Free Customizable Access Database Templates VISN 6 by uhv17931

VIEWS: 413 PAGES: 28

Free Customizable Access Database Templates document sample

More Info
									                                                                                                                                                           VISN 6 ICU CIS Requirements




      Ref.       Category         Sub-category                              Element                           Mandatory(ICU)             Vendor Response
1.0          National VISN
             System
             Requirements
1.1                          VISN-Centric National    Must Demonstrate following Requirements Prior
                             Database                 to Contractual Obligation with VISN                     Mandatory(ICU)
                             Implementation
1.1.1                                                 The database must be identical within all
                                                      hospitals in the same VISN. All database and
                                                      template modifications must be entered only
                                                      once and immediately propagated to all VISN             Mandatory(ICU)
                                                      hospitals. Individual hospital databases and
                                                      templates must be locked to prevent local
                                                      modifications.
1.1.2                                                 Vendors must provide a mechanism whereby
                                                      nationally-directed changes in the database
                                                      and/or user templates can be pushed out to all
                                                      facilities throughout the VISN level. A
                                                      mechanism(s) must be provided to prevent                Mandatory(ICU)
                                                      changes to flowsheet template and database
                                                      elements that might be mandated by the VA
                                                      nationally for purposes of standardization.

1.1.3                                                 The ability to create new database elements,
                                                      controlled at the VISN level, must be
                                                      maintained. Note: this must not prevent the
                                                      ability to assign informational lines (e.g., specific
                                                      templates or assessments), unique for the               Mandatory(ICU)
                                                      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 as ensure data against
                                                                                                              Mandatory(ICU)
                                                      system failures (disaster recovery) and user
                                                      input or errors (audit trail).
1.2.1                                                 Reliable and robust application able to survive
                                                      network and server failures without loss of data        Mandatory(ICU)
                                                      or of real-time data display.
1.2.2                                                 Provide plans to ensure CIS production and
                                                      database server redundancies for
                                                                                                              Mandatory(ICU)
                                                      hospital/VISN/IT region including network
                                                      failures.
1.3                          Data Extracts            Must Demonstrate following Requirements Prior
                                                                                                              Mandatory(ICU)
                                                      to Contractual Obligation with VISN
1.3.1                                                 A data extraction system for ALL clinical and
                                                      administrative data in the CIS database must be
                                                      capable of creating data extracts at least every
                                                      4 hours without degrading performance of CIS.           Mandatory(ICU)
                                                      (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
                                                                                                              Mandatory(ICU)
                                                      format.
1.3.3                                                 Real time data from patient monitors, infusion
                                                      pumps, ventilators, assist devices, etc. must be
                                                      stored and extracted from the CIS at
                                                      frequencies independent of the display time
                                                      period and, in no case, less than every 5
                                                      minutes, preferably at least once per minute.




Nat'l Mandatory Elements                                                                                                       1 of 28
                                                                                                                                   VISN 6 ICU CIS Requirements



1.4                        Data Standardization
                                                                                                        Mandatory(ICU)
1.4.1                                             CIS data dictionary must meet all VA
                                                  nomenclature and standardization
                                                  requirements. The CIS software must use the
                                                  most updated terminology consistent with
                                                  Anesthesia Patient Safety Foundation (APSF),          Mandatory(ICU)
                                                  Uniform Data Dictionary, and/or Systematized
                                                  Nomenclature of Medicine, Clinical Terms
                                                  (SNOMED CT) vocabulary throughout the
                                                  contact period.
1.5                        VistA Interface        Must Demonstrate following Requirements Prior
                                                                                                        Mandatory(ICU)
                           Functionality          to Contractual Obligation with VISN
1.5.1                                             All required interfaces (see Interface Section,
                                                  4.0) with VistA must be certified prior to contract
                                                                                                        Mandatory(ICU)
                                                  signing and installation in VA alpha site

1.6                        Remote Access and      CIS application must support remote view
                           Off-line Viewing       capabilities within and from outside hospital         Mandatory(ICU)
                                                  utilizing VPN and Citrix
1.6.1                                             One or more clinically active CIS records must
                                                  be able to be viewed entirely by authorized
                                                  users or administrators on remote, non-clinical
                                                  workstations throughout the local area network
                                                  (LAN). Access of CIS records by remote, non-          Mandatory(ICU)
                                                  clinical workstations must be via a browser-
                                                  based application or a special viewing program.


1.6.2                                             All off-site performance monitoring of CIS
                                                  hardware or software must satisfy VA Cyber-
                                                  Security Requirements, the Administrative
                                                  Simplification provisions of the Health Insurance
                                                                                                        Mandatory(ICU)
                                                  Portability and Accountability Act of 1996
                                                  (HIPAA), and the provisions of The Privacy Act
                                                  of 1974 and its Veterans Affairs applications.

1.6.3                                             Upgrades to the CIS server or workstation
                                                  software that are accomplished by the
                                                  manufacturer through remote access must
                                                  satisfy VA Cyber-Security Requirements,
                                                  preserve firewalls, and meet Enterprise
                                                  Architecture Standards and VA security
                                                                                                        Mandatory(ICU)
                                                  guidelines for virus protection. Software or
                                                  hardware upgrades must not disrupt or alter a
                                                  clinically active CIS record. An audit trail of all
                                                  software changes must be maintained. All
                                                  upgrades must be coordinated with COTR.

1.8                        VistA/CPRS             CIS application must not interfere with VA
                           Compatibility          approved programs (including the following)
                                                  • BCMA
                                                  • VISTA/CPRS
                                                  • VISTA Imaging
                                                  • Clinical Note Templates
                                                  • Internet Browser
                                                  • Microsoft Offices Products
                                                  • Java/Active X-Plug Ins
                                                                                                        Mandatory(ICU)
                                                  • SMS
                                                  • McAfee Virus Scan
                                                  • ISS Proventia firewall
                                                  • Sentillion Vergence Locator
                                                  • Analytic Database
                                                  • The CIS client application Microsoft Terminal
                                                  Services or Citrix should be supported for
                                                  remote viewing within the VA Firewall and the
                                                  via One VA VPN.
1.9                        Implementation         Implementation program must be specifically
                                                  designed for VA to leverage system knowledge          Mandatory(ICU)
                                                  and efficiencies




Nat'l Mandatory Elements                                                                                                 2 of 28
                                                                                                                              VISN 6 ICU CIS Requirements



1.10                       Maintenance program   A uniform, multi-year maintenance program
                                                 must be available for all VISNs and must
                                                 include all application upgrades, new versions,
                                                                                                   Mandatory(ICU)
                                                 patches, etc. This program must ensure that all
                                                 VISNs are using the same CIS version.

1.11                       Device Drivers        Device drivers to all VA medical devices for
                                                 patient use in OR, ICU, PACU, etc. must be
                                                 capable of accepting all data, measured and
                                                                                                   Mandatory(ICU)
                                                 calculated. These drivers must be available
                                                 without additional cost to all VISNs.

1.12                       Device Features       Once properly accessed, CIS workstations must
                                                 have the capability to toggle
                                                 (foreground/background continuous
                                                                                                   Mandatory(ICU)
                                                 functionality) between the CIS applications and
                                                 the Computerized Patient Record System
                                                 (CPRS).




Nat'l Mandatory Elements                                                                                            3 of 28
                                                                                                                                         VISN 6 ICU CIS Requirements




2.0        System
           Requirements
           and
           characteristics
2.1                              Interoperability       Must Demonstrate following Requirements Prior
                                                        to Contractual Obligation with VISN
2.1.1                                                   CIS applications in every clinical monitoring
                                                        location [ICU, PACU and OR] must provide
                                                        interoperability capabilities 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
                                                        CIS,                                                  Mandatory(ICU)

                                                        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.

2.2        IT Requirements and   Workstation            Applications must be able to be run on the
           characteristics       Requirements for CIS   typical VA workstation hardware as listed below.
                                 and ARK                 Any requirements 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 CIS and Interface
                                                        Software to operate at an efficient level as          Mandatory(ICU)
                                                        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, (VISN CIO to edit as desired).

3.0        Network
           Requirements
3.1                                                     CIS client application workstation shall be able
                                                        to be run with a standard 100 full duplex
                                                        network connection to the 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
                                                                                                              Mandatory(ICU)
                                                        CIS connection. The above must be clearly
                                                        outlined and included with the Contractor‟s
                                                        response as Attachment D, Exhibit 6. The VA
                                                        shall provide all necessary network hardware to
                                                        meet this connection speed.

3.2                                                      The CIS Contractor shall provide a listing of
                                                        port and protocols used by the CIS system and         Mandatory(ICU)
                                                        include in Attachment D, Exhibit 7.
3.3                                                     The CIS software shall be able to be run on PC
                                                                                                              Mandatory(ICU)
                                                        located on the hospital domain.
3.4                                                     The CIS system shall be able to operate over a
                                                        WAN with a T3 connection. Contractor shall
                                                        ensure that VISN XX will be able to operate
                                                        servers at remote locations for decreased
                                                                                                              Mandatory(ICU)
                                                        hardware maintenance. A diagram of the VISN
                                                        XX WAN is included in this RFP. (See Tab -
                                                        WAN Diagram)




Nat'l Mandatory Elements                                                                                                       4 of 28
                                                                                                                                     VISN 6 ICU CIS Requirements



3.5                                                     The CIS software shall have ability to operate
                                                        off a WAN link with common intra VISN network
                                                                                                          Mandatory(ICU)
                                                        latencies of up to 30 mS and VPN latencies of
                                                        up to 100mS
3.6                                                     Reliable and robust application able to survive
                                                                                                          Mandatory(ICU)
                                                        network and server failures
3.7                                                     Provide plans for CIS production and database
                                                        server redundancies for hospital/VISN/IT region
                                                                                                          Mandatory(ICU)
                                                        including network failures.

4.0        Required VistA    VHA will provide a
           Interface         uniform interface across
                             all VISNs and hospitals
           Requirements      to share information
           (Note: vendor     between VistA and CIS
           must              used for the ICU, ARK,
           demonstrate       PACU and Anesthesia
                             Preop. The interface
           following
                             primarily will use HL7
           requirements      communications as well
           prior to          as VistA Broker Calls
           contractual       (APIs). The vendor side
           obligation with   of 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 –
                             CLIN 003-1)

4.0.1.1                                                 1) CIS device drivers or other electronic
                                                        communication means to all VA medical
                                                        devices for patient use must be capable of        Mandatory(ICU)
                                                        accepting all data, measured and calculated.




Nat'l Mandatory Elements                                                                                                   5 of 28
                                                                                                           VISN 6 ICU CIS Requirements



4.0.1.2                    2) Provide HL7 (or other) interfaces to all VISN
                           XX site physiologic monitoring systems for VISN      Mandatory(ICU)
                           XX including:
4.0.1.2.1                        a) GE                                          Mandatory(ICU)
4.0.1.2.2                        b) Philips                                     Mandatory(ICU)
4.0.1.2.3                        c) Draeger/Siemens                             Mandatory(ICU)
4.0.1.3                    3) Provide connectivity the following VISN XX
                           medical devices for VISN XX, such as (see also       Mandatory(ICU)
                           Attachment F):
4.0.1.3.1                        a) B Braun Infusion Pumps                      Mandatory(ICU)
4.0.1.3.2                        b) Critical Care Ventilators                   Mandatory(ICU)
4.0.1.3.3                        c) Anesthesia Machines                         Mandatory(ICU)
4.0.1.3.4                        d) IABP devices                                Mandatory(ICU)
4.0.1.3.5                        e) Dialysis/CVVH Machines                      Mandatory(ICU)
4.0.1.4                    4) Additional medical devices interfaces may
                           be required as new equipment is identified for
                           interfacing existing equipment/software
                           identified herein for the CIS. These medical
                           device interfaces will be developed and
                           provided at no charge to the VA upon request
                           of the VISN XX COTR. If however, interfaces
                           are required for those excluded from the above
                           and additional charges may apply, the                Mandatory(ICU)
                           Contractor shall provide a written proposal to
                           include a detailed description of the product and
                           estimated pricing structure associated with any
                           additional interface with this proposal as Exhibit
                           9 The above will be reviewed during the
                           evaluation process however costs for the above
                           are not to be included in the final price for this
                           contract.
4.0.1.5                    5) Applications collection data from these
                           medical devices shall run as a service or a
                           daemon and shall not require a user to be            Mandatory(ICU)
                           interactively logged into the computer to collect
                           the data.




Nat'l Mandatory Elements                                                                         6 of 28
                                                                                                                                 VISN 6 ICU CIS Requirements



4.0.2                      b. VistA Interfaces
                           Government
                           Furnished Property

4.0.2.1                                          Overview: The Contractor must provide
                                                 interfaces to solve the problem of electronic
                                                 documentation, continuum of care, advance
                                                 clinical access, and clinical workflow in critical
                                                 care areas. The interfaces will exchange data bi-
                                                                                                      Mandatory(ICU)
                                                 directionally between VistA/CPRS and 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 operate on the VistA systems.
                                                 These interfaces are 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
                                                                                                      Mandatory(ICU)
                                                 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.


4.0.2.3                                          For this particular contract and the products
                                                 being acquired, the VistA-side interfaces have
                                                 been developed by a third party. That
                                                                                                      Mandatory(ICU)
                                                 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 VHA requirements are listed below.
                                                 The VA-side of the VistA interface will be
                                                 provided to the successful Clinical Information
                                                 System (CIS) Contractor for the ICU CIS. The         Mandatory(ICU)
                                                 CIS Contractor will be required to have a VistA
                                                 testing environment, QA staff, and provide
                                                 installation, training and support of the CIS
                                                 interface.




Nat'l Mandatory Elements                                                                                               7 of 28
                                                                                                                                          VISN 6 ICU CIS Requirements



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 vendors using the VA master list
                                                                                                               Mandatory(ICU)
                                                        permitting clinical users access to a CIS using
                                                        only VA passwords.
4.1.2                                                   2. Description:
                                                                                                               Mandatory(ICU)
4.1.2.1                                                 a. Users will sign-on to CIS using their VistA
                                                        access/verify codes in a logon dialog box with
                                                                                                               Mandatory(ICU)
                                                        asterisks (***) displayed for both codes.

4.1.2.2                                                 b. A separate authentication system is not
                                                        maintained in the CIS for standard logons. A
                                                        shadow list may be employed for use only when
                                                        the network or CPRS is down utilizing VA
                                                                                                               Mandatory(ICU)
                                                        security standards. All changes in VA
                                                        access/verify codes must be used immediately
                                                        for subsequent CIS authentications.

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

4.1.2.5                                                 e. The CIS may determine a user‟s user group
                                                        by querying the Vista interface for the user           Mandatory(ICU)
                                                        group(s) that a user is assigned to.
4.1.2.6                                                 f. The Vista interface determines the user group
                                                        using “rules” based upon the user‟s keys, title,
                                                        and/or ASU user class. Each site must also             Mandatory(ICU)
                                                        create keys matching the CIS user group name.

4.1.2.7                                                 g. Rules defining user groups are included with
                                                        this interface and individual VISNs may create         Mandatory(ICU)
                                                        their own as well.
4.1.2.8                                                 h. If the logon is unsuccessful, the user may not
                                                        gain further access to the application. (Logons
                                                                                                               Mandatory(ICU)
                                                        will be limited to a fixed number of failed
                                                        attempts, e.g., <10.)
4.1.2.9                                                 i. A temporary „work around‟ must become
                                                        available to allow users to logon only if network
                                                        access is not available. As soon as the network
                                                                                                               Mandatory(ICU)
                                                        is available—and it is feasible clinically—user
                                                        must logon to the CIS by the standard method.

4.1.2.10                                                j. Electronic Signature data will be sent to CIS to
                                                        allow provider signing in CIS, including notes
                                                                                                               Mandatory(ICU)
                                                        and records signed in CIS prior to sending to
                                                        VistA.




Nat'l Mandatory Elements                                                                                                        8 of 28
                                                                                                                                           VISN 6 ICU CIS Requirements



4.2                        Patient Selection /
                           Registration in 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 send patient specific information to
                                                        the CIS with updates triggered by the CIS and
                                                        VistA as necessary. VistA identity management           Mandatory(ICU)
                                                        procedures are maintained and extended within
                                                        the CIS.

4.2.2                                                   2. Description:
                                                                                                                Mandatory(ICU)
4.2.2.1                                                 a. Patients will be selected from within CIS by
                                                                                                                Mandatory(ICU)
                                                        multiple methods including the following:
4.2.2.1.1                                               i. from a list in CIS, which must be updated
                                                        contemporaneously from ADT messages or
                                                                                                                Mandatory(ICU)
                                                        poling the Surgery Schedule when appropriate,

4.2.2.1.2                                               ii. utilizing a GUI similar to CPRS patient
                                                        selection (e.g., initial + “last 4 SSN”, Teams,         Mandatory(ICU)
                                                        wards),
4.2.2.1.4                                               iv. a „John Doe‟ option permitting use of the CIS
                                                        without first requiring patient registration in VistA   Mandatory(ICU)
                                                        (see section e. below),
4.2.2.2                                                 b. Patient identification information consists of
                                                        multiple identifiers and the CIS patient
                                                        identification process must meet VA standards
                                                        (ENTR888 and ENTR942: vendor
                                                        transactions/messages from or to VistA shall be         Mandatory(ICU)
                                                        capable of including the source identifiers within
                                                        all messages that exchange data with other
                                                        VHA systems.)
4.2.2.3                                                 c. Upon registration of a valid patient in the CIS,
                                                        the patient information will be sent to CIS
                                                        triggered by multiple events including query
                                                        from CIS, ADT message, surgery schedule
                                                        message or patient information update. The
                                                                                                                Mandatory(ICU)
                                                        patient information, to be updated in CIS, will
                                                        include, not limited to, patient identification
                                                        identifiers, patient demographics, Code Status,
                                                        CWAD, bed location, treating specialty, etc..

4.2.2.3.1                                               i. New messages to CIS are sent for updates to
                                                        the patient data stored when MPI updates data
                                                        in VistA. CIS must update its database with the         Mandatory(ICU)
                                                        new data contemporaneously.

4.2.2.3.2                                                ii. CWAD (Clinical Warnings and Advanced
                                                        Directives) will accompany patient
                                                        registration/ADT messages, as well as provide
                                                        a „re-send message‟ trigger when information is
                                                        updated. If Patient Record Flags (Category 1            Mandatory(ICU)
                                                        and 2) exist in VistA, transmit to CIS for display
                                                        including any changes/updates during that
                                                        episode of care.




Nat'l Mandatory Elements                                                                                                         9 of 28
                                                                                                                                  VISN 6 ICU CIS Requirements



4.2.2.3.3                                              iii. For each patient, CIS must accept
                                                      VISN/hospital specific team names, ICU
                                                      locations (e.g., bed names) and treating
                                                                                                          Mandatory(ICU)
                                                      specialty names, (e.g., MICU, SICU, CCU) to
                                                      correctly identify patient locations and clinical
                                                      provider groups/teams.
4.2.3                                                 d. Procedures must be included to allow the
                                                      emergent, manual entry of patient
                                                      demographics entered into the CIS prior to
                                                      Registration through ADT in VistA. Easy             Mandatory(ICU)
                                                      identification and resolution of any differences
                                                      once VistA registration is accomplished must be
                                                      facilitated by CIS.
4.2.4                                                 e. There must be a simple, reliable method to
                                                      retroactively match duplicate identities stored
                                                      within both systems with „John Doe‟ or incorrect
                                                                                                          Mandatory(ICU)
                                                      patient assignments to prevent the creation of
                                                      duplicate patient records in CIS.

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

4.3.1                                                 A) Allergies — Current allergies in VistA are in
                                                      separate messages. A complete allergy set will
                                                      be sent with a CIS query, bed control (AO) or
                                                      surgery scheduling (SR) accompanied by
                                                                                                          Mandatory(ICU)
                                                      pharmacy orders (ORM) based upon actions
                                                      within the CPRS, bed control or surgery
                                                      scheduling system, as well as patient
                                                      registration in CIS.
4.3.2                                                 2.    Purpose: To provide allergy data stored in
                                                                                                          Mandatory(ICU)
                                                      VistA for display in CIS.
4.3.3                                                 3.    Description:
                                                                                                          Mandatory(ICU)
4.3.3.1                                               a.    A read-only set of allergy data is sent in
                                                                                                          Mandatory(ICU)
                                                      CIS for display-only.
4.3.3.2                                               b.    Allergy messages are triggered by event
                                                      changes managed in VistA. (CIS query, ADT,
                                                      surgery schedule, pharmacy orders, patient          Mandatory(ICU)
                                                      registration in CIS, or modifications to allergy
                                                      data)
4.3.3.3                                               c.    Allergy updates made in VISTA must be
                                                      updated automatically and in real-time in the
                                                      CIS. Changes must be displayed in CIS both          Mandatory(ICU)
                                                      as a 'new' or 'critical' data alert and in an
                                                      updating data field.




Nat'l Mandatory Elements                                                                                               10 of 28
                                                                                                                                      VISN 6 ICU CIS Requirements



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 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 CIS
                           at the correct times in
                           graphic and tabular
                           formats.)


4.4.1                                                  A) Lab Results — All verified lab ORM HL7
                                                       messages will be sent to CIS including                 Mandatory(ICU)
                                                       microbiology.
4.4.1.1                                                1.     Purpose: To send hematology,
                                                       microbiology, blood bank and chemistry lab             Mandatory(ICU)
                                                       results to the CIS.
4.4.1.2                                                2. Description:                                        Mandatory(ICU)
4.4.1.3                                                a1.     Hematology and chemistry lab results will
                                                       be sent from VistA Laboratory package to CIS
                                                       for display. No limitations can be placed on
                                                                                                              Mandatory(ICU)
                                                       maximum number of laboratory data (specific
                                                       tests or numbers of test results).

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

4.4.1.5                                                b.   „Out of range‟ and „critical value‟ labels will
                                                       accompany results as appropriate. CIS must
                                                                                                              Mandatory(ICU)
                                                       accept and display these data.

4.4.1.6                                                c.   Results formats will be modified to permit
                                                       CIS to display logical categories (e.g., CBC
                                                                                                              Mandatory(ICU)
                                                       panel) rather than just alphabetical order.

4.4.1.7                                                d.   Query capabilities initiated by CIS will
                                                       mimic CPRS (date range, specific results, etc.)        Mandatory(ICU)

4.4.1.8                                                e. Changes must be displayed in CIS both as
                                                       a 'new' or 'critical' data alert and in an updating    Mandatory(ICU)
                                                       data field.




Nat'l Mandatory Elements                                                                                                   11 of 28
                                                                                                         VISN 6 ICU CIS Requirements



4.4.2                      B) Pharmacy Medication Schedules and
                           Administration — All medications will be sent
                                                                                 Mandatory(ICU)
                           to CIS including include both outpatient and
                           inpatient medications.
4.4.2.1                    1.    Purpose: To send medications schedules
                           and administration to the CIS for display-only.       Mandatory(ICU)

4.4.2.2                    2.     Description:                                   Mandatory(ICU)
4.4.2.3                    a1.     Pharmacy medication schedules,
                                                                                 Mandatory(ICU)
                           outpatient re-fills.
4.4.2.4                    a2.     Inpatient administration events contained
                           in BCMA will be sent contemporaneously to CIS         Mandatory(ICU)
                           for read only use
4.4.2.5                    b.     Verified and cancelled order messages
                                                                                 Mandatory(ICU)
                           will be included.
4.4.2.6                    c.    Queries capabilities initiated by CIS will
                           mimic CPRS (date range, specific results, etc.)       Mandatory(ICU)

4.4.2.7                    d.    All order modifications will be made
                                                                                 Mandatory(ICU)
                           contemporaneously in VistA and CPRS.
4.4.2.8                    e.    VA Formulary will be sent to CIS.               Mandatory(ICU)
4.4.2.9                    f.    Changes must be displayed in CIS both as
                           a 'new' or 'critical' data alert and in an updating   Mandatory(ICU)
                           data field.
4.4.3                      C) Nursing and Dietary Orders — All Nursing
                           and Dietary Orders will be sent to CIS in
                                                                                 Mandatory(ICU)
                           delimited 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 provide treatment schedules in CIS.           Mandatory(ICU)

4.4.3.2                    2. Description:                                       Mandatory(ICU)
4.4.3.3                    a. Nursing and Dietary orders will be sent to CIS
                                                                                 Mandatory(ICU)
                           for read-only use.
4.4.3.4                    b. All order modifications will be made in VistA
                           and contemporaneously displayed in CIS.
                           Changes must be displayed in CIS both as a            Mandatory(ICU)
                           'new' or 'critical' data alert and in an updating
                           data field.
4.4.4                      D) Radiology Orders — All radiology orders
                                                                                 Mandatory(ICU)
                           will be sent to CIS.
4.4.4.1                    1. Purpose: radiology orders will be sent to
                                                                                 Mandatory(ICU)
                           facilitate nursing schedules in CIS.
4.4.4.2                    2. Description:                                       Mandatory(ICU)
4.4.4.3                    a. Radiology orders will be sent to CIS for read-
                                                                                 Mandatory(ICU)
                           only use.
4.4.4.4                    b. All order modifications will be made in VistA
                           and contemporaneously displayed in CIS.
                           Changes must be displayed in CIS both as a            Mandatory(ICU)
                           'new' or 'critical' data alert and in an updating
                           data field.
4.4.5                      E) Vital Signs — Vital signs will be sent to CIS.
                                                                                 Mandatory(ICU)
4.4.5.1                    1. Purpose: A record of the complete patient
                           vital sign information from VISTA (including O2
                                                                                 Mandatory(ICU)
                           saturation and pain scores, as available) will be
                           sent to the CIS..
4.4.5.2                    2. Description:                                       Mandatory(ICU)
4.4.5.3                    a. Vital sign data will be sent to the CIS for use
                                                                                 Mandatory(ICU)
                           by clinicians.
4.4.5.4                    b. Updated data will be sent to the CIS.              Mandatory(ICU)




Nat'l Mandatory Elements                                                                      12 of 28
                                                                                                                                   VISN 6 ICU CIS Requirements



4.4.6                                                 F) Problem List — Current Problem List
                                                                                                           Mandatory(ICU)
                                                      entries will to be sent to CIS.
4.4.6.1                                               1.    Purpose: The Problem List contain
                                                      information on current patient problems that         Mandatory(ICU)
                                                      may be valuable in 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 and modifications to the list.     Mandatory(ICU)

4.4.6.4                                               b. ICD-9 codes will be included.                     Mandatory(ICU)
4.4.7                                                 G) Notification of New Messages — A
                                                      „Notification‟ message will identify all new         Mandatory(ICU)
                                                      messages sent to CIS.
4.4.7.1                                               1.     Purpose: The Notification message will be
                                                      used by the CIS to alert the clinical user of new
                                                      messages received by the CIS. The CIS will
                                                      display the message type in efficient and easily
                                                                                                           Mandatory(ICU)
                                                      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,
                                                      „Notification‟ message is sent also to the CIS
                                                                                                           Mandatory(ICU)
                                                      identifying alerts, new lab values, etc.

4.4.7.4                                               b. The CIS will use the information in the
                                                      Notification message to inform the clinical user     Mandatory(ICU)
                                                      of receipt of new data.
4.4.7.5                                               c. The CIS will display a 'connection interrupted'
                                                      message obvious to the clinical provider within
                                                      5 minutes of a communication interruption (
                                                      VistA, DSS, or network failure) between the CIS
                                                      and VistA.

4.5                        Time Synchronization
                           — The times in the CIS
                           systems must be
                           synchronized with VistA.


4.5.1                                                 1.    Purpose: To have an accurate medical
                                                      record the CIS clocks must be identical to the       Mandatory(ICU)
                                                      VistA time.
4.5.2                                                 2.    Description:
                                                                                                           Mandatory(ICU)
4.5.2                                                 a.    The CIS must receive a timing signal from
                                                      the interface and the synchronize the CIS time       Mandatory(ICU)
                                                      with the VistA time.




Nat'l Mandatory Elements                                                                                                13 of 28
                                                                                                                                   VISN 6 ICU CIS Requirements



4.6                        VistA Imaging — A .pdf
                           image is sent from CIS
                           to VistA Imaging will be
                           associated with a TIU
                           note.

4.6.1                                                 1. Purpose: Since dense data and many data
                                                      types cannot be stored in VistA, the CIS must
                                                                                                           Mandatory(ICU)
                                                      create an image file for permanent, medical
                                                      record storage in VistA.
4.6.2                                                 2. Description:
                                                                                                           Mandatory(ICU)
4.6.2.1                                               a. Images of the ICU flowchart, PACU record,
                                                      and anesthesia record will be created and sent
                                                      to VistA Imaging by the CIS at both pre-
                                                                                                           Mandatory(ICU)
                                                      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 administratively signed. Must be able to
                                                                                                           Mandatory(ICU)
                                                      attach provider signature, when required.

4.6.2.3                                               c. Similar to paper flow sheets and records, the
                                                      images display the initials of the individual who
                                                      entered a particular value. The individual‟s full    Mandatory(ICU)
                                                      name is displayed as a legend on the form.

4.6.2.4                                               d. PDF is the required format.                       Mandatory(ICU)
4.7                        TIU (Progress Note) —
                           A progress note is
                           created in the CIS and
                           sent to VistA.
4.7.1                                                 1. Purpose: A TIU note signed by the clinician
                                                      is created in CIS and placed in CPRS Progress        Mandatory(ICU)
                                                      Notes.
4.7.2                                                 2. Description:
                                                                                                           Mandatory(ICU)
4.7.2.1                                               a. Progress notes created within CIS will be
                                                      exported to CPRS for permanent display and           Mandatory(ICU)
                                                      storage in VistA Progress Notes.
4.7.2.2                                               b. The note may be reviewed, edited and
                                                      electronically signed in VistA. It may also be
                                                      signed in the CIS or administratively signed in      Mandatory(ICU)
                                                      VistA. The capability for both approaches are
                                                      required in the CIS.
4.7.2.3                                               c. All elements in the progress note are
                                                                                                           Mandatory(ICU)
                                                      configurable by the site.
4.7.2.4                                               d. Electronic signatures applied in CIS along
                                                      with the signed progress note will be transmitted    Mandatory(ICU)
                                                      to VistA.
4.7.2.5                                               e. Electronic signature information will be
                                                      accessed/validated in VistA at the time of           Mandatory(ICU)
                                                      signing into CIS.




Nat'l Mandatory Elements                                                                                                14 of 28
                                                                                                                                       VISN 6 ICU CIS Requirements



5.0        Additional CIS                              THE FOLLOWING CLINICAL ASSESSMENT
           Clinical                                    APPLICATIONS REQUIRE A RESPONSE AS
           Assessment                                  TO WHETHER YOUR SYSTEM HAS THE
                                                       CAPACITY TO ACCOMPLISH THE
           Capabilities
                                                       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 every page of the electronic               Mandatory(ICU)
                                                       display and record images.
5.1                         Document body
                                                                                                               Mandatory(ICU)
                            system assessments
5.1.1                                                  The capability to document body system
                                                       assessments sufficient to provide the Unit with a
                                                       detailed head-to-toe assessment that is
                                                                                                               Mandatory(ICU)
                                                       configurable to each Unit, level of care, facility
                                                       and groups of patients e.g. liver transplant or
                                                       open heart.
5.1.2                                                  Transfer documentation between units/services
                                                       must include required elements for each unit            Mandatory(ICU)
                                                       (e.g., SOAP notes).
5.1.3                                                  The CIS must include severity scales. Severity
                                                       scales must be calculated automatically (with
                                                       mandatory manual data elements, as required),
                                                       such as Apache II, III and IV, APS, Braden,
                                                                                                               Mandatory(ICU)
                                                       Aldrete, Glascow coma scale, Morse fall scale,
                                                       nutrition scoring, etc. as well as locally created
                                                       scores.

5.2                         Manage calculations
                            and calculated data                                                                Mandatory(ICU)

5.2.1                                                  The ability to accept calculated values from
                                                       other devices (including data devices such as           Mandatory(ICU)
                                                       monitors etc.).
5.2.2                                                  The ability to perform manual and automatic
                                                                                                               Mandatory(ICU)
                                                       clinical calculations
5.3                         Enter data and
                            conduct fluid balance
                                                                                                               Mandatory(ICU)
                            management

5.3.1                                                  The ability of clinicians on different shifts to
                                                       enter data into a system that is capable of
                                                       distinguishing fluids (blood, drips, IV fluids, etc.)   Mandatory(ICU)
                                                       and manage continuous fluid balance
                                                       calculations inclusive of unit stay.
5.3.2                                                  The ability to identify net negative I/O .
                                                                                                               Mandatory(ICU)
5.3.3                                                  The ability to document all blood product
                                                                                                               Mandatory(ICU)
                                                       administration as individual components.
5.4                         Intuitive user interface
                                                                                                               Mandatory(ICU)
5.4.1                                                  The user inter face should be easy and implicit:
                                                       colors, icons, graphs, pick lists, freeform text,
                                                       notes, forms, point and click, drop and drag,
                                                                                                               Mandatory(ICU)
                                                       copy and paste and other normalized Word-
                                                       type capabilities are critical to reducing errors.

5.4.2                                                  The user interface must be 508 compliant,
                                                                                                               Mandatory(ICU)
                                                       where applicable.




Nat'l Mandatory Elements                                                                                                    15 of 28
                                                                                                                                VISN 6 ICU CIS Requirements



5.5                        Charting Capabilities                                                        Mandatory(ICU)
5.5.1                                              Step-down units: configurable fields and views
                                                                                                        Mandatory(ICU)
                                                   according to unit.
5.5.2                                              Ability to 'force' selection of entries from pick-
                                                                                                        Mandatory(ICU)
                                                   lists to minimize free-text
5.5.3                                              Ability to add structured notes for procedures,
                                                   H&P, patient problems (i.e., to facilitate SOAP      Mandatory(ICU)
                                                   or PIE charting) etc.
5.5.4                                              A method must be in place that will allow the
                                                   user to annotate artifactual data, with an audit
                                                   trail of corrected data maintained. If the CIS
                                                                                                        Mandatory(ICU)
                                                   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(ICU)
5.5.6                                              Create, setup and manage administrations of
                                                                                                        Mandatory(ICU)
                                                   infusions and complex drips
5.5.7                                              Ability to auto calculate I‟s and O‟s (data
                                                   displayed by tables, variable time periods,
                                                   graphically, separated into colloid, crystalloid,    Mandatory(ICU)
                                                   blood // urine, NG, chest tube, etc.)

5.5.8                                              Display tabular and graphical values (including
                                                   from CPRS with vital signs, laboratory values,
                                                                                                        Mandatory(ICU)
                                                   and other data)—all on the same timeline

5.5.9                                              The ability to display I/O balance (preferably
                                                   graphically) over a user selected time period.       Mandatory(ICU)

5.5.10                                             Ability to easily configure the flowchart to the
                                                   individual patient, i.e., add or subtract rows as    Mandatory(ICU)
                                                   patient condition changes
5.5.11                                             Ability to document JCAHO patient safety
                                                   standards such as critical alarm settings,           Mandatory(ICU)
                                                   restraints, patient education, etc.




Nat'l Mandatory Elements                                                                                             16 of 28
                                                                                                                                                           CIS Requirements
                                                                                                                                                           October 29, 2008

    Ref.             Category                      Sub-category                                                      Elements
1.13        National VISN System Workstation Provider/Patient Devices      CIS workstations shall operate with non-proprietary hardware, including central processing
            Requirements                                                   units (CPUs), keyboards, pointing devices (e.g. mice, light pens, track balls, or touch
                                                                           screens), and computer monitors. This does not include patient physiologic monitors

1.13.1                                                                     CIS devices shall include input capabilities from Bar-Code readers.
1.13.2                                                                     CIS devices shall include input capabilities from swipe-card readers. This includes VA
                                                                           SmartCard identification badges.
1.13.3                                                                     CIS devices shall include input capabilities from radio frequency identification (RFID) tags
                                                                           and/or biometric (fingerprint) identifiers where such technology is available.
3.0         System Components

3.1                                Hardware                                If you recommend workstations, they shall include features that make the workstations more
                                                                           ergonomic and flexible for staff use (e.g., space requirements, flat screen monitor,
                                                                           workstation chair, keyboard, and monitor.).
3.1.1                                                                      Workstations shall be portable with minimal steps required in disconnecting a workstation
                                                                           from one bed and reconnecting and configuring it at another bed.
3.2                                The CIS and Associated Networks
3.2.1                                                                      Describe typical hardware utilized for your systems—although it is expected all hardware will
                                                                           be purchased by VA.
3.2.2                                                                      Identify networking hardware components that you will expect each hospital to provide for
                                                                           your system implementation
3.2.3                                                                      Identify any hardware and software/network expertise you would expect the VA to provide for
                                                                           your system implementation
3.3                                CIS Application Suite
3.3.1                                                                      If your CIS consists of a suite of applications or software options, describe each.
3.3.2                                                                      If applicable, please discuss the applications most commonly purchased by other VA's.

3.3.3                                                                      If applicable, are there applications that other VA‟s do not commonly purchase? Describe.

3.4                                CIS Database
3.4.1                                                                      Please describe your CIS database including capabilities, limitations, type, and conformation
                                                                           of database.
3.4.2                                                                      What physiologic/device data are stored in your database? At what maximum frequency?
                                                                           Are the data stored permanently? What is the maximum frequency of data storage in your
                                                                           permanent database? Are all dense data available for queries?
3.4.3                                                                      All data from the prior CIS version shall remain compatible and incorporated into new
                                                                           software versions.
3.4.4                                                                      Will you provide warranties against obsolescence of data in your database?
3.4.5                                                                      Do you have pre-defined fields that are populated in your database? Describe them.
3.4.6                                                                      The CAC and/or the vendor shall have the ability to add calculated variables fields to the
                                                                           database.
3.4.7                                                                      The database shall have the ability to have new fields added to the database once CIS is in
                                                                           clinical use.
3.4.8                                                                      The VISN shall have control on database and templates.
3.4.9                                                                      How does your CIS control variable names? Can all fields have alias or user-defined names?




Desirable Elements                                                      17 of 28
                                                                                                                              CIS Requirements
                                                                                                                              October 29, 2008

3.4.10                                        The 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. Can ? List all fields/entry locations that
                                              have no control capabilities.
3.4.11                                        What languages may be used to generate reports from your CIS database? What level of
                                              expertise is required? Do you have „canned‟ reports? Can the reports be constructed by the
                                              CAC? Can the results of reports be displayed graphically? Describe in detail the complexity of
                                              available graphics functions. Please provide examples of both reports and the processes
                                              required to construct new reports. How are new queries created? Who does it? List all that
                                              you have created. Can these be modified? Please describe the process. Cost/query? Can
                                              you include real-time variables in queries? Can you create new variables by computation?
                                              Can you do time-series analyses? (e.g., heart rate episodes)

3.4.12                                        The database shall have the ability to add data from other sources (e.g., VistA) and to
                                              include such data in queries
3.4.13                                        Please include a list of users (contacts and phone numbers) who are significantly utilizing the
                                              report and research capabilities of their CIS.
3.4.15                                        The system shall have multiple options for backing-up CIS data. Describe in detail.
3.4.16                                        Describe your options for archiving your CIS data for later data analyses. Include data
                                              density, granularity and storage requirement size relationships.
3.5                  CIS IT Capabilities

3.5.1                                         The system shall maintain the same database(s) in multiple areas (ICU, Step-down, etc.)

3.5.3                                         How many CIS workstations can your system accommodate in one care area? How many
                                              areas?
3.5.4                                         How many total CIS workstations can your system accommodate per server?
3.5.5                                         CIS workstations outside of the units shall connect to the CIS and associated networks (i.e.,
                                              clinician offices, homes etc.).
3.5.8                                         Can application software (Patient and Remote) be pushed out to PC or have to be loaded
                                              from CD?)
3.5.9                                         Specify the space required for your servers and phone closet racks. Include specifications for
                                              any environmental and utility requirements.
3.5.10                                        Describe the applicable standards and protocols for your CIS and associated network,
                                              including data transfer rates.
3.5.11                                        CIS workstation and networks shall allow Win 2000 Professional, or XP applications (GUI
                                              CPRS, BCMA, Clinical Note Templates, VistA Imaging, Stentor and Web 1000 Radiology
                                              packages, Internet Explorer, Java/Active-X Plug-Ins, etc.) to run simultaneously on the CIS
                                              bedside workstations.
3.5.12                                        Are your servers Windows 2003? Workstations, XP? Other?
3.5.13                                        Please indicate approximate range of data traffic levels (based on predictions of normal client
                                              loads) on the CIS and associated networks.
3.5.14                                        Specify backup systems on the file servers.
3.5.15                                        Specify backup media provided with the system. Can the system be back-up to a network
                                              attached storage system (NAS) offsite?
3.5.16                                        List any requirements for the hospital network including drops per bed.




Desirable Elements                         18 of 28
                                                                                                                                                                     CIS Requirements
                                                                                                                                                                     October 29, 2008

3.5.17                                                                                Please indicate approximate range of data traffic levels (based on predictions of normal client
                                                                                      loads) on the hospital network.
3.5.18                                                                                Describe how the time is synchronized throughout the CIS and associated systems, including
                                                                                      clinical monitors?
3.5.19                                                                                Describe your requirements for IP addresses including total number and number of fixed
                                                                                      addresses.
3.5.20                                                                                Describe possible CIS and associated networks and/or server failures. What would and
                                                                                      would not be affected by those failures?
3.5.21                                                                                CIS client application workstation shall run with a standard 100 full duplex network connection
                                                                                      to the CIS server.
3.5.22                                                                                The CIS Contractor shall provide a listing of port and protocols used by the CIS system and
                                                                                      include in Exhibit 7.
3.5.23                                                                                Provide plans for CIS production and database server redundancies for hospital/VISN/IT
                                                                                      region including network failures.
3.5.24                                                                                How are network failures (including performance degradation) identified by your system?
                                                                                      How does your CIS notify the system manager of failures? What does your CIS workstation
                                                                                      display when a network failure occurs? How does your system recover from a power (and
                                                                                      network) loss? Are data lost? Under what conditions?
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          VistA Interfaces   Patient Selection / Registration in 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.
4.2.2.1.5                                                                             v. CCOW — when elected at VISN level.
4.3                             Patient Status Information — Code Status
                                information is sent with initial registration of
                                patient in CIS and with all updates to Status
                                content.
4.3.4                                                                                 B) Code Status — The CMS and AMA approved ICD, CPT and HCPCS codes are
                                                                                      contained within the VistA system for use by the staff for the documentation of patient records.

4.3.4.1                                                                               1.      Purpose: To provide code status stored in VistA for display in CIS.

4.3.4.2                                                                               2.      Description:
4.3.4.2..1                                                                            a.      A read-only description of „code status‟ is sent to CIS for display.

4.3.4.2.2                                                                             b.   Messages triggered by event changes managed in VistA. (ADT, surgery schedule,
                                                                                      pharmacy orders, patient registration in CIS, or modifications to code status data)

4.3.4.2.3                                                                             c.      All updates made in VISTA must be updated automatically and in real-time in the CIS.




Desirable Elements                                                                 19 of 28
                                                                                                                                                                         CIS Requirements
                                                                                                                                                                         October 29, 2008

5.4         Additional CIS Clinical Intuitive user interface                          THE FOLLOWING CLINICAL ASSESSMENT APPLICATIONS REQUIRE A RESPONSE AS
            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 CIS shall:
5.5.12                                                                                Store, display and extract monitor/device data permanently at rates of 1 minute or less

5.5.13                                                                                Simultaneously capture, store and export both high resolution data (<=1 min in ICU and
                                                                                      <=30s in ARK) as well as 'validated' data.
5.5.14                                                                                Have the ability to view flowsheet “rolled up” by Q4h, Q8h, Q12h, Q24h, etc.
5.5.15                                                                                Provide flowsheet viewing and documentation at exact time (down to the minute)
5.5.16                                                                                Display and store waveforms from patient monitors
5.5.17                                                                                Have 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                                                                                Have the ability to view various sections on the screen simultaneously, e.g.; vital sign,
                                                                                      vasoactive drips and I & O all at once.
5.5.19                                                                                Describe Printout capabilities and options
5.5.20                                                                                Allow for Progress Note creation (auto entries, selections of entries during creation, multiple
                                                                                      types of notes, etc.) in CIS to be sent to VistA
5.5.21                                                                                Allow two or more users to chart on the same patient in the same time period.
5.5.22                                                                                Restrict ability to leave (or send to VistA) a form until required fields are completed
5.5.23                                                                                Store, display and extract monitor/device data permanently at rates of 1 minute or less

5.6                                  Desirable CIS Clinical Assessment Capabilities THE FOLLOWING CLINICAL ASSESSMENT APPLICATIONS REQUIRE A RESPONSE AS
                                                                                    TO WHETHER YOUR SYSTEM HAS THE CAPACITY TO ACCOMPLISH THE
                                                                                    DESCRIBED ACTION. Describe in detail.
5.1                                  Document body system assessments               The CIS shall:
5.1.4                                                                               Display and store waveforms from patient monitors
5.1.5                                                                               Allow formats to be controllable at the VISN level and applicable at all hospitals
5.2                                  Manage calculations and calculated data
5.2.1                                                                                 Plot all clinical variables, included calculated variables.
5.6                                  Accept/exchange multiple biomedical device
                                     data, including all calculated data
5.6.1                                                                                 Allow all medical device outputs to be captured and recorded in CIS, e.g. IV pump changes
                                                                                      should automatically be reflected in the I&O and MAR.
5.6.2                                                                                 Accept calculated data should include the ability to „pull‟ data from all devices affecting the
                                                                                      patient, including (after the fact) emergency data.
5.7                                  Enter, access, view, monitor and record all
                                     CIS clinical and administrative data
5.7.1                                                                                 Allow a data trail of patient critical issues should be editable, verifiable, and archived and that
                                                                                      this capability should include hemodynamics and pain.
5.7.2                                                                                 Provide a read-only capability after a fixed period of time (ranging from several hours after a
                                                                                      shift ends, up to 24 hours—this would allow a back charting capability.
5.7.3                                                                                 Import digital images of waveforms, etc.




Desirable Elements                                                                 20 of 28
                                                                                                                                                     CIS Requirements
                                                                                                                                                     October 29, 2008

5.8                  Describe the abilities of the system to Create,
                     select and score assessment criteria against
                     trigger various criteria
5.8.1                                                                  Provide triggers that include BCMA medication delivery data, Lab data, Vitals data, I&O data
                                                                       etc.; and other standard scoring systems like CIWA, MASS, Ramsey, etc.
5.8.2                                                                  Alert date driven reminders
5.9                  Describe the ability of the system to
                     Create/modify and monitor patient care
                     protocols and reminders for clinical
                     management
5.9.1                                                                  Have 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 CIS with alert date driven
                                                                       reminders (when to change IV sites, etc.)
5.9.4                                                                  Update and display patient care and disease management protocols
5.9.5                                                                  Have Configurable ALERTS (e.g. Ventilator Days > #; Aspiration precautions; Restraint
                                                                       checks; LOS for multidisciplinary conferences)
5.9.6                                                                  Operate in sync with VistA time protocols
5.9.7                                                                  Synchronize CIS with critical CPRS alerts
5.10                 Export/import configuration elements of an
                     application to same vendor application

5.10.1                                                                 Make database modifications, which can then be propagated to other hospitals.
5.10.2                                                                 Allow 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.).
5.12                 Use established and customizable procedure,
                     diagnosis codes
5.12.1                                                                 Track ICD-9 and procedure codes from patient taxonomies in VistA e.g., mechanical
                                                                       ventilation, dialysis
5.13                 VISN level data base control
5.13.1                                                                 Be reconfigurable to Require to permit VISN wide management database and clinical
                                                                       management, monitoring and education
5.14                 Patient data summaries
5.14.1                                                                 Allow Multi-patient (rounds) summaries to be customizable for both nurses and physicians
                                                                       and be able to print copies.
5.15                 National and individual hospitals/VISNs
                     quality improvement processes




Desirable Elements                                                 21 of 28
                                                                                                                                                               CIS Requirements
                                                                                                                                                               October 29, 2008

5.15.1                                                                   Establish national data standardization and monitoring board to define national level
                                                                         mandatory data elements, solicit and create best practices and pathways etc. would allow
                                                                         hospitals to define specific data objects and create individualized patient care reports, while
                                                                         maintaining enterprise wide standards.
5.16                 Unlimited configuration abilities of families,
                     rows, columns
5.16.1                                                                   Access descriptors, pick list length, clinical pathways, flow sheets, number of forms, and
                                                                         change font size, color, backgrounds, size etc. should be user defined.
5.17                 Simultaneous user input
5.17.1                                                                   Allow Multiple users (each identifiable to others on-line) to chart on the same patient at the
                                                                         same time.
5.18                 Remote view capability both within and
                     without the hospital
5.18.1                                                                   Allow users to remotely view and incorporate the smart alarms while charting within the site
                                                                         remotely (from any PC) coupled with the capability to maximize or minimize CIS screen and
                                                                         allow simultaneous other applications
5.19                 Conduct analysis and decision support for
                     care providers
5.19.1                                                                   Provide for decision support from all data. Multiple data points from a robust decision engine.

5.20                 Describe the ability of your system to meet the
                     following features shown in 5b.28.5-34

5.20.1                                                                   Allow for verification/data input signature capability.
5.20.2                                                                    “restore” previous charting data if patient inadvertently discharged from CIS
5.20.3                                                                   Provide optional auto charting and Manual verification of data before storage
5.20.4                                                                   “default” previously charted values into next charting cell for acceptance or manually change.

5.20.5                                                                   View minimum (preferable 24) hours in a single page view, without having to scroll side to
                                                                         side , top to bottom (Computer screen size requirements)
5.20.6                                                                   Build flow sheets within the master sheet i.e. Skin care, epidural, PCA flow sheets.
5.20.7                                                                   Have data represented in graphical form which would include line graphs and bar graphs:
                                                                         graphs of at least 6 variables in multiple colors using left and right sided scales

5.20.8                                                                   Provide for graphs to be defined on fly with selectable variables and timeline.
5.20.9                                                                   Select multiple colors for flow sheets and graphs
5.20.10                                                                  Edit entries until end of shift and final signature, yet still be visible for viewing during the shift

5.20.11                                                                  Control location of added rows--by sys. manager.
5.20.12                                                                  Group rows in logical subgroups (ABGs, CBC, etc)
5.20.13                                                                  Allow the user to collapse rows with no data in the viewable time range
5.20.14                                                                  Allow user to select groups of charting rows as a family for standards of care i.e. Ventilator
                                                                         family, post open heart family, insulin drip family, VAP family, etc.
5.20.15.                                                                 Allow two or more nurses to chart on the same patient in the same time period for double
                                                                         checking of drip concentrations, insulin dosing, break coverage, and patients needing 2:1
                                                                         coverage




Desirable Elements                                                    22 of 28
                                                                                                                                                     CIS Requirements
                                                                                                                                                     October 29, 2008

5.20.16                                                           Indicate by color change individual tabular values that are out of range. (VA lab ranges must
                                                                  be utilized.)
5.20.17                                                           Allow user to highlight cells requiring input, i.e. if the check is for every two hours, then every
                                                                  two hours that cell is highlighted.
5.20.18                                                           Identify primary nurse and print out on the census form
5.20.19                                                           Allow all IV fluids to be entered and tracked in the CIS.
5.20.20                                                           Allow for IV drug infusions to be entered and tracked in the CIS.
5.20.21                                                           Allow outputs to be entered and tracked in the CIS.
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
5.21.1                                                            Allow for the user to make nursing assignments
5.21.2                                                            Manage all provider assignments.
5.21.3                                                            Track nurse and other provider assignments that change each shift and also temporarily.

5.21.4                                                            Display general demographic information of patients in a log format.
5.21.5                                                            Display patient information at each CIS bedside workstation.
5.21.6                                                            Allow any patient to be viewed from a single CIS bedside workstation.
5.21.7                                                            What are some mechanisms within CIS to alert the care provider that they are or are not
                                                                  charting the patient who is closest to that workstation?
5.21.8                                                            Allow for verification of information, including pre-configured components and CAC-designed
                                                                  components.
5.21.9                                                            Allow for automatically populated fields to be configurable when nurse verification is provided.

5.21.10                                                           Manage provider verification of different flowsheet components (e.g., nursing and RT)?
5.21.11                                                           Allow users to enter free text into a flowsheet cell
5.21.12                                                           Include an ECG strip.
5.21.13                                                           Provide arrhythmia event information and ECG trending information (ST and PVCs).
5.21.14                                                           The user shall be able to view actual waveforms on the CIS workstations.
5.21.15                                                           How does your CIS handle an 'event'? (E.g. for cardiac arrest 'events' can ECG strips,
                                                                  treatments, and flowsheet information be associated together?)
5.21.16                                                           Is your CIS managing central station ECG strips in other facilities?
5.21.17                                                           Help screens shall be configurable locally?
5.21.18                                                           Please provide a list of users (contacts and phone numbers) who are using your method for
                                                                  managing ECG strips.
5.21.19                                                           CIS shall be capable of indexing and interfacing, bidirectionally, with any of the currently
                                                                  available (MUSE etc.) 12-lead EKG acquisition systems. Orders for the acquisition and
                                                                  transfer of such EKGs shall be able to be initiated within the CIS.
5.22                 Clinical Applications Coordinator (CAC)
5.22.1                                                            Please describe your recommendations for local support for both clinical and technical
                                                                  functions. Include necessary prior experiences, clinical and technical capabilities, and
                                                                  hours/week required during both initial and maintenance periods.
5.22.2                                                            What background should a CAC have?




Desirable Elements                                             23 of 28
                                                                                                                                               CIS Requirements
                                                                                                                                               October 29, 2008

5.22.3                                                          Describe/list what clinical components (calculated cells, views, variables, forms, tables,
                                                                variables, etc.) the CAC 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? Can you allow us to
                                                                review it now?
5.22.4                                                          Describe/list the clinical components that cannot be designed by the CAC. Provide a list of
                                                                components designed by you for a typical installation.
5.22.5                                                          Provide examples of locally designed clinical components. Include all steps necessary for
                                                                creation—use screen captures, if useful.
5.22.6                                                          Can CIS sheets/tables designed by other CAC's be used and edited for use, rather than
                                                                starting with blank sheets?
5.22.7                                                          The CIS shall provide pre-configured, clinical components with the installation. List and
                                                                describe them and are they specific to the VA?
5.22.8                                                          Using CIS pre-designed sheets/tables, what is the estimated interval from purchase to 'go-
                                                                live'? How many months typically are required by the CAC in 'set-up' work?
5.22.9                                                          What is the effective learning time before a CAC can start designing sheets?
5.22.10                                                         What training is provided/recommended for the CAC and/or technical support personnel,
                                                                including course content, duration of classes, and location of classes?
5.22.11                                                         What will you provide for clinical support on the go-live dates? How long will you provide this
                                                                support? Please describe your follow-up training programs.
5.22.12                                                         Describe methods and costs for obtaining on-going support (phone, field personnel, etc.).

5.22.13                                                         Provide a list of CACs (contacts and phone numbers) able to attest to the quality of your
                                                                support services and your CIS.
5.22.14                                                         Vendor shall establish CIS user groups.
5.22.15                                                         Are there VA user groups for your CIS product (numbers of participants, meetings, purposes,
                                                                etc.)?
5.22.16                                                         Vendor shall provide and maintain websites for these groups? Other user group contact
                                                                individuals?
5.22.17                                                         Please describe the top five, most recent recommended changes or augmentations to your
                                                                CIS program obtained from your user groups.
5.23                 Vital Signs/Medical Device Interfaces
5.23.1                                                          List all monitors/models from which your CIS will automatically import data. How do you
                                                                synchronize time between the monitors and your CIS? How are these systems connected to
                                                                the CIS, i.e. Serial, Networked, etc..?
5.23.2                                                          For each monitor above, list all parameters imported, including calculated variables (e.g.,
                                                                SVR, CI, etc.).
5.23.3                                                          Describe how monitor data are stored and displayed in your CIS. Contrast cell vs. graphing
                                                                displays. Can the CIS store data at a higher density than is displayed? What is the maximum
                                                                rate of data storage and how do large amounts of stored data affect the displays? How
                                                                configurable is the storage granularity? Can all stored data be always retrieved? Include
                                                                screen shots to illustrate.
5.23.4                                                          How can the rate of data storage in CIS be changed? Can the CIS data storage rates be
                                                                driven automatically by events/alarms, nurse options, or other? Please describe.
5.23.5                                                          Describe how monitor data are verified ('accepted') by the nurse or RT in CIS. Include screen
                                                                shots of the procedure.
5.23.6                                                          Are all your graphs on the same timeline as the cells?
5.23.7                                                          Do you have a 'continuous loop', high-density data storage system to recover prior data? How
                                                                long is the loop and what limitations are placed on the stored data?



Desirable Elements                                           24 of 28
                                                                                                                                                  CIS Requirements
                                                                                                                                                  October 29, 2008

5.23.8                                                             List the ventilators for which you have interfaces. What parameters and variables are
                                                                   imported by your CIS? Do all devices (e.g., ventilators, pumps) have to be the same model
                                                                   throughout the CCU? Please include screen shots of graphed variables. How are these
                                                                   systems connected to the CIS, i.e. .Serial, Networked, etc..?
5.23.9                                                             Do you interface with infusion pumps? List the manufacturers. . If so, how are these systems
                                                                   connected to the CIS, i.e. Serial, Networked, etc..?
5.23.10                                                            List any other devices, including cardiac telemetry, for which you currently have interfaces.

5.23.11                                                            CIS will interface with any existent cardiac telemetry systems including data flow and capture
                                                                   capacities.
5.24                 Remote Capabilities and ―electronic ICU‖
                     capabilities
5.24.1                                                             CIS will upload into your CIS patient monitored data collected while the patient is temporarily
                                                                   outside the CCU (e.g. during transport or while in the OR or radiology), including transport to
                                                                   a remote procedure, and n return download the information from the transport monitor into the
                                                                   CIS system to update the CIS patient chart.
5.24.2                                                             Discuss alternatives, besides using a monitoring network, for remote monitoring using your
                                                                   CIS in a procedure area.
5.24.3                                                             How does the CIS support remote access for acceptable response times?
5.24.4                                                             CIS shall provide a remote 'view' of the CIS application from any XP or Windows 2000
                                                                   workstation inside the hospital's firewall and outside the VA firewall and describe the
                                                                   techniques: VPN? Citrix?
5.24.5                                                             Describe your method and necessary software/hardware.
5.24.6                                                             List all functions/views not available in the remote 'view'. Can the software be configured to
                                                                   view multiple patients monitoring on a single screen shot? How many simultaneous patients?
                                                                   Can this be done concurrently, using multiple monitors for all ICU beds? How configurable is
                                                                   this capacity?
5.24.7                                                             How many simultaneous users can be supported? And what equipment is required for every
                                                                   10 users?
5.24.8                                                             Are any “smart alarms/alerts” existent within your CIS? Can these be monitored and acted
                                                                   upon remotely? Can the alarm/alert levels/thresholds be modified by the user? (“Smart
                                                                   alarms/alerts” meaning that multiple parameters are monitored i.e. Lab values, ECG, CO2,
                                                                   SpO2, BP, etc… alarm at specific user definable levels). Can these alarms be configured to
                                                                   interact independently or by predefined algorithm?
5.24.9                                                             CIS shall have remote visual viewing of patient and patient locale. CIS shall allow for
                                                                   documented two way audio/visual communication from the remote site to the clinical point-of-
                                                                   care site.
5.24.10                                                            CIS shall support remote viewing of multiple CCU patient parameters and “smart
                                                                   alerts/alarms” concurrently including a description of the viewing configurations.
5.24.11                                                            What level of remote access support do you provide? Describe. How is this connectivity
                                                                   achieved, modem? VPN? If you are using a VPN are you currently approved to use a site-to-
                                                                   site connection through the One-VA VPN?
5.25                 Maintenance and Warranty
5.25.1                                                             What is the warranty period for your CIS program? Will warranty (maintenance) period begin
                                                                   with final hospital acceptance?
5.25.2                                                             What is covered under this warranty period? What is provided on-site or by replacement?




Desirable Elements                                              25 of 28
                                                                                                     CIS Requirements
                                                                                                     October 29, 2008

5.253                   How long are software upgrades or enhancements provided free of charge? Do you have a
                        non-obsolescence program? How are sites notified of upgrades?
5.25.4                  Please describe your available CIS service contracts options and the cost for each option.

5.25.5                  What is the warranty period for your CIS workstation hardware?
5.25.6                  Does your system allow anti-virus software be loaded on the system and be actively
                        updating? How are the Microsoft security patches handled?




Desirable Elements   26 of 28
                                                                                                  CIS Requirements
                                                                                                  October 29, 2008
Configuration                    Typical               Laptop/Notebook                  Premium
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 21” LCD
LAN interface           10/100/1000 remote          10/100/1000 remote          10/100/1000 remote
                        wake-on-LAN Ethernet        wake-on-LAN Ethernet        wake-on-LAN Ethernet
                        interface, IPV6 ready       interface card or           interface, IPV6 ready
                                                    docking station, IPV6
                                                    ready

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

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

Modem                   Not authorized in most      Wireless 802.11G/B          Not authorized in most
                        cases                       modem                       cases
Smart Card Reader       Compliant with PC/SC        Compliant with PC/SC        Compliant with PC/SC
                        specifications and ISO      specifications and ISO      specifications and ISO
                        7816 Smart Card             7816 Smart Card             7816 Smart Card
                        Standards; must be on       Standards; must be on       Standards; must be on
                        Windows Hardware            Windows Hardware            Windows Hardware
                        Compatibility List (HCL).   Compatibility List (HCL).   Compatibility List (HCL).
                        May be internal or          Laptop external only.       May be internal or
                        external.                                               external.

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




Hardware Requirements                               27 of 28
                                                                                                   CIS Requirements
                                                                                                   October 29, 2008


                       CIS Data Extraction Requirements
Extracts from 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 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 CIS:
         o The name of the variable (observation) as listed in the 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 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 CIS).
      The extract exports data from the primary 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.
      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
     resonable 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.



Data Extraction                                              28 of 28

								
To top