S02 - RFQ 36C26224Q1272.docx

36C26224Q1272

‘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

36C26224Q1272

Marcos Diaz

(762) 566-2333

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

VISN 22

See Section B-Paragraph B.2.6

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

Financial Services Center

See CONTINUATION Page

Blood bank Automation CPT Solution

See CONTINUATION Page

Table of Contents

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:

1. CONTRACTOR:

a. GOVERNMENT:

Contracting Officer (CO): Ceponis, Kevin Department of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600 Long Beach CA 90815 Kevin.Ceponis@va.gov

Contracting Officer (CO): Diaz, Marcos Department of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600 Long Beach CA 90815 Marcos.Diaz@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:

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 15, 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 Blood Bank Automation, 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:

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.

1. TERM OF AGREEMENT:

This BPA shall be one (1) 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.

1. BPA LIMITS:

The estimated BPA time is approximate One (1) Base year and four (4) 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. Estimated Period of Performance follows.

1. 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.

1. 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.

1. 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.

VA New Mexico Healthcare System (NMVAHS) Laboratory & Pathology Department 1501 San Pedro SE Albuquerque, NM 87108 VA Phoenix Healthcare System (PVAHS) Laboratory & Pathology Department 650 E. Indian School Road Phoenix, AZ 85012

VA Southern Arizona Healthcare System (SAVAHS) Laboratory & Pathology Department 3601 S 6th Ave Tucson, AZ 85723 VA Northern Arizona Healthcare System (VAPHS) Laboratory & Pathology Department 500 Hwy 89N Prescott, AZ 86313

VA Loma Linda Healthcare System (VALLHS) Laboratory & Pathology Department 11201 Benton Street Loma Linda, CA 92357 VA San Diego Healthcare System (VASDHS) Laboratory & Pathology Department 3350 La Jolla Village Dr.

San Diego, CA 92161

VA Long Beach Healthcare System (VALBHS) Laboratory & Pathology Department 5901 E. 7th Street Long Beach, CA 90822 VA Greater Los Angeles Healthcare System West LA Campus (VAGLAHS) Laboratory & Pathology Department 11301 Wilshire Blvd Los Angeles, CA 90073

1. BPA PROGRAM MANAGER:

The Contractor shall provide in the spaces below 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 Line 1

Line 2

Line 3

Direct Phone No

Alt. Phone No

Fax No

Email

1. 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.

Contact Name

Contact Title

Address Line 1

Line 2

Line 3

Direct Phone No

Alt. Phone No

Fax No

Email

Contact Name

Contact Title

Address Line 1

Line 2

Line 3

Direct Phone No

Alt. Phone No

Fax No

Email

1. 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 4:30p.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.

1. 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.

1. 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).

0. Facility name and address where service was provided.

0. BPA Number: Example: 36C26224A0001

0. Purchase Order Number: Example: 36C26224N0002

0. Obligation Number: Example: 600-C80001

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

0. In invoice, include the period of time that is being invoiced for.

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

0. 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 an as needed 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 09/30/2029 or such 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): Ceponis, Kevin Department of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600 Long Beach CA 90815 Kevin.Ceponis@va.gov

Contracting Officer (CO): Diaz, Marcos Department of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive, Suite 600 Long Beach CA 90815 Marcos.Diaz@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.

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. Introduction and Scope of Requirements:

The contractor shall provide Blood Bank Automation equipment that meets all the following requirements:

1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined herein for all Blood Bank Automation equipment related testing. The instrument shall be capable of reflex testing from macroscopic to microscopic evaluations. The instrument shall be capable 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). The contractor shall identify if their test and specimen types are Food and Drug Administration (FDA) approved.

1.2. Equipment: All equipment delivered to the participating medical center shall be new, state of the art, and not recertified nor refurbished.

1.3. Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment is present in the current marketplace for Clinical Blood Bank Automation equipment, supplies and related services.

1.4. Contractor must follow all applicable state, federal and local laws, and regulations related to laboratory testing.

2. General Requirements:

2.1. Automated Blood Bank Analyzer – Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human immunohematology test results. The analyzer offered by the contractor shall fully support the estimated annual site volume listed on the schedule.

2.2. Consumables and Reagents Definition: Contractor shall provide all supplies, reagents, consumables required for the installation/validation of the analyzer system free of charge as a component of this contract. This requirement includes all reagents, calibrators, controls for the analyzer(s). This requirement includes consumable hardware such as needles, probes, syringe tips, automated pipette tips and supplies. This requirement includes printer ribbons for specialty printers, buffers, diluents, and cleaners. This requirement includes supplies for ancillary equipment such as water system filters, membranes and polishers, air filters, light bulbs, specialty barcode labels.

2.3. ABO/Rh: Red cell antigen testing to confirm presence or absence of ABO and Rh antigens.

2.4. Antibody Screen: Serologic testing to confirm presence of unexpected antibodies to human blood group systems as needed: 2-cell Ab screen and/or 3 cell Ab screen based on facility process as requested in test volumes

2.5. Antibody Identification: Serologic testing through a multicell panel with built in auto control to identify patterns of antibody presence.

2.8. Crossmatch: Compatibility testing between patient and donor unit(s).

2.9. ABO and Rh Confirmation: ABO and Rh testing, as required, FOR BOTH patients and donors. Confirmation is FOR BOTH patients and donors. Forward and reverse for patients. Forward only for units.

2.10. Eluate Panel (not required, value added): Antibody identification utilizing eluted antibodies from a patient sample through use of a multicell panel.

3. Instrumentation Requirements:

3.1. Analyzer(s) – Contractor shall provide automated blood bank analyzers that meet the following requirements:

3.2. Other Primary Hardware Features: Contractor shall provide automated blood bank equipment that meets the following requirements:

3.2.5.1. Value added option: System is capable of auto reflexing testing as defined by operator without additional manipulation. (See line 4.2.2 for further explanation)

up to 48”L X 36”D x 37”H with cart, no weight restrictions

3.3. Barcoding – Contractor shall provide barcoding stations located at user monitoring stations along the line or track system and must have the following capabilities:

4. Software, Connectivity and Conformance Standards:

The instrument software shall have capability to connect to other equipment and software systems that meet the following requirements:

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

- Quality control, calibration, and instrument maintenance information.

- Patient demographic information and specimen results.

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

4.2. Customization

4.3. Interface

4.3.1. Interface Requirements

4.4. Connectivity and Conformance

https://www.va.gov/vdl/application.asp?appid=71 https://www.va.gov/vdl/application.asp?appid=75

4.4.6. 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.

4.4.7. Offeror must have an approved existing VBECS VistA Blood Establishment Computer Software (VBECS) interface supported by the VA VBECS team. VBECS is a computer software application that manages transfusion service activities. The purpose of VBECS is to automate the documentation and record keeping of selected daily activities of the transfusion service.

5. Packaging & Marking:

5.1. Packaging

5.1.1. All equipment 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.

5.2. Marking

5.2.1. All items shall be marked clearly with the Contract Number, Obligation number, and delivery location within the facility, i.e., Pathology & Laboratory Services.

6. Installation/Implementation:

6.2. Contractor shall execute an implementation plan which includes:

7. Method Performance / Validation:

7.1. Method performance/comparison shall be at the expense and responsibility of the Contractor for all tests performed on analyzer(s). This shall include linearity material and reagents as required or recommended based on manufacturer’s specifications, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. The Method Validation will include the following:

7.2. Analytical Measurement Range (AMR) validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. This linearity analysis shall be performed for each measured test parameter provided.

7.3. Sensitivity may be validated concurrently with the linearity verifications.

7.4. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

7.5. A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects with medical director approval. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

7.6. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

7.7. If a laboratory is currently using the proposed instrument/reagent system, the “in use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

8. Delivery and Hours of Operation:

The Contractor shall deliver all Automated Blood Bank equipment to appropriate VA medical facilities listed below.

8.3. Delivery hours - normal tour-of-duty hours are 8:00am to 4:30pm, Monday through Friday, excluding Federal holidays in accordance with 5 U.S. Code § 6103. Furthermore, when a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

8.4. Delivery Locations Within VISN 22:

VA New Mexico Healthcare System (NMVAHS) Laboratory & Pathology Department 1501 San Pedro SE Albuquerque, NM 87108

VA Long Beach Healthcare System (VALBHS) Laboratory & Pathology Department 5901 E. 7th Street Long Beach, CA 90822

VA Loma Linda Healthcare System (VALLHS) Laboratory & Pathology Department 11201 Benton Street Loma Linda, CA 92357

VA Phoenix Healthcare System (PVAHS) Laboratory & Pathology Department 650 E. Indian School Road Phoenix, AZ 85012

VA San Diego Healthcare System (VASDHS) Laboratory & Pathology Department 3350 La Jolla Village Dr.

San Diego, CA 92161

VA Southern Arizona Healthcare System (SAVAHS) Laboratory & Pathology Department 3601 S 6th Ave Tucson, AZ 85723

VA Northern Arizona Healthcare System (VAPHS) Laboratory & Pathology Department 500 Hwy 89N Prescott, AZ 86313

VA Greater Los Angeles Healthcare System West LA Campus (VAGLAHS) Laboratory & Pathology Department 11301 Wilshire Blvd Los Angeles, CA 90073

9. Support Features:

9.1. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this contract, “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.

9.2. 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), 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 the statistical analysis as stated in the Method Performance/Validation section 7 above and report data in an organized, clearly comprehensible format.

9.3. Training.

9.3.3. Follow up to classroom training in base year and any subsequent option year (if requested) should occur on-site with a Field Application Specialist (FAS) in a train-the-trainer model (up to two (2) operators per facility) or virtual training. Training paths can be unique to each VA location.

10. Equipment Preventative Maintenance/Repair Service:

10.1. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, offered according to the following terms:

10.2. 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, 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 contract; however, it does refer to significant changes in the hardware operational capability.

10.3. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract, 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, UPS units 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.

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

10.5. Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is a hazardous waste or otherwise regulated.

10.6. 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.