SP-1148-19.pdf

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REQUEST FOR SPECIAL PROCUREMENT No. 1148-19

PART A. Requesting Agency must complete Items 1 through 13.

1. Requesting Agency Name: Department of Administrative Services (DAS PS) on behalf of Oregon Health

Authority, Public Health Division (OHA)

2. Date of Request: August 13, 2019 3. Agency Number: 10700

4. Agency Contact Name: John Anglemier 5. Phone: (503) 378-4650

6. Type of Request: Class Special Procurement X Contract-Specific Special Procurement

7. Time Period Requested: From: October 1, 2019 To: September 30, 2023

8. Total Estimated Cost: $14,088,564

9. Title: Supplies and/or Services to be Acquired: Reagent price agreement and tandem mass spectrometer instruments (MS/MS) equipment lease for the Northwest Regional Newborn Screening Program at Oregon State Public Health Laboratory (OSPHL).

10. Request, Background and Proposed Contracting Procedure:

a. Request:

DAS PS, on behalf of OHA, requests approval of this Special Procurement #SP-1148-19 to amend Contract No. DASPS-1527-18 (formerly Contract #OHA-140640) for an extension from October 1, 2019 through September 30, 2023, allowing for the continued purchase of NeoBase Reagent test-kits, SUAC reagent test-kits and the lease of MS/MS equipment, including maintenance and support from PerkinElmer Health Sciences, Inc.

This SP request is directly related to Special Procurement #SP-1051-18, approved last year for the direct award for enhancements of the Specimen Gate software, which is also provided by PerkinElmer Health Sciences, Inc. This effort is to align the Specimen Gate software and support with the lease of the MS/MS equipment.

b. Background:

OHA is required by three (3) statutes, ORS 433.285, ORS 433.290, and ORS 433.295, to provide newborn bloodspot screening. OHA is also responsible for testing and reporting on four (4) lysosomal storage disorders, which are mandated by OAR 333-024-0210.

In October of 2012, a Sole Source Notice #OHA-3505-12 was posted to the Oregon Procurement Information Network (ORPIN) by OHA for seven (7) days and received no protests. On March 12, 2013, Contract No. OHA-140640-13 was awarded to PerkinElmer Health Sciences, Inc. Contract No.

OHA-140640-13 is for the lease of the tandem mass spectrometers (MS/MS) and the purchase of

SP-1148-19 Page 2 of 6 newborn screening test kits to be used on the MS/MS equipment. The Specimen Gate software was included in Contract No. OHA-140640-13 at no additional cost.

OHA continues to use the Specimen Gate software to date. The Public Health Lab is required to track specimens and report results efficiently and with minimum risk of errors. Four (4) additional tests were added October 1, 2018. The recent Specimen Gate software enhancements have eliminated the need for manual processes, reduced risks and errors, and have decreased reporting time.

Contract No. DASPS-1527-18 is for Food and Drug Administration (FDA) cleared reagents (NeoBase and SUAC kits) and includes the lease and maintenance of tandem mass spectrometer instruments (MS/MS) and the Specimen Gate software required to interpret the instrument results with the reagent kits. These instruments are used with the PerkinElmer reagent kits to analyze dried bloodspots to detect a variety of amino acid and acylcarnitine analytes related to over 40 inherited disorders.

Through a regional program, the Oregon State Public Health Laboratory, Newborn Screening Program, has contracts for testing services with Alaska, Hawaii, Idaho, Nevada and New Mexico.

PerkinElmer instruments and software form the core of the testing infrastructure in the Newborn Screening (NBS) program. Removing or replacing a single element of this system would be highly disruptive to the testing workflow, which depends on streamlined integration between multiple instruments and the Specimen Gate software system.

Current Need:

OHA has a statutory requirement to maintain newborn bloodspot screening. The total estimated cost for the amendment period requested for these services and supplies will be:

Type:

10/1/2019 through

9/30/2020

10/1/2020 through

9/30/2021

10/1/2021 through

9/30/2022

10/1/2022 through

9/30/2023 Equipment Lease Fees (including Maintenance & Support) $203,861 $163,844 $166,760 $173,821 Reagent Kits & Supplies $3,368,160 $3,468,672 $3,572,352 $3,679,380 Total Cost: $14,088,564

c. Proposed Contracting Procedure:

• DAS PS will issue a public notice on the Oregon Procurement Information Network (ORPIN) as required by OAR 125-248-0287, regarding approval of this Special Procurement (SP) 1148-19 that includes a process by which an affected person may protest.

• At the completion of the seven (7) day notice period, if no protests to the SP are received and sustained, DAS PS, on behalf of OHA, will negotiate an amendment and extension to the Contract No.

DASPS-1527-18 with PerkinElmer Health Sciences, Inc.

11. Justification for use of Special Procurement: Describe the circumstances that justify the use of a

Special Procurement. Attach relevant documentation.

• PerkinElmer remains the sole provider of FDA cleared reagent kits used for the screening of statutorily mandated disorders as part of the Northwest Regional newborn Screening Program. The PerkinElmer

SP-1148-19 Page 3 of 6 reagent kits were validated on the current MS/MS platforms. Failure to use the vendor provided equipment would require purchase rather than lease as well as extensive re-validation for both the new instruments and for the software used. This would be prohibitively expensive and disrupt the laboratory’s ability to turn out timely results for newborns with potentially life-threatening conditions.

• Purchasing replacement MS/MS instruments would be extremely expensive and would not provide the level of service OSPHL is currently receiving from PerkinElmer, regarding equipment upgrades, repairs, and integration. Not only would the instruments need to be purchased, but they would have to be validated with the kits currently in use, the equipment interfaces would have to be updated, and additional maintenance would have to be purchased to meet regulatory requirements. All of this would require significant time and expense and require additional work to meet regulatory requirements. In addition, software changes were recently made to allow interfacing between the Specimen Gate software and those expenditures would have to be duplicated if the platform changed.

Further, the existing lease agreement provides significant flexibility to the state by allowing it to change the number of instruments leased (due to any changes in testing volume) without penalty and allows the replacement of equipment that fails at no extra charge.

• Replacing the MS/MS instruments would cause unacceptable disruption to the newborn screening program. The instruments cannot be replaced with other units without significant changes to the existing information system and infrastructure. Such changes would halt or delay screening in the NBS program, putting patients at risk. Newborn bloodspot screening is governed in Oregon by three

(3) statutes: ORS 433.285, ORS 433.290, and ORS 433.295.

• This request will align the term of the equipment lease and reagent pricing with the service period for the associated Specimen Gate software. Amendment No. 3 to Contract #OHA-140640 interfaced several instruments to the Specimen Gate software system which is integral to the operation of existing MS/MS instruments. Amendment No. 3 allows for support services through September 30, 2023, but did not alter the end date of the underlying contract. Specimen Gate software is used for the storage, retrieval, and processing of data generated in the newborn screening process.

• This Special Procurement and contract with PerkinsElmer is necessary for OHA to maintain the capabilities of the Specimen Gate software. Without a contract, OHA will be unable to satisfactorily conduct the newborn screenings and potentially cause the following:

o Inability to process and report on four lysosomal storage disorders when testing is mandated by state administrative rule OAR 333-024-0210.

o Increased risk of errors, delays in timeliness of reporting, additional work for staff, and potential legal liability to the State if a disorder is not detected and reported within the timeframe set by the U.S. Government Accountability Office (GAO) and U.S. Department of Health and Human Services (HHS).

o Frequent delays causing rework, untimely client servicing, and cumbersome processes for meeting federal and state reporting goals.

o Compromised ability to generate work lists (plate maps) for CPTlA, CF genotyping, and lysosomal storage disorders testing.

o Compromised ability to generate a file with test data and test results that can be accessed by Neometrics, a companion newborn screening laboratory information system.

o Inefficient manual and paper processes.

o Poor usability of existing tools, resulting in manual data entry, reporting and analysis issues.

o Manual workaround due to missing system functionalities.

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12. Findings to Satisfy the Required Standards: This proposed special procurement:

___X___ (a) will be unlikely to encourage favoritism in the awarding of public contracts or to substantially diminish competition for public contracts because:

• At the time of the original contract, PerkinElmer was the only known manufacturer, vendor and distributor of a complete package of MS/MS instrumentation and kit reagents that are optimized for use in newborn screening dried bloodspot applications.

• The Oregon Newborn Screening Laboratory currently has five (5) Waters Quattro Micro MS/MS instruments and uses reagents kits specifically designed and purchased for use with the instruments.

• The NeoBase AA/AC and SUAC test kits are optimized for use with the PerkinElmer MS/MS instrumentation and are not approved or available for use on alternate vendor equipment.

• PerkinElmer remains the sole provider of FDA cleared reagent kits used for the screening of statutorily mandated disorders as part of the Northwest Regional Newborn Screening Program. Sole Source statement from PerkinElmer is attached as Attachment A.

and

______ (b)(i) will result in substantial cost savings to the contracting agency or to the public because:

or

___X___ (b)(ii) will otherwise substantially promote the public interest in a manner that could not practicably be realized by complying with the requirements of ORS 279B.055, 279B.060, 279B.065, or 279B.070, or any rules adopted thereunder because:

• As Perkin Elmer is the only supplier of FDA cleared MS/MS test kits for newborn screening, any alternative to this agreement with would require the development of in-house reagents for statutorily mandated testing of newborn bloodspot specimens. OSPHL does not have the ability to manage this task. Failing to extend this agreement would cause unacceptable disruption to newborn bloodspot screening in Oregon, Idaho, Hawaii, and New Mexico.

• Use of another sourcing method to procure the MS/MS equipment set would likely result in the same outcome and incur the agency and vending community unnecessary costs in the process.

• In 2002, the Newborn Screening Laboratory began using PerkinElmer MS/MS reagents and instrumentation to detect amino acid and acylcarnitine makers for metabolic disorders. Of the known vendors at that time, PerkinElmer was the sole vendor offering an automated method requiring minimal personnel time, the ability to simultaneously run multiple analytes on the same instrument, high-throughput instrumentation to handle the volume of specimens received daily by the Laboratory, and reagent kits designed and optimized for use with the instrumentation.

• This special procurement has the ability to promote the public interest by way of timely and consistent testing methods and results that will assist the efforts in reducing infant morbidity, mortality, and program liability. There will be a cost savings to the Agency and the State by continuing to utilize the

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PerkinElmer equipment that is already in the labs and is matched with the Specimen Gate software that was enhanced last year through SP-1051-18 and Amendment No. 4.

13. Signature: The actual signature of the Agency Head or designee (e.g., Designated Procurement Officer) is not required on the Request if it is submitted through ORPIN. Agency may elect to attach a signed Request.

Signature: e.g. Electronically in ORPIN _________________ Type Name Date: