FILE | Q | ONCOLOGY-RELATED LABORATORY TESTING AND ANCILLARY SERVICES - Attachment

FBO DAILY ISSUE OF JANUARY 15, 2011 FBO #3339
DOCUMENT

Q -- ONCOLOGY-RELATED LABORATORY TESTING AND ANCILLARY SERVICES - Attachment

Notice Date: 1/13/2011
Notice Type: Attachment
NAICS: 621511 — Medical Laboratories
Contracting Office: Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
ZIP Code: 02301
Solicitation Number: VA24110RQ0688
Archive Date: 3/14/2011
Point of Contact: Audrey Wooten
E-Mail Address: cting
Small Business Set-Aside: N/A
Description: The Department of Veterans Affairs, VA Boston Healthcare System, intends to negotiate a commercial (FAR Part 12) sole source contract with Myraid Genetic Laboratories Inc. under the authority of FAR 6.302-1. This is not a solicitation; it is notice of intent to sole source a requirement. Inquiries/information received after the established deadline shall not be considered. The submission of any data for review shall not impede award of this contract as planned. The Government does not intend to pay for information solicited. This combined/synopsis solicitation is issued pursuant to FAR 6.302-1. This combined synopsis/solicitation for commercial items prepared in accordance with the format prescribed in the Federal Acquisition Regulations (FAR) subpart 12.6 as supplemented with additional information included in this notice under FAR part 5.203. This combined/synopsis solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-37. The North American Industry Classification System (NAICS) number is 541711; the business size is 500 employees. Offeror must be registered in the Central Contractor Registration (CCR) database before an award can be made to them. If the offeror is not registered in the CCR, it may do so through the CCR website at http://www.ccr.gov. Please provide a valid DUNS # with your submission. Offeror must comply with the following commercial item terms and conditions, which are incorporated herein by reference: FAR 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition; FAR 52.212-3, Offeror Representations and Certifications - Commercial Items - the selected offeror must submit a completed copy of the listed representations and certifications; FAR 52.212-4, Contract Terms and Conditions - Commercial Items; FAR 52.212-5, 52.246-4, 52-232-18,52-217-8,52.217-9,52.216-21, 52216.19:52.252-2: 52.204-7, 52.217-6, 52.224-1, 52.224-2,52.249-1. VAAR CLAUSES: 852.203-70; 852.203-71, 852.215-70,852.215.71, 852.237-70, 852.273-75, 852.276.76,852.216.70, The full text of the referenced FAR clauses may be accessed electronically at http://www.acqnet.gov/far. THIS IS NOT A REQUEST FOR COMPETITIVE QUOTES and no solicitation will be issued; however, any firm that believes it can meet these requirements may give written notification to the Contracting Office. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Responses are due by 01/19/2011 at 10:00AM. 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. STATEMENT OF WORK DEFINITIONS Test Result Report - A printed final copy of laboratory testing results. Proficiency Testing- An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so. POC- Point of Contact Description/Specifications/Statement of work The contractor shall provide testing for oncology-related laboratory testing and ancillary services (all BRAC Analysis) related to test methodology, understanding results, and medical management options on VISN 1 patient specimens. This is a strictly fee for service agreement. The VA Medical Centers listed Attachment A is participants in this contract. Test mix and volume is estimated and subject to change. 1. CONTRACTING LABORATORY shall perform testing entirely upon their premises. 2. CONTRACTING LABORATORY shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations 3. CONTRACTING LABORATORY shall provide individual patient-chartable test result reports meeting CLIA requirements and must be electronically transmitted to each POC for local printing. Printed reports will include: The name and address of the contract laboratory where each test was performed The specimen accession number of the contract laboratory The name of the contract Laboratory Director or Medical Director. A phone number to contact the contract laboratory concerning the test results. The contract laboratory 冱 CLIA certification number. The patient 冱 name. The patient 冱 SSN. The patient 冱 age or date of birth. The patient 冱 sex. The Medical Center/CBOC specimen identification number. The specimen collection date. The Contractor 冱 report date and time. The test name. The test result(s). The unit of measurement for quantitative tests. The normal or expected range (reference range adjusted for age, sex, or race when appropriate). The report status (i.e., final or interim). Other interpretive information appropriate for the test(s). CPT Code. 4. In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor must, without additional charge, provide express overnight shipping or courier delivery of printed reports to each POC until the automated information system is properly functioning. 5.The CONTRACTING LABORATORY must provide running history for lab results by patient when requested. 6. Appropriate requisition forms and unique supplies needed for specialized collection of samples are to be supplied by the CONTRACTING LABORATORY at no additional charge. 7. Notwithstanding anything to the contrary in this Agreement or otherwise, the CONTRACTING LABORATORY shall not release patient 冱 records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All member records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient 冱 records. This provision shall survive termination of this Agreement. 8. The CONTRACTING LABORATORY shall certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VISN 1 site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). LICENSING AND ACCREDITATION- CONTRACTING LABORATORY 1. Shall have all licenses, permits, accreditation certificates required by law. 2. Shall be accredited by the CLIA or the College of American Pathologists. Copies of all certifications and renewal certifications will be provided upon submission of a proposal to the Contracting Officer and Contracting Officer 冱 Technical Representative (COTR). 3. Medical Director must be licensed Physician with suitable qualifications and experience to direct a laboratory providing testing under this contract according to CLIA and CAP standards. 4. Must submit a copy of the professional certification and/or licensure of the Laboratory Director and/or Medical Director to the COTR with proposal. 5. Must comply with the regulatory requirements of Health and Human Services Health Care Financing Administration. 6. Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. QUALITY CONTROL: To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract. 1. Proficiency testing data will include challenged/failed, a list of tests outside of the +/- 2SD range for the past (2) years. CONTRACTING LABORATORY shall notify VA of any test outside +/- 2 SD range during contract period. 2. The VA will maintain an Internal Quality Control Program to monitor the quality of test results received from CONTRACTING LABORATORY. SERVICE: 1. CONTRACTING LABORATORY shall provide a Laboratory Manual containing the following information: Department hours of operation Accreditation Technical Staff Service Departments( Method of contacting, phone numbers, hours of availability) Quality Assurance Information such as but not limited to specimen labeling and rejection criteria Billing Procedures & fee schedules for services provided Procedures and criteria for phoning reports and other important information Report forms 2. CONTRACTING LABORATORY shall provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving at all times including weekends and holidays. *NOTE: Also include names and telephone number(s) of technical Directors and Pathologists available for consultation. 3. CONTRACTING LABORATORY agrees to maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. 4. CONTRACTING LABORATORY shall assign a specific local account representative. 5. CONTRACTING LABORATORY shall advise facility of any changes in methodology, procedure or reference ranges. TELECOMMUNICATIONS: 1. The VA Lab shall receive transmissions of test results via fax at the fax numbers listed in Attachment A. SECURITY CLAUSES: 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. (END OF CLAUSE) ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 1. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. 2. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. 3. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor 冱 employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE 1. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). 2. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor 冱 information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA 冱 information is returned to the VA or destroyed in accordance with VA 冱 sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. 3. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. 4. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. 5. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. 6. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. 7. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. 8. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. 9. The contractor/subcontractor 冱 firewall and Web services security controls, if applicable, shall meet or exceed VA 冱 minimum requirements. VA Configuration Guidelines are available upon request. 10. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA 冱 prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. 11. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 12. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE 1. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor 冱 security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA 冱 network involving VA information must be reviewed and approved by VA prior to implementation. 2. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. 3. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor 冱 systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. 4. The contractor/subcontractor 冱 system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA 冱 POA&M management process. The contractor/subcontractor must use VA 冱 POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. 5. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. 6. VA prohibits the installation and use of personally-owned or contractor/subcontract or owned equipment or software on VA 冱 network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. 7. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. 8. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA 冱 initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. SECURITY INCIDENT INVESTIGATION 1. The term 徭ecurity 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 COTR 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. 2. To the extent known by the contractor/subcontractor, the contractor/subcontractor 冱 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. 3. 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. 4. 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. FEE SCHEDULE: See Attachment B. Test price is inclusive of specimen transport to Contracting Laboratory. Each test kit is supplied with a pre-paid FEDEX shipping lab. PAYMENT 1. Payments shall be made via 2237 (certified invoice). VISN 1 Consolidated Monthly invoices to include testing for all sites listed in Attachment A should be sent to: Department of Veteran's Affairs Financial Services Center P.O. Box 149971 Austin, TX 78714-9975 For inquiries by the vendor, the vendor should call 512-460-5380 or toll free 1-877-353-9791 The following information is required on each certified invoice: 1. A valid certified PO number 2. Vendor's name and remittance address. 3. Invoice number or other payment identification that the vendor will designate. 4. Date of invoice. 5. Description of goods or services purchased, quantity of each item, and unit price of each item. 6. Total dollar amount of invoice. 7. Discount terms, if applicable. 8. Tax ID Number 2. Contracting Officer 冱 Technical Representative: Mary-Ann Bridgwood, MS (523/A5) Program Manager, NCL Boston Healthcare System 940 Belmont St. Brockton, MA 02301 3. Contractor shall invoice monthly for services rendered. Payment shall be processed thirty (30) days from receipt of proper invoice. The Government will: 1. Perform specimen collection (e.g., phlebotomy services) to obtain acceptable specimens from patients unless otherwise specified in which case will be negotiated with the contractor. 2. The Government will provide biologic specimens that have been collected and processed (centrifuged and separated, labeled, and preserved) per the Contractor 冱 published pre-analytical requirements, and in accordance with good laboratory practices (GLP). 3. Order required tests in, VISTA, or other LIS, if available, and provide the Contractor with test requests, lists or work documents with required patient demographics and ordering information. For these automated sites, the Government will not complete additional Contractor 冱 forms, data entry or test requisitions in the Contractor 冱 automated laboratory system. 4. For each test requisition, Government personnel will provide: Patient 冱 full name. Patient 冱 SSN. SA Accession Number. Date of Specimen Collection. Date Specimen Shipped. Test(s) Requested/Code and Name. Ordering Physician 冱 Name. Ordering Remarks/Comments (if clinically appropriate). Patient 冱 Age or Date of Birth. Patient 冱 Sex. Type of Specimen Patient 冱 location (clinic/ward) 5. Ensure timely transportation for delivery to the CONTRACTING LABORATORY. B.3 Price Schedule Comprehensive BRACAnalysis Full sequence and large rearrangement analysis of BRACA1 and BRACA2 Single Site BRACAnalysis Mutation-specific analysis for individuals with a known BRCA1 or BRCA2 MultiSite 3 BRACAnalysis Analysis of the three most common BRCA1 or BRCA2 Mutations in individuals of Ashkenazi Jewish ancestry Reflex BRACAnalysis BRCA1 Analysis Full sequence and large rearrangement analysis of BRCA1 BRCA2 Analysis Full sequence analysis of BRAC2 BRACAnalysis Rearrangement Test (BART) for large rearrangements in BRCA 1 and BRCA2
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Document(s): Attachment; File Name: VA-241-10-RQ-0688 VA-241-10-RQ-0688_2.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=170992&FileName=VA-241-10-RQ-0688-000.doc); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=170992&FileName=VA-241-10-RQ-0688-000.doc; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Record: SN02359782-W 20110115/110113234415-867bf45400e5e7799d23c9a0123698fa (fbodaily.com)
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Q -- ONCOLOGY-RELATED LABORATORY TESTING AND ANCILLARY SERVICES - Attachment