Q301--Reference Lab Testing Bridge - 556
VA69D-16-D-0087 Page 32 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 tee 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. G. Addressing courier service issues and problems. A direct contact individual(s) shall be designated for immediate response to courier service issues. This contact individual(s) shall be available for emergency response within the timeframes covered in the agreed upon courier route plan and toughout extended time periods when the courier is not able to meet the agreed upon delivery times. The contact information, i.e. name(s) and telephone number(s), for these services shall be available after award. 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. G. Any new test(s) not listed in Attachment A must be added to the contract tough modification by the Contracting Officer (the COR and FHCC Laboratory personnel do not have this authority) prior to specimen being tested. If a test is not listed on Attachment A, it must be billed under a non-contracted account number. IV. Specimen Retention A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or tough 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 tough electronic host to host computer interface. Laboratory test results that are not interfaced must be immediately available tough 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 tough 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 tough Friday, excluding federal holidays from 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. C. The Contractor shall provide a full initial comprehensive orientation and training of all Specimen Processing Technicians who will work at the FHCC Main Laboratory and Red Rover. This training will encompass all policies, procedures, and software related to services provided by the contractor and utilized by the FHCC. However, in the event of a change to the procedures, method, regulation, etc., on the part of either the Government or the Contractor occurring after the initial implementation period, a mutual exchange of training/information shall be accomplished. All on-site contractor personnel must complete all security requirements prior to providing services under this contract. 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. G. The Government reserves the right to require removal from the job site any contract employee who endangers persons or property and whose continued employment is inconsistent with the interest of government security. In such cases, the Contracting Officer or COR will advise the Contractor of the reason for requesting an employee s removal or withdrawing their permit to enter the installation. H. The Contractor shall remove from duty any contractor employee found to be incapacitated or under the influence of alcohol or drugs, or other incapacitating agents and shall not return such an employee to duty until such employee is fully able to perform the normally assigned duties. Removal of employee(s) for such causes does not relieve the Contractor of the requirement to provide sufficient personnel to adequately perform services specified under this contract. I. Neither the Contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations. J. Neither the Contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the FHCC. Results shall be handled as private medical records in accordance with Privacy Act Requirements for Medical Records Systems. K. All inquiries, comments or complaints pertaining to patient information or government information, arising from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution. 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 toughout 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 A 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. The Government will notify contractor of the need for additional specimen collection and transportation supplies by telephone or tough written or electronic methods. Contractor shall conduct timely interface testing when there is a change in test reporting and codes. 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) F. Contractor shall provide a monthly listing of any tests listed in Attachment A that are no longer performed by contractor and shall be removed from Attachment A. This listing shall include, at a minimum, contractor test name and test ordering code. 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 toughout 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 tough 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. C. A test catalog shall be published on an annual basis and made available to the FHCC. Addendums/updates to the test catalog shall be made available (either electronically or in hard copy) to the FHCC. The test catalog shall include all test information as required by regulatory requirements. A reference guide to test interpretation shall also be available. 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 tough 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). Contractor is responsible for the preventive maintenance and repair of Contractor furnished hardware, software and associated communication lines. In addition, toughout the performance period of the contract, the Contractor shall repair or replace any malfunctioning hardware or software at no additional cost to the Government. E. 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 FHCC can perform routine servicing of hardware. 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 tough 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. A A Interface with VistA (Veterans Integrated System Technology Architecture) or current system (VA is proceeding with the roll out of a new system (Cerner) at FHCC and expects it to be completed by 2024): 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.A 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 add all applicable test codes and names. 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) (DoD is proceeding with the roll out of a new system (Cerner) and expects it to be completed by 2024):A 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.A A 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 commencement of full performance. 3) Contractor shall ensure all necessary preparations, including ability to electronically transfer data correctly, are performed for full contract services prior to contract performance/effective date. Upon award of contract, the contractor will have ninety (90) calendar days to achieve full testing performance of the top 125 highest volume tests. Failure to achieve an ATO Certification, at least on a conditional basis, within ninety (90) calendar days of contract award during the ramp-up period may be considered non-fulfillment of the contract. Contractor shall ensure the following tasks identified in the ramp-up period are performed: a) An ATO process kick-off shall be initiated between the Contractor, FHCC COR and DoD RMF Assigned Team. Contractor shall contact the DoD RMF Office Representative and FHCC COR, no later than five (5) business days after contract award to start the process. Failure to do so would be considered a contractor-caused delay. Thereafter, the contractor must attend a monthly teleconference to discuss and provide a progress report on/around the 5th of each month, between the FHCC COR, RMF Team, and the Contractor. The report and discussion will include progress and issues on the efforts to achieve the required electronic interface in accordance with DoDI 8510.01. Teleconferences shall continue until the interface is complete. b) Contract personnel needing privileged-level account for administrative/maintenance support of systems/applications on the network, will meet DoD requirements for a privileged-level account before being provided access to DoD systems (see B.5.XVI). Contractors must also undergo a successful security screening and background investigation prior to access being granted. K. Cerner transition will happen during the period of performance of this contract. The transition will be handled tough a modification. Awardee must be willing and capable to transition to Cerner. Cerner is a joint VA and DoD Electronic Medical Record (EMR/EHR) System. Specific specifications of that system will be identified in the modification and a request for equitable adjustment will be entertained at that time. Cerner will still require a B2B connection for both the DoD and VA. Awardee will need to establish the test data bases and have the ability to fully operate on Cerner once transition is complete. For more information regarding Cerner, please see Addendum A. XI. Test Database Build & Validation A. Establishing the test databases and validation process are significant task in the performance of the contract. Meeting the below specified deadlines are of utmost importance to the FHCC. As such, Contractor shall have operational interface connections with the FHCC Main Campus Laboratory within 45 days after contract award and with the FHCC Red Rover and Fisher Laboratories within 90 days after contract award. The establishment of the test database will be the responsibility of the FHCC and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of electronic transmission of orders to the contractor and receipt of electronic result messages from the contractor to VistA and CHCS systems tough the interface will be the joint responsibility of the FHCC and Contractor. B. Test database construction and transmission validation will occur using a phased approach that occurs over the periods of time listed in the table below. Regular laboratory testing services of the top 125 highest volume tests under this contract must begin no later than ninety (90) calendar days after contract award Identification of specific test names for each phase will be provided after contract award. Phase Top # of Tests w/Highest Volumes Test Transmission Validation Time Periods After Interface Connection 1 1-125 1-90 days after interface connection 2 126 475 91 days 180 days after interface connection 3 476 and above As needed tough life of contract C. The Contractor shall certify in writing successful test validation by 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. B.4 SPECIAL CONTRACT REQUIREMENTS Services The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c) Changes) and, prior to becoming effective, must be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The Government will not sign any separate agreements from the contractor for equipment, web-tools, or specimen processors that will be utilized in the performance of this contract. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor s employees. Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. Personnel who furnish services under this contract are subject to Government technical oversight of the services rendered. The Government retains the right to reject services for contractual non-performance. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract. Contractor shall not, under any circumstances, furnish laboratory reports directly to patients. II. Period of Performance Base Period: 10/1/2023 3/31/2024 Option One: 4/1/2024 9/30/2024 III. Federal Holidays While not generally required to provide transportation of specimens and specimen processors on federal holidays there is a possibility that these services could be required. IV. Qualifications/Requirements of Laboratory & Contractor Personnel A. Laboratory 1) The contractor must be actively engaged in providing the specific services and laboratory testing identified herein. Contractor must have at least tee years of experience in providing laboratory testing services and must have at least one-year experience in transporting biomedical materials. 2) Offerors, including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The testing laboratories must maintain valid certifications during the entire performance period of this contract. 3) Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending toughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the CO and COR. The above documents must also be supplied for each testing laboratory that is a subcontractor of the primary contractor. 4) Contractor must notify immediately the COR in writing, upon its/any subcontractor s loss of any required certification, accreditation or licensure. Contractor 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. The Government reserves the right to physically inspect the testing laboratories prior to a contract award and at any time during the contract period to ensure the testing laboratory s compliance with accreditation and quality assurance practices and requirements. The Government will not be liable for any expenses incurred by the contractor as a result of these inspections. B. Personnel 1) Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations. 2) Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402). Contractor shall comply with any new regulatory requirements for mandatory education and/or competency assessment, which occur during the contract period. These items must be completed by the individual contractor employee(s) within a mutually agreed upon timeframe between the FHCC and the Contractor. Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor s company. In addition, all contractor representatives shall prominently display a contractor-issued identification badge. HHS/OIG To ensure that the individuals providing services under the Contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (https://exclusions.oig.hhs.gov/) for each person providing services under this contract. Any healthcare provider or entity that employs or enters into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing the proposal, the Contractor is certifying that all persons listed in the contractor s proposal have been compared against the OIG list and are NOT listed as of the date the proposal was signed. II. Record Keeping Contractor Contractor must establish a record keeping system of all tests performed per regulatory guidelines. III. Medical Records Clinical or other medical records (i.e. test results) of FHCC veteran patients treated by Contractor under this contract are owned by the FHCC. If requested, test results will be mailed to the FHCC at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received. IV. Confidentiality of Patient Records A. The Contractor is a FHCC contractor and will assist in the provision of health care to patients seeking such care from or tough FHCC. As such, the Contractor is considered as being part of the department health care activity. Contractor is considered to be a FHCC contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of FHCC records access and patient confidentiality, Contractor is considered to be a FHCC contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, contractor may have access, as would other appropriate components of FHCC, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the department, and not withstanding any other provisions of the contract, the contractor is restricted from making disclosures of FHCC records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from FHCC has been received or disclosure is required by law. The contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as FHCC. B. The records referred to above shall be and remain the property of FHCC and shall not be removed or transferred from FHCC except in accordance with 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or its designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to FHCC s records, at FHCC s place of business on request during normal business hours, to inspect and review and make copies of such records. V. HIPAA Compliance Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the FHCC. The FHCC has recognized Diagnostic Laboratory Testing Facilities as healthcare providers, and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Testing Services. VI. Regulatory Standard All work under this contract shall be performed in accordance with all regulatory requirements for laboratory services such as those set forth by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as well as all other applicable laws and regulations. As the FHCC is a hospital setting, it is subject to inspections and accreditation by The Joint Commission. Contractor shall be aware of all laboratory standards required by The Joint Commission and, in the absence of a contradictory standard from another entity such as CLIA, all work under this contract shall be performed in accordance with those standards. A copy of these standards may be obtained from The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181. VII. Designation of Contract Representative The FHCC Pathology & Laboratory Medicine Services (PaLMS) Regional Manager will be designated as the COR to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The COR will provide technical guidance, verify services were actually performed, and also verify that documentation for services performed is received prior to certifying payment. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of the COR designation are provided in the COR Delegation Memo. VIII. Contract Performance Monitoring A. For specimen pickup, contract employees shall report to the Laboratory Central Processing area, upon arrival at the Main Campus or Branch Clinics for specimen pickup. B. Monitoring of contractor s performance shall be demonstrated tough clinical and administrative record reviews. The COR will be responsible for verifying contract compliance and may designate other FHCC personnel to monitor services tough one or a combination of the following mechanisms: Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by FHCC in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer. Documentation of services performed will be reviewed prior to certifying payment. FHCC will pay only for services provided, and in strict accordance with the Price Schedule/Attachment A. Contract monitoring and recordkeeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided. The COR must provide written approval for payment of all invoices. Departments being served, tough the COR, will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation should be submitted 45 days prior to end of completion of a one-year period (annually), or any option period. C. Contractor s employees may not review/certify invoices for payment. IX. Quality Assurance Monitoring A. Contractor shall maintain a Quality Assurance Program related to the Reference Laboratory Testing Services covered under this contract. B. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the FHCC Laboratories. This program must 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. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe 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. The contractor will meet or communicate with the facility/FHCC staff for process review and improvement of contract performance on an as needed basis. C. Copies of licensure/certifications are also required to be submitted upon request by the FHCC. D. Quality factors that FHCC may consider when monitoring quality of care may include, but are not limited to, patient medical records, security/privacy, adverse event reporting (such as missing or losing a specimen), turnaround times, timeliness to customer service requests, missed/delayed routes, emergency pick-up response times, etc. E. These monitoring procedures and disincentives for contractor s failure in meeting these tasks are further illustrated in the Performance Requirements Summary Matrix below. PERFORMANCE OBJECTIVE TASKS PERFORMANCE STANDARD ACCEPTABLE (MINIMAL) QUALITY LEVEL (AQL) MONITORING METHOD/ FREQUENCY Ensure the safety and integrity of specimens No loss of specimen or specimen integrity IAW PWS B.3.I.B. 98% of the time Contractor reporting; Government inquiries. Testing services will be performed in accordance with the defined turnaround times (TAT) Results will be reported within 24 hours of specimen pickup, or within the 1 hour after test result verification IAW PWS B.3.III.B. 95% of the time. 100% inspection of 6 of the 125 highest volume test codes randomly selected per quarter Results will be reported within the TAT listed in that Table at PWS B.3.III.C. and B.3.III.D. 98% of the time. Contractor reporting; Government inquiries. Emergency Response Pick-up Time is within the required timeframes Contractor responds within 4 hours after request for pickup IAW PWS B.3.II.F. 98% of the time Direct Observation X. Prohibition of Contract Performance Outside of the United States The entire performance of the contract shall be within the borders of the United States of America, the District of Columbia and/or Puerto Rico. The Contractor shall not access any FHCC data/information (for example, by remote computer access) from locations that are outside the above-stated borders. Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any FHCC data/information to locations outside the above-stated borders. XI. Contractor Certification A. Citizenship-Related requirements: The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1965, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S. Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to the FHCC patient referrals. B. While performing services for the FHCC, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all E-Verify requirements consistent with Executive Order 12989 and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations. C. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the FHCC may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S. Department of Labor, shall be prohibited from working at the Contractor s place of business that services FHCC patient referrals; or other place where the Contractor provides services to veterans who have been referred by the FHCC; and shall form the basis for termination of this contract for breach. D. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001. E. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document. 36C25223Q0965 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12
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