36C25918Q0121-001.docx

36C25918Q0121

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.

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

36C25918Q0121 04-10-2018 Juanita Street 303-712-5736 05-02-2018 12:00pm 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 X X X Y 334516 1000 Employees N/A X Eastern Oklahoma VA Health Care System Oklahoma City VA Health Care System Ernest Childers VA Outpatient Clinic Lawton/Fort Sill VA Clinic

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 This RFQ solicitation is to procure Coagulation Cost per Reportable Result (Instruments/Analyzers, Reagents, Supplies, Maintenance, Repair and Training) for Eastern Oklahoma VA Health Care System (Muskogee, OK), Oklahoma City VA Health Care System (Oklahoma City, OK), Lawton/Fort Sill Community Based Outpatient Clinic (CBOC) and Ernest Childers VA CBOC (Tulsa, OK).

A single Blanket Purchase Agreement will be awarded.

See the Statement of Work, Schedule, and Instructions to Offerors (for submitting a quote) in the following pages.

Contract Specialist: Juanita Street, Juanita.Street@va.gov X X X 36C25918Q0121

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

B.1.1. Contract Administration: All contract administration matters will be handled by the following individuals:

B.1.1.2. GOVERNMENT: Juanita Street, Contract Specialist Department of Veterans Affairs Rocky Mountain Network NCO 19 Contracting 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Telephone: 303-712-5736

FAX: 303-712-5824

E-mail: Juanita.Street@va.gov

B.1.2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

c. Other [Monthly in Arrears]

B.1.4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically to the VA Financial Services Center for payment processing, free of charge. For any questions about the e-invoicing program, please contact the FSC at the phone number or email address listed below:

1. OB10 e-Invoice Setup Information: (877) 752-0900

1. OB10 e-Invoice email: USClientServices@ob10.com

1. FSC e-Invoice Contact Information: (877) 353-9791

1. FSC e-invoice email: vafsccshd@va.gov

1. The following two codes will be required when creating a vendor profile in OB10:

· OB10 Buyer Number AAA544240062

· Promo Code: VAPC7Y18

B.1.5. DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided: ___________________________________________.

B.1.6. TAX IDENTIFICATION NUMBER: Please provide the tax identification number to be utilized for this contract: ________________________________________.

B.1.7. PERIOD OF PERFORMANCE: POP will be for a base plus four option year renewals as follows:

B.2 COAGULATION TEST SCHEDULE

COAGULATION COST PER REPORTABLE RESULT TESTING (CPRR) SCHEDULE

TOTAL ESTIMATED QUANTITIES: These are reportable quantities (not including repeats, calibrations, controls or dilutions) BASE YEAR: June 1, 2018 – May 31, 2019

Estimated Annual Quantities

TOTAL ESTIMATED COST BASE YEAR

OPTION YEAR 1: June 1, 2019 – May 31, 2020

Estimated Annual Quantities

TOTAL ESTIMATED COST OPTION YEAR 1

OPTION YEAR 2: June 1, 2020 – May 31, 2021

Estimated Annual Quantities

TOTAL ESTIMATED COST OPTION YEAR 2

OPTION YEAR 3: June 1, 2021 – May 31, 2022

Estimated Annual Quantities

TOTAL ESTIMATED COST OPTION YEAR 3

OPTION YEAR 4: June 1, 2022 – May 31, 2023

Estimated Annual Quantities

TOTAL ESTIMATED COST OPTION YEAR 4

ESTIMATED TOTAL CPRR COSTS (For Base plus 4 Option Years): ________________________

SPECIALTY COAGULATION COST PER TEST SCHEDULE (FOR OKLAHOMA CITY ONLY)

Note 1.0: Run as needed on a stat by case basis. For Routine testing, batched 1/week.

The below tests may be Cost per Test or Cost per Kit. Specify below which is being quoted. If you are quoting cost per kit, specify the number of tests per kit in a separate attachment.

Shipping Terms: FOB is Destination. All costs for shipping, packaging and delivery must be included in the Cost per Test/Cost per Kit cost. No separate line item shall be accepted for shipping (freight), packaging and delivery.

Base Year: June 1, 2018 – May 31, 2019

Schedule

Base Year Total

Option Year 1: June 1, 2019 – May 31, 2020

Schedule

Option Year 1 Total

Option Year 2: June 1, 2020 – May 31, 2021

Schedule

Option Year 2 Total

Option Year 3: June 1, 2021 – May 31, 2022

Schedule

Option Year 3 Total

Option Year 4: June 1, 2022 – May 31, 2023

Schedule

Option Year 4 Total

ESTIMATED COST PER TEST/COST PER KIT TOTAL: _______________________________

ESTIMATED TOTAL AGREEMENT (BPA) VALUE: ____________________________________

ANALYZERS

The second analyzer must be a mirror backup.

The second analyzer does not have to be a mirror backup BUT it must be able to perform the same tests.

Page 1 of Page 1 of

B.3 STATEMENT OF WORK FOR COST PER REPORTABLE RESULT COAGULATION TESTING

1) SCOPE:

Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of its' contractor owned analyzers and peripherals for the generation of Coagulation Testing. Testing shall include ProTime (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (FIB), and D-Dimers for Oklahoma City VA Health Care System and Lawton/Fort Sill VA Community Based Outpatient Clinic (Henceforth known as OKCVAHCS); Eastern Oklahoma VA Medical Center in Muskogee, OK and Ernest Childers Community Based Outpatient Clinic in Tulsa, OK. Coagulation testing shall be conducted on a Cost per Reportable Result (CPRR) basis. A services component will also be included in the contract, to provide maintenance, repairs, upgrades, training and a Quality Control program. Equipment, supplies and services shall be required for a base year period with four one-year options for renewal. Coagulation CPRR shall be provided at:

1. Oklahoma City VA Health Care System, 921 N.E. 13th St., Oklahoma City Oklahoma, 73104

1. Lawton/Fort Sill VA Outpatient Clinic, Bldg. 4303 Pitman Street Fort Sill, Oklahoma, 73503

1. Eastern Oklahoma VA Medical Center, 1101 Honor Heights Drive Muskogee, OK 74401

1. Ernest Childers VA Outpatient Clinic, 9322 E 41st St., Tulsa, OK 74145

2) DEFINITIONS:

Cost Per Reportable Result (CPRR): Contractors are required to provide a price for each patient test that can be performed on its equipment (PT, APTT, FIB and D-DIMER). The per reportable patient test price shall include costs covering (a) equipment use, (b) all reagents, calibrators, controls, linearity samples, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs), (d) training for Government personnel, and (e) cost of shipping and handling of all reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories, uninterruptible power supply with line conditioner and all other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of test results. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

3) GENERAL REQUIREMENTS:

a) Offered models of clinical laboratory Coagulation instruments shall be capable of producing accurate and reproducible assays on 3.2% Sodium Citrate plasma specimens by established in vitro diagnostic methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

b) Primary Coagulation Analyzer- Base equipment offered to each VA laboratory listed herein will fully support the scope of their operations (minimal requirements) as defined in this solicitation. Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers (same manufacturer and same technology) may be required to meet the productivity specifications defined herein. In that instance, the additional analyzer(s) offered meeting the definition of a primary analyzer will be equivalent to a back-up analyzer (See definition below) and will replace the requirement for offering that category of equipment.

c) Back-up coagulation analyzer- Equipment required to support the operations of the laboratories in those cases when the primary analyzer is not operational/functional or meets the productivity specification required of the individual facilities. Operation software, hardware, and consumables must be comparable between large and small modules and back-up instruments. Back-up instruments must provide comparable results for references and ranges to primary instruments.

d) Offered equipment shall be new equipment. Remanufactured and discontinued models will not be accepted.

e) The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market.

f) The models being offered shall be in current production. Current production shall mean that the clinical laboratory analyzer model is being manufactured as new. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

g) An operator’s manual shall be furnished with each instrument supplied to VA and updates to manual shall be provided in a timely manner.

h) Editable electronic copy in CLSI (Clinical and Laboratory Standards Institute) format of operating procedures and related training and maintenance documents shall be furnished with each instrument supplied to the VA.

i) All proposed equipment must fit the existing space at the facility, without the need for renovation work. Small scale re-arrangement of furniture is acceptable. Fitting existing space shall include conforming to the current structural parameters of each lab, in each facility, in terms of delivery, installation and lab space. (I.e. equipment size, weight, packaged size for delivery, electrical/voltage).

j) Clinical Laboratory assays currently performed at the facility shall include, but may not be limited to the following assays.

i. PT, APTT, FIB AND D-DIMER

k) Pricing: The CPRR shall include all costs for:

i. Equipment use.

ii. All consumables, reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories and any other items required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result.

iii. All necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs.

iv. Training for facility personnel operating equipment.

v. Shipping and handling costs for all reagents, supplies, and consumables.

l) The awarded contractor is required to provide delivery, installation, set-up, validation and method comparison, including all supplies provided by the vendor, and decontamination, packaging and removal of equipment at completion of this agreement at no additional charge to the Government.

m) The awarded contractor shall provide yearly Lot Conversion studies to include therapeutic range establishment or confirmation of existing therapeutic range.

4) SYSTEM REQUIREMENTS

a) The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA), the Clinical and Laboratory Standards Institute (CLSI).

b) 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.

c) Accuracy of the barcode reading must have less than a 1% failure rate

d) Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently

e) Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric

f) Prioritization of STAT testing is required

g) Minimal Daily, Monthly and Periodic Maintenance

h) Ability to store and transmit records (at least 24 hours of instrument throughput) in case of interface outage

i) On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of one year for reagents (d-Dimer reagents may have 6 month expiration)/

j) Automated specimen handling/loading system

k) Minimal reagent preparation

l) Capability to store at least 500 patient results in database for immediate recall

m) Instrument must be approved by the Food and Drug Administration (FDA) and shall have the following:

i. Ability to monitor instrument performance.

ii. On Board reagent inventory system.

iii. Minimal carryover.

iv. Long calibration stability.

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

o) An on-board monitor/screen that is easily readable.

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

q) An uninterruptible power supply with line conditioner for each instrument provided.

r) An auto sampling system and auto-loader,

s) Primary 3.2% Sodium Citrate plasma tube sampling including different tube sizes and heights

t) Provide assayed Controls, Linearity samples covering the analytical measuring range of the instrument which are required every 6 months for all analytes due to a CAP requirement for maintaining assays and CLSI method validation to be provided by the contractor to validate the manufacturer’s claimed analytical measuring range.

u) Capability to detect out of range quality control.

v) On-board QC data management system with a minimum storage capacity of 4 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

w) Instrument throughput of that matches the average sample load of the facility.

5) INTERFACE REQUIREMENTS

a) 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

b) 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.

c) 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.

d) 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.

6) CONSUMABLE/REAGENT REQUIREMENTS

a) All consumable supplies (reagents, standards, controls, linearity samples, disposables, parts, accessories, etc.) required for the proper operation of the contractor's equipment and necessary to perform tests on the equipment shall be included.

b) In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the respective Lab Facility, Pathology and Laboratory Medicine Department, 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 Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

c) The contractor shall maintain on Government provided space a continuously stocked inventory of controls, calibrators, reagents, supplies, disposables, parts, accessories, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).

d) Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included 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.

7) MAINTENANCE, REPAIR AND UPGRADE REQUIREMENTS

a) A technical assistance center must be available to provide technologist support by telephone hot-line 24/7 days/week with a maximum call back response time of 1 hour with on-site service provided, not to exceed 24 hours following determination that site service is required.

b) Ability to provide equipment service on a 24-hour/day 7 days/week basis for hospital-based systems and on a 5 days/week basis for clinic-based systems.

c) Equipment repair response time shall be no more than 24 hours.

d) Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable his maintenance representative to receive such notification. The contractor shall be on-site at the facility to perform emergency repair service within twenty-four (24) hours after receipt of initial telephone notification of a malfunction.

e) Contractor shall provide technical support service to assist in troubleshooting and provide maintenance coverage Monday through Friday excluding holidays, 8:00am – 5:00pm CT.

f) In addition to above the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:

i. date and time notified;

ii. date and time of arrival;

iii. serial number, type and model number(s) of equipment;

iv. time spent for repair;

v. description of malfunction and repair; and

vi. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance and any other testing as needed.

g) During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance manufacturer’s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.

h) The contractor shall not leave a service call open pending verification that repairs are completed by the contractor’s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.

i) 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 applies to “system upgrades” that enhance the models of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade due to significant changes in the hardware operational capability, upgrade offered to commercial customers at no additional charge, upgrade to replace models of equipment no longer Contractor supported.

8) TRAINING REQUIREMENTS

a) On-site training (at respective VA Medical Center) and key operator training for at least 2 operators per site per year.

b) 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.

c) If on-site training is not available and contractor can only provide off-site training, then the off-site training program shall be paid for by the contractor and shall include the costs of airfare, transportation, and room and board for at least 2 operators per site per year.

9) CHARACTERIZATION OF WASTES

a) 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.

b) Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

c) The determination and description shall address the following:

i. Waste Toxicity

ii. Waste Ignitability

iii. Waste Corrosivity

iv. Waste Reactivity

v. Hazardous waste from non-specific sources (F-listed)

vi. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

vii. Solid Waste

viii. Exclusions

d) 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.

e) 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 CFR §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 CFR §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, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review.

f) 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: Please include TOTALS for each i) – xv).

i. Barium

ii. Cadmium

iii. Chromium

iv. Copper

v. Lead

vi. Mercury

vii. Nickel

viii. Silver

ix. Zinc

x. Arsenic

xi. Selenium

xii. Tin

xiii. pH

xiv. Flash point (to higher than 200F)

xv. BOD; biochemical oxygen demand

g) 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

10) TRANSITION PERIOD:

a) Within 30 days, the awarded contractor shall have all Coagulation Testing equipment and peripherals installed at the effected facility.

b) Within 60 days, of award the contractor shall complete all initial training of VA personnel in the operation, and maintenance of said equipment shall also be completed.

c) No later than 90 calendar days after award, the contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for equipment, supplies and services under the awarded contract.

d) Charges shall not apply no earlier than the first day of patient testing after all installation, training, and method validations have been completed. At this time, the awarded contractor shall have completed full transition of all equipment, supplies and services under this agreement and shall have full and sole responsibility for equipment, supplies and services under the awarded contract.

11) TERMS AND CONDITIONS:

a) If, for any reason, a contractor ceases testing of any Coagulation Testing assays, the contractor shall notify the VA contracting officer 60 days prior to the assays being discontinued.

12) LOCATIONS

Oklahoma City VA Health Care System 921 N.E. 13th St Oklahoma City Oklahoma, 73104 Lab Manager: Monique Lias-Moore, 405-456-5327 Hematology/Coagulation Supervisor: Jana Gausman, 405-456-5246

Lawton/Fort Sill VA Community Based Outpatient Clinic Bldg. 4303 Pitman Street Fort Sill, Oklahoma, 73503 Lab Manager: Monique Lias-Moore, 405-456-5327 Supervisor: Sal Gonzalez, 580-585-5778

Eastern Oklahoma VA Health Care System (aka: Jack C. Montgomery VA Medical Center) 1101 Honor Heights Drive Muskogee, OK 74401 Hematology/Coagulation Section Supervisor: Charles Kester, 918-577-3684

Ernest Childers Outpatient Clinic 9322 E 41st ST Tulsa, OK 74145 Lab Supervisor: Lana Ketenbrink, 918-260-7261 Lab Manager: Theresa Dawson, 918-577-3687

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

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

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

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

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

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt,…