|
To advance
to a particular topic from this meeting review, please click on one of
the links below:
Point-of-Care
(POC) Data Management
What
constitutes
CIC compliance?
What
is
“Wireless” in POCT?
Data
Management Systems |
"One
Year After Sunset"
A
Look at Point of Care Data
and Instrument Management
After the CIC
A Review
of the July 9, 2002 Meeting
Purpose
-
Demystify
work performed by CIC (Connectivity Industry Consortium)
-
Learn about
open data management for POCT
-
Assist in
decision making for purchase of data management systems
-
Advantages
of RALS-Plus
Point-of-Care
(POC) Data Management
History
-
POC data
management started as a process where all tests were documented on
paper and an audit trail was followed through manual filing.
-
The
“Sneaker Net” was then designed where technical personnel were
sent to patient care areas (in their sneakers) to download
information with a laptop or personal computer. Data was
sorted in the computer.
-
Basic
connectivity allowed the retirement of sneakers by the advance of
downloading and uploading data through a modem or network.
Data was sent from each patient care area to a main computer,
generally in the POCT Coordinator’s office.
-
The next
advancement brought a connection of the main computer (in the
coordinator’s office) with the Laboratory Information System
(LIS).
-
Subsequently,
the need is for a multi-analyte and enterprise-wide solution with
full, bi-directional device integration and full ADT and LIS
integration for all POC tests.
Connectivity
Industry Consortium (CIC)
-
The CIC was
formed (February 2000) in response to the need to develop a standard
for POCT connectivity so each vendor did not need to reinvent the
wheel for POCT instrument communication to LIS and HIS.
-
This group
was composed of personnel from vendors, suppliers, and hospitals
located in the United States. Participation was voluntary.
-
The
participants designed a set of standards that should provide a
universal solution to the multi-vendor problem of POCT connectivity.
-
Compliance
with the CIC standards in voluntary.
Back
to top
What
constitutes CIC compliance?
CIC compliance
requires only Health Level 7 (HL7) LIS interface (from data manager computer
to LIS).
CIC Defined Four
Components and Three Data Protocols of POCT (the following are CIC
recommendations)
The four components
are: (1) Testing Devices, (2) Access Points, (3) Data Management
Systems, and (4) Clinical Information Systems.
The three data
protocols link the four components: (1) device and access point
specifications, (2) device messaging and layer specifications, and (3)
observation reporting interface specifications.
-
Testing Devices:
any device, instrument, analyzer (handheld or benchtop) used for POCT.
-
Device and Access
Point Specifications: (POCT1-A – DAP Spec)
-
This refers
to the basic ability of the device to communicate.
-
It is the
language for devices and Local Area Network (LAN) accessing
-
CIC specified
that each device should follow the protocol of the IrDA (Infrared Data
Association). Each device should be able to communicate through
cables or InfraRed wireless.
-
Each device
should be able to identify itself by using IEEE Std 1073 (for medical
devices) to a specific data manager.
-
Self-identification
should allow multiple devices to share one network.
-
Access Points: refers to the data and the network sending the
data
-
Device Messaging Layering Specifications: (POCT1-A – DML Spec)
-
These call
for two channels, where one is automatically configured in each device
by every vendor, and one is vendor defined:
-
The first
channel includes: POCT1-A device identification, serial number,
date, time, operator ID, QC lot number, strip or cassette lot
number, patient ID, test results, and comments codes/corrective
action.
-
The
second channel is determined by the vendor and allows the vendor
to remain competitive. These options include: device
configuration (global or unique – clock, volume, alerts, etc.),
lockout management (patient, operator, QC), reagent and QC
formatting, remote operation or management, auto-calibration,
firmware updates and/or upgrades.
-
If every
vendor adopts POCT1-A, then…
-
Devices will
be “plug and play”
-
Only CIC
standard data is assured
-
Technology
differentiation will persist
-
Competitive
differentiation will persist
-
Alliances/partnerships
will flourish
-
“Work-arounds”
will not be required
Back
to top
What
is “Wireless” in POCT?
-
CIC did not
specify any new technology and, therefore, did not recommend that devices
should be wireless.
-
Wireless ethernet
which transmits data at 10x106 bits per second (bps) is currently existing
and in use as nonlicensed ISM bands. These Industrial (26.0 MHz),
Scientific (83.5 MHz) and Medical (125.0MHz) bands do not have to be
registered with the FCC and are reserved for public use. In general,
the higher the frequency, the greater the bandwidth, the faster data can
be transmitted. The disadvantage to this technology is that
interference with multiple users can occur.
-
Spread
SpectrumTechnology:
Narrow Band
-
Used by
radio, TV, 2-way radios.
-
Licensed by
FCC to ensure that no other users in the local area broadcast through
the same frequency.
-
Expensive for
licensing
-
Approximately
17 mile radius
Unlicensed Spread
Spectrum
-
No license
needed
-
ISM bands
InfraRed
-
No license
needed
-
But does need
an unobscured line of sight communication
-
These are
currently available: SureStep, iStat, PDAs
-
“Point and
Squirt”
“Real time”
testing devices to come! These will still require management and review.
These devices will be tightly regulated.
Back
to top
Data
Management Systems
Refers to the
computer that the device downloads to. Medical Automation Systems (MAS)
is the company that developed RALS.
MAS history:
-
1994:
Founded company based on RALS technology developed at UVA.
-
1995:
launched RALS for blood gases. Vendor independent.
-
1996:
developed RALS-G for glucose testing. Device specific product.
-
1998:
co-marketing agreement w/ Roche Diagnostics.
-
1999:
launched RALS-Link, RALS-LIS, RALS-ADT and LabScheduler. Charter and
founding member of CIC
-
2000:
Launched TIARA
-
2001:
Re-gained vendor independent position. Launched RALS-Plus.
RALS-G: (1996)
-
Roche wanted to
connect their glucose meters to eliminate “sneaker net”
-
Design based on
GTS/HDM data protocols
-
LIS interface was
an added benefit to Roche
-
Classic
vendor/device specific data mgmnt.
-
State-of-the-art
for it’s time
MAS vision:
-
Optimize the
potential for customers to achieve regulatory compliance and generate
revenue while improving efficiency and containing cost.
-
To be universally
recognized as the optimum information management solution for hospital
POCT.
RALS Plus (2001)
The rest of the
discussion focused on a brief overview of the user screens available on
RALS-Plus
Back
to top |
Previous
SoCal
Meeting
Recaps
October
16, 2001
June
19, 2001
February
27, 2001
September
16, 2000
June
20, 2000
POCC Directory
Test Grid
|
