36C25622Q0462 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 NUMBERE

D 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 amendmen t, 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) 36C256 Department of Veterans Affairs Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531 36C256 Department of Veterans Affairs

VHCSO &

Network Contracting Office 16 400 Veterans Avenue Biloxi MS 39531 To all Offerors/Bidders

36C25622Q0462 08-23-2022

X X X 8-31-2022 2 pm CT X Amendment is hereby issued to provide answers to questions and in response to questions, revisions to both the Price Schedule and Performance Work Statement (both attached), and also adds ATT D4.

No extension to due date of offers.

REMINDER: Return this amendment signed with offer

Melanie Hawley Contract Specialist

VA-VHA-2020-AC34AE75

36C25622Q0462 -Questions and Responses/Answers:

1. How are the quantity and unit defined in B.2 PRICE/COST SCHEDULE?

For example, Appendix A _VHSO Equipment and Locations on page 40 shows 3 CT units at the main campus, but item numbers 1003-5003 CT Annual Testing show quantity 9; two CT units for Outpatient clinics (Gene Taylor 1 and Fort Smith 1), but item numbers 1004-5004 CT Annual Testing for Outpatient clinics show quantity 12.

Similarly, please provide clear definitions for item numbers 1005-5005, 1006-5006, 1013-5013, 1014-5014, 1016-5016, 1017-5017.

Response: The qty is the estimated hours to complete the work. The difference between 1003 for three CT units estimated taking 9 hrs and 1004 with two CT units estimated taking 12 hrs is that for 1003, all three units are centrally located at the main campus and the work is generally done more efficiently. For 1004, the work is divided between two different geographic locations and the efficiencies are not realized so we estimated more time needed.

For 1005 vs 1006, the estimate is 8 hrs per annual testing per MRI unit, two of which are at the main campus and one at a different location.

For 1013/1014: 1013 is the estimate for the annual testing of Nuclear Medicine units and 1014 is the estimate for all the quarterly testing.

For 1016/1017: this is an estimate of the hours that might be needed for consultation, attending RSC meetings, reports, etc.

2. For item number 1015-5015, Testing of replacement CT/X-ray tubes prior to patient use, I do not think there is any requirement from the JC, IG, NRC and NHPP to test a replaced CT/X-ray tube prior to patient use. A typical requirement is within 30 days. Please advise.

Response: Yes, we should change this. The requirement is within 30 days of replacement. Price Schedule revised accordingly and attached.

3. For Item Number 1007-5007 and 1008-5008, will there be a new CT unit and new Diagnostic unit every year? I do not think so, but I would like to know how to fill out the price for these items.

Response: Not necessarily, although we are at or near end of life for some of our x-ray equipment. We are phasing in the equipment replacements and are working with biomedical engineering to get the work done. We do expect one and possible two new x-ray rooms to be completed within the first year of the contract. Our replacement schedule has yet to be approved for the other units but potentially we could be replacing one or two x-ray units each year. We do not anticipate needing to replace CT units during the timeframe of this contract, but we included the line item in case we need to add equipment if new service lines are added (for example, lung cancer screening). The line items were included in case we need to use them and are an estimate. We believe we have enough room built into the contract to support work needed.

4. B.3 3.0. Performance Requirements 3.1.8. Provide technical advice and direction during the performance of American College of Nuclear Physicians (ACNP)- Society of Nuclear Medicine (SNM) Nuclear Medicine phantom studies.

Are those phantom studies part of the annual testing or additional research/patient studies? Is the technical advice and direction provided in person on site or can it be done remotely?

Response: VHSO will occasionally participate in Patient Simulator (Phantom) Programs as part of a comprehensive quality assurance program. These are not on any set time rotation but average roughly one per year. The procedure is performed by the NM Technologist with guidelines provided by the participating body (ie SNMMI, ACNP, etc…). Technical advice may be sought as it pertains to nuclear physics from the Physicist. This technical advice can be provided remotely.

5. B.3 3.0. Performance Requirements 3.1.9. Assist the Nuclear Medicine Physician with dosimetry monitoring as related to radio pharmaceutical therapy and provide physicist support to Nuclear Medicine for therapy as needed in accordance with the Release Guidelines.

Does any of the site in Appendix A _VHSO Equipment and Locations perform any radio pharmaceutical therapy? Please provide us with detailed information about the radio pharmaceutical therapy, if any. Is the assistance to be done on site or remotely?

Response: VHSO performs I-131 outpatient thyroid therapy (not to exceed 30mCi) and I-131 WB. Combined, these exams are performed an average of 3-4 per year. The assistance requested may be performed remotely.

6. B.3 3.0. Performance Requirements 3.1.14. Conduct Quality Management surveys related to NRC/NHPP requirements.

Please specify Quality Management Surveys.

Response: The Quality Management Survey is another name for our Written Directive/Therapy Program. Attached is the procedure guide for this program. The frequency, scope, and responsibility of the Physicist can be found in Section I “ANNUAL REVIEW”. (See Attachment D4)

7. for Dental Pro Max 3D at main campus and Gene Taylor OPC, are they treated as regular Panoramic (Pano) dental units or Cone Beam CT (CBCT) dental units?

Testing for Pano and CBCT is different and therefore pricing is different.

Response: This equipment is used as regular Panoramic dental units about 75% of the time and as CT units about 25% of the time.

8. Is Philip Epic 7 G at Jopin CBOC an Ultrasound unit?

Response: Ultrasound and is removed from the list. PWS revised and is attached.

9. Page 9, CLIN 1015 “prior to patient use” - Newly repaired equipment does not fit the category of emergency. X-ray tube and other component repairs are routine occurrences which are expected to occur over the lifetime of the unit. Repaired systems undergo scrutiny by the engineering servicer and oftentimes by automated self-checks integrated within the device software, in addition to QC performed by technologists. For equipment repairs on imaging equipment that would require a physicist follow-up, contract physicists ensure that the VA complies with federal policy established in the relevant VHA directives (1105.04, 1105.05, 1129). These corporate policies comply with every national regulatory, guidance, and relevant accrediting body such as the ACR standards for accreditation, the Joint Commission standards, the Council on Radiation Control Program Directors (CRCPD) Suggested State Regulations (SSR), and Federal Guidance Report 14.

Success occurs when as much notice is given to the physicists as possible in the event of an x-ray repair or replacement so they can schedule staff appropriately. We do not recommend shutting down a unit in the event of routine repair until a physicist can survey it, that practice is deprecated and is no longer supported by VHA, TJC, ACR, CRCPD, or any other national body in the diagnostic imaging industry. Current industry practice is using a 30-day window for physics follow-up following the repair of diagnostic imaging equipment. We recommend adjusting the CLIN to “Testing of replacement CT/X-ray tubes NLT 30 days after the repair has been completed.”

Response: We agree with this recommendation. PWS revised and is attached.

10. Page 10, CLINs 1016 & 1017 – are these quantities reflective of anticipated contractor hours or # of reports? If the latter, then would the VA clarify those deliverables with the table on Page 32, section 5.0 of the PWS?

Response: This is intended for contractor hours that might be needed for consultations and guidance requested as outlined in 1.2.2, 1.2.3, 1.2.4, 1.2.5. Also, for the administrative component of the reports in the deliverables table in 5.0. that is not included during the actual annual or quarterly inspections/evaluations.

11.Page 27, Paragraph 1.2.2 - Are we to assume that PWS items 1.2.2 and 1.2.3 activities are to be covered under CLIN 1016, or will these be quoted separately?

Response: Yes, will be covered under CLIN 1016 or CLIN 1017 as appropriate.

12. Page 27, PWS item 1.2.5 – would these assignments from the RSO be covered by CLIN 1017, or will they be required to be quoted separately?

Response: Yes, would be covered under CLIN 1016 or CLIN 1017 as appropriate.

13. Page 27, Paragraph 2.1 - recommendation for the VA to change the word ‘licensed’ to ‘qualified’ using the definition provided by the American College of Radiology. Medical physicist licenses are issued by a select few states (NY, TX, FL). As a federal institution, it would be incorrect to have state rules provide governance.

Response: We agree with this recommendation. The qualification standards are listed in 2.1.2 through 2.1.7. PWS revised and is attached.

14. Page 29, Paragraph 3.1.8 – Best practices for use of phantoms in nuclear medicine is provided by the American College of Radiology. We recommend that this language be changed from ACNP-SNM to ACR testing for Nuclear Medicine facilities.

Response: It is appropriate to make the above changes. The Phantom that is used at VHSO for the above is the Jasczak Phantom. We are requiring the Physicist perform the phantom testing on both NM Cameras during the quarterly visit. PWS revised and is attached.

15. Page 42, Appendix B – are annual lead apron checks a requirement of this contract? If so, are we to assume they fall under CLIN 1016? For an accurate quote, what is the estimated lead apron volume?

Response: Our staff perform the lead apron checks. The physicist and the Radiation Safety Committee review our written process as defined by our SOP, every two years, and votes on approval. We may ask for guidance from the physicist if we find a need to change our process. We may also ask for guidance from the physicist if we find defects. The number of lead aprons currently at our facility is 68.

16. Noted that Addendum to FAR 52.212-2 Evaluation – Commercial Items was duplicated in Section E of solicitation; which one are we to abide by?

Response: Use and follow E.6 and please disregard E.7.

See attached document: ATT 1 Am 1 - B2 Price schedule revised 02.

See attached document: ATT 2 Am 1- B3 PWS revised.

See attached document: ATT D4- Written Procedure for Written Directive.

Amendment 1 Solicitation 36C25622Q0462 Medical Diagnostic Physicist End of Document