RFQ 36C25724Q0458.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

671-24-2-121-0332

36C25724Q0458 03-19-2024

Joe Miller 210-608-4773 03-25-2024

11:00 CDT

36C257

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

X

325413

1250 Employees

N/A

X

36C671

Department of Veterans Affairs

South Texas VA Health Care System

Laboratory

7400 Merton Minter Blvd.

San Antonio TX 78229-4401

36C257

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

Please see Section B for Statement of Work and Price/Cost

Schedule. Price Schedule must be completed and submitted with proposal.

See pages 50-51 for Instructions to Offerors and the provision at 52.212-2 on pages 51-52 for evaluation criteria

Vendors are to accept or concur with the technical factors;

otherwise, the proposal will be considered non-responsive.

See CONTINUATION Page

X X

X 1

Michael Tusinger

Branch Chief

36C25724Q0458

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.3 PRICE/COST SCHEDULE ......................................... Error! Bookmark not defined.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEC 2023) (DEVIATION) (JAN 2024)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.8 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN

2023) (DEVIATION)

C.9 VAAR 852.208-71 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTOR COMMITMENTS-ORDERS AND

BPAS (JAN 2023) (DEVIATION)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 44

C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

E.5 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

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

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

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 36C257

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] As Needed

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.

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

Statement of Work

SCOPE:

The South Texas Veteran’s Health Care System (STVHCS) has a need for a Cost per Test agreement for Automated Fecal Immunochemical Testing (FIT). The FIT is an automated assay for the detection of Hemoglobin in the feces from the colon and rectum that eliminates the need for patient dietary restrictions. As part of the Cost Per Test agreement the contractor shall provide two analyzers and all reagents, supplies and service/maintenance as part of a cost per test agreement. The contractor shall perform to the standards in this contract.

Location:

This cost per test agreement will be used in the Core Laboratory located in the Pathology and

Laboratory Medicine Service’s San Antonio Laboratories of the STVHCS.

Period of Performance:

Five Year IDIQ Contract with Five Ordering periods.

Deliverables/Supplies:

The following is required per the cost per test agreement for FIT testing a standing order will be established upon award:

• 2 Automated FIT instrumentations

• Service/Maintenance for 2 instrumentations

• All controls, calibrators

• All reagents and supplies

• 2 Utility Power Supply (UPS)

• Mailers that include the following:

o Patient sample label for patient to write full name, full social security number and date of birth.

o FIT testing device.

o Paid shipping label.

1. GENERAL REQUIREMENTS:

1.1. The vendor(s) shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to the STVHCS facilities.

1.2. Assessment of test volumes and testing needs shall be done on a yearly basis to account for patient increases.

1.3. Estimated yearly quantities as listed in the IGCE estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum.

1.4. Vendors shall provide each participating facility with Food and Drug

Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators/standards, mailing system for mailing/transport, disposables, and any consumable part necessary for analyzing/testing. Vendor shall list the consumable parts provided. Vendor shall state any parameter/function that is pending FDA approval at the time of this contract submission.

2. SYSTEM REQUIREMENTS:

1.1. The Automated Fecal Occult Blood Analyzer shall be capable of producing accurate and reproducible results on fecal specimens by established in vitro immunochemical diagnostic methods. Models shall provide accurate test assay results for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

1.2. Model must be capable of specifically detecting human hemoglobin, thereby removing the need for dietary restrictions and the collection and testing of more than one sample. Vendor to provide documentation supporting these claims.

1.3. Model must include a specimen transport system that is stable for a minimum of 14 days at ambient temperature for those specimens collected in the home setting, at community-based outpatient clinics and remote sites requiring an extended transport time. Vendor to provide manufacturer verified documentation of sample stability for a minimum of 14 days.

1.4. Vendor to provide mailing system for specimen transport that meets the US Postal

Service mailing requirements. Mailing system must be easy to use and include but not limited to specimen collection and labeling instructions, specimen transport tube/vial/card, and mailing envelop. Vendor shall work with each facility to develop an acceptable system to meet the needs for postage and addressing mailing envelops of that facility.

1.5. Vendor shall specify calibration frequency and time required to perform calibration.

1.6. Vendor to provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements. Vendor to specify requirements for frequency of quality control testing.

1.7. Analyzer shall have the capability of providing printouts for all patient results, calibrators, and controls.

1.8. All consumable supplies (reagents, standards, controls, disposable, etc…) required for the proper operation of the contractor’s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the contractor for each Fecal Occult Blood Immunoassay analyzer.

1.9. The contractor shall maintain at each facility a continuously stocked inventory of shipping supplies/containers, reagents, standards, controls, supplies, disposables, and any other material required to properly perform tests on the offered equipment.

These items shall be of the highest quality ensuring sensitivity, specificity, and have been previously tested to assure their precision and accuracy. The quality of the products shall be within the acceptable proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

1.10. The system shall have a design that supports the result integrity/removes the possibility of sample carryover. Vendor shall provide documented evidence confirming the system design removes the possibility of any sample carryover.

1.11. The vendor shall state the on-board reagent stability.

1.12. The vendor shall list all reagents and quantities needed for Fecal Occult Blood

Immunoassay testing, state if the reagents are stored at room temperature or refrigerated and state the format/size of reagents.

1.13. The vendor is to define the actual hands-on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The vendor is to include the analyzer/technologist time required to perform each maintenance task. The vendor shall list which tasks are user level and which tasks are service level.

1.14. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50- and 90-degrees Fahrenheit (10 to 30 degrees Celsius).

3. SUPPORT SYSTEMS (SERVICE, PREVENTATIVE MAINTENANCE AND SHIPPING OF

SUPPLIES)

3.1. Vendor will provide technical support services at no additional charge to all STVHCS facilities. Technical support by telephone shall be available 7 days a week, 24 hours a day. Technical support shall return all downtime calls within one hour. Should on-site service be required, the contractor’s field service organization shall provide on-site service response within 24 hours after being contacted. All replacement instrument/equipment must be received within 24 hours from the time the on-site service arrives. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed.

3.2. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of troubleshooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facilities staffing.

3.3. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs.

3.4. Requests for services will be through one contractor.

3.5. The vendor shall provide instrument support service sufficient to aid with troubleshooting and repair of the analyzer. The vendor may list their service options available. Or the following service option may be available: 24 hours/day, 7 days/week basis for hospitals, and 5 days/week basis for clinics. The support service shall follow-up all down calls within 1 hour. The FSR always shall keep the facility/clinic informed of the timeline for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility/clinic) within 24 hours from the time the field service engineer arrives.

3.6. If the consumables are found to be defective and unsuitable for use with the vendor's equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the

Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting STVHCS facility 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 will be honored by the vendor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory will result in default.

3.7. Frequency of shipments. Vendor will provide initial inventory based on expected use, then establish a standing weekly/monthly/quarterly shipment based on current use, with the capacity to fill emergency requests on demand.

3.8. Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing and will pay for shipping for volume adjustments should additional supplies be required.

3.9. The vendor must provide replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results.

4. TRAINING AND PROCEDURES:

4.1. Vendor must provide all education/training on site during installations or update to the equipment. Training to include staff on all shifts. Training must include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site.

4.2. Provide initial in-depth training for two key operators at each site and annual training for one VA equipment operator, per participating VISN 17 Medical Center. Key operator training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. The vendor shall provide on-site refresher instrument training in renewal option years of the contract if so exercised.

4.3. Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and MSDSs (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Vendor must aid in creating preventive maintenance and quality control records or logs to meet the needs of the facility.

5. Data/Instrument Management System and required hardware:

The data and instrument management system must incorporate the minimum requirements:

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

• Patient status display for technologist review and workflow management for all integrated testing instrumentation.

• Ability to retransmit patient records to universal interface system in case of interface outage.

• Technology to automatically repeat testing based on customer configurable testing criteria.

• Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

• Contractor must collaborate with lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

• Contractor must assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

• Hardware must meet the following requirements:

o Total equipment footprint, when installed in the laboratory must not impact the functionality/operations of laboratory.

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

o Printer(s) that have the ability of printing a patient report automatically with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID). Contractor is responsible for maintain and replacing

Printers.

o 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. Contractor is responsible for maintaining and replacing UPS systems provided.

• The Contractor is responsible for providing all hardware, software and ancillaries 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.

• The Contractor must provide all necessary software support for 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. If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g., 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 and any hardware/software replacements needed to accomplish this task.

1) Interfacing requirements to be provided by the vendor:

• A bi-directional, bar-coded computer interface with ability to read standard barcode format such as Code 128 and Code 39. The fully operational interface

(both hardware and software) must be immediately available for implementation to the VA VistA hospital information system (Refer to Brief Summary of VistA

Functionality below) at the time of contract award. If the host system software requires the use of non-proprietary universal interfacing system to provide bi-directional interfacing capabilities using Data Innovations systems. To achieve connection with those systems, the awarded vendor will be responsible for the cost of the interface including hardware and software. Refer to the following section entitled “Support Features – Computer Interfacing Requirements” for specific details.

• Brief Summary of VistA Functionality

VistA is a public domain system to the VA whose functionality includes:

• Management of patient information through a database,

• Acceptance of test ordering information,

• Transmittal of patient laboratory test results.

• Storage and retrieval of patient laboratory test results.

(VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an instrument maintenance program.)

6. Middleware System-

Interface must be compatible with Data Innovations and Cerner.

• Instrument connection to middleware service must be provided.

• Vendor must provide onsite and remote support as needed for installation and duration of the contract.

7. Inherently Governmental Functions:

The contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

8. Contractor Security Contract Requirements:

This contract is for test kits, supplies, and the leasing of equipment, service and maintenance and all ancillary supplies needed for the equipment or printers. The Contractor does not require access to any VA Information System or any routine access to any STVHCS laboratory.

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:

The contractor will have access to protected Patient Health Information (PHI) but will not have the capability of accessing patient information during the services provided to the VA.

Contractor is required to be in compliance with the American Association of Blood Banks

(AABB) and College of American Pathologists (CAP) accreditation policies and all applicable

Federal, State and Government laws.

Records Manager:

There will be federal records created, maintained, used, or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY

REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format

(e.g., paper, microfiche, electronic or magnetic portable media).

b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security

Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

STX-HCR671-04 General Information Security Requirements /Records

1.1. All information and records provided to Contractor by VA, in whatever medium, as well as all information and documents, including drafts, emails, back-up copies, hand-written notes and copies that contain such information and records gathered or created by Contractor (collectively referred to as “VA information”) in the performance of this contract, regardless of storage media, are the exclusive property of VA. Contractor does not retain any property interest in these materials and will not use them for any purpose other than performance of this contract.

1.2. Upon completion or termination of the contract, Contractor will either provide all copies of all VA information to VA or certify that it has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA’s option. Medical records of any kind including notes shall be returned to the VA. The Contractor will not retain any copies of VA information. Where immediate return or destruction of the information is not practicable, Contractor will return or destroy the information within 30 days of completion or termination of the contract. All provisions of this contract concerning the security and protection of VA information that is the subject of this contract will continue to apply to VA information for as long as the Contractor retains it, regardless of whether the contract has been completed or terminated.

1.3. Prior to termination or completion of this contract, Contractor will not destroy VA information received from VA or gathered or created by Contractor in the course of performing this contract without prior written approval by VA.

1.4. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of

VA information only in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations, and policies.

1.5. The Contractor shall not make copies of VA information except as necessary to perform this agreement or to preserve electronic information stored on Contractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor needs to be restored to an operating state.

1.6. Contractor shall provide access to VA information only to employees, subcontractors, and affiliates only: (1) to the extent necessary to perform the services specified in this

Contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable.

1.7. Contractor will store, transport, or transmit VA information only in an encrypted form, using an encryption application that meets the requirements of FIPS 140-2, and is approved for use by VA.

1.8. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two other situations: (i) in response to an order of a court of competent jurisdiction, or (ii) with VA’s prior written authorization. The contractor will refer all requests for, demands for production of, or inquiries about, VA information to VA for response.

1.9. If VA information subject to the contract includes information protected by 38 USC

7332, or 5705, include the following after the last sentence of the paragraph immediately above: Contractor shall not release information protected by either 38

USC 5705 or 7332 in response to a court order, and shall immediately refer such court orders to VA for response.

1.10. Prior to any disclosure pursuant to a court order, the Contractor shall promptly notify

VA of the court order upon its receipt by the Contractor, provide VA with a copy by fax or email, whichever is faster, and notify by telephone the VA individual designated in advance to receive such notices. If the Contractor cannot notify VA before being compelled to produce the information under court order, the Contractor will notify VA of the disclosure as soon as practical and provide a copy of the court order, including a copy of the court order, a description of the records provided pursuant to the court order, and to whom the Contractor provided the records under the court order. The notice will include the following information to the extent that the Contractor knows it, if it does not show on the face of the court order: the records disclosed pursuant to the order, to whom, where, when, and for what purpose, and any other information that the

Contractor reasonably believes is relevant to the disclosure. If VA determines that it is appropriate to seek retrieval of information released pursuant to a court order before

Contractor notified VA of the court order, Contractor will assist VA in attempting to retrieve the VA information involved.

1.11. The Contractor will inform VA by the most expeditious method available to Contractor of any incident of suspected or actual access to, or disclosure, disposition, alteration, or destruction of, VA information not authorized under this Contract (“incident”) within one hour of learning of the incident. An incident includes the transmission, storage, or access of VA information by Contractor or subcontractor employees in violation of applicable VA confidentiality and security requirements. To the extent known by the

Contractor, the Contractor’s notice to VA will identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the

VA information was placed at risk or compromised), and any other information that the contractor considers relevant.

1.12. Contractor will simultaneously report the incident to the appropriate law enforcement entity of jurisdiction. The Contractor, its employees, and its subcontractors and their employees will 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 also will cooperate with VA in any civil litigation to recover VA information, to obtain monetary or other compensation from a third party for damages arising from any incident, or to obtain injunctive relief against any third party arising from, or related to, the incident.

1.13. VA will provide the Contractor with the name, title, telephone number, fax number and email address of the VA official to whom the Contractor will provide all notices required by this Contract.

1.14. VA has the right during normal business hours to inspect the Contractor’s facility, information technology systems and storage and transmission equipment, and software utilized to perform the contract to ensure that the Contractor is providing for the security of VA data and computer systems in accordance with the terms of this

Contract.

1.15. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of

VA information only in compliance with all applicable Federal Information Processing

Standards (FIPS) and Special Publications (SPs) issued by the National Institute of

Standards and Technology (NIST) concerning VA information that is the subject of this contract. If NIST issues or updates an applicable FIPS or SP after execution of this contract, the parties agree to negotiate in good faith to implement the FIPS or SP in this contract.

1.16. A determination by VA that the Contractor has violated any of the information confidentiality and security provisions of this contract, including a violation of any applicable FIPS or SP, shall be a basis for VA to terminate the contract for cause.

1.17. If anyone performing this contract, including employees of subcontractors, accesses

VA computer systems or data in the performance of the contract, VA may monitor and record all such access activity. If VA monitoring reveals any information of suspected or potential criminal law violations, VA will refer the matter to the appropriate law enforcement authorities for investigation.

1.18. Contractor shall inform its employees and other individuals performing any part of this contract that VA may monitor their actions in accessing or attempting to access VA computer systems and the possible consequences to them for improper access, whether successful or not. The Contractor shall ensure that any subcontractors or others acting on behalf of, or for, the Contractor in performing any part of this contract inform their employees, associates or others acting on their behalf that VA may monitor their access activities. Execution of this contract and any subcontract or agreement constitutes consent to VA monitoring.

1.19. The Contractor will ensure that all individuals who will access VA data or systems in performing the contract are appropriately trained in the applicable VA confidentiality and security requirements. Contractor may do this by requiring and documenting that these individuals have completed the VA training for its employees.

1.20. To the extent practicable, Contractor shall mitigate any harmful effect on individuals whose VA information was accessed or disclosed in an incident.

1.21. Contractor shall require subcontractors, agents, affiliates, or others to whom

Contractor provides access to VA information for the performance of this contract to agree to the same VA information confidentiality and security restrictions and conditions that apply to the Contractor before providing access.

1.22. The contractor shall abide by FAR clauses 52.224-1 and 52.224.2.

1.23. The contractor shall abide by FAR clauses 52.239-1 and 52.224.1-2 for Privacy or

Security Safeguards

1.24. In the performance of any part of the work on this contract, the contractor shall utilize only employees, subcontractors or agents who are physically located within a jurisdiction subject to the laws of the United States. Contractor will ensure that it does not use or disclose Patient Health Information (PHI) received from Covered Entity in any way that will remove the PHI from such jurisdiction. Contractor will ensure that its employees, subcontractors, and agents do not use or disclose PHI received from

Covered Entity in any way that will remove the PHI from such jurisdiction.

VA Handbook 6500.6 Appendix C Paragraph 2 - ACCESS TO VA INFORMATION AND VA

INFORMATION SYSTEMS

1.25. 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.

1.26. 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.

1.27. 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.

1.28. 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.

1.29. 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 Handbook 6500.6 Appendix C Paragraph 6 - SECURITY INCIDENT INVESTIGATION

1.30. 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.

1.31. 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.

1.32. With respect to unsecured protected health information, the business 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 business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

1.33. 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.

VA Handbook 6500.6 Appendix C Paragraph 9 - TRAINING

1.34. 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:

1.34.1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

1.34.2. Successfully complete the VA Cyber Security Awareness and Rules of

Behavior training and annually complete required security training.

1.34.3. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

1.34.4. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

1.35. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

1.36. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, 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 the training and documents are complete.

NARA RM Language Clause to be included in contracts, as necessary:

1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR

Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the

RCS 10-1.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the

Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the

Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by

Government and Agency guidance for protecting sensitive and proprietary information.

References:

VHA Directive 6300

VA Handbook 6300.1

South Texas VA Medical Center Policy

VA Directive 6500

36 CFR Part 1222.32 (b)

VHA Handbook 1106.1

This is a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ)

Contract.

The guaranteed minimum award amount for this contract is $4,250.00. The maximum aggregate value of orders that can be placed under this contract is $425,000.00. The

Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

Ordering Period:

POP Begin: 4/01/2024

POP End: 3/31/2029

DELIVERY – South Texas VA Health Care System

South Texas VA Health Care System (STVHCS)

Pathology & Laboratory Medicine Service

7400 Merton Minter

San Antonio, Texas 78229

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

1.00 EA ________________

BASE + FOUR OPTION YEARS - COST-PER-

REAGENTS/CONSUMABLES FOR THE PERIOD OF

PERFORMANCE

Contract Period: Ordering Period 1 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: OCSIO

BASE + FOUR OPTION YEARS - COST-PER-

REAGENTS/CONSUMABLES FOR THE PERIOD OF

PERFORMANCE

6,000.00 EA ________________

COST-PER-REAGENTS/CONSUMABLES: ITEM #VA-CPT1

- COST PER TEST (1DEVICE PER PATIENT

REPORTABLE), QTY 6000

Contract Period: Ordering Period 1 POP Begin: 04-01-2024 POP End: 03-31-2025

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: VA-CPT1

COST-PER-REAGENTS/CONSUMABLES: ITEM #VA-CPT1

- COST PER TEST (1DEVICE PER PATIENT

REPORTABLE), QTY 6000

216.00 EA ________________

COST-PER-REAGENTS/CONSUMABLES: INCLUDED IN

CPT: ITEM # DESCRIPTION: OCIOL OC Sensor iO Latex reagent(2x100) - QTY 36 OCIOC OC-Sensor IO Calibration Kit(10x1ml, 2x45ml Diluent) - QTY 12 OCIOB OC-Sensor IO Buffer 200 ml(660 tests per bottle) - QTY 12 OCQN OC-Sensor IO Negative Control (5x 1ml) - QTY 12 OCIOQP OC-Sensor IO Positive Control (5x 1ml) - QTY 12 OCIOW OC-Sensor IO Wash Solution (1x120ml) - QTY 36 OC80CUV OC-Auto Micro 80 cuvettes(1x100) - QTY 72 TT- 88 OC-Auto Micro 80 Instrument Cups(2 bags of 500) -

QTY 24

Contract Period: Ordering Period 1 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: CPT

COST-PER-REAGENTS/CONSUMABLES: INCLUDED IN

CPT: ITEM # DESCRIPTION: OCIOL OC Sensor iO Latex reagent(2x100) - QTY 36 OCIOC OC-Sensor IO Calibration Kit(10x1ml, 2x45ml Diluent) - QTY 12 OCIOB OC-Sensor IO Buffer 200 ml(660 tests per bottle) - QTY 12 OCQN OC-Sensor IO Negative Control (5x 1ml) - QTY 12 OCIOQP OC-Sensor IO Positive Control (5x 1ml) - QTY 12 OCIOW OC-Sensor IO Wash Solution (1x120ml) - QTY 36 OC80CUV OC-Auto Micro 80 cuvettes(1x100) - QTY 72 TT- 88 OC-Auto Micro 80 Instrument Cups(2 bags of 500) -

QTY 24

2.00 EA ________________

COST-PER-REAGENTS/CONSUMABLES: ITEM #TTP-5 -

THERMAL PAPER (2 PER YEAR) - 5 ROLL PER BOX, QTY

Contract Period: Ordering Period 1 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: TTP-5

COST-PER-REAGENTS/CONSUMABLES: ITEM #TTP-5 -

THERMAL PAPER (2 PER YEAR) - 5 ROLL PER BOX, QTY

756.00 EA ________________

COST-PER-REAGENTS/CONSUMABLES: ITEM #OCPUIO-

VA1 Personal Mailer (1 device per mailer/20 box), QTY 756 Contract Period: Ordering Period 2 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: OCPUIO-VA

COST-PER-REAGENTS/CONSUMABLES: ITEM #OCPUIO-

VA1 Personal Mailer (1 device per mailer/20 box), QTY 756

BASE + FOUR…