A13_SSJ.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

David J. Blackley

National Institute for Occupational Safety and Health Respiratory Health Division, Surveillance Branch 1000 Frederick Ln.

Morgantown, WV 26508

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Contracts Management Branch 2920 Brandywine Rd.

Atlanta, GA 30341

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: NIOSH seeks a state public health agency partner to conduct implementation activities for electronic case reporting (eCR) of malignant mesothelioma, asbestosis, and silicosis cases from healthcare organizations to the state health department. The findings of this assessment will inform NIOSH’s ongoing evaluation of the feasibility of a mesothelioma patient registry including recommendations for rapid case ascertainment methods. The contractor should have prior experience with eCR for reportable conditions, including connection to the appropriate informatics messaging platform(s) to support data transfer. The contractor will author reporting specifications for mesothelioma, asbestosis, and silicosis using the Reportable Conditions Knowledge Management System, develop a list of critical data elements, receive electronic reports on mesothelioma patients, analyze data received, describe future system requirements to support routine reporting of these cases, and report to NIOSH on key lessons learned from their experience. The contractor will also host a webinar and develop a written guide to support adoption of eCR by public health agencies for these conditions.

Rev. 5/14/19

b. Procurement Request (PR) Number (if available): 84264

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor:

Occupational Health Branch California Department of Public Health 850 Marina Bay Parkway, Building P, 3rd Floor Richmond, CA 94804

b. Estimated Procurement Amount: $81,700

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency

☐ Exclusive licensing agreements/Proprietary data

☐ Brand name required

☐ Industrial mobilization

☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency

☐ Only One Source

☐ Logical Follow Up

☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

California has the highest annual number of new mesothelioma cases in the nation. No other state has devoted similar personnel or resources to developing rapid case ascertainment methods for mesothelioma. Epidemiologists and occupational medicine physicians from the California Department of Public Health (CDPH) have made substantial contributions to NIOSH’s mesothelioma registry feasibility assessment through participation in a stakeholder workshop, authorship of a peer-reviewed paper describing recommendations from that workshop, and leading assessments of rapid case ascertainment for mesothelioma using electronic pathology reports and electronic case reporting (eCR). In addition to operating in a state with a high burden of mesothelioma and legislative requirements that foster expedited reporting for cancers, CDPH has specialized expertise and interorganizational relationships that uniquely qualify it to accomplish this project in a timely manner so that the findings can inform NIOSH’s broader feasibility study.

Proven rapid case ascertainment tools are needed for a future mesothelioma registry to connect patients with clinical trials in a timely manner. California is the first state to require using natural language processing software to evaluate the contents of cancer pathology reports to improve reporting of cases to cancer registries. However, some patients receive a presumptive clinical diagnosis of mesothelioma without undergoing biopsy, and these patients would not be identified if case finding for a future registry relied exclusively on pathology reports. eCR is the automated generation and transmission of case reports from healthcare organizations to public health departments for review and follow-up. California is actively supporting eCR for multiple health conditions and has the personnel and systems resources required to continue scaling up this capacity. Unlike other states with fewer resources and less specialized experience, developing reporting specifications for mesothelioma and implementing specifications for conditions including asbestosis and silicosis is feasible in California. Reporting from healthcare organizations treating mesothelioma, asbestosis, and silicosis patients could facilitate more comprehensive case ascertainment which would inform future approaches for a mesothelioma patient registry.

b. What other products/services were considered and why did they not meet the need?

Based on extensive interactions with a variety of stakeholders since 2018, NIOSH has determined it is highly unlikely that other contractors would have the unique expertise, relationships and state environment required to conduct this assessment in an effective and timely manner.

3. Program Office efforts to seek potential offerors:

NIOSH has been conducting the registry feasibility study since 2018, and through interactions with national stakeholders, it has determined that the contractor is uniquely qualified to provide this critical service in a timely manner.

D. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: David J. Blackley, Supervisory research epidemiologist

5/17/2024

X David J. Blackley

Supervisory research epidemiologist

Signed by: PIV Center/Institute/Office COR/Program Official Signature:

Certification Date: 2/2/2024

E. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Timothy Barnes

Contracting Officer Signature:

Certification Date: Click here to enter a date.