US Instrument Survey for new cardiovascular IVD to be launched in ED's

Biz Case for new healthcare device

1. © 2002 EAC Enterprise Analysis Corporation
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CanaryCanary
US Instrument US Instrument
SurveySurvey
A Confidential Report
Prepared for Ortho-Clinical Diagnostics
EAC, Enterprise Analysis Corp.
Stamford, Connecticut
October 21, 2002

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©2002 EAC
2Table of ContentsTable of Contents
•Executive Summary
•EAC’s Assignment
•Chest Pain Visits to the ED
•Acceptance of Existing Instrument
•Current Chest Pain Protocols
•ED Workflow
•POC Testing in the ED
•ED POC Instrument Design Requirements
•Purchasing Process
•Appendix

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©2002 EAC
3Executive SummaryExecutive Summary
•The instrument as it is currently configured will struggle for
acceptance in the Emergency Department
•The 90 second result is more valued by the ED staff than POC
coordinators
–Higher ED willingness to consider the current instrument configuration
–Laboratory staff intolerant of instrument’s shortcomings
•Improved turnover in monitored beds might produce significant
ED and hospital economic benefits
•With the exception of glucose testing (and some kits) very little
POC testing is being done in the ED
–No time for testing that isn’t one-step and instantaneous
–Lab culture and politics reinforce resistance to ED testing
•There is general consistency in tests being ordered among all
EDs surveyed
–Some variation in the timing and variety of cardiac markers

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©2002 EAC
4Executive Summary (cont)Executive Summary (cont)
Features
Definitely
Acceptable
Probably
Acceptable
Probably Not
Acceptable
Definitely Not
Acceptable
Specimen
Collection and
processing
•Snap tube
into cartridge
•Absorbent
strip with
finger stick
•Absorbent
strip at site of
draw (OK for
ED)
•Absorbent
strip at site of
draw (not OK
for POC)
•Pipette
specimen
into cuvette
•Centrifuge
sample
Instrument
Size for Use in
ED
•Handheld
•Toaster size
and portable
•Toaster size
and fixed
Quality
Control
•Control built
into cartridge
to run
simultaneous
with
specimen
•Pipette and
run control
solution prior
to each
specimen

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©2002 EAC
5EAC’s AssignmentEAC’s Assignment
•Objective
–Provide information from potential users of an Emergency
Department POC instrument to help OCD make critical
instrument design decisions
•Scope of Work
–EAC completed written questionnaires with 113 POC
Coordinators and 97 Emergency Department Administrators
representing 210 institutions in 49 states
•Primary criteria for inclusion: 30,000 or more ED visits annually
•Methodology
–EAC administered the questionnaire in a 30 to 40 minute
telephone conversation for which participants received an
honoraria
–Questionnaires for the POC and ED staff were different
however areas of common content included
•Acceptance of the existing “Picofluor” design
•Instrument features including size, specimen collection and quality control
procedures

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©2002 EAC
6
Chest Pain VisitsChest Pain Visits

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©2002 EAC
7
Visits for “Chest Pain” complaints:Visits for “Chest Pain” complaints:
Percent of Emergency Department VisitsPercent of Emergency Department Visits
•There were wide ranges in the percent of patients presenting
with chest pain;
–Low: 1% at Phoenix Indian Services Hospital in Phoenix, AZ
– High: 60% at Genesys Regional Medical, in Grand Blanc, MI
11%
22%
36%
19%
8%
4%
0%
10%
20%
30%
40%
50%
<5% 5%-9% 10%-19% 20%-29% 30%-39% 40% up
Percentage of Patients with Chest Pain
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©2002 EAC
8Visits for Stroke – Patients per dayVisits for Stroke – Patients per day
•A majority of hospitals (62%) have only 1 or 2 presentations for
stroke a day
–3 institutions reported 10+ stroke presentations per day
–High: St. David’s in Austin, TX is a designated stroke center and reported
18 presentations per day
59%
23%
13%
5%
0%
10%
20%
30%
40%
50%
60%
70%
Under 2 3 - 5 Over 5 No Answer
Stroke patients per day
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©2002 EAC
9Visits per bed and per monitored bedVisits per bed and per monitored bed
•Improved turnover in monitored beds might produce
significant ED and hospital economic benefits
Total visits per
Beds
Chest Pain Visits
per Monitored Bed
High 3330 1754
Low 917 30
Average 1794 455
Daily Turnover 4.9 1.2

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©2002 EAC
10
Acceptance of Current Instrument DesignAcceptance of Current Instrument Design

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©2002 EAC
11
Likelihood of Placing and Using Instrument as Likelihood of Placing and Using Instrument as
DesignedDesigned
•ED participants were more forgiving of the current
instrument design than were the POC respondents
Number of Responses Total
POC 54 23 25 11 0 113
ED 11 9 30 26 21 97
ALL 65 32 55 37 21 210
Likely to Place and Use This Instrument in the ED
48%
20%
22%
10%
0%
11%
9%
31%
27%
22%
31%
15%
26%
18%
10%
0%
10%
20%
30%
40%
50%
60%
Very Unlikely Unlikely Neutral Likely VeryLikely
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POC ED ALL

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©2002 EAC
12
Likelihood of Placing and Using Instrument as Likelihood of Placing and Using Instrument as
Designed – Comments from EDDesigned – Comments from ED
•Comments from those participants who were likely
or very likely to use the instrument focused
strongly on the turnaround time of the test
–“Turnaround time is great!”
–“Very concerned with TAT and frustrated with lab results”
–“Quick response rates would be a huge help”
•Comments from those unlikely or very unlikely to
use the instrument were more diverse
–“Don’t like the idea of transferring blood from one tube to
another”
–“Hospital will not allow ED to do tests that aren’t CLIA waived”
–“Already too many constraints on the staff to ask them to run
another test”
–“There could be problems with controls and checking
equipment”

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©2002 EAC
13
Likelihood of Placing and Using Instrument as Likelihood of Placing and Using Instrument as
Designed – Comments from POCDesigned – Comments from POC
•Those individuals who indicated they were “likely”
to place and use the instrument in the ED made
remarks that reflected their concerns
–“There could be a problem mixing two components – could the
mixture come in one packet?”
–“Concerned that different nurses would have different skill
levels”
•Those who indicated they were unlikely or very
unlikely to use the instrument in the ED were very
concerned with the ability of the ED staff to
perform the test correctly
–“RNs are not laboratorians”
–“Compliance would be low with too many steps”
–“They closed STAT lab due to ER issues”

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©2002 EAC
14
Likelihood of Placing and Using Instrument as Likelihood of Placing and Using Instrument as
Designed (cont)Designed (cont)
•Acceptance of the instrument was slightly higher
for the Emergency Departments with more visits
until you get to the largest and then acceptance
drops off
–Sample sizes here get small and should be considered
directional
•POC participants were asked “would a moderately
complex POC device be acceptable for use in the
ED” and 61% indicated that it would

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©2002 EAC
15
Current Chest Pain ProtocolsCurrent Chest Pain Protocols

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©2002 EAC
16When and what tests are orderedWhen and what tests are ordered
•41 institutions (42%) reported that standing test
orders exist so that upon triage, the attending RN
can do a blood draw and start the test process
–The remaining institutions do not order tests until the patient
sees a physician – however it was frequently noted that with
patients with chest pain complaints see a physician within 5
minutes
•Virtually all institutions order Troponin, a CBC,
and the Basic (or Comprehensive) Metabolic
Panel as a standard for diagnostic determination

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©2002 EAC
17Tests ordered on chest pain presentationTests ordered on chest pain presentation
Test Ordered At Triage
At
Clinician
Review
Total
Troponin* 40% 59% 99%
CBC 42% 53% 95%
CK-MB 39% 53% 92%
Coagulation (primarily
PT)
35% 52% 87%
Myoglobin 22% 36% 58%
Comprehensive
Metabolic Panel
19% 39% 58%
Basic Metabolic Panel 24% 25% 49%
* 1 Institution orders Troponin 1 hour after presentation

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©2002 EAC
18
•Other blood work mentioned included lipids (3)
blood sugar (2), cholesterol (2), and triglycerides
(2)
• Urine based tests were also noted from time to
time
Tests ordered on chest pain presentation (cont)Tests ordered on chest pain presentation (cont)

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©2002 EAC
19Information that is monitoredInformation that is monitored
•The same information is monitored on chest pain
patients and stroke patients
Chest Pain
Patients
Stroke Patients
EKG 100% 98%
Blood Pressure 99% 97%
Pulse 99% 97%
O
2
Saturation 80% 77%
Temperature 69% 66%
Respiration 54% 51%
Blood Gas 21% 18%

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©2002 EAC
20
Emergency Department WorkflowEmergency Department Workflow

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©2002 EAC
21Workflow: who draws blood Workflow: who draws blood
•92% of the EDAs (89 respondents) report that the
emergency department staff does the blood draw;
the remaining respondents indicated that blood
draw is done by lab staff, some of whom are
resident in the ED
Person Performing Draw Count
Percent
(of 89)
LPN and RN 88 99%
Emergency Techs, Nurse
Assistants and Paramedics
60 67%
MD, Interns, PA 9 10%
Phlebotomist 9 10%

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©2002 EAC
22Workflow: specimen labels, pediatric tubes, staffWorkflow: specimen labels, pediatric tubes, staff
•58% of respondents indicated that they produce
barcoded labels for the specimens
–39% indicated that the labels are printed by computer but are
not barcoded
–11% use manual requisitions which are wrapped around an
unlabeled tube – labels are then produced in the laboratory
–A small percentage indicated that they have a combination of
labeling capabilities
•93% of EDAs report keeping a stock of pediatric
tubes on hand and 90% indicated that drawing a
specimen into a pediatric tube would not alter the
workflow process
•11% reported that they have a dedicated staff for
handling patients with chest pain complaints; the
majority rotate staff through all areas of the
department

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©2002 EAC
23Wireless technology in the EDWireless technology in the ED
•47% of ED respondents indicate they have
wireless capability in the department
–The primary applications are wireless cardiac monitoring (16)
and bedside patient registration (15)
•J&J Criticon was mentioned as a vendor, along with HP for cardiac
monitoring
–Two institutions indicated the ability to transfer glucose POC
results using wireless technology
–Two institutions said they had the technology but it wasn’t
hooked up
•15% of the POC respondents thought the ED had
wireless capability but could not describe the
systems or applications
–65% of POC coordinators indicated that if the instrument were
to be used in the ED they were prefer the connection to the
LIS be made by cable via an instrument docking station

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©2002 EAC
24
POC Testing in the Emergency DepartmentPOC Testing in the Emergency Department

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©2002 EAC
25POC testing in the Emergency DepartmentPOC testing in the Emergency Department
•Placing a POC instrument in the Emergency
Department will have considerable barriers
•Only 26 of the institutions surveyed (12%) perform
non-glucose POC testing in the ED
•Comments by participants indicate that the barriers
to acceptance include
–Existing workload of the ED staff already stretches resources
–Laboratory dominion over testing
–Lack of automated POC solutions that would handle the issues of
documentation that arise in fulfilling regulatory requirements
•Where POC testing is done, it is usually handled by
an RN or a paraprofessional (Emergency Med Tech
or Patient Care Tech)
–Blood gas testing is handled by Respiratory Therapists

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©2002 EAC
26Current POC testing performed in the EDCurrent POC testing performed in the ED
Number of Respondents:
Number of Responsdents:
ED 95 22 5 2 1
POC 112 24 7 4 0
TOTAL 207 46 12 6 1
POC Tests Performed in the ED Department
99%
22%
6%
3%
0%
0%
20%
40%
60%
80%
100%
Glucose Blood Gas Cardiac Markers Coagulation (PT,PTT)Coagulation (D-Dimer)
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©2002 EAC
27Glucose vendor representation in the EDGlucose vendor representation in the ED
Number of Respondents: Total
ED 40 28 8 5 16 81
POC 49 34 24 4 2 111
TOTAL 89 62 32 9 18 192
Instruments Used for Glucose Tests
42%
30%
15%
4%
9%
0%
20%
40%
60%
Roche LifeScan Abbott Other Don't Know
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©2002 EAC
28POC instruments in use in the ED (non-glucose)POC instruments in use in the ED (non-glucose)
Instrument Sites
Who Performs
Test
Cardiac Markers (12)
Biosite Triage 5
RN and Lab Tech
Spectral Strips 3
Roche Quick T 2
Dade Stratus 2
Blood Gas (46)
I-Stat 20
Respiratory
Therapist
ABL 70/77 5
IRMA 2
NOVA 3
Rapidlab 1
IL Co-ox 1
“Not Sure” 14

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©2002 EAC
29
Current POC testing performed in the Lab for the Current POC testing performed in the Lab for the
EDED
•POC respondents were also asked what tests
were being performed on behalf of the ED but on
POC instruments located in the lab
Test
Institutions
Using POC in
Lab
Instruments in Use
Cardiac Markers 2 Biosite Triage
Blood Gases 9
ABL70/77 (4)
I-Stat (3)
Nova (2)
Coagulation 10
Hemachron (4)
Medtronic (2)
CoaguChek (2)

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©2002 EAC
30Confidence in the resultsConfidence in the results
•EDAs were asked, “If this …instrument returns a high
critical value indicative of ischemia, which of the following
processes would you follow?”
Choices Percent
Accept and begin treatment 48%
Rerun yourself 3%
Rerun by someone else in ED 1%
Ask lab to rerun 41%
Other 6%

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©2002 EAC
31Moderately complex deviceModerately complex device
•When asked if a moderately complex POC device would be
acceptable for use in the emergency department, 61% of
the POC coordinators indicated it would be acceptable
61%
39%
Yes No

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©2002 EAC
32
ED POC Instrument Design RequirementsED POC Instrument Design Requirements

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©2002 EAC
33Comparison for specimen collectionComparison for specimen collection
Specimen Collection
42%
44%
28%
29% 29%
9%
0% 0%
56%
50%
57%
56%
33%
35%
39% 39%
2%
6%
15% 15%
38%
56%
61% 61%
0%
20%
40%
60%
80%
100%
EDPOC EDPOC EDPOC EDPOC
Cartridge Fingerstick Needle Pipette
Desirable Acceptable Not Acceptable

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©2002 EAC
34Acceptance of current Picofluor designAcceptance of current Picofluor design
Number of Respondents
POC 0 44 69
ED 0 38 59
ALL 0 82 128
Pipette Specimen Into Cuvette
39%
61%
39%
61%
39%
61%
0%
20%
40%
60%
80%
Most Desirable Acceptable Not Acceptable
POC EDAll

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©2002 EAC
35Cartridge instrument modelCartridge instrument model
Number of Respondents
POC 50 56 7
ED 41 54 2
ALL 91 110 9
Snap vacutainer into cartridge
50%
6%
56%
2%
52%
4%
44%
42%43%
0%
20%
40%
60%
80%
Most Desirable Acceptable Not Acceptable
POC EDAll

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©2002 EAC
36Use of absorbent stripsUse of absorbent strips
Number of Respondents
POC 10 40 63
ED 28 32 37
ALL 38 72 100
Residual from needle on absorbent strip
35%
56%
33%
38%
34%
48%
9%
29%
18%
0%
20%
40%
60%
80%
Most Desirable Acceptable Not Acceptable
POC EDAll

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37Use of fingerstickUse of fingerstick
Number of Respondents
POC 33 63 17
ED 27 55 15
ALL 60 118 32
Absorbent strip with fingerstick
56%
15%
57%
15%
56%
15%
29%28%29%
0%
20%
40%
60%
80%
Most Desirable Acceptable Not Acceptable
POC EDAll

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38Preferred instrument sizePreferred instrument size
•Both populations surveyed preferred a handheld instrument
for use in the ED
Instrument Size
63%
6%
26%
5%
53%
12%
14%
29%
0%
20%
40%
60%
80%
a. Handheld b.Toaster size: stationaryc. Toaster size: mobiled. In fixed monitor unit
P
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POC Responses for
Emergency Departmnet
Emergency Department
Administrator

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39Instrument size – POC responsesInstrument size – POC responses
•POC respondents chose a larger instrument if it were to be
used in the lab on behalf of the ED
Instrument Size
63%
15%
6%
54%
26%
27%
5%
0%0%
4%
0%
20%
40%
60%
80%
Used in Emergency Department Used in Laboratory
P
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a. Handheld
b.Toaster size: stationary
c. Toaster size: mobile
d. In fixed monitor unit
e. Other

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40Feature comparisonFeature comparison
•Three features considered “must have” by both populations
were the alert for critical values, patient ID shown on the
display and on-screen prompts
0% 20% 40% 60% 80% 100%
Operator ID on Screen (ED)
Operator ID on Screen (POC)
Buit-in Security Chip (ED)
Buit-in Security Chip POC)
On-screen Prompts (ED)
On-screen Prompts (POC)
Alert for Low Battery (ED)
Alert for Low Battery (POC)
Patient ID on Screen (ED)
Patient ID on Screen (POC)
Alert for Critical Values (ED)
Alert for Critical Values (POC)
Must Have Nice to Have No Value

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41Other features (POC responses for ED use)Other features (POC responses for ED use)
Question
Most Frequent
Response
Number of
Responses
Percent
Preferred Power
Source
Both power cord
and batteries
91 81%
Preferred ControlsLow and High 79 70%
Frequency of
downloading patient
data
After each
specimen
61 54%
Frequency of
downloading QC
data
Once a day 64 58%
Frequency of
Electronic QC
Once a day 48 43%
Frequency of Liquid
QC
Once a day 44 39%

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42Which lockout features do you consider essential?Which lockout features do you consider essential?
Feature Percent
QC not done 95%
Operator proficiency 81%
Incorrect patient ID 80%
Lot not changed 80%
Download not done 41%

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43Most important featuresMost important features
•In an open ended question ED administrators
indicated the three most important features were
–Alerts for critical values 33 responses
–Ability to input a patient ID 31 responses
–Accuracy and reliability of the results20 responses
•POC coordinators indicated the three most
important features were
–QC lock outs 43 responses
–Ability to input a patient ID 41 responses
–Operator ID (with lockout) 36 responses

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44
Purchasing ProcessPurchasing Process

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45
Adoption and sponsorship of a new instrument Adoption and sponsorship of a new instrument
(multiple responses were taken)(multiple responses were taken)
Who would have to sponsor
this instrument
Who would be responsible
for the adoption
ED
Responses
POC
Responses
ED
Responses
POC
Responses
Laboratory 81% 88% 64% 95%
ED
Administrator
60% 65% 44% 32%
Cardiology 49% 28% 11% 6%
Nurse
Manager
34% 24% 23% 8%
Other* 22% 19% 11% 21%
*For the ED the “Other” is primarily the ED Medical Director and for POC the “Other” is primarily the
POC Committee

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46Purchase AuthorityPurchase Authority
•At the lower price points either the ED or Laboratory would
purchase the instrument; for most institutions the
instrument becomes a capital purchase after the price
exceeds $1,000
44%
32%
13%
8%
33%
24%
14%
11%
8%
28%
53%
62%
10%
10%
16% 15%
3%
6% 5% 5%
0%
20%
40%
60%
80%
100%
Under $500 $500 - $1000 $1000 - $5000 Over $5000
Other
Shared Departments
Hospital Management
Lab Management
ED Management

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47Purchase of consumablesPurchase of consumables
•The department that purchases the consumables
may depend on interdepartmental revenue
negotiations
–62% of the ED Administrators believe that the ED will
purchase the consumables
–54% of the POC Coordinators believe that the Lab will
purchase the consumables

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48
AppendixAppendix

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49Scope & MethodologyScope & Methodology
•210 institutions were surveyed by telephone
–97 surveys were taken from ED Management (primarily ED
Administrators and ED Nurse Managers)
–113 surveys were taken from Laboratory staff – POC
coordinators
•Honoraria were paid for completion of a survey
–Each ED managers was offered $50
–Each POC Coordinator was offered $25
•Wide geographic representation
–Survey’s were completed in 49 states and the District of
Columbia; none from Hawaii
•Surveys focused on institutions doing more than
30,000 annual ED visits

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50Survey Population – US vs. Survey PopulationSurvey Population – US vs. Survey Population
Annual Visits
Representation in
US Hospital Target
Population
Representation in
Survey Hospital
Population
Under 30,000 0% 4%
30,000 – 49,999 68% 57%
50,000-69,999 22% 29%
70,000-89,999 7% 7%
90,000+ 3% 3%

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51Accountabilities of participantsAccountabilities of participants
•Respondents to the ED portion of the survey were
accountable for “administration” and the most
common titles included
–Emergency Department Administrator or Manager
–Director of Emergency Services
–Nurse Manager
•Respondents to the POC portion of the survey
were accountable for Point-of-Care testing for the
institution and the most common titles included
–POC Coordinator
–Lab Manager or Supervisor
–Director of Laboratory Services

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52Laboratory services for the Emergency DepartmentLaboratory services for the Emergency Department
•31% of ED respondents indicated they had a
dedicated STAT or Rapid Response Labs, while only
17% of POC respondents indicated they had STAT
labs
•ED respondents were later asked “If cardiac markers
are not performed on a POC instrument in the
Emergency Department, where are these tests
performed” and in this instance, 18% of respondents
indicated the tests were done in a STAT laboratory.
•In the initial question not all ED respondents were
distinguishing STAT services from the location of
those services

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53Agencies that oversee activities in the EDAgencies that oversee activities in the ED
•100% of Emergency Department respondents
indicated they were inspected by JCAHO
•82% report State involvement in regulatory issues
and inspections
•EAC did not prompt for federal involvement,
however, a small percent of respondents
mentioned EMTALA which stipulates (among
many other things):
–Individuals cannot be turned away for payment issues
–Individuals who arrive at the ED must be seen by a physician
–Individuals reporting pain must be monitored on an hourly
basis

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54Use of kits in the Emergency DepartmentUse of kits in the Emergency Department
•53% of EDAs indicated they did occult blood
testing as a kit
•43% indicated they did urine dipstick tests
•40% did urine pregnancy testing

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55Technical support for the emergency departmentTechnical support for the emergency department
93%
34%
41%
88%
16%
27%
90%
24%
33%
0%
20%
40%
60%
80%
100%
24-7 Hotline Internet connectivityOn-line training
ED POC All

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56Preferred assistance on telephone supportPreferred assistance on telephone support
73%
24%
18%
8%
77%
36%
5% 4%
75%
30%
11%
6%
0%
20%
40%
60%
80%
100%
Technical expertField Service
Tech
RN MD - Clinician
ED POC All