36C25620Q0018-0003003.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 29

0003 01-17-2020

580-20-1-5129-0001

None

Y

Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298

Y

Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298

To all Offerors/Bidders

36C25620Q0018

11-05-2019

X

X x

** HOUR & DATE for Receipt of Offers is EXTENDED to: January 21, 2020/ 10:00a.m. Central Time

See CONTINUATION Page x 1

The purpose of this Amendment is to extend the date for receipt of offers to January 21, 2020 @ 10:00a.m. (Central time) and change the period of performance in section B.2. Price/Cost Schedule and revise section B.3 Performance Work Statement, #4, Performance Period.

The contractor SHALL return a signed copy of this amendment with their Technical Quote to be considered for award.

Failure to return a signed copy of this Amendment may result in the contractor being deemed non-compliant.

See attached: 36C25620Q0018/A0003

Jeneice McClinton Contracting Officer

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

50.00 EA __________________ __________________

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, for annual performance evaluation and quality assurance survey on radiographic x-ray machines.

Contract Period: Base POP Begin: 01-30-2020 POP End: 09-30-2020

14.00 EA __________________ __________________

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, and perform evaluations on newly installed/repaired X-Ray machines.

Contract Period: Base

11.00 EA __________________ __________________

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations to perform evaluation and quality assurance surveys of radiographic x-ray units located at VA Outpatient Clinics located as follows: Beaumont, Lufkin, Richmond, Texas City, Tomball, Katy, Conroe and Lake Jackson.

Contract Period: Base

27.00 EA __________________ __________________

perform annual inspections, tests and calibrations, evaluation and quality assurance survey for combination radiographic/fluoroscopic X-Ray units.

Contract Period: Base

10.00 EA __________________ __________________

perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey on Computed Tomography (CT) machines.

Contract Period: Base

1.00 EA __________________ __________________

Contractor shall provide preventative maintenance check on CT simulator machine.

Contract Period: Base

5.00 EA __________________ __________________

perform annual inspections, tests and calibrations, quality assurance check and physics inspection on Magnetic Resonance Imager machine

(MRI).

Contract Period: Base

7.00 EA __________________ __________________

perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey and radiation survey for Nuclear Medicine Cameras including 4 SPECT/CT units and one

PET/CT.

Contract Period: Base

1.00 JB __________________ __________________

Contractor shall review MEDVAMC quality assurance program for Radiology X-Ray and submit recommendations.

Contract Period: Base

4.00 EA __________________ __________________

Contractor shall provide Radiation Safety survey of DEXA units in Nuclear Medicine and Research.

Contract Period: Base

20.00 EA __________________ __________________

Contractor shall provide radiation shielding design analysis for rooms that X-ray machines and nuclear medicine cameras will occupy.

Contract Period: Base

Contractor shall provide post construction shielding integrity analysis in rooms in which x-ray machines and nuclear medicine cameras reside.

Contract Period: Base

Contractor shall provide computed radiography reader quality assurance testing.

Contract Period: Base

2.00 EA __________________ __________________

Contractor shall provide annual physics evaluation of mammography X- Ray units.

Contract Period: Base

Contractor shall provide annual physics performance evaluation of mammography ultrasound unit.

Contract Period: Base

BASE YEAR TOTAL AMOUNT: ___________________

OPTION PERIOD 1:

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, for annual performance evaluation and quality assurance survey on radiographic x-ray machines.

Contract Period: Option 1 POP Begin: 10-01-2020 POP End: 09-30-2021

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, and perform evaluations on newly installed/repaired X-Ray machines.

Contract Period: Option 1

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations to perform evaluation and quality assurance surveys of radiographic x-ray units located at VA Outpatient Clinics located as follows: Beaumont, Lufkin, Richmond, Texas City, Tomball, Katy, Conroe and Lake Jackson.

Contract Period: Option 1

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, evaluation and quality assurance survey for combination radiographic/fluoroscopic X-Ray units.

Contract Period: Option 1

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey on Computed Tomography (CT) machines.

Contract Period: Option 1

Contractor shall provide preventative maintenance check on CT simulator machine.

Contract Period: Option 1

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, quality assurance check and physics inspection on Magnetic Resonance Imager machine

(MRI).

Contract Period: Option 1

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey and radiation survey for Nuclear Medicine Cameras including 4 SPECT/CT units and one

PET/CT.

Contract Period: Option 1

Contractor shall review MEDVAMC quality assurance program for Radiology X-Ray and submit recommendations.

Contract Period: Option 1

Contractor shall provide Radiation Safety survey of DEXA units in Nuclear Medicine and Research.

Contract Period: Option 1

Contractor shall provide radiation shielding design analysis for rooms that X-ray machines and nuclear medicine cameras will occupy.

Contract Period: Option 1

Contractor shall provide post construction shielding integrity analysis in rooms in which x-ray machines and nuclear medicine cameras reside.

Contract Period: Option 1

Contractor shall provide computed radiography reader quality assurance testing.

Contract Period: Option 1

Contractor shall provide annual physics evaluation of mammography X- Ray units.

Contract Period: Option 1

Contractor shall provide annual physics performance evaluation of mammography ultrasound unit.

Contract Period: Option 1

OPTION YEAR 1 TOTAL AMOUNT: ___________________

OPTION PERIOD 2:

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, for annual performance evaluation and quality assurance survey on radiographic x-ray machines.

Contract Period: Option 2 POP Begin: 10-01-2021 POP End: 09-30-2022

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, and perform evaluations on newly installed/repaired X-Ray machines.

Contract Period: Option 2

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations to perform evaluation and quality assurance surveys of radiographic x-ray units located at VA Outpatient Clinics located as follows: Beaumont, Lufkin, Richmond, Texas City, Tomball, Katy, Conroe and Lake Jackson.

Contract Period: Option 2

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, evaluation and quality assurance survey for combination radiographic/fluoroscopic X-Ray units.

Contract Period: Option 2

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey on Computed Tomography (CT) machines.

Contract Period: Option 2

Contractor shall provide preventative maintenance check on CT simulator machine.

Contract Period: Option 2

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, quality assurance check and physics inspection on Magnetic Resonance Imager machine

(MRI).

Contract Period: Option 2

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey and radiation survey for Nuclear Medicine Cameras including 4 SPECT/CT units and one

PET/CT.

Contract Period: Option 2

Contractor shall review MEDVAMC quality assurance program for Radiology X-Ray and submit recommendations.

Contract Period: Option 2

Contractor shall provide Radiation Safety survey of DEXA units in Nuclear Medicine and Research.

Contract Period: Option 2

Contractor shall provide radiation shielding design analysis for rooms that X-ray machines and nuclear medicine cameras will occupy.

Contract Period: Option 2

Contractor shall provide post construction shielding integrity analysis in rooms in which x-ray machines and nuclear medicine cameras reside.

Contract Period: Option 2

Contractor shall provide computed radiography reader quality assurance testing.

Contract Period: Option 2

Contractor shall provide annual physics evaluation of mammography X- Ray units.

Contract Period: Option 2

Contractor shall provide annual physics performance evaluation of mammography ultrasound unit.

Contract Period: Option 2

OPTION YEAR 2 TOTAL AMOUNT: _____________________

OPTION PERIOD 3:

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, for annual performance evaluation and quality assurance survey on radiographic x-ray machines.

Contract Period: Option 3 POP Begin: 10-01-2022 POP End: 09-30-2023

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, and perform evaluations on newly installed/repaired X-Ray machines.

Contract Period: Option 3

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations to perform evaluation and quality assurance surveys of radiographic x-ray units located at VA Outpatient Clinics located as follows: Beaumont, Lufkin, Richmond, Texas City, Tomball, Katy, Conroe and Lake Jackson.

Contract Period: Option 3

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, evaluation and quality assurance survey for combination radiographic/fluoroscopic X-Ray units.

Contract Period: Option 3

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey on Computed Tomography (CT) machines.

Contract Period: Option 3

Contractor shall provide preventative maintenance check on CT simulator machine.

Contract Period: Option 3

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, quality assurance check and physics inspection on Magnetic Resonance Imager machine

(MRI).

Contract Period: Option 3

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey and radiation survey for Nuclear Medicine Cameras including 4 SPECT/CT units and one

PET/CT.

Contract Period: Option 3

Contractor shall review MEDVAMC quality assurance program for Radiology X-Ray and submit recommendations.

Contract Period: Option 3

Contractor shall provide Radiation Safety survey of DEXA units in Nuclear Medicine and Research.

Contract Period: Option 3

Contractor shall provide radiation shielding design analysis for rooms that X-ray machines and nuclear medicine cameras will occupy.

Contract Period: Option 3

Contractor shall provide post construction shielding integrity analysis in rooms in which x-ray machines and nuclear medicine cameras reside.

Contract Period: Option 3

Contractor shall provide computed radiography reader quality assurance testing.

Contract Period: Option 3

Contractor shall provide annual physics evaluation of mammography X- Ray units.

Contract Period: Option 3

Contractor shall provide annual physics performance evaluation of mammography ultrasound unit.

Contract Period: Option 3

OPTION YEAR 3 TOTAL AMOUNT: __________________

OPTION PERIOD 4:

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, for annual performance evaluation and quality assurance survey on radiographic x-ray machines.

Contract Period: Option 4 POP Begin: 10-01-2023 POP End: 09-30-2024

Contractor shall furnish all labor, tools, phantoms, and equipment to perform annual inspections, tests and calibrations, and perform evaluations on newly installed/repaired X-Ray machines.

Contract Period: Option 4 perform annual inspections, tests and calibrations to perform evaluation and quality assurance surveys of radiographic x-ray units located at VA Outpatient Clinics located as follows: Beaumont, Lufkin, Richmond, Texas City, Tomball, Katy, Conroe and Lake Jackson.

Contract Period: Option 4

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, evaluation and quality assurance survey for combination radiographic/fluoroscopic X-Ray units.

Contract Period: Option 4

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey on Computed Tomography (CT) machines.

Contract Period: Option 4

Contractor shall provide preventative maintenance check on CT simulator machine.

Contract Period: Option 4

Contractor shall furnish all labor tools, phantoms, and equipment to perform annual inspections, tests and calibrations, quality assurance check and physics inspection on Magnetic Resonance Imager machine

(MRI).

Contract Period: Option 4 perform annual inspections, tests and calibrations, performance evaluations and quality assurance survey and radiation survey for Nuclear Medicine Cameras including 4 SPECT/CT units and one

PET/CT.

Contract Period: Option 4

Contractor shall review MEDVAMC quality assurance program for Radiology X-Ray and submit recommendations.

Contract Period: Option 4

Contractor shall provide Radiation Safety survey of DEXA units in Nuclear Medicine and Research.

Contract Period: Option 4

Contractor shall provide radiation shielding design analysis for rooms that X-ray machines and nuclear medicine cameras will occupy.

Contract Period: Option 4

Contractor shall provide post construction shielding integrity analysis in rooms in which x-ray machines and nuclear medicine cameras reside.

Contract Period: Option 4

Contractor shall provide computed radiography reader quality assurance testing.

Contract Period: Option 4

Contractor shall provide annual physics evaluation of mammography X- Ray units.

Contract Period: Option 4

Contractor shall provide annual physics performance evaluation of mammography ultrasound unit.

Contract Period: Option 4

OPTION YEAR 4 TOTAL AMOUNT: _________________

GRAND TOTAL

“Evaluations of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by using the prices offered for the last option period to determine the price for a 6-month option period, which will be added to the base and other option years to arrive at the total price. Evaluation of options will not obligate the Government to exercise the option(s).”

B.3 PERFORMANCE WORK STATEMENT

1. General Information

1.1 Contractor to furnish annual inspection of all radiographic equipment and physics surveys of diagnostic imaging equipment identified in section 19 of this performance work statement (PWS) as required by Veteran Affairs (VA) National Health Physics Program, Texas Regulations for Control of Radiation, and U.S. Food and Drug Administration (FDA) at the Michael E. DeBakey VA Medical Center in Houston, Texas and VA outpatient clinics.

2. The following laws, regulations, policies, and procedures, including all subsequent changes or updates apply:

FAR Federal Acquisition Regulation

VAAR Veterans Administration Acquisition Regulation

Standards All applicable Federal, State, Local and Industry: Laws, Policies and Standards as applicable to the proper performance of afore and hereafter described.

Glossary. Acronyms used in this Performance Work Statement (PWS) are listed below:

COR Contracting Officer’s Representative

PWS Performance Work Statement

MEDVAMC Michael E. DeBakey VA Medical Center

FDA U.S. Food and Drug Administration (FDA)

MQSA Mammography Quality Standards Act

RSO Radiation Safety Officer

QMP Qualified Medical Physicist

3. Type of Contract: Firm-Fixed-Price

4. Performance Period: Date of award through September 30, 2020 with four (4) one (1) year options to be exercised at the discretion of the Government.

4.1 Option Period 1: October 1, 2020 – September 30, 2021

4.2 Option Period 2: October 1, 2021 – September 30, 2022

4.3 Option Period 3: October 1, 2022 – September 30, 2023

4.4 Option Period 4: October 1, 2023 – September 30, 2024

4.5 Place of Performance: The Michael E DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd., Bldg 100., Houston, Texas 77030, VA Outpatient Clinics in Beaumont, Lufkin, Richmond, Texas City, Tomball, Katy, Conroe and Lake Jackson. As well as any other current or future Community Based Outpatient Clinics (CBOC).

4.6 The current locations of the clinics are as follows:

Katy VA Outpatient Clinic

750 Westgreen Blvd, Katy, TX 77450

Richmond VA Outpatient Clinic

22001 Southwest Freeway, Suite 200, Richmond, TX 77469

Conroe VA Outpatient Clinic

800 Riverwood Ct Ste 100, Conroe, TX 77304

Lake Jackson VA Outpatient Clinic

208 Oak Drive South, Lake Jackson, TX 77566

Tomball VA Outpatient Clinic

1200 W. Main Street, Tomball, TX 77375

Texas City VA Outpatient Clinic

9300 Emmett F.

Lowry Expressway, Suite 206, Texas City, TX 77591

Galveston VA Outpatient Clinic

3828 Avenue N, Galveston, TX 77550

Beaumont VA Outpatient Clinic

3420 Veterans Circle, Beaumont, TX 77707

VA Charles Wilson Clinic Outpatient Clinic

2206 N John Redditt Dr., Lufkin, TX 75904

5. Work Hours: Monday through Friday 8:00a.m. - 4:30p.m., excluding federal holidays, and unless other times are arranged in advance and approved in writing by the government point of contact.

5.1 Federal Holidays: The ten holidays observed by the Federal Government are:

Federal Holiday Date

New Year’s Day January 01

Martin Luther King’s Birthday

Third Monday in January

President’s Day Third Monday in February

Memorial Day Last Monday in May

Independence Day July 04

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day November 11

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25

5.2 If the holiday falls on a Sunday, the following Monday will be observed as a National holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National holiday by U.S. Government Agencies, and any other day specifically declared by the President of the United States.

6. Contractor Experience Requirements:

Contractors shall have at least five (5) years of experience working as a qualified medical physicist (QMP) and shall have all the state licenses or approved, and have certification required by local, state, and Federal regulations. A QMP is a person who is certified by the American Board of Radiology, American Board of Medical Physics, American Board of Health Physics, the Canadian College of Physicists in Medicine, or state licensure.

• 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).

The Contractor shall submit a copy of proof with their technical quote of state license or approved, and certification required by local, state, and Federal regulations to perform work under this contract. Failure to submit a copy of proof with the technical quote of state license or approved, and certification required by local, state, and Federal regulations shall result in a non-responsive technical quote.

7. General Requirements:

7.1 The Contractor shall furnish all labor, tools, phantoms, equipment, documentation, and qualified personnel to perform on-site diagnostic medical physics support and/or services, annual inspections, tests, and calibrations according to the specifications as required by VA National Health Physics Program, Texas Regulations for Control of Radiation, and FDA. All inspection services must be in conformance to the manufacturer guidelines and/or the following industry standards, as applicable, whichever is more stringent:

a. Code of Federal Regulations (CFR). CFR-Code of Federal Regulations Title 21;

b. Mammography Quality Standards Act (MQSA) (Public Law 102-539)

7.2 A designated government point of contact shall be assigned to this procurement.

Written notification shall be provided to the Contractor after award.

7.3 Travel: The contractor is responsible for providing transportation/travel for all materials, supplies, personnel and all items needed for the duration of this contract unless stated otherwise elsewhere.

7.4 Before making any inspections, the Contractor shall submit a schedule and sample documentation sheets for the designated Contracting Officer Representative (COR) or MEDVAMC government point of contact approval. The Contractor shall arrange scheduling through the designated government point of contact or COR. The contractor shall provide annual inspections of specific equipment. NOTE: Equipment inspection dates vary throughout the year and are on an established schedule.

7.5 The Contractor shall document and complete all work according to the state of

Texas, American Association of Physicists in Medicine, FDA, and American College of Radiology requirements/guidelines.

7.6 The Contractor shall schedule and test all x-ray, computed tomography (CT), and nuclear medicine units with the government point of contact or COR during fiscal year 2020. Awarded option years shall be scheduled with the designated COR or MEDVAMC government point of contact and shall not exceed 14 months past the previous survey.

7.7 The Contractor (QMP) shall annually inspect x-ray, CT, MRI, mammography, ultrasound, and nuclear medicine equipment.

7.8 The Contractor (QMP) shall inspect x-ray, CT, MRI, ultrasound, and nuclear medicine equipment prior to first clinical use for new or relocated systems within a 21-day time frame, post notification by the designated COR or MEDVAMC government point of contact.

7.9 The Contractor (QMP) shall inspect mammography equipment prior to first clinical use for new or relocated systems within a 48-hour time frame post notification by the designated COR or MEDVAMC government point of contact.

7.10 The Contractor (QMP) shall inspect x-ray equipment after major repairs or replacement of a major certified component (e.g., tube change, detector replacement, or generator repair) no later than 30 days post notification by the designated COR or MEDVAMC government point of contact.

7.11 The Contractor (QMP) shall annually inspect CR readers.

7.12 The Contractor (QMP) shall perform pre-construction shielding analysis of x-ray rooms at the request of the designated government point of contact or COR.

7.13 The Contractor (QMP) shall perform post-construction shielding surveys on x-ray rooms at the request of the designated government point of contact or COR.

7.14 The Contractor (QMP) shall annually review technical quality assurance (QA) program for x-ray imaging.

8. Reporting Requirements:

8.1 The Contractor shall provide a detailed report of findings within 30 days of completed inspection to the designated COR or MEDVAMC government point of contact facility Radiation Safety Officer (RSO).

8.2 The Contractor shall provide written reports on equipment returned to service after repair that involve radiation output within 24 hours of inspection to the designated COR or

8.3 The Contractor shall electronically submit reports of each inspection/test/calibration no later than three (3) weeks after the completion of the testing to the designated COR or

8.4 The Contractor shall provide a report listing each device (including model and serial number) and system tested as well as results of the test and shall include a detailed list of deficiencies and recommendations. The contractor shall list described methods of how the results were obtained in the document report.

8.5 The Contractor shall provide a summary for all devices in a brief, executive summary format listing deficiencies and recommendations.

8.6 The Contractor shall sign and place stickers on each device or system documenting the annual testing, including the maximum and standard exposure rates for fluoroscopy.

8.7 The Contractor (QMP) shall be available to answer any questions or concerns the designated COR or government point of contact may have during the equipment being tested and/or inspected.

8.8 The Contractor shall validate the specifications of new equipment;

8.9 The Contractor shall provide supervision of acceptance testing and performance verification.

8.10 The Contractor shall provide supervision of calibration, preventive maintenance, and documentation of all relevant information.

8.11 The Contractor shall provide determination of shielding required for new or renovated equipment rooms for ionizing radiation and for radiofrequency and magnetic fields.

8.12 The Contractor shall provide inspections on equipment prior to it being put back into service after it has been taken down for repairs that affect the imaging quality or radiation output. The Contractor shall provide the required data and report to the Radiation Safety Officer (RSO) within the next business day to utilize functional equipment for patient care.

8.13 The Contractor shall immediately notify the designated COR or government point of contact for fluoroscopy units, should the maximum exposure rate, measured in accordance with 21CFR1020.32(d)(3) and TAC 289.227(m)(3)(B)(iii)(IV), is greater than 10 R/min in any mode prior to departure from the inspection site.

8.14 The Contractor shall document reports for fluoroscopy units as follows:

a. Confirm cumulative fluoro time and cumulative air kerma are displayed on the in-room monitor.

b. Confirm “last image hold” functions.

c. Verify the x-ray beam is completely blocked by the image receptor.

9. Parts:

9.1 Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical services contract for maintenance of medical equipment (i.e., replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

9.2 The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies.

10. Deliverables:

10.1 The contractor shall complete the annual inspections per established schedules throughout the year to assure that regulations and requirements are met.

10.2 Final reports shall be delivered to the RSO within 30 days of inspection, any delay in reports, the contractor is required to explain the reason for the delay in writing to the designated COR or government point of contact including a firm commitment of when the work shall be completed. This notice will be provided to the CO and become a part of the contract file, 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.

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

11. Quality Assurance Surveillance Plan (QASP) Title: Annual Physics Survey Imaging Equipment (MEDVAMC)

11.1 Introduction

This Quality Assurance Surveillance Plan has been developed to evaluate Contractor performance while implementing and executing Performance Work Statement (PWS) tasks for this requirement. It is designed to provide an effective surveillance method for monitoring and evaluating the Contractor’s performance for the requirements listed in the Performance Work Statement (PWS).

This QASP does not detail how the Contractor will accomplish the work that is required by the PWS. Rather, this QASP has been created with the premise that the Contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis to ensure that the QASP remains a valid, useful, and enforceable document. However, the Government will coordinate changes with the Contractor (if changes are required). Copies of the original QASP and revisions will be provided to the Contractor and Government officials implementing surveillance activities.

11.2 Objective

The foundation of this Quality Assurance Surveillance Plan (QASP) is derived from the Objective of this requirement which is the following: The overall purpose is to provide chemical treatment, service, complete preventative maintenance (hereafter called PM Service), routine repair service, emergency repair service and on-the-job training for Government owned equipment (listed in the table below).

11.3 Government Roles and Responsibilities

The following Government personnel are responsible for overseeing and coordinating surveillance activities.

Contracting Officer Representative (COR) - The COR is responsible for technical administration of the contract and is responsible for ensuring proper Government surveillance of the Contractor’s performance. The COR is responsible for keeping a quality assurance file and after the contract, or when requested by the CO, providing corresponding documentation to the CO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The Contractor shall refer any changes they deem may affect contract price, terms, or conditions to the CO for action.

Contracting Officer (CO) - The CO is responsible for ensuring performance of all necessary actions for effective contracting, ensuring compliance with the contract terms, and safeguarding the interests of the United States in the contractual relationship. The CO is responsible for ensuring that the Contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.

Upon award or before the performance period start date of the contract the individuals who will be involved in the execution of this Quality Assurance Surveillance Plan (QASP) shall be identified.

12. Performance Standards and Quality Measurement:

12.1 The designated government point of contact shall be responsible for monitoring the Contractor’s performance. Performance deficiencies or poor performance identified during the term of the contract shall be documented by the government and reported to the Contractor. Upon notification of deficiencies or poor performance, the Contractor shall be given 5 days’ time to take corrective action. If determined appropriate, the Contracting Officer and/or other VHA Regional Contracting Office-16 staff members shall meet with representatives of the Contractor to review performance and resolve issues. All deficiencies or poor performance shall be documented and must be corrected within the timeframe specified by the government. The Contractor shall notify the contracting officer when corrections(s) have been made. If the appropriate correction is not made within the timeframe specified, the government shall have the right to terminate the contract in its entirety.

12.2 Nothing in this section is intended to modify or waive the government’s rights outlined in 52.212-4.

12.3 Contractor Performance Assessment Reporting System (CPARS)

(a) FAR 42.1502 directs all Federal agencies to collect past performance information on contracts. The Department of the Department of Veterans Affairs (VA) has implemented Contractor Performance Assessment Reporting System (CPARS) to comply with this regulation. One or more past performance evaluations will be conducted in order to record your contract performance as required by FAR 42.15.

(b) The past performance evaluation process is a totally paperless process using CPARS. CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.

(c) We request that you furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm's past performance evaluation(s) for the contract. Each person granted access will have the ability to provide comments in the Contractors portion of the report and state whether or not the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.

(d) When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CPARS, they will receive an automatically-generated email with detailed login instructions. Further details, systems requirements, and training information for CPARS are available at http://www.cpars.csd.disa.mil/. The CPARS User Manual, registration for On Line Training for Contractor Representatives, and a practice application may be found at this site.

(e) The Assessing Official will complete an interim or final past performance evaluation and the report will be accessible at http://www.cpars.csd.disa.mil/. The Contractor Representative has the option to provide comments on the evaluation, indicate if they concur or do not concur with the evaluation, sign, and then return the evaluation to the Assessing Official. The Contractor Representative has a total of 60 days following the Assessing Official’s evaluation signature date to send comments. If the Contractor Representative sends comments within the first 14 days following the Assessing Official’s signature date and the Assessing Official or Reviewing Official closes the evaluation, the evaluation will become available in PPIRS-RC within 1 day. On day 15 following the Assessing Official’s evaluation signature date, the evaluation will become available in PPIRS-RC with or without Contractor Representative comments and whether or not it has been closed by the Assessing Official or Reviewing Official. If no Contractor http://www.cpars.csd.disa.mil/ http://www.cpars.csd.disa.mil/

Representative comments have been sent and the evaluation has not been closed, it will be marked as “Pending” in PPIRS-RC. If the Contractor Representative sends comments at any time prior to 61 days following the Assessing Official’s evaluation signature date, those comments will be reflected in PPIRS-RC within 1 day. On day 61 following the Assessing Official’s evaluation signature date, the Contractor Representative will be “locked out” of the evaluation and may no longer send comments.

(f) The following guidelines apply concerning Contractor Representative use of the past performance evaluation:

(1) Protect the evaluation as "source selection information." After review, transmit the evaluation by completing and submitting the form through CPARS. If for some reason you are unable to view and/or submit the form through CPARS, contact the Contracting Officer for instructions.

(2) Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.

(3) Prohibit the use of or reference to evaluation data for advertising, promotional material, pre award surveys, responsibility determinations, production readiness reviews, or other similar purposes.

12.4 Performance Standards Requirements Summary Matrix

PWS

Para

Performance Objective

Performance Standard

Acceptable Quality Level

(AQL)

Surveillance Method

Compliance

9.0 Perform on-

site annual inspections of all radiographic equipment (see section 20), diagnostic medical physics support and/or services, tests, and calibrations.

All work shall be completed according to the specification s as required by VA National Health Physics Program, Texas Regulations for Control of Radiation, and U.S.

Food and Drug Administrati o n (FDA).

100% performanc e level

Quality audits of contractor records, areas and inspections reports.

Re performance at no additional cost to the Government

Positive: Acceptable performance rating in Contractor Performance Assessment Reporting System

(CPARS).

Negative: May result in adverse CPARS and/or reperformance of work. Below AQL, non-acceptance of services.

A contract discrepancy report (CDR), will be issued for performance below the AQL.

10.0 The

Contractor shall submit inspection

Accurate reports are delivered to designated

Documents and reports are accurate

Quality audits of contractor records, Positive: Acceptable performance rating in Contractor Performance Assessment Reporting System and test reports as per the

PWS.

government point of contact, RSO and/or COR.

95% of the time.

areas and inspections reports.

(CPARS).

Negative: May result in adverse CPARS and/or reperformance of work. Below AQL, non-acceptance of services.

A contract discrepancy report (CDR), will be issued for performance below the AQL.

13. Government Responsibilities:

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

14. Confidentiality and Nondisclosure:

It is agreed that: 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. 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.

15. Contractor Personnel Security Requirements: Background Investigation – The level of background investigation commensurate with the required level of access is minimum background investigation.

16. Parking: All contractors are required to park in the contracting parking lot, located behind building 122 near the Holcombe Blvd., entrance. Personal or company vehicles left unattended in areas not approved for contractor parking, will be subject to ticketing and towing at the owner’s expense.

17. Insurance:

(a) Workers’ compensation and employer’s liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes.

(b) General Liability: Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000.00 per occurrence.

(c) Property Damage Liability: Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.00.

18. Changes to Performance Work Statement: Any changes to this PWS 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.

During the term of this contract, imaging equipment may be added or deleted from this contract as equipment is replaced, added or removed from service at the facilities. Any such change shall be reflected in a written modification to this contract, signed by the contractor and contracting officer.

19. Below is the list of equipment that shall be inspected (see attached Exhibit 1). The Contractor shall provide a schedule that shows when each piece of equipment is due for inspection.

ENTRY # MANUFACTURER MODEL SERIAL # CSN MFGR. EQUIPMENT NAME LOCATION CATEGORY

1 160811 ARIBEX INC NOMAD PRO 2 XD13093003 6525-439414 ARIBEX NOMAD PRO 2 X 2A355-100 RADIOGRAPHIC UNITS: DENTAL; #2 2 160812 ARIBEX INC NOMAD PRO 2 XD13093005 6525-439414 ARIBEX NOMAD PRO 2 X 2A355-100 RADIOGRAPHIC UNITS: DENTAL; #4 3 160813 ARIBEX INC NOMAD PRO 2 XD13093008 6525-439414 ARIBEX NOMAD PRO 2 X 2A355-100 RADIOGRAPHIC UNITS: DENTAL; #1 4 160814 ARIBEX INC NOMAD PRO 2 XD13093009 6525-439414 ARIBEX NOMAD PRO 2 X 2A355-100 RADIOGRAPHIC UNITS: DENTAL; #3

5 CARESTREAM 1 1009 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

6 CARESTREAM 10 1429 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

7 CARESTREAM 11 1469 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

8 CARESTREAM 12 1664 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

9 CARESTREAM 13 1665 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

10 CARESTREAM 14 1663 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

11 CARESTREAM 15 1666 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

12 CARESTREAM 16 1667 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

13 CARESTREAM 17 1668 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

14 CARESTREAM 18 1662 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

15 CARESTREAM 19 1669 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

16 CARESTREAM 2 1230 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

17 CARESTREAM 3 1233 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

18 CARESTREAM 4 1231 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

19 CARESTREAM 5 1238 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

20 CARESTREAM 6 1237 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

21 CARESTREAM 7 1232 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

22 CARESTREAM 8 1236 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

23 CARESTREAM 9 1430 DRX REVOLUTION 2C400-100 RADIOGRAPHIC UNITS: MOBILE

24 149808 CARESTREAM HEAL CS 9300 AGAZ022 6520-439917 ASEPTICO CS 9300 DEN 2A322-100 SCANNING SYSTEMS: CT: CONE-BEAM: HEAD/NECK 25 141503 FUJIFILM MEDICA XG5000 16150514 6525-439420 FUJI FCR5000 IMAGE R 2C420-100 IMAGE DIGITIZATION SYSTEMS: COMPUTED RADIOGRAPHY 26 141504 FUJIFILM MEDICA XG5000 16250569 6525-439420 FUJI FCR5000 IMAGE R 2C420-100 IMAGE DIGITIZATION SYSTEMS: COMPUTED RADIOGRAPHY 27 31238017 FUJIFILM MEDICA FCR CARBON XL-2 66922244 6525-439420 CARBON XL 2C466-100 IMAGE DIGITIZATION SYSTEMS: COMPUTED RADIOGRAPHY 28 31238016 FUJIFILM MEDICA FCR CARBON XL-2 66922243 6525-439420 CARBON XL 5A232-100 IMAGE DIGITIZATION SYSTEMS: COMPUTED RADIOGRAPHY 29 31238015 FUJIFILM MEDICA FCR CARBON XL-2 66922242 6525-439420 CARBON XL 1A812-100 IMAGE DIGITIZATION SYSTEMS: COMPUTED RADIOGRAPHY 30 142677 GE HEALTHCARE U OEC 9900 ELITE E9-1687 6525-439464 GE OEC 9900 ELITE C- 3A370A-100 R/F UNITS: MOBILE 31 140774 GE HEALTHCARE U DISCOVERY NM 530C 19026 6525-433280 DISCOVERY NM530C VER 2C341-100 SCANNING SYSTEMS: GAMMA CAMERA 32 GE HEALTHCARE U LUNAR IDXA 210553GA LUNAR IDXA BONE DENS 2C251-100 DENSITOMETERS: BONE: X-RAY 33 GE HEALTHCARE U LUNAR IDXA 210552GA LUNAR IDXA BONE DENS 2C252-100 DENSITOMETERS: BONE: X-RAY 34 GE HEALTHCARE U Optima 640 GE 2C249-100 SCANNING SYSTEMS: CT/SPECT 35 152422 GE HEALTHCARE U LIGHTSPEED VCT 64 427523CN6 6525-433280 GE LIGHTSPEED VCT 2C316-100 SCANNING SYSTEMS: CT 36 149242 GE HEALTHCARE U OEC 9900 ELITE E2-2961 6525-439464 GE OEC 9900 ELITE C- 2C438-100 R/F UNITS: MOBILE; 2C-438 37 162402 GENERAL ELECTRI Signa Architect 0000713791VAMR3W MRI SCANNER 1C386-100 SCANNING SYSTEMS: MRI 38 GENERAL ELECTRI Optima MR430S SM07182014-011 GE 1C-398 Extremity MRI 39 General Electric DX 713795VA656 2C450-100 RADIOGRAPHIC SYSTEMS: DIGITAL 40 Hologic ASY-03694 81408167053 Hologic 1B-352 Mammography Stereotactic 41 Hologic Selenia Dimensions 1B-352 Mammography 42 143530 HOLOGIC FLUOROSCAN INSIGH 9091138 6525-439423 HOLOGIC INSIGHT 2 FL 5C346-100 R/F UNITS: MOBILE

43 HOLOGIC FLUOROSCAN INSIGH 19-0915-08 HOLOGIC INSIGHT 2 FL R/F UNITS: MOBILE

44 HOLOGIC Insight FD 30-0518004M Insight FD R/F UNITS: MOBILE MX1755624 45 HOLOGIC Insight FD 30-0518001M Insight FD R/F UNITS: MOBILE MX1755626 46 Hologic ASY-07098 100152 DEXA Hologic 110-226 DEXA 47 130247 IMAGING SCIENCE I-CAT 1CU080775 6520-439917 IMAGING SCIENCES I-C 2A324-100 SCANNING SYSTEMS: CT: CONE-BEAM: HEAD/NECK 48 Instrumentarium FOCUS F9700 EE41237012 Instrumentarium 2A380-100 RADIOGRAPHIC UNITS: DENTAL 49 INSTRUMENTARIUM FOCUS F9695 INSTRUMENTARIUM 2A390-100 RADIOGRAPHIC UNITS: DENTAL 50 MX1301801 Kavo FOCUS F31513 Kavo 2A321-100 RADIOGRAPHIC UNITS: DENTAL 51 MX1301801 Kavo FOCUS F31523 Kavo 2A327-100 RADIOGRAPHIC UNITS: DENTAL 52 MX1300982 Kavo FOCUS F31512 Kavo 2A350-100 RADIOGRAPHIC UNITS: DENTAL 53 MX1300983 Kavo FOCUS F31509 Kavo 2A356-100 RADIOGRAPHIC UNITS: DENTAL 54 MX1300975 Kavo FOCUS F31514 Kavo 2A361-100 RADIOGRAPHIC UNITS: DENTAL 55 MX1300978 Kavo FOCUS F31511 Kavo 2A369-100 RADIOGRAPHIC UNITS: DENTAL 56 MX1301811 Kavo FOCUS F31527 Kavo 2A371-100 RADIOGRAPHIC UNITS: DENTAL 57 MX1301798 Kavo FOCUS F31988 Kavo 2A375-100 RADIOGRAPHIC UNITS: DENTAL 58 MX1301833 Kavo FOCUS F31510 Kavo 2A379-100 RADIOGRAPHIC UNITS: DENTAL 59 MX1300282 Kavo FOCUS F31525 Kavo 2A385-100…