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Draft - abbreviated Page 22 of 32 B.3 PERFORMANCE WORK STATEMENT Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Refe... Draft - abbreviated Page 22 of 32 B.3 PERFORMANCE WORK STATEMENT Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Testing Services to FHCC as described herein. Reference Laboratory Services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens and microbiology cultures to the testing laboratories; performance of analytical testing as defined by the Contractor s reference test manual; the reporting of analytical test results within the required timeframes defined by the FHCC; specimen processors, and consultative services as required. I. Specimen Preparation and Storage Contractor shall supply each Government facility with its commercial laboratory reference test manual (either hard copy or electronic) to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. The FHCC will provide laboratory specimens properly prepared, identified and labeled for testing. B. Contractor shall provide at no additional charge an adequate supply of specimen collection materials necessary to collect and preserve specimens that are destined to the testing laboratories. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory such as dry ice, stabilizing tablets, ice packets, etc. Contractor will be responsible for storing specimens in such a manner to ensure no loss of specimen or the integrity of the specimen during transport. C. Contractor may also be requested to assist with specimen preparation (special staining) for histopathology and surgical pathology requirements. D. The Contractor shall store the specimens a minimum of three days after the test result is reported in the event that subsequent action is necessitated (i.e. problem solving and/or repeat testing). E. If a medico 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. Transportation Services Contractor shall provide reference laboratory testing courier services of primarily biomedical materials including patient specimens and microbiology cultures originating from the FHCC and destined to the contracted commercial reference laboratories. 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 materials are maintained. Routine transportation services shall occur once per day from the Government facilities listed in Section B2. Specimen pick-up times will be mutually agreed upon between the FHCC and the contractor after contract award. The contracted commercial reference laboratory shall be responsible for complying with the most current version of the accreditation standards as it relates to the transport of specimens to ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging and environmental control procedures suitable to specimen type and distances transported. This also includes issues such as adherences to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. During the term of this contract, this contractor program may need to be updated or revised to comply with regulatory requirements. This documentation should be made available to the FHCC upon their request. Contractor shall provide, at no additional cost, all necessary supplies for biomedical materials necessary to distribute, transport, and deliver specimens from the FHCC to the testing laboratories. These supplies shall include, but are not be limited to: Shipping and packaging containers and/or bags. Packing material must be capable of maintaining temperature requirements for specimens until they reach the testing laboratories. Required labels/stickers and packaging materials for shipping specimens via courier for testing, which 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. Preprinted test request forms with the appropriate Shipping Section details and account information. Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.). E. Upon each pick-up or delivery of testing specimens by the contractor, a shipping manifest shall be provided detailing specimen identification, source and destination information. In addition, it shall be the responsibility of the contractor to ensure that its or any subcontracted transport personnel shall comply with all policies and procedures for tracking specimens. Site-specific handling procedures will be mutually agreed upon between the FHCC and the contractor and will include, but is not limited to, documentation of dispatch and receipt of specimens, condition of specimens upon receipt, etc. F. Emergency transportation services shall be equal in quality to the routine transportation services provided, and be available 24 hours per day, seven days per week including federal holidays. The estimated number of emergency transportation services per year is one. Specimen pick-up response times for emergency transportation service requests shall be within 4 hours. 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 tests as annotated in Attachment A (approximately 735 tests). Contractor shall make available the test information below and notify the FHCC when any modifications to this information occur during the contract period. Requisition form requirements Alphabetized test name list Contractor 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 for test Contractor test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by the FHCC. Schedule of test performance (specific days of week/frequency 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) B. Contractor shall provide accurate, timely, and appropriate testing of patient specimens as requested by the FHCC. For most tests, the required test result turnaround time (TAT), is within 24 hours following specimen pick up either by hard copy or electronic report transmission. It is recognized that certain test procedures will require a longer turnaround time than the 24 hours. Under these circumstances, test results shall be delivered no later than 1 hour after the verification of the test result. C. The FHCC has identified several tests that require strict compliance to different, faster TAT timeframes when sent from the FHCC Red Rover Laboratory. These tests and applicable TATs are identified below. Test Name Required Turnaround Time Hepatitis A Ab Total Next business day from collection date by 1330 Hepatitis B Surface Ab QN Next business day from collection date by 1330 Measles (Rubeola) IGG Next business day from collection date by 1330 Rubella IGG Next business day from collection date by 1330 Varicella IGG Next business day from collection date by 1330 Mumps IGG Next business day from collection date by 1330 Sickle Cell Screen Next business day from collection date by 1330 Hemoglobin & Hematocrit Next business day from collection date by 1300 G6PD Deficiency Screen Next business day from collection date by 1330 Fasting Glucose Next business day from collection date by 1330 B-HCG Quantitative Next business day from collection date by 1330 ABO and Rh Next business day from collection date by 1330 Hemoglobin A1C Next business day from collection date by 1330 Syphilis Antibody Cascading Reflex Two business days from collection date by 1330 Gonorrhea PCR Two business days from collection date by 1330 Chlamydia PCR Two business days from collection date by 1330 Urinalysis Two business days from collection date by 1330 Urinalysis Microscopic Two business days from collection date by 1330 Hemoglobinopathy Two business days from collection date by 1330 Tuberculosis Test (must be 1 tube method) Two business days from collection date by 1330 D. The FHCC has identified several tests that require strict compliance to different, faster TAT timeframes when sent from the FHCC Main Laboratory. These tests and applicable TATs are identified below. Immunohistochemistry and Special Stains (Anatomic pathology) Not to exceed 3 business days from pick-up date and delivery date. Must be notified of all delays. Paps and HPVs Not to exceed 5 business days from pick-up date. Must be notified of all delays. Urine Cultures Not to exceed 3 business days from pick-up date and delivery date. Must be notified of all delays. E. 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. F. Contractor shall notify the COR and FHCC Laboratory personnel of any test information/methodology changes no later than two weeks prior to the implementation date of the test change. If any of these changes affect availability (i.e. discontinued) of the test, price or other information on Attachment A, the Contracting Officer shall also be notified. These changes shall be reflected via contract modification. Any increases in test price must be negotiated and/or approved by the Contracting Officer via contract modification. IV. Specimen Retention A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA and sent to the Contractor laboratory for staining, testing and diagnostic evaluation shall be returned within 5 days after final diagnosis is reported. Slides and blocks sent for immunohistochemistry and special stains should be sent back the same day as the stained slides. V. Reporting of Test Results The primary transmission of laboratory test results shall be through electronic host to host computer interface. Laboratory test results that are not interfaced must be immediately available through the Contractor s electronic web-based portal that the Government facility has access to. In unusual circumstances where electronic delivery either via interface or web-portal 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 FHCC. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited. Additionally, any test result that includes a pathologist interpretation must be transmitted to a dedicated fax machine at the ordering FHCC facility and when possible, available electronically via an online portal. Specifications outlining the requirements of the computer system interfaces including computer hardware, maintenance and supply requirements are defined in Section B3.X., Telecommunication Requirements below. Each test report generated in printed form or through electronic transmission 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 provided) FHCC medical record number or laboratory accession number (if provided) FHCC ordering facility name FHCC Account number 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 umber Name and address of testing laboratory Any other information the laboratory has that may indicate a questionable validity of test results. Specimen inadequacy (if applicable) with documentation to support its unsuitability for testing. Test results determined by the contractor to be a critical value, as well as test results determined by the Illinois Department of Public Health to be Reportable Diseases, shall be communicated by telephone to a designated FHCC 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 report transmission. Contractor shall provide a daily report by 1:00 p.m. listing all incomplete specimens and canceled tests from the Red Rover account. VI. Specimen Processors Contractor shall provide two (2) full-time equivalent Specimen Processing Technicians to the FHCC (one assigned to Red Rover and one assigned to the Main Campus) laboratories to assist with the processing of specimens, e.g. centrifuging, packaging, shipping, ordering, etc. The technician shall also be responsible for retrieving laboratory results, obtaining test information, contacting customer service to obtain results and resolve inquiries, running and reconciling incomplete test lists. Specimen processors will not have access to any FHCC computer systems. The specimen processing technicians will work Monday through Friday, excluding federal holidaysfrom 6:00 a.m. 2:30 p.m. for Red Rover Laboratory and 7:00 a.m. 3:30 p.m. for the Main Campus Laboratory. Lunch breaks will be a half-hour in duration. No overtime is anticipated or approved under this contract. B. Contractor shall provide enough back-up personnel to perform services during absences of the primary Specimen Processing Technicians for any reason. Contractor shall also provide for the permanent replacement of a primary Specimen Processing Technicians, if necessary. D. The Government will provide a work area to be used for administrative functions by the Contractor s employees (Specimen Processing Technicians). E. All contract employees performing work on a government facility shall observe and comply with all local rules and regulations prescribed by the installation and other federal authorities concerning fire, safety, sanitation, security and possession of firearms or other lethal weapons. No contract employee will be permitted on the installation when his/her presence could be detrimental to the security of the installation or safety to themselves. Specimen processors working on-site at the FHCC shall be subject to an ANACI background investigation. F. Contractor shall obtain all local, state and federal government licenses, passes and permits necessary to enter the government installation, to include motor vehicle registration and insurance, as required by the FHCC. VII. Customer Service Contractor shall provide toll-free telephonic customer service 24 hours per day, 7 days per week to assist Government staff with tracking and resolving related issues/problems that may arise in the performance under this contract. Upon award, contractor shall assign a local area account representative and alternate representative to provide direct and on-site support for each of the FHCC facilities. Contractor shall provide the name(s) and telephone number(s) of these representatives and other 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 ½ hour of the initial call. Testing Inquiries regarding the status of pending results 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 business 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. VIII. Consultative Services/Reports Contractor shall provide 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. Upon request, contractor shall provide a statistical analysis of the FHCC facility s workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the FHCC on mechanisms to reduce its costs. C. The following reports may be requested by FHCC and shall be delivered to the FHCC by the 20th of the month following the close of the reporting month: 1) A monthly cumulative summary alphabetically by patient indicating patient s name, test ordered, date specimen received and ordering physician. 2) A monthly summary sheet by test frequency for each FHCC Laboratory listing patient name, volume of tests ordered, unit charge, total charges for this month and year to date. 3) A summary sheet listing the type and volume of testing sent to a subcontracted reference laboratory. 4) A monthly summary sheet by dollar volume 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. 5) A utilization summary sheet by test frequency of both FHCC Laboratories listing all tests ordered, the volume of tests ordered, unit charge per tests, total charges and percent abnormal results for the period. 6) A monthly summary sheet of all telephone notifications of specimens cancelled because of unacceptability, i.e. volume, specimen container, identification, loss of specimen, etc. D. Contractor shall provide a cumulative workload summary report of tests performed on a monthly basis. 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 and COR by the 20th of the month following the close of the reporting month. E. All reports shall be submitted in an electronic spreadsheet format and have the capability to sort by four (4) different methods: 1) Facility account number 2) Test names listed alphabetically 3) Test names listed in order of year-to-date test frequency (highest to lowest) 4) Test names listed in order of year-to-date total test cost (highest to lowest) G. The Contractor shall provide, a daily cumulative report retrievable by collection date(s) that details patient identifying demographics and the associated test results for the Red Rover Laboratory as identified in B.3.III.C. Designated government contact personnel must be notified when it s available. The daily report shall be available prior to the turnaround time deadline. IX. Data Management System A. Contractor shall provide to the FHCC all necessary laboratory test parameters (parameters are required for each test contained in a panel) to ensure accurate test result transmission between the FHCC s and the Contractor s databases. Required test parameters are listed below. Ordering code Logical Observations Identifiers Names and Codes (LOINC) code CPT code(s) Interface code Test cost Reference ranges Units of measurement Test result interpretation or interpretive remarks, if appropriate Testing site (if not performed at the contractor 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 in panel/profile If test is a panel or profile test, list the tests included (NOTE: the above parameters are required for each test contained in a panel). The parameters for all tests in the contractor s database shall be kept current and be available to the FHCC throughout the performance period of the contract. Updates to test parameter information must be provided to FHCC no less than 2 weeks prior to the implementation of any changes in the following situations: when new tests are developed and introduced into the contractor s test menu, testing parameters have changes or when tests are discontinued or replaced by other tests. The Contractor shall provide telephone access to a 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) Accepts FHCC generated shipping manifests that identify specimens sent to the contractor s testing laboratories, transportation conditions, and testing ordered. 4) The status and the results of testing must be available within published timeframes and easily retrievable by various methodologies. At a minimum, these options must include sort by patient name; sort by date; sort by test; and sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notifications, must be generated when testing is delayed beyond required and/or published timeframes. 5) FHCC must be able to print test results from the contractor s web-based portal as well as reprint previous test results. Telecommunication Interface Requirements A. The contractor shall provide an integrated system approach to facilitate and streamline all aspects of specimen testing. All reasonable effort shall be made to improve services, reduce cost to the FHCC, and implement methods that reduce or eliminate manual procedural steps such as bar-coding and specimen labeling. The contractor shall also provide a bi-directional interface system to electronically transmit orders, specimen status and test results between its computer system and the two computer systems at the FHCC (VA VistA and DoD CHCS). All test panels and individual tests must be mapped in both the VistA and CHCS systems. As such, this contract will require an approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) for interface with VistA, as well as laboratory interoperability with the CHCS laboratory information system through an approved DoD methodology on a Military Health Systems Medical network. B. Contractor shall provide, install, maintain, repair, and remove if necessary, all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to the FHCC Laboratories. This may include, but is not limited to: 1) Generic Instrument Manager (GIM) for host to host connectivity 2) Any required lease communication lines 3) Software to receive and send orders, status and test results 4) Shipping list printers 5) Back-up result printers connected directly to Vendor s computer system 6) 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 programming, support and maintenance of any GIM system(s) including all GIM equipment, software and instrument connections, and the expense of the electronic message connectivity during performance of the contract. The GIM(s) will be located in a FHCC secured area. The vendor shall have access to the GIM(s) during normal FHCC business hours if prior arrangements have been made, unless special circumstances exist. Contractor shall coordinate with the respective FHCC Information Technology Department for access to the GIM(s). F. Contractor shall provide FHCC with specimen status in response to electronic and verbal queries. Upon testing completion, a formatted Health Level 7 (HL7) message containing specimen results with FHCC s assigned specimen identification shall be returned to the requesting FHCC Laboratory. All electronic messaging between the contractor and FHCC host computer systems using a GIM shall utilize VistA Health Level Seven (HL7) technical specifications or any later version, and CHCS. HL7 is a registered trademark of Health Level Seven, Inc, and is 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. G. In the event that electronic communication is disrupted, the vendor shall provide hard copy of specimen results upon demand. The hard copy must contain FHCC s assigned unique identification number that is associated with each individual specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest. H. 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 FHCC and the Contractor. I.   Interface with VistA (Veterans Integrated System Technology Architecture) or current system (VA tentatively is looking to roll out and have a new system completed by 2022): This connection is required for all samples sent from the FHCC Main Campus Laboratory. 1) 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 FHCC s host computer system, VistA. To do this, it is preferred the contractor have a current VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU); but the agreements and memorandums identified above may also be established directly with the FHCC. These typically take 30 to 45 days to establish. 2) VistA supports the Universal Interface (UI) and the GIM. The GIM is a commercial hardware and software product that provides electronic connection between instruments and the VistA host computer, as well as connectivity between the VistA computer host and the contractor s host computer. VistA provides a single serial communication line to the GIM for passing electronic data. This configuration provides the required security of the FHCC VistA host computer system. The actual electronic connection between the GIM and the contractor s host system is of the contractor s choosing. If contractor utilizes a third-party instrument manager system to handle HL7 order and result messages between the contractor s host computer system and VistA, then the contractor will be responsible to initially add all applicable test codes and names of the top 125 most frequently ordered tests. 3) The transmission protocol shall conform to current VistA Health Level Seven (HL7) and Laboratory s HL7 technical specifications. VistA Laboratory Electronic Data Interchange (LEDI) will provide technical specification for message format, content and encoding tables and HL7 message protocol conventions. The LEDI specification follows very closely to the current HL7 standards. The LEDI specification can be negotiated at the technical level only. 4) VistA LEDI will provide to the contractor shipping lists containing required specimen demographics and requested tests to be performed. This information will be provided in printed format during the implementation period and is also available in electronic HL7 format if required. If the contractor requires of the FHCC any specific software to implement the electronic interface, these requirements must be specified in the offer to the Government. VistA LEDI software will also provide a HL7 acknowledgement for the receipt of tests results from the contractor. J. Interface with CHCS (Composite Health Care System): This connection is required for all samples that are sent from Red Rover Laboratory and Fisher Laboratory. 1) 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 FHCC s host computer system, CHCS.  To do this, it is preferred the contractor have a current Authority to Operate (ATO) Certification from the Department of Defense (DoD) or past experience with connection to DoD information systems, but new ATO Certifications may be established. 2) Contractor shall follow the DoD Instruction (DoDI) 8510.01 Risk Management Framework (RMF) for DoD Information Technology (IT) to ensure its system will achieve and maintain adequate security for all unclassified DoD information on non-DoD Information Systems (IS), and work with FHCC COR in coordination with the FHCC/DoD RMF and IS/IT teams to ensure this requirement is met. The Contractor shall coordinate with the Government to ensure that the appropriate security and privacy controls have been identified. Contractor will address how applicable safeguards will be implemented prior to commenceme...