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VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
1.0 National VISN
System
Requirements
1.1 VISN-Centric National Must Demonstrate following Requirements Prior to Mandatory Mandatory
Database Contractual Obligation with VISN (ICU) (PACU)
Implementation
1.1.1 The database definitions must be identical within all Mandatory Mandatory
hospitals across the VISN. All database and template (ICU) (PACU)
modifications may be entered only once and propagated
as coordinated within the VISN to all facilities. Individual
hospital databases must have the ability to prevent local
modifications.
1.1.2 Vendors must provide a mechanism whereby VISN or Mandatory Mandatory
nationally-directed changes in the database and/or user (ICU) (PACU)
templates can be pushed out to all facilities throughout
the VISN level. A mechanism(s) must be provided to
prevent changes to flowsheet template and database
elements that might be mandated by the VISN or VA
nationally for purposes of standardization.
1.1.3 The ability to create new database elements, controlled at Mandatory Mandatory
the VISN level, must be maintained. Note: this must not (ICU) (PACU)
prevent the ability to assign informational lines (e.g.,
specific templates or assessments), unique for the
management of a specific patient, for use at the individual
facility level and to be included in the patient‘s permanent
medical record.
1.2 Security and Reliability Systems must meet all VA security requirements as well Mandatory Mandatory
as ensure data against system failures (disaster recovery). (ICU) (PACU)
1.2.1 Reliable and robust application able to survive network Mandatory Mandatory
and server failures without loss of data or of real-time data (ICU) (PACU)
display.
Nat'l Mandatory Elements 1 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
1.2.2 Provide plans to ensure ICU-CIS production and database Mandatory Mandatory
server redundancies for hospital/VISN including network (ICU) (PACU)
failures.
1.2.3 Systems must have a method for ensuring the tracking of
user input (audit trails).
1.3 Data Extracts Must Demonstrate following Requirements Prior to Mandatory Mandatory
Contractual Obligation with VISN (ICU) (PACU)
1.3.1 A data extraction system for ALL clinical and Mandatory Mandatory
administrative data in the ICU-CIS database must be (ICU) (PACU)
capable of creating data extracts at least every 4 hours
without degrading performance of ICU-CIS. (CLIN 003-
3—See "Data Extraction" Tab on this spreadsheet for
extract requirements.)
1.3.2 The files must be in XML, ASCII flat files, or HL7 format. Mandatory Mandatory
(ICU) (PACU)
1.3.3 Real time data from patient monitors, infusion pumps,
ventilators, assist devices, etc. extracted from the ICU-
CIS at frequencies independent of the display time period
and in accordance with Data Extraction requirements Tab
on this spreadsheet.
1.4 Data Standardization Mandatory Mandatory
(ICU) (PACU)
1.4.1 ICU-CIS data dictionary must meet all VA nomenclature Mandatory Mandatory
and standardization requirements. The ICU-CIS software (ICU) (PACU)
must use the most updated terminology consistent with
Uniform Data Dictionary, and/or Systematized
Nomenclature of Medicine, Clinical Terms (SNOMED CT),
and ICD-9, vocabulary throughout the contact period.
1.5 VistA Interface Must Demonstrate following Requirements Prior to Mandatory Mandatory
Functionality Contractual Obligation with VISN (ICU) (PACU)
1.5.1 All required interfaces (see Interface Section, 4.0) with Mandatory Mandatory
VistA must be certified prior to contract signing and (ICU) (PACU)
installation in VISN 23.
1.6 Remote Access and Off- ICU-CIS application must support remote view capabilities Mandatory Mandatory
line Viewing that allow one or more complete records to be viewed at (ICU) (PACU)
the same time from within the hospital outside of the ICU
and from outside hospital utilizing VPN and Citrix. When
remotely accessing the CIS from within the hospital, the
user should be able to have full functionality of the CIS.
Nat'l Mandatory Elements 2 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
1.6.1 One or more clinically active ICU-CIS records must be Mandatory Mandatory
able to be viewed entirely by authorized users or (ICU) (PACU)
administrators on remote, non-clinical workstations via the
local area network (LAN). Access to ICU-CIS records by
remote workstations must be via a browser-based
application or a special viewing program.
1.6.2 All off-site performance monitoring of ICU-CIS hardware Mandatory Mandatory
or software must satisfy VA Cyber-Security (ICU) (PACU)
Requirements, the Administrative Simplification provisions
of the Health Insurance Portability and Accountability Act
of 1996 (HIPAA), and the provisions of The Privacy Act of
1974 and its Veterans Affairs applications.
1.6.3 Remote support of the ICU-CIS server or workstation Mandatory Mandatory
software that is accomplished by the manufacturer (ICU) (PACU)
through remote access must satisfy VA Cyber-Security
Requirements, preserve firewalls, and meet Enterprise
Architecture Standards and VA security guidelines for
virus protection. An audit trail of all remote access must
be maintained.
1.6.3.1 Software or hardware upgrades must not disrupt or alter a Mandatory Mandatory
clinically active ICU-CIS record. An audit trail of all (ICU) (PACU)
software changes must be maintained. All upgrades must
be coordinated with COTR.
1.8 VistA/CPRS ICU-CIS application must not interfere with VA approved Mandatory Mandatory
Compatibility programs (including the following) (ICU) (PACU)
• BCMA
• VISTA/CPRS
• VISTA Imaging
• Internet Browser
• Microsoft Offices Products
• Java/Active X-Plug Ins
• SMS
• McAfee Virus Scan
• ISS Proventia firewall
• Sentillion Vergence Locator
• Analytic Database
• ARK remote view
• Brit PACS
• Employee Assists Program
• Windows 2000 Professional or Windows XP
• Employee Education LMS system
1.9 Implementation Implementation program must be specifically designed for Mandatory Mandatory
VISN 23 to leverage system knowledge and efficiencies (ICU) (PACU)
Nat'l Mandatory Elements 3 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
1.10 Maintenance program A uniform, multi-year maintenance program must be an Mandatory Mandatory
available option for VISN 23 and must include all (ICU) (PACU)
application upgrades, new versions, patches, etc. This
program must ensure that all VISN 23 sites are using the
same ICU-CIS version.
1.11 Device Drivers Device drivers to all VA medical devices for patient use in Mandatory Mandatory
OR, ICU, PACU, etc. must be capable of accepting all (ICU) (PACU)
data, measured and calculated. These drivers must be
available without additional cost to all VISN 23 sites for
existing and new equipment added to the VISN 23
inventory.
1.12 Device Features Once properly accessed, ICU-CIS workstations must Mandatory Mandatory
have the capability to toggle (foreground/background (ICU) (PACU)
continuous functionality) between the ICU-CIS
applications and other software applications used within
VISN 23 (see 1.8 for examples).
2.0 System
Requirements and
characteristics
2.1 Interoperability Must Demonstrate following Requirements Prior to
Contractual Obligation with VISN
2.1.1 ICU-CIS applications in every clinical monitoring location Mandatory Mandatory
[i.e. ICU, PACU] must provide interoperability capabilities (ICU) (PACU)
by either one of two methods below:
A) By joining data from diverse sources through
capabilities to interface with an Analytic Database,
sending images to VistA Image and using a 'remote view'
mode from the alternate ARK,
or
B) By an automatic and seamless exchange of data within
a hospital 1) to permit clinical review of all data at any
location in the hospital, 2) to provide integration of
continuing care data (fluids, drips, medications, etc.), and
3) to allow complete analyses of clinical care.
Nat'l Mandatory Elements 4 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
2.2 Technical Workstation Applications must be able to be run on the typical VA Mandatory Mandatory
Requirements and Requirements for ICU- workstation hardware as listed below. Any requirements (ICU) (PACU)
characteristics CIS that deviate from this standard must be clearly outlined.
Contractors will however be required to submit a list of
equipment required which will include the minimum
requirement for the ICU-CIS and Interface Software to
operate at an efficient level as intended. The list of this
equipment (including estimated pricing for each individual
item suggested) shall be provided with this signed
proposal and shall be included as defined in "Hardware
Requirements" Tab on this Spreadsheet.
3.0 Network
Requirements
3.1 ICU-CIS client application workstation shall be able to be Mandatory Mandatory
run with a standard 100 full duplex network connection to (ICU) (PACU)
the ICU-CIS server. The Contractor is required to submit
with his/her signed proposal, a list of any additional
network resources that are required for any associated
ICU-CIS connection. The above must be clearly outlined
and included with the Contractor‘s response as
Attachment D, Exhibit 1, Item 3. The VA shall provide
all necessary network hardware to meet this connection
speed.
3.2 The ICU-CIS Contractor shall provide a listing of port and Mandatory Mandatory
protocols used by the ICU-CIS system and include in (ICU) (PACU)
Attachment D, Exhibit 1, Item 3.
3.3 The ICU-CIS software shall be able to be run on PC Mandatory Mandatory
located on the hospital domain. (ICU) (PACU)
3.4 The ICU-CIS system shall be able to operate over VISN Mandatory Mandatory
23's WAN. Contractor shall ensure that VISN 23, should (ICU) (PACU)
it choose to, will be able to operate servers at remote
locations for decreased hardware maintenance. A
diagram of the existing VISN 23 WAN is included in this
RFP.
3.5 The CIS software shall have ability to operate off a WAN Mandatory Mandatory
link with common intra VISN network latencies of up to 30 (ICU) (PACU)
mS and VPN latencies of up to 100 mS
Nat'l Mandatory Elements 5 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.0 Required Medical VHA will provide a uniform
interface across all VISNs
Device and VistA
and hospitals to share
Interface information between VistA
Requirements and CIS used for the ICU,
(Note: vendor ARK, PACU and
must demonstrate Anesthesia Preop. The
interface primarily will use
following HL7 communications as
requirements prior well as VistA Broker Calls
to contractual (APIs). The vendor side of
obligation with the interfaces must be
developed, tested,
VISN.)
implemented and
supported according to
VHA standards provided
by Document Storage
Systems (DSS), 12575
US Hwy 1, Suite 200,
Juno Beach, FL 33408,
561-227-0207. DSS will
provide programming
specifications and
development support
upon request.
4.0.1 a. Medical Device
Interfaces (HL7 and
General Medical
Device Interfaces)
4.0.1.1 ICU-CIS device drivers or other electronic communication Mandatory Mandatory
means to all VA medical devices for patient use must be (ICU) (PACU)
capable of accepting all data, measured and calculated.
4.0.1.2 Provide direct connect or HL7 networked interfaces to all Mandatory Mandatory
VISN 23 site's physiologic monitoring systems and (ICU) (PACU)
medical devices for VISN 23 including all systems and
devices listed in Attachment E.
Nat'l Mandatory Elements 6 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.0.1.4 Additional medical device interfaces of the make/model Mandatory Mandatory
listed in Attachment E may be required as new equipment (ICU) (PACU)
is identified for interfacing to the ICU-CIS. These medical
device interfaces will be developed and provided at no
charge to the VA upon request of the VISN 23 COTR. If
however, interfaces are required for make/model devices
not listed in Attachment E, additional charges may apply.
The Contractor shall provide a written description of
Contractor's approach to adding additional medical device
interfaces and estimated pricing, if any, as defined in the
exhibit instructions.
4.0.1.5 Applications collecting data from medical devices shall Mandatory Mandatory
run as a background service and shall not require a user (ICU) (PACU)
to be interactively logged into the computer to collect the
data.
4.0.2 b. VistA Interfaces
Government
Furnished Property
4.0.2.1 Overview: The Contractor must provide interfaces to Mandatory Mandatory
solve the problem of electronic documentation, continuum (ICU) (PACU)
of care, advance clinical access, and clinical workflow in
critical care areas. The interfaces will exchange data bi-
directionally between VistA/CPRS and ICU-CIS
applications. The interface is a key element in the
creation of an electronic medical record for the critical
care areas.
4.0.2.2 The Government will furnish the appropriate interfaces to Mandatory Mandatory
operate on the VistA systems. These interfaces are (ICU) (PACU)
referred to as the VistA-side interfaces. That is, they
provide only one half of the interface requirements. The
successful Contractor will be responsible to provide the
other half, (the vendor-side) as part of this contract. The
Contractor shall coordinate the above with the Primary
COTR and will work with either VA staff and/or third party
Contractor to make a successful connection and transfer
of data with the VistA system through the Government
provided interface. If costs are incurred by the third party
to properly make the necessary interface connection(s)
operate correctly with the products provided by this
contract, it is the Contractor‘s responsibility to cover those
costs.
Nat'l Mandatory Elements 7 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.0.2.3 For this particular contract and the products being Mandatory Mandatory
acquired, the VistA-side interfaces have been developed (ICU) (PACU)
by a third party. That company is Document Storage
Systems (DSS), 12575 US Hwy 1, Suite 200, Juno
Beach, FL 33408, 561-227-0207.
4.0.3 c. Description of
Integration
Requirements
4.0.3.1 The functional integration requirements needed to meet Mandatory Mandatory
VHA requirements are listed below. The VA-side of the (ICU) (PACU)
VistA interface will be provided to the successful ICU-CIS
Contractor for the ICU-CIS. The ICU-CIS Contractor will
be required to have a VistA testing environment, QA staff,
and provide installation, training and support of the ICU-
CIS interface.
4.1 d. Vendor Side
Integration Interface
Components (CLIN
003-2)
4.1.a User Authentication
(Security) — For every
sign-on vendor software
will use the VA master list
to validate users and user
rights for the clinical
application through VistA
Broker Calls.
4.1.1 1. Purpose: To provide a single sign-on source for all Mandatory Mandatory
vendors using the VA master list permitting clinical users (ICU) (PACU)
access to an ICU-CIS using only VA passwords.
4.1.2 2. Description: Mandatory Mandatory
(ICU) (PACU)
4.1.2.1 a. Users will sign-on to ICU-CIS using their VistA Mandatory Mandatory
access/verify codes in a logon dialog box with asterisks (ICU) (PACU)
(***) displayed for both codes.
4.1.2.2 b. A separate authentication system is not maintained in Mandatory Mandatory
the ICU-CIS for standard logons. A shadow list may be (ICU) (PACU)
employed for use only when the network or CPRS is down
utilizing VA security standards. All changes in VA
access/verify codes must be used immediately for
subsequent ICU-CIS authentications.
Nat'l Mandatory Elements 8 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.1.2.3 c. A successful logon through VistA returns the user‘s Mandatory Mandatory
VistA credentials to the ICU-CIS, including — but not (ICU) (PACU)
limited to — user class, title, service, ICU-CIS
administrator.
4.1.2.4 d. The user group credentials will determine users‘ Mandatory Mandatory
privileges within the ICU-CIS. The ICU-CIS application (ICU) (PACU)
will allow creation of a ―user group‖ and assign user
groups specific levels of ICU-CIS access, such as
'read/write', 'read-only', specific template access
privileges.
4.1.2.5 e. The ICU-CIS may determine a user‘s user group by Mandatory Mandatory
querying the Vista interface for the user group(s) that a (ICU) (PACU)
user is assigned to.
4.1.2.6 f. The Vista interface determines the user group using Mandatory Mandatory
―rules‖ based upon the user‘s keys, title, and/or ASU user (ICU) (PACU)
class. Each site must also create keys matching the ICU-
CIS user group name.
4.1.2.7 g. Rules defining user groups are included with this Mandatory Mandatory
interface and individual VISNs may create their own as (ICU) (PACU)
well.
4.1.2.8 h. If the logon is unsuccessful, the user may not gain Mandatory Mandatory
further access to the application. (Logons will be limited (ICU) (PACU)
to a fixed number of failed attempts, e.g., <10.)
4.1.2.9 i. A temporary ‗work around‘ must become available to Mandatory Mandatory
allow users to logon only if network access is not (ICU) (PACU)
available. As soon as the network is available—and it is
feasible clinically—user must logon to the ICU-CIS by the
standard method.
4.1.2.1 j. Electronic Signature data will be sent to ICU-CIS to Mandatory Mandatory
0 allow provider signing in ICU-CIS, including notes and (ICU) (PACU)
records signed in ICU-CIS prior to sending to VistA.
Nat'l Mandatory Elements 9 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.2 Patient Selection /
Registration in ICU-CIS
— Individual patients will
be selected by methods
conforming to VistA
standards, minimizing
data entry, and by a
process similar to patient
selection in CPRS. Note:
the selection of patients
must occur through a
VistA query utilizing VistA
Broker calls (APIs).
4.2.1 1. Purpose: To accurately select individual patients and Mandatory Mandatory
send patient specific information to the ICU-CIS with (ICU) (PACU)
updates triggered by the ICU-CIS and VistA as
necessary. VistA identity management procedures are
maintained and extended within the ICU-CIS.
4.2.2 2. Description:
4.2.2.1 a. Patients will be selected from within ICU-CIS by Mandatory Mandatory
multiple methods including the following: (ICU) (PACU)
4.2.2.1. i. from a list in ICU-CIS, which must be updated Mandatory Mandatory
1 contemporaneously from ADT messages or poling the (ICU) (PACU)
Surgery Schedule when appropriate,
4.2.2.1. ii. utilizing a GUI similar to CPRS patient selection (e.g., Mandatory Mandatory
2 initial + ―last 4 SSN‖, Teams, wards), (ICU) (PACU)
4.2.2.1. iii. scanning patient‘s barcode, when it becomes available
3
4.2.2.1. iv. a ‗John Doe‘ option permitting use of the ICU-CIS Mandatory Mandatory
4 without first requiring patient registration in VistA (see (ICU) (PACU)
section e. below),
4.2.2.2 b. Patient identification information consists of multiple Mandatory Mandatory
identifiers and the ICU-CIS patient identification process (ICU) (PACU)
must meet VA standards (ENTR888 and ENTR942:
vendor transactions/messages from or to VistA shall be
capable of including the source identifiers within all
messages that exchange data with other VHA systems.)
Nat'l Mandatory Elements 10 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.2.2.3 c. Upon registration of a valid patient in the ICU-CIS, the Mandatory Mandatory
patient information will be sent to ICU-CIS triggered by (ICU) (PACU)
multiple events including query from ICU-CIS, ADT
message, surgery schedule message or patient
information update. The patient information, to be
updated in ICU-CIS, will include, not limited to, patient
identification identifiers, patient demographics, Code
Status, CWAD, bed location, treating specialty, etc..
4.2.2.3. i. New messages to ICU-CIS are sent for updates to the Mandatory Mandatory
1 patient data stored when MPI updates data in VistA. ICU- (ICU) (PACU)
CIS must update its database with the new data
contemporaneously.
4.2.2.3. ii. CWAD (Clinical Warnings and Advanced Directives) Mandatory Mandatory
2 will accompany patient registration/ADT messages, as (ICU) (PACU)
well as provide a ‗re-send message‘ trigger when
information is updated. If Patient Record Flags (Category
1 and 2) exist in VistA, transmit to ICU-CIS for display
including any changes/updates during that episode of
care.
4.2.2.3. iii. For each patient, ICU-CIS must accept VISN/hospital Mandatory Mandatory
3 specific team names, ICU locations (e.g., bed names) and (ICU) (PACU)
treating specialty names, (e.g., PACU, Pre-Op, Holding,
OR) to correctly identify patient locations and clinical
provider groups/teams.
4.2.3 d. Procedures must be included to allow the emergent, Mandatory Mandatory
manual entry of patient demographics entered into the (ICU) (PACU)
ICU-CIS prior to Registration through ADT in VistA. Easy
identification and resolution of any differences once VistA
registration is accomplished must be facilitated by ICU-
CIS.
4.2.4 e. There must be a simple, reliable method to retroactively Mandatory Mandatory
match duplicate identities stored within both systems with (ICU) (PACU)
‗John Doe‘ or incorrect patient assignments to prevent the
creation of duplicate patient records in ICU-CIS.
4.3 Patient Status
Information — Allergies
and Code Status
information is sent with
initial registration of
patient in ICU-CIS and
with all updates to
Status content.
Nat'l Mandatory Elements 11 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.3.1 A) Allergies — Current allergies in VistA are in separate Mandatory Mandatory
messages. A complete allergy set will be sent with a ICU- (ICU) (PACU)
CIS query, bed control (AO) or surgery scheduling (SR)
accompanied by pharmacy orders (ORM) based upon
actions within the CPRS, bed control or surgery
scheduling system, as well as patient registration in ICU-
CIS.
4.3.2 2. Purpose: To provide allergy data stored in VistA for Mandatory Mandatory
display in ICU-CIS. (ICU) (PACU)
4.3.3 3. Description: Mandatory Mandatory
(ICU) (PACU)
4.3.3.1 a. A read-only set of allergy data is sent in ICU-CIS for Mandatory Mandatory
display-only. (ICU) (PACU)
4.3.3.2 b. Allergy messages are triggered by event changes Mandatory Mandatory
managed in VistA. (ICU-CIS query, ADT, surgery (ICU) (PACU)
schedule, pharmacy orders, patient registration in ICU-
CIS, or modifications to allergy data)
4.3.3.3 c. Allergy updates made in VISTA must be updated Mandatory Mandatory
automatically and in real-time in the ICU-CIS. Changes (ICU) (PACU)
must be displayed in ICU-CIS both as a 'new' or 'critical'
data alert and in an updating data field.
4.4 Patient Information —In
general, patient data are
sent based upon 1) on a
process external to the
package (‘trigger’), 2) an
update or addition to the
package information, or
3) a query generated by
the ICU-CIS. Queries
may have multiple
parameters set to define
ranges of interest and
typically utilize VistA
Broker Calls (APIs).
(NOTE: Where
appropriate, all patient
data must be displayed
on timelines in the ICU-
CIS at the correct times
in graphic and tabular
formats.)
4.4.1 A) Lab Results — All verified lab ORM HL7 messages Mandatory Mandatory
will be sent to ICU-CIS including microbiology. (ICU) (PACU)
Nat'l Mandatory Elements 12 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.4.1.1 1. Purpose: To send hematology, microbiology, blood Mandatory Mandatory
bank and chemistry lab results to the ICU-CIS. (ICU) (PACU)
4.4.1.2 2. Description: Mandatory Mandatory
(ICU) (PACU)
4.4.1.3 a1. Hematology and chemistry lab results will be sent Mandatory Mandatory
from VistA Laboratory package to ICU-CIS for display. (ICU) (PACU)
No limitations can be placed on maximum number of
laboratory data (specific tests or numbers of test results).
4.4.1.4 a2. Microbiology and blood bank, including entire culture Mandatory
reports and antibiotic sensitivities, must be displayed. All (ICU)
parent / child reports must be included with each update.
4.4.1.5 b. ‗Out of range‘ and ‗critical value‘ labels will Mandatory Mandatory
accompany results as appropriate. ICU-CIS must accept (ICU) (PACU)
and display these data.
4.4.1.6 c. Results formats will be modified to permit ICU-CIS Mandatory Mandatory
to display logical categories (e.g., CBC panel) rather than (ICU) (PACU)
just alphabetical order.
4.4.1.7 d. Query capabilities initiated by ICU-CIS will mimic Mandatory Mandatory
CPRS (date range, specific results, etc.) (ICU) (PACU)
4.4.1.8 e. Changes must be displayed in ICU-CIS both as a Mandatory Mandatory
'new' or 'critical' data alert and in an updating data field. (ICU) (PACU)
4.4.2 B) Pharmacy Medication Schedules and Mandatory
Administration — All medications will be sent to ICU- (ICU)
CIS including include both outpatient and inpatient
medications.
4.4.2.1 1. Purpose: To send medications schedules and Mandatory
administration to the ICU-CIS for display-only. (ICU)
4.4.2.2 2. Description: Mandatory
(ICU)
4.4.2.3 a1. Pharmacy medication schedules, outpatient re-fills. Mandatory
(ICU)
4.4.2.4 a2. Inpatient administration events contained in BCMA Mandatory
will be sent contemporaneously to ICU-CIS for read only (ICU)
use
4.4.2.5 b. Verified and cancelled order messages will be Mandatory
included. (ICU)
4.4.2.6 c. Queries capabilities initiated by ICU-CIS will mimic Mandatory
CPRS (date range, specific results, etc.) (ICU)
4.4.2.7 d. All order modifications will be made Mandatory
contemporaneously in VistA and CPRS. (ICU)
4.4.2.8 e. VA Formulary will be sent to ICU-CIS. Mandatory
(ICU)
4.4.2.9 f. Changes must be displayed in ICU-CIS both as a Mandatory
'new' or 'critical' data alert and in an updating data field. (ICU)
Nat'l Mandatory Elements 13 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.4.3 C) Nursing and Dietary Orders — All Nursing and Mandatory
Dietary Orders will be sent to ICU-CIS in delimited (ICU)
form when available (e.g., restraint orders, pressure
ulcer, fall risk).
4.4.3.1 1. Purpose: Nursing and Dietary orders will be sent to Mandatory
provide treatment schedules in ICU-CIS. (ICU)
4.4.3.2 2. Description: Mandatory
(ICU)
4.4.3.3 a. Nursing and Dietary orders will be sent to ICU-CIS for Mandatory
read-only use. (ICU)
4.4.3.4 b. All order modifications will be made in VistA and Mandatory
contemporaneously displayed in ICU-CIS. Changes must (ICU)
be displayed in ICU-CIS both as a 'new' or 'critical' data
alert and in an updating data field.
4.4.4 D) Radiology Orders — All radiology orders will be sent Mandatory
to CIS. (ICU)
4.4.4.1 1. Purpose: radiology orders will be sent to facilitate Mandatory
nursing schedules in CIS. (ICU)
4.4.4.2 2. Description: Mandatory
(ICU)
4.4.4.3 a. Radiology orders will be sent to ICU-CIS for read-only Mandatory
use. (ICU)
4.4.4.4 b. All order modifications will be made in VistA and Mandatory
contemporaneously displayed in ICU-CIS. Changes must (ICU)
be displayed in ICU-CIS both as a 'new' or 'critical' data
alert and in an updating data field.
4.4.5 E) Vital Signs — Vital signs will be sent to ICU-CIS. Mandatory Mandatory
(ICU) (PACU)
4.4.5.1 1. Purpose: A record of the complete patient vital sign Mandatory Mandatory
information from VISTA (including O2 saturation and pain (ICU) (PACU)
scores, as available) will be sent to the ICU-CIS..
4.4.5.2 2. Description: Mandatory Mandatory
(ICU) (PACU)
4.4.5.3 a. Vital sign data will be sent to the ICU-CIS for use by Mandatory Mandatory
clinicians. (ICU) (PACU)
4.4.5.4 b. Updated data will be sent to the ICU-CIS. Mandatory Mandatory
(ICU) (PACU)
4.4.6 F) Problem List — Current Problem List entries will Mandatory
to be sent to ICU-CIS. (ICU)
4.4.6.1 1. Purpose: The Problem List contain information on Mandatory
current patient problems that may be valuable in (ICU)
assessing patients.
4.4.6.2 2. Description: Mandatory
(ICU)
4.4.6.3 a. The problem list is sent initiated by the standard Mandatory
triggers and modifications to the list. (ICU)
4.4.6.4 b. ICD-9 codes will be included. Mandatory
(ICU)
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Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.4.7 G) Notification of New Messages — A ‗Notification‘ Mandatory
message will identify all new messages sent to CIS. (ICU)
4.4.7.1 1. Purpose: The Notification message will be used by Mandatory
the ICU-CIS to alert the clinical user of new messages (ICU)
received by the CIS. The ICU-CIS will display the
message type in efficient and easily comprehensible
methods for clinical users (e.g., color coded icon
indicating 'new labs', 'out of range labs', 'new orders').
4.4.7.2 2. Description: Mandatory
(ICU)
4.4.7.3 a. When a new message is created, a second, Mandatory
‗Notification‘ message is sent also to the ICU-CIS (ICU)
identifying alerts, new lab values, etc.
4.4.7.4 b. The ICU-CIS will use the information in the Notification Mandatory
message to inform the clinical user of receipt of new data. (ICU)
4.4.7.5 c. The ICU-CIS will display a 'connection interrupted' Mandatory
message obvious to the clinical provider within 5 minutes (ICU)
of a communication interruption ( VistA, DSS, or network
failure) between the ICU-CIS and VistA.
4.5 Time Synchronization —
The times in the ICU-CIS
systems must be
synchronized with VistA.
4.5.1 1. Purpose: To have an accurate medical record the Mandatory Mandatory
ICU-CIS clocks must be identical to the VistA time. (ICU) (PACU)
4.5.2 2. Description: Mandatory Mandatory
(ICU) (PACU)
4.5.2 a. The ICU-CIS must receive a timing signal from the Mandatory Mandatory
interface and the synchronize the ICU-CIS time with the (ICU) (PACU)
VistA time.
4.6 VistA Imaging — A .Pdf
image is sent from ICU-
CIS to VistA Imaging will
be associated with a TIU
note.
4.6.1 1. Purpose: Since dense data and many data types Mandatory Mandatory
cannot be stored in VistA, the ICU-CIS must create an (ICU) (PACU)
image file for permanent, medical record storage in VistA.
4.6.2 2. Description: Mandatory Mandatory
(ICU) (PACU)
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Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
4.6.2.1 a. Images of the ICU flowchart, PACU record, and Mandatory Mandatory
anesthesia record will be created and sent to VistA (ICU) (PACU)
Imaging by the ICU-CIS at both pre-determined and user-
defined intervals for permanent display and storage.
4.6.2.2 b. The images will be attached to a TIU note title and Mandatory Mandatory
administratively signed. Must be able to attach provider (ICU) (PACU)
signature, when required.
4.6.2.3 c. Similar to paper flow sheets and records, the images Mandatory Mandatory
display the initials of the individual who entered a (ICU) (PACU)
particular value. The individual‘s full name is displayed as
a legend on the form.
4.6.2.4 d. PDF is the required format. Mandatory Mandatory
(ICU) (PACU)
4.7 TIU (Progress Note) — A
progress note is created
in the ICU-CIS and sent
to VistA.
4.7.1 1. Purpose: A TIU note signed by the clinician is created Mandatory Mandatory
in ICU-CIS and placed in CPRS Progress Notes. (ICU) (PACU)
4.7.2 2. Description: Mandatory Mandatory
(ICU) (PACU)
4.7.2.1 a. Progress notes created within ICU-CIS will be exported Mandatory Mandatory
to CPRS for permanent display and storage in VistA (ICU) (PACU)
Progress Notes.
4.7.2.2 b. The note may be reviewed, edited and electronically Mandatory Mandatory
signed in VistA. It may also be signed in the ICU-CIS or (ICU) (PACU)
administratively signed in VistA. The capability for both
approaches are required in the ICU-CIS.
4.7.2.3 c. All elements in the progress note are configurable by Mandatory Mandatory
the site. (ICU) (PACU)
4.7.2.4 d. Electronic signatures applied in ICU-CIS along with the Mandatory Mandatory
signed progress note will be transmitted to VistA. (ICU) (PACU)
4.7.2.5 e. Electronic signature information will be Mandatory Mandatory
accessed/validated in VistA at the time of signing into ICU- (ICU) (PACU)
CIS.
5.0 Additional ICU-CIS THE FOLLOWING CLINICAL ASSESSMENT
Clinical Assessment APPLICATIONS REQUIRE A RESPONSE AS TO
WHETHER YOUR SYSTEM HAS THE CAPACITY TO
Capabilities
ACCOMPLISH THE DESCRIBED ACTION.
Describe in detail and/or provide screen capture images
demonstrating how your application accomplishes the
desired action(s).
5.0.1 Patient name and SSN must be prominently displayed on Mandatory Mandatory
every page of the electronic display and record images. (ICU) (PACU)
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Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
5.1 Document body system Mandatory Mandatory
assessments (ICU) (PACU)
5.1.1 The capability to document body system assessments Mandatory Mandatory
sufficient to provide the Unit with a detailed head-to-toe (ICU) (PACU)
assessment that is configurable to each Unit, level of
care, facility and groups of patients e.g. liver transplant or
open heart.
5.1.3 The ICU-CIS must include severity scales. Severity Mandatory Mandatory
scales must be calculated automatically (with mandatory (ICU) (PACU)
manual data elements, as required), such as Apache II, III
and IV, APS, Braden, Aldrete, Glascow coma scale,
Morse fall scale, nutrition scoring, etc. as well as locally
created scores.
5.2 Manage calculations Mandatory Mandatory
and calculated data (ICU) (PACU)
5.2.2 The ability to perform manual and automatic clinical Mandatory Mandatory
calculations (ICU) (PACU)
5.3 Enter data and conduct Mandatory Mandatory
fluid balance (ICU) (PACU)
management
5.3.1 The ability of clinicians on different shifts to enter data into Mandatory Mandatory
a system that is capable of distinguishing fluids (blood, (ICU) (PACU)
drips, IV fluids, etc.) and manage continuous fluid balance
calculations inclusive of unit stay.
5.3.2 The ability to identify net negative I/O . The ability to Mandatory Mandatory
calculate net negative I/O and total I/O. Ability to auto (ICU) (PACU)
calculate I‘s and O‘s (data displayed by tables, variable
time periods, graphically, separated into colloid,
crystalloid, blood // urine, NG, chest tube, etc.) Ability to
see totals of Is and Os hourly, every 8 hr, every 24 hr, and
length of stay
5.3.3 The ability to document all blood product administration Mandatory Mandatory
as individual components. (ICU) (PACU)
5.4 Intuitive user interface Mandatory Mandatory
(ICU) (PACU)
5.4.1 The user interface should be easy and implicit: colors, Mandatory Mandatory
icons, graphs, pick lists, freeform text, notes, forms, point (ICU) (PACU)
and click, drop and drag, copy and paste and other
normalized Word-type capabilities are critical to reducing
errors.
5.4.2 The user interface must be compliant with Section 508 of Mandatory Mandatory
the Disabilities Act. (ICU) (PACU)
5.5 Charting Capabilities Mandatory Mandatory
(ICU) (PACU)
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Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
5.5.1 Step-down units: configurable fields and views according Mandatory Mandatory
to unit. (ICU) (PACU)
5.5.2 Ability to 'force' selection of entries from pick-lists to Mandatory Mandatory
minimize free-text (ICU) (PACU)
5.5.3 Ability to add structured notes for procedures, H&P, Mandatory Mandatory
patient problems (i.e., to facilitate SOAP or PIE charting) (ICU) (PACU)
etc.
5.5.4 A method must be in place that will allow the user to Mandatory Mandatory
annotate artifactual data, with an audit trail of corrected (ICU) (PACU)
data maintained. If the ICU-CIS has data-averaging
capabilities, an audit trail of automatic corrections must
also be maintained.
5.5.5 Ability to print q-shift and other summary reports Mandatory Mandatory
(ICU) (PACU)
5.5.6 Create, setup and manage administrations of infusions Mandatory Mandatory
and complex drips (ICU) (PACU)
5.5.7 Ability to auto calculate I‘s and O‘s (data displayed by Mandatory Mandatory
tables, variable time periods, graphically, separated into (ICU) (PACU)
colloid, crystalloid, blood // urine, NG, chest tube, etc.)
5.5.8 Display tabular and graphical values (including from Mandatory Mandatory
CPRS with vital signs, laboratory values, and other (ICU) (PACU)
data)—all on the same timeline
5.5.9 The ability to display I/O balance (preferably graphically) Mandatory Mandatory
over a user selected time period. (ICU) (PACU)
5.5.10 Ability to easily configure the flowchart to the individual Mandatory Mandatory
patient, i.e., add or subtract rows as patient condition (ICU) (PACU)
changes
5.5.11 Ability to document The Joint Commission patient safety Mandatory Mandatory
standards such as critical alarm settings, restraints, (ICU) (PACU)
patient education, etc.
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Ref. Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
7.1.1 Other
requirements
7.1.2 Flexibility Vendors must have the ability to configure the system for Mandatory Mandatory
various areas where VISN 23 may or will implement (i.e. (ICU) (PACU)
ICU, PACU, ED, small facilities, large tertiary care facilities).
7.1.3 System must have a method for guarding against user Mandatory Mandatory
errors to protect data format (i.e. numbers vs. text). (ICU) (PACU)
7.1.4 Fields of input Mandatory Mandatory
(ICU) (PACU)
7.1.5 Network Requirements ICU-CIS Contractor shall evaluate each site‘s network Mandatory Mandatory
capabilities. If ICU-CIS client will not run optimally on (ICU) (PACU)
existing LAN/WAN, ICU-CIS Contractor must inform VA as
to the necessary hardware and/or software that will enable
the Contractor‘s equipment to work optimally.
7.1.6 Additional ICU-CIS Clinical ICU-CIS shall have the capability for charted assessments Mandatory Mandatory
Assessment Capabilities/ to yield calculated scores. (ICU) (PACU)
Document body system
assessments
7.1.7 Additional ICU-CIS Clinical ICU-CIS Contractor must provide personnel resources to Mandatory Mandatory
Assessment Capabilities/ actively aid in the creation and configuring of our master (ICU) (PACU)
Export/import configuration database.
elements of an application to
same vendor application
7.1.8 ICU-CIS workstations must be able to operate with non- Mandatory Mandatory
proprietary hardware, including central processing units (ICU) (PACU)
(CPUs), keyboards, pointing devices (e.g. mice, light pens,
track balls, or touch screens), and computer monitors.
7.1.9 Easy for users to configure screens, for example to change Mandatory Mandatory
font size, without assistance from technical staff. (ICU) (PACU)
7.1.10 Configuration of Record Ability to enter and view CPRS and VISTA data while Mandatory Mandatory
Templates simultaneously logged onto the ICU-CIS system. (ICU) (PACU)
7.1.11 Easy to learn and intuitive to use. Descriptions of functions Mandatory Mandatory
rather than lots of icons. Minimum of steps. (ICU) (PACU)
7.1.12 ICU-CIS shall have the ability to integrate with other Mandatory Mandatory
information systems such as Real Time Location Systems (ICU) (PACU)
(e.g. RFID), tracking, electronic grease boards through
industry standard formats.
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Ref. Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
7.1.12.1 Ability to configure the appearance of the ICU-CIS (what the Mandatory Mandatory
user actually sees) so that the information which we deem (ICU) (PACU)
to be most important can be viewed on a single screen.
7.1.13 Vendor must be on-site at each facility for testing phases Mandatory Mandatory
prior to go-live and for the initial go live period. (ICU) (PACU)
7.1.14 Mandatory Mandatory
Clear audit trail for corrected data. (ICU) (PACU)
7.1.15 Ability to ―restore‖ previous charting data if patient Mandatory Mandatory
inadvertently discharged from CIS (ICU) (PACU)
7.1.16 Ability to view flowsheet ―rolled up‖ by Q4h, Q8h, Q12h, Mandatory
Q24h, etc. (ICU)
7.1.17 Flowsheet viewing and documentation at exact time (down Mandatory Mandatory
to the minute) (ICU) (PACU)
7.1.18 Ability to build flow sheets within the master sheet i.e. Skin Mandatory Mandatory
care, epidural, PCA flow sheets. (ICU) (PACU)
7.1.19 Ability to edit entries until a specified period of time has Mandatory Mandatory
passed. (ICU) (PACU)
7.1.20 Ability to control location of added rows–by someone with Mandatory Mandatory
the appropriate privileges in the CIS. (ICU) (PACU)
7.1.21 Ability to select groups of charting rows as a family for Mandatory Mandatory
standards of care i.e. Ventilator family, post open heart (ICU) (PACU)
family, insulin drip family, VAP family, etc.
7.1.23 Configuration Editor does not require programming (i.e. Mandatory Mandatory
language) knowledge but instead includes built in GUI tools (ICU) (PACU)
7.1.24 Create, select and score assessments against various Mandatory Mandatory
criteria (ICU) (PACU)
Criteria should include BCMA medication delivery data, Lab
data, Vitals data, I&O data etc.; and other standard scoring
systems like CIWA, MASS, Ramsey, etc.
7.1.25 All validated data will be available on the Pdf whether as Mandatory Mandatory
actual time by time entries or as footnotes where more than (ICU) (PACU)
one value per hour is present.
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Ref. Category Sub-category Element Mandatory Mandatory Vendor Response
(ICU) (PACU)
7.1.26 Mandatory Mandatory
Documentation of body assessments must include the (ICU) (PACU)
ability to copy forward from the last assessment. Copied
forward data can be accepted with minimal effort. Copied
forward data can be edited before storage. Entries can be
edited even if stored up to a fixed cut off time (12-24 hours)
selectable by unit, facility, or VISN. Each unit, facility or the
VISN can select automatic or manual charting. Back entry
of data where received from devices or manual entry is
allowable up to the fixed cut off time as selected by unit.
facility or VISN.
7.1.27 When there is a break in stay (transfer to ward with return Mandatory Mandatory
at a later date), the CIS clearly defines the I/O balances for (ICU) (PACU)
only the current stay, yet the previous stay balances are
reviewable.
7.1.28 Users may add annotation to any cell, field, where data is Mandatory Mandatory
manually entered or automatically downloaded from a (ICU) (PACU)
device. Annotations clearly identify the author.
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Ref. Category Sub-category Elements Vendor Response
1.13 National VISN System Workstation Provider/Patient Devices
Requirements
1.13.1 Does your ICU-CIS include input capabilities from Bar-Code readers, Swipe-card readers,
Real Time Location Systems, Biometric (fingerprint) identifiers, or others? Describe examples
of your implementations.
3.0 System Components
3.1 Hardware Please recommend workstation configurations that incorporate good human factors
engineering, and based on your experience, promote effective and safe use (considering
aspects such as ergonomics, flexibility, space requirements, display monitors, input devices,
etc.)
3.2 The ICU-CIS and Associated Networks
3.2.2 Identify networking infrastructure that you would expect each hospital and the VISN to provide
for your system implementation to operate well
3.2.3 Identify any network hardware and software expertise you would expect the VA to provide for
your system implementation to operate well.
3.2.4 Describe your experience deploying in a wireless network environment.
3.3 ICU-CIS Application Suite
3.3.1 If your ICU-CIS consists of a suite of applications or software options, describe each.
3.3.2 If applicable, please discuss the applications most commonly purchased.
3.3.3 If applicable, are there applications that other VA‘s do not commonly purchase? Describe.
3.4 ICU-CIS Database
3.4.2 What physiologic/device data are stored in your database? At what maximum frequency?
Are the data stored permanently? What data is available for queries?
3.4.6 The VISN and/or the vendor shall have the ability to add calculated variable fields to the
database.
3.4.7 The database shall have the ability to have new fields added to the database once ICU-CIS is
in clinical use.
3.4.7.1 Please describe the procedure for adding fields using specific examples.
Can new fields be calculated fields?
How are all workstations updated with new fields?
3.4.10 The ICU-CIS shall minimizes the amount of 'free text' entries and shall be site configurable
and shall allow text/numeric entries to have range limits, formats (numeric versus letters, etc.)
or other control mechanisms. (E.g., drop-down menus, pick lists, check boxes.) List all
fields/locations that only accept free text entries.
3.4.10.1 What programming languages may be used to generate reports from your ICU-CIS database?
Please provide examples of reports and how those reports are queried.
3.4.10.2 Please provide examples of your canned reports. What type of privileged user(s) typically
initiate reports? List examples. Can pre-defined/canned queries be modified?
3.4.10.3 How are new report queries created? What type of privileged user(s) typically initiate
queries? Can new computed/derived variables be created for reports?
3.4.10.4 What reports can be displayed graphically?
3.4.15 Describe the options for backing-up your ICU-CIS data. What is provided by the Contractor
with the ICU-CIS? What is the VA responsible to furnish?
3.4.16 Describe your solution for archiving your ICU-CIS data. Include data density, granularity and
storage requirement size relationships.
3.4.17 Specify backup media provided with the system. Can the system be archived and/or backed-
up to a network attached storage system (NAS) or storage area network (SAN)?
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3.5 ICU-CIS Technical Capabilities
3.5.3 Describe the relationship between your system server(s) and number of care units,
workstations, users that can be simultaneously supported.
3.5.8 Can application software (Patient and Remote) be pushed out to PC(s) or must it be loaded at
each individual workstation?
3.5.8.1 Describe recommended hardware as called for in optional CLINs.
3.5.17 Please indicate approximate range of data traffic levels (based on predictions of normal client
loads) on the ICU-CIS and associated networks.
3.5.19 Describe your requirements for IP addresses including total number of addresses
(approximate).
3.5.20 Describe possible ICU-CIS and associated networks and/or server failures. What would and
would not be affected by those failures?
3.5.21 Describe if ICU-CIS client application workstation shall be able to be run with a standard 100
MB full duplex network connection to the ICU-CIS server. The Contractor is required to
submit a list of any additional network resources that are required for any associated ICU-CIS
connection. The above must be clearly outlined and included with the Contractor‘s response
as Exhibit 1, Item 3. The VA shall provide all necessary network hardware to meet this
connection speed.
3.5.22 The ICU-CIS Contractor shall provide a listing of port and protocols used by the ICU-CIS
system and include in the exhibits.
3.5.24 Describe your system's self monitoring tools. How are network failures (including
performance degradation) identified by your system? How does your ICU-CIS notify the
system manager of failures? What does your ICU-CIS workstation display when a network
failure occurs? Describe or attach additional information.
3.5.25 Supply a flow chart/block diagram depicting the flow of data under usual operating conditions.
3.5.26 Include a diagram that illustrates all network components including hubs, routers, switches,
servers, etc.
4.2 Interfaces Patient Selection in CIS — Individual patients
will be selected by methods conforming to
industry standards, minimizing data entry, and
by a process similar to patient selection in
CPRS.
4.2.2.1.5 Does your ICU-CIS support CCOW integration? If so, please describe and include in your
proposal. List reference sites that have implemented CCOW with your application.
5.4 Additional ICU-CIS Intuitive user interface THE FOLLOWING CLINICAL ASSESSMENT APPLICATIONS REQUIRE A RESPONSE AS
Clinical Assessment TO WHETHER YOUR SYSTEM HAS THE CAPACITY TO ACCOMPLISH THE DESCRIBED
ACTION.
Capabilities
Describe in detail and/or provide screen capture images demonstrating how your application
accomplishes the desired action(s).
5.5 Charting Capabilities The ICU-CIS shall:
5.5.12 Does your ICU-CIS have the ability to store, display and extract monitor/device data
permanently at rates of 1 minute or less?
5.5.13 Does your ICU-CIS have the ability to simultaneously capture, store and export both high
resolution data (<=1 min in PACU ) as well as 'validated' data.
5.5.16 ICU-CIS must be capable of capturing physiological waveforms including date/time
annotation. Any necessary hardware to accommodate the monitoring system specifics in
Attachment E should be defined.
Provide evidence that your system has the ability to display and store waveforms from patient
monitors. Provide information on your systems‘ ability to import digital images of waveforms,
etc. Provide reference contacts who are using your method of managing ECG strips.
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5.5.17 Describe the ability to view various sections of the flow sheet by tabbing to them, i.e. Cardiac
assessment, neuro assessment, respiratory assessment, nursing care provided, procedures,
treatments.
5.5.18 Describe the ability to view various sections on the screen simultaneously, e.g.; vital sign,
vasoactive drips and I & O all at once. Provide an example.
5.5.19 Describe Printout capabilities and options
5.5.20 Describe Progress Note creation (auto entries, selections of entries during creation, multiple
types of notes, etc.) in ICU-CIS to be sent to VistA and local (VISN) ability to tailor note
content.
5.5.21 Describe how two or more users can chart on the same patient in the same time period.
5.6 Desirable ICU-CIS Clinical Assessment
Capabilities
5.6.2 Does your ICU-CIS have the ability to accept and plot calculated data from medical devices?
Does your system have the ability to ‗pull‘ data from all devices affecting the patient, including
(after the fact) emergency data?
5.1 Document body system assessments The ICU-CIS shall:
5.2 Manage calculations and calculated data
5.8.2 Describe the capability of your ICU-CIS to provide clinical reminders and alerts or
notifications. Can these reminders be date or time driven? Can they be site specific or area
specific?
Does your system have a method for alerting staff when a charting action needs to be
performed? Do such alerts include incomplete charting (e.g. pain charting was missed BID
dressing change missed.)
5.9 Describe the ability of the system to
Create/modify and monitor patient care
protocols and reminders for clinical
management
5.9.1 Describe any designated mandatory field alerts and required action item entry.
5.9.2 Alert provider of incomplete patient compliance measures/protocols
5.9.3 Allow individual unit systems managers to customize their ICU-CIS with alert date driven
reminders (when to change IV sites, etc.)
5.9.4 Describe ability of the ICU-CIS to update and display patient care and disease management
protocols
5.9.5 Describe the ability to have configurable ALERTS (e.g. Ventilator Days > #; Aspiration
precautions; Restraint checks; LOS for multidisciplinary conferences)
5.10 Export/import configuration elements of an
application to same vendor application
5.10.1 Describe your ability and approach to making database modifications, which can then be
propagated to other hospitals.
5.10.2 Describe in your software how new software versions maintain pre-existing structural
elements without corruption.
5.11 Describe the ability of your system to Capture
and store multi-disciplinary service
documentation, including the following
example situations
5.11.1 Capture and store multi-disciplinary service care (Respiratory Services, Physical therapy,
Occupational Therapy, Nutrition Service, Social work, Chaplin, ethics, BCMA Data review,
etc.).
5.14 Patient data summaries
5.14.1 Describe how multi-patient (rounds) summaries to be customizable for both nurses and
physicians and be able to print copies.
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5.16 Unlimited configuration abilities of families,
rows, columns
5.16.1 Do end users have the ability to access descriptors, pick list length, clinical pathways (i.e.
carotid), flow sheets, number of forms, and change font size, color, backgrounds, size etc.
should be user defined.
5.19 Conduct analysis and decision support for
care providers
5.19.1 Provide descriptions and examples of your decision support tools, including multiple data
points from a robust decision engine.
5.20 Describe the ability of your system to meet the
following features
5.20.4 Does the ICU-CIS have the ability to ―default‖ previously charted values into next charting cell
for acceptance or manually change.
5.20.8 Can graphs be defined on by users as needed with selectable variables and timelines?
Can users select multiple colors for flow sheets and graphs?
Provide instructions on how a user steps through this process.
5.20.12 Can flow sheet elements be grouped into logical subgroups (ABGs, CBC, etc)?
5.20.13 Can rows with no data in the viewable time range be collapsed (hidden)?
5.20.16 Can the ICU-CIS indicate by color change individual tabular values that are out of range. (VA
lab ranges must be utilized.)
5.20.20 Describe how all IV fluids, drug infusions included, are entered and tracked in your ICU-CIS.
Include screen shots.
5.20.22 Do you have a separate I&O chart view? What is included? Is any I&O excluded? Include
screen shots.
5.21 Administrative/Utilization Functions
5.21.3 Nurse and other provider assignments change each shift and also temporarily. Describe your
audit trails for tracking these changes?
How can users verify that the correct ICU-CIS record is displayed for the correct patient?
5.21.10 How does your ICU-CIS manage provider verification of different flowsheet/template
components (e.g., nursing and RT)?
5.21.10.1 Do you have an option to enter free text into a template cell?
5.21.15 How does your ICU-CIS handle an 'event'? (E.g. for cardiac arrest 'events' can ECG strips,
treatments, and flowsheet information be associated together?)
Can automatically populated fields be configured to require care nurse validation?
5.21.17 Describe your on-line help screens. Are help screens configurable?
5.22 Clinical Applications Coordinator (CAC)
5.22.1 Please describe your recommendations for VISN 23 personnel resources to support both
clinical and technical functions. Include recommended prior experiences, clinical and
technical capabilities, and hours/week required during both initial implementation and routine
operational periods.
5.22.3 Describe/list what clinical components (calculated cells, views, variables, forms, tables,
variables, etc.) that VA personnel can design. Include examples of the design processes. Do
you have a ‗VA‘ pre-defined setup of tables, variable, forms that a VISN could use?
5.22.9 What is the effective learning time before a VA super-user can start designing sheets?
5.22.15 Are there VA or non-VA user groups for your ICU-CIS product (numbers of participants,
meetings, purposes, etc.)?
5.22.17 Please describe the top five, most recent recommended changes or augmentations to your
ICU-CIS program obtained from your user groups.
Desirable Elements ICU-CIS 25 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
5.23 Vital Signs/Medical Device Interfaces
5.23.4 How can the rate of data storage in ICU-CIS be changed? Can the ICU-CIS data storage
rates be driven automatically by events/alarms, nurse options, or other? Please describe.
5.23.7 Do you have a buffer or 'continuous loop', high-density data storage system to recover prior
data in the event of an outage of any kind? How long is the temporary storage and what
limitations are placed on the stored data?
5.23.9 List reference sites, if any, that have interfaced infusion pumps to your ICU-CIS. Provide
make and model of pumps.
5.23.11 Have you interfaced with any medical telemetry systems? Elaborate on your technical
solution. Please detail which vendors you have worked with.
5.25 Maintenance and Warranty
5.25.4 Describe how you would leverage VA technical staff (e.g. Biomedical Engineering) to support
system.
5.25.13 How are bundles located? Can we configure where bundles are located in the flow
sheet?
5.25.16 Does your ICU-CIS allow for dual entry when dual nurse signature is required? Can
two nurses chart on the same patient, in the same cell, and have both authors
identified?
5.25.19 Do you have any capability for setting up clinical pathways (e.g. carotid)?
5.25.21 Can a user create a ICU-CIS record on an outpatient (someone who is not admitted
and will not be admitted)(e.g. ER)
5.25.22 Describe your ICU-CIS ability to:
1. Automatically populate the dose row when the user enters the IV volume
row
2. Provide defaulting rates* for drip present by volume in I/O section, (e.g.
500ml /c drug @ 12cc/hr)
3. Provide defaulting dose* for Vitals/Hemodynamic section, (e.g. drug dose
@ 6mg/hr)
*Meaning that those charting cells will default to the last value entered.
5.25.23 Describe the ICU-CIS capability to provide continuous daily weight change and
weight change (from admission weight) over LOS.
5.25.24 Can your system send alerts to a pager?
5.25.26 Describe the process for transferring a record from location to location including
within a facility and between facilities.
5.25.29 Please describe how a patient could be transported to a remote procedure, and
later have the information from the transport monitor downloaded into the ICU-CIS
system to update the ICU-CIS patient chart.
5.25.39 Describe any capabilities for annotating artifactual data, with an audit trail of
corrected data maintained. If the ICU-CIS has data-averaging capabilities, an audit
trail of automatic corrections must also be maintained.
5.25.41 Does the ICU-CIS allow for restricting the ability to leave a form until required fields
are completed?
5.25.63 How can emphasis be placed on important information for a particular day and/or
patient (e.g. use of highlighting)?
5.25.68 Describe your levels of user permissioning/access.
Desirable Elements ICU-CIS 26 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
5.25.71 Does the ICU-CIS have the ability to provide expandable ―cells‖ or ability to hover
over and see full contents of a cell?
5.25.73 Does the ICU-CIS have the capability to store images (i.e. wound pictures).
6.1.0 System is FDA 510(k) Clearance.
6.1.1 Describe your auto charting and manual verification of data before storage.
6.1.2 Changing the patient location Please describe the steps required moving a patient from one bed to another bed within
the same unit.
Describe the steps for transferring a patient from one unit to another unit within a facility
and from one facility to another VISN 23 facility.
6.1.3
6.1.4 Can the following information be viewed or input into the ICU-CIS from an ARK? Describe
any limiting factors (e.g. ARK vendor).
Total crystalloid
Blood products
Colloids
Urine output
Estimated blood loss (EBL)
Lines
Tubes
Drainage
6.1.5 Facilities must be able to select which elements of the flowsheet will be stored to the Pdf.
The VISN will work with the ICU-CIS vendor to configure the layout of the Pdf record.
6.1.6 What are your plans for the ARK to comply with the emerging standards from the IHE Patient
Care Device Domain?
Desirable Elements ICU-CIS 27 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
Configuration Typical Laptop/Notebook Premium Vendor Response
Processor 2.6 GHz 64-bit 2 GHz (64-bit 3+ GHz 64-bit (dual core
recommended) processors
recommended)
Memory (RAM) 1 Gb 1 Gb 2 Gb
Hard Drive 80 Gb 80 Gb 120 Gb
Video Card PCI Express Standard to laptop PCI 16x
CD-ROM/DVD Drive 16x CD/DVD RW CD/DVD RW 16x CD/DVD RW
Monitor 17” or 19” LCD Standard to laptop 19” or 22” standard and
wide screen LCD
LAN interface 10/100/1000 remote 10/100/1000 remote wake- 10/100/1000 remote
wake-on-LAN Ethernet on-LAN Ethernet interface wake-on-LAN Ethernet
interface, IPV6 ready card or docking station, interface, IPV6 ready
IPV6 ready; Wireless
802.11G/B modem
Keyboard 101-key Standard to laptop 101-key
Mouse MS-compatible Wheel MS-compatible Wheel or MS-compatible Wheel
or Button Mouse 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 Not authorized in most cases Not authorized in most
cases cases
Smart Card Reader Compliant with PC/SC Compliant with PC/SC Compliant with PC/SC
specifications and ISO specifications and ISO 7816 specifications and ISO
7816 Smart Card Smart Card Standards; must 7816 Smart Card
Standards; must be on be on Windows Hardware Standards; must be on
Windows Hardware Compatibility List (HCL). Windows Hardware
Compatibility List (HCL). Laptop external only. Compatibility List (HCL).
May be internal or May be internal or
external. external.
Other At least 4 Universal Universal Serial Bus 2 port At least 4 Universal
Serial Bus 2 port (2 with Serial Bus 2 port (2 with
front access) front access)
Operating system Windows XP Windows XP Windows XP
Windows Vista Windows Vista Windows Vista
Hardware Requirements 28 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
ICU-CIS Data Extraction Requirements
Vendor Response
Extracts from ICU-CIS data critical care and OR databases must be in a form suitable for
loading into the VISNs analytic environment; and perform as follows:
§ The extract will include all clinical and administrative data collected and/or displayed by the
clinical information system.
o The extract allows for all non – continuous data to be exported as stored in the primary
ICU-CIS database (not from a secondary reporting database).
o Continuous data will be extracted at a granularity set by the VISN but in any case, not less
frequently than every 60 seconds or the minimum storage interval, whichever is greater. Export
granularity for continuous monitored physiologic data may be as frequent as every 30 seconds.
§ Both validated and unvalidated data will be extracted.
§ The extract exports data on all patients with data in the system database at the time of the
extract regardless of their current status (active vs. discharged).
§ For each data value (observation) stored, the exported observation will include at a minimum
the following associated information, if available in the source ICU-CIS:
o The name of the variable (observation) as listed in the ICU-CIS data dictionary
o Storage format of the data (e.g. varchar, numeric)
o The data value of the observation
§ if the value is encoded, the decoded value must be provided
o The date and time of the observation
o Indicator for validated data, if present, and name of person validating
o Identifier linking the observation to the patient
o Identifier linking the observation to the hospital encounter (i.e. ICU stay)
o Identifier linking the observation to the source database (source table key)
o Name of the source table
o Name and version of the source ICU-CIS
o The normal range for the value if available in the database
o The source of the observed data, including
§ physical source (device) or identifier of staff making the observation
§ what is being recorded (electronic source, e.g., HR from ECG)
o Unit of measurement
o Patient location (unit and bed) at the time of the observation
§ Every data element will have a patient identifier including, but not limited to, Master Patient
Index and a timestamp, if available. If a timestamp is not available, then the data element will
include a unique key to it's associated encounter. The associated encounter must have a
timestamp.
§ The extract can handle the large volume of data associated with the extraction of very
granular physiologic data (e.g. q30 second heart rates). The extract runs efficiently and can be
run frequently allowing for daily updates from the clinical information system. Data may be
extracted by discharge date range, patient identification number, or date that a field was
updated (if such a date exists in the source ICU-CIS).
§ The extract exports data from the primary ICU-CIS database not a derived reporting database.
§ The extract denormalizes data related to “standardized” entries and the content of “formatted
field” entries, and “drop down” boxes and their associated fields, and changes.
Data Extraction 29 of 31
VISN 23 ICU-CIS Requirements
October 29, 2008
§ Export file format will reasonably meet industry standards for XML (preferred
methodology), HL7, or flat file transmission of data. Flat files will be limited to a reasonable
number (<50 files total) by combining like data elements into the same file and eliminating
unnecessary duplicates among files.
§ XML or HL7 exports will be grouped per patient with each patient's data in a separate file.
There will be only one file per patient containing all data.
§ Extracts are fully documented.
Extracts must be capable of detecting and extracting changes (edits) to data previously extracted
Extracts must be capable of transmitting the data to the analytics in a manner acceptable to
VISN security requirements (sftp or encrypted transmission is recommended).
Extracted data must be stored in a file folder in a location mutually agreed upon by VISN 23,
ICU-CIS Contractor, and Solution Analytics.
Data Extraction 30 of 31
VISN 23 WAN
National Back Bone
MPLS
45 mbps
ATM 45 mbps
45 mbps ATM
45 mbps
ATM
Omaha ASR ATM Minneapolis ASR
Cisco ASR 1006
ASR1000 SIP10
Cisco ASR 1006
ASR1000 SIP10
2 2
PWR STATUS
2 2 ASR1000 SIP10
1
PWR STATUS
ASR1000 SIP10
1
OC3 155mb 1
PWR STATUS
ASR1000 SIP10
1
PWR STATUS 0 0
ASR1000 SIP10
0 0 PWR STATUS
PWR STATUS P PWR
STAT
ACTV
STBY
1
ASR1000-ESP20
P PWR
STAT
ACTV
STBY
1
ASR1000-ESP20 P PWR ACTV 0
STAT STBY
ASR1000-ESP20
D
P PWR ACTV 0 CRIT HD
USB
CM1
STAT STBY PWR ACTV MAJ
AC0
ASR1000-ESP20 R STAT STBY MIN BF CARRIER LINK 1
0 1 DISK
ASR1000-RP1 CM1
BITS MGMT ETHERNET CON AUX
S3
CRIT HD CM1
USB CRIT HD CM1
PWR ACTV MAJ
AC0
STAT STBY MIN BF 1 PWR ACTV MAJ USB
AC0
R ASR1000-RP1 0 1 DISK
CARRIER
BITS
LINK
MGMT ETHERNET CON AUX R STAT STBY MIN BF CARRIER LINK 0
CM1
0 1 DISK
ASR1000-RP1 CM1
BITS MGMT ETHERNET CON AUX
CRIT HD CM1
PWR ACTV MAJ USB
AC0
R STAT STBY MIN BF CARRIER LINK 0
45
0 1 DISK
ASR1000-RP1 BITS MGMT ETHERNET CON AUX
b
CM1
m
m
45
b
S3
D
DS 3 4
45mb 5 mb
D S3
5 6 5 6
7206 3 4
7206 3 4
1 2 1 2
0 0
Des Moines IA Fort Meade SD
b
5m
4 5 mb
34
DS3
b
5m
DS
34
6 mbs 100 mbps
DS3 45mb
DS
5 6
DS3 45m
7206 3 4
DS
1 2
D
0
Metro E cloud
S3
34
Knoxville IA b
45
5m
5m
m
b 34
b
b
b
4 5m DS
D S3 100 mbps
DS
3
b b
45
m m
45 45
5 6
m
7206 3 4
b
5 6
S3 S3
1 2
7206 3 4
0
D D
1 2
0
Hot Springs SD
Lincoln NE
5 6
5 6
7206 3 4
5 6 5 6 5 6
7206 3 4
1 2
7206 3 4
7206 3 4
7206 3 4
1 2
0
1 2 1 2 1 2
0
0 0 0
Sioux Fall SD
Grand Island NE Iowa City IA Fargo ND St Cloud MN
DS3
Ethernet 10/100
45mb
Mb
ATM OC3 155 ATM PVC 8
Mb MB
