36C24725P0048_1.pdf

Justification and Approval Notice

*= Required Field Justification and Approval Notice

SUBJEC

T*

VISN Fecal Occult Blood Analyzers and Testing - Base

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 30901

SOLICITATION NUMBER*

DELIVERY/TASK ORDER NUMBER 36C24725P0048

BASE NOTICE TYPE

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* 6550

NAICS CODE* 334516

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

VISN 7 Network Contracting Activity

LaVista Business Park-Building A

2008 Weems Road

Augusta GA 30901

POINT OF CONTACT* Contract Officer

Leonard Robinson leonard.robinson@va.gov

AWARD INFORMATION

STATUTORY AUTHORITY* FAR 13.5 - Simplified Procedures for One Source

AWARD NUMBER* 36C24725P0048

MODIFICATION NUMBER

AWARD AMOUNT* $537,268.72

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)* 10-01-2024

AWARDEE NAME*

CONTRACTOR’S UEI

POLYMEDCO LLC

STNDUK44ENE8

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 3* 510 FURNACE DOCK RD

AWARDEE ADDRESS LINE 4*

AWARDEE CITY CORTLANDT MANOR

AWARDEE STATE NY

AWARDEE ZIP CODE 10567

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov

URL DESCRIPTION Department of Veterans Affairs

AGENCY CONTACT’S EMAIL ADDRESS leonard.robinson@va.gov

EMAIL DESCRIPTION RPO-East, NCO 07

DESCRIPTION

STATEMENT OF WORK

VISN 7 Fecal Occult Blood Immunoassay

SCOPE:

VISN 7 Medical Centers requires automated fecal occult blood analyzer(s) to perform testing on the Veteran patient population. The contractor shall provide the analyzer, service and all supplies to each Medical Center per the estimates given in the Statement of Work. The contractor shall perform to the standards in this contract. This contract shall not require access to a VA system or VA sensitive information (e.g., system administrator privileged access to a VA system, or contractor systems or processes that utilize VA sensitive information). The Contractor in accordance with the terms and conditions stated herein will propose and furnish analyzers as volume dictates to the following VISN 7 Medical Centers.

Facility Name Address/ Analyzer

Atlanta VAMC 1670 Clairmont Rd.

Decatur, GA 30033

X

Birmingham VAMC 101 25th Street South Birmingham, AL 35233

X

Ralph H. Johnson

VAMC

3101 Pacific Street North Charleston, SC 29418

X

Columbia VA Health Care System

6439 Garners Ferry Road Columbia, SC 29223

X

215 Perry hill Road Montgomery, AL 36109

X

2400 Hospital Road Tuskegee, AL 36083

Central Alabama Veterans Healthcare System (CAVHCS)

Tuscaloosa VAMC 3701 Loop Road Tuscaloosa, AL 354

Dublin VAMC 1826 Veterans Blvd.

Dublin, GA 31021

Testing to be done by

CAVHCS

Contractor shall provide the supplies at the prices specified in Schedule of Services and Prices of this contract. The initial listing of supplies to be furnished is identified in the Schedule of Services and Prices, and Statement of Work.

PERIOD OF PERFORMANCE

This contract is effective for one (1) base year upon contract award and includes four (4) one-year options to extend the term of the contract. The Contracting Officer in conjunction with the COR will unilaterally exercise each option year period with prior notice to the Contractor.

The Contractor shall be required to begin providing on-site training, equipment, reagents, standards, supplies, consumables/disposable items, parts, accessories, and any other item required for the proper operation of its’ contractor owned Automated iFOBT Analyzer and peripherals necessary for the generation of immunological fecal occult blood analysis Cost Per Reportable Result (CPRR) services as required on effective date of contract award.

STATEMENT OF WORK/SERVICES TO BE PROVIDED:

1. GENERAL REQUIREMENTS:

1.1. The vendor(s) shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to the participating VISN 7 VAMC facilities in accordance with the applicable Federal Supply Schedule contract.

1.2. Assessment of test volumes and testing needs shall be automatically extended to any and all existing and new VISN 7 facilities (CBOC, MOCs, etc. acquired during the contract period) should they request to participate in this agreement.

1.3. The pricing shall be based on new state of the art equipment. Remanufactured or used models will not be accepted. The vendors’ offered Fecal Occult Blood Immunochemical analyzer shall conform to the facilities/clinics existing space.

1.4. The analyzer/equipment shall meet the test volume in Attachment 1 (Test Volumes) and match or improve the turnaround time requirements. The system shall streamline all aspects of testing, thereby enhancing operational efficiency, supporting improved patient outcomes, and improving the productivity of the using facilities/clinics.

1.5. Vendors shall provide each participating facility with Food and Drug Administration (FDA) cleared analyzer/equipment, reagents, controls, calibrators/standards, mailing system for mailing/transport, disposables, and any consumable part necessary for analyzing/testing. Vendor shall list the consumable parts provided. Vendor shall state any parameter/function that is pending FDA approval at the time of this BPA submission.

2. SYSTEM REQUIREMENTS:

2.1. Offered models of Automated Fecal Occult Blood Analyzers shall be capable of producing accurate and reproducible results on fecal specimens by established in vitro immunochemical diagnostic methods. Models shall provide accurate test assay results for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

2.2. Model must be capable of specifically detecting human hemoglobin, thereby removing the need for dietary restrictions and the collection and testing of more than one sample.

2.3. Model must include a specimen transport system that is stable for a minimum of 14 days at ambient temperature for those specimens collected in the home setting, at community based outpatient clinics and remote sites requiring an extended transport time.

2.4. Vendor to provide mailing system for specimen transport that meets the US Postal Service mailing requirements. Mailing system must be easy to use and include, but not limited to, specimen collection and labeling instructions, specimen transport tube/vial/card, and mailing envelop. Vendor shall work with each facility to develop an acceptable system to meet the needs for postage and addressing mailing envelops of that facility.

2.5. Vendor to provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements.

2.6. Analyzer shall have the capability of providing printouts for all patient results, calibrators, and controls.

2.7. All consumable supplies (reagents, standards, controls, disposable, etc…) required for the proper operation of the contractor’s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the contractor for each Fecal Occult Blood Immunoassay analyzer.

2.8. The contractor shall maintain at each facility a continuously stocked inventory of shipping supplies/containers, reagents, standards, controls, supplies, disposables and any other material required to properly perform tests on the offered equipment.

These items shall be of the highest quality ensuring sensitivity, specificity, and have been previously tested to assure their precision and accuracy. The quality of the products shall be within the acceptable proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

2.9. The system shall have a design that supports the result integrity/removes the possibility of sample carryover.

2.10. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 45 and 80 percent and any laboratory temperature between 50 and 90 degrees Fahrenheit (10 to 32 degrees Celsius).

3. INSTRUMENTATION AND SOFTWARE:

3.1. The vendor is to conduct and complete the Medical Equipment Pre-procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI&T) for each facility for any medical device that will be connected to the VA information network. The vendor then shall provide evidence of VACO approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place (see attached Addendum). If there will be web communication between VA facilities, the data/transmission must be encrypted per FIPS 140-2 standards.

3.2. The equipment must include 120 volt UPS that has a 10 minute back-up capability.

3.3. The system must support multiple barcode formats including but not limited to Code 39, Code 128, and Codabar or current VA standardized barcode that may be enabled concurrently.

3.4. The system shall have a barcode reader for sample identification and download from host. The barcode reader must be able to read current standardized VA barcode formats.

3.5. The vendor shall provide the following interfacing requirements for the analyzer:

a. Instrument LIS physical connection and LIOS Host Specifications

b. Routing must be fully supported by all laboratory instrument interface partners, especially Data Innovations, Inc. and Cerner

c. Technical assistance with only interfacing the analyzer

d. Instrument-LIS interface must be uni-directional

e. Provide documentation of successful interfacing with other VA facilities (provide two VAMC references to include contact person, address and telephone number)

f. Interface must use automatic transferal/transmission of sample IDs and control test results to the host computer.

g. In lieu of an LIS interface, the vendor may provide a TCP/IP interface preapproved/certified by VACO for use with VA computer systems and applications such as VistA. Proof of certification must be provided. The vendor will provide all necessary information (including logical ports) for VA staff to write an access control list

3.6. The system shall be able to store and retransmit records (24 hours of maximum instrument throughput) in case of interface downtime. The vendor is to state how many samples can be stored. The system shall have the ability to allow for manual entry of sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification.

3.7. The vendor shall provide all upgrades to the equipment software and operating systems without additional charge to the Government. These enhancements to the vendor’s equipment shall be delivered and installed at the site within six (6) months of their issuance or date of first commercial availability. The vendor will at all times maintain compatibility of systems with whatever host LIS or TCP/IP interface is in place, especially when vendor software is upgraded.

3.8. Requests for additional instrumentation, upgrades, or replacement will be evaluated by the facility laboratory with communication to the vendor.

3.9. Footprint of system should be small and fit on a typical laboratory countertop (i.e., less than 24” deep x 24” wide x 17” high). Contractor shall provide measurements for proposed analyzers.

3.10. System should offer a data management system that allows the user to monitor and analyze test data and quality control. System includes flags for unusual results and failed quality control.

3.11. System must include electronic operating manuals and troubleshooting guide as well as a daily and weekly maintenance guide and log.

3.12. A post award conference shall be held to discuss the guidelines for implementation.

3.13. The contractor shall remove all equipment within 90 days after notification of the expiration of the terms of this BPA but not until the completion of new vendor’s equipment installation inclusive of completed cross over studies. Each facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If a VA facility chooses to retain the hard drive, it will be at no additional cost to the VA.

3.14. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National

Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s Web site at:

http://checklists.nist.gov .

4. INSTALLATION AND VALIDATION:

4.1. All new equipment shall be shipped within 60 calendar days of receipt of an award of the contract. All new instruments shall be installed and operational within 30 calendar days of delivery. Reagents and supplies shall be shipped within 10 calendar days after receipt of an order except for rare emergency orders which require overnight shipment. The contractor shall make arrangements with the facility for installation of equipment and training of key equipment operators. All current SDS shall be provided with the offer. Additionally, SDS shall be provided to each affected site whenever a new or revised reagent is supplied during the contract period. These SDS shall be received by each affected site prior to or simultaneously with the shipment of goods, along with documentation highlighting any changes.

4.2. The contractor shall guarantee to delivery equipment within 60 calendar days after receipt of a purchase order. Order for reagents, QC products, consumable supplies, etc. shall be delivered within 10 calendar days after receipt of an order. The contractor shall complete installation and onsite validation within 30 days of order of delivery.

4.3. The vendor will provide technical support specialist(s) to assist in equipment installation/set-up, correlation studies (evaluation/comparison of data sufficient to satisfy CAP standards, CLSI and related documents, and Federal Regulations), staff training, methodology problems, and questions. Method Performance/Comparison shall include but is not limited to:

a. Accuracy studies for each analyte: A minimum of 20 samples, consisting of an adequate number of both positive and negative samples will be run by the present and the proposed method. Contractor will assist with analyzing results and provide data to support acceptance of the new method. The evaluation will include validation of accuracy, in concordance to current method and meet current standards defined by CLSI.

b. Precision study using negative and positive control material: This will consist of a within run precision study of 10 negative and 10 positive controls. Inter-VISN facility variations should be kept at an absolute minimum.

c. Specificity Studies: Manufacturer’s package insert, including any limitations and/or interferences, will be provided by the contractor.

d. Sensitivity Studies: Manufacturer’s package insert will be provided by the contractor.

e. Carryover Studies: Presence of assay carryover is ruled out during the contractor’s instrument validation process. Documentation of carryover studies performed during the validation process will be provided by the vendor.

4.4. The vendor shall provide each participating facility/clinic with all reagents, calibrators, controls, and any cross-over supplies needed at installation and during training of staff. The vendor shall pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff. Test counts for billing will begin after all CAP required studies, performed at installation of new equipment, are reviewed, approved, and the analyzer has been placed in use for patient testing.

4.5. At installation/set-up the vendor/technical support specialist shall perform and place in a labeled binder all validation studies including: installation/set-up, correlation studies, and cross-over studies. Evaluation/comparison data shall be sufficient to satisfy CAP standards and shall be completed within two weeks of installation at each facility/clinic. The support specialist shall assist with staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. The technical support specialist must be available for installation/set-up/validation studies/training for a minimum of 16 hours during regular office hours on a 5 days/week basis.

4.6. The vendor shall provide assistance with equipment de-installation and possible reinstallation if the equipment is required to be moved due to construction or laboratory redesign. The vendor shall not be responsible for cost associated with equipment removal or relocation due to construction or Laboratory redesign.

4.7. The vendor shall specify their routine shipment table of supplies, whether monthly or quarterly, and how much storage space would be needed for each. The vendor shall ensure that all reagents/supplies received, whether it is monthly or quarterly standing order, have at least a six month expiration date. The vendor shall work with each facility/clinic to adjust reagent supply to match workload changes and to provide the option annually for each facility/clinic to adjust the shipment table. The vendor shall state what their policy is in regards to adjusting a standing order or ordering an additional shipment of supplies.

5. SUPPORT SYSTEMS (SERVICE, PREVENTATIVE MAINTENANCE AND SHIPPING OF

SUPPLIES)

5.1. Vendor will provide technical support services Monday-Friday, 8am-5pm at no additional charge to all participating VISN 7 facilities. Technical support by telephone shall be available 7 days a week, 24 hours a day. Technical support shall return all downtime calls within one hour. Should on-site service be required, the contractor’s field service organization shall provide on-site service response within 24 hours from time of dispatch. All replacement instrument/equipment must be received within 24 hours from the time the on-site service arrives. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed.

5.2. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within two hours of trouble-shooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facilities staffing.

5.3. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs.

5.4. Requests for services will be through one contractor.

5.5. The vendor shall provide instrument support service sufficient to provide assistance with troubleshooting and repair of the analyzer. The vendor may list their service options available. At an additional cost, the following service options may be available: 24 hours/day, 7 days/week basis for hospitals. The support service shall follow-up all down calls within 1 hour. At all times, the contractor shall keep the facility informed of the time line for when repairs are to be completed. All repairs on instruments shall be complete (at no cost to the facility) within 24 hours from the time the field service engineer arrives.

5.6. In the event that the consumables are found to be defective and unsuitable for use with the vendor's equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting VISN 7 facility site, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume).

If additional requests for emergency supply delivery are required by the Government, they will be honored by the vendor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory will result in default.

5.7. Frequency of shipments. Vendor will provide initial inventory based on expected use, then establish a standing weekly/monthly/quarterly shipment based on current use, with the capacity to fill emergency requests on demand.

5.8. Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing and will pay for shipping for volume adjustments should additional supplies be required.

5.9. The vendor must provide consumable replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results.

5.10. The vendor’s technical service representatives must comply with each facility’s requirements for onsite vendor representatives.

6. TRAINING AND PROCEDURES:

6.1. Vendor must provide all education/training on site during installations or update to the equipment. Training is to include staff on all shifts. Training must include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site.

6.2. Provide initial in-depth training for two key operators at each site and upon request annual training for one VA equipment operator, per participating VISN 7 Medical Center. Key operator training is to include all costs of vendor off-site training, i.e., transportation (air and ground), and room and board.

6.3. The vendor shall provide on-site refresher instrument training in renewal option years of the contract if so exercised.

6.4. Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and MSDSs (also available in electronic format). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Vendor must provide assistance in creating daily and weekly maintenance and quality control records or logs to meet the needs of the facility.

7. PAYMENTS AND INVOICING:

All invoices will be paid monthly in arrears upon receipt of invoice. Each invoice shall indicate the month in which the items were delivered and the appropriate obligation number. VA will review the invoices and match them against VA bill validation report to verify that services were performed in accordance with solicitation. VA will notify the contractor of invoice discrepancies. Upon the resolution of the discrepancies, contractor shall submit a revised invoice; VA will verify revised invoice and make payment accordingly.