36C25019Q0637-002.docx

36C25019Q0637

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

553-19-4-2115-0056 36C25019Q0637 05- -2019 Kelly Poole 734-222-6177 05-29-2019 12:00 pm Department of Veterans Affairs Network 10 Contracting Office Ann Arbor VA Healthcare System 2215 Fuller Road Ann Arbor MI 48105 X X 541611 $15 Million X N/A X Department of Veterans Affairs John D. Dingell Medical Center 4646 John R. Street Detroit MI 48201 Department of Veterans Affairs Network 10 Contracting Office Ann Arbor VA Healthcare System 2215 Fuller Road Ann Arbor MI 48105

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 512-242-7300 N/A See CONTINUATION Page The contractor shall provide cancer registry services to the John D. Dingell VA Medical Center, Detroit, Michigan, in accordance with the Statement of Work, clauses, and provisions contained herein.

All questions and requests for information must be submitted to kelly.poole@va.gov by May 17, 2019 at 12:00pm Eastern.

This procurement will be conducted under the procedures of

FAR 13.5.

Please see page 82 for Instructions to Offerors.

See CONTINUATION Page X X X one Kelly Poole Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

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

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 [NA] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted via www.OB10.com to the following address:

amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 REVIEW REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

(a) As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $250,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

(b) Each contractor whose contract award is estimated to exceed $150,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the contractor's registered representative.

(c) For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor's performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor's designated representative for comment. The contractor representative will have sixty days to submit any comments and re-assign the report to the VA contracting officer.

(d) Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those sixty days, will result in the Government's evaluation being placed on file in the database with a statement that the contractor failed to respond.

B.3 SCHEDULE OF SERVICES

The Contractor shall provide Cancer Registry Services for the John D. Dingell V.A. Medical Center, Detroit in strict accordance with the Statement of Work as well as all contract clauses.

CASELOAD QUANTITIES ARE ESTIMATES ONLY. The total minimum quantity, or guaranteed minimum, for the contract is $10,000.00 over the life of the contract. The maximum total quantity to be ordered under the contract shall not exceed $600,000.00 over the life of the contract.

Ordering Period I: (July 1, 2019 - June 30, 2020)

ITEM

NO.

1.

Cancer Registry Services Case Finding (Est. based on previous year average )

1 EA

2.

Cancer Registry Services Case Abstracts (Est. based on previous year average)

1 EA

Follow-ups

1 EA

Consult Hours

1 EA

Ordering Period II (July 1, 2020 – June 30, 2021)

ITEM

NO.

Cancer Registry Services Case Finding (Est. based on previous year average )

Cancer Registry Services Case Abstracts (Est. based on previous year average)

1 EA

Follow-ups

1 EA

Consult Hours

1 EA

Ordering Period III: (July 1, 2021– July 30, 2022)

ITEM

NO.

Cancer Registry Services Case Finding (Est. based on previous year average )

Cancer Registry Services Case Abstracts (Est. based on previous year average)

1 EA

Follow-ups

1 EA

Consult Hours

1 EA

Ordering Period IV: (July 1, 2022 – June 30, 2023)

ITEM

NO.

Cancer Registry Services Case Finding (Est. based on previous year average )

Cancer Registry Services Case Abstracts (Est. based on previous year average)

1 EA

Follow-ups

1 EA

Consult Hours

1 EA

Ordering Period V: (July 1, 2023 – June 30, 2024)

ITEM

NO.

Cancer Registry Services Case Finding (Est. based on previous year average )

Cancer Registry Services Case Abstracts (Est. based on previous year average)

1 EA

Follow-ups

1 EA

Consult Hours

1 EA

Estimated Quantities for Each Line Item During Each Ordering Period

ITEM

NO.

QTY.

UNIT

Cancer Registry Services Case Finding

1,400

EA

Cancer Registry Services Case Abstracts

Follow-ups 2,500

EA

Consult Hours

EA

B.4 STATEMENT OF WORK

The Contractor shall provide all necessary staffing and resources needed to properly maintain the John D. Dingell 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 an accredited 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 300 - 400 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 John D. Dingell 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-9-CM, 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 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 John D. Dingell 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. Consult Hours: The Contractor shall provide Consult Hours that shall include time spent working with Health Information Managers, the Cancer Committee and the Cancer Program/Hospital Administrator. Consult hours shall also include ensuring that all current ACOS and related Cancer Registry standards pertaining to the John D. Dingell Veterans Administration Medical Center Cancer Registry are met, that all data entered the Cancer Registry is 100% accurate and that all pre-established timeframes related to the Cancer Registry are met. Consult hours shall also include producing reports, ensuring that the Cancer Registry Policy and Procedure Manual meets the Commission on Cancer Standards and is up to date, and assisting and advising all Cancer Program staff and related staff with Commission on Cancer survey readiness and preparation. Consult hours shall also include preparation of data for transmission to the Central VA Office and any other entity as required by the VA or American College of Surgeons. The contractor will provide consultative services both by telephone and on site to assist in the Commission on Cancer approval process.

F. National Cancer Database (NCDB): The Contractor shall conform to all ACOS Commission on Cancer requirements relating to the National Cancer Database (NCDB), including but not limited to, timely accurate submissions, timely accurate resubmissions, correcting edits, and monitoring CoC flash newsletters to ensure compliance with all Cancer Registry and related deadlines, etc. Cancer Registry data submitted by the Contractor to the NCDB shall meet the established quality criteria 100% of the time, as outlined in the NCDB Call for Data. Annually, cases submitted by the Contractor to the National Cancer Data Base (NCDB) that were diagnosed on January 1, 2003 or later meet the established quality criteria and resubmission deadlines as specified in the annual Call for Data.

G. Staging Alerts – At the time of case finding the Contractor shall send an email to the attending physicians confirming the completion of the staging form required by the American Joint Commission on Cancer. The Contractor shall carbon copy the Chief and Assistant Chief, Health Information management on all email messages sent from the Contractor to VA staff.

H. Rapid Quality Reporting System - The contractor monitors the quality of the Cancer Registry data. He or she will monitor the facility’s performance based on the CoC performance indicators, using the CoC reporting tools for the Rapid Quality Reporting System (RQRS). He or she will keep the COTR, Cancer Liaison Physician, the Chair of the Cancer Program and the Cancer Program Administrator advised of the performance status as requested by the above-mentioned staff and no less than once monthly. (RQRS is a real-time data collection program to assess hospital-level performance using National Quality Forum (NQF) endorsed quality of cancer measures).

I. 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 COTR via e-mail monthly noting any deficiencies or non-deficiencies at least once monthly preferably with monthly invoices.

The Contractor Will 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 John D. Dingell Veterans Administration Medical Center. The Contractors’ quality assurance plan does the following:

Identifies the activities to be evaluated:

QASP required activities

i. Case finding

ii. Abstracting timeliness

iii. Accuracy of abstracted data

· Class of Case

· Primary Site

· Histology

· AJCC Stage

· Collaborative Stage

· First Course of Treatment

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

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

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

vi. Required accuracy – 100%

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

viii. 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 COTR 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 COTR 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 COTR or by the facility’s Certified Tumor Registrar or any representative of the John D. Dingell 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 COTR 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:

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

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

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

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

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

· 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.

· 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.

J. 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:

•• 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 John D. Dingell 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:

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

•• 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:

•• CTR staff •• 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 This education includes, but is not limited to, topics in the following areas:

•• Advances in cancer diagnosis and treatment •• Changes in cancer program standards •• 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:

•• CTR staff •• 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 •• Management or supervisory personnel This education includes, but is not limited to, topics in the following areas:

•• Advances in cancer diagnosis and treatment •• Changes in cancer program standards •• Changes in data collection requirements Educational activities that can be used to fulfill the standard include, but are not limited to, the following:

•• A cancer-related lecture offered by the program (local activity) •• A face-to-face meeting or workshop •• Local—involves 1 program or facilities located in 1 city (local activity) •• State—involves 1 state (state activity) •• Regional—involves more than one state organization working collaboratively to develop the workshop. Agendas and meeting notices indicate the collaborative effort (regional activity) •• National—is sponsored by a national organization and targeted to a national audience (national meeting) •• A video conference (local activity) •• A webinar (local activity) •• A Web-based training module (local activity) •• 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:

•• American Health Information Management Association (cancer-related educational activities) •• Association of Community Cancer Centers •• Commission on Cancer •• National Cancer Registrars Association •• National Comprehensive Cancer Network •• North American Association of Central Cancer Registries

Organizations that sponsor regional meetings include, but are not limited to;

•• 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 John D. Dingell 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.

K. 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 COTR at the John D. Dingell VA Medical Center annually (or upon request) for review. The Contractors’ Cancer Registry policy and procedure manual must be specific to the John D. Dingell 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 John D. Dingell VA Medical Centers’ cancer committee. The Cancer Registry policy and procedure manual may include, but is not limited to, the following:

•• Abstracting •• American Joint Committee on Cancer (AJCC) and Collaborative Stage staging policies •• Cancer Registry reference date •• Case eligibility •• Case finding •• Case accessions •• Confidentiality and release of information •• Computer operations •• Dates of implementation or changes in policies for registry operations •• Disaster recovery policy **Documentation of first course of treatment •• Follow-up •• 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) •• Job descriptions •• Maintaining and using the suspense system •• NCDB reporting requirements and mechanisms •• Operational requirements for facility based cancer registries •• Policy for CoC SAR documentation •• Quality control of registry data •• Registry purpose •• Request log •• Required coding manuals •• Retention of documents •• State registry reporting requirements and mechanisms

For the Policy and Procedure Cancer Registry manual, the Contractor provides a table of contents in accordance to Commission on Cancer standards.

L. 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.

M. 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.

N. 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 COTR 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.

O. 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 COTR., 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 John D. Dingell VA Medical Center representative. The contractor, in conjunction assures that the John D. Dingell 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 John D. Dingell VA Medical Center upon request during normal working hours, Mondays through Fridays, 8:00am -4:30pm. Eastern Standard Time.

P. 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 John D. Dingell VA Medical Center Cancer Registry contact.

Q. 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.

R. 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 COTR 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.

S. 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.

T. 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. If necessary, VA will provide Contractor with remote access to the Computerized Patient Record System (CPRS) in VISTA. 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 (COTR) 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. 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.

INFORMATION MANAGEMENT

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

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.

B.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this…