S02 - 36C26322R0024.pdf

PAGE 1 OF 80 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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C26322R0024

Erica Morris 651-293-3053 2-7-2022

15:00 CST

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Erica Morris 316 Robert Street N. STE. 506 St. Paul MN 55101

X

621511

$35 Million

Net 30 N/A

X

Department of Veterans Affairs VA Nebraska-Western Iowa Health Care System 4101 Woolworth Ave, Suite 4199

Omaha NE 68105

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Erica Morris 316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

Offsite Pathology Services for the Nebraska Western Iowa VA Health Care System.

See Price/Cost Schedule on page 5.

See Performance Work Statement on page 6.

X 1

Erica Morris Contracting Office

1-4-2022

36C26322R0024

Table of Contents

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

B.3 PERFORMANCE WORK STATEMENT (PWS)

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

C.2 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT

(NOV 2021)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

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

1984)

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.12 VAAR 852.237-72 CRIME CONTROL ACT—REPORTING OF CHILD ABUSE

(OCT 2019)

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1. ATTACHMENT 1 – LINE ITEM NUMBER PRICING

D.2. ATTACHMENT 2 - QASP

D.3. ATTACHMENT 3 – ORGANIZATIONAL CONFLICT OF INTEREST

D.4. ATTACHMENT 4 – VA RULES OF BEHAVIOR

D.5. ATTACHMENT 5 – IMMIGRATION AND NATIONALITY ACT REQUIREMENT ...54

D.6. ATTACHMENT 6 – MEDICAL STAFF BYLAWS

D.7. ATTACHMENT 7 – COMPLIANCE & BUSINESS INTEGRITY PROGRAM POLICY

D.8. ATTACHMENT 8 – COLLABORATIVE CARE AGREEMENT

36C26322R0024

D.9. ATTACHMENT 9 – BLOOD BORNE PATHOGEN EXPOSURE CONTROL PLAN

D.10. ATTACHMENT 10 – PHYSICIAN QUALIFICATION STANDARD

D.11. ATTACHMENT 11 – CORRECTIVE ACTION FOR DELINQUENT MEDICAL

RECORDS

D.12. ATTACHMENT 12 – VA HANDBOOK 6500.6 APPENDIX C

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES—

REPRESENTATION (OCT 2020)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 852.273-73 EVALUATION – HEALTH-CARE RESOURCES (JAN 2003)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Erica Morris 316 Robert Street N. STE. 506 St. Paul MN 55101

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award

Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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

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

Amendment No Date

363C26322R0024

B.2 PRICE/COST SCHEDULE

The contractor shall furnish all personnel, supplies, facility and equipment to provide services necessary to perform Pathology and Laboratory Medicine services during normal business hours to eligible beneficiaries of the Department of Veterans Affairs, Nebraska Western Iowa Veterans Affairs Health Care System (NWIVAHCS).

Period of Performance: One Five-Year Ordering Period (April 1, 2022 – March 31, 2027) Year One of Ordering Period: April 1, 2022 – March 31, 2023 Year Two of Ordering Period: April 1, 2023 – March 31, 2024 Year Three of Ordering Period: April 1, 2024 – March 31, 2025 Year Four of Ordering Period: April 1, 2025 – March 31, 2026 Year Five of Ordering Period: April 1, 2026 – March 31, 2027 The pricing for individual Line Item Numbers (LINs) is included in Attachment 1 in Section D (LIN Pricing). The table below shows the estimated total for each of the years of the ordering period:

Period of Performance Estimated Total Price for All LINs

Year One of Ordering Period April 1, 2022 – March 31, 2023 LINs: 0001 – 0309

Year Two of Ordering Period April 1, 2023 – March 31, 2024 LINs: 1001 – 1309

Year Three of Ordering Period April 1, 2024 – March 31, 2025 LINs: 2001 – 2309

Year Four of Ordering Period April 1, 2025 – March 31, 2026 LINs: 3001 – 3309

Year Five of Ordering Period April 1, 2026 – March 31, 2027 LINs: 4001 – 4309

Estimated Total for the Five-Year Ordering Period

In accordance with FAR 16.504(a)(1), the guaranteed minimum and maximum dollar amounts are listed in the table below. These amounts cover the base and all option periods of the contract. The maximum dollar amount listed shall not be exceeded. IDIQ established minimum and maximum dollar amounts for the five-year ordering period:

Minimum $25,000.00 Maximum $6,975,000.00

B.3 PERFORMANCE WORK STATEMENT (PWS)

GENERAL:

1.1. Services Required: The Department of Veterans Affairs, Nebraska Western Iowa Health Care System (NWIHCS), requires a contractor to provide Pathology and Laboratory Medicine Services, on a scheduled basis, in accordance with the specifications, terms and conditions herein. VA will be responsible for specimen collection, preparation, grossing (with the exception of cytology specimens), VistA accessioning, preservation and storage of final slides and blocks. All slides and blocks must be returned to the VA for permanent storage.

1.1.1. Regulatory Compliance: Contractor shall be responsible for maintaining contractor’s facility in regulatory compliance with respect to VA, Federal and State regulatory agencies including but not limited to: VA Office of Inspector General (OIG), Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) as well as to accrediting entities such as but not limited to College of American Pathologists (CAP), American Association of Blood Bankers (AABB), Occupational Safety and Health Administration (OSHA) and The Joint Commission (TJC). These responsibilities include, but are not limited to, assuring acceptable levels of risk for Veteran safety, maintaining adequate quality of services to facility providers and their Veterans, and working with VA to minimize inappropriate utilization of laboratory resources through utilization review and consultation. Contractor shall be required to report all findings and actions to the VA periodically to assure contractor and VA compliance with regulations and by-laws.

1.1.2. Courier Service: Contractor shall provide a courier service between contractor’s facility and the following VA sites (at the designated location) to include, but not be limited to: Omaha VA Medical Center, Lincoln Community Based Outpatient Clinic and Grand Island Community Based Outpatient Clinic.

The courier service shall include, but is not limited to: one or more vehicles, fuel, drivers, AND LIABILITY insurance, maintained to assure continuity of service.

1.1.3. Facilities: The contractor shall provide and maintain facilities including, but not limited to: buildings, utilities, environmental control, communications, and information systems for the execution of professional services in such a state as to assure continuity and level of quality required to maintain regulatory compliance. The right is reserved to thoroughly inspect and investigate the establishment, facilities, business reputation and other qualifications of any bidder and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Contractor shall be in compliance with VA Handbook 6500.6, Appendices B and C (See Section D).

1.1.4. Equipment: The contractor shall provide and maintain laboratory testing instruments and other ancillary equipment at contractor’s site in support of professional services in such a state as to assure continuity and level of quality required to maintain regulatory compliance. Equipment provided by the Contractor for use at the VA NWI facility will be returned to the Contractor when requested, or at the end of the contract.

1.1.5. Supplies: The contractor shall provide all supplies necessary to support professional services in such quantities and state of condition as to assure continuity of said services to the facility’s practitioners at a level of quality required to maintain regulatory compliance. This includes all materials necessary to collect, preserve, transport (this includes containers of various sizes for the specimens, collection containers (of such quality that specimens will not be compromised, e.g., polypropylene)/kits for both surgical and cytopathology specimen(s) immunofluorescent preservative, EM fixative, flow cytometry preservative, etc.), and process specimens examined at the contractor’s facility as part of the provision of the professional services. A detailed list is provided below:

NWIHCS - Omaha Division Histology Supplies

Item Furnished by:

Item Furnished by:

10 mL Formalin filled containers Contractor Bluing Reagent VA

30 mL Formalin filled containers Contractor Cytoseal VA Cytolyt Contractor Eosin VA Pap Kits Contractor Glacial Acetic Acid VA Tissue Media - Flow Contractor Hematoxylin VA 4 oz. Containers (to be approved by the VA) Contractor Methylbutane VA 8 oz. Containers (to be approved by the VA) Contractor OCT Compound VA 16 oz. Containers (to be approved by the VA) Contractor Quik - Diff VA 32 oz. Containers (to be approved by the VA) Contractor Xylene VA 64 oz. Containers (to be approved by the VA) Contractor Cotton Tipped Applicators VA 86 oz. Containers (to be approved by the VA) Contractor Cover Glass VA 5.7L Containers (to be approved by the VA) Contractor Frosted Slides VA Blue Cassettes Contractor Reagent Grade Alcohol VA Case of Paper per month – to be delivered to the VA NWIHCS Pathology Department by the 1st business day of each month (required for the reports/results/ information faxed to the VA).

Contractor 70% Alcohol VA

Gloves VA Sleeve Covers VA Gowns VA Aprons VA Masks VA Face Shield VA Boot Covers VA Dissection Instruments VA Decal Solution VA Ink - Black VA Ink - Blue VA Ink - Red VA Ink - Yellow VA Ink - Green VA Ink - Orange VA Blue Biopsy Pads VA Cytogenetics Forms VA Double Edged Blades VA

NWIHCS - Omaha Division Histology Supplies

Item Furnished by:

Item Furnished by:

Scalpel Blades VA Scalpel Handles VA Weigh Boats 4" VA Bulk Formalin VA

1.1.6. Personnel: The contractor shall provide all personnel necessary at contractor’s site to support technical services in such number and level of professional experience as to assure continuity and level of quality as established by this facility to meet regulatory requirements by VA and TJC regulations. In addition, contractor shall have available at all times an adequate number of properly trained, boarded, and credentialed professional personnel to provide onsite services as necessary to support the VA facility mission.

1.1.7. Oversight: To the degree the contractor maintains authority over its personnel, in cooperation with the VA, the contractor shall provide all necessary administrative and personnel management resources to maintain appropriate professional behavior to ensure continuity and level of quality as established by this facility to meet regulatory requirements by VA and TJC regulations. In addition, the contractor will be responsible through an appointed medical director to provide supervisory oversight to personnel at contractor’s facilities.

1.2. Term of Contract: The contract will be an indefinite delivery indefinite quantity (IDIQ) contract with a five-year ordering period.

1.3. Availability of Funds: The contract is subject to the availability of annually appropriated funds.

1.4. Authority: Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority, FAR Part 12, and VAAR 873.

1.5. Policy and Regulations: Contractor shall comply with all applicable policies and regulations, including, but not limited to, the following:

1.5.1. VA Directive 1663: Health Care Resources Contracting – Buying:

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.5.2. VHA Handbook 1100.17: National Practitioner Data Bank Reports:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.5.3. VHA Handbook 1100.18 Reporting and Responding To State Licensing Boards:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.5.4. VHA Handbook 1100.19 Credentialing and Privileging:

https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.asp x?DocumentId=4214759&FileName=36C25518Q0329-003.pdf

1.5.5. VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

1.5.6. VHA Handbook 1907.01 Health Information Management and Health Records:

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.5.7. Privacy Act of 1974 (5 U.S.C. 552a) as amended

http://www.justice.gov/opcl/privstat.htm https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4214759&FileName=36C25518Q0329-003.pdf https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4214759&FileName=36C25518Q0329-003.pdf https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 http://www.justice.gov/opcl/privstat.htm

1.5.8. VHA Directive 2009-032: Notification of Medical Malpractice (Tort) Claims Against Licensed Practitioners https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.asp x?DocumentId=361153&FileName=VA263-12-R-0372-005.PDF

1.5.9. VA Handbook 6500.6, Appendices B and C (attached)

1.5.10. VHA Compliance and Business Integrity (CBI) Contractor Handout (attached)

1.5.11. Cancer Protocol Templates https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates

1.6. Definitions and Acronyms:

1.6.1. AABB: American Association of Blood Bankers

1.6.2. ACO: Administrative Contracting Officer

1.6.3. ADP: Automated Data Processing

1.6.4. ANSI: American National Standards Institute

1.6.5. AP: Anatomical Pathology

1.6.6. ASC: Accredited Standards Center

1.6.7. ASCP: American Society for Clinical Pathology

1.6.8. BAA : Business Associate Agreement

1.6.9. BBA: Balanced Budget Act

1.6.10. C&A: Certification and Accreditation (Authorization)

1.6.11. CAMPEP: Commission on Accreditation of Medical Physics Educational Programs

(http://www.campep.org/default.asp)

1.6.12. CAP: College of American Pathology

1.6.13. CBOC: Community Based Outpatient Clinic

1.6.14. CDC: Centers for Disease Control and Prevention

1.6.15. CEU: Certified Education Unit

1.6.16. CFR: Code of Federal Regulations

1.6.17. CLIA: Clinical Laboratory Improvement Amendment

1.6.18. CME: Continuing Medical Education

1.6.19. CMP: Civil Monetary Penalty

1.6.20. CMS: Centers for Medicare and Medicaid Services

1.6.21. 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.

1.6.22. 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.

1.6.23. COS: Chief of Staff

1.6.24. CP: Clinical Pathology

1.6.25. CPARS: Contractor Performance Assessment Reporting System

1.6.26. CPT: Current Procedural Terminology

1.6.27. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

1.6.28. DEA: Drug Enforcement Agency

1.6.29. DOB: Date of Birth

1.6.30. DOD: Department of Defense

1.6.31. EDI: Electronic Data Interchange

1.6.32. EPA: Economic Price Adjustment

https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=361153&FileName=VA263-12-R-0372-005.PDF https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=361153&FileName=VA263-12-R-0372-005.PDF https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates http://www.campep.org/default.asp

1.6.33. FAPIIS: Federal Awardee Performance and Integrity Information System

1.6.34. FAR: Federal Acquisition Regulation

1.6.35. FDA: Food and Drug Administration

1.6.36. FISMA: Federal Information Security Management Act

1.6.37. FSC: Financial Services Center

1.6.38. FTCA: Federal Tort Claims Act

1.6.39. HCR: Health Care Resources

1.6.40. GYN: Gynecological

1.6.41. HEDIS: Health Plan Employer Data and Information Set

1.6.42. HHS: Department of Health and Human Services

1.6.43. HIPAA: Health Insurance Portability and Accountability Act

1.6.44. IDIQ: Indefinite Delivery Indefinite Quantity

1.6.45. ISO: Information Security Officer

1.6.46. LIS: Laboratory Information System

1.6.47. NCQA: National Committee for Quality Assurance

1.6.48. NACI: National Agency Check with Inquiries

1.6.49. NIST: National Institute of Standards and Technology

1.6.50. NPI: National Provider Identifier: NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.6.51. NWIHCS: Nebraska-Western Iowa Healthcare System

1.6.52. OIG: Office of Inspector General

1.6.53. OMB: Office of Management and Budget

1.6.54. OSHA: Occupational Safety & Health Administration

1.6.55. PHI: Protected Health Information

1.6.56. P&LMS: Pathology and Laboratory Medicine Services

1.6.57. POP: Period of Performance

1.6.58. PPIRS: Past Performance Information Retrieval System

1.6.59. PWS: Performance Work Statement

1.6.60. QASP: Quality Assurance Surveillance Plan

1.6.61. RFP: Request for Proposal

1.6.62. SF: Standard Form

1.6.63. SOI: Security Office Identifier

1.6.64. SON: Submitting Office Number

1.6.65. SSN: Social Security Number

1.6.66. TC: Technical component (CMS pricing) of a service or procedure and includes the cost of equipment and supplies to perform that service or procedure.

1.6.67. TJC: The Joint Commission

1.6.68. USC: United States Code

1.6.69. VA: Department of Veterans Affairs

1.6.70. VAMC: Veterans Affairs Medical Center

1.6.71. VetPro: A federal web-based credentialing program for healthcare providers

1.6.72. 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.

1.6.73. VISN: Veterans Integrated Services Network. The regional oversight for the VA Medical Centers.

1.6.74. VISTA: Veterans Health Information Systems and 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.

1.6.75. Working Day: A Regular Federal Workday. It does not include Saturdays, Sundays or Federal Holidays.

2. QUALIFICATIONS:

2.1. All professionals providing services under the terms of this contract will be appropriately certified and/or licensed as described herein and possess the requisite skills and experience to perform P&LM services. The contractor will be responsible for ensuring that contractor employees performing work on this contract are fully trained and competent to perform the required work. The contractor is required to develop and maintain the following documents for each contractor employee working on the contract: credentials and qualifications for the job; a current competency assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; includes knowledge and skills required to provide care for certain patient populations, as appropriate); a current performance evaluation supporting ability of the contractor employee to successfully perform the work required in this solicitation; a list of relevant continuing education for the last two years, and a current provider license is required. Contractor will ensure that VA NWIHCS always has a current copy of provider license(s).

2.1.1. License: All licenses held by the contractor staff working on this contract shall have a full and unrestricted valid medical license to practice medicine in a state, Territory or Commonwealth of the U.S. or in the District of Columbia. The physician must maintain a current registration in the State of licensure if this is a requirement for continuing active/current licensure. Contractor staff must submit evidence of at least one full, active, current and unrestricted licensure, registration, certification, and/or other relevant credentials, for verification prior to appointment and throughout the employment process, as requested by the Contracting Officer’s Representative (COR). Contractor is responsible for keeping the VA COR apprised of anything that would adversely affect or otherwise limit their clinical privileges. NOTE: Failure to keep VA fully informed on these matters may result in administrative or disciplinary action.

2.1.2. Board Certification/Eligibility:

2.1.2.1 All contract Pathologists must have current American Board of

Pathology specialty and/or subspecialty certification (AP/CP certification is preferred). Certification must be maintained throughout the course of the contract. All continuing education courses required for maintaining certification must be kept up to date at all times.

Documentation verifying current certification must be provided by the contractor on an annual basis.

2.1.2.2. Cytotechnologists must be American Society for Clinical Pathology (ASCP) certified.

2.1.3. Technical Proficiency: Contractors shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor will provide documents as needed to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Education: Contractor staff must possess a degree of Doctor of Medicine or an equivalent degree resulting from a course of education in medicine or osteopathic medicine. The degree must have been obtained from one of the schools approved by the Secretary of Veterans Affairs for the year in which the course of study was completed. Reference: VA Handbook 5005/27, Part II, Appendix G-2 Physician Qualification Standard (paragraph 2b):

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1006&FType=2

2.1.4. Continuing Medical Education (CME)/Certified Education Unit (CEU) Requirements: Contractor will provide the COR copies of current CMEs/CEUs as required or requested by the VA NWIHCS. Contractors registered or certified by national/medical associations shall continue to meet the minimum standards for CMEs/CEUs to remain current. For contractor personnel, who are credentialed and privileged (required if have access to VA system), CME/CEU hours shall be reported to the VA NWIHCS Credentialing office for tracking.

These documents are required for both privileging and re-privileging. Failure to provide will result in loss of privileges.

2.1.5. Conflict of Interest: The contractor and all contractor staff 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 (sample attached) 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 sub-contractors 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.

2.1.6. Citizenship-Related Requirements:

2.1.6.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, 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.

2.1.6.2. 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 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.

2.1.6.3. 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 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 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1006&FType=2 place of business that services Department of Veterans Affairs patient referrals; or other place(s) 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.

2.1.6.4. 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.

2.1.6.5. 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 attachment in Section D.

2.1.7. Annual Office of Inspector General (OIG) Statement:

2.1.7.1. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the VA 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/or Medicaid programs.

2.1.7.2. All contractors shall review the OIG List of Excluded Individuals/Entities on the OIG website at https://oig.hhs.gov/exclusions/ to ensure that the proposed contractors and/or firm(s) are not listed. Contractors 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 or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

2.1.7.3. By submitting their proposal, the contractor certifies that the OIG List of Excluded Individuals/Entities has been reviewed and that the contractors and/or firm(s) are not listed as of the date the offer/bid was signed.

2.1.8. Credentialing and Privileging (required for contractor personnel who need to have access to VA system): Credentialing and privileging will be done in accordance with the provisions of VHA Handbook 1100.19. This VHA Handbook provides updated VHA procedures regarding credentialing and privileging, to include incorporating: VHA policy concerning VetPro; the Expedited Medical Staff Appointment Process; credentialing during activation of the facility Disaster Plan; requirements for querying the Federation of State Medical Boards (FSMB); credentialing and privileging requirements for Telemedicine and remote health care; clarifications for the Summary Suspension of Privileges process in order to ensure both patient safety and practitioner rights; and the credentialing requirements for other required providers. Contractor will furnish providers who are credentialed and privileged by the VA NWIHCS in accordance with Medical Staff Bylaws, Rules and Regulations (See Section D). Physicians will practice within the scope of practice in accordance with their credentialing and privileging.

2.1.8.1. Contractor will ensure that all physicians under this contract complete credentialing and privileging through the VA’s computerized https://oig.hhs.gov/exclusions/ credentialing system (VetPro). No services will be provided by any contract physician prior to obtaining approval by the VA Medical Staff Credentials Committee, Executive Committee of the Medical Staff and Director. The contractor will be provided copies of current requirements and updates as they are published.

2.1.8.2. Privileges will require renewal at least every two (2) years in accordance with Medical Center and The Joint Commission (TJC) requirements. Physicians assigned by the contractor to report results in the VA medical records will be required to report specific patient outcome information, such as complications, to the Service Chief.

Quality Improvement data provided by the physicians and/or collected by the services will be used to analyze individual practice patterns. The Service Chief will utilize the data to formulate recommendations for the Executive Committee of the Medical Staff and Director to consider in the renewal of clinical privileges.

2.1.9. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.10. DEA: Contractor shall provide copy of current DEA certificate (if applicable) for Nebraska where services will be provided under this contract.

2.2. Technical Direction: The qualifications of contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Technical direction of all clinical personnel covered by this contract will be provided by the VA NWIHCS COS and/or the Chief of the Service or his/her designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request during the administration of the resultant contract.

2.3. Non-Personal Services: This contract is a non-personal health care services contract as defined in Federal Acquisition Regulation 37.101 and is as follows: “Non-personal services contract means a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.” The parties agree that the contractor, all contractor staff, agents and sub-contractors shall not be considered VA employees for any purpose.

2.3.1. Inherently Governmental Functions: Contractor and contractor staff shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.3.2. No Employee Status: The contractor shall be responsible for protecting the contractor’s staff furnishing services. To carry out this responsibility, the contractor shall provide or certify that the following are provided for all of their staff providing services under the resultant contract:

• Workers’ compensation

• Professional liability insurance

• Health examinations

• Income tax withholding, and

• FICA and Medicare tax withholding

2.3.3. Tort: The Federal Tort Claims Act does not cover contractor’s or sub-contractor’s staff. When a contractor or a member of their staff has been identified as a provider in a tort claim, the contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a contractor’s staff action or non-action is the responsibility of the contractor and/or insurance carrier.

2.3.4. Malpractice Claims: The NWIHCS Facility Director or designee will provide written notification to all licensed practitioners when a claim for medical malpractice is filed with respect to care provided by that practitioner (reference VHA Directive 2009-032). Such notification must be provided within 30 days from the date Regional Counsel notifies the facility Director that a claim for medical malpractice has been filed under the Federal Tort Claims Act (FTCA), Title 28 United States Code (U.S.C.) 1346(b), 2671-2680. The notice will provide the following information:

• Patient’s name and address, as provided on the Standard Form (SF) 95, Claim for Damage, Injury, or Death, claim form;

• Date(s) the incident giving rise to the claim occurred;

• Incident described in the claim;

• Asserted basis of malpractice liability; and

• Name and telephone number of the Regional Counsel for the facility where the event occurred.

A copy of the notice is forwarded to the appropriate Regional Counsel office.

2.4. General:

2.4.1. The Government may evaluate the quality of professional and administrative services provided but retains no control over the medical or professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with FAR 37.401(b).

2.4.2. Absences: The payment for any leave, including sick leave, holiday, or vacation time, is the responsibility of the contractor and appropriate coverage in accordance with the contract terms and conditions must be supplied by the contractor.

2.4.3. To the extent that this contract is subject to Section 952 of the Omnibus Reconciliation Act of 1980, 42 U.S.C. 1395(v)(1)(I), and the regulations promulgated hereunder, and the cost or the value or the services provided is $10,000 or more over a 12-month period, the contractor shall allow the Comptroller General and their duly authorized representatives to have access to the contractor’s contract, books, documents and records until the expiration of four years after the services are furnished under the Agreement.

2.5. Key Personnel and Emergency Substitutions:

2.5.1. For those contract personnel that require access to the VA computer system, an active Electronic Permission Access System (ePAS) account and PIV card (as applicable) are required.

2.5.2. During the first ninety (90) days of performance, the contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provided the information required by paragraph 2.5.3., below. After the initial 90-day period of the contract the contractor shall submit the information required by paragraph 2.5.3., below, to the CO at least 15 days prior to making any permanent substitutions. NOTE: Contractor will not be reimbursed for any services performed by a contractor not identified on the contract.

2.5.3. The contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.5.4. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays or more, the contractor will provide a qualified replacement for the key person identified in the contract. The substitute shall have comparable qualifications to the key person, including credentialing and privileging requirements (if applicable) to ensure that Veteran care is not delayed. Any period exceeding two weeks will require the procedure as stated in paragraph 2.5.2., above.

2.5.5. Because continuity of care is an essential part of VA NWIHCS’s medical services, the contractor is to have a contingency plan in place to be utilized if a contractor staff member leaves contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract. A copy of this contingency plan shall be submitted with the proposal and updated throughout the period of performance.

2.5.6. Contractor shall submit a listing of key personnel in the following format:

Provider Name: ___________________ Title/Rank: __________________.

Curriculum Vitae of each key personnel shall be submitted with the proposal.

3. CONTRACTOR RESPONSIBILITIES:

3.1. Services Required: Contractor shall provide Pathology and Laboratory Medicine services for VA beneficiaries. All work is to be performed at the contractor’s site.

Contractor is responsible for providing all supplies, materials, equipment and labor to perform the services.

3.2. The contractor shall provide timely and appropriate testing of patient specimens as requested by VA NWIHCS facilities.

3.3. Services shall include:

3.3.1. Transportation of clinical laboratory specimens, originating from the Omaha VA

Medical Center, Grand Island and Lincoln Community Based Outpatient Clinics (CBOCs) to the contractor’s site, contracted commercial reference laboratory or designated site. All specimens picked up from Grand Island and Lincoln CBOCs will be transported to the Omaha VA.

3.3.2. Performance of pre-analytical testing – to be labeled 100% correctly all of the time to include case number OR patient full name and full SSN or full DOB.

3.3.3. Performance of analytical testing.

3.3.4. Reporting of analytical test results.

3.3.5. Histology:

3.3.5.1. Slides will be cut and labeled with appropriate identification labels.

The slides must be returned by 9:00 a.m. daily for assessment and reporting and for permanent storage. Blocks will be returned to the VA (for permanent storage) on a monthly basis.

3.3.5.2. Contractor to provide the VA Pathologists and residents with an accurate, reliable and seamless method to process requests to order special stains, extra cuts, etc. Ordering additional studies on tissue blocks will include, but not be limited to:

• Recuts

• Levels

• Special Stains

• Immunohistochemical Stains

• Send Out to Third Party Reference Laboratory for Specialty

Studies

• Delivery of tissue blocks to VA for VA required activities [There may be a request for legal purposes] Routine cases, that require additional studies, i.e., cuts, stains, etc., will be turned around in the next business day of the request.

3.3.5.3 Listing of supplies to be furnished by VA and contractor (reference table in paragraph 1.1.5.).

3.3.6. Cytology:

3.3.6.1. VA will send specimen and requisition with information needed to order in contractor’s LIS with a routine courier.

3.3.6.2. Contractor staff will accession cases in contractor’s LIS.

3.3.6.3. Contractor cytotechnologists will transcribe into contractor’s LIS. The contractor will perform both the technical and professional components (to be billed using the applicable component rates).

3.3.7. Internal Consults and Second Signature Consults as requested (Attachments 8 and 9).

3.3.8. Global Case Review:

3.3.8.1. If there are global cases, the contractor must review 10% of all global cases monthly per accrediting agency guidelines.

3.3.8.2. The contractor shall prepare a monthly report showing the results of

3.3.8.1 and submit it to the COR no later than the 20th day of the following month.

3.3.8.3. Any discrepant results must be communicated by telephone or in person within one (1) working day to a VA Pathologist and be included in the monthly report.

3.3.9. Autopsies:

3.3.9.1. The provisional anatomic diagnoses must be provided to the VA within two (2) working days via encrypted e-mail and secured fax.

3.3.9.2. The completed post-mortem exam, with final copy of succeeding pages, must be submitted to the VA within 30 working days unless exceptions for special studies are established by the medical staff.

3.3.10. Colon and Rectum Resection:

3.3.10.1. At least 12 regional lymph nodes must be removed and pathologically examined for resected colon cancer.

3.3.10.2. If fewer than 12 lymph nodes are found, re-examine the specimen for additional lymph nodes, with or without visual enhancement techniques, and document in the patient’s final report.

3.3.10.3 Any deviation from CAP Protocols must be documented in patient’s final report.

3.4. Services – Certified Laboratory(s):

3.4.1. In the event a CPT code cannot be performed at the contractor’s facility, tests can be referred out to a certified laboratory facility. Contractor will provide all supplies necessary to transport specimens including, but not limited to: shipping containers, tapes and labels. Tests that are sent out will be reimbursed at contractor’s cost. An administration fee will not be charged. A copy of the current fee pricing and/or invoice for send-out/referred testing fees will be submitted with invoice for documentation.

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

3.4.3. Copies of all relevant permits/licenses and certification 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.

The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor. The contractor must notify the Contracting Officer of the expiration or the revocation of any of these licensures.

3.5. Test Results:

3.5.1. Non-Emergent/Routine Cases:

3.5.1.1. Non-Emergent/Routine Surgical Cases: Test results shall be received at the Omaha VA within 3 working days of specimen receipt and within 5 working days of specimen receipt for complicated cases.

3.5.1.2. Non-Emergent/Routine Cytology Cases: Cytopathology test reports of Gynecology specimens are to be completed within 14 working days of receipt. Test reports for non-Gynecology specimens are to be completed within 5 working days.

3.5.2. Emergent (STAT) Specimen Processing - Omaha VA Only: Contractor shall pick-up specimens and provide results within 2 hours of being notified. Results will be communicated via telephone call (CP results will be called to the VA Main Laboratory and AP results will be called to the on-call VA staff pathologist) with fax to immediately follow. Failure to meet this requirement could result in review of contract compliance.

3.5.3. Each test result shall, at a minimum, include the following information. NOTE:

There will be no charge to the VA for any retesting due to contractor’s error.

3.5.3.1. Patient’s name (first and last), full SSN and/or full Date of Birth

(DOB) or identification number (i.e., case number)

3.5.3.2. Physician’s name (if supplied)

3.5.3.3. VA NWIHCS…