Sources Sought Notice__ Cost Per Test for Immunoassay Testing.pdf

Immunoassay Testing

Sources Sought Notice – Cost-Per-Test- Immunoassay Testing:

Hepatitis Antibodies and Antigens, Anti-thyroglobulin, Anti-thyroid

Peroxidase and Tacrolimus Assays

The Regional Health Contracting Office - Central is issuing this Sources Sought Notice on behalf of San Antonio Military Medical Center, JBSA - Fort Sam Houston, Texas. Any responses to this Sources Sought Notice will be used for planning purposes only. This notice is not a solicitation of binding offers, nor is it a notice to proceed.

The San Antonio Military Medical Center (SAMMC) has a requirement for three types of immunoassay testing: Hepatitis Antibodies and Antigens assay, anti-thyroglobulin and anti-thyroid peroxidase assay and tacrolimus assay for FY22 through FY26.

The chemiluminescent micro particle immunoassay provides the quantitative determination of (1) hepatic virus’s antibodies and antigens, (2) antibodies to Thyroglobulin and Thyroid Peroxidase, (3) tacrolimus. The assay results of hepatic virus’s antibodies and antigens, in conjunction with other laboratory results and clinical information, are to aid in the diagnosis of acute, chronic, or resolved hepatitis. The thyroglobulin and thyroid peroxidase testing is to be used as an aid in the diagnosis of autoimmune thyroid disease. The tacrolimus testing is used as aid in management of liver and kidney allograft patients receiving tacrolimus therapy.

Vendors that consider themselves capable of providing the required testing are invited to submit a capability statement for the Government to consider via email to the Point of Contact listed herein. This capability statement shall include the following information. If the capability statement does not address ALL of the points below, the vendor will not be considered as capable of providing the required testing:

1. Vendor name (to include CAGE code and DUNS number); Point of Contact (to include email address and phone number); business size.

2. Documentation that demonstrates its ability to provide Hepatitis Antibodies and Antigens assay, anti-thyroglobulin and anti-thyroid peroxidase assay and tacrolimus assay (and quality control kits) testing.

3. Food and Drug Administration (FDA) approval if applicable.

Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Basic Requirements: The system must contain random access technologies that improve workflow. The system must be scalable on site to accommodate anticipated increases in workload and to acquire improved technology. The system must fit in the current space available which is approximately 7’9” x 5’0”.

Analytical Systems:

a. Ability to manage testing workflow of hospital laboratory. Analytical configuration of immunoassay platforms must provide for backup analyzer(s) with equivalent menus utilizing the same reagent formulation to ensure correlation with primary instrument and backup instrumentation.

b. Analyzers must have a minimum throughput of 200 tests per hour for Immunoassay per module.

c. Vendor solution must be scalable and able to connect multiple modules together to increase efficiency and reduce space requirements in the laboratory.

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.

f. Vendor instrument solution must provide a universal carrier capable of utilizing an array of different tube sizes in one carrier, thus avoiding the need for pre-analytic sorting into specific tubes and dedicated colored racks.

g. Analyzers must have clinically insignificant carryover and not require the use of disposable pipette tips or aliquots or specific aspiration order of assays.

h. Analyzers must be able to repeat and reflex test, auto-rerun and auto-dilute

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

a. Software

b. Reagents

c. Consumables

d. Methodology

j. Immunoassay technology which supports 1 step, 2 step or 2 step pretreatment assays which minimizes or eliminates heterophile antibody interferences, high dose hook effects, and other interferences assuring the highest result integrity

k. Each immunoassay analyzer must have a minimum of 47 reagent slots to allow for maximum load up of reagents to increase walkaway time and reduce technologist intervention.

l. Immunoassay STAT tests results must be available in <16 minutes from the time loaded on the analyzer to the time results are available. There must be the ability to designate stat lanes on the instrument and on the instrument spurs of the automation line so that all stats put on the line will be prioritized at the Input, Centrifuge and instruments.

m. Instruments must be available for full front loading of samples, reagents, consumables and bulk solutions on the fly and STATs must take priority over routine testing.

n. Analyzers must have flexible STAT testing options to prioritize the most critical samples based on workflow.

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

p. Instruments and automation must use point in space sampling to eliminate need for pipette tips and aliquots.

q. Calibration of immunoassay analyzers must be easy and of minimal frequency. Immunoassay 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.

r. Analyzers must be capable of monitoring reagent usage, maintaining and storing on board supplies/reagents for 24 hours of patient testing on the combined platform, and providing reagent inventory upon request, in real time.

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

t. 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 –

u. Chosen analyzers 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.

v. Vendor to provide average number of service calls per year per analyzer.

w. Analyzer must accommodate multiple tube sizes simultaneously.

x. Instrument must have liquid level sensing, clot, foam and bubble detection. Please describe how analyzer detects.

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

z. Meet space limitations of 7’9” x 5’0” (water system to be in separate location). Selected design must maintain walkways and clearances around track and instruments.

Reagents and Supplies:

1. Vendor must provide multiple test kits sizes for immunoassays, including over 500 tests per kit options for IA testing to handle highest volume testing

2. Immunoassay Instruments must perform accurate automatic dilutions on out- of- range results.

3. As indicated in the FDA safety alert communication, assays that use free capture streptavidin/biotin in their assay architecture have been demonstrated to show interference which can lead to misdiagnosis and medical error. We require that the immunoassays must not use free-capture streptavidin/biotin in the assay architecture to minimize the risk of interference from ingested biotin.

4. 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.

5. 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.

6. Vendor must provide Sigma data on chemistry testing verified by 3rd party source, using CLIA and CAP data.

7. 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 the 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.

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

Additional System Requirements:

1. Comprehensive on board QC Program, including Troubleshooting or System Validation QC material.

The system must have quality control data storage and reporting capabilities, the ability to view and print daily and monthly QC results, view and print Levy Jennings graphs, visually alert the operator of QC failures and to document out of range QC.

2. Upgraded Software/ Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

3. New Test Methods: Vendor/technical support specialist shall perform all validation studies including:

installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP/CLSI standards) and normal range studies at no initial charge.

Maintenance and Service Support Requirements:

1. Minimal Hands-on System Maintenance required, including limited reagent preparation time/steps prior to use. List reagent /calibrator prep for assays.

2. Computer Patient Data Handling: No hardware, containing any patient information is to be removed from any location, without the approval and removal of data by the facility information technology department.

3. Preventative and Predictive Maintenance: Contractor shall provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. Minimum of 1 per year per instrument unless documentation for volume performed denotes not required for optimum quality of operation.

4. Emergency Repair: Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. The contractor shall perform emergency repair service within 24 hours of time of notification of the malfunction.

5. Maintenance Support: Service repair person locally based within San Antonio geographical area,

6. Operator Procedure Manuals: Operator and Service manuals along with CLSI compliant procedures must be furnished for each instrument model supplied, unless provided electronically on board the instrument. Vendor to write Standard Operating Procedures for each assay in the laboratory template, to ensure that procedures are totally available prior to implementation.

Training and Technical Service Training:

1. The contractor shall include off-site (manufacturer facility) training for two operating personnel for each instrument installed and all automation system components at the time of installation of the contractor's equipment and each year thereafter that the contract remains in effect. User training is to include all costs of off-site training, i.e., transportation (air and ground), room and board.

2. On-site training by vendor shall also be supplied to all laboratory staff as needed.

3. Vendor shall provide/install/train users on the data management system with either off site or in house training. On-site refresher training in renewal option years of the contract shall also be made available annually.

4. In addition, the contractor shall provide supplemental operating training to above government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

5. The contractor, at his/her discretion, may make additional training available at his/her facility on terms and conditions mutually agreed upon by the agency and the contractor.

Installation and Initial Set Up:

1. SITE PREPARATION: Site preparation specifications shall be furnished in writing by the contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications.

2. SPACE REQUIREMENTS, SYSTEM SPECIFICATIONS ETC.: Configuration of the proposed equipment must be able to conform to the space previously allotted for this function. System specifications must all be disclosed in the proposed space. Crossover from current to new instrumentation must be performed timely with no interruption in patient care laboratory service. Installation must not require extensive renovations to allocated space at Department of Pathology and Area Laboratory Services, Brooke Army Medical Center.

3. OWNERSHIP OF EQUIPMENT: Ownership of the equipment shall remain with the contractor. All accessories (unused consumables, etc.) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzer within ten (10) calendar days.

4. GOVERNMENT's RESPONSIBILITY: The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user will maintain appropriate daily records to satisfy the requirements of this paragraph.

5. INSTALLATION PROCEDURES:

a. The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer.

Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

b. Vendor shall provide equipment installation and possible reinstallation at minimal costs if the equipment is required to be moved due to construction or laboratory redesign.

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. Proposal should include automated pre-analytical specimen processing for Tacrolimus; Anti- Hepatitis B Surface Antibody; Hepatitis B Surface Antigen; Anti-Hepatitis B Core Antibody, Total tests; Anti- Hepatitis B Core Immunoglobulin M; Anti-Hepatitis C Virus; Hepatitis A Immunoglobulin M; Hepatitis A Virus Immunoglobulin G; and Hepatitis B Surface Antigen Confirmatory. 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, lipoma, or other interrupting substances including blood and urine 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 to 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).

The response due date for this Sources Sought Notice is 4:00 PM CST, 7 April 2022. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs: