36C25620Q0681 0001.docx

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) 06-19-2020 n/a N/A none N 36C256 Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531 N 36C256 Department of Veterans Affairs Gulf Coast Veterans Health Care System Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531 To all Offerors/Bidders

36C25620Q0681 06-19-2020

X X

N/A

The purpose of this amendment is to answer contractor questions about the solicitation.

Solicitation close date and time remain the same. This solicitation is NOT extended.

All other terms and conditions of the solicitation remain the same.

See documents that follow page 1.

C.ROBERT ORAVETZ

CONTRACTING OFFICER

VA-VHA-SAOC-2018-7292E378

The purpose of this amendment is to answer contractor questions about this solicitation. Solicitation close date and time remain the same. This solicitation has NOT been extended. Area of consideration/set aside remain the same (Open to VOSB’s only / 100% VOSB set aside). All other terms and conditions of the original solicitation remain the same.

Master List (FINAL) -Contractor Solicitation Questions and Responses Solicitation 36C25620Q0628 Annual Compliance Testing of Diagnostic Equipment-Imaging Modalities Gulf Coast Veterans Health Care System Biloxi, MS

Reference

1.

N/A

“9) Contractor shall complete structural shielding design plans for installation of new diagnostic radiologic and nuclear medicine modalities as well as installation quality assurance testing of all new imaging modalities.” Can the government provide the specific quantity of new modalities that are to be installed each year in the facility. In order to develop a cost estimate for the number of shielding design plans and quality assurance testing that will be needed (on these new modalities) the exact number of new modalities must be known. If an exact number is not known can an expected number (range) be provided (For example, no more than 5 new modalities per year, less than 3 per year etc. etc.).

Structural shielding design plans and quality assurance testing is not needed by the government. Section 1, Item 9 is hereby removed from the Statement of Work and Price/Cost Schedule. Please refer to the revised Statement of Work dated 06/16/2020 that is contained within. Omissions/deletions are on page 2 of the Statement of Work. There are no other changes or additions to the Statement of Work.

Statement of Work Annual Compliance Testing For Diagnostic Radiological Equipment (Imaging Modalities) Gulf Coast Veterans Health Care System (GCVHCS) Biloxi, MS 39531 06/16/2020 Section 1:

1. SCOPE & EQUIPMENT

1.1 Contractor shall provide compliance testing of all imaging modalities in the GCVHCS to ensure each system meets State of Mississippi, American College of Radiology (ACR), American Association of Physicists in Medicine (AAPM) and Nuclear Regulatory Commission regulations.

a) Radiographic (14) /Fluoroscopic Tubes (11) - (25)

b) AEC Devices (25)

c) Dental Radiographic Tubes (22)

d) Angiography/Specials Lab tubes (0)

e) Cardiac Catheterization Lab tubes (0)

f) Computed Tomography Systems (4)

g) SPECT Systems (3)

h) SPECT/CT Systems (2)

i) MRI Systems (2) Note: Testing for the MRI and the Diagnostic Computed Tomography systems shall meet The Joint Commission (TJC) and ARC Accreditation and Performance Testing Standards. See Table A

2) Contractor shall be a currently licensed and American Board of Radiology (ABR) certified diagnostic radiologic and nuclear medicine physicist and shall provide documentation of ABR certification to BIOMED.

3) Contractor shall provide annual compliance testing for 5 Dual Head SPECT systems for Nuclear Medicine. Testing shall meet the Joint Commission (TJC) and ACR Accreditation and Performance Testing Standards.

4) Contract shall perform quarterly calibrations on:

a) Dose Calibrators

b) Well Counters

c) Uptake Unit

d) Survey Meters

5) Contractor shall perform quarterly:

a) Sealed source inventories

b) Sealed source leak tests

6) Contractor shall complete quarterly compliance testing on GCVHCS nuclear medicine cameras in:

a) Posting requirements

b) Radionuclide use and possession

c) Security of Radioactive Material

d) Radiation Protection Program

e) Operating Procedures

f) Performance and documentation of required procedures

g) Personnel monitoring

h) Staff Training and Patient education

i) General Health Physics

j) Radioactive Material Package receipt

k) Waste disposal

7) Contractor shall serve as a consultant in the area of compliance and radiation safety who:

a) Provides prompt assistance with calculation of patient radiation doses from X-Radiation.

b) Provides prompt consultations in determining patient doses in Nuclear Medicine and assisting in determining if the incident is a Medical Event or an Accidental Administration

c) Provides prompt consultations with radiation safety issues that may arise

8) Contractor will provide annual inspections in accordance to TJC and ACR on the imaging equipment listed below in the table – TABLE A

9) Contractor shall complete structural shielding design plans for installation of new diagnostic radiologic and nuclear medicine modalities as well as installation quality assurance testing of all new imaging modalities.

10) Contractor shall check in at the Biomedical Engineering (BIOMED) shop, which is located in the Biloxi facility, Building 1, Room 2B-112 and have proper VA credentials.

11) Prior to commencement of work on this contract, the Contractor shall provide the GCVHCS with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on GCVHCS equipment. Test equipment calibration shall be traceable to a national standard.

12) Contractor will verify and document that each system has met each regulation and provide a field service report (FSR) and/or typed reports and an administrative summary as required by the government for items inspected/tested upon completion of work.

TABLE A

Siemens Uroskop

GCVHCS - Pensacola OP Clinic

NucMed

GE 800 Series

GE DISCOVERY IGS7

PHILIPS DIGIAL DIAGNOST

PHILIPS DIGIAL DIAGNOST

PHILIPS DIGIAL DIAGNOST

Totals Radiographic tubes

Section 2:

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering – Supervisor or designee, Bldg 1 Rm 2B112, phone (228) 523-5720.

B. CO – Contracting Officer. Government Agent authorized to affect contract, contract changes, and issue direction.

C. COR – Contracting Officer Representative. Individual designated by the Contracting Officer to monitor contract performance, and coordinates performance efforts subject to authority limits designated. A designation letter identifying the COR for this project will be issued and signed by all parties prior to issuance of the NTP, or within ten (10) calendar days of contract award.

D. FSE – Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services.

E. ESR – Vendor Engineering Service Report. The documentation/report of services rendered for each incidence of work performance under the terms and condition of the contract.

F. Acceptance Signature – Authorized Department of Veterans Affairs (DVA) employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR.

G. Authorization Signature – COR’s signature; indicates COR accepts work status as stated in ESR.

H. NFPA – National Fire Protection Association.

I. OEM- Original Equipment Manufacture J. ISO- Independent Service Organization.

K. PO- Purchase Order. The VA document that obligates funds. Include this number, as well as the contract number, on all correspondence.

L. GCVHCS- Gulf Coast Veterans Health Care System

Section 3:

3. CONFORMANCE STANDARDS:

Contractor shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, OSHA, and the original equipment manufacturer’s performance standards and specifications.

Section 4:

4. HOURS OF COVERAGE:

A. Normal business hours of coverage are Monday through Friday from 8:00 a.m. to 4;30 p.m., excluding Federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by the COR. Contractor's representative shall check in with Biomedical Engineering upon entering the facility and shall sign in and out of the facility with Biomedical Engineering.

B. Work performed outside the normal hours of coverage at the request of COR shall be billed at the prices listed in the schedule. Billing shall include service time plus travel and exclude parts as they are included in the contract. Work performed outside normal hours of coverage at the request of FSE shall be considered service during normal hours of coverage.

C. Federal Holidays observed by the GCVHCS are:

Or any other day specifically declared by the President of the United States to be a national holiday Section 5:

5. SERVICE MANUALS:

The GCVHCS shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE’s all operational and service manuals, schematics, parts list, etc., which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

Section 6:

6. DOCUMENTATION/REPORTS:

The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices, required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the conformance Standards Section. In addition, each ESR shall at a minimum document the following data legibly and in complete detail:

A. Name of Contractor B. Name of FSE who performed services C. Contractor Service ESR Number/Log Number D. Date, Time (starting and ending), Equipment Downtime and Hours on Site for service call.

E. GCVHCS PO#(s) covering the call, if outside normal working hours.

F. Description of Problem Reported by COR/User.

G. Identification of Equipment to be serviced:

Equipment Inventory ID#, Manufacturer’s Name, Device Name, Model #, Serial #, and any other Manufacturer’s identification #s.

H. Itemized Description of Service Performed (including costs associated with after normal business working hours service), including:

Labor and Travel, Parts (with part #s), Materials and Circuit Location of problem/corrective action.

I. Total cost to be billed.

J. Signatures:

1. FSE performing services described.

2. DVA Employee who witnessed service described.

K. Equipment downtime.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED.

Section 7:

7. REPORTING REQUIREMENTS:

For all on-site service, the contractor shall be required to report to Biomedical Engineering to log in during normal business hours, Monday through Friday. This check-in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(S). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(S) to the COR. All ESRs shall be submitted to the equipment user for an “acceptance signature” and to the COR for an “authorization signature”. If the COR is unavailable, a signed, authorized copy of the ESR shall be sent to the contractor after the work can be reviewed (if requested or noted on the ESR.)

Section 8:

8. ADDITIONAL CHARGES:

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

Section 9:

9. PAYMENT:

Invoices shall be submitted monthly in arrears. Invoice shall have contract number and purchase order identified as well as period of services. Any hourly rate charges shall be itemized as a separate line item, with total cost, on the invoice. Failure to submit a proper invoice shall cause payment delay.

Section 10:

10. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in or repairs required to the scheduled equipment, which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make the necessary repairs.

This contract does not include labor or materials for service lines and fittings, equipment not set forth on this schedule, or operating problems related to environmental conditions, e.g. electrical, steam, water, and/or ventilation that does not comply with equipment specifications. This also applies to improper operation of the equipment by operating personnel.

Repairs made by the contractor, which are the result of neglect or improper operation of the equipment by the medical center, will result in issuance of a separate purchase order by the Government. Contractor must obtain a purchase order in this respect prior to effecting such repairs. Contractor must notify the Biomedical Program Manager and/or his representative prior to this type of repair and secure a purchase order before proceeding further.

Section 11:

11. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment listed in an “as is” condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

Section 12:

12. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business, with an office and full-time staff. The staff includes a “fully qualified” FSE and a “fully qualified” FSE who will serve as the backup B. “Fully Qualified” “Fully Qualified” is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a training program, for the equipment listed in this SOW. For field experience, the FSE(s) shall have a minimum of two years of experience, on the equipment listed in this SOW, or comparable to similar equipment which includes a current American Board of Radiology (ABR) certified diagnostic radiologic and nuclear medicine physicist license.

Section 13:

13. TEST EQUIPMENT:

Prior to commencement of work on this contract, the contract awardee shall provide the GCVHCS with a copy of the current calibration certification of all test equipment that is to be used by the contractor on GCVHCS’s equipment, not later than ten (10) calendar days after contract award.

Section 14:

14. IDENTIFICATION & PARKING:

The contractor’s FSE’s shall wear visible company identification at all times while on the premises of the GCVHCS. It is the responsibility of the contractor to park in the appropriate designated parking areas, to avoid ticketing or towing. Information on parking is available from the GCVHCS Police & Security Section.

Section 15:

15. PRIVACY INFORMATION: The contractor’s employee(s) will secure (in a sealed envelope) and relinquish any documentation found on the VA grounds (either by themselves or others) that contains sensitive patient and/or employee information (i.e. privacy information) to Ms. Melanie Lane, VA Gulf Coast Veterans Health Care System Privacy Officer, Bldg T-102, Room No. A132, Phone: (228) 523-5526. Please contact Ms. Lane within 60 minutes of finding or of receipt of such documents for instructions on what action to take on the documentation. Ms. Lane can also be reached at melanie.lane@va.gov. If Ms. Lane cannot be immediately reached, the documentation will be secured in the Police Office until instructions are received from Ms. Lane.

Section 16:

16. CERTIFICATION AND ACCREDITATION OF CONTRACTOR’S IT SYSTEMS: Certification and Accreditation of the Contractor’s IT System(s) does not apply and a Security Accreditation Package is not required as contractor’s employee will only be utilizing VA owned computers and computer systems.

Section 17:

17. ANNUAL TB TESTING: All contractor personnel providing on-site imaging systems maintenance at the GCVHCS are required to have an Annual TB Test accomplished at the Contractor’s expense. The contractor shall provide written certification of the TB testing on an annual basis and before any employees start work on this contract. New conversions to a positive PPD or new symptoms related to TB, if previously a positive PPD, must be reported to the GCVHCS Occupational Health Department within 10 working days. New hires shall provide certification of TB Testing before starting work at the GCVHCS.

End of Document