36C25022Q0021 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE

OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERE

D CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendmen t, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) None Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 1100 Indianapolis IN 46240 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 1100 Indianapolis IN 46240 To all Offerors/Bidders

36C25022Q0021 12-17-2021

X X X

The purpose of this amendment is to update the Statement of Work to include the VA Supplemental COVID-19 requirements for contractors.

The attached Statement of Work replaces all previous versions in their entirety.

Sally L. Leitch Contracting Officer

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 Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Battle Creek VAMC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Battle Creek VAMC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Battle Creek VAMC policy.

h. The Contractor shall not create or maintain any records containing any non-public Battle Creek VAMC information that are not specifically tied to or authorized by the contract.

i. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

j. The Battle Creek VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Battle Creek VAMC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Battle Creek VAMC-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

4. Flow-down of requirements to subcontractors

a. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

b. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

V. VHA Supplemental Contract Requirements for Combatting COVID-19:

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1. If fully vaccinated, shall show proof of vaccination

NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

1. If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

1. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

1. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website: COVID-19 Screening Tool. Check regularly for updates.

1. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces.

1. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

Update SOW to include the VA Supplemental COVID Requirements