Anesthesia Charting Fidelity Study

1. Primary Objective: Conduct a prospective, observational pilot study that assesses the
frequency and severity of anesthesia charting fidelity weaknesses in three separate
clinical environments (Cardiac surgical operating room, cardiac surgical intensive care
unit, and electrophysiology laboratory) as assessed by a customized error scoring
system that focuses on the magnitude of errors among multiple continuous, categorical
and dichotomous variables. The errors are being assessed in order to identify the most
common charting inaccuracies so that target areas appropriate for testing of
improvement strategies may be isolated.

1. Cardiac surgical operating room: Any cardiac surgical procedure that involves the
use of cardiopulmonary bypass and planned postoperative intensive care unit
admission in an electronic supplemented anesthesia charting environment

2. Cardiac surgical intensive care unit: The cardiac surgical intensive care unit
environment during the first 2-3 hours following procedures referenced in section
I,A,1

3. Electrophysiology laboratory: select electrophysiology laboratory based procedures
that employ a paper anesthesia chart

2. Secondary and Exploratory Objectives:

1. Identify environmental variables that contribute significantly to medical record
errors.

2. Identify clinical role of individual responsible for charting

3. Investigate time of day/patterns that charting errors occur

4. Relationship of clinical acuity and event occurrences

5. Role of equipment malfunction and event frequency

6. Role of social distracters and event frequency

7. Role of monitor infidelity and event frequency

8. Role of delayed charting of event and frequency of errors

9. Identify/quantify the awareness of clinicians to their execution of medical record
errors through use of simple, multiple choice 4 question survey that clinicians
will be asked to fill out following a case study

10. Examine the relationship between the assessed environments and the frequency of
medical charting errors

11. Identify the areas of anesthesia charting most in need of improvement in order to
address designing ways to potentially improve these weaknesses.

Error scoring system:

1. The degree of charting fidelity error in this study will be converted via a
classification system to make data analysis more efficient. All types of errors that
involve continuous variables will be assessed with mean, median and standard deviation
as well as range. Numerical data points related to time will be classified into four
separate categories.

1. Class It: temporally accurate data will less than 2 minutes or 3.3% deviation from
actual time of event/observation.

2. Class IIt: temporally inaccurate data with between 2-3 minutes or 3.3-5% deviation
from actual time of event/observation.

3. Class IIIt: temporally inaccurate data with between 3-6 minutes or 5-10% deviation
from actual time of event/observation.

4. Class IVt: temporally inaccurate data with greater than 10% deviation (6 min) from
actual time of event/observation.

2. The degree of charting fidelity error observed with respect to hemodynamic parameters
will be classified as follows:

1. Class Ih: accurate hemodynamic data with less than 3% deviation from the
representative value recorded by the scribe.

2. Class IIh: inaccurate hemodynamic data with between 3-5% deviation from the
representative value recorded by the scribe.

3. Class IIIh: inaccurate hemodynamic data with between 5-10% deviation from the
representative value recorded by the scribe.

4. Class IVh: inaccurate hemodynamic data with greater than 10% deviation from the
representative value recorded by the scribe.

3. The degree of charting fidelity error observed with respect to whether a procedure
which was performed by anesthesia provider was charted will be assessed as a
dichotomous variable, Yes or No.

4. The degree of charting fidelity error observed with respect to whether a significant
intraoperative event, or intra-procedural event for the electrophysiology laboratory,
was charted will be assessed as a dichotomous variable, Yes or No.

5. The degree of charting fidelity error observed with respect to drug dosing will be
assessed as a dichotomous variable, Yes or No.

6. The degree of charting fidelity error as related to procedural details will be assessed
as a dichotomous variable, Yes or No.

7. Full statistical analysis making all possible comparisons of collected data will be
performed with the assistance of a trained statistician.

a. Inclusion criteria:

1. Male or female patients ≥ 18 years of age

2. Patients and the hospital staff that are caring for them, scheduled to undergo any
cardiac surgical procedure that involves the use of both general anesthesia (with
planned computer assisted charting using the PISCES system) and cardiopulmonary
bypass, including postoperative intensive care unit monitoring -or- Patients and the
hospital staff caring for them scheduled to undergo select electrophysiologic
procedures (detailed below 1 - 3) involving the administration of general anesthesia
in the electrophysiology laboratory with planned manual paper charting

1. Defibrillation threshold testing using non-invasive programmed stimulation of an
implantable cardiovertor defibrillator (ICD)

2. Transesophageal echocardiography guided electrical cardioversion of patients
with supraventricular arrhythmias

3. Electrical cardioversion of patients with supraventricular arrhythmias