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Sources Sought

The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Business Manufacturers, other Small Businesses interested and capable of providing items requested.

The intended contract is a firm-fixed price contract.

A SBA Non-Manufacturer Rule Waiver will not apply if this requirement is set-aside for small business. It does apply to all other socioeconomic small business categories.

The Department of Veterans Affairs, NCO20 is looking for BRAND NAME or EQUAL sources of the following:

Roche 6800 Reagents and Consumables Base Plus Four.

Salient Characteristics:

Base Plus Four contract for consumables and reagents to support Clinical laboratory molecular testing at VAPORHCS in the microbiology/molecular department, run on VA owned equipment, Roche 6800 instrument.
Salient characteristics:
Automated Viral load monitoring testing system, FDA approved for testing on routine blood collections
SARS-CoV-2 assay capability
FDA approved for assays (quantitative HIV-1, quantitative HCV, quantitative HBV, and quantitative CMV, and HPV)
Inclusion of enzyme designed to minimize chances of contamination or carryover for each test by selective amplification: Catalyzes the destruction of DNA strands containing deoxyuridine19, but not DNA containing deoxythymidine. This way, the contaminating amplicons are susceptible to destruction by the enzyme prior to amplification of the target DNA, reducing possibility of amplicon contamination.
Dedicated consumables to minimize contamination and protect the integrity of samples, UV light and independent reagent and sample pipetting.
High throughput, at least 130 samples per 8-hr shift, at least 31-day reagent stability once testing kit opened.


SOW VAPORHCS Molecular Testing

Statement of Work for Consumables for Molecular Testing

1. Purpose: Requesting the procurement of accessories, reagent kits, consumables, supplies,
and training for HCV, HIV, HBV, CMV, CT/NG, HPV, SARS-CoV-2, SARS-CoV-2/Flu PCR
testing through purchase agreement for the molecular testing section at VA Portland Health
Care System.

2. Scope: The VA has purchased the Roche 6800 equipment and maintenance contract with 4
years of maintenance. VAPORHCS requires a reagent/consumable package. Contract #
CO3V797D-70105 36C2602F0759 will provide instrument and related components including
printers and power supplies, technical and field support, service, and training for HCV, HIV,
HBV, CMV, HPV, CT/NG, and SARS-CoV-2, and SARS-CoV-2/Flu testing. Additional assays
may be added to the test menu as they become available at the discretion of VAPORHCS.
The Contractor shall provide reagents, consumables, and supplies as requested by
VAPORHCS staff.

3. Location: The analyzer is located and testing will be performed in the Microbiology section,
2c-129 Pathology & Laboratory Medicine Service, 3710 SW US Veterans Hospital Rd.
Portland, OR 97239.

4. Performance Requirements: The following are required (note: Roche 6800 has been
purchased, see above executed award and contract):

A. Testing Requirements:
1) Fully automated walk-away system that does not require operator intervention once
test run is started.
2) System is classified for moderately complex testing to allow flexibility in staffing
assignments.
3) System is capable of sampling from primary tube; no aliquoting, pouring, or pipetting is required prior to testing.
4) Reagents and controls are liquid and ready to use; no additional mixing, pouring,
measuring, or aliquoting is required.
5) System has on-board refrigerator for reagent storage.
6) System has on-board inventory and recording of system components.
7) System does not require daily maintenance.
8) System does not require calibration.
9) System accommodates automated (interfaced) reporting through Data Innovations (DI)
to eliminate the need for manual interpretation and manual data entry.
B. System Workflow Requirements:
1) Multiple assays (ex. Viral load, women s health) may be performed concurrently on the system.
2) Multiple assays may be run simultaneously on one plate to conserve resources.
3) System allows a high volume of test and controls on board simultaneously.
4) Priority loading is available.
5) System is able to complete (loading to resulting) high volume tests within an 8-hour
period.
C. Contamination Controls:
1) Reagents contain UNG (uracil-N-glycosylase) to prevent crossover contamination.
2) System does not require bleaching.
3) System contains mechanism to prevent draft contamination.
4) System uses disposable transfer pipettes to prevent crossover contamination.
D. Connectivity Requirements:
1) System is fully interfaced with VistA via Data Innovations.
E. Maintenance:
1) The Contractor shall perform preventive maintenance at intervals specified by the
manufacturer to ensure proper equipment performance. Preventive Maintenance
includes the following:
a) Monthly deliverables shall be received in full.
b) Testing all components for proper test performance. Equipment shall reproduce
results according to manufacturer s specifications.
c) After Preventative Maintenance, the Contractor shall submit a detailed work report
for notice at no additional cost to the government.
d) Delivery of parts or materials for Preventive Maintenance. The Contractor shall
provide all preventive service materials at no additional cost the government.
F. Technical Support:
1) Support Personnel will be available by during business hours each business day, and
live representatives via the Contractor s message center will be available by telephone
at all other times.
2) Technical support shall be available via telephone during business days (and by
message center after hours) to provide troubleshooting assistance or to answer testing
inquiries.
3) On-site technical support shall be available for escalations within 48 hours.
G. On-site Repairs:
1) For issues that the Contractor determines to require on-site support, the Contractor
shall dispatch one or more Support Personnel, normally within 48 business hours after
documentation.
2) The Contractor shall submit a detailed work report to include all required materials.
3) For the delivery of repairs, parts, or materials, the Contractor shall provide all parts and
materials at no additional cost the government.
4) The Contractor shall remove all parts, equipment or materials replaced, or upgraded by
the Contractor due to and not limited to repairs, replacements, recall, and upgrades
without any cost to the government.
H. Training:
1) The Contractor will provide two (2) initial off-site operator training for the Base year and
one off-site operator training for each Option year.
2) The Contractor will conduct additional on-site training as requested by VAPORHCS at
no additional charge.
I. Safety:
1) The Contractor shall immediately notify VAPOHCS of any changes in reagent kit
composition, procedure modification, recall notification, or any changes that will affect
the performance of the test or procedure according to FDA regulations.
J. Test Performance:
1) All tests, procedures, and equipment must perform at manufacturer s specifications.
Deviations from the performance specifications shall be corrected by the Contractor.
2) Test performance will be evaluated by and not limited for performance thru peer
comparison, quality control and CAP peer evaluation.
3) The vendor shall reimburse VAPORHCS for any costs and/or supplies related to tests
sent to a referral laboratory when testing is not available through no fault of the facility
due to reagent problems, other product issues, instrumentation failure, or other
factors. The assessed damages shall be applied to the invoice in the form of a credit
or deduction.

5. Period of Performance: Agreement for the analyzer will be in effect for a contract year, with
options to extend contract for and four (4) additional one (1) year periods.
Base period - Sept 1, 2023 through August 30, 2024
Option 1 - Sept 1, 2024 through August 30, 2025
Option 2 - Sept 1, 2025 through August 30, 2026
Option 3 - Sept 1, 2026 through August 30, 2027
Option 4 - Sept 1, 2027 through August 30, 2028

6. Deliverables and Supplies: Reagents and supplies will be purchased under the terms of this
reagent purchase agreement.
A. The Contractor shall deliver all supplies necessary for test performance at no Government cost.
B. The Contractor shall deliver all and not limited to operational, maintenance,
troubleshooting, small repairs, equipment specifications, and test manuals.
C. The Contractor shall provide supplies: reagents and consumables for the Hepatitis C,
Hepatitis B, HIV Viral Load, CMV, HPV, SARS-CoV-2, SARS-CoV-2/Flu assays. Additional testing may be added at the discretion of VAPORHCS. Any additional testing shall be negotiated between the Contractor and VAPORHCS.
D. In the event that requested supplies are on back-order, Contractor is to provide information as to the estimated time of availability.
E. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle.
F. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.
G. Any changes in reagents or equipment modifications shall be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its
application.

7. Records Management: All records (administrative and program specific) created during the
period of the contract belong to VAPORHCS must be returned to VAPORHCS at the end of
the contract.
8. Quality Assurance Surveillance Plan (QASP): The Contractor shall be evaluated for
Quality, Scheduling, Cost Control, Management, Regulatory, and Customer Satisfaction for
the Base and each Option year. Scoring Criteria and Incentives are outlined below:
Scoring Average score value per category:
Exceptional 4
Very Good 3
Satisfactory 2
Marginal 1
Unsatisfactory
Standard
Task
ID
(CPARS)
Indicator
Acceptable Quality Level
Method of Surveillance
Incentive
Repeat runs are minimal due to reagent or instrument issues.
1.1
Successful reporting of results
No more than 2 instances of repeat runs due to a single reagent or instrument issue per quarter.

Exceptional: 0
Very Good: 1
Satisfactory: 2
Marginal: 3
Unsatisfactory: >3
Troubleshooting records
Service records
Exercise of Option Period
Minimal unsuccessful performance due to instrument or reagent issues.
1.2
Successful peer group comparison
90% satisfactory performance to peer group.

Exceptional: 100%
Very Good: 95-99%
Satisfactory: 90-94%
Marginal: 85-89%
Unsatisfactory: CAP survey reports
Exercise of Option Period
Instrument downtime is minimal.
1.3
Instrument Repairs
90% satisfactory instrument performance annually.

Exceptional: 100%
Very Good: 95-99%
Satisfactory: 90-94%
Marginal: 85-89%
Unsatisfactory: Troubleshooting records
Service Records
Sendout records
TAT reports

Engineer visit within 48 hours of service designation.
Schedules
2.1
Emergency Repairs
90% Visits within 48 hours of service designation.

Exceptional: 100%
Very Good: 95-99%
Satisfactory: 90-94%
Marginal: 85-89%
Unsatisfactory: Troubleshooting records
Service records
Exercise of Option Period
Vendor initiates scheduling of preventive maintenance.
2.2
Proactive Maintenance Service
95% Visits initiated by vendor.

Exceptional: 100%
Very Good: 98-99%
Satisfactory: 95-97%
Marginal: 85-89%
Unsatisfactory: Service records
Problem records

Telephone Support is responsive.
2.3
Trouble-shooting via phone
95% Issues resolved within 3 calls or elevated to service.

Exceptional: 100%
Very Good: 98-99%
Satisfactory: 95-97%
Marginal: 85-89%
Unsatisfactory: Troubleshooting records
Problem records
Service records
Exercise of Option Period
Invoices are submitted monthly.
Cost Control
3.1
Invoice Accountability
100% Invoices received through OLCS via Austin, Texas
Invoice records
Exercise of Option Period
Invoices are itemized by service or product received.
3.2
Invoice Verification
80% Invoices contain all necessary information for proper processing.

Excellent: 95-100%
Very Good: 90-94%
Satisfactory: 85-89%
Marginal: 80-84%
Unsatisfactory: Invoice records
Exercise of Option Period
Backordered reagents and supplies are minimal.
Management

4.1
Backorders

Excellent: 0%
Very Good: 1-2%
Satisfactory: 3-4%
Marginal: 5%
Unsatisfactory: >5%
Order records
Invoice records
Customer communications
Exercise of Option Period
Provides timely follow-up for backorders.
Regulatory
6.1
Backorder Notification
90% timely follow up for backorders

Exceptional: 100%
Very Good: 95-99%
Satisfactory: 90-94%
Marginal: 85-89%
Unsatisfactory: Order records
Invoice records
Customer communications
Exercise of Option Period
Contractor will provide proactive notification of changes.
6.2
Notification of changes in reagent and equipment modifications
100% Proactive notifications.

Quality Bulletins
Customer Letters
Customer Contact
Exercise of Option Period
Timely recall notification of reagent and supplies.
6.3
Recall Notification
100% Recall notifications within 1 month of issuance.
Quality Bulletins
Customer Letters
Customer Contact
Exercise of Option Period
Works with customer to resolve complaints.
Customer Satisfaction
7.1
Substantiated complaints
No unresolved substantiated customer complaints per year
Order records
Invoice records
Customer communications
Problem records
Troubleshooting records
Exercise of Option Period
Timely follow-up on complaints.
7.2
Complaint Handling
90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe.

Exceptional: 100%
Very Good: 95-99%
Satisfactory: 90-94%
Marginal: 85-89%
Unsatisfactory:
Order records
Invoice records
Customer communications
Problem records
Troubleshooting records
Exercise of Option Period
NARA RM Language Clause to be included in contracts, as necessary:
1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31
and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR
Part 1222 and Part 1228.
2. Contractor shall treat all deliverables under the contract as the property of the U.S.
Government for which the Government Agency shall have unlimited rights to use, dispose
of, or disclose such data contained therein as it determines to be in the public interest.
3. Contractor shall not create or maintain any records that are not specifically tied to or
authorized by the contract using Government IT equipment and/or Government records.
4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains
information covered by the Privacy Act of 1974 or that which is generally protected by the
Freedom of Information Act.
5. Contractor shall not create or maintain any records containing any Government Agency
records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.
6. The Government Agency owns the rights to all data/records produced as part of this
contract.
7. The Government Agency owns the rights to all electronic information (electronic data,
electronic information systems, electronic databases, etc.) and all supporting
documentation created as part of this contract. Contractor must deliver sufficient technical
documentation with all data deliverables to permit the agency to use the data.
8. Contractor agrees to comply with Federal and Agency records management policies,
including those policies associated with the safeguarding of records covered by the Privacy
Act of 1974. These policies include the preservation of all records created or received
regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or
state of completion [draft, final, etc.].
9. No disposition of documents will be allowed without the prior written consent of the
Contracting Officer. The Agency and its Contractors are responsible for preventing the
alienation or unauthorized destruction of records, including all forms of mutilation. Willful
and unlawful destruction, damage or alienation of Federal records is subject to the fines
and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal
custody of the Agency or destroyed without regard to the provisions of the agency records
schedules.
10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual
relationship (sub-Contractor) in support of this contract requiring the disclosure
of information, documentary material and/or records generated under or relating to this
contract. The Contractor (and any sub-Contractor) is required to abide by Government and
Agency guidance for protecting sensitive and proprietary information.
References:
VHA Directive 6300
VA Handbook 6300.1
VA Directive 6500

36 CFR Part 1222.32 (b)
Potential contractors shall provide, at a minimum, the following information to kevin.brown1@va.gov.

1) Company name, address, and point of contact, phone number, e-mail address, and DUNS.

2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 325413 In Vitro Diagnostics Substance Manufacturing. To be considered a small business your company must have fewer than 1,250 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following:
[ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB)
[ ] yes [ ] no Veteran Owned Small Business (VOSB)
[ ] yes [ ] no Small Business Manufacturers
[ ] yes [ ] no All other Small Business (SB)
[ ] yes [ ] no Other than Small Business

3) The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM).

4) Any Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov.

5) Only authorized representatives/providers of the manufacturer will be considered. Equipment must be new, no used or refurbished equipment accepted. Please provide a proof of authorized dealer or reseller letter from manufacturer.

6) This is a brand name or equal requirement. As such, the salient characteristics reflect the physical, functional, or performance characteristics that equal products must meet to satisfy the Government s needs. To be considered for any potential solicitation, offers of equal products, including equal products of the brand name manufacturer, must:

(a) Meet the salient physical, functional, or performance characteristic specified in this sources sought; clearly identify the item by Brand name, if any and make/model number.

(b) Include descriptive literature such as illustrations, drawings, or a clear reference to descriptive data or information available that identifies that the equal item meets or exceeds the salient characteristics required by the Government.

Responses are due by 05/31/2023 08:00 am PST, to the Point of Contact.

Shipping Address:
Portland VA Healthcare System
3710 SW US Veterans Hospital Rd
Portland, OR 97239

Point of Contact:
Kevin Brown
Contract Specialist
Kevin.Brown1@va.gov
(360)553-7674

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