Solicitation Document R1.doc

CP-1

Solicitation RFP-797-FSS-03-0001-R1 CP-4

NOTICE CONCERNING SOLICITATION

ISSUING OFFICE:

DEPARTMENT OF VETERANS AFFAIRS

NATIONAL ACQUISITON CENTER (049A2-2)

PO BOX 76, BUILDING 37

HINES, IL 60141

CP-FSS-1-C

(MAY 2000)

Standing Solicitation No. RFP-797-FSS-03-0001-R1

(Refreshed 07/2008)

Due Date/Time: (Open & Continuous)

This Acquisition is Unrestricted

Small Business Size Standard: 500 Employees

WORLDWIDE FEDERAL SUPPLY SCHEDULE CONTRACT FOR

FSC GROUP 66, PART III, COST-PER-TEST

CLINICAL LABORATORY ANALYZERS

ANY INFORMATION THAT MAY BE DESIRED ON THIS PARTICULAR SOLICITATION CAN BE OBTAINED FROM THE ISSUING OFFICE ADDRESS SHOWN HEREIN.

CONTRACT PERIOD: Contract periods commence on the date of award (DOA) and expire in five years excluding the option provision described in Clause AS1508, Option to Extend the Term of the Contract. Clause AS1508 can be found in Section C.1.6; and for WORLDWIDE COVERAGE, the clause can be found in Attachments 1 & 2, if offering overseas deliveries.

PLEASE NOTE THE FOLLOWING NEW SOLICTATION FORMAT

OFFERORS ARE TO PAY PARTICULAR ATTENTION TO THE NEW SOLICITATION FORMAT!!

In an effort to streamline the proposal process this solicitation package is issued in a new format. Offerors are hereby advised to read AND RETAIN A COPY OF the entire solicitation document with all of its’ provisons and clauses. OFFERORS WILL be held accountable and responsible for their enforcement. oFFERORS ARE required TO ONLY RETURN THE EXHIBITS AND ATTACHMENTS as outlined on the checklist, which appears before the table of contents. Although the offeror does not have to return an entire copy of the basic solicitation document with all of its’ clauses and provisons, they will be incorporated by reference into the contract award and will be administered in full force and effect.

WORLDWIDE COVERAGE

This solicitation allows for contractors to offer both domestic and overseas delivery under clause I-FSS-103. See Section C.1.2 and Exhibit 1 Central Contractors Registration (CCR)

Effective October 1, 2003, registration in the Central Contractor Registration (CCR) is mandatory. The Central Contractor Registration (CCR) System is a centrally located, searchable database, accessible via the Internet to develop, maintain, and provide sources for future procurements. As a single validated source of data on contractors doing business with the Government, the CCR database enables prospective contractors to update their information in one place via a website (http://www.CCR.GOV). The CCR will not create a total electronic commerce environment, but will help provide a basic framework or foundation that will allow migration to a total electronic commerce environment.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule The HIPAA Privacy Rule promulgates rules governing the security, use and disclosure of Protected Health Information (PHI) by covered entities, including Federal agencies such as the Department of Veterans Affairs (VA). A covered agency must obtain satisfactory written assurances from its business associates that they will appropriately safeguard PHI that is received from or created on behalf of the agency. If the VA FSS contracting officer determines, or is notified by laboratory personnel, that HIPAA is applicable to an offer that is submitted under this schedule, the offeror will be required to enter into a Business Associate Agreement (BAA) with the agency prior to the effective date of the contract; or, if a contract has already been awarded, at any time it is determined that a BAA is required. The BAA will describe the permitted and required uses of PHI by the contractor; provide that the contractor will not use or further disclose the PHI other than as permitted or required by the contract or by law; and require the contractor to use appropriate safeguards to prevent unauthorized disclosure of the PHI. If a duly executed BAA, is already on file between VA and the offeror and/or contractor, no further action is required. For additional information on “Information System Security Requirements” refer to exhibit 1, pages 5-8. For information regarding the BAA contact:

James "Mickey" Gwyn

Business Associate Component Liaison

VHA Office of Information

(615) 896-8525 Office/Fax james.gwyn@va.gov

CP-FSS-2 SIGNIFICANT CHANGES (OCT 1988)

The attention of offeror is invited to the following changes made since the issuance of the last solicitation for the supplies/services covered herein:

Implementation of GSA Advantage

GSA Advantage!(, a menu-driven database system provides on-line access to contract ordering information, terms and conditions, up-to-date pricing, and the option to create an electronic order. Participation in GSA Advantage!( gives you the opportunity to bring your GSA/VA schedule products and services to our Federal customers worldwide via the Internet. Please refer to the following clauses that pertain to electronic data submission:

Clause 552.238-71, Submission and Distribution of Authorized FSS Schedule Pricelists (which provides for submission of pricelists on a common-use electronic medium)

Clause 552.243-72 Modifications (which provides guidance on procedures for updating electronic files after contract award)

Clause I-FSS-600, Contract Pricelists (which provides guidance on the submission of electronic contract data to be added to GSA’s electronic ordering system known as GSA Advantage!()

Clause I-FSS-599, Electronic Commerce—FACNET (which provides information concerning the Government’s initiative to evolve its acquisition process from one driven by paperwork into an expedited process based on electronic commerce/electronic data interchange (EC/EDI))

NOTE: Participation in GSA Advantage!( is mandatory and increases your market exposure and schedule sales.

Incorporation of the Use of Federal Supply Schedule Contracts for Disaster Recovery Purchasing General Services Administration Acquisition Regulation (GSAR) Interim Rule, dated February 1, 2007, GSAR Case No. 2006-G522 --Federal Supply Schedule Contracts -- Recovery Purchasing by State and Local Governments through Federal Schedules, established the authority for State and local Governments to use Federal Supply Schedules to facilitate recovery from major disasters, terrorism, nuclear, biological, chemical, or radiological attacks. The disaster must be declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et. seq.). Participation in the recovery purchasing by Schedule contractors is voluntary. See Attachment 3 for additional information (i.e. clauses and the participation election form).

CP-FSS-3 NOTICE: REQUESTS FOR EXPLANATION OR INFORMATION (MAR 1996)

Oral or written requests for explanation or information regarding this solicitation should be directed to:

Department of Veterans Affairs

National Acquisition Center (049A2-2)

PO Box 76, Building 37

Hines, IL 60141

Phone: 621 I Helpdesk (708) 786-7722 Email: helpdesk.fss621i@va.gov

IMPORTANT: THE ADDRESS DESIGNATED FOR RECEIPT OF OFFERS IS CONTAINED IN BLOCK 9 OF THE SF1449 OR BLOCK 16 FOR OVERNIGHT DELIVERIES AND HAND DELIVERED ORDERS.

CP-FSS-19 PRICING (DEC 1998)

Offerors are advised that separate pricing may be submitted for different countries if separate pricing is consistent with the offeror's commercial sales practice.

552.219-71, NOTICE TO OFFERORS OF SUBCONTRACTING PLAN REQUIREMENTS (June 2005) (VARIATION)

The Department of Veterans Affairs (VA) is committed to assuring that maximum practicable opportunity is provided to small, HUBZone small, small disadvantaged, women-owned, veteran-owned and service-disabled veteran-owned small business concerns to participate in the performance of this contract consistent with its efficient performance. VA expects any subcontracting plan submitted pursuant to FAR 52.219-9, Small Business Subcontracting Plan, to reflect this commitment. Consequently, an offeror, other than a small business concern, before being awarded a contract exceeding $550,000 ($1,000,000 for construction), must demonstrate that its subcontracting plan represents a creative and innovative program for involving small, HUBZone small, small disadvantaged, women-owned, veteran-owned and service-disabled veteran-owned small business concerns as subcontractors in the performance of this contract.

TRADE AGREEMENTS ACT

Products offered under this solicitation having countries of origin other than the United States, “Designated Countries”, “Caribbean Basin Countries”, or “North American Free Trade Agreement (NAFTA) Countries” will not be considered for award. “Designated Countries” and Caribbean Basin Countries” are listed below. Contractor shall only deliver under the contract U.S. made or designated country end products. See FAR 52.225-5 TRADE AGREEMENTS ACT incorporated by reference in Section C.2. The Designated Countries (as of November 2007) are as follows:

DESIGNATED COUNTRIES:

WORLD TRADE ORGANIZATION GOVERNMENT PROCUREMENT AGREEMENT COUNTRIES: (WTO GPA)

Cyprus Czech Republic Denmark

Estonia

Finland

France Ireland Israel

Italy

Japan

Korea (Republic of) Latvia Norway Poland

Portugal

Romania

Singapore

Slovak Republic

FREE TRADE AGREEMENT COUNTRIES:

LEAST DEVELOPED COUNTRIES:

Bhutan

Burkina Faso Ethiopia

Gambia Nepal

Niger Yemen

Zambia

Burundi

Cambodia Guinea

Guinea-Bissau Rwanda

Samoa

Cape Verde

Central African Republic Hati

Kiribati Sao Tome and Principe

Senegal

CARIBBEAN BASIN COUNTRIES:

Aruba Bahamas Costa Rica Dominica Jamaica Montserrat St. Vincent and the Grenadines

CP-FSS-30 (APR 1993)

PLEASE REMOVE THESE COVER PAGES BEFORE SUBMITTING OFFER TO VA.

NEW OFFERS MAY BE FORWARDED AT ANY TIME: HOWEVER, TO ASSIST US IN MANAGING THE WORKFLOW, IT IS SUGGESTED THAT YOU SUBMIT YOUR COMPLETED PACKAGE WITHIN A REASONABLE AMOUNT OF TIME FOLLOWING RECEIPT OF THIS SOLICITATION PACKAGE.

IT IS REQUESTED THAT A SINGLE ORIGINAL SIGNED AND DATED OFFER CONTAINING ALL OF THE ELEMENTS OUTLINED IN THE ATTACHED CHECK LIST BE SUBMITTED IN A THREE (3) INCH, THREE (3) RING BINDER(S)

COMPLETED

EXHIBIT 1

SPECIAL INSTRUCTIONS FOR PROPOSAL PREPARATION AND CONTRACT DATA – Read and maintain a copy.

EXHIBIT 1

COVER PAGE TO CONTRACT DATA – Complete and submit this as the first page of your proposal.

EXHIBIT 1

COMPLIANCE CONFIRMATION- Submit a copy of, or evidence of, the requested registrations.

EXHIBIT 1

ACH Vendor/Miscellaneous Payment Enrollment Form (Upon completion, this form must be forwarded to the VA Finance Center Austin, TX. Do not include it with your offer submission)

EXHIBIT 1

EXHIBIT 1 (Pages 12 – 33) – Complete and submit these pages in their entirety.

EXHIBIT 2

TECHNICAL PROPOSAL INSTRUCTIONS – Submit a comprehensive technical proposal by responding to Sub-Factors A, B, C, and D per the technical proposal instructions.

EXHIBIT 3

PRICE PROPOSAL – Complete Attachments 1a, 2a - 2d, 3a – 3d (General information for submission of pricing)

EXHIBIT 4

SMALL BUSINESS SUBCONTRACTING PLAN – (Complete only if applicable under Clause 552.219-71 on CP-3 (Exhibit 4 is not applicable to Small Businesses) )

All offerors are to complete:

AND SEND TO VA – MAIL TO ADDRESS ON COVER PAGE OF SOLICITATION

SECTION

DESCRIPTION

552.211-73 MARKING (FEB 1996)

552.211-74 CHARGES FOR MARKING (FEB 1996)

552.211-75 PRESERVATION, PACKAGING AND PACKING (FEB 1996)

552.211-77 PACKING LIST (FEB 1996)

i-fss-546 GUARANTEE (EXPRESSED WARRANTY) (APR 1984) (VARIATION)

552.246-73 WARRANTY – MULTIPLE AWARD SCHEDULE (MAR 2000)

i-FSS-103 SCOPE OF CONTRACT-WORLDWIDE (JUL 2002)(VARIATION 2004)

52.216-22 Indefinite Quantity (OCT 1995) (Variation – OCT 1995)

G-FSS-910 DELIVERIES BEYOUND THE CONTRACTUAL PERIOD—PLACING OF ORDERS (OCT 1988)

52.216-18 ORDERING (OCT 1995)(DEVIATION FEB 2007)

AS3025 PLACEMENT OF ORDERS (SEP 2003)

552.216-72 PLACEMENT OF ORDERS (SEP)(ALTERNATE II SEP 1999)(VARIATION)

AS3025 PLACEMENT OF ORDERS (SEP 2003)

AS3016 ORDER LIMITATIONS (DEC 2004)

G-FSS-907 ORDER ACKNOWLEDGMENT (APR 1984)

I-FSS-140-B URGENT REQUIREMENTS (JAN 1994)

I-FSS-646 BLANKET PURCHASE AGREEMENTS (MAY 2000)

552.232-83 CONTRACTOR'S BILLING RESPONSIBILITIES (MAY 2003)

52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER – CENTRAL CONTRACTOR REGISTRATION (OCT 2003)

52.232-34 PAYMENT BY ELECTRONIC FUNDS TRANSFER – OTHER THAN CENTRAL CONRACTOR REGISTRATION (MAY 1999)

52.232-8 DISCOUNTS FOR PROMPT PAYMENT (APR 1989)

(DEVIATION FAR 52.232-8)

52.232-17 INTEREST (JUN 1996)

52.232-37 MULTIPLE PAYMENT ARRANGEMENTS (MAY 1999)

552.232-77 PAYMENT BY GOVERNMENTWIDE COMMERCIAL PURCHASE CARD (MAR 2000) (ALTERNATE I – MAR 2000)

52.232-35 DESIGNATION OF OFFICE FOR GOVERNMENT RECEIPT OF ELECTRONIC FUNDS TRANSFER INFORMATION (MAY 1999)

552.232-23 ASSIGNMENT OF CLAIMS (SEP 1999)

52.232-7 PAYMENTS UNDER TIME-AND-MATERIALS AND LABOR HOUR CONTRACTS (FEB 2007)(ALTERNATE I)(FEB 2007)

SECTION

DESCRIPTION

I-FSS-639 CONTRACT SALES CRITERIA (MAR 2002)

I-FSS-680 DISSEMINATION OF INFORMATION BY CONTRACTOR (APR 1984)

I-FSS-600 CONTRACT PRICE LISTS (JUL 2004)

552.238-71 SUBMISSION AND DISTRIBUTION OF AUTHORIZED FSS SCHEDULE PRICELIST (SEP 1999) (DEVIATION –DEC 2004) (VARIATION)

I-FSS-599 ELECTRONIC COMMERCE-FACNET (SEP 2006)

I-FSS-597 GSA ADVANTAGE! (SEP 2000)

552.238-74 INDUSTRIAL FUNDING FEE AND SALES REPORTING (JUL 2003) (VARIATION)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

552.243-72 MODIFICATIONS (MULTIPLE AWARD SCHEDULE) (JUL 2000)

552.238-75 PRICE REDUCTIONS (MAY 2004)

AS1508 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2005)

I-FSS-95 RE-REPRESENTATION OF SIZE STATUS FOR OPTION PERIODS

(JAN 2008)

I-FSS-50 PERFORMANCE REPORTING REQUIREMENTS (FEB 1995)

52.228-5 INSURANCE–WORK ON A GOVERNMENT INSTALLATION COVERAGE

552.238-73 CANCELLATION (SEP 1999)

552.229-71 FEDERAL EXCISE TAX-DC GOVERNMENT (SEP 1999)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

52.237-3 CONTINUITY OF SERVICES (JAN 1991)

I-FSS-140-B URGENT REQUIREMENTS (JAN 1994)

I-FSS-644 DEALERS AND SUPPLIERS (OCT 1988)

I-FSS-646 BLANKET PURCHASE AGREEMENT (MAY 2000)

AS1904 REGULATORY REQUIREMENT PROVISIONS (AUGUST 2000)

AS214 PRODUCT MODIFICATION, REMOVAL OR RECALL (JAN 2008)

AS215 PRE-MARKET APPROVAL (AUGUST 2000)

852.211-70 SERVICE DATA MANUAL (NOV 1984) (DEVIATION)

52.203-3 GRATUITIES (APR 1984)

552.203-71 RESTRICTION ON ADVERTISING (SEP 1999)

I-FSS-109 ENGLISH LANGUAGE AND U.S. DOLLAR REQUIREMENTS (MAR 1998)

52.242-13 BANKRUPTCY (JUL 1995)

52.215-20 REQUIREMENTS FOR COST OR PRICING DATA OR INFORMATION OTHER THAN COST OR PRICING DATA (OCT 1997)

(ALTERNATIVE IV-OCT 1997)(VARIATION 1-SEP 1999)

52.215-21 REQUIREMENTS FOR COST OR PRICING DATA OR INFORMATION OTHER THAN COST OR PRICING DATA-MODIFICATIONS

(OCT 1997)(ALTERNATIVE IV-OCT 1997)(VARIATION1-AUG 1997)

AS13 EXAMINATION OF RECORDS BY VA (MULTIPLE AWARD SCHEDULE)

(FEB 1998)

552.215-72 PRICE ADJUSTMENT-FAILURE TO PROVIDE ACCURATE INFORMATION (AUG 1997)

I-FSS-106 GUARANTEED MINIMUM (JUL 2003)

I-FSS-125 REQUIREMENTS EXCEEDING THE MAXIMUM ORDER (SEP 1999)

52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (APR 2008)

I-FSS-965 INTERPRETATION OF CONTRACT REQUIREMENTS (APR 1984)

SECTION

DESCRIPTION

552.212-72 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS APPLICABLE TO GSA ACQUISITION OF COMMERCIAL ITEMS (SEP 2003)

52.223-5 POLLUTION PREVENTION AND RIGHT TO KNOW INFORMATION

(AUG 2003)

52.222-1 NOTICE TO THEGOVERNMENT OF LABOR DISPUTES (FEB 1997)

I-FSS-249-B DEFAULT (MAY 2000)

AS3024 GOVERNMENT’S FAILURE TO PROVIDE ADDITIONAL FUNDING (SEP

2003)

AS3026 EARLY TERMINATION (SEP 2003)

552.212-70 PREPARATION OF OFFER (MULTIPLE AWARD SCHEDULE)(AUG 1997)

52.216-1 TYPE OF CONTRACT (APR 1984)

A-FSS-11 CONSIDERATION OF OFFERS UNDER STANDING SOLICITATION (DEC 2000)

A-FSS-12-C PERIOD FOR ACCEPTANCE OF OFFERS (NOV 1997)

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON RECYCLED PAPER (AUG 2000)

52.214-34 SUBMISSION OF OFFERS IN THE ENGLISH LANGUAGE (APR 1991)

52.214-35 SUBMISSION OF OFFERS IN U.S. CURRENCY (APR 1991)

52.222-24 PREAWARD ON-SITE EQUAL OPPORTUNITY COMPLIANCE REVIEW (FEB 1999)

L-FSS-101 FINAL PROPOSAL REVISION (JUN 2002)

L-FSS-59 AWARD (APR 1984)

552.219-72 PREPARATION, SUBMISSION, AND NEGOTIATION OF SUBCONTRACTING PLANS (JUN 2005)

552.217-71 NOTICE REGARDING OPTION(S) (NOV 1992) (VARIATION)

52.233-2 SERVICE OF PROTEST (SEP 2006)

852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (JAN 2008)

852-233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)

B-FSS-96 ESTIMATED SALES (NOV 1997)

EXHIBITS & ATTACHMENTS

1. CONTRACT DATA – INSTRUCTIONS

SF 1449

Cover Page to Offer

Compliance Confirmation

Information and Information System Security Requirements

Exhibit Pages 7 through 25

Sub Factor A – Corporate Experience

Sub Factor B – Management Plan Sub Factor C – Responsibility/Past Performance

Sub Factor D – General Liability Insurance

COMMERCIAL SALES PRACTICE DISCLOSURES (CSP)

(Note: Attachments are in Microsoft Excel format)

Attachment 1a - Schedule of Items, Annual Estimated Requirements Attachment 2a –Commercial Sales Practice Disclosures (CSP) Attachment 2b – CSP Spreadsheet Attachment 2c – CPT/CPRR Price Analysis Disclosures Attachment 2d – CSP Spreadsheet (Continued) Attachment 3a – CPT/CPRR Proposed Pricing Model Attachment 3b – FSS Proposed Pricing Breakdown for CPT/CPRR Attachment 3c – FSS Proposed Adjustments to CPT/CPRR Pricing Attachment 3d – CPT/CPRR Proposed Pricing Model (Sample)

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SECTION A - STANDARD FORM 1449

Note: SF 1449 is hereby incorporated by reference and contained in solicitation Exhibit 1.

SECTION B - CONTINUATION OF STANDARD FORM 1449

Note: Schedule of Items is hereby incorporated by reference and contained in solicitation Exhibit 3, Attachment 1a.

GENERAL DEFINITIONS

Cost Per Test (CPT)

Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

Cost Per Reportable Result (CPRR)

Contractors are required to provide a price for a reportable patient result. The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS). (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

Clinical Laboratory Analyzers

Clinical Laboratory Analyzers includes clinical laboratory analyzers for chemistry, coagulation, urinalysis, microbiology, and immunochemistry. (May also include supported clinical Chemistry Assays designed for the qualitative and/or quantitative detection and identification of drugs of abuse, which may be present in the biological fluids).

Acceptable CPT/CPRR Pricing Model Per test or per reportable result fixed pricing approaches include but are not limited to the following two models.

1. Matrices of all net prices inclusive of subject fixed and variable costs as indicated in the above definitions.

2. Pricing of subject fixed and variable costs broken down individually and subject to an acceptable calculation that would be applied, resulting in the net fixed price consistent with the requirement of the solicitation.

B.1 .1 General Background / Requirements Clinical Laboratory Assays

Clinical laboratory assays currently performed in Government laboratories include (but are not limited to) the following assays. Contractors shall complete a "Technical Data Sheet" for each model of clinical laboratory analyzer being offered (See “Exhibit 2” for the Technical Data Sheet attachment), and a "Cost-Per-Test and Cost Per Reportable Result Offer Sheet" (See “Exhibit 3” and the CPT/CPRR Pricing Model which is Attachment 3a) listing all supported test assays on each model (provide all required “per-test” pricing data. Contractor’s who are offering Worldwide Coverage must complete Attachment 2, Price Proposal (WORLDWIDE/OVERSEAS DELIVERY).

I.

CLINICAL CHEMISTRY ASSAYS - SPECIAL ITEM NUMBER (SIN): 605-1

II.

CLINICAL HEMATOLOGY ASSAYS - SPECIAL ITEM NUMBER (SIN): 605-2

CBC

DIFFERENTIAL

III.

CLINICAL COAGULATION ASSAYS - SPECIAL ITEM NUMBER (SIN): 605-3

PROTHROMBIN TIME (PT)

PTT

SPECIAL PROCEDURES

IV.

CLINICAL URINALYSIS ASSAYS - SPECIAL ITEM NUMBER (SIN): 605-4

GENERAL URINALYSIS

V.

CLINICAL MICROBIOLOGY ASSAYS - SPECIAL ITEM NUMBER (SIN): 605-5

C & S BLOOD

C & S URINE

SUSCEPTIBILITY TESTING

VI.

IMMUNOCHEMISTRY ASSAYS - SPECIAL ITEM NUMBER (SIN): 605-6

B.1 .1 General Background / Requirements (continued)

SPECIFIC REQUIREMENTS:

Offered model (s) of clinical laboratory analyzers shall be capable of producing accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Model (s) will provide an accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

(1) High Maintenance/Complexity Clinical Laboratory Analyzers Instrumentation whose operation typically requires formal operator training and extensive maintenance and repair.

(2) Low Maintenance/Complexity Clinical Laboratory Analyzers Instrumentation whose operation and maintenance does not require formal operator training and extensive maintenance and repair.

SERIAL NUMBERS:

Each clinical laboratory analyzer shall have the manufacturer's serial number permanently and legibly stamped or affixed on a major component in a readily accessible location. In addition, each laboratory analyzer shall be permanently and legibly marked in a conspicuous location with the manufacturer's name or trademark and model number.

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B.1.2 Statement of Work

STATEMENT OF WORK

CLINICAL LABORATORY ANALYZERS

The contractor shall furnish all clinical laboratory analyzer equipment including: (a) consumable supplies, standards, controls, reagents and disposables; (b) installation; (c) emergency repair service and preventive maintenance; (d) computer interface; and (e) operator training for Government personnel.

The Government will award multiple award indefinite delivery, indefinite quantity contracts for requirements as specified throughout this Request for Proposals (RFP).

Contractors are required to provide a price for each test and/or patient reportable result in accordance with the CPT and CPRR definitions on page 3 of this solicitation that can be performed on its equipment. The per test and per reportable result price shall include costs covering: (a) equipment use, (b) all consumables, reagents, standards, controls and supplies, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance, and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation including all materials required to validate their equipment and removal of equipment at no additional charge.

I. EQUIPMENT CAPABILITIES

Each model of clinical laboratory analyzer offered under this RFP shall comply with all general requirements stated herein. The offered clinical laboratory analyzer software shall have the immediate capability to interface with the Veterans Health Information Systems and Technology Architecture (VistA) (VA laboratory information system) without using commercial software packages. Each contractor must submit as part of their offer, technical data or descriptive literature to ascertain that the equipment offered meets the requirements outlined below.

By signing this offer the contractor is certifying that the equipment will regularly function without excessive malfunctions, breakdowns, or service calls. A high incidence of such problems with any equipment/model supplied may indicate probable non-compliance with the terms of this contract and will entitle the Government to its replacement with other model(s) that can produce the required minimum number of sample results per hour in a manner that is satisfactory to the user. See page 10, paragraph IV (D) for replacement policy.

A. GENERAL REQUIREMENTS (Applicable for all equipment)

1. Contractors are required to have at least one year corporate experience in providing products and services relative to this solicitation in order to qualify for an award. (See Exhibit 2 Technical Proposal - Instructions, Sub-Factor A)

2. The contractor shall provide new state-of-the-art equipment unless the ordering activity agrees to accept remanufactured state-of-the-art equipment at an agreed upon discount. Discontinued models are not acceptable.

3. The contractor shall provide all upgrades to the equipment hardware and operating system software, without additional charge to the Government (e.g. upgrades that corrects either a mechanical or software deficiency of the system). These enhancements to the contractor's equipment shall be delivered to the Government site and installed within sixty (60) days of B.1.2 Statement of Work (continued) A. GENERAL REQUIREMENTS (Applicable for all equipment) (Continued) their issuance or date of first commercial availability. Any upgrade that is supplemental and retrofitted to the initial contracted features of the model (e.g. connection with another piece of equipment, new specimen tracking system, new module that adds new tests and or different methodologies to their instrument, expansion of their reagent storage capabilities, etc AND is being marketed to their commercial customers at a cost, would not be included in the contracted cost of the equipment. The Contractor may request a contract modification by submitting a request to the Contracting Officer for approval (See clause 552.243-72 MODIFICATIONS (MULTIPLE AWARD SCHEDULE located in Section C.1.6).

4. The models being offered are in current production as of the date this offer is submitted. "Equipment placed at an ordering activity under previous FSS 66 III contract is acceptable." For purposes of this solicitation, "current production" shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

5. Any models offered as remanufactured state-of-the-art equipment must have been inspected and tested to "new machine" standards. The contractor shall furnish a certified copy of the inspection and test reports.

6. The offered model will be made available in the same condition of production (as newly manufactured and remanufactured state-of-the-art equipment) as offered for a period of at least one (1) year after the date of contract award.

7. Offered models shall perform satisfactorily at any laboratory temperature between 50 and 90 degrees Fahrenheit, (10 and 32 Celsius).

8. Offered models shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent.

9. An operator's manual shall be furnished with each model supplied.

Electronic formats (e.g. on a CD) are acceptable.

II. INVENTORY CONTROL REAGENTS, SUPPLIES AND DISPOSABLES

All consumable supplies (reagents, standards, control, disposables, etc.) required for the proper operation of the contractor's equipment and necessary to perform tests on the equipment provided shall be included, and shall be furnished by the contractor for each clinical laboratory analyzer model.

On Government provided space the contractor will ship as well as insure that there is a sufficiently stocked inventory of reagents, standards, controls, supplies, disposables and any other material required to properly perform tests on the offered equipment. The contractor may allow the Government facility to place an order based on their expected inventory needs as indicated in their delivery order and or based upon adjustments made during quarterly reconciliations. These items will be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).

B.1.2 Statement of Work (continued)

II. INVENTORY CONTROL REAGENTS, SUPPLIES AND DISPOSABLES (CONTINUED)

A. DELIVERY OF SUPPLIES

On or about the first day of each month, the contractor will insure that each site is furnished with sufficient consumable supplies to produce a volume of tests equal to that stated in the Delivery Order.

B. SPECIAL HANDLING FOR EMERGENCY ORDERS OF SUPPLIES

In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor will deliver to the Government site, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory will result in default.

III. MAINTENANCE

A. GENERAL PROVISIONS

1. The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to Government security regulations; the Government shall provide the contractor access to the equipment for servicing.

2. Preventive Maintenance. Contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. However, if scheduled maintenance services for commercial customers exceeds the manufacturer’s operation and maintenance instructions, the same shall be provided to the Government for the same model of clinical laboratory equipment.

3. User will perform daily routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions.

B. EMERGENCY REPAIR

Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the Government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification.

The contractor must be capable of performing emergency repair service 24 hours per day, 7 days per week (except when the ordering facilities elects reduced service at contract agreed reduction offered under Attachment 3c of Exhibit 3 of this solicitation). The contractor must respond within a mutually acceptable time frame that is negotiated between the contractor and B.1.2 Statement of Work (continued)

III.

MAINTENANCE (CONTINUED)

B. EMERGENCY REPAIR (CONTINUED)

the Government facility. The contractor will provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair will be borne by the contractor.

The contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following: (a) date and time notified; (b) date and time of arrival; (c) serial number, type and model number(s) of equipment; (d) time spent for repair; (e) description of malfunction and repair; and (f) proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

C. MAINTENANCE CREDIT FOR EQUIPMENT MALFUNCTION

If an instrument remains inoperative due to a malfunction through no fault or negligence of the Government for a total of more than twenty-four hours, the contractor shall be assessed damages which will be applied to the invoice in the form of a credit or deduction, at the rate of 1/30 of the preceding average 3 month cost-per-test/reportable billings times the total number of days certified as downtime. In the event that there is no history of cost-per-test/reportable billings then the estimated volumes that were established and agreed to in the contract document (e.g. blanket purchase agreement or order placed against the contract) will be used. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the contractor's designated representative at the prearranged contact point until the machine is returned in good operating order. However, if the delivery/task order provides for emergency repair during normal business hours in lieu of twenty-four hour service, the non contracted maintenance (Emergency Repairs) days will not be included in the downtime calculation.

D. REPLACEMENT LABORATORY EQUIPMENT

During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination may be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment.

The responsibility for maintaining the equipment furnished in good condition shall be solely that of the contractor.

The Government agrees to maintain the equipment according to manufacturer's specifications.

The contractor shall remove the equipment at the expiration of the term of the multi-year pricing arrangement (may encompass performance under previous or ensuing contracts) unless the Government opts to retain the equipment at the reduced contract price.

B.1.2 Statement of Work (continued)

IV. TRAINING AND TECHNICAL SERVICE

TRAINING

The contractor, without additional charge to the Government, shall provide training, at a Government location, for two operating personnel at the time of installation of the contractor's equipment. Annually, the Government may appoint a replacement person to receive contractor provided training, without additional charge to the Government. In addition, the contractor shall provide supplemental operating training to the Government personnel, without additional charge to the Government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this contract.

At the Government's request, the contractor shall furnish training for additional personnel. The expenses associated with the training of additional personnel shall be borne by the Government as set forth in Exhibit 3, Attachment 3c.

Additionally, the contractor, at its discretion may make training available at its facility on terms and conditions mutually agreed upon by the agency and the contractor.

V. SITE PREPARATION

A. Site specifications will be ascertained through analysis of the published requirements in the manufacturer's literature.

B. The Government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor.

C. The contractor shall inspect the site on the date and time acceptable to using activity. The contractor shall report to the Government the inspection dates, any rejections, the reasons therefore and the final inspection and acceptance results. The results will be utilized to assure that the instrument would be in the appropriate environment for optimum use.

D. Any alterations or modification in site preparation that are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the Government, shall be made at the expense of the contractor.

E. Any such site alterations or modifications as specified in Subparagraph d. above which cause a delay in the installation date will also result in liquidated damages for equipment as specified in Paragraph III. (C) on page 10.

VI. DELIVERY AND INSTALLATION

INSTALLATION

Within 72 hours after the date of the analyzer's delivery to the installation site (delivery of the analyzer by the contractor is F.O.B. to the installation site within the Government facility), the contractor's representative shall satisfactorily perform (and complete) the installation/setup of the analyzer. Installation is required within 72 hours after site preparation has been completed in conformance with Pages 11-12, Paragraph V and mutual agreement has been reached as to site preparation acceptability.

B.1.2 Statement of Work (continued)

VI. DELIVERY AND INSTALLATION (CONTINUED)

INSTALLATION (CONTINUED)

Installation by the contractor's representative shall be complete, and in accordance with the manufacturers installation and operation manuals/instructions, and shall include, as a minimum:

A. Unpacking the analyzer from the shipping crate;

B. Taking system component (and accessories) inventory, and performing inspection to insure that all required analyzer components are present, in working order, and undamaged;

C. Assembling the analyzer into its normal operational configuration; this includes making any required connections for electrical power, drain or vent lines, gas/compressed air, etc. and software installation (loading into computer based/controlled analyzers any operating/configuration software);

D. Performing a complete system operation check (including all system diagnostics, standardization/calibration of the analyzer, making any required electrical or mechanical adjustments, and performance of a trial sample run as required to verify quality control/system performance); and

E. Providing the operator training for two Government personnel at the time of installation (as specified in paragraph V. Training and Technical Service of this contract).

Before leaving the installation site, the contractor's representative shall provide the Government with:

A. A certified copy verifying the analyzer's operation performance (the level of performance must be within the manufacturer's specifications for a new analyzer);

B. All required operating manuals, etc. (as specified in the General Requirements section of this contract); and

C. A telephone number for the contractor's technical support/assistance department for the supported analyzer.

NOTE: The performance period shall commence on the date of the installation by the contractor's representative.

VII. OWNERSHIP OF EQUIPMENT

Title to equipment provided under this contract shall remain with the contractor. All accessories (unused consumable, etc.) furnished by the contractor shall accompany the equipment when returned to the contractor.

The contractor, upon expiration of order(s), replacement of equipment per paragraph IV.D. of the preceding page, or notice of termination of the order or contract will remove equipment. The contractor will disconnect the analyzer (gas, water, air, etc.), and will be responsible for all packing and shipping required to remove the analyzer within seven (7) calendar days.

B.1.2 Statement of Work (continued)

VIII. STANDARD OF PERFORMANCE FOR ACCEPTANCE

This section establishes a standard of performance, which must be met before any equipment listed on the purchase order is accepted by the Government. This also covers any replacement, substitute machines and machines, which are added, or field modified, after a system has completed a successful performance period.

The performance period shall begin on the installation date and shall end when the equipment has met the standard of performance for a period of thirty consecutive calendar days by operating in conformance with the contractor's technical specification or as quoted in any proposal at an effectiveness level of 90% or more. The contractor shall be notified when the standard of performance has been completed and performance met.

In the event the equipment does not meet the standard of performance during the initial thirty consecutive calendar days the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of thirty consecutive days.

If the equipment fails to meet the standard of performance after ninety (90) calendar days, from the installation date, the Government may at its option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 (m) entitled "Termination for cause". The contractor will receive payment for tests actually performed by the Government that would appropriately be invoiced under normal operational conditions during the 90 day acceptance period.

Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use.

System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure.

Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

During the performance period for a system a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

The Government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period.

Operations use time and downtime shall be measured in hours and whole minutes.

SECTION C – 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (FEB 2007)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or re-performance of nonconforming services at no increase in contract price. The Government must exercise its post-acceptance rights-

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include-

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

SECTION C – 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (FEB 2007) (CONTINUED)

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper…