Safe Site Invasive Procedure Non-operating Room Protocol

8/6/2019 Safe Site Invasive Procedure Non-operating Room Protocol

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Health Care Protocol:

Non-OR Procedural Safety

Third Edition

August 2010

I ICSINSTITUTE FOR CLINICAL

SYSTEMSIMPROVEMENT

The information contained in this ICSI Health Care Protocol is intended primarily for health profes-

sionals and the following expert audiences:

physicians, nurses, and other health care professional and provider organizations;

health plans, health systems, health care organizations, hospitals and integrated health care

delivery systems;

health care teaching institutions;

health care information technology departments;

medical specialty and professional societies;

researchers;

federal, state and local government health care policy makers and specialists; and

employee benet managers.

This ICSI Health Care Protocol should not be construed as medical advice or medical opinion related to

any specic facts or circumstances. If you are not one of the expert audiences listed above you are urged

to consult a health care professional regarding your own situation and any specic medical questions

you may have. In addition, you should seek assistance from a health care professional in interpreting

this ICSI Health Care Protocol and applying it in your 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 orto establish a protocol for all patients with a particular condition. An ICSI Health Care Protocol rarely

will establish the only approach to a problem.

Copies of this ICSI Health Care Protocol may be distributed by any organization to the organization's

employees but, except as provided below, may not be distributed outside of the organization without

the prior written consent of the Institute for Clinical Systems Improvement, Inc. If the organization is

a legally constituted medical group, the ICSI Health Care Protocol may be used by the medical group

in any of the following ways:

copies may be provided to anyone involved in the medical group's process for developing and

implementing clinical protocols;

the ICSI Health Care Protocol may be adopted or adapted for use within the medical grouponly, provided that ICSI receives appropriate attribution on all written or electronic documents;

and

copies may be provided to patients and the clinicians who manage their care, if the ICSI Health

Care Protocol is incorporated into the medical group's clinical protocol program.

All other copyright rights in this ICSI Health Care Protocol are reserved by the Institute for Clinical

Systems Improvement. The Institute for Clinical Systems Improvement assumes no liability for any

adaptations or revisions or modications made to this ICSI Health Care Protocol.


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Health Care Protocol:

Non-OR Procedural SafetyI ICSINSTITUTE FOR CLINICAL

SYSTEMSIMPROVEMENT

www.icsi.org

Copyright 2010 by Institute for Clinical Systems Improvement 1

A = Annotation

Third Edition

August 2010

Pre-procedure evaluation,planning and

communication

1

Pre-procedure verificationof patient, procedure and

site

2

A

* Provider marks site withinitials if required

A

A

3

Able to resolvediscrepancy?

5

yes

A

Has time, team orlocation changedafter verification?

6

no

yes

* No mark required due topatient refusal, midline

structure, diagram used,imaging assistance, etc.

** For multiple procedures:1. Same procedure at different

sites: confirm next site aftercompletion of each.

2. Different procedures atmultiple sites: reverify with

the formal time-out process.3. For multiple teams: time-out

process for each team atbeginning of their procedure.

Confirmation that allverification steps are

completed; is discrepencyidentified?

4

A

Active time-outprocess with all team

members; isdiscrepencyidentified?

7

no

Able to resolvediscrepancy?

8

yes

** Complete procedure andcreate appropriatedocumentation prior to

patient leaving area

9

yes

no

Repeat verificationprocess; is discrepency

identified?

yes

10

Cancel procedure

no

no

Able to resolvediscrepency?

11

yes

yes

A

A

A

no

no

12


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Institute for Clinical Systems Improvement

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Non-OR Procedural SafetyThird Edition/August 2010

Table of Contents

Work Group LeaderMarietta Farris, BSN

Nursing, Fairview Health

ServicesWork Group MembersFamily Medicine

Christina E. Anderson, MD

Chippewa County

Montevideo Hospital &

Clinic

Shailendra Prasad, MBBS,

MPH

University of Minnesota

Neal C. Rucks, PA-C

Chippewa County

Montevideo Hospital &

ClinicPatient Safety & Quality

Stephanie Doty, MSN, MBA,

RN

HealthPartners Medical

Group and Regions Hospital

Radiology

Karen Landeen, RN

Hennepin County Medical

Center

Facilitators

Kerin Hanson, MA

ICSI

Kari Retzer, RN

ICSI

Janet Schuerman, MBA

ICSI

Algorithms and Annotations ....................................................................................... 1-12

Algorithm ........................................................................................................................... 1

Disclosure of Potential Conict of Interest ........................................................................ 3

Description of Evidence Grading ....................................................................................... 3

Foreword

Introduction ................................................................................................................... 4

Scope and Target Population ......................................................................................... 5

Aims .............................................................................................................................. 5

Clinical Highlights ........................................................................................................ 5

Implementation Recommendation Highlights .............................................................. 6

Related ICSI Scientic Documents .............................................................................. 6

Annotations ................................................................................................................... 7-12

Quality Improvement Support................................................................................ 13-18

Aims and Measures .......................................................................................................... 14

Measurement Specications ....................................................................................... 15

Implementation Recommendations .................................................................................. 16

Resources.......................................................................................................................... 16

Resources Table ........................................................................................................... 17-18

Supporting Evidence.................................................................................................... 19-28

References ........................................................................................................................ 20

Appendices .................................................................................................................. 21-28

Appendix A Denitions....................................................................................... 21-22

Appendix B List of Invasive, High-Risk or Non-Surgical Procedures .....................23

Appendix C Sample Checklists .......................................................................... 24-27

Appendix D Body Diagrams .....................................................................................28

Document History, Development and Acknowledgements.............................. 29-30

Document History ............................................................................................................29

ICSI Document Development and Revision Process .......................................................30


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Disclosure of Potential Conict of Interest

In the interest of full disclosure, ICSI has adopted a policy of revealing relationships work group members

have with companies that sell products or services that are relevant to this protocol topic. It is not assumed

that these nancial interests will have an adverse impact on content. They are simply noted here to fully

inform users of the protocol.No work group members have potential conicts of interest to disclose.

Evidence Grading

A consistent and dened process is used for literature search and review for the development and revi-

sion of ICSI Protocols. Literature search terms for the current revision of this document include Safe Site

Non-OR/Joint Commission 2009, Safe Site Non-OR/Joint Commission 2010, Safe Site Non-OR/CMS,

Safe Site Non-OR.

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 rst). A full explanation of ICSI's Evidence

Grading System can be found on the ICSI Web site at http://www.icsi.org.

Class DescriptionPrimary Reports of New Data Collections

A Randomized, controlled trialB Cohort-studyC Non-randomized trial with concurrent or historical controls

Case-control study

Study of sensitivity and specificity of a diagnostic test

Population-based descriptive studyD Cross-sectional study

Case series

Case reportReports that Synthesize or Reflect upon Collections of Primary Reports

M Meta-analysisSytematic review

Decision analysis

Cost-effectiveness analysisR Consensus statement

Consensus report

Narrative reviewX 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 an invasive or high-risk procedure. Please see Appendix A for denitions of 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 Universal Protocol, 2008 [NA]; Siddiqui, 2007 [R]). The Universal Protocol was created to

address the continuing occurrence of these medical events. The Universal Protocol became effective July 1,

2004, for all accredited hospitals, ambulatory care and ofce-based surgery facilities and drew upon, expanded

and integrated a series of requirements under The Joint Commission's National Patient Safety Goals (Joint

Commission National Patient Safety Goals, 2010 [NA]). It is applicable to all high-risk invasive procedures.

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 Physi-

cians, American College of Surgeons, American Dental Association and American Academy of Orthopedic

Surgeons.

In Minnesota, there are still patients affected by wrong procedure events outside of the operating room.

As part of the Minnesota Adverse Health Event law (Minnesota's Adverse Health Care Events law can be

found at: http://www.revisor.leg.state.mn.us/stats/144/sections 144.706 through 144.7069), these events are

reported directly to the state and are publicly disclosed. While the Fifth Annual Public Report of Adverse

Events in Minnesota does not specically distinguish adverse events occurring outside of the operating room

from those occurring elsewhere, it is estimated that approximately 40% of these events occur outside of the

operating room (Adverse Health Event in Minnesota Sixth Annual Public Report, 2010 [NA]).

In addition to requirements set by The Joint Commission, this protocol includes other components that are

important in fostering a culture of patient safety in a health care setting, such as purposeful team commu-

nication. An observational study has shown that ineffective team communication is often a root cause for

a medical event, and some ineffective team communications 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 complying

with this protocol. Patients should be as encouraged to be as involved they are able.

In order to involve patients as essential members of the health care team and engage them in processes

directed at reducing the risk of adverse events, efforts should be directed toward enhancing communication

and ensuring patient understanding. These efforts should include such things as procedure-specic patient

education materials and the involvement of interpreters as needed throughout the procedure process.



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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 ofce, procedural area, emergency department or at the bedside. The

protocol, while similar in process to safety measures used in operating room, takes into consideration theunique work of the different patient care areas listed, such as image-guided biopsies and procedures such

as PICC line placement where the insertion site is not predetermined. It covers the processes of patient

consent; identication; verication of procedure, site and patient; and the indications for site marking. A

diagram may be used as an alternative to marking; a sample is attached. Discussion of laterality, levels,

multiple sites and multiple procedures is also included.

As the goal of the Universal Protocol is "to improve patient safety and prevent procedural errors," and insti-

tutional consistency may improve overall compliance and safety, 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 benet derived from these practices also appliesto pediatric patients.

Aim

1. Eliminate wrong site, side, patient or procedure events performed outside of the operating room.

Clinical Highlights

Procedure sites will be marked with the initials of the provider. The provider will conrm 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 conrmationby all the caregivers involved in the care of the patient. The patient should be involved if possible.

(Annotation #9)

If site determination is done at the time of the procedure using imaging, verbal conrmation should occur

with team/patient, and documentation should reect use of imaging for site determination. (Annotation

#3)

The Time-Out procedure will be repeated for each different anatomically distinct procedure. (Annota-

tion #9)

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Implementation Recommendation Highlights

The following system changes were identied by the protocol work group as key strategies for health care

systems to incorporate in support of the implementation of this protocol.

1. For ongoing success of this protocol, leadership support, a local/unit-based champion and a multidis-

ciplinary steering team are absolutely essential.

2. Establish pre-procedure and intra-procedural communication standards in the form of structured hand-

offs, huddles, pre-procedure briengs, etc.

3. 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 C for a sample Pre-Procedure

hard copy checklist, and for a sample checklist within an Electronic Medical Record [EMR]).

4. A visual reminder to complete the Time-Out is recommended.

Related ICSI Scientic Documents

Protocols

Perioperative Protocol

Non-OR Procedural SafetyForeword Third Edition/August 2010


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Algorithm Annotations

1. Pre-Procedure Evaluation, Planning and CommunicationVerication 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 infor-

mation 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

veries 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 commu-

nication) 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.

2. Pre-Procedure Verication of Patient, Procedure and SiteWith the patient awake and aware if possible, the provider involved in the care of the patient will conrm

the patient's identity, procedure and site by comparing the following:

Patient's identity, using two identiers

Procedure name and site in the informed consent documentation

Information in the medical record

Diagnostic studies

Discussion with the patient/legal guardian

Interventional radiology: the lesion/site may be identied using intra-procedural imaging, in which

case it cannot be marked on the skin. The use of intra-procedural imaging for site verication will

then be recorded in the Time-Out documentation.



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The ultimate responsibility for procedure and site verication lies with the provider performing the proce-

dure.

See Appendix C, "Sample Checklists," for examples of process documentation.

3. Provider Marks Site with Initials if RequiredFor imaging guided procedures, if the side or individual structure is known prior to the procedure start, the

site should be marked on the skin.

This 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 some procedures, the entry site, best approach or treatment site is determined during the rst phase of

the procedure using radiologic imaging. Verbal conrmation of the nal site selection should take place

among the provider, the team and the patient (if possible) and documentation following the procedure should

reect the use of imaging to determine the site.

For procedures performed by anesthesia When an anesthesiologist is performing a nerve block orepidural 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 multiple sites/digits on the same anatomic site The procedures should be identied by an anatomical

name on the informed consent documentation and the sites marked.

For procedures involving laterality The informed consent documentation will indicate the laterality, and

the site will be marked accordingly.

Laterality also applies to procedures that have a midline or orice entry but the internal target location

involves laterality. The laterality for procedures entered via midline or orice entry will be indicated on the

informed consent documentation. See the denition of "Site" in Appendix A for more information.For bilateral procedures, both sites will be marked.

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).

General exceptions to site marking include but are not limited to:

Emergency procedures

Midline structures

Single organ cases (cardiac procedures)

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

Interventional procedures where the insertion site is not predetermined (e.g., cardiac catheterization,

peripherally inserted central catheters, central lines, arteriogram)

Non-OR Procedural SafetyAlgorithm Annotations Third Edition/August 2010


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Procedures that enter through an orice 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)

Patient refusals A dened procedure should be in place for documentation of a patient refusal of site

marking

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. All the essential

patient identiers, 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

When site marking does not apply, it should be noted as such in the procedure note/checklist according to

individual facility policies.

The work group recommends the provider performing the procedure verify the patient's identity, correct

site and side of the procedure, and mark the procedure site using his/her initials with the patient involved,

awake and aware, if possible. Prior to marking the procedure site location, the site will be conrmed through

a review of:

procedure name and site identication in the informed consent documentation,

information in the medical record,

diagnostic studies, and

discussion with the patient/legal guardian.

The procedure site will be initialed using an indelible marker and will be visible when the patient is

positioned, prepped and draped. Patients for whom permanent marking/tattooing is a concern (e.g., burn

patients, premature babies, physical location that cannot be marked, and patients who refuse site marking),

the protocol calls for the use of a diagram to identify the correct site. Sample diagrams are provided inAppendix D, "Body Diagrams."

4. Conrmation That All Verication Steps Are Completed; Is

Discrepency Identied?If any part of the verication process is not followed and/or a discrepancy is discovered, the procedure is

halted and will not continue until the discrepancy is resolved.

Resolution of discrepancies will include:

Reverication of patient identication

Review of the information in the informed consent documentation

Review of the medical record

Review of diagnostic studies

Discussion with the patient/legal guardian (if appropriate)



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5. Able to Resolve Discrepancy?Discrepancy:

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 with what the

patient/legal guardian states is being done, patient identication, consent, site, site marking, medical record,imaging, procedure scheduled, team members and/or lack of available equipment. 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:

Reverication of patient identication

Review of the information in the informed consent documentation

Review of the medical record

Review of diagnostic studies

Discussion with the patient/legal guardian

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 verication process will be

repeated.

If the steps of the verication process cannot be completed and/or a discrepancy cannot be resolved,

the procedure is cancelled and rescheduled.

6. Has Time, Team or Location Changed After Verication?There are any number of reasons for the care team to change. If any staff changes or additions (such as

hand-off, tech-to-tech, observers, lab personnel, specimens, etc.) take place before the procedure is started,the team member involved in procedure and procedural support should conrm the patient's information

including the verication 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

Appendix A, "Denitions," "Structured Hand-Off."

7. Active Time-Out Process with All Team Members; Is Discrepency

Identied?The Time-Out is to be performed immediately prior to the start of the procedure and is the nal safety stop

before the procedure is begun. Every Time-Out must include the following standard elements:

Patient identity, using a minimum of two identiers

Procedure(s) to be performed (including internal and/or external laterality, multiples and/or level)

Patient positioning if not already veried

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)



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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 they agree 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

inuence 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 referto 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 C, "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 identication 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 (i.e., 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).

8. Able to Resolve Discrepancy?See Annotation #5, "Able to Resolve Discrepancy?"

9. Complete Procedure and Create Appropriate Documentation Prior

to Patient Leaving AreaIf the patient is having multiple procedures with different sites, whether or not the procedures are different,

an abbreviated Time-Out will be performed. Multiple procedures are numbered on the consent form with

corresponding numbers marked on the patient's skin. When the provider is starting a new procedure at a

different site, the procedure number is referenced on the consent form and veried with the number markedon the patient. A member of the team will read 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



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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 leftcheek and dorsal left hand

At the completion of the procedure, the provider will create an immediate post-procedure note for patients

being moved to another level of care. If the procedure note is being dictated, an abbreviated note will sufce.

10. Repeat Verication Process; Is Discrepency Identied?If the procedure time changes, if the provider or care team changes, or if the patient is moved, a repeat

verication is required. Refer to verication components in Annotation #2, "Pre-Procedure Verication of

Patient, Procedure and Site."

11. Able to Resolve Discrepancy?See Annotation #5, "Able to Resolve Discrepancy?"



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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

- Measurement Specications

Implementation Recommendations

Resources

Resources Table

I ICSINSTITUTE FOR CLINICAL

SYSTEMSIMPROVEMENT

Quality Improvement Support:


Copyright 2010 by Institute for Clinical Systems Improvement


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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.

Possible 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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Measurement Specication

Possible Success Measurement #11a. Decreased number of wrong invasive or high-risk procedure events outside of the operating room per

month.

Population DenitionPatients of all ages who have an invasive or high-risk procedure done outside of the operating room.

Data of Interest# of wrong events

Total # of procedures per month

Numerator and Denominator DenitionsNumerator: A wrong event is dened as a wrong procedure, a procedure performed on the wrong

patient, or a procedure performed on the wrong side, site or level.

Denominator: Total number of non-OR procedures.

Method/Source of Data CollectionEvent data should be reported through an incident or sentinel event report or per the organization's policy

for reporting.

Data Collection Time FrameThe suggested time period is a calendar month, but three months could be consolidated into quarterly data

points if caseload and/or event numbers are small.

Non-OR Procedural SafetyAims and Measures Third Edition/August 2010


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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

Culture and the need to shift values, beliefs and behaviors of the organization

The following system changes were identied by the work group as key strategies for health care systems

to incorporate in support of the implementation of this protocol.

1. For ongoing success of this protocol, leadership support, a local/unit-based champion and a multidis-

ciplinary steering team are absolutely essential.

2. Establish pre-procedure and intra-procedural communication standards in the form of structured hand-

offs, huddles, pre-procedure briengs, etc.

3. 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 C for a sample Pre-Procedure

hard copy checklist, and for a sample checklist within an Electronic Medical Record [EMR]).

4. A visual reminder to complete the Time-Out is recommended.

Resources

Criteria for Selecting Resources

The following resources were selected by the Non-OR Procedural Safetyprotocol work group as additional

resources for providers and/or patients. The following criteria were considered in selecting these resources.

The site contains information specic to the topic of the protocol.

The content is supported by evidence-based research.

The content includes the source/author and contact information.

The content clearly states revision dates or the date the information was published.

The content is clear about potential biases, noting conict of interest and/or disclaimers as

appropriate.

Resources Available to ICSI Members Only

ICSI has a wide variety of knowledge resources that are only available to ICSI members (these are indicatedwith an asterisk in far left-hand column of the Resources Available table). In addition to the resources listed

in the table, ICSI members have access to a broad range of materials including tool kits on CQI processes

and Rapid Cycling that can be helpful. To obtain copies of these or other Knowledge Resources, go to

http://www.icsi.org/improvement_resources. To access these materials on the Web site, you must be logged

in as an ICSI member.

The resources in the table on the next page that are not reserved for ICSI members are available to the

public free-of-charge.


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* Author/Organization Title/Description Audience Web Sites/Order Information

American College of

Radiology

The principal organization of

radiologists, radiation oncologists,

and clinical medical physicists in

the United States, with more than

30,000 members.

Health Care

Providers

http://www.acr.org/Secondary-

MainMenuCategories/quality_safe-

ty.aspx

American College of

Surgeons

The ACS is a scientic and

educational association of surgeons

established to improve the quality of

care for surgical patients by setting

high standards for surgical education

and practice.

The Web site provides informa-

tion for health care providers and

patients.

Health Care

Providers;

Patients and

Families

http://www.facs.org

Agency for Healthcare

Research and Quality

(AHRQ)

Safety and quality tips for consum-

ers.

Patients and

Families

http://www.ahrq.gov/consumer/

The Centers for Medi-

care and Medicaid

Services (CMS)

Quality initiatives overview and

links to specic information.

Health Care

Providers

http://www.cms.gov/QualityInitia-

tivesGenInfo

Institute for Healthcare

Improvement (IHI)

5M Lives Campaign

IHI is a not-for-prot organization

for improvement of health care

throughout the world.

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 Preven-

tion is one of the initiatives of the

5M Lives Campaign.

There are tools and kits in the

"Prevent Surgical Site Infection"

section.

Health Care

Providers

http://www.ihi.org/IHI/Programs/

Campaign/Campaign.htm

Institute for Safe Medi-

cation Practices (ISMP)

Alerts patients to frequent medica-

tion 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 Commis-

sion's Universal Protocol

Health Care

Providers

http://www.jointcommission.org

Resources Table

* Available to ICSI members only.



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* Author/Organization Title/Description Audience Web Sites/Order Information

The Leapfrog Group Quality and safety information about

hospitals that consumers can search.

Patients and

Families

http://www.leapfroggroup.org/

for_consumers

The Minnesota Alli-

ance for Patient Safety(MAPS)

Award winning partnership

advancing patient safety in MN.

Health Care

Providers

http://www.mnpatientsafety.org

Minnesota Department

of Health

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 Infor-

mation

Hyperlinks to variety of Web sites

related to cost and quality, informa-

tion about managing chronic health

conditions and staying healthy.

Patients and

Families

http://www.minnesotahealthinfo.

org

Minnesota Hospital

Association

Safe Site Call to Action

Web site includes tools that addressprocedures outside the OR.

Health Care

Providers

http://www.mnhospitals.org

National Academy for

State Health Policy

(NASHP)

Assists states in achieving excel-

lence in health policy and practice,

resources compare patient safety

initiatives and approaches.

Health Care

Providers

http://www.nashp.org

Society of Interventional

Radiologists

National organization of physicians,

scientists and allied health profes-

sionals dedicated to improving

public health through disease

management and minimally in-

vasive, image-guided therapeutic

interventions.

Physicians,

Scientists,

Allied Health

Professionals

http://www.sirweb.org/medical-

professionals/

Stratis Health Minnesota's Medicare Quality

Improvement Organization, pro-

vides health literacy information

and project / quality improvement

opportunities.

Health Care

Providers;

Patients and

Families

http://www.stratishealth.org/exper-

tise/safety/

NCPS VA National

Center for Patient Safety

United States Veteran's Administra-

tion

Health Care

Providers

http://www.patientsafety.gov

Non-OR Procedural SafetyResources Table Third Edition/August 2010

* Available to ICSI members only.


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19Copyright 2010 by Institute for Clinical Systems Improvement

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

I ICSINSTITUTEFOR CLINICAL

SYSTEMS IMPROVEMENT

Supporting Evidence:


The subdivisions of this section are:

References

Appendices


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20

References

Adverse Health Events in Minnesota. Sixth Annual Public Report. Available at: http://www.jointcom-mission.org/AccreditationPrograms/Ofce-BasedSurgery/Standards/09_FAQs/default.htm. (Class Not

Assignable)The Joint Commission. National patient safety goals. Available at http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/. (Class Not Assignable)

The Joint Commission. Universal protocol frequently asked questions about the universal protocol forpreventing wrong site, wrong procedure, wrong person surgery. Available at http://www.jointcommis-

sion.org/PatientSafety/UniversalProtocol/. July 2010. (Class Not Assignable)

The Joint Commission. Universal protocol for preventing wrong site, wrong procedure, wrong person

surgery. Available at http://www.jointcommission.org/NR/rdonlyres/E3C600EB-043B-4E86-B04E-CA4A89AD5433/0/universal_protocol.pdf. (Class Not Assignable)

Lingard L, Espn S, Whyte S, et al. Communication failures in the operating room; an observation clas-sication of recurrent types and effects. Qual Saf Health Care2004;13:330-34. (Class D)

Siddiqui MT. Pathologist performed ne needle aspirations & implementation of JCAHO universal

protocol and "time out." CytoJournal2007;4:19. (Class R)



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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 identication, 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 verication process has not been followed

completely and/or there is a discrepancy identied.

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 B, "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 orice 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).

Level refers to any anatomical structures that include multiples occurring linearly (e.g., spinal vertebrae,

ribs).

Provider is a member of the team performing the procedure who is credentialed and privileged as dened

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 ndings of the initial procedure. These should follow this

same process for site marking and verication as predetermined procedures.

Site is dened as the specic 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, 2nd, 3rd, 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 specied 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 is when only one person is involved in performing an invasive procedure.

Source document refers to an original radiology or pathology report that identies laterality and/or speci-

es anticipated procedural location.

Structured hand-offis a standardized method of communication used to improve the exchange of informa-

tion 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

Appendix A Denitions



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Non-OR Procedural SafetyAppendix A Denitions Third Edition/August 2010

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 verication that is performed immediately prior to the start of the procedure and is the

nal safety stop before the procedure is begun. Every Time-Out must include the following standard elements:

Patient's identity, using a minimum of two identiers

Procedure(s) to be performed (including internal and/or external laterality, multiples and/or level)

Patient positioning if not already veried

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)

Verication is dened as checking for consistency between the:

informed consent documentation;

diagnostic studies if applicable; and

response of the patient/legal guardian, if able.

Special CircumstancesAnatomical 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 conrm the correct

procedure site. This may include additional imaging or a second physician conrming the procedure site.

Single Provider: There are invasive procedures that may involve only one provider. Even when there is

only one person doing the procedure, an abbreviated Time-Out to conrm the correct patient, procedure and

site is appropriate. It is not necessary to engage others in this verication process if they would not otherwise

be involved in the procedure (The Joint Commission Universal Protocol Frequently Asked Questions Aboutthe Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, 2008 [NA]).


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Any procedures involving skin incision

Any procedures involving general or regional anesthesia, monitored anesthesia care, or conscious seda-tion

Injections of any substance into a joint space or body cavity

Percutaneous aspiration of body uids or air through the skin (e.g., arthrocentesis, bone marrow aspira-

tion, 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, stent-

implantation, 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

Venipuncture

Manipulation and reduction

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 May 17, 2010, at

http://www1.va.gov/vhapublications/publications.cfm?pub=1.

Appendix B List of Invasive, High-Risk orNon-Surgical Procedures *



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Appendix C Sample Checklists

Used with permission. Minnesota Hospital Association Safe Site Call-To-Action Toolkit, 2009.

Pre-Procedure Verification ChecklistInvasive 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 Communication1. Team communication completed ..................................................................................................

Team reviewed relevant case information including:

- Images and diagnostic/pathology/lab reports ......Yes ( ) N/A ( )- Anticipated equipment is available ......................Yes ( ) N/A ( )- Antibiotics or fluids for irrigation ...........................Yes ( ) N/A ( )- Posit ioning .......................................... ...................Yes ( ) N/A ( )- Additional safety precautions, e.g. allergies ........Yes ( ) N/A ( )

Just Prior to Procedure (Time-out)

1. Person performing the procedure initiated the time-out verbally ................................................

2. All other activity ceased .................................................................................................................

3. 2nd

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:


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Non-OR Procedural SafetyAppendix C Sample Checklists Third Edition/August 2010

Sample electronic format used by Hennepin County Medical Center.

Electronic Checklist of Pre-Procedure Assessment,Pre-Procedure Verication and Time-Out


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29/31


30/31

29Copyright 2010 by Institute for Clinical Systems Improvement

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

I ICSINSTITUTEFOR CLINICAL

SYSTEMS IMPROVEMENT

Document Drafted

JuneJuly 2008

First EditionOct 2008

Second Edition

Oct 2009

Third Edition

Begins Aug 2010

Document History, Development and Acknowledgements:


Original Work Group Members

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 RegionsHospital

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

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 & Cinic

Cally Vinz, RN

FacilitatorICSI

Released in July 2010 for Third Edition.

The next scheduled revision will occur within 24 months.

Document History

In response to ICSI hospital member's patient safety activities aimed at advancing efcient surgical process

ow 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 specically 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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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 manage-

ment of a given symptom, disease or condition for patients.

Document Development and Revision Process

The development process is based on a number of long-proven approaches. ICSI staff rst conducts a literature

search to identify pertinent clinical trials, meta-analysis, systematic reviews, regulatory statements and other

professional protocols. The literature is reviewed and graded based on the ICSI Evidence Grading System.

ICSI facilitators identify gaps between current and optimal practices. The work group uses this informa-

tion to develop or revise the clinical ow and algorithm, drafting of annotations and identication of the

literature citations. ICSI staff reviews existing regulatory and standard measures and drafts outcome and

process measures for work group consideration. The work group gives consideration to the importance

of changing systems and physician behavior so that outcomes such as health status, patient and provider

satisfaction, and cost/utilization are maximized.

Medical groups, who are members of ICSI, review each protocol as part of the revision process. The medical

groups provide feedback on new literature, identify areas needing clarication, offer recommended changes,

outline successful implementation strategies and list barriers to implementation. A summary of the feed-

back from all medical groups is provided to the protocol work group for use in the revision of the protocol.

Implementation Recommendations and Measures

Each protocol includes implementation strategies related to key clinical recommendations. In addition, ICSI

offers protocol-derived measures. Assisted by measurement consultants on the protocol development work

group, ICSI's measures ow from each protocol's clinical recommendations and implementation strategies.

Most regulatory and publicly reported measures are included but, more importantly, measures are recom-

mended to assist medical groups with implementation; thus, both process and outcomes measures are offered.

Document Revision Cycle

Scientic 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 signicant

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 rst version of a protocol.
