Q301--Notice of Intent to Sole Source ---- Affiliate: Maine General Hospital STAT Testing (10-YR POP: 02/01/2023 - 01/31/2033)

Pre-solicitation Notice of Intent to Sole Source Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with affiliate Maine General Hospital, 35 Medical Center Pkwy, Augusta, ME 04330. The purpose of this acquisition is to obtain a 10-Year BPA: 02/01/2023 01/31/2033. Tests to be included: The contractor shall provide STAT and other select lab testing services covering all CPT codes from 8000-9999 as well as the other tests listed within PWS. VA Maine Healthcare System STAT & Select Lab Testing Services Performance Work Statement (PWS) Definitions: Stat Test- A test required within 60 minutes of receipt by the contractor that is specially handled, tested and reported, within the specified turn-around-time. Routine Test - A test that is usually performed at high volume in which the result is generally required within 24 hours. TAT- The length of elapsed time between receipt of the specimen at the contractor s laboratory until receipt of the completed printed/faxed/phoned report back at the sending laboratory. Test Result Report - A printed final copy of laboratory testing results. Critical Value- Those test results that require evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of critical value might cause harm to a patient. POC- Point of Contact VistA- VA Medical Center computer system STAT Tests & Other Select Lab Testing Services Tests needed are described below, labeled Attachment A Test Menu. General: Services are required to perform off-site STAT and other select lab testing services for the VA Maine Healthcare System (HCS), Augusta Campus (hereinafter referred to as VAMEHCS). This contract shall cover STAT and select other lab testing service described below under Attachment A Test Menu. The services would be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to perform STAT lab testing services as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Objectives: STAT lab testing services (off-site) Select other lab testing services (see Attachment A Test Menu below) Scope: The contractor shall provide STAT and other select lab testing services covering all CPT codes from 8000-9999. Histology specimen processing to include processing of blocks and preparing H&E slides. Contractor shall provide professional and technical services to include materials, supplies, equipment, and qualified supervision specified herein. All services shall be performed at the Contractor s facility. Location: VA Maine HCS located at 1 VA Center, Augusta, Maine 04330 Period of Performance: The period of performance shall be for a base year of 12 months and nine (9) potential 12-month option years. Option years are exercised at the discretion of the Government. General Information: The Contractor Laboratory: Shall provide STAT and other select lab testing services (off-site) Contractor shall perform STAT analytical testing for VAMEHCS patients for the tests defined on the STAT listed in the Test Menu. Shall perform testing services entirely upon their premises. The Contractor is required to provide a report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations. Reporting of Results: All STAT test results shall be called to the VAMEHCS Laboratory Staff within 60 minutes of specimen receipt by the contractor. Critical Test Results shall be called with 15 minutes of the result being deemed acceptable by the contractor. Contractor shall submit all VA tests results to VAMEHCS Laboratory Staff via facsimile (207) 621-4878 (Chemistry/Sendout Section) In addition, test result reports shall be mailed to the VAMEHCS for entry into the patient s chart: VA Maine HCS Laboratory, 1 VA Center, MDP 113, ATTN: Sendouts, Augusta, Maine 04330 Contractor must be located within a 10-mile radius of VA Maine HCS, based on TAT requirement for STAT testing services. The contractor shall provide a Laboratory Manual to include testing methodology and contain the following information for testing services: Department hours of operation Accreditation: CAP & CLIA Technical Staff Service Departments (Method of contacting, phone numbers, hours of availability) Quality Assurance Information Billing Procedures & fee schedules for services provided Procedures and criteria for phoning reports and other important information Report forms The contractor shall provide telephone number(s) and contact person(s) to be used by the VAMEHCS to make specimen problem inquiries and problem solving at all times including weekends and holidays. Must include names and telephone number(s) of Technical Directors and Pathologists available for consultation. Contractor agrees to maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification shall be given to VA upon adverse action by a regulatory agency. Contractor shall assign a specific local account representative. Contractor shall advise facility of any changes in methodology, procedure or reference ranges at least 14 days prior to the changes. In the event that two-week notification is not possible due to emergency, contractor shall notify VAMEHCS as soon as possible. Shall perform testing as needed 24 hours per day/7 days per week including holidays. Contractor shall consult VA Maine HCS on test results by telephone as needed (207-623-8411, x4877). The Contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. Hard copy results and consultative reports shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Act of 1988 (CLIA) requirements. Faxed/Printed reports shall 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 The date and time a specimen was collected at the VAMEHCS The date and time a specimen was received by the laboratory and completed The pathologist or technologist signature, as appropriate A phone number to contact the Contract Laboratory concerning the test results The patient s name The patient s SSN The patient s ICN/EDIPI The patient s age or date of birth The patient s sex The VAMEHCS specimen accession/identification number The Contractor s report date and time The test name(s) 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, as appropriate) Other interpretive information appropriate for the test(s) CPT code and any other information the laboratory has that may indicate questionable validity of test results, Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. The contractor laboratory shall not release patient s 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 s records. This provision shall survive termination of the resulting contract award. Shall certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMEHCS 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 Contractor Laboratory: Shall have all licenses, permits, accreditation certificates required by Federal and State law in Maine. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer s Representative (COR) to include the contractor laboratory s Laboratory Director and/or Medical Director. Medical Director shall have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board. Must comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS). Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. Shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention. Contract Performance Monitoring Evaluation Factors: STAT test results shall be called to the VAMEHCS Laboratory Staff within 60 minutes of specimen receipt by the contractor. Critical Test Results shall be called with 15 minutes of the result being deemed acceptable by the contractor. Contractor shall provide written laboratory reports to the authorizing VAMEHCS Contractor shall maintain CLIA or CAP and AABB accreditation Quality Control/Assurance (QC): The contractor must operate a successful quality control program as required by CAP or CLIA and AABB certified. Services are to be performed in accordance with this PWS. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which the contractor laboratory assures that work complies with the requirements of the contract. A Quality Assurance Surveillance Plan (QASP) shall be submitted as part of an offer and put into place upon final contract award. After acceptance of the quality control plan the contractor shall receive the contracting officer s acceptance in writing of any proposed change to this Quality Assurance system. The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission and regulations required as required for performing the type of services required. The government shall evaluate the contractor s performance under this contract in accordance with the QASP. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). Federal Holidays: (The contractor shall need to perform on these holidays and any other days specifically declared by the President of the United States to be a national holiday. New Year s Day Labor Day Martin Luther King Jr. s Birthday Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Independence Day Christmas Day Juneteenth Hours of Operation: The contractor is responsible for providing services 24 hours per day/ 7 days per week, including the holidays referenced above. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract. Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contractor laboratory. Any specimen that is lost by the contractor laboratory will incur a charge of $100.00 and will be credited to the Government on the monthly invoice. The contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy and Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information. Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend a post award conference convened by the contracting activity in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the Contracting Officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the Contracting Officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7:30 a.m. to 4:00p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons. Identification of Contractor Employees: All contract personnel attending meetings and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract. Privacy Language for Statement of Work (SOW) Contactor policies and procedures shall comply with all VA Privacy & Security, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). Records Management Language for Statement of Work (SOW): The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL 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. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontrator 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. b. 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. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. 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. e. 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. 3. VA INFORMATION CUSTODIAL LANGUAGE a. 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). b. VA information should not be co-mingled, if possible, with any other data on the contractors/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 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. c. 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. d. 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. e. 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. f. 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. g. 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. h. 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. i. 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. j. 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. k. 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. l. 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. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. g. The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: (a) The Systems of Records (SOR); and (b) The design, development, or operation work that the contractor/subcontractor is to perform; (1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and (2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. (1) Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. (2) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and crimi...