Combined Sysnobis solicitation.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a written solicitation will not be issued. The Request for Quote number is HT940624R0030. Offers are due not later than 10:00 A.M. EST on 21 June 2024. Provisions and clauses in effect through Federal Acquisition Circular 2024-05 are incorporated. NAICS code for this acquisition is 334516. Small Business size standard is 1,000 employees. The Defense Health Agency will award a cost per test purchase order, for two (2) integrated chemistry Analyzers on behalf of the 633rd Medical Group, Langley AFB, VA. resulting from this synopsis/solicitation to the responsible contractor whose quote conforming to the solicitation will be more advantageous to the Government, price and other factors considered.

The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also apply to this acquisition. The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition.

Regulatory Requirements:

The analyzer and all of its components shall be approved by the Food and Drug Administration (FDA) to market and deliver medical products for use in the United States of America. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America.

Essential Characteristics: The integrated chemistry used to analyze serum plasma, urine, CSF or other body fluids for quantitative analysis of various chemistry analytes. The system must include a water system, integrates with current LIS system, QC lockout, automated QC, Calibrations and dilutions, no sample carryover, sample management, 24hr operational, positive patient identification and on-board storage for reagents.

· Analyzers shall be an integrated chemistry system.

· Analyzers shall have an approved ATO.

· Analyzers and assays shall be FDA approved. The assay, instrumentation or the company cannot have FDA warning letters issued over the past 24 months.

· Each Analyzer shall fit in space of: Height 5.8 ft, Depth 2.6 ft, and Width 8.04f.t

· Instruments should interface with the laboratory Genesis laboratory information management system (LIMS).

· Process sample volumes of 20 uL or less for chemistry and 35 uL for immunoassays.

· System must include middleware.

· System must be capable of utilizing sample tube bar codes for accurate sample identification.

· System must be capable of processing and testing at least the following tube sizes 13x75mm, 16x75mm and 16x100mm.

· The system shall be capable of external data storage in compliance with Department of Defense (DoD)/Defense Health Agency (DHA) Information Assurance (IA) regulations.

· High analytical sensitivity.

· Analyzers can process cardiac assays, basic metabolic panels and HCG under 15 minutes.

· Daily hands-on maintenance less than 20 minutes.

· Onboard stability greater than 3 months

· Instrument must be capable of fully automated dilutions.

· Testing system must have minimal hand-on maintenance.

· Instrument must offer up to 24 hours walkaway time.

· Instruments must have the capability to store controls and calibrators on-board and allow continuous access to reagents, calibrators, controls, and consumables.

· Reagents and calibrators must be liquid ready to use directly from storage.

· Testing system must have auto-calibration.

· Instrument must have QC lockout.

· Analyzers must have automated QC.

· Instrument must be capable of fully automated quality controls and calibrations.

· Instrument must offer up to 24 hours walkaway time

· Instrument must always be in the “ready” mode and at no time go into hibernation or

“sleep” mode

· System shall be capable of processing STAT request in at most 30 minutes.

· The system shall be able to complete STAT testing results for troponin, BHCG quantitative and CMP with a turnaround time of at most 15 minutes.

· The system must be capable of utilizing sample tube bare codes for accurate sample identification.

· The system shall be capable of processing and testing at least the following tube sizes: 13x75mm, 13x100mm,16X75mm, and 16x100mm.

· The minimum 8mm microtainers shall be processed and tested on the platform.

· The system shall be able to perform auto-dilutions.

· Each analyzer shall be capable of at least 850 tests per hour, to maintain current workflow.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

See attached Statement of Work

FAR 52.212-2 - EVALUATION - COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) applies to this acquisition.

(a) The Government will award a contract resulting from this solicitation to the responsible vendor whose offer conforming to the solicitation will be most advantageous to the Government. Factors others than price shall be considered, and a Price/Technical Tradeoff analysis of both price and non-price factors will be conducted in evaluating each quote submitted. Trade-off considerations may result in the determination that it is in the best interest of the Government to award to other than the lowest priced Vendor or other than the highest technically rated Vendor. The following factors shall be used to evaluate offers:

Technical offers must include sufficiently detailed information to enable evaluation based on the three (3) factors listed below in order of decreasing priority:

Evaluation Factors:

Volume I: Technical Approach Proposal

Evaluation Factor A: Essential Characteristics

Evaluation Factor B: FDA Approval/Authorization Documentation

Volume II: Past Performance Proposal

Evaluation Factor C: Past Performance Confidence Assessment

Volume III: Business Proposal

Evaluation Factor D: Price

Evaluation Factor E: Offer, Amendments, and Certifications & Representations

Volume IV: Small Business Plan

Evaluation Factor F: Small Business Sub-Contracting Plans (FAR 52.219-9)

1. Volume I: Technical Approach Proposal

1.1 Evaluation Factor A: Minimum Requirements and Enhancing Factors documentation of compliance with Statement of Work (SOW) Sections 1.0 shall be provided with the offeror’s proposal. Compliance with essential characteristics.

1.1. Rating Scale for Evaluation Factor A: Minimum Requirements and Enhancing Factors

Rating Description

Pass Meets essential characteristics.

Fail Does not meet essential characteristics.

1.2 Rating Scale for Evaluation Factor B: FDA Approval/Authorization

Rating Description

Pass Provided FDA approval/authorization documentation and Provided copy of current FDA approval to market and deliver medical products for use in the United States of America ________________________________________________________________________________

Fail Offeror does not have FDA approval/authorization to market and deliver medical products for use in the United States of America or failed to Include documentation required in section 1 of the statement of work.

complete, accurate, and verifiable information as listed in section 1.2 of the evaluation factors.

2. Volume II: Past Performance Proposal

2.1. Evaluation Factor C - Past Performance. The Past Performance evaluation is a three-step process. The offeror’s Past Performance volume will be evaluated to determine recency, relevancy, and a confidence assessment. The evaluation of relevant past performance will result in a single, overall confidence assessment of the offeror’s probability of meeting the solicitation requirements.

2.2. The Government will first evaluate each past performance reference submitted to assess if it is recent.

Rating Scale for Evaluation Factor C: Recency

Rating

Description

Recent Past performance information that is within five years of the closing date of the solicitation is considered recent.

Not Recent Past performance information that is older than five years of the closing date of the solicitation is considered not recent.

2.3. The Government will then evaluate recent past performance for Relevancy or how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection.

Rating Scale for Evaluation Factor C: Relevancy

Relevant Past performance information that is for immunoassay reagents provided in a volume/dollar value similar to that required by this solicitation.

Not Relevant Past performance information that is not for immunoassay reagents provided in a volume/dollar value similar to that required by this solicitation.

2.4. The Government will further evaluate recent, relevant past performance references to establish an overall past performance confidence assessment. The confidence assessment will consider items such as but not limited to: quality (total number of rejected or returned reagents, with reasons for rejection or return, and total number of kits replaced) and responsiveness (offeror’s compliance with established delivery schedules and ability to provide timely replacement reagents due to recall or return.) The Government reserves the right to utilize other information not provided by the offeror and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contact are verified and accurate. A Substantial Confidence and a Satisfactory Confidence assessment will be evaluated as a higher rating than a Neutral Confidence assessment rating.

Rating Scale for Evaluation Factor C: Confidence Assessment

Substantial Confidence Based on the offeror’s recent/relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.

Satisfactory Confidence Based on the offeror’s recent/relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort.

Limited Confidence Based on the offeror’s recent/relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.

No Confidence Based on the offeror’s recent/relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.

Unknown Confidence (Neutral) No recent/relevant performance record is available, or the offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.

3. Volume III: Business Proposal

The Government will conduct a price analysis in accordance with FAR 13.106-3. Adequate price competition is expected to support the determination of reasonableness. Price analysis techniques may be utilized to further validate price reasonableness.

Evaluation of price will be based on the offeror’s total price for all line items as delivered to Hampton, VA.

Offer, Amendments, and Certifications & Representations: The Government will review the proposal to see if the offeror completed FAR 52.212-3 Offeror Representations and Certifications-Commercial Items. The Government will check SAM.gov to make sure the vendor is registered in SAM.gov. By the offeror maintaining an active entity registration in SAM, the entity complied with requirements to report proceedings data in accordance with FAR 52.209-7 Information Regarding Responsibility Matters and with requirements to report executive compensation data in accordance with FAR 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards.

Rating Scale for Evaluation Factor F: Offer, Amendments, and Certifications & Representations

Rating Description

Pass Offeror is active in SAM.gov at time of submitting proposal and completed FAR 52.212-3

Fail Offeror is not active in SAM.gov at time of submitting proposal and/or failed to complete FAR 52.212-3.

The Government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided above. The Government is likely to randomly select references provided for contact and does not commit to contact every reference.

4. Volume IV: Small Business Plan

4.1. . Small Business Sub-Contracting Plans (FAR 52.219-9) will be reviewed to determine adequacy of the extent of participation a small businesses will be utilized under a resultant contract, whether as a joint venture, teaming partner, or subcontractor as required by FAR 19.705-4. The small business goal is 5%. Master subcontracting plans can be included as an attachment to the subcontracting plan. If the offeror believes there are no subcontracting possibilities, the offeror shall submit documentation sufficient to support its position. If the offeror believes there are no subcontracting possibilities, the offeror shall submit documentation sufficient to support its position.

The Government will review the extent to which the Offeror complied with FAR 52.219-8 – Small Business utilization and FAR 52.219-9 – Small Business Subcontracting Plan (if applicable). In order to be considered for an award the offeror shall submit a Small Business Sub-Contracting Plans (FAR 52.219-9) or a sufficient explanation supporting the offeror’s position as described above.

a. The extent to which the Offeror complied with FAR 52.219-8 – Small Business Utilization will be evaluated based on the following:

i. Reporting of small business performance in the Contractor Performance assessment Reporting System (CPARS).

ii. History of prompt payment to small businesses

iii. Small business participation/utilization reporting

b. The extent to which the Offeror complied with FAR 52.219-9 – Small Business Subcontracting Plan will be evaluated based on the following:

i. Achievement of Subcontracting goals

ii. Compliance with subcontracting plan requirements

iii. eSRS reporting

INSTRUCTIONS TO OFFEROR

Offerors must submit an offer that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Offers shall be in the form prescribed by, and shall contain a response to, each of the areas identified. Any offer which does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration. A complete offer including Technical, and Price, shall be submitted by the closing date specified in the solicitation.

TECHNICAL OFFER INSTRUCTIONS

Offerors shall provide sufficient technical documentation to allow for thorough evaluation of offer. Additionally, the vendor shall fully explain their ability to meet the requirements.

Page limit for technical offer: 30 pages

PRICE OFFER INSTRUCTIONS

Offeror shall specify the Total Price. Shipping shall be FOB destination. Offers will be evaluated to ensure reasonableness and completeness. The government anticipates award of a Firm Fixed Price contract. Offerors shall submit firm-fixed pricing for all above requirements. Include commercial price lists and if applicable, any FSS schedule numbers and pricing. Include any applicable discounts to the Government.

Page Limit for pricing offer: 5 pages

Other Administrative instructions:

The vendor shall provide company details, specifically:

Complete company name and address:

e-mail address:

Phone Number:

Estimated number of days to deliver after award received:

Current and valid Tax Identification Number (TIN):

Current and valid CAGE Code:

Current and valid Unique Entity ID:

Submission of Offer

Only email offers will be accepted. (Email can be no larger than 5 Megs, multiple emails will be accepted) Email offer proposal as attachment to Jan Harding at jan.t.harding.civ@health.mil. No paper proposals will be accepted. offers are due not later than 10:00A.M. Eastern on 21 June 2024. Any questions must be addressed to Jan Harding, by email only, NLT 10:00 AM Eastern on 13 June 2024. No phone calls accepted.

The following FAR provisions and clauses are applicable to this procurement:

52.212-1 Instructions to Offerors-Commercial Products and Commercial Services.

2023-09

52.212-2

Evaluation-Commercial Products and Commercial Services

2021-11

52.212-3

Offeror Representations and Certifications-Commercial Products and

Commercial Services

2023-11

52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services.

2023-11

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items

2024-02 52.204-7 System for Award Management.

2018-10

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities 2023-12

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

2015-11 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

2018-10

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment.

2015-10

52.219-6

Notice of Total Small Business Set Aside

2020-11

52.222-3

Convict Labor

2003-06 52.222-19 Child Labor-Cooperation with Authorities and Remedies

2018-12 52.222-21 Prohibition of Segregated Facilities

2015-04 52.222-26 Equal Opportunity

2016-09 52.222-35 Equal Opportunity for Veterans

2020-06 52.222-36 Equal Opportunity for Workers with Disabilities

52.222-37 Employment Reports on Veterans

52.222-40 Notification of Employee Rights Under the National Labor Relations Act

2010-12

52.222-50 Combating Trafficking in Persons

2021-11 52.223-11 Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons

2016-06 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving 2020-06 52.239-1

Privacy or Security Safeguards

1996-08 The following DFAR provisions and clauses are applicable to this procurement:

252.203-7000 Requirements Relating to Compensation of Former DoD Officials.

2011-09

252.203-7002 Requirement to Inform Employees of Whistleblower Rights.

2022-12

252.203-7005 Representation Relating to Compensation of Former DoD Officials.

2022-09

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support.

2023-01

252.204-7016 Covered Defense Telecommunications Equipment or

Services- Representation.

2019-12

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications

Equipment or Services-Representation.

2021-05

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications

Equipment or Services.

2023-01

252.204-7024 Notice on the Use of the Supplier Performance Risk System.

2023-03

252.211-7008 Use of Government-Assigned Serial Numbers.

2010-09

252.211-7003 Item Unique Identification and Valuation.

252.223-7008 Prohibition of Hexavalent Chromium.

252.225-7000 Buy American--Balance of Payments Program Certificate.

2014-11

252.225-7001 Buy American and Balance of Payments Program.

252.225-7002 Qualifying Country Sources as Subcontractors.

2022-03

252.225-7012 Preference for Certain Domestic Commodities.

2022-04

252.225-7031 Secondary Arab Boycott of Israel.

2005-06

252.225-7050 Disclosure of Ownership or Control by the Government of a Country that is a State Sponsor of Terrorism.

2022-12

252.225-7055 Representation Regarding Business Operations with the Maduro Regime. 2022-05

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime.

2023-01

252.225-7059 Prohibition

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur

Autonomous Region.

2023-06

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports.

2018-12

252.232-7006 Wide Area Workflow Payment Instructions

2023 -01

252.232-7010 Levies on Contract Payments.

2006-12

252.244-7000 Subcontracts for Commercial Products or Commercial Services.

2023-11

252.246-7008 Sources of Electronic Parts.