36C25021Q0601.docx

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H365--RSO Services and Equipment Testing
Solicitation number
36C25021Q0601
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This is a combined synopsis/solicitation for commercial items seeking quotes for Radiation Safety Officer and equipment testing services. The requirement is set aside for small business with a NAICS code of 541990. The anticipated period of performance is from July 2021 to July 2022 with four one-year option periods. Services will be performed at the John D. Dingell VA Medical Center in Detroit, Michigan. FAR provisions 52.212-1, 52.212-4 and 52.212-5 apply. Offers must be submitted electronically by the date and time specified to the contracting specialist at the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 10. The solicitation incorporates provisions from FAR 2021-05 and includes CLINs in the attached SF1449.

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36C25021Q0601

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

553-21-2-3047-0050 36C25021Q0601 -2021 Jeremy Boston 734-222-7154 06-1 -2021 10:00

EDT

Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105 X X 541990 $16.5 Million N/A X Department of Veterans Affair John D Dingell VA Medical Center 4646 John R Street Detroit, MI 48201

Y Department of Veterans Affair Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page The contractor shall provide a quote for Radiation Safety Officer and equipment testing services in accordance with the Statement of Work and the Price/Cost Schedule.

Estimated period of performance is 08/01/2021 - 07/31/2022.

Subsequent contract will be a base year with four, one-year options.

See CONTINUATION Page X X X Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.2 STATEMENT OF WORK4
B.3 PRICE/COST SCHEDULE13
ITEM INFORMATION13
B.4 IT CONTRACT SECURITY15
SECTION C - CONTRACT CLAUSES25
C.1 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)25
C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)25
C.3 SUPPLEMENTAL INSURANCE REQUIREMENTS25
C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)26
C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)28
C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION)28
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS37
SECTION E - SOLICITATION PROVISIONS38
E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS38
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)40
E.3 52.216-1 TYPE OF CONTRACT (APR 1984)42
E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)42
E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)43
E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)44

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:____________________________
POC: _________________________
Phone: __________________
Email: _______________________________

b. GOVERNMENT: Contracting Officer 36C250 Jeremy Boston Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

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

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Monthly

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

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

AMENDMENT NO
DATE

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

MEDICAL PHYSICIST AND RADIATION SAFETY OFFICER – DETROIT VA

BACKGROUND

The Department of Veterans Affairs Detroit Medical Center (DVAMC) has the need for the services of a Radiation Safety Officer (RSO)/ Medical Physicist. The contractor shall furnish the services of Radiation Safety Officer and Medical Physicist.

The contractor will ensure that VA meets the standards of the:

National Health Physics Program (NHPP) (http://www.patientcare.va.gov/nhpp.asp) Nuclear Regulatory Commission (NRC) www.nrc.gov Joint Commission on Accreditationwww.jointcommission.org The American College of Radiology (ACR) practice guidelines http://www.acr.org/~/media/ACR/Documents/PGTS/standards/ElectronicPracticeMedImg.pdf The contractor shall adhere to the following policy/handbooks:

VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

Veterans Health Administration (VHA) Directive 2006-041 “Veterans’ Health Care Service Standards” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 VHA Handbook 1100.17: National Practitioner Data Bank Reports - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

VHA Handbook 1100.18 Reporting And Responding To State Licensing Boards - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 VHA Handbook 1100.19 Credentialing and Privileging – http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 VHA Directive 2012-030 Credentialing of Health Care Professionals – http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

The Radiation Safety Officer/Medical Physicist shall:

· Implement and maintain the Radiation Protection Program as referenced in NRC: 10 Code of Federal Regulations (CFR) 20.1101.

· Implement and maintain a program that meets the requirement of Directive 1105, Management of Radioactive Materials.

· Maintain a program following the guidance found in NUREG-1556 Consolidated Guidance About Materials Licenses.

· Be able to be named on our NHPP permit as the RSO for the following sections and activities:

· 35.100

· 35.200

· 35.300

· Research

· Report in writing quarterly to the facility on compliance to National Health Physics Program (NHPP), The Joint Commission (TJC), and Veterans Health Administration (VHA) standards for Computed Tomography, Nuclear Medicine, Magnetic Resonance Imaging, Diagnostic Radiology, Dental and C- arm.

· Ensure that the DVAMC location meets all NHPP, NRC, state, federal, and Joint Commission requirements and exists in a state of compliance for all inspections. The contractor shall submit a report quarterly to the facility regarding compliance or proposed changes in regulations and therefore local procedures. A copy of this report shall be kept by the contractor in accordance to NRC 10 CFR 20.1101 and a copy given to the Contracting Officers Representative, the Chief, Safety services and the Chief, Biomedical engineering within five working days.

· Assist the DVAMC administration in the conduct of the institution’s radiation safety, quality management, and As Low As Reasonably Achievable (ALARA) programs by reviewing, suggesting areas for improvement, updating policies, and or Medical Center Memorandums pertaining to these topics, procedures, and any service guidelines. The contractor shall submit all updated policies and or Medical Center Memorandums within two business days of completion to the Chief, Safety Service and the contractor shall also maintain a copy.

· Assists with all records required by the state, federal and hospital accreditation agencies are completed timely, updated per regulations, and on file at the DVAMC with a back-up copy to be maintained by the contractor. All documentation referenced in this specification shall be submitted within five (5) working days to the Contracting Officer’s Representative and Chief, Safety Service.

· Attend the Radiation Safety Committee/Laser Safety Committee at least quarterly and address all standing items as listed in Directive 1105 such as but not limited to;

Patient safety concerns Nursing/radiologist radiation safety training Personal dosimetry status report and ALARA Footprint measurement status Security status review Status of the written directives Nuclear medicine quality control review Radiology

· Attend the MRI Safety Committee quarterly and assists the committee all standing items such as but not limited to:

Announcements Approval of minutes Old business New business Training Safety issues and incidents Emergency response drill which should cover one of each of the following on a quarterly basis

1. Pinned in the magnet

2. Cardiac arrest

3. Fire

4. Contrast reaction

Review of action items:

· Review radiation safety practices and investigate deviations from the radiation safety practices approved by facility management and/or the Radiation Safety Committee/Laser Safety Committee, if applicable.

· Review and submit by signature the Radiation Safety Committee/Laser Safety Committee minutes and MRI Safety Committee minutes within five (5) business days to the Chief, Safety Service and the Contracting Officer’s Representative (COR) after each quarterly meeting or more often when applicable when or if additional meetings are required such as but not limited to over exposure, accidental spills and so on.

· Perform an annual review of the radiation safety program and submit a written summation of findings that meet all regulatory guidelines as listed previously to the COR and the Chief, Safety Service no later than January 31st of each year.

· The contractor shall conduct an annual review of DVAMC all policy and all procedure manuals pertaining to ionizing radiation safety for DVAMC campus. During the period of the contract, the contractor shall continually update these manuals to meet existing guidelines of the NHPP, NRC, state, federal and hospital accreditation authorities. The contractor shall inform the Chief, Safety Service and the COR of all changes made to the policies and procedures within two (2) business days of the signed final document.

· The contractor shall remain compliant at all times with any requirement changes as mandated by all regulatory agencies.

· The contractor shall return all urgent phone calls within two (2) hours and non-emergent phone calls within twenty-four (24) hours. Is also able to report, on-site, to respond to incidents/emergencies within four (4) hours when the DVAMC deems the physicist’s presence is essential.

· Follow all applicable VA and VHA policies, procedures and directives.

· Prepare license compliance renewals and amendments as per NHPP and NRC requirements for the site.

· Preform annual physics evaluations using American College of Radiology (ACR) standards and phantoms on all equipment listed within each section as outlined. Provide certifications for each piece of equipment that can be displayed. A copy of these evaluations shall be provided no later than within thirty (30) days prior to the expiration of the previously issued equipment licensure and evaluation to the COR and the Chief, Safety Services.

· Review and monitor personnel radiation exposure reports monthly and provide written over-exposure reports if applicable.

· Review all incidents involving licensed materials and provide written incident reports that meet all NHPP and NRC guidelines. A copy of the report involving this standard must be provided to the Chief, Safety Services and the COR.

· Assist in the preparation of administrative reports required by the NHPP, the NRC or the DVAMC.

· Ensure annual training is complete (or upon hiring a new employees) of Nuclear medicine staff and other Safety staff regarding proper handling of radioactive materials and sealed sources, annual fluoroscopy safety training to Radiologists. Documentation of all training will be complied by the contractor and submitted to the COR and the Chief, Safety Services.

· Conduct duties while maintaining a safe environment at all times.

· Perform all needed actions to bring the PET/MRI online and in compliance with NRC and NHPP regulations and guidelines.

1. Completing or providing oversight for the radiation safety program through periodic reviews and audits, to include:

a. Reviewing annually the radiation safety program review as specified in 10 CFR 20.1101, to include locations of use with emphasis on decommissioning records as specified in 10 CFR Part 30.

b. Reviews or audits as needed, the radioactive materials scope of use.

c. Evaluation of results from audits, reviews and inspections to determine possible generic issues or trends. Identify root causes, specify corrective actions and actions to prevent recurrence, and determine if any results are applicable to other uses of radioactive materials.

d. Distribution of results of audits, reviews and inspections to all work centers and availability to the staff working with or around radioactive materials.

e. Oversight and follow-up to resolve health and safety issues and radiation safety program deviations as needed.

f. Reviewing, at least every 6 months, occupational and public doses.

2. Reviewing, at least every 6 months, any identified health and safety issues or possible radiation safety program deviations from regulatory compliance or required practices.

3. Reviewing and approving training and experience for prospective Radiation Safety Officers, authorized users and other staff requiring regulatory approval.

4. Reviewing and approving proposed changes applicable to training, equipment, facilities and radiation safety procedures or practices.

5. Ensuring sealed source inventories are completed:

a. Quarterly, for sealed sources with either current activity greater than 1 millicurie or current activity greater than 1000 times the quantities in 10 CFR Part 20, Appendix C.

b. Semiannually, for all other sealed sources except sources specifically exempted by 10 CFR 30. 11. Ensuring sealed source records are maintained for transfer or disposition to document leak test results, if the sealed source was required by regulation or permit condition to have a leak test.

6. Providing results if requested, for sealed source inventories and leak tests to NHPP.

7. Providing oversight for security of radioactive materials by:

a. Compliance with regulations in 10 CFR 20.1801, 20.1802, and 10 CFR Part 37.

b. Assists the agency to minimize adversary or unauthorized removal of radioactive materials.

c. Compliance with the security guidelines in VHA Handbook 1200.06, Control of Hazardous Agents in VA Research Laboratories.

d. Assists the agency in taking on adequate security commensurate with possible risks of radioactive materials unauthorized use.

e. Classifying sealed sources, not in active use for their intended clinical or research purpose for a period of 24 months, as disused sources and evaluating the disused sources for disposal as expeditiously as possible.

8. Assisting the radiation safety program implementation to be consistent with the program codes (i.e., whether broad-scope or limited-scope medical or research uses) and permitting conditions approved for the permittee.

9. Ensuring approvals for authorized users and locations of use (except as authorized per 10 CFR 35.14) are limited to broad-scope permittees.

10. Ensuring compliance with posting requirements specified in 10 CFR Part 19 and 21.6, as in the following.

Periodically evaluate “action levels” for continued appropriateness to ensure compliance with NRC: 10 CFR 20.1501 and 1502 for the following:

· Personal exposure investigation levels;

· Area surveys, dose rate and contamination levels;

· Bioassays, if necessary; and

· Radioactive effluent concentrations, if necessary.

Review the following Radiation Protection Program records:

· Sealed source inventories;

· Sealed source leak tests;

· Dose calibrator linearity tests;

· Dose calibrator accuracy tests;

· Dose calibrator geometrical variation tests;

· Occupational radiation exposure reports;

· Medical event documentation;

· Spill/incident reports for cause and corrective action; and

· Dose rate and contamination survey results.

Assist to ensure the use of reasonable practices and controls to strive to maintain doses to workers and to the public are ALARA, in compliance with NRC: 10 CFR 20.1101(b).

Review with facility management annually of the content of the Radiation protection Program and determine if the written program is being implemented in compliance with NRC: 10 CFR 20.1101(c).

Assist to ensure as a part of the ALARA effort that individual members of the public shall not receive a Total Effective Dose Equivalent (TEDE) of more than 10 millirems ( mrem) 0.1millsieverts ( mSv) per year from airborne radioactive material releases as per 10 DFR 20.1101(d) as necessary.

Attend the Radiation Safety Committee/Laser Safety Committee that will oversee all uses of byproduct material permitted by the license as per NRC: 10 CFR 35.24(f).

The Radiation Safety Officer/Medical Physicist shall provide annual evaluation and calibration of nuclear medicine equipment including:

· Scintillation cameras

· Thyroid uptake systems

· Well counters

· Dose calibrators

· Survey meters

The Radiation Safety Officer/Medical Physicist shall provide the following:

· ACR level annual Performance Testing for equipment listed in Appendix A

· Dose calibrator accuracy tests;

· Dose calibrator linearity tests (shield method) (upon request);

· Uptake probe/well counter resolution and reproducibility tests;

· Radiation survey meter calibrations (NRC license 21-20153-01);

· Radionuclide sealed source leak tests (NRC license 21-20153-01);

· Radionuclide sealed source inventories and ambient surveys;

· Preparation of license renewals and amendments;

· Patient radiation dose estimate calculations per TJC; and

The Radiation Safety Officer/Medical Physicist shall be required to provide the following services in addition to those listed through this Statement of Work:

· Instruction, upon request, of personnel as required by state, federal, and accreditation agencies if performed in conjunction with quarterly audits;

· A review of incidents involving licensed material with respect to cause and subsequent actions taken and prepare incident reports;

· Preparation of misadministration/medical event reports;

· Conduct Nuclear Medicine Department Audits Quarterly;

· Attend the Radiation Safety Committee/Laser Safety Committee quarterly or more often if necessary.

· Be reachable in person or by telephone for emergency situations

· Be available for inspections in person or by telephone; and

· Remains current in the ability to provide applicable services to continually changing inventory

· Provide inspection/review of lead shielding in new or renovated construction.

Be available for inspections in person or by telephone.

Computed Tomography (CT):

Shall for diagnostic computed tomography (CT) services within the current guidelines established by Joint Commission Accreditation, ACR and including VA policy and procedure;

· Perform ACR level annual performance testing of current equipment

· Perform ACR level performance testing upon acceptance of new equipment

· Perform ACR level performance testing upon repair of certified components relating to dose.

Diagnostic Radiology:

For Diagnostic Radiology services: Shall for diagnostic radiology services within the current guidelines established by Joint Commission Accreditation, ACR and including VA policy and procedure;

· Perform ACR level annual performance testing of current equipment

· Perform ACR level performance testing upon acceptance of new equipment

· Perform ACR level performance testing upon repair of certified components relating to dose.

The contractor shall perform and review the annual testing of lead garments. Report will be provided to the COR and Chief, Safety Service.

Dental Service:

For Diagnostic Radiology services: Shall for Dental services within the current guidelines established by Joint Commission Accreditation, ACR and including VA policy and procedure;

· Perform ACR level annual performance testing of current equipment

· Perform ACR level performance testing upon acceptance of new equipment

· Perform ACR level performance testing upon repair of certified components relating to dose.

The contractor shall also review annually the results of lead garment testing

Magnetic Resonance Imaging (MRI):

Shall for MRI services within the current guidelines established by Joint Commission Accreditation, ACR and including VA policy and procedure;

· Perform ACR level annual performance testing of current equipment

· Perform ACR level performance testing upon acceptance of new equipment

· Perform needed actions to bring the PET/MRI online including notification to the NHPP.

Nuclear Medicine:

Review executive management approved procedures that can include policy and technical issues which, would make up the Radiation Protection Program as follows:

· Authorization for the purchase of radioactive material;

· Receipt and opening of packages containing radioactive material;

· Storage of radioactive material;

· Inventory control of radioactive material;

· Safe use of radioactive material;

· Emergency procedures in the event of loss, theft, etc.;

· Periodic radiations surveys and wipe tests;

· Checks of radiation survey and other radiation safety instruments; and

· Disposal of radioactive material.

Oversee a record system of the Radiation Protection Program per NRC: 10 CFR 20.2102 to include the provisions of the Radiation Protection Program until the license is terminated by the Nuclear Regulatory Commission such as:

· All records, reports, written policies and procedures required by regulatory agencies concerning radioactive material; and

· A copy of the regulations governing the possession, use and disposal of licensed material, such as Title 10 Code of Federal Regulations.

QUALIFICATIONS OF THE MEDICAL PHYSICIST PORTION:

Board Certification - All contracted Medical Physicist(s) shall be board certified. All continuing education courses required for maintaining certification must be valid at all times with documentation provided to the VA Contracting Officer’s Representative (COR) upon request. Documentation verifying that board certification is in good standing and current (i.e. signed and dated certificate and/or letter from the American Board of Radiology) shall be provided by the Contractor to the COR on an annual basis for each year of contract performance. In addition, documentation (i.e. copies of degrees) of the medical physicists’ Master of Science (M.S.) degrees is to be provided to the COR.

Physicists must be Board Certified in Diagnostic Medical Physics by the one of the following approved certifying body:

a. The American Board of Radiology (ABR) in any of the following field titles: Radiologic Physics or Radiological Physics or

b. The American Board of Medical Physics (ABMP) with certification of American Board of Health Physics, or Canadian College of Physicist in Medicine.

Physicists also must maintain licensure with the Board of Licensure for Professional Medical Physicists, if applicable. Certification must be maintained throughout the contract performance period. In the event that Contractor’s Radiation Safety Officer/Medical Physicist is not directly employed by the treating facility, documentation must be provided to ensure adequate certification.

Education – For physicists with Master’s degrees or higher, the degree must be in a physics, science, or engineering discipline recognized by an accredited college or university with at least 30 semester hours in medical physics, health physics, radiological science, physics, engineering, chemistry, or biology; or an equivalent foreign degree and coursework substantiated by the National Association of Credential Evaluation Services.

QUALIFICATIONS OF THE RADIATION SAFETY OFFICER PORTION:

VHA Handbook 1105.1, Appendix C, paragraph 6, Medical Permit Authorizing Medical Use of Radioactive Materials for Diagnosis or Therapy, requires that the RSO have training as set forth in NRC: 10 Code of Federal Regulations ( CFR) Part 35, Subpart B, paragraph 35.50, Training for Radiation Safety Officer, as follows:

The RSO is certified by the –

· American Board of Health Physics in Comprehensive Health Physics;

· American Board of Radiology;

· American Board of Nuclear Medicine;

· American Board of Science in Nuclear Medicine;

· Board of Pharmaceutical Specialties in Nuclear Pharmacy;

· American Board of Medical Physics in radiation oncology physics;

· Royal College of Physicians and Surgeons of Canada in nuclear medicine;

· American Osteopathic Board of Radiology; or The RSO must have classroom and laboratory training and experience as follows –

· 200 hours of classroom and laboratory training that includes –

· Radiation physics and instrumentation;

· Radiation protection

· Mathematics pertaining to the

· Radiation biology; and

· Radiopharmaceutical chemistry; and

The RSO shall have one year of full time experience as a Radiation Safety Technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material or is an authorized user identified on the licensee’s license.

As set forth in VHA Handbook 1105.2, Appendix C, paragraph 9, Type A Permit of Broad Scope, the RSO shall additionally have the following training and experience:

· A college degree at the bachelor level or equivalent training and experience in the physical or biological sciences or in engineering.

· Documented experience in a clinical Computed Tomography (CT) environment conducting at least ten CT performance evaluations under the direct supervision of a board-certified medical physicist.

· Forty hours of formal RSO training, including instruction in the safe handling of radioactive material, characteristics of ionizing radiation, units of radiation dose and quantity, radiation detection and instrumentation, biological hazards of exposure to radiation, regulatory requirements of the NRC for radioactive material including accounting, reporting, using, transferring, shipping and disposing of radioactive materials that the RSO will use on the job. Additional formal training in radiation safety management, radiation dose assessment, and emergency response is desirable.

· Five years prior experience with radioactive material and devices. Professional experience must include managing and administering a radiation safety program related to the types, quantities, and uses of the radioactive materials that the applicant would use on the job. Prior experience as a names license or permit RSO is required.**

** Note: If contractor is unable to provide a RSO who was previously named as RSO on a license or VA permit, the contractor may be exempted from this requirement, upon receiving permission from VA NHPP program to do so, as long as other qualifications set forth herein are met.

The NHPP reviews qualifications: including the applicant RSO’s past performance on other licenses or permits. The review may include an interview with the RSO.

1. Continuing Education Units (CEU)/Continuing Medical Education (CME) hours-Requirements:

a. Contractor(s) shall provide the COR copies of current CMEs as required or requested by BCVA.

b. .Contractor(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. CME hours shall be reported to the credentials office for tracking. These documents are required for initial and renewal privileging. Failure to provide shall result in loss of privileges.

Training (CPRS and VA MANDATORY): Radiation Safety Officer/Medical Physicist shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contract providers as required by the VA.

NOTE: Medical Physicist must test all equipment. All other duties may be performed by either the Medical Physicist or RSO.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12.00
MO
__________________
__________________

RSO/Medical Physicist services in accordance with the Statement of Work.

Contract Period: Base POP Begin: 08-01-2021 POP End: 07-31-2022

1.00
JB
__________________
__________________

Annual compliance testing for ionizing x-ray and MRI requirement listed in SOW.

Contract Period: Base POP Begin: 08-01-2021 POP End: 07-31-2022

12.00
MO
__________________
__________________

RSO/Medical Physicist services in accordance with the Statement of Work.

Contract Period: Option 1 POP Begin: 08-01-2022 POP End: 07-31-2023

1.00
JB
__________________
__________________

Annual compliance testing for ionizing x-ray and MRI requirement listed in SOW.

Contract Period: Option 1 POP Begin: 08-01-2022 POP End: 07-31-2023

12.00
MO
__________________
__________________

RSO/Medical Physicist services in accordance with the Statement of Work.

Contract Period: Option 2 POP Begin: 08-01-2023 POP End: 07-31-2024

1.00
JB
__________________
__________________

Annual compliance testing for ionizing x-ray and MRI requirement listed in SOW.

Contract Period: Option 2 POP Begin: 08-01-2023 POP End: 07-31-2024

12.00
MO
__________________
__________________

RSO/Medical Physicist services in accordance with the Statement of Work.

Contract Period: Option 3 POP Begin: 08-01-2024 POP End: 07-31-2025

1.00
JB
__________________
__________________

Annual compliance testing for ionizing x-ray and MRI requirement listed in SOW.

Contract Period: Option 3 POP Begin: 08-01-2024 POP End: 07-31-2025

12.00
MO
__________________
__________________

RSO/Medical Physicist services in accordance with the Statement of Work.

Contract Period: Option 4 POP Begin: 08-01-2025 POP End: 07-31-2026

1.00
JB
__________________
__________________

Annual compliance testing for ionizing x-ray and MRI requirement listed in SOW.

Contract Period: Option 4 POP Begin: 08-01-2025 POP End: 07-31-2026

GRAND TOTAL
__________________

B.4 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 contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review…

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