S02 - 36C26321R0002.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. 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 76

36C26321R0002 12-07-2020

Daniel Vagts 651-239-3040 12-28-2020

11:59AM EST

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

X

621511

$35 Million

N/A

N/A

Department of Veterans Affairs

Minneapolis VA Medical Center

One Veterans Drive, Building 70

Minneapolis MN 55417

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Steven Porwoll

316 ROBERT ST N. STE 506

SAINT PAUL MN 55101

Y

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Pathology and Laboratory Medicine Services for the

Department of Veterans Affairs (VISN)

See Schedule of Items - Section B.2, page 6.

See Statement of Work - Section B.3, page 7.

See CONTINUATION Page

X ONE

Daniel Vagts

Contract Officer

36C26321R0002

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF ITEMS - PRICING – See Section D: D.5 – Attachment 5 – Schedule of Items –

Price List Excel Spreadsheet

B.3 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

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

C.2 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN

2016)

C.4 52.216-18 ORDERING (AUG 2020)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.8 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.9 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.10 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.11 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.14 VAAR 852.219-9 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM REQUIREMENTS

(DEC 2009)

C.15 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL

BUSINESS SET-ASIDE (JUL 2019) (DEVIATION)

C.16 VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE

(JUL 2019) (DEVIATION)

C.17 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.18 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE

(JUL 2018)

C.19 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

C.20 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.21 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 2008)

C.22 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)

C.23 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (AUG 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 List of Attachments

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008)

E.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL

BUSINESS EVALUATION FACTORS (OCT 2019)

E.8 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)

E.9 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO BENEFICIARIES (JAN

2008)

E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (AUG

2020)

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 36C263

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] MONTHLY

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

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 SCHEDULE OF ITEMS - PRICING – See Section D: D.5 – Attachment 5 – Schedule of Items – Price

List Excel Spreadsheet

Period of Performance:

Base Period: 01-01-2021 – 12-31-2021 - $

Option Period One: 01-01-2022 – -12-31-2022 - $

Option Period Two: 01-01-2023 – 12-31-2023 - $

Option Period Three: 01-01-2024 – 12-31-2024 - $

Option Period Four: 01-01-2025 – 12-31-2025 - $

Grand total for Base and all Option Periods. $

In accordance with FAR 16.504(a)(1), The guaranteed minimum and maximum dollar amounts are listed in the table below. These amounts cover the base contract. The maximum dollar amounts listed shall not be exceeded.

IDIQ Established MIN and Max dollar amounts for Base Period and all Option Periods:

Minimum $2,000.00

Maximum $3,499,000.00

Ordering Procedures

Each ordering vehicle will document the quantity, and other pertinent data to ensure the services provide the appropriate level of patient care to the maximum order allowable under the resultant contract. No additional services are authorized without prior approval through the Administrative Contracting Officer and/or Contracting Officer.

B.3 STATEMENT OF WORK

1. SCOPE OF WORK

The US Department of Veterans Affairs Health Care System (hereinafter referred to as VISN 23) intends to issue a contract for “Complex Case Consultation and Testing for Anatomic Pathology, Neurology, and

Infectious Disease” services for the VISN 23 Pathology and Laboratory Medicine Service (PLMS). All services provided shall be in accordance with the prices, terms and conditions of this contract.

Participating facilities include:

• VA Black Hills Health Care System, Hot Springs, SD

• VA Black Hills Health Care System, Ft. Meade, SD

• Fargo VA Health Care System, Fargo, ND

• VA Nebraska-Western Iowa Health Care System, Omaha, NE

• VA Nebraska-Western Iowa Health Care System, Lincoln, NE

• VA Nebraska-Western Iowa Health Care System, Grand Island, NE

• St. Cloud VA Healthcare System, St. Cloud, MN

• Sioux Falls VA Health Care System, Sioux Falls, SD

• VA Central Iowa Healthcare System, Des Moines, IA

• Minneapolis VA Healthcare System, Minneapolis, MN

• Iowa City VA Healthcare System, Iowa City, IA

Please refer to Attachment A for list of required testing.

2. CONTRACT TYPE AND TERM

The VA will award a firm, fixed-price, indefinite delivery-indefinite quantity commercial services contract for all items listed in the Schedule of Items.

Effective period of the contract base year shall be from date of award through twelve (12) months with the options to extend the contract for additional 12-month periods, at the discretion of the VA, for up to four (4) additional years. Total contract will not exceed five years. Contractor shall be notified by written notice, within 60 days of contract anniversary date, of the VA’s intent to renew.

3. STATEMENT OF WORK

VISN 23 Pathology & Laboratory Medicine Service requires services of a contractor to provide specialized specific complex case diagnostic testing and consult services.

Testing needs may consist of, but are not limited to, serological and in situ hybridization-based tests for infectious disease; quantitative tissue analysis for copper and iron; specialized neurological testing;

screening for hereditary disorders such as hereditary non-polyposis colon carcinoma syndrome;

hemoglobin electrophoresis; molecular testing for mutations for hematopoietic neoplasms; and consultation on complex anatomic pathology cases, including ophthalmologic, pulmonary and urologic pathology.

These services require a comprehensive academic medical center with extensive expertise across a wide range of surgical pathology disciplines and organ systems. The pathology department must include nationally recognized experts in a variety of areas of anatomic pathology, such as urologic, gastrointestinal, pulmonary, and soft tissue/ orthopedic pathology. In addition, the medical center must include a division or subdivision of ophthalmologic pathology, with specialized ophthalmologic pathologists.

The contractor must be able to offer specialized testing for infectious disease, including in situ hybridization for histoplasma in tissue, and urinary histoplasma antigen.

The contractor must be able to provide specialized testing included in Attachment A.

Contractor shall provide laboratory testing services to include: List of tests with reference ranges, specimen requirements, processing and analysis of the specimen; and reporting of specimen results.

Consultation regarding test selection, collection, transportation and result interpretation shall also be provided when required. The contractor must provide the following services:

Provide the following for transport of the specimens to include:

• Lab test request forms (it is possible that vendor may need to customize forms to include information required by the VA).

• Special instructions for handling of specimen.

• Specimen collection supplies for specialized testing.

• Provide the courier service for transport of specimens, where available.

• Provide shipping supplies, including boxes.

Analyze samples.

Contractor shall provide a monthly billing for tests provided each month following the month in which the service was delivered.

Contractor shall consult with VA Laboratory on test results by telephone as needed.

Provide the VA Laboratory with a means of communication to permit immediate inquiry regarding the status of a pending test.

A Laboratory User’s Manual or similar documentation will be provided to the VA Laboratory.

The manual shall include a list of all tests that the Contractor can provide along with the testing methodology used for each test, test reference ranges, length of time of testing, which days the test is run, and specimen requirements and any special handling required.

Licensing and Accreditation

The Contractor’s shall assure compliance of all procedures and practices by the following accrediting agencies, and the facility and employees shall have all licenses, permits, accreditation, professional certifications and qualifications required by federal and state law to provide laboratory testing and consult services. This includes:

Accreditation by the College of American Pathologists (CAP)

Accreditation by the Centers for Prevention and Disease Control (CDC)

Contractor Qualification Requirements

The pathologists for interpretive reports must have an unrestricted license to practice medicine in one of the states or territories of the United States of District of Columbia.

A division or subdivision of ophthalmologic pathology must exist within the medical center, with

Ophthalmologic Pathologists on staff who have fellowship experience or other specialized training in eye pathology.

Expert consultant pathologists must have national reputations in their areas of specialization, as evidenced by ongoing publication in academic journals and/or presentations at national pathology meetings. Special attention will be paid to expertise in male genitourinary, soft tissue/bone, gastrointestinal, and pulmonary pathology. Sponsorship of subspecialty fellowships in adult surgical pathology, such as gastrointestinal, pulmonary, genitourinary, or bone and soft tissue fellowships, is also desirable.

Consultations must be performed by pathologists that have specific expert and appropriate training in the area of consult. The VA Medical Center Laboratory Director reserves the right to ask for a specific pathologist to review specific cases that are considered to be abnormal or difficult.

Test Sample Preparation

The VA laboratory shall be responsible to provide laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing.

The contractor shall provide 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’s manual.

Transport of Specimens

Minneapolis VA Laboratory will require a courier to pick up samples once per day, Monday through

Friday, excluding holidays. All other Medical Center Laboratories should have availability of an on-call courier, where possible.

Turn Around Time

Contractor shall provide a faxed report on anatomic pathology consultation cases within 4 working days of receipt of specimen, unless additional testing such as immunohistochemistry or molecular gene rearrangement studies is required.

Urinary histoplasma antigen shall be reported within 8 working days. Specialized neurological testing shall be reported within 14-17 working days.

Reporting of Test Results

A report is defined as a printed final copy of pathology interpretive consult. Consult reports shall be sent by contractor to secure VAMC Laboratory in the VAMC Pathology & Laboratory Medicine Service office. If results are telephoned prior to sending, the written report must include the name of the individual notified of the results, date and time of telephone report. Each consult report shall at a minimum indicate the following information:

Patient’s name and identification code

Physician’s name (if supplied)

VA Medical Center name

Patient’s location, e.g. clinic, ward (if supplied)

Test ordered

Date/time of specimen collection (when available)

Date/time specimen received in Reference Lab

Date test completed

Test result

Flag abnormal results

Reference Range

Toxic and/or therapeutic range where applicable

Name of testing laboratory (contractor and/or subcontractor)

Testing laboratory specimen number

Type of specimen

Comments related to the test provided by the submitting lab

Information that may indicate a questionable validity of test results

Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract:

• For quality purposes, tests routinely performed in duplicate should be indicated.

• Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

• Proficiency testing data shall include a list of tests outside of the ± 2 SD range for the past two years. Contractor shall notify the laboratory of any test falling outside ± 2 SD range during the contract period.

• Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.

• The contractor(s) facilities, methodologies (defined as the principal of the method and references), and quality control procedures may be examined by representatives of the VA at any time during the life of the contract.

• Contractor agrees to maintain the minimum acceptable service, reporting systems and quality controls as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

Testing Summaries

Contractor shall provide each laboratory with a testing summary report each month following the month in which the testing service was provided. At the end of each contract year a cumulative (year-to-date) report shall be submitted to the VA providing the name of test ordered, price of test, cumulative totals and a total of all funds spent by that VA facility on laboratory testing services.

Testing Changes

The Contractor shall advise the VA of any changes in assay methodology, procedures, reference ranges and any new tests introduced.

In the event that the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the VA Contracting Office and the VA Laboratory Director prior to the intended change. He shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved.

Changes in the assay material, testing procedures or methodology that have not been reviewed and pre-approved by VA Laboratory Director and mutually agreed upon in writing between the contractor and the VA Contracting Officer, may be sufficient cause for the VA to use an alternate contractor for that specific test for the duration of the contract.

There will be times where the change in methodology needs to occur before notifying VMAHCS, in these cases, VMAHCS is to be notified as soon as the vendor is able to.

Contractor Telephone Numbers

Contractor shall provide telephone number(s) and contact person(s) to be used by the VA Pathology &

Laboratory Medicine Service for specimen inquiries, and Lab Technical/Pathologist consultation. There must be someone available at the number(s) provided at all times including weekends and holidays.

Phone Number Specimen Inquiries: __________________________

Lab Technical Director/Pathologists: __________________________

4. SUBCONTRACTING APPROVAL

If Contractor intends to use a subcontractor to provide any of the testing required under this contract, Contractor shall be responsible for finding a subcontractor laboratory with appropriate licensure and accreditation. Contractor shall notify the VA Contracting Office of any plan to use a subcontractor or make a subcontractor change, and request a prior acceptance and approval from VA.

Contractor will use the following subcontractor(s):

5. CHANGES

Changes in the terms and conditions of this contract may be made only by written agreement of both parties. Contractor must submit requests for changes in writing to the VA Contracting Office. Any and all modifications to this contract must be approved and prepared by the VA Contracting Officer for signature.

6. QUALITY ASSURANCE

The government will evaluate the Contractor’s performance under this contract and the Contractor performance will be monitored to determine if it meets the contract standards. A variety of methods may be used. Nonperformance or substandard task performance will be documented if and when it occurs. The Technical Representative will follow the methods of surveillance specified in the

Performance Measures.

Performance Measures

The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the Technical Representative and reported to the Contracting Officer.

Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions.

Performance will be monitored using the following criteria:

Government Roles and Responsibilities:

The Midwest Healthcare Network Contracting Officer shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Jill Johnson, VISN 23 Health

System Specialist, has been designated as the representative to coordinate these services.

Technical Representative:

Jill Johnson, COR

(605) 310-0671

Jill.johnson2@va.gov

PERFORMANCE

OBJECTIVE

TASK

PERFORMANCE

STANDARD –

IAW PWS 5.8

and 5.9

ACCEPTABLE

(MINIMAL)

QUALITY

LEVEL (AQL) 1

MONITORING

METHOD

INCENTIVE DISINCENTIVE2

Ensure the safety and integrity of specimens

No loss or destruction of specimens

1 per Month per

Facility

Contractor

Reporting

Favorable Contractor

Performance

Evaluation

Unfavorable contactor performance evaluation

Testing services will be performed in accordance with the defined turnaround times

(TAT)

Results will be reported within the TAT listed in the contractor’s laboratory reference test manual per test

90% of the time per Facility

Contractor

Reporting

Favorable Contractor

Performance

Evaluation

Unfavorable contactor performance evaluation

Revised Reports Not due to incorrect requisition information

1 Per Month per

Facility

Contractor

Reporting

Favorable Contractor

Performance

Evaluation

Unfavorable contactor performance evaluation

7. ORDERING PROCEDURES

This contract does not obligate any funding; therefore, the Contractor shall provide services under this contract only as directed in task orders. Task orders for bulk dollar amounts will be issued during the contract period. Any warranted VA Contracting Officer is authorized to issue task orders under this contract. Laboratory personnel may place verbal orders with the contractor to meet testing needs, up to the bulk task order total. The contractor will be required to inform the VA contract specialist or contracting officer when each task order reaches 80% of the total bulk dollar amount.

In accordance with FAR 16.505, each task order will include the following: (i) Date of order (ii) Contract number and order number (iii) Contract item number and description, quantity, and unit price or estimated cost or fee (iv) Delivery or performance date (v) Place of delivery or performance (including consignee) (vi) Packaging, packing, and shipping instructions, if any (vii) Accounting and appropriation data (viii) Method of payment and payment office, if not specified in the contract (ix) Any other pertinent information.

VA Electronic Invoice Presentment and Payment System: The VA Financial Services Center (FSC) uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge. Contact Tungsten/OB10 at the phone numbers or email listed below for assistance:

Tungsten/OB10 Support & setup Information: 1-877-489-6135

Tungsten/OB10 e-Invoice email: VA.Resgistration@tungsten-network.com

Tungsten/OB10 Client Services: 1-877-752-0900, option 1

Contractor must furnish a designated point of contact for placing orders. Orders for laboratory testing services shall be sent to Contractor through the contact person listed below at the following address:

(Offeror to complete)

Vendor’s Contact Person: ____________________

Telephone Number: _______________

FAX Number: ______________

Address: _____________________ http://ob10.com/us/en/veterans-affairs-us/ mailto:VA.Resgistration@tungsten-network.com

8. SAFETY AND SECURITY REQUIREMENTS

HIPAA Compliance and Requirements

Contractor will adhere to the applicable provisions of Public Law 104-191, Health Insurance

Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the

Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the

Department of Health and Human Services (HHS) has promulgated rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veterans

Affairs (VA). As defined in the Health Insurance Portability and Accountability Act (HIPAA) Public Law

104-191, your company may be required to execute a Business Associate Agreement.

If contractor’s facility is an entity that is not covered under the provisions of Public Law 104-191 HIPAA, then contractor will be required to execute a Business Associates Agreement.

Contractor certifies that his facility ( ) is ( ) is not an entity that is covered under applicable provisions of

Public Law 104-191 HIPAA.

9. INDEMNIFICATION AND MEDICAL LIABILITY

In accordance with FAR clause 52.237-7, the Contractor must have all necessary insurance coverage to operate a Pathology Laboratory. Contractor healthcare professionals and physicians providing services under this contract must be covered by medical liability insurance. Contractor must furnish the VA

Contracting Officer, prior to award of contract, with a certificate of insurance from his insurance company indicating that the coverage outlined in this document has been obtained. The certificate of insurance shall demonstrate the contract physicians and facility have medical malpractice insurance, general liability, and any other pertinent special insurance certificates. (See FAR clause 52.237-7

Indemnification and Medical Liability Insurance in section C of this document.) The insurance coverage may not be changed or canceled without a thirty (30) day written notice to the VA Contracting Officer.

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 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

(a) The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS

PUB) Number 201.

(b) The Contractor shall account for all forms of Government-provided identification issued to the

Contractor employees in connection with performance under this contract. The Contractor shall return such identification to the issuing agency at the earliest of any of the following, unless otherwise determined by the Government:

(1) When no longer needed for contract performance.

(2) Upon completion of the Contractor employee's employment.

(3) Upon contract completion or termination.

(c) The Contracting Officer may delay final payment under a contract if the Contractor fails to comply with these requirements.

(d) The Contractor shall insert the substance of this clause, including this paragraph (d), in all subcontracts when the subcontractor's employees are required to have routine physical access to a

Federally-controlled facility and/or routine access to a Federally-controlled information system. It shall be the responsibility of the prime Contractor to return such identification to the issuing agency in accordance with the terms set forth in paragraph (b) of this section, unless otherwise approved in writing by the Contracting Officer.

(End of Clause)

C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)

(a) Definitions. As used in this clause—

Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the

Government, but not including information provided by the Government to the public (such as on public

Web sites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures. (1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems.

Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information

(CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of Clause)

C.4 52.216-18 ORDERING (AUG 2020)

(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 the effective date of performance through the end of the effective period of performance.

(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) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.5 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 2,000.00, 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 $50,000.00;

(2) Any order for a combination of items in excess of $3,499,000.00; or

(3) A series of…