36C24624Q0023.docx

36C24624Q0023 Asheville VAMC Annual Diagnostic Physics Equipment Survey

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.

UEI:

EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

637-24-1-146-0001 36C24624Q0023 10-11-2023 Cleveland Wynne 757-728-3182 10-19-2023 10:00am

EDT

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667 X X 541690 $19 Million

NET 30

N/A X Department of Veterans Affairs Asheville VA Medical Center 1100 Tunnel Road Asheville

NC

28805 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page Contractor shall provide all personnel, supervision and equipment necessary to provide Annual Diagnostics Physics Equipment Testing and Maintenance at Charles George VA Medical Center in Asheville, NC.

This is a Small Business Set Aside.

See CONTINUATION Page 637-3640160-146-822900-2580 010022900 X X X Diane Stoskopf Contracting Officer Table of Contents

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:

b. GOVERNMENT: Contracting Officer 36C246 Diane Stoskopf

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C24624Q0023

Page 1 of Page 1 of

B.3 STATEMENT OF WORK (SOW)

Annual Diagnostic Physics Equipment Survey Charles George VAMC Asheville, NC

PURPOSE

The purpose is to provide regulatory required radiation safety services and medical physics surveys for ionizing radiation producing equipment and MRI of the Charles George VAMC (CGVAMC).

SCOPE

The Contractor shall furnish all necessary travel, labor, material, supplies, tools, equipment, phantoms, RAM sources (if necessary), documentation, and qualified personnel to provide on-site diagnostic medical physics support or services for the Veterans Health Administration (VHA) listed in the Mandatory Services to be performed at CGVAMC, 1100 Tunnel Road, Asheville, NC 28805 under the terms stated herein.

The period of performance is a base year with 4 option years starting on the date of award. Services are to be performed during business hours between 7:30 am and 5:00 pm EST Monday through Friday unless otherwise arranged with the Radiation Safety Officer and COR in advance.

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).

QUALIFICATIONS

Board Certification Authorized Medical Physicist (AMP) / Diagnostic Medical Physicist (DMP) All equipment testing and equipment quality control survey services for and at the facility shall be performed by an AMP / DMP that has board certification in Diagnostic Radiologic Physics or Radiologic Physics by the American Board of Radiology or in Diagnostic Imaging Physics by the American Board of Medical Physics, or in Diagnostic Radiological Physics by the Canadian College of Physicists in Medicine.

https://www.theabr.org/about/abr-board-certification/our-certificates

The contractor shall have sufficient (AMP/DMP) physicists on staff to perform scheduled and emergency services in the case of the scheduled physicist’s unexpected or emergent absence. All nuclear medicine audits, training, licensing prep, and radiation safety officer services require an AMP/DMP that meets the requirements of Title 10 Code of Federal Regulations (10 CFR) § 35.50 for an RSO or Associate RSO and be listed as either on an NC Specific License for radioactive materials, VA radioactive materials permit, or other State’s License for radioactive materials, and provide documentation with offer.

The AMP/DMPs providing services shall have at least 5 years continuous experience for each service in this SOW and provide documentation of experience with offer. The offeror shall provide the RSO with a list of references including at least three federal facilities performing the same of similar services prior to award.

The AMP/DMP shall provide facility RSO with an emergency phone number for urgent or emergent calls for business hours, after hours, and weekends.

The AMP/DMP shall provide a list including at least two AMP/DMPs (One primary and one back-up) for RSO coverage by phone and site-visit upon the unscheduled and emergent leave of the RSO to maintain facility Continuity of Operations for licensed radioactive materials use, urgent equipment testing to continue operations without interruption of patient care or testing and repeat surveys as determined by the RSO. The RSO, Associate COS, COS, AD, or Director must approve requests for emergency services of the AMP/DMP physicist. These physicists must respond to the site physically within 4 upon request for emergent service.

The offeror shall provide the RSO a list of all AMP/DMPs to perform services at the facility with this proposal documentation including active certifications, education, training, experience, and continuing education to meet TJC standards and regulations for an associate RSO. Contractor must be registered and provide documentation for all physicists of NC registration of services in accordance with 10A NCAC 15.0205(d), .0213, .0214(a)(3),(4),(5),(6),(9). In lieu of NC state registration, the offeror may provide documentation of another state’s registration for radiation protection services for equivalent services for approval of the RSO.

http://www.ncradiation.net/regs.htm

Medical Physicists-Not Board Certified (MP) NRC recognizes certain non-certified medical physicists’ education, credentials, and qualifications that are acceptable for certain services in this contract as listed in the federal regulations and TJC standards. Contractors using medical or health physicists in their company not meeting item a. above for an AMP/DMP for any contract services shall provide copies of education, training, and experience requirements as specified above prior to performing services for RSO verification and approval.

Any physicist that is not board-certified as an AMP/DMP must be under the supervision of an AMP/DMP that is available immediately by phone to the facility during any non-certified physicist’s performance of work during or outside business hours. The supervising AMP/DMP’s phone number must be provided to the COR in case of questions. The supervising AMP/DMP shall be certified in the specific subfield(s) for the area of testing.

Any physicist that is not a board-certified AMP/DMP as above must have at least 3 years’ continuous experience for the particular physics and sub-physics field for the service performed or be personally (on-site) supervised by an AMP/DMP when performing services at the facility.

All AMP/DMPs and non-certified physicists must follow continuing medical education in accordance with the ACR Practice Parameter for Continuing Medical Education. https://www.acr.org/- /media/ACR/Files/Practice-Parameters/CME.pdf

Prior to commencing work, the contractor shall submit a list of all non-certified physicists as in above to perform work and must submit current certification, education, training, experience, CME, and NC State registration for the applicable types of physics services for each physicist to the RSO for verification and approval. The submission must be timely enough for credentialing, primary verification, and approval prior to performing services.

The contractor is responsible for maintaining current documentation and automatically submitting to facility RSO or designee prior to expiration to continue services for the contract. Any requested documentation not received with offer shall render the offer unacceptable for this contract. Any change in staff requires same documentation for verification and approval of facility RSO prior to performing services.

Any contractor utilizing sub-contracted physicists or companies to perform any service is required to provide the COR or designee a copy of each sub-contract, each company’s standard operating procedures for the sub-contractor procedure for testing and physics service including the standards, regulations, professional organizations recommendations, accreditation requirements followed, and each contractor’s/sub-contractor’s plan to meet all items above prior to performing services with the offer. The offeror, if using sub-contractors, or other personnel not in its direct employ, is required to provide the COR or designee a copy of the monitoring criteria and quality management plan to monitor the performance of each outside physicist’s work with the offer and a quarterly performance evaluation for each physicist providing services at the facility.

Failure to provide any of the required items listed above will render the offer unacceptable initially or during performance.

DELIVERY – Mandatory Services to be Performed

The physicist (Contractor) shall perform all physics services to ensure compliance with current American College of Radiology (ACR), The Joint Commission (TJC), federal regulations, VHA Directives, Facility requirements, and National Health Physics Program (NHPP) guidelines and standards. In the absence of AAPM, ACR, TJC or NHPP guidance or standards, manufacturer recommendations will be utilized.

Delivery of services will be coordinated through the Radiation Safety Officer or designee. Any deficiencies or non-conformances discovered during the physics services shall be summarized and either emailed or verbally communicated to the Radiation Safety Officer (RSO) prior to the contractor leaving the facility.

Deficiencies or nonconformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers, patients or public shall be reported to the RSO immediately upon discovery.

Reports of services performed shall be formatted to a standardized uniform itemization, order, and arrangement sequence for each type of service for all physicists performing services. The offeror shall provide example uniform and standardized reports for all listed services with the offer.

Attached is an estimate (price list) of yearly number and type of physicist services to be provided.

The scope of services includes the following deliverables:

Regular updates in writing in anticipation of standard and regulation changes and as requested by the facility.

Four (4) hour physical response to facility’s unanticipated and/or emergent requested service on-site. Two (2) business days (48 hours) physical response to facility’s unanticipated and/or urgent requested service on-site.

Monthly scheduled on-site visits by an AMP/DMP to provide services for:

· Radiation safety training including documentation of completion including subjects covered for various radiation areas at an agreed upon schedule with the facility

· Attendance to committee meetings as indicated

· Provide consultation and reports within 5 business days for dose estimates calculated for patient, staff, and fetal exposures and radiation incident/sentinel event investigations as requested

· Assistance with regulatory requirements, industry guidance organizations, and industry best practices

Support the CGVAMC Radiation Safety Office by membership and attendance on the appropriate CGVAMC committee meetings (i.e., Radiation Safety Committee, CT Dose Optimization Committee, Image Quality Committee, etc.) on a quarterly or as needed basis. The CGVAMC Radiation Safety Office expects the authorized medical physicist to be available on site to attend these meetings not less than 4 hours per month for diagnostic radiographic, nuclear medicine, and radiation safety officer qualified expertise on federal regulations, accreditation, industry standards, professional organizations recommendations, radioactive materials licensing, and VHA requirements.

The contractor shall perform at least semi-annually and as needed by the RSO, facility radionuclide emission surveys for air and effluents to meet Title 40 CFR, Chapter I, Subchapter C, Part 61, Subpart I and Title 10 CFR Subpart K, “Waste Disposal”, and 10 CFR 35.92. Compliance with the emission standard shall be determined through the use of either the EPA computer code COMPLY or the alternative requirements of appendix E. The report must include which methods are used for air and effluents and note the applicable regulations. If either air or effluent surveys are not necessary, the report will state such and include the methods used to determine and applicable regulations. The report shall be provided within 30 calendar days of service.

https://www.ecfr.gov/current/title-40/chapter-I/subchapter-C/part-61/subpart-I https://www.nrc.gov/reading-rm/doc-collections/cfr/part020/index.html https://www.ecfr.gov/current/title-10/chapter-I/part-35/subpart-C/section-35.92

Physics services include the following for new equipment or modified rooms in accordance with NCRP Report 147 Structural Shielding Design for Medical X-Ray Imaging Facilities and VHA Design requirements:

· Shielding designs-completed prior to installation of radiation producing equipment. VA requires shielding amounts calculated for an exposure level of 1 mGy (100 mrem) per year and 0.02 mR per hour in an unrestricted (uncontrolled) area and 500 mGy per year in a restricted (controlled) area. Written reports shall be provided within 10 business days of request.

· Shielding integrity tests-completed after installation and prior to clinical use. Written reports shall be provided within 30 calendar days of test.

· Room scatter surveys to include surveys of public areas adjacent to radiation area- completed after installation and prior to clinic use. Written reports shall be provided within 30 calendar days of survey.

· Written reports of items above must be signed by an AMP/DMP documenting the results, including a summary of the methods and assumptions used, instruments used, occupancies calculation method, and a copy of current calibration of instruments used, measurements and deficiencies identified.

The AMP/DMP shall assist in the development of a comprehensive technical quality assurance (QA) program (e.g., technique charts, repeat/reject analysis monitoring, monitoring of exposure indices to radiographic image receptors, QA program for display monitors, QA for CT, monitoring of dose metrics from fluoroscopy studies), which complies with ACR recommendations, for all modalities. The AMP/DMP shall review at least annually the QA program. A written report including recommendations shall be provided to the RSO within 30 calendar days after performing the review.

The AMP/DMP/MP shall conduct equipment inspections and quality control surveys of the imaging equipment at the following intervals listed below:

· Initial inspections and surveys shall be completed after installation and prior to clinical use of new radiation, nuclear medicine, and MR equipment.

· Initial inspections and surveys shall be completed within 30 days of major repair that affects radiation output or image quality.

· Annual inspections and surveys shall be completed at intervals of at least 12 months and no more than 13 months from previous inspection.

· Written reports signed by an AMP/DMP documenting the results to include a summary of the methods and assumptions used, instruments used, current calibration documentation of instruments used, measurements and deficiencies identified.

· These reports in the items above and recommended corrective actions for any non- compliances shall be provided within 15 business days of equipment inspections and quality control surveys.

Equipment inventory may vary and is subject to change during the contract period. The Contractor shall ensure the imaging equipment’s compliance, testing, and use is in conformance with applicable Federal regulations, TJC Standards, ACR accreditation requirements, and AAPM recommendations, and VHA Directives.

The statement of work will be amended as necessary to reflect new or modified equipment or changes in regulatory requirements and expectations.

All physics services shall meet or exceed current and possible future changes in NRC, ACR, NCRP, CRCPD SSR section F, EPA and TJC requirements and recommendations. All services shall meet or exceed the requirements in the following VHA directives and handbooks and future directives and handbooks:

VHA Directive 1105.01, Management of Radioactive Materials https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9188 VHA Directive 1105.02, Nuclear Medicine and Radiation Safety Administrative Service https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7519 VHA 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 Machines Sources of Ionizing Radiation https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3081 VHA Directive 1129.01, Mandatory Reporting of Misadministrations by Therapy Machine Sources of Ionizing Radiation https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3081 VHA Directive 1187, Administrative Practices for Ensuring Safe Injection of Radio-Labeled Blood Products https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6351

The AMP/DMP/MP shall conduct equipment inspections and quality control surveys of the imaging equipment to the specifications included below for Radiographic Equipment:

ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic Equipment.

https://www.acr.org/-/media/ACR/Files/Practice-Parameters/radequip.pdf?la=en Equipment types include Portable X-ray, Fixed Radiographic Only, Fixed Radiographic& Fluoroscopic, and Bone Density.

A dose rate survey in unrestricted areas adjacent to the radiation areas are to be included during testing and in the report.

A patient entrance skin exposure chart (ESE) will be provided for each unit surveyed for common projections and procedures.

The AMP/DMP/MP shall conduct equipment inspections and quality control surveys of the imaging equipment to the specifications included below for Fluoroscopic Equipment:

· ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic Equipment.

https://www.acr.org/-/media/ACR/Files/Practice-Parameters/radequip.pdf?la=en

· Equipment types include Portable X-ray, Fixed Radiographic Only, Fixed Radiographic & Fluoroscopic, and Bone Density.

• A dose rate survey in unrestricted areas adjacent to the radiation areas are to be included during testing and in the report.

· A patient entrance skin exposure chart (ESE) will be provided for each unit surveyed for common projections and procedures.

The AMP/DMP shall conduct equipment inspections and quality control surveys of the imaging equipment to the specifications included below for CT Equipment:

ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Fluoroscopic Equipment and VHA Directives.

https://www.acr.org/-/media/ACR/Files/Practice-Parameters/fluoro-equip.pdf?la=en

The AMP/DMP shall conduct equipment inspections and quality control surveys of the imaging equipment to the specifications included below for CT Equipment:

• ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment or ACR Accreditation Testing Requirements, and VHA requirements, and TJC standards.

https://www.acr.org/-/media/ACR/Files/Practice-Parameters/CT-Equip.pdf

· Equipment types include Diagnostic CT units.

· Image acquisition display monitors shall be tested in accordance with American Association of Physicist in Medicine (AAPM) On-Line Report No. 03 Assessment of Display Performance for Medical Imaging Systems.

· The contractor shall review the CT protocol optimization program, QA/QC program and approve CT protocols at least annually with the inspection.

· A dose rate survey in unrestricted areas adjacent to the radiation areas are to be included during testing and in the report.

· A dose output/patient entrance skin exposure (ESE) chart will be provided for each unit surveyed for common projections and procedures.

The AMP/DMP/MP shall conduct equipment inspections and quality control surveys of the imaging equipment to the specifications included below for Dental Equipment and Dental Acquisition Display Monitors:

· National Council on Radiation Protection and Measurements (NCRP) Report 177- Radiation Protection in Dentistry and Oral & Maxillofacial Imaging (2019) (Supersedes Report No. 145).

· Equipment types include Intraoral, Portable, Panoramic and CBCT Dental units.

· Dental written reports shall include reference Diagnostic Reference Levels (DRL).

The AMP/DMP shall conduct equipment inspections and quality control surveys to the specifications included below for Magnetic Resonance (MR) Imaging equipment:

· ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Magnetic Resonance Imaging (MRI) Equipment or ACR Accreditation Testing Requirements, and VHA requirements, and TJC standards.

· https://www.acr.org/-/media/ACR/Files/Practice-Parameters/mr-equip.pdf?la=en

· Equipment types include MRI units.

· Image acquisition display monitors shall be tested in accordance with American Association of Physicist in Medicine (AAPM) On-Line Report No. 03 Assessment of Display Performance for Medical Imaging Systems.

The AMP/DMP shall conduct equipment inspections and quality control surveys of the imaging equipment to the specifications included below for Nuclear Medicine Gamma Camera SPECT- CT Imaging equipment:

· ACR-AAPM Technical Standards for Medical Physics Performance Monitoring of Gamma Cameras and SPECT-CT Imaging Equipment or ACR Accreditation Testing Requirements, and VHA requirements, and TJC standards.

https://www.acr.org/-/media/ACR/Files/Practice-Parameters/gamma-cam.pdf?la=en https://www.acr.org/-/media/ACR/Files/Practice-Parameters/spect-ct-equip.pdf?la=en

· Equipment types include Gamma Camera SPECT-CT units

The AMP/DMP/MP shall perform annual testing of image acquisition display monitors in accordance with American Association of Physicist in Medicine (AAPM) On-Line Report No. 03 Assessment of Display Performance for Medical Imaging System for the following areas: CT, Nuclear Medicine, MRI, and PET.

The AMP/DMP shall perform Nuclear Medicine Program Audits quarterly and as requested that include compliance with regulations and facility SOP:

· Quality management program records

· Radiation Safety Survey records:

Daily radiation area surveys Weekly radiation area surveys Weekly wipe tests Radioactive contamination records-of the environment, patients, personnel, or equipment

· Sealed source records Perform sealed source leak tests Perform sealed source inventory Sealed sources security-sources secured, maintained, and stored appropriately

· Survey Meters Records Survey meter calibrations Survey meter constancy checks

· Facility Personnel Dosimetry Records Dosimetry records review ALARA notifications to employees Regulatory limits notifications

· Postings Emergency phone numbers Emergency procedures Regulatory and VA required postings

· Available Safety/Protective Devices Lab coats/gloves/shields

· Dose Calibrator Records Perform physics testing: calibration, accuracy, geometry dependence, linearity, etc. as required Review daily constancy records Review repair records

· Well Counters Records Perform physics testing: calibration, efficiency, chi square, minimum detectable activity, etc. as required Review daily auto calibration and constancy records Review repair records

· Patient Dose Administrations Assay of each patient dose Medical events or reportable events records VA required radiologist approval and protocol for each procedure records

· Radioactive Materials Receipt Records Records of radioactive materials receipt Records of radioactive materials radiation survey levels/removable contamination

Security of radioactive materials

· Radioactive Materials Decay in Storage Records Records of decay in storage radiation survey levels Records of decay in storage disposal

· Radioactive Materials Disposal/Exchange Records Records of returned containers Records of sealed source receipt and return

· Equipment Service Gamma Cameras (SPECT/CT) Survey meters Dose calibrator Uptake probe and well counters

· Equipment/Instrument Quality Control SPECT/CT required testing records Dose calibrator required testing records Uptake probe and well counters required testing records Survey meters required testing records

· Administrative Radioactive materials facility permit Regulations / Inspection records posted appropriately and available on-site Policies and procedures Radiation safety program

· Perform annual radiation safety training for nuclear medicine technologists

· All of the above items shall be addressed in a written report provided to the RSO within 21 calendar days of the audit. The contractor shall present a summary and report of all physics services performed at the quarterly CGVAMC Radiation Safety Committee meeting held in March, June, September, and December and provide a copy of this report to the RSO prior to the meeting if before 21 calendar days.

The AMP/DMP shall provide assistance implementing a Direct Digital Radiography (DDR) QA/QC Program to meet regulatory requirements, industry standards and manufacturer’s requirements to include the following items:

· Exposure indicators acceptable ranges for routinely performed examinations

· Image QC program in accordance with the system manufacturer, or a nationally recognized organization

· If applicable, provide assistance implementing quarterly complete phantom image evaluation recommendations that include at a minimum-items from CRCPD SSR section F.3.b.iv.(3).

· Review of DDR QA/QC Program annually by contractor.

· Provide report of DDR system initial implementation recommendations and annually thereafter within 30 days of review.

Routine scheduled services: The AMP/DMP/MP must provide an estimated time for completion of services for each visit upon scheduling request for clinic and patient exam scheduling purposes. Services that are scheduled for completion after hours must be approved by the COR prior to visit for escort and access coordination with applicable departments. Routine Services are required to be scheduled with the facility upon request and completed within 7 calendar days during business hours unless approved by COR prior to visit.

Urgent Services: The AMP/DMP/MP services designated as urgent require physical response time to the facility within 48 hours of request and visit must be approved and scheduled by the RSO.

Emergent Services: The AMP/DMP/MP services designated as emergent require physical response time to the facility within 4 hours of request and visit must be approved and scheduled by the RSO, COS, Associate COS, or Director.

5. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

The contractor employees shall not have access to CGVAMC sensitive or computer information and will not require routine access to CGVAMC Facilities. The contractor employees shall require intermittent physical access only and will be escorted by CGVAMC employees while at CGVAMC Facilities. The contractor owned IT devices (such as laptop computer) shall not interface with any VA internet trusted (i.e., non-public) network.

Therefore, the VHA certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required. Contractor shall not copy, print, or otherwise record any sensitive patient information. No background investigation is required.

Position Risk/Sensitivity. For all positions required under this contract, the position risk/sensitivity has been designated as: Low Risk/Non-Sensitive.

The primary contractor is responsible to provide the VA facility CO/COR with list of all contractor and subcontractor (if applicable) personnel. These items must be received, verified, and approved by the RSO prior to scheduling for services.

6. HOURS OF OPERATION

Work will be done at the Charles George VA Medical Center (VAMC), Asheville, NC and may be accomplished as scheduled in advance with the COR, during normal business hours: 7:00 AM to 4:30 PM, Monday through Friday, excluding National Holidays: New Years’ Day, Martin Luther King, Presidents’ Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans’ Day, Thanksgiving, Christmas.

Phone: The contractor shall provide an office number with availability during business hours, urgent, and emergent access as listed in this SOW.

Email: The contract shall provide an email address and provide information requested within 2 business days of request.

7. DEFINITIONS/ABBREVIATIONS

AAPM-American Association of Physicists in Medicine ACR-American College of Radiology AD-Associate Director ALARA-As Low As Reasonably Achievable AMP-Authorized Medical Physicist CBCT-Cone Beam Computed Tomography CFR-Code of Federal Regulations CGVAMC-Charles George VA Medical Center CME-Continuing Medical Education CO-Contract Officer COOP-Continuity of Operations COMPLY-EPA Computer program used to demonstrate compliance with NESHAPS COR-Contract Officer’s Representative COS-Chief of Staff CRCPD-(SSR)-Conference of Radiation Control Program Directors, Inc.(Suggested State Regulations) CT-Computed Tomography DDR-Direct Digital Radiography DIS-Decay-In-Storage DMP-Diagnostic Medical Physicist

DRL-Diagnostic Reference Level EPA-Environmental Protection Agency ESE-Entrance Skin Exposure MP-Medical Physicist MR-Magnetic Resonance MRI-Magnetic Resonance Imaging NC-North Carolina NCRP-National Council on Radiation Protection NESHAPS-National Emission Standards for Hazardous Air Pollutants NHPP-National Health Physics Program PET-Positron Emission Tomography QA-Quality Assurance QC-Quality Control RAM-Radioactive Materials RSO-Radiation Safety Officer SIC-Security and Investigations Center SOW-Statement of Work SPECT-Single Photon Emission Computed Tomography TJC-The Joint Commission VHA-Veteran’s Health Administration

10/01/23-09/30/24-Base Year

EA=each

Item #

Description

Unit Est.

Qty.

Unit Price

Total

Radiographic Equipment Services: Tube Inspection/QC Survey-Radiographic, fluoroscopic, C-arm mobile, portable XR, Bone Density, Dental (each tube)

EA

TOTAL

10/01/24-09/30/25-option year 1

EA=each

Unit Est.

Qty.

Radiographic Equipment Services: Tube Inspection/QC Survey-Radiographic, fluoroscopic, C-arm mobile, portable XR, Bone Density, Dental (each tube)

TOTAL

10/01/25-09/30/26-Option Year 2

EA=each

Unit Est.

Qty.

Radiographic Equipment Services: Tube Inspection/QC Survey-Radiographic, fluoroscopic, C-arm mobile, portable XR, Bone Density, Dental (each tube)

TOTAL

10/01/26-09/30/27-Option Year 3

EA=each

Unit Est.

Qty.

Radiographic Equipment Services: Tube Inspection/QC Survey-Radiographic, fluoroscopic, C-arm mobile, portable XR, Bone Density, Dental (each tube)

TOTAL

10/01/27-09/30/28-Option Year 4

EA=each

Unit Est.

Qty.

Radiographic Equipment Services: Tube Inspection/QC Survey-Radiographic, fluoroscopic, C-arm mobile, portable XR, Bone Density, Dental (each tube)

TOTAL

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

What will be monitored?

How monitoring will take place.

Who will conduct the monitoring?

How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Tammy Mulkey, Radiation Safety Officer Organization or Agency: Charles George VA Medical Center

CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract.

Primary:

Alternate:

PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

DIRECT OBSERVATION. 100% surveillance: Performed by the Radiation Safety Department PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed.

PERFORMANCE MEASURES

Reference

Quality Level Surveillance Method

Any other non-conformance/deficiencies found shall be reported in a summary by email or voice mail to the RSO within 24 hrs. of finding.

/ Analysis of reports

Medical Physicists

(MP)

Management / Quality

Contractor (including supervising AMP/DMP) must be available as specified in the SOW.

Management / Quality / Safety

requested.

Management /…