JA_VISN 15 Scopes.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11 Page 1 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C255-21-AP-1510

1. Contracting Activity:

Network 15 Contracting Office (NCO 15) Veterans Integrated Service Network 15 3450 W. 4th Street Kansas City Medical Center Leavenworth, KS 66048 4801 Linwood Blvd.

Kansas City, MO 64128

2. Nature and/or Description of the Action Being Processed This is a new requirement for Veterans Integrated Service Network (VISN) 15, to lease Endoscopes (Gastrointestinal (GI), Urology, Ear Nose and Throat (ENT), etc..) endoscope equipment, and provide maintenance on the Endoscopes and equipment. Endoscope procedures enables a wide array of procedures to be performed to diagnose and treat acute, malignant, or chronic situations within Endoscope, Urology, and specialties.

This will be a firm-fixed price, Indefinite Delivery, Indefinite Quantity (IDIQ) contract servicing all VISN 15 Medical Centers and Clinics. This is not a requirements contract. It will have a base year and three (3) one-year option periods.

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

Base + 3 option periods Required start date July 1, 2021 Base: July 1, 2021 – June 31, 2022 Option 1: July 1, 2022 – June 30, 2023 Option 2: July 1, 2023 – June 30, 2024 Option 3: Jul 1, 2024 – June 30, 2025 Base year plus three option years would cover the new GI technology that is coming to market soon and will give the stations full usage over the course of the lease. Base year plus four option years is not recommended, especially for the surgical equipment because of technology advancement. This IDIQ will have option periods so that market research can be conducted to examine competition and find if there is another provider that could provider that could off a better price before the option is exercised.

The need is to lease Endoscopes (GI, Endo, Urology, ENT), endoscope equipment, and provide maintenance on all the items. These scopes and equipment enable the physician to perform a wide array of procedures. With being able to perform these procedures the physician can diagnose and

OFOC SOP Revision 11 Page 2 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021 treat acute, malignant, or chronic conditions. Being able to have these scopes and equipment at the facility prevents the patient from having to travel to another location to have the procedures done, which could be a hardship or cause harm to the patient with the delay.

Maintenance is needed so we can meet our patient safety requirement, no harm to patient, no wait time for patient due to scope not in proper working order. Need for 24 hours turn around for repair, loaner, tracking of repairs, tracking where the scope is, having the manufacturer of the scope doing the repair and not going through a third party. It is required that maintenance of the scopes by done by the manufacturer as only the manufacturer can provide Original Manufacturer Part (OEM) parts and authorized repair.

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 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

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

VISN 15’s requirement to Lease Scopes for the past 9 years has dictated that the VISN 15 facilities have equipment that directly compatible with the brand of Endoscope that were being leased. In this case, the Olympus brand. The associated system is standardized to ensure that the equipment will function correctly, including ancillary equipment and reprocessing equipment. This equipment is extremely sensitive and optimal functionality will be ensured by using Endoscopes that are specifically designed to use with the existing Olympus system. The estimated value to replace the equipment across VISN 15 is estimated $1,800,000.00 which is not the new technology. Accordingly, Olympus is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing a substantial duplication of cost that is not expected to be recovered through competition. We are wanting an all-inclusive contract to ensure we can meet our needs and avoid harm or delay to our patients. In order to provide all inclusive, we are needing to include ENT and Urology scope along with maintenance for all items leased. By having this lease, we are guaranteed to have the latest technology.

The incumbent contract meets, and exceeds, the Government requirement. There have been no issues, education is provided, doctors and staff are very comfortable with the product. If we were to change this would be a major impact to all aspects of the program. There would be addition training cost if staff had to be trained to use a different brand. Also, unfamiliarity with a different brand could pose a risk to patient health.

The following is a list of equipment that would need to be replaced if we were to change manufacturers: Olympus scopes, video processors, and light sources. It could also affect our high definition monitors which could have to be replaced, with that we would be replacing video cabling, needed to add or replace within the booms in every room. Including the trigger and video cable to send images to our dictation system.

Replacement of the scopes will hinder patient care. Our GI may have to curtail services for the following reasons: All previous scopes would need to be accounted for, and turned in to OEM. All incoming new scopes shall be inventoried, inspected and reprocessed in preparation for patient use.

Every procedure room will and may need retro fitting to accommodate video display necessity with

OFOC SOP Revision 11 Page 3 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021 all existing OEM hardware accounted for turn in and return to OEM. Installation of new hardware, testing and training for both clinical and technical.

Olympus has the latest technology including the new 510K technology. 510K provides advanced industry innovations and technological advancements HDTV, Narrow Band Imaging and Response Insertion Technology. Having the most current technology and equipment on hand ensures that patients are seen at VISN 15 facilities versus non-VA locations, where the Government may incur more cost. The new TJF-180 ERCP scope has a disposable end cap and meets FDA recommendations. The FDA has recommended that customers move to a disposable end cap or disposable scope within the next 24 months. No other provider of scopes offers this feature. The new TJF-Q190V will replace the 180 model when the new lease is executed in 2021. The new TJF- Q190V scope comes with 3 years of Premium Protection included in the price (which means full service for all repairs & maintenance is covered).

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

Market Research will be conducted prior to exercising each option period to determine if the market has changed. This Market Research will also be conducted before solicitation of the next contract to evaluate the need for keeping with Olympus scopes. Before the solicitation, for the next contract, a Sources Sought will be conducted to determine if additional companies may provide a lease for Olympus scopes.

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

The Contracting Officer has determined the anticipated cost will be considered fair and reasonable.

The current price list of the current Federal Supply Schedule (FSS) (V797P-2065D) that expires December 30, 2021 was examined to assist in determining the anticipated cost to be fair and reasonable. A contract from VISN 8, 36C24821C0005, was also used to compare pricing.

As this is a commercial item being acquired, certified cost or pricing data is not required.

Technical evaluation will be conducted by a panel of medical staff that routinely use this equipment.

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

IAW VAAR 808.002 Veterans First Contracting Program, there were not two or more SDVOSB or VOSB vendors that could be identified to meet these requirements.

FPDS Search using Keywords “Scopes Endoscopic, ENT scopes, and Urology scopes”.

o Identified 12 awards to Olympus, a large business.

VETBIZ Search Identified 45 SDVOSB/VOSB under NAICS Code 532490. Adding keywords “Endoscope Lease” showed 41 vendors and “Medical Equipment Lease” three showing vendors. After review none of these vendors can meet our needs.

SBA Search Identified 3,012 vendors under NAICS Code 532490. Adding keyword “Endoscope Lease”, Medical Equipment Lease, ENT Lease, and Urology Lease.

OFOC SOP Revision 11 Page 4 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Showed zero results that can meet all these needs.

Sources Sought were posted to GSA and beta.sam.gov 3/15/2021 through 3/22/2021. There were no responses to the GSA Sources Sought. There were three responses to the beta.sam.gov Sources Sought. L1 does not provide Olympus scopes. Karl Storz only provides Karl Storz scopes. Olympus fills the requirements.

A waiver to the Buy American statue has been signed. The two major manufacturers of scopes were found to be Karl Storz and Olympus. The majority of Karl Storz scopes are manufactured in Germany. Olympus scopes are manufactured in Germany and Japan. Postmaster General, B156082 (May 1, 1967) confirms this applies to leased equipment as well.

Olympus was contacted and it was found that only Olympus can provide OEM parts and provide certified maintenance.

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

N/A

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

Sources Sought were posted to GSA and beta.sam.gov 3/15/2021 through 3/22/2021.

There were no responses to the GSA Sources Sought. There were three responses (see below) to the beta.sam.gov Sources Sought. L1 does not provide Olympus scopes, only Karl Storz scopes. Karl Storz only provides rigid scopes and no ENT scopes.

L1 Enterprises, Inc.

618 W. Patrick Street Frederick, MD 21701

Karl Storz 2151 E. Grand Ave.

El Segundo, CA 90245

Olympus America, Inc.

3500 Corporate Parkway Center Valley, PA 18043

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:

Based on the needs of VISN 15, continual market research will be conducted to determine new players in the market to lease Olympus or compatible scopes.

OFOC SOP Revision 11

Original Date: 03/22/11 Revision 11 Date: 02/11/2021

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.

Lynda Frey Date Supervisor Supply Management Specialist

VISN 15

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

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.

Date

Paul Hemenway Supervisory Contract Specialist Branch Chief – Supply Team B Network Contracting Office (NCO15)

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Date

Network Contracting Office (NCO15)

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Date

Terry L. Spitzmiller

PAUL

HEMENWAY

Digitally signed by

PAUL HEMENWAY

Date: 2021.05.17 14:33:23 -05'00'

Lynda S. Frey 169632

Digitally signed by Lynda S.

Frey 169632 Date: 2021.05.19 10:53:00 -05'00'

LOYD

JACKSON

Digitally signed by LOYD

JACKSON

Date: 2021.06.07 07:50:06 -05'00'

06/29/2021

TERRY

SPITZMILLER

Digitally signed by

TERRY SPITZMILLER

Date: 2021.06.29 07:55:59 -05'00'