36C24819Q0468-0003000.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)

NONE

Y Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa

FL

33637 00248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Tampa

FL

33637 To all Offerors/Bidders

36C24819Q0468 04-29-2019

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to:

5/16/19 at 5:00 pm.

The purpose of this amendment is to provide questions and answers (See Continuation Page).

Answers are written in "Red" texts.

Please note that Amendment 0002 and 0003 are the same.

Paul Jarrett Contracting Officer

CONTINUATION PAGE

Questions and Answers Question 1 The PWS provides inadequate detail with regard to hazard drug surface sampling. Section 4.1.7 states, “Environmental wipe sampling for hazardous drug (HD) surface residue should be performed routinely as outlined by USP <800> for those facilities listed in appendix A. Results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as results are available.”

The PWS fails to indicate the type of drugs to be sampled, the number of samples to be collected at each facility and the location of each sample to be collected. The line item pricing indicates a quantity of 100 samples for the contract year. Some vendors may interpret this as 100 individual wipes to be analyzed for a single HD. Others may (more realistically) interpret this as 100 individual samples to be analyzed for the top 5-10 HDs. Please provide more detail so that each vendor can price this fairly. I have included an section pulled from the PWS from a different VISN as a useful reference. It provides the level of detail that enabled the vendor to provide ‘apples-to-apples’ offers with respect to the HD sampling. Please use this example as a clarification.

“A.3.5.4 Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually (e.g. every 6 months), or more frequently as needed to verify containment. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs.

The drugs required for testing include:

Cyclophosphamide Ifosfamide Methotrexate Fluorouracil Platinum-containing drugs Additional Drugs o Additional drugs may be requested based upon identified need per site.

o Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

Surface sampling will include the following areas:

Interior of PEC and equipment contained in it.

Pass-through chambers Surfaces in staging or work areas near PEC Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area) Areas immediately outside the hazardous drug buffer room or C-SCA Patient administration areas”

Question 2 Annex A indicates that HD surface sampling is to occur at all the facilities. Please confirm that all facilities actually compound HDs. For instance, we understand that the Viera facility does not have a negative pressure segregated compounding area (or buffer room) within which to compound HDs, yet Annex A indicates that the vendor should perform surface sampling for HDs at that facility. Additionally, is the intention to perform the HD surface sampling annually or semiannually? Viera will have a negative pressure area after construction is complete. HD surface sampling will be at the request of each individual facility. The intention is to perform a baseline assessment then every 6 months and/or more often if the facility requests.

Question 3 What is the physical address of the VISN 8 mobile trailer?

This will depend upon where it is located when due for certification. Currently, this is still being manufactured with the first delivery station planned for Tampa, FL.

Question 4 Section 4.1.4.4. states, ”Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation (s). Additional smoke tests will need to be performed in rooms without low air returns. A video of the smoke test must accompany the report.” It is understood that each smoke visualization studies must be performed for each PEC in accordance with CAG-003-2006. However, additional information is needed with regards to the room smoke tests. The line item pricing indicates a quantity of 40 room smoke tests. Annex A does not indicate which rooms, if any, have low air returns. Please provide a list showing the quantity and location of each room which will require the semiannual smoke visualization testing so that this can be priced effectively. This is in the attachment Appendix A under column “K”

Question 5 Section 4.1.6. states, “Viable Surface Monitoring: Each classified area including the interior of the PEC (including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass through chambers must be sampled at least monthly.” Line item 12 has a quantity of 1,560. Is the intention of line item 12 to cover one single surface sample (for a total of 1,560 samples) or is the line item to cover an area of samples. For instance, a clean room with a PEC inside of it may require 4-5 samples and the PEC in that room may require an additional sample. These 5-6 samples would be a quantity of “1” on line item 12. So this would mean there may be up to 8,000 samples collected in a given year. Which is the intended interpretation of the 1,560 units on line item 12?

Would consider this one AREA of samples.

Question 6 Section 4.1.4.2 states, “HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.” The line item pricing indicates 120 HEPA leak tests per year. Please provide a list with the following information so that the testing can be priced more accurately:

1. Number of HEPA filters at each location

1. Is the HEPA filter mounted in the ceiling diffuser? In a HEPA box above the ceiling or in an interstitial space? Within an air handling unit? (HEPA filters installed in an air handling unit or in an interstitial space are typically more difficult to access and test and are priced differently)

1. For each HEPA filter, is there an upstream aerosol test port installed which would allow the test aerosol to be injected upstream of the HEPA filter? (HEPA filters without installed upstream aerosol test ports are typically more difficult to test and are priced differently) Vendors should list prices per item, as there are multiple areas currently undergoing both design and construction. The HEPA filter number and access may change at any given time.

Tampa:

Current state:

2 HEPA filters->1 HEPA mounted in the ceiling diffuser in the Anteroom, no port access (accessible room side). 1 HEPA in the ACHU cavity (supplies the other two rooms) with port access

Future (short term) state:

Possible addition of another HEPA FFM box in the anteroom-no port access

Future (new build) state:

8 total, all in ceiling with port access requested

Gainesville:

15 total, 14 mounted in ceiling diffusers, 1 within the air handling unit Regarding ports:

2. 4 currently without port installed but being upgraded within the next 6 months to include ports

2. 1 in anteroom with a separate port

2. Awaiting construction completion in hazardous satellite, but 5 HEPAs will be ordered with aerosol ports, air handler unit does not have port

2. 4 HEPA filters do not have the aerosol port

Lake City:

Current state: Gloveboxes only Future state: New build of cleanroom still in design phase, but would plan for 3 HEPA filters in the ceiling diffuser with access ports requested

Miami:

Current state:

7 HEPA filters all mounted in ceiling with port access

West Palm Beach

1) Number of HEPA filters at each location that compounds CSP: Total of 4 1 located in the infusion center roof top unit 2 located in interstitial above inpatient hazardous clean room 1 located in interstitial above inpatient non-hazardous clean room

2) For each filter:

a. Is the HEPA filter mounted in the ceiling diffuser?

b. In a HEPA box above the ceiling or in an interstitial space? 3 interstitial space

c. Within an air handling unit? 1 mounted within roof top unit

3) For each HEPA filter, is there an upstream aerosol test port installed which would allow the test aerosol to be injected upstream of the HEPA filter? Test ports in interstitial space and on the roof top. No test ports above the hood in clean room Bay Pines

Bldg 100 Rm 1C-126 – 5 HEPA filters Bldg 100 Rm 5A – new construction - 6 HEPA filters All filters within ceiling diffuser No testing ports on filters.

San Juan

See attached document: Appendix A MFT_GFT Site Requirements.

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