P03 SSJ MPT-SAT - Beutner Labs v2 9-14-20.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-20-AP-2428

Contracting Activity:

Department of Veterans Affairs VA Connecticut Healthcare System 950 Campbell Avenue West Haven CT 06516

2237: 523-21-1-2765-0006

1. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The services requested are consultative services for select surgical pathology cases (auto-immune skin diseases). This would include the associated technical and professional services needed to complete the consultation.

Estimate $22,000 per year; $110,000 total for a 5 year BPA

2. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The reason we must continue to stay with Beutner Labs is for patient safety. The White River Junction and Manchester VA Pathologists and Dermatologists have been using Beutner Labs for Immunofluorescent studies and consultation required to complete diagnostic pathology studies for patients with autoimmune skin diseases for over seven years, and this has resulted in high quality, consistent and efficient treatment of Veterans with auto immune skin conditions.

When VISN 1 first began using Beutner Labs they were the only laboratory that offered these services within a 5-day turnaround time allowing timely completion of pathology reports so that patients can be informed about their diagnosis and begin treatment immediately. There are now other specialized laboratories that offer these services, however, for both diagnosis and following patients who already have a diagnosis (surveillance for therapeutic effect), switching to a different laboratory who may perform the tests differently would potentially alter a patient’s therapy. It would be a similar story asking those who have an established relationship with another specialized laboratory for the same services to switch to Beutner. The considerations would be the same.

This testing and consultative service is highly specialized. It is of the utmost importance that we maintain quality in the pathology reports rendered using the immunofluorescent studies results and interpretations that the pathologists have confidence in and use to make their final diagnosis, and the results the Dermatologists use to determine the appropriate course of treatment for the patient.

https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Page 2 of 3

Revision 01 Eff Date: 04/23/2018

The patient’s well-being as well as the pathologist’s and dermatologist’s licenses are on the line if an incorrect diagnosis is made or incorrect treatment plan is recommended.

Since the staining and interpretation of the immunofluorescent patterns is done by the performing laboratory, our pathologists would have no way to compare the two laboratories without putting the patient at risk by just taking a chance with the results received, rendering a diagnosis and treatment plan based on the new results received, and seeing how well the patient fares. It would be unethical to put our patients at risk like this unnecessarily.

For these studies a separate (second) biopsy is taken from the patient specifically to do these studies. Beutner is designed to handle these specimens and has dermatopathologists on staff who are familiar with the clinical information and can correlate the findings. Therapy for individual patients is guided by the immunofluorescent results for prompt and accurate reporting which directly effects the patient. Beutner labs interpretive skills have earned a great deal of respect and trust from the VA dermatologists and they have provided an open communication for consultation questions and concerns. Beutner’s response to inquiries is excellent, as is rapid access to the dermatopathologists on the Beutner’s staff for consultation and interpretation questions which is vital to the effective and immediate treatment of Veterans. We do not want to cause harm to our patients, delay care, or force patients to undergo additional biopsies that could be avoided if we don’t disrupt the process that is in place currently.

This is the primary reason that the Beutner labs are the only option for this service. The goal is to expedite appropriate treatment for our Veterans and address these rare auto-immune cases as soon as possible.

3. Description of market research conducted and results or statement why it was not conducted:

The service (VISN Laboratory) has tried sending to the local affiliate and found the turnaround time (TAT) extensive since the affiliate actually sent samples to Beutner, and that added confusion and delay to the TAT for results getting back to White River Junction and Manchester VAMC pathologists. The TAT from Beutner is superior to what we can get locally. Beutner can provide this service quickly and effectively for the treatment of auto-immune skin diseases.

Immunofluorescent studies for bullous, autoimmune disorders in the skin require specialized testing, for example salt split, monkey skin etc., and interpretation. These services are not available through non-specialized reference laboratories such as VISN 1’s primary reference lab, Quest. Beutner laboratories provide both with a TAT that meets our requirement for timely Veteran treatment and are known for the quality of their work.

4. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466

VHAPM Part 813.106 Page 3 of 3

Revision 01 Eff Date: 04/23/2018

Name : Thomas Neubelt Date: 9-14-2020

Title: Contracting Officer