36C26321Q0102.pdf

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Attached to: 6550--5 year single award Indefinite Quantity-Indefinite Delivery contract for CPRR Clinical Laboratory Coagulation Instrumentation
Solicitation number: 36C26321Q0102
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 23

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File	Type	Posted
36C26321Q0102 A0001.pdf	PDF	Dec 17, 2020
Attachments A - C - Template for Vendors UPDATED.xlsx	XLSX spreadsheet	Dec 17, 2020
QA.pdf	PDF	Dec 17, 2020
36C26321Q0102 A0001_1.docx	DOCX document	Dec 17, 2020
Attachment E MFG_Waste_Evaluation_Form.docx	DOCX document	Dec 2, 2020
Attachments A - C - Template for Vendors.xlsx	XLSX spreadsheet	Dec 2, 2020
36C26321Q0102_1.docx	DOCX document	Dec 2, 2020

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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 71

36C263-20-AP-4516

36C26321Q0102 12/02/2020

JOSH IMDACHA 3193397017 1/06/2021

4PM CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

334516

1000 Employees

N/A

VISN 23 VA HEALTH CARE SYSTEM

MULTIPLE SEE STATEMENT OF WORK

FOR DETAILS

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The Department of Veterans Affairs VISN 23, VA Health Care System is soliciting for a 5 year single award

Indefinite Quantity-Indefinite Delivery contract vehicle for CPRR Clinical Laboratory Coagulation Instrumentation

Please note this is a 5-year contract. You will need to submit 5 years’ worth of pricing at the time of submission.

ALL QUESTIONS NEED TO BE SUBMITTED 72 HOURS BEFORE RFQ

CLOSE TO BE CONSIDERED. EMAIL ALL QUESTIONS TO

JOSHUA.IMDACHA@VA.GOV & RICHARD.LEISTIKO@VA.GOV

SIGN SF1449 AND RETURN ALL PAGES WITH OFFER SUBMISSION

This will result in a single award IDIQ with 5 one year ordering periods.

See CONTINUATION Page

N/A

X X

X 1

36C26321Q0102

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK – Clinical Laboratory Coagulation Instrumentation

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 GOVERNING LAW

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.7 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020) ..43

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (OCT 2020)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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 36C263

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon Delivery and Acceptance

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 STATEMENT OF WORK – Clinical Laboratory Coagulation Instrumentation

1. IDIQ LANGUAGE

1.1. INTENT: It is the intent of the Department of Veterans Affairs VISN 23 Pathology and Laboratory

Medicine Service Line (P&LMS), (herein afterwards referred to as VISN 23) to establish an

Indefinite Delivery Indefinite Quantity for Automated Coagulation Instrumentation. The

Government will award a CPRR IDIQ to a single Contractor for Automated Coagulation

Instrumentation. Contractor agrees to the following terms of the IDIQ exclusively with the VISN facilities listed by Attachment/herein and awarded in the final IDIQ. However, as requirements change, facilities within VISN 23 may be added or deleted by supplemental agreement of the

Government and the Contractor. Additional tests/reagents/instrumentation may be added to the

IDIQ as new technology becomes available on the market.

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SCOPE OF PROCUREMENT:

1.1.1. 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).

1.1.2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

1.1.3. If Contractor offers a family of analyzers, VISN 23 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.4. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

1.1.5. 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.

1.1.6. 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.

1.2. DEFINITIONS:

1.2.1. 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.

1.2.2. Parameter definitions-

1.2.2.1. PT- Prothrombin Time

1.2.2.2. APTT-Activated Partial Thromboplastin Time

1.2.2.3. INR- International Normalized Ratio

1.2.2.4. ISI- International Sensitivity Index

1.3. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes.

1.4. GENERAL REQUIREMENTS:

1.4.1. 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.

1.4.2. Contractor shall provide quality control material at a minimum of two levels necessary for testing described in Attachment A; this shall be normal and elevated/abnormal levels for each analyte being tested. Minneapolis operates both analyzers simultaneously. All other sites with multiple analyzers operate one instrument at a time.

1.4.3. All reagents, controls, calibrators, and normal donor plasma (for annual lot changes) will be of the same lot number for each integrated healthcare systems. Lot numbers will be in use at least twelve (12) months. Sites within an integrated healthcare system covered under this IDIQ will convert to the new yearly lot number within 2 months of each other if they are operating on the same reagents. Integrated systems are sites located within

Nebraska-Western Iowa Healthcare System (Omaha, Lincoln, and Grand Island); and sites located within Black Hills Healthcare System (Ft. Meade and Hot Springs).

1.4.4. Assayed control plasma for PT and APTT are required.

1.4.5. The product information must specify an appropriate ISI for the instrument and reagent lot number combination.

1.4.6. The ISI value for PT reagents must be less than 1.3. The variance of the ISI value between reagent lots ideally should not exceed 0.2.

1.4.7. Documentation must be provided regarding the effect of lupus anticoagulants in the therapeutic monitoring of warfarin.

1.4.8. Interference of heparin in the PT reagent must be minimal.

1.4.9. Operational Features- The instrumentation offered shall have the following:

1.4.9.1. The capability of performing analysis on 100% of the tests listed in Attachment A.

1.4.9.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

1.4.9.3. 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.

1.4.9.4. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system and Data Innovations (DI) middleware. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

1.4.9.4.1. The accuracy of the barcode reading must have less than a 1% failure rate.

1.4.9.4.2. Equipment must be able to support multiple barcode formats (Code 39, Code

128) that may be enabled concurrently.

1.4.9.4.3. Equipment must accept, at a minimum, a 10 character specimen identifier that is alphanumeric.

1.4.9.5. Ability to prioritize STAT testing without compromising existing programmed testing.

1.4.9.6. Minimal daily, monthly, and periodic maintenance.

1.4.9.7. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

1.4.9.8. Capability to store a minimum of 4000 patient records in a database for immediate recall.

1.4.9.9. Ability to accept various types of sample containers.

1.4.9.10. Minimize interference in lipemic, hemolyzed, or icteric samples and label/flag the specimen as having an interference.

1.4.9.11. An on-board refrigeration system for reagents.

1.4.9.12. Minimum twenty-four (24) hour on-board stability of PT and APTT reagents.

1.4.9.13. Minimum eight (8) hour stability of quality control (QC) material; longer stability preferable.

1.4.9.14. Capability to detect out of range quality control.

1.4.9.15. Ability to automatically program the performance of QC testing preferred.

1.4.9.16. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 12 months for reagent sequester.

1.4.10. Technical Features- The instrumentation must be approved by the Food and Drug

Administration (FDA) and shall have the following:

1.4.10.1. On-board QC data management system that includes Levy-Jennings graphs.

Analyzer must have the ability to capture and store QC data. Electronically transfer of

QC data is highly desirable.

1.4.10.2. Ability to monitor instrument performance.

1.4.10.3. On board reagent inventory system.

1.4.10.4. Minimal carryover.

1.4.10.5. Long calibration stability.

1.4.10.6. Minimal reagent, calibrator, and control preparation.

1.4.10.7. No specimen pre-treatment required for PT and APTT testing.

1.4.10.8. Ability to accommodate the use of third party reagents for specialized testing highly preferred.

1.4.11. Hardware Features- The instrumentation shall have the following:

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

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

1.4.11.3. 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).

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

1.4.11.5. Primary tube sampling.

1.4.12. Specific Equipment Requirements-

1.4.12.1. Ability to perform calibration curves on other assays during test run without aborting the run.

1.4.12.2. 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.

1.4.12.3. Ability for the curve dilutions to be defined by the operator and the curves should be stable for a minimum of three (3) days.

1.4.12.4. D Dimer testing FDA approved for exclusion of PE and DVT highly preferred.

1.4.12.5. Ability to accept closed tube samples.

1.4.12.6. Ability to create rerun/reflex rules.

1.4.12.7. Ability to replenish reagents while the analyzer is in operation.

1.4.12.8. Ability to comment on QC points to document troubleshooting and QC review highly preferred.

1.4.12.9. Ability to transmit QC to company via direct link for peer review highly preferred.

Additional MOUs must be in place with OI&T.

1.4.12.10. Analyzer Windows Operating Software highly preferred.

1.4.13. Method Performance/Validation Requirements-

1.4.13.1. 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. Precision should be the best CV available but no greater than 10% for PT, APTT, Heparin Xa and Fibrinogen and no greater than 5% for D-Dimer. Bias should be minimal. The method validation will include the following:

1.4.13.1.1. 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.

1.4.13.1.2. Analytical Measurement Range (AMR) Verification shall be performed on proposed instrument(s) for each analyte to validate the reportable range when applicable. The material must have values, which, at a minimum, include the low, mid, and high range of the AMR and be of appropriate matrix for the clinical specimens assayed by that method.

1.4.13.1.3. 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.

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

1.4.13.1.5. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

1.4.14. 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:

1.4.14.1. 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.

1.4.14.2. 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.

1.4.14.3. 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.

1.4.15. Reportable Range Requirements

1.4.15.1. 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).

1.4.15.2. 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.

1.4.15.3. 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.

1.4.15.4. 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.

1.4.16. ☒ (Applies only if selected) Therapeutic Range Requirements-

1.4.16.1. An ex vivo range must be established as required by site based on testing platform. 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. An explanation of this protocol may be found in the current CLSI guideline on one-stage PT and APTT testing.

1.4.17. 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 each facility, reporting the savings realized and shall be shared with each participating facility, 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 shall not be accepted.

There will be no additional charges for any reports required as part of the IDIQ.

Attachment C may be used as a template to provide these quarterly reports.

1.4.18. Support Features-

1.4.18.1. 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.

1.4.18.2. 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.

1.4.18.3. 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 facility per year per analyzer 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.

1.4.18.4. 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:

1.4.18.4.1. Service Requirements

1.4.18.4.1.1. 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 2 hours.

1.4.18.4.1.2. Equipment repair service shall be provided during core business hours.

Core business hours are considered Monday – Friday 0800-1700. 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.

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

1.4.18.4.1.4. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

1.4.18.4.1.5. 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:

1.4.18.4.1.5.1. date and time notified

1.4.18.4.1.5.2. date and time of arrival

1.4.18.4.1.5.3. serial number, type and model number of equipment

1.4.18.4.1.5.4. time spent for repair, and

1.4.18.4.1.5.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

1.4.18.4.2. Each notification for an emergency repair service call shall be treated as a separate and new service call.

1.4.18.5. 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 IDIQ; however, it does refer to significant changes in the hardware operational capability.

1.4.18.6. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the IDIQ , 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.

1.4.18.7. Interface Requirements

1.4.18.7.1. 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).

1.4.18.7.2. 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.

1.4.18.7.3. 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.

1.4.18.7.4. 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.

1.4.18.7.5. 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.

1.4.18.8. 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.

1.4.18.9. 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) or hyperlink meeting the requirements of the

Occupational Safety and Health Administration (OSHA) and Environmental Protection

Agency (EPA); Chemical Evaluation Form (Attachment E) or similar format; and 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.

1.4.18.9.1. The determination and description shall address the following:

1.4.18.9.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

1.4.18.9.1.2. Waste ignitability (Reference 40 CFR §261.21)

1.4.18.9.1.3. Waste corrosivity (Reference 40 CFR §261.22)

1.4.18.9.1.4. Waste reactivity (Reference 40 CFR §261.23)

1.4.18.9.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR

§261.31)

1.4.18.9.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

1.4.18.9.1.7. Solid Waste (Reference 40 CFR §261.2)

1.4.18.9.1.8. Exclusions (Reference 40 CFR §261.4)

1.4.18.9.2. 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.

1.4.18.9.3. 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:

1.4.18.9.3.1. Barium (Total)

1.4.18.9.3.2. Cadmium (Total)

1.4.18.9.3.3. Chromium (Total)

1.4.18.9.3.4. Copper (Total)

1.4.18.9.3.5. Cyanide (Total)

1.4.18.9.3.6. Lead (Total)

1.4.18.9.3.7. Mercury (Total)

1.4.18.9.3.8. Nickel (Total)

1.4.18.9.3.9. Silver (Total)

1.4.18.9.3.10. Zinc (Total)

1.4.18.9.3.11. Arsenic (Total)

1.4.18.9.3.12. Selenium (Total)

1.4.18.9.3.13. Tin (Total)

1.4.18.9.3.14. pH

1.4.18.9.3.15. Flash point (to higher than 200F)

1.4.18.9.3.16. BOD; biochemical oxygen demand

1.4.18.9.4. 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.

1.4.18.10. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the IDIQ. 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 90 day timeframe, if the extension is through no fault of the

Contractor and is a result of delays due to the Government.

1.4.18.10.1. Upon award of a IDIQ, the transition period for the awarded IDIQ to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

1.4.18.10.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded IDIQ including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the

Contractor to conform to the transition period shall be considered as sufficient cause to terminate IDIQ for cause under the Termination for Cause clause of the

IDIQ.

1.4.18.10.3. At the end of 90 days from award of the IDIQ, the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ.

1.4.19. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or IDIQ] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any IDIQ at an effectiveness level of 90% or more.

1.4.19.1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of

30 consecutive days.

1.4.19.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled

“Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

1.4.19.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the

Government in proper operating condition.

1.4.19.4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

1.4.19.5. The Government will maintain daily records to satisfy the requirements of the

Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

1.4.19.6. During the term of the IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the

Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

1.4.20. Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

1.4.21. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The

Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

1.4.22. The Contractor will identify if removable media is required to perform their duties. The

Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

1.4.23. Prior to termination or completion of this IDIQ, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this IDIQ without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with

National Archives and Records Administration (NARA) requirements as outlined in VA

Directive 6300, Records and Information Management and its Handbook 6300.1 Records

Management Procedures, applicable VA Records Control Schedules, and VA Handbook

6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the IDIQ.

1.4.24. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA

Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the

IDIQ or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the

Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the

IDIQ or disposal or return of the IT equipment, whichever is earlier.

1.4.25. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

1.4.25.1. Contractor must accept the system without the drive;

1.4.25.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

1.4.25.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

1.4.26. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1.4.26.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

1.4.26.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or IDIQ.

1.4.26.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

B.3 PRICE/COST SCHEDULE

The Department of Veterans Affairs has set the ceiling limitation for this IDIQ at $1,300,000.00 for the lifetime of this contract. The total of all orders placed against this IDIQ will not exceed this ceiling.

The minimum guaranteed total is set at $75,000 for the lifetime of this contract.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QTY UNIT UNIT PRICE AMOUNT

114,800 ea __________________ __________________

Contract Period: Base POP Begin:

POP End:

26,060 ea __________________ __________________

PTT

Contract Period: Base

8,350 ea __________________ __________________ D-Dimer

Contract Period: Base

2,660 ea __________________ __________________ Fibrinogen

Contract Period: Base

250 ea __________________ __________________ Lupus Inhibitor

Contract Period: Base

70 ea __________________ __________________ Protein C

Contract Period: Base

Protein S

Contract Period: Base

Antithrombin III

Contract Period: Base

15 ea __________________ __________________ Factor II

Contract Period: Base

20 ea __________________ __________________ Factor V

Contract Period: Base

Factor VII

Contract Period: Base

40 ea __________________ __________________ Factor VIII

Contract Period: Base

Factor IX

Contract Period: Base

Factor X

Contract Period: Base

Factor XI

Contract Period: Base

Factor XII

Contract Period: Base

245 ea __________________ __________________

LMWH

Contract Period: Base

2,215 ea __________________ __________________

UFH

Contract Period: Base

Contract Period: Ordering Period 1

Contract Period: Ordering Period 2

Contract Period: Ordering Period 3

Contract Period: Ordering Period 4

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

C.1 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Contract.

Commercial license agreements may be made a part of this Contract only if both parties expressly make them an addendum hereto.

Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. SS 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. SS 1341 et seq), the Competition in Contracting Act (41 U.S.C. SS 3301 et seq), the Prompt Payment Act (31 U.S.C SS 3901 et seq).

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File details come from the government source that posted it. Updated Dec 2, 2020.