Att_2_OMS_Performance_Work_Statement.10.03.19.pdf

Section C

PERFORMANCE WORK STATEMENT 10/2/19

CONTENTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1 Performance Work Statement

ARTICLE C.2 Background C.2.1 Introduction C.2.2 Organization C.2.3 Population C.2.4 NIH Satellite Campuses and Facilities Supported by OMS C.2.4.1 Baltimore, Maryland C.2.4.2 Frederick, Maryland C.2.4.3 Hamilton, Montana C.2.4.4 Research Triangle Park, North Carolina C.2.4.5 Special Facilities

ARTICLE C.3 OMS Offices and Hours of Operation C.3.1 Main Clinic C.3.2 Satellite Clinic Locations C.3.2.1 Baltimore, Maryland C.3.2.2 Frederick, Maryland C.3.2.3 Hamilton, Montana C.3.2.4 Research Triangle Park, North Carolina C.3.3 EAP Office C.3.4 Intermittent OMS Locations

ARTICLE C.4 OMS Staffing C.4.1 Staffing during Routine Office Hours C.4.2 Staffing after Routine Office Hours C.4.3 Government Adjustments to Staffing C.4.4 Contractor Requests to Adjust Staffing

ARTICLE C.5 Clinical Care Elements C.5.1 Care for Non-Federal Employees C.5.2 Non-Urgent Medical Care Provided by Appointment C.5.2.1 Preplacement Medical Evaluations C.5.2.2 Immunizations C.5.2.3 Influenza Immunization Program C.5.2.4 Support for Investigational New Drug Research Studies C.5.2.5 Support for International Travelers

Section C – Performance Work Statement 2019

C.5.2.6 Physical Therapy C.5.2.7 Acupuncture C.5.2.8 Contact Studies C.5.2.9 Reviews of Medical Records C.5.2.10 Laboratory Support Services C.5.2.11 Other C.5.3 Non-Urgent Care provided via Recurring Appointments C.5.3.1 Animal Exposure Program C.5.3.2 Asbestos Medical Surveillance Program C.5.3.3 Biological Surety Program C.5.3.4 Hearing Conservation Program C.5.3.5 Police Officers and Firefighters Evaluations C.5.3.6 Tuberculosis Surveillance Program C.5.3.7 Other C.5.4 Urgent Care Provided without Appointment C.5.4.1 Occupational Injuries and Illnesses C.5.4.2 Occupational Injuries and Illness Emergencies Occurring After Clinic Hours C.5.4.3 Return to Work Assessments C.5.4.4 Emergency Medical Support C.5.4.5 Medical Care for Non-Occupational Injuries or Illnesses C.5.5 Community-Based Medical and Other Services C.5.5.1 Safety Eyeglass Program C.5.5.2 Department of Transportation Medical Evaluations C.5.5.3 Hazardous Materials Medical Evaluations C.5.5.4 Serum Storage C.5.6 Employee Assistance Program C.5.6.1 Overview C.5.6.2 Client Care C.5.6.3 Workplace Consultations with Supervisors and Others C.5.6.4 Interactions with Employee Relations C.5.6.5 Outreach Efforts C.5.6.6 Training C.5.6.7 Other

ARTICLE C.6 Essential Administrative Elements C.6.1 Procedure Manual C.6.2 Quality Control Plan C.6.3 Quality Improvement Plan C.6.4 Quality Assurance C.6.5 Risk Management Program C.6.6 Staff Training C.6.5.1 Staff Orientation C.6.5.2 In-Service Training C.6.5.3 Government Mandated Training C.6.5.4 Continuing Education C.6.6 Management Meetings

C.6.7 Records Management C.6.8 OSHA Data Collection C.6.9 Maintenance of Government Equipment and Supplies C.6.10 Support for Accrediting Organization Visits

ARTICLE C.7 Electronic Data Management Systems for OMS Clinics and the EAP C.7.1 Overview C.7.2 Administrative Database C.7.3 Program Modules C.7.3.1 Appointments and Scheduling C.7.3.2 Occupational Injury/Illness C.7.3.3 Cohort Procedures C.7.4 Security C.7.5 Program Expansion C.7.6 EAP Software

ARTICLE C.8 Staffing Plan and Personnel Requirements C.8.1 Key Personnel, Professional Staff, and Administrative Staff.

C.8.2 Key Personnel C.8.2.1 Contract Program Manager (CPM) C.8.2.2 Contract Deputy Program Manager (CDPM) C.8.3 Professional Staff C.8.3.1 Nurse Practitioner(s) C.8.3.2 Physician Assistant(s) C.8.3.3 Staff Nurses (RNs and LPNs) C.8.3.4 Clinical Research Coordinator(s) (CRC) C.8.3.5 Physical Therapist(s) C.8.3.6 Acupuncturist(s) C.8.3.7 Employee Assistance Program Counselors C.8.3.8 Employee Assistance Program Associate C.8.3.9 Certified Nursing Assistants (CNAs) C.8.3.10 Physician (per diem) C.8.4 Administrative Staff C.8.4.1 Medical Records Management Specialist(s) C.8.4.2 Medical Records Clerk(s)

ARTICLE C.9 Other Program Support and Requirements C.9.1 Subcontract Labor C.9.1.1 B Reader C.9.1.2 Pulmonologist C.9.1.3 Optometrist C.9.1.4 Employee Assistance Program Counselors (MT, NC) C.9.1.5 Community-Based Medical Support C.9.1.6 Serum Storage Repository in Maryland C.9.1.7 Additional Staffing Support C.9.2 Visiting Occupational Medicine Residents and EAP Counselors in Training

C.9.3 Support for NIH Field Stations C.9.4 Communications and Correspondence Originating in OMS C.9.5 Contacts with Community Healthcare Providers C.9.6 Presentations, Publications and Publicity

ARTICLE C.10 Reports and Deliverables C.10.1 Technical Progress Reports C.10.2 At Contract Start C.10.2.1 Employee Roster C.10.2.2 Procedure Manual Review C.10.3 Weekly Reports / Deliverables – Operational Updates C.10.4 Quarterly Reports / Deliverables C.10.4.1 Workload Statistics for the Main Clinic and EAP C.10.4.2 ECOMP Report C.10.4.3 Patient and Client Satisfaction Survey Report C.10.4.4 QC/QI Report C.10.4.5 Staffing Responsibilities Report C.10.5 Semiannual Report / Deliverable – Risk Management Report C.10.6 Annual Reports / Deliverables C.10.6.1 Procedure Manual Update C.10.6.2 Inventory of Electronic Equipment C.10.6.3 Capital Improvement Plan C.10.6.4 Referral Lists for Community Healthcare Providers C.10.6.5 Financial Reports C.10.7 Other Reports / Deliverables on an As-Required Basis

ARTICLE C.11 Government Furnished Property and Services C.11.1 Facilities and Furnishings C.11.2 Medical Equipment C.11.3 Pharmaceutical and Medical Supplies C.11.4 Office Supplies and Equipment C.12.5 Services

ARTICLE C.12 Transition Plan (Phase-In and -Out of the Contract)

Acronyms

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1 Performance Work Statement

The Contractor shall independently and not as an agent of the Government, be required to furnish all necessary services, qualified personnel, management, supervision, material, equipment and facilities, not otherwise provided by the Government, as needed to perform a comprehensive occupational medical program for the NIH.

The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with Section C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2 Background

C.2.1 Introduction

OMS is a Branch of DOHS, within ORS. It is a well-developed and highly respected NIH support service that has been recognized by outside reviewers as a role model for the provision of work-related medical care. OMS’s mission is to enhance health and safety at the NIH by providing a variety of work-related medical and counseling services. OMS provides limited support services to non-NIH employees (see C.5.1).

The Contractor’s staff are required to become fully familiar with the elements of the program (see C.10.2.2) and cross-trained in sufficient numbers to perform the related duties at appropriate staffing levels, with minimal government oversight. The services offered by OMS have been tailored to address the varied and unusual needs of the NIH workforce.

The Contractor shall attract and retain workers who are detail oriented, function as a well-trained team, and are committed to providing outstanding clinical care with compassion and respect.

The long-term retention of competent staff is critical to the reliable provision of high quality, customized medical support for the NIH community.

C.2.2 Organization

The NIH is the nation’s primary federal agency for conducting and supporting medical research.

NIH scientists conduct a range of basic and clinical biomedical research activities in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. The 350-acre Bethesda campus is an enclosed, essentially self-contained community with its own hospital, police and fire departments, public works, and utility systems. As a community, the NIH encounters environmental, sociological, and occupational health matters like those found in small towns and on the campuses of major universities. The NIH is composed of 27 semi-autonomous Institutes and Centers (ICs) of varying size.

The DOHS 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 environment. The DOHS includes the Office of the Director and six components: 1) Safety Operations and Support Branch (SOSB); 2) Technical Assistance Branch (TAB); 3) Community Health Branch; 4) Biorisk Management Branch; 5) Safety Engineering Activity; and 6) OMS. OMS is an integral part of the DOHS. The various DOHS components work cooperatively to investigate and resolve a variety occupational safety and health issues.

C.2.3 Population

The OMS provides occupational medical services for approximately 17,800 NIH employees and other federal employees who work on campus or visit the NIH. Approximately 9,400 employees (53 percent of the NIH workforce) are located on the NIH campus in Bethesda, MD. The remaining approximate 8,400 employees are stationed in rental buildings in the same county (Montgomery County), at NIH satellite campuses in Maryland, Montana, and North Carolina, and at field stations throughout the country (source: NIH Census Data, June 2018) and abroad.

Large NIH satellite facilities in Maryland are located on the Bayview Campus in Baltimore, MD, within Ft. Detrick in Frederick, MD, and the NIH Animal Care Center in Poolesville, MD. The two large campuses remote from the greater DC metropolitan area are the Rocky Mountain Laboratories (RML) in Hamilton, MT, and the National Institute of Environmental Health and Sciences (NIEHS) facilities in Research Triangle Park (RTP), NC. In addition, NIH employees may be assigned to temporary tours at NIH partner institutions in the United States and abroad.

The NIH employee population is diverse, multi-cultural, multi-ethnic, and multi-national. For many NIH worker, English is a second language. The population is comprised of professional, scientific, administrative, technical, clerical, and blue-collar personnel. The workforce in each work location is comprised of federal employees and contract workers.

The occupational categories represented at the NIH include:

Researchers – microbiologists, chemists, health science administrators, specialized research technicians;

Healthcare providers – medical doctors, nurses, medical technicians, laboratory technicians;

Research support workers – animal caretakers, laundry workers;

Professional and administrative staff – executive, administrative, and budget officers;

information technology specialists, clerical staff, supply clerks;

Technical and trades workers – utility engineers, plant operators, plumbers, carpenters, electricians, HVAC technicians; and Emergency and Security staff – police, fire, and emergency rescue personnel.

C.2.4 NIH Satellite Campuses and Facilities Supported by OMS

C.2.4.1 Baltimore, Maryland http://www.ors.od.nih.gov/sr/dohs/aboutDOHS/Pages/safety_op_branch.aspx http://www.ors.od.nih.gov/sr/dohs/aboutDOHS/TAB/Pages/technical_branch.aspx http://www.ors.od.nih.gov/sr/dohs/aboutDOHS/Pages/community_branch.aspx http://www.ors.od.nih.gov/sr/dohs/OccupationalMedical/Pages/oms_main.aspx

The National Institute on Drug Abuse (NIDA), the National Institute on Aging (NIA), and the National Human Genome Research Institute are located in Baltimore at and near the Johns Hopkins Bayview Campus. There are approximately 1,200 NIH employees at this location including summer students, guest researchers, and facility personnel.

C.2.4.2 Frederick, Maryland

The National Institute of Allergy and Infectious Diseases (NIAID) occupies a portion of the Integrated Research Facility (IRF) at Fort Detrick, a partner of the National Interagency Biodefense Campus (NIBC). Currently, there are approximately 130 workers at the IRF- Frederick who conduct and support research, including animal-based studies, in biosafety level (BSL)-2 to BSL-4 laboratories. A medical imaging suite is integral to the high biocontainment space. The building also houses administrative offices and support spaces. About half of the local workforce have access to restricted high biocontainment.

C.2.4.3 Hamilton, Montana

The RML campus houses a range of NIAID laboratories where currently about 370 workers conduct and support non-clinical biomedical research, including animal-based and disease vector studies. Among about 30 buildings is another high biocontainment facility, the RML IRF, with BSL-2 to BSL-4 laboratories, associated animal quarters, administrative and support spaces. The laboratory environment outside of the RML IRF includes BSL-1 to BSL-3 spaces and support structures. Slightly less than half of the workforce has access to BSL-3 or -4 environment.

C.2.4.4 Research Triangle Park, North Carolina

The National Institute of Environmental Sciences (NIEHS) employs slightly more than 1,200 workers at the Research Triangle Park (RTP) campus with about 670 being federal employees, 200 fellows, and nearly 260 contract workers. They conduct bench, animal-, and human-based research.

C.2.4.5 Special Facilities

Laboratory Animal Facilities. Laboratory animal-based studies are an integral part of the NIH research portfolio across many ICs supported by the centralized program of the Division of Veterinary Resources (DVR). Laboratory animal facilities are found at all NIH campuses and many field stations. The NIH community expects strict adherence to the principles of animal care and use and maintaining full accreditation of all NIH animal-based research by the Association of Assessment and Accreditation of Laboratory Animal Care International (AAALAC). A critical role of OMS is to support NIH activities accredited by AAALAC. The support of AAALAC requires adherence to the Guide for the Care and Use of Animals, 8th edition, and Occupational Health and Safety in the Care and Use of Research Animals (National Research Council, 1997).

High Biocontainment Laboratories. Permission to conduct research on biological hazards and toxins categorized into certain high-risk groups hinges on meeting safety and security http://www.drugabuse.gov/ http://www.nia.nih.gov/ https://www.genome.gov/dir/ https://irp.nih.gov/about-us/research-campus-locations/bayview-campus https://irp.nih.gov/about-us/research-campus-locations/bayview-campus http://www.niaid.nih.gov/Pages/default.aspx https://www.niaid.nih.gov/about/integrated-research-facility https://www.niaid.nih.gov/about/rocky-mountain-overview https://www.orf.od.nih.gov/AboutORF/BFM/Pages/IRFRML.aspx https://www.niehs.nih.gov/about/visiting/index.cfm http://www.aaalac.org/ http://www.aaalac.org/resources/theguide.cfm http://www.nap.edu/openbook.php?record_id=4988&page=R1 requirements set forth by the NIH. Specific facility and procedural requirements for BSL-1 to BSL-4 laboratories and animal biological safety level (ABSL) 1 through ABSL-4 laboratories are outlined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th edition. NIH workers in the A/BSL-3 and -4 environment must be enrolled in the NIH Biological Surety Program (BSP, see C.5.3.3). The biological hazards contained in the BSL-4 laboratories are all select agents, and employees who have access to them must also be enrolled in the NIH Select Agent Program. NIH work with select agents requires full compliance with the Federal Select Agent Program as set forth by the Centers for Disease Control and Prevention/Division of Select Agents and Toxins (CDC/DSAT) and the United States Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS).

Clinical/Patient Care Facilities. The NIH’s research includes extensive research with human subjects. NIH activities involve patient and healthy volunteer activities in many locations, the largest being the NIH Clinical Center (CC) on the main NIH campus. This work is subject to strict regulatory requirements, and OMS provides critical support, including during accreditation of the CC by The Joint Commission (TJC).

ARTICLE C.3 OMS Offices and Hours of Operation

The OMS clinics and Employee Assistance Program (EAP) Office operate Monday through Friday and are closed on weekends and federal holidays. See C.8 for staffing levels for the clinics and EAP office.

C.3.1 Main Clinic

The Contractor shall operate OMS Main Clinic on the Bethesda campus. Its hours of operation are 7:30am to 5:00pm.

C.3.2 Satellite Clinics Locations

C.3.2.1 Baltimore, Maryland

The clinic is in the Gerontology Research Center. Its hours are 8:00am to 4:30pm.

C.3.2.2 Frederick, Maryland

The clinic is located on the Ft. Detrick campus. Its hours are 8:00am to 4:30pm.

C.3.2.3 Hamilton, Montana

The clinic is located on the Rocky Mountain Laboratory campus. Its hours are 7:30am to 4:00pm.

C.3.2.4 Research Triangle Park, North Carolina

The clinic is located on the NIEHS campus. Its hours are 8:00am to 4:30pm.

http://www.cdc.gov/biosafety/publications/bmbl5/ https://www.ors.od.nih.gov/sr/dohs/safety/laboratory/BioSafety/Pages/select_agents.aspx https://www.selectagents.gov/ http://www.jointcommission.org/ http://www.ors.od.nih.gov/sr/dohs/EAP/Pages/index.aspx

C.3.3 EAP Office

The EAP Office is located on the Bethesda campus. Its hours are 8:00am to 5:00pm Monday through Thursday and 8:00am through 4:00pm Friday.

C.3.4 Intermittent OMS Locations

The Contractor is required to offer the OMS annual mass influenza immunization program and EAP services in off-campus facilities, upon request by the Technical Representative (TR), in consultation with the COR (see C.5.2.3 and C.5.6).

The Contractor shall not alter the services or hours of operation of OMS clinics or the EAP Office, when providing services at intermittent OMS locations.

ARTICLE C.4 OMS Staffing

C.4.1 Staffing during Routine Office Hours

The Contractor is required to staff OMS offices during the hours of operation (see C.3).

The Contractor is required to ensure that its patients and EAP clients receive routine, urgent and emergency care in a timely fashion (see C.5.2, C.5.2.1, C.5.2,3, C,5.3.3, C.5.4, C.5.4.1, C.5.4.2, 5.6.2, and 5.6.6).

C.4.2 Staffing after Routine Office Hours

The Contractor is required to provide on-call support (see C.5.4.2), after routine clinic hours, by one mid-level medical provider (i.e., Nurse Practitioner [NP] or Physician Assistant [PA]).

These mid-level medical providers, in association with the federal physicians, provide medical advice for occupational exposures to potentially life-threatening biological hazards (see C.5.3.3 and C.5.4.2).

C.4.3 Government Adjustments to Staffing

When the government reduces staffing (e.g., furlough, early dismissal for holidays, etc.,), the Contractor is required to staff:

• The Main Clinic with a minimum of one mid-level medical provider, a registered nurse (RN), and an administrator;

• The Frederick and Hamilton clinics with a RN or a mid-level medical provider; and

• The EAP office with one senior counselor.

Upon request of the COR, the Contractor shall adjust the hours of operation at any one or all OMS facilities or the hours of any labor category on this contract.

C.4.4 Contractor Requests to Adjust Staffing

The Contractor shall request staffing adjustments, when the Contractor anticipates reductions in demands for services (e.g., holiday periods) or increases in demand (e.g., processing summer hires, influenza immunization program, etc.,). The TR must approve in advance any adjustment in staffing or hours of operation for the main or satellite clinics proposed by the Contractor. The intent of this provision is to minimize over- or under-staffing when the Contractor recognizes the potential for the workload to be other than the norm.

ARTICLE C.5 Clinical Care Elements

Each year, approximately 41,200 outpatient visits for medical care at the various OMS clinics.

The OMS Procedure Manual (see C.6.1) contains of 95 standard operating procedures that describe in detail the services OMS provides for the NIH community. This section provides an overview of some of those services.

The Contractor’s staff are required to protect worker’s personally identifying information (PII) and personal health information (PHI) in the records they maintain and in their communications with others (see C.6.7).

The Contractor’s staff shall treat all records, both hard copy and electronic, as medically confidential, and shall maintain the necessary security for the records (see C.6.7).

The Contractor’s staff shall provide care that conforms with the description of the service in the relevant OMS procedure (see C.6.1 and C.10.2.2).

The Contractor shall conduct email surveys of patients evaluated in OMS clinics throughout the year. The surveys shall assess the timeliness and effectiveness of the service provided, as well as whether patients were treated with respect by the Contractor’s staff.

The contractor shall survey all EAP clients to assess their satisfaction and the extent of their stress at work during the intake assessment and three months after starting counseling.

The Contractor shall include a summary of the survey results for both OMS patients and EAP clients in each quarterly report (see C.10.4.3), maintain surveys for at least up to one month after the end of the quarter in which they were received, and make them available to the TR upon request for performance monitoring purposes.

The Contractor shall develop and maintain a referral list of community-based healthcare providers and ambulatory clinics for each OMS clinic location that can be offered to interested workers. The referral list shall include community practices that accept payment through the Federal Workers’ Compensation Program. The community healthcare resources suggested by Contractor’s staff shall be matched to the employee’s circumstances, location, and insurance coverage. Neither the Contractor nor its staff shall have any personal or financial affiliation with community-based resources shared with OMS visitors. The Contractor shall update the list for each OMS clinic location at least every year (see C.10.6.4).

C.5.1 Care for Non-Federal Employees

The Contractor is restricted from extending OMS coverage to non-federal employees. However, there are several exceptions to this general rule:

1. OMS provides medical support for anyone who develops a medical emergency while on NIH grounds.

2. All work-related injuries that occur in NIH-operated buildings must be reported to the OMS, unless otherwise specified in a contract agreement. OMS staff members record the circumstances of the injury for all occupational injuries and illnesses reported by contractors. If the injury is reported within 24 hours of its occurrence, OMS also provides initial care for the injury.

3. OMS staff provide initial and follow-up medical support for injuries that involve a potential exposure to a hazard that could not readily be treated in the community or is of special interest to the NIH. Examples of these hazards include: the human immunodeficiency virus (HIV-1), Macacine herpesvirus 1 (B virus), biological hazards studied in BSL/ABSL-3 and -4 laboratories, and some radioisotopes.

4. OMS staff provide all relevant medical and EAP services to non-federal employees enrolled in the BSP (see C.5.3.3).

5. OMS offers the annual influenza vaccine to non-federal employees at NIH facilities.

C.5.2 Non-Urgent Medical Care Provided by Appointment

The Contractor shall assure that the median wait time for an appointment for routine medical care (for example preplacement medical evaluations, immunizations, surveillance and cohort evaluations, etc.,) shall not exceed ten minutes from the individual’s arrival in an OMS clinic.

C.5.2.1 Preplacement Medical Evaluations

The purpose of a preplacement medical evaluation is to determine an individual’s medical readiness to perform designated work. OMS staff perform approximately 1,200 initial preplacement medical evaluations for full-time employees and another 600 for summer hires each year. With required follow-up appointments to such as immunization or testing, these evaluations require approximately 2,500 visits to OMS annually. Typically, summer hires visit OMS in April, May and June and add significantly to work demands during those months.

The Contractor shall offer a preplacement medical evaluation within five workdays of the request and within two workdays for an urgent request.

The Contractor’s personnel are required to have a detailed appreciation of services provided by OMS and who is eligible to receive them, in order to tailor the preplacement medical evaluation to the worker’s individual needs.

The Contractor’s staff are required to counsel and enroll employees in relevant cohort procedures for employees, based on their work responsibilities and potential health hazards in their workplaces.

C.5.2.2 Immunizations

OMS clinics provide approximately 1,000 immunizations, excluding flu vaccine, each year. The immunizations currently provided include: 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; typhoid; vaccinia virus;

varicella-zoster virus; pneumococcal; yellow fever virus; and an Ebola virus (provided as part of a phase 2 clinical research trial).

The Contractor shall provide these immunizations and potentially others.

The Contractor shall recall workers for booster doses and identify workers who fail to comply with recommendations to receive a vaccine required for work with a biological hazard (e.g., rabies, vaccinia vaccines) and nonhuman primates.

C.5.2.3 Influenza Immunization Program

The Influenza Immunization Program accounts for more patient contacts (approximately 15,000) than any other OMS offering and is completed in approximately six weeks. The vaccine is provided on the main campus in Bethesda and five other off-campus locations in Montgomery County, MD as well as at each of the satellite clinics and Harbor Hospital in Baltimore, MD.

The Contractor shall provide this service without significantly altering the services offered by, or staffing for, the Main or satellite clinics and the median wait time shall not exceed five minutes and no more than two percent of vaccine recipients should wait twenty minutes or longer.

Clinical Center (CC) management requires that the approximately 3,200 workers who have face-to-face contact with patients (i.e., healthcare workers [HCWs]) receive the seasonal influenza vaccine each year.

The Contractor, working with IT support, shall inform CC management in a timely manner whether or not identified HCWs have complied with the mandate to receive the vaccine or formally decline it.

C.5.2.4 Support for Investigational New Drug Research Studies

OMS participates in research studies involving Investigational New Drugs (IND) such as an Ebola vaccine. The Medical Director is an Associate Investigator. Currently, OMS records approximately thirty study-related visits annually.

The Contractor shall provide a nurse to serve as the Study Coordinator. The Study Coordinator provides coordination and day-to-day management for this study and reporting to an Institute’s Institutional Review Board (IRB).

In addition, OMS may develop additional studies involving INDs as a means of enhancing the safety and protection of NIH researchers.

The Contractor’s Study Coordinator shall be responsible for managing the program, ensuring the safety and wellbeing of the participants, anticipating and adhering to all protocols and regulatory requirements, and administering immunizations and related services, and tracking study subjects.

C.5.2.5 Support for International Travelers

Each year, OMS processes approximately 350 requests for pre-travel medical support for work-related international travel.

The Contractor shall assure that the medical care and advice provided is current, complete, and timely.

Rarely, as in the Ebola epidemic in West Africa, the NIH sends a large number of researchers and clinicians to assist in the investigation and stabilization of international epidemics.

C.5.2.6 Physical Therapy

Approximately 150 NIH employees with work-related injuries and illnesses are referred to the OMS physical therapist Each year and they account for approximately 650 visits to OMS annually. The OMS physical therapist provides approximately 25 trainings a year to the CC Nursing Department and other NIH work groups regarding proper body mechanics to avoid occupational injuries and illnesses. The OMS physical therapist also performs approximately 100 ergonomic assessments and related reports of NIH workstations in the CC each year.

Finally, the physical therapist serves on NIH committees that review occupational injuries and illnesses reported to OMS and develops strategies to prevent them.

The Contractor is required to provide physical therapy services in the Main Clinic. Physical therapy services shall be offered only to federal employees with work-related injuries or illnesses that are receiving care from the Contractor’s clinicians. The number of visits for any occupational injury or illness shall be limited to six. If it is apparent to the physical therapist that the worker will require more than six visits, the physical therapist shall offer the worker community-based healthcare providers for further care (see C.5).

In addition to providing clinical care, the Contractor’s physical therapist shall provide the training and ergonomic assessments and participate on committees, as outlined above.

C.5.2.7 Acupuncture

The Contractor may be required to provide acupuncture services in the Main Clinic. Access and the duration of care shall be limited as described above for physical therapy services.

Approximately 80 workers are referred to the Contractor’s acupuncturists and they account for approximately 150 visits to OMS each year.

C.5.2.8 Contact Studies

OMS offers medical counseling, testing, and potentially treatment for possible occupational exposure to a variety of biologic hazards (e.g., M. tuberculosis, hepatitis A, varicella, scabies, etc.). Collectively, contact studies account for approximately 150 visits to OMS each year.

The Contractor shall provide this support and a summary statement for each contact study. This information is shared with the CC Hospital Epidemiology Service (HES), when the suspected exposure occurs in the CC.

C.5.2.9 Reviews of Medical Records

NIH employees who cite a medical condition as a justification for proposed accommodations (i.e., modification of work responsibilities or the use of leave) may submit medical information to support their requests. Annually, OMS processes 200 requests for short-term disability, including applications for Family and Medical Leave (FML), premium class travel accommodations, handicapped parking, and extension of healthcare benefits. OMS staff also reviews 25 applications for medical disability retirement benefits.

The Contractor’s personnel shall provide support for medical reviews. At a minimum, this support shall consist of:

Responding to inquiries from the employee, supervisor, the Office of Equity, Diversity, and Inclusion (EDI), and the Office of Human Resources (OHR) Employee Relations Specialists regarding the process;

Receiving and expeditiously processing requests from management and records from employees;

Notifying management when employees do not submit medical records by a defined deadline;

Organizing medical records and drafting medical reviews for OMS physicians, to expedite the review process; and

Distributing completed reviews and filing related paperwork.

C.5.2.10 Laboratory Support Services

OMS provides laboratory support services approximately 1,100 times each year. Examples of these services include: phlebotomy, blood chemistries, hematology studies, urine analysis, serologies, viral cultures, and serum storage. The testing is performed both at NIH and community-based laboratories.

The Contractor shall provide at each OMS clinic: phlebotomy services, processing of body fluids for laboratory testing, performing CLIA-waived tests, serum storage, shipping and receiving body fluids for specialized testing at facilities in other states, and tracking and recording laboratory test results.

The Contractor shall store serum specimens in -20ºF, non-frost-free freezers in Maryland and Montana. The freezers in Maryland are managed by a commercial repository (see C.5.5.4 and C.9.1.6).

C.5.2.11 Other

The Contractor shall provide a variety of other work-related medical services as defined in the OMS Procedure Manual (see C.56.1). For example, the Contractor shall provide initial medical clearances for participants who are expected to use N-95 respirators and Powered Air-Purifying Respirators (PAPRs) and coordinate their work with DOHS to ensure compliance with the Occupational Safety and Health Administration (OSHA) regulatory requirements. There are approximately 60 such visits per year. See the OMS Procedure Manual for a listing of services offered to the NIH community.

C.5.3 Non-Urgent Care provided via Recurring Appointments

Participation in OMS Cohort Procedures usually is voluntary. However, employees who have contact with animals used in research or who have access to biological hazards handled in BSL/ABSL-3 or -4 laboratories are required to participate in the related cohort procedure.

The Contractor shall administer the following programs by alerting workers of their eligibility to participate, scheduling and recalling participants, and providing the service as described in the relevant procedure(s) (see C.56.1).

C.5.3.1 Animal Exposure Program

The Animal Exposure Program (AEP) provides health and safety information related to the use and care of animals, occupationally indicated immunizations, and clinical evaluation and treatment for animal-related injuries or illnesses. The AEP tailors the medical services offered to the types of animals with which the employee works: nonhuman primates, large animals, and small animals. The NIH requires all employees who have contact with animals or their living quarters, viable tissues, body fluids, or waste to participate in this program.

Currently, there are 6,400 participants in the AEP. Most AEP-related services are provided during preplacement and Tuberculosis Surveillance Program visits (see C.5.2.1 and C.5.3.6).

Approximately 450 additional visits are recorded annually specifically for AEP-related care.

The Contractor shall email AEP participants annually to remind them of recognized health hazards in their workplaces and the steps they must take should they sustain an occupational injury.

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=12716&p_table=standards http://oacu.od.nih.gov/exposure/index.htm

C.5.3.2 Asbestos Medical Surveillance Program

The Asbestos Medical Surveillance Program (AMSP) provides medical evaluation and counseling for employees who are suspected to have worked in areas with airborne asbestos.

Currently, there are approximately 90 participants in the AMSP and they account for approximately 20 visits to OMS annually. Approximately 20 chest radiographs are interpreted by a B reader each year. On average, once every three years a participant in this program is referred to a community-based pulmonologist for further evaluation when screening findings suggest asbestos-related lung disease.

The Contractor is required to provide a B reader for the evaluation of chest radiographs (see C.9.1.1).

The Contractor also shall provide a pulmonologist in Montgomery County, Maryland to perform an initial clinical evaluation, including diagnostic studies, for workers with potential evidence of asbestos related lung disease (see C.9.1.2).

C.5.3.3 Biological Surety Program

The BSP is designed as an overarching service for individuals who work in BSL/ABSL-3 or 4 laboratories or have unrestricted access to either the biological hazards 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 or -4 laboratory environment.

Participants who have access to these biological hazards also receive services defined in pathogen-specific procedures during their enrollment and annual BSP visits. The NIH requires both federal employees and contractors who meet the criteria for this program to actively participate in it. The program, which is integrated with the Select Agent Program, requires extensive communication and coordination between the Contractor and other sections of the

DOHS.

Currently, there are approximately 600 participants in the BSP. Eighty percent of those workers are cleared to work in or in support of BSL/ABSL-3 laboratories. The rest are cleared to work in or in support of BSL/ABSL-4 laboratories. Collectively, they account for approximately 900 visits to OMS annually. 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.

The Contractor is required to provide a BSP-visit to program participants within eleven to thirteen months of their last routine BSP-visit.

The Contractor’s staff shall be familiar with the OMS pathogen-specific procedures designed to support for researchers working with a variety of human pathogens (e.g., B. anthracis, B. mallei and pseudomallei, C. burnetii, flaviviruses, hemorrhagic fever viruses, highly pathogenic influenza viruses, Newcastle disease virus, orthopox viruses, and corona viruses) and provide the related counseling.

http://www.ors.od.nih.gov/sr/dohs/healthandsafety/ih/asbestos/pages/workplace_asbestos.aspx

The Contractor’s staff shall participate in approximately three BSP-related drills annually for NIH BSL/ABSL-3 and -4 laboratories in Bethesda and Frederick, Maryland and Montana.

C.5.3.4 Hearing Conservation Program

The Hearing Conservation Program provides medical monitoring for employees who may be exposed at work to noise levels at or exceeding threshold limits values for noise exposure in accordance with standards of the Occupational Safety and Health Administration (OSHA).

Currently, there are about 400 employees in the Hearing Conservation Program resulting in about 350 visits to OMS annually.

The Contractor shall monitor employees for health effects from noise exposure and provides related counseling and literature.

C.5.3.5 Police Officers and Firefighters Evaluations

OMS provides approximately 30 medical evaluations for police officers and firefighters each year, including preplacement and annual evaluations. Currently, approximately 15 firefighters and 10 police officers receive annual evaluations.

The Contractor shall provide preplacement medical evaluations for police officers and firefighters that are more detailed than preplacement evaluations for most other workers at the NIH. Firefighters receive similar, annual medical evaluations.

In addition, the Contractor’s staff shall determine the medical readiness of a subset of police officers to participate in an intensive program of physical exercise as part of their proposed work on an emergency response team.

C.5.3.6 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 NIH. Currently, the TBSP has approximately 3,000 employees enrolled resulting in roughly 1,700 visits to OMS annually. About 800 TBSP participants are recalled for mandatory screening. Approximately 2,000 workers with low occupational exposure risk to TB are eligible to be tested once a year.

The Contractor’s staff shall perform TB testing and recall of TBSP participants as described in the TBSP and AEP (see C.6.1).

C.5.3.7 Other

The COR, in consultation with the TR, may direct the Contractor to plan and administer similar cohort procedures.

https://www.osha.gov/SLTC/noisehearingconservation/hearingprograms.html https://www.osha.gov/SLTC/noisehearingconservation/index.html http://www.ors.od.nih.gov/sr/dohs/occupationalmedical/pages/med_surveillance.aspx

C.5.4 Urgent Care Provided without Appointment

OMS staff respond to approximately 400 requests for urgent or emergent medical care annually.

The Contractor is required to provide immediate and appropriate clinical care for individuals seeking emergency medical care from an OMS clinic.

C.5.4.1 Occupational Injuries and Illnesses

All NIH workers (both federal and contract employees) are required to report their work-related injuries and illnesses to OMS. Each year, OMS records approximately 1,100 new occupational injuries and illnesses. Initial and follow-up medical evaluations of occupational injuries account for approximately 1,500 visits to OMS annually.

SOSB staff and the CC Safety Officer review occupational injury and illness data collected by OMS to identify the potential impact of recognized workplace hazardous and the possible effect of mitigation strategies. TAB staff publish the OSHA Form 300A of occupational injuries and illnesses each year. OMS generates and maintains the data for this and other OSHA reports.

Some occupational injures (for example a laceration, corneal abrasions, severe back pain) require urgent medical care. Other injuries (for example repetitive motion trauma, emotional stress) can be seen by appointment. If the injured worker arrives in OMS without appointment and his or her travel to OMS is time-consuming (for example relying on a shuttle to an off-campus location), the staff handle the report as though care is needed urgently.

The Contractor’s staff are required to provide urgent care within twenty minutes of a patient’s arrival in OMS and to offer an appointment within three workdays of receiving a request for non-urgent care.

The Contractor’s staff shall:

1. Record accurately the worker’s history of the accident and record it in both a clinical (paper) record and in an electronic medical record (see C.7.3.2). Once the transition to a tested and fully functional electronic medical record is completed new entries shall be made into the electronic application only (see C.6.7).

2. Perform a clinical evaluation and provide medical care. If the medical care that is needed exceeds the abilities of the Contractor’s personnel or the worker requests it, the Contractor’s personnel shall offer the injured worker qualified community-based healthcare providers for further care (see C.5).

3. Define the worker’s functional restrictions, if any, which result from the injury and their anticipated duration and communicate them to the supervisor.

4. Determine whether and when the worker should return to OMS for revaluation. Non-federal employees generally are not eligible for follow-up clinical care in OMS.

Occupational injuries and illnesses that qualify for emergency medical care (see C.5.1) constitute exceptions to this rule.

5. Direct injured workers to the Department of Labor (DOL) Employees' Compensation Operations and Management Portal (ECOMP) to receive the appropriate Office of Workers' Compensation Programs (OWCP) claim forms and related guidance. The NIH Human Resources Office assists federal workers with the process for submitting claims for Workers’ Compensation at the NIH. Non-federal workers receive Workers’ Compensation forms and assistance through their employer.

6. Record the relevant OSHA data in each occupational injury or illness clinical record entry and serve as the NIH OSHA Records Keeper (ORK, see C.6.8).

7. Communicate with a SOSB or the CC Safety Specialist to minimize the risk that other workers will be injured in a similar fashion.

8. Review ECOMP data weekly and make certain that the OMS injury database includes all occupational injuries and illnesses recorded in ECOMP by NIH employees (see C.6.8 and C.10.4.2).

9. Notify the TAB Branch Chief immediately of any work-related injury that results in either the hospitalization or death of an injured worker.

C.5.4.2 Occupational Injuries and Illness Emergencies Occurring After Clinic Hours

OMS provides after clinic-hours (i.e., on-call) medical support for injuries that may involve exposure to serious biological hazards (e.g., human or animal body fluids, HIV-1, B virus, BSL/ABSL-3 or -4 agents) and radioisotopes. OMS receives approximately 100 calls for assistance after clinic hours each year. Of these requests, approximately half do not meet the criteria for after-hours emergency care. The NIH Page Operator contacts the on-call medical provider to request assistance.

The Contractor is required to provide on-call coverage (first call) with medical providers for incidents possibly involving high-consequence pathogens, other hazards, or serious injuries after routine clinic hours, on seven days a week basis.

The Contractor’s on-call provider shall respond to NIH requests for after-hours support within 15 minutes of receiving a page and consult with the on-call physician, as needed.

The Contractor’s on-call provider shall notify promptly the TAB representative of any work-related injuries or illnesses that results in the hospitalization or death of a worker.

OMS physicians (federal or contractor) provide back-up coverage (second call). Federal clinicians may share in first call coverage with advance notification by the Contractor, if the need arises. The on-call OMS physician assumes clinical responsibility for incidents that involve a potential exposure to a biological hazard in BSL/ABSL-3 or -4 laboratories.

C.5.4.3 Return to Work Assessments

OMS performs approximately 450 return to work assessments each year.

https://www.ecomp.dol.gov/ https://www.ecomp.dol.gov/ http://www.dol.gov/owcp/dfec/regs/compliance/forms.htm http://www.dol.gov/owcp/dfec/regs/compliance/forms.htm https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=9638&p_table=STANDARDS

The Contractor’s personnel shall examine any documentation the employee provides, obtain a related medical history, and determine whether there was a medical basis for the absence or proposed functional restrictions.

The Contractor’s staff shall notify the supervisor that insufficient information was provided to justify the absence or proposed restrictions, if the documentation and employee’s history do not adequately explain the medical basis for the absence.

C.5.4.4 Emergency Medical Support

Emergency medical support within Building 10, including the OMS Main Clinic, is provided by the CC Code Team. The Division of Fire and Rescue Services (DFRS) provides similar support for the remainder of the NIH main campus.

Approximately 100 times a year the OMS Main Clinic staff are called upon to provide emergency medical support. Examples of the clinical bases for the requests include: chest pain, poorly controlled asthma, seizures, depression with suicidal ideation, acute psychosis, mania, paranoid ideation, potential exposures to infectious agents and radioisotopes. The CC Code Team may be summoned for assistance with life-threatening, unstable medical conditions. The NIH Rescue Squad provides transport ill workers to community emergency departments, as needed.

The Contractor’s staff shall provide emergency diagnosis, appropriate first aid, and additional treatment for injuries and illnesses that result from exposures to hazardous materials in NIH workplaces.

The Contractor’s staff shall transfer patients with urgent and emergent medical needs, when their needs exceed what can reasonably be expected to be available in OMS. Transfers shall occur without undue delay and be directed to an appropriate community medical provider for further care.

The Contractor’s staff shall recognize and effectively and efficiently refer substance abuse induced medical emergencies for treatment. The Contractor’s staff shall use a breathalyzer, as clinically indicated. The Contractor’s staff are not be expected to diagnose or test for other forms of chemical impairment.

The Contractor shall ensure that an EAP counselor assists workers return to work, as clinically indicated.

C.5.4.5 Medical Care for Non-Occupational Injuries or Illnesses

OMS personnel triage approximately 2,250 requests for evaluation of personal medical issues each year. Individuals with medical emergencies receive care immediately. Individuals with non-emergent, non-work-related medical issues are referred to their personal healthcare provider.

If they do not have a personal healthcare provider, they are offered referrals to healthcare providers in the community (see C.5).

The Contractor’s staff shall provide 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.

C.5.5 Community-Based Medical and Other Services

The following work-related medical services shall be provided by community-based clinicians and specialized resources.

C.5.5.1 Safety Eyeglass Program

Each year, OMS provides an average of thirty pairs of prescription safety eyeglasses for NIH employees in Maryland and another five for employees in Montana. NIH employees seeking prescription safety eyeglasses must provide a current prescription (not more than one year old).

The Contractor shall provide community-based work-related optometric services for NIH employees in Maryland, Montana, and North Carolina.

The services shall include measuring, fitting, and repairing safety eyeglasses; and furnishing new lenses, frames, and glass cases when required for prescription safety glasses.

The specifications for the safety eyeglasses are as follows:

1.…