PWS Clinical Research Associate.pdf

BAMC (MAR23)

PERFORMANCE WORK STATEMENT (PWS)

CLINICAL RESEARCH ASSOCIATE

BROOKE ARMY MEDICAL CENTER (BAMC)

PART 1

GENERAL INFORMATION

1 General: This is a personal services contract, as defined by Federal Acquisition Regulation (FAR) Subpart 37.104 and is intended to create an employer-employee relationship between the Government and the individual contract Health Care Providers (HCPs) only to the extent necessary for providing the health care services required under the contract. The performance of health care services by individual HCPs under a personal services contract are subject to day-to-day supervision and control by health care facility personnel comparable to that exercised over military and civil service HCPs engaged in comparable health care services.

Any personal injury claims alleging negligence by the individual HCPs within the scope of the HCP’s performance of the personal services contract shall be processed by Department of Defense (DoD) in the same manner as claims alleging negligence by DoD military or civil service HCPs. The contract does not create an employer-employee relationship between the Government and any corporation, partnership, business association or other party or legal entity with which the HCP may be associated. The authority for this contract is 10 United States Code 1089 and 10 United States Code 1091.

1.1 Description of Services/Introduction: The Contractor shall provide Clinical Research Associate in support of the Department of Radiology at the Brooke Army Medical Center (BAMC) at Joint Base San Antonio, located on Fort Sam Houston, TX. These positions have been designated as Emergency Essential Personnel and shall be required to report to work in accordance with (IAW) Medical Treatment Facility (MTF) policy. All contract personnel shall possess qualifications meeting or exceeding the currently recognized national standards as established by The Joint Commission (TJC), provide the highest consideration to patient dignity, and observe the precepts of the American Hospital Association’s “Bill of Rights for Patients.” Services provided under this contract shall be as comprehensive as Government-supplied facilities, equipment, and support services permit.

1.2 Background: BAMC, a 425-bed Academic Medical Center, is the DOD’s largest in-patient hospital and only Level I Trauma Center. BAMC is staffed by more than 8,000 Soldiers, Airmen, Sailors, Civilians, and contract personnel providing care to wounded Service Members and the San Antonio Community at-large. With an average of 1,500 cases per month, BAMC is the most robust and productive healthcare organization within the Military Health System (MHS). The mission of the Military Healthcare System (MHS) is to enhance our Nation’s security by ensuring the nation has a healthy military force capable of providing the full range of military operations, supported by a combat ready healthcare system sustaining the health of DoD beneficiaries. Health care services for eligible MHS beneficiaries are provided at MTFs, such as BAMC, which are located on or near military installations or posts.

Hospitals offer more complex, resource-intensive secondary care (e.g., inpatient care, surgery under anesthesia) and primary care at outpatient clinics inside and outside the hospital.

Medical Centers offer tertiary (sophisticated diagnosis/treatment of any ailment), secondary, and primary care, hospital services, preventive services, blood bank, and outpatient services.

In addition, Medical Centers offer graduate medical education programs for physicians and other training programs for nursing and ancillary personnel.

1.3 Scope: The Contractor shall provide personal service(s). The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property & Services. The Contractor shall perform to the standards and acceptable quality levels identified in this PWS and associated contract documents.

1.4 Objective(s): To provide expertise to support the successful execution of clinical trials from the protocol concept through the clinical study report, ensures completion of study deliverables, typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.), and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Serves as the research subject matter expert for clinical research trials to primary and associate investigators within San for Brooke Army Medical Center, JBSA-Fort Sam Houston, Texas. Supporting BAMC’s mission in providing high quality treatment planning, and high-quality treatments to active-duty soldiers, military retirees, and their dependents. The objective of this contract is to provide qualified contract personnel to fulfill a minimum of 100% of the shifts requested while maintaining a turnover rate that shall not exceed 20% in any 12-month period. The following contract requirements are required at a standard that enables the MTF to maintain a high-level of quality patient care:

(a) Clinical Research Associate in support of Department of Radiology/Radiation Oncology section

1.5 General Information

1.5.1 Quality Control Plan (QCP): This acquisition is for commercial services and will be performed using FAR Part 12. The Contractor’s existing quality assurance system shall be utilized in accordance with FAR 12.208.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within 30 calendar days after date of contract award (A.001).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within seven (7) calendar days. If the Government has provided comments, the Contractor shall then have seven (7) calendar days to submit a Final QCP. After receipt of the Final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than seven (7) calendar days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team.

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (e.g., timelines, deadlines, and goals).

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses.

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance.

(e) How the Contractor will ensure all keys issued will remain controlled items (Paragraph 1.7 Key Control).

(f) How the Contractor will inventory and track maintenance of all Government Provided Equipment/Materials.

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all Quality Control related documents for the life of the contract plus five (5) years.

1.5.1.1 The Contractor shall inform the COR of issues (or potential issues) that might affect the performance within 24 Hours of identifying those issues. Verbal reports shall be followed up by written reports within seven (7) calendar days (A.002).

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g., deliverables, submittals, etc.)

deadlines fall on a holiday, the closest workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal work week, unless otherwise directed by the KO. When a U.S.

federally recognized holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed below. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner, as well.

New Year’s Day, January 1st Martin Luther King, Jr.’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth, June 19th Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following. The Chief, Radiation Oncology shall establish the routine hours of the Radiation Oncology Clinic. Services may be scheduled between 6:00 am and 6:00 pm Monday through Friday, excluding legal federal holidays, depending on patient treatment schedules. Normal routine clinic hours are 7:00 a.m. to 4:00 p.m., Monday through Friday. The total regular duty hours worked shall not exceed 40 hours per week. Duty hours include a one-hour lunch period, which is not paid by the government.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0700 to 1600, Monday through Friday except for U.S. Holidays identified in paragraph 1.5.3.1 above, or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2 Government Facility Operating Hours: The Government facility operating hours are from 0001 to 2400, Sunday through Saturday (i.e., 24 hours per day, 7 days per week). The Government facility is open for recognized U.S. Holidays identified in paragraph 1.5.3.1 above, and to essential personnel during national emergencies, administrative closings, or similar Government directed facility closings, unless otherwise communicated by the KO or COR to the Contractor.

1.5.4.3 Contractor Support Hours: The Contractor shall be available to provide support Monday through Friday from 0730-1630 hours daily. The Department shall establish a schedule for contract personnel to perform services on various shifts, which range from 8-10 hours. Each shift shall include 60 minutes for lunch, which may vary depending on the section and/or specific shift assigned. Duty hours are expected to average 40 hours per week. In order to maintain access to systems, no contract personnel shall work less than five (5) shifts per month. Contract personnel shall not provide services at another institution within eight (8) hours of their scheduled shift. Unplanned or unannounced schedule changes may occur, based on necessity, and in concurrence of the Contractor.

When directed by the Government, contract personnel shall remain on-duty to complete patient treatment, where lack of continuity of care would otherwise jeopardize patient health.

This provision is not intended to apply to the time required to complete routine tasks (e.g., completion of paperwork or routine administrative tasks at the end of a shift) which are to be completed as part of the normal work schedule.

During times of low workload, the Department, in concurrence with the COR, may choose to either release contract personnel from a scheduled work shift or re-assign them within the MTF to perform same/similar services that are within their scope of practice.

The Government reserves the right to review and validate hours of service performed by contract personnel by any means necessary, which may include the implementation of sign-in/sign-out procedures, which shall be maintained within the designated area. These attendance logs are for the sole use of the Government to ensure compliance with hours claimed in service of this contract and shall not be provided to the Contractor for any reason or purpose. Under no circumstances shall the Government sign a Contractor’s timesheet. With the exception of pager and/or on-call services, only actual hours worked on-site shall be claimed by the Contractor for compensation.

1.5.4.3.1 Scheduled Absences: Contract personnel shall provide a notice of leave to both the Department and COR 5 days prior to any planned absences. The Contractor is not required to provide a back-up to perform services during appropriately schedules absences.

The Contractor shall not invoice for periods when contract personnel are not performing services.

1.5.4.3.2 Unscheduled Absences: In the event that contract personnel are suddenly unable to provide services on an assigned duty day, they shall notify both the Department and COR no later than 8 hours prior to their scheduled shift.

1.5.5 Telework: The Government shall not permit contract personnel to telework in support of this requirement, as on-site performance is necessary to meet the needs within this requirement, with the exception of pager and/or on-call services. In furtherance of Continuity of Operations Planning (COOP), a telework program may be enacted to ensure that the Government's mission-critical operations stay operational during times of national emergency or incidents of national significance. Telework services shall be at no additional cost to the Government.

1.5.6 Place of Performance: The work to be performed under this contract will be performed at BAMC, a government facility located at the Brooke Army Medical Center (BAMC) at Joint

Base San Antonio, located on Fort Sam Houston, TX, and BAMC-associated medical facilities located within a 40-mile radius.

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: The Contractor shall have an active security clearance at the Tier 1 level at proposal submission and shall maintain this level of security for the life of the contract.

The Tier 1 Investigation (T1), formerly National Agency Check and Inquiries (NACI), is the basic and minimum investigation required on all new Federal employees and many contractors. It consists of a national agency check with written inquiries and searches of records covering specific areas of an individual’s background within the previous five (5) years of submission. These inquiries are sent to current and past employers, schools attended, references, and local law enforcement authorities.

1.6.2 Contract Personnel Security Clearance Requirements: Contract personnel performing services under this contract must have an active T1 prior to the commencement of services and must maintain this level of security for the life of the contract. The Contractor shall coordinate and schedule all security requirements and appointments with the COR before contract personnel can provide services. The COR shall provide the Contractor with all required Security documentation, review all Security documentation submitted by the Contractor, and initiate the request for the contract personnel’s security action with the Security Manager. The Contractor is responsible for monitoring the coordination and completion of all Security requirements with the COR.

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings, and controlled areas. The Contractor shall ensure that any subcontract personnel used in performance of this contract complies with these requirements and that all contract personnel, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.6.3.1 Installation Pass Log: Reserved

1.6.3.2 Individual Termination or Expiration of Employment: The Contractor shall collect all outstanding installation access passes and Common Access Cards (CACs) the same day employment of any contract personnel has expired or has been terminated and shall return them to the COR within seven (7) calendar days (A.003).

1.6.3.3 Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and CACs and return them to the COR within seven (7) calendar days (A.004). Contract personnel that have agreed to continue providing services under the succeeding Contractor are exempted.

1.6.3.4 Common Access Cards (CACs): The Contractor shall provide the COR with any necessary information required to obtain a CAC or installation access card within seven (7) calendar days prior to contract personnel commencing servicers (A.005).

1.6.4 Background Checks: The Contractor shall consult with the COR applicable to the location(s) associated in this PWS, and identify the level of background check necessary, as supported by applicable regulation(s). The Contractor shall coordinate and schedule all background check requirements with the COR before contract personnel can provide services.

The COR shall provide the Contractor with all required documentation, review all documentation submitted by the Contractor, and initiate the request for the contract personnel’s background check with the Security Manager and Provost Marshals Office (PMO).

The Contractor is responsible for monitoring the coordination and completion of all background check requirements with the COR.

1.6.4.1 U.S. Citizen: U.S. Citizenship (copy of birth certificate or naturalization papers required). Contract personnel performing under this contract must be U.S. citizens. In addition, if any contract personnel fail to meet the citizenship requirements stated herein the Contractor shall not hold the government liable for not allowing performance under this contract.

Contract personnel that work with or teach youth under the age of 18 years are subject to U.S background checks. The Requiring Activity Manager will determine the extent of background checks required. Contract personnel may begin performance of the contract after receiving a favorable local background check. The Contractor agrees to replace any contract personnel should results of the background check, if required, be unfavorable as determined by the Requiring Activity Manager. The Contractor’s replacement of contract personnel with the unfavorable background check shall be provided within 30 calendar days. The Contractor shall also replace contract personnel whose background check, during their tenure of employment, renders them with an unfavorable local or state background check, as determined by the Requiring Activity Manager. The Contractor shall forward a copy to the KO and COR of each favorable and unfavorable background check within the first seven (7) calendar days of each month, along with the associated contract number and position type (A.006). When the Government awards a non-personal services contract directly to an individual, the failure of the individual to provide a favorable background check would be grounds for termination.

1.6.4.2 Personal Appearance / Work Attire: Contract personnel working under this contract shall maintain a clean, neat, and professional appearance upon entering the MTF (prior to changing into scrubs, if applicable). Contract personnel shall not wear clothing made of see-through material, cutoffs, tank tops, torn/ripped clothing, sleepwear, sandals or clothing that displays offensive slogans or images. Contract personnel shall not wear athletic or athletic styled clothing (e.g., shorts, jogging suits, sweat suits, leggings, or t-shirts). In all cases, contract personnel clothing shall fit to provide a professional appearance in keeping with the normally accepted standards of dress, and not present an unfavorable appearance upon the Government.

1.6.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for contract personnel use. At the close of each work period, Government facilities, equipment, and materials shall be secured IAW the Army Physical Security Program (AR 190-13).

1.6.6 Operations Security (OPSEC) Requirements: Contract personnel shall adhere to facility security policies and restrictions. Contract personnel shall immediately report suspicious activities to security personnel. Government issued access badges shall not be worn outside designated facilities where visible to the public.

1.7 Key Control: The Contractor shall establish and implement methods of making sure all keys issued to contract personnel by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE - All references to keys include key cards. No keys issued to contract personnel by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Contractor’s QCP as identified in paragraph 1.5.1 above. Such procedures shall include turn in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any incidents of lost or duplicate keys to the KO. In the event any keys, other than Master keys, are lost or duplicated the Contractor shall, upon direction of the KO, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from payment due to the Contractor. In the event a Master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the payment due to the Contractor. The Contractor shall prohibit the use of Government issued keys by any persons other than the contract personnel. The Contractor shall prohibit the opening of locked areas by contract personnel to permit entrance of persons other than contract personnel engaged in the performance of assigned work in those areas, or personnel authorized entrance by the KO. The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the QCP.

1.8 Post-Award Conference/Periodic Progress Meetings: The Contractor shall attend any post-award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, shall meet periodically with the Contractor to review the Contractor's performance.

At these meetings, the KO or will apprise the Contractor of how the Government views their performance and the Contractor shall apprise the Government of any problems experienced, if any. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government. The Contractor shall not make unplanned visits to the MTF without prior approval from either the KO or COR.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the KO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the KO. The designation letter states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the KO and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of contract personnel.

1.10 Key Personnel: The Contractor shall designate in writing both a Contract Manager and Alternate Contract Manager to the KO and COR at least seven (7) calendar days prior to the commencement of services. The Contract Manager and Alternate Contract Manager will coordinate the implementation of services and be responsible for the performance under this contract. Contract Managers shall have full authority to act on behalf of the Contractor on all contract matters relating to the daily operation of this contract, and the Alternate Contract Manager shall act on behalf of the Contractor should the Contract Manager be unavailable.

The Contract Manager and/or Alternate Contract Manager shall be available during the Contractor Support Hours, as identified in paragraph 1.5.4.3. The Contractor shall immediately notify the KO and COR of any changes to the designated Contract Manager and/or Alternate Contract Manager and provide a designated replacement in writing within seven (7) calendar days after said change.

(a) Contract Manager & Alternate Contract Manager: The Contract Manager and/or Alternate Contract Manager shall submit to the COR for review a Profile Application Packet with a Curriculum Vitae (CV) for each contract candidate, prior to beginning services under this contract. Submitted Profile Application Packets with CVs shall detail each contract candidate’s years of experience, employment history, education, and associated certifications in relation to this requirement. The COR will then forward the Profile Application Packet to the Department for a final review. The Department will then approve or disapprove the submitted Profile Application Packet within seven (7) calendar days of receipt. No personal interviews shall be conducted by the Government.

(b) Special Qualifications: The Contractor shall ensure that all contract personnel are fully trained and qualified to provide a high level of quality services under this contract, as required for each position type. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential and shall maintain an adequate workforce for the uninterrupted performance of all tasks defined within this

PWS.

(i) Experience: Contract personnel must have a minimum of 5 years of experience within the last 7 years providing services as a Clinical Research Associate specific to Radiation Therapy Services and protocol management.

While providing services under this contract, contract personnel are required to comply with any applicable state laws concerning their profession.

(ii) Education: Bachelor’s Degree. Contract personnel must be a graduate of an approved accredited college program. Foreign medical graduates must pass the Educational Commission Foreign Medical Graduate (ECFMG) test, as given by the EFCMG. Contract personnel shall meet all Continuing Medical Education (CME) requirements. CME requirements are the responsibility of the Contractor and shall be obtained at no cost to the Government.

(iii) Certification: It is a condition of this contract that all required certifications in this PWS remain current during the life of the contract. Certifications required under these qualifications are the responsibility of the Contractor and shall be maintained at no cost to the Government.

Contract personnel must have and maintain a current certification in Basic Life Support (BLS) and Advanced Life Support (ALS) from the American Heart Association (AHA).

(iv) Licensure: It is a condition of this contract that all required licenses in this PWS remain current during the life of the contract. While providing services under this contract, contract personnel are required to have and maintain a current, valid, unrestricted license to legally practice in at least one (1) of the 50 states in the United States or the District of Columbia, the Commonwealth of Puerto Rico, or a U.S. Territory. Contract personnel are also required to comply with any applicable state laws concerning their profession. Licenses required under these qualifications are the responsibility of the Contractor and shall be maintained at no cost to the Government.

(v) Professionalism: Contract personnel must exercise a positive, helpful demeanor, display courtesy and tact frequently under stressful conditions and duress at an accelerated pace due to life threatening patient situations.

Contract personnel shall possess sufficient initiative, interpersonal relationship skills and social sensitivity such that he/she can relate constructively to a variety of patients from diverse backgrounds.

Contract personnel shall not bill a patient for services rendered under this contract. Contract personal shall be prohibited from receiving compensation of any kind for patients treated, procedures performed, or any other actions performed, except under the terms and conditions of this contract, and at the rate specified. Contract personnel shall not, while performing services under this contract, advise, recommend or in any way suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor or any contract personnel at any place other than the MTF.

(vi) Other: Position requires access to DoD computer systems; therefore, provider shall be a U.S. Citizen or otherwise meet the requirements of AR 25-2.

Contract personnel shall be able to read, write, and speak English well enough to effectively communicate with all patients and other personnel.

The Contractor shall not employ contract personnel to provide services under this contract that are currently employed by the U.S. Government, either as active military or civil service. Such employment would be considered as a conflict of interest, in accordance with DoD 5500.07-R.

1.11 Identification of Contract Personnel: All contract personnel that attend meetings, answer Government telephones, or work in other situations in which their contract status is not obvious to third parties, must identify themselves as contract personnel, to include proper marking of signature blocks in correspondence to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports produced by contract personnel are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12 Contractor Identification Badges: The Government MTF will provide identification Badges to contract personnel for specific door access. Contract personnel shall wear the MTF-issued Badges on their outermost garment at all times while providing services at the MTF, unless directed otherwise by protocol (such as in the Operating Room). The Contractor shall collect all ID Badges upon completion of the contract, or termination of employee. A listing of issued ID cards shall be furnished to the KO prior to the contract performance date and updated as needed to reflect the contract personnel changes (A.007).

1.13 Contract Personnel Travel: Reserved

1.14 Other Direct Costs: Reserved

1.15 Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the KO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.16 Protection of Government & Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/, the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.17 Non-Disclosure Requirements: Performance under this contract may require contract personnel to access data and information that is proprietary to a government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this PWS would be adverse to the interests of the Government or others. The Contractor and contract personnel shall not divulge, or release data or information developed or obtained under the performance of this PWS, except to authorized Government personnel or upon written approval of the KO. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.18 Non-Disclosure Statements: The Contractor shall provide a signed non-disclosure agreement to the Government within seven (7) days prior to commencement of services under this contract (A.008). Any unauthorized disclosure of information by contract personnel may result in the individual being removed from the contract. Standard non-disclosure statements shall be provided, as required, for personnel who may have access to Government data in the course of their duties.

1.19 Organizational Conflict of Interest: Reserved

1.20 Phase-In / Phase-Out Period: To minimize decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 30-day phase-in/phase-out periods. During the phase-in period, the Contractor shall become familiar with performance requirements to commence full performance of services on the contract start date.

1.21 Removal of Contract Personnel: During the performance of this contract, the Government reserves the right to immediately require the temporary removal of any contractor personnel whose actions or impaired state raises reasonable suspicion that clear and present danger of harm exists to either patients, MTF personnel or to themselves. This provision is intended for emergency situations only, and not for the purpose of bringing performance issues or other non-urgent concerns to the attention of the Contractor. Upon removal, the Contractor will be provided notification within 24 hours, and request a formal meeting with the KO, COR, and/or Department to discuss further action. The KO will make the final determination as to whether the temporary removal of any contract personnel should become permanent. The permanent removal of contract personnel does not relieve the Contractor of any performance requirement.

1.22 Environmental Compliance: Reserved

1.23 Required Training

1.23.1 Anti-Terrorism (AT) Level I Training: All contract personnel, including subcontractor personnel, who are employed under the contract, shall complete AT Level I Training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies, or within 30 calendar days after employment of new personnel. The Contractor shall submit certificates of completion (A.009) for each affected contract personnel and subcontractor personnel to the COR (or to the KO, if a COR is not assigned) within seven (7) calendar days after completion of this training by all contract personnel and subcontractor personnel. AT Level I awareness training is available at https://jkodirect.jten.mil. Contract personnel shall complete refresher training every 12 months except AOR specific AT Level I Training which shall be completed as required by local AT policies. Verification of the refresher training shall be provided to the COR within seven (7) calendar days after completion of the training (A.009).

If training cannot be conducted on the website, the Contractor shall coordinate with the COR who will contact the local AT Officer at their assigned location for classroom training. Contract personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the AT Officer. Verification of the training shall be provided to the COR within seven (7) calendar days after completion of the training (A.009).

1.23.2 Operations Security (OPSEC) Training: All contract personnel, including subcontract personnel, shall complete Level I OPSEC training Per AR 530-1, within 30 calendar days of employment under this contract (A.010). Verification of the training shall be provided to the COR within seven (7) calendar days after completion of the training. OPSEC Level I Training is available at http://www.cdse.edu/catalog/elearning/GS130.html. Contract personnel must complete refresher training every 12 months. Verification of the refresher training shall be provided to the COR within seven (7) calendar days after completion of the training (A.010).

If training cannot be conducted on the website, the Contractor shall coordinate with the COR, who will contact the local OPSEC Officer at their assigned location for classroom training.

Contract personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the OPSEC Officer. Verification of the training shall be provided to the COR within seven (7) calendar days after completion of the training (A.010).

1.23.3 iWATCH Training: The Contractor and all associated subcontractors shall brief all contract personnel on the local iWATCH program (training standards provided by the requiring activity AT Officer). This locally developed training will be used to inform contract personnel of the types of behavior to watch for and instruct contract personnel to report suspicious activity to the COR. This training shall be completed within 30 calendar days after the contract is awarded and within 30 calendar days after new contract personnel commence contract performance, with the results reported to the COR within 30 calendar days after the contract is awarded (A.011). Training can be found on the website:

http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx.

1.23.4 Information Assurance (IA) Training:

1.23.4.1 All contract personnel, including subcontract personnel, requiring access to Government information systems shall complete the DoD IA Cyber Awareness Training before the issuance of network access (A.012). Contract personnel must complete refresher training every 12 months. Verification of the refresher training shall be provided to the COR within seven (7) calendar days after completion of the training (A.012).

1.23.4.2 All contract personnel, including subcontract personnel, working Information Technology (IT)/Information Awareness (IA) functions shall comply with DoD and Army training requirements per IA Training Certification and Workforce Management DoD Directive (DoDD) 8570.01, IA Workforce Improvement Program DoD 8570.01-M, and AR 25-2 within six (6) months of appointment to IA/IT functions. Training can be found on the following website:

https://ia.signal.army.mil/DoDIAA/default.asp.

1.23.4.3 All contract personnel, including subcontractor personnel, performing services under this contract with access to Government information systems must be registered in the Army Training Certification Tracking System (ATCTS) at commencement of services, the web address is https://atcts.army.mil (requires CAC to access).

1.23.5 Protected Health Information (PHI): Contract personnel, including subcontract personnel, performing services under this contract with access to PHI and Government information shall complete “HIPAA & Privacy Act Training” per DoDI 5400.11-R, before the issuance of network access (A.013). Contract personnel must complete refresher training every 12 months. Verification of the refresher training shall be provided to the COR within seven (7) calendar days after completion of the training (A.013). Training is available at https://jkodirect.jten.mil.

1.23.6 DHA Employee Safety Course: Contract personnel, including subcontract personnel, performing services under this contract shall complete the “DHA Employee Safety Course” per DoDI 6055.01, within 30 calendar days of employment under this contract (A.014). Verification of the training shall be provided to the COR within seven (7) calendar days after completion of the training. Contract personnel must complete refresher training every 12 months. Verification of the refresher training shall be provided to the COR within seven (7) calendar days after completion of the training (A.014).

1.23.7 Joint Staff Insider Threat Awareness: Contract personnel, including subcontract personnel, performing services under this contract shall complete the “Joint Staff Insider Threat Awareness” per DoDI 1322.31, within 30 calendar days of employment under this contract (A.015). Verification of the training shall be provided to the COR within seven (7) calendar days after completion of the training. Contract personnel must complete refresher training every 12 months. Verification of the refresher training shall be provided to the COR within seven (7) calendar days after completion of the training (A.015).

1.23.8 New Employee Orientation (NEO): Newly in-processed contract personnel shall be required to complete New Employee Orientation (NEO) training provided by the MTF.

Thereafter, all contract personnel shall be required to complete mandatory training to meet competency requirements. Orientation and annual training requirements are a condition of employment. All contract personnel shall also participate in orientation to their work area and maintain a competency file (which is different from a credentials file) at the worksite in accordance with TJC standards.

1.23.9 MHS Genesis: The Government will provide training to contract personnel in MHS Genesis, at no additional expense to the Contractor. When directed by the KO, contract personnel shall attend this training in a paid status as part of the normal services required and billed under the contract. Access to such patient data systems is an "Automated Data Processing Sensitive" position requiring compliance with AR 380-19 and AR 380-67.

1.24 Sexual Assault Prevention & Response Program (SAPR)

1.24.1 The DoD’s goal is to provide a culture free of sexual assault through an environment of prevention, education, training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well-being of all persons covered by the DoD Directive. The DHA is one (1) of the agencies of the DoD, and as such follows the directives, instructions, and guidance of the DoD.

1.24.2 All contract personnel will comply with the Department of Defense Directive (DoDD) 6495.01, SAPR Program. More information is available via the following weblink:

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/649501p.pdf?ver=MlV9x4 KYK2qsh38GtGegBw%3d%3d.

1.25 Reserved

1.26 Reserved

1.27 Government Property (GP) & Services: Refer to Part 3 of this PWS for GP for this contract. For all issued GP for this contract, the Contractor shall submit a Property Management Plan to the KO via the COR within seven (7) calendar days after date of contract award (A.016).

PART 2

DEFINITIONS & ACRONYMS

2 Definitions & Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Ancillary Personnel – This includes all HCPs except for Medical Doctors (MD) and Doctors of Osteopath (DO).

Backup Personnel – Pre-approved contract personnel designated to move into the position of the primary contract personnel to perform required services for the duration of his/her absence.

Beneficiaries of the Military Healthcare System – Those individuals entitled to care at the MTF in accordance with AR 40-3.

Clinical Privileges – Authorization by the government to provide specific patient care and treatment services in the organization, within well-defined limits, based on the individual’s license, education, training, experience, competence, judgment, and physical and mental health.

Composite Healthcare System (CHCS) – An automated medical information system which will provide integrated support for the functional work centers of inpatient and outpatient care facilities, patient administration, patient appointments and scheduling, nursing, laboratory, pharmacy, radiology, and clinical dietetics.

Continuing Education – Education beyond initial professional preparation relevant to the type of patient care delivered in the organization provides current knowledge relevant to the field of practice and is related to findings from quality assurance activities.

Contracting Officer (KO) – A person with the authority to enter, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. NOTE - The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s Technical Representative (COTR), technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2- 2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the KO as alternate CORs.”

Contractor – Supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contract Personnel – Individuals employed by the Contractor to perform services.

Contractor-acquired Property – Property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – Unless otherwise specified, refers to a calendar day.

Defective Service – Service output that does not meet the standard of performance associated with the PWS.

Deliverable – Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Facilities – Building, equipment and supplies necessary for the implementation of service by personnel.

Full-Time Equivalent (FTE) – The Contractor is required to provide 1,920 Regular Hours, which averages 160 Regular Hours per month or 40 Regular Hours per Work Week, for each FTE over a 12-month period. The following FTE determination can be used as a general reference:

1.00 FTE = Averages…