SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR), Occupational Health Unit (OHU) in order to determine if there are existing small business sources capable of providing a Physician Services and medical surveillance of Jefferson Laboratories’ Federal and Contract personnel.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 621111 – Offices of Physicians (except Mental Health Specialists); with a Small Business Size Standard of $16 Million, and you believe that your firm would be able to provide the FDA with the service described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background and Objective: The Jefferson Laboratories is committed to providing a safe and healthy work environment for all employees. It is recognized that research and support activities frequently require the use of research animals and chemicals which may have potentially hazardous properties.

An important element of employee safety is the Occupational Health Program which provides routine medical surveillance for all employees who are exposed to animals or hazardous agents. In addition, all personnel who enter certain animal areas are required to have specific health documentation annually.

The physician performs the role of Professional Supervisor of the hearing conservation program as per the Council for Accreditation in Occupation Hearing Conservation. The physician provides Medical Oversight for Public Access Defibrillator/AED program and Immunization program as provided by the Guidelines for Public Access Defibrillation Programs in Federal Facilities, and clinical expertise to the management and administration of the occupational health program and Occupational Health Unit (OHU) at the FDA Jefferson Laboratories campus. The program/OHU serves approximately 700 employees (NCTR, Office of Operations, and ORA government employees, and mailto:suzanne.martella@fda.hhs.gov permanent on-site contractors) and the primary responsibilities of this position include: interpreting clinical program requirements; formulating policies, methods, and procedures; and monitoring, reviewing, evaluating, and assessing the integrity and quality of clinical aspects of NCTR’s occupational health and safety program.

The Contractor (physician) is responsible for providing weekly clinics and telephone consultations for employee physical examinations, periodic health appraisals (PHAs), electrocardiogram and pulmonary functions tests (PFTs), vision and hearing testing, and review of blood/urine specimens. The physician is a vital member of the Occupational Health and Safety Program on campus providing oversight in the areas of respiratory protection and blood borne pathogens/universal precautions and oversees a medical surveillance program.

To meet the needs of the OHU, the contract physician will be needed on site for approximately five hours, one set day per week and available as needed for telephone and electronic consultation.

Typically, the Clinic is held on Wednesday from 8am until 1pm however the government reserves the right to change the clinic day and time. There are approximately forty-eight (48) clinics per year. The physician should have experience treating individuals working with highly toxic material exposure.

The physician must also have sufficient expertise to be considered a Subject-Matter Expert (SME) on Cercopithecine Herpesvirus 1 (Herpes B Virus). The physician must be available for consultation with the nurse treating workers to provide guidance regarding the possibility of Herpes B Virus infection.

All Non-Human Primate (NHP) workers at the JLC carry an information card as recommended by the National B Virus Working Group. This card contains contact information for the local subject-matter expert so the SME can consult with OHU staff or the workers’ personal physician. In this role, the physician must be available at all times for consultation with private physicians treating workers to provide guidance regarding the possibility of Herpes B Virus infection. It is also desired that the physician has occupational health experience and knowledgeable in such areas as what triggers a reportable OSHA action, repetitive motion injuries and ergonomic interventions. The Physician shall perform the following onsite occupational health services but not limited to the following:

Minimum Performance Requirements:

1. New Employee health evaluations and immunizations.

2. Treatment of employees with work related illness or injury during weekly clinic.

3. Medical surveillance examinations for employees who work with toxic or hazard materials.

4. Annual Qualifying/Nonqualifying physical exams for employees of select contracts.

5. Ability-to-work evaluation for personal or work-related illness or injuries.

6. Preventive medicine services, including evaluation of lab results, education and counseling.

7. Physician shall be available for consultation via telephone or email with the Occupational Health nurse during normal working hours at the JLC. This could include review of questionable EKG results, discussion of injury/illness symptoms, review of abnormal lab results, and need to refer for further diagnostic workup. Telephone or electronic consultations average about 3 per week with total time involved approximately 5-30 minutes per week. A physician shall return the call/email within 5 minutes 95% of the time and within 15 minutes of the remaining 5% call/email placement.

8. Epidemiological evaluation of data for workplace injury, illness prevention, and outcome analysis.

9. Medical clearance for employees performing job duties requiring respirator use.

10. Perform role of Professional Supervisor of the hearing conservation program as per the Council for Accreditation in Occupation Hearing Conservation, http://www.caohc.org/professional_supervisor/scope_of_practice.php including but not limited to interpretation of audiograms, diagnosis of hearing disorders, and determination of work-relatedness of hearing loss. She or he has the responsibility to establish policies for the audiometric testing program and supervise the audiometric testing activities conducted by the OHC, review problem audiograms, determine work-relatedness of an employee’s hearing loss, recommend follow-up procedures, and manage the audiometric database.

11. Provide Medical Oversight for Public Access Defibrillator/AED program and Immunization program as provided by the Guidelines for Public Access Defibrillation Programs in Federal Facilities and can be found at: http://foh.hhs.gov/services/aed/FMR_Bulletin_09-B2- Guidelines_Public_Access_Defib_in_Federal_Facilities.pdf. The physician shall approve all immunizations in the program as well as review the population the immunizations apply to. The physician determines if immunizations are appropriate and safe when not part of the Advisory Committee on Immunization Practices (ACIP) adult immunization program, especially if needed for Occupational risk rather than part of the adult immunization schedule.

Government Furnished Items The Government shall furnish any necessary supplies. The Government shall also furnish space within the Occupational Health Unit for the Physician to work on-site.

Contract Deliverables:

The Physician shall perform all the above-listed duties and any other assigned duties that are directly related to the position.

Contractor shall, monthly, within 10 business days following the end of each month, submit to COR and Contract Specialist (CS), monthly reports detailing the notable accomplishments/work performed during the previous month (weekly clinics provided, telephone consultations for employee physical examinations, PHAs, electrocardiogram and PFTs, vision and hearing testing, review of blood/urine specimens, other) and planned work for the current month. The report shall contain hours expended for the month and cumulative to date.

Period(s) of Performance: Anticipated to be a Base plus four (4) Option Years with the following period of performance dates:

Base Year: 09/16/2024 – 09/15/2025 Option Year 1: 09/16/2025 – 09/15/2026 http://www.caohc.org/professional_supervisor/scope_of_practice.php http://foh.hhs.gov/services/aed/FMR_Bulletin_09-B2-Guidelines_Public_Access_Defib_in_Federal_Facilities.pdf http://foh.hhs.gov/services/aed/FMR_Bulletin_09-B2-Guidelines_Public_Access_Defib_in_Federal_Facilities.pdf

Option Year 2: 09/16/2026 – 09/15/2027 Option Year 3: 09/16/2027 – 09/15/2028 Option Year 4: 09/16/2028 – 09/15/2029

Place of Performance

The Contractor shall perform its services on campus at NCTR. The Contractor will be provided with sufficient, suitable space where they can meet with patients to collect samples for the various lab services they are tasked to perform. Such services will take place at:

US FDA/NCTR

3900 NCTR Rd.

Occupational Health Unit, Building 54 Jefferson, AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in providing the same or substantially similar Physician Services. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, Unique Entity ID (SAM) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the performance and experience requirements identified above. The offeror should include resumes of potential on-site physicians with the necessary experience. Provide information how the offeror plans to meet the on-site clinic and telephone/electronic consultation requirement. Respondents shall limit their capability statements to no more than ten (10) pages, excluding cover page, table of contents and resume.

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience information for the same or substantially similar Physician Services. For each past performance reference include the date of service, description of service provided, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

5. If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

6. If a large business, provide whether subcontracting opportunities exist for small business concerns.

7. Though this is not a request for quote, informational pricing would be helpful for market research purposes.

The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 09:30am (Central Time in Jefferson AR) on May 14, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN123493.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.

mailto:suzanne.martella@fda.hhs.gov