Salient Characteristics.docx

Salient Characteristics

Requirements of Services to be provided:

Basic Requirements: The system(s) must contain random access technologies that improve workflow and be approved by, and include test methods approved by, the Food and Drug Administration (FDA). The system(s) must fit in the current space available which is approximately 70 inches (height) x 150 inches (length) x 50 inches (width/depth).

Test Menu and Special Requirements for Awarded Contractor: Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum, by any change in instrumentation. Vendor must meet (or improve) Limit of Detection (LoD)* requirements defined for each assay as listed below. Listed testing requirements must be capable of completion in under 120 minutes from start time (time of loading onto instrument). Proposal should include automated molecular processing for:

· Cytomegalovirus (CMV) with minimum LoD in the following concentrations:

· 350 u/mL: 34.5 IU/mL

· Hepatitis B Virus (HBV) with minimum LoD in the following concentrations:

· 200 u/mL: 15.5 IU/mL 500 u/mL: 6.6 IU/mL

· Hepatitis C Virus (HCV) with minimum LoD in the following concentrations:

· 200 u/mL: 40 IU/mL 500 u/mL: 15 IU/mL

· Human Immunodeficiency Virus (HIV) with minimum LoD in the following concentrations:

· 200 u/mL: 40 IU/mL 500 u/mL: 15 IU/mL

· Epstein-barr Virus (EBV) with a minimum LoD in the following concentrations:

· 500u/mL: 20 IU/mL

· BK Virus (Human polyomavirus 1): must be FDA-approved OR in the process of receiving FDA approval. Vendor must be able to provide LoDs expected in a clinical setting, preferably meeting minimums in the following concentration:

· 500u/mL: 50 IU/mL

· Herpes Simplex Virus 1 / 2

· STI Panel, as a multiplex or “4-plex”

· Chlamydia

· Gonorrhea

· Trichomonas

· Mycobacterium genitalium

· Respiratory panel, as a multiplex or “4-plex”

· SARS-COV-2 (COVID)

· Influenza A

· Influenza B

· Respiratory Syncytial Virus (RSV)

· *LoD is defined as the lowest concentration that can be measured (detected) with statistical significance by means of a given analytical procedure.

The vendor must also be able to provide a qualitative, RT-PCR test for Human papilloma virus DNA in cervical specimens that meets the following criteria:

· Accepts all of the following liquid-based cytology media for cervical specimens:

· ThinPrep PreservCyt Solution

· SurePath Preservative Fluid

· Detects a minimum of 14 genotypes, to include:

· 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68

· Capable of resulting genotypes 16, 18, and 45 individually

· Must be clinically validated for primary screening and co-testing with cytology

· Minimum throughput of 300 samples in 8 hours Method Performance/Comparison shall be at the expense of the Vendor, shall include linearity material and reagents, and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:

1. Correlation studies for each analyte. A minimum of 20 samples, spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

2. Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines.

3. Precision study shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls.

4. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

5. Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood container are evaluated for interfering substances for each method performed.

6. Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols should be used:

a. If the suggested manufacturer's range is not appropriate for the patient population, a reference range must be established and may require additional reference individuals.

b. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test must be provided.

7. Analytical Measurement range validation studies must be performed by vendor for applicable analytes,

8. All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with each Laboratory's computer system, for local modification (editable) to meet CAP requirements.

9. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

10. Vendor must provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies).

11. Vendor must provide hands-on training to staff onsite prior to or during instrument integration at the facility. Expert/advanced user training should be offered at vendor/manufacturer site at a minimum of two (2) staff per instrument.

Analytical Systems:

a. Ability to manage testing workflow of hospital laboratory. Instruments must be able to perform testing for all described testing requirements simultaneously.

b. System must have a minimum of 2 assay processing units on board to minimize instrument downtime.

c. Analyzers must be capable of running short sample runs (smaller volumes) while also maintaining a minimum throughput of 300 samples per dayshift (8 hours).

d. Integrated modules must only require one system control center (computer and screen) to simplify operations.

e. Instruments must have load on the fly capabilities for reagents, samples, bulk solutions and consumables. Quantity of consumables and reagents must be monitored by the system software.

f. Reagents must be provided in combined packaging (“ready-to-use” cartridge or packaging) for ease of loading onto instrument. Reagent packs must be able to maintain appropriate storage temperature, and the system must offer continuous monitoring of this requirement (to include lot number, usage volume, and expiration date) to aid in inventory management.

g. Vendor instrument solution must provide a primary tube and aliquot sample loading capability to include automatic barcode reading.

h. Analyzers must either utilize disposable pipette tips OR demonstrate clinically insignificant carryover.

i. Analyzers must be able to perform “add-on” reflex testing on any previously run patient sample.

j. Vendor must have commonality across all analyzer platforms for the following:

a. Software

b. Reagents

c. Consumables

d. Methodology

k. Analyzers must feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups, probe crashes and unnecessary downtime.

l. Calibration of analyzer(s) must be easy and of minimal frequency. Calibrations must only be required when QC is out of range or new lot numbers of reagent are put into use. Calibrators should be liquid and ready to use with no reconstitution or prep required prior to use. List any calibrators that require preparation and the required process.

m. Analyzers must be capable of determining the quality of the sample, and be able to detect clots, low or insufficient volumes, aspiration issues such as bubbles, and other applicable liquid level sensing capabilities. Please describe how analyzer detects.

n. Quality control frequency not to exceed once/24 hours/instrument platform.

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

a. QC files may be edited or corrected for errors manually.

b. On-board quality control data storage and reporting capabilities.

c. Ability to view and print daily and monthly QC results.

d. Ability to view and print Levy Jennings graphs.

e. On-line documentation of out-of-range QC.

f. Read barcoded QC.

g. Westgard rules built in.

h. If QC fails, instrument will stop running samples.

p. Chosen analyzer(s) must have minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including washes and wait time, for daily, weekly, and monthly maintenance. Please include any hands on, automated non-maintenance activities.

q. Vendor to provide average number of service calls per year per analyzer, provide access to a 24/7 on-call support system, and perform preventive maintenance as required.

r. Analyzer must accommodate multiple tube sizes/vial sizes simultaneously.

s. Vendor must provide BTU output for both analytics and automation systems.

t. Meet space limitations. Selected design must maintain walkways and clearances around track and instruments.

u. LIS connectivity must be supported/available and should have approved use for Windows 10 or greater (more recent).

Reagents and Supplies:

1. Vendor must describe kit size options available for applicable tests.

2. Vendor reagents must be 99% liquid ready to use from storage, requiring no reconstitution or mixing. List all Reagents that are not liquid, ready to use.

3. Vendor calibrators must be at least 95% liquid ready to use from storage, requiring no reconstitution or mixing. List all assay calibrators that are not liquid, ready to use.

4. Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission. In the event that supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order.

5. Vendor must provide 5 years of FDA field action notifications.

TABLE 1. WORKLOAD DATA. All volumes are in tests per year.

VIRAL LOAD

TEST