Atch_1_-_Specifications.pdf

Urinalysis Requirement Specifications

The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) benchtop Urinalysis system consisting of two (2) analyzers: one (1) fully automated primary analyzer with automated chemistry and urine sediment analyzer and one (1) backup analyzer with at least semi-automated functionality. The requirement must include reagents to perform 12,000 urinalysis specimens and 3,600 microscopic specimens annually (1000 and 300 per month, respectively) for 5 years (base plus 4 one-year options).

Proposal must include equipment training as follows: Initial training (upon award) for two (2) key operators including lodging (hotel), per diem, and travel (airfare) expenses to/from Keesler AFB and training location (offsite location). Non-Initial additional training: Upon request, training for one operator per year per instrument. (If offsite, include lodging (hotel), per diem, and travel (incl. airfare) expenses to/from Keesler AFB and training location). Non-initial training only: If training is equivalent to original equipment manufacturer (OEM) training, alternative training delivery (i.e., distance training) may be substituted in lieu of offsite, in-person training.

The contract will include all calibrators, controls, and reagents as well as all instrument installation, setup and validation, supplies and labor. Periodic maintenance and 24/7 technical support (with local service personnel preferred) included along with all replacement parts, supplies and labor. Response to service needs not later than 24 hours and resolution not later than 48 hours from report of service need. The contract must include a backup analyzer and all reagents/supplies needed to perform testing in the event the primary analyzer is down for repairs or maintenance. Reagents must be billed and shipped as needed.

Any software requirements to meet requests must be included in contract price.

Instruments must be installed, validated and ready for patient testing by 31 December 2018 to begin patient testing on 1 Jan 2019. This includes all correlation, precision, linearity, normal range and any other required validation studies. The information and data must be provided to the Urinalysis management staff electronically and in a binder. NOTE: Current contract ends 31 Dec 2018.

Primary analyzer requirements:

1. Fully automated analyzer with the capability of performing automated chemistry testing.

2. Must test for 10 urine chemistries, specific gravity, color and clarity.

3. Fully automated urine particle analyzer. Must be able to perform accurate counting of WBCs and

RBCs and automatically extensively classify formed elements and flagged parameters.

4. Must have bi-directional interface capable of connecting to and working with the laboratory information system, Composite Health Care System (CHCS)

5. Must have minimal (<15 mins) hands-on daily, weekly and monthly periodic maintenance.

6. Must be able to perform positive identification of patient samples.

7. Must have the capability to define criteria for reflex urine particle analysis based on user defined chemistry results.

8. Must have capability to auto-verify results based on user defined rules.

9. Must be able to level sense samples.

10. Must accurately detect bacteria as a screening for Urinary Tract Infections. Negative predictive value must be >95%

11. The analyzers must meet all necessary power and waste requirements as dictated by the current laboratory work space. Power requirements are 120VAC, 60 Hz. Overall maximum width is 120 inches for all equipment (chemistry and sediment analyzer together max width is 63.5 inches located in center of overall space), 37 inch depth, 41 inch height (from countertop level) space limitation.

System will be installed on existing countertop. Height limitation from counter level. Waste to be plumbed to drain tube at rear of analyzer.

FA301018R0035 Urinalysis Specifications - 11 Sep 2018

Back-up analyzer requirements:

12. Semi-automated, at minimum.

13. Must perform chemistry testing automatically and have the capability to connect to the urine particle unit during downtime of the primary chemistry analyzer.

14. Must test for 10 urine chemistries, specific gravity, color and clarity.

15. Must have bi-directional interface capable of connecting to and working with the laboratory information system- Composite Health Care System (CHCS)

16. Must have minimal (<15 mins) hands-on daily, weekly and monthly periodic maintenance.

FA301018R0035 Urinalysis Specifications - 11 Sep 2018