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Name
Name of instrument/First year sold in U.S.
List price/Total No. sold in 2011
Number of units in clinical use in U.S./Outside U.S.
Where designed/Manufactured/Where reagents manufactured
Operational type/Reagent type
Sample handling system/Model type
Dimensions in inches (H x W x D)/Footprint in square feet
Number of tests for which analyzer has FDA-cleared applications
Tests released for clinical use in last 12 months
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Research-use-only assays
Tests in development
Methodologies supported/immunoassay methodologies
Number of direct ion-selective electrode channels
Number of different measured assays onboard simultaneously
Number of different assays programmed and calibrated at once
Number of user-definable (open) channels/Number active simultaneously
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set
Walkaway capacity in minutes/Specimens/Tests or assays
Uses disposable cuvettes/Maximum number stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability/Autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures number of tests remaining/Short sample detection/Clot detection
Hemolysis/Turbidity detection-quantitation
Sample volume can be reduced
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Therapeutic drugs/Drugs of abuse
Automatic shutdown programmable/Startup programmable
Stat time to completion of all analytes and throughput per hour for:
• Sodium, potassium, chloride, TC02
• Sodium, potassium, chloride, TC02, glucose, urea, creatinine
• Albumin, direct and total bilirubin, AST, ALT, ALP
Typical time delay from ordering stat test to aspiration of sample
How often QC required/Onboard SW capability to review QC
Onboard real-time QC/Support multiple QC lot numbers per analyte
System can automatically transfer QC results to LIS
Data management capability/Instrument vendor supplies LIS interface
Interfaces to what LISs up and running in active user sites
Bidirectional interface capability
Uses LOINC to transmit orders and results across interface
How labs get LOINC codes for reagent kits
Interface available (or will be) to automated specimen-handling system
Modem servicing available/System can diagnose own malfunctions/System can determine malfunctioning component
On-site time of service engineer
Mean time between failures/Mean time to repair failures
Average time to complete maintenance by lab personnel
Onboard maintenance records/Maintenance training demo module
Training provided with instrument purchase
Distinguishing features (provided by vendor)
Shortest/Median onboard reagent stability/Refrigerated onboard
Multiple reagent configurations supported
Reagent container placed directly on system for use
Instrument has same capabilities when third-party reagents used
Name of instrument/First year sold/Where designed
Country where manufactured/Where reagents manufactured
No. of units in clinical use in U.S./Outside U.S.
Operational type/Model type/Sample handling system
Dimensions in inches (H × W × D)/Instrument footprint in sq. feet
Tests available on instrument in U.S.
Tests not available in U.S. but available in other countries
Tests not available in U.S. but submitted for clearance
Tests in development
Tests not available on other manufacturers’ analyzers
Fully automated microplate system
Number of each analyte performed in separate disposable unit
Number of wells in microplate
Methods supported/Separation methods
Number of different measured assays onboard simultaneously
Number of different assays programmed, calibrated at once
Number of user-definable (open) channels
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set
Shortest/Median onboard reagent stability/Refrigerated onboard
Multiple reagent configurations supported
Reagent container placed directly on system for use
Reagents bar coded/Information in bar code
Same capabilities when 3rd-party reagents used/Susceptibility to carryover
Walkaway capacity in minutes/Specimens/Tests-assays
System is open (home-brew methods can be used)/Liquid or dry system
Uses disposable cuvettes/Maximum number stored
Uses washable cuvettes/Replacement frequency
Minimum specimen volume required
Minimum sample vol. aspirated precisely at once/Minimum dead volume
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption
Noise generated
Has dedicated pediatric sample cup/Dead volume
Bar-code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures No. of tests remaining/Short sample detection
Clot detection/Reflex testing capability
Hemolysis detection-quantitation/Turbidity detection-quantitation
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results
Time between initial result and reaspiration of sample for rerun
Autocalibration or autocalibration alert
Number of calibrators required for each analyte
Calibrants can be stored onboard/Average calibration frequency
Multipoint calib. supported/Multiple calibs. stored for same assay
How often QC required
Onboard real-time QC/Support multiple QC lot Nos. per analyte
Automatic shutdown/Startup is programmable/Startup time
Stat time to completion of β-hCG test
Time delay from ordering stat test to aspiration of sample
Throughput per hour for three analytes on each specimen, in No. of specimens/No. of tests (cycle time)
Can auto transfer QC results to LIS/Onboard capability to review QC
Data-management capability/Instrument vendor supplies LIS interface
LIS interfaces up and running in active user sites
LIS interface operates simultaneously w/running assays
Bidirectional interface capability
Interface available (or will be) to auto specimen handling system
Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component
Can order (via modem) malfunctioning part(s) w/o operator
On-site response time of service engineer
Mean time between failures/To repair failures
Avg. time to complete maintenance by lab personnel
List price/Targeted bed size or daily volume
Annual service contract cost (24 hours/7 days)
Training provided w/purchase/Advanced operator training
Distinguishing features (supplied by vendor)
Auto detection of adequate reagent or specimen
Primary tube sampling/Tube sizes/Pierces caps on primary tubes
Sample bar-code reading capability/Autodiscrimination
Onboard maintenance records/Maintenance training demo module
Tests cleared but not released for clinical use
Name of device/First year sold/No. of analyzers sold in 2009
No. of devices sold in U.S./Outside U.S./List price
Dimensions (H x W x D)/Weight
Analytes measured on device
Parameters calculated on device
Barometric pressure
Analytical method(s), technology(ies) employed
Device is part of a series of related models
User list or group available
Device warranty
Loaner devices provided
Average expected life of device
Open or closed system/External gas tanks required
For POC testing or laboratory
POC:
Uses disposable prepackaged reagent/Electrode system for analysis
No. of disposable reagent system units in basic shipment package
No. of samples analyzed per one disposable reagent, electrode system
List price per disposable reagent system
Reagent unit storage requirements
Shelf life of disposable units
Laboratory:
No. of different disposable reagents required to maintain device
Max. No. of specific analyte reagents that can reside in device at once
Shelf life
Cost per test/Reagent cost per test
Calibrations required
Calibration frequency
Calibrants traceable to NIST standards
Internal QC program recommended
QC features
Remote control of device from laboratory
System can use LOINC to transmit results to LIS
How labs get LOINC codes for reagent kits
Detects clots within analysis chamber
Specimen types suitable for device
Acceptable anticoagulants
Sampling technique
Suitable for samples from well neonates/Sick neonates
Sample size for complete panel of analyte results
Sample size differs with No. of analytes selected
Recommended collection device
Provides for patient temperature corrected results
Time from sample introduction to result availability
Max. No. of patient samples per hr/Max. No. of measured parameters per hr
Optimal throughput when calibrated and awaiting specimens
Calibration can be interrupted to perform stat sample
Contraindications
Known interferences
Restrictions based on Hct
Sampler has self-wiping probe
Time required for maintenance by lab personnel
Onboard diagnostics for troubleshooting/Limited to software
Diagnostics performed through modem
Training & certification program for user
Method of analyst ID in system
Supports bar-code scanning of
User can search for and review previous patient results on screen
Built-in printer/Data port
Information on hard copy report
Analyzer connects to
Interface standards supported
To upload patient & QC results, how analyzer connects to external system
Information included in transmission from analyzer to external system
Hardware/Software for data management system
No. of different management reports system produces
Contents downloaded from DMS to analyzer
System connected (live installations) to which LISs, HISs
• using screen animation, screen scraping
• using standard HL7 interface
• using proprietary protocol interface
Use a third-party interfacing tool, engine for LIS, HIS interfaces
Distinguishing features (provided by vendor)
Response for hardware & software failure/User ID & QC failure/ Calibration & power failure
Name of system/First year installed/No. of 2012 contracts signed
No. of live sites installed in N. America/Europe/Asia-Australia
Automation products that are available
• Pre-analytical processor/Total laboratory automation
• Automated functions: Accessioning/Track load/Centrifugation/Decapping
• Automated functions: Rack specific sort/Aliquot/Tube relabeling/Resealing
• Automated functions: Storage-retrieval/Intelligent sample routing
• SW: Dedicated Process Control/Middleware control using LIS/Architecture
• Company has dedicated automation support team/Remote system monitoring
Software features/functionality
• Patient demographics and insurance data/Rules-based architecture
• Supports data retrieval/Internet connectivity
• Online real-time help system/QC/Stats and management reports
• Evaluates validity and releasability of results from automated analyzers
• Specimen tracking/Priority processing/Random-access spec. movement
• Supports accession number redundancy (duplicate specimen ID)
• Supports specimen carrier and level identification
• Unique bar-code number per container required
• Specimen routing/Multistop routing (one tube to multiple workstations)
• Specimen scheduling/Instrument scheduling
• Routes test to workstation/Automatic reflex, repeat, dilutions
• Supports multiple HW configuration/Supports other proprietary transport. HW
• Sample storage and retrieval SW/Supports approved CLSI standards
LIS(s) and versions interfaced and live w/LAS/How LIS(s) are interfaced with your LAS/LOINC can be used to identify tests when communicating with LIS
Transportation systems available
• Model/Dimensions* (H × W × D)*/Conforms to CLSI Stand. Auto 1-5
• Containers device accommodates/Average throughput in cm per second
• Supports automatic rerouting for reflex-repeat-dilutions
• Modular HW/Installed options/Device can operate in track and manual mode
• Required utilities/Required maintenance
• Carrier type/Scalable system
Automated centrifugation available
• Model/Dimensions (H × W × D)/Conforms to CLSI Stand. Auto 1-5
• Maximum throughput/Containers device accommodates
• Can identify tube types for custom programmed rate and spin times per run
• More than one centrifuge can be connected to track system
• For multi-unit centrifuge, each centrifuge operates independently for rate and time
• Maintenance required
Automated input/accessioning available
• Model/Dimensions (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput**
• Containers device accommodates/Dedicated lanes for stat samples
• Maximum No. of samples that can be loaded/Maintenance required
Automated decapping available
• Model/Dimen. (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput**
• Containers device accommodates/Maintenance required
• Removes multiple size tube caps per run/Removes screw type sample caps
Automated sorting available
• Model/Dimen. (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput**
• Containers device accommodates/Software can sort by
Specimen integrity monitor available
• Model/Dimen. (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput**
• Containers device accommodates/Maintenance required
Automated aliquotting available
• Model/Dimen. (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput**
• Containers device accommodates
• Inspects samples for bar code/Detects and reports clots in specimen
• Detects and reports quantity not sufficient specimens/Maintenance required
Instrument (analyzer) interfaces
• Rules-based instrument interface control subsystem
• Process control of instrument via control subsystem
Physical/hardware (instrument/specimen) interface
• Hematology/Chemistry/Coagulation
• Immunoassay/Urinalysis
Instruments to which your system or product is interfaced
Other robotic products/components to which system or product is linked
Automated recapper or sealer available
• Model/Dimen. (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput*
• Recaps-seals multiple size tubes simult./Containers device accommodates
• Maintenance required
Automated storage and retrieval available
• Model/Dimen. (H × W × D)/Conforms to CLSI Stand. Auto 1-5/Avg. throughput*
• Containers device accommodates/Connects to the track
• Room temperature/Minimum and maximum number of tubes stored per module
• Multiple size tubes can be stored in the same module/Maintenance required
• Refrigerated storage and retrieval capability
Longitudinal upgrade pathway or plan to protect users’ investments
Average time to install/Who provides service, support/Hours support is available
On-site biomedical engineer required/User group meets regularly
List price
Individual list prices for components
• Process control SW/Transportation systems/Auto. centrifugation
• Auto. input, accession/Auto. decap/Auto. sort/Auto. storage and retrieval
• Specimen integrity monitor/Automated aliquot
• Instrument (analyzer) interfaces/Automated recap
Distinguishing features (supplied by company)
Name of instrument
Country where designed/manufactured/reagents manufactured
Instrument FDA cleared or approved/Platform
First year sold in U.S./sold internationally/installed
Dimensions in inches (H × W × D)/Footprint in sq. ft./Noise generated in dB
Supplied with UPS/BTU/Space modification requirements
Instrument requires floor drain/separate room for contamination control
Physical contamination control features
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements
* For basic building block unit
** Average throughput in specimen containers per hour per device
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Name of instrument/First year sold in U.S./List price
No. of units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Reagents manufactured
Operational type/Reagent type
Sample handling system/Model type
Dimensions in inches (H × W × D)/Instrument footprint
Tests available on instrument in U.S.
Research-use-only assays/Tests in development
Analytes for which user-defined methods have been implemented
Methods supported/Immunoassay methods
No. of direct ion selective electrode channels
• Must load separate reagent pack for each specimen
• Separate reagent pack for each test run
No. of different measured assays onboard simultaneously
• No. of different assays programmed and calibrated at once
• No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates reagent containers onboard at once/Tests per container set
• Shortest/Median onboard reagent stability/Refrigerated onboard
• Multiple reagent configurations supported
Reagent container placed directly on system for use
Instrument has same capabilities when third-party reagent used
Walkaway capacity in minutes/Based on No. of specimens/Based on No. of tests-assays
System is liquid chemistry, dry chemistry, or reconstituted onboard
• Uses disposable cuvettes/Maximum No. stored
• Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
System supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption in L per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability/Autodiscrimination
• Reagent bar-code reading capability
Onboard test auto inventory (determines volume in container)
• Measures No. of tests remaining/Short sample detection/Clot detection
• Automatic detection of adequate reagent for aspiration and analysis
• Hemolysis/Turbidity detection-quantitation
Dilution of patient samples onboard
• Sample volume can be reduced to rerun out-of-linear-range high results/Increased to rerun out-of-linear-range low results
Autocalibration or autocalibration alert
Typical calibration frequency for ISE/Metabolites/Therapeutic drugs/Drugs of abuse
Automatic shutdown/Startup programmable
Stat time to completion of all analytes/throughput per hour for:
• Sodium, potassium, chloride, TCO2
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
• Albumin, direct and total bilirubin, AST, ALT, ALP
• Typical time delay from ordering stat test to aspiration of sample
Frequency of QC required/Onboard SW capability to review QC
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data management capability/Instrument vendor supplies LIS interface
• LISs with which system interfaces in active user sites
Bidirectional interface capability
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders and results
• How labs get LOINC codes for reagent kits
Lab can control analyzer remotely
Modem servicing available/System can diagnose own malfunctions
On-site time of service engineer/Onboard error codes for troubleshooting
• Mean time between failures/To repair failures
Onboard maintenance records/Maintenance training demo module
Training provided with purchase/Advanced operator training
Annual service contract cost (24 h/7 d)
Distinguishing features (supplied by company)
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
• Calibrants stored onboard/Multipoint calibration supported
Co. performs installation, operation, and performance qualifications/Electrical req.
Labor and parts warranties/Training with purchase/Advanced operator training
Delivery time/Delivery charges/Installer/Time to install on site
Training location/No. of techs that can receive initial training/Length of training
Additional on-site training/Retraining at company facility
Test menu
No. of tests for which analyzer has FDA-cleared applications/CE-mark
Tests available in U.S./outside the U.S.
Tests not available in U.S. but submitted to FDA/available in other countries only
Research-use-only assays/Tests in development
Open-channel capabilities/Start-up and preparation time
Model type of sample handling system/Maximum sample load capacity
Min. specimen volume/Sample volume flexibility/Other sample volumes avail.
Min. dead volume/Pediatric sample volume/Primary tube sampling
Sample tube sizes/Sample bar-code reading/Autodiscrimination in 1D or 2D
Sample bar-code languages/Sample types available in open mode
Clot detection/Open extraction platform/Sample types (open extraction)
Amplification reagents or methods supported
Extraction methods supported for: RNA extract./DNA extract./total nucleic acid
No. of different assays onboard at once/Programmed or calibrated at once
Tests per container set/Multiple reagent configurations supported
Reagent container placed directly on system/Onboard test auto inventory
Determines reagent container vol./Reagent bar-code reading/Reagents bar coded
Info. in bar code/Monitors expiration date/Auto lot recognition or calibration
Auto detection of adequate reagent or specimen/Reagents avail. liquid or dry
Reagent reconstitution required/Chemical contamination control
Onboard test auto inventory/Capacity for inventory monitoring by bar code
System is open to homebrew/General-purpose reagents allowed
Same capabilities when third-party reagent used/Lot sequestering available
Closed-vial stability for amplification reagents/extraction reagents
Storage temp. requirement for amplification reagents/extraction reagents
Shipment temp. requirement for amplification reagents/extraction reagents
Location from which reagents shipped/Min. and max. reagent shelf-life guarantee
Autocalibration or autocalibration alert/Multipoint calibration supported
Assay calibrations required by end-user/Calibrants can be stored onboard
Multiple calibrant lots stored for same assay/Required calibration frequency
Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC
Total number of controls per batch for 24 tests/42 tests/72 tests/96 tests
Walkaway capacity/Tech hands-on time (both for batch of 96 samples)
Uses disposable pipette tips/Maximum number of pipette tips stored
Time between start and initial result/Instrument automatic shutdown
Startup programmable/Remote system monitoring/Waste req. for disposables
Windows technology/Mouse or touchscreen/Modular add-on capability
Service contracts available/Mean time between failures/to repair failures
Turnaround time for problem solving: by phone/e-mail/field service
No. of U.S. field reps/Service engineer on-site response time/Hours & days avail.
Guaranteed response time/Modem servicing available
System can diagnose own malfunctions
Order parts via modem/Onboard error codes/Maintenance training demo module
Average maintenance time for lab personnel/Onboard maintenance records
Preventive maintenance per year for sample extraction/amplification detection
Downtime for preventive maintenance/Spare parts on site
Patient demographics and insurance data available via rules-based architecture
Sample ID tracked from sample input to result/Data retrieval or Internet connectivity
Online real-time help, QC, stats and management reports/Evaluates results validity
Priority processing/Random-access specimen movement
Supports accession No. redundancy/Specimen carrier and level identification
Unique bar code per container req./Multistop routing (1 tube to mult. workstations)
Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions
Sample storage and retrieval software supports CLSI standards
LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS
QC results auto transferred to LIS/Data management capability
Interfaces operational in active user sites
Rules-based control subsystem/Process control via control subsystem
Auto transfer QC results to LIS/Onboard capability to review QC
Uses LOINC to transmit orders and results/Unidirectional interface capability
Results immed. transmitted to LIS/Interface avail. to auto specimen-handling system
Stores QC lot files/Worklist edit capability/Security/Viewable PCR graphs
Software upgrades since system launch/Can print, archive, transmit data
Distinguishing features (supplied by company)
*for calibration and controls
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
LIS operates simultaneously with assays running
Name of instrument
First year installed in U.S./Outside U.S./No. of units sold in 2011
No. units installed in U.S./Outside U.S./List price
• Laboratory
• Flags
FDA-cleared tests not clinically released
Tests not available but submitted for 510(k) clearance
Tests in development
Tests unique to analyzer
Differential method(s) used
Linearity:
• WBC count/RBC count
• Hemoglobin/platelet
• MCV (fL) or Hct (%)
Precision:
• WBC count/RBC count
• Hemoglobin/platelet
• MCV or Hct
Accuracy of automated differential compared with manual differential (per CLSI H-20A2)
Interfering substances:
• WBC
• RBC
• MCV or Hct
• Platelet
• Hemoglobin
Interfering substances: Differential
Maximum CBCs per hour/Maximum CBCs and differentials per hour
Minimum specimen volume open/Closed/Sample dead volume closed
Microsample capability
Prepares microscope slides automatically or flags problems for slide prep
Number of automatic slidemakers available/List price
Archives patient data/Previous patient results included with recent results
Maximum archived data accessible when system online
No. specimens for which numeric results saved in memory at once
No. specimens for which histo/cytogram results saved in memory at once
Performs delta checks
Tags and holds results for followup, confirmatory testing, or rerun
Parameters for flags for holding samples defined by user or vendor
Scattergram display: cell-specific color
Histogram display: color with thresholds
User interface can display choice of specimen/result information
LIS interface formats supported
Information transferred on LIS interface
LOINC codes transmitted with all results
Interface available or planned to automated specimen-handling system
Bar-code symbologies read on specimen tube
Accommodates bar-code placement per CLSI standard Auto2A
Time required for maintenance by lab personnel
Onboard diagnostics for troubleshooting/Limited to software problems
Manufacturer can perform diagnostics via modem
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
Instrument name/First year sold
Number of units installed in U.S./Outside U.S.
Number of contracts signed between 1/1/12 and 11/30/12
Country where analyzer designed/Manufactured
Operational type
Reagent type
Operates on whole blood or spun plasma
Sample handling system
Model type
Dimensions (H × W × D)/Weight/Instrument footprint
FDA-cleared clotting-based tests
FDA-cleared chromogenic tests
FDA-cleared immunologic tests
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance
Tests in development but not yet submitted
Methodologies supported
Operator must load sep. reagent pack per specimen/Test run
Number of different measured assays onboard simultaneously
Number of different assays programmed and calib. at one time
Number of user-definable (open) channels
Of those defined, number active simultaneously
Factor assays require manual manipulation or dilutions
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard
Multiple reagent configurations supported
Reagents, consumables loaded without interrupting testing
Same capabilities when third-party reagent used
Maximum time same lot number of reagents can be used
Walkaway capacity: Number of specimens/Number of tests
Minimum sample volume aspirated precisely at one time
Standard specimen volume required to run PT or PTT/ Factor VIII activity
Disposables used/Price of each
Supports direct-from-track sampling
Primary tube sampling supported/Pierces caps on primary tubes
Sample bar-code reading capability
Reagent bar-code reading capability
Onboard test automatic inventory
Measures No. of tests remaining/Short sample detection
Clot detection as preanalytical variable in plasma sample
Auto. detects adequate reagents for aspiration and analysis
Hemolysis/Turbidity detection-quantitation
Dilution of patient samples onboard
Automatic rerun capability/Auto reflex testing capability
Lag time during which hypercoagulable sample not detected
Read time extended for prolonged clotting times
User can set different-than-standard:
• Reagent volumes/Sample volumes
• No. and sources of reagent
• Incubation times/Reading times
Autocalib. or autocalib. alert/Multipoint calib. supported
Auto shutdown/Auto startup programmable
Stat time to complete all analytes/Throughput per hour for:
• PT alone
• PT, PTT
• Fibrinogen
• Factor VIII activity assay
Time delay from ordering stat to aspiration of sample
Automatic transfer of QC results to LIS
Data-management capability
Interface supplied by instrument vendor
Interfaces in active user sites for:
Bidirectional interface capability
Results transferred to LIS as soon as test time complete
LOINC codes transmitted with all results
How labs get LOINC codes for reagent kits
Electronic interface available (or will be) to automated (or robotic) specimen handling system
Modem servicing
Time required for maintenance by lab personnel
Onboard maintenance records
Training provided with purchase
Approximate number of training hours needed per tech
List price
Annual service contract cost (24/7)/Warranty with purchase
Distinguishing features (supplied by company)
Name of anatomic pathology system
First ever AP system installation
Most recent AP system installation (based on Dec. 2012 survey deadline)
Last major product release for featured AP system
No. of contracts for sites operating AP system (hospitals/independent labs/clinics or group practices/other U.S. sites/foreign sites)
• No. of contracts that went live in calendar-year 2012
• No. of contracts signed in calendar-year 2012
No. of sites operating AP system (No. of these sites outside U.S.)
Percentage of installations that have stand-alone AP systems
No. of employees in firm/In AP systems development, install, support
No. of workstations in sites operating AP system
Range in No. of surgical pathology cases per year in installed sites
Range in No. of gynecologic cytology cases per year in installed sites
Programming language(s)
Databases and tools used
Word processor(s) used
Operating system(s)
• Surgical pathology information system
• Cytology information system
• Autopsy information system
• Autopsy measurements and organ weights
• Specimen log-in/Specimen tracking and retrieval
• Entry of block IDs
• Histology slide labels
• Linear bar codes/Two-dimensional bar codes
• Histology worksheets
• Word processing—vendor specific
• Voice entry of gross description/Voice entry of final diagnosis
• Gross and microscopic images integrated in reports
• Electronic signature
• Remote printing of completed reports
• Direct fax reports
• Web-based remote inquiry of reports
• Physician Web access for order entry
• Natural language search capability
• Multi-site or multi-facility–wide area network
• Sound-alike retrieval of patient history
• Tumor registry reports/Management reports
• Reports sufficient to comply with CLIA ’88 regulations
• Comprehensive billing and accounts receivable
• Interface to external billing system
• HIS interface: admissions/discharge/transfer
• HIS interface: result reporting/HIS interface: incoming clinical results
• Partin tables or Gleason score calculations
• Synoptic reporting
• Client services module
• Consult management and reporting
Percentage of sites using result-reporting interfaces to external systems based on transmission of fully formatted (e.g., PDF or CDA) results
Software provides indexed field in each test definition for LOINC code
AP system supports use of SNOMED CT
System sends cancer diagnoses or surveillance data to tumor registries or public health agencies via computer-to-computer interface
Other vendors to which system has a lab-related interface
Voice-recognition products or partners that system uses
Histology and cytology devices interfaced
Languages (other than English) offered on system
Client receives copy of source code
User group that meets on established schedule
Total cost for smallest stand-alone AP system installed*
Total cost for largest stand-alone AP system installed*
Base price of integrated system, excluding AP configuration
Total incremental cost for smallest AP configuration installed*
Total incremental cost for largest AP configuration installed*
*total cost includes hardware, software, installation, and training; Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Total units sold in U.S./Total units sold outside U.S.
No. of contracts for product signed in 2010
Dimensions (H × W × D)/Weight
Analytical method or technology or enzyme system used
No. of disposable reagent system units per basic package
Disposable units shelf life/Reagent unit storage requirements
Digital readout character size/Keypad input capability
User defines QC lockout intervals/QC lockout can be circumvented
Information for which device supports bar-code scanning
Method of analyst ID / ID required
Internal memory size/Maximum No. of patient results stored
Meter connections for information transfer
How meters are connectd to external system to upload results
Information contained in transmission to external system
Hardware/software for data management system
No. of different management reports system can produce
Contents downloaded from DMS to meter
LISs / HISs to which system is connected (live installs) using:
• screen animation/screen scraping
• standard HL7 interface
• proprietary protocol interface
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces
Distinguishing features (supplied by company)
Tabulation does not represent an endorsement by the College of American Pathologists.
Databases used or supported
Name of instrument/First year sold
Professional or home use
Total units sold in U.S./Total units sold outside U.S.
No. of contracts for product signed in 2012
Dimensions (H × W × D)/Weight
Analytical method or technology or enzyme system used
No. of disposable reagent system units per basic package
Disposable units shelf life/Reagent unit storage requirements
Digital readout character size/Keypad input capability
How results are displayed
Specimen types/Sampling techniques
Minimum specimen volume required
Suitable for samples from well neonates/Sick neonates
Time from sample introduction to result availability
Batteries used/No. used/Average life of one set of batteries
Average expected life of device/Mean time between failures
Device warranty/Service options/Loaners provided
User list or user group
Toll-free No. for customer questions/Hours of operation
Training & certification program/No. of training days provided
Average time for lab to complete maintenance
Internal QC recommended or required
Between instrument CV (based on PT) at the following glucose levels:
• <50 mg/dL
• 100–200 mg/dL
• >400 mg/dL
• Program name, year/Challenge No./Level of mean glucose challenge sample
Accuracy/Compared to what reference method or device
Precision/Compared to what reference method or device
Linear range
Suggested dynamic or measurement range
Contraindications
Known interferences/High-altitude interference
Restrictions based on hematocrit
Electronic and optical function checks
Sample quantity checks
When auto lock or shutdown occurs
User defines QC lockout intervals/QC lockout can be circumvented
Information for which device supports bar-code scanning
Internal memory size/Maximum No. of patient results stored
Meter connections for information transfer
How meters are connected to external system to upload results
Information contained in transmission to external system
Hardware/Software for data management system
No. of different management reports system can produce
Contents downloaded from DMS to meter
LISs/HISs to which system is connected (live installs) using:
• Screen animation/Screen scraping
• Standard HL7 interface
• Proprietary protocol interface
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces
Distinguishing features (supplied by company)
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
Method of analyst identification/Identification required
Name of billing/accounts receivable/revenue cycle management system
First ever billing/AR*/RCM** system install/Most recent billing/AR/RCM system install***
Last major product release for featured billing/AR/RCM system
No. of contracts for sites operating billing/AR/RCM system
• Contracts signed since March 2011/Gone live since March 2011
No. of sites operating billing/AR/RCM system (HL/IL/PP/PO/OL/FI)****
No. of inpatient invoices handled by installed sites annually
No. of outpatient requisitions handled by installed sites annually
Percentage of installations that have standalone billing/AR/RCM systems
No. of user workstations in sites operating billing/AR/RCM system (average)
No. of employees in entire company
• No. of employees dedicated to software development, installation, support
Server platform
PC or workstation platform
Innovative peripherals
Operating systems
Databases and tools used
Pathology-related information system and software interfaces
Features (listed as a percentage of live installations or based on availability)
• Patient demographics transferred via interface from LIS to billing/AR/RCM system
• 1500 claim form generation (paper version)
• UB-04 (formerly UB-92) claim form generation (paper version)
• Client invoices
• Patient invoices
• Reprints of above on demand
• Key indicator tracking (online view of site-assigned key indicators)
• Test profile versus component billing
• Medical-necessity screening for Medicare
• Professional component billing
• Auto delete of nonbillable procedures
• Technical component only
• Retain demographic data, repeating patients
• Account and patient payment posting
• Accounts receivable system
• Management or marketing reports
• Automatic balance billing to patients
• Capitation billing plus billable tests
• Utilization reports for managed care
• Global charges for lab tests
• Unlimited user-defined fee schedules
• Track financial classes
• Allow open-item accounting (each line item on bill can be handled separately)
• User report writer
• User-defined collection system
• User-configurable dunning
• Client services or call tracking module
• Rules-based processing/claims scrubbing/bundling/unbundling/72-hour rule
• Multi-lab or multi-company processing
• Support all HIPAA transaction sets
Billing/AR/RCM system supports electronic data interchange with third-party payers and claims clearinghouses
• Electronic functions offered
Third-party rules and coding updates supported by system
Complete ASP solution for billing/AR/RCM system
• Method of charging for ASP service
• Client software required
• ASP information conduit
• Client contracts supported from data center not operated by client
• How data center is operated
Indexed field in each test definition for LOINC code
Provide LOINC dictionary for each new installation
Journaling/Source code
Methods by which users can tailor billing/AR/RCM system in their own setting
Total cost for smallest standalone billing/AR/RCM system install*****
Total cost for largest standalone billing/AR/RCM system install*****
Total incremental cost for smallest configuration of billing/AR/RCM
Total incremental cost for largest configuration of billing/AR/RCM
Distinguishing features (supplied by company)
*AR=accounts receivable/**RCM=revenue cycle management
*** based on June 2012 survey deadline
**** HL=hospital labs, IL=independent labs, PP=pathology practices (only surgical pathology/cytology services), PO=physician offices, OL=other U.S. locations, FI=foreign installations
Note: A dash in lieu of an answer means company did not answer question or question is not applicable.
Instrument name
First year sold
No. of units sold in U.S./Outside U.S.
No. of units sold in 2010
• units sold to:
Country where analyzer designed/Manufactured
Is instrument POC or self-monitoring analyzer?
Specimen type
Model type
Dimensions in inches (H × W × D)/Weight
Specimen volume needs
Clotting-based tests for which device has FDA-cleared applications
Tests using other methodologies for which device has FDA-cleared applications
FDA-cleared tests but not yet clinically released
Tests submitted for 510(k) clearance
Tests in development but not yet submitted for clearance
Method of endpoint detection
Quality control methods
• Electronic
• Liquid
• Lyophilized
• Integrated QC with each analysis
• Automatic lockout for QC failure
• Other
Time (in minutes) to perform control plus specimen test
• PT:
• PT and PTT:
• ACT:
Data-management capability
Includes QC
System can automatically transfer data to information system
• Patient data
• QC data
Interface supplied by instrument vendor
LOINC codes transmitted with results
How labs get LOINC codes for reagent kit
Commercially available systems for which interfaces are up and running in active user sites
Lab can control analyzer remotely
Real-time wireless linkage to LIS or HIS
Positive identification system (e.g. bar code) for:
• Patient specimen
• Reagent
Onboard system for automatic error detection
Training provided with instrument purchase
Approx. No. of training hours needed for:
• Medical staff
• Patient
Patient self-testing program is available
Instrument list price
Reagent rental or lease only
Cost per sample for:
• PT: Cost per sample for reagent rental
Cost per sample if device purchased
• PTT: Cost per sample for reagent rental
Cost per sample if device purchased
• ACT: Cost per sample for reagent rental
Cost per sample if device purchased
CLIA ’88 complexity rating
Unique advantages (provided by the vendor)
Increased to rerun out-of-linear-range high/low results
Name of positive patient ID product
• Previous name(s) and/or marketer(s) of product in past five years
Components of positive patient ID product
Company is a reseller of this product(s)
• For whom company is a reseller
Company sells its products through distribution partners
• Vendors with which company partners
First ever installation of a positive patient ID product
Most recent installation of current version of positive patient ID product
Last major product release
No. of contracts for U.S. sites where product is installed and operational
No. of contracts for foreign sites where product is installed and operational
No. of facilities where product is installed and operational
Secure techniques to verify patient ID prior to each intervention or specimen collection
Product functionality
Techniques for specimen identification at time of specimen collection
Data elements encoded on specimen label in machine-readable format
Bedside technology for blood transfusion offered via positive patient ID product
• Techniques for reading labels on blood units
• Manual entry of patient ID permitted for matching blood units for transfusion
Medication tracking offered via positive patient ID product
• Techniques used to read labels on medications
• Products that ID-matching software runs on
FDA 510(k) approval
• Applied for, but not yet received, FDA 510(k) approval
• Intend to apply for FDA 510(k) approval
Hospital and/or laboratory information system interface(s)
Cost
• General license fee per facility
• Hardware cost for single handheld workstation
• Cost of software license per workstation
• Cost of information system interface
• Standard maintenance fee covers updates to positive patient ID product
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Name of device/First year sold/Number of analyzers sold in 2011
Number of devices sold in U.S./outside U.S./List price
Dimensions (H x W x D)/Weight
Analytes measured on device
Parameters calculated on device
Barometric pressure
Analytical method(s) or technologies employed
Device warranty/Loaner devices provided
Device is part of a series of related models
Average life expectancy of device
Open or closed system/External gas tanks required
Categorized for point-of-care testing or laboratory
Point of care:
Disposable prepackaged system used for analysis
No. of disposable reagent system units in standard package
No. of samples analyzed per one disposable reagent, electrode system
Reagent unit storage requirements
Shelf life of disposable units
Laboratory:
No. of different disposable reagents required to maintain device
Max. No. of analyte reagents that can reside in device at once
Shelf life of components
Cost per test/Reagent cost per test
Calibrations required
Calibration frequency
Internal QC program recommended
QC features/Capabilities of QC features
Remote control of device from laboratory
System can use LOINC to transmit results to LIS
System can use LOINC to transmit results to LIS
Specimen types suitable for device
Acceptable anticoagulants/Sampling technique
Sample size for complete panel of analyte results
Sample size differs with number of analytes selected
Time from sample introduction to result availability
Maximum No. of patient samples per hour/Maximum No. measured results per hour
Optimal throughput when analyzer calibrated, awaiting specimens
Calibration can be interrupted to perform stat sample
Known interferences
Sampler has self-wiping probe
Time required for maintenance by lab personnel
Service center performs diagnostics through modem
Method of analyst ID in system
Instrument response for:
• hardware failure/software failure
• QC failure
• calibration failure
For what bar-code scanning is provided
Built-in printer/Data port
Information listed on hard copy report
Analyzer connections
Interface standards supported
How analyzer connects to external system to upload patient and QC results
Information included in transmission from analyzer to external system
Hardware and software for data management system
No. of different management reports system produces
Contents downloaded from data management system to analyzer
System connected (live installations) to which LISs, HISs
Use a third-party interfacing tool, engine for LIS, HIS interfaces
Distinguishing features (provided by company)
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
Name of instrument
Country where designed/Manufactured/Reagents manufactured
Instrument FDA cleared or approved/Platform
First year sold in U.S./Sold internationally/Installed
Dimensions in inches (H × W × D)/Footprint in sq. ft./Noise generated in dB
Supplied with UPS/BTU
Physical contamination control features
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements
Co. performs installation, operation, and performance qualifications/Electrical req.
Labor and parts warranties/Advanced operator training
Delivery time/Delivery charges/Installer/Time to install on site
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility
Test menu
No. of tests for which analyzer has FDA-cleared applications/CE-mark
Tests available on instrument in U.S./Outside U.S.
Tests not available in U.S. but submitted to FDA/Available in other countries only
Research-use-only assays/Tests in development
Open-channel capabilities/Start-up and preparation time
Model type of sample-handling system/Maximum sample load capacity
Min. specimen volume/Sample volume flexibility/Other sample volumes avail.
Min. dead volume/Pediatric sample volume/Primary tube sampling
Sample tube sizes/Sample bar-code reading/Autodiscrimination in 1D or 2D
Sample bar-code languages/Sample types available in open mode
Clot detection/Open extraction platform/Sample types (open extraction)
Amplification reagents or methods supported
Extraction methods supported for: RNA extract./DNA extract./total nucleic acid
No. of different assays onboard at once/Programmed or calibrated at once
Tests per container set/Multiple reagent configurations supported
Reagent container placed directly on system/Onboard test auto inventory
Reagent container placed directly on system/Onboard test auto inventory
Determines reagent volume in container
Reagent bar-code reading/Reagents bar coded
Monitors expiration date/Auto lot recognition or calibration
Auto detection of adequate reagent or specimen/Reagents available
Reagent reconstitution required/Chemical contamination control
Onboard test auto inventory/Capable of inventory monitoring by bar code
System is open to homebrew/General-purpose reagents allowed
Same capabilities when third-party reagent used/Lot sequestering available
Closed-vial stability for amplification reagents/Extraction reagents
Storage temp. requirement for amplification reagents/Extraction reagents
Shipment temp. requirement for amplification reagents/Extraction reagents
Minimum/maximum reagent shelf-life guarantee
Autocalibration or autocalibration alert/Multipoint calibration supported
Assay calibrations required by end-user/Calibrants can be stored onboard
Multiple calibrant lots stored for same assay/Required calibration frequency
Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC
Total number of controls per batch for 24 tests/42 tests/72 tests/96 tests
Walkaway capacity/Tech hands-on time (both for batch of 96 samples)
Uses disposable pipette tips/Maximum number of pipette tips stored
Time between start and initial result/Instrument automatic shutdown
Startup programmable/Remote system monitoring/Waste req. for disposables
Windows technology/Mouse or touchscreen/Modular add-on capability
Service contracts available/Mean time between failures/To repair failures
Turnaround time for problem solving by phone/e-mail/field service
No. of U.S. field reps/Service engineer on-site response time/Hours & days avail.
Guaranteed response time/Modem servicing available
System can diagnose own malfunctions
Order parts via modem/Onboard error codes/Maintenance training demo module
Average maintenance time for lab personnel/Onboard maintenance records
Preventive maintenance per year for sample extraction/amplification detection
Downtime for preventive maintenance/Spare parts on site
Software and LIS interface:
• Patient demographics and insurance data available via rules-based architecture
• Data retrieval or Internet connectivity
• Online real-time help, QC, stats and management reports/Evaluates results validity
• Priority processing
• Supports accession No. redundancy/Specimen carrier and level identification
• Unique bar code per container/Multistop routing (1 tube to many workstations)
• Specimen scheduling/Routes test to workstation/Auto. reflex, repeat, dilutions
• Sample storage and retrieval software supports CLSI standards
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS
• QC results transferred automatically to LIS/Data management capability
Interfaces operational in active user sites
Rules-based control subsystem/Process control via control subsystem
LIS operates simultaneously with assays running
Uses LOINC to transmit orders and results/Unidirectional interface capability
Results immed. transmitted to LIS/Interface avail. to auto specimen-handling system
Stores QC lot files/Worklist edit capability/Viewable PCR graphs
Can print, archive, transmit data
*for calibration and controls
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
Distinguishing features (provided by company)
First ever/Most recent blood bank system installation*
Last major product release for version of product featured
Total number of contracts for sites operating blood bank system
•Contracts for U.S. hospitals with donor and transfusion services
•Contracts for U.S. hospitals with transfusion services only
•Contracts for U.S. regional blood centers with donor services only
•Contracts for U.S. regional blood centers with donor and transfusion services
•Contracts for foreign hospitals and regional blood centers
•Contracts for other sites
Total number of sites operating blood bank system
Installations not yet live (hospitals/regional blood centers/others)
Name of blood bank system
Percentage of installations that are standalone blood bank systems
No. of employees in entire company/Dedicated solely to blood bank systems development, installation, support
Number of different versions of this software installed
•Versions of product in field covered by FDA 510(k) clearance
•Versions of product that did not require FDA 510(k) clearance
Range in number of user workstations in live sites (average)
Software programming language(s)
Operating system(s)
Databases and tools
Features (listed as percentage of live installs or based on availability)
•Full support of ISBT 128 unit labeling
•Bar-code reading of donor and unit information
•Unit inventory
•Autologous and directed unit tracking
•Electronic crossmatch decisionmaking
•Antigen typing
•Integrated bedside check for transfusion using positive patient ID
•Track all steps in production of product
•Print donor unit labels—bar coded
•Interface with blood irradiator or centrifuges
•Centralized transfusion service capability
•Mobile scheduling
•Laptop-based mobile donor registration module
•Source or recovered plasma management
•Accounts receivable
Interfaces to automated donor infectious disease testing instruments
Interfaces to automated ABO/Rh/antibody screening instruments
Electronic interface to bedside patient ID system from other vendors
Languages (other than English) offered on system
Recommended tools to help clients validate their systems
System provides indexed field in each test definition for LOINC code
Provide LOINC dictionary for each new installation
Other vendors to which software has a lab system-related interface
User group
Source code
Cost for software modifications to comply with federal regs and laws
Total cost for smallest standalone blood bank system installation**
Total cost for largest standalone blood bank system installation**
Total incremental cost for smallest blood bank configuration installed**
Total incremental cost for largest blood bank configuration installed**
PC or workstation platforms
Automatic rerun capability
Name of instrument
Name of model/Model has been upgraded
Country where designed/Manufactured/FDA-cleared or approved
First year sold in U.S./Outside U.S./First year installed
Dimensions in inches (H × W × D)/Footprint of all instrumentation and computing hardware
Equipment supplied with system/Automation for library prep
Necessary equipment not included with system and additional cost
Bioinformatics tools provided/For use by biologist or bioinformatician
Supplied with UPS/Entire workflow can occur in same lab
Clean room requirements/Electrical connection
List price/Total list price for equipment needed to perform simplest and fastest workflow from amplif through variant calling (not typically found in lab)
Purchase options
Warranties offered
Training included/Total time for standard install and basic training
Training location/Follow-up training available
Instrument core performance:
Maximum No. of libraries amplified in single amplif event
Read length/Percent bases >Q30
Paired-end capability/tag lengths/spans
Fragment/tag lengths/spans
Mate-pair/tag lengths/spans
Single-end/tag lengths/spans
RNA sequencing/tag lengths/spans
ChIP sequencing/tag lengths/spans
Bisulfite sequencing/tag lengths/spans
Output per run
Total time from library construction to variant calling to achieve output per run/Technical bench time/Bioinformatics time
Sample preparation:
Total time for generating standard gDNA library
• Paired-end
• Fragment
• Mate-pair
• Single-end
• Single-end
• RNA sequencing
• ChIP sequencing
• Bisulfite sequencing
Hands-on time each:
• Paired-end
• Fragment
• Mate-pair
• Single-end
• RNA sequencing
• ChIP sequencing
• Bisulfite sequencing
Equipment required for library construction
Reagents and controls:
Cost per run
Cost per sample*
Reagent tracking method on instrument
Information contained in tracking method
Reagent shipping conditions/Storage conditions
Shelf life of amplification and sequencing reagents
Controls introduced during creation of library/Sequencing control avail.
Capable of complete walkaway automation for amp, seq, var calling
Remote system monitoring
Instrument control software and devices to start run/for data analysis
Total time required for setup of amplification, sequencing, and variant calling steps
Maximum No. of libraries sequenced in a single run
Types of maintenance plans available
No. of field apps scientists and engineers based in U.S.
Weekly maintenance required/monthly/pre-run
System offers secondary analysis software developed by instrument vendor
Variant report generated directly on instrument
Third-party analysis software available
Ability of software to detect mutations
Total No. of peer-reviewed publications for this platform
Published applications in pathology-related research
Fastest published turnaround time from sample to analyzed result
Lowest published variant sensitivity level
*inclusive of sample prep, for multiple configurations, using 1 Mb and 30x average coverage per sample
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Distinguishing features of sequencer (supplied by company)
Tests for research use only
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, %&# neut, mono, lymph, eos, baso):
Distinguishing features (supplied by company)
PT multicalibrators
test
No. of contracts signed since May 1, 2011
• Type of biometric application
Manual entry of ID No. from wristband if bar-coded wristband not available
• Manually entered ID Nos. distinguishable in database
• Facility can elect not to allow manual entry of ID No.
Handheld/point-of-care workstations
• Typical handheld workstation used
• Approximate weight of handheld workstation
• How handheld workstation communicates with bedside bar-code printers
• How handheld workstation communicates with host LIS
• Other vendors’ positive patient ID products can run on same handheld/ bedside PCs as company’s products without modifying operating system
Capability for interfacing company’s own LIS with positive patient ID products
Techniques to verify patient ID when creating a wristband on admission or to register outpatient not getting a wristband
Distinguishing features (supplied by company)
Other vendors to which software has a lab system-related interface
• Track profitability by test, payer, and client
• Support electronic formats, including ASC X12 5010, IAIBC EDI guidelines
• Support standardized coding systems, including ICD-9-CM, ICD-10, CPT, etc.
Source code
Total incremental cost for smallest configuration of billing/AR/RCM*****
Total incremental cost for largest configuration of billing/AR/RCM*****
***** total cost includes hardware, software, installation, and training
Distinguishing features (supplied by company)
• No. of employees dedicated to billing/AR/RCM system development, install, support
Number of contracts signed between June 2011–June 2012
Number of sites that went live between June 2011–June 2012
Server platforms
•Biometric ID of donors and/or patients
•Direct entry of test results
•Crossmatch results
•Donor recruitment and management
•Donor questionnaire
•Management reports
•Ad hoc report writer
•Quality control management
•Collection management
System available via ASP or cloud-based data center
Methods by which users can tailor blood bank system in their own setting
*based on July 2012 survey deadline **total cost includes hardware, software, installation, and training Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Distinguishing features (supplied by company)
Name of laboratory information system
First ever/Most recent LIS installation (based on September 2012 survey deadline)
Last major product release or update for featured LIS
Total No. of contracts for sites operating LIS
• Hospital/Independent lab contracts in U.S.
• Clinic or group practice contracts in U.S./Public health lab contracts in U.S.
• Contracts for other U.S. sites/Contracts for foreign sites
• No. of these contracts that went live between August 2011–August 2012
Contracts signed but LIS not yet operational (hospitals/independent labs/other sites)
• Total No. of contracts (live and not live) signed between Aug. 2011–Aug. 2012
Total No. of sites operating LIS (No. of these sites outside the U.S.)
Percentage of high-volume* sites installed/Low-volume** sites installed
Provide list of installed client sites to potential customers
No. of employees in entire company
• No. of employees dedicated to LIS development, installation, and support
No. of billed tests generated annually by labs using this LIS
Range in No. of user workstations in sites operating LIS
Central hardware or service type
How central server failure is handled
Programming language(s)
Operating system(s)
Databases and tools
System includes full transaction logging
Languages (other than English) offered on system
Features/modules (listed as percent of live installs or based on availability)
• Chemistry and hematology/Bar-coded collection labels
• Microbiology/Public health microbiology
• Blood bank donor and transfusion
• Surgical pathology/Cytology
• Molecular pathology
• HIS or EMR interface for admissions/discharge/transfer (ADT)
• HIS or EMR interface for order entry/Results reporting
• HIS or EMR interface for packaging results into PDF format
• HIS or EMR interface for packaging results into CDA1 format/CDA2 format
• Ad hoc reporting/Rules-based system
• Management and/or statistical reporting
• Outreach and/or commercial laboratory
• Compliance checking/Billing and accounts receivable
• Materials management and inventory
• Test partition/Remote faxing and printing
• HIPAA-standard transaction formats
• Web-based remote inquiry of reports/Web access for order entry
• Specimen management and tracking
• Compliance and quality assurance tools/Environmental health
System available via ASP or cloud-based data center
LIS can report lab data that is focus of meaningful use guidelines to public health agencies via automated electronic transmission using formats*** for:
• Microbiology data (culture and sensitivity)
• Other reportable diseases (blood, lead, immunology, etc.)
• Tumor diagnosis or registry data (using NAACCR Pathology Laboratory Electronic Reporting, vol. V, version 4.0, April 2011 edition)
Other lab vendors’ systems to which software has an interface
Total laboratory automation systems to which LIS can interface
LIS allows for image capture, display, reporting
Software provides indexed field in each test definition for LOINC code
Provide LOINC dictionary for each new installation
LIS supports use of SNOMED CT
Market modules for other hospital departments (percent of installs lab only)
No. of different types of lab instruments interfaced and operational with LIS
Percentage of LIS clients that use positive patient ID systems to identify patients and blood specimens at bedside
Source code/User group that meets regularly
Methods by which users can tailor LIS in their own setting
Total cost for smallest LIS installation****
Total cost for largest LIS installation****
Distinguishing features (supplied by company)
*generate >500,000 billed tests annually, or >200 bed hospitals, or >500 requisitions per day **generate <500,000 billed tests annually, or <200 bed hospitals, or <500 requisitions per day
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
***HL7 2.5.1, LOINC, SNOMED, etc. ****total cost includes hardware, software, installation, and training
• Cytogenetics/Flow cytometry
LIS allows third-party updates of tables and rules
Provide list of client sites to potential customers on request
Features (listed as a percentage of live installs or based on availability)
• Specimen labels
• Bar-coded slide labels/Bar-coded cassettes
AP system available via ASP or cloud-based data center
Methods by which users can tailor AP system in their own setting
Distinguishing features (supplied by company)
Name of middleware system
Products that middleware connects to LIS
First ever middleware installation/Most recent installation*
Last update of middleware system
No. of contracts for sites operating middleware
• U.S. contracts/Foreign contracts (countries)
• No. of these contracts signed in calendar-year 2012
No. of sites operating middleware/Percent of business that is middleware
No. of employees in firm/In middleware development, install, support
Provide list of client sites to potential customers on request
Hardware platforms
• Proprietary hardware required
Software platforms
Fault-tolerant solutions/Hardware must be purchased from company
Middleware software or drivers can operate in virtual hardware environment
Databases used or supported
Middleware can interface with instruments from any manufacturer
Types of data middleware can receive, store, transmit
No. of instruments one middleware device can support
Protocols middleware supports to interface to instruments
Low-level transport middleware supports to interface to instruments
Middleware can send results to and receive orders from reference labs
LIS/HIS/EMR interfaces for receiving orders
LIS/HIS/EMR interfaces for sending results
No. of diff. host system connections that can operate at once on middleware
Protocols middleware supports to interface to other systems
Middleware can be configured to automatically forward reportable diseases and other data to public health surveillance systems
Human languages (other than English) middleware supports
• Multiple languages can be used at same time on one system
Middleware supports local date and time formats
No. of users that can access middleware at once
No. of user security levels middleware supports
Middleware supports compound nested rules with multiple event actions
• Multiple event actions fired from one “if” condition statement
Programming or script language required to write rules
Full and persistent audit trail of rule execution/System supports rules testing
Rule sets applied to individual instruments or connections
Data from external databases retrieved and incorporated in rules processing
Rules test cases created, saved, used on demand for rules validation testing
System supports event notification
System user notified of rules-based events/Notification methods supported
Automation routes determined by user-defined rules
Middleware supports test-based load balancing across instruments
Events that lead to automation routes being dynamically updated
Audit trail of route a sample has taken
Laboratory automation system interfaces
Middleware interfaces with noninstrument automation devices
Back-end specimen storage and retrieval tracking
System allows management of inst. & automation device maintenance records
• System provides alerts when an instrument needs maintenance
System provides LIS downtime functions/System allows manual order entry
System generates downtime specimen ID/Algorithm for ID user definable
Quality control module/Interfaces to third-party quality control packages
System supports multi-rule quality control
System supports moving averages or average of normals
Users can customize screens/Users can define custom fields
Users can populate custom fields via user-defined rules
Screen has image support for any type of image
Users can design own reports/Report-generation software used
LOINC can be used to ID tests when communicating with LIS
Methods by which users can tailor middleware in their own setting
Types of system training available/On-site consulting
Smallest cost for hardware/software/annual maintenance
Largest cost for hardware/software/annual maintenance
Fee for additional users
Cost for cloud-based or similar products/services
*based on January 2013 survey deadline Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
No. of results/orders that can be stored in database
Distinguishing features of middleware (supplied by company)
LOINC can be used to identify tests when communicating with LIS
Name of laboratory-provider links (LPL) software
First-ever LPL software installation/Most recent installation*
Last update of LPL software
No. of host or central labs using software clinically
• No. of host labs that electronically transfer orders from physician’s or other client’s systems into LIS in host lab
No. of satellite or client locations installed/Non-U.S. host installations
No. of contracts for host labs signed in calendar-year 2012
Percentage of installations that have standalone LPL systems
No. of employees in firm/In LPL systems development, installation, support
Provide list of client sites to potential customers on request
Average time to install, build files, train office staff in a typical physician’s office
Languages (other than English) supported by system
Lab information system interfaces (other than company’s own products)
• Software modifications or modules required on host LIS to interface
EMR systems/POPMS** interfaced to transfer patient demographics or billing information to LPL system
EMR systems/POPMS interfaced to send lab orders to LPL system
EMR systems/POPMS interfaced to load lab results from LPL system back into EMR
How demographics or billing info. are sent from EMR syst. or POPMS to LPL syst.
External software tools to transfer data from EMR system or POPMS to LPL system
How results are returned to physician’s office
Data interface standards operational
System supports LOINC for identifying lab result database elements
Patient order and result database maintained on local PC
• Software displays results and allows orders to be entered in an offline mode
LPL system available via ASP or cloud-based data center
Features (listed as a percentage of live installs or based on availability)
• Order entry
- Medicare compliance checking using carrier-specific rules
- Advanced beneficiary notice printed if medical necessity criteria not met
- Local medical review policies can be viewed
- Automatic routing of order to different labs or hospitals according to payer rules
- Printing of lab’s requisitions/Printing of requisitions for other lab providers
- Duplicate order checking/Physician office-specific panels
• Automatic handling of scheduled or standing orders
• Bar-code collection label printing
• Two-dimensional bar code on printed requisition
• Software adapted for use in phlebotomy or collection stations
• Result receipt
- Stored as a block of text
- All items (result, reference range, units, etc.) stored as individual data elements
- Automatic parsing of report pages to extract results
- Inquiry mode that allows physician office to check specimen status with host
• Reporting
- In exact format received from host lab/Cumulative
- Integration of host and physician’s office lab results
- Display of new results for patient and/or clinic
- Remote access available to on-call physicians
- Unattended printing of reports
- Display current report with historical data on same screen
- Graph historical results with current results for trend analysis
• Physician can electronically sign reports to confirm review
• Physician can compose and send secure electronic messages to patients
• User-defined rule-based system and alerts in physician’s office module
• Electronic transfer of data to another physician’s office
- E-mail/Encrypted e-mail
- Web reference or pointer to Web site/Fax
• Physician’s office orders supplies from host lab
• Specimen pickup or courier requests to host lab
• Financial
- Billing, collections, accounts receivable
- Electronic claims transfer/Interfaces to billing systems
• Electronic medical record interface
• Interfaces to physician’s office lab instruments
• Entry of physician’s office lab results with edit checks
System cost: one-time or initial charges/Monthly subscription fees
• Basis for increasing fees as physician offices or referring sites are added
• Situations where fees increase with additional services
System priced on a cost-per-transaction basis
Distinguishing product features (supplied by company)
*based on February 2013 survey deadline **POPMS=physician office practice management system Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
Name of billing/accounts receivable/revenue cycle management system
First-ever billing/AR*/RCM** system install/Most recent billing/AR/RCM system install***
Last major product release of featured billing/AR/RCM system
No. of sites operating billing/AR/RCM system (HL/IL/PP/PO/OL/FI)****
No. of inpatient invoices handled by installed sites annually
No. of outpatient requisitions handled by installed sites annually
Percentage of installations that have standalone billing/AR/RCM systems
No. of user workstations in sites operating billing/AR/RCM system (average)
• No. of contracts signed since March 2012/No. of contracts gone live since March 2012
No. of contracts for sites operating billing/AR/RCM system
No. of employees in entire company
• No. of employees dedicated to billing/AR/RCM system development, install, support
Provide list of client sites to potential customers on request
Server platform
PC or workstation platform
Innovative peripherals
Operating systems
Databases and tools used
Other vendors to which software has a lab system-related interface
Features (listed as a percentage of live installations or based on availability)
• Patient demographics transferred via interface from LIS to billing/AR/RCM system
• 1500 claim form generation (paper version)
• UB-04 (formerly UB-92) claim form generation (paper version)
• Client invoices
• Patient or family invoices
• Reprints of above on demand
• Key indicator tracking (online view of site-assigned key indicators)
• Test profile versus component billing
• Medical-necessity screening for Medicare
• Professional component billing
• Auto delete of nonbillable procedures
• Technical component only
• Retain demographic data, repeating patients
• Account and patient payment posting
• Accounts receivable system
• Management or marketing report generation
• Automatic balance billing to patients
• Capitation billing plus billable tests
• Utilization reports generated for managed care
• Global charges for lab tests
• Unlimited user-defined fee schedules
• Track financial classes
• Allow open-item accounting (each line item on bill can be handled separately)
• User report writer
• User-defined collection system
• Track profitability by test, payer, and client
• Client services or call tracking module
• Rules-based processing/claims scrubbing/bundling/unbundling/72-hour rule
• Multi-lab or multi-company processing
• Support all HIPAA transaction sets, X12 5010A1, or IAIBC EDI guidelines
• Support standardized coding systems—i.e., ICD-9-CM, ICD-10, CPT
Billing/AR/RCM system supports electronic data interchange with third-party payers and claims clearinghouses
• Electronic functions offered
Third-party rules and coding updates supported by system
Software provides indexed field in each test definition for LOINC code
Provide LOINC dictionary for each new installation
Client can obtain source code
Methods by which users can tailor billing/AR/RCM system in their own setting
Total cost for smallest standalone billing/AR/RCM system install*****
Total cost for largest standalone billing/AR/RCM system install*****
Total incremental cost for smallest configuration of billing/AR/RCM*****
Total incremental cost for largest configuration of billing/AR/RCM*****
Billing/AR/RCM system available via ASP or cloud-based data center
Cost for cloud-based or similar billing/AR/RCM systems or services
Distinguishing features (supplied by company)
*AR=accounts receivable
**RCM=revenue cycle management
*** based on March 2013 survey deadline
**** HL=hospital labs, IL=independent labs, PP=pathology practices (only surgical pathology/ cytology services), PO=physician offices, OL=other U.S. locations, FI=foreign installations
***** total cost includes hardware, software, installation, and training
Note: A dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists

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