Statement of Work (DRAFT).pdf

Statement of Work Medical Physicist Inspec�ons

Central Arkansas Veterans Healthcare System

A. GENERAL INFORMATION

This acquisition is for the annual Inspection of all relevant Radiographic Equipment at CAVHS Little Rock campus at 4300 W. 7th St, Little Rock AR, 72205, North Little Rock campus at 2200 Fort Roots Drive, North Little Rock, AR 72114 and VA operated Community Based Outpatient Clinics (CBOC) located at 1520 East Dave Ward Dr., Conway, AR 72032; 3106 West 2nd Ct. Russellville, AR 72801; 1120 South Main Street, Searcy, AR 72143; and 177 Sawtooth Oaks St. Hot Springs, AR 71901.

1. Scope of Work:

The Contractor shall furnish all necessary travel, labor, material, supplies, tools, equipment, documentation, and qualified personnel to provide on-site diagnostic medical physics support or services as followed:

• Provide annual inspections of all radiographic and Nuclear Medicine equipment as required to meet the directives and Code of Federal Regulations (CFR). CFR-Code of Federal Regulations Title 21; Mammography Quality Standards Act (MQSA) (Public Law 102-539) and CFR Title 10.

• Validate that the specifications of new equipment are met.

• Supervision of acceptance testing and performance verification.

• Supervision of calibration, preventive maintenance, and documentation of all relevant information.

• Determination of shielding required for new or renovated equipment rooms for ionizing radiation and for radiofrequency and magnetic fields.

• Provide inspections on equipment prior to it being put back into service after it has been taken down for repairs that effect the imaging quality or radiation output. This data must be reported to the Radiation Safety Officer (RSO) within the next business day so that equipment can be utilized for patient care.

2. Background: It is an FDA requirement that all radiographic equipment be monitored to assure the safety of the patient and the medical staff. (CFR-Code of Federal Regulations Title 21). The first responsibility of the medical physicist is to the patient-to ensure that the programs are in place to facilitate the production of quality diagnostic images consistent with the available technology and which optimize safety (including radiation, mechanical and electrical) for the patient. In addition to assure that the Mammography program remains accredited the requirements of Mammography Quality Standards Act (MQSA) (Public Law 102-539) must be met.

3. Contract Type: Firm Fixed Price, with Optional Tasks

4. Period of Performance: Base Year plus Four Option Year periods. Anticipated contract start date is on or around July 25, 2024.

B. GENERAL REQUIREMENTS

Table 1 contains a list of equipment to be inspected along with the last inspection date. The contractor shall compete the required inspections for each piece of equipment within 365-days of the last inspection listed, to ensure CAVHS compliance with applicable standards. The Contractor shall maintain a schedule showing when each piece of equipment is due for subsequent inspections and shall proactively schedule inspections with the CAVHS Radiation Safety Officer or the COR.

Table 1- Equipment to be Inspected

Type1 Type2 Manufacturer Model Location Room Notes Insp. Due

NucMed GAMMA CAMERA Philips Philips Skylight 1D-159 NUC MED

NOT

OPERATIONAL 5/30/2020

R&F XRAY R&F UNIT

PHILIPS

MEDICAL

EASY

DIAGNOST

ELEVA 233-66-N NLR Room #3

NOT

OPERATIONAL

3/5/2021

Fluoro-mini

MINI C ARM (Mini

88716) HOLOGIC INC.

Orthoscan TAU 1515 1000-

2E-161-

01-L Mini-C

NOT

OPERATIONAL

3/18/2023 Fluoro-mobile MOBILE C-ARM GE OEC Elite 2B (OR) OR C-arm

POC:

3/8/2024

Fluoro-mobile MOBILE C-ARM #1 OEC

9900 Elite PM Care 2B OR C-Arm #1

POC:

3/13/2024

R&F XRAY R&F UNIT

PHILIPS

MEDICAL

CombiDiagnost

R90 1E-204-

01-L LR R/F Room 9 2 tubes (new install 3/22) 3/29/2024

Fluoro-fixed Bi-Plane (2 tubes)

GENERAL

ELECTRIC

INNOVA (Bi-plane)

1E-177F- 01-L IR Biplane Room

3/29/2024 Rad-fixed XRAY UNIT Philips

Digital Diagnost

1E-191- 01-L LR X-Ray Room 1

3/29/2024

Rad-fixed XRAY UNIT

GENERAL

ELECTRIC

DISCOVERY

656G2

1E-192- 01-L LR X-Ray Room 2 mobile MOBILE XRAY

PHILIPS

MEDICAL

MOBILE

DIAGNOST

w/DR Mobile 1 Portable mobile MOBILE XRAY

PHILIPS

MEDICAL

MOBILE

DIAGNOST

w/DR Mobile 2 Portable

Received 11/2020

3/29/2024 Fluoro-mobile

MOBILE C-ARM

(1E182/184) GE 9900 Elite

1E- 182/184 IR Specials Area

New system in 2019 3/29/2024

Fluoro-fixed Single Plane

GENERAL

ELECTRIC

DISCOVERY IGS

1E-177E- 01-L

IR Single Plane Room mobile MOBILE XRAY

PHILIPS

MEDICAL

MOBILE

DIAGNOST

w/DR Mobile 3 LR Portable

Received 9/2021

3/29/2024

Rad-mobile MOBILE XRAY

PHILIPS

MEDICAL

MOBILE

DIAGNOST

w/DR Mobile 4 LR Portable

Received 9/2021

3/29/2024 Fluoro-fixed UROLOGY X-RAY

SIEMENS

MEDICAL Uroskop

2B-134- 01-L OR 11 (Cysto)

Fluoro-fixed

ENDOVASCULAR

LAB

PHILIPS

MEDICAL ALLURA FD20

2B-120-

01-L OR 5 (Endo Lab) fixed UROLOGY X-RAY

SIEMENS

MEDICAL Uroskop

2B-173- 01-L OR 12 (Cysto) mobile MOBILE C-ARM #3 GE OEC Elite 2B (OR) OR C-arm #3

POC:

3/29/2024

Fluoro-mobile MOBILE C-ARM #2

GENERAL

ELECTRIC

OEC 9900

ELITE 2B (OR) OR C-Arm #2

POC:

mobile MOBILE C-ARM #4 GE OEC Elite 2B (OR) OR C-arm #4

POC:

3/29/2024

Fluoro-mobile O-ARM MEDTRONIC

BI-700-00020

(O-arm)

2B (OR

12) OR O-arm

POC:

3/29/2024

Fluoro-fixed

FIXED FLUORO

CATH LAB

PHILIPS

MEDICAL Allura Clarity

5C-140- 01-L Cath Lab #2

POC:

3/29/2024

Fluoro-fixed

FIXED FLUORO

CATH LAB

GENERAL

ELECTRIC

INNOVA 3100

IQ

5C-104- 01-L Cath Lab #1

POC:

3/29/2024

Fluoro-fixed

FIXED FLUORO EP

LAB

PHILIPS

MEDICAL Allura Clarity

5C-130- 01-L EP Lab

POC:

3/29/2024

Fluoro-mobile MOBILE C ARM

GENERAL

ELECTRIC OEC ELITE

5B-129- 01-L GI Fluoroscopy

POC:

3/29/2024

Rad-fixed XRAY UNIT

PHILIPS

MEDICAL

DIGITAL

DIAGNOST 230-66-N NLR Room #2

POC:

3/29/2024

Rad-fixed XRAY UNIT

GENERAL

ELECTRIC DISCOVERY NLR Room #4

POC:

3/29/2024

Rad-fixed XRAY UNIT

PHILIPS

MEDICAL

DIGITAL

DIAGNOST 237-66-N NLR Room #1

POC:

3/29/2024

Rad-fixed XRAY UNIT Philips

Digital Diagnost

1E-203- 01-L LR Xray Room 10 mini

MINI C ARM (Mini

88715) HOLOGIC INC.

Orthoscan TAU 1515 1000-

2E-161-

01-L Mini-C

New mini Carm 10/2021

3/29/2024 Rad-fixed XRAY UNIT

GENERAL

ELECTRIC

DISCOVERY

XR656

1E-195- 01-L LR X-Ray Room 3

R&F XRAY R&F UNIT

PHILIPS

MEDICAL

CombiDiagnost

R90 1E-207-

01-L LR R/F Room 7 2 tubes (new install 6/22) 3/29/2024

Rad-mobile MOBILE XRAY

GE AMX

Navigate 6555000-64

Mobile tested early NLR Portable

New Portable

#2 NLR

3/29/2024

Rad-mobile MOBILE XRAY

GENERAL

ELECTRIC

OPTIMA

XR220AMX Mobile LR Portable (GE)

NucMed GAMMA CAMERA Spectrum Dynamics

D-SPECT

Cardio 1D-178 NUC MED

Installed 01/25-

27/2023 3/29/2024

NucMed GAMMA CAMERA Philips Philips

Brightview X 1D-178 NUC MED

POC:

5/17/2024

NucMed GAMMA CAMERA Philips Philips

Brightview 1D-178 NUC MED

POC:

5/17/2024 NucMed

(CT) SPECT-CT

GENERAL

ELECTRIC

Discovery 670

DR 1D-177 NUC MED

POC:

5/17/2024

CBCT CBCT/Panographic CARESTREAM 9300 #DLA019 2B-110- 170-N 2B-110

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC INTRA

2B-124B- 170-N 2B-124B

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-153- 170-N 2B-153

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-147- 170-N 2B-147

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-145- 170-N 2B-145

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-138- 170-N 2B-138

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-135- 170-N 2B-135

POC:

6/7/2024

Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-131- 170-N 2B-131

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-125- 170-N 2B-125

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC INTRA

2B-124A- 170-N 2B-124A

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-139- 170-N 2B-139

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-130B- 170-N 2B-130B

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-132B- 170-N 2B-132B

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-148B- 170-N 2B-148B

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-150B- 170-N 2B-150B

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC Intra IXW85-K

2B-141A- 170-N 2B-141A

POC:

6/7/2024

Rad- Dental DENTAL X-RAY PLANMECA INC ProMax 2D S3

2B-110- 170-N 2B-110

POC:

6/7/2024

MRI MRI Siemens Magnetom

Skyra 3T MRI Area MRI

6/7/2024

MRI MRI GE

Optima

MR540w 1.5T MRI Area MRI SNR issues

6/14/2024

CT CT SCANNER Canon Aquilion ONE

Prism 1E-197-

01-L CT Room #1

Canon Aquilion ONE Prism (Issue with CNR) 6/21/2024

Rad-fixed XRAY UNIT

PHILIPS

MEDICAL

DIGITAL

DIAGNOST S42-CBC

1120 South Main St Searcy, AR

Ph: 501-207-4700 ex. 34715 7/6/2024

Rad-fixed XRAY UNIT

PHILIPS

MEDICAL

DIGITAL

DIAGNOST

HS125-

CBC

177 Sawtooth Oak St Hot Springs, AR

Ph: 501-520-6250 ex. 36285 8/8/2024

Rad-fixed XRAY UNIT

GENERAL

ELECTRIC

DISCOVERY

XR650 R125-CBC

3106 W 2nd Court Russellville, AR

Ph: 479-880-5100 ex 35180 8/8/2024

Rad-fixed XRAY UNIT

GENERAL

ELECTRIC

DISCOVERY

XR650 C134-CBC

1520 East Dave Ward Dr.

Conway, AR

CBOC Ph: 501-548-0500 Ext. 30581 8/8/2024

CT CT SCANNER

GENERAL

ELECTRIC

OPTIMA CT660

VCT 32

1E-169- 01-L CT Room #3

32 slice

9/21/2024

Mammo

MAMMO

(BIOPSY) HOLOGIC INC. AFFIRM 1E-135 MAMMOGRAPH

9/21/2024 Bone

Density

BONE

DENSITOMETER HOLOGIC INC. Horizon 1E-205-

01-L DENSITOMETER

Inspected by

RSO 10/5/2024

Rad-

Dental DENTAL XRAY Dexis Focus 2B-142- 170-N 2B-142

10/12/2024

Dental DENTAL XRAY Dexis Focus 2B-156- 170-N 2B-156

10/12/2024

CT CT SCANNER

GENERAL

ELECTRIC

OPTIMA VCT

1E-198- 01-L CT Room #2

1/3/2025

CT CT SCANNER TBD TBD

Mobile truck Pending delivery

TBD

mobile MOBILE XRAY

GE AMX

Navigate 6555000-64 Mobile NLR Portable

New Portable #1 NLR down

1/3/2025

Mammo 2D MAMMO Larad/Hologic Dimensions

DBT 1E-135A Mammo Room 2

2/7/2025

Mammo

3D/TOMO

MAMMO Lorad/Hologic

Dimensions DBT 1E-135C Mammo Room 1

2/7/2025

C. SPECIFIC MANDATORY TASKS

1. The contractor shall provide annual inspections of specific equipment. Equipment inspection dates vary throughout the year and are on an established schedule.

2. The contractor shall not allow a period of 366 days to elapse between inspections without written specific equipment and specific incident approval by the RSO or COR.

3. The contractor shall provide a written listing of all annual equipment inspections, and the subsequent findings within 30 days of completion of the inspection.

4. A detailed report of findings will be provided to the facility Radiation Safety Officer (RSO) within 30 days of completed inspection.

D. SCHEDULE OF DELIVERABLES

1. The contractor shall complete the inspections per established schedules throughout the year to assure that regulations and requirements are met. The contractor may revise the schedule for each type, piece, or location of equipment for convenience and/or operational effectiveness, however any changes are subject to CAVHS RSO or COR approval.

2. The contractor shall deliver final reports to the RSO and COR within 30 days of inspection. If any delays occur in providing these reports, the contractor shall provide the reason for the delay in writing to the Contracting Officer, (CO) including a firm commitment of when the work shall be completed. This notice to the CO shall site reason for delay, and the impact on the overall project.

The CO will then review the facts and issue a response in accordance with applicable regulations.

3. Final reports on inspection of equipment that was down for repair shall be delivered within 24 hours of inspection to prevent delays in patient care.

4. The contractor shall perform emergency inspections on-site within 4 hours of receiving notification from the RSO or COR.

E. OPTIONAL TASKS

Optional Tasks (see Price/Cost Schedule below) are not guaranteed and will only be executed upon notification from the RSO/COR.

1. CAVHS does not currently have a PET CT but expects to have one implemented during the contract period of performance. If this CLIN is exercised, the contractor shall perform & report initial and future inspections in accordance with the inspection requirements of this SOW.

2. The Service Rider is provided as a contract option to be exercised at the discretion of the Government, to allow for reinspections and/or related medical physicists services, such as shielding analysis for new or moved equipment.

Price/Cost Schedule

Equipment/Service Quantity Cost Extended Cost

Required services

General Radiographic X-Ray Survey (including mobile & portable) 37

Radiographic/Fluoroscopic X-ray Survey 3

Dental X-Ray Survey 18

CT Survey 4

Cone Beam CT Survey 1

MRI Survey 2

Mammography Survey 2

Stereotactic Mammography Survey 1

Annual Gamma Camera Survey 3

Annual SPECT/CT Survey 1

Sub-Total: 72

Optional Services

Annual PET/CT Survey 1

Service Rider for ancillary services & reinspections 1 $6,000

Grand Total:

F. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Cost incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

G. REPORTING REQUIREMENTS

Written Reports are required within 30 days of completion of inspections and cover all equipment that is due during that scheduled time. Reports shall be provided to the facility RSO. Reports on equipment returned to service after repair that involve radiation output will be provided within 24 hours of inspection.

H. GOVERNMENT RESPONSIBILITIES

The Government shall ensure that all equipment is readily available for inspection.

I. CONTRACTOR EXPERIENCE REQUIREMENTS

Contractor shall be certified in the appropriate area by one of the following boards: The American Board of Radiology (ABR), The American Board of Medical Physics (ABMP), The American Board of

Science in Nuclear Medicine (ABSNM), The Canadian College of Physicists in Medicine (CCPM) or The American Board of Health Physics (ABHP).

J. CONFIDENTIALITY AND NONDISCLOSURE

1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the RSO who will provide a copy to the CO at the conclusion of the task order.

2. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the Contracting Officer.

K. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Background Investigation – The level of background investigation commensurate with the required level of access is minimum background investigation.

L. RECORDS REQUIREMENTS

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Central Arkansas Veterans Healthcare system and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Central Arkansas Veterans Healthcare system or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C.

2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Central Arkansas Veterans Healthcare system. The agency must report promptly to NARA in accordance with 36 CFR 1230.