Statement of Work - Blood Culture.pdf

STATEMENT OF WORK

Blood Culture Detection Instrument

1. INTRODUCTION/BACKGROUND:

The purpose of this activity is to acquire a Blood Culture and Detection Instrument Services for the Clinical Laboratory at the Ralph H. Johnson

VAMC.

2. OBJECTIVE:

a. Obtain a Blood Culture and Detection Instrument, Reagents, and Service, for testing Clinical Laboratory specimens on a reagent rental agreement (Cost Per Test/Cost Per Reportable).

b. Provide one (1) Blood Culture and Detection Instrument, Reagents, and

Service on a base year plus four (4) option years fixed price contract.

3. MAJOR REQUIREMENTS:

a. Blood Culture system must have an automated culture bottle loading feature in support of a closed incubator system.

b. Blood Culture system must have an automated negative culture bottle unloading feature in support of a closed incubator system.

c. Blood Culture system must have an automated positive culture bottle unloading feature in support of a closed incubator system.

d. Blood Culture system must have an automated bottle fill detection and reporting system.

e. Blood Culture system must have electronic communication established with the existing Myla Middleware Information System for demographics reporting, the vendor shall provide technical support personnel to assist the RHJ VAMC with connectivity.

f. Instrument/Middleware connectivity to the Laboratory Information System

(VISTA) is preferred. When middleware connectivity to the LIS is available, the vendor shall provide technical support personnel to assist the RHJ VAMC with connectivity.

g. The Blood Culture system and/or middleware must promote efficient retrieval of microbial culture data and statistics.

h. The vendor shall be responsible for the delivery and installation of all equipment.

i. The vendor shall provide a technical representative to assist with initial validation of all equipment services provided. The technical representative will perform validations on site, unless otherwise specified in a contractual agreement.

j. The vendor shall provide instrument service/repair and routine maintenance.

Vendor response for unscheduled instrument downtime should be less than 24 hours, unless otherwise specified in a contractual agreement. All cost associated with instrument service/repair and routine maintenance shall be included in the reagent rental pricing.

k. The vendor shall provide service/reagents for:

- One (1) Blood Culture instrument per year.

- ~ 6000 aerobic culture bottles per year.

- ~ 6000 anaerobic culture bottles per year.

l. The vendor shall provide training to clinical laboratory staff for use of the test system. All cost associated with staff training shall be included in the reagent rental pricing. Training may include initial instrument training, and/or supplemental training for related purposes.

4. GOVERNMENT FURNISHED INFORMATION OR MATERIAL:

There are no Government furnished materials in support of this contract activity.

5. MEETINGS AND REVIEWS:

The vendor shall meet with Pathology and Laboratory Service Personnel on an as needed basis. Pathology and Laboratory Service may request meetings to occur by telephone or in person at the Ralph H. Johnson VAMC.

6. TRAVEL REQUIREMENTS:

All cost associated with travel for instrument service/repair, routine maintenance, meetings, or employee training shall be included in the reagent rental pricing.

7. CONTRACTING OFFICER'S REPRESENTATIVE (COR):

a. The COR is Robert Haynes, phone 843-789-7531.

b. No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification.

8. REPORTS/DELIVERABLES:

a. Deliverables – One (1) Blood Culture and Detection Instrument platform.

b. Deliverables – Middleware/Software for Blood Culture System connectivity/communication with Myla and Laboratory Information System.

c. Deliverables – Reagents Bottles as needed or quarterly basis.

d. Deliverables – Technical Representative for system validation.

e. Deliverables – Training for Laboratory Staff.

f. Deliverables – Technical Service for Periodic Maintenance and Repairs.

9. PERIOD OF SERVICE:

Periods of service will be performed in base years and option years.

10. CONTRACTOR QUALIFICATIONS:

The successful contractor shall be able to provide an FDA approved test system to fulfill the test requirements listed in the Statement of Work.

11. SECURITY/NATIONAL AGENCY CHECK REQUIREMENTS:

The contractor shall provide/submit any national security requirements requested by the Information Security Officer(ISO), Privacy Officer(PO), Contracting Officer(CO), or other VA Authority.

The certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required.