S02 - VISN 23 Lab Referral Service 36C26324R0072_05212024.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 104

36C26324R0072 05/21/2024

Shanna Comparato, Contract Specialist

402-995-3692 06/21/2024

10:00 CST

36C263

Department of Veterans Affairs Network 23 Contracting Office Attn: Michael Casper

316 Robert Street N. STE. 506 St. Paul, MN 55101

X

621511

$41.5 Million

X

N/A

X

36C618

Department of Veterans Affairs Minneapolis VA Medical Center One Veterans Drive, Building 70 h Minneapolis, MN 55417

36C263

Department of Veterans Affairs Network 23 Contracting Office

316 Robert Street N. STE. 506 St. Paul, MN 55101

Financial Services Center PO Box 149971 Austin, TX 78714-9971

See CONTINUATION Page

VISN 23 Midwest Health Care System, Laboratory Referral and Testing Services.

Period of Performance: 11/1/2024 – 10/31/2029 (5 Years)

See B.3 for Performance Work Statement, Pages 8 - 33

Participating Facilities:

VA Black Hills Health Care System, Hot Springs, SD VA Black Hills Heath Care System, Fort Meade, SD Sioux Falls VA Health Care System, Sioux Falls, SD Fargo VA Health Care System, Fargo, ND Minneapolis VA Health Care System, Minneapolis, MN St. Cloud VA Health Care System, St. Cloud, MN VA Central Iowa Health Care System, Des Moines, IA Iowa City VA Health Care System, Iowa City, IA 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

See CONTINUATION Page

Paid separately via individual issued Task Orders

X -One-

Michael Casper Contracting Officer

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCK 18A

B.1 Contract Administration Data

B.2 Schedule of Services

B.3 Performance Work Statement (PWS)

B.4 VA Information and Information System Security/Privacy Language

B.5 Records Management Obligations (NARA Language)

SECTION C – CONTRACT CLAUSES

C.1 FAR 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023) C.2 FAR 52.204-9 Personal Identity Verification of Contractor Personnel (January 2011) C.3 FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (November 2021) ... 47 C.4 FAR 52.216-18 Ordering (August 2020) C.5 FAR 52.216-19 Order Limitations (October 1995) C.6 FAR 52.216-22 Indefinite Quantity (October 1995) C.7 FAR 52.217-8 Option to Extend Services (November 1999) C.8 Addenda to 52.217-8 Evaluation of Option to Extend under FAR 52.217-8 C.9 FAR 52.228-5 Insurance Work on a Government Installation (January 1997) C.10 Supplemental Insurance Requirements C.11 FAR 52.232-19 Availability of Funds for the Next Fiscal Year (April 1984) C.12 VAAR 852.201-70 Contracting Officer’s Representative (December 2022) C.13 VAAR 852.203-70 Commercial Advertising (May 2018) C.14 VAAR 852.204-71 Information and Information Systems Security (February 2023) C.15 VAAR 852.211-76 Liquidated Damages – Reimbursement for Data Breach Costs (February 2023).. 58 C.16 VAAR 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (January 2023) C.17 VAAR 852.215-71 Evaluation Factor Commitments (October 2019) C.18 VAAR 852.219-70 VA Small Business Subcontracting Plan Minimum Requirements (November 2022) C.19 VAAR 852.219-73 VA Notice of Total Set-Aside for Verified Service-Disabled Veteran-Owned Small Business (November 2022) C.20 VAAR 852.219-75 VA Notice of Limitations on Subcontracting – Certificate of Compliance for Services and Construction (November 2022) C.21 VAAR 852.232-72 Electronic Submission of Payment Requests (November 2018) C.22 VAAR 852.237-72 Crime Control Act – Reporting of Child Abuse (October 2019) C.23 VAAR 852.237-74 Nondiscrimination in Service Delivery (October 2019) C.24 VAAR 852.242-71 Administrative Contracting Officer (October 2020) C.25 FAR 52.252-2 Clauses Incorporated by Reference (February 1998) C.26 FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders – Commercial Products and Commercial Services (February 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 FAR 52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (September 2023) E.2 Proposal Preparation Instructions (Addendum to FAR 52.212-1) E.3 FAR 52.212-2 Evaluation – Commercial Products and Commercial Services (November 2021) E.4 FAR 52.204-24 Representation Regarding Certain Telecommunication and Video Surveillance Equipment (November 2021) E.5 FAR 52.209-7 Information Regarding Responsibility Matters (October 2018) E.6 FAR 52.216-1 Type of Contract (Apr 1984) E.7 FAR 52.233-2 Service of Protest (September 2006) E.8 VAAR 852.209-70 Organizational Conflicts of Interest (October 2020) E.9 VAAR 852.233-70 Protest Content/ Alternative Dispute Resolution (September 2018) E.10VAAR 852.233-71 Alternate Protest Procedure (October 2018) E.11 VAAR 852.239-71 Information System Security Plan and Accreditation (February 2023) E.12 VAAR 852.239-75 Information and Communication Technology Accessibility Notice (February 2023) E.13 VAAR 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (January 2008) E.14 FAR 52.252-1 Solicitation Provisions Incorporated by Reference (February 1998) E.15 FAR 52.212-3 Offeror Representations and Certifications – Commercial Products and Commercial Services (November 2023)

VISN 23 Midwest Health Care System, Lab Referral Testing Services 36C26324R0072

SECTION B - CONTINUATION OF SF 1449 BLOCK 18A.

B.1 Contract Administration Data System for Award Management (SAM):

SAM Registration: Offeror must be registered in the System for Award Management (SAM). No contract will be entered into with an unregistered contractor. Internet access allows registration by completing an electronic on-line registration application at https://sam.gov/content/home. The NAICS for this requirement is 621511 (Medical – Laboratories) which has a size standard of $41.5 Million. PSC Q301 (Medical - Laboratory Testing) and Q515 (Medical – Pathology) are relevant to this procurement and shall be listed in the Contractor’s SAM.gov profile.

In accordance with FAR Parts 12 and 15, the Contractor agrees to provide Services in accordance with the terms and conditions stated herein, furnished to/and at the VISN 23 Midwest Health Care System, the services and prices specified in the Sections B.2 (Schedule of Services) and B.3 (Performance Work Statement).

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

a. CONTRACTOR: (Offerors are required to designate a person and their point of contact information for prompt administration).

Name of Company:

Name of Government POC:

Title/Position of Government POC:

Email of Government POC:

Phone Number of Government POC:

Contractor Address:

City/State/Zip:

b. GOVERNMENT: Michael Casper, Contracting Officer (90C)

Network Contracting Office (NCO) 23 3600 30th Street Des Moines, IA 50310 515-699-5999 x5880 Michael.Casper@va.gov

c. Contractor and Government points of contact can be changed by written notification to the other party.

Notification will be placed in the Contract file and shall not require a modification to the Contract.

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be mailed to the following address (Contractor fill in address information below): N/A

3. ELECTRONIC INVOICE SUBMISSION: All Invoices shall be submitted electronically in accordance with VAAR Clause 852.232-72, Electronic Submission of Payment Requests. Invoicing shall be in accordance with the requirements of the Department of Veterans Affairs (VA) Financial Services Center (VA FSC). The attest information shall be used for invoicing and payments and may change during the Period of Performance of this acquisition. Current invoicing information is located at: https://www.fsc.va.gov/einvoice.asp.

A) Tungsten direct vendor support number is 877-489-6135 for VA contracts;

B) The VA-FSC pays all associated transaction fees for VA orders;

C) During Implementation (technical set-up) Tungsten will confirm your Taxpayer ID Number with the VA-FSC;

D) This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment;

https://sam.gov/content/home https://www.acquisition.gov/far/part-12 https://www.acquisition.gov/far/part-15 mailto:Michael.Casper@va.gov https://www.fsc.va.gov/einvoice.asp

E) To successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the “how-to” guides;

F) All invoices submitted through Tungsten to the VA-FSC should mirror the current submission of Invoice, with the following items required.;

G) Clarification of additional requirements should be confirmed with your Certifying Official the Contracting Officer or Contract Specialist.

H) Payments will only be made for actual services rendered;

I) Payments shall be made monthly, in arrears upon receipt of a properly prepared invoice IAW FAR 52.212-4(g), FAR 52.232-33, and VAAR 852.232-72;

J) The Contractor shall be reimbursed at the rate specified in Section B.2 Schedule of Services;

K) The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements;

L) The Contractor shall be reimbursed upon receipt of a proper invoice. Invoices must contain the following information:

a) Total number of listed Veterans from the previous month's invoice;

b) New Veterans added to the billable roster since the previous month's invoice;

c) Veterans removed from the billable roster since the previous month's invoice;

d) Number of Veterans (if any) whose disenrollments generate a credit, the amount of the credit, and the calculation(s) used to arrive at the credit;

e) Firm’s Taxpayer ID Number (TIN);

f) Firm’s “Remit Address” information;

g) The VA Purchase Order (PO) number;

h) Firm’s contact information: (Personal Name, Email, and Phone);

i) VA point of contact information: (Personal Name, Email, and Phone);

j) The Period of Performance dates (Beginning and Ending); and

k) All discount information if applicable (Percent and Date Terms)

M) For additional information, please contact:

1) Tungsten Support:

a) Phone: 1-877-489-6135

b) Website: https://www.fsc.va.gov/einvoice.asp

2) Department of Veterans Affairs Financial Service Center

a) Phone: 1-877-353-9791

b) Email: vafscched@va.gov

4. Type of Contract:

Laboratory Referral Testing Services. 5-Year, Fixed-Price, Indefinite Delivery, Indefinite Quantity Contract.

https://www.fsc.va.gov/einvoice.asp mailto:vafscched@va.gov

B.2 Schedule of Services In accordance with FAR Parts 12 and 15 the Contractor shall provide unit pricing for all Diagnostic Tests listed in (Section D, Attachment 5, 2024 VISN 23 Schedule of Services) for each ordering period in order to be eligible for contract award.

The total extended estimated pricing shall be all-inclusive (including transportation and other associated costs) for each Ordering Period shall be transferred from the (Section D, Attachment 5, 2024 VISN 23 Schedule of Services) and input into the tables below. Tests referred within the Contractor-owned laboratory network or subcontracted laboratories shall be at no additional transfer charge or confirmation charge to the Government.

ORDERING PROCEDURES: This is a Fixed Price (FP), Indefinite Delivery, Indefinite Quantity Contract under C.6 FAR 52.216-22. Actual quantities may vary from the quantities listed in Section D, (Attachment 5 - 2024 VISN 23 Schedule of Services).

The Task Orders shall specify the estimated quantities of services for each Period of Performance to be furnished under this contract and shall comply with C.4 FAR 52.216-18 and C.5 FAR 52.216.19. Any services to be furnished under this contract shall be ordered by issuance of Delivery Orders or Task Orders by the Contracting Officer or Administrative Contracting Officer. Orders may be issued by electric commerce methods.

In Accordance with FAR 16.504(a)(1), The guaranteed minimum and maximum dollar amounts are listed in the table below. These following amounts cover the Minimum and Maximum of the Five-Year Ordering Period. The maximum dollar amounts shall not be exceeded.

IDIQ Established Minimum and Maximum dollar amounts for the Five-Year Ordering Period

Minimum $2,000.00 Maximum $22,500,000.00

Period of Performance: One Ordering Period of Five Years. (November 1, 2024 – October 31, 2029).

Year 1 of Ordering Period, Period of Performance– 11/01/2024-10/31/2025

Line Item Services Total Estimated Cost, Year 1 of Ordering Period

0001 VISN 23 Laboratory Services

Year 2 of Ordering Period, Period of Performance– 11/01/2025-10/31/2026

Line Item Services Total Estimated Cost, Year 2 of Ordering Period

1001 VISN 23 Laboratory

Year 3 of Ordering Period, Period of Performance– 11/01/2026-10/31/2027

Line Item Services Total Estimated Cost, Year 3 of Ordering Period

2001 VISN 23 Laboratory

Year 4 of Ordering Period, Period of Performance– 11/01/2027-10/31/2028

Line Item Services Total Estimated Cost, Year 4 of Ordering Period

3001 VISN 23 Laboratory https://www.acquisition.gov/far/part-12 https://www.acquisition.gov/far/part-15 https://www.acquisition.gov/far/part-52#FAR_52_216_22 https://www.acquisition.gov/far/part-52#FAR_52_216_18 https://www.acquisition.gov/far/part-52#FAR_52_216_19 https://www.acquisition.gov/far/part-16#FAR_16_504

Year 5 of Ordering Period, Period of Performance– 11/01/2028-10/31/2029

Line Item Services Total Estimated Cost, Year 5 of Ordering Period 4001 VISN 23 Laboratory

TOTAL ESTIMATED COST FOR ALL FIVE YEARS OF THE ORDERING PERIOD:

B.3 Performance Work Statement (PWS)

1. GENERAL REQUIREMENTS:

1.1. Services Required: The Department of Veterans Affairs, VISN 23 Midwest Healthcare System, has a requirement for medical laboratory and testing analysis services. The Contractor shall be responsible for performing pre-analytic processing as defined in its laboratory manual, analysis, and reporting of analytical results and interpretation for clinical and anatomical pathology specimens as requested by participating facilities (listed below) during the contract period. Services shall include: testing on a paraffin-embedded tissues, to include consultation, cytology, immunohistochemistry, molecular testing (anatomic pathology), pharmacogenetics, and in-situ hybridization; the transportation of clinical laboratory specimens to the Contractor’s laboratory/laboratories, performance of pre-analytical specimen processing support services, the performance of analytical testing as defined by the Contractor’s reference test manual, the reporting of analytical test results, and consultative services as required to provide the full scope of its laboratory services to the ordering facility. Additional required 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. The Contractor shall provide varying levels of support service depending on the unique characteristics presented by each Medical Center or Outpatient Clinic. Services furnished under the contract shall be ordered by issuance of a task order for results to be delivered to the site designated on the task order, and in accordance with standards, clauses and provisions of this document. The contractor shall supply all necessary laboratory testing supplies, including but not limited to: requisition forms, specimen containers, collection supplies, collection tubes, aliquot tubes, special instructions, specimen carriers, all forms (including chain of custody forms), special media or tubes for viral samples, all supplies for special tests (e.g., viral studies), printers and printer supplies, middleware, software.

1.2. Lab Referral Services: Lab Referral Services will be provided for the Department of Veterans Affairs, VISN 23 Midwest Healthcare System Services for the following participating facilities:

1.2.1. VA Black Hills Health Care System, Hot Springs, SD

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

1.2.3. Sioux Falls VA Health Care System, Sioux Falls, SD

1.2.4. Fargo VA Health Care System, Fargo, ND

1.2.5. VA Nebraska-Western Iowa Health Care System, Omaha, NE

1.2.6. VA Nebraska-Western Iowa Health Care System, Lincoln, NE

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

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

1.2.9. Minneapolis VA Health Care System, Minneapolis, MN

1.2.10. Iowa City VA Health Care System, Iowa City, IA

1.2.11. VA Central Iowa Health Care System, Des Moines, IA

1.3. Authority: FAR Part 12, “Acquisition of Commercial Products and Commercial Services”, FAR Part 15, “Contracting by Negotiation”.

1.4. Policy/Handbooks: The Contractor shall be subject to the following policies and regulations including any subsequent updates during the period of performance of this contract. Copies of most current VA and VHA publications are located at: https://www.va.gov/vapubs/ and http://www.va.gov/vhapublications/.

1.4.1. VA Directive 0710, “Personnel Suitability and Security Program”

1.4.2. VA Directive 6004, “Configuration, Change, and Release Management Programs”

1.4.3. VA Directive 6300, “Records and Information Management”

1.4.4. VA Directive 6371, “Destruction of Temporary Paper Records”

1.4.5. VA Directive 6500, “VA Cybersecurity Program”

1.4.6. VA Directive 6517, “Risk Management Framework for Cloud Computing Services”

1.4.7. VA Directive 6513, “Secure External Connections”

1.4.8. VA Handbook 6300.1, “Records Management Procedures”

1.4.9. VA Handbook 6500, “Risk Management Framework for VA Information Systems, VA

Information Security Program”

1.4.10. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal

Information”

1.4.11. VA Handbook 6500.3, “Certification and Accreditation of VA Information Systems”

1.4.12. VHA Handbook 1106, “Pathology and Laboratory Medicine Service” https://www.acquisition.gov/far/part-12 https://www.acquisition.gov/far/part-15 https://www.va.gov/vapubs/ http://www.va.gov/vhapublications/ https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=487&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1412&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=997&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=742&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1254&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=852&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=475&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1449&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1449&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=11663

1.5. Definitions/Acronyms: Terms used in this Performance Work Statement shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ACEP: American College of Emergency Physicians

1.5.2. AO: Administrative Officer

1.5.3. AES: Advanced Encryption Standard

1.5.4. ANSI: American National Standards Institute

1.5.5. AMA: American Medical Association

1.5.6. CAP: College of American Pathologists

1.5.7. CDC: Centers for Disease Control and Prevention

1.5.8. CDR: Contract Discrepancy Report

1.5.9. CASA: Cisco Adaptive Security Appliance

1.5.10. CLIA: Clinical Laboratory Improvement Act of 1988

1.5.11. CM: Communication Manager

1.5.12. CMS: Centers for Medicare & Medicaid Services

1.5.13. CO: Contracting Officer- The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.14. COR: Contracting Officer’s Representative - A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.15. COTR: Contracting Officer Technical Representative

1.5.16. CPARS: Contractor Performance Assessment Reporting System

1.5.17. CPT: Current Procedural Terminology

1.5.18. C2S: Client to Site

1.5.19. Critical Value: A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to VISN 04 upon request.

1.5.20. Direct Employee: An individual or person who works as an employee of a company and is paid a wage or salary by the company, rather than being employed through an agency, contract or subcontract.

1.5.21. 3DES: Triple Digital Encryption Standard

1.5.22. DMS: Data Management System

1.5.23. Esoteric Test: A test that is similar to specialized tests, except they can only be done in a few laboratories throughout the country.

1.5.24. FOIA: Freedom of Information Act

1.5.25. Frozen Section: A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery.

1.5.26. ESCCB: (VA) Enterprise Change Control Board

1.5.27. EHR: Electronic Health Record – Electronic Health Record system used by the VA

1.5.28. EMR: Electronic Medical Record

1.5.29. HCR: Health Care Resources

1.5.30. HCS: Health Care System

1.5.31. HIPAA: Health Insurance Portability and Accountability Act

1.5.32. HIS: Hospital Information System

1.5.33. HL7: Health Level Seven

1.5.34. HSS: Health System Specialist

1.5.35. IAW: In Accordance With

1.5.36. ICN: Internal Control Number

1.5.37. IDS: Internet Database System

1.5.38. IPSec: Internet Protocol Security

1.5.39. ISA: (VA) Interconnection Security Agreement

1.5.40. ISAKMP: Internet Security Association and Key Management Protocol https://www.acep.org/ https://www.ansi.org/ https://www.ama-assn.org/ https://www.cap.org/ https://www.cdc.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.cms.gov/ https://www.cpars.gov/ https://www.foia.gov/ https://www.hhs.gov/programs/hipaa/index.html

1.5.41. ISO: Information Security Office or Officer

1.5.42. LEDI: (VistA) Laboratory Electronic Data Interchange

1.5.43. LIS: Laboratory Information System

1.5.44. LOINC: Logical Observation Identifier Names and Codes

1.5.45. NARA: National Archives and Records Administration

1.5.46. NSOC: Network Security and Operations Center

1.5.47. OIT: VA Office of Information and Technology

1.5.48. OSHA: Occupational Safety and Health Administration

1.5.49. Overflow: A test usually performed in a VISN 23 laboratory, which might be referred to the Contractor’s laboratory in case of instrument breakdown or other circumstances interfering with the VA’s ability to analyze the specimens.

1.5.50. Paraffin Block: A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.

1.5.51. POC: Point of Contact

1.5.52. POP: Period of Performance

1.5.53. PWS: Performance Work Statement

1.5.54. Proficiency Testing: An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by many other labs. The proficiency survey is conducted by an organization or agency authorized by HHS to do so.

1.5.55. QA/QI: Quality Assurance/Quality Improvement

1.5.56. QC: Quality Control

1.5.57. QASP: Quality Assurance Plan

1.5.58. QM/PI: Quality Management/Performance Improvement

1.5.59. RA: Regulatory Agency

1.5.60. Reference or Referral Laboratory: The contract laboratory that provides testing, and examination of specimens provided by the VA.

1.5.61. Reference Value: A range of test values expected for a designated population of individuals.

1.5.62. RFP: Request for Proposal

1.5.63. Routine Test: A test that is usually performed at high volume in which the result is required in 24 hours generally.

1.5.64. Slides: Glass surface containing biological material to be analyzed.

1.5.65. Special Handling: Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time.

1.5.66. Specialized Test: A test that is performed in low volume but the technology, expense, or time-consuming nature of each test, is such that some delay is expected. However, results should be received within a reasonable amount of time to meet patient care needs. The delay usually occurs to allow tests received from different enters to be batch to make the operation cost effected.

1.5.67. Specimen: A body fluid or tissue sample removed for medical examination and analytical testing.

1.5.68. STAT: A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases.

1.5.69. Surgical Specimen: A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing.

1.5.70. S2S: Site-to-Site

1.5.71. TAT: Turnaround Time - The length of elapsed time between pick-up or dispatch of specimen from the contractor’s laboratory until the receipt of the completed printed/ electronically transmitted report back in the lab.

1.5.72. Tests: Diagnostic assays to evaluate a patient's physiological condition.

1.5.73. TIC: Trusted Internet Connection

1.5.74. TJC: The Joint Commission

1.5.75. VA BHHCS: The Department of Veterans Affairs, VA Blacks Hills Health Care System

1.5.76. VA NWIHCS: The Department of Veterans Affairs Medical Center, Nebraska-Western

Iowa Health Care System.

1.5.77. VAMC: Veterans Affairs Medical Center

1.5.78. VHA: Veterans Health Administration - The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

https://www.archives.gov/ https://digital.va.gov/office-of-information-and-technology/ https://www.osha.gov/ https://www.jointcommission.org/ https://www.va.gov/black-hills-health-care/ https://www.va.gov/nebraska-western-iowa-health-care/ https://www.va.gov/nebraska-western-iowa-health-care/ https://www.va.gov/health/

1.5.79. VISN: Veterans Integrated Services Network - The regional oversight for the VA medical centers

1.5.80. VistA: Veterans Integrated Systems Technology Architecture - A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system

1.5.81. VISN 23: VA Midwest Health Care Network

1.5.82. VPN: Virtual Private Network

1.5.83. WAN: Wide Area Network

2. CONTRACTOR QUALIFICATIONS:

2.1. Licensing and Accreditation:

2.1.1. The Contractor shall have and maintain all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP), The Joint Commission or (other Accreditation Body). In addition, the laboratory must be certified and maintain certifications meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2.1.2. The Contractor shall provide a copy of all current, relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award including, but not limited to any State, Federal, Commonwealth, Territory, Local agencies as required by law or regulation of the United States or the District of Columbia. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all Subcontractors have and maintain appropriate licensure and accreditation for the duration of this contract to perform tests that the primary Contractor cannot perform prior to contract award. Changes to the requirements shall be addressed by bilateral modification.

2.1.3. Contractor Personnel assigned by the Contractor to perform the requirements covered by this PWS shall be eligible to provide the services of this contract and licensed in a State, Federal, Commonwealth, Territory, Local agencies as required by law or regulation of the United States or the District of Columbia. Contractor/Contractor Personnel working on this contract shall obtain and maintain all licenses, permits, accreditation and certificates (required by law or by the governing or cognizant licensing board).

2.2. Key Personnel: The Contractors' Laboratory Director, Medical Technologists, Medical Technicians, Cytotechnologists and Pathologists shall meet and maintain the Personnel qualifications required by CLIA. Further, the Contractor will provide evidence of the Contractors’ current compliance thereof. All Staff shall be appropriately licensed/accredited by the College of American Pathologists (CAP), The Joint Commission or (other Accreditation Body). In addition, the laboratory must be certified and maintain certifications meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988

2.2.1. Pathologists: The Contractor shall provide and maintain a minimum of one (1) Pathologist who will regularly consult with VA Pathologists and other associated Healthcare Providers at the participating facilities cited in Section 1.2. The Contractors Pathologists shall have graduated from an approved School of Medicine or Osteopathy; and shall have completed a residency or fellowship in Pathology acceptable to the United States Surgeon General and shall possess a valid license to practice clinical reference laboratory services from a United States jurisdiction.

2.2.1.1. Proposed Pathologists shall be a direct employee of the Contractor, or shall have an executed Letter of Intent witnessed by a Notary Public or Jurat to on-board with the Contractor immediately upon Contract Award for a duration of no less than one (1) year.

2.2.2. The Contractor shall provide the following information prior to contract award, and upon proposed change of any Key Personnel:

2.2.2.1. Pathologists shall have provided Pathology Services a minimum of 24 months within the past 36 months and Pathology Consultation Services a minimum of 36 months within the past 48 months.

2.2.2.2. Curricula Vitae, (Not to Exceed 2 pages), Technical Staff Competency Skills Assessment, CAP and or any Proficiency Exam participation for the last two (2) years, Proficiency Examination Exception Reports for the past two (2) years https://www.va.gov/HEALTH/visns.asp https://www.va.gov/directory/guide/region.asp?ID=23 https://www.cap.org/ https://www.cap.org/ https://www.hhs.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.cap.org/ https://www.hhs.gov/ https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.congress.gov/bill/100th-congress/house-bill/5471/text

2.3. CLIA Credentials:

2.3.1. The Contractor (or their Subcontractor) shall have, maintain, and provide evidence of certifications for the following CLIA Specialty or Subspecialties which are required for the Scope of Testing under the resultant contract.

2.3.1.1. Histocompatibility: Transplant, Nontransplant

2.3.1.2. Microbiology: Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology

2.3.1.3. Immunohematology(ABO & RH Group): Antibody Detection (Transfusion), Antibody Detection (Nontransfusion), Antibody Identification, Compatibility Testing, Transfusion Services, Hematopoietic Progenitor Cell, Donor Services, Tissue Storage and Issue, Therapeutic Phleb (Lab), Therapeutic Phleb (Non-Lab)

2.3.1.4. Diagnostic Immunology: Syphilis Serology, General Immunology

2.3.1.5. Chemistry: Routine, Urinalysis, Endocrinology, Toxicology, Blood Gas

2.3.1.6. Hematology: General Hematology, Coagulation, Body Fluid Analysis

2.3.1.7. Pathology: Histopathology, Oral Pathology, Cytology – Non-GYN, Cytology – GYN, Cytology Screening, Molecular Pathology, Electron Microscopy, Autopsy

2.3.1.8. Flow Cytometry

2.3.1.9. Radiobioassay

2.3.1.10. Clinical Biochemical Genetics

2.3.1.11. Clinical Cytogenetics

2.3.1.12. Mohs Surgery

2.3.1.13. PPMP

2.3.2. The Contractor is responsible to ensure that all personnel possess the requisite credentials to practice at the full performance level of their profession. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor, or any discovery of any disciplinary action taken against laboratory/laboratories performing under the contract within 24 hours of notification of an investigation or suspension.

2.3.3. The Contractor shall have and maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification. The Contractor shall provide a copy of the renewed licenses to the Contracting Officer before expiration.

2.4. Professional Liability Insurance: The Contractor shall provide and maintain professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage. Additionally, the Contractor shall follow the Insurance limits within C.10 Supplemental Insurance Requirements.

2.5. Conflict of Interest: The Contractor and all Contractor’s employee(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest and fully outlined in response to the subject attachment in Section D (Attachment 4) of the solicitation document.

2.6. Citizenship Related Requirements:

2.6.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, Section D (Attachment 3), 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.

https://www.congress.gov/bill/100th-congress/house-bill/5471/text https://www.acquisition.gov/vaar/852.209-70-organizational-conflicts-interest.?searchTerms=852.209-70 https://www.uscis.gov/laws-and-policy/legislation/immigration-and-nationality-act

2.6.2. 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 of 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.

2.6.3. 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 sole 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.

2.6.4. The Immigration and Nationality Act 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 certifier (individual authorized to bind the contractor to subject to prosecution under 18 U.S.C. 1001).

2.6.5. 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 (Section D, Attachment 3) of the solicitation document.

3. CONTRACT REQUIREMENTS

3.1. INTERFACING/COMMUNICATION REQUIREMENTS:

3.1.1. The Contractor shall provide an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing and reporting. As such, the Contractor shall provide and program an interface system to electronically transmit orders, specimen status and test results between the Contractor’s host computer system and the VA’s host computer system (VistA).

3.1.2. The Contractor shall have an operational interface connection with all facilities within 30 days of the contract award. The establishment of the test menu will be the responsibility of the Government and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmission through the interface connection will be the joint responsibility of the Government and Contractor.

3.1.3. The expense of the electronic interface leading from the Contractor’s LIS up to the VA VISTA HIS and/or middleware solution is borne by the Contractor. This many include, but is not limited to: Virtual Server Platforms, software licenses, and annual maintenance costs. The Contractor is responsible for data being communicated from the Contractor correctly according to VA protocols, as well as the accuracy checks.

3.1.4. All electronic messaging between the two (Contractor and VistA) computer systems shall conform to VistA Health Level Seven (HL7) and Laboratory’s HL7 technical specifications.

Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, is a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc website, www.HL7.org. All messaging protocols, either by direct to VistA interface or by middleware solutions, shall conform to the current VA Lab Electronic Data Interface (LEDI) standards. Refer to Sections 3.3 and 3.4 below for additional information.

3.1.5. Data connectivity between the Contractor and the VA will be accomplished through the use of either a Client to Site (C2S) connection, Site to Site (S2S) connection or via the VA’s Private Extranet Internet Cloud according to standards required by the VA’s Network Security and Operations Center (NSOC) and as approved by the VA’s Enterprise Change Control Board (ESCCB) in accordance with VA Directive 6004, “Configuration, Change, and Release Management Programs”, VA Directive 6513, “Secure External Connections”, VA Directive 6517, “Risk Management Framework for Cloud Computing Services” , VA Handbook 6500, “Risk Management Framework for VA Information Systems, VA Information Security Program” (or subsequent release), requirements. These requirements are consistent with VA Policy, National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Any software needed to run on VA systems shall https://www.e-verify.gov/ https://www.govinfo.gov/content/pkg/WCPD-1996-02-19/pdf/WCPD-1996-02-19-Pg281.pdf https://www.govinfo.gov/content/pkg/WCPD-1996-02-19/pdf/WCPD-1996-02-19-Pg281.pdf https://uscode.house.gov/view.xhtml?req=49&f=treesort&num=1262 http://www.hl7.org/ https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1412&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1412&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=852&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=852&FType=2 meet Technical Resource Model (TRM) and Enterprise Risk Assessment (ERA) requirements.

Pursuant to VA Memorandum, "VA TRM Announcement (WebCIMS# 447341)", dated January 11, 2010, and Veterans Affairs (VA) approval process for use of Technical Reference Model (TRM) (Section D, Attachment 6), and VA Updated Security Requirement for Network Connected Medical Devices and Systems (VAIQ# 7566605) (Section D, Attachment 7).

3.1.6. If direct access to VA Systems is required by the Contractor (ie. Without direct supervision by VA Staff, the Information Security Office will coordinate the requirements with the Contracting Officer Representative (COR) and the Contractor POC for the supporting the contract. Connections are by Site-to-Site VPN, and the Contractor will bear all responsibility for completing and maintaining all VA requirements. When all requirements are met, Business Partners may access designated internal VA servers if they are granted a Client VPN account. A Client VPN requires signing of VA National Rules of Behavior and VPN Rules of Behavior by each approved user of the connection. However, if there is a large number of Business Partner users that are approved for this, it may be more efficient to build a Site to Site (S2S) VPN with the Business Partner.

3.1.6.1. Each type of connection (C2S or S2S) requires that all contractors must have

Background Investigations completed as required by FIPS 201-3; and must initially and annually thereafter participate in the VA Information Security Awareness and VA Privacy training programs.

3.1.6.2. A Site-to-Site VPN enables a VA Business Partner (Contractor) to securely access specific resources on the VA WAN. It does this by establishing a Virtual Private Network (VPN) connection between the Business Partner network and one of the VA Trusted Internet Connection (TIC) Internet Gateways. Traffic that may pass over this connection is limited, so only specific VA and Business Partner systems may communicate with each other. A S2S is used only if business needs cannot be met with a Client to Site VPN connection. The Business Partner must support encryption that is compliant with FIPS 140-2. It is preferred, that the Business Partner have a legal agreement with the VA (Interconnection Security Agreement (ISA), Memorandum of Understanding (MOU) (MOU-ISA) for a S2S in place; however, if the Contractor does not currently have a MOU-ISA in place, they must have one executed within 45 days of contract award . Communication must be limited to explicit VA and Business Partner systems, using a limited set of ports, protocols and services. A S2S requires an ISA, used to support an MOU that establishes the requirements for data exchange between two organizations. The MOU is used to document the business and legal requirements necessary to support the business relations between the two organizations.

3.1.6.3. Each of the VA TIC gateways has Cisco Adaptive Security Appliance (ASA) devices used for Site-to-Site VPN connections. They use IP Security (IPSec) with Triple Digital Encryption Standard (3DES) or Advanced Encryption Standard (AES) for encryption and Internet Security Association and Key Management Protocol (ISAKMP) for authentication and integrity. The devices are FIPS 140-2 compliant.

This capability establishes a secure, end-to-end encrypted tunnel that protects the report Gateway VPNs are configured to allow only Internet Protocol Security (IPSec) protected data flows, and only when originated from and sent to authorized peers. The Business Partner must use a FIPS 140-2 compliant solution for their end of the Site-to- Site VPN. If they do not already have a VPN solution in place, the vendor will work with VA Information Security, Network Security Operations Center (NSOC) and the Enterprise Security Change Control Board (ESCCB) to establish the appropriate VPN connection type. The VA is not responsible for problems with equipment owned by the Business Partner.

3.2. The Contractor shall provide electronic access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital Information System (HIS) or current Government Laboratory Information System (LIS). After contract award and annually thereafter, the contractor and/or subcontractors shall provide to the VA all necessary laboratory test parameters to insure accurate test result transmission between the VA and the vendor’s database. Required test parameters to include are as follows:

3.2.1. Test name (including synonyms)

https://csrc.nist.gov/pubs/fips/201-3/final https://csrc.nist.gov/pubs/fips/140-2/upd2/final https://csrc.nist.gov/pubs/fips/140-2/upd2/final https://csrc.nist.gov/pubs/fips/140-2/upd2/final

3.2.2. Ordering code

3.2.3. Billing code (if separate from the orderable test code)

3.2.4. LOINC code – Logical Observation Identifier Names and Codes

3.2.5. CPT code – Current Procedural Terminology

3.2.6. Interface code/Test Mapping

3.2.7. Test cost

3.2.8. Test Description information, including reference ranges (when appropriate, age and sex adjusted) and units of measurement

3.2.9. Therapeutic or diagnostic reference ranges (when appropriate)

3.2.10. Reference ranges

3.2.11. Units of measurement

3.2.12. Test result interpretation or interpretive remarks (if appropriate)

3.2.13. Testing site (if not performed at the vendor’s main laboratory facility, this needs to be indicated)

3.2.14. Test methodology

3.2.15. Specimen type

3.2.16. Specimen collection and handling requirements, to include minimum volume of specimen required.

3.2.17. Testing Schedule (days tests will be performed)

3.2.18. Whether test is a panel or profile test, (list tests included if panel)

(*NOTE: Above parameters are required for each test contained in a panel*)

3.3. The parameters for all tests in the Contractor’s database shall be kept current and be available in electronic format to the VA sites throughout the performance period of the contract; preferably in a website portal.

Updates to the test parameter information must be provided to VA sites prior to any testing changes in the following situations: new tests are developed and introduced into the Contractor’s test menu; testing parameters have changes; or when tests are discontinued or replaced by other tests. The contractor shall provide information to VA sites no less than 2 weeks prior to the implementation of the test change.