FAR 6.3_JOFOC Kathleen Fagan_Redacted.pdf

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United States Department of Agriculture Justification for Other than Full and Open Competition

Commercial Supplies/Services Exceeding $7.5 Million, and Non-Commercial Supplies/Services Exceeding the Simplified Acquisition Threshold

FAR 6.3

Control No.: Version No. One

Dated: 1 August 2022

1. Identification of the agency and the contracting activity.

United States Department of Agriculture’s Food Safety and Inspection Service

2. The nature and/or description of the action being approved.

The USDA’s Food Safety and Inspection Service proposes to enter into a contract on a basis other than full and open competition, and negotiate a sole source, firm fixed-price contract with Kathleen Marie Fagan, MD, MPH, FACOEM.

The contractor will assist FSIS in assessing the relationship between slaughter line speed in young chicken and swine slaughter establishments and the scope, magnitude, and factors that influence worker safety and health risks for establishment employees working on the slaughter line. This should include the impact of acute and cumulative work-related musculoskeletal disorders and antimicrobial-related respiratory diseases specifically related to slaughter line speed. The overall purpose of this consultation is to provide specialized knowledge and expertise in workplace safety and health, and to advise FSIS regarding the development and implementation of guidance and regulatory frameworks to identify collateral effects, including the risk of worker injuries and illnesses, related to slaughter line speeds.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

FSIS requires contracting support to design and conduct a study in the area of possible collateral health effects of increased poultry slaughter line speeds, including ergonomic hazards in the workplace, measurement of biomechanical risk factors for acute and cumulative work-related musculoskeletal disorders, epidemiology, and ergonomics research. The study will be used as neutral, expert neutral opinion for a pending litigation.

4. The statutory authority permitting other than full and open competition.

The following circumstance provides the justification for other than full and open competition under FAR 6.302-3(a)(2)(iii):

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“To acquire the services of an expert or neutral person for any current or anticipated litigation or dispute.”

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

Dr. Fagan is Board Certified in Occupational Medicine and practiced clinical occupational medicine in Cleveland, Ohio for 25 years. She received her BA in Sociology at Northwestern University in Evanston, IL and went on to receive her MD at Case Western Reserve University in Cleveland, OH in 1978. She completed her internship and residency at Cook County Hospital in Chicago, IL and her MPH at the University of Illinois, School of Public Health. She joined OSHA's Office of Occupational Medicine and Nursing in May of 2009.

Dr. Fagan currently does occupational and environmental health consultation work and teaching at Case Western Reserve University School of Medicine. She became an ACOEM fellow in 2020 and is vice-chair of ACOEM’s Environmental Health section.

Dr. Fagan has extensive experience summarizing the role of medical surveillance as protection and prevention. She has examined and cited examples of medical surveillance in a chicken processing plant with an in-plant medical care unit and the shortcomings revealed by OSHA inspections, including poor medical reporting, nurse logs and lack of patient care. Her findings concluded that imperative to progress in the field is educating in- plant medical caregivers on state and medical laws.

Dr. Fagan also cited an examples of audiology services advertising the ability to cut OSHA-recordable standard threshold shifts which results in poor diagnosis of hearing loss. She has emphasized the need for consistent surveillance to prevent errors.

Dr. Fagan has noted additional preventative measures are being identified by researchers in medical surveillance who are studying cases of workplace death that had no prior doctor’s visits, as well as how to make medical surveillance something that companies understand.

Her work in this field is greatly respected and her expertise is required by the Government.

6. Description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

FSIS has researched the qualifications of many Occupational Health professionals but not have identified any “willing” individuals to meet the Government’s requirements within the required timelines. If any additional professionals are identified, FSIS will conduct further market research to determine if they possess the skill necessary to meet the Government’s requirements.

7. Description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

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FSIS has reviewed the qualifications of many Occupational Health professionals and have identified a limited amount of professionals that were qualified to serve as natural, expert witness. FSIS has reviewed University Professionals, GSA Schdules, internal and external GWACs.

8. Any other facts supporting the use of other than full and open competition.

There are no additional facts supporting the use of other than full and open competition.

9. Listing of the sources, if any, that expressed a written interest in the acquisition.

Kathleen Marie Fagan, MD, MPH, FACOEM

10. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

There are no action(s)necessary to remove barriers to competition as the requirement is not reoccurring and the qualifications to meet this requirement in the future as based solely on the requests of the Court in the pending litigation.

11. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer will determine if the cost to the Government will be fair and reasonable by analyzing pricing information provided by the offeror in accordance with FAR 15.404.

Certifications & Approvals

☒ The information provided for this justification has been reviewed and certified accurate and complete by _ _ (Insert Name), Program/Technical Personnel.

Contracting Officer (not exceeding $750,000). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☒ Approved.

☐ Reviewed and forwarding to the Procuring Activity Advocate (MASCO or Delegate).

George D. Baptist III Contracting Officer