INPATIENT DIALYSIS SERVICES

VHA MEDICAL SHARING/AFFILIATE NATIONAL PROGRAM

OFFICE (MSO)

MASTER PACKAGE (PSC: Q509)

INCLUDES:

(1) SCHEDULE OF SERVICES

(2) PERFORMANCE WORK STATEMENT (PWS)

DRAFT

SCHEDULE OF SERVICES

The Contractor shall furnish all key personnel and dialysis specific equipment to provide services necessary to perform onsite inpatient dialysis services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, James Mountain Inhofe Veterans Affairs Medical Center, 440 S Houston Ave, Tulsa, OK 74127.

Services shall support the provision of Intermittent Hemodialysis (IHD) and Prolonged Intermittent Renal Replacement Therapy (PIRRT) only. Continuous Renal Replacement Therapy (CRRT) and Peritoneal Dialysis (PD) are not within scope of this contract.

All dialysis sessions shall be performed under the medical direction of VA-employed nephrologists and advanced practice providers. Contractor personnel shall execute dialysis treatments per physician orders and established facility protocols.

Place of Performance: Services shall be provided on site at James Mountain Inhofe Veterans Affairs Medical Center, 440 S Houston Ave, Tulsa, OK 74127

Personnel Categories:

Category Description Dialysis Registered Nurse

(RN) [MANDATORY]

Licensed RN with dialysis competency. CDN/CNN certification required or eligible. Responsible for patient assessment, dialysis initiation/monitoring/termination, medication administration coordination, and PCT supervision.

Biomedical Technician

[MANDATORY]

CBET certified or equivalent. Responsible for dialysis machine maintenance, water treatment system maintenance, RO unit maintenance, equipment troubleshooting, and quarterly QA participation.

Patient Care Technician

(PCT) [OPTIONAL]

State-certified where applicable. BONENT/NNCC certification preferred. Must work under RN supervision per Oklahoma state regulations. Assists with dialysis setup, monitoring, patient care tasks.

Supply Demarcation:

Contractor Provides: Personnel (RN, Biomed, PCT as applicable), all dialysis equipment (machines, water treatment systems), and consumables (membranes, tubing, needles, access supplies)

VA Provides: Intravenous fluids (0.9% NS, LR, D5W), medications administered during dialysis sessions (from VA Pharmacy), ESAs, and activated vitamin D analogs

Note: Antibiotics, ESAs, and activated vitamin D analogs will be administered by VA floor nurses working in coordination with contracted dialysis RNs.

Storage room: 9 feet by 8 feet in dimension, 1 110V receptacle

Period of Performance:

BASE YEAR: 01 April 2027 to 31 March 2028

OPTION YEAR 1: 01 April 2028 to 31 March 2029

OPTION YEAR 2: 01 April 2029 to 31 March 2030

OPTION YEAR 3: 01 April 2030 to 31 March 2031

OPTION YEAR 4: 01 April 2031 to 31 March 2032

CONTRACT PERIOD: BASE YEAR: April 1, 2027 – March 31, 2028 0001 Inpatient Dialysis Session- a singular, scheduled instance of applied extracorporeal blood purification utilizing a hemodialysis machine to support a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative). For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables, necessary to complete the above at James Mountain Inhofe VAMC, Tulsa, OK 225 $ $

0002 An Inpatient Dialysis Session - After Hours is any Inpatient Dialysis Session conducted between 8PM-6AM at James Mountain Inhofe VAMC, Tulsa, OK 81 $ $

0003 DELAY Initiation Due to Hospital Issues, Inpatient Dialysis Treatment at James Mountain Inhofe VAMC, Tulsa, OK 126 $ $

CONTRACT OPTION YEAR ONE GRAND TOTAL $

Contract period: OY1 April 1, 2028 – March 31, 2029 1001 Inpatient Dialysis Session- a singular, scheduled instance of applied extracorporeal blood purification utilizing a hemodialysis machine to support a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative). For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables, necessary to complete the above at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 232 $ $

1002 An Inpatient Dialysis Session - After Hours is any Inpatient Dialysis Session conducted between 8PM-6AM at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 83 $ $

1003 DELAY Initiation Due to Hospital Issues, Inpatient Dialysis Treatment at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 130 $ $

CONTRACT OPTION YEAR TWO GRAND TOTAL $

Contract period: OY2 April 1, 2029 – March 31, 2030 2001 Inpatient Dialysis Session- a singular, scheduled instance of applied extracorporeal blood purification utilizing a hemodialysis machine to support a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative). For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables, necessary to complete the above at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 239 $ $

2002 An Inpatient Dialysis Session - After Hours is any Inpatient Dialysis Session conducted between 8PM-6AM at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 86 $ $

2003 DELAY Initiation Due to Hospital Issues, Inpatient Dialysis Treatment at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 134 $ $

CONTRACT OPTION YEAR THREE GRAND TOTAL $

Contract period: OY3 April 1, 2030– March 31, 2031

3001 Inpatient Dialysis Session- a singular, scheduled instance of applied extracorporeal blood purification utilizing a hemodialysis machine to support a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative). For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables, necessary to complete the above at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 246 $ $

3002 An Inpatient Dialysis Session - After Hours is any Inpatient Dialysis Session conducted between 8PM-6AM at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 89 $ $

3003 DELAY Initiation Due to Hospital Issues, Inpatient Dialysis Treatment at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 138 $ $

CONTRACT OPTION YEAR FOUR GRAND TOTAL $

Contract period: OY4 April 1, 2031 – March 31, 2032 4001 Inpatient Dialysis Session- a singular, scheduled instance of applied extracorporeal blood purification utilizing a hemodialysis machine to support a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative). For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables, necessary to complete the above at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 253 $ $

4002 An Inpatient Dialysis Session - After Hours is any Inpatient Dialysis Session conducted between 8PM-6AM at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 91 $ $

4003 DELAY Initiation Due to Hospital Issues, Inpatient Dialysis Treatment at James Mountain Inhofe VAMC, Tulsa, OK (Max QTY) 142 $ $

CONTRACT OPTION YEAR FIVE GRAND TOTAL $

Contract Total $

PERFORMANCE WORK STATEMENT – Inpatient Dialysis Services

1. GENERAL

1.1 Services Provided: The Contractor shall provide qualified dialysis nursing and technical personnel and dialysis equipment on site in accordance with the specifications contained herein to support inpatient dialysis services for beneficiaries of the Department of Veterans Affairs (VA) and the James Mountain Inhofe Veterans Affairs Medical Center, Tulsa, Oklahoma.

1.2 Scope of Services: Contractor personnel shall support the implementation and completion of dialysis sessions, specifically:

1.2.1 Intermittent Hemodialysis (IHD)

1.2.2 Prolonged Intermittent Renal Replacement Therapy (PIRRT)

1.3 Definition of Dialysis “session”: A singular, scheduled instance of applied extracorporeal blood purification, utilizing a hemodialysis machine, to provide therapeutic support for a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative).

For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables necessary to complete the above.

Up to 8 hours for IHD and 14 hours for PIRRT shall comprise a single session.

1.4 Medical Supervision: All inpatient dialysis services shall be performed under the medical direction and supervision of VA-employed nephrologists. Contractor personnel do not function as independent practitioners and shall execute treatments per physician orders and established facility protocols.

1.5 Place of Performance: Contractor shall furnish services at James Mountain Inhofe Veterans Affairs Medical Center, 440 S Houston Ave, Tulsa, OK 74127.

1.6 Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority.

1.7 Policy/Directives/Handbooks: The contractor shall be subject to the following policies:

1.7.1 VA Directive 1663: Health Care Resources (HCR) Contracting

1.7.2 VHA Directive 1003.04: VHA Patient Advocacy

1.7.3 VHA Directive 1053: Chronic Kidney Disease Prevention, Early Recognition, and Management

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

1.7.5 VHA Directive 1100.20: Credentialing of Health Care Providers

1.7.6 VHA Directive 1192.01: Seasonal Influenza Vaccination Program

1.7.7 VHA Directive 1605.01: Privacy and Release of Information

1.7.8 VHA Directive 1907.01: VHA Health Information Management and Health Records

1.7.9 VHA Handbook 1042.01: Criteria and Standards for VA Dialysis Programs

1.7.10 Privacy Act of 1974 (5 U.S.C. 552a) as amended

1.7.11 HIPAA regulations (45 C.F.R. Parts 160, 162, and 164)

2. QUALIFICATIONS

2.1 Dialysis Registered Nurse (RN) Requirements

2.1.1 Licensure: Current, full, and unrestricted license to practice as a Registered Nurse in any State, Territory, or Commonwealth of the United States or the District of Columbia.

2.1.2 Certification: Certified Dialysis Nurse (CDN) or Certified Nephrology Nurse (CNN) certification required, or documentation of eligibility with commitment to obtain certification within 12 months of contract start.

2.1.3 Life Support: Current Basic Life Support (BLS) certification required. ACLS preferred.

2.1.4 Competencies: Demonstrated competency in:

2.1.4.1 Hemodialysis initiation, monitoring, and termination

2.1.4.2 Vascular access assessment and cannulation

2.1.4.3 Recognition and management of dialysis complications

2.1.4.4 Patient assessment specific to dialysis population

2.1.4.5 Operation of dialysis equipment

2.2 Biomedical Technician Requirements

2.2.1 Certification: Certified Biomedical Equipment Technician (CBET) or equivalent certification required.

2.2.2 Training: Manufacturer-specific training on dialysis machines in use at the facility. Training on water treatment and reverse osmosis systems.

2.2.3 Competencies: Demonstrated competency in:

2.2.3.1 Dialysis machine preventive maintenance and repair

2.2.3.2 Water treatment system maintenance

2.2.3.3 RO unit calibration and maintenance

2.2.3.4 Equipment troubleshooting and documentation

2.2.3.5 Quality assurance testing and documentation

2.3 Training Requirements

The Contractor shall ensure all personnel complete required training per Contractor's internal policies and applicable regulatory requirements. This shall specifically include a generic self-study bloodborne pathogen training for all Contractor personnel. Training curricula, competency verification, and documentation shall be the responsibility of the Contractor.

VA mandatory training (TMS courses) will be coordinated through the COR. See Appendix B for VA mandatory training requirements.

2.4 Immunization and Infection Control Measures

Contractor shall provide proof of the following for all personnel within five (5) calendar days after contract award:

2.4.1 Negative TB test (TST or IGRA) per CDC guidance

2.4.2 Measles, Mumps, Rubella immunity

2.4.3 Varicella immunity

2.4.4 Tdap vaccination

2.4.5 Annual influenza vaccination (or mask requirement if contraindicated)

2.4.6 COVID-19 vaccination in accordance with current VA and facility guidelines

2.4.7 Hepatitis B vaccination series and surface antigen test results

2.4.8 Bloodborne pathogen training completion

OSHA Bloodborne Pathogens: Contractor shall provide evidence of completing and passing generic self-study bloodborne pathogen training for all Contractor personnel; 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.

The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guidelines for Infection Control in health care personnel for disease control. Contractor shall provide follow-up documentation of clearance to return to the workplace prior to their return.

2.5 Credentialing

Credentialing shall be completed in accordance with VHA Directive 1100.20. The Contractor is responsible for ensuring proposed personnel possess requisite credentials. No services shall be provided prior to credentialling approval. If credentials are suspended or revoked, the Contractor shall furnish an acceptable substitute at no additional cost to the government.

2.6 Conflict of Interest

The Contractor and all Contractor personnel 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 its 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 VAAR provision 852.209-70 Organizational Conflicts of Interest.

2.7 Citizenship Requirements

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.

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien or foreign national non-immigrant who is in violation of 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.

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; and shall form the basis for termination of this contract for breach.

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. The Contractor agrees to obtain a similar certification from its subcontractors.

3. HOURS OF OPERATION AND SCHEDULING

3.1 JMI Operating Hours

The James Mountain Inhofe VHAMC will operate 24 hours a day, 365 days per year.

3.2 Coverage Availability

Contractor personnel shall be available at all times to include evenings, weekends, and federal holidays. Contractor personnel designated “available for service” (should there be such a designation internal to the Contractor) must be available by phone within 15 minutes and on-site within 4 hours.

3.3 Compensation Adjustments

Financial adjustments for federal holidays and after-hours sessions will be paid at 120% the contract rate for a standard session and specified in the pricing schedule.

3.3.1 After-Hours Session: Any session conducted with more than 25% of the session time falling between 2000 and 0600.

3.3.2 Federal Holidays: The following holidays are observed:

• New Year's Day

• Martin Luther King Jr. Day

• Presidents' Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared a national holiday

4. CONTRACTOR RESPONSIBILITIES

4.1 Clinical Personnel

The Contractor shall provide personnel who are competent, qualified per this PWS, and adequately trained to perform assigned duties. Personnel shall sign in/out when in attendance.

Time sheets will be used by the COR to confirm hours and services against invoices.

4.2 Standards of Care

Services shall meet or exceed community standards and comply with:

4.2.1 VHA Handbook 1042.01: Criteria and Standards for VA Dialysis Programs

4.2.2 The Joint Commission (TJC) standards

4.2.3 National Kidney Foundation guidelines

4.2.4 KDIGO clinical practice guidelines

4.2.5 Facility-specific dialysis protocols

4.3 Scope of Nursing Services

Dialysis RN responsibilities include, but are not limited to:

4.3.1 Pre-dialysis patient assessment including vital signs, access assessment, and review of physician orders

4.3.2 Dialysis machine setup and programming per physician prescription

4.3.3 Vascular access cannulation or catheter connection

4.3.4 Dialysis session initiation, monitoring, and termination

4.3.5 Intradialytic monitoring and intervention for complications

4.3.6 Coordination with VA floor nurses for medication administration

4.3.7 Documentation of dialysis treatments in the VA electronic health record

4.3.8 Patient and family education regarding dialysis care

4.3.9 Supervision of PCTs (where applicable)

4.3.10 Communication with VA nephrologists regarding patient status and concerns

4.4 Scope of Biomedical Services

Biomedical Technician responsibilities include, but are not limited to:

4.4.1 Preventive maintenance of dialysis machines per manufacturer specifications

4.4.2 Water treatment system monitoring and maintenance

4.4.3 RO unit calibration, maintenance, and quality testing

4.4.4 Equipment troubleshooting and repair

4.4.5 Documentation of all maintenance activities

4.4.6 Participation in quarterly QA reviews

4.4.7 Coordination with VA Clinical Engineering as needed

4.5 Medical Records

Contractor personnel providing services shall comply with Privacy Act (5 U.S.C. 552a), FOIA, HIPAA, and all VA medical records policies. All dialysis documentation shall be completed in the VA electronic health record system. Contractor-generated VA patient records are property of the

VA.

5. PERSONNEL MANAGEMENT

5.1 Personnel Substitutions/Additions

Should the contractor require the introduction of new registered nurse/patient-care technician (if utilized) for inclusion in the execution of services to be rendered, the contractor will submit written notice to the CO and COR at least ninety-days (90) prior to any participation in a VA session. Upon receiving notification, the CO or their designee will initiate credentialing and all IT set-up for the contractor's new employee.

5.2 Contingency Plan

Because continuity of care is essential, the Contractor shall maintain a contingency plan for personnel absences. If a scheduled staff member is unable to complete an assigned shift, the Contractor shall provide replacement coverage within 2 hours and notify the COR immediately.

5.3 Conduct Standards

The Government reserves the right to refuse acceptance of any Contractor personnel if personal or professional conduct jeopardizes patient care or interferes with facility operations.

Breaches include intoxication, drug use, theft, patient abuse, dereliction, negligence, or conduct resulting in formal complaints.

6. GENERAL PROVISIONS

6.1 Non-Personal Healthcare Services

6.1.1 The parties agree that the Contractor and all Contractor’s personnel shall not be considered VA employees for any purpose.

6.2 Indemnification

6.2.1 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.

6.3 Inherent Government Functions

6.3.1 Contractor and Contractor’s personnel 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.

6.4 No Employee Status

6.4.1 The Contractor shall be responsible for protecting Contractor’s personnel 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:

• Workers’ compensation

• Professional liability insurance

• Health examinations

• Income tax withholding, and

• Social security payments.

6.5 Tort Liability

6.5.1 The Federal Tort Claims Act does not cover Contractor or contract personnel.

When a Contractor or Contractor’s personnel have been identified as a participant 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 personnel(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

6.6 Conflict of Interest

6.6.1 The Contractor and all Contractor’s personnel 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 its 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.

6.7 OIG Exclusion Verification

6.7.1 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 payments due to fraud and/or abuse of the Medicare and Medicaid programs.

6.7.2 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 personnel and affiliates 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 http://oig.hhs.gov/exclusions/index.asp the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

6.7.3 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.

6.8 HIPAA/Privacy Act Compliance

6.8.1 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

7. Acronyms/Definitions:

7.1 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.

7.1.1 ACGME: Accreditation Council for Graduate Medical Education

7.1.2 ACLS: Advanced Cardiac Life Support

7.1.3 AOD: Admitting Officer of the Day

7.1.4 BLS: Basic Life Support

7.1.5 CCNE: Commission on Collegiate Nursing Education:

www.aacn.nche.edu/accreditation

7.1.6 CDC: Centers for Disease Control and Prevention

7.1.7 CDR: Contract Discrepancy Report

7.1.8 CEU: Certified Education Unit

7.1.9 CME: Continuing Medical Education

7.1.10 CMS: Centers for Medicare and Medicaid Services

7.1.11 CO: Contracting Officer: 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.

7.1.12 COR: Contracting Officer’s Representative: 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 http://www.aacn.nche.edu/accreditation of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

7.1.13 COS: Chief of Staff

7.1.14 CPARS: Contractor Performance Assessment Reporting System

7.1.15 Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

7.1.16 DEA: Drug Enforcement Agency

7.1.17 Dialysis “session”: A singular, scheduled instance of applied extracorporeal blood purification, utilizing a hemodialysis machine, to provide therapeutic support for a VA patient with an appropriate indication. The treatment is done at the direction of a board certified/eligible VA privileged nephrologist(s) (or their supervised representative).

For the purposes of this contract, the term "session" and the fee for such shall include the presence and time of an appropriately trained nurse, the provision of agreed upon dialysis machinery and all ancillary items, including consumables necessary to complete the above.

7.1.18 ED: Emergency Department

7.1.19 EHR: Electronic Health Record - electronic health record system used by the

VA

7.1.20 FSMB: Federation of State Medical Boards

7.1.21 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.

7.1.22 HHS: Department of Health and Human Services

7.1.23 HIPAA: Health Insurance Portability and Accountability Act

7.1.24 HR: Human Resources

7.1.25 ISO: Information Security Officer

7.1.26 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.

7.1.27 MOD: Medical Officer of the Day

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

7.1.29 NKF: National Kidney Foundation

7.1.30 NLNAC: National League for Nursing Accrediting Commission. www.nlnac.org

7.1.31 Non-Contract Provider: any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors

7.1.32 NP: Nurse Practitioner

7.1.33 NPPES: National Plan and Provider Enumeration System

7.1.34 OPPE/FPPE- Ongoing professional practice evaluation/ Focused professional practice evaluation

7.1.35 PA: Physician Assistant

7.1.36 PALS: Pediatric Advanced Life Support

7.1.37 POP: Period of Performance

7.1.38 PPD: Purified Protein Derivative

7.1.39 PWS: Performance Work Statement

7.1.40 Clinical Privileging: Clinical Privileging is the process by which a practitioner, 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.

7.1.41 QA/QI: Quality Assurance/Quality Improvement

7.1.42 QM/PI: Quality Management/Performance Improvement

7.1.43 QASP: Quality Assurance Surveillance Plan

7.1.44 VHA: Veterans’ Health Administration

7.1.45 VISN: Veterans Integrated Services Network

7.1.46 VistA Veterans Information Systems Technology Architecture

7.1.47 VETPro: is 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.

8. GOVERNMENT RESPONSIBILITIES

8.1 VA Support Personnel, Services or Equipment: The VA shall furnish a computer and workspace to use such so as to provide contractor access to the VA electronic medical record to document treatment.

8.2 CO RESPONSIBILITIES:

DRAFT

https://www.kidney.org/professionals/guidelines/guidelines_commentaries http://www.nlnac.org/

8.2.1 CO:

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

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

8.2.1.3 In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan;

increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

8.3 COR RESPONSIBILITIES:

8.3.1 The COR for this contract is:

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

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

8.3.1.3 The COR will maintain a record-keeping system of services by: monthly electronic record auditing and recording of data into spreadsheet for review and reports. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices.

Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

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

All contract administration functions will be retained by the VA.

9. SPECIAL CONTRACT REQUIREMENTS

9.1 Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

9.1.1 The following are brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly’; annually, etc.

identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

What Submit as noted Submit To Quality Control Plan: Description and reporting reflecting the contractor’s plan for meeting contract requirements and performance standards

Upon proposal and as frequently as indicated in the performance standards.

Contracting Officer

Copy of Subcontracting Plan is required for all large businesses. Copy of Contractor Certification Statement if no subcontracting possibilities exist.

Upon proposal and as updated

Contracting Officer

Copies of all state licenses, certifications, to include primary source verification of all licensed and certified staff

Upon proposal and upon renewal of licenses and upon renewal of option periods or change of key personnel.

Contracting Officer with proposal;

renewal submitted to

VETPRO

system.

Certification that staff list has been compared to OIG list

Upon proposal and upon new hires.

Contracting Officer

Proof of Indemnification and Medical Liability Insurance

Upon proposal and upon renewals.

Contracting Officer

Certificates of Completion for Cyber Security and Patient Privacy Training Courses

Before receiving an account on VA Network and annual training and new hires.

Contracting Officer

ACLS or BLS Certification Upon award and every two years after award.

COR

Contingency plan for replacing key personnel to maintain services as required under the terms of the contract

Upon proposal and as updated

COR

Immunization and Infection Control documentation listed in PWS Section 2.5

Upon award and every year after award.

COR

9.2 Billing:

9.2.1 Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than twenty-eight (28) days after services were rendered. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

Name and Address of Contractor Invoice Date and Invoice Number Contract Number and Purchase/Task Order Number Date of Service Contractor’s personnel (Name of Contractor’s employee) Hourly Rate Quantity of hours worked Total price

9.3 Vendor Electronic Invoice Submission Methods:

9.3.1 Invoices will be electronically submitted to the Tungsten website at https://www.tungstenautomation.com/. Tungsten Automation direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-

up) Tungsten Automation will confirm your Taxpayer ID Number with the VA- FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. To successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten Automation to the VA-FSC should mirror the current submission of Invoice. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). Payment will only be made for actual services rendered. Payments shall be made monthly in arrears. The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. The contractor shall be reimbursed upon receipt of a proper invoice. For additional information, please contact:

9.3.2 Tungsten Support

Phone: 1-877-489-6135 Website: https://www.tungstenautomation.com/

9.3.3 Department of Veterans Affairs Financial Service Center https://www.fsc.va.gov/einvoice.asp

9.3.4 Reduction in Services: This is a fixed quantity contract for a specified number of hours. If, at the end of the period of performance, the government has not utilized the total number of hours required under this contract because of a change in its requirements, the parties agree that they will attempt to negotiate in good faith a contract modification reducing the scope of the contract with a corresponding

DRAFT

https://www.tungstenautomation.com/ https://www.tungstenautomation.com/ https://www.fsc.va.gov/einvoice.asp adjustment in the total contract price. In no event will the VA pay for hours that exceed the total number of hours specified in the contract for the period of performance.

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

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

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

9.4 Non-Personal Healthcare Services

9.4.1 Non-Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s personnel shall not be considered VA employees for any purpose.

9.5 Indemnification

9.5.1 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.

9.6 Inherent Government Functions

9.6.1 Inherent Government Functions: Contractor and Contractor’s personnel 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.

9.7 No Employee Status

9.7.1 No Employee status: The Contractor shall be responsible for protecting

Contractor’s personnel 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:

• Workers’ compensation

• Professional liability insurance

• Health examinations

• Income tax withholding, and

• Social security payments.

9.8 Tort Liability

9.8.1 Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel. When a Contractor or Contractor’s personnel have been identified as a participant 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 personnel(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

9.9 Conflict of Interest

9.9.1 Conflict of Interest: The Contractor and all Contractor’s personnel 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 its 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.

9.10 OIG Exclusion Verification

9.10.1 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 payments due to fraud and/or abuse of the Medicare and Medicaid programs.

9.10.2 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 personnel and affiliates 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 http://oig.hhs.gov/exclusions/index.asp the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

9.10.3 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.

9.11 HIPAA/Privacy Act Compliance

9.11.1 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.