36C24618R0784-006.docx

36C24618R0784

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

637-19-1-109-0003 36C24618R0784 July 18 David Smith, Contracting Specialist 757-728-7156 08- -2018

4:00 PM

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 621512 $14 Million X N/A X Department of Veterans Affairs Veterans Affairs Medical Center 1100 Tunnel Road Asheville, NC 28805 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 Contract to Provide Mobile Lithotripsy Services for VAMC Asheville, NC in accordance with the Performance Work Statement (PWS).

See Schedule located on Pages 6 thru 9 X X X Marchelle Peyton Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR:

b. GOVERNMENT: Marchelle Peyton Contracting Officer 36C246 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 will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer – System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in Arrears

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be mailed to the following address:

Department of Veterans Affairs Financial Services Center P.O. 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 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for Hub Zone Small Business Concerns. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

36C24618R0784

B.4 SCHEDULE OF SUPPLIES/SERVICES

Contractor shall only be paid for actual orders received. The Government contemplates award of a Firm-Fixed-Price (FFP) contract resulting from this solicitation.

The guaranteed minimum contract quantity, including the base year and any option years exercised, is 30 procedures and the maximum contract quantity, including the base year and any option years exercised, shall not exceed the total contract amount (150 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.

This contract type is Firm Fixed Price Indefinite Quantity / Indefinite Delivery contract. Contractor shall price Base and all Option Years the same.

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.

PERIOD OF PERFORMANCE: BASE YEAR (10/01/2018 -09/30/2019)

EA

EA

STAND BY CHARGES FOR NO-SHOW APPOINTMENTS

EA

TOTAL COST FOR BASE YEAR: $ _______________

PERIOD OF PERFORMANCE: OPTION YEAR I (10/01/2019 -09/30/2020)

EA

EA

STAND BY CHARGES FOR NO-SHOW APPOINTMENTS

EA

TOTAL COST FOR OPTION YEAR I: $ _______________

PERIOD OF PERFORMANCE: OPTION YEAR II (10/01/2020 -09/30/2021)

EA

EA

STAND BY CHARGES FOR NO-SHOW APPOINTMENTS

EA

TOTAL COST FOR OPTION YEAR II: $ _______________

PERIOD OF PERFORMANCE: OPTION YEAR III (10/01/2021 -09/30/2022)

EA

EA

STAND BY CHARGES FOR NO-SHOW APPOINTMENTS

EA

TOTAL COST FOR OPTION YEAR III: $ _______________

PERIOD OF PERFORMANCE: OPTION YEAR IV (10/01/2022 -09/30/2023)

EA

EA

STAND BY CHARGES FOR NO-SHOW APPOINTMENTS

EA

TOTAL COST FOR OPTION YEAR IV: $ _______________

TOTAL CONTRACT COST FOR BASE PLUS ALL OPTION YEARS: $_____________

B.5 PERFORMANCE WORK STATEMENT

SECTION 1 - DEFINITIONS:

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

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

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.

Contracting Officer's Technical 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.

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.

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

CGVAMC – means Charles George Veterans Affairs Medical Center.

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.”

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.

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

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.

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).

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.

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 Charles George VA Medical Center, Asheville, NC, 28805, 71360-4044, in accordance with the terms and conditions stated herein. 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 Charles George VA Medical Center, Urology Services. The Urology Service is located at:

Charles George VA Medical Center (CGVAMC) Surgical Services #112 1100 Tunnel Road Asheville, NC 28805

3.2. The performance period of this contract will be for a 12-month 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 Charles George VA Medical Center, Asheville, North Carolina, two scheduled Friday’s per month unless there is an occasion that requires a different day for an estimated 30 patients per year. The VA estimates that there will be 1 to 3 patients per visit. The per-procedure pricing shall include single stone and multiple stones procedures per unilateral or bilateral episode. 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.

4. PERSONNEL:

4.1. Schedule of Services: The Contractor shall perform on-site lithotripsy services two scheduled Friday’s per month unless there is an occasion that requires a different day. The Contractor shall be at the VAMC, Asheville, by 7:30 A.M., each scheduled day, ready to provide services and must remain on site until all patient care is completed for the day. The Contractor is expected to telephone the administrative staff one (1) hour prior to scheduled time of any potential delays. 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. No services shall be required on Government holidays.

4.1.1. QUALIFICATIONS:

· 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.

· 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.

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

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

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

· Describe firms’ contingency plan for schedule and unscheduled leave.

4.1.1.2. The Contractor shall be trained and certified on the operation of the ESWL device at the Surgical Service Line, Charles George 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.

4.1.1.3. 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.

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

4.1.1.5. Contractor required to immediately notifying the Contracting Officer and COR anytime a Contractor employee(s) and/or facility are involved in malpractice actions or loss of certification.

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

5. PERFORMANCE ASSESSMENT STANDARDS:

The Government will evaluate the contractor’s performance under this contract using the method of surveillance specified in the Quality Assurance Surveillance Plan (QASP) and 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.

Performance Measures

PWS

Ref Performance Requirement

Method Met AQL/DID NOT MEET AQL-CPAR Rating / Add Comments

100%

Direct Observation and random inspection

Meet AQL:

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

100%

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

100%

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

100%

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

98%

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

100%

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

100%

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency. Subsequent offenses = other than positive contractor evaluation

5.1. 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.

5.2. 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.

5.3. VAMC Monitoring/Recordkeeping

5.3.1. Contracting Officer's Technical Representative or his designate Quality Assurance (QA) representative will monitor the contractor’s services through one or a combination of the following mechanisms:

5.3.2. The Contracting Officer's Technical Representative (COR) will be responsible for verifying contract compliance. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

5.3.3. Documentation of services performed will be re-reviewed prior to certifying payment. The COR will verify all procedures billed were performed. VA will pay only for services performed at VA, and in strict accordance with the contract agreements. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

5.3.4. Monthly invoices will be provided to the COR for verification. The COR verifies services were performed against the electronic tracking system. Only after verification are invoices certified for payment.

5.3.5. An annual assessment evaluation will be submitted 60 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

5.3.6. It is the expectation that the performance of contracted services will meet basic principles of risk reduction, safety, staff competence, and performance improvement. The VA retains the right of oversight of quality and safety of services provided through the contractual agreement. Methods of oversight will include but not be limited to:

5.3.7. The Contractor shall ensure that all contracted services will be within the scope of their practice and/or license.

5.3.8. The Contractor shall provide documents such as policies and procedures to demonstrate compliance with Joint Commission standards related to competency assessment and initial and ongoing training for staff provision of care, treatment and/or services performed.

5.3.9. The Contractor shall provide documents such as policies and procedures to demonstrate prevention and management of safety risks; and, upon request, reports of incidents involving care, treatment and/or services of VA patients.

5.3.10. The VA will monitor and evaluate contracted services through selection of the best method as identified by the risk posed to patients by the contracted care, treatment, and/or services. Sources of information may include audit of documentation; review of incident reports provided and/or VA patient satisfaction information; review of quality data and information such as Joint Commission Clinical Core Indicator data and/or National Committee for Quality Assurance (NCQA) data such as Healthcare Effectiveness Data and Information Set (HEDIS) measures; and validation of Joint Commission Accreditation status.

SECTION 6. GOVERNMENT FURNISHED PROPERTY AND SERVICES:

6.1. Charles George VA Medical Center shall be responsible for providing the following:

6.2. 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 CGVAMC.

6.3. Suitable electrical service to operate the device.

6.4. A secure room for the device while located on the Charles George 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.

6.5. Scheduling of patients for the procedures and coordinating the scheduling of any required staff in-service related to use of the device. CGVAMC 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).

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

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

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

6.9. Record Keeping – the CGVAMC 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.

6.10. CGVAMC 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.

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

6.12. 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 47. The VA will not invalidate or make reimbursement for parking violations of the Department under any conditions

SECTION 7. CONTRACTOR FURNISHED ITEMS 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.

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

7.3. As stated in para 5.3, the Contractor shall provide the Lithotripter equipment for each procedure performed under this contract. In addition, the 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.

· 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.

· 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;

7.3.1. Contractor Recall and Safety Plan and Process Notification to Facilities. All Contractors shall take immediate action to notify the facility Contracting Officer 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 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.

7.4. 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.

7.5. Uniforms – Contractor employees shall provide their own Contractor nametags, which are to be worn always. The COR will provide one of the contractor employees a temporary Operating Room Key Card for entrance into the operating room suite. When working in the VA Operating Room, contract employees shall wear contractor provided scrubs.

SECTION 8. SPECIFIC TASKS:

8.1. The contractor shall provide Mobile Lithotripsy Services, Extracorporeal Shock Wave Lithotripsy (ESWL), equipment and related technical support laser technicians) at the Charles George VA Medical Center, Asheville, NC, two (2) Friday mornings per month. The specific Friday will depend on patient demand and by agreement of the parties.

8.2. The contractor shall provide technical and licensed personnel trained and certified in EWSL and operation of the device to the Charles George VA Medical Center, Asheville, NC. 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.

8.3. 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 Charles George VA Medical Center, Asheville, NC. The VA requires as a minimum, a Transportable STORZ Modulith brand or equivalent system. Equipment must meet or exceed the following criteria:

(1) Treat stones anywhere in the urinary tract.

(2) Have a large focal point to allow for maximal positioning.

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

(4) Modular unit to treat patients in the operating room.

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

(6) Can accommodate patients up to 400 pounds, and

(7) Have the capability to adapting to the existing electrical outlets in the operating rooms.

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

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

8.6. 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.

8.7. 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 Charles George VA Medical Center, Asheville, NC.

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

8.9. 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 PWS or to provide documentation to support the invoicing will be treated as incomplete services and will result in delayed processing of invoices.

8.10. Equipment Constraint. Upon arrival at the CGVAMC, 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 47 in Room EB-15 for equipment check in. Once the equipment has been checked, contractor personnel will follow the hallway to the elevator and proceed to the 2nd floor, Operating Room. Contractor personnel will then be sent to the perspective operating room.

SECTION 9. APPLICABLE PUBLICATIONS AND FORMS:

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

9.2. Joint Commission, VHA (Veterans Health Administration) and Other Standards.

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

9.3.1. 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.

9.4. 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.

SECTION 10. PAYMENTS UNDER NONPERSONAL SERVICE CONTRACTS:

10.1. 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.

10.2. Invoicing will be on a per-procedure basis in accordance with the pricing schedule. Invoicing for CPT code 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 CGVAMC, 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.

10.3. 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 CGVAMC, operating room records, and/or documentation reviews of medical records.

10.4. 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.

10.5. Monthly invoices will be sent to the Department of Veterans Affairs, Financial Services Center, and P.O. Box 149971, Austin, TX 78714-8971. A copy of the invoice and the supporting billing data will be submitted directly to the Contracting Officer’s Technical Representative on the same day the invoice is submitted to the Financial Services Center.

10.6. Payments made by CGVAMC 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 CGVAMC for services furnished to VA beneficiaries under the terms of this contract shall be billings in full.

10.7. 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.

36C24618R0784

B.6 SPECIAL CONTRACT REQUIREMENTS

1. Under the authority of Public Law 104262 and 38 USC 8153, the contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans Affairs Medical Center, the services and prices specified in the Section entitled Schedule of Supplies/Services of this contract.

a. The services specified in Section B. - Schedule of Supplies/Services may be changed by written modification to this contract. The modification shall be prepared by the Contracting Officer (CO) and, prior to becoming effective, shall be signed by both parties.

b. Contractor shall provide scheduled services throughout the contract period. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the Contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

c. If required providers must maintain current and active Drug Enforcement Agency (DEA) and Basic Life Support (BLS) certification, and provide copy of BLS certification to COR every two years.

d. The services to be performed by the contractor shall be performed in accordance with VA policies, procedures and regulations of the medical staff by laws of the VA facility.

e. The Government reserves the right to refuse acceptance of Contractor, if personal or professional conduct jeopardizes patient care. 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. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The Contracting Officer and Contracting Officer’s Representative (COR) shall deal with issues raised concerning contract personnel’s conduct. The final arbiter on questions of acceptability is the Contracting Officer.

f. 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. If 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.

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

2. WORK HOURS:

a. The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services on a Federal Holiday or during off duty hours as described below.

b. The following terms have the following meanings:

(1) Normal working hours will be 8:00 a.m. - 4:30 p.m. on scheduled Fridays each month unless there is an occasion that requires a different day of the month, excluding federal holidays. Contractor is responsible to arrive at 7:30 am, 30 minutes prior to the first scheduled appointment.

(2) Federal Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas

AND any other day specifically declared by the President of the United States to be a federal holiday. When one of the holidays falls on Sunday, the following Monday shall be observed as a Federal Holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

Off Duty hours: Hours other than those described in 5(b) (1).

3. TERMS OF THE CONTRACT:

The contract base period is effective from 10/01/2018 through 09/30/2019 plus four (4) 12-month option renewal periods. The contract is subject to availability of VAMC appropriations. The Contractor shall perform no services after September 30TH of each year until the contracting officer authorizes such services in writing.

a. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized by the local VAMC and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

b. The COR will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

4. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:

1. The Contractor shall assign to this contract the following key personnel:

a. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 5 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below.