Inactive

The El Paso Texas VA Health Care System (ELPVAHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement l... The El Paso Texas VA Health Care System (ELPVAHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. THE VENDOR MUST BE REGISTERED AS A SMALL BUSINESS UNDER NAICS CODE 621511 TO BE CONSIDERED FOR AWARD. The North American Industry Classification System (NAICS) is 621511. Any SDVOSB or VOSB firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contracting Officer no later than 12 NOON Central Time, March 01, 2019. Notification shall be e-mailed to Ronalda Ohio, at ronalda.ohio@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. PART A- SCOPE OF WORK REFERENCE LABORATORY The El Paso Veterans Affairs Health Care System (EPVAHCS) Department of Pathology & Laboratory Service requires support from an external reference laboratory. The EPVAHCS consists of the main facility at 5001 N. Piedras, El Paso, TX 79930, the Eastside Community Based Outpatient El Paso, TX 79936 and the Las Cruces Community Based Outpatient Clinic, Las Cruces, NM 88001. 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, reference laboratory testing to the El Paso VAHCS in accordance with the Statement of Work herein. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e., branch, division; sub-Reference Laboratory, etc. performing reference testing on behalf of the Reference Laboratory. EPVAHCS anticipates servicing approximately 60,000 specimens will be referred for testing in FY19. Performance Period: The period of performance for this contract is one base year, and four option years. Type of Contract: This is a firm fixed-price contract. CATEGORY MANDATORY TESTING CAPABILITIES: a. 621-200 Anatomic Pathology b. 621-201 Clinical Chemistry c. 621-202 Cytogentics d. 621-203 Cytology e. 621-204 Clinical Drugs of Abuse and Toxicology f. 621-205 Endocrinology g. 621-206 Hematology h. 621-207 Hemostasis i. 621-208 Immunology j. 621-209 Microbiology k. 621-210 Organ or Disease Oriented Panels I. 621-211 Serology m. 621-212 Urinalysis n. The Reference Laboratory shall provide genetic testing. The genetic tests shall include the following tests: BRCA 1 & 2, HLA B5701, HLA B27, HLA DR4, HLA DQ1, HLADR2, HLA Celiac (HLA-DQA1*05, HLA-DQB1*02, & HLA-DQB1*03:02), & HLA Transplant (HLA-A, B, & DRB1). II. Specimen Preparation and Storage for Reference Testing Specimens Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. If a medic legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain a valid chain-of-custody possession and develop the formal documentation necessary for that purpose. Contractor s testing personnel who performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the Government. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen. Transportation Services for Reference Testing Specimens Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained. Routine transportation services shall occur once per day from the Government facilities listed herein at approximately 1600 each day (M-F). Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory. These supplies shall include, but may not be limited to: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Test request forms, preprinted with the appropriate Shipping Section details and account information. Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.). Printer and printer supplies including paper, labels, and toner/ ink cartridges, in sufficient quantities to perform work under this contract. III. Specimen Testing The Contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required testing annotated in Section I. Contractor shall make available the following test information: Requisition form requirements Alphabetized test name list Test order code Specimen collection and preservation requirements Test method employed (indicate if testing performed in duplicate) and interpretations Test reference intervals adjusted for age, sex or race, when required Test specific sensitivity, specificity and interferences, when required Result code Test critical values, if any Policy for critical value notification CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a Government facility. Schedule of test performance (specific days of week indicated). Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited). Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. The Contractor shall ensure the accurate and timely performance (defined in Section III.A.12) of laboratory testing services on the biomedical materials. Specimen Retention A medic legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication. Reporting of Results The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section III.A.12). A report of laboratory testing results must be issued either as a printed final copy or through the host to host electronic transmission of the test results. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in Section Telecommunication Requirements below. Each test report shall, at minimum, include the following information: Patient's full name Patient s identification number, e.g. social security number (SSN) Physician s name (if supplied) Government laboratory accession number (if supplied) Submitting facility name Submitting facility account number Patient's location (clinic/ward) (if supplied) Test(s) ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference intervals (adjusted for age, sex or race, when appropriate) Toxic and therapeutic ranges, if applicable Flagged abnormal results Reference laboratory accession number Name and address of testing laboratory Any other information the laboratory has that may indicate a questionable validity of test results. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission. Customer Service Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period: 1. Telephone Inquiries Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government s minimum time expectation for meeting this service. Specimen Collection Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within half hour of the initial call. Testing Inquiries regarding the status of pending orders shall be addressed at the time of the initial call. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call. c. Technical Expertise Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call. Result interpretation inquiries shall be addressed within four business hours of initial call. 3) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call. d. Account follow-up Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods. Consultative Services/Utilization Reports Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation. Contractor shall provide a statistical analysis of the Government facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the facility account number, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures. A copy of the report shall be delivered electronically to the Contracting Officer, Lead COR, and each Government facility COR by the 10th of the month following the close of the reporting month. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods: Facility account number Test names listed alphabetically Test names listed in order of year-to-date test frequency (highest to lowest) Test names listed in order of year-to-date total test cost (highest to lowest) Contractor shall provide a monthly listing of any tests that are no longer performed by contractor. This listing shall include, at a minimum, test name and/or test ordering code. Data Management System A. Contractor shall provide to the Government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Government and the Contractor s database. Required test parameters include: Ordering code LOINC code CPT code Interface code Test cost Reference ranges Units of measurement Test result interpretation or interpretive remarks, if appropriate Testing site (if not performed at the vendor s main laboratory facility Test methodology Specimen types Specimen collection and handling requirements Indication whether test is a panel/profile test, list of tests included The parameters for all tests in the Contractor s database shall be kept current and be available to the Government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to Government sites no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor s technical representative to respond to any question(s) regarding the laboratory test parameter information. B. The Contractor shall provide a data management system that meets the following requirements: Test ordering must be 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 must also alert the user to the location of the laboratory that will be performing the test. Test definition, test information and test requirements must be complete, available and easily accessible. 3) Shipping manifest must be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered. 4) The status and the results of testing must be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include: Sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes. 5) Reports of test results must be immediately available upon verification of the test result. Contractor s computer located at the Government site must be able to print test results upon request and reprint retrospective test results. Telecommunication Interface Requirements In order for contract performance to begin within the shortest time possible after contract award, Contractor must already possess a current VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor s host computer system and the Government s host computer system (VistA). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.) The VistA host computer system supports a Universal Interface (UI) and a Generic Instrument Manager (GIM). The GIM is a commercial hardware and software product that provides electronic connection between the Contractor s host computer and the Government s host computer. The configuration must provide the required security of the Government host computer system. The actual electronic connection between the GIM and the Contractor s host system is of the Contractor s choosing. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the Contractor throughout the performance of the contract. Contractor shall provide, install, and if necessary remove, all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to all sites referred to herein. This may include, but is not limited to: 1) Generic Instrument Manager (GIM) for the interface connection Shipping list printers Bar-code printers Back-up result printers connected directly to Contractor s computer system Any required communication lines Software to receive and send orders, display status of and/or test results Consumable supplies to maintain the operation of the equipment listed above, e.g. toner, etc. Contractor shall be responsible for all annual recurring costs associated with support and maintenance of the Generic Instrument Manager (GIM) system including all GIM equipment, software and instrument connections. The Generic Instrument Manager will be located in a Government secured area. The Contractor shall coordinate with the respective Government Information Technology Department to access the GIM. The Contractor shall conduct preventive maintenance and repair of Contractor furnished hardware, software and associated communication lines. In addition, throughout the performance period of the contract, the Contractor shall repair or replace any malfunctioning hardware or software. All electronic messaging between the two (Contractor and Government) host computer systems using the GIM shall utilize VistA Health Level Seven (HL7) V1.6 technical specifications. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc web-site, www.HL7.org. VistA Laboratory Electronic Data Interchange (LEDI) identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. The LEDI specification follows very closely the HL7 V2.3.1 standard. LEDI identifies encoding tables and HL7 message protocol conventions. LEDI also identifies to the commercial reference laboratory contractor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format during the implementation period. This information is also available in electronic HL7 format if required. (LEDI) software will provide a HL7 acknowledgement for the receipt of tests results from the contractor. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy must contain Government s assigned specimen identification where specimen identification is defined as a unique Government-assigned number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest. The Contractor shall provide the Government with specimen status in response to electronic and verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government s assigned specimen identification shall be returned to the requesting medical center. Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain and support the services of the host-to-host linkage between the Government and the Contractor. Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that Government staff is capable of performing routine servicing of hardware. Meeting the below specified deadlines are of utmost importance to the Government. As such, Contractor shall have an operational interface connection with the facilities listed herein within 45 days of contract award. The establishment of the test database will be the responsibility of the Government and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmissions through the interface connection will be the joint responsibility of the Government and Contractor. Test database construction and transmission validation will occur using a phased approach that occurs over the periods of time listed in the table below. Identification of specific test names for each phase will be provided after contract award. Phase List of Test Names Test Transmission Validation Time Periods 1 Test Numbers 1-125 1-90 days after interface connection 2 Test Numbers 126 - 470 91 days - 6 months after interface connection 3 Test Numbers 471 and above As needed through life of contract The Contractor shall certify in writing successful test validation on the final day of the time periods indicated for Phase 1 and Phase 2 listed above. Written certification will not be required for Phase 3, as test establishment and validation will occur on an individual, as needed basis.