36C25923Q0110 0001.docx

36C25923Q0110 Amendment 0001

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) 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

36C25923Q0110 12-02-2022

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 12/07/2022 at 10 a.m. (CST) See CONTINUATION Page The Purpose of the Amendment is to answer the below list of vendors questions with VA responses in RED.

"NIH specification NIH-03-11ZC dated Sept 17, 1974;" is removed from the Performance Work Statement (PWS).

This Solicitations closing date and time is changed from 12/06/2022 at 10 a.m. to 12/07/2022 at 10:00AM (CST).

All other Terms and Conditions remain unchanged.

CONTINUATION PAGE

List of Vendor’s questions for Oklahoma City OK Solicitation with VA’s response in RED.

1. NCI does stand for National Cancer Institute?

Class II biological safety cabinets are divided into four grades, A, B1, B2, and B3. All Class II biological safety cabinets provide personnel, environmental, and product protection. The Class II, Type A cabinet recirculates approximately 70% of the air through a supply filter, and exhausts approximately 30% of the air through an exhaust filter to the room. Type B1 cabinets meet the requirements of the National Cancer Institute (NCI) specification for a General-Purpose Clean Air Biological Safety Cabinet. Class II Type B2 biological safety cabinets are widely used in toxicology laboratories and similar applications where chemical effluent is present and clean air is essential. Class II Type B3 cabinets recirculate approximately 70% of the air through a supply filter, and exhaust approximately 30% of the air through an exhaust filter. The exhaust is directed to the outside through a facility exhaust system.

2. NIH 03-117 cannot be found.

This requirement is deleted.

3. FED STD 209E. This is an obsolete document that has been superseded by ISO 14644. Is it acceptable to utilize ISO 14644? YES

4. SAMA Standard LF10-1980. SAMA is no longer associated with testing and certification of Fume Hoods, it separated from SEFA in 1988. SEFA 1 no covers Fume Hood evaluation as well as ASHRAE. Is it acceptable to utilize another applicable specification? YES, the most current standard available.

5. FDA Insanitary conditions for Compounding is not a testing and certification standard. It is a non- binding document. Its contents briefly describe what testing should be performed and where and when it should be performed. The testing for pharmacy cleanrooms and primary engineering controls are contained in the USP 797/800 standards and the CAGs. Is this document being considered a standard? YES

6. Please clarify, what is a Bariatric Hood? Can make and manufacturer be provided?

4F115 Nuaire BSC Class II Type A 4F115b Nuaire BSC Class II Type A 4F115c Nuaire BSC Class II Type A 4F133 Nuaire BSC Class II Type A 4F137 Nuaire BSC Class II Type A 4F105 Nuaire BSC Class II Type A 4F105 Nuaire BSC Class II Type A 1A105j Sputum Induction Chamber “AeroMed) 5F116 Bronch Room (Ceiling HEPA filter) 5F144 Backup Bronch Room (Ceiling Hepa filter) BF132/BF133 Isolation Room (HEPA filter) GA142 Baker Sterilshield glove Box GA 142a1 Baker Edgegard Laminar (2) GA142b1 Steril chemgard Chemo (2) GR102 Chemoshield Barrier Osilator glovebox

7. Under LAFW entry, is this in reference to laminar flow hoods utilized in the pharmacy? If yes, ACGIH is not an applicable source. Please provide additional guidance as to what ACGIH is referencing. American Conference of Government Industrial Hygiene. This should be anti-room standards for Chemo/IV mixing areas.

8. Please provide model identification of the hoods in the Path Lab Testing portion. Are these all BSCs or another type of hood? See Number 6. Answer

9. What testing requirements are to be utilized for the Sputum Booth? Testing for negative pressure and filtration system.

10. What are the testing requirements for the Isolation rooms? Negative Pressure/Ceiling filtration if it applies 36C25923Q0110 Amendment #1 VAMC Oklahoma City OK