Single Source Procurement: New Born Screening - Immunoassay

Pursuant to New York State Finance Law § 163.10(b), The New York State Department of Health is presenting the following summary of relevant circumstances, and material and substantial reasons why a competitive procurement was not feasible.

The NYS Department of Health received approval of a Contract Reporter Exemption Request to establish a single source agreement with Perkin Elmer to purchase their test kits for use with existing proprietary apparatus. These kits were formerly procured from the OGS contract which have expired. The need and rationale for this agreement is discussed below.

The Newborn Screening Program is mandated to test all infants born in New York State. Public Health Law 2500(a-f) requires the Program to test and identify infants with serious but treatable neonatal conditions and to refer those infants for immediate medical intervention. Failure to complete testing protocols accurately and timely can result in catastrophic health consequences, including death for affected infants. The Program tests approximately 270,000 specimens from 240,000 New York infants for 48 congenital conditions each year, reporting over 12 million test results annually. A daily average of over 1,000 specimens must be tested, and results must be reported expeditiously; any delay or interruption in testing may have catastrophic consequences and such risk cannot be tolerated, especially in a newborn population.

Screening for hypothyroidism, Cystic fibrosis and Congenital Adrenal Hyperplasia is performed as per NYS Public Health Law mandates.

The Newborn Screening Lab must maintain its screening mandates to enable the performance of these critical newborn screening procedures. Maintaining the lab's high workload requires the continued purchase of the Perkin Elmer test kits for each of the specified assays which will continue to be run on the specialized instrumentation currently in place. The AutoDELFIA Plate Processor is an automatic immunoassay system widely used in newborn screening laboratories. The system runs from an external PC using intuitive and proprietary AutoDELFIA Workstation software. No other manufacturer's kits are compatible for use with these instruments.

The large majority of labs in the US use the Perkin Elmer AutoDELFIA. Therefore, based on current data, the NYS NBS program is using a method many view as the industry standard. If the program was to switch kits to another available kit, new instrumentation in excess of a million dollars would need to be purchased in order to run testing. A minimum of six months of running parallel assays (with current and new kits) would follow to ensure that the old and new kits were running similarly and to determine new cut-offs and algorithms. An extensive validation would be required to meet the Clinical Laboratory Evaluation Program (CLEP) requirements for assay validation. Reagent and consumable costs would double for approximately six months (an additional estimated $700,000 would be needed), and the additional staff time required would be costly. It is essential, but also cost-effective for the lab to continue utilizing the current testing methodologies.

Procurement / Program Name New Born Screening – Immunoassay
Contractor Name(s) Perkin Elmer
Contract Period One Time Delivery
Contract Number(s) WC2120