Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JANUARY 08, 2023 SAM #7712
SOURCES SOUGHT

Q -- NEW - Oncotype DX Testing 671-23-2-121-0088

Notice Date

1/6/2023 11:46:10 AM
 

Notice Type

Sources Sought
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
 

ZIP Code

76006
 

Solicitation Number

36C25723Q0274
 

Response Due

1/13/2023 8:00:00 AM
 

Archive Date

02/12/2023
 

Point of Contact

Ognian Ivanov, Contract Specialist, Phone: ognian.ivanov@va.gov, Fax: 210-694-6302
 

E-Mail Address

ognian.ivanov@va.gov
(ognian.ivanov@va.gov)
 

Awardee

null
 

Description

Sources Sought Notice This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information ONLY. This is NOT a solicitation for proposals, bids, proposal abstracts, or quotations. The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women-owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 621511. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Commercial Business Opportunities website http://www.beta.sam.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. The STVHCS has a continued need for Oncotype Diagnostics testing for Breast, Prostate and Breast DCIS tissues. Oncotype DX tests help doctors predict the future activity of cancer by analyzing genes in samples of the breast and prostate. The test results can help determine the risk of metastasis, which is when cancer appears or returns to a distant part of the body. They can also help predict the potential benefits of chemotherapy or radiation therapy. The contractor must provide the following services: The contractor s laboratory must provide testing and can perform analysis for Oncotype Diagnosis-Breast, Oncotype Diagnosis-Prostate listed in Attachment A. These services require a CAP-certified, CLIA-accredited laboratory with the ability to perform a wide menu of genetic testing. Contractor(s) must provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to services as defined in the requirements except for those items specified as government furnished property and services. The contractor must 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. 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: 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 within the US. Analyze samples. Provide a monthly bill for tests completed each month following the month in which the service was delivered. Consultation service with VA Laboratory on test results by telephone as needed. Means of communication to permit immediate inquiry regarding the status of a pending test. 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. Provide a list of tests currently available with a price list. Perform analytical testing for STVHCS patients for the tests requested. The Contractor shall bill only for the tests specified in the request sent by STVHCS laboratory service. Provide a reference test manual and report of analytical test results, upon award, describing the full scope of its laboratory operations. Provide STVHCS with laboratory supplies (collection tubes, transport packaging, etc.) not customarily utilized by STVHCS. These supplies are to be used by STVHCS only 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 STVHCS 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 STVHCS on test results by telephone, as needed, during regular business hours. Provide telephone number(s) and contact person(s) to be used by STVHCS 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 STVHCS of any planned changes in methodology, codes, or new procedures at least 14 days prior to changes. If a two-week notification is not possible due to an emergency, contractor shall notify STVHCS as soon as possible. Do not release patient s records that include test results to anyone other than the ordering healthcare provider, to include STVHCS where the biospecimen collection originated and STVHCS 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 STVHCS 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 Test(s) ordered Date/time of specimen collection (when available) Date/time specimen received in Reference Lab Date test completed Type of specimen/source Test result(s) Flag abnormal results Name of testing laboratory (contractor and/or subcontractor), address, CLIA number Testing laboratory specimen number Type of specimen Comments related to the test provided by the submitting lab Information that may indicate a questionable validity of test results 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: 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 how the contractor laboratory assures that work complies with the requirement of the contract. STVHCS 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 STVHCS 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 STVHCS 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). 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 STVHCS 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. INVOICING: Payment to be made monthly in arrears by certified invoices and must contain the contract number and obligation number in addition to the requirements detailed in 52.212-4 (G) to be considered valid. Invoices shall also contain a line item for each test and quantities billed for. STVHCS will not pay for tests that are not clearly identified by accession number on the Contractors invoice. WORK HOURS: Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows: New Years Day, Martin Luther King s Birthday, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated as a national holiday by the President of the United States. contracting officer representative: The Contracting Officer Representative (COR) is identified as the Administrative Officer for Pathology and Laboratory Medicine Service. Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the Contracting Officer's Technical Representative (COR). All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. Period of Performance: Base + 4 Option Years Deliverables/Supplies: Reference Lab testing for Oncotype Diagnosis for: Breast, Colon, Prostate. Please advise if you can provide the deliverables for this requirement. Please submit all information to Ognian Ivanov mailto:ognian.ivanov@va.gov no later than Friday , January 13, 2022, 11:00 AM ET (10:00 AM CT).
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/755cd38bea334a3dbc41acec71e23f07/view)
 

Place of Performance

Address: Department of Veterans Affairs South Texas Veterans Healthcare System Pathology / Laboratory Medicine 113, San Antonio, TX 78229, USA

Zip Code: 78229

Country: USA
 

Record

SN06558657-F 20230108/230106230103 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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