36C26121Q0759.docx

36C26121Q0759

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.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C261-21-AP-2910

36C26121Q0759 07-28-2021 Moneque Rodriguez 808-539-1304 08-11-2021 3PM Hawaii Time Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) Network Contracting Office (NCO) 21 3375 Koapaka St. STE F250 Honolulu HI 96819 X Y 334516 1000 Employees N/A X Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Southern Nevada Health Care System 6900 N Pecos Road North Las Vegas NV 89086 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) Network Contracting Office (NCO) 21 3375 Koapaka St. STE F250 Honolulu HI 96819

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Siemens Atellica Analyzer Cost Per Reportable Result (CPRR) The Government intend to negotiate a single award indefinite delivery/ indefinite quantity contract Ordering Period 1: Award Date to September 30, 2021 Ordering Period 2: October 01, 2021 - September 30, 2022 Ordering Period 3: October 01, 2022 - September 30, 2023 Ordering Period 4: October 01, 2023 - September 30, 2024 Ordering Period 5: October 01, 2024 - September 30, 2025 Ordering Period 6: October 01, 2025 - To be determined See CONTINUATION Page X Amanda Hildreth 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 36C261 Amanda Hildreth Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) Network Contracting Office (NCO) 21 3375 Koapaka St. STE F250 Honolulu HI 96819

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 FMS VA-9(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Statement of Work (SOW) : Immunoassay Testing July 20, 2021

1. Introduction

1.1 The VA Southern Nevada Healthcare System (VASNHS) Pathology and Laboratory Service located at 6900 North Pecos Road, North Las Vegas, Nevada 89086 has a requirement for a Cost Per Reportable Result (CPRR) services for automated Immunoassay testing. Pricing shall include installation, service, maintenance, training, and all necessary supplies needed for validation training.

2. Statement of Work

parameters as defined in the statement of work. The instrument shall be able to perform the complete profile as described below and 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).

2.1.2 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. 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 VA point of contact (POC). These individuals shall be identified upon award of the delivery order.

3.3 Instrumentation

3.3.1 Operational/Technical Features - The instrumentation offered shall provide the following capabilities:

minimal technician time.

VA information systems to report results.

3.3.1.7 Minimal daily maintenance, for example the analyzer is not required to be down for more than thirty (30) minutes per day. There shall be easy access to the analyzer for the technical operator to perform maintenance.

3.3.1.8 Must meet all FDA approval requirements for testing and all 1988 Clinical Laboratory Improvement Act/Clinical Laboratory Standards Institute guidelines.

Support Features

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

3.4.1.1 A technical assistance center shall be available by telephone twenty four (24) hours per day with a maximum call back response time of four (4) hours.

3.4.1.2 Equipment repair service shall be provided Five (5) Days a Week, Nine (9) hours a day.

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. If not providing a 24/7 plan, Contractor shall outline the cost of service calls outside normal working hours.

months unless otherwise stated within a deviation document.

3.4.1.5 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

Date and time notified Date and time of arrival Serial number, type and model number of equipment Time spent for repair, and Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

3.4.2 Training: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services.

This shall include training on the operation of the system, data manipulation, and basic trouble shooting 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.

If offered, the training program that involves off-site travel shall include the cost of airfare, room and board for each participant included in the cost per reportable result price.

3.4.3 Upgrade/Updates: The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc.

This does not refer to replacing the original piece of equipment; however, it does refer to significant changes in the hardware operational capability. A supplemental agreement may be included should the facility decide to upgrade their current equipment, i.e. replace existing equipment with newer models. agreement.

3.4.4 Characterization of hazardous waste: The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) Waste ignitability (Reference 40CFR261.21) Waste corrosivity (Reference 40CFR261.22) Waste reactivity (Reference 40CFR261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) The Contractor shall provide a written guide describing the proper disposal and care of all reagents, consumables and equipment.

The Contractor shall also provide their own reports of effluent studies associated with their instrument.

The Contractor shall also provide documentation to the VISN concerning any items in this acquisition that contain cyanide.

4.0 PACKAGING AND MARKING

Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

4.2 Marking

All items shall be marked clearly with identifying numbers and delivery location within the hospital ie. Pathology Lab.

5.0 DELIVERIES AND PERFORMANCE

described in this solicitation shall be completed no later than thirty (30) days after the award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the thirty (30) day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (ie.

construction/remodeling of facilities). Upon award, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be ten (8) days from the date of award through thirty (30) days.

5.1.2 At the end of 30 days from award of the Contract, the awarded Contractor shall have full and sole responsibility for services under the award.

5.2 Start-Up Reagents: The Contractor shall provide all reagents, calibrators, controls, consumable items, disposable items, parts, accessories and any other item included on the list of supplies.

The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as necessary, and report data in an organized, clearly comprehensible format.

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

5.2.3 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the government may request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4(m) entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

5.2.4 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.

5.2.5 During the performance period for a system, a minimum of 80 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 80 hours.

5.2.6 The Government will maintain daily records to satisfy the requirements of this paragraph 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.

5.2.7 Should the repair record of any individual piece of laboratory equipment reflect a downtime of 8% or greater of the normal working days in one calendar month, a determination shall be made by the designated representative of the Government 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.

5.2.8 The following products: supplies for the Atellica IM will be included:

5.3 Delivery: The Contractor shall deliver all supplies and services identified to:

VA Southern Nevada Healthcare System 6900 North Pecos Las Vegas, Nevada 89086 Room 2D326

5.3.1 The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The VA POC shall be required to notify the Contractor when delivery locations have been changed.

5.3.2 All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete delivery order number, obligation number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders shall be delivered within no more than 4 working days after receiving or placement of order. Emergency deliveries may be necessary on rare occasions. During these occasions, deliveries shall be made within one (1) working day if the order is place before 8:30 am. Otherwise, the emergency deliveries shall be made no later than two

(2) working days from the time the order was placed. Emergency deliveries shall be made at no additional cost to the government.

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

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

6.1 Payment Address: The Contractor shall submit in arrears (monthly or, otherwise as agreed upon) properly completed individual itemized invoices in accordance with FAR Part 52.232-34, Payment by Electronic Funds Transfer (Other than Central Offeror Registration) and VAAR Part 852.232-72 (or call 1-877-489- 6135 for questions) to the Department of Veterans Affairs, Financial Services Center. In addition, the Contractor shall be registered and submit all invoices via HTTP://WWW.TUNGSTENNETWORK.

COM/CUSTOMER-CAMPAIGNS/VETERANS-AFFAIRS-US/, unless otherwise instructed by the CO.

6.2 Invoice Information: The following information shall be listed on all invoice (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor).

6.2.1 Facility’s Name and address where service was provided

6.2.2 CONTRACT Number (For Example: 36C26120D0001)

6.2.3 Delivery Order Number (For Example: 36C26120N0001)

6.2.4 Obligation Number (For Example: 593-C00001)

6.2.5 A Line Item break down of usage for example:

6.2.5.1 Line item 1 CBC: 8 kt at $40.00 for a total of $400.00.

6.2.5.2 Line item 4 Retic CPT: 20 ea at $8.00

6.2.6 Include the period of time that is being invoiced for in the invoice.

6.2.7 Contract Holder’s Internal Contract number (if applicable)

6.2.8 Point of contact for concerns and questions. Must name a specific person, phone number and email.

Program Manager:

6.5. The Contractor shall provide a program manager who shall be responsible for the performance of the work under the contract. In addition, the program manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The program manager shall have full authority to act on behalf of the Contractor on all contractual/CONTRACT matters relating to daily operation of the contract.

Hours of Work

6.5.1 The award shall include five day a week, 9 hours a day full-service agreement to include all necessary service calls. After hours and weekends are chargeable as per Supplies or Service and Prices/Costs section herein, Schedule of Labor Charges and Replacement Parts. Contractor may offer differing times for the service agreement, but may not reduce the availability of time by no more than two hours from the above stated times.

6.5.2 Any service performed during other than normal work hours must be approved in advance by the authorized facility staff or CO.

6.5.3 Holidays. Only emergency service shall be provided on National Holidays and only if authorized by the authorized staff, in advance. The rates shall be chargeable as per Supplies or Service and Prices/Costs section herein, Schedule of Labor Charges and Replacement Parts.

When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

Physical Security and Facility Considerations:

Identification, Parking, Smoking and VA Regulations (For any onsite services)

6.6.1.1 The Contractor employees and/or Subcontractors approved by the authorized staff shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include but not be limited to a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor Employees shall maintain a professional appearance commensurate to their industry.

6.6.1.2 It is the responsibility of the Contractor to park in the appropriate designated parking areas.

Information on parking is available from the VA Police Section. The will not invalidates or make reimbursement for parking violations of the Contractor under any conditions.

6.6.1.3 Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit.

At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

6.6.1.4 Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the authorized VA staff. The Contractor's staff shall also be required to sign in and out each day at a designated location determined by the authorized VA staff.

6.6.1.5 The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government.

subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

6.6.1.8 The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

Background Checks

6.6.2.1 The Office of Security and Law Enforcement provides Department-wide policy on the assignment of appropriate position sensitivity designations associated with Department of Veterans Affairs (VA) positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions.

6.6.2.2 IAW VA 078 Handbook, appointees and contract personnel appointed to Low/Moderate/High Risk positions must be subjects of a background investigation conducted by OPM and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation has not been completed prior to contract commencement, the Contractor shall be responsible for the actions of those individuals performing under the contract.

6.6.2.3 Should the contract require Contractor’s personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, Contractor’s personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

6.6.2.4 The cost for such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government on the basis of the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof.

6.6.2.5 The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and social security number of the Contractor’s personnel. The VA will provide all the necessary instructions and guidance for submission of the documents required to conduct the background investigation. Background investigations shall not be required for contract personnel assigned to Low Risk/Non-sensitive positions for 180 days or less under a single contract or series of contracts. However, a Security Access Clearance (SAC) background screening will be required for appropriate preliminary checks IAW VA Directive 078.

6.6.2.6 Within 30 days of award, all contractors and members its servicing team that will provide service/maintenance, training or that will be on site for any reason related to the contract, shall complete VHA HIPPA and VA Privacy training. Training will be accomplished by establishing a VA TMS account, completing the assigned training and forwarding the certificate of completion to the COR that is identified on the contract.

7. INFORMATION SECURITY CONSIDERATIONS

7.1 Information and information system security/privacy language for inclusion into contracts as appropriate.

7.2 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.

7.3 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.

7.4 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 078, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness responsible for these policies and procedures.

7.5 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.

7.6 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.

7.7 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 SOUTHERN NEVADA ISSO POC: Freddie Cob Department of Veterans Affairs IT Operations and Services Phone:

Email address for POC:

8. Records Management.

8.1 Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

8.4 The VA Southern Nevada Healthcare System (VASNHS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VASNHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

8.5 In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

8.6 The contractor shall immediately notify the appropriate Contracting Officer (CO) upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract documents. The contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VASNHS control or the contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract documents. Destruction of records is expressly prohibited unless in accordance with Paragraph (4).

8.7 The contractor is required to obtain the CO'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, contracts. The contractor (and any sub-contractor) is required to abide by Government and VASNHS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

8.8 The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VASNHS policy.

8.9 The contractor shall not create or maintain any records containing any non-public VASNHS information that are not specifically tied to or authorized by the contract.

8.8 The 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 from public disclosure by an exemption to the FOIA.

8.11 VASNHS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VASNHS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

8.12 Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

8.13 Flow down of requirements to Subcontractors:

8.13.1 The contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract document, and require written subcontractor acknowledgment of same.

8.13.2 Violation by a subcontractor of any provision set forth in this clause will be attributed to the contractor.

Indefinite Delivery/ Indefinite Quantity (IDIQ) Minimum and Maximum The guaranteed minimum award amount for this contract is $2,000.00. The maximum aggregate value of orders that can be placed under this contract is $5,600,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Vitamin D (US) - Atellica IM for Annual Estimated Quantity 30,494 each PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11201772

Billing Material Number: 11192799 / Billing Material Description: CPR AIM Vitamin D 25-OH

Ferritin - Atellica IM for Annual Estimated Quantity 7,386 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192755

Billing Material Number: 11192755 / Billing Material Description: CPR AIM Ferritin

Fol - Atellica IM for Annual Estimated Quantity 15,842 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192756

Billing Material Number: 11192756 / Billing Material Description: CPR AIM Folic Acid

Vitamin B12 active - Atellica IM for Annual Estimated Quantity 16,401 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192966

Billing Material Number: 11192966 / Billing Material Description: CPR AIM Vitamin B12 Active

Alpha-Fetoprotein - Atellica IM for Annual Estimated Quantity 830 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192739

Billing Material Number: 11192739 / Billing Material Description: CPR AIM AFP

PSA - Atellica IM for Annual Estimated Quantity 17,131 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192782

Billing Material Number: 11192782 / Billing Material Description: CPR AIM PSA Total

CKMB - Atellica IM for Annual Estimated Quantity 577 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192747

Billing Material Number: 11192747 / Billing Material Description: CPR AIM CKMB Mass

TnI-Ultra - Atellica IM for Annual Estimated Quantity 10,819 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192796

Billing Material Number: 11192796 / Billing Material Description: CPR AIM Troponin I

BNP - Atellica IM for Annual Estimated Quantity 5,772 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192741

Billing Material Number: 11192741 / Billing Material Description: CPR AIM BNP

Homocysteine - Atellica IM for Annual Estimated Quantity 230 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192773

Billing Material Number: 11192773 / Billing Material Description: CPR AIM Homocystein

Testosterone II - Atellica IM for Annual Estimated Quantity 2,804 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192791

Billing Material Number: 11192791 / Billing Material Description: CPR AIM Testosterone II

Total hCG - Atellica IM for Annual Estimated Quantity 319 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192769

Billing Material Number: 11192769 / Billing Material Description: CPR AIM HCG Total

FSH - Atellica IM for Annual Estimated Quantity 866 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192759

Billing Material Number: 11192759 / Billing Material Description: CPR AIM FSH

LH - Atellica IM for Annual Estimated Quantity 805 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192776

Billing Material Number: 11192776 / Billing Material Description: CPR AIM LH

Prolactin - Atellica IM for Annual Estimated Quantity 805 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192800

Billing Material Number: 11192800 / Billing Material Description: CPR AIM Prolactin

CHIV (US) - Atellica IM for Annual Estimated Quantity 4,929 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192772

Billing Material Number: 11192772 / Billing Material Description: CPR AIM HIV Ag/AB Combo

HAV Total Ab (US) - Atellica IM for Annual Estimated Quantity 6,020 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192761

Billing Material Number: 11192761 / Billing Material Description: CPR AIM HAV Total Ab

HBsII - Atellica IM for Annual Estimated Quantity 6,371 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192768

Billing Material Number: 11192768 / Billing Material Description: CPR AIM HBs Ag

HBsII Ab- Atellica IM for Annual Estimated Quantity 6,187 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192766

Billing Material Number: 11192766 / Billing Material Description: CPR AIM HBs Ab

HCV Ab (aHCV) - Atellica IM for Annual Estimated Quantity 7,767 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192972

Billing Material Number: 11192972 / Billing Material Description: CPR AIM HCV Ab (US)

Cortisol - Atellica IM for Annual Estimated Quantity 578 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192748

Billing Material Number: 11192748 / Billing Material Description: CPR AIM Cortisol

HBcT - Atellica IM for Annual Estimated Quantity 5,953 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192763

Billing Material Number: 11192763 / Billing Material Description: CPR AIM HBc Total Ab

Rubella IgG - Atellica IM for Annual Estimated Quantity 292 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192784

Billing Material Number: 11192784 / Billing Material Description: CPR AIM Rubella IgG Ab

Syphillis - Atellica IM for Annual Estimated Quantity 2,633 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192787

Billing Material Number: 11192787 / Billing Material Description: CPR AIM Syphilis

FT3 - Atellica IM for Annual Estimated Quantity 1,726 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192757

Billing Material Number: 11192757 / Billing Material Description: CPR AIM Free T3

FT4 - Atellica IM for Annual Estimated Quantity 13,515 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192758

Billing Material Number: 11192758 / Billing Material Description: CPR AIM Free T4

PTH - Atellica IM for Annual Estimated Quantity 3,602 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192783

Billing Material Number: 11192783 / Billing Material Description: CPR AIM PTH intact

TSH3-UL - Atellica IM for Annual Estimated Quantity 36,144 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192797

Billing Material Number: 11192797 / Billing Material Description: CPR AIM TSH 3

CEA - Atellica IM for Annual Estimated Quantity 704 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 11192746

Billing Material Number: 11192746 / Billing Material Description: CPR AIM CEA

Vitamin D (US) - Atellica IM for Annual Estimated Quantity 30,494 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

Ferritin - Atellica IM for Annual Estimated Quantity 7,386 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

Fol - Atellica IM for Annual Estimated Quantity 15,842 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

Vitamin B12 active - Atellica IM for Annual Estimated Quantity 16,401 each

PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

Alpha-Fetoprotein - Atellica IM for Annual Estimated Quantity 830 each

PRODUCT/SERVIC…