36C26318Q0277-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Q Fargo VA Thyroid Biopsy Testing (Afirma FNA) 55101 36C26318Q0277 03-09-2018 N 621511 Department of Veterans Affairs

NETWORK 23

CONTRACTING OFFICE

ATTN: Scott Hendrix 316 Robert Street N.

St. Paul MN 55101 Scott Hendrix scott.hendrix@va.gov Department of Veterans Affairs Fargo VA Health Care System 2101 Elm Street N.

Fargo, ND 58102

USA

Scott.Hendrix@va.gov

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Contracting Office Address Department of Veterans Affairs Network Contracting Office 23 Warren E. Burger Federal Building and U.S. Courthouse 316 Robert Street N.; Suite 506 St. Paul, MN 5101 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document is also attached.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-97 effective 01/24/2018.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $32.5 Million.

The Network Contracting Office 23, Warren E. Burger Federal Building and U.S. Courthouse 316 Robert Street N.; Suite 506; St. Paul, MN 5101 is seeking to purchase Thyroid Biopsy Testing.

All interested companies shall provide quotations for the following:

Services Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to act as our reference lab in the provision of gene expression classification services as a reference lab to the Fargo VA Health Care System described herein. Reference Laboratory Services include, but are not limited to: specimen preparation and storage; performance of analytical testing; reporting of analytical test results; and consultative services.

I. Specimen Preparation and Storage for Reference Testing Specimens

1. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

1. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the Contractor for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the Contractor.

1. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen.

1. Transportation Services for Reference Testing Specimens

1. Contractor shall provide transportation of primarily biomedical materials that include patient specimens Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

1. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

1) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

2) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

3) Test request forms, preprinted with the appropriate Shipping Section details and account information.

4) Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.).

1. Specimen Testing

1. The Contractor shall provide testing using tissue extracted during a fine needle aspiration. Contractor is requested to provide genomic sequencing to determine the expression profile of the mRNA. This test must use the expression profile to determine benign or suspicious for malignancy resulting for the submitted tissue. The Contractor is requested to offer BRAF and RET/PTC mutation testing in addition to the genomic sequencing classification to help determine the extent of surgery.

1. Contractor shall make available the following test information:

1. Requisition form requirements

1. Specimen collection and preservation requirements

1. Test method employed (indicate if testing performed in duplicate) and interpretations

1. Test reference intervals adjusted for age, sex or race, when required

1. Test specific sensitivity, specificity and interferences, when required

1. Test critical values, if any

1. Policy for critical value notification

1. Report Turn-around time will be within 14 days from the date on which the Contractor receives the specimen

1. Testing shall be performed Monday-Saturday Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

1. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

1. The Contractor shall ensure the accurate and timely performance (defined in Section III.B.8) of laboratory testing services on the biomedical materials.

1. Reporting of Results

1. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section III.B.8).

1. A report of laboratory testing results must be transmitted as a printed copy by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited.

1. Each test report generated in hard copy form shall, at minimum, include the following information:

1. Patient's full name

1. Patient’s identification number, e.g. social security number (SSN)

1. Physician’s name (if supplied)

1. Submitting facility name

1. Submitting facility account number

1. Test(s) ordered

1. Date/time of specimen collection (when available)

1. Date/time test completed

1. Test result

1. Reference intervals (adjusted for age, sex or race, when appropriate)

1. Toxic and therapeutic ranges, if applicable

1. Flagged abnormal results

1. Reference laboratory accession number

1. Name and address of testing laboratory

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

1. Specimen inadequacy with documentation supporting its unsuitability for testing.

1. Customer Service

1. Contractor shall provide customer service that is accessible during Contractor’s business hours Monday-Friday 7:00am-5:00pm to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

1. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

1. Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

1. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

1. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

1. Testing

1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

1. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

c. Technical Expertise

1. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

1. Result interpretation inquiries shall be addressed within four business hours of initial call.

3) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

d. Account follow-up

1. Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

1. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

1. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

1. Consultative Services/Utilization Reports

1. Contractor shall provide consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

1. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

The delivery/task order period of performance is April 1, 2018 through March 31, 2019 with four 12-month option periods (See Schedule of Services).

BASE PERIOD – April 1, 2018 Through March 31, 2019

Place of Performance: Contractor’s Facility

Award shall be made to quoter whose quotation is the lowest price technically acceptable (LPTA). The government will evaluate information based on the following evaluation criteria: Technical acceptability and Price.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” JAN 2017

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” NOV 2017

Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” JAN 2017

· To include the following Addenda:

· 52.216-18 Ordering

· 52.216-19 Ordering Limitations

· 52.216-22 Indefinite Quantity

· 52.217-8 Option to Extend Services

· 52.217-9 Option to Extend the Term of the Contract

· 52.232-19 Availability of Funds for the next Fiscal Year

· 852.203-70 Commercial Advertising

· 852.232-72 Electronic Submission of Payment Requests

· 852.237-70 Contractor Responsibilities

· 52.204-18 Commercial and Government Entity Code Maintenance

· 52.224-1 Privacy Act Notification

· 52.224-2 Privacy Act

· 52.227-14 Rights in Data – General

· 52.232-40 Providing Accelerated Payments to Small Business Sub-Contractors

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” Nov 2017

· The following subparagraphs of FAR 52.212-5 are applicable:

· Subsection (a) in its entirety

· Subsection (b):

· (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109–282) (31 U.S.C. 6101 note).

· (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

· (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)).

· (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

· (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

· (28) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

· (30) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

· (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627).

· (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)

· (45) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

· (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

· (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

· Subsection (c):

· (2) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67).

· (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

· (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

· (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

· (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

· Subsection (d) in its entirety

· Subsection (c) in its entirety

All quoters shall submit the following: See Proposal Submittal Instructions within the attached Solicitation.

All quotations shall be sent t0: See Proposal Submittal Instructions within the attached Solicitation.

This is an open-market combined synopsis/solicitation for Thyroid Biopsy Testing services as defined herein. The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

Submission shall be received not later than 1:00pm CST on 03/09/2018 via email to scott.hendrix@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contracting Officer at scott.hendrix@va.gov.

Point of Contact Scott Hendrix at scott.hendrix@va.gov.

See attached document: S02 36C26318Q0277.

See attached document: S02 Attachment 1 - QASP.

See attached document: S02 Attachment 2 - Immigration and Nationality Act Certification.

See attached document: S03 Combined synopsis - solicitation 02.