36C25022Q0021.docx

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R702--Cancer Registry Services Battle Creek - VOSB Set-Aside
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36C25022Q0021
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36C25022Q0021

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25022Q0021 12-15-2021 Leitch, Sally L.

317-988-1538 01-03-2022 14:00

EST

36C250 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 1100 Indianapolis

IN

46240 X X 518210 $35 Million N/A X Department of Veterans Affairs Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek

MI

49037 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 1100 Indianapolis

IN

46240

See website at:

https://www.fsc.va.gov/einvoice.asp for instructions & for invoicing website at:

https://www.tungsten-network.com/ customer-campaigns/veteransaffairs

See CONTINUATION Page The Battle Creek VA Medical Center requires a contractor to provide cancer registrar services in accordance with the Statement of Work (SOW).

All questions related to this solicitation shall be submitted in writing by the 5th calander day after the solicitation is posted.

Quoters shall provide ALL information listed in Section E Instructions for Submission of Quote for their quote package to be determined responsive.

This requirement is being procured under FAR Part 16 as a Indefinite Delivery Indefinite Quantity (IDIQ) contract.

This is a 100% VOSB set-aside.

All questions regarding this solicitation shall be submitted in writing by the 5th day after issuance of the solicitation Phone calls shall not be accepted.

$150,000.00

NTE

See CONTINUATION Page X X X Leitch, Sally L.

Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 ELECTRONIC INVOICE SUBMISSION AND INVOICING6
B.3 PRICE/COST SCHEDULE INFORMATION7
B.4 PRICE/COST SCHEDULE9
ITEM INFORMATION9
B.5 STATEMENT OF WORK14
B.6 IT CONTRACT SECURITY28
SECTION C - CONTRACT CLAUSES39
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)39
C.2 52.216-18 ORDERING (AUG 2020)45
C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)45
C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)46
C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)46
C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)46
C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)47
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)47
C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)48
C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)49
C.11 VAAR 852.219-77 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (SEP 2021) (DEVIATION)50
C.12 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)52
C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)52
C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (SEP 2021)52
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS61
BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION, Battle Creek VA Medical Center, AND61
WAGE DETERMINATION INFORMATION66
SECTION E - SOLICITATION PROVISIONS68
E.1 52.212-1 INSTRUCTIONS TO QUOTERS—COMMERCIAL ITEMS68
E.2 INSTRUCTIONS TO QUOTERS – EVALUATION OF QUOTES71
E.3 INSTRUCTIONS FOR SUBMISSION OF QUOTE72
E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)74
E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)77
E.6 52.212-2 EVALUATION—SIMPLIFIED ACQUISITION PROCEDURES77
E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)79

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. Contractor:

Contractor Name

Contractor Address

Contractor Main Phone

Contractor Fax

Contractor Primary POC

Contractor Primary POC Title

Contractor Primary POC Phone

Contractor Primary POC Email

Contractor Primary POC

Contractor Primary POC Title

Contractor Primary POC Phone

Contractor Primary POC Email

Duns Number

SAM ID Number

Tax ID Number

Business Size

b. Government:

Contracting POC
Sally L. Leitch, Contracting Officer, NCO 10, 36C250
Contracting Address
Department of Veterans Affairs

Veterans’ Health Administration Network Contracting Office (NCO) 10 8888 Keystone Crossing, Suite 1100 Indianapolis, IN 46240

Contracting POC Phone
317-988-1538
Contracting POC Email
Sally.Leitch@va.gov
Contracting Officer Representative (COR) POC
Michele Silvers, Chief HAS
COR Address
Department of Veterans Affairs

Veterans’ Health Administration Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek, MI 49037

COR POC Phone
269-966-5600 x35431
COR POC Email
Michele.Silvers@va.gov

2. Contractor Remittance Address: All payments by the Government to the contractor will be made in accordance with:

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

3. Invoices: Invoices shall be submitted in arrears:

c. Other [x] Monthly to: http://www.tungsten-etwork.com/us/en/

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.

Tungsten Network: http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/

5. Secure Fax: All faxes regarding this contract shall contain the following on the coversheet:

This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, 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. Service Contract Act: The Department of Labor’s Service Contract Act applies to this procurement.

a. For purposes of this solicitation, as it is unknown at the time of this solicitation where the contractor will perform these services, the wage determination incorporated is for the Battle Creek VA Medical Center, Calhoun County, Michigan.

b. Contractor shall list the following information as part of their quote package so that the correct wage determination can be incorporated at time of award:

State of Services
County(ies) of Service

7. Quote Submission: Quoters shall follow the submission instructions provided in Section E of this solicitation. Quoters that do not submit a complete quote package containing all required items as required in the Statement of Work and in Section E shall not be considered for award.

8. Late Quotes: Shall not be accepted.

9. Questions: All questions shall be submitted via email no later than the 5th calendar day at Noon, Eastern Time, after the issuance of the of the solicitation to Sally.Leitch@va.gov.

10. Acknowledgement of Amendments: Quoter shall acknowledge all amendments by completing the table below:

Amendment Number
Date of Acknowledgement
Name & Tile
Signature

B.2 ELECTRONIC INVOICE SUBMISSION AND INVOICING

VENDOR ELECTRONIC INVOICE SUBMISSION REQUIREMENTS AND METHODS

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

1. VA’s Electronic Invoice Presentment and Payment System – the FSC uses a third-party contractor, Tungsten Network (referred to OB10), to transition vendors from paper to electronic invoice submission. Please go to website: http://www.tungsten-network.com/customer-campaigns/veteransaffairs to enroll in the program and begin submitting the electronic invoices, free of charge.

1. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI website is: http://www.x12.org

1. Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

2. Tungsten e-Invoice Setup Information: 1-877-489-6135

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

2. FSC e-Invoice Contact Information: 1-877-353-9791

2. FSC e-Invoice email: vafsccshd@va.gov

BILLING AND INVOICING

1. In accordance with this contract, all services shall be billed in arrears on a monthly basis.

2. Contractor shall only bill for services rendered and for line items delivered.

3. A proper invoice that is submitted for payment, shall be accepted, and certified for payment if:

i. Monthly invoice is submitted in arrears, no later than the 20th business day of the following month that services were rendered.

ii. Invoice contains in addition to the information required for submission of a ‘proper’ invoice in accordance with FAR 52.212-4(g) the following information:

a. Name and Address of the Contractor

b. Invoice Date and Invoice Number

c. Contract Number

d. Contract Order Number

e. Purchase Order Number

f. Date Range of Services Provided

g. Description of Services Provided

h. Line/Sub-Line Item number(s) of services provided

i. Quantity of each Line/Sub-Line Item

j. Unit Rate for each Line/Sub-Line Item

k. Total Cost for each Line/Sub-Line Item

l. Total Invoice Cost

4. The Certifying Official will confirm the information in the submitted invoice to the contract and invoice to ensure it is correct and valid.

i. If the invoice submitted is not a proper invoice, the certifying official shall refuse the invoice with a detailed statement as to why the invoice was refused.

ii. Contractor shall make corrections and resubmit using a separate invoice number, notating the invoice number it is replacing.

B.3 PRICE/COST SCHEDULE INFORMATION

Contractor shall provide all necessary labor, management, equipment, and transportation to provide cancer registry services as stated in the Statement of Work.

Evaluation of Options - For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will therefore assume that the addition of price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all quotes relative to each other and will not affect the ranking of quotes based on price, unless after reviewing the quotes, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8.

FAR Clause 52.217-8 Option to Extend Services: If FAR 52.217-8 is utilized at the end of the contract, prices of any possible extension or extensions will be the awarded pricing for the most currently awarded period pricing. The Government is not obligated to exercise any of the option years under FAR 52.217-9.

Estimated Quantities: The Government has provided their best estimate as to the number of items/units that will be required over the base year and all four one-year options. The need for services may change due to needs of the medical center. There is no guarantee that the exact number items/units listed in the price schedule will be always needed.

Minimum Guarantee: The minimum guarantee for this contract is $500.00 over the life of the contract and all options.

Maximum Contract Value: The maximum value of this contract shall be no more than $150,000.00 over the life of the contract, all options, and modifications.

Breakdown of Services and Pricing can be found in Section D.

Billing: While the contract is estimated, the contractor shall bill once monthly in arrears. Contractor shall bill by Line and Sub-line-Item numbers equaling the total number for the month. Invoices submitted through Tungsten shall include all requirements of the Billing and Invoicing section of this solicitation and FAR 52.212-4(g) to have payments certified.

For Example: October 2020 invoice will be submitted in November of 2020 listing all the required information as listed in the SOW and 52.212-4(g):

· Line Item 0001 Monthly Total of XXXX.

· Sub-Line Item 0001AA Backlog - Findings at @ $XX = $XX

· Sub-Line Item 0001Ae Maintenance - Abstract at @ $X= $XX

Estimated Period of Performance Totals

Base Year

Option Year 1

Option Year 2

Option Year 3

Option Year 4

Total Estimated Contract Value

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT

0.00

__________________
__________________

Cancer Registry Services In Accordance with the Statement of Work Contract Period: Base POP Begin: 02-01-2022 POP End: 01-31-2023 PRINCIPAL NAICS CODE: 518210 - Data Processing, Hosting, and Related Services PRODUCT/SERVICE CODE: R702 - Support - Management: Data Collection

0001AA

3,037.00
CS
__________________
__________________

Backlog - Case Finding Contract Period: Base POP Begin: 02-01-2022 POP End: 01-31-2023

0001AB

339.00
CS
__________________
__________________

Backlog - Case Abstracts

POP Begin: 02-01-2022 POP End: 01-31-2023

0001AC

363.00
CS
__________________
__________________

Backlog - Case Follow-ups

POP Begin: 02-01-2022 POP End: 01-31-2023

0001AD

240.00
CS
__________________
__________________

Maintenance - Case Finding

POP Begin: 02-01-2022 POP End: 01-31-2023

0001AE

100.00
CS
__________________
__________________

Maintenance - Case Abstracts

POP Begin: 02-01-2022 POP End: 01-31-2023

0001AF

100.00
CS
__________________
__________________

Maintenance - Case Follow-ups

POP Begin: 02-01-2022 POP End: 01-31-2023

0.00
CS
__________________
__________________

Cancer Registry Services

Contract Period: Option 1 POP Begin: 02-01-2023 POP End: 01-31-2024

1001AA

240.00
CS
__________________
__________________

Maintenance - Case Finding Contract Period: Option 1 POP Begin: 02-01-2023 POP End: 01-31-2024

1001AB

100.00
CS
__________________
__________________

Maintenance - Case Abstracts

POP Begin: 02-01-2023 POP End: 01-31-2024

1001AC

100.00
CS
__________________
__________________

Maintenance - Case Follow-ups

POP Begin: 02-01-2023 POP End: 01-31-2024

0.00
CS
__________________
__________________

Cancer Registry Services

Contract Period: Option 2 POP Begin: 02-01-2024 POP End: 01-31-2025

2001AA

240.00
CS
__________________
__________________

Maintenance - Case Finding Contract Period: Option 2 POP Begin: 02-01-2024 POP End: 01-31-2025

2001AB

100.00
CS
__________________
__________________

Maintenance - Case Abstracts

POP Begin: 02-01-2024 POP End: 01-31-2025

2001AC

100.00
CS
__________________
__________________

Maintenance - Case Follow-ups

POP Begin: 02-01-2024 POP End: 01-31-2025

0.00
CS
__________________
__________________

Cancer Registry Services

Contract Period: Option 3 POP Begin: 02-01-2025 POP End: 01-31-2026

3001AA

240.00
CS
__________________
__________________

Maintenance - Case Finding Contract Period: Option 3 POP Begin: 02-01-2025 POP End: 01-31-2026

3001AB

100.00
CS
__________________
__________________

Maintenance - Case Abstracts

POP Begin: 02-01-2025 POP End: 01-31-2026

3001AC

100.00
CS
__________________
__________________

Maintenance - Case Follow-ups

POP Begin: 02-01-2025 POP End: 01-31-2026

0.00
CS
__________________
__________________

Cancer Registry Services

Contract Period: Option 4 POP Begin: 02-01-2026 POP End: 01-31-2027

4001AA

240.00
CS
__________________
__________________

Maintenance - Case Finding Contract Period: Option 4 POP Begin: 02-01-2026 POP End: 01-31-2027

4001AB

100.00
CS
__________________
__________________

Maintenance - Case Abstracts

POP Begin: 02-01-2026 POP End: 01-31-2027

4001AC

100.00
CS
__________________
__________________

Maintenance - Case Follow-ups

POP Begin: 02-01-2026 POP End: 01-31-2027

GRAND TOTAL
__________________

B.5 STATEMENT OF WORK

The Contractor shall provide all necessary staffing and resources needed to properly maintain the Battle Creek V.A. Medical Center’s Cancer Registry database in accordance with 100% of the current American College of Surgeons Commission on Cancer, Cancer Registry standards and Veterans Health Administration (VHA) Cancer Registry requirements. The Contractor shall have current experience managing a Cancer Registry program within the last twelve months and have recent experience as a consultant with the American College of Surgeons (ACOS) Commission on Cancer (CoC). The duties and responsibilities of the Contractor shall include:

A. Case finding – The Contractor shall electronically screen and accept all cases into the Cancer Registry database, shall flag all cases as “suspense” with demographics and ensure cases are primary site coded. Responsible for monthly review of disease indices, pathology reports, radiology reports, treatment logs, and other computerized methods to identify reportable cancer cases. Responsible to transcribe and interpret information from patient records regarding treatment provided to an estimated 100 new cancer patients annually using the approved Veterans Administration (VA) abstracting software program (currently the VistA Oncotrax). The cancer patient’s medical record is reviewed and abstracted 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 Battle Creek VAMC Cancer Registry (TCR). The contractor will be a VA experienced Certified Tumor Registrar (CTR), and produce proof of current credential status, to provide abstracting services. Cases should be abstracted within 4-6 months of the cancer diagnosis.

B. Rejects – The Contractor shall delete those cases in the database that need to be purged because the case does not meet the requirements for a reportable case.

C. Case Abstracting and Coding – Abstracting is defined as coding and entering patient and disease specific information into the Veterans Administration Vista Cancer Registry database or other databases as identified within this statement of work, e.g. the Rapid Quality Reporting System (RQRS database). The Contractor shall utilize approved codes as indicated, i.e. ICD-O, ICD-10-CM, etc. as appropriate. The Contractor shall abstract oncology cases with 100% accuracy and shall ensure that all Commission on Cancer requirements/standards are met. The Contractor shall ensure that all cases are cleared (within pre-established timeframes) in terms of passing all edits required by the VA Central Cancer Registry or by the American College of Surgeons Commission on Cancer, e.g. National Cancer Database edits, Vista Oncology package edits, Gen-edits Program edits, etc. 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 cancer patient’s medical record is reviewed and abstracted 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 Michigan Cancer Registry (MCR). The contractor will be a VA experienced Certified Tumor Registrar (CTR), and produce proof of current credential status, to provide abstracting services. Cases should be abstracted within 4-6 months of the cancer diagnosis.

D. Follow-up – The Contractor shall complete data entry to include all required Commission on Cancer Registry fields, including but not limited to text, recurrence, treatment and required death information fields. Responsible for tracking the care all patients received in the years following their cancer diagnosis at the Battle Creek VA Medical Center, and at other health care institutions. A trained follow-up clerk may provide these services. Contractor shall provide the Cancer Registry function of Follow-up as described in the Standards of the American College of Surgeon’s Commission on Cancer (ACOS CoC); Facility Oncology Registry Data Standards (FORDS). These functions shall include computer input, data review and report generation tailored to the needs of the VA. Contractor shall provide follow-up of living cancer patients in compliance with accepted industry standards, posting information on recurrence, subsequent therapy, date of last contact, vital status, cancer status, any comments supporting the findings. Outcome data shall be included when applicable. Follow-up shall be maintained at a minimum of 90% on all patients in the registry data base, this is required to use registry data for survival (outcome) analysis, which is industry standard. Cases are delinquent (lost) if the follow-up interval exceeds 15 months. Contractor shall provide a list of patients completed follow-up along with monthly invoice.

E. Quality Assurance Surveillance Plan (QASP) – The contractor will provide quality work, complete work, and accuracy as evidenced by meeting Commission on Cancer, National Cancer Data Base, Michigan Cancer Registry, National Cancer Registrars Association (NCRA), and VA Central Cancer Registry standards and requirements. Contractor shall perform a 100% quality assurance review on all newly abstracted cases for compliance noting any deficiencies or non-deficiencies. A list shall be forwarded to the Contracting Officer Representative (COR) via e-mail monthly noting any deficiencies or non-deficiencies at least once monthly preferably with monthly invoices.

The Contractor shall Institute a Cancer Registry Quality Assurance Surveillance Plan/Program to evaluate the quality of 100% of their staff’s Cancer Registry data and 100% of their staff’s Cancer Registry activities done on behalf of the Battle Creek Veterans Administration Medical Center. The Contractors’ quality assurance plan shall minimally consist of the following:

1. Sets the review criteria

2. Sets the quality control timetable

3. Specifies the quality control methods, sources, and individuals involved

4. Required activities

5. Random sampling of annual analytic caseload

6. Identifies the activities to be evaluated:

F. QASP required activities

1. Case finding

2. Abstracting timeliness

3. Accuracy of abstracted data

a. Class of Case

b. Primary Site

c. Histology

d. AJCC Stage

e. Collaborative Stage

f. First Course of Treatment

g. Follow-up information, including Date of First Recurrence, Type of First Recurrence, and Cancer Status

4. The percentage of information coded as unknown (usually coded as 9 or a string of 9s)

5. NCDB data submission, correction of data errors, and resubmission of corrected data.

6. Required accuracy – 100%

7. Cancer Registry data submitted to the NCDB meet the established quality criteria included in the annual NCDB

8. All other standards as outlined in the most current edition of the ACOS Commission on Cancer manual are met or exceeded.

Contractor monitoring must be conducted at least once monthly and the Contractor will send their Quality Assurance Surveillance Plan (QASP) report findings to the COR and Cancer Program Administrator monthly, at a minimum. The QASP should also include your process for conducting monthly random case finding audits and include a sample of the audit findings to demonstrate that all eligible analytical cases were reviewed and processed; Contractor will send report findings back to the facility’s COR and Cancer Program Administrator monthly and/or upon request. In addition, the QASP will include monthly abstracting quality control audit checks on 100% of cases abstracted by your staff to ensure that abstracts are 100% edit free prior to invoicing The QASP will reflect your process for error corrections for all tasks performed by the Contractors’ staff and all tasks as required by the American College of Surgeons-Commission on Cancer for full accreditation; all errors identified either by you or by the facility’s COR or by the facility’s Certified Tumor Registrar or any representative of the Battle Creek VA Medical Center will be will be corrected by the Contractor within one working day. The Contractor monitors each area of Cancer Registry activity, ensures that all duties performed e.g. case finding, accessioning, follow up, edit corrections, data submissions, abstracting, etc. (i.e. all Cancer Registry tasks required by the American College of Surgeons- Commission on Cancer) are performed by a Certified Tumor Registrar. The Contractor provides written reports upon request and at least once monthly to the COR and Cancer Program Administrator and takes corrective action on any area(s) that falls below the measures specified in the QASP (the QASP must be submitted with the Contractors’ proposal for approval prior to award of contract). The Contractor’s Cancer Registry Quality Assurance Surveillance Plan ensures that:

1. 100% of cases are abstracted within 4 - 6 months of the patient’s first contact with the program.

2. 80% follow-up rate is maintained on all patients from the Cancer Registry reference date.

3. 90% follow-up rate is maintained on all patients diagnosed within the last 5 years.

4. complete error free data is properly submitted annually (or as required by the NCDB) for the National Cancer Database (NCDB) call for data.

5. Submits data to the VA, MCR, Karmanos, Cancer Committee and to the VA Central Cancer Registry upon request prior to or within deadlines.

6. Data re-submitted, e.g. to the NCDB and to all other requestors, e.g. VA Central Cancer Registry on cases diagnosed on or after the Cancer Registry reference date meet the quality criteria and resubmission deadline specified in the VA Central Registry or NCDB Calls for Data.

7. Monthly, reviews the quality of Cancer Registry abstracting through of 100% of the annual analytic caseload. The plan identifies the activities to be evaluated and sets the benchmarks for required accuracy to meet all ACOS cancer program standards; the review of all pathology/radiology/Computerized Patient Record System (CPRS) and Vista Imaging reports is included in the plan.

G. Education/CTR Certification: The contractor will show proof that those providing abstracting services are Certified Tumor Registrars through the National Cancer Registrars Association. Contractor personnel functioning under this contract shall be certified by the National Cancer Registrars Association. Contractor shall verify its personnel’s’ current certification status with the National Cancer Registrars Association and shall provide evidence of certification along with their proposal submission. Ongoing cancer-related education enhances knowledge and skills. All Contractor Cancer Registry staff who performs case abstracting must:

1. Hold a current Certified Tumor Registrar (CTR) credential. The CTR credential is granted through the National Cancer Registrars Association, which provides details on eligibility, testing, and recredentialing. High-quality Cancer Registry data are 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. Certified Tumor Registrars apply knowledge obtained from formal education and work experience to correctly interpret and code cancer diagnosis, stage, treatment, and outcomes information for each case that is seen at the Battle Creek VA Medical Center CoC accredited program that meets CoC reporting requirements. The case abstracting responsibilities of the CTR are documented by the Contractor.

During the on-site visit, upon Contract award and upon request, the Contractor provides the following:

1. Confirmation of a valid CTR credential for all certified staff working on this contract.

2. Verification of the date of hire to perform case abstracting in the Cancer Registry To facilitate accurate data collection and to gain or maintain their credentials, all members of the Cancer Registry staff participate in ongoing cancer-related education at the local, state, regional, or national level. Full-time and part-time registry staff for whom annual education is required are:

1. CTR staff

2. Contract CTR staff who are contracted to work for 3 or more consecutive months during the calendar year, regardless of the number of hours worked

3. This education includes, but is not limited to, topics in the following areas:

a. Advances in cancer diagnosis and treatment

b. Changes in cancer program standards

c. Changes in data collection requirements In addition, the Contractor shall provide documentation upon request and annually that all members of their Cancer Registry staff participate in one cancer-related educational activity other than cancer conferences. Certified Tumor Registrar (CTR) Contractor staff participate in at least one cancer related educational activity other than cancer conferences at the local, state, or national level; this education includes but is not limited to topics in the following areas: Advances in cancer diagnosis and treatment, changes in cancer program standards and changes in data collection requirements. Each year, all Contractor staff that work on this contract participate in 1 cancer-related educational activity other than cancer conferences; all members of the Contractors’ Cancer Registry staff participate in ongoing cancer-related education at the local, state, regional, or national level. All Contractor Cancer Registry staff participates in a cancer related educational activity each year. All CTR staff attend a national or regional cancer related meeting once during the 3-year survey cycle.

Per the Commission on Cancer Standards, Full-time and part-time registry staff for whom annual education is required are:

1. CTR staff

2. Contract CTR staff who are contracted to work for

3. 3 or more consecutive months during the calendar year, regardless of the number of hours worked

4. Management or supervisory personnel

5. This education includes, but is not limited to, topics in the following areas:

a. Advances in cancer diagnosis and treatment

b. Changes in cancer program standards

c. Changes in data collection requirements Educational activities that can be used to fulfill the standard include, but are not limited to, the following:

1. A cancer-related lecture offered by the program (local activity)

2. A face-to-face meeting or workshop

3. Local—involves 1 program or facilities located in 1 city (local activity)

4. State—involves 1 state (state activity)

5. Regional—involves more than one state organization working collaboratively to develop the workshop. Agendas and meeting notices indicate the collaborative effort (regional activity)

6. National—is sponsored by a national organization and targeted to a national audience (national meeting)

7. A video conference (local activity)

8. A webinar (local activity)

9. A Web-based training module (local activity)

10. Journal-based articles that offer continuing education credits (local activity) Educational activities exclude patient management cancer conferences in any format. National organizations that sponsor national meetings include, but are not limited to:

1. American Health Information Management Association (cancer-related educational activities)

2. Association of Community Cancer Centers

3. Commission on Cancer

4. National Cancer Registrars Association

5. National Comprehensive Cancer Network

6. North American Association of Central Cancer Registries Organizations that sponsor regional meetings include, but are not limited to:

1. Cancer Registrars Association of New England / Cancer Registrars Association of the Dakotas Additionally, the Contractor shall be responsible for completing and providing all Background Investigation, Information Security, Rules of Behavior, and Privacy Training documentation, and completing all other requirements needed for the Contractor’s employees to access the Battle Creek VA Medical Center network.

The 10 holidays observed by the federal Government are: New Year’s Day, Martin Luther King’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, and Christmas and any other specifically declared by the President of the United States to be a Federal holiday.

H. Policy and Procedure manual - The contractor is responsible for maintaining current Cancer Registry policies and procedures in compliance with CoC, NCDB, MCR and VACCR standards, and submitting them to the COR at the Battle Creek VA Medical Center annually (or upon request) for review. The Contractors’ Cancer Registry policy and procedure manual must be specific to the Battle Creek Veterans Administration Medical Center and specify that current CoC data definitions and coding instructions are used to describe all reportable cases. The Contractor uses the data standards defined by the CoC appropriate for the year of diagnosis for any specific case. The Contractors’ Cancer registrars may be required to comply with additional mandates pertaining to case and data reporting established by the Veterans Administration, federal or state government or by the Battle Creek VA Medical Centers’ cancer committee. The Cancer Registry policy and procedure manual may include, but is not limited to, the following:

1. Abstracting

2. American Joint Committee on Cancer (AJCC) and Collaborative Stage staging policies

3. Cancer Registry reference date

4. Case eligibility

5. Case finding

6. Case accessions

7. Confidentiality and release of information

8. Computer operations

9. Dates of implementation or changes in policies for registry operations

10. Disaster recovery policy

11. Documentation of first course of treatment

12. Follow-up

13. History of the registry for the program or health system (which may include facility mergers, network formation, facility name changes, vendor information, and identification of previous staff)

14. Job descriptions

15. Maintaining and using the suspense system

16. NCDB reporting requirements and mechanisms

17. Operational requirements for facility-based cancer registries

18. Policy for CoC SAR documentation

19. Quality control of registry data

20. Registry purpose

21. Request log

22. Required coding manuals

23. Retention of documents

24. State registry reporting requirements and mechanisms For the Policy and Procedure Cancer Registry manual, the Contractor provides a table of contents in accordance with Commission on Cancer standards.

I. Outcome Studies / Special Studies: Responsible for providing Cancer Registry data for outcome studies special studies and assisting with preparation of the reports. The contractor will provide outcome studies / special studies for the medical staff, Cancer Committee, Cancer Conference / Tumor Board, Veterans Administration Central Cancer Registry (VACCR), and quality management upon request with no additional cost. The data is compared to national data for comparison to determine effectiveness of treatment, programs, and survival. The contractor will also provide patient care evaluation studies for the annual cancer program report at no additional cost.

J. Corrections: Contractor will correct any mistakes in the registry cases made by them at no cost to the VA. This includes any data corrections as a result of edit error reports received from the NCDB, MCR or VACCR or records rejected because they lack supporting English text and/or have missing data elements. Contractor shall correct all inconsistencies found through any quality assurance review within 1 month (or sooner if it impacts adversely on accreditation of the cancer program) of submission of inconsistencies, errors, warnings, or any other data quality problems at no additional cost to the VA.

K. Other - The Contractor shall ensure that all American College of Surgeons Commission on Cancer Cancer Registry standards, requirements and initiatives are implemented and met; this includes but is not limited to ensuring that all Rapid Quality Reporting System (RQRS) requirements are met and includes developing a Cancer Registry policy and procedure manual which meets the current Commission on Cancer Standards. If abstract are inadvertently re-opened after being in the completed status (e.g. when Vista Oncotrax patches are put in for example) , Contractor will maintain thorough documentation as to the reason the case reopened on 100% of the cases entered into by the Contractor, will resolve the issue within one working day and will re-close the case and send the documentation to the COR or designee (monthly with the monthly invoice (this documentation may be reviewed by the ACOS Surveyor during the accreditation process). The Contractor may be asked to speak directly to a ACOS Cancer Program Surveyor; if requested, the Contractor will speak with the ACOS Surveyor at no additional costs to the government. Responsible for preparing Cancer Registry reports to the Cancer Committee which meets 4-6 times a year. Reports on TNM staging, timeliness of abstracting, follow-up, and quality improvement of the Cancer Registry services. The contractor will bear all the costs of reports prepared for Cancer Committee meetings.

L. ACoS / Commission on Cancer Approval: Responsible for coordinating the Cancer Registry portion of the Commission on Cancer / American College of Surgeons surveys in collaboration with the facility COR., facility Certified Tumor Registrar and facility Cancer Program Administrator and/or Physician Cancer Liaison ; responsible for assisting with preparation for the survey; updating the Survey Application Record in collaboration with the assigned Battle Creek VA Medical Center representative. The contractor, in conjunction assures that the Battle Creek VA Medical Center meets the standards of the American College of Surgeons Commission on Cancer Registry standards. The contractor and the Cancer Program Administrator have responsibility for the survey by the ACoS. The contractor will also provide phone consultation about Cancer Registry issues to the Battle Creek VA Medical Center upon request during normal working hours, Mondays through Fridays, 8:00am -4:30pm. Eastern Standard Time.

M. Reporting Cancer Data / Transmission of Data: Responsible for transmitting required submissions / resubmissions to the VA Center Cancer Registry (VACCR), National Cancer Data Base (NCDB), and the Michigan Cancer Registry (MCR) or Karmanos Cancer institute (KCI) within prescribed timeframes. Requests / maintains the required software for the transmissions. Submits complete and accurate reports, and makes corrections, as required. Demonstrates knowledge of the VACCR, NDCB, and MCR reporting requirements. Completes required privacy reports and submits them to the privacy officer in collaboration with the Battle Creek VA Medical Center Cancer Registry contact.

N. Data User Agreement with Veterans Administration and the State of Michigan: Ensures that a current Data User Agreement or any other paperwork required by VA/VHA policy is in force with the State of Michigan and/or Karmanos Cancer Institute prior to submitting or transmitting requested data.

O. Continuing Education / Competency: The contractor should show proof of attendance at recent continuing education activities including state Cancer Registry trainings and Cancer Registry association education meetings. The contractor will maintain competency / training folders and make them available as requested. The contractor and contractor staff should have a working knowledge of VA abstracting software programs and computer hardware. If the COR has a concern about competency, the contractor staff may be requested to take the NCRA Cancer Registrar Employment Screening at the contractor’s cost to evaluate competency, or request a VA CTR review a specified number of abstracts to evaluate competency and ensure required elements are being completed. If the National VA Central Cancer Registrar documents continued uncorrected errors and quality problems from the contractor, this will be considered adequate documentation to terminate the contract due to quality concerns.

P. VA-Specific / Privacy Training - The contractor will complete the VHA Privacy Policy Training and Cyber Security training, and any other mandated training, at their own cost before access is given, at no cost to the government. HIPPA coverage shall be disclosed at time of quote. If there is no HIPPA coverage a Business Associate Agreement is required.

Q. Security/Background Checks – A security background check is required for each contractor personnel who will be providing services on this contract. Security background checks will be processed by the COR, services shall not be provided until initial clearance is given.

R. Computerized Patient Record System (CPRS) in VISTA/Electronic Health Record (EHR). VA will provide contractor with electronic access to CPRS/EHR 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. If necessary, VA will provide Contractor with remote access to the Computerized Patient Record System (CPRS) in VISTA/EHR. It is expected that electronic access will be done monthly. Contractor’s abstracting personnel may perform the abstracting functions from remote locations by computer modem and shall comply with the VA standard of case completion of four to six (6) months after date of diagnosis. A list of cases completed shall be provided to the Contracting Officer’s Technical Representative (COR) along with monthly invoices. Abstracting shall encompass the full and complete data set (required, optional and supplemental fields) to present a complete patient summary in the VistA Oncotrax package or EHR. Text field shall be utilized to document finds on Physical Exam, Scans, Scopes, Labs, Diagnostic OPS and Pathology. Collaborative Stage and AJCC TNM staging shall be performed on all cases meeting the criteria as established by SEER and the American Joint commission on Cancer, latest Manual for the Staging of Cancer, in conjunction with accepted principles. All required abstract fields must be completed with 100% accuracy.

S. INFORMATION MANAGEMENT

Documentation and record keeping shall be in accordance with VA policies and procedures. The Contractor shall adhere to all timeframes required by Battle Creek V.A. Medical Center policies and procedures for documentation and authentication in electronic medical records.

T. Destruction of Temporary Paper Records The contractor will ensure that all temporary paper records generated are destroyed in accordance with VA Directive 6371. The contractor will have a written procedure that outlines how paper records, if generated, will be destroyed in compliance with VA Directive 6371.

U. RECORDS MANAGEMENT OBLIGATIONS

1. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

2. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

a. includes Battle Creek VAMC records.

b. does not include personal materials.

c. applies to records created, received, or maintained by Contractors pursuant to their Battle Creek VAMC contract.

d. may include deliverables and documentation associated with deliverables.

3. Requirements

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. Battle Creek VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Battle Creek VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Battle Creek VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting…

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