36C24919Q0458-001.docx

36C24919Q0458

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24919Q0458 09-24-2019 David Milner 615-225-6543 10-14-2019 12:00pmCT 90C Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129 X 541690 $15 Million N/A X Department of Veterans Affairs

MEMPHIS VAMC

1030 JEFFERSON AVE

MEMPHIS TN 38104

90C Department of Veterans Affairs Network Contracting Office - 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

90C FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135 See CONTINUATION Page The Memphis VAMC is seeking a Contractor to accomplish on-site diagnostic physics surveys of radiation producing machines and other diagnostic machines per the Performance Work Statement located in Section B.3.

Please review Addendum to FAR 52.212-1 for quoters instructions.

See CONTINUATION Page X X David B. Milner, Jr.

Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C249 David B. Milner, Jr.

Department of Veterans Affairs Network Contracting Office 9 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

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

B.2 PRICE/COST SCHEDULE

The Contractor shall furnish all necessary travel, labor, material, supplies, tools, equipment, documentation, and qualified personnel to provide on-site diagnostic support or services for the Veterans Health Administration (VHA) located at the Veterans Affairs Medical Center, 1030 Jefferson Ave., Memphis, TN 38104.

The IDIQ maximum amount is $650,000.00

The IDIQ minimum guaranteed amount is $59,000.00

Ordering Periods: The contract will have five ordering periods as listed in the price schedule below. Task orders may only be placed by NCO-09 contracting officers.

The contractor shall only invoice for actual jobs accomplished. The estimated quantities listed in the Table below are not guaranteed amounts.

In addition to filling out the PRICE/COST Schedule, the contractor shall also submit the Price worksheet, See Section D.

ITEM INFORMATION

Ordering Period 1: October 21, 2019 through October 20, 2020

Testing of radiation producing equipment (radiographic). (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (Dental). (Estimated quantity each year)

Diagnostic physics testing of ultrasound equipment. (Estimated quantity each year)

Diagnostic physics testing of the dental cone beam CT. (Estimated quantity each year)

Diagnostic physics testing of radiation equipment (DEXA). (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (CT). (Estimated quantity each year)

Diagnostic physics tesing of MRI machines. (Estimated quantity each year)

Diagnostic physics testing of the CR Reader and Imaging Plates. (Estimated quantity each year)

Diagnostic physics testing of the nuclear medicine camera. (Estimated quantity each year)

Diagnostic physics testing of the PET scanner in the nuclear medicine Department. (Estimated quantity each year)

Diagnostic physics testing of portable fluoroscopy machines (C-arm)

Review CT Quality Assurance (including CT protocols) & Dosimetry Program

Accomplish shielding design evaluation/calculations

Perform a radiation safety survey

Ordering Period 2: October 21, 2020 through October 20, 2021

Testing of radiation producing equipment (radiographic). (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (Dental). (Estimated quantity each year)

Diagnostic physics testing of ultrasound equipment. (Estimated quantity each year)

Diagnostic physics testing of the dental cone beam CT. (Estimated quantity each year)

Diagnostic physics testing of radiation equipment (DEXA) (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (CT) (Estimated quantity each year)

Diagnostic physics tesing of MRI machines (Estimated quantity each year)

Diagnostic physics testing of the CR Reader and Imaging Plates (Estimated quantity each year)

Diagnostic physics testing of the nuclear medicine camera. (Estimated quantity each year)

Diagnostic physics testing of the PET scanner in the nuclear medicine Department. (Estimated quantity each year)

Diagnostic physics testing of portable fluoroscopy machines (C-arm)

Review CT Quality Assurance (including CT protocols) & Dosimetry Program

Accomplish shielding design evaluation/calculations

Perform a radiation safety survey

Ordering Period 3: October 21, 2021 through October 20, 2022

Testing of radiation producing equipment (radiographic). (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (Dental). (Estimated quantity each year)

Diagnostic physics testing of ultrasound equipment. (Estimated quantity each year)

Diagnostic physics testing of the dental cone beam CT. (Estimated quantity each year)

Diagnostic physics testing of radiation equipment (DEXA) (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (CT) (Estimated quantity each year)

Diagnostic physics tesing of MRI machines (Estimated quantity each year)

Diagnostic physics testing of the CR Reader and Imaging Plates (Estimated quantity each year)

Diagnostic physics testing of the nuclear medicine camera. (Estimated quantity each year)

Diagnostic physics testing of the PET scanner in the nuclear medicine Department. (Estimated quantity each year)

Diagnostic physics testing of portable fluoroscopy machines (C-arm)

Review CT Quality Assurance (including CT protocols) & Dosimetry Program

Accomplish shielding design evaluation/calculations

Perform a radiation safety survey

Ordering Period 4: October 21, 2022 through October 20, 2023

Testing of radiation producing equipment (radiographic). (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (Dental). (Estimated quantity each year)

Diagnostic physics testing of ultrasound equipment. (Estimated quantity each year)

Diagnostic physics testing of the dental cone beam CT. (Estimated quantity each year)

Diagnostic physics testing of radiation equipment (DEXA) (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (CT) (Estimated quantity each year)

Diagnostic physics tesing of MRI machines (Estimated quantity each year)

Diagnostic physics testing of the CR Reader and Imaging Plates (Estimated quantity each year)

Diagnostic physics testing of the nuclear medicine camera. (Estimated quantity each year)

Diagnostic physics testing of the PET scanner in the nuclear medicine Department. (Estimated quantity each year)

Diagnostic physics testing of portable fluoroscopy machines (C-arm)

Review CT Quality Assurance (including CT protocols) & Dosimetry Program

Accomplish shielding design evaluation/calculations

Perform a radiation safety survey

Ordering Period 5: October 21, 2023 through October 20, 2024

Testing of radiation producing equipment (radiographic). (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (Dental). (Estimated quantity each year)

Diagnostic physics testing of ultrasound equipment. (Estimated quantity each year)

Diagnostic physics testing of the dental cone beam CT. (Estimated quantity each year)

Diagnostic physics testing of radiation equipment (DEXA) (Estimated quantity each year)

Diagnostic physics testing of radiation producing equipment (CT) (Estimated quantity each year)

Diagnostic physics tesing of MRI machines (Estimated quantity each year)

Diagnostic physics testing of the CR Reader and Imaging Plates (Estimated quantity each year)

Diagnostic physics testing of the nuclear medicine camera. (Estimated quantity each year)

Diagnostic physics testing of the PET scanner in the nuclear medicine Department. (Estimated quantity each year)

Diagnostic physics testing of portable fluoroscopy machines (C-arm)

Review CT Quality Assurance (including CT protocols) & Dosimetry Program

Accomplish shielding design evaluation/calculations

Perform a radiation safety survey

B.3 PERFORMANCE WORK STATEMENT (PWS)

Diagnostic Physics Services The Contractor shall furnish all necessary travel, labor, material, supplies, tools, equipment, documentation, and qualified personnel to provide on-site diagnostic support or services for the Veterans Health Administration (VHA) located at the Veterans Affairs Medical Center, 1030 Jefferson Ave., Memphis, TN 38104, under the terms and conditions stated herein.

This contract shall be in accordance with all terms, conditions, provisions, schedules, and specifications of this solicitation. The contract shall be for a period of one year and four additional ordering periods.

1. Performance

A. All radiation diagnostic physic work shall be performed by a qualified diagnostic radiation physicist. A qualified diagnostic physicist is a person who is certified by the American Board of Radiology (ABR), American Board of Medical Physics (ABMP), or the Canadian College of Physicists in Medicine. The physicist shall present their Board Certifications upon arrival.

B. The estimated quantity of diagnostic physics surveys of radiation producing machines and other diagnostic machines is 110 machines annually.

2. Mandatory Services to be Performed - Deliverables A. The qualified diagnostic physicist shall perform imaging equipment (x-ray equipment, nuclear medicine cameras, PET/CT cameras, ultrasound units, and MRIs) surveys to ensure compliance with the current American College of Radiology (ACR). In the absence of ACR guidance, other industry standards will be utilized.

B. Any deficiencies or non-conformances discovered shall be verbally communicated to the Chief of the Biomedical Department and to the Radiation Safety Officer prior to the Contractor leaving the facility.

C. A diagnostic physics report will be supplied to the Radiation Safety Officer within 30 calendar days after services are provided. The report format and required information will be in accordance with the ACR guidelines and industry standards.

D. Any contractor that works on station must complete the VHA Privacy and HIPAA training prior to arriving on station and provide documentation of completed training. In order for any contractor to engage in work at VA, he/she is required to ensure all contractors who will be working on the contract complete a mandatory training program titled VA Privacy and Information Security Awareness Training and Rules of Behavior (10176) as well as VHA Privacy and HIPAA Training (10203). This training is offered through the VA Talent Management System (TMS), a system that offers web-based training to VA employees and its partners. He/she must ensure each contract employee self-enrolls for a profile on the VA TMS 2.0 by visiting https://www.tms.va.gov/secureauth35/. Once there, employees should follow the steps to create a profile, launch the mandatory training, and complete the content prior to their next day at VA. Upon completion by all employees, the contractor shall provide their Contracting Officer Representative with each employee’s printed certificate of completion from the TMS 2.0. This certificate displays the employee’s TMS User ID. The COR shall be contacted if further instructions on completion of this training are needed.

E. The Contractor (or representative) will wear his or her issued VA ID badges at all time while on duty facing forward above the waist. In addition, no photographs, videos, or recordings will be made while on VA premise as such activities are prohibited. The contractor will report to the Radiation Safety Office located in room G-138 during normal working hours for instruction. The contractor will be escorted by a VA employee in patient care areas to protect sensitive information.

F. The qualified diagnostic physicist shall perform a full inspection of imaging equipment after repairs or modifications that may affect the radiation output or image quality. The inspection shall be completed within 30 calendar days after the facility contacts the contractor. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the Chief of Biomedical or RSO prior to the qualified diagnostic 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.

G. The qualified diagnostic physicist shall provide shielding design evaluation/calculations and radiation safety survey for each new, replaced, or relocated x-ray imaging system, if requested for new radiation machine installations. The calculations for each shall comply with the National Council for Radiation Protection and Measurements (NCRP) Report No. 147, and, for dental units, NCRP Report No. 145, and shall be documented in a written report which includes a diagram showing adjacent areas. The qualified diagnostic physicist shall perform a shielding safety survey to verify the structural shielding was installed per the shielding design report and complies with the design goals. A written report of the shielding survey shall be provided to the Chief of Biomedical or RSO within 30 calendar days after the shielding survey has been completed.

H. If requested, the qualified diagnostic physicist shall perform a follow-up inspection of equipment to verify compliance of any necessary corrective action performed to correct deficiencies found.

Other Detailed Requirements 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. 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 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) Timer accuracy.

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

(13) Fluoroscopic entrance exposure. Maximum output for all clinically used settings.

(14) Image receptor entrance exposure.

(15) Equipment radiation safety functions.

(16) Patient dose monitoring system calibration.

(17) Video and digital monitor performance.

(18) Digital image receptor performance.

(19) Grids used with portable x-ray units shall be imaged for uniformity.

B. Computed Radiography (CR) and Digital Radiography (DR)

Physics inspections of CR and DR equipment shall comply with the American Association of Physicist in Medicine (AAPM) Report Number 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems. The performance of CR and DR must be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Component and Imaging Plate Physical Inspection and Inventory.

(2) Imaging Plate Dark Noise and Uniformity.

(3) Exposure Indicator Calibration.

(4) Linearity and Auto-ranging Response.

(5) Laser Beam Function.

(6) Limiting Resolution and Resolution Uniformity.

(7) Noise and Low-Contrast Resolution.

(8) Spatial Accuracy.

(9) Erasure Thoroughness.

(10) Aliasing/Grid Response.

(11) IP Throughput.

(12) Positioning and Collimation Errors.

C. CT Scanners

The physics inspection shall conform to the 2012 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) Image Thickness – Axial Mode.

(4) Table Travel Accuracy.

(5) Radiation Beam Width.

(6) Low-Contrast Performance.

(7) Spatial Resolution.

(8) CT Number Accuracy.

(9) Artifact Evaluation.

(10) CT Number Uniformity.

(11) Dosimetry (the scanner displayed CTDIvol values must be within +/- 20% of the measured CTDIvol values).

(12) Grey Level Performance of CT Acquisition Display Monitors.

D. 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) Collimation.

(2) Beam quality (half value layer).

(3) Timer Accuracy and Reproducibility.

(4) kVp Accuracy and Reproducibility.

(5) mA or mAs Linearity.

(6) Exposure Reproducibility.

(7) Entrance Skin Exposure Evaluation.

(8) Technique Chart Evaluation.

(9) Image uniformity (artifact evaluation).

E. Dental CBCT Performance Testing

1. 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. and after repairs to the CBCT unit that may affect the radiation output or image quality.

i. Radiation output Repeatability Make four measurements of the air kerma at the isocenter at a clinically used setting. The measurements should be less than +/-5% of the average of the five measurements and the measurements should be less than +/- 5% of the previous year’s measurement.

ii. Radiation Output Reproducibility Measure the air kerma at the isocenter for each kVp station and a range of clinically used mAs setting. Compare the results to the baseline values established at the initial acceptance testing. The values should be +/-5% of the baseline.

iii. kVp Accuracy Measure the kVp at all clinically used settings. The measured kVp should be +/-5% of the selected kVp.

iv. kVp Repeatability Make five kVp measurements each for two clinically used kVp settings. All measured values should be +/-5% of the mean kVp.

v. kVp Reproducibility Measure the kVp at all available kVp settings. The measured values should be +/-5% of the baseline.

vi. Beam quality Measure the half value layer (HVL) for aluminum. The minimum shall comply with Section F.4.d of the Suggested State Regulations for Control of Radiation, Conference of Radiation Control Program Directors.

vii. Radiation field of view (FOV) Measure the width of the radiation field at the isocenter. The width of the beam should be 3 mm or 30% of the total nominal collimated width.

viii. Image Quality Image the phantom provided by the manufacturer or another suitable phantom. Assess high contrast spatial resolution, uniformity of transaxial images, and image noise. Imaging uniformity shall be assessed over the entire range of axial images.

ix. Accuracy of Linear Measurements Using images of an appropriate phantom, assess the accuracy of distance measurements.

x. Accuracy of Patient Dose Metric Indication Assess the accuracy of the indicated dose metric (typically DAP).

xi. Patient Dose Assessment From a scan or scans using the facility’s standard techniques, record the dose metric (typically DAP) and compare to achievable levels and diagnostic reference levels (if available)

F. MRI

The physics inspection shall conform to the 2004 ACR Magnetic Resonance Imaging Quality Control Manual. The performance of each MRI scanner shall be evaluated at least annually. 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

G. PET

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 annually. For PET/CT units the CT must be inspected at least annually per Item C above. 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 performance of each nuclear medicine scanner shall be at least annually. This evaluation should include, but not be limited to, the following tests (as applicable). A review of department quality assurance records pertaining to nuclear medicine equipment shall be reviewed for adequacy at least annually.

(1) Intrinsic Uniformity: fail criteria: > 5.0%

(2) System Uniformity: fail criteria: > 5.0%

(3) Intrinsic or System Spatial Resolution: fail criteria: > 3.5 mm bars

(4) Relative Sensitivity: fail criteria: COV > 2.5%

(5) Energy Resolution: fail criteria: > 12%

(6) Count Rate Parameters: fail criteria

(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. Testing should be done using two transducers commonly used with any unit employing more than one transducer. Data should be taken from testing of the transducers which are used for the most frequently occurring examination(s) at the site. It is recommended that these be of different scan formats such as one linear (or curvilinear array), and one sector (mechanical, phased, or vector).

(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

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. Assess the viewing conditions for the area in which the monitor used to evaluation the CBCT studies is located.

Display Monitors – Minimum Criteria

Perform a visual analysis of the SMPTE test pattern.

1. Display the test pattern on the imaging console. Set the display window width/level to the manufacturer-specified values for the pattern. Do not set the window/level by eye; doing so invalidates the procedure.

1. Examine the pattern to confirm that the gray level display in the imaging console is subjectively correct.

1. Review the line pair patterns in the center and at each of the corners.

1. Review the black-white transition.

1. Look for any evidence of “scalloping” (loss of bit depth) or geometric distortion.

1. Use a photometer to measure the maximum and minimum monitor brightness (0% and 100% steps)

1. Measure additional steps within the pattern to establish a response curve.

1. Measure the brightness near the center of the monitor and near all 4 corners (or all 4 sides, depending on the test pattern used).

K. Quality Assurance Program Technical Review.

The qualified expert shall review the technical QA program. The review shall include a trend analysis of the QA data; in particular, CT protocols and dosimetry program. The results of the technical QA program review shall be included in the written report. Any trends that identify problems shall be included in the report along with recommended corrective actions.

3. Information Security Considerations A. The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required.

B. The appropriate risk associated with PDAT is considered Low and to protect VA sensitive information a Business Associate Agreement (BAA) will not be required. A VA staff escort will accompany the contractor to ensure that no sensitive information is compromised.

C. The security impact of the IT system is low, since the contractor will not be connecting any device to any VA IT system.

D. The C&A requirements do not apply, and a Security Accreditation Package is not required.

E. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in the performance of administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA contracting officer.

F. If the 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 terminate the contract for cause or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

G. Except for used and discourse of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court or competent jurisdiction, or (ii) with VA’s prior written approval. The contractor must refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA contracting officer for response.

H. VA prohibits the installation and use of personally-owned or contractor owned equipment or software on the VA’s network.

I. All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSPs) and Authorities to Operate (ATOs) for all systems/Local Area Networks accessed while performing the tasks detailed in this PD.

J. A prohibition on unauthorized disclosure: “Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.” See VA handbook 6500.6, Appendix C, paragraph 3.a. which can be accessed via the following link: http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2

K. A requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the Contracting Officer’s Representative (COR) (if assigned) the designated Information Security Officer, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

L. A requirement to pay liquidated damages in the event of a data breach: “In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals.” See VA handbook 6500.6, Appendix C, paragraph 7.a., 7.d.

M. A requirement for annual security/privacy awareness training: “Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within one (1) week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA’s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA’s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in the VA’s contract have received their annual security/privacy training that meets VA’s requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

N. A requirement to sign VA’s Rules of Behavior: “Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on annual basis an acknowledgement that they have read, understand, and agree to abide by VA’s Contractor Rules of Behavior which is attached to this contract.” See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor’s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA’s information and information systems.

O. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

P. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

Q. 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.

R. 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.

S. 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.

T. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

U. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

V. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

4. VA Information Custodial Language

36C24919Q0458

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SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.211-11 LIQUIDATED DAMAGES—SUPPLIES, SERVICES, OR RESEARCH AND DEVELOPMENT (SEPT 2000)

(a) If the Contractor fails to deliver the supplies or perform the services within the time specified in this contract, the Contractor shall, in place of actual damages, pay to the Government liquidated damages of $37.50 per calendar day of delay.

(b) If the Government terminates this contract in whole or in part under the Default—Fixed-Price Supply and Service clause, the Contractor is liable for liquidated damages accruing until the Government reasonably obtains delivery or performance of similar supplies or services.