VISN Wide Gremline Genomic Testing Multiple Award BPA
Added: Sep 12, 2017 3:56 pm Page 1 of 16 Page 1 of 16 COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Document Title: VISN 19 Germline Genetic Testing Solicitation Number: VA259-17-Q-1045 Posted Date: September 12, 2017 Original Response Date: September 18, 2017 Current Response Date: September 18, 2017 Classification Code: Q Set Aside: Small Business NAICS Code: 621511 Contracting Office Address Department of Veterans Affairs Network Contracting Office NCO 19 6162 S. Willow Dr., Ste 300 Greenwood Village, CO 80111 Place of Performance VISN 19 Medical Centers - Delivery will be detailed on Call Orders: Rocky Mountain VA Medical Center, Denver Colorado Cheyenne Wyoming VA Medical Facility Grand Junction Colorado VA Medical Center VA Montana Health Care System VA Salt Lake City Utah Health Care System Sheridan Wyoming VA Medical Center Oklahoma City Oklahoma VA Health Care System Muskogee Oklahoma VA Medical Center Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular FAC 2005-95 01/19/2017. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $32.5 Million. The Department of Veterans Affairs (VA) Veterans Healthcare Administration (VHA), has a requirement to secure the service of contractors able to perform specific specialized germline genetic tests within their organization that are required for critical laboratory analysis and result interpretation for veterans patient care. The purpose of this acquisition is to provide VHA with Multiple Award BPAs for the services listed in the Statement of Work. This will ensure that the VA medical centers within VISN 19 have multiple established resources readily available and to prevent future emergency requests, thus decreasing the possibility of delays in patient care. The BPA holder shall provide written notice to the VHA Contracting Officer, of any changes that impact the BPA and services provided, specifically to any items on this resultant BPA. Changes include, but are not limited to, price decreases, product or service deletions, CPT code changes, and/or exchange in vendor company information, including contract administrator, company name, address and phone number. 1. PERIOD OF AGREEMENT: This BPA will be established for a one year (12 month) ordering period. 2. EXTENT OF OBLIGATION: The Government is obligated only to the extent of authorized purchases made under the resultant Call Orders. This BPA does not obligate any funds, nor is the Government obligated to make any purchases under this BPA. The Government does not guarantee any volume of purchases tough a BPA. The terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the BPA Holder s invoice, the provisions of this BPA will take precedence. 3. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA: Any individual who has contracting authority, on behalf of VHA, may place orders against this BPA. 4. ORDERING/INVOICING: Orders will be placed against this BPA via Electronic Data Interchange (EDI), via facsimile, in writing, or by phone. Each individual BPA Call Order will describe the tasks, services and deliverables required. Each new Call Order placed under this BPA will be the result of a streamlined ordering process which includes a request for quotation (RFQ). Unless otherwise agreed to, all deliveries under this BPA must be accompanied by delivery tickets or sales slips that must contain the following information at a minimum: a. Name of Contractor b. BPA Number c. Call Order Number d. Purchase Order Number e. CPT Number/Description etc. f. Date of Order g. Quantity, Unit Price, and extension of each item (unit prices and extensions need not be shown when incompatible with the use of automated system if the invoice is itemized to show the information); and h. Date of Shipment BPA ordering will be decentralized. Orders will be placed by field offices directly under the BPA. Invoicing, acceptance, and payment shall be in accordance with the instructions provided in each individual Call Order. All Orders shall be placed on a Firm Fixed Price basis. Ordering Procedures are in accordance with FAR 13.303. All requirements under the BPA will be issued on competitive basis. Any individual order not exceeding $2,500.00, any VHA VISN 19 Government Purchase Card holder may place the order and use their credit card as a form of payment. 5. DELIVERY: Authorized personnel from VISN 19 VA Medical Centers may request delivery on placed orders. Each BPA Call Order will list the station Point of Contact (POC) authorized to schedule deliveries. The POC will be responsible for technical monitoring of the contractor s cost per test reporting and will interpret specifications or technical portions of the work. The POC is not authorized to perform, formally or informally, any of the following actions: (1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract; (2) Waive or agree to modification of the delivery schedule; (3) Make any final decision on any contract matter subject to the Disputes Clause; (4) Terminate, for any reason, the contractor's right to proceed; (5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action. The contractor shall immediately notify the Contracting Officer in writing if the POC has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations. The contractor shall provide the Contracting Officer information copies of all correspondence to the POC. 6. REPORTS: Not Required 7. CANCELLATION: This BPA may be canceled if the BPA holder fails to perform in accordance with the terms and conditions of this BPA, any order established under this BPA, or if deemed as in the best interests of the Government. 8. ORDER OF PRECEDENCE: Where delivery terms, FOB terms, or ordering requirements have been modified by this BPA, those modified terms will apply to all purchases made pursuant to it and take precedence. 9. AUTHORIZED LIMITS: The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $150,000.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $600,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated tough the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed tough the ratification process. 10. FEDERAL HOLIDAYS: Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below outside of on-call availability detailed below. New Year s Day Labor Day Birthday of Martin Luther King, Jr. Columbus Day Washington s Birthday Veterans' Day Memorial Day Thanksgiving Day Independence Day Cistmas Day 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. All interested offerors shall provide a test menu price list for the following: CLIN Line Item Description Quantity Unit Price Total Price 0001 Germline Genetic Testing Services as Per BPA Price List. Contract Period: Base POP Begin: 9-25-2017 POP End: 09-24-2018 1 LT N/A N/A STATEMENT OF WORK (SOW) The contractor(s) shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to services as defined in the requirements of the SOW except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract and maintain compliance with policies and procedures with the Health Insurance Portability and Accountability Act (HIPAA) and Clinical Laboratory Improvement Act (CLIA) and the College of American Pathologists (CAP) standards. The contractor s laboratory shall provide testing and have the ability to perform analysis for single genes or site specific (targeted) mutations, pre-curated test panels, combine multiple tests, and provide the ability to reflex to additional genes within the original clinical domain with the same biospecimen. These services require a CAP-certified, CLIA-accredited laboratory with the ability to perform a wide menu of genetic testing. VHA Genomic Medicine Service (GMS) Salt Lake City will not be required to use pre-created multi-gene panels that analyze genes not needed by the providers. For specialized testing, GMS will provide a clinical history when necessary. For site-specific mutation testing, GMS will provide a copy of a previous family member s test result, when available. Variant of unknown significance (VUS) evaluation and family studies will also be available when necessary. Testing Required: GMS seeks to contract with multiple different laboratories that can process the majority of our testing requirements. One contractor is not expected to be adequate. Since the laboratory testing field is dynamic, when a new test or panel of tests is released, GMS will have access to that offering without amending the contract. GMS germline genetic testing may be ordered in diagnostic areas for adult conditions and include, but are not limited to: cancer, cardiovascular, neurological and neuromuscular conditions, mitochondrial conditions, metabolic conditions, ophthalmology, endocrine disorders, renal disorders, immunologic disorders, rheumatologic disorders, skeletal disorders, and preconception/prenatal screening. Contractor Requirements: The contractor must also provide a VUS evaluation program. This will include a description of the lab s approach to bioinformatics related to VUS classification, the reclassification process, and the process for family testing. The contractor must provide the following services: (a) Provide the following for transport of the specimens to include: Lab test request forms (it is possible that vendor may need to customize forms to include information required by the VA). At minimum: GMS provider data Patient data full name date of birth social security number or a second identifier gender test(s) to be performed sample collection date/time sample type Special instructions for handling of specimen Description of sample types that can be accepted for each test Specimen collection supplies for specialized testing. Mailing account number to cover the costs of shipping with in the US. (b) Analyze samples. (c) Provide a monthly bill for tests completed each month following the month in which the service was delivered. (d) Consultation service with VA Laboratory on test results by telephone as needed. (e) Means of communication to permit immediate inquiry regarding the status of a pending test. (f) A Laboratory User s Manual or similar documentation. The manual shall include a list of all tests that the Contractor can provide along with the testing methodology used for each test, turn-around time for each test, days the test is run, and specimen requirements and any special handling required. The VA Laboratory reserves the right to request the results of any proficiency testing that the contractor subscribes. The Contractor Laboratory shall: Perform testing services entirely upon their premises listed on their response. Accept and store the National Provider Identifier (NPI) for GMS staff members. All are licensed healthcare providers, including genetic counselors, nurse practitioners, and physicians. All of these licensed professionals within the VA have it within their federal scope of practice to independently order germline genetic tests. Accept orders without requiring additional signed consent forms beyond a provider s attestation on the test requisition form. Provide a list of tests currently available with a price list. Perform analytical testing for VAMC patients for the tests requested. The Contractor shall bill only for the tests specified in the request sent by GMS laboratory service. An acceptable VUS evaluation program or family studies program will be provided with no additional billing to GMS or patient. Provide a reference test manual and report of analytical test results, upon award, describing the full scope of its laboratory operations. Provide VA GMS with laboratory supplies (collection tubes, transport packaging, etc.) not customarily utilized by VA GMS. These supplies are to be used by VA GMS only in connection with specimens being sent for testing to the contractor. Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. Provide test result by fax or electronically to GMS in an encrypted fashion compliant with VHA requirements. Contact information to be provided upon contract award. Assign a specific local account representative. Make available a genetic counselor to consult with VA GMS on test results by telephone, as needed, during regular business hours. Provide telephone number(s) and contact person(s) to be used by GMS to make specimen problem inquiries and problem solving on weekdays. If requested, provide publications that support their testing and interpretation decisions. *NOTE: Also, include names and telephone number(s) of Technical Directors and Pathologists available for consultation. 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. Advise GMS of any planned changes in methodology, codes, or new procedures at least 14 days prior to changes. In the event that a two week notification is not possible due to an emergency, contractor shall notify GMS as soon as possible. Do not release patient s records that include test results to anyone other than the ordering healthcare provider, to include VA Medical Center where the biospecimen collection originated and GMS staff. All records shall be treated as confidential, so as to comply with all state and federal laws regarding the confidentiality of patient s records. This provision shall survive termination of the resulting contract award. Certify and ensure that all employees, officers, or agents comply with standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). Test Sample Preparation The VA laboratories shall be responsible to provide laboratory specimens prepared in accordance with the contractor s Laboratory User s Manual. All specimens will be properly identified and labeled for testing. The contractor shall provide an adequate supply of requisition forms, special instructions, and a current list of tests with specimen requirements. These requirements shall be defined in the laboratory user s manual. Transport of Specimens Client Services will provide mailing account number to GMS to send samples directly to contractor s laboratory. Reporting of Test Results A report is defined as a printed final copy of pathology interpretive consult. Consult reports shall be sent by contractor electronically or by fax to the ordering Laboratory. If results are telephoned prior to sending, the written report must include the name of the individual notified of the results, date and time of telephone report. Each report shall at a minimum indicate the following information: Patient s full name and identification code Patient s date of birth Patient s full social security number or unique hospital identification number Provider s name and GMS account number (e) Test(s) ordered (f) Date/time of specimen collection (when available) (g) Date/time specimen received in Reference Lab (h) Date test completed (i) Type of specimen/source (j) Test result(s) (k) Flag abnormal results (l) Name of testing laboratory (contractor and/or subcontractor), address, CLIA number (m) Testing laboratory specimen number (n) Type of specimen (o) Comments related to the test provided by the submitting lab (p) Information that may indicate a questionable validity of test result (q) Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing Licensing and accreditation Contractor Laboratory shall: Have all licenses, permits, accreditation certificates required by Federal law and State law. Be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) and the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory s Laboratory Director(s) and/or Medical Director(s). Medical Director(s) shall have suitable Molecular Genetics qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards. Have personnel assigned to perform the services covered by the contract who are eligible to provide these services and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on the 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. Comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS). 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. Notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. Upon award, provide an electronic Laboratory Manual to GMS containing: Department hours of operation Accreditation Technical Staff Service Departments (Method of contacting, phone numbers, hours of availability) Quality Control and Quality Assurance Information Billing Procedures & fee schedules for services provided Procedures and criteria for phoning reports and other important information Quality Control: The contractor shall operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with the requirements stated. The quality control program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract. The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required for performing the type of services described. Hours of Operation: The contractor is responsible for providing services 8:00am 5:00pm Mountain Time Monday Friday, except for Federal Holidays. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within the requirements. When hiring personnel, the Contractor shall hire in a manner congruent with the established stability and continuity of the workforce. Contractor Furnished Items and Responsibilities: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work as outlined in this contract. Periodic reporting: Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to GMS Salt Lake City laboratory staff and the administrative officer. The reports shall be in Microsoft excel format and include at minimum the following column headers: patient name, date of service, CPT code, test name, procedure, volume, cost per test, total cost, and test turnaround from accessioning to reporting date. These reports shall be available within 30 days after the end of the quarter. Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided to the contractor laboratory. IT Security: The C&A requirements do not apply, a Security Accreditation Package is not required Privacy Act: The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or tough 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 or disclosure is required by law. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. 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. HIPAA Compliance: The 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. Designation of Contract Representatives: BPA Call Orders will designate the Contracting Officer Representative (COR) or Point of Contact (POC) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. Each facility will also have an appointed COR/POC 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/POC designation will be provided. Information from the facility COR/POCs will be forwarded to the VISN 19 Contracting Officer or Contract Specialist who will monitor the overall performance of the contract. The delivery period of performance is: Base 9/25/17 tough 9/24/18 Award shall be made to the offeror whose quotation offers the best value to the government, considering price. The government will evaluate in accordance with FAR 13 and FAR 52.212-2; Past Performance and Price. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html or http://farsite.hill.af.mil/. The following solicitation provisions apply to this acquisition: FAR 52.209-5, Representation by Corporations Regarding an Unpaid Tax Liability or a Felony Conviction under Any Federal Law (Mar 2012) (Deviation). FAR 52.212-1, Instructions to Offerors Commercial Items (Jan 2017) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (Jan 2017) VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (Jul 2016) (Deviation) Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (Jan 2017) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (Jan 2017) The following subparagraphs of FAR 52.212-5 are applicable: Subparagraph (b)(1), (b)(2), (b)(4), (b)(6), (b)(7), (b)(8), (b)(9), (b)(25), (b)(27), (b)(28), (b)(29), (b)(30),(b)(31), (b)(32), (b)(33), (b)(34), (b)(35), (b)(42), (b)(48), (b)(54), (b)(57), (c)(1), (c)(2), (c)(4), (c)(8). FAR 52.212-8. Option to Extend Services (Nov 1999) FAR 52.224-1, Privacy Act Notification (Apr 1984) FAR 52.224-2, Privacy Act (Apr 1984) FAR 52.232-19, Availability of Funds for the Next Fiscal Year (Apr 1984) FAR 52.237-3, Continuity of Services (Jan 1991) VAAR 852.203-70, Commercial Advertising (Jan 2008) VAAR 852.215-71, Evaluation Factor Commitments (Dec 2009) VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2012) VAAR 852.237-7, Indemnification and Medical Liability Insurance (Jan 2008) VAAR 852.237-70, Contactor Responsibilities (Apr 1984) VAAR 852.246-71, Inspection (Jan 2008) VAAR 852.271-70, Nondiscrimination in Services Provided to Beneficiaries (Jan 2008) All offerors shall submit the following: (1) copy of the test menu price list completed with unit price, (1) copy of technical capability statement, (1) copy of 52.209-5, Representation by Corporations Regarding an Unpaid Tax Liability or a Felony Conviction under Any Federal Law filled out (attached for convenience), and provide their DUNS. All quotations hall be sent via email to Sura-Quay.Arbon@va.gov. This is an open-market combined synopsis/solicitation for services as defined herein.  The government intends to award a BPA as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Offeror shall list exception(s) and rationale for the exception(s). Submission shall be received not later than September 25, 2017 at 1500 MST at via email to Sura-Quay.Arbon@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist Sura-Quay Arbon at Sura-Quay.Arbon@va.gov. Point of Contact Contract Specialist Sura-Quay Arbon at Sura-Quay.Arbon@va.gov. Attachments
VA25917Q1045 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19
9/12/17, 3:56 PM