FDA Occupational Health Services (OHS) Clinical Services

Sources Sought Notice 1199156 U.S. Food and Drug Administration (FDA) - Office of the Commissioner (OC) - Occupational Health Services (OHS)- Office of Laboratory Safety and Science (OLSS) - Clinical Services THIS IS NOT A REQUEST FOR PROPOSALS/QUOTES - THIS IS A SOURCES SOUGHT NOTICE/REQUEST FOR INFORMATION, AND INFORMATION SUBMITTED WILL BE USED FOR MARKET RESEARCH PURPOSES ONLY. This Sources Sought/Request for Information (RFI) is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to identify small businesses (i.e., Small Businesses, SBA Certified 8(a) Small Businesses, Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB) that are capable of providing the full range of services described in this RFI and the draft statement of work (SOW). FDA will use this market research information to assess the market's capability to successfully meet FDA OC/OHS's requirements for Clinical Services. FDA welcomes responses from all interested small businesses. FDA does not intend to make a decision or award a contract on the basis of responses nor otherwise reimburse interested sources for the preparation of any information submitted for FDA's use of such information. FDA reserves the right to contact vendors if additional information is required. Overview: The U.S. Food and Drug Administration (FDA) is the nation's primary federal agency responsible protecting and advancing public health. In addition, FDA plays a significant role in the Nation's counterterrorism capability. To perform these duties, FDA employs attorneys, biologists, chemists, computer specialists, consumer safety officers, engineers, medical officers, pharmacists, statisticians, and administrative personnel. The FDA headquarters is located on the 130-acre White Oak campus. There are multiple field locations located throughout the US and overseas. The Agency has six product-oriented centers in addition to a worldwide field force to carry out its mission. The FDA encounters environmental, sociological, and occupational health matters like those found on the campuses of major universities. Through Occupational Health Services (OHS), the Office of Laboratory Safety and Science (OLSS) provides a comprehensive medical program for employees, visitors, and guest workers of the FDA per 29 CFR Part 1910 and 1960.80. These services include emergency/urgent medical care, work-related medical evaluations, medical care for occupational injuries and illnesses, work-related travel medical support, health surveillance programs (including immunizations), and employee counseling services. Moreover, the OLSS provides leadership in the development and implementation of occupational health and safety policies, standards, and procedures designed to create, promote, and support a safe and healthful research and regulatory environment. The OLSS encompasses both the Office of the Director and Employee Safety and Environmental Management Staff. While the operations of the OHS clinics are conducted by contract, occupational medical health and surveillance are an integral part of OLSS. Occupational Health Services supports approximately 25,000 FDA employees, including contractors. Approximately 16,000 employees, roughly 55 percent of the FDA workforce are located in the National Capital Region. The remaining approximate 9,000 employees are located at FDA laboratories and field offices throughout the country and across the world. These field locations include the National Center for Toxicology Research (in Arkansas), over 200 hundred field offices of the Office of Regulatory Affairs, and multiple laboratory facilities. Currently, occupational health services are provided for FDA employees through an Interagency Agreement (IAA); the Chief Medical Officer, Occupational Health Services is the Technical Expert for this IAA. There are 298 Health and Wellness Centers located in Federal buildings throughout the United States as well as a large network of more than 15,000 private-provider physicians and nurses. Federal Occupational Health operates the Health and Wellness Centers as well as five FDA Occupational Health Units in the National Capital Region (NCR). The clinical staff in the NCR are provided through a subcontracting agreement. It is expected that this new contract will increase operational and management efficiencies and thereby improve current provision of occupational health services. The Food and Drug Administration requires clinical services to FDA/OC/OHS/OLSS to achieve the following objectives: Efficiently sustain the workplace health and safety of FDA employees; Provide occupational health and clinical services, counseling, and training to FDA employees, and guest workers at the National Capital Region Health Units and at all FDA field locations nationwide and internationally; Comply with occupational health and safety regulatory requirements and guidelines; and Maintain a high-level of employee satisfaction with the clinical services received. The FDA seeks to acquire contractor support to provide all necessary personnel and management to conduct a comprehensive occupational medical program for the FDA. Specifically, the FDA seeks contractor support in sustaining the workplace health and safety of all FDA employees through provision of occupational health services (e.g. counseling, and training). It is the Government's intention to award a five (5) year Indefinite Delivery Indefinite Quantity (IDIQ) contract. General Instructions: Respondents to this notice must provide the following information: - Completed "Vendor Feedback Form" - CPARS evaluations for any contract identified in the Vendor Feedback Form - Capability Statement - Capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting - A Cover Page that includes the following" 1. Company Name and Address 2. DUNS Number 3. Point of Contact (Name, Email, and Phone Number) 4. Email Subject: Request for Information- FDA-18-223-RFI-1199156 Responses to the RFI should not exceed 10 pages in length. The page limitation does not include the attached RFI 1199156 Vendor Feedback Form, completed CPARS evaluations, or comments on the attached draft documents. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g., The response must go beyond the statement that, "XYZ company can provide the requested services."). Please provide documentation of the size of your business for the selected North American Industry Classification System (NAICS) code: 621498- All Other Outpatient Care Centers. Attachments: 1. Draft SOW: See attached DRAFT statement of work (SOW), which is subject to change. Potential offerors responding to this notice are highly encouraged to review the attached DRAFT SOW, and provide comments and feedback using the Tracked Changes and comment features found in MS Word. 2. RFI 1199156 Vendor Feedback Form - Potential offerors must complete the attached response sheet and submit with their RFI submission. 3. DRAFT FDA Sites Supported by OHS, which is subject to change. 4. DRAFT FDA Field Office Locations, which is subject to change. 5. DRAFT Clinic Supply List, which is subject to change. 6. DRAFT Labor Categories, which is subject to change. Potential offerors responding to this notice are highly encouraged to review the attached DRAFT Labor Categories, and provide comments and feedback using the Tracked Changes and comment features found in MS Word Responses to this notice must be submitted via email to Kenneth Bailey (Kenneth.Bailey@fda.hhs.gov) and Michelle Creenan (Michelle.Creenan@fda.hhs.gov). Responses will not be accepted by any other means. Responses are due by 5:00 PM Eastern Time (ET), Thursday, November 1, 2018. Late responses may not be considered. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for quote/proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. The result of this market research will contribute to determining the method of procurement.