S02 - Combined Synopsis 36C24823Q1710 - 7-28-2023.docx

COMBINED SYNOPSIS/SOLICITATION RFQ 36C24823Q1710

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with Part 13, as supplemented with additional information included in this notice. This procurement is being conducted under Subpart 13.5 Simplified Procedures for Certain Commercial items. This announcement constitutes the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04, effective 6/2/2023.

This solicitation is 100% set-aside to Small Business. The North American Industrial Classification System (NAICS) code for this procurement is 541690, Other Scientific and Technical Consulting Services, with a small business size standard of $19 million.

The Network Contracting Office 8-RPO East intends to award a fixed priced contract, providing Diagnostic Medical Physics Support for Bay Pines VA Health Care System (BPVAHCS) in accordance with the below Statement of Work (SOW) and attached Price Schedule.

This solicitation will use Comparative Evaluation. The award will be made to the offeror determined to be acceptable, price reasonable, and is determined to provide the best value to the government. All eligible offerors may submit quotes.

Responses shall be on all or none basis, no partial submissions will be accepted. Quote must be valid for 90 days. All offerors must be registered in System for Award Management (SAM) at https://www.sam.gov at time offers are due to be considered for an award of a federal contract. Registration must be complete and not missing elements such as representations and certifications. Also, if you are a Service-Disabled Veteran Owned Business (SDVOSB) or Veteran-Owned Small Business (VOSB) please be sure to be registered in Veteran Small Business Certification (VetCert) at Veteran Small Business Certification (sba.gov)

VENDOR QUESTIONS: All questions regarding this RFQ must be in writing and may be sent by e‐mail to Annette.whitfield@va.gov Questions must be received no later than Thursday, 8/3/2023 by 4:00 PM Eastern. No further questions will be accepted after that date and time.

ANSWERS TO VENDOR QUESTIONS: Answers to vendor questions will be posted no later than Wednesday, 8/9/2023 by 4:00 PM Eastern.

*QUOTE SUBMISSION: Offers are due on/or before Tuesday 8/15/2023 by 4:00 PM Eastern. All quotes shall be sent by e‐mail “only” to the Contracting Officer Annette Whitfield-Johnson at Annette.whitfield@va.gov. The Government will award a Firm Fixed Priced (FFP) contract resulting from this RFQ to the responsible vendor whose quote using comparative analysis using evaluation factors and is the best value to the Government.

*Vendors are required to follow the “Instructions to Quoters” on pages 52 – 54 of this Synopsis/Solicitation RFQ.

Schedule of Services Diagnostic Medical Physics On-Site Support and Services These services shall be on site at the C. W. Bill Young VAMC, Lee County Healthcare Center, Cape Coral, Florida, and Bradenton Outpatient Clinic, Bradenton, FL in accordance with the terms and conditions herein. Contractors shall quote prices for all the Contract Line- Item Numbers.

PRICE/COST SCHEDULE

ITEM INFORMATION

Diagnostic Medical Physics Support Service at CWBYVAMC in accordance with SOW.

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024

Diagnostic Medical Physics Support Service at LCHCC in accordance with SOW.

Diagnostic Medical Physics Support Service at BOPC in accordance with SOW.

Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025

Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026

Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027

Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028

Statement of Work

STATEMENT OF WORK

Diagnostic Medical Physics Support Services

General Requirements The Contractor shall provide one visit (minimum six hours per visit) each quarter. These services shall be on site at the C.W. Bill Young VA Medical Center (CWBYVAMC), Bay Pines, FL, and periodically at the Lee County Healthcare Center (LCHCC) Cape Coral, FL, and Bradenton Outpatient Clinic (BOPC) Bradenton, FL.

All services shall be performed on a regularly scheduled basis to be established upon award of contract. Necessary audits, reviews, spot surveys, equipment testing, subcommittee meeting attendance, etc. shall be conducted during these visits in preparation of quarterly reports to be presented at the scheduled Bay Pines VA Healthcare System (BPVAHCS) Radiation Safety Committee meeting. The site of scheduled visits (Bay Pines, Cape Coral or Bradenton) will be at the discretion of the Contracting Officer’s Representative (COR).

The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site diagnostic medical physics support or services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must adhere to the Joint Commission requirements and standards for medical imaging, conduct performance evaluations in accordance with applicable American College of Radiology guidelines, follow relevant VHA Directives, including VHA Directive 1129, http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3081 and VHA Handbook1105.04, Fluoroscopy Safety, dated July 6, 2012, http://vaww./va.gov/vhapublications/ViewPublications.asp?pub_ID=2764 Locations: The services shall be on site at the following locations:

· C.W. Bill Young VAMC, 10000 Bay Pines Blvd, Bay Pines, FL 33744

· Lee County Health Care Center, 2489 Diplomat Parkway East, Cape Coral, FL 33909

· Bradenton Community-Based Outpatient Clinic, 5520 S.R. 64, Suite 101, Bradenton, FL 34208

Hours of Operation:

Work will be done at all locations during normal business hours: 8:00 AM to 4:30 PM, Monday through Friday, excluding National Holidays:

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).

1: Annual review of BPVAHCS overall Imaging Quality Assurance program for diagnostic imaging equipment. [NHPP] 2: Annual quality assurance testing survey of all diagnostic x- ray and imaging equipment (to include MRI and Ultrasound systems). See Attachments A for x-ray tubes and in designated specialties, i.e., nuclear medicine, ultrasound, etc. for a list of equipment. [TJC, NHPP] 3: Reports signed by the diagnostic medical physicist documenting the testing, including a summary of methods, instruments used, measurements and deficiencies identified, for all diagnostic x-ray and imaging equipment will be provided within five days of completion of the work. The report shall be kept in a repository in electronic format that can be retrieved and viewed on-line by the COR and RSO.

4: Deficiencies or non-conformances which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports must be provided after testing so that BPVAHCS will know that equipment can be immediately put into use.

5: Shielding design approvals for new construction and renovations.

6. Shielding surveys for new construction, modifications and replacement of equipment.

7: Annual quality assurance testing of mammography equipment. [MQSA] 8: Support the BPVAHCS Radiation Safety Office by membership and attendance on the appropriate BPVAHCS committee meetings (i.e., Radiation Safety Committee, CT Dose Optimization Committee, etc.) on a quarterly or as needed basis. [TJC] 9: Provide consultation and final reports for dose estimates calculations for patient, staff and fetal exposures and sentinel event investigations.

10: Emergency response on equipment shall be within 3 hours. The contractor must be able to respond to all locations identified in this SOW within the 3 hours at the same time.

11. The physicist shall perform all work with his own equipment and shall provide a current date of calibration in the final report. Certificates of instrument calibrations will be available online for review as needed.

The annual quality assurance testing will include all radiology and dental equipment at BPVAHCS; Bay Pines VAMC, Lee County VAHCC and Bradenton clinic. All quality assurance testing reports and mammography equipment performance evaluations reports shall be submitted to the BPVAHCS Radiation Safety Office for review and approval subsequent to the completion of all testing, calibration and surveys of the equipment, facilities and procedures. The reports shall identify all items of noncompliance and include general and specific recommendations for correcting any items of noncompliance. “All records (administrative and program specific) created during the period of the contract belong to Bay Pines VA Health Care System(BPVAHCS) and must be returned to BPVAHCS at the end of the contract or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1.”

12. Quality Assurance Testing, all Quality Assurance Tests shall meet or exceed current and possible future changes in NRC, ACR, MQSA, NCRP, FDA and TJC requirements and recommendations. All Quality Assurance Tests 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

· VHA Handbook 1105.02, Nuclear Medicine and Radiation Safety Service

· VHA Handbook 1105.03, Mammography Program Procedures and Standards

· VHA Handbook 1105.04, Fluoroscopy Safety

· VHA Handbook 1105.05, MRI Safety

1. Performance All work shall be signed off by a qualified diagnostic medical physicist. A qualified diagnostic medical physicist is a person who is certified by the American Board of Radiology, American Board of Medical Physics, or the Canadian College of Physicists in Medicine. For mammography, a qualified medical physicist must have state licensure to perform mammography inspections in lieu of board certification and certification must be from the State of Florida. For diagnostic computed tomography (CT), nuclear medicine, PET, or MRI, a qualified medical physicist can meet the following requirements in lieu of board certification:

· A graduate degree in physics, medical physics, biophysics, radiologic physics, medical health physics, or a closely related science or engineering discipline from an accredited college or university

· Formal graduate-level coursework in the biological sciences with at least one course in biology or radiation biology and one course in anatomy, physiology, or a similar topic related to the practice of medical physics Physicist must document the 3 years of experience for the modality being inspected.

2. Mandatory Services to be Performed

a. The qualified diagnostic medical physicist, or their designate, shall perform imaging equipment (x-ray equipment, nuclear medicine cameras, PET/CT cameras, ultrasound units, and MRIs) inspections to ensure compliance with the current American College of Radiology (ACR) and Mammography Quality Standards Act (MQSA) requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the service supervisor or RSO prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO immediately upon discovery. A report of the results shall be provided electronically to the RSO within 5 working days after completion of the inspection. The report shall be kept in a repository in electronic format that can be retrieved and viewed on-line by the COR or RSO.

All imaging equipment (except nuclear medicine cameras, and PET which are quarterly) shall be inspected at least annually, but not to exceed 14 months.

b. The qualified diagnostic medical physicist shall perform acceptance testing of all new or relocated imaging equipment prior to first clinical use. Testing shall comply with ACR or MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the service supervisor or RSO prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO immediately upon discovery. A report of the results shall be provided to the RSO within 5-working days after completion of the inspection. The report shall be kept in a repository in electronic format that can be retrieved and viewed on-line by the COR or RSO.

c. The qualified diagnostic medical physicist shall perform structural shielding design calculations for any room in which a fluoroscopic imaging system is to be installed, or in which a mobile fluoroscopic imaging system is frequently used, the doses to persons in adjacent areas, including any areas above and below, must be evaluated by a diagnostic medical physicist or medical health physicist. [VHA Directive 1105.04] For the structural shielding of rooms containing x-ray imaging devices, the shielding design goal must be 5 milligray (mGy) in a year to any person in a controlled area. For uncontrolled areas, the shielding design goal needs to be 1 mGy in a year to any person, and 0.02 mGy in any hour. [VHA Directive 1105.04] The design of shielding for and acceptance testing surveys of imaging rooms must conform to National Council on Radiation Protection and Measurements (NCRP) Report No. 147, Structural Shielding Design for Medical X-ray Imaging Facilities. The shielding design calculations, as-built shielding plans, and the report on the acceptance testing of the structural shielding must be kept for the duration of use of the room for x-ray imaging. [VHA Handbook 1105.04] Qualifications: Prior to commencing work, all contractor employees shall meet certain criteria to perform work under this contract as a Diagnostic Medical Physicist. Qualification documents must be submitted as part of the bid to the Contracting Officer and be approved by the RSO or his/her designee. All qualifications are subject to review by the BPVAHCS Chief of Radiation Safety Service.

d. The qualified diagnostic medical physicist shall provide consultation for additional services as needed, i.e., safety training. The Contractor shall provide and carry a personal telephonic pager or cell phone and respond to Bay Pines VAHCS by telephone within 10 minutes for consultations and when needed shall be on-site within (1) hour of being notified during normal business hours (0800 to1630 hrs. Monday through Friday) for emergency procedures. (Contractor will be compensated for emergency visits separate from this contract.)

e. The qualified diagnostic medical physicist shall review CT protocols at least annually.

f. The qualified therapeutic medical physicist shall provide medical physicist peer review for radiation oncology service at least quarterly, following ACR guidelines and American Association of Physicists in Medicine (AAPM) TG 103 report.

g. Personal lead protective apparel shall be inspected for their integrity of radiation protection and documented by the surveyor.

3. Equipment Inspections The Contractor shall conduct equipment inspections or quality control surveys of the imaging equipment listed below in Appendix A and any replacement or addition to list. The Contractor shall ensure the imaging equipment’s compliance with applicable Federal regulations and ACR recommendations, and shall include, but not be limited to, monitoring the following basic performance characteristics.

A. Radiographic and Fluoroscopic Equipment Physics inspections of radiographic and fluoroscopic equipment shall comply with the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment. The performance of each radiographic and fluoroscopic unit must be evaluated at least annually.

The content of annual surveys is described as follows. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Integrity of unit assembly.

(2) Collimation and radiation beam alignment.

(3) Fluoroscopic system spatial resolution.

(4) Automatic exposure control system performance.

(5) Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed modes, field-of-view [FOV] variation).

(6) Image artifacts.

(7) Fluoroscopic phantom image quality.

(8) kVp accuracy and reproducibility.

(9) Linearity of exposure versus mA or mAs.

(10) Exposure reproducibility.

(11) Beam quality assessment (half-value layer).

(12) Fluoroscopic entrance exposure rate (or air kerma rate). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation [e.g., magnification mode, frame rate, and any other mode selected) must be documented for each measurement.]

(13) Fluorographic (image recording) entrance exposure rate (or air kerma rate) for cine imaging, if performed and entrance exposure (or air kerma) for spot images (if performed). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation (e.g., magnification mode, frame rate, etc.) must be documented for each measurement.]

(14) Equipment radiation safety functions.

(15) Patient dose monitoring system accuracy for appliable systems. This includes for fluoroscopy systems, the displays of air kerma or, if available, DAP.

Note: The information on entrance exposure rates (or air kerma rates) from fluoroscopy and from fluorography, in applicable above, for each fluoroscope, shall be in a format suitable for providing to the physicians who operate the fluoroscope. If the review of clinically used technique factors or the comparison of measured dose indices with national standards indicates that an optimum balance has not been achieved between patient dose and image quality or that the dose indices exceed national standards, the technique factors, whether posted in a chart or programmed into the fluoroscope, must be modified as necessary. [VHA Handbook 1105.04] B. CT Scanners The physics inspection shall conform to current ACR Computed Tomography Quality Control Manual. The performance of each CT scanner shall be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Review of Clinical Protocols.

(2) Scout Prescription and Alignment Light Accuracy.

(3) Table Travel Accuracy.

(4) Radiation Beam Width.

(5) Low-Contrast Performance.

(6) Spatial Resolution.

(7) CT Number Accuracy.

(8) Artifact Evaluation.

(9) CT Number Uniformity.

(10) Dosimetry (the scanner displayed CTDIvol values must be within +/- 250% of the measured CTDIvol values).

(11) Gray Level Performance of CT Acquisition Display Monitors.

C. Dental The physics inspection shall conform to the Conference of Radiation Control Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography Volume 1 Dental Facilities July 2001. The performance of dental x-ray inspections shall be annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Beam quality (half value layer).

(2) Timer Accuracy and Reproducibility.

(3) kVp Accuracy and Reproducibility.

(4) mA or mAs Linearity.

(5) Exposure Reproducibility.

Dental CBCT Acceptance and Performance Testing

1. Acceptance Testing. For acceptance testing, evaluate KAP/DAP readings accuracy of this value in air using an appropriate radiation detector and a radioluminescent sheet. Perform CTDIvol measurements. Using the manufacturer’s phantom(s), evaluate system in accordance with the manufacturer’s instructions.

2. Performance Testing. Each CBCT unit shall undergo periodic quality control tests to ensure that the performance of the machine has not significantly deteriorated and is operating within the manufacturer’s technical specifications. This performance testing is performed by a qualified expert annually, at intervals not to exceed 14 months, and after repairs to the CBCT unit that may affect the radiation output or image quality.

D. Mammography The qualified diagnostic medical physicist inspecting mammography equipment must meet the qualifications outlined in the MQSA and shall provide the facility with up-to-date documentation demonstrating the qualified diagnostic medical physicist is MQSA qualified. Inspections of mammography equipment must comply with the latest requirements posted on the ACR Web site for the manufacturer of the digital mammography unit being inspected. Inspection items may include:

(1) Mammographic Unit Assembly Evaluation.

(2) Collimation assessment.

(3) Artifact evaluation.

(4) kVp accuracy and reproducibility.

(5) Beam quality assessment – HVL measurements.

(6) Evaluation of system resolution.

(7) Automatic Exposure Control (AEC) function performance .

(8) Breast entrance exposure, AEC reproducibility, and average glandular dose.

(9) Radiation output rate.

(10) Phantom image quality evaluation.

(11) Signal–to–noise ratio and contrast–to noise ratio measurements.

(12) Review Workstation (RWS) tests.

E. MRI

The physics inspection shall conform to the 2015 ACR Magnetic Resonance Imaging Quality Control Manual. The performance of each MRI scanner shall be evaluated at least annually. Current inventory is four (4) MRI units. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Magnetic field homogeneity.

(2) Geometric accuracy.

(3) Inter-slice RF interference.

(4) Slice position accuracy.

(5) High-contrast resolution

(6) RF coil performance.

(a) Volume coils’ signal-to-noise ratio

(b) Volume coils’ image uniformity

(c) Volume coils’ ghosting ratio

(d) Phased array coils' signal-to-noise ratio

(e) Surface coils’ signal-to-noise ratio

(7) Slice thickness accuracy

(8) Low-contrast detectability

(9) Soft copy displays

(10) Technologist’s QC program

(11) Site phantom inventory

(12) Site RF coil inventory F. Nuclear Medicine Service at the Bay Pines and Lee County locations Contractor shall be responsible to:

a. Monitor absorbed radiation in individual patients as requested by Nuclear Medicine physicians as requested.

b. Calculate spilled gas clearance time based upon semi-annual airflow measurements made by engineering. Evaluate performance of Xenon delivery system.

d. Perform annual calibration of Thyroid Uptake and Well Counter Systems for the multi-channel analyzer/thyroid uptake units, and dose calibrator well counters. Perform geometry testing of dose calibrators, when needed.

h. Perform sealed source leak test and provide report (quarterly).

i. All of the above items shall be addressed in a report, which shall be presented and reviewed at the quarterly Bay Pines VAHCS Radiation Safety Committee meeting held quarterly.

j. Assist with consultation license renewals and amendments for VHA and NRC submission.

G. PET/CT

The physics inspection shall conform to the ACR PET Phantom Instructions for Evaluation of PET Image, ACR Nuclear Medicine Accreditation Program PET Module. The performance of each PET scanner shall be evaluated at least quarterly. For PET/CT units the CT must be inspected at least annually for CT scanners above. Current inventory of one (1) PET/CT unit. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Uniformity.

(2) Spatial resolution.

(3) SUV analysis.

H. Nuclear Medicine The physics inspection shall conform to the ACR annual performance tests for nuclear medicine cameras. The qualified diagnostic medical physics shall also perform the quarterly testing as outlined by the ACR. The performance of each nuclear medicine scanner shall be at least annually. Current inventory of five (5) gamma cameras. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Intrinsic Uniformity

(2) System Uniformity

(3) Intrinsic or System Spatial Resolution

(4) Relative Sensitivity

(5) Energy Resolution

(6) Count Rate Parameters

(7) Formatter/Video Display

(8) Overall System Performance for SPECT

(9) System Interlocks

(10) Dose Calibrators (Geometry, if applicable, Accuracy)

(11) Thyroid Uptake and Counting Systems I. Ultrasound The physics inspection shall conform to the ACR performance tests for ultrasound. Annually, the following tests should be done for each ultrasound unit. Testing shall be done using all transducers commonly used with each unit. Data shall be taken from testing of the transducers which are used for the most frequently occurring examination(s) at the site.

(1) System Sensitivity/Penetration This test should be done with the following settings:

• maximum transmit power

• proper receiver gain and TGC that allows echo texture to be visible in the deep region

• transmit focus at the deepest depth The maximum depth of visualization is determined by comparing the gradually weakening echo texture to electronic noises near the bottom of the image.

(2) Image Uniformity Adjust the TGC controls and other sensitivity controls to obtain an image as uniform as possible.

• vertical or radially oriented streaks?

• dropouts?

• reduction of brightness near edges of the scan?

• brightness transitions between focal zones?

(3) Electrical and Mechanical Safety and Cleanliness

• Are all cords and cables intact (no frays)?

• Are all transducers intact without cracks or delamination?

• Are the transducers cleaned after each use?

• Are the image monitors clean?

• Are the air filters clean?

• Are the wheel locks in working condition?

• Are the wheels fastened securely to the US unit and do the wheels rotate easily?

• Are all accessories (VCR, cameras, etc.) fastened securely to the US unit?

(4) Gray Scale Photography (if applicable) – Do either (a), (b), or (c).

(a) For Scanners with a Discrete Bar Pattern Count the number of distinct gray bar steps on the viewing monitor. Then count the number of steps visualized in the gray bar on the hard copy image.

(b) For Scanners with a Continuous Gray Bar Pattern Use calipers to measure the length of the black-to-white transition of the gray wedge on the viewing monitor. If the relative length of the black-to-white transition on the hard copy image is less, document how much is missing.

(c) For Laser Imager (Hard Copy Device) Prior to filming any images, an SMPTE test pattern created by the Society of Motion Picture and Television Engineers (SMPTE), should be printed using the appropriate window width (WW) and window level (WL). If you are unfamiliar with this procedure, you should review Gray et al., “Test pattern for video display and hard-copy camera,” Radiology 145:519-527 (1985), and then contact your local service engineer for assistance. When printed, the 95% density patch within the 100% square and the 5% density patch within the 0% square should be visible, and there should be no notable distortions or artifacts present. If these criteria are not met, contact your service engineer for laser camera calibration before proceeding with any filming.

(5) Hard Copy Output Quality Test (Digital) (if applicable) This test, or a similar test specifically recommended by the hard copy equipment manufacturer.

Required Test Equipment

• Densitometer

• SMPTE Test Pattern or another similar test pattern or phantom image having a wide range of gray scales.

The same test image should be used each time.

J. Display Monitors or Acquisition Monitors The annual performance evaluation conducted by the diagnostic medical physicist includes testing of image acquisition display monitors for maximum and minimum luminance, luminance uniformity, resolution, and spatial accuracy. The image acquisition display monitors for nuclear medicine, PET, CT, and MRI units shall be tested.

K. Contractor Personnel Security Requirements - Information Systems Access Upon contract award, all personnel with access to the facility shall be subject to the appropriate type of background investigation or screening per VA/VHA policy as delineated below and must receive a favorable adjudication from the local VA facility or VA Security and Investigations Center (SIC) depending on the type of investigation/screening required. This requirement is also applicable to all subcontract personnel.

Contract personnel who previously received a favorable adjudication as a result of a government background investigation or screening may be exempt from this contract requirement provided that they can provide documentation to support the previous adjudication. Proof of previous adjudication must be submitted by the Contractor to VA Contracting Officer. Proof of previous adjudication is subject to verification. Some positions maybe subject to periodic re-investigation/screening.

Position Risk/Sensitivity. For all positions required under this contract, the position risk/sensitivity has been designated as: Low Risk/Non-Sensitive Prior to completing the required forms, contract personnel should review the attachments entitled Common Errors on NACI Security Questionnaires, Example_SF85, Example_OF306, and General Questions and Answers about OPM background Investigations (see item 3.2 of this contract for these attachments) in order to ensure the forms are properly completed. Please note that incomplete forms will be rejected and could result in a delay of work under the contract.

Once the items requested are received, VA will pre-screen these items for completeness, and forward them to the appropriate party(s) in order to initiate the required background investigation(s) or screening(s) within fourteen (14) calendar days of appointment. Only after the VA Contracting Officer notifies the Contractor that the background investigation(s) or screening(s) was initiated shall the Contractor be authorized to provide services under the contract The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the contract person from consideration of working under the contract.

Failure to comply with these Contractor personnel security requirements may result in termination of the contract for default.

Information Security The diagnostic medical physicist working with the contractor may have access to sensitive patient information displayed on the control panel of X-ray equipment. However, contractor owned IT devices (such as laptop computer) shall not interface with any VA internet trusted (i.e., non-public) network. Therefore, the certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required. Contractor shall not print or copy any sensitive patient information.

The current inventory of x-ray producing equipment is listed below. The statement of work will be amended as necessary to reflect new or modified equipment or changes in regulatory requirements and expectations.

GENERAL INFORMATION:

L. SURVEILLANCE: The government QA (COR & RSO) will evaluate the objectives through periodic inspections during the service.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

This QASP was developed to evaluate contractor actions while implementing this SOW. It is designed to provide an effective method of monitoring contractor performance for each listed objective in the SOW and on the Service Delivery Summary (SDS) table below. The QASP provides a systematic method to evaluate the services the contractor is required to furnish.

This QASP is based on the premise that the Government desires to maintain a quality standard in the operation of the systems to be serviced under this agreement and to provide the service is the best means of achieving that objective. The Contractor, not the Government, is responsible for management & quality control actions to meet the terms of the contract. The Government’s role is quality assurance to ensure contract standards are achieved. Contractor shall be given adequate time to correct the unacceptable performance. If deficiencies are not corrected timely, the COR shall notify the Contracting Officer for action.

Must meet standard 100%

Monitor through COR & RSO

• Compliance Inspections

• Acceptance Testing

• Shielding Design Calculations

• Full Inspections after modifications or repairs

• QA Program Reviews & Consultation

• Survey Reports

• Nuclear Medicine Unit inspections shall be conducted Quarterly

• All other Imaging equipment inspections (except for the 2 categories noted above), shall be conducted Annually

• Will ensure the imaging equipment’s compliance with applicable Federal regulations and ACR recommendations; & shall include monitoring the basic performance characteristics of each modality as specified in the SOW

• Annual inspection shall include testing of image acquisition display monitors to include maximum & minimum luminance, luminance uniformity, resolution, & spatial accuracy

• Full inspection will be performed within 48 hours after vendor is contacted regarding modifications or repairs to imaging equipment that may affect the radiation output or image quality

M. EMERGENCY SERVICES - In the event emergency services are required, the contractor shall respond to all sites at the same time if necessary, within 3 hours. The COR will notify the contractor. A Firm Fixed Price proposal shall be submitted to the Contracting Officer within 24 hours to negotiate, definitized, and complete based on the labor mix table attached. The proposal shall include details as to the extent of the emergency to enable the Government to evaluate the proposal and eventual price. At a minimum, each proposal shall include:

1. Brief description of the emergency and why it is required

2. Categorical Labor Hours break-down to accomplish required effort N. 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 agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Bay Pines VA Healthcare System records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their Bay Pines VA Healthcare System contract.

4. 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 in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Bay Pines VA Healthcare 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 Bay Pines VA Healthcare System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Bay Pines VA Healthcare System. The agency 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. 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 Bay Pines VA Healthcare 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. 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 Bay Pines VA Healthcare 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 Bay Pines VA Healthcare System policy.

8. The Contractor shall not create or maintain any records containing any non-public Bay Pines VA Healthcare System 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 Bay Pines VA Healthcare 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 Bay Pines VA Healthcare 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 [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

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

O. Records Management Obligations

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

VA INFORMATION CUSTODIAL LANGUAGE:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

c. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

d. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

SECURITY INCIDENT INVESTIGATION:

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

SECURITY CONTROLS COMPLIANCE TESTING :

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

P. ISO/PO Comments:

The following language from VA Handbook 6500.6 is required in this contract:

· Appendix C: #3a, b, c, d, e, f, j, k, #6a, b, d, #7(all), #9(all)

3. VA Information Custodial Language:

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of…