Sources Sought RFI NX EQ Heart Lung Bypass.docx

DOCX document 68 KB Posted Dec 11, 2024

Attached to: NX EQ Heart-Lung Bypass Units
Solicitation number: 36C10G25Q0027
Issued by: Department of Veterans Affairs Headquarters

About this file

Written by GovTribe AI · Dec 11, 2024

This is a Sources Sought notice from the Department of Veterans Affairs (VA) Strategic Acquisition Center seeking qualified sources to provide LivaNova Essenz Perfusion System Heart-Lung Bypass Units or equal products. Responses are due by December 20, 2024 at 9:00 AM EST. The VA intends to award a single Requirements Contract with Firm-Fixed Price orders for one 12-month base period and four 12-month option periods.

The requirement is for heart-lung bypass units designed for cardiopulmonary bypass and extracorporeal circulation procedures, with key components including arterial pumps, suction pumps, cardioplegia pumps, and backup systems. The solicitation includes 159 contract line items covering the main console units and various components/accessories, with quantities of 10-40 units per item annually. Key salient characteristics require the units to have uninterruptable power supply, user interface, modular configuration capabilities, and parameter monitoring/display functions. The NAICS code is 334510 with a size standard of 1,250 employees. Vendors must demonstrate ability to provide nationwide delivery to VA medical centers and submit technical literature showing compliance with salient characteristics, service plan details, and company information including manufacturing/distribution status.

View the file

On GovTribe

Work with this file

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

Sources Sought Notice Sources Sought Notice

SUBJECT*

NX EQ Heart-Lung Bypass Units

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*

22408-2697

SOLICITATION NUMBER*

36C10G25Q0027

RESPONSE DATE/TIME/ZONE

12-20-2024 9:00AM EASTERN TIME, NEW YORK, USA

ARCHIVE

30 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

PRODUCT SERVICE CODE*

6515

NAICS CODE*

334510

CONTRACTING OFFICE ADDRESS

U.S. Department of Veterans Affairs

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Trevor Mason Trevor.Mason@va.gov 202-867-4351

PLACE OF PERFORMANCE

ADDRESS

Nationwide

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

https://www.va.gov/opal/sac/index.asp

URL DESCRIPTION

VA | OALC | OPAL | SAC

AGENCY CONTACT’S EMAIL ADDRESS

Trevor.Mason@va.gov

EMAIL DESCRIPTION

Trevor.Mason@va.gov

DESCRIPTION

1.0 DESCRIPTION

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The Department of Veterans Affairs’ (VA) Strategic Acquisition Center (SAC) is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) as a means of conducting market research to identify qualified sources with the capability and the resources to meet the Veterans Health Administration’s (VHA) Non-Expendable Equipment National Program requirement for Heart-Lung Bypass Units.

The SAC in conjunction with VHA is seeking a qualified source to supply brand name or equal LivaNova® Essenz Perfusion System units and associated equipment on an agency-wide basis. VA intends to award a single Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Heart-Lung Bypass Units to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 employees.

The FAR Provision found at 52.204-7(b)(1) requires that “All interested Offerors must be registered in SAM prior to submitting an offer or quotation.” You may access the SAM website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of submission.

Submissions for this “sources sought” shall be submitted by email no later than December 20, 2024, at 9:00am EST to all the following:

Trevor.Mason@va.gov Sara.Vickroy@va.gov This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time.

2.0 SCOPE OF WORK

The LivaNova® Essenz Perfusion System (Heart-Lung Bypass Units) or equal are designed to provide temporary external circulatory support to the cardio-pulmonary functions by oxygenating the body's venous supply of blood and pumping it back into the arterial system; bypass units perform circulation oxygenation and filtration of the blood. These units are usually assembled in a console, are modular, and contain main components consisting of an arterial pump, a backup arterial pump, one or two suction pumps, an arterial vent pump, a cardioplegia pump, and a backup unit along with some disposable components such as an oxygenator/heat exchanger, a cardiotomy reservoir, blood filters, and tubing.

Heart-Lung Bypass Units are mostly used during open heart surgery, bypassing the heart to facilitate surgery on the organ (e.g., cardiac valve replacement, coronary artery bypass grafting) and are also used for extracorporeal membrane oxygenation in patients with severe respiratory disorders.

The following Contract Line Items are being considered:

Contract Line Items

Brand

Part Number

Description

Base Year Qty

Option 1

Qty Option 2 Qty Option 3 Qty Option 4 Qty

0001
LivaNova
Base Unit
LivaNova Base Unit (Essenz Perfusion System / Heart-Lung Bypass Unit) 4 Pump Console (includes: Timer, power supply, emergency power supply, electronic and power supply pack, mast system, hand crank, hand crack bracket, poles, uninterruptable power supply/battery back- up, and vacuum regulator), Focus Data Yr1 (MPN 80700046), and Data Connectivity Installation
10
10
10
10
10

0002
LivaNova
CP Long
Centrifugal Pump Long
10
10
10
10
10

0003
LivaNova
CP Short
Centrifugal Pump Short
10
10
10
10
10

0004
LivaNova
49-00-10
Console
10
10
10
10
10

0005
LivaNova
EGB10L
Electronic Gas Blender - 10L
30
30
30
30
30

0006
LivaNova
EGB2L
Electronic Gas Blender - 2L
30
30
30
30
30

0007
LivaNova
EGB5L
Electronic Gas Blender - 5L
30
30
30
30
30

0008
LivaNova
25-28-68
Electronic Gas Blender - 5L
30
30
30
30
30

0009
LivaNova
25-28-69
Electronic Gas Blender - 2L
30
30
30
30
30

0010
LivaNova
CP Kin Assist
Centrifugal Pump Kinetic Assist
10
10
10
10
10

0011
LivaNova
60-04-50
Centrifugal Pump Drive
10
10
10
10
10

0012
LivaNova
25-28-67
Electronic Gas Blender
10
10
10
10
10

0013
LivaNova
ILBM - VA
In-Line Blood Monitor Complete
10
10
10
10
10

0014
LivaNova
RP150 Large
Large Roller Pump
10
10
10
10
10

0015
LivaNova
10-90-00
Large Roller Pump
10
10
10
10
10

0016
LivaNova
RP85 Small
Small Roller Pump
10
10
10
10
10

0017
LivaNova
VC Ven Clamp
Venous Clamp
10
10
10
10
10

0018
LivaNova
96-415-140
Perfusion System Monitor
10
10
10
10
10

0019
LivaNova
12-80-40
Electronic Venous Clamp
10
10
10
10
10

0020
LivaNova
10-95-00
Small Roller Pump
10
10
10
10
10

0021
LivaNova
ILBM - V
In-Line Blood Monitor Venous
10
10
10
10
10

0022
LivaNova
96-414-180
Arterial Sensor & Reference Element
10
10
10
10
10

0023
LivaNova
60-05-35
Arterial Clamp - Long Arm
10
10
10
10
10

0024
LivaNova
60-05-30
Arterial Clamp - Short Arm
10
10
10
10
10

0025
LivaNova
49-10-01
Cabinet Assembly Right
10
10
10
10
10

0026
LivaNova
49-10-99
Cabinet Assembly Left
10
10
10
10
10

0027
LivaNova
96-414-170
Venous Sensor & Reference Element
10
10
10
10
10

0028
LivaNova
49-05-13_01
Mast System
10
10
10
10
10

0029
LivaNova
28-97-10
Cockpit
10
10
10
10
10

0030
LivaNova
25-95-10
B-Capta Module Adapter
10
10
10
10
10

0031
LivaNova
96-490-042
Mechanical Gas Blender, O2 & Air
10
10
10
10
10

0032
LivaNova
12-40-00
Mechanical Venous Line Clamp
10
10
10
10
10

0033
LivaNova
Control Unit
Control Unit
10
10
10
10
10

0034
LivaNova
Level
Level
10
10
10
10
10

0035
LivaNova
23-65-10
Bubble Module
10
10
10
10
10

0036
LivaNova
28-96-00
Control Unit
10
10
10
10
10

0037
LivaNova
19-03-00
Bracket for Gas Bottles
30
30
30
30
30

0038
LivaNova
49-05-13_02
Mast System
10
10
10
10
10

0039
LivaNova
23-41-10
Level Module
10
10
10
10
10

0040
LivaNova
49-10-30
Main Interface Box
10
10
10
10
10

0041
LivaNova
96-490-131
Air Tubing Set for Mechanical Gas Blender
10
10
10
10
10

0042
LivaNova
96-490-132
O2 Tubing Set for Mechanical Gas Blender
10
10
10
10
10

0043
LivaNova
96-414-220
Flow Sensor 3/16"
30
30
30
30
30

0044
LivaNova
96-414-230
Flow Sensor 1/4"
30
30
30
30
30

0045
LivaNova
96-414-240
Flow Sensor 3/8"
30
30
30
30
30

0046
LivaNova
96-414-250
Flow Sensor 1/2"
30
30
30
30
30

0047
LivaNova
49-05-65
Cable Box
10
10
10
10
10

0048
LivaNova
60-04-55
Centrifugal Pump Emergency Drive
10
10
10
10
10

0049
LivaNova
22-20-10
Pressure Module
30
30
30
30
30

0050
LivaNova
49-05-11
Support Plate
10
10
10
10
10

0051
LivaNova
28-96-60
Control Unit Arm
10
10
10
10
10

0052
LivaNova
96-414-320
Bubble Sensor 3/16"
30
30
30
30
30

0053
LivaNova
96-414-330
Bubble Sensor 1/4"
30
30
30
30
30

0054
LivaNova
96-414-340
Bubble Sensor 3/8"
30
30
30
30
30

0055
LivaNova
96-414-350
Bubble Sensor 1/2"
30
30
30
30
30

0056
LivaNova
25-60-10
Flow Module
10
10
10
10
10

0057
LivaNova
050350000
PAS SECHRIST 3500 CP-G Adapter
10
10
10
10
10

0058
LivaNova
50-70-57
C-Shaped Mast
10
10
10
10
10

0059
LivaNova
80700046
FOCUS Data Fee - Annual - Essenz Perfusion System focus data annual software license and subscription. Required annual renewal to maintain active updates and software functionality. Included in first year purchase of Base Unit.
10
10
10
10
10

0060
LivaNova
20-30-10
Temperature Module
10
10
10
10
10

0061
LivaNova
49-05-29
Extension Arm
10
10
10
10
10

0062
LivaNova
49-05-24
Arterial Extension Arm
10
10
10
10
10

0063
LivaNova
12-30-90
Mechanical Venous Clamp Holder
40
40
40
40
40

0064
LivaNova
41-02-98
Perfusion Chair
10
10
10
10
10

0065
LivaNova
49-10-61
Shelf
10
10
10
10
10

0066
LivaNova
28-96-50
Control Unit Double Holder
10
10
10
10
10

0067
LivaNova
45-04-03
Medex Transducer
10
10
10
10
10

0068
LivaNova
73-200-520
Cockpit Arm
10
10
10
10
10

0069
LivaNova
10-95-80
Twin Holder
10
10
10
10
10

0070
LivaNova
96-403-072
Power Plug 230V
10
10
10
10
10

0071
LivaNova
23-41-50
Level Sensor
10
10
10
10
10

0072
LivaNova
49-05-20
Table Set Mast
10
10
10
10
10

0073
LivaNova
35-05-85
Lamp
10
10
10
10
10

0074
LivaNova
25-95-70
Venous Sensor Holder
10
10
10
10
10

0075
LivaNova
25-95-80
Arterial Sensor Holder
10
10
10
10
10

0076
LivaNova
96-490-111
Air Tubing Set for Electronic Gas Blender
10
10
10
10
10

0077
LivaNova
96-490-112
O2 Tubing Set for Electronic Gas Blender
10
10
10
10
10

0078
LivaNova
96-490-113
CO2 Tubing Set for Electronic Gas Blender
10
10
10
10
10

0079
LivaNova
96-403-073
Power Plug 120V
10
10
10
10
10

0080
LivaNova
97-102-244
Control Unit System Cable
10
10
10
10
10

0081
LivaNova
0395-2049
SPD Truwave Xducer Cable
10
10
10
10
10

0082
LivaNova
24-10-10
Mast Holder with Fast Clamp Connector
10
10
10
10
10

0083
LivaNova
45-12-74
Dräger Infinity, SC9000 Adapter
10
10
10
10
10

0084
LivaNova
25-30-50
Accessories Kit for plugging into Mechanical Blender
10
10
10
10
10

0085
LivaNova
23-41-51
Level Pads - 100 pcs
10
10
10
10
10

0086
LivaNova
45-12-64
Marquette Monitor 5m Adapter
10
10
10
10
10

0087
LivaNova
Long Support
Long Support
10
10
10
10
10

0088
LivaNova
042229000
Inspire Oxygenator Temp Probe
10
10
10
10
10

0089
LivaNova
45-10-50
Equalization Cable
10
10
10
10
10

0090
LivaNova
Short Support
Short Support
10
10
10
10
10

0091
LivaNova
24-30-15
Mast Holder for Power Adapter with Fast Clamp Connector
10
10
10
10
10

0092
LivaNova
10-61-92
Variolock Tubing Clamp Insert 2:1
40
40
40
40
40

0093
LivaNova
10-61-94
Variolock Tubing Clamp Insert 4:1 (USA only)
40
40
40
40
40

0094
LivaNova
48-30-75
INFUSION RACK CPL Essenz
10
10
10
10
10

0095
LivaNova
10-61-72
Insert Varilock, BLUE
10
10
10
10
10

0096
LivaNova
10-61-73
Insert Varilock, RED
10
10
10
10
10

0097
LivaNova
10-61-91
Variolock Tubing Clamp Insert 1:1
40
40
40
40
40

0098
LivaNova
49-05-35
Tray - Right Side
10
10
10
10
10

0099
LivaNova
49-05-39
Tray - Left Side
10
10
10
10
10

0100
LivaNova
49-05-41
Pump Support
10
10
10
10
10

0101
LivaNova
050350100
SECHRIST IV308 Hose Air 14 FT Adapter
10
10
10
10
10

0102
LivaNova
050350200
SECHRIST IV309 Hose Oxy 14 FT Adapter
10
10
10
10
10

0103
LivaNova
45-09-10
Cable Holding and Organizing System
10
10
10
10
10

0104
LivaNova
49-05-80
Pump Support Caps (6 pieces)
10
10
10
10
10

0105
LivaNova
28-96-40
Control Unit Holder
10
10
10
10
10

0106
LivaNova
43-42-61
Cap for Fast Clamp (6 pcs.)
10
10
10
10
10

0107
LivaNova
000-11-0001
Connection Cable Data Pad II
10
10
10
10
10

0108
LivaNova
97-102-239
Heater Cooler Cable
10
10
10
10
10

0109
LivaNova
97-102-250
Electronic Gas Blender Cable
10
10
10
10
10

0110
LivaNova
49-05-44
Centrifugal Tube Part - Long
10
10
10
10
10

0111
LivaNova
45-12-46
Extension Cable 3m
10
10
10
10
10

0112
LivaNova
45-12-47
Extension Cable 5m
10
10
10
10
10

0113
LivaNova
45-12-57
Medtronic Biotrend 3m Adapter
10
10
10
10
10

0114
LivaNova
45-12-58
Xtra 3m Adapter
10
10
10
10
10

0115
LivaNova
45-12-61
CDI500, CDI550 3m Adapter
10
10
10
10
10

0116
LivaNova
45-12-62
Datamaster Adapter
10
10
10
10
10

0117
LivaNova
45-12-63
Cobe Sat/Crit 3m Adapter
10
10
10
10
10

0118
LivaNova
45-12-65
HP Merlin 3m Adapter
10
10
10
10
10

0119
LivaNova
45-12-66
Datex AS/3 3m Adapter
10
10
10
10
10

0120
LivaNova
45-12-67
Hemochron Signature 3m Adapter
10
10
10
10
10

0121
LivaNova
45-12-68
Medtronic ACT II 3m Adapter
10
10
10
10
10

0122
LivaNova
45-12-69
Philips InterlliVue 3m Adapter
10
10
10
10
10

0123
LivaNova
45-12-70
Somanetics Invos 5100 3m Adapter
10
10
10
10
10

0124
LivaNova
45-12-72
Marquette 8000M, Vamos 3m Adapter
10
10
10
10
10

0125
LivaNova
97-102-268
HC AUX Can Adaptor Cable
10
10
10
10
10

0126
LivaNova
97-102-306
Adaptor Power Cable US
10
10
10
10
10

0127
LivaNova
Clips + Roofs
Clips and Roofs
10
10
10
10
10

0128
LivaNova
49-05-42
Centrifugal Tube Part - Short
10
10
10
10
10

0129
LivaNova
49-05-42
Large Roller Tube Part - Short
10
10
10
10
10

0130
LivaNova
49-05-42
Small Roller Tube Part - Short
10
10
10
10
10

0131
LivaNova
10-07-21
Mechanical Venous Clamp Insert 1/4" x 3/32"
40
40
40
40
40

0132
LivaNova
10-07-22
Mechanical Venous Clamp Insert 3/8" x 1/16"
40
40
40
40
40

0133
LivaNova
10-07-24
Mechanical Venous Clamp Insert 1/2" x 1/16"
40
40
40
40
40

0134
LivaNova
10-07-26
Mechanical Venous Clamp Insert 5/8" x 3/32"
40
40
40
40
40

0135
LivaNova
10-07-27
Mechanical Venous Clamp Insert 1/8" x 1/16"
40
40
40
40
40

0136
LivaNova
10-07-28
Mechanical Venous Clamp Insert 3/16" x 1/16"
40
40
40
40
40

0137
LivaNova
97-102-309
Elongation Power Cable
10
10
10
10
10

0138
LivaNova
45-12-03
Connection Cable, Essenz, Patient Monitor
40
40
40
40
40

0139
LivaNova
28-96-80
Color Knob Rings & Stickers
10
10
10
10
10

0140
LivaNova
050111090
PAS Water FTG RT ANG
10
10
10
10
10

0141
LivaNova
45-12-08
Connection Cable, Essenz, Special Convert
40
40
40
40
40

0142
LivaNova
49-05-70
Cable Clips (6 pieces)
10
10
10
10
10

0143
LivaNova
49-05-22
Hook for Clamps
10
10
10
10
10

0144
LivaNova
97-102-227
Power Cord HLM (USA/Canada)
10
10
10
10
10

0145
LivaNova
97-102-307
Power Cord Perfusion System Monitor
10
10
10
10
10

0146
LivaNova
97-102-302
Power Cord EPM (2m, USA/Canada)
10
10
10
10
10

0147
LivaNova
97-102-303
Power Cord EPM (6m, USA/Canada)
10
10
10
10
10

0148
LivaNova
49-05-71
Cable Clip Roof (3 pieces)
10
10
10
10
10

0149
LivaNova
10-96-10
Tubing Clamp Block 1/8" x 1/16"
10
10
10
10
10

0150
LivaNova
10-96-11
Tubing Clamp Block 3/16" x 1/16"
10
10
10
10
10

0151
LivaNova
10-96-12
Tubing Clamp Block 1/4" x 1/16"
10
10
10
10
10

0152
LivaNova
10-96-13
Tubing Clamp Block 1/4" x 3/32"
10
10
10
10
10

0153
LivaNova
10-96-14
Tubing Clamp Block 5/16" x 1/16"
10
10
10
10
10

0154
LivaNova
10-96-15
Tubing Clamp Block 5/16" x 3/32"
10
10
10
10
10

0155
LivaNova
050114000
Hansen Male-Male Water Fitting Adapter
10
10
10
10
10

0156
LivaNova
28-95-34
Power Pack Blind Cover
10
10
10
10
10

0157
LivaNova
76-102-997
Color Coding Stickers
10
10
10
10
10

0158
LivaNova
75-521-603
Level Sensor Holder
10
10
10
10
10

0159
LivaNova
76-102-996
Cable Flags, WHITE
10
10
10
10
10

The Department of Veterans Affairs (VA) is seeking vendors who can provide LivaNova® Essenz Perfusion System (Heart-Lung Bypass Units) as listed above or equal commodities which meet all the following salient characteristics.

CLIN 0001 applies to the Following SCs:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

Heart-Lung Bypass Units must be designed for cardiopulmonary bypass and/or extracorporeal circulation procedures

Literature Review

SC 2

Heart-Lung Bypass Units must include an uninterruptable power supply (UPS) or back-up battery

Literature Review

SC 3

Heart-Lung Bypass Units must have a user interface

Literature Review

SC 4

Heart-Lung Bypass Units must be modular; allowing various and additional configurations

Literature Review

SC 5

Heart-Lung Bypass Units must monitor and display parameters

Literature Review

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

1. Does vendor offer an annual service plan, Yes or No?

0. If Yes:

0. What does the plan cover?

0. Does plan cover software updates only?

0. Does the plan cover parts repair or replacement only?

0. Does the plan cover both software and parts?

0. Vendor is requested to provide documentation that shows information on their service plan.

0. Is the service provided by the OEM or a subcontractor?

1. Full name and address of company

1. DUNS number/ CAGE Code/ SAM UIE

1. Business Size

1. Manufacturer or Distributor

4. If distributor provide full name, business size and address of manufacturer.

1. Country of Origin designation for all products

1. Ability to provide uninterrupted supply of products on a national scale

1. Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met

1. Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.

*= Required Field

Sources Sought Notice

File details come from the government source that posted it. Updated Dec 11, 2024.