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Contract Opportunity Sources Sought Notice * * * * * * * CLASSIFICATION CODE SUBJECT CONTRACTING OFFICE'S ZIP-CODE SOLICITATION NUMBER RESPONSE DATE (MM-DD-YYYY) ARCHIVE DAYS AFTER THE RESPONSE DATE R... Contract Opportunity Sources Sought Notice * * * * * * * CLASSIFICATION CODE SUBJECT CONTRACTING OFFICE'S ZIP-CODE SOLICITATION NUMBER RESPONSE DATE (MM-DD-YYYY) ARCHIVE DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS SET-ASIDE NAICS CODE CONTRACTING OFFICE ADDRESS POINT OF CONTACT (POC Information Automatically Filled from User Profile Unless Entered) DESCRIPTION See Attachment AGENCY'S URL URL DESCRIPTION AGENCY CONTACT'S EMAIL ADDRESS EMAIL DESCRIPTION ADDRESS POSTAL CODE COUNTRY ADDITIONAL INFORMATION GENERAL INFORMATION PLACE OF PERFORMANCE * = Required Field Contract Opportunity Sources Sought Notice Q301 STAT Testing Lab 98662 36C26020Q0425 05-27-2020 45 N 621511 Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662 Ty Draszt Contract Specialist 360-553-7612 Ty.draszt@va.gov Ty.draszt@va.gov Sources Sought The Boise VA Medical Center is issuing this sources sought as a means to conducting market research to identify parties having an interest in and the resources to support a requirement of STAT laboratory testing for a base period and 4 option years. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified sources for STAT laboratory testing. This is not a request for quotations. The Department of Veterans Affairs, NCO20 is looking for sources of the following: STAT Tests Co-oximetry Panel Gentamicin Peak/Trough Theophylline Thrombin Time Mono Screen Phenobarbital Malaria Smear Biofire meningitis Procalcitonin Beta HCG Quant Blood Gas PH STATEMENT OF WORK The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results. All requirements and provisions defined in the specifications of this statement of work will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory. Period of Performance: Base (07/01/20 06/30/2021), plus 4 option years. 1. General The Reference Laboratory shall provide laboratory services to include pre- analytic processing as defined in its laboratory manual; analysis, reporting of analytical results, and interpretation. The Reference Laboratory must provide the following services: Contractor shall provide STAT laboratory testing as needed due to instrument interference, test availability or instrument mal function. Contractor shall notify VAMC of any specimen problems within 1 hour of specimen receipt. STAT testing will be must be performed so that results can be delivered within an hour and testing completed within 2 hours of specimen receipt. If testing is delayed, notify VAMC of the estimated TAT. STAT test results will be called and faxed to VAMC as soon as the test results are available. Specimens will be delivered to testing facility via contracted VA courier. Routine test results shall be reported within the published test TAT. If testing is delayed, notify VAMC of the new estimated TAT. Critical Valves will be called to VAMC as soon as the test results are available. Consult with Laboratory on test results by telephone as needed. Provide VAMC Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests, 24 hours per day, 7 days per week. Billing summaries shall begin the first day of the month and include the last day of the month. The contractor shall be responsible storing specimens for at least 7 days from the completed date of testing in such a manner as to ensure the integrity of the specimen where applicable. Contractor shall supply any special preservatives required for specimen preservation. 2. LICENSING AND ACCREDITATION Contractor shall provide copies of all licenses, permits, accreditation and certificates required by law. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. All medical facilities providing laboratory services under the contract must possess a valid state license and meet JC standards as well as CLIA requirements and standards of the College of American Pathologists (CAP). 3. SERVICE The contractor shall always provide telephone number(s) and contact person to be used by the VAMC to make specimen problem inquiries and problem-solving including weekends and holidays. The contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control. Contractor shall advise facility of any changes in methodology, procedure, reference ranges, and delays in testing. Exception handling: Contractor will notify VAMC, Laboratory Service within 1 hour of any problems with specimens received. 4. TESTING METHODOLOGY, REFERENCE AND TURN AROUND TIME Testing methodology and reference ranges for a test must be defined in the laboratory user manual. 5. PERSONNEL The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. The Government s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4. 6. HOURS OF OPERATION The Contractor shall perform the services required under this contract 24 hours a day, 7 days a week, 12 months of the year. SECURITY The C & A requirements do not apply, and a Security Accreditation Package is not required PRIVACY The Reference Laboratory shall not use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law. The Reference Laboratory shall use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement. The Reference Laboratory shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors. The Reference Laboratory shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors. Custody of VA Information Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data General, FAR 52.227-14(d)(1). VA information should not be co-mingled, if possible, with any other data on the contractor/subcontractor's 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'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 follow 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 the 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 VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-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 to 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 date used by the contractor/subcontractor needs to be restored in 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 FAR Part 12. 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, the 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 COTR. 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 Contracting Officer and 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. To the extent known by the contractor/subcontractor, the 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 contract. In instances of theft, 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 38U.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 the 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 of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date 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: 1. Nature of event (loss, theft, unauthorized access); 2. Description of the event, including: a. Date of occurrence b. Date 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 date access to the lost, stolen, or improperly accessed data considering 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 date 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. Based on the determinations of the independent risk analysis; the contractor shall be responsible for paying to the VA liquidated damages 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 report 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 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. Within 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. Potential sources shall provide, at a minimum, the following information to Point of Contact listed below: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 621511 Medical Laboratories. To be considered a small business your company must have fewer than 1,250 employees. 3) Any Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who responds to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 4) The Non-Manufacturer Rule (NMR) will apply if there is a decision to set-aside the procurement. 5) Potential sources shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. This procurement is for new products ONLY; no remanufactured or "gray market" items. All products must be covered by the manufacturer's warranty. Responses are due by 05/27/2020 10:00 AM PST, to the Point of Contact. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). Point of Contact: Ty Draszt, Contract Specialist Ty.Draszt@va.gov, 360-553-7612