S02 36C25924R0094_1 POSTED FOR SOL.docx

36C25924R0094

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.

UEI:

EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25924R0094 05-30-2024 Claudia Coria 3037125766 06-14-2024

4:00 PM

MDT

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 X 621512 N/A X

DEPARTMENT OF VETERANS AFFAIRS

George E.

Wahlen Department of Veterans Affairs Medical Center Salt Lake City UT 84148 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

INVOICES SUBMITTED ELECTRONICALLY

www.tungsten-network.com/us/support/ 1-877-489-6135 Department of Veterans Affairs Financial Email:

vafsccshd@v

1-877-353-9791 See CONTINUATION Page Lithotripsy Services for the George E.

Wahlen Department of Veterans Affairs Medical Center Questions pertaining to this solicitation are due by June 4 2024 by 4:00PM, MST. Questions must be submitted via email only to Claudia Coria at claudia.coria@va.gov

Telephone i nquiries are not accepted.

Proposals are due by June 14, by 4:00PM MST. Proposals must be submitted via email only to Claudia Coria at claudia.coria@va.gov.

Incumbent: Utah Lithotripsy, L.P, Base year plus four option periods contract value: $107,100.00 Late proposals will not be ac cepted.

See CONTINUATION Page X X X 1(one) 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 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

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.

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

B.2 PRICE COST SCHEDULE – LITHOTRIPSY SERVICES

SCHEDULE OF SERVICES

The Contractor shall furnish all key personnel to provide services necessary to perform onsite Lithotripsy Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, VA Salt Lake City Healthcare System (VASLCHS). The contractor’s technician(s) shall cover a range of Lithotripsy Services as would be provided in a civilian medical treatment facility and the standard of care shall be of quality, meeting or exceeding vendor specific training for the Lithotripsy procedures.

Place of Performance: Services shall be provided on-site at the VASLCHS 500 Foothill Blvd, Salt Lake City, Utah, 84148.

Pricing Instructions:

Offerors shall identify level of experience for the key personnel submitted.

The offeror is instructed to include the proposed price as directed in Instructions to Offerors addendum to 52.212-1 and Section D- Contract Documents, Exhibits, or attachments, if applicable.

The Contractor shall propose a minimum of one (1) key personnel to be credentialed and be available for scheduling to meet the requirements of the contract.

LINE ITEM

NUMBER

COST

Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment in accordance with the PWS.

Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment in accordance with the PWS.

Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment in accordance with the PWS.

Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment in accordance with the PWS.

Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment in accordance with the PWS.

B.3 PERFORMANCE WORK STATEMENT – LITHOTRIPSY SERVICES

1. GENERAL:

1.1. Services Provided: The Contractor shall provide certified Extracorporeal Shock Wave Lithotripsy (EWSL) Services in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the VASLCHS.

1.2. Place of Performance: Contractor shall provide on-site services at VASLCHS 50.0 Foothill Blvd. Salt Lake City, Utah, 84148.

1.3. Authority: Public Law 104-262 and 38 USC 8153.

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20 Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21 Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

1.4.11. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.12. Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5. Acronyms/Definitions: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ABU: American Board of Urology

1.5.2. ACLS: Advanced Cardiac Life Support

1.5.3. BLS: Basic Life Support

1.5.4. CDC: Centers for Disease Control and Prevention

1.5.5. CEU: Certified Education Unit

1.5.6. Clinical Privileging: Clinical privileging is the process by which a technician, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.5.7. CMS: Centers for Medicare and Medicaid Services

1.5.8. Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.9. Contracting Officer’s Representative (COR): A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.10. COS: Chief of Staff

1.5.11. CPARS: Contractor Performance Assessment Reporting System

1.5.12. ED: Emergency Department

1.5.13. EHR: Electronic Health Record - electronic health record system used by the VA

1.5.14. FSMB: Federation of State Medical Boards

1.5.15. FTE: Full Time Equivalent VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.16. HHS: Department of Health and Human Services

1.5.17. HIPAA: Health Insurance Portability and Accountability Act

1.5.18. HR: Human Resources

1.5.19. ISO: Information Security Officer

1.5.20. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.21. Medical Emergency: a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in: Permanently placing a patient's health in jeopardy, causing other serious medical consequences, causing impairments to body functions, or causing serious or permanent dysfunction of any body-organ or part.

1.5.22. NPI: National Provider Identifier. NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.5.23. POP: Period of Performance

1.5.24. PPD: Purified Protein Derivative

1.5.25. PWS: Performance Work Statement

1.5.26. QA/QI: Quality Assurance/Quality Improvement

1.5.27. QM/PI: Quality Management/Performance Improvement QASP: Quality Assurance Surveillance Plan

1.5.28. VETPro: VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.29. VHA: Veterans Health Administration

1.5.30. VISN: Veterans Integrated Services Network

1.5.31. VistA: Veterans Information Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility

2.2. The Contractor’s technical personnel shall be certified and trained in ESWL services and operations of the unit(s). The Technician will assist the attending Urologist in the operation of the device. The technician may be required to operate the device and any related imaging equipment during procedures.

2.2.1. License: The Contractor’s technicians(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to perform services in the state of Utah when services are performed onsite on VA property.

2.2.1.1. All licenses held by the key personnel working on this contract shall be full and unrestricted licenses. Contractor’s technician(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action, or denied upon application will not be considered for the purposes of this contract.

2.2.2. Certification: All contractor’s technician(s) shall be certified and trained in EWSL services and operation of the unit(s). All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.2.3. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The Contractor is responsible to ensure that proposed technician(s) possesses the requisite credentials enabling the granting of privileges.

2.2.3.1. If a Contractor’s technician(s) are not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.2.4. Technical Proficiency: Contractor’s technician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contractor’s technician(s) and contractor’s technician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.2.5. All Continuing Education requirements shall be met to maintain professional status. A staffing plan, to include back-up coverage, position description, and competency assessment tools shall be provided to the Contracting Officer Representative (COR) within fifteen (15) calendar days after award. The staffing plan shall be approved by the VAMC prior to commencement of patient care activities. All related documentation, such as completed competency checklists or education training records, shall be maintained by the Contractor and the VAMC.

2.2.6. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.): Contractor shall provide proof of the following for technicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.2.6.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s technician(s) upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

2.2.6.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor technicians {This is applicable to all health care workers}.

2.2.6.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor technicians {This is applicable to all health care workers}.

2.2.6.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor technicians {This is applicable to all health care workers}.

2.2.6.5. INFLUENZA: Contractors shall provide proof that all Contractor technicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor technician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.2.6.6. COVID-19: Contractors shall provide proof that all Contractor technicians have received COVID-19 vaccine unless it is contraindicated. If the Contractor technician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.2.6.7. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s technician(s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.2.6.8. The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.2.7. Conflict of Interest: The Contractor and all contractor’s technician(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.2.8. Citizenship related Requirements:

2.2.8.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

2.2.8.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract, or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.2.8.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.2.8.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.2.8.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

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

2.2.9.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s technician(s) are not listed. Contractor 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 Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person 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 Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

2.3. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.4. Non-Personal Healthcare Services: The parties agree that the Contractor and all contractor’s technician(s) shall not be considered VA employees for any purpose.

2.5. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.6. Prohibition Against Self-Referral: Contractor’s physicians are prohibited from referring VA patients to contractor’s or their own practice(s).

2.7. Inherent Government Functions: Contractor and Contractor’s technician(s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.8. No Employee status: The Contractor shall be responsible for protecting Contractor’s technician(s) furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.8.1. Workers’ compensation

2.8.2. Professional liability insurance

2.8.3. Health examinations

2.8.4. Income tax withholding, and

2.8.5. Social security payments.

2.9. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contractor’s technician(s). When a Contractor or contractor’s technician(s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contractor’s technician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.10. Key Personnel:

2.10.1. The VA Full Time Equivalency (FTE) defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.10.2. The minimum number of certified technicians required to be on site as needed is one (1) to be on site at the same time as defined in paragraph Hours of Operation in this section.

2.10.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations, and additional coverage as required. In the event a scheduled technician is unable to complete an assigned shift, the contractor shall provide replacement physician coverage within 2 hours and notify the Contracting Office Representative (COR) immediately of the schedule change.

2.10.4. Personnel Substitutions: During the first ninety (90) calendar 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 CO, in writing, within 30 calendar day (s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 30 calendar days prior to making any permanent substitutions.

2.10.4.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 30 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.

2.10.4.2. For temporary substitutions where the key person shall not be reporting to work for 30 consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.10.4.3. 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. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s technician(s), s/he may request, without cause, immediate replacement of said Contractor’s technician(s). The CO and COR shall deal with issues raised concerning Contractor’s technician(s) conduct. The final arbiter on questions of acceptability is the CO.

2.10.4.4. Contingency Plan: Because continuity of care is an essential part of the facility’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s technician(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: Clinic or OR Schedule: Monday through Friday 0800 to 1630.

3.1.1. 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 on a national holiday or outside the standard work hours of 8:00am to 4:30pm.

3.1.2. Patients must be seen by contractor’s technician(s) on-site at the facility in a timely manner in accordance with VA Rules and Regulations on clinic wait times and consult completion. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

3.1.3. Contractor’s Technician(s) shall be available and present in clinic during normal facility clinic hours, which will be established, and may be revised, as deemed appropriate for patient care by the Chief of Staff.

3.1.4. Off-hours Coverage: There are no off-hours coverage.

3.2. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared to be a national holiday.

3.3. Retreatment and Cancellation

3.3.1. Cancellation: Patient will be rescheduled to the next available OR time slot for Lithotripsy services.

3.3.2. If a veteran must undergo an additional treatment within ninety (90) days with his/her initial procedure due to continued problems with the stone(s) and at no fault of the contractor, i.e. stone(s) was not broken down small enough to pass or fragments of the stones remain, the Contractor shall provide the additional treatment at 22.73% of the contract price.

3.3.3. Cancellations. This may occur (1) when a stone passes between the time the patient was initially seen and scheduled and the actual procedure date or (2) when there is a medical emergency such as when anesthesia is administered or another medical emergency with the patient arises.

3.3.4. The Contractor shall not charge any amount for technical failures that occur during treatment or that prohibit treatment.

3.3.5. Contractor shall provide the same professional level of care to VAMC patients and/or beneficiaries as to any other patient under his/her care. Contractor shall provide all services specified in this contract for any person for whom such services are ordered. The Contractor further warrants that he/she shall not subcontract any portion of these services.

3.3.6. Organizational Relationship: Contract staff is responsible for responding to guidance given by the Chief, Surgical Service

3.4. The estimated workload is four (4) procedures per date of service with a range of approximately one to six (1-6) cases as driven by patient care needs. The per procedure pricing shall single stone and multiple stone procedures per unilateral episode.

4. CONTRACTOR RESPONSIBILITIES

4.1. Clinical Personnel Required: The Contractor shall provide contractor’s technician(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Contractor’s technician(s) shall be responsible for signing in and out when in attendance. Sign in/sign out sheets will be used by the COR to confirm hours/day provided against the contractor’s invoices.

4.2. Standards of Care: The contractor’s technician(s) care shall cover the range of Lithotripsy Services as would be provided in a civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

4.2.1. American Urological Association Guidelines:

https://www.auanet.org/education/aua-guidelines.cfm

4.2.2. The professional standards of the Joint Commission (TJC): http://www.jointcommission.org/standards_information/standards.aspx

4.2.3. The standards of the American Hospital Association (AHA): http://www.hpoe.org/resources?show=100&type=8

4.2.4. The requirements contained in this PWS

4.2.5. The Contractor shall be responsible for providing the following:

4.2.5.1. A portable, state of the art, digital unit that can be easily moved into the operating rooms.

4.2.5.2. Equipment must be in the operating room ready to treat patient at least 30 minutes prior to scheduled procedure.

4.2.5.3. Contractor shall wait at least 15 minutes after scheduled procedure time prior to proceeding to the next patient.

4.2.5.4. Equipment must meet or exceed the following criteria.

4.2.5.4.1. Treats all stones anywhere in the urinary tract.

4.2.5.4.2. Performs the fragmentation of renal stones using non-invasive techniques. The success rate shall be at least 80%.

4.2.5.4.3. Is modular and can treat patients in the operating room.

4.2.5.4.4. Has the ability to do endourologic procedures before and after ESWL without moving the patient.

4.2.5.4.5. Will accommodate patients up to 400 pounds.

4.2.5.4.6. The system must provide disintegration efficiency with results comparable to like systems using spark-gap technologies.

4.2.5.4.7. System must be capable of being employed with all anesthetic types including IV sedation, as well as no anesthesia.

4.2.5.4.8. The system must be capable of at least an average treatment rate of one patient per hour averaged over an eight-hour period. Documentation to support this capacity must be provided with the proposal for evaluation.

4.2.5.4.9. Is available as needed for services.

4.2.5.5. Contractor shall provide such additional materials and supplies, including consumables as are necessary to conduct ESWL procedures with the Unit(s).

4.2.5.6. Contractor shall provide maintenance of the device to include service and preventative maintenance to insure that the device unequivocally performs/operates at a level equal to the equipment manufacturer’s original specifications. Preventative maintenance documents for Contractor equipment shall be available to the VAMC Biomedical Engineering staff upon request. All equipment is required to be safety checked by Biomedical Engineering staff each time it arrives on site before any procedures begin.

4.2.5.7. Contractor shall be responsible for obtaining all necessary licenses, approvals, and permits and be in compliance with all federal, state, and local laws and regulations applicable to the device and delivery of ESWL related services provide for under the terms of this contract.

4.2.5.8. The contractor equipment must not be connected to a VA computer network. Personally Identifiable Information (PII) including but not limited to name, date of birth and social security number must not be entered into the equipment at any time for any purpose. Contractor shall deliver all reports, digital, film and file records of all procedures performed with the device to the OR staff at the conclusion of treatment on the scheduled visit for all of the day’s lithotripsy patients. These medical records shall be the property of the VAMC or any related facility within the Veteran’s Health Administration (VHA) where the patient receives care.

4.2.5.9. 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 Joint Commission (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

4.2.5.10. Contractor shall perform services within the policies, procedures and regulations (such as the medical staff by-laws and professional standards board) governing the VAMC or any related facility within the VHA where the patient receives care.

4.2.5.11. ID Badges/Parking/Smoking Policy

4.2.5.11.1. All contractor personnel are required to wear VA-issued identification (ID) badges during the time that they are on the VA grounds.

4.2.5.11.2. It is the responsibility of the Contractor personnel to park only in designated parking areas. Parking information is available from Surgery Service or the VA Police.

4.2.5.11.3. Smoking is not permitted within or around the VAMC facilities, except in designated areas.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contractor’s technician(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (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), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA Privacy Act system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.4.4.

4.3.3. Disclosure: Contractor’s technician(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Directive 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the facility.

4.3.5. Release of Information: The VA shall maintain control of releasing any copies of patient health information or health records and will follow policies and standards as defined, but not limited to Privacy Act requirements. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.4. Direct Patient Care: estimated 100 % of the time involved in direct patient care. Contractor shall be responsible for the running of the Lithotripsy equipment as the VA physician performs procedure on the patient.

4.4.1. Scope of Care: Contractor’s technician(s) as appropriate and within scope of practice/privileging shall be responsible for providing Lithotripsy Services, including, but not limited to:

4.4.1.1. Clinic and Surgical Care: Contractor’s technician(s) shall provide Lithotripsy equipment operation during surgeries in the operating room. Contractor’s technician(s) shall be present on time for any scheduled surgeries as documented by physical presence in the operating room at the scheduled start time.

4.4.2. Administrative: estimated 0% of time not involved in direct patient care.

4.4.2.1. Quality Improvement Meetings: NA

4.4.2.2. Staff Meetings: NA

4.4.2.3. QA/QI documentation: The contractor’s technician(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications, and outcome of procedures.

4.4.2.4. Patient Safety Compliance and Reporting: Contractor’s technician(s) shall follow all established patient safety and infection control standards of care. Contractor’s technician(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be documented in the medical record of those impacted and disclosed to the patient or surrogate. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit an entry in the Patient Safety Reporting System, following up with COR as required or requested

4.4.2.5. Patient Safety Compliance and Reporting: Contractor’s technician(s) shall follow all established patient safety and infection control standards of care. Contractor’s technician(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be documented in the medical record of those impacted and disclosed to the patient or surrogate. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit an entry in the VA Patient Safety Reporting System, following up with COR as required or requested.

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

4.5.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). 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.

4.5.1.1. Monitoring of the Contractor’s performance shall be demonstrated as referenced in the Quality Assurance Surveillance Plan (QASP) and verification of patient records that the specified services were performed. The Contractor shall be required to sign an attendance log upon reporting for scheduled procedures and upon completion of the procedures. The COR shall be the VA official responsible for verifying contract compliance. Any incidents of Contractor non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer

4.5.2. 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.

4.5.3. 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.

4.5.4. Performance Standards:

4.5.4.1. Measure: Qualifications of Key Personnel

Performance Requirement: All contractor’s technician(s) shall be certified and licensed.

Standard: All (100%) contract technicians are board certified/licensed.

Acceptable Quality Level: 100% No deviations accepted.

Surveillance Method: Random Inspection of qualification documents Frequency: Annual

4.5.4.2. Measure: Scope of Practice/Privileging

Performance Requirement: Contractor’s technician(s) perform within their individual scopes of practice/privileging.

Standard: All (100%) contractor’s technician(s) perform within their scope of practice/privileges 100% of the time.

Acceptable Quality Level: 100% contractor’s technician(s) perform within their scope of practice/privileges 100% of the time.

Surveillance Method: Random Sampling of…