Amendment_0001_SOW_7_25_2016_Testing.pdf

INSTRUMENTATION (Molecular Testing) SYSTEM FOR THE PHOENIX INDIAN

MEDICAL CENTER (PIMC)

A. INTRODUCTION:

The Contractor shall provide an instrument that performs fully automated, on-demand molecular testing for the presence of Neisseria gonorrhea and Chlamydia trachomatis (GC/CT) from The ThinPrep PAP TEST and urogenital specimens; in a self-contained instrument environment.

B. BACKGROUND:

To have available to the PIMC a instrumentation system that performs fully automated, on-demand molecular testing for the presence of Neisseria gonorrhea, Chlamydia trachomatis (GC/CT), Human Papillomavirus (HPV) and HPV genotyping from The ThinPrep PAP TEST, urogenital (endocervical and urethral) specimens and male/female urine specimen; in a self-contained instrument environment. This testing service will be provided to all departments and outpatients clinics of the PIMC.

C. SCOPE OF REQUIREMENT:

The Contractor shall provide One (1) Panther Molecular Diagnostic Instrument System (or equivalent system), that performs fully automated, on-demand molecular testing for the presence of Neisseria gonorrhea and Chlamydia trachomatis (GC/CT) from The ThinPrep PAP TEST and urogenital (endocervical and urethral) specimens with the following features:

• Fully automated specimen results.

• Primary tube sampling.

• Random access (on-demand/non-batch) sampling. Instrument must be capable of running one test after another without having to wait for the instrument to analyze the previous specimens first. The instrument must be capable of allowing specimens to be placed on the machine continuously one right after another ir-regardless of whether the previous specimens have been completely analyzed.

This would require the instrument to perform testing on demand and not run specimens in a batch format.

• QC valid for 24 hours (not required with each patient specimen)

• Load-and-go with unattended result processing.

• STAT test prioritization.

• Automatic decontamination and removal of amplification tubes from assay area.

• Self contained instrument that does not require a “clean room” environment.

The Contractor shall provide an instrument that is capable of bi-directional interface with our middleware and Laboratory Information System Interface (LIS).

The Contractor shall provide an instrument that must have direct tube sampling capability of primary tube with no-cap removal.

The Contractor shall provide an instrument that must be able to automatically decontaminate and remove amplification reaction tubes from assay processing area without operator intervention in a closed environment.

The Contractor maintains “24/7/365” (including holidays and weekends) response to service calls and contractor responds within 12 hours of the initial service call and contractor has problems resolved on site within 24 hours of the service call.

The Contractor shall provide Reagents and Consumables as detailed in Paragraph D that is required to perform testing on the Panther instrument.

The instrument shall perform fully automated testing (no specimen prep) that reduces the technologist time to perform the test from 3-4 hours to less than one hour.

The instrument shall perform on-demand testing (random access/non-batching) that greatly reduces turn-around times for test results. Specimens can be loaded, and testing performed, as they are received throughout the day, with test results available in hours instead of days.

The instruments’ QC (quality control) shall be valid for 24 hours and does not need to be run with each patient specimen. Therefore, after passing QC, the instrument can run unlimited specimens during a 24 hour period without having to re-run QC.

The instrument shall perform automatic decontamination and amplification tube removal without operator intervention which improves safety and eliminates operator-sourced contamination.

Due to space limitations, the instrument that performs the testing shall be in a self-contained environment, eliminating the need for a separate “clean room.” This reduces the total space required for the instrument and sample prep to the footprint of the instrument itself instead of the 240 feet we currently require.

To acquire the equipment above, at no charge, under the condition to purchase supplies identified in Paragraph D for a period of performance under this contract.

PIMC shall continue to purchase reagents and consumables for a period from 9/1/15 through 2/29/16.

Reagents:

The Contractor shall provide, when needed, expedited delivery of reagents, consumables and supplies identified in Paragraph D.

The Contractor shall provide high quality reagents and consumables free of defects.

The Contractor shall provide a designated sales representative to account to help resolve technical and/or contractual issues.

The Contractor shall provide a designated customer service person to handle all problems that arise with the ordering of reagents and consumables.

The Contractor must deliver items listed/requested within 7 days of ordering.

The Contractor must provide notification to the IHS for items placed on backorder for more than 7 from the date ordering.

If there are any changes in product availability and production and/or specifications, the Contractor shall provide a notice in writing to the Designated Project Officer cited in Paragraph G, 60 days in advance.

The Contractor must be able to fulfill urgent delivery requirement for overnight delivery.

The Contractor must allow return or provide a full credit for items with expiration dates allowing for an unreasonable self-life. Return shipping is the responsibility of the Contractor.

D. ESTIMATED ANNUAL QUANTITIES:

Estimated Annual Test Quantities:

Item Description Unit Total Units

1 Aptima CT/NG EA 13,300 2 Aptima HPV EA 3,500 3 Urine tubes EA 1900 4 Unisex swabs EA 3900

5 LPT EA 5,300

6 Aptima HPV Genotyping 16,18/45 EA 4,000

E. SHIPMENT:

Contractor shall identify the IHS purchase order number on all packing slips for tracking and payments purposes. Failure to list the IHS purchase order number may cause payment delays.

F. PERIOD OF PERFORMANCE:

The Contractor shall provide reagents and consumables for purchase by PIMC and continued use of the Panther Molecular Diagnostic Instrument System Alert Instrumentation System.

G. DESIGNATED CONTRACTING OFFICERS REPRESENTATIVE (COR):

Adrienne Frazier, Laboratory Manager, PIMC Laboratory Department, Telephone No.

(602) 263-1438, email address: Adrienne.Fraizer@ihs.gov, is hereby designated the COR to monitor the requirements of this order on behalf of the government.

1. The Contracting Officer shall designate the COR representing the Government for the purpose of this contract in writing. Such designation will set forth the duties specifically delegated in regard to the performance of this contract. A copy of the designation will be provided to the contractor.

2. The major responsibility of the COR is to ensure Contractor accountability, monitor contract performance, and assist the Contractor in the resolution of program problems encountered during the performance of this contract.

3. The COR shall be responsible for:

a) Monitoring the Contractor’s technical progress, including the surveillance and assignment of performance and recommending to the contracting Officer changes in requirements;

b) Interpreting Statement of Work;

c) Performing technical evaluation as required;

d) Performing technical inspection and acceptance required by the contract;

e) Assisting the contractor in the resolution of technical problems encountered during performance.

The COR’s responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder. The COR does not have the authority to change or alter the order amount, terms and conditions.

H. PIMC POINT OF CONTACT:

Adrienne Frazier

Telephone: (602) 263-438 Laboratory Manager Email: Adrienne.Frazier@ihs.gov

PIMC Laboratory Department 4212 N. 16ths Street Phoenix, AZ 85016

I. CONTRACTOR POINT OF CONTACT (TO BE DETERMINED):

mailto:Adrienne.Fraizer@ihs.gov mailto:Adrienne.Frazier@ihs.gov