P03 HCA Signed - Limited Source Justification Over SAT - Saginaw Ref. Lab Testing Svcs.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

Effective Date: 02/01/2022 Page 1 of 4

ADEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) Orders Over the Simplified Acquisition Threshold

(>SAT)

Acquisition Plan Action ID: 36C250-23-AP-3451

1) Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 10, Station 655, (Saginaw VA Medical Center) located at 1500 Weiss Street, Saginaw, MI 48602, has submitted a request to Network Contracting Office (NCO) 10, located at 8888 Keystone Crossing, Suite 1100, Indianapolis, IN 46240 a limited source procurement with ARUP Laboratories (ARUP) through PR-IFCAP 655-23-3-039-0005.

2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule (MAS) Program (41 U.S.C. 152(3) and 40 U.S.C. 501). ARUP is the current contractor being used for reference laboratory testing for the Saginaw VAMC.

Order against: FSS Contract Number: 36F79720D0079 with current expiration date of 3/31/2025 and an ultimate completion date of 3/31/2030 which includes any remaining options.

Name of Proposed Contractor: ARUP Laboratories Street Address: 500 Chipeta Way City, State, Zip: Salt Lake City, UT 84108 Phone: 800-583-2787

3) Description of Supplies or Services: The estimated value of the proposed action is $784,163.03.

ARUP is the current contractor being used for reference laboratory testing for the Saginaw VAMC through task order 36C25022F0196 which expires 5/31/2023. This procurement will be for a period of one year from 06/01/2023 – 5/31/2024. Testing will be for the patients of the participating facility.

The tests provided for the facility shall be varied and based on the facility needs and the testing orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the facility.

There are currently 1,784 different tests requested to be on the task order with a combined total of 21,259 tests.

4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; The medical center is currently utilizing ARUP through task order 36C25022F0196 which expires on 5/31/2023. While there are two other FSS companies that could provide this testing, switching companies at this juncture would not be in the best interest of the government, as it would take just as long to bring on a new temporary laboratory contractor to provide services for this proposed action as it would for the long-term Blanket Purchase Agreement (BPA) that will be competed, awarded and implemented under FAR 8.405-3 procedures amongst the reference laboratory FSS contract holders.

It will take approximately 3-12 months to code and implement an award to a new contractor.

However, ARUP already is established and has the test list built. When laboratory services are obtained, the list of tests needs to be entered into the IT systems for the tests to correlate with the http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf https://www.acquisition.gov/far/part-8#FAR_8_405_6

Effective Date: 02/01/2022 Page 2 of 4

VAMC and the contractor. It takes several months to build, test, and ensure there are no issues requesting tests.

It is required that the medical center has continuity of services for reference laboratory testing. Not having these services could be detrimental to providing patient care. Continuing with a new one-year task order with the current contractor will ensure no interruption of testing while the new long-term FSS BPA is being planned, solicited, awarded, and implemented.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule (FSS) order provided that the original order was placed in accordance with the applicable FSS ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright, or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The Contracting Officer (CO) believes awarding this task order to the current contractor represents the best value to the government as the current contractor (1) is uniquely positioned, due to the existing infrastructure and established processes, to continue to provide the required services with no possibility of delay and/or interruption in services, and (2) is the only company that can commence providing services under a new task order by 6/1/2023. Prices were determined to be fair and reasonable by the National Acquisition Center (NAC) CO at the time the FSS contracts were awarded. In accordance with FAR 8.405-4, the CO will seek additional price reductions.

6) Describe the Market Research Conducted: A search was conducted in the Small Business

Administration (SBA) VetCert database using North American Industry Classification System (NAICS) code 621511, which yielded 221 results. A search was conducted in the SBA Dynamic Small Business Search (DSBS) database for eligible Service-Disabled Veteran Owned Small Business and Veteran Owned Small Business (SD/VOSB) concerns using NAICS code 621511 and keywords “Reference Laboratory Testing” and services. There were zero (0) results.

While market research found 221 results through a search of the SBA VetCert database using NAICS code 621511, and 0 results through the search of the SBA DSBS database using NAICS code 621511 for SD/VOSB concerns using keywords “Reference Laboratory Testing”, and services; none can provide immediate services as needed. The VA and SBA Rules of Two are not met.

A search was conducted in the SBA DSBS database for eligible Small Business (SB) concerns using NAICS code 621511 and keywords “Reference Laboratory Testing” and services. There were zero (0) results.

A search was conducted in the General Services Administration (GSA) e-Library for laboratory testing services. FSS Schedule 621 II was located. This schedule contains categories 621-200 through 621-212.

1. The VAMC requires a contractor that can provide testing within all categories 621-200 to 621-

212.

2. A review by the CO located 3 large businesses that have the capability to provide testing in all required categories:

a. ARUP, Contract 36F79720D0079, with a current expiration date of 3/31/2025.

Effective Date: 02/01/2022 Page 3 of 4

b. Laboratory Corporation of America (LabCorp), Contract V797D-50532, with a current expiration date of 12/31/2026.

c. Quest Diagnostics (Quest), Contract V797D-70090, with a current expiration date of 3/31/2027.

7) Any Other Facts Supporting the Justification: Establishing a short-term task order with ARUP will allow the Saginaw VAMC and associated Saginaw clinics the ability to seamlessly transition to the new electronic health record (EHR) system under the Electronic Health Record Modernization (EHRM) initiative without any interruptions in patient care. When laboratory services are obtained, a new list of tests needs to be entered into the IT systems for the tests to correlate with the VAMCs and the reference laboratory contractor. It takes several months to build, test, and ensure there are no issues requesting tests. As the EHRM contractor will have to build these tests into the new EHR system, and the roll out of each site is different, it has been determined that the Saginaw VAMC needs to be transitioned under EHRM prior to implementing the new long-term BPA to avoid the risk of interruptions in patient care. Having the Saginaw VAMC transitioned under EHRM before the new long-term BPA is implemented will provide a shorter implementation period as all major laboratories will have been built into the new EHR system.

Concerning the new long-term FSS VISN BPA, VA Lab Managers for the multiple VISN 10 sites are working together to develop a procurement package that encompasses the needs for each facility that includes the latest advancements in the current commercial markets. The new FSS BPA will result in a BPA with a base year plus four, one-year options with an estimated cost of approximately $24 million. It is estimated that a year will be needed for continued services while the new long-term BPA is being planned, solicited, awarded, and implemented.

8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Market research and acquisition planning will be conducted to ensure that the new, long-term BPA is established under competitive procedures in accordance with FAR 8.405-3.

9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Darcy Cox Laboratory Manager Saginaw VA Medical Center

10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Sally L. Leitch Contracting Officer Network Contracting Office 10 Services Team 3 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx

Effective Date: 02/01/2022 Page 4 of 4

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding

$750K): I certify the justification meets requirements for other than full and open competition.

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Terry L. Spitzmiller Executive Director Regional Procurement Office Central (VHA)

Toni Waggoner-Boykin, Branch Chief Services Team 3 Network Contracting Office (NCO) 10

Jason E. Lawson, Division Chief General and Healthcare Services

Marie L. Smith Director of Contracting

Attachment 2: Market Research Report

Effective Date: 03/01/2022 Page 1 of 14

Reference Laboratory Testing Services

PART I –

I. Authority.

Market research is required in accordance with:

FAR 7.102, Acquisition Planning Policy FAR 7.103(u)(1) and (2), Agency-Head Responsibilities FAR 10.001, Market Research Policy and VAAR 810.001-70 (Class Deviation) VAAR 813.003-70(c), Policy (Class Deviation) FAR 19.202-2, Locating Small Business Sources and VAAR 819.202 (Class Deviation) FAR 25, Foreign Acquisition

II. Procurement Information.

A. Procurement History.

ARUP Laboratories is the current contractor being used for reference laboratory testing for the Saginaw VA Medical Center. Testing will be for the patients of the participating facility. The tests provided for the facility shall be varied and based on the facility needs and the testing orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the facility.

It is estimated that a year will be needed for continued services while a new long-term contract BPA is being sought, evaluated, allow ample competition, and transition amongst reference laboratory contract holders.

1. Was the requirement previously procured?

Saginaw - 36C25022F0196 ARUP Laboratories, Inc. $ 782,755.10 Saginaw – 36C25020F0471 ARUP Laboratories, Inc. $537,046.24

2. ARUP Laboratories is a large business.

3. There have been no changes in the marketplace since the previous procurement.

4. Is this a bundled (FAR 2.101) requirement? This is not a bundled requirement.

5. Are there any applicable Organizational Conflicts of Interest? There are no conflicts of interest.

B. Procurement Background.

Name Title Office Telephone E-mail Address

Darcy Cox Laboratory Manager Laboratory 989-497-2500 ext. 11604 Darcy.cox@va.gov

Type of acquisition: Service Expected dollar value of requirement: $784,163.03 Suggested 2022 NAICS code(s): 621511 – Medical Laboratories

Effective Date: 03/01/2022 Page 2 of 14

Suggested 2022 PSC code: Q301 – Medical Laboratory Testing Time frame in which the market research was conducted: 3/28/2023 to 4/24/2023

III. Initial Requirements

Describe the Government’s requirement in terms of:

o Functions to be performed: Esoteric reference laboratory testing for the patients of the participating facilities.

o Services or Performance required: Ability to send laboratory testing to reference labs to conduct testing that is not available on-site at the medical centers.

o Essential physical characteristics: All necessary supplies for specimen transport, packaging, and testing. Any specialized tubes and shipping kits required for select patient testing and courier for transportation of the specimen and any supplies required for transportation like dry ice etc.

Describe schedule requirements, e.g., performance periods and/or delivery due dates: One-year.

Discuss any cost effectiveness issues associated with the requirements: More cost effective to send tests to reference laboratory versus bringing the testing in-house.

IV. Participants in Market Research

Describe the involvement of the individual Acquisition Team members and any other participants in the market research effort.

NAME TITLE OFFICE TELEPHONE E-MAIL ADDRESS Acquisition Role

Darcy Cox Laboratory Manager

Laborat ory

989-497-2500 ext. 11604 Darcy.cox@va.gov

Acq team lead, SME, write MRR, LSJ, IGCE, SOW

Sally L. Leitch Contracting Officer (CO)

NCO 10 317-988-1538 Sally.Leitch@va.gov Approve MRR, ensure proc pkg is completed and approved.

Pak Sa Dewhurst Small Business Liaison

NCO 10 937-268-6511 PakSa.Dewhurst@va.gov GOV & Industry Liaison, advise proc. Strategy.

V. Market Research Techniques and Sources

A. Market Research Techniques Describe techniques and sources used during market research. The following table may help structure and summarize the techniques used in the market research effort.

Check X

IF USED SOURCES USED IN MARKET RESEARCH DETAILS OF

RESEARCH/COMMENTS

RESEARCH SOURCES

(INCLUDE REFERENCES TO

ATTACHMENTS TO REPORT)

(e.g., List of Journals and Literature Reviewed included as Attachment 4 to this report)

Effective Date: 03/01/2022 Page 3 of 14

X Acquisition history reviewed See A(1) above.

Other recent market research reviewed

X SBA Veteran Small Business Certification Veteran Small Business Certification (sba.gov) (including any information supporting price reasonableness)

Search conducted using NAICS code 621511. There were 221 results, the first 30 were captured.

Interviewed knowledgeable individuals in industry/Government

Participated/Attended Tradeshows and Industry Conferences

Professional Journals, Catalog and/or Product Literature reviewed

Participated in Small Business Vendor Outreach Sessions

B. Market Research Sources. In accordance with FAR part 10 and VAAR part 810, market research has been conducted for this acquisition. The following additional collaborative Contracting Officer-led techniques were used:

This section is not applicable as this is not a supply.

SOURCES REVIEWED

(IAW FAR 8.002, VAAR 808.002, FAR 8.003, FAR

8.004, and VAAR 808.004-70)

MARKET RESEARCH FOR SUPPLIES

C. Market Research Sources. In accordance with FAR part 10 and VAAR part 810, market research has been conducted for this acquisition. The following additional collaborative Contracting Officer-led techniques were used:

Insert X if Checked

VETERANS FIRST CONTRACTING PROGRAM (VAAR subpart

819.70)

REFERENCES/SOURCES CHECKED

(IDENTIFYING VETCERT VERIFIED SDVOSBs/VOSBs)

Details of Research/Comments

(Include References to Report Attachments)

X

SBA Veteran Small Business Certification Veteran Small Business Certification (sba.gov) (including any information supporting price reasonableness)

Search conducted using NAICS code 621511.

There were 221 results, the first 30 were captured.

System for Award Management (SAM) search for entity records at: SAM.gov | Search

Effective Date: 03/01/2022 Page 4 of 14

Check X if Part of Research

PRIORITY CONSIDERATION OF

VA EXISTING CONTRACTS

X

1. See VA PPM (2016-05)(Revised AUG 2019) - Implementation of the Veterans First Contracting Program (VIEWS 01368239) concerning consideration of existing VA contracts and VA strategic sourcing regarding supplies in FSC Groups 65 and 66.

Not applicable as this is not a supply

X 2. Other VA Existing Contracts (non-mandatory but their potential availability, scope, contract type, etc., should be documented in the market research report)

VA FSS Schedule 621 II

Research

CONSIDERATION OF NON-VA EXISTING CONTRACTS

Federal Strategic Sourcing Initiatives or OMB Category Management contracts/sources

(Non-Mandatory except where OMB or Agency policy states otherwise)

1. Non-VA Contracts:

(Includes NASA-SEWP and BPAs under FSS Strategic Sourcing Initiative (FSSI) non-mandatory Federal Supply Schedules (other than for FSC Group 65 and 66) (FAR 8.004(a)(1) and VAAR 808.004-70).

X 2. Non-mandatory Federal Supply Schedules (non-VA) (See FAR 8.004(a)(1) and VAAR 808.004-70, Use of non-mandatory sources by VA (Class Deviation).

VA FSS Schedule 621 II

Use of Other Sources Commercial sources (includes educational and non-profit institutions) in the open market. This is permissible IAW FAR

8.004 and VAAR 808.004-70.

Research

Sources for services to consider, as applicable and as required

Details of Research/Comments

(Include References to Report Attachments)

MARKET RESEARCH FOR SERVICES

1. Services that are on the Procurement List maintained by the Committee for Purchase from People who are Blind or Severely Disabled (AbilityOne) (See FAR subpart 8.7) See VAAR 808.002, Priorities for use of mandatory Government sources, paragraph (a)(2) pertaining to Services.

2. Services: Federal Prison Industries (See FAR subpart 8.6) UNICOR Home Page (Except if two or more SDVOSB or VOSB are identified, see VAAR 808.603)

3. Also see--VA Federal Supply Schedules (FSS) in FSC Group 62I.

4. And see--mandatory sources reviewed, if applicable, for:

4a. Public Utility Services (see FAR part 41);

4b. Printing & Related Supplies (see FAR subpart 8.8);

4c. Leased Motor Vehicles (see FAR subpart 8.11);

4c. Helium (see FAR subpart 8.5)

Effective Date: 03/01/2022 Page 5 of 14

X 5. Services: Commercial sources (includes educational and non-profit institutions) in the open market.

VA FSS Schedule 621 II, VA and SBA Rule of Two cannot be met in the open market.

VETERANS FIRST CONTRACTING PROGRAM (VAAR subpart

819.70)—REFERENCES/SOURCES CHECKED

Sources Sought Notices: Requests for Information (RFI) SAM.gov | Contract Opportunities

System for Award Management (SAM) search for entity records at: SAM.gov | Home

OTHER REFERENCES/SOURCES CHECKED

(Other ways to conduct or confirm market research)

Sources Sought Notices: Requests for Information (RFI) SAM.gov | Contract Opportunities

Pre-solicitation and/or Pre-Proposal Conferences

Existing intra-/inter-agency contract vehicles, e.g. Interagency Contract Directory (ICD) at:

https://www.contractdirectory.gov/contractdirectory

System for Award Management (SAM) search for entity records at: SAM.gov | Search

X SBA Dynamic Small Business Database at: SBA - Dynamic Small Business Search

a. SBA DSBS SD/VOSB – Search conducted using NAICS code 621511, Reference Laboratory Testing, Services, and

SDVOSB/VOSB

concerns. There were 0 results.

b. SBA DSBS - Search conducted using NAICS code 621511, Reference Laboratory Testing, and Services for all small business concerns. There were 0 results.

X Department of Labor (DoL) Service Contract Labor Standards (Service Contract Act (SCA)) and Wage Rate Requirements (Davis-Bacon Act (DBA)) wage determination information online at: SAM.gov | Wage Determinations (SERVICES ONLY)

SCA applies – will utilize FAR 52.222-49 – Place of Performance Unknown.

Effective Date: 03/01/2022 Page 6 of 14

VI. Identify Product/Services and Sources Able to Meet the Requirement

Identify or describe:

o Product/Service: Q301 Medical Laboratory Testing & Esoteric reference laboratory testing for the patients of the participating facilities.

o Product/Service characteristics and/or capabilities: All necessary supplies for specimen transport, packaging, and testing. Any specialized tubes and shipping kits required for select patient testing and courier for transportation of the specimen and any supplies required for transportation like dry ice etc.

o Company information: See table below.

o Company characteristics, past performance, and business size category: See table below.

o If sole source, describe efforts to locate additional sources: There are three major laboratories that provide all the requested services. This is a short-term requirement, to provide continued services while a long-term BPA is solicited, evaluated, and implemented, as well as continued services while site switches to the CERNER system.

Business Category Name of Potential Source(s)/Other POC Information VETCERT verified Service-Disabled, Veteran-Owned (SDVOSB)

Non-verifiable

VETCERT verified Veteran-Owned Small Business (VOSB)

Non-verifiable

Woman-Owned Small Business

(WOSB)

None located

Economically Disadvantaged Woman- Owned Small Business (EDWOSB)

None located

HUBZone Small Business None located Section 8(a) small business None located Small/disadvantaged business

(SDB)

None located

Small business None located

Large Business o ARUP 500 Chipeta Way, Salt Lake City, UT 84108 Telephone: 800-242-2787 Email: Stephanie.Millikan@aruplab.com Website: http://www.aruplab.com o LabCorp 231 Maple Avenue, Burlington, NC 27215 Telephone: 502-228-8630 Email: mcclaig@labcorp.com Website: http://www.labcorp.com o Quest 3 Giralda Farms, Madison, NJ 07940 Telephone: 615-498-7347 Email:

Michael.w.andertson@QuestDiagnostics.com Website: www.questdiagnostics.com

Effective Date: 03/01/2022 Page 7 of 14

VII. Description of the Commercial Marketplace and Prevalent Business Practices

Describe the marketplace o Standard and customary terms and conditions with industry business practices include:

A website with detailed information, diagnostic data to assist with testing utilization and savings.

Subject Matter Experts to provide consultation for providers.

Turn Around Times of less than 24 hours for critical tests.

Shipping schedule with back-up plans.

Point of Contact for issues related with sample pick-up.

A plan for how to address sample mishandling to avoid recollection, including a sample rejection rate due to mishandling.

Payment is made monthly for all the testing provided the previous month

Identify availability of commercial or non-developmental items that satisfy requirements (value or shortcomings of each) and sub-components: None.

State Nonmanufacturer Rule (NMR) Findings (if the acquisition is for manufactured products or other supplies) (See the Nonmanufacturer Rule Decision Tree to assist with this determination): Not Applicable.

Identify standard/customary terms and conditions and industry business practices that differ from the standard Government practices (include information on payment, freight delivery, acceptance, and warranties) o It is standard practice that the VA uses a reference laboratory that is CLIA certified, and CAP or Joint Commission (TJC) accredited.

Discuss if contract financing is applicable. If so, ensure compliance with FAR 32.202-3, Conducting Market Research About Financing Terms: Not applicable, contract financing will not be provided.

Discuss any regulations unique to the requirement, if known o Authority: Public Law 104-262, Title 38 USC 8153, Health Care Resources (HCR)

Sharing Authority, FAR Part 12 & 15, and VAAR 873.

o Policy/Handbooks:

VHA Handbook 1100.17: National Practitioner Data Bank Reports -https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

VHA Handbook 1100.19 Credentialing and Privileging -https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

VHA Handbook 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

Privacy Act of 1974 (5 U.S.C. 552a) as amended:

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

VHA Handbook 1106.01: Pathology and Laboratory Medicine Service (P&LMS) Procedures:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

VIII. Pricing and Market Issues

Identify price sources (e.g., market price, catalog, GSA, etc.), price ranges, and price variations: Historical and FSS pricing.

Arup:

0VUV2F.3RL816_36F79720D0079_36F79720D0079.PDF (gsaadvantage.gov)

Effective Date: 03/01/2022 Page 8 of 14

Cedar:

0VNY32.3REB1T_V797D-30073_CEDARTEXTFILE.PDF (gsaadvantage.gov) LabCorp:

0QAMS7.3DN5O3_V797D-50532_LCAFSS621II081516.PDF (gsaadvantage.gov) Quest:

0VK5BO.3RAIAF_V797D70090_V797D-70090-8-4-2020-353397.PDF

(gsaadvantage.gov)

Describe market trends for product or service, e.g., technical, business, and pricing:

Reference laboratories work with commercial and government entities to ensure that new tests are made available for use to ensure that patients are treated in a timely manner and have testing available to provide the necessary care to all persons who have labs done

IX. Other Considerations

Identify other considerations gathered from market research, e.g., opportunities for small business participation: At this time no known small business were found. Searched VetCert, SBA DSBS, and GSA.

Discuss qualifying factors, including such issues as past performance, references, product testing or evaluation, customer satisfaction, warranties, and quality problems

Describe consideration of green (sustainable products and services https://sftool.gov/greenprocurement and http://www.gsa.gov/portal/content/105365.

Include discussion of energy efficiency standards of market products, if applicable:

Not Applicable.

Discuss consideration to Buy American Statute. Does Buy American, Trade Agreement or an Exception to Buy American apply (FAR Part 25). Are there domestic end products available for this acquisition? Not Applicable.

X. Market Analysis Summary

It is very important that the VA awards a contract to a contractor who has the ability to interphase with the VA LIS System (VISTA and CERNER) to provide automatic result verification to avoid human errors when entering manual results; has a contract who can provide all the testing required and cover the full period of performance required by the VA.

Evaluation factors to determine a reference laboratory should include past performance, to Pick-Up Times, and meet Test TATs by at least 95%. A contractor that is ISO certified is preferred. The contractor should have a lost specimen percentage of less than 2%, must be able to directly report State Board of Health reportable results to the respective states.

No SD/VOSB concerns were found while conducting searches on the VetCert and SBA DSBS websites. Three large businesses were found on VA FSS 621 II who provided testing in SINS 200 – 212.

ARUP Laboratories is currently providing services and has successful past performance.

Competing a short-term requirement this large is not in the best interest of the government as the services are critical in timely treatment of patients. If a new contractor takes over in the short-term it could take 3-12 months to interface their system with the VA. ARUP is currently interfaced and providing timely services and could continue doing so without interruption.

Effective Date: 03/01/2022 Page 9 of 14

XI. DETERMINATION: It is recommended that the CO award a one-year, sole source, fixed price, interim task order to ARUP Laboratories as the VA and SBA Rules of Two cannot be met. ARUP is currently providing services and would be able to continue providing services without interruption to timely patient care.

Name: __Darcy Cox – Contracting Officer Representative Date: __4/12/2023______

MRR supplemented by CO on 5/9/2023.

PART II –

I. Contracting Officer Responsibilities:

I. Background.

Title: Reference Laboratory Testing Services for the Saginaw VA Medical Center (VAMC).

ARUP Laboratories is the current contractor being used for reference laboratory testing for the Saginaw VA Medical Center. Testing will be for the patients of the participating facility.

The tests provided for the facility shall be varied and based on the facility needs and the testing orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the facility.

It is estimated that a year will be needed for continued services while a new long-term contract BPA is being sought, evaluated, allow ample competition, and transition amongst reference laboratory contract holders.

Type of acquisition: Service

Expected dollar value of requirement: $784,163.03

Suggested 2022 NAICS code(s): 621511 – Medical Laboratories

Suggested 2022 PSC code: Q301 – Medical Laboratory Testing

Procurement History.

In accordance with FAR 7.102, contracting officers and acquisition planners are required to perform acquisition planning and conduct market research. The following information is a summary of the acquisition planning: In submitting this request for procurement, the customer considered available sources within the agency, any government furnished information/property, and security considerations IAW VA Directive/Handbook 6500. The contract type for this procurement is Firm Fixed Price FSS Task Order and the milestone schedule will be accomplished and documented in the Electronic Contract Management System (eCMS).

Effective Date: 03/01/2022 Page 10 of 14

ARUP Laboratories is the current contractor being used for reference laboratory testing for the Saginaw VA Medical Center. Testing will be for the patients of the participating facility.

The tests provided for the facility shall be varied and based on the facility needs and the testing orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the facility.

It is estimated that a year will be needed for continued services while a new long-term contract BPA is being sought, evaluated, allow ample competition, and transition amongst reference laboratory contract holders.

1. Was the requirement previously procured?

Saginaw - 36C25022F0196 ARUP Laboratories, Inc. $ 782,755.10 Saginaw – 36C25020F0471 ARUP Laboratories, Inc. $537,046.24

2. ARUP Laboratories is a large business.

3. There have been no changes in the marketplace since the previous procurement.

4. Is this a bundled (FAR 2.101) requirement? This is not a bundled requirement.

5. Are there any applicable Organizational Conflicts of Interest? There are no conflicts of interest.

II. Market Research

Techniques Used in Conducting Market Research:

Searches were conducted through SBA VetCert, SBA DSBS, and the GSA e-Library.

Results of Market Research:

A search was conducted in the SBA VetCert database using NACIS code 621511, which yielded 221 results.

A search was conducted in the SBA DSBS database for eligible SD/VOSB concerns using NACIS code 621511 and keywords “Reference Laboratory Testing” and services. There were zero (0) results.

While market research found 221 results through a search of the SBA VetCert database using NAICS code 621511, and 0 results through the search of the SBA DSBS database using NAICS code 621511 for SD/VOSB concerns using keywords “Reference Laboratory Testing, and services; none can provide immediate services as needed. The VA and SBA Rules of Two are not met.

A search was conducted in the SBA DSBS database for eligible SB concerns using NACIS code 621511 and keywords “Reference Laboratory Testing” and services. There were zero

(0) results.

A search was conducted in the GSA e-Library for laboratory testing services. Schedule 621 II was located. This schedule contains SINs 621-200 through 621-212.

Effective Date: 03/01/2022 Page 11 of 14

1. The VAMC requires a contractor that can provide testing within all SINs 621-200 to 621- 212.

2. A review by the CO located 3 large businesses that has the capability to provide testing in all required SINs:

a. ARUP Laboratories (ARUP), Contract 36F79720D0079, with a current expiration date of 3/31/2025.

b. Laboratory Corporation of America (LabCorp), Contract V797D-50532, with a current expiration date of 12/31/2026.

c. Quest Diagnostics (Quest), Contract V797D-70090, with a current expiration date of

3/31/2027.

III. Consideration of Small Business Opportunities

All acquisitions for supplies and services with an anticipated value above the micro-purchase up to and including the simplified acquisition threshold (SAT); these thresholds (see FAR 2.1-1 definitions) are reserved exclusively for small businesses and shall be set aside (FAR 19.502-2(a)). If the anticipated acquisition value exceeds the SAT, the requirement must be set aside for Small Businesses if (1) there is a reasonable expectation of receipt of offers from two or more responsible Small Businesses, and (2) award will be made at a fair market price (FAR 19.502-2(b)).

The VA’s contracting order of priority is set forth in VAAR 819.7004: Contracting officers shall consider, in the following order of priority, contracting preferences that ensure contracts will be awarded—

- To SDVOSBs

- To VOSB, including but not limited to SDVOSBs, To small business concerns using the priorities and preferences in 819.203-70 and VAAR subpart 819.70—

Note: The Small Business Jobs Act of 2010 created parity among small business socioeconomic contracting programs. As a result of this amendment to the Small Business Act, there is no order of precedence among the 8(a), HUBZone, SDVOSB or WOSB programs in FAR (see 819.203).

38 U.S.C. 8127 (i) Priority for Contracting Preferences. Provides that preferences for awarding contracts to small business concerns shall be applied in the following order of priority: (1) SDVSOBs, followed by (2) VOSBs, including SDVOSBs, then (3) 8(a) and HUBZone firms and (4) any other small business. The order of priority was established in 2006 by Public Law 109-461, as per the policy in the Small Business Act at that time. Since then, because of legislative amendments to the Small Business Act, the FAR has been amended to create a woman-owned small business set-aside and to provide parity among the various small business socio-economic programs. Therefore, VA has adopted the current parity policy in FAR 19.203 for procurements involving other than SDVOSBs/VOSBs.

Based on above Market Research, identify each Small Business (including its eligibility for specific socioeconomic category status) capable of performing or providing the requirement. Discuss and explain the potential for Small Business participation in this acquisition.

There are no SD/VOSB, or SB concerns found capable of providing the required testing.

Effective Date: 03/01/2022 Page 12 of 14

IV. Conclusions and Recommendations

A. Query of the SBA Veteran Small Business Certification (SBA VetCert) Database at Veteran Small Business Certification (sba.gov) resulted in:

Total of 221 small business concerns in each of the individual socio-economic group in 2022 NAICS 621511:

Identify the number and types of small businesses contacted: None.

Identify which if any of the small business has the necessary technical capability: None.

B. Query of the SBA Dynamic Small Business Search (DSBS) tool at

SBA - Dynamic Small Business Search), resulted in:

Total of 0 small business concerns in each of the individual socio-economic group:

C. For acquisitions above the SAT, describe considerations for a set-aside or sole source award under the following small business program set asides:

D. When a total small business set-aside seems appropriate, describe why a set-aside is not appropriate for:

While market research found 221 results through a search of the SBA VetCert database using NAICS code 621511, and 0 results through the search of the SBA DSBS database using NAICS code 621511 for SD/VOSB concerns using keywords “Reference Laboratory Testing, and services; none can provide immediate services as needed. The VA and SBA Rules of Two are not met.

A search was conducted in the SBA DSBS database for eligible SB concerns using NACIS code 621511 and keywords “Reference Laboratory Testing” and services. There were zero (0) results.

A search was conducted in the GSA e-Library for laboratory testing services. Schedule 621 II was located. This schedule contains SINs 621-200 through 621-212.

1. The VAMC requires a contractor that can provide testing within all SINs 621-200 to

621-212.

2. A review by the CO located 3 large businesses that has the capability to provide testing in all required SINs:

a. ARUP Laboratories (ARUP), Contract 36F79720D0079, with a current expiration date of 3/31/2025.

Effective Date: 03/01/2022 Page 13 of 14

b. Laboratory Corporation of America (LabCorp), Contract V797D-50532, with a current expiration date of 12/31/2026.

c. Quest Diagnostics (Quest), Contract V797D-70090, with a current expiration date of 3/31/2027.

ARUP Laboratories is the current contractor being used for reference laboratory testing for the Saginaw VA Medical Center. Testing will be for the patients of the participating facility. The tests provided for the facility shall be varied and based on the facility needs and the testing orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the facility.

It is required that the medical center has continuity of services for reference laboratory testing as not having these services could be detrimental to providing patient care.

Continuing a short-term contract with the current contractor will ensure no interruption of testing while the new long-term contract is being sought.

Three major companies are known provide reference laboratory services that have national contracts with the government. To continue to provide services, it is in the best interest of the Government to sole source a short-term contract to the current contractor.

The sole purpose of this limited source procurement request and resulting Task Order is not to circumvent competition but to provide for continuity of services while competition for the long-term VISN (multiple site) BPA is sought, competed, awarded, and implemented. In addition, it will allow the sites to seamlessly transition to the Cerner system without any interruptions to patient care.

The Lab Managers for the multiple sites are working together to develop a procurement package that encompasses the needs for each facility that includes the latest advancements in the current commercial markets. The new long-term VISN BPA will result in a base year plus four, one-year options and is estimated at approximately $24 Million. Based upon experience with the current VISN Reference Lab BPA and Veteran Health Indiana (VHI) Reference Lab BPA, it will take approximately 3-12 months to code and implement the new BPA if awarded to a new vendor. When laboratory services are obtained, a new list of tests need to be entered into the IT systems for the tests to correlate with the VAMCs and the vendor. It takes several months to build, test, and ensure there are no issues requesting tests.

As Cerner will not have to build these tests into the system, and the roll out of each site is different, it has been determined that all sites need to be on Cerner prior to implementing the new long-term request to avoid the risk of interruptions in patient care.

Having all sites on Cerner before the new long-term contract is implemented will provide a shorter implementation period as all major laboratories will have been built into Cerner.

There is not sufficient time to compete this requirement and have it awarded by the expiration of the current orders expiration date of 5/31/2023. While there are multiple vendors capable of performing the service for this interim contract, it is not in the best interest of the Government to compete this requirement. Competing this short-term requirement will cause a break in services which would impact direct patient care.

Effective Date: 03/01/2022 Page 14 of 14

Reference Lab services are a critical aspect to the medical centers. The new VISN Reference Lab BPA will consist of ten (10) locations across Indiana and Michigan.

IV. PROPOSED PROCUREMENT METHOD

Based on the market research conducted, no two or more SBA VetCert certified and capable SD/VOSBs were identified and appeared capable of performing the requirement. In addition, no small business in any of the other targeted socio-economic groups appeared to qualify for a set-aside or sole source procurement.

Therefore, it is anticipated that a sole source award will be made to ARUP Laboratories, a large business under the authority of FAR 8.405-6(a)(i)(B) Only One Source, through a Firm Fixed Price Task order. This market research information is not more than 12 months old.

Contracting Officer Network Contracting Office 10 Services Team 3

131687

Digitally signed by Sally L. Leitch 131687 Date: 2023.05.09 09:58:50 -04'00'

Veteran Small Business Certification

(VetCert)

Search Results Total Results

Search By NAICS Code

Name DBA Type SAM UEI DUNS Number

9Line LLC

Service Disabled Veteran Owned Small Business

T5HWQF3R8J93 830407016

A2A Integrated Logistics, Inc.

Service Disabled Veteran Owned Small Business

J54CPSYKKMV6 968913900

621511

Menu https://www.sba.gov/

Name DBA Type SAM UEI DUNS Number

A.B. Floyd Enterprises, LLC

Service Disabled Veteran Owned Small Business

NA35DMZL7BE7 107928192

Academy Medical Inc

Service Disabled Veteran Owned Small Business

HGEGAA2B93W9 190309067

Access International

LLC

Service Disabled Veteran Owned Small Business

VK8JB2SJCX51 080542144

Advance Solution Services, LLC

Service Disabled Veteran Owned Small Business

QQ16MVHGWUN5 118292095

ADV-SOC, Inc.

Service Disabled Veteran Owned Small Business

CHU3JKAC9NX8 078478586

AGAWZP LLC

Service Disabled Veteran Owned

G4RCA38K6CJ8

Small Business

Airborne Medical, LLC

Service Disabled Veteran Owned Small Business

LVRBAMZDW216 117210706

Alcyon Global

LLC

Service Disabled Veteran Owned Small Business

KMCMRLE3QWT1 117191498

Aldevra FSR

JV, LLC

Joint Venture Designation

DH9JD6JKQSH8 117359177

Aligned Employment Resources, LLC

Aligned Government Services

Service Disabled Veteran Owned Small Business

T7DVVUH9NND7 118048498

Alliant Enterprises, LLC

Alliant Healthcare Products

Service Disabled Veteran Owned Small Business

RM64EJ3CJ7Z5 121170653

Alpha Theta Center, Inc.

Veteran Owned Small Business

ZA71FWNJ6726 078872420

Alpine Conglomerate, LLC

Service Disabled Veteran Owned Small Business

HJJAJ8SJ1VJ4

American Lynx, LLC

Service Disabled Veteran Owned Small Business

EJFZAK6JAF39 080842857

American Veteran Contracting Solutions, LLC

Service Disabled Veteran Owned Small Business

KP3WZAS91F44 080866562

Ameriinfovets Inc

Service Disabled Veteran Owned Small Business

DR72K2SR8DS5 080529323

AMI Federal Services, Inc.

Service Disabled Veteran Owned Small Business

MJ7ARCS9Z6N7 118089976

ANI

Enterprises

LLC

Service Disabled Veteran

DMH1FFD87MG5 080990613

Business

Ansible Government Solutions, LLC

Service Disabled Veteran Owned Small Business

HJJHWA9KNKG7 079602477

Apache 61 Medical, LLC

Service Disabled Veteran Owned Small Business

YYEKWMRQCXH1

Appddiction Studio Limited Liability Company

Appddiction Studio LLC

Service Disabled Veteran Owned Small Business

WD4UD1FWVYL3 968907076

Arizona Natural Doctors, LLC

AZNDs Enterprises

Service Disabled Veteran Owned Small Business

EKFBTL36GE39 079209898

Aspire Therapy Services and Consultants, Inc.

Aspire Therapy Services

Service Disabled Veteran Owned Small Business

MFQAFE4L1B65 059417057

Auxo Medical, LLC

Veteran

WXA6JPF8KDQ9 806484333

Business

Avens Development Services, LLC

The Avens Group

Service Disabled Veteran Owned Small Business

ZXN1GF6FSLH9 080448646

# Name and Trade Name of Firm Contact E-mail Address In SAM? Address and City, State Zip Capabilities Narrative

DSBS is experiencing intermittent issues in displaying the most up-to-date certifications for some registrants. If a firm claiming certification does not appear as certified in DSBS, please contact answerdesk@sba.gov for assistance.

Search conducted on 3/29/2023 in SBA DSBS for SDVOSB and VOSB concerns, using NAICS code 621511, key words "Reference Laboratory Testing,", and checked Services.

TOTAL

$784,163.03

$784,163.03PROCUREMENT TOTAL:

BASIS FOR ESTIMATE AND ASSUMPTIONS

Estimates were determined by historical usage.

INDEPENDENT GOVERNMENT COST ESTIMATE

Procurement Name:

Requisition Number:

Saginaw VAMC & CBOCs Esot eric Testing

Requisition Number Goes Here

START HERE: Enter Procurement Data below.

FOR OFFICIAL USE ONLY

PROCUREMENT DATA

Contract Type: Procurement Type Goes Here

Contact Name:

Contact Number:

Darcy Cox - Developed 4/20/2023

SUBTOTAL:

Field Delegate: Field Delegate Name Goes Here (if used)

SUMMARY DATA

989-497-2500 extension 11604

Summary data, below, is autopulated from the yearly worksheets. Do not edit this section.

Period of Performance: 06/01/2023 - 5/31/2024

Test Code Test Name Vendor Saginaw Estimated

Saginaw Cost per Test

Saginaw Total Cost

2002434 (1,3)-Beta-D-Glucan (Fungitell (TM)) ARUP 6 119.69$ 718.14$ 0081335 1,5 Anhydroglucitol Quant, Serum/Plasma ARUP 1 50.53$ 50.53$ 2001766 S-100B Protein, Serum ARUP -$ 2008458 11-Deoxycorticosterone Quantitative by HPLC-MS/MS, Serum or Plasma ARUP -$ 0092331 11-Deoxycortisol Quantitative, Serum ARUP -$ 3000453 14-3-3 eta Protein ARUP -$ 3001255 14-3-3 Protein Tau, Total, CSF ARUP -$ 0092332 17-Hydroxyprogesterone Quantitative by HPLC-MS/MS, Serum or Plasma ARUP 2 20.93$ 41.86$ 0080650 17-Ketosteroids, Urine ARUP 2 27.37$ 54.74$ 70085 17-OH Progesterone LCMS LabCorp

481110 2019 Novel Coronavirus (COVID-19), NAA LabCorp

139945 2019 Novel Coronavirus (COVID-19), NAA using Saliva Collection LabCorp

3001962 21-Hydroxylase Autoantibodies, Serum ARUP -$ 504115 25-Hydroxyvitamin D LCMS D2+D3 LabCorp

2002348 25-Hydroxyvitamin D2 and D3, Serum ARUP -$ 0080235 5' Nucleotidase ARUP 8 12.92$ 103.36$ 2007228 5-FU Toxicity, Chemotherapeutic Response ARUP -$ 4069 5-HIAA,Quant.,24 Hr Urine LabCorp

3000202 5-Hydroxyindoleacetic acid (5-HIAA) ARUP -$ 0080420 5-Hydroxyindoleacetic Acid (HIAA), Urine ARUP 4 17.38$ 69.52$ 763824 763824 12+Oxycodone+Crt-Unbund LabCorp

SurePath88142A 88142 SurePath Pap Test ARUP -$ SurePath88142B 88142 SurePath Pap Test/Pathologist ARUP -$ ThinPrep88142A 88142 ThinPrep Pap Test ARUP -$ SurePath88143A 88143 SurePath Pap Test ARUP -$ SurePath88143B 88143 SurePath Pap Test/Pathologist ARUP -$ 2003418 A1 ACT by IHC ARUP -$ 0089006 A1A Phenotype Reflex Bill ARUP -$ 2011041 A1A ELISA, Random Stool ARUP -$ 0051256 A1A Genotype with Reflex to Phenotype ARUP -$ W,P,T-20061 AACT LabCorp

W,P,T-20061 AAT LabCorp

2003424 AAT by IHC ARUP -$

W,P,T-20051 AB-ALCIAN BLUE PH LabCorp

804389 Acanthamoeba + naegleria culture LabCorp

123231 ACE, CSF LabCorp

0090001 Acetaminophen Level ARUP 1 19.71$ 19.71$ 0080009 Acetylcholine Binding Ab ARUP 8 29.16$ 233.28$ 0099580 Acetylcholine Blocking Ab ARUP 1 32.22$ 32.22$ 0099521 Acetylcholine Modulating Ab ARUP -$ 2001571 Acetylcholine Receptor Ab Reflex Panel ARUP -$ 86007 Acetylcholine Receptor Ab, All LabCorp

2005639 ACHR Abs, Titin Ab, STM Abs Rflx Panel ARUP -$ 85902 AChR Binding Abs, Serum LabCorp

831464 ACHR Receptor Modulating Ab LabCorp

183753 Acid Fast Smear+Culture LabCorp

183764 Acid Fast Smear+Culture W/Rflx LabCorp

W,P,T-20061 ACTH LabCorp

0070031 ACTH Stimulating Cortisol 0 Min ARUP 4 10.16$ 40.64$ 0070032 ACTH Stimulating Cortisol 30 Min ARUP 4 10.16$ 40.64$ 0070033 ACTH Stimulating Cortisol 60 Min ARUP 4 10.16$ 40.64$ 4440 ACTH, Plasma LabCorp

W,P,T-20061 ACTIN (Muscle Specific) LabCorp

W,P,T-20061 ACTIN (Smooth Muscle) LabCorp

6643 Actin (Smooth Muscle) Antibody LabCorp

117762 Activated Protein C Resistance LabCorp

2011132 Acute Myeloid Leukemia Panel by FISH ARUP -$ 70228 Acylcarnitine Profile, Plasma LabCorp

0040033 Acylcarnitines Quantitative ARUP 1 113.25$ 113.25$ 2011248 Adalimumab Activity and Neutralizing Ab ARUP 6 363.68$ 2,182.08$ 2013605 Adalimumab Activity w/Rflx to Antibody ARUP 1 197.95$ 197.95$ 503890 Adalimumab Drug + Antibody LabCorp

504575 Adalimumab+Ab LabCorp

0030056 ADAMTS13 Activity ARUP -$ 117921 ADAMTS13 Activity Reflex Panel LabCorp

3000182 ADAMTS13 Antibody ARUP -$ 117925 ADAMTS13 Antibody LabCorp

117920 ADAMTS13 Antibody LabCorp

3000239 ADAMTS13 Reflex Panel ARUP -$ C90157 additional High Resolution ... LabCorp

3002982 Adenosine Deaminase in CSF ARUP -$ 3002980 Adenosine Deaminase in Peritoneal Fluid ARUP -$ 3002978 Adenosine Deaminase in Pleural Fluid ARUP -$ 830893 Adenosine…