Sources Sought Notice – Q– Thyroseq(v2) Next Generation Sequencing Testing Services

Notice Type: Sources Sought Notice

Posted Date: 03-FEB-17

Office Address: Department of Veterans Affairs;VAMC Providence;830 Chalkstone Avenue;Providence RI 02908

Subject: Q-- Thyroseq(v2) Next Generation Sequencing Testing Services

Classification Code: Q - Medical services

Solicitation Number: VA24117Q0177

Contact: Valerie DeAngelisContracting Specialist 401-459-4760 x1594 mailto:valerie.deangelis@va.gov

Description: Department of Veterans Affairs

Providence VAMC

Department of Veterans Affairs Medical Center

Department of Veterans AffairsVeterans Health Administration

Sources Sought Notice Obtain Thyroseq (v2) Next Generation Sequencing Testing Services

This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of

conducting market research to enhance VHA s understanding of your company s offered services and

capabilities. The Government will not pay any costs for responses submitted in response to this Sources

Sought Notice.

This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and

their available products in response to the requirement described below. Vendors are being invited to

submit information relative to their potential of fulfilling the requirement below, in the form of a

capability response that addresses the specific requirement identified in this Sources Sought.

The Veterans Health Administration (VHA) is seeking to obtain Off-Site Thyroseq (v2) Next Generation Sequencing testing services to detect point mutations and gene fusions for indeterminate thyroid fine needle aspirates (FNAs) for the Department of Veterans Affairs Medical Center, VA VISN 1 Laboratories (herein referred to as VAMC). The services shall be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section as described below. contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).

Refer to the General Requirements section below for the requested service description. This

Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition

planning, size determination, and procurement strategy.

General Requirements:

The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to these testing services as defined below except for those items specified as government furnished property and services.

Objective:

Obtain ThryoSeq Next Generation Sequencing testing services estimated at 20 per year

Scope:

The VAMC will send a contractor provided requisition form containing at a minimum the patient s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider, sample type and date of birth (second identifier). For specialized testing, the VAMC will provide a brief clinical history when necessary.

Locations that will utilize these testing services:

VA West Roxbury 1400 VFW Parkway, West Roxbury, MA 02132;

VA Connecticut, West Haven Campus, 950 Campbell Ave, West Haven, CT 06516;

VA Providence, 830 Chalkstone Ave, Providence, RI 02908;

VA Maine, 1 VA Center, Augusta, ME 04330;

VA Manchester, 718 Smyth Road, Manchester, NH 03104;

VA White River Junction, 215 North Main Street, White River Junction, VT 05009

The Contractor Laboratory shall:

Accept the unique facility National Provider Identifier (NPI) number and not require an NPI for each individual ordering practitioner.

Perform analytical testing for VAMC patients for the tests. The Contractor shall bill only for the tests specified in the request sent by the VAMC Laboratory service and that are contained in the test menu.

Provide test results in a turnaround time of 15 days or less.

Provide a reference test manual, and report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations.

Provide VAMC with appropriate laboratory supplies (collection tubes and shipping kits) not customarily utilized by the VAMC. These supplies are to be used by the VAMC only in connection with specimens being sent for testing to the contractor.

Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.

Provide test result reports/consults by fax to the send-out office of the sending VA or make results available within the online web portal for review. contact information to be provided upon contract award.

Provide a consultation/laboratory result report that at a minimum shall contain the following information:

Patient s full name

Patient s date of birth

Patient s full social security number or unique hospital identification number

Ordering Physician s name

Date/time of specimen collection, when available

Date/time test completed

Test(s) ordered

Test result(s)

Flagged abnormal results

Type of specimen/source

Any additional comments related to test provided by ordering physician, if applicable

Unsatisfactory specimen shall be reported with regard to its unsuitability for testing

VAMC Lab accession number, if supplied

VAMC submitting facility name

Patient location if supplied

Date/time specimen receipt

Abnormal intervals/Toxic & therapeutic ranges, if applicable

Any other information the laboratory has that may indicate a questionable validity of test results.

VAMC facility account number

Contractor accession number

Contractor address

Contractor CLIA number

Reference intervals

Testing laboratory name

Consult with VAMC on test results by telephone as needed.

Provide a printed or electronic Laboratory Manual containing the following information:

Testing methodology for a test must be defined in the laboratory user s manual

Department hours of operation

Accreditation

Technical Staff

Service Departments (Method of contacting, phone numbers, hours of availability)

Quality Assurance Information

Billing Procedures & fee schedules for services provided

Procedures and criteria for phoning reports and other important information

Report forms

Provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving on weekdays. *NOTE: Also include names and telephone number(s) of Technical Directors and Pathologists available for consultation.

Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

Assign a specific local account representative.

Advise VAMC facility of any planned changes in methodology, procedure or reference ranges at least 14 days prior to changes. In the event that two week notification is not possible due to emergency, contractor shall notify VAMC as soon as possible.

Not release patient s records that include test results to any person other than the ordering healthcare provider or VA Pathology and Laboratory Medicine staff member. All member records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient s records. This provision shall survive termination of the resulting contract award.

Certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the sending VA site laboratory administration and to the VISN1 Network Consolidated Laboratory office (NCL) at no additional cost to the Government. The reports will be in Microsoft excel format and include at a minimum the following column headers: patient name, date of service, CPT code, test name/procedure, volume, cost per test, total cost. The data will be in the rows. These reports shall be forwarded to the sending VA site and NCL within 30 days of the end of the quarter.

Licensing and accreditation Contractor Laboratory:

1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law.

2. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory s Laboratory Director(s) and/or Medical Director(s).

3. Medical Director(s) must have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards.

4. Personnel assigned to perform the services shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

5. Must comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS).

6. Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.

7. Shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

Contract Performance Monitoring:

Quality Control: The contractor shall operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with this Performance Work Statement (PWS). The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract.

The VA Medical Center will maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VA Medical Center and may include, but is not limited to , unidentified split specimens sent periodically to the contractor for testing, split specimen sent to another reference laboratory for comparison, or monitoring of turn-around-time.

The contractor s facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the VAMC during the life of the contract.

Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required for performing the type of services described herein. The government shall evaluate the contractor s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Federal Holidays: (The contractor does not have to perform on these holidays)

New Year s Day Labor Day

Martin Luther King Jr. s Birthday Columbus Day

President s Day Veteran s Day

Memorial Day Thanksgiving Day

Independence Day Christmas Day

Hours of Operation: The contractor is responsible for providing services 8:00 am - 4:30 pm EST Monday Friday. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract.

Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend a post award conference convened by the contracting activity in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, shall meet periodically with the contractor to review the contractor's performance. At these meetings, the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

Contractor Program Manager: The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons.

Identification of Contractor Employees:

All contract personnel attending meetings, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

Contractor Furnished Items and Responsibilities:

The Contractor shall furnish all supplies, equipment, facilities and services required to perform work as outlined in this contract.

RESPONSE COMMITMENT

I. NOTES:

A. All questions, comments or concerns shall be directed to Valerie.DeAngelis@va.gov

B. Submittals furnished will not be returned to the sender. No debriefs will be conducted.

Eligibility to participate in a future acquisition does not depend upon a response to this

notice.

C. Proprietary information is neither requested nor desired. If such information is

submitted, it must clearly be marked "proprietary" on every sheet containing such

information, and the proprietary information must be segregated to the maximum extent

practicable from other portions of the response (e.g., use an attachment or exhibit).

II. TIMELINE:

A. This request will close 4 business days after this notice is published on the FBO site.

III. Requested information:

Interested parties shall provide the following information in addition to your capability response:

A. Format:

1. MS Word or pdf format (please ensure email is under 5 mb)

2. Page limit 2-4 pages (please make the response as brief and concise as possible)

3. Company name and Sources Sought number listed on each page

B. Specifics:

1. In your response, please provide the following information based on the

requirement.

a. Your company s capability of fulfilling this requirement as it is

described.

2. Please also provide name of company, company address, a contact person s

name, telephone number, fax number and email address.

3. DUNS number, and indicate if actively registered on System for award

management (SAM)

4. Contractual vehicles the company holds, such as NAC or GSA schedules.

5. Socio-economic Status & NAICS Code: State the size of your company [e.g.,

8(a) (including graduation date), HUBZone-certified small business, Service-

Disabled Veteran-Owned small business, small business, large business, etc.].

Notes:

1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or

otherwise, that a procurement action will follow. The Department of Veterans Affairs will use the

information submitted in response to this notice at its discretion and will not provide comments to any

submission; however, The Department of Veterans Affairs reserves the right to contact any respondent to

this notice for the sole purpose of enhancing The Department of Veteran Affairs understanding of the

notice submission.

2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for

content marked or designated as business confidential or proprietary which will be fully protected from

release outside the government.

The Department of Veteran Affairs Contracting Office Point of contact:

Valerie DeAngelis

Contracting Officer

Email: Valerie.DeAngelis@va.gov

Link/URL: https://www.fbo.gov/spg/VA/PrVMAC650/PrVAMC650/VA24117Q0177/listing.html