75N94025Q00025.RFI.PECRB Support Services.12.5.2024.pdf

Request for Information# 75N94025Q00025 PECRB Support Services

REQUEST FOR INFORMATION (RFI)

Title: Acquisition of Freezer and Bio-sample Support Services for the Phoenix Epidemiology & Clinical Research Branch (PECRB)

Description:

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support basic and clinical biomedical research and research training. The NIDDK is Congressionally mandated “to facilitate and enhance knowledge and understanding of diabetes, digestive diseases, kidney and urologic diseases, and nutritional disorders, including obesity on the part of health professionals, subjects, and the public through the effective dissemination of information.”

The Phoenix Epidemiology & Clinical Research Branch (PECRB), within the NIDDK Intramural Research Program, has a mission focused to determine the etiology of type 2 diabetes mellitus and obesity. The Branch is unique because it brings together scientists from diverse backgrounds to collaborate and applies the latest techniques in each discipline to solve a single problem. Using this approach, the Branch has made substantial progress in identifying the physiologic and genetic determinants of diabetes and its risk factors. In addition, researchers in the Branch have conducted several clinical trials to intervene in the natural history of this disease and to prevent the development of diabetes and its resulting severe complications. The goal of this research is to identify the causes of obesity and type 2 diabetes in humans for the purposes of improved prevention and treatment.

Objective:

The objective of this Request for Information (RFI) is to gather information on the capabilities of existing organizations to provide station support for administrative, infrastructure and logistical services to support Phoenix Epidemiology & Clinical Research Branch (PECRB).

Solution Overview:

The NIDDK envisions that a potential contractor would perform the following tasks:

TASK 1: Outpatient Clinic Support Services

The Contractor shall provide infrastructure, logistics, and administrative services in support of NIH PECRB. Support shall include assessable outpatient clinic space and staffing to support PECRB personnel in conducting human subject research under IRB-approved clinical protocols. The Contractor shall:

1.1 Provide infrastructure, logistics and administrative support to conduct outpatient visits for routine clinical assessments, sample collections, and health monitoring. The Contractor shall:

a. Receptionist shall perform administrative duties such as making copies, faxing and printing

b. Provide subject intake support including documenting weight, vital signs, and phlebotomy services

c. Support paper and electronic records storage

d. Provide support to federal staff in conducting exams and services and logistics for subject exams, including medical consultation and routine medical assessments, including subject examination table, sphygmomanometer, thermometer, otoscope/opthalmoscope, and stocked with appropriate supplies for subject examination (i.e.: gloves, tongue depressors, gauze, etc.), phlebotomy, and private biospecimen collection and disposal (such as urine samples, stool samples)

e. Provided services shall adhere to current Americans with Disabilities Act (ADA) compliance

f. Provide services and logistics for subject consultation

g. Provide temporary storage, including refrigeration and processing of samples

h. Provide maintenance and calibration of clinic examination tables, otoscopes, opthalmoscopes and scales – Not to exceed 40 occurrences per contract period

i. Provide body composition services (i.e.: Resting energy expenditure measurements), not to exceed 20 occurrences per contract period

j. Provide dexa scans, not to exceed 20 scans per contract period

k. Provide specimen processing, temp storage, transport for laboratory assessment, Not to exceed 250 occurrences per contract period

l. Provide emergency medical services (I.e.: defibrillator, medical oxygen), up to 2 occurrences per contract period

m. Provide ultrasounds and ultrasound services, not to exceed 10 per contract period

n. Provide medical personal protective equipment (i.e.: gloves, masks, face shields, hand sanitizer), cost not to exceed $10,000 per contract period

o. Optional task - Provide additional medical personal protective equipment (i.e.: gloves, masks, face shields, hand sanitizer)

p. Optional task - Provide additional maintenance and calibration of clinic examination tables, otoscopes, opthalmoscopes and scales – Not to exceed 20 occurrences per contract period

q. Optional task - Provide additional body composition services (i.e.: Resting energy expenditure measurements), not to exceed 10 occurrences per contract period

r. Optional task – Provide additional dexa scans, not to exceed 10 scans per contract period

s. Optional task - Provide additional specimen processing, temp storage, transport for laboratory assessment, Not to exceed 125 occurrences per contract period

t. Optional task - Provide additional emergency medical services (I.e.: defibrillator, medical oxygen), up to 2 occurrences per contract period

u. Optional task - Provide additional ultrasounds and ultrasound services, not to exceed 10 per contract period

1.2 Process PECRB employees, trainees, and subjects, who will be supporting or visiting the out-patient clinic, to provide access control for up to 50 individuals, including issuance of any required ID badge, access controls, and parking tag (if needed)

1.3 Provide on-site licensed pharmacist and services, including cataloguing, storage, dispensing, etc of labelled tracers, non-narcotic drugs, crash cart meds, etc.

a. Optional task - Provide on-site licensed pharmacist and services, including cataloguing, storage, dispensing, etc of labelled tracers, non-narcotic drugs, crash cart meds, etc.

1.4 Provide an automated medication service for dispensing system that supports medication management, dispensing, and tracking (i.e.: Pyxis, Omnicell, or equivalent)

1.5 Provide certified medical bioengineer to check, validate, and maintain required certification of medical equipment used in used in the outpatient clinical space (i.e.: otoscopes, blood pressure assessment tools, examination tables, scales, etc) along with clinical research equipment (i.e.:

Dexa scanner, Fibroscan, electrocardiography machine, etc)

1.6 Maintain the proper Certificate of Use or Occupancy issued for the clinic space

1.7 Operating services including utilities, phone, internet access, and access to automated external defibrillator(s) and medical oxygen (emergency equipment)

TASK 2: Information Technology Services

In order to support PECRB Outpatient Clinic Services the area that supports the outpatient clinic must be part of NIDDK network, so access is available for CRIS (EHR system) and REDCap (protocol tracking system).

IT requirements include:

2.1 Secure wireless network connectivity for PECRB employees and patients to use while utilizing outpatient clinic support and metabolic kitchen services defined in Task 1 and Task 3, to connect to NIH VPN to access NIH CRIS EHR system.

2.2 Notification of service, maintenance, and outages. The Contractor shall notify the COR and CO of service outages for any reason. From the time of receipt of the notification, the Contractor shall respond within the time limits as indicated below to discuss the outage reason/issue. If it is determined by the Contractor that the outage restoration time frames cannot be met, the Contractor will contact the COR. The Contractor shall respond to the Government within one (1) hour of notification.

a. Emergency Outage. The COR will consider any outage affecting the biorepository as an emergency outage if an outage significantly affects the mission of the Government installation.

The Contractor shall work with relevant POCs to restore service within two (2) hours from the time the Contractor responds to the Government's notification

b. Catastrophic Outage. Restore service within six (6) hours from the time the Contractor responds to the Government's notification

c. Serious Outage. Restore service within twelve (12) hours from the time the Contractor responds to the Government's notification

d. Routine Outage. Restore service within one (1) calendar days from the time the Contractor responds to the Government's notification

e. Scheduled/Planned Outage. The Contractor shall provide the Government with written notice at least five (5) business days prior to any scheduled or planned outages

f. Protected Circuit. The Contractor shall provide a protected circuit that will remain operable in the event of an unplanned outage

TASK 3: Metabolic Kitchen

Contractor shall provide metabolic kitchen services and provide PECRB staff access to kitchen facilities for the preparation and packaging of carefully controlled meals and snacks for human subjects enrolled in metabolic research studies. Service shall meet all food safety requirements and adhere to good medical practice for a clinical research setting, including:

3.1 Having standard operating procedures (SOPs) for all aspects of operations with appropriate staff training to execute tasks with high quality and efficiency.

3.2 Periodic calibration and reporting of equipment, such as scales, refrigerators, and freezers, to ensure accurate temperatures and measurements.

TASK 4: Government Furnished Equipment (GFE) / Government Furnished Information (GFI)

The Contractor shall maintain a detailed inventory accounting system for GFE and GFI. The inventory accounting system must specify, at a minimum: product description (make, model), Government tag number, date of receipt, name of recipient, location of receipt, current location, purchase, and contract/order number under which the equipment is being used. The Contractor shall either: a) attach an update inventory report to each monthly report, or b) certify that the inventory has been updated and is available for Government review. In either case the Contractor’s inventory listing must be available for Government review within one business day of COR or CO request.

Background:

This requirement has been in place for the previous ~35 years and has been accomplished in year-to-year agreements in partnership with the Phoenix Indian Medical Center campus that is owned and operated by the Indian Health Service (IHS). NIDDK funded IHS Full Time Employees (FTEs), and NIH FTEs/contractors/trainees funded by NIDDK, were used to support these efforts through an Interagency Agreement (IAA) and associated Memorandum of Understanding (MOU).

The most recent IAA was NIDDK#: A-DK12005; Period of Performance (PoP) 10/1/21 - 9/30/22:

Subsequent IAA modifications including NIDDK#s: A-DK12005-002-00001 and A-DK12005- 002-00002 added funding to the original agreement.

Past support has focused on additional areas of support including:

• Outpatient Clinic Support Services: Infrastructure, logistics, and administrative services in support of NIH PECRB. Support has included assessing outpatient clinic space and staffing to support PECRB personnel in conducting human subject research under IRB-approved clinical protocols

• Information Technology Services: PECRB Outpatient Clinic Services are part of the

NIDDK network to allow access to CRIS (Electronic Health Record System (her) system) and REDCap (protocol tracking system)

• Metabolic Kitchen: Metabolic kitchen services and PECRB staff access kitchen facilities for the preparation and packaging of carefully controlled meals and snacks for human subjects enrolled in metabolic research studies

RFI Invitation:

The NIDDK invites qualified and interested parties to submit written responses to this RFI by December 16, 2024, after which the NIDDK will review submitted materials to support the development of its acquisition strategy. All responses shall be limited to fifteen pages in length in addition to the general response requests included in Appendix A. Submitted responses will not be returned to the responding party.

This RFI solicits information solely for market research purposes. As such, it does not constitute a Request for Quote (RFQ) or a commitment to issue an RFQ by the NIDDK. The information provided by the responding party will neither be evaluated nor considered as an offer. This RFI does not commit the NIDDK to contract for any supply or service. Additionally, the NIDDK not responsible for any administrative costs incurred by any responding party in response to this RFI.

The provision at FAR 52.215-3, Request for Information or Solicitation for Planning Purposes applies to this market research document.

Request for Information or Solicitation for Planning Purposes (Oct 1997)

(a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation.

(b) Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.

(c) This solicitation is issued for the purpose of: obtaining price, feasibility, and industry capabilities for planning purposes.

Information Requested of the Offeror:

1. Please complete the requested information using the response tables in Appendix A detailing your organization’s profile (e.g. general, company, active/live client information, etc.).

2. What is the feasibility of the solution detailed in the Solution Overview section? Please consider any applicable security measures.

a. What are the risks and considerations for the overall solution?

i. If necessary, please detail potential alternatives that can successfully substitute the solution highlighted in this RFI.

3. What is the feasibility for a single vendor to orchestrate the services outlined within this RFI?

a. What are the opportunities and limitations of that strategy?

i. Please detail any recommended contract vehicles and acquisition considerations.

4. Please provide types and approximate number of personnel required to carry out the work listed in each task area of the Solution Overview Section.

5. What information would you need to efficiently describe and price the appropriate solution in an

RFQ?

6. Which tasks are carried out by the contractor, (and which tasks and incidents remain under the responsibility of the NIDDK)?

7. How is increase of usage or peaks handled, and what are the corresponding costs?

8. How do you screen your employees or contractors?

9. Does your solution rely on vendor-specific or product-specific capabilities which would hinder

NIDDK from moving to another provider?

Respondents are required to limit their responses to fifteen pages, in addition to the requests in Appendix A, and should refrain from providing materials that are not relevant to this request (e.g. marketing materials).

Government Point of Contact (GPOC):

Please send responses to:

Amber Harris Contracting Officer amber.harris@nih.gov

Email Subject Line: Request for Information – <Insert Organization Name>: PECRB Support Services

Disclaimer and Important Notes:

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 has 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 and solicitation may be published.

Confidentiality:

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).

mailto:amber.harris@nih.gov

Appendix A – General Response Tables Organization Profile

General Vendor Response Company name.

Address.

City.

State.

Zip.

Country.

Primary Contact.

Title.

Phone.

Company Vendor Response Number of years in business overall.

Location of corporate and administrative services.

Applicable Federal Certifications.

Number of employees.

Current / former federal clients for which your company has performed similar service(s).