A01_-_Performance_Work_Statement_-_Basic_IDIQ_Final.pdf

Performance Work Statement (PWS) BIOMEDICAL LABORATORY TECHNICAL SERVICES IDIQ at TRIPLER ARMY MEDICAL CENTER

3 April 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 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 a Biomedical Assistant/Technologist Level 1 Equivalent, Level 2 Equivalent, for the Department of Clinical Investigation, Tripler Army Medical Center which shall contribute to a stable workforce tasked with providing quality health care services to a diverse beneficiary population. This is a non-personal service contract to provide laboratory services and support for researchers and graduate medical education residents for the Department of Clinical Investigation, Tripler Army Medical Center, Honolulu, Hawaii.

C.1.2.2. All services shall be 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 services for varied 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 or contract employees shall provide services in conjunction with other non-contract providers to include physicians, nurse practitioners, physician assistants, registered and licensed practical nurses, and support personnel. All contract employees shall perform essentially the same functions, within the scope of acceptable practice for the specific specialty or position, as those required by Army or Government service health care professionals of similar experience and in similar duty assignments. The scope of services provided in military treatment facilities cover the same range of services as those that are provided in civilian treatment facilities of similar size and scope of services.

C.1.2.4. This contract is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

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 Shall execute biomedical laboratory support to fulfill requirements of clinical investigative studies including clinical trial execution or translational research studies that provide data for design of potential future clinical trials (e.g. physiological and pharmacological experiments assessing cardiovascular, pulmonary, and renal function in animal models of disease or trauma). Work includes specimen retrieval and processing, assay analyses (e.g.

radioimmunoassay, micro plate-based assays, histological and immunohistochemical analyses of tissue specimens (frozen and paraffin-embedded tissue sections), and gene expression analyses.

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 point of contact (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 Contractor’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 subcontractors of the incumbent from being interviewed by, employed, or accepting offers of employment and/or subcontracts by the new contractor on the follow-on contracts is unacceptable. It hinders the government’s ability to accomplish the mission of providing medical care to beneficiaries. 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 regulations include, but are not limited to, general safety, fire prevention, waste disposal, infection control, JC, and patient safety initiatives.

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 contract personnel shall not bill the patient for services rendered under this contract.

The Contractor or contract personnel shall not request or accept compensation of any kind for patients treated, procedures performed, or any other actions performed, except under the terms and conditions of this contract, at the rate specified.

C.3.2.2. The Contractor or contract personnel 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 contract personnel 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/contract personnel shall not use patient care rendered pursuant to this contract as part of a study, research project, or publication. The contract personnel 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 healthcare services required under this contract.

C.3.3. Security.

C.3.3.1. Security Identification Badges. The Contractor and contract personnel 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 contract personnel 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 contract personnel due to expired identification and access documents. Such absences shall not relieve the Contractor of its obligation to perform the healthcare services required under this contract.

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

C.3.3.1.4. The contract personnel 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/contract personnel shall comply with the local installation requirements for vehicle registration and operation on the military installation

C.3.3.2.1. All vehicles, with or without a DoD decal, are subject to search. Contract personnel 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. Contract personnel 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 contract personnel 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 personnel shall be 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. This includes 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 contract personnel shall obtain in-processing checklist(s) from the Government’s Representative or designated office. All contract personnel 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 contract personnel need to complete an out-processing checklist and return it to the designated office.

C.3.4.2. MTF and Unit Orientation. The contract personnel shall be provided with a Government paid orientation to familiarize the contract personnel with the policies and procedures of the MTF, assigned department and specific unit.

C.3.4.2.1. Army Regulation (AR) 40-68 states orientation shall be completed within 45 days of contract award.

C.3.4.3. Annual training requirements. The Contractor shall ensure that contract personnel complete any mandatory annual training requirements in accordance with MTF procedures.

C.3.4.4. Government unique training. The government may elect to provide unique government training to contract personnel 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 contract personnel. When directed by the KO, contract personnel 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 contract personnel 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. Contract personnel 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. This training will be at no cost to the Contractor. These systems include but are not limited to:

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 Biomedical Technician 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.3.4.6.1. POLICY FOR REPORTING INCIDENTS OF SEXUAL ASSAULT AND SEXUAL HARASSMENT

UNDER SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP).

C.3.4.6.1.1. 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.3.4.6.1.2. 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.3.4.6.1.3. 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 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 COR or to the contracting officer, if a COR is not assigned, 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: http://jko.jten.mil

C.3.4.7. 2. Access and general protection/security policy and procedures. Contractor and all associated sub-contractors employees shall 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 (FAR clause 52.204-9, Personal Identity Verification of Contract or Personnel) 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 Inquiries (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 http://www.atsc.army.mil/tadlp/delivery/alms.asp http://jko.jten.mil/ 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.

C.3.4.7. 4. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

C.3.4.7. 5. 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 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

C.3.4.7. 6. 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 IS and then annually thereafter.

C.3.4.7. 7. For contracts that require a formal OPSEC program. The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

C.3.4.7. 8. For contracts that require OPSEC Training. Per AR 530-1 Operations Security, the 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. 9. 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. 10. For information assurance (IA)/information technology (IT) certification. Per DoD 8570.01-M , DFARS 252.239.7001 and AR 25-2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01-M must be completed upon contract award

C.3.4.7. 11. Threat Awareness Reporting Program. For all contractors with security clearances. 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 Contractor shall provide laboratory technical services at Tripler Army Medical Center during flexible hours Sunday thru Saturday, excluding Federal Holidays. Depending upon the biomedical investigation work load the department is requesting, 2 part-time Level 1Biomedical Investigative Assistants along with 1 part-time Level 2 Biomedical Investigative Assistant 20 to 32 hours per week and 1 full-time Level 1 Biomedical Investigative Assistant not to exceed 40 hours per week, to provide laboratory services normally between the hours of 0630 to 2300, based on investigative study demands. At the beginning and ending of each day, and before and after services have been performed; the contract Biomedical Investigative Assistants shall be required to sign-in the time of arrival and sign-out the time of departure on a log sheet to be maintained in the Department of Clinical Investigation.

Arrangement for a flexible work schedule shall be coordinated in advance by mutual agreement between the contract personnel and the POC. Duty hours include an unpaid (1) hour lunch break or an unpaid (1/2) hour lunch break and two (15) minute breaks. Services are to be performed in the laboratories of the Department of Clinical Investigation or in clinical study areas of Principal Investigators within the hospital at Tripler AMC.

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 COR.

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 contract employee is scheduled to work is closed due to the holiday 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. Contract personnel 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.

C.3.5.4. Closures. During anticipated closure of the facility due to Command declared training holidays or during unplanned closure of the facility due to natural disasters, military emergencies, severe weather, or otherwise, the contractor shall not invoice the Government for services not performed and the Government will not be liable to the contractors for any such closures.

C.3.6. HOURS OF PERFORMANCE.

C.3.6.1. Hospitals and Medical Centers provide services 24 hours a day, 365 days a year (366 days during leap years) including holiday. The department has designated operating hours between 0800 to1700, Monday through Friday.

C.3.6.1.1. The contractor shall provide services up to 40 hours per week per person. Scheduled hours may be subject to change in order to account for optimum provision of services and shall be coordinated with the Government’s Representative. There is no overtime rate on this contract.

C.3.6.1.2. The Contractor shall provide laboratory technical services at Tripler Army Medical Center during flexible hours Monday thru Friday, excluding Federal Holidays. Depending upon the biomedical investigation work load about 40 hours per week, technician providing laboratory services will normally be expected between the hours of 0630 to 2300, based on investigative study demands. At the beginning and ending of each day, and before and after services have been performed; the contract Biomedical Technician shall be required to sign-in the time of arrival and sign-out the time of departure on a log sheet to be maintained in the Department of Clinical Investigation. Arrangement for a flexible work schedule shall be coordinated in advance by mutual agreement between the contract personnel and the POC. Duty hours include an unpaid (1) hour lunch break or an unpaid (1/2) hour lunch break and two (15) minute breaks. Services are to be performed in the laboratories of the Department of Clinical Investigation or in clinical study areas of Principal Investigators within the hospital at Tripler AMC.

C.3.6.1.3. Overtime on this contract will not be authorized.

C.3.6.1.4. Individuals on this contract will not be “on call”

C.3.6.2. The Government’s Representative or Director of Laboratory Support Services at the Department of Clinical Investigation 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.3.6.3. Absences and leave:

C.3.6.3.1. The contractor shall notify the Government’s Representative when a scheduled contract personnel 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.3.6.3.2. The contractor shall have sufficient qualified personnel available so that all services are provided in the event a contract personnel 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.3.6.3.3. When the contractor cannot fill a position, the contractor shall notify the Government’s Representative.

C.3.6.3.4. Scheduled absences of contract personnel shall be coordinated with the Government’s Representative at least 30 calendar days in advance. Depending on how the hours are specified will determine whether or not the contractor supplies a substitute.

C.3.6.4. The Contractor is responsible for submitting an accurate invoice.

C.3.7. LICENSE VERIFICATION AND CREDENTIALS REVIEW OR PRIVILEGING.

C.3.7.1 Reserved

C.3.7.2. Reserved.

C.3.7.3. Reserved.

C.3.7.4. Removal of Contract personnel. At any time during the performance of this contract, the Contracting Officer or Government’s Representative may direct the contractor to immediately remove any contract personnel 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 for a removal 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 and Inspection (QA&I) Plan 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.3.7.4.1.2. 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.3.7.4.1.3. 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 nonprivileged personnel.

C.3.7.5. RESERVED

C.3.7.6. Conduct.

C.3.7.6.1. Contract personnel shall comply with MTF policies regarding personal appearance and conduct.

C.3.7.6.2. Contract personnel 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. Contract personnel 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 contract personnel 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. Contract personnel 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 (Government’s Representative) 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 Federal Acquisition Regulation (FAR) Clause 52.204-9, the USG 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 Biomedical Technician 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 contract Biomedical Technician is prohibited from performing services under this contract absent compliance with the in-processing requirements set forth below.

C.3.11.6. The USG will sponsor the contract Biomedical Technician for an Army Knowledge Online (AKO) account. All contract Biomedical Technician e-mail addresses will identify them as a Contractor and use the format firstname.lastname.ctr@mail.mil. The USG will discontinue the AKO when the contract Biomedical Technician no longer require access.

C.3.11.7. The USG TA will send a notice through the TASS to the AKO e-mail address provided IAW the above requirement. The contract Biomedical Technician’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 contract Biomedical Technician 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 contract Biomedical Technician’s e-mail address within 48 hours after submission. If the application is returned or rejected, the HCP 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 contract Biomedical Technician will receive an e-mail stating the CAC application was approved. The applicant must then go to a RAPIDS Issuing Facility to have the USG credential issued. To make an appointment, the contract Biomedical Technician will follow the instructions provided by the TA and contact the Government’s Representative for instructions. The contract Biomedical Technician 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 contract Biomedical Technician, 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 contract Biomedical Technician’s performance under this contract ceases, the contract Biomedical Technician 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 contract 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 contract personnel, 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 contract personnel 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 and Contracting Officer (KO), to be scheduled by the KO. 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 Biomedical Laboratory Technical services of different levels of experience to accommodate various levels of complexity of Command-approved investigative protocols

C.5.1.1. Biomedical technical services will be provided to the Department of Clinical Investigation, Tripler Army Medical Center.

C.5.1.2. The Chief, Department of Clinical Investigation or her representative provides guidance on established administrative policies, procedures, scheduling and regulations and reviews. The alternate POC for this is the Senior, Department of Clinical Investigation Lab Manager.

C.5.1.3. Qualifications

C.5.1.3.1. Education: The contract Biomedical Laboratory Technical services will be paid according to the level of experience. Personnel performing services under this contract shall have the following minimum qualifications based on their level of education or experience. Two separate levels of experience are required for this contract.

Level 1 Biomedical Assistant must have met the educational requirements for a Bachelor’s degree in basic biomedical research field (to include, but not limited to biology, chemistry, zoology, microbiology) or a minimum 2 years demonstrated experience in laboratory research. Level 2 Biomedical Technologist must have a Master’s degree in basic biomedical research field (to include, but not limited to biology, chemistry, zoology, microbiology) or a minimum of 10 years demonstrated experience in laboratory research.

C.5.1.3.2. Licensure/Certification/Registration: None required.

C.5.1.3.3. Experience: Level 1: demonstrated experience in laboratory research to include laboratory course work at the collegiate level. Level 2: a minimum of 10 years demonstrated experience in laboratory research

C.5.1.3.3.1. Level 1: Level 1: Demonstrate laboratory research experience or work on clinical studies to include data collection and analyses. Level 2: Demonstrate research experience in complex biomedical studies including for example, animal model surgical experience, molecular biology DNA analyses, physiological monitoring, radioimmunoassay, biochemical assessments, hormone measurements, human specimen processing, and data analysis for presentation in scientific forums.

C.5.1.3.3.2. Contractor will provide for travel by contract personnel to attend one scientific meeting for presentation of research findings.

C.5.1.3.3.3. PROFESSIONAL KNOWLEDGE. The contract personnel shall possess the following:

C.5.1.3.3.4. Level 1: Knowledge and experience in performing basic laboratory procedures to include but not limited to preparing chemical reagents, processing biological samples and specimens, data recording, experiment record keeping. Level 2: Knowledge and experience in developing and conducting complex biomedical research in the areas of physiology, pharmacology, microbiology, or biochemistry.

C.5.1.3.3.5. Understanding of methodology and design for research.

C.5.1.3.3.6. Level 1: Knowledge and experience with laboratory benchwork. Level 2: Knowledge and experience in human studies, animal studies, radioimmunoassays, ELISAs, and molecular methods.

C.5.1.3.3.7. Level 1: Knowledge and experience with preparing data summaries and quality control lab tests. Level 2: Knowledge and experience with performing data analyses and preparing figures and reports for national scientific presentations and grant reports.

C.5.1.3.3.8. Level 1: Experience with performing data entry and graphics generation for scientific presentations.

Level 2: Experience with setting up data spreadsheets for collaborative research partners to access jointly and maintaining laboratory records in accordance with accreditation standards.

C.5.1.3.3.9.Broad knowledge of computers and related software to include word processing, spreadsheet, data base management, statistical applications, and intranet and Internet connections and applications.

C.5.1.4. General Task Parameters:

C.5.1.4.1. The Level 1 Biomedical Assistant or Level 2 Biomedical Technologist shall provide input in the execution of in vivo and in vitro experiments to fulfill requirements of grant and electrolyte balance testing done by the Research Pharmacology Section, Command approved Tripler Army Medical Center investigative studies for a variety of projects supported by the Department of Clinical Investigation.

C.5.1.4.1.2. The contractor shall meet with the senior Department of Clinical Investigation Lab Manager weekly to review assay laboratory and experiment results and data entry.

C.5.1.4.1.3. The contractor shall provide input in experiments and other physiological, pharmacological assays, human specimen collection and data collection and analyses to assure the meeting of research grant objectives and deadlines.

C.5.1.4.1.5. The contractor shall gather data and execute clinical investigation study protocols including collection and preparation of specimens.

C.5.1.4.1.6. The contractor shall administer drug doses to research animals as specified in research protocols.

C.5.1.4.1.7.