36C26323Q0304 0002.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 31

N/A

John Becker Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

Logan Gahring Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

To all Offerors/Bidders

36C26323Q0304

05-17-2023

X

X X

06/21/2023 at 12:00 PM CST

X -1-

The purpose of this amendment is to provide changes to the original Performance Work Statement and the Quality Assurance Surveillance Plan Attachment. Changes have been highlighted in attachments for reference.

The amendment also extends the offer period from 06/02/2023 to 06/21/2023 at 12:00PM CST

John Becker Contracting Officer

PERFORMANCE WORK STATEMENT

GENERAL:

1.1 Services Provided: The Contractor shall furnish all personnel (labor), hemodialysis/peritoneal dialysis supplies, and hemodialysis/peritoneal dialysis equipment to include:

Dialysis and water treatment systems to provide services necessary to perform onsite Hemodialysis/Peritoneal Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, VA Central Iowa Health Care System (VA-CIHCS), located at 3600 30th St, Des Moines, IA 50310 (hereinafter referred to as VA-CIHCS) including all veterans admitted to the inpatient beds of the Community Living Center (CLC).

Registered nurses (RN) assigned by the Contractor to perform services covered by the contract shall have an unrestricted license from State of Iowa. The services to be performed by the RN trained in hemodialysis/peritoneal will be performed in strict accordance with VA-CIHCS policies, procedures, and regulations of the VA-CIHCS. The contract RN’s and biomedical equipment repair technologists will be responsible for the provisions of the ordered services to include set-up and safety check of all equipment and water treatment systems, initiating, monitoring (for CCPD services monitoring is provided by VA staff), and terminating treatment, documenting of procedures and clean-up and storage of dialysis equipment and supplies. VA- CIHCS will provide (two) mutually agreed upon locked storage room for supplies and equipment and access to a water source, sink, and drain. VA-CIHCS will provide all personal protective equipment (PPE), respiratory protection PPE supplies for all contractor providers/RNs servicing this agreement to exercise appropriate infection control measures.

The Contractor may be required to wear a respirator when working with veterans with airborne infectious diseases, which includes but not limited to TB and COVID. The use of respirators, if applicable, will require the Contractor to meet the requirements of 29 CFR 1910.134, Respiratory Protection, this includes medically approved to wear a respirator, and fit tested/trained on a tight-fitting respirator or trained on a loose fitting PAPR. VA Central Iowa does not provide the medical certification or the fit test/training for respirators for contractors.

The Contractor’s RN care shall cover the range of Hemodialysis services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by American Society of Nephrology (ASN). http://www.asn-online.org/education/training/fellows/educational- resources.aspx#Guidelines

1.2 Place of Performance: Contractor shall furnish services at the VA-CIHCS, 3600 30th St, Des Moines, IA 50310 facility.

1.3 Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and FAR Part 13.

1.4 Policy/Handbooks:

http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines

1.4.1 VA Directive 1663: Health Care Resources Contracting - Buying VA Publications

1.4.2 VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) VA Publications

1.4.3. VHA Directive 2010-018 “Facility Infrastructure”

www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2227

1.4.4. VHA Directive 1192 “Seasonal Influenza Prevention Program https://www.publichealth.va.gov/docs/flu/VHA_Directive_1192_Sep

1.4.5. VHA Handbook 1100.17: National Practitioner Data Bank Reports http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.6. VHA Handbook 1100.18 Reporting and Responding To State Licensing Boards http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.7. VHA Handbook 1100.19 Credentialing and Privileging

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.8. VHA Handbook 1907.01 Health Information Management and Health Records http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

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

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5 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.

1.5.1. ANNA: American Nephrology Nurses Association https://annanurse.org/

1.5.2 ASN: American Society of Nephrology http://www.asn-

online.org/education/training/fellows/educational-resources.aspx#Guidelines

1.5.3. ASH: American Society of Nephrology

1.5.4. ACGME: Accreditation Council for Graduate Medical Education

1.5.5. ACLS: Advanced Cardiac Life Support

1.5.6. AOD: Admitting Officer of the Day

1.5.7. BLS: Basic Life Support

1.5.8. CCNE: Commission on Collegiate Nursing Education:

www.aacn.nche.edu/accreditation

1.5.9. CDC: Centers for Disease Control and Prevention

1.5.10. CDR: Contract Discrepancy Report

https://www.va.gov/vapubs/search_action.cfm?dType=1 https://www.va.gov/vapubs/search_action.cfm?dType=1 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2227 https://www.publichealth.va.gov/docs/flu/VHA_Directive_1192_Sep http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm https://annanurse.org/ http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines http://www.aacn.nche.edu/accreditation

1.5.11. CEU: Certified Education Unit

1.5.12. CME: Continuing Medical Education

1.5.13. CMS: Centers for Medicare and Medicaid Services

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

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

1.5.16. COS: Chief of Staff

1.5.17. CPARS: Contractor Performance Assessment Reporting System

1.5.18. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.5.19. 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.

1.5.20. DEA: Drug Enforcement Agency

1.5.21. ED: Emergency Department

1.5.22. FSMB: Federation of State Medical Boards

1.5.23. 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.

1.5.24. HHS: Department of Health and Human Services

1.5.25. HIPAA: Health Insurance Portability and Accountability Act

1.5.26. HR: Human Resources

1.5.27. ISO: Information Security Officer

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

1.5.29. Mission Act: Legislation to strengthen VA’s ability to deliver health care by consolidating VA community care programs into a single program that is much easier to navigate. Expands eligibility for Program of Comprehensive Assistance for Family Caregivers. Strengthening VA’s ability to recruit and retain the best medical providers and strengthening of VA’s infrastructure.

1.5.30. MOD: Medical Officer of the Day

1.5.31. 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).

1.5.32. NLNAC: National League for Nursing Accrediting Commission. NLN CNEA

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

1.5.34. NP: Nurse Practitioner

1.5.35. NPPES: National Plan and Provider Enumeration System

1.5.36. PA: Physician Assistant

1.5.37. PALS: Pediatric Advanced Life Support

1.5.38. POP: Period of Performance

1.5.39. PPD: Purified Protein Derivative

1.5.40. PPE: Personal Protective Equipment

1.5.41. PWS: Performance Work Statement

1.5.42. 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.

1.5.43. QA/QI: Quality Assurance/Quality Improvement

1.5.44. QM/PI: Quality Management/Performance Improvement

1.5.45. QASP: Quality Assurance Surveillance Plan

1.5.46. Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is in Washington, D.C.

https://cnea.nln.org/

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

1.5.48. 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.

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

1.5.50. Veterans Affairs Medical Center (VA-CIHCS): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the VA Central Iowa Health Care System (VA-CIHCS), Des Moines Division, located at 3600 30th St, Des Moines, IA 50310, Medical Center.

2. QUALIFICATIONS:

2.1. Staff / Facility

2.1.1. The Contractor’s RN(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice nursing in the State of Iowa when services are performed onsite on VA-CIHCS property.

Contractor’s RN(s) who have current, full and unrestricted licenses in State of Iowa, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

2.1.2. RN(s) trained in Hemodialysis shall be BLS certified. Documentation verifying current certification shall be provided by the Contractor to the VA-CIHCS COR on an annual basis for each year of contract performance.

2.1.3 The Contractor(s) shall assure professional competence of all personnel provided to the VA-CIHCS. Personnel assigned by the contract holder(s) to perform the services covered by this contract shall have knowledge of the following standards:

(A) American Nephrology Nurses Association

(B) Advancement of Medical Instrumentation

2.1.4. Credentialing and Privileging –Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 referenced above.

The Contractor is responsible to ensure that proposed RN(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract RN(s) prior to obtaining approval by the VA Central Iowa Health Care System (VA-CIHCS) Professional Standards Board, Medical Executive Board and Medical Center Director.

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

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

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

2.1.7. Training (BLS, CPRS 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 RN(s) as required by the VA.

Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training Frequency (once a year, etc.) Annual Hours

BLS Every two years 3 hours

Privacy and HIPAA Reporting Curriculum

Annually 1 hours

VA Privacy Annually 1 hours

VA All Employee Mandatory Training

Annually 0.5 hour

VA Staff Mandatory Training

Annually 8 hours first year, 2 hours subsequent years

VA Privacy and Information Awareness

Prevention of Workplace Harassment/No Fear

Annually

1 hour

CPRS Once upon starting 8 hours

VISTA Imaging Once upon starting 1.5 hours

Mission Act Training Once upon starting 1.0 hours

Respirator Fit Test/Training

Annually 1.0 hours

2.1.8. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for RNs and biomedical equipment repair technologists by the date contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.1.8.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative interferon-gamma release assays (IGRA) for all Contractor’s and RN(s) and biomedical equipment repair technologists {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.

2.1.8.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor RNs and biomedical equipment repair technologists {This is applicable to all health care workers}.

2.1.8.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor RNs and biomedical equipment repair technologists {This is applicable to all health care workers}.

2.1.8.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor RNs and biomedical equipment repair technologists {This is applicable to all health care workers}.

2.1.8.5. INFLUENZA: Contractors shall provide proof that all Contractor providers and RNs have received the annual Influenza vaccine unless it is contraindicated. If the Contractor RN or biomedical equipment repair technologist has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.8.6. 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 RN(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. VA-CIHCS will provide all personal protective equipment (PPE), and PPE supplies for all contractor providers, RNs or biomedical equipment technologists servicing this agreement to exercise appropriate infection control measures.

2.1.8.7. OSHA REGULATION CONCERNING RESPIRATORY

PROTECTION: Contractor shall provide evidence of completing respirator fit testing/training on the tight-fitting respirator or training for the loose-fitting respirator on any respirator used. VA-CIHCS will provide all personal protective equipment (PPE) and PPE supplies for all contractor providers, RNs or biomedical equipment technologists servicing this agreement to exercise appropriate infection control measures.

2.1.8.8. The VA-CIHCS 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. VA-CIHCS will provide all personal protective equipment (PPE) and PPE supplies for all contractor providers, RNs or biomedical equipment technologists servicing this agreement to exercise appropriate infection control measures.

2.1.8.9. COVID 19: Contractor shall provide proof of COVID 19 vaccination.

2.1.9. Conflict of Interest: The Contractor and all Contractor’s providers and RN(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 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf 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 (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.10. Citizenship related Requirements:

2.1.10.1. The Contractor certifies that the Contractor shall comply with 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.

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

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

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

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

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

2.1.11. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs.

Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.11.1. 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 RN(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 contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

2.2. 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. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VA-CIHCS COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.3. Non-Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s providers, RNs and or biomedical/hemodialysis technologists shall not be considered VA employees for any purpose.

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

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

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

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

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Income tax withholding, and

2.7.4. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor, contract provider(s) or contract RN(s). When a Contractor, contract RN or biomedical equipment repair technologist has been identified as a provider of service, RN, or biomedical equipment repair technologist 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 provider and RN(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) Nurse for the services required is less than 1.0 FTE as defined by VA. Full time equivalent (FTE) Nurse, 1.0, is defined by VA as a 2,080 hour per year, 80 hours every two weeks and does not include holidays.2.9.2. The Contractor shall be responsible for providing coverage to the VA-CIHCS 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 RN is unable to complete an assigned shift, the contractor shall provide replacement RN coverage within 2 hours and notify the Contracting Office Representative (COR) at the VA Central Iowa Health Care System (VA-CIHCS), Des Moines Division, located at 3600 30th St, Building 1, Room 2750, Des Moines, IA 50310 immediately of the schedule change.

2.9.3. 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 15 calendar days 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 15 calendar days prior to making any permanent substitutions. No services shall be provided by any contract RN prior to obtaining approval by the VA Central Iowa Health Care System (VACIHCS) Professional Standards Board, Medical Executive Board and Medical Center Director.

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

2.9.3.2. Contingency Plan: Because continuity of care is an essential part of VA-CIHCS’s medical services, The Contractor shall have a contingency plan in place to be utilized if the Contractor’s RN(s) or biomedical equipment repair technologist leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: VA-CIHCS inpatient services operate 24 hours a day, 7 days a week, 365 days a year to include national holidays. Administrative hours are Monday thru Friday 8:00 am to 4:30 pm.

3.1.1. Work Schedule:

(1) Workdays: The RN(s) trained in Hemodialysis/Peritoneal could be required to furnish services on all calendar days.

(2) Response times: Contract RNs will not be paid for on-call services or stand by pay in the performance of services for this contract. Acceptable response time is contingent upon the urgency of the need for hemodialysis services as determined by the ordering VA-CIHCS physician:

(A) Emergent Services/Immediate Services – within three (3) hours

(B) Chronic Routine – within twenty-four (24) hours

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

3.1.3. Patients receiving inpatient hemodialysis/peritoneal shall have it arranged by and will be performed by the Contractor’s RN. Contractor’s RN will be available during off-hours when the VA-CIHCS is open, closed, including evenings, weekends, and holidays. A hemodialysis/peritoneal treatment order from an authorized VA-CIHCS physician, with active VA-CIHCS medical staff privileges, must be present prior to commencement of hemodialysis services.

Patient treatment orders, assessment, and treatment plan will be documented and signed by authorized VA-CIHCS physician, with active VA-CIHCS medical staff privileges, within VA-CIHCS HIMS system per VA Handbook 1907.01.

3.1.4. Off-hours Coverage: Contractor must make the Contractor’s RN(s) and biomedical equipment repair technologists available all hours/all shifts, including evenings, weekends and holidays.

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

• New Year’s Day

• President’s Day

• Juneteenth

• Martin Luther King’s Birthday

• Memorial Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared to be a national holiday.

3.2.1. Unless a state of emergency has been declared, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. CLINICAL PERSONNEL REQUIRED: The Contractor shall provide RN(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Contractor’s RN(s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices. Time sheets are maintained in the hemodialysis equipment storage room located in both designated-on site storage closets.

4.2. Equipment and Supplies: The Contractor shall provide equipment and supplies necessary for hemodialysis. VA will provide dialysate for peritoneal dialysis. Ensuring supplies are adequately stocked and stored according to all VA guidelines and that equipment is in good working condition per this performance work statement.

4.3. STANDARDS OF CARE: The contract RN(s) care shall cover the range of Hemodialysis/Peritoneal services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized TJC, VA, VA-CIHCS and national standards as established by:

4.3.1. ANNA: American Nephrology Nurses Association https://annanurse.org/

4.3.2. American Society of Nephrology (ASN) http://www.asn-

online.org/education/training/fellows/educational-resources.aspx#Guidelines

4.3.3. VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

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

4.3.5. The standards of the American Hospital Association (AHA) American Hospital Association Homepage | AHA The requirements contained in this PWS

4.4. MEDICAL RECORDS

4.4.1. Authorities: Contractor’s RN(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.4.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA for Covered Entity to disclose Protected Health Information to: a health care provider or RN for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records- VA’ (24VA19). 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 are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at https://annanurse.org/ http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines http://www.asn-online.org/education/training/fellows/educational-resources.aspx#Guidelines https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 http://www.jointcommission.org/standards_information/standards.aspx https://www.aha.org/ https://www.aha.org/ http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www.rms.oit.va.gov/SOR_Records/24VA19.asp his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.4.3. Disclosure: Contract RN(s) may have access to patient medical records:

however, Biomedical equipment repair technologists will not have access to patient medical records. Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.4.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VA-CIHCS. All hemodialysis RNs providing hemodialysis care will document care in electronic patient records system, as well as Provider’s secured electronic medical records (ACES), before end of the day of service.

4.4.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address: Laurel Williamson, Privacy Officer VACIHCS 3600 30th Street, Des Moines IA 50310, Phone 515-699-5999 x4465.

4.5 DIRECT PATIENT CARE: estimated 90% of the time involved in direct patient care.

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791%20 http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf

4.5.1. Per the qualification section of this PWS, the Contractor shall provide the following staff:

4.5.1.1. Hemodialysis RN with six or more months direct clinical Hemodialysis experience.

4.5.2. Scope of Care: Contractor’s RN(s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Hemodialysis and Peritoneal Dialysis care, including, but not limited to:

4.5.2.1. Inpatient Care: Contractor’s RN(s) shall provide clinical Hemodialysis/Peritoneal Dialysis services

4.5.2.1.1. Contractor’s RN(s) shall provide comprehensive clinical Hemodialysis/Peritoneal Dialysis services. Typical procedures include, but are not limited to initiation, monitoring, and discontinuation of acute hemodialysis/peritoneal dialysis treatment. A hemodialysis/ peritoneal dialysis treatment order from an authorized VA-CIHCS physician, with active VA-CIHCS medical staff privileges, must be present prior to commencement of hemodialysis/peritoneal dialysis services. Patient treatment orders, assessment, and treatment plan will be documented and signed by authorized VA-CIHCS physician, with active VA-CIHCS medical staff privileges, within VA-CIHCS HIMS system per VA Handbook 1907.01. Supplies and maintenance of all dialysis machines, reverse osmosis units, and dialysis supplies and equipment needed for dialysis treatments to include CRRT and standard renal replacement therapies.

4.5.2.1.2. Set up, operation, cleaning, and disinfecting of dialysis machine and related dialysis equipment in accordance with Contractor’s policies and procedures, which shall meet AAMI standards at a minimum.

4.5.2.1.3. Attaching prescribed dialyzer and tubing to machine to assemble for use.

4.5.2.1.4. Mixing of dialysate, according to formula using aseptic techniques.

4.5.2.1.5. Priming dialyzer with saline or heparinized solution to prepare machine for use.

4.5.2.1.6. Calculation of fluid removal or replacement to be

achieved during dialysis procedure.

4.5.2.1.7. Inspection of equipment settings, including pressures, conductivity (proportion of chemicals to water), and temperature to ensure conformance to safety standards.

4.5.2.1.8. Initiation, termination, and monitoring of intradialytic treatments with Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG), and catheters.

4.5.2.1.9. Cleaning areas of access (fistula, graft, or catheter) and using antiseptic solution IAW MTF policies and procedures.

4.5.2.1.10. Connecting of hemodialysis machine to access in

patient's forearm or catheter site to start blood circulating through dialyzer.

4.5.2.1.11. Ensuring hemodialysis machine is working properly and that blood is moving through the tubing.

4.5.2.1.12. Inspection of venous and arterial pressures as

registered on equipment to ensure pressures are within established limits.

4.5.2.1.13. Monitoring of patient for adverse reaction and

hemodialysis machine and other dialysis equipment malfunction throughout dialysis treatment in its entirety.

4.5.2.1.14. Performance and documentation of patient’s pre-, interim, and post- dialysis treatment review of patient condition.

Recording of all treatment information. Documentation of other information related to the care of the patient in the individual patient electronic medical record system (CPRS).

4.5.2.1.15. Monitoring of patient status during dialysis treatment by assessing patient’s vital signs. Documentation of dialysis treatment parameters of dialysis flow with CPRS electronic medical records system used by the VA-CIHCS.

4.5.2.1.16. Reporting any significant changes in patient condition to the ordering physician, primary care team or their designee.

4.5.2.1.17. Checking blood chemistry deemed necessary to see if waste products are being removed via blood draws – pre- and post-dialysis treatment as ordered.

4.5.2.1.18. Labs will be prepared (if ordered by provider) by placing patient identification label and specimen in biohazard bag for transport/delivery to lab.

4.5.2.1.19. Disinfecting water system: monitoring water quality, collecting water and dialysate samples, conducting air quality testing, maintaining accurate records, and documentation and follow up on procedures related to ensuring water quality per clinic protocol. Records and documentation will be provided and maintained.

4.5.2.1.20. Cleaning and repair of equipment as needed and after each patient use.

4.5.2.1.21. RNs are responsible for reporting any significant information relating to change in patient’s condition or equipment problems to the ordering physician, primary care team or their designee.

4.5.2.1.22. Contractor personnel will ensure water quality control is maintained according to Association for the Advancement of Medical Instrumentation (AAMI) standards. This includes preventative maintenance according to manufacturer guidelines to include, but not limited to, periodic water sampling, and carbon and filter changes as manufacturer guidelines dictate. Duties may include:

4.5.2.1.22.1. Disinfecting/flushing of dialysis and reverse

osmosis machines.

4.5.2.1.22.2. Heat/Chemical disinfection of dialysis

machine.

4.5.2.1.22.3. Monthly water sampling according to

manufacturer guidelines.

4.5.2.1.22.4. Changing carbon tank quarterly and as

needed.

4.5.2.1.2. Posttreatment Follow-Up. Contractor RNs’ shall be conducted on post hemodialysis/peritoneal dialysis treatment patients in the Intensive Care Unit (ICU), patients in 3B, and on the inpatient bedded areas in the Community Living Center.