Statement of Work (SOW) BrainLab Clinical Intraoperative Support.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 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.

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 preform 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 instruction.

2.2. SPECIFIC DUTIES FOR PROVIDING INTRAOPERATIVENEURO-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, 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 CT, 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 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 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 (BLS).

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 bases classes do not meet these standards. A copy of the

BLS instruction may be obtained from the World Wide Web at:

https://www.med.navy.mil/Portals/62/Documents/BUMED/Directives/Instructions/1500.15F.pdf

?ver=MjOk1r_3tLS1sMcuf12-zQ%3d%3d

4.1.3.

Be a U.S. Citizen.

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-NAVIGATIONS 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 Brain LAB consultant

4.3. SPECIFIC KNOWLEDGE FOR PERSONNEL PROVIDING INTRAOPERATIVE

NEUROMONITORING SERVICES

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

4.3.1.

https://www.med.navy.mil/Portals/62/Documents/BUMED/Directives/Instructions/1500.15F.pdf?ver=MjOk1r_3tLS1sMcuf12-zQ%3d%3d https://www.med.navy.mil/Portals/62/Documents/BUMED/Directives/Instructions/1500.15F.pdf?ver=MjOk1r_3tLS1sMcuf12-zQ%3d%3d

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 through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own costs through one of the designated independent contractor NCACS service provides. 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 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 bae. 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 service.

The costs of repair and/or replacement of such equipment, technology or software will e 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.

5.2.2. 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.

SECTION 7 - START OF SERVICES

7.1. OCCUPATIONAL HEALTH REQUIREMENTS

7.1.1.

The requirements are provided by the Occupational Health Office on the contractor check in form provided by the Human Resources office. This form shall be completed after award for all

Contractor personnel providing services under this Contract. 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).

- End of Statement of Work -