36C24824Q0603.pdf

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Amendment 0001 - Off-site Cancer Registry Services Federal contract opportunity
Solicitation number
36C24824Q0603
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 8

About this file

This solicitation requests offers for off-site cancer registry services. The Department of Veterans Affairs, VISN 08, Malcom Randall VA Medical Center requires catch-up and maintenance of an efficient and accurate cancer registry database in accordance with Commission on Cancer standards and VA requirements. Services shall be provided virtually and off-site by certified tumor registrars or oncology data specialists with a minimum of three years experience for a base period of one year plus four one-year options. The single award contract will be set aside for service-disabled veteran-owned small businesses. Quotes are due by March 11, 2024 and shall be submitted electronically to the point of contact provided.

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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. UEI: EFT:

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

36C24824Q0603 02-28-2024

Raimundo Rivera 813-796-3458 03-18-2024

2:00PM EDT

36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525

Tampa FL 33637

X 100

X

518210

$40 Million

N/A

Department of Veterans Affairs (VA)

Malcom Randall Veterans Hospital

1601 SW Archer Road

Gainesville FL 32608

36C248

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy

Tampa FL 33637

Financial Services Center

P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

The contractor shall provide off-site Cancer Registry

Services to include Certified Tumor Registrars (CTRs)/

Certified Oncology Data Specialists (ODS) for the Malcom

Randall VAMC, Gainesville, FL. Services shall be provided in accordance with (IAW) the Performance Work

Statement (PWS) and terms and conditions listed therein.

The period of performance (POP) is for base year, plus (+) four (4), one (1) year options. Reference pages six (6) through eight (8) for the Schedule of Services. Reference pages nine (9) through 38 for the Performance Work Statement (PWS).

This is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract type and task orders will be issued on a as needed basis.

Direct all questions for the Request for Quote (RFQ) and related documents to Raimundo Rivera, Contracting Officer at raimundo.rivera@va.gov by March 11, 2024.

$0.00

To be determined (TBD)

X 1

Raimundo Rivera

36C24824Q0603

Table of Contents

SECTION A

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 SCHEDULE OF SERVICES

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 2023)

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (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 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...48

C.8 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.9 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.10 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.11 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.12 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING —

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.13 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.14 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.15 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

C.16 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..67

C.17 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.18 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEC 2023)

SECTION D – CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D-1 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

D-2 ORGANIZATIONAL CONFLICT OF INTEREST

D-3 CONTRACTOR CERTIFICATION OF IMMIGRATION AND NATIONALITY ACT ..77

D-4 CONTRACTOR RULES OF BEHAVIOR

D-5 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING-CERTIFICATE OF

COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

D-6 VA INFORMATION SECURITY AND INFORMATION SYSTEM

SECURITY/PRIVACY

D-7 PAST PERFORMANCE QUESTIONNAIRE

D-8 WAGE DETERMINATION 2015-4537 REVISION 21 OF 12-26-2023

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020) .89

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(SEP 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.10 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.11 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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: _____________________________________________

Representative Name:

Title:

Address:

Telephone:

Facsimile:

E-mail:

Federal Taxpayer Identification Number:

Dun and Bradstreet Number:

SAM Unique Entity Identifier (UEI)

b. GOVERNMENT: Raimundo Rivera, Contracting Officer 36C248

Network Contracting Office 8 (NCO 8) Email: Raimundo.rivera@va.gov Phone: (813) 796-3458

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. Invoicing shall be in accordance with the requirements of The Department of

Veterans Affairs (VA) Financial Services Center (VAFSC). The latest 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 http://www.fsc.va.gov/einvoice.asp.

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

6. Post Award Orientation: The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by VA Acquisition Manual, Part M842.502-70.

7. Mandatory Written Disclosures: Mandatory written disclosures required by FAR clause

52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

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

AMENDMENT NO DATE

B.2 SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide services necessary to perform Cancer

Registry Services to eligible beneficiaries of the Department of Veterans Affairs (VA), Malcom

Randall Medical Center (VAMC), North Florida/South Georgia (NF/SG) Veterans Healthcare

System (hereinafter referred to as NF/SG VHS). All services shall be performed virtually off-site at the Contractor’s facility. The Contractor shall provide professional and technical services to include materials, supplies, equipment, and qualified supervision specified herein.

Place of Performance: Services shall be provided virtual and off-site at the Contractor’s facility.

Services shall be provided for the Malcom Randall VAMC located at 1601 SW Archer Road, Gainesville, Florida 32608.

Period of Performance: One (1) base year, and four (4) - one (1) year options to be exercised at the sole discretion of the Government based on the continual need for services.

Minimum and Maximum Quantity: This requirement includes a guaranteed minimum of

$2,500.00 of services for the base year of the contract. The maximum amount to be ordered for this contract for the base, and all option periods, if exercised by the Government, is

$1,300,000.00. If the maximum aggregate amount of $1,300,000.00 is reached prior to the end date of the final period of performance, no further task orders will be issued on the contract.

Task Order/Ordering Procedures: A task order will be issued at the start of each performance period by the Contracting Officer. Task Orders will be obligated with a Not to Exceed (NTE) amount and contractor shall not exceed those quantities or dollar threshold without the express or written consent of the Contracting Officer. Adjustment made without approval will be considered an Unauthorized Commitment; violation under Federal Acquisition Regulation, FAR

1.602-3. Task Order will contain date of order, order number, line-item number (LIN), description, quantity, unite, performance schedule, and accounting and appropriations data.

Estimated Quantities: The quantities listed in the Price Schedule below are annual estimates only and are not to be considered a minimum or maximum. The Government is not obligated to purchase any specified number of services under this contract but will be obligated to make payment for all services requested and received in the quantities and the quality requested. The

Government does not guarantee or imply that any fixed number of units for services will be placed under the resultant contract.

Pricing Instructions:

Quoter must fill out the cells in the columns in the Price Schedule for each contract Line-Item

Number (LIN). The Quoter is instructed to complete the unit price, total estimated price, and total estimated annual price based on the maximum estimated quantities of units.

Throughout the life of the contract the VA will pay the awarded fixed pricing effective at the time the service is provided by the Contractor.

This basis of the contractor’s proposed fixed pricing will be used by the Government for future pricing of additional codes/procedures and for reimbursement under the contract. The basis of estimate used for your fixed price, i.e., the way that your price is calculated, shall remain the same throughout the life of the contract and may be validated by post award audits.

The Contractor shall complete the price schedule for the performance location proposed. The

Contractor shall base pricing on the application of fixed Government pricing. Contractor shall submit pricing for each Line-Item Number (LIN) shown on solicitation Price Schedule. No LINs shall be left blank. Only Microsoft Word or Adobe PDF constructed files are acceptable.

PRICE SCHEDULE

BASE YEAR period of performance: 05-01-2024 to 04-30-2025

ITEM

NUMBER

DESCRIPTION OF

SERVICES

ESTIMATED

QUANTITY

UNIT

PRICE

TOTAL

Cancer Registry Case Abstracts

EA

Cancer Registry Follow Up

Consultant

HR

Total for Base Year $_________________

OPTION YEAR ONE (1) period of performance: 05-01-2025 to 04-30-2026

TOTAL

Finding

Total for Option Year 1 $________________

OPTION YEAR TWO (2) period of performance: 05-01-2026 to 04-30-2027

TOTAL

Total for Option Year 2 $________________

OPTION YEAR THREE (3) period of performance: 05-01-2027 to 04-30-2028

TOTAL

Total for Option Year 3 $________________

OPTION YEAR FOUR (4) period of performance: 05-01-2028 to 04-30-2029

TOTAL

Total for Option Year 4 $________________

Total amount (Base plus (+) all options): $___________________

B.3 PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL:

1.1. Services Provided: The Contractor shall provide labor, personnel, equipment, supplies, materials, supervision, and other related services necessary to provide Cancer Registry services in accordance with VA and all applicable national standards and in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the NF/SG VHS.

1.2. The goal of this procurement is to catch up the backlog and establish a safe and uniform process for maintaining an efficient & accurate cancer registry database in accordance with 100% of the current Commission on Cancer (COC) standards, VHA cancer registry requirements, and State requirements (where applicable).

1.3. Interested vendors shall have at least three (3) years of experience in providing cancer registry services and recent experience with the COC standards.

1.4. No guarantees are made as to the estimated work or volumes, or the quantities. The estimate information provided in the scope of work is based on historical data and current backlog. The estimates and actual work are subject to change by the Government. Quoters shall work remotely outside of the VA, and will require VA Access, personally owned computers, and PIV Cards with Logical Access.

1.5. Place of Performance: Contractor shall furnish services virtually for the Malcom Randall VAMC and the NF/SG VHS located at 1601 SW Archer Rd, Gainesville, FL 32608.

1.6. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority; Federal Acquisition Regulations (FAR) Part 12 – Acquisition of Commercial Items, and FAR Part 13 – Simplified Acquisition Procedures.

1.7. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.7.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.7.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

1.4.11. VHA Directive 1907.01: VHA Health Information Management and Health Records https://www.va.gov/vapubs/ https://www.va.gov/vhapublications/index.cfm https://www.va.gov/vhapublications/index.cfm

1.4.12. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

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

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.8. Acronyms/Definitions: Terms used in this contract 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. ACOS: American College of Surgeons - is a scientific and educational association of surgeons that was founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice.

1.5.2. CCNE: Commission on Collegiate Nursing Education:

www.aacn.nche.edu/accreditation

1.5.3. CDC: Centers for Disease Control and Prevention

1.5.4. CEU: Certified Education Unit

1.5.5. CME: Continuing Medical Education

1.5.6. CMS: Centers for Medicare and Medicaid Services

1.5.7. COC: Commission on Cancer - is a consortium of professional organizations dedicated to improving survival and quality of life for cancer patients through standard setting, which promotes cancer prevention, research, education, and monitoring of comprehensive quality care.

1.5.8. 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.

1.5.9. 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.

1.5.10. COS: Chief of Staff

1.5.11. CPARS: Contractor Performance Assessment Reporting System

1.5.12. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.5.13. CTR: Certified Tumor Registrar credential demonstrates a requisite knowledge and professional competence needed within the cancer registry. It is nationally recognized in the recruitment and retention of registry personnel. Also known as a Certified Oncology Data Specialist (ODS).

1.5.14. EHR: Electronic Health Record - electronic health record system used by the VA.

1.5.15. FTE: Full Time Equivalent. VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.16. HIPAA: Health Insurance Portability and Accountability Act

1.5.17. HR: Human Resources

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.aacn.nche.edu/accreditation

1.5.18. ISO: Information Security Officer

1.5.19. NAACCR: North American Association of Central Cancer Registries - is a professional organization that develops and promotes uniform data standards for cancer registration; provides education and training; certifies population-based registries; aggregates and publishes data from central cancer registries; and promotes the use of cancer surveillance data and systems for cancer control and epidemiologic research, public health programs, and patient care to reduce the burden of cancer in North America: Home (naaccr.org)

1.5.20. NCRA: National Cancer Registrars Association – A professional organization that represents cancer registry professionals and Certified Tumor Registrars. The NCRA supports cancer professionals through innovations in education, advocacy, credentialing, and strategic partnerships. NCRA provides training through various mediums including annual conferences, workshops, publications, and their continuing education credit program: National Cancer Registrars Association > Home (ncra-usa.org)

1.5.21. NOP: National Oncology Program

1.5.22. ODS: Certified Oncology Data Specialist – also known as a Certified Cancer

Tumor Registrar (CTR).

1.5.23. POP: Period of Performance

1.5.24. PWS: Performance Work Statement

1.5.25. QA/QI: Quality Assurance/Quality Improvement

1.5.26. QASP: Quality Assurance Surveillance Plan

1.5.27. QM/PI: Quality Management/Performance Improvement

1.5.28. VetPro: is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.29. VAMC: Veterans Affairs Medical Center

1.5.30. VHA: Veterans’ Health Administration

1.5.31. VISN: Veterans Integrated Services Network

1.5.32. VISTA: Veterans Information Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Education – CTR/ODS Certification: The contractor shall show proof that those providing abstracting services are Certified Tumor Registrars (CTR) or Oncology Data Specialist (ODS) through the National Cancer Registrars Association (NCRA).

Contractor personnel functioning under this contract shall be certified by the National Cancer Registrars Association. The Contractor shall verify its personnel’s current certification status with the National Cancer Registrars Association and shall provide evidence of certification with their quote submission. Ongoing cancer related education enhances knowledge and skills. All Contractor Cancer Registry staff who performs case abstracting must:

https://www.naaccr.org/ https://www.ncra-usa.org/ https://www.ncra-usa.org/

2.1.1. Hold a current Certified Tumor Registrar (CTR)/Oncology Data Specialist (ODS) credential. The CTR/ODS credential is granted through the National Cancer Registrars Association, which provides details on eligibility, testing, and re-credentialing.

2.1.2. Non-Credentialed CTR/ODS personnel may perform case finding and follow-up but cannot perform any abstracting on analytic cases unless they are performed under the supervision of a CTR/ODS per the documented plan.

2.1.3. High-quality Cancer Registry data is essential to accurately access treatment outcomes and patient survival. Successful operation of the Cancer Registry requires credentialed staff that is trained and knowledgeable in all aspects of oncology data collection and case abstracting. Abstracting is defined as coding and entering patient- and disease specific information into the Cancer Registry data base. CTR/ODS apply knowledge obtained from formal education and work experience to correctly interpret and code cancer diagnosis and stage treatment and outcomes information for each case that is seen at the VAMC that meets COC reporting requirements. The case abstracting responsibilities of the CTR/ODS are documented by the Contractor. In addition, the Contractor shall provide documentation upon request and annually that all members of their Cancer Registry staff are maintaining their CTR/ODS status this requires 20 CEUs every 2 years as in accordance with industry standards.

2.1.4. Technical Proficiency: Contractor’s personnel 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 shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for Contractor’s personnel shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR validation of current CMEs as required or requested by the VAMC. Contract personnel must be certified by national association and shall continue to meet the minimum standards for CME to remain current. Contractor shall provide the most current credential cycle validation certificate annually or when requested.

2.1.6. Training (VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s personnel as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Mandatory Training Frequency Annual Hours

DVA-002 Privacy and HIPPA Once A Year 1

DVA-003 Privacy and Information Security Awareness and Rules of Behavior

Once A Year 1

2.1.6.1. Computerized Patient Record System (CPRS) in VISTA. VA will provide contractor with electronic access to CPRS for use by the Certified Tumor Registrars. Contractor employees are responsible to access the system a minimum of once every ninety (90) days. Failure to access VA system at least once every ninety (90) days will result in the contractor’s employees being locked out of the VA system. The VA will provide Contractor with remote access to the VA Network and Computerized Patient Record System (CPRS) in VISTA. It is expected that electronic access will be done monthly by Contractor’s abstracting personnel.

2.1.6.2. Vista-Oncotrax System Applicable system software functionality training will be provided by VISN Cancer Registry staff as needed. Prior to commencement of work the Contractor and Contractor staff shall have a working knowledge and competencies required for effective utilization of the VA abstracting software programs and computer hardware. Work will begin within 30-60 days from date of contract award.

2.1.7. Conflict of Interest: The Contractor and all Contractor’s personnel are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of quote and during the entirety of contract performance. At the time of quote, 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 of the solicitation document.

2.1.8. Citizenship related Requirements:

2.1.8.1. 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;

2.1.8.2. 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.

2.1.8.3. 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 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.

2.1.8.4. 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.

2.1.8.5. The Contractor agrees to obtain a similar certification from its subcontractors.

The certification shall be made as part of the quoter’s response to the RFP using the subject attachment in Section D of the solicitation document.

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

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

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

2.2. Clinical/Professional Performance: 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 Directive 1100.20 and VHA Directive

1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.3. Non- Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s personnel shall not be considered VA employees for any purpose.

2.4. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to http://oig.hhs.gov/exclusions/index.asp property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.5. Prohibition against Self-Referral: Contractor’s personnel are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6. Inherent Government Functions: Contractor and Contractor’s personnel 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 (outside a clinical context), 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.

2.7. No Employee status: The Contractor shall be responsible for protecting Contractor’s personnel furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract provider(s). When a Contractor or contract provider (s)has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract physician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

3. VA HOURS OF OPERATION/SCHEDULING

3.1. VA Business Hours: VAMC Cancer Registry Service is conducted Monday – Friday from 8:00 am – 4:30 pm Eastern Standard Time, however as the contractor is reimbursed by deliverables received, the Contractor is not obligated to only work these hours.

3.2. Contractor shall be available to the VAMC for assignments as requested by VAMC Cancer Program Team.

3.3. Contractor is paid per deliverables received and validated as meeting requirements;

described in Section 4.4.

3.4. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

• New Year’s Day

• President’s Day

• Martin Luther King’s Birthday

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES

4.1. Clinical Personnel Required: The Contractor shall provide contractor CTR/ODS’s who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Contractor shall be responsible for providing onboarding documentation, Information Security, Rules of Behavior, Privacy Training, and completing the VAMC VPN requests for computer access for each CTR/ODS who will be providing work under the contract.

4.2. All contractors, subcontractors, and third-party servicers and associates working with VA information must use the VA email address issued (@va.gov) and encrypted when communicating electronically. The use of personal email address or company email address by contracting personal is prohibited.

4.3. All CTR/ODS's must comply with NCRA's 20 hrs. of continuing education (CE) every two (2) years requirement to maintain their credential in good standing. All CTR/ODS's are required to complete the annual VA training for Privacy and Security and HIPAA.

4.4. Certification/ Logs of monthly work completion: The Contractor shall prepare and submit to the COR or National Oncology Program (NOP) representative a certificate of work completion with monthly invoices. The certificate shall, as a minimum, contain the following:

4.4.1. Accession/Sequence Number of Cases/works completed

4.4.2. Name of contract staff completing the case/work

4.4.3. Date case/work was completed

4.4.4. Comments from contractor’s staff as needed

4.5. Management and Supervision:

4.5.1. The Contractor shall be responsible for supervising the daily services provided under this contract by the Contractor’s personnel.

4.5.2. The Contractor shall have written policies and procedures regarding personnel credentials and privileging.

4.5.3. The VAMC will provide to the Contractor policies, procedures, and processes necessary to allow cooperative functioning between the agency and VAMC. Updates and refreshers will be provided to the Contractor upon request and when policy procedures or process changes.

4.5.4. The Contractor shall complete background investigations to insure that employees do not have a record of criminal offenses or substantiated incidents of patient abuse; and, if required to perform their duties, employees are properly licensed and insured to operate motor vehicles.

4.6. MEDICAL RECORDS

4.6.1. Authorities: Contractor’s personnel providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R.

Parts 160, 162, and 164 (HIPAA).

4.6.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA Privacy Act system of records entitled ‘Patient Medical Records-VA’ (24VA10A7).

Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.4.4.

4.4.3.

4.6.3. Disclosure: Contractor’s personnel may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.6.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Directive 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the facility.

4.6.5. Release of Information: The VA shall maintain control of releasing any copies of patient health information or health records and will follow policies and standards as defined, but not limited to Privacy Act requirements. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

4.6.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.7. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY

IMPROVEMENT (QI)

4.7.1. Quality Management/Quality Assurance Surveillance: Contractor personnel shall be subject to Quality Management measures, such as timely completion of reducing current backlog, follow-ups, case findings, and consultation per facility https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 direction. Methods of Surveillance: monthly tracker/invoice/completion list and quarterly performance evaluation. Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods, frequency, and results of surveillance conducted. All VAMC quality audits revealing discrepancies shall be corrected within 7 working days.

4.7.1.1. Currently, Medicine Service requires the services of a Cancer Registry Service to perform case abstracting to assist in the reduction of caseload backlog, follow-ups, case findings, and consultation. These abstracts organize, summarize, and categorize the crucial information in a patient's medical records for each reportable tumor. For the Base Year Period of Performance, we expect the CTR/ODS(s) to abstract approximately 125 cases per month, with a reduction in backlog to meet or exceed 1,500 cases. Each contracted Option Year after Base Year, we expect the CTR/ODS(s) to abstract approximately 200 cases per month, with a reduction in backlog of to meet or exceed 2,500 cases per contract year. The CTR/ODS will work remotely with computer access to the necessary software/applications including CPRS. The facility’s average caseload is approximately 1,450 cases annually. The contractor shall abstract cases in sequential calendar year order at the discretion of the COR, Cancer Program, or NOP.

4.7.1.1.1. Case Abstracting Performance: For the Base Year Period of Performance, we expect the CTR/ODS(s) to abstract approximately 125 cases per month, with a reduction in backlog to meet or exceed 1,500 cases per contract base year. Contracted Option Years 1-3 after Base Year, we expect the CTR/ODS(s) to abstract approximately 200 cases per month, with a reduction in backlog to meet or exceed 2,500 cases per contract year. Contracted Option Year 4, we expect the CTR/ODS(s) to abstract approximately 125 cases per month, to meet or exceed 1,500 cases per contract base year; this will meet the facility’s average caseload is approximately 1,450 cases annually.

4.7.1.1.2. Case Follow-Ups Performance: The contractor shall provide follow-up to provide information on disease status to National standards at the discretion of the COR, Cancer Program, or NOP for the Base Year Period and Options Years 1-4 of Performance.

4.7.1.1.3. Case Findings Performance: The contractor shall provide case findings for comprehensive incidence reporting that meets national standard;

work assigned at the discretion of the COR, Cancer Program, or NOP.

4.7.1.1.4. Consultation: This will be on an as needed basis during contracted period of performance and as determined by COR or VA POC. We expect the CTR/ODS(s) to provide consultation as needed with approximately 120 hours per contract year.

4.7.2. Task and Deliverables: The Contractor shall provide all necessary staffing and resources needed to properly maintain the NF/SG VAHCS Cancer Registry database services in accordance with 100% of the current American College of Surgeons Commission on Cancer Registry standards and Veterans Health Administration (VHA) Cancer Registry requirements. VA reportable list will be shared with the receiving contractor after award. The Contractor shall have current experience managing a Cancer Registry program within the last two years and have recent experience with the American College of Surgeons (ACOS)

Commission on Cancer (COC) Standards. The duties and responsibilities of the Contractor shall include but are not limited to:

4.7.2.1. Case Findings – This will be performed on an as needed basis during Option Years, but not to be performed during Base Year period of performance. This task may be performed by a non-credentialed CTR/ODS staff, but under the supervision of a CTR/ODS per the ACOS/COC guidelines. The Contractor shall electronically screen and accept all cases into the Cancer Registry database and shall flag all cases as suspense with demographics and ensure cases are primary site coded. The Contractor shall review and validate all reportable diagnoses from all available data sources into the Cancer Registry database and shall accession with at least the accurate minimum data set within 30 days of diagnosis. When assigned, the Contractor shall be responsible for monthly review of disease indices, pathology reports, radiology reports, outpatient oncology treatment encounters, and other computerized methods to identify reportable cancer patient. The Contractor shall be responsible for reviewing and interpreting information from patient records regarding the diagnosis and treatment of an estimated 1,450 new VAMC cancer patients annually using the approved Veterans Administration (VA) cancer registry database software program. The Contractor shall review all new cases for inclusion in the Oncotrax database in compliance with the industry standards of the North American Association of Central Cancer Registries (NAACCR), National Cancer Institute Surveillance, Epidemiology and End Results Program (SEER), World Health Organization International Classification of Diseases for Oncology (ICDC), American Joint Commission on Cancer (AJCC) Staging Manual Criteria, VA Central Cancer Registry (VACCR) Reportable List, American College of Surgeons/Commission on Cancer (ACOS/CC) and the VAMC Cancer Registry criteria. The Contractor shall return a monthly list of cases accessioned along with the Contractor's monthly invoice to the COR, Cancer Program, and NOP.

4.7.2.2. Case Abstracting and Coding – This task is required to be performed by a credentialed CTR/ODS. Abstracting is defined as entering all required patient and disease specific information that meet VA and national standards for content and quality using the approved VA cancer registry database software identified within this PWS. The Contractor shall provide complete, accurate quality abstraction services and shall ensure that all submitted data clears software data quality edits specific to diagnosis year in the volume and time per this PWS. The Contractor shall abstract oncology cases with a minimum 90% accuracy established benchmarks and shall ensure that all Commission on Cancer requirements/standards are met. Contractor is responsible to transcribe and interpret information from patient records regarding treatment provided to new cancer patients annually using the approved Veterans Administration (VA) abstracting software program (currently the Vista- Oncotrax). The Contractor shall review and abstract the cancer patient’s medical record on an ongoing basis in compliance with the industry standards of the North American Association of Central Cancer Registries (NAACCR), National Cancer Institute Surveillance, Epidemiology and End Results Program (SEER), World Health Organization International Classification of Diseases for Oncology (ICDC), American Joint Commission on Cancer (AJCC) Staging Manual Criteria, VA Central Cancer Registry (VACCR) Reportable List, American College of Surgeons/Commission on Cancer (ACOS/CoC) and the VAMC Cancer Registry criteria. The contractor will be a credentialed CTR/ODS, and produce and provide proof of current credential status, to provide abstracting services. The Contractor shall abstract cases within 4-6 months of the cancer diagnosis. The Contractor shall return a monthly list of case abstracts completed along with the Contractor's monthly invoice to the COR, Cancer Program, and NOP.

4.7.2.3. Cancer Registry Follow Up – This task may be performed by a non-credentialed CTR/ODS staff, but under the supervision of a credentialed CTR/ODS per the ACOS/COC guidelines. Follow up activities for disease surveillance will only be conducted at the discretion and direction of the facility Cancer Program or professional designee. Long-term follow-up is essential to evaluate outcomes of cancer care.

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