Didactic: Falling Off a Horse Named “Surgical Misadventures ...How Do You Get Back in the Saddle?...

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Didactic: Falling Off a Horse Named “Surgical Misadventures”:

How Do You Get Back in the Saddle?

PROGRAM CHAIR

David I. Eisenstein, MD

PROGRAM CHAIR

Louise P. King, MD

Marisa Dahlman, MDRajiv Gala, MD

Maggie M. Finkelstein, JDMatthew M. Palmer, MD

GLOBAL CONGRESSON MINIMALLY INVASIVE GYNECOLOGYNOV. 17-21, 2014 | Vancouver, British Columbia

43rd AAGL

Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 3 Overview: Getting Back on Your Horse Is First Knowing Your Horse D.I. Eisenstein ................................................................................................................................................ 4 Professional and Personal Impact R. Gala ......................................................................................................................................................... 10 Introduction to Legal Principles and Ramifications of Maloccurrence M.M. Finkelstein ......................................................................................................................................... 16 GI Injury M.M. Palmer ............................................................................................................................................... 22 GU Injuries M. Dahlman ................................................................................................................................................. 26 Safety in Electro‐Surgery: A Brief Primer L.P. King ....................................................................................................................................................... 31 Cultural and Linguistics Competency ......................................................................................................... 40

LGL-‐712 Didactic: Falling Off a Horse Named “Surgical Misadventures”:


David I. Eisenstein, Chair Louise P. King, Co-‐Chair

Faculty: Marisa Dahlman, Maggie M. Finkelstein, Rajiv B. Gala, Matthew M. Palmer

This course provides a detailed and prescriptive dialectic on typical complications encountered in minimally invasive gynecologic laparoscopic surgery. In addition to presenting skills to prevent complications and managing them when they befall us, the course material delves into the pertinent medico-‐legal strategies implied by the area considered, and surveys the professional and personal impact of maloccurrences and how to survive them. Course material covers a range of clinical scenarios including position-‐related injury, abdominal access, electro-‐surgery, and genito-‐urinary and gastro-‐intestinal events. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Define pre-‐surgical strategies to minimize and prevent surgical maloccurrence; 2) apply anatomic knowledge and technical skill to dissect, protect and repair GU and GI structures; and 3) develop strategies to manage the professional impact of surgical maloccurrence.

Course Outline 12:30 Welcome, Introductions and Course Overview D.I. Eisenstein

12:35 Overview: Getting Back on Your Horse Is First Knowing Your Horse D.I. Eisenstein

12:50 Professional and Personal Impact R.B. Gala

1:20 Introduction to Legal Principles and Ramifications of Maloccurrence M.M. Finkelstein

1:40 Safe Laparoscopic Entry, Safe Laparoscopic Positioning L.P. King • Safe Positioning and Avoiding Nerve Injury • Abdominal Access and Risk Veress vs. Direct Entry; High Pressure GI and Vascular Injuries: Avoidance, Identification, and Repair • Checklist/Protocol for Emergencies • Case Presentation

2:10 GI Injury D.I. Eisenstein, M.M. Palmer • Occurrence and Risk Factors • Safe Dissection Techniques Sharp Dissection Techniques / Electro-‐Surgery • Repair of Bowel Injury

• Case Presentation

Page 1

2:40 Questions & Answers All Faculty

2:50 Break

3:05 GU Injuries D.I. Eisenstein, M. Dahlman • Anatomy: Para Rectal and Para Vesicle Spaces • The “Difficult” Bladder: Strategies and Techniques • Cystoscopy: Role and Evidence • Ureter: Protection and Repair When Is Ureterolyisis Necessary? Role of Stents • Case Presentation

3:35 Safety in Electro-‐Surgery: A Brief Primer L.P. King

3:55 Physician Self Care: Mindfulness in Management of Stress Faculty

4:20 Questions & Answers All Faculty

4:30 Adjourn

Page 2

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor* Kimberly A. Kho* Frank D. Loffer, Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathon Solnik* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: Blue Endo, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical William M. Burke* Rosanne M. Kho* Ted T.M. Lee Consultant: Ethicon Endo-‐Surgery Javier F. Magrina* Ceana H. Nezhat Consultant: Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Other: Stock Ownership: Titan Medical Robert K. Zurawin Consultant: Bayer Healthcare Corp., CONMED Corporation, Ethicon Endo-‐Surgery, Hologic, Intuitive Surgical FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Marisa Dahlman* David I. Eisenstein Speakers Bureau: Abbott Laboratories Louise P. King* Maggie M. Finkelstein* Rajiv Gala* Matthew M. Palmer Consultant: Intuitive Surgical Asterisk (*) denotes no financial relationships to disclose.

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Falling Off a Horse Named “Surgical Misadventures”:


David Eisenstein MD FACOGHenry Ford Health System

• Speakers Bureau: Abbott Laboratories

IVC INJURY: MP4

11/18/2014 LGL - 712 PG Course

BLADDER : WMV

11/18/2014 LGL - 712 PG Course

GI Injury MP4

11/18/2014 LGL - 712 PG Course

Ureteral Injury MP 4

11/18/2014 LGL - 712 PG Course

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Dealing with ComplicationsLam et al; Best Practice & Research; 200

• Definition of Complication as

“a new problem or illness that makes treatment of a previous one more complicated

or difficult’’

Complications at Laparoscopy 1987‐1995Chapron et al Human Reproduction 1998

• Rate 4.6/1000; 3.2/1000 requiring laparotomy

• Mortality 3.3/100,000 (N=1; vascular/arterial)

• Impact of surgical experience

– Decrease bowel injury (p = .0003)

– Decrease laparotomic management (p = .01)

11/18/2014 LGL - 712 PG Course

Complications by Type Total N≈30,000;

4.6/1000 Overall Complication Rate

Injury Type % Access Injury(%) Unrecognized(%) 10 year trend

Overall: 34.1% Overall: 28.6

GI 34.5 32.5 41.8% Decrease

GU 27.4 13.1 23.7% Stable

Vascular 32.4 37.4 20.0% Increase

Infectious 5.0

Chapron et al; 1998, Human Reproduction

11/18/2014 LGL - 712 PG Course

Complications at Laparoscopy 1987‐1995Chapron et al Human Reproduction 1998

N=30,000 case/9 centers

Procedure Type

Diagnostic Minor Major Advanced19% 19% 49% 11%

Rates of Complication (per 1000)

.84 4.3 17.4511/18/2014 LGL - 712 PG Course

Dealing with Complications: ACTLam et al; Best Practice & Research; 200

• A : Awareness

• C: Communications/Counseling

• T: Teamwork

Dealing with Complications: PhasesLam et al; Best Practice & Research; 2009

• Phase I – Patient identification

• Phase II – Anaesthesia and positioning

• Phase III – Abdominal entry and port placement– >50% injury; GI, GU, Vascular

• Phase IV – Surgery & Procedure – Related Events– Adhesiolysis=GI; TAH=GU; Myomectomy=hemorrhage

• Phase V – Postoperative recovery– GU and GI injury and late presentation

• Phase VI – Counseling

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GU injury Prevention at LH: ExpertsJansen, JMIG 2011

Consensus

• Education

– text/video; simulation

– Fellowship

– Learning Curve (Normal)

• Technique

– Uterine Manipulator

– Dissect Uterine aa / Coaptation perpendicular to cervix

– Restore Distorted Anatomy/Develop PV Space in certain scenarios

• Diagnosis

– Early Detection

Non‐Consensus

• Education

– Learning Curve (Abnormal)

• Technique

– Angled Lens

– Routine Ureterolysis

– Cystoscopy

– Routine Dissection techniques

• Diagnosis

– Any routine use of stents; dye; cystoscopy

11/18/2014 LGL - 712 PG Course

ACCESSABDOMINAL WALL ADHESIONS

AND PRIOR SURGERY

STUDY % / NO

SURGERY

% / LOWPF

% / LVM % / HVM % BOWEL INVOLVEMENT

BRILL ET AL 1995

NA 27 55 67 17‐40

LEVRANT1997

NA 28 59 ^^^ 27‐29

AUDERBERT2000

.68 19.8 51.7 ^^^ 31

DUBUISSON 2010

.28 13 67 100 33‐50

PF = PFANNENSTIEL; LVM = LOW VERTICAL; HVM =VERTICAL ABOVE UMBILICUS

Scheib et alJMIG 2014

Injury Prevention :Anatomic Spaces

11/18/2014 LGL - 712 PG Course

Adverse Events: Impact on PhysiciansPeri Operative Death in Anesthesia

Gazoni et Anesth Analg 2012

• >70% experienced guilt, anxiety, reliving event

• 88% required time to “emotional recovery from 1 Day(12%) to Never recovered (19%); 12% considered Career change

• 68% supported mandatory debriefing/75% offering time off

– Debriefing ass with blame/fear of litigation/personally responsible‐depressed

Impact of Adverse Events on OB/GynSurvey Data: Perinatal Death

• Demographics– 804/1500 Surveys: 50% male/female; 46 Y.O.

• Impact– 75% admitted to “large emotional toll”

– 8% considered “giving up practice”

• Coping– 53% “adequately trained” in coping skills

• Statistically significant decrease in guilt and personal responsibility

• Method of Coping: – 87% informally with colleagues;58% friends and family; 47% case review

Gold et al OG 2008

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Gynecologists and Adverse EventsACOG survey

• 9006/32,238 completed surveys

• Age 50.7; 19.8% Gyn only; 3.4 TAH/mo.

• 1496 GYN claims; 44.4% “surgical complications; 28.7% TAH, 14.6% Laparoscopic– 29.1% Patient injury‐major

– 22.1% Delayed/Failure Dx

– 20.7% Patient injury‐minor

Overview of the 2012 ACOG Survey on Professional Liability By Jeffrey Klagholz, BS, and Albert L. Strunk, JD, MD, FACOGhttp://www.acog.org/About-ACOG/ACOG-Departments/Professional-Liability/2012-Survey-Results


• 12.4%decreased volume procedures

• 5.2% stopped performing procedures

• 1.4% stopped performing surgery

• 16% report >10% drop in income; 2.3% relocated

Practice Changes Due to Cost of Insurance



• 18.9% decreased surgical procedures

• 6.7% stopped major procedures

• 1.4% stopped performing surgery

• 12.3% changed to employment model; 3.6% relocated

Practice Changes Due to Liability Fears


At the conclusion of this course, the clinician will be able to:

– 1) Define pre‐surgical strategies to minimize and prevent surgical maloccurrence;

– 2) apply anatomic knowledge and technical skill to dissect, protect and repair GU and GI structures; and

– 3) develop strategies to manage the professional impact of surgical maloccurrence

How to Get Back in the Saddle? How to Get Back in the Saddle?

Page 7



• Brill A, Nezhat F, Nezhat C, Nezhat C: The Incidence of Adhesions After Prior Laparotomy: A Laparoscopic Appraisal; Obstet Gynecol 1995;85:269‐72

• Audebert, A, Gomel, V:Role of Micro laparoscopy in the Diagnosis of Peritoneal and Visceral Adhesions and in the Prevention of Bowel Injury Associated with Blind Trocar Insertion; Fertility and Sterility 2000;73:631‐35

• Dubuisson J, Botchortshvili R, Perrette S, Bourdei N, Jardon K, Rabischong B, Canis M, Mage G:Incidence of Intraabdominal Adhesions in a Continuous Series of 1000 Laparoscopic Procedures; Am J Obstet Gynecol 2010;203:111.e1‐5

• Lam A, Kaufman Y, Khong S, Liew A, Ford S, Condous G: Dealing with Complications in Laparoscopy; Best Practice & Research Clinical Obstetrics and Gynecology 2009:23;631‐46

• Chapron C, Querleu D, Bruhat M, Madelenat P, Fernandez H, Pierre F, Dubuisson J: Surgical Complications of Diagnostic and Operative Gynaecological Laparoscopy: A Series of 29,966 Cases; HR 1998;13:867‐872

• Chan J, Morrow J, Manetta A: Prevention of Ureteral Injuries in Gynecologic Surgery; Am J Obstet Gynecol 2003;188:1273‐7

• Visco A, Taber K, Weidner A, Barber M, Myers E: Cost‐Effectiveness of Universal Cystoscopy to Identify Ureteral Injury at Hysterectomy; Obstet Gynecol 2001;97:685‐92

• Vakili B, Chesson R, Kyle B, Shobeiri S, Echols K, Gist R, Zheng Y, Nolan T: The Incidence of Urinary Tract Injury During Hysterectomy: A Prospective analysis Based on Universal Cystoscopy; Am J Obstet Gynecol 2005;192:1599‐604

• Hasson H, Parker W: Prevention and Management of Urinary Tract Injury in Laparoscopic Surgery; JAAGL 1998;5:99‐112

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• Janssen PF, Brolmann H, Huirne J: Recommendations to Prevent Urinary Tract Injuries During Laparoscopic Hysterectomy: A Systematic Delphi Procedure Among Experts; J Min Inv Gynecol 2011;18:314‐21

• Frankman E, Wang L, Bunker C, Lowder J: Lower Urinary Tract Injury in Women in the United States, 1979‐2006; Am J Obstet Gynecol 2010;202:495.e1‐5

• Clarke‐Pearson D, Geller E; Complications of Hysterectomy; Obstet Gynecol 2013;121:654‐73

• Gazoni F, Amato P, Malik Z, Durieux M; The Impact of Perioperative Catastrophes on Anesthesiologists: Results of National Survey; Anesth Analg 2012;114:596‐603

• Levrant S, Bieber E, Barnes R: Anterior Abdominal Wall Adhesions after Laparotomy or Laparoscopy; J AAGL 1997;4:353‐6

• Shirk G, Johns A, Redwine D: Complications of Laparoscopic Surgery: How to Avoid them and How to Repair them; J Min Invas Surg 2006;13:352‐9

• Scheib S, Tanner E, Green I, Fader A: Laparoscopy in the Morbidly Obese: Physiologic Considerations and Surgical Techniques to Optimize Success; J Min Invas Gynecol 2014;21:182‐195

• Bhoyrul S, Vierra M, Nezhat C, Krummel T: Trocar Injuries in Laparoscopic Surgery; J Am Coll Surg 2001;192:677‐83

• Levy B, Traynor M: Complications of Laparoscopy; A Practical Manual of Laparoscopy: A Clinical Cookbook;2007:427‐43

• Nezhat C, Nezhat F, Nezhat C: Overview of Complications; Nezhat’s Operative Gynecologic Laparoscopy and Hysteroscopy; 2008:582‐608

• Gold K, Kuznia A, Hayward R: How Physicians Cope with Stillbirth or Neonatal Death: A national Survey of Obstetricians; Obstet Gynecol 2008;112:29‐34

• Adverse Events in Ob‐Gyn: Video and Resources; American College of Obstetricians and Gynecologists. http://www.acog.org/About%20ACOG/ACOG%20Departments/Professional%20Liability/Adverse%20Events.asp

Cognitive Review Question

Practices shown in the literature to improve management of complications include:

1. Practicing dissection in a box trainer

2. Learning to assemble a cystoscope

3. Accessing coping resources in your institution

4. Getting to know your anesthesiologist

5. All of the above

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Professional and Personal Impact

Rajiv B Gala, MD, FACOGAssociate Professor

Ochsner Health SystemNew Orleans, LA (USA)

I have no financial relationships to disclose

Disclosure

Appreciate the four different scopes of impact an

adverse event can have Be able to define a “second victim” and identify

circumstances that would evoke a second victim response

Describe the six stages of personal recovery Identify the three tiers of support necessary for

optimal personal/professional recovery

Objectives

Practicing General Obstetrician/Gynecologist at Ochsner Medical Center (New Orleans, LA)

Married to another Ob/Gyn Program Director – Ochsner Ob/Gyn Residency

ProgramACOG Executive Board – Young Physician at Large

(2014-2017) “Volunteered” to help with the Adverse Events in Ob-

Gyn Video

My Background

Have you ever experienced an adverse event?

Yes

No

Audience Response #1

Did an adverse event limit the scope of your practice?

Yes

No


Page 10

Does your institution have an official crisis

management team to help you deal with an adverse event?

Yes

No


Right before vacation….

Initial Responses

Patient Patient’s Family Personal Professional

Different Scopes of Impact

Psychological Irritable Anger, guilt, frustration

Cognitive Inability to concentrate Distracted

Physical Fatigued Headaches

My Initial Personal Impact

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Emotional Impact Personally responsible for the unexpected patient

outcome Felt as though I failed the patient Second guessed knowledge base Second guess clinical skills

My Initial Personal Impact

Wu et al (2000) “Second Victim” – Used to describe the health care

professionals who were traumatized by such events in a similar way as the patient – the ‘first victim’.

Scott et al (2009) Regardless of gender, professional type or years in the

profession, the adverse event was “a life-altering experience that left a permanent imprint on the individual”

“Second Victim”

High risk scenarios that can evoke a second victim

response Unexpected patient death Long-term care relationship with patient death Death in a young adult patient Preventable harm to patient Multiple patients with bad outcomes within a short

period of time within one clinical area Patient who “connects” to health care professional’s

own family

“Second Victim”

Continuation of clinical responsibilities Flashbacks Challenges upon your confidence “Sign of weakness” if you took a break Avoidance of similar situations

Professional Impact

Continuation of clinical responsibilities The Obstetrician-Gynecologist Workforce in the United

States: Facts, Figures, and Implications, 2011 Workforce is ageing Ob/Gyn is among the most stressful medical

specialties Litigation concerns is a major factor in the early

retirement of ob-gyn and in the shift to gynecology-only practices

Professional Impact

Continuation of clinical responsibilities Impact to medical team and individual members Residents Medical Students Nursing staff

Professional Impact

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Time to debrief Signs and symptoms of this emotional aftershock may

last a few days, few weeks, months, or longer Quality of existing support systems can impact the

speed and quality of the debrief period

Recovery Process for Providers


Scott, SD, et al. The natural history of recovery for the healthcare provider ‘‘second victim’’ after adverse patient events. Qual Saf Health Care, 2009;18;325-330.



Stage 1 – Chaos and Accident Response• Error realized• Get help• Team-training drills / simulation prepares you for

this



Stage 2 – Intrusive Reflections• Haunted re-enactment of the event• Re-evaluate scenario in detail• Self-isolation



Stage 3 – Restoring personal integrity• Managing gossip/grapevine• Regaining acceptance at work• Fear is prevalent



Stage 4 – Enduring the Inquisition• Respond to multiple “why’s” about the event• Interact with many different event responders• Realization of level of seriousness• Litigation concerns emerge

Page 13



Stage 5 – Obtaining Emotional First Aid• Avoid isolation• Seek personal/professional support



Stage 6 – Moving On• Dropping out: Feelings of inadequacy• Surviving: Persistent sadness, still have intrusive

thoughts• Thriving: Gain insight/perspective; advocate for

patient safety initiatives

Traditional environment “Blame/Shame” “M&M” “Whispering”

Ideal environment One-on-One Support Individual Support Institutional Support

Culture Change Needed

As the healer, you don’t have to have the answer Show compassion and help open the door to future

conversationCall someone who had a recent event Be patient and allow for silence

One-on-One Support

MITSS (Medically Induced Trauma Support

Services) www.mitss.org 1-888-36-MITSS

University of Missouri “ForYOU Team” Three tiered Intervention Model Tier 1 – Local support Tier 2 – Trained peer support Tier 3 – Established referral network (SW, psychologist,

employee assistance)

Individual Support

Internal culture of safetyOrganizational awareness Formation of a multi-disciplinary advisory group Leadership buy-in Risk management considerationsClear policies, procedures, and practices! Learning and improvement opportunities

Institutional Support

Page 14

Hope this empowers you to start a conversation How does your organization manage the aftermath of a

serious clinical adverse event? What internal resources do you have? Do you have a crisis management team? Is the organization aligned around transparency and

approach?

Ullström et al (2014) Impact on the healthcare professional was related to the

organization’s response. Most lacked support or received unstructured/unsystematic support. Made it more difficult to process the event and reach closure

Now what?

Respectful Management of Serious Clinical Adverse Events (2nd

Edition). IHI Innovation Series White Paper Three Objectives Encourage and help every organization to develop a clinical

crisis management plan before they need to use it Provide an approach to integrating this plan into the

organizational culture of quality and safety, with a particular focus on patient- and family-centered care and fair and just treatment for staff; and

Provide organizations a resource in the absence of a clinical crisis management plan

Now what?

Conway J, Federico F, Stewart K, Campbell M. Respectful Management of Serious

Clinical Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2011. (Available on www.IHI.org)

Rayburn, William F. The obstetrician/gynecologist workforce in the United States : facts, figures, and implications 2011 /


Ullström S, Andreen Sachs M, Hansson J, etal. Suffering in Silence: A Qualitative Study of Second Victims of Adverse Events. BMJ Qual Saf 2014; 23: 325–331

Wu, AW. Medical Error: the second victim. The doctor who makes the mistake needs help too. BMJ 2000;320:726–7.

References

Page 15

Introduction to Legal Principles and Ramifications of MalOccurrence

Maggie M. Finkelstein, Esq.

Shareholder, Stevens & Lee, PC

November 18, 2014

1

• A manager of OB Consult, LLC, and a shareholder in the Healthcare Litigation and Risk Management Group of the Stevens & Lee law firm, with a focus on helping physicians to enhance safety and reduce liability risk

• Develops risk reduction opportunities in the health care industry and has evaluated various specialty‐specific liability risk issues including those associated with obstetrics, bariatric surgery and gastroenterology; Co‐authored 50 claims OB study to evaluate drivers of liability risk

• Has worked with leading clinical content experts to create new web‐based quality dashboards as a diagnostic tool in obstetrics and gynecology and bariatric surgery

• Part of a team that has created new, specialty‐specific insurance programs with safety platforms, in specialty‐specific areas

• Project lead on significant quality and safety evaluations and peer review evaluations for academic medical centers, international medical centers, and community‐based hospitals

• Defends physicians and other health care providers in state board investigation; provides event management support to physicians and hospitals; and provides oversight of national defense counsel panels

• With Jim Saxton, Esq., co‐authors articles, book chapters, and books on loss control and risk management topics, including patient experience, disclosure ‐ post‐adverse event communication, and liability risk reduction

• Former federal law clerk to the Honorable William W. Caldwell, U.S. District Court for the Middle District of PA.

• A registered patent attorney with the U.S. Patent & Trademark Office

Maggie M. Finkelstein, Esq.

2

I have no financial relationships to disclose.

Today

• Introduction to Legal Principles• Update on Your Medico‐legal Environment• Some Clinical and Professional Liability Fixes

Goals: • Demystify medical malpractice principles so you can

enhance your attack on preventing and mitigating lawsuits • Understand the interplay of post‐ACA health care

environment with patient safety and liability risk• Provide you with some examples of how you can impact

liability frequency and severity in the changing medico‐legal landscape while also enhancing your economics

3

INTRODUCTION TO MEDICAL PROFESSIONAL LIABILITY LEGAL PRINCIPLES

4

5

Why is it Important to Understand What Constitutes Medical Malpractice?

• Change your liability equation– Understand what causes claims

– Understand what elements constitute liability

– Understand the clinical and professional liability risks

– Understand the early warning signs that can lead to a claim

– Know how you can reduce risk of claims

• And these strategies to reduce claims are the same strategies that can also help with your economics in the new environment

6

Page 16

And Reasons You Should Care• Reputational issues at stake

• These take up your time (away from patients and away from family)

• Stress

• And the avalanche effect…– State licensing implications– Loss of health payor contracts– State board investigations– Hospital credentialing / peer review– Medical professional liability insurance coverage

7

The Elements of a Standard Medical Malpractice Case

• Plaintiff must prove:– Negligence – Causation– Damages

• Negligence (standard of care and breach of the standard)– Physician fails to meet the applicable

standard of care– Requires expert testimony for plaintiff

to prove, generally• Causation

– That negligence is the causal link to the patient’s injury or damages

– Generally requires expert testimony, exception: Res ipsa loquitor

• Damages– The patient must have actually

incurred damages– The damages must have been caused

by the negligence– Cannot be speculative

8

ACA Standards as SOC?

Federal legislation introduced 4/2013 – HR 1473

GA Governor Signs HB 499 (4/2013)

9

Malpractice is not a “MalOccurrence”

• Malpractice is ‘negligence’ – Breach of the standard of

care

• Mal‐occurrence is an ‘adverse event’ or ‘bad outcome’– Maloccurrence is not

malpractice

• Malpractice is NOT what in retrospect an expert thinks would have made a difference– “In retrospect, I can see

the abnormality on the initial x‐ray, although it is subtle.”

• Malpractice is NOT what could have been done better from a QA point of view

10

More than 70% of claims are driven by events other than malpractice

11

• Often it is a “plus factor”

– Lack of effective communication and service lapses 1

– And/or a lack of true event management

1. Levinson, W., Roter, D.L., Mullooly, J.P., Dull, V.T., Frankel, R.M. “Physician-patient Communication: The Relationship with Malpractice Claims Among Primary Care Physicians and Surgeons.” JAMA. 1997;227;553-559; Hickson, G.B., Clayton, E.C., Githens, P.B., Sloan, F.A. “Factors that Prompted Families to File Malpractice Claims Following Perinatal Injury.” JAMA. 1992; 287:1359-1363; Hickson GB, Federspiel CF, Pichert JW, Miller CS, Gauld-Jaeger J, Bo P. “Patient Complaints and Malpractice Risk.” JAMA. 2002, Jun. 12; 287(22): 2951-7; See Huttington, B., Kuhn, N. “Communication Gaffes: A Root Cause of Malpractice Claims.” BUMC Proceedings. 2003; 16: 157-161. See also Woolf S.M., Luzel AJ, Dovey SM, Phillips RL. "A String of Mistakes. The Importance of Cascade Analysis in Describing, Counting, and Preventing Medical Errors." Annals of Family Medicine. Vol. 2, No. 4 (July/August 2004).

What are the “Plus Factors”?

• Phone calls not returned• Rude physicians and/or staff• Lack of disclosure • Ineffective hand offs• Failure to notify patient of

abnormal lab test• After hours telephone calls not

documented• Informed consent process• Lack of documentation• Lack of a strong physician‐patient

relationship

12

For Example:

• Detailed conversation on the phone: “No need to go to ED.” You decide no reason to document the call. I’m too busy, it will never turn into anything.

Page 17

13

What Are the Early Warning Signs?

• Surgical Complications• Less than desirable or surprising result

• Letter, Phone Call from a patient...or a lawyer

• Patient or family requests a meeting with the doctor

• Patient or family complaints• Medical records request• Patient states...”I’m have an appointment with my lawyer next week”!

Plus, It’s not the same environment ….and it continues to change

• ACA– Transparency

– Reimbursement tied to value

– Care collaboration\care delivery

– Consolidation

– Growth of “traditional” liability issues

– The patient experience

• Changes in patient expectations

• All impact liability

14

Major pressure on surgeons to demonstrate quality and effectiveness ‐ ‐ and to

simultaneously reduce the cost of health care

15

The Bottom Line• Midlevel supervision and

collaboration• Care collaboration• Patient Portals• Coordinated Electronic

Medical Record• Standard of Care

– Guidelines Used to Heighten the Standard of Care

– Guidelines Used as Evidence of Standard of Care

• Increased Transparency• Care Guidelines Based on

Economics

16

Creating New or Enhanced Liability Risks

• Failure to adequately supervise a PA

• Who’s in charge?• Clinical e‐communication

lapses• Guidelines used as evidence

of soc or heightened soc• Increased availability of

data to plaintiffs• Alleged care omissions b/c

of costs

Economics prominent in the equation Tension with patient expectations

impact risk?

• “Do I really need to order that test?”

• Economic discovery?

• Punitive damages?

1717

The “transition period” could see incremental increases in both frequency and severity.

For Example… And Remember the “Retrospecto-scope”

The goals:

Control costs Reduce overuse of tests and procedures

Support physician efforts to engage patients in effective decision‐making

• Will the guidelines be used against physicians?

• Or, can we improve defense of omission through guidelines?

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All of which may lead to Punitive Damages

• ACOG Guideline #5: “Don’t screen for ovarian cancer in asymptomatic women at average risk”• Because “there is only fair evidence that screening asymptomatic women” will detect ovarian cancer at an earlier stage than it can be detected in the absence of screening

…Then a patient files a claim alleging a delay in diagnosis due to failure to screen an asymptomatic woman and asserts punitive damage claim that physician acted “recklessly, wantonly, willfully, and intentionally” in failing to screen knowing there was some evidence demonstrating ovarian cancer could be detected at an earlier stage

19

• The organized Plaintiffs’ Bar is more organized than ever

• Leveraging technology

And the Plaintiff’s Bar is Organized

STEVENS & LEEHealth Care Litigation and Risk Management Group

20

• Leveraging national and local expertise

• The new “surgeon‐lawyer” at plaintiff firms

A Focus on “Pre‐Courtroom” Period

• We can (and are) defending cases differently and better

• Part 2 of the equation begins before a lawsuit is ever filed

• Using templates\checklists

• Enhancing patient experience and engagement

• Documenting the good care provided

• Addressing “transitional” risk

= Building the better, and appropriate, evidence to prevent claims , or derail claims

21

Decreasing Variance = Increasing Patient Safety

What We’ve Seen

– Inconsistencies in processes

– Variances in procedures

– Gaps in implementation

– Incomplete follow‐up

Dr. Paul Gluck• Past Chairman of National Patient Safety Foundation Board of Directors (2005‐2008), after serving as a member of its Board of Directors for 13 years

• Immediate past chair of ACOG’s new Council for Patient Safety in Women’s Healthcare

“Most errors are the result of flawed systems. Standardized approaches can reduce variability and improve system efficiency.”

22Haynes AB, et. al., “A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population,” The New England Journal of Medicine 360 (January 2009): 491‐499.

23

Laying the groundwork for a supportive environment

Using certain data to understand what really makes a difference

Do a few things at a time and do them well Patient Experience Double‐down on the gynecological

surgery patient experience

Drilling down on the areas of care that your patients really care about

Importantly, act on real time data

Can enhance CAHPS scores

24

And move to true patient engagement Making patients part of the treatment decision Patient engagement “apps” Next‐generation patient‐responsibility agreements

Page 19

Some Documents That Can Help

• Procedure‐specific informed consent– Educational– Relationship building– Sound documentation

• Patient history form– Patient engagement opportunity

• At‐risk letter– Documentation tool– Patient engagement tool

• Electronic Communication Policies– With patient sign off

26

Informed Consent• Use in pre‐event discussions

– Enhance education

– Document patient understanding

– Set patient expectations

• Then use it in post‐adverse event discussion

• Procedure –specific– Attestation

– Specific risks (including but not limited to)

– Witness attestation And use it every time.

See, Spath PL (Ed.) “Engaging with Patients as Safety Partners: A guide for reducing errors and improving satisfaction.” Chicago: Health Forum (2008).

Case Scenario• Patient with h/o pain, and prior surgery for adhesions. 4/21 Patient underwent

robotic excision of endometriosis, lysis of adhesions, and R uretal lysis at hospital A by physician A. No issues and patient discharged. 4/21 Patient called the physician office a few hours after discharge, reporting pain and constipation. Instructed by office to try an enema.4/22 Patient tried enema and it did not work. P/c to practice; message left for physician. No return call from physician. 4/23 p.m. Patient goes to ER of a different hospital, Hospital B. 4/23 Hospital B dx a bladder injury; and repaired it.

• Physician A does not have privileges at that hospital and is unaware of her admission. 4/25 Patient calls the practice to cancel her post‐op appointment, because she was still hospitalized. Patient then wrote a letter to the practice, why didn’t you identify the bladder injury…and why didn’t you call me back? No response to letter. Patient requests a copy of her op report, intra‐op photos, and path report from Physician A. Patient does not return for post‐op surgical visit. Patient sends an additional letter requesting physician A pay for her out of pocket expenses, pain and suffering, lost wages. No response to letter. Physician’s office visited by sheriff who serves a lawsuit…

27

Medico‐Legal Case Discussion ‐Allegations

Potential allegations…while it’s a known potential injury…

1. Lack of appropriate pre‐surgery work‐up

2. Negligent performance of surgery; and surgery should have been an open procedure

3. Mismanagement of post‐op care

4. Delay in diagnosis of a bladder injury

5. Lack of informed consent about bladder injury

28

“Plus” Factors and Prevention/ Mitigation

29

• Lack of sufficient documentation of procedure risks

• Recommendation of trying enema by office staff, without consulting physician A

• Failure of doctor to contact patient once known she was hospitalized at another facility

• Failure of doctor to acknowledge or respond to the patient’s letters

• Procedure‐specific informed consent form

• Office policy and procedure on who provides medical advice over the phone/ triage

• Don’t ignore the red flags

• Use of at‐risk letter to bring patient back on track when apptmt. Missed

• Following a true event management process w/ appropriate post‐adverse event communication

Today’s Take Home Points

• The same underlying issues that impact liability risk, also can impact your economics post‐ACA

• Litigation continues to evolve…you can impact it before you ever get to the courtroom

• Use evidence‐based safety and professional liability initiatives, persistently, to hit the trifecta:– Reduce clinical clusters– Reduce professional liability clusters– Enhance your economics

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References• Haynes AB, et. al., “A Surgical Safety Checklist to Reduce Morbidity and Mortality in a

Global Population,” The New England Journal of Medicine 360 (January 2009): 491‐499.

• Levinson, W., Roter, D.L., Mullooly, J.P., Dull, V.T., Frankel, R.M. “Physician‐patient Communication: The Relationship with Malpractice Claims Among Primary Care Physicians and Surgeons.” JAMA. 1997;227;553‐559;

• Hickson, G.B., Clayton, E.C., Githens, P.B., Sloan, F.A. “Factors that Prompted Families to File Malpractice Claims Following Perinatal Injury.” JAMA. 1992; 287:1359‐1363;

• Hickson GB, Federspiel CF, Pichert JW, Miller CS, Gauld‐Jaeger J, Bo P. “Patient Complaints and Malpractice Risk.” JAMA. 2002, Jun. 12; 287(22): 2951‐7;

• Huttington, B., Kuhn, N. “Communication Gaffes: A Root Cause of Malpractice Claims.” BUMC Proceedings. 2003; 16: 157‐161.

• Woolf S.M., Luzel AJ, Dovey SM, Phillips RL. "A String of Mistakes. The Importance of Cascade Analysis in Describing, Counting, and Preventing Medical Errors." Annals of Family Medicine. Vol. 2, No. 4 (July/August 2004).

• H.R. 1473 – Standard of Care Protection Act of 2013, 113th Congress (2013‐2014) (accessible at https://beta.congress.gov/bill/113th‐congress/house‐bill/1473/text).

• See, Spath PL (Ed.) “Engaging with Patients as Safety Partners: A guide for reducing errors and improving satisfaction.” Chicago: Health Forum (2008). 31

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AAGL 2014PG LGL‐ 712

Falling Off a Horse Named “Surgical Misadventures” – How Do You Get Back in the Saddle?

GI Injury

Matthew Palmer, D.O.

Oakdale OB/Gyn – Minneapolis, MN

Graduate Fellow in MIS Gynecology – Henry Ford Health System ‐ Detroit, MI

Consultant: Intuitive Surgical

• At the conclusion of the lecture attendees should be able to:

– Identify the risks factors and incidence for GI injury in laparoscopy

– Discuss safe dissection techniques

– Discuss techniques for repair of bowel injury

PG COURSE LGL 712

Etiology of Bowel Injury

• Up to 50% of injuries occur during entry phase:

• Veres needle and trocar insert

• Other types of injuries

– THERMAL

– direct, capacitative coupling or insulation failure

– MECHANICAL

– retractors, manipulation

– LATE

– Port site herniation (0.06‐1%)

– Anastomotic leakage (rate increases the lower the resection)

11/18/144

PG COURSE LGL 712

Bowel Injury

• May not be apparent for 4‐5 days post‐injury

• 30‐50% are recognized at the time of surgery

• Sm bowel avg. 4.5 days, Colon avg. 5.4 days

• Any symptoms of peritonitis (sharp abdominal pain, abdominal distention, vomiting) must be considered a bowel injury until proven otherwise!!

• Avoid wish fulfillment – i.e. don’t ignore signs of an injury and just hope it will go away.

11/18/145

PG COURSE LGL 712

Incidence

• Minor operative laparoscopy associated with 0.08% risk of bowel injury

• Major operative laparoscopy associated with 0.33%

• Mortality rate 3.6%

• Injuries decrease significantly with experience

• Delayed diagnosis remains major problem; up to 15%of injuries not diagnosed during laparoscopy; one in five cases of delayed diagnosis results in death.

11/18/146

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PG COURSE LGL 712

Audebert, et al.

• Rate of umbilical adhesions after surgery

– Group I: No prior surgery (n=469) 0.68%

– Group II: Prior laparoscopy (n=125) 1.6%

– Group III: Prior laparotomy with horizontal suprapubic incision (n=131) 19.8%

– Group IV: Prior laparotomy with mid‐line incision (n=89) 51.7%

• Rate of severe adhesions with risk of bowel injury– Grp I: 0.42%, Grp II: 0.8%, Grp. III: 6.87%, Grp. IV: 31.46%

11/18/147

PG COURSE LGL 712

Small Bowel Injury

• Labs– Bands – Leukocytes– C ‐ Reactive Protein

• > 100 MG/L

• Free air should be absorbed w/in 24 hrs• Obese women may not exhibit rebound tenderness

• No antibiotics/observation– Surgery!

11/18/148

PG COURSE LGL 712

How to Avoid

• Entry– Left upper quadrant entry at Palmer’s pt.– Direct visualized entry with clear trocar– Pre‐op ultrasound to detect anterior abdominal wall adhesions

– Micro‐laparoscopy ‐> 1.2mm camera– Open laparoscopic entry ‐> Hassan

– benefit in preventing vascular injury but not bowel

11/18/149

How to Avoid

• Dissection– SHARP dissection > energy use, avoid blunt dissection– Use monopolar energy judiciously

• 100 watt cutting current with very short bursts

– Traction/counter‐traction– Parallel to the axis of the viscus– Develop retroperitoneal dissection skill– Never cut blindly, always see your target– Understand anatomy and surgical planes well

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PG COURSE LGL 712

Mechanical Bowel Prep

• Decrease the volume of fecal contents in the colony, which thereby decreases the total colony count of bacteria. – emollients– osmolar agents– stimulants

• Despite the large pool of data supporting the omission of mechanical bowel preparations and changing guidelines, clinical practice has been slow to change.

• General surgery data – recommend against mechanical bowel preparation for the indication of

decreasing infectious complications related to bowel injury or resection.

• Antibiotic bowel preparation, however, has proven beneficial in colorectal surgery and can reasonably be employed in complicated gynecologic cases at high risk for bowel involvement.

11/18/1413

Fanning et al.

(1) Preoperative mechanical bowel preparation does not lower the risk of anastomotic leakage and infection.

(2) Elective postoperative nasogastric tube decompression increases postoperative pneumonia and does not decrease the incidence of other postoperative complications.

(3) Early feeding after major gynecologic surgery reduces hospital stay and does not increase (and may decrease) pneumonia and other postoperative complications.

(4) Early feeding, gum chewing, bowel stimulation, alvimopan, and ketorolac may decrease the incidence of postoperative ileus.

14

PG COURSE LGL 712

Repair

• Serosal injury– If underlying muscular and mucosal layers remain intact repair not necessary, suture increases future adhesions

– Mucosa disruption ‐> oversew seroasa with 4.0 silk

• Colotomy– Primary repair in 2 layers

– 3.0 Vicryl for mucosal approximation

– 4.0 silk for seromusclar layer (perpendicular to long axis of bowel)

11/18/1415

PG COURSE LGL 712

Repair

• Leak test (sigmoid)– Methylene blue with foley or air (bubbles) with Toomy/sigmoidoscope

• Call a general surgeon?– Open vs laparoscopic repair?

– Resection with primary re‐anastomosis

• Post‐op– NG not necessary for small repairs

– Advance diet starting with clear liquids per routine

– May D/C when good BS and passing flatus11/18/14

16

PG COURSE LGL 712

Conclusions

• Low incidence but high risk of mortality

• Delay in diagnosis is the main danger

• Incidence decreases with experience but risk is always there

• Laparoscopic re‐operation must be done by an experienced surgeon– Get to know your hospitals subspecialists well

• Informed consent should include possibility of conversion to an open procedure

11/18/1417

PG COURSE LGL 712

Case Study

• BM is a 38 y.o. woman with a history of chronic pelvic pain and endometriosis.

• Prior surgeries consisted of TAH, RSO and subsequent open LSO. Ongoing pain after years of recovery prompted a workup for ovarian remnant syndrome.

• Labs studies and imaging confirmed the presence of residual ovarian tissue on the left as well as a large pelvic fluid collection.

• 2011 ‐ Underwent successful laparoscopic adhesiolysis and resection of left ovarian tissue.

• 2013 ‐ Ongoing pain prompted additional labs and MRI of pelvis

11/18/1418

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Case Study

• 2013 ‐A second laparoscopy for adhesiolysis and exploration of right sidewall for removal of right ovarian remnant performed.

• extensive adhesions along line of Toldt at left pelvic sidewall

• inadvertent sigmoid enterotomy of 1.5 cm created and immediately recognized

• prior bowel prep in this patient facilitated a clean colon with no spillage of stool into abdomen

• tension‐free area created to facilitate repair

• 2 layer closure done laparoscopically using 3.0 vicryl on bowel mucosa and 3.0 silk on serosa

• general surgeon entered case post repair to inspect our closure and air leak test demonstrated air‐tight closure

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Case Study

• Post‐op fever and pain work‐up revealed a small pelvic abcess that was drained under CT guidance.

• Patient recovered well and experienced resolution of most of her pain.

21

Cohen, SL. The Role of Mechanical Bowel Preparation in Gynecologic Laparoscopy. Rev Obstet Gynecol. 2011;4(1):28-31.

Lajer H, Widecrantz S & Heisterberg L. Hernias in trocar ports after abdominal laparoscopy. A review. ActaObstet Gynecol Scand 1997; 76: 389–393.

Platell C, Barwood N, Dorfmann G et al. The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis 2007; 9(1): 71–79.

Lam A, Kaufman Y, Khong SY, Liew A, Ford S, Condous G. Dealing with complications in laparoscopy. Best Practice & Research Clinical Obstetrics and Gynaecology 23 (2009) 631–646.

Audebert AJ, Gomel V. Role of microlaparoscopy in the diagnosis of peritoneal and visceral adhesions and in the prevention of bowel injury associated with blind trocar insertion. Fertil Steril. 2000 Mar;73(3):631-5.

Brosens I, Gordon A, Campo R, Gordts S. Bowel injury in gynecologic laparoscopy. J Am Assoc GynecolLaparosc. 2003 Feb;10(1):9-13.

Fanning J, Valea FA. Perioperative bowel management for gynecologic surgery. Am J Obstet Gynecol. 2011 Oct;205(4):309-14.

van der Voort M, Heijnsdijk E. A. M. and Gouma D. J. Bowel injury as a complication of laparoscopy. British Journal of Surgery 2004; 91: 1253–1258.

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GU Injuries in MIGSMARISA DAHLMAN, MD MPH

VIRGINIA MASON MEDICAL CENTER

SEATTLE, WA


ObjectivesAt the conclusion of this program, the participant will be familiar with:

Incidence and presentation of GU injury in gynecologic laparoscopy

Anatomy of the ureter and retroperitoneal spaces

Strategies for preventing injury in high‐risk situations

Evidence surrounding routine use of cystoscopy and ureteral stents

Scope of the problemEstimated rate of GU injury: 1‐2% for all gynecologic procedures◦ 75% of these occur during hysterectomy, leading to ~5000 injuries/year

Nieboer

Historically estimates of GU injury were much higher for LSC than for open laparotomy◦ 1997 retrospective study: 1.3% risk of ureteral injury

◦ 2006 Cochrane review: OR for LSC v open 2.04 for bladder and 3.43 for ureteral injury

Harkki‐Siren, Johnson

Scope of the problemCochrane review in 2009 showed no difference in injury rate by route of hysterectomy

Nieboer

Recent review of 40 papers estimates rate of GU injury at 0.73% for LSC hysterectomy◦ Bladder 0.5‐0.66%, 80% identified intraoperatively

◦ Ureter 0.02‐0.4%, 14% identified intraoperativelyAdelman

Ureteral anatomyCrosses the pelvic brim at the bifurcation of the iliac vessels

Courses along the pelvic sidewall in the ovarian fossa

Enters the cardinal ligament complex just lateral to the uterosacral ligament

Runs beneath the uterine artery 0.5‐1.5cm from the cervix

Makes a sharp turn over the anterior vaginal fornix to enter the bladder at the trigone

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Ureteral vasculatureUreteral sheath is adherent to peritoneum

Ureter derives vessels from multiple sources

Stripping of sheath may result in ischemia, delayed ureteral necrosis, and perforation

Potential spaces in the pelvisParavesical: bounded laterally by obturator internus muscle, medially by the bladder, anteriorly by the pubic ramus, posteriorly by the cardinal ligament

Pararectal: bounded anteriorly by the cardinal ligament, medially by the ureter, laterally by the internal iliac

Sites of injuryBladder:◦ Dome

◦ Trigone

Ureter:◦ Pelvic brim near IP ligament

◦ Cardinal ligament complex near uterine artery

◦ Near uterosacral ligaments after plication or cuff closure

Risk factors for injuryPrior pelvic surgery (including Cesarean delivery)

Endometriosis

Pelvic adhesions

Malignancy

Enlarged uteri

Adnexal masses

Cervical or broad ligament fibroids

Intraop hemorrhage

Obesity

Concomitant prolapse or incontinence procedures

Surgeon inexperience

Chan, Manoucheri, Vakili, Clarke‐Pearson, Hasson

Up to 50% of all patients who sustain a GU injury have no known risk factors.

Chou

Mechanisms of injurySharp: trocar, dissector, stapler

Thermal: electrosurgery, laser

Crush: suture, retractor, clamp

Devascularization

Hasson

All but sharp injuries become apparent only days later after tissue necrosis occurs.

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How to repair?Bladder◦ Dome: delayed absorbable suture in 1 or 2 layers of interrupted or running stitches, watertight repair, Foley in place x1wk, prophylactic antibiotics

◦ Trigone: high risk of ureteral kinking or occlusion, recommend consultation with urology

Ureteral injuries◦ Partial transection: stenting usually sufficient

◦ Complete transection: repair varies based on location and mode of injury

◦ Urology should be involved unless the surgeon is highly experienced with such repairs

Lam

Presenting symptomsFever

Hematuria

Abdominal or flank pain (not necessarily ipsilateral)

Ileus

Fistula with involuntary leakage

Ascites (fluid will have high creatinine)

Clarke‐Pearson

For thermal or ischemic injury, symptoms may not present until 7‐10 days postoperatively.

Delayed recognitionBladder injuries are more likely to be noted during surgery◦ Up to 80% in some studies, though as low as 33% in others

Chan, Adelman

Most ureteral injuries not recognized intraoperatively◦ Reported rates range from 14‐30%

Chou, Adelman

Consequences include fistula, loss of renal function, secondary nephrectomy

Frequent cause of litigation

Lam

How to avoid injuries?2011 Delphi procedure: experts arriving at consensus via sequential questionnaires◦ Uterine manipulators to lateralize vascular pedicles

◦ Careful dissection of vascular pedicles

◦ Retroperitoneal dissection to restore normal anatomy

◦ Ensure adequate surgeon experience (case load, simulation, fellowship)Janssen

Techniques for difficult anatomyOther possible strategies suggested but not supported by the Delphi analysis◦ Back‐filling the bladder, +/‐ colored fluid

◦ Angled laparoscopes

◦ Routine retroperitoneal exploration and ureteral dissection

◦ Routine cystoscopy

◦ Ureteral stenting

Janssen

Role of universal cystoscopyRelatively cheap, easy, and little to no morbidity associated

Ferro

Can increase rate of intraop identification of injuries and thus reduce postop morbidity

Patel, Valiki

Cost‐effective if rates of ureteral injury are 1.5‐2% or higher

Visco

Not useful for non‐occlusive or thermal injuries

Dandolu

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Prophylactic stentingEvidence supports use in high‐risk procedures such as radical hysterectomy or in patients with very distorted anatomy

Schimpf

Associated with postop flank pain, hematuria (usually mild and transient)

Manoucheri

No benefit to universal use shown in one randomized trial and one retrospective analysis

Chou, Kuno

Lighted stents may be more useful in laparoscopy when tactile feedback is limited

Redan

Patient TM39yo woman with endometriosis and pelvic pain underwent robot‐assisted laparoscopic right salpingo‐oophorectomy, left salpingectomy, lysis of adhesions.

Intraoperatively, the right ovary was densely adherent to the pelvic sidewall. The ureter was identified transperitoneally several times during dissection of the ovary.

The pt went home from the PACU with no issues and did well initially.

TM, continuedPOD#12 pt called complaining of 7‐8/10 pain unresponsive to NSAIDs/narcotics

POD#13 presented to ED with severe diffuse pelvic pain accompanied by menses, no other symptoms; abdominal exam benign, WBC 11.1K, UA with trace blood; sent home from ED without gyn consultation

POD#14 pt called with worsening pain radiating to upper abdomen and L flank, was sent back to ED

TM, continuedPOD#14 seen in ED with worsening pain, abdomen distended, WBC 13.2K; CT showed rim‐enhancing mass in L adnexa, mild R hydronephrosis; US pelvis showed L simple ovarian cyst, small amt FF in pelvis, confirmed R hydro noted to be new since surgery

Given concern for overall clinical picture, pt admitted to the hospital for observation and antibiotics.

TM, continuedPOD#15/HD #1: Pain improved with narcotics only, worse with movement. Receiving doxycycline and metronidazole, WBC down to 10. CT IVP ordered given hydronephrosis.

CT IVP“There is an extralumenalcollection of contrast in the region of the distal right ureter with evidence of extravasation into the left lower pelvis. The contrast is streaming into the pouch of Douglas …. [T]here is contrast opacification of the right ureter distal to this level … indicating that this is likely a partial disruption ….”

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TM, continuedPOD#15/0: Pt taken to OR by urology, stent successfully placed cystoscopically.

POD#16/1: Pt discharged home with improved pain.

1wk later had Foley catheter removed, pain was almost completely resolved

6wks postop stent was removed, CT IVP confirmed complete resolution of ureteral injury

ReferencesAdelman MR, Bardsley TR, Sharp HT. Urinary tract injuries in laparoscopic hysterectomy: A systematic review. JMIG. 2014; 21: 558‐66.

Chan JK, Morrow J, Manetta A. Prevention of ureteral injuries in gynecologic surgery. Am J Obstet Gynecol. 2003;188:1273‐7.

Chou MT, Wang CJ, Lien RC. Prophylactic ureteral catheterization in gynecologic surgery: A 12‐year randomized trial in a community hospital. Int Urogyn J Pelvic Floor Dysfunct. 2009;20:689‐93.;

Clarke‐Pearson DL, Geller EJ. Complications of hysterectomy. Obstet Gynecol. 2013;121:654‐73.

Dandolu V, Mathai E, Chatwani A, et al. Accuracy of cystoscopy in the diagnosis of ureteral injury in benign gynecologic surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2003;14:427‐31.

Ferro A, Buck D, Gallup D. Intraoperative and postoperative morbidity associate with cystoscopy performed in patients undergoing gynecologic surgery. Am J Obstet Gynecol. 2003;189:354‐7.

Harkki‐Siren P, Sjoberg J, Makinen J , et al. Finnish national register of laparoscopic hysterectomies: A review and complications of 1165 operations. Am J Obstet Gynecol. 1997;176:118‐22.

Hasson HM, Parker WH. Prevention and management of urinary tract injury in laparoscopic surgery. J Am Asoc GynecolLaparoscopists. 1998;5:98‐112.

Janssen PF, BrolmannHAM, Huirne JAF. Recommendations to prevent urinary tract injuries during laparoscopic hysterectomy: A systematic Delphi procedure among experts. JMIG. 2011;3:314‐21.

ReferencesJohnson N, Barlow D, Lethaby A, et al. Surgical approach to hysterectomy for benign gynecological disease. Cochrane Database Syst Rev. 2006;19. CD003677.

Kuno K, Menzin A, Kauder HH, et al. Prophylactic ureteral catheterization in gynecologic surgery. Urology. 1998;52:1004‐8.

Lam A, Kaufman Y, Khong SU et al. Dealing with complications in laparoscopy. Best Prat Rsrch Clin Obstet Gynaecol.2009;23:631‐46.

Manoucheri E, Cohen SL, Sandberg EM, et al. Ureteral injury in laparoscopic gynecologic surgery. Rev Obstet Gynecol.2012;4:106‐11.

Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;3. CD003677.

Patel H, Bhatia N. Universal cystoscopy for timely detection f urinary tract injuries during pelvic surgery. Curr Opin ObstetGynecol. 2009;21:415‐8.

Redan JA, McCarus SD. Protect the ureters. JSLS. 2009;13:139‐41.

Schimpf MO, Gottenger EE, Wagner JR. Universal ureteral stent placement at hysterectomy to identify ureteral injury: A decision analysis. BJOG. 2008;115:1151‐8.

Vakili B, Chesson RR, Kyle BL, et al. The incidence of urinary tract injury during hysterectomy: A prospective analysis based on universal cystoscopy. AJOG. 2005;192:1599‐604.

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Safe Laparoscopic Access

• Louise P. King MD JD• Beth Israel Deaconess Medical Center

• Department of Obstetrics and Gynecology• Division of Minimally Invasive Gynecology

• Harvard Medical School• Institute for Bioethics

Disclosure


Overview

• Patient Safety• Ethical Framework

• History

• Safe Laparoscopic Access• Potential Complications

• Cochrane Reviews

• Safe Access

Overview


• History



• Safe Access

Ethical Framework• Autonomy

• Voluntas aegroti suprema lex• Right to self-determination

• Beneficence• Salus aegroti suprema lex• Best interest of the patient• Concept of “healing” and doing good

• Non-maleficence• Primum non nocere• First do no harm

• Double effect – combined effect of a balance between beneficience and non-maleficence

• Justice• Fairness and equality in the distribution of scarce resources







Page 31







Overview


• History



• Safe Access

Harvard Medical Practice Study

• Brennan et al NEJM 1991 Feb 7;324(6):370-6• Prompted by increase in malpractice claims and payouts• Previous estimate inaccurate; based on voluntary reporting

• 30,121 randomly selected records from 51 randomly selected acute care non-psych hospitals reviewed

• “Adverse events” in 3.7 % hospitalizations• 27.6% due to “negligence”

– Including 6895 deaths and 877 cases of permanent and total disability

• 70.5% resulted in disability lasting < 6 months• 2.6% resulted in permanently disabling injuries• 13.6% resulted in death

– Many of these patients had severe underlying disease

“Adverse Events”

• How to define?• Harvard MPS defined as “injury [] caused by

medical management ([not] underlying disease) [] that prolonged hospitalization, produced a disability at the time of discharge or both.”

• Derived from tort law (as was definition of negligence)

• IOM defines “safety” as “freedom from accidental injury”

– Kohn et al To err is human: building a safer health system Wash DC: Nat’l Academy Press; 1999

“Adverse Events”

“Adverse events do not, of course, necessarily signal poor quality care; nor does their absence necessarily indicate

good-quality care.”

Brennan et al NEJM 1991 Feb 7;324(6):370-6

Negligence

• Defined as below standard expected of physicians in their discipline (and in their community)

• Expert physicians made determination• Sensitivity 89%

• Reliability (kappa) 0.24

• In sum – experts agreed that negligence was present but differed about extent of substandard care

• Crux of any tort litigation

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Negligence

“All this underlines the fact that physicians find it difficult to judge whether a standard of care has been met – hardly a surprising fact in view of the complexity of clinical decision

making.”

Types of Adverse Events

• In Harvard MPS• 48% were associated with an

operation (within 2 weeks of surgery or if caused by surgery regardless of timing)

• Less likely to be caused by negligence (17%) than nonsurgical AE’s (37%)

• 19% were drug complications• 14% were wound infections• 13% were “technical

complications”• Leape et al The nature of adverse

events in hospitalized patients. Results of the Harvard Medical Practice Study II N Engl J Med. 1991 Feb 7;324(6):377-84

Adverse Events

Surgery

Drugs

Wound

Technical

Types of Adverse Events

• Negligence most commonly found in• “Therapeutic mishaps” (injuries that resulted from

complications of non-invasive therapy) (77%)

• “Diagnostic mishaps” (injuries that resulted from an improper or delayed diagnosis) (75%)

• ER AE’s (70%)• Leape et al The nature of adverse events in

hospitalized patients. Results of the Harvard Medical Practice Study II N Engl J Med. 1991 Feb7;324(6):377-84

Total Cost

• $4 billion (1989) dollars (6.5 billion today)• ¼ out of pocket expense

• Fewer than 2% of patients with presumed negligent injuries filed a suit

• Johnson et al The economic consequences of medical injuries: implications for a no-fault insurance plan JAMA 1992;267(18):2487-92

• Leape Scope of Problem and History of Patient Safety Obstet Gynecol Clin N Am 35 (2008) 1-10

Progress

• 1995 – 1999 – first studies of systems analysis in adverse drug events

• Use of computerized physician order entry

• Use of bar coding

• Pharm on rounds in ICU

• Role of sleep deprivation on medication errors

• Leape Scope of Problem and History of Patient Safety Obstet Gynecol Clin N Am 35 (2008) 1-10

IOM report 1999“To Err is Human”

• Extrapolated from Harvard MPS data • Estimated 44,000 - 98,000 preventable deaths each

year in US caused by medical error

• Harvard MPS replicated in following countries with similar results

• Australia, NZ, UK, Denmark, France, Netherlands, Canada

• Consensus : 10% of hospitalized patients experience a treatment-caused injury and at least 50% are preventable

– Leape Scope of Problem and History of Patient SafetyObstet Gynecol Clin N Am 35 (2008) 1-10

Page 33

IOM report 1999“To Err is Human”

• Huge headlines – first major push for patient safety since 1995

• Some say ended period of denial

• 2001 - Congress appropriated 50 million annually to Agency for Healthcare Research and Quality for patient safety research

• 2004 required that these funds be directed towards studies of information technology (cut off funding for other safety initiatives)

Reduction of Adverse Events• Advances in medical knowledge

• “Safer” drugs• Advances in surgical procedures/equipment

• Systems analysis• Identification of safe practices disseminated as practice

guidelines or checklists• Learn from airlines/pilots; nuclear power; restaurants• Aviation Safety Reporting System• Institute for Nuclear Power Operations

• Education• Enforcement of practice guidelines and minimal standards

for priviledges– Leape et al The nature of adverse events in hospitalized

patients. Results of the Harvard Medical Practice Study II N Engl J Med. 1991 Feb 7;324(6):377-84

Systems Analysis

• Aviation Safety Reporting System (ASRS)• Created in 1976 in reaction to a 1974 TWA crash

and subsequent near miss by United six weeks after. • ASRS allows pilots, flight attendants, mechanics and

air traffic controllers to confidentially report incidents and near misses.

• Reviewed and can result in safety bulletins disseminated to the industry as a whole.

• Open for research analysis on the internet.• Institute for Nuclear Power Operations (INPO)

created after three mile island and promulgated training regulations for nuclear power personnel

• Significant decrease in AE’s• Increase in productivity

Anesthesia• First medical specialty to champion patient safety as a

specific focus as early as 1978• 47 interviews; 359 preventable accidents were described

• Human error in 82% of preventable accidents• Equipment failure in 14%.

– Cooper et al Preventable anesthesia mishaps: a study of human factors Anesthesiology. 1978 Dec;49(6):399-406

• Anesthesia Patient Safety Foundation formed 1985• Multidisciplinary• Electronic monitoring in 1980’s with development of minimal

safe monitoring practices• Extended residency to three years• Simulation

• 10 to 20-fold reduction in mortality and catastrophic morbidity for healthy patients undergoing routine anesthetics

ICU’s and Checklists Provonost Checklist• Line placement

• Wash hands with soap• clean the patient’s skin with chlorhexidine antiseptic• put sterile drapes over the entire patient• wear a sterile mask, hat, gown, and gloves• put a sterile dressing over the catheter site once the line is in

• Nurses observed x 1 month; MD’s skipped at least one step 1/3 of time

• Next month, nurses stopped MD’s if they skipped a step• Ten-day line-infection rate decreased from 11% to 0• Follow-up 15 months – only one line infection• Checklist had prevented forty-three infections and eight deaths,

and saved two million dollars in costs.

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Barriers to Reduction of Adverse Events

• Encourage reporting• Survey data – MDs want to communicate about

errors but find current systems inadequate– Garbutt et al Lost Opportunities: How Physicians

Communicate About Medical Errors Health Affairs, 27, no.1 (2008):246-255

• Changes to legal system• Tort law

– Liang Error in Medicine: Legal Impediments to US Reform JHealthPolLaw 24(1) 1999: 27-58

Progress

• JCAHO• Unannounced accreditation audits

• National Patient Safety Goals

• ACGME• Work hours (2003)

• Define competencies for each specialty

• Continuing evaluation of practicing physicians

Progress

• Institute for Healthcare Improvement• 100,000 lives campaign – reduction in mortality for

122,000 patients

• 5 million lives campaign• Included the Surgical Care Improvement Project – to

date has not shown clinically significant reduction in post-operative infections.

» Stulberg et al Adherence to Surgical Care Improvement Project Measures and the Association with Postoperative Infections JAMA 2010;303(24):2479-2485

Progress

• Leapfrog Group• Letter grades for hospital safety

• Massachusetts hospitals on average received highest safety scores (44/57 received an A including BIDMC)

• Advocates centralization of highly technical surgical procedures to high volume centers / “Centers for Excellence”

• Unclear if truly useful practice beyond cancer surgery

» Fink et al Trends in Hospital Volume and Operative Mortality for High-Risk Surgery N Engl J Med. 2011 June 2; 364(22): 2128–2137

Specific Adverse Events

• Hospital acquired infections• CDC estimates 1.7 million hospitalized patients

acquire an infection• 126,000 are caused by resistant staph

• 99,000 are fatal– www.cdc.gov/HAI/pdfs/hai/infections_deaths.pdf

2007

• Obstetrics

Systems Analysis

• Airline Industry

• Nuclear Power

• Restaurants• Leape Error in Medicine JAMA 1994;272:1851-7

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Overview


• History



• Safe Access

FDA data – Trocar Insertion Complications

• Trocar insertion accounts for 40% of laparoscopic complications (and most fatalities not anesthesia related)

• Fatalities• Cause of death

• Unrecognized bowel injury• Major Vessel Injury

– Included aorta, IVC, Mesenteric vessel, Iliac artery and vein, Gastroduodenal artery, Hypogastric artery, Omental vessel, Portal vein

• Type of procedure• Chole, Diag LSC, Tubal, Apy, LND

• Fuller,J et al. Trocar associated injuries and fatalities: Analysis of 1399 Reports to FDA. J Minim Invas Gyn 2005;12:302-307

Potential Complications – Small Bowel Injury

Potential Complications – Small Bowel Injury with Optical Trocar

Potential Complications – Aortic Injury Robotic Repair Aortic Injury

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Potential Complications – Inferior Epigastric Injury

Potential Complications – Gastric Perforation

Potential Complications - Hernia Potential Complications - Hernia

Overview


• History



• Safe Access

Cochrane Review 2012• 28 randomized controlled trials

• 4860 laparoscopic surgeries• Studies were small, some excluded patients with previous

abdominal surgery or those with raised BMI• No difference or advantage between methods in terms of

preventing major vascular or visceral complication• Advantage of open-entry over Veress – failed entry• Advantage of direct-entry over Veress – failed entry,

extraperitoneal insufflation, omental injury• Direct entry was described as a safer technique

• STEP trocar decreases trocar site bleeding• Advantage to NOT lifting abdominal wall before Veress

insertion• Ahmad et al Laparoscopic entry techniques Cochrane

Database Syst Rev. 2012 Feb 15;2:CD006583

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Cochrane Review 2008

• 17 randomized controlled trials• 3040 laparoscopic surgeries

• No difference or advantage between methods in terms of preventing major complications

• Advantage of direct over Veress – failed entry, extraperitoneal insufflation

• STEP trocar decreases trocar site bleeding• Advantage to NOT lifting abdominal wall before

Veress insertion• Ahmad et al Laparoscopic entry techniques

Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006583

SOGC Guidelines• Left upper quadrant entry

• suspected or known periumbilical adhesions; history or presence of umbilical hernia; three failed insufflation attempts at the umbilicus. (II-2 A)

• Other sites of insertion (transuterine Veress CO(2) insufflation) may be considered if the umbilical and LUQ insertions have failed or have been considered and are not an option (I-A)

• Veress needle safety tests or checks not necessary. (II-1 A)• VIP-pressure </= 10 mm Hg is a reliable indicator of correct intraperitoneal

placement of the Veress needle (II-1 A) • Elevation of anterior abdominal wall at the time of Veress or primary trocar

insertion not routinely recommended (II-2 B) • Angle of the Veress needle insertion should vary according to the BMI of the

patient, from 45 degrees in non-obese women to 90 degrees in obese women. (II-2 B)

• High intraperitoneal (HIP-pressure) laparoscopic entry technique does not adversely affect cardiopulmonary function in healthy women (II-1 A)

• Direct insertion of the trocar without prior pneumoperitoneum is safe alternative to Veress needle technique. (II-2)

• Direct insertion of the trocar is associated with less insufflation-related complications such as gas embolism, and it is a faster technique than the Veress needle technique. (I)

• Vilos et al Laparoscopic entry :a review of techniques, technologies and complications JObstet Gynaecol Can. 2007 May;29(5):433-65

Overview


• History



• Safe Access

Veress ChecklistPre-entry

Proper Positioning Arms tucked Table flat and functioning (test Tbird) Grounded

Proper sterile prep and drapeAll equipment functioning properly

and on field Test monopolar/bipolar Test camera/light/video system Test CO2, ensures tanks full Necessary Equipment available in

room (specific to operation)

Anesthesia Adequate relaxation NG/OG tube

Entry and Post-entryElevate abdominal wall

must elevate fascia not just sub-Q

Incision appropriate for eventual trocar insertion LUQ if suspicion of umbilical adhesions

or hernia; after 3 failed attempts at umbilicus

CO2 attached to Veress at low flow 45° angle of insertion

modified to 90° if obeseVIP pressure ≤ 10 mmHg at entry Increase to high flow and establish

pneumo consider HIP entry for primary trocar

entry

Full abdominal scan after camera entry ensure no injury before change in

patient position and proceed with case

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Open ChecklistPre-entry

Proper Positioning Arms tucked Table flat and functioning (test Tbird) Grounded

Proper sterile prep and drapeAll equipment functioning properly

and on field Test monopolar/bipolar Test camera/light/video system Test CO2, ensures tanks full Necessary Equipment available in

room (specific to operation)

Anesthesia Adequate relaxation NG/OG tube

Entry and Post-entry

Incision adequate for visualization Direct visualization of abdominal

fascia Kocher clamps on fascia

Incision made through fasciaElevate peritoneum and incise“Finger sweep”Stay suturesFull abdominal scan after

camera entry ensure no injury before change

in patient position and proceed with case

Major Vascular Injury Checklist

Call for Vascular Surgery Immediately (substantial delay found in Baggish study)

Midline IncisionSponge stick – apply pressure, do not clampType and Cross 6 U PRBC / 2 FFP

Massive Transfusion Protocol Send CBC, Plt, Fibrinogen, Split products

Instruct Anesthesia to call for assistInstruct OR personnel call for assistAssign one circulator to run stats/records

Baggish et al Analysis of 31 cases of major vessel injury associated with gynecologic laparoscopy operations J Gynecol Surg

2003;19(2):63-73

References1. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. The New England journal of medicine 1991;324:370-6.2. Kohn L, Corrigan J, Donaldson M. To Err is Human: National Academy Press; 1999.3. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. The New England journal of medicine 1991;324:377-84.4. Johnson WG, Brennan TA, Newhouse JP, et al. The economic consequences of medical injuries. Implications for a no-fault insurance plan. JAMA : the journal of the American Medical Association 1992;267:2487-92.5. Leape LL. Scope of problem and history of patient safety. Obstetrics and gynecology clinics of North America 2008;35:1-10, vii.6. Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia mishaps: a study of human factors. Anesthesiology 1978;49:399-406.7. Gawande A. The checklist manifesto : how to get things right. 1st ed. New York: Metropolitan Books; 2010.8. Garbutt J, Waterman AD, Kapp JM, et al. Lost opportunities: how physicians communicate about medical errors. Health affairs 2008;27:246-55.9. Liang BA. Error in medicine: legal impediments to U.S. reform. Journal of health politics, policy and law 1999;24:27-58.10. Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA : the journal of the American Medical Association 2010;303:2479-85.11. Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high-risk surgery. The New England journal of medicine 2011;364:2128-37.12. Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. The Cochrane database of systematic reviews 2012;2:CD006583.13. Vilos GA, Ternamian A, Dempster J, Laberge PY, The Society of O, Gynaecologists of C. Laparoscopic entry: a review of techniques, technologies, and complications. Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC 2007;29:433-65.

Page 39

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

Page 40

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

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