P03 Haag Streit Brand Name Justification Signed.pdf

MEMORANDUM TO THE FILE

Subj: JUSTIFICATION FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

FOR AN ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

1. Organization/Line Office:

Department of Veterans Affairs, VISN 22, Long Beach 600 Medical Center VA Long Beach

600. PR 664-20-3-072-0151.

2. Description of Action being approved:

The VA San Diego currently has a need for the following products:

The Ophthalmology Clinic requires a Haag Streit Slit Lamp Imaging System to be installed on an existing Haag Streit BQ-900 Slit Lamp located in the clinic. The imaging system would need to fully be integrated on the existing slit lamp. The imaging system should have several features due to our complex patient population that would allow quick and efficient image capture as many of our patients has cognitive and physical conditions that do not allow them to sit still in the slit lamp. The slit lamp also needs features to allow for high quality image capture suitable for research, teaching and publication. To meet these requirements the system should include a history trigger that allows capture at least 30 images on a single exposure, an integrated control within finger length of the existing Haag Streit slit lamp joystick, an adjustable aperture setting and a depth of focus control. The imaging system provides this information to the EyeSuite software. The imaging system and Eyesuite software needs to interface with the VA’s existing network and it will also contain patient’s private information. In accordance with Directive 6550, any time a software has access or contains patient’s private information, it shall be approved by the VA Office of Information and Technology (OIT), the Haag Streit Eyesuite Imaging Software is an approved software by the VA OIT.

Furthermore, the ophthalmology department needs a separate Haag Streit slit lamp with tonometer mounted on a motorized height adjustable slit lamp table. The new slit lamp needs to be compatible with existing Haag Streit attachment and accessories. The new slit lamp needs to be compatible for use of a Haag Streit Stereo Variator and a Haag Streit Inclined Optics. As a tertiary referral center for complex ophthalmic conditions, the VA San Diego clinic has a high number of complex patients with unique conditions that require a stereo variator in order to provide optimal viewing conditions through the slit lamp. Also, due to ergonomic needs of some of our doctors, we require compatibility with a Haag Streit Inclined Optics. Due to the nature of these complex conditions in the patients, the VA San Diego Healthcare System requires a star fixation system on the slit lamp. This will assist the doctors in better visualizing the retina.

3. Description of Product, Supplies or Services:

The imaging system would be an upgrade to an existing Haag Streit BQ-900 slit lamp. The existing tungsten bulb would need to be upgraded to an LED Bulb. The vendor would need to perform the installation and training. The slit lamp would be a new Haag Streit BQ-900 slit lamp with tonometer mounted on a motorized height adjustable slit lamp table.

The items being requested are as follows:

Haag-Streit BQ900 LED Slit Lamp with Motorized Table Haag-Streit BQ900 Tonometer Haag-Streit IM900 Imaging System with camera, computer, Eyesuite software and monitor.

Haag-Streit DICOM License for Eye Suite Haag-Streit Retrofit Kit for BQ900 slit lamp Haag-Streit Eye Suite Software. Software must be VA OIT approved.

Installation Training Warranty to include onsite service calls

4. An identification of the statutory authority permitting other than full and open competition. (Requesting Office completes with assistance of Contract Specialist)

a. FAR 13.I06-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

b. As required by FAR 13.106-3(b)(i), this memorandum explains the limitation of sources for this acquisition, as only one brand name will be solicited for this requirement (or for a portion of the requirement) and the requirement (or portion of the requirement to be sole-sourced) is not expected to exceed the simplified acquisition threshold.

5. Determination for use of other than full and open competition:

(Select all that apply)

A. _ ONLY ONE RESPONSIBLE SOURCE (select a/I that apply):

1. _ RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required.

2. _ EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM.

3. OTHER REASONS.

B. _X_ BRAND NAME

This acquisition is restricted to the following Source: Manufacturer: Haag-Streit is the manufacturer for items required, the BQ900 Slit lamp, BQ900 Tonometer, IM900 Imaging System and the DICOM License for EyeSuite.

Haag-Streit USA, INC.

3535 Kings Mills Road Mason, OH 45040 POC Mitchell Kronenberg Director of Channel Management General Diagnostics Cell 513-476-4348

C. ___ URGENT AND COMPELLING

The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits quotes. Urgent requirements are supplies or services that will result in a work stoppage or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

Justification: The VA San Diego Healthcare System already has 12 Haag Streit BQ-900 Slit Lamps and attachments and accessories. The slit lamp for the emergency room needs to be fully compatible with existing equipment. Specifically, the slit lamp needs to be compatible with a Haag Streit Stereo Variator and Haag Streit inclined optics. Haag Streit is the Original Equipment Manufacturer. Haag Streit provided a licensing rights letter confirming that only Haag Streit slit lamps are compatible with a Haag Streit stereo variator and Haag Streit inclined optics. Also, the Haag Streit is the only slit lamp with the required star fixation system which assists the doctors better visualizing the retina specially when examining complex conditions on the patients. If a brand other than Haag Streit were to be purchased it would not be compatible with the VA San Diego existing equipment and attachments, it will cost the Government an additional estimated amount of $12,000 to buy additional accessories. Furthermore, the software will also have compatible with the Haag Streit equipment already in place at the VA San Diego, and this software contains and provides patient’s private information. A different brand of software will not work with any Haag Streit products. In accordance with Directive 6550, software that contains and provides patient’s private information and it has access to the VA servers must be VA OIT approved. The Haag Streit software is VA OIT approved per Directive 6550. A different brand of software will have to be approved by the VA Office of Information and Technology. Last, the Government would not be efficient in taking care of the veterans because a considerable amount of the doctors’ time as accessories and attachments could not be swapped from the emergency room slit lamp to the existing Haag Streit slit lamps in the Ophthalmology Clinic in a timely manner. The VA San Diego staff is trained in the use of Haag-Streit slit lamps, if a brand other than Haag Streit were to be purchased it will cost the Government an additional funding in training on new equipment.

Many features of the slit lamp capture system and software, as listed above, are only available on Haag Streit systems and are critical and essential to meet the VA’s mission of serving the veterans. Haag Streit provided a licensing rights letter on 06/26/2020.

6. Certifications

As the technical or requirement personnel, I certify that the evidence of the supporting data that forms the basis of this justification is complete and accurate.

X

Dr. John Monroe_________________________ Physician

Contracting Officer