36C26318Q0590-001.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 63

437-19-1-029-0002

36C26318Q0590 05-25-2018

Scott Hendrix 651-239-3024 06-27-2018 1:00pm CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

ATTN: Scott Hendrix 316 Robert Street N.

St. Paul MN 55101

X 100

X

621511

$32.5 Million

X

N/A

X

Department of Veterans Affairs Fargo VA Health Care System 2101 Elm Street N.

Fargo ND 58102

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

ATTN: Scott Hendrix 316 Robert Street N.

St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Provide Local Reference Laboratory Testing services for the Fargo VA Health Care System.

See Schedule of Services Section B.3.

See Statement of Work Section B.4.

See Proposal Submittal Instructions Section E.2.

See CONTINUATION Page

X 1

Scott E. Hendrix Contracting Officer

Veteran-OwnedX

36C26318Q0590

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

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

2011)

B.3 SCHEDULE OF SERVICES

B.4 STATEMENT OF WORK

B.5 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN

2017)

C.2 52.216-18 ORDERING (OCT 1995)

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

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 33

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

C.9 VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS

SET-ASIDE (JUL 2016)(DEVIATION)

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

2012)

C.11 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

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

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017)

E.2 PROPOSAL SUBMITTAL INSTRUCTIONS

E.3 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY

REFERENCE (JAN 2008)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (NOV 2017)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

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

SYSTEM FOR AWARD MANAGEMENT (SAM) REGISTRATION IS REQUIRED TO BE

ACCOMPLISHED BY THE CONTRACTOR BEFORE CONTRACT AWARD.

https://www.sam.gov/portal/public/SAM (SEE FAR PART 12)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See provision 52.212-1 “Instructions to Offerors – Commercial Items). All offers are subject to all terms and conditions of this solicitation.

1. CONTRACT ADMINISTRATION DATA

a. CONTRACT ADMINISTRATION: List below responsible party that may be contacted during the term of this contract for matters pertaining to the contract:

Contractor Name: __________________________________________

Title: __________________________________________

Address: __________________________________________

Telephone: __________________________________________

Facsimile: __________________________________________

E-mail: __________________________________________

Federal Taxpayer Identification ___________________________________________ Number Dun and Bradstreet Number ___________________________________________

b. Government: Contracting Officer - Scott E. Hendrix Network Contracting Office 23 316 Robert Street N., Suite 506 St. Paul, MN 55101 Phone (651) 293-3024 Scott.hendrix@va.gov

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 https://www.sam.gov/portal/public/SAM mailto:Scott.hendrix@va.gov

[ ] 52.232-36, Payment by Third Party

3. BILLING FOR SERVICES:

3.1 Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted within 30 days of the end of each month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

1. Name and Address of Contractor

2. Contractor’s ID Number (Tax ID number)

3. Invoice Date and Invoice Number

4. Contract Number and Purchase/Task Order Number

5. Date of Service

6. Line Item Pricing

7. Total Price

3.2 Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically per the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The contractor shall submit electronic payment requests through:

3.2.1 VA’s Electronic Invoice Presentment and Payment System (See Web site at http://www.fsc.va.gov/einvoice.asp); or,

3.2.2 A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.

3.2.3 The Contractor may contact Tungsten or FSC at the phone number or email address listed below with any questions about the e-invoicing program:

3.2.3.1 Tungsten e-Invoice Setup Information: 1-877-489-6135

3.2.3.2 Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3.2.3.3 FSC e-Invoice Contact Information: 1-877-353-9791

3.2.3.4 FSC e-invoice email: vafsccshd@va.gov

3.2.4 All payments shall be processed in accordance with the payments clause (FAR

Clause 52.232-1).

3.3 Payment:

3.3.1 Payment Adjustments: The Contractor will be paid only for actual work performed on-site at the Omaha VA.

3.4 The COR will review the invoice to ensure accurate invoicing.

http://www.fsc.va.gov/einvoice.asp http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com http://vafsccshd@va.gov

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

AMENDMENT NUMBER DATE

5. SAFETY REQUIREMENTS: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee may determine to be reasonably necessary to protect the lives and health of the occupants of the buildings. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the forgoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his/her representative at the site of the work, shall be deemed sufficient for the purposes aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

6. CONFORMITY TO REGULATIONS: The Contractor and his/her operators shall conform to all regulations, Federal, State, and local, governing the performance of contracted services.

7. TYPE OF CONTRACT: Resultant contract shall be a single award Indefinite Delivery / Indefinite Quantity (IDIQ) contract effective for the period stated in the Schedule of Services.

8 TERM OF CONTRACT: Resultant contract shall be effective for a period of one year from 10/01/2018 (or date of award) through 09/30/2019 with four (4) one-year option periods.

9. POINT OF CONTACT: The Contractor shall provide a point of contact (POC) who shall be responsible for the performance of the work under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily operation of this contract. The POC may be a contract health care provider performing under this contract. An alternate may be designated, but the Contractor shall identify, in writing, those times when the alternate shall act as the POC. The Contractor shall identify the POC and alternate in writing to the Contracting Officer’s Representative (COR) and Contracting Officer (CO). The Contractor shall give written notification to the COR and CO of the time when the alternate will act as the POC. The POC shall be available by telephone Monday through Friday, 8:00 AM through 4:30 PM, excluding Federal holidays.

10. SECURE FAX: VA Handbook 6500 requires the following statement on all fax cover sheets be included: “This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribute on, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

11. CITIZENSHIP RELATED REQUIREMENTS:

The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document (see Attachment 3 – Immigration and Nationality Act Certification).

12. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT:

In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contract providers (s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service.

http://oig.hhs.gov/exclusions/index.asp

CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

13. POST AWARD ORIENTATION: The Contracting Officer will schedule a post-award orientation conference for contract orientation purposes as required by IL 003A3-12-04.

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND

COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.219-11 VA Notice of Total Veteran-Owned Small Business Set- Aside. 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.

B.3 SCHEDULE OF SERVICES

The contractor agrees to furnish all personnel, supplies, facility and equipment to provide services necessary to perform Local Reference Laboratory testing services for the Department of Veterans Affairs, Fargo VA Health Care System (FVAHCS) (hereinafter referred to as “FVAHCS”), 2101 Elm Street N., Fargo, ND 58102. Reference Laboratory Services include, but are not limited to: specimen preparation and storage; transportation of clinical laboratory specimens, microbiology cultures, and stocks;

performance of analytical testing; reporting of analytical test results; and consultative services.

Offeror is instructed to provide pricing on Attachment 1 – CPT Code Listing – Local Reference Lab

Contract minimum: $10,000.00 Contract Maximum: $150,000.00

Place of Performance: Services shall be provided at contractor’s site. In addition, contractor will provide courier service between contractor’s facility and the FVAHCS.

Contractor is responsible for providing the applicable CPT code and the VA reserves the right to review them at any time.

Only those tests listed on Attachment 1 – CPT Code Listing – Local Reference Lab shall be performed and invoiced under this contract.

A Task Order will be issued at the beginning of each period of performance for that specific period of performance. Each Task Order shall state the period of performance for which it is applicable.

“Attachment 1 – CPT Code Listing – Local Reference Lab” identifies the CPT codes (all inclusive— unless otherwise noted), representing estimated quantities and do not reflect the actual quantities that may be required. The estimated quantities may decrease or increase based on the volume of work. The contract shall be for the actual requirements of the VA as ordered by the VA during the life of the contract.

Base Period 10/01/2018 – 09/30/2019

CLIN

No.

SUB-

Description Estimated

Qty. Unit Unit Cost Total Estimated Cost

0001 None

CPT Code rates (all inclusive) and quantities as described in Attachment 1 – CPT Code Listing – Local Reference Lab.

1 Lot DO NOT

PRICE $_______________

Option Period One 10/01/2019 – 09/30/2020

Option Period Two 10/01/2020 – 09/30/2021

Option Period Three 10/01/2021 – 09/30/2022

Option Period Four 10/01/2022 – 09/30/2023

Base and All Option Periods Total Estimated Cost:_________________________

No.

Estimated Cost

1001 None

CPT Code rates (all inclusive) and quantities as described in Attachment 1 – CPT Code Listing – Local Reference Lab.

1 Lot DO NOT

PRICE $_______________

CLIN

No.

Estimated Cost

2001 None

CPT Code rates (all inclusive) and quantities as described in Attachment 1 – CPT Code Listing – Local Reference Lab.

1 Lot DO NOT

PRICE $_______________

CLIN

No.

Estimated Cost

3001 None

CPT Code rates (all inclusive) and quantities as described in Attachment 1 – CPT Code Listing – Local Reference Lab.

1 Lot DO NOT

PRICE $_______________

CLIN

No.

Estimated Cost

4001 None

CPT Code rates (all inclusive) and quantities as described in Attachment 1 – CPT Code Listing – Local Reference Lab.

1 Lot DO NOT

PRICE $_______________

B.4 STATEMENT OF WORK

REFERENCE LABORATORY

1. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Services to the Fargo VA Health Care System. Reference Laboratory Services include, but are not limited to: specimen preparation and storage; transportation of clinical laboratory specimens, microbiology cultures, and stocks;

performance of analytical testing; reporting of analytical test results; and consultative services.

2. Specimen Preparation and Storage for Reference Testing Specimens

2.1. Contractor shall supply each Government facility with its commercial laboratory reference test manual to insure that the collection and storage of specimens are in accordance with Contractor’s requirements.

2.2. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen.

3. Transportation Services for Reference Testing Specimens

3.1. Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

3.2. Routine transportation services shall occur at a minimum of once per day excluding weekends and Government Holidays from the Fargo VA Health Care System. Specimen pick-up times will be negotiated after contract award.

3.3. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

3.3.1. Test request forms

3.3.2. Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.).

4. Transportation beyond routine pick-up: services shall be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 1 hour. This response time refers only to the transportation of the specimen(s) and does not include the time for test performance.

5. Specimen Testing

5.1. The Contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment 1 – CPT Code Listing – Local Reference Lab. Contractor shall make available the following test information:

5.1.1. Requisition form requirements

5.1.2. Alphabetized test name list

5.1.3. Test order code

5.1.4. Specimen collection and preservation requirements

5.1.5. Test method employed (indicate if testing performed in duplicate) and interpretations

5.1.6. Test reference intervals adjusted for age, sex or race, when required

5.1.7. Test specific sensitivity, specificity and interferences, when required

5.1.8. Test critical values, if any

5.1.9. CPT coding

5.1.10. Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a Government facility.

5.1.11. Schedule of test performance (specific days of week indicated)

5.1.12. Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited)

5.2. Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

5.3. Any new test(s) not listed in Attachment 1 – CPT Code Listing – Local Reference Lab must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested.

5.4. All reference laboratory testing shall be executed in accordance with standard industry practices.

It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

5.5. The Contractor shall ensure the accurate and timely performance (defined in Section 5.1.10) of laboratory testing services on the biomedical materials.

6. Specimen Retention

6.1. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication.

6.2. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported.

7. Reporting of Results

7.1. The results of testing shall be reported within the prescribed turnaround times provided by the

Contractor as part of the test information (defined in Section 5.1.10).

7.2. A report of laboratory testing results must be issued either as a printed final copy or through the host to host electronic transmission of the test results. The results can be faxed to the Fargo VA secure fax phone number 701-237-2646.

7.3. Each test report shall, at minimum, include the following information:

7.3.1. Patient's full name

7.3.2. Patient’s identification number, e.g. social security number (SSN)

7.3.3. Physician’s name (if supplied)

7.3.4. Submitting facility name

7.3.5. Test(s) ordered

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

7.3.7. Date/time test completed

7.3.8. Test result

7.3.9. Reference intervals (adjusted for age, sex or race, when appropriate)

7.3.10. Toxic and therapeutic ranges, if applicable

7.3.11. Flagged abnormal results

7.3.12. Name and address of testing laboratory

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

7.3.14. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

7.4. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

8. Customer Service

8.1. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

8.2. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

8.2.1.1. Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

8.2.1.1.1. Specimen Collection

8.2.1.1.1.1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

8.2.1.1.2. Testing

8.2.1.1.2.1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

8.2.1.1.3. Technical Expertise

8.2.1.1.3.1. Result interpretation inquiries shall be addressed within four business hours of initial call.

8.3. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

9. Consultative Services/Utilization Reports

9.1. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

9.1.1. A copy of the report shall be delivered electronically to the Contracting Officer, Lead COR, and each Government facility COR by the 10th of the month following the close of the reporting month.

10. SPECIAL CONTRACT REQUIREMENTS

10.1. Services

10.1.1. The services specified herein may be changed by written modification to this contract.

The VA Contracting Officer will prepare the modification (reference FAR clause 52.212- 4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

10.1.2. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government.

The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

10.1.3. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

10.1.4. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

10.1.5. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

10.1.6. Contractor shall not, under any circumstances, furnish reports directly to patients.

10.2. Federal Holidays

10.2.1. Contractor is not required to provide routine daily transportation of specimens on federal holidays. The 10 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans

Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

10.2.2. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

10.3. Qualifications/Requirements of Laboratory & Contractor Personnel

10.3.1. Laboratory

10.3.1.1. Offeror must have at least three years of experience in providing laboratory testing services and must have at least one year experience in transporting biomedical materials.

10.3.1.2. Offerors, including subcontractor(s), must continuously hold a Certificate of

Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract.

10.3.1.3. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the Contracting Officer’s Representative assigned to each Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

10.3.1.4. Contractor must notify immediately the Contracting Officer’s Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure.

10.3.1.5. Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

10.4. Personnel

10.4.1. Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations’ and State standards.

10.4.2. Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification.

10.4.3. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

10.4.4. Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor‘s company. In addition, the Contractor representative shall prominently display a contractor-issued identification badge.

10.5. Record Keeping – Contractor

10.5.1. Contractor must establish a record keeping system of all tests performed.

10.6. Medical Records

10.6.1. Clinical or other medical records (ie. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA. If requested, test results will be mailed to the VA at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm.

If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received.

10.7. Confidentiality of Patient Records

10.7.1. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received.

The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

10.7.2. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

10.8. HIPAA Compliance

http://www1.va.gov/vhapublications/index.cfm

10.8.1. Contractor must adhere to the 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 and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

10.9. Designation of Contract Representatives

10.9.1. The Laboratory Manager – VISN 23 Pathology & Laboratory Medicine Services (P&LMS), Fargo, ND, will be designated as the Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo.

10.10. Contract Performance Monitoring

10.10.1. Contractor's employee(s) shall report to the front desk, upon arrival at the VA for specimen pickup.

10.10.2. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance.

Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

10.10.2.1. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

10.10.2.2. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Schedule of Services / Attachment 1 – CPT Code Listing – Local Reference Lab. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

10.10.2.3. Departments being served, through the COR(s), will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

10.11. Quality Assurance Monitoring

10.11.1. Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract.

10.11.2. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled.

The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the facility/VISN 23 staff for process review and improvement of contract performance on an as needed basis.

10.11.3. Copies of licensure/certifications are also required to be submitted upon request by the

VA.

10.11.4. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc. and can be found in Attachment 2 – QASP – Local Reference lab.

11. CONTRACT SECURITY REQUIREMENTS

11.1. General

12. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

12.1. Contractor Personnel Security Requirements

13. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

14. Contractor shall certify that all its employees and subcontractor employees having access to VA sensitive information (ie. laboratory technicians, administrative personnel) during the performance of this contract have successfully passed a contractor employee background check.

14.1.1.1. Position Sensitivity - The position sensitivity has been designated as Low Risk.

14.1.1.2. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.

14.1.2. Contractor Responsibilities

14.1.2.1.1. The contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

B.5 IT CONTRACT SECURITY

VA HANDBOOK 6500.6 VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1568 , http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=832&FType=2 . The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S.

may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1568 http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=832&FType=2 allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=429&FType=2 and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=475&FType=2 and VA Handbook 6500.1, Electronic Media Sanitization http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=416&FType=2 .

Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies.