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36C25621R0111 Section E

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL

BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b.

RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT

ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES W

HICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND

TITLE OF SIGNER (TYPE OR PRINT)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

Will be issued via Task Orders 36C25621R0111 05-0 -2021 Billy R. Morris 501-257-1025 05-20-2021 15:00

CDT

Department of Veterans Affairs

NCO 16

Central Arkansas Veterans HCS 2200 Fort Roots Drive, Bldg 41, Room 200 North Little Rock AR 72114 X 621492 $41.5 Million N/A X Department of Veterans Affairs Veterans Health Care System of the Ozark 2200 Fort Roots Drive 1100 North College Ave Fayetteville AR 72703 Department of Veterans Affairs Chief, A&MM (90C/NLR) Central Arkansas Veterans HCS 2200 Fort Roots Drive, Bldg 41, Room 200 North Little Rock AR 72114 1706

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp

Invoice Setup Information 1 -877-489-6135 Invoice must be submitted electronically 1-877-489-6135

THIS REQUIREMENT IS A SMALL BUSINESS SET ASIDE

Hemodialysis services are needed for Veteran’s Health Care System of the Ozarks Hospital, 1100 North College Ave., Fayetteville, Arkansas 72703 Period of Performance: (5 Year Firm with Ordering Periods 06/01/2021 – 09/30/2021 is the Base Period.

See Schedule on Pgs 6 - 8.

X X X Billy R. Morris Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.2 PRICE SCHEDULE4
SECTION C – Contract Clauses32
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)32
C.2 52.216-18 ORDERING (AUG 2020)38
C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)38
C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)39
C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)39
C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)39
C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)40
C.8 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)41
C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)42
C.10 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)43
C.11 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)44
C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021)46
SECTION D – CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS54
SECTION E - SOLICITATION PROVISIONS55
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)55
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)62
E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)64
E.4 52.216-1 TYPE OF CONTRACT (APR 1984)66
E.5 52.222-5 CONSTRUCTION WAGE RATE REQUIREMENTS—SECONDARY SITE OF THE WORK (MAY 2014)66
E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)66
E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)67
E.8 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)67
E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021)70

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256 Department of Veterans Affairs

NCO 16

Central Arkansas Veterans HCS 2200 Fort Roots Drive, Bldg 41, Room 200 North Little Rock AR 72114 1706

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

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Monthly In Arrears

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be 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:

AMENDMENT NO
DATE

B.2 PRICE SCHEDULE

This is a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract type with a five (5) year ordering period. Base and Ordering Periods of Performance are estimated subject to the effective date of award.

Contract Minimum: $15,000.00 Contract Maximum: $4,000,000.00 Contractor to provide inpatient dialysis services as defined in the Performance Work Statement and throughout this contract, for eligible beneficiaries as authorized by the VA Medical Center. Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall be subject to review by the VA Facility Chief of Staff and approval by the VA Facility Director. Each person assigned to work under this contract shall be licensed by the appropriate licensing body within the applicable state.

1. Pricing shall be based on a percent of the CMS Medicare Program’s prospective payment system for the respective dialysis services contract line item number (CLIN), and any authorized Current Procedural Terminology (CPT) that applies to the type of services required for that patient. All services will be paid at the contract percent of the CMS Medicare Program for its respective CLIN. The prices shall be all-inclusive of equipment, facility, nursing, technical personnel, laboratory testing, drugs, supplies and professional services (social work and dietary). CMS Medicare Program pricing is the basis from which all claims will be submitted and paid.

2. The CMS Medicare Program allowed amount will be computed in accordance with the rules (1) promulgated by the Centers for Medicare and Medicaid Services (CMS) for the specific Medicare geographic area where the services are provided (2) in effect at the time of the delivery of service, and (3) including, but not limited to, all CMS Medicare Program payment components (e.g. outliers, etc.) multiplied by the contract percent of Medicare.

3. Inpatient dialysis services are required at the Veterans Health Care System of the Ozarks Hospital, 1100 North College Avenue, Fayetteville, Arkansas.

4. Period of Performance: (5 Year Firm with Ordering Periods) 06/01/2021 (or date of Award, whichever is later) – 09/30/2025

Base Ordering Period:June 1, 2021 – September 30, 2021
Ordering Period 1:October 1, 2021 – September 30, 2022
Ordering Period 2:October 1, 2022 – September 30, 2023
Ordering Period 3:October 1, 2023 – September 30, 2024
Ordering Period 4:October 1, 2024 – September 30, 2025

BASE ORDERING PERIOD – June 1, 2021 – September 30, 2021

CLIN
1. CATEGORY OF CARE
ESTIMATED TIMES
RATE
ESTIMATED COST ($)
0001
Inpatient Hemodialysis Treatment 24/7
80
$
$
0002
Inpatient Consult without patient contact
18
$
$
0003
Inpatient Consult with patient contact
3
$
$
0004
RN Dialysis Daytime 7a – 5p
85
$
$
0005
RN Dialysis Nightime 5p – 7a/Weekends
34
$
$
0006
Nephrologist On Call
122
$
$
0007
Dialysis Program Inventory Management & Compliance
40
$
$

TOTAL ESTIMATED COST

Ordering Period 1: October 1, 2021 – September 30, 2022

CLIN
1. CATEGORY OF CARE
ESTIMATED TIMES
RATE
ESTIMATED COST ($)
0001
Inpatient Hemodialysis Treatment 24/7
180
$
$
0002
Inpatient Consult without patient contact
35
$
$
0003
Inpatient Consult with patient contact
6
$
$
0004
RN Dialysis Daytime 7a – 5p
260
$
$
0005
RN Dialysis Nightime 5p – 7a/Weekends
105
$
$
0006
Nephrologist On Call
365
$
$
0007
Dialysis Program Inventory Management & Compliance
180
$
$

TOTAL ESTIMATED COST

Ordering Period 2: October 1, 2022 – September 30, 2023

CLIN
1. CATEGORY OF CARE
ESTIMATED TIMES
RATE
ESTIMATED COST ($)
0001
Inpatient Hemodialysis Treatment 24/7
180
$
$
0002
Inpatient Consult without patient contact
35
$
$
0003
Inpatient Consult with patient contact
6
$
$
0004
RN Dialysis Daytime 7a – 5p
260
$
$
0005
RN Dialysis Nightime 5p – 7a/Weekends
105
$
$
0006
Nephrologist On Call
365
$
$
0007
Dialysis Program Inventory Management & Compliance
180
$
$

TOTAL ESTIMATED COST

Ordering Period 3: October 1, 2023 – September 30, 2024

CLIN
1. CATEGORY OF CARE
ESTIMATED TIMES
RATE
ESTIMATED COST ($)
0001
Inpatient Hemodialysis Treatment 24/7
180
$
$
0002
Inpatient Consult without patient contact
35
$
$
0003
Inpatient Consult with patient contact
6
$
$
0004
RN Dialysis Daytime 7a – 5p
260
$
$
0005
RN Dialysis Nightime 5p – 7a/Weekends
105
$
$
0006
Nephrologist On Call
365
$
$
0007
Dialysis Program Inventory Management & Compliance
180
$
$

TOTAL ESTIMATED COST

Ordering Period 4: October 1, 2024 – September 30, 2025

CLIN
1. CATEGORY OF CARE
ESTIMATED TIMES
RATE
ESTIMATED COST ($)
0001
Inpatient Hemodialysis Treatment 24/7
180
$
$
0002
Inpatient Consult without patient contact
35
$
$
0003
Inpatient Consult with patient contact
6
$
$
0004
RN Dialysis Daytime 7a – 5p
260
$
$
0005
RN Dialysis Nightime 5p – 7a/Weekends
105
$
$
0006
Nephrologist On Call
365
$
$
0007
Dialysis Program Inventory Management & Compliance
180
$
$

TOTAL ESTIMATED COST

** Changes to the contract can only be made by a written modification which is formally executed by the contractor and the Contracting Officer.

Orders shall be issued only by the Contracting Officer.

All unit prices shall be a fixed price and all inclusive.

The government reserves the right to negotiate additional staffing in the event patient demand increases beyond stated estimated quantities.

ORDERS: This is a Fixed Price (FP) Indefinite Delivery/Indefinite Quantity (IDIQ) contract (see FAR 52.216-22).

Ordering Procedures:

a. This contract type allows the Department of Veteran Affairs Network Contracting Office 16 (NCO 16) contracting officers to place orders with the contractor on an as needed basis, in accordance with the FAR Clauses 52.216-18, Ordering. NCO 16 will obligate the funding and order the services by issuing a task order.

b. The contractor shall initiate work when, so directed by a Task Order. No work under any Task Order shall be performed unless specifically authorized by the contracting officer.

Approval of a Task Order shall not constitute approval to exceed any item listed in the contract or general provisions of the contract. The contractor shall not exceed the task order amount or change the task order without prior written approval of the contracting officer.

c. Task orders within scope of the IDIQ contract will be issued unilaterally in accordance with the IDIQ Contract terms and conditions and bilaterally when change in terms and conditions is negotiated in accordance with contract clauses FAR 52.212-4 (c), FAR 52.216-18, FAR 52.216-19 and FAR 52.216-22.

d. Task order pricing for services will be based on IDIQ prices based on negotiated priced contract line items as outlined in B.2 Schedule of Services section in this single award IDIQ contract.

e. Contractor is required to deliver services in accordance with the task order terms and conditions during the task order specified period of performance.

f. The NCO 16 Contracting Officer is the only authorized official to issue task orders under this IDIQ Contract.

g. Task order prices shall be Fixed-Price (FP) as agreed to in the contractor’s schedule and individually funded.

h. Each task order shall have an established period of performance or delivery date. Individual Task order shall not exceed a 12-month period.

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL INFORMATION

Objective: The Department of Veterans Affairs (VA) has a requirement to purchase inpatient dialysis services from community-based dialysis service providers. For the purpose of this document a Veteran is defined as a VA eligible dialysis patient.

The goals of this contract are to:

A. Realize cost saving through the utilization of consistent billing practices;

B. Ensure quality driven services;

C. Maintain and augment the VA’s ability to provide these services to Veterans in current and future years by providing improved access to care.

The contractor shall meet the requirements of this contract and be in compliance with Centers for Medicare and Medicaid Services (CMS) quality standards. The contractor shall provide, deliver, supervise and monitor inpatient dialysis services to Veterans with the Veterans Health Care System of the Ozarks Hospital located at 1100 North College Avenue, Fayetteville, Arkansas. Inpatient dialysis services shall utilize contractor resources, contractor owned and maintained equipment, contractor staff, clinical and technical staff and the contractor equipment necessary or required for inpatient dialysis services. The contractor shall provide the services and associated health care in a manner consistent with the clinical needs of the Veteran and extend the same or superior standards of quality care as delivered to the facility’s non-VA patients.

Applicable Federal State and Local Laws: During the course of this contract, the contractor must comply with all federal, state and local laws and regulations.

The contractor shall utilize Registered Nurses to perform all inpatient treatments. Each nurse performing those services shall be responsible for the composition of the dialysate, administering IV solutions, blood and blood products and medications as ordered into the dialyzer blood line system necessary for treatments. Contractor shall conduct all equipment water testing and equipment maintenance, including cleaning of the dialysis equipment. Contractor shall be responsible for patient monitoring during the procedure.

2. SERVICE AREA

Inpatient dialysis services are required at the Veterans Health Care System of the Ozarks Hospital, 1100 North College Avenue, Fayetteville, Arkansas.

A. Policy/Handbooks: The contractor shall be subject to the following policies, including any subsequent updates during the period of performance.

i. VHA Handbook 1100.17: National Practitioner Data Bank Reports: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

ii. VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

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

iv. VHA Handbook 1907.01: Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

v. VHA Directive 1003.04: VHA Patient Advocacy: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

vi. VHA Directive 1088: Communicating Test Results to Providers and Patients: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

vii. VHA Directive 1192.01: Seasonal Influenza Prevention Program: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8948

viii. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

ix. VHA Directive 2012-030 Credentialing of Health Care Professionals: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

x. VA Directive 1663: Health Care Resources Contracting – Buying: https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

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

i. ASN: American Society of Nephrology http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines

ii. ASH: American Society of Hematology/Nephrology

iii. ACGME: Accreditation Council for Graduate Medical Education

iv. ACLS: Advanced Cardiac Life Support

v. AOD: Admitting Officer of the Day

vi. BLS: Basic Life Support

vii. CCNE: Commission on Collegiate Nursing Education: www.aacn.nche.edu/accreditation

viii. CDC: Centers for Disease Control and Prevention

ix. CDR: Contract Discrepancy Report

x. CEU: Certified Education Unit

xi. CME: Continuing Medical Education

xii. CMS: Centers for Medicare and Medicaid Services

xiii. 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.

xiv. 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.

xv. COS: Chief of Staff

xvi. CPARS: Contractor Performance Assessment Reporting System

xvii. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

xviii. DEA: Drug Enforcement Agency

xix. ED: Emergency Department

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

xxi. FSMB: Federation of State Medical Boards

xxii. Full Time Equivalent (FTE): VA’s definition for full time- working the equivalent of 80 hours every two weeks, 2080 hours per year. In calculating FTE, any hours not worked on national holidays shall not be included.

xxiii. HHS: Department of Health and Human Services

xxiv. HIPAA: Health Insurance Portability and Accountability Act

xxv. HR: Human Resources

xxvi. ISO: Information Security Officer

xxvii. 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.

xxviii. MOD: Medical Officer of the Day

xxix. National Provider Identifier (NPI): 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).

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

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

xxxii. NP: Nurse Practitioner xxxiii. NPPES: National Plan and Provider Enumeration System

xxxiv. PA: Physician Assistant

xxxv. PALS: Pediatric Advanced Life Support

xxxvi. POP: Period of Performance xxxvii. PPD: Purified Protein Derivative xxxviii. PWS: Performance Work Statement

xxxix. Privileging (Clinical Privileging): 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.

xl. QA/QI: Quality Assurance/Quality Improvement xli. QM/PI: Quality Management/Performance Improvement xlii. QASP: Quality Assurance Surveillance Plan xliii. Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

xliv. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

xlv. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

xlvi. VetPro: a federal web-based credentialing program for healthcare providers.

xlvii. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Fayetteville, Arkansas Medical Center (Veterans Health Care System of the Ozarks Hospital).

QUALIFICATIONS:

A. Staff/Facility

i. License: The Contractor’s physician(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia) when services are performed onsite on VA property.

All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s physician(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.

ii. Board Certification: All contract Nephrology provider(s)shall be Board Certified by the American Board of Internal Medicine in Nephrology http://www.abim.org/specialty/nephrology.aspx , and be currently certified in Basic Life Support (BLS) Advanced Cardiac Life Support (ACLS) or equivalency. All continuing education courses required for maintaining certification must always be kept up to date . Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

iii. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 and VHA Directive 2012-030 referenced above. The Contractor is responsible to ensure that proposed provider (s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract provider(s) prior to obtaining approval by the VAMC Professional Standards Board, Medical Executive Board and Medical Center Director.

· If a Contractor’s physician(s) is 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.

iv. Technical Proficiency: Contractor’s physician(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’s physicians shall have knowledge of professional care theories, principles, practices, and procedures to perform assignments of Nephrology patient/critically ill patient population. Contractor’s physician shall demonstrate knowledge of growth and development, and pathophysiology of disease processes specific to the critical care/nephrology population Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for Contractor’s physician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

v. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contractor’s physician(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract physician(s).

vi. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor

Training (The following training is mandatory per VHACO for Contracted Physicians)
Frequency (once a year, etc)
Annual Hours
Active Threat Training
Annually
1

Blood Administration: Complications

Annually

Government Ethics
Annually
1

Moderate Sedation In-Service Training

Annually

Prevention of Workplace Harassment/No Fear Act

Annually

VA Core Values Training (ICARE Recommitment)

Annually

VA Privacy and Information Security Awareness and Rules of Behavior

Annually

VHA Privacy and HIPAA Focused Training

Annually

ACLS/BLS
Annually
1
Patient Safety
Annually
1
Patient Rights
Annually
1
Patient Abuse
Annually
1

Prevention/Management of Disruptive Behavior/Violence Prevention Level I

Suicide Prevention: Suicide Risk Management Training for Clinicians

SUX Infection Control and Blood Borne Pathogens

Annually

CPRS
Annually
1
VISTA Imaging
Annually
1

vii. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians 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.

1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) {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. The TST or IGRA testing shall be repeated annually.

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

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

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

5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician 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}.

6. 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 physician(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.

7. The VAMC 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.

viii. National Provider Identifier (NPI): 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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

ix. Conflict of Interest: The Contractor and all Contractor’s physician(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.

x. Citizenship related Requirements:

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. 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.

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.

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.

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.

xi. 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.

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 physician(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. 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.

B. 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 Handbook 1100.19 and VHA Directive 2012-030. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC 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.

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

D. 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.

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

F. Inherent Government Functions: Contractor and Contractor’s physician(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.

G. No Employee status: The Contractor shall be responsible for protecting Contractor’s physician(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:

i. Workers’ compensation

ii. Professional liability insurance

iii. Health examinations

iv. Income tax withholding, and

v. Social security payments.

H. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract provider(s). When a Contractor or contract provider (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 contract physician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

I. Key Personnel:

i. 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 physician is unable to complete an assigned shift, the contractor shall provide replacement physician coverage within 2 hours and notify the Contracting Office Representative (COR) at the Fayetteville VAMC immediately of the schedule change.

ii. 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 60 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 60 calendar days prior to making any permanent substitutions.

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 60 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. For temporary substitutions where the key person shall not be reporting to work for three 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.

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 physician(s), s/he may request, without cause, immediate replacement of said Contractor’s physician(s). The CO and COR shall deal with issues raised concerning Contractor’s physician(s) conduct. The final arbiter on questions of acceptability is the CO.

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

3. USUAL AND CUSTOMARY TREATMENT UTILIZATION

All treatment modalities delivered must be in accordance with the CMS Medicare Program treatment guidelines to include CMS’ Phase III End Stage Renal Disease (ESRD) Clinical Performance Measures. All treatments must be requested and authorized by the referring inpatient provider.

Inpatient Hemodialysis (HD) - Inpatient Hemodialysis treatment and technical services: Sunday through Saturday 24/7, on-call as needed basis to include Holidays

4. AUTHORIZATION (ORDERING) PROCESS

A. VA will use the Dialysis Inpatient Consult for ordering Inpatient Hemodialysis. The contractor shall utilize a licensed nephrologist to manage the dialysis and any dialysis related complications. Orders may be given by the contractor’s nephrologist to the contractor’s nurse over the phone; the nephrologist need not be physically present at the bedside during each treatment. However, the nephrologist shall be available via pager and cell phone at all times. Verbal/telephone orders must be signed by the nephrologist per VHSO facility policy. At the discretion of VHSO, the nephrologist may be asked to evaluate the patient in person through submission of an Inpatient Consult with patient contact.

B. Dialysis access will be placed by VHSO. Dialysis consent will be completed by VHSO prior to the dialysis treatment.

C. For emergency dialysis (to be available 24 hour per day, seven (7) days per week), the contractor shall respond (be on site at VHSO) within six (6) hours from placement of the dialysis access and the call from the ordering VHSO physician.

D. The VHSO physician will manage the patient’s primary medical and/or renal problems. Contractor physician personnel will manage the dialysis treatment.

E. Any emergencies (code blue, cardiac arrhythmia, respiratory failure, etc.) will be attended by the VHSO staff.

F. Contractor personnel shall report to Ward 2B Nurses station upon arrival at VHSO to obtain the Inpatient Dialysis room key. Inpatient dialysis will take place in the dedicated inpatient dialysis room 266 or in the ICU.

G. Contractor shall document the services provided via a paper hemodialysis flow sheet and CPRS (Computerized Patient Recordkeeping System- electronic health record system used by the VA), will maintain patient information, medical records, including results of tests, and will follow appropriate procedures to ensure the patient confidentiality rights are not violated in accordance with applicable state and federal confidentiality laws. In the event the nephrologist issues a verbal or telephone order to the registered nurse, that order will be written down and read back to the provider to assure accuracy. The order will be signed by the provider and faxed to VHSO within 24 hours to be scanned into the patients record per VHSO facility policy after the order is given.

H. The contractor will document the hemodialysis procedures on each patient treatment (duration of dialysis, type of dialysis used, any difficulty with the procedure on the hemodialysis flow sheet. Any ancillary reports will be completed as necessary. This will be in addition to notes of any notable change in a patient’s condition.

I. The use of disposable, single-use only items for providing service under this contract is mandatory. Fistula clamps are one-time use/disposable items and need to be supplied as such. It is not acceptable to use them and wipe down/clean them for reuse.

J. Contractor shall assure compliance with all relevant regulatory agencies and standards for their personnel, including but not limited to the Joint Commission (JC) or equivalent accreditation program, the Occupational Safety and Health Administration (OSHA), and the State of Arkansas, for all hemodialysis services rendered under this contract. If the contractor is not JC accredited, contractor shall provide documentation, upon request that ensures it has the resources to meet the quality requirements of the contract. Such documentation must be approved by the Chief, Quality Management.

5. CONTRACTOR EQUIPMENT

The contractor shall provide dialysis equipment and shall maintain and document all required preventative maintenance and repairs; shall comply with all relevant regulatory agencies and standards for its equipment; shall be responsible for monthly bacterial water testing and chemical water testing, and shall assure compliance with AAMI analysis guidelines; shall be responsible for quality assurance requirements related to bacterial cultures; and shall provide the VHSO with quarterly reports of preventative maintenance, biological testing, and monthly water quality testing results and all yearly reporting requirements. The Contractor will make corrections as needed to comply with VHSO policies, the Joint Commission Standards and additional accrediting bodies.

The contractor shall comply with all applicable requirements of Federal, State, and local hazardous waste regulations. Documentation related to waterlogs, equipment checks, culture results, temperature logs, and dialysis support supplies will be inventoried on a weekly basis and an inventory check list will be provided to the COR on a monthly basis. A copy of all required documentation will be kept in a separate binder in the dialysis unit and be readily available at all times to the appropriate VHSO personnel. The Contractor shall provide a copy of any additions to the documentation to the COR on a monthly basis.

6. INPATIENT HEMODIALYSIS TREATMENT-TECHNICAL SERVICE, PRICE PER TREATMENT

A. All hemodialysis treatments shall be billed and paid in accordance with the Technical Services Price per treatment (contract line items 1 and 2). The Price per treatment shall include all services, equipment, supplies, etc., that are necessary to furnish hemodialysis treatments.

B. Routine items and services related to the Inpatient Hemodialysis treatment included in the contract Price per treatment:

· Medically necessary dialysis equipment and dialysis support equipment;

· Purchase and delivery of all necessary dialysis supplies;

· All dialysis services furnished by the contractor’s staff.

· Flushing of dialysis access and any supplies used;

· Staff time used to administer non-routine parenteral items;

· All dialysates, artificial dialyzers, bloodlines, and other supplies;

· Dialysate additives (e.g. Bicarbonate);

· Cardiac monitoring;

· Dressing changes of dialysis catheter or peripheral dialysis access.

C. Drugs to be provided:

Apresoline (hydralazine)
Formulary Antiarrythmics
Formulary Insulins
Formulary Local Anesthetics
Mannitol
Dopamine
Formulary Pressor drugs
Lidocaine
Dephenhydramine
Solu-cortef (Hydrocortisone)
Lanoxin (Digoxin)
Formulary Antihypertensives
Glucose Tablets
Dextrose
Propranolol
Verapamil
Levophed
Non-Intravenous Antibiotics (when used at home by a patient to treat an infection of the catheter site)
Normal Saline
Heparin
Protamine
Epogen
Calcitriol
Activase

Medications prescribed as part of hemodialysis treatment will be administered by the contractor RN. This administration (contractor staff time) is covered in the Price per treatment and may not be billed separately.

D. Drugs that are used as a substitute for any of these items or are used to accomplish the same effect will be furnished by VHSO.

E. As part of the hemodialysis treatment, the contractor is responsible for monitoring access, and if occlusions occur, the contract nephrologist shall be contacted for orders to provide appropriate patient care.

F. The contractor may not monitor access through noninvasive vascular studies such as duplex and Doppler flow scans and bill separately for these procedures. Noninvasive vascular studies are not covered as a separately billable service if used to monitor a patient’s vascular access site. The technical component of the procedure is covered in the Price per treatment.

G. The contractor is required to provide documentation on the hemodialysis flow sheet and add via CPRS for all treatment/services provided on…

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