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22 February 2019 | clpmag.com tech guide LIMS, LIS, Operational Middleware Abbott Laboratories Beckman Coulter Clinical Software Solutions Abbott Park, Ill (877) 422-2688 httpcorelaboratory.abbott/aliniq Brea, Calif (714) 993-5321; www.beckmancoulter.com Queen Creek, Ariz (480) 888-9447 www.clin1.net 1. What is the brand name of your company’s laboratory informa- tion management system? AlinIQ Analyzer Management System (AMS) DxOne Workflow Manager Clin1 LIS 2. What is the latest version of your named LIMS, LIS, or middleware; what year was this version first released to market? Ver 2.09; 2018 Ver 1.1; 2018 (US) Ver 11.7; 2008 (MS SQL); Ver 11.5; 1987 (Sybase) 3. Specify the authorizing agency, type, and year of the product’s regulatory authorizations or certified compliance with vol- untary standards. FDA Class 1 510(k) exempt medical device; CE mark, 2014. FDA Class I 510(k) exempt medical device N/A 4. What is the intended use or pri- mary function of the product? Middleware used as an analyzer management system Cloud-based middleware that drives efficiency with exception-based sample management, improves accessibility with a browser-based model, and increases standardiza- tion through automated workflows and integrated QC Laboratory information system 5. With which of the following systems or instruments is your system able to interface? q anatomic and digital pathology systems q bedside or handheld ID systems n blood banking q central data repositories q cytology systems q electronic medical records n hospital information systems n laboratory automation systems n microbiology instruments n molecular diagnostic instruments q pharmacy systems n point-of-care instruments q practice management and billing systems q public health surveillance systems n reference lab systems n other q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories q cytology systems n electronic medical records n hospital information systems n laboratory automation systems q microbiology instruments q molecular diagnostic instruments q pharmacy systems q point-of-care instruments q practice management and billing systems q public health surveillance systems q reference lab systems q other n anatomic and digital pathology systems n bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical records n hospital information systems n laboratory automation systems n microbiology instruments n molecular diagnostic instruments n pharmacy systems n point-of-care instruments n practice management and billing systems n public health surveillance systems n reference lab systems n other 6. On what operating system is your LIMS, LIS, or middleware based? AlinIQ AMS runs on Windows and supports Windows Server 2012 R2 for servers, and Windows 10 for workstations. The AlinIQ AMS data- base (Oracle based) can be hosted on Unix environments Cloud-based, accessed via Google Chrome (recommended), Internet Explorer 11 Windows 7. What database system does your LIMS, LIS, or middleware use? Oracle 12.1.0.2 SQL Server 2012 Standard SQL and Sybase 8. Briefly describe any automated features or options that per- tain to the product. Advanced autoverification rules; turnaround time real-time alarms; monitor transportation of samples; monitor QC data with the ability to influence the analytic process; monitor and remotely control all analyzers and automation systems; ability to perform automated tasks based on events or time Autoverification of results; auto- matic suspension of autoverifica- tion in QC out situations; batch processing of results Handles large patient databases and high sample accession rates; standard features include label printing, barcode entry, sample check-in/status, loadlists, facility default profiles, medication cor- relation, QA and QC, and ad hoc lab management reports 9. What capabilities, features, or accessories distinguish this product from others on the market? Integration of digital microscopes; real-time turnaround time monitor- ing; streamlined registration and tracking of nonconformities; real- time equipment dashboards that consolidate status information and alerts; ability to remotely view and optionally control any system Cloud-based middleware accessed via Web browser with a low total cost of ownership; intuitive modern user interface allows easy adoption Includes configurations for a variety of laboratory facility types; intuitive screens for ease and efficiency of daily tasks; QA and QC are standard features; built-in document scanning; multiwell plate processing with standard curve tracking/fitting/result interpolation; custom programming available

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Page 1: tech guide - Amazon Web Servicesa360-wp-uploads.s3.amazonaws.com/wp-content/uploads/...tech guide LIMS, LIS, Operational Middleware Abbott Laboratories Beckman Coulter Clinical Software

22 February 2019 | clpmag.com

tech guideLIMS, LIS, Operational

Middleware

Abbott Laboratories Beckman Coulter Clinical Software Solutions

Clinical Software Solutions

Comp Pro Med CompuGroup Medical Data Innovations

Abbott Park, Ill (877) 422-2688 httpcorelaboratory.abbott/aliniq

Brea, Calif (714) 993-5321; www.beckmancoulter.com

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

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

Santa Rosa, Calif (800) 276-4522www.comppromed.com

Phoenix, Ariz (800) 359-0911www.cgmus.com

Burlington, Vt (802) 658-2850www.datainnovations.com

1. What is the brand name of your company’s laboratory informa-tion management system?

AlinIQ Analyzer Management System (AMS) DxOne Workflow Manager Clin1 LIS Clin1 LMS Polytech LIS CGM Labdaq LIS Instrument Manager

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

Ver 2.09; 2018 Ver 1.1; 2018 (US) Ver 11.7; 2008 (MS SQL); Ver 11.5; 1987 (Sybase) Ver 1.3; 2015 Ver 8.6.1; 2018 Ver 18.3; 2018 Ver 8.16; 2018

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

FDA Class 1 510(k) exempt medical device; CE mark, 2014.

FDA Class I 510(k) exempt medical device N/A N/A N/A N/A

FDA Class I and Class II device, 510(k); Health Canada Class 2 device; German competent author-ity accessory to an in vitro diag-nostic, EDMA Group 27-02, GMDN 44082; CE mark; ISO

4. What is the intended use or pri-mary function of the product?

Middleware used as an analyzer management system

Cloud-based middleware that drives efficiency with exception-based sample management, improves accessibility with a browser-based model, and increases standardiza-tion through automated workflows and integrated QC

Laboratory information systemLaboratory analyzer and point-of-care results processing to third-party vendors

Laboratory information system

Laboratory information system that automates the laboratory workflow, improving turnaround times and productivity while ensuring accu-racy and patient safety

Lab enablement solutions, including analytics, connectivity, productivity, and quality solutions

5. With which of the following systems or instruments is your system able to interface?

q anatomic and digital pathology systems q bedside or handheld ID systems n blood banking q central data repositories q cytology systems q electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsq practice management and billing systems q public health surveillance systemsn reference lab systems n other

q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories q cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsq microbiology instrumentsq molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical recordsn hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems n bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical recordsn hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems q bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems q public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems q bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems q bedside or handheld ID systems n blood banking q central data repositories q cytology systems n electronic medical records n hospital information systemsq laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems n other

6. On what operating system is your LIMS, LIS, or middleware based?

AlinIQ AMS runs on Windows and supports Windows Server 2012 R2 for servers, and Windows 10 for workstations. The AlinIQ AMS data-base (Oracle based) can be hosted on Unix environments

Cloud-based, accessed via Google Chrome (recommended), Internet Explorer 11

Windows Windows Windows Windows 2012 or 2016 Server and Windows 10 Professional

Supports Windows 7 Professional (64-bit), Windows 8.1 (64-bit), Windows 10 (64-bit), Windows Server 2008 R2, standard ed (64-bit), Windows Server 2012 R2 (64-bit), and Windows Server 2016

7. What database system does your LIMS, LIS, or middleware use?

Oracle 12.1.0.2 SQL Server 2012 Standard SQL and Sybase SQL Edge Computing Oracle Cache

8. Briefly describe any automated features or options that per-tain to the product.

Advanced autoverification rules; turnaround time real-time alarms; monitor transportation of samples; monitor QC data with the ability to influence the analytic process; monitor and remotely control all analyzers and automation systems; ability to perform automated tasks based on events or time

Autoverification of results; auto-matic suspension of autoverifica-tion in QC out situations; batch processing of results

Handles large patient databases and high sample accession rates; standard features include label printing, barcode entry, sample check-in/status, loadlists, facility default profiles, medication cor-relation, QA and QC, and ad hoc lab management reports

Interfacing for orders and results with other vendors’ EHR/EMR systems for facilities that do not require a full laboratory informa-tion system; easy-to-use intuitive screens; sample detail and tracking; administration management func-tions

Automatic result verification; auto-matic abnormal result flagging; automatic recall of patient demo-graphics; automatic sample ID gen-eration; automatic barcode printing; automatic report transmission via secure fax, email, or Web server

Supports automated results deliv-ery via EMR interfaces, Web portal, fax, or e-mail. User-defined rules include autoverification, billing rules, reflexing, and order routing to the appropriate lab. Hundreds of reports and dashboards are avail-able for business analytics

Delivers end-to-end lab enablement solutions to help drive automation and efficiency throughout the lab, including autoverification, mov-ing averages for quality control, integrated daily and peer QC, and proficiency test reporting

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

Integration of digital microscopes; real-time turnaround time monitor-ing; streamlined registration and tracking of nonconformities; real-time equipment dashboards that consolidate status information and alerts; ability to remotely view and optionally control any system

Cloud-based middleware accessed via Web browser with a low total cost of ownership; intuitive modern user interface allows easy adoption

Includes configurations for a variety of laboratory facility types; intuitive screens for ease and efficiency of daily tasks; QA and QC are standard features; built-in document scanning; multiwell plate processing with standard curve tracking/fitting/result interpolation; custom programming available

Easy-to-use screens lower barriers to data collection and review; built-in management reports; integrat-able with other vendors’ systems for immediate access to lab results; custom programming available

Zero downtime system, built on the most advanced technology in the industry; no server to buy and maintain; no data loss; low total cost of ownership and quick return on investment; installed and run-ning in a matter of weeks

Highly configurable, scalable, and intuitive; consolidates in-house and reference lab results; many features improve efficiencies, including inte-gration with EMR, billing and refer-ence labs, workflow management, specimen storage, inventory mod-ule for consumables and reagents, and document management

Instrument Manager enables enter-prise management of hospital and independent laboratories, building efficiency and optimization across all disciplines so that staff can focus on what matters most

CLP_02_p22-29_Tech_LIMS 2[1]+SDH edits_3.indd 22 2/8/19 1:19 PM

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clpmag.com | February 2019 23

Abbott Laboratories Beckman Coulter Clinical Software Solutions

Clinical Software Solutions

Comp Pro Med CompuGroup Medical Data Innovations

Abbott Park, Ill (877) 422-2688 httpcorelaboratory.abbott/aliniq

Brea, Calif (714) 993-5321; www.beckmancoulter.com

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

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

Santa Rosa, Calif (800) 276-4522www.comppromed.com

Phoenix, Ariz (800) 359-0911www.cgmus.com

Burlington, Vt (802) 658-2850www.datainnovations.com

1. What is the brand name of your company’s laboratory informa-tion management system?

AlinIQ Analyzer Management System (AMS) DxOne Workflow Manager Clin1 LIS Clin1 LMS Polytech LIS CGM Labdaq LIS Instrument Manager

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

Ver 2.09; 2018 Ver 1.1; 2018 (US) Ver 11.7; 2008 (MS SQL); Ver 11.5; 1987 (Sybase) Ver 1.3; 2015 Ver 8.6.1; 2018 Ver 18.3; 2018 Ver 8.16; 2018

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

FDA Class 1 510(k) exempt medical device; CE mark, 2014.

FDA Class I 510(k) exempt medical device N/A N/A N/A N/A

FDA Class I and Class II device, 510(k); Health Canada Class 2 device; German competent author-ity accessory to an in vitro diag-nostic, EDMA Group 27-02, GMDN 44082; CE mark; ISO

4. What is the intended use or pri-mary function of the product?

Middleware used as an analyzer management system

Cloud-based middleware that drives efficiency with exception-based sample management, improves accessibility with a browser-based model, and increases standardiza-tion through automated workflows and integrated QC

Laboratory information systemLaboratory analyzer and point-of-care results processing to third-party vendors

Laboratory information system

Laboratory information system that automates the laboratory workflow, improving turnaround times and productivity while ensuring accu-racy and patient safety

Lab enablement solutions, including analytics, connectivity, productivity, and quality solutions

5. With which of the following systems or instruments is your system able to interface?

q anatomic and digital pathology systems q bedside or handheld ID systems n blood banking q central data repositories q cytology systems q electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsq practice management and billing systems q public health surveillance systemsn reference lab systems n other

q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories q cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsq microbiology instrumentsq molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical recordsn hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems n bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical recordsn hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems q bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems q public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems q bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems q bedside or handheld ID systems n blood banking q central data repositories q cytology systems n electronic medical records n hospital information systemsq laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems n other

6. On what operating system is your LIMS, LIS, or middleware based?

AlinIQ AMS runs on Windows and supports Windows Server 2012 R2 for servers, and Windows 10 for workstations. The AlinIQ AMS data-base (Oracle based) can be hosted on Unix environments

Cloud-based, accessed via Google Chrome (recommended), Internet Explorer 11

Windows Windows Windows Windows 2012 or 2016 Server and Windows 10 Professional

Supports Windows 7 Professional (64-bit), Windows 8.1 (64-bit), Windows 10 (64-bit), Windows Server 2008 R2, standard ed (64-bit), Windows Server 2012 R2 (64-bit), and Windows Server 2016

7. What database system does your LIMS, LIS, or middleware use?

Oracle 12.1.0.2 SQL Server 2012 Standard SQL and Sybase SQL Edge Computing Oracle Cache

8. Briefly describe any automated features or options that per-tain to the product.

Advanced autoverification rules; turnaround time real-time alarms; monitor transportation of samples; monitor QC data with the ability to influence the analytic process; monitor and remotely control all analyzers and automation systems; ability to perform automated tasks based on events or time

Autoverification of results; auto-matic suspension of autoverifica-tion in QC out situations; batch processing of results

Handles large patient databases and high sample accession rates; standard features include label printing, barcode entry, sample check-in/status, loadlists, facility default profiles, medication cor-relation, QA and QC, and ad hoc lab management reports

Interfacing for orders and results with other vendors’ EHR/EMR systems for facilities that do not require a full laboratory informa-tion system; easy-to-use intuitive screens; sample detail and tracking; administration management func-tions

Automatic result verification; auto-matic abnormal result flagging; automatic recall of patient demo-graphics; automatic sample ID gen-eration; automatic barcode printing; automatic report transmission via secure fax, email, or Web server

Supports automated results deliv-ery via EMR interfaces, Web portal, fax, or e-mail. User-defined rules include autoverification, billing rules, reflexing, and order routing to the appropriate lab. Hundreds of reports and dashboards are avail-able for business analytics

Delivers end-to-end lab enablement solutions to help drive automation and efficiency throughout the lab, including autoverification, mov-ing averages for quality control, integrated daily and peer QC, and proficiency test reporting

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

Integration of digital microscopes; real-time turnaround time monitor-ing; streamlined registration and tracking of nonconformities; real-time equipment dashboards that consolidate status information and alerts; ability to remotely view and optionally control any system

Cloud-based middleware accessed via Web browser with a low total cost of ownership; intuitive modern user interface allows easy adoption

Includes configurations for a variety of laboratory facility types; intuitive screens for ease and efficiency of daily tasks; QA and QC are standard features; built-in document scanning; multiwell plate processing with standard curve tracking/fitting/result interpolation; custom programming available

Easy-to-use screens lower barriers to data collection and review; built-in management reports; integrat-able with other vendors’ systems for immediate access to lab results; custom programming available

Zero downtime system, built on the most advanced technology in the industry; no server to buy and maintain; no data loss; low total cost of ownership and quick return on investment; installed and run-ning in a matter of weeks

Highly configurable, scalable, and intuitive; consolidates in-house and reference lab results; many features improve efficiencies, including inte-gration with EMR, billing and refer-ence labs, workflow management, specimen storage, inventory mod-ule for consumables and reagents, and document management

Instrument Manager enables enter-prise management of hospital and independent laboratories, building efficiency and optimization across all disciplines so that staff can focus on what matters most

CLP_02_p22-29_Tech_LIMS 2[1]+SDH edits_3.indd 23 2/8/19 1:19 PM

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24 February 2019 | clpmag.com

Dataworks Development NovoPath Orchard Software

Mountlake Terrace, Wash (877) 289-7960www.freezerworks.com

Princeton, NJ (877) 668-6123www.novopath.com

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

1. What is the brand name of your company’s laboratory informa-tion management system?

Freezerworks NovoPath AP/CP LIS Orchard Harvest LIS

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

Ver 10.1; 2018 Ver 9.0 R10; 2018 Ver 11; 1994

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

N/AONC HIT certification, 2014; Gold Microsoft Partner; FDA 21 CFR Part II certification

ONC HIT EHR module certification, 2015; ONC HIT certification, 2018

4. What is the intended use or pri-mary function of the product?

Provides configurable sample and study management solutions to large- and small-scale organizations

Laboratory information manage-ment system Laboratory information system

5. With which of the following systems or instruments is your system able to interface?

q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking n central data repositories q cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsq molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instruments n practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

6. On what operating system is your LIMS, LIS, or middleware based?

Windows, Mac Windows, Web Browser Windows

7. What database system does your LIMS, LIS, or middleware use?

4th Dimension SQL 4th Dimension

8. Briefly describe any automated features or options that per-tain to the product.

Supports clinical trials with patient enrollment, kit creation, study con-figuration, and visit modeling capa-bilities. Workflow templates reduce time needed for important tasks such as QC check, check in, check out, and sample requests

Automates the entire testing pro-cess, including specimen ordering and routing; patient, insurance and physician data entry; specimen grossing; diagnosis and synoptic data entry; case auditing; report delivery; specimen tracking; and Lean process mapping

Supports automated result delivery, synoptic data mining, business analytics, and rules-based decision support technology

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

Freezerworks is flexible and user-friendly, with a broad set of security features, 21 CFR part 11 compli-ance support, and cryogenic-safe barcode labeling

An advanced, robust, modular LIS; the lab purchases only what is needed; affordable, multilingual, intuitive, and user-friendly modules for cytogenetics, flow cytometry, merit-based incentive payment system, molecular; customizable, easily developed interfaces to third-party vendors; rules-based staff scheduler; Lean process support; business intelligence dashboard widgets, mobile apps

Includes features capable of han-dling a variety of lab workflows and business situations such as support for business intelligence, integra-tion, microbiology, pathology, POC testing, PPID, QA and QC support, sample tracking, user-defined rules, and workflow management

Robust & Easy to Use Software

CONTACT US TODAY www.CLIN1.net

Includes Laboratory Tools

Laboratory Information System

Lab Software for Every Environment Function Based Technology HL7 Interface Capabilities

Clinical, Molecular Diagnostics, Toxicology, Micro, Pathology, Histology, Veterinary

Unique Solutions

We offer unique options for small facilities needing EHR connectivity or specialized labs with custom multi-well

processes, proprietary research or data manipulation needs.

Lab Management Quality Control

Unlimited Controls & Levels, Levy-Jennings Plots On Demand,

Linearity Tracking, Standard Curves Manual Data Entry or Device Interfaces Six Sigma Support for the Laboratory

Lab Monitoring Quality Assurance

Log Incidents & Follow-up Actions, Create Lab Staff To-Do Items,

Track Device Events & Maintenance, Add Document Support for Inspections

tech guideLIMS, LIS, Operational

Middleware

CLP_02_p22-29_Tech_LIMS 2[1]+SDH edits_3.indd 24 2/8/19 1:19 PM

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26 February 2019 | clpmag.com

Orchard Software Orchard Software Psyche Systems SCC Soft Computer Schuyler House Siemens Healthineers Sunquest Information Systems

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

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

Milford, Mass (508) 473-1500; www.psychesystems.com

Clearwater, Fla (800) 763-8352; www.softcomputer.com

Valencia, Calif (800) 706-0266; www.schuylab.com

Tarrytown, NY www.siemens.com/healthineers

Tucson, Ariz (520) 570-2000; www.sunquestinfo.com

1. What is the brand name of your company’s laboratory informa-tion management system?

Orchard Trellis Orchard Sequoia WindoPath SoftLab LIS Suite SchuyLab Atellica Data Manager Sunquest Laboratory

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

Ver 1.0; 2017 In beta testing Ver 8.4; 2014 Ver 4.x; 2018 Ver 3.3.5 Ver 1.0; 2018 Ver 8.2; 2019

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

N/A N/A Meaningful use certification

FDA Class I and Class II (blood banking) 510(k); ONC HIT 2015 ed certification; ISO/MDSAP service capability and performance stand-ards certification

N/A N/A FDA 510(k); ONC HIT certification, 2015

4. What is the intended use or pri-mary function of the product?

Point-of-care testing integration and management system Laboratory information system

Stores patient demographics and history and sends results to pathol-ogists

Laboratory automation Laboratory information system Laboratory middleware

Automates and drives the clinical lab workflow; streamlines lab processes to reduce specimen han-dling time, increase productivity, and improve turnaround time

5. With which of the following systems or instruments is your system able to interface?

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsn practice management and billing systems q public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems n reference lab systems n other

q anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories q cytology systems q electronic medical records q hospital information systemsn laboratory automation systemsq microbiology instrumentsq molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems n other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

6. On what operating system is your LIMS, LIS, or middleware based?

Windows Windows Windows Server 2008 to current version Linux, AIX

Windows Vista, Vista Business, Windows 7, Windows 8, Windows 10

Windows Server 2012 R2Windows 2010 R2 SP1 or 2012 R2; IBM AIX 7.1 or RHEL 7; Windows Server 2016

7. What database system does your LIMS, LIS, or middleware use?

SQL SQL SQL Server Oracle FairCom C-Tree and Pervasive Btrieve Progress OpenEdge Intersystems Cache 2014 1.5 Build

851_3

8. Briefly describe any automated features or options that per-tain to the product.

Provides the ability to remotely interface POC testing devices; sys-tem administrators can easily man-age POC testing menus, QC, and personnel certification

Offers maximum flexibility and configurability to support unique workflows across various labora-tory scenarios; can assist with lab requirements, from interfacing to automation lines to remote point-of-care testing

Scheduled reporting

Fully automated system, including autoverification, auto-test-routing, workstation redirection, rules engine, workflow engine, specimen tracking (chain-of-custody), billing rules, storage and retrieval auto-mation, blood bank unit dispensing, and advanced integration with lab robotics

Offers many automated features via optional modules, including auto-verification, review results, reflex, auto remarks, and conditional calculations

Offers powerful features to auto-mate laboratory testing processes, autoverify results, and automate continuous and proactive QC mon-itoring

Specimen management routing and tracking (SMART) module; clinical validation module; integration with Sunquest Collect; integration with Sunquest Blood Bank with electron-ic crossmatch, designed to work seamlessly with Data Innovations solutions

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

A POC testing management and integration software solution that provides remote administration of all POC testing activities across multiple locations, including device and operator competency assess-ment tracking. Transmits POC testing results to the LIS and EHR, reducing manual entry errors and automating billing for POC test-ing. Offers a high level of flexibility for various POC testing scenarios, helping providers to make faster clinical decisions, include POC test-ing results in analytics, and promote patient satisfaction

An enterprise-class laboratory information system that incorpo-rates advanced tools and decision support to measure performance, improve productivity, and gener-ate valuable business analytics; designed to support high-volume, complex laboratories

WindoPath is customizable to meet clients’ lab testing requirements

Next-gen LIS platform with fully integrated blood bank, genetics, LIS, and pathology modules. Seamless specimen management and chain-of-custody. Embedded proto-col (workflow) designer with rules engine for optimized workflows and enforcement of protocols

Easy-to-use laboratory information system that improves staff abil-ity to perform routine laboratory tasks at a high rate of efficiency and accuracy; integrated software that provides a variety of options for results delivery, management, overview, and billing process pro-cedures

Easy-to-use autoverification rules wizard and extensive rules library; iExpert procedural tool; compre-hensive QC management system including patient moving averages, advanced workflows for laboratory automation, and open connectivity

Multilab location support; clinical validation module uses highly configurable rules to queue tests requiring further review automati-cally; blood bank module features a new emergency release function to manage units during critical moments within the lab

tech guideLIMS, LIS, Operational

Middleware

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clpmag.com | February 2019 27

Orchard Software Orchard Software Psyche Systems SCC Soft Computer Schuyler House Siemens Healthineers Sunquest Information Systems

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

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

Milford, Mass (508) 473-1500; www.psychesystems.com

Clearwater, Fla (800) 763-8352; www.softcomputer.com

Valencia, Calif (800) 706-0266; www.schuylab.com

Tarrytown, NY www.siemens.com/healthineers

Tucson, Ariz (520) 570-2000; www.sunquestinfo.com

1. What is the brand name of your company’s laboratory informa-tion management system?

Orchard Trellis Orchard Sequoia WindoPath SoftLab LIS Suite SchuyLab Atellica Data Manager Sunquest Laboratory

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

Ver 1.0; 2017 In beta testing Ver 8.4; 2014 Ver 4.x; 2018 Ver 3.3.5 Ver 1.0; 2018 Ver 8.2; 2019

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

N/A N/A Meaningful use certification

FDA Class I and Class II (blood banking) 510(k); ONC HIT 2015 ed certification; ISO/MDSAP service capability and performance stand-ards certification

N/A N/A FDA 510(k); ONC HIT certification, 2015

4. What is the intended use or pri-mary function of the product?

Point-of-care testing integration and management system Laboratory information system

Stores patient demographics and history and sends results to pathol-ogists

Laboratory automation Laboratory information system Laboratory middleware

Automates and drives the clinical lab workflow; streamlines lab processes to reduce specimen han-dling time, increase productivity, and improve turnaround time

5. With which of the following systems or instruments is your system able to interface?

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsn practice management and billing systems q public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems n reference lab systems n other

q anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking q central data repositories q cytology systems q electronic medical records q hospital information systemsn laboratory automation systemsq microbiology instrumentsq molecular diagnostic instrumentsq pharmacy systemsq point-of-care instrumentsq practice management and billing systems q public health surveillance systems q reference lab systems n other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical records n hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsn pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

6. On what operating system is your LIMS, LIS, or middleware based?

Windows Windows Windows Server 2008 to current version Linux, AIX

Windows Vista, Vista Business, Windows 7, Windows 8, Windows 10

Windows Server 2012 R2Windows 2010 R2 SP1 or 2012 R2; IBM AIX 7.1 or RHEL 7; Windows Server 2016

7. What database system does your LIMS, LIS, or middleware use?

SQL SQL SQL Server Oracle FairCom C-Tree and Pervasive Btrieve Progress OpenEdge Intersystems Cache 2014 1.5 Build

851_3

8. Briefly describe any automated features or options that per-tain to the product.

Provides the ability to remotely interface POC testing devices; sys-tem administrators can easily man-age POC testing menus, QC, and personnel certification

Offers maximum flexibility and configurability to support unique workflows across various labora-tory scenarios; can assist with lab requirements, from interfacing to automation lines to remote point-of-care testing

Scheduled reporting

Fully automated system, including autoverification, auto-test-routing, workstation redirection, rules engine, workflow engine, specimen tracking (chain-of-custody), billing rules, storage and retrieval auto-mation, blood bank unit dispensing, and advanced integration with lab robotics

Offers many automated features via optional modules, including auto-verification, review results, reflex, auto remarks, and conditional calculations

Offers powerful features to auto-mate laboratory testing processes, autoverify results, and automate continuous and proactive QC mon-itoring

Specimen management routing and tracking (SMART) module; clinical validation module; integration with Sunquest Collect; integration with Sunquest Blood Bank with electron-ic crossmatch, designed to work seamlessly with Data Innovations solutions

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

A POC testing management and integration software solution that provides remote administration of all POC testing activities across multiple locations, including device and operator competency assess-ment tracking. Transmits POC testing results to the LIS and EHR, reducing manual entry errors and automating billing for POC test-ing. Offers a high level of flexibility for various POC testing scenarios, helping providers to make faster clinical decisions, include POC test-ing results in analytics, and promote patient satisfaction

An enterprise-class laboratory information system that incorpo-rates advanced tools and decision support to measure performance, improve productivity, and gener-ate valuable business analytics; designed to support high-volume, complex laboratories

WindoPath is customizable to meet clients’ lab testing requirements

Next-gen LIS platform with fully integrated blood bank, genetics, LIS, and pathology modules. Seamless specimen management and chain-of-custody. Embedded proto-col (workflow) designer with rules engine for optimized workflows and enforcement of protocols

Easy-to-use laboratory information system that improves staff abil-ity to perform routine laboratory tasks at a high rate of efficiency and accuracy; integrated software that provides a variety of options for results delivery, management, overview, and billing process pro-cedures

Easy-to-use autoverification rules wizard and extensive rules library; iExpert procedural tool; compre-hensive QC management system including patient moving averages, advanced workflows for laboratory automation, and open connectivity

Multilab location support; clinical validation module uses highly configurable rules to queue tests requiring further review automati-cally; blood bank module features a new emergency release function to manage units during critical moments within the lab

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28 February 2019 | clpmag.com

Upcoming Tech GuidesEach month, CLP invites IVD manufacturers and clinical laboratory

suppliers to complete a standardized topic-specific questionnaire

highlighting their products.

• Microbiology Systems • Urinalysis systems and assays• Clinical chemistry and integrated analyzers and assays • Immunoassay kits and analyzers • Anatomic and digital pathology instruments and tools

PREVIEW OF TOPICS

To be considered for inclusion, contact chief editor Steve Halasey via [email protected]

CLP_TechGuide_full.indd 1 1/16/19 8:21 AM

Sysmex America Technidata Telcor Xifin

Lincolnshire, Ill (224) 543-9307

Montréal, Québec, Canada (855) 550-5705www.technidata-web.com

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

San Diego (858) 436-9533 www.xifin.com

Sysmex WAMLivextens Suite (includes TDBactiLink, TDBioBank, TDHistoCyto, and TDNexLabs )

Telcor QML Xifin LIS 5.0

Ver 5.0.2 Ver V01.31A; 2018 Ver 2.3.28; 1999 Ver 5; 2018

FDA 510(k), 2007 FDA Class 1 510(k) FDA Class I exempt medical device SOC1, SOC2, CAP, CLIA

A modular work area management (WAM) system for data processing; acts as an independent data man-agement system that interfaces with multiple disciplines and the laboratory information system; improves operational efficiencies through comprehensive data man-agement to improve workflows and eliminate manual steps

Improves quality of care provided to patients, and the performance and profitability of the lab organ-ization

Manages information systems for a point-of-care testing program, encompassing devices, operators, and results; interfaces with host systems such as ADT, LMS, Orders, and Results

Laboratory information system for anatomic pathology, clinical pathology, clinical trials, molecu-lar, next-generation sequencing, toxicology

q anatomic and digital pathology systems q bedside or handheld ID systems q blood banking n central data repositories q cytology systems q electronic medical records q hospital information systemsn laboratory automation systemsq microbiology instrumentsq molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsq practice management and billing systems q public health surveillance systems n reference lab systems q other

n anatomic and digital pathology systems n bedside or handheld ID systems n blood banking n central data repositories n cytology systems n electronic medical recordsn hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems n other

q anatomic and digital pathology systems n bedside or handheld ID systems q blood banking n central data repositories q cytology systems n electronic medical records n hospital information systemsq laboratory automation systemsq microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsq practice management and billing systems q public health surveillance systems n reference lab systems n other

n anatomic and digital pathology systems q bedside or handheld ID systems q blood banking n central data repositories n cytology systems n electronic medical recordsn hospital information systemsn laboratory automation systemsn microbiology instrumentsn molecular diagnostic instrumentsq pharmacy systemsn point-of-care instrumentsn practice management and billing systems n public health surveillance systems n reference lab systems q other

RedHat Linux ES 6.2 Windows Windows Server 2016Cloud-based system accessed via standard Web browsers (Chrome, Firefox, Internet Explorer, etc)

Oracle Oracle or SQL Server Sybase SQL Anywhere and SQL Express/SQL Server for transac-tional data

SQL

Automation of rules testing, valida-tion of results, transportation of samples, addition of comments/flags

Offers expert rules engine at all workflow steps; integration with lab automation systems for bio-chemistry or microbiology; push information systems (counters, dashboard, SMS/email alerts)

Sample ID validation via ADT and orders interfaces; solicited and unsolicited result interfaces; oper-ator interfaces to devices for oper-ator lockout; learning management system interfaces for operator competency and automatic recer-tification

Integration with medical devices allows for automated integration of results; system can be configured to auto-release normal results; batch processing (accessioning, instrumentation, results) allows for a more streamlined workflow

Automation of rules testing, com-prehensive rules library for hema-tology and urinalysis disciplines

Provides laboratories and biore-positories with software manage-ment solutions that adjust to the needs of all disciplines (anatomic pathology, biobanking, biology, genetics, microbiology); multisite capabilities, easy integration, full traceability, customization, compli-ance with regulatory requirements

An open POC testing system with an LMS interface; product enhancements at no additional cost; multiple simultaneous result interfaces to multiple LIS/EMR systems for solicited/unsolicited results; multiple ADT and orders interface options; perpetual license

A cost-effective Web-based SaaS platform; no major hardware or software purchases or upgrade fees; tailored modules and log-ic-driven reports, including sum-mary and TCPC reporting

CLP_02_p22-29_Tech_LIMS 2[1]+SDH edits_3.indd 28 2/8/19 1:19 PM