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

36C26223Q1359

Carlos Magana (951) 601-4544

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

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) ... 34

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

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 34

C.6 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

C.10 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 Immunohistochemical (IHC) and In-situ hybridization (ISH) Equipment Capital Purchase and CPT Solution 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 four (4) 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 four 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 09-15-2023 – 08-14-2024 OBLIGATION NUMBER: TBD

OPTION PERIOD 1 09-15-2024 – 08-14-2025 OBLIGATION NUMBER: TBD

OPTION PERIOD 2 09-15-2025 – 08-14-2026 OBLIGATION NUMBER: TBD

OPTION PERIOD 3 09-15-2026 – 08-14-2027 OBLIGATION NUMBER: TBD

OPTION PERIOD 4 09-15-2027 – 08-14-2028 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:

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

Alt. Phone No:

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: 36C26218A0032

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 08/14/2028or 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. DESCRIPTION AND REQUIREMENTS OF THE CONTRACT

1.1 This is a Blanket Purchase Agreement Contract (BPA) pursuant to Federal Acquisition Regulation (FAR) Part 12 and FAR Part 13.303 for the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22. This BPA is for a Cost Per Test (CPT) system that shall provide all Immunohistochemical (IHC) and In-situ hybridization (ISH) related testing within VISN 22. This BPA requires that the contractor shall provide a system that can conduct all testing as outlined in Attachment A tabs 1 and 2. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed in 1.6. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement between the Government and the Contractor.

1.2 This BPA does not obligate any funds. The Government is obligated only to the extent of authorized delivery/task orders (DO/TO) issued under the BPA by contracting officers (CO) for VISN 22 and the minimums established under section 1.3 which will be obligated via authorized DO/TO’s. All products ordered under DO/TO’s shall be subject to the terms and conditions of this BPA.

1.3 VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this BPA that are related to the use of IHC/ ISH requirements. All attachments identified in section D 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 in Section D attachments that may arise.

1.4 The BPA base period shall be for a period of one (1) year with four (4) one-year (1) options.

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: (TBD upon award, target date of 09-15-2023

1.4.2 Overall with Options: (TBD upon award, target date of 09-15-2023 08-14-2028)

1.5 Delivery Orders issued shall be identified by BPA Number ________ (To Be Determined upon award).

1.6 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.

1.6.1 VA Greater Los Angeles Healthcare System | 11301 Wilshire Blvd, Los Angeles, CA

90073

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

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

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

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

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

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

1.7 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.

1.7.1 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 as defined throughout section 1.7.

1.7.2 Attachment A, Tab 1, “VISN CPT” shall provide CPT pricing based upon other tabs in the Schedule which are also reflected in Column C. Column E provides the Total CPT for every test for years one (1) through five (5) of the BPA. The cost of instrumentation, software (not including annual licenses), other equipment and installation shall only apply to years one (1) – five (5) of the CPT or when the initial five (5) year volume is reached.

1.7.3 Attachment A, Tab 2, “EST ANNUAL SITE VOL” provides estimated test volumes for all minimally required tests under this BPA. These volumes are based upon current usage and utilize a 5% repeat rate and a 3% increase in volume as reflected in Tab 1.

1.7.4 Attachment A, Tab 3, “REAGENTS CPT” provides a component of the total Cost Per Test under column B for each required test. The amounts listed in column B only refer to the cost of reagents and consumables required to run a test and is reflected in Tab 1. Column D clearly identifies that exact quantities of reagents and consumables needed to a run a single test.

1.7.5 Attachment A, Tab 4, “INSTRUMENTS” provides what instrumentation and related equipment the contractor shall provide and their individual associated costs. Column L shall provide total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.7.6 Attachment A, Tab 5, “OTHER” provides what ancillary items and other items the Contractor shall provide as a part of the CPT. Also include training slot costs and other related services. Column L shall provide total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.7.7 Attachment A, Tab 6, “SERVICE” provides the CPT cost of service/maintenance and software licenses for duration of the BPA under column M.

1.7.8 Attachment A, Tab 7, “INSTALL” provides the cost of initial installation and a clear description of all installation activities. Column C provides total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.7.9 Attachment A, Tab 8, “IND ITEM COST” provides the individual cost of all items within the CPT and items available to optionally purchase individual separate from the CPT.

1.7.9.1 Also includes the cost expedited shipping as individual line items by facility.

1.7.9.2 Includes the cost of additional training slots beyond the initial amount offered under the CPT.

1.8 Introduction and Scope of Required Specifications

1.8.1 The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work for all IHC and ISH. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting 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).

1.8.2 Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory as defined by volumes in Attachment A Tab 2.

1.8.3 The Contractor is required to provide a continuously stocked inventory of reagents, standards, antibodies, secondary stains, consumable 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.

1.8.4 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 1.6 and Attachment A.

1.8.5 Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for IHC/ISH equipment, supplies and related services.

1.9 Definitions

1.9.1 Cost per Test (CPT) – Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services and installation as defined throughout section 1.7. CPT pricing is billed per test as per Attachment A and Section 1.7.

1.9.2 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.

1.9.3 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).

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

1.9.5 TEST MENU: Refer to Attachment A Tab 1 and 2 for test menu and estimated annual volumes by laboratory.

1.10 Instrumentation Requirements

1.10.1 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 technical specifications of this contract.

1.10.2 Contractor shall provide an Integrated Clinical Laboratory IHC and ISH Instrumentation in accordance with the Attachment A.

1.10.3 Fully automated instrument with the defined capabilities:

1.10.3.1 Baking

1.10.3.2 Deparaffinization

1.10.3.3 Cell Conditioning

1.10.3.4 Staining

1.10.3.5 IHC

1.10.3.6 ISH

1.10.3.7 SISH

1.10.3.8 Immunofluorescence

1.10.3.9 Multi-parameter IHC (double, triple)

1.10.3.10 Counter Statin

1.10.3.11 Titration

1.10.4 Equipment shall have sufficient capacity and throughput to meet the volume and service demands as defined in Attachments A Tab 2 during peak workload analysis. The solution should allow for 3% growth in volume per year for the term of the contract with options.

1.10.5 The capability of performing analysis on 100% of the required tests listed in section Attachment A Tab 1/2.

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

1.10.7 System shall include a stain status display for staff review and workflow management for all integrated (linked) testing instrumentation. All monitors/screens will clearly display information in all light conditions.

1.10.8 Preference will be given to vendors that offer barcode interface programming capability with the Laboratory Information System.

1.10.9 Random access capability.

1.10.10 The ability to continuously load patient slides for staining.

1.10.11 Ability to add/remove reagents without interrupting cases in process.

1.10.12 Flexibility to add/remove slides without impacting workflow.

1.10.13 The capability of incorporating third party stains on the instrument.

1.10.14 Instruments must offer easy to read, printable staining reports.

1.10.15 Instruments must have barcoded reagents. Instruments must have capability to ensure that one can’t use reagents if they are expired or if the volume of the reagents is insufficient to complete the run.

1.10.16 Instruments must have easy slide insertion- with no extra pieces to position.

1.10.17 Instruments must automatically track insufficient reagent quantity and alert for tests remaining.

1.10.18 Button and barcodes automatically register and locate staining kits and slides.

1.10.19 Instrument must have independently functioning slide staining chambers to preserve sample integrity and eliminate the need for batch runs.

1.10.20 Minimum of 35 reagent positions.

1.10.21 Individually temperature-controlled slide drawers with continuous access to slides improves throughput.

1.10.22 Process up to 90 slides in 8 hours, or 120 slides with an overnight run.

1.10.23 Ability to add “STAT” requests with no interruption to routine runs.

1.10.24 The IHC platform must be capable of completing multiple runs during an 8 hour day.

1.10.25 Simultaneous IHC, ISH, SISH, Dual Stain, and FITC slide processing and titration.

1.10.26 Ultimate Reagent Access (URA) provides frequent access to reagent.

1.10.27 Optimized protocols with flexible options including variable incubation times and temperatures.

1.10.28 Vendor must offer prepackage bulk solution reagent kits with no mixing

1.10.29 Continuous access to bulks and waste for improved workflow.

1.10.30 The IHC platform require provisions to reduce exposure to harmful chemicals to staff.

1.10.31 Remote support for trouble shooting and training.

1.10.32 On-site training provided for each user.

1.10.33 Cost of service to be included in pricing (1st year instrument is under warranty and service is included in remaining 4 years). Vendor must include preventive maintenance visits, decontamination visits to site to repair instrument when down, and technical support call line as part of the contract.

1.10.34 Printers and Other Support Items (Support Items)

1.10.34.1 A printer(s) that has 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). The contractor must repair or replace the printer if malfunctioning within 24 hours for the duration of the contract.

1.10.34.2 An uninterruptible power supply (UPS) with line conditioner for each instrument provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

1.11 Software, Connectivity and Conformance Standards

1.11.1 Instrument Software – Internal to testing instrumentation that provides/maintains the following:

1.11.1.1 Ability to monitor instrument performance.

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

1.11.2 Interface

1.11.2.1 The contractor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (See attachment ___ VA 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.

1.11.2.2 Must be compatible with specimen tracking systems, universal interface.

1.11.2.3 Upon request, the Contractor shall provide support for connecting to a specimen tracking system, including, but not limited to data lines, adapters, and licenses.

1.11.3 Connectivity and Conformance

1.11.3.1 The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Risk Analysis Tool.

1.11.3.2 The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 and Server 2012/2016).

1.11.3.3 Any software 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 be within 2 lifecycles of the most recent TRM approved version. Or the contractor must have the capability obtain a TRM approval without impacting installation timeframes in section 4.

https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx.

1.11.3.4 If providing remote support, the Contractor must have a Memorandum of Understand/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without impacting installation timeframes in section 4.

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

1.11.4 Value Add – Specimen Tracking System

1.12 Support Features

1.12.1 Service Maintenance / Warranty

1.12.1.1 The Contractor shall be able to provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system.

1.12.1.2 The contractor provides a technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour

1.12.1.3 All equipment, including ancillary equipment, repair service shall be provided Monday through Friday from 8:00a.m. to 4:00p.m local time. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. If one analyzer is down service converts to 24/7 to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 4 hours. Delivery of parts and equipment to fix instrumentation must be within 24 hours to prevent excessive downtime at the cost of the contractor.

1.12.1.4 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date or more frequently based on instruments’ performance.

1.12.1.5 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:

date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

Cause (i.e. user error, part failure, etc…) Each notification for an emergency repair service call shall be treated as a separate and new service call.

1.12.1.6 The Contractor shall provide, install, maintain, and repair 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. UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, deionizers, filters, preventative maintenance and repair, 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.

1.12.1.7 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 CLSI format or an on-line procedure manual in the instrument software.

1.12.1.8 Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

1.12.2 This section establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the go live date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in the BPA at an effectiveness level of 90% or more.

1.12.2.1 In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

1.12.2.2 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement at no charge or terminate the order in accordance with the provisions of FAR 52.212- 4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

1.12.2.3 Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

1.12.2.4 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

1.12.2.5 The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

1.12.2.6 During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination may be made by the COR and contracting officer to replace the malfunctioning equipment with new equipment at no additional charge. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the contract. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system, printers, UPS, etc.

1.12.2.7 The Contractor shall provide a warranty for all items and services provided under the BPA for the duration of the BPA and all associated delivery orders

1.12.3 Reports

1.12.3.1 All reports must be approved by the medical director. Additional studies will be at the expense of the contractor until results meet the criteria defined by the medical director.

1.12.4 Training

1.12.4.1 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. The CPT shall include key operator training for minimally 2 operators per each instrument installed. Training shall be provided on the operation of the system, data manipulation, and basic trouble shooting and repair.

Thereafter, the Contractor shall provide training for minimally two operators per facility per year at the discretion of the Government 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.

1.12.4.2 In addition, operator training shall be provided by Contractor on-site for all operators on all shifts (day shift: 0700 – 1530, evening shift: 1500 – 2330 and midnight: 2300 – 0730), as applicable.

1.12.4.3 Additional onsite training will be provided 60-90 days after instrumentation’s go live date.

1.12.4.4 Contractor shall at minimum provide on-site training for up to 8 hours per site as requested by the facility.

1.12.4.5 Contractor will provide example policies and procedures such as standard operating procedure templates.

1.12.5 Waste

1.12.5.1 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. The determination and description shall address the following:

Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR

§261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4)

1.12.5.2 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.

1.12.5.3 Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review.

1.12.5.4 The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system

1.12.6 Upgrade/Updates: The Contractor shall provide updates 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 updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update 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. Should the VISN decide to upgrade their current equipment ie. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

2. PACKAGING & MARKING

2.1 Packaging

2.1.1 All equipment and 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.

2.2 Marking

2.2.1 All items shall be marked clearly with the BPA Number, Delivery Order Number, Obligation number and delivery location within the hospital ie. Emergency Room. For major Equipment, the Obligation number shall begin with an A after the station number ie.

600A20000. All other service items shall be marked with a C number ie. 600C20001. The Delivery Order number shall have a format similar to this example: 36C26223N1234.

3. DELIVERIES & PERFORMANCE

3.1 Installation/Implementation

3.1.1 Implementation/transition timeframe: All sites shall have complete installation and go live of their system within one year of award of this BPA.

3.1.2 Contractor shall execute an implementation plan which includes:

3.1.2.1 Installation - Contractor shall make every effort to conduct a concurrent implementation at all sites with weekly collaborative meeting. Contractor shall provide a dedicated project manager throughout the entire implementation.

Installation shall also include conversion of all current data minimally including operator profiles.

3.1.2.2 Testing- Shall include at minimum a test of all analytes in addition through all testing phases (pre- analytical, analytical, and post-analytical). In addition, training must be provided to all sites.

3.1.2.3 Acceptance-Must meet the approval requirements of accrediting agencies and laboratory medical director approval at each facility to meet accreditation standards.

3.1.2.4 Go-Live- Dedicated project management and technical support must be available above the requirements the day of go-live at each site for 3 days.

3.1.2.5 Post Go-Live Follow Up- Check-in should include at least a two week and 30 day after go-live date.

3.1.2.6 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. This applies to equipment as well as additional or replacement equipment placed under the terms and conditions of this BPA. The Contractor shall perform/, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all statistical analysis as stated in the Method Performance/Validation section below and provide a hard copy of data in an organized, clearly comprehensible format.

3.1.2.7 Onsite Go live Instrument Support Requirements shall consist of 2 days of continuous support. Daily onsite support for a total of five business days for each phase of implementation.

3.1.3 Must support successful implementation and a non-manual method of uploading historical data, i.e. operators and meters/analyzers in the transition from different system.

3.1.4 Method Performance / Validation

3.1.4.1 The Contractor will assist (if needed) each VA Histology laboratory optimize each non-predictive factor assay. Note: Contractor will not help with laboratory-developed predictive marker assays.

3.1.4.2 Method performance/comparison shall be at the expense of the Contractor, shall include all reagents, and consumables to meet the validation standards defined by CLIA. standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include histology, cytology, and bone marrow specimens (decalcified tissue). as applicable and must be approved by the medical director.

3.1.4.3 For initial analytic validation of non-predictive factor assays, each VA Histology laboratory should test a minimum of 10 positive and 10 negative cases.