N6890819Q0062_-_Lithotripsy_Services_PWS.pdf

N6890819Q0062

Performance Work Statement Lithotripsy Services

Naval Hospital Pensacola, FL

SECTION 1 – SCOPE

BACKGROUND

The Contractor shall provide Mobile Lithotripsy services to include management, staffing, Lithotripsy equipment, supplies and support personnel for Naval Hospital Pensacola, FL (hereafter referred to as “the MTF”) for a base plus 1 option year effective 01 September 2019. The Contractor shall provide a transportable lithotripsy for the treatment of active duty military personnel, their dependents, eligible DOD civilian employees, and other eligible beneficiaries designated by the government. Services are required one day per month. The services shall meet the guidelines for TRICARE/DoD access standards.

SECTION 2 - DUTIES

2.1. SPECIFIC DUTIES FOR LITHOTRIPSY SERVICES

The contractor shall provide non-invasive surgical procedures for treatment of kidney stones using an Extracorporeal Shock Wave Lithotripsy (ESWL) technique with the specified equipment.

2.1.1.

The contractor shall provide the Mobile Lithotripsy System and radiologic technologist personnel to perform lithotripsy procedures as needed within 24 hours of notification, generally on a Thursday. The Government will coordinate a delivery schedule with the contractor one month in advance for each 1-month period. The MTF anticipates approximately 5 procedures per month. The Contractor shall be compensated per procedure in accordance with Schedule B with a minimum of one procedure for every scheduled visit.

2.1.2.

The Government will schedule appointments for lithotripsy service and confirm patient appointments not less than 48 hours prior to performance of the procedure.

2.1.3.

Upon each scheduled visit, the Contractor shall deliver, set-up, shut-down, and remove the Lithotripsy System and shall complete the manufacturer routine quality control procedures for the unit. The Government will schedule a Biomedical Technologist inspection to be performed prior to every scheduled visit. The contractor shall arrive one hour prior to the scheduled procedure to coordinate.

2.1.4 The Government will perform all pre- and post-procedure duties, including escorting the patient to and from the MTF’s waiting area and procedural location (e.g., MTF’s main operating room or ambulatory procedure unit).

2.1.5.

The Contractor personnel shall operate the lithotripsy unit and related equipment independently and under the technical direction of the Government Urologist. The Contractor personnel shall recognize the need for and institute emergency measures should a patient require resuscitation procedures.

2.1.6.

Contractor employees shall demonstrate sufficient initiative, interpersonal relationship skills and social sensitivity such that they can relate constructively to a variety of patients and staff from diverse backgrounds.

2.1.7.

Contractor Personnel shall report to the COR on the first day of contract performance. The COR shall provide a copy of the MTF’s Performance Improvement plan, direction for a proper check-in, and any additional Documentation or instructions that may be necessary for contract performance. The Contractor Personnel shall return the completed check-in sheet to the COR within three (3) business days.

2.2 REPORTS

2.2.1.

The government will monitor success of performance of the Mobile Lithotripsy Service via submitted reports, internal ad hoc reporting capabilities, beneficiary feedback, peer reviews, and ongoing monitoring by Government surveillance personnel.

SECTION 3 – HOURS OF OPERATION

3. 1.

The contractor shall normally provide Lithotripsy services one Thursday per month, between 0700 to 1600 hours (7:00am to 4:00pm). The contractor will not be required to provide services on Federal holidays. Specific periods will be determined by the government based on workload trends and mission requirements. Specific schedules for the contractor employee shall be coordinated with the Department Head 30 days in advance.

Any changes in the schedule shall be provided to the Department Head a minimum of 2 weeks in advance. In case of urgent ESWL the vendor shall be on-site within a 24 hours’ notice.

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 notified by the COR that a closing due to weather conditions or other emergency is authorized The Contractor will receive guidance from the COR of the MTF protocol for closings.

SECTION 4 – DELIVERABLES

4.1. Quality Control Program (See Section 9)

4.2. Health Certifications for Employees (See Section 6)

4.3. The deliverables required will be assessed against the specifications for the deliverables detailed in the contract/task order(s) and the Quality Control Plan (QCP), if required by the contract, for the required content, quality, timeliness, and accuracy.

SECTION 5 – PERFORMANCE

5.1. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) MATRIX

PERFORMANCE

STANDARD

DELIVERABLE OR

SERVICE

REQUIREMENT

METHOD OF

SURVEILLANCE

MEASUREMENT/

METRIC

ACCEPTABLE

QUALITY LEVEL

(COR will monitor)

Proof of Equipment 7.1 Yearly records Measure timeliness 100% Property Damage review of initial submittal and updated certification at the start of every option year

Malpractice Certification

7.2.6.1. Yearly records

review

Measure timeliness of initial submittal and updated certification at the start of every option year

100%

QC Program 8.2.3.

Yearly records review

Measure timeliness of initial submittal and updated QC Program 60 days prior to every option year

100%

Provide supporting personnel that meet at least the minimum qualification

6.4 Initial records

approval

Measure quality of personnel

100%

Provide contractor employees qualification packages 15 days prior to performing services

6.2 Initial records

approval

Measure timeliness of packages for new contract employees

100%

Provide monthly list of qualified and MTF approved personnel

6 Initial records approval

Measure timeliness of packages for new contract employees

100%

Timely delivery and equipment set-up

7.2.4 Random record

check, peer review

Measure timeliness of equipment delivery and set-up prior to patient procedure

100%

Equipment approval by MTF’s Biomed Department

2.1.3.

Monthly records review, peer review

Measure quality and reliability of equipment

100%

Provide patient quality care

9.2 Peer review and

patient feedback

Measure quality of patient care

100%

SECTION 6 - QUALIFICATIONS

6.1. SPECIFIC QUALIFICATIONS FOR RADIOLOGIC TECHNOLOGIST SERVICES

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 contract employees possess the following minimum qualifications to meet contract requirements.

6.2.

Contract employees 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 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 BLS instruction may be obtained from the World Wide Web at: https://www.med.navy.mil/directives/ExternalDirectives/1500.15F.pdf.

6.3.

Be a U.S. Citizen. https://www.uscis.gov/i-9-central/acceptable-documents.

6.4.

Graduation from a radiologic technologist education program accredited by the Joint Review Committee on Education in Radiologic Technology (JCERT)

6.5.

Current registration by the American Registry of Radiologic Technologist (ARRT) as a Registered Technologist.

6.6.

A minimum of 1 year of full-time experience within the preceding 3 years in a similar setting to include experience in providing lithotripsy services.

6.7.

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

SECTION 7 - GOVERNMENT AND CONTRACTOR FURNISHED ITEMS.

7.1. GOVERNMENT FURNISHED ITEMS

7.1.1.

The Government will provide, without cost, the facilities, materials, consumable supplies, utilities from existing sources, equipment and maintenance services required to perform the duties outlined, with the exception of the Lithotripsy service required under this contract. Government-furnished property shall only be used in the performance of this contract. The Government will provide routine scheduled maintenance and repair of Government-provided equipment according to MTF Instructions. Upon Contractor’s request, through the COR, the Government will provide repairs of Government provided equipment in accordance with treatment facility instructions.

7.1.2.

The Government will furnish the buildings/areas (facilities) for the placement and operation of the Mobile Lithotripsy System. The designated area will be located in the Operating Room of the MTF. Approximately 500 square feet within the MTF will be provided for the services. The designated area is subject to change based on clinical workload.

7.1.3. No alterations to the facilities shall be made without specific written permission from the Contracting Officer.

http://www.med.navy.mil/directives/ExternalDirectives/1500.15C.pdf https://www.uscis.gov/i-9-central/acceptable-documents

At the time of contract completion or termination, the Contractor shall return the facilities in the same condition (quality and quantity) as received, fair wear and tear excepted.

7.1.4.

The Contractor shall requisition consumable supplies and equipment according to MTF procedures. The Contractor is liable for loss of or damage to supplies and equipment if such loss or damage is due to negligence or willful misuse. The Contractor shall ensure efficient and economical use of supplies.

7.1.5.

At no time during the term of this contract shall the Contractor remove Government furnished supplies or equipment from the MTF facilities.

7.1.6.

A Common Access Card (CAC) is required to perform contract services. The Government will provide a CAC to all eligible contract employees that successfully complete the access and security requirements. The contract employee shall comply with the MTF policies and instructions associated with processing a CAC.

7.1.6.1.

Personnel background investigations must be initiated within seven (7) days after contract award. Advanced fingerprint and NACLC results must be received by the MTF prior to a Common Access Card (CAC) being issued to the contract employees.

7.1.7.

The Government will provide base access cards for all contract employees during the initial check-in procedure with the COR to be used in accordance with base and MTF policy. The contract employees 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 the contractor is on the premises. The vehicle decal shall be displayed appropriately according to the base instruction. The contractor shall ensure that each employees I.D. badge and base vehicle decal are returned during a proper check-out with the COR when the contract employee is no longer providing services under this contract due to termination/expiration of the contract.

7.2. CONTRACTOR FURNISHED ITEMS

7.2.1 SUPPLIES. The Contractor shall furnish all supplies, except those listed as Government-furnished, required to perform the services described in this contract.

7.2.2 EQUIPMENT. The Contractor shall furnish a Mobile Lithotripsy System and all related equipment and supplies necessary to provide lithotripsy services. Program shall interface with CHCS and AHLTA or such provisions shall be made to ensure lithotripsy information is accurately entered into the CHCS and AHLTA systems.

7.2.2.1 The lithotripsy equipment shall contain the following minimum specifications: a shockwave generator, radiographic/fluoroscopic C-arm unit, and patient table. All components shall be mobile. The generator shall be FDA approved for treatment of both renal and urethral stones. The patient table shall be adjustable in multiple directions.

The generator should have a voltage range up to at least 22 kV.

The Government preferred lithotripsy equipment uses spark-gap technology with 22-24 KV range that is FDA approved for renal/urethral stones, C-arm fluoroscopy and digital imaging, minimum 30 KW generator, and 4-way position-able treatment table.

7.2.2.2 The contractor shall be responsible for all maintenance or repairs necessary to the equipment.

7.2.3. Software Upgrades. The Contractor shall provide all necessary software, licenses, and software upgrades for usage with the equipment.

7.2.4 Equipment Delivery and Set/up removal: The Contractor shall arrange for all transportation, delivery, and set-up/removal of equipment for each scheduled visit. The Contractor shall be responsible for all on-site and off-site transportation and transfer costs associated with the equipment. Prior to every scheduled visit, the lithotripsy equipment shall be inspected and approved by the MTF’s Biomed department as part of the equipment set-up procedure.

7.2.5. INSURANCE

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

7.2.5.1. AUTOMOBILE LIABILITY INSURANCE.

Before commencing work under a 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 FAR 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 the 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.

7.2.5.2. WORKERS’ COMPENSATION AND EMPLOYER’S LIABILITY

Contractors are required to 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 a 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.

7.2.6. MEDICAL LIABILITY

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

7.2.6.1.

The Contractor shall maintain malpractice insurance in accordance with the terms and conditions of this solicitation (including FAR Clause 52.237-7, Indemnification and Medical Liability Insurance). Contractor shall provide proof with their quote and provide an updated copy to the COR upon request.

SECTION 8 – QUALITY CONTROL

8.1. GENERAL

The Contractor shall complete all necessary steps to assist each contract employee performing services under this contract in obtaining documentation required to obtain access to the MTF and DoD information systems.

8.2. QUALITY OF SERVICE

This is a non-personal services contract that supports the U.S. Naval Hospital Pensacola’s mission to oversee and coordinate the delivery of economical and effective health care services. The lithotripsy services required by the contract support the provision of patient care in the medical treatment facilities within the Area of Responsibility (AOR) and ensure lithotripsy services are available to beneficiaries of the U.S. Naval Hospital Pensacola.

8.2.1.

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 the contract.

8.2.2.

To achieve the U.S. Naval Hospital Pensacola’s mission, the contractor shall establish, submit for Government approval and implement a Quality Control (QC) Plan 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 QC plan, and the MTF’s QI plan shall be maintained on-site for ready reference by the contractor during the term of the contract. Contract employees shall read, be familiar with, and implement the contract, including the contractor’s technical proposal, QC Plan, medical QI Plan, and any revisions.

8.2.3.

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 for the required hours 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 employees as specified in Section 11.2; 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.

8.2.4.

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 5 working days to correct the deficiencies. The MTF COR will provide final approval of the QCP.

8.2.5.

Sixty days prior to exercising any option year under this contract, 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.

8.3. 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.

8.4. 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 9 - START OF SERVICES

9.1 The Contractor shall recognize the importance of a successful start-up of contract services and the timely recruitment of qualified personnel to meet all contract requirements.

9.2. BACKGROUND INVESTIGATION

9.2.1. CRIME CONTROL ACT OF 1990 REQUIREMENT

9.2.1.1.

Section 21 of the Crime Control Act of 1990, 42 U.S.C. 13041, as amended by section 1094 of Public Law 1-02- 190, requires every facility operated by the Federal Government (or operated under contract with the Federal Government) that hires (or contracts to hire) individuals involved in the provision of child care services to assure that all existing and newly-hired employees undergo a criminal background investigation. The term "child care services" is defined to include health and mental health care.

9.2.1.2.

In accordance with 42 U.S.C. 13041(d) the Contractor shall ensure that employment applications for potential contract employees contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child, and if so, requiring a description of the disposition of the arrest or charge. The application shall further state that it is being signed under penalty of perjury, with the applicable Federal punishment for perjury stated on the application.

9.2.1.3.

The Government will conduct criminal background investigations for all potential contract employees who will be providing child care services under this contract based on fingerprints obtained by a Government law enforcement office (e.g., local, state, federal, etc.) and a completed SF 86 form (Questionnaire for National Security Positions ).

9.2.1.4.

The COR will identify the appropriate Navy Component for billing purposes and the appropriate security point of contact and/or installation Commanding Officer who will receive the background results.

9.2.2. PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL

9.2.2.1.

The Homeland Security Presidential Directive dated 27 August 2004 requires a mandatory government-wide standard for secure and reliable forms of identification for Federal employees, Contractors and contract employees who access federally controlled facilities or have access to Federally controlled IT systems. See Section I of this contract, FAR 52.204-9 for additional information.

9.2.3. Medical Contractor Access to Federally Controlled Facilities and/or Unclassified Sensitive Information or Unclassified IT Systems (DEC 2011). This clause applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to Privacy Act information on a DoD computer/network. It is the responsibility of the command/facility where the work is performed to ensure compliance. Each contract health care worker providing services at a Navy command under this contract is required to obtain a Common Access Card. Additionally, depending on the level of computer/network access, that contract health care worker will also require a successful investigation as detailed below.

9.3. CONTRACTOR’S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor’s Security Representative. Within three work days after contract award, the contractor shall provide to the Navy Command’s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor’s Security Representative. The Contractor’s Security Representative shall be the primary point of contact on any security matter. The Contractor’s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer.

9.4. ACCESS TO FEDERAL FACILITIES

Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 – “DoD Implementation of Homeland Security Presidential Directive – 12 (HSPD- 12)” dated November 26, 2008 (or its subsequent DOD instruction) and Navy implementing memorandum dated May 28, 2010 direct implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives. Per HSPD-12 and implementing guidance, all contract health care workers working at a federally controlled base, facility or activity under this clause will require a Common Access Card.

9.5. ACCESS TO DOD SYSTEMS

In accordance with SECNAV M-5510.30, contractors who require access to DOD networks are categorized as IT-I, IT-II, or IT-III. This clause applies to contractors who require IT-II privileged access to a DoN or DoD unclassified computer/network; the IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI) . All contract health care worker positions under this contract require access to Privacy Act protected information and are therefore categorized as no lower than IT-II.

9.6. PROCEDURES

To obtain a favorable determination, each contractor employee must have a favorably completed National Agency Check with Local Credit Checks (NACLC) which consists of a NACI including a FBI fingerprint check plus credit and law enforcement checks. Each contractor employee is required to complete:

• SF-86 Questionnaire for National Security Positions (or equivalent OPM investigative product)

• Two FD-258 Applicant Fingerprint Cards

• Original Signed Release Statements

9.6.1. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date. To maintain continuing authorization for an employee to access Privacy Act information on a DOD unclassified computer/network, the contractor shall ensure that the individual employee has a current requisite background investigation. The Contractor’s Security Representative shall be responsible for initiating reinvestigations as required and ensuring that background investigations remain current (not older than 10 years) throughout the contract performance period.

9.6.2. When access to IT systems is required for performance of the contractor employee’s duties, such employees shall in-process with the Navy Command’s Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date.

9.6.3. When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

9.6.4. The Contractor’s Security Representative shall ensure that each individual employee pending assignment shall accurately complete the required forms for submission to the Navy Command Security Manager. The Contractor’s Security Representative shall screen the investigative questionnaires for completeness and accuracy and for potential suitability/security issues prior to submitting the request to the Navy Command’s Security Manager. Forms and fingerprint cards may be obtained from the Navy Command’s Security Manager. These required items, shall be forwarded to the Navy Command's Security Manager for processing at least 30 days prior to the individual

Employee’s anticipated date for reporting for duty. The Navy Command’s Security Manager will review the submitted documentation for completeness and accuracy prior to submitting it to the Office of Personnel Management (OPM). Suitability/security issues identified by the Navy may render the contract employee ineligible for the assignment. An unfavorable determination made by the Navy is final (subject to SF 86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. If contractor employees already possess a current favorably adjudicated investigation, the Navy Command’s Security Manager will use the Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS). The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee’s performance under the contract.

9.6.5. The Navy Command’s Security Manager will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DON Central Adjudication Facility (CAF) for an eligibility determination.

9.7. DENIAL OF ACCESS

The potential consequences of any requirements under this clause including denial of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have physical access to a federally controlled facility and/or access to a federally-controlled information system/network and/or access to government information.

9.8. INTERIM ACCESS

The Navy Command's Security Manager may authorize issuance of a CAC card and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the SF-86 questionnaire and advance fingerprint results. When the results of the investigation are received and a favorable determination is not made, contractor employees working on the contract under interim access shall be removed immediately and will no longer be authorized to work on the contract.

9.8.1.

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

9.8.2.

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

9.8.3.

Fourteen (14) 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.

9.9. OCCUPATIONAL HEALTH REQUIREMENTS

9.9.1.

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.

The MTF will identify any contract employees who are not required to complete this documentation after contract award. Declinations shall only be permitted based on either the contract employee’s religious convictions or medical contraindications (as documented by a qualified health care provider).

9.9.2. 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.

9.9.4. HUMAN IMMUNODEFICIENCY VIRUS (HIV)

9.9.4.1. MANAGEMENT OF HIV POSITIVE CONTRACT EMPLOYEES

9.9.4.2.

HIV positive contract employees will be managed in accordance with the current Centers for Disease Control (CDC) guidelines and Section 503 of the Rehabilitation Act (29 U.S.C. Section 793) and its implementing regulations (41 CFR Part 60-741).

9.9.4.3. PREVENTION OF THE TRANSMISSION OF HIV

Contract employees shall comply with the CDC’s Universal Precautions for the prevention of the transmission of HIV. 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.

9.10. MANAGING THE CLINICAL RISK IN THE WORK ENVIRONMENT

The work environment inherently involves risks typically associated with the performance of job duties. The contract employee 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.

9.10.1.

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 the contract employee and the Contractor. The Contractor will be responsible for providing appropriate follow-up medical care and counseling, if applicable, and record-keeping.

9.10.2.

A contract employee 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 contract employee is otherwise entitled to Government medical services.

9.10.3 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 http://www.med.navy.mil/sites/nmlc/public_docs/Physical%20Exam%20and%20Immunization%20Form.pdf http://www.med.navy.mil/sites/nmlc/public_docs/Physical%20Exam%20and%20Immunization%20Form.pdf 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.

9.11. ORIENTATION

Contract employees shall attend and complete Orientation within 30 days following employee start date.

Workers shall attend orientation sessions as follows:

9.11.1.

Command Orientation is provided by the MTF consisting of annual training requirements for topics such as but not limited to fire, safety, infection control, family advocacy, Chemical, Biological, Radiological, Nuclear, and Explosive Events (CBRNE) Basic Awareness, and various Navy required on-line trainings.

9.11.2.

Contract employees shall attend Information Systems Orientation which includes the Composite Health Care System/Armed Forces Health Longitudinal Technology Application (CHCS/AHLTA), and other data systems.

This training shall occur during normal working hours.

9.11.3.

On a case-by-case basis, the Government may waive orientation sessions if the contract employee(s) is (are) currently or has (have) previously worked at the MTF.

9.11.4.

Contract employees shall complete all command required training, including but not limited to Diversity, HIPAA, Health stream, and Navy Knowledge Online courses.

9.11.5.

Contract employees providing service under this contract or resultant delivery orders shall undergo an orientation and shall complete mandatory Navy and DoD on-line training as indicated above. DoD on-line training may require the contract employee to enter his/her Social Security Number to document and track compliance with training requirements.

9.12. EMERGENCY PREPAREDNESS PLAN

Contractor 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 contractor 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.

9.13. TURNOVER OF CONTRACT EMPLOYEES

The Contractor shall recognize the potentially negative impact on the MTF created by staff turnover and the expense incurred by the Government for orientation and approval of new workers.

9.14. PRIOR WRITTEN PERMISSION REQUIRED FOR SUBCONTRACTS.

None of the services required by this contract shall be subcontracted to or performed by persons other than the contractor or the contractor's employees without the prior written consent of the Contracting Officer.

9.15 RESTRICTION ON THE USE OF GOVERNMENT-AFFILIATED PERSONNEL.

Except in very limited cases, the federal criminal statutes at 18 USC 203 and 18 USC 205 bar Government personnel, both active duty and civil service, from working as a contractor employee in a Government workplace, including a medical treatment facility, either as a second job ("moonlighting") or while on terminal leave. The contractor agrees that, before making an employment offer to an active duty member or a civil servant, it shall inform the individual of the potential applicability of these statutes and further agrees to encourage that individual to seek an advisory opinion from his/her local ethics counsel before accepting an employment offer.

SECTION 10 - STANDARDS

STANDARDS OF CONDUCT

10.1.1.

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.

10.1.2.

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.

10.2. CONTRACT EMPLOYEE STANDARDS

10.2.1.

The Contractor and all contract employees 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 a contract employees last day of service. Failure to do so promptly may result in delay of payment to the contractor.

10.2.2.

Eating by contract employees is prohibited in patient care areas/clinics and is restricted to designated areas. Smoking is prohibited in all clinic facilities.

10.1. CONFLICT OF INTEREST

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.

10.2. HIPAA COMPLIANCE

The contractor shall comply with the HIPAA (Health Insurance Portability and Accountability Act) privacy and security policies of the treatment facility. Providers shall obtain/maintain a National Provider Identifier (NPI) in accordance with DoD and Navy policy/instruction.

SECTION 11 ECMRA

11.1.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for Performance of services provided under this contract for the laser support services via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

https://doncmra.nmci.navy.mil.

11.2.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which is October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://doncmra.nmci.navy.mil.

SECTION 12 - DEFINITIONS

AMBULATORY DATA SYSTEM (ADS). A Government provided computer system linked through the MTF's local area network to the Composite Health Care System/ARMED FORCES HEALTH LONGITUDINAL TECHNOLOGY APPLICATION (CHCS/AHLTA) for collection of patient demographic and morbidity data. This system has also been referred to as ADS and KG-ADS. If ADS is not used by the MTF, the term “Government provided computer system” will be used in lieu of ADS.

ARMED FORCES HEALTH LONGITUDINAL TECHNOLOGY APPLICATION (AHLTA). A fully integrated information system that provides around the world access to a single data repository of all treatment episodes provided to TRICARE beneficiaries. The system provides a virtual, longitudinal electronic record ensuring health care providers always have access to current, legible information on population health, wellness and disease management activities.

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.

COMPOSITE HEALTH CARE SYSTEM (CHCS). A fully integrated information system supporting the functions of the Naval Hospital Pensacola. The system supports order entry and results reporting, administration, quality assessment and improvement, resource management, as well as mobilization and mass casualty. System upgrades periodically occur.

CONTRACTING OFFICER. The Contracting Officer is 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.

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

EMPLOYEE. For the purpose of this contract, employee means an individual either employed or subcontracted by the Contractor.

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

FEDERAL HOLIDAY(S). The following days are legally recognized holidays: New Year's Day (first day in January), Martin Luther King's Birthday (third Monday in January), President's Day (third Monday in February), Memorial Day (last Monday in May), Independence Day (fourth day of July), Labor Day (first Monday in September), Columbus Day (second Monday in October), Veteran's Day (eleventh day in November), Thanksgiving Day (fourth Thursday in November), and Christmas Day (twenty-fifth day in December).

FIXTURE. A moveable object, such as a machine, which by reason of being attached to real property (e.g., a building) is considered to be part of that real property.

FULL-TIME. A normally scheduled 1800 hours per work year of on-site effort based upon a 45 week, 40 hours per work week, calculation.

FURNITURE. A moveable object, such as a desk, which is used to equip a room or space to make that room or space usable for its intended purpose. The use of furniture may indirectly result in a work product.

HEALTHCARE PRACTITIONER. An unrestricted licensed physician (MD/DO), an unrestricted licensed Optometrist (OD), an unrestricted licensed or certified physician assistant, an unrestricted licensed and certified nurse practitioner or nurse midwife permitted by law and the MTF to provide patient care services.

HEALTHCARE PROVIDER. Health care practitioners and clinical support staff collectively.

IMMUNIZATION. The process of rendering a subject immune, or of becoming immune, by inoculation with a specific antigen to promote antibody formation in the body. Immunization is normally accomplished by injection through a medically appropriate route, i.e., subcutaneous, intramuscular, intravenous, intradermal, intra-arterial.

MAINTENANCE. The upkeep of buildings, fixture, 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). Navy hospitals or clinics, including all activities providing outpatient and/or inpatient health services.

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).

PRACTITIONER. See Healthcare

Practitioner. PROVIDER. See Healthcare

Provider.

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.

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