SP_REQ-DASOBO-00042975_Approved.pdf

SP No. REQ-DASOBO-00042975 (Formerly SP-1148-19 and by inclusion SP-1051-18), Amendment No. 1_Final Page 1 of 6

REQUEST FOR SPECIAL PROCUREMENT (SP) No.

REQ-DASOBO-00042975 (Formerly SP-1148-19 & SP-1051-18), Amendment No. 1

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

1. Requesting Agency Name: The Department of Administrative Services, Procurement Services (DAS PS) on behalf of Oregon Health Authority (OHA)

2. Date of Request: August 3, 2023 3. Agency Number: 10700

4. Agency Contact Name: Jennifer Alton 5. Phone: (971) 375-5158

6. Type of Request: ___ Class Special Procurement _X_ Contract-specific Special Procurement

7. Amendment Time Period Requested: From: September 30, 2023 To: September 30, 2028

8. Total Estimated Cost for Amendment Time Period: $15,166,314

Note: Revised not-to-exceed (NTE) total: $29,431,878 (total incorporates $177,000 from SP-1051- 18)

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 (NBS) at Oregon State Public Health Laboratory (OSPHL), including continuation of Enhancements, Maintenance and Support for Revvity (previously known as PerkinElmer) Specimen Gate Software.

10. Amendment Request, Background, Current Need, and Proposed Contracting Procedure:

a. Amendment Request:

DAS PS, on behalf of OHA, requests approval of SP No. REQ-DASOBO-00042975 (Formerly SP- 1148-19 and by inclusion SP-1051-18), Amendment No. 1 to amend for the following:

1. Extend Contract No. DASPS-1527-18 (formerly Contract #OHA-140640) (Contract) with Revvity (PerkinElmer) for five (5) years through September 30, 2028; and

2. Add $15,166,314 in funding to cover the time extension; and

3. Update the Contractor’s name from PerkinElmer to Revvity.

b. Background:

The Oregon Health Authority is legally obligated by three Oregon Revised Statutes (ORS 433.285, ORS 433.290, and ORS 433.295) to conduct newborn bloodspot screening, which includes testing for four (4) lysosomal storage disorders, as mandated by Oregon Administrative Rule (OAR) 333- 024-0210. In 2012, OHA issued a Sole Source Notice for the procurement of equipment and test kits, leading to Contract No. OHA-140640-13 awarded to PerkinElmer Health Sciences, Inc. This contract encompasses the lease of tandem mass spectrometers (MS/MS) and the purchase of NBS test kits, along with Specimen Gate software.

SP No. REQ-DASOBO-00042975 (Formerly SP-1148-19 and by inclusion SP-1051-18), Amendment No. 1_Final Page 2 of 6

The Specimen Gate software has since been crucial in streamlining specimen tracking and result reporting for the Public Health Lab, which is required to perform these functions accurately and efficiently. Subsequent enhancements to the software have eliminated manual processes, reducing errors and reporting time. Additional tests were incorporated in 2018.

Contract No. DASPS-1527-18 involves FDA-cleared reagents and includes the lease, maintenance, and software (Specimen Gate) for tandem mass spectrometer instruments. These instruments, along with Revvity (PerkinElmer) reagent kits, are pivotal in analyzing dried bloodspots for over 40 inherited disorders.

OHA's NBS Services Program under the Oregon State Public Health Laboratory is tasked with identifying specific medical conditions in infants to prevent impairment. This program not only serves Oregon, but also has contracts with multiple entities, including other states and international hospitals. OHA serves customer’s encompassing hospitals and birthing centers in New Mexico, US Naval Hospitals in Guam, Okinawa, Yokosuka, Misawa AFB, and Yokota AFB, as well as Indian Health Service facilities like Chinle, Fort Defiance, and Shiprock. Furthermore, it includes Guam Memorial Hospital and Commonwealth Health Center in Saipan.

In 2019, SP-1148-19 extended Contract No. DASPS-1527-18 for continued reagent test-kit purchases, MS/MS equipment lease, and maintenance from Revvity (PerkinElmer). This extension is related to SP-1051-18, which focused on enhancing the Specimen Gate software and aligning it with the MS/MS lease.

The current Mass Spectrometer contract concludes on September 30, 2023.

“For additional historical and background information see Attachment 1, Original SP-1148-19 and Attachment 2, Original SP-1051-18.”

c. Current Need:

OHA initiated a solicitation request in July 2023. However, due to the instruments' connection to State servers, the project's nature shifted to encompass Information Technology (IT) aspects. OHA engaged DAS PS to ensure compliance with State statutes and rules. To ensure the uninterrupted provision of these services, DAS PS, on behalf of OHA, seeks an extension of the current contract with Revvity (PerkinElmer). This extension is intended to maintain services, while ongoing deliberations about future procurement avenues are underway. The requested extension, amounting to $15,166,314, encompasses the acquisition of reagent kits and consumables, instrument leasing, as well as support and maintenance for five (5) QSight instruments over a five-year period. The following table represents the total estimated costs for this SP amendment:

OHA MS/MS Instrument Lease, Software Support, and Maintenance Estimated Costs

Goods/Services: Year 1 Year 2 Year 3 Year 4 Year 5 MS/MS Instrument Lease and NeoBase 2 includes:

kits and solutions

$2,693,338 $2,828,005 $2,969,405 $3,117,876 $3,273,769

SP No. REQ-DASOBO-00042975 (Formerly SP-1148-19 and by inclusion SP-1051-18), Amendment No. 1_Final Page 3 of 6

Specimen Gate Software- Saturday Support

$44,784 $44,784 $44,784 $44,784 $44,784

Annual Support (SCID and LSD Assay Maintenance

$12,000 $12,000 $12,000 $12,000 $12,000

Estimated Total Cost: $15,166,314

d. Proposed Contracting Procedure:

1. As required by Oregon Administrative Rule (OAR) 125-247-0287, DAS PS will issue a public notice regarding approval of this SP Amendment No. 1 on the OregonBuys eProcurement system for a period of seven (7) calendar days.

2. The public notice will include provisions that any affected party may protest the approval of the SP Amendment Request.

3. DAS PS, working with OHA, will respond to and resolve all protests, if any.

4. If no protests to this approved SP Amendment No. 1 are received and sustained, DAS PS will proceed with amending the Contract as set out in Section 10.a above.

5. DAS PS and OHA will work with Enterprise Information Services (EIS) and obtain its endorsement prior to executing the Contract amendment, as required.

6. Pursuant to OAR 137-045-0015, DAS PS will work with Oregon Department of Justice (DOJ) and obtain legal sufficiency approval prior to executing the Contract amendment, as required.

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

This Special Procurement Amendment ensures uninterrupted NBS services, mandated by Oregon Revised Statutes, continue seamlessly while identifying an appropriate procurement approach. If an open, competitive procurement is mandated, a minimum of five (5) years would be needed for market research, needs assessment, Request for Proposals (RFP) development, contract negotiation, and potential transition to a new contractor. The current physical limitations of the NBS lab make simultaneous operation of two systems unfeasible.

Revvity (PerkinElmer) remains the exclusive provider of FDA cleared reagent kits for Northwest Regional NBS Program, validated on the existing MS/MS platforms. Deviating from this would incur substantial costs and require extensive re-validation, disrupting timely results for newborns with critical conditions.

The existing lease agreement offers flexibility in instrument numbers and free replacement, preserving continuity. Introducing new instruments would disrupt the NBS program, as it necessitates substantial information system and infrastructure changes.

This request aligns the equipment lease and reagent pricing with Specimen Gate software service period. Specimen Gate is essential for data processing in NBS. Without this contract, the State faces

SP No. REQ-DASOBO-00042975 (Formerly SP-1148-19 and by inclusion SP-1051-18), Amendment No. 1_Final Page 4 of 6 inability to process disorders, heightened error risk, delays, legal liability, and compromised reporting goals.

Potential consequences of not maintaining this contract include inability to process mandated testing, increased errors, delays, compromised reporting, inefficient processes, poor usability, manual data entry, and missing system functionalities. Maintaining this Special Procurement and contract with Revvity (PerkinElmer) is crucial for the NBS program's success.

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:

• In the case of Revvity (PerkinElmer)'s involvement, the original contract's basis was rooted in the fact that they were the only known manufacturer, vendor, and distributor of the required MS/MS instrumentation and kit reagents optimized for NBS dried bloodspot applications. The Oregon NBS Laboratory's possession of specific MS/MS instruments and exclusive use of reagent kits tailored for these instruments further underscores the unique technical compatibility that Revvity (PerkinElmer)'s offerings provide. This exclusivity is substantiated by the fact that the NeoBase AA/AC and SUAC test kits, integral to the screening process, are designed exclusively for use with PerkinElmer's MS/MS instrumentation and are not approved for alternate vendor equipment.

• Furthermore, the attachment of the Sole Source letter from Revvity (PerkinElmer) emphasizes their role as the sole provider of FDA cleared reagent kits specifically required for the screening of statutorily mandated disorders in the Northwest Regional NBS Program. This reinforces the necessity of their involvement for meeting regulatory standards and ensuring accurate screening.

• In essence, the decision to continue contracting with Revvity (PerkinElmer) is driven by the technical requirements and exclusivity associated with the services and equipment involved. The absence of comparable alternatives that can meet the same standards and regulatory requirements, as well as the transparent and well-documented process, contributes to mitigating any concerns of favoritism or competition diminishment in the awarding of public contracts. The focus remains on the specialized technical capabilities and regulatory compliance necessary for effective disease screening.

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:

SP No. REQ-DASOBO-00042975 (Formerly SP-1148-19 and by inclusion SP-1051-18), Amendment No. 1_Final Page 5 of 6

The proposed amendment to this special procurement agreement with Revvity (PerkinElmer) secures ongoing collaboration in the public interest. By leveraging Revvity (PerkinElmer)'s FDA cleared MS/MS test kits, we ensure reliable and timely NBS, crucial for accurate detection of metabolic disorders in infants. This early identification minimizes risks, reducing infant morbidity and mortality. The amendment's cost-effectiveness, prevention of disruptions, and improved health outcomes further emphasize our commitment to public welfare.

Moreover, the utilization of the Special Procurement process serves to advance the public interest in various ways. It guarantees the prompt and consistent implementation of testing methods, yielding reliable results. These outcomes, in turn, play a pivotal role in the ongoing initiatives aimed at reducing infant morbidity, mortality rates, and potential program liabilities.

Thus, the adoption of this approach not only ensures prudent financial management, but also aligns with the overarching goal of enhancing public health outcomes and minimizing associated risks.

13. Signature: The actual signature of the Agency Head or designee (e.g., Designated Procurement Officer) is not required on the Request submitted through OregonBuys. Agency may elect to attach a signed Request as a pdf file through OregonBuys or submit a signed hard copy Request.

Signature: e.g. Electronically in OregonBuys _________________ Name/Title: Date:

SP No. REQ-DASOBO-00042975 (Formerly SP-1148-19 and by inclusion SP-1051-18), Amendment No. 1_Final Page 6 of 6

PART B. The Department of Administrative Services completes Part B.

STATUTORY AND RULE AUTHORITY:

ORS 279B.085(2) states the Director of the Department of Administrative Services may approve a special procurement if the Director finds that a written request submitted under ORS 279B.085(4) demonstrates that the use of a special procurement as described in the request, or an alternative procedure prescribed by the Director will:

(a) Be unlikely to encourage favoritism in the awarding of public contracts or to substantially diminish competition for public contracts; and (b)(A) Result in substantial cost savings to the contracting agency or to the public; or

(B) Otherwise substantially promote the public interest in a manner that could not practicably be realized by complying with requirements that are applicable under ORS 279B.055, 279B.060, 279B.065 or 279B.070 or under any rules adopted thereunder.

OAR 125-246-0170 delegates the authority of the Director of the Department of Administrative Services to approve special procurements to the State Chief Procurement Officer. OAR 125-247-0285 through 125-247- 0288 implement ORS 279B.085.

OAR 125-247-0700(2) Protests and Judicial Review of Special Procurements designates the State Chief Procurement Officer as the Contract Review Authority.

FINDINGS: The findings are accepted, adopted, and incorporated by reference herein.

CONDITIONS OF APPROVAL:

1. Notice Period. The Authorized Agency shall post the Public Notice on OregonBuys. The Special

Procurement may not be used until after the completion of the seven (7) day notice period required pursuant to OAR 125-247-0287(4), and either:

a. No Written protests are received by the Contract Review Authority, State Chief Procurement Officer, from an Affected Person in response to the notice, or

b. If any protest is received during the notice period, then not until:

i. the State Chief Procurement Officer or delegate issues a written disposition of the protest in accordance with ORS 279B.400 and OAR 125-247-0700 and OAR 137-047-0700, and

ii. confirms in writing the first possible date of use of the Special Procurement.

2. ORS 279A.165 Requirements. Authorized Agency shall comply with the requirements of ORS 279A.165 and OAR 125-247-0287(12) regarding a report about this Special Procurement. Agency shall use a form and follow the instructions provided by the State Chief Procurement Officer or delegate.

3. Authorized Agency shall comply with all Enterprise Information Services (“EIS”) conditions and requirements prior to Contract execution (as required).

APPROVED:

Kelly Mix, State Chief Procurement Officer, Date:

Department of Administrative Services