Sol_Amend_1_75F40124R00003.pdf

Food and Drug Administration

Occupational Health Services IDIQ

Competitive RFP 75F40124R00003 Amendment 1

75F40124R00003 Amendment 1

Table of Contents

1. Notices

2. Pricing Schedule

3. Pricing Terms

4. IDIQ Contract Type

5. IDIQ Contract Value

6. IDIQ Contract Ordering

7. Background

8. Objectives

9. Scope

10. Task Areas

11. Personnel

12. Packaging, Marking and Shipping Instructions

13. Inspection and Acceptance

14. Period of Performance

15. Government Closures

16. Place of Performance

17. Travel

18. Deliverables

19. Deliveries

20. Post‐Award Evaluation of Contractor Performance

21. Government Points of Contact

22. Government Furnished Property

23. Government Furnished Information and Government Furnished Equipment

24. Government Furnished Data and Materials

25. Other Direct Costs and Order Level Materials

26. Non‐Personal Services and Inherently Governmental Functions

27. Reporting Matters Involving Fraud, Waste and Abuse

28. Briefings

29. Identification of Contractor Employees

30. Organizational Conflicts of Interest

31. Invoicing

32. Security and Privacy Language

33. Privacy Act

34. Occupational Safety and Health Terms And Conditions

35. Contractor Personnel Security Clearance Standards and Residency Requirements (Oct 2017)

36. Contract Clauses

37. List of Attachments

38. Solicitation Provisions

39. Instructions to the Offerors

40. Basis of Award and Evaluation Criteria

1. Notices

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This solicitation is issued as a request for proposal (RFP) in accordance with the procedures of FAR Part 12, Acquisition of Commercial Products and Commercial Services, in conjunction with the policies and procedures for solicitation, evaluation and award prescribed in FAR Part 15, Contracting by Negotiation.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024‐01, effective November 14, 2023.

This solicitation is being competitively set‐aside to 8(a) small business concerns. The associated North American Industry Classification System (NAICS) code is 621111, Offices of Physicians (except Mental Health Specialists). The associated small business size standard is $16 million.

Offerors must have an active registration in SAM.gov (www.sam.gov), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors without an active registration in SAM.gov will not be considered.

2. Pricing Schedule

The Contractor’s pricing schedule for labor categories shall contain fully burdened hourly rates. The fully burdened hourly rates for each labor category shall include wages; indirect costs: fringe benefits, overhead, general and administrative, profit; and any other fees and charges. Hourly rates shall apply to services at both Government and non‐Government sites.

ORDERING PERIOD I

Government IDIQ Labor Category Firm Fixed Price IDIQ Labor Rate

Labor Hour IDIQ Labor Rate

Program Manager Project Manager Nurse Manager (National Capital Region Clinical Coordinator) Physician (Occupational Medicine) On‐Call Physician (Occupational Medicine/Infectious Disease) Optician/Optometrist Physician (Ophthalmologist) Physician Assistant Nurse Practitioner Nurse (Certified Occupational Health Nurse) Nurse (without Certified Occupational Health Nurse) Certified Medical Technician (CMT II) Administrative Assistant

ORDERING PERIOD II

Firm Fixed Price IDIQ Labor Rate

Labor Hour IDIQ Labor Rate

Program Manager Project Manager Nurse Manager (National Capital Region Clinical Coordinator) Physician (Occupational Medicine) On‐Call Physician (Occupational Medicine/Infectious Disease) Optician/Optometrist Physician (Ophthalmologist) Physician Assistant Nurse Practitioner Nurse (Certified Occupational Health Nurse) Nurse (without Certified Occupational Health Nurse)

ORDERING PERIOD III

Firm Fixed Price IDIQ Labor Rate

Labor Hour IDIQ Labor Rate

Program Manager Project Manager

Nurse Manager (National Capital Region Clinical Coordinator)

Physician (Occupational Medicine) On‐Call Physician (Occupational Medicine/Infectious Disease) Optician/Optometrist Physician (Ophthalmologist) Physician Assistant Nurse Practitioner Nurse (Certified Occupational Health Nurse) Nurse (without Certified Occupational Health Nurse)

ORDERING PERIOD IV

Firm Fixed Price IDIQ Labor Rate

Labor Hour IDIQ Labor Rate

Program Manager Project Manager Nurse Manager (National Capital Region Clinical Coordinator) Physician (Occupational Medicine) On‐Call Physician (Occupational Medicine/Infectious Disease) Optician/Optometrist Physician (Ophthalmologist)

Physician Assistant Nurse Practitioner Nurse (Certified Occupational Health Nurse) Nurse (without Certified Occupational Health Nurse)

ORDERING PERIOD V

Firm Fixed Price IDIQ Labor Rate

Labor Hour IDIQ Labor Rate

Program Manager Project Manager Nurse Manager (National Capital Region Clinical Coordinator) Physician (Occupational Medicine) On‐Call Physician (Occupational Medicine/Infectious Disease) Optician/Optometrist Physician (Ophthalmologist) Physician Assistant Nurse Practitioner Nurse (Certified Occupational Health Nurse) Nurse (without Certified Occupational Health Nurse)

TOTAL ESTIMATED IDIQ MAXIMUM (ALL PERIODS) $25,000,000.00

3. Pricing Terms

The Contractor shall comply with FAR Clause 52.212‐4, Contract Terms and Conditions – Commercial Items (NOV 2023) in regard to the firm‐fixed‐prices for individual task orders. The total amount specified in Firm‐ Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the order.

The Contractor shall comply with FAR Clause 52.212‐4, Alt I, Contract Terms and Conditions – Commercial Items (NOV 2021) with regard to the ceiling price for each Time‐and‐Materials and Labor‐Hour type task order.

4. IDIQ Contract Type

This is anticipated to be a single‐award Indefinite Delivery‐Indefinite Quantity (IDIQ) type contract with the following authorized order types for task orders: Labor‐Hour (LH), Time‐and‐Materials (T&M), and Firm‐Fixed‐Price (FFP), or a combination thereof.

5. IDIQ Contract Value

5.1. IDIQ Minimum

The minimum guarantee for this IDIQ contract is $3,000.00, which will be obligated to the IDIQ at the time of IDIQ award or will be obligated to a task order issued concurrently at the time of IDIQ award.

5.2. IDIQ Maximum

The maximum aggregate dollar value of all task orders awarded over the 5‐year ordering period of this IDIQ shall not exceed the IDIQ ceiling amount of $25,000,000.00.

See FAR Clause 52.216‐19 (Oct 1995) for individual task order limitations.

6. IDIQ Contract Ordering

A Request for Task Order Proposal (RFTOP) will be issued via email for individual task orders. Task Orders against the IDIQ contract will be in accordance with FAR Subpart 16.505 and FAR Clause 52.216‐18 (Aug 2020).

Proposals submitted in response to a RFTOP must use labor rates equal to or less than the established IDIQ Ordering Period labor rates listed in the pricing schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period; however, if a task order’s performance period is longer than twelve (12) months, the Contractor may propose the applicable ordering period rate for that portion of the performance period after the twelve (12) month period. The Contractor may propose lower rates in response to a RFTOP. RFTOPs may include option periods in accordance with FAR clause 52.217‐9; however, the following limitation applies to task orders with option periods:

The performance period end date of the last option cannot exceed twelve (12) months past the performance end date of the IDIQ contract.

The terms and conditions of the IDIQ contract apply to task orders.

7. Background

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. In order to perform these duties, FDA employs attorneys, biologists, chemists, computer specialists, consumer safety officers, engineers, medical officers, pharmacists, statisticians, and administrative personnel. FDA headquarters is located on the 130‐acre White Oak campus. There are multiple field locations located throughout the United States, U.S territories and around the world. The Agency has six (6) product‐oriented centers in addition to a worldwide field force to carry out its mission.

The FDA encounters environmental, sociological, and occupational health matters similar to those found on the campuses of major universities.

The FDA employee population is diverse nationally, culturally, and ethnically, and for many, English is a second language. The population is comprised of professional, scientific, law enforcement, administrative, technical, clerical, and blue‐collar personnel. There are 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 locations throughout the country and around the world.

These laboratories primarily analyze food, drugs or medical devices regulated by the FDA to verify conformance with FDA standards, but also conduct research, forensic analyses or other specialized work in some cases.

These field locations include District Offices, Field Offices, Office of Criminal Investigations (OCI) offices, Resident Posts, Border Stations, Mail Facilities, Domicile Offices, and Resident Offices. These locations primarily provide office space for many of the employees assigned to the field locations to carry out the regulatory mission of the FDA. (See Attachment 2 – Building Locations and Estimated Headcounts).

Numerous laws and Executive Orders create the need for occupational health, wellness, and safety programs within federal agencies. These laws include the requirements of Federal Employee Occupational Safety and Health Programs (29 CFR 1960) and Occupational Safety and Health Administration (29 CFR 1910). Executive Order 12196, entitled “Occupational safety and health programs for Federal employees,” provides federal agencies with additional occupational health and safety directives. Additionally, 5 U.S.C.

7901 authorizes federal agencies to provide health services that promote and maintain the physical and mental fitness of employees. Through Occupational Health Services (OHS), the Office of Laboratory Safety and Science (OLSS) provides a comprehensive work‐ related medical program at the FDA to comply with these legislative demands. OHS 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 wellness and counseling services.

Previously, access to occupational health services was provided for FDA employees across the country through an Interagency Agreement (IAA) with Federal Occupational Health (FOH) through HHS PSC (Program Support Center). Currently there is an IDIQ with Eagle Health to provide these services. There are four (4) FDA Occupational Health Units in the National Capital Region. These Occupational Health Units are located at 1) White Oak; 2) College Park; 3) Metro Park; and 4) Muirkirk Road Complex‐ Laurel.

Additionally, EH provides FDA employees access to a network of Health and Wellness Centers located within fifty (50) miles of all FDA offices in the United States. This ensures that FDA field staff have equal access to the occupational health services available to staff in the national capital region. FDA field employees require access to occupational health services through this contract.

8. Objectives

The FDA objectives for this IDIQ are to:

• Efficiently sustain the workplace health and safety of FDA employees

• Provide occupational health and clinical services, counseling, and training to all FDA employees, visitors, designated contractors, and guest workers at the National Capital Region Health Units and at all FDA field locations.

• Comply with occupational health and safety regulatory requirements and guidelines

• Maintain a high‐level of employee satisfaction with the clinical services received

9. Scope

The scope of this IDIQ is to provide occupational health services for the FDA. This shall include providing program and project management, transition services, Occupational Health Unit operation, and medical services to include, but not limited to, vaccination and surveillance programs. The surveillance programs serve to detect and eliminate health issues related to workplace duties and exposures.

10. Task Areas

10.1. Task 1: Program Management

The Contractor shall provide Program Management support for the OHS requirement. Program Management and Project Management support includes the effort to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective occupational health work activities throughout the contract’s period of performance. Additionally, the Contractor shall provide Program Management services to establish control, management, monitoring, and notification mechanisms for the OHS requirement. Moreover, the Contractor shall work with the Government Contracting Officer (CO), Government Technical Lead (GTL), Contracting Officer’s Representative (COR), and subject matter experts (SMEs) to ensure that tasks stay on track and important milestones are met. Representative activities shall include, but are not limited to:

Administering the contract;

o Plan, structure, coordinate, monitor & manage costs, schedule, manage, communicate, report, and steward all respective OHS activities

Developing and maintaining plans, risk management plans, staffing plan, Standard Operating Procedures (SOP), Protocols, and Manual of Procedures;

Preparing a Program Management Plan (PMP) describing the technical approach, organizational resources and management controls throughout contract execution, per section C.4.1.1. Establishing structured pro‐active process to notify the FDA when FDA inputs are required (e.g., approval of a decision, change review);

Identifying risks and providing risk mitigation, per section C.4.1.5;

Safeguarding data and information;

Managing contractor staff;

o Ensure contractor staff obtain an FDA Badge;

Coordinating the provision of occupational health services to FDA field staff;

Conducting and participating in meetings in different capacities (e.g., kick‐off, progress meetings, facility meetings, training meetings, performance meetings, program/project reviews, management briefings, stakeholder presentations, demonstration meetings, transition meetings, and COR site visits, and post requirements meetings);

o Preparing and tracking meeting agendas, minutes, issues, risks, and action items/work activities.

Responding to ad hoc data calls, including, but not limited to, providing OSHA data to the COR or GTL;

Preparing workload statistics and staffing responsibilities reports, as required in the contract;

Ensuring that all personnel have the expertise, knowledge, training and possess appropriate knowledge and skills to meet their labor categories as defined in the contract;

Developing findings and recommendations for committee discussion; and

Working with the GTL to take actions deemed necessary by the committees or councils.

10.1.1. Program Management Plan

The Contractor shall provide a Program Management Plan (PMP). This plan shall include:

The management approach, organizational structure, organizational resources, and management controls to be used to meet the requirements throughout the contract’s period of performance;

The process to oversee and manage work activities;

The process to recruit, train, and retain personnel; and

A communication diagram illustrating all lines of communication between the Government and the Contractor.

10.1.2. Annual Requirements

The Contractor shall provide an Annual Report (AR) to the assigned COR, CS, and CO, incorporating all tasks at a high level and their progress. Within the first thirty (30) business days after award, the Government and the Contractor shall design and agree upon a standard reporting format and timeframe. At a minimum, each AR shall contain the following information:

List of Clinic Standard Operating Procedure Updates

Inventory of Electronic Equipment

Continuing Education Plan, and

Information Security Assessment

10.1.3. Monthly Status Reports

The Contractor shall provide a Monthly Status Report (MSR) to the assigned COR, CS, and CO incorporating all tasks at a high level and their progress. Within the first thirty (30) business days after award, the Government and the Contractor shall design and agree upon a standard reporting format and timeframe. At a minimum, each MSR shall contain the following information:

The previous month’s activities (completed and in‐progress);

Deviance from previous month’s planned progress (either positive or negative);

The current month’s planned activities (complete and in‐progress);

Risks and planned mitigations;

Documentation of changes in staffing;

Performance and Cost Report (P&CR): the P&CR shall include all recurring and non‐ recurring costs, cumulative cost, total labor hours, and cumulative labor hours for each task area for the previous month;

The status of the action items from any Kickoff Meetings and other follow‐on meetings, as appropriate;

The MSR must be submitted via email on the third business day of the month to the COR, CS and CO;

Customer satisfaction with the services provided through use of surveys;

Quality and reliability of the care provided as assessed by medical record reviews; and

Inventory and inventory requisition status.

10.1.4. Project Meetings

As tasked under this contract, the Contractor shall participate in meetings and discussions that support the overall efforts of the requirement work activities (e.g., kick‐off and task related meetings). The Contractor shall participate in different capacities, such as leading discussions;

contributing questions and answers; raising issues, risks and concerns; and developing and giving presentations. The Contractor shall prepare and track meeting agendas, minutes, issues, risks, and action items as requested by the Government. Meeting minutes must be of sufficient detail to accurately document meeting date and location, meeting purpose, items discussed, decisions made, attendees, and action items.

Representative activities include, but are not limited to:

Coordinating quarterly project meetings to plan, strategize, and execute occupational health programs and projects;

Preparing and distributing agendas to include call‐in/teleconference information and review materials;

Completing and distributing meeting minutes and action items to meeting participants;

and

Tracking of meeting minutes, action items, and associated materials relating to all meetings/calls.

10.1.5. Risk Management

The Contractor shall identify, report, and address for resolution to the Government any issues that prevent the Contractor from performing the work activities in the contract that the Contractor is unable to resolve independently. Clinical and administrative systems, processes, procedures, and reporting structures designed to detect, monitor, assess, mitigate, and prevent medical errors must be implemented and documented. The Contractor shall document and report identified risks to include sentinel events, other medical errors, and near misses, as well as opportunities within a risk registry. The Contractor shall maintain the risk registry and provide it to the assigned COR, CS, and CO monthly. The risk registry must contain, at a minimum, unless otherwise specified:

Issue Number: a sequential numbering of all issues;

Severity: assessment of issue severity, i.e., likelihood and consequences (High/Medium/Low);

Date Found: date that issue was identified by the Contractor;

Duration: number of days that issue has been open;

Status: representing issue status as open or closed. The Contractor shall maintain a complete list of all issues – no issues should typically be deleted from the Contractor’s delivered list;

Title: short description of issue;

Updated: date for updated status;

Details: narrative description of activities that have been completed to resolve issue;

Assigned To: identify Government POC or Contractor that is assigned to resolve the issue;

and

Solution or Workaround: description of the actions and activities taken to resolve or mitigate the issue.

10.1.6. Delivery Instructions for Deliverables

All reports or copies of reports shall be delivered to the COR. Requirements for inspection and acceptance are as follows:

The COR will inspect and accept the services provided to ensure they meet the requirements detailed in the contract.

The Government will accept products and services only if they conform to all terms and conditions of the contract.

The Government will provide written notification of acceptance or rejection within ten

(10) business days of receiving the service.

The Government will reject non‐conforming products and services. The Contractor shall correct any deficiencies within fifteen (15) business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan, subject to FDA approval, within ten (10) business days.

10.2. Task 2: Transition Services

Transition activities shall take place to efficiently transition all activities from the current OHS provider to the Contractor. As tasked, the Contractor shall develop transition–in and transition‐out plans and conduct transition activities.

10.2.1. Transition‐In

The Contractor shall transition‐in and assume the responsibility for activities and duties from the current OHS provider in a manner that does not interrupt or negatively impact FDA’s provisioning of occupational health services or operations. The purpose of the Transition‐in requirement is to provide an orderly transition from the current OHS provider. The Contractor shall work with the current OHS provider to ensure a smooth transition of work from one contractor to the other.

Developing a Transition‐in Plan to ensure full operating accountability and responsibility of the contract.

Conducting and coordinating all on‐boarding activities, to include the badging for team personnel.

Reviewing objectives, processes, and requirements as related to the tasks and activities being performed.

Coordinate with assigned OHS provider to obtain access to required data and Government furnished equipment.

Participating in Transition‐in meetings (initially to be held jointly with the current OHS provider).

Participating in other information exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the current OHS provider.

Ensuring Contractor personnel are available to work within six (6) weeks after award

Certifying that employees working on the contract have completed a review of FDA and OHS policies and understand the requirements, documentation, and processes prior to the completion of the Transition‐in activities.

Verifying to the COR that all the Transition‐in documents are available.

10.2.2. Transition‐Out

The Contractor shall conduct the transition‐out of contracted activities and services to a successor contractor by the end of the contract period of performance. If a successor contractor has not been identified, the Contractor shall transition contracted activities and services to the FDA.

Between the turnover date designated by the COR and the end of the contract period of performance, the Contractor shall ensure all contract activities are closed out and the Contractor shall provide sustainment support to complete the transition, ensuring no degradation in support provided under the contract.

Developing and submitting a Transition‐Out Plan and Schedule to the COR.

Providing the FDA with current versions of all documentation developed (e.g., Standard Operating Procedures and Manual of Operations).

Providing the FDA with a current inventory of all Government‐Furnished Equipment (GFE) and Government Furnished Information (GFI) utilized by the Contractor, along with full support in the reconciliation of this inventory.

o Return to FDA all GFE that has not been transferred to the successor contractor.

Providing the successor contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

10.3. Task 3: Operate Occupational Health Units & Provide Occupational Health Services to all

FDA Personnel

10.3.1. Operate, Staff and Supply Occupational Health Units & Provide Occupational Health Services to all FDA Personnel

The Contractor shall provide occupational health services using on‐duty medical personnel during the hours of operation. The Contractor shall provide all necessary supplies to operate these facilities; provide medical services for biological and/or chemical emergencies, injuries, and illnesses; and provide services in accordance with the FDA Occupational Health Unit Standard Operating Procedures. The Contractor shall operate and maintain Health Units with persons qualified and able to provide a comprehensive array of OHS services as required by the program and specified in the OHS Standard Operating Procedures. The Contractor shall utilize the FDA’s Electronic Medical Record System (EMRS) to document and track appointments, clinical encounters, incident reports, immunizations, and surveillance programs. The Contractor shall establish, maintain and update a medical equipment maintenance and certification schedule for FDA medical equipment and devices based on equipment manufacturer guidelines.

Operating and staffing the four (4) National Capital Region Satellite Health Units;

Providing occupational health services through a nationwide system of occupational health, travel medicine clinics, and/or community partners to FDA field staff (See Attachment 2 – Building Locations and Estimated Headcounts);

Administering Special Programs, as needed and approved by the COR;

Maintaining a sufficient inventory of all medical supplies needed in the clinics;

Maintaining a sufficient inventory of all medications needed in the clinics;

Scanning, uploading, and incorporating paper medical records into the FDA EMRS;

Following procedures that ensure that FDA meets its responsibilities under the Privacy Act:

o Treat all hard copy and electronic employee health records as medically confidential.

o Maintain the necessary security for the records.

o Ensure appropriate dissemination of pertinent medical clearances to relevant personnel.

o Maintain accurate, complete, current medical records in the EMRS and, as relevant, in hard copy. This shall include all: visits, diagnostic assessments, treatments provided, and other relevant medical data as OHS obtains and is appropriate.

o Prepare and maintain an individual file for each employee beginning with th employee’s first visit to the clinic.

o Maintain FDA’s Records Management program, archiving records appropriately according to the FDAs records schedule.

Providing quality control review of employee medical records in the FDA EMRS and reporting and remedying any issues or inconsistencies in the medical record to the GTL;

Adjusting or modifying the staffing plan over a short‐term specified period in consultation with the COR; and

Reviewing each health unit’s operations and recommending enhancements to policies and procedures.

10.3.2. Provide Medical Services

The Contractor shall administer outpatient medical care at all Health Units during operating hours.

All medical services shall be provided to federal FDA Full‐Time Employees (FTEs). The Contractor shall provide medical services to non‐federal employees, as per clinic SOPs, as monitored by the COR and GTL.

Responding to requests for emergency medical care in the clinic;

o The Contractor shall provide medical support for all medical emergencies that occur on FDA premises regardless of the employment status of anyone involved.

Responding to occupational injuries and illness visits and emergencies occurring during clinic hours;

o The Contractor shall record the circumstances of each occupational injury utilizing the FDA EMRS and in accordance with FDA policies.

o If the injury or illness is reported within 24 hours of its occurrence and is work‐ related, the Contractor shall provide initial care for the injury to the injured worker, regardless of their employment status.

Providing telephone triage by an infectious disease and occupational medicine specialist for occupational injuries and illnesses, including, but not limited to, biological and chemical emergencies, occurring after clinic hours.

o The Contractor shall record the circumstances of each occupational injury utilizing the FDA EMRS and in accordance with FDA policies.

o The Contractor shall provide an initial assessment, via telephone triage, to any individual that may be experiencing symptoms of an FDA work‐related illness or injury.

Responding to exposures to biological and/or chemical hazards during clinic hours:

o The Contractor shall provide initial and related follow‐up care to all federal and non‐ federal workers whose injury involves a potential exposure to a hazard that could not readily be treated in the community or is of special interest to the FDA.

Examples of these hazards include: human immunodeficiency virus (HIV‐1), Macacine herpesvirus 1 (B virus), human pathogens studied in BSL/ABSL‐3 laboratories, and some radioisotopes.

Providing additional occupational health medical services, as approved by the GTL and

COR;

Providing travel medicine support for work‐related international travel;

Providing medications on site, as needed to address work‐related injuries, minor illnesses, and travel medicine visits;

Providing absence and disability management, to include completing Return to Work Assessments;

Completing Fitness for Duty Evaluations;

Providing Laboratory Support Services, including, but not limited to, phlebotomy services, processing of body fluids for laboratory testing, serum storage, shipping and receiving of body fluids for specialized testing at facilities in other states, and tracking and recording laboratory test results;

Administering the Vision Protection Program, including, but not limited to, providing vision screenings, eye examinations, and provision and maintenance of specialized optical devices such as safety spectacles o The Contractor shall provide ophthalmology and optometric services in the White Oak Health Unit for at least four (4) hours per month.

o The Contractor shall provide these services to all FDA employees in the field through agreements with local ophthalmology and optometrist service providers.

Providing preliminary or palliative treatment of medical conditions for which the employee would not normally seek the attention of a personal physician to enable the individual to complete his or her current work shift more comfortably;

Administering medications by injection as prescribed by a personal physician, such as allergy and B12 shots;

Issuing limited prescriptions of medications;

Offering special health and wellness promotion/screening programs; and

Reviewing the medical services, screening programs, and wellness programs provided and recommending enhancements to policies and procedures.

10.3.3. Provide Immunization Services & Other Surveillance Programs

The Contractor shall provide immunization services to the FDA. The Contractor shall supply the vaccinations. These immunizations include but are not limited to: anthrax; hepatitis A and B viruses; human papilloma virus; influenza viruses; Japanese encephalitis virus; measles, mumps, and rubella viruses; meningococcus; polio viruses; rabies virus; tetanus, diphtheria, pertussis; tick‐ borne encephalitis virus; typhoid; vaccinia viruses; varicella‐zoster virus; and yellow fever virus.

(See Attachment 9 – Sample Supply and Services List)

The Contractor shall provide the influenza vaccine to federal employees, Oak Ridge Institute for Science and Education (ORISE) fellows, Interagency Oncology Task Force Fellows, and Commissioner’s Fellows and to certain non‐federal FDA employees, as per Clinic SOPs.

The Contractor shall administer other cohort and surveillance programs, as directed by the COR and GTL. Additionally, the Contractor shall notify and schedule participants through the FDA EMRS, and perform the procedures specified in the respective program. The Contractor shall provide services to non‐federal employees enrolled in job‐related surveillance programs.

Administering various immunization programs and services, including, but not limited to, anthrax; hepatitis A and B viruses; human papilloma virus; influenza viruses; Japanese encephalitis virus; measles, mumps, and rubella viruses; meningococcus; polio viruses;

rabies virus; tetanus, diphtheria, pertussis; tick‐borne encephalitis virus; typhoid; vaccinia viruses; varicella‐zoster virus; and yellow fever virus.

Administering vaccinations to comply with the surveillance programs.

Recalling workers for booster doses and identifying workers who fail to comply with recommendations to receive a vaccine required for work with a biohazard (e.g., anthrax, rabies, vaccinia vaccines) using FDA EMRS as appropriate.

Administering other mass immunization efforts, as coordinated and scheduled by the GTL and the COR.

Administering other surveillance and cohort procedures, including, but not limited to, Respiratory Protection Program; Animal Exposure Program Medical Services; Select Agent Program; Hearing Conservation Program; Vision Protection Program; and Pathogen‐ Specific Procedures.

Reviewing the immunization programs and surveillance and/or cohort programs provided and recommending enhancements to policies and procedures

10.3.3.1. Animal Exposure Program Medical Services

The Animal Exposure Program (AEP) Medical Services provides 1) health and safety information related to the use and care of animals, 2) occupationally indicated immunizations, and 3) clinical evaluation and treatment for animal‐related injuries or illnesses. The AEP tailors the medical services provided to the types of animals with which the employee works: small animals, large animals, nonhuman primates (NHP), and NHP tissues. The FDA requires all employees who have contact with animals or their living quarters, viable tissues, body fluids, or waste to participate in this program. Examples of the types of medical services which shall be required include, but not but are not limited to: record review, exam, consultation, illness/injury care, laboratory testing, vaccination, and medication administration. Specific medical services will be identified on the task order level.

Currently, there are approximately 500 participants in the AEP in the National Capital Region.

The vast majority of AEP‐related services are provided during an enrollment or annual visit.

10.3.3.2. Select Agent Program

The Select Agent Program (SAP) is designed as an overarching service for individuals who work in BSL/ABSL‐3 laboratories or have unrestricted access to either the biohazards stored there or to the facility’s critical infrastructure. The intent of the program is to determine whether workers are physically and psychologically fit to work in a BSL/ABSL‐3 laboratory environment.

Participants who have access to these biohazards also receive services defined in pathogen‐ specific procedures during their enrollment and annual SAP visits. (See Article C.4.3.3.4) The FDA requires both federal employees and Contractors who meet the criteria for this program to actively participate in it. The program requires extensive communication and coordination between the Contractor and other sections of the OLSS.

Currently, there are approximately 100 participants in the SAP across the FDA. Because of the complexity of these encounters and the extent of communication required, the Contractor should anticipate that these visits require significantly more time to process than other clinic visits.

10.3.3.3. Hearing Conservation Program

The Hearing Conservation Program will provide medical monitoring for employees who may be exposed at work to noise levels of 85 decibels (dBA) or higher on a time‐weighted basis during an eight‐hour day in a calendar year. The Contractor monitors employees for health effects from noise exposure and provides related counseling and literature.

Currently, there are less than 25 employees in the National Capital Region that may require surveillance.

10.3.3.4. Pathogen‐Specific Medical Surveillance

The Contractor shall provide pathogen‐specific occupational medical support for researchers working with a variety of human pathogens (e.g., B. anthracis, C. burnetti, flaviviruses, hemorrhagic fever viruses, influenza viruses, orthopox viruses, etc.). These services include pathogen‐specific employee consultation that screens for potential increased employee health risks and details the earliest clinical evidence of a laboratory acquired infection with the agents for researchers. The Contractor’s staff shall be familiar with FDA standard operating procedures for pathogen specific medical services and provide the related medical services to include counseling, vaccinations, and or prophylactic medications. Clinic visits related to these procedures are part of enrollment and annual surveillance visits.

Currently in the National Capital Region, there are approximately 500 participants in the Pathogen‐ Specific Medical Surveillance. The vast majority of services are provided during an enrollment or annual visit.

10.3.3.5. Office of Criminal Investigations Examinations

The Contractor will provide pre‐placement medical and annual medical evaluations for Office of Criminal Investigations (OCI) agents. There are less than 25 pre‐placement and annual medical evaluations are performed each year. After receipt of information from the Office of Human Resources (OHR), the prospective employee shall contact the contractor to schedule preplacement medical evaluations.

Elements of a pre‐placement or annual medical evaluation shall include:

Reviewing the functional demands and environmental fact of the proposed position;

Reviewing the worker’s responses to a self‐administered medical questionnaire;

Reviewing the worker’s medical and immunization history;

Measuring standard physical parameters (e.g., height, weight, blood pressure, and occasionally visual acuity);

Testing (e.g., tuberculin skin test, interferon gamma release assay, antibody testing, chest radiograph), as occupationally warranted;

The administration of appropriate work‐related immunizations (e.g., tetanus, measles mumps rubella, varicella‐zoster, etc.);

Providing information on potential health hazards that the employee may encounter while performing his or her duties;

Discussing the primary prevention strategies to minimize contact with potential occupational hazards; and

Informing the employee of the procedures to follow if any work‐related injury or illness occurs.

Currently, there are approximately 150 participants in OCI surveillance across the FDA.

Because of the complexity of these encounters and the extent of communication required, the Contractor should anticipate that these visits require significantly more time to process than other clinic visits.

10.3.3.6. Respirator Medical Clearance Evaluations

The Contractor may be expected to provide medical clearances for participants in the Respiratory Protection Program and coordinate their work with OLSS to ensure compliance with the Occupational Safety and Health Administration (OSHA) regulatory requirements.

Medical screening is done through the electronic medical record system

Currently, there are approximately 230 respirator clearance exams performed annually across the FDA for Respirator Medical Clearance.

10.3.3.7. Tuberculosis Surveillance Program

The Tuberculosis Surveillance Program (TBSP) seeks to minimize transmission of M.

tuberculosis at the worksite to employees at significant risk for occupational infection and for the protection of nonhuman primates at the FDA. Most enrollees in this program are AEP enrollees.

Currently, there approximately 30 TBSP enrollees at the White Oak campus.

10.3.3.8. Blood Borne Pathogen Exposure Control Program

The Blood Borne Pathogen Exposure Control Plan seeks to reduce the risk of occupational infection with blood borne pathogens by performing serologic testing and immunization of FDA employees exposed to human blood and/or blood products in addition to post‐exposure surveillance. The Contractor shall be responsible for tracking participants in this program, administering immunizations when there is a FDA licensed vaccine for the pathogen being handled, recalling them for periodic testing, and notifying them of laboratory test results.

Enrollment in this program will vary with the type of research underway at FDA

10.3.3.9. Onsite Health Assessments

Occasionally, FDA staff may be required to work in environmental extremes or hazardous environments during certain procedures. This will require presence of clinical staff on site at an ORA field office (See Attachment 2 – Building Locations and Estimated Headcounts). The staff will perform health assessments and provide treatment as per National Fire Protection Association 1584, Standard on the rehabilitation Process for Members During Emergency Operations and Training Exercises.

10.3.3.10. Other

The COR, in consultation with the Chief Medical Officer, may direct the Contractor to plan and administer similar surveillance programs and cohort procedures.

10.3.4. Provide Staff Training and Education

In order to promote a medically proficient and certified occupational health staff, the Contractor shall regularly provide opportunities for contractor staff training and education. The frequency of each training instance shall be clearly specified.

Implementing a staff orientation, to include FDA EMRS training;

Providing in‐service training to contractor staff;

Maintenance of necessary certifications; and

Supporting contractor staff’s Continuing OHS Education.

10.4. Other Requirements

10.4.1. OHS Governance Framework

This work shall fall under the current oversight and governance processes of the Chief Medical Officer, Occupational Health Services, Office of Laboratory Science and Safety, Office of the Commissioner, at the FDA. The Chief Medical Officer will be the Government Technical Lead (GTL) for the Occupational Health Services requirements. The GTL reserves the right to designate additional representatives, as needed.

If necessary, the Chief Medical Officer will utilize the relevant FDA committees and councils to address issues and specific priorities. The Chief Medical Officer will report issues to the committees on an as needed basis. The GTL will utilize the Contractor to develop findings and recommendations for committee discussion and the Contractor shall work with the GTL to undertake action deemed necessary by the committees or councils.

10.4.2. Medical Insurance/Identification

The Contractor shall procure, maintain, and provide evidence of Indemnification and Medical Liability Insurance.

10.4.3. Constraints

The following constraints are applicable to this contract:

The Privacy Act of 1974, Public Law 93‐579 (5 U.S.C. 552a ‐ Records maintained on individuals), that defines the rigid requirements for the handling of employee health records, available at https://www.hhs.gov/foia/privacy/index.html.

All applicable federal information technology and information management laws, regulations, policies and standards at the government‐wide, HHS and FDA levels.

o The computer programs, data management systems, databases, and other resources developed through this contract shall comply with data standards and procedures established by DHHS and FDA (per http://www.fda.gov/ForIndustry/DataStandards/default.htm).

FDA Security Authorization Process:

Security Authorization is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA), Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information resources have adequate security to protect the Confidentiality, Integrity and Availability of information collected, processed, transmitted, stored, or disseminated by the agency. For further information, see SP 800‐37 Rev. 1: Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach, available at http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800‐37r1.pdf.

New FDA Security Article entitled, Contractor Personnel Security Clearance Standards and Residency Requirements, dated October 2017

508 Standard Requirements:

All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at www.access‐ board.gov/508.htm.

National Institute of Standard and Technology (NIST) SP800‐53

This publication was developed by the Joint Task Force Transformation Initiative Interagency Working Group with representatives from the Civil, Defense, and Intelligence communities in an ongoing effort to produce a unified information security framework for the federal government— including a consistent process for selecting and specifying safeguards and countermeasures (i.e., security controls) for federal information systems.

SP 800‐53 Rev. 3: Recommended Security Controls for Federal Information Systems and Organizations.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

To improve the efficiency and effectiveness of the health care system, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104‐191, included Administrative Simplification provisions that required HHS to adopt national standards for electronic health care transactions and code sets, unique health identifiers, and security. At the same time, Congress recognized that advances in electronic technology could erode the privacy of health information. Consequently, Congress incorporated into HIPAA provisions that mandated the adoption of Federal privacy protections for individually identifiable health information.

o HHS published a final Privacy Rule in December 2000, which was later modified in August 2002. This Rule set national standards for the protection of individually identifiable health information by three types of covered entities: health plans, health care clearinghouses, and health care providers who conduct the standard health care transactions electronically. Compliance with the Privacy Rule was required as of April 14, 2003 (April 14, 2004, for small health plans).

o HHS published a final Security Rule in February 2003. This Rule sets national standards for protecting the confidentiality, integrity, and availability of electronic protected health information. Compliance with the Security Rule was required as of April 20, 2005 (April 20, 2006 for small health plans).

o The Enforcement Rule provides standards for the enforcement of all the Administrative Simplification Rules.

o HHS enacted a final Omnibus rule that implements a number of provisions of the HITECH Act to strengthen the privacy and security protections for health information established under HIPAA, finalizing the Breach Notification Rule.

o View the Combined Regulation Text ‐ PDF(as of March 2013). This is an unofficial version that presents all the HIPAA regulatory standards in one document. The official version of all federal regulations is published in the Code of Federal Regulations (CFR). View the official versions at 45 C.F.R. Part 160, Part 162, and Part 164.

o Other HIPAA Administrative Simplification Rules are administered and enforced by the Centers for Medicare & Medicaid Services, and include: Transactions and

Code Sets Standards, Employer Identifier Standard, and National Provider Identifier Standard

11. Personnel

The Contractor shall ensure that all personnel have the requisite expertise, knowledge, training, and possess appropriate credentials, which correspond to the identified labor categories, in order to meet the contract requirements. In addition, per HHSAR Clause 352.237‐75, the Contractor shall provide proper notice to the CS, the CO, and assigned COR when changing key personnel. Moreover, Key Personnel must be available to the Contracting Officer, GTL, and COR via telephone or in person, at a minimum, between the hours of 7:30am through 4:00pm, Monday through Friday, local time; and shall respond within four

(4) hours of notification for discussion and resolution of the problem(s).

The following labor categories are subject to the Service Contract Labor Standards:

IDIQ Labor Category Wage Determination Title Wage Determination Occupation Code

Nurse (Certified Occupational Health Nurse)

Registered Nurse II, Specialist

12313

Nurse (without Certified Occupational Health Nurse)

Registered Nurse II, Specialist

12313

Certified Medical Technician (CMT II) Medical Record Technician 12190

Administrative Assistant…