P01 SOW VANEC Automated Colorectal Cancer Screening 4.18.24.docx

VANEC VISN 1,2,4, & 5 Facilities Automated Colorectal Cancer Screening Fecal Occult Blood Immunoassay Statement of Work

A. BACKGROUND AND SCOPE:

The Pathology & Laboratory Medicine departments of VA North Eastern Consortia (VANEC) supporting VISNs 1,2,4 & 5 has a need to standardize the colorectal cancer screening test. Currently there are two tests that have different sensitivities which may lead to variances in results. VANEC VISNs are expanding the colorectal cancer screening and it is imperative that the testing method be automated to minimize the impact of the workload increase.

The VANEC VISNs 1,2,4 & 5 Pathology & Laboratory Medicine departments are looking for an IDIQ firm fixed price for an automated fecal occult blood analyzer to perform testing on our patient population. The contractor shall provide all equipment, reagents, standards, controls, supplies, consumables, parts, accessories, and any other item required for the proper operation of its contractor-owned automated fecal occult blood analyzer and the generation of results on a Cost per Test (CPT) basis. The contractor shall also provide any required items not included in the CPT program like personal mailers, sampling bottles and thermal paper.

The contractor shall provide automated testing to all VANEC VISNs 1,2,4 & 5 facilities. Currently Testing must be equal or equivalent to the instruments already in use in Equipment in the VANEC VISNs 1,2,4 & 5 facilities and shall be replaced if is more than five years old or if is not in excellent conditions. Replacement of equipment shall be coordinated with each Facility POC.

The contractor shall perform to the standards in this contract.

B. PRICING SCHEDULE

1. Cost Per Test Basis: Refers to a pricing arrangement intended to allow the ordering facility to generate a single patient test result for a given test. The CPT pricing includes the cost of reagents, related products (e.g., latex reagent, calibration, controls, consumables and one (1) collection device.) and equipment. Excludes components for mailing of samples to the testing facility. The collection devices are paid for up front and then credited back based on actual monthly CPT volume. It will also include material to perform quality control, calibration, and correlation studies as prescribed by the Clinical and Laboratory Standards Institute (CLSI), all necessary maintenance to keep the equipment in good operating condition (both preventive and emergency repair), and training for government personnel.

A schedule of items offered and per item cost should be included as a separate attachment to contractor’s offer.

2. Contractor is guaranteed a minimum order of $2,000, not to exceed $2,500,000. The Government does not guarantee the maximum estimated quantity. Refer to Attachment #1 for yearly projections and Period of Performance.

C. REQUIREMENTS

1. General Requirements

a. 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 VANEC VISNs 1,2,4 & 5 VAMCs. The historical annual volume cited shall be utilized by interested contractors to submit their cost proposal.

b. A listing of estimated yearly quantities required by each VISN is in Attachment 1 (Test Volumes). Quantities are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. There is no guarantee maximum.

c. The pricing shall be based on new state of the art equipment. Remanufactured or used models will not be accepted. The vendors’ offered automated Fecal Occult Blood Immunoassay analyzer shall conform to available existing space.

d. The analyzer/equipment shall meet the test volume in Attachment 1 (Test Volumes) and match or improve the turnaround time requirements (per laboratory guidelines). The system shall streamline all aspects of testing, thereby enhancing operational efficiency, supporting improved patient outcomes, and improving the productivity of the VANEC VISNs 1,2,4 & 5 .

e. Footprint of system shall be small and fit on a typical laboratory countertop (i.e.., at least 24” deep x 24” wide x 12” high to a maximum of 30” deep x 32” wide x 24” high)

f. Vendors shall provide the VANEC VISNs 1,2,4 & 5 facilities with Food and Drug Administration (FDA)-approved 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 in their submission to the RFP.

2. SYSTEM REQUIREMENTS

a. 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 result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

b. 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. Vendor to provide documentation supporting these claims.

c. 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. Vendor to provide manufacturer verified documentation of sample stability for a minimum of 14 days.

d. 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 envelope. Vendor shall work with each facility to develop an acceptable system to meet the needs for postage and addressing mailing envelopes of that facility.

e. Vendor shall specify calibration frequency and time required to perform calibration.

f. Vendor to provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements. Vendor to specify requirements for frequency of quality control testing.

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

h. All consumable supplies (reagents, standards, controls, disposables, 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 the Fecal Occult Blood Immunoassay analyzer.

i. The contractor shall maintain, at each participating station within VANEC VISNs 1,2,4 & 5 , 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).

j. The system shall have a design that supports the result integrity removing the possibility of sample carryover. Vendor shall provide documented evidence confirming the system design removes the possibility of any sample carryover.

k. The vendor shall state the on-board reagent stability.

l. The vendor shall list all reagents needed for Fecal Occult Blood Immunoassay testing, state if the reagents are stored at room temperature or refrigerated, and state the format/size of reagents.

m. The vendor is to define the actual hands-on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The vendor is to include the analyzer/technologist time required to perform each maintenance task. The vendor shall list which tasks are user level and which tasks are service level.

n. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50- and 90-degrees Fahrenheit (10 to 30 degrees Celsius).

3. INSTRUMENTATION AND SOFTWARE

a. The equipment shall include 120-volt UPS that has a 2–3-hour back-up capability.

The vendor shall be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed.

b. The system shall 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.

c. The system shall have a barcode reader for sample identification. The barcode Reader must be able to read current standardized VA barcode formats.

d. The system shall be able to store and retransmit records (24 hours of maximum instrument throughput.) The vendor is to state how many samples’ results can be stored.

e. The vendor shall provide all upgrades to the equipment hardware, 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 two months of their issuance or date of first commercial availability. The vendor shall provide all service and maintenance to VANEC VISNs 1,2,4 & 5 facilities for all Polymedco analyzer model(s) that are utilized.

f. Requests for additional instrumentation, upgrades, or replacement, due to workload increase, excessive instrumentation/test kit failures/malfunctions, breakdowns, or service calls will be evaluated as needed and annually by the facility POC with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/test kits supplied may indicate probable noncompliance with the terms of this contract and will entitle the VANEC VISNs 1,2,4 & 5 facilities to replacement with equipment/test kits that can produce the required criteria of this contract satisfactorily to the user.

g. The contractor shall remove all equipment within 90 days after notification of the expiration of the terms of this contract but not until the completion of new equipment installation inclusive of completed cross over studies. VANEC VISNs 1,2,4 & 5 facilities will be responsible for the removal and sanitation of the hard drive at the time of analyzer removal/upgrade. The hard drive will be retained for this purpose at no additional cost to the Government.

h. 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).

4. INSTALLATION AND VALIDATION

a. The vendor shall list analyzer/utility requirements (electrical, water, plumbing, reagent and bio-hazardous disposal, etc.). The vendor shall provide weight and dimensions of proposed analyzer.

b. The vendor shall indicate any routine and/or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to paper, printer cartridges, drainage systems, surge suppressors, UPS, etc. Any items excluded by the vendor shall be delineated in their proposal. The cost of the excluded items must be incorporated in the price proposal.

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

1. 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 analyze 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.

2. Precision study using negative and positive control material: This will consist of a within run precision study of 10 negative and 10 positive controls.

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

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

5. 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.

d. The vendor shall provide the VANEC VISNs 1,2,4 & 5 facilities with all reagents, calibrators, controls, linearity material, 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 required studies, performed at installation of new equipment, are reviewed, approved, and the analyzer has been placed in use for patient testing.

e. 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, linearity, and cross-over studies. Evaluation/comparison data shall be sufficient to satisfy accreditation 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 and training for a minimum of 40 hours during regular office hours on a 5 days/week basis.

f. The vendor shall provide equipment installation and possible reinstallation costs if the equipment is required to be moved due to construction or laboratory redesign.

g. 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 through a monthly or quarterly standing order have at least a six-month expiration date. The vendor shall work with each VANEC VISNs 1,2,4 & 5 facility POCs to adjust reagent supply based on workload changes and to provide the option annually for the facility to adjust the shipment table. The vendor shall state what their policy is regarding adjusting a standing order or ordering an additional shipment of supplies.

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

a. Vendor will provide technical support services at no additional charge to the each participating station within VANEC VISNs 1,2,4 & 5 . 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 engineer (FSE) shall provide on-site service response within 24 hours after being contacted. 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.

b. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of troubleshooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facilities staffing.

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

d. Requests for services will be through one contractor.

e. The vendor shall provide on-site instrument support service sufficient to provide assistance with troubleshooting and repair of the analyzer. The vendor may list the service options available. The support service shall follow-up all calls within 1 hour.

At all times, the FSE shall keep the facility informed of the timeline for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility/clinic) within 24 hours from the time the FSE arrives.

f. The vendor shall pay for the laboratory testing at a reference facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the participating VANEC VISNs 1,2,4 & 5 facilities for a total of more than 24 hours. The cost incurred from the reference facility testing, packaging, and shipping will be applied to the invoice in the form of a credit or deduction. Downtime for each incident shall start from the time the facility makes a bona fide attempt to contact the vendor’s designated representative until the analyzer is returned to good operating order.

g. 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 24 hours after receipt of the verbal order for priority delivery to the Government. If either circumstance has occurred, the contractor shall deliver to the VANEC VISNs 1,2,4 & 5 facilities, 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 is 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.

h. 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.

i. 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.

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

k. The vendor’s technical service representatives must comply with each of the participating facilities within the VANEC VISNs 1,2,4 & 5 facility’s requirements for onsite vendor representatives.

6. TRAINING AND PROCEDURES

a. Vendor must provide all education/training on site during installations or following updates to the equipment. Training must include basic operation, quality control, interpretation, 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.

b. Provide initial in-depth training for two key operators at each site. Key operator training is to include all costs of off-site training. It shall include at least transportation (air and ground), room and board.

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

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

7. PAST PERFORMANCE / TECHNICAL EXCELLENCE

a. The vendor shall provide four references: two VA and two from the private sector. References to include the address, telephone number, and contact person’s name which can validate past experience within the last three (3) years regarding:

1. Quality of Service (to include timeliness of service, documentation (service report), communication of work/repair at time of service, does service repair/fix the problem on the first site visit or does service have to return to repair/fix the problem again, are parts/tools available when service is performed or is service delayed due to ordering replacement parts, and technical support including method validation.

2. Ability of vendor to supply accurate data for annual contract renewal by required time frames and timeliness of billing reconciliation.

3. Customer satisfaction: meets or exceeds turn-around with negligible downtime and can introduce STATS with minimal intervention.

b. The vendor shall supply the national average of service calls per analyzer per year.

c. The vendor shall list reagent recalls/bulletins within the last five years. The vendor shall list any product unavailability due to manufacturing issues within the last five years.

d. The vendor may list the number of new tests/features introduced within the last 3 years or any technology updates.

e. The proposed equipment shall have at least one-year proven experience and be available on the Federal Supply Schedule.

8. VALUE-ADDED CHARACTERISTICS

a. These characteristics are not mandatory, but will be considered as value-added in the Best-Value Determination. Value added characteristics may include, but are not limited to:

1. System has a data management system that allows the user to monitor and analyze data and quality control. System includes flags for unusual results and failed quality control.

2. Include electronic operating manuals and troubleshooting guide as well as a preventive maintenance guide and log.

3. Vendor shall state what steps they are taking to conserve natural resources that will enable their customers to become more energy efficient, environmentally friendly, and competitive.

9. OTHER TERMS AND CONDITIONS

a. Unless otherwise agreed upon by both parties, Terms and Conditions of this contract will be determined by the vendor’s current Federal Supply Schedule contract with the General Services Administration or VA National Contract Center.

b. All pricings shall be based on and shall not exceed the vendor’s most current FSS contract pricing for supplies offered.

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

ATTACHMENT #1 VANEC VISNs 1,2,4 & 5 Facilities’ Estimated Projections

Credit for Devices

OCS2 Sampling bottles (20x50 sampling bottles)