36C25919Q0762-001.docx

Combined Synopsis/Solicitation for Commercial Items STAT Reference Lab Testing

General Information

Contracting Office Address Network Contracting Office 19 (NCO 19) Rocky Mountain Acquisition Center Department of Veterans Affairs 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 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 will not be issued.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-101_10-26-18.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1,000 Employees.

The NCO 19 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111 is seeking for procurement of automated instrumentation of immunohistochemistry (IHC) staining cost per slide lease, reagents for staining under a reagent usage rental agreement with service, training included, and any consumables necessary for testing.

All interested companies shall provide quotation for the following:

A. Scope of Work:

SCOPE: The Contractor(s) shall provide any laboratory tests properly authorized and requested to be performed by the contracted laboratory by a VA Montana clinician. The Contractor(s) shall provide same-day results for urgent testing (STAT) within the city limits of Miles City, Montana to support the VA Montana Outpatient in Miles City, Montana; and/or within the city limits of Billings, Montana to support VA Montana Outpatient clinic in Billings, Montana. Test results shall be within one hour from receipt of the sample or no later than two hours from the time of blood drawn. The Contractor(s) shall be approved to provide clinical diagnostic laboratory tests under both Medicare and Medicaid regulations and all applicable federal and state laws.

VA Montana Outpatient clinic in Miles City, Montana Contractor to furnish all management, supervision, and labor and select items of equipment and supplies necessary to perform Laboratory Services needed for patients seen at this Clinic. Services requested are itemized in Attachment A and include below requirements:

a. Testing of Laboratory samples as needed for emergent care decisions collected at the VA Montana Outpatient clinic in Miles City, Montana. Results forwarded to VA Montana Laboratory, Miles City, MT.

b. Emergent Arterial Blood Gas/Co-oximetry sample collection and testing (VA will send patient to testing laboratory location). Results forwarded to VA Montana Laboratory, Miles City, MT.

Laboratory results that fall on the VA Critical Value List supplied in ATTACHMENT B will be REQUIRED to be phoned in to the Miles City Outpatient Clinic Laboratory at 406-874-5666 or Community Living Center in Miles City, MT. at 406-874-5809. If unable to contact those sites, please phone critical value results to our Ft. Harrison Laboratory at 406-447-7512 (staffed 24/7).

Department of Veterans Affairs (VA) Healthcare Center in Billings, Montana Contractor to furnish all management, supervision and labor and select items of equipment and supplies necessary to perform Laboratory Services needed for patients seen at this Clinic. Services requested are itemized in Attachment A and include

a. Testing of Laboratory samples as needed for emergent care decisions collected at the VA Montana Outpatient clinic in Billings, Montana. Results forwarded to VA Montana Laboratory, Billings, MT.

b. Emergent Arterial Blood Gas/Co-oximetry sample collection and testing. Results forwarded to VA Montana Laboratory, Billings, MT.

Laboratory results that fall on the VA Critical Value List supplied in ATTACHMENT B will be REQUIRED to be phoned in to the Billings VA Laboratory at 406-373-3900. If unable to contact the lab, please phone critical value results to our Ft. Harrison Laboratory at 406-447-7512 (staffed 24/7).

ATTACHEMENT B: LABORATORY CRITICAL VALUES INCLUSIVE RANGES

VA Healthcare Montana Microbiology Critical Values

ANY POSITIVE CSF GRAM STAIN OR CULTURE

INSTRUMENT POSITIVE BLOOD CULTURE GRAM STAIN

ANY EYE CULTURE WITH GRAM NEGATIVE ROD/GRAM POSITIVE ROD ON GRAM STAIN OR ISOLATED IN CULTURE

GRAM NEGATIVE OR GRAM POSITIVE ORGANISMS NOTED ON GRAM STAIN OF BLOOD UNIT (FFP, PLT OR RBC’S) IMPLICATED IN TRANSFUSION REACTION

MULTI-DRUG RESISTANT ORGANISMS INCLUDING BUT NOT LIMITED TO; MRSA, VRE, EXTENDED SPECTRUM BETA-LACTAMASE AND CARBAPENEMASE PRODUCING GRAM NEGATIVE RODS.

C.DIFFICILE COMMON ANTIGEN AND TOXIN POSITIVE BY EIA OR PCR

POSITIVE AFB SMEAR OR M. TUBERCULOSIS ISOLATED FROM CULTURE

SELECT AGENT ORGANISMS INCLUDING BUT NOT LIMITED TO; YERSINIA PESTIS, FRANCISELLA SP., BURKHOLDARIA SP., BACILLUS ANTHRACIS

PATIENT SENSITIVE DATA:

The Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA) and the Department of Defense (DoD). The VA has recognized that Diagnostic Laboratory Testing Facilities are Health Care Providers and the PHI is being disclosed and/or used for treatment of an individual, and are entities that do not require a Business Associates Agreement (BAA) with their contractors as long as they are conducting health care on behalf of the VA.

Contractor is considered to be a Government Provider for purposes of the Privacy Act of 1974. The treatment and administrative patient records created by, or provided to, the Contractor under this agreement is covered by the VA system of records entitled “Patient Medical Records-VA” (24VA136). Medical records shall be secure, complete, legible, accurate, accessible, organized and maintained in a format that facilitates retrieval of information. Information from VA medical records requested by the patient or any other third party shall be referred to Health Information Services (HIMS) at CAVHS in accordance with Privacy Act of 1974, Title 38 of United States Code (U.S.C.) (U.S.C 5701, 5705 and 7332), as well as other Federal law, embodied elsewhere in the U.S. Code that bear directly on the privacy of personal data. The Contractor is restricted from making disclosures of Government records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from the Government has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as the Government.

Place of Performance Department of Veterans Affairs (VA) Healthcare Center in Billings, MT

VA Montana Outpatient Clinic in Miles City

This solicitation is for multiple awarded Blanket Purchase Agreement (BPA). Award(s) shall be made to the quoter(s) whose quotation offers the best value to the Government, considering technical capability, past performance, and price. The Government will evaluate information based on the following evaluation criteria: (1) technical capability factor "meeting or exceeding the requirement” and (2) price. Past performance will be reviewed for responsibility determination.

Factor 1: Technical capability. a) Provide evidence of a current Clinical Laboratory Improvement Act (CLIA) license issued by CMS accrediting your laboratory performing the STAT reference laboratory test. b) Show that your laboratory site is within 8 miles radius of 1766 Majestic Lane, Billings, MT or 201 S. Winchester Ave., Miles City, MT.

Factor 2: Price. Complete Price List. Prices will be reviewed for reasonableness.

Past Performance: Send Past Performance Questionnaire attachment to previous customers to complete and email directly to Bai.Perney@va.gov.

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” (Oct 2018)

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (Oct 2018)

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal 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 52.204-9, “Personal Identity Verification of Contractor Personnel” (Jan 2011)

· FAR 52.203-99 Prohibition on Contracting with Entities That Require Certain Internal Confidentiality Agreements (Deviation) (Feb 2015)

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (Oct 2018)

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (Oct 2019)

The following subparagraphs of FAR 52.212-5 are applicable:

Subparagraph (b)(1), (b)(2), (b)(4), (b)(6), (b)(7), (b)(8), (b)(9), (b)(25), (b)(27), (b)(28), (b)(29), (b)(30),(b)(31), (b)(32), (b)(33), (b)(34), (b)(35), (b)(42), (b)(48), (b)(54), (b)(57), (c)(1), (c)(2), (c)(4), (c)(8).

· 52.217-8, “Option to Extend Services” (Nov 1999)

· 52.222-54, “Employment Eligibility Verification” (Oct 2015)

· FAR 52.224-1, “Privacy Act Notification” (Apr 1984)

· FAR 52.224-2, “Privacy Act” (Apr 1984)

· FAR 52.228-5, “Insurance – Work on a Government Installation” (Jan 1997)

· FAR 52.232-19, “Availability of Funds for the Next Fiscal Year” (Apr 1984)

· FAR 52.237-3, “Continuity of Services” (Jan 1991)

· VAAR 852.203-70, “Commercial Advertising” (Jan 2008)

· VAAR 852.215-71, “Evaluation Factor Commitments” (Dec 2009)

· VAAR 852.203-70, “Commercial Advertising” (Jan 2008)

· VAAR 852.219-10, “VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside” (Jul 2016) (Deviation)

· VAAR 852.232-72, “Electronic Submission of Payment Requests” (Nov 2012)

· VAAR 852.237-7, “Indemnification and Medical Liability Insurance” (Jan 2008)

· VAAR 852.237-70, “Contactor Responsibilities” (Apr 1984)

· VAAR 852.271-70, “Nondiscrimination in Services Provided to Beneficiaries” (Jan 2008)

This is an open-market combined synopsis/solicitation for products as defined herein. The Government intends to award a Blanket Purchase Agreement (BPA) 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).

Instruction to Quoters:

(1) Submission shall be received not later than October 15 at 2:00 PM Mountain Standard Time (MST) to Bai.Perney@va.gov . All submission shall be 5MB or less. If the email is going to be more than 5MB, then please submit in multiple emails labeling 1 of XX, 2 of XX, etc. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

(2) Questions shall be submitted in writing via email no later than October 8, 2019 by 1:00 PM, MST to Bai Perney, Bai.Perney@va.gov.

(3) Quoters may choose to propose on one or both locations. Quoters are also encouraged to submit a separate specialty STAT testing menu and prices that are not listed in the Price list.

(4) Attached Wage Determinations for Custer County and Yellowstone County: WDOL 2015-5390 rev.9 9-16-2019 and WDOL 2015-5396 rev.10 9-16-2019

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 1 of 4 Original Date: 10/12/17 Revision 01 Date: 01/08/18