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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 23, 2017 FBO #5721
DOCUMENT

Q -- VISN Wide Germline Genomic Testing Multiple Award BPA - Attachment

Notice Date

7/21/2017
 

Notice Type

Attachment
 

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

VA25917N0858
 

Response Due

8/4/2017
 

Archive Date

8/19/2017
 

Point of Contact

Sura-Quay Arbon
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCE SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. The Department of Veterans Affairs Network Contracting Office (NCO) 19, Greenwood Village, CO is performing market research to locate possible Small Business, Veteran Owned Small Business (VOSB) and/or Service Disabled Veteran Owned Small Business (SDVOSB) contractors able to specialized, off-site referral laboratory germline genetic testing, for Veterans Integrated Service Network (VISN) 19 Medical Centers, these centers are located in the following states: Oklahoma, Utah, Wyoming, Montana, and Colorado. The Government will use responses from this notice to make the appropriate acquisition decisions, specifically in regards to multiple award BPA s. All interested firms who can meet the requirements stated below should respond, in writing (via email), with information describing their interest, capabilities, geographic location and indicate which socio-economic business category for which they qualify to the Contract Specialist Sura-Quay M. Arbon, Sura-Quay.Arbon@va.gov, no later than 5:00 p.m. (Mountain Time), August 4, 2017. All SDVOSB/VOSB respondents must be VETBIZ certified, registration shall be verified at https://www.vip.vetbiz.gov/. DISCLAIMER This RFI/Sources Sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI/Sources Sought that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI/Sources Sought. All requirement listings below are in draft form and subject to change. General Requirements: 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 requirments 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) 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. 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 VHMC 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 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 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. 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. The government shall evaluate the contractor s performance under the contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). 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. 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. THIS IS A SOURCE SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25917N0858/listing.html)
 

Document(s)

Attachment
 

File Name: VA259-17-N-0858 VA259-17-N-0858_FBO.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3677998&FileName=VA259-17-N-0858-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3677998&FileName=VA259-17-N-0858-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04590181-W 20170723/170721235122-20f036963539f5ff0dd59f88895cb902 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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