36C25921Q0013 0003.docx

36C25921Q0013

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 04-09-2021 na 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village

CO

80111 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village

CO

80111 To all Offerors/Bidders

03-12-2021

X

X The purpose of this amendment is to reopen Solicitation # 36C25921Q0013. The solicitation is attatched in its entirety.

Ronnie R. Jones Contracting Officer

VA-VHA-2020-E9AB8090

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

36C259-21-AP-1465

36C25921Q0013 04-09-2021 Shawna Baumert 303-712-5721 04-26-2021

9 AM

MDT

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 X 334516 N/A X 36C554 Department of Veterans Affairs Rocky Mountain Regional VA Medical Center 1700 N. Wheeling Street Aurora CO 80045 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Submitted Electronically Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Contractor shall provide Chemistry and Immunochemistry Cost Per Reportable Result (CPRR) Services.

This solicitation is only open to Federal Supply Schedule Holders on GSA.

This is a FAR Part 8 procurement.

See CONTINUATION Page X X Ronnie R. Jones

VA-VHA-2020 E9AB8090

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

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

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

B.1.1.1. CONTRACTOR: Name:

B.1.1.2. GOVERNMENT: Shawna Baumert, Contract Specialist Department of Veterans Affairs Rocky Mountain Network NCO 19 Contracting 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 Telephone: 303-712-5721

FAX: 303-712-5850

E-mail: Shawna.Baumert@va.gov NCO19Services2@va.gov

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

B.1.3. GOVERNMENT INVOICE ADDRESS: Invoices shall be submitted in arrears:

c. Other [X] 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/Tungsten e-Invoice Setup Information: (877) 752-0900

1. OB10/Tungsten 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: Services required herein shall be for the following time period:

Base Year: May 24, 2021 through May 23, 2022 Option Year 1: May 24, 2022 through May 23, 2023 Option Year 2: May 24, 2023 through May 23, 2024 Option Year 3: May 24, 2024 through May 23, 2025 Option Year 4: May 24, 2025 through May 23, 2026

B.2 STATEMENT OF WORK Chemistry and Immunochemistry Cost Per Reportable Result (CPRR) Page 1 of Page 1 of Page 1 of Page 1 of

1. SCOPE:

Contractor shall provide all equipment, reagents, standards, controls for troubleshooting purposes only, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of its contractor owned chemistry analyzers and peripherals necessary for the generation of chemistry and Immunochemistry Cost Per Reportable Result (CPRR) services for the Rocky Mountain Regional VA Medical Center (RMRVAMC) located at 1700 North Wheeling St, Aurora, CO, 80045.

2. DEFINITIONS:

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

3. GENERAL REQUIREMENTS:

a. Offered models of clinical laboratory chemistry and immunochemistry analyzers shall be capable of producing accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods (see Proposed Rule by CMS 2/4/19 CLIA Proficiency Testing Regulations Related to Analytes and Acceptable Performance). Instrument 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.

· Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

· The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed at RMRVAMC within 60 days of issuance to the commercial market.

· The models being offered are in current production as of the date this offer is submitted. Current production shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

· Contractor furnished equipment shall perform satisfactorily at any laboratory temperature between 64- and 90-degrees Fahrenheit (18 and 32 Celsius) and relative humidity and altitude at the site of use.

· An operator’s manual shall be provided with each instrument supplied to RMRVAMC.

· Training for RMRVAMC personnel operating equipment

· The Contractor’s chemistry analyzers and related equipment shall conform to RMRVAMC existing chemistry and immunochemistry designated laboratory space.

b. Clinical laboratory assays currently performed at the RMRVAMC Pathology and Laboratory Medicine Services shall include, but are not limited to, the following assays.

c. Pricing: Contractors shall provide pricing for each test in accordance with the CPRR that can be performed on the quoted equipment.

If assay is not available on manufacturer’s equipment, third party reagents, controls, calibrators, and consumables shall be included in the contract to accommodate RMRVAMC’s current test menu.

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 requesting RMRVAMC facility site, in the most expeditious manner possible, without additional cost to the Government. The necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

d. Inventory Control Reagents Supplies and Disposable: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, supplies, disposables and any other material or commonly stocked parts 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).

e. Maintenance and Repairs:

(1) With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract for performance of CPRR services.

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

(3) The contractor shall be on-site at the VA facility to perform emergency repair service to testing and ancillary instruments within twenty-four (24) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide medical center maintenance coverage 24 hours per day, seven days per week including all Federal holidays. Contractor shall provide technical support service to assist in troubleshooting 24 hours per day, seven days per week including Federal holidays

(7) For preventative maintenance while instrument ‘A’ is undergoing maintenance, mirrored instrument ‘B’ shall be fully operational or else maintenance of instrument ‘A’ will be postponed until operational. While instrument ‘B’ is undergoing maintenance, mirrored instrument ‘A’ shall be fully operational or else maintenance of instrument ‘B’ will be postponed until operational. There shall always be one operational instrument at all times.

(4) Provide on-site contractor operator training for all personnel who will run instrument with training provided for all applicable shifts.

4. SPECIFIC INSTRUMENTATION AND EQUIPMENT REQUIREMENTS:

1) Contractor shall provide two mirrored chemistry and immunoassay analyzers and an automation line adequate for the test volumes of RMRVAMC. The automation line includes front end automation, two centrifuges with short cycle times and ability to function with different centrifugation profiles, refrigerated tube storage module, aliquotter with attached modules for push cap/screw cap , any recappers, resealers, decappers, desealers, bar code printers, computer command module, 2 printers, UPS, transformers and compressors for the functioning of the automation.

2) Space requirements: The chemistry and immunoassay analyzers, automation line, tube storage module, compressor (if needed), transformer(s) (if needed), uninterruptable power sources, and all other required equipment to make contractor equipment functional (also referred to as “peripherals”), shall conform to RMRVAMC’s designated floor space (41’6” x 22’ = 498”x 264” ), See attachment, in section D. There is a required 44” walkway clearance illustrated in yellow on the diagram that surrounds this space that must remain clear of equipment. No alteration of VA’s space will be allowed. No benchtops or tabletops will be moved to accommodate contractor equipment outside this rectangular space designated as 41’6” x 22’. Drains and the south pillar cannot be moved.

3) The refrigerated tube storage unit(s) shall be capable of holding at least 13,000 tubes.

· Rapid secondary access to tubes in a safe manner through a window or door is preferred, in case of the automation line being down.

4) The automation line and storage module shall accept the following tube types: 13 x75 mm, 13 x100 mm, 16 x 75 mm, 16 x 100 mm tubes.

5) Early detection and troubleshooting capability of unacceptable specimens (test and tube type (cap) mismatch) in the automation line is preferred as a new sample may be requested promptly saving valuable time.

6) Sample aliquotter for referral lab send outs shall be on the line and use disposable tips and have a module to recap reference lab send out tubes using screw caps or push caps

7) Laboratory Test Menu:

· RMRVAMC’s current test menu is attached, the performance ability of the following critical tests on the automation line is required, shortest assay times are preferred:

· Troponin with a rapid assay time

· Intra-operative PTH with a rapid assay time

· NT-Pro-BNP or equivalent with a rapid assay time

8) NT-Pro-BNP or equivalent should be available on the automation line and is preferred.

9) Biotin Interference in tests: No biotin interference is preferred in immunoassays. Biotin interference mitigation strategies for immunoassays are acceptable.

10) Engineering controls (design of consumables using color coding, container design etc. ) for reducing human error when loading consumables should be inherent in the system.

11) Consumables: The longest reagent lot on-board stability is preferred for chemistry analytes.

12) Consumables: The longest reagent lot on-board stability is preferred for immunoassay analytes.

13) Majority of immunoassay reagents should be liquid and ready to use, without the need for visual verification or adequate mixing before loading onto instrumentation.

14) Consumables provided by the contractor shall include reagents and calibrators, but the contractor is not required to provide controls.

15) Lab Information System/IT shall include:

· Data storage and back-up for failover

· Computer command modules with two printers and licenses for 6 other thin client computers for remote viewing in the laboratory.

· Instrument based software that predicts reagent usage based on testing data

· Automated rules based, repeat testing capability

· Automated rules based, reflex testing capability

· Lean process for test result validation and auto-verification that is compatible with the VA’s LIS (currently VistA).

· IT/Workflow consultation and implementation.

16) Misc. requirements:

· 24/7 phone and in person technical support

· Assistance with assay validation (performance of validation and collation of data in presentable form) to laboratory staff. This will include method correlation, AMR verification, Precision (within run and between run 5 days), HIL studies using readily available materials from BioRad or other contractors, Carryover studies for 3 analytes if disposable tips are not used.

· Assistance with input of assay parameters/technical data in the instrument software.

· Project management support during the install of the new automation line.

5. SPECIAL REQUIREMENTS:

In addition to the general and specific requirements for the Chemistry and Immunochemistry Cost-Per-Reportable Result stated above, the contractor shall provide equipment, peripherals and supplies meeting the following requirements, characteristics and capabilities:

Characteristics:

· Cost of auto-verification programming and validation covered in contract should the VA software change allow for this option during the duration of this contract.

· Detail time to STAT result from time sample is placed on instrument and exactly how the interrupted run is delayed.

i. System shall be an open system which can accommodate user-defined methods.

j. QC material shall be included for troubleshooting for all tests in use.

k. Peer QC review software program shall be included in the contract, with ability to automatically transmit QC data to QC contractor and shall provide real time peer QC comparison, with reports and electronic QC review.

Software:

· Look up capabilities for results on samples being processed.

· Ability to store calibration curves for at least two different lot numbers of reagents held on-board.

· Ability to perform automatic on-board dilutions of all sample types for out-of-range results.

· Ability to trigger automatic repeat testing of critical values.

· Ability to add additional tests to already programmed sample.

· Ability to load reagents while instrument is running.

· Ability to detect and alert operator to “short” samples.

· Ability to detect and alert operator to clotted samples.

· Ability to trigger reflex testing.

· Ability to alert user and/or automatically discard empty/expired reagent containers.

· Ability to provide STAT testing and perform calibration curves during routine runs without excess delay in analysis in progress.

· On-board sample inventory.

· Ability to manually repeat testing of specimens currently loaded on instrument.

· Software allows review of QC and patient results for single analyte to help in troubleshooting.

· Software upgrades should be automatic and include training if needed.

· Software is upgradeable (provide list of versions).

· Minimal screen changes when manually programming samples for testing.

· Desirable features of software include programmable rules for reporting, auto-verification, and reflex testing.

· Above software features can be accomplished by instrument software or middleware. If middleware is needed, include necessary hardware and software in contract and CPRR calculation.

· Ability to store and archive results and differentiate which instrument performed them for up to 2 years.

· Ability to differentiate which instrument performed the test if site has multiple instruments.

· Ability to order QC on multiple lots numbers of reagents.

· Ability to recall current and prior on-board reagent and calibration inventory with lot numbers and time in use.

· Software will hold patient result when QC is out of limits, until all QC issues have been resolved.

· Software will require new lots of reagent to be calibrated and QC performed before being able to report patient testing.

· If middleware is needed, the middleware has the ability to create calculations for tests result(s) when necessary.

e. Specimen inventory control software and supplies, to track completed samples in storage, priced in quote for those sites who desire it.

f. Equipment shall be versatile and provide efficient hardware capabilities.

· Analyzer performs both chemistry and immunochemistry testing (workstation consolidation for increased efficiency).

· High test throughput per hour.

· Quick time to first result.

· Analyzer accommodates multiple patient tube sizes.

· Accommodates direct testing from commercial serum/plasma transport tubes.

· Contractor shall supply short sample cup that fits inside primary tube to allow original primary barcode reading.

· Large reagent bay to accommodate all reagents for all analytes for on-board menu maximization (walk-away enhancement).

· Uninterruptible power supply (surge protection + battery backup) provided and serviced by contractor.

· Hardware upgrades shall be available as needed and include any necessary training.

· Laboratory has space for instrument and peripherals. Contractor shall provide plan for placement of new analyzer(s) prior to initial method validation and after when transitioning to new instruments. Plan shall be specific and accurately reflect available space at the RMRVAMC.

· For track systems, automation of centrifuge loading and unloading, tube de-capping and re-capping of samples, sample filing system and sample storage are available options.

· Track systems must be reliable with a low frequency of downtime. Contractor shall provide user statistics.

· All parts and items needed for maintaining and running track system covered in contract.

g. Equipment and software shall at a minimum, provide operator-friendly maintenance requirements.

· Routine maintenance takes minimal tech time.

· Routine maintenance, function checks and calibrations cause little or no delay to testing.

· Reliable technology used for electrolytes.

· Instrument troubleshooting is easy and straightforward.

· Instrument is connected via modem to the contractor hotline, which can view instrument status and remotely control troubleshooting process.

h. Electronic documentation of maintenance records with the ability to alert users when tasks are due.

Reagent and Standards: Convenient Reagent and Standard Use

· Extended calibration life for most analytes – little or to no daily/weekly calibrations.

· Automatic calibration of electrolytes.

· Liquid calibrators for most/all tests are preferred.

· Liquid reagents with very little or no reagent manual preparation for most/all tests before loading onto instruments is preferred.

· Enzyme verifiers available to periodically check performance of enzyme tests that lack standards.

· Reagents have prolonged shelf life and stability once opened/on-board.

· Various reagent sizes for large/small volume facilities.

· On-board reagent inventory.

· Instrument alerts operator to regents/consumables needed to complete testing.

· On-board reagent refrigeration.

· Contractor shall characterize each method and provide exact contractor guaranteed minimum linearity/AMR, CRR limits. Disclosure of methods with less than 3-point calibrators.

· As new methods are released for the instrument, the updates are automatically enabled promptly and at no cost to user.

· Advantage for minimum of 3-point calibration or verifiers for general chem. Reagents (accuracy enhancement, plus using alternate lot of calibrators can stand for bi-annual calibration verification and AMR validation required by CAP without added expense to user.)

· Provide values for calibrators.

QC Data Management: Versatile and convenient QC Data Management.

· Disk storage and/or submission of QC data for peer comparisons.

· Ability to view and print daily and monthly results, and Levy-Jennings graphs for our own data.

· Inter-laboratory peer comparisons forwarded monthly.

· Ability to store QC values for second lot number during crossovers.

· Ability to retain QC data from second lot number when put into use.

Invoicing: Invoicing: Test counts for invoicing by CPRR automated by modem or software.

b. Contractor shall provide a plan for transitioning services from the incumbent contractor to the newly awarded contractor. Contractor shall not exceed 60 days for installation. During this time, the VA primary operators shall be trained at the Contractor’s training site. Failure of the contractor to conform to this transition, installation, and training period shall be considered sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply.

c. Instrument and method validations by Contractor shall not exceed 90 days after installation of analyzers, with an extra month for validation of interfaces. During this time, Contractor shall provide fully editable electronic copies of all methods, instruments, operations, and maintenance procedures to be used for the preparation of site specific standard operating procedures (SOPs).

e. Billing by Contractor starts on the first day of patient testing after all installation, training, method and interface validations have been completed and accepted in writing by the Pathologist or Medical Director. At that time, the awarded contractor shall have completed full transition of all services under this agreement and shall have full and sole responsibility for services under the awarded BPA.

7. BUSINESS ASSOCIATE AGREEMENT:

The contractor awarded this BPA shall enter into a fully actuated Business Associate Agreement with the VA.

8. RECORDS MANAGEMENT:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

· 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.

· 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.

· 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.

· 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.

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

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

· 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.

· 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.].

1. 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.

2. Contractor shall be 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) shall to abide by Government and Agency guidance for protecting sensitive and proprietary information.

B.3 SCHEDULE

Base Year: May 24, 2021 through May 23, 2022 Rocky Mountain Regional VA Medical Center

Total Cost

Tox Screens

Base Year Estimated Cost: $

Option Year 1: May 24, 2022 through May 23, 2023 Rocky Mountain Regional VA Medical Center

Total Cost

Tox Screens

Option Year 1 Estimated Cost: $

Option Year 2: May 24, 2023 through May 23, 2024

Total Cost

Tox Screens

Option Year 2 Estimated Cost: $

Option Year 3: May 24, 2024 through May 23, 2025

Total Cost

Tox Screens

Option Year 3 Estimated Cost: $

Option Year 4: May 24, 2025 through May 23, 2026

Total Cost