ATTACHMENT B SOW - AUTOMATED ESR TESTING.docx

Southern Arizona VA Health Care System Pathology & Laboratory Medicine Service

SCOPE

The Southern Arizona VA Healthcare System (SAVAHCS) Pathology and Laboratory Medicine Service (PALMS) requires an Erythrocyte Sedimentation Rate (ESR) testing in an automated platform that samples directly from an EDTA whole blood collection tube as is used in Hematology for Complete Blood Count (CBC) testing.

GENERAL REQUIREMENTS

I. Equipment/Analyzer Requirements

1. A system that provides an automated ESR result using random access direct tube sampling from an EDTA whole blood tube.

2. The system should require as little sample as possible, preferably less than or equal to 500 ul whole blood or 100ul aspirated volume.

3. Twenty (20) samples with random access loading.

4. The system must be able to deliver a result in less than 15 minutes and not be affected by hematocrit.

5. The system must use two levels of assayed control performed on a 24-hour basis (each day of use).

6. The system must have automated closed tube sampling and positive barcode reading identification.

7. The system should be interfaceable with Data Innovations Instrument Manager in a unidirectional manner using only the Vista assigned accession number as an identifier, no PII or PHI is involved using a native ethernet connection. The C&A requirements do not apply and that a security accreditation package is not required.

8. Direct sampling is required to avoid blood exposure to the operator

9. Low blood volume is required to allow collection in the same tube as the CBC as well as other possible tests such as a Hemoglobin A1c.

10. The system must have a maximum footprint of 24 square inches and a maximum height of 20 inches.

11. It must use a standard 120v AC power source

12. It must have a positive identification system using standard barcode labels (coda bar).

13. It must use a standard 13x75mm capped EDTA tube as the primary sample tube

14. The system should represent the latest technology and have FDA approval.

15. The system should have an alarm system in place for regular maintenance issues such as tubing change or piercing needle replacement.

II. Test Menu Requirements

1. Test card that has either 250, 1000, 2000, or 5000 tests.

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. SAVAHCS will install the equipment with internal personnel.

2. Validation will be performed by laboratory staff directed and assisted by the vendor.

3. The vendor must provide a validation report covering correlation, accuracy, precision, and carryover study.

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

5. 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. Holidays Only emergency service shall be provided on National Holidays and only if authorized by the POC in advance as approved in the delegation of authority.

When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

V. TRAINING

1. Training will be internally performed by SAVAHCS personnel.

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

VI. 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 if applicable.

VII. 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 may entitle the facility/clinic to its replacement with another analyzer(s) if determined necessary by both the Government and Contractor 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 for an extended period of time as agreed upon by both the Government and Contractor through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages if applicable, may be applied to the invoice in the form of a credit. 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 business 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