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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK080037 Summary

510(k) Summary

Date: July 1, 2008

A1. Contact Information; 
Official Correspondent:Jane Currier
1 MEDITECH Circle
Westwood, MA 02090
Telephone:781-821-2199
Fax:781-821-2199

 

A2. Device Name: 
Common Name:Client Server Blood Bank
Trade Name :MEDITECH Client Server Blood Bank with Electronic
Crossmatch Version 5.6
Classification Name:Standalone Blood Bank Software, Product Code 81 MMH

 

A3. Predicate Device :

The following Blood Bank management software products in the market will be referenced to compare Client Server Blood Bank with Electronic Crossmatch version 5.6 to show it is substantially equivalent in its intended use and features:

  • MEDITECH MAGIC Blood Bank Version 4.9, cleared for commercial distribution under BK060029
  • MEDITECH Client Server Blood Bank Version 5.1, cleared under BK980046

 

A4. Intended Use

The MEDITECH Blood Bank Software provides a variety of functionality for Healthcare Personnel. The software helps personnel, in both multiple and single facility organizations, manage their departments more efficiently by integrating donor, unit, and patient information.

The MEDITECH Blood Bank Software assists with:

  • Donor recruitment and scheduling
  • Tracking of donor products from receipt to final disposition
  • Patient processing
  • Specimen crossmatching
  • Specimen electronic crossmatching
  • Determine the suitability of released products upon issuing
  • Recording of transfusion information
  • Inventory management
  • Track product disposition
  • Reporting and tracking blood bank services across multiple facilities

The software also allows on-line inquiries and permanent storage of:

  • Donor history
  • Crossmatch results
  • Antigens/Antibodies
  • Transfusion data
  • Unit history
  • Patient's comprehensive blood bank history

 

A5. Device Description:

MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.

 

Highlights:

  • Donor recruitment and scheduling
  • Patient processing
  • On-line quality control
  • Transfusion management
  • Inventory management and utilization
  • Ability to report and track blood bank services across multiple facilities
  • Ability to calculate interpreted results of cell panels and antibody identification
  • Extensive reporting capabilities.


Standard Features

 

Historical Record of Information
MEDITECH’s Blood Bank application is designed to be a historical module that allows organizations to maintain a permanent on-line record of:

  • Donors and patients
  • Transfused units
  • Antigens/antibodies
  • Transfusions.

 

Donor Recruitment and Management
Donor recruitment and management features include:

  • Ability to maintain blood types, antigen/antibody profiles
  • On-line tracking of donor schedules and information
  • Ability to evaluate criteria, check eligibility, and schedule appointments
  • On-line donor recruitment phone lists and letters
  • On-line, user-defined donor questionnaires to stream line the qualification process
  • User-defined error checking logic allows staff to compare current information against data collected during the donor’s last appointment
  • System automatically generate deferrals when donors do not meet eligibility requirements
  • Ability to generate donor statistical reports.

 

Inventory Tracking and Utilization
MEDITECH’s Blood Bank application allows for comprehensive inventory management by tracking physical inventory as well as inventory utilization, based on pre-transfusion data. All transfusable products are tracked from the time they are entered into inventory through final disposition. Features include:

  • Ability to scan units into the inventory, either by individual unit or in batches
  • Automatic requisitioning for blood bank and serology tests via MEDITECH’s integrated system
  • Look back functionality assuring patient safety
  • Comprehensive inventory management reporting tools.

 

Multiple Specimen Processing
Electronic worksheets and process screens can replace the worksheets used to manually enter test results for specimens and units, creating streamlined and efficient processes, ensuring accurate information and improving patient safety. Features include:

  • Preview feature showing specimens and tests in batch format
  • Automatic release of crossmatches using rules-based logic
  • Process screens to quickly result and efficiently track unit status
  • Ability to efficiently process multiple units or specimens at one time.

 

Patient Reports
Standard and user-defined formats are available for activity or summary reports. Features include:

  • Summary and activity reports by physician, patient, or location
  • Discharge and extended summaries
  • Results available electronically via the Electronic Medical Record and over the Internet.

 

Reporting Capabilities
MEDITECH’s extensive reporting capabilities ensure that procedures are followed and cost effectiveness is maintained. Examples of reports include:

  • Outstanding Specimen Report
  • Transfusion Report
  • Inventory Reports
  • Unit Disposition
  • Overdue Warning Report
  • Unverified Results Report
  • Crossmatch/Transfusion Ratio Statistics by location or provider
  • Utilization Reports to assist in reviewing and ensuring appropriate use of products

Security

The MEDITECH Information Systems module (MIS) controls access to the MEDITECH Client Server Blood Bank System and ensures that data entry and data access is only available to authorized users. Only authorized hospital IT staff are provided access to the MIS module. User access to the MEDITECH Client Server Blood Bank System is controlled by user login which consists of a User ID and a secure user password. Each user can be defined to have specific access restrictions. Access to different functions within the MEDITECH Client Server Blood Bank System is controlled by the LIS Access Dictionary. Access to the LIS Access Dictionary module is available only to authorized personnel.

Audit Capabilities
The MEDITECH Client Server Blood Bank System includes audit tracking via several different reports that are built into the Blood Bank application.

 

A6. Technological Characteristics

The technological characteristics of the Blood Bank software system include the hardware, tools, and design control methodology used to develop, test, install, operate, and maintain the software. The design control process includes evaluation of the software requirements and analysis of potential hazards. As shown in section A7 below, the technological characteristics of Client Server 5.6 Blood Bank are substantially equivalent to Client Server 5.1 Blood Bank.

Database, Hardware, and Operating Systems

Server and storage hardware for the HP Intel Proliat, Dell Poweredge and IBM xSeries machines utilize the Windows 2000 Server operating system.

MEDITECH Clientsand Networking

Servers are networked with 10BaseT or 100BaseTX Ethernet client stations can be Windows desktop or laptop computers running the Meditech Remote Workstation software.

For LAN attachment, Client Server clients run in a 2-tier mode and communicate directly with file servers. A 3-tier mode is used for WAN attachment where bandwidth between clients and file servers is limited or latencies are high. Clients communicate with application servers, which in turn communicate with file servers. Application servers use the same hardware as file servers, except no external storages is needed.

MEDITECH Access to customer systems

Remote support of Client Server systems by MEDITECH staff requires MEDITECH approved ISDN access or Frame Relay access.

 

A7. Comparison to Predicate Device

Client Server Blood Bank Version 5.6 was developed based on the predicate device, Client Server Blood Bank Version 5.1, using the same tools, architecture, and methods. Software enhancements were added to the device to provide for customer needs. To show substantial equivalence with our own predicate device, comparisons have been drawn to the intended use and functional features of MAGIC Blood Bank Version 4.9 and Client Server Blood Bank Version 5.1.

 

MEDITECH Client Server 5.6
Intended Use
MEDITECH MAGIC 4.9
Intended Use
The MEDITECH Blood Bank Software provides a variety of functionality for healthcare personnel. The software helps personnel, in both multiple and single facility organizations, manage their departments more efficiently by integrating donor, unit, and patient information.The MEDITECH Blood Bank Software provides a variety of functionality for healthcare personnel. The software helps personnel, in both multiple and single facility organizations, manage their departments more efficiently by integrating donor, unit, and patient information.
Donor recruitment and schedulingDonor management
Patient processingPatient processing
Specimen crossmatchingTyping and crossmatching
Electronic CrossmatchingElectronic Crossmatching
Assists with determining suitability of released products upon issuingUnit issuing Assists with determining suitability of released products upon issuing
Recording of transfusion informationTransfusion data
Patient's comprehensive blood bank history.Patient's comprehensive blood bank history.
Reporting and tracking blood bank services across multiple facilitiesReporting and tracking blood bank services across multiple facilities
Inventory management Tracking of donor products from receipt to final dispositionUnit Inventory
Tracking of donor products from receipt to final disposition
The software also allows on-line inquiries and permanent storage of:
  • Donor history · Crossmatch results
  • Antigens/Antibodies
  • Transfusion data
  • Unit history
  • Patient's comprehensive blood bank history
The software also allows on-line inquiries and permanent storage of:
  • Donor history
  • Crossmatch results
  • Antigens/Antibodies
  • Transfusion data
  • Unit history
  • Patient's comprehensive blood bank history

 

FeatureMEDITECH Client Server 5.6 FunctionalityMEDITECH MAGIC 4.9 Functionality
Donor Management
  • On-line database of donors detailing blood type, antigen profile, most recent donation date, and comments
  • On-line donor recruitment phone lists and letters
  • Donor appointment scheduling
  • On-line donor medical history questionnaires
  • Donor inquiries
  • On-line database of donors detailing blood type, antigen profile, most recent donation date, and comments
  • On-line donor recruitment phone lists and letters
  • Donor appointment scheduling
  • On-line donor medical history questionnaires
  • Donor inquiries
Unit Inventory

Units and lot-specific products received from outside sources and donors are tracked from the time they are entered in the inventory through disposition. The application allows:

  • Unit receiving
  • Unit inquiries, transfers, pooling, edits, and quarantines
  • Compatible blood type searches
  • Bar coding capabilities
  • Inventory control
  • Automatic cancellation of product orders and reserve units for discharged patients. Inventory reports list expiring or contaminated units as well as those currently in stock.

Units and lot-specific products received from outside sources and donors are tracked from the time they are entered in the inventory through disposition. The application allows:

  • Unit receiving
  • Unit inquiries, transfers, pooling, edits, and quarantines
  • Compatible blood type searches
  • Bar coding capabilities
  • Inventory control
  • Automatic cancellation of product orders and reserve units for discharged patients. Inventory reports list expiring or contaminated units as well as those currently in stock
Unit Processing
  • Test result entry
  • Component and aliquot preparation with original unit data retention
  • Test result entry
Patient Processing

Staff members order tests and assign collection categories with the application's requisition entry routines.
Features include:

  • Demographic data entry for new patients
  • Label printing capability at order entry
  • Ordering of products and tests
  • View of related lab tests at time of product order
  • Duplicate order checking for tests and products
  • Instrument resulting of ABO/Rh

 

Collection lists and labels expedite specimen collection. Features include:
 

  • User-definable specimen labels and collection lists
  • Ability to generate bar code labels for specimens
  • Multisite tracking of products
  • Most recent specimens display first in History Inquiry.

 

Electronic worksheets can replace the manual worksheets now used to enter test results for specimens and units.

Reports provide nurses and physicians with patients' test results and cumulative summaries.

Staff members order tests and assign collection categories with the application's requisition entry routines.
Features include: 

  • Demographic data entry for new patients
  • Label printing capability at order entry
  • Ordering of products and tests
  • View of related lab tests at time of product order
  • Duplicate order checking for tests and products

 

Collection lists and labels expedite specimen collection. Features include:
 

  • User-definable specimen labels and collection lists
  • Ability to generate bar code labels for specimens
  • Multisite tracking of products

 

Electronic worksheets can replace the manual worksheets now used to enter test results for specimens and units.

Reports provide nurses and physicians with patients' test results and cumulative summaries.

Blood Bank HistoryPatients' blood bank information is linked to their Medical Record Numbers. Patient records can include:
  • Demographic information
  • Antigens/Antibodies
  • Transfusion administration/reaction histories.
Patients' blood bank information is linked to their Medical Record Numbers. Patient records can include:
  • Demographic information
  • Antigens/Antibodies
  • Transfusion administration/reaction histories.
Blood Bank Analyzer Interface for ABO/Rh resulting
  • Ortho Provue
  • Immucor Galileo
Electronic CrossmatchA user can initiate an electronic crossmatch.
  • If the patient or the unit do not meet pre-defined criteria, the user is prompted to result a serological crossmatch.

 

Electronic Crossmatch criteria can be used to ensure:

  • a current patient specimen and blood type are available
  • two determinations of the patient's blood type are specified
  • patient and donor are ABO compatible
  • a check for positive antibody screens exists
  • no clinically significant antibodies are present
  • donor ABO group and Rh Type on the unit label is confirmed
  • Antigen/Antibody validation

 

The system can also enforce a requirement for a second user to verify results on the current specimen.

A user can initiate an electronic crossmatch.
  • If the patient or the unit do not meet pre-defined criteria, the user is prompted to result a serological crossmatch.

 

Electronic Crossmatch criteria can be used to ensure:

  • a current patient specimen and blood type are available
  • two determinations of the patient's blood type are specified
  • patient and donor are ABO compatible
  • a check for positive antibody screens exists
  • no clinically significant antibodies are present
  • donor ABO group and Rh Type on the unit label is confirmed
  • Antigen/Antibody validation

 

The system can also enforce a requirement for a second user to verify results on the current specimen.

 

The required operating system, database, and required hardware characteristics of the Client Server Blood Bank 5.6 are substantially equivalent to the Client Server Blood Bank version 5.1.

FeatureMEDITECH Client Server 5.6
OS/Database/Hardware
MEDITECH Client Server 5.1
OS/Database/Hardware
Hardware: Servers
  • HP Alpha (Alpha Processor, 600Mhz, 256 MB)
  • HP Intel Proliant (Intel Dual-Core Processor, 2 Ghz, 2 GB)
  • Dell PowerEdge (Intel Dual-Core Processor, 2 Ghz, 2 GB)
  • IBM xSeries (Intel Dual-Core Processor, 2 Ghz, 2 GB)
 
  • Compaq Proliant (Intel)
  • Dell PowerEdge
  • IBM Netfinity
 
Client Hardware: Desktop Personal Computers*HP Deskpro 2000
HP Prolinea 575e
  • Pentium 4 processor
  • Running Windows 2000 and
  • Microsoft Internet Explorer
Intel-based personal computer
  • Running Windows 98 and
  • Microsoft Internet Explorer
Server Hardware: Laptop Computers*IBM Thinkpad 755, 755c
Toshiba satellite
  • Pentium 4 processor
  • Connected to a wired port
  • Running Windows 2000 and
  • Microsoft Internet Explorer
None listed
Hardware peripherals: Barcode Printers
  • AMT Datasouth Fastmark 4602
  • Citizen-America CLP-521
  • Citizen-America CLP-7202e
  • Datamax Prodigy Plus
  • Datamax Allegro2
  • Datamax E-4203
  • Datamax E-4204
  • Datamax I-4208
  • Datamax M-4208
  • Zebra Z4M
  • JJWild JJW1064, JJW1065, JJW1066
  • Datamax Allegro
  • Datamax Fargo • Datamax Prodigy
  • Datamax Prodigy Plus
  • Medplus Intellcode 4000
  • Datamax Prodigy Plus
  • JJWild 1062
  • Eltron LP 2242
Hardware peripherals:
Barcode Scanners
  • Datalogic Gryphon D100
  • Datalogic Gryphon D200
  • Datalogic Gryphon M100
  • Datalogic Gryphon M120
  • Datalogic DLL5010-mn
  • Datalogic DLL5510-mn
  • Datalogic DLC6065-mn
  • Datalogic DLC6090-mn
  • Opticon USB LGP1125
  • Opticon USB LGP5125
  • Symbol LS4008I
  • Symbol DS3478
  • Symbol DS6608
All bar code readers which are supported by Microsoft Windows 95.
DatabaseClient Server database structureClient Server database structure
Operating System: ServersMicrosoft Windows XPMicrosoft Windows NT version 4.0
Operating System: ClientMicrosoft Windows 2000Microsoft Windows 98

 

FeatureMEDITECH Client Server 5.6 Other Technological CharacteristicsMEDITECH Client Server 5.1 Other Technological Characteristics
Application LanguageMAGIC proprietary languageMAGIC proprietary language
User Interface: Workstation softwareMAGIC menu structure and a redesigned graphical user interface including user desktops
MAGIC CS Connect allows users to sign on in 2-tier or 3-tier modes
MAGIC menu structure and user interface
ArchitectureHighly scalableHighly scalable
PlatformsClient ServerClient Server
SecuritySecurity by User / Security by Location: Users must supply ID and password when prompted. User access to specific functions is controlled based on role and responsibility. Audit trails based on user activity.Security by User / Security by Location: Users must supply ID and password when prompted. User access to specific functions is controlled based on role and responsibility. Audit trails based on user activity.

 

Software development tools and methods are standardized for MAGIC and Client Server platforms.

FeatureMEDITECH Client Server 5.6 Life Cycle CharacteristicsMEDITECH MAGIC 4.9 Life Cycle Characteristics
Project FeasibilityMEDITECH Proposal SystemMEDITECH Proposal System
RequirementsMEDITECH Proposal SystemMEDITECH Proposal System
Design and DevelopmentMEDITECH Development Design Project System (DDP)MEDITECH Design ControlMEDITECH Design Control Sub-system
Configuration ManagementMEDITECH Development Tracking SystemMEDITECH Development Tracking System
Unit TestingVerification of functional requirements performed by testers in the Development DepartmentVerification of functional requirements performed by testers in the Development Department
Alpha TestingFull system test performed using detailed validation guides covering all critical functionsFull system test performed using detailed validation guides covering all critical functions
Beta User Site TestingTesting for each new release performed at user sites using detailed validation guides covering all critical functionsTesting for each new release performed at user sites using detailed validation guides covering all critical functions
Maintenance24 hour/day, 365 days/year customer service24 hour/day, 365 days/year customer service

 

B.1 In-House Testing (Unit Test and Alpha Test)

The design and use of the software was evaluated for hazards, verified and validated at multiple phases throughout the development and implementation. Verification, testing, and validation was performed at the unit level, the integration level, and at the alpha (in-house) level.

The objective of the unit test and the alpha system test is to ensure that the Blood Bank software fulfills its intended use and meets all safety critical requirements. Testing is performed in three phases.

  • Unit testing of individual changes is performed in a controlled testing environment as part of the design controls to ensure that potential hazards have been mitigated and that the design fulfills the software requirements. Each unit test case is traceable to the software requirements and hazards identified.
  • A fully integrated test of the total HCIS is executed in a simulated hospital testing environment at the end of each service release. The test cases are designed based on the baseline requirements and updated to reflect all enhancements being introduced.
  • The alpha test is performed in a separate controlled environment to evaluate the Blood Bank software’s performance under simulated user conditions. The alpha test cases were written using defined expected results based on the software design specifications. Each alpha test case is traceable to the software design specifications.
 In-House Unit TestProduction TestIn-House Alpha TestTotal
Total Test Cases70490125919
Initial Test Case Failures1153111157
Test Case Failures On Re-test0000

Testing at the unit level is part of the development coding process. Testing revealed 115 failures. All moderate and high severity failures were corrected immediately.

The testing at the application level and the alpha level revealed a low number of failures. Each failure was reviewed and evaluated in terms of impact on safety, effectiveness, and intended use. All safety critical failures reported during system and beta testing have been corrected. Verification and validation activities met the acceptance criteria. No new safety or effectiveness issues were raised.

 

B.2 User Site Testing and Validation

The software was tested and validated at six customer sites, on the customers’ hardware and operating systems.

The objective of user-site testing is to provide objective evidence that the MEDITECH Blood Bank software could be used safely and effectively by the end-users.

These independent tests are designed simulate Blood Banking activity using all major functional features of the Blood Bank software for Client Server release 5.6 beta release version.

Software developers were directly involved in assisting with the validation at the user sites. Customer support was provided by staff from the Implementation and the Development divisions. Blood Bank Technicians at user sites performed testing of the features they intend to use in the live environment. MEDITECH provided testing scripts to utilize as the basis for testing. MEDITECH installed Client Server 5.6 software as part of the normal implementation process, set up the user site's test database, with the site's actual hardware, parameter settings, and dictionaries, to simulate the Blood Bank's actual clinical dataset and environment.

The Blood Bank Technicians performed testing simulations, using the scripts provided. In addition, bases on their knowledge and experience, they performed additional testing based on their standard operating procedures and workflow. If they found any software anomalies or situations which did not meet their requirements, they reported the concerns. MEDITECH staff evaluated each report in terms of impact on safety, effectiveness, and intended use.

MEDITECH staff performed testing for any features that the beta customers do not intend to use in their live environment. This testing was intended to cover any requirements that the users’ testing did not cover.

The resources required for user-site validation included:

Site:2-6 customer sites using Blood Bank software
Hardware:An allowable hardware configuration, including servers, terminals, printers.
Databases:Minimum requirement: NPR, MIS, ADM, MRI, LAB
Personnel:10-12 MEDITECH applications specialist
1-4 MEDITECH programmer/analyst
1-3 Blood Bank Technicians at each user site

 

Conclusions of User-Site Testing

The table below shows the number of tests performed, initial failures encountered, and failures on re-test after corrections.

 ROMSLTWEGEXENRRDOHTotal
Test Cases executed by the Customer29471685048225
Test Case executed by Meditech staff6300014077
Total Test Cases924716851448302
Initial Test Case Failures203210200486
Test Case Failures On Re-test0000000

 

The user-site validations revealed a low number of critical safety failures. Each failure was reviewed and evaluated in terms of impact on safety, effectiveness, and intended use. All critical safety failures reported during user-site testing have been corrected. Verification and validation activities met the acceptance criteria. No new safety or effectiveness issues were raised

 

B3. Conclusions of Non-Clinical and Clinical Testing

A summary of the results of MEDITECH in-house testing (non-clinical) and user-site testing (clinical) is shown below.

 In-House TestingUser Site Beta TestTotal
Total Test Cases9193021221
Initial Test Case Failures15786243
Test Case Failures On Re-test000

Both the non-clinical and clinical testing revealed a low number of initial failures, averaging approximately 20%. Each failure was reviewed and evaluated in terms of impact on safety, effectiveness, and intended use. All critical safety failures reported during system and beta testing have been corrected. Verification and validation activities met the acceptance criteria. No new safety or effectiveness issues were raised.

 

C.1. Conclusions of Safety and Effectiveness

Based on the above comparisons, the results of testing, and use of controlled processes for design, development, configuration, verification, validation, and testing, the Client Server Blood Bank version 5.6 has met expectations for a safe and effective product, is fit for its intended use, and is substantially equivalent to its predicate devices.

Dean Lamsa
July 1, 2008