teach staff this
 Policy must facilitate expeditious and nondiscriminatory resolution of disputes about whether
the person is the patient’s representative
Patient Participate in Plan of Care
 If patient refuses to participate, document this
 Include patient’s legal representative if patient minor
or incompetent
 Plan of care is frequently cited
 Do not need a separate plan of care for nursing if
participates in interdisciplinary plan of care
 Patients needing post-hospital care are given choice
home health or nursing homes in writing
 Includes choice to pain management, patient care
issues, and discharge planning
 Section 1802 of SSA guarantees free choice by Medicare patients for
LTC or home health
Rule #2 - Patients Have a Right:
 To make informed decision regarding their
 Being informed of their diagnosis
 To request or refuse treatment
 Right to sign out AMA
 Remember EMTALA requirements if patient is
 Have patient sign the transfer agreement
Informed Consent 0131 12-2-11
 CMS has 3 sections in the hospital CoP manual on
informed consent
 Section on informed consent in patient rights on informed
decisions, medical records and surgical services
 The patient has the right to make informed
 Same provisions related to the patient
representative as before so if competent patient has
a patient representative then you give information to
both regarding the information required to make an
informed decision about the care
Patient Representative and Consent
 CMS specifically states that the hospital must obtain
the written consent of the patient representative of a
patient who is not incapacitated
 Continues throughout the inpatient hospitalization or the
outpatient encounter
 Same provisions related to the patient who is
incapacitated as to whether they have a DPOA and
if not then to their patient representative
 If no advance directives the hospital can not ask the
representative for supporting documentation unless
two people claim to be the representative
Informed Consent 131
 Right to delegate the right to make informed
decisions to another (DPOA, guardian)
 Patient has a right to an informed consent for
surgery or a treatment
 Right to be informed of health status and to be
involved in care planning and treatment
 Informed decision on discharge planning to post
acute care
 Right to request or refuse treatment and P&P to
assure patient’s right to request or refuse treatment
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
 Required to have policies and procedures on
all of these
Disclosures to Patients 131 10-7-11 & 2013
There are two disclosures that must be in
 If physician owned hospital
–Surveyor is suppose to ask to ensure disclosed
–Must give to inpatients and observation
patients now and P&P required
 If a doctor or an ED physician is not available 24
hours a day to assist in emergencies
– Individual notice does not have to be given to the ED
patients but must post a sign
Disclosures to Patients 131
 Posted sign in DED must says hospital does not
have a MD/DO 24 hours a day
 Must discuss how hospital is going to meet the needs of
the patient and hospital P&P required
 Patient must sign an acknowledgment if admitted
 Must provide information at beginning of inpatient stay
or visit
 Physicians who refer patients to the hospital they have an
ownership interest must disclose this and hospital requires
this as a condition for the physician being credentialed or
 Patients seen in PAT should receive this information then
Patient Rights 132
 Patient has the right to make and have the
advance directives followed when incapacitated
 Staff must provide care that is consistent with
these directives
 P&P must include delegation of patient rights to
representative if patient incompetent
 In addition patient may designate in the AD a
support person to make decision on visitation
 Note rights as inpatient outpatient AD
requirements of Joint Commission
Advance Directives
 Your policy should have clear statement of any
limitations such as conscience
 At a minimum, clarify any difference between facility wide
conscience objections and those raised by individual doctors
 But can not refuse to honor designation of a DPOA, support
person or patient representative
 You must provide written information to the patient on
their rights under state law, at time of admission as
an inpatient
 Same notice to 3 types of outpatients; ED, observation or
same day surgery
 Document whether or not they have an AD
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
 Staff on P&P and community
Patient Rights
 Includes the right for DPOA to medical
decisions when patient incapacitated such
as informed consent or pain management
 Disseminate policy on advance directive,
identify state authority permitting an
 Includes Psychiatric or behavioral health AD
 The visitation regulations are one of the
newest patient rights
Family Member & Doctor Notified 133
 The patient has a right to have a family member or
representative notified and their physician notified
on admission if not aware
 Must now ask every patient on admission and document
 Must do so promptly when patient responds affirmatively
 If patient incapacitated must identify a family
member or representative to promptly notify
 If someone comes with patient or arrives after and
asserts they are the patient’s representative then
hospital accepts this
 Same if two people claim to be their representative & follow state law
Privacy & Confidentiality Memo 3-2-12 Tag 143
3rd Standard Privacy and Safety 143
 Standard: The patient has a right to personal
privacy while within the hospital
 To receive care in a safe setting
 To be free from all forms of abuse or
 Rule #1 – The right to personal privacy
 Right to respect, dignity, and comfort
 Privacy during personal hygiene activities
(toileting, bathing, dressing, pelvic exam)
Personal Privacy
 Need consent for video/electronic monitoring
 Must exist clinical need to do this
 Make sure patient is aware and can see camera
 Such as cameras in patient rooms (sleep lab, ED
safe room, eICU) and not in hallways or lobbies
 Include in your general admission consent form that
all patients sign on admission or make sure patients
are aware such in ICU
 May use to monitor patients who are violent and or
self destructive who are in both restraint and
Personal Privacy & Confidentiality 143
 Person not involved with care may not be present
while exam is being done unless consent required
(medical students who are observing not those caring
for patient)
 Information in directory may not be disclosed without
informing patient in advance
 Visitor must ask for the patient by name
 Can use information for payment and healthcare
 Must have P&P that restrict access to MR to those
who need to know such as nurse who takes care of
Personal Privacy & Confidentiality 143
 Discusses incidental uses and disclosures
 Names on spine of chart
 Names on outside of rooms
 Whiteboards that list patient present in OR or PACU
 Take reasonable safeguards
 Ask waiting patients to stand back a few feet from a
counter used for patient registration
 Speak quietly if patient in semi-private room
 Passwords on computers
 Limit access to areas with light boards or white boards
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
Privacy and Safety 144
 Rule #2 – The right to receive care in a safe
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
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
 Review policies and procedures
 How does facility have P&P to curtail
unwanted visitors or contraband materials
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
Privacy and Safety 145
Consider annual training in yearly skills
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
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
 Remember TJC has standard and definitions,
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
 Investigate all allegations of abuse or neglect
 Do not hire persons with record of abuse or
 Report all incidents to proper authority, board
of nursing, etc.
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
 Protect during investigation
 Investigate and report and respond
Abuse and Neglect
Make sure you have a policy in place for
investigating allegations of abuse
Make sure staffing sufficient across all
Make sure appropriate action taken if
Make sure staff know what to do if they
witness abuse and neglect
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
 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
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
Privacy & Confidentiality Memo 3-2-12 Tag 147
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
 Minimal necessary standard such as abstract out
information on child abuse and don’t give protective
services the entire chart
 MR are kept secure and only viewed when
necessary by staff involved in care
 Do not post patient information where it can viewed
by visitors
Standard #4 Confidentiality
 TJC IM.02.01.01 standard requires that hospital
protects the privacy of health information, maintain
security of same (white boards)
 If white board visible to public hospital may use first
name and first initial of last name
 Must protect patient’s medical record information
from unauthorized person
 Must have a policy and procedure on this
 Obtain patient or patient representative written
authorization to disclose medical record information
Patient Records
 Rule #2 – Patients have the right to access
the information contained within their medical
 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.
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
 Reasonable cost for copying, postage or
 No retrieval fee allowed under federal law
5th Standard Restraints 0154-0214
 R&S standards are 50 pages long
 Report deaths in a restraint or within 24 hours of
being in a restraint
 Report also to the regional office if restraint
cause death within 7 days
 Do not need to report death if patient had on only
2 soft wrist restraints and deaths not due to the
 Use revised R&S form
Restraint Patient Safety Brief
Restraint Worksheet
 CMS has restraint worksheet1 which is an official
OMB form
 Not required for two soft wrist restraints if does not cause
 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
Reporting Deaths Unless 2 Soft Wrist Restraints
Regulations only affect regular hospitals
and Critical Access Hospitals have own
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
Standard #5 Restraints
Rule #1 – Patients have a right to be free
from physical or mental abuse, and corporal
 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
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
If patient falls do not consider using R&S as
routine part of fall prevention (154)
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)
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
Restraint Standards
 If a patient becomes violent or has self
destructive behavior (V/SD) in the ICU or ED,
CMS has one set of standards that apply
 Decision to use R&S is not driven from diagnosis
but from assessment of the patient
 TJC standards changed rewritten July 1, 2009 to be
cross walked to the CMS guidelines
 10 new standards adopted
 All the R&S standards were eliminated in 2009 except two
(forensic and one on behavioral management) for hospital
who use TJC for deemed status
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
CMS says it is not the department in which
the patient is located but the behavior of the
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 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
When Drug is Not a Restraint
 Medication is within pharmacy parameters
set by FDA and manufacturer for use
 Use follows national practice standards
 Used to treat a specific condition based on
patient’s symptoms
 Standard treatment would enable patient to
be effective or appropriate functioning
 Includes these in your P&P
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
 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)
 It is when they are alone in a room and physically
prevented from leaving
 May only use seclusion for management of V/SD
behavior that is danger to patient or others
 Time limits on length of order apply such as four
hours for an adult
 One hour face to face evaluation must be done
 Therapeutic holds to manage V/SD patients are a
form of restraint
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
 Methods that involve the physical holding of
a patient for the purpose of conducting
routine physical examinations or tests (161)
Restraints Do Not Include
 Protecting the patient from falling out of bed
 Cannot use side rails to prevent patient from
getting out of bed if patient can not lower
 Striker beds, narrow gurneys, or the narrow
carts and their use of side rails are not a
 IV board unless tied down or attached to bed
 Postural support devices for positioning or securing
 Device used to position a patient during surgery or
while taking an x-ray
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
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
So, Is This a Restraint?
Restraint Chair Used by Law Enforcement
 Emergency restraint
 Manufacturer states
used for safe
transports to hospital
or court
 Safely restrains a
combative or self
destructive person
 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
 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
 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
Weapons 154
 CMS does not consider the use of weapons by
hospital staff on patients as safe in the
application of restraint (154)
 Could use on criminal breaking into building
 Weapons include pepper spray, mace, nightsticks,
tazers, stun guns, pistols, etc.
 Okay if patient is arrested and use by law
enforcement such as non-employed staff like police
as state and federal laws
 Be sure to share this section with security
 Should do comprehensive assessment and
assess to reduce risk of slipping, tripping or
 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)
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
Reasons to Restrain
(Check all that apply)
 Unable to follow directions
 Aggressive
 Disruptive/combative
 History of hip fracture/falls
 Self injury
 Interference with treatments
 Removal of medical devices
 Other: ____________________________
Rule #4 Less Restrictive
Restraints can only be used when less restrictive
interventions have been determined to be
ineffective to protect the patient or others from
harm (154, 164, 165,)
Type or technique used must also be least
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
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
You must train on what is least restrictive
Least Restrictive Restraint to More
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
Consider Alternatives
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
Alternatives to Restraints
Watching TV
Massage or family can hire massage
Punching bag
Avoid sensory overload
Fish tanks
Tapes of families or friends
Restraints LIP Can Write Orders
Rule #6 LIPs can write orders for restraints
Any individual permitted by both state law
and hospital policy for patients
independently, within the scope of their
licensure, and consistent with granted
privileges, to order restraint, seclusion
 NP, licensed resident, but not a medical student
and CMS said usually not a PA
Remember must specify who in your P&P (168)
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
Hospital P&P should address the definition of asap
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
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)
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
Rule #9 Plan of Care
Restraints must be used in accordance with a
written modification to the patient's plan of care
 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
 Within time frame specified in P&P (166)
 Plan reflects a loop of assessment, intervention,
evaluation and reevaluation
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
 Many states require for behavioral health department
Debriefing no longer mandated by TJC for
behavioral patients (deemed status)but deescalation is in PC.01.01.01
Can add information on debrief to R&S toolkit
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)
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
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
Took out word continually monitored except
for V/SD patients and says at an interval
determined by hospital policy
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
This must be in your hospital P&P frequency of
evaluations and assessments (175) and
document to show compliance
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
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
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)
Document Type of Restraint
Not a Good Documentation Sheet
Log and QAPI
Hospital take actions thru QAPI activities
Hospital leadership should assess and
monitor use to make sure medically
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
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
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
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
Training requirements are detailed and discussed
To rule out possible underlying causes of
contributing factors to the patient’s behavior
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
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
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)
Rule #15 Time Limited Orders
Time limits apply- written order is limited to
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
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,
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
Rule #16 Renew Order
Each order for non violent or non-destructive
patients may be renewed as authorized by
hospital policy (173)
Remember TJC requires an order to renew nonbehavioral health patients) according to your
It could be daily or every 24 or 48 hours
Different from patients who are violent and or self
destructive which is every 24 hours
CMS and TJC the same
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
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)
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
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
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
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
 Consider document in your tool kit although not required by
– Required by TJC in PC.01.01.01
 Teach staff what is de-escalation and not just staff on the
behavioral health unit
 Avoid confrontation and approach in a calm manner
 Active listening
 Valid feelings such as “you sound like you are angry”
 Some have personal de-escalation plan that lists triggers such
as not being listening to, feeling pressured, being touched, loud
noises, being stared at, arguments, people yelling, darkness,
being teased, etc.
Staff Education
The use of non-physical intervention skills
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)
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)
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
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
Training Cost
Individuals doing training program must be
Trainers must have high level of knowledge and
need to document their qualifications
Train the trainer programs are done by many
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
Training Time and Time Spent
National Association of Psychiatric Health Systems
(NAPHS), initial training in de-escalation
techniques, restraint and seclusion policies and
Recommended 7-16 hours of training but number of
hours not mandated by CMS
 Just make sure your staff know the R&S requirements
In fact, in Federal Register recommended sending
one person to CPI training class as a train the
 1
Education Physicians and LIPs
Physician and other LIP training requirements
must be specified in hospital policy (176)
 Consider having physician sign attestation and give them
copy every two years when re-credentialing
At a minimum, physicians and other LIPs authorized
to order R or S by hospital policy in accordance with
State law must have a working knowledge of
hospital policy regarding the use of restraint or
Hospitals have flexibility to determine what other
training physicians and LIPs need
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
Rule #20 1:1 Monitoring R&S 183
For behavioral health patients- which CMS now
calls violent or self destructive behavioral that is a
danger to self or others
Can’t use R&S together unless the patient is
visually monitored in person face to face or by an
audio and video equipment
Person to monitor patient face to face or via audio
& visual must be assigned and a trained staff
 Must be in close proximity to the patient (183)
 There must be documentation of this in the medical record
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
Consider sitter policy to ensure does not
leave patient unsupervised
Rule #21 Deaths
Report any death associated with the use of
restraint or seclusion
Remember, the Safe Medical Devices Act
(SMDA) also requires reporting
Sentinel event reporting to Joint Commission
is voluntary but need to do RCA within 45
See Hospital Reporting of Deaths Related to RS,
OIG Report, September 2006, OEI-09-04-003501
Rule #21 Deaths 0214 2013
The hospital must report to CMS each death that
occurs while a patient is in restraint or in seclusion
at the hospital
Must report every death that occurs within 24 hours
after the patient has been removed from R&S
 Except if patient dies in one or two soft wrist restraints and
the restraints did not cause the death
 Document in MR and complete internal log
Each death known to the hospital that occurs within
1 week after R&S where it is reasonable to assume
that use of restraint or placement in seclusion
contributed directly or indirectly to a patient's death
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
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
Soft Wrist Restraints 2013
 Will need to include information in internal log
 Log must be done asap and never any later than 7 days
 Log must include patient’s name, date of birth, date of
death, attending physician, primary diagnosis, and
medical record number
 Name of practitioner responsible for patient could be used
in lieu of attending if under care on non-physician
 CMS could request to review the log at anytime
 Would still require reporting of deaths within seven
 Need to rewrite policies and procedures and train all staff
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
Next Sections
Medical records services
Medical staff
Pharmacy services
Nursing services
Laboratory services
Visitation 215
Dec 2011
 A hospital must have written P&P regarding the
visitation rights of patient
 Must include any reasonable or clinically
necessary restrictions
 Does not recommend restricting visitation in ICU
 Same day surgery patients may wish to have a
support person present during pre-op and post-op
 An outpatient may wish to have a support person
present during examination by the physician
Visitation 215
 Need written P&P to address patient’s right to have
 Any restrictions must be clinically necessary or
 Can be restricted if interferes with the care of the
patient or others
 Restrictions for child visitors
 Restrictions may include; infection control issue,
court order, disruptive visitor, patient or room mate
needs rest, inpatient substance abuse program,
patient is having a procedure, etc.
Visitation Rights Notice
 Hospital must have written P&P on visitation rights
 Policy includes the restrictions
 Hospital must inform each patient of any restrictions
to visitation and must document it was given
 Inform patient of the right to receive visitors their
choose and they can change their mind
 This includes spouse, same sex partner, friend, or family
 Support person may be the same or different from
the patient representative
 Any refusal to honor must be documented in the chart
Patient Visitation Rights 217
 The hospital policy must ensure that all visitors
enjoy full and equal visitation rights no matter who
they are
 Can not discriminate based on sex, gender, sexual
orientation, race, or disability
 Surveyor will ask patients if visitors restricted
against their wishes and if so was it in the P&P
 Hospital needs to educate the staff
 Consider in orientation and periodically
 Should have a culturally competent training program
Support Person
Adverse Event Reporting
 Hospitals are required to track AE
 Several reports show that nurses and others were
not reporting adverse events and not getting into
the PI system
 OIG recommends using the AHRQ common
formats to help with the tracking
 States could help hospitals improve the reporting
 Encouraged all surveyors to develop an
understanding of this tool
Report Adverse Events to PI
Hospital CoPs for QI
CMS issued new hospital COPs for QA and
Performance Improvement
CMS issues Memo March 15, 2013 on AHRQ
Common Formats
 Hospitals are required to track adverse events for PI
Starts with tag number 0263
Short section because the hospital compare
program is not part of the CMS CoP
 Hospital compare is the indicators that must be sent to
CMS to receive full reimbursement rates
Hospital Common Formats
Hospital CoPs for QAPI
Must have PI program that is ongoing and
shows measurable improvements, that
identifies and reduces medical errors
Diagnostic errors, equipment failures, blood
transfusion injuries, or medication errors
Medical errors may be difficult to detect in hospitals
and are under reported
Make sure incident reports filled out for errors and
near misses
Remember the QAPI Worksheet
CMS Hospital CoPs
Triggers can help hospitals find errors
Trigger tools available on IHI website1
Program must incorporate quality
indicator data including patient data
Look at information submitted to or from
CMS Hospital CoPs QAPI
QIO to advance quality of care for Medicare
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
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
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
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
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
Need adequate resources for PI and patient safety
(315, 316)
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
So what’s in your PI and Safety Plans?
Medical Staff 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 basedlocations, 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
Medical Staff 0340
MS can include other categories of non-physicians
determined to be eligible
 But must follow state scope of practice law such as
dietician, PharmD, NP, or PA
MS must periodically conduct appraisals of its
 MS bylaws determine frequency of appraisals
Recommends at least every 24 months (TJC C&P is
24 months)
To be sure they are suitable for continued membership
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
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
 If limit privileges must follow laws such as reporting to NPDB
 MS bylaws need to identify process for periodic appraisals
Medical Staff 0341 and 342 2013
MS must examine credentials and make
recommendations to the board on appointment of
the candidates and must look at the following
 Request for privileges, evidence of current licensure,
training and professional education, documented
experience, and supporting references of competence
 Can’t make a recommendation based solely on presence
or absence of board certification although can require
board certification
 MS must examine credentials of all eligible to be on the
MS including non-physicians (NP, PA, PharmD etc.)
Telemedicine standards repeated in tag 342 & 343
Medical Staff Organization 347 2013
MS is accountable to Board for quality of medical
care provided
If MS has executive committee, majority of
members must be MD/DO
Responsibility for the MS is assigned to MD, DO,
dentist or podiatrist
 MS must be well organized-formalized organizational
structure and lines are delineated between the MS and the
Board & can have MEC Committee to represent MS
MS must have bylaws and must enforce bylaws and
Board must approve bylaws
Medical Staff
MS must adopt and enforce bylaws (353)
Board must approve bylaws and any changes also
 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)
Medical Staff
Privileges for each category ( eg. active,
courtesy, consulting, referring, emergency
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)
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
Survey procedure-verify bylaws describe who is
responsible for review and evaluation of the clinical
work of MS
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
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
Must be on chart before surgery
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
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
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
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
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
Autopsies 0364
MS should attempt to secure autopsies
in all cases of unusual deaths
Must define mechanism for
documenting permission to perform an
Must be system for notifying MS and
attending doctor when autopsy is
 TJC has similar section
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
 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
Director of Nursing Service
DON must be RN, A-386
 Often referred to as chief nursing officer or CNO
CNO responsible for determining types and
numbers of nursing personnel
CNO responsible for operation of nursing service
Survey procedure-look at organizational chart
May read job description of DON to make sure it
provides for this responsibility
May verify DON approves patient care P&P’s
Nurse Staffing 392
Nursing service must have adequate number
of nurses and personnel to care for patients
 Answer call lights timely and check on patient if cardiac
monitor alarms
Must have nursing supervisor
Every department or unit must have a RN
present (not available if working on two units
at same time)
Survey procedure-look at staffing schedules that
correlate number and acuity of patients
Nurse Staffing 392
There are 3 recent evidenced based studies
that show the importance of having adequate
staffing which results in better outcomes
Study said patients who want to survive their
new hospital visit should look for low nursepatient ratio
Nurse Staffing and Quality of Patient Care, AHRQ,
Evidence Report/Technology Report Number 151,
March 2007, AHRQ Publication No. 07-E0051
Nursing Linked to Safety
IOM study also linked adequate staffing
levels to patient outcomes
Limits to number of hours worked to prevent
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
Nursing Linked to Safety
Also showed medication error rate, falls,
pressure ulcers, UTI, surgery site infections,
gastric ulcers, codes, LOS, increased
unnecessary readmissions, patient
experience or satisfaction rates etc. linked to
 Important in value based purchasing
Redesigning the work force
See Keeping Patients Safe: Transforming the Work
Environment of Nurses 20041
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
Again shows that patient safety and quality is
affected by short staffing
Patient Safety and Quality: An Evidence-Based
Handbook for Nurses, 20081
 1
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
RN for Every Patient 395
A RN must supervise and evaluate the
nursing care for every patient
RN must do admission assessment
Must use acceptable standard of care
Evaluation would include assessing
each patient’s needs, health status and
response to interventions
Nursing Care Plan 396
Hospital must ensure that nursing staff develop and
keeps a current, nursing care plan for each patient
If nursing participates in interdisciplinary care
plan then do not have to have separate nursing
plan of care
Starts upon admission, includes discharge
planning, physiological and psychosocial factors
Based on assessing the patient’s needs
Care plan is part of the patient’s medical records
and must be initiated soon after admission, revised
and implemented
Agency Nurses 398
Agency nurses or traveling nurses (CMS calls
them non-employee nurses) must adhere to
CNO must provide adequate supervision and
evaluate (once a year) activities of agency
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
Preparation/Admin of Drugs 405 2013
Drugs must be prepared and administered according
to state and federal law
 404 deleted and combined with 405
Need an practitioner’s order
 CMS changes to allow other practitioners who are allowed to order to
sign off order such as PharmD as allowed by P&P and state scope of
practice and MS bylaws/RR
Surveyor will observe nurse prepare and pass
Medications must be prepared and administered with
acceptable national standards of practice (TJC MM
chapter), manufacturer’s directions and hospital policy
Changes to Tag 405 Medications 30 Minutes
Changes to 405 June 7, 2013
Administration of Meds 0405
Medication management is a hot topic with
All drugs administered under the supervision
of nursing or other personnel if permitted by
In accordance with approved medical staff
P&P’s, state & federal laws, MS bylaws and
R/R and scope of practice
Surveyor will review sample of medication
records to ensure it conforms to physician’s order
Administration of Meds 405
Need to have an order, make sure compliant
with state and federal laws, and acceptable
standards of practice
Need to have a P&P with three time frames on
timing of medications
Must educate staff and policy must comply with the
10 page memo issued
Include medications not eligible for scheduled
dosing such as stat drugs, PRN, loading doses,
drugs for scheduled procedure etc.
Administration of Meds 405
 Medications that are eligible for scheduled times
 P&P to include time-critical scheduled medications
given in 30 minutes with one hour window
 P&P that are non-time-critical scheduled
 2 hours for medications prescribed more frequently than
daily, but no more frequently than every 4 hours and
 4 hours for medications prescribed for daily or longer
administration intervals
 P&P on missed or late medications
Standing Orders 2013
 This memo had a section on standing orders but in
final IG deleted from 405 and added to 457 but still
helpful to read this memo
 So now in sections 450, 406, and 457
 P&P need to address how standing order is
developed, approved, monitored and initiated by the
 MS must approve along with nursing and pharmacy
 Must include how the practitioner authenticates the
Patient Safety Brief
Nursing Services Standing Orders
 Standing orders are used in codes and by Rapid
Response Teams (RRT)
 Used in the emergency department (ED) for acute
asthma attacks, acute MI, and stroke
 Used in PACU
 Used to increase immunization rates beyond the flu
and pneumovax such as Hepatitis B for at-risk
 Currently there are exceptions for the influenza vaccine
and pneumococcal vaccine
Standing Orders Moved to Tag 457 2013
 Specific clinical situations, diagnosis, and condition
must be appropriate to be a standing order
 P&P must address the education of medical and
nursing staff
 Order must be entered into the medical record
 Any protocols, order sets, preprinted orders or
standing orders must meet these sections
 These must be based on nationally recognized
standards and evidenced-based guidelines and
Physician Order 406 2013
Standard: Drugs and biologicals must be
prepared on the order contained within preprinted
and electronic standing orders, order sets, and
protocols if meet the standards in tag 457
Orders for drugs can be documented and signed
by other practices if acting in scope of practice,
state law, P&P, and MS bylaws and R/R
CMS issues standing order memo 10-24-08
Also includes standing orders, preprinted orders
and use of rubber stamps
Physician Order 406 2013
Flu and pneumovax can be given by protocol
approved by the MS after assessment of
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
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
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
Preprinted Order Sets
Must date and time when the order set is signed
Must indicate on last page the total number of pages in
the order set
If want to strike out something in the order sheet or delete
it or add order on blank line then physician needs to initial
each place
Should add this to the MR audit sheet to make sure there
is compliance with this guideline
Standing orders must address well-defined clinical
scenarios involving medication
Refers to tag 457 and 450 for more information
Verbal Orders 407 and 408
Verbal orders are a patient safety issue
Have lead to many errors
Hospital must describe situations in which they can
be used as well as limitations
Must establish the identity and author of all orders
Rewrite your P&P and Medical staff by-laws to be
consistent with these standards
Repeated VO section in MR starting with tag 454 and
reiterated area of verbal orders offer too much room
for error
Verbal Orders 2013
Must follow state law for time period to sign off
such as 24 or 48 hours
If no state law do not have to sign off in 48 hours
 Must sign off orders within time frame set by
hospital policy
 Many hospitals without a state law can choose
to have signed off in 30 days
 But still try and get them signed off ASAP
 Must still sign name and date and time the order
CMS Verbal Orders 2013
Emphasizes to be used infrequently and never for
convenience of the physicians
This means that physician should not give verbal
orders in nursing station if he or she can write them
Can be used in emergency or if surgeon is scrubbed
in during surgery
Regulation broadens category of practitioners who
can sign orders off such as PA or NP
Renewed any physician can sign off for any other
physician on the case
Verbal Orders P&P Should Include
Limitations or situation on not using VO such
as not for chemotherapy
List the elements for a complete VO (such as
patient name, drug, dose, frequency, name
of person giving and taking order, et al.)
Define who can receive VO and the method
to ensure authentication
Provide guidelines for clear and effective
Signing Off Verbal Orders
Person taking VO must document it in the chart
Physician must sign off a verbal order, date, and
time it when signed off
Any physician on the case can sign off any VO
This practice must be addressed in the hospital’s
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
Verbal Orders
Regulation states that verbal orders should
be authenticated based on state law
Some states require order to be signed off
in 24 hours or 48 hour and if no state law
then no longer a set 48 hours but what your
hospital P&P dictate
Need hospital P&P to reflect these
Write it down and repeat it back
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
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)
Blood Transfusions and IVs 409 2013
CMS issued a memo on 5-20-2011 on what
had to be taught to nurses on IV medications
and blood and blood products
CMS made changes June 7, 2013
Blood transfusions and IV medications must
be administered with state law and MS
bylaws and approved P&P
 Including scope of practice of what a nurse is allowed to
do such as in some states LPN can not hang blood
 Make sure you follow your hospital P&P if training required
Blood Transfusions and IVs 2013
 Is there evidence that staff competent in;
 Maintaining fluid and electrolyte balance
 Venipuncture techniques
 Blood transfusion: blood components,
administration policy, national standards of practice,
patient monitoring requirements including
frequency, documentation, verifying correct blood
and patient
 Transfusion reactions; Identification, treatment and
reporting requirements
Incident Reports Transfusions
There must be procedure for reporting
transfusion reactions, adverse drug reactions
and errors in administration of drugs (410)
Survey procedure - request procedure for reportingthey may review the incident reports or other
documentation through QAPI program
But must have a hospital P&P for reporting
transfusion reactions such as an incident reporting
 See tag number 508 which was updated May 20, 2011 on
this issue
ADE and Drug Administration 410
 Mentions similar standard in pharmacy section
which is in tag 508
 Wants to be all drug errors and ADE are reported
 This includes any blood transfusions AE
 Discusses symptoms of a transfusion reaction
 Need P&P for internal reporting of transfusion
reactions since be life threatening
 Must be immediately reported to the practitioner
responsible for the patient’s care and documented
in the medical record and report to PI
Self Administration of Medication 412 2013
 New tag number in 2013, Tag 412 and 413
Standard: Hospital may allow a patient or
caregiver to self administer both hospital
issued medication and the medication the
patient brought from home
 As specified in the hospital P&P
 Revise your policy to include this section
 Add this to the education of your nursing and
pharmacy staff
Self Administration of Medication 412 2013
Must have an order, must make sure patient
is competent to do, must educate the patient
P&P must address security of medication for
each patient
Must document in the MR so patient must let
nurse know
Visually inspect medication for integrity
Previously this section was in the pharmacy
section 502
CMS Self Administered Drugs 412 and 413
See Tag 412 and 413 March 2013
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
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
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
Retention of Record 438
MR on each patient
Both inpatients and outpatients
MR must be accurate
Contains all orders, test results, care plans, treatment
and response to treatment), complete, retained and
Accessible 24 hours a day
Use a system of author identification and protect
security of all records
Protected from fire, water damage and other threats
Medical Records
Must be promptly completed and within 30
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
 See retention law memo from AHIMA
 Will request records from 48-60 months ago
Retrieval 440
Must have a system of coding and
indexing that allows timely retrieval of
Must be able to retrieve by diagnosis
and procedure to support medical care
MR have to be accessible for
departments that need them like the
emergency department
Privacy & Confidentiality Memo 3-2-12 Tag 147
Privacy & Confidentiality Memo
 Discusses privacy & confidentiality consistent
with HIPAA
 HIPAA 526 pages of changes Sept 23, 2013
 Discusses incidental uses and disclosures
 Allows name on spine of chart
 Allows name on outside of patient room
 Allows signs such as fall risk or diabetic diet
 Will cover later in the presentation
Tag 441 Confidentiality of Medical Records
Tag 442 and 443 Deleted
Confidentiality 441 2013
Standard: Must have a procedure for
ensuring confidentiality of MR
Hospital must ensure that unauthorized individuals
can not gain access to or alter the medical records
Copies may only be released to authorized
individuals and written authorization by
proper person, DPOA, guardian, etc.
Release original only for court orders, subpoenas but
usually will take a certified copy
Surveyor will ask for policy
Confidentiality 441
 Reiterated some of the things in tag 143 and 147
 Must have P&P to ensure confidentiality of the MR
 May use for payment or healthcare operations
without the patient’s authorization
 Financial, legal, PI, activities of the hospital to conduct
business and support core functions, case management,
audit, medical reviews, fraud and abuse detection, etc.
 P&P must limit disclose of MR to the minimum
disclosure necessary
 Surveyor will observe to make sure MR protected
Content of Records A-449
Contain records, notes, reports assessment to
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
Legible and Authenticated 450
All entries must be legible, complete, dated and
Must be authenticated by the person responsible
for ordering, providing, or evaluating the service
Specify in MS or hospital policy who can make entries
in medical record
Need method to identify author
 Written signatures, electronic signature, initials, computer
key, or other code and a list of written signatures must be
Legible and Authenticated
Must have P&P if electronic medical record
If non MD does H&P or document exams, must be
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
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
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
Verbal Orders 454 and 457 2013
 Recall verbal order section starting in NS section at tag
number 407 and 408 is repeated and already discussed
 All doctor can sign VO for any other doctor on case or
practitioner responsible for care if within scope and state law
 Person who takes VO must read it back and write it down
with date and time
 When doctor or LIP authenticates and signs off order must
date and time it also
 Sign off as required by state law and if no state law then as
required by your hospital P&P
 If state law says sign off in 24 or 48 hours you must follow
 If no state law then no longer 48 hours and many hospitals sign off
within 30 days but must still sign off, date and time the entry
Tag 457 Standing Orders 2013
 Standard: hospitals can use preprinted and
electronic standing orders, order sets, and protocols
for patient orders only if the hospital has the
following 4 things:
 Make sure the orders and protocols have been
reviewed and approved by the ME (such as the
MEC) and the hospital’s nursing and pharmacy
 Demonstrate that the orders and protocols are
consistent with nationally recognized and evidenced
based guidelines
Tag 457 Standing Orders 2013
 No standard definition of standing orders
 For brevity CMS uses standing orders to include
pre-printed orders, electronic standing orders, order
sets and protocols
 Said these are forms of standing orders
 States lack of standard definition may result in
 Not all preprinted and electronic order sets are
considered a standing order covered by this
Tag 457 Standing Orders 2013
Example; doctor or qualified practitioner picks
from an order set menu and treatment
choices can not be initiated by nurses or
other non-practitioner staff then menus are
not standing orders covered by this regulation
Menu options does not create an order set
subject to these regulations
The physician has the choice not to use this
menu and could create orders from scratch or
modify it
Standing Order Requirements
 Must be well-defined clinical situations with
evidence to support standardized treatments
 Appropriate use can contribute to patient safety
and quality care
 Can be initiated as emergency response
 Can be initiated as part of an evidenced based
treatment regime where not practicable to get a
written or verbal order
 Must be medically appropriate such as RRT
Standing Order Requirements 457
 Triage and initialing screening to stabilize ED
patients presenting with symptoms of MI, stroke,
 Post-operative recovery areas like PACU
 Timely provisions of immunizations
 Can’t be used when prohibited by state or federal
law so no standing orders on R&S
 CMS has set forth a number of minimum
requirements for standing orders that must be
present for a well-defined clinical scenario
Minimum Requirements for Standing Orders
 Must be approved by MS, nursing and pharmacy
 P&P address how it is developed, approved,
monitored, initiated by staff and signed off or
 Must have specific criteria identified in the protocol
for the order for a nurse or other staff to initiate
 Such as a specific clinical situation, patient condition or
 Must include process to have them signed off
Minimum Requirements for Standing Orders
 Hospital must document standing order is
consistent with nationally recognized and evidenced
based guidelines
 Burden is on the hospital to show there is sound
basis for the standing order
 Must have regular review to ensure its still useful
and a safe order
 P&P address how to correct it, revise or modify
 Must be placed in the order section of the chart
 Must be dated, timed, and signed
Tag 457 Standing Orders 2013
 Make sure there is periodic and regular review of
the orders and protocols conducted by the MS,
nursing and pharmacy leadership to determine the
continued usefulness and safety
 Make sure they are dated, timed, and
authenticated promptly in the medical record
 Signed off by the ordering practitioner of another
practitioner on the case
 Could be signed off by non-physician if allowed by
hospital policy, state law, the person state law scope
of practice, and MS bylaws or R/R
History and Physical 458 and 461 2013
Repeats same provisions on H&P as in
medical staff section under tag number 358
and 359
H&P done within 24 hours, not older than 30
days old and updated within 24 hours and
updated and on chart before patient goes to
PA and NP can do if allowed by hospital and all
state laws allow and physician reviews and
authenticates with date, time, and signature
MR Must Contain 464 and 465 2013
Must have admitting diagnosis in chart (463)
All consults and findings by clinical staff and others
must be documented (464)
Information must be promptly filed in the MR so staff
has access to it (464)
Must document complications and healthcareassociated infections (HAI) and unfavorable
reactions to drugs and anesthesia (465)
It is important for all practitioners to be aware of the
need to document complications and how to do this
Informed Consent 466
Now three separate sections related to informed
consent in patient rights, medical record and
surgical services
Properly executed informed consent for
procedures and treatments specified by MS
Need list of all surgeries
As defined now by ACS and AMA
Listed procedures with yes or no
Informed Consent MR Mandatory
Minimum elements in an informed consent
Name of hospital
Name of procedure or treatment
Name of responsible practitioner who is
Statement that benefits, material risks and
alternatives were explained
Signature of patient
Date and time form is signed
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
Consider List of Procedures
Procedure Name
Requires Informed Consent
Arterial Line insertion (performed alone) Yes
Aspiration Cyst (simple/minor)
Consider List of Procedures
Procedure Name
Requires Informed Consent
Aspiration Cyst (complex)
Blood Administration
Blood Patch
Bone Marrow Aspiration
Bone Marrow Biopsy
Capsule Endoscopy
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)
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
Well Designed (Optional)
Name of the practitioner who conducted the
informed consent discussion with the patient
or the patient’s representative
It is required to tell the patient this but
optional to put it in writing
Date, time, and signature of witness
Indication or listing of the material risks of the
procedure or treatment that were discussed with
the patient or the patient’s representative
Well Designed (Optional)
Statement, if applicable, that physicians other
than the operating practitioner, including but not
limited to residents, will be performing important
tasks related to the surgery, in accordance with
the hospital’s policies and, in the case of
residents, based on their skill set and under the
supervision of the responsible practitioner
Still have to inform patient if someone is doing
important parts of the surgery but having it in
writing is optional
Well Designed (Optional)
Statement, if applicable, that QMP who are
not physicians who will perform important
parts of the surgery
or administration of anesthesia will be
performing only tasks that are within their
scope of practice,
 as determined under State law and
 and for which they have been granted
privileges by the hospital
Survey Procedure
Verify hospital has assured MS has list of
procedures and treatments that require
Verify informed consent forms six mandatory
Compare the hospital standard informed
consent form to the P&Ps to make sure
Make sure any state law requirements are
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
Any other information used to monitor the
patient’s condition
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
Final Diagnosis 469
Every medical record has to have a final
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
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
Pharmacy 490
Provide medication related information to
hospital personnel
Medication Management is important to CMS
and TJC and TJC has a medication
management chapter
Contains list of functions of the pharmacist
Collect patient specific information, monitor
effects, identify goals, implement monitoring plan
with patient,
Flag new types of mistakes
Pharmacy Policies Include:
High alert medication-dosing limits-packaging,
labeling and storage (policy at 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
Pharmacy Policies
Avoid dangerous abbreviations
All elements of order; dose, strength, route, units,
rate, frequency
Alert system for sound alike/look alike (LASA)
Use of facility approved pre-printed order sheets
whenever possible
“Resume pre-op orders” is prohibited
Voluntary, non-punitive reporting system to monitor
and report adverse drug events
Pharmacy Policies
Preparation, distribution, administration and
disposal of hazardous medications (chemotherapy)
 Drug recall
Patient specific information that should be readily
 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
Pharmacy Policies 490
Identification of weight based dosing for
pediatric populations
Requirements for review based on facility
generated reports of adverse drug events
and PI activities
Policy to identify potential and actual adverse
drug events (IHI trigger tool, concurrent
review, observe med passes etc.)
Must periodically review all P&P’s
Pharmacy Policies Include
Need a multidisciplinary committee committee of medicine, nursing,
administration, and pharmacy to develop
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
Pharmacy Management 491
Pharmacy or drug storage must be administered
in accordance with professional principles (TJC
03.01.01 and problematic standard)
This includes compliance with state laws
(pharmacy laws), and federal regulations (USP
797), standards by nationally recognized
organizations (ASHP, FDA, NIH, USP, ISMP,
Pharmacy director must review P&P periodically
and revise
Pharmacy Management 491
Drugs stored as per manufacture’s
instructions; refrigerate, freeze, room
temperature, keep out of light etc.
Pharmacy employees provide services
within the scope of their licensure and
Sufficient pharmacy records to follow flow
from order to dispensing/administration
Maintain control over floor stock
Pharmacist 491
Ensure drugs are dispensed only by
licensed pharmacist
Must have pharmacist to develop,
supervise, and coordinate activities of
Can be part time, full time or consulting
Single pharmacist must be responsible
for overall administration of pharmacy
Pharmacist 491
Job description should define development,
supervision, and coordination of all activities
Must be knowledgeable about hospital
pharmacy practice and management
Must have adequate number of personnel to
ensure quality pharmacy service, including
emergency services
Sufficient to provide services for 24 hours, 7
days a week
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
Delivery of Service 500
Pharmacist and hospital staff and committee
develop guidelines and P&P to ensure control and
distribution of medications and medication devices
System in place to minimize high alert medication
(double checks, dose limits, pre-printed orders,
double checks, special packaging,
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
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
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
Delivery of Service 500
 Policy to address use of medications brought in
 P&P to ensure investigational meds are safely controlled and
 Medications dispensed are retrieved when recalled or
discontinued by manufacturer or FDA (eg. Darvocet N)
 System in place to reconcile medication that are not
administered and that remain in medication drawer when
pharmacy restocks
 Will ask why it was not used?
 Not the same as medication reconciliation as in the TJC
NPSG which all hospitals should still do from a patient safety
perspective although in worksheets mentions this
Compounding of Drugs 501
All compounding, packaging, and disposal of
drugs and biologicals must be under the
supervision of pharmacist
Must be performed as required by state of federal
law & compounding law passed in 2013
Staff ensure accuracy in medication
Staff uses appropriate technique to avoid
Compounding of Drugs
Use a laminar airflow hood to prepare any IV
admixture, any sterile product made from non-sterile
ingredients, or sterile product that will not be used
within 24 hours (see USP 797)
Meds should be dispensed in safe manner and to
meet the needs of the patient
Quantities are minimized to avoid diversion,
dispensed timely, and if feasible in unit dose
All concerns, issues, or questions are clarified
with the individual prescriber before dispensing
Locked Storage Areas 502
Drugs and biologicals must be kept in a
secure and locked area
Would be considered a secure area if staff
actively providing care but not on a weekend
when no one is around
Schedule II, III, IV, and V must be kept locked
within a secure area (see also 503)
Only authorized person can get access to
locked areas
Locked Storage Areas 502
Persons without legal access to drugs and
biologicals can have not have unmonitored access
They can not have keys to storage rooms, carts,
cabinets or containers with unsecured medications
(housekeeping, maintenance, security)
Critical care and L&D area staffed and actively
providing care are considered secure
Setting up for patients on OR is considered secure
such as the anesthesia carts but after case or when
OR is closed need to lock cart
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
Securing Medications
CMS made changes in the FR effective June 2013 to
match the interpretive guidelines (See 412 & 413)
May allow patients to have access to urgently needed
drugs such as Nitro and inhalers
Need P&P on competence of patient, patient education
and must meet elements in TJC MM standard on self
Measures to secure bedside medications
Document when patient reports the medication was
Inspect the integrity of the medication
Locked Storage Areas
Saline flushes need to be secure to prevent
tampering so under constant supervision or locked
up (FDA does not consider as medication now)
 Consider having safe injection practices P&P and follow
CDC 10 guidelines such as one needle, one syringe
If medication cart is in use and unlocked, then
someone with legal access must be close by and
directing monitoring the cart, like when the nurse is
passing meds
Need policy for safeguarding, transferring and
availability of keys
Policy and Procedure
CMS states that they expect hospital P&P to
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
TJC Self Administered Meds
Self administered medications are safely and
accurately administered
If you allow self administration, need
procedure to manage, train, supervise, and
document process
TJC MM stands for medication management
standard MM 5.20 or MM.06.01.03
CMS mentions this standard in the FR when
changes were made and said to follow
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
Patient has to be determined to be
competent before allowed to self administer
Mentioned TJC in Federal Register but not
in IG
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.
No Pharmacist on Duty 506
If no pharmacist on duty, drugs removed from
storage area are allowed only by personnel
designated in policies of MS and pharmacy
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
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
Pharmacist reviews all medications removed and
correlates with order first thing in the morning
Medications Errors 508 5-20-11
Drug errors, adverse drug reaction, and drug
incompatibilities must be immediately reported to
the attending physician and to the hospital PI
Definition of med error or ADE should be broad
enough to include NEAR MISSES
Recommend use of the broad definition by National
coordinating council medication error reporting and
prevention definition and ASHP definition of ADR
 Will make sure definition is based on national standards
Must have a P&P for reporting
Medications Errors 508 2013
 Must be documented in the medical record and
reported to QAPI program
 CMS encourages non-punitive approach
 Hospital can not just rely on incident reports but
must take step to identify these events
 Need to measure the effectiveness of systems to
identify and report to the PI program which includes
benchmarks and RCA when indicated
 Encouraged to externally report to FDA MedWatch
program, ISMP medication error reporting program
Medications Errors 509
Hospital must proactively identify med errors
and ADE and can not rely solely on incident
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
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
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
Staff development programs on new drugs
added to the formulary and how to resolve drug
therapy problems
Formulary 511
Formulary system must be established by the MS to
ensure quality pharmaceuticals at reasonable cost
Formulary lists the drugs that are available
Processes to monitor patient responses to newly
added medication
Process to approve and procure meds not on the
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
Next Sections
 Radiology, Dietary
 Utilization review
 Infection Control
 Discharge Planning
 Organ and Tissue
 Surgery and Anesthesia
 Nuclear Medicine
 Emergency Services
 Respiratory
 Rehab
Radiology 529
 Hospital has radiology services to meet
needs of patients
 Radiology services should be provided in
accordance with accepted standards of
 Radiology, especially ionizing procedures,
must be free from hazards for patients and
 Must have policy that provides for safety of both
 Proper safety precautions maintained against
radiology hazards (535)
 Including shielding for patients and personnel as
well as storage, use, and disposal of radioactive
materials (536)
 Need order of practitioner with privileges or
practitioners outside the hospital who have been
authorized by MS to order as allowed by state law
 Period inspection of equipment and fix any hazard
 Check radiation workers by use of badge tests or
exposure meters (538)
Personnel 545
 Qualified radiologist must supervise ionizing
radiology services (546)
 Must interpret those tests that are
determined by the MS to require a
radiologist’s specialized knowledge
 Written policy approved by MS to designate
which tests require interpretation by
 If telemedicine is used, radiologist interpreting must
be licensed and meet state law requirements (state
medical board requirements), (546, see Tag 23)
Personnel 546
 Supervision of radiology by radiologist who is
member of the MS, Supervision should include the
 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
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
 Only qualified personnel may use radiology
 Surveyor will review personnel folders to make
sure they are qualified as established by the MS
for the tasks they perform
Radiology Records
 Radiology records must be maintained for all procedures
performed (553)
 Must contain copies of all reports and printouts and any films,
scans, or other image records
 Must have written P&P that ensure the integrity of
authentication and protect privacy of radiology records - must
be secure and retrievable for five years (555)
 Radiologist or other practitioner who performs radiology
services must sign the report of his or her interpretation
 They have to be signed by the one who read and evaluated
the x-ray (not the partner who is reviewing the dictated report ),
Laboratory Services 576
 Must have adequate lab services to meet the
needs of the patient
 All lab services must in any hospital
department has to meet these guidelines
 All services must be provided in accordance
with CLIA requirements (Clinical Laboratory
Improvement Act) and have CLIA certificate
 Can provide lab services directly or as
contracted service
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
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
Tissue Specimens 584
 Written instructions for the collection,
preservation, transportation, receipts, and
reporting of tissue specimen results
 MS and pathologist determine when tissue
specimens need macroscopic (gross) and
microscopic examination
 Need written policy on this
 TJC has a chapter on transplant safety and FAQs
Blood Banks 592
 Potentially infectious blood and blood
 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
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)
Blood Banks 592
 Time depends on if tested positive on this unit or
tested negative but on later donation tested positive
 Within 3 calendar days if blood tested is positive
 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)
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
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
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
 Enough written or oral information so can make an
informed decision
 List of programs where can get counseled and
 If minor or incompetent or deceased then notify legal
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
Dietary A-618
 Availability of diet manual and therapeutic
diet menus
 Frequency of meals served
 System for diet ordering and patient tray
 Accommodation of non-routine occurrences
(parenteral nutrition (tube feeding), TPN,
peripheral parenteral nutrition, early/late
trays, nutritional supplements
Dietary 618
Integration of food and dietetic services
into hospital wide QAPI and infection
control programs
Guidelines on acceptable hygiene
practices of personnel and kitchen
Compliance with state or federal laws
Organization 620
 Must have full time director who is responsible
for daily management of dietary services
 Must be granted authority and delegation by the
Board and MS for the operation of dietary
 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
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
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
 Collaborate with other services (MS, nursing,
pharmacy, social work)
 Maintain data to recommend, prescribe therapeutic
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
Nutritional Assessment 628
 TJC requires to be done within 24 hours
 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)
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
Nutritional Needs 630
 Must be met in accordance with recognized dietary
 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 2010”1
 Surveyor will ask hospital what national standard
you are using
Utilization Review 652
 Hospital must have a UR plan that provides for
review of services furnished by the institution and
the members of the MS to Medicare and Medicaid
 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
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
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
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
Scope of Reviews 655
 Reviews may be on a sample basis except
for reviews of cases assumed to outlier
cases because of extended stay cases or
high costs
 Surveyor will examine UR plan to determine
if medical necessity is reviewed for
admission, duration of stay and services
 If IPPS hospital there should be a review of the
duration of stay in cases assumed to be outlier
Admissions or Continued Stay
 Determination that admission or continued
stay is not medically necessary is made by
one member of UR committee if MD concurs
with determination of fails to present their
views when afforded the opportunity
 Must be made by two members in all other
cases (656)
 Remember 2 midnight rule and importance of
order and documentation
 Physician certification
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
Admissions or Continued Stay
 If attending doctor does not respond or contest
the findings of the committee, the findings are
 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
Physical Environment 700
Hospital must be constructed, arranged,
and maintained to ensure the safety of
And to provide diagnosis and treatment
and for services appropriate for the
This CoP applies to all locations of the
hospital, all campuses, all satellites
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
 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
Buildings 701
 Condition of physical plant and overall
hospital environment must be developed and
maintained for the safety and well being of
 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
Buildings 701
 Includes developing and implementing emergency
preparedness plans and capabilities
 Must coordinate with federal, state, and local
emergency preparedness and health
authority (dept of health)
 To identify risks for their area (natural disasters,
bio-terrorism threats, disruption of utilities like
water, sewer, electrical, communication, fuel,
nuclear accident)
 Lists 14 things to consider in developing this
 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
Trash 713
 Proper storage and disposal of trash
 Trash includes bio-hazardous waste
 Storage of trash must be in accordance with
state and federal law (EPA, CDC, OSHA,
state environmental health and safety
 Need policies for storage and disposal of
 H2E program - no fee (waste reduction, mercury, et
Fire Control Plan 715
 Need fire control plan
 Must contain section on prompt reporting of
fires, extinguishing fires, protection of
patients and guests, evacuation and
cooperation with fire fighting authorities
 Surveyor will review fire plan
 Verify all fires are reported to state officials
 Will interview staff to make sure they know what to
do during a fire
 Amended for alcohol based hand dispensers
 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
 Make sure water acceptable for its intended
use - drinking, lab water, irrigation - review
water quality monitoring
Ventilation, Light, Temperature 2014
 There must be proper ventilation, light, and
temperature controls in pharmacy, food
preparation and other appropriate areas
 Proper ventilation in areas using ethylene
oxide, nitrous oxide, xylene, pentamidine,
guteraldehydes, or other hazardous
 Temperature controls in pharmacy and food
Ventilation, Light, Temperature 2014
 Ventilation where O2 is transferred from one
container to another
 In isolation rooms and lab locations
 Adequate lighting in patient rooms and food
and medication preparation areas (shown to
reduce medication errors)
 Anesthetizing locations where nonflammable
inhalation anesthetic agents are used
 Will review temp monitoring records
Ventilation, Light, Temperature
 Temperature, humidity, and airflow in OR
within acceptable standards to inhibit
microbial growth
 Remember 2013 humidity memo & 2014 changes with
humidity 20-60% and when waiver is needed
 Each OR room should have a separate temperature
control - have temp and humidity tracking logs
 Incorporate AORN – American Association of
Perioperative Registered Nurses should be
incorporated into hospital policy along with Facilities
Guidelines Institute (FGI)
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
Insulin Pens
CMS Memo on Insulin Pens
 Regurgitation of blood into the insulin cartridge after
injection can occur creating a risk if used on more
than one patient
 Hospital needs to have a policy and procedure
 Staff should be educated regarding the safe use of
insulin pens
 More than 2,000 patients were notified in 2011
because an insulin pen was used on more than one
 CDC issues reminder on same and has free flier
CDC Reminder on Insulin Pens
CDC Has Flier for Hospitals on Insulin Pens
VA Alert on Insulin Pens
 Pharmacist found several insulin pens not labeled
for individual use
 Found used multi-dose pen injectors used on
multiple patients instead of one patient use
 New requirement that can only be stored in
pharmacy and never ward stocked
 Instituted new education for staff on use
 Part of annual competency of staff
 Instituted new policy of safe use of pen injectors
VA Issues Alert in 2013
VA Alert on Insulin Pens
 Decided to prohibit multi-dose insulin pen injectors
on all patient units except the following:
 Patients being educated prior to discharge to use a
insulin pen injector
 Eligible patient is self medication program
 Patient needing treatment and no alternative
formulation is available
 Patients participating in a research protocol requiring
an insulin pen
 Pen injectors dispensed directly to patients as an
outpatient prescription
FDA Issues An Alert in 2009
Insulin Pen Posters and Brochures Available
CMS Memo on Safe Injection Practices
 All entries into a SDV for purposes of repackaging
must be completed with 6 hours of the initial
puncture in pharmacy following USP guidelines
 Only exception of when SDV can be used on
multiple patients
 Otherwise using a single dose vial on multiple
patients is a violation of CDC standards
 CMS will cite hospital under the hospital CoP
infection control standards since must provide
sanitary environment
 Also includes ASCs, hospice, LTC, home health, CAH, dialysis, etc.
Single Dose June 15, 2012
CMS Memo on Safe Injection Practices
 Bottom line is you can not use a single dose vial on
multiple patients
 CMS requires hospitals to follow nationally
recognized standards of care like the CDC
 SDV typically lack an antimicrobial preservative
 Once the vial is entered the contents can support
the growth of microorganisms
 The vials must have a beyond use date (BUD) and
storage conditions on the label
CMS Memo on Safe Injection Practices
 Make sure pharmacist has a copy of this memo
 If medication is repackaged under an arrangement
with an off site vendor or compounding facility ask
for evidence they have adhered to 797 standards
 ASHP Foundation has a tool for assessing
contractors who provide sterile products
 Go to
 Click on starting using sterile products outsourcing tool
Safe Injection Practices
Infection Control 2013
 TJC has chapter on Infection Prevention and
 APIC and CMS now calls infection preventionists
 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
Infection Control (IC)
 Standards apply to all departments of
hospitals both on and off campus
 Infection prevention must include monitoring
of housekeeping and maintenance including
construction activities
 Areas to monitor include food storage preparation,
serving and dish rooms, refrigerators, ice machines,
air handlers, autoclave rooms, venting systems,
inpatient rooms, supply storage and equipment
Infection Control (IC) 747
 Must all standards of care and practice (APIC
(Association for Professionals in Infection Control
and Epidemiology), CDC, SHEA (Society for
Healthcare Epidemiology of America), OSHA, etc.
 Need to investigate infections and communicable
diseases for inpatients and from personnel working
in hospitals including volunteers
 Must have active surveillance program that includes
specific measures for infection detection, data
collection, analysis monitoring, and evaluations of
preventive interventions
CMS Memo on Insulin Pens
 CMS issues memo on insulin pens on May 18, 2012
 Insulin pens are intended to be used on one patient
 CMS notes that some healthcare providers are not
aware of this
 Insulin pens were used on more than one patient
which is like sharing needles
 Every patient must have their own insulin pen
 Insulin pens must be marked with the patient’s
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
and CaUTIs to NHSN
IC Officer’s Responsibilities
Many have added these to their job
 Maintain sanitary hospital environment
(ventilation and water controls, construction make sure safe environment, safe air handling
in areas of special ventilations such as the OR
and isolation rooms, techniques for food
sanitation, cleaning and disinfecting surfaces,
carpeting and furniture, how is pest control
done, and disposal of trash along with nonregulated waste)
IC Officer’s Responsibilities 2013
 Develop and implement IC measures
(hospital staff, contract workers, volunteers)
 Mitigation of risks associated with patient
infections present upon admission and risks
contributing to HAI
 Active surveillance
 Hospital must identify and track the following categories
 HAI selected by IC program targeted strategies based on
national guidelines and periodic risk assessments
 Patients or staff with reportable communicable diseases
IC Officer’s Responsibilities 2013
 Active surveillance (continued)
 Culture or patient colonized with MDRO
 Isolation patients
 Staff or patients with signs in which local, state, or
feds request
 Staff or patients infected with significant pathogens
 Recommend use of automated surveillance
technology (blue box advisory) or data mining
 Monitoring compliance with all P&Ps, protocols and
other infection control program requirements
IC Officer’s Responsibilities
 Program evaluation and revision of the program,
when indicated
 Coordination as required by law with federal, state,
and local emergency preparedness and health
authorities to address communicable disease
threats, bioterrorism and outbreaks
 Complying with the reportable disease
requirements of the local health authority
 Make sure IC program is integrated into hospital
wide QAPI (now stands for quality assessment and
performance improvement)
Infection Control (IC) 749
 Long list of IC policies that hospitals must
 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)
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.
Immediate Use Sterilization
Medical Equipment and Supplies Resources
 Multi-Society Guidelines for Reprocessing
Flexible Gastrointestinal Endoscopes by APIC at
 Disinfection of Healthcare Equipment Chapter in
Guidelines for Disinfection and Sterilization in
Healthcare Facilities Nov 2008 at
 Single Use Device Reprocessing at
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
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
 There must be active surveillance system, method
for getting data to determine if there is a problem
 Policy on getting cultures from patients, etc.
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
Log of Incidents 750
7-16-2012 Deleted
 Must NO longer maintain a log related to infections
and communicable diseases, including HAI
 Use to require a log and it had to include information
from patients and staff so need information from
employee health nurse
 Included employees, contract staff such as agency
nurses, and volunteers
 Included surgical site infections, patients or staff with
MDRO, patients who meet isolation requirements
 Log use to be either a paper or electronic log, TJC
IC.01.01.01 requirement but will change to CMS
CEO, CNO, and MS 756
 The CEO, DON, and MS must ensure that
there is hospital wide QAPI and training
program that address problems identified by
IC officer
 And implement a successful corrective action
plan in affected problem areas
 Train staff in problems identified
 Problems must be reported to nursing, MS,
and administration
Discharge Planning
 CMS issues 39 page memo on May 17, 2013
 Revises discharge planning standards
 Includes advisory practices (blue boxes) to promote
better patient outcomes
 Only suggestions and will not cite hospitals
 The discharge planning CoPs have been
 A number of tags were eliminated
 The prior 24 standards have been consolidated into 13
Discharge Planning Revisions
Transmittal July 19, 2013
Discharge Planning
 The hospital must have a discharge planning (DP)
process that applies to all patients (799)
 To determine if will need post hospital services like home
health, LTC, assisted living, hospice etc.
 To determine what patient will need for safe transition to
 Need to incorporate new research on care transitions
 Hospital needs adequate resources to prevent readmissions
 1 in 5 patients readmitted within 30 days (20%)
 1 in 3 patients readmitted within 60 days (34%)
 The hospital must have written DP P&Ps (799)
Discharge Planning (DP)
 CMS later says DP applies to inpatients only
 However, recommends an abbreviated DP for certain
categories of outpatients such as observation, ED, and
same day surgery
 DP based on 4 stage DP process
 Screen all patients to determine if patient at risk such as
screening questions by nursing admission assessment
 Evaluate post-discharge needs of patients
 Develop DP if indicated by the evaluation or requested by
patient or physician
 Initiate discharge plan prior to discharge of inpatient
Discharge Planning
 Suggest input from MS, board, HH, LTC and others
regarding the DP P&Ps
 Involve patient in the development of the plan of
care (799)
 Standard: The hospital must identify at an early
stage those all patients who are likely to suffer
adverse consequences if no DP is done (800)
 Recommend all inpatients have a DP
 If not must document criteria and screening process used
to identify who is likely to need DP
 No national tool to do this
Discharge Planning
 Must do at least 48 hours in advance of discharge
 If patient’s stay is less than 48 hours then must make sure
DP is done before patient’s discharge
 Must make sure no evidence that patient’s
discharge was delayed due to hospital’s failure to
do DP (800)
 DP P&Ps must state how staff will become aware of
any changes in the patient’s condition (800)
 If patient is transferred must still include information
on post hospital needs (800)
Discharge Planning
 CMS instructs the surveyors to conduct discharge
tracers on open and closed inpatient records
 Standard: The hospital must provide a DP evaluation
to patients at risk, or requested by the patient or
doctor (806)
 Must include the likelihood of needing post hospital services like
home health, hospice, RT, rehab, nutritional consult, dialysis,
supplies, meals on wheels, transport, housekeeping, or LTC
 Is the patient going to need any special equipment (walker, BS
commode, etc.) or modifications to the home
 Must include an assessment if the patient can do self
care or others can do the care
Discharge Planning
 Must evaluate if patient can return to their home
 If from a LTC, hospice, assisted living then is the
patient able to return (806)
 Hospitals are expected to have knowledge of
capabilities of the LTC and Medicaid homes and
services provided (806)
 May need to coordinate with insurers and Medicaid
 Discuss ability to pay out of pocket expenses
 Expected to have know about community resources
 Such as Aging and Disability Resources or Center for Independent
CMS DP Checklist for Patients
Discharge Planning
 Standard: A RN, SW, or other appropriately
qualified person must develop or supervise the
development of the DP evaluation (807)
 Written P&P must say who is qualified
 Standard: the DP evaluation must be completed
timely to avoid unnecessary delays (810)
 Standard: The hospital must discuss the results of
the DP evaluation with the patient (811)
 Standard: The DP evaluation must be in the
medical record (812)
Discharge Planning
 Standard” RN, SW, or other qualified person
must develop the discharge plan if the DP
evaluation indicates it is needed (818)
 DP is part of the plan of care
 Standard: The physician may request a DP if
hospital does not determine it is needed (819)
 Standard: The hospital must implement the DP plan
 Standard: The hospital must reassess the discharge
plan if factors affect the plan (821)
Discharge Planning
 Standard: If patient needs HH or LTC must provide
patients a list (823)
 Standard: Hospital must transfer or refer patients to
the appropriate facility or agency for follow up care
 Standard: the hospital must reassess it DP process
on an on-going basis and review the discharge
plans to ensure they meet the patient’s needs (843)
 Must track readmissions
 Must review P&P to make sure DP is ongoing on at least
a quarterly basis
Organ, Tissue, and Eye 884
 Hospital must have written P&P to address its organ
 Must have agreement with OPO
 Must timely notify OPO if death is imminent or
patient has died
 OPO to determine medical suitability for organ
 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
OPO Agreements with Hospitals
 CMS has a section in the hospital CoP on OPO or
the organ procurement organizations
 Hospitals must have a written agreement with the
 Must do the one call rule and notify the OPO if
patient dies or death is imminent
 OPOs are not required to have an agreement with
a hospital that does not have an OR or a ventilator
 OPO have to contract with hospitals that request it
but limited to notification if no ventilator or OR
OPPO Agreements with Hospitals
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
 Check off the long list to ensure all elements
are present
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
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
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
 Surveyor will review complaint file for relevant
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
 Train all new employees, when change in
P&P, and when problems identified in QAPI
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
 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
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
Surgical Services 940
 If provide surgical services, service must be well
 If outpatient surgery, must be consistent in quality
with inpatient care
 Must follow acceptable standards of practice, AMA,
 Must be integrated into hospital wide QAPI
 Will inspect all OR rooms
 Access to OR and PACU must be limited to
authorized personnel
CMS Memo April 19, 2013
 CMS issues memo related to the relative humidity
 AORN use to say temperature maintained between
68-73 degrees and humidity between 30-60% in
OR, PACU, cath lab, endoscopy rooms and
instrument processing areas
 CMS says if no state law can write policy or
procedure or process to implement the waiver
 Waiver allows RH between 20-60%
 In anesthetizing locations- see definition in memo
Humidity in Anesthetizing Areas
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
 And it is monitored, inspected and maintained by
biomed program
 Temperature and humidity controlled
 ACS and AORN have P&P on many of these
Surgery 942
 OR must be supervised by experienced RN or
 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
Surgical Privileges
 Surgical privileges must be delineated for all
practitioners performing surgery, in
accordance with competence of each
 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
Surgical Privileges
 MS bylaws must have criteria for determining
 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
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
Surgery Policies 951
 Aseptic and sterile surveillance and practice,
including scrub technique
 Identify infected and non-infected cases
 Housekeeping requirements/procedures
 Patient care requirements
 pre-op work area
 patient consents and releases
 safety practices
 patient identification process and clinical procedures
Surgery Policies 951
 Duties of scrub and circulating nurses
 Safety practices
 Surgical counts
 Scheduling of patients for surgery
 Personnel policies in OR
 Resuscitative techniques
 DNR status
 Care of surgical specimens
Surgery Policies A-0951
 Malignant hyperthermia
 Protocols for all surgical procedures
 Sterilization and disinfection procedures
 Acceptable OR attire
 Handling infectious and biomedical
 Outpatient surgery post op planning
Preventing OR Fires 951
Read detailed section on use of alcohol
based skin prep and how to prevent an OR
 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
 Pa Patient Safety Authority has great
H&P 952
See prior sections on H&P
H&P must be on the chart before the
patient goes to surgery
Except in emergencies
P&P specify what is an emergency
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
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
Informed Consent Policy
When is surgery an emergency
Content of consent form
Process to obtain consent
If consent obtained outside hospital
how to get it into medical records
Make sure it is on the chart before the
patient goes to surgery
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
Surgery Equipment 956
 Call-in system
 Cardiac monitor
 Defibrillator
 Aspirator (suction equipment)
 Trach set (cricothyroidotomy is not a
 TJC PC.03.01.01 includes this plus
ventilator, and manual breathing bags
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 assessment includes level of activity,
respiration, BP, LOC, patient color (Aldrete)
 Follow ASPAN standards
OR Register 958
 Patient’s name, id number
 Date of surgery
 Total time of surgery
 Name of surgeons, nursing personnel,
anesthesiologist, and assistants
 Type of anesthesia
 Operative findings, pre-op and post-op diagnosis
 Age of patient
 See TJC RC.02.01.03 which are now the same
Operative Report 959
Name and identity of patient
Date and time of surgery
Name of surgeons, assistants
Pre-op and post-op diagnosis
Name of procedure
Type of anesthesia
Operative Report 959
Complications and description of
techniques and tissue removed
Grafts, tissue, devises implanted
Name and description of significant
surgical tasks done by others (see
list-opening, closing, harvesting grafts
Anesthesia A-1000
 Must be provided in well organized manner under qualified
 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
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
Epidural or Spinal in OB
 The administration of a regional (epidural or spinal)
for the purpose of analgesia during labor and
 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
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
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
 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
Anesthesia Services
 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
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.
Anesthesia Services 1000
 There is no bright line between anesthesia and
 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.
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
 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
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
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
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)
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
1 List of 16 state exemptions at Iowa, Nebraska, Idaho, Minnesota,
New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, South Dakota, Wisconsin, Montana,
Colorado, and California.
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
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)
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
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
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
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
Intra-operative Anesthesia Record 1004
Need policies related to the intra-operative
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
Intra-operative Anesthesia Record
 Intra-operative Record must contain the following
 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
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
 P&Ps must be approved by the MS
 P&Ps must reflect current standards of care
Post Anesthesia Evaluation 1005
 Document in chart within 48 hours for patients
receiving anesthesia services (general, regional,
 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
 Does not have to be done by the same person who
administered the anesthesia
Post Anesthesia Evaluation
 Has to be done only by anesthesia person
(CRNA, AA, anesthesiologist) or qualified
 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.
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
 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
Post-Anesthesia Assessment 1005
 Respiratory function with respiratory rate, airway
patency and oxygen saturation
 CV function including pulse rate and BP
 Mental status,
 Temperature
 Pain
 Nausea and vomiting
 Post-operative hydration
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
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
 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
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
 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!)
Nuclear Medicine 1026
Services must meet needs of patients
Optional service
Radioactive material must be prepared,
labeled, uses, transported, stored and
disposed of in accordance with
acceptable standards of practice
 Will not discuss but be sure to provide to
your director if you do nuclear medicine
Nuclear Medicine
 Hospital must have written safety standards for
radioactive material
 Handling of equipment and material
 Protection of patients and staff from radiation
 Labeling of materials and waste
 Transportation of same
 Security of radioactive material
 Testing of equipment for radioactive hazards, et. al.
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
Nuclear Med
Must be maintained in safe operating
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
Nuclear Med
 Practitioner who interprets test must sign
and date the test and be approved by MS to
 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
Outpatient Services 1076
 Services must meet the needs of the patient
 Must be in accordance with standards of practice
such as ACR, AMA, ACS, etc.
 Optional service but must comply with all CoPs
 Both on and off campus
 Outpatient services must be integrated into
hospital QAPI
 Theme in rest of slides with being involved in PI,
qualified director, follow SOCs, and met needs of
Outpatient Services
Must be integrated with inpatient
Medical records, radiology, lab, anesthesia,
including pain management, diagnostic
Hospital must coordinate the care of the
Make sure pertinent information in medical
Outpatient Orders 1080
 Orders can be made by practitioner who is;
 Responsible for the care of the patient
 Licensed in state where patient is seen
 Within state scope of practice
 Authorized by the MS to order outpatient services
under written P&P
 P&P must be approved by the board
 Whether C&P by the hospital or not
 Verify is licensed in state and within scope (NP, PA)
Outpatient Services 2013
 Have appropriate professional and nonprofessional
personnel bases on scope and complexity of
outpatient services
 Define in writing the qualifications and
competencies necessary to direct the department
 Should include education, experience and training
 Will review P&P to determine person’s
 No longer a requirement to be sure that one person
is overlooking all of ambulatory patients care and
treatment (July 16, 2012)
Outpatient Tag 1079 2013
 The outpatient services department must be
accountable one or more individuals responsible
for the outpatient area
 No longer says it has to be single person responsible
 With appropriate personnel at each location where
outpatient services are rendered
 Hospital has flexibility to determine how to organize
their outpatient department
 Define in writing the qualifications and
competencies of each of the outpatient directors
Outpatient Tag 1079 2013
 Survey Procedures 482.54(b)
 Ask the hospital how it has organized its
outpatient services and to identify the
individual(s) responsible for providing direction
for outpatient services
 Review the organization’s policies and
procedures to determine the person’s
 Will review the position description of the
individuals responsible for outpatient services
Outpatient Services 1080
 Outpatient Services must meet the needs of the
patients in accordance with standards of practice
 Like AMA, ACR, ACS, etc.
 It is optional to have outpatient services but if
provides must follow CoPs
 Services, equipment, staff, and facilities must be
 Orders for outpatients may be made by practitioner
responsible for the care of the patient
 Licensed in state where he sees the patient
Outpatient Services 1080
 Authorized by the MS to order the outpatient
 Under written hospital policy approved by the board
and the Medical Staff (MS)
 This includes both those on and not on the medical
 Can decide to not accept chemo orders from referring
physician not on the MS
 Be integrated into PI
 Consider checking license, OIG excluded list of
individuals, verify order is from practitioner etc.
Emergency Services 1100
Hospital must meet needs of patients
Optional for Medicare
Must follow acceptable standards of
Must be integrated into hospital wide
Need qualified MS director
Emergency Services
 Services must be integrated with other dept in
 Surgery, lab, medical records, et al.
 Includes communications between
 Immediate availability of services, equipment,
and resources of hospital
 Length of time to transport between
departments is appropriate
Emergency Services
 Other departments must provide emergency
patients the care within safe and appropriate
 If offer urgent care on premises or in provider
based clinics must follow these regulations
 Remember there is a separate COP on
 Will review policies, including triage policy
Emergency Services
 Must have appropriate equipment
 Periodic assessments of its needs
 Work with state and feds in emergency
 Surveyor will interview staff to see if
knowledgeable about blood, IV fluid,
parenteral administration of electrolytes,
injuries to extremities, CNS and prevention
of infection
Rehab Services 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
 Read what must be in the plan of care
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
 Director must be knowledgeable and experience
and capable
 Will review job description
 Services must be furnished in accordance with
written plan of care
Rehab Services
 Must be given in accordance with order of
practitioner (no longer says physician only)
 Orders must be incorporated in the medical record
 Orders by one authorized by the MS to order and
by P&P
 Do not have to be C&P to order outpatient rehab
now based on March 23, 2012 changes as long as
licensed and meet the above criteria
 Plan of care must meet criteria such as based on
assessment, measurable short and long term goals,
updated as needed
Respiratory Services 1151
 Must meet needs of patients
 Acceptable standard of practice
 Appropriate equipment and number of
qualified personnel
 Scope of service should be defined in writing
 Director who is doctor with experience to
supervise service
 List of written policies you must have
Respiratory Policies
 Equipment assembly, operation, PM
 Safety practices including IC for sterile supplies,
biohaz waste, posting of signs and gas line id
 Pulmonary function testing
 Procedure to follow for activities of daily living
 Therapeutic percussion and vibration
 Bronchopulmonary drainage
Respiratory Policies
 Mechanical ventilation
 Aerosol, humidification, and therapeutic gas
 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
Respiratory Services 1164 (Last CoP)
 If blood gases or other clinical lab tests are
performed in unit then the applicable lab
standards must be met
 Need order of practitioner
 Will review medical records
 Will review to make sure all required policies
and procedures are written
 Statement of Deficiencies and Plan of
 Based on documentation of surveyor
worksheet or notes and form CMS-2567
The End! Questions???
 Sue Dill Calloway RN, Esq.
 President of Patient Safety and
Education Consulting
 Board Member
Emergency Medicine Patient
Safety Foundation
 614 791-1468
 Center for Disease Control CDC –
 Food and Drug Administration -
 Association of periOperative Registered Nurses at AORN
 American Institute of Architects AIA -
 Occupational Safety and Health Administration OSHA –
 National Institutes of Health NIH -
 United States Dept of Agriculture USDA -
 Emergency Nurses Association ENA -
 American College of Emergency Physicians ACEP
 Joint Commission Joint Commission
 Centers for Medicare and Medicaid Services CMS
 American Association for Respiratory Care AARC
 American College of Surgeons ACS
 American Nurses Association ANA -
 AHRQ is
 American Hospital Association AHA -
 U.S. Pharmacopeia (USP)
 U.S. Food and Drug Administration MedWatch
 Institute for Healthcare Improvement -
 AHRQ at
 Drug Enforcement Administration – (copy of
controlled substance act)
 US Pharmacopeia -, (USP 797 book for sale)
 National Patient Safety Foundation at the AMA
 The Institute for Safe Medication Practices -
 CMS Life Safety Code page
 American College of Radiology-
 Federal Emergency Management Agency (FEMA)
 Sentinel event alerts at
 American Pharmaceutical Association
 American Society of Heath-System Pharmacists
 Enhancing Patient Safety and Errors in Healthcare
 National Coordinating Council for Medication Error
Reporting and Prevention -,
 FDA's Recalls, Market Withdrawals and Safety
Alerts Page:
 Association for Professionals in Infection Control and
Epidemiology (APIC) infection control guidelines at
 Centers for Disease Control and Prevention -
 Occupational Health and Safety Administration (OSHA) at
Infection Control Websites
 The National Institute for Occupational Safety and
Health NIOSH at
 AORN at
 Society for Healthcare Epidemiology of America
(SHEA) at
The End!
Sue Dill Calloway RN, Esq.
5447 Fawnbrook Lane
Dublin, Ohio 43017

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