36W79719R0001-0001000.docx
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- Pharmaceutical Prime Vendor 2020 Federal contract opportunity
- Solicitation number
- 36W79719R0001
About this file
This document contains a pre-solicitation notice and related questions and answers for a Pharmaceutical Prime Vendor solicitation. The solicitation will be for just-in-time distribution of Government contracted pharmaceuticals to VA facilities, other Government agencies, and State Veterans Homes in multiple locations. The base performance period is 2 years with three 2-year option periods. Offerors must have logistics capabilities and experience to service approximately 750 customers with next-day deliveries of thousands of pharmaceutical items. The solicitation will require web-based ordering, inventory management, consolidated paperless invoices, barcoding, and reporting capabilities. The net cost will combine awarded distribution fees and established product prices from FSS contracts, VA National Contracts, BPAs and BOAs. The NAICS code is 325412 and small businesses must have 1,250 employees or fewer. The solicitation will be issued on September 12, 2019 with a closing date of October 29, 2019 and can be found on FedBizOpps. Questions should be directed to the specified contracting officer.
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37W79719R0001 AMENDMENT 1
37W79719R0001 AMENDMENT 1
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 ADM
INISTRATIVE 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 d ate 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 3
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) 09-18-2019 003A4C Department of Veterans Affairs National Acquisition Center (003A4C4) Building 37 1st Avenue, One Block North of 22nd St.
Hines IL 60141 003A4C Department of Veterans Affairs OA&L National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141 To all Offerors/Bidders
36W79719R0001 09-10-2019
X X X
X Responses to questions received regarding this RFP are provided in pages 2-3.
| Section |
| Page Number # |
| Paragraph |
| Question |
| Response |
| B |
| 27 |
| I-4(g) |
| Can the VA provide a U.S. Code citation for the Internet Security Act? |
| Guidelines for the VA firewall can be found in VHA Handbook 6500.11 and guidelines on secure external connections can be found in VHA Handbook 6513. Both Handbooks provide references to applicable US Code, shown below. |
a. Federal Information Security Modernization Act (FISMA) of 2014, 44 U.S.C. § 3541 et seq., (P.L. 113-283), December 2014;
b. Department of Veterans Affairs Information Security Enhancement Act of 2006, 38 U.S.C. § 5721 et seq. (P.L. 109-461);
| B |
| 23 |
| I-1(l) |
| The RFP states that WBPG items must be "FDA Approved." Please confirm that for this purpose “FDA Approved” includes all products that comply with a final monograph or tentative final monograph promulgated by FDA under its OTC Drug Review Procedures in 21 C.F.R. Part 330 (monograph pharmaceuticals). There are many monograph items on the VA's FSS contracts. |
| The interpretation here is correct. For prescription drugs, the drugs must be FDA approved. For OTC products, products that comply with a final monograph or tentative final monograph promulgated by FDA under its OTC Drug Review Procedures in 21 C.F.R. Part 330 would be included, as these products do not go through a traditional process for FDA approval. |
Schedule of Suppliers/Services
| 5 |
| Purpose |
| The RFP states that non-contract (i.e., open market) items are excluded from the contract. Please confirm that it is the PPV contractor's responsibility, and not the VA's, to ensure that only contracted items can be ordered on the PPV contract and that contracted items will not be ordered on the open market. |
| Correct – it is the responsibility of the PPV to assure that only contracted items are visible to be ordered on the accounts that are associated with this contract and that all contracted items are visible on the accounts associated with this contract versus the open market when possible. With that said, it is the VA’s responsibility to assure that the file of contracted prices is accurate and to correct any discrepancies as quickly as possible. |
| Schedule of Supplies/Services |
| 6 |
| Type of Contract |
| The VA has made an important change to the type of contract. In the current contract the VA expressly excluded from the "Requirements" contract obligations WBPG and medical surgical items. However, this RFP only excludes the WBPG items from the Requirements obligation. Please confirm that medical surgical items (listed in Section.7, I-1.f, paragraphs 1-3) are Requirements items. If the treatment of these items is changing, please provide projected usage for the contract. |
| This understanding is correct. Med Surge items that are made available for this contract are requirements contracts, and WBPG items remain optional. For this contract, only those med surge items which are competitively bid via a national contract will be available for procurement through the PPV. Other med surge items will need to be procured from other sources. At this time, VA is just beginning the process of contracting for these items, so it is impossible to give usage, as it isn’t completely known which items will be contracted for. Several of the high usage items are included in the purchase data that was sent out with the solicitation (glucose tests strips, lancets, alcohol prep pads, etc), so VA recommends reviewing the items on that list for an idea of usage, as these are likely the first contracts that will be worked on due to high usage. |
| I-4 Electronic Ordering System |
| 31 |
| b: |
| The PPV is asked to provide software and scanners to support serialization "(which is required now)" and 2D bar codes. Does the VA acknowledge that the FDA has provided grandfathering of older unserialized DSCSA products until they expire and also is granting waivers, exemptions and exceptions from the DSCSA product identifier requirements? Do they acknowledge that they may be receiving unserialized DSCSA products for an period of time in to the future? |
| Yes, VA does realize both points, which is why the section actually reads (emphasis added): |
a “The system must be able to support serialization (which is required now) and 2D barcodes, when the 2D barcode standard is deployed as required in the Drug Supply Chain Security Act (DSCSA).”
| I-16 Delivery |
| 49 |
| .h |
| The NIOSH provides two lists of "Hazardous Drugs." NIOSH publishes Table 1 Antineoplastic Hazardous Drugs and Table 2 Non-Antineoplastic Hazardous Drugs. However, the USP 800 regulation, which details the requirements for handling Hazardous Drugs, only requires special receiving and storage of some of the products on Table 2. Finished dosage forms that require minimal manipulation in the health care setting are allowed to be shipped and stored with regular Rx products. Please confirm that the VA’s special handling requirements in section I-16(h) are consistent with the USP 800 regulation and will not require special handling beyond USP 800? |
| That is correct. VA uses both USP 797 and USP 800 as the regulations to support practice, so VA would not require anything more stringent than the USP 800 regulations. |
| I-16 Delivery |
| 50 |
| k: |
| Will the VA be assessing the extent of the damage and the risk involved when tendering damaged containers mark as containing NIOSH to minimize driver and those outside the healthcare entity? Would a visibly leaking container discovered by the VA be mitigated first or would it be tendered to the driver with the expectation that the driver mitigate any exposure when removing the container from the facility? |
| If there is visible damage to containers marked as containing NIOSH products, VA will not accept those containers from the driver. With that said, VA would work with driver to mitigate immediate risk (i.e. cleaning up spill, etc.), as it is realized that the driver doesn’t likely have the appropriate materials on hand to mitigate. |
| Attachment D |
| Attachment D |
| none |
| Please provide the time period that was used for the usage data presented in Attachment D. |
| May 2018 through April 2019 |
| Attachment D |
| Attachment D |
| none |
| What 12-month period is covered by this data? |
| May 2018 through April 2019 |
| Attachment D |
| Attachment D |
| none |
| The unit of measure says NDCUnits. Is this doses, or bottles? For example, the NDC for the following product represents a 100-ct bottle. Are the reported sales under NDCUnits 1,256 bottles of 100ct, or just 1,256 capsules total? |
| PPVItemNUMBER |
| ndc |
| Description |
| 1660877 |
| 59746038306 |
| TERAZOSIN HCL |
1MG CAP – 100ct
NDC unit = commercial package size in which NDC is distributed by, so in this case, it would be 1,256 bottles of 100
| Attachment D |
| Attachment D |
| none |
| Are the purchases those made against an FSS contract only, or does it include all sales to VA entities made through the Prime Vendor? |
| All purchases through the prime vendor for items that are on a contract (FSS, national contracts, etc.). No open market purchases are included. |
| Attachment D |
| Attachment D |
| none |
| Do these purchases include National Contracts, including those administered through the DOD? |
| National contract purchases are included for both VA and DoD administered contracts |
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