Inactive

*= Required Field Sources Sought Notice Page 1 of 11 This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or comm... *= Required Field Sources Sought Notice Page 1 of 11 This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Department of Veterans Affairs Audie L. Murphy VA Hospital Pathology/Laboratory Medicine Service in San Antonio, Texas intends to award a brand name or equal contract award for the purchase of Breast Cancer Index (BCI). The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 621511 with a size standard of $35M. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 20.00 EA BREAST CANCER INDEX TEST - CPT 81518 Base Year: 03/1/2022 - 2/28/2023 0002 20.00 EA MICRODISSECTION, CPT CODE: 88380 Base Year: 03/1/2022 - 2/28/2023 1001 20.00 EA BREAST CANCER INDEX TEST - CPT 81518 Option Year 1: 03/1/2023 - 2/28/2024 1002 20.00 EA MICRODISSECTION, CPT CODE: 88380 Option Year 1: 03/1/2023 - 2/28/2024 2001 20.00 EA BREAST CANCER INDEX TEST - CPT 81518 Option Year 2: 03/1/2024 - 2/28/2025 2002 20.00 EA MICRODISSECTION, CPT CODE: 88380 Option Year 2: 03/1/2024 - 2/28/2025 3001 20.00 EA BREAST CANCER INDEX TEST - CPT 81518 Option Year 3: 03/1/2025 - 2/28/2026 3002 20.00 EA MICRODISSECTION, CPT CODE: 88380 Option Year 3: 03/1/2025 - 2/28/2026 4001 20.00 EA BREAST CANCER INDEX TEST - CPT 81518 Option Year 4: 03/1/2026 - 2/28/2027 4002 20.00 EA MICRODISSECTION, CPT CODE: 88380 Option Year 4: 03/1/2026 - 2/28/2027 Statement of Work I. SCOPE OF WORK The STVHCS Audie L. Murphy VA Hospital has a need for Breast Cancer Index and Microdissection testing. The purpose of the resulting contract will be to provide a Blanket Purchase Agreement (BPA) for Breast Cancer Index and Microdissection testing for the South Texas Veterans Health Care System (STVHCS), Audie L. Murphy Division located at 7400 Merton Minter Blvd., San Antonio, TX 78229-4404. Contractors shall provide in accordance with the specifications outlined below, referral laboratory services to include Breast Cancer Index testing, Shipping materials for the Audie L. Murphy VA and Kerrville VA laboratories, for with a Base + 3-year option renewal. The BCI test is for hormone receptor-positive (HR+), early-stage breast cancer patients to determine course of treatment. This test has been added to the NCCN Breast Cancer Guidelines. This test is the only gene expression assay for prediction of benefit from extended endocrine therapy. Services at minimum must include: The performance of analytical testing as defined by the Contractor's reference test manual and the required testing listed on Attachment A, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to STVHCS and any supplies needed to ship specimens according to Federal and State Requirements of Category A and B Specimens. The Contractor will provide supplies and shipping materials and account to send specimens. NOTE: Attachment A is an estimate of required testing based upon prior history of actual volumes and are not a guaranteed minimum. This list serves only as base guideline of tests required by the STVHCS. Vendor should be able to provide pricing guidelines for all other tests not listed on Attachment A. All requirements and provisions defined in the specifications of this solicitation shall apply to any laboratory, i.e., branch, division, Sub Contractor, etc. performing reference testing on behalf of the Contractor. II. DESCRIPTION OF SERVICES Requirements/Services to Be Provided: A. Specimen Testing A.1 The Contractor shall provide timely (defined by the minimum and maximum turnaround times detailed in the description of requirements) and appropriate testing of patient specimens as requested by STVHCS facilities. A.2 The STVHCS facilities reserve the right to select other testing methodologies than offered by the Contractor's laboratory for appropriate reasons, i.e., better clinical quality, research studies or those determined for performance at STVHCS centers of excellence. STVHCS facilities that identify such a testing methodology not meeting their testing criteria must submit a request for review to a STVHCS adjudicating panel with sufficient justification to warrant an exemption from the contract. These rare test exemptions will be re-referred to another reference laboratory and the costs borne by the requesting STVHCS facility. A.3 The STVHCS facilities reserve the right to identify testing issues with the Contractor s laboratory test results due to inconsistent results and/or testing accuracy (i.e., positive blood culture that has a final report of no growth, false positive screen that is reported as negative, inconsistent gram stain result when compared to the final report, etc.). A.4 The STVHCS facilities reserve the right to identify testing concerns with the Contractor s laboratory due to testing delays (i.e., no notification of sample issues, reports not labeled correctly, or an increase noted in the number of corrected reports, etc.). A.5 In order to minimize the number of tubes drawn, the contractor, annually shall evaluate each site commonly ordered tests, working with the individual sites, develop a test order numbers that shall combine applicable tests; therefore, reducing the number of reference test samples drawn. B. Sample Processing B.1 Each STVHCS facility will provide laboratory specimens properly collected identified with both the Patient s Identification (as utilized by each facility) and requested tests. For those specimens that require special handling, the Contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis (i.e., dry ice, stabilizing tablets, ice packets, 24-hour collection container with preservatives, special collection tubes, etc.). B.2 The Contractor shall be responsible for transporting and storing specimens in such a manner as to ensure the integrity of the specimen. Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals (e.g., boric acid tablets, acids). C. Transportation Services for the VA Facilities C.1 The Contractor shall provide reference testing shipping materials and or/transportation services between the STVHCS and contracted laboratory. Service shall include minimally one (1) pick-up per day at each facility if applicable. Time frames as follows: Monday - Friday excluding holidays (holidays for the purpose of the attachment shall be defined as: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, and Christmas day). STAT pick-ups shall be Monday through Friday between 8:00 am and 5:00 pm. Pick-ups and deliveries may be needed on an as needed basis. Facility shall notify Contractor of the need for each unscheduled pick-up by phone. In order to maintain the integrity of laboratory samples, they shall be transported by the Contractor in a manner that shall not interfere with specimen integrity or quality. D. Reporting of Results D.1 A report is defined as a printed final copy of the laboratory testing results or host-to-host electronic transmission of test results. This report as defined by the individual facility shall be received by either: computer interface, fax, and /or messenger delivery. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the Telecommunication Requirements section of this solicitation. D.2 Each test report shall at minimum indicate the following information: Patient's name and/or identification number Physician's name (if supplied) VISN 17 medical record number or laboratory accession number (if supplied) VISN 17 submitting facility name Patient's location (clinic/ward) (if supplied) Test ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference intervals Toxic and therapeutic ranges, if applicable Flagged abnormal test results Reference laboratory specimen number Name of testing laboratory, if other than Contractor Any other information the laboratory has that may indicate a questionable validity of test results Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing D.3 Test results shall be received within 24 hours if applicable following specimen pick-up either by hard copy or electronic report transmission. It is recognized that certain test procedures will require a longer turn-around time than the 24 hours. The Contractor shall provide a list of the estimated turn-around time for any tests that require longer than 24 hours to complete. D.4 Notification of a test result that has been identified in the commercial reference Contractor laboratory as a critical or alert value shall be communicated by telephone to the submitting VISN 17 laboratory upon verification of the critical or alert test result. A hard copy result must follow any telephonic reporting either by fax or computer-generated report. D.5 Contractor shall provide daily, by 12:00 PM, a report listing all incomplete specimens and their processing status. D.6 The Contractor shall state their policy and any associated fees for repeat testing if requested by the provider. E. Customer Service E.1 The Contractor shall provide in response to this solicitation a detailed plan describing their customer service strategies for STVHCS if Contractor's specimen processing personnel are located on site at the facility or if they are not located on site at the facility. This plan shall address the capability and/or availability of the commercial reference laboratory Contractor to provide the following services and, if applicable; specify how this service will be accomplished, by whom, and within what timeframe: E.2 Telephone Inquiries: Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the VA minimum time expectation for meeting this service. Specimen Collection Routine inquiries where the reference laboratory performs the actual testing - if further clarification on the collection requirements are needed, shall be addressed at the time of the inquiry. Esoteric inquiries, where the information on the availability and/or requirements of the questioned test requires further research, shall be addressed within ½ hour of the initial inquiry. Testing Status of Ordered Testing - inquiries regarding the status of pending orders shall be addressed at the time of the inquiry. Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two (2) hours of the initial inquiry. Technical Expertise Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two (2) hours of initial inquiry. Result interpretation inquiries shall be addressed within four (4) hours of initial inquiry. Consultative services where information is required regarding the clinical significance of test or inquiries by the provider into what is the best test to order for more effective patient care shall be addressed within twenty-four (24) hours of the initial inquiry. Computer interface questions where information is required to update, maintain, and support the services of the host-to-host linkage between the VA and the Contractor shall be addressed within two (2) hours of the initial inquiry. E.3. Account Follow-up a) Account follow-up that requires information general in nature yet specific to the account, e.g., test pricing, courier service problems, specimen results discrepancy issues, equipment repair, supply ordering, etc. shall be addressed within four (4) hours of the initial inquiry. F. Data Management System a) Test ordering is easily accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It shall also alert the user to the location of the laboratory that will be performing the test. b) Test definitions, test information and test requirements are complete, available, and easily accessible. c) The status and the results of testing are available within published timeframes and easily retrievable using varying options. Examples of these options are through a patient search, a sort by timeframe, a sort by test, a sort of incomplete tests, etc. Incomplete tests shall have an indication of the pending time until completion. Alert messages are generated when testing is delayed beyond published timeframes, when specimens require additional testing (reflex), or when specimens are cancelled due to unacceptability. d) Reports of test results shall be immediately available upon verification of the test result. The computer must be able to print test results upon request and reprint retrospective test results according to a defined timeframe. e) Shipping manifest is generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered. f) The ordering of specimen collection and transportation supplies is accomplished through direct on-line ordering. g) Current STVHCS contracted price information is available through the computer or through other electronic modes. G. Notification Requirements G.1 The notification of critical values shall be determined by each individual facility. G.2 The notification of rejected samples shall be determined by each individual facility. The Contractor needs to specify the process their facility performs in trying to locate additional sample before rejecting a test. G.3 Telephone notification of specimens cancelled due to unacceptability, i.e., volume, specimen container identification, loss of specimen, etc. shall be determined by each individual facility. G.4 A hard copy test catalog shall be published on an annual basis and a sufficient number of copies shall be distributed to each account within the STVHCS. Addendums/ updates to the test catalog shall be made available (either electronically or in hard copy) to each STVHCS account in a reasonable timeframe (no less than two weeks) prior to the effective change of the test so that adequate preparations can be made to facilitate the test transition. The test catalog shall include all test information as required by the regulatory requirements of the College of American Pathologists. A reference guide to test interpretation shall also be available. H. Specimen Storage The Contractor shall store the specimens a minimum of seven (7) to ten (10) days after the test is reported in the event that subsequent action is necessary (i.e., problem solving, add-on test, and/or repeat testing). The Contractor shall state their specimen retention time. I. Contractor Performance I.1 The Contractor shall provide in response to this solicitation a detailed plan describing their proposal for performance improvement activities that are specific to the VISN 17 facilities identified in this solicitation. This plan shall minimally address the quality aspects representative to the testing process, i.e., pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities. I.2 The Contractors PI plan shall also include a description of their procedure for responding to issues, problems and/or concerns identified by the VISN 17 laboratories and specific information as to whom and in what time frame the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. I.3 The Contractor shall provide the STVHCS facilities with a quarterly report of the Contractor s PI monitors and data. I.4 The Contractor shall provide a detailed plan describing their Quality Assurance monitors to include completeness, accuracy, and reliability of tests results. The quality control processes should be in place for all phases of testing. The monitors may include positive identification of patient and specimen, acceptability of specimens received for testing, accuracy of data entry of test orders, accuracy of data entry of test results, revised reports, and/or lost specimens. I.5 The Contractor may offer presentations/webinars/ teleconferences of new technology updates or services. J. Utilization Reports J.1 One copy of the following reports shall be available to each STVHCS VA facility by the 20th of the month following the close of the reporting month: Monthly cumulative summary alphabetically by patient for each STVHCS VA facility indicating name, test ordered, date specimen received and ordering physician Monthly summary sheet by test frequency for each STVHCS VA facility listing patient name, volume of tests ordered, unit charge, total charges for this month and year to date. Summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory. J.2 One copy of the following reports shall be available to the network office by the 20th of the month following the close of the reporting month: Monthly summary sheet by dollar volume for each STVHCS VA facility listing tests in descending order of dollar volume with volume of tests ordered, unit charge for each test, total charges for months and year to date. Summary sheet by test frequency of the entire STVHCS laboratory utilization listing by STVHCS Primary VA facility all test ordered, the volume of tests ordered, unit charge per tests, total charges, and percent abnormal results for the period. Summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory. J.3 The Contractor shall provide access-on-demand utilization reports Utilization details and utilization spend report where each facility will have access to self-service customizable reports to analyze utilization patterns and costs. The ability to view these reports will make it faster and easier to identify improvement opportunities, promote clinically appropriate test selection, and track ongoing metrics to monitor progress for more uniform and cost-effective care. J.4 The Contractor shall annually provide a statistical analysis of the STVHCS VA facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns. J.5 The Contractor may annually offer a consultation with recommendations for each facility where they analyze the facility s testing patterns and compare them against benchmarks by time, age, and geographic site. J.6 The Contractor is encouraged to offer a spectrum of value-added incentives. Such incentives may include customer and professional service programs that assist the VISN 17 facilities with the usage of the Contractor's products in the most cost-efficient manner. K. INVOICING: Payment to be made monthly in arrears by certified invoices and must contain the contract number and obligation number in addition to the requirements detailed in 52.212-4 (G) to be considered valid. Invoices shall also contain a line item for each test and quantities billed for according to contract period of performance with dates of service for each patient. STVHCS will not pay for tests that are not clearly identified by accession number on the Contractors invoice. L. Work Hours: Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows: New Year s Day, Martin Luther King s Birthday, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated as a national holiday by the President of the United States. III. LICENSURES Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The reference laboratory shall be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency [i.e. Commission of Laboratory Accreditation (COLA), College of American Pathologists (CAP)] with deemed status from the Center for Medicare and Medicaid Services (CMS), American Associates of Blood Banks (AABB), Joint Commission (JC), Center for Disease Control (CDC), Medicare, Food and Drug Administration(FDA) and/or other state regulatory agencies as mandated by federal and state statutes and VHA Handbook 1106.1. In addition, the reference laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA). Copies of all relevant permits, licenses and certification of the Contractor and any subcontractor of the primary Contractor if tests and/or services are sent to another facility for testing, inclusive of any sanctions current or pending throughout the United States of America shall be supplied in response to this solicitation. In addition, as these documents for the Contractor and subcontracted facilities are reissued for accreditation, reworded, or renewed the awarded Contractor shall supply a copy to the STVHCS facilities annually. IV. QUALITY The Government reserves the right to physically inspect the reference laboratory(s) prior to a contract award and at any time during the award period to ensure the reference laboratory's compliance with accreditation and quality assurance practices and requirements. In addition, the reference laboratory shall provide the following documentation with their offer: Professional Staff Curricula Vitae Technical Staff Competency Skills Assessment Technical and Courier Staff Shipping and Handling of Laboratory Specimens/Hazardous Materials Training and Assessment CAP and/or any other Proficiency Exam Participation for the past two (2) years Proficiency Examination Exception Reports for the past two (2) years Policy, list of tests and associated results for critical and alert value notification Description of Performance Improvement (Quality Assurance) Program/Plan Current year performance improvement monitors that include and not limited to demonstration of number of lost/damaged specimens, number of cancelled specimens, delays in turnaround times (including but not limited to due to lack of staffing, lack of availability of reagents, instrumentation issues, etc.), resolution of complaints, errors in reporting patient results, and courier route delays/cancellations Other Quality Assurance Monitors as defined by STVHCS. VI. IMPLEMENTATION TIME FRAME The implementation of the services/requirements described in this solicitation shall be completed by the first month of the award of the contract. Failure to provide timely implementation may result in termination of the contract. The Contractor shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity and validation, client service support, courier/logistics, ordering, supplies, specimen processing services, reporting, quality assurance, billing, etc.) VII. PRODUCT ADD-ONS The Contractor and STVHCS may add new tests to the base or FSS contract over the course of the contract performance as test volumes increase or as new technology becomes available on the market. A contract modification shall be executed adding these new products to the contracted schedule of items before the Contractor can provide these products to the VISN 17 facilities. Since not all tests may be listed on the contract, due to low volume testing or facility preferences, any test that appears on the Federal Supply Schedule (FSS) fee schedule shall be billed at the FSS fee schedule amount. The Contractor shall supply a list of all tests on the FSS with their associated costs. Tests ordered from each VA facility that do not appear on either schedule shall be offered by the Contractor and will be billed at the fair/open market rate. The Contractor shall send tests to another reference facility that is not offered in-house, and the Contractor shall provide the shipping at a fair market cost. Contracting Officer Representative: Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the Contracting Officer's Representative (COR). All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB), Federal Drug Administration, College of American Pathologists (CAP) accreditation policies and all other applicable Federal, State and Government laws. Information Systems Officer, Information Protection:   The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. The contractor will have access to protected Patient Health Information (PHI) but will not have the capability of accessing patient information during the services provided to the VA. Contractor is required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws. Records Manager: There will be federal records created, maintained, used, or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]. VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE 1. SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 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. STX-HCR671-04 General Information Security Requirements /Records All information and records provided to Contractor by VA, in whatever medium, as well as all information and documents, including drafts, emails, back-up copies, hand-written notes and copies that contain such information and records gathered or created by Contractor (collectively referred to as VA information ) in the performance of this contract, regardless of storage media, are the exclusive property of VA. Contractor does not retain any property interest in these materials and will not use them for any purpose other than performance of this contract. Upon completion or termination of the contract, Contractor will either provide all copies of all VA information to VA or certify that it has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA s option. Medical records of any kind including notes shall be returned to the VA. The Contractor will not retain any copies of VA information. Where immediate return or destruction of the information is not practicable, Contractor will return or destroy the information within 30 days of completion or termination of the contract. All provisions of this contract concerning the security and protection of VA information that is the subject of this contract will continue to apply to VA information for as long as the Contractor retains it, regardless of whether the contract has been completed or terminated. Prior to termination or completion of this contract, Contractor will not destroy VA information received from VA or gat...