Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

?.## PERFORMANCE WORK STATEMENT VETERANS INTEGRATED SERVICE NETWORK (VISN) 10 BATTLE CREEK & WYOMING CBOC REFERENCE LABORATORY TESTING SERVICES Overview The Contractor shall enter into an Indefinite-D... ?.## PERFORMANCE WORK STATEMENT VETERANS INTEGRATED SERVICE NETWORK (VISN) 10 BATTLE CREEK & WYOMING CBOC REFERENCE LABORATORY TESTING SERVICES Overview The Contractor shall enter into an Indefinite-Delivery Indefinite Quantity Contract (IDIQ) with the Battle Creek VAMC and Wyoming CBOC in Michigan to provide reference laboratory testing for the patients enrolled in the participating facilities. Contractor shall provide all necessary supplies to provide reference laboratory testing services for the participating facilities below and all support facilities of the BCVAMC. The IDIQ term shall be five (5) years. This is a firm-fixed price IDIQ. The estimated quantities are for each test per year. Background Department of Veterans Affairs, Veterans Health Administration (VHA), VISN 10, Battle Creek VAMC and Wyoming CBOC, requires the services of a contractor for reference laboratory testing services. The contractor shall provide reference laboratory testing for the patients enrolled in the participating facilities. Contractor shall provide all necessary supplies to provide reference laboratory testing services for both the participating facilities below and all support facilities. Reference Laboratory Services include at minimum specimen preparation and storage; transportation of clinical laboratory specimens; microbiology cultures and stocks; performance of analytical testing; reporting of analytical test results; consultative services; and reports as required by this document. Places of Performance Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek, MI 49037 USA AND Wyoming VA CBOC 5838 Metro Way SW Wyoming, MI 49519 USA SUPPORTING FACILITIES Contractor shall ensure that supplies are provided as required by the Veterans Affairs Medical Center (VAMC). A VA courier will collect specimens from support facilities and those specimens will be collected by the contractor courier from their assigned participating facility on the dates and times listed in Section 5 below. Government reserves the right to add or remove supporting facilities as necessary. CONTRACTOR RESPONSIBILITIES OVERVIEW The Contractor shall provide at minimum: All necessary supplies for specialized specimen collection, testing, transport, and packaging, shipping kits Supplies shall be provided as the medical centers require additional supplies to support patient testing needs. (Government will provide Serum 2 supplies) Courier (not shipping) and flight services for the transportation of the specimens Flights to be made out of an airport that provides the best efficiency in getting the specimens to the contractor while maintaining specimen integrity. Contractor is responsible for specimen integrity once specimen leaves the VA facility. Courier service for pick-up of patient samples from facility s laboratory, shall be provided Monday Saturday and pick-up times required by the site are identified below: Battle Creek VAMC 1 pickup Mon-Sat between 6:00PM and 7:00PM Wyoming CBOC VAMC 1 pickup Mon-Sat between 6:00PM and 7:00PM Dry ice (if required) Chain of custody forms (if required) Specimen transport request forms Reference laboratory testing and reporting with current reference ranges. Secured web-based portal system, Intranet Laboratory Electronic Data Interchange (LEDI) system, and printer equipment including compatible ORACLE EHRM equipment. Contractor must have interchange with the VA EHR computer system which will be installed during this contract at the time of award. Contractor shall have a single national coding system. Contractor shall utilize one test code per test nationally. Contractor shall utilize approved Patient Identifiers Customer telephone service 24/7 365 days a year Contractor shall have an electronic test menu submission system as the preferred test submission avenue with limited specialty tests to be submitted on paper test submission forms. Shipping manifest Monthly report to the VAMC to include, at a minimum, through an appropriate electronic format: (no PII/PHI can be included) Tests ordered. Number of unsatisfactory specimens Number of tests performed in current month; and Calendar year-to-date with Current Procedural Terminology (CPT) code and cost. Reports to include all testing ordered for the calendar year. This report shall include pricing per account number for each participating site. Provide and maintain a user-friendly public website which allows easy reference for researching test information (test number/CPT coding, patient preparation, test utility, result interpretive guidelines. For tests not listed on public website Contractor shall provide access to their database for client research test information; and Routine test results to the participating ordering facility within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results shall be provided the following business day). The Contractor shall notify the facility within two (2) hours of any critical values or results. Contractor s billing and utilization reports shall run from the first day of each month through the last day of each month. For Example: January 1 January 31, February 1 28 or 29(if leap year), and June 1 June 30. QUALIFICATIONS Licensing and Accreditation Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor/Subcontractor shall have all licenses, permits, accreditation and certificates required by law and be provided to the CO/COR at the time of award. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP) or The Joint Commission (TJC), or any other licensing and/or Accreditation in order to perform the required testing listed in this PWS. 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 (CLIA). 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 contract award. In addition, the Contractor shall be responsible for providing written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award and as requested by the Contracting Officer (CO). All proposed Subcontractor changes during the contract performance period must have prior approval by the CO. Changes to the requirements shall be addressed by bilateral modification. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract 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 contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA) 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 contract 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 access via website or email upon request a copy of the renewed licenses/certificates before expiration. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. The Contractor must have at least three years of experience providing laboratory services and must have at least one-year experience in transporting biomedical materials. CLIA certifications shall include approval for testing for the following disciplines/subdisciplines and effective dates of approval for each disciplines/subdisciplines Histocompatibility (010) Bacteriology (110) Mycobacteriology (115) Mycology (120) Parasitology Virology (140) Syphilis Serology (210) General Immunology (220) Routine Chemistry (310) Urinalysis (320) Endocrinology (330) Toxicology (340) Hematology (400) Immunohematology ABO Group & Rh type (510) Immunohematology Antibody Detection (transfusion) (520) Immunohematology Antibody Detection (non-transfusion) (530) Immunohematology Antibody Identification (540) Immunohematology Compatibility Testing (550) Histopathology (610) Oral Pathology (620) Surgical Pathology Molecular Biology Cytology (630) Radiobioassay (800) Cytogenetics (900) Any changes to the CLIA certifications should be communicated to the facility within 24 hours. This also applies to the subcontractors. The Contractor is required to provide all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award. The Government reserves the right to refuse the use of a subcontractor who fails to comply with evidence of accreditation(s) or licensures(s) SPECIMEN PREPARATION Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. If a medicolegal 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 ensure the integrity of the specimen. SPECIMEN TRANSPORATION Contractor shall provide transportation of primarily biomedical materials that include patient specimens, cultures, and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These specimens 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. Transportation/Courier Services for pick-up of patient samples from the Government facilities listed in this document shall be provided by the contractor. The Government reserves the right to adjust the courier pick-up days and times as necessary, provided a two-week notice has been provided and acknowledged by the Contractor at no additional charge to the Government. The Government reserves the right to add or remove courier pick-up locations provided a two-week notice has been provided and acknowledged by the Contractor at no additional charge to the Government. Processing shall begin immediately upon receipt at the testing site and results provided within the laboratory established turnaround times. Courier services shall be available seven (7) days a week, including Federal holidays as required. A list of Federal Holidays can be found in the following Link: Federal Holidays (opm.gov) Contractor shall provide all necessary supplies for biomedical materials to be transported from the VA medical facility to the performing laboratory. These supplies shall include at minimum: 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.). Printer and printer supplies including paper, labels, and toner/ ink cartridges, in sufficient quantities to perform work under this contract. SPECIMEN TESTING Contractor shall ensure test sample integrity is maintained at all times from the time they are picked up from the participating facility and delivered to the processing laboratory. Contractor shall provide the full range of laboratory testing capabilities to execute all required test orders as annotated in this agreement. All the testing should be performed on the Contractors premises or within the Contractor s network labs (as official or qualified subcontractor). Under no circumstance should the contractor allow any patient information to cross the US borders. Contractor referral to the secondary laboratory or subcontractor should be kept to a minimum for control and uniformity purpose. Subcontractor should be held to the same quality standard as specified in the contract. Contractor shall make available the following test information: Requisition form requirements Alphabetized test name list Test order code Specimen collection and preservation requirements Test method employed (indicate if testing performed in duplicate) and interpretations Test reference intervals adjusted for age, sex, or race, when required Test specific sensitivity, specificity, and interferences, when required Result code Test critical values if any Policy for critical value notification CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by a government facility. Schedule of test performance (specific days of week indicated) Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab, name, and address of secondary (sub-contracted) laboratory must be cited) Contractor shall notify the Site Contracting Officer Representative (COR) for each participating facility of any test submitted to be processed that does not match this agreement prior to being tested so that the appropriate process can be followed to process the test. All reference laboratory testing is preferred to be tested using test methods that 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. Contractor shall ensure the accurate and timely performance of laboratory testing services on all tests within this agreement. SPECIMEN RETENTION 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. TEST RESULTS & REPORTS Test Results: If the Contractor is unable to perform the test due to issues with the specimen integrity, the Contractor shall inform the VA as soon as possible, via email to the designated COR, with a maximum time of 24-hours of receipt of the specimen. Once testing is completed, the laboratory results shall be transmitted via secured web-based portal system or the LEDI system to each participating facility via VAMC VISTA/CERNER computer system and printer equipment provided by the Contractor that will be located at each participating facility. Alternate methods of reporting results in the event of electronic system failure may include: Electronic delivery of all reports is preferred. Faxed, please verify fax number prior to sending patient results as fax numbers are subject to change: 269-966-5483 All test results provided by the Contractor/subcontractor shall contain at minimum the following: Two (2) full patient identifiers, one of which is patient s full name Physician s name Testing facility name and address Clinical Laboratory Improvement Amendments CLIA number (if requested) Account number Date/time specimen was collected Date/time specimen was received Date/time test was reported Contractor generated Laboratory Accession Number VA generated Laboratory Accession Number Test ordered Test result Flagged abnormal results Reference ranges Type of specimen Any additional comments related to test provided by submitting lab Any other information the laboratory has that may indicate a questionable validity of test results; and Unsatisfactory specimens shall be reported with regard to its unsuitability for testing. Corrected reports shall be issued in accordance with accreditation requirements. The Contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies of original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the facility or clinics at the same time the Contractor submits the final reports. The Contractor shall prepare additional blocks and slides, in quantities specified by the facility for review by pathologists. For malignant cases, the Contractor shall call results to the submitting facility, and prepare paraffin blocks and slides for review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO). For benign cases, the Contractor shall prepare slides for review by the facility. Upon provision of sample slides by the facility, the Contractor shall provide interpretation of sample slides. The sample shall include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology. The Contractor shall store all blood and fluid specimens after all testing has been completed in the event repeat or add on testing for one (1) week at conditions that shall maintain sample viability. Upon request, samples shall be returned to the collecting VA facility via courier at conditions that shall maintain sample viability, at no additional charge to the VA. All anatomical pathology specimens (i.e., slides, blocks, etc.) shall be returned within two (2) weeks of test completion. Reports: All Reports shall run from the 1st day of each month through the last day of each month. For Example: January 1 January 31, February 1 28 or 29 (if leap year), and June 1 June 30. 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 access to online statistical analysis and metrics of the Government facilities test utilization reports to assist in the monitoring of ordering trends and utilization patterns. The contractor shall make recommendations to the facilities on mechanisms to reduce their costs and provide recommendations for improvements in testing and results. Test utilization (number and cost) Trending of test utilization (number and cost) Line graph AND Total number Test utilization by provider 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, the VA and Test Lab generated accession numbers, and the name and address of the testing laboratory (contractor and subcontractor). 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) Additional Administration Requirements / Reports The Contractor shall provide an updated copy of the Excel spreadsheet Reference Lab Invoice Summary to the Contracting Officer, COR by the 10th of the month following the close of the reporting month. The Contractor shall update the quantities of tests invoiced during the prior month in this spreadsheet. Contractor shall provide a monthly listing of any tests listed in Section D, Attachment 2 entitled Price-Cost Schedule - Battle Creek and Wyoming CBOC Reference Labs that 1) are no longer performed by contractor or 2) the test name is updated. The Contractor shall highlight the rows RED in the Excel Spreadsheet Declining Balances Monthly Test Tracker for any test codes that are no longer performed by the Contractor or have updated test names and make a note in the Notes column. These tests will be either removed or updated via a supplemental agreement in accordance with 52.212-4. When invoicing, prior to the test name being updated via contract modification, the Contractor shall reference the previous test code name and new test code name on the invoice. The Contractor shall make all reasonable effort to notify the VA that a test ordered against the contract is not listed in Section D, Attachment 2, in order to avoid an unauthorized commitment. For tests that are ordered that are not listed in Section D, Attachment 2, the Purchase Card Procedures in Section D, Attachment 7 entitled Purchase Card Procedures for VA and Contractor shall be utilized. These procedures include the requirement that the Contractor shall provide an updated Excel Spreadsheet, Purchase Card Transactions, that tracks the test name and/or test ordering code, quantity of each test performed, and proposed pricing. QUALITY REVIEW Contractor shall provide the following: In accordance with VHA Handbook 1106 a 10% retrospective quality management peer review shall be completed. This review shall be completed by a second pathologist on at least a quarterly basis for a minimum of 10% of all surgical pathology cases, fine needle aspirates, cytopathology cases and gynecologic cases. This 10% review shall be performed by a pathologist certified in anatomic pathology. Reviews shall meet these review requirements: Under no circumstances shall a resident physician act as a second reviewer for a staff pathologist. Under no circumstances shall a staff pathologist review a resident physician s diagnosis as this does not constitute a second review. Individuals performing a second review in GYN cytology shall have achieved a current successful GYN cytology competency assessment. The review process shall be random, shall include all types of specimens and shall include a review of the entire case. At least 10% of the cytotechnologist s gynecologic cases that have been interpreted as negative are routinely rescreened and are diagnosed and documented as being negative by a qualified pathologist. Cases subjected for rescreening shall include some cases from high-risk patients, as well as random negative cases, based upon criteria established by the Chief or Director of Pathology and Laboratory Medical Services. Ability to instantly generate reports like cost Management Report, turn-around-time report, Utilization Report and any other quality management report requested by the site. PURCHASE CARD TRANSACTIONS Contractor shall follow the Purchase Card Transactions procedures as directed in Section D, Attachment 7 for any tests ordered that were not originally on the contract. CUSTOMER SERVICE Contractor shall provide customer service including IT support 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 agreement. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address customer services within 24 hours throughout the agreement. Environment of Care: All significant problems identified shall be reported verbally to the COR within 24 hours. A written corrective plan of action shall be submitted to the COR within five (5) working days. VA timeframes and priorities for completion of action plan items shall be mutually agreed upon by the Contractor and the VA Safety Officer. The Contractor shall successfully pass the participating Facility Safety and Infection Control inspections prior to the provision of patient care. VA strives to ensure that the patients experience at each of the medical centers provides for convenience of obtaining all possible tests in one visit Leadership VA Primary Care services and operational activities provided at the participating Facility shall be designed and planned by leadership staff and shall reflect a uniform level of primary care as provided to veterans. The Contractor under the supervision of the PALMS Pathologists shall effectively manage and direct daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VHA. PALMS Pathologists shall provide leadership oversight for improvement of clinical and administrative outcomes. The provision of contracted services shall be described in writing the nature and scope of services provided through contractual agreement. Leaders monitor contracted services by establishing expectations for the performance of the contracted services. Leaders take steps to improve contracted services that do not meet expectations. Personnel Security All Laboratory Directors who manage contractor personnel with direct access to the specimens and data received from and transmitted to the VA are required to complete a background investigation and receive a favorable adjudication from the Office of Security and Law Enforcement. Anyone with administrative or programmer access to a Federal computer system shall have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff. These staff shall be operating within the borders of the U.S.A. and its territories. Continuing Education The contractor shall provide ongoing continuing education material for Professional Acknowledgement for Continuing Education (PACE), Continuing Medical Education (CME) and Continuing Education (CE). DATA MANAGEMENT & CONNECTIVITY REQUIREMENTS Data Management System Contractor shall provide to the Government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Government and the Contractor s database. They shall provide all the IT support required for transition between reference labs, namely building existing and new test codes, test description, interface, troubleshooting and maintenance through the life of the contract. Required test parameters include: Ordering code LOINC code CPT code Interface code Test cost Reference ranges Units of measurement Test result interpretation or interpretive remarks, if appropriate Testing site (if not performed at the vendor s main laboratory facility Test methodology Specimen types Specimen collection and handling requirements Indication whether test is a panel/profile test, list of tests included The parameters for all tests in the Contractor s database shall be kept current and be available to the Government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to Government sites no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor s technical representative to respond to any question(s) regarding the laboratory test parameter information. Contractor shall be approved to be interfaced with ORACLE EHRM and be built at the enterprise level at the time of award. The Contractor shall provide a data management system that meets the following requirements: Test ordering shall be accomplished through a menu that is intuitive, has minimal options, and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test. Test definition, test information, and test requirements must be complete, available and easily accessible. Shipping manifest shall be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered. The status and the results of testing shall be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include: Sort by patient name sort by date; sort by test sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes. Reports of test results must be immediately available upon verification of the test result. Contractor s computer located at the Government site must be able to print test results upon request and reprint retrospective test results. Equipment Security Any equipment provided by the Contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it shall be sanitized prior to removal from the VA premises, shall become the property of the Federal Government and remain on Federal property or shall be destroyed in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning). Data required by the HIPAA to remain on equipment located on Contractor's property shall be safeguarded in accordance with HIPAA and this information shall be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the vendor. VA Connectivity Requirements The Contractor shall provide each participating facility the capacity to order lab testing and receive results through a secure web-based portal. The Contractor shall show that this portal meets VA requirements for encryption of sensitive patient information. The requirements that VA utilizes for these types of transmission shall be the Federal Information Processing Standard (FIPS) Publication 140-2. The Contractor shall be responsible for transmission of orders, confirmation of orders, test results, and the preventive maintenance of the system. Contractor shall be available to train the Facility s staff on the use of the system at each facility. An alterna...