S06 AMEND 36C24820Q1393 0001.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 6

09/03/2020

516-20-3-213-0108

36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

Room 315, Bldg. 2

10,000 Bay Pines Blvd

Bay Pines FL 33744

36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

C.W. Bill Young VA Medical Center

10000 Bay Pines Blvd. Room 315, Bldg. 2

Bay Pines FL 33744

To all Offerors/Bidders

36C24820Q1393

08-14-2020

X x x x

The purpose of this amendment is to answer questions posed.

***See Attached***

Janice Fornaro

CONTINUATION PAGE

QUESTIONS AND ANSWERS

Question #1:

In order to reduce turbulent airflow in the sterile environment, is it a requirement for the IVWMS hardware comprised of a single device rather than multiple components?

Answer #1:

While not a requirement, a single device would exceed the expectations of this bid and satisfy the requirements of the service.

Question #2:

Are all components of the IVWMS required to reside completely within the compounding area

(ISO5 environment) to reducing risk of external contamination?

Answer #2:

It depends on the definition of “IVWMS.” Minimal equipment should be placed within the hood and surrounding classified areas to reduce the risk of turbulent airflow and contamination. We prefer the pieces of IVWMS needing to be completed by pharmacy technicians to be contained within the ISO 5 environment, with capability for remote verification at a different computer in an unclassified space.

Question #3:

To minimize downtime, is the IVWMS hardware maintenance required to be provided by a single vendor or multiple vendors?

Answer #3:

The impact of “multiple vendors” would negatively reflect hardware maintenance/support. We intend to choose a single vendor for this project.

Question #4:

What authorized sources are utilized for drug density data to populate the gravimetric database

(i.e. manufacturer, laboratory certificate of analysis, other)?

Answer #4:

Manufacturer and/or laboratory certificate of analysis, other as approved by compounding and pharmacy management.

Question #5:

How many line items does the drug database contain, and how frequently is the density database updated to add new medications required for gravimetrics?

Answer #5:

Currently 402 additives 238 solutions (640 total, though the actual number may be less). The frequency of updates would be anytime a new item is added.

Question #6:

Who maintains/ will maintain the clinical data contained within the drug database (i.e. pharmacy technician, pharmacist, other)?

Answer #6:

Pharmacist; compounding program manager

Question #7:

Will the IVWMS’s drug specific compounding workflows have a requirement that they can be customized to include specific and specialized instructions for complex preparations (i.e. high risk or medications requiring special manipulations)?

Answer #7:

Our facility does not practice high risk compounding, but for medications requiring special manipulations customization would be important to our service.

Question #8:

Is it a requirement that the device be equipped with advanced imaging to support visibility of any foreign materials in a preparation (i.e. particulates, coring, bubbles) essential during remote pharmacist verification?

Answer #8:

I am not sure this was a written requirement, but this function would improve safety of verification and is preferred by the service.

Question #9:

Will the IVWMS be required to self-advance to promote efficiency and reduce contact with the

IVWMS during the compounding process?

Answer #9:

This can be discussed with the awardee of the contract, we do not necessarily want to self-advance if harm may come as a result.

Question #10:

Will the facility/pharmacy staff require real-time reporting capability to allow for immediate access of compounding records during a medication recall or regulatory body audit?

Answer #10:

We require recordkeeping with real time ability to audit.

Question #11:

Reference: IV Salient Characteristics

Must be able to perform in-line verification prior to mixing ingredients

Question: XXXXXXXXXXX’s precision-based technology of gravimetric analysis reduces the reliance of visual checks, including the pull-back method. In-line dose verification is not a recommended first-line method of dose verification, as it relies on volumetric methods to identify preparation gaps. XXXXXXXXXXX’s customers typically use volumetric preparation for very few drugs, and on an as-needed basis without an in-line check. ISMP’s 2020/21 Best Practices recommend the use of gravimetric verification for all sterile compounding. XXXXXXXXXXX is currently reviewing development efforts to offer a visual verification pause during compounding per customer feedback. Will VA Bay Pines accept the current use gravimetric verification as a frontline verification method, as recommended by ISMP’s 2020/21 Best Practices?

Answer #11:

Yes.

Question #12:

Reference: 9. Trainings

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber

Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST

Special Publication 800-16, Information Technology Security Training Requirements.]

Question: In order for XXXXXXXXXXX to adhere to the training responsibilities, will VA Bay

Pines provide all required course and URL locations to XXXXXXXXXXX?

Answer #12:

Yes, sending TMS links for training I would think is the project Point of Contact (POC) at the

VA’s responsibility to ensure the contract does privacy & security, etc.

Question #13:

Reference: 9. Trainings

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

Question: Will VA Bay Pines allow XXXXXXXXXXX to meet training requirements as outlined in the provided MOU ISA, section 3.2.12 Training and Awareness as well as completing background investigation training through TMS as needed?

Answer #13:

Yes.

Question #14:

Reference: 9. Trainings

The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Question: All of our associates go through the necessary vendor credentialing, however, the project team may not be identified within a week of the initiation of the contract. Will

XXXXXXXXXXX be allowed to provide the personnel names once the project team has been identified?

Answer #14:

This is acceptable as contractors do not know who will be on the project now but will know closer to the date if they get the award.

Question #15:

Reference: Section B.2 Delivery Schedule

Delivery, installation and implementation shall be completed by 11/30/2020.

Question: New IV Prep implementations take approximately 6-9 months from project kickoff to completion of implementation. During the planning stage of the Pyxis implementation project, the PM team will work with the VA to develop a mutually agreeable timeline. Will the VA modify the requirement for installation to be completed by June 30, 2021?

Answer #15:

A longer timeline and understandable with data validation and workflow implementation timeline may be pretty long, an end date of June 30, 2021 is reasonable and accepted.

No further questions will be answered. The question period ended 09/01/2020 at 3 PM EST.

This solicitation closes on 09/11/2020 at 3 PM EST.