P03 Urgent Pittsburgh FAR 8 LSJ WCS ALS Signed.pdf

36C244-25-AP-0539 | Urgent Pittsburgh

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ)

For Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C244-25-AP-0539

2237 PR# 646-25-1-084-0057

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Pittsburgh VA Medical Center, University

Drive C, Pittsburgh, PA 15215.

2. Nature and/or Description of the Action Being Processed: This activity proposes to contract with LabCorp using sole source procurement procedures to procure an Autoimmune encephalopathy profile on CSF, Autoimmune encephalopathy profile on serum, Paraneoplastic, Autoantibody Profile on CSF, and Paraneoplastic Profile on serum . The performance of these tests identifies encephalopathies of unknown origin with acute onset of seizures, confusion, memory loss, and behavioral changes and paraneoplastic syndromes. Specimens are only viable for 14 days it is critical for this testing to be done for a definitive diagnosis and to provide excellent patient care.

FSS Contract Number: V797D-50532 LabCorp 5500 Corporate Drive STE 226 Pittsburgh, PA 15237 412-364-4364

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Pittsburgh VA is requesting the purchases of Autoimmune encephalopathy profile on CSF, Autoimmune encephalopathy profile on serum, Paraneoplastic, Autoantibody Profile on CSF , and Paraneoplastic, Autoantibody Profile on serum. This testing will be used for an aid in diagnosing encephalopathies and paraneoplastic syndromes of unknown origins.

The following elements are required:

Estimated Amount of Award: $125,868.85 Period of Performance: 11/08/2024 – 11/07/2025 (Order as Needed)

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies;

and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

Item # Description Part Number*

Qty

505625

Autoimmune encephalopathy profile, CSF 5

505535 Autoimmune encephalopathy profile, serum 5

505700 Paraneoplastic, autoantibody panel on CSF 5

505575 Paraneoplastic, autoantibody panel on serum 5

36C244-25-AP-0539 | Urgent Pittsburgh

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; (FAR 8.405- 6(a)(1)(i)(B)); The supplier of the current send out Laboratory testing contract holds a service contract agreement for the next year and review of Mayo clinic and ARUP autoimmune encephalopathy profile testing on CSF fluid reveals additional reflex testing that are not required if the test should require reflexing.

No other vendor or authorized distributor are available for this test that performs the following specific reflex testing Anti- Hu Ab, Anti-Ri Ab, Antineuronal nuclear Ab type 3, PCA Type 1 (Anti-Yo Ab), Purkinje cell cyto Ab type 2, Purkinje cell cyto Ab type Tr, Amphiphysin Ab, CRMP-5 IgG, AGNA- 1, DPPX Ab, mGluR1 Ab, IgLON5 Ab, Ma2/Ta Ab, Zic4 Ab, DNER Ab, ITPR1 Ab, AMPA-R-1 cell based IFA, AMPA-R-2 cell based IFA, GABA-B receptor cell based IFA, NMDAR cell based IFA, GAD65 Ab cell based IFA, CASPR2 Ab cell based IFA, and LGI1 Ab cell based IFA.

5. Rationale/explanation to support cited authority:

VAPHS would require a new contract with a send out laboratory to perform specialized testing with purchasing a new contract that would requiring allocating additional funding. An additional send out contract with the same send out testing would require expert educated staffing in this laboratory to perform this testing. The supplier of the current send out testing contract holds a service contract agreement for the next year and review of Mayo clinic and ARUP autoimmune encephalopathy profile testing on CSF and serum fluid reveals additional reflex testing that are not required if the test should require reflexing.

It is in our best interest that we use LabCorp for this testing to reduce the amount of time acquiring an additional send out contract, allocating funding to supply this contract, and finding an expert staff in this send out test laboratory to perform highly complex testing.

The supplier of the current send out testing contract holds a service contract agreement for the next year and review of Mayo clinic and Cleveland Clinic Paraneoplastic, Autoantibody Profile testing on CSF and serum reveals additional routine laboratory testing such as a complete blood count, urinalysis, and serum electrophoresis that have already been performed at the VA Pittsburgh Health System where the Veteran is a patient. The review of Mayo clinic and Cleveland Clinic Paraneoplastic, Autoantibody Profiles on CSF would also result in reflex testing that is not needed if the test were to reflex. It is in our best interest that we use LabCorp for this testing to reduce the amount of time acquiring an additional send out contract, allocating funding to supply this contract, and finding an expert staff in this send out test laboratory to perform highly complex testing.

6. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Amanda Saunders Lead Contracting Officer NCO4, Services 5

William C Schlobohm Contracting Officer NCO4, Branch Chief – Services 5

WILLIAM

SCHLOBOHM

Digitally signed by WILLIAM

SCHLOBOHM

Date: 2024.11.07 12:59:39 -05'00'

AMANDA

SAUNDERS

Digitally signed by AMANDA

SAUNDERS

Date: 2024.11.07 13:44:33 -05'00'