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VA Palo Alto Health Care System DIAGNOSTIC MAMMOGRAPHER/GENERAL RADIOGRAPHER MONTEREY CBOC Performance Work Statement June 29, 2018 GENERAL 1.1. SERVICES REQUIRED: The Department of Veterans Affairs (VA) Health Care System located in Monterey, California Requires approximately 1.0 FTE contractor staff that is board certified by the American Registry of Radiologic Technologist (ARRT-M) in Mammography and Radiography (ARRT-R). Services include the full range of diagnostic mammography imaging care for outpatient VA patients. 1.2. PERIOD OF PERFORMANCE: September 1, 2018 through August 31, 2019 or until the contract ceiling is met. 1.3. PLACE OF PERFORMANCE: VA Palo Alto Health Care System Radiology Service (114) Monterey Community Based Outpatient Clinic 201 9th Street, Marina, CA 93933 1.4. AUTHORITY: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority 1.3.1. POLICY/HANDBOOKS 1.3.1.1 VA Directive 1663: Health Care Resources Contracting – Buying ID=347 1.3.1.2 VA Handbook 1100-18 Reporting and responding to State Licensing Boards ID=1364 1.3.1.3 VHA Handbook 1100.19 Credentialing and Privileging ID=1806 1.4.1.6 Privacy Act of 1974 (5 U.S.C. a) as amended updates/Vol XVll 4/page2.htm 1.5. DEFINITIONS/ACRONYMS1.4.1ASRTAmerican Society of Radiologic Technologists1.4.2ARRTAmerican Registry of Radiologic Technologists1.4.3ARDMSAmerican Registry of Diagnostic Medical Sonographers1.4.4ACOAdministrative Contracting Officer1.4.5CDCCenters for Disease Control and Prevention1.4.6CEUContinuing Education Unit1.4.7CMEContinuing Medical Education1.4.8CMSCenters for Medicare and Medicaid Services1.4.9COContracting Officer1.4.10CORContracting Officer Representative1.4.11COSChief of Staff1.4.12CPARSContractor Performance Assessment Reporting System1.4.13CPRSComputerized Patient Recordkeeping System1.4.14FSMBFederation of State Medical Boards1.4.15HHSDepartment of Health and Human Services1.4.16HICPACHealthcare Infection Control Practices Advisory Committee – a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC and the Secretary of HHS regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.1.4.17HIPAAHealth Insurance Portability and Accountability Act1.4.18ISOInformation Security Officer1.4.19POPPeriod of Performance1.4.20PWSPerformance Work Statement1.4.21QASPQuality Assurance Surveillance Plan1.4.22QMPQuality Management Program1.4.23SPESenior Procurement Executive1.4.24TJCThe Joint Commission1.4.25VADepartment of Veterans Affairs1.4.26VAHCSVeterans Affairs Health Care System1.4.27VetProA Federal web based credentialing program for health care providers1.4.28VHAVeterans Health Administration2. QUALIFICATIONS: 2.1. Staff/Facility: The contractor will be responsible for ensuring that each Technologist providing services under this contract is fully trained and completely competent to perform the required services covered by this contract. a. Certification/Degrees High School Diploma Certificate of Completion of Radiologic Technologist training program accredited by an institution recognized by the Council for Higher Education Accreditation (CHEA), and the JCERT. b. Experience Required: A minimum of five consecutive years of proven clinical experience in Diagnostic mammography in a level 1 or 2 hospital setting Prior VA experience Prior Hologic mammographic system background d. Probationary Period requirement: The first four weeks are probationary. During this period, the Government may request removal from the contract. The probationary period will be used to assess skill level and experience necessary to meet the PWS guidelines. 2.1.1. License: Contractor personnel shall be licensed to practice Radiologic Technology in a state, territory, or commonwealth of the United States or the District of Columbia and while not required the Government prefers that Contractor personnel possess a current Radiologic Technologist license to practice in the State of California. 2.1.2. Board Certification/Eligibility: Contractor personnel performing under this contract shall meet or exceed recognized national standards established by The Joint Commission (TJC) and have completed training from an accredited institution, and shall have received a certificate of completion of training in Diagnostic Mammography and be board certified in Mammography by the American Registry of Radiologic Technologist (ARRT- M). 2.1.3. Credentialing and Privileging: Credentialing and privileging will be done in accordance with the provisions of VHA Handbook 1100.19. This VHA Handbook provides updated VHA procedures regarding credentialing and privileging, to include incorporating: VHA policy concerning VetPro; credentialing during activation of the facility Disaster Plan; clarifications for the Summary Suspension of Privileges process in order to ensure both patient safety and practitioner rights, the credentialing requirements for other providers. 2.1.3.1. Initial applications for clinical privileges and applications for renewal of privileges must be submitted to the COR and/or designee, upon notice of contract award. Prior to providing services at VAPAHCS, all contractor personnel must be verified by the COR as having been credentialed (this must be documented by the COR). Additionally, if requested, the contractor shall make all proposed personnel available for interview prior to commencement of work and during the work and during the credential verification process. 2.1.3.2. Should the personnel proposed by the Contractor to provide services under this contract be denied privileges, or should the privileges of Contractor personnel be suspended, terminated, or revoked, the contractor, as well as the employee(s) in question, shall be notified of the basis for such actions. 2.1.3.3. Privilege renewal shall be in accordance with TJC requirements. 2.1.3.4. Contractor personnel who provide services under this contract will be required to report specific patient outcome information to the Chief, Radiology Service and the COR. Quality improvement data provided by the contractor personnel and/or collected by the VAPAHCS will be used to analyze individual practice patterns. This data may be used by VAPAHCS when renewal of contract is required of contractor personnel. 2.1.3.5. Contractor personnel who were previously credentialed by VAPAHCS may be exempt from this contract requirement provided that they can provide documentation to support current and active privileges. 2.1.3.6. VAPAHCS reserves the right to refuse or dismiss contract personnel whose personal or professional conduct jeopardizes patient care or the regular and ordinary operation of the facility. Reasons for refusal or dismissal include, but are not limited to unsatisfactory performance prior to and/or during the term of the contract, failure to receive favorable adjudication during a VA background investigation, failure to satisfy the requirements of the contract, physical or verbal abuse to patients, staff, or visitors, intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, ethical misconduct, conduct resulting in formal complaints by patients or other staff members, and any other valid reason considered objectionable. 2.1.4. Technical Proficiency: Contractor 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 will provide documents as needed to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. 2.1.5. Continuing Education Unit (CEU) Requirements: Contractor will provide the COR copies of current CEUs as required or requested by the VAPAHCS. Contractors registered or certified by the American Registry of Radiologic Technologist (ARRT) shall continue to meet the minimum standards for CEU to remain current. 2.1.6. Training (BLS/VA Mandatory): Contractor shall meet all VAPAHCS educational requirements. All mandatory courses must be completed by the Contractor staff as required by the VA. 2.1.6.1. Complete annual mandatory training by using the mandatory packet, attending training in person, or by going-on-line to complete the training. Complete mandatory security training, sign computer security agreement, receive training on the mandatory privacy policy, and receive copy of the Privacy Directive, VA Directive 6504, Restrictions on Transmission, Transportation and use of, and access to VA Data Outside VA facilities. The compliance and Business Integrity Training & Education – Contract (Revenue Cycle) Employees include the following training: 2.1.6.2. Awareness Training: Contractor employees shall complete initial Compliance awareness training within 30 days of commencing work under this contract as well as complete annual compliance awareness refresher training. At a minimum, CBI awareness training will include the following topics: (a) the revenue cycle, (b) seven elements of an effective compliance program, (c) definition of high-risk areas, and (d) definition of any compliance concerns and how to address a compliance concern. This requirement can be fulfilled by completing the training module available via the following internet site: . Med. CBI.asp 2.1.6.3. Remedial Training: When notified, contract employees must complete remedial training and education to address any detected compliance exceptions. 2.1.6.4. Proof of Training: Contract employees are responsible for submitting proof of awareness and remedial training completed to the Contracting Officer’s Representative (COR) for this contract. The COR will retain proof of training in accordance with applicable Records Control Schedule. 2.1.6.5. Contractor must be certified in Basic Cardiac Life Support (BCLS). 2.1.7. Standard Personnel Testing (PPD, etc.) 2.1.7.1. In general, all contract personnel must comply with OSHA requirements for healthcare facilities. All contract personnel are required to have annual PPD/TB screenings, current immunizations, and record of having been offered Hepatitis B vaccine prior to commencement of work. 2.1.7.2. A record keeping system that confirms compliance these OSHA The Joint Commission (TJC), OSHA, and the Centers for Disease Control and prevention (CDC) requirements shall be established and maintained by the contractor. Such records will be made available to the COR or VA Contracting Officer upon request. 2.1.7.3. Health Tests- Contractor attests that assigned personnel have fulfilled all testing and screening requirements as described below prior to providing screening requirements as described below prior to providing services at first duty shift. Evaluations and tests shall be current within the past year. 2.1.7.4. Tuberculosis Testing- All Contractor personnel shall provide proof of a Negative reaction to purified protein derivative (PPD) testing. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. 2.1.7.5. Rubella Testing- All contractor personnel shall provide proof of immunization for measles, mumps, rubella, or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization must be administered with follow-up documentation to the COR. 2.1.7.6. Varicella (chicken pox) testing- Provide a history' of varicella or, if unknown, results of a varicella antibody test; and if non-immune, vaccination with varivax. 2.1.7.7. OSHA regulation concerning occupational exposure to blood-borne pathogens- The contractor shall provide a generic self-study training module to its personnel; provide Hepatitis B vaccination series at no cost to its personnel who elect to receive it; maintain and distribute an exposure determination and control plan to its personnel; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. 2.1.7.8. Contracted personnel shall receive training in universal precautions and blood borne pathogens, TB education, hazardous material management and life safety management (fire preparedness). Training will be provided prior to initial assignment, at annually thereafter and as needed. 2.1.7.9. VA will notify the contractor of any significant communicable disease exposures as appropriate. The contractor's occupational health provider shall adhere to current CDC/HICPAC Guideline for "infection control" in health care personnel (AJIC 2012; 26:289-354) for disease control. The contracting agency shall provide follow up documentation of employee's clearance to return to the workplace prior to their return. 2.1.8. National Provider Identification (NPI): Not applicable. 2.1.9. DEA: Not required for Contractor at VAPAHCS- Not applicable. 2.1.10. Conflict of Interest: The Contractor and all Contractor staff 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 if applicable. The Contractor shall also provide statements containing the same information for any identified consultants or sub-Contractors 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. 2.1.11. Citizenship Related Requirements: While performing services for the VA, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non?immigrant who is in violation of their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. The Contractor must return a signed certification at the time of proposal 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 the VA. 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 and is applicable to the entire POP. 2.1.12. Annual Office of Inspector General (OIG) Statement: 2.1.12.1. In accordance with HIPPA and the Balanced Budget Act (BBA} of 1997, the VA 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. 2.1.12.2 Therefore, all Contractors shall review the OIG List of Excluded Individuals Entities on the OIG web site at oig to ensure that proposed Contractors and/or firm(s} are not listed. Contractors 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 or entity 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 Contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries. 2.1.12.3 By submitting their proposal, the Contractor certifies that the OIG List of Excluded lndividuals Entities has been reviewed and that the Contractors are and/or firm is not listed at the time of quote submission. 2.2. TECHNICAL DIRECTION: The qualifications of Contractor personnel are subject to review by the Chief Radiology Administrator and approval by the Chief of Radiology or his/her designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request during the administration of the resultant contract. 2.3. NON PERSONAL SERVICES: The parties agree that The Contractor, all Contractor staff, agents and sub-Contractors shall not be considered VA employees for any purpose. 2.3.1. Government Inherent Functions: Contractor and Contractor staff 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, 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, 2.3.2. No Employee status: The Contractor shall be responsible for protecting the Contractor's staff 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: ? Worker's compensation ? Professional liability insurance ? Health examinations ? Income tax withholding, and ? Social Security payments. 2.3.3. TORT: The Federal Tort Claims Act does not cover Contractors or Contractor's staff. When a Contractor or a member of their staff has been identified as a provider in a tort claim, The Contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor's (or Contractor's) staff action or non-action is the responsibility of The Contractor and/or insurance carrier. 2.4KEY PERSONNEL AND EMERGENCY SUBSTITUTIONS: The Contractor shall assign to this contract the following key personnel: all personnel working on this contract must have Contracting Officer (CO) approval once a clearance submittal by a contract employee has been successfully accepted by and access granted by the (CO). 2.4.1. During the first ninety (90) 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 Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions. 2.4.2. 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 Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer Representative will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contractor shall find acceptable replacements with 15 business days of a vacancy and/or when additional staffing is requested. 2.4.3. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person, any period exceeding two weeks will require the procedure as stated above, (Note: See clause VAAR 852.237-7, Indemnification and Medical Liability Insurance (JAN 2008)) 2.4.4. The parties agree that the contractor, its employees, agents, and Subcontractors shall not be considered VA employees for any purpose. 2.4.5. The VA will render emergency health services for an incapacitating injury or otherwise serious illness occuring while on duty. All services, to include wages earned during the period of initial medical evaluation provided by the VA, shall be reimbursed by the contractor. The contractor shall furnish the VA with the necessary injury/illness form(s) for reporting purposes. The VA for statistical and/or billing purposes will retain a copy of the completed form(s). 2.4.6. Contract costs is expected to include salaries, fringe benefits, vacation pay, holiday pay, academic support allowance and malpractice expenses. The government will reimburse the contractor for actual terminal vacation (accumulated annual leave) benefits paid to key personnel in the event they leave the contractors employment prior to the end of any contract period listed herein. However, the contractor is required to provide the services as required herein, per the contract, with a qualified employee. The government reserves the right to reject any contractor personnel and refuse them permission to provide services. The government, at its option, can reduce the contract price in the event services are not provided per in accordance with the contract clauses available herein. 3. Hours of Operation: 3.1.Business Hours: Contractor shall provide Radiology Services during normal work hours: 8:00 a.m. to 4:30 p.m., Monday through Friday. Work hours will normally, but may be changed depending on the needs of the service, lunch is a 30-minute break. Work hours may vary depending on clinical responsibilities. Contractor shall be responsible for payment of any leave, including sick leave, vacation time or holiday pay. 3.1.1. Work Schedule: Contractor personnel shall be available to furnish required services 5 days per week 52 weeks per year including local, state and Federal holidays. 3.1.2. Federal Holidays: Holidays are defined by OPM as follows: New Year’s Day, Martin Luther King's Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, and Christmas. 3.1.3. Cancellation Policy: Requirements for cancellation (if any). Unless a state of emergency has been declared or clinics and services are otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services. 3.1.3.1. If this contract is terminated for any reason, the Contractor will provide VA with all individually identifiable VA patient treatment records or other information in its possession, as well as any copies, within seven (7) calendar days of the termination of this contract. 4. CONTRACTOR RESPONSIBILITIES. 4.1 SERVICES REQUIRED: what specific imaging specialties are to be provided: Contractor provides the following specialize technologist: Mammographer Contractor personnel shall be by virtue of training and experience is able to perform all levels of mammographic imaging in his/her specialize radiology imaging areas. The Contractor personnel shall be under the direction of the Chief Radiology Technologist. 4.2 STANDARDS OF PRACTICE: Contractor shall be responsible for meeting or exceeding VA and The Joint Commission (or equivalent) standards. 4.2.1. Contractors care shall covers the range of services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care must be equal or exceed VA Standards. 4.2.2. Performance shall be according to the requirements contained in this PWS and equal to that of the Professional standards of the The Joint Commission (TJC). 4.2.3. Adhere to the ARRT Practice Guidelines and Technical Standards in the science of radiology to improve the quality of services to patients. Promote the safe and effective use of diagnostic radiology by describing Specific the safe and effective use of diagnostic radiology by describing specific training, skills, and techniques. ARRT Guidelines by specialty: Practice Guidelines describe recommended conduct in specific areas of clinical practice. They are based on analysis of current literature, expert opinion, open forum commentary and informal consensus. Guidelines are not intended to be legal standards of care or conduct and may be modified as determines by individual circumstances and available resources. . Radiology Modalities: ? Diagnostic mammographyGeneral radiography Organ specific and Subspecialty-specific Imaging of Adults: ? Breast Imaging 4.2.4. Contractor personnel shall perform services in accordance with ethical, professional, and technical standards of the healthcare industry consistent with VA policy, regulations, procedures, and protocol. Contractor personnel shall be technically proficient in the skills necessary to fulfill the requirements stated herein including the ability to understand, speak, read, and write the English language. 4.2.5. Must meet service staff criteria for initial appointment and reappraisal in accordance with VHA Handbook 1100.19, entitled Credentialing and Privileging to practice at VAPAHCS prior to beginning work. 4.2.6. Time and Attendance. Signing in and out through Vista emailing is a Requirement, and will be used to verify attendance for invoice payment. 4.3. RESIDENT TEACHING: Not applicable. Radiology residents teaching falls under the direction and supervision of the Chief of Radiology or his/her designee. 4.4 MEDICAL RECORDS 4.4.1. Authorities: Contractors 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 Record) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522z (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPPA). 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. Contractors 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. Contractors shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date. 4.4.1.1. By performing services under this contract, the Contractor is considered part of the VA healthcare activity for purposes of the following statutes and respective regulations implementing these statutes: Title 5 U.S.C Section 552a (Privacy Act), Title 38 U.S.C. Section 5701, Title 38 U.S.C. Section 5705, Title 38 U.S.C Section 7332, and Public Law 104-191 (HIPAA). Contract personnel shall have access to patient medical records and general files only to the extent necessary to perform their contractual duties. Contract personnel shall only release medical information obtained during the course of this contract to those VA medical staff members involved in the necessary care and treatment of the individual patient in which the information pertains. Notwithstanding any other clause and/or provision of this contract, if a request for release or disclosure of information is not necessary for the care and treatment of an individual patient, the contractor and the contract personnel shall not disclose any information contained in general files, patient records, and/or any other individually identifiable health information, including information and records generated by the Contractor in performance of this contract, except pursuant to explicit instruction and written approval from VA. For the purposes of this paragraph, instruction to disclose or copy such records and/or information may only be provided by the following: VA Regional Counsel and Chief, Health Information Management Service/Privacy Officer through the VA Contracting Officer. Violation of the aforementioned statutes may result in criminal and/or civil penalties. 4.4.1.2. Contract personnel who obtain access to hardware or media which may manipulate or store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for or infection with HIV, medical quality assurance records, or any other sensitive information protected under the statues and implementing regulations shall not have access to the records unless absolutely necessary to perform their contractual duties. Any contract person who has access to the previously mentioned data and/or information must not disclose it td anyone, including other contract personnel not involved in the performance of the particular contractual duty for which access to this data and/or information was obtained. 4.4.1.3. Information or records accessed and/or created by the Contractor in the course of performing services under this contract are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal law, regulations, and/or VA/VHA policy. The Contractor will not copy information contained in VA information systems, either by printing to paper or by copying to another digital format, without the explicit instruction and written approval from of the officials except as is necessary to make single copies in the ordinary course of providing patient care. The Contractor will not commingle the data from VA information systems with information from other sources. Contractor shall report any unauthorized disclosure of VA information to the officials. 4.4.1.4. The Contractor shall follow all VA policies regarding the retention of records. 4.4.1.5. The Contractor shall follow all of the previously mentioned statues and respective regulations implementing these statutes as well as VHA Handbook 1605.1 - Privacy and Release of Information and any other VA/VHA policies and procedures governing the information discussed in This section of the contract. Copies of the information discussed in the aforementioned paragraphs may be viewed by contract personnel in the Office of Health Information Management (see the Privacy Officer). All contract personnel with access to any of the previously mentioned records (electronic or paper) will be required to complete VHA Privacy Policy Training before accessing such record systems. This training must also be completed annually. The COR will be responsible for ensuring and documenting that this requirement is satisfied. 4.4.1.6. Any changes in the law, regulations, or VA/VHA policies or procedures governing the information covered by this section of the contract during the term of this contract, shall be deemed to be incorporated into this contract. 4.4.1.7. VA has unrestricted access to the records generated by the contractor pursuant to this contract. 4.4.2. HIPPA: Under HIPAA Privacy and Security Rules, the Contractor providing services under this contract is considered to be a "covered entity," and thus is not required to enter into a Business Associate Agreement with VA. However, the Contractor must observe Public Law 104-191 and all respective regulations implementing this law while providing services under this contract. 4.4.2.1. Access to and Safeguard of VA Information/Computer Systems: VA may provide contract personnel via personalized VA access codes. These access codes are confidential and are to be protected by the end user. Sharing of these access codes or misuse of VA information/computer systems is a Federal crime and may result in criminal penalties. When contract personnel no longer provides services to VA under the contract or no longer needs access to VA information systems, the Contractor shall immediately inform the COR so that the appropriate contract person's access codes can be deactivated. The COR will be responsible for ensuring that such access codes are deactivated. 4.4.2.2. All contract personnel accessing VISTA, or any other VA information/ computer system, will be required to complete VA Information Security Awareness Training and VHA Privacy Policy Training annually and sign all applicable computer user agreements prior to accessing VA systems. The COR will be responsible for ensuring and documenting that this Requirement is satisfied. Contract personnel shall maintain, access, release, and otherwise manage the information contained on VA information/computer systems in accordance with all VA/VHA security policies, applicable VA confidentiality statutes (Title 38 U.S.C. Section 5701 and Title 38 U.S.C Section 7332) and the respective regulations implementing these statutes, and Federal statutes and/or regulations applicable to Federal agency records. Copies of this information discussed in the aforementioned paragraphs can be provided to the Contractor and contract personnel upon request. 4.4.2.3. Contract personnel with access to VA information/computer systems shall take reasonable safeguards, both physical and electronic, to safeguard the information and prevent unauthorized disclosures. Should contract personnel know, or suspect, that VA information/computer security was compromised or that VA information was, or could possibly be, disclosed to an unauthorized party, contract personnel must immediately report such knowledge or suspicion to the COR, who will then immediately notify the appropriate VA officials. 4.4.2.4. If contract personnel are authorized by VA to access information/ computer systems remotely via non-VA issued computers, the Contractor will ensure that such computers are consistent with VA requirements, and will upgrade those computers (hardware and/or software) if instructed to do so by VA in order to ensure compatibility and security when VA information/computer systems are accessed by the end user. Individually identifiable health information will not reside on the contractor's computer hard drives. After contract award, VA reserves the right to inspect the contractor's facilities, installations, operations, documentation, records, databases, and computers to ensure these requirements are met. 4.4.2.5. The Contractor shall make its internal policies and practices regarding the safeguarding of medical and/or electronic information available to VA, and any other Federal agencies with enforcement authority over the maintenance and safeguard of such records, upon request. 4.4.2.6. The Contractor shall follow all of the previously mentioned statutes and respective regulations implementing these statutes as well as VA Directive 6504- Restrictions on Transmission, Transportation and Use of, and Access to VA Data Outside a VA Facility, VA Directive 6601 - Removable Storage Media, and any other VA/VHA policies and procedures governing the information discussed in this section of the contract. Copies of the information discussed in the aforementioned paragraphs may be viewed by contract personnel in the Office of Information Security (see the Information Security Officer). 4.4.2.7. Any changes in the laws, regulations, or VANHA policies or procedures governing the information covered by this section of the contract, during the term of this contract, shall be deemed to be incorporated into this contract. 4.4.3. Disclosure: Contractor and Contractors may have access to patient medical records: However, Contractor and Contractors must obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA's records, at VA's place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1 Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor. 4.4.3.1. Professional standards for documenting care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guideline established by the VAPAHCS. 4.4.3.2. Medical record entries shall be legible and maintained in detail consistent with good medical and professional practices so as to facilitate internal and external peer reviews, medical audits and follow-up treatments. Copies of received medical information shall be authenticated (signed) copies. 4.4.3.3. The quality of medical practice shall meet or exceed reasonable standards of professional practice for the required services in health care as determined by the same authority that governs VAPAHCS medical professionals and will be audited by the Medical Center, Service Line or other processes established for that purpose.4.4.4. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow polices and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor and Contractors to release patient information, the Contractor and Contractors 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 and Contractors shall be responsible for locating and forwarding records not kept at their facility. The VA's Release of Information Section shall provide the contractor and Contractors with assistance in completing the 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 forward to the VA Privacy Officer at the following address: Ana Marie Vitente, RN Privacy Officer, Office of the Director Veterans Affairs Palo Alto Health Care System 3801 Miranda Avenue, Palo Alto, CA 94304 4.5. DIRECT PATIENT CARE: 95% of the time involved in direct patient care 4.5.1. Contractor shall be responsible for: 4.5.1.1. Perform all procedures in sub-specialized radiology area, including evaluation of indication, protocol, triaging, and previewing for exam quality at completion of exam. 4.5.1.2. The Diagnostic mammographer/ General radiographer is primarily concerned with (1) combined specialized knowledge of radiology equipment and human anatomy to provide quality diagnostic images for the radiologist to examine and (2) patient’s safety and comfort. 4.5.1.3. Advises radiologists or referring physician of significant abnormalities that would require their immediate attention and visualization while the patient is undergoing examination. 4.5.1.4. The incumbent provides patient care which is appropriate to the cognitive, emotional and chronological maturation needs of the adult and/or geriatric patient population. Positions patient within the examining unit, monitors the patient during all phases of the examination. 4.5.1.5. Incumbent performs mammography, breast localizations and necessary functions to consistently assist the VA Palo Alto Health Care System through the FDA and ACR for Annual accreditation in Mammography, in addition to performing General Radiology exams. Incumbent also performs general Radiography examinations and all other duties as assigned. 4.5.1.5. Maintains adequate supplies so that examinations are not delayed due to the lack of necessary equipment and supplies. 4.5.1.6. Technologist performs independently Screening, Diagnostic, Appropriate Supplemental Procedures and Breast Localization Mammography exams. Receives patients, explains method of procedure, positions patient and makes exposures necessary for the requested examination. 4.5.1.7. Explains examinations to be performed to the patients so that an understanding of the purpose of the study as well as any requirements of the patients are thoroughly understood. This is done so that an adequate Mammographic study may be obtained in an effort to get diagnostic examinations for the purpose of treatment and diagnosis of disorders. 4.5.1.8. Gathers related information such as patient electronic medical record, X-rays, etc., so that correlation of examinations to other studies may be made by the radiologist in diagnosis and recommendation of treatment for medical disorders. 4.5.1.9. Technologist meets the requirements set forth in 21 CFR 900.12(a) (2), maintenance of an Advanced Registry in Mammography, provided by the American Registry of Radiologic Technology, in order to perform mammographic evaluations. 4.5.1.10. Assists quality assurance technologists in performing quality assurance testing on the Mammographic unit using phantoms, test tools, test check lists, etc. for the purpose of assuring peak performance of the mammography equipment. Maintains records of the quality assurance testing so that easy reference is available should servicing be necessary: (weekly basis) 4.5.1.11. Performs or supervises routine housekeeping duties to assure that the mammography section area is clean and sanitary. This is done so that when sterile procedures are required in the ultrasound area, there is minimal possibility of cross contamination due to unsanitary conditions. 4.5.1.12. The technologist selects the most pertinent images and electronically transmits them through the hospital and radiology network to the PACS system for image viewing distribution and permanent archive in PACS and WEBPACS throughout radiology and the hospital. The mammographer will continually evaluate image quality on the computer viewing station. He/ She will determine if problems can be corrected independently or needs to be referred to the Biomedical Engineering personnel and/ or appropriate vendor for repair. 4.5.1.13. The contractor shall be aware of and practice the safety policies/procedures of the medical center, and participate in quality assurance activities as directed. 4.5.1.14. Shall schedule and coordinate patients for various Mammography procedures according to room and time availability. Maintains records of patients treated, examination performed and any medical notations. 4.5.1.15. Examination quality shall be of such that the physician will be able to evaluate and treat the patient’s condition without requiring repeat examinations. 4.5.1.16. All patient safety incidents must be reported within 24 hours using the electronic reporting system (ePERS). 4.5.1.17. Employees hired will wear a VAPAHCS identification badge on the front of their clothing, as is required of other employees working at the VAPAHCS. 4.5.1.18. Maintains current certifications for venipuncture, registry and continuing education credits necessary for the American Registry of Radiologic Technologists with advanced licensure in Mammography as a Radiologic Technologist (ARRT-M). 4.5.1.19. Employee shall sign in and out to the immediate supervisor via electronic messaging in Vista in accordance with the service’s Time and Attendance policy. 4.5.1.20. Technologist independently performs standard Mammographic examinations. Confers with radiologists to establish requirements of examinations and determines optional factors, etc. to satisfy additional requests to determine the diagnostic results. 4.5.1.21. Technologist performs quality control and data must be recorded, tracked, and maintained in appropriate fashion. Technologist then provides corrective actions and troubleshooting, and will then notify biomedical engineers, if further assistance is required. Technologist performs and maintains annual checklists of the following quality control areas and at the frequencies noted in 21 CFR 900.12(e):Breast phantoms testing and evaluationEquipment assessment (control panel, equipment locks, light field testing, cables, KVmAs indicators)Equipment Compression force testsSoftcopy Workstation evaluation/testingDetector calibration Detector artifact evaluationDigital phantom assessments (optical density assessments)Signal to noise and Contrast measurementsSoftcopy Workstation evaluation/testingCompression thickness indicator evaluation Equipment repairs and preventative maintenance 4.5.1.22. Technologist updates post reviews of the following information, by the Chief, Imaging Service and lead-interpreting physician: required patient care procedures and complaint processes, breast localization guidelines, patient history form and result letters, Infection Control Policy (specific to mammography per FDA), mammography personnel duties (per FDA), MSDS specific to mammography section (per FDA), cleaning product(s) documentation (per Hologic, Inc.), any documentation of serious blood/body fluid contact (per FDA), and on- going log of equipment repairs and preventative maintenance, consumer complaints, medical audit, medical report content, patients with breast implants, direct communication of results to patients. 4.5.1.23. Technologist performs quarterly reviews compiling multiple mammographic statistics for management reviews, Women’s Veterans Health Program and Breast Surgeons. Results are also facilitated to the lead-interpreting physician. 4.5.1.24. Technologist tracks results of mammography and/or pathology procedures on women performed off-site, and ensuring the data is captured and entered into an approved software; e.g., WHS, VistA and/or CPRS. 4.5.1.25. Not less than quarterly, technologist is to provide to the Medical Physicist, the QC and/or QA records need to be reviewed to ensure the continued existence, continuity, and completion meets subsequent inspection standards. 4.6 ADMINISTRATIVE: 5% of time not involved in direct patient care 4.6.1 Contractor staff will attend service staff meetings as required by the Chief Radiology Administrator. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement. 4.6.1.1. Contractor's staff will participate in service and medical center quality improvement programs and activities relating to Radiology Service as required by VA Chief of Service. 4.6.1.2. Maintain work area in a safe and orderly manner and perform other related activities and special assignments as required. 4.6.1.3. Participate on conferences and meetings with the Palo Alto Division staff. 4.6.1.5. Completion of required medical record documentation including the use of computerized patient record systems where applicable. 4.6.1.6. Patient safety incidents must be reported within 24 hours using Patient Safety Report (ePERS). 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. 4.7 PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT 4.7.1. Methods of Surveillance: Contractor shall comply with the required standards as outlined in the QASP. The QASP shall be attached to the resultant contract and shall define the methods and frequency or surveillance conducted. 4.7.2. Performance Standards: The QASP outlines required standards and will be a part of the resultant contract. 4.7.3. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS) 4.7.4. The Contractor shall perform services under this contract in accordance with the ethical, professional, and technical standards of the healthcare industry, and must meet, or exceed, the current quality assurance standards recognized by Joint Commission and mandated by VHA quality assurance policies and/or performance measures. A copy of these standards, policies, and performance measures may be viewed by contract personnel in the Chief Technologist’s office . 4.7.5. The Contractor will not participate in, nor be a party to, any activities which are in conflict with Federal and/or State guidelines. In the event the Contractor encounters said conflicting situations, the Contractor will notify the COR or the Contracting Officer to resolve such issues. The Contracting Officer will document and be responsible for resolution of any such situations. Neither the VA nor the Contractor will be responsible for any delays or failures to perform due to causes beyond each party's control. 4.7.6. In order to adequately protect VA patients, the Contractor shall not introduce new procedures or services without prior recommendation to, and approval from the Chief Technologist, Radiology Service. 4.7.7. All services provided under this contract will be subject to Quality Assurance and Utilization Review procedures of VAPAHCS. 4.7.8. Quality Improvement: Quarterly Quality Improvement meetings are held. This data will be evaluated by the technologist(s) working in the radiology area. Further, a Contract Performance Evaluation form will be completed at the end of each quarter of the performance period (base year and options) and a copy forwarded to the Contracting Officer. 4.7.9. The Government reserves the right to refuse acceptance of Contractors 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 conduct. The final arbiter on questions of acceptability is the CO. 4.7.10. The CO shall resolve complaints concerning Contractor and/or Contractors 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. 4.7.11. Quality Improvement: Contractor shall participate in Quality Improvement, and Performance Improvement activities with staff as required by Joint Commission (or equivalent), and directed by Chief, Radiology Service. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g. professional judgments, diagnostic for specific medical treatment), in accordance with Federal Acquisition Regulation (FAR) 37.401(b). Contract personnel shall be subject to Quality Management measures, such as patient’s appointment are scheduled within Seven working days, and average outpatient wait time for imaging exam within 30 days of the requestors desire date for the procedure. 5. GOVERNMENT RESPONSIBILITIES 5.1 OVERSIGHT OF SERVICE/PERFORMANCE MONITORING: Contract Administration: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: Medical Sharing Team I Department of Veterans Affairs Network Contracting Office 21 (NCO 21) 5342 Dudley Blvd, Bldg. 209 McClellan Park, CA 95652-2600 Chief Radiology Administrator Veterans Affairs Palo Alto Health Care System Radiology Service - Contracting Officer Representative 5.2 VA SUPPORT PERSONNEL: 5.2.1. CO Responsibilities: 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.5.2.2. 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.5.2.3. 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 the contract staff to be provided by the VA or the contract agency as indicated; replacement of the contract staff and/or renegotiation of the contract terms or termination of the contract. 5.2.4. COR Responsibilities: 5.2.4.1. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incident of Contractor or Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. 5.2.4.2. The COR will be responsible for monitoring the Contracts performance to ensure all specifications and requirement are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected. 5.2.4.3. The COR will maintain a record-keeping system of services of the technical Quality Control performance standards. The COR will Review this data monthly when invoices are received and certify all invoices for payment. Any evidence of the Contractor's or Contractor's staff non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. 5.2.4.4. The COR will review and certify monthly invoices for payment. If in the event that Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference. 5.2.4.5. All contract administration functions will be retained by the VA. 5.2.3. The government shall furnish equipment and supplies required for performance under this contract at the VAPAHCS. Contract personnel shall be responsible for requesting necessary supplies and be responsible for the routine maintenance of government furnished equipment. 6. SPECIAL CONTRACT REQUIREMENTS: 6.2.3. BILLING: 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 charge for services rendered by the Contractor, even if VA does not pay for those services. The provision shall survive the termination or ending of the contract. To the extent that the Veterans desire services which are not a VA benefit or covered under the terms of this contract, the Contractor must notify the Veterans that there will be a charge for such service and that the VA will not be responsible for payment. The Contractor shall not bill, charge 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. It shall be considered fraudulent for the Contractor to bill other third party insurance sources (including Medicare) for services rendered to Veterans enrollees under this contract. 6.2.4. 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: 6.2.4.1. Name and Address of Contractor 6.2.4.2. Invoice Date 6.2.4.3. Contract Number and Purchase/Task Order Number 6.2.4.4. Date of Service 6.2.4.5. Total price 6.2.5. Payment Remittance: Monthly billing will be sent to the following address: Department of Veterans Affairs Financial Services Center PO Box 149971 Austin, TX 78714-8971 Invoices can also be faxed to the Commercial Payment Section at (512) 460-5540. 6.3. CONTRACTOR SECURITY REQUIREMENTS (HANDBOOK 6500.6) 6.3.3. VA Information and Information System Security/Privacy Language: 6.3.3.1. All Contractor employees, who require access to VA computer system and will work more than six (6) months (180 days) under this contract, shall be the subject of a background investigation and must receive a favorable adjudication from the VA SIC. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for VA. 6.3.3.2. For those Contractor employees who will work less than six (6) months (180 days) under this contract, a background investigation is not required; however, such employees will be required to initiate a SAC for Fingerprint Only prior to providing services under this contract. 6.3.4. VA Information Custodial Language: Contractor personnel who previously received a favorable adjudication as a result of a Government background investigation may be exempt from this contract requirement provided that they can provide documentation to support the previous adjudication. Proof of previous adjudication must be submitted by the Contractor to VA SIC through the VA Contracting Officer. Proof of previous adjudication is subject to verification by the VA SIC. Some positions maybe subject to periodic re-investigation. 6.3.5. Security Incident Investigation: Employees hired will need to successful complete a background security investigation before being appointed into this position and will need to be fingerprinted per Federal requirements. 6.3.5.1. Employees hired will wear a VAPAHCS identification badge on the front of their clothing, as is required of other employees working at the VAPAHCS. 6.3.5.2. Position Sensitivity- The position sensitivity has been designated as: Low Risk 6.3.5.3. Background Investigation- The level of background investigation commensurate with the required level of access is: Low 6.3.6. Contractor Security Investigation Requirements: In order to conduct a background investigation the Contractor shall submit or have their contract personnel submit the following required forms to the COR. The COR will arrange a time for contract personnel to complete fingerprint verification. 6.3.6.1. Standard Form 85, Questionnaire for Non-Sensitive Positions 6.3.6.2. Form 306, Declaration for Federal Employment 6.3.6.3. VSC forms 1A, 2, and 3 6.3.6.4. Electronic Fingerprint Verification OR FD 258, U.S. Department of Justice Fingerprint Applicant Chart End of Statement ................
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