Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 21, 2022 SAM #7538
SOLICITATION NOTICE

Q -- Prolaris Testing

Notice Date

7/19/2022 12:30:16 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

262-NETWORK CONTRACT OFFICE 22 (36C262) Gilbert AZ 85297 USA
 

ZIP Code

85297
 

Solicitation Number

36C26222Q1306
 

Response Due

7/29/2022 1:00:00 PM
 

Archive Date

09/27/2022
 

Point of Contact

Domen, Clift, Contract Specialist, Phone: 562-766-2241
 

E-Mail Address

Clift.Domen@va.gov
(Clift.Domen@va.gov)
 

Awardee

null
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 -- Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR -- Part 13 Simplified Acquisition Procedures; and supplemented with additional information included in this notice. This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular 2022-06, dated May 26th, 2022. Solicitation 36C26222Q1306 is issued as a Request for Quote (RFQ) and constitutes the only solicitation. The Government intends to award a single Firm-Fixed Price (FFP) award contract. This procurement will be issued under Full and Open Competition. NAICS Code is 621511 and the Small Business Administration s (SBA) size standard is $35.0 Million. The Government is seeking a contract to acquire Prolaris testing. This solicitation is seeking to fulfill the following statement of work: Period of Performance: 09/01/2022 08/31/2023 (on an as needed basis) STATEMENT OF WORK (SOW) Background The VA Long Beach Healthcare System (VALBHCS) providers preferred the VA Long Beach Pathology & Laboratory Medicine Service (PALMS) to use Prolaris to test for patient with cancer diagnostics. Prolaris is a molecular diagnostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris can be used in conjunction with other clinical parameters to determine prostate cancer aggressiveness. Scope The contractor shall perform services for the VALBHCS PALMS. The contracted reference laboratory (Contractor) shall process the slides and/or perform analytical testing as defined by the Contractor's reference test manual, report analytical test results, and provide consultation services as required. All terms, conditions and requirements defined herein shall apply to any laboratory (i.e., branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor. The Prolaris® test combines existing clinicopathologic features (Gleason, PSA, Stage, % Positive, age) with a quantitative PCR analysis to measure the mRNA expression levels of 31 cell cycle progression genes and 15 control genes to measure tumor aggressiveness independent of but in addition to pathologic characteristics at the fixed time of biopsy. The VALBHCS is located at: VA Long Beach Healthcare System (VALBHS) Pathology & Laboratory Medicine Service 5901 E. 7th Street Long Beach, CA 90822 Specific Test Requirements qRT-PCR technology Gold Standard Assay TaqMan Cared using Applied Biosystems 7900HT Fast Real-Time 46 Gene RNA-expression tests (31 CCP Gene Expression measured against 15 normal genes) Sample Requirements Sample: Prostate Needle Biopsy Selection of tissue sample: The core with the greatest length of continuous tumor should be chosen. Require 0.5 mm tumor length with 70% tumor density. Can be from formalin fixed tissue blocks or 6 formalin fixed unstained consecutive sections on uncharged slides plus one H&E slide. If the block cannot be sent, requires one slide for an H&E cut at 4 - 5 microns, plus, a minimum of 20 microns of unstained tissue, cut consecutively. Deliverables Shipping: Prefilled FedEx Priority label affixed to Packaging required for sample transportation Turnaround Time: 7 14 days Delivery of clinical grade patient reports and data return to the VA in structured formats via secure file transfer mechanisms. Patient Facing Visual Diagram with QR Code for interactive report tutorial Provider Facing Risk stratification diagrams included comparison to NCCN groups and validated treatment thresholds. Provider QR code for interpretation of clinical diagrams and details included Disease Specific Mortality when untreated and Risk of Metastasis when treated calculation from Prolaris Cell-cycle Risk score CCR algorithm Separation of clinical and pathologic indications from Prolaris Cell Cycle Proliferation score CCP Additional Options: Faxed, Mailed, Sent to Secure Portal and other custom options based on preference in any data type. Standard Delivery Time: Estimated at 14 days from each Order Date Licensures Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall be licensed/accredited by the College of American Pathologists (CAP), the Nuclear Regulatory Commission, Center for Disease Control, Medicare and other state regulatory agencies as mandated by Federal and State statutes. In addition, the laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and shall comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA). Contractor copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America are required. In addition, as these documents are reissued or reworded, the awarded Contractor shall supply a copy to the Contracting Officer. This documentation shall also be supplied for each reference laboratory that is a subcontractor of the primary Contractor. The Contractor shall ensure that each facility is in compliance with the College of American Pathologists (CAP) standards, Clinical Laboratory Improvement Amendments (CLIA) standards, and VHA Directive 1106 and VHA Handbook 1106.01, Attachments B and C respectively. Additional Requirement Specifications Performance Monitoring The Contractor shall furnish a monthly exception report and turn-around-times will be monitored as part of VA quality assurance plan. Security Requirements The Contractor shall be responsible for the security and integrity of specimens and for compliance with all Health Insurance Portability and Accountability Act (HIPAA) requirements. The Contractor shall also be responsible for ensuring the proper credentialing of its employees who interact with personnel. Additionally, the Contractor shall adhere to all Information Technology Security requirements as set forth in VA Handbook 6500.6, Attachment D, and shall adhere to Appendix C and Appendix D and submit proper documentation as required. The reference laboratory shall assume full liability for the samples and data at the time of receipt. The Contractor shall use reasonable and appropriate safeguards to prevent use or disclosure of protected health information (PHI) not provided for by this solicitation. Within 24 hours of the Contractor becoming aware of a HIPAA violation involving electronic transactions, paper labels and code sets, privacy, security or standard identifier, or disclosure of PHI not provided for by this solicitation, the Contractor shall report violations to the proper authorities identified in VA Handbook 6500.6. The C&A requirements do not apply and that a Security Accreditation Package is not required. Third Party contract terms and provisions The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. All VA policies shall be followed and the contractor shall not copy, expose, and share information of Protected Health Information documents. Hours of Operation Normal tour-of-duty hours at VA Healthcare Centers is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day Last Monday in January Memorial Day Last Monday in January Juneteenth Third Monday in June Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies. Invoicing. The Contractor shall submit a monthly invoice for services rendered no later than 21 days following the close of the month in which the test result was reported. The invoice shall be checked for accuracy and shall display chronologically by date of Contractor receipt the name of the patient, the date of specimen collection by the Contractor, details of the test performed on each patient, and the unit and total testing costs. The Contractor shall not charge for repetitive testing performed on a specimen to verify questionable initial results. Use obligation number for payment processing. All invoices must be submitted via Tungsten at: https://portal.tungsten-network.com/Login.aspx?ReturnUrl=%2f The information identified above is intended to be descriptive, not restrictive and to indicate the quality that will be satisfactory. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can provide the services being requested. Provisions 52.212-1, Instructions to Offerors Commercial and 52.212-2, Evaluation Commercial Items are applicable to this acquisition. Furthermore, Provision 52.212-2 is utilizing the lowest price on an Acceptable/Unacceptable evaluation process. Submitting Quote: Offeror(s) shall submit their quote via email on company letterhead and shall include the completed pricing forms, along with name, address, telephone number of the offeror, firm s UEI#, total price and a completed copy of FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items or a copy of offeror s annual offeror representations and certifications (ORCA) document from www.sam.gov as required by FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items. Submit all question(s) to Clift Domen at clift.domen@va.gov no later than Thursday July 21st, 2022, and before 1:00 PM Pacific Daylight Time (PDT). Ensure to reference solicitation # 36C26222Q1306 within the subject line of the email. Quotes must be received by Friday, July 29th, 2022, and before 1:00 PM PDT. Email your quote to Clift Domen at clift.domen@va.gov. Ensure to reference solicitation # 36C26222Q1306 within subject line of the email. Quote(s)/offer(s) received after the prescribed deadline, shall be considered non-responsive and will not be considered for award. CONTRACT CLAUSES AND PROVISIONS 52.212-2 - Evaluation Commercial Items (Nov 2021) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical acceptability shall be established by review of each submitted quote, attachments, and/or information by the designated technical evaluator/s and verification that any brand name or equal to items"" meet all the salient characteristics included in this solicitation. No other rating or quantitative value other than acceptable or unacceptable will be assigned. Once technical acceptability has been established, the Contracting Officer shall award to the lowest price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of clause) 52.217-6 - Option for Increased Quantity (Mar 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. (End of clause) 52.217-8 - Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days of contract expiration. (End of clause) 52.252-2 - Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses and provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ FAR 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Nov 2021) FAR 52.212-4, Contract Terms and Conditions -- Commercial Items (Nov 2021) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2022) FAR 52.232-18, Availability of Funds (Apr 1984) FAR 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Nov 2021) FAR 52.233-1, Disputes (May 2014) VAAR 852.203-70, Commercial Advertising (May 2018) VAAR 852.232-72, Electronic Submission of Payments (Nov 2018) (End of Clause) 52.252-1 - Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html https://www.acquisition.gov/vaar FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.209-7, Information Regarding Responsibility Matters (Oct 2018) FAR 52.233-2, Service of Protest (Sep 2006) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (Oct 2018) VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (Jan 2008) (End of Provision)
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/1c9d650995ed4f5ead4d25cb8d4f7ee5/view)
 

Place of Performance

Address: VA Long Beach Healthcare System 5901 East 7th Street, Long Beach 90822, USA

Zip Code: 90822

Country: USA
 

Record

SN06393689-F 20220721/220719230053 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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