36C25518Q9713-001.docx

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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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25518Q9713 09-05-2018 Kittling, Yvonne yvonne.kittling@va.gov 913-946-1981 09-24-2018

1000 AM CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 x 532490 $32.5 Million N/A X Department of Veterans Affairs St Louis and Kansas City VAMCs

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page This solicitation is to establish a Requirements Contract for immunochemical stainer instrumentation and associated reagents.

Facilities:

VA Medical Center, 4801 Linwood Blvd, Kansas City, MO 64128 VA Medical Center, 915 N Grand Blvd, St. Louis, MO 63106 Submit questions no later than 9/17/2018. All questions will be consolidated and one amendment with answers will be posted on www.fbo.gov no later than 9/20/2018.

See CONTINUATION Page X X Yvonne Kittling Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(Continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: NAME: ___________________________________

DUNS #: __________________________________

b. GOVERNMENT: CONTRACTING OFFICER 36C255

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE (NCO) 15

3450 S 4th STREET

LEAVENWORTH, KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted:

[X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp

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

Page 1 of Page 1 of

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION – Please complete Attachment A with list of items

AMOUNT

PERIOD OF PERFORMANCE 11/1/2018 – 10/31/2019

PERIOD OF PERFORMANCE 11/1/2019 - 10/31/2020

PERIOD OF PERFORMANCE 11/1/2020 - 10/31/2021

PERIOD OF PERFORMANCE 11/1/2021 - 10/31/2022

PERIOD OF PERFORMANCE 11/1/2022 - 10/31/2023

B.3 DELIVERY SCHEDULE

Department of Veterans Affairs Kansas City VA Medical Center 4801 Linwood Blvd Kansas City, MO 64128-2226

Department of Veterans Affairs St. Louis VA Health Care System John Cochran Division 915 N Grand Blvd, BLDG 1 Saint Louis, MO 63106-1621

No Later Than (NLT) 11/1/2018 – 10/31/2023

B.4 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1.1. INTENT: it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish a REQUIREMENTS CONTRACT for immunochemical stainer instrumentation and associated reagents. The REQUIREMENTS CONTRACT shall be a single vendor award for Cost Per Test placement of instrumentation and a reagent purchase agreement for the associated reagents. The contractor agrees to the following terms of the REQUIREMENTS CONTRACT exclusively with the VISN facilities listed in Attachment A and awarded in the final REQUIREMENTS CONTRACT. Additional instrumentation and reagents may be added to the REQUIREMENTS CONTRACT as new technology becomes available on the market.

1.2. ORDERS: The Government is obligated only to the extent of authorized orders actually issued under the REQUIREMENTS CONTRACT by authorized individuals.

1.3. PRICES AND TERMS: VISN 15 will provide an estimated volume by reagent/supplies as reflected in Attachment A for each individual medical center. The Government estimates the volumes per facility as listed in Attachment A, but does not guarantee volumes as listed; they are estimates ONLY.

1.4. TERM OF AGREEMENT: This will be a single contractor award, firm-fixed price REQUIREMENTS CONTRACT with one base plus four one-year options. VISN 15 intends to establish the base year of the agreement for the period of 11/1/2018 through 10/31/2023.

1.5. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable Purchase Order Number.

1.6. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

1.7. DELIVERY TICKET: Unless otherwise agreed, all deliveries under the REQUIREMENTS CONTRACT must be accompanied by delivery tickets or sales slips that must contain the following information as a minimum:

1.7.1. Name of Contractor

1.7.2. Contract number

1.7.3. REQUIREMENTS CONTRACT number

1.7.4. Model number or National Stock Number (NSN)

1.7.5. Purchase order number

1.7.6. Date of purchase

1.7.7. Quantity, unit price, and extension of each item (unit prices and extensions need not be shown when incompatible with the use of automated systems; provided that the invoice is itemized to show the information)

1.7.8. Date of shipment

1.8. DELIVERY TERMS: The delivery terms for all items ordered under the REQUIREMENTS CONTRACT will be FOB Destination. Contractor will make shipping arrangements and prepay all shipping and handling costs. Contractor will promptly replace all Products lost or damaged in shipment. Contractor will be responsible for all disputes with the shipper and all insurance claims related to the shipment.

1.9. RETURNS: Contractor will accept return of erroneously shipped Products, in accordance with the following: Contractor will credit Customer 100% of the Purchase Price for Products returned due to shipping errors, provided that Customer requests a Return Material Authorization (RMA) number from the Contractor in its notice to Contractor of a shipping error, and that Customer returns the Products within (30) days after its receipt of a RMA number. Returns will have RMA number written clearly on the outside of the shipping container. Contractor will not accept returns of Products ordered in error by Customer.

2. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation and associated reagents shall have the capability of performing as defined in the statement of work.

2.1.2. The desired instrumentation and associated reagent shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

2.1.3. The Contractor is required to provide a continuously stocked inventory of reagents, controls, and supplies required to ensure that patient care 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. 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.

2.1.4. 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.

2.2. 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) 5 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. MOU - The VA utilizes a Memorandum of Understanding (MOU) to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection.

2.2.4. ISA -Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections.

2.3. REAGENT MENU: Refer to Attachment B for desired reagent menu and estimated annual volumes. This solicitation uses a Brand Name or Equal Description of the product required. This permits prospective contractors to offer products other than those specifically referenced by brand name.

3. GENERAL REQUIREMENTS:

3.1.1. Ability to provide two primary analyzers for each site.

3.1.1.1. 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 may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

3.1.2. Operational Features: The instrumentation offered shall have the following:

3.1.2.1. The capability to automate preparation of Immunohistochemical (IHC) stains and In situ Hybridization (ISH)

3.1.2.1.1. Utilize optimized protocols, with user selectable options

3.1.2.1.1.1. Ability to increase incubation times

3.1.2.1.1.2. Ability to change temperatures.

3.1.2.1.2. Automate all baking and staining steps for IHC and ISH

3.1.2.1.3. Hold at least 35 ready to use reagent dispensers

3.1.2.1.4. Process at least 30 slides per run, allow for continuous access and have the ability to stain slides overnight

3.1.2.1.5. Ability to manage multiple stainers from one computer

3.1.2.1.6. Process IHC and ISH simultaneously.

3.1.2.1.7. Ability to barcode each slide with chemical and heat resistant labels

3.1.2.1.8. Ability to heat each slide according to defined protocol.

3.1.2.1.9. Ability to use polymer based detection systems.

3.1.2.1.10. Ability to perform deparaffinization.

3.1.2.1.11. Ability to have random access allowing slides to be added and/ or reagents to be added once in operation.

3.1.2.1.12. Ability to perform different types of antigen retrieval/unmasking on the unit.

3.1.2.1.13. Ability to perform counterstain of tissue sections on the unit.

3.1.2.1.14. Capability of reagent inventory tracking on the unit.

3.1.2.1.15. Capability of producing QC/QA reports.

3.1.2.1.16. Unit should be a floor model or vendor will provide appropriate stand for table top model.

3.1.2.1.17. Ability to allow other vendor products to be utilized on unit for detection of antigens or other gene products.

3.1.2.1.18. Maintenance should involve a minimal amount of user involvement. Vendor should provide document that demonstrates the maintenance requirements.

3.1.3. Technical Features: The reagents offered shall have the following:

3.1.3.1. Reagents and ancillary products necessary for the operation of the immunochemical stainers.

3.1.3.2. Wide range of antibodies to aid in the identification and diagnosis of malignant and non-malignant pathologic processes in fixed, paraffin embedded human tissue.

3.1.3.3. Vendor shall supply detection kit that is an indirect, biotin free system for detecting mouse IgG, mouse IgM and rabbit primary antibodies by identifying targets for immunohistochemistry (IHC) in sections of formalin-fixed, paraffin-embedded and frozen tissue using an automated slide stainer.

3.1.3.4. Detection kit should be able to detect antigens expressed at low levels

3.1.3.5. Vendor shall supply Kappa and Lambda DNA Probes for ISH staining.

3.1.3.6. Reagents should be ready to use on the analyzer with a minimum stability of 12 months for detection kits and 18 months for antibodies and stains.

3.1.3.7. Vendor shall supply “dummy” bar-code-labeled reagent containers that can be used to facilitate use of other vendor products on the unit for antigen or other gene product detection.

3.1.4. Hardware Features – The instrumentation shall have the following:

3.1.4.1. All monitors/screens will clearly display information in all light conditions.

3.1.4.2. A printer(s) that has the capability of printing instrument generated reports.

3.1.4.3. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc,). 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.

3.1.4.4. Analyzer utilizes windows operating software or another VA approved operating system. Vendor will complete and return the following attachments:

3.1.4.4.1. 6550 Pre-Procurement Assessment

3.1.4.4.2. Memorandum of understanding (MOU) and Interconnection Security Agreement (ISA) is required for external communications or troubleshooting connections.

3.1.4.4.3. ACL Communication Profile for external communications or troubleshooting connections.

3.1.5. Method Performance/Validation Requirements

3.1.5.1. Method Optimization shall be at the expense of the Contractor, shall include reagents, and be consistent with current College of American Pathologists (CAP) standards.

3.1.5.1.1. Optimization when switching to a new antibody or detection kit, should be a minimum of 5 samples, shall be run by the present and the proposed method. Studies shall be at the expense of the vendor.

3.1.5.2. For validation of a new antibody, a minimum of 20 samples shall be tested for each nonpredictive marker and a minimum of 40 samples shall be tested for each predictive marker. Studies shall be at the expense of the vendor.

3.1.5.3. Vendor should provide their proposed implementation plan.

3.1.6. Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the REQUIREMENTS CONTRACT.

3.1.7. Support Features-

3.1.7.1. 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.

3.1.7.2. Start-Up Reagents. The Contractor shall provide all reagents, consumable/disposable items, parts, and accessories 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: method comparison with current analyzer.

3.1.7.3. Training.

3.1.7.3.1. 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor.

3.1.7.3.2. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant; at least three advanced training slots per testing site for the life of the agreement should be provided. These slots will be available for use at any time during the agreement.

3.1.7.3.3. Unlimited on-site training should be available for training of new staff member, when instrumentation upgrades occur or when deemed necessary as a follow-up to troubleshooting of an instrument or staining issue.

3.1.7.4. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

Service Requirements 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 hour.

Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

Equipment repair response time shall be no more than hours.

Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

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.

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

2.4.6.4.1.7. Equipment repair service shall include one (1) relocation of equipment, for each participating facility, during the life of the agreement. This shall include labor, travel and validation support.

3.1.7.5. 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 REQUIREMENTS CONTRACT; however, it does refer to significant changes in the hardware operational capability.

3.1.7.6. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the REQUIREMENTS CONTRACT, as indicated, any and all ancillary support equipment to fully operate or place the analyzer within a laboratory as defined in these specifications, e.g. cabinetry or stands to support/house the analyzer, water systems (including consumable polishers, filters, etc.), 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, line conditioners, UPS and UPS Batteries etc.

3.1.7.7. 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.

3.1.7.8. 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.

3.1.7.8.1. The determination and description shall address the following:

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

3.1.7.8.1.2. Waste ignitability (Reference 40 CFR §261.21)

3.1.7.8.1.3. Waste corrosivity (Reference 40 CFR §261.22)

3.1.7.8.1.4. Waste reactivity (Reference 40 CFR §261.23)

3.1.7.8.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

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

3.1.7.8.1.7. Solid Waste (Reference 40 CFR §261.2)

3.1.7.8.1.8. Exclusions (Reference 40 CFR §261.4)

3.1.7.8.2. 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.

3.1.7.8.3. 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. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

3.1.7.8.3.14. pH

3.1.7.8.3.15. Flash point (to higher than 200F)

3.1.7.8.3.16. BOD; biochemical oxygen demand

3.1.7.8.4. 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

3.1.7.9. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the REQUIREMENTS CONTRACT. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

3.1.7.9.1. Upon award of a REQUIREMENTS CONTRACT, the transition period for the awarded REQUIREMENTS CONTRACT to have all equipment and peripherals installed and operational by December 1, 2018 or agreed upon date for Kansas City VA which is currently undergoing construction. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

3.1.7.9.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall project for the transition of all services under the awarded REQUIREMENTS CONTRACT including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations with a start date of December 1, 2018 or agreed upon date for Kansas City VA which is currently undergoing construction. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate REQUIREMENTS CONTRACT for cause under the Termination for Cause clause of the REQUIREMENTS CONTRACT.

3.1.7.9.3. On December 1, 2018 or agreed upon date for Kansas City VA which is currently undergoing construction, the awarded Contractor shall have full and sole responsibility for services under the awarded REQUIREMENTS CONTRACT.

3.1.8. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or REQUIREMENTS CONTRACT] 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 installation 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 any REQUIREMENTS CONTRACT at an effectiveness level of 90% or more.

3.1.8.1. 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.

3.1.8.2. 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 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.)

3.1.8.3. 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.

3.1.8.4. 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

3.1.8.5. 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.

3.1.8.6. During the term of the REQUIREMENTS CONTRACT, 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 shall be made by the COR to replace the malfunctioning equipment with new equipment. 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 agreement for equipment.

3.1.9. 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.

3.1.10. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer and appropriate decontamination prior to removal.

3.1.11. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

3.1.12. Prior to termination or completion of this REQUIREMENTS CONTRACT, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this REQUIREMENTS CONTRACT without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the REQUIREMENTS CONTRACT.

3.1.13. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the REQUIREMENTS CONTRACT or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the REQUIREMENTS CONTRACT or disposal or return of the IT equipment, whichever is earlier

3.1.14. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

3.1.14.1. Contractor must accept the system without the drive;

3.1.14.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

3.1.14.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

3.1.15. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

3.1.15.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

3.1.15.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or REQUIREMENTS CONTRACT.

3.1.15.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

Contract Security Language

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C.