Drug of Abuse Laboratory Testing Services for VA VISN1 New England Medical Centers
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Department of Veterans Affairs
Veterans Health Administration (VHA)
Sources Sought Notice Obtain Toxicology Drug laboratory testing services to be performed off-site on behalf of the VA VISN1 New England Medical Centers
This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of your company s offered services and capabilities. The Government will not pay any costs for responses submitted in response to this Source Sought Notice.
This Sources Sought notice provides an opportunity for respondents to submit their capability and availability to provide the service requirements described below. Vendors are being invited to submit information relative to their potential to fulfill this requirement, in the form of a capability response that addresses the specific requirement identified in this Sources Sought.
The Veterans Health Administration (VHA) is seeking to obtain toxicology drug laboratory testing services to be performed for the VA VISN1 Medical Centers located in New England. The services shall be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section as described below. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). Refer to the General Requirements section below for the requested service description. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy.
General Requirements:
Services are required to perform off-site urine/serum drug confirmation laboratory testing services and associated transportation services for the Department of Veterans Affairs Medical Centers, (hereinafter referred to as VAMC s). The contract shall cover urine/serum drug confirmation laboratory testing services and oral fluid drug screens for the specific Cost Per Test (CPTs) identified in the Test Menu Attachment. The services shall be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section of the PWS. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).
Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, specimen transport, tools, materials, supervision, and other items and services necessary to perform urine/serum drug confirmation testing services and oral fluid drug screens as defined in the PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.
Objectives:
Urine/Serum Drug laboratory confirmation testing with sample volume requirement 10 milliliters (mls) or less
Oral Fluid Screens
Mandatory Turnaround Time (TAT): Provide results within 48 hours or less of receipt of specimen at contractor laboratory.
This is crucial and if an offeror cannot comply with this turnaround time, your offer will not be accepted. If you are an offeror that states you can comply with this turnaround time and then when the test is ordered, it does not turnaround in this timeframe, this will be considered a breach in contract and the contract may be immediately terminated.
Transportation of Specimens Provide overnight delivery services. Specimens shall be tracked from pick up through delivery via an electronic tracking system.
CPT codes 8000-9000 shall be included as well as generic codes (G codes) when new tests are implemented. New tests or products not identified in the contract may be added with the permission of the Contracting Officer (CO) and Contracting Officer s Representative (COR). Pricing will be reviewed and determined to be fair and reasonable prior to ordering products or services.
Locations:
The following VA Medical Centers plan on utilizing these services:
VA West Roxbury 1400 VFW Parkway, West Roxbury, MA 02132;
VA Boston, 150 South Huntington Ave, Boston, MA 02130;
VA Brockton, 940 Belmont Street, Brockton, MA 02401;
VA Bedford, 200 Springs Road, Bedford, MA 01730;
VA Connecticut, West Haven Campus, 950 Campbell Ave, West Haven, CT 06516;
VA Newington (consolidated with West Haven) 555 Willard Ave, Newington, CT 06111;
VA Providence, 830 Chalkstone Ave, Providence, RI 02908;
VA Togus, 1 VA Center, Augusta, ME 04330;
VA Manchester, 718 Smyth Road, Manchester, NH 03104;
VA Northampton, 421 North Main Street, Leeds, MA 01060;
VA White River Junction, 215 North Main Street, White River Junction, VT 05009
*NOTE: This list may be amended at any period during subject contract to include other Veterans Affairs Medical Centers in the New England region.
General Information:
The Contracting Laboratory shall:
Provide the necessary personnel, transportation, materials, supplies, and equipment, to perform and report accurate and timely urine drug of abuse confirmation tests. This agreement will support the VISN 1 Network Consolidated Laboratory System (NCL).
Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations concerning drug testing, alcohol testing and program management.
Provide urine/serum drug confirmation testing services and oral fluid drug screens and transportation services as outlined in the objectives section of this document. Shall perform testing entirely upon their premises.
Have adequate controls and quality assurance processes in place to ensure the ordered testing is performed and reported on the right patient. Note, repeated errors of this nature may be considered a breach in contract and grounds for termination of the contract.
Provide results within a TAT of 48 hours or less from specimen receipt at contractor laboratory.
Provide individual patient-chartable test result reports meeting CLIA requirements and shall be electronically transmitted to each point of contact (POC) for local printing or faxed to each POC. Printed reports shall include:
The name and address of the contract laboratory where each test was performed
The specimen accession number of the contract laboratory
The name of the contract Laboratory Director or Medical Director
A phone number to contact the contract laboratory concerning the test results
The patient s name.
The patient s SSN.
The patient s age or date of birth.
The patient s sex.
The Medical Center/CBOC specimen identification number.
The specimen collection date.
The Contractor s report date and time.
The test name.
The test result(s).
The unit of measurement for quantitative tests.
Assay cutoffs for quantitative tests.
The report status (i.e., final or interim).
Other interpretive information appropriate for the test(s).
The ordering provider name
Specimen source
Conditions of the specimen that may limit adequacy of testing
Store specimens for at least fourteen (14) days after the reporting of the results.
Accept the VA electronically generated manifest as the laboratory order requisition. Single requisitions shall not be required. One printed manifest will be provided with each shipment of multiple samples.
Accept the facility NPI number and not require individual provider NPI numbers
Not require a diagnosis or patient specific demographics (insurance number, address, phone number). This contract requires institutional invoicing.
Accept verbal add-on orders only from site designated laboratory staff. VA POC Staff contact information will be provided upon award.
In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor shall, without additional charge, provide express overnight shipping or courier delivery of printed reports to each POC until the automated information system is properly functioning.
Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.
The contractor laboratory shall not release patient s records that include test results, without the specific written consent to release such information as provided by the patient, to any person, other than the ordering healthcare provider or designee. All member 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 do not use Protected Health Information received from any VISN1 site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).
Provide a Laboratory Manual containing the following information:
Department hours of operation
Accreditation
Technical Staff
Service Departments( Method of contacting, phone numbers, hours of availability)
Quality Assurance Information Billing Procedures & fee schedules for services provided
Procedures and criteria for phoning reports and other important information
Sample Report forms
Assay cutoffs
Drug detection times
Provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving at all times including weekends and holidays. *NOTE: Also include names and telephone number(s) of technical Directors and Pathologists available for consultation weekends and holidays.
Agree to maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification shall be given to VA upon adverse action by a regulatory agency.
Assign a specific local account representative.
Advise facility of any changes in methodology, procedure or reference ranges at least two weeks in advance of the change.
Contractor shall have the ability to obtain a VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) within 90 days after receipt of award and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor s host computer system and the Government s host computer system (VistA). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.) This shall be ready for implementation within 90 days of receipt of BPG ISA and MOU. Contractor shall provide, install, and if necessary remove, all required telecommunication equipment, hardware, software, and related consumable supplies to support the transmission of electronic data to all site VAMC s included in this contract. This may include, but is not limited to:
Generic Instrument Manager (GIM) for the interface connection
Shipping list printers
Software licenses
Lantronix boxes
Interface drivers
Bar-code printers
Back-up result printers connected directly to Contractor s computer system
Any required communication lines
Software to receive and send orders, display status of and/or test results
Consumable supplies to maintain the operation of the equipment listed above, e.g. toner, etc.
Contractor shall be responsible for all annual recurring costs associated with support and maintenance of the interface system including all equipment, software and instrument connections. The Contractor shall coordinate with the respective Government Information Technology Department.
The Contractor shall conduct preventive maintenance, as needed, and repair of Contractor furnished hardware, software and associated communication lines. In addition, throughout the performance period of the contract, the Contractor shall repair or replace any contractor provided malfunctioning hardware or software at no additional cost to the Government.
Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain and support the services of the host-to-host linkage between the Government and the Contractor.
Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training shall ensure that Government staff is capable of performing routine servicing of hardware. The Contractor shall certify in writing successful test validation of the interface.
Licensing and accreditation Contracting Laboratory:
Shall have all licenses, permits, accreditation and certificates required by Federal law and State law in the states of MA, ME, RI, CT, NH, and VT.
Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided with the Contractor s proposal and updated as needed to the Contracting Officer to include the Contractor laboratory s Laboratory Director and/or Medical Director.
Medical Director shall have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards.
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.
Shall comply with the regulatory requirements of Centers for Medicare & Medicaid Services.
Shall notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.
Contract Performance Monitoring
Quality Control (QC): The contractor shall operate a successful QC program, as required by CLIA and CAP. The QC program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s QC program is the means by which the contracting laboratory assures that work complies with the requirements of the contract. A QC program shall be submitted as part of an offer and put into place upon final contract award. After acceptance of the QC plan, the contractor shall receive the contracting officer s acceptance in writing of any proposed change to this QC system.
Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission and regulations as required for performing the type of services described herein. The government shall evaluate the contractor s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on the evaluation methodology to determine if 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).
Federal Holidays: (The contractor does not have to perform on these holidays except as described in this PWS.)
New Year s Day Labor Day
Martin Luther King Jr. s Birthday Columbus Day
President s Day Veteran s Day
Memorial Day Thanksgiving Day
Independence Day Christmas Day
Hours of Operation: The contractor is responsible for meeting the 2 day mandatory turnaround time from receipt of specimens. Business hours for the contractor are set at their discretion. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within the PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications shall be kept current with any change of personnel assigned to this contract. The contractor shall be available for telephone consultation and to respond to technical and administrative issues during the hours Monday Friday 8:00 am to 6:00 pm EST including holidays.
Physical Security:
The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contracting laboratory. Any specimen that is lost by the contracting laboratory shall incur a charge of $100.00 and will be credited to the Government on the monthly invoice.
Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend a post award conference convened by the contracting activity in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the contracting officer will apprise the Contractor of how the Government views the contractor's performance and the contractor will apprise the Government of problems experienced, if any. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.
Key Personnel: The following personnel are considered key personnel by the government:
List will be provided upon final Government award.
The Contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30 p.m. EST/EDT, Monday thru Friday, except Federal holidays or when the Government facility is closed for administrative reasons.
Identification of Contractor Employees:
All contract personnel attending meetings or working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They shall also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.
Continuing Education:
Contractor shall provide at least one educational session annually, either online educational sessions (webinar, webcast etc.) or in person at a central location designated by the Program Director of the VISN1 NCL at a mutually agreeable date/time. These educational sessions shall include educational/scientific updates related to Laboratory Medicine or other appropriate topics and shall be customized to meet the needs of the VA Pathology and Laboratory Medicine Service and Clinical Staff. Presentations shall be provided to the NCL Program Office at least two days prior to session commencement. No proprietary or promotional materials shall be included in the educational presentations.
Test Menu - Cost Per Test (CPT) Attachment
NOTE: Quantities are estimated, based on historical usage and not guaranteed
Test
Estimated Annual Qty
6 Acetylmorphine - Heroine Metabolite
1488
Amphetamines, quantitative confirmation, urine
550
Barbiturates, quantitative confirmation, urine
44
Bath Salts Panel, quantitative confirmation, urine
980
Benzodiazepines, quantitative confirmation, urine
1106
Buprenorphine with Naloxone
16
Buprenorphine, quantitative confirmation, urine
408
Cannabinoids, quantitative confirmation, urine
418
Carfentanyl -Designer Fentanyl
100
Cocaine, quantitative confirmation, urine
244
Dextromethorphan, quantitative confirmation, urine
24
EtG (Ethyl Gluc), quantitative confirmation, urine
2472
Ethyl Glucuronide by EIA scrn reflex
500
Fentanyl, quantitative confirmation, urine
500
Gabapentin, qualitative confirmation, urine
4476
MDMA Confirm
550
Meperidine Confirmation
200
Methadone and metabolite, quantitative confirmation, urine
126
Methamphetamine D/L Isomer
252
Nicotine & metabolite, urine
260
Opiate, quantitative expanded confirmation, urine
1488
Oral Fluid Saliva Screen, quantitative confirmation, saliva
254
Oxycodone and metabolite, quantitative confirmation, urine
1396
PCP, quantitative confirmation, urine
20
Propoxyphene metabolite, quantitative confirmation, urine
14
Ritalinic Acid, quantitative confirmation, urine
1424
Synthetic Cannibinoids scrn reflex to confirmation
1280
Tapentadol, quantitative confirmation, urine
4
Tramadol, quantitative confirmation, urine
4306
RESPONSE COMMITMENT
I. NOTES:
A. All questions, comments or concerns shall be directed to Valerie.DeAngelis@va.gov
B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility to participate in a future acquisition does not depend upon a response to this notice.
C. Proprietary information is neither requested nor desired. If such information is
submitted, it must clearly be marked "proprietary" on every sheet containing such
information, and the proprietary information must be segregated to the maximum extent
practicable from other portions of the response (e.g., use an attachment or exhibit).
II. TIMELINE:
A. This request will close 5 business days after this notice is published on the FBO site.
III. Requested information:
Interested parties shall provide the following information in addition to your capability response:
A. Format:
1. MS Word or pdf format (please ensure email is under 5 mb)
2. Page limit 2-4 pages (please make the response as brief and concise as possible)
3. Company name and Sources Sought number listed on each page
B. Specifics:
1. In your response, please provide the following information based on the
requirement.
a. Your company s capability of fulfilling this requirement as it is described.
2. Please also provide name of company, company address, a contact person s
name, telephone number, fax number and email address.
3. DUNS number, and indicate if actively registered on System for Award
Management (SAM)
4. Contractual vehicles the company holds, such as NAC or GSA schedules.
5. Socio-economic Status & NAICS Code: State the size of your company [e.g.,
8(a) (including graduation date), HUBZone-certified small business, Service-
Disabled Veteran-Owned small business, small business, large business, etc.].
Notes:
1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or otherwise, that a procurement action will follow. The Department of Veterans Affairs will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, The Department of Veterans Affairs reserves the right to contact any respondent to this notice for the sole purpose of enhancing The Department of Veteran Affairs understanding of the notice submission.
2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for content marked or designated as business confidential or proprietary which will be fully protected from release outside the government.
The Department of Veteran Affairs Contracting Office Point of Contact:
Valerie DeAngelis
Contracting Officer
Email: Valerie.DeAngelis@va.gov
Valerie DeAngelis
Contracting Specialist
401-459-4760 x1594
valerie.deangelis@va.gov
