VA263-17-R-0448-002.docx

VA263-17-R-0448

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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

618-18-2-106-0041

VA263-17-R-0448

02-09 -2018 Daniel Vagts 651-293-3040 03-0 -2018

10:00AM CST

Department of Veterans Affairs NCO 23 - St Paul Attention: Daniel Vagts 316 Robert Street N.

St. Paul MN 55417 X 621511 $32.5 Million N/A X N/A X VA Medical Center Department of Veteran Affairs One Veterans Drive, Building 70 Minneapolis MN 55417 Department of Veterans Affairs NCO 23 - Minneapolis Attention: Daniel Vagts 316 Robert Street N.

St. Paul MN 55417

Y Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 X See CONTINUATION Page Pathology and Laboratory Medicine Services for the Minneapolis VA Medical Center.

See Schedule of Items (pg.6) See Performance Work Statement (pg.21) See CONTINUATION Page X X X

ONE

Daniel Vagts Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C618 Department of Veterans Affairs NCO 23 - St Paul Attention: Daniel Vagts 316 Robert Street N.

St. Paul MN 55417

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

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B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for Hub Zone Small Business Concerns. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

VA263-15-R-0860

(End of Clause)

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B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

B.4 SCHEDULE OF ITEMS

Contractor shall provide the following Pathology and Laboratory Medicine Services to the U.S. Department of Veterans Affairs Medical Center, Minneapolis MN. The offeror’s prices shall include all required labor, equipment, supplies, shipping/courier services and overhead costs as needed to meet the requirements listed in the Schedule of Items and Statement of Work. Prices as quoted shall be firm-fixed prices for the period specified.

BASE YEAR:

OPTION YEAR ONE:

SCHEDULE NOTES

Additional Tests It may occur that the VAMC laboratory will require a test not listed in the Schedule of Items but that is available from the contractor’s catalog of tests, or a new test becomes available that is not listed in the Schedule of Items. If a test is required that is not listed in the Schedule of Items, the VA and the contractor will negotiate a firm fixed price. The new tests will be added to the contract accordingly via a contract modification. These tests will be considered as part of the overall contract value and together with the other tests cannot exceed the total estimated contract value.

2. Estimated Quantities The quantities as listed in the “Schedule of Items” are estimated requirements for a twelve (12) month contract period with one (1) possible twelve (12) month options. The Government estimates, but does not guarantee, that the volume of purchases under this contract will be an estimated ceiling amount $985,000.00 for the entire 2-year contract period. The VAMC attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from the quantities listed. The Government is obligated only to the extent of the minimum contract guarantee. During the period specified in FAR clause 52.216-18, ORDERING, the Government shall place orders totaling a minimum of $50,000.00 for a 12-month contract period.

3. Multiple Award It would be most advantageous to the Government to award to a contractor who can provide all of the line items as requested in the Schedule of Items. The Government may establish a single contract award for ALL line items in lieu of multiple contracts or may establish multiple contracts, whichever provides the best value to the VAMC.

B.5 STATEMENT OF WORK

1. SCOPE OF WORK

The US Department of Veterans Affairs Health Care System, Minneapolis, MN, hereinafter referred to as MVAHCS or VA, intends to issue a contract for “Complex Case Consultation and Testing for Anatomic Pathology, Neurology, and Infectious Disease” services for the Pathology and Laboratory Medicine Service (P&LMS) located at MVAHCS, One Veterans Drive, Minneapolis, MN 55417. All services provided shall be in accordance with the prices, terms and conditions of this contract.

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; determination of erythrocyte, CSF, and serum enzyme levels; 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 laboratory must be able to provide specialized neurology testing to include the following assays:

Neuromyelitis optica (NMO) Autoantibody, IgG, Serum Antineuronal Nuc Aby, Type 1 Antineuronal Nuc Aby, Type 2 Antineuronal Nuc Aby, Type 3 Anti-Glial Nuc Aby, Type 1 Purkinje Cell Cyto Aby, Type 1 Purkinje Cell Aby, Type 2 Purkinje Cell Aby, Type TR Amphiphysin Aby, S CRMP-6-IgG Striational Muscle Aby P/Q Type Calcium Channel Aby N-Type Calcium Channel Aby Acetylcholine Receptor Binding Aby AChR Ganglionic Neuronal Aby, S Neuronal (V-G) K+ Channel Aby CRMP-5-IgG Western Blot The contractor must be able to offer specialized testing for infectious disease, including in situ hybridization for histoplasma in tissue, and urinary histoplasma antigen.

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.

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.

Provide the courier service for transport of specimens.

The MVAHCS Laboratory reserves the right to request the results of any proficiency testing that the contractor subscribes.

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.

The qualifications of such personnel shall also be subject to review by VA Medical Center Laboratory Director. VA reserves the right to approve the assignment of individual personnel furnished by the Contractor to perform the functions specified in the contract.

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 Vendor will work with the Minneapolis VA laboratory to arrange the transport of samples.

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 secured VAMC Laboratory FAX # 612-725-2079 located 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 Quality Control 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 the Minneapolis VA Laboratory 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.

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:

submitted

submitted

Government Roles and Responsibilities The MVAHCS Contracting Officer shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Amy Colbaugh, COR has been designated as the representative to coordinate these services. Her contact information is listed below.

Technical Representative:

Amy Colbaugh, COR Minneapolis VA Health Care System One Veterans Drive, P&LMS (113) Minneapolis, MN 55417

(612) 467-5989 amy.colbaugh@va.gov

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. The Minneapolis laboratory personnel may place verbal orders with the contractor to meet their 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: _____________________

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…