36C25720Q1144.docx

36C25720Q1144

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 ATTA

CHED

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. SIGNAT

URE 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

504-20-4-044-0121 36C25720Q1144 08-25-2020 Robyn Nussbaum 806-354-7830 09-04-2020 16:00 00504 00504 Department of Veterans Affairs Contracting Section 6010 Amarillo Blvd W Amarillo TX 79106 X X Y 334516 1000 Employees

NET 30

N/A X Department of Veterans Affairs P&LMS Section Amarillo Blvd W Amarillo TX 79106 00504 Department of Veterans Affairs Contracting Section 6010 Amarillo Blvd W Amarillo TX 79106

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices

(877) 353-9791

(512) 460-5540 See CONTINUATION Page See Section B for Statement of Work and Price/Cost Schedule.

**NOTE: All questions must be submitted in writing to the Contract Specialist Robyn Nussbaum at robyn.nussbaum@va.gov by COB August 31, 2020.

See the provision at 52.212-2 for evaluation criteria. The attached Pricing sheet must be completed and return with proposals. Should offerors wish to include different prices for option years, separate price lists should be included with proposals.

See CONTINUATION Page X X X Contracting Officer 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 36C257 00504 Department of Veterans Affairs Contracting Section 6010 Amarillo Blvd W Amarillo TX 79106

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.

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

I. SCOPE

The Amarillo VA Health Care System (AVAHCS), Pathology and Laboratory Medicine Service (P&LMS), requires an upgrade for the two (2) Radiometer ABL80 COOX analyzers currently in use at the Amarillo, TX location. This upgrade shall constitute a Cost Per Reportable Result (CPRR) contract with indefinite delivery and indefinite quantity (IDIQ) for supplies, consumables, controls, calibrators and Service for both analyzers. (Depot service is not acceptable). This will also require the addition of the one (1) Quality Control Program Unit with 2 analyzer hookups and the trade in of the two (2) Radiometer ABL80 COOX analyzers that were purchased in 2016 to offset some of the cost. The minimum estimated yearly volume and a yearly maximum estimated volume per location is indicated in the table below under Section II. General Requirements and the location of install is to be at the following address:

For the Amarillo location the CPRR contract period of performance will begin at award and will consist of delivery, installation, and validation. Support and Maintenance, and Consumable Supplies will consist of IDIQ request for a base year and up to four (4) possible option years to be exercised at the government’s discretion.

II. GENERAL REQUIREMENTS

The contractor shall provide equipment suitable to provide the AVAHCS with the ability to accurately and efficiently analyze patient arterial blood gas specimens without the mitigating problem of interfering factors (i.e. Benzalkonium), no replaceable membrane kits, no manual manipulation of specific electrodes, and must be capable of performing the following tests:

Amarillo Location Quotes shall be based upon the Estimated Annual Volume.

ANNUAL VOLUME

III. CONTRACTOR RESPONSIBILITIES

A. The contractor shall provide all tools, equipment, technical information, travel, and personnel for proper installation of the analyzers. This includes 1 external printer per location, 2 Uninterruptable Power Supplies (UPS) per analyzer, the required number of interface boxes and surge suppressors. 1 Quality Control package with the capability of hooking up 2 analyzers and has the ability to produce Levy-Jennings graphs and to provide monthly peer data for the external controls.

B. The quality control package shall consist of software to be compatible with the with the hospital environment, installation, device management/compliance, operator management, competency management, flexlink, printer, access for 2 analyzer hookups, and sample processing modules.

C. The contractor shall be able to provide all reagents, supplies, consumables (other than printer ink and paper), assay controls, calibrators, and parts necessary for quality performance with the understanding that this is procured as IDIQ.

D. The contractor shall encompass all costs associated to perform quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS).

E. The contractor shall quote the VA a Food and Drug Administration (FDA) approved system. The FDA approval must be for clinical performance, not for research only.

F. The contractor shall provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. The system must have documented evidence that there is no reagent carryover interference with other onboard assays.

G. The contractor shall provide interpretation of the raw data as part the installation.

H. The contractor shall list the reagents, controls, and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution.

I. The contractor shall list the reagents/waste receptacles requiring treatment before disposal.

J. The contractor shall also list all reagents/waste that is considered above normal toxicity and/or hazard.

K. The contractor shall not (at this time) include remotely monitored maintenance or troubleshooting software programs that electronically transmits critical operational and administrative information from instruments to our internal systems via a secure Internet connection. This option may be added at a later date. This secure, encrypted technology will enable transfer of key logs, report generation, and remote services developments. It should also offer the potential to improve inventory management by enhanced troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review.

IV. EQUIPMENT REQUIREMENTS

A. The specifications as set forth in this section are the minimum requirements of the government. The quoted equipment shall meet or exceed the minimum requirements and shall be windows based.

B. All equipment to be supplied shall be new and of the most current model of a standard product of a manufacturer of record that will accommodate the minimum requirements. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of the items of equipment and which:

1. Maintains a factory product line.

2. Maintains a stock of replacement parts for the item.

3. Maintains engineering drawings, specification sheets, and operating, maintenance, and service manuals.

4. Has published and distributed descriptive literature and specifications for the equipment.

5. Has documented evidence that there is no reagent, no interference factors (if any), or sample carryover interference with other onboard assays. Evidenced proof shall be provided upon request.

6. No interfering factors (e.g. Benzalkonium) will be acceptable.

7. No replaceable membrane kits will be acceptable.

8. No manual manipulation of specific electrodes will be acceptable.

9. No manual specialized procedures to perform due to interfering factors will be acceptable.

10. Analyzer must employ ultrasonic hemolyzation technology within the Co-Oximeter to eliminate interference, avoid clots and prevent deposits (maintenance free).

11. Analyzer must have air-in sample detection.

12. Analyzer must have automated, on board calibration, and one-point calibration must be automatically performed with each test sample.

13. Analyzers must have built-in video tutorials with audio

14. Analyzers must be able to provide an Audit trail

15. The analyzers must have a comprehensive Quality Control (QC) Program, which complies to Individualized Quality Control Plan (IQCP) Standards (2016) or shall have documentation excluding the analyzer from having to conform to IQCP standards.

16. The QC program shall include the following minimum options:

a. QC files with automatic statistical calculations of mean and standard deviation of individual lots with data storage.

b. The ability to perform external quality control evaluation on a daily basis as well as internal quality controls at prescribed intervals while being able to produce upon request daily and monthly Levy-Jennings graphs in real time.

c. Ability to view and print daily and monthly internal QC results in the form of Levy-Jennings graphs in real time.

d. Ability to view and print daily and monthly external QC results in the form of Levy-Jennings graphs in real time.

e. The ability to view and print past daily and monthly internal and external Levy Jennings graphs.

f. The ability to provide statistical data for peer group evaluation data on a monthly basis.

g. On-line and real time documentation of out of range internal and external QC.

h. Internal and external QC material acceptance criteria built in the QC program to be able to be manually edit accordingly to package inserts of new lot numbers of QC material.

i. QC reports must have documentation for all anlaytes listed in SOW. (Refer to section IV. J. 1-4)

j. Patient reports must have documentation for all analytes listed in SOW (Refer to section IV. J. 1-4)

C. Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime. Must have ability to backup and store patient data on external media.

D. Equipment shall have accurate capability of monitoring reagent usage.

E. Bi-directional, bar coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Vista hospital information system/and or Data Innovations middleware system for real time data transmissions.

F. Instrument LIS physical connection and translation (drivers). Must be compatible with Data Innovations Technologies system (DI), Vista, and DI Information systems. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer.

G. The total equipment footprint, when installed, must not negatively impact the functionality/ operations of the Pathology & Laboratory Service or Respiratory services; nor will it require significant and/or costly infrastructure changes. The analyzers shall not exceed the following specifications (size dimensions must be reasonably close due to the space requirement allotted to the analyzers):

1. Width: 10 inches

2. Height: 18inches

3. Depth: 15 inches

4. Weight: 20 pounds

5. Operating Environment: 12-28 degrees Centigrade

6. Altitude: 7513 feet above sea level

7. Power: 100-240 VAC, 50/60 Hz, 130

8. Thermostat control: 37.0 degrees Centigrade +/- 0.2 within 10 seconds

H. Arterial Blood Gas analyzers must meet the following specifications:

1. Must meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2. Sufficient capacity to meet the volume and service demands of a maximum of 700 samples/year for the Amarillo location.

3. The analyzer must be able to perform testing on low volume specimens down to 1 ml of sample or less.

4. The analyzer must be able to perform testing without specialized features/procedures to eliminate interfering factors (if any).

5. Automated sampling system.

6. System shall accept blood and other body fluids.

7. System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency (bar code scanner).

8. System shall have a design that removes the possibility of reagent or sample carryover.

9. System shall be a closed system with no maintenance to specific electrode assemblies or the warranted replacement of membranes on the electrodes.

10. System shall have automated Barometric pressure corrections.

11. System shall have sample temperature corrections (for patients drawn in hypothermic situations as in surgery)

12. System shall have a printer with capability of printing a chartable patient report.

13. System shall have the use of ultrasonic hemolyzation technology.

I. Uninterruptible Power Supply (UPS) for each of the analyzers as well as for the quality control program unit, J. Must be able to perform assays listed below:

1. Arterial Blood gas analysis (pH, pCO2, PO2, O2Sat, O2CT, HCO3, BE, FIO2, Na, K)

2. Ionized Calcium

3. Carboxyhemoglobin

4. Optional testing: Chloride, Total CO2, Glucose, Lactate, Hemoglobin, Hematocrit, Ionized Magnesium and Methemoglobin.

V. DELIVERY/INSTALLATION

A. Delivery and installation of the analyzers shall be provided to:

Amarillo VA Health Care System

Attn: Brenda Brock, Laboratory

B. The government will prepare the site for installation.

C. Installation will be completed within thirty (30) calendar days after date of award.

D. The performance period shall commence on the date of installation.

E. The contractor shall provide installation, start-up assistance and operator instructions and one (1) operator/maintenance/service manuals

F. The vendor shall provide, at no cost to the Government, at installation/set-up and when bringing new tests online, a technical support specialist who shall perform all validations studies including:

1. Start-Up Reagents

a. The vendor shall provide all reagents, calibrators, controls, linearity material, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish equipment/analyzers for operation, for performance of acceptance testing at no additional charge to the Government.

b. This applies to all equipment/analyzers as well as additional or replacement equipment/analyzers placed under the terms and conditions of the contract.

2. Installation/set-up

a. Installation, startup assistance, and all validation studies of the three (3) equipment/analyzers shall be completed no later than 90 days after date of award.

b. The performance period shall commence on the date of installation. Correlation Studies (evaluation/comparison data sufficient to satisfy CAP standards).

c. Normal Range (reference range), accuracy, and recovery studies must be performed using samples representative of the patient population being tested. Reference range assessment must be performed for each lab.

d. Verification of reference intervals shall use one of the following protocols:

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 sued to verify the manufacturer range. Any apparent outliers shall be excluded from the reference range and new specimens obtained to provide 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 range must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be sued 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, one of the two above mentioned protocols must be performed.

4) Precision studies shall be performed using 10 normal and 10 abnormal control material. Intra-VISN facility variations should be kept to an absolute minimum (+/- 5% of the target value).

5) Method comparison with current equipment/analyzers shall be at the expense of the vendor and shall be consistent with current CLSI guidelines and related documents; CAP standards, and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include whole blood, serum, plasma, urine, and all body fluids (as applicable).

6) Analytical Measurement Range (AMR)(linearity) studies shall be performed on proposed equipment/analyzer for each analyte to validate the reportable range Calibration verification studies per CAP HEM.36001 Limit of detection/AMR. A minimum of 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire AMR range shall be required and performed.

7) Sensitivity studies may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.

8) Specificity studies shall include a review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

9) Carryover studies for reagents and samples shall be successfully completed by the vendor on all equipment/analyzers during installation/set-up. These studies shall be performed using either vendor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge to the Government.

10) Vendor shall provide interpretation and all statistical analysis of raw data for each equipment/analyzer installed and provide a hard copy of data in an organized, clearly comprehensible format.

11) Vendor shall provide on-site education and instrument training during installation and when there is an update to the equipment. Staff training is to include all shifts at designated times defined per facility. Training is to include basic operation, quality control, interpretation of results, reporting results, required user performed maintenance, and troubleshooting. Documentation of this training shall be completed for all trained staff before leaving site following installation at each facility.

12) Assist with any methodology problems and questions. This service shall be available 24hours per day, 7 days a week, and 365 days a year including holidays.

VI. TRAINING

A. The contractor shall provide in-depth training for two (2) key operators on usage of the arterial blood gas analyzers and all quality control programs.

B. The contractor shall provide on-site training in the Amarillo laboratory to approximately twenty (20) staff members operating the analyzers (this will include Respiratory and the Laboratory employees). Training will be completed during and upon completion of validation.

C. The contractor shall provide one (1) hard-copy (paper or CD) Operator’s Manual per analyzer per location site.

VII. SERVICE AND MAINTENANCE

A. Instrument support services shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8:00 a.m. – 5:00 p.m. CST). The support service shall follow-up all down time notification with a telephonic response to the main laboratory telephone number 1-806-354-7870, within one (1) hour after receipt of notification. Depot service is not acceptable.

B. The contractor shall provide assistance to the user in setting up and maintaining/trouble shooting user-defined assays as additional tests are brought in-house.

C. The downtime of any one analyzer shall not exceed 24 hours; therefore, the contractor shall provide a twenty-four hour/seven-day per week, toll free, service hotline with technical support.

D. The contractor shall supply engineering controls if necessary, for any heat, humidity, or noise issues that may result from use of the proposed system (fans to circulate air, desiccant packs for reagent to control humidity, headphones in case the analyzer is too loud).

E. The contractor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).

F. The contractor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. The contractor shall indicate which tasks are user level and which are service level.

G. For reagents with hazardous constituents, the contractor shall provide a mechanism for the Laboratory to meet local discharge requirements. The contractor shall supply information regarding any hazardous chemicals.

H. The contractor shall provide one (1) maintenance manual per analyzer and one (1) service manual for Bio Medical Engineering either in hardcopy or CD.

VIII. CONSUMABLE SUPPLIES

A. Consumable supplies will be IDIQ for this procurement with the ability to sequester lot numbers in abundant supply. Consumable supplies needed to produce the estimated annual volume (see 1. General Requirements) and shall include the following:

1. Printer paper, 60 rolls total per year (or equivalent to process estimated annual testing volume) for both analyzers.

2. Linearity Verification Kit 20-25 vials total per year (or equivalent to process estimated annual testing volume).

3. Reagent Pack/Solution Pack/Cartridge Pack, 26 -30 packs total per year (or equivalent to process estimated annual testing volume) per location site.

4. Hemoglobin Calibration (if required), 4-6 vials total per year (or equivalent to process estimated annual testing volume) per location.

5. Tri Level (H, N, L) External QC material to be available for any reagent change and/or to follow up with troubleshooting by staff or by service representative for QC failures. The quantity required is to be equivalent to the process of the estimated maximum annual testing.

6. The majority of the supplies are to be stored at room temperature (due to constraints of refrigeration space at the customer’s facility).

IX. OTHER

A. Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria satisfactorily to the user.

B. Vendor shall notify the Bio-Medical department for removal the hard drive on any trade in analyzers and turning it over to the VA for destruction prior to removal of any analyzer.

C. The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems or any other product issues. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

D. In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor'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 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

E. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer

F. This contract should assist the Amarillo VA Health Care System to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals:

1. Benzene

2. Chloroform

3. Methyl ethyl ketone

4. Methyl isobutyl ketone

5. Tetrachloro-ethylene

6. 1,1,1-Trichloro-ethane

7. Trichloro-ethylene

8. Lead

9. Nickel

10. Carbon tetrachloride

11. Dischloromethane

12. Toluene

13. Xylenes

14. Cadmium

15. Chromium

16. Cyanide

17. Mercury

X. INTERFACE

A. Transfer of data is bidirectional and will occur in the following manner:

VISTA

(LIS)

DATA INNOVATIONS

INSTRUMENT

B. The following data fields will be collected:

C. Data is transferred from VISTA to a Data Innovations Secure Network Interface (SNI) device, which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format.

D. Patient testing is performed by Amarillo VAHCS Respiratory department staff and the Pathology & Laboratory Medicine Service staff using appropriate procedures, to access and verify codes.

E. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system.

F. The above Protected Patient Information (PPI) will stay on the instrument’s hard drive for about one month and then will be “written” over by new patient data. At the end of the contract the hard drive and any other data storing devices will be removed from the instrument and be taken to IRM for disposal.

XI. SITE VISIT

A. Site-visits shall not be scheduled or conducted without the coordination of the Contract Specialist.

B. Contact the Contract Specialist for more information.

XII. NORMAL WORKING HOURS & ACCESS TO SITE

A. The Contractor Repair Service Technician shall check-in with the AVAHCS Police Service before proceeding to the Laboratory Department. This check-in is mandatory.

B. The Contractor shall schedule on-site services with the COR during normal working hours between Monday and Friday, 8:00 a.m. and 5:00 p.m., local time, excluding Federal Holidays. Work outside of Normal Business Hours is not authorized.

C. Legal Holidays Observed:

1.

2. Please note that holidays falling on Saturday will be observed on the preceding Friday;

holidays falling on Sunday will be observed on the following Monday.

XIII. PERIOD OF PERFORMANCE

A. Base Year 10-1-2020 – 09/30/2021 B. Option Year 1 10-1-2021 – 09/30/2022 C. Option Year 2 10-1-2022 – 09/30/2023 D. Option Year 3 10-1-2023 – 09/30/2024 E. Option Year 4 10-1-2024 – 09/30/2025

XVI. INFORMATION

A. The contractor shall submit all invoices in arrears.

B. Payment will be made by VA FSC, Austin, Texas 30 days after receipt of a proper invoice.

C. General information to include on invoices:

1. Submission of a proper invoice including facility name, address, and phone number.

2. Type of service performed.

3. Date(s) of service or Period of Performance

4. Purchase Order number

5. Price

XV. EXECUTION

A. All work shall be performed in a safe and efficient manner.

B. The contractor shall assure its processes do not create an unclean or unsafe environment for the AVAHCS and do not damage or destroy government property.

C. The service portion of this requirement is exempted from the Service Contract Labor Standards

XVI. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS

A. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

B. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

C. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

D. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

E. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

F. The Government Agency owns the rights to all data/records produced as part of this contract.

G. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

H. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

I. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

J. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

XVII. LICENSING/ACCREDITATION SECURITY /CONFIDENTIALITY

A. The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance.

B. Personnel assigned by the Vendor to perform these services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

C. "The C&A requirements do not apply, and that a Security, Accreditation Package is not required.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Contractor shall provide reagents and supplies for the ABL 80 COOX arterial blood gas analyzers in Chemistry Department for Respiratory Service in accordance with the Statement of Work.

Contract Period: Base POP Begin: Date of Award/Effective Date POP End: 09-18-2021

Contractor shall provide reagents and supplies for the ABL 80 COOX arterial blood gas analyzers in Chemistry Department for Respiratory Service in accordance with the Statement of Work.

Contract Period: Option 1 POP Begin: 09-19-2021 POP End: 09-18-2022

Contractor shall provide reagents and supplies for the ABL 80 COOX arterial blood gas analyzers in Chemistry Department for Respiratory Service in accordance with the Statement of Work.

Contract Period: Option 2 POP Begin: 09-19-2022 POP End: 09-18-2023

Contractor shall provide reagents and supplies for the ABL 80 COOX arterial blood gas analyzers in Chemistry Department for Respiratory Service in accordance with the Statement of Work.

Contract Period: Option 3 POP Begin: 09-19-2023 POP End: 09-18-2024

Contractor shall provide reagents and supplies for the ABL 80 COOX arterial blood gas analyzers in Chemistry Department for Respiratory Service in accordance with the Statement of Work.

Contract Period: Option 4 POP Begin: 09-19-2024 POP End: 09-18-2025

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(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, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the…