MARTI ERWIN, RN, JDOCTOBER 2010

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Avoiding Liability Risks Associated with GI Endoscopic

Procedures

Hospital or Endoscopic Center Systems to Reduce Risks

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Appropriate staffing levels and skills mix Type of Staff needed for the community served and

the services offered APRN RN LPN Assistive Personnel

Scope of practice for nursing for state in which individual is licensed and practicing

Advance Practice Registered Nurse3

Role still evolvingAdvanced assessment of the GI patientInitiates and interprets diagnostic tests and endoscopy

procedures per an appropriate nurse practice agreement with a supervising physician

Systematically interprets clinical and diagnostic findings within normal and abnormal variations in making differential diagnoses.

Prescribes pharmacological agents and/or treatments within his or her prescriptive authority and state law

SGNA Position Statement; Role Delineation of the Advanced Practice Registered Nurse in Gastroenterology

RN Role Delineation LPN Role Delineation

Systematically assesses the health status of individuals and records related health data

Establishes a nursing diagnosis

Plans and implements nursing interventions

Administers and evaluates pharmacological and other therapeutic treatment regimens

Evaluates Outcomes of nursing intervention

Contributes to the planning, implementation and evaluation of patient care

Observes, records and reports significant changes in patient condition to the nurse or physician

Documents patient data to ensure continuity in the provision and coordination of care

Assists physician and/or GI RN during diagnostic and therapeutic procedures to promote optimal patient outcomes

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RN and LPN Roles

Nursing Assistive Personnel5

Assists in data collection such as vital signsAssists, under direction of the GI RN, in

implementation of the plan of careAssists physician and GI RN before, during

and after diagnostic and therapeutic procedures

Provides and maintains safe environment for patient and staff

Risk Reduction through Adequate Staff6

Consider the number of patients Layout of unitPatient acuityTechnologyEducation and experience and competency of

staffNeeds of community and patient population

Minimum Levels of StaffingSGNA

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Pre-procedure 1 RNEach Procedure Room 1 RN to Assess and

Monitor IV sedation• 1 RN, LPN OR TECH TO ASSIST

Post Procedure 1 RNSevere conditions and complex procedures such as

ERCP, PEG insertion, Large Polyp Removal, Double Balloon Enteroscopy requiring a higher level of sedation and pediatric patients must have a minimum of 1 RN plus an additional member of the team present at all times –normally 3 people for complicated procedures

Credentials and Privileging to Reduce Liability Risks

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PhysiciansSedation and Anesthesia ProvidersAPRNsEmployed RNs of Independent Physicians

Physicians9

Professional Associations such as the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG)establish standards for competence and methods for assessing competence of practitioners

What is competence? Minimal level of skill, knowledge and or experience

derived through training and experience that is required to safely and proficiently perform a task or procedure

How is competence determined?10

Training measures are set forthAssessment of the endoscopist by his or her

peers determines competenceTechnical and cognitive skills required to

accurately diagnose the patient and ensure that he or she receives the appropriate care

Training assures that only indicated endoscopies are performed, sedation and analgesia are given competently, patient risk factors are identified and steps are taken to minimize identified risks

Training Programs11

Endorsed and recognized by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association

Threshold Number of Procedures12

ACGE recommends performance of a minimum of 140 colonoscopies and 130 esophagogastroduodenoscopies (EGDs) be performed before competency can be assessed for the procedures

Short courses outside of training programs should be used as adjunctive or CME and are in no way adequate for training for Endoscopy

Evaluation of Competence and Training

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Fellowship or training program director evaluation and observation of procedures

Privilege Determination14

Separate for each type of endoscopic procedure

Review of credentials provided by the training program director in writing

Review of curriculumConfirm training and experienceRequire an observed level of competenceSpecify level of training, threshold number of

procedures and types of credentials needed

Endoscopy by Non-Physicians15

Base decision on competence in endoscopy, availability of physician resources, volume of patients needing procedure

Non-physician will not attain extensive formal training in gastrointestinal diseases sufficient to attain cognitive expertise needed for patient care

Performance of sigmoidoscopies as part of colon cancer detection has been determined as safe for the non-physician

Sigmoidoscopies for evaluation of symptoms has not been proven safe and is not recommended

If upper endoscopy and colonoscopy is to be performed by a non-physician, a qualified physician must supervise

Never use non-physicians for therapeutic procedures

Advanced Training16

For complex procedures, the physician needs to have completed an approved GI fellowship

Competence in Sedation17

Must be able to recognize various levels of sedation from minimum to general anesthesia

Must understand the pharmacology of each sedative they intend to use and the reversal agent

Must be able to appropriately monitor each sedation technique

Must be able to recognize complications of sedation and to rescue the patient.

What risk is associated with credentialing and why is it important?

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Negligent credentialingHigh awardsPunitive damages because the health care

institution did not use ordinary care in determining the competence and training of practitioners

Other Practitioners and Credentials19

APRN Scope of practice determined by state in which

individual is licensed Nurse practice agreement in writing with supervising

physician Appropriate DEA certification Meets the requirements set forth by the state for

advance practice in the desired area of specialty and must be the same as the supervising physician

Other Providers20

PAs normally have the same scope of practice as the physician that they work with. Must also have a clear delineation of privileges and must not be outside of supervising physician scope

RNs who work for an independent practitioner Privileges based upon scope of practice as an RN in

the state in which licensed

Scenarios of Risk21

Physician on staff trained in flexible sigmoidoscopy by a local physician and performing these for 12 years applies for hospital privileges for colonoscopy. He has been using a colonoscope on selected patients and has been reaching the cecum in many patients. He attended a two day seminar on colonoscopy and has a certificate and now he wants privileges. Does he meet criteria?

NO22

He does not meet the ASGE requirements for privileges and thus should be denied. He has no formal training in gastroenterology or surgery and the requisite cognitive and procedural skills are not present to perform this procedure safely and competently.

Minimum of 140 colonoscopy procedures in training program before an assessment is made of the physician’s qualifications.

What are the legal ramifications?23

What if he perforates a bowel and the patient subsequently dies? Whose fault? Physician Hospital and MEC

Physician Assistant24

Family practice has a PA to perform colonoscopies. He trained with a GI group in another state. He has done 200 supervised colonoscopies and has good references. He wants unrestricted privileges to perform colonoscopies at the hospital No family practitioner has endoscopic privileges.

NO25

While it may be safe for a PA to perform flexible sigmoidoscopy as part of colon screening, it is not appropriate for the PA to perform unrestricted colonoscopies in an unsupervised manner.

FMG26

Foreign Medical Graduate with training in non-US hospital completed a three year gastroenterology fellowship in US and has more than 500 EGDs and colonoscopies and a good letter of reference. She has an unrestricted medical license and is a permanent resident alien. She cannot be boarded by the ABIM because she can’t take the exam in gastroenterology. Wants privileges.

YES27

She meets the requirements and was recommended by her program director. She does not have to be board certified to have privileges.

ERCP

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Physician completed three years of endoscopic training. During third year he was involved with 133 ERCP procedures, but the staff physician completed most of these. His evaluations noted he was not competent to perform independent ERCPs. He wants privileges to perform the ERCP.

??29

No. ERCP is complicated and advanced endoscopic procedure. Can have serious life threatening short term and long term complications. Studies indicate 180 to 200 procedures needed for the trainee to be competent. Must meet objective performance criteria because of the serious nature of this procedure. ASGE requirements not met.

Problem for Hospital30

Liability– If hospital privileges an unqualified physician to do such a complex procedure and did not follow ASGE guidelines or recommendations from the trainee’s program, then we would have serious negligent credentialing issues to deal with.

Consent and Informed Consent31

Considered a Pre-procedure quality indicator Consent to Treat

Hospital responsibility Avoids allegations of battery More specific than general consent on the COA

Informed Consent Requires evaluation of patient’s cognitive function Done by treating physician Involves detailed discussion of the procedure, the risks,

benefits and alternatives to the procedure Patient must have opportunity to get all his questions

answered by his physician Always done prior to sedation taking effect and prior to

procedure

Policies and Procedures32

Delineate the process to be used in performing GI procedures

Outlines pre, intra and post procedural careOutlines such things as sedatives used and vial

sizesOne large indicator of standard of care—a legal

standard to which a physician and other health care providers are held

If your policy indicates that you will use and follow these policies and procedures and then you don’t, you must have a really defensible reason for deviating in the case

Quality Indicators and Measurement33

ASGE and ACG have been working to define quality indicators for GI care

SGNA has been working to establish data sets for use during the pre, intra and post procedure periods of care.

Such indicators establish potential databases for decision making such as staffing levels, medication and supply needs, etc.

Also can set the hospital up for comparison among other hospitals if the quality indicators and used and published

Provides one indication that the standard of care was not followed if the quality indicators in a case situation demonstrate that the case fell below accepted standards on the indicators or that there was a pattern and the hospital consistently did not meet quality standards.

Provides a measuring stick for programs, physicians and for pay for performance

Infection Control34

ASGE Updated Control GuidelinesDocumented cases of infection complications

are rare –1 in 1.8 million proceduresStringent reprocessing required after each

scope use to prepare and disinfect for useGeneral infection control principles required

Aseptic technique and safe injection practices Single use vials Utilization of gloves and infection control standards to

reduce clostridium difficile associated diarrhea

Examples35

Desert Shadow Endoscopy This case really involved the use of 50 ml vials of

propofol, a sedative utilized for endoscopy Henry Chanin, plaintiff, was infected with Hepatitis C

during the 2006 colonoscopy he had. He sued Teva, the Parenteral Medication provider and Baxter Healthcare.

CRNAs had used the same syringes on multiple patients rather than using a new syringe each time the propofol was used

Large vials temp the CRNAs to reuse the syringes

Endoscopy Center of Southern Nevada36

Class Action suit with 5000 potential claimants against Dr. Desai for potential infection of Hepatitis C in patients

9 of the cases were genetically linked106 were likely linked to the ClinicReusing syringes and single unit medication

vialsOnly $30 million in insurance

Department of Veterans Affairs37

3174 veterans in Georgia, Tennessee and Florida

Allegations of improperly processed endoscopy equipment causing Hepatitis B, C and HIV

Risk Reduction 38

Institutional program for processing equipment Cleaning according to accepted protocols Disinfecting according to policy

Written procedures for monitoring adherence to the cleaning and sterilization regimen

Appropriate employee trainingRetrainingUtilization of manufacturers guidelines Cleansing and disinfection use two different processesUtilization of AER or Sterilizer that is compatible with

the particular scopes that are being used for the procedures

Ethical Considerations39

Patient Satisfaction Happy patients usually do not sue Technical Quality of the procedure Comfort and tolerability Art of caring Adequate explanations and information by physician Reductions in wait time

Happy patients rarely sue

False Claims40

Submission of a claim to the Federal government when it is known to be false

Includes claims for payment from Medicare and Medicaid (ex. UB-92) Requires certification that the claims are consistent with the law. If the claim is for services ordered by a physician with whom the

hospital has a prohibited financial relationship, it is not consistent with the law.

Any original source can alert the government when a false claim has been made (“whistle blower lawsuit”) Original source may receive a monetary percentage of the

damages. This is how most cases start

Many states also have state-specific false claims acts. New laws have made it possible for Medicare and Medicaid

to suspend payments pending an investigation

Licensure41

How critical is licensure anyway? All individuals working in endoscopy that are required

to be licensed should hold a license If not, what are the ramifications?

Physician If his license has lapsed, then every procedure he has

performed since the lapse would have to be reviewed and potentially rebilled to avoid False Claims liability

RNs and LPNs42

Law requires licensed personnel.If unlicensed, compliance issues and possible

issues with billing for services provided by unlicensed personnel

Patient Protection and Affordable Care Act (PPACA)

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Changes occurring that we are really not sure about to date

Emphasis on Quality and payment for quality care

Payment adjustments for conditions acquired in hospitals –hospitals in top 25th percentile of all for certain hospital acquired conditions will be subject to 1% reduction in payments

Data Mining44

Data mining and health informatics used to identify patients at high risk for readmission

More transparency on health and risk data will increase information available not only to insurers, federal government, etc., but also to attorneys

Restrictions on Physician Investment in Healthcare Entities

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Reduces Physician owned hospitals by not allowing more to start

Restricts physician investment in health care entities and requires disclosure of that interest to patients.

Physician ownership in manufacturers or GPOs regulated— Must disclose the investment and terms Must make the information public Must let patients know physician’s ownership Manufacturers have to report electronically to Secretary of

HHS, those gifts made to physicians and teaching hospitals and physician ownership in the organization

Increased Primary Care Services46

PPACA will provide for an increase in primary care services such as those focused on screenings and preventive health services.

General removal of barriers for Medicare beneficiaries to obtain preventive services

Electronic Medical Records47

Part of new health care lawBeen in works for yearsIncentives to hospitals and physicians to get

electronic medical records for patients in a form that promotes exchange of information, immediate availability of records and information, and theoretically promotes the improvement of individual health care for patients

Financial incentives, bonus from Medicare, target date 2015