Q301--Comprehensive Ataxia Evaluation Testing EMERGENCY

INTENT TO SOLE SOURCE

The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a contract for Alport Syndrome Testing Services for the Pittsburgh VA Medical Center. All work is to be completed in accordance with statement of work. This sole source contract will be solicited and negotiated with Athena Diagnostics, INC, 377 Plantation St., Worcester MA 01605 under the authority of FAR 13.106-1 Single Source Justification.

See attached Draft Statement of Work (SOW).

The North American Industry Classification System (NAICS) code for this procurement is 621511. The Small Business Administration (SBA) size standard is $41.5.

Interested vendors that can meet this requirement, shall identify their interest and capability, and respond to this notice by 07/31/2023 by 10:00 AM EST. Interested vendors must send a capability statement, no more than one page in length; to include Company Name, ueiSAM Number, Socioeconomic Category, brief description of your business entities capability to handle this project at the Pittsburgh VA Medical Center.

This Special Notice of Intent to Sole Source is for planning purposes only. No solicitation will be made available. This is not a request for quotations. All information shall be provided at no cost or obligation to the Government. Responses must be sent via email to the Contracting Specialist at christa.stine@va.gov.

Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon the responses to this notice is solely at the discretion of the Government. If no responses are received, Contracting will proceed with the sole source negotiation with Athena Diagnostics, LLC.

DRAFT

Statement of Need

Pittsburgh VA Medical Center

AP-4274STATEMENT OF WORK (SOW)

Esoteric testing for Ataxia comprehensive evaluation

as of 7/12/23

P

1. Contracting Officer s Representative (COR).

Name:

Cathy Noble

Section:

Pathology Medicine

Address:

University Drive

Pittsburgh, PA 15240

Phone Number:

Ph# 412-360-1524

Fax Number:

Fax# 412-360-6922

E-Mail Address:

Cathy.Noble@va.gov

2. Contract Title. Ataxia. Comprehensive Evaluation         Â

3. Background.

Hereditary ataxias are a heterogeneous group of disorders phenotypically characterized by gait ataxia, incoordination of eye movements, speech, and hand movements, and usually associated with the atrophy of the cerebellum. Ataxias usually result from damage to the part of the brain that controls muscle coordination or its connections. The classification of hereditary ataxias is based on the pattern of inheritance or mode of genetic transmission of the disorder which can be autosomal dominant, autosomal recessive, or X-linked. Treatment for ataxia depends on the cause.

The Ataxia comprehensive evaluation test identifies mutations and repeat expansions associated with all types of hereditary ataxias. The test is useful for suspected hereditary ataxia with unavailable or inconclusive family history. The test uses next generation sequencing, repeat expansion detection by polymerase chain reaction, dosage analysis, and western blot. This test includes 11 repeat expansion tests, 33 genes sequenced, and ATM deletion test that identifies mutations and repeat expansion associated with all types of hereditary ataxias.

4. Scope.

This contract includes all the costs associated with performing the Ataxia comprehensive evaluation that is performed at Athena Diagnostics. In addition, the contract includes pricing for performing the testing and any reflex testing that is associated with the Ataxia comprehensive evaluation.

This contract is specifically for the use of the Pittsburgh VA Medical Center Laboratory send out section only.

5. Specific Tasks.

This contract is required to provide pricing for all necessary consumables required to perform the Ataxia comprehensive evaluation test including quality control materials. In addition, the contract will include pricing for required reflex testing to identify hereditary ataxias. These items will be permitted to be ordered as needed by the Pittsburgh VA.

Task 2 Test Configurations

Deliverables: The following routine Ataxia comprehensive evaluation and any reflex testing are ordered as needed.

The following table is the Ataxia Comprehensive evaluation and all the expansion tests included in the panel and the ATM deletion test that identifies mutations.

Item #

Description

Qty

6930

Ataxia with Vitamin E Deficiency (AVED) TTPA DNA Sequencing Test

1

DRPLA (ATN1) Repeat Expansion Test

1

Friedreich Ataxia (FXN) DNA Sequencing Test

1

Friedreich Ataxia (FXN) Repeat Expansion Test

1

SCA1 (ATXN1) Repeat Expansion Test

1

SCA10 (ATXN10) Repeat Expansion Test

1

SCA12 (PPP2R2B) Repeat Expansion Test

1

SCA17 (TBP) Repeat Expansion Test

1

SCA2 (ATXN2) Repeat Expansion Test

1

SCA3 (MJD/ATXN3) Repeat Expansion Test

1

SCA6 (CACNA1A) Repeat Expansion Test

1

SCA7 (ATXN7) Repeat Expansion Test

1

SCA8 (ATXN8OS) Repeat Expansion Test

1

The Ataxia comprehensive evaluation will also include testing for the following genes:

ADCK3, AFG3L2, ANO10, APTX, ATM, ATN1, ATXN1, ATXN10, ATXN2, ATXN3, ATXN7, ATXN8OS, CACNA1A, CACNB4, EEF2, FGF14, FLVCR1, FXN, GRM1, ITPR1, KCNA1, KCNC3, KCND3, MRE11A, MTPAP, PDYN, POLG, PPP2R2B, PRKCG, SACS, SETX, SIL1, SLC1A3, SPTBN2, SYNE1, SYT14, TBP, TDP1, TGM6, TTBK2, TTPA, VAMP1.

6. Performance Monitoring

It will be the responsibility of the Pittsburgh VA Medical center send out testing Supervisor/designee to monitor all performance issues with the vendor. Timely delivery of testing results compared to the terms of the contract.

7. Security Requirements

In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information is faxed to the VA Pittsburgh when results are completed.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No GFE or GFI will be needed in any capacity.

9. Other Pertinent Information or Special Considerations.

The send out testing will include all tests listed in the Ataxia comprehensive evaluation.

Test results will be delivered in a timely manner.

All testing that was not able to be performed will be communicated to supervisor/designee.

10. Period of Performance

This is a one-time purchase of an Ataxia comprehensive evaluation.

11. Delivery Schedule.

All required items will be ordered as needed directly by the lab and delivered within one 21-28 days.

All testing results will be delivered to:

Attn: Hope Demosky

VA Pittsburgh Healthcare System

University Drive

Pittsburgh, PA 15240

Fax: 412-360-6922

The send out testing supervisor/designee are the designated individuals able to place orders against this contract.