RFQ doc.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C26224Q1440

Carlos Magana (562)766-2272

36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

X

325413

1,250 Employees

N/A

36C262

Department of Veterans Affairs

VISN 22

See Section B-Paragraph B.2.6

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600

Financial Services Center

See CONTINUATION Page

See CONTINUATION Page

36C26223Q1359

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

B.2 DESCRIPTION OF AGREEMENT

B.3 PRICING

B.4 OBLIGATION OF FUNDS

B.5 PERIOD OF PERFORMANCE

B.6 ORDER FORMAT

B.7 AUTHORIZED REPRESENTATIVES

B.8 FEDERAL HOLIDAYS

B.9 PRECEDENCE

STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 35

C.4 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.5 52.225-5 TRADE AGREEMENTS (NOV 2023) ………………………….………

C.6 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)……………………..38

C.7 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

C.11 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

E.5 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

SECTION B – GENERAL TERMS

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

1. BPA ADMINISTRATION: All BPA administration matters will be handled by the following individuals:

a. CONTRACTOR:

[Company Contact Person’s Name]:

[Company]:

[Street Address]:

[City, State, Zip]:

[Phone number]:

[Email address]:

[CAGE Number]:

[SAM Number]:

b. GOVERNMENT:

Contracting Officer (CO): Kevin Ceponis

Department of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600

Kevin.Ceponis@va.gov

Contracting Officer (CO): Carlos Magana

Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600

Carlos.Magana@va.gov

2. OFFEROR REMITTANCE ADDRESS: See Section B.2.6 for details.

3. ACKNOWLEDGMENT OF AMENDMENTS: The Contractor acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NUMBER DATE

B.2 DESCRIPTION OF AGREEMENT

1. INTENT: In the spirit of the Federal Acquisition Streamlining Act and pursuant to Federal Acquisition Regulation (FAR) Part 12, Part 13 and Part 16, the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22 Healthcare Centers is establishing this single award Blanket Purchase Agreement (BPA) contract for Polymerase Chain Reaction (PCR) Diagnostics for Pathogens System as described within this solicitation. The Contractor shall make available for purchase all the necessary products and services commercially available by Contractor to meet VISN 22 Healthcare

Center's needs as outlined within this BPA. VISN 22 Healthcare Centers require the following: 1) A complete solution from a single Contractor to avoid problems with equipment interface, warranties, validations, and multiple points of contact for the solution, plus it streamlines workflow and enhances patient care outcomes; 2) Rapid testing is required by the VA to meet its mission for the best patient care to our veteran population;

3) The solution must be FDA approved to reduce the VA manhours for lengthy comprehensive validation processes of lab developed tests, to reduce the high complexity level of VA staff required in the laboratory, and to reduce the need of hiring additional staffing levels required to carry out non-FDA approved systems and testing. In addition, as requirements change, products and services may be added or deleted by supplemental agreement of the Government and the Contractor. Prices in this schedule represent an all-inclusive rate including labor, incidental costs, overhead, processing fee, delivery fee, handling fee, insurance premium payments for applicable insurance coverage, etc. Costs not incorporated into the contractor's price will not be reimbursed by the Government.

2. TERM OF AGREEMENT: This BPA shall be a base year plus two (2) optional years which will be reviewed, at least, annually In Accordance With (IAW) FAR Part 13.303-6 to ensure the BPA terms are met, to assess current market conditions and to determine price reasonableness. Additional discounts maybe requested by VISN 22 at any time. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer (CO), this BPA may be canceled with a thirty (30) day written notice to the Contractor by the CO.

3. BPA LIMITS: The estimated BPA time is approximate One Base year and two option years from the effective date of the BPA. Pricing must be established based on the estimated user quantities listed in Attachment A; therefore, the overall BPA total estimate may be revised via supplemental agreement between the Contractor and the VA to accommodate the Government needs.

4. BPA ORDERS: This BPA is a pricing agreement and does not obligate any funds. The Government is obligated only to the extent of authorized BPA Delivery Orders (DO) issued under the BPA by authorized individuals. DO’s shall be identified by the BPA Number (TBD) and DO Number (TBD). DO’s may include option years, if it is determined that option years would be in the best interest of the Government. Any DO issued during the effective term of this BPA shall be completed by the Contractor within the time specified in the DO, including all option years, which may extend beyond the BPA term. The Contractor shall accept the price, terms and conditions of an issued DO as long as they do not conflict with the terms set forth in the BPA. DO’s shall be limited to $ (TBD) per order.

5. ORDERING METHOD: All orders shall be placed against valid DO’s signed by the CO.

The CO shall designate primary facility Point Of Contacts (POC’s), as necessary, which may coordinate delivery and schedule via Electronic Data Interchange (EDI), telephone, facsimile, email or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

BASE PERIOD 10-01-2024 – 09-31-2025 OBLIGATION NUMBER: TBD

OPTION PERIOD 1 10-01-2025 – 09-31-2026 OBLIGATION NUMBER: TBD

OPTION PERIOD 2 10-01-2026 – 09-31-2027 OBLIGATION NUMBER: TBD

6. PARTICIPATING FACILITIES:

Future facilities that fall under the authority of this office, Network Contracting Office 22 (NCO 22), may be added or deleted to this agreement with an exercise of a supplemental agreement between the Government and the Contractor.

Below is a list of participating facilities.

7. BPA PROGRAM MANAGER: The Contractor shall provide a primary BPA program manager who shall be responsible for the performance of the work under the BPA. In addition, the program manager shall act as the main focal point of communication between the CO and the Contractor. The name of this person shall be designated in writing to the CO. The program manager shall have full authority to act on behalf of the Contractor on all contractual/BPA matters relating to daily operation of the BPA.

Contact Name:

Contact Title:

Address:

Direct Phone No:

Alt. Phone No:

VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, CA 90073 310-478-3711

VA Loma Linda Healthcare System

(VALLHS)

11201 Benton Street Loma Linda, CA 92357 909-825-7084

VA Long Beach Healthcare System

(VALBHS)

5901 E. 7th Street Long Beach, CA 90822 562-826-8000

New Mexico VA Healthcare System 1501 San Pedro SE Albuquerque, NM 87108 505-265-1711

Phoenix VA Healthcare System 650 E. Indian School Road Phoenix, AZ 85012 602-277-5551

VA San Diego Healthcare System 3350 La Jolla Village Dr.

San Diego, CA 92161 858-552-8585

Southern Arizona Healthcare System 3601 S. 6th Ave.

Tucson, AZ 85723 520-792-1450

Fax No:

Email:

8. ORDERING CONTACTS: The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders. Additional tables may be inserted, if needed.

9. DELIVERY: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in Section B.2.6, Participating Facilities. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The primary facility POC shall be required to notify the Contractor when delivery locations have been changed.

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain:

Contractor name, BPA number, DO number, VA obligation number, date of order, date of delivery, itemized list of products furnished, including product description and quantity shipped.

All deliveries shall be made during normal working hours from 8:00a.m. to 4:00p.m, local time unless specified otherwise. Standard orders shall be delivered within no more than four (4) working days after receipt or placement of order. Emergency deliveries may be necessary on rare occasions and may occur outside of working hours from 4:00 p.m. to 8:00 a.m. Under emergency occurrences, the Contractor shall deliver to the Government site in the most expeditious manner possible. Without additional cost to the Government, unless expedited shipping/delivery is approved by the primary facility POC, CO or another authorized individual. The Contractor shall provide an emergency point of contact, if different from the standard points of contacts.

No product substitutions shall be made by Contractor without prior approval of the treating facilities primary Point of Contact. However, if substitution would further obligate the government, the Contractor shall have approval of a warranted Contracting Officer.

10. PACKAGING: All supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

11. INVOICE AND PAYMENT: An itemized invoice shall be submitted at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. These invoices need not be supported by copies of delivery tickets. Invoices shall be submitted to WWW.TUNGSTEN- NETWORK.COM in accordance with FAR Part 52.232-34, Payment by Electronic Funds Transfer and VAAR Part 852.232-72.

The following information shall be listed on all invoices submitted: (failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor)

a. Facility’s Name and address where service was provided

b. BPA Number: TBD

c. Purchase Order Number (For Example: 36C26218N0123)

d. Obligation Number (For Example: 600-C87001)

e. Itemized list of products provided, to include quantity, unit price and extended price

f. Include the period of time that is being invoiced for in the invoice

g. BPA Holder’s Internal Contract number (if applicable)

h. Contractor company name, address, and phone number including a POC for concerns and questions. Invoices shall name a specific person, the phone number and email.

In the event of an inconsistency between the terms and conditions of this BPA and the

Contractor's invoice, the terms and conditions of this BPA will take precedence.

B.3 PRICING

Contract Supplies as listed below, with associated pricing, can be ordered under this BPA.

The Contractor shall be allowed to vary within the categories for successful and efficient task completion not to exceed funded values of each order awarded under this agreement. As proposed, the Contractor will apply applicable extended/tier pricing to all categories used in the performance of orders issued under this Agreement. Orders may be awarded on a basis only.

All Calls/Orders placed against this BPA are subject to the terms and conditions of the referenced BPA, the Contractor's proposal and this Agreement, except where noted below.

Contractor's proposal dated is hereby referenced.

B.4 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.5 PERIOD OF PERFORMANCE

This BPA expires on 09/31/2027 or such later ending date as determined by the exercise of any option.

B.6 ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Order will describe the tasks, services and deliverables required.

B.7 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

Contracting Officer (CO): Kevin Ceponis

Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600 Long Beach CA 90815 Kevin.Ceponis@va.gov

Contracting Officer (CO): Carlos Magana

Department of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600

Carlos.Magana@va.gov

B.8 FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.

New Year’s Day Labor Day Birthday of Martin Luther King, Jr. Columbus Day Washington’s Birthday Veterans' Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

B.9 PRECEDENCE

The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.

STATEMENT OF WORK

1. BPA LANGUAGE

1.1. INTENT: Pursuant to Federal Acquisition Streamlining Act and pursuant to Federal Acquisition Regulation (FAR) Part 12 and FAR Part 13.303, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 22 ) to establish a Blanket Purchase Agreement (BPA) for Instrument for Polymerase Chain Reaction (PCR) Diagnostics for Pathogens System. The BPA shall be under Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award both a CPT and CPRR BPA to a single Contractor for Instrument for Rapid Automated Multiplex PCR Diagnostics for Pathogens.

Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment and awarded in the final BPA. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base contract.

1.2. ORDERS: All products ordered under this BPA are subject to the terms and conditions of the base contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

1.3. PRICES AND TERMS: VISN 22 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. Additional items may be added to this BPA that are related to the use of Polymerase Chain Reaction (PCR) Diagnostics for Pathogens System.

1.4. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one (1) base year and up to two (2), (1) one-year options and shall be effective for the term of the Contract including additional extensions. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 22 intends to establish the base year of the agreement for the period of TBD. Within the duration of this BPA, each facility may place orders within the ordering base and exercised options period of the BPA.

1.4.1. Base Period: target date 10/01/2024.

1.4.2. Overall cost with Options: (TBD upon award)

1.5. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation shall be provided at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

1.6. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable Delivery Order Number and BPA Number. DO & BPA identification numbers are assigned through the VHA Procurement Activity; TBD.

1.7. ORDERING METHOD: The participating facilities may order reagents via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the reagents by number, quantity, purchase price, address for delivery, and any special instructions. The vendor shall provide the ability to ship reagents monthly to the participating facilities. The vendor shall provide the ability to ship reagents on an “as needed” basis to the participating facilities.

1.7.1. Delivery Orders issued shall be identified by BPA Number ________ (TBD upon award). Delivery Orders shall be fulfilled within 30 days of receipt of order.

1.8. Participating Facilities: (Additional Facilities within VISN 22 may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor. Line items within the schedule should reflect the overall volume of all sites below and should take into consideration the potential addition of future facilities within VISN 22:

1.8.1. VA Greater Los Angeles Healthcare System | 11301 Wilshire Blvd, Los Angeles, CA 90073

1.8.2. VA Loma Linda Healthcare System | 11201 Benton Street Loma Linda, CA 92357

1.8.3. VA San Diego Healthcare System | 3350 La Jolla Village Dr, San Diego, CA 92161

1.8.4. VA Long Beach Healthcare System | 5901 E. 7th Street, Long Beach, CA 90822

1.8.5. VA Phoenix Healthcare System | 650 E Indian School Rd, Phoenix, AZ 85012

1.8.6. VA Tucson Healthcare System | 3601 S 6th Ave, Tucson, AZ 85723

1.8.7. VA Albuquerque Healthcare System | 1501 San Pedro Dr SE, Albuquerque, NM 87108

1.9. VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this BPA that are related to the use of Polymerase Chain Reaction (PCR) Diagnostics for Pathogens System. All attachments are hereby incorporated into this document as a part of the document itself, however this document shall supersede any conflicts of terms and conditions present.

1.10. Schedule of Supplies and Services - Completed Attachment A shall serve as the Schedule of Supplies and Services. All attachments identified in the table of contents shall be incorporated as a part of this contract document.

1.10.1. Cost Per Test in this BPA is defined as – Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services and installation.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to simultaneously perform the testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2.1.2. Instrumentation will be acquired at each of the Veterans Integrated Service Network (VISN) 22 clinical laboratories located at the following Veterans Affairs (VA) government facilities: see section 1.8.

2.1.3. If Contractor offers a family of analyzers, VISN 22 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

2.1.4. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers.

Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

2.1.5. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2.1.6. Equipment: All equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for each of the stations located at the following VISN 22 facilities: See section 1.8 and Attachment A

2.1.7. Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Polymerase Chain Reaction (PCR) Diagnostics for Pathogens System, supplies and related services.

2.2. DEFINITIONS:

2.2.1. Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering: (1) three year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

2.2.2. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

2.2.3. Contractor Middleware System – Generally a separate component/ computer that electronically links the testing instrumentation to manage data, results and workflow. (Not to be confused with Data Innovations or Dawning).

2.2.4. Throughput – The speed that the equipment processes and/or operates reported in units per hour.

2.2.5. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes.

2.2.6. PRICING: See Attachment A.

2.3. GENERAL REQUIREMENTS:

2.3.1. Primary analyzer(s)– Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

2.3.2. The instrument must have capabilities of identifying organisms directly from specimens including positive blood cultures, synovial fluid, spinal fluid, stool, upper and lower respiratory tract within 1 hour.

2.3.3. The instrument must include an FDA-approved broad library of bacteria, yeast, parasites, and viruses.

2.3.4. The system must include the ability to detect antimicrobial resistance genes. The instrument must be FDA 21 CFR Part 11 Compliant.

2.3.5. A preparatory apparatus and equipment must be provided for specimen preparation.

2.3.6. The platform must have minimal hands-on time (5 minutes or less) without batching.

2.3.7. The instrument must perform amplification, detection, and analysis in one self-contained system.

2.3.8. Reagents – The vendor shall ensure the following:

2.3.8.1. Reagents will be ordered on as needed basis

2.3.8.2. All of the reagents shall be prepackaged and ready for use

2.3.8.3. These items shall be of the highest quality, sensitivity and tested to assure precision and accuracy.

2.3.8.4. Expiration dates must be clearly marked on all reagent containers and no shorter than 12 months out.

2.3.8.5. The vendor shall state the open date stability for all reagents and kits.

2.3.8.6. The vendor shall notify the facility of the expected shipment date of reagents.

2.3.8.7. The vendor shall pay all shipping and handling fees for supplies.

2.3.8.8. The vendor shall package reagents in such a manner as to ensure the integrity of the reagents, kits and supplies during transport.

2.3.8.9. The vendor shall explain their policy on replacement of unsuitable or damaged products or reagents/kits shipped in error.

2.3.8.10. The vendor shall supply all Safety Data Sheets for their proposed reagents.

2.3.8.11. The vendor shall inform the participating facilities of any reagent recalls or bulletins due to product unavailability due to manufacturing issues.

2.3.8.12. Alert/Notifications of any delays in shipment as well as all technical advisory/recalls, prior to or simultaneously with field alerts should be forwarded to the participating facilities.

2.3.8.13. The vendor shall provide their plan for product availability if reagents become scarce or unavailable.

2.3.8.14. The vendor shall provide an acceptable itemized bill for all items shipped for payment with each shipment.

2.3.9. Operational Features- The instrumentation offered shall have the following:

2.3.9.1. The capability of performing analysis on 100% of the tests listed in Attachment A.

2.3.9.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

2.3.9.3. 24 hours of maximal instrument throughput.

2.3.9.4. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal and require a minimum amount of handling.

2.3.9.5. The accuracy of the barcode reading must have less than a 1.0% failure rate.

2.3.9.6. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2.3.9.7. Equipment shall accept, at a minimum, 15 characters in specimen identifier that is alpha and/or numeric.

2.3.9.8. Minimal daily, monthly, and periodic maintenance.

2.3.9.9. Ability to print, store, and retransmit records (24 hours of maximal instrument throughput- the analyzer can store up to 999 patient test results, hours of storage depend on test volume) in case of interface outage.

2.3.9.10. Capability to detect out of range quality control.

2.3.9.11. Ability to manually program the performance of QC testing.

2.3.9.12. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 10 to 30°C (50°F and 90°F).

2.3.9.13. Built-in quality control program to regularly monitor system performance.

2.3.9.14. Ability to monitor instrument performance.

2.3.10. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

2.3.10.1. The capability of accurately and reliably identifying organisms directly from specimens including positive blood cultures, spinal fluid, synovial fluid, stool, upper and lower respiratory tract.

2.3.10.2. Positive blood cultures target organisms and antibiotic resistance genotypes should minimally include:

2.3.10.2.1. Acinetobacter calcoaceticus-baumanii complex, B. fragilis, Enterococcus, Listeria monocytogenes,S. aureus, S. agalactiae, S.

pyogenes, S. pneumoniae, Staphylococcus spp., S. epidermidis, S.

lugdunensis, H. influenzae, N. meningitidis, P. aeruginosa, E. cloacae complex, E. coli, K. oxytoca, K. pneumoniae, Proteus, S. marcescens, Salmonella spp., S. maltophilia, C. albicans, C. auris, C. glabrata, C.

krusei, C. parapsilosis, C. tropicalis, Cryptococcus, mecA/C, MERJ, vanA/B, IMP, KPC, OXA-48-like, NDM, mcr-1, and CTX-M.

2.3.10.3. Upper Respiratory specimen target organisms should minimally include:

2.3.10.3.1. Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human metapneumovirus, Influenza A virus, Influenza B virus, Parainfluenzae virus, RSV, Rhinovirus/Enterovirus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumonia, and Mycoplama pneumonia.

2.3.10.4. Lower Respiratory specimen target organisms should minimally include:

2.3.10.4.1. Acinetobacter calcoaceticus-baumannii complex, E. cloacae complex, E.

coli, H. influenzae, K aerogenes, K. oxytoca, K. pneumoniae, M.

catarrhalis, Proteus spp., P. aeruginosa, S. marcescens, S. aureus, S.

agalactiae, S. pneumoniae, S. pyogenes, C. pneumoniae, L.

pneumophila, M. pneumoniae, Adenovirus, Coronavirus, Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A virus, Influenza B virus, RSV, IMP, KPC, NDM, OXA-48-like, VIM, CTX-M, mecA/C, and MERJ

2.3.10.5. Spinal fluid specimen target organisms should minimally include:

2.3.10.5.1. E. coli K1, H. influenzae, L. monocytogenes, N. meningitidis, S.

agalactiae, S. pneumoniae, CMV, EV, HSV-1, HSV-2, HHV-6, HPeV, VZV, and Cryptococcus

2.3.10.6. Synovial fluid specimen targe organisms should minimally include:

2.3.10.6.1. Anaerococcus prevotii/vaginalis, C. perfringens, C. avidum/granulosum, E. faecalis, E. faecium, F. magna, P. micra, Peptoniphilus, P.

anaerobius, S. aureus, S. lugdunensis, Streptococcus spp., S.

agalactiae, S. pneumoniae, S. pyogenes, Candida spp, C. albicans, IMP, KPC, NDM, OXA-48-like, VIM, CTX-M, mecA/C, MERJ, and vanA/B

2.3.10.7. Stool specimen target organisms should minimally include:

2.3.10.7.1. Aeromonas, Campylobacter, C. difficile (ToxA/B), P. shigelloides, Salmonella, Vibrio, V. cholera, Y. enterocolitica, E. coli 0157, EAEC, EPEC, ETEC, STEC, EIEC, Adenovirus, Astrovirus, Norovirus, Rotavirus, Sapovirus, Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, and Giardia lamblia.

2.3.11. Data Management- The System shall have the following:

2.3.11.1. Capability to record, store and print the following information:

2.3.11.1.1. Required quality control and instrument maintenance information.

2.3.11.1.2. Patient demographic information and specimen results.

2.3.11.1.3. Sufficient memory to store patient information and test results with downloading capability to an external medium for long term storage of patient records and other information.

2.3.12. Hardware Features- The instrumentation shall have the following:

2.3.12.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

2.3.12.2. An on-board monitor/screen that is easily readable.

2.3.12.3. Printers that have the capability of printing a patient report with patient demographic information that includes the patient’s name, medical record number (SSN) and accession or unique identifier number (UID).

2.3.12.4. An uninterruptible power supply with line conditioner for each instrument provided.

2.3.13. Support Features-

2.3.13.1. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer 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.

2.3.13.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

2.3.14. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two (2) operators per facility per year at the discretion of the VA for each model of instrumentation placed.

Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant. Contractor may offer two

(2) classroom training slots for each participating VA location (base year only) in lieu of in-depth on-site or virtual training, for which the Contractor shall cover the cost of airfare, room and board for each participant traveling off-site. Follow up to classroom training in the base year and any subsequent option years (if requested) will occur on-site with a Field Application Specialist (FAS) in a train-the-trainer model (minimum 2 operators per facility) or virtual training. Training paths may be unique to each VA location.

2.3.15. Service Requirements - Equipment Preventative Maintenance/Repair Service – The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, offered according to the following terms:

2.3.15.1. Vendor shall provide at a minimum, standard one-year warranty from date of shipment.

2.3.15.2. A 2-year service agreement after 1st year of warranty coverage.

2.3.15.3. A technical assistance center shall be available by telephone twenty-four

(24) hour per day, seven (7) days per week (24/7) with a maximum call back response of two (2) hours after vendor notification.

2.3.15.4. Equipment repair service shall be provided on site during core business hours within twenty-four (24) hours. If equipment malfunction is deemed to jeopardize the need for continuation of patient care, then the vendor will provide an emergent on-site repair service to be conducted outside routine business hours within twenty-four (24) hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

2.3.15.5. Equipment repair response time shall be no more than two (2) hours after vendor notification.

2.3.15.6. Preventative maintenance will be performed on all primary and back-up instrumentation and any incremental support equipment as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2.3.15.7. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

2.3.15.7.1. date and time notified

2.3.15.7.2. date and time of arrival

2.3.15.7.3. serial number, type and model number of equipment

2.3.15.7.4. time spent for repair, and

2.3.15.7.5. proof of repair that includes documentation of sample run of quality control verifying acceptable performance

2.3.15.7.6. Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.3.16. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order 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, expanded database, 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 if the new equipment is deemed superior by the receiving facility and results in significant changes in the hardware operational capability.

2.3.17. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

2.3.18. Software, Connectivity and Conformance Standards – The instrument software shall have capability to connect to other equipment and software systems that meet the following requirements:

2.3.18.1. Instrument Software – Internal testing instrumentation software that provides/maintains the following:

2.3.18.1.1. Ability to monitor instrument performance.

2.3.18.1.2. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

2.3.18.1.3. Capability to detect and alert operator of out-of-range quality control results via flagged results on QC printout and visual alerts on display monitor.

2.3.18.1.4. Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 72 hours in case of interface outage.

2.3.18.1.5. Capability to record, store and print the following information:

2.3.18.1.5.1. Quality control, calibration, and instrument maintenance information.

2.3.18.1.5.2. Patient demographic information and specimen results.

2.3.18.1.6. The capability to program a test as a repeat with interfacing of results to overlay initial result.

2.3.18.1.7. Ability to retransmit patient records to the Laboratory Information System (including contractor provided middleware) in case of interface outage.

2.3.18.2. Interface –

2.3.18.2.1. Contractor shall provide a bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software as needed) shall be immediately available for implementation to the VA computerized hospital information system or General Interface Manager (Middleware)

2.3.18.2.2. The Contractor shall provide all system configuration options and diagrams for any hardware and/or software, with annotation of whether contractor provided, or VA provided, required for the connection, implementation, and operation of the interface to the VA licensed Middleware.

2.3.18.2.3. The Contractor shall provide all necessary software support for ensuring successful interfacing with the middleware, remote connections and LIS system has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

2.3.18.2.4. The contractor provided hardware and software solution shall meet all VA Information Security, Hardware, Software and Network requirements in accordance with (IAW) VA Directive 6500. Any wireless equipment must be FIPS 140-2 compliant as well, and contractor must provide the FIPS 140-2 certification for any wireless equipment upon request.

2.3.18.2.5. All technology Contractor provides shall interface to VA licensed middleware sending all appropriate information to complete auto verification rules processing within the VA licensed middleware.

2.3.18.2.6. The contractor shall provide at no additional cost, software upgrades required to meet system operations, interfaces and security compliance.

All upgrades shall occur with coordination and agreement of the VA sites.

2.3.18.3. Connectivity and Conformance –

2.3.18.3.1. Contractor must have a Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA in sufficient time to meet the installation timeframes.

https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CRISPR em ediationContract/WorkSite/SitePages/MOU-ISA_Version2.aspx

2.3.18.3.2. Contractor shall meet VA OI&T information security requirements IAW VA Directive 6500.

2.3.18.3.3. The system’s operating software version must be approved for use on the VA network (Windows 10 and Server 2019).

2.3.18.3.4. The system must be capable of connecting to an HL7 interface and must comply with the VHA Lab HL7 Interface Specifications Document.

2.3.18.3.5. The vendor must supply the cables and adapters necessary to establish interface connectivity (May include RS232 to network adaptor, Network card, cat 6 cables, etc.) https://www.va.gov/vdl/application.asp?appid=71 https://www.va.gov/vdl/application.asp?appid=75

2.3.18.3.6. Any software and hardware solutions supplied and installed on VA workstations by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must appear on a TRM that is within 2 lifecycles of the most recent TRM approved version. For software or hardware solutions that do not meet these requirements at the time of contract award, Contractor shall obtain the required TRM approval without impacting installation timeframes https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx.

2.3.19. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software.

2.3.20. 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 make a determination if the waste is a hazardous waste or otherwise regulated.

2.3.20.1. The determination and description shall address the following:

2.3.20.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2.3.20.1.2. Waste ignitability (Reference 40 CFR §261.21)

2.3.20.1.3. Waste corrosivity (Reference 40 CFR §261.22)

2.3.20.1.4. Waste reactivity (Reference 40 CFR §261.23)

2.3.20.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40

CFR §261.31)

2.3.20.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

2.3.20.1.7. Solid Waste (Reference 40 CFR §261.2)

2.3.20.1.8. Exclusions (Reference 40 CFR §261.4)

2.3.20.2. The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.3.20.3. Contractor shall provide a description of all wastes the process or equipment may discharge so that the…