Health Care Protocol
Non-OR Procedural Safety
How to cite this document:
Farris M, Anderson C, Doty S, Myers C, Johnson K, Prasad S. Institute for Clinical Systems Improvement.
Non-OR Procedural Safety. Updated September 2012.
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•
copies may be provided to anyone involved in the medical group’s process for developing and
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Health Care Protocol:
Non-OR Procedural Safety
Text in blue in this algorithm
indicates a linked corresponding
annotation.
1
Pre-procedure evaluation,
planning and
communication
Fourth Edition
September 2012
2
* No mark required due to
patient refusal, midline
structure, diagram used,
imaging assistance, etc.
Pre-procedure verification
of patient, procedure and
site
3
* Provider marks site with
initials if required
4
Confirmation that all
verification steps are
completed; is discrepancy
identified?
yes
no
10
6
5
Repeat verification
process; is discrepancy
identified?
Has time, team or
location changed
after verification?
yes
no
yes
Able to resolve
discrepancy?
no
no
yes
7
11
Able to resolve
discrepancy?
Active Time-Out
process with all team
members; is
discrepancy
identified?
yes
no
no
yes
8
no
Able to resolve
discrepancy?
yes
9
** Complete procedure and
create appropriate
documentation prior to
patient leaving area
** For multiple procedures:
1. Same procedure at different
sites: confirm next site after
completion of each.
2. Different procedures at
multiple sites: reverify with
the formal Time-Out process.
3. For multiple teams: Time-Out
process for each team at
beginning of their procedure.
12
Cancel procedure
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Copyright © 2012 by Institute for Clinical Systems Improvement
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Non-OR Procedural Safety
Fourth Edition/September 2012
Table of Contents
Work Group Leader
Marietta Farris, BSN
Nursing, Fairview Health
Services
Work Group Members
Chippewa County –
Montevideo Hospital &
Clinic
Christina E. Anderson, MD
Family Medicine
HealthPartners Medical
Group and Regions
Hospital
Stephanie Doty, MSN, MBA,
RN
Patient Safety & Quality
University of Minnesota
Shailendra Prasad, MBBS,
MPH
Family Medicine
ICSI
Kari Johnson, RN
Clinical Systems
Improvement Facilitator
Cassie Myers
Systems Improvement
Coordinator
Algorithm and Annotations........................................................................................... 1-14
Algorithm..............................................................................................................................1
Evidence Grading..................................................................................................................3
Foreword
Introduction......................................................................................................................4
Scope and Target Population............................................................................................5
Aim..................................................................................................................................5
Clinical Highlights...........................................................................................................5
Implementation Recommendation Highlights.................................................................6
Related ICSI Scientific Documents.................................................................................6
Definitions.................................................................................................................... 6-7
Special Considerations.....................................................................................................8
Annotations..................................................................................................................... 9-14
Quality Improvement Support. ................................................................................. 15-21
Aims and Measures.............................................................................................................16
Measurement Specifications.................................................................................... 17-18
Implementation Recommendations.....................................................................................19
Implementation Tools and Resources..................................................................................19
Implementation Tools and Resources Table.................................................................. 20-21
Supporting Evidence..................................................................................................... 22-32
References...........................................................................................................................23
Appendices.................................................................................................................... 24-32
Appendix A – List of Invasive, High-Risk or Non-Surgical Procedures.......................24
Appendix B – Sample Checklists.............................................................................25-28
Appendix C – Body Diagrams................................................................................. 29-32
Disclosure of Potential Conflicts of Interest........................................................... 33-34
Acknowledgements. ....................................................................................................... 35-36
Document History and Development....................................................................... 37-38
Document History...............................................................................................................37
ICSI Document Development and Revision Process..........................................................38
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Evidence Grading
Literature Search
A consistent and defined process is used for literature search and review for the development and revision
of ICSI protocols. The literature search was divided into two stages to identify systematic reviews (stage I)
and randomized controlled trials, meta-analysis and other literature (stage II). Literature search terms used
for this revision are below and include literature from January 1, 2010, through May 1, 2012.
The PubMed database was searched for literature. Limited searches included universal protocol for wrong
site in radiology, endoscopy or catheter labs, bedside procedures, and clinics. Other search terms included
wrong site and outside the OR/operating room, wrong site and non-OR, near-miss events, true events, wrong
procedure, wrong site and surgical safety.
Individual research reports are assigned a letter indicating the class of report based on design type: A, B,
C, D, M, R, X.
Evidence citations are listed in the document utilizing this format: (Author, YYYY [report class]; Author,
YYYY [report class] – in chronological order, most recent date first).
Class
Description
Primary Reports of New Data Collections
A
Randomized, controlled trial
B
Cohort-study
C
Non-randomized trial with concurrent or historical controls
Case-control study
Study of sensitivity and specificity of a diagnostic test
Population-based descriptive study
D
Cross-sectional study
Case series
Case report
Reports that Synthesize or Reflect upon Collections of Primary Reports
M
Meta-analysis
Sytematic review
Decision analysis
Cost-effectiveness analysis
R
Consensus statement
Consensus report
Narrative review
X
Medical opinion
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Foreword
Introduction
The purpose of this safety protocol is to eliminate events involving the wrong patient, wrong site or wrong
procedure during high-risk invasive or high-risk procedure performed in the non-operating room setting.
Please see the Definitions section for key terms used throughout the protocol.
This protocol is consistent with and based heavily on The Joint Commission's Board of Commissioners
approved Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery (Joint
Commission, The, 2012 [NA]; Siddiqui, 2007 [R]). The Universal Protocol was created in an attempt to
address the continuing occurrence of these medical events. The Universal Protocol became effective July
1, 2004, for all accredited hospitals, ambulatory care and office-based surgery facilities, and drew upon,
expanded and integrated a series of requirements under The Joint Commission's National Patient Safety
Goals (Joint Commission, The, 2012 [NA]).
The Universal Protocol is endorsed by nearly 50 professional health care associations and organizations
including the American Medical Association, American Hospital Association, American College of Physicians, American College of Surgeons, American Dental Association and American Academy of Orthopedic
Surgeons.
As part of the Minnesota Adverse Health Event law which can be found at http://www.revisor.leg.state.mn.us/
stats/144/sections 144.706 through 144.7069 – wrong site, procedure and patient events are reported directly
to the Minnesota Department of Health and are disclosed to the public on an annual basis. Fortunately,
while these events are very rare (1:50,000 invasive procedures including the operating room), facilities
in Minnesota continue to work hard at preventing wrong site, wrong patient and wrong procedure events
outside of the operating room. The Eighth Annual Public Report of Adverse Events in Minnesota states that
36% of the total wrong site, patient or procedure events occurred in non-operating room settings (Minnesota
Department of Health, Eighth Annual Public Report, 2012 [NA]).
In addition to providing guidance on implementing the elements of Universal Protocol as defined by The
Joint Commission, this protocol addresses other components such as purposeful team communication, that
are important in fostering a culture of patient safety in a health care setting. An observational study has
shown that ineffective team communication is often a root cause for a medical event, and ineffective team
communications can have immediate, negative effects on patient safety (Lingard, 2004 [D]).
The work of implementing this protocol requires coordination among the provider, the patient/legal guardian,
the patient's nurse, the procedural team, radiology personnel, emergency department staff and anesthesia
practitioners, as well as many others. All staff/providers involved must take an active role in participating
with this protocol to ensure its effectiveness.
Patients or surrogates should be encouraged to participate, if able, as essential members of the health care
team and should be engaged in processes designed to reduce the risk of adverse events. Participation may
include the patient or surrogate in the pre-procedure verification process.
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Foreword
Scope and Target Population
There are clinical reasons for a procedure to take place outside of an operating room. This protocol is
applicable for all patients having an invasive, high-risk, diagnostic or therapeutic procedure performed
not in the operating room but in an office, procedural area, emergency department or at the bedside. The
protocol, while similar in process to safety measures used in operating room, takes into consideration the
unique work of the different patient care areas listed, e.g., image-guided biopsies and procedures such as
PICC line placement where the insertion site is not predetermined. It covers the processes of patient consent;
identification; verification of procedure, site and patient; and the indications for site-marking. A diagram
may be used as an alternative to marking; see Appendix C, "Body Diagrams," for examples. Discussion of
laterality, levels, multiple sites and multiple procedures is also included.
The goal of the Universal Protocol is "to improve patient safety and prevent procedural errors." Institutional consistency may improve overall compliance and safety, and institutions may consider a more broad
application of this algorithm rather than a more limited one (e.g., inclusion of electroconvulsive therapy
[ECT], dialysis and radiation).
Much of the evidence used to derive these recommendations is from studies involving adult patients.
However, the work group has made the assumption that the benefit derived from these practices also applies
to pediatric patients.
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Aim
1. Eliminate wrong site, side, patient or procedure events performed outside of the operating room.
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Clinical Highlights
•
Procedure sites will be marked with the initials of the provider. The provider will confirm the patient's
identity, procedure(s) and site(s) prior to initialing the site. For bilateral procedures, both sides will be
marked. (Annotation #3)
•
A Time-Out will be performed just prior to the start of the procedure, with active verbal confirmation
by all the caregivers involved in the care of the patient. The patient should be involved if possible.
(Annotation #7)
•
If site determination is done at the time of the procedure using imaging, verbal confirmation should occur
with team/patient, and documentation should reflect use of imaging for site determination. (Annotation
#3)
•
The Time-Out procedure will be repeated for each different anatomically distinct procedure. (Annotation #9)
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Foreword
Implementation Recommendation Highlights
The following system changes were identified by the protocol work group as key strategies for health care
systems to incorporate in support of the implementation of this protocol.
•
For ongoing success of this protocol, leadership support, a local/unit-based champion and a multidisciplinary steering team are absolutely essential.
•
Establish pre-procedure and intra-procedural communication standards in the form of structured handoffs, huddles, pre-procedure briefings, etc.
•
Create a process that addresses how to document completion of each step and ensure that all elements
of the protocol are completed. A checklist may be used (see Appendix B, "Sample Checklists," for
a sample Pre-Procedure hard copy checklist, and for a sample checklist within an electronic medical
record [EMR]).
•
A visual reminder to complete the Time-Out is recommended.
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Related ICSI Scientific Documents
Protocols
•
Perioperative Protocol
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Definitions
Clinician – All health care professionals whose practice is based on interaction with and/or treatment of a
patient.
Discrepancy is any disagreement over the plan for the patient. A discrepancy in the plan of care could
develop or be found at any point in the Safe Site Process. The discrepancy could be found with what the
patient/legal guardian states is being done, patient identification, consent, site, site-marking, medical record,
imaging, procedure scheduled, team members and/or lack of available equipment.
Hard stop is a cessation of activity. It is performed when the verification process has not been followed
completely and/or there is a discrepancy identified.
High-risk invasive procedure is any procedure that is known to expose a patient to the risk of serious
harm or permanent loss of function or injury. Generally, this includes procedures requiring consent by the
patient. Refer to Appendix A, "List of Invasive, High-Risk or Non-Surgical Procedures," for examples.
Intra-procedure pause is a pause during the procedure(s); the provider will indicate verbally:
•
level(s),
•
internal laterality after a midline or orifice entry, or
•
implant information.
Laterality refers to any anatomical structure that occurs on both sides of the body, either internally or
externally (e.g., right, left or bilateral). Reference to laterality is always with respect to the patient (e.g., the
patient's right or left, not the provider's).
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Non-OR Procedural Safety
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Foreword
Level refers to any anatomical structures that include multiples occurring linearly (e.g., spinal vertebrae, ribs).
Patient identifiers are used first, to reliably identify the individual as the person for whom the service or
treatment is intended: second, to match the service or treatment to that individual. Acceptable methods for
identifying a patient include the individual's name, an assigned identification number, telephone number or
other person-specific identifier.
Provider is a member of the team performing the procedure who is credentialed and privileged as defined
by the institution's medical staff bylaws or who is a physician in residency training.
Position refers to the placement or angle of the patient for the procedure (e.g., supine, prone). Reference to
position is important when determining laterality.
Possibles refer to possible sites and/or procedures listed on the patient consent, and the decision whether to
perform the additional procedure is based on the findings of the initial procedure. These should follow this
same process for site-marking and verification as predetermined procedures.
Site is defined as the specific anatomic location of the procedure site (incision, insertion or injection) as
indicated by a description of the body part(s), levels (e.g., spine level or ribs), and digits (for hands, use
thumb, index, long, ring, small; for toes, use great toe, second, third, etc.) to be subjected to intervention.
Midline not associated with laterality or level need not be marked. However, if the internal target site
involves laterality, and laterality is specified on the consent, the provider should verbally state site upon
entry. For spinal procedures, the incision site – anterior or posterior – and general level (cervical, thoracic
or lumbar) are marked.
Single provider one and only person involved in performing an invasive procedure.
Source document refers to an original radiology or pathology report that identifies laterality and/or specifies anticipated procedural location.
Structured hand-off is a standardized method of communication used to improve the exchange of information
during care transitions. The purpose of a structured hand-off is to promote patient safety by ensuring that
critical pieces of information are conveyed to the next individual assuming care responsibilities, including
such things as critical test results, patient status, recent/anticipated changes in patient condition, plan of care/
goals, what to watch for in the next interval of care, etc. This should be a process used by all caregivers
and should be done during a patient transition from one caregiver to another. This should be done face to
face to encourage discussion and questions.
Time-Out is the full verification that is performed immediately prior to the start of the procedure and is the
final safety stop before the procedure is begun. Every Time-Out must include the following standard elements:
•
Patient's identity, using a minimum of two patient identifiers
•
Procedure(s) to be performed (including internal and/or external laterality, multiples and/or level)
•
Patient positioning if not already verified
•
Procedure side, site and/or level including visualization of the provider's initials if applicable
•
As appropriate, imaging, equipment, implants or special requirements (e.g., pre-procedure antibiotic
administration)
Verification is defined as checking for consistency between the:
•
informed consent documentation;
•
diagnostic studies if applicable; and
•
response of the patient/legal guardian, if able.
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Non-OR Procedural Safety
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Foreword
Special Considerations
Anatomical Variation: When a patient is known to have anatomical variation involving the procedure
site, this information should be shared with the care team and additional steps taken to confirm the correct
procedure site. This may include additional imaging or a second physician confirming the procedure site.
Single Provider: There are invasive procedures that may involve only one provider. If possible, engage
the patient or surrogate in the pre-procedure verification process by asking the patient or surrogate to state
the procedure to be performed. This pre-procedure verification is especially important if the provider leaves
the patient's room/bedside before performing the invasive procedure.
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Algorithm Annotations
1. Pre-Procedure Evaluation, Planning and Communication
Verification of the consistency of all patient/procedural information (patient's name, date of birth, medical
record number, planned procedure, procedural site and laterality, as applicable) ideally begins at the point
of scheduling.
It is recommended that facilities establish a process to verify the consistency of all patient/procedural information upon receipt of procedure-related documents. Potential sources include:
•
procedural consent,
•
radiology reports,
•
pathology reports,
•
laboratory results,
•
procedural orders,
•
medical records, and
•
physician referrals.
This could take the form of a checklist including the date and signature of the individual who receives and
verifies that data are consistent on each document as received.
All documentation should be provided by paper, fax or electronic format (not by phone or verbal communication) except in emergent/urgent situations. Ideally, the patient should be provided the same information
in hard copy form to bring to the appointment/procedure.
Discrepancies in the consistency of patient name, date of birth, medical record number, planned procedure,
procedural site or laterality should be:
•
addressed immediately upon discovery, and
•
guided by a process (e.g., unit supervisor informed).
Planning for the procedure must not continue until the discrepancy is resolved.
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2. Pre-Procedure Verification of Patient, Procedure and Site
With the patient awake the providers/clinicians involved in the care, along with the patient/legal guardian
and/or family member will confirm the patient's identity, procedure and site by comparing the following:
•
Patient's identity, using two patient identifiers.
•
Procedure name and site in the informed consent documentation. Multiple procedures are numbered
on the consent form with corresponding numbers marked on the patient's skin.
•
Information in the medical record.
•
Diagnostic studies.
•
Discussion with the patient/legal guardian.
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Algorithm Annotations
•
Interventional radiology: the lesion/site may be identified using intra-procedural imaging, in which
case it cannot be marked on the skin. The use of intra-procedural imaging for site verification will
then be recorded in the Time-Out documentation.
The ultimate responsibility for procedure and site verification lies with the provider performing the procedure.
See Appendix B, "Sample Checklists," for examples of process documentation.
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3. Provider Marks Site with Initials if Required
The provider performing the procedure holds the responsibility for following the correct site-marking process.
See the definition of "Site" in the "Definitions" section for more information.
General exceptions to site-marking include but are not limited to:
•
Emergency procedures
•
Midline structures
•
Single organ cases (cardiac procedures)
Site-marking has the following characteristics and expectations:
•
Site-marking is done following the identification of the patient, review of the consent and other
related images as required, and with the patient/family taking part in the process, if able.
•
The procedure site will be initialed by the provider using his/her initials with an indelible marker
and will be placed such that it is visible when the patient is positioned, prepped and draped.
•
Both sites will be marked for bilateral procedures as noted on the consent form.
•
For multiple sites/digits on the same anatomical site: each procedure must be numbered independently
on the informed consent documentation and each site marked with the appropriate corresponding
number.
•
For independent procedures on paired anatomical sites (e.g., ears): each procedure must be numbered
independently on the informed consent documentation and each site marked with the appropriate
corresponding number.
•
For procedures involving level (spine or ribs) – The informed consent documentation will indicate
the laterality and level, and the site will be marked in a way to indicate anterior or posterior and
general level (cervical, thoracic, lumbar, or rib number).
•
For imaging-guided procedures, if the side or individual structure is known prior to the procedure
start, the site should be marked on the skin.
•
Site-marking is also necessary when direct puncture into the area of interest is done based on external
landmarks, history or prior studies (rather than intra-procedural imaging) and there is a possibility
for left/right or level events.
•
For procedures performed by anesthesia – When an anesthesiologist is performing a nerve block
or epidural that involves laterality or spine levels, the site should be marked with an "A" with a
circle around it to differentiate it from the proceduralist's initials even when the only procedure
being performed is by the anesthesiologist.
•
For some procedures, the entry site, best approach or treatment site is determined during the first
phase of the procedure using radiologic imaging. Verbal confirmation of the final site selection
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Algorithm Annotations
should take place between the provider, the team and the patient (if possible), and documentation
following the procedure should reflect the use of imaging to determine the site.
Procedures and situations requiring the use of site-marking diagram:
There should be a written process providing direction on when and how to use the site-marking diagram
and how to record this information in the medical record. Guidelines for the use of the diagram include:
•
When the site is technically or anatomically impossible to mark, (such as a mucosal surface or
perineum).
•
Teeth – Indicate operative tooth name(s) on informed consent documentation, or mark the operative
tooth (teeth) on the dental radiographs or dental diagram.
•
Premature infants for whom the mark may cause a permanent tattoo. No infants under the corrected
gestational age of 38 weeks should be marked.
•
Patient refusals to have skin marked – A defined procedure should be in place for documentation
of a patient refusal of site-marking, along with the use of the site-marking diagram.
•
The use of the diagram should be considered for patients with tattoos at the operative site and the
site mark may not be clearly visible.
•
The use of the diagram should be considered for patients with anatomical abnormalities that may
lead to confusion as to the correct site.
Other situations:
Site-marking is not required when the provider performing the procedure is in continuous physical presence
with the patient from arrival for the procedure to conclusion of the procedure. Continuous physical presence means the provider does not leave the room where the procedure will be preformed. All the essential
patient identifiers, consents, medical records, x-rays and the necessary equipment must be present in the
room, and the provider does not leave the room for any reason.
•
Interventional procedures where the insertion site is not predetermined (e.g., cardiac catheterization,
peripherally inserted central catheters, central lines, arteriogram).
•
Procedures that enter through an orifice where the target organ is not associated with laterality (e.g.,
endoscopies, cystoscopy, laryngoscopy).
•
Site-sensitive areas that may be marked above or lateral to the procedure site (e.g., scrotal sites will
be marked on the groin area on the appropriate side of the body; breast sites will be marked on the
breast or above the breast on the upper chest area).
Sample diagrams are provided in Appendix C, "Body Diagrams."
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4. Confirmation That All Verification Steps Are Completed; Is
Discrepancy Identified?
A discrepancy is any disagreement over the plan for the patient. A discrepancy in the plan of care could
develop or be found at any point in the Safe Site Process. The discrepancy could be found when the patient/
legal guardian states what is being done during patient identification/consent/site-marking, medical record,
imaging, when the procedure is scheduled, and from team members and/or lack of available equipment.
If any part of the verification process is not followed and/or a discrepancy is discovered, the procedure is
halted and will not continue until the discrepancy is resolved.
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Algorithm Annotations Resolution of discrepancies will include:
•
•
•
•
•
Reverification of patient identification, with at least two patient identifiers (name/medical record
number or name/date of birth)
Review of the information in the informed consent documentation
Review of the medical record
Review of diagnostic studies
Discussion with the patient/legal guardian/family member (if appropriate)
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5. Able to Resolve Discrepancy?
When a discrepancy is found, the procedure and/or preparation is halted and will not continue until the
discrepancy is resolved. This may include a hard stop, meaning the scalpel, needle or cutting/incising device
is not handed to the provider until the discrepancy is resolved.
The complete process for resolution of discrepancies must include the following items:
• Reverification of patient identification with at least two patient identifiers
• Review of the information in the informed consent documentation
•
Review of the medical record
•
Discussion with the patient/legal guardian/family member
•
Review of diagnostic studies
Conversations related to solution of discrepancies will be held in a quiet location, away from activity and
distractions. After the discrepancy has been resolved, the procedure and site verification process will be
repeated.
If the steps of the verification process cannot be completed and/or a discrepancy cannot be resolved,
the procedure is cancelled and rescheduled.
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6. Has Time, Team or Location Changed After Verification?
There are any number of reasons for the care team to change. If any staff changes or additions (such as handoff, tech-to-tech, observers, lab personnel, etc.) take place, the team member(s) involved in procedure and
procedural support should confirm the patient's information including the verification of the patient, procedure
and the site. All hand-offs in care before, during or after the procedure should follow a standard process/
format that has been agreed upon by the facility. See the "Definitions" section for "Structured Hand-Off."
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7. Active Time-Out Process with All Team Members; Is Discrepancy
Identified?
The Time-Out is to be performed immediately prior to the start of the procedure and is the final safety step
before the procedure is begun. Every Time-Out must include the following elements:
•
Patient identity, using a minimum of two patient identifiers
•
Patient positioning if not already verified
•
Procedure(s) to be performed (including internal and/or external laterality, multiples and/or level)
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Algorithm Annotations
•
•
Procedure side, site and/or level including visualization of the provider's initials if applicable
As appropriate, imaging, equipment, implants or special requirements (e.g., pre-procedure antibiotic
administration)
The Time-Out is to be initiated by the provider and includes active verbal acknowledgment by all members
of the team. During the Time-Out, each person in the procedure room must stop what he or she is doing and
actively participate in the process. No individual is exempt from the process. Active participation requires
each individual to state clearly and loudly that he or she agrees with the elements of the Time-Out. The
scalpel, needle or other cutting/incising device is not to be handed to the provider until the Time-Out has
been completed.
Environmental distractions are to be eliminated as much as possible during the Time-Out. For example,
music is turned off, pagers are set on vibrate, talking other than participation in Time-Out ceases, and no
staff are permitted to enter or exit the room. If during the Time-Out an interruption or distraction occurs
(pager goes off or an individual enters the room), the Time-Out must be restarted. While it is desirable to
actively include the patient in the Time-Out, it is not always possible, particularly if the patient is under the
influence of sedating medications or is otherwise unable to participate.
It is recommended that a visual memory aid be used to trigger the initiation of the Time-Out. For example,
a "Time-Out" sign or towel can be used to cover the scalpel, needle or cutting/incising device as a reminder
to conduct the Time-Out.
The provider may delegate the Time-Out elements to the nurse or other member of the team, but the initiation
of the Time-Out should be the responsibility of the provider. The nurse or other team member may refer
to the patient consent for the Time-Out elements. However, prior to its use, the consent must have been
validated against other documents such as history and physical, radiology or pathology reports, progress
notes, etc. See Appendix B, "Sample Checklists."
Additional Time-Outs are to be performed when there are two or more different procedures performed on
the same patient during the same procedure period, whether or not the procedures involve a new procedure
team. The process and elements of the Time-Out as described above must occur prior to the start of the next
procedure. Additional patient identification should be conducted when there is a change in team composition.
If the patient needs to be repositioned during the procedure and this repositioning affects the patient's
presentation (e.g., the patient is turned prone), an abbreviated Time-Out including the site, side, level and/
or visualization of the provider's initials will be conducted. The Time-Out process will be the same as
described above (e.g., elimination of distractions, active participation).
The Time-Out process is a final check prior to the actual procedure being performed. It is recommended
that the process be documented in the medical record as a marker of safety procedures. The documentation
should reflect the person initiating the Time-Out process; the identification by the second provider of the
patient, the site and the procedure being performed, and the completeness of the consent process.
Return to Algorithm
Return to Table of Contents
8. Able to Resolve Discrepancy?
See Annotation #5, "Able to Resolve Discrepancy?"
Return to Algorithm
Return to Table of Contents
9. Complete Procedure and Create Appropriate Documentation Prior
to Patient Leaving Area
When the provider is starting a new procedure at a different site, the procedure number is referenced on the
consent form and verified with the number marked on the patient. A member of the team will read
Return to Algorithm
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13
Non-OR Procedural Safety
Fourth Edition/September 2012
Algorithm Annotations
the procedure and number from the consent form. Each member of the team will verbally acknowledge
the procedure being performed prior to starting. This process is completed every time the location and/or
procedure changes. Examples include:
•
Multiple procedures – different sites
-
•
Biopsy of atypical lesions: face, scalp and right forearm
Different procedures – multiple sites
-
Cryosurgery actinic keratoses: right cheek, nose, left ear, right forearm, right hand. Incision
and drainage cyst at upper back, biopsy of atypical lesion right lower back
-
Cryosurgery verruca at right heel. Biopsy atypical lesion at right leg
-
Cryosurgery actinic keratoses at left arm, right arm, nose and left ear. Biopsy lesion at left
cheek and dorsal left hand
At the completion of the procedure, the provider will create an immediate post-procedure note into the
medical record. If the procedure note is being dictated, an abbreviated note will suffice. A final note should
include a notation that a Time-Out had been completed.
Return to Algorithm
Return to Table of Contents
10.Repeat Verification Process; Is Discrepancy Identified?
If the procedure time changes, if the provider or care team changes, or if the patient is moved, a repeat
verification is required. Refer to verification components in Annotation #2, "Pre-Procedure Verification of
Patient, Procedure and Site."
Return to Algorithm
Return to Table of Contents
11.Able to Resolve Discrepancy?
See Annotation #5, "Able to Resolve Discrepancy?"
Return to Algorithm
Return to Table of Contents
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Quality Improvement Support:
Non-OR Procedural Safety
The Aims and Measures section is intended to provide protocol users with a menu
of measures for multiple purposes that may include the following:
• population health improvement measures,
• quality improvement measures for delivery systems,
• measures from regulatory organizations such as Joint Commission,
• measures that are currently required for public reporting,
• measures that are part of Center for Medicare Services Physician Quality
Reporting initiative, and
• other measures from local and national organizations aimed at measuring
population health and improvement of care delivery.
This section provides resources, strategies and measurement for use in closing
the gap between current clinical practice and the recommendations set forth in the
protocol.
The subdivisions of this section are:
• Aims and Measures
• Implementation Recommendations
• Implementation Tools and Resources
Copyright © 2012 by Institute for Clinical Systems Improvement
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Non-OR Procedural Safety
Fourth Edition/September 2012
Aims and Measures
Outcome Aim and Measure
1. Eliminate wrong site, side, patient for invasive or high-risk procedure events performed outside of the
operating room.
Measures for accomplishing this aim:
a. Wrong invasive or high-risk procedure events per month.
b. Rate of wrong invasive or high-risk procedure events per month.
c. Rate of observational compliance.
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Non-OR Procedural Safety
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Aims and Measures
Measurement Specifications
Measurement #1a/1b
1a. Wrong invasive or high-risk procedure events per month.
1b. Rate of wrong invasive or high-risk procedure events per month.
Population Definition
Patients of all ages who have an invasive or high-risk procedure done outside of the operating room (any
non-OR setting).
Data of Interest
1a. Number of wrong invasive or high-risk procedures events per month.
1b.
# of wrong events
Total # of procedures per month
Numerator and Denominator Definitions
Numerator:
Number of wrong invasive or high-risk procedure events per month. Note: a wrong event
is defined as a wrong invasive or high-risk procedure performed on the wrong patient, or a
procedure performed on the wrong side, site or level.
Denominator:
Total number of non-OR procedures per month.
Method/Source of Data Collection
Collect the number of total invasive or high-risk procedures done monthly. Determine from chart audits or
event data whether any of these were wrong events. Event data should be reported through an incident or
sentinel event report or per the organization's policy for reporting.
Data Collection Time Frame
The suggested time period is a calendar month, but three months could be consolidated into quarterly data
points if case load and/or event numbers are small.
Notes
This is an outcome measure, and the improvement goal is no wrong events.
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Non-OR Procedural Safety
Fourth Edition/September 2012
Aims and Measures
Measurement #1c
Rate of observational compliance.
Population Definition
Patients of all ages who have an invasive or high-risk procedure done outside of the operating room (any
non-OR setting).
Data of Interest
# of invasive or high-risk procedures that met observational compliance
Total # of invasive or high-risk procedures outside of OR
Numerator and Denominator Definitions
Numerator:
Number of invasive or high-risk procedure that met observational compliance.
Denominator:
Total number of non-OR procedures per month.
Method/Source of Data Collection
Collect the number of total invasive or high-risk procedures done monthly. Determine from chart audits or
event data the number that met observational compliance. Event data should be reported through an incident
or sentinel event report or per the organization's policy for reporting.
Data Collection Time Frame
The suggested time period is a calendar month, but three months could be consolidated into quarterly data
points if case load and/or event numbers are small.
Notes
This is an outcome measure, and improvement is noted as an increase in the rate.
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Non-OR Procedural Safety
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Implementation Recommendations
Prior to implementation, it is important to consider current organizational infrastructure that address the
following:
•
System and process design;
•
Training and education; and
•
Culture and the need to shift values, beliefs and behaviors of the organization.
The following system changes were identified by the protocol work group as key strategies for health care
systems to incorporate in support of the implementation of this protocol:
•
For ongoing success of this protocol, leadership support, a local/unit-based champion and a multidisciplinary steering team are absolutely essential.
•
Establish pre-procedure and intra-procedural communication standards in the form of structured handoffs, huddles, pre-procedure briefings, etc.
•
Create a process that addresses how to document completion of each step and ensure that all elements
of the protocol are completed. A checklist may be used (see Appendix B, "Sample Checklists," for
a sample Pre-Procedure hard copy checklist, and for a sample checklist within an electronic medical
record [EMR]).
•
A visual reminder to complete the Time-Out is recommended.
Return to Table of Contents
Implementation Tools and Resources
Criteria for Selecting Resources
The following tools and resources specific to the topic of the protocol were selected by the work group.
Each item was reviewed thoroughly by at least one work group member. It is expected that users of these
tools will establish the proper copyright prior to their use. The types of criteria the work group used are:
•
The content supports the clinical and the implementation recommendations.
•
Where possible, the content is supported by evidence-based research.
•
The author, source and revision dates for the content are included where possible.
•
The content is clear about potential biases and when appropriate conflicts of interests and/or
disclaimers are noted where appropriate.
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Non-OR Procedural Safety
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Implementation Tools and Resources Table
Author/Organization
American College of
Radiology
Audience
Health Care
Providers
Web Sites/Order Information
http://www.acr.org/Quality-Safety
The ACS is a scientific and
educational association of surgeons
established to improve the quality of
care for surgical patients by setting high
standards for surgical education and
practice.
Health Care
Providers;
Patients and
Families
http://www.facs.org
Agency for Healthcare
Research and Quality
(AHRQ)
Safety and quality tips for consumers.
Patients and
Families
http://www.ahrq.gov/consumer/
The Centers for Medicare and Medicaid
Services (CMS)
Quality initiatives overview and links to Health Care
specific information.
Providers
American College of
Surgeons
Institute for Healthcare
Improvement (IHI)
Title/Description
The principal organization of radiologists, radiation oncologists, and clinical
medical physicists in the United States,
with more than 30,000 members.
Provides links for quality and safety.
The Web site provides information for
health care providers and patients.
5M Lives Campaign
IHI is a not-for-profit organization for
improvement of health care throughout
the world.
http://www.cms.gov/QualityInitiativesGenInfo
Health Care
Providers
http://www.ihi.org/IHI/Programs/
Campaign/Campaign.htm
The 5 Million Lives Campaign is an
initiative to engage U.S. hospitals to
implement changes to improve patient
care and prevent avoidable deaths.
Surgical Infection Prevention is one of
the initiatives of the 5M Lives
Campaign.
There are tools and kits in the
"Prevent Surgical Site Infection"
section.
Institute for Safe Medication Practices (ISMP)
Alerts patients to frequent medication
events and how to avoid them, and
general medication safety advice.
Patients and
Families
http://www.ismp.org/newsletters/
consumer/consumeralerts.asp
The Joint Commission
Site includes The Joint Commission's
Universal Protocol
Health Care
Providers
http://www.jointcommission.org
The Leapfrog Group
Quality and safety information about
hospitals that consumers can search.
Patients and
Families
http://www.leapfroggroup.org/
for_consumers
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Non-OR Procedural Safety
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Resources Table
Author/Organization
The Minnesota Alliance for Patient Safety
(MAPS)
Minnesota Department
of Health
Title/Description
Award winning partnership advancing
patient safety in MN.
Audience
Health Care
Providers
Web Sites/Order Information
http://www.mnpatientsafety.org
The site provides patient safety information that includes adverse event
reporting and information for consumers
and patients.
Health Care
Providers;
Patients and
Families
http://www.health.state.mn.us/
patientsafety/index.html
Minnesota Health Information
Hyperlinks to variety of Web sites
related to cost and quality, information
about managing chronic health conditions and staying healthy.
Patients and
Families
http://www.minnesotahealthinfo.
org
Minnesota Hospital
Association
Safe Site Call to Action
Health Care
Providers
http://www.mnhospitals.org
National Academy for
State Health Policy
(NASHP)
Assists states in achieving excellence
in health policy and practice, resources
compare patient safety initiatives and
approaches.
Health Care
Providers
http://www.nashp.org
Physicians,
Scientists,
Allied Health
Professionals
http://www.sirweb.org/medicalprofessionals/
Health Care
Providers;
Patients and
Families
http://www.stratishealth.org/expertise/safety/
Web site includes tools that address
procedures outside the OR.
Society of Interventional National organization of physicians,
Radiologists
scientists and allied health professionals dedicated to improving public health
through disease management and minimally invasive, image-guided therapeutic interventions.
Stratis Health
NCPS – VA National
Center for Patient Safety
Minnesota's Medicare Quality Improvement Organization, provides health
literacy information and project / quality
improvement opportunities.
United States Veteran's Administration
Health Care
Providers
http://www.patientsafety.gov
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Supporting Evidence:
Non-OR Procedural Safety
The subdivisions of this section are:
• References
• Appendices
Copyright © 2012 by Institute for Clinical Systems Improvement
22
Non-OR Procedural Safety
Fourth Edition/September 2012
References
Links are provided for those new references added to
this edition (author name is highlighted in blue).
Joint Commission, The. The universal protocol for preventing wrong site, wrong procedure, and wrong
person surgeryTM. Available at http://www.jointcommission.org/standards_information/standards.aspx.
(Class Not Assignable)
Lingard L, Espn S, Whyte S, et al. Communication failures in the operating room; an observation classification of recurrent types and effects. Qual Saf Health Care 2004;13:330-34. (Class D)
Minnesota Department of Health. Adverse health events in Minnesota. Eighth Annual Public Report.
Available at: http://www.health.state.mn.us/patientsafety/ae/2012ahereport.pdf. (Class Not Assignable)
Siddiqui MT. Pathologist performed fine needle aspirations & implementation of JCAHO universal
protocol and "time out." Cytojournal 2007;4:19. (Class R)
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Non-OR Procedural Safety
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Appendix A – List of Invasive, High-Risk or
Non-Surgical Procedures *
•
Any procedures involving skin incision
•
Injections of any substance into a joint space or body cavity
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Any procedures involving general or regional anesthesia, monitored anesthesia care, or conscious sedation
Percutaneous aspiration of body fluids or air through the skin (e.g., arthrocentesis, bone marrow aspiration, lumbar puncture, paracentesis, thoracentesis, suprapubic catheterization, chest tube)
Biopsy (e.g., bone marrow, breast, liver, muscle, kidney, genitourinary, prostate, bladder, skin)
Cardiac procedures (e.g., cardiac catheterization, cardiac pacemaker implantation, angioplasty, stentimplantation, intra-aortic balloon catheter insertion, elective cardioversion)
Endoscopy (e.g., colonoscopy, bronchoscopy, esophagogastric endoscopy, cystoscopy, percutaneous
endoscopic gastrostomy, J-tube placements, nephrostomy tube placements)
Invasive radiological procedures (e.g., angiography, angioplasty, percutaneous biopsy)
Dermatology procedures (biopsy, excision and deep cryotherapy for malignant lesions – excluding
cryotherapy for benign lesions)
Invasive ophthalmic procedures including miscellaneous procedures involving implants
Oral procedures including tooth extraction or gingival biopsy
Podiatric invasive procedures (e.g., removal of ingrown toenail)
Skin or wound debridement
Electroconvulsive therapy
Radiation oncology procedures
Central line placements or PICC
Kidney stone lithotripsy
Colposcopy and/or endometrial biopsy
Procedures NOT considered surgical, high-risk or invasive include:
•
Electrocautery of lesion
•
Manipulation and reduction
•
•
•
•
•
•
•
Venipuncture
Chemotherapy/oncology procedures
Intravenous therapy
Nasogastric tube insertion
Foley catheter insertion
Flexible sigmoidoscopy
Vaginal exams
* This list is not meant to be comprehensive. It partially draws from the United States Department of
Veterans Affairs. The PDF version of VHA Directive 2010-023 was last accessed on September 1,
2012, at http://www1.va.gov/vhapublications/publications.cfm?pub=1.
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Non-OR Procedural Safety
Fourth Edition/September 2012
Appendix B – Sample Checklists
Pre-Procedure Verification Checklist
Invasive Procedures Outside the Operating Room
If at any time during this process, there is a discrepancy of information, call for a “Hard Stop” –
all activity ceases until information is reconciled.
Pre-Procedure – Verification
1. Patient identification verified using two indicators .......................................................................
2. Accurate and complete informed consent verified.......................................................................
3. Procedure verified using at least two independent source documents
• Provider order, diagnostic images, radiology/pathology reports, patient understanding
of the procedure, informed consent .......................................................................................
4. Site marked, as appropriate*, by person performing the procedure with initials: ......................
*Refer to provider policy for site marking exclusions
•
Multiple sites marked and identified in the informed consent ..............................................
•
Diagram marked by person performing the procedure if unable to mark on patient……..
o Site was not marked due to:
( ) Site marking not required per policy
( ) Provider is in continuous attendance with the patient
( ) Refused by patient
Health Care Provider Signature:
_________________________________________________________________
Pre-Procedure – Communication
1. Team communication completed ..................................................................................................
Team reviewed relevant case information including:
o
- Images
and diagnostic/pathology/lab reports ......Yes ( )
- Anticipated equipment is available ......................Yes ( )
- Antibiotics or fluids for irrigation ...........................Yes ( )
- Positioning .............................................................Yes ( )
- Additional safety precautions, e.g. allergies ........Yes ( )
•
N/A (
N/A (
N/A (
N/A (
N/A (
)
)
)
)
)
Just Prior to Procedure (Time-out)
1. Person performing the procedure initiated the time-out verbally ................................................
2. All other activity ceased .................................................................................................................
3. 2
nd
health care provider verbally:
• Verified patient and procedure including side/site.........................................................
• Verified visualization and location of the site mark, if applicable .................................
4. Person performing the procedure verbally:
• Verified procedure including side/site .............................................................................
Health Care Provider Signature:
Used with permission. Minnesota Hospital Association Safe Site Call-To-Action Toolkit, 2009.
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Appendix B – Sample Checklists
Non-OR Procedural Safety
Fourth Edition/September 2012
Electronic Checklist of Pre-Procedure Assessment,
Pre-Procedure Verification and Time-Out
Sample
electronic format used by Hennepin County Medical Center.
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26
Appendix B – Sample Checklists
Sample electronic format used by Hennepin County Medical Center.
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27
Appendix B – Sample Checklists
Non-OR Procedural Safety
Fourth Edition/September 2012
Sample electronic format used by Hennepin County Medical Center.
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Non-OR Procedural Safety
Fourth Edition/September 2012
Appendix C – Body Diagrams
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Appendix C – Body Diagrams
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Appendix C – Body Diagrams
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Appendix C – Body Diagrams
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32
Disclosure of Potential Conflicts of Interest:
Non-OR Procedural Safety
ICSI has long had a policy of transparency in declaring potential conflicting and
competing interests of all individuals who participate in the development, revision
and approval of ICSI protocols and protocols. In 2010, the ICSI Conflict of Interest Review Committee was established by the
Board of Directors to review all disclosures and make recommendations to the board
when steps should be taken to mitigate potential conflicts of interest, including
recommendations regarding removal of work group members. This committee
has adopted the Institute of Medicine Conflict of Interest standards as outlined in
the report, Clinical Practice Protocols We Can Trust (2011).
Where there are work group members with identified potential conflicts, these are
disclosed and discussed at the initial work group meeting. These members are
expected to recuse themselves from related discussions or authorship of related
recommendations, as directed by the Conflict of Interest committee or requested
by the work group.
The complete ICSI Policy regarding Conflicts of Interest is available at
http://bit.ly/ICSICOI.
Funding Source
The Institute for Clinical Systems Improvement provided the funding for this
protocol revision. ICSI is a not-for-profit, quality improvement organization
based in Bloomington, Minnesota. ICSI's work is funded by the annual dues of
the member medical groups and five sponsoring health plans in Minnesota and
Wisconsin. Individuals on the work group are not paid by ICSI, but are supported
by their medical group for this work.
ICSI facilitates and coordinates the protocol development and revision process. ICSI, member medical groups and sponsoring health plans review and provide
feedback, but do not have editorial control over the work group. All recommendations are based on the work group's independent evaluation of the evidence.
Return to Table of Contents
Copyright © 2012 by Institute for Clinical Systems Improvement
33
Non-OR Procedural Safety
Fourth Edition/September 2012
Disclosure of Potential Conflicts of Interest
Christina Anderson, MD (Work Group Member)
Family Physician, Family Medicine,
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: ICSI Rapid Response Team Protocol
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Stephanie Doty, MSN, MBA, RN (Work Group Member)
Director of Patient Safety, Patient Safety and Quality Department, Regions Hospital
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: ICSI Rapid Response Team Protocol; ICSI Prevention of Retained Foreign
Objects During Labor and Delivery Protocol; ICSI Perioperative Protocol; ICSI Committee on EvidenceBased Practice
Research Grants: None
Financial/Non-Financial Conflicts of Interest: holds stock in 3M
Marietta Farris, BSN, MAN (Work Group Leader)
Nurse Manager, Medical/Surgical, Fairview Health Services, University of Minnesota Medical Center
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Shailendra Prasad, MBBS, MPH (Work Group Member)
Assistant Professor, Family Medicine, University of Minnesota
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
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Acknowledgements:
Non-OR Procedural Safety
All ICSI documents are available for review during the revision process by
member medical groups and sponsors. In addition, all members commit to
reviewing specific documents each year. This comprehensive review provides
information to the work group for such issues as content update, improving
clarity of recommendations, implementation suggestions and more. The
specific reviewer comments and the work group responses are available to
ICSI members at http://bit.ly/NonOR0912.
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Copyright © 2012 by Institute for Clinical Systems Improvement
35
Non-OR Procedural Safety
Fourth Edition/September 2012
Acknowledgements
Invited Reviewers
During this revision, the following medical groups reviewed this document. The work group would like to
thank them for their comments and feedback.
Gillette Children's Specialty Healthcare, St. Paul, MN
Minnesota Gastroenterology, St. Paul, MN
Planned Parenthood of Minnesota, North Dakota, South Dakota, St. Paul, MN
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Document History and Development:
Non-OR Procedural Safety
Document Drafted
June – July 2008
First Edition
Oct 2008
Second Edition
Oct 2009
Third Edition
Aug 2010

Fourth Edition
Begins Oct 2012
The next revision will be no later than October 2017.
Original Work Group Members
Kristy Enger, CMA
Clinic
Chippewa County –
Montevideo Hospital & Clinic
Marietta Farris, BSN
Nursing, Co-Work Group Leader
Fairview Health Services
Karin K. Fjeldos-Sperbeck, RN
Nursing
Sanford Health
Joann Foreman, RN
Facilitator
ICSI
Lisa Hurt, RN
Home Health Services
Ridgeview Medical Center
Nancy Jaeckels
Measurement/Implementation
Advisor
ICSI
Janet Jorgenson-Rathke, PT
Measurement/Implementation
Advisor
ICSI
Loree Kalliainen, MD, FACS
Plastic Surgery, Co-Work Group
Leader
HealthPartners Regions
Hospital
Stephanie Lach, MSN, MBA,
RN
Patient Safety & Quality
HealthPartners Regions
Hospital
Karen Landeen, RN
Radiology
Hennepin County Medical
Center
Neal C. Rucks, PA-C
Clinic
Chippewa County –
Montevideo Hospital & Clinic
Cally Vinz, RN
Facilitator
ICSI
Document History
In response to ICSI hospital member's patient safety activities aimed at advancing efficient surgical process flow and
creating safe and reliable practices that reduced the number of adverse events in surgery, in 2007 ICSI developed
surgical protocols to allow for standardization in surgical processes such as safe site-marking, retained foreign objects
and reduction of surgical site infection.
In recognizing the many differences that exist specifically for safe site-marking for procedures outside of the operating
room, a separate protocol was created in 2008 addressing just safe site-marking for procedures outside of the operating
room. This protocol was consistent with the requirements set forth at that time by the The Joint Commission National
Patient Safety Goals.
Additionally, in 2007-2008 ICSI facilitated a Reliability Centered Surgical Care Redesign Collaborative, which provided
a collaborative learning environment for participants to become knowledgeable in reliability theory and principles.
This collaborative provided an opportunity for participants to share their learnings as they worked to implement this
and other surgical related protocols.
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Contact ICSI at:
8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax)
Online at http://www.ICSI.org
Copyright © 2012 by Institute for Clinical Systems Improvement
37
Non-OR Procedural Safety
Fourth Edition/September 2012
ICSI Document Development and Revision Process
Overview
Since 1993, the Institute for Clinical Systems Improvement (ICSI) has developed more than 60 evidence-based
health care documents that support best practices for the prevention, diagnosis, treatment or management of a
given symptom, disease or condition for patients.
Audience and Intended Use
The information contained in this ICSI Health Care Protocol is intended primarily for health professionals and
other expert audiences.
This ICSI Health Care Protocol should not be construed as medical advice or medical opinion related to any
specific facts or circumstances. Patients and families are urged to consult a health care professional regarding their
own situation and any specific medical questions they may have. In addition, they should seek assistance from
a health care professional in interpreting this ICSI Health Care Protocol and applying it in their individual case.
This ICSI Health Care Protocol is designed to assist clinicians by providing an analytical framework for the
evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a
protocol for all patients with a particular condition.
Document Development and Revision Process
The development process is based on a number of long-proven approaches and is continually being revised
based on changing community standards. The ICSI staff, in consultation with the work group and a medical
librarian, conduct a literature search to identify systematic reviews, randomized clinical trials, meta-analysis, other
protocols, regulatory statements and other pertinent literature. This literature is evaluated based on the GRADE
methodology by work group members. When needed, an outside methodologist is consulted.
The work group uses this information to develop or revise clinical flows and algorithms, write recommendations,
and identify gaps in the literature. The work group gives consideration to the importance of many issues as they
develop the protocol. These considerations include the systems of care in our community and how resources
vary, the balance between benefits and harms of interventions, patient and community values, the autonomy of
clinicians and patients and more. All decisions made by the work group are done using a consensus process.
ICSI's medical group members and sponsors review each protocol as part of the revision process. They provide
comment on the scientific content, recommendations, implementation strategies and barriers to implementation.
This feedback is used by and responded to by the work group as part of their revision work. Final review and
approval of the protocol is done by ICSI's Committee on Evidence-Based Practice. This committee is made up
of practicing clinicians and nurses, drawn from ICSI member medical groups.
Implementation Recommendations and Measures
These are provided to assist medical groups and others to implement the recommendations in the protocols. Where
possible, implementation strategies are included which have been formally evaluated and tested. Measures are
included which may be used for quality improvement as well as for outcome reporting. When available, regulatory or publicly reported measures are included.
Document Revision Cycle
Scientific documents are revised every 12-24 months as indicated by changes in clinical practice and literature.
Each ICSI staff monitors major peer-reviewed journals every month for the protocols for which they are responsible. Work group members are also asked to provide any pertinent literature through check-ins with the work
group mid-cycle and annually to determine if there have been changes in the evidence significant enough to
warrant document revision earlier than scheduled. This process complements the exhaustive literature search
that is done on the subject prior to development of the first version of a protocol.
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