SOLICITATION NOTICE
Q -- (S)(660) Germline Genetic Testing (VA-18-00122363)
- Notice Date
- 8/27/2019
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office;NCO 19;6162 South Willow Drive, Suite 300;Greenwood Village CO 80111
- ZIP Code
- 80111
- Solicitation Number
- 36C25919Q0521
- Response Due
- 9/13/2019
- Archive Date
- 12/12/2019
- Point of Contact
- christy.lee@va.gov
- Small Business Set-Aside
- N/A
- Description
- Page 21 of 26 Germline Genetic Testing for Salt Lake City VA Medical Center, Salt Lake City, UT General Information: Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C25919Q0521 Posted Date: August 23, 2019 Current Response Date: September 16, 2019 Classification Code: Q301 NAICS Code: 621511 Medical Laboratories Set-Aside: Small Business Contracting Office Address: Department of Veterans Affairs Network Contracting Office 19 (NCO 19) 6162 S Willow Dr. Suite 300 Greenwood Village, CO 80111 Place of Performance: Department of Veterans Affairs Medical Center, Salt Lake City VAMC, 500 Foothill Drive, Salt Lake City, UT 84148 Performance Period: The period of performance for the Germline Genetic Testing Services will be a Five-Year Blanket Purchase Agreement. 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 through Federal Acquisition Circular FAC 2019-03 (effective 07/12/2019). The associated North American Industrial Classification System (NAICS) code for this procurement is 621511- Medical Laboratories, with a small business size standard of $35.0. The Network Contracting Office 19 (NCO 19) is seeking to purchase Germline Genetic Testing Services. The purpose of this acquisition is to provide Salt Lake City Veterans Affairs Medical Center with the services listed in the Statement of Work. All interested companies shall provide quotation for the following: PRICE SCHEDULE FOR GERMLINE GENETIC TESTING SERVICES COST PER TEST PLEASE PROVIDE A LIST OF GERMLINE GENETIC TESTING SERVICES AVAILABLE FROM THE CONTRACTORS LABORATORY STATEMENT OF WORK Genomic Medicine Service of the US Department of Veterans Affairs, hereinafter referred to as GMS, intends to secure specialized, off-site referral laboratory germline genetic testing. All services provided shall be in accordance with the costs, terms and conditions of this contract. contract type and term: The VA will award a Firm, Fixed-Price, Five-Year Blanket Purchase Agreement (BPA) commercial services contract for all items listed in the Schedule of Items. Contract use will be available to Genomic Medicine Services, VA Salt Lake City Health Care System. Description of Services/Introduction: 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 Statement of Work (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. Objectives: Genomic Medicine Service (GMS) is a national hub for genetic care within the VHA. GMS provides genetic/genomic care to 80 of the approximate 150 VA facilities and their associated Community-based Outreach Clinics. GMS seeks to obtain genetic testing as described below. Scope: The contractor s laboratory shall provide testing and have the ability to perform analysis for genetic testing. These services require a CAP-certified, CLIA-accredited laboratory with the ability to perform a wide menu of genetic testing. 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. VUS evaluation and family studies will also be available when necessary. Testing Required: GMS seeks to contract with multiple laboratories that can process testing requirements. 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. C&A requirements do not apply, and a Security Accreditation Package is not required 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 bill for tests completed. (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 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 VHMC where the biospecimen collection originated and GMS staff. All records shall be treated as confidential, 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 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 Contract Performance Monitoring: 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 SOW. 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. GMS will maintain an Internal Quality Control Program to monitor the quality of results received from the contractor. The method used for monitoring is at the discretion of GMS and may include, but is not limited to, unidentified split specimens sent periodically to the contractor for analysis, split specimens sent to another reference laboratory for comparison, or monitoring of turn-around-time. 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 GMS during the life of the contract. Quality Assurance: 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 herein and provide that quality assurance plan. 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 SOW. When hiring personnel, the Contractor shall hire in a manner congruent with the established stability and continuity of the workforce. Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided to the contractor laboratory. 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 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. Award shall be made to the offeror(s) whose quotation offers the best value to the government, considering technical capability and price. The government will evaluate information based on the following evaluation criteria, in accordance with FAR 13.106-2 and FAR 52.212-2: (1) technical capability factor meeting or exceeding the requirement and (2) price. Past Performance will be used to determine responsibility. (1) Technical Capability - Submit narrative on the process and procedures on how the company will perform and intend to comply with the requirements as stated in the Statement of Work. (2) Price - The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Quotations that do not meet or exceed the technical capability requirements of the Statement of Work shall not be selected regardless of price. Past Performance If you have Past Performance Information from Contract Performance Assessment Reporting System (CPARS), then Submit most recent and relevant contracts for the same or similar service and other references (including contract numbers, points of contact with telephone numbers and other relevant information). If you do not have CPARS, then use attachment 1: PPQ. Send the PPQ to previous customer and the completed PPQ shall be emailed by the previous customer to Christy lee at christy.lee@va.gov. The full text of the FAR provisions or clauses may be assessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.203-98 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements Representation (Deviation) (Feb 2015) 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 (Oct 2018) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (Jan 2017) FAR 52.216-27, Single or Multiple Awards (Oct 1995) FAR 52.233-2, Service of Protest (Sep 2006) VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (Jul 2016) (Deviation) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (Oct 2018) VAAR 852.233-71 Alternate Protest Procedures (Jul 2002) FAR 52.233-2 Service of Protest (Sep 2006) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: Hand-Carried Address: RPO West, Network Contracting Office 19 (NCO 19 Rocky Mountain Acquisition Center Department of Veterans Affairs 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Mailing Address: RPO West, Network Contracting Office 19 (NCO 19) Rocky Mountain Acquisition Center Department of Veterans Affairs 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of Provision) FAR 52.212-3, Offeror Representations and Certifications - Commercial Items (Oct 2018), the offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (r) of this provision. In addition, complete the following addendum to FAR 52.212-3: The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018), applies to this acquisition. Addendum to FAR 52.212-4 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (MAY 2019) FAR 52.203-99 Prohibition on Contracting with Entities That Require Certain Internal Confidentiality Agreements (Deviation) (Feb 2015) FAR 52.216-19 ORDER LIMITATIONS (OCT 1995) (a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $10,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. (b) Maximum order. The Contractor is not obligated to honor (1) Any order for a single item in excess of $920,000.00; (2) Any order for a combination of items in excess of $920,00.00; or (3) A series of orders from the same ordering office within 14 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section. (c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section. (d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 14 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source. (End of Clause) FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. (End of Clause) 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 52.222-54, Employment Eligibility Verification (Oct 2015) FAR 52.224-1, Privacy Act Notification (Apr 1984) FAR 52.224-2, Privacy Act (Apr 1984) FAR 52.228-5, Insurance Work on a Government Installation (Jan 1997) 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 (May 2018) VAAR 852.215-71, Evaluation Factor Commitments (Dec 2009) VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (Jul 2016) (Deviation) VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2018) VAAR 852.237-7, Indemnification and Medical Liability Insurance (Jan 2008) VAAR 852.237-70, Contactor Responsibilities (Apr 1984) VAAR 852.271-70, Nondiscrimination in Services Provided to Beneficiaries (Jan 2008) All quotations shall be sent via email to christy.lee@va.gov. This is an open-market combined synopsis/solicitation for services as defined herein. The Government contemplates award of a Firm-Fixed-Price, Blanket Purchase Agreement resulting from 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:" Quoters shall list exception(s) and rationale for the exception(s). Submission shall be received not later than September 16, 2019 at 2:00 PM MST - christy.lee@va.gov. All submission shall be 5MB or less. If the email is going to be more than 5MB, then please submit in multiple emails labeling 1 of XX, 2 of XX, etc. 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 Contracting Officer, Bai Perney, bai.perney@va.gov and Contract Specialist, Christy Lee, Christy.lee@va.gov by July 26, 2010 at 12:00 PM MST. Contracting Office Point of Contact: Bai Perney, Contracting Officer, bai.perney@va.gov, 303-712-5815 Christy Lee, Contract Specialist, chirsty.lee@va.gov, 303-712-5731 NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (27-AUG-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/36C25919Q0521/listing.html)
- Place of Performance
- Zip Code: 84148
- Record
- SN05420406-F 20190829/190827230050 (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
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