36C24419C0131-001.pdf

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-19-AP-1862

1. Contracting Activity: : Department of Veterans Affairs, VISN 4, Corporal Michael J. Crescenz VAMC, 3900 Woodland Avenue, Philadelphia, PA 19104. Transaction number: 642-19-2-315-0097.

2. Nature and/or Description of the Action Being Processed: The Philadelphia CMCVA Medical Center is seeking to upgrade its currently used Olympus EBUS system purchased 6 years ago. EBUS technology over the last 6 years has exponentially evolved into improving the staging of lung cancer.

Estimated cost is $347,725.98.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Endobronchial ultrasound-guided Tran’s bronchial needle aspiration (EBUS-TBNA) has emerged as a minimally invasive technique for evaluating the mediastinum and staging patients with lung cancer. In the hands of an experienced operator, the procedure is safe and provides excellent sensitivity, specificity, and predictive diagnostic values. In conjunction with endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), a nearly complete mediastinal evaluation can be performed in a minimally invasive fashion. This strategy results in improved lymph node staging, markedly reduced need for mediastinoscopy, and fewer futile thoracotomies compared with a traditional surgical staging procedure. The procedure is cost effective and provides excellent cytological specimens that have proven well suited for ancillary testing, such as immunohistochemistry and tumor genotyping. EBUS- TBNA, initially used as a tool to sample the lymph nodes adjacent to the airway walls, has now become instrumental in sampling lesions in the mediastinum, hilum, and lung parenchyma, where previously more than 1 procedure would have been necessary. Looking forward, expanded use of this procedure is likely to revolutionize the access to cytology-proven staging and restaging of lung cancer and other thoracic malignancies in a minimally invasive fashion.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

https://www.philadelphia.va.gov/

OFOC SOP Revision 08 Page 2 of 3

Revision 08 Date: 04/18/2018

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Olympus equipment (Endoscopes) is the standardized equipment used at the Philadelphia VA Medical Center by the G.I.

Suite, ENT, Pulmonary and Surgery departments. Philadelphia VA Surgeons, Pulmonologists and ENT Specialist are trained in the operational use of Olympus Endoscopes, which is highly specialized equipment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Contacted Olympus America Inc., directly to identify any SDVOSB distributors of this product.

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

Reasonable: Market research showed that the prices offered for this product by Alliant will be the same as, or lower than purchasing direct from Olympus. Since Alliant is an SDVOSB, this will also help with the VA’s socioeconomic goals of awards to SDVOSB’s.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was performed by searching GSA and NAC.

The product was not found to be available under NAC contract. However, correspondence with Olympus America revealed Alliant Healthcare to be the only authorized SDVOSB reseller for this product. As such, since Alliant Healthcare is an SDVOSB, in accordance with VAAR 819.7007 (b), a sole source award to Alliant Healthcare is justified.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Per VAAR 819.7007

(a)(1)(2)(3)(4)(b), A contracting officer may award a contract to a verified SDVOSB concern using procedures other than competitive procedures provided the conditions cited in the authority are met. Additionally, VA has awarded several contracts to Alliant Healthcare for Olympus America products. Due to the specialized nature of this equipment and those that are skilled professionals using it, replacing this equipment would result in patients’ appointments and procedures being cancelled or postpone while the staff gets trained. This additional time and money would be a detriment to patient care.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None

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: For future procurements of this nature, we will continue to conduct market research by checking availability on GSS, FSS Schedules, NAC contracts and OM and provide competition when competition is available.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Frank Austan Date Respiratory Therapist Supervisor

04/09/2019

OFOC SOP Revision 08 Page 3 of 3

Revision 08 Date: 04/18/2018

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Ronald J. Kline Date Contracting Officer NCO 4

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Darlene Seminko Date Branch Chief NCO 4

4-9-19 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx