J and A FAR Part 13 Non GYN_Final_signed__Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 10300 Spotsylvania Avenue, Suite 400

Fredericksburg, VA 22407

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL PRODUCTS OR COMMERCIAL SERVICES IN

ACCORDANCE WITH FEDERAL ACQUISITION REGULATION (FAR) 13.5

(1) Identification of the agency and contracting activity, and specific identification of the document as a “Sole Source Justification Under Simplified Procedures for Certain Commercial Products or Commercial Services in Accordance with Federal Acquisition Regulation (FAR) 13.5.”

This sole source justification under simplified procedures for certain commercial services is executed by the Strategic Acquisition Center (SAC), on behalf of the Department of Veterans Affairs (VA), VA Central Office, Pathology and Laboratory Medicine (11DIAG2).

(2) The nature and/or description of the action being approved.

The proposed action is for a sole source, firm-fixed price (FFP) contract for VHA Pathology non-GYN assessment services under FAR 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. This is a follow-on contract of 36C10G20C0010, which is currently a FFP contract.

(3) A description of the supplies and/or services required to meet the agency’s need, including the estimated value.

The Veterans Health Administration (VHA) Pathology and Laboratory Medicine Service (PLM) requires a contractor to provide non-gynecological (non-GYN) assessment services for all VHA medical laboratories that perform non-GYN patient testing. The market for medical laboratory assessment testing is highly specialized. The non-GYN assessment services must be provided by a Center for Medicare and Medicaid Services (CMS) approved Cytology Proficiency Testing vendor. Assessment services must fit within the quality management guidelines mandated by VAH Directive 1106 and the oversight authority given to the VA in 38 CFR 17.3500.

38 CFR 17.3500 -- VA application of 42 CFR part 493 standards for clinical laboratory operations

VHA Directive 1106 -Pathology and Laboratory Medicine Service

Strategic Acquisition Center (SAC) 10300 Spotsylvania Avenue, Suite 400

Fredericksburg, VA 22407

41 U.S.C. 1901, Simplified Acquisition Procedures

This acquisition is conducted under the procedures of FAR Subpart 13.5, used in accordance with the authority of 41 U.S.C § 1901. FAR 13.5 authorizes the use of FAR Part 13, Simplified Procedures for Certain Commercial Products and Commercial Services. Acquisitions conducted under simplified acquisition procedures are exempt from the competition requirements listed in FAR Part 6. FAR 13.501(a)(1). Instead, Contracting Officers are required to promote competition to the maximum extent practicable. FAR 13.104. FAR Part 13 requires the agency to justify in writing sole source acquisitions. FAR 13.501(a)(1)(i). The agency may solicit from only one source if the circumstances of the contract action deem only one source reasonably available.

FAR 13.106-1(b)(1)(i).

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The services requested in this action are highly specialized. Clinical laboratory continuous quality management mandated by federal law and VHA Directive 1106.

Centers for Medicare and Medicaid Services (CMS) approves Proficiency Testing vendors who produce services that meet federal requirements for inclusion in laboratory quality management programs. The non-GYN assessment services must meet these same standards and be supplied by a CMS approved vendor.

Two approved vendors were found on the CMS database:

- American Society of Clinical Pathology (ASCP)

- College of American Pathologists (CAP)

Of the 2 CMS approved vendors, only ASCP meets all of the requirement’s needs including: Multiple graded virtual events, individualized peer comparison, VA to Non-VA assessment and historical activity that is trackable by facility and participant across time. CAP was reviewed and it was determined that the assessment method and resulting assessment did not meet the Government’s need.

Accordingly, ASCP is the only vendor capable of providing the services described above without the VHA experiencing substantial duplication of cost that could not be expected to be recovered through competition and cause unacceptable delays in fulfilling its requirements.

Strategic Acquisition Center (SAC) 10300 Spotsylvania Avenue, Suite 400

Fredericksburg, VA 22407

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was conducted for the anticipated need. This effort did not yield any additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Federal Business Opportunities site, www.sam.gov, in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

Laboratory assessments are highly specialized and the requirement that the vendor must be approved by the CMS to quote Cytology Proficiency Testing, limiting the pool of potential vendors to 2.

This CMS approval information was checked to determine if additional vendors have been added since the last contact was awarded, no additional vendors were identified.

Cytology Proficiency Testing | CMS

(7) The anticipated dollar value of the proposed acquisition, including options if applicable and a determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. [

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, or other information as made available.

(8) A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted in accordance with FAR Part 10 by conducting a web-based search of vendors who provide cytology assessment services that are approved by CMS. While two approved vendors were identified, CAP did not meet the Government’s need. This resulted in one large non-profit open market vendor being identified.