|Sole Source Only Justification:||The Illinois Department of Public Health (IDPH) Laboratory requires reagent kits, supplies, and equipment to perform testing on Illinois newborns for metabolic and genetic diseases, Cystic Fibrosis (CF), Congenital Hypothyroidism (CH), Congenital Adrenal Hyperplasia (CAH), Galactosemia (GAL) and Biotinidase Deficiency (BTD). Reagent kits, supplies, and equipment must be United States Food and Drug Administration (US FDA) cleared. Testing equipment must employ five Genetic Screening Processors (GSP) such that each GSP analyzer performs all of the (5) metabolic and genetic disease tests within the same instrument and is equipped with the following components: multiple specimen Plate Stackers for up to 25 microplates (96-well) per stacker with continuous loading, Temperature Controlled Storage for assay reagents, Heated internal Incubator with Plate Shakers, Automatic Wash and Waste handling, punchers, computer with Windows based software, operated by means of touch-screen, printer, and De-ionized (DI) Water system with cartridges and service to handle a minimum of 800 specimens per working day, plus up to 100 repeats and quality controls.|
To continue with state mandated testing, the Illinois Department of Public Health (IDPH), Newborn Screening Section/Laboratory needs to procure a US Food & Drug Administration (US FDA) cleared reagent test kits, supplies, and equipment from Perkin Elmer, Inc. by sole source for seven (7) genetic diseases; Cystic Fibrosis (CF) disease; Congenital Hypothyroidism (CH) disease; Congenital Adrenal Hyperplasia (CAH); Galactosemia (GAL) disease and Biotinidase Deficiency (BTD) disease. Supplies include; DELFIA Inducer reagent, GSP Wash Concentrate, Pipette Tips, GSP Test kit, and 96-well microplates. Because the method is US FDA cleared, the reagents, supplies and equipment must be provided as approved. Perkin Elmer, Inc. will provide testing instruments with workstations, and includes all repairs, parts-fittings, preventive maintenance (PM), hardware, software and software updates, travel, labor, broken and/or faulty equipment replacement, and deionizer water (DI) component.
This procurement is critical to the mission of the agency and to the best interests of the State. Testing is mandated by Illinois law (Public Act 099-0403, The Newborn Metabolic Screening Act) which requires that all Illinois newborns be tested within the first few days of life for these disease conditions.
Perkin Elmer, Inc. is the only vendor with an United States Food and Drug Administration (US FDA) cleared test method (reagents, supplies, and equipment) for newborn genetic disease screening for Cystic Fibrosis (CF), Congenital Hypothyroidism (CH), Congenital Adrenal Hyperplasia (CAH), Galactosemia (GAL) and Biotinidase Deficiency (BTD). Perkin Elmer, Inc. does not sell or distribute its equipment through third parties or train non-Perkin Elmer staff to install, maintain or troubleshoot its equipment and software. Perkin Elmer, Inc. is the only vendor that offers an automated, United States Food and Drug Administration (US FDA) cleared method for these tests.
Perkin Elmer, Inc. Genetic Screening Processor (GSP) is United States Food and Drug Administration (US FDA) cleared. The US FDA has reviewed the data for the method and determined that its performance is reliable and that its results are accurate. This protects patients (newborns) and the Laboratory.
The Genetic Screening Processor (GSP) method is automated for newborn metabolic conditions. The seven (7) GSP assays replace seven (7) manual methods and older methods using low throughput instruments.
Perkin Elmer, Inc. is the only vendor that is able to maintain the Genetic Screening Processor (GSP). Perkin Elmer, Inc. does not train other vendors to maintain the equipment or the software.
Previously, bids were invited for these tests (IFB). However, Perkin Elmer, Inc. is the only vendor providing an automated United States Food and Drug Administration (US FDA) cleared test for seven (7) metabolic and gentic newborn screening assays. The contract requires Genetic Screening Processor (GSP) autoanalyzers including all major and minor repairs, parts and fittings, troubleshooting, bi-annual preventive maintenance (PM), hardware and software updates, installations, travel, labor, and as necessary, total replacement of a non-working instrument. In addition, Perkin Elmer, Inc. provides multiple deionized (DI) water unit systems to ensure accurate results. The contract requires that the equipment be available to the Laboratory until all supplies and reagents are used. This provision ensures that testing will be uninterrupted if new methods become available in the future.
The Laboratory must integrate high production testing into its Laboratory Information Management System (LIMS) which is the database used to track specimens, tests and report results. Automation is required because the laboratory test 800 specimens per day for 45 tests; manual data entry would allow for errors. Any laboratory system purchased must be integrated into the Laboratory Information Management system. Although a new test method can be adopted, it must be planned well in advance such that the Laboratory can contract software development with the Laboratory database.
If a competitive bid process is required for test methods for Cystic Fibrosis (CF), Congenital Hypothyroidism (CH), Congenital Adrenal Hyperplasia (CAH), Galactosemia (GAL) and Biotinidase Deficiency (BTD) then there is the possibility that separate contracts for separate methods will be awarded. This will require that the Laboratory develop validation studies comparing each method's performance with the current Genetic Screening Processor (GSP) method. The process will require many weeks for tens of thousands of samples to compare the methods statistically. This is because the newborn screening diseases are rare diseases that occur only one in 10,000 or fewer times for infants. Returning to separate methods will also require reassigning staff from other testing to newborn screening. Overtime will be required to ensure that the validation of the methods is done as quickly as possible to minimize the interruption of testing when the GSP equipment is removed from the laboratory.
The Perkin Elmer, Inc. Genetic Screening Processor (GSP) has been evaluated and used in the Illinois Department of Public Health Laboratory for newborn screening. The performance of the equipment and method have proven reliable and cost effective compared to the separate test methods used previously. At this time there is only one vendor offering an US FDA cleared automated method. The vendor, Perkin Elmer, Inc. has proven responsive to questions and requests for training and repairs.
The estimated cost of $1.865 million is offset by the supplies and equipment needs of the previous seven tests for five conditions. Two conditions (Galactosemia and Congenital Adrenal Hyperplasia) require two tests to ensure a positive result. Seven tests times 180,000 specimens per year, with even the small amount per specimen of $3 in supplies and equipment usage, is approximately $3.8 million per year. The GSP has been a good move for the Laboratory in terms of consolidating testing and minimizing the expense involved with the large Illinois newborn screening operation.