Nurse Anesthesia Week 1 Part 2

Front 1

Sensitive tests have a low rate of

Back 1

false-negative results

Front 2

specific tests have a low rate

Back 2

false-positive results

Front 3

Any procedure performed without consent, the anesthesia provider may be liable for

Back 3

assault and battery

Front 4

What 4 elements must be proved to establish negligence?

Back 4

Duty
Breach of Duty
Causation
Damages

Front 5

What 3 factors influence the likelihood of a malpractice suit?

Back 5

Physician/patient relationship, adequacy of informed consent, quality of documentation

Front 6

Manufacturer’s liability ends with

Back 6

delivery of device with manual

Front 7

prima facie negligence

Back 7

It is used in modern legal English to signify that on first examination, a matter appears to be self-evident from the facts

Front 8

http://www.medleague.com/webstore/lawyersandjudges/medical_device_acc.htm

Back 8

info for law suits ie epidural/spinal hemotomas

Decoding Anesthesia Records

Front 9

3 Intentions of Consensus Documents

Back 9

Encourage manufacturer compliance
Provide for compatibility of components
Guide consumers’ expectations

Front 10

About ANSI American National Standards Institute (ANSI)

Back 10

A 501(c)3 private, not-for-profit organization (consumer driven)

Before 1988, most machines followed the standards of the American National Standards Institute (ANSI).
The Z79 standards

Front 11

ASTM International, originally known as the American Society for Testing and Materials (ASTM)

Back 11

Since 1988, all machines manufacturers follow standards established by the American Society of Testing and Materials. (ASTM)

Equipment related

Front 12

ISO (International Organization for Standardization)

Back 12

ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards
ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce the implementation of its standards. ISO does not regulate or legislate. However, countries may decide to adopt ISO standards

standards for anesthesia systems

Front 13

Center for Devices and Radiological Health

Back 13

Center for Devices and Radiological Health

Front 14

Pre-market notification 510(k)

Back 14

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.

Front 15

Medwatch Program

Back 15

, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products.
MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.

Front 16

MAUDE database

Back 16

MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

Front 17

FDA 510(k) role 10X

Back 17

Conduct a risk analysis
Identify design input or requirements for the device
Develop the design output or specifications for the device
Verify that the design output meets the design input
Hold design reviews at appropriate points during the design process to identify significant problems with the design or the design process
Validate that the design meets defined user needs and intended uses
Validate any software used in the device
Transfer the device design to production specifications
Control changes to the design during the design process and changes in the design of products on the market
Document design control activities in the design history file

Front 18

medwatch plan

Back 18

is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly

Front 19

ECRI Institute

Back 19

"is a consumer reports for equipment"

For more than 40 years, ECRI Institute, a nonprofit organization, has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, all to enable you to improve patient care.

Front 20

AANA Scope and Standards for Nurse Anesthesia Practice: Standard VIII

Back 20

Adhere to appropriate safety precautions, as established within the institution, to minimize the risks of fire, explosion, electrical shock and equipment malfunction. Document on the patient’s medical record that the anesthesia machine and equipment were checked.”

Front 21

AANA Scope and Standards for Nurse Anesthesia Practice: Standard VIII

Interpretation

Back 21

“Prior to use, the CRNA shall inspect the anesthesia machine and monitors according to established guidelines. The CRNA will check the readiness, availability, cleanliness, and working condition of all equipment to be utilized in the administration of the anesthesia care. When the patient is ventilated by an automatic ventilator, monitor the integrity of the breathing system with a device capable of detecting a disconnection by emitting an audible alarm. Monitor oxygen concentration continuously with an oxygen analyzer with a low concentration audible alarm turned on and in use.”

Front 22

What is Anesthesia Workstation?
6 factors

Back 22

Ventilation
Oxygenation
Cardiovascular status
Temperature
Neuromuscular function and status
Level of consciousness

Front 23

6 Major Causes of Patient Injury Due to Anesthesia Delivery Systems

Back 23

Hypoxia
Hypercarbia
Anesthetic agent overdose
Barotrauma
Foreign matter in the airway
Anesthetic agent underdose

Front 24

American National Standards Institute (ANSI Z-79) 7 codes for 1979 to 1983

Back 24

Legibility & visibility of gauges & dials
PISS on gas cylinder hangar yoke
Pipeline pressure gauges
Pressure regulators seek gas from pipeline first
Oxygen sensor shut off valve
Standard flow meter knobs
Vaporizer interlock system

Front 25

Change in Ohio Standards

Back 25

General anesthesia in office-based setting prohibited in 1997
Adoption of Administrative Code 4731-25 allows general in office - 2004
Specific provisions and standards
Guidelines for liposuction

Front 26

7 CRNA Responsibility responsibility standards

Back 26

Be aware of state standards
Adhere to professional standards
Use up to date anesthesia machine
Know your machine
Check your machine
Report problems to manufacturer, Medwatch and/or MAUDE database
Read AANA Newsletters for updates

Front 27

Federal Regulation Title 21

Back 27

Anesthesia Machine
Prescriptive device because of potential harmful effects or method of use

Not safe except under the supervision of a licensed practitioner

Front 28

A mishap is defined as

Back 28

an unfortunate accident

Front 29

Critical Incident is

Back 29

An occurrence that could have led to an undesirable outcome if not discovered or corrected in time
or
An occurrence that lead to an undesirable outcome ranging, from increased hospital stay to death or permanent disability

Front 30

The critical starting point for an

Back 30

evolution of an injury

Front 31

5 Strategies to Prevent Mishaps

Back 31

Experience
Knowledge
Preparation
Vigilance
Communication

Front 32

ECRI is a

Back 32

The ECRI (formerly the Emergency Care Research Institute) is an independent nonprofit health services
research agency that focuses on health care technology, health care risk and quality management, and
health care environmental management.

not consumer driven
"consumer reports of healthcare"

Front 33

First Critical Incident Study goals

Back 33

Goal to identify frequent incidents
Categorized preventable critical incidents
Analyzed patterns and trends
Retrospective to examine characteristics

Front 34

First critical incident study mishaps (2 top)

Back 34

human error 80%, equipment failure, then unable to categorize

Front 35

First Critical Study
top 3 most frequent incidents (critical incidents)

Back 35

breathing circuit disconnection
gas flow change
syringe swap

Front 36

First Critical Study
Occurrence of Incidence (most common time)
and
top 3 equipment failure

Back 36

mid case, second induction

Monitor, Breathing circuit, Anesthesia machine

Front 37

first critical incident study
top 2 associated factor with incidence

Back 37

inadequate experience (77), inadequate familiarity with equipment (45)

Front 38

First Critical study 7 conclusions

Back 38

inherent problems in retrospective interviews
Patient outcome not well defined
major cause human error
breathing circuit disconnection
Incidents occur during time least expected
Inadequate experience
Inadequate familiarity with equipment

Front 39

what is AIMS

Back 39

The Australian incident monitoring study: an analysis of 2000 incident reports.

Front 40

Australian Patient Safety Foundation characteristics

Back 40

Started in 1987 – 1st publication 1998
Reporting of critical incidents
Voluntary
Anonymous
Large sample (n = 2000 1st publication)
Medico-legal safety aided by Health Insurance Amendment Act of 1992
Declares AIMS as quality assurance activity

Front 41

AIMS Design

Back 41

“Any incident which did, or could have reduced the margin of safety”

Demographics of the case
Type of anesthesia, monitors used, where & when, experience of personnel, age & ASA of patient and outcome of case

Front 42

AIMS Data Analysis

Back 42

Defined broad topics to which incidents were applicable
Defined effectiveness of monitors
Tested validity of existing algorithms
Tested reliability and validity
Where one method of research yields similar results to another
Tested construct validity
Observations are consistent with current theory

Front 43

AIMS Broad Categories of Mishaps (main events)

Back 43

respiratory 65, equipment, then cardio

Front 44

AIMS top 3 main events with Problems with Ventilation

Back 44

disconnections, leaks, and misconnections

Front 45

AIMS 2 most common sites sites of misconnections

Back 45

Scavenger system
Co-axial circuit

Front 46

AIMS 56% of cases, the main contributing factor was

Back 46

“failure to check” the equipment

Front 47

AIMS recommendations for prevention of "contributing factors' (3)

Back 47

Meticulous checking of equipment
Use alarms on monitors
Hyper-vigilance for monitoring ventilation

Front 48

ASA Closed Claim project
(7) attributes

Back 48

Data collection from 35 insurance agencies
Coverage for 50% of US anesthesiologists
Current database = over 6,000 cases
Span of cases 1980-2000
No information regarding total number of anesthetics done in same time period
Unable to calculate statistical risk
Information delayed by approx. 10 years

Front 49

Damaging Events def.

Back 49

Specific incident or mechanism that leads to adverse event
Example: airway obstruction leading to brain damage

Front 50

Three top ASA closed claim project categories of adverse events

Back 50

Death
Nerve damage
Brain damage

Front 51

ASA 4 Strategy to decrease adverse events (4)

Back 51

Reduce incidence of cases with high payments and high frequency
Use standard of care for every patient
Use monitors for every patient
Be vigilant!

Front 52

ASA 3 Recurring patterns of injury

Back 52

Adverse respiratory events
Nerve injury
Sudden cardiac arrest during spinal & epidural anesthesia

Front 53

ASA Adverse respiratory events 5 factors

Back 53

Single largest source of injury
Detailed analysis done in 1990
85% resulted in brain damage or death
Median payment = $200,000
72% judged preventable with monitoring with
Pulse oximetry &
Capnography

Front 54

ASA 3 main mechanisms of injury r/t respiratory

Back 54

inadequate ventilation, esophageal intubation, difficult intubation

Front 55

ASA Nerve Injury

Back 55

In-depth analysis in 1990, 1999 (n = 610)
Accounted for 10-16% of all claims
Major nerve injuries
Ulnar nerve
Brachial plexus
Lumbosacral root
Occurs even when padded appropriately
75% of claims in males
New information emerging to decrease incidence

Front 56

ASA Spinal Cord Injuries (2 most common cause)

Back 56

Regional anesthesia leading to hematoma
Abnormal coagulation state (Anticoagulant therapy,
Intrinsic coagulopathy)

Front 57

ASA Sudden Cardiac Arrest 9 points

Back 57

Healthy males, spinal anesthesia for minor surgery
Death or brain damage occurred
High level of sympathetic block – T4
Arrest 30 minutes after spinal
CPR + epi after approx. 7 minutes
Animal studies done that showed low coronary perfusion pressure during CPR when spinal sympathetic block present
Associated with vagal stimulation
Monitor closely at 30” and give epi early

Front 58

ASA Post-op Visual Loss 7 points

Back 58

Spinal surgery
due to ischemia to optic nerve
Long surgery (8 hours median)
Large blood loss (2.3 liters)
Prone position
Eyegards with plastic rims
Cardiopulmonary bypass cases

Front 59

AANA Closed Claim Study (make up and questions)

Back 59

Research team of 8 CRNAs
Examined 223 closed claims from 1995-1997
Respiratory events that led to negative outcomes
Made judgments regarding following:
Was event related to CRNA?
Did CRNA vigilance contribute?
Was event preventable with better monitoring?

Front 60

AANA Closed Claim Study findings (5)

Back 60

76% care was judged as substandard
66-85% resulted in death or brain damage
72-81% preventable with better monitoring
Esophageal intubation is common in difficult airway management
Esophageal injury most severe airway related injury

Front 61

Provider Factors AANA closed study claims (7)

Back 61

Human error is common (in 80% of cases)
Medication errors are commonplace
Injecting wrong drug
Incorrect injection of a properly labeled syringe
Infusion errors or syringe swaps
Inadvertent paralysis before induction accounted for 40% of awareness while under anesthesia
Inadequate pre-induction activities contribute
Following Standard of Care ?
50% of cases did
Led to smaller monetary rewards

Front 62

AANA performance/monitoring suggestions

Back 62

Always use ETCO2 and SaO2
Use SaO2 continuously until PACU discharge
Monitors insensitive, unreliable as a warning of injury and may provide misleading information
Automated blood pressure cuffs
ECG
Use a stethoscope to augment monitoring
Regional anesthesia merits same level of monitoring & vigilance as general anesthesia
Consider early use of EPI when bradycardia develops
Of all claims that could have been prevented w/ better monitoring, 81% involved an airway incident

Front 63

Esophageal & Endobronchial Intubation aana closed claim

Back 63

22% of the respiratory related claims
7 of 10 were esophageal
3 of 10 were endobronchial
10 patient deaths
All went undetected until patient symptomatic
Bradycardic
Cardiac arrest
54% had no documentation of breath sounds after intubation

Front 64

Respiratory Arrest aana closed claim causes

Back 64

Causes
Undetected excessive sedation
Medication error (Vecuronium instead of Midaz)
Total sympathetic block during interscalene
Inappropriately managed residual neuromuscular blockade ( GA w/ ETT/ 2 doses of reversal/ETCO2 of 70/no O2 or vent to PACU/ arrested on adm)

Front 65

How do you document tracheal intubation

Back 65

Direct view of vocal cords
Watching ETT go through vocal cords
Bilateral equal breath sounds
ETCO2 times 5 waveforms