Avoiding Liability Risks Associated with GI Endoscopic

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Avoiding Liability Risks Associated
with GI Endoscopic Procedures
1
MARTI ERWIN, RN, JD
OCTOBER 2010
Hospital or Endoscopic Center Systems to
Reduce Risks
2
 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 Nurse
3
 Role still evolving
 Advanced assessment of the GI patient
 Initiates 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 and LPN Roles
4
RN Role Delineation
LPN Role Delineation
 Systematically assesses the
 Contributes to the planning,




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
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
Nursing Assistive Personnel
5
 Assists in data collection such as vital signs
 Assists, under direction of the GI RN, in
implementation of the plan of care
 Assists 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 Staff
6
 Consider the number of patients
 Layout of unit
 Patient acuity
 Technology
 Education and experience and competency of staff
 Needs of community and patient population
Minimum Levels of Staffing
SGNA
7
 Pre-procedure
 Each Procedure Room
•
 Post Procedure
1 RN
1 RN to Assess and
Monitor IV sedation
1 RN, LPN OR TECH TO ASSIST
1 RN
 Severe 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
8
 Physicians
 Sedation and Anesthesia Providers
 APRNs
 Employed RNs of Independent Physicians
Physicians
9
 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 forth
 Assessment of the endoscopist by his or her peers
determines competence
 Technical 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 Programs
11
 Endorsed and recognized by the Accreditation
Council for Graduate Medical Education or the
American Osteopathic Association
Threshold Number of Procedures
12
 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
13
 Fellowship or training program director evaluation
and observation of procedures
Privilege Determination
14
 Separate for each type of endoscopic procedure
 Review of credentials provided by the training

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program director in writing
Review of curriculum
Confirm training and experience
Require an observed level of competence
Specify level of training, threshold number of
procedures and types of credentials needed
Endoscopy by Non-Physicians
15
 Base decision on competence in endoscopy, availability of

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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 Training
16
 For complex procedures, the physician needs to have
completed an approved GI fellowship
Competence in Sedation
17
 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?
18
 Negligent credentialing
 High awards
 Punitive damages because the health care institution
did not use ordinary care in determining the
competence and training of practitioners
Other Practitioners and Credentials
19
 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 Providers
20
 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 Risk
21
 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?
NO
22
 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 Assistant
24
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.
NO
25
 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.
FMG
26
 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.
YES
27
 She meets the requirements and was recommended
by her program director. She does not have to be
board certified to have privileges.
ERCP
28
 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 Hospital
30
 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 Consent
31
 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 Procedures
32
 Delineate the process to be used in performing GI

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

procedures
Outlines pre, intra and post procedural care
Outlines such things as sedatives used and vial sizes
One 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 Measurement
33
 ASGE and ACG have been working to define quality indicators for


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
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 Control
34
 ASGE Updated Control Guidelines
 Documented cases of infection complications are
rare –1 in 1.8 million procedures
 Stringent reprocessing required after each scope use
to prepare and disinfect for use
 General 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
Examples
35
 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 Nevada
36
 Class Action suit with 5000 potential claimants

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against Dr. Desai for potential infection of Hepatitis
C in patients
9 of the cases were genetically linked
106 were likely linked to the Clinic
Reusing syringes and single unit medication vials
Only $30 million in insurance
Department of Veterans Affairs
37
 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

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cleaning and sterilization regimen
Appropriate employee training
Retraining
Utilization of manufacturers guidelines
Cleansing and disinfection use two different processes
Utilization of AER or Sterilizer that is compatible with
the particular scopes that are being used for the
procedures
Ethical Considerations
39
 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 Claims
40
 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
Licensure
41
 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 LPNs
42
 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)
43
 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 Mining
44
 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
45
 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—
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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 Services
46
 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 Records
47
 Part of new health care law
 Been in works for years
 Incentives 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
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