36C26320R0030-0003001.pdf

5. PROJECT NUMBER (if applicable)

CODE7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. 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 CODECODE

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 20

0003 01-30-2020

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Andrew J. Schoenecker 316 Robert Street N. STE. 506 St. Paul MN 55101

To all Offerors/Bidders 36C26320R0030

12-23-2019 X

X X

02-07-2020 4:30 PM CST

The purpose of this amendment is to extend the proposal due date to 02-07-2020 at 4:30 PM CST, and to revise the Peformance Work Statement (PWS) as shown in the following pages 2 - 20.

Andrew J. Schoenecker Contracting Officer

B.3 Performance Work Statement for Onsite Nephrology Services

1. GENERAL:

1.1. Services Provided: The Contractor shall furnish all personnel to provide services necessary to perform onsite Nephrology 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). The Contractor’s physician(s)’ and nurse practitioner(s)’ care shall cover the range of Nephrology 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 VAMC, 3600 30th St, Des Moines, IA 50310 facility.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and VAAR 873.

1.4. Policy/Handbooks:

1.4.1. VA Directive 1663: Health Care Resources Contracting - Buying https://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.2. 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

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

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

1.5.2. ASH: American Society of Nephrology

1.5.3. ACGME: Accreditation Council for Graduate Medical Education

1.5.4. ACLS: Advanced Cardiac Life Support

1.5.5. AOD: Admitting Officer of the Day

1.5.5.1 APC: Advanced Practice Clinicians. Interchangeably, the term Nurse Practitioner (NP) andor Physician Assistant (PA) may be used in this agreement. Formatted: Indent: Left: 0.45", First line: 0"

1.5.6. BLS: Basic Life Support

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

1.5.8. CDC: Centers for Disease Control and Prevention

1.5.9. CDR: Contract Discrepancy Report

1.5.10. CEU: Certified Education Unit

1.5.11. CME: Continuing Medical Education

1.5.12. CMS: Centers for Medicare and Medicaid Services

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

1.5.14. 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.

1.5.15. COS: Chief of Staff

1.5.16. CPARS: Contractor Performance Assessment Reporting System

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

VA.

1.5.18. 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.

1.5.19. DEA: Drug Enforcement Agency

1.5.20. ED: Emergency Department

1.5.21. FSMB: Federation of State Medical Boards

1.5.22. 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.

1.5.23. HHS: Department of Health and Human Services

1.5.24. HIPAA: Health Insurance Portability and Accountability Act

1.5.25. HR: Human Resources

1.5.26. ISO: Information Security Officer

1.5.27. 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.

1.5.28. 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.

1.5.29. MOD: Medical Officer of the Day

1.5.30. 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).

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

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

1.5.33. NP: Nurse Practitioner

1.5.34. NPPES: National Plan and Provider Enumeration System

1.5.35. PA: Physician Assistant

1.5.36. PALS: Pediatric Advanced Life Support

1.5.37. POP: Period of Performance

1.5.38. PPD: Purified Protein Derivative

1.5.39. PWS: Performance Work Statement

1.5.40. Privileging (Clinical Privileging): Privileging is the process by which a practitioner, licensed for

8independent 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.

1.5.41. QA/QI: Quality Assurance/Quality Improvement

1.5.42. QM/PI: Quality Management/Performance Improvement

1.5.43. QASP: Quality Assurance Surveillance Plan

1.5.44. 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.

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

1.5.46. 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.

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

1.5.48. 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 VA Central Iowa Health Care System (VACIHCS), Des Moines Division, located at 3600 30th St, Des Moines, IA 50310, Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. 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.

2.1.2. Board Certification: All contract Nephrology physician(s) shall be board certified/board eligible 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) or equivalency. All continuing education courses required for maintaining certification will be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.3. 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 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 VA Central Iowa Health Care System (VACIHCS) Professional Standards Board, Medical Executive Board, and Medical Center Director.

2.1.3.1. 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.

2.1.4. 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.

2.1.5. 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).

2.1.6. 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 physician(s) and nurse practitioner(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 FISMA Reporting Curriculum Annually 0.5 hour VA All Employee Mandatory Training

Annually 0.5 hour

VA Staff Mandatory Training Annually 0.5 hour VA Privacy and Information Awareness Prevention of Work Place Harassment/No Fear

Annually 1 hour

CPRS Once upon starting 4 hours

VISTA Imaging Once upon starting 1.5 hours

Mission Act Training Once upon starting 3.0 hours

2.1.7. 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.

2.1.7.1. 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.

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

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

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

2.1.7.5. 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}.

2.1.7.6. 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.

2.1.7.7. 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.

2.1.8. 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.

2.1.9. DEA and State Controlled Substance Certificate: Contractor shall provide copy of current DEA certificate and State of Iowa Controlled Substance Certificate (CSC).

2.1.10. 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 (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.11. Citizenship related Requirements:

2.1.11.1. 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;

2.1.11.2. 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.

2.1.11.3. 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.

2.1.11.4. 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.

2.1.11.5. 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.

2.1.12. 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.

2.1.12.1. 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.

2.1.12.2. 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 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.

2.3. 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.

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 physicians are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6. 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.

2.7. 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:

2.7.1.Workers’ compensation 2.7.2.Professional liability insurance 2.7.3.Health examinations 2.7.4.Income tax withholding, and 2.7.5.Social security payments.

2.8. 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.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) for the services required is 0.46 (resultant contract will provide approximately 960 hours per year coverage as identified in “Period of Performance” above, invoiced on actual services performed). Full time equivalent (FTE), 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 minimum number of board certified/board eligible Nephrology physician and experienced Nurse Practitioner / Physician Assistant (Nurse Practitioner and Physician Assistant can be is used interchangeably) providers required to be on-site on a daily basis, for days requested in B.2 Schedule of Services, is one Nephrology physician and one Nephrology Nurse Practitioner as defined in paragraph Hours of Operation in this section.

2.9.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled 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 VA Central Iowa Health Care System (VACIHCS), Des Moines Division, located at 3600 30th St (451), Bldg 1, Room 2750, Des Moines, IA 50310 immediately of the schedule change.

2.9.4. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within 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.

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

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

2.9.4.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s 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.

2.9.4.4. 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. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: Outpatient clinics 8:00 am to 4:00 pm weekdays Monday thru Friday. Inpatient new consults and Inpatient return visits on-call as required seven days a week.

Outpatient Clinic Services to be provided: a minimum of threetwo ½ day (4 hours) Nephrology (renal) clinics per week (52 weeks per year) and two Friday clinics per month.

(1) Clinic Schedule –

(a) Tuesday 12:00 pm – 4:00 pm Nurse Practitioner Weekly

(a)(b) Thursday 12:00 pm – 4:00pm Nurse Practitioner Weekly

(b)(c) Thursday 12:00 pm – 4:00pm Physician Weekly

(c)(d) Friday 8:00 am – 12:00pm Physician *

*First & Third Friday of the Month

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

3.1.2. Patients receiving inpatient peritoneal/hemodialysis shall have it orderedarranged by and will be followed by the Contractor’s employee. Contractor’s employee will be available on-call during all hours when the VAMC clinic is closed, including evenings, weekends, and holidays. Patient treatment orders, assessment, and treatment plan will be documented and signed within VAMC HIMS system per VA Handbook 1907.01.

3.1.3. Contractor’s physician(s) and nurse practitioner(s) shall be available and present in clinic during normal VAMC clinic hours, VAMC which will be established, and may be revised, as deemed appropriate for patient care by the Chief of Staff. Currently, normal clinic hours are 8:00 am to 4:00 pm weekdays, Monday thru Friday.

3.1.4. Off-hours Coverage: Contractor must make the Contractor’s physician(s) available on-call during all hours when the VAMC clinic is closed, including evenings, weekends and holidays.

3.1.4.1. On-call Contractor’s physician(s) must be available at all times for phone consultations with VA residents and physicians and call returned within 15 minutes.

3.1.4.2. Patients must be seen within 60 minutes of the page when medically indicated.

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

New Year’s Day President’s Day Martin Luther King’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Any day specifically declared to be a national holiday.

3.3. Cancellations: In the event of appointment cancellation, VAMC will be responsible for rescheduling patient’s appointment as per physician’s recommendation with procedures, other appointments or labs if possiblepossible, using protocol in VHA Directive 2010-027.

3.3.1. 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 contractor’s physician(s) who are competent, qualified per this performance work statement, and adequately trained to perform assigned duties.

4.1.1. Contractor’s physician(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.

4.2. Standards of Care: The contract physician(s)’ care shall cover the range of Nephrology 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 and national standards as established by:

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

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

4.2.2. 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

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

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

4.2.5. The requirements contained in this PWS.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contractor’s physician(s) and nurse practitioner(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).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. 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 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.

4.3.3. Disclosure: Contract provider(s) may have access to patient medical records, however, 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.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA 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 VAMC.

4.3.5. 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.

4.4. Direct Patient Care estimated 90 % of the time involved in direct patient care.

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

4.4.1.1. Board certified/board eligible Nephrologist.

4.4.1.2. Nephrology Nurse Practitioner (NP) / Physician Assistant (PA) with onefive or more years direct clinical nephrology experience.

4.4.2. Scope of Care: Contractor’s physician(s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Nephrology care, including, but not limited to:

4.4.2.1. Clinic and InpatientSurgical Care: Contractor’s physician(s) shall provide clinical and inpatient/on call Nephrology services.

4.4.2.1.4.4.2.2. Contractor’s physician(s) shall be present on time for any scheduled outpatient clinics as documented by physical presence in the clinic at the scheduled start time.

4.4.2.1.1.4.4.2.2.1. Contractor’s physician(s) shall provide comprehensive clinical Nephrology services for consultative clinical, inpatient, or on call services. Typical nephrology servicesprocedures include, but are not limited to: Consultation, evaluation and treatment of nephrology patients on an outpatient or inpatient basis, assessment of inpatients patients who may require peritoneal/hemodialysis treatment, dialysis iInitiation orders, monitoring, and discontinuation order of peritoneal/acute hemodialysis treatment or medication orders., supplies and maintenance of all dialysis machines, reverse osmosis units, and dialysis supplies needed for dialysis treatments to include CRRT and standard renal replacement therapies.

4.4.2.1.1.1. Set up, operation, cleaning, and disinfecting of dialysis machine and related dialysis equipment IAW MTF policies and procedures.

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

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

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

4.4.2.1.1.5.4.4.2.2.1.1. Calculation of fluid removal or replacement to be achieved during dialysis procedure.

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

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

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

4.4.2.1.1.9. Connecting of hemodialysis machine to access in patient's forearm or catheter site to start blood circulating through dialyzer.

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

4.4.2.1.1.11. Inspection of venous and arterial pressures as registered on equipment to ensure pressures are within established limits.

4.4.2.1.1.12. Monitoring of patient for adverse reaction and hemodialysis machine and other dialysis equipment malfunction throughout dialysis treatment in its entirety.

4.4.2.1.1.13.4.4.2.2.1.3. 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 record.

4.4.2.1.1.14. Monitoring of patient status during dialysis treatment by assessing patient’s vital signs. Documentation of dialysis treatment parameters on dialysis flow sheets used by the VAMC.

4.4.2.1.1.15. Reporting any significant changes in patient condition to the COR.

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

4.4.2.1.1.17. Preparation of lab specimens by placing patient identification label and specimen in biohazard bag for transport/delivery to lab.

4.4.2.1.1.18. 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.

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

4.4.2.1.1.20. Responsible for reporting any significant information relating to change in patient’s condition or equipment problems to the COR.

4.4.2.1.1.21. 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:

4.4.2.1.1.21.1. Disinfecting/flushing of dialysis and reverse osmosis machines.

4.4.2.1.1.21.2. Heat/Chemical disinfection of dialysis machine.

4.4.2.1.1.21.3. Monthly water sampling according to manufacturer guidelines.

4.4.2.1.1.21.4. Changing carbon tank quarterly and as needed.

4.4.2.1.2.4.4.2.2.2. Postoperative Follow-Up. Contractor Provider rounds shall be conducted on postoperative inpatients. in the Surgical Intensive Care Unit (SICU) and on the wards. All cases will be discussed in morbidity and mortality conferences, and the contractor physician (s) will provide appropriate information to the COR for inclusion in departmental reports, if requested.

4.4.2.1.3.4.4.2.2.3. Contractor’s physician(s)shall provide consultative services at the patient’s bedside if the patient is not ambulatory and in the clinic setting if the patient is able to report to the outpatient clinic. Procedures shall be scheduled for completion within 30 days of the date of the consult.

4.4.2.2.4.4.2.3. Medications: Contractor’s physician(s) shall follow all established medication policies and procedures. No sample medications shall be provided to patients.

4.4.2.3.4.4.2.4. Discharge education: Contractor’s physician(s) shall provide discharge education and follow up instructions that are coordinated with the next care setting for all Nephrology clinical patients.

4.4.3. ADMINISTRATIVE: estimated 10% of time not involved in direct patient care.

4.4.3.1. Quality Improvement Meetings: The Contractor’s physician(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

4.4.3.2. Staff Meetings: The Contractor’s physician(s) shall attend staff meetings as required by the VAMC Chief of Service, Chief of Staff, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement.

4.4.3.3. QA/QI documentation: The Contractor’s physician(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications, and outcome of examinations.

4.4.3.4. Patient Safety Compliance and Reporting: Contractor’s physician(s)shall follow all established patient safety and infection control standards of care. Contractor’s physician(s)shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

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

IMPROVEMENT (QI)

4.5.1. Quality Management/Quality Assurance Surveillance: Contractor’s physician(s)shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.5.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

4.5.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility.