36C26319Q0574-001.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 51

36C26319Q0574

6. SOLICITATION ISSUE DATE

5/20/2019

JOSH IMDACHA 319-339-7017 06-03-2019

4PM CDT

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241 x

334516

1000 Employees

X

N/A

X

MULTIPLE SITES

SEE SOW

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 x

See CONTINUATION Page

Cost per test Hg A1C testing,instrumentation & supplies See attached Price/Cost Schedule and Statement of Work

THIS IS A TRADE OFFS SOLICITATION SEE EVALUATION PROVISION

52.212-2 FOR DETAILS

This solicitation is being conducted by the VISN 23 Contracting office for the VISN 23 VA Health Care System.

Base Ordering Period: 8/1/2019 to 7/31/2020 Ordering Period 1: 8/1/2020 to 7/31/2021 Ordering Period 2: 8/1/2021 to 7/31/2022 Ordering Period 3: 8/1/2022 to 7/31/2023 Ordering Period 4: 8/1/2023 to 7/31/2024

See CONTINUATION Page As cited on delivery orders x x x 1

36C26319Q0574

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 AUTHORIZED LIMITS

C.2 52.216-18 ORDERING (OCT 1995)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.10 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2019)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] UPON ACCEPTANCE

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

1.1 It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 23) to establish a indefinite delivery/indefinite quantity (IDIQ) for Automated Hemoglobin A1c Instrumentation. The Government will award a CPRR IDIQ to a single Contractor for Automated Hemoglobin A1c Instrumentation.

Contractor agrees to the following terms of the IDIQ exclusively with the VISN 23 facilities listed below and awarded in the final IDIQ. However, as requirements change, facilities within VISN 23 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market.

1.1.1 Participating Facilities:

• VA Black Hills Health Care System, Hot Springs, SD

• VA Black Hills Health Care System, Ft. Meade, SD

• Fargo VA Health Care System, Fargo, ND

• VA Nebraska-Western Iowa Health Care System, Omaha, NE

• VA Nebraska-Western Iowa Health Care System, Lincoln, NE

• VA Nebraska-Western Iowa Health Care System, Grand Island, NE

• St. Cloud VA Healthcare System, St. Cloud, MN

• Sioux Falls VA Health Care System, Sioux Falls, SD

• Twin Ports VA Clinic, Superior, WI

• VA Central Iowa Health Care System, Des Moines, IA

1.2 This IDIQ does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the IDIQ by authorized individuals.

1.3 Prices and Terms VISN 23 will provide an estimated volume of test performed as reflected in Attachment A for each individual medical center. The Government estimates the volumes listed in the attached spreadsheet per facility, but does not guarantee volumes as listed; they are estimates ONLY.

1.4 TERM OF AGREEMENT: This will be a single award, firm-fixed price IDIQ with one base ordering period and four, one year ordering periods. If the Contractor fails to perform in a manner satisfactory to the CO, this IDIQ may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This IDIQ shall be reviewed annually. VISN 23 intends to establish the base year of the contract for the period of August 1, 2019 through July 31, 2024.

1.5 IDENTIFICATION: Delivery Orders issued shall be identified by their applicable IDIQ Number. IDIQ identification numbers are assigned through the VHA Procurement Activity;

1.6 ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 SCOPE OF PROCUREMENT

2.1.1 The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to perform the testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute

(CLSI).

2.1.2 Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.

2.1.3 If Contractor offers a family of analyzers, VISN 23 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

2.1.4 Equipment shall be acquired for each of the clinical laboratories located at the VISN23 facilities listed in Attachment A.

2.1.5 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

2.1.5.1 Two (2) sets of controls and calibration material shall be included sufficient to perform quality control analysis in accordance with regulatory and manufacturer recommendations.

2.1.6 Special handling for emergency orders of supplies: In the event that the supplies 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 is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall 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 shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2.2 DEFINITIONS

2.2.1 Cost per Patient Reportable Result (CPRR) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality 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 per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall 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 the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

A single standard unit CPRR for the entire network based upon the VISN 23 aggregate test volumes should be provided.

2.3 TEST MENU

Refer to Attachment A for a list of estimated annual volumes.

2.4 GENERAL REQUIREMENTS

2.4.1 Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Locations within the same health care system must be proposed identical analyzers. (Grand Island, Lincoln, and Omaha are in the same health care system. Hot Springs and Ft.

Meade are in the same health care system.)

2.4.3 The system must be certified by the National Glycohemoglobin Standardization Program (NGSP).

2.4.4 Coefficient of Variation (CV) must be less than 2%.

2.4.5 Operational Features - The instrumentation offered shall have the following:

2.4.5.1 The capability to perform measurement of analytes to include Hemoglobin A1c utilizing a fully automated analyzer capable of directly measuring total A1c hemoglobin by Ion-exchange High Performance Liquid Chromatography (HPLC).

2.4.5.2 Throughput to meet the volume and service demands of at least twenty-five samples per hour required by all sites.

2.4.5.3 Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

2.4.5.4 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

2.4.5.4.1. Provide accurate barcode reading with less than 1% failure rate.

2.4.5.4.2 Equipment must support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2.4.5.4.3 Equipment must accept, at a minimum, a 10 character specimen identifier that is alphanumeric (letters and numbers).

2.4.5.5 Equipment must be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

2.4.5.6 A specimen handling/loading system.

2.4.4.6.1 Primary specimen container(s) is loaded into a storage area, e.g. tray, rack, wheel, etc. for automated processing.

2.4.4.6.2 Diluting and injecting of the specimen is handled with minimal operator intervention.

2.4.4.6.3 A variety of specimen containers is accepted.

2.4.4.6.4. Primary tube cap piercing is required.

2.4.5.7 Minimal reagent preparation.

2.4.5.8 Capability to store at least 500 patient results in database for immediate recall.

2.4.5.9 Minimal daily, weekly and monthly maintenance.

2.4.6 Technical Features – The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

2.4.6.1 An on-board QC data management system with the ability to capture, store and electronically transfer QC data is highly desirable. A quality control peer group comparison program is highly desirable.

2.4.6.2 Monitors instrument performance and alerts operator to system malfunctions.

2.4.6.3 Long calibration stability (must meet stated column injection life).

2.4.6.4 Minimal carryover.

2.4.6.5 A method for the determination of column and detector integrity must be provided.

2.4.6.6 Complete separation of the labile and stabile hemoglobin A1c.

2.4.6.7 Methodology that provides minimal interference from common hemoglobin (Hb) variants.

2.4.7 Hardware Features - The instrumentation shall have the following:

2.4.7.1 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

2.4.7.2 A monitor/screen that is easily readable. An adjustable monitor is desirable.

2.4.7.3 A printer that has the capability of printing a patient report with patient demographic information that includes minimally accession or unique identifier number (UID).

2.4.7.4 An uninterruptible power supply with line conditioner for each instrument provided under this

IDIQ.

2.4.8 Method Performance/Validation - Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) Standards and federal regulations, for the following:

2.4.8.1 Correlation studies for each analyte. A minimum of 40 samples, spanning the reportable range, shall be run by the present and the proposed method over a time frame of five days. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

2.4.8.2 Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method.

2.4.8.3 Precision study using normal and abnormal control material or patient sample pool. This shall consist of a within run precision study of 10 normal and 10 abnormal controls or patient sample pool and a day-to-day precision study of normal controls and abnormal controls or patient sample pool for 10 days (may be run twice a day) for a total of 20 values per level of control or patient sample pool.

Intra-VISN facility variations should be kept at an absolute minimum.

2.4.8.4 Specificity, Sensitivity, and Interference Studies. A review of product literature and assay inserts to determine specificity, sensitivity, and any adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

2.4.8.5 Carryover Studies. Successful carryover studies shall be completed by the Contractor on all analyzers during installation. These studies shall be performed using either Contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The program(s) shall be provided to each laboratory at no charge.

2.4.9. REFERENCE RANGE. A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

2.4.9.1 A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

2.4.9.2 If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

2.4.10 Support Features

2.4.10.1 Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

2.4.10.2 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

2.4.10.3 Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services.

This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed.

Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

2.4.10.4 Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

2.4.11.4.1 A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours.

2.4.11.4.2 Equipment repair service shall be provided during core business hours.

Core business hours are considered Monday – Friday 0800-1630.

Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

2.4.11.4.3 Equipment response time shall be no more than 24 hours.

2.4.11.4.4 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2.4.11.4.5 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

o date and time notified o date and time of arrival o serial number, type and model number of equipment o time spent for repair, and o proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

2.4.11.4.6 Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.4.11.4.7 When a service Engineer presents at a site for either routine maintenance or repair service, they must follow appropriate facility procedures for check in.

2.4.11.5 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, upgrade of Operating Systems no longer supported, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability.

2.4.11.6 Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the IDIQ, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g.

starter kits, tables/stands, etc.

2.4.11.7 Interface requirements – The Contractor shall be responsible for providing all hardware required for the connection, implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below).

2.4.11.7.1 The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

2.4.11.7.2 If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

2.4.11.8 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g.

Computer disc containing their procedure manual or an on-line procedure manual in the instrument software.

2.4.11.9 Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste at the point of generation before mixing and combined waste at the point of generation as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

2.4.11.9.1 The determination and description shall address the following:

• Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

• Waste ignitability (Reference 40CFR261.21)

• Waste corrosivity (Reference 40CFR261.22)

• Waste reactivity (Reference 40CFR261.23)

• Hazardous waste from non-specific sources (F-listed) (Reference

40CFR261.31)

• Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

• Solid Waste (Reference 40 CFR 261.2)

• Exclusions (Reference 40 CFR 261.4)

• MN Lethality Characteristics (Reference Minnesota Rules

7045.0131, Subp. 6)

2.4.11.9.2 The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.4.11.9.3 Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 C.F.R 261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 C.F.R 261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerasol, phosphates, and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration / measures of the elements and parameters listed below and must be included with vendor response:

• Barium (Total)

• Cadmium (Total)

• Chromium (Total)

• Copper (Total)

• Cyanide (Total)

• Lead (Total)

• Mercury (Total)

• Nickel (Total)

• Silver (Total)

• Zinc (Total)

• Arsenic (Total)

• Selenium (Total)

• Tin (Total)

• pH

• Flash point (to higher than 200 F)

• BOD; biochemical oxygen demand

The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system

2.4.11.10 Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the IDIQ. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.11.10.1 Upon award of a IDIQ, the transition period for the awarded IDIQ to have all equipment and peripherals installed and operational shall be from date of award through 90 days.

During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.4.11.10.2 Contractors shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded IDIQ including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations.

Failure of the Contractor to confirm to the transition period shall be considered as sufficient cause to terminate IDIQ for cause under the Termination for Cause clause of the IDIQ.

2.4.11.10.3 At the end of 90 days from award of the IDIQ, the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ.

2.4.12 Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or IDIQ] is accepted by the government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any IDIQ at an effectiveness level of 90% or more during operational hours.

2.4.12.1 In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2.4.12.2 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR.52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

2.4.12.3 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.

2.4.12.4 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall 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.

2.4.12.5 The government will maintain 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 period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.4.12.6 During the term of the IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% of each month’s operating hours of the term of the contract for equipment.

2.4.13 Government’s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

2.4.14 Ownership of Equipment: Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.)

and shall be responsible for all packing and shipping required to remove the analyzer.

2.5 EVALUATION OF OFFERS

Each respondent for the contract shall meet all the qualifications as outlined in the Statement of Work.

The Government will enter into an contract resulting from this solicitation to the responsible Contractor whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. This contract will be based on the tradeoff evaluation process.

The VA will evaluate vendors on technical specification and price. Vendors must provide all information as described in the section entitled “INSTRUCTIONS TO OFFERORS.” Not providing this information may prevent consideration of the quote.

2.5.1 Technical Specifications: Vendor’s equipment will be evaluated to determine whether it meets all of the basic technical specifications. All such requirements must be met in order for the vendor’s equipment to be considered acceptable for the award of the IDIQ. In addition, an analysis of the feature limitations and enhancements of the equipment along with associated products will be considered. A direct response and supporting documentation, if available, are required for each evaluation criteria. Specific evaluation criteria, which are equal to each other, will include the following:

2.5.1.1 Performance ease/efficiency of operation - Consideration will be given to ease of operation including navigation of software, sampling capabilities including level of automation, primary tube sampling, and sample piercing capabilities, and capacity to meet volume and service demands (time to first result and analysis time). Commercial literature and other information describing compliance with the technical specifications are required. If the commercial literature does not directly address specific situations identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format.

2.5.1.2 Equipment footprint - Offerors will be evaluated on the configuration and ability to conform to existing space, scalability and integration of instrumentation and all peripherals (e.g printer, computer, UPS) proposed for each site. Technical specifications must be provided.

2.5.1.3 Performance ease/efficiency of operation - Consideration will be given to equipment maintenance requirements. Summary of operator-performed and vendor-performed maintenance procedures and provide an estimate of time spent in performance for each category of maintenance.

2.5.1.3.1 Operator performed – Offerors must summarize their maintenance procedures and provide an estimate of time spent in performance for each category, e.g. daily, weekly, monthly, semi-annually, etc. If analyzer is required to be in an offline status, the estimate of time spent on maintenance must include time required to put analyzer in offline and return to run status.

2.5.1.3.2 Vendor performed – Offerors must describe the frequency of preventative maintenance and provide an estimate of time required to perform maintenance. Offerors must confirm equipment response time shall be no more than 24 hours for each location listed in the solicitation.

2.5.1.4 Performance ease/efficiency of operation - Consideration will be given to quality control maintenance, quality control management including ease of submitting data, quality control stability, and calibration requirements. Vendor to supply a summary of quality control practices in addition to software features that may include Levey-Jennings, peer group comparison program, ability to manually enter or remove results, number of results archived and method of data submission, and provide calibration information to include frequency and ease as well as any incremental cost associated with calibration not included in IDIQ.

2.5.1.5 Performance ease/efficiency of operation - Consideration will be given to reagent handling and inventory control. Commercial literature and other information describing compliance with the technical specifications are required. If the commercial literature does not directly address specific situations identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format.

2.5.1.6 Implementation Plan - Consideration will be given to ability to implement equipment within specified timeframe. An equipment implementation schedule and transition plan describing timeframes for full implementation of equipment including installation, training, correlation and validation is required.

2.5.1.7 Product and Waste Evaluation – Consideration will be given to vendors that are environmentally friendly.

Characterization of waste: The Vendor shall provide documentation that it has characterized the hazardous nature of all products and waste produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261. The determination shall address both RCRA listed and characteristic waste to include lethality.

Hazardous product determination- To include all reagents, calibrators, controls, cleaning agents and any other products used by the instrument before use.

Hazardous waste determination- To include the waste streams from the analyzer consisting of patient samples mixed with chemical reagents, calibrators, cleaning agents, controls and any other product used by the instrument. This requires determination of each individual waste generated by the analyzer at the point of generation before mingling or combining with other wastes. Each discharge pipe or container is considered a separate and distinct waste stream; evaluate each separately

Required documentation:

Documentation requires the manufacturer’s technical staff complete a MFG_Waste_Evaluation_Form.

The Chemical Evaluation Form seeks information on the chemical, product as applicable in an unused or partially used state and as it exists in use per manufacturer’s instructions. All ingredients at any concentration must be taken into account as you respond to the questions on the form.

Documentation must include Toxicity Characteristic Leaching Procedure (TCLP) with results reported in mg/L from a representative sample(s) of each individual waste as described in part A.2. When determining the representative sample, the vendor must take into account calibrations, cleanings and number and types of tests specific to the analyzer and its use specific to each facility.

If the vendor has all required information prepared in a similar format, this may be submitted in lieu of the MFG_Waste_Evaluation_Form.

The vendor must provide Safety Data Sheets for all products. A hyperlink to access this data would also be acceptable.

Documentation of all analysis will be provided to the VA Contracting Officer for review by the VISN- 23 Green Environmental Management Systems (GEMS) Coordinator or designee prior to contract award or introduction of new product after award.

2.5.1.13 Information Security - Consideration will be given to the vulnerability and risks associated with electronic Protected Health Information (ePHI) transmitted or maintained by each medical device. A completed VA6550A for each instrument will be provided to the VA Contracting Officer for review by the VISN-23 Information Security Officer (ISO), VISN 23 Office of Information Technology (OIT), VISN 23 BioMedical Engineering, and VISN 23 Medical Technologist Representative for selected vendor(s) only prior to contract award.

2.5.2 Price

The Contractor is asked to submit the quote providing a “Cost-per-Reportable Result” (CPRR) that is all inclusive. Price shall be based upon the VISN-23 aggregate volume.

Provide a single standard unit cost per patient reportable result (untiered pricing) for the entire network based upon the VISN-23 test volumes as a whole. Meaning, the contractor will charge the same unit price per patient reportable result for each facility, no matter the instrumentation or annual volume of each of the individual VA facilities, but will base the price of the CPRR on the aggregate volume of tests for VISN23.

Vendors not having the ability (for manufacturing reasons) to supply a component(s) included in the CPRR as defined in the statement of work and evaluation factors must individually specify the item(s) so that effective comparisons can be made between offers. Vendor to supply a list of any items, including cost, not covered under the IDIQ.

Vendors offering third party products (reagents or consumables) where the cost is included in the CPRR must individually specify the product, source and reference information, indicate whether the third party reagents will be procured by the offeror and the costs are included in the quoted CPRR and certify their technical support of the third party method on the equipment systems.

2.5.3 Past Performance Evaluation

The Contracting Officer will evaluate past performance to assess the offeror’s past performance experience on previous contracts as well as the offeror’ s ability to perform successfully. Past performance tool that will be utilized is the Government wide Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

B.3 PRICE/COST SCHEDULE

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QTY UNIT UNIT PRICE AMOUNT

0001 Hemoglobin A1c cost per reportable BASE

ORDERING PERIOD

162,679 EA __________________ __________________

1001 Hemoglobin A1c cost per reportable

ORDERING PERIOD 1

2001 Hemoglobin A1c cost

ORDERING PERIOD 2

3001 Hemoglobin A1c cost

ORDERING PERIOD 3

4001 Hemoglobin A1c cost

ORDERING PERIOD 4

GRAND TOTAL __________________

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SECTION C - CONTRACT CLAUSES

C.1 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual IDIQ Orders placed against this contract may reach $203,348.75/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the contract is set at over the period covered by the contract; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from effective date through the end of the effective period.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $500.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $203,348.75;

(2) Any order for a combination of items in excess of $203,348.75; or

(3) A series of orders from the same ordering office within 365 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph

(b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY…