Q301--Cytopathology and ThyroSeq Testing

STATEMENT OF WORK

Cytopathology and ThyroSeq Testing

Introduction

Lebanon VA Medical Center Pathology and Laboratory Medicine Services Department is in need to acquire Cytopathology Fine Needle Aspiration (FNA) and ThyroSeq molecular testing of thyroid nodules. The ThyroSeq test is intended for genomic profile to improve detection of malignancies in indeterminate cases, identify molecular signature of more aggressive cancers and to give insight into therapeutic efficacy based on the molecular profile. These molecular tests of an indeterminate thyroid nodule can stratify patients into those who may or may not need a surgical procedure. This testing will be performed at an outside laboratory. An FNA specimen from a thyroid nodule is placed into transport media provided by testing company and shipped to the testing laboratory using their shipping materials. The volume of FNA tests performed annually is estimated at 150. Depending on the result, some of these tests will require additional molecular testing. The volume of molecular tests performed annually may be approximately 30 tests per year and increase each year at the present biopsy rate and present rate of indeterminate nodules.

Contractor shall provide oncology-related laboratory testing services to include: specimen requirements, means of transport for specimens from Lebanon VA laboratory to contractor s laboratory via courier for processing and analysis of the specimen. Consultation regarding selection, collection, transportation and result interpretation shall also be provided when required.

Type of Contract and Delivery

The Lebanon VA Medical Center and Laboratory Medicine Services Department are contracting for a Firm Fixed Priced (FFP) five (5) year Indefinite Delivery Indefinite Quantity (ID-IQ).

IDIQ contract Minimum: ThyroSeq Test 30

Cytopathology 150

IDIQ contract Maximum: ThyroSeq Test 300

Cytopathology 1200

Individual orders will be placed against the ID-IQ on an as needed basis.

Deliver to Lebanon VA Medical Center, Attn: Pathology & Laboratory Medicine Services (713), 1700 South Lincoln Avenue, Lebanon, PA 17042.

Period of Performance

05/01/2021 through 04/30/2026

Contractor Responsibilities

Provide all supplies necessary to transport the specimens to include:

Lab test request forms

Specimen shipping containers

Special instructions for handling of specimen

Transportation envelopes or packs with tracking air bills

Pre-paid shipping and packing for use with UPS, USPS, or FED-EX.

A Laboratory User s Manual or similar documentation will be provided to the Lebanon VA laboratory. The manual shall include the testing methodology used for each test, test reference ranges, and specimen requirements and any special handling required.

Transport samples in such a manner as to ensure the integrity of the specimen. Contractor will supply any special preservatives required for specimen preservation. All specimens shall be shipped in containers provided by contractor.

Analyze samples. The molecular test used for evaluating indeterminate thyroid nodules should have high specificity and sensitivity for malignancy, high predictive value, and should employ an extensive panel of thyroid-related gene mutations for detection. The test should be able to use small biopsy samples and should have rapid reporting turn-around-time. The contractor shall return the test results to the Lebanon VA laboratory within established time-frames.

Contractor shall provide the Lebanon VA laboratory with a means of communication to permit immediate inquiry regarding the status of pending test.

Contractor shall consult with the Lebanon VA laboratory on test results by telephone when urgency of situation requires.

The Lebanon VA laboratory reserves the right to request the results of any proficiency testing that the contractor subscribes.

Contractor shall provide monthly invoices via Tungsten for tests provided by the 20th of each month following the month in which the service was delivered.

The testing laboratory will be a CLIA-licensed and CAP accredited laboratory that undergoes regular proficiency surveys of their testing. Documentation shall be provided to VA laboratories upon request.

Reporting of Test Results

A report is defined as a printed final copy of laboratory testing results. Each test report shall at a

minimum indicate the following information:

Patient s full name and identification code or last 4 digits of Social Security Number

Physician s name

Lebanon VA Laboratory accession number

Submitting Laboratory Name- Lebanon VA Medical Center

Submitting facility account number

Patient s location (clinic/ward)

Test(s) ordered

Date/time of specimen collection

Date/time specimen received in Reference Lab

Date/time test completed

Test result(s)

Morphology turnaround time is 5 days from pick-up at Lebanon VAMC

ThyroSeq turnaround time is 10 days from pick-up at Lebanon VAMC

Flag abnormal results

Reference Range (if applicable adjust for age, sex and race)

Toxic and/or therapeutic range where applicable

Name of testing laboratory (contractor and/or subcontractor)

Testing laboratory specimen number

Type of specimen

Interpretation of results to include comments related to the test provided by the submitting lab

Information that may indicate a questionable validity of test results

Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

Hard copy Report(s) shall be sent by courier or may be faxed to 717-228-5962.

Reimbursement per technical, professional, or global component of the applicable CPT code, dependent on services rendered based on projected annual volumes as outlined here:

Test Name

CPT

Projected Annual Quantity

Cytopathology: Fine Needle Aspiration (FNA) evaluation

88173

150

ThyroSeq Test

0026U

30

Quality Control

Contractor shall notify the Lebanon VA Laboratory Director (or designee) immediately by phone or email of any testing errors or defective tests. The notification shall be followed up by a written statement with recommended actions to take to remedy or resolve the situation. If the Contractor has defects or errors in their testing procedure that caused erroneous results, the Contractor shall repeat the test at no charge to the VA or provide a credit to the VA. The choice of which will be discussed between the VA and the Contractor.

For quality purposes, tests routinely performed in duplicate should be indicated.

Testing Changes

The Contractor shall advise the VA laboratories of any changes in assay methodology, procedures, reference ranges and any new tests introduced.

If the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the Lebanon VA Laboratory Director (or designee) prior to the intended change. The contractor shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved.

Lebanon VA Laboratory Responsibilities

The Lebanon VA Laboratory will provide laboratory specimens prepared in accordance with the contractor s Laboratory User s Manual. All specimens will be properly identified and labeled for

testing.

The VA Laboratories will ship clinical specimens to the contractor Monday through Friday, excluding weekends and Federal Holidays. If a specimen is drawn on a weekend or holiday and can be preserved, it will be shipped on the next regular business day. All specimens will be properly stored in accordance with the policies and procedures of the reference lab.

Privacy/Custody of VA Information

The C&A requirements do not apply, and a Security Accreditation Package is not

required.