36C246-19-R-0058-006.docx

36C24619R0058

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C246-19-R-0058 03-07-2019 Mario L Santiago, Contracting Officer 757-251-4254 03-18-2019

12:00 PM

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 621512 $15 Million X N/A X Department of Veterans Affairs Salem Veterans Affairs Medical Center 1970 Roanoke Blvd Salem VA 24153 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

046070827 Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971 Contract to provide On-Site Lithotripsy Services in accordance with the performance Work Statement (PWS).

Please see Schedule of Supplies located on page 5 thru 7 for additional details.

X X X Mario L Santiago Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Mario L Santiago Contracting Officer (90C) Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be mailed to the following address:

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Monthly [X]

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2. SCHEDULE OF SUPPLIES AND SERVICES

Contractor shall only be paid for actual orders received. The Government anticipates award of a Firm Fixed Price (FFP) Indefinite Quantity / Indefinite Delivery (IDIQ) requirements type contract. Contractor shall price Base and all Option Years the same.

The guaranteed minimum contract quantity, including the base year and any option years exercised, is 84 procedures and the maximum contract quantity, including the base year and any option years exercised, shall not exceed the total contract amount (1,100 procedures) for the base year plus the four (4) option years.

Estimated quantities are provided for informational purposes only. The government is not obligated nor is the contractor guaranteed to be issued orders totaling the estimated quantities.

The per day minimum charge applies when the contractor makes timely delivery of the equipment to the VA site on a scheduled day no cases are performed.

The VA will pay, per episode of care, at the time the patient is treated.

Tasks Orders for services shall be authorized by the Contracting Officer Representative (COR) or designated representative.

Contractor shall provide rental of Urology Equipment and Technician for the Operating Room at the Department of Veterans Affairs Medical Center (VAMC), 1970 Roanoke Boulevard, Salem, Virginia 24153 in accordance with all terms, conditions, provisions, and the schedule of this solicitation.

BASE YEAR: APRIL 1, 2019 TO MARCH 31, 2020

TOTAL FOR BASE YEAR: $_________________

OPTION YEAR I: APRIL 1, 2020 TO MARCH 31, 2021

TOTAL FOR OPTION YEAR I: $__________________

OPTION YEAR II: APRIL 1, 2021 TO MARCH 31, 2022

TOTAL FOR OPTION YEAR II: $_______________

OPTION YEAR III: APRIL 1, 2022 TO MARCH 31, 2023

OF ISSUE

TOTAL FOR OPTION YEAR III: $_______________

OPTION YEAR IV: APRIL 1, 2023 TO MARCH 31, 2024

HOLMIUM: YAG LASER SYSTEM

EA

STAND BY CHARGES FOR HOLMIUM: YAG LASER SYSTEM

EA

EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

EA

GREENLIGHT LASER

EA

TOTAL FOR OPTION YEAR IV: $_________________

TOTAL CONTRACT COST FOR BASE PLUS ALL OPTION YEARS $_______________

B.3 PERFORMANCE WORK STATEMENT

1. DEFINITIONS:

1.1. The following terms when used in this Contract shall be defined as follows:

a. Acceptable Quality Level (AQL). The AQL is the maximum percent defective that, for purposes of sampling inspections can be considered satisfactory.

b. Contracting Officer (CO) - A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. Contracting officers are responsible for ensuring performance of all necessary actions for effective contracting, ensuring compliance with the terms of the contract, and safeguarding the interests of the United States in its contractual relationships.

c. Contracting Officer's Representative COR -. An individual designated by the Contracting Officer to act as his/her representative to assist in administering a contract. The source and authority for a COR are contained in the written letter of designation. The Contracting Officer may delegate one or more VAMC employees who are responsible for monitoring the performance of the Contractor.

d. Customer Complaint. A means of documenting certain kinds of contract service problems. A government program that is explained to every organization that receives service under this contract, which is used to evaluate contractor’s performance.

e. Defective Service. A service output that does not meet the standard of performance associated with it in the Performance Requirements Summary (PRS).

f. SALEM VAMC – means Salem Veterans Affairs Medical Center.

g. Non-personal services contract - a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.”

h. Performance Requirements Summary (PRS). Identifies the key service outputs of the contract that will be evaluated by the government to assure contract performance standards are met by the Contractor.

i. Quality Control. Those actions taken by a contractor to control the performance of services so that they meet the requirements of the PWS.

j. Quality Improvement (QI) - the ongoing process of responding to data gathered through quality monitoring efforts, to improve the quality of health care delivered to individuals. This process involves follow-up studies of the measures taken to effect change in order to demonstrate that the desired change has occurred.

k. Quality Monitoring (QM) - the ongoing process of assuring that the delivery of health care is appropriate, timely, accessible, available, medically necessary and in keeping with established guidelines and standards and reflective of the current state of medical knowledge.

1.2. Technical Definitions Peculiar to this PWS. (In alphabetical order).

a. ESWL: Extracorporeal Shock Wave Lithotripsy or Lithotripsy: For this agreement, lithotripsy means the following: Extracorporeal shock wave lithotripsy for kidney stones treatment overview. Extracorporeal shock Wave lithotripsy uses sound waves to break kidney stones into small pieces that can more easily pass into the bladder. The patient lies on a water filled cushion. X-rays or ultrasound tests are used to precisely locate the stone. High-energy sound waves pass through the body without injuring it and shatter the stone into small pieces.

These small pieces move through the urinary tract and out of the body more easily than a large stone. The process takes about an hour. Sedatives or local anesthesia may be used. A hollow tube (stent) may be used when stones larger than 2.5 cm (1 in.) are present. The stent helps the small stone pieces to pass and prevents blockage of the urethra.

b. JC: Joint Commission. An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 18,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

2. GENERAL:

2.1. Under the authority of Public Law 104-262, 38 U.S.C. 8153 and Veterans Affairs Acquisition Regulation (VAAR) Part 873, the Contractor agrees to provide Extracorporeal Shock Wave Lithotripsy (ESWL) services to beneficiaries of the Department of Veterans Affairs Medical Center (VAMC), 1970 Roanoke Boulevard, Salem, Virginia 24153, in accordance with the terms and conditions stated herein. The required equipment shall be as follows: a) Holmium: YAG Laser, b) Extracorporeal Shock Wave Lithotripter and c) Greenlight Laser. VA physicians will perform the actual procedures. The Contractor shall provide these services in accordance with all applicable federal, state and local regulations, laws and ordinances and in accordance with this performance work statement.

3. BACKGROUND INFORMATION:

3.1. The intent of this document is to establish a non-personal performance-based service contract with the terms, conditions, provisions, and specifications governing on-site lithotripsy services to be provided by the contractor for the Salem VA Medical Center, Urology Services. The Urology Service is located at:

Salem VA Medical Center (Salem VAMC) B143 Room First Floor Surgical Suite 1970 Roanoke Blvd Salem, VA 24153

3.2. The performance period of this contract will be for a 12-month base period with four (4) option years for an anticipated five (5) year performance period. The option periods are subject to FAR Clause 52.217-9, Option to Extend the Term of the Contract.

3.3. The contractor shall provide Mobile Lithotripsy Services, Extracorporeal Shock Wave Lithotripsy (ESWL) equipment and related technical support at the Salem VA Medical Center, Salem, Virginia, two scheduled Friday’s per month unless there is an occasion that requires a different day for an estimated 30 patients per year. Salem VAMC estimates that there will be 1 to 3 patients per visit.

3.4. The per-procedure pricing shall include single stone and multiple stones procedures per unilateral or bilateral episode.

3.5. The equipment must be prepared to perform the first procedure of the day at a mutually agreed upon time and continue to perform procedures until the VAMC’s schedule for the day is complete.

3.6. The Contractor is expected to telephone the administrative staff one (1) hour prior to scheduled time of any potential delays.

3.7. These services require coordination with VA Physician(s); therefore, the COR will coordinate the specific Friday of each month with the Contractor. The Government will provide one to two days advanced notification.

3.8. No services shall be required on Government holidays.

4. SCOPE OF WORK: The Contractor shall provide the following equipment, or approved equal, on a case by case as needed basis:

(a) Holmium: YAG Laser, medium beam, 2100 nm wavelength, fiber delivery system, beam focusing mechanism, 650 nm wavelength diode laser visible red aiming beam, laser safety glasses, laser safety signs, delivery and set up system, certified technician to operate system.

(b) Stand-by charges for item (1) above.

(c) Mobile Extracorporeal Shock Wave Lithotripter, treatment table, Compact Mobile C-Arm Fluoroscopy Unit, with imaging, imaging processing printer, delivery and set up of system, certified technician to operate system.

(d) Greenlight Laser - Greenlight Laser, Fibers, delivery and set up of the system and a qualified technician to operative the system.

5. SPECIFIC TASKS:

5.1. The contractor shall provide Mobile Lithotripsy Services, Extracorporeal Shock Wave Lithotripsy (ESWL), equipment and related technical support laser technicians) at the Salem VA Medical Center in Salem, Virginia, two (2) Friday mornings per month, if needed. The specific Friday will depend on patient demand and by agreement of the parties. The contractor will provide both Holmium and greenlight laser services, equipment and related technical support laser technicians) at the Salem VA Medical Center in Salem, Virginia, Monday through Friday and as needed. The specific need will be based on demand for services. And by agreement of both parties.

5.2. The contractor shall provide technical and licensed personnel trained and certified in EWSL, Greenlight, and Holmium Laser services and operation of the device to the Salem VA Medical Center, Salem, VA. The Technician shall assist the attending Urologist and other physicians in the operation of the device. The technician is required to operate the device and any related imaging equipment during procedures.

5.3. The Contractor shall provide a mobile, portable state of the art, digital unit that can be easily moved from place to place into the operating room at the Salem VA Medical Center, Salem, VA. The VA requires as a minimum, a Transportable STORZ Modulith brand or equivalent system, Greenlight Laser system, and a Holmium (YAG) Laser system. Equipment must meet or exceed the following criteria:

1. Treat stones anywhere in the urinary tract.

1. Have a large focal point to allow for maximal positioning.

1. Have a greater than 80% success rate, based on FDA clinical study data.

1. Modular unit to treat patients in the operating room.

1. Can do endourologic procedures before and after extracorporeal shock wave lithotripsy (ESWL) for kidney stones without moving the patient.

1. Can accommodate patients up to 400 pounds, and

1. Have the capability to adapting to the existing electrical outlets in the operating rooms.

5.4. The Contractor shall provide such additional materials and supplies, including electrodes and other consumables as are necessary to conduct ESWL procedures with the device.

5.5. The Contractor shall provide maintenance on the device to include service and preventative maintenance to insure the device is functioning at an optimal level.

5.6. The Contractor shall provide in-service training of VA staff assisting in the procedure as related to ESWL and the device prior to the first case, to include annual review/refresher with supporting documentation for VA staff file.

5.7. The Contractor shall deliver all reports, film, and file records of all procedures performed with the device to the Operating Room (OR) personnel. These medical records shall be the property of the Salem VA Medical Center, Salem, VA.

5.8. The Contractor shall furnish proof of licensure, as well as evidence of annual educational training and certification records for technicians. Contractor must have current license, education, training and must be certified at all times.

5.9. Timeliness. Timeliness is an essential component of this contact and the Contractor must adhere to established timeframes for the provision of service. Failure to provide the documentation required by this Performance Work Statement (PWS) or to provide documentation to support the invoicing will be treated as incomplete services and will result in delayed processing of invoices.

5.10. Equipment Constraint. Upon arrival at the Salem VAMC, the Lithotripsy equipment must be checked by Bio-med personnel before use. The Contractor must go directly to the Bio-Med shop, located in the basement of Building in Room 20-8 for equipment check in. Once the equipment has been checked, contractor personnel will follow the hallway to the elevator and proceed to the First floor, Operating Room. Contractor personnel will then be sent to the perspective operating room.

5.11. The Contractor shall be trained and certified on the operation of the ESWL device at the Surgical Service Line, Salem VA Medical Center. The Technician will assist the attending Urologist and other physicians in the operation of the device. The Technician is required to operate the device and any related imaging equipment during the procedures.

5.12. Contractor shall, without additional expenses to the Government, be responsible for obtaining all necessary licenses, approvals, and permits and follow all federal, state and local laws and regulations applicable to the lithotripter and delivery of ESWL related services provided for under this contract. The Contractor will be responsible for providing this information to the COR upon request.

5.13. Contractor personnel shall be subject to the same quality assurance standards, meeting or exceeding current recognized national standards as all regular Salem VAMC employees. Contractor personnel shall perform the services in accordance with the ethical, professional, and technical standards of Salem VAMC.

5.14. Contractor personnel shall perform within their individual scopes of practice/privileges 100% of the time. Contractor shall be required to immediately notifying the Contracting Officer (CO) and the Contracting Officer Representative (COR) anytime a Contractor employee(s) is involved in malpractice actions or loss of certification.

5.15. Contractor must provide treatment to patient in a timely manner. Therefore, the Technician shall be onsite and available during all scheduled appointments.

5.15. Contractor personnel shall provide up-to-date information regarding FDA approved equipment, recalls, and patient safety issues.

5.16. Contractor shall provide a detailed operational plan to include staffing for the first 90 days of this contract.

5.17. Describe the firms’ contingency plan for schedule and unscheduled leave.

5.18. The Contractor must be Joint Commission Certified/Complaint or certified by an appropriate professional accreditation agency.

6. PERSONNEL QUALIFICATIONS:

1. The Contractor’s Technician performing the services covered by this contract shall trained and certified in Extracorporeal Shock Wave Lithotripsy (ESWL) procedures by the American Registry of Radiology Technology.

1. The Offeror shall submit qualifications and licenses to include ARRT American Registry Radiologic Technologist and CV’s of personnel to be used in the performance of this contract.

1. The Contractor’s Technician must be a US Citizen.

1. The Contractor Technician must be able to read, write, speak and understand English.

7. CONTRACTOR FURNISHED EQUIPMENT AND SERVICES:

7.1. General. Except for those items or services specifically stated to be government furnished in the Statement of Work, the Contractor shall furnish everything else required to perform this contract. As stated in para 5.3, the Contractor shall provide the Lithotripter equipment for each procedure performed under this contract.

7.2. Contractor shall maintain a notification system of equipment hazards, defects and recalls and shall maintain an effective, written recall plan on any equipment used on this contract. Equipment must be maintained and VAMC Salem must be notified of any recalls or safety issues with the equipment

7.3. Contractor shall have a written equipment preventive maintenance program for any equipment used in this contract and shall maintain a system for tracking all preventive maintenance by serial number. All preventive maintenance shall be performed by trained personnel and in accordance with manufacturer’s guidelines.

7.4. Contractor shall be required to maintain medical equipment records that document the following:

a. Inventory

b. Historical documentation or incoming inspection prior to use and ongoing inspection, testing and maintenance

c. Monitoring and acting on hazard notices and recalls participation in the Safe Medical Device Act of 1990 a Medical equipment education program that addresses:

i. Capabilities, limitations and special applications of equipment;

7.5. Contractor Recall and Safety Plan and Process Notification to Facilities. All Contractors shall take immediate action to notify the facility Contracting Officer Representative (COR) whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe to remove such products, equipment of items from use. This notification also applies to safety alerts. The Contractor’s recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment or items can be made in as expedient and efficient manner as possible.

The Contractor shall provide the facility Contracting Officer Representative (COR) their plan for this safety notification process and maintain a record system to document any safety incident issues by their date, time and description of the recall or safety alert issue provided to the facility Contracting Officer Representative (COR).

7.6. The Contractor agrees to provide liability and malpractice insurance in the provision of all professional services rendered. In the event of litigation/investigation of a claim of liability or malpractice, the Contractor shall cooperate fully with the Government authorities and designated officials in the investigation of the claim or preparation for litigation.

7.7. Uniforms – Contractor employees shall provide their own Contractor nametags, which are to be worn always. The Operating Room Nurse Manager or other surgical staff will provide scrub attire that must be worn while working in the VA Operating Room.

8. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI)

8.1 The Government will evaluate the contractor’s performance under this contract using either the method of surveillance specified in the Quality Assurance Surveillance Plan (QASP) document attached to Section D on the Request For Proposal (RFP) and or the Performance Requirements Summary (PRS) specified below. All surveillance observations will be recorded by the Government. When an observation indicates defective performance, the COR will obtain the contractor’s representative’s initials on the record of the observation.

8.2 Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of each lithotripsy procedure. Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

8.3 Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is 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.

8.4 The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. 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 patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

8.5 Performance Standards:

5.2 Measure: Specific Tasks

Performance Requirement: The Technician shall assist the attending Urologist and other physicians in the operation of the device.

Standard: The technician is required to operate the device and any related imaging equipment during procedures.

Acceptable Quality Level: 100% meet Standards

Surveillance Method: Direct observation and random inspection.

5.7 Measure: Specific Tasks

Performance Requirement: The Contractor shall deliver all reports, film, and file records of all procedures performed with the device to the Operating Room (OR) personnel.

Standard: These medical records shall be the property of the Salem VA Medical Center, Salem, VA.

Acceptable Quality Level: 100%

Surveillance Method: Random Inspection of qualification documents

5.8 Measure: Specific Tasks

Performance Requirement: The Contractor shall furnish proof of licensure, as well as evidence of annual educational training and certification records for technicians.

Standard: Contractor must have current license, education, training and must be certified at all times.

Acceptable Quality Level: 100%

Surveillance Method: Random inspection of qualification documents

5.11 Measure: Specific Tasks

Performance Requirement: Contractor shall, without additional expenses to the Government, be responsible for obtaining all necessary licenses, approvals, and permits and follow all federal, state and local laws and regulations applicable to the lithotripter and delivery of ESWL related services provided for under this contract.

Standard: The Contractor will be responsible for providing this information to the COR upon request.

Acceptable Quality Level: 100%

Surveillance Method: Direct observation and random inspection.

5.12 Measure: Specific Tasks

Performance Requirement: Contractor shall, without additional expenses to the Government, be responsible for obtaining all necessary licenses, approvals, and permits and follow all federal, state and local laws and regulations applicable to the lithotripter and delivery of ESWL related services provided for under this contract.

Standard: The Contractor will be responsible for providing this information to the COR upon request.

Acceptable Quality Level: 100%

Surveillance Method: Random inspection of licensensing and permit documents.

5.13 Measure: Specific Tasks

Performance Requirement: Contractor personnel shall be subject to the same quality assurance standards, meeting or exceeding current recognized national standards as all regular Salem VAMC employees.

Standard: Contractor personnel shall perform the services in accordance with the ethical, professional and technical standards of Salem VAMC.

Acceptable Quality Level: 100%

Surveillance Method: Direct Observation and random inspection for all (100%) staff providing services under the contract.

5.14 Measure: Specific Tasks

Performance Requirement: Contractor personnel shall perform within their individual scopes of practice/privileges 100% of the time.

Standard: Contractor shall be required to immediately notifying the Contracting Officer (CO) and the Contracting Officer Representative (COR) anytime a Contractor employee(s) is involved in malpractice actions or loss of certification.

Acceptable Quality Level: Immediately.

Surveillance Method: Direct Reporting.

5.15 Measure: Specific Tasks

Performance Requirement: Contractor must provide treatment to patient in a timely manner.

Standard: Technician shall be onsite and available during all scheduled appointments.

Acceptable Quality Level: 100%.

Surveillance Method: Direct Observation and random Inspection

6.0 Measure: Personnel Qualifications /Staffing

Performance Requirement: All contract Technicians shall have all required current training, licenses and certifications.

Standard: All shall be compliant with all mandatory certifications

Acceptable Quality Level: 100%.

Surveillance Method: Random inspection of qualification documents.

7.2 Measure: Contractor Furnished Equipment and Services.

Performance Requirement: Contractor shall maintain a notification system of equipment hazards, defects and recalls and shall maintain an effective, written recall plan on any equipment used on this contract.

Standard: Equipment must be maintained and VAMC Salem must be notified of any recalls or safety issues with the equipment.

Acceptable Quality Level: 100%.

Surveillance Method: Periodic Inspections of equipment and contractor shall provide a safety plan

10.2 Measure: Applicable laws & publications

Performance Requirement: Contractor personnel(s) shall complete all required training on time per VAMC policy. Contractor personnel(s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA and complies withal standards Zero breaches of privacy or confidentiality.

Standard: All contractor personnel (s) shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA.

Acceptable Quality Level: 100%.

Surveillance Method: Periodic sampling. Contractor personnel(s) shall provide evidence of annual training as required by Salem VAMC.

8.3. Performance Evaluation Meetings. The Contractor may be required to meet periodically with the COR and Contracting Officer at the beginning of contract performance. Meetings will be scheduled as needed. The Contractor may request meetings whenever a Contract Discrepancy Report is issued. The written minutes of these meetings shall be signed by the Contractor, Contracting Officer and COR. If the Contractor does not concur with the minutes he shall state any areas of non-concurrence within 5 days of receipt of the signed minutes.

8.4. Cancellations. In the event of each cancelled Lithotripsy procedure by the Contractor for medical or non-medical reasons, the Contractor shall not be paid for the procedure and the cancellation will be considered in the Contractor’s past performance rating.

9. GOVERNMENT FURNISHED PROPERTY AND SERVICES: Salem VA Medical Center shall be responsible for providing the following:

9.1. Qualified physician to perform the procedures and provide appropriate personnel to administer any required anesthesia. Any pharmaceuticals required for the procedure will be provided by the Salem VAMC.

9.2. Suitable electrical service to operate the device.

9.3. A secure room for the device while located on the Salem VA Medical Center premises. VA shall provide a procedural room, telephone, electrical and water hookups. VA shall provide sterile supplies and pharmaceuticals required for performance of procedures.

9.4. Scheduling of patients for the procedures and coordinating the scheduling of any required staff in-service related to use of the device. Salem VAMC is responsible for the delivery/retrieval of patients to/from the procedural room in a timely manner (one patient each hour – or as determined in the coordination process).

9.5. Pre-procedure preparation of patients for ESWL, to include obtaining written patient consent forms and post-procedure services.

9.6. Any reasonable necessary assistance to the contractor in achieving compliance with federal, state, and local laws and regulations.

9.7. Collection and disposal of infectious waste and sharps related to the ESWL procedures.

9.8. Record Keeping – the Salem VAMC shall establish and maintain a record keeping system that will document the services provided. The Contractor shall report to the COR or designee upon arrival at the Medical Center.

9.9. Salem VAMC shall provide orientation for assigned contract agency staff according to expected duties and VAMC policy, procedures, and processes necessary to coordinate functions between the Contractor and VAMC. Up-dates and refreshers shall be provided upon request and when policy, procedure or processes change for the Contractor or VA. The COR shall determine appropriate VA staff to provide essential training and coordinate same.

9.10. VA will provide shoe covers and hair cover. Special clothing and equipment that are provided by Salem VAMC will be left at the workstation upon completion of duty shift.

9.11. The Government will provide parking for the contractor’s employees in the performance of this contract. Parking is permitted on the VA Grounds. The location for the contractor’s employees to park their vehicle is Building 143. The VA will not invalidate or make reimbursement for parking violations of the Department under any conditions.

10. APPLICABLE LAWS AND PUBLICATIONS:

10.1. Services shall be performed in accordance with all Salem VAMC established principals, ethics, standards, rules and regulations as set forth in VHA Directives, Salem VAMC Medical Staff Bylaws, and Salem VA Medical Center Memorandums. Information may be obtained from the Compliance Officer at the Salem VAMC.

10.2. Joint Commission, VHA (Veterans Health Administration) and Other Standards. Contractor personnel(s) shall complete all required training on time per VAMC policy. Contractor personnel(s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA and complies withal standards Zero breaches of privacy or confidentiality. All contractor personnel (s) shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA

10.3. Health and Human Services, Office of the Inspector General (OIG).

10.4. To ensure that the individual providing services under the contract has not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding Federal Health Care Programs, the government will check the Health and Human Services, Office of the Inspector General List of Excluded Individuals/Entities on the OIG Website, www.hhs.gov/oig for each person providing services under the contract. During performance of this contract, the Contractor is prohibited performing services on this contract if they are listed on the List of Excluded Individuals/Entities.

10.5. HIPAA Compliance. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA.

11. INVOCING AND PAYMENTS UNDER NONPERSONAL SERVICE CONTRACTS:

11.1. The Government shall pay the Contractor once monthly, upon submission of proper invoices or vouchers, the prices stipulated in this contract for services rendered and accepted. All services performed during the month should be combined in one bill, reference the correct funding document number and will be submitted in arrears. The Contractor is responsible for collecting all billing data that supports the invoice.

11.2. Invoicing will be on a per-procedure basis in accordance with the pricing schedule. Invoicing for procedures must include the contract and funding order number, the patient’s last name and last four digits of the SSN. The Contractor shall not charge Salem VAMC, for a lithotripsy procedure due to the patient no shows for the procedure or cancelling the procedure for any reason. The Government will make every effort to minimize the impact of no shows on the contract services.

11.3. To receive payment, Contractor personnel shall document their performance of the required duties by a mutually agreed upon system which may include: Sign-in sheet, phone message to appropriate Salem VAMC, operating room records, and/or documentation reviews of medical records.

11.4. The Contractor shall submit invoices for services rendered no later than (30) calendar days following the close of the month in which the procedure was reported. Subsequent changes or corrections must be submitted by separate invoice.

11.5. Payments made by Salem VAMC under this contract shall constitute the total cost of services provided by the Contractor. The Contractor hereby agrees that in no event shall the Contractor bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against the beneficiary (patient), the beneficiary’s family, private insurer, Medicare or any other entity acting on the beneficiary’s behalf, for services provided pursuant to this contract. Billings rendered by the Contractor to Salem VAMC for services furnished to VA beneficiaries under the terms of this contract shall be billings in full.

11.6. Contractor shall be compensated only for actual services rendered per procedure – inclusive with all charges incorporated into the one fee. No additional charge will be considered.

The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

12. BILLING:

12.1. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

12.2. Vendor Electronic Invoice Submission Methods: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements.

For additional information, please contact:

Tungsten Support:

Phone: 1-877-489-6135

Website: http://www.tungsten-network.com/uk/en/

Department of Veterans Affairs Financial Service Center:

Phone: 1-877-353-9791

Email: vafscched@va.gov

12.3. Payment Adjustments:

12.3.1 Invoices will be prorated for procedures performed. The contractor shall be paid only for actual work performed onsite. Contract providers shall be responsible for reporting time worked accurately. The Contract shall be paid for actual hours performed.

12.3.2 The contract shall be adjusted at the end of the period of performance (Base or Option Year) in accordance with actual performance.

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12.4. Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

12.4.1 To the extent that the Veteran desires services which are not a VA benefit or covered under the terms of this contract, the Contractor must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment.

12.4.2 The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract.

13. Contract Administration Data:

13.1 After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: Contracting Officer (CO) or Contracting Specialist (CS), Contracting Officer Representative (COR) contact information, Clinical point of contact, and any other relevant personnel involved).

13.2 The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

13.3 The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

13.4 In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

ALL CONTRACT ADMINISTRATION FUNCTIONS WILL BE RETAINED BY THE

DEPARTMENT OF VETERANS AFFAIRS.

13.5 After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

Mario L Santiago VAMC Hampton/VISN6 CAS Building 27, Avril Drive Hampton, VA 23667 Telephone #: 757-251-4254 Fax #: 757-728-3132 E-mail: mario.santiago@va.gov

CONTRACTING OFFICER'S TECHNICAL REPRESENTATIVE (COR):

13.6 The Contracting Officer's Technical Representative (COR) for this contract shall be addressed to:

Lunda Argabright COR’S Administrative Officer (AO) Salem VAMC 1970 Roanoke Blvd Salem, VA 24153 Telephone #: 540-982-2463, Ext – E-Mail: lunda.argabright@va.gov

13.7 The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

13.8 The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

13.9 The COR will maintain a record-keeping system for…