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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 08, 2019 FBO #6286
SOURCES SOUGHT

66 -- FEE-BASED IMMUNOHISTOCHEMICAL STAINING

Notice Date
2/6/2019
 
Notice Type
Synopsis
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106
 
ZIP Code
79106
 
Solicitation Number
36C25719R0014
 
Response Due
2/19/2019
 
Archive Date
4/20/2019
 
Point of Contact
canuto.campos@va.gov
 
Small Business Set-Aside
N/A
 
Description
The South Texas Veterans Health System Audie L. Murphy Division in San Antonio, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB) or Small Business (SB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 13. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB or Small Business firms who wish to identify their interests and capability to provide this service must provide information by notifying the Contract Specialist no later than NOON PM Central Time February 19, 2019. Notification shall be e-mailed to Phil Campos, at phil.campos@va.gov. DISCLAIMER This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE OF WORK The Contractor shall provide all labor, materials, equipment and supplies necessary to perform the below-described testing laboratory specimen testing. Contractor shall perform immunohistochemical (IHC) and/or special stains necessary within two days of receipt. Schedule of tests required include, but are not restricted to: IHC stains: Amyloid (panel, AA & P), Congo Red, Arginase-1, CD5, CD23, CD68 (KP1), CD138, CDK4, D2-40, Glypican-3, LEF1, MdM2, NKX3, p16, Pax-8 Stains may or may not require interpretation. CPT codes: 88313, 88341, 88342 Testing shall be performed to the satisfaction of the CTVHCS Chief of Laboratory and the Contracting Officer's Representative (COR). Contractor shall provide to the COR the methodology and ranges for results on all tests upon request. LAB REPORTS: All lab reports shall be clear, accurate, and informative and contain at a minimum the following information: Patient s full name Patient s Social Security Number Patient s Date of Birth Physician name Requesting Facility VA Accession Number Date and time of specimen collection Specimen type Name of test and test code ordered Test results Normal reference range Abnormal result flags/interpretation Date and time test was completed Performing laboratory REPORTING ROUTINE RESULTS: Contractor shall provide results to CTVHCS as directed: The contractor shall transmit results via fax to CTVHCS at fax number (254) 743-0126. CLINIC CONTACTS: Contractor shall consult with CTVHCS pathology staff on test results via phone as needed. CONTRACTOR POINT OF CONTACT: The following point of contact shall be notified when immediate inquiry regarding a pending test(s) is required: CTVHCS reference laboratory POC: Deborah Burns Telephone number: (254) 743-0455 Fax number: (254) 743-0126 CTVHCS POINT OF CONTACT: Contractor shall contact the following to report STAT and Critical Value test results: Monday through Friday: 7:00 a.m. through 4:00 p.m. 254-743-0455 or 254-743-0891 Fax number: 254-743-0126 After hours and holidays: Call Supervisor/Lead Technologist on duty: 254-743-0797 ORDERS: The contractor shall receive requests for lab services in writing or electronically. The requisition form shall include the following information: Patient's full name Social Security number Patient s Date of Birth Requesting facility Attending physician name Laboratory Test requested Type of specimen Date test ordered VA Accession number Date and time specimen collected Priority Level of Test PAYMENT: The VA shall not be responsible for payment for services which were not requested in accordance with paragraph #4. TRANSPORTATION OF SPECIMENS: Specimens shall be transported in such a manner as to ensure the integrity of the specimen and established in accordance with government regulations. Frozen specimens shall be maintained in a frozen state during transport. LICENSING AND ACCREDITATION: Contractor shall have all licenses, permits, accreditation and certificates required by law. Personnel assigned by the contractor to perform these services covered under this contract shall be nationally certified. The lab must be accredited by the College of American Pathologists (CAP) and have a Clinical Laboratory Improvement Act (CLIA) (Public Law 100-578) certificate. Contractor must submit proof of CAP or The Joint Commission accreditation and a copy of the CLIA certification along with their offer. Laboratory Director must meet CLIA qualifications. QUALITY CONTROLS: By the 20th of each month following the end of the quarter, the contractor shall provide to the COR a · cumulative summary report by test. The report shall include the TAT for each test order during that quarter. The VA shall have access to inspect the contractor's facilities, equipment and records. The results of these inspections shall be published and given to the contractor. Contractor shall immediately advise the laboratory director of any changes in methodology, procedure, reference ranges and any new test introduced. In the event the contractor changes the assay procedures or a critically important component of an assay (e.g. an antibody, purified antigen, etc.) the contractor shall notify the laboratory director prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged and improved. Contractor shall provide, upon request, the following information during the life of the contract: Indication of average monthly volume of specified tests listed in this contract. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs. Provide address of processing sites under contract, including subcontracted testing location sites. The Government may evaluate the quality of the professional and administrative services provided but retain no control over the medical professional aspects of services rendered (e.g. Professional judgments, diagnosis for specific medical treatment). INVOICING: Invoices must contain at a minimum the following information. Contractor shall provide this information on one original invoice: Contract number Purchase Order number Patient Name Date of birth Date of Service Test Number and Name VA accession number Proper CPT Code Unit Cost Total Cost GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the CTVHCS without the consent from CTVHCS. The CA requirements do not apply and a Security Accreditation Package is not required. SECURITY: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS: A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. 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. 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's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE 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). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems 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's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite 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. 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. 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. 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. 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. 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. 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. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. 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's 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. 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. 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 COR. SECURITY INCIDENT INVESTIGATION 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. 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. 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. 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. LIQUIDATED DAMAGES FOR DATA BREACH 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 SPI the contractor/subcontractor processes or maintains under this contract. 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. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any Pll, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and 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. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (06-FEB-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 
Web Link
Link To Document
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25719R0014/listing.html)
 
Place of Performance
Address: SouthTexas Veterans Health System;Audie L. Murphey Division;7400 Merton Minter Blvd;San Antonio, Texas
Zip Code: 78229
Country: United States
 
Record
SN05214109-F 20190208/190206230026 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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