36C26119Q0119-002.pdf

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9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

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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

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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 44

662-19-1-147-0001

36C26119Q0119 11-15-2018

Jason T. Hill 925-372-2386 11-20-2018

2:00 PM PST

Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

VA Northern California HealthCare System

150 Muir Road

Martinez CA 94553-4668

X 100

X

541380

$15 Million

N/A

"See Delivery Schedule"

VA Sierra Pacific Network (VISN 21)

VA Northern California HealthCare System

FMS-VA-2(101) Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

This requirement is for the following:

Imaging Equipment Inspection Services

Order #:

Obligation #:

Period of Performance:

12/1/2018 - 11/30/2019

Applicable Wage Determination(s):

(WD-SAN FRANCISCO) - 2015-5637 - Rev. 9 - 05_17_2018

See CONTINUATION Page

X X

Jason T. Hill

Contracting Officer

36C26119Q0119

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.219-14 LIMITATIONS ON SUBCONTRACTING (JAN 2017)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN

2017)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (AUG 2018)

C.4 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.7 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997) . 30

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.10 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.216-1 TYPE OF CONTRACT (APR 1984)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (AUG 2018)

E.3 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(SEP 2018)

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (SEP 2018)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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 36C261 Jason T. Hill

Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

VA Northern California HealthCare System

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly 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.

Department of Veterans Affairs

FMS-VA-2(101) Financial Services Center

PO Box 149971

Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

12.00 MO __________________ __________________

Radiographic and Fluoroscopic Equipment Inspection and Testing

Services

Base Year Period of Performance

12/01/2018 – 11/30/2019

Option Year 1 Period of Performance

12/01/2019 – 11/30/2020

Option Year 2 Period of Performance

12/01/2020 – 11/30/2021

Option Year 3 Period of Performance

12/01/2021 – 11/30/2022

Option Year 4 Period of Performance

12/01/2022 – 11/30/2023

GRAND TOTAL

STATEMENT OF WORK

General

The Contractor shall furnish all materials, supplies, equipment, labor, and qualified personnel to provide on-site diagnostic medical physics support or services for the San Francisco Veterans

Affairs Health Care System (SFVAHCS), under the terms and conditions stated herein, and must adhere to VHA Handbook 1105.04, Fluoroscopy Safety, dated July 6, 2012. The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions, which have the potential to adversely impact the facility radiation workers or patients, to the Radiation Safety Officer (RSO) immediately upon discovery.

1. Performance

All work shall be performed 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 can have state licensure to perform mammography inspections in lieu of board certification. 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

Documented 3 years of clinical experience in CT, nuclear medicine, PET, or MRI. The 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 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 written report of the results shall be provided to the service supervisor or RSO within 5 working days after completion of the inspection. All imaging equipment (except ultrasound, which is semi-annually, and nuclear medicine cameras and PET, which are quarterly) shall be inspected at least annually, 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. The acceptance 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 written report of the results shall be provided to the service supervisor or RSO within 5 working days after completion of the inspection.

c. The qualified diagnostic medical 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 48 hours after the facility contacts the contractor. 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 written report of the results shall be provided to the service supervisor or RSO within five (5) working days after performing of the inspection.

d. The qualified diagnostic medical physicist shall provide consultation for additional services as needed, i.e., safety training, personal protection equipment (PPE) issues.

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

f. The qualified diagnostic medical physicist shall provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations for each system shall comply with the National Council for Radiation Protection and Measurements

(NCRP) Report No. 147, and, for dental units, the NCRP Report No. 145, and shall be documented in a written report which includes a diagram showing adjacent areas. The qualified diagnostic medical physicist shall perform a shielding 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 RSO within five (5) workings days after the shielding survey has been completed.

g. The qualified diagnostic medical physicist shall assist in the development of a comprehensive technical quality assurance (QA) program (e.g., technique charts, repeat/reject analysis monitoring, monitoring of exposure indices to radiographic image receptors, QA program for display monitors, QA for CT, monitoring of dose metrics from fluoroscopy studies), which complies with ACR recommendations, for all modalities.

The qualified diagnostic medical physicist shall review at least annually the QA program.

A written report of the results shall be provided to the service supervisor or RSO within five (5) working days after performing the inspection.

h. The qualified diagnostic medical physicist shall perform a follow-up inspection to verify compliance of any necessary corrective action performed to correct deficiencies found.

3. Equipment Inspections

The Contractor shall conduct equipment inspections or quality control surveys of the imaging equipment listed below. 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.

Estimated Quantities and Locations

Description #

Advanced Imaging Devices / Equipment 13

Rad/Fluoro/Tomo Tubes 22

Minor Radiographic Tubes 22

Garment and PPE checks 600

* Patient dose evaluation is included

1. San Francisco VA Health Care System, 4150 Clement Street, San Francisco, CA 94121

2. Eureka VA Outpatient Clinic, 714 F Street, Eureka, CA 95501

3. Santa Rosa VA Outpatient Clinic, 3841 Brickway Blvd.,Santa Rosa, CA 95403

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 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) Timer accuracy

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

(13) 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.)

(14) 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.)

(15) Image receptor entrance exposure

(16) Equipment radiation safety functions

(17) Patient dose monitoring system calibration. This includes, for radiographic systems, the metric of dose to the image receptor (IEC Exposure Index or proprietary index) and, for fluoroscopy systems, the displays of cumulative air kerma and, if available, DAP.

(18) Display monitor performance

(19) Digital image receptor performance

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

(21) For radiographic units, measurement of entrance skin exposure (or air kerma) for a standard size patient for common radiographic projections and comparison to published diagnostic reference levels and achievable doses (e.g., ACR practice parameter)

Note: The information on entrance exposure rates (or air kerma rates) from fluoroscopy and from fluorography, in Items (13) and (14) above, for each fluoroscope, shall be in a format suitable for providing to the physicians who operate the fluoroscope.

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 Photo-stimulable 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) Gray 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 or every 2 years. 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, with comparison to published diagnostic reference levels and achievable doses (e.g., NCRP Report No. 172)

(8) Technique Chart Evaluation

(9) Image uniformity (artifact evaluation)

Dental CBCT Acceptance and Performance Testing

1. Acceptance Testing. Acceptance testing and measurements of air kerma at the isocenter for each kVp station for a range of clinically used mAs settings will performed initially when the CBCT unit is installed, and following any move of the

CBCT to another area inside or outside the initial clinical site. This testing is to ensure that the equipment performance is in agreement with the manufacturer’s technical specifications.

2. Performance Testing. Each CBCT unit shall undergo periodic quality control tests to insure 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.

3. Some manufacturers provide a phantom and procedures to perform machine specific quality assurance (QA) tests. In cases where the manufacturer provides a phantom and procedures to perform specific tests but the tests are not included in this SOW, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this SOW.

Acceptance and Annual physics testing for Dental CBCT

1. 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.

2. 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.

3. kVp Accuracy

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

4. kVp Repeatability

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

5. kVp Reproducibility

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

6. 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.

7. 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.

8. 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.

9. Accuracy of Linear Measurements

Using images of an appropriate phantom, assess the accuracy of distance measurements.

10. Accuracy of Patient Dose Metric Indication

Assess the accuracy of the indicated dose metric (typically DAP).

11. 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)

12. Review of the technical QA program

The qualified expert shall review the technical QA program. The review shall include a trend analysis of the QA data. 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.

13. Display Monitors

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.

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

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

b. Review the black-white transition.

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

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

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

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

14. Viewing Conditions

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

E. 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) View box luminance and room illuminance

(13) Review Work Station (RWS) tests

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 quarterly. 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 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. 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. On an ongoing basis (at least semiannually), the following tests should be done for each ultrasound unit. 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.

SECTION C - CONTRACT CLAUSES

C.1 52.219-14 LIMITATIONS ON SUBCONTRACTING (JAN 2017)

(a) This clause does not apply to the unrestricted portion of a partial set-aside.

(b) Applicability. This clause applies only to—

(1) Contracts that have been set aside or reserved for small business concerns or 8(a) participants;

(2) Part or parts of a multiple-award contract that have been set aside for small business concerns or

8(a) participants; and

(3) Orders set aside for small business or 8(a) participants under multiple-award contracts as described in 8.405-5 and 16.505(b)(2)(i)(F).

(c) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that in performance of the contract in the case of a contract for—

(1) Services (except construction). At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.

(2) Supplies (other than procurement from a nonmanufacturer of such supplies). The concern shall perform work for at least 50 percent of the cost of manufacturing the supplies, not including the cost of materials.

(3) General construction. The concern will perform at least 15 percent of the cost of the contract, not including the cost of materials, with its own employees.

(4) Construction by special trade contractors. The concern will perform at least 25 percent of the cost of the contract, not including the cost of materials, with its own employees.

(End of Clause)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS (JAN 2017)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any

Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the

Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR

52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the

Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds

Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other

Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by

EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act

(31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the

Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the

Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the

Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in

32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31

U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts;

18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety

Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) System for Award Management (SAM).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data.

To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2)(i) If a Contractor has legally changed its business name, "doing business as" name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in

FAR subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day's written notification of its intention to (A) change the name in the SAM database; (B) comply with the requirements of subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor must provide with the notification sufficient documentation to support the legally changed name.

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the SAM information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the "Suspension of Payment" paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the SAM record to reflect an assignee for the purpose of assignment of claims (see Subpart

32.8, Assignment of Claims). Assignees shall be separately registered in the SAM database. Information provided to the Contractor's SAM record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the "Suspension of payment" paragraph of the EFT clause of this contract.

(4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via SAM accessed through https://www.acquisition.gov.

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-

Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the

EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the

Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS

(AUG 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing

Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

https://www.acquisition.gov/

(2) 52.204–23, Prohibition on Contracting for Hardware, Software,…