36C24419Q0979-003.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-19-AP-3669

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Lebanon VA Medical Center, 1700 S. Lincoln Ave., Lebanon, PA 17042. 2237# 595-19-3-480-0120

2. Nature and/or Description of the Action Being Processed:

This is a new request for the Covidean superDimension ENB system which provides electromagnetic guidance and a steerable guide catheter to access difficult airways in the lung. Estimated cost of this procurement action is .

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

Brand Name Justification for the superDimension ENB system. The superDimension ENB system provides electromagnetic guidance and a steerable guide catheter to access difficult airways in the lung. By extending the reach of the video bronchoscopy, Physicians can access peripheral areas of the lung. The superDimension ENB system also provides guided lymph node aspiration for staging lung cancer patient. In addition to taking biopsies of lesions and lymph nodes, the superDimension ENB system can be used to place fiducial markers for guiding radiation treatment, place markers to facilitate minimally invasive lung surgery, like VATS and guide high dose radiation catheters. There are over 31+ published clinical studies to date reporting the safety (<5% pneumothorax rate, efficacy (74-86% diagnostic yields) and the other uses of the superDimension system.

Acquiring the ENB system will allow the Lebanon VA Medical Center to simplify the process where pulmonary service will be able to perform peripheral lung biopsy on patients that can’t undergo a CT-guided needle biopsy because of risk of pneumothorax or undergo a wedge resection because the patient is a poor surgical candidate. By performing a bronchoscopic Mediastinal Lymph Node biopsy with the superDimension ENB system, it will significantly reduce the need for patients to undergo a Mediastinoscopy, surgical Lymph Node biopsy. By having the superDimension ENB system, it will allow us to biopsy and stage lung cancer in a one procedure and with minimal risk to the patient.

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;

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

The superDimension ENB system is the only system that provides a steerable catheter that works with our video bronchoscope allowing access to 17+ generations of lung. The superDimension system must be used with the superDimension Locatable Guide Procedure Kit or the Edge Procedure Kits. This is required to maximize access to all areas of the lung.

The current VA bronchoscopic procedures can access only 1/3rd of the lung and almost 70% of lung lesions are in the outer 2/3rds of the lung.

Additionally, our patients need an alternative to CT-guided needle biopsy or a surgical wedge resection for lung biopsy. Many of the VA patients at risk for Lung Cancer can’t undergo either a CT guided needle biopsy or a surgical wedge resection because they are at too high of a risk for either iatrogenic pneumothorax or complications associated with surgery. CT-guided needle biopsy is also limited in the size of lesion that it can access.

According to clinical information, Fleischner criteria, a nodule as small as 7-8m mm is the threshold for lung cancer. Motion in the lung makes CT-guided biopsy difficult for small lesions. The location of the nodule and patient anatomy can also make access via CT guided needle biopsy difficult. Nodules that have the scapula on both sides, directly under the ribs or very close to major vessels are unapproachable transthoracically. Mediastinal disease and lesions close to central airways are much better approached by bronchoscopic approach, and may not be approachable at all transthoracically. A CT-guided needle biopsy can’t stage the mediastinum or evaluate for occult airway abnormalities so this approach relegates the patient to at least 2 procedures when a bronchoscopic approach could evaluate issue in one procedure. VA patients need an alternative to watchful waiting. Many VA patients are at risk for pneumothorax with CT guided needle biopsy or for having major complications with a surgical biopsy, they are placed in watchful waiting which gives the malignancy time to advance. Treatment options in advance disease have poor prognosis and increased expense.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Contacted the manufacturer for a list of distributors/resellers. Manufacturer stated that they only offer this equipment through three SDVOSB distributors.

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

The cost will be determined to be fair and reasonable based upon the expected competition among the distributors. Prices can also be compared to past purchase of similar systems and the IGCE which was developed using informal market research from the manufacturer.

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

Research was performed of other VA system including but not limited to; Omaha VA, Milwaukee VA, Ann Arbor VA, Birmingham VA, Edward Hines VA, Palo Alto VA, Reno VA, Denver, and Tucson VA. superDimension ENB systems are placed in dozens of VA’s across the country. In researching technology’s that provide minimally invasive methods to diagnosis peripheral lung lesions with a diagnostic yield higher than TTNA procedures, we found that no other system provides a platform with a steerable tool/catheter that reaches all the way to the pleura. This supports the justification the VA used to procure the equipment. They needed a better way to diagnose their patients in a less invasive way because their patients were recovering so poorly with the current lung biopsy techniques, surgery or transthoracic needle biopsy. The superDimension ENB was the only option for these patients to receive a diagnosis and still move onto a less invasive treatment, such as radiation therapy.

We also researched the published clinical data on superDimension. This is the only minimally invasive, bronchoscopic approach for lung biopsy that has multiple publications on the results (31+) and 80%+ diagnostic yields reproducible across multiple sites. Compare to the traditional bronchoscopic biopsy, without ENB, which has <20% diagnostic yields.

Examples of ENB with Diagnostic yields >80%.

Improved Diagnostic Yield of Bronchoscopy in a Community Practice: Combination of Electromagnetic Navigation System and Rapid On-site Evaluation, David S. Wilson, MD and Rebecca J. Bartlett, RN, BSN, J Bronchol, Volume 14, Number 4, October 2007

Electromagnetic Navigation Bronchoscopy Performed by Thoracic Surgeons: One Center’s Early Success, Daryl Phillip Pearlstein, MD, Curtis Quinn, MD, Annals of Thoracic Surgery, The Efficacy of Electromagnetic Navigation Bronchoscopy Using a New Software System for Patients with Indeterminate Pulmonary Nodules, presented at Society of Thoracic Surgeon’s Meeting, January 30, 2012, submitted for review to Annals of Thoracic Surgery.

It also offers a formal training of hands on education for the physician and staff. The company also provides onsite support for procedures.

The superDimension i-Logic system has proven substantial clinical benefits and financial savings to the VA system. Some of the key points that have support this sole source:

Improved Patient Care:

1. Avoided pneumothorax from TTNA

2. Decreased number of multiple attempted bronchoscopies from failed attempts to get diagnosis

3. Averted non-therapeutic thoractotomies.

5. Move patients from watchful waiting and give them a definitive diagnosis showing that on the day of the procedure.

Increased Cost Savings (reflecting Mayo Clinic data):

1. Cost of TTNA (Transthoracic Needle Aspiration/CT-Guided Needle Biopsy):

2. Cost of Open Surgery for Diagnosis: Thoractotomy, VATS (Video Assisted Thoracoscopic

Surgery), Wedge Resection, Mediastinoscopy:

3. Cost of Watchful Waiting:

4. Cost of superDimension procedure:

Safe and Accurate Peripheral Access leads to Multiple Applications:

1. Placement of fiducial markers prior to stereotactic radiosurgery, to accurately localize and track motion of lung tumor during therapy. A much safer and easier alternative to fiducials placed via TTNA.

2. Other applications include:

1. Tattooing of lesion and pleura prior to surgery for purposes of lung sparing and decreased VATS to thoractotomy conversion rate.

2. HDR wire placement for brachytherapy

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

The Covidien superDimensions ENB system uses which is proprietary to the manufacturer.

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:

At this time no actions are available to overcome the competition barrier due to the proprietary nature of the technology. Market Research will be conducted in the future to see if other manufacturers will be able to offer a system with similar functionality or have developed a better technology which would be of interest to the VA.

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.

Christopher Small Business Manager Lebanon VAMC

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Christopher L Small 358742

Digitally signed by Christopher L Small 358742 Date: 2019.07.31 08:21:13 -04'00'

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.

William MacDougall Contracting Officer NCO 4, Commodities 1

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.

Caroline L. Robinette

Acting Branch Chief, NCO4

William D MacDougall 350614

Digitally signed by William D MacDougall 350614 Date: 2019.07.31 08:24:33 -04'00'