9 - Amendment N62645-21-Q-0002 - 0001 Answer Questions Final.docx

N6264521Q0002

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

ANSWERS TO QUESTIONS

Q1. Is an incumbent contract or contractor associated to the requirement? If any, please provide the contractor's name and contract number.

A1. Intraoperative Neuromonitoring services are currently being provided by NeuroDynamics, Inc., under Contract N62645-16-D-5010-N62645-20-F-0054

Q2. Is it possible to provide the fixed fee rate under the current contract for neuromonitoring at NMCSD?

A2. The current fixed fee rate under the current contract will not be provided. Contractors are expected to perform their own market research in order to submit a competitive quote to the solicitation.

Q3. To clarify, is this solicitation is requesting a flat fee dollar amount for each case duration stipulated in pages 5-12?

A3. That is correct, the quote submitted should be for each case duration listed for both regularly scheduled services and emergency services per section 2.2.1.1 and 2.2.1.2 of the PWS.

Q4. Under this contract, will the provider of neuromonitoring services be able to bill for the professional portion of CPT codes to the patient’s insurance carrier?

A4. Per section 8.2.2.1, intraoperative services are provided on behalf of the Government to active duty, their dependents, eligible Navy civilian employees, and other beneficiaries, as such additional insurance claims are not permissible by the Contractor.

Q5. Under this contract, will the contractor be able to bill for disposable supplies separately or should this be accounted for in the flat fee?

A5. Per section 8.2.4.1, the Contractor’s price should be inclusive of all costs to include required labor, transportation, and consumable items/supplies.

Q6. Estimated Quantities: Are these estimates representative of the full 5-year period or per annum?

A6. As this is a requirements contract the estimated quantities are not a representation of what is required or will be ordered. The estimates provided in this solicitation state a realistic estimated total quantity, for the full 5-year period.

Q7. Section 1 – Scope: 1.2: Can you provide the procedure names which utilized VERs based on historical data?

A7. A list of historical procedures for one year has been provided as attachment 2 in the solicitation.

Q8. Section 6 – Qualifications. 6.4.1-6.4.4: Are these credentials referencing what the online physician must possess in order to provide remote case oversight?

A8. These credentials reference the physician that must be present to provide the intraoperative monitoring live and in person. Section 1.3 of the PWS, has been updated to clarify the required services must be conducted live; remote services are not permitted.

Q9. 6.4.5: Is the CNIM requirement just pertaining to the IONM technologists rendering services (i.e. not required for the remote physician)?

A9. The CNIM requirement pertains to the physician conducting live intraoperative monitoring as remote services are not permitted on this contract.

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

Intraoperative Neuromonitoring Services

UID# 00259162955

Naval Medical Center San Diego, CA

SECTION 1 – SCOPE

1.1. BACKGROUND. This is a non-personal services contract covering a professional discipline which provides healthcare services to eligible beneficiaries of the Department of Defense (DoD) direct care system. The system comprises service-owned, staffed and operated hospitals and clinics throughout the world. Contracting has been chosen as a strategy to permit expansion of the healthcare capacity of DoD facilities by overcoming shortfalls in the numbers of uniformed practitioners and support personnel.

1.2. The contractor personnel shall provide intraoperative neuromonitoring (IOM) services for Naval Medical Center San Diego, CA (hereafter referred to as “NMCSD” and/or “MTF”) for surgical cases requiring live intraoperative neurophysiologic monitoring, auditory brainstem response, visual evoked response (VER), somatosensory evoked potential (Sep or SSEP), electroencephalography (EEG), electromyography (EMG), and nerve conduction studies. Service is required for a variety of surgical cases, including hearing loss, general and vascular surgery, spinal surgery, etc. Note this is not an exhaustive list meant to limit the type of service provided. This list is provided for informational purposes only. The health care services provided under this contract will be provided by an independent contractor.

1.3. SCOPE

The Contractor shall provide credentialed providers to perform live intraoperative neuromonitoring services on site for the Main Operating Room (MOR) in Building 1, Level 4 at the MTF, located at 34800 Bob Wilson Drive, San Diego, CA 92134-5000. Remote monitoring will not be permitted.

SECTION 2 - DUTIES

2.1. GENERAL DUTIES

2.1.1. The Contractor shall perform a full range of duties consistent with their profession, education, training, and experience. General duties that apply to all Contractor personnel are given below:

2.1.1.1. Function with an awareness and application of safety procedures.

2.1.1. 2. Exercise awareness and sensitivity to patient/significant others' rights, as identified within the institution.

2.2. SPECIFIC DUTIES FOR PROVIDING INTRAOPERATIVE NEUROMONITORING SERVICES

2.2.1. The Contractor shall provide intraoperative neuro-monitoring services on an as needed basis. Services required include live intraoperative neurophysiologic monitoring, auditory brainstem response, visual evoked response (VER), somatosensory evoked potential (Sep or SSEP), electroencephalography (EEG), electromyography (EMG), and nerve conduction studies. The Contractor shall provide service in operating rooms (ORs). Work shall be performed in a medical setting. Long periods of standing may be required.

2.2.1.1. Service is required on a case by case basis for scheduled procedures. Performance of services are authorized in conjunction with the issuance of an applicable Task Order. Contractor shall be responsible for providing a toll-free number where the Government representative can call to request services for scheduled procedures. Requests shall be communicated with a live person and a confirmation number communicated to the Government representative. The Government representative will contact the toll free number to provide the date and time for each scheduled procedure to contract personnel approximately fourteen (14) days prior to the requirement for service. Procedures are scheduled during the hours of 0700 to 1700 Monday through Friday (normal operating hours), exclusive of Federal holidays. Contract personnel shall provide service until the end of each procedure, regardless of the time, and shall recognize that there may be instances where cases will not finish until after 1700 hours. Contract personnel shall recognize that the schedule is subject to change within that timeframe.

2.2.1.2. Service for emergency procedures shall be provided at any time Monday through Sunday, including after hours, weekends, and Federal holidays. The Contractor shall be responsible for providing a toll-free number where the Government representative will request services. Requests shall be communicated to a live person with a confirmation number communicated to the Government representative. A Government representative will contact the toll free number to provide notification, no more than 48 hours in advance, of the need for an emergency procedure.

2.2.1.3. The Contractor shall be prepared to provide service on up to three (3) cases at the same time.

2.2.1.4. Due to the nature of the requirement, services may be cancelled or rescheduled at any time prior to the procedure, including the day of the procedure after the Contractor arrives on-site at the MTF. The Government will not reimburse the Contractor for any fees relating to the cancellation or rescheduling of a procedure.

2.2.2. The Contractor shall furnish, set up/prepare, operate, troubleshoot, maintain the cleanliness, and perform inspection and maintenance of the intraoperative neurophysiologic monitoring system and supplies in accordance with the manufacturer’s guidelines. The Contractor shall provide evidence of required inspection/maintenance as requested by the Government.

2.2.2.1. The Contractor shall report to the MTF approximately one (1) hour prior to the start of each procedure to have their equipment undergo a biomedical check-in upon entry to the MTF, to be coordinated with the Contracting Officer’s Representative (COR), contact information to be provided upon award. The Contractor shall be responsible for transporting the intraoperative neurophysiologic monitoring system and all required supplies to the MTF each time service is required. The Government will not provide storage space for Contractor use.

2.2.2.2. The Contractor shall demonstrate detailed technical knowledge and troubleshooting ability for the intraoperative neurophysiologic monitoring system.

2.2.3. The Contractor shall position the patient in the OR, attach electrodes, monitor complex nerve impulses, and notify the surgeon regarding any danger to the patient nerve pathways during a surgical procedure. The Contractor shall be responsible for multiple types of recordings and measurement of the electrical activity of the central and/or peripheral nervous system.

2.2.4. The Contractor shall provide a post-surgical outcome report to the COR within one 48 hours from the end of each procedure. The report shall identify the date, hours worked, patient, and other clinical information as specified by the COR. This report shall be submitted via mail and cannot be submitted electronically as the contractor will not have access to the electronic patient record system or Government network.

2.2.5. Data on the cases completed in the year is provided for historic purposes only, see Attachment 2. The actual number/type/length of cases may vary.

2.3. EQUIPMENT AND SUPPLIES

2.3.1. The Contractor shall furnish all equipment and supplies necessary to operate the intraoperative neurophysiologic monitoring system and provide the services described herein.

2.3.1.1. The Contractor shall provide an intraoperative neurophysiologic monitoring system that can provide the services described herein.

2.3.1.2. The Contractor shall be responsible for supplying all necessary supplies to coordinate with the specific brand of system furnished and provide the services described herein. The following represents an estimated list of the supplies required and shall be used as reference information only: NIM EMG endotracheal tubes, APS electrodes, stim bur, probes, etc. It is the responsibility of the Contractor to ensure that all supplies needed to provide service on both a scheduled or emergent basis are available at all times.

SECTION 3 – HOURS OF OPERATION

3.1. Hours of operation are as described in Paragraphs 2.2.1.1. and 2.2.1.2.

3.2. All closings for severe weather or other emergency shall be at the sole discretion of the government. The Contractor shall maintain the required service schedule unless the COR notifies the Contractor that weather conditions or an emergency authorizes a closing. The Contractor will receive guidance from the COR of the MTF protocol for closings.

SECTION 4 – DELIVERABLES. All deliverables shall be submitted to the Contracting Officer’s Representative (COR) via email in Microsoft Office format, unless otherwise specified.

4.1. Quality Control Program (See Section 9)

4.2. Health Certifications for Employees (See paragraph 10.2)

4.3. Post-surgical outcome reports (See Paragraph 2.2.4)

SECTION 5 – PERFORMANCE

5.1. QUALITY ASSURANCE SERVEILLANCE PLAN (QASP) MATRIX

5.1.1

SECTION 6 – QUALIFICATIONS. The Contractor shall provide personnel having certain minimum levels of training and experience. This section is in no way intended to dictate a staffing plan to the Contractor for the performance of the services delineated in this performance work statement.

6.1. All contract personnel shall possess ad maintain the following minimum qualifications.

6.2. Contract personnel shall maintain current certification in American Heart Association Basic Life Support (BLS); American Heart Association Healthcare Provider Course; American Red Cross CPR (Cardio Pulmonary Resuscitation); or equivalent. Training shall be the responsibility of the contractor and is at no cost to the Government. Contract personnel, not in possession of current certification, must acquire certification prior to initiating contract performance. Web based classes do not meet these standards. A copy of the BLS instruction may be obtained from the World Wide Web at: http://www.med.navy.mil/directives/ExternalDirectives/1500.15E.pdf.

6.3. U.S. citizenship is a basic condition for assignment. U.S. citizens who are also dual citizens are not specifically excluded from occupying either sensitive or designated IT positions, however, a dual citizenship status raises foreign influence and foreign preference concerns that will most likely prohibit interim assignment pending favorable investigation and adjudication of these issues. Eligibility will not be established for persons who hold a foreign passport. See attachment 5.

6.4. SPECIFIC QUALIFICATIONS FOR PERSONNEL PROVIDING INTRAOPERATIVE NEUROMONITORING SERVICES

6.4.1. The service is typically provided by an audiologist; however, services are not required to be provided by an audiologist. The Contractor shall be responsible for determining the specific labor category necessary to provide the services described herein; however, the following qualifications are required:

6.4.1.1. Contract personnel shall possess at least one (1) of the following degrees:

6.4.1.1.1. Master’s degree in Audiology from a college accredited by the Council on Academic Accreditation in Audiology and Speech Language Pathology (CCA-ASHA);

6.4.1.1.2. Doctorate degree in Audiology (Au.D.) from a college accredited by the Council on Academic Accreditation in Audiology and Speech Language Pathology (CCA-ASHA);

6.4.1.1.3. Doctorate degree in Medicine (M.D.) from an accredited college approved by the Liaison Committee on Medical Education and Hospitals of the American Medical Association; or

6.4.1.1.4. Doctorate degree in Osteopathy (D.O.) from a college accredited by the American Osteopathic Association

6.4.2. The Contractor shall possess and maintain a board certification by the American Speech-Language-Hearing Association (ASHA), the American Board of Audiology of the American Academy of Audiology (AAA) or the American Speech-Language-Hearing Association.

6.4.3. Contract personnel shall possess a current, valid, unrestricted license to practice Medicine, State of California (M.D. /D.O.); or Current, valid, unrestricted license to practice Audiology, State of California (Au.D).

6.4.4. Contract personnel shall be current with and have completed all continuing education requirements specified by their professional licensure or certification.

6.4.5. The Contractor shall possess current Certification in Neurophysiologic Intraoperative Monitoring (CNIM).

6.4.6. SPECIFIC KNOWLEDGE FOR PERSONNEL PROVIDING INTRAOPERATIVE NEUROMONITORING SERVICES

6.4.6.1 The Contractor shall possess the following knowledge and, skills, and abilities:

6.4.6.2. Knowledge of scientific rationale in coordination of the patient care.

6.4.6.3. Knowledge of Universal Precautions.

6.4.6.4. Knowledge of safety and environment of care procedures.

6.4.6.5. Knowledge and expertise in the following areas of service: Auditory Brainstem Response (ABR), Visual Evoked Response (VER), Somatosensory Evoked Potential (SEP or SSEP), Electroencephalography (EEG), Electromyography (EMG), and Nerve Conduction Studies.

6.4.6.6. Knowledge of developments in the field of Intraoperative Neurophysiologic Monitoring and Evoked Potentials.

SECTION 7 – CREDENTIALING REQUIREMENTS

7.1. Following contract award, the Contractor shall submit to the Medical Staff Services Office (MSSO), via the COR, a completed Credentials Record (CR) for each required contract employee. The CR, which will be maintained at the MTF, contains specific information with regard to qualifying degrees and licenses, past professional experience and performance, education and training, health status, and competency as identified in DHA PM Number 6025-13 (and subsequent revisions). The Contractor shall not assign an individual to work at the MTF until the HCW’s CR has been approved by the designated Privileging Authority. CRs for contract employees who do not currently have a CR (previously referred to as an Individual Credentials File or ICF) on file at the facility shall be submitted at least 30 days prior to commencement of services. For those contract employees who currently have a CR on file, an updated Personal and Professional Information Sheet (PPIS) for Privileged Providers, with notation that a complete up-to-date CR is on file, shall be submitted no less than 15 days prior to commencement of services. Prior to contract employees providing services, the COR will verify the compliance of each employee with the qualification requirements appropriate to their employment category. The COR shall inform the Contractor of compliance of the qualification package or any discrepancies contained therein. The Contractor shall not assign an individual to work at the MTF until their CR has been approved and shall discontinue the service of an individual who fails to maintain compliance with qualification and credentialing requirements.

7.2. The contractor is responsible for prime source verification of all licenses and certifications prior to submission of the CR to the COR. The contractor shall provide written documentation from the verifying agency that includes the agency POC, their position and contact information, the agency name, and the date of verification. The contractor shall also include a copy of their outgoing letter to the primary issuing agency requesting written verification. Upon receipt by the contractor, the issuing agency's original letterhead verification response shall be provided to the MSSO, via the COR. Services shall not be performed until appropriate clinical privileges have been granted, or in the case of clinical support staff, credentials have been approved.

7.2.1. The contractor shall ensure that all documentation necessary to keep each individual CR current is submitted to the MSSO, via the COR, for inclusion in each file. The contractor shall maintain a complete credential file for each HCW during the life of this contract. It is emphasized that the file and the documents therein shall be kept current and shall be made available for Government inspection upon request if needed for further credential review.

7.3. Unless otherwise specified, the Government reserves the right to transfer to the gaining Contractor the credentials of a contractor’s employee who has been granted delineated clinical privileges on a predecessor contract/task order without a new or additional credentialing action. This extension may only occur: a) within the same command; b) when there is no increased clinical competency requirement of the contractor’s employee; c) when there is no significant change in the scope of clinical practice of the contractor’s employee; d) when there is no gap in performance between the contracts; and e) when the contractor’s employee has had acceptable performance evaluations.

7.4. Notwithstanding licensure and certification requirements given in DHA PM 6025.13, each contract employee is responsible for complying with all applicable licensure and certification regulations.

7.5. The privileging authority per DHA PM Number 6025-13 (and subsequent revisions) will grant clinical privileges where appropriate to those HCWs requiring privileges to perform services. If a HCW’s employment with the contractor ends for any reason, all clinical privileges and medical staff appointments shall be terminated without recourse to the fair hearing and appeals procedures specified by the medical staff bylaws and DHAPM number 6025.13, Volume 3 (and subsequent revisions).

7.6. Clinical Competency: Each HCW shall be required to demonstrate clinical competency within the past two years in the required clinical discipline as specified in this PWS.

7.7. The Contractor shall continuously maintain a current list of all individuals who have been privileged and credentialed for service under the contract, including reportables such as, but not limited to: flu shots, certifications (BLS, ACLS, PALS, etc.), licenses, and/or certification. The Contractor shall provide a copy of the updated list to the COR not later than the 3rd business day of each month, or more often as needed to keep the information current.

7.8. The Contractor shall inform the COR of any terminations of employment within 24 hours of the action.

7.9. The MTF will not credential more than seven (7) contract employees for this requirement.

7.10. Documentation containing HCW PII and/or HIPAA information shall be transmitted via encrypted email or through alternate secure means provided by the COR.

SECTION 8 - GOVERNMENT AND CONTRACTOR FURNISHED ITEMS.

8.1. GOVERNMENT FURNISHED ITEMS

8.1.1. The Government will provide, without cost, the facilities, badges and maintenance services, with the exception of intraoperative neurophysiologic monitoring system and supply maintenance, required to perform the duties of this Contract. Government furnished property will not be issued under this Contract.

8.1.2. Personnel background investigations must be initiated seven (7) calendar days after contract award and an advance fingerprint and NACLC results received by the MTF prior to a Common Access Card (CAC) being issued to Contractor personnel.

8.1.3. The Government will provide base access cards for all Contractor personnel to be used in accordance with base and MTF policy during the initial check-in procedure with the COR. Contractor personnel shall comply with the military base policies and instructions for gaining access to the military base. The identification badge shall be worn during performance of work and anytime Contractor personnel are on the premises. The Contractor shall ensure that each employee’s I.D. badge and CAC are returned to the COR when Contractor personnel are no longer providing services under this Contract due to termination/expiration of the contract.

8.2. CONTRACTOR FURNISHED ITEMS

8.2.1. INSURANCE. This is a non-personal service contract; therefore, the Contractor is required to have their own insurance.

8.2.1.1. AUTOMOBILE LIABILITY INSURANCE. Before commencing work under this Contract, the Contractor shall certify to the Contracting Officer in writing that the required automobile insurance has been obtained. The following insurance as referenced in Federal Acquisition Regulations (FAR) Clause 28.307, is the minimum insurance required: Automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing this Contract. Policies covering automobiles operated in the United States shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

8.2.1.2. WORKERS’ COMPENSATION AND EMPLOYER’S LIABILITY. The Contractor shall comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with the Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 shall be required, except in states with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

8.2.1.3. MEDICAL LIABILITY. The Contractor shall comply with applicable requirements of the FAR Clause 52.2377, Indemnification, and Medical Liability Insurance (JAN 1997).

8.2.1.3.1. The Contractor shall complete the Malpractice Insurance Certification Form, Attachment 5, as part of the Quote and shall provide an updated form to the COR upon request.

8.2.2. SERVICES

8.2.2.1. During the term of this Contract, Contractor personnel shall provide, on behalf of the Government, intraoperative neuromonitoring services to active duty military personnel, their dependents, eligible Navy civilian employees, and other eligible beneficiaries, in accordance with the terms and conditions of the contract.

8.2.3. EQUIPMENT

8.2.3.1. The Contractor shall acquire, maintain, and provide in good working order the dedicated equipment, technology, and software required to provide intraoperative neuromonitoring services. The costs of repair and/or replacement of such equipment, technology, or software will be the sole responsibility of the Contractor. The Contractor agrees to abide by the MTF’s policies and procedures regarding the maintenance, use, and safety of any clinical equipment utilized on-site at the MTF. The Contractor shall ensure full maintenance of all equipment used in conjunction of the requirements of this Contract. All maintenance records are to be written and available for review by the Government with a minimum five (5) calendar day advance notice.

8.2.4. SUPPLIES

8.2.4.1. The Contractor agrees to provide all supplies required to provide intraoperative neuromonitoring services. The Contractor’s price should be inclusive of all costs to include any required labor, transportation, and consumable items/supplies. The Government will not provide any consumable items/supplies that are required for the operation of Contractor’s equipment.

SECTION 9 – QUALITY CONTROL

9.1. QUALITY OF SERVICE. This is a non-personal services Contract that supports the MTF mission to oversee and coordinate the delivery of economical and effective medical, dental and other health care services. The intraoperative neuromonitoring services required by this Contract support the provision of patient care in the medical treatment facilities within the Area of Responsibility (AOR) and ensure services are available to beneficiaries. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

9.1.1. The Contractor shall comply with applicable provisions of the law, rules, and regulations of all governmental authorities, including but not limited to, the regulations and standards of the MTF. The Contractor shall adhere to and comply with all Defense Health Agency, Department of Navy (DON), Bureau of Medicine and Surgery (BUMED) and MTF Instructions and notices which may be in effect during the term of this Contract.

9.1.2. To achieve the MTF mission, the Contractor shall establish, submit for government approval, and implement a Quality Control Plan (QCP) which is consistent with the MTF Quality Control Program. The Contractor shall also actively participate in the established medical Quality Improvement (QI) Plan of the MTF. Current copies of this Contract, the Contractor’s QCP, and the MTF’s QI plan shall be maintained on-site for ready reference by the Contractor during the term of this Contract. Contract personnel shall read, be familiar with, and implement this Contract, including the Contractor’s technical approach, QCP, medical QI Plan, and any revisions.

9.1.3. After contract award, but not later than commencement of services, the contractor shall submit a Quality Control Plan to the COR and the Contracting Officer for review. The contractor’s QCP shall be consistent with Joint Commission standards and the MTF Quality Control Program. The QCP shall, at a minimum, include (a) a plan for providing services by appropriately qualified personnel that includes a specific methodology for doing so;

(b) a plan to ensure maintenance and enforcement of Standards of Conduct for contractor personnel as specified in Section 11.3 and (c) a plan for a patient relations program that is compliant with the MTF's patient relations protocols and which includes a notification process for all patient compliments and complaints.

9.1.4. Upon receipt of the Contractor's QCP, the MTF will review and provide comments to the Contractor. If the MTF finds deficiencies in any portion of the proposed QCP, the Contractor shall have five (5) business days to correct the deficiencies. The MTF COR will provide final approval of the QCP.

9.1.5. Sixty days prior to the start of a subsequent task order under this contract, issued annually based on the dates in the contract award, the contractor shall submit to the COR an updated QCP that is consistent with updated Joint Commission standards and updated MTF Quality Control Program. The revised QCP shall be subject to the same review process as that required at the time of contract award.

9.2. INDEPENDENT CONTRACTOR. The services provided by the Contractor are provided in the capacity of an independent contractor. The government will evaluate the quality of services for purposes of contract inspection and acceptance. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Contractor shall recognize that the Commanding Officer maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and U.S. Navy Regulations.

9.3. MODIFICATIONS. The Contracting Officer will designate and authorize an individual to act as the Contracting Officer's Representative (COR). Any such representative appointed will be specifically designated by letter from the Contracting Officer. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contractual modification or adjustment. Changes in the scope of work can only be made by modification properly executed by the Contracting Officer. All observations made by persons other than the Contracting Officer or the COR are strictly advisory and shall not influence the Contractor's operations except for administrative requirements and responsibilities specified herein.

SECTION 10 - START OF SERVICES

10.1. BACKGROUND INVESTIGATION

10.1.1. The Contractor Appointed Personnel shall report to the COR on the first day of contract performance. The COR or technical assistant (TA) shall provide direction for a proper check-in and any additional documentation or instructions that may be necessary for contract performance. The Contractor Appointed Personnel shall return the completed check-in sheet to the COR within ten (10) business days.

10.1.2. Upon receipt of an adjudicated Federal background investigation or at a minimum advanced fingerprint results, the Command Trusted Agent will enter Contractor personnel into the Contractor Verification System (CVS). Contractor personnel are responsible for completing the CVS application for requesting issuance of a Common Access Card (CAC).

10.1.3. Thirty (30) calendar days prior to performance of services under this Contract, the Contractor’s Security Representative shall submit to the MTF Security Manager via the COR the necessary documents to obtain the appropriate Federal background investigation.

10.2. OCCUPATIONAL HEALTH REQUIREMENTS

10.2.1. Within 60 days prior to performance of services by the contractor, the contractor shall obtain, at contractor expense, documentation of required immunizations and physical testing, and a statement from the contractor employee’s medical practitioner or a report of a physical examination. The physical examination and immunization documentation shall indicate that the contractor employee is free from mental or physical impairments that would restrict contract personnel from providing the services described herein. The requirements are provided on the HEALTH EXAMINATION AND IMMUNIZATION/SCREENING REQUIREMENT FORM, the current version of which is available at:

https://www.med.navy.mil/sites/nmlc/handbooks/Physical%20Exam%20and%20Immunization%20Form.pdf The Contractor shall always obtain the current version from the web page and shall have the form completed in its entirety in accordance with its instructions. The MTF will identify any contract personnel who are not required to complete this documentation after contract award. Declinations shall only be permitted based on either the contract personnel’s religious convictions or medical contraindications (as documented by a qualified health care provider).

The Hepatitis B vaccine declination can be found on the World Wide Web at http://www.osha.gov/SLTC/etools/hospital/hazards/bbp/declination.html.

10.2.1.1 Health Requirements - The Contractor shall comply with all health requirements in the contract. Prior to physical performance of services by personnel, at least 10 calendar days prior to start of work at the requesting location, but no more than 60 calendar days, the Contractor shall provide documentation certifying health requirements such as immunizations, annual vaccinations, medical testing (i.e., tuberculosis, N95 particulate respirator duckbill mask fitting) and physical examination when required at the time of initial placement and annually thereafter, as required. The expense for all health requirements, to include monitoring and tracking annual requirements, shall be borne by the Contractor at no additional cost to the Government.

10.2.1.2. Annual Immunizations. The Contractor shall ensure contract personnel are immunized annually with the seasonal influenza vaccine and any other vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) for health care workers or service/MTF specific requirements.

10.2.1.2.1. Immunization Tracking. The Government may track immunizations information in a DoD computer system for all personnel. The Contractor shall maintain their own process and system of tracking the currency of health immunizations and shall not rely on the Government for ensuring their employees are in compliance.

10.2.1.2.2. Tuberculosis. On the occasion where there is a higher risk of transmission of tuberculosis, MTF policy may direct personnel be tested more frequently at no cost to the government.

10.2.1.2.3. Medical Tests. The MTF will not perform any medical tests or procedures required by the contract for non-beneficiaries except in the rare case of post-exposure IAW Air Force, DoD and CDC guidelines or recommendations. Except in the case of post-exposure, expenses for all required tests and/or procedures shall be borne by the contractor management staff or personnel, not the government.

10.2.1.2.4. Health Notifications. Contractor management staff shall inform the government if contractor personnel report any medical conditon to the contractor management staff. The government will notify the contractor management staff of any work hazards in accordance with BUMED Instruction 6570.3A CH-1. If work hazards exist, it will be the government’s decision whether the worker continues work in the environment and/or if temporary accommodations can be made.

10.2.2. BLOOD-BORNE PATHOGEN ORIENTATION PROGRAM. Contract personnel shall participate in the MTF’s Blood-borne Pathogen Orientation Program. Contract personnel shall also participate in all required annual training and in periodic training for all procedures that have the potential for occupational exposure to blood-borne pathogens.

10.2.2.1. All contract personnel shall comply with infection control guidelines to include the proper handling, storage, and disposal of infectious wastes and the use of universal precautions to prevent the spread of infections.

10.2.3. MANAGING THE CLINICAL RISK IN THE WORK ENVIRONMENT. The work environment inherently involves risks typically associated with the performance of job duties. The Contractor personnel may be exposed to contagious diseases, infections and flying debris, requiring the wearing of personal protection equipment such as scrub attire, gloves, masks, and eye protection.

10.2.3.1. In the event of an exposure, the Contractor and the MTF will cooperate, in accordance with applicable MTF policy, regarding offering appropriate post-exposure testing to the affected contract personnel and the MTF will use its best efforts to appropriately test the source patient and obtain the patient’s consent to disclose the test results to Contractor personnel and the Contractor. The Contractor will be responsible for providing appropriate follow-up medical care and counseling, if applicable, and record-keeping.

10.2.3.2. Contractor personnel with a bona fide medical emergency occurring while on duty, or with an on-the-job injury, will be provided stabilizing medical care according to the procedures of the MTF. The Contractor shall reimburse the government for all medical services provided unless the Contractor personnel are otherwise entitled to government medical services.

10.2.3.3. All accidents which may arise out of or in connection with the performance of services required herein, and which result in injury, death or property damage, shall be reported to the Safety Department and the COR immediately and to the MTF QI Department within 24 hours. Verbal reports shall be followed by written reports within 24 hours. Statements of witnesses shall be included. If any claim is made by a third party against the Contractor on account of any accident which occurs in connection with the performance of this Contract, the Contractor shall promptly report the facts in writing to the Command Legal Advisor, the MTF QI Department, the Command Safety Department, and the COR.

10.3. ORIENTATION

10.3.1. All contract personnel providing service under this Contract shall undergo an orientation. On a case-by-case basis, the government may waive orientation sessions if the contract personnel are currently or have previously worked at the MTF.

10.3.2. Orientation shall be provided in conjunction with scheduled procedures. The hospital orientation will include familiarization with the facility complex, introduction to command rules and regulations, safety and fire regulations, introduction to military protocols such as military structure, time and rank, acquisition of parking permits and clarification of rights and responsibilities. Orientation will also include any familiarization with applicable departmental policies, rules, and regulations.

10.3.3. Orientation is conducted in conjunction with regular scheduled procedures during normal hours of operation 0700 to 1700 hours Monday thru Friday. Orientation shall be completed within sixty (60) days of the contract personnel start date.

10.3.4. The Contractor shall not bill separately for orientation. All expenses related to orientation shall be included in the per procedure rates.

10.4. EMERGENCY PREPAREDNESS PLAN

10.4.1. Contract personnel shall participate in executing the Emergency Preparedness Plan (drills and actual emergencies) as scheduled by the MTF (typically semiannually). The MTF maintains a personnel re-call list with personal contact information for all military, civil service and contract personnel which is required, to prepare in advance, for an actual emergency. Upon commencement of performance, the contractor shall provide the COR with a list of personal contact information for a designated contractor representative as well as all contractor staff performing services. Should an emergency occur that will affect the workers’ shifts, the designated contractor representative and the contract personnel will be contacted.

SECTION 11 – STANDARDS

11.1. STADARDS OF CONDUCT

11.1.1. Contractor employees providing support to the Government shall conduct themselves in a professional, businesslike manner adhering to high ethical standards. Contractor employees must follow the Standards of Ethical Conduct for Employees of the Executive Branch (Codified in 5 C.F.R. Part 2635 and as amended at 76 FR 38547) and local command policy in addition to the standards of conduct policies of the contractor. The Government will not tolerate unethical behavior and behavior that reflects poorly upon the Government, its mission, and its operations. If a contractor employee is uncertain whether contemplated acts or conduct may violate the Standards of Ethical Conduct for Employees of the Executive Branch or local command policy, the contractor employee must contact the Contracting Officer Representative (COR) before engaging in such acts or conduct. CORs will seek advice on ethics issues from their ethics counselor.

11.2. OTHER REQUIREMENTS

11.2.1. All financial, statistical, personnel, and technical data which are 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 work under this contract. Such data shall not be released by the contractor without prior written consent of the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from studies covered by this contract, will be subject to review and approval by the Commanding Officer via the COR before publication or dissemination. Neither the contractor nor contractor employees shall make any disclosure regarding the contract, the MTF or MTF patients, employees or staff members without prior approval of the Commanding Officer via the COR. All inquiries from the media shall be forwarded to the Command Public Affairs Officer via the COR. Before advertising services or disseminating promotional materials, the Contractor shall seek approval in accordance with MTF procedures.

11.2.2 All records produced in the performance of this Contract and all evaluations of patients are the property of, and subject to the exclusive control of, the government. The Contractor may retain a copy of all such records or evaluations, but may not provide further copies or disclose the information from such records or evaluations to third parties. All requests from other treatment facilities or other individuals for patient records shall be handled in accordance with procedures specified by applicable MTF instructions.

11.3. CONTRACT PERSONNEL STANDARDS

11.3.1. The Contractor and all Contractor personnel shall comply with all MTF checkout processes. These processes include returning government property, i.e., identification badges, pagers, cellular phones, etc., to the MTF upon Contractor personnel’s last day of service. Failure to do so promptly may result in delay of payment to the Contractor.

11.3.2. Eating by Contractor personnel is prohibited in patient care areas/clinics and is restricted to designated areas. Smoking is prohibited in all clinic facilities.

11.4. CONFLICT OF INTEREST

11.4.1. The Contractor shall not, while performing services under this Contract, advise, recommend, or suggest to persons eligible to receive medical care at the government’s expense that such persons should receive care from the Contractor at any place other than a government facility.

SECTION 12 - DEFINITIONS

ACTIVE DUTY MEMBER: Full-time duty in uniformed service of the United States, including the United States Navy. This includes full-time training duty, annual training duty, and attendance while in the active service at a school designated as a service school by law or by the Secretary of the Military Department concerned. It does not include full-time National Guard duty.

COMMANDER/COMMANDING OFFICER: The individual naval officer who has responsibility for the operation of the medical treatment facility (MTF) for which the contract services are provided.

CONTRACTING OFFICER: The government employee responsible for negotiating changes in terms, conditions, or amounts cited in this Contract.

CONTRACTING OFFICER'S REPRESENTATIVE (COR): The government employee responsible for assuring the Contractor’s performance through audit, documentation, and liaison with the Contracting Officer. The COR is appointed in writing by the Contracting Officer. The COR has no authority to resolve disputes or obligate funds.

CONTRACT PERSONNEL: For the purpose of this Contract, “contract personnel” means an individual employed by the prime or subcontractor.

CONTRACTOR: That entity or its representative responsible for the delivery of the services or materials specified in this contract, as designated by contract award.

DOCUMENT (verb): To completely, accurately, and legibly record information, using prescribed forms or a computer terminal, as appropriate.

EQUIPMENT: A moveable object, such as a typewriter which is used to perform a procedure(s) that results in a work product.

JOINT COMMISSION: A national organization dedicated to improving the care, safety, and treatment of patients in healthcare facilities; publishers of the Joint Commission Accreditation Manual for Hospitals and the Ambulatory Healthcare Standards Manual.

KEY PERSON: A skilled and experienced professional and/or technical person who is essential for successful accomplishment of the work to be performed under this Contract.

MAINTENANCE: The upkeep of buildings, fixtures, furniture, and/or equipment that is required to keep these items fully functional and/or to produce an acceptable level of performance or quality of operation.

MEDICAL TREATMENT FACILITY (MTF): Unless otherwise specified, "the MTF" refers to the Naval MTF at which services are being performed under this Contract. The MTF includes all activities providing outpatient and/or inpatient health services for eligible beneficiaries.

PERFORMANCE IMPROVEMENT (PI): An ongoing program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

PROTOCOLS: Written procedures providing basic guidelines for the management of specific types of situations related to medical patients, healthcare personnel, and/or medical treatment facilities (MTF's).

TECHNICAL ASSISTANT (TA): The MTF representative who may be assigned by the COR to provide technical or administrative assistance to the COR. TAs may be assigned to assist and support the COR but will not be given the authority to provide any technical direction or clarification directly to the Contractor.

QUALITY ASSURANCE (CONTRACT): Those actions taken by the government to check goods or services to determine that they meet the requirements of this Contract.

QUALITY CONTROL: Those actions taken by the Contractor to control the provision of services so that they meet the requirements of the Performance Work Statement.

QUALITY IMPROVEMENT (MEDICAL): An ongoing program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

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