36C24826Q0043_1.docx

36C24826Q0043

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

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.

UEI:

EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C24826Q0043 10-27-2025 David Griganavicius 813-796-2945 10-31-2025 16:30

EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 160 Tampa

FL

33637 X 334516 1000 Employees N/A X Department of Veterans Affairs James A. Haley Veterans Hospital (90C) 13000 Bruce B. Downs Blvd Tampa

FL

33612 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Tampa

FL

33637

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin

TX

78714-9971 See CONTINUATION Page See CONTINUATION Page X X Table of Contents

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 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 160 Tampa FL 33637

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

OSMOPRO MAX - Vendor Catalog # OSMOPRO MAX Contract Period: Base POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

MANUFACTURER PART NUMBER (MPN): OSMOPRO MAX

Advanced Instruments Osmo1 Single-Sample Micro-Osmometer - Vendor Catalog # OSMO1

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): OSMO1

OSMOPRO MAX INSTALL/TRAINING - Vendor Catalog # ITV-SKC-PRO MAX

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): ITV-SKC-PRO MAX

INSTL TRNG VLDTN W/ SKC OSMO1 - Vendor Catalog # ITV-SKC-OSMO1

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): ITV-SKC-OSMO1

Advanced Instruments Protinol Serum Osmometer Controls, Concentration: 240, 280, 320mOsm/kg H2O, 9 per Pack - Vendor Catalog # 3MA028

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): 3MA028

Advanced Instruments Renol Urine Control Solution, Concentration: 300 and 800mOsm/kg H2O, 8 per Pack - Vendor Catalog # 3LA085

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): 3LA085

OSMOPROMAX 1 YR ON SITE SERVICE CONTRACT: Vendor Catalog # SC-PROMAX-1YR-PAC

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SC-PROMAX-1YR-PAC

OSMO1 SRVC CONTRACT 1 YEAR: Vendor Catalog # SC-OSMO1-1Y-PAC

POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): SC-OSMO1-1Y-PAC

Option 1. Advanced Instruments Protinol Serum Osmometer Controls, Concentration: 240, 280, 320mOsm/kg H2O, 9 per Pack - Vendor Catalog # 3MA028 Contract Period: Option 1 POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 1. Advanced Instruments Renol Urine Control Solution, Concentration: 300 and 800mOsm/kg H2O, 8 per Pack - Vendor Catalog # 3LA085

POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 1. 1 YR ON SITE SERVICE CONTRACT: Vendor Catalog # SC-PROMAX-1YR-PAC

POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 1. OSMO1 SRVC CONTRACT 1 YEAR: Vendor Catalog # SC-OSMO1-1Y-PAC

POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 2. Advanced Instruments Protinol Serum Osmometer Controls, Concentration: 240, 280, 320mOsm/kg H2O, 9 per Pack - Vendor Catalog # 3MA028 Contract Period: Option 2 POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 2. Advanced Instruments Renol Urine Control Solution, Concentration: 300 and 800mOsm/kg H2O, 8 per Pack - Vendor Catalog # 3LA085

POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 2. 1 YR ON SITE SERVICE CONTRACT: Vendor Catalog # SC-PROMAX-1YR-PAC

POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 2. OSMO1 SRVC CONTRACT 1 YEAR: Vendor Catalog # SC-OSMO1-1Y-PAC

POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 3. Advanced Instruments Protinol Serum Osmometer Controls, Concentration: 240, 280, 320mOsm/kg H2O, 9 per Pack - Vendor Catalog # 3MA028 Contract Period: Option 3 POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 3. Advanced Instruments Renol Urine Control Solution, Concentration: 300 and 800mOsm/kg H2O, 8 per Pack - Vendor Catalog # 3LA085

POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 3. 1 YR ON SITE SERVICE CONTRACT: Vendor Catalog # SC-PROMAX-1YR-PAC

POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 3. OSMO1 SRVC CONTRACT 1 YEAR: Vendor Catalog # SC-OSMO1-1Y-PAC

POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 4. Advanced Instruments Protinol Serum Osmometer Controls, Concentration: 240, 280, 320mOsm/kg H2O, 9 per Pack - Vendor Catalog # 3MA028 Contract Period: Option 4 POP Begin: 12-15-2029 POP End: 12-14-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 4. Advanced Instruments Renol Urine Control Solution, Concentration: 300 and 800mOsm/kg H2O, 8 per Pack - Vendor Catalog # 3LA085

POP Begin: 12-15-2029 POP End: 12-14-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 4. 1 YR ON SITE SERVICE CONTRACT: Vendor Catalog # SC-PROMAX-1YR-PAC

POP Begin: 12-15-2029 POP End: 12-14-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Option 4. OSMO1 SRVC CONTRACT 1 YEAR: Vendor Catalog # SC-OSMO1-1Y-PAC

POP Begin: 12-15-2029 POP End: 12-14-2030 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

B.3 DELIVERY SCHEDULE

Pathology & Laboratory Department 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4745

USA

(813) 426-6006 renae.slaughter@va.gov

Pathology & Laboratory Department 13001 Bruce B. Downs Blvd.

Tampa, FL 33613 4746

USA

Pathology & Laboratory Department 13002 Bruce B. Downs Blvd.

Tampa, FL 33614 4747

USA

Pathology & Laboratory Department 13003 Bruce B. Downs Blvd.

Tampa, FL 33615 4748

USA

Pathology & Laboratory Department 13004 Bruce B. Downs Blvd.

Tampa, FL 33616 4749

USA

Pathology & Laboratory Department 13005 Bruce B. Downs Blvd.

Tampa, FL 33617 4750

USA

Pathology & Laboratory Department 13006 Bruce B. Downs Blvd.

Tampa, FL 33618 4751

USA

Pathology & Laboratory Department 13007 Bruce B. Downs Blvd.

Tampa, FL 33619 4752

USA

Pathology & Laboratory Department 13004 Bruce B. Downs Blvd.

Tampa, FL 33616 4749

USA

Pathology & Laboratory Department 13005 Bruce B. Downs Blvd.

Tampa, FL 33617 4750

USA

Pathology & Laboratory Department 13006 Bruce B. Downs Blvd.

Tampa, FL 33618 4751

USA

Pathology & Laboratory Department 13007 Bruce B. Downs Blvd.

Tampa, FL 33619 4752

USA

Pathology & Laboratory Department 13004 Bruce B. Downs Blvd.

Tampa, FL 33616 4749

USA

Pathology & Laboratory Department 13005 Bruce B. Downs Blvd.

Tampa, FL 33617 4750

USA

Pathology & Laboratory Department 13006 Bruce B. Downs Blvd.

Tampa, FL 33618 4751

USA

Pathology & Laboratory Department 13007 Bruce B. Downs Blvd.

Tampa, FL 33619 4752

USA

Pathology & Laboratory Department 13004 Bruce B. Downs Blvd.

Tampa, FL 33616 4749

USA

Pathology & Laboratory Department 13005 Bruce B. Downs Blvd.

Tampa, FL 33617 4750

USA

Pathology & Laboratory Department 13006 Bruce B. Downs Blvd.

Tampa, FL 33618 4751

USA

Pathology & Laboratory Department 13007 Bruce B. Downs Blvd.

Tampa, FL 33619 4752

USA

Pathology & Laboratory Department 13004 Bruce B. Downs Blvd.

Tampa, FL 33616 4749

USA

Pathology & Laboratory Department 13005 Bruce B. Downs Blvd.

Tampa, FL 33617 4750

USA

Pathology & Laboratory Department 13006 Bruce B. Downs Blvd.

Tampa, FL 33618 4751

USA

Pathology & Laboratory Department 13007 Bruce B. Downs Blvd.

Tampa, FL 33619 4752

USA

36C24826Q0043

Page 1 of Page 1 of B.4 Statement of Need: Automated Osmometer CPT

I. SCOPE:

The Contractor shall provide a two (2) fully automated Osmometer System, including, delivery, installation, training, reagents, consumables for the Tampa VA Healthcare Network (TVAHCN), Department of Pathology and Laboratory Medicine Service (P&LMS) located at 13,000 Bruce B. Downs Blvd., Tampa, Florida 33612.

All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances. FDA and manufacturer's guidelines, with all terms, conditions, provisions, schedules, and specifications provided herein. The Contractor selected is responsible for system installation, maintenance coordination and supply procurement for all equipment.

II. GENERAL REQUIREMENTS:

A. The contractor is required to furnish all of the following:

1. All reagents and supplies necessary to operate the contractor's equipment, including calibrators and or calibration material, reagents, linearity testing material, at least 2 levels of test control material, disposables, consumables, cleaning solutions, diluent solutions, sheath fluids, and any instrument part required for operating all analyzers and equipment.

ADDITIONAL NOTES:

· Contractor shall provide enough reagents sufficient to perform testing at each location for a minimum of 30 days.

· Reagent quality must be high enough to satisfy proficiency testing of the College of American Pathologists and the Joint Commission.

· Contractor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., Contractor is to provide all manpower and reagents/supplies to do correlation studies).

2. Equipment must be able to Interface to the Lab Information System (Vista) / middleware (Data Innovations).

3. All consumables and user-defined replacement parts necessary to operate the contractor's equipment, including secondary, aliquot tubes.

4. On- and/or Off-site training for end users and key operators.

5. Delivery and installation of equipment at no additional charge as well as return shipping costs at end of contract (removal).

6. Contractor to perform equipment and assay installation including full validation of system hardware and software as well as assay performance studies as applicable (assay correlations to existing instrumentation, carryover, linearity, dilution validation, precision, accuracy, reference range studies, and normal range studies).

a. Accuracy studies for each analyte. A minimum of 30 samples, spanning the reportable range, will be run by the present and the new contracted method. Contractors will analyze numbers and provide statistical data to accept the new method. Statistics will consist of at least mean, bias, slope, y-intercept, correlation coefficient, analysis, and meet current standards defined by CLSI.

b. Linearity analysis will be performed on new contracted instrument(s) for each analyte to determine reportable range. A 5-point linearity analysis that adheres to the Beer Lambert Law should be performed as a minimum.

c. Precision study utilizing normal and abnormal control material will be performed. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control.

d. Calibration verification will be performed using samples of known value. These can be calibrators or CAP assayed survey samples, or equivalent.

e. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

f. Reference Range: Determine a reference range for each analyte following CLSI guidelines. Samples used for the reference range study shall be representative of the patient population being tested. Reference range assessment shall be performed for each lab. One of the following protocols should be used:

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

3) If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test shall be provided.

g. Therapeutic range validation studies shall be performed by Contractor for applicable analytes, using CLSI guidelines.

h. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Contractor will provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

i. All technical procedures shall be provided by Contractor on diskette in CLSI format, using software compatible with each Laboratory's computer system, for local modification to meet CAP requirements.

7. All shipping costs for reagents, consumables, supplies and equipment (install and removal at the end of contract) including delivery to the clinical laboratory at all sites. Note: includes emergency, overnight delivery as necessary.

8. Special handling for emergency orders of supplies: If 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 with no shipping expenses.

III. EQUIPMENT – SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:

The purpose of this solicitation is to identify the NAME BRAND OR EQUIVALENT Osmometer instrument and specific functionality and performance-based requirements of the systems. The proposal shall provide descriptive literature that meets the following specifications.

A. The vendor must provide NAME BRAND OR EQUIVALENT for all of the following list of equipment:

1. One (1) Advanced Instruments OsmoPRO® MAX Automated Osmometer

2. One (1) Advanced Instruments Osmo1® Single-Sample Micro-Osmometer

3. Redundant equipment must use the same reagents, controls, calibrators, and consumables, and provide the same reference ranges.

B. General System Requirements – OsmoPRO® MAX Automated Osmometer:

1. All equipment provided must be new.

2. Dimensions (W x D x H): 14.0” x 16.5” x 18” (+ or – 2 inches in any direction).

3. Electrical voltage: 100 to 240 VAC (50/60 Hz)

4. Operating Conditions (must operate ranges below or better):

a. Temperature 18°C to 35°C (64°F to 95°F);

b. 5 to 80% relative humidity (non-condensing)

5. Sample type: Serum, plasma, and urine

6. Sampling must be from the primary tube, no pipetting or aliquoting required

7. Measurement Principle: Freezing point depression

8. Minimum Required Sample Volume: 190 μL

9. Sample Capacity: Must support continuous loading of at least 500 samples or more.

10. Resolution: 1 mOsm/kg H2O

11. Range: 0 to 2000 mOsm/kg H2O

12. Display: Touchscreen with onboard video instructions

13. Memory capacity: 1,000 results / 10,000 events (+ or – 5% for each results / events)

14. Temperature effects: Less than 1 mOsm/kg H2O per 5 °C (9 °F) ambient temperature change

15. Accuracy specifications:

a. Mean value ±2 mOsm/kg H2O from nominal value between 0 and 400 mOsm/kg H2O (1 SD)

b. Mean value ± 0.5% from nominal value between 400 and 1500 mOsm/kg H2O (1 SD)

c. Mean value ±0.75% from nominal value between 1500 to 2000 mOsm/kg H2O (1 SD)

16. Precision (within run) specifications (must meet range for deviation/ variation below, or better):

a. Standard deviation ≤2 mOsm/kg H2O between 0 and 400 mOsmo/kg H2O

b. Coefficient of variation ≤0.5% mOsm/kg H2O between 400 to 1500 mOsm/kg H2O

c. Coefficient of variation ≤0.75% mOsm/kg H2O between 1500 to 2000 mOsm/kg H2O

17. Systems must be barcode driven, random access, and have a precision delivery system.

18. Must be 100% “walk-away” system, monitoring during specimen analysis must be minimal.

19. Must be capable of rules-based resulting of which the operator is notified when flags or warnings occur. The system shall come ready for Auto-verification of negative results.

20. Must not introduce additional chemicals or other fluids to sample that would contaminate the sample which would preclude additional testing if needed.

21. Shall have accurate capability of monitoring reagent usage, and provide reagent inventory upon request, in real time.

22. Regent handling should include on board reagent stability greater or equal to 30 days. Shall have calibration and lot (calibrator and reagent) tracking.

23. The systems shall deliver well established, standout performance on proficiency surveys.

24. The vendor must offer peer group analysis program.

25. The systems shall have minimal maintenance, <30 minutes, with walkaway capability and minimize staff hands-on and free technologists for more critical tasks.

26. An electronic operator’s manual shall be furnished with each model supplied.

27. Temperature and Humidity Requirements (must meet temperature and humidity requirements, or better than, i.e. a wider tolerance for the operating range):

a. Temperature: Between 59- and 86-degrees Fahrenheit (I5 - 30° Celsius)

b. Humidity: Relative humidity between 30 and 80 percent Note: Troubleshooting should be provided for instances in which the operating environmental conditions are out of range.

28. Electrical Characteristics 100-120 VAC for each module, 50/60 Hz, 250 watts max

C. General System Requirements – Osmo1® Single-Sample Micro-Osmometer:

1. All equipment provided must be new.

2. Dimensions (W x D x H): 15″ x 14″ x 15″ (+ or – 2 inches in any direction).

3. Electrical voltage: 100 to 240 VAC (50/60 Hz)

4. Operating Conditions (must operate ranges below or better):

a. Temperature 18°C to 35°C (64°F to 95°F);

b. 5 to 80% relative humidity (non-condensing)

5. Sample type: Serum, plasma, and urine

6. Measurement Principle: Freezing point depression

7. Minimum Required Sample Volume: 20 μL

8. Sample Capacity: One-step direct sampling, aspirate sample and load

9. On-board printer

10. Integrated barcode scanner for traceable sample identification and reduce transcription errors.

IV. SYSTEM DATA MANAGEMENT HARDWARE / SOFTWARE

A. System shall interface instruments to Data Innovations or directly to the Lab Information System (LIS), Vista.

B. Data Management with record storage, including instrument used for testing, for all patient results.

C. Shall include all software and software licenses, interfaces, and hardware (e.g., servers, printers, printer drivers, monitors, UPS, etc.) required for complete system operations. Result, calibration and quality control reports must be available to be printed.

V. PREVENTATIVE MAINTENANCE:

A. The contractor shall provide maintenance, at their expense (travel, labor and parts), to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services.

B. The preventive maintenance shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. Preventative maintenance tasks must be completed within 2 weeks of the due date, based on the date of the previously completed task.

VI. SERVICE AND SUPPORT

A. Contractor shall respond with full service on-site technical support, Monday – Friday, excluding federal holidays, 8am-5pm, for all equipment to keep the equipment in good operating condition and subject to security regulations. Response time within 3 days from date of call.

B. Telephone technical support shall be available 24 hours/day, 7 days/week with follow up on all calls within one hour of initial call. Following determination that service is required, technical on-site support must be provided within 3 Days.

C. The contractor will provide all parts and labor needed to repair the malfunction.

D. Travel, per diem and other expenses associated with the repair will be borne by the contractor.

E. The contractor shall furnish a comprehensive malfunction incident report to the installation upon completion of each maintenance call. The report shall include, at a minimum, the following: (a) date and time of notification (b) date and time of arrival (c) serial number type and model numbers(s) of equipment (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control of the sample run.

F. 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 will be made by the contracting officer representative (COR) of the government to request a replacement the initial laboratory equipment with new equipment.

G. Credit for Prolonged and/or Frequent Equipment Malfunction/Downtime: If a piece of equipment remains inoperative (unable to process patient specimens, perform patient testing, and/or report a valid test result) due to a malfunction through no fault or negligence of the government for a total of 48 hours consecutive hours or more, the contractor shall be assessed damages at the rate of 1/30 of the preceding average three month CPRR billings times the total number of days certified as downtime for each incident. The downtime shall start from the time the user makes a bona fide attempt to contact the contractor's designated representative (technical support hotline) until the equipment is returned to good operating order.

H. Computer Patient Data Handling: No hardware, containing any VA patient information, is to be removed from either location, without the approval and removal of data by the VA Information Technology Department.

I. Failure Mean Time Disclosure: The contractor will state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. In addition, the Contractor will help establish normal ranges. The Contractor will provide emergency backup equipment. Only instruments which are FDA approved will be considered and shall be operational and interface with VA laboratory computer systems and upgrades. This shall be a "tum-key" system.

J. Operator Procedure Manuals: Operator and Service manuals along with CLSI procedures shall be furnished for each instrument model supplied.

VII. DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE:

A. General:

1. The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

2. Request for upgrades or replacement hardware/software, due to workload increase, excessive instrumentation failures will be evaluated as needed or at least annually with communication to the Contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer or assay within the test menu supplied may indicate probable non-compliance with the terms of this contract and will entitle the government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily.

a. “Downtime” is defined as any time the equipment is not available for patient testing due to malfunction, unacceptable quality control, software system errors, or hardware failures. This includes time used for end-user troubleshooting, conversations with technical support or on-site engineer repair/support. Downtime for each incident shall start from the time the government makes a bona fine 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.

b. Standard acceptable performance for the life of the contract is defined as a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification without prolonged downtime (>4 hours) per instance more than 3 times within 30 days or more than 10 instances of downtime (of any length of time) within 30 days. In the event the equipment or an assay does not meet the standard acceptable performance for 30 consecutive days, the government will notify the contractor of the ongoing unacceptable performance, and the performance will be monitored for an addition 90 consecutive days. If after 120 calendar days from the initial date of unacceptability, the vendor does not resolve the performance concerns to meet the governments expectations, the government, through the contracting officer, may request a replacement of the equipment / assay or terminate the order upon mutual agreement.

c. Removal of the existing instrument by the Contractor shall be performed within 30 days following the acceptance of replacement equipment without additional charge to the government.

d. Enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

e. The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government as necessary to ensure compliance with vendor and VA specifications.

3. Returned goods: The VA is responsible for inspecting all products shipped hereunder and will give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor.

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

B. Equipment:

1. The contractor is required to provide new state-of the art equipment. Previously used or discontinued models are not acceptable.

2. Site Preparation: Site preparation specifications shall be furnished in writing by the contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications.

3. Space Requirements, System Specifications, etc.:

a. System specifications shall all be disclosed in the proposed space with limited adjustments. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to manufacturer’s claimed specifications. Crossover from current to new instrumentation shall be performed timely with no interruption in patient care laboratory services.

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

c. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which involve additional expense to the government, shall be made at the expense of the contractor.

4. Acceptance will normally be consummated upon delivery and, when applicable, following installation and completion of personnel training.

5. The VA reserves the right to request a ninety (90) day test and evaluation of all pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COR, the VA will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

6. The contractor shall be responsible for installation, which consists of in-house delivery, positioning and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

7. Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guaranteed date commencing ten calendar days after installation.

8. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

9. Ownership of Equipment shall remain with the contractor. All equipment accessories (hardware and software) 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, will remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. The hard drive will remain within the VA.

C. Reagents / Supplies / Consumables:

1. The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, as needed (including emergency over-night delivery orders) from CALL orders within 24 hours.

2. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission.

3. In the event that the supplies, to include 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 herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government and in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

4. The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology or technology will be at the expense of the Contractor. Alert and Notification of all technical advisory recalls and, or alerts, prior to or simultaneously with field alerts should be forwarded to Laboratory Supervisor and the Laboratory Manager. On or about the first day of each month, the contractor will ensure that each site is furnished with sufficient consumable supplies to produce a volume of tests for that month. Separate deliveries of products will be shipped to each testing site, as applicable. Failure to reserve adequate inventory will result in default.

5. If the supplies / 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 herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order from the government activity, if verbal order is received by 1pm EST time. This will be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume). The Contractor shall reimburse each facility for any costs/supplies related to tests performed by another Contractor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

6. Items Included: The Contractor shall provide all routine and specialty items required to operate and maintain the equipment analyzer in optimal condition, such as but not limited to, standards, controls, calibrators, chemical test strips, printers, consumable equipment parts, and required replacement parts for maintenance or service. Any items excluded by the Contractor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of the any excluded items shall be disclosed in the price proposal.

7. If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival of the monthly standing order and routine supplies are delivered.

8. All deliveries (routine and emergent) of reagents, supplies, consumables must be delivered directly to the laboratory at the expense of the contractor.

VIII. TRAINING

A. The contractor, without additional charge to the government, shall provide training on- and/or off-site for at least two (2) key operating personnel per instrument module installed and all automation system components at the time of installation of the contractor's equipment. The contractor will also supply one (1) additional key operator training slots per year throughout the life of the contract.

B. The contractor shall provide supplemental operating training to (2) two government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

C. Contractor shall provide, install, and train users on the data management system with either on- or off-site training. Additional training will be provided for 2 additional operators throughout the life of the contract.

D. Training of Operating Personnel: The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Representative (COR) to on-site orientation and training to designated personnel in: operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training.

IX. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.

X. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

XI. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least ONE YEAR from shipping date unless FDA requires different expiration date.

XII. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

XIII. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

B.5 Records Management Language for Contracts

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of,…