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This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products and/or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.
The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.
The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this Sources Sought Notice in accordance with (IAW) FAR Part 15.201(e).
The purpose of this Sources Sought Notice announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the products and/or services described below.
Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following:
(a) Company Name;
(b) Address;
(c) Point of Contact;
(d) Phone, Fax, and Email;
(e) UEI Number;
(f) Cage Code;
(g) Tax ID Number;
(h) Type of Small Business, e.g., Services Disabled Veteran Owned Small Business, Veteran Owned Small business, 8(a), HUBZone, Women Owned Small Business, Small Disadvantaged Business, or Small Business HUBZone business, etc.;
(i) State if your business has an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed below and provide the contract number; and
(j) Must provide a capability statement that addresses the organization s qualifications and ability to perform as a contractor for the work described below.
Requirement:
The VA Heartland Network 15 Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide ALPHA-1-ANTITRYPSIN BUCCAL SWAB TESTING SERVICES for the Kansas City VA Medical Center, located in Kansas City, Missouri. This is a brand name or equal requirement. Please see the Statement of Work for more specifics and details.
The North American Industry Classification System Code (NAICS Code) is 541380 (Testing Laboratories), size standard $19.0. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a Small Business, VOSB or SDVOSB.
Important Information:
The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open may be used.
Responses to this notice shall be submitted via email to Lisa Buchanan at lisa.buchanan1@va.gov. Telephone responses will not be accepted. Responses must be received no later than Wednesday, May 8, 2024, at 8:00AM CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this source sought. Responses to this source sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.


STATEMENT OF WORK
INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish a Blanket Purchase Agreement (BPA) for Alpha-1 antitrypsin Buccal Swab Testing Services. Alpha-1-antitypsin Buccal Swab Testing Services include but are not limited to specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services The Government will award a BPA to a single Contractor for Alpha-1 antitrypsin Buccal Swab Testing Services. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide comprehensive genomic profile services to the Kansas City VA Medical Center and it s respective CBOCs. Contractor agrees to the following terms of the agreement exclusively with the VISN facilities listed by Attachment A and awarded in the final agreement. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor.
BACKGROUND
Alpha-1 antitrypsin (AAT) is a protein that has both anti-inflammatory and anti-proteolytic functions and serves to limit protease-induced injury to lung matrix proteins. A deficiency of AAT predisposes patients to chronic obstructive pulmonary disease (COPD) as well as other disorders including bronchiectasis and liver disease. Early identification of patients with alpha-1 antitrypsin deficiency (AATD) allows for interventions that can slow the effects of this disease, and improves morbidity, loss of lung function and mortality. The AAT buccal swab test is minimally invasive, allowing for collection in clinic as soon as at-risk patients are identified, therefore increasing detection of the disease.

SCOPE OF PROCUREMENT:
1. The Government will award to a single contractor for Alpha-1-antitrypsin Buccal Swab Testing Services.
2. Alpha-1-antitrypsin Buccal Swab Testing Services include but are not limited to specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services.
3. VISN 15 intends to establish the base year of the agreement starting 11/1/2024, with contract completion on 10/31/2029.
4. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide comprehensive genomic profile services to the Kansas City VA Medical Center and it s respective CBOCs.
5. Contractor agrees to the following terms of the agreement exclusively with the VISN facilities listed by Attachment A and awarded in the final agreement. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor.

GENERAL QUALIFICATIONS

Alpha-1-anti-trypsin Testing
1. The contractor shall provide testing using multiplex Polymerase Chain Reaction (PCR) methodology that identify less frequent rare alpha1 antitrypsin (AAT) deficient alleles.
2. The PCR allele-probes specific must provide detection of allelic variants to include Z, S, F, I mutations and rare alleles associated with AAT deficiency. The test must have the ability to identify 14 allelic variants of the SERPINA gene and identify the most frequently associated AAT deficiency.
a) The contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Alpha-1-anti-trypsin Buccal Swab Testing Services to Kansas City VA Medical Center, Kansas City MO.
3. Alpha-1-anti-trypsin Buccal Swab Testing Services include but are not limited to specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services.
4. Orders will be initiated when ordered by a physician. Each test will be patient specific; the need is Veteran specific.
5. The Contractor shall provide electronic access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital
Information System (HIS) or current Government Laboratory Information System (LIS). This information, at a minimum, shall include the following data elements:
a) Ordering Code (Contractor's Identification Code)
b) LOINC - Logical Observation Identifier Names and Codes
c) Test methodology
d) Test Description, including reference ranges (when appropriate, age and sex adjusted) and units of measurement
e) Specimen collection and handling requirements
f) Test result interpretation or interpretive remarks, if appropriate
6. All testing shall be performed on the Contractor s premises, or within the Contractor's network of laboratories. Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America.

Licensing, Accreditation and Certifications
1. Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.
2. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to BPA award. Changes to the requirements shall be addressed by bilateral modification.
3. Contractor Personnel assigned by the Contractor to perform the services covered by this BPA shall be eligible to provide the services of this BPA 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 BPA shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this BPA shall be licensed by the governing or cognizant licensing board.
4. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).
5. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the BPA within 24 hours of notification of an investigation or suspension.
6. Contractor Personnel: The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration.
7. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

CONTRACTOR S RESPONSIBILITIES:

Specimen Preparation and Storage or specimens
1. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. The testing methodology and reference ranges for a test must be defined in the Contractor s laboratory reference test manual.
2. The Contractor shall ensure that all tests performed meet the currently acceptable standard deviation and that have daily controls conducted to determine testing accuracy. Upon request by the Contracting Officer (CO) or assigned Contracting Officer s Representative (COR) for the applicable facility and the Contractor shall make available quality assurance information on specific testing procedures for review.
3. Supplies: The Contractor shall provide all materials and necessary supplies to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials and supplies include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. Testing materials and supplies include:
a) Requisition forms
b) Special instructions
c) Specimen transport containers and shipping forms, to include refrigerated packaging (if applicable).
d) Special media or tubes for samples
4. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.
5. The Contractor shall contact the assigned COR for the applicable facility within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies. The Contractor shall provide a mechanism for specimen pickup. The Contractor shall provide to the ordering facility the supplies and equipment within two (2) workdays after receipt of order. The assigned COR or assigned representative for each facility will request replenishment of supplies from the Contractor on an as needed basis.

Transportation Services for Samples:
1. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory. These supplies shall include, but may not be limited to:
a) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory.
b) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.
c) Test request forms preprinted with the appropriate Shipping Section details and account information.
d) Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).
e) The specimen will be returned to ordering facility, free of charge.

Specimen Testing
1. The Contractor shall provide the full range of clinical diagnostic testing capabilities to execute all required Alpa-1-anti-trypsin testing services as annotated in Attachment A. Contractor shall make available the following test information:
a) Requisition form requirements
b) Test order code
c) Specimen collection and preservation requirements
d) Test method employed (indicate if testing performed in duplicate) and interpretations
e) Test reference intervals adjusted for age, sex or race, when required
f) Test specific sensitivity, specificity and interferences, when required
g) Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a Government facility.
h) Schedule of test performance (specific days of week indicated)
i) Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab).
2. Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.
3. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.
4. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials.

Reporting of Results
1. A report of laboratory testing results must be issued either as a printed final copy or through the host-to-host electronic transmission of the test results. The Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e., MS Outlook, etc. is prohibited.
2. Each test report shall, at minimum, include the following information:
a) Patient's full name
b) Patient s identification number, e.g., social security number (SSN)
c) Physician s name (if supplied)
d) Government laboratory accession number (if supplied)
e) Submitting facility name
f) Submitting facility account number
g) Patient's location (clinic/ward) (if supplied)
h) Test(s) ordered
i) Date/time of specimen collection (when available)
j) Date/time test completed
k) Test result
l) Reference laboratory accession number
m) Name and address of testing laboratory
n) Any other information the laboratory has that may indicate a questionable validity of test results.
o) Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.
3. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.
Customer Service

1. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day; 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this BPA.
2. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the BPA performance period:
a) Telephone Inquiries Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government s minimum time expectation for meeting this service.

Specimen Collection
1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.
2. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within
3. ½ hour of the initial call.

Testing
1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.
2. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.
3. Technical Expertise
4. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.
5. Result interpretation inquiries shall be addressed within four business hours of initial call.
6. Consultative services where information is required regarding the
clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

Account follow-up

1. Information general in nature yet specific to the account, e.g., test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.
2. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.
3. The Government will place orders for specimen collection and transportation supplies and materials by telephone or through written or electronic methods.

Consultative Services
1. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

SPECIAL CONTRACTOR REQUIREMENTS

Services
1. Contractor is required to maintain medical liability insurance for the duration of this BPA. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during BPA performance.
2. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the BPA.
3. Contractor shall not, under any circumstances, furnish reports directly to patients
Qualifications/Requirements of Laboratory & Contractor Personnel

1. Laboratory
a) Offeror must have at least three years of experience in providing laboratory testing services and must have at least one-year experience in transporting biomedical materials.
b) Offerors, including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract.
c) Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the
Contracting Officer s Representative assigned to each Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.
d) Contractor must notify immediately the Contracting Officer s Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure.
e) Contractor shall 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.

2. Designation of Contract Representatives
a) The Regional Laboratory Manager VISN 15 Pathology & Laboratory Medicine Services (PLMS), Kansas City, MO, will be designated as the Lead Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The appointed COR will provide technical guidance, verify services were actually performed, and also verify that documentation for services performed is received prior to certifying payment.

3. Contract Performance Monitoring
a) Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:
i. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.
ii. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be
sufficient to ensure proper payment and allow audit verification that services were provided.
4. Quality Assurance Monitoring
a) Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract. The Government shall verify that services being performed by the Contractor are acceptable and in accordance with established standards and requirements of this contract.
b) Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program must minimally address the quality aspects representative to the testing process, i.e., pre-analytical, analytical, and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for
responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the
facility/VISN 15 staff for process review and improvement of contract performance on an as needed basis.
c) Copies of licensure/certifications are also required to be submitted upon request
d) Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc.
The Authorization requirements do not apply, and that a Security Accreditation Package is not required
5. Quality Assurance/Quality Control
a) The Contractor facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government at any time during the term of the contract.
b) The Contractor shall comply with all applicable OSHA, Federal laws, State laws, the Joint Commission, and regulations as required for performing the type of services required.
c) The Contractor shall comply with the following Quality Assurance guidelines relating to shipping and test performance:
i. Number of modified test results, not due to incorrect requisition information from the referring lab: d) In all cases, surveillance shall not be so intrusive as to impact the Contractor s successful accomplishment of the mission.
e) When unacceptable performance occurs, the assigned COR for the applicable facility shall inform the Contractor and contracting officer. This notification shall normally be in writing unless circumstances necessitate verbal communication.
In any case, the assigned COR for the applicable facility shall document the discussion and provide a copy of the document to the Contractor and Contracting Officer. When the assigned COR for the applicable facility determines formal written communication is required, the assigned COR for the applicable facility shall prepare a Contract Discrepancy Report (CDR) and present it to the Contractor's program manager and the Contracting Officer. The Contractor shall acknowledge receipt of the CDR in writing. The CDR shall specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR shall also state how long after receipt the Contractor must present this corrective action plan to the assigned COR for the applicable facility. The assigned COR for the applicable facility and Contracting Officer shall review the Contractor's corrective action plan to determine acceptability. All CDRs may become a part of the supporting documentation for any action deemed necessary by the Contracting Officer.

f) Quality assurance monitoring documentation shall become an official Government record of the Contractor s performance.

6. Transportation
a) Specimen Shipment
i. Sample Preparation: Each ordering activity shall prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user s manual. The Contractor shall provide at no charge an adequate supply of requisition forms, specimen collection materials, cooling packs, and special instructions. These requirements shall be defined in the laboratory user manual. The Contractor shall supply any special preservatives required for specimen preservation. Each ordering activity is responsible for packaging the specimens.
b) Shipping Biological and Infectious Substances:
i. Regulatory Requirements. The regulations governing the packaging and shipment of biological, infectious, and hazardous substances are primarily found in 49 CFR parts 100-185 and 397. The parts of 49 CFR specifically dealing with biological and infectious specimens are 107, 171, 172, and
173. While the majority of shipments packaged and processed by the clinical laboratories are classified as diagnostic specimens, all specimens, as well as any select agents and toxins that are identified, must be packed and shipped in accordance with the applicable guidance provided in 49 CFR. Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the Centers for Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the Department of Veterans Affairs.
7. Release of Medical Information:
a) The Contractor shall release medical information obtained during the course of this contract to authorized VISN staff.

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