36C25020Q0070-001.docx

36C25020Q0070

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

583-20-1-057-0002 36C25020Q0070 11-14-2019 Andrea J. McKinney 734-222-4362 11-20-2019 1:00p.m. EST 00250 Department of Veterans Affairs Network Contracting Office 10 24 Frank Lloyd Wright Drive Suite M2200 Ann Arbor MI 48105 X X 621511 $35 Million N/A X Department of Veterans Affair Richard L. Roudebush VAMC 1481 West 10th Street Indianapolis IN 46202 Y Department of Veterans Affair Network Contracting Office 10 24 Frank Lloyd Wright Drive Suite M2200 Ann Arbor MI 48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page See CONTINUATION Page 583-3600160-057-822300-2560 010022354 X Kristina L. Gandy 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:

Department of Veterans Affairs

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.

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

B.2 PRICE/COST SCHEDULE

Prostrate Cancer Testing Contract Period: Base POP Begin: 12-01-2019 POP End: 11-30-2020

Prostrate Cancer Testing Contract Period: Option 1 POP Begin: 12-01-2020 POP End: 11-30-2021

Prostrate Cancer Testing Contract Period: Option 2 POP Begin: 12-01-2021 POP End: 11-30-2022

Prostrate Cancer Testing Contract Period: Option 3 POP Begin: 12-01-2022 POP End: 11-30-2023

Prostrate Cancer Testing Contract Period: Option 4 POP Begin: 12-01-2023 POP End: 11-30-2024

B.3 STATEMENT OF WORK

Prostate Cancer Testing

1. Introduction: This acquisition is to perform specialized diagnostic testing for male prostate cancer for veteran clients. A base+4 contract is sought with base year being twelve (12) months from award date for the Richard L. Roudebush VA Medical Center (RLR VAMC) located at 1481 W. 10th Street, Indianapolis, IN 46202.

2. Background: Technology has progressed in this specimen test area to new methodology that forgoes initial and repeat biopsy samples. A genetic test process includes the test, analysis and result reporting. The test shall be urine based, molecular diagnostic test that offers a non-invasive 'liquid biopsy' method to assess a man's risk for prostate cancer and determine which patients can safely avoid a traditional biopsy. The test provides binary results that, when combined with the patient’s clinical risk factors, help the physician determine whether the patient may benefit from a biopsy and early prostate detection, or the patient can avoid a biopsy and return to routine screening.

3. Scope: The send-out tests covered under this contract consist of urine specimens collected from patients at the RLR VAMC. The Contractor shall provide commercial medical reference laboratory services. Services include all necessary qualified personnel, all laboratory services including the materials, equipment, and supplies to perform and report accurate and timely laboratory testing services to support the RLR VAMC.

4. Objective: The overarching goal of this initiative is to improve patient care and maximize cost effectiveness to the government by reducing unnecessary medical procedures (i.e. biopsies) to those not at an increased risk.

5. General DEFINITIONS for Laboratory Services

Contracting Officer (CO) –Individual(s) authorized to enter into, administer, and/or terminate contracts and make related determinations and findings. The term includes certain authorized representatives of the contracting officer acting within the limits of their authority as delegated by the contracting officer.

Contracting Officer’s Representative (COR) –A Federal employee who assists the ordering/issuing agency contracting officer in the administration of task orders issued under this contract. The COR is primarily responsible for the day-to-day program management of the ordering facility’s task or task order.

Routine Test –A test that is usually performed at high volume in which the result is generally required in 24 hours. The ordering facility turnaround times are itemized for each test required.

Specimen –A body urine fluid removed for medical examination and analytical testing.

Turnaround Time (TAT) –The length of elapsed time between pick-up or dispatch of specimen from the government ordering facility laboratory and the receipt of the completed printed report received by the government ordering facility laboratory. Exception: For STAT tests, the TAT shall begin at the time of notification by the ordering facilities laboratory to the contractor that the specimen is ready for pick-up. These definitions apply whether the contractor or a subcontractor performed the test.

6. Task: The Contractor shall provide medical laboratory testing and analysis services for the RLR VAMC. Specific task requirements are in the following paragraphs.

6.A.1: General Requirements:

6. A.1.1 The Contractor shall be responsible for performing preanalytic processing, analysis, and result interpretation for clinical specimens as requested by RLR VAMC. Services shall the contractor’s the performance of analytical testing as defined by the Contractor’s reference test manual, the reporting of analytical test results, and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility.

6.A.1.2 The contractor will provide a streamlined process to perform testing for prostate cancer.

6.A.1.3 Services to be furnished under this contract shall be ordered by issuance of a task order by the ordering facility for results to be delivered to the site designated via electronic transmission or fax on the task order and in accordance with standards, clauses, and provisions of this document.

6.A.1.4 The Contractor shall provide pre-paid specimen kits for transporting the samples in such a manner as to ensure the integrity of the specimen.

6.A.1.5 The Contractor shall ensure that employees providing customer services under this contract are able to read, write and speak English fluently, with sufficient clarity, to effectively communicate with personnel from the Government-owned laboratory when necessary.

6.A.2: Lab General Qualifications:

6.A.2.1 Licensing and Accreditation 6.A.2.1.1 The contractor shall be a fully licensed and accredited laboratory actively engaged in providing the specific services and laboratory testing. The contractor shall have all licenses, permits, accreditations, and certificates required by law. The reference laboratory shall be licensed and accredited by the College of American Pathologists (CAP) or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory shall be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

6.A.2.1.2 The Contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses and certificates to the Contracting Officer before expiration.

6.A.2.1.3 The Contractor shall ensure that all testing and supervisory personnel, including the Medical Director, assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the College of American Pathology (CAP) accreditation standards.

6.A.2.1.4 The Medical Director of the contracting facility shall be a licensed physician with suitable qualifications and experience to direct a laboratory in providing testing under this contract according to CLIA and CAP standards. The Contractor shall submit a copy of the professional certification and licensure of the Laboratory Director and Medical Director to the COR. Also copies of all certifications and licenses for the Technical Supervisors of the Primary Contractor’s laboratory shall be submitted with the proposal.

6.A.2.1.5 The Contractor shall provide a copy of all relevant permits, licenses, and certificates inclusive of any sanctions current or pending throughout the United States of America prior to contract award.

6.A.2.1.6 In addition, as appropriate, the Contractor shall be responsible for providing evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any subcontractors performing services hereunder shall meet the same requirements as the prime contractor. Proof of the above required certifications, accreditations, licenses, etc. shall be furnished to the COR. Any proposed subcontractor changes during the contract performance period shall have prior approval by the Contracting Office (CO). Changes to the requirements will be executed by a bilateral modification to the contract.

6.A.2.1.7 All laboratory testing services shall be rendered by individuals fully qualified by the Federal, State and local laws. The laboratory shall hold all legally required licenses, certifications, and accreditations in accordance with Federal statutes and implementing regulations and those of the state in which the laboratory is located. 6.A.2.1.8 Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). Neither the Contractor, nor any of its employees, will disclose private medical information concerning patients to third parties other than those personnel designated by the Government to receive patient results. Results will be handled as private medical records.

6.A.2.1.9 Client Service personnel shall be accessible by toll-free telephone to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, requesting emergency service, using the provided computer system, and other applicable related issues or problems that may arise in the performance of work under this contract.

6.A.2.1.10 The Contractor shall only conduct business with designated Government personnel listed as points of contact (POCs). Names of authorized personnel will be provided to the Contractor by the Government, in writing, and updated as necessary throughout the contract period.

6.A.2.1.11 The Contractor shall designate and submit in writing the name and telephone number of a full-time contract manager and alternate to the Contracting Officer. The contract manager will be responsible for the satisfactory performance of the required services. They will meet, as necessary, with the RLR VAMC COR or designee to discuss immediate administrative, technical issues, and problem areas. The contract manager shall ensure all monthly invoices are reviewed for accuracy and delivered in accordance with the terms of this SOW. Verify that only tests performed are charged, based on the contracted Test Price Schedule.

6.A.2.3 Malpractice Liability Insurance 6.A.2.3.1 Malpractice liability insurance shall be furnished with a required insurance coverage of $1,000,000.00 per occurrence. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate.

6.A.2.3.2 The Contactor shall notify the Contracting Officer in writing of any malpractice investigation, licensure, or certification suspension which relate to the Contractor or any employees within 24 hours of notification of an investigation or suspension.

6.A.2.5 Specimen Tracking System and Notification Processes:

6.A.2.5.1 The Contractor shall promptly notify the ordering facility of lost or missing specimens or amended reports within 24 hours of occurrence. A ten (10) business day notice shall be given to the ordering facility of any test changes via email or electronic communication.

6.A.2.5.2 Information to be provided by the Contractor includes:

6.A.2.5.2.1 Test specific specimen collection and preservation requirements for each test or analyte.

6.A.2.5.2.2 Test specific method and interpretation for each test or analyte.

6.A.2.5.2.3 Test specific method reference ranges, adjusted for age, sex, or race, when required.

6.A.2.5.2. Test specific method sensitivity and specificity, when required.

6.A.2.5.2.5 Test specific schedule of performance and maximum turn-around-time for each test.

6.A.2.5.2.6 Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units). In the event of any change, this information will be provided to the Government COR at least 10 business days prior to the Contractor’s change. Changes to procedures with less than 10 business days’ notice will be made only with the agreement of the COR.

6.A.2.5.2.7 In the event the Contractor changes the assay procedures or a critically important component of an assay, the Contractor shall notify the COT prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the Contracting Officer. The Contractor shall be liable for excess procurement costs.

6.A.2.5.2.8 The Contractor shall provide the status of pending test results upon inquiry providing the direct phone numbers to the specific lab area and the laboratory location performing the test.

6.A.2.5.2.9 The Contractor shall notify the ordering facility via phone within two (2) hours of problem identification in the instances mentioned below to allow the ordering facility’s send out technologist to decide the best course of action for the sample.

· The sample is too short to run

· The sample does not give results due to sensitivity issues with the currently used test method.

· If the sample testing is delayed due to the current platform testing being “down.”

· The sample is rejected per customer service.

· Adding/Canceling Testing 6.A.2.5.2.10 Contractor shall allow additional testing or "add-ons" to be ordered on specimens held in storage. Added tests are authorized via telephone with a follow-up faxed test request form. Contractor shall allow to cancel or change test request if necessary.

6.A.2.6 Procedure Guidelines 6.A.2.6.1 The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Contracting Officer (CO) or Contracting Officer’s Representative (COR), the Contractor will make available quality assurance information on specific testing procedures for review.

6.A.2.6.2 Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the Government unless otherwise indicated by the ordering facility’s authorized personnel.

6.A.2.6.3 The Contractor shall whenever applicable or relevant make a distinction between tests that are FDA approved vs. research only use (RUO), in vitro diagnostic (IVD), investigational use only (IUO), life science research (LSR), or Emergency use authorization (EAU). In such cases, the distinction shall be printed on each result sheet.

6.A.2.7 Supplies 6.A.2.7.1 The Contractor shall provide an electronic or paper laboratory user manual to include defined testing methodology and reference ranges for each test.

6.A.2.7.2 The Contractor shall provide all necessary supplies normally provided to its commercial customers, including to the following:

· Requisition forms

· Leak-proof plastic tubes and containers for routine shipment of diagnostic specimens.

· Special instructions

· Current list of tests with reference ranges and specimen requirements 6.A.2.7.3 The Contractor shall contact the COR within a maximum of five (5) business days after award of task order or Blanket Purchase Agreement, to coordinate the furnishing and delivery of specimen collection and transportation, furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and transshipping transport containers necessary to meet the requirements established under the terms of this contract.

6.A.2.8 Test Results 6.A.2.8.1 The results shall be via fax in accordance with the testing specifications defined in the Contractor’s commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day).

6.A.2.8.2 Routine Testing The Contractor shall provide routine test results to the ordering facility in accordance with the testing specifications defined in the Contractor’s commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). Test procedures requiring a TAT longer than 48 hours (excluding the above exceptions) shall be identified by the Contractor before contract award and approved by the Contracting Officer.

6.A.2.9 Reporting of Results 6.A.2.9.1 A report is defined as a printed final copy of laboratory testing results. This report shall be received by remote terminal where applicable. If results are previously telephoned, the report shall include the name of the individual notified of the results.

6.A.2.9.2 Each test report shall at minimum indicate the following information:

1. Patient’s name and/or identification code (Social Security Number)

2. Physician’s name (if specified)

3. Medical record number (if specified)

4. Facility Name

5. Date/time specimen received in Reference Lab

6. Test ordered

7. Date/time of specimen collection (when available)

8. Date test completed

9. Test result

10. Testing laboratory specimen number

11. Name of testing laboratory and address (contractor and/or subcontractor)

12. Type of specimen

13. Any additional comments related to test provided by submitting lab

14. Any other information the laboratory has that indicate a questionable validity of test results

15. Unsatisfactory specimen shall be reported regarding its unsuitability for testing.

6.A.2.10 Specimen Retention: Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering facility COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA.

6.A.2.11 Documentation 6.A.2.11.1 The Contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the contractor personnel’s own signature to the documents and validating their contents.

6.A.2.11.2 Monthly Bill Summary: The Contractor shall provide a monthly billing statement with the total dollar amount due including a date of issue and a due date to the Molecular Section in addition to prompt payment clauses within this contract. The account representative or consultant shall be available telephonically, or in person by appointment, as needed, to help troubleshoot, service the account, and introduce new tests, etc.

6.A.3: Service and Maintenance 6.A.3.1 The Contractor shall provide telephone number(s) and contact person to be used by the ordering facility to make specimen problem inquiries and problem solving at all times including weekends and holidays. The Contractor shall include names and telephone numbers of the technical directors and pathologists available for consultation.

6.A.3.2 The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification shall be given to the ordering facility upon adverse action by a regulatory agency. The Contractor shall advise the ordering facility with a two (2) week advanced notice of any changes in methodology, procedure, reference ranges and any new tests introduced.

6.A.3.3 In the event that the contractor changes the assay procedure or a critically important component of an assay, the Contractor shall notify the Lab prior to the intended change. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO.

6.A.4: Contract Quality Assurance/Quality Control 6.A.4.1 The Contractor Facility methodologies (defined as the principal of the method and the references) and quality control procedures may be examined by representatives of the government at any time during the life of the contract.

6.A.4.2 The Contractor shall comply with all applicable OSHA, Federal and State laws and regulations as required for performing the type of services required.

6.A.5: Delivery:

6.A.5.1 The Contractor shall ensure the accurate and timely performance of laboratory testing services of biologic specimens. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and medical laboratory professions. Such standards and operating manuals shall include the procedures as outlined in the CAP Inspection Checklists (current edition) which are hereby incorporated by reference with the same force and effect as if set forth in full text.

6.A.5.2 Sample Preparation: The ordering facility will prepare and package laboratory specimens in accordance with the requirements defined in the Contractor’s laboratory user’s manual. The Contractor shall provide, at no charge, an adequate supply of requisition forms, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user manual. The Contractor shall supply any special preservatives required for specimen preservation.

6.A.5.3 Security: It is currently planned that no requirement exists for LIS interface, however, change could occur, and these requirements are furnished accordingly.

6.A.5.3.1 Any security requirements of the Contracting personnel will be specified by the ordering facilities Information Security Officer (ISO). The requirements may apply to personnel, contractor property and/or information technology.

6.A.5.3.2 The Contractor shall abide by the “VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim – Oct 2008).”

6.A.5.3.3 The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel regarding information and information system security. These include Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s website at: http://checklists.nist.gov 6.A.5.3.4 To ensure that appropriate security controls are in place, contractors shall follow the procedures set forth in “VA Information and Information Security/Privacy Requirements for IT Contracts” located at the following website: http://www.iprm.oit.va.gov. These provisions shall apply to all contracts in which VA sensitive information is stored, generated, transmitted, or exchanged by VA, a contractor, subcontractor or a third-party, or on behalf of any of these entities regardless of format or whether it resides on a VA system or contractor/subcontractor’s electronic information system(s) operating for on the VA’s behalf. Clauses (a) and (b) shall apply to current and future contracts and acquisition vehicles including, job orders, task orders, letter contracts, purchase orders, and modifications. Contracts do not include grants and cooperative agreements covered by 31 U.S.C. §6301et seq.

These are found in VHA Directive 6210. Basically, computer system processing is sensitive, but unclassified information, and shall have the appropriate security features. The following security requirements are in addition to the VHA Directive 6210 policy of initial and periodic security training and the need for physical controls to protect hardware.

6.A.5.3.5 This computer system will be processing and transferring data that is classified as Sensitive but Unclassified (SBU) and shall have the appropriate security features. Electronic transmission of identifiable patient information shall be in compliance with requirements of the Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the VAs basic policy of initial and periodic security training, and the need for physical controls to protect hardware. For example:

· Discretionary Access Control; (access control lists).

· Object Reuse; (hard drives/diskettes will be wiped clean of information before turned in to Acquisition/Logistics for transfer back to the Contractor).

· Identification and Authentication (user ID and passwords to use the system).

· Audit (the system shall have audit trail capability).

· Operational Assurance (protection from external interference or tampering).

· Accreditation (signed by a designated accreditation authority).

6.A.5.4 Delivery – The adherence to established timeliness standards and accurate reporting of specimen test results is essential. With this agreement, results will be sent via fax from the reference laboratory to the RLR VAMC laboratory. The selected reference laboratory shall provide exceptional service and prompt responsiveness to the RLR VAMC laboratory staff and the physicians treating patients at the RLR VAMC and associated VA facilities. The contractor shall also provide preliminary test results (progress reporting) for those tests requiring it.

6.A.5.5 Government Furnished Equip – None.

6.A.6. Place of Performance – A.6.1 All specimens will originate from the RLR VAMC. The results from the specified testing will then be accurately and timely redelivered to the RLR VAMC. The selected reference laboratory will be responsible for the adherence to the STAT/non-STAT timing requirements given above. Actual testing locations are non-factors so long as accuracy and time requirements are met.

6.A.6.2 The ordering facility reserves the right to determine the tests sent to the Contractor and to add tests not previously sent. The contracting facility shall follow the specimen retention guidelines stated in the contract.

36C25020Q0070 6.A.6.3 Tests shall be performed and tested entirely upon the premises of the Contractor, or within the Contractor’s network of laboratories, or subcontracted to a fully qualified laboratory in accordance with the terms of this contract. Contractor referrals to a secondary (subcontractor) laboratory will be kept to a minimum for control and uniformity purposes. Once a particular test is designated (at contract award) for performance by a particular subcontractor, then all future test performance of that test method shall be done by the same subcontractor unless concurrence to change is received, in writing, from the Government.

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of Award through Last Option Period Exercised.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 50.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of 5,000.00;

(2) Any order for a combination of items in excess of $10,000.00; or

(3) A series of orders from the same ordering office within 10 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor…