P03 36C242-21-AP-3632_ Chemotherapy Compound JOFOC-s1_Redacted.pdf

36C242-21-AP-3632

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-3632

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Hudson Valley Healthcare Medical

Center Montrose Campus 2094 Albany Post Road Montrose, NY 10548 procuring the requirement for New York Harbor Healthcare System Manhattan and Brooklyn campuses 423 East 23rd Street.

New York, NY 10010 and 800 Poly Place, Brooklyn, NY 11209. 2237 is 630-22-1-024-0001.

2. Nature and/or Description of the Action Being Processed: This procurement is for a firm-fixed price, sole source, 5 year BPA agreement to Optum Pharmacy 801, LLC., (782540202), a large business, for compound drug delivered in final form ready for administration to Veterans with oncology appointments at Brooklyn and Manhattan medical centers. This is back up for Veterans receiving chemotherapy treatment because the NYHHS campus drug hood and preparation rooms are not safe nor compliant for compounding medications. This includes patient specific orders, closed chemotherapy system (equa-shield) pieces directly attached to the preparation, as well as appropriate IV lines and in-line filters.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The procurement is to provide daily chemotherapy compounded chemicals pursuant to a valid order, signed by a VA oncologist, for disease state treatment. The medication must be delivered on the day of scheduled treatment with enough beyond-use-dating to allow infusion of the chemotherapy during the day shift at the infusion suite. The chemotherapy must be shipped in appropriate containers with enough ice packs or dry ice (or equivalent) as needed for refrigeration or freezing based on medication manufacturers’ guidelines. The final product must use Equa-shield closed system transfer devices and tubing required to allow for proper infusion. The 503A pharmacy completing this service must be United States Pharmacopeia (USP) <797> and USP <800> compliant, be certified 503A pharmacy, maintain hood and room certification, and provide VA copies of all certifications, viable particle testing, and competencies on demand. The high-quality pharmaceutical outsourcing (503A) of Optum generates significant savings to customers.

The estimated amount for procurement:

Period of Performance:

Base Year:

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Revision 03 Date: 02/11/2021

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Chemotherapy medication must be purchased because of an unexpected closure of the hazardous compounding area, mainly the Biological Safety cabinet. Contingency plans have been in effect, however, they are not sustainable. Optum was recommended as a suitable 503A facility because they could take on the agency’s daily patient load, they can provide products with the correct closed system transer devices and tubing, they can ensure FedEx delivery in a timely manner, they have all necessary certifications available for VA pharmacy to review, and they are successfully providing service already to several other VA facilities including several within our VISN. In addition, Optum’s highly specialty infusion pharmacy exceeds all USP <797> an USP <800> requirements providing outsourcing pharmacy services for specialized biologic and chemotherapy medications to hospitals and physicians seeking to provide high quality pharmacy care to patients. These are a list of unique specific things Optum can perform:

All products arrive Ready to Administer (admixed, spiked tubing, CSTD, labeled); all pharmacy have to do is administer the medication.

One day turnaround time on all prescriptions.

15-point check system-done by pharmacists on each prescription.

Unit cost, Inventory and supply savings-All drugs provided on a patient specific regimen.

Eliminates drug waste-No drug is wasted as a result of patient specific nature of the compounding.

Staff Time-Elimination of non-reimbursable staff mixing time.

USP<800>-all products mixed in USP<800> compliant environments.

Accordingly, Optum Pharmacy 801, LLC., is the only firm capable of providing the supplies and Services described in Section 3 above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

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Revision 03 Date: 02/11/2021

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In this request, we have not solicited offers from other 503A pharmacies willing to compound chemotherapy and ship overnight for the following day. Optum is the only 503A pharmacy that offers National Institute of Occupational Safety and Health (NIOSH) medications as well as meeting other mandatory requirements. Currently, there are 2 BPA agreements in place with James J. Peters VA Medical Center and Northport VAMC with Optum 801 Pharmacy, LLC.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

CO compared prices paid for individual compound drugs on a Bronx VAMC order back in 2020, to the prices proposed for this order to Manhattan and Brooklyn campuses and found that prices are lower for this requirement than 2020 for most of the drugs used for the compound mixing. This deems the price fair and reasonable, since there is no increase in price. The dollar amount of the proposed acquisition is based on the market rate for medications plus associated labor charges for the pharmacist’s work in compounding the chemotherapy, plus cost for express shipping the medication.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Due to the need to provide chemotherapy with minimal to no interruptions, the market research included asking other VA pharmacies about similar chemotherapy compounding services when they found themselves in similar situations. Searches were also conducted on FPDS, eCMS, VIP and consultation with NCO 22 yielded Optum as a primary provider in this market. At least two NCOs utilized Optum more than once. Contracting Officer also awarded an emergency on 07/09/2021 to Optum 801, LLC, for Manhattan VAMC, and posted an Intent to sole source on Contracting Opportunities from 10/06/2021 to 10/20/2021, there are no other 503A pharmacy vendors that can provide this type of service, so CO did very minimal market research, since there is only one source.

Currently, Optum Pharmacy 801, LLC., is the only 503A pharmacy vendor providing this type of service to VA and meeting the agency’s need.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

We did not identify an alternative source for chemotherapy supplies when we placed our inquiry with other VA pharmacies.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

There were no responses to the Intent to sole source for this requirement.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: