A01_-_PWS_Study_Coordinator_-_Basic_IDIQ_Final.pdf

Performance Work Statement (PWS)

STUDY COORDINATOR SERVICES IDIQ at TRIPLER ARMY MEDICAL CENTER May 2018

C.1. BACKGROUND.

The mission of the military healthcare system (MHS) is to ensure the nation has available at all times a healthy military force supported by a combat ready healthcare system. Health care services for eligible MHS beneficiaries are provided at military treatment facilities (MTFs) located on or near military installations or posts. The military treatment facility may be a clinic, Hospital, or Medical Center. Clinics are outpatient facilities offering primary care or simple specialty care (routine exams, tests, treatments). The Clinic may be a stand-alone site or a satellite of a larger Clinic, Hospital, or Medical Center. Army Community Hospitals (ACH) 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. Army Medical Centers (MEDCENs) offer tertiary (sophisticated diagnosis/treatment of any ailment), secondary, and primary care, hospital services, preventive services, blood bank, and other services. In addition, all MEDCENs offer graduate medical education programs for physicians.

C.1.1. The Department of Clinical Investigation promotes the advancement of healthcare and support of graduate medical education at Tripler Army Medical Center (TAMC) through biomedical investigation studies. These studies are done to keep TAMC at the forefront of biomedical technologies and to develop improvements in health care delivery. Through collaborative efforts, TAMC leverages scientific expertise within the biomedical community which in addition to contributing to new medical knowledge, positively impacts the graduate medical education program at TAMC by creating an environment of scholarly inquiry.

C.1.2. INTRODUCTION.

C.1.2.1. The Contractor shall provide the non-personal services of Study Coordinators to specificclinical or translational studies, and shall provide input to the Principal Investigator (PI)/designated point of contact (POC) for the Department of Clinical Investigation. The Contractor shall adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

C.1.2.2. The Contractor shall ensure that all services are provided in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Joint Commission on Accreditation of Healthcare Organizations (JC) standards, applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and military treatment facilities (MTF) specific policies, procedures, and job descriptions. Contract health care providers (contract personnel) shall give the highest regard to patient dignity and observe the precepts of the American Hospital Association’s Bill of Rights for Patients. The Contractor shall provide non-personal services for varied ancillary healthcare specialties in accordance with established principles and ethics of the medical profession, the national standards established by the JC, the professional standards at the medical treatment facility (MTF), and the American Board of applicable specialty. The Contractor shall be held accountable for compliance to the standards listed in the Comprehensive Accreditation Manual for Hospitals (CAMH) dated January 2011 or current version.

C.1.2.3. The Contractor employees shall provide services to principal investigators, scientists, physicians, nurse practitioners, physician assistants, registered and licensed practical nurses, and support personnel.

C.1.2.4. This contract is a non-personal services contract under which the Contractor employees 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.

C.1.2.4.1. RESERVED

C.1.2.4.2. Responsibility and Procedures.

C.1.2.4.2.1. If any suit or action is filed or any claim is made against the Contractor, which occurred as a result of work performed by the Contractor under this contract, the Contractor shall immediately notify the Contracting Officer and the chief of the appropriate services and promptly furnish them copies of all pertinent papers received.

C.2. Objective

C.2.1. The Contractor shall provide Study Coordinator services to Government-led clinical and translational studies. The Study Coordinator will work directly with the Principal Investigator/designated POC and perform duties to include: collecting, organizing, maintaining and disseminating patient data files, reviewing patient records for eligibility in the study; screening study subjects, enrolling subjects, and monitoring subjects; obtaining specimens for laboratory analysis; performing statistical data analysis and provide written reports of the findings.

C.3. Requirement

C.3.1. Administrative.

C.3.1.1. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five business days after receiving notice of contract award.

Changes in the primary POC, at any time, shall require the Contractor to notify the Contracting Officer (KO) of the new representative at least five working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

C.3.1.2. The Government’s Representative will be the KO’s authorized representative in administering the contract at the MTF level. The Government’s Representative shall be available to discuss any problems that the Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

C.3.1.3. The use of non-compete conditions in employment agreements or in subcontracts (to prevent loss of personnel by the Contractor) effective only during the period of the contract performance is acceptable. However, the use of non-compete conditions in employment agreements and/or in subcontracts that prevent employees and/or subcontracts by the new Contractor on the follow-on contracts is unacceptable. Inclusion of such conditions in an employer’s employment agreement and/or subcontracts will result in an offeror’s proposal being unacceptable.

Awardee, and their subContractors, may not include such conditions in employment agreements and/or subcontracts while performing under this contract.

C.3.1.4. The Contractor and contract personnel shall abide by all MTF standards, rules, and procedures including requirements for any licensure, credentialing and quality assurance requirements such as general safety, fire prevention, waste disposal, infection control, JC, and patient safety initiatives. All standards, rules and procedures are available via the Government’s Representative.

C.3.1.5. Media and Other Inquiries. The Contractor shall not respond to any media inquiries. Any inquiries from the media, third parties, or public agencies shall be immediately relayed to the Government’s Representative, who will relay them to the MTF Public Affairs Officer or, after duty hours, to the Administrative Officer of the Day (AOD). There shall be no interviews, comments, or any other response without the knowledge and approval of the MTF Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the Government’s Representative.

C.3.1.6. Emergency health care for contract personnel. The MTF will provide emergency healthcare for injuries or life threatening medical emergencies occurring while on duty at the MTF. The Contractor shall reimburse the Government for such services as billed by the MTF.

C.3.2. Conflict of Interest

C.3.2.1. The Contractor or Contractor employee shall not bill any individual for services rendered under this contract. The Contractor or Contractor employee shall not request or accept compensation of any kind for procedures performed, or any other actions performed, from any individual except for billing as appropriate under the terms and conditions of this contract, at the rate specified.

C.3.2.2. The Contractor or Contractor employee shall not, while performing services under this contract, advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor or Contractor employee or from any third party at any place other than as designated under this contract.

C.3.2.3. Confidentiality of Information. Unless otherwise specified, all financial, statistical, personnel, and/or technical data which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of healthcare services under this contract. The Contractor shall not release any of the above information without prior written consent of the KO. The Contractor/Contractor employee shall not use patient care rendered pursuant to this contract as part of a study, research project, or publication. The Contractor employee shall prepare medical records, forms and documents as required, in accordance with the regulations and established guidelines listed in the contract.

C.3.2.4. Contractor will abide by federal employment statutes and the Federal ethics regulations in the selection and hiring of Contractor personnel.

C.3.2.5. The Contractor or contract personnel shall not use Government facilities, supplies, or equipment in private practice or for any purpose other than providing the non-personal services required under this contract.

C.3.3. Security.

C.3.3.1. Security Identification Badges. The Contractor and Contractor employee shall comply with the local installation and MTF personnel identification and access requirements while on site.

C.3.3.1.1. While on site, each Contractor employee shall wear a visible security badge identification, provided by the military installation or the MTF, on the front of his/her outer clothing. The badge must show the full name, title and if required by the Military the word “Contractor” in front. The Government’s Representative will provide the paperwork to request identification badges.

C.3.3.1.2. The Contractor is responsible for absences of Contractor employees due to expired identification and access documents. Such absences shall not relieve the Contractor of its obligation to perform the services required under this contract.

C.3.3.1.3. The Contractor employee shall immediately report any lost or stolen badges to the Government’s Representative.

C.3.3.1.4. The Contractor employee shall turn in all identification badges to the Government’s Representative, or his/her designated representative upon termination of their services under this contract.

C.3.3.2. Vehicle Registration. The MTFs are located on restricted access military installations. The Contractor employee shall comply with the local installation requirements for vehicle registration and operation on the military installation.

C.3.4.2.1. All vehicles, with or without a DoD decal, are subject to search. Contractor employee may encounter long delays for vehicle inspection and identification checks upon entering and exiting the installation. The Government will not reimburse the Contractor for time spent at installation checkpoints. Contractor employee must plan accordingly and report to work at their scheduled duty time, at their appointed place of duty within the MTF.

C.3.3.3. Keys. The Contractor shall be responsible for any keys issued by the Government to Contractor employee for use in the MTF. The keys shall not be duplicated. The Contractor shall be financially responsible for the replacement of any lost keys and any associated locks. Lost keys and/or locks shall be reported to the issuing party, Department Chief, or Government’s Representative immediately upon recognition of the loss.

C.3.3.4. Safeguarding Material. The contract shall ensure that its employees are responsible for safeguarding all Government property. The Contractor shall safeguard information of a confidential or sensitive nature. All patient related information is considered confidential and sensitive. If working remotely, Contractors are prohibited from reproducing patient information in any way to include printing. Neither the Contractor nor any of its contract personnel shall disclose or cause to be disseminated any information concerning the operation of the MTF that could result in or increase the possibility of a breach in security or interrupt the continuity of operations or which breach the requirements of the Federal Privacy Act of 1974. However, the Contractor may be required to provide testimony or disposition in cases of due process action.

C.3.4. Orientation and Training.

C.3.4.1. MTF in-processing checklist. When commencing work under this contract, the Contractor employee shall obtain in-processing checklist(s) from the Government’s Representative or designated office. All Contractor employees are required to complete the applicable items on the checklist and turn it in to the designated office.

Upon completion of the duty assignment, the Contractor employee need to complete an out-processing checklist and return it to the designated office.

C.3.4.2. MTF and Unit Orientation. The Government will provide orientation to familiarize the Contractor employee with the policies and procedures of the MTF, assigned department and specific unit within 45 days of contract award.

C.3.4.3. Annual training requirements. The Contractor shall ensure that Contractor employee complete any mandatory annual Government unique training requirements in accordance with MTF procedures. The Contractor is responsible for any non-Government unique training.

C.3.4.4. Government unique training. The Government may elect to provide unique Government training to Contractor employee who are performing services under this contract. If the Government elects to provide such training, the Government will provide such training at no additional expense to the Contractor or to the Contractor employee. When directed by the KO, Contractor employee shall attend all such training in a paid status as part of the normal services required and billed under the contract. Such training shall require a performance commitment by the Contractor and the Contractor shall reimburse the Government (by means of a reduction in an invoice) if a contract personnel fails to satisfy the performance commitment after the contract personnel receives the unique Government training. The amount of the reimbursement shall be the prorated cost of training, calculated based on the total cost of the training and the number of months by which the Contractor employee fails to complete the performance commitment. The length of the performance commitment shall be 12 months or until the end of all performance under this contract, whichever occurs first.

C.3.4.5. Computer Training. Contractor employee who have any interaction with the MTF computer systems must receive training for the applicable system(s). The Government’s Representative will coordinate the necessary computer training. The training will be on-site and during normal duty hours at no cost to the Contractor and include such systems as:

C.3.4.5.1. Composite Healthcare Computer System (CHCS) is the military’s world-wide automated medical information system interfaces with 40 plus external clinical and administrative systems.

C.3.4.5.2. Armed Forces Health Longitudinal Technology Application (AHLTA) contains the MTF’s appointment scheduling program, pharmacy, lab, and radiology ordering system and is interlinked with other departments in the MTF. In addition, it contains the electronic medical records for MHS beneficiaries.

C.3.4.5.3. Ambulatory Data System (ADS). This computer system produces forms on which the providers identify the appropriate billing codes for diagnoses and procedures for each patient. In addition, contract personnel working in Labor and Delivery will be trained on the Labor and Delivery Statistics System (LADS).

C.3.4.6. Sexual Harassment/Assault Response and Prevention (SHARP). The Contractor shall ensure all contract personnel receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after the contract Study Coordinator begin performance under this contract. Training can be obtained either online or in person as offered at the installation where services are being provided. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

C.3.3.6.1. POLICY FOR REPORTING INCIDENTS OF SEXUAL ASSAULT AND SEXUAL HARASSMENT

UNDER SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP).

C.3.3.6.1.1. The Contractor shall comply with OTSG/MEDCOM Policy Memo 13-062, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP), 12 Nov 2013. The SHARP reporting requirements apply only to knowledge obtained by Contractor personnel while performing services under this contract.

C.3.3.6.1.2. The Contractor shall require all contract personnel with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the Government’s Representative. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals.

C.3.3.6.1.3. The Contractor shall require all contract personnel with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the Government’s Representative. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals.

C.3.4.7. AT/OPSEC REQUIREMENTS

C.3.4.7.1. AT Level I Training. All Contractor employees, to include subContractor employees, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The Contractor shall submit certificates of completion for each affected Contractor employee and subContractor employee, to the Government’s Representative within 30 calendar days after completion of training by all employees and subContractor personnel. AT Level I awareness training is available at the following website: https://atlevel1.dtic.mil/at.

C.3.4.7.2. Access and General Protection/Security Policy and Procedures. Contractor and all associated subContractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The Contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

C.3.4.7.3. For Contractors requiring Common Access Card (CAC). Before CAC issuance, the Contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with inquires (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The Contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

http://www.atsc.army.mil/tadlp/delivery/alms.asp

C.3.4.7.4. iWATCH Training. The Contractor and all associated sub-Contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 7 calendar days of new employees commencing performance with the results reported to the COR NLT 7 calendar days after completed training.

C.3.4.7.5. Army Training Certification Tracking System (ATCTS) registration for Contractor employees who require access to Government information systems. All Contractor employees with access to a government info system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DoD Information Assurance Awareness prior to access to the information systems and then annually thereafter.

C.3.4.7.6. For Contracts that Require OPSEC Training. Per AR 530-1, Operations Security, new Contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

C.3.4.7.7. For Information assurance (IA)/information technology (IT) training. All Contractor employees and associated sub-Contractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All Contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M and AR 25-2 within six months of appointment to IA/IT functions.

C.3.4.7.8. Threat Awareness Reporting Program. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

C.3.5. MTF HOURS OF OPERATION

C.3.5.1. ACH’s and MEDCEN’s provide services 24 hours a day, 365 days a year (366 days during leap years) including holiday. Clinics have designated operating hours.

C.3.5.1.1. The Department of Clinical Investigation’s operating hours is 8:00 AM thru 5:00 PM Monday thru Friday (HST) excluding federal holidays The Government will provide for flexible hours for contractor employees as warranted by mission needs..

C.3.5.2. Holidays. The following is a list of legal federal holidays. Any of the federal holidays falling on a Saturday will be observed on the preceding Friday, holidays falling on a Sunday will be observed on the following Monday.

Contract personnel may be required to work on legal holidays as determined by the Government’s Representative.

New year’s Day, January 1st Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May 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

NOTE 1: Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a Contractor employee is scheduled to work is closed due to the holiday declared by an Executive Order and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

C.3.5.3. Contractor employee shall report to work as scheduled during emergencies, disasters or during adverse weather conditions. Contract services are still required during these situations unless there is an official closing of the facility or when non-essential workers are instructed not to report.

C.3.5.4. Closures. During anticipated closure of the facility due to Command declared training holidays or unplanned closure of the facility due to natural disasters, military emergencies, severe weather, or otherwise, the Contractors will only be paid for the actual hours that were worked.

C.3.5.5. Overtime on this contract will not be authorized.

C.3.5.6. Contractor employee on this will not be “on call”.

C.3.5.7. The Government’s Representative or their designee will be responsible for communicating with the Contractor regarding scheduling issues. The shift supervisor may act as point of contact after normal duty hours, weekends and holidays. In such cases, the Government’s Representative shall confirm all actions on the next normal working day.

C.3.5.8. Absences and leave:

C.3.5.8.1. The Contractor shall notify the Government’s Representative when a scheduled Contractor employee cannot fill a shift due to illness or emergency. Notification shall be as early as possible, but no later than 2 hours prior to start of scheduled shift.

C.3.5.8.2. The Contractor shall have sufficient qualified personnel available so that all services are provided in the event a Contractor employee scheduled to work becomes ill, resigns, is terminated, or is otherwise unavailable to work. The proposed substitutes shall have at least the minimum qualifications required for the position.

C.3.5.8.3. When the Contractor cannot fill a position, the Contractor shall notify the Government’s Representative.

C.3.5.8.4. Long term scheduled absences of contract personnel shall be coordinated with the Government’s Representative at least 30 calendar days in advance. The Government’s Representative will determine whether or not the Contractor supplies a substitute.

C.3.5.8.5. The Contractor is responsible for submitting an accurate invoice. The Contractor may only invoice and be paid for the services actually rendered. If the Contractor performs fewer services than are provided in the contract schedule, the Government may, at the end of the applicable contract period, deobligate the excess quantities.

C.3.6. RESERVED

C.3.7. LICENSE VERIFICATION AND CREDENTIALS REVIEW OR PRIVILEGING. Contractor Employee will not be performing patient care duties so no patient care credentials review or privileging will be required. The Government’s Representative may request copies of higher education degrees and transcripts of courses taken, or certificates of training for verification of educational or clinical skills (e.g. RN license, medical technician certification, etc) as needed.

C.3.7.1. Reserved.

C.3.7.2. Reserved.

C.3.7.3. Reserved.

C.3.7.4. Removal of Contractor Employee. At any time during the performance of this contract, the Contracting Officer or Government’s Representative may direct the Contractor to immediately remove any Contractor employee from the hospital whose actions or impaired state raises reasonable suspicion that clear and present danger of physical harm exists to a patient, other contract personnel, Government personnel or to the impaired individual.

This provision will be used in emergency situations only and not for the purpose of bringing performance issues or other non-urgent concerns to the attention of the Contractor.

C.3.7.4.1. If the need occurs, the Government’s Representative will contact the Contractor’s point of contact and direct the Contractor to remove that individual from the military facility and to not use that individual to perform any healthcare services required under this contract until the issue has been resolved by the Contracting Officer.

The Contractor shall formally meet with the Government’s Representative to discuss further action in accordance with the MTF Quality Assurance Surveillance Plan (QA&I) and AR 40-68. A review of the basis for removal will be made by the Contracting Officer within 3 working days after the Government’s Representative directed the removal.

C.3.7.4.2. If, after any investigation deemed necessary by the Contracting Officer and discussions with the Contractor's representative, the Contracting Officer concludes that the contract personnel’s impairment requires permanent removal from performance under the contract, the Contracting Officer will notify the Contractor that permanent removal is required. In the event of disagreements between the Government and the Contractor's representative concerning matters of impaired contract personnel, the decision of the Contracting Officer will be final. During the period of time between the removal and the final decision of the Contracting Officer, the Contractor shall provide a backup/replacement contract personnel in accordance with the terms and conditions of this contract.

C.3.7.4.3. The Commander has the prerogative to hold in abeyance, to deny, or to summarily suspend clinical privileges/practice when there is a reasonable cause to doubt the health care provider’s competence to practice or for any cause affecting the safety of patients or others. AR 40-68 outlines the adverse clinical privileging and practice actions for privileged personnel and adverse practice actions and peer review for non-privileged personnel.

C.3.7.5. RESERVED

C.3.7.6. Conduct.

C.3.7.6.1. Contractor’s employees shall comply with MTF policies regarding personal appearance and conduct.

C.3.7.6.2. Contractor’s employees shall abide by federal, state, and local MTF regulations and requirements concerning the nature of limited privileged communication between patients and the contract personnel as may be necessary for security and personnel reliability programs. They shall also abide by federal, state, and local MTF regulations concerning the confidentiality of patient records, as embodied in federal statutes including the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA) of 1996. All medical records and reports will remain the property of the Government.

C.3.7.7. Contractor’s employees shall not introduce new procedures or services without prior approval of the Department Chief or representative. If disagreements or deviations from protocols or procedures occur, the Department Chief or representative shall be the deciding authority.

C.3.8. Health and immunization requirements. All Contractor employees performing services under this contract shall comply with the health and immunization requirements as stated in the TAMC Health Requirements clause.

Backup/replacement contract personnel shall meet the same health and immunization requirements. The expense to comply with the health and immunization requirements shall be borne by the Contractor at no additional cost to the Government.

C.3.9. Criminal History Background Check Requirements. Contractor’s employee determined by the MTF to be involved in the delivery of health care to children under the age of 18 on a frequent and regular basis must meet the requirements of the Crime Prevention Act of 1990, as specified in the Criminal History Background Check Requirements clause.

C.3.10. Contractor Manpower Reporting. "ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor will report ALL Contractor manpower (including subContractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format using the following web address “https://cmra.army.mil. The required information includes: (1) Contracting Office, KO, KO’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of Contractor employee entering data; (5) Estimated direct labor hours (including sub-Contractor);

(6) Estimated direct labor dollars paid this reporting period (including sub-Contractor); (7) Total payments (including sub-Contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub-Contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (10) Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12) Number of Contractor and sub-Contractor employees deployed in theater this reporting period (by country). (13) As part of its submission, the Contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The Contractor shall notify the KO’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the Government’s Representative is unavailable, the Contractor will notify the KO."

C.3.11. TRUSTED ASSOCIATED SPONSORSHIP SYSTEM (TASS).

C.3.11.1. The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

C.3.11.2. The Contractor shall comply with agency personal identity verification procedures in all subcontracts when the subContractor is required to have physical access to a federally-controlled facility or access to a Federal information system.

C.3.11.3. The Contractor shall ensure compliance with the provisions set forth below. For purposes of the Federal Acquisition Regulation (FAR) Clause 52.204-9, the Government will designate a Trusted Agent (TA), and the Contractor shall designate a Facility Security Officer (FSO) for this contract. The Government reserves the right to amend or supplement these provisions pursuant to the Changes clause in the contract.

C.3.11.4. The Contractor is responsible for absences of contract Study Coordinator due to expired identification and access documents. Such absences shall not relieve the Contractor of its obligation to perform the services required under this contract.

C.3.11.5. In-processing Requirements. The Contractor’s employees are prohibited from performing services under this contract absent compliance with the in-processing requirements set forth below.

C.3.11.6. The Government will sponsor the Contractor’s employee for an Army Knowledge Online (AKO) account. All Contractor’s employees e-mail addresses will identify them as a Contractor and use the format firstname.lastname.ctr@mail.mil. The Government will discontinue the AKO when the Contractor employee no longer requires access.

C.3.11.7. The Government TA will send a notice through the TASS to the AKO e-mail address provided IAW the above requirement. The Contractor’s employee’s user ID and password will be provided in the e-mail and will require a change at first login. In the event the e-mail message is not received, the Contractor may request the username and password from the TA and proceed to the website https://www.dmdc.osd.mil/tass to complete the process.

C.3.11.8. The Contractor’s employee shall log into the TASS and complete the verification process by submitting the application back to the TA for approval.

C.3.11.9. The application will be accepted, returned, or rejected by the TA. Notice as to whether the application has been accepted, returned, or rejected will be provided to the Contractor’s employee e-mail address within 48 hours after submission. If the application is returned or rejected, the Contractor employee shall contact the TA and comply with the TA’s guidance to attempt to correct and resolve the issue(s).

C.3.11.10. Upon approval of the application, the Contractor’s employee will receive an e-mail stating the CAC application was approved. The applicant must then go to a RAPIDS Issuing Facility to have the Government credential issued. To make an appointment, the Contractor’s employee will follow the instructions provided by the TA and contact the Government’s Representative for instructions. The Contractor’s employee must present two acceptable forms of ID, which may include: Driver's License, Military ID, Contractor Company ID with picture and expiration date, charge card with picture imprinted, or passport.

C.3.11.11. Revalidation Requirements. The TA is required to revalidate all Contractor’s employees in the TASS, every 6 months. In the event revalidation is denied, the CAC credentials shall be revoked and the CAC will not be useable to log in.

C.3.11.12. Out-processing Requirements. When a Contractor’s employee performance under this contract ceases, the Contractor’s employee shall personally bring the CAC to the TA and complete the DA Form 2962. The TA will revoke the CAC from the TASS.

C.3.12. QUALITY MANAGEMENT

C.3.12.1 The Contractor shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

C.3.12.2. The Contractor shall ensure that all Contractor employees comply with the MTF quality management/process improvement activities.

C.4.0 QUALITY ASSURANCE

C.4.1. Inspection. The inspection and acceptance point for all services rendered under this contract will be the Government’s Representative. The performance by the Contractor employee, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the KO or Government’s Representative. Any services rendered by the Contractor employee to patients or interaction with military/civilian personnel deemed unprofessional, threatening, or dangerous by the KO will be grounds for immediate termination for default or cause. Quality Assurance procedures established by the MTF shall be used for continuous monitoring. Other performance evaluation factors will be monitored that are not quantified by numerical measurements which include: Contractor providing personnel not meeting the minimum qualification standards; inappropriate prescriptions; patient customer service comments;

Contractor relationship with hospital staff/Government contracting personnel; compliance with hospital healthcare policies and procedures.

C.4.1.2. Quarterly Status Meetings. The Contractor shall participate in status meetings, to be held at least quarterly, with the Government’s Representative. The meetings will discuss the progress of the contract, performance of the Contractor, and any problems that have arisen or are expected to arise.

C.5.0. SPECIFIC SERVICE REQUIREMENTS.

C.5.1. Qualifications:

Resume or curriculum vitae which reflects ability to conduct clinical and translational studies including the following: chart reviews, specimen processing, data management, interacting with physicians, scientists, nurses, and other laboratory personnel. Ability to analyze data and summarize findings for incorporation into reports. Must be able to prepare oral and written presentations (as reflected in resume by publications, posters or podium presentations at national conferences, delivery of lectures or scientific presentations, thesis) based on data analysis and study summary. Demonstrated ability (i.e. former work history of managing multiple research studies or clinical trials) to manage multiple clinical and translational studies simultaneously, and develop policies and procedures for clinical study execution and oversight.

C.5.1.1. Education: Contractor employees performing services under this contract shall at a minimum, have a Bachelors of Science in biomedical science field or nursing

C.5.1.2. Experience:

1. Minimum 2 years clinical trial or laboratory study experience. (Study Coordinator I)

2. Minimum 10 years clinical trial or laboratory study experience (Study Coordinator II)

3. Minimum 10 years or successful execution of over 30 clinical trial studies or collaborative biomedical laboratory study experience (Study Coordinator III)

4. Preferred experience in managing investigator-initiated, industry-sponsored, or military studies.

5. Preferred more than 5 years experience with coordination of collaborative partnerships, establishing networks of clinical and laboratory investigators, project management and laboratory analyses.

6. Experience with computers, to include ability to use Word and Excel, ability to retrieve information from computerized data system, development of tracking systems and maintenance of data and research records.

7. Research regulatory compliance experience with Institutional Review Board approvals, Human Research Protection Plans, Data and Safety Monitoring Boards, Quality Assurance of Research Execution.

C.5.1.3. Desirable qualifications include:

1. Biomedical post baccalaureate degree with clinical or translational study experience: M.D., Ph.D., or Masters Degree in biomedical sciences or health care profession

2. Familiarity with statistical analysis and preparing manuscripts for publication.

C.5.1.4 Specific Tasks:

1. The Contractor shall identify potential clinical or translational studies.

2. The Contractor shall determine suitability of TAMC patient population based on inclusion / exclusion criteria and required timeline for study completion.

3. The Contractor shall match sponsored studies with appropriate Principal Investigator.

4. The Contractor shall provide input to the Principal Investigator with all Scientific Review and Institutional Review Board related requirements and any interface with clinical project collaborators or sponsors.

5. The Contractor shall assemble and make recommendations for clinical and translational study teams of study coordinators and other personnel needed to support the execution of the clinical study.

6. The Contractor shall collect, organize, maintain, and disseminate appropriate files of data as required and administer project, writing reports and preparing manuscripts.

7. The Contractor shall review patient records and identify potential eligible patients for inclusion/exclusion in the study. The Contactor shall provide input to study subject enrollment, obtain specimens for laboratory analysis.

8. The Contractor shall interface with other departments throughout TAMC (e.g. Pharmacy) in support of the clinical or translational study. For possible future prospective trials, the Contractor shall oversee consent process, monitor and assess patient response therapy. The Contractor shall ensure that all adverse events are noted and catalogued. For translational laboratory or animal model studies, the Study Coordinator shall provide specimen collecting and processing.

9. The Contractor shall follow study subject course during study and interface with physicians, nurses and technicians to obtain up-to-date information about the study subject's status. The Contractor shall assure that all case reports are completed accurately and in accordance with study sponsor requirements.

The Contractor shall retrieve appropriate data from patient's written and electronic medical records and extract patient information from computer data base, x-ray results, and laboratory/culture results, inputting this data into appropriate forms. The Contractor shall assure that logs and collected data from patients enrolled in the study remain confidential.

The Contractor shall provide written reports of analyses which include evaluation of the statistical limitations of the available data and delineation of possible explanations of the findings. Provide other written progress reports, deviation reports, continuing review reports, and updating of protocol approval documents as needed.

10. For data sets that are in electronic spreadsheet format, the Contractor shall provide analyses within one

(1) week. If data is provided as hardcopy and must be entered into a spreadsheet, an additional week is allowed to input the data.

C.5.2. Basic employee characteristics for all positions.

C.5.2.1. The Contractor shall ensure that all Contractor employees providing services under this contract shall be able to read, write, and speak English well enough to effectively communicate with all parties and other health care providers. In addition, if the position requires the use of computers, the Contractor employees shall be computer literate.

C.5.2.2. The Contractor’s employee 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.

C.5.3. Remote Service.

If services are provided remotely, the Contractor must adhere to all IT requirements for utilizing Government equipment and accessing Government systems. The Contractor shall ensure that all supporting equipment is at it’s own expense. i.e. interfaces, hardware, and software.

C.6.0. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

Following is a list of basic publications applicable to this performance based statement of work. Additional publications may be listed by call. The Contractor is obligated to follow these publications. Current issues of Army publications and links to other service publications can be accessed at http://www.apd.army.mil/. Army publications not on the internet or MTF policies and procedures can be obtained from the MTF. Department of Defense publications can be found at www.defenselink.mil/pubs or www.dtic.mil/whs/directives.

The Publications have been coded as mandatory or advisory. The Contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

Mandatory Publications:

Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration Public Law 104-191 21 Aug 96 Health Insurance Portability and Accountability Act of 1996 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual AR 25-2 Information Assurance AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-3 Medical Services: Medical, Dental, and Veterinary Care AR 40-4 Army Medical Department Facilities/Activities AR 40-5 Preventive Medicine AR 40-66 Medical Records Administration and Health Care Documentation AR 40-68 Clinical Quality Management AR 40-330 Rates Codes, Expense and Performance Reporting Systems, Centralized, Billing, and

Medical Service Accounts AR 40-400 Patient Administration AR 40-407 Nursing Records and Reports AR 40-501 Standards of Medical Fitness AR 40-562 Immunizations and Chemoprophylaxis AR 340-21 The Army Privacy Program AR 380-5 Department of Army Information Security Program AR 380-53 Information Systems Security Monitoring AR 380-67 The Department of the Army Personnel Security Program AR 385-40 Accident Reporting and Records and HSC Supplements AR 608-18 Army Family Advocacy Program AR 600-85 Alcohol & Drug Abuse Prevention and Control Program MEDCOM Pam 25-31 Index of Command Administrative Publications DA PAM 40-11 Preventive Medicine DoD 6055.5-M Occupational Medical Surveillance Manual TG 149 Guidelines for Controlling Occupational Exposure to Hazardous Drugs TG 190 Guide to Managing Exposure to Bloodborne Pathogens TB MED 510 Guidelines for the Recognition Evaluation, and Control of Occupational Exposure to

Waste Anesthetic Gases Advisory Publications.

AMA CPT Physician’s Current Procedural Terminology, updated annually See https://catalog.ama.assn.org TB Med 2 Sterilizing Medical, Surgical, Dental, and Veterinary Material AR 40-501 Medical Examinations AR 190-13 The Army Physical Security Program AR 608-1 Army Community Service Program DA Pam 25-51 The Army Privacy Program: System Notices and Exemptions Rule DoD 1341.2-M DEERS Program Manual DoDD 5200.2 DoD Personal Security DoD 6010.8-R Civilian Health and Medical Program of the Uniformed Services CHAMPUS, Ch 9, 1

Jul 1991 FM 3-19.30 Physical Security PL 89-614 Chapter 55, 10 U.S.C. (1071-1088) Title 29, CFR Occupational Safety and Health Standards

OTSG/MEDCOM

Policy Memo 13-062 Sexual Assault Prevention and Response Program (SHARP)

Current issues of many forms can be accessed at http://www.usapa.army.mil/forms

C.7.0. ACRONYMS…