1602 Tech Guide Middleware

2016-02-11

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Alere Informatics

Apex Healthware LLC

Clinical Software Solutions

Charlottesville, Va
(877) 971-7953;
www.rals.com

San Antonio, Tex
(210) 757-0002;
www.apexhealthware.com

Queen Creek, Ariz
(480) 888-9447;
clin1.net

1. What is the brand name of your
company’s middleware system?

Alere remote automated laboratory system
(RALS)

Apex Connector

CLIN1 LMS

2. What is the latest version of your named
middleware system; what year was this
version first released to market?

Alere RALS-Web3 Version 5.8, 2015.

Version 5.0, 2015.

Version 1.3, 2015.

3. Specify the authorizing agency, type,
and year of the product’s regulatory
authorizations or certified compliance
with voluntary standards.

SGS ISO 13485, 2003; SGS EN ISO
13485, 2012.

n/a

n/a

4. What is the intended use or primary
function of the product?

Captures patient information, including
patient and operator ID, for testing done
at the point of care (POC), and transfers
that data to the electronic health record;
for bidirectional devices, the system can
send a wide range of information to the
device, including operator lists and device
configuration.

Interface lab instruments to laboratory
information sytems (LIS) or electronic
health records.

Laboratory analyzer and point-of-care
result processing to third-party vendors.

5. Which of the following functions or
capabilities does your middleware
system perform or support?

q automated reflex/rerun testing
q billing and reimbursement management
q communications and data validation
n data communication
q data consolidation
q orders management
q physician communication
n point-of-care data management
q quality systems management
n real-time information management
q sample and results tracking
q systems data integration
q other

q automated reflex/rerun testing
q billing and reimbursement management
q communications and data validation
n data communication
q data consolidation
q orders management
q physician communication
q point-of-care data management
q quality systems management
q real-time information management
q sample and results tracking
q systems data integration
q other

n automated reflex/rerun testing
n billing and reimbursement management
q communications and data validation
n data communication
n data consolidation
n orders management
n physician communication
n point-of-care data management
n quality systems management
n real-time information management
n sample and results tracking
n systems data integration
q other

7. On what operating system is your
middleware system based?

Windows.

Windows 7 Professional.

Windows.

8. How does your middleware support user
control and configuration?

Single-system control of POC data management; bidirectional support for applicable devices permits Alere to send certified
operators and device configurations to
connected devices; features single-system
management.

This a “black box” solution; generally
there is no user interaction once is it
configured and tested.

Includes administrative system configuration settings for user setup, with a unique
user ID and password.

9. Briefly describe any automated or
connectivity features or options that
pertain to the product.

Web-based, open connectivity for POC
testing, including direct-to-device
interfacing; connectivity is vendor-neutral
and available to leading hospital glucose
meters and many non-glucose devices;
all system functionality on one screen;
immediate and remote access to RALS
data; review and release results to the LIS
directly from units.

n/a

Interfacing for orders and results with
other vendors’ systems for facilities that
do not require a full laboratory information
system; user-friendly and easy to use;
quality solution and investment value for a
fair and reasonable cost.

10. What is the typical training time for
the product?

4 hours.

1 hour of remote Web-based training.

3 to 5 days.

11. What types of technical support are
available?

Customer support and Interfacing hours
available 7 am−7 pm ET; questions outside of business hours are relayed to an
on-call call technician responder;
questions can also be submitted online
through the Alere informatics Web site at
www.rals.com.

Monday to Friday, 8 am−5 pm CST.

24/7/365 with a service agreement.

12. What capabilities, features, or
accessories distinguish this product
from others on the market?

Multiple levels of authority to tailor system
access; at-a-glance and operator management status; flagged results require
review prior to LIS upload; integrated
operator compliance and competency
testing; ability to enter a wide range of
manual or lateral-flow test results directly
into RALS and then to the patient record.

Middleware

6. If you answered “other,” explain briefly.

24

February 2016 | clpmag.com

Recommended for the Abaxis Piccolo
when interfaced to the Sunquest LIS.

Integratable with other vendors’ systems
for immediate access to lab results;
generates barcoded labels; can also be
used as an intermediary between two or
more third-party systems (such as orders,
private health information, and results);
custom programming available.

Orchard Software Corp

Siemens Healthcare
Diagnostics Inc

Sysmex America Inc

Telcor Inc

Carmel, Ind
(800) 856-1948;
www.orchardsoft.com

Tarrytown, NY
(914) 631-8000;
siemens.com/healthcare

Lincolnshire, Ill
(800) 379-7639;
www.sysmex.com

Lincoln, Neb
(866) 489-1207;
www.telcor.com

Orchard Trellis

Siemens CentraLink data mangement
system

Sysmex WAM

Telcor QML

Version 2.0, 2012.

Version 15.0.3, 2001.

Version 5.02, 2015.

Version 2.3.16, 2015.

n/a

n/a

FDA MDDS Class 1 medical device, 2012.

ONC HIT certification, 2014.

Connecting point-of-care (POC) testing
devices to the laboratory information
system or electronic medical record.

Provides centralized management and
control of lab testing; permits customizing and streamlining workflows across
automation, systems, and information
technology to efficiently deliver timely and
accurate results.

Hematology information management
tool that consolidates data from multiple
laboratory analyzers, performs complex
rules-based functions, and communicates
this information to laboratory information
systems.

Manage point-of-care (POC) operations.

q automated reflex/rerun testing
q billing and reimbursement management
q communications and data validation
n data communication
q data consolidation
q orders management
q physician communication
n point-of-care data management
q quality systems management
q real-time information management
q sample and results tracking
n systems data integration
n other

n automated reflex/rerun testing
q billing and reimbursement management
n communications and data validation
n data communication
n data consolidation
n orders management
n physician communication
q point-of-care data management
n quality systems management
n real-time information management
n sample and results tracking
n systems data integration
n other

n automated reflex/rerun testing
q billing and reimbursement management
n communications and data validation
n data communication
n data consolidation
n orders management
q physician communication
q point-of-care data management
q quality systems management
n real-time information management
n sample and results tracking
n systems data integration
q other

q automated reflex/rerun testing
q billing and reimbursement management
n communications and data validation
n data communication
n data consolidation
q orders management
q physician communication
n point-of-care data management
q quality systems management
q real-time information management
n sample and results tracking
n systems data integration
n other

Management of personnel certification
and competency; POC quality control.

Automated clinical decision management,
hematology workflow, patient moving
averages.

Windows.

Windows 2008.

Red Hat Linux.

Windows 2008 and 2012.

System administrators create and control
testing menus, devices, and personnel
certifications.

Configurable and customizable upon
request and in alignment with laboratory
standard operating procedures.

A project manager, clinical application
consultant, and interface integration
product manager are available during
installation; on-demand e-learning and
virtual instructor-led courses; rule and
database set up to customer
configuration; consultation and ongoing
management of rules upon request.

Hundreds of user-accessible
configurations; installed on single server,
optional distributed processing across
multiple servers; optional database; high
availability.

Provides the ability to interface POC devices remotely; system administrators can
easily manage QC, personnel certification,
and POC testing menus.

Supports connectivity to Aptio automation,
third parties, and Siemens instrumentation.

Has multisite and multi-LIS capabilities;
permits subsite rules where needed for
added flexibility; manages Sysmex
automation systems in regard to rack/
smear management and sorting/archiving
of samples.

Sample ID validation via admission,
discharge, transfer, and orders interfaces;
solicited and unsolicited result interfaces;
operator interfaces to devices for operator
lockout; LMS interfaces for operator
competency and automatic recertification.

System administrator training can take
place remotely in a couple of hours.

4 hours; e-learning available.

4 hours.

Two 2-hour sessions.

Phone, e-mail, and Web support are available 24/7/365.

24/7 remote support; onsite support.

24/7 technical assistance center;
customer resource center Web site; online
help and technical document library.

24/7/365.

Rules customized to customer specifications; automated testing tools with
instrument emulator and final report
output; hematology-specific middleware
with smear and pathology management
features; fully supported middleware for
implementation and testing; system and
database management included in
product offering; onsite go live support.

Only open POC system not owned and
managed by a device vendor; first LMS
interface; single version philosophy; all
product enhancements included at no
additional cost; multiple simultaneous
result interfaces to multiple LIS and EMR
systems; multiple time zones; most connected device types; only POC middleware
with orders interface; perpetual license.

A cost-effective solution that provides
electronic connectivity to manage POC
testing; helps improve patient care and
enhance POC value by ensuring real-time
electronic capture of results in the
electronic health record, allowing
providers prompt access to results for
quick diagnosis and treatment.

Comprehensive results-management and
autoverification rules and integrated
quality control package; highly
customizable workflow scenarios;
robust and mature multidisciplinary data
management and networking system.

POC operator certification and
competency management.

clpmag.com | February 2016

25



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