52_212-1_Addendum_INSTRUCTIONS_TO_OFFERORS__COMMERCIAL_ITEMS.doc

ADDENDUM 1 to FAR 52.212-1 – INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS

In addition to requirement of 52.212-1(b)(4) the offeror shall submit the following additional technical information:

BASIS FOR CONTRACT AWARD: Two factors will be used to evaluate offerors’ quotes: Technical Acceptability and Price. Contract award will be made to the offeror who submits the lowest total evaluated price quote achieving a rating of “Acceptable” for both subfactors under the Technical Acceptability factor. By submission of its offer, the offeror accedes to all solicitation requirements including: terms and conditions, representations and certifications, technical requirements, and the evaluation factors and subfactors contained herein. Failure to meet a requirement may result in an offer being determined unacceptable for award. The offeror must clearly identify any exception to the solicitation terms and conditions with accompanying rationale. The evaluation shall proceed as follows:

1.

Technical Acceptability – The Government technical evaluation team shall evaluate the technical quotes at the subfactor level, assigning an “Acceptable” or “Unacceptable” rating as defined below.

Acceptable – The proposal clearly meets the minimum requirements of the solicitation.

Unacceptable – The proposal does not clearly meet the minimum requirements of the solicitation.

(a) Subfactor 1 – Product Specifications – The measures of merit are met when the offeror:

i. The Contractor shall demonstrate and describe how you will meet the specifications listed below (PWS Section 1.1-1.16)

1.1. New (not previously owned) Food & Drug Administration (FDA)-approved analyzer(s) and components, with auto-loading feature.

1.2. Must be a discrete analyzer, capable of performing at least 150 patient tests/(hr)

1.3. Capable of processing adult and pediatric (micro-sample) specimen collection tubes.

1.4. For applicable tests, must meet performance requirements for federally regulated analytes.

1.5. Must include some “walk away” maintenance procedure capabilities, allowing for after-hours scheduling of maintenance tasks.

1.6. Must have on-board tracking of reagent, controls, calibrators, and ancillary reagents.

1.7. Included reagents/ancillaries are primarily ready-to-use, with minimal technician preparation required.

1.8. Provide reagents with stability through estimated usage (i.e., minimal reagent waste due to expiration).

1.9. Calibration material is provided for each assay.

1.10. Must have capabilities for user-defined test parameters.

1.11. Contractor shall only offer items which already have an Authorization to Operate (ATO), or items for which the contractor agrees to go through the DoD Information Assurance (IA) approval process and obtain a Risk Management Framework (RMF) ATO. A completed Joint Medical Device Risk Assessment Questionnaire (DRAQ), v1.1, for the offered system must be provided with proposal. All equipment and software supplied at initial and subsequent installations will accurately reflect responses provided on DRAQ.

1.12. The system must have barcode/data reading capabilities.

1.13. The system must have proven interface capabilities with Composite Health Care System (CHCS).

1.14. System must possess software capable of multitasking, i.e., allows technicians to perform data operations simultaneously with analyzer operations.

1.15. Must be capable of loading reagents while system is operational (stand-by not required to load).

1.16. If instrument-feed water is required for operation of the Chemistry system, must provide water purification system and applicable maintenance, supplies, and services.

2.

Price Evaluation – The Government will evaluate the offeror’s price quote, to include all options, for price completeness and reasonableness as described below.

(a) Completeness – The offeror’s price quote will be evaluated for completeness by confirming the offeror has provided unit and total price for all CLINs.

(b) Reasonableness – The offeror’s price will be evaluated for reasonableness through one or more of the methods specified in FAR 13.106-2 & 3.

3. In accordance with the requirement of 52.212-1-(b)(6) price and any discount terms:

The total evaluated price will be inclusive of all CLINs for the 12-month base period, the 4-1 year option periods, and the six month extension. The six month extension shall be priced by the offeror, IAW FAR Clause 52.217-8 using the last option year prices (Option Year Four). IAW Local Requirements (Non-construction), Paragraph J, if the extension is exercised, the price for the current option period will be pro-rated IAW FAR Clause 52.217-8 at the rates specified for that option period.

4. The proposal shall be limited to 10 pages, typed at 10 pitch or larger type, single spaced, and single sided, on sheets 8.5" X 11" with 1" margins. This page limitation is inclusive of indexes, photographs, fold-outs, appendices, and attachments. If offer is provided on SF 1449 and any additional required fill-in provisions/clauses by the offeror, these will not be counted towards the 10 page limit. System for Award Management (SAM) shall follow provision stated in 52.212-1(k), submission of any and/or any SAM.Gov information is not required and will not be counted toward the 10 page limit. Any Amendments (if applicable) will not count towards the 10 page limit.

(End of provision)