36C24824Q0567.docx

36C24824Q0567

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.

UEI:

EFT:

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. SIGNAT

URE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24824Q0567 02-09-2024 Leonora Simmons 813-972-7592 03-04-2024 10:00

EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637 X Y 334516 1000 Employees N/A X Department of Veterans Affairs James A. Haley Veterans Hospital (90C) 13000 Bruce B. Downs Blvd Tampa FL 33612 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Tampa FL 33637

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page Contractor shall provide equipment, reagents and test kits in accordance with the SON, RFQ.

Quoters shall read the evaluation criteria prior to submitting a quote.

See CONTINUATION Page x x Leonora Simmons Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

36C24824Q0567

Page 1 of Page 1 of

B.2 STATEMENT OF NEED

Coagulation Instrument, Reagents, Test Kits (CPRR).

1. GENERAL:

1.1. The Contractor shall provide the Name Brand (Instrumentation Laboratory ACL TOPs) or equivalent two (2) Coagulation analyzers to the James A. Haley Veterans Hospital (JAHVH), 10000 Bruce B Downs Blvd, Tampa, FL 33612; one (1) Coagulation analyzer to the New Port Richey VA Outpatient Clinic, 7900 Little Rd, Ste 1PA100, JAH VA New Port Richey, FL 34654; and one (1) Coagulation analyzer to the JAH VA Lakeland Outpatient Clinic, 2080 Meadowland Park Blvd, Lakeland, FL 33803. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein.

1.2. The requirement is for James A. Haley VA Medical Center (JAH VAMC), Pathology & Laboratory Medicine Service, Coagulation Department, Tampa, Florida, and New Port Richey (NPR) VA Laboratory, New Port Richey, Florida and Lakeland VA Laboratory, Lakeland, Florida. This requirement includes any other future JAH VAMC testing location deemed necessary by VA care providers.

2. BACKGROUND:

2.1. The JAHVH Hematology Department of the Pathology & Laboratory Medicine Service has a requirement for an FDA-approved, Name Brand or equal (Instrumentation Laboratory ACL TOPs) automated instrument systems including vendor-provided equipment, reagents, calibrators, controls, supplies, and consumables for coagulation testing for our patient population.

3. PURPOSE:

3.1 The ability to perform Coagulation testing using FDA-approved automated analyzer systems, reagents, calibrators, controls, supplies, and consumables, to provide care for our VA patient population.

4. SCOPE:

4.1. The JAHVH anticipates the award of a Cost per Reportable Result (CPRR) contract to include the use of equipment, reagents, supplies, installation, training, service, and maintenance of the equipment (for the life of the agreement) as identified below.

5. EQUIPMENT:

5.1 The Contractor shall provide four (4) name brand (Instrumentation Laboratory ACL TOPSs) or equivalent Coagulation analyzers that are FDA-approved, fully automated, and integrated analyzer testing systems, printers, computers, uninterruptable power supplies (UPS) for all analyzers, and accessories required for equipment usage.

5.1 Below are the salient characteristics of the FDA-approved, fully automated, and integrated analyzer testing systems, printers, computers, uninterruptable power supplies (UPS) for all analyzers, and accessories required for equipment usage. The proposal shall provide descriptive literature that meets the following specifications for the testing systems and assay requirements:

5.2 General instrument characteristics include the ability to run FDA-approved patient testing for PT, PTT, INR, Fibrinogen, D-dimer, Lupus Panel, Heparin anti-Xa (generic for all types of heparin), HIT, and Ristocetin, Factor Assays, and special coagulation testing to including but not limited to mixing studies.

· Coagulation Analyzers: (Locations: JAHVH, JAH New Port Richey VA Outpatient Clinic, and JAH Lakeland VA Outpatient Clinic).

· General instrument characteristics include continuous operation including continuous sample and reagent loading without interruption of testing in progress.

· Instrument systems include integrated data management system, external printer, and UPS.

· All systems must utilize the same operating system and user interface.

· Instruments must offer extensive test menus capable of performing assays for screening, monitoring, and diagnosis of bleeding and thrombotic risks.

· Instruments must have STAT processing capabilities without disrupting other testing in progress.

· Instrument must include integrated sample and reagent barcode readers capable of reading multiple barcode symbologies.

· Instrument should be capable of performing preanalytical testing to detect tube-fill height issues, flag abnormal sample aspiration due to the presence of clots, as well as detecting interference for hemolysis, lipemia, and bilirubin.

· Data management capability to check QC, calibration, and other quality control options.

· Physical Characteristics include NTE 350 pounds and 60” x 32” x 30”. Must be free-standing or include an instrument cart.

· Electrical Characteristics - 120 V.

NAME BRAND or equal (Instrumentation Laboratory ACL TOPs) OR EQUIVALENT Functionality and Performance Specifications:

· The systems shall be barcode-driven, random access, with continuous loading and unloading of samples, reagents, and consumables.

· The systems shall be flexible, with a minimum throughput of 240 tests per hour for the JAHVH site and 100 tests per hour at other sites.

· The systems shall provide clotting, chromogenic, and turbidimetric testing capabilities to run a complete menu of routine and specialty coagulation assays including, but not limited to, Antithrombin, Protein C & S, Plasminogen, von Willebrand assays, Lupus Anticoagulant assays, Factor V Leiden screening, Heparin Xa, D-Dimer, HIT, and Factor Assays.

· Application Specialists shall be available for implementing and validating new assays, determining Ex Vivi heparin response curves, and providing statistical analysis for reagent lot correlations.

· The systems shall utilize barcoded reagent tracking consisting of material name, lot number, expiration date, and on-board stability and volume.

· Cap piercing capabilities; Safety features to avoid unnecessary exposure to biohazardous and chemical material.

· Reagents and controls shall have extended stability times. A minimum stability of 7 days for PT, APTT reagents, and a minimum stability of 24 hours for routine controls is required.

· The systems shall have repeat and reflex testing capabilities based on user-defined criteria.

· The systems shall have a floor drain-compatible waste system.

· The systems must have a quality control program with configurable multi-rules to evaluate the validity and accuracy of testing.

· The Contractor shall provide peer comparison review and evaluation of quality control statistics.

· The systems shall have auto-programmable QC based on time, number of tests, and reagent changes.

· The systems shall have clot curves to help troubleshoot abnormal, spurious, and unexpected results, identify factor inhibitors, and provide additional clinical information for patient assessments.

· The systems shall only require minimal maintenance with online maintenance and quality control corrective action.

· The systems must be LIS compatible with a bi-directional or host query interface.

· Instrument-Analyzer software must be able to interface with VA-approved middleware software.

· The systems must improve the overall productivity and efficiency of the Coagulation laboratory. The systems should be 100% walkaway and not require monitoring during the testing process.

· Patient Mean Analysis Quality Control program: Required to have a QC program available on instruments or through middleware to monitor shifts and trends of test methods. Prefer company to have the ability to “see” instruments electronically for troubleshooting instrument and quality control problems.

· Comprehensive on-board QC Program, including Troubleshooting or System Validation QC material. The system must have quality control data storage able to store up to 30 separate QC files at the hospital level with a minimum storage capacity of 6 months of QC files, two lot # of calibration for anti-10a, d-dimer and fibrinogen, and reporting capabilities, the ability to view and print daily and monthly QC results, view and print Levy Jennings graphs, visually alert the operator of QC failures and to document out of range QC. Prefer the ability to submit QC data electronically to the company for peer review and to be able to put in electronic comments to document troubleshooting or review of QC data. The routine quality control should be stable on board the analyzer for up to 24 hours with the ability to program the system to auto-execute QC runs.

6. DELIVERABLES:

6.1 JAH VA Hospital (JAHVH) -Two (2) coagulation analyzers to include lease/service/maintenance, qty., 12 MO.

6.2 JAH NPR VA Outpatient Clinic - One (1) Coagulation Analyzer to include lease/service/maintenance.

6.3 JAH Lakeland VA Outpatient Clinic - One (1) Coagulation Analyzer to include lease/service/maintenance.

6.4 Printers, one for each testing site.

6.5 Uninterruptible power supply (UPS), one for each testing site.

7. ESTIMATED TEST VOLUMES, REAGENT KITS AND SUPPLIES

7.1. ESTIMATED ANNUAL CPRR TESTING VOLUMES:

Est. annual billable tests: 84,000

7.2. Estimated Annual CPT Testing Volumes:

7.3 ESTIMATED REAGENTS AND SUPPLIES (One Year Estimated Volumes)

7.4. Inventory Management: The Contractor is required to provide a continuously stocked inventory of reagents, controls, calibrators, troubleshooting controls, and required consumable supplies including all routinely replaced parts, disposables, and any other materials required to properly perform tests on the equipment. All reagents, controls, calibrators, and donor plasma (for annual lot changes) will be of the same lot numbers 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 simultaneously. Lot-to-lot correlation studies are provided for each facility by the contractor. Onboard reagent stability should be sufficient to accommodate both high and low-volume use. PT and APTT reagents should have a bare minimum of 24 hours of on-board stability. Unexpected changes in methodology/technology shall be at the expense of the vendor. Alert/Notification of all technical advisory/recalls/alerts, before or simultaneously with field alerts should be forwarded to lab chiefs or designee. Failure to reserve adequate inventory will result in default.

7.5. Items Included: The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to printers, water supply, consumable equipment parts, required replacement parts for maintenance or service, etc. Any items excluded by the vendor but required for the operation of the system at any time must be delineated in their technical proposal. The cost of any excluded items must be disclosed in the cost proposal.

7.6. Special Handling for Emergency Orders of Supplies: If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival at the government site of the quarterly standing order or routine supply delivery. If the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routing supply delivery or inventory management, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. 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 the operation of the contractor's equipment for one week (under normal government test load volume).

7.7. Quality of Reagents, Supplies, and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be of the highest caliber. The Prothrombin reagent must have an ISI (International Sensitivity Index) approaching 1.0. The variance of the ISI value between reagent lots must not exceed 0.2.* The quality of the reagents must be high enough to satisfy the proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). Interference of heparin in the PT reagent must be minimal. If 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 herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order, if verbal order is received by 1 pm EST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow the operation of the contractor's equipment for one week (under normal government test load volume). The vendor shall reimburse each facility for any costs/supplies related to tests performed by another vendor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

7.6 Returned Goods: The VA is responsible for inspecting all products shipped hereunder and giving the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor. After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. All returns of non-defective products are subject to a restocking charge. No returns will be authorized after 120 days following shipment to VA.

7.7 Shipping Charges: For reagents with hazardous constituents, the Contractor must provide a mechanism for the Laboratory to meet local shipping requirements. No delivery charges for shipping or fee handling. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote and included in CPT.

8. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS:

8.1 Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to the requirements of the system:

a. Support Services 365 days per year. Following a determination that service is required, technical on–site support must be provided under the terms of the Federal Supply Schedule and provide for emergency repairs seven days per week within twenty-four (24) hours of the time of notification of the malfunction. The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government will provide the contractor access to the equipment to perform preventive maintenance service according to the maintenance and service terms below.

· 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.

Business hours service provided for the length of the contract.

· All service, repair, and maintenance (other than user-performed maintenance) will be performed by the contractor with no additional expense to the government. Vendor service must be available within 24 hours of notification by the customer during business hours.

· Contractor retains ownership of instrumentation and will remove instrumentation after the completion of the contract period. Any parts that have been replaced during service will be removed/disposed of by the vendor.

· Vendor to provide hazardous waste determination with proposal. The Hazardous Waste Determination is a procedure used to determine whether the by-products of an analytical process are characterized as a hazardous waste. This information to be provided based on the estimated workload as noted above.

8.2. ADDITIONAL REQUIREMENTS

· SITE PREPARATION: Site preparation specifications shall be furnished in writing by the contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications.

· SPACE REQUIREMENTS, SYSTEM SPECIFICATIONS ETC.: Configuration of the proposed equipment must be able to conform to the space previously allotted for this function. System specifications must all be disclosed in the proposed space. Crossover from current to new instrumentation must be performed timely with no interruption in patient care laboratory service.

8.3. Replacement of Laboratory Equipment: During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the contractor.

9. GOVERNMENT’S RESPONSIBILITY:

9.1. The user will perform daily routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

10. TRAINING OF OPERATING PERSONNEL:

10.1. The Contractor shall provide an instrument training program for all laboratory staff as needed, coordinated with and timely to the equipment installation. This will include training on the operation of the system, data manipulation, and basic troubleshooting and repair. Thereafter, the Contractor will provide training for minimally one operator per facility per year for each model of instrumentation placed. Utilization of the training slots will 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.

11. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE:

11.1. STANDARD AND ACCEPTANCE OF PERFORMANCE: This paragraph establishes a standard of performance that must be met before any equipment listed on the delivery order is accepted by the government. This also includes replacement, substitute instruments, and instruments that are added or field modified after a system has completed a successful performance period.

a. The performance 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 contract at an effectiveness level of 99% or more. 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 the period 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.

b. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will 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.

c. The government will maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

12. REAGENTS DELIVERY TERMS, QUALITY OF REAGENTS, SUPPLIES, AND CONSUMABLES:

12.1. The VA shall require the delivery of reagents, supplies, and consumables for all services required under this contract.

12.2. The contractor shall deliver reagents, supplies, and consumables, shipping cost included, from monthly call orders placed by the JAHVH representative, (COR).

12.3. The contractor shall ensure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce high-quality, accurate patient results.

12.4. The FDA-approved reagent quality must be high enough to satisfy the proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

13. INSTALLATION PROCEDURES:

13.1. Installation of analyzers will be performed by the contractor at no cost to the government. The contractor will provide all parts, labor, supplies, and equipment to install the analyzer. The contractor will complete analyzer function checks during installation to ensure proper operation. The vendor will provide project management to ensure that the overall installation is coordinated with VA and vendor staff to ensure that all aspects of the installation are met to achieve the targeted go-live date.

a. The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility Biomedical engineer. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. If the progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of the delay has been eliminated and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

b. Upon completion of installation the equipment shall be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from the date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government will accept installation with a guaranteed date commencing ten calendar days after installation.

c. Vendor shall provide equipment installation and possible reinstallation at minimal costs if the equipment is required to be moved due to construction or laboratory redesign.

13.2. 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.

13.3 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.

13.4. Method Performance/Validation Requirements. The Contractor shall perform, to the satisfaction of the Government, all validation studies included below. 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. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section below and report data in an organized, clearly comprehensible format. The method validation will include the following:

13.5. Correlation. Correlation studies for each analyte with a minimum of 20 samples (preferably 40) 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.

13.6. Analytical Measurement Range (AMR) Validation. 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.

13.7. Precision. 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.

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

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

13.10. 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.

13.11. Reportable Range Requirements. 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).

13.12. Therapeutic Range Requirements. 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.

14. MAINTENANCE:

14.1. The contractor shall provide maintenance (labor, parts, and shipping) to keep the equipment in good operating condition and subject to security regulations.

14.2. The contractor will ensure that maintenance is scheduled with customer in advance of arrival on site. Vendor will ensure that at least one coagulation instrument is maintained in an operational state always to allow customer to run/report patient workload without delay.

14.3. The government shall provide the contractor access to the equipment to perform maintenance services.

14.4. Preventive maintenance by the contractor shall be provided regular, scheduled maintenance to ensure the continued reliable operation of the equipment. These preventative maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

13. SERVICE:

13.1. Emergency repairs shall be performed within 24 hours after notification that the equipment is inoperative.

13.2. The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Representative (COR). James A Haley VA Hospital, Pathology & Laboratory Medicine Service is open 24 hours a day, 7 days a week including holidays. Lakeland and New Port Richey locations are open Monday through Friday.

13.3. Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification.

13.4. The contractor shall provide all parts, labor, and shipping needed to repair the malfunction.

13.5. The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period.

13.6. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call.

13.7. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

14. TECHINCAL UPGRADES:

14.1. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the vendor shall be performed within 60 days after request.

14.2. Contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

15. WARRANTY OF EQUIPMENT:

15.1. Government requirement for standard manufacturer industry warranty term. The government does not accept an extended warranty, which requires advance payment.

16. DELIVERY SCHEDULE: Delivery performance shall start on 04/01/2024.

17. PLACE OF DELIVERY:

17.1. Tampa Main Hospital - Department of Veterans Affairs, James A. Haley Veterans Hospital, 13000 Bruce B. Downs, Blvd. Tampa, FL. 33612. New Port Richey Clinic – Department of Veterans Affairs, 7900 Little Rd, New Port Richey, FL. 34654. Lakeland Clinic - James A. Haley VA Lakeland Outpatient Clinic, 2080 Meadowland Park Blvd, Lakeland, FL. 33803.

With Sensitive Data and Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

c. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

d. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

1. Position Sensitivity – The position sensitivity has been designated as (low) risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

3. Contractor Responsibilities:

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.

The website that provides information on the cost of the security investigation is:

www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain U.S. citizenship and can read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) a List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM, and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

e. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

VA INFORMATION CUSTODIAL LANGUAGE:

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in the performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that the VA’s information is returned to the VA or destroyed in accordance with the VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, the contractor/subcontractor must not destroy information received from VA or gathered/created by the contractor in the course of performing this contract 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 of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose, and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations, and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.1, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for the performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, the confidentiality of medical quality assurance records, and/or Title 38 U.S.C. 7332, the confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) every year and provide it to the COR.

SECURITY INCIDENT INVESTIGATION:

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss, or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the…