R--520-17-1-040-0003, Tumor Registry Contract

STATEMENT OF WORK Contractor shall provide Abstracting Services to the Department of Veterans Affairs, Gulf Coast Veterans Health Care Systems, in accordance with the terms and conditions contained herein. A. Contractor Responsibilities: 1. Contractor shall be responsible for all abstracting services to include maintenance of a Tumor Registry within the framework of directives established for approval of Cancer Registries by the American College of Surgeons (ACOS) based on available data. Services shall include but will not be limited to the following: maintaining a repository of records and data related to the treatment; evaluation and study of cancer on a cumulative basis; identifying and abstracting relevant information; and analysis and correction of errors / edits on all patients treated at the VA with reportable neoplastic growths which require prolonged follow-up and observation. 2. Contractor shall maintain the confidentiality and security of patient data stored in the tumor registry computer database files. 3. Contractor shall maintain quality control of case finding, abstracting, edit review and coding of follow-up information and processing procedures to include ensuring that each follow up case contains the following at a minimum: a) Dates and types of treatment for persistent or recurrent disease, b) Site or sites of distant metastasis, c) Site and histology of subsequent primaries, d) Date of last contact, and e) Status of the patient and the cancer. 4. Other data requirements: a) Basal and squamous cell carcinomas of the skin that, at initial diagnosis have invaded regional tissue or nodes or have metastasized shall be included in the registry. b) Reportable cases shall include inpatient admissions and patients seen in ambulatory care, c) Localized basal and squamous cell carcinomas of the skin do not need to be included in the registry. 5. Contractor or its personnel shall provide Abstracting services, which shall include but not be limited to the following: a) Obtain core information from the patient's medical records including demographic characteristics, history of cancer, diagnostic procedures, diagnosis, and extent of disease and staging of treatment. b) Maintain data system and ensure that each electronic master patient index card contains core data in compliance with guidelines established by the American College of Surgeons (ACOS) Commission on Cancer. c) Prepare abstracts for analytical cases that meet the criteria for inclusion in the registry as outlined in the Cancer Program Manual published by the Commission on Cancer of the American College of Surgeons (ACOS). d) For patients who have multiple primary malignancies, an abstract shall be prepared for each reportable primary diagnosed or treated at the GCVHCS after the registry's reference date. Multiple primaries shall be cross-referenced. e) Route all cases through the Center for Disease Control, National Program for Cancer Registries, EDITS program. All identified errors will be corrected prior to completion of the abstract. 6. Contractor or its personnel shall have knowledge of the VA Computerized Patient Record System (CPRS), Veterans Health Information Systems and Technology Architecture (VistA), and the OncoTraX: Cancer Registry database. 7. VA will be responsible for arranging Contractor to obtain such access to patient health care records as is permitted by law and is necessary to provide the services. 8. Security Incident Investigations: a) The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access immediately or within 24 hrs Monday - Friday or the next business day if security incident happened over the weekend or federal holiday. b) To the extent known by the contractor/subcontractor, the contractor/subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c) With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d) In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 9. Liquidated Damages for Data Breach: a) Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any PHI the contractor/subcontractor processes or maintains under this contract. b) The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c) Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. B. Work Days/Hours: 1. Work days and hours shall be mutually agreed upon between the COR and the Contractor, excluding the following federal holidays: New Year's Day, Martin Luther King Jr. Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving Day, and Christmas Day, or any other day declared by the President of the United States to be a federal holiday. 2. Services may be provided after hours or on weekends, on such days and at such time as mutually agreed upon between the Contractor and the COR. C. Contractor Qualifications: 1. Personnel assigned by the Contractor to perform the services required under this contract shall be qualified as follows: a) Hold current certification as a Certified Tumor Registrar (CTR) from the National Cancer Registrars Association. A copy of such certification will be provided to the Contracting Officer prior to performance of work under the contract by any contractor and/or sub-contractor personnel. b) Have working knowledge of the International Classification of Diseases for Oncology (ICD-O), the guidelines required by the American College of Surgeons Commission on Cancer, and the Joint Commission. c) Have knowledge of the following: Natural history of cancers, including knowledge of cell types associated with various types of cancer and procedures for identifying neoplasms; anatomy and physiology as well as medical terminology, common acronyms and symbols; tumor nomenclature and classifications, ability to code topography, morphology and register tumor cases; descriptive statistics and end results reporting; and automated data processing techniques with ongoing or proposed computerized systems. 2. The CO and/or COR or designees specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to provide services under this contract. 3. Personnel assigned to provide services under this contract shall have a minimum of two (2) years' experience performing the specific services described herein, in a Tumor Registry. 4. Must complete Annual Training for Privacy and HIPAA (10203). D. Contract Monitoring: 1. The services provided under this contract will be monitored for quality, accuracy and technical acceptability by the Contracting Officer's Technical Representative (COR). 2. The Contractor's personnel shall be required to submit a record for each period of work performed under the contract. This record will be maintained by the COR, and verified against monthly invoices submitted by the Contractor. The Contractor should establish and maintain a separate record keeping system of hours worked for all its personnel providing services under the Contract. E. Quality Assurance and Contract Performance Monitoring: 1. In accordance with VA regulations, a record-keeping system will be established and maintained by the COR to ensure contract compliance. 2. The Contractor and it personnel providing services under this contract shall ensure 100% turnaround of all abstracting cases, edits, master patient index annotation, and patient care evaluation and program assessment. 3. The Contractor and its personnel shall have and use established regular quality control procedures to ensure quality, accuracy and consistency, and to ensure that all serviced provided under this contract are provided in a manner to ensure work is error free and of the highest quality. 4. Quality Assurance on 10% randomly selected cases will be performed by the facility POC in conjunction with Cancer Committee appointed representatives in regard to follow-up and abstracting 5. Before approval of payment of contractor's invoice by the COR, the delinquent medical records report will be reviewed for accuracy in order to verify services have been provided. 6. Once verification of services is established, payment will be authorized by the COR. GCVHCS RESPONSIBILITIES: 1. The Government reserves the right to reduce and/or cancel the terms of the contract with a 30-day notice if recruitment efforts prove successful. 2. Provide computer passwords for Contractor personnel performing contractual services. 3. Allow computer access to the electronic medical records and programs maintained in the VHA data system. 4. The facility POCs and/or the COR will be available to provide technical support on the use of the computer systems, policies and any other areas pertinent to the contract. 5. VHA staff will be responsible for annual reports, follow-up letters, contacts 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 hospital needs, and reporting to all state and national agencies as needed. Facility POCs will be accountable for providing this service as needed. 6. Managing physicians will be responsible for the staging of newly diagnosed cancer cases. The stages reported by the managing physicians will be posted to the appropriate cases in the fields Physician's Stage and Physician Staging when available. F. Record-Keeping System/Invoices: A record-keeping system of contractor hours of duty shall be established by GCVHCS. The contractor shall submit monthly in arrears an invoice for services performed under this contract during the month, and only one payment per month will be made. Invoices submitted shall show the total hours worked. All invoices applicable to this contract must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the Contracting Officer. G. Performance Standards: Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Cancer Registry Tasks 1 Records maintenance, including completion of abstraction Tumor registry services are conducted using VISTA, CPRS, and Oncotrax systems; services include chart abstracting, case finding, case rejections and consult support services 100% Run monthly reports through VISTA identifying cases, unresolved issues 2 Case abstracting and coding Complete abstract must be completed within 6 months of the date of diagnosis for those cases assigned a confirmed accession number 100% Within 6 months of date of diagnosis case abstract must be completed; run reports to review exceptions