ATTACHMENT B.docx

Southern Arizona VA Health Care System Pathology & Laboratory Medicine Service

SCOPE

The Southern Arizona VA Healthcare System (SAVAHCS) Diagnostics Division requires an automated processing and continuous sample loading analyzer to expand the testing menu for allergy and autoimmune disease. Currently, testing is sent to reference a laboratory. This will decrease turnaround time for patient results and increase quality of patient care.

GENERAL REQUIREMENTS

I. Analyzer Requirements

1. The vendor shall provide the most current allergy and autoimmune platforms available, with an ability to detect and minimize the effects of interfering substances such as lipemia, icterus, and hemolysis.

2. Throughput of a minimum of 50 results/hour

3. Continuous random-access loading

4. The analyzers shall have a comprehensive QC Program for all tests which includes at a minimum the following options:

· On-board quality control data storage and reporting capabilities

· The ability to view and print daily and monthly QC results.

· Westgard rules (or other QC acceptance criteria)

5. System shall have a design that removes the possibility of reagent or sample carryover.

6. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover.

7. System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency.

8. Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime.

9. Interfacing Responsibilities

a. System interface requirements and specs provided to Customer by Contractor

b. Customer opens ticket or starts project with middleware/LIS techs or third-party vendor.

c. Customer/middleware/LIS techs/third-party vendor builds/maps tests.

d. Customer network/IT/infrastructure sets up networking infrastructure as needed.

e. Customer network/IT provides network specs to Contractor (if TCP/IP LIS)

f. Contractor provides firewall per specs (if TCP/IP LIS)

g. Contractor/customer installs firewall (if TCP/IP LIS)

h. Contractor/customer conduct dry/wet testing of interface

10. Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution.

11. Vendor to inform VA if reagents to be discontinued ninety (90) days prior to going off the market.

12. Equipment shall have accurate capability of monitoring reagent usage and provide reagent inventory upon request, in real time.

13. The system shall be a well characterized system with multiple studies and have a track record of performance no less than one year.

14. The operating system must be Windows 10.

II. Test Menu Requirements

1. The test menu for allergy and autoimmune disease testing shall include, but not limited to the following:

a. Beta 2-Glycoprotein IgG

b. Cardiolipin IgG

c. Tissue Transglutaminase IgA, Tissue transglutaminase IgG, Gliadin IgA, Gliadin IgG

d. Cyclic Citrullinated Peptide (CCP)

e. Rheumatoid factor IgM, Rheumatoid factor IgA

f. Double-stranded DNA autoantibody, Ribosomal-P protein autoantibody, SS-A IgG autoantibodies, SS-B IgG autoantibodies, SM (Smith) IgG autoantibodies, Ribonucleic protein IgG autoantibody, Jo-1 autoantibody, Centromere B autoantibody, SCL-70 IgG autoantibody, RNA polymerase III autoantibodies.

g. Myeloperoxidase Antibody (MPO)

h. Proteinase 3 Antibody (PR3)

i. Anti-Mitochondrial Antibody (AMA)

j. Anti-Thyroglobulin (Anti-TG)

k. Anti-Thyroid Peroxidase (Anti-TPO)

l. Allergen testing to include Horse dander IgE, Cow dander IgE, goose feathers IgE, chicken feathers IgE, mouse urine protein IgE, Egg white IgE, Cow’s milk IgE, Codfish IgE, Wheat IgE, Peanut IgE, Soybean IgE, Shrimp IgE, Walnut IgE, Scallop IgE, Sesame seed IgE, Hazelnut IgE, Cashew nut IgE, Almond IgE, Salmon IgE, Tuna IgE, Cladosporium herbarum IgE, Aspergillus fumigatus IgE, Mucor racemosus IgE, Candida albicans IgE, Alternaria alternata/tenuis IgE, Cat epithelium/dander IgE, Dog dander IgE, Bermuda grass IgE, Rye-grass IgE, Cockroach IgE, Dermatophagoides pteronyssinus IgE, Dermatophagoides farina IgE, Cladosporium herbarum IgE, Mountain juniper/cedar IgE, Olive IgE, Cottonwood IgE, Saltwort/Russian thistle IgE, Pigweed IgE, Oak IgE, Elm IgE, Johnson grass IgE, Mugwort IgE, Penicillium chrysogenum IgE, Acacia IgE, Short (common) ragweed IgE, Box Elder IgE, Grey alder IgE, Timothy grass IgE, Mulberry IgE, Pigweed IgE, Sheep sorrel IgE, Pecan nut IgE, Macadamia nut IgE, Brazil nut IgE, Pistachio IgE, Walnut IgE

2. The vendor shall provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing analyzers.

III. INSTALLATION AND VALIDATION

1. Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of VA staff. Test counts for billing will begin after review/approval of all correlation/linearity studies performed at installation.

2. During installation/set-up, and when bringing new tests on-line, a technical support specialist shall perform all validation studies including installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours on a Monday-Friday via customer telephone support.

3. Throughout the life of the agreement, manufacture technical support shall be provided 8am-8pm EST Monday – Friday.

4. The vendor shall provide/install any routine items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to printers, water supply, drainage systems, UPS, and surge suppressors.

IV. TRAINING

1. The vendor shall provide (on-site, off site) primary user training for a minimum of two users per instrument with on-site training available to remaining users on all tours with competency assessment performed and documented. Primary user training shall be arranged by the vendor and include all costs of off-site training, i.e., transportation (air and ground) and room and board.

2. Vendor shall provide/install/train users on manufacture’s data management system with either off site or in house training.

3. Vendor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals. Procedures shall be in the Clinical and Laboratory Standards.

V. SERVICE AND MAINTENANCE

1. Vendor to provide twelve (12) month warranty.

2. The vendor shall provide technical support Monday - Friday 8am-8pm EST.

3. Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level.

4. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required.

5. Preventive maintenance and Service contract to begin after twelve (12) month warranty has expired for four (4) years.

6. Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g., upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).

7. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals.

VI. OTHER

1. Assessment of testing needs/menus shall be evaluated as needed by the laboratory with communication to the vendor to receive pricing. There shall be easy assimilation for new tests into the pricing test lists without the need for line-item additions to the agreement.

2. Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory 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 another analyzer(s) that can produce the required criteria satisfactorily to the user. This is to be handled according to the terms and conditions of the standard warranty as well as the terms and conditions of the purchased service agreement.

3. The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. The vendor will discuss the need to send out to a reference laboratory when testing is not available for an extended period of time and shall be mutually agreed upon and evaluate if reimbursement is required.

4. In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor 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 from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. So long as facility has provided for the correct receipt and storage in consumables and/or reagents that require correct temperature storage. In the event that any reagent, consumable or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 business hours after receipt of the verbal order for priority delivery from the facility so long as notice is provided prior to reagent shipping cutoff time at contractor facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

5. This contract shall “be green,” by eliminating, minimizing, or mitigating adverse environmental impacts. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals:

a. Benzene

b. Carbon tetrachloride

c. Methyl isobutyl ketone

d. Chloroform

e. Dischloromethane

f. Methyl ethyl ketone

g. Toluene

h. Methyl isobutyl ketone Xylenes

i. Tetrachloro-ethylene

j. Cadmium

k. 1,1,1-Trichloro-ethane

l. Chromium

m. Trichloro-ethylene

n. Cyanide

o. Lead

p. Mercury

q. Nickel