ATTACHMENT D.1 - PERFORMANCE WORK STATEMENT FINAL.docx

36C24926Q0154 – Onsite Mobile Lithotripsy Service – James H. Quillen VA Medical Center D.1

PERFORMANCE WORK STATEMENT

ONSITE MOBILE LITHOTRIPSY EQUIPMENT & SERVICES

The James H. Quillen VA Medical Center (hereafter referred to as VAMC), has a need for a contractor to provide onsite Mobile Lithotripsy Services and Equipment, to include surgical subspecialty laser equipment and factory-trained Certified Medical Laser Safety Officer (CLSO or CLSO-M) assistant for the Operating Room (OR) at VAMC, located at the Corner of Veterans Way & Lamont Street, Mountain Home, TN 37684. The required equipment shall be as follows: a) Holmium: Lasers (both 20 watt & 100 watts) as back-up units in the event the VA-owned Holmium Laser is unavailable*; b) GreenLight XPS Laser System (180 watts); c) Aura XP Laser System; d) CO2 Flex Fiber Laser System; and e) CO2 Laser System Free Beam.

The CLSO/CLSO-M-certified assistant shall be required to use the VA-owned Holmium Laser (100 watt) and fibers manufactured specifically for use with this laser and purchased by the VA. In the event the VA-owned Holmium Laser is not available (e.g., out for preventative maintenance or repair), the CLSO/CLSO-M-certified assistant shall be required to use the contractor-owned Holmium Lasers with the manufacturer-specified fibers purchased by the VA. Under no circumstances are third-party manufactured fibers to be used at VAMC with either the VA-owned or contractor-owned Holmium Lasers.

SCOPE OF WORK:

The contractor shall provide the following equipment, or approved equal, on a case-by-case, as needed, basis:

(1) Holmium Laser System, 20 watts: Laser, medium beam, 2100 nm wavelength, beam-focusing mechanism, 650 nm wavelength diode laser visible red-aiming beam, American National Standards Institute (ANSI)-standard laser safety glasses and goggles, laser safety signs, delivery and set-up system, CLSO/CLSO-M-certified assistant to operate system.

(2) Holmium Laser System, 100 watts: Laser, medium beam, 2100 nm wavelength, beam-focusing mechanism, 650 nm wavelength diode laser visible red-aiming beam, ANSI-standards laser safety glasses and goggles, laser safety signs, delivery and set-up system, CLSO/CLSO-M-certified assistant to operate system.

(3) GreenLight XPS Laser System, 180 watts: Laser with XPS Fiber, ANSI-standard laser safety glasses, laser safety signs and goggles, delivery and set-up system, CLSO/CLSO-M-certified assistant to operate system.

(4) Aura XP Laser System, 15 watts: Laser, 532 nm pulsed wavelength, fiber delivery system, ANSI-standard laser safety glasses and goggles, laser safety signs, delivery and set-up system, CLSO/CLSO-M-certified assistant to operate system.

(5) CO2 (Carbon Dioxide) Flex Fiber Laser System, 40 watts: Laser with 10.6 micron infrared wavelength, up to 5mW red diode laser, 635 nm, fiber delivery system, ANSI-standard laser safety glasses and goggles, laser safety signs, delivery and set-up system, CLSO/CLSO-M-certified assistant to operate system.

(6) CO2 (Carbon Dioxide) Laser System: Laser, free beam, 10,650 nm wavelength, continuous wave, ANSI-standard laser safety glasses and goggles, laser safety signs, delivery and set-up system, CLSO/CLSO-M-certified assistant to operate system.

(7) CLSO/CLSO-M-certified assistant to operate VA-owned 100 watts Holmium Laser with VA-purchased fibers.

(8) Stand-by/Cancellation charges for items 1-7 above. If VA physician performing procedure determines that the use of the laser is not required, a stand-by/cancellation charge will be incurred when CLSO/CLSO-M- certified laser assistant and laser are in the OR.

PERSONNEL QUALIFICATIONS/EXPERIENCE CRITERIA:

Laser Assistant(s) performing the services covered by this contract shall be factory-trained and CLSO/CLSO-M-certified and shall present a record of credentials and competencies for approval, to be placed on file in the OR. The qualifications of the Laser Assistant(s) shall be subject to review by the VAMC Attending, and approval by the VAMC Chief of Surgery Service. The Contracting Officer will be notified prior to any changes in personnel. VA reserves the right to approve or disapprove the assignment of individual personnel furnished by the contractor to perform the functions specified in the task order. The personnel assigned by the contractor must complete VA credentialing process as required.

Personnel assigned by the contractor to perform the services must be U.S. Citizens and have current licensure/certification in good standing with the U.S.

Personnel assigned by the contractor to perform the services covered by this task order shall be proficient in written and spoken English (38 USC 7402).

Services shall be provided as soon as possible after notice of contract award and upon completion of all required Credentialing and Background Investigations (as applicable). VAMC will make every attempt to notify the Contractor as soon as possible when procedures are cancelled and/or rescheduled to release the contract employee. In the event of an emergency or unanticipated absence, the notification period will be less and the contractor will be expected to provide coverage within two days of notification. Contractor will make every effort to maintain consistency of assigned staff at the VA at all times for training, security, and continuity purposes.

The contracted individual will be required to show two proofs of identification on their first day of work. Acceptable proof of identification is as follows:

Acceptable PICTURE IDs:

· State-Issued Driver’s License

· State DMV-Issued ID Card

· US Passport

· Military ID/Dependents Card

· Foreign Passport

· Permanent Resident Card/Alien

· Registration Card w/Photo Acceptable NON-PICTURE IDs:

· Social Security Card

· Certified Birth Certificate

· State Voter Registration Card

· Native American Tribal Document

· Certificate of U.S. Citizenship

· Certificate of Birth Abroad Issued by the Department of State

Credentials Requested: The assistant will be required to complete credentialing during this assignment. An application package will be provided by the VA to be completed by the candidate. This includes curriculum vitae, current references, signed release of information from candidate and statement that candidate does not have any physical or mental health condition that would adversely affect his/her ability to carry out assigned duties, and additional credentialing forms. Candidates will also be required to make applications through the VETPRO Internet process. Candidates shall need to be enrolled in VETPRO by VA personnel. The website address is: https://fcp.vetpro.org. Our facility ID number is: 0621

PERSONNEL QUALIFICATION SUBMITTAL:

The contractor will submit the qualifications of the assistant(s) proposed to perform services under this contract. The Contracting Officer shall notify the contractor of acceptance or unacceptability within five (5) calendar days of receipt of submittal, based on the contents evidence that all qualification requirements are met. The contractor shall ensure that all qualifying criteria outlined in this section have been met, including current and valid licenses and certifications. The submittal shall consist of: (1) Name, social security number, date of birth, and copy of the Curriculum Vitae; (2) documentation of education and training; (3) copy of any license(s) which includes number and expiration date; (4) copy of certifications; and (5) Infection Control test results as specified in Section h.

PERSONNEL EXPECTATIONS:

The parties agree that the contractor’s laser assistant(s) shall not be considered VAMC employees for any purpose and shall be considered to be self-employed. The Contractor shall be responsible for providing the following for their own protection:

RESPONSIBILITY:

The Contractor shall perform services under the direction of the VAMC Chief of Staff, the Chief of Surgery Service, and VAMC Attending Surgeon.

In the event laser equipment and services have to be provided on an urgent or emergent basis during off-duty hours or national holidays, the contractor is required to respond telephonically within 15 minutes of receiving the call and must be in-house within two (2) hours of the original page or telephone call to provide laser equipment and services at VAMC.

The assistant must self-enroll in the Talent Management System (TMS) at www.tms.va.gov and notify the COR when self-enrollment is complete. Contracted employees annually complete the following mandatory TMS modules:

- TMS Module 10203, Privacy and HIPAA Focused Training

- TMS Module 10176, VA Privacy and Information Security Awareness and Rules of Behavior.

- TMS Module 7318, VHA CO Compliance and Business Integrity (CBI) Awareness Training

- TMS Module 3855743, Code Blue Procedures

- TMS Module 3978416, Occupational Safety, Health and Fire Protection Program

- TMS Module 3844813, Bloodborne Pathogens and Tuberculosis Exposure Training

- TMS Module 3836886, Emergency Operations

- TMS Module 3870605, VHA Minimizing Risk for Fluoroscopic X-Ray

- TMS Module 3890386, Fire Safety in the OR

QUALITY ASSURANCE:

The Contract laser assistant shall be subject to the same quality assurance standards meeting or exceeding current recognized national standards as established by The Joint Commission (TJC). The contractor shall perform services in accordance with established principles and ethics of the nursing profession established by TJC and Veterans Health Administration (VHA) regulations. The Contractor shall be technically proficient in the skills necessary to fulfill the Government’s requirements, to include the ability to speak, understand, read and write English fluently. The Contractor shall be responsible for compliance with all applicable VAMC written policies and procedures. The Contractor shall not introduce new procedures or services without prior recommendation to, and approval of, VAMC or authorized representative and the Contracting Officer’s Representative (COR).

INFECTION CONTROL REQUIREMENTS:

(1) Health Tests: Upon VAMC request, contractor personnel shall provide proof of the following tests within five (5) days prior to first duty shift. Tests shall be current within the past year:

(a) Tuberculosis Testing - All contractor personnel shall provide proof of a negative reaction to Purified Protein Derivative (PPD) testing. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

(b) Rubella Tests - All contractor personnel shall provide proof of immunization for varicella, measles, mumps, and rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization must be administered with follow-up documentation to the COR.

(2) OSHA Regulation Concerning Occupational Exposure to Bloodborne Pathogens: The contractor shall provide the Hepatitis B vaccination series at no cost to its personnel who elect to receive it; maintain and distribute an exposure determination and control plan to its personnel; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

(3) Communicable Disease Exposure: VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. The Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (AJIC 1998; 26:289-354) for disease control. The Contractor shall provide follow-up documentation of clearance to return to the workplace prior to their return.

RECORD KEEPING:

VAMC shall establish and maintain a record-keeping system that shall record the services performed by the Contractor. The Contractor shall report to the COR or designee upon arrival at VAMC.

CERTIFICATIONS:

Annually the Contractor will provide to the COR the following documents for all assistants performing services under this contract:

1. Current copy of their Laser Certification.

2. Current copy of their Laser Competency Form.

3. Current company background check.

4. Current drug test certification.

5. Current infection control requirement test results.

QUALITY IMPROVEMENT:

The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered, e.g., professional judgments, diagnosis for specific medical treatment, in accordance with Revolutionary FAR Overhaul Part 37.

PATIENT SAFETY

Patient Safety incidents must be reported immediately (within 24 hours) to the Patient Safety Officer.

STANDARDS FOR CONDUCT

The Government reserves the right to refuse acceptance of the Contractor if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of VAMC. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patients or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The Contracting Officer and COR shall deal with issues raised concerning contract personnel’s conduct. The final arbiter on questions of acceptability is the Contracting Officer.

The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is the final authority on validating complaints. In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

VAMC personnel shall brief Contractor on VAMC policies and procedures on the first scheduled duty day.

The Contractor rendering services is subject to professional or technical direction from the Attending Surgeon, OR staff and COR.

The VA shall provide the Contractor the name, title, and telephone number of the COR at the time of contract award.

The Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

INSPECTION:

The VAMC Biomedical Engineering staff will inspect the laser equipment upon each set-up in the OR, prior to the first procedure. The contractor staff is to have a current Preventative Maintenance (PM) inspection sheet with them when they arrive with the equipment. If they do not, then a copy must be faxed to VAMC Surgery Service prior to the first case (FAX number: 423-979-2696).

BADGES:

The Contractor is required to wear I.D. badge during the entire time they are on VAMC grounds. I.D. badge must have an identification picture and shall be issued by VAMC.

NO SMOKING POLICY:

Except in designated areas, smoking is strictly prohibited inside, at the entrances and on the patios and balconies of all buildings.

PERSONAL IDENTIFIABLE INFORMATION:

Contractor shall not remove personal identifiable information (e.g., full name, social security number, date of birth, etc.) from VAMC. Limited information for invoicing purposes only (first initial, last name) may be removed.

END OF PERFORMANCE WORK STATEMENT