Description of Services.pdf

DRAFT

PERFORMANCE WORK STATEMENT

FOR

ELECTROPHYSIOLOGY INPATIENT AND OUTPATIENT SERVICES

1. GENERAL:

1.1. Services Provided: The Contractor shall provide Board Certified /Board Eligible Physician Services on site in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the VA Sierra Nevada Health Care System.

1.2. Place of Performance - Contractor shall furnish services at the VASNHCS 975 Kirman Ave, Reno, NV 89502.

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

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

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

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

1.4.3. VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards -https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9174

1.4.4. VHA Handbook 1100.20: Credentialing and Privileging -

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444

1.4.5. VHA Handbook 1907.01: Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.6. 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. ACGME: Accreditation Council for Graduate Medical Education

1.5.2. AICD: Automated Implantable Cardiac Defibrillators

1.5.3. CDC: Centers for Disease Control and Prevention

1.5.4. CEU: Certified Education Unit

1.5.5. CME: Continuing Medical Education

1.5.6. 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.

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9174 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5.7. 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.

1.5.8. COS: Chief of Staff

1.5.9. CPARS: Contractor Performance Assessment Reporting System

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

1.5.11. 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.

1.5.12. DEA: Drug Enforcement Agency

1.5.13. EP: Electrophysiology

1.5.14. FSMB: Federation of State Medical Boards

1.5.15. HHS: Department of Health and Human Services

1.5.16. HIPAA: Health Insurance Portability and Accountability Act

1.5.17. ISO: Information Security Officer

1.5.18. POP: Period of Performance

1.5.19. PPD: Purified Protein Derivative

1.5.20. PWS: Performance Work Statement

1.5.21. 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.

1.5.22. QA/QI: Quality Assurance/Quality Improvement

1.5.23. QM/PI: Quality Management/Performance Improvement

1.5.24. QASP: Quality Assurance Surveillance Plan

1.5.25. 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).

1.5.26. 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.

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

1.5.28. 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.

1.5.29. VETPro: a federal web-based credentialing program for healthcare providers.

1.5.30. 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 Sierra Nevada Health Care Systems 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 Contractor’s physician(s) shall be Board Certified /Board Eligible by the American Board of Internal Medicine in Clinical Cardiac Electrophysiology http://www.abim.org /, and be currently certified in Basic Life Support (BLS) Advanced Cardiac Life Support (ACLS) or equivalency. All continuing education courses required for maintaining certification must always kept up to date. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.3. Credentialing and Privileging – Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.20 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any Contractor’s physician(s) prior to obtaining approval by the VASNHCS 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 shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all Contractor’s physician(s) and 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 http://www.abim.org/ report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for Contractor’s physician(s).

2.1.6. Training (ACLS, BLS and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the Contractor’s physician(s) as required by the VA.

Training Frequency (once a year, etc.) Annual Hours Contractor Rules of Behavior Annually <1 hour VA Cyber Security Awareness and Rules of Behavior

Annually <1 hour

VA Privacy Annually <1 hour Prevention and Management of Disruptive Behavior, Levels I, II, III

As assigned 4 hours

Universal Precautions and Blood Borne Pathogens

Annually <1 hour

TB Education Annually <1 hour Hazardous Material Management

Annually <1 hour

Life Safety Management (Fire Preparedness)

Annually <1 hour

Other trainings may be assigned when deemed appropriate through the length of this contract.

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 reaction to PPD testing for all Contractor’s physician(s). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

2.1.7.2. RUBELLA TESTING: Contractor shall provide proof of immunization for all contract physicians (s) for measles, mumps, rubella, or a rubella titer of 1.8 or greater.

If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.

2.1.7.3. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all Contractor’s physician(s); provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. 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.

http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

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:- Contractor shall provide copy of current DEA certificate.

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, because 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 1100.20. 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, http://oig.hhs.gov/exclusions/index.asp 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 Contractor’s physician(s). When a Contractor or Contractor’s physician(s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s 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 .20 FTE is defined by VA as a minimum of 16 hours every two weeks and does not include holidays.

2.9.2. The minimum number of Board Certified /Board Eligible Cardiac Electrophysiology Physicians required to be on site on Thursdays 1 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 VASNHCS 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 day (s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 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 workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.9.4.3. 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. HOURS OF OPERATION

3.1. VA Business Hours: Monday through Friday 0730-1600

Clinic OR Schedule: One Thursday of every month the contractor will be in the clinic for 8 hours a day from 0730-1630, or until all work is completed. One Thursday of the month is typically reserved for new procedures. The remaining Thursdays of the month the contractor will be at the clinic for 5 hours a day from 0730-1230, or until all work is completed. The 5 hour days are normally reserved for new follow-up clinics but procedures may be performed.

3.1.1. Patients must be seen by a Contractor’s physician(s) on-site at VASNHCS 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. Contractor’s physician(s) shall be available and present in clinic during normal VASNHCS clinic hours, VASNHCS which will be established, and may be revised, as deemed appropriate for patient care by the Chief of Staff. Currently, normal clinic hours will be on Thursdays.

3.1.3. Contractor’s will be paid a flat rate of 8 hours once a month, with a flat rate of 5 hours the other weeks of the month and shall be present at VASNHCS during the 8- and 5-hour shifts. Contractor’s will be paid hourly on anything above the weekly flat rate shifts. In the event a procedure is not completed during the schedule 5 hour shift the contractor will be paid at the agreed upon hourly rate. In the event a contractor works over 8 hours they will be paid at the agreed upon overtime rate.

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

• Juneteenth

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared by the President of the United States to be a national holiday.

3.3. Cancellations: Any procedure or clinic cancellations shall be completed at a minimum of 90 days in advance of the requested cancellation date and any patients scheduled shall be seen prior to the date of cancellation whenever possible.

3.3.1. Unless a state of emergency has been declared or clinics are otherwise cancelled by the VAMC, 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 Contractor’s physician(s)’ care shall cover the range of

Electrophysiology 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:

4.2.1. The American Board of Internal Medicine (ABIM):

https://www.abim.org/~/media/ABIM%20Public/Files/pdf/publications/certification-guides/policies-and-procedures.pdf

4.2.2. The American College of Cardiology (ACC): .

http://www.acc.org/guidelines#doctype=Guidelines

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

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

4.2.5. The requirements contained in this PWS

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contractor’s physician(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 http://www.jointcommission.org/standards_information/hap_requirements.aspx http://www.hpoe.org/resources?show=100&type=8

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 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: Contractor’s physician(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: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 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: 975 Kirman Avenue, Reno NV 89502 Robert Smith (001 VA Sierra Nevada Health Care System, 975 Kirman Avenue, Reno, NV, 89502, (775) 328-1245 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp 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 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 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

4.4. Direct Patient Care: 90% of the time involved in direct patient care. Contractor shall be responsible for

4.4.1. Scope of Care: The Contractor shall provide Board Certified or Board eligible staff in Internal Medicine and the subspecialty of cardiovascular disease and fellowship trained in cardiac electrophysiology to the VA Sierra Nevada Health Care System (VASNHCS), Reno, Nevada Services include a full range of electrophysiology services for both inpatient and outpatient care. Contractor shall provide comprehensive cardiac electrophysiology consultative care for our veteran population including evaluation and treatment of patients for potential arrhythmias, disorders of the cardiac conduction system, syncope, evaluation of patients for permanent cardiac pacemaker placement or revision, and need for, implantation and monitoring of automated implantable cardiac defibrillators (AICD).

Assignments can be changed based on the needs of Medical Service and/or at the discretion of the Service Chief.

4.4.2. Clinic Responsibilities: Contractor’s physician(s) shall be present and on time for scheduled procedures and clinic start times as documented by physical presence in the special procedures unit and specialty clinic at the scheduled start time.

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

4.4.4. Discharge education: Provide discharge education and follow up instructions that are coordinated with the next care setting for all emergency department patients.

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

4.4.5.1. Quality Improvement: 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.

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

4.4.5.3. 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: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this

Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.5.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints.

In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

4.5.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.5.4. Performance Standards:

4.5.4.1. Measure: Provider Quality Performance

Performance Requirement:

Standard: OPPE documentation for all (100%) staff providing services under the contract.

All staff (100%) meet Standards.

Acceptable Quality Level: 100% meet Standards Surveillance Method: Ongoing Provider Performance Evaluation (OPPE) data pertinent to care performed for each provider working under this contract. OPPE data will review the following elements:

A. Patient Care Performance B. Medical/Clinical knowledge C. Practiced Based Learning and Improvement D. Interpersonal and Communication Skills E. Professionalism F. System Based Practice Frequency: Annually

4.5.4.2. Measure: Qualifications of Key Personnel

Performance Requirement: All Contractor’s physician(s) shall be Board Certified /Board Eligible in accordance with ACC Standards.

Standard: All (100%) Contractor’s physician(s) are board certified.

Acceptable Quality Level: 100% Surveillance Method: Random Inspection of qualification documents Frequency: Quarterly

4.5.4.3. Measure: Scope of Practice/Privileging

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

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

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

Surveillance Method: Random Inspection of records.

4.5.4.4. Measure: Patient Access

Performance Requirement: The Contractor shall provide Contractor’s physician(s) in accordance with the operating hours and VA clinical schedule outlined in this PWS.

Standard: All (100%) Contractor’s physician(s) are on time and available to perform services.

Acceptable Quality Level: Contractor’s physician(s) are on-time and available to perform services 95% of the time Surveillance Method: Periodic Sampling of Time and Attendance Sheets Frequency: Monthly

4.5.4.5. Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report. All incidents reported immediately (within 24 hours.)

Standard: All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

Acceptable Quality Level: 100% of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

Surveillance Method: Direct Observation

4.5.4.6. Measure: Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

Standard: All (100%) licensing, registration(s) and certification(s) for Contractor’s physician(s) shall be provided as they are renewed. Licensing and registration information kept current.

Acceptable Quality Level: 100% licensing, registration(s) and certification(s) for Contractor’s physician(s) shall be provided as they are renewed. Licensing and registration information kept current.

Surveillance Method: Periodic Sampling and Random Sampling Frequency: Annually, to coincide with renewal dates of required documents

4.5.4.7. Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per VAMC policy Standard: All (100%) of required training is complete on time by Contractor’s physician(s) Acceptable Quality Level: 100% completions Surveillance Method: Periodic Sampling Frequency: Annually

4.5.4.8. Measure: Privacy, Confidentiality and HIPAA

Performance Requirement:

Standard: All (100%) Contractor’s physician(s) comply with all laws, regulations, policies, and procedures relating to Privacy, Confidentiality and HIPAA

Acceptable Quality Level: 100% compliance Surveillance Method: Periodic Sampling; Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Directive 6500.6.

4.5.5. Registration with Contractor Performance Assessment Reporting System

4.5.5.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

4.5.5.2. Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations).

Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ 207-438-1690.

4.5.5.3. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty

(60) days to submit any comments and re-assign the report to the CO.

4.5.5.4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

5. GOVERNMENT RESPONSIBILITIES

5.1. VA Support Personnel, Services or Equipment:

5.2. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: (enter contract administration if not already listed in another area- list the title (not name) and contact information for COR, Clinical point of contact, and any other relevant personnel involved).

5.2.1. CO RESPONSIBILITIES:

http://www.cpars.gov/

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

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

5.2.1.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA;

replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

5.2.2. COR Responsibilities:

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

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

5.2.2.3. The COR will maintain a record-keeping system of services by established in check-in procedure with the provider, via email, phone, etc., and maintain an electronic log of days/times the provider worked. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

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

5.2.2.5. All contract administration functions will be retained by the VA.

6. SPECIAL CONTRACT REQUIREMENTS

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

6.1.1. The following are brief descriptions of required documents that must be submitted by

Contractor: upon award; weekly; monthly; quarterly’; annually, etc. identified throughout the PWS and are provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

What Submit as noted Submit To

Quality Control Plan: Description and reporting reflecting the contractor’s plan for meeting of contract requirements and performance standards

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

Contracting Officer

Copy of Sub Contracting Plan (as required) Copy of Contractor Certification Statement if non-subcontracting possibilities exist.

Upon proposal and as updated Contracting Officer

Copies of any and all licenses, board certifications, NPI, to include primary source verification of all licensed and certified staff

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

Contracting Officer with proposal;

renewal submitted to

VETPRO

system.

Proof of Indemnification and Medical Liability Insurance

Upon proposal and upon renewals.

Contracting Officer

Certificates of Completion for Cyber Security and Patient Privacy Training Courses

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

Contracting Officer

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

COR

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

Upon proposal and as updated COR

6.2. Billing:

6.2.1. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

6.2.1.1. Name and Address of Contractor

6.2.1.2. Invoice Date and Invoice…