VISN1 Reference Lab Testing Services
Added: Dec 13, 2016 11:46 am Department of Veterans Affairs Veterans Health Administration Sources Sought Notice VISN1 Reference Laboratory Services This is a Sources Sought Notice and not a request for quote. This request is solely for the purpose of conducting market research to enhance VHA s understanding of potential sources and their capabilities to provide these services. The Government will not pay any costs for responses submitted in response to this Sources Sought Notice. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products/services in response to the requirement described below. Vendors are invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking a vendor to provide Reference Laboratory Services for the VISN1 VA New England Healthcare System (VANEHS) as further described below. Services are required to obtain professional and technical personnel, materials, equipment, supplies, facilities, specimen transport, tools, information technology, materials, qualified supervision, and other items and services necessary to perform specimen collection and laboratory testing. Testing shall not be limited to items listed in the test menu as technologies are constantly changing and improving. This requirement shall include CPT codes 8000-9000 and generic codes for newly implemented tests. Refer to the General Requirements section below for the requested service description. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy. General Requirements: 1. The Contractor Laboratory shall provide the following services: Transportation of clinical laboratory specimens, originating from the VANEHS Medical Centers and satellite outpatient clinic laboratories (SOC) destined to the contracted commercial reference laboratory. IntraVISN transportation of clinical laboratory specimens originating from the VANEHS Medical Centers and satellite outpatient clinic laboratories (SOC) destined to VA West Roxbury or VA West Haven. Performance of analytical testing. Reporting of analytical test results. Consultative services. Patient Service Centers within VANEHS area for phlebotomy services Laboratory Information System (LIS) Interface with VA s VistA System. Integrated electronic directory of services 2. Tests shall be performed and tested entirely upon the premises of the Contractor, or within the Contractor's network of laboratories, or subcontracted to a fully qualified laboratory. The services shall be provided in a state-of-the-art civilian medical laboratory facility. Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Once a particular test is designated for performance by a particular subcontractor, then all future test performance of that test method shall be done by the same subcontractor unless concurrence to change is received, in writing, from the Government. 3. The Contractor shall provide an all-inclusive test menu including subcontractors testing under the Performance Work Statement FSS/Open Market shall be delineated for each test listed. Tests and the volumes are subject to change based on fluctuating medical need. CPT codes 8000-9000 shall be included as well as generic codes when new tests are implemented. 4. The Contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations concerning specimen testing, and program management. a. Licensing and accreditation Contracting Laboratory, including subcontractors shall: Have all licenses, permits, accreditation certificates required by Federal law and State law. Be accredited by the CLIA or the College of American Pathologists. Copies of all certifications and renewal certifications shall be provided upon submission of a proposal to the Contracting Officer. Have a Medical Director with suitable qualifications and experience to direct a laboratory providing consultation services according to CLIA and CAP standards. Be eligible to provide these services and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this requirement shall be full and unrestricted licenses. Contractor personnel assigned by the Contractor to complete this work shall be licensed by the governing or cognizant licensing board. Comply with the regulatory requirements of Centers for Medicare & Medicaid Services. Notify the Contracting Officer immediately, in writing, upon its loss (by any of its subcontractors) of any required certification, accreditation, or licensure. Submit a copy of the professional certification and/or licensure of the Laboratory Director and/or Medical Director to the Contracting Officer with proposal. 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. Description of Test Information 5. The contractor shall make available either tough its electronic catalog or upon request the following information: Requisition form requirements Alphabetized test name list Reference lab test number/Test order code Specimen collection and preservation requirements Test method used (indicate if testing performed in duplicate) and interpretations Test reference intervals adjusted for age, sex or race, when required 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 VANEHS facility. Frequency 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. Logical Observation Identifiers Names and Codes (LOINC) code 6. Specimen Preparation and Storage AT VANEHS The Contractor shall provide at no additional charge an adequate supply of specimen collection materials for testing and handling as dictated by the commercial reference laboratory s specimen collection requirements, i.e. dry ice, stabilizing tablets, ice packets, etc. The Contractor shall be responsible for transporting and storing specimens in such a manner to insure the integrity and security of the specimens. The Contractor shall provide a specific transport contingency plan during periods of inclement weather. Procedures for notification of affected VANEHS sites will be incorporated into the plan. 7. Transportation Services for Reference Testing Specimens Transported items will be primarily biological substances (patient specimens). 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. Microbiology cultures, stocks and regulated medical waste that are also in Division 6.2 will be transported. Contractor to provide a specific transport process for each specimen type (refrigerated, frozen, room temperature). Routine transportation services shall occur once per day, with pick-up occurring between 4:00PM and 7:00 pm, local time, unless a different time is mutually agreed upon the by VANEHS facility and the Contractor, Monday- Friday excluding Federal Holidays. Emergency transportation services shall be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 3 hours after notification by any VANEHS facility. Specimen loss due to breakage, spillage, insufficient dry ice or other temperature related problem, misplacement, mishandling or any other Contractor-related problem(s) will be considered unacceptable. Repeated problems with compromised specimens may be grounds for termination. Contractor shall provide follow corrective action, if applicable, for each issue reported to minimize reoccurrence. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be reported to the appropriate VANEHS facility immediately upon unpacking at the Contractor s laboratory. The Contractor shall be required to pick-up the new specimen at no additional cost to the Government. The pick-up of the new specimen must be made during the routine courier pick-up times, unless emergency pick-up is requested. 8. The Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen with the aid of barcode technology. Proof of tracking and reconciliation shall be available to any VANEHS laboratory employee upon request. 9. Patient Service Centers (PSC) shall be located within 4 miles of the outpatient center it will serve. The PSC will provide specimen collection and specimen processing as agreed upon. Specimen Collection Veteran patients shall be correctly identified using two VA-Accepted forms of identification. Full Name and Full SSN or Full Name and Full Date of Birth are acceptable Specimens shall be labeled with VA printed labels when available; handwritten labeling is discouraged. Security PSC s shall ensure the security of VA Patient specimens, Personally Identifiable Information (PII), Protected Health Information (PHI) and VA Sensitive Information shall be safeguarded at all times. VA patient specimens and paperwork will be secured until handed off to a trusted courier. Becton Dickinson collection tubes are used at the VANEHS facilities and are preferred. The contractor shall provide a list of collection tubes that will be used at the PSC s. The VANEHS contacts will be notified immediately of any collection supply changes after the contract is awarded. Shall offer a mechanism for VA patients to schedule specimen collection appointments in order to decrease wait times. 10. Specimen Testing The Contractor shall provide timely and appropriate testing of patient specimens as requested by VANEHS facilities. Contractor shall provide Emergency testing services for all procedures VANEHS deems necessary. The test results shall be reported within four (4) hours from the time the specimen is received in the Contractor s reference laboratory. Problem resolution for specimens not immediately processed/tested or needing further clarification must be handled by the next business day after receipt of specimen at the Contractor s processing facility. Any specimens discovered to be broken, leaked, or otherwise compromised upon unpacking shall be reported to the appropriate VANEHS facility immediately upon unpacking at the Contractor s laboratory. The Contractor is required to pick-up the new specimen at no additional cost to the Government at the next routine courier pick-up unless emergency pick-up is requested. 11. Specimen Retention Specimens shall be stored by the Contractor for at least fourteen 14 days after the reporting of results. The VANEHS may request repeat determinations or add-on tests by telephone during this 14 day period. When test results do not fit the clinical picture of the patient, repeat testing may be requested and must be performed at no cost to the Government. Specimen retention applies to blood, serum, CSF, urine, and other body fluids. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the VANEHS site in writing or tough telephone communication. All anatomic pathology specimen(s) (e.g., blocks, slides or other diagnostic material) must be returned by courier or expedited shipping methods to the submitting facility within seven (7) days after final diagnosis. Point to point tracking will be required to ensure safe and secure delivery of these specimens. 12. Reporting of Results A report of laboratory testing results is defined as host to host electronic transmission of test results. The Contractor shall deliver these reports by electronic report transmission via computer interface. 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 shall, at minimum, include the following information: Patient s full name Patient s date of birth Patient s full social security number or unique hospital identification number Ordering Physician s name Date/time of specimen collection, when available Date/time test completed Test(s) ordered Test result(s) Flagged abnormal results Type of specimen/source Any additional comments related to test provided by ordering physician, if applicable Unsatisfactory specimen shall be reported with regard to its unsuitability for testing VAMC Lab accession number, if supplied VAMC submitting facility name Patient location if supplied Date/time specimen receipt Abnormal intervals/Toxic & therapeutic ranges, if applicable Any other information the laboratory has that may indicate a questionable validity of test results. VAMC facility account number Contractor accession number Contractor address Contractor CLIA number Reference intervals Testing laboratory name The test results must be received by each VANEHS facility in accordance with the test set-up schedule submitted with the offer and made a part of this effort. Electronically transmitted test results shall be received by the VANEHS facility within 1 hour or less of test completion. Preliminary reports shall be delivered for those tests requiring such, as specified by the test schedule. Numeric test results or test results suitable for the result field in the computerized patient record (CPRS)/VA Vista shall be sent via a discrete test field rather than transmitted via a comment. The contractor shall provide a contingency plan in the event the electronic transmission of results is disabled or not functioning. The plan shall be included with the contractor s offer. Critical test results as defined by the Contractor s commercial reference test manual shall be communicated by telephone to a designated VANEHS contact person(s) at the originating VANEHS laboratory facility upon verification of the critical test result. The VANEHS laboratory will provide the contractor with point of contact information for critical test results at each site. Each VANEHS laboratory is responsible for communicating critical test results received from the contracted commercial reference laboratory to the ordering clinician or designee. 13. Telecommunication Requirements A VHA 6550 shall be required at time of proposal 14. After award, the commercial reference laboratory contractor shall provide to the VANEHS all necessary laboratory test parameters to ensure accurate test result transmission between the VANEHS and the contractor s database. 1. Required test parameters include: a. Ordering code b. LOINC code c. CPT code d. Interface code e. Test cost f. Reference ranges g. Units of measurement h. Test result interpretation or interpretive remarks, if appropriate i. Testing site (if not performed at the contractor s main laboratory facility) j. Test methodology k. Specimen types l. Specimen collection and handling requirements m. Whether test is a panel or profile test, list of tests included (NOTE: above parameters are required for each test contained in a panel) 2. The parameters for all tests in the Contractor s database shall be kept current and be available to the VANEHS sites toughout the performance period. Updates to the test parameter information shall be provided to VANEHS sites prior to any testing changes in the following situations: 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 information to VANEHS sites no less than 2 weeks prior to the implementation of the test change. In an effort to maintain accurate and timely test information, the Contractor shall provide telephone access to a Contractor s representative to respond to any question(s) regarding the laboratory test parameter information. 3. VistA Laboratory Electronic Data Interchange (LEDI) identifies VA-specific content and encoding tables to be used with HL7 message protocol conventions. LEDI identifies encoding tables and HL7 message protocol conventions. VistA LEDI 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. VistA 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 shall contain VANEHS s assigned specimen identification where specimen identification is defined as a unique VANEHS-assigned 10 digit 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. 4. The Contractor shall provide VANEHS with specimen status in response to electronic and verbal query. Upon testing completion, a formatted HL7 message containing specimen results with VANEHS s assigned specimen identification shall be returned to the requesting medical center. 5. The Contractor shall conduct preventive maintenance and repair of contractor furnished hardware, software and associated communication lines. In addition, toughout the performance period, the Contractor shall repair or replace any malfunctioning hardware or software within 72 hours. 6. The 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 VANEHS is capable of performing routine servicing of hardware. 7. The Generic Instrument Manager (GIM) will be located in a VANEHS secured area. The Contractor shall coordinate with the VA Information Technology Department to access the GIM. 8. The Contractor shall install, and if necessary remove all telecommunication equipment and associated hardware. 9. Contractor shall address within two hours of initial inquiry, interface questions where information is required to update, maintain and support the services of the host-to-host linkage between the VANEHS and the Contractor. 10. Contractor shall begin implementation of the telecommunications requirements described in this solicitation no later than 90 calendar days after the award. Failure to provide timely implementation is grounds for termination. 11. In order for contract performance to begin within the shortest time possible after contract award, Contractor must already possess a current VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor s host computer system and the Government s host computer system (VistA). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.) 12. 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 toughout the performance of the contract. 13. Contractor shall provide, install, and if necessary remove, all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to all sites VANEHS. This may include, but is not limited to: 1) Generic Instrument Manager (GIM) for the interface connection 2) Shipping list printers 3) Bar-code printers 4) Back-up result printers connected directly to Contractor s computer system 5) Any required communication lines 6) Software to receive and send orders, display status of and/or test results 7) Consumable supplies to maintain the operation of the equipment listed above, e.g. toner, etc. 14. 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. 15. The Contractor shall conduct 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. 16. All electronic messaging between the two (Contractor and Government) host computer systems using the GIM shall utilize VistA Health Level Seven (HL7) technical specifications. Version of HL7 shall be current VA standard. 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 tough the Health Level Seven, Inc. web-site, www.HL7.org. 17. VistA Laboratory Electronic Data Interchange (LEDI): identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. LEDI identifies encoding tables and HL7 message protocol conventions. 18. 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. 19. (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. 20. 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. 21. 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. 22. Meeting the below specified deadlines are of utmost importance to the Government. As such, Contractor shall have an operational interface connection with the VANEHS facilities within 90 days of contract award. The establishment of the test database will be the responsibility of the Government and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmissions tough the interface connection will be the joint responsibility of the Government and Contractor. Test database construction and transmission validation will occur using a phased approach that occurs over the periods of time listed in the table below. Identification of specific test names for each phase will be provided after contract award. Interface priority will be based on highest annual volume tests. Phase List of Test Names Test Transmission Validation Time Periods 1 Test Numbers 1-125 1-90 days after interface connection 2 Test Numbers 126 - 500 91 days - 6 months after interface connection 3 Test Numbers 501 and above As needed tough life of contract The Contractor shall certify in writing successful test validation on the final day of the time periods indicated for Phase 1 and Phase 2 listed above. Written certification will not be required for Phase 3, as test establishment and validation will occur on an individual, as needed basis. 15. Customer Service 1. At the time of award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services toughout the performance period. Customer service shall be accessible by toll free telephone service 24 hours per day, 7 days per week to assist VANEHS staff for tracking and resolving related issues that may arise in the performance of this effort. Contractor to provide a communication plan in their offer to include the following at a minimum: Telephone Inquiries Telephone inquiries are divided into five major categories with additional subcategories defining the type of inquiry and the VANEHS s minimum time expectation for meeting this service. 2. 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. 3. Testing Status of Ordered Testing inquiries regarding the status of pending orders shall be addressed at the time of the initial call. Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call. Set-up fees will not be charged by the Contractor for cytogenetic tests showing no growth. 4. Billing Inquiries 5. 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. Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call. Account follow-up that requires 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. 6. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability, e.g. volume, specimen container, identification, loss of specimen, etc. no later than the next business day from specimen receipt. The contractor shall provide a problem log by fax, to the sending VA site, which electronically documents communications between the contractor lab and the VA sending site regarding test inquiries. The contractor shall follow-up by phone call to ensure any issues are resolved. 7. The VANEHS will place orders for specimen collection and transportation supplies by telephone or tough written or electronic methods. 16. Data Management System The Contractor shall provide a data management system that meets the following minimum requirements: 1. Test ordering will be done via electronic transmission and use of the VA shipping manifest. Those tests that cannot be ordered in this manner will be ordered 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. The Contractor shall only accept add-on written or verbal orders from authorized laboratory personnel. 2. Test definition, test information and test requirements must be complete, available and easily accessible in an integrated, electronic, directory of services. 3. Shipping manifest shall be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered. 4. The status and the results of testing shall be available within contractor published timeframes as described in the electronic Contractor Directory of Services and accessible electronically tough the contractor s online account for each VANEHS. At a minimum, the options must include by site: 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 must be generated when testing is delayed beyond published timeframes, when specimens require additional testing (reflex), or specimens are cancelled due to unacceptability. 5. Reports of test results shall be immediately available upon verification of the test result. The contractor shall offer an online portal in order to print test results on demand or reprint retrospective test results according to a defined timeframe. 17. Performance Improvement Activities The Contractor shall participate in a joint quality assurance monitoring program with the VANEHS COR and VISN 1 NCL Quality Manager. 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 VANEHS with details as to who 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 performance improvement program will be developed during post award meetings. The Contractor will also conduct a business review quarterly with the COR, CO and other VA personnel. I. Utilization Reports These reports will be at no additional cost to the government. 1. The Contractor shall provide a statistical analysis of the VANEHS facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities and/or VANEHS COR on mechanisms to reduce their costs. The analysis will be for each VANEHS sending institution as well as a VANEHS rollup. This utilization management tool can help control expenses and improve clinical care. It will ensure that clinicians are ordering the right tests and that the VANEHS is getting the proper return for laboratory testing dollars. The management tool supports clinicians in delivering evidence-based care that improves quality metrics, which leads to improved financial performance. The utilization report can drill down to organization or provider level to view utilization trends and patterns on a daily, monthly, quarterly, or annual basis. 2. The contractor shall electronically distribute reports (In a sortable Microsoft Excel format) to the COR/ VISN 1 Network Consolidated Laboratory office by the 15th of the month following the close of the reporting month: a. A monthly cumulative summary of tests performed, by dollar volume, for each facility. Summary must indicate the tests in descending order based on dollar volume, volume of tests ordered, unit price for each test, monthly expenditures and year to date expenditures. The data from each site shall be rolled up into a VISN 1 Master Summary. b. A cumulative summary of tests performed sorted by test frequency for the entire VANEHS. Summary must include a break-down of the tests ordered by each facility, the volume of tests ordered, unit charge per tests, and total charges. J. Implementation Time Frame - The performance period of the reference laboratory services requirements described in this solicitation must be completed within 90 calendar days after the award A. Failure to provide timely implementation is grounds for termination. Offerors must furnish a schedule to show implementation plan. K. Miscellaneous Responsibilities - The Contractor shall keep each facility, COR and other key personnel informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests tough periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide updates at least quarterly. L. Medical Liability Insurance - Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance shall 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. M. Contractor shall not, under any circumstances, furnish reports directly to patients. II. REQUIREMENTS FOR COURIER SERVICES A. General 1. The Contractor shall provide, in accordance with the specifications outlined below, courier services for the VANEHS locations. Services shall include transportation of clinical laboratory specimens between the following: a. Intra VA VANEHS laboratories to include community-based outpatient clinics (CBOCs) 2. All requirements and provisions defined in the specifications of this solicitation shall apply to any entity, i.e. branch, division, sub-contractor, etc. performing courier services on behalf of the Contractor. B. Description of Services 1. The Contractor shall provide courier services between the VANEHS facilities and CBOC Locations and the main VA Facilities as needed. Exact locations to be identified in the RFQ. 2. Transported items shall be primarily biological substances (patient specimens). 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. Microbiology cultures, stocks and regulated medical waste that are also in Division 6.2 shall be transported. Other incidental items (not included in Division 6.2) that may be transported include, but may not be limited to, laboratory testing reagents (of limited size and quantity), holter monitors, x-rays, patient reports or other paper work. 3. The VANEHS facilities shall be responsible for the processing of biological substances in preparation for transportation. The VANEHS will provide a shipping manifest minimally detailing the dates and times of receipt and delivery and the number of patient specimens transported by temperature category. 4. The Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen with the aid of barcode technology. 5. Requirements 1. The Contractor shall provide safe transport of all biological substances. This must include the proper receipt, distribution, storage and security of patient specimens in accordance with all federal* regulations governing the safe transport of these materials including, but not limited, to the following: Department of Transportation 49 CFR Parts 171-180 Hazardous Materials: Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule. Department of Health and Human Services 42 CFR Parts 72 and 73 Interstate Shipment of Etiologic Agents and Select Agents and Toxins Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens Health Information Portability and Accountability Act (HIPAA) Privacy Rule 45 CFR Parts 160 1nd 164. * State and local regulations may be applicable if more stringent and do not conflict with the federal regulations. 2. The Contractor shall include a program that ensures the accountability and integrity of all biological substances from the point of possession to the point of delivery with their offer. Critical elements of the program are as follows: Education of all transport personnel on the policies and procedures for the receipt, tracking and delivery of these packages. Overall and day to day coordination of the courier schedule to include dispatch, timeliness and communication. Provision of a contingency system to insure 100% courier route performance. Provision of a specimen tracking system that prevents any loss of specimens. Any loss of a specimen is considered serious and potentially has negative clinical impact. The tracking system shall be point to point with individual specimen reconciliation using barcode technology. Monitoring its proper handling of the specimens to ensure their quality or integrity. Provision of emergency contact information to address inter-route issues that occur. A direct contact (other than the courier/employee) must be designated for immediate response to courier service issues. This contact must be available for emergency response within the timeframes covered in the courier route plan and toughout extended time periods when the courier is not able to meet the stated delivery times. In addition, this contact must have the capability to be in immediate communication with the courier employee performing the services in cases of emergency or to determine location. The contact information, i.e. name(s) and/or offices and telephone number(s), for these emergency contact personnel must be available at the time of award. Designation of a maximum of two coordinators to organize activities, monitor services and respond to customer service problems. Development of a quality assurance program for identifying and correcting transportation issues. Specific operational procedures will be mutually agreed upon between the VANEHS and the Contractor at the post-award meeting(s). Procedures must include at a minimum, written response from the Contractor to deviant occurrences regarding the circumstances and the corrective actions. 3. The Contractor shall 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. Critical elements of the training program shall adhere to the regulations for the transport of hazardous materials as cited in 49 CFR 172 Subpart H and will minimally include: Education on the types of biological materials transported including definitions of an infectious substance and a biological product. Education on appropriate hazardous material packaging and labeling in order to recognize non-compliance. Requirements for the appropriate receipt of the packages including the availability of shipping manifest. The use of appropriate containers to transport specimens between the point of origin to the transport motor vehicle and, likewise, from the transport motor vehicle to the destination point. Appropriate installation, use and security of environmental temperature control devices that maintain ambient, refrigerated, frozen or incubated conditions that insure the integrity of the specimens and avoid loss or breakage of the containers. Identification of specimens requiring environmental temperature control storage. Certified education (hazmat training) on appropriate decontamination and notification procedures in case of accident or spills. This includes the identification and appropriate use of personal protective equipment and the use of mitigation and disinfection products. Education on procedures for hazardous spill communication, i.e. contact telephone numbers. Education on the protection of the privacy and confidentiality of the personally-identifiable information 4. The Contractor shall provide to each VANEHS facility all materials necessary to comply with the logistics of a transportation program. This includes an adequate supply of materials necessary for the efficient, organized and coordinated receipt, transport, and delivery of specimens (e.g. bags, temperature condition stickers, transportation receipt forms, rigid-sided containers, dry ice, coolers, incubators, etc.). Temperature integrity tracking data shall be available upon request. 5. Implementation Time Frame - The performance period of the courier services requirements described in this requirement must begin no later than 90 calendar days after the award. Failure to begin performance within 90 days is grounds for termination. III QUALITY/QUALITY ASSURANCE The Government reserves the right to physically inspect the reference laboratory/laboratories and Patient Service Center s (PSC s) prior to award and at any time during the award period to insure the reference 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. The Contractor shall grant access to the Government to physically inspect the courier contractor/subcontractor and courier/subcontractor motor vehicles prior to award and at any time during the performance period to insure 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. The Contractor shall successfully perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor must provide the COR a listing of external proficiency surveys in which the laboratory participates in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to COR or designee upon request. All test methods must be FDA approved, when available. Any non-FDA approved method being performed must have a documented validation plan. Upon request, the validation plan and validation results must be made available to the COR or designee. Because these tests are critical to the accurate diagnosis of patients, a timely response to customer service requests and maintenance of specimen integrity is paramount. All aspects of this requirement carry with them extra scrutiny for low quality performance. Contractor s failure to meet these tasks will result in the disincentives established in the Quality Assurance Surveillance Plan (QASP). Quality Control: The contractor shall operate a successful quality control program as required by CLIA and CAP. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission and regulations to perform the type of services required. The government shall evaluate the contractor s performance under this effort in accordance with the QASP. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contracting laboratory. Each specimen that is lost by the contracting laboratory will incur a charge of $100.00 that shall be credited to the Government on the monthly invoice. Identification of Contractor Employees: All contractor personnel attending meetings, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. IV. Continuing Education - Minimum to be provided, not separately priced, to the Government for VANEHS Pathology and Laboratory Medicine Service. VANEHS requests that the contractor: Provide in-service seminars at a minimum of one per year at a central location designated by the Director of the Network Consolidated Laboratory (NCL), VANEHS. The seminar shall include updates on laboratory testing procedures, plus management training, tips on keeping staff motivated, -or other appropriate laboratory-related topics and should be customized to meet the need of the VANEHS Pathology and Laboratory Medicine Service. Provide a technical support system that assists VANEHS NCL in establishing new procedures for new tests within the NCL Network. Continuing Education to be held a minimum of once per quarter: A list of topics for technology update seminars to be provided to Technical Specialists, Laboratory Management, Staff Members and Faculty as well as a schedule of upcoming dates of events shall be presented with the proposal. Submit samples of literature and education materials to be provided during life of effort. No proprietary or promotional materials shall be included in the educational presentations. V. National MOU - ISA HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) Contractor shall 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 (VA). VA has recognized that Diagnostic Laboratory Testing Facilities, are Health Care Providers and the PHI is being disclosed and/or used for treatment of an individual, and are entities that do not require a BAA with their contractors as long as they are conducting health care on VA s behalf Reference Laboratory Services qualifies as a medical service therefore, no BAA is required. However Courier Services are not rendered treatment of an individual and the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA. RESPONSE COMMITMENT I. NOTES: A. All questions, comments or concerns shall be directed to Valerie.DeAngelis@va.gov. B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility to participate in a future acquisition does not depend upon a response to this notice. C. Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). II. TIMELINE: A. This request will close on stated date within the FBO site. III. Requested information: Interested parties shall provide the following information in addition to your capability response: A. Format: 1. MS Word or pdf format (please ensure email is under 5 mb) 2. Page limit 2-4 pages (please make the response as brief and concise as possible) 3. Company name and Sources Sought number listed on each page B. Specifics: 1. In your response, please provide the following information based on the requirement. a. Your company s capability of fulfilling this requirement as it is described. 2. Please also provide name of company, company address, a contact person s name, telephone number, fax number and email address. 3. DUNS number, and indicate if actively registered on System for award management (SAM) 4. Contractual vehicles the company holds, such as NAC or GSA schedules. 5. Socio-economic Status & NAICS Code: State the size of your company [e.g., 8(a) (including graduation date), HUBZone-certified small business, Service- Disabled Veteran-Owned small business, small business, large business, etc.]. VA24117R0030 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1
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