36C26318R0650-002.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition Diagnostic Laboratory Testing Services

Acquisition Plan Action ID: VA263-18-AP-4767 / 2237 - 636-18-4-4027-0530.

1. Contracting Activity: Department of Veterans Affairs, VISN 23, Network Contracting Office 23, 316 Robert Street N, Suite 506, St Paul, MN 55101. Purchase request 636-18-4-4027-0530.

2. Nature and/or Description of the Action Being Processed: This procurement is for a new fixed price Indefinite-Delivery Indefinite-Quantity (IDIQ) contract to be awarded on a sole source basis for Clinical, Molecular, and Pathology laboratory testing services for the Iowa City Health Care System (ICHCS), Pathology and Laboratory Medicine Service in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements. The performance period will be for two years (ordering period one: September 1, 2018 to August 31, 2019, estimated amount and ordering period two: September 1, 2019 to August 31, 2020, estimated amount with one option to extend services up to six months, estimated spend

. The maximum spend amount on this IDIQ contract shall be

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This request is for Clinical, Molecular, and Pathology (diagnostic) laboratory testing services to include but not limited to: Clinical, Cyto, Dermato, Hemato, Molecular, Neuro, Renal (Anatomical) Pathology and Flow Cytology. All testing must be completed by a Clinical Laboratory Improvement Amendments (CLIA) – certified laboratory or a laboratory meeting the equivalent requirements as determined by Centers for Medicare & Medicaid Services (CMS) per Fed Register. 2003(Jan 24):3713 [42CFR493.1291(c)] §493.1242 Standard: Specimen submission, handling, and referral. Testing services will be made available during regular business hours and when needed, during off hours, weekends and holidays with Pathology laboratory staff consent.

These tests cannot be shipped out of town due to quality, specimen stability, or timeliness (turnaround time.) The contractor will provide direct data review, real time consultation and preliminary result reports when requested. The period of performance will be from 09/01/2018 to 08/31/2020 with an estimated value of with 6 month extension) and a maximum value of

. There will be one option to extend services but no option year periods in this requirement.

4. Statutory Authority Permitting Other than Full and Open Competition: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This request is for local Clinical and Anatomical Pathology laboratory testing services provided by the University of Iowa Diagnostic Laboratories (UIDL) that is not performed in our laboratory but must be done on labile specimens where stability is required (therefore this precludes shipping the specimen) and/or testing that must be completed on a STAT (immediate) basis or within an hour for stability or diagnostic reasons. Testing services will be available during regular business hours, off hours, weekends and or on holidays with

VHAMINNabitL Sticky Note Accepted set by VHAMINNabitL

Pathology staff consent. The contractor will provide direct data review, real time consultation and preliminary result reports when requested. Based on their location near the VA (no shipping required) and their willingness to complete testing on a STAT basis, UIDL is the only known vendor.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An internet search was conducted in and around Iowa City for local hospitals and clinical laboratories on the required testing listed above. Market research was also conducted by professional and peer interaction and personal knowledge. A sole source intent notice, 36C26318R0650, was posted on fbo.gov on June 7, 2018 with a response date of no later than June 22, 2018. As of June 21, 2018, no responses or comments have been received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The proposed quote will be compared to the current contract prices and past procurements to help determine if the price is fair and reasonable. Certified cost and price data is not required for this contract, but an informal analysis of the past and current quoted prices will be reviewed. Also, any historical increases or decreases will be considered as well as local consumer price indexes.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted using Internet searches, personal telephone calls, professional interaction and knowledge, peer review, past experience with laboratories in and around Iowa City, public and contract price lists, FBO searches/postings, FPNG search, and VIP VetBiz searches. The VIP VetBiz Registry was checked for Veterans First Contracting Program compliance. The result of the check revealed zero SDVOSBs and zero VOSB with the NAICS code 621511 in the state of Iowa. None of the queried hospitals or laboratories provided the menu of testing needed under the required time constraints (one (1) hour). Many of the hospitals queried send this type of testing to UIDL. UIDL is a very good, nearby, fully accredited (CAP and CLIA) Clinical Laboratory able to process and test specimens in a very short (1 hr) window of opportunity for optimal specimen quality. No other local reference testing facility could provide this type of testing on a STAT (one hour turn around 24 hours / 7 days a week) basis. UIDL is the only identifiable sole source for these requirements.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The level of complexity of laboratories performing these required tests is very high which presents a substantial barrier of entry for competitors. We have no Professional knowledge of the availability of another laboratory with the required menu of tests within a 15-minute delivery time. We are fortunate that UIDL is willing to enter into a contract and provide this testing for us. Most other health care related entities in this area also use UIDL’s services.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other source solicited;

this is a sole source requirement.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Pathology and Laboratory Medicine Service will continue to investigate the availability of other local nearby sources who are CLIA certified and able to provide Clinical, Molecular, and Pathology laboratory testing services on a 24-hour 7 day a week and STAT basis. If others become available in the limited local area, they would be considered.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Name: Date Title: Laboratory Manager Facility: Iowa City VAHCS

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Date Title: Contracting Officer and Branch Chief, Medical Sharing Team 2 Facility: NCO 23 Contracting

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

Name: Date Title: Division Chief I

Facility: NCO 23 Contracting

22 June 2018

Date: 2018.06.22 12:16:26 -05'00'

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6/27/2018

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