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SERVICE - Coagulation Analyzer Reagent Lease Federal contract opportunity
Solicitation number
36C24718R0379
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 7

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36C24718R0379 FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 N SERVICE - Coagulation Analyzer Reagent Lease Solicitation posted 2/15/2018 & closed 2/26/2018 with one 36109-3798 36C24718R0379 03-15-2018 N 339112 Department of Veterans Affairs Central Alabama Veterans Health Care 215 Perry Hill Road Montgomery AL 36109-3798 Same as Contracting Office Same as Contracting Office Benford Brundage Benford.Brundage@va.gov

COAGULATION ANALYZER REAGENT LEASE

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 and/or 8.4, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will also be attached.

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. All proposals must be received prior to 4:00pm EST on March 15, 2018. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. NAICS code is 39113, Medical and Surgical Instruments Manufacturing; size standard 1,000 employees.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-72 effective January 30, 2014.

Please see attached RFQ document 36VA247-18-R-0379 for requirements.

Potential vendors are to complete the attached RFQ document and submit an itemized quote as well as submit sufficient supporting documentation which details product specifications. This supporting documentation will be used to determine whether or not the quoted items meet the requirements of the solicitation.

Information about current or previous vendors providing this/these or similar services such as; Contract Information, Vendor Name, Contract Number, Pricing, etc. WILL NOT be provided to potential bidders.

Vendors must complete RFQ in order to be considered for award, A QUOTE OR ATTACHMENT WILL NOT SUFFICE. This is a brand name or equal procurement. Only one award will be made to one vendor that can provide all items/services at the LOWEST PRICE TECHNICALLY ACCEPTABLE.

All questions must be addressed by email no later than 36 hours prior to the closing date.

Please provide pictures and specifications if you are not offering exactly what the government is requesting. All quotes must include shipping, installation and all other associated fees, (if required). See statement of work and other attachments for more detail if included.

Quotes are due no later than 4:00 PM EST, March 15, 2018. Telephone calls will not be accepted. All quotes are to be sent electronically to Benford.Brundage@va.gov.

INSTRUCTIONS FOR COMPLETING RFQ / SF 1449

1) Please acknowledge if your firm is a SERVICE DISABLED VETERAN OWNED SMALL BUSINESS, VETERAN OWNED SMALL BUSINESS or NON-VETERAN OWNED SMALL BUSINESS in block 17a on the first page of the SF1449/Solicitation.

2) Please provide pictures and specifications if you are not offering EXACTLY what the government is requesting. If you are offering the EXACT ITEMS/SERVICE/SUPPLIES being requested by the government, please verify and/or state that fact in the on page one (1), block 19 of the SF1449/Solicitation.

3) Information about current or previous vendors providing this/these or similar services such as; Contract Information, Vendor Name, Contract Number, Pricing, etc. WILL NOT be provided to potential bidding vendors.

4) Review Statement of Work and Other Attachments, (if applicable), for DETAILED INFORMATION.

5) Per the solicitation, your firm MUST COMPLETE THE ATTACHED RFQ and email completed document back to this office by the close of award CST in order to be considered for award. A standard quote will not suffice.

SF 1449 sections for Vendor Completion – Section 17a – Vendor Information Section 26 - Total Amount of Bid/Offer Section 30a-c – Vendor name, signature and date Section B. (Cost/Price Schedule) section for Vendor Completion – Unit Price – Unit Price for each separate line item Amount – Quantity multiplied by Unit price by each separate line item Grand Total – Total aggregate amount of all line items

I have provided a SAMPLE of how to complete Section B.3 – The Price/Cost Schedule below:

B.3 PRICE/COST SCHEDULE

Item Information

Item No. Description Quantity Unit Unit Price Amount

1
Widget A
1.00
EA
___$300.00_________
___$300.00______
2
Widget B
2.00
EA
___$500.00________
___$1,000.00____
3
Installation
1.00
JB
___$400.00_________
___$400.00______
4
Annual Service
4.00
JB
___$200.00_________
___$800.00______

GRAND TOTAL $2,500.

The B.3 Price/Cost Schedule above is a SAMPLE ONLY

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

619-18-3-7113-0011 36C24718R0379 03-12-2018 Benford Brundage x2436 03-15-2018 4:00pm EST Department of Veterans Affairs Central Alabama Veterans Health Care 215 Perry Hill Road Montgomery AL 36109-3798 X Y 339112 1000 Employees N/A X Department of Veterans Affairs

CAVHCS VA MEDICAL CENTER

ATTN: WAREHOUSE

215 PERRY HILL ROAD

MONTGOMERY AL 36109

10N7/NLO

Department of Veterans Affairs Network Logistics Contracting Office 501 Green Street Hatcher Building, Suite 2 Augusta GA 30904-6285

Department of Veterans Affairs Financial Services Center

FSC-104

PO Box 149971 Austin TX 78714-8971

COAGULATION ANALYZER REAGENT LEASE FOR THE CENTRAL

ALABAMA VETERANS HEALTHCARE SYSTEM TUSKEGEE/MONTGOMERY, AL

THIS IS AN UNRESTICTED PROCUREMENT

THIS IS A BRAND NAME OR EQUAL PROCUREMNT

ONLY ONE AWARD WILL BE MADE TO ONE VENDOR THAT PROVIDE ALL

ITEMS/EQUIPMENT AT LOWEST PRICE TECHNICALLY ACCEPTABLE.

ACTION MAY BE SOLE SOURCED TO ONE VENDOR

VENDOR'S QUOTE MUST INCLUDE ALL ASSOCIATED FEES: SHIPPING,

INSTALL, DELIVERY, ADMIN, ETC. IN FINAL PRICE/COST.

INSTALLATION IS NOT REQUIRED UNLESS SPECIFICALLY STATED.

THIS RFQ MUST BE COMPLETED BY THE VENDOR IN ORDER TO BE

CONSIDERED FOR AWARD. A VENDOR BID/QUOTE WILL NOT SUFFICE.

SEE BID INSTRUCTIONS INCLUDED IN THIS RFQ.

X X

BENFORD C. BRUNDAGE

Contract Specialist Table of Contents

B.3 PRICE/COST SCHEDULE3
SECTION A4
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS4
SECTION B - CONTINUATION OF SF 1449 BLOCKS6
B.1 CONTRACT ADMINISTRATION DATA6
B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)7
B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)7
B.4 PRICE/COST SCHEDULE28
ITEM INFORMATION28
SECTION C - CONTRACT CLAUSES30
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017)30
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)36
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)36
C.4 52.237-3 CONTINUITY OF SERVICES (JAN 1991)36
C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)37
C.6 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)38
C.7 VAAR 852.273-76 ELECTRONIC INVOICE SUBMISSION (Interim - October 2008)38
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)39
C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)39
C.10 52.216-18 ORDERING (OCT 1995)46
C.11 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2016)46
C.12 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—SYSTEM FOR AWARD MANAGEMENT (JUL 2013)48
C.13 52.232-34 PAYMENT BY ELECTRONIC FUNDS TRANSFER—OTHER THAN SYSTEM FOR AWARD MANAGEMENT (JUL 2013)49
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS53
SECTION E - SOLICITATION PROVISIONS84
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017)84
E.2 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV 2017)88
E.3 52.216-1 TYPE OF CONTRACT (APR 1984)104
E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)104

Page 1 of

Page 1 of

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247 BENFORD BRUNDAGE

Department of Veterans Affairs
Central Alabama Veterans Health Care
215 Perry Hill Road
Montgomery AL 36109-3798

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

[X]52.232-34, Payment by Electronic Funds Transfer -
Other than Central Contractor Registration, or
[]52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[x] In arrears

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be mailed to the following address:

Department of Veterans Affairs
Financial Services Center
FSC-104
PO Box 149971
Austin TX 78714-8971

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

AMENDMENT NO DATE

DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided below:

DUNS #___________________________________

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HubZone Small Business Concerns. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

Page 1 of Page 1 of

STATEMENT OF WORK

COAGULATION SYSTEM LEASE – 619-18-3-7113-0011

1.GENERAL INFORMATION
1.1.INTENT: It is the intent of the Department of Veteran Affairs at Central Alabama Veterans Health Care System (CAVHCS) to establish a Contract for Automated Coagulation Instrumentation. The Government will award a CPT CONTRACT to a single Contractor for Automated Coagulation Instrumentation. Contractor agrees that additional tests/reagents/instrumentation may be added to the CONTRACT as new technology becomes available on the market and added to the base FSS contract. The C&A requirement do not apply and a Security Accreditation Package is not required.
1.2.PRICES AND TERMS: CAVHCS will provide an estimated volume by test as reflected in Attachment A. The Government estimates the volumes per location as listed in Attachment A, but does not guarantee volumes as listed; they are estimates ONLY.
1.3.TERM OF AGREEMENT: This will be a single award, firm-fixed price CONTRACT with one base year and four, one year options. CAVHCS intends to establish the base year of the agreement for the period of 4/1/2018 through 9/30/2018.
2.DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK
2.1.SCOPE OF PROCUREMENT:
2.1.1.The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).
2.1.2.Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.
2.1.3.If Contractor offers a family of analyzers, a CAVHCS technical evaluation panel will determine if instrumentation proposed meets needs of using facility.
2.1.4.Equipment shall be acquired for each of the clinical laboratories located at the CAVHCS facilities listed in Attachment A.
2.1.5.The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.
2.1.6.Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.
2.2.DEFINITIONS:
2.2.1.Cost per Patient Reportable Result (CPRR)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.
2.2.2.Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.
2.2.3.Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.
2.2.4.Parameter definitions-
2.2.4.1.PT- Prothrombin Time
2.2.4.2.APTT-Activated Partial Thromboplastin Time
2.2.4.3.INR- International Normalized Ratio
2.2.4.4.ISI- International Sensitivity Index
2.2.4.5.Click here to enter text.
2.3.TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes.
2.4.GENERAL REQUIREMENTS:
2.4.1.Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.
2.4.2.(Applies only if selected) Back-up Analyzer(s)- Equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back-up performance are listed in Attachment A.
2.4.3.Contractor shall provide quality control material at a minimum of two levels; normal and elevated/abnormal levels.
2.4.4.All reagents, controls, calibrators, and normal donor plasma (for annual lot changes) will be of the same lot number for all users. Lot numbers will be in use at least twelve (12) months. All sites covered under this CONTRACT will convert to the new yearly lot number within 2 months of each other.
2.4.5.Assayed control plasma for PT and APTT are the preferred products to assess test quality. If assayed controls are not offered/available, the Contractor shall either:
2.4.5.1.Furnish assayed control plasmas to be run concurrently until a range can be established for the unassayed material.

2.4.5.2. Provide documented peer review of unassayed control data.

2.4.6.The product information must specify an appropriate ISI for the instrument and reagent lot number combination.
2.4.7.The ISI value for PT reagents must be between 1.0-1.3. The variance of the ISI value between reagent lots must not exceed 0.2.
2.4.8.Electronic barcode technology must be used to enter the ISI value.
2.4.9.Documentation must be provided regarding the effect of lupus anticoagulants in the therapeutic monitoring of warfarin.
2.4.10.Interference of heparin in the PT reagent must be minimal.
2.4.11.Operational Features- The instrumentation offered shall have the following:
2.4.11.1.The capability of performing analysis on 100% of the tests listed in Attachment A.
2.4.11.2.Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.
2.4.11.3.Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.
2.4.11.4.A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.
2.4.11.4.1.The accuracy of the barcode reading must have less than a 1% failure rate.
2.4.11.4.2.Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.
2.4.11.4.3.Equipment must accept, at a minimum, BARC characters in specimen identifier that is alphanumeric.
2.4.11.5.Ability to prioritize STAT testing without compromising existing programmed testing. Continuous operation without interruption to workflow for adding samples, reagents, or cuvettes. This allows the user to walkaway and not monitor the system during testing.
2.4.11.6.Minimal daily, monthly, and periodic maintenance.
2.4.11.7.Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.
2.4.11.8.Capability to store a minimum of 4000 patient records in a database for immediate recall.
2.4.11.9.Ability to accept various types of sample containers.
2.4.11.10.Ability to handle lipemic or icteric samples.
2.4.11.11.An on-board refrigeration system for reagents.
2.4.11.12.Minimum twenty-four (24) hour on-board stability of PT and APTT reagents.
2.4.11.13.Minimum eight (8) hour stability of quality control (QC) material.
2.4.11.14.Capability to detect out of range quality control.
2.4.11.15.Ability to automatically program the performance of QC testing.
2.4.11.16.On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 12 months for reagents.
2.4.12.Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:
2.4.12.1.On-board QC data management system with a minimum storage capacity of QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.
2.4.12.2.Ability to monitor instrument performance.
2.4.12.3.On board reagent inventory system.
2.4.12.4.Minimal carryover.
2.4.12.5.Long calibration stability.
2.4.12.6.Liquid ready to use PT, PTT and D-Dimer reagent
2.4.12.7.Minimal reagent, calibrator, and control preparation.
2.4.12.8.No specimen pre-treatment required for PT and APTT testing.
2.4.12.9.Ability to accommodate the use of third party reagents for specialized testing.
2.4.12.10.Hardware Features- The instrumentation shall have the following:
2.4.12.11.A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.
2.4.12.12.An on-board monitor/screen that is easily readable.
2.4.12.13.A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID).
2.4.12.14.An uninterruptible power supply with line conditioner for each instrument provided.
2.4.12.15.Primary tube sampling.
2.4.13.Specific Equipment Requirements-
2.4.13.1.Ability to perform calibration curves on other assays during test run without aborting the run. Multi-lot, Multi-curve reagent management that allows for easy performance of crossover studies to eliminate error and reduce time when new lot numbers are put into use
2.4.13.2.Ability to store, print and retrieve calibration curves where applicable. The instrument must store, print and retrieve curves for factor assays, such that using same lot numbers and patient specimens may be run rapidly and on a STAT basis.
2.4.13.3.Ability for the curve dilutions to be defined by the operator and the curves should be stable for a minimum of three (3) days.
2.4.13.4.D Dimer testing must be FDA approved for exclusion of PE and DVT.
2.4.13.5.Ability to create rerun/reflex rules.
2.4.13.6.Ability to replenish reagents while the analyzer is in operation.
2.4.13.7.Ability to comment on QC points to document troubleshooting and QC review.
2.4.13.8.Analyzer utilizes windows operating software.
2.4.14.Method Performance/Validation Requirements-
2.4.14.1.Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents as required or recommended based on manufacturer’s specifications, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. Acceptable accuracy and precision for PT, APTT, Heparin Xa and Fibrinogen will be <10% CV and D-Dimer will be <5% CV. The method validation will include the following:
2.4.14.1.1.Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.
2.4.14.1.2.Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range when applicable. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.
2.4.14.1.3.Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Where applicable, intra-VISN facility variations should be kept at an absolute minimum.
2.4.14.1.4.Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.
2.4.14.1.5.Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.
2.4.15.Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:
2.4.15.1.A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.
2.4.15.2.If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.
2.4.15.3.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 items must be performed.
2.4.16.Reportable Range Requirements-
2.4.16.1.PT, aPTT, Fibrinogen, D-Dimer, and heparin assays– Contractor shall provide accurate high and low reportable range limits for all clotting assays (i.e., PT, aPTT and fibrinogen), particle agglutination (immunological) assays (i.e., D-dimer) and chromogenic assays (i.e., heparin anti-factor Xa assay and antithrombin activity).
2.4.16.2.Factor Assay Activity – Contractor shall determine a reportable range for all coagulation factors, exhibiting the lowest and highest level of factor activity that can be accurately reported. This determination should be based on a known amount of factor activity plotted against seconds. The reference plasma that is used should be calibrated to a World Health Organization (WHO) standard or a secondary standard. The reportable range determination should be performed for all intrinsic, extrinsic, and common coagulation factors. The reportable range is determined by setting automatic re-dilutions at the highest standard curve point and the lowest standard curve point. The lowest valid point on the curve is used to define the sensitivity of the assay. The lower limit of detection must be <1%. This should apply to all activity assays.
2.4.16.3.Chromogenic Assays – Contractor shall provide or determine a reportable range for chromogenic assays. This study should define the lowest level to the highest level that can be accurately reported. The material used to calibrate the instrument must not be used to determine the reportable range. The sample material used must have a known reference value. A linearity study, if applicable, must be performed to verify the reportable range.
2.4.16.4.For all other tests determined at the site visit (immunologic assay, vWF Ag, PC, PS, etc.), Contractor shall provide or determine a reportable range following the protocols defined for Factor Assay Activity or Chromogenic Assays.
2.4.17.Therapeutic Range Requirements-
2.4.17.1.An ex vivo range must be established. The therapeutic aPTT range must be determined using plasma from patients on unfractionated heparin therapy. Slightly, moderately, and very prolonged aPTT values must be used. Anti-Xa results must be performed to quantify the amount of heparin present relative to the aPTT. A minimum of 50 patient samples must be used. An explanation of this protocol may be found in the current CLSI guideline on one-stage PT and APTT testing.
2.4.17.2.In changing activated partial thromboplastin time (aPTT) methods, preference is given to a reagent system that will provide the same (or nearly the same) heparin responsiveness as the one currently in use.
2.4.18.Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of the facility, reporting the savings realized and shall be shared with personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the CONTRACT. Attachment C may be used as a template to provide these quarterly reports.
2.4.19.Support Features-
2.4.19.1.Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.
2.4.19.2.Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, 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 instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.
2.4.19.3.Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per location per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.
2.4.19.4.Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:
2.4.19.4.1.Service Requirements
2.4.19.4.1.1.A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour.
2.4.19.4.1.2.Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.
2.4.19.4.1.3.Equipment repair response time shall be no more than 24 hours.
2.4.19.4.1.4.Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.
2.4.19.4.1.5.A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:
2.4.19.4.1.5.1.date and time notified
2.4.19.4.1.5.2.date and time of arrival
2.4.19.4.1.5.3.serial number, type and model number of equipment
2.4.19.4.1.5.4.time spent for repair, and
2.4.19.4.1.5.5.proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.
2.4.19.4.2.Each notification for an emergency repair service call shall be treated as a separate and new service call
2.4.19.5.Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the CONTRACT; however, it does refer to significant changes in the hardware operational capability.
2.4.19.6.Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the CONTRACT , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.
2.4.19.7.Interface Requirements
2.4.19.7.1.The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A).
2.4.19.7.2.The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.
2.4.19.7.3.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.
2.4.19.7.4.If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.
2.4.19.7.5.If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.
2.4.19.8.DELETE this line where not required for additional editing
2.4.19.9.Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.
2.4.19.10.Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.
2.4.19.10.1.The determination and description shall address the following:
2.4.19.10.1.1.Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)
2.4.19.10.1.2.Waste ignitability (Reference 40 CFR §261.21)
2.4.19.10.1.3.Waste corrosivity (Reference 40 CFR §261.22)
2.4.19.10.1.4.Waste reactivity (Reference 40 CFR §261.23)
2.4.19.10.1.5.Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)
2.4.19.10.1.6.Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)
2.4.19.10.1.7.Solid Waste (Reference 40 CFR §261.2)
2.4.19.10.1.8.Exclusions (Reference 40 CFR §261.4)
2.4.19.10.2.The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.
2.4.19.10.3.Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 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. 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 Contractor response:
2.4.19.10.3.1.Barium(Total)
2.4.19.10.3.2.Cadmium(Total)
2.4.19.10.3.3.Chromium(Total)
2.4.19.10.3.4.Copper(Total)
2.4.19.10.3.5.Cyanide(Total)
2.4.19.10.3.6.Lead(Total)
2.4.19.10.3.7.Mercury(Total)
2.4.19.10.3.8.Nickel(Total)
2.4.19.10.3.9.Silver(Total)
2.4.19.10.3.10.Zinc(Total)
2.4.19.10.3.11.Arsenic(Total)
2.4.19.10.3.12.Selenium(Total)
2.4.19.10.3.13.Tin(Total)
2.4.19.10.3.14.pH
2.4.19.10.3.15.Flash point(to higher than 200F)
2.4.19.10.3.16.BOD; biochemical oxygen demand
2.4.19.10.4.The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system
2.4.19.11.Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the CONTRACT. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 60 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.
2.4.19.11.1.Upon award of a CONTRACT, the transition period for the awarded CONTRACT to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

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