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									                                                                                                                                         VISN 23 ICU-CIS Requirements
                                                                                                                                                      October 29, 2008

        Category           Sub-category               Element                                                        Mandatory   Mandatory      Vendor Response
                                                                                                                       (ICU)      (PACU)
1.0     National VISN
        System
        Requirements
1.1                        VISN-Centric National      Must Demonstrate following Requirements Prior to               Mandatory   Mandatory
                           Database                   Contractual Obligation with VISN                                 (ICU)      (PACU)
                           Implementation
1.1.1                                                 The database definitions must be identical within all          Mandatory   Mandatory
                                                      hospitals across the VISN. All database and template             (ICU)      (PACU)
                                                      modifications may be entered only once and propagated
                                                      as coordinated within the VISN to all facilities. Individual
                                                      hospital databases must have the ability to prevent local
                                                      modifications.




1.1.2                                                 Vendors must provide a mechanism whereby VISN or               Mandatory   Mandatory
                                                      nationally-directed changes in the database and/or user          (ICU)      (PACU)
                                                      templates can be pushed out to all facilities throughout the
                                                      VISN level. A mechanism(s) must be provided to prevent
                                                      changes to flowsheet template and database elements
                                                      that might be mandated by the VISN or VA nationally for
                                                      purposes of standardization.
1.1.3                                                 The ability to create new database elements, controlled at     Mandatory   Mandatory
                                                      the VISN level, must be maintained. Note: this must not          (ICU)      (PACU)
                                                      prevent the ability to assign informational lines (e.g.,
                                                      specific templates or assessments), unique for the
                                                      management of a specific patient, for use at the individual
                                                      facility level and to be included in the patient‘s permanent
                                                      medical record.
1.2                        Security and Reliability   Systems must meet all VA security requirements as well         Mandatory   Mandatory
                                                      as ensure data against system failures (disaster recovery).      (ICU)      (PACU)




1.2.1                                                 Reliable and robust application able to survive network and    Mandatory   Mandatory
                                                      server failures without loss of data or of real-time data        (ICU)      (PACU)
                                                      display.




Nat'l Mandatory Elements                                                              1 of 31
                                                                                                                                        VISN 23 ICU-CIS Requirements
                                                                                                                                                     October 29, 2008

        Category           Sub-category              Element                                                        Mandatory   Mandatory      Vendor Response
                                                                                                                      (ICU)      (PACU)
1.2.2                                                Provide plans to ensure ICU-CIS production and database        Mandatory   Mandatory
                                                     server redundancies for hospital/VISN including network          (ICU)      (PACU)
                                                     failures.
1.2.3                                                Systems must have a method for ensuring the tracking of
                                                     user input (audit trails).
1.3                        Data Extracts             Must Demonstrate following Requirements Prior to               Mandatory   Mandatory
                                                     Contractual Obligation with VISN                                 (ICU)      (PACU)
1.3.1                                                A data extraction system for ALL clinical and                  Mandatory   Mandatory
                                                     administrative data in the ICU-CIS database must be              (ICU)      (PACU)
                                                     capable of creating data extracts at least every 4 hours
                                                     without degrading performance of ICU-CIS. (CLIN 003-
                                                     3—See "Data Extraction" Tab on this spreadsheet for
                                                     extract requirements.)
1.3.2                                                The files must be in XML, ASCII flat files, or HL7 format.     Mandatory   Mandatory
                                                                                                                      (ICU)      (PACU)
1.3.3                                                Real time data from patient monitors, infusion pumps,
                                                     ventilators, assist devices, etc. extracted from the ICU-CIS
                                                     at frequencies independent of the display time period and
                                                     in accordance with Data Extraction requirements Tab on
                                                     this spreadsheet.
1.4                        Data Standardization                                                                     Mandatory   Mandatory
                                                                                                                      (ICU)      (PACU)
1.4.1                                                ICU-CIS data dictionary must meet all VA nomenclature          Mandatory   Mandatory
                                                     and standardization requirements. The ICU-CIS software           (ICU)      (PACU)
                                                     must use the most updated terminology consistent with
                                                     Uniform Data Dictionary, and/or Systematized
                                                     Nomenclature of Medicine, Clinical Terms (SNOMED CT),
                                                     and ICD-9, vocabulary throughout the contact period.




1.5                        VistA Interface           Must Demonstrate following Requirements Prior to               Mandatory   Mandatory
                           Functionality             Contractual Obligation with VISN                                 (ICU)      (PACU)
1.5.1                                                All required interfaces (see Interface Section, 4.0) with      Mandatory   Mandatory
                                                     VistA must be certified prior to contract signing and            (ICU)      (PACU)
                                                     installation in VISN 23.
1.6                        Remote Access and Off- ICU-CIS application must support remote view capabilities         Mandatory   Mandatory
                           line Viewing           that allow one or more complete records to be viewed at             (ICU)      (PACU)
                                                  the same time from within the hospital outside of the ICU
                                                  and from outside hospital utilizing VPN and Citrix. When
                                                  remotely accessing the CIS from within the hospital, the
                                                  user should be able to have full functionality of the CIS.




Nat'l Mandatory Elements                                                            2 of 31
                                                                                                                              VISN 23 ICU-CIS Requirements
                                                                                                                                           October 29, 2008

          Category         Sub-category     Element                                                       Mandatory   Mandatory      Vendor Response
                                                                                                            (ICU)      (PACU)
1.6.1                                       One or more clinically active ICU-CIS records must be         Mandatory   Mandatory
                                            able to be viewed entirely by authorized users or               (ICU)      (PACU)
                                            administrators on remote, non-clinical workstations via the
                                            local area network (LAN). Access to ICU-CIS records by
                                            remote workstations must be via a browser-based
                                            application or a special viewing program.
1.6.2                                       All off-site performance monitoring of ICU-CIS hardware or    Mandatory   Mandatory
                                            software must satisfy VA Cyber-Security Requirements,           (ICU)      (PACU)
                                            the Administrative Simplification provisions of the Health
                                            Insurance Portability and Accountability Act of 1996
                                            (HIPAA), and the provisions of The Privacy Act of 1974
                                            and its Veterans Affairs applications.

1.6.3                                       Remote support of the ICU-CIS server or workstation           Mandatory   Mandatory
                                            software that is accomplished by the manufacturer through       (ICU)      (PACU)
                                            remote access must satisfy VA Cyber-Security
                                            Requirements, preserve firewalls, and meet Enterprise
                                            Architecture Standards and VA security guidelines for
                                            virus protection. An audit trail of all remote access must
                                            be maintained.
1.6.3.1                                     Software or hardware upgrades must not disrupt or alter a     Mandatory   Mandatory
                                            clinically active ICU-CIS record. An audit trail of all         (ICU)      (PACU)
                                            software changes must be maintained. All upgrades must
                                            be coordinated with COTR.
1.8                        VistA/CPRS       ICU-CIS application must not interfere with VA approved       Mandatory   Mandatory
                           Compatibility    programs (including the following)                              (ICU)      (PACU)
                                            • BCMA
                                            • VISTA/CPRS
                                            • VISTA Imaging
                                            • Internet Browser
                                            • Microsoft Offices Products
                                            • Java/Active X-Plug Ins
                                            • SMS
                                            • McAfee Virus Scan
                                            • ISS Proventia firewall
                                            • Sentillion Vergence Locator
                                            • Analytic Database
                                            • ARK remote view
                                            • Brit PACS
                                            • Employee Assists Program
                                            • Windows 2000 Professional or Windows XP
                                            • Employee Education LMS system

1.9                        Implementation   Implementation program must be specifically designed for      Mandatory   Mandatory
                                            VISN 23 to leverage system knowledge and efficiencies           (ICU)      (PACU)




Nat'l Mandatory Elements                                                  3 of 31
                                                                                                                                    VISN 23 ICU-CIS Requirements
                                                                                                                                                 October 29, 2008

        Category           Sub-category          Element                                                        Mandatory   Mandatory      Vendor Response
                                                                                                                  (ICU)      (PACU)
1.10                       Maintenance program   A uniform, multi-year maintenance program must be an           Mandatory   Mandatory
                                                 available option for VISN 23 and must include all                (ICU)      (PACU)
                                                 application upgrades, new versions, patches, etc. This
                                                 program must ensure that all VISN 23 sites are using the
                                                 same ICU-CIS version.
1.11                       Device Drivers        Device drivers to all VA medical devices for patient use in    Mandatory   Mandatory
                                                 OR, ICU, PACU, etc. must be capable of accepting all             (ICU)      (PACU)
                                                 data, measured and calculated. These drivers must be
                                                 available without additional cost to all VISN 23 sites for
                                                 existing and new equipment added to the VISN 23
                                                 inventory.
1.12                       Device Features       Once properly accessed, ICU-CIS workstations must have         Mandatory   Mandatory
                                                 the capability to toggle (foreground/background                  (ICU)      (PACU)
                                                 continuous functionality) between the ICU-CIS applications
                                                 and other software applications used within VISN 23 (see
                                                 1.8 for examples).
2.0     System
        Requirements and
        characteristics

2.1                        Interoperability      Must Demonstrate following Requirements Prior to
                                                 Contractual Obligation with VISN
2.1.1                                            ICU-CIS applications in every clinical monitoring location     Mandatory   Mandatory
                                                 [i.e. ICU, PACU] must provide interoperability capabilities      (ICU)      (PACU)
                                                 by either one of two methods below:

                                                 A) By joining data from diverse sources through
                                                 capabilities to interface with an Analytic Database, sending
                                                 images to VistA Image and using a 'remote view' mode
                                                 from the alternate ARK,

                                                 or

                                                 B) By an automatic and seamless exchange of data within
                                                 a hospital 1) to permit clinical review of all data at any
                                                 location in the hospital, 2) to provide integration of
                                                 continuing care data (fluids, drips, medications, etc.), and
                                                 3) to allow complete analyses of clinical care.




Nat'l Mandatory Elements                                                        4 of 31
                                                                                                                                     VISN 23 ICU-CIS Requirements
                                                                                                                                                  October 29, 2008

       Category            Sub-category            Element                                                       Mandatory   Mandatory      Vendor Response
                                                                                                                   (ICU)      (PACU)
2.2    Technical           Workstation             Applications must be able to be run on the typical VA         Mandatory   Mandatory
       Requirements and    Requirements for ICU-   workstation hardware as listed below. Any requirements          (ICU)      (PACU)
       characteristics     CIS                     that deviate from this standard must be clearly outlined.
                                                   Contractors will however be required to submit a list of
                                                   equipment required which will include the minimum
                                                   requirement for the ICU-CIS and Interface Software to
                                                   operate at an efficient level as intended. The list of this
                                                   equipment (including estimated pricing for each individual
                                                   item suggested) shall be provided with this signed
                                                   proposal and shall be included as defined in "Hardware
                                                   Requirements" Tab on this Spreadsheet.


3.0    Network
       Requirements
3.1                                                ICU-CIS client application workstation shall be able to be    Mandatory   Mandatory
                                                   run with a standard 100 full duplex network connection to       (ICU)      (PACU)
                                                   the ICU-CIS server. The Contractor is required to submit
                                                   with his/her signed proposal, a list of any additional
                                                   network resources that are required for any associated
                                                   ICU-CIS connection. The above must be clearly outlined
                                                   and included with the Contractor‘s response as
                                                   Attachment D, Exhibit 1, Item 3. The VA shall provide all
                                                   necessary network hardware to meet this connection
                                                   speed.
3.2                                                 The ICU-CIS Contractor shall provide a listing of port and   Mandatory   Mandatory
                                                   protocols used by the ICU-CIS system and include in             (ICU)      (PACU)
                                                   Attachment D, Exhibit 1, Item 3.
3.3                                                The ICU-CIS software shall be able to be run on PC            Mandatory   Mandatory
                                                   located on the hospital domain.                                 (ICU)      (PACU)
3.4                                                The ICU-CIS system shall be able to operate over VISN         Mandatory   Mandatory
                                                   23's WAN. Contractor shall ensure that VISN 23, should it       (ICU)      (PACU)
                                                   choose to, will be able to operate servers at remote
                                                   locations for decreased hardware maintenance. A
                                                   diagram of the existing VISN 23 WAN is included in this
                                                   RFP.

3.5                                                The CIS software shall have ability to operate off a WAN      Mandatory   Mandatory
                                                   link with common intra VISN network latencies of up to 30       (ICU)      (PACU)
                                                   mS and VPN latencies of up to 100 mS




Nat'l Mandatory Elements                                                         5 of 31
                                                                                                                                              VISN 23 ICU-CIS Requirements
                                                                                                                                                           October 29, 2008

          Category             Sub-category                   Element                                                     Mandatory   Mandatory      Vendor Response
                                                                                                                            (ICU)      (PACU)
4.0       Required Medical     VHA will provide a uniform
                               interface across all VISNs
          Device and VistA
                               and hospitals to share
          Interface            information between VistA
          Requirements         and CIS used for the ICU,
          (Note: vendor must   ARK, PACU and
          demonstrate          Anesthesia Preop. The
                               interface primarily will use
          following            HL7 communications as
          requirements prior   well as VistA Broker Calls
          to contractual       (APIs). The vendor side of
          obligation with      the interfaces must be
                               developed, tested,
          VISN.)
                               implemented and
                               supported according to
                               VHA standards provided
                               by Document Storage
                               Systems (DSS), 12575 US
                               Hwy 1, Suite 200, Juno
                               Beach, FL 33408, 561-227-
                               0207. DSS will provide
                               programming
                               specifications and
                               development support upon
                               request.




4.0.1                          a. Medical Device
                               Interfaces (HL7 and
                               General Medical
                               Device Interfaces)
4.0.1.1                                                       ICU-CIS device drivers or other electronic communication    Mandatory   Mandatory
                                                              means to all VA medical devices for patient use must be       (ICU)      (PACU)
                                                              capable of accepting all data, measured and calculated.

4.0.1.2                                                       Provide direct connect or HL7 networked interfaces to all   Mandatory   Mandatory
                                                              VISN 23 site's physiologic monitoring systems and             (ICU)      (PACU)
                                                              medical devices for VISN 23 including all systems and
                                                              devices listed in Attachment E.




Nat'l Mandatory Elements                                                                    6 of 31
                                                                                                                                       VISN 23 ICU-CIS Requirements
                                                                                                                                                    October 29, 2008

          Category         Sub-category           Element                                                          Mandatory   Mandatory      Vendor Response
                                                                                                                     (ICU)      (PACU)
4.0.1.4                                           Additional medical device interfaces of the make/model           Mandatory   Mandatory
                                                  listed in Attachment E may be required as new equipment            (ICU)      (PACU)
                                                  is identified for interfacing to the ICU-CIS. These medical
                                                  device interfaces will be developed and provided at no
                                                  charge to the VA upon request of the VISN 23 COTR. If
                                                  however, interfaces are required for make/model devices
                                                  not listed in Attachment E, additional charges may apply.
                                                  The Contractor shall provide a written description of
                                                  Contractor's approach to adding additional medical device
                                                  interfaces and estimated pricing, if any, as defined in the
                                                  exhibit instructions.


4.0.1.5                                           Applications collecting data from medical devices shall run      Mandatory   Mandatory
                                                  as a background service and shall not require a user to be         (ICU)      (PACU)
                                                  interactively logged into the computer to collect the data.

4.0.2                      b. VistA Interfaces
                           Government Furnished
                           Property
4.0.2.1                                           Overview: The Contractor must provide interfaces to              Mandatory   Mandatory
                                                  solve the problem of electronic documentation, continuum           (ICU)      (PACU)
                                                  of care, advance clinical access, and clinical workflow in
                                                  critical care areas. The interfaces will exchange data bi-
                                                  directionally between VistA/CPRS and ICU-CIS
                                                  applications. The interface is a key element in the
                                                  creation of an electronic medical record for the critical care
                                                  areas.
4.0.2.2                                           The Government will furnish the appropriate interfaces to        Mandatory   Mandatory
                                                  operate on the VistA systems. These interfaces are                 (ICU)      (PACU)
                                                  referred to as the VistA-side interfaces. That is, they
                                                  provide only one half of the interface requirements. The
                                                  successful Contractor will be responsible to provide the
                                                  other half, (the vendor-side) as part of this contract. The
                                                  Contractor shall coordinate the above with the Primary
                                                  COTR and will work with either VA staff and/or third party
                                                  Contractor to make a successful connection and transfer
                                                  of data with the VistA system through the Government
                                                  provided interface. If costs are incurred by the third party
                                                  to properly make the necessary interface connection(s)
                                                  operate correctly with the products provided by this
                                                  contract, it is the Contractor‘s responsibility to cover those
                                                  costs.




Nat'l Mandatory Elements                                                         7 of 31
                                                                                                                                          VISN 23 ICU-CIS Requirements
                                                                                                                                                       October 29, 2008

          Category         Sub-category                  Element                                                      Mandatory   Mandatory      Vendor Response
                                                                                                                        (ICU)      (PACU)
4.0.2.3                                                  For this particular contract and the products being          Mandatory   Mandatory
                                                         acquired, the VistA-side interfaces have been developed        (ICU)      (PACU)
                                                         by a third party. That company is Document Storage
                                                         Systems (DSS), 12575 US Hwy 1, Suite 200, Juno Beach,
                                                         FL 33408, 561-227-0207.

4.0.3                      c. Description of
                           Integration
                           Requirements
4.0.3.1                                                  The functional integration requirements needed to meet       Mandatory   Mandatory
                                                         VHA requirements are listed below. The VA-side of the          (ICU)      (PACU)
                                                         VistA interface will be provided to the successful ICU-CIS
                                                         Contractor for the ICU-CIS. The ICU-CIS Contractor will
                                                         be required to have a VistA testing environment, QA staff,
                                                         and provide installation, training and support of the ICU-
                                                         CIS interface.
4.1                        d. Vendor Side
                           Integration Interface
                           Components (CLIN
                           003-2)

4.1.a                      User Authentication
                           (Security) — For every
                           sign-on vendor software
                           will use the VA master list
                           to validate users and user
                           rights for the clinical
                           application through VistA
                           Broker Calls.
4.1.1                                                    1. Purpose: To provide a single sign-on source for all       Mandatory   Mandatory
                                                         vendors using the VA master list permitting clinical users     (ICU)      (PACU)
                                                         access to an ICU-CIS using only VA passwords.

4.1.2                                                    2. Description:                                              Mandatory   Mandatory
                                                                                                                        (ICU)      (PACU)
4.1.2.1                                                  a. Users will sign-on to ICU-CIS using their VistA           Mandatory   Mandatory
                                                         access/verify codes in a logon dialog box with asterisks       (ICU)      (PACU)
                                                         (***) displayed for both codes.
4.1.2.2                                                  b. A separate authentication system is not maintained in     Mandatory   Mandatory
                                                         the ICU-CIS for standard logons. A shadow list may be          (ICU)      (PACU)
                                                         employed for use only when the network or CPRS is down
                                                         utilizing VA security standards. All changes in VA
                                                         access/verify codes must be used immediately for
                                                         subsequent ICU-CIS authentications.




Nat'l Mandatory Elements                                                               8 of 31
                                                                                                                              VISN 23 ICU-CIS Requirements
                                                                                                                                           October 29, 2008

          Category         Sub-category   Element                                                         Mandatory   Mandatory      Vendor Response
                                                                                                            (ICU)      (PACU)
4.1.2.3                                   c. A successful logon through VistA returns the user‘s          Mandatory   Mandatory
                                          VistA credentials to the ICU-CIS, including — but not             (ICU)      (PACU)
                                          limited to — user class, title, service, ICU-CIS
                                          administrator.
4.1.2.4                                   d. The user group credentials will determine users‘             Mandatory   Mandatory
                                          privileges within the ICU-CIS. The ICU-CIS application will       (ICU)      (PACU)
                                          allow creation of a ―user group‖ and assign user groups
                                          specific levels of ICU-CIS access, such as 'read/write',
                                          'read-only', specific template access privileges.

4.1.2.5                                   e. The ICU-CIS may determine a user‘s user group by             Mandatory   Mandatory
                                          querying the Vista interface for the user group(s) that a         (ICU)      (PACU)
                                          user is assigned to.
4.1.2.6                                   f. The Vista interface determines the user group using          Mandatory   Mandatory
                                          ―rules‖ based upon the user‘s keys, title, and/or ASU user        (ICU)      (PACU)
                                          class. Each site must also create keys matching the ICU-
                                          CIS user group name.
4.1.2.7                                   g. Rules defining user groups are included with this            Mandatory   Mandatory
                                          interface and individual VISNs may create their own as            (ICU)      (PACU)
                                          well.
4.1.2.8                                   h. If the logon is unsuccessful, the user may not gain          Mandatory   Mandatory
                                          further access to the application. (Logons will be limited to     (ICU)      (PACU)
                                          a fixed number of failed attempts, e.g., <10.)
4.1.2.9                                   i. A temporary ‗work around‘ must become available to           Mandatory   Mandatory
                                          allow users to logon only if network access is not available.     (ICU)      (PACU)
                                          As soon as the network is available—and it is feasible
                                          clinically—user must logon to the ICU-CIS by the standard
                                          method.
4.1.2.1                                   j. Electronic Signature data will be sent to ICU-CIS to allow   Mandatory   Mandatory
0                                         provider signing in ICU-CIS, including notes and records          (ICU)      (PACU)
                                          signed in ICU-CIS prior to sending to VistA.




Nat'l Mandatory Elements                                                 9 of 31
                                                                                                                                             VISN 23 ICU-CIS Requirements
                                                                                                                                                          October 29, 2008

           Category        Sub-category                   Element                                                        Mandatory   Mandatory      Vendor Response
                                                                                                                           (ICU)      (PACU)
4.2                        Patient Selection /
                           Registration in ICU-CIS
                           — Individual patients will
                           be selected by methods
                           conforming to VistA
                           standards, minimizing data
                           entry, and by a process
                           similar to patient selection
                           in CPRS. Note: the
                           selection of patients must
                           occur through a VistA
                           query utilizing VistA Broker
                           calls (APIs).




4.2.1                                                     1. Purpose: To accurately select individual patients and       Mandatory   Mandatory
                                                          send patient specific information to the ICU-CIS with            (ICU)      (PACU)
                                                          updates triggered by the ICU-CIS and VistA as necessary.
                                                          VistA identity management procedures are maintained and
                                                          extended within the ICU-CIS.
4.2.2                                                     2. Description:

4.2.2.1                                                   a. Patients will be selected from within ICU-CIS by multiple   Mandatory   Mandatory
                                                          methods including the following:                                 (ICU)      (PACU)
4.2.2.1.                                                  i. from a list in ICU-CIS, which must be updated               Mandatory   Mandatory
1                                                         contemporaneously from ADT messages or poling the                (ICU)      (PACU)
                                                          Surgery Schedule when appropriate,
4.2.2.1.                                                  ii. utilizing a GUI similar to CPRS patient selection (e.g.,   Mandatory   Mandatory
2                                                         initial + ―last 4 SSN‖, Teams, wards),                           (ICU)      (PACU)
4.2.2.1.                                                  iii. scanning patient‘s barcode, when it becomes available
3
4.2.2.1.                                                  iv. a ‗John Doe‘ option permitting use of the ICU-CIS          Mandatory   Mandatory
4                                                         without first requiring patient registration in VistA (see       (ICU)      (PACU)
                                                          section e. below),
4.2.2.2                                                   b. Patient identification information consists of multiple     Mandatory   Mandatory
                                                          identifiers and the ICU-CIS patient identification process       (ICU)      (PACU)
                                                          must meet VA standards (ENTR888 and ENTR942:
                                                          vendor transactions/messages from or to VistA shall be
                                                          capable of including the source identifiers within all
                                                          messages that exchange data with other VHA systems.)




Nat'l Mandatory Elements                                                                10 of 31
                                                                                                                                             VISN 23 ICU-CIS Requirements
                                                                                                                                                          October 29, 2008

           Category        Sub-category               Element                                                            Mandatory   Mandatory      Vendor Response
                                                                                                                           (ICU)      (PACU)
4.2.2.3                                               c. Upon registration of a valid patient in the ICU-CIS, the        Mandatory   Mandatory
                                                      patient information will be sent to ICU-CIS triggered by             (ICU)      (PACU)
                                                      multiple events including query from ICU-CIS, ADT
                                                      message, surgery schedule message or patient
                                                      information update. The patient information, to be updated
                                                      in ICU-CIS, will include, not limited to, patient identification
                                                      identifiers, patient demographics, Code Status, CWAD,
                                                      bed location, treating specialty, etc..
4.2.2.3.                                              i. New messages to ICU-CIS are sent for updates to the             Mandatory   Mandatory
1                                                     patient data stored when MPI updates data in VistA. ICU-             (ICU)      (PACU)
                                                      CIS must update its database with the new data
                                                      contemporaneously.
4.2.2.3.                                               ii. CWAD (Clinical Warnings and Advanced Directives) will         Mandatory   Mandatory
2                                                     accompany patient registration/ADT messages, as well as              (ICU)      (PACU)
                                                      provide a ‗re-send message‘ trigger when information is
                                                      updated. If Patient Record Flags (Category 1 and 2) exist
                                                      in VistA, transmit to ICU-CIS for display including any
                                                      changes/updates during that episode of care.

4.2.2.3.                                               iii. For each patient, ICU-CIS must accept VISN/hospital          Mandatory   Mandatory
3                                                     specific team names, ICU locations (e.g., bed names) and             (ICU)      (PACU)
                                                      treating specialty names, (e.g., PACU, Pre-Op, Holding,
                                                      OR) to correctly identify patient locations and clinical
                                                      provider groups/teams.
4.2.3                                                 d. Procedures must be included to allow the emergent,              Mandatory   Mandatory
                                                      manual entry of patient demographics entered into the ICU-           (ICU)      (PACU)
                                                      CIS prior to Registration through ADT in VistA. Easy
                                                      identification and resolution of any differences once VistA
                                                      registration is accomplished must be facilitated by ICU-
                                                      CIS.

4.2.4                                                 e. There must be a simple, reliable method to retroactively        Mandatory   Mandatory
                                                      match duplicate identities stored within both systems with           (ICU)      (PACU)
                                                      ‗John Doe‘ or incorrect patient assignments to prevent the
                                                      creation of duplicate patient records in ICU-CIS.

4.3                        Patient Status
                           Information — Allergies
                           and Code Status
                           information is sent with
                           initial registration of
                           patient in ICU-CIS and
                           with all updates to
                           Status content.




Nat'l Mandatory Elements                                                              11 of 31
                                                                                                                                           VISN 23 ICU-CIS Requirements
                                                                                                                                                        October 29, 2008

          Category         Sub-category                 Element                                                        Mandatory   Mandatory      Vendor Response
                                                                                                                         (ICU)      (PACU)
4.3.1                                                   A) Allergies — Current allergies in VistA are in separate      Mandatory   Mandatory
                                                        messages. A complete allergy set will be sent with a ICU-        (ICU)      (PACU)
                                                        CIS query, bed control (AO) or surgery scheduling (SR)
                                                        accompanied by pharmacy orders (ORM) based upon
                                                        actions within the CPRS, bed control or surgery scheduling
                                                        system, as well as patient registration in ICU-CIS.

4.3.2                                                   2.    Purpose: To provide allergy data stored in VistA for     Mandatory   Mandatory
                                                        display in ICU-CIS.                                              (ICU)      (PACU)
4.3.3                                                   3.    Description:                                             Mandatory   Mandatory
                                                                                                                         (ICU)      (PACU)
4.3.3.1                                                 a.    A read-only set of allergy data is sent in ICU-CIS for   Mandatory   Mandatory
                                                        display-only.                                                    (ICU)      (PACU)
4.3.3.2                                                 b.    Allergy messages are triggered by event changes          Mandatory   Mandatory
                                                        managed in VistA. (ICU-CIS query, ADT, surgery                   (ICU)      (PACU)
                                                        schedule, pharmacy orders, patient registration in ICU-
                                                        CIS, or modifications to allergy data)

4.3.3.3                                                 c.   Allergy updates made in VISTA must be updated             Mandatory   Mandatory
                                                        automatically and in real-time in the ICU-CIS. Changes           (ICU)      (PACU)
                                                        must be displayed in ICU-CIS both as a 'new' or 'critical'
                                                        data alert and in an updating data field.
4.4                        Patient Information —In
                           general, patient data are
                           sent based upon 1) on a
                           process external to the
                           package (‘trigger’), 2) an
                           update or addition to the
                           package information, or
                           3) a query generated by
                           the ICU-CIS. Queries
                           may have multiple
                           parameters set to define
                           ranges of interest and
                           typically utilize VistA
                           Broker Calls (APIs).
                           (NOTE: Where
                           appropriate, all patient
                           data must be displayed
                           on timelines in the ICU-
                           CIS at the correct times
                           in graphic and tabular
                           formats.)
4.4.1                                                   A) Lab Results — All verified lab ORM HL7 messages             Mandatory   Mandatory
                                                        will be sent to ICU-CIS including microbiology.                  (ICU)      (PACU)

4.4.1.1                                                 1.   Purpose: To send hematology, microbiology, blood          Mandatory   Mandatory
                                                        bank and chemistry lab results to the ICU-CIS.                   (ICU)      (PACU)



Nat'l Mandatory Elements                                                              12 of 31
                                                                                                                              VISN 23 ICU-CIS Requirements
                                                                                                                                           October 29, 2008

          Category         Sub-category   Element                                                         Mandatory   Mandatory      Vendor Response
                                                                                                            (ICU)      (PACU)
4.4.1.2                                   2. Description:                                                 Mandatory   Mandatory
                                                                                                            (ICU)      (PACU)
4.4.1.3                                   a1.    Hematology and chemistry lab results will be sent        Mandatory   Mandatory
                                          from VistA Laboratory package to ICU-CIS for display.             (ICU)      (PACU)
                                          No limitations can be placed on maximum number of
                                          laboratory data (specific tests or numbers of test results).

4.4.1.4                                   a2. Microbiology and blood bank, including entire culture       Mandatory
                                          reports and antibiotic sensitivities, must be displayed. All      (ICU)
                                          parent / child reports must be included with each update.

4.4.1.5                                   b.    ‗Out of range‘ and ‗critical value‘ labels will           Mandatory   Mandatory
                                          accompany results as appropriate. ICU-CIS must accept             (ICU)      (PACU)
                                          and display these data.
4.4.1.6                                   c.    Results formats will be modified to permit ICU-CIS to     Mandatory   Mandatory
                                          display logical categories (e.g., CBC panel) rather than just     (ICU)      (PACU)
                                          alphabetical order.
4.4.1.7                                   d.    Query capabilities initiated by ICU-CIS will mimic        Mandatory   Mandatory
                                          CPRS (date range, specific results, etc.)                         (ICU)      (PACU)
4.4.1.8                                   e. Changes must be displayed in ICU-CIS both as a               Mandatory   Mandatory
                                          'new' or 'critical' data alert and in an updating data field.     (ICU)      (PACU)

4.4.2                                     B) Pharmacy Medication Schedules and                            Mandatory
                                          Administration — All medications will be sent to ICU-             (ICU)
                                          CIS including include both outpatient and inpatient
                                          medications.
4.4.2.1                                   1.   Purpose: To send medications schedules and                 Mandatory
                                          administration to the ICU-CIS for display-only.                   (ICU)
4.4.2.2                                   2.   Description:                                               Mandatory
                                                                                                            (ICU)
4.4.2.3                                   a1.    Pharmacy medication schedules, outpatient re-fills.      Mandatory
                                                                                                            (ICU)
4.4.2.4                                   a2.     Inpatient administration events contained in BCMA       Mandatory
                                          will be sent contemporaneously to ICU-CIS for read only           (ICU)
                                          use
4.4.2.5                                   b.     Verified and cancelled order messages will be            Mandatory
                                          included.                                                         (ICU)
4.4.2.6                                   c.     Queries capabilities initiated by ICU-CIS will mimic     Mandatory
                                          CPRS (date range, specific results, etc.)                         (ICU)
4.4.2.7                                   d.     All order modifications will be made                     Mandatory
                                          contemporaneously in VistA and CPRS.                              (ICU)
4.4.2.8                                   e.     VA Formulary will be sent to ICU-CIS.                    Mandatory
                                                                                                            (ICU)
4.4.2.9                                   f.    Changes must be displayed in ICU-CIS both as a            Mandatory
                                          'new' or 'critical' data alert and in an updating data field.     (ICU)




Nat'l Mandatory Elements                                                  13 of 31
                                                                                                                               VISN 23 ICU-CIS Requirements
                                                                                                                                            October 29, 2008

          Category         Sub-category   Element                                                          Mandatory   Mandatory      Vendor Response
                                                                                                             (ICU)      (PACU)
4.4.3                                     C) Nursing and Dietary Orders — All Nursing and                  Mandatory
                                          Dietary Orders will be sent to ICU-CIS in delimited                (ICU)
                                          form when available (e.g., restraint orders, pressure
                                          ulcer, fall risk).
4.4.3.1                                   1. Purpose: Nursing and Dietary orders will be sent to           Mandatory
                                          provide treatment schedules in ICU-CIS.                            (ICU)
4.4.3.2                                   2. Description:                                                  Mandatory
                                                                                                             (ICU)
4.4.3.3                                   a. Nursing and Dietary orders will be sent to ICU-CIS for        Mandatory
                                          read-only use.                                                     (ICU)
4.4.3.4                                   b. All order modifications will be made in VistA and             Mandatory
                                          contemporaneously displayed in ICU-CIS. Changes must               (ICU)
                                          be displayed in ICU-CIS both as a 'new' or 'critical' data
                                          alert and in an updating data field.
4.4.4                                     D) Radiology Orders — All radiology orders will be sent          Mandatory
                                          to CIS.                                                            (ICU)
4.4.4.1                                   1. Purpose: radiology orders will be sent to facilitate          Mandatory
                                          nursing schedules in CIS.                                          (ICU)
4.4.4.2                                   2. Description:                                                  Mandatory
                                                                                                             (ICU)
4.4.4.3                                   a. Radiology orders will be sent to ICU-CIS for read-only        Mandatory
                                          use.                                                               (ICU)
4.4.4.4                                   b. All order modifications will be made in VistA and             Mandatory
                                          contemporaneously displayed in ICU-CIS. Changes must               (ICU)
                                          be displayed in ICU-CIS both as a 'new' or 'critical' data
                                          alert and in an updating data field.
4.4.5                                     E) Vital Signs — Vital signs will be sent to ICU-CIS.            Mandatory   Mandatory
                                                                                                             (ICU)      (PACU)
4.4.5.1                                   1. Purpose: A record of the complete patient vital sign          Mandatory   Mandatory
                                          information from VISTA (including O2 saturation and pain           (ICU)      (PACU)
                                          scores, as available) will be sent to the ICU-CIS..
4.4.5.2                                   2. Description:                                                  Mandatory   Mandatory
                                                                                                             (ICU)      (PACU)
4.4.5.3                                   a. Vital sign data will be sent to the ICU-CIS for use by        Mandatory   Mandatory
                                          clinicians.                                                        (ICU)      (PACU)
4.4.5.4                                   b. Updated data will be sent to the ICU-CIS.                     Mandatory   Mandatory
                                                                                                             (ICU)      (PACU)
4.4.6                                     F) Problem List — Current Problem List entries will to           Mandatory
                                          be sent to ICU-CIS.                                                (ICU)
4.4.6.1                                   1.   Purpose: The Problem List contain information on            Mandatory
                                          current patient problems that may be valuable in                   (ICU)
                                          assessing patients.
4.4.6.2                                   2.   Description:                                                Mandatory
                                                                                                             (ICU)
4.4.6.3                                   a. The problem list is sent initiated by the standard triggers   Mandatory
                                          and modifications to the list.                                     (ICU)
4.4.6.4                                   b. ICD-9 codes will be included.                                 Mandatory
                                                                                                             (ICU)




Nat'l Mandatory Elements                                                 14 of 31
                                                                                                                                           VISN 23 ICU-CIS Requirements
                                                                                                                                                        October 29, 2008

          Category         Sub-category                Element                                                         Mandatory   Mandatory      Vendor Response
                                                                                                                         (ICU)      (PACU)
4.4.7                                                  G) Notification of New Messages — A ‗Notification‘              Mandatory
                                                       message will identify all new messages sent to CIS.               (ICU)
4.4.7.1                                                1.    Purpose: The Notification message will be used by         Mandatory
                                                       the ICU-CIS to alert the clinical user of new messages            (ICU)
                                                       received by the CIS. The ICU-CIS will display the
                                                       message type in efficient and easily comprehensible
                                                       methods for clinical users (e.g., color coded icon indicating
                                                       'new labs', 'out of range labs', 'new orders').

4.4.7.2                                                2.   Description:                                               Mandatory
                                                                                                                         (ICU)
4.4.7.3                                                a. When a new message is created, a second,                     Mandatory
                                                       ‗Notification‘ message is sent also to the ICU-CIS                (ICU)
                                                       identifying alerts, new lab values, etc.
4.4.7.4                                                b. The ICU-CIS will use the information in the Notification     Mandatory
                                                       message to inform the clinical user of receipt of new data.       (ICU)

4.4.7.5                                                c. The ICU-CIS will display a 'connection interrupted'          Mandatory
                                                       message obvious to the clinical provider within 5 minutes         (ICU)
                                                       of a communication interruption ( VistA, DSS, or network
                                                       failure) between the ICU-CIS and VistA.
4.5                        Time Synchronization —
                           The times in the ICU-CIS
                           systems must be
                           synchronized with VistA.

4.5.1                                                  1.   Purpose: To have an accurate medical record the            Mandatory   Mandatory
                                                       ICU-CIS clocks must be identical to the VistA time.               (ICU)      (PACU)

4.5.2                                                  2.   Description:                                               Mandatory   Mandatory
                                                                                                                         (ICU)      (PACU)
4.5.2                                                  a.     The ICU-CIS must receive a timing signal from the        Mandatory   Mandatory
                                                       interface and the synchronize the ICU-CIS time with the           (ICU)      (PACU)
                                                       VistA time.
4.6                        VistA Imaging — A .Pdf
                           image is sent from ICU-
                           CIS to VistA Imaging will
                           be associated with a TIU
                           note.

4.6.1                                                  1. Purpose: Since dense data and many data types                Mandatory   Mandatory
                                                       cannot be stored in VistA, the ICU-CIS must create an             (ICU)      (PACU)
                                                       image file for permanent, medical record storage in VistA.

4.6.2                                                  2. Description:                                                 Mandatory   Mandatory
                                                                                                                         (ICU)      (PACU)




Nat'l Mandatory Elements                                                             15 of 31
                                                                                                                                                 VISN 23 ICU-CIS Requirements
                                                                                                                                                              October 29, 2008

          Category              Sub-category               Element                                                           Mandatory   Mandatory      Vendor Response
                                                                                                                               (ICU)      (PACU)
4.6.2.1                                                    a. Images of the ICU flowchart, PACU record, and                  Mandatory   Mandatory
                                                           anesthesia record will be created and sent to VistA                 (ICU)      (PACU)
                                                           Imaging by the ICU-CIS at both pre-determined and user-
                                                           defined intervals for permanent display and storage.

4.6.2.2                                                    b. The images will be attached to a TIU note title and            Mandatory   Mandatory
                                                           administratively signed. Must be able to attach provider            (ICU)      (PACU)
                                                           signature, when required.
4.6.2.3                                                    c. Similar to paper flow sheets and records, the images           Mandatory   Mandatory
                                                           display the initials of the individual who entered a particular     (ICU)      (PACU)
                                                           value. The individual‘s full name is displayed as a legend
                                                           on the form.
4.6.2.4                                                    d. PDF is the required format.                                    Mandatory   Mandatory
                                                                                                                               (ICU)      (PACU)
4.7                             TIU (Progress Note) — A
                                progress note is created
                                in the ICU-CIS and sent
                                to VistA.
4.7.1                                                      1. Purpose: A TIU note signed by the clinician is created         Mandatory   Mandatory
                                                           in ICU-CIS and placed in CPRS Progress Notes.                       (ICU)      (PACU)

4.7.2                                                      2. Description:                                                   Mandatory   Mandatory
                                                                                                                               (ICU)      (PACU)
4.7.2.1                                                    a. Progress notes created within ICU-CIS will be exported         Mandatory   Mandatory
                                                           to CPRS for permanent display and storage in VistA                  (ICU)      (PACU)
                                                           Progress Notes.
4.7.2.2                                                    b. The note may be reviewed, edited and electronically            Mandatory   Mandatory
                                                           signed in VistA. It may also be signed in the ICU-CIS or            (ICU)      (PACU)
                                                           administratively signed in VistA. The capability for both
                                                           approaches are required in the ICU-CIS.
4.7.2.3                                                    c. All elements in the progress note are configurable by          Mandatory   Mandatory
                                                           the site.                                                           (ICU)      (PACU)
4.7.2.4                                                    d. Electronic signatures applied in ICU-CIS along with the        Mandatory   Mandatory
                                                           signed progress note will be transmitted to VistA.                  (ICU)      (PACU)
4.7.2.5                                                    e. Electronic signature information will be                       Mandatory   Mandatory
                                                           accessed/validated in VistA at the time of signing into ICU-        (ICU)      (PACU)
                                                           CIS.
5.0       Additional ICU-CIS                               THE FOLLOWING CLINICAL ASSESSMENT
          Clinical Assessment                              APPLICATIONS REQUIRE A RESPONSE AS TO
                                                           WHETHER YOUR SYSTEM HAS THE CAPACITY TO
          Capabilities
                                                           ACCOMPLISH THE DESCRIBED ACTION.
                                                           Describe in detail and/or provide screen capture images
                                                           demonstrating how your application accomplishes the
                                                           desired action(s).
5.0.1                                                      Patient name and SSN must be prominently displayed on             Mandatory   Mandatory
                                                           every page of the electronic display and record images.             (ICU)      (PACU)




Nat'l Mandatory Elements                                                                  16 of 31
                                                                                                                                             VISN 23 ICU-CIS Requirements
                                                                                                                                                          October 29, 2008

        Category           Sub-category               Element                                                            Mandatory   Mandatory      Vendor Response
                                                                                                                           (ICU)      (PACU)
5.1                        Document body system                                                                          Mandatory   Mandatory
                           assessments                                                                                     (ICU)      (PACU)
5.1.1                                                 The capability to document body system assessments                 Mandatory   Mandatory
                                                      sufficient to provide the Unit with a detailed head-to-toe           (ICU)      (PACU)
                                                      assessment that is configurable to each Unit, level of care,
                                                      facility and groups of patients e.g. liver transplant or open
                                                      heart.
5.1.3                                                 The ICU-CIS must include severity scales. Severity scales          Mandatory   Mandatory
                                                      must be calculated automatically (with mandatory manual              (ICU)      (PACU)
                                                      data elements, as required), such as Apache II, III and IV,
                                                      APS, Braden, Aldrete, Glascow coma scale, Morse fall
                                                      scale, nutrition scoring, etc. as well as locally created
                                                      scores.
5.2                        Manage calculations and                                                                       Mandatory   Mandatory
                           calculated data                                                                                 (ICU)      (PACU)
5.2.2                                                 The ability to perform manual and automatic clinical               Mandatory   Mandatory
                                                      calculations                                                         (ICU)      (PACU)
5.3                        Enter data and conduct                                                                        Mandatory   Mandatory
                           fluid balance                                                                                   (ICU)      (PACU)
                           management
5.3.1                                                 The ability of clinicians on different shifts to enter data into   Mandatory   Mandatory
                                                      a system that is capable of distinguishing fluids (blood,            (ICU)      (PACU)
                                                      drips, IV fluids, etc.) and manage continuous fluid balance
                                                      calculations inclusive of unit stay.



5.3.2                                                 The ability to identify net negative I/O . The ability to          Mandatory   Mandatory
                                                      calculate net negative I/O and total I/O. Ability to auto            (ICU)      (PACU)
                                                      calculate I‘s and O‘s (data displayed by tables, variable
                                                      time periods, graphically, separated into colloid,
                                                      crystalloid, blood // urine, NG, chest tube, etc.) Ability to
                                                      see totals of Is and Os hourly, every 8 hr, every 24 hr, and
                                                      length of stay
5.3.3                                                 The ability to document all blood product administration as        Mandatory   Mandatory
                                                      individual components.                                               (ICU)      (PACU)

5.4                        Intuitive user interface                                                                      Mandatory   Mandatory
                                                                                                                           (ICU)      (PACU)
5.4.1                                                 The user interface should be easy and implicit: colors,            Mandatory   Mandatory
                                                      icons, graphs, pick lists, freeform text, notes, forms, point        (ICU)      (PACU)
                                                      and click, drop and drag, copy and paste and other
                                                      normalized Word-type capabilities are critical to reducing
                                                      errors.
5.4.2                                                 The user interface must be compliant with Section 508 of           Mandatory   Mandatory
                                                      the Disabilities Act.                                                (ICU)      (PACU)
5.5                        Charting Capabilities                                                                         Mandatory   Mandatory
                                                                                                                           (ICU)      (PACU)


Nat'l Mandatory Elements                                                              17 of 31
                                                                                                                               VISN 23 ICU-CIS Requirements
                                                                                                                                            October 29, 2008

         Category          Sub-category   Element                                                          Mandatory   Mandatory      Vendor Response
                                                                                                             (ICU)      (PACU)
5.5.1                                     Step-down units: configurable fields and views according         Mandatory   Mandatory
                                          to unit.                                                           (ICU)      (PACU)
5.5.2                                     Ability to 'force' selection of entries from pick-lists to       Mandatory   Mandatory
                                          minimize free-text                                                 (ICU)      (PACU)
5.5.3                                     Ability to add structured notes for procedures, H&P,             Mandatory   Mandatory
                                          patient problems (i.e., to facilitate SOAP or PIE charting)        (ICU)      (PACU)
                                          etc.
5.5.4                                     A method must be in place that will allow the user to            Mandatory   Mandatory
                                          annotate artifactual data, with an audit trail of corrected        (ICU)      (PACU)
                                          data maintained. If the ICU-CIS has data-averaging
                                          capabilities, an audit trail of automatic corrections must
                                          also be maintained.
5.5.5                                     Ability to print q-shift and other summary reports               Mandatory   Mandatory
                                                                                                             (ICU)      (PACU)
5.5.6                                     Create, setup and manage administrations of infusions            Mandatory   Mandatory
                                          and complex drips                                                  (ICU)      (PACU)
5.5.7                                     Ability to auto calculate I‘s and O‘s (data displayed by         Mandatory   Mandatory
                                          tables, variable time periods, graphically, separated into         (ICU)      (PACU)
                                          colloid, crystalloid, blood // urine, NG, chest tube, etc.)
5.5.8                                     Display tabular and graphical values (including from CPRS        Mandatory   Mandatory
                                          with vital signs, laboratory values, and other data)—all on        (ICU)      (PACU)
                                          the same timeline

5.5.9                                      The ability to display I/O balance (preferably graphically)     Mandatory   Mandatory
                                          over a user selected time period.                                  (ICU)      (PACU)
5.5.10                                    Ability to easily configure the flowchart to the individual      Mandatory   Mandatory
                                          patient, i.e., add or subtract rows as patient condition           (ICU)      (PACU)
                                          changes
5.5.11                                    Ability to document The Joint Commission patient safety          Mandatory   Mandatory
                                          standards such as critical alarm settings, restraints, patient     (ICU)      (PACU)
                                          education, etc.




Nat'l Mandatory Elements                                                 18 of 31
                                                                                                                                                              VISN 23 ICU-CIS Requirments
                                                                                                                                                                          October 29, 2008


Ref.        Category              Sub-category                    Element                                                             Mandatory   Mandatory       Vendor Response
                                                                                                                                        (ICU)      (PACU)
7.1.1       Other
            requirements
7.1.2                             Flexibility                     Vendors must have the ability to configure the system for           Mandatory   Mandatory
                                                                  various areas where VISN 23 may or will implement (i.e.               (ICU)      (PACU)
                                                                  ICU, PACU, ED, small facilities, large tertiary care facilities).

7.1.3                                                             System must have a method for guarding against user                 Mandatory   Mandatory
                                                                  errors to protect data format (i.e. numbers vs. text).                (ICU)      (PACU)
7.1.4                             Fields of input                                                                                     Mandatory   Mandatory
                                                                                                                                        (ICU)      (PACU)
7.1.5                             Network Requirements            ICU-CIS Contractor shall evaluate each site‘s network               Mandatory   Mandatory
                                                                  capabilities. If ICU-CIS client will not run optimally on             (ICU)      (PACU)
                                                                  existing LAN/WAN, ICU-CIS Contractor must inform VA as
                                                                  to the necessary hardware and/or software that will enable
                                                                  the Contractor‘s equipment to work optimally.

7.1.6                             Additional ICU-CIS Clinical     ICU-CIS shall have the capability for charted assessments           Mandatory   Mandatory
                                  Assessment Capabilities/        to yield calculated scores.                                           (ICU)      (PACU)
                                  Document body system
                                  assessments
7.1.7                              Additional ICU-CIS Clinical    ICU-CIS Contractor must provide personnel resources to              Mandatory   Mandatory
                                  Assessment Capabilities/        actively aid in the creation and configuring of our master            (ICU)      (PACU)
                                  Export/import configuration     database.
                                  elements of an application to
                                  same vendor application
7.1.8                                                             ICU-CIS workstations must be able to operate with non-              Mandatory   Mandatory
                                                                  proprietary hardware, including central processing units              (ICU)      (PACU)
                                                                  (CPUs), keyboards, pointing devices (e.g. mice, light pens,
                                                                  track balls, or touch screens), and computer monitors.

7.1.9                                                             Easy for users to configure screens, for example to change          Mandatory   Mandatory
                                                                  font size, without assistance from technical staff.                   (ICU)      (PACU)

7.1.10                            Configuration of Record         Ability to enter and view CPRS and VISTA data while                 Mandatory   Mandatory
                                  Templates                       simultaneously logged onto the ICU-CIS system.                        (ICU)      (PACU)
7.1.11                                                            Easy to learn and intuitive to use. Descriptions of functions       Mandatory   Mandatory
                                                                  rather than lots of icons. Minimum of steps.                          (ICU)      (PACU)
7.1.12                                                            ICU-CIS shall have the ability to integrate with other              Mandatory   Mandatory
                                                                  information systems such as Real Time Location Systems                (ICU)      (PACU)
                                                                  (e.g. RFID), tracking, electronic grease boards through
                                                                  industry standard formats.




Add'l Mand Elements for VISN 23                                                              19 of 31
                                                                                                                                          VISN 23 ICU-CIS Requirments
                                                                                                                                                      October 29, 2008


Ref.        Category              Sub-category   Element                                                          Mandatory   Mandatory       Vendor Response
                                                                                                                    (ICU)      (PACU)
7.1.12.1                                         Ability to configure the appearance of the ICU-CIS (what the     Mandatory   Mandatory
                                                 user actually sees) so that the information which we deem to       (ICU)      (PACU)
                                                 be most important can be viewed on a single screen.

7.1.13                                           Vendor must be on-site at each facility for testing phases       Mandatory   Mandatory
                                                 prior to go-live and for the initial go live period.               (ICU)      (PACU)
7.1.14                                                                                                            Mandatory   Mandatory
                                                 Clear audit trail for corrected data.                              (ICU)      (PACU)
7.1.15                                           Ability to ―restore‖ previous charting data if patient           Mandatory   Mandatory
                                                 inadvertently discharged from CIS                                  (ICU)      (PACU)
7.1.16                                           Ability to view flowsheet ―rolled up‖ by Q4h, Q8h, Q12h,         Mandatory
                                                 Q24h, etc.                                                         (ICU)


7.1.17                                           Flowsheet viewing and documentation at exact time (down          Mandatory   Mandatory
                                                 to the minute)                                                     (ICU)      (PACU)
7.1.18                                           Ability to build flow sheets within the master sheet i.e. Skin   Mandatory   Mandatory
                                                 care, epidural, PCA flow sheets.                                   (ICU)      (PACU)
7.1.19                                           Ability to edit entries until a specified period of time has     Mandatory   Mandatory
                                                 passed.                                                            (ICU)      (PACU)
7.1.20                                           Ability to control location of added rows–by someone with        Mandatory   Mandatory
                                                 the appropriate privileges in the CIS.                             (ICU)      (PACU)
7.1.21                                           Ability to select groups of charting rows as a family for        Mandatory   Mandatory
                                                 standards of care i.e. Ventilator family, post open heart          (ICU)      (PACU)
                                                 family, insulin drip family, VAP family, etc.
7.1.23                                           Configuration Editor does not require programming (i.e.          Mandatory   Mandatory
                                                 language) knowledge but instead includes built in GUI tools        (ICU)      (PACU)

7.1.24                                           Create, select and score assessments against various             Mandatory   Mandatory
                                                 criteria                                                           (ICU)      (PACU)

                                                 Criteria should include BCMA medication delivery data, Lab
                                                 data, Vitals data, I&O data etc.; and other standard scoring
                                                 systems like CIWA, MASS, Ramsey, etc.

7.1.25                                           All validated data will be available on the Pdf whether as       Mandatory   Mandatory
                                                 actual time by time entries or as footnotes where more than        (ICU)      (PACU)
                                                 one value per hour is present.




Add'l Mand Elements for VISN 23                                            20 of 31
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Ref.        Category              Sub-category   Element                                                             Mandatory   Mandatory       Vendor Response
                                                                                                                       (ICU)      (PACU)
7.1.26                                                                                                               Mandatory   Mandatory
                                                 Documentation of body assessments must include the                    (ICU)      (PACU)
                                                 ability to copy forward from the last assessment. Copied
                                                 forward data can be accepted with minimal effort. Copied
                                                 forward data can be edited before storage. Entries can be
                                                 edited even if stored up to a fixed cut off time (12-24 hours)
                                                 selectable by unit, facility, or VISN. Each unit, facility or the
                                                 VISN can select automatic or manual charting. Back entry
                                                 of data where received from devices or manual entry is
                                                 allowable up to the fixed cut off time as selected by unit.
                                                 facility or VISN.

7.1.27                                           When there is a break in stay (transfer to ward with return at      Mandatory   Mandatory
                                                 a later date), the CIS clearly defines the I/O balances for           (ICU)      (PACU)
                                                 only the current stay, yet the previous stay balances are
                                                 reviewable.
7.1.28                                           Users may add annotation to any cell, field, where data is          Mandatory   Mandatory
                                                 manually entered or automatically downloaded from a                   (ICU)      (PACU)
                                                 device. Annotations clearly identify the author.




Add'l Mand Elements for VISN 23                                              21 of 31
                                                                                                                                                                                 VISN 23 ICU-CIS Requirements
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Ref.        Category                Sub-category                          Elements                                                                                            Vendor Response


1.13         National VISN System Workstation Provider/Patient Devices
             Requirements

1.13.1                                                                    Does your ICU-CIS include input capabilities from Bar-Code readers, Swipe-card readers,
                                                                          Real Time Location Systems, Biometric (fingerprint) identifiers, or others? Describe examples
                                                                          of your implementations.
3.0          System Components

3.1                                 Hardware                              Please recommend workstation configurations that incorporate good human factors
                                                                          engineering, and based on your experience, promote effective and safe use (considering
                                                                          aspects such as ergonomics, flexibility, space requirements, display monitors, input devices,
                                                                          etc.)
3.2                                 The ICU-CIS and Associated Networks
3.2.2                                                                     Identify networking infrastructure that you would expect each hospital and the VISN to provide
                                                                          for your system implementation to operate well
3.2.3                                                                     Identify any network hardware and software expertise you would expect the VA to provide for
                                                                          your system implementation to operate well.
3.2.4                                                                     Describe your experience deploying in a wireless network environment.
3.3                                 ICU-CIS Application Suite
3.3.1                                                                     If your ICU-CIS consists of a suite of applications or software options, describe each.
3.3.2                                                                     If applicable, please discuss the applications most commonly purchased.
3.3.3                                                                     If applicable, are there applications that other VA‘s do not commonly purchase? Describe.

3.4                                 ICU-CIS Database
3.4.2                                                                     What physiologic/device data are stored in your database? At what maximum frequency? Are
                                                                          the data stored permanently? What data is available for queries?
3.4.6                                                                     The VISN and/or the vendor shall have the ability to add calculated variable fields to the
                                                                          database.
3.4.7                                                                     The database shall have the ability to have new fields added to the database once ICU-CIS is
                                                                          in clinical use.
3.4.7.1                                                                   Please describe the procedure for adding fields using specific examples.
                                                                          Can new fields be calculated fields?
                                                                          How are all workstations updated with new fields?
3.4.10                                                                    The ICU-CIS shall minimizes the amount of 'free text' entries and shall be site configurable
                                                                          and shall allow text/numeric entries to have range limits, formats (numeric versus letters, etc.)
                                                                          or other control mechanisms. (E.g., drop-down menus, pick lists, check boxes.) List all
                                                                          fields/locations that only accept free text entries.
3.4.10.1                                                                  What programming languages may be used to generate reports from your ICU-CIS database?
                                                                          Please provide examples of reports and how those reports are queried.
3.4.10.2                                                                  Please provide examples of your canned reports. What type of privileged user(s) typically
                                                                          initiate reports? List examples. Can pre-defined/canned queries be modified?

3.4.10.3                                                                  How are new report queries created? What type of privileged user(s) typically initiate queries?
                                                                          Can new computed/derived variables be created for reports?
3.4.10.4                                                                  What reports can be displayed graphically?
3.4.15                                                                    Describe the options for backing-up your ICU-CIS data. What is provided by the Contractor
                                                                          with the ICU-CIS? What is the VA responsible to furnish?
3.4.16                                                                    Describe your solution for archiving your ICU-CIS data. Include data density, granularity and
                                                                          storage requirement size relationships.
3.4.17                                                                    Specify backup media provided with the system. Can the system be archived and/or backed-
                                                                          up to a network attached storage system (NAS) or storage area network (SAN)?




Desirable Elements ICU-CIS                                                              22 of 31
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3.5                                ICU-CIS Technical Capabilities

3.5.3                                                                               Describe the relationship between your system server(s) and number of care units,
                                                                                    workstations, users that can be simultaneously supported.
3.5.8                                                                               Can application software (Patient and Remote) be pushed out to PC(s) or must it be loaded at
                                                                                    each individual workstation?
3.5.8.1                                                                             Describe recommended hardware as called for in optional CLINs.

3.5.17                                                                              Please indicate approximate range of data traffic levels (based on predictions of normal client
                                                                                    loads) on the ICU-CIS and associated networks.
3.5.19                                                                              Describe your requirements for IP addresses including total number of addresses
                                                                                    (approximate).
3.5.20                                                                              Describe possible ICU-CIS and associated networks and/or server failures. What would and
                                                                                    would not be affected by those failures?
3.5.21                                                                              Describe if ICU-CIS client application workstation shall be able to be run with a standard 100
                                                                                    MB full duplex network connection to the ICU-CIS server. The Contractor is required to
                                                                                    submit a list of any additional network resources that are required for any associated ICU-CIS
                                                                                    connection. The above must be clearly outlined and included with the Contractor‘s response
                                                                                    as Exhibit 1, Item 3. The VA shall provide all necessary network hardware to meet this
                                                                                    connection speed.
3.5.22                                                                              The ICU-CIS Contractor shall provide a listing of port and protocols used by the ICU-CIS
                                                                                    system and include in the exhibits.
3.5.24                                                                              Describe your system's self monitoring tools. How are network failures (including
                                                                                    performance degradation) identified by your system? How does your ICU-CIS notify the
                                                                                    system manager of failures? What does your ICU-CIS workstation display when a network
                                                                                    failure occurs? Describe or attach additional information.

3.5.25                                                                              Supply a flow chart/block diagram depicting the flow of data under usual operating conditions.

3.5.26                                                                              Include a diagram that illustrates all network components including hubs, routers, switches,
                                                                                    servers, etc.
4.2          Interfaces            Patient Selection in CIS — Individual patients
                                   will be selected by methods conforming to
                                   industry standards, minimizing data entry, and
                                   by a process similar to patient selection in
                                   CPRS.
4.2.2.1.5                                                                           Does your ICU-CIS support CCOW integration? If so, please describe and include in your
                                                                                    proposal. List reference sites that have implemented CCOW with your application.

5.4          Additional ICU-CIS    Intuitive user interface                         THE FOLLOWING CLINICAL ASSESSMENT APPLICATIONS REQUIRE A RESPONSE AS
             Clinical Assessment                                                    TO WHETHER YOUR SYSTEM HAS THE CAPACITY TO ACCOMPLISH THE DESCRIBED
                                                                                    ACTION.
             Capabilities
                                                                                    Describe in detail and/or provide screen capture images demonstrating how your application
                                                                                    accomplishes the desired action(s).
5.5                                Charting Capabilities                            The ICU-CIS shall:
5.5.12                                                                              Does your ICU-CIS have the ability to store, display and extract monitor/device data
                                                                                    permanently at rates of 1 minute or less?
5.5.13                                                                              Does your ICU-CIS have the ability to simultaneously capture, store and export both high
                                                                                    resolution data (<=1 min in PACU ) as well as 'validated' data.
5.5.16                                                                              ICU-CIS must be capable of capturing physiological waveforms including date/time annotation.
                                                                                    Any necessary hardware to accommodate the monitoring system specifics in Attachment E
                                                                                    should be defined.
                                                                                    Provide evidence that your system has the ability to display and store waveforms from patient
                                                                                    monitors. Provide information on your systems‘ ability to import digital images of waveforms,
                                                                                    etc. Provide reference contacts who are using your method of managing ECG strips.




Desirable Elements ICU-CIS                                                                        23 of 31
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5.5.17                                                                        Describe the ability to view various sections of the flow sheet by tabbing to them, i.e. Cardiac
                                                                              assessment, neuro assessment, respiratory assessment, nursing care provided, procedures,
                                                                              treatments.
5.5.18                                                                        Describe the ability to view various sections on the screen simultaneously, e.g.; vital sign,
                                                                              vasoactive drips and I & O all at once. Provide an example.
5.5.19                                                                        Describe Printout capabilities and options
5.5.20                                                                        Describe Progress Note creation (auto entries, selections of entries during creation, multiple
                                                                              types of notes, etc.) in ICU-CIS to be sent to VistA and local (VISN) ability to tailor note
                                                                              content.
5.5.21                                                                        Describe how two or more users can chart on the same patient in the same time period.

5.6                          Desirable ICU-CIS Clinical Assessment
                             Capabilities
5.6.2                                                                         Does your ICU-CIS have the ability to accept and plot calculated data from medical devices?
                                                                              Does your system have the ability to ‗pull‘ data from all devices affecting the patient, including
                                                                              (after the fact) emergency data?
5.1                          Document body system assessments                 The ICU-CIS shall:
5.2                          Manage calculations and calculated data
5.8.2                                                                         Describe the capability of your ICU-CIS to provide clinical reminders and alerts or
                                                                              notifications. Can these reminders be date or time driven? Can they be site specific or area
                                                                              specific?

                                                                              Does your system have a method for alerting staff when a charting action needs to be
                                                                              performed? Do such alerts include incomplete charting (e.g. pain charting was missed BID
                                                                              dressing change missed.)
5.9                          Describe the ability of the system to
                             Create/modify and monitor patient care
                             protocols and reminders for clinical
                             management
5.9.1                                                                         Describe any designated mandatory field alerts and required action item entry.
5.9.2                                                                         Alert provider of incomplete patient compliance measures/protocols
5.9.3                                                                         Allow individual unit systems managers to customize their ICU-CIS with alert date driven
                                                                              reminders (when to change IV sites, etc.)
5.9.4                                                                         Describe ability of the ICU-CIS to update and display patient care and disease management
                                                                              protocols
5.9.5                                                                         Describe the ability to have configurable ALERTS (e.g. Ventilator Days > #; Aspiration
                                                                              precautions; Restraint checks; LOS for multidisciplinary conferences)
5.10                         Export/import configuration elements of an
                             application to same vendor application

5.10.1                                                                        Describe your ability and approach to making database modifications, which can then be
                                                                              propagated to other hospitals.
5.10.2                                                                        Describe in your software how new software versions maintain pre-existing structural elements
                                                                              without corruption.
5.11                         Describe the ability of your system to Capture
                             and store multi-disciplinary service
                             documentation, including the following
                             example situations
5.11.1                                                                        Capture and store multi-disciplinary service care (Respiratory Services, Physical therapy,
                                                                              Occupational Therapy, Nutrition Service, Social work, Chaplin, ethics, BCMA Data review,
                                                                              etc.).
5.14                         Patient data summaries
5.14.1                                                                        Describe how multi-patient (rounds) summaries to be customizable for both nurses and
                                                                              physicians and be able to print copies.




Desirable Elements ICU-CIS                                                                   24 of 31
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5.16                         Unlimited configuration abilities of families,
                             rows, columns
5.16.1                                                                         Do end users have the ability to access descriptors, pick list length, clinical pathways (i.e.
                                                                               carotid), flow sheets, number of forms, and change font size, color, backgrounds, size etc.
                                                                               should be user defined.
5.19                         Conduct analysis and decision support for care
                             providers
5.19.1                                                                         Provide descriptions and examples of your decision support tools, including multiple data
                                                                               points from a robust decision engine.
5.20                         Describe the ability of your system to meet the
                             following features
5.20.4                                                                         Does the ICU-CIS have the ability to ―default‖ previously charted values into next charting cell
                                                                               for acceptance or manually change.
5.20.8                                                                         Can graphs be defined on by users as needed with selectable variables and timelines?

                                                                               Can users select multiple colors for flow sheets and graphs?

                                                                               Provide instructions on how a user steps through this process.

5.20.12                                                                        Can flow sheet elements be grouped into logical subgroups (ABGs, CBC, etc)?
5.20.13                                                                        Can rows with no data in the viewable time range be collapsed (hidden)?
5.20.16                                                                        Can the ICU-CIS indicate by color change individual tabular values that are out of range. (VA
                                                                               lab ranges must be utilized.)
5.20.20                                                                        Describe how all IV fluids, drug infusions included, are entered and tracked in your ICU-CIS.
                                                                               Include screen shots.
5.20.22                                                                        Do you have a separate I&O chart view? What is included? Is any I&O excluded? Include
                                                                               screen shots.
5.21                         Administrative/Utilization Functions
5.21.3                                                                         Nurse and other provider assignments change each shift and also temporarily. Describe your
                                                                               audit trails for tracking these changes?

                                                                               How can users verify that the correct ICU-CIS record is displayed for the correct patient?

5.21.10                                                                        How does your ICU-CIS manage provider verification of different flowsheet/template
                                                                               components (e.g., nursing and RT)?
5.21.10.1                                                                      Do you have an option to enter free text into a template cell?
5.21.15                                                                        How does your ICU-CIS handle an 'event'? (E.g. for cardiac arrest 'events' can ECG strips,
                                                                               treatments, and flowsheet information be associated together?)

                                                                               Can automatically populated fields be configured to require care nurse validation?
5.21.17                                                                        Describe your on-line help screens. Are help screens configurable?
5.22                         Clinical Applications Coordinator (CAC)
5.22.1                                                                         Please describe your recommendations for VISN 23 personnel resources to support both
                                                                               clinical and technical functions. Include recommended prior experiences, clinical and technical
                                                                               capabilities, and hours/week required during both initial implementation and routine
                                                                               operational periods.
5.22.3                                                                         Describe/list what clinical components (calculated cells, views, variables, forms, tables,
                                                                               variables, etc.) that VA personnel can design. Include examples of the design processes. Do
                                                                               you have a ‗VA‘ pre-defined setup of tables, variable, forms that a VISN could use?

5.22.9                                                                         What is the effective learning time before a VA super-user can start designing sheets?
5.22.15                                                                        Are there VA or non-VA user groups for your ICU-CIS product (numbers of participants,
                                                                               meetings, purposes, etc.)?
5.22.17                                                                        Please describe the top five, most recent recommended changes or augmentations to your
                                                                               ICU-CIS program obtained from your user groups.




Desirable Elements ICU-CIS                                                                    25 of 31
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5.23                         Vital Signs/Medical Device Interfaces
5.23.4                                                               How can the rate of data storage in ICU-CIS be changed? Can the ICU-CIS data storage rates
                                                                     be driven automatically by events/alarms, nurse options, or other? Please describe.

5.23.7                                                               Do you have a buffer or 'continuous loop', high-density data storage system to recover prior
                                                                     data in the event of an outage of any kind? How long is the temporary storage and what
                                                                     limitations are placed on the stored data?
5.23.9                                                               List reference sites, if any, that have interfaced infusion pumps to your ICU-CIS. Provide
                                                                     make and model of pumps.
5.23.11                                                              Have you interfaced with any medical telemetry systems? Elaborate on your technical
                                                                     solution. Please detail which vendors you have worked with.

5.25                         Maintenance and Warranty
5.25.4                                                               Describe how you would leverage VA technical staff (e.g. Biomedical Engineering) to support
                                                                     system.
5.25.13                                                              How are bundles located? Can we configure where bundles are located in the flow
                                                                     sheet?
5.25.16                                                              Does your ICU-CIS allow for dual entry when dual nurse signature is required? Can
                                                                     two nurses chart on the same patient, in the same cell, and have both authors
                                                                     identified?
5.25.19                                                              Do you have any capability for setting up clinical pathways (e.g. carotid)?
5.25.21                                                              Can a user create a ICU-CIS record on an outpatient (someone who is not admitted
                                                                     and will not be admitted)(e.g. ER)
5.25.22                                                              Describe your ICU-CIS ability to:
                                                                     1. Automatically populate the dose row when the user enters the IV volume
                                                                         row
                                                                     2. Provide defaulting rates* for drip present by volume in I/O section, (e.g.
                                                                         500ml /c drug @ 12cc/hr)
                                                                     3. Provide defaulting dose* for Vitals/Hemodynamic section, (e.g. drug dose
                                                                         @ 6mg/hr)

                                                                     *Meaning that those charting cells will default to the last value entered.

5.25.23                                                              Describe the ICU-CIS capability to provide continuous daily weight change and
                                                                     weight change (from admission weight) over LOS.
5.25.24                                                              Can your system send alerts to a pager?
5.25.26                                                              Describe the process for transferring a record from location to location including
                                                                     within a facility and between facilities.
5.25.29                                                              Please describe how a patient could be transported to a remote procedure, and later
                                                                     have the information from the transport monitor downloaded into the ICU-CIS
                                                                     system to update the ICU-CIS patient chart.
5.25.39                                                              Describe any capabilities for annotating artifactual data, with an audit trail of
                                                                     corrected data maintained. If the ICU-CIS has data-averaging capabilities, an audit
                                                                     trail of automatic corrections must also be maintained.
5.25.41                                                              Does the ICU-CIS allow for restricting the ability to leave a form until required fields
                                                                     are completed?
5.25.63                                                              How can emphasis be placed on important information for a particular day and/or
                                                                     patient (e.g. use of highlighting)?
5.25.68                                                              Describe your levels of user permissioning/access.




Desirable Elements ICU-CIS                                                         26 of 31
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5.25.71                                                      Does the ICU-CIS have the ability to provide expandable ―cells‖ or ability to hover
                                                             over and see full contents of a cell?

5.25.73                                                      Does the ICU-CIS have the capability to store images (i.e. wound pictures).

6.1.0                                                        System is FDA 510(k) Clearance.
6.1.1                                                        Describe your auto charting and manual verification of data before storage.
6.1.2                        Changing the patient location   Please describe the steps required moving a patient from one bed to another bed within the
                                                             same unit.

                                                             Describe the steps for transferring a patient from one unit to another unit within a facility
                                                             and from one facility to another VISN 23 facility.

6.1.3
6.1.4                                                        Can the following information be viewed or input into the ICU-CIS from an ARK? Describe
                                                             any limiting factors (e.g. ARK vendor).

                                                             Total crystalloid
                                                             Blood products
                                                             Colloids
                                                             Urine output
                                                             Estimated blood loss (EBL)
                                                             Lines
                                                             Tubes
                                                             Drainage
6.1.5                                                        Facilities must be able to select which elements of the flowsheet will be stored to the Pdf.
                                                             The VISN will work with the ICU-CIS vendor to configure the layout of the Pdf record.

6.1.6                                                        What are your plans for the ARK to comply with the emerging standards from the IHE Patient
                                                             Care Device Domain?




Desirable Elements ICU-CIS                                                 27 of 31
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Configuration                    Typical                Laptop/Notebook                   Premium          Vendor Response
Processor               2.6 GHz 64-bit              2 GHz (64-bit                 3+ GHz 64-bit (dual core
                                                    recommended)                  processors
                                                                                  recommended)
Memory (RAM)            1 Gb                        1 Gb                          2 Gb
Hard Drive              80 Gb                       80 Gb                         120 Gb
Video Card              PCI Express                 Standard to laptop            PCI 16x
CD-ROM/DVD Drive        16x CD/DVD RW               CD/DVD RW                     16x CD/DVD RW
Monitor                 17” or 19” LCD              Standard to laptop            19” or 22” standard and
                                                                                  wide screen LCD

LAN interface           10/100/1000 remote          10/100/1000 remote wake- 10/100/1000 remote
                        wake-on-LAN Ethernet        on-LAN Ethernet interface     wake-on-LAN Ethernet
                        interface, IPV6 ready       card or docking station, IPV6 interface, IPV6 ready
                                                    ready; Wireless 802.11G/B
                                                    modem

Keyboard                101-key                Standard to laptop                 101-key
Mouse                   MS-compatible Wheel or MS-compatible Wheel or             MS-compatible Wheel or
                        Button Mouse           Button Mouse                       Button Mouse

Sound Card              Windows XP compatible Standard to laptop                  Windows XP compatible
                        sound card                                                sound card

Modem                   Not authorized in most      Not authorized in most cases Not authorized in most
                        cases                                                    cases
Smart Card Reader       Compliant with PC/SC        Compliant with PC/SC         Compliant with PC/SC
                        specifications and ISO      specifications and ISO 7816 specifications and ISO
                        7816 Smart Card             Smart Card Standards; must 7816 Smart Card
                        Standards; must be on       be on Windows Hardware       Standards; must be on
                        Windows Hardware            Compatibility List (HCL).    Windows Hardware
                        Compatibility List (HCL).   Laptop external only.        Compatibility List (HCL).
                        May be internal or                                       May be internal or
                        external.                                                external.

Other                   At least 4 Universal Serial Universal Serial Bus 2 port   At least 4 Universal Serial
                        Bus 2 port (2 with front                                  Bus 2 port (2 with front
                        access)                                                   access)
Operating system        Windows XP                  Windows XP                    Windows XP
                        Windows Vista               Windows Vista                 Windows Vista




Hardware Requirements                                           28 of 31
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                           ICU-CIS Data Extraction Requirements
                                                                                                      Vendor Response
Extracts from ICU-CIS data critical care and OR databases must be in a form suitable for
loading into the VISNs analytic environment; and perform as follows:
§ The extract will include all clinical and administrative data collected and/or displayed by the
clinical information system.
o      The extract allows for all non – continuous data to be exported as stored in the primary 
ICU-CIS database (not from a secondary reporting database).
o      Continuous data will be extracted at a granularity set by the VISN but in any case, not less
frequently than every 60 seconds or the minimum storage interval, whichever is greater. Export
granularity for continuous monitored physiologic data may be as frequent as every 30 seconds.


§     Both validated and unvalidated data will be extracted.
§     The extract exports data on all patients with data in the system database at the time of the
extract regardless of their current status (active vs. discharged).
§ For each data value (observation) stored, the exported observation will include at a minimum
the following associated information, if available in the source ICU-CIS:
o The name of the variable (observation) as listed in the ICU-CIS data dictionary
o Storage format of the data (e.g. varchar, numeric)
o     The data value of the observation
§      if the value is encoded, the decoded value must be provided
o The date and time of the observation
o     Indicator for validated data, if present, and name of person validating
o     Identifier linking the observation to the patient
o     Identifier linking the observation to the hospital encounter (i.e. ICU stay)
o     Identifier linking the observation to the source database (source table key)
o     Name of the source table
o     Name and version of the source ICU-CIS
o The normal range for the value if available in the database
o     The source of the observed data, including
§      physical source (device) or identifier of staff making the observation
§      what is being recorded (electronic source, e.g., HR from ECG)
o     Unit of measurement
o     Patient location (unit and bed) at the time of the observation
§ Every data element will have a patient identifier including, but not limited to, Master Patient
Index and a timestamp, if available. If a timestamp is not available, then the data element will
include a unique key to it's associated encounter. The associated encounter must have a
timestamp.
§ The extract can handle the large volume of data associated with the extraction of very
granular physiologic data (e.g. q30 second heart rates). The extract runs efficiently and can be
run frequently allowing for daily updates from the clinical information system. Data may be
extracted by discharge date range, patient identification number, or date that a field was updated
(if such a date exists in the source ICU-CIS).


§ The extract exports data from the primary ICU-CIS database not a derived reporting database.

§ The extract denormalizes data related to “standardized” entries and the content of “formatted 
field” entries, and “drop down” boxes and their associated fields, and changes.




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§ Export file format will reasonably meet industry standards for XML (preferred methodology),
HL7, or flat file transmission of data. Flat files will be limited to a reasonable number (<50
files total) by combining like data elements into the same file and eliminating unnecessary
duplicates among files.

§ XML or HL7 exports will be grouped per patient with each patient's data in a separate file.
There will be only one file per patient containing all data.

§ Extracts are fully documented.
Extracts must be capable of detecting and extracting changes (edits) to data previously extracted

Extracts must be capable of transmitting the data to the analytics in a manner acceptable to
VISN security requirements (sftp or encrypted transmission is recommended).

Extracted data must be stored in a file folder in a location mutually agreed upon by VISN 23,
ICU-CIS Contractor, and Solution Analytics.




Data Extraction                                            30 of 31
VISN 23 WAN

								
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