Performance Work Statement - DCVAMC.docx

Performance Work Statement for Therapeutic Apheresis Treatment Services

1. GENERAL:

1.1. Services Provided:

The Department of Veterans Affairs Medical Center in Washington DC (DC VAMC) seeks a company with prior government contract experience, for the services of the following: Therapeutic Apheresis Treatment for the period November 29, 2025 to November 28, 2026.

1.2. Place of Performance – Delivery location shall be specified per delivery/task order. The contractor shall provide services by delivering requested Therapeutic Apheresis Treatment items to designated Veteran’s home as authorized by Attending Physician or designee.

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 http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

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

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

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

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

1.4.7. - 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. ACEP: American College of Emergency Physicians

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. AOD: Admitting Officer of the Day

1.5.4. CDC: Centers for Disease Control and Prevention

1.5.5. CDR: Contract Discrepancy Report

1.5.6. CEU: Certified Education Unit

1.5.7. CME: Continuing Medical Education

1.5.8. CMS: Centers for Medicare and Medicaid Services

1.5.9. 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.

1.5.10. 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.

1.5.11. COS: Chief of Staff

1.5.12. CPARS: Contractor Performance Assessment Reporting System

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

1.5.14. 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.

1.5.15. DEA: Drug Enforcement Agency

1.5.16. FSMB: Federation of State Medical Boards

1.5.17. HHS: Department of Health and Human Services

1.5.18. HIPAA: Health Insurance Portability and Accountability Act

1.5.19. HR: Human Resources

1.5.20. ISO: Information Security Officer

1.5.21. MOD: Medical Officer of the Day

1.5.22. 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).

1.5.23. NPPES: National Plan and Provider Enumeration System

1.5.24. POP: Period of Performance

1.5.25. PPD: Purified Protein Derivative

1.5.26. PWS: Performance Work Statement

1.5.27. 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.

1.5.28. QA/QI: Quality Assurance/Quality Improvement

1.5.29. QM/PI: Quality Management/Performance Improvement

1.5.30. QASP: Quality Assurance Surveillance Plan

1.5.31. 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.

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

1.5.33. 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.

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

1.5.35. 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 Washington DC Veterans Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License – Is duly licensed and registered, in good standing under the laws in Maryland or District of Columbia to engage in the practice of medicine, with said license and registration having not been temporarily or permanently surrendered, suspended, revoked or restricted in any manner, and is, and shall continue to be, an active member in good standing of the Medical Staff of that Hospital with appropriate privileges in accordance with that Hospital’s bylaws, rules, regulations, procedures and policies.

2.1.2. Technical Proficiency - Contract technologist(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 contract physician(s) and contract 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.

2.1.3. 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. Contract technologist (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 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 contract physician(s).

2.1.4. Training (ACLS and BLS): Contractor shall maintain and meet all VA educational requirements and mandatory course requirements.

2.1.5. Standard Personnel Testing/Infection Control: Contractor shall provide statement that all required infection control testing is current and that the contractor is compliant with OSHA regulations concerning occupational exposure to blood borne pathogens. The Contractor shall also notify the VA of any significant communicable disease exposures and the VA will also notify the contractor of the same, 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. Tests shall be current within the past year.

2.1.6. Conflict of Interest: The Contractor and all contract technologist (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.

2.1.7. Citizenship related Requirements:

2.1.7.1. 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;

2.1.7.2. 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.

2.1.7.3. 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.

2.1.7.4. 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.

2.1.7.5. 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.

2.1.8. 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.

2.1.8.1. 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. Non Personal Healthcare Services: The parties agree that the Contractor and all contract technologist (s) shall not be considered VA employees for any purpose.

2.3. Inherent Government Functions: Contractor and Contract technologist (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.

2.4. No Employee status: The Contractor shall be responsible for protecting Contract technologist (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:

2.5.1. Workers’ compensation

2.5.2. Professional liability insurance

2.5.3. Health examinations

2.5.4. Income tax withholding, and

2.5.5. Social security payments.

2.5. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract technologist (s) When a Contractor or contract technologist (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.

2.6. 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.

3. HOURS OF OPERATION

3.1. Business Hours: The VADC operates 24/7 and services shall be available twenty-four (24) hours per day, 7 days per week, 52 weeks a year pursuant to notice and scheduling arrangements.

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 by the President of the United States to be a national holiday.

3.3. Continuity of services under contact:

3.3.1. Unless a state of emergency has been declared or services are otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services.

3.3.2. Contractor is responsible for providing qualified personnel to perform duties as required by the contract. The VA must be informed at least 48 hours in advance if there will be a significant change in contractor’s ability to perform to allow for planning of service coverage and workload distribution. Requirements as noted in attachment B will be provided to all VAMCs and maintained by the contractor.

3.3.3. The contractor shall maintain open and professional communication with members of the facility and VISN. The contractor shall provide up-to-date points of contact to facilitate communication on clinical, technical, and administrative issues. Contracting staff will be available by phone and pager 24/7

4. CONTRACTOR RESPONSIBILITIES

4.1. General Requirements

Pursuant to a written order from the Attending Physician and upon the consent from the patient or the patient’s legal representative, The contractor shall perform therapeutic apheresis services for Provider’s patients as described in this Agreement.

4.2. Specific Requirements:

4.2.1 THE CONTRACTOR Therapeutic Apheresis Services. Pursuant to a written order from the Attending Physician and upon consent from the patient or the patient’s legal representative, THE CONTRACTOR shall perform therapeutic apheresis services and Photopheresis treatment for Provider’s patients as described in this Agreement. During the performance of the therapeutic apheresis services, THE CONTRACTOR personnel will monitor the patient and report any progress and/or complications to the Attending Physician or the Provider's representative. Other than the apheresis services, under no circumstance shall THE CONTRACTOR perform patient care or treatment duties, which duties shall be the responsibility of the Provider and Attending Physician.

4.2.2 Technical Personnel and Equipment. THE CONTRACTOR shall use its own equipment, supplies and disposables to render therapeutic apheresis services. THE CONTRACTOR shall provide qualified and trained medical and technical support personnel necessary to operate the therapeutic apheresis equipment. THE CONTRACTOR shall be responsible for proper equipment maintenance. In the event that Provider requires THE CONTRACTOR to use Provider’s equipment (see “Operator Only” arrangement referenced below), supplies and disposables to render services under this Agreement, THE CONTRACTOR is not liable for any maintenance or loss that arises out of the use of such equipment, suppliers or disposables, except to the extent that such maintenance is required, or loss results due to THE CONTRACTOR’s misuse of the equipment, supplies or disposables. The Parties agree that the THE CONTRACTOR technical support personnel shall act under the direction of the THE CONTRACTOR Medical Director. The procedure will be performed in accordance with THE CONTRACTOR's policies and procedures and, if applicable, Provider's policies and procedures.

4.2.3 Medical Director. Provider and THE CONTRACTOR agree that the THE CONTRACTOR Medical Director shall provide consultation services upon the request of the Attending Physician, including: the clinical indications for the therapeutic apheresis procedure, appropriate replacement fluid selection and balance, and other aspects related to the therapeutic apheresis procedure. The THE CONTRACTOR Medical Director will consult with the Attending Physician, as needed, regarding complications and modification of treatment regimen.

4.2.4 Informed Consent. Provider and Attending Physician are responsible for obtaining and documenting informed consent from the patient or patient’s legally authorized representative and assuring that the risks and benefits of therapeutic apheresis services have been adequately explained to the patient. THE CONTRACTOR may also request informed consent documentation from the patient or patient’s legally authorized representative before performing the services.

4.2.5 General. In performing its services and obligations under this Agreement, THE CONTRACTOR represents and warrants that it shall: (a) render its services in an efficient, professional and high quality manner in accordance with industry standards; (b) perform necessary record keeping functions for the therapeutic apheresis services as the Provider and THE CONTRACTOR from time to time reasonably prescribe; (c) complete all forms or reports as reasonably requested by the Provider; (d) permit Provider and its representatives at all reasonable times to observe and review the services and equipment relating to therapeutic apheresis; (e) abide by all reasonable policies and procedures that Provider may from time to time request be followed in connection with the therapeutic apheresis services; and (f) comply with all applicable laws, rules, regulations, ordinances and orders.

4.2.6 Services shall be available twenty-four (24) hours per day, seven (7) days per week pursuant to notice and scheduling arrangements mutually acceptable to The contractor and the Hospital.

4.2.7 The contractor will provide appropriate staffing for the Services to be provided under this Agreement including, without limitation, clinically competent staff and appropriate management. Clinical personnel will maintain compliance with The contractor’s exposure control program and satisfactorily complete blood borne pathogen training. The contractor will provide Hospital with copies of licensure for employees if desired.

4.2.8 All individuals performing Services on behalf of The contractor shall be either (i) duly licensed and qualified nurses or (ii) qualified technicians trained in extracorporeal therapy including Therapeutic Apheresis and Photopheresis treatments. Contract nurses will be credentialed by the VA prior to the provision of patient care services.

4.2.9 Medical oversight of apheresis procedure will be provided by The contractor physician(s). Consultation is available as needed by Hospital Medical personnel.

4.2.10 The contractor will perform such administrative functions as are necessary and related to the provision of the Services at the Hospital, including but not limited to the scheduling of treatments and the oversight of The contractor staff.

4.2.11 The contractor reserves the right to make all decisions regarding its staff, including, but not limited to, hiring, retention and scheduling. However, with reasonable cause, a Hospital will have the right to request that designated The contractor staff not be scheduled to provide services to Hospital.

4.2.12 Except as necessary and related to the provision of the Services hereunder, The contractor and those individuals performing Services on its behalf shall not be responsible for providing any products or care to patients of Hospital, in any way undertake the practice of nursing, render medical opinions or in any way interact with patients.

4.2.13 The contractor will provide the disposable supplies used by The contractor in connection with its provision of the Services.

4.2.14 The contractor will conduct its own quality assurance (QA) and/or performance improvement (PI) programs and will agree to participate in any QA/PI program sponsored by the Hospital. It is further agreed that upon the request of the Hospital, The contractor will provide verification of such quality assurance activities, as requested from time to time.

4.2.15 The contractor will provide capital equipment (“Capital Equipment”) as reasonably determined by The contractor to be appropriate for The contractor’s performance of the Services. With regard to such Capital Equipment, the parties acknowledge that The contractor will be responsible for the maintenance and service of the Capital Equipment and such equipment will remain the sole and exclusive property of The contractor at all times.

4.2.16 The particular brand of products or equipment identified herein to be utilized by Contractor may be replaced with other products at Contractor’s sole discretion, provided such replacement products are of equivalent efficacy and quality.

4.3. SPECIFIC REQUIREMENTS:

4.3.1 Appropriate dress, lab coat and/or scrubs.

4.3.2 ID badge must be worn at all times while on station.

4.3.3 Maintains courteous customer service skills toward patients, visitor and staff.

4.3.4 Secures patient's confidence and cooperation

4.3.5 Operates ionizing and/or sealed source radiation equipment

4.3.6 Calculates and maintain records of therapeutic and cumulative doses

4.3.7 Receives patients by checking name, social security number or date of birth and explaining the procedures to be performed per the request and assessment.

4.3.8 Archiving and documentation of procedure and other pertinent information.

4.3.9 Image annotation, evaluation, labeling and image quality for optimal demonstration of anatomic region, pathology and exam completeness for timely interpretation.

4.3.10 Exam protocol, including patient positioning and image display.

4.3.11 Evaluation of requisition or medical record

4.3.12 Responsible for medical equipment attached to patients during the radiographic procedures.

4.3.13 Provide for patient safety, comfort, and modesty.

4.3.14 Practice standard precautions; assures the cleanliness of the room, and re-stocks supply cabinet at the end of the tour.

4.3.15 Use proper body mechanics and/or mechanical transfer devices when assisting patients.

4.3.16 Recognize need for prompt medical attention and administer emergency care.

4.3.17 Maintain confidentiality of patient's information.

4.3.18 Take appropriate precautions to minimize radiation exposure to patient and staff.

4.3.19 Check equipment for working conditions prior to patient's examination. Notifies the supervisor of any equipment problems.

4.3.20 Selects technical factors and appropriate protocols using established criteria.

5.1 GOVERNMENT RESPONSIBILITIES:

5.1 The Hospital will request The contractor to provide all of the Services that a Hospital or its Patients may require during the term of the Agreement, together with other related services and disposables supplies, mutually agreed upon in writing.

5.2 The Hospital will ensure and warrant that each physician who prescribes and directs Services during the term of this Agreement (i) is in good standing on Hospital’s Medical Staff and duly credentialed by that Hospital (“Approved Physician”), (ii) is duly licensed and registered, in good standing under the laws in Virginia, Maryland or District of Columbia to engage in the practice of medicine, with said license and registration having not been temporarily or permanently surrendered, suspended, revoked or restricted in any manner, and (iii) is, and shall continue to be, an active member in good standing of the Medical Staff of that Hospital with appropriate privileges in accordance with that Hospital’s bylaws, rules, regulations, procedures and policies.

5.3 The Hospital will provide to the individuals who perform the Services on behalf of The contractor with basic orientation to Hospital’s policies and procedures including, but not limited to:

5.3.1 Dress codes and identification badge requirements

5.3.2 Reporting of industrial injuries and illnesses

5.3.3 Emergencies (e.g., fire, natural disasters, cardiac/respiratory)

5.3.4 Computerized systems (if applicable)

5.3.5 Hazardous waste/materials handling or disposal.

5.4 The Hospital will provide adequate and safe space sufficient for (i) performance of the Services and (ii) the storage of equipment and supplies if applicable, used by The contractor to perform the Services.

5.5 The space used for performance of the Services shall be equipped with all utilities including, but not limited to, water, electricity, heating/air conditioning, emergency backup power in case of power outage and telephone lines for voice and data transmission. Further, this space shall have the same level of facilities support as all other areas of the Hospital (e.g., janitorial and maintenance services, communications support, emergency response system, etc.).

5.6 The space used by The contractor for storage shall be lockable.

5.7 The Hospital shall clean and maintain all such Hospital-provided space.

5.8 All physical restraints, chemical restraints, security personnel and other personnel and/or equipment which is necessary or appropriate to restrain abusive and/or noncompliant patients in order to protect the safety and welfare of The contractor staff and of other Hospital patients.

5.9 Transfusion products as required for patient care both on an emergent and non-emergent basis to include plasma and red cells.

5.10 Equipment and supplies necessary to perform temporary treatment access including, without limitation, femoral catheters, and jugular and subclavian catheters (as determined by Hospital designated surgeon).

5.11 Emergency support services including emergency facility personnel, equipment and supplies, with used supplies to be restocked by the Hospital.

5.12 Access to, or copies of, patient medical records for the continuation of patient care.

5.11 All equipment and supplies necessary for The contractor to comply with all Hospital policies and procedures with respect to the treatment of patients with active Tuberculosis or other infectious diseases in conjunction with the provision of Covered Services.

5.12 The Hospital shall, at all times during the term of the Agreement: (i) be licensed as an acute care hospital in the state in which it is located, (ii) be a participating provider in the Medicare program, and (iii) be solely responsible for its compliance with all licensure, regulatory, accreditation and reimbursement requirements.

5.13 The Hospital agrees and acknowledges that it shall have full medical responsibility for its Patients both in general during the provision of the Services and agrees to supervise and monitor its Patients accordingly.

5.14 The Hospital and The contractor agree that The contractor shall have no responsibility for the transportation of, or for arranging the transportation of patients to or from Hospital.

5.15 The Hospital shall ensure that an approved Physician will be consulted to examine each Patient and determine if that Patient is a candidate for the Services. If a Patient is a candidate, the Approved Physician will prescribe the appropriate treatment. The relevant Hospital shall provide and complete, or cause its approved Physicians to complete, a written order for the Services, shall cause its approved Physicians to sign any verbal order made by them to The contractor during the course of treatment, shall ensure that appropriate informed consent is documented for each Patient receiving the Services, if applicable, and shall make the foregoing documents available to The contractor immediately prior to the provision of Services. The Hospital shall also make available to The contractor documentation of applicable authorizations, Patient information, diagnostic test results and clinical diagnosis. If questions arise from the order for Services or from other documentation provided in accordance with this paragraph, the Services will be delayed until The contractor has the required information, and all relevant parties arrive at a mutual understanding with respect to the Services to the provided.

5.16 The Hospital shall bill Medicare, Medicaid and all other third-party payers for the Services in accordance with all applicable laws, rules and regulations, and will properly disclose the nature and manner of The contractor Services on cost reports or where otherwise required.

5.17 Standards of Care: The contractor’s care shall cover the range of Therapeutic Apheresis 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 current recognized national standards as established by:

5.17.1 VA Standards:

5.17.2 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

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

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

5.17.5 The requirements contained in this PWS

5.18 MEDICAL RECORDS

5.18.1 Authorities: Contractor 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).

5.18.2 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.

5.18.3 Disclosure: Contractor 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.

5.18.4 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.

5.18.5 All imaging exam interpretations shall either meet or exceed established standards of timeliness, accuracy, content, and signature. Only medical abbreviations from The Joint Commission’s National Patient Safety Goals, current edition, will be used for documentation of the patient health record. Those abbreviations not acceptable to conform with the JCAHO directives are included Attachment “Do Not Use List

5.18.6 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: patrick.mills1@va.gov

5.18.7 Direct Patient Care: Contractor shall be responsible for

5.6.7 1.1 Scope of Care: Contractor shall be responsible for providing therapeutic apheresis services for Provider’s patients as described in this Agreement. During the performance of the therapeutic apheresis services, The contractor personnel will monitor the patient and report any progress and/or complications to the Attending Physician or the Provider’s representative. The Contractor provided in satisfaction of this contract shall be required to perform their assigned duties with regards to all admitted patients regardless of underlying disease process or physical condition of such patients or beneficiaries.

5.18.7.1 QA/QI documentation: The contractor shall complete the appropriate QM/PI documentation pertaining to all procedures, complications, and outcome of examinations.

5.7 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI)

5.7.1 Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys. 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.

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

5.7.3 Registration with Contractor Performance Assessment Reporting System

5.7.3.1 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 $150,000 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.

5.7.3.2 Each Contractor whose contract award is estimated to exceed $150,000 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 @ DSN: 684-1690 or COMM: 207-438-1690.

5.7.3.3 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.

5.7.3.4 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.

6 ADDITIONAL GOVERNMENT RESPONSIBILITIES

6.1 VA Support Personnel, Services or Equipment

6.1.1 Each Hospital will request The contractor to provide all of the Services that a Hospital or its Patients may require during the term of this Agreement, together with other related services and disposables supplies, mutually agreed upon in writing.

6.2 Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: Edward V. Crews, Administrative Officer Cor Lev I, Edward.Crews@va.gov, (202)745- 8391. Clinical point of contact, and any other relevant personnel involved).

6.2.1 CO RESPONSIBILITIES:

6.2.1.1 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.

6.2.1.2 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.

6.2.1.3 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.

6.2.1.4 COR Responsibilities: or 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.

6.2.1.5 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.

6.2.1.6 The COR will maintain a record-keeping system of services by invoice(s). 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.

6.2.1.7 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.

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

7 SPECIAL CONTRACT REQUIREMENTS

7.1 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.

7.1.1 The following are brief descriptions of required documents that must be submitted by Contractor: upon award; weekly; monthly; quarterly’; annually, etc. identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

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

VA Directive 1663 Appendix B Other than Cost and Price Information Supporting Proposed Rate (required for Affiliate onsite hourly)

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

7.2 Billing:

7.2.1 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:

7.2.1.1 Name and Address of Contractor

7.2.1.2 Invoice Date and Invoice Number

7.2.1.3 Contract Number and Purchase/Task Order Number

7.2.1.4 Date of Service

7.2.1.5 Contract Technologist

7.2.1.6 Hourly Rate

7.2.1.7 Quantity of hours worked

7.2.1.8 Total price

7.2.2 Vendor Electronic Invoice Submission Methods

Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA- FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

7.3 Payment Adjustments:

7.3.1 Invoices will be prorated for partial days/hours worked. The contractor shall be paid only for actual work performed onsite. Adjustments will be made by the quarter hour. Contract providers shall be responsible for reporting time worked accurately. The Contract shall be paid for actual hours performed.

7.3.1.1 The contract shall be in accordance with actual performance.

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

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

7.4.2 The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract.