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B.3 PERFORMANCE WORK STATEMENT Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Services to VISN ... B.3 PERFORMANCE WORK STATEMENT Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Services to VISN 12 VA described herein. Reference Laboratory Services include but are not limited to specimen preparation and storage; transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing; reporting of analytical test results; and consultative services. I. Specimen Preparation and Storage for Reference Testing Specimens Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. If a 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. D. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. Transportation Services for Reference Testing Specimens Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained. Routine transportation services shall occur once per day from the Government facilities. Specimen pick-up times will be negotiated after contract award. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory. These supplies shall include, but may not be limited to: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Test request forms, preprinted with the appropriate Shipping Section details and account information. Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.). Emergency transportation services shall be available 24 hours per day, seven days per week including Federal holidays. The estimated number of emergency transportations per facility per year is one (1). Response time for emergency transportation services shall be within 4 hours for those Government facilities within the metropolitan Chicago, Milwaukee, and Madison areas and 6 hours for the Tomah and Iron Mountain VA Medical Centers. Emergency response time refers only to the transportation of the specimen(s) and does not include the time for test performance. 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. Contractor shall make available the following test information: Requisition form requirements Alphabetized test name list Test order code Specimen collection and preservation requirements Test method employed (indicate if testing performed in duplicate) and interpretations Test reference intervals adjusted for age, sex, or race, when required Test specific sensitivity, specificity, and interferences, when required Result code Test critical values, if any Policy for critical value notification CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by a Government facility Schedule of test performance (specific days of week indicated) Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited) Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. Additional tests may be added to the contract through modification by the Contracting Officer. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials. 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 testing and diagnostic evaluation shall be returned within 7 days after final diagnosis is reported. Reporting of Results The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information. A report of laboratory testing results must be transmitted as a printed copy to the dedicated printer at the ordering Government facility and when possible, through electronic host to host computer interface. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery via the dedicated printer is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the Telecommunication Requirements below. Each test report generated in hard copy 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 supplied) Government laboratory accession number (if supplied) Submitting facility name Submitting facility account number Patient's location (clinic/ward) (if supplied) Test(s) ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference intervals (adjusted for age, sex or race, when appropriate) Toxic and therapeutic ranges, if applicable Flagged abnormal results Reference laboratory accession number Name and address of testing laboratory Any other information the laboratory has that may indicate a questionable validity of test results. Specimen inadequacy with documentation supporting its unsuitability for testing. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission. Customer Service Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period: 1. Telephone Inquiries Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government s minimum time expectation for meeting this service. Specimen Collection Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call. Testing Inquiries regarding the status of pending orders shall be addressed at the time of the initial call. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call. c. Technical Expertise Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call. Result interpretation inquiries shall be addressed within four business hours of initial call. 3) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call. d. Account follow-up Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods. Consultative Services/Utilization Reports Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation. Contractor shall provide a statistical analysis of the Government facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs. Contractor shall provide monthly a cumulative workload summary report of tests performed. The summary must include the facility account number, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures. A copy of the report shall be delivered electronically to the Contracting Officer, Lead COR, and/or each Government facility COR by the 10th of the month following the close of the reporting month. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods: Facility account number Test names listed alphabetically Test names listed in order of year-to-date test frequency (highest to lowest) Test names listed in order of year-to-date total test cost (highest to lowest) Contractor shall provide a monthly listing of any tests performed not listed in Attachment A. This listing shall include, at a minimum, the test name and/or test ordering code, quantity of each test performed, and the FSS contract pricing or proposed pricing. 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, test name and/or test ordering code. Contractor shall provide a statistical analysis of the Government facilities on Turnaround Time (TAT) studies on selected testing that the VISN has ordered. This includes a breakdown of individual testing ordered with each individual specimen TAT, table with total number ordered, total number of specimens that met TAT, total number of specimens exceeded TAT. Graph of overall data. Data Management System A. Contractor shall provide to the Government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Government and the Contractor s database. Required test parameters include: Ordering code LOINC code CPT code Interface code Test cost Reference ranges Units of measurement Test result interpretation or interpretive remarks, if appropriate Testing site (if not performed at the vendor s main laboratory facility Test methodology Specimen types Specimen collection and handling requirements Indication whether test is a panel/profile test, list of tests included in panel/profile The parameters for all tests in the Contractor s database shall be kept current and be available to the Government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to Government sites no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor s technical representative to respond to any question(s) regarding the laboratory test parameter information. B. The Contractor shall provide a data management system that meets the following requirements: Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test. Test definition, test information and test requirements must be complete, available and easily accessible. 3) Accepts shipping manifests generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered. 4) The status and the results of testing must be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include: Sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes. 5) Reports of test results must be immediately available upon verification of the test result. Contractor s computer located at the Government site must be able to print test results upon request and reprint retrospective test results. Telecommunication Interface Requirements In order for contract performance to begin within the shortest time possible after contract award, Contractor must already possess a current, VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor s host computer system and the Government s host computer system (VistA). The VistA host computer system supports a Universal Interface (UI) and a Generic Instrument Manager (GIM). The GIM is a commercial hardware and software product that provides electronic connection between the Contractor s host computer and the Government s host computer. The configuration must provide the required security of the Government host computer system. The actual electronic connection between the GIM and the Contractor s host system is of the Contractor s choosing. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the Contractor throughout the performance of the contract. Contractor shall provide, install, maintain, repair, and if necessary, remove, all required telecommunication equipment, hardware, software, and related consumable supplies to support the transmission of electronic data to all sites referred to in Section B2. This may include, but is not limited to: 1) Generic Instrument Manager (GIM) for the interface connection Shipping list printers Bar-code printers Back-up result printers connected directly to Contractor s computer system Any required communication lines Software to receive and send orders, display status of and/or test results Consumable supplies to maintain the operation of the equipment listed above, e.g. toner/ink, paper, labels, etc. Contractor shall be responsible for all annual recurring costs associated with support and maintenance of the Generic Instrument Manager (GIM) system including all GIM equipment, software, and instrument connections. The Generic Instrument Manager will be located in a Government secured area. The Contractor shall coordinate with the respective Government Information Technology Department to access the GIM. The Contractor shall conduct preventive maintenance and repair of Contractor furnished hardware, software, and associated communication lines. In addition, throughout the performance period of the contract, the Contractor shall repair or replace any malfunctioning hardware or software. All electronic messaging between the two (Contractor and Government) host computer systems using the GIM shall utilize VistA Health Level Seven (HL7) V1.6 technical specifications. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc website, www.HL7.org. VistA Laboratory Electronic Data Interchange (LEDI) identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. The LEDI specification follows very closely the HL7 V2.3.1 standard. LEDI identifies encoding tables and HL7 message protocol conventions. LEDI also identifies to the commercial reference laboratory contractor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format during the implementation period. This information is also available in electronic HL7 format if required. (LEDI) software will provide a HL7 acknowledgement for the receipt of tests results from the contractor. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy must contain Government s assigned specimen identification where specimen identification is defined as a unique Government-assigned number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest. The Contractor shall provide the Government with specimen status in response to electronic and verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government s assigned specimen identification shall be returned to the requesting medical center. Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain, and support the services of the host-to-host linkage between the Government and the Contractor. Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that Government staff is capable of performing routine servicing of hardware. Period of Performance Base Period: 1 June 2023 through 31 May 2024 Option Period One: 1 June 2024 through 30 November 2024 Option Period Two: 1 December 2024 through 31 May 2025 Places of Performance Jesse Brown VA Medical Center William S. Middleton VA Hospital 820 S. Damen Ave 2500 Overlook Terrace Chicago, IL 60612-3728 Madison, WI 53705-2254 Edward Hines Jr. VA Hospital Clement J. Zablocki VA Medical Center 5000 S. 5th Ave 5000 W. National Ave Hines, IL 60141-1457 Milwaukee, WI 53295-0004 Oscar G. Johnson VA Medical Center Tomah VA Medical Center 325 E. H Street 500 E. Veterans St. Iron Mountain, MI 49801-4760 Tomah, WI 54660-3105 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. 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 contract, the Contractor is certifying that all persons performing services under the contract have been compared against the OIG list and are NOT listed as of the date the contract was signed. Record Keeping Contractor Contractor must establish a record keeping system of all tests performed per regulatory guidelines. 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 Department of Veterans Affairs. The VA 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. 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 VA facilities are a hospital setting, they are 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. Designation of Contracting Officer Representative (COR) The VISN12 Pathology & Laboratory Medicine Services (PaLMS) Business 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. Contract Performance Monitoring A. For specimen pickup, contractor employees shall report to the Laboratory for specimen pickup. B. Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. The COR will be responsible for verifying contract compliance and may designate other VISN12 personnel to monitor services through one or a combination of the following mechanisms: 1) Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer. 2) Documentation of services performed will be reviewed prior to certifying payment. VISN12 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. 3) Facilities being served, through the COR, will provide a written statement 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 the base and each option period. 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 VISN12 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 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 VISN12 COR. D. Quality factors that VISN12 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 TASK PERFORMANCESTANDARD ACCEPTABLE (MINIMAL) QUALITY LEVEL (AQL) AQL s of 100% are based on the fact that all circumstances outside of the contractor s control have been accounted for in the performance work statement. For instance, loss or destruction of specimens and missed routes are justified in the case of force majeure events and therefore are not included in determining the contractor s acceptable quality level of performance. If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer and the VISN 12 Lead COR. 2 The disincentives above are based on VA s internal costs incurred when certain performance requirements are not met. Lost or destroyed specimens will require additional medical procedures and delayed health care, the costs of which exceed the disincentive amount. MONITORINGMETHOD DISINCENTIVES Ensure the safety and integrity of specimens No loss or destruction of specimens IAW PWS B3.II.A 100% of the time Contractor reporting; Government inquiries. $100 may be deducted for each specimen that is lost or destroyed. Testing services will be performed in accordance with the defined turnaround times (TAT) Results will be reported within the TAT listed in the contractor s laboratory reference test manual per test IAW PWS B3.V.A 90% of the time. 100% inspection of 6 of the 125 highest volume test codes randomly selected per quarter 5% of the cost of each test result reported late may be deducted from the monthly invoice. Emergency Response Time is within the required timeframes Contractor responds within 4 hours for those Government facilities within the metropolitan Chicago, Milwaukee, and Madison areas and 6 hours for the Tomah and Iron Mountain VA Medical Centers IAW PWS B3.II.D 100% of the time 100% Direct Observation $100 may be deducted from the invoice for not responding within the required timeframes. Required Registration with Contractor Performance Assessment System Reporting System (CPARS) A. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, VISN 12 evaluates contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VISN 12 uses an online database, the Contractor Performance Assessment Reporting System (CPARS). B. Each contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the contracting officer contact information for the contractor s representative with their response to the solicitation. The contractor is responsible to notify the contracting officer of any change to the contractor s representative during the contract performance period. Contractor s representative contact information consists of a name and email address. The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor s designated representative for comment. The contractor s representative will have thirty days to submit any comments and return the report to the VA contracting officer. Failure by the contractor to respond within those thirty days will result in the Government s evaluation being placed on file in CPARS without contractor s comments.