United States - H--36C26319Q0671 Radiation Safety Officer VAMC FARGO, ND

Description

Added: Jun 10, 2019 4:24 pm

SOURCES SOUGHT NOTICE

The Department of Veterans Affairs is seeking interested sources for the below listed requirement. The performance location will be at the Fargo, ND VAMC.

This sources-sought announcement is a tool to identify concerns with the capability to accomplish the work. This is not a solicitation.

Please provide the following to Mr. Stephen Holly via email to Stephen.holly@va.gov.

A capability statement expressing interest in this requirement, describing your company and its capability to complete this work. Include a statement detailing any special qualifications and certifications, applicable to the scope of this project, held by your firm and/or in-house personnel. Please indicate your business concern status, large business, small business, SDVOSB/VOSB.

The requirement consists of the following draft Statement of Work:

STATEMENT OF WORK

RADIATION SAFETY OFFICER

BACKGROUND:

The service of a Certified Medical or Health Physicist to provide on-site Radiation Safety Officer (RSO) Duties for the VA Fargo Health Care System (FVAHCS) at Fargo, North Dakota is a Radiation Materials Licensing requirement.

The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide Radiation Safety Officer 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.

OBJECTIVES:

The FVAHCS is seeking a solution to provide Radiation Safety Officer Duties to fulfill the Radiation Materials Licensing requirement as specified by the National Health Physics Program (NHPP). The incumbent serves as the RSO for the organization and is responsible for the comprehensive Radiation Safety Program for the Fargo VA Health Care System, Fargo ND. The FVAHCS makes extensive use of ionizing radiation in both diagnosis and treatment of disease in the veteran population.

QUALIFIED PERSONNEL:

All Radiation Physicists performing services under this contract shall be board certified or board eligible from one of the following boards: American Board of Radiology, American Board of Health Physicists or American Board of Medical Physicists. Certification must be maintained throughout the contract performance period. Personnel must also have 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 Representative (COR) and Imaging Supervisor at least 5 days before new personnel will visit the FVAHCS.

The Proposed Physicist must be approved by the NHPP program to function as a RSO on the FVAHCS Radiation Materials License. The Proposed Physicist must have minimum qualification requirements in Title 10, Part 35, of the Code of Federal Regulations (10 CFR 35). The RSO must also be approved by a permit amendment from the VHA National Health Physics Program (NHPP).

SCOPE OF WORK:

RSO must perform 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.

RSO RESPONSIBILITIES:

The RSO is responsible to:

Implement and oversee the operational aspects of the Radiation Protection Program (RPP)

Ensure (for the licensee) that radiation safety activities are being performed in accordance with

Licensee approved procedures and regulatory requirements

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

Initiate, recommend, or provide corrective actions for identified safety problems

Verify implementation of corrective actions

Stop operations identified as unsafe

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

Attend Radiation Safety Committee (RSC) meetings and make recommendations if needed

Provide a link between the RSC and the users of ionizing radiation

Provide the contact between the licensee and the regulatory agencies

Be available for contact by facility staff per regulations and license conditions

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

Quarterly Radiation Safety Committee meeting attendance; 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 Oversite

inventory of 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.

communicate with the facility ACOS for Imaging, Imaging Supervisor, and RSO Assistant

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.

Facility dosimetry program from 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.

Policies and procedures for the safe use of radioactive material in restricted areas including baseline, equipment, training, surveys, and close-out of restricted areas in Medical Research, Nuclear Medicine, and Nursing Services for use of therapeutic administration of radiopharmaceuticals requiring a written directive.

instruction and consultation to personnel in Nuclear Medicine, Imaging, and support services who work or frequent nearby restricted areas where ionizing radiation, radiopharmaceuticals, or use of radioactive materials is authorized.

Conduct onsite Annual Imaging Audits of the Imaging department: general x-ray, dexa, CT, Nuclear medicine to include the VA radiation audit for quality control, and quality assurance

RSO DUTY SPECIFICTIONS

Action or Trigger Levels

Establish investigation levels for:

Personnel exposures

Area surveys: dose rate and contamination

Types and amounts of radioactivity are secure from unauthorized user or misappropriation and can be readily accounted for.

As Low as Reasonably Achievable (ALARA)

Enforce the ALARA regulatory/license requirements

Inform/instruct workers of licensee/management commitment to ALARA

Investigate deviations from ALARA practices for cause, and implement changes

Audits/Reports/Reviews

Review (at least annually) the RPP content and implementation with management

Onsite Annual Imaging Audits of the Imaging department: general x-ray, dexa, CT, Nuclear medicine to include the VA radiation audit for quality control, and quality assurance

Audit (at least semiannually) the RPP and the ALARA program; document and report results to

management

Review (quarterly) occupational doses and prepares a summary report including individuals

exceeding trigger levels and regulatory limits

Review doses to members of the public and prepare a summary report

Review (quarterly) dose rate and contamination survey results and prepare a summary report

Audit (at least annually) the adequacy of procedures for preventing medical events; including,

written directive compliance and patient identification for Nuclear Medicine, and entire Imaging department.

Review incidents involving ionizing radiation with respect to cause and subsequent actions

taken

Report incidents as required by regulation, including:

Doses, radiation levels, or concentrations of radioactive materials exceeding a constraint or

limit individuals of exceeding the regulatory dose limits

Leaking source

Report and notification of a medical event per regulation

Report and notification of an unintended dose to an embryo/fetus or a nursing child that

exceeds the regulatory limits

Theft or loss of licensed materials

Annually review and update of the EPA s National Emission Standards for Hazardous Air Pollutants (NESHAPs), if required.

Annually review and update of the Fluoroscopy Safety Program including ALARA, shielding surveys, inventories, and equipment, calibration, and performance testing, quality management

Program; policies, procedure and written directives

Annually review and update of OIG checklist on quality control, quality assurance

Annual onsite safety audit of surgery department radiation practices

Attend quarterly Radiation Safety meetings

Review quarterly MRI quality control documents and sign

Contamination/Spill/Response

Establish a procedure for spill response in the RPP, including:

Liquid spills

Gas and aerosol releases

Establish a procedure for skin and another surface decontamination

Train workers in spill response and decontamination techniques

Estimate skin/organ dose

Facility Designation, Design, and Shielding

Identify addresses and areas of use

Identify restricted, unrestricted, and controlled areas

Consult on facility design and shielding

Instruction of Workers

Instruct workers likely to receive >100 mRem/year

Provide radiation safety instruction to personnel caring for radiopharmaceutical patients per

Regulation

Provide review and summary of the radiation safety program and summary to the Radiation Safety Committee.

Provide Annual Radiation safety training, which includes a radiation safety PowerPoint, and test for staff and personnel commensurate with risk of exposure to ionizing radiation from use of fluoroscopy, radioactive material, or x-rays covering the local, state, and federal regulations

Instruct supervised staff in radiation protection and radiation protection revisions before implementation, including:

Individuals of exceeding the regulatory dose limits

Leaking source

Report and notification of a medical event per regulation

Report and notification of an unintended dose to an embryo/fetus or a nursing child that

exceeds the regulatory limits

Theft or loss of licensed materials

Operating procedures

Department of Transportation (DOT) training

Declared Pregnant Woman (DPW) regulations

Notification of RSO

Regulations and license conditions

Written directive procedures

Where do I wear my radiation badge training

Maintain a current license, submit amendment, and renewal requests in a timely manner

Develop, distribute, and implement up-to-date RPP procedures

Assure that the possession, use, and storage of byproduct material is consistent with the

regulations, the license conditions, the Sealed Source and Device Registry (SSDR)

certificate(s), and any manufacturer s recommendations and instructions

Machine Registration/Calibration

Maintain current machine registrations

Assure that calibration and testing are performed per regulations and/or license conditions and

according to professional standards of good practice

Medical Events

Maintain written procedures to prevent medical and other addressable

events

Investigate medical events as to cause(s); identify and take timely, appropriate corrective

action(s)

Report medical events to management and to regulatory authorities per regulations

overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals,

medical events and other deviations from approved radiation safety practice, report event to the

appropriate authorities, and implement corrective

Ordering/Receiving/Transporting Packages Containing Radioactive Material

All orders authorized by the RSO, RSO designee, or authorized user

Receipt address and area of use approved by the RSO

Packages properly secured when not attended

Packages received, surveyed, swiped, and processed per regulations and license conditions

Licensed material is transported, or offered for transport, in accordance with all applicable

DOT requirements

Patient Protection

Establish dose calibrator calibration and quality control procedures per regulations

Perform dose calibrator calibration and quality control procedures

Establish prescribed dosage list (AU approved)

Assay and record patient dosages

Enforce policy for identifying pregnant patients

Perform fetal dose measurements/estimations

Release per approved criteria/regulations

Radiation safety instructions provided

Personnel Monitoring

Establish a system to ensure that monitors are worn and returned in a timely manner, including:

Advise on who and when individuals should be monitored

Advise on where and how personnel monitoring devices shall be worn

Enforce the use of personnel monitoring devices

Personnel Monitoring

Establish a bioassay program consistent with regulatory requirements and use

Perform and record bioassay measurements

Interpret the results of personnel monitoring and bioassay measurements

Advise the staff of their personnel monitoring and bioassay results

Investigate doses exceeding trigger levels as to cause

Provide annual written reports to badge wearing staff

Provide written dose reports to staff who are separated from the facility

Post/Reference Documents and Notices

Post or reference:

Applicable rules or regulations

License, license conditions, documents incorporated into the license by reference, and

amendments

Operating procedures applicable to license activities

Post Notices of radiation effects in Imaging department

Notice to Employees

Any notice of violation, proposed imposition of civil penalty or order, and any licensee

response

Posting and Labeling

Post or label:

Doors and/or rooms and areas

Containers, syringes, or syringe shields

Emergency liquid spill procedures

Emergency Tc-99m aerosol spill procedures

Pregnant Workers

Review previous occupational doses

Advise worker on dose reduction

Discuss Declared Pregnant Woman (DPW) status

Monitor monthly doses

Modify DPW job functions as necessary to keep conceptus dose below regulatory limit

Sealed-Source Leak Test and Inventory

Perform semiannual sealed-source leak tests

Perform semiannual sealed-source inventories

Radiation Accidents

Attend institution s radiation accident committee and advise as necessary

Advise on the design of the radiation accident response plan

Assist in the response to radiological accidents or emergencies

RECORDS MANAGEMENT OBLIGATIONS

A.  Applicability

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

B.  Definitions

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

The term Federal record:

Includes Fargo VA Health Care System records. 

Does not include personal materials.

Applies to records created, received, or maintained by Contractors pursuant to their Fargo Health Care System contract.

May include deliverables and documentation associated with deliverables.

C.  Requirements

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

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

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

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

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

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

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Fargo Health Care System policy. 

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

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

 

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

11. Training.  All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to Fargo Health Care System policies, including initial training and any annual or refresher training. 

[Note: To the extent Fargo Health Care System requires contractors to complete records management training, the Fargo Health Care System must provide the training to the contractor.] 

D.  Flow down of Requirements to Subcontractors

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

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

Surveys and Survey Instruments

Surveys for ambient radiation exposure rate

Surveys for fixed and removable contamination

Surveys after source implant and removal

Surveys of therapeutic treatment units

Radiation survey instrument calibrations

Waste Disposal

Return to supplier

Transfer to authorized recipient

Disposal-by-decay the sealed source inventory greater than 1 millicurie for usage, storage, or recycling; status is reported to the VHA-NHPP under password protected code; incumbent updates annually the Approved Radiopharmaceutical Doses for Diagnostic Imaging and Therapeutic Procedures.

Management Skills

Interact effectively with medical facility staff

Present radiation safety information in a clear manner

Organize and maintain a record keeping system

Interact with regulatory agencies.

RSO Authority

The RSO will be provided sufficient authority to:

Implement the written RPP

Identify radiation safety problems

Initiate, recommend, or provide corrective actions

Terminate unsafe operations

Verify implementation of corrective actions and applicable State or Federal regulations

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.

PLACE(s) OF PERFORMANCE:

VA Fargo Health Care System

2101 Elm Street North

Fargo, ND 58103

EQUIPMENT:

Contractor shall furnish all labor, material, supplies, equipment and qualified personnel to provide on-site Radiation Physicist services and Radiation Safety Officer Duties Fargo VA in accordance with the terms and conditions stated herein.

TRAVEL:

All travel expenses will be covered under the contract.

SPECIAL REQUIREMENTS:

The work shall be performed during the FVAHCS regular administrative working hours of 8:00 AM through 4:30 PM, Monday through Friday excluding Federal Holidays. However, there may be times when the Contractor could be needed after regular working hours.

Federal Holidays: The 10 holidays observed by the Federal Government are:

New Year s Day Martin Luther King Jr s Birthday

President s Day Memorial Day

Independence Day Labor Day

Columbus Day Veterans Day

Thanksgiving Christmas

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

Federal Holiday.

Provision of 24 hour on-call services a day, 7 days a week, of contractor

Certified Health Physicist or Medical Physicist (Radiation safety officer) respond to emergency

situations within one (1) hour by phone and on-site within 8 hours if requested.

Physicist must be approved on Radiation Materials License by NHPP.

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

Provide written report of results to Imaging Supervisor or designee within ten (10) working days of performance of the survey.

Opportunity closing date

21 June 2019

Value of contract

to be confirmed