Final Report Briefing

Retained Foreign ObjectPerformance Improvement Team

Presented April 3, 2007

GOAL::Eliminate the sentinel event of retained foreign objects (RFO)

Team LeaderDr. John Skibber

Team MembersDr. Miguel Rodriguez-BigasDr. Ara Vaporciyan Dr. Peter PistersDr. Bharat RavalJudith Gerst Rolando Ramirez Susan Terrell Lisa McMillian

Team Members (cont.)Nadine TurnerPamela BennettTammy CampbellAloma SmithIrvin Serra Ronald Portley

Recorder/CoordinatorSteven Foster

Administrative AssistanceMelina Scarborough

Technical ConsultantJim Vinci, Holland and Davis, LLP

TIMELINE:Start date - Oct 2006Scheduled completion date – Feb. 28, 2007Actual completion date – Mar. 30, 2007

TIME CONSIDERATIONS:Complexity of taskChange in team leadershipTechnology exploration

METHODOLOGY

1. Chartered by Dr. Burke2. Action plan developed3. Team tasking list developed4. Statistics gathered

A. Existing reports B. Ad Hoc

5. Regulations acquired6. Policies & mandates acquired7. Benchmarking completed8. Interim reports to OR Committee

9. “As-Is” Process mapped A. Flowchart B. Responsibility Assignment Matrix

10. Root Cause Analysis conducted11. Best practices considered12. Value Stream Map completed based

on all data gathered and discoveredusing the process improvement methodology

METHODOLOGY (Cont.)

13. Prioritized all solutions14. Categorized the solutions for the approving authority.

METHODOLOGY (Cont.)

MAJOR FINDINGS

1. New adjunctive sponge and instrument counting technologies are not fully matured

2. Inadequate infrastructure in information technology to support, monitor and improve existing process

3. Current scheduling system does not support preparation of OR cases and patient safety

MAJOR FINDINGS (Cont.)

4. Need for surgical staff training in Crew Resource Management to ensure a safe working environment

5. Current policies for both medical staff & nursing have substantial gaps that result in poor adherence and practice

6. Excessive instruments and disposables are delivered to the OR in a manner that adds to distractions and impairs patient safety

PROCESS DEVELOPMENTInstitutional Policy Volume IV, Book B, Compliance Program, Ch. 4, Policy &Procedure Development & Review,

Policy IV.B.4.01

Policy, practice & compliance efforts in the OR and PE must be generated in a coordinated manner.

Must include all stakeholders:

•Nursing•Anesthesiology•Surgery•PE Support Services

PROCESS DEVELOPMENT CONT’D

• Generation of policies or improvement efforts without input from all stakeholdersreduces patient safety & contributes to anunsafe environment & culture.

• This policy compliance will be required as we begin to address the solutions proposed in this report.

• Operating Room policy should not be generated in a single discipline only.

PROCESS FOR SELECTING SOLUTIONS

• All solutions considered

• Determined pros and cons

• Prioritized

• Categorized

• Recommendation

SOLUTION FOCUS

1.1. Patient SafetyPatient Safety

2.2. Use of crew resource management principles for Use of crew resource management principles for safety in the ORsafety in the OR

3.3. Use of technology to support a defined process of Use of technology to support a defined process of counting by OR personnel for sponges and counting by OR personnel for sponges and instrumentsinstruments

4.4. Fostering a collegial working relationship among Fostering a collegial working relationship among those involved in the ORthose involved in the OR

5.5. Develop IT systems to support continuous Develop IT systems to support continuous performance, quality and safety improvementperformance, quality and safety improvement

6.6. Close gaps between existing policies, improve Close gaps between existing policies, improve compliance to policy, and competency assessmentcompliance to policy, and competency assessment

RECOMMENDED PROCESS (1 of 4)

Surgeon must provide documentation with

reason.

Check Preference Card & Verify Against

Schedule and patient consents

Is it a Single Service?

Yes

No

Open Sterile Supplies as needed

Are there sufficient supplies?

Yes

No

A

Open Instrument Set (s)

Talk to ManagerIs manager able

to resolve?

Discuss issues with Surgeon

Surgeon cancels surgery Does Surgery proceed?

Surgery Preparation Proceeds

Are there sufficient

instruments?

Notify Sterile Processing and request instruments

Is additional help or tables needed?

Are additional instruments required?

Yes

Yes

YesYes

Yes

No

No

No

No

No

Supplies

Instruments

Sub Process

Instrument sets are delivered to Main OR

or ACB.

Request supply technician to obtain.

Deliver to OR

Are instruments available?

Yes

No

No

Have Sterile Supply bring to

OR

1

2

3

4

56

11

12

18

1716

15

13

14

8

719

20

22

Are instruments

sterile?

21

10 23

24

2526 9

Decision to schedule surgery is made in clinic

& signed off by surgeon

Correct procedure is posted and correct preference card is

generated.

Surgeon verifies with Nurse Manager (24 hrs

in advance) that posting is correct.

Account and document for all supplies presented to sterile field (incl. non-

pre-qualified)¹

Autoclave and sterilize

instrument

Yes

[Go to “A” on Page 2]

1Note potential for electronic web board technology & potential for electronic sponge & lap counts

A

Scrub person arranges instruments & supplies on back table (s) based

on standardized, consistent setup on back table according to POE

policy.

Supplies

Instruments

Sub Process

No Count Necessary

BDoes this

procedure require a count (per

Policy)?

YES

NO

27 28 29

30

31

32 33

Begin standardized counting methodology

per OR Policy sub process (under development)¹

Document on a standardized counting

sheet¹

[Go to “B” on Page 3]

Continue with counting methodology per sub

process [UNDER

DEVELOPMENT]

Assembly sheet tray is passed on to circulating

nurse

1 Note potential for electronic web board technology and potential for

electronic sponge & lap counts

RECOMMENDED PROCESS (2 of 4)

C

D

Surgeon must provide documentation with

reason.

Is there a change in personnel?

(circulators/ scrubs)

Standardized process & report for hand-off is

followed and validated by circulating nurse.

Are additional supplies/

instruments needed?

TIME OUT for closing count is initiated by

surgeon or designee

Surgeon & assistant check body cavity for

potential RFO

Instrumentation and supplies not utilized for closing are returned to appropriate place for

count

Sponge & miscellaneous supply counts completed per standardized policy (excluding instruments)

Are all non-instruments

accounted for?

Proceed to instrument count

Second attempt is made to locate potential RFO in

body cavity

Has the foreign object been

found?

Request radiology services

Is X-ray adequate?

Communicated between all radiology and surgical

faculty

Is foreign object found?

NO

YES

NO

YES

NO

YES

NO

YES

NO YES

NOYES

34

35

36

37

49

47

67

48

39

Procedure begins

Begin standardized methodology for communicating

counts during personnel changes per sub process

[UNDER DEVELOPMENT]

Instruments added to count sheet & initialed by

person adding

41

Instruments and supplies required for closing are added to white board

42

43

4445

Surgery temporarily suspended

50 4651

52

X-ray taken per radiology sub process

53

5455

56

C Document and complete necessary reports

58

57

Begin standardized counting system for instruments when all

body cavities are closed per sub-process

[UNDER DEVELOPMENT]

Are all instruments

accounted for?

59

NO

YES

D

Document terminal instrument count

60

Complete terminal sponge and supply count

6162NO

YES

E

E

Process completed Is count correct?Does surgeon want

to continue searching?

NO

YES

63

TBD

65

Surgeon decides where to re-enter process

64

66B

65

Procedure continues

Supplies added to white board & initialed by

person adding

40

Process completed

Supplies

Instruments

Sub Process

See x-ray sub process on page 4

Was patient packed with laps

intentionally?

NO

YES

Documents on grease board & Nursing intraop

record (type/amount/removed/not at case

end)

Notify surgeon of item packed and/or removed

at case completion

38

68 69

Upon removal of packing, x-ray mandatory

post removal packing intraoperatively

68A

Go to x-ray sub-process #53

RECOMMENDED PROCESS (3 of 4)

OR calls DI hotline with RFO request

DI hotline notifies technologist and faculty

radiologist

Technologist cross checks with surgeon and

anesthesiologist to establish patient ID

53.2

X-ray taken per radiology sub process

53 53.353.4

53.1 The surgeon establishes a field free of unnecessary objects and

in collaboration with technologist ensures the

appropriate field is captured on x-rays (AP Views)

Images are transferred to Rad Station and Clinic

Station

The radiologist interprets the x-ray and calls the OR hotline

Surgeon receiving the report reads back report received

53.5 53.6

Radiologist is connected to the OR and provides a

standardized report to the surgeon.

53.7

53.8

See 54 on page 3

RECOMMENDED PROCESS (4 of 4)

RECOMMENDED SOLUTIONS

1.1. Adopt the new counting process developed by Adopt the new counting process developed by the RFO Team (Appendix M) that governs the the RFO Team (Appendix M) that governs the counting process and RFOscounting process and RFOs

2. Develop a comprehensive, competency based 2. Develop a comprehensive, competency based training program for the Perioperative training program for the Perioperative Enterprise to include surgeons, PAs, Enterprise to include surgeons, PAs, anesthesiologists, nursing, assistants, techs, anesthesiologists, nursing, assistants, techs, and radiologists as it relates to countingand radiologists as it relates to counting

RECOMMENDED SOLUTIONS

3. Circulating nurse should not be interrupted to do 3. Circulating nurse should not be interrupted to do additional tasks:additional tasks:A. Provide adequate support staff in OR to A. Provide adequate support staff in OR to eliminate disruptions during count eliminate disruptions during count B. Emphasize accuracy in B. Emphasize accuracy in preference card, schedule and patient consentspreference card, schedule and patient consentsC. Consider OR communication options that will C. Consider OR communication options that will reduce distraction and obtain Executive Team reduce distraction and obtain Executive Team support (export to ACB)support (export to ACB)

44. . Charter an Implementation Team to implement the Charter an Implementation Team to implement the recommendations of the Team that have been recommendations of the Team that have been vetted through the OR Committee and approved vetted through the OR Committee and approved by the OR Executive Teamby the OR Executive Team

RECOMMENDED SOLUTIONS

5A. Establish an Oversight Team to consider 5A. Establish an Oversight Team to consider recommendations, make modifications and perform a recommendations, make modifications and perform a semi-annual review of the counting processsemi-annual review of the counting process and RFORFO preventionprevention

5B. Continue instrument reduction efforts5B. Continue instrument reduction efforts

7A. Develop a standardized nomenclature of all 7A. Develop a standardized nomenclature of all instruments and disposals across the count sheet, instruments and disposals across the count sheet, Perioperative Enterprises training and radiology libraryPerioperative Enterprises training and radiology library

7B. There must be an on-going assessment, 7B. There must be an on-going assessment, evaluations and enforcement of the counting policyevaluations and enforcement of the counting policy

9. Attending surgeon will be notified of first incorrect 9. Attending surgeon will be notified of first incorrect count per new processcount per new process

RECOMMENDED SOLUTIONS

10. Institute Crew Resource Management training for 10. Institute Crew Resource Management training for all OR personnelall OR personnel

11. Only faculty radiologist will read x-rays with regards 11. Only faculty radiologist will read x-rays with regards to retained foreign objects, including after normal duty to retained foreign objects, including after normal duty hours. A test for an RFO should be considered a critical hours. A test for an RFO should be considered a critical test. test.

12. Develop a policy that lists all procedures where 12. Develop a policy that lists all procedures where counts must be done. The policy will be vetted with the counts must be done. The policy will be vetted with the OR Committee & Surgical Chairs prior to sending to OR Committee & Surgical Chairs prior to sending to OR Executive Team OR Executive Team

13A. Develop a standardized nomenclature of 13A. Develop a standardized nomenclature of operative procedures that ties in with the Scheduling operative procedures that ties in with the Scheduling Performance Improvement Team recommendations Performance Improvement Team recommendations

RECOMMENDED SOLUTIONS

13B. Eliminate the occurrence of intimidations by 13B. Eliminate the occurrence of intimidations by surgeons, by enforcing the OR Behavior Policy surgeons, by enforcing the OR Behavior Policy approved by the Medical Practice Committeeapproved by the Medical Practice Committee

15A. Needles, guide wires, and blades will be 15A. Needles, guide wires, and blades will be counted using ACB OR as “best practice” sitecounted using ACB OR as “best practice” site

15B. The counting sub-process will be standard for 15B. The counting sub-process will be standard for both the ACB and the Main OR both the ACB and the Main OR

17A. Retained Foreign Object is17A. Retained Foreign Object is defined as when the defined as when the patient is re-anesthetized and/or taken back to the patient is re-anesthetized and/or taken back to the OR to remove the RFO. A "NearOR to remove the RFO. A "Near Miss" is anyMiss" is any miscount in the OR that is reconciled in the OR. miscount in the OR that is reconciled in the OR.

RECOMMENDED SOLUTIONS

17B. Establish a standard policy of notification after 17B. Establish a standard policy of notification after film is read as mapped in the radiology sub processfilm is read as mapped in the radiology sub process

19. Adopt the standardized system on how 19. Adopt the standardized system on how instruments and supplies are arranged on back table instruments and supplies are arranged on back table

20. Create radiology library of foreign body 20. Create radiology library of foreign body instruments (materials)instruments (materials)

21A. Use standardized whiteboard to improve 21A. Use standardized whiteboard to improve communications in the OR (consider electronic communications in the OR (consider electronic whiteboard) whiteboard)

RECOMMENDED SOLUTIONS

21B. An incorrect count report has been implemented 21B. An incorrect count report has been implemented by nursing in the electronic medical record and should by nursing in the electronic medical record and should be part of the OR medical record and transparent for be part of the OR medical record and transparent for continuous quality improvementcontinuous quality improvement

23. Consider trial evaluation of Clear Count's system 23. Consider trial evaluation of Clear Count's system with wand to augment the counting processwith wand to augment the counting process

24. Attempt to keep surgeon and nurses together as 24. Attempt to keep surgeon and nurses together as a team when possible a team when possible

25. Eliminate cut items to the greatest extent 25. Eliminate cut items to the greatest extent possible. Look at smaller types of items that could be possible. Look at smaller types of items that could be substituted. If an item is cut, exceptional care must be substituted. If an item is cut, exceptional care must be taken to reconstruct during counttaken to reconstruct during count

RECOMMENDED SOLUTIONS

26. Anesthesia should be responsible and 26. Anesthesia should be responsible and accountable for their gauze sponges and accountable for their gauze sponges and instruments. There should be no cross use instruments. There should be no cross use between surgical and anesthesia team. This will between surgical and anesthesia team. This will require an anesthesia policy supported with require an anesthesia policy supported with education.education.

27. Surgeon or designee documents their 27. Surgeon or designee documents their understanding that all count results are correct or understanding that all count results are correct or incorrect in the operative reportincorrect in the operative report

28. Surgeons should be included in nursing 28. Surgeons should be included in nursing competencies evaluationcompetencies evaluation

RECOMMENDED SOLUTIONS

29. The Director for the Perioperative Enterprise 29. The Director for the Perioperative Enterprise Support Team will determine how to best Support Team will determine how to best document and track case cart shortages and their document and track case cart shortages and their reconciliationreconciliation

30. All instruments except "retractors" will be out 30. All instruments except "retractors" will be out of trayof tray

SOLUTION CATEGORIZATION 1 2 3 4 5 6 7

Prioritized SolutionRequired for

P atient Safety

Can be accomplished

in-house (P OE)Requires IT Involvement

Must have to

succeed

Quick &/or easy to

implement

P otential Resistence to

ChangeGood Return

on Efforts

1 A Adopt the new counting process developed by the RFO Team (Appendix M) that governs counting process and RFOs X X X X X

2 GDevelop a comprehensive, competency based training program for the Perioperative Enterprise to include surgeons, PAs, anesthesiologists, nursing, assistants, techs, and radiologists as it relates to counting. X X X X X X

3 S

Circulating nurse should not be interrupted to do additional task; 1. Provide adequate support staff in OR to eliminate disruptions during count; 2. Emphasis of accuracy in action #5 of the process; 3. Utilize new OR Communication Center & obtain Executive support & export to ACB X X X X X

4 BCharter an Implementation Team to implement the recommendations of the Team that have been vetted through the OR Committee and approved by the OR Executive Team X X X X

5 CCEstablish an Oversight Team to consider recommendations, make modif ications and perform a semi-annual review of the counting process X X X X X

5 DD Continue instrument reduction efforts X X X X X X

6 RDevelop a standardized nomenclature of all instruments; include in f ilm library “an outgrow th” of the standardized nursing count sheet X X X X X X

6 V There must be an on-going assessment, evaluations and enforcement of the counting policy X X X X X X8 J Attending surgeon w ill be notif ied of 1st incorrect count per new process, actions #44 & #59 X X X X X X X9 H Institute crew training for all OR personnel. X X X X X

10 DOnly Faculty Radiologist w ill read x-rays w ith regards to retained foreign objects including after normal duty hours. A test for an RFO should be considered a critical test. X X X X X X

11 UDevelop a policy that lists all procedures w here counts must be done. The policy w ill be vetted w ith the OR Committee & Surgical Chairs prior to sending to OR Executive Team X X X X X X

12 N Develop a standardized nomenclature of operative procedures that ties in w ith the SPIT recommended process X X X X X X

12 WEliminate the occurrence of intimidations by surgeons by enforcing the OR Behavior Policy currently at medical Practice Committee for approval X X X X X

14 X Needles, guide w ires, and blades w ill be counted and ACB should be used as the best practice site X X X X X X14 BB The counting sub process items #58 and #31 w ill be standard for both the ACB and the Main OR X X X X X

16 ERetained Foreign Object (RFO) is defined as w hen the patient is re-anesthetized and/or taken back to the OR to remove the RFO. A "Near Miss" is any miscount in the OR that is reconciled in the OR X X X X X X X

16 L Establish standard policy of notif ication after f ilm is read as mapped in the radiology sub process, actions #53.1 thru #53.8 X X X X X

17 P Adopt standardized system now being developed by nursing on how instruments and supplies are arranged on back table X X X X X18 C Create f ilm library of foreign body instruments (materials) that w ould be available to all surgeons X X X X X19 K Use standardized w hiteboard to improve communications in the OR (consider electronic w hiteboard) X X X X X X

19 AAAn incorrect count report has been implemented by nursing in the electronic medical record and should be part of the OR medical record and transparent for CQI X X X X X X

21 M Consider using Clear Count's system w ith w and to augment the counting process, see Appendix H X X X X X X22 I Attempt to keep surgeon & nurses together as a team w hen foreseeable X X

23 ZEliminate cut items to the greatest extent possible. Look at smaller type items that could be substituted. If an item is cut, exceptional care must be taken to reconstruct during count X X X X X X

24 YAnesthesia should be responsible and accountable for their laps & instruments. There should be no cross use betw een surgical team and anesthesia team. This w ill require and anesthesia policy follow ed w ith education X X X X X X

25 F Surgeon signs or designates someone to sign OR Report that counts are correct, action #60 X X X X X X26 O Surgeons should be included in nursing competencies valuation X X

27 QThe Director of the POE Support Team w ill take the action on how to best document OR instruments and supply shortages & supplementations X X X X X

30 T All instruments except "retractors" w ill be out of tray X X X X X

• Necessity

• Recommended Team

• Will require a disciplined approach in engineering organizational change

IMPLEMENTATION TEAM

RECOMMENDED IPT

Greg Reece, MDProcess Improvement

Program Manager

TBDCommunication

Manager

RFO IPT

Project Manager

Stephanie RamirezScheduling IPTProject Manager

Melina ScarboroughAssistant Program

Manager

TBDImplementation/

Change Agent Advisor

IPT Team LeaderSurgeon

Nursing ACB Manager

Clinical Nurse Main OR

Nursing Main OR

Clinical Nurse ACB

Surg Tech Main OR

Surg Tech ACB

Surgeon Quad 1

Surgeon Quad 2

Surgeon Quad 3

Surgeon Quad 4

Radiology Supervisor

Radiologist

IT

PI

Communications Specialist

Recorder/Coordinator

Facilitator

Sterile Processing

Materials Management

QI Statistician

Representative from Intellectual

Property

SME on Crew

Resource Management

Anesthesiologist

• OR Committee reviews the Team’s recommended solutions and if it does not agree, add its addendum to the final report

• OR Executive Team accepts and approves the final report

• Charter the Implementation Planning Team (IPT)

• Continued support to the IPT

REQUEST THE FOLLOWING::

DISCUSSION