36C25719Q0642-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Q Physics Services for the North Texas Health Care System 75137 36C25719Q0642 05-01-2019 N 541690 Department of Veterans Affairs NCO 17- RPO West NCO 17 Network Contracting Activity 124 E. Hwy 67 Duncanville, Texas 75137 Rastreva Upshaw, Contract Specialist Rastreva.Upshaw@va.gov Victoria Rone, Contracting Officer Victoria.Rone3@va.gov Department of Veterans Affairs North Texas Health Care System Dallas VA Medical Center 4500 S. Lancaster Road Dallas, Texas 75216

USA

See Emails Listed Above This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Solicitation; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C25719Q0642 is issued as a Request for Quotation (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular.

SET-ASIDE: This requirement is a Total Small Business Set-Aside, the NAICS is 541690 and the small business size standard is $15 Million. In order to be eligible an offeror must be small for the applicable NAICS code at the time of the quote submission and at the time of award. Only qualified offerors may submit bids.

Introduction: A Firm Fixed Price award will be made to the lowest priced quote which conforms to the requirements within this solicitation and represents the best price to the Government.

Description of Services: The Contractor shall provide all personnel, supervision, transportation, equipment as outlined in the Statement of Work. See the Statement of Work for full details.

Place of Performance: Department of Veterans Affairs Medical, North Texas Health Care System, 4500 Lancaster Road, Dallas, Texas, 75216.

Type of Contract: A Firm Fixed Price – Base Plus Four Option Year Renewals Period of Performance:

The following clauses and provisions apply to this solicitation:

52.209-5, Certification Regarding Responsibility Matters

52.212-3, Offeror Representations and Certifications-Commercial Items

52.212-4, Contract Terms and Conditions-Commercial Items

52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items 52.217-8, Option to Extend Services

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days.

“Evaluations of Options (July 1990)”

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by using the prices offered for the last option period to determine the price for a 6-month option period, which will be added to the base and other option years to arrive at the total price. Evaluation of options will not obligate the Government to exercise the option(s).

(End of Clause)

52.217-9, Option to Extend the Term of the Contract

a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 (five) years.

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days.

52.203-17 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Right 52.203-99 Prohibition of Contracting with Entities That Require Certain Internal Confidentiality Agreements 52.219-14, Limitations on Subcontracting 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3).

52.222-3, Convict Labor 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving 52.228-5 Insurance-Work on a Government Installation (JAN 1997)

52.232-33, Payment by Electronic Funds Transfer-System for Award Management 52.237-3 Continuity of Services (JAN 1991)

52.232-39, Unenforceability of Unauthorized Obligations (In the FAR https://www.acquisition.gov/far/html/52_232.html#wp1160005) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) 52.233-3, Protest after Award (In the FAR https://www.acquisition.gov/far/html/52_233_240.html) 852.203-70, Commercial Advertising (JAN 2008) 852.232-72, Electronic Submission of Payment Requests

852.237-70, Contractor Responsibilities

52.252-1, Solicitation Provisions Incorporated by Reference:

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es).

52.252-2, Clauses Incorporated by Reference:

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es). Full text can be obtained at http://www.acquisition.gov/far/index.html

852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018)

LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE

(a) This solicitation includes far 52.219-6, Notice of Total Small Business Set-Aside.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

(End of clause)

852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE. AS PRESCRIBED IN 819.7203(C) INSERT THE FOLLOWING CLAUSE: SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

(a) This contract includes FAR 52.219-9, Small Business Subcontracting Plan, and VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirement.

(b) Accordingly, any contract resulting from this solicitation will include these clauses, unless the contract is awarded to a small business concern. The Contractor is advised in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing the Contractor's compliance with the plan, including reviewing the Contractor's accomplishments in achieving the subcontracting goals in the plan. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding the Contractor's compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting plan.

(End of clause)

SUBMISSION OF QUOTE (FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS):

The Offeror shall submit their quote on company letterhead and shall include unit price, overall total price, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov. Complete copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document.

The offeror shall provide sufficient evidence that they possess adequate resources, capability, experience, responsibility and integrity to meet the technical capabilities to comply with the requirements of the resulting contract. All quotes received without this documentation will not be considered.

Quotes must be received no later than Wednesday, May 1, 2019, 11:00 am CST. Email your quote to Rastreva.Upshaw@va.gov and Victoria.Rone3@va.gov. The subject line must specify 36C25719Q0642 Physics Services (NTX). There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered.

These services are subject to the Service Contract Act and Wage and Determination (WD 15-5227 Rev.-7) which was first posted on www.wdol.gov on 01/01/2019 and can be assessed at https://www.wdol.gov/wdol/scafiles/std/15-5227.txt?v=6.

Quote should be broken down as follows:

PRICE/COST SCHEDULE

ITEM INFORMATION

Contract for Physics Services Contract Period: Base May 17, 2019 – May 16, 2020

Contract for Physics Services Contract Period: Option Year One May 17, 2020 – May 16, 2021

Contract for Physics Services Contract Period: Option Year Two May 17, 2021 – May 16, 2022

Contract for Physics Services Contract Period: Option Year Three May 17, 2022 – May 16, 2023

Contract for Physics Services Contract Period: Option Year Four May 17, 2023 – May 16, 2024

CONTRACT GRAND TOTAL $ _________________

SIX- MONTH EXTENSION - PRICE/COST SCHEDULE

Six Month Extension May 17- 2024 - November 16, 2024

SIX-MONTH EXTENSION TOTAL $ _________________

The solicitation package will be posted on FedBizOpps, which can be accessed at www.fedbizopps.gov. The Government will not provide paper copies of the solicitation. Telephone, written, or facsimile, requests, for the solicitation package will not be honored. All interested parties MUST be registered in the System for Award Management (SAM) Database and have completed On-Line Representation and Certifications Application (ORCA) in order to receive a contract award. If you are not registered with SAM, you may request an application via phone at 866-606-8220 or register on-line at https://www.sam.gov. To keep informed of changes: Check www.fedbizopps.gov frequently.

DISCLAIMER AND IMPORTANT NOTES: The government is in no way obligated to do business with or enter into the award a contract to any firm or its affiliates or otherwise pay for the information provided in this synopsis.

STATEMENT OF WORK

I. Description of Services.

1. Scope of Work. The Contractor shall provide all personnel, transportation, equipment (including the ACR phantoms necessary for quality assurance testing) and software to provide diagnostic medical physics services in support of the Veterans Affairs North Texas Health Care System (VANTHCS) by performing the following tasks:

· Task 1: Annual quality assurance testing of all diagnostic x-ray and imaging equipment (to include MRI and Ultrasound systems). See Attachments A and B for list of equipment. These lists are subject to change as equipment is replaced and new locations are opened for clinical services with new equipment. [TJC, NHPP]

· Task 2: Annual quality assurance testing of mammography equipment. Recertification of equipment when required. [MQSA]

· Task 3: Required physics testing of diagnostic x-ray and imaging equipment following repairs that could affect patient dosimetry and/or image quality, as needed. [TJC, NHPP]

· Please use the following assumptions to make a bid on this task. Cost to provide physics testing within two days of notification by RSO following major repair for:

· CT unit

· Full Field Digital Mammography unit

· Mammography reading workstation

· Radiography unit

· R&F unit

· Dental unit

· Task 4: Consulting services to support the VANTHCS Radiation Safety Office.

· Consulting services include but are not limited to:

· Attend appropriate VANTHCS committee meetings (i.e., Radiation Safety Committee, CT Protocol Committee, Fluoroscopy Safety Subcommittee, Patient Dosimetry Subcommittee) on a quarterly or as needed basis. [TJC]

· Review of VANTHCS overall technical quality assurance program for diagnostic x-ray and imaging equipment. [NHPP]

· Perform patient dose evaluations, including fetal exposures, as needed and maybe on an urgent basis. When applicable, the Radiology Service QA ADPACs will ensure proper redaction of the patient’s PHI (i.e., when imaging studies are needed for dose evaluation)

· Perform personnel occupational dose evaluations, as needed.

· Please use the following assumptions to make a bid on this task. Cost to provide 4 hours per month of consulting services.

· Task 5: Initial installation quality assurance testing of all new diagnostic x-ray and imaging equipment (to include MRI and Ultrasound systems) on an as needed basis. See Attachment C for list of equipment. This list is subject to change. [NHPP]

· Task 6: Initial installation quality assurance testing of new mammography equipment on an as needed basis. [MSQA]

· Task 7: Complete structural shielding design plans for the installation of new diagnostic x-ray and imaging equipment at VANTHCS. This task is to be completed on an as-needed basis in cases where the structural shielding design plan is not addressed by VANTHCS Engineering Service. [TJC, NHPP]

· Task 8: Complete radiation protection surveys to verify the adequacy of installed shielding for new and/or refurbished rooms or replacement of equipment. [TJC, NHPP]

· Task 9: Written reports signed by the diagnostic medical physicist documenting the shielding design calculations and acceptance testing of the structural shielding. Written reports signed by the diagnostic medical physicist documenting the quality assurance testing, including a summary of methods, instruments used, measurements and deficiencies identified, for all diagnostic x-ray and imaging equipment. Each written report will identify the x-ray and/or imaging equipment using the following information at a minimum: VANTHCS EE number and the equipment’s location (VANTHCS facility, building, and room number). The Contractor shall provide two (2) copies of the physicist report to the RSO and the Chief of Biomedical Services within thirty days of completion of the work. The report may be in electronic format. [TJC, NHPP]

· Task 10: Deficiencies or non-conformances which represent unsafe conditions shall be reported to the RSO immediately. Verbal reports must be provided after testing so that VANTHCS will know that equipment can be immediately put into use.

The diagnostic medical physics services will include all x-ray and imaging equipment at VANTHCS facilities, including Dallas VA Medical Center, Fort Worth VA Outpatient Clinic, Sam Rayburn Memorial Veterans Center in Bonham, Plano VA Outpatient Clinic. Other VANTHCS facilities may be added to this list if and/or when x-ray and imaging equipment are added to existing and new facilities. All quality assurance testing reports, mammography equipment performance evaluations reports, shielding designs, and radiation protection surveys shall be submitted to the VANTHCS 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 VA North Texas Health Care System(VANTXHCS) and must be returned to VANTXHCS at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1.”

1.1. Quality Assurance Testing

1.1.1. All Quality Assurance Tests shall meet or exceed NRC, ACR, MQSA, NCRP, FDA, TJC requirements and recommendations, and the Conference of Radiation Control Program Director’s (CRCPD) Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays and Imaging Systems in the Healing Arts or current document. All Quality Assurance Tests shall meet or exceed the requirements in the following VHA directives and handbooks:

· VHA Directive 1105, Management of Radioactive Materials

· VHA Directive 1105.02, Nuclear Medicine and Radiation Safety Administrative Service

· VHA Directive 1105.03, Mammography Program Procedures and Standards

· VHA Directive 1105.04, Fluoroscopy Safety

· VHA Directive 1105.05, MRI Safety

· VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation

1.1.2. Diagnostic X-ray Equipment (Radiography)

The testing must include, but is not necessarily limited to, the following (as applicable):

Per CRCPD Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays and Imaging Systems in the Healing Arts:

· Image artifacts

· Spatial resolution

· Contrast/noise

· Workstation monitors

· Exposure indicator constancy

Per the American College of Radiology (ACR-AAPM) Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic Equipment (2016):

· Visual equipment checklists

· Integrity of unit assembly

· Operation of alerts and interlocks

· Other radiation safety functions

· Acquisition display monitor(s) performance

· Image artifacts

· Appropriateness of adult protocols

· Radiation field size measurement

· Collimation and radiation beam alignment

· Automatic collimation accuracy

· Light beam and bucky alignment

· Air kerma or exposure (radiation output)

· Displayed radiation metrics accuracy

· Exposure reproducibility

· Tube potential (kVp) accuracy and reproducibility

· Linearity of exposure versus mA or mAs

· Timer accuracy

· Minimum beam quality (half-value layer)

· Radiographic patient entrance exposure for a “typical” adult patient

· Automatic exposure control

· Image quality: system high contrast resolution

· Image quality: system low contrast resolution

· Repeat analysis

· CR/DR exposure log analysis

· PACS adequacy

1.1.3. Diagnostic X-ray Equipment (Fluoroscopy)

The testing must include, but is not necessarily limited to, the following (as applicable):

Per the TJC Standards Revisions for Organizations Providing Fluoroscopy Services (Issued June 25, 2018):

· Beam alignment and collimation

· Tube potential/kilovolt peak (kV/kVp) accuracy

· Beam filtration (half-value layer)

· High-contrast resolution

· Low-contrast detectability

· Maximum exposure rate in all imaging modes

· Displayed air-kerma rate and cumulative-air kerma accuracy (when applicable)

Per CRCPD Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays and Imaging Systems in the Healing Arts:

· A measurement of entrance exposure rates that covers the full range of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction and CINE, when available. These measurements shall:

· For systems without automatic exposure control, be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

· For systems with automatic exposure control, be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

· A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with Sec F.5e.iv.

· An evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes

· An evaluation of the operation of the 5-minute timer, warning lights, interlocks, and collision sensors.

· An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.

· An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.

· An evaluation of any changes that may impact patient and personnel protection devices.

Per the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Fluoroscopic Equipment (2016):

· Visual equipment checklists

· Integrity of unit assembly

· Operation of alerts and interlocks

· Other radiation safety functions

· Appropriateness of protocols (fluoroscopic and acquisition) – for selected uses

· Radiation field size measurement

· Acquisition display monitor(s) performance

· Collimation and radiation beam alignment

· Tube potential (kVp) accuracy and reproducibility

· Minimum beam quality (half-value layer) – for selected uses

· Image quality: system high contrast resolution

· Image quality: system low contrast resolution

· Displayed radiation metrics accuracy

· Image receptor air kerma rate – for selected uses (Image Intensifiers)

· Patient entrance air kerma rate for a “typical” adult patient – for selected uses

· Maximum patient entrance air kerma rate

· Image receptor performance

· Image artifacts

· PACS adequacy

1.1.4. Computed Tomography

The testing must include, but is not necessarily limited to, the following (as applicable):

Per the TJC Standards Revisions for Organizations Providing Fluoroscopy Services (Issued June 25, 2018) and Per the TJC Diagnostic Imaging Requirements (Issued August 10, 2015):

· Image uniformity

· Scout prescription accuracy

· Alignment light accuracy

· Table travel accuracy

· Radiation beam width

· High-contrast resolution

· Low-contrast detectability

· Geometric or distance accuracy

· CT number accuracy and uniformity

· Artifact evaluation

· Dosimetry

· The diagnostic medical physicist measures the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following four CT protocols: adult brain, adult abdomen, pediatric brain and pediatric abdomen. If one or more of these protocols is not used by the hospital, other commonly used CT protocols may be substituted.

· The diagnostic medical physicist verifies that the radiation dose (in the form of CTDIvol) displayed by the CT imaging system for each tested protocol is within 20 percent of the CTDIvol displayed on the CT console. The dates, results, and verifications of these measurements are documented.

· Image acquisition display monitors

· Maximum luminance

· Minimum luminance

· Luminance uniformity

· Resolution

· Spatial accuracy

Per CRCPD Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays and Imaging Systems in the Healing Arts:

· Geometric factors and alignment including:

· Alignment light accuracy

· Table increment accuracy

· Image localization from scanned projection radiograph (localization image)

· Radiation beam width

· Image quality including:

· High-contrast (spatial) resolution

· Low-contrast resolution

· Image uniformity

· Noise

· Artifact evaluation

· CT number accuracy

· Image quality for acquisition workstation display devices

· A review of the results of the routine QC required under F.11a.iii

· A safety evaluation of audible and visual signals, posting requirements

· Dosimetry

Per the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment (2017):

· Alignment light accuracy

· Image localization from scanned projection radiograph (localization image)

· Table travel accuracy

· Radiation beam width (collimation)

· Image quality

· High-contrast (spatial) resolution

· Low-contrast sensitivity and resolution

· Image uniformity

· Noise

· Artifact evaluation

· CT number accuracy

· Acquisition workstation display

· Radiation output or dosimetry

· Measurement of radiation output of CT scanner (CT dose index [CTDIvol] or other metric accepted by a nationally recognized organization)

· Measurement of doses for verification of scanner performance and to allow for calculation of dosimetric quantities relevant to patient examination estimates

· Comparison of calculated values to scanner-reported values. These comparisons should include both 16-cm and 32-cm dosimetry phantoms, as appropriate for the CT system and for use with the indicated protocols.

· Limited protocol review

· The Diagnostic Medical Physicist must review a selection of the most commonly used protocols. These should include head and abdomen protocols for adult and pediatric patients as applicable to the facility’s practice. In addition, facility protocols for very high dose procedures (e.g., brain perfusion) should be reviewed.

· The key elements associated with image quality and patient dose should be reviewed. These should include, but are not limited to:

· kVp

· mA

· Rotation time

· Detector configuration

· Pitch

· Reconstructed image thickness

· Appropriate use of automated settings, such as tube current modulation, kVp selection, and image reconstruction parameters

· Accuracy of indicated CTDIvol

· When possible, CTDIvol should be compared to established reference values

· Safety Evaluation

· Visual inspection

· Workload assessment

· Scatter and stray radiation measurements (if work load and other related parameters have changed since acceptance testing)

· Audible/visual signals

· Posting requirements

· Other tests as required by state or local regulations

1.1.5. MRI Equipment

The testing must include, but is not necessarily limited to, the following (as applicable):

Per the TJC Diagnostic Imaging Requirements (Issued August 10, 2015):

· Image uniformity for all radiofrequency (RF) coils used clinically

· Signal-to-noise ratio (SNR) for all coils used clinically

· Slice thickness accuracy

· Slice position accuracy

· Alignment light accuracy

· High-contrast resolution

· Low-contrast resolution (or contrast-to-noise ratio)

· Geometric or distance accuracy

· Magnetic field homogeneity

· Artifact evaluation

· Image acquisition display monitors

· Maximum luminance

· Minimum luminance

· Luminance uniformity

· Resolution

Per the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Magnetic Resonance Imaging (MRI) Equipment (2014):

· Magnetic field homogeneity

· Slice position accuracy

· Slice thickness accuracy

· Performance testing for coils used clinically

· Coil physical visual inspection

· Transmitter gain/attenuator verification

· Image signal–to-noise ratio (SNR)

· Image artifact assessment

· Image intensity uniformity for all volume coils

· Year-to-year variations of each of the above parameters should be compared and/or tracked

· Phase stability and image artifact assessment for all coils

· Geometric accuracy (gradient calibration)

· High-contrast spatial resolution

· Low-contrast detectability

· Acquisition workstation monitor performance

· Inspection of the physical and mechanical integrity of the system

· Evaluation of technologist quality control (QC) program

· Assessment of the MRI safety program

1.1.6. Ultrasound Equipment

The testing must include, but is not necessarily limited to, the following (as applicable):

Per the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real Time Ultrasound Equipment (2016):

· Physical and mechanical inspection

· Image uniformity and artifact survey

· Fidelity of the ultrasound scanner electronic image display(s)

· Evaluation of the QC program (if applicable)

· System sensitivity

· Geometric accuracy

· Contrast resolution

· Spatial resolution

· Fidelity of the display device(s) used for primary interpretation

· Doppler functionality (Quantitative or qualitative evaluation)

1.2. Structural Shielding

1.2.1. For diagnostic and interventional x-ray equipment, ensure rooms where x-ray equipment is used are shielded per National Council on Radiation Protection and Measurements (NCRP) Report No. 147, Structural Shielding Design for Medical X-ray Imaging Facilities, or current document and documentation demonstrating compliance is maintained. [VHA Directive 1129]

1.2.2. For linear accelerators, ensure structural shielding design reports and shielding surveys conform to NCRP Report No. 151, Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy Facilities, or current document. [VHA Directive 1129]

1.2.3. 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 Directive 1105.04]

1.2.4. Review, prior to construction, plans for rooms in which ionizing radiation producing equipment is to be installed, including room layout, shielding, viewing, and communications systems. Perform radiation surveys after installation but before clinical use of the equipment. NOTE: For any room in which a fluoroscopic imaging system is 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 medical physicist or medical health physicist. [VHA Directive 1105.04]

2.1. Qualifications. Prior to commencing work, all contractor employees shall meet certain criteria to perform work under this contract as a Diagnostic Medical Physicist. Contractor employees shall meet certain criteria to perform MRI quality assurance testing under this contract as a MR Scientist, if the contractor employee does not meet the criteria for 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 VANTHCS Chief of Staff and approval by the VANTHCS Facility Director. VANTHCS requires a copy of qualifications documents for each individual who will perform work at a VANTHCS facility, and VANTHCS must give approval that the individual meets the qualifications before VANTHCS will allow that individual to perform work on x-ray and imaging equipment at VANTHCS.

2.1.1. Diagnostic Medical Physicist:

2.1.1.1. The Diagnostic Medical Physicist who performs the work at VANTHCS shall meet the following education, certification, and qualification standards:

· Hold a Master’s Degree in Medical Physics, Health Physics or a related field.

· Hold current Board Certification by the American Board of Radiology (ABR) or American Board of Medical Physics (ABMP). Appropriate subfield is Diagnostic Medical Physics for ABR certification and Diagnostic Imaging Physics for ABMP certification.

· Licensed by the State of Texas as a Professional Medical Physicist

· Meet all NRC, ACR, MQSA, FDA and TJC requirements for a qualified diagnostic medical physicist,

· Has ten years of experience providing diagnostic medical physics services, following board certification by either ABR or ABMP

· In addition for MRI testing, have performed evaluations of at least 6 MRI systems under the direction of a Qualified Medical Physicist or MR Scientist.

2.1.2. Qualified MR Scientist

2.1.2.1. The Qualified MR Scientist who performs the work at VANTHCS shall meet the following education, certification, and qualification standards:

· Hold a graduate degree in a physical science involving nuclear MR or MRI.

· Have 3 years of documented experience in a clinical MRI environment

2.1.3. The Diagnostic Medical Physicist and/or Qualified MR Scientist shall have current knowledge, understanding, and recent experience in the following:

· Principles of imaging physics and of radiation protection,

· Principles of ultrasound safety and bioeffects,

· All Texas Department of State Health Services, Radiation Control Regulations,

· All current NRC regulations,

· All current FDA regulations (including MQSA),

· Current standards of the ACR and TJC on diagnostic x-ray and imaging equipment,

· Current recommendations of the NCRP and AAPM, including those on medical imaging facility design and shielding,

· The function, clinical uses, and performance specifications of the imaging equipment,

· Current techniques for the calibration and testing of diagnostic x-ray and imaging equipment, including the limitations of the instruments used for testing performance

· For MRI:

· Principles of MRI safety for patients, personnel, and the public,

· FDA guidance for MRI diagnostic devices,

· Knowledgeable in the field of nuclear MR physics and familiar with MRI technology, including the function, clinical uses, and performance specifications of MRI equipment, as well as calibration processes and limitations of the performance testing hardware, procedures, and algorithms.

· Working understanding of clinical imaging protocols and methods of their optimization

· These proficiencies shall be maintained by participation in continuing education programs of sufficient frequency to ensure familiarity with current concepts, equipment, and procedures.

2.1.4. Contractor employees providing services under the supervision of a Diagnostic Medical Physicist is NOT acceptable (e.g., X-ray technologist) and is NOT permitted per VA contract. A physicist in training or a physicist under a temporary license shall be accompanied by and directly supervised by a Diagnostic Medical Physicist meeting the qualifications stated in Section 2.1.1.1.

3. Required Response Time.

Patient access to health care services at VANTHCS facilities is an absolute high priority. VANTHCS requires the contractor to respond and be present at the VANTHCS facility within 2 business days to provide services for those tasks that have the potential to negatively impact patient access to health care services. These tasks include, but are not limited to, the physics/quality assurance testing of diagnostic x-ray and imaging equipment following repairs that could affect patient dosimetry and/or image quality, the recertification of mammography equipment when required, the initial installation quality assurance testing, and the radiation protection surveys. If the contractor cannot or fails to meet the required response time, then VANTHCS reserves the right to seek medical physics services from other vendors not covered under this contract.

4. Subcontracting.

All subcontracting plans shall be submitted as part of the proposal. The contractor shall ensure that the subcontractor meets all the requirements specified in this Statement of Work and all other applicable federal/state regulations and requirements.

5. Travel Expenses.

The contractor shall be responsible for travel expenses for all services performed under this contract.

II. Contractor Personnel Security Requirements - Information Systems Access

Upon contract award, all key personnel 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. If the investigation or screening is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for VA.

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.

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

12.3.3 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.

12.3.4 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. As previously stated, if the investigation or screening is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for VA.

12.3.5 The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the contract person from consideration of working under the contract.

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

Note: Contractor will coordinate all work with Bio-medical engineering department which will grant access to equipment and spaces as necessary IAW established VA work schedule and with the approval of the Bio-medical Engineering Service Chief.

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

III. NARA Records Management

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. VANTHCS 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 VANTHCS 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 VANTHCS. 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 Statement of Work. 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 VANTHCS 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 Statement of Work. 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 VANTHCS 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 VANTHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public VANTHCS 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 VANTHCS 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 VANTHCS 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, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Attachment A List of X-ray and Imaging Equipment at VANTHCS facilities

PROMAX SE

INTRA

INTRA

INTRA

PROMAX

PROMAX

PROMAX

INTRA

(C-arm) General Electric

OEC 9900 ELITE

INTRAORAL

INTRA

ALLURA XPER FD20

INTRA

(C-arm) Philips

BV PULSERA

- Digital General Electric

SENOGRAPHE ESSEN.

INTRA

(C-arm) Siemens Medical

ARCADIS ORBIC

(Simulator) Philips

BRILLIANCE BIG BOR

RADIATION

ONCOLOGY

BC128-2-D

Somatom Definition

Somatom Definition

- Breast Biopsy Hologic Multicare Platinum

(C-arm) General Electric

OEC 9900 ELITE

MEDICAL

(Pulmonary) 5C131-2-D

(Urology OR) Dornier

OPUS II UIMS

(C-arm) General Electric

OEC 9900 ELITE

RADREX-1