R--Tumor Registry Services

DESCRIPTION: the VA Nebraska Western Iowa Health Care System intends to negotiate a commercial (FAR Part 12) sole source contract for with Grace Registry Services, 16921 135th Place SE, Renton, WA 98058, under the authority of FAR 6.302-1. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) FAC 2005-24. Only one responsible source and no other supplies or services will satisfy current agency requirements. A justification for other than full and open competition is being prepared in support of this acquisition. The selected vendor is required to start work on this contract on Friday, April 30, 2011. Statement of Work The Department of Veterans Affairs, Nebraska Western Iowa Healthcare System (VA NWIHCS), located at 4101 Woolworth Avenue, Omaha, NE, has a requirement for Tumor Registry Services. Contract shall be for a one year period with one one-year option. This requirement consists of seven (7) line items: ITEM DESCRIPTION EST. QTY UNIT OF MEASURE 0001 Abstracts 450 EA 0002 Case Finding Cases 3,400 EA 0003 Follow-ups (1200 annually; add'l 600 for the base year to get caught up) 1,800 EA 0004 Consult Hours 60 HR 0005 Reject Processing 12 EA IF REQUIRED 0006 On-Site Consult Hours - Visits for Survey Readiness 40 HR 0007 Travel Expenses - contractor to submit actual receipts 1 LS Cancer registration is the fundamental method by which information is systematically collected about the occurrence of cancer (casefinding), the types of cancer that occur (site, morphology, behavior), extent of disease at the time of diagnosis (stage), the kinds of treatment received by cancer patients, and the outcomes of treatment (survival). Qualifications: Contractor shall be registered with the American College of Surgeons Commission on Cancer as a trained Tumor Register and shall be verified on the Commission for Cancer website. The Contractor responsibilities shall include: (a) Records maintenance, including completion of abstraction. (b) Case abstracting and coding. (c) Computer data entry (electronic patient record/VISTA Oncology package) of all cases. (d) Meeting reporting requirements of statewide cancer registry, the American College of Surgeon's Commission on Cancer and the VA Central Cancer Registry. (e) Maintaining credentials through the National Cancer Registrar's Association. (f) Maintaining a cancer database that can be used to evaluate the efficiency of cancer therapy in the region as well as provide a base for epidemiological studies; and (g) Maintaining patient and records confidentiality in accordance with the Privacy Act of 1974, complying with the terms of VA computer access security agreement, and other applicable government regulations. (h) Providing occasional consultative services both by telephone and on site to assist VA NWIHCS in the accreditation process. Facilities This is a requirements contract for the following site: " Nebraska-Western Iowa Health Care System: 4101 Woolworth Ave., Omaha, NE Industry Standards Definition: Data definitions and coding rules must include those set by the following national and international standard setters to include: the American College of Surgeons' Commission on Cancer, National Cancer Institute's Surveillance, Epidemiology and End Results Program, North American Association of Central Cancer Registries, World Health Organization's International Classification of Diseases for Oncology, latest edition. Personnel Policy: The Contractor shall assume full responsibility for the protection of their personnel furnishing services under this contract, in accordance with the personnel policy of the contractor, such as providing workman's compensation, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that such personnel shall NOT be considered VA employees for any purpose and shall be considered employees of the Contractor except as provided under 5 U.S.C.A. 522a for purposes of prosecution of the Privacy Act. Confidentiality: The VA shall provide the Contractor will access to pertinent patient medical information for the purposes of providing tumor registry abstracting. The Contractor shall be subject to the provisions of 38 U.S.C.A. § 5701, § 5702 and § 7332, and the Health Insurance Portability and Accountability Act (HIPAA) as well as all other Federal Privacy and Record Keeping Laws and Regulations. In addition, the Contractor will be required to sign a Business Associate Agreement (BAA) for the purposes of compliance with the Privacy and Security Rules as described in the BAA (see Attachment B). The agreement is in accordance with Business Associate Protected Health Information (PHI) and Electronic Protected Health Information (EPHI) that is subject to protection under regulations issued by the Department of Health and Human Services, as mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Title 45 Code of Federal Regulations (CFR) Parts 160 and 164, Subparts A and E, the Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule"), and 45 CFR Parts 160 and 164, Subparts A and C. The Contractor is not authorized to release any medical record information. The VA is the sole entity authorized to release this information upon written request from the patient. Contractor Responsibilities (a) Contractor shall provide all necessary computer equipment for use at remote site. The VA does not intend for the contractor to work on-site. (b) Contractor shall initiate all applicable physician TNM staging templates at the time of case-finding (c) Contractor shall provide the Cancer Registry function of Follow-up as described in the Standards of the American College of Surgeon's Commission on Cancer (ACoS CoC); Facility Oncology Registry Data Standards (FORDS). These functions shall include computer input, data review and report generation tailored to the needs of the VA. (d) Contractor personnel functioning under this contract shall be Certified Tumor Registrars, certified by the National Cancer Registrars Association. Contractor shall verify its personnel current certification status with the National Cancer Registrars Association and shall provide evidence of certification along with their proposal. (e) Contractor's abstracting personnel may perform the abstracting functions from remote locations by computer modem and shall comply with the industry standard of case completion of six (6) months after date of diagnosis. A list of cases completed shall be provided to the Contracting Officer's Technical Representative (COTR) along with monthly invoices, abstracting shall encompass the full and complete data set (required, optional and supplemental fields) to present a complete patient summary in the VISTA Oncology package; text field shall be utilized to document finds on Physical Exam, Scans, Scopes, Labs, Diagnostic OPS and Pathology, Collaborative Stage and AJCC TNM staging shall be performed on all cases meeting the criteria as established by SEER and the American Joint commission on Cancer, 6th Manual for the Staging of Cancer, in conjunction with accepted principles. (f) Contractor shall provide follow-up of living cancer patients in compliance with accepted industry standards, posting information on recurrence, subsequent therapy, date of last contact, vital status, cancer status, any comments supporting the findings. Outcome data shall be included when applicable. Follow-up shall be maintained at a minimum of 90% on all patients in the registry data base, this is required to use registry data for survival (outcome) analysis, which is industry standard. Cases are delinquent (lost) if the follow-up interval exceeds 15 months. Contractor shall provide a list of patients completed follow-up along with monthly invoice. (g) Contractor shall perform a random 10% quality assurance on all newly abstracted cases for compliance noting any deficiencies or non-deficiencies. A list shall be forwarded to the COTR via e-mail noting any deficiencies or non-deficiencies at that time. VA NWIHCS Cancer Committee will provide a quality review of this data. (h) Contractor shall correct all inconsistencies found through any quality assurance review within 2 months of submission of inconsistencies, errors, warnings, or any other data quality problems at no additional cost to the VA. (i) Contractor shall comply with all guidelines governing the accepted standard of registry operations, to include the American College of Surgeon's commission on Cancer American Joint commission on Cancer, National Cancer Institute's Surveillance, Epidemiology and End Results Program, North American Association of Central Cancer Registries, World Health Organization's International Classification of Diseases for Oncology, 3rd Edition, both current and future. (j) Contractor's employees shall sign VA's Confidentially Disclosure Agreements and forms as required. VA Responsibilities: Contractor's employees shall sign VA's Confidentially Disclosure Agreements and forms as required. VA will provide computer access to the electronic medical records and programs maintained in the VA data system. IDCU passwords and a toll free number for remote location abstractors will be provided. VA will perform periodic updates, as deemed necessary to maintain currency on the use of the VA's software packages to include: Oncology Tumor Registry, Laboratory/Pathology, Surgery, Radiology, Discharge, Primary Care Patient Inquiry, Health Summary, VISTA Imaging, Show Progress Notes Across Patients and Electronic Mail. VA will perform unusual case finding; and patient care evaluation functions not contracted/negotiated previously, or for selected American College of Surgeons Electronic Patient Care Evaluations. VA will be responsible for annual reports, follow-up letters, contracts with physicians, family members, and any other health care provider pertaining to patients that may be lost to follow-up, case finding, data extraction for local VA needs, and reporting to all state and national agencies as required. VA Managing Physicians will be responsible for the staging of newly diagnosed cancer cases entering the appropriate stages into the appropriate staging templates initiated by Contractor at the time of case finding. The stages reported by the managing physicians will be posed to the appropriate cases in the fields Physician's State and Physician Staging when available. Quality Control The COTR will implement the plan to provide effective and systematic surveillance of all aspects of this contract. The COTR will monitor contract performance via audit of completed and in-process records. After contract award, any incidents of contract non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. VA COTR, along with Cancer Committee appointed representatives, will randomly select 10% of the total quarterly cases for quality assurance in regards to follow-up and abstracting. The quality surveillance plan will employ various monitoring methods including but not limited to the following: (a) Periodic Inspection. The Contractor's facility, methodologies, and quality control procedures may be examined by the COTR or designee at any time during the life of this contract. Examinations may be either scheduled or random findings documented by the COTR, or authorized designee, on the Surveillance Activity Checklist. (b) Random Basic Inspection, Contract requirements will be monitored on a random basis. The COTR, or authorized designee, will randomly visit areas to check for compliance with contract requirements. Findings will be recorded on the Surveillance Activity Checklist. Safeguarding VA Data In performing this contract, Contractor's employees, and Contractor's subcontractors (if any) shall maintain, access, release, and otherwise manage the information contained in the automated patient record system in accordance with all federal laws governing that information, including federal laws applicable to federal agency records. Contractor must take reasonable safeguards, both physical and electronic, to safeguard the information and prevent unauthorized disclosures in accordance with all HIPAA rules and regulations. Contractor, Contractor's employees, and Contractor's subcontractors (if any) shall follow all VA policies governing access to, release of, and management of the information maintained in the automated system. PRIVACY ACT REQUIREMENTS: Performance of contract services may involve review of VA patient records containing information subject to the Privacy Act, 5 U.S.C. Section 552a. The Contractor will perform in accordance with FAR clause 52.224-2, Privacy Act, Section I and provisions of Public Law 104-191 HIPAA. The Contractor shall maintain confidentiality of such information and shall be held liable in the event of a breach of confidentiality. Contractor shall take steps to ensure that it's employees and subcontractors (if any) are bound by this requirement and subject to adverse action, up to and including termination of the relationship with Contractor, for failure to follow these requirements and that its employees and subcontractors, if any, meet the same requirements as VA employees for access to information contained in the automated patient record system. Contractor shall utilize computers that are consistent with VA requirements and upgrade its computers if instructed to do so by VA in order to ensure compatibility with the VA system. In performing this contract, Contractor shall be considered a part of VA for purposes of 5 U.S.C. 552a, 37 U.S.C. 5701 and 7332. Contractor's employees and agent may have access to patient medical records to the extent necessary to perform this contract. Notwithstanding any other provision of this agreement, Contractor and/or its employees may not disclose information contained in patient records and or other individually identified patient information, including information and records generated by the Contractor in performance of this agreement, except pursuant to explicit instructions from the Department. For the purposes of this paragraph, instruction to disclose may be provided by VA Release of Information Officer. Records created by Contractor in the course of performing 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 policy. Access to data will be limited to the minimum necessary for performance of the contract. Contractor shall take steps to ensure that access is limited to those employees who need access to the data to perform the contract. Contractor shall not copy information contained in the system, either by printing to paper or by copying to another digital format, without the express permission of the VA Release of Information Officer, except as is necessary to make single copies in the ordinary course of providing patient care. Contractor shall not commingle the data from the system with information from other sources. Contractor shall report any unauthorized disclosure of VA information to the Release of Information Officer. If this contract is terminated for any reason, Contractor shall provide the VA with all individually-identified VA patient treatment records of information in its possession, as well as any copies made within seven days of the termination of the contract. Certain information available from the database and other records created by the Contractor under this contract are medical quality assurance records protected by 38 U.S.C. 5705; its implementing regulations at 38 U.S.C. 17.500-511; VHA Directive 98-016, 4.b(1)(d), 4.6(2)(c) and 4.6(4). These records may be disclosed only as authorized by 38 U.S.C. 5705 and the VA regulations. Disclosure of these records in violation of 5705 is a criminal offense under 38 U.S.C. 5705(e). Contractor shall follow all VA policies regarding the retention of records. In the alternative, Contractor may deliver the records to VA for retention. Any changes in the law or regulations governing the information covered by this contract during the term of this contract shall be deemed to be incorporated into this contract. Contractor shall educate its employees and subcontractors, if any, of the requirements of this section and shall advise its employees and subcontractors, if any, of any changes as they occur. On Contractor's request, VA will provide trainers who can educate Contractor's employees and subcontractors, if any of their obligations under this section. Contractor shall make its internal policies and practices regarding the safeguarding of medical and/or electronic information available to federal agencies with enforcement authority over the maintenance of those records upon request. Contractor and all Contractor employees who have access to the VA computer system under this contract, shall comply with all VA mandatory training as it pertains to computer access/security throughout the course of this contract. Contractor Personnel Security Requirements: All Contractor employees who require access to the Department of Veterans Affair's computer system shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to the contract performance. Schedule Items Definition(s): Casefinding: This process incorporates screening patient records using a coding system and the electronic casefinding module which is embedded in the software system. Each chart is reviewed using current industry standards for casefinding searches such as the North American Association of Central Cancer Registry guidelines, Commission on Cancer guidelines and the National Cancer Institute standards. Once the case is screened and accepted into the database it is flagged as Suspense with the demographics and primary site coded. Casefinding must be completed within 4 months of diagnosis to meet the industry standards. Abstracting: Documented cancer case abstracts are completed on each cancer case by encompassing the full and complete data set required in addition to supplemental and optional fields. The patient's workup, diagnosis, staging, protocol, treatment and survival information are all coded and entered into the oncology software system. Text to validate the codes is required. The cases must successfully complete screening with several required data edit sets before being considered complete. Abstracting requires a highly technical set of skills and only Certified Tumor Registrars (CTR) may complete abstracts. Cancer case abstracts must be completed within 6 months of date of first contact /or date of diagnosis to be considered compliant with national standards. Follow-up: Annually all cancer cases must be checked for cancer status and survival. This information is recorded with the most current data available. The outcome data must include recurrence information, subsequent therapy, date of last contact, vital status and cancer status. Death information including autopsy and death certificate validation codes must be entered as part of the follow-up process. The requirement for coding follow-up data includes having current information on 80% of all patients since registry reference date and 90% of patients registered within the last five years. Consult Hours: This item would be charged when data is pulled for the Cancer Committee or Administration. This would also include various tasks related to assisting with data submission to the state of Nebraska and the National VA Central Office. It would also cover any assistance with Commission on Cancer of the American College of Surgeons survey preparation that may be needed. (On-site consult hours - fees would have to include travel with receipts.) Rejects: This is a minimal fee to cover costs of reviewing cases that turn out not to be reportable cases and therefore need to be deleted from the data base. North American Industry Classification System (NAICS) code is 518210 (size standard is $23 million) applies to this solicitation. If solicited, this procurement will be a 100% small business set-aside. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. All vendor responses received by 3 p.m. Central Time, Thursday, April 28, 2011, will be considered by the Government. A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries will only be accepted in writing by mail, or by facsimile to the Contracting Officer at +1 (555) 000-0000.