Attachment A.docx

Attachment A RFQ 36C24525Q0045 The Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking vendors that can provide HPV Testing for the Washington DC VA Medical Center.

ITEM INFORMATION

APTIMA HPV TEST KIT

Contract Period: Base POP Begin: 12-01-2024 POP End: 11-30-2025

LOCAL STOCK NUMBER: 303236

Aptima HPV 16 18/45

POP Begin: 12-01-2024

LOCAL STOCK NUMBER: 303570

KIT, PATIMA LPT-IVD

POP Begin: 12-01-2024

LOCAL STOCK NUMBER: 301154c

Waste Bin Cover

POP Begin: 12-01-2024

LOCAL STOCK NUMBER: 902714

HPV HOLISTIC TESTING COST PER TEST

Contract Period: Option 1 POP Begin: 12-01-2025 POP End: 11-30-2026

HPV HOLISTIC TESTING COST PER TEST

Contract Period: Option 2 POP Begin: 12-01-2026 POP End: 11-30-2027

HPV HOLISTIC TESTING COST PER TEST

Contract Period: Option 3 POP Begin: 12-01-2027 POP End: 11-30-2028

HPV HOLISTIC TESTING COST PER TEST

Contract Period: Option 4 POP Begin: 12-01-2028 POP End: 11-30-2029

Manufacturer: Hologic

STATEMENT OF WORK

MICROBIOLOGY MOLECULAR EQUIPMENT AND REAGENTS

Cost Per Test

1. GENERAL:

The Contractor shall provide to the laboratory reagents, maintenance and preventive services and a quality control program for the molecular analyzer containers on a cost per test basis to the Department of Veterans Affairs Medical Center in Washington DC (VAMCDC), 50 Irving St. NW Washington DC 20422.

2. PERIOD OF PERFORMANCE:

3. PLACE OF PERFORMANCE:

Pathology & Laboratory Medicine, Microbiology Section (GB-105), 50 Irving St. NW Washington DC 20422.

4. DAYS AND HOURS OF OPERATION:

Monday - Friday, 7:00am-11:00pm, Saturday, Sunday and including federal holidays 7:00am-3:30pm.

5. EQUIPMENT DESCRIPTION:

I. Supplies - The vendor must provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the contract and required to maintain the instrument operations capability with the ThinPrep collection containers system that we are currently utilizing in our facility. The vendor will 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 vendor will perform all of the statistical analysis and report data in an organized, clearly comprehensible format.

II. Training - The vendor must 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. This will include training on the operation of the system, data manipulation, and basic trouble shooting and repair. The vendor will provide training for two operators for each model of instrumentation placed. Utilization of the training slots will be mutually agreed upon between the Washington DC facility laboratory and the vendor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

III. Equipment Preventative Maintenance/Repair Service - The vendor must be able to provide emergency equipment repair and preventative maintenance on all instruments and any incremental support equipment, e.g. water system, offered according to the following terms:

a. A technical assistance center must be available by telephone 7am to 10pm EST with a maximum call back response time of 2 hours.

b. Equipment repair service must be provided during routine business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the contractor and VA laboratory personnel.

c. Equipment response time will be no more than 12 hours.

d. A minimum of two scheduled preventative maintenance calls per year.

e. A malfunction incident report shall be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following:

i. date and time notified

ii. date and time of arrival

iii. serial number, type and model number of equipment

iv. time spent for repair, and

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

f. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 2% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government 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 98% in each month of the term of the agreement.

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

h. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, 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 problems with the instrumentation may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another 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. The vendor must 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 must be provided as they become commercially available and at the same time as they are being provided to commercial customers.

i. Ancillary support equipment - The vendor will provide, install and maintain, as indicated, any and all ancillary support equipment to fully maintain the molecular analyzer as defined in these specifications, e.g. installation of telephone lines for modem operations, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc.

j. Invoicing – All invoices shall be issued monthly in arrears stating the test name, monthly volume of patient reportable results and the individual cost per reportable price as awarded per contract. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge will not be accepted.

k. Commercial offerings - The vendor will provide to the VA facility any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software.

6. PROPOSALS

I. Vendors are asked to submit their base proposals outlining the proposed reagents for the tests included below. This configuration should be based on the vendor’s best recommendation that meets the operational activities and required efficiencies and productivity of a laboratory of the size and scope defined herein.

II. Vendors must provide in their offer the following:

a) Cost-per-test or cost-per-kit for the test menu defined below for the Washington DC site.

b) Cost per Reportable Result for the test defined below for the Washington DC site.

c) Commercial literature and other information describing their compliance with the technical specifications. If the commercial literature does not directly address specific specifications identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format.

III. Each molecular testing kit must include a minimum of two levels of commercial controls and or a set of reagent specific calibrators sufficient to perform enough calibrations and daily QC to last thru the usage of the whole kit.

IV. Vendors that offer multiple types of repair service packages that are different than the minimum requirements stated in the specifications are encouraged to offer an associated adjusted price per reportable.

V. Vendors offering third party products (reagents or consumables) where the cost is included in the CPT must individually specify the product, source and reference information, indicate whether the third-party reagents will be procured by the offeror and the costs are included in the quoted CPT and certify their technical support of the third-party method on their equipment systems.

7. ORDERING/DELIVERY:

Department of Veterans Affairs Washington DC VA Medical Center 50 Irving Street NW

RM GB-105

Washington, DC

Test Menu and Annual Usage:

Ancillary Supplies

Kit, Aptima Specimen Transfer

Advanced Cleaning Solution

Spare Caps, AMP/Probe

Multi-Tube Unit (MTU) Kit Assay

Aptima Auto-Detect

Aptima Assay Fluid

Waste Bag Kit

Waste Bin Cover/Deflector

Spare Caps, TCR

Aptima HPV External control

Aptima Penetrable caps