GENERAL INFORMATION FOLLOWED BY A TENTATIVE PERFORMANCE WORK STATEMENT SOURCES SOUGHT NOTICE This is not a solicitation but rather a Request for Information (RFI/Sources Sought) for market research purposes only. Veterans Health Affairs, Network Contracting Office 4, is issuing this Sources Sought in order to identify capable firms and obtain information for planning purposes only. Veterans Health Affairs, Network Contracting Office 4, is issuing this Sources Sought to identify capable firms for VISN 04 (9 Stations) Reference Laboratory Services. Responses shall be submitted by 12:00pm (EST) October 10th, 2023. Responses shall be submitted via email to Amanda.saunders@va.gov in the Subject: VISN 04 Reference Laboratory 36C24424I0016/(Your Organizations Name). All Service-Disabled Veteran-Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) firms that respond shall include proof of their Vets First Verification via Home  · VetBiz Portal (va.gov). All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with FAR 4.1102 Policy. As determined by the VAAR in section 852.219-73 and 852.219-75, Service-Disabled Veteran Owned Small Businesses need to meet specified requirements, while limiting the amount of subcontracting provided during a given contract. Failure to meet the required stipulations can result in suspension, debarment, fines, and/or prosecution. While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes. All respondents shall include as part of their response a brief capability statement that covers the information in the following tentative performance work statement (PWS), as well as answers to the below three (3) questions. All respondents shall be registered and active in SAM.gov | Home. The purpose of this sources sought is to elicit feedback from industry on our intended procurement approach. The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition approach (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Suggested NAICS: 621511 (Medical Laboratories) Suggested PSC: Q301 (Medical-Laboratory Testing) Open to suggestions from industry as to a more proper NAICS and/or PSC, as well as any potential GSA/FSS Schedule SIN categories. In addition to the information requested above, please include answers to the below 3 questions as part of your response to this Sources Sought: 1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. 2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. 3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company. 4. If responding to this sources sought as an SDVOSB, please provide information to support your ability to comply with the limitations on subcontracting per VAAR in section 852.219-73 and 852.219-75. 5. If responding to this sources sought as a VOSB, please provide information to support your ability to comply with the limitations on subcontracting per VAAR in section 852.219-74 and 852.219-75. Intended Procurement Approach VISN 04 REFERENCE LABORATORY TESTING SERVICES PERFORMANCE WORK STATEMENT (PWS) I SCHEDULE OF SERVICES The Contractor shall provide all personnel, equipment, and services to perform laboratory services to include pickup and transport of specimens to its laboratory; pre-analytic processing as defined in its laboratory user s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation, and result interpretation for the participating facilities in VISN 04 as further described in the Performance Work Statement (PWS) included herein. Note: This list is not all inclusive as patient testing needs may fluctuate throughout the contract period. These fluctuations can occur in both the volume of tests and the test menu. Place of Performance: Services shall be provided at the Contractor s reference laboratory. GENERAL SERVICES REQUIRED: The participating facilities of VISN 04 requires the Contractor to provide reference laboratory testing services on an as needed basis. Contractor will need to provide necessary supplies including but not limited to requisition forms, specimen containers, collection supplies, collection tubes, aliquot tubes, special instructions, specimen carriers, all forms (including chain of custody forms), special media or tubes for viral samples, all supplies for special tests (eg. viral studies), printers and printer supplies, middleware, and software. PLACE OF PERFORMANCE: Services shall be provided at the Contractor s laboratory. All requirements and provisions defined will apply to any laboratory, i.e. branch, division, etc. performing reference testing on behalf of the Contractor. AUTHORITY: Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority. POLICY AND REGULATIONS: The Contractor shall comply with all applicable OSHA, federal and state laws and regulations as required for performing the type of services required, including the Centers for Medicare and Medicaid Services, Clinical Laboratory Improvement Amendments (CLIA). DEFINITIONS/ACRONYMS: CAP: College of American Pathologists. Laboratory Accreditation agency that has deemed status from the Centers for Medicare & Medicaid Services. CDR: Contract Discrepancy Report CLIA: Clinical Laboratory Improvement Amendments. United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States. CMS: Centers for Medicare and Medicaid Services Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings. CPARS: Contractor Performance Assessment Reporting System IAW: In Accordance With Point of Contact (POC): A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with, and adheres to, the specifications contained in the contract and to protect the interest of the Government. The POC shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken. POP: Period of Performance PWS: Performance Work Statement QA/QI: Quality Assurance/Quality Improvement QM/PI: Quality Management/Performance Improvement QASP: Quality Assurance Surveillance Plan Veterans Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is in Washington, D.C. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical center. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA Medical Center. CLINICAL DEFINITIONS/ACRONYMS: Critical Value: A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to VISN 04 upon request. Frozen Section: A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery. Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination. Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the VA. Reference Value. A range of test values expected for a designated population of individuals. Slides. Glass surface containing biological material to be analyzed. Specimen. A body fluid or tissue sample removed for medical examination and analytical testing. STAT. A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases. Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing. Tests. Diagnostic assays to evaluate a patient's physiological condition. Routine Test. A test that is usually performed at high volume in which the result is required in 24 hours generally. Specialized Test. A test that is performed in low volume but the technology, expense, or time-consuming nature of each test, is such that some delay is expected. However, results should be received within a reasonable amount of time to meet patient care needs. The delay usually occurs to allow tests received from different enters to be batch to make the operation cost effected. Esoteric Test. A test that is similar to specialized tests, except they can only be done in a few laboratories throughout the country. TAT. Turnaround time. The length of elapsed time between pick-up or dispatch of specimen from the contractor s laboratory until the receipt of the completed printed/ electronically transmitted report back in the lab. Exception: For STAT tests, the TAT shall begin at the time of notification by the VISN laboratories to the Contractor. These definitions apply whether the contractor or a subcontractor performs the test. Test results shall be received within 24 hours following specimen pick-up either by hard copy or electronic report transmission. It is recognized that certain test procedures will require a longer turn-around time than the 24 hours. The Contractor shall provide a list of the estimated turn-around time for any tests that require longer than 24 hours to complete. Special handling. Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time. Overflow. A test usually performed in a VISN 04 laboratory, which might be referred to the Contractor s laboratory in case of instrument breakdown or other circumstances interfering with the VA s ability to analyze the specimens. Proficiency Testing. An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by many other labs. The proficiency survey is conducted by an organization or agency authorized by HHS to do so. CONTRACTOR QUALIFICATIONS LICENSING AND ACCREDITATION: Contractor shall have and maintain all licenses, permits, accreditation and certificates required by law to operate as a CLIA-certified laboratory. The contractor must be certified and accredited by CLIA, the College of American Pathologists (CAP) and/or The Joint Commission (TJC) and licensed by other federal and/or state regulatory agencies as mandated. A copy of all relevant licensure and certifications must be provided upon award of contract and upon periodic accreditation updates for the contractor and all of their subcontractors if applicable. 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. CONTRACTOR PERSONNEL: The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. The Laboratory Director, medical technologists, medical technicians, and cytotechnologists shall meet personnel qualifications required by CLIA '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General and must possess a valid license to practice clinical reference laboratory services from a United States jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months. The Contractor shall maintain current licenses and certificates for all Contractor personnel and provide copies of such to VA upon reasonable written request. 1. Professional Staff Curricula Vitae 2. Technical Staff Competency Skills Assessment 3. Technical and Courier Staff Shipping and Handling of Laboratory Specimens/Hazardous Materials Training and Assessment 4. CAP and/or any other Proficiency Exam Participation for the past two (2) years 5. Proficiency Examination Exception Reports for the past two (2) years 6. Policy, list of tests and associated results for critical and alert value notification 7. Description of Performance Improvement (Quality Assurance) Program/Plan 8. Current year performance improvement monitors that include and not limited to demonstration of number of lost/damaged specimens, number of cancelled specimens, delays in turnaround times (including but not limited to: due to lack of staffing, lack of availability of reagents, instrumentation issues, etc.), resolution of complaints, errors in reporting patient results, and courier route delays/cancellations 9. Other Quality Assurance Monitors as defined by STVH PROFESSIONAL LIABILITY INSURANCE: Contractor shall maintain professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Insurance Certificate upon receipt of a written request by the VA. CONFLICT OF INTEREST: Contractor is responsible for identifying and communicating to the CO and POC conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the VA OIG has established a list of parties and entities excluded from Federal health care programs. Specifically, 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. Therefore, all Contractors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.hhs.gov/oig to ensure that the proposed Contractors and/or firm(s) are not listed. Contractors should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMPs may also be imposed against the Contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries. By submitting their proposal, the Contractor certifies that the OIG List of Excluded Individuals/Entities has been reviewed and that the Contractor(s) and/or firm(s) are not listed as of the date the offer/bid was signed. SCHEDULE SCHEDULE: The Contractor shall provide services 24 hours a day, 7 days per week, including federal holidays, as required by VA. All services shall be provided within the timeframes specified in Section 4 below. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the POC and the Contractor. FEDERAL HOLIDAYS: The following holidays are observed by the Department of Veterans Affairs: New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Any day specifically declared by the President of the United States to be a national holiday. Unless a state of emergency has been declared or the VISN 4 facilities are closed, the Contractor shall be responsible for providing services. CONTRACTOR RESPONSIBILITIES SERVICES REQUIRED: VISN 04 requires the Contractor to provide reference laboratory testing services as described herein. Attachment A contains a minimum list of orderable tests and estimated volumes for each as well as testing on a paraffin-embedded tissue (to include consultation, immunohistochemistry, molecular testing (anatomic pathology), and in situ hybridization). This list is not all inclusive as patient testing needs may fluctuate throughout the contract period. These fluctuations can occur in both the volume of tests and type of tests required. Therefore, Contractor must have the ability to perform a broad test menu in order to provide additional testing needed as would be expected of a national reference laboratory. Contractor shall provide necessary supplies including but not limited to requisition forms, specimen containers, collection supplies, collection tubes, aliquot tubes, special instructions, specimen carriers, all forms (including chain of custody forms), special media or tubes for viral samples, all supplies for special tests (eg. viral studies), printers and printer supplies, middleware, software. Further details are listed below. Services will include pick-up and transport of specimens to the Contractor s laboratory for processing and testing. The contractor must transport samples in accordance with Department of Transportation (DOT) and International Air Transport Association (IATA) regulations and maintain the integrity of the samples while in transit. Contractor shall be required to provide all equipment and support necessary to provide appropriate interconnectivity between the Contractor s reference laboratory and the VA s VISTA system. VA s interconnectivity requirements are further described in Paragraph 4.10 below. STANDARDS OF PRACTICE: Contractor shall perform services according to the requirements contained in this PWS and services shall be performed in a manner that is equal to or greater than CLIA standards. Testing methodology and reference ranges for tests must be defined in the laboratory user manual. SPECIMEN PICK-UP TIMES: STAT/Emergency: The Contractor shall pick up STAT/emergency specimens within one (1) hour of notification of specimen availability. Routine: The Contractor shall provide routine scheduled specimen pick-up at a time mutually agreed upon by the POC and the Contractor but not less than once each day. When a pick-up courier is required on weekends (if not already scheduled) or federal holidays, the POC or designee shall notify the Contractor, via telephone. PICK-UP LOCATIONS: Contractor shall regularly pick-up specimens as required from the following the VISN 4 facilities: Butler VA Healthcare System 353 N Duffy Rd Butler, PA 16001 Coatesville VA Medical Center 1400 Black Horse Hill Rd Coatesville, PA 19320 Corporal Michael J. Crescenz VA Medical Center 3900 Woodland Ave. Philadelphia, PA 19104 Erie VA Medical Center 135 E 38th St Erie, PA 16504 James E. Van Zandt VA Medical Center 2907 Pleasant Valley Boulevard Altoona, PA 16602 Lebanon VA Medical Center 1700 South Lincoln Ave. Lebanon, PA 17042 Pittsburgh VA Healthcare System University Dr C Pittsburgh, PA 15240 Wilkes-Barre VA Medical Center 111 E End Blvd Wilkes-Barre, PA 18711 Wilmington VA Medical Center 1601 Kirkwood Hwy Wilmington, DE 19805 TEST RESULTS: STAT/Emergency: The Contractor shall provide telephonic, and fax response with test interpretation within no more than two (2) hours of specimen testing in Contractor s testing facility. The Contractor shall report all STAT and abnormal test results to facility that requested sample testing upon completion of testing. Routine: The Contractor shall provide routine test results to the ordering VA facility within twenty-four (24) hours of specimen pick up, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day) and for tests with published longer turnaround times. Test procedures requiring a turnaround time longer than 24 hours (excluding the above exceptions) shall be identified in the Contractor s Laboratory User s manual (paper or electronic or on-line). Telephone Consultation: The Contractor shall consult with the Processing Department, VA POC, requesting Clinician or designee at the VA by telephone as needed. Critical Values: The Contractor shall immediately telephone the POC; requesting Clinician or designee to report Critical Values or test result that may indicate a life-threatening condition. Reporting of Results: A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. If results are telephoned to VA, the report must include the name of the individual who was notified by telephone of the results. Each test report shall indicate, at minimum, the following information: Patient's name and/or identification code (Last four of Social Security Number or Unique Identifier (UID), if provided) Physician's name (if supplied) Patient's location (clinical/ward), (if supplied) Date/time specimen received in Reference Lab Test ordered Date/time of specimen collection (when available) Date test completed Test result Flag abnormals Reference range Toxic and/or therapeutic range where applicable Testing laboratory specimen number Name and address of testing laboratory (contractor and/or subcontractor) Type of specimen Any additional comments related to test provided by submitting VA laboratories. Any other information the laboratory has that may indicate a questionable validity of test results. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. Delays in Reporting Test Results: If for any reason, there will be a delay in reporting of test results the Contractor will contact the VA as soon as they are aware that a delay will occur. Such notification must be made by telephone or facsimile to the Processing Department, POC and the Contractor will provide an estimated time for delivery of delayed results. Email notification will not be accepted. Reporting ICN: For test results being returned to the VA laboratories running VISTA lab, referral labs are to include a VA ICN or VA EDIPI number with patient reports as an identifier. VA referring VISTA labs are to supply the patients VA ICN or VA EDIPI with each lab order to enable the referral lab to include it with results returned to the VA. SPECIMEN HANDLING: Storage of Specimens: The Contractor shall store all specimens as required by regulatory agencies (RA). Upon request by the POC or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall store specimens, after all testing has been completed for the following periods: The Contractor shall store the specimens a minimum of seven (7) to ten (10) days after the test is reported in the event that subsequent action is necessary (i.e. problem solving, add-on test, and/or repeat testing). Cytology and histopathology slides: 25 years Quality Control Slides: When requested by VA, the Contractor shall return slides, tissue blocks, etc., to the requesting VA facility. The Contractor shall provide quality control slides to the VA upon submission of their final reports. Test Samples: Upon provision of sample slides by the VA, the Contractor shall provide interpretation of sample slides. The sample may include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology. CUSTOM PANELS: Contractor shall have the ability to create custom panels as required by VA. Once custom panel is developed Contractor shall be required to ensure the custom panel is available for the duration of the contract. MONTHLY TESTS SUMMARY: The Contractor shall provide to the VA a cumulative (year-to-date) and monthly report of all tests received during the month and for all outstanding results. The report will also include turn around statistics, cost per test (including any additional charges), and specimen or testing issues. CONTRACTOR COMMUNICATIONS: The Contractor shall provide telephone number(s) and a contact person to be used by the VA to make specimen problem inquiries and for problem solving, which must be available 24 hours a day, 7 days a week, including holidays. The Contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation. The Contractor shall assign a specific local account representative to the VA as well as program analyst support for interface troubleshooting and maintenance. Program analyst support shall be made available to the VA Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding federal holidays. INTERCONNECTIVITY (INTERFACE WITH VA SYSTEMS): The Contractor shall provide personal computers (PC) or printers, as needed, and any necessary connection/devices, including one commercial phone line for terminal/data fax connection (if required) for the purpose of providing interconnectivity with VA. Such equipment will be located at the VA facilities identified and mutually agreed upon between Contractor and VA during implementation. Provision of such equipment and supplies by the Contractor shall be understood to include installation, maintenance, and replacement as needed for all equipment necessary for interconnectivity and resulting reporting. Contractor shall transmit the results to Contractor-provided printers located at these VISN 04 facilities. Completed and/or partial test results shall be transmitted to the requesting VA facility to arrive within the published TAT except where specified. The Contractor is responsible for all supplies required for transmission of test results. Contractor shall have the ability to provide interconnectivity between the Contractor s system to and VA s VISTA system for at least 80% of available tests. The printer system (all elements of the transmission path, including the transmitter and associated receivers) must be able to: Print copies of the laboratory reports Operate in a "normal" medical center-operating environment without additional expense for air conditioning, humidity control, or noise suppression Provide reprint capability of a report at the VA laboratories. The Contractor shall: Be responsible for preventive and as-needed maintenance or replacement of the printer, PC (personal computer), and all associated devices Have the responsibility to train medical center personnel in routine operations (loading and unloading paper, ribbon changes, test and reset); and Provide a validation service (fax or telephone) in the event of transmission or printer degradation. The Contractor shall provide upon a mutually acceptable implementation date, at no cost to the Government, an electronic interface capability (bi-directional) system, herein referred to as EFC-bd. Computer requirements shall include, but not limited to host to host allowing electronic order entry, inquiry, i.e., test status, results, specimen handling requirements, test methodologies, etc., and automatic transmission of out-source reference testing into the VA s current legacy of the veterans health information systems and technology services, hereinafter referred to as VISTA. Upon implementation of electronic interface capability (bi-directional) the Contractor will have sixty (60) calendar days to establish a working interface software program at the VISN 4 facilities. Compliance will depend as well and will be directly related to the VISN 4facilities readiness and commitment for implementation. Contractor shall provide all necessary implementation support for interface configuration. EFC-bd is based on Health Level System (HL7) Version 2.3 messaging protocol and VISTA Laboratory HL7 specifications document. This document should be used as a basis for data interchange. EFC-bd will provide electronic data interchange between the VISTA Laboratory package and other VISTA and non-VISTA laboratory information systems for the transmitting and receiving of laboratory test orders, order processing and results reporting. The contractor shall provide the needed labor resources to establish the EFC-bd in both VistA Laboratory Package and the Contractor s Information System. This includes configuring the HL7 connection and test code mapping in both VistA and the contractor s information system for the tests listed in Attachment A. Any additional tests needed to be mapped or interfaced will be supported by the contractor. VISN 04 facilities will construct shipping lists on VISTA listing specimens, tests, and other information to openly identify the shipment. These facilities will also have the capability to transmit electronic messages containing those tests being transported to the receiving Contractor facility. The electronic transmission of orders will include shipping information to enable VISN 04 facilities and the Contractor to have shipping information prior to arrival. These orders will be stored in a pending orders file, pending specimen/shipping list arrival. The Shipping List will have complete information to allow manual order entry at the referral site, if required. Required information will include: Name of shipping facility Shipping List ID Shipping date/time Referring point of contract Method of shipment for example, carrier, bill no., estimated time of arrival, etc. (if other than the reference lab courier) List of tests with patient demographics similar to VISTA load/worklist Bar code site and specimen ID on shipping list and specimen ID labels Automated order entry will also be possible. The receiving facility (Contractor) shall: Process shipments upon arrival using shipping list Accession specimens into computer from pending orders file Update electronic shipping lists with status of specimens, i.e., received, missing, insufficient quantity, incorrect shipping conditions, improper specimen, etc. Store links to referring site/accession for acknowledge of shipment Receipt, status of testing and results transmission to VISN 04 facilty and update workload, as appropriate Construct electronic messages containing test results and return to VISN 04 facility. Upon receipt of tests, the VA will update the order/accession with test results and allow either automatic release or provide for review before release as well as update workload. Provide documentation of successful interfacing with a minimum of 2 VA references (not within VISN 4) and 2 private sector, other federal agency, state or local government agencies/ institutions. References to include the facility address, telephone number, email address, and contact person s name which can validate past experience within the last three (3) years Maintenance of Automated System: The Contractor shall provide preventive and as-needed maintenance on the terminal system at the VA facility/clinic at no additional charge to the government. The Contractor shall provide maintenance within 24 hours of notification by the POC or designee. In the case of a failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, fax, or courier service) to VISN 04 facilities, and shall maintain the same time frames as the automated system. In the case of an emergency due to computer malfunction, the Contractor will provide a contingency system to provide a hard copy to VISN 04 facility. The hardware will be placed in a location designated by the VISN 04 facility and maintained according to the criteria specified in 4.11.7 above, with the following additions: Contractor will provide telephone service in the event of transmission or printer degradation Contractor will be responsible for the installation and, if and when necessary, the removal of all telecommunication equipment. This will take place a mutually agreed upon time between VISN 04 facility and the Contractor Hardware(s) that is/are used for storing laboratory data should be sanitized prior to removal from the Clinical Laboratory. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT The Contractor shall be subject to Quality Assurance measures, using the standards as outlined in this PWS and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted. The Government will evaluate the Contractor s performance to ensure services are performed in accordance with this Contract to include monitoring test results for consistency to ensure results correlate with diagnosis. If any of the services do not conform to the contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no additional cost to the Government. When the defective services cannot be corrected by re-performance, the Government may: Obtain the service from another source and charge the Contractor with any resultant charges plus actual administrative costs. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and Take other actions as appropriate, including but not limited to termination of this Contract. For contracts with a period of one year or less, the CO will perform a single evaluation when the contract is complete. For contracts exceeding one year, the CO will evaluate the Contractor s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor s designated representative for comment. The Contractor will have sixty (60) days to submit any comments and re-assign the report to the CO. Failure of the Contractor to respond to the evaluation within those sixty (60) days will result in the Government s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor s representative will be locked out of the evaluation and may no longer send comments. The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency (RA). The Contractor shall advise the POC of any changes in methodology, procedure, reference ranges, delays in testing, and any new tests introduced within a timely manner and prior to changes being made. In the event that the Contractor changes the assay procedure of a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the Contractor shall notify the POC prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes and LIONC coding. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO/POC. If it is deemed that the removal of the test from the test menu is required, due to any changes by the Contractor, then it will be communicated to the Contractor by the CO, POC or designee. To ensure proper handling and test performance, the Contractor shall provide the following updated information to VA upon request during the life of contract: Indication of average monthly volume of specified tests in the Schedule that the laboratory performs. Quality control statistics of all tests or specified tests performed for the VISN 4 facilities. Proficiency testing data shall include a list of tests outside of the acceptable range for past two years. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites. The Contractor(s) facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government upon prior written notice and during normal business hours during the life of the contract. SPECIAL CONTRACT REQUIREMENTS SUBCONTRACTING: If during the course of the Contract, the Contractor elects to subcontract to a different laboratory for the purpose of performing any of the services required under this Contract, the Contractor shall provide advance written notification to the CO and POC. The Contractor shall be responsible for ensuring that subcontractor possess and maintain the same qualifications, accreditations and certifications as required for the Contractor as described above. The contactor will provide copies of qualifications upon request to POC or designee. The contractor is responsible for invoicing and fulfilling the terms of the Performance Work Statement. The subcontractor should not invoice for services under this contract. RECORDS: The Contractor shall be responsible for creating, maintaining and disposing of only those government required records that are specifically cited in the work statement or required by the provisions of a mandatory directive listed in section (d) Applicable Publications and Forms. If requested by the POC, the Contractor shall provide the original record, or a reproducible copy of any such record, promptly of receipt of the written request. If the Contractor is sending samples to a Subcontractor, sample integrity must be ensured during the entire transport process. Subcontracting shall not cause the loss of sample integrity due to transportation conditions or distance. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. PATIENT LISTS: The Contractor shall treat patient lists, no matter how developed, as privileged information. Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the VA without prior written permission by the POC or Chief of Staff. RELEASE OF MEDICAL INFORMATION: The Contractor and its subcontractors shall not release any medical information obtained during the course of this contract to anyone outside the VA, unless authorized in writing by the POC and the patient, as required by applicable law. PROFESSIONAL LIABILITY INSURANCE: Professional liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Insurance Certificate upon receipt of a written request by VA. SAFETY: The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required. END OF CONTRACT PERFORMANCE: At the end of the period of contract performance, The VISN 4 facilities will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractor-provided equipment shall be disconnected by the Contractor from The VISN 4 facilities upon contract expiration and removed within five working days. GOVERNMENT RESPONSIBILITIES OVERSIGHT OF SERVICE/PERFORMANCE MONITORING: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: VISN 04 facilities will provide laboratory specimens prepared according to the Contractor's laboratory user s manual, identified, and labeled for testing. The Contractor shall be responsible for transporting and storing specimens according to industry standards. Contractor shall supply any special preservatives required for specimen preservation. VISN 04 facilities are responsible for packaging the specimens for transport. CO RESPONSIBILITIES: The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity, or quality of performance of this contract. The CO shall resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract. POC RESPONSIBILITIES: After contract award, the CO will designate a VA employee as the Point of Contact (POC). The POC will be responsible for overseeing the services performed by under this Contract. The POC shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the CO. The POC will certify monthly invoices for payment and will be responsible for monitoring the Contractor s performance to ensure all specifications and requirements are fulfilled. BILLING/INVOICES The VISN 4 facilities will maintain a record-keeping system comprising daily logs specimens sent to the Contractor for processing. The POC will review this data against monthly invoices submitted by the Contractor to ensure invoices accurately reflect the services performed. Payment made during all periods of performance of this agreement shall constitute the total cost for services rendered by the contractor, and shall not exceed the amounts specified in the Schedule of Supplies and Services without written request and the written approval from the CO. Invoices rendered by the contractor to The VISN 4 facilities for services furnished under this agreement, will be invoiced in full for each month in which services were performed. All payments made under this contract will be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized. Invoices shall be electronically sent, using the form Tungsten/OB10 e-Invoice, to the Department of Veterans Affairs, PO Box 149971 Financial Services Center (FSC), Austin, Texas 78714-8971. For more information on how to send invoices electronically, visit http://www.ipps.fsc.va.gov. All invoices applicable to this contract must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the POC At a minimum, each invoice must contain the following: Dates of service, description of test(s) performed, unit price, and total cost of services provided, purchase order number, contract number, and remittance address. All invoices must include the name, title and phone number of person to be notified in the event of defective invoicing. Refer to FSC policy in completing and submitting Form OB-10 e-Invoice. All invoices must be submitted for actual services performed by the Contractor. Invoices shall be submitted in accordance with, and at the prices specified in the continuation of SF Form 1449, Schedule of Supplies and Services of this agreement. Invoice requirements and supporting documentation: Supporting documentation and invoices must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a proper invoice in accordance with FAR 52.212-4 (g), all invoices must include all information necessary using electronic means in accordance with the policy set forth by the VA Financial Services Center, Austin, Texas (see previous paragraph). A.1 SAMPLE PRICE SCHEDULE Note: This is just a sample price schedule to showcase the Monthly Firm-Fixed Priced CLIN and subsequent information SLINs. Any resultant solicitation, when based on this pricing methodology, will include all nine VA facility CLINS and all the potential tests as information SLINs underneath each CLIN (refer to full test listing attachment to this Source Sought Notice). ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 12.00 MO $_______________ $_______________ Monthly charge for Reference Laboratory Testing Services IAW the PWS and test listing, and historical annual quantities For Altoona Pricing/Ordering Period POP Begin: 11-01-2023 POP End: 10-31-2024 0001AA 1.00 EA $_______________ Zonisamide(Zonegran), Serum Liquid Chromatography/tandem mass spectrometry (LC/MS-MS) 80203 0001AB 1.00 EA $_______________ Zolpidem, WB 80368 0001AC 1.00 EA $_______________ Typhus Fever Group IgG & IgM Immunofluorescence 86757 (x2) 0001AD 1.00 EA $______________ Triglycerides Enzymatic 84478 GRAND TOTAL $______________
