36C25622Q0129.docx

36C25622Q0129

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

36C25622Q0129 11-23-2021 Phyllis Shealey 318-990-4094 12-14-2021

3:00PM

CST

Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101 X 621999 $16.5 Million N/A X 36C564 Department of Veterans Affairs

WHSE/INSIDE DELIVERY V.A. MEDICAL CENTER

Veterans Health Care System of the Ozark 1100 N College Ave Fayetteville AR 72703 36C256 Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically 1-877-489-6135 Veterans Health Care System of the Ozarks has a requirement for Mobile Lithotripsy Laser service. The service must provide technician personnel and equipment, as described in the Performance Work Statement.

Price/Cost Schedule begins on Page 5.

Performance Work Schedule begins on Page 6.

Addendum to Instructions to Offerors begins on Page 67.

Addendum to Evaluation Criteria begins on Page All proposals must be received via email by date in time in Block 8 above to phyllis.shealey@va.gov. LATE SUBMISSIONS

WILL NOT BE ACCEPTED.

$0.00 N/A x x X David Miller 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: Contracting Officer 36C256 David Miller

Department of Veterans Affairs Overton Brooks VA Medical Center (90C) 510 East Stoner Avenue Shreveport LA 71101

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

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.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically

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

B.2 PRICE/COST SCHEDULE

Under the authority of Public Law 104-262, 38 U.S.C. 8153 and Veterans Affairs Acqusition Regulation (VAAR) Part 873, the Contractor agrees to provide Mobile Lithotripsy Laser service with technicians and equipment to Veterans Healthcare Systems of the Ozarks (VHSO), 1100 North College Ave., Fayetteville, AR 72703. A fixed-price, all-inclusive 5-year Indefinite Delivery Contract (IDC) will result from this solicitation. Task Orders will be issued by the Contracting Officer to fund services provided against the contract. Task Orders will be issued for no more than a 12-month period.

Performance period will be from 15 December 2021 (or from date of award) to 14 December 2026. The Contracror shall provide these services in accordance with all applicable federal, state and local regulations, laws and ordinances and in accordance with the performance work statement.

CLIN

DESCRIPTION

ESTIMATED MONTHLY QUANTITY

UNIT

UNIT PRICE

ESTIMATED YEARLY TOTAL PRICE

Ordering Period 1: 15 December 2021 (or from date of award) through 14 December 2022.

Procedures

ESTIMATED TOTAL AMOUNT (ORDERING PERIOD 1): $______________

Ordering Period 2: 15 December 2022 (or from date of award) through 14 December 2023.

Procedures

ESTIMATED TOTAL AMOUNT (ORDERING PERIOD 2): $______________

Ordering Period 3: 15 December 2023 (or from date of award) through 14 December 2024.

Procedures

ESTIMATED TOTAL AMOUNT (ORDERING PERIOD 3): $______________

Ordering Period 4: 15 December 2024 (or from date of award) through 14 December 2025.

Procedures

ESTIMATED TOTAL AMOUNT (ORDERING PERIOD 4): $______________

Ordering Period 5: 15 December 2025 (or from date of award) through 14 December 2026.

Procedures

ESTIMATED TOTAL AMOUNT (ORDERING PERIOD 5): $______________

ESTIMATE TOTAL (ALL ORDERING PERIODS) $______________

NOTE: Ordering periods for twelve (12) months are contingent upon date of award of contract.

Current pricing will also apply to any extension of Services under clause 52.217-8, Option to Extend Services, at the time the clause is exercised. The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be the pricing of the last order awarded prior to FAR 52.217-8 being executed under this clause. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the prices options has the same effect on the total price of all proposals relative to each other and will not affect the ranking of proposals based on price, unless, after reviewing the proposals, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8."

In accordance with FAR 16.504, the guaranteed minimum quantity of services the Government will acquire under this contract is fifteen (15) procedures. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum. The maximum quantity of services the Government will acquire under this contract is one hundred (100) procedures.

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. SERVICES REQUIRED: Contractor shall provide Mobile Lithotripsy/Laser equipment and related technical personnel and support to and at the Veterans Health Care System of the Ozarks (VHSO), Fayetteville, Arkansas in accordance with a regularly scheduled day(s) per month to be mutually agreed upon between the parties (subject to increase by mutual agreement between VHSO and Contractor). The VHSO anticipates an average of ten (10) veterans will be treated per month. The per-procedure pricing shall include single stone and multiple stone procedures per unilateral or bilateral episode. The equipment must be prepared to perform the first procedure of the day at 8:00 a.m. and continue to perform procedures until the VHSO’s schedule for the day is completed. Contractor equipment must fit through elevator doors of 4 feet wide and 7 feet tall.

1.1.1. Terms of Contract. This contract is a fixed-price Indefinite Delivery Contract (IDC), effective for five (5) years with Task Orders to be issued for up to 12-months each.

1.1.2. Under the authority of 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 VHSO, the Services and prices specified.

1.2. PLACE OF PERFORMANCE: On-site - VHSO, 1100 North College Ave, Fayetteville, AR 72703

1.3. AUTHORITY/POLICY/HANDBOOKS (with links):

1.1.1. VHA Handbook 1100.19 Credentialing and Privileging http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.1.2. Public Law 95-201 95th Congress An Act

www.gpo.gov/fdsys/pkg/STATUTE-91/pdf/STATUTE-91-Pg1433.pdf

1.1.3. 29 CFR Part 1910.1030 Toxic and Hazardous Substances https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=100 51

1.3.4. Public Law 104-191 Health Insurance Portability and Accountability Act of 1996 http://aspe.hhs.gov/admnsimp/pl104191.HTM

1.3.5. Bylaws of the Medical Staff, VHSO, Fayetteville, AR http://vaww.fayettevillear.va.gov/services/cos/bylaws.pdf

1.3.6. HHS OIG Exclusions List http://exclusions.oig.hhs.gov/Default.aspx

1.3.7. VHA Directive 2012-030 Credentialing of Health Care Professionals http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

1.3.8. Title 42 CFR 415.170 Centers for Medicare & Medicaid Services, HHS http://www.gpo.gov/fdsys/pkg/CFR-2013-title42-vol3/pdf/CFR-2013-title42-vol3-sec415-170.pdf

1.3.9. FAR 52.227-14(d)(1) Rights in Data

https://acquisition.gov/far/current/html/52_227.html 1.3.10. VA Directive 6300 Records and Information Management http://vaww1.va.gov/vapubs/viewPublication.asp?Pub_ID=429&FType=2

1.3.11. VA Handbook 6300.1 Records Management Procedures

http://vaww1.va.gov/vapubs/viewPublication.asp?Pub_ID=475&FType=2

1.3.12. VA Handbook 6500.1 Electronic Media Sanitization http://vaww1.va.gov/vapubs/viewPublication.asp?Pub_ID=416&FType=2;

1.3.13. FAR Part 12 Acquisition of Commercial Items

http://www.acquisition.gov/far/html/FARTOCP12.html

1.3.14. VA Handbook 1605.05 Business Associate Agreements

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3027

1.3.15. Title 5 U.S.C. 552a Records Maintained on Individuals http://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

1.3.16. Title 38 U.S.C 5701 Confidential Nature of Claims

http://www.gpo.gov/fdsys/pkg/USCODE-2011-title38/pdf/USCODE-2011-title38-partIV-chap57-subchapI-sec5701.pdf

1.3.17. Title 38 U.S.C 5705 Confidentiality of Medical Quality-Assurance Records http://www.gpo.gov/fdsys/granule/USCODE-2010-title38/USCODE-2010-title38-partIV-chap57-subchapI-sec5705/content-detail.html

1.3.18. Title 38 U.S.C 7362 Purpose of Corporations

http://www.gpo.gov/fdsys/pkg/USCODE-2011-title38/pdf/USCODE-2011-title38-partV-chap73-subchapIV-sec7363.pdf

1.3.19. 5 U.S.C. 552 Public information; agency rules, opinions, orders, records, and proceedings.

http://www.gpo.gov/fdsys/pkg/USCODE-2011-title5/pdf/USCODE-2011-title5-partI-chap5.pdf

1.3.20. 38 U.S.C. 7332 Confidentiality of Certain Medical Records http://www.gpo.gov/fdsys/granule/USCODE-2011-title38/USCODE-2011-title38-partV-chap73-subchapIII-sec7332/content-detail.html

1.3.21. VA Handbook 0710 PERSONNEL SUITABILITY AND SECURITY PROGRAM http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=86

1.3.22. VA Directive 0710 PERSONNEL SECURITY AND SUITABILITY PROGRAM http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1568

1.4. DEFINITIONS/ACRONYMS:

ACLS = Advanced Cardiac Life Support AIDS = Acquired Immunodeficiency Syndrome AIS = Automated Information Security BAA = Business Associate Agreement BBA = Balanced Budget Act BLS = Basic Life Support C&A = Certification & Accreditation CMP = Civil Monetary Penalty CEU = Certified Education Units CFR = Code of Federal Regulations

CPARS = Contractor Performance Assessment Reporting System CPT = Current Procedural Terminology CSCA = Contractor Security Control Assessment DEA = Drug Enforcement Administration (Certificate) EES = Employee Educational System FAR = Federal Acquisition Register FDA = Food and Drug Administration FIPS = Federal Information Processing Standards FOIA = Freedom of Information Act HHS = Health and Human Services

ISO = Information Security Officer JC = Joint Commission MOU-ISA = Memo of Understanding – Interconnection Security Agreements NARA = National Archives and Records Administration NIST = National Institute of Standards and Technology NPI = National Provider Identification OIG = Office of Inspector General OI&T = Office of Information Technology PII = Personally Identifiable Information PL = Public Law PPD = Purified Protein Derivative QASP = Quality Assurance Surveillance Plan SP = Special Publications SPI = Sensitive Personal Information USC = United States Code VA = Veterans Affairs VHA = Veterans Healthcare Administration VHSO = Veterans Health Care System of the Ozarks

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License. Contractor’s technical personnel shall be certified and trained in lithotripsy and laser services and operation of the equipment. Personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted license to practice the individual profession. The qualifications of such personnel shall be subject to review by the VHSO Chief of Staff and approval by the VHSO Facility Director. Contractor personnel providing contract services shall be licensed as a Radiologic Technologist. Contractor payment for services may be withheld if service is provided or authorized by unlicensed personnel, without regard to whether such services were medically necessary and appropriate. The VHSO, Fayetteville, Arkansas shall not approve of subcontracts with unlicensed individual or group providers.

2.1.2. Board Certification /Eligibility. N/A.

2.1.3. Credentialing and Privileging. N/A

2.1.4. Technical Proficiency. The Contractor’s technical personnel shall be certified in lithotripsy and laser services and operation of the equipment. The Technician will assist the attending Urologist and other physicians in the operation of the equipment. The technician may be required to operate the equipment and any related imaging equipment during procedures. The Contactor shall make available, upon request, copies of certificates, training, licensure or other information as requested by the Contracting Officer or the COR as evidence of the qualifications and/or experience of personnel providing services under this contract.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU): Requirements are in accordance with licensing requirements.

Training (ACLS/BLS/VA MANDATORY): Contractors shall complete computerized initial and annual training, provided by the COR, required in accordance with contract services provided. Training includes, but is not limited to, Cyber Security Awareness, HIPAA and Privacy Policies, and Infection Control. Training includes, but is not limited to, Cyber Security Awareness, HIPAA and Privacy Policies, and Infection Control. Learning University - Talent Management System (TMS) Log into: VA https://www.tms.va.gov/plateau/user/login.jsp. TMS is a self-registering computerized training system. Contractors should print off the completion certificate after completing the web-based course and send to COR.

2.1.6. Standard Personnel Testing. Contractor must provide proof of evidence of negative PPD skin test for tuberculosis screening to the COR for all Contractor employees providing contract services on VA property, prior to providing contract service, or the Contractor employees must accept the administration of a PPD skin test by the VHSO Employee Health Service. A PPD skin test is required annually thereafter.

2.1.7. National Provider Identification (NPI). Contractor provided Radiologic Technician does not require or hold NPI.

2.1.8. DEA (as required): N/A.

2.1.9. Conflict of Interest: Conflict of interest issues will be appropriately addressed as necessary.

Citizenship related Requirements. Physicians and personnel providing services under this contract having direct patient-care responsibility must speak and write English proficiently in accordance with PL 95-201. Any Subcontractor utilized by the Contractor for the provision of services required under this contract must meet the same qualifications specified herein for the Contractor. The Contractor must obtain approval from the Contracting Officer for any Subcontractor to be utilized for the provision of services required under this contract.

2.1.10. Annual Office of Inspector General (OIG) Statement. In accordance with HIPAA and the BBA of 1977, the U.S. Department of Health & Human Services OIG has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities that may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.11. Therefore, all Contractors shall review the OIG List of Excluded Individuals/Entities on the OIG website at www.hhs.gov/oig to ensure that the proposed Contract staff and/or firm(s) are not listed. Contractors should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health Care program, or causes such a claim to be submitted, may be subject to a CMP for each item or service furnished during a period that the person or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contract staff and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

2.1.12. By submitting their proposal, the Contractor certifies the OIG List of Excluded Individuals/Entities has been reviewed and the Contractor and/or firm was not listed as of the date the offer/bid was signed.

2.1.13. Medical Equipment. The Contractor will maintain a system of notification of equipment hazards, defects, and recalls and will maintain an effective, written recall plan. The Contractor will have written equipment preventive maintenance policies and procedures and will maintain a system for tracking all preventive maintenance by serial number. All preventive maintenance will be performed by trained personnel and in accordance with manufacturer’s guidelines. The Contractor is required to maintain medical equipment records that document the following:

2.1.13.1. Inventory.

2.1.13.2 Historical documentation of incoming inspection prior to use and ongoing inspection, testing and maintenance.

2.1.13.3. Monitoring and acting on hazard notices and recalls.

2.1.13.4. Participation in the Safe Medical Devise Act of 1990.

2.1.13.5. A Medical Equipment education program that addresses:

2.1.13.5.4. Information and skills necessary to perform maintenance. (maintainers).

2.1.13.5.5. Process for reporting failures (users and maintainers).

2.1.13.5.6. Annual chemical testing and monthly biological testing of water quality used in renal dialysis equipment (dialysis patients only).

2.1.13.5.7. Performance testing of sterilizers.

2.1.14. Contractor Recall and Safety Plan and Process Notification to Facilities. All Contractors shall take immediate action to notify the Contracting Officer whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe in order to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contract 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 to the Contracting Officer their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the Contracting Officer.

2.2. TECHNICAL DIRECTION:

2.2.1. Contract Administration. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the COR on all matters pertaining to contract administration. However, only the Contracting Officer is authorized to make commitments or issue changes, affecting 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 to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof.

2.2.2. Performance Measure Requirement. Veterans shall have procedures scheduled for completion within 30 calendar days of the date of the consult. At any time that this cannot be accomplished, the Contractor shall notify the Fayetteville VHSO Chief of Staff at 479-444-5050 immediately.

2.2.3. Upon request of the Government, the offeror must be able to show evidence of his/her reliability, ability and experience by furnishing (1) a list of personnel who will perform under the contract showing the length and type of experience of such personnel, and (2) the names and addresses of other concerns and/or Government agencies for which this type of service was rendered by the offeror.

2.2.4. The Contractor must be financially responsible and able to show evidence of their responsibility, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory service in the volume required for all items under this contract. By execution of this contract, the Contractor is certifying that all requirements of Federal, State or local laws, codes, and/or regulations regarding the operation of this type of service will be met.

2.2.5. Offers will be considered only from offerors who are regularly established in the business and who are, in the judgment of the Contracting Officer, financially responsible. Upon request of the Government, offerors shall be able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service in the volume called for under this contract.

2.2.6. The VHSO reserves the right to thoroughly inspect and investigate the establishment, facilities, equipment, business reputation, and other qualifications of an offeror, and to reject any offer irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance.

2.2.7. Offerors should thoroughly review the solicitation and be familiar with the requirements prior to submitting an offer in order to be fully aware of the supplies and/or services required. Failure to do so will not relieve the offeror from performing in accordance with the strict intent and meaning of the solicitation, without additional cost to the Government, should the offeror be awarded the contract.

2.2.8. The services to be performed by the Contractor will be reviewed by the VHSO Chief of Staff and the Chief, Surgical Service, who will provide monitoring of patient care activities. This will be accomplished by utilizing clinical review and provider specific profiling.

2.3. NON-PERSONAL SERVICES:

2.3.1. No Employee status. The parties agree that the Contractor, its employees, agents and Subcontractors shall not be considered VHSO employees for any purpose.

2.3.2. TORT. Contractor personnel are not covered by the Federal Tort Claims Act. When Contractor personnel are identified as a primary provider in a tort claim, the Contractor personnel is responsible for notifying the Contractor’s legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor personnel’s action or non-action is the responsibility of the Contractor and/or insurance carrier. The Contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following for these personnel:

2.3.2.1. Workers Compensation

2.3.2.2. Professional Liability Insurance

2.3.2.3. Health Examinations

2.3.2.4. Income Tax Withholding

2.3.2.5. Social Security Payments

2.3.3. Insurance. The Contractor physician personnel will attain and hold an in-force Professional Malpractice Insurance in an amount not less than one million dollars ($1,000,000.00) during the contractual period. Copies of insurance coverage shall be sent to the Contracting Officer. Policy renewal statements shall be sent to the Contracting Officer throughout the term of the contract, including option periods. The Contractor may be terminated for default due to a lack of insurance.

2.3.3. Contractor personnel providing services on VHSO property shall be electronically fingerprinted. A VA “ID Badge” will be issued to each Contractor employee and must be worn at all times when on VHSO property. Completion of initial Contractor training via the EES Librix On-line Learning Website (see item 2.1.6. above) and provision of a completion certificate is required prior to receiving a VA ID Badge.

2.4. KEY PERSONNEL AND EMERGENCY SUBSTITUTIONS:

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

The Contractors shall assign to this contract only those persons whose resumes, personnel data forms, or personnel qualification statements were submitted and approved as required. No substitution of personnel shall be made except as follows:

2.4.1. 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 fifteen (15) calendar days after the occurrence of any of these events and provide the information required by paragraph 2.4.3. below. After the initial ninety (90)-day period of the contract, the Contractor shall submit the information required by paragraph 2.4.3. to the Contracting Officer at least fifteen (15) days prior to making any permanent substitutions.

2.4.2. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes of the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within fifteen (15) calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.4.3. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays or more, the Contractor will provide a qualified replacement for the key person. Any period exceeding two (2) weeks will require the procedure as stated above.

2.4.4. The VA reserves the right to refuse approval under this contract or require dismissal from contract work of any Contractor or Subcontractor personnel who, by reason of unsatisfactory performance or for any other valid reason, is considered by the Contracting Officer to be objectionable.

3. Hours of Operation:

3.1. Business Hours: The services covered by this contract shall be furnished by the Contractor as defined herein. The Contractor will not be required to furnish such services during off-duty hours or Federal holidays as described below.

3.1.1. Work Schedule:

3.1.1.1. Work Hours: A mutually agreed upon scheduled day per month, selected from Monday through Friday, 8:00 a.m. to 4:30 p.m.

3.1.1.2. Off-Duty Hours: Friday through Monday, 4:30 p.m. to 8:00 a.m.

3.1.2. Federal Holidays: The ten (10) holidays observed by the Federal Government are:

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Christmas AND, any other day specifically declared by the President of the United States to be a Federal holiday.

3.1.3. Cancellation Policy: Requirements for cancellation (if any). Statement covering impact. Cancellation information will be provided to Contractor as quickly as possible once need is made known to COR. Every attempt to provide a timely alert to the Contractor regarding cancellation of appointments on a scheduled day of service will be made.

4. CONTRACTOR RESPONSIBILITIES:

4.1. SERVICES REQUIRED: The Contractor shall be responsible for providing the following:

4.1.1. Provide portable, state of the art, digital equipment that can be easily moved into the operating room at the VHSO. Equipment must meet or exceed the following criteria:

4.1.1.1. Treats all stones anywhere in the urinary tract.

4.1.1.5. Has the ability to do end urologic procedures before and after lithotripsy or laser or without moving the patient.

necessary to conduct lithotripsy and laser procedures with the equipment.

4.1.3. Maintenance of equipment to include service and preventative maintenance to insure that the equipment is in the highest level of functioning condition.

compliance with all federal, state, and local laws and regulations applicable to the equipment and delivery of lithotripsy and laser related services provided for under the terms of this contract.

4.1.6. Delivery of all reports, digital, film and file records of all procedures performed with the equipment to the COR. These medical records shall be the property of the VHSO, Fayetteville, Arkansas.

4.1.7. Contractor will perform services within the policies, procedures and regulations (such as the medical staff bylaws and professional standard board) governing the VHSO, Fayetteville, Arkansas, as provided upon award.

4.1.8. Re-treatment. If a veteran must undergo an additional treatment within ninety (90) days from their initial procedure due to continued problems with the stone(s), i.e., stone(s) not broken down small enough to pass or fragments of the stone remains, the Contractor will provide treatment at 50% of the contract cost.

4.1.9. Infection Control Compliance. Contractor and staff must be in training compliance with the Blood borne Pathogens Standards, 29 CFR Part 1910.1030 and provide written certification to that effect to the COR upon request.

4.1.10. Any incident of Contractor non-compliance as evidenced by the monitoring procedures shall be reported immediately by the COR to the Contracting Officer.

4.1.11. The COR for this contract will monitor specific performance of the contract requirements.

4.2. STANDARDS OF PRACTICE: Contractor shall be responsible for meeting or exceeding VA and JC (or equivalent) standards. Providers caring for patients and receiving payment for such care from the Department of Veterans Affairs shall meet the current Patient Safety Standards of the JC.

4.2.1. Contractor shall perform all services under this agreement in accordance with any and all regulatory and accreditation standards applicable to facility, including without limitations, those requirements imposed by the JC. Contractor shall provide consultation, if requested, in the development of protocols, utilization review, peer review and risk management as required by JC and other regulatory bodies.

4.2.2. The services and documentation to be performed by the Contractor will be performed in accordance with VA policies and procedures and the regulations of the VHSO Medical Staff Bylaws, Code of Ethics, Medical Center Memoranda, American Medical Association and JC. Contracted provider will comply with JC and Department of Veterans Affairs requirements pertaining to patient treatment and documentation; the VHSO Quality Assurance Requirements; locally accepted tenets of standard of care; the Network Performance VISN Plan; and Mission of the VA. All applicable policies/procedures/regulations will be provided to the Contractor upon award. Non-compliance of these requirements may result in the revocation of clinical privileges.

4.2.3. Contractor will be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

4.2.4. VHSO will monitor the Contractor employees’ work to ensure contract compliance.

4.2.5. Notwithstanding the contract requirements, upon request of the Contracting Officer, the Contractor will refuse permission to provide services under this contract of any Contractor employee who does not meet competency requirement for the work being performed.

4.2.6. While the contract does not require JC Accreditation or other regulatory body requirements, the Contractor must perform the required work in accordance with JC standards. A copy of these standards may be obtained from the Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

4.2.7. While the contract does not require JC Accreditation or other regulatory requirements regarding worker competency, the Contractor must perform the required work in accordance with JC standards. The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competency assessment checklist (an assessment of knowledge, skills, abilities, and behaviors required to perform a job correctly and skillfully; includes knowledge and skill required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this solicitation; and listing of relevant continuing education for the last two (2) years. The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the VHSO COR, or upon request for each Contractor employee working on the contract.

4.2.8. Contractor shall comply with all existing or future mandates regarding vaccination, testing, masking, and use of personal protective equipment.

4.3. RESIDENT SUPERVISION AND TEACHING: N/A.

4.4. MEDICAL RECORDS:

4.4.1. Authorities:

4.4.1.1. The Contractor is a VA Contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA Contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA Contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV and sickle cell anemia, to the extent necessary to perform its contractual responsibilities.

4.4.1.2. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S. C. 551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of Claimants Records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records), 38 U.S.C. 7332 (Confidentiality of Certain Medical Records), and federal laws, rules and regulations. Subject to applicable federal confidentiality of privacy laws, the Contractor, or their designated representatives and designated representatives of federal regulator agencies having jurisdiction over Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

4.4.2. HIPPA: The Contractor shall be in compliance with the HIPAA Act of 1966. PL104-191 also addresses pertinent issues related to security and confidentiality of individually identifiable health information and records that include protected health information. It is the responsibility of the Contractor to assure that patient records are protected against any anticipated threats or hazards to their security or integrity which could result in substantial harm, embarrassment, inconvenience, or unfairness to any individual for whom information is maintained.

4.4.3. Disclosure. Notwithstanding any other provisions of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

4.4.4. Professional standards for documenting care:

4.4.4.1. Record-Keeping Monitoring System. A record will be established by the COR for individual services for verification of actual procedures performed by the Contractor. The COR to monitor contract compliance is the Chief of Surgical Service or designee and is the VHSO official responsible for verification of actual procedures performed by the Contractor. Failure of Contractor to follow procedure may result in nonpayment or delay of payment.

4.4.4.2. As requested by the COR, the Contractor shall meet (conference calls are acceptable) with the COR to discuss contract performance, process improvement ideas, and the status of any contract issues.

4.4.4.3. The COR will furnish a statement in writing to the Contracting Officer at the close out of the contract to include summary of Contractor actions and a statement that all requirements of the contract were fulfilled as agreed.

4.4.4.4. A summary evaluation of Contractor performance based upon the compliance or noncompliance of contract requirements as evidenced under the monitoring procedures shall be forwarded by the monitoring official to the Contracting Officer prior to exercising any option.

4.4.5. Release of Information: Contractor shall forward any requests for Release of Information to the VHSO.

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

4.4.7. Personnel Clearances and Privacy Act Considerations:

4.4.7.1. All Contractor personnel shall be required to observe the requirements imposed on sensitive data by law, federal regulations VA statutes and policy, VHA policy, and the associated requirements to ensure appropriate screening of all personnel. Because of the inherent sensitivity of data at the facility concerned the level of security clearance required of the Contractor shall reflect the same level of security clearance carried by their Health Care Facility personnel for the function under contract. The Contractor shall ensure that his/her personnel and all involved Subcontractor personnel meet the above restrictions and that confidential and proprietary information shall be divulged only to those officers and officials of VA authorized to receive such information.

4.4.7.2. The VA system(s) of records to which the Contractor personnel will have access in order to maintain patient medical records and associated hardware is/are assigned by the Service Chief and will be subject to OI&T control and AIS. Contractor personnel who obtain access to hardware or media which may manipulate or store substance abuse, sickle cell anemia, HIV or AIDS treatment records or medical quality assurance records protected by 38 U.S.C. 7332 or 5705, as defined by the VA shall not have access to the records unless absolutely necessary to perform the contracted duties will see these records. Any individual who has access to this data will disclose it to no one, including other Contractor personnel not involved in the performance of the particular contractual duty for which access was obtained. Violation of these statutory provisions, as stated in VA regulations, by the Contractor or Contractor personnel, may involve imposition of criminal penalties.

4.4.8. Sales of Companies of name Changes: The Contractor shall notify the Contracting Officer in writing immediately upon entering an agreement (either oral or written) to sell or transfer all or part of its stock or other ownership interest to any other party. The Contractor shall also notify the Contracting Officer immediately in writing in the event a company name change will happen, with information as to the reasons and/or determinations causing the actions.

4.5. DIRECT PATIENT CARE: 85% of the time involved in direct patient care.

4.6. ADMINISTRATIVE: 15% of time not involved in direct patient care

4.6.1. Contractor shall be responsible for (List tasks, peer review, meetings, etc.):

4.6.1.1. Obtain information to assure appropriate invoicing.

4.6.1.2. Payment Remittance: Monthly billings will be sent to the following addresses:

4.7. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT:

4.7.1. Methods of Surveillance: Utilization of the QASP.

4.7.2. The VHSO and the Contractor shall establish and maintain a record keeping system to verify contract performance.

4.7.3. Performance 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. 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.

Quality Assurance Surveillance Plan (QASP)

Deduct

Method

5. GOVERNMENT RESPONSIBILITIES:

5.1. OVERSIGHT OF SERVICE/PERFORMANCE MONITORING: Services specified may be changed by written modification to this contract. The modification will be prepared by the Contracting Officer.

5.2. VA SUPPPORT PERSONNEL, SERVICES OR EQUIPMENT: The VHSO,…