Sources Sought Notice – 65– 523-17-1-2697-0001 Infusion Pump IDIQ
Notice Type: Sources Sought Notice
Posted Date:
Office Address: White River Junction VAMC;
Subject: 65-- 523-17-1-2697-0001 Infusion Pump IDIQ
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: VA24117Q0193
Contact:
Description:
White River Junction VAMROC
This Sources Sought is for Infusion Pumps and Infrastructure to support them for a VISN-Wide IDIQ Contract for VISN 01 as shown in the attached specifications. The intent of this Request for information is to put in place a Base plus 4 Option Year Contract for the
Statement of Work
Infusion Pumps VISN1-WIDE
A.1 Instructions to Offerors
Veterans Integrated Support Network 1 (VISN 1) desires to offer its Medical Centers; including
The offeror shall include in their proposal the itemized cost schedule of all equipment, parts, software, software licensing fees, infrastructure (i.e.) servers and other network infrastructure devices), and services required to implement the proposed solution including on-going maintenance costs.
The offerors shall clearly identify any open market items (including pricing of such items) included in the proposal.
The Blanket Purchase Agreement will have a period of performance lasting five (5) years from date of award. The first year will refer to the base year with each subsequent year being an option year. The offeror must provide a supply of Infusion Pump System products for the life of the resulting BPA. At no time during the period of performance of this BPA shall the prices exceed the agreed upon BPA prices.
This BPA does not obligate any funds, nor is the Government obligated to make any purchases under this BPA.
As the order resulting from this RFQ will exceed the maximum order threshold for Schedule 65IIA, SIN A-64, the
The offeror shall submit a concise narrative (ten pages or less) of how their offer meets the technical requirement of the solicitation. The narrative shall contain all products which include all features listed as Required in Section A.2. The offerors shall not include equipment not meeting all required features in their proposal. Offerors shall indicate which features listed as Optional are included in the equipment offered.
Offerors shall fully describe the following items as part of their proposal:
Multi-Channel Capability
Power source, including type and number of batteries required
Wireless capability, including operating frequencies
Dimensions of equipment
Weight of equipment
Pump mechanism (Note: Positive pressure displacement is preferred)
Alarm detection mechanism
Software update and upgrade capabilities and implementation process of software updates and upgrades
Consumable set required
User training availability
Delivery Schedule
Drug library characteristics
Drug library update implementation process
Equipment expected life cycle
Parts List and pricing
Annual Support Fees and reoccurring maintenance fees for pumps and network infrastructure
Integration with Electronic Medical Record vendors
The Offeror shall also provide a proposal including required items to implement a full installation of the offeror s system across all of the VISN 1 facilities listed in Section A.3. The facility profiles are also listed in Section A.3. Currently, bed count is offered as a tool to assist with the offerors VISN 1 implementation proposal.
All quantity discounts shall be factored into the cost schedule for the full period of performance of this contract.
Delivery Schedule: The timeline and plan for implementation at each VISN 1 medical center is to be determined by each medical center individually or by the VISN offices. The Offeror shall assume that greater than fifty percent (50%) of the VISN will replace their inventory within the first two (2) years of the BPA.
Channel Capability: The offered equipment should be capable of up to four (4) channels to include but are not limited to large volume, syringe, PCA, and SPO2.
Software: The system and each component shall have a Dose Error Reduction system (DERS) that detects and prevents most dose-related programming errors and programming of inappropriate or unreasonable infusion.
The system and each component should permit configuration of its drug library to a facility s current ordering and delivery practices (i.e., customization of drug names, concentrations, and dosing units); and should be able to specify entire drug names.
The system and each component should permit a facility to set total dose and time limits for delivering boluses and intermittent infusions and to associate clinical advisories with any of the drugs/solutions in its library.
The software should maintain a history log that stores all drug libraries and limit sets by the date they were enabled and identifies all staff who has signed off on each library. The software should permit easy (e.g., spreadsheet), access-controlled review, editing, and batch programming of the facility s customized drug library and limit sets for each clinical location and application (i.e., for initial programming or for subsequent updates or configuration changes). A facility should be able to upload existing drug libraries to the software.
Software upgrade should not be burdensome; pumps should incorporate design elements that facilitate software upgrades
Offerors must describe the server requirements needed by the entire VISN to implement a full roll out of their solution if the VISN were to replace the entire inventory in the first year of the BPA. This shall include all of the proposed software, including all security access needed, data sharing, communication protocols, and functionality that the
Communication: The system should allow two-way wireless communication to transfer new drug libraries and software updates from a central server to the pumps, and to transfer events and alarm logs from the pumps to the server. The availability of wired communication is desirable in the event of a problem with the wireless network. Wireless communication should use existing technologies to allow hospitals to take advantage of existing infrastructure which are 802.11 a/b/g using both 2.4 gHz and 5 gHz. All wireless technology shall be FIP 140-2 compliant.
Consumables: The Offeror shall identify and describe all consumables which can be used by each component of the system and the cost for each item based on the profiles of the hospitals in Section A.3. All applicable quantity discounts shall be applied.
Equipment Cleaning: Offerors shall describe cleaning procedures and approved cleaning products for the offered equipment and state whether cleaning instructions are included in the product literature. The chemical makeup of the cleaning product shall be clearly identified in the offer.
Customer Support: Offerors shall describe the customer support program, including but not limited to in-house training for clinical users, biomedical support, and handling trouble calls.
Orientation/Training: Offerors shall describe the method of orientation and training of clinical users. The government desires training for clinical users and biomedical equipment personnel. Offerors should provide details on the vendor-provided training available and specify whether training is included with the equipment purchased or priced separately. If multiple training options are available, offerors should describe each in their offer.
Past Performance: As part of their proposal, offerors shall provide past performance information on their three most recent contracts of similar size and scope. Offerors shall complete RFQ attachment 1, Past Performance Reference Sheet and return along with their offer. The Offeror shall provide a list of all recalls and alerts pertaining to their product line for the past three (3) years from the date of the solicitation.
Integration: As part of their proposal, the Offerors shall provide a list of tested and verified Electronic Medical Record systems (i.e., Computerized Patient Record System (CPRS),
EVALUATION OF OFFERORS
All quotations will be evaluated to confirm that products offered contain all required features. Of those that do, the successful offeror will be selected on a best value basis with the following factors being considered in the award decision: (The factors are listed in descending order of importance)
Quality of product
Past performance
Recall history
Life Cycle
Network Capability
Optional features offered as listed in Section A.2 VISN 1 Optional Features List
Equipment Cleaning
Cleaning procedures
Process
Materials
Frequency of cleaning
Training
Scheduling
Methods
Categories (i.e. User, Super User, Admin,
Cost of full VISN implementation
The inclusion of optional features and descriptions provided in the proposal will be used by technical representative to determine which equipment best meets their needs for effective program performance.
A.2 Specifications
Listed below are the functional parameters for the infusion pumps required by the RFQ. Products being offered shall include all features listed as required. Offerors shall not include equipment not meeting required features in their proposal.
Offerors shall state whether the offered products include features listed as optional.
VISN 1 Required Features
ID
Feature
Note
1
Automatic Piggybacking
*-
2
Dose Error Reduction System (DERS)
*-
3
IV Set
*-
*-
a. Free-Flow Protection
*-
*-
b. Needleless IV Connection
*-
4
Front-Panel Lockout
*-
5
Alarms and Indicators
*-
*-
a. Occlusion upstream alarm
*-
*-
b. Occlusion downstream alarm
*-
*-
c. infusion complete indicator
*-
*-
d. Air in line alarm
*-
*-
e. Empty fluid container indicator
*-
*-
f. flow error indicator
*-
*-
g. Set disengaged alarm
*-
*-
h. Door open indicator
*-
*-
i. Circuit malfunction alarm
*-
*-
j. Battery Status
*-
*-
k. Low battery alarm
*-
*-
l. Depleted battery alarm
*-
*-
m. Controllable alarm volume
*-
*-
n. Pressure, psi alarm
Max 15 psi
6
0.1-999
7
Total Volume Infused Displayed in ml/hr
*-
*-
a. units of measure
ml
*-
b. units of time
hours
8
Data Log
*-
*-
b. Time/date stamp
*-
*-
c. Number of events
Minimum 200
*-
d. Events to be stored in Data log
Key presses, error codes, alarms, amount infused
9
Allowed Disinfectants
EPA Grade
10
Fluid Resistant
Internal and External
11
Power Source
*-
*-
a. Life, (in hours @ flow(mL/hr))
Min 4 hrs w/all channels running 100ml/hr
*-
b. Recharge Time, hr
No more than 10 hours
12
Pump can drug/dose calculate
*-
13
EtCO2 capability linked to PCA drug delivery
*-
14
EMR Integration
*-
15
Data Port
*-
*-
*-
*-
VISN 1 Optional Features
ID
Feature
Note
1
Max Unit Per Pole
up to 4
*-
Alarm Volume Lock
*-
*-
Alarm Silence Feature
*-
*-
a. Display
Shown on Pump
*-
e. Data Log File Format
Excel; .txt; word
*-
a. Units of Measure
Nanograms
*-
Total Volume Infused Displayed
*-
*-
a. Time period
Minute
2
VTBI Selector, ml
*-
3
Duplicate Drug Entries for multiple uses of the drug
*-
4
Nurse call jack
*-
5
IV Set
*-
*-
a. Air-trapping capability
*-
*-
b. Multiple brand usability
*-
*-
c. Multiple types of IV Set
ex. Straight tubing
6
Alarms and Indicators
*-
*-
a. User prompts indicators
*-
*-
b. Sounds
*-
7
Data Log
*-
*-
a. Printout
*-
8
Expansion of PCA functionality
*-
9
MRI Compatible
*-
10
Multi-Step Drug Delivery Programming
*-
11
Bolus Delivery Programming
*-
12
Reporting
*-
*-
a. Real time data management
*-
13"-
Network Connection
*-
*-
a. Wireless
*-
*-
b. FIPS 140-2 Compliant
*-
A.3 VISN 01 Facility Profiles
ID
Facility
Total Bed Count
Hospital Bed Count
Nursing Home Bed Count
Domiciliary
0001
West Roxbury Campus
Jamaica Plain Campus
Brockton Campus
559
349
112
98
0002
West Haven Campus
Newington Campus
191
119
40
32
0003
Bedford VAMC
402
48
304
50
0004
Providence VAMC
73
73
0
0
0005
VA Central Western Massachusetts
113
81
32
0
0006
VA
1 VA Center
159
71
88
0
0007
VA
112
0
112
0
0008
VA
74
60
0
14
*The total bed count is the summation of the Hospital Bed Count, Nursing Home Bed Count, and Domiciliary bed count
A.3 Security Clauses
GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as
ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
A contractor/subcontractor shall request logical (technical) or physical access to
All contractors, subcontractors, and third-party servicers and associates working with
Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared
Custom software development and outsourced operations must be located in the
The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a
3. VA INFORMATION CUSTODIAL LANGUAGE
Information made available to the contractor or subcontractor by
Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from
The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of
The contractor/subcontractor shall not make copies of
f. If
privacy, and security provisions of the contract, it shall be sufficient grounds for
If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.
The contractor/subcontractor must store, transport, or transmit
The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed
Except for uses and disclosures of
Notwithstanding the provision above, the contractor/subcontractor shall not release
For service that involves the storage, generating, transmitting, or exchanging of
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
All electronic storage media used on non-
Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with
Vendor must accept the system without the drive;
Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the
The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using
A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. SECURITY INCIDENT INVESTIGATION
The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to
To the extent known by the contractor/subcontractor, the contractor/subcontractor s
notice to
(including to whom, how, when, and where the
compromised), and any other information that the contractor/subcontractor considers relevant.
With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with
7. LIQUIDATED DAMAGES FOR DATA BREACH
Consistent with the requirements of 38 U.S.C. --5725, a contract may require access to sensitive personal information. If so, the contractor is liable to
The contractor/subcontractor shall provide notice to
Each risk analysis shall address all relevant information concerning the data breach, including the following:
Nature of the event (loss, theft, unauthorized access);
Description of the event, including:
date of occurrence;
data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
Number of individuals affected or potentially affected;
Names of individuals or groups affected or potentially affected;
Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
Amount of time the data has been out of
The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
Known misuses of data containing sensitive personal information, if any;
Assessment of the potential harm to the affected individuals;
Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the
individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
Notification;
One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
Data breach analysis;
Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
One year of identity theft insurance with
Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. SECURITY CONTROLS COMPLIANCE TESTING
On a periodic basis,
9. TRAINING
a. All contractor employees and subcontractor employees requiring access to
information and
access to
(1) Sign and acknowledge (either manually or electronically) understanding of and
responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to
access to
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior
training and annually complete required security training;
(3) Successfully complete the appropriate
required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for
official and provided to the contracting officer for inclusion in the solicitation document e.g.,
any role-based information security training required in accordance with NIST Special
Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
Attachment 1
PAST PERFORMANCE REFERENCES
REFERENCE 1:
Contracting Activity Name: _________________________________
Location: __________________________________
Contract number: ___________________________
Point of contact: ____________________________
Telephone Number: _________________________
Dollar Amount: _________________
Brief Description of Services provided: _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
REFERENCE 2:
Contracting Activity Name: _________________________________
Location: __________________________________
Contract number: ___________________________
Point of contact: ____________________________
Telephone Number: _________________________
Dollar Amount: _________________
Brief Description of Services provided: _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
REFERENCE 3:
Contracting Activity Name: _________________________________
Location: __________________________________
Contract number: ___________________________
Point of contact: ____________________________
Telephone Number: _________________________
Dollar Amount: _________________
Brief Description of Services provided: _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Past Recalls
Recall Number: ____________ _____________________
Recall Description: _________________________________
Recall Date: __________________ ________________
Recall Level/Class: ________________ ___________
Brief Description of Recall Issue and:
Recall Number: ____________ _____________________
Recall Description: _________________________________
Recall Date: __________________ ________________
Recall Level/Class: ________________ ___________
Brief Description of Recall Issue and:
Recall Number: ____________ _____________________
Recall Description: _________________________________
Recall Date: __________________ ________________
Recall Level/Class: ________________ ___________
Brief Description of Recall Issue and:
This Notice of Intent is NOT a request for competitive proposals. Parties may identify their interest, accompanied by supporting literature, to the Contract Specialist no later than
p.m. Responses should be sent to Mary.Bosch@va.gov. Information received will be for the purpose of determining whether or not to conduct a competitive procurement. The determination to conduct a
competitive or set-aside procurement based on responses to this notice is solely within the discretion of the Contracting Officer.
Link/URL: https://www.fbo.gov/spg/VA/WRJVAMROC/DVAMROC/VA24117Q0193/listing.html
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