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The Central Texas VA Health Care System (CTVAHCS) is seeking Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or Small Business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12.

NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE.

The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or Small Business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance, and delivery information by notifying the Contract Specialist no later than 4:00 PM Central Time, October 26, 2022. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov. Phone calls will not be accepted.

Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope.

DISCLAIMER

This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice.

STATEMENT OF WORK

GENERAL INFORMATION

1. Title of Project: Coagulation Analyzer CPRR

2. Purpose: The intent of the Central Veterans Affairs Health Care System (CTVHCS) Pathology & Laboratory Medicine Service (PLMS) is to provide continuous, accurate, coagulation testing to providers. The desired proposal requires reagents, quality control materials, and consumables to be provided for approximately 21,550 coagulation tests analyzed annually on a cost-per-test (CPT) or cost per reportable result (CPRR) basis as an IDIQ for four (4) identical automated analyzers for the following locations:

2.1. Two (2) identical automated analyzers for:
Central Texas VA Health Care System (CTVHCS) (674)
Olin E. Teague Medical Center
1901 Veterans Memorial Dr.
Temple, TX 76504
Attn: Hematology Building 163 RM 1D102

2.2. One (1) analyzer to be identical to the two (2) automated analyzers in Temple.
Central Texas VA Healthcare System (CTVHCS) (674-BY)
Austin Outpatient Clinic (AOPC)
7901 Metropolis Dr.
Austin, TX 78744
Attn: Pathology and Laboratory Medicine Service (PLMS)
Building 7901 RM 2B105

2.3 One (1) analyzer to be identical to the two (2) automated analyzers in Temple.
Central Texas VA Healthcare System (CTVHCS) (674-A4)
Doris Miller VA Medical Center
4800 Memorial Dr.
Waco, TX 76711
Attn: Pathology and Laboratory Medicine Service (PLMS)
Building 4W RM 1A157J1
3. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Vendor shall provide a total four (4) coagulation analyzer with the following test menu: PT, PTT, and Fibrinogen, Thrombin Time and Anti-Xa LMWH/ Anti-Xa UFH. All equipment, reagents and service shall be provided on a Cost-Per Test basis. There will be three locations for the CPT: Temple, Austin and Waco, Texas VA Medical Centers. All necessary supplies, software, reagents, and QC program. Service warranty Monday through Friday to include all travel, labor and replacement parts included. Preventative maintenance shall be every 6 months included in the service warranty agreement. All necessary supplies will be delivered inside the lab to each site at no additional cost. Ability to perform PT/INR, PTT, D-Dimer, Fibrinogen, Thrombin Time and Anti Xa Testing at location 674. Ability to perform PT/INR testing at locations 674A4 and 674BY.
A. Analyzer requirements:
Analyzers must have cap piercing technology.
Must have the ability to handle multiple sized tubes such as microtainers / 12 x 75mm tubes, etc.
Must have the ability to level sense reagents and samples to prevent short sampling errors.
Ability to prioritize STAT testing without compromising existing programmed testing.
Minimal daily, monthly, and periodic maintenance.
The ability to store and retransmit records in case of interface outage.
The ability to handle hemolysis, icteric or lipemic specimens.
The ability to provide continuous sample and reagent loading.
Throughput must provide at minimum 100 tests/hr for PT/PTT.
Must have an on-board QC data management system with a minimum storage capacity of 2 years of QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.
QC program must be configurable with multiple rules.
Must have an auto stop or lock out features built in for QC failures.
Ability to perform and program automatic QC testing QC testing can be performed automatically according to user-defined time intervals and user defined test intervals or at reagent changes.
A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.
Equipment must be able to support multiple barcode formats (Code 39, Cod 128) that may be enabled concurrently.
Equipment must accept, at a minimum, BARC characters in specimen identification that is alphanumeric.
All peripherals to include keyboard, mouse, monitors, and printers will be provided by the vendor.
System must have the capability of waste to be plumbed into wastewater system.
Analyzer must be able to sit in a 2-foot-deep x 4-foot-wide space.
Reagent requirements:

Vendor shall provide quality control material at a minimum of two levels for each test platform: normal and elevated/abnormal levels.
All reagents, controls, calibrators, and normal donor plasma (for annual lot changes) will be of the same lot number for all users. Lot numbers will be in use at least twelve (12) months. All sites will convert to the new yearly lot number within 2 months of each other.
24-hour QC.
Liquid reagents are preferred.
Vendor must Install instrumentation and provide documentation certifying the instrumentation after installation.
Training:
Vendor will provide training to staff after initial setup and provide go-live support.
Additional training will be provided annually for each instrument / year at no additional cost to the VA.
Technical Support and Service:
Vendor will provide Technical Support. Phone support will be provided 24/7 for all sites. Onsite support M-F 8am 5pm except when both instruments are down for site 674.
Onsite service will be provided no later than 24 hours after the need was reported to the Vendor.
The vendor will set and adhere to a preventative maintenance schedule.
Documentation of all visits will be provided to the supervisor / lab manager at each site.
Vendor will provide reagents, disposables, controls, and service for the instrument
The vendor will provide assistance and guidance for lot validation studies and heparin therapeutic studies for initial and follow-on support after initial validation studies.
Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.
Characterization of waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is a hazardous waste or otherwise regulated.
4. Performance Period: The contractor shall complete the work required under this SOW in 60 calendar days or less from date of award, unless otherwise directed by the Contracting Officer (CO). This shall be for a base year contract from 7/1/2023-6/30/2024. Four option years from 7/1/2024-6/30/2028.

5. Type of Contract: This is a firm fixed-price contract.

B. GENERAL REQUIREMENTS

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.
Instrumentation shall be from the same family of analyzers as applicable and suitable for the facilities listed.

The equipment models being offered shall be in current production as of the date this proposal is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Consideration of used equipment or current in-house equipment will not be accepted in the proposal.

The Vendor shall provide all upgrades to the equipment hardware and operating system software at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market.

All components instrumentation, middleware, and reagents shall be compatible with each other. All components shall be manufactured with the purposeful intent of being utilized operationally with each other.

All components instrumentation, middleware, and reagents shall be Food and Drug Administration (FDA)-approved.

Instrumentation and reagents shall be able to perform tests to specifications as defined by CLIA and CLSI standards, including satisfactory CAP peer group comparisons.

Sufficient capacity and throughput to meet the volume and service demands as defined. To be configurable to perform automatic on-board dilutions of all samples with out-of-range results or defined limits are exceeded.

Capability to program a test as a repeat with interfacing of results to overlay initial result.

The ability to continuously load patient specimens. Be an open system which can accommodate at least 5 or more user-defined assays with the ability of incorporating other manufacturer s reagents

The ability to detect short samples and have clot detection with alert notification prior to the sample entering the probes.

Capable of primary tube sampling from various manufacturers and sizes of evacuated tubes.

Accepts citrated plasma for patient testing only.
Ability to handle all routine sample collection tubes plus other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.

Proven to have zero to minimal patient sample carryover.

Proven to have zero to minimal interfering factors that would affect the test results (such as hemolysis, lipemia, icterus, drug interference, etc.)

Can quantify, at least semi-quantitatively, plasma indices. This includes hemolysis, icterus, and lipemia. Indices should be reported as 1+ to 4+ and have respective bias information corresponding to this interference in the assay package inserts.

Ability to prioritize STAT testing without compromising existing programmed testing.

Minimal operator intervention to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run.

Be able to have calibration testing and quality control testing performed without excess delay to testing currently in progress.

The instrument systems shall have on-board reagent refrigeration as required.

The instrument systems shall have on-board, adjustable, color, touchscreen monitors that are easily readable and icon driven and user friendly.

The Vendor shall provide all necessary printers for the instrument systems and shall be responsible to replace/repair any broken instrument system printers over the life of the contract. (Supplies such as paper, cartridges/ink will be the responsibility of the Government)

The Vendor shall provide all upgrades to the equipment hardware and operating system software at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market.

As required, all required water systems, primary and backup, to supply deionized water for coagulation analyzers (filters, preventative maintenance, and repair) is the responsibility of the Vendor.

Safety features to avoid unnecessary exposure to biohazardous and chemical material.

Total equipment footprint when installed in the laboratory shall not impact the functionality/operations of laboratory.





C. TASKS, DELIVERABLES/SUPPLIES

1. Four Coagulation Analyzer
2. Cost Per Test Reagents in the quantities listed below: SEE ATTACHMENT A
3.Support to include:

One training slot per year
Mobile learning
Service/Maintenance: Monday - Friday

D. PERFORMANCE REQUIREMENTS

Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

Inventory and recording of systems components.
Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications.
After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.
Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

Repairs and support

Technical support: Support Personnel will be available by telephone from 0800 to 1700 each business day.
On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.
For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.
Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government.

Training: The contractor will provide one operator training slot per year and mobile learning opportunities.

Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor.

All test performance will be evaluated by and not limited for performance thru peer comparison, quality control, and CAP peer evaluation.

E. TRAINING REQUIREMENTS

The Vendor must provide an instrument(s) training program that is coordinated with and timely to the equipment installation.

Initial training to include one (1) operator per analyzer(s) and will include training on the operation of the system, data manipulation, and basic troubleshooting and repair.

Utilization of the training slots will be mutually agreed upon between the Amarillo VAHCS and Lubbock CBOC and the Vendor.

Additionally, the Amarillo VAHCS and Lubbock CBOC is requesting four (4) training slots specific to the middleware solution offered in the proposal either to be on-site or off-site.

A training program that involves off-site travel shall include the cost of airfare, ground transportation, room and board, and training/classroom costs for each participant.

The Contractor shall also provide in-house training for all laboratory shifts during implementation.

F. BILLING AND INVOICES

Monthly billing and test report summaries shall begin on the first day of the month and
include the last day of the month.
VA-FSC shall require the following information in compliance with the Prompt Pay Act and Business Requirements.

2.1 Your Taxpayer ID number (TIN)

2.2 Your Remit Address information

2.3 The VA Purchase Order (PO) number

2.4 Your contact information: (Personal name, Email, and Phone)

2.5 Your VA Point of contact information (Personal name, Email, and Phone)

2.6 The Period of Performance dates (POP Beginning and Ending)

2.7 All discount information if applicable (Percent and Date Terms)

2.8 Reagents used with pricing per unit

No freight charges to be added to the invoice

Department of Veterans Affairs Financial Service Center:

3.1 Phone:1-877-353-9791

3.2 Email: vafscched@va.gov

CTVHCS shall not be responsible for payment of services and or supplies which were not requested Accordance with the contract.

CTVHCS will NOT pay for tests that are not clearly identified by product number on the invoice.

Invoices are to be separate for Temple, Waco, and Austin laboratories but the usage of the same PO number is acceptable for billing purposes.

Invoices will be electronically submitted to the Tungsten website at:

7.1 http://ww.tungsten-network.com/uk/en/

7.2 Tungsten direct vendor support number is 877-489-6135 for VA contracts.

All invoices submitted through Tungsten to VA-FSC should mirror your current submission of invoice.

G. SUPPORT FEATURES

Start-Up Reagents. The Vendor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item required to establish instruments for acceptable operation.

The Vendor shall perform/assist with all validation studies listed below at no cost to the government.

2.1 Correlation studies for each analyte

2.2 Linearity or Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range.

2.3 The validation of the INR will meet the pharmacy needs of a minimum of 10 and
above.

2.4 Precision study using normal and abnormal control material. Intra-VISN facility
variations should be kept at an absolute minimum.

2.5 Sensitivity/Specificity: efficiency, sensitivity, false positive rate, and false negative rate.

2.6 Carryover Studies.

2.7 Reference Range- Reference range assessment must be performed for each lab.

2.8 Accuracy/Recovery

2.9 Calibration Verification

Method performance/comparison shall be consistent with current CLSI guidelines, College of American Pathologists (CAP) standards and Federal regulations.

All studies performed will be appropriate for the test menu of the respective laboratory to include citrated plasma.
H. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

I. CONTRACTOR SECURITY REQUIREMENTS

This contractor requires no access to CTVHCS or any VA information system. The analyzer will be interfaced to the CTVHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

The C&A requirements do not apply. A Security Accreditation Package is not required.

J. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract.


Attachment A:
Base Year:

CLIN No.
Description
Qty.
Unit
Cost*
Total Annual Cost
0001
Coagulation Analyzer for location: 674
2
EA
$0.00
$0.00
0002
Coagulation Analyzer for location: 674A4
1
EA
$0.00
$0.00
0003
Coagulation Analyzer for Location: 674BY
1
EA
$0.00
$0.00
0004
PT / INR
15000
YR
0005
PTT
5500
YR
0006
DDimer
800
YR
0007
Fibrinogen
100
YR
0008
Thrombin Time
100
YR
0009
Anti Xa LMWH / Anti Xa UFH
50
YR
0010
Associated supplies estimated total added to CPRR unit costs
1
YR

$0.00
Option Year 1:

CLIN No.
Description
Qty.
Unit
Cost*
Total Annual Cost
0001
Coagulation Analyzer for location: 674
2
EA
$0.00
$0.00
0002
Coagulation Analyzer for location: 674A4
1
EA
$0.00
$0.00
0003
Coagulation Analyzer for Location: 674BY
1
EA
$0.00
$0.00
0004
PT / INR
15000
YR
0005
PTT
5500
YR
0006
DDimer
800
YR
0007
Fibrinogen
100
YR
0008
Thrombin Time
100
YR
0009
Anti Xa LMWH / Anti Xa UFH
50
YR
0010
Associated supplies estimated total added to CPRR unit costs
1
YR

$0.00

Option Year 2:

CLIN No.
Description
Qty.
Unit
Cost*
Total Annual Cost
0001
Coagulation Analyzer for location: 674
2
EA
$0.00
$0.00
0002
Coagulation Analyzer for location: 674A4
1
EA
$0.00
$0.00
0003
Coagulation Analyzer for Location: 674BY
1
EA
$0.00
$0.00
0004
PT / INR
15000
YR
0005
PTT
5500
YR
0006
DDimer
800
YR
0007
Fibrinogen
100
YR
0008
Thrombin Time
100
YR
0009
Anti Xa LMWH / Anti Xa UFH
50
YR
0010
Associated supplies estimated total added to CPRR unit costs
1
YR

$0.00
Option Year 3:

CLIN No.
Description
Qty.
Unit
Cost*
Total Annual Cost
0001
Coagulation Analyzer for location: 674
2
EA
$0.00
$0.00
0002
Coagulation Analyzer for location: 674A4
1
EA
$0.00
$0.00
0003
Coagulation Analyzer for Location: 674BY
1
EA
$0.00
$0.00
0004
PT / INR
15000
YR
0005
PTT
5500
YR
0006
DDimer
800
YR
0007
Fibrinogen
100
YR
0008
Thrombin Time
100
YR
0009
Anti Xa LMWH / Anti Xa UFH
50
YR
0010
Associated supplies estimated total added to CPRR unit costs
1
YR

$0.00
Option Year 4:

CLIN No.
Description
Qty.
Unit
Cost*
Total Annual Cost
0001
Coagulation Analyzer for location: 674
2
EA
$0.00
$0.00
0002
Coagulation Analyzer for location: 674A4
1
EA
$0.00
$0.00
0003
Coagulation Analyzer for Location: 674BY
1
EA
$0.00
$0.00
0004
PT / INR
15000
YR
0005
PTT
5500
YR
0006
DDimer
800
YR
0007
Fibrinogen
100
YR
0008
Thrombin Time
100
YR
0009
Anti Xa LMWH / Anti Xa UFH
50
YR
0010
Associated supplies estimated total added to CPRR unit costs
1
YR

$0.00

Attachments/Links