36C25919R0098-0001000.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) 660-19-110 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village

CO

80111 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village

CO

80111 To all Offerors/Bidders

36C25919R0098 04-23-2019

X X X

May 3, 2019 1:00 PM MT.

See Page 2.

The Purpose of Amendment A00001 is to:

a. Answer the submitted questions.

b. Extend the solicitation closing date from 1:00 PM Mountain Time on April 23, 2019 to 1:00 PM Mountain Time on May 3, 2019 Please include Joe Wingfield on your proposal email. Joseph.wingfield@va.gov.

c. Attach the site visit sign in sheet.

d. Solicitation attachment (11535_Horizontal_Laminar_Benches_Apr2015 Specs) is here by removed from this project).

e. All other terms and conditions remain unchanged.

Terminal HEPA 660-19-110 Solicitation Questions

1. Q: What is the delivery schedule for the hoods?

A: Hood purchasing contract is still in progress. Schedule to be determined. The hoods shall take approximately 5 weeks to deliver once ordered.

1. Q: Spec 11 53 00 Horizontal Laminar Flow Benches - requirement for extra material – will owner be furnishing this with the units?

A: 11 53 00 Horizontal Laminar Flow Benches Specifications are to be removed.

1. Q: Will owner be furnishing the shop drawings with the units or prior to shipment of units?

A: ?? The manufacturer should provide manufacturer installation instructions and drawings with the shipment of hoods.

1. Q: Comments were made at the pre-bid about requiring compliance to USP 800. It is noted in the spec. This is a code on handling of drugs inside a pharmacy and does not provide design guidance. Are we to hire a USP 800 expert consultant, and who does the pharmacy use currently?

A: It is the Contractor’s responsibility to ensure compliance with USP 800 standards. It is the contractor’s responsibility to ensure compliance with USP 800 standards. The 2017 USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings elaborates on room pressure requirements for sterile and non-sterile compounding. It would be beneficial to have a USP expert consultant to ensure compliance and correct categorization of rooms with the updated standards.

Pharmacy does not use a USP 800 consultant currently, but below are CETA Certifiers the SLC VA has used in the past:

Andy Testing and Consulting Inc.

Yancy Rod- Intelligent Enclosures

1. Q: Will the addition of HEPA filters impact the control system for the rooms?

A: The addition of HEPA filters should not impact the control system for the rooms. The low-profile filters with a fan were chosen to compensate for any static pressure loss across the HEPA filter. During testing and balancing of the system, the fans should be set to maintain a certain pressure in the rooms according to USP 800 standards and will not need to be integrated into the control system.

1. Q: What are the changes to the control system and who to do that work?

A: The addition of HEPA filters should not impact the control system for the rooms. The fans in the low-profile fan filters should compensate for any static pressure loss across the HEPA filter. The system will need to be tested and balanced after installation to ensure proper air flow. It is the responsibility of the contractor to test and balance the system, and set the fans to regulate the pressure of the rooms per USP 800 standards. After testing and balancing is complete, it is the contractor’s responsibility to ensure the room is certified with a CETA certifier.

1. Q: Has the pressure gradient noted on the drawings changed and if so, to what?

A: The 2017 USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings elaborates on room pressure requirements for sterile and non-sterile compounding. The updated drawing of the space below is based on the information from the USP general chapter, but it would be beneficial to have a USP expert consultant to ensure compliance and correct categorization of rooms with the updated standards.

1. Can MC cable be used to power the HEPA filters?

Yes, if the cable is 10’ or less. It will need to be properly supported every 4 feet and routed up as high as possible.

1. Could you provide a photo of the wall that will need to be moved for installation and disposal of equipment.

1. Q: In the scope of work it was unclear whether or what work is needed to be done on the roof. Drawing detail 3 of M201 Pharmacy mechanical roof plan, shows a supply drop through the roof. Will the contractor need to install/work on the roof at all or have to make a cut through the roof?

A: No work will need to be done on the roof. The roof drawings show the existing system.

1. Q: The drawings indicate that the current supply diffusers are square units (2’x2’). The cut sheets for the new HEPA supply units are 2’x4’. Does the government require a particular orientation of the new rectangular units or is it up to the contractor to install the best orientation?

A: It is up to the contractor to install the best orientation that allows the end users to have access to the electronic speed controllers. A similar 2’x 2’ low-profile HEPA filter is also acceptable if available provided it has an integrated fan.

1. Q: The roof drawing M201 (Detail 3), there is a supply HEPA filter. Is this to be removed (since it is redundant) or is it to remain in place?

A: The existing HEPA filter is to remain in place.

See attached document: 660-19-110 Terminal HEPA Site Walk Sign-in sheet.

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