Attachment 1 - Performance work Statement - Clinical Support Services.doc

Performance Work Statement (PWS)

Project:

Clinical Support Services for

Human Studies Projects - WHNRC Davis, CA

GENERAL INFORMATION

1.0 Background and Purpose:

Western Human Nutrition Center (WHNRC) is a Center within the Agricultural Research Service (ARS), an agency within the U.S. Department of Agriculture and is responsible for high quality nutrition studies that inform policy makers and the general public. WHNRC administers research studies focused on the effects of the Dietary Guidelines for Americans on prevention of obesity, chronic disease, and inflammation, and on nutritional status. Research study protocols are reviewed and approved by the UC Davis Institutional Review Board.

Congress mandated that the WHNRC, ARS, of the USDA, situated on the Campus of UC Davis, conduct research into human nutritional requirements and on nutritional status, surveillance, intervention, and monitoring. This includes research that pertains to: (a) nutritional requirements, (b) nutritional status evaluation methodology, (c) nutrient intake methodology, (d) coordination of survey and nutrition status methodologies, and (e) methodologies to assess the effect of nutritional intervention programs and the conduct of field operations in nutrition status monitoring.

The research program at WHNRC falls under one objective of the ARS strategic program plan, which addresses five over-arching components:

1. Linking Agricultural Practices and Beneficial Health Outcomes

2. Monitoring Food Composition and Nutrient Intake of the Nation 3. Scientific Basis for Dietary Guidance

3. Prevention of Obesity and Obesity-Related Diseases

4. Life Stage Nutrition and Metabolism

To accomplish the objectives of this mission, the WHNRC must conduct human experimentation. This is done within a Metabolic Research Unit (MRU) and free-living studies. The purpose of the WHNRC is to develop new knowledge in nutrition as well as to develop effective and efficient methods for assessing nutritional status in human subjects. This is accomplished by conducting metabolic studies on resident subjects and controlled research experimentation on non-resident (free-living) subjects. The MRU is capable of handling 12 resident human volunteers plus a variable number of non-resident human volunteers (depending on the complexity of the protocols). The MRU covers approximately 3,300 square feet. There are 12 subject rooms that accommodate a bed in each for a total of twelve residential subjects. In addition, there are two storage closets, a nurses' station, physical exam room, specimen collection room, quiet room, and a living room-dining room.

USDA intends to award a Firm Fixed Priced contract for commercial non-personal clinical support services. The contract period of performance will be for one (1) base year, and three (3) option years. The Unit of Measure (UOM) for each service CLIN will be weeks (WK). Clinical nursing assistant services will be performed for a total of 26 weeks during each period of performance.

2.0 Definitions:

2.0 Acceptance: Constitutes acknowledgement that the supplies or services conform to the applicable contract quality and quantity requirements, except as provided in FAR subpart 46.5 and subject to other terms and conditions of the contract.

2.1 Approval: Acknowledgment by the designated Government official that submittals, deliverables, or administrative documents (e.g., insurance certificates, installation schedules, planned utility interruptions, etc.) conform to the contractual requirements. Government approval does not relieve the Contractor from responsibility for compliance with contract requirements.

2.2 ARS- The Agricultural Research Service (ARS) is the U.S. Department of Agriculture's chief scientific in-house research agency. Our job is finding solutions to agricultural problems that affect Americans every day from field to table.

2.3 Business Associate: Any company or person that is exposed to, handles, or works with the data in medical records is a "Business Associate" of the medical entities they work for.

2.4 Business Associate Agreement {BAA): A business associate agreement (BAA) is a contract between a HIPAA-covered entity and a HIPAA business associate (BA). The contract protects personal health information (PHI) in accordance with HIPAA guidelines.

2.5 Code of Ethics: The Revised American Nurses Association Code of Ethics and Standards of Practice and Care, published in 1996 by the American Nurses Association which makes explicit primary goals, values and obligations of the nursing profession.

2.6 Contracting Officer {CO): A Government employee with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.7 Contractor: The individual awarded a legal binding contract to provide supplies and services.

2.8 Contracting Officer's Representative (COR): A federal employee who assists the ordering/issuing activity contracting officer in the administration of task orders issued under this contract. The COR is primarily responsible for the technical assistance and day-to-day program management of the ordering activity's task orders. Ordering activities may have different designators for this employee (e.g., COR- contracting Officer's Representative or GTR-Government Technical Representative,).

2.8 Contractor Performance Assessment Report: A report that assesses a contractor's performance and provides a record, both positive and negative, on a given contract for specific period of time.

2.9 Cooperative Attitude: Behavior that is positive and displays a willingness to perform assigned patient care tasks and to be a team player.

2.10 Cultural Awareness: Realization and respect for diverse cultures given the recruiting goals of the scientific studies.

2.11 Customer: Research Subjects, staff, and visitors of the WHRNC.

2.12 Customer Evaluation/Input: Written comments made to the Contracting Officer regarding the Contractors performance. This is one of the criteria used to evaluate the Contractor's performance.

2.13 Dependability: Qualities of being trusted and being able to repeat the same task to yield the same result.

2.14 Federal Acquisition Regulation (FAR): The FAR is the primary regulation for use by all Federal Executive agencies in their acquisition of supplies and services with appropriated funds.

2.15 Federal Tort Claims Act (FTCA): The Federal Tort Claims Act (FTCA) is the waiver of sovereign immunity by the United States and provides the exclusive remedy for personal injury, death, and property damages resulting from the negligence of federal employees.

2.16 Government Vehicle: An ARS owned motor vehicle or a vehicle leased by ARS through agreements with the General Services Administration (GSA) or through commercial rental agreements.

2.17 Center: A facility physically separated from a hospital, that is open at least 40 hours a week for human research.

2.18 Health Insurance Portability and Accountability Act (HIPAA): A US law designed to provide privacy standards to protect patients' medical records and other health information provided to health plans, doctors, hospitals, and other health care providers.

2.19 Non-Personal Service Contracts: means a contract under which the personnel rendering the services are not subject, either by the contract's terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees as defined in FAR 37.

2.20 Ordering Activity: An authorized user of WHRNC that may issue a task order to obtain required services under this contract.

2.21 Ordering Activity Contracting Officer: A Government employee of ARS authorized and warranted to issue task orders and to make subsequent task order modification(s) under this contract. The Ordering Activity CO has the authority to make initial determinations on all matters of dispute regarding task orders.

2.22 Orientation: An activity designed to provide basic familiarization of the facility and transition the nurse into the ARS Service Unit and/or Health Center and the nursing unit where the services will be provided.

2.23 Past Performance Information: Relevant information regarding a contractor's actions under previously awarded contracts. This includes the contractor's record of conformance to specifications and to standards of good workmanship; the contractor's record of containing and forecasting costs on any previously performed cost reimbursable contracts; the contractor's adherence to contract schedules, including the administrative aspects of performance; the contractor's history for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor's business-like concern for the interest of the customer.

2.24 Patient Outcome: End result of nursing care.

2.25 Performance Work Statement Matrix: lists the services to be monitored and the standards to be applied.

2.26 Personal Protective Equipment (PPE): The equipment used to protect medical personnel from exposure to biological, chemical, and radioactive hazards.

2.27 Principal Investigator (PI) refers to the person(s) in charge of a clinical trial or a scientific research grant. The principal investigator prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant.

2.28 Quality Assurance Surveillance Plan (QASP): A written document prepared and used by the government for Quality Assurance surveillance of the contractor's performance.

2.29 Quality Control Plan (QCP): Those actions taken by the Contractor to control the quality of services provided. The Contractor's QCP must be equivalent to the Government's Quality Assurance plan.

2.30 Research Leader: The research leader is the local leader of a research unit as defined by the USDA’s Agricultural Research service (ARS).

2.31 Service Unit: The local administrative unit of ARS

2.32 Standards of Practice and Standards of Care: Authoritative statements by which the nursing profession describes the responsibilities for which its practitioners are accountable. The standards provide direction for professional nursing practice and a framework for the evaluation of practice. The standards of professional nursing practice may pertain to general or specialty practice.

2.33 Technical Direction: A directive to the Contractor that approves approaches, solutions, designs, or refinements; fills in details or otherwise completes the general description of work or documentation items; shifts emphasis among work areas or tasks; or furnishes similar instruction to the Contractor. Technical direction includes requiring studies and pursuit of certain lines of inquiry regarding matters within the general tasks and requirements in Section 5 of this contract.

2.33 Tour of Duty: The time of day the nurse or medical personnel is scheduled to perform nursing care duties; also considered the shift of the day. The time can vary according to the needs of each facility and/or clinic, e.g., 12-hour Tour of Duty, 8-hour Tour of Duty, 10-hour Tour of Duty. Includes weekends and holidays.

2.34 Valid Research Subject Complaint: Justifiable accusation made by a research subject and supported by investigation.

2.35 Verifiable Emergency: An unexpected/unplanned absence by the contractor requiring valid documentation to confirm the occurrence.

2.36 Laboratory Equipment: Items of specialized equipment used by scientists, researchers, and their assistants conducting scientific experiments and medical procedures in the laboratory and other controlled areas.

2.37 Formula Diet: A diet, usually consisting of a liquid blend of nutrient and non-nutrient components, that is used when a protocol demands nutrient controls which are unattainable with the use of conventional foods.

2.38 Hazardous Material: Material that is toxic, poisonous, corrosive, irritating, sensitizing, radioactive, biologically infectious, explosive, or flammable and that presents a hazard to human and animal health and the environment. Special handling procedures and disposal facilities are required to comply with federal, state, and local regulations.

CONTRACTOR REQUIREMENTS

3.0 SCOPE OF WORK:

3.1 WHNRC, which is located on the campus of the University of Davis, California, requires clinical research support services for human studies in which subjects are housed within the Center (Domiciled). Except those specified as Government-furnished, the Contractor shall provide all labor, supervision, principal tools/equipment, and materials, to furnish research and administrative support services for the USDA, ARS, Western Human Nutrition Research Center.

3.2 Clinical nursing assistant services will be performed for a total of 26 weeks during each period of performance. Each clinical trial runs for a duration of 2 weeks. The contractor shall provide clinical support services from Certified Nursing Assistants (CNA) who will manage human subjects during the testing cycles. The contractor shall determine proper distribution of their staff and manage/supervise the schedules and operations of their contractor personnel during each human study cycle.

3.3. Each human testing cycle will last 2 weeks. Contractor clinical support services shall provide coverage for seven (7) days of 12-hour night shifts; and two(2) weekend days of 12-hour day shifts as follows:

TO FRIDAY

HOURS PER YEAR

OPT 1

HOURS PER YEAR

OPT 2

HOURS PER YEAR

7:00am 7:00pm

7:00am 7:00pm

7:00am

CNA –weekend dayshift

7:00AM

7:00PM

7:00AM

7:00PM

On-site manager –weekend dayshift

7:00AM

7:00PM

7:00AM

7:00PM

7:00am 7:00pm

7:00am 7:00pm

7:00am

4.0 TECHNICAL REQUIREMENTS/TASKS:

4.1 The CNA contractor support shall provide a variety of health care and social services for both residential and non-resident study participants. Contractor personnel shall be licensed in the state of California, CPR certified, and able to operate a motor vehicle with DMV Class C license. The contractor will provide basic clinical care for research subjects under supervision per the approved research protocol.

4.2 The support services will include, but are not limited to, the assurance of the research subjects' health and safety, performance of procedures outlined by study protocols, dispensing medications, research meals and/or dietary supplements, charting and documentation, consultations with PIs, ordering and storing medical and nonmedical supplies, physical and social assessments of candidates, and planning and coordination of social/physical activities for residential subjects. The Contractor shall be responsible for organizing the records for each study and submitting them to the PI weekly. Diet test periods are 2 weeks in length and all records should be submitted 1 week after completion of the Diet test period.

4.3 The resident nursing assistant tasks shall include but are not limited to the following:

a.

Monitor and chart notes on subjects' health problems using a narrative format.

b.

Observation of signs and symptoms of illness, reactions to treatments or medications, and subjects' general behavior or physical condition.

c.

Dispense medications and/or dietary supplements and take verbal/telephone orders from the physician.

d.

Collect and record subjects' vital signs and chart collected research data into subjects' permanent medical records e.

Perform routine blood and urine sample processing. Administer qualitative tests on subjects' daily urine samples f.

Maintain logbooks for transmission to PI or for other staff instructions between shifts, or for recording study protocol deviations and errors g.

Supervise subjects' consumption of water, meals, and snacks h.

Supervise recreational and social activities for resident subjects, escort subjects to off-site outings while safely operating Government issued vehicles.

i.

Outside activity with the study subjects such as daily walks, develop new activities, planning activities pertinent to age and sex of subjects, and monitoring subjects during activities.

j.

Prevent the introduction of contraband items into the research environment by performing routine room inspections k.

Remove contaminated waste from the MRU and wipe down surfaces to prepare equipment for special procedures.

4.4 During non-resident or free-living studies, subjects are free to go about their normal lives, except for days which require their presence at the Center for testing or evaluation. The clinical support services will not be needed during the day.

4.5 Additional training for work with Human studies will be necessary and defined by the Institutional Review Board.

5.0 Government Furnished:

5.1 Information: Government unique information related to this requirement, which is necessary for Contractor performance, will be made available to the Contractor. The Contracting Officer or designee will be the point of contact for identification of any required information to be supplied by the Government.

5.2 Joint Use by the Government and the Contractor: Except for the property and service listed in 3.3 and 4.0, the Government will provide, for joint use by the Government and the Contractor, all necessary equipment, supplies, and clinic space to perform the services under this contract.

5.3 Government Vehicle: If required by the position, authorization shall be in accordance with IHS Chapter 12, Section 13 Motor Vehicle Management.

5.4 Personal Protective Equipment (PPE). The Government will furnish the Contractor with appropriate PPE other than specified in paragraph 4 of the contract. The Government will be responsible for any repair, cleaning, and inventory required for the PPE. This does not include any type of uniform or laboratory coat.

5.5 ID Badge: The Government will provide facility specific contractor identification badges for each contractor. A minimum fee of $10.00 will be charged for lost or destroyed badges.

5.6 Access to the following amenities within the government facility will be provided to the contractor while on site : Office space for contractor staff, equipment and record storage space, and procedure manuals.

6.0 Travel:

None.

7.0 Security Requirements:

7.1 The Contractor shall provide all requested information necessary to perform background checks. The Contractor shall comply with the requirement to obtain security investigations. The Contractor shall work with the IHS to ensure that the pre-employment screening process includes the appropriate investigation questionnaires and forms to be completed. All completed forms will be reviewed by the Contractor and forwarded to the Government Personnel. The Contractor will be immediately removed from the position if at any time the investigation receives unfavorable adjudication, or, if other unfavorable information that would affect the investigation becomes known.

7.2 e-QIP: Required Background Investigation Information: Executive Orders 10450, 12968, and HSPD-12 require a background investigation as a condition of employment. This investigation will be processed utilizing the US Office of Personnel Management (OPM), Electronic Questionnaire for Investigation Processing (eQIP) system.

7.3 FINGERPRINT CARD- FBI FD-258 (provided by the Federal Government) Fingerprint MUST be cleared and approved prior to contract assignment. Contract assignment(s) are conditional on a cleared background check.

9.0 Performance Requirement Measures:

The successful offeror will be required to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.