Synopsis: Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. Network Contracting Office (NCO) 2 of the Department of Veterans Affairs is currently conducting a market survey for qualified firms capable of providing New Jersey VA Healthcare System Neuropathology Testing and Supplies The North American Industry Classification Systems (NAICS) is 621511. Responses to this notice must be submitting in writing (email) and must be received not later than December 8, 2021 at 10:00AM. Email: Janice.Brooks@va.gov. No telephone inquiries will be accepted. Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business), relative to NAICS 621511. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Neuropathology for Testing and Supplies PERFORMANCE WORK STATEMENT Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Neuropathology for Testing and Supply Services to Department of Veteran Affairs (VA) New Jersey Health Care System (NJHCS) described herein. Neuropathology for Testing and Supply Services include, but are not limited to: specimen preparation and storage; transportation of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services. Tests performed must include Skin Biopsy Analysis for Epidermal Nerve Fiber Density (ENFD), Sweat Gland Nerve Fiber Density (SGNFD), Muscle Biopsy Analysis, and Nerve Biopsy Analysis as detailed in Attachment A. I. Specimen Preparation and Storage for Testing Specimens Contractor shall supply each Government facility with its documentation to insure 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. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen. Transportation Services for Reference Testing Specimens Contractor shall provide transportation of primarily biomedical materials that include patient specimens 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 on an as needed basis, approximately 0-1 times per week, from the VA New Jersey Health Care System. Specimen pick-up times will be negotiated after contract award. Alternatively, vendor will supply kits including all necessary packaging for mailing and specimens will be mailed to the vendor s testing facility. 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. Specimen Testing The Contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment A, approximately 50 tests annually. Contractor shall make available the following test information to include maintenance and support services: 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 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, 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. Any new test(s) not listed in Attachment A must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested. 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 (defined in Attachment A) 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 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 as stated in Attachment A. 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. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery 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 Section Telecommunication Requirements below. 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 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 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 Monday through Friday during normal business hours 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 VA 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 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 and 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 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. SPECIAL CONTRACT REQUIREMENTS Services The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract. Contractor shall not, under any circumstances, furnish reports directly to patients. II. Term of Contract This contract is effective for an estimated period of Date of Award (DOA) through Completion, including any exercised options. The contractor shall perform no services after 12th month of service of each year until the contracting officer authorizes such services in writing. III. 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), 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. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies. IV. Qualifications/Requirements of Laboratory & Contractor Personnel A. Laboratory 1) 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. 2) Offerors, including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract. 3) Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending 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. 4) 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. B. Personnel Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards. Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402). Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within VA established timeframes. 5) Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor s company. In addition, the Contractor representative shall prominently display a contractor-issued identification badge. V. 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 (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor s proposal have been compared against the OIG list and are NOT listed as of the date the offer was signed. VI. Record Keeping Contractor Contractor must establish a record keeping system of all tests performed. VII. Medical Records Clinical or other medical records (i.e. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA. If requested, test results will be mailed to the VA at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received. VIII. CONFIDENTIALITY OF PATIENT RECORDS A. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. B. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA s records, at VA s place of business on request during normal business hours, to inspect and review and make copies of such records. IX. 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 (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services. X. Designation of Contract Representatives Pathology and Laboratory Medicine Service of the VA New Jersey Health Care System will appoint a Contracting Officer s Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract and who 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 will be provided in the COR Delegation Memo. XI. Contract Performance Monitoring Contractor's employee(s) shall report to the Anatomic Pathology Department upon arrival at the VA for specimen pickup. B. 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/Attachment A. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. Departments being served, through the COR(s), will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable). XII. Required Registration with Contractor Performance Assessment System (CPARS) As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) 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 through the Past Performance Information Retrieval System (PPIRS). 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 VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. 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 PPIRS without contractor s comments. [End of Special Contract Requirements] XIII. CONTRACT SECURITY REQUIREMENTS The C&A requirements do not apply, and that a Security Accreditation Package is not required [End of Contract Security Requirements] Attachment A The Contractor shall provide the following maintenance and support services: Optimized reagents and disposables required for testing: Skin Biopsy Analysis for epidermal nerve fiber density testing and sweat gland nerve fiber density. Muscle Biopsy Analysis: including routine histology, immunohistochemistry and enzyme histology, for diagnosis of muscular dystrophies, inflammatory myopathies such as dermatomyositis or polymyositis, or other metabolic, toxic, or inherited muscle diseases and Electron Microscopy Nerve Biopsy Analysis: including routine histology, teased fiber analysis, and immunohistochemistry for diagnosis of CIDP, vasculitis, demyelinating neuropathies, sarcoid or amyloid neuropathy and Electron Microscopy Replacement reagents and replacement test kits needed to send patient samples. 24/7 Call-in Technical Support Hotline to clarify and troubleshoot and resolve questions about specimens (condition and identification). Reagents and transport test kits are prepackaged, pre-diluted and ready to use. Reagents are sealed air tight. This ensures quality. Transport test kits are sent to us overnight at no charge with requisition forms, pre-paid return FedEx with proper UN3373 packaging. Manage fixative inventory and expiration dates. Receive specimens 6 days a week, including weekends. Test Result reports will be available on a secure password driven online portal set up by vendor and hard copy mailed to pathology. Turn-around time will such that : Skin Biopsy Analysis is 7-10 days for ENFD and SGNFD. Muscle Biopsy Analysis is 7-10 days. Nerve Biopsy Analysis is 10-14 days.
