36C26325Q0657_1.docx

SUBJECT*

Radiation Safety Officer FARGO VA Health Care System

GENERAL INFORMATION

SET-ASIDE

FARGO VA Health Care System

2101 Elm St North

Fargo North Dakota

COUNTRY

CONTACT INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 111 South 18th Plaza, Suite C151/152 Omaha NE 68102-2077

POINT OF CONTACT*

Contract Specialist Alberta Mickells Alberta.Mickells@va.gov 402-995-3081

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Presolicitation Notice

THIS IS A SOURCES SOUGHT NOTICE ONLY

The purpose of this Sources Sought is to conduct market research to determine small business sources capable of providing on-site annual, and as needed, performance evaluation of imaging equipment and Radiation Safety Officer (RSO) services at the FARGO VA Health Care System (SCVAHCS) and Community Based Outpatient Clinic (CBOC). Services per this notice under NAICS 541380 – Testing Laboratories and Services . Small Business Size Standard is $19 million.

****ANY INTERESTED VENDORS MUST BE ABLE TO BE ON SITE IN 2 HOURS*****

BACKGROUND:

THIS IS A SOURCES SOUGHT NOTICE BEING RELEASED PURSUANT TO FEDERAL ACQUISITION REGULATION (FAR) PART 10: MARKET RESEARCH.

This notice is issued solely for informational, market research, and planning purposes only. It does not constitute a solicitation or a promise to issue a solicitation in the future. This notice does not commit the Federal Government to contract for any service at this time.

Further, the U.S. Department of Veterans Affairs, Network Contracting Office (NCO) 23 is not at this time seeking offers and will not accept unsolicited offers.

Respondents are advised that the Federal Government will not pay for any information or administrative costs incurred in response to this notice. All costs associated with responding to this notice will be solely at the responding party’s expense.

Responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Although the term “offeror” is used in this notice, your respective organization’s response will be treated as information only and shall not be used as an offer.

OBJECTIVE:

This Sources Sought is to gain knowledge of potential qualified sources and their size classification(s) (Service Disabled/Veteran Owned Small Business (SD/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, or large business) relative to NAICS 541690.

DESCRIPTION OF SERVICE:

Please see attached DRAFT - Statement of Work for full description of this service request.

The contractor shall provide a board Certified or board eligible Medical or Health Physicist to provide routine daily virtual, quarterly onsite coverage and on-site emergency coverage Radiation Safety Officer (RSO) services for the Fargo VA Health Care System (FVHCS), 365 days year, 24-hour coverage, and mileage, per diem and travel expenses should be included in all services solicitation. The FVHCS includes Fargo Medical Center and Community-Based Outpatient Clinics (CBOC) in Minnesota, and North Dakota which have imaging services. Radiation Materials Licensing experience is a requirement. The Contractor shall furnish personnel to provide Radiation Safety Officer Duties to fulfill the Radiation Materials Licensing requirement as specified by the National Health Physics Program (NHPP). The contractor’s personnel serve as the RSO for the organization and for the comprehensive Radiation Safety Program for the Fargo VA Health Care System in Fargo ND. The FVAHCS makes extensive use of ionizing radiation and radioisotope material in the diagnosis and treatment of disease in the veteran population.

The FVAHCS makes extensive use of ionizing radiation and radioisotope material in the diagnosis and treatment of disease in the veteran population.

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO). Please See attached Directive 1105 .04

PLACES OF PERFORMANCE:

Fargo VA Health Care System 2101 Elm Street North Fargo, ND 58102-2417

Grand Forks, ND, CBOC 3221 32nd Avenue South, Suite 700 Grand Forks, ND 58201-6075

Bismarck, ND, CBOC 2700 State Street, Gateway Mall, Suite F Bismarck, ND 58503-0669

Fergus Falls, MN, CBOC 1839 North Park Street Fergus Falls, MN 56537-1247

Bemidji, MN, CBOC 1217 Anne Street NW Bemidji, MN 56601-5113

POTENTIAL SCOPE OF WORK:

Please see attached DRAFT Statement of Work

CERTIFICATIONS AND LICENSURE:

See Statement of Work

RESPONSE TO SOURCES SOUGHT

Offerors shall submit a capability statement indicating their ability and experience to provide the services cited above; such statement shall also list:

· Company Name:

· Point of Contact (POC) name:

· Email address:

· Phone number:

· Unique Entity ID No. listed in the System of Awards Management (SAM):

· Business Size: (Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Small Business Other, Small Business, or Large Business) for the NAICS code 541380.

• Please indicate whether you hold a GSA Federal-Supply-Schedule or Indefinite Delivery/Indefinitely Quantity (IDIQ) contract that covers this type of request. If so, please provide the Schedule contract number.

SUBMITTAL OF RESPONSES:

No phone calls please. Send any responses by e-mail only. As this is a Sources Sought Notice for market research purposes, the Government will not accept any technical questions at this time.

Responses shall be sent via electronic mail only by 04/22/2025 at 10:00AM Central Standared time to:

Alberta Mickells Contracting Specialist E-mail: Alberta.Mickells@va.gov

STATEMENT OF WORK

Board Certified or Board Eligible Medical Radiation Safety Officer Fargo VA Healthcare System

1. BACKGROUND.

The contractor shall provide a board Certified or board eligible Medical or Health Physicist to provide routine daily virtual, quarterly onsite coverage and on-site emergency coverage Radiation Safety Officer (RSO) services for the Fargo VA Health Care System (FVHCS), 365 days year, 24-hour coverage, and mileage, per diem and travel expenses should be included in all services solicitation. The FVHCS includes Fargo Medical Center and Community-Based Outpatient Clinics (CBOC) in Minnesota, and North Dakota which have imaging services. Radiation Materials Licensing experience is a requirement. The Contractor shall furnish personnel to provide Radiation Safety Officer Duties to fulfill the Radiation Materials Licensing requirement as specified by the National Health Physics Program (NHPP). The contractor’s personnel serve as the RSO for the organization and for the comprehensive Radiation Safety Program for the Fargo VA Health Care System in Fargo ND. The FVAHCS makes extensive use of ionizing radiation and radioisotope material in the diagnosis and treatment of disease in the veteran population.

The FVAHCS makes extensive use of ionizing radiation and radioisotope material in the diagnosis and treatment of disease in the veteran population.

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO). Please See attached Directive 1105 .04

2. OBJECTIVES.

The FVHCS is seeking a solution to provide Radiation Safety Officer to fulfill the Radiation Materials Licensing requirement as specified by the National Health Physics Program (NHPP). The contractor’s personnel serve as the RSO for the organization and is a major component for the comprehensive Radiation Safety Program for the Fargo VA Health Care System.

RSO must perform routine work : radiation safety surveys within FVAHCS facilities for the safe and effective use of these modalities are established by the Nuclear Regulatory Commission (NRC) (e.g., 10 CFR 19, 20, 30, and 35, among others), Occupational Health and Safety Administration (OSHA), Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Transportation (DOT), Veterans Health Administration (VHA), Joint Commission, and Officer Inspector General. The RSO must provide oversite to the Radiation Physics program and Nuclear Medicine Department. The RSO provides emergency consultation in response to a facility Emergency Disaster or Radiologic Emergency event.

The RSO helps manage U.S. Nuclear Regulatory (NRC)/VHA Materials Permit as amended for receipt, location, possession, use, storage, and transfer of radioactive material. Preparing Permit applications, amendments, correspondence, and timely responses for signature to NRC and VHA-NHPP as needed, in accordance with all regulations.

The RSO helps facilitate dosimetry program for a National Voluntary Laboratory Accreditation Program (NVLAP) certified vendor for occupational exposure to ionizing radiation including monthly additions, collection, evaluation, reporting, distribution, and deletion of personal monitoring devices. The RSO is involved with the oversight of the personnel monitoring program and eliminating/reducing or controlling exposure to radiation hazards.

The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide RSO medical physics services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must adhere to VHA Handbook 1105.04, Fluoroscopy Safety, dated June 21,2018, 1105.02, 1105 or current version.

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO). Please See attached Directive 1105 .04

3. QUALIFIED PERSONNEL: All Radiation Physicists performing RSO services under this contract shall work under a board certified Medical/Health Physicist from one of the following boards: American Board of Radiology, American Board of Health Physicists or American Board of Medical Physicists or Canadian College of Physicist in Medicine. Candidate can either be master’s Level or PhD. The Contractor must meet state licensure to practice as medical health physicist, and or Radiation Safety Officer and have membership (or eligibility for membership) to the American Association of Physicists in Medicine (AAPM). The Proposed Physicist must have minimum qualification requirements in Title 10, Part 35.50, of the Code of Federal Regulations (10 CFR 35) and must have at least 5 years of RSO experience and working with radiation materials The RSO must also be approved by a permit amendment from the VHA National Health Physics Program (NHPP). Board-eligibility must be maintained throughout the contract period of performance. All continuing education courses required for maintaining certification/eligibility must be current. Documentation verifying current licensure and certifications must be provided quarterly, or as requested, to ensure adequate licensure and certification status.

Personnel must also have experience in Hospital Medical Physics and be familiar, experience with state regulations (North Dakota, Minnesota), and VA regulations. The personnel will be identified in the proposal and shall be considered key personnel as essential for the successful completion of the work performed. Any changes to the assignment of personnel must be communicated to the Contracting Officer Representative (COR) and Imaging Supervisor at least 5 days before new personnel will visit the FVHCS. Proposed Physicist must be approved by the National Health Physics Program (NHPP) program to function as a Radiation Safety Officer (RSO) on the FVHCS Radiation Materials License.

The Contractor shall provide personnel qualified and licensed as a Radiation Safety Officer and Associate Radiation Safety Officer if warranted and approved by the NHPP. Qualifications for all responsible personnel shall meet the requirements of under 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.13, 10 CFR 35.14, 10 CFR 35.24, 10 CFR 35.50, 10 CFR 35.57, and 10 CFR 35.59.

The Contractor shall provide personnel who is fully recognized and approved by the United States Nuclear Regulatory Commission (U.S. NRC).

Following contract award, the contractor shall be required to initiate measures for assigned personnel to be added to Fargo VA Materials Permit as Radiation Safety Officer within thirty calendar days. Contractor assigned RSO(s) shall conduct training of VA staff assigned with assisting Radiation Safety measures as required.

Technical Proficiency - Contractor’s physicist(s) shall be technically proficient in medical health physics, and Radiation Safety Officer. Personnel must also have Radiation safety officer experience in Hospital Medical Physics and be familiar with North Dakota, Minnesota, and VA regulations. The personnel will be identified in the proposal and shall be considered key personnel as essential for the successful completion of the work performed. Any changes to the assignment of personnel must be communicated to the Contracting Officer’s Representative (COR) and Imaging Supervisor at least 20 days before new personnel will visit the FVAHCS. Completion of training in Regulatory and Safety compliance in Nuclear Medicine.

LAWS, PERMITS AND LICENSES: Services performed as part of this PWS, and contract must be in accordance with all applicable laws, ordinances, regulations, and service requirements as enforced by Federal, state, local and industry. The Contractor shall be following US NRC, to include obtaining and maintaining all required licenses and permits required by Federal, state, local and industry laws. Contractor is required to coordinate and support Fargo VAMC Director in maintaining a current RSO Permit, as approved by NHPP, for the Fargo VA Medical Center. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physicist (s) {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

INFLUENZA: Contractors shall provide proof that all Contractor physicists have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physicist has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician (s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

Conflict of Interest: The Contractor and all Contractor’s physicist(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

Citizenship related Requirements:

The Contractor certifies that the Contractor shall comply with all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract, or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, because of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1105. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract will be provided by the Imaging Supervisor, Imaging ACOS or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

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

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

Inherent Government Functions: Contractor and Contractor’s physicist shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

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

Tort Liability: Any settlement or judgment arising from a Contractor’s action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

Key Personnel:

The VA Full Time Equivalency (FTE) for the services required is 1.0 FTE. FTE is defined by VA as a minimum of 40 hours every two weeks and does not include holidays.

The minimum number of Board-Certified physicists required to provide coverage daily is 1 as defined in paragraph Hours of Operation in this section.

The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations, and additional coverage as required. In the event a scheduled physicist is unable to complete an assigned shift, the contractor shall provide replacement physicist coverage within 2 hours and notify the Contracting Office Representative (COR) at the Fargo VA Health Care System immediately of the schedule change.

Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar day (s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

For temporary substitutions where the key person shall not be reporting to work for three 3 consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA Imaging COS, supervisor or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s physicist (s), s/he may request, without cause, immediate replacement of said Contractor’s physicist (s). The CO and COR shall deal with issues raised concerning Contractor’s physicist (s) conduct. The final arbiter on questions of acceptability is the CO.

Contingency Plan: Because continuity of care and requirements of radioisotope licensure requirements as described in VHA Directive 1105 and 1129, it is an essential part of FVAHCS medical services, the Contractor shall have a contingency plan in place to be utilized if the Contractor’s physicist (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

Change of times or dates of survey visits must be coordinated with the Imaging department at least two weeks in advance.

Provide written report of completed audits/surveys to Imaging Supervisor or designee within thirty (30) working days of performance of the survey.

4. POLICY/HANDBOOKS. The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide Radiation Safety Officer services for FVAHCS, under the terms and conditions stated herein and must adhere to following directives/regulations/requirements by regulatory and accreditation bodies:

· VHA Directive 1105 - Management of Radioactive Materials https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3080

· VHA Directive 1105.02 Nuclear Medicine and Radiation Safety Administrative Service https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7519

· VHA Handbook Directive 1105.04 - Fluoroscopy Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7454

· VHA Directive 1105.05 - Magnetic Resonance (MR) Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6430

· VHA Directive 1129 – Radiation Protection for Machine Sources of Ionizing Radiation https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8273

· VHA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

· VHA Handbook 1907.01: Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

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

· VHA Directive 1004.08 Disclosure of Adverse Events to Patients and local Emergency, Radiation Disaster policies. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8120

· 10 CFR 35. 3045 Report and Notification of a medical of a medical event https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-3045.html

· 10 CFR 35.24 NRC Authority and responsibilities for the radiation protection program https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0024.html

· VHA Directive 0320 VHA Comprehensive Medical Emergency Radiological Response Team Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8906

· VHA Directive 0320.05, Medical Emergency Radiological Response Team https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8425

· 10 CFR 30.6 Communications NRC: https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0006.html

· American College of Radiology Disaster preparedness for Radiology Professionals https://www.acr.org/-/media/ACR/Files/Legal-and-Business-Practices/Disaster-Preparedness/Disaster-Preparedness-for-Radiology-Professionals.pdf

· U. S. Department of Health and Human Services: https://www.remm.nlm.gov/

· 10 CFR 30.50 Reporting Requirements NRC. https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

· 10 CFR 30.50 Reporting Requirements NRC. https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

5. DEFINITIONS/ACRONYMS. Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

· Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

· Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

· Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is in Washington, D.C.

· Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

· COS: Chief of Staff

· CPARS: Contractor Performance Assessment Reporting System

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

· HIPAA: Health Insurance Portability and Accountability Act

· ISO: Information Security Officer

· POP: Period of Performance

· PWS: Performance Work Statement

· QA/QI: Quality Assurance/Quality Improvement

· QM/PI: Quality Management/Performance Improvement

· QASP: Quality Assurance Surveillance Plan

· ABHP: American Board of Health Physics

· ABRB: American Board of Radiology

· ACR: American College of Radiology

· ALARA: As Low as Reasonable Achievement

· ADP: Automated Data Processing

· AMA: American Medical Association

· CQI: Continuous Quality Improvement

· ISO: Information Security Officer

· JCAHO: Joint Commission on Accreditation of Healthcare Organizations

· NCQA: National Committee for Quality Assurance

· NRC: Nuclear Regulatory Commission

· OSHA: Occupational Safety and Health Administration

· PO: Privacy Officer

· PO: Purchase Order

· QA: Quality Assurance

· QI: Quality Improvement

· RSO: Radiation Safety Officer

· SDB: Small Disadvantaged Business

· USC: United States Code

· VA: Department of Veterans Affairs

· VA NHPP: VA National Health Physics Program

· VISN: Veterans Integrated Service Network

· VISTA: Veterans Health Information Systems & Technology Architecture

6. SCOPE OF WORK:

a. The contractor shall furnish all labor, material, supplies, carry equipment onsite, and qualified personnel to provide Radiation Safety Officer services at the Fargo VA Health Care System (Fargo Medical Center), and CBOC’s if applicable, in accordance with the terms and conditions stated herein. VA may increase the number of clinics under this contract at no change to the contract price schedule for up to 2 additional sites per option year. If additional clinical sites beyond these additional sites require the contract a modification and will be negotiated at that time.

b. RSO must perform routine work using a combination of onsite and virtual services : quarterly radiation safety audits (onsite) at FVAHCS facilities for the safe and effective use of these modalities are established by the National Health Physics Program (NHPP), Nuclear Regulatory Commission (NRC) 10 CFR 19, 20, 30, and 35, among others, Occupational Health and Safety Administration (OSHA), Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Transportation (DOT), Veterans Health Administration (VHA), Joint Commission, and Officer Inspector General, American College of Radiology (ACR). The onsite observation of radiation safety practices with real time visualization. The RSO must help provide oversite to the Radiation Physics program and Nuclear Medicine Department. The RSO provides emergency consultation in response to a facility Emergency Disaster or Radiologic Emergency event. Policy reviews may be provided via electronic means and submitted for recommendation. Radioisotope materials licensing experience is a requirement.

c. The RSO must help provide oversite to the Radiation Physics program and Nuclear Medicine Department using a combination of onsite and virtual services. The RSO provides emergency consultation in response to a facility Emergency Disaster or Radiologic Emergency event. Policy reviews may be provided via electronic means and submitted for recommendation. Radioisotope materials licensing experience is a requirement.

d. The RSO shall help maintain oversight of radioactive material within the Radiation Safety Program, where responsibilities include, but are not limited to the following:

1. Ensuring safe use of radioactive materials and regulatory compliance along with the VA medical facility Director as well as the VA medical facility Radiation Safety Committee.

2. Completing day to day actions required by NRC regulations, for the VA medical facility’s radioactive materials permit, which include, but are not limited to, the tasks and actions described in Appendix A of VHA Directive 1105 as well as NRC NUREG-1556, Vol. 9, Rev.3 and NUREG 1556 Vol. 11, Rev. 1.

3. Performing periodic audits and surveys of services and sections using radioactive materials and reporting results to the Radiation Safety Committee (RSC).

4. Investigate overexposures, accidents, isotope spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, medical events, and other deviations from approved radiation safety practice and implement corrective actions as necessary.

e. The RSO provides oversite of Radiation Program by Medical Physicist/Radiation safety officer: Manage U.S. Nuclear Regulatory (NRC)/VHA Materials Permit as amended for receipt, location, possession, use, storage, and transfer of radioactive material. Preparing Permit applications, amendments, correspondence, and timely responses for signature to NRC and VHA-NHPP as needed, in accordance with all regulations.

f. Facilitates dosimetry program for a National Voluntary Laboratory Accreditation Program (NVLAP) certified vendor for occupational exposure to ionizing radiation including monthly additions, collection, evaluation, reporting, distribution, and deletion of personal monitoring devices. Provides oversight of the personnel monitoring program and eliminating/reducing or controlling exposure to radiation hazards.

g. RSO must perform radiation safety surveys within FVHCS facilities to ensure compliance with the current American College of Radiology (ACR) and National Health Physics Program (NHPP) as required.

h. The position sensitivity has been designated as low sensitivity. The level of background investigation is a National Agency Check with Written Inquiries. The level of risk associated with the contracted employee position is equivalent to the level required of a VA Employee working in such a position. Note: Level of Risk must be determined by the Information Security Officer (ISO) prior to submitting required investigations.

i. Contractor staff performing RSO duties will complete and sign VA’s national Rules of Behavior and Privacy Policy training prior to performing inspection.

j. Vendor must have the ability to be at facility, or at VA community site for emergency radiation services within several hours of call requesting services.

k. Subcontracting of services will not be allowed due to the emergent need to provide emergent RSO services when it goes down for the interventional radiology equipment.

7. RADIATION SAFETY OFFICER

a. QUALITY CONTROL: Work performed under this contract shall be subject to evaluation by the Contract Officers Representative (COR) in accordance with the contract terms and conditions.

b. PLACE OF PERFORMANCE: Fargo VA HCS (Fargo Veteran Affairs Medical Center, 2101 North Elm Street, Fargo, ND 58103, Bismarck North Dakota CBOC, Bemidji Minnesota, CBOC, Grand Forks North Dakota CBOC, Fergus Falls Minnesota, CBOC.

c. EQUIPMENT. Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site RSO services at the Fargo VHCS (Fargo Medical Center, and CBOC’s) in accordance with the terms and conditions stated herein. The FVHC will provide a person to be present during the inspection.

TRAVEL: Travel expenses, per diem, will be covered under the contract.

1. HOURS:

VA Business Hours regular administrative working hours: 8:00 am – 5:00 pm Monday through Friday, excluding Federal Holidays. There may be times when the Contractor could be needed to work after regular working hours. Routine coverage of RSO can be provided virtual, with the exceptions stated in this statement of work.

Provision of 24 hours a day, 7 days week service using combination of virtual and onsite services.

The certified Health Physicist or Medical Physicist and (Radiation safety officer) shall respond to emergency situations within one (1) hour by phone and on-site and within 2 hours based on severity of the event or disaster to accomplish the radiation safety services, testing of medical equipment including non-emergent work. For non-emergency situations with 8 hours when notified by the VA COR, Imaging Supervisor, Chief or VA designee(s).

10 CFR 30.50 Reporting Requirements NRC.

https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

FEDERAL HOLIDAYS: The holidays observed by the Federal Government are:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Juneteenth

· Any other day specifically declared by the President of the United States to be a Federal Holiday

GENERAL PROVISIONS.

Services will be provided at the Fargo VA Health Care System (Medical Center 2101 N Elm Street Fargo, ND, Grand Forks, ND, CBOC, Bismarck, ND, CBOC, Fergus Falls, MN, CBOC, Bemidji, MN, CBOC. Services will be provided at during the hours of 8:00am – 5:00pm, Monday through Friday, excluding Federal Holidays. Inspection dates and times will be mutually agreed upon and established. Policy reviews may be provided via electronic means and submitted for recommendation. Fargo VAHCS will provide a qualified person to operate the equipment and be present during the inspection. VA may, from time to time, make changes to the Scope of Work under this Contract, through a written modification. A modification shall not modify the overall purpose of this Contract.

Contractor staff performing inspection will be subject to a background investigation and receive a favorable adjudication from the VA Security Center (VSC). If security clearance is not completed prior to the start of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform services for the VAHCS.

The position sensitivity has been designated as low sensitivity. The level of background investigation is a National Agency Check with Written Inquiries. The level of risk associated with the contracted employee position is equivalent to the level required of a VA Employee working in such a position.

Contractor staff performing inspections will complete and sign VA’s National Rules of Behavior and Privacy Policy training prior to performing inspections.

and submitted for recommendation. Fargo VAHCS will provide a qualified person to operate the equipment and be present during the inspection. VA may, from time to time, make changes to the Scope of Work under this Contract, through a written modification. A modification shall not modify the overall purpose of this Contract.

Change of times or dates of survey visits must be coordinated with the department at least two (2) weeks in advance.

Contractor staff performing inspection will be subject to a background investigation and receive a favorable adjudication from the VA Security Center (VSC). If security clearance is not completed prior to the start of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform services for the VAHCS.

The position sensitivity has been designated as low sensitivity. The level of background investigation is a National Agency Check with Written Inquiries. The level of risk associated with the contracted employee position is equivalent to the level required of a VA Employee working in such a position.

Contractor staff performing inspections will complete and sign VA’s National Rules of Behavior and Privacy Policy training prior to performing inspections.

Contractor will provide equipment calibration records for all equipment used to test equipment.

VA may increase the number of equipment items or test covered under this contract at no change to the applicable contract price schedule.

VA may add additional CBOC sites for testing when imaging service is implemented with a modification to the current contract.

The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA Imaging COS, supervisor or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s physicist (s), s/he may request, without cause, immediate replacement of said Contractor’s physicist (s). The CO and COR shall deal with issues raised concerning Contractor’s physicist (s) conduct. The final arbiter on questions of acceptability is the CO.

CONTRACTOR RESPONSIBILITIES:

Clinical Personnel Required:

The Contractor shall provide Contractor’s physicist(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties. Standards of Scope of Practice and RSO duties:

The Contractor’s physicist(s)’ care shall cover the range medical physicist services scope of practice as outline by the American Association of Physicist in Medicine (AAPM). The essential responsibility of the Qualified Medical Physicist's clinical practice is to assure the safe and effective delivery of radiation to achieve a diagnostic or therapeutic result as prescribed in patient care. The medical physicist performs or supervises the technical aspects of procedures necessary to achieve this objective.

HEALTH PHYSICS INSTRUMENTATION REQUIREMENTS

The RSO(s) shall provide the following services, and report as necessary to BIOMED for tracking of instrument calibration:

A. Calibration of instruments used for performing ambient dose rate surveys which includes calibration in dose rate (e.g., R/hr) and/or count rate (e.g., cpm) as needed, required by regulation, or deemed appropriate by a qualified expert.

B. Calibration of instruments used for direct measurement of radiopharmaceuticals as needed, required by regulation, or deemed appropriate by a qualified expert. Radioactive calibration sources shall be provided by Fargo, however, all written procedures for completing such calibrations as well as knowledge and expertise shall be provided by the RSO(s).

C. Calibration of instruments used for the detection and quantification of removable radioactive contamination. Required calculations include but are not limited to; lower level of detectability (LLD), minimum detectable activity (MDA), detector efficiencies for all photon energies applicable to Fargo VA. Sealed radioactive sources shall be provided by Fargo VA, however, all written procedures for completing such calibrations as well as knowledge and expertise shall be provided by the RSO(s).

D. Perform an annual review and summary of the Radiation Safety Program involving by-product material and will present the summary to the Radiation Safety Committee.

Standards of Scope of Practice, duties, responsibilities:

The Contractor’s physicist(s)’ care shall cover the range medical physicist services scope of practice as outline by the American Association of Physicist in Medicine (AAPM). The essential responsibility of the Qualified Medical Physicist's clinical practice is to assure the safe and effective delivery of radiation to achieve a diagnostic or therapeutic result as prescribed in patient care. The medical physicist performs or supervises the technical aspects of procedures necessary to achieve this objective.

The standard of practice shall be of a quality, meeting or exceeding current recognized national standards as established by:

The requirements contained in this PWS regarding RSO responsibilities and providing oversite: Implement and oversee the operational aspects of the Radiation Protection Program (RPP).

Ensure (for the licensee) that radiation safety activities, procedures and policies are being performed in accordance with federal and state regulations.

Ensure quality control programs are working effectively and follow the local, state, national regulations.

Ensure local guidelines and policies for the safe, effective use of these modalities are established by the Health Care System’s Radiation Safety Committee and the RSO. Review and approve (with licensee management) RPP changes before implementation.

Help identify and investigate radiation safety problems and initiate, recommend, or provide corrective actions for identified safety problems. Verify implementation of corrective actions and stop operations identified as unsafe.

Notify management of radiation safety problems, unsafe operations, and corrective actions.

Perform as a liaison between the RSC and the users of ionizing radiation and Function as a liaison between the licensee (FVAHCS) and the regulatory agencies.

Sign semiannual sealed-source leak tests and inventories of sealed sources per regulation.

Attend Quarterly Radiation Safety Committee meetings; ensuring that appropriate documentation is executed and available. RSO will provide a summary of major activities/tasks performed, including recommended corrective actions and consultations.

Provide Emergency Disaster coverage to the local facility regarding Radiologic events.

Inventory radioactive material, survey meters fixed/portable diagnostic & therapeutic x-ray devices and ensures that quality controls are implemented including periodic surveys for exposure, calibration, linearity studies, sealed source leak testing, safety equipment, storage, and timely removal of contamination.

Coordinate with the FVAHCS contracted radiation physics group to assure annual hazard testing, and newly installed equipment and shielding acceptance testing is performed. This includes review of testing results and implementation of any corrections and/or recommendations.

Manage U.S. Nuclear Regulatory (NRC)/VHA Materials Permit as amended for receipt, location, possession, use, storage, and transfer of radioactive material. Preparing Permit applications, amendments, correspondence, and timely responses for signature to NRC and VHA-NHPP as needed, in accordance with all regulations.

Facilitates dosimetry program for a…