36C25525Q0306_2.docx

36C25525Q0306

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

06-16-2025 Buchanan, Lisa A/lisa.buchanan1@va.gov 913-946-1990 07-08-2025

11:00 AM

CDT

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

Leavenworth KS 66048

X

334516 1000 Employees

N/A

Kansas City VA Medical Center

4801 East Linwood Boulevard Kansas City MO 64128 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 Kansas City VA Medical Center This is a solicitation to establish a Blanket Purchase Agreement for Kansas City VAMC for Cost -Per-Test (CPT) for Automated Antinuclear Antibody (ANA). The instruments will be on a lease agreement with the reagents being purchased.

This solicitation is unrestricted.

See Statement of Work, Schedule, Delivery and Attachment A for additional information.

All questions are due no later than June 23, 2025 at 10:00PM CST to Lisa Buchanan at lisa.buchanan1@va.gov.

Evaluation Criteria: Price, Technical Capability and Past Performance.

Contract award is subject to upper-level approval.

See CONTINUATION Page x

Buchanan, Lisa A Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C255 Buchanan, Lisa A/lisa.buchanan1@va.gov

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

Kansas City has the intent to establish a Cost-Per-Test (CPT) Blanket Purchase Agreement (BPA) for Automated Antinuclear Antibody (ANA). It is the intent of the Government to award a contract to a single contractor for Indirect Fluorescent Antibody (IFA) System and reagents. The reagents are required to perform specialized diagnostic testing on clinical patient specimens and must meet stringent quality control and compliance standards. Ordering of reagents will be done on an as need basis with shipments delivered within at least 5 business days. No minimum or maximum threshold will be in place. The quantity and type of reagents purchased cannot be predicted and is based on mission requirements during the performance period. The instruments will be on a lease agreement with the reagents being purchased.

Attachment A provides an estimated volume by test. Pricing is based on the AVERAGE daily test volume per instrument/analyzer. The volumes listed per facility in Attachment A, are estimates ONLY.

This will be a BPA with five ordering periods, the period of performance is 01/02/2026 - 1/1/2031.

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

The Contractor will be required to provide a continuously stocked inventory of:

· Reagents

· Standards

· Controls

· Supplies

· Disposables 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.

Any 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.

Ordering of reagents will be done on as needed basis with shipment delivered within at least 5 business days.

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 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.

The Contractor shall pay all shipping and handling fees for supplies.

The Contractor shall package reagents in such a manner as to ensure the integrity of the reagents during transport.

The Contractor shall explain their policy on replacement of unsuitable or damaged products or products shipped in error.

Vendor shall provide a VA acceptable itemized bill for all items shipped for payment with each shipment.

DEFINITIONS

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) 4 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.

GENERAL REQUIREMENTS

The contractor is required to maintain the equipment. All work shall be performed in accordance with the guidelines established by Federal, State, and local ordinances, FDA manufacturer’s guidelines, and with all terms, conditions, provisions, and specifications provide herein.

Vendor shall provide an Automated Indirect Fluorescent Antibody (IFA) slide processing and a digital immunofluorescence imaging system.

The Contractor must be a manufacturer of all listed products and reagents.

Vendor shall provide latest model/version of instrumentation. Refurbished or discontinued models are not acceptable.

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

Reagents, kits, and supplies:

The Contractor shall provide FDA approved Antinuclear Antibody products to include reagents, kits, supplies, and consumables used to perform patient testing slide stage instruments.

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

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

Unexpected changes in methodology/technology shall be at the expense of the contractor.

The contractor shall state the open date stability for the reagents for room temperature, refrigeration and frozen.

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

The Contractor shall inform the Serology Laboratory Supervisor of any reagent recalls or bulletins due to product unavailability due to manufacturing issues.

Data Management System:

Must be able to interface with VistA via Data Innovations Instrument Manager Shall be capable of maintaining all data and if interfaced, retransmit data for up to 24 hours in the event of normal electrical power interruptions via battery backup.

Shall have a built-in quality control program to regularly monitor performance of vital components.

Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk).

Shall have sufficient memory to store patient information and test results for 10,000 records with downloading capability to an external medium for long term storage of patient records and other information.

Hardware Features – The instrumentation shall have the following:

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

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

A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession number or unique identifier number (UID).

An uninterruptible power supply with line conditioner for each instrument provided, including replacement of batteries.

Ancillary support equipment:

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

Method Validation Requirements:

The Contractor shall assist each site in the performance all comparison and validation studies to include any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, The Joint Commission standards, CAP standards, and Federal Regulations.

Implementation/transition timeframe:

Need validation of equipment completed validated 90 days before final award.

The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after award. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

Upon award the transition period for the awarded BPA to have all equipment and peripherals installed and operational by January 2, 2026. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

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 BPA 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 January 2, 2026. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

Equipment relocation: In the event of moving the new equipment to a new location (such as a new laboratory, final destination), the contractor shall:

Move contracted lab equipment from the current location to the new lab space.

Assist with instruments’ validations after relocation.

Support Features:

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.

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

Training:

Upon Installation: The Contractor shall provide advanced (key operator) instrument training program for at least three operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair.

Thereafter: The Contractor shall provide training for minimally one operator 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.

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 1 hours.

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 24 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.

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

Upgrades: The Contractor shall provide upgrades to both the equipment hardware and software 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 BPA; however, it does refer to significant changes in the hardware operational capability.

Interface Requirements: The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A).

Shall be capable to connect and integrate results through a middleware system Work with the Laboratory Information Managers to interface the middleware system with vendor provided instruments.

Provide remote or onsite guidance on validation techniques and assist troubleshooting.

The Contractor shall provide all necessary software support ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. Lantronix box, licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 15:

MDS2 - Manufacturer Disclosure Statement for Medical Device Security.

VA Directive 6550 Appendix A- Pre-Procurement Assessment ACL Communication Profile 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.

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.

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) 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.

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:

· pH

· Flash point (to higher than 200F)

· BOD; biochemical oxygen demand 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.

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 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 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 BPA at an effectiveness level of 90% or more.

If 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.

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.)

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.

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.

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.

During the term of the 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.

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.

Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA 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 BPA.

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 BPA 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 BPA or disposal or return of the IT equipment, whichever is earlier.

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:

Contractor must accept the system without the drive;

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

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;

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;

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 BPA.

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.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY language FOR Inclusion into CONTRACTS 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.

ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS 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.

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.

VA Information Custodial Language:

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).

If VA determines that the contractor has violated any of the information confidentiality, privacy, security, and other 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.

Security Incident Investigation:

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

SS associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the but with respect to unsecured protected health information, the businesses associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

Liquated Damages For Data Breach:

Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

Each risk analysis shall address all relevant information concerning the data breach, including the following:

· Nature of the event (loss, theft, unauthorized access);

· Description of the event, including:

· date of occurrence;

· data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

· Number of individuals affected or potentially affected;

· Names of individuals or groups affected or potentially affected;

· Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

· Amount of time the data has been out of VA control;

· the likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

· Known misuses of data containing sensitive personal information, if any;

· Assessment of the potential harm to the affected individuals;

Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $__37.50__ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

Notification:

One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

Data breach analysis;

Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

One year of identity theft insurance with $20,000.00 coverage at $0 deductible;

Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

Training:

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

Successfully complete the appropriate VA privacy training and annually complete required privacy training (See below training); and Successfully complete any additional cyber security or privacy training, as required for A personnel with equivalent information system access The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

Additional Requirements:

The COR is responsible for coordinating with the Police prior to contractor arrival to identify the names of contractor personnel so that Police can ensure sufficient number of contractor badges are available for issuance prior to beginning work. COR is also responsible for signing out and signing in temporary contractor badges.

The COR is also responsible for maintaining copies of signed Privacy training for all contractors according to RCS 10-1.

Any work performed outside of official VA business hours after hours will require escorts.

Escort duties for un-cleared contractors are strictly limited to government officials, specifically VA employees. At no time are contractors allowed to escort other contractors.

Hours of Operation:

· Normal hours of coverage are Monday through Friday, 7:00 AM to 3:30 PM Central Standard Time excluding national holidays.

· Vendor on-site visits will be coordinated with the KCVAMC Laboratory Manager POC before being scheduled or conducted.

· Vendor representatives will check in with the KCVAMC Laboratory Manager POC when they arrive on-site and check out upon completion of work each day.

· All services shall be performed during normal hours unless otherwise scheduled with the KCVAMC Laboratory Manager POC.

· Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center.

· Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes removal of packaging and a clean sweep/mop of the area as required by work type.

· Vendor staff shall minimize noise as much as possible while working in all buildings.

· Vendor is responsible for providing all PPE necessary for their work.

Note: Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the KCVAMC Laboratory Manger POC).

Delivery:

· Vendor shall deliver leased equipment within 120 business days of receiving completed Contracting package from the VISN 15 Contracting Officer. If delivery delays occur vendor shall notify the Contracting Officer and the KCVMAC Laboratory Manger POC.

· Delivery will be to one of the two VA Saint Louis Health Care System main campuses. Vendor shall coordinate exact delivery location with the Contracting Officer and KCVAMC Laboratory Manager POC at the time of the purchase.

· Vendor will ensure that equipment is sent to the Attention of Laboratory Manger and will include the KCVAMC PO Number on the shipping label.

· Delivery of oversized, palletized orders or orders that contain a large number of components will be coordinated with KCVAMC Laboratory Manager POC who will communicate internally with Warehouse Staff.

KCVAMC Delivery Location

Kansas City VA Medical Center 4801 East Linwood Boulevard Kansas City, MO 64128 ATTN: Laboratory Manager PO Number for Order

Contract Administration Data:

All contract administration functions will be retained by the Department of Veterans Affairs.

The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

Contracting Officer’s Representative Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer, the designated representative for this contract will be determined at award.

Acronyms and Definitions CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance.

CLIN: Contract Line-Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item.

CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

COR: Contracting Officer’s Representative. An individual, including a Contracting Officer’s Representative (COR), designated and authorized in writing by the contracting officer to perform specific technical or administrative functions.

QA: Quality Assurance. Actions taken by the government to assure contracted services meet PWS requirements.

Personnel Non-Personal Services This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service s performing services herein. Such contract service s shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

Contractor Compliance with the Immigration and Nationality Act of 1952 The Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

Hours of Operations Business hours for the VAMC follow:

a. Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

b. National Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Juneteenth Independence Day Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

(c.) Off-Duty hours: Friday through Monday, 4:30 p.m. - 8:00 a.m.; Monday through Thursday, 4:30 pm – 8:00 am.

Quality Control:

CONTRACT PERFORMANCE MONITORING. The COR may perform surveillance of services by any of the methods listed below:

a. Observing actual performance;

b. Inspecting the services to determine whether or not the performance meets the performance standards; and

c. Review of any other appropriate records.

(1) When unacceptable performance occurs, the COR shall inform the Contractor and the Contracting Officer.