Notice of Intent to Sole Source Athena Neurological Testing

?.## STATEMENT OF WORK
STATEMENT OF WORK
Reference Lab for Genetic Testing for Neurologic Disorders
For the Department of Veterans Affairs
Portland VA Medical Center
3710 S.W. US Veterans Hospital Road
Portland, OR 97239-2964
1. Background
The Portland VA Medical Center (VAMC) requires reference lab services to conduct genetic testing for neurologic disorders (Alzheimer s disease, muscular dystrophy, and other neuromuscular and developmental disorders). These tests provide diagnostic services for neurology, endocrinology, nephrology, hearing loss, charcot-marie-tooth disease, and wholegenome microarrays, and also offers diagnosis in the areas of peripheral nerve disorders, neurogenetic disorders, Alzheimer's disease, paraneoplastic syndromes, movement disorders, neuromuscular disorders, and ataxia.
2. Scope
All work is to be performed at the reference laboratory for lab tests requested by the Portland VAMC, Pathology and Laboratory Medicine (PLMS) Department. The period of performance for this service contract is a base period plus 4 option years.
3. Specific Tasks
The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing to identify neurologic disorders. Quantities of tests will depend upon patient specifics. (See table listing specific tests)
Description
Test #
DIRECT MUTATION SCA-3
105
RIAUTOANTIBODY TEST
115
CAR AUTOANTIBODY TEST
118
FRIEDREICH'S ATAXIA
119
NEURONAL NUCLEAR (Hu) AB
120
CLCN1DNA SEQUENCING TEST
128
PMP22 UPLICATION/DELTION DNA TEST
131
MYOTONIA EVALUATION
147
TAU/AB42
177
SULFATIDE AUTOANTIBODY
210
PMP-22 DNA SEQUENCING
247
SENSORY NEUROPATHY PROFILE-XP
263
Co-GM1TRI.AD AUTOANTIBODY
277
MOTOR NEUROPATHY PROFILE- COMPLETE
288
PARANEOPLASTIC PROFILE, BASIC
365
DIRECT MUTATION SCA-1
371
DIRECT MUTATION SCA-6
373
DIRECT MUTATION SCA-8
384
DIRECT MUTATION SCA-10
387
DIRECT MUTATION SCA-17
388
DPRLA DNA TEST
401
FSHD DNA
405
CMT DOMINANT EVALUATION, PARTIAL
414
NMDA RECEPTOR ANTIBODY TEST
419
CADASIL DNA TEST, COMPLETE
421
AMPHIPHYSIN ANTIBODY
427
PARANEOPLASTIC NEOSENSORY NEUROPATHY
436
NEOCOMPLETE PARANEOPLASTIC PROFILE
437
PARANEOPLASTIC CEREBELLAR DEGENERATION
438
PARANEOPLASTIC ENCEPHAUTIS PROFILE
439
LEMS AUTOANTIBODY TEST
475
DYSFERLIN, BLOOD
561
CALPAIN 3 DNA SEQUENCING
563
DIRECT MUTATION SCA-14
593
DYSTONIA
626
SPASTIC PARA EVAL
650
DIRECT MUTATION SCA-2
672
DIRECT MUTATION SCA-7
677
ATAXIA PANEL Autosomal Dominant
680
PKDX SEQUENCING
725
VON HIPPEL-LINDAU SYNDROME
858
The contractor will report reference lab testing results to PVAMC PLMS via secure fax to 503-402-2901.
4. Performance Monitoring
The tasks are well defined and can, therefore, be easily monitored by the Government point of contact (POC), who shall represent the government for this process. The contractor performance will be monitored and the work certified by the POC. The reference lab is required to obtain regulatory accreditation. therefore, lab testing quality assurance is monitored by an independent third party. The reference lab will provide proof of current accreditation upon request.
5. Security Requirements
The contractor must have and maintain accreditation as a healthcare provider to include compliance with the Health Insurance Portability and Accountability Act (HIPPA) of 1996 to ensure all Personal Health Information (PHI) is safeguarded from unauthorized disclosure. All test results will be sent to PVAMC PLMS via secure FAX.
6. Inspection and Acceptance Criteria.
The POC is responsible for certifying that the work done under this contract is performed to standard. The POC is also responsible to assure the inspection and acceptance of products provided incidental to services.
7. Place of Performance.
All work shall be performed at the contracted reference lab.
Other locations for the NCO20 catchment area may be added to the contract via bilateral modification after award.
8. Business Hours / Days:
Are defined as the time of 8:00AM to 5:00PM, Monday through Friday, excluding Federal holidays: Â
New Year's Day January 1 *
Martin Luther King's Day Third Monday in January
President's Day Third Monday in February
Memorial Day Last Monday in May
Independence Day July 4*
Labor Day First Monday in September
Columbus Day Second Monday in October
Veteran's Day November 11
Thanksgiving Day Fourth Thursday in November
Christmas Day December 25*
*If the date falls on a Saturday, the Government holiday is the preceding Friday. If the date falls on a Sunday, the Government holiday is the following Monday.
In addition to the designated holidays, the Government observes the following days:
Any other day designated by Federal Statute
Any other day designated by Executive Order
Any other day designated by the President's Proclamation
Off Business Hours/Days are defined as the time of 5:01PM to 7:59AM, Monday through Friday, all day Saturday, Sunday and Federal holidays.
9. Period of Performance.
Contract will be one base period plus four option years.
Base Period: Date of Award 11/30/2019
Option One: 12/1/2019 11/30/2020
Option Two: 12/1/2020 11/30/2021
Option Three: 12/1/2021 11/30/2022
Option Four: 12/1/2022 11/30/2023
10. Point of Contact.:
Point of Contact (POC): The POC is the Biomedical Engineering Department designee. The POC for the contract is:
Suzanne Denker
Portland VA Medical Center
Pathology and Laboratory Medicine
3710 S.W. US Veterans Hospital Road
Portland, OR 97239-2964
(503) 220-8262 x56776
Suzanne.Denker@VA.Gov
The POC is NOT a Contracting Officer Representative (COR), although the POC may certify invoices.
11. Delivery Schedule.
SOW Task#
Deliverable Title
Format
Number
Calendar Days After CO Start
1
Test Results
Contractor determined lab test results report
1 Faxed copy
Within days published in reference lab catalog..