Inactive

REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in respons... REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e). SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a RFI/sources sought only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 541380 (size standard of $16.5 million). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following: Alpha-1 antitrypsin Buccal Swab Testing BACKGROUND Alpha-1 antitrypsin (AAT) is a protein that has both anti-inflammatory and anti-proteolytic functions and serves to limit protease-induced injury to lung matrix proteins. A deficiency of AAT predisposes patients to chronic obstructive pulmonary disease (COPD) as well as other disorders including bronchiectasis and liver disease. Early identification of patients with alpha-1 antitrypsin deficiency (AATD) allows for interventions that can slow the effects of this disease, and improves morbidity, loss of lung function and mortality. The AAT buccal swab test is minimally invasive, allowing for collection in clinic as soon as at-risk patients are identified, therefore increasing detection of the disease. SCOPE OF PROCUREMENT: The Government is looking to establish a BPA or requirements contract for Alpha-1-antitrypsin Buccal Swab Testing Services. Alpha-1-antitrypsin Buccal Swab Testing Services include but are not limited to specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services. This will be a single vendor award with one base year and four one-year options. VISN 15 intends to establish the base year of the agreement starting on or about 12/1/2021, with contract completion on 11/30/2026. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide comprehensive genomic profile services to Kansas City VA Medical Center and it s respective CBOCs. GENERAL QUALIFICATIONS Alpha-1-anti-trypsin Testing The contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Alpha-1-anti-trypsin Buccal Swab Testing Services to Kansas City VA Medical Center and it s respective CBOCs Alpha-1-anti-trypsin Buccal Swab Testing Services include but are not limited to: specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services. Orders will be initiated when ordered by a physician. Each test will be patient specific; the need is Veteran specific. The Contractor shall provide electronic access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital Information System (HIS) or current Government Laboratory Information System (LIS). This information, at a minimum, shall include the following data elements: Ordering Code (Contractor's Identification Code) LOINC - Logical Observation Identifier Names and Codes Test methodology Test Description, including reference ranges (when appropriate, age and sex adjusted) and units of measurement Specimen collection and handling requirements Test result interpretation or interpretive remarks, if appropriate All testing shall be performed on the Contractor s premises, or within the Contractor's network of laboratories. Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America. Licensing, Accreditation and Certifications Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to BPA award. Changes to the requirements shall be addressed by bilateral modification. Contractor Personnel assigned by the Contractor to perform the services covered by this BPA shall be eligible to provide the services of this BPA 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 BPA shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this BPA shall be licensed by the governing or cognizant licensing board. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the BPA within 24 hours of notification of an investigation or suspension. Contractor Personnel: The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. CONTRACTOR S RESPONSIBILITIES: Specimen Preparation and Storage or 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. The testing methodology and reference ranges for a test must be defined in the Contractor s laboratory reference test manual. The Contractor shall ensure that all tests performed meet the currently acceptable standard deviation and that have daily controls conducted to determine testing accuracy. Upon request by the Contracting Officer (CO) or assigned Contracting Officer s Representative (COR) for the applicable facility and the Contractor shall make available quality assurance information on specific testing procedures for review. Supplies: The Contractor shall provide all materials and necessary supplies to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials and supplies include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. Testing materials and supplies include: Requisition forms Special instructions Specimen transport containers and shipping forms, to include refrigerated packaging (if applicable). Special media or tubes for samples Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. The Contractor shall contact the assigned COR for the applicable facility within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies. The Contractor shall provide a mechanism for specimen pickup. The Contractor shall provide to the ordering facility the supplies and equipment within two (2) workdays after receipt of order. The assigned COR or assigned representative for each facility will request replenishment of supplies from the Contractor on an as needed basis. Transportation Services for Samples: 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.). The specimen will be returned to ordering facility, free of charge. Specimen Testing The Contractor shall provide the full range of clinical diagnostic testing capabilities to execute all required Alpa-1-anti-trypsin testing services as annotated in Attachment A. Contractor shall make available the following test information: Requisition form requirements 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 Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a Government facility. Schedule of test performance (specific days of week indicated) Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab). Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials. Reporting of Results A report of laboratory testing results must be issued either as a printed final copy or through the host-to-host electronic transmission of the test results. The Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing 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. Each test report shall, at minimum, include the following information: Patient's full name Patient s identification number, e.g. social security number (SSN) Physician s name (if supplied) Government laboratory accession number (if supplied) Submitting facility name Submitting facility account number Patient's location (clinic/ward) (if supplied) Test(s) ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference laboratory accession number Name and address of testing laboratory Any other information the laboratory has that may indicate a questionable validity of test results. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission. Customer Service Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day; 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this BPA. 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 BPA performance period: 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. 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 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 and materials by telephone or through written or electronic methods. Consultative Services 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. SPECIAL CONTRACTOR REQUIREMENTS Federal Holidays Contractor is not required to provide transportation of specimens on federal holidays. The 10 holidays observed by the Federal Government are: New Year s Day (January 1st) Martin Luther King s Birthday (3rd Monday in January) Presidents Day (3rd Monday in February) Memorial Day (last Monday in May) Juneteenth (June 19th) Independence Day (July 4th) Labor Day (1st Monday in September) Columbus Day (2nd Monday in October) Veterans Day (November 11) Thanksgiving Day (4th Thursday in November) Christmas Day (December 25th); and Any other day specifically declared by the President of the United States to be a national holiday. Qualifications/Requirements of Laboratory & Contractor Personnel Laboratory Offeror must have at least three years of experience in providing laboratory testing services and must have at least one-year experience in transporting biomedical materials. 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 reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout 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 Contracting Officer s Representative assigned to each Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor. Contractor must notify immediately the Contracting Officer s Representative (COR) at each of the Government facilities in writing, upon its 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. Contract Performance Monitoring- Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through 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 VA 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. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. Quality Assurance Monitoring Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract. The Government shall verify that services being performed by the Contractor are acceptable and in accordance with established standards and requirements of this contract. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. 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/VISN 15 staff for process review and improvement of contract performance on an as needed basis. Copies of licensure/certifications are also required to be submitted upon request Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc. Quality Assurance/Quality Control The Contractor facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government at any time during the term of the contract. The Contractor shall comply with all applicable OSHA, Federal laws, State laws, the Joint Commission, and regulations as required for performing the type of services required. The Contractor shall comply with the following Quality Assurance guidelines relating to shipping and test performance: Number of modified test results, not due to incorrect requisition information from the referring lab: <0.02% per year In all cases, surveillance shall not be so intrusive as to impact the Contractor s successful accomplishment of the mission. When unacceptable performance occurs, the assigned COR for the facility shall inform the Contractor and contracting officer. This notification shall normally be in writing unless circumstances necessitate verbal communication. In any case, the assigned COR for the facility shall document the discussion and provide a copy of the document to the Contractor and Contracting Officer. When the assigned COR for the facility determines formal written communication is required, the assigned COR for the facility shall prepare a Contract Discrepancy Report (CDR) and present it to the Contractor's program manager and the Contracting Officer. The Contractor shall acknowledge receipt of the CDR in writing. The CDR shall specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR shall also state how long after receipt the Contractor must present this corrective action plan to the assigned COR for the facility. The assigned COR for the facility and Contracting Officer shall review the Contractor's corrective action plan to determine acceptability. All CDRs may become a part of the supporting documentation for any action deemed necessary by the Contracting Officer. Quality assurance monitoring documentation shall become an official Government record of the Contractor s performance. Transportation Specimen Shipment Sample Preparation: Each ordering activity shall prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user s manual. The Contractor shall provide at no charge an adequate supply of requisition forms, specimen collection materials, cooling packs, and special instructions. These requirements shall be defined in the laboratory user manual. The Contractor shall supply any special preservatives required for specimen preservation. Each ordering activity is responsible for packaging the specimens. Shipping Biological and Infectious Substances: Regulatory Requirements. The regulations governing the packaging and shipment of biological, infectious, and hazardous substances are primarily found in 49 CFR parts 100-185 and 397. The parts of 49 CFR specifically dealing with biological and infectious specimens are 107, 171, 172, and 173. While the majority of shipments packaged and processed by the clinical laboratories are classified as diagnostic specimens, all specimens, as well as any select agents and toxins that are identified, must be packed and shipped in accordance with the applicable guidance provided in 49 CFR. Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the Centers For Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the Department of Veterans Affairs. Release of Medical Information: The Contractor shall release medical information obtained during the course of this contract to authorized VISN staff. SERVICE DELIVERY SUMMARY Performance Requirement SOW Reference Performance Measures The Contractor shall provide reference laboratory s current license/accreditation by the College of American Pathologists (CAP). GENERAL QUALIFICATIONS Licensing, Accreditation and Certifications 100% - No deviations accepted Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. GENERAL QUALIFICATIONS Licensing, Accreditation and Certifications 100% - No deviations accepted The Contractor shall contact the assigned COR for the applicable facility within a minimum of five (5) calendar days after BPA award to coordinate the furnishing and delivery of specimen collection and transportation supplies. CONTRACTOR S RESPONSIBILITIES: Specimen Preparation and Storage or specimens 97% of time The Contractor shall provide to the ordering facility the supplies and equipment within two (2) work days after receipt of the order. CONTRACTOR S RESPONSIBILITIES: Specimen Preparation and Storage or specimens 97% of time Changes to test information modifications shall be made to the Government no later than two weeks prior to implementation date of test change. CONTRACTOR S RESPONSIBILITIES: Specimen testing 100% The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission, and regulations as required for performing the type of services required. SPECIAL CONTRACTOR REQUIREMENTS Qualifications/Requirements of Laboratory & Contractor Personnel 100%. No deviations accepted. The information identified above is intended to be descriptive, not restrictive, and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number. Please submit your capabilities that show clear, compelling, and convincing evidence that you can meet the requirement described in the attached SOW. Please provide your DUNS number. Responses to this notice shall be submitted via email to Tracie Raggs at tracie.raggs@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Thursday, October 14, 2021 at 2300 CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation