Clinical Consultation AIRO Statement of Work.pdf

STATEMENT OF WORK

Intraoperative Neuro-navigation Consultation Services Naval Medical Center San Diego, CA

SECTION 1 – SCOPE

1.1. BACKGROUND

The Contractor shall provide non-personal intraoperative neuro-navigation consultation services for Naval Medical Center San Diego, CA (hereafter referred to as “NMCSD” and/or “MTF”) for surgical cases requiring intraoperative neuro-navigation. Service is required for a variety of cranial and spine surgical cases. Note this is not an exhaustive list meant to limit the type of service provided. This list is provided for informational purposes only. This Contract is a non-personal health care services contract, under which the Contractor is an independent contractor and services will be limited to training and guidance of the BrainLab Curve Navigation System and Ario Mobile CT Scanner.

1.2. SCOPE

The Contractor shall provide intraoperative neuro-navigation consultation services for the Main Operating Room (MOR) on 1-4 at the MTF, located at 34800 Bob Wilson Drive, San Diego, CA 92134-5000.

SECTION 2 - DUTIES

2.1. GENERAL DUTIES

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.

Function with an awareness and application of safety procedures.

2.1.2.

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

2.2. SPECIFIC DUTIES FOR PROVIDING INTRAOPERATIVE NEURO-NAVIGATION SERVICES

2.2.1.

The Contractor shall provide intraoperative neuro-navigation consultation services on an as needed basis. Services required include education and training to surgeons and hospital personnel on BrainLab Curve neuro-navigation and mobile Airo CT equipment, provide on-site guidance and assistance during surgery and diagnostic use of the neuro-navigation equipment as needed, provide guidance to radiology staff regarding scan protocols to perform any required pre-operative MR scans that can merge with intraoperative CT data acquired with Airo, and develop and conduct training programs for hospital staff to allow for in-house training. 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. Procedures are scheduled during the hours of 0700 and 1700 Monday through Friday (normal operating hours), exclusive of Federal holidays. The Contractor 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. The Government will provide a list of scheduled procedures to the contractor approximately fourteen (14) days prior to the requirement for service. The contractor shall recognize that the schedule provided may change within that timeframe. The Contractor shall be responsible for providing a toll-free number where requests for services can be communicated to a live person with a confirmation number communicated to the Government.

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 Government will provide notification no more than 48 hours in advance of the need for an emergency procedure. The Contractor shall be responsible for providing a toll-free number where requests for services can be communicated to a live person with a confirmation number communicated to the Government.

2.2.2.

The Contractor shall promote quality patient care by coordinating training and guidance on range of capabilities of neuro-navigation equipment and mobile CT scanner in collaboration with multidisciplinary and interdepartmental personnel.

2.2.3.

The Contractor shall demonstrate detailed technical knowledge and troubleshooting ability for the intraoperative neuro-navigation system and mobile CT scanner.

2.3. EQUIPMENT AND SUPPLIES

2.3.1.

NMCSD shall furnish all equipment and supplies necessary to operate the intraoperative neuro-navigation system and mobile CT scanner.

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 - QUALIFICATIONS

4.1. GENERAL QUALIFICATIONS THAT APPLY TO ALL CONTRACTORS

4.1.1.

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. The services require that Contractor personnel possess the following minimum qualifications to meet the requirements of this Contract.

4.1.2.

Contract employees shall maintain current certification in Basic Cardiac Life Support (BCLS). Training shall be the responsibility of the Contractor and is at no cost to the government. Contract employees, 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 BCLS instruction may be obtained from the World Wide Web at:

http://www.med.navy.mil/directives/ExternalDirectives/1500.15E.pdf.

4.1.3.

Be a U.S. Citizen per Attachment II.

4.1.4.

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

4.2. SPECIFIC QUALIFICATIONS FOR PERSONNEL PROVIDING INTRAOPERATIVE NEURO-

NAVIGATION CONSULTATION SERVICES

Contractor shall be responsible for determining the specific labor category necessary to provide the services described herein; however, the following qualifications are required:

4.2.1.

The Contractor must be a certified BrainLab consultant

4.3. SPECIFIC KNOWLEDGE FOR PERSONNEL PROVIDING INTRAOPERATIVE NEUROMONITORING

SERVICES

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

4.3.1.

Knowledge of capabilities and operation of the BrainLab Curve Navigation system and the Airo Mobile CT Scanner.

4.3.2.

Knowledge of scan protocols and safe use of Airo Mobile CT Scanner.

4.3.3.

Knowledge of safety and environment of care procedures.

4.3.4.

Knowledge and expertise in on required pre-operative MR scans that can merge with intraoperative CT data acquired with the Airo Mobile CT Scanner.

4.3.5.

Knowledge of developments in the field of Intraoperative Neuro-navigation.

SECTION 5 - GOVERNMENT AND CONTRACTOR FURNISHED ITEMS.

5.1. GOVERNMENT FURNISHED ITEMS

5.1.1.

The Government will provide, without cost, the facilities, badges, and maintenance services required to perform the duties of this Contract. Government-furnished property shall only be used in the performance of this Contract.

5.1.2.

A Common Access Card (CAC) will only be issued to Contractor personnel who may require access to a Government computer. To gain access to the Government installation, the use of the DBIDS system is suggested.

Commander, Navy Installations Command (CNIC), has established the Navy Commercial Access Control System (NCACS), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter Navy installations and facilities. Vendors visiting Naval Medical Center (NMC) San Diego, CA may obtain daily passes by submitting identification credentials for verification and undergoing a criminal screening/ background check. Alternatively, if the vendor so chooses, it may voluntarily elect to obtain long-term credentials through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own cost through one of the designated independent contractor NCACS service providers. Credentials will be issued every year and access privileges will be reviewed / renewed on an annual basis. The costs incurred to obtain Navy installation access of any kind are not reimbursable, and the price(s) paid for obtaining long-term NCACS credentials will not be approved as a direct cost of this contract. Further information regarding NCACS can be found at http://cnic.navy.mil/CNIC_HQ_Site/index.htm.

5.1.3.

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 is returned to the COR when Contractor personnel are no longer providing services under this Contract due to termination/expiration of the contract.

5.1.4. EQUIPMENT

5.1.4.1.

The Government shall acquire, maintain and provide in good working order the dedicated equipment, technology and software required to provide intraoperative neuro-navigation services. The costs of repair and/or replacement of such equipment, technology or software will be the sole responsibility of the Government.

5.1.5. SUPPLIES

5.1.5.1.

The Government agrees to provide all supplies required to provide intraoperative neuro-navigation services.

5.2. CONTRACTOR FURNISHED ITEMS

5.2.1. INSURANCE

This is a non-personal service Contract, so the Contractor is required to have their own insurance.

5.2.1.1. 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.

5.2.1.2. 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.

5.2.1.3. MEDICAL LIABILITY

The Contractor shall comply with applicable requirements of the FAR Clause 52.237-7, Indemnification and Medical Liability Insurance (JAN 1997).

5.2.1.3.1.

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

5.2.2. SERVICES

5.2.2.1.

During the term of this Contract, Contractor personnel shall provide, on behalf of the Government, intraoperative neuro-navigation consultation 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.

SECTION 6 – QUALITY CONTROL

6.1. 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 neuro-navigation consultation 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 professional aspects of services rendered.

6.1.1.

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 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.

6.2. 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.

6.3. 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 7 - START OF SERVICES

7.1. OCCUPATIONAL HEALTH REQUIREMENTS

7.1.1.

The requirements are provided on the HEALTH EXAMINATION AND IMMUNIZATION/SCREENING REQUIREMENT FORM, the current version of which is available at:

http://www.med.navy.mil/sites/nmlc/Public_Docs/Physical%20Exam%20and%20Immunization%20Form.pdf. This form shall be completed after award for all Contractor personnel providing services under this Contract and provided at least thirty (30) calendar days prior to performance start date. The MTF will identify any Contractor personnel who are not required to complete this documentation after contract award. Declinations shall only be permitted based on either Contractor personnel religious convictions or medical contraindications (as documented by a qualified health care provider).

7.1.2. BLOOD-BORNE PATHOGEN ORIENTATION PROGRAM

Contract employees shall participate in the MTF’s Blood-borne Pathogen Orientation Program. The contract employee 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.

7.1.2.1.

All contract employees 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.

7.2.3. 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.

7.2.3.1.

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 employee 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.

7.2.3.2.

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.

7.2.3.3 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.

7.3. EMERGENCY PREPAREDNESS PLAN

7.3.1.

Contract employees 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 employees 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 employees will be contacted.

SECTION 8 - STANDARDS

8.1. STANDARDS

8.1.1.

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 COR before publication or dissemination. All inquiries from the media shall be forwarded to the Command Public Affairs Officer via the COR.

8.1.2.

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.

8.2. CONTRACT EMPLOYEE STANDARDS

8.2.1.

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.

8.2.2.

Eating by Contractor personnel is prohibited in patient care areas/clinics and is restricted to designated areas.

Smoking is prohibited in all clinic facilities.

8.3. CONFLICT OF INTEREST

8.3.1.

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 9 - 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 EMPLOYEE: For the purpose of this Contract, “contract employee” 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 ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS (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.