Q– Obtain FISH and other laboratory testing services
Notice Type: Sources Sought Notice
Posted Date:
Office Address:
Subject: Q-- Obtain FISH and other laboratory testing services
Classification Code:
Solicitation Number: 36C24118Q0081
Contact: Valerie DeAngelisContracting Specialist 401-459-4760 x1594 mailto:[email protected]
Description:
Providence VAMC
Page 1 of 9Department
Sources Sought Notice Obtain laboratory testing services to perform Off-Site Fluorescence In Situ Hybridization (FISH) and other select laboratory testing services
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 requirement 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
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 Fluorescence in situ hybridization (FISH) and other select testing for the
Objectives:
Fluorescence in situ hybridization (FISH)
Oncology reference laboratory testing on peripheral blood, bone marrow and embedded paraffin tissue
Professional interpretation for select cases
Other select testing
Scope:
The contractor shall provide testing as outlined in the Performance Work Statement (see test menu attachment for identification of specific tests). For laboratory samples, the VAMC will provide either an electronic generated patient worklist or contractor provided requisition form containing at a minimum the patient s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider, sample type and date of birth (second identifier). For specialized testing, the VAMC will provide a brief clinical history only when necessary.
CPT codes 8000-9000 shall be included as well as generic 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
The following VA Medical Centers may also utilize these services during the life of this BPA:
VA
VA Providence,
VA
VA
VA Maine HCS, 1 VA Center,
General Information:
Perform testing services entirely upon their premises.
Accept
Accept the unique facility National Provider Identifier (NPI) number and not require an NPI for each individual ordering practitioner.
Perform analytical testing for VAMC patients for the tests defined in the test menu included in the PWS. The Contractor shall bill only for the tests specified in the request sent by the
Provide a reference test manual, and report of analytical test results and consultative services as required, assimilating the full scope of its laboratory operations.
Provide VAMC with appropriate laboratory supplies not customarily utilized by the VAMC. These supplies are to be used by the VAMC 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 all test result reports/consults in less than 7 days of receiving the sample. Reports shall be downloadable in pdf format.
Provide complete processed samples as defined in the test menu.
Return all embedded tissue within 5 days of completing sample processing and reporting.
Provide a consultation/professional interpretation when requested on select cases.
Results shall include all applicable information, not limited to:
Patient s full name
Patient s date of birth
Patient s full social security number or unique hospital identification number
Ordering Physician s name
Date/time of specimen collection, when available
Date/time test completed
Test(s) ordered
Test result(s)
Flagged abnormal results - if applicable
Type of specimen/source
Any additional comments related to test provided by ordering physician, if applicable
Unsatisfactory specimen shall be reported with regard to its unsuitability for testing
VAMC submitting facility name
Patient location- if supplied
Date/time specimen receipt
Abnormal intervals/Toxic & therapeutic ranges - if applicable
Any other information the laboratory has that may indicate a questionable validity of test results.
VAMC facility account number
Contractor accession number
Contractor address
Reference intervals- if applicable
Testing laboratory name
Consult with VAMC on test results by telephone, as needed.
Provide training, at no additional charge, for pathologist(s) to retrieve processed specimen data and create interpretation report on the contractors portal and lab staff to download completed reports.
Provide a printed or electronic Laboratory Manual containing the following information:
Testing methodology for a test must be defined in the laboratory user s manual
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
Report forms
Provide telephone number(s) and contact person(s) to be used by the VAMC to make specimen problem inquiries and problem solving on weekdays. *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 shall be given to
Assign a specific local account representative.
Advise VAMC facility of any planned changes in methodology, procedure or reference ranges at least 14 days prior to changes. In the event that two week notification is not possible due to emergency, contractor shall notify VAMC as soon as possible.
Not release patient s records that include test results to any person other than the ordering healthcare provider or VA Pathology and Laboratory Medicine staff member. 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 VAMC site that would constitute a violation of any applicable provision in standards set forth in HIPAA.
Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the sending
Licensing and accreditation
1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law.
2. Shall be accredited by the
3. Medical Director(s) shall have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards.
4. Personnel assigned 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
5. Shall comply with the regulatory requirements of Health and
6. Shall notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.
7. Shall maintain safety and health standards consistent with the requirements set forth by the
Contract Performance Monitoring:
Quality Control: The contractor must operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with the PWS. 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.
The VAMC will maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VAMC and may include, but is not limited to , unidentified split specimens sent periodically to the contractor for testing, split specimen 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 the VAMC during the life of the contract.
Quality Assurance: The Contractor shall comply with all applicable
Federal Holidays: (The contractor does not have to perform on these holidays)
Independence
Hours of Operation: The contractor is responsible for providing services
Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contractor laboratory. Each specimen that is lost by the contractor laboratory will incur a charge of
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 CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.
Contractor Program Manager: 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 CO. 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
Identification of Contractor Employees:
All contract personnel attending meetings, and 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 must 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 either online educational sessions (webinar, webcast etc.) or in person at a central location designated by the Program Director of the VISN1
Contractor Furnished Items and Responsibilities:
The Contractor shall furnish all supplies, equipment, facilities and services required to perform work as outlined in this contract.
RESPONSE COMMITMENT
I. NOTES:
A. All questions, comments or concerns shall be directed to [email protected]
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
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
information submitted in response to this notice at its discretion and will not provide comments to any
submission; however, The
this notice for the sole purpose of enhancing
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.
Contracting Officer
Email: [email protected]
Test Menu Attachment
NOTE: Quantities are estimated and not guaranteed
Description/Part Number*
Est. Qty.
Customized Panels
*-
FISH, B-CELL CLL PANEL 88374 technical (
60
FISH, B-CELL CLL PANEL 88374 professional (
1
FISH MYELOMA PANEL 88374 technical (
50
FISH MYELOMA PANEL 88374 professional (
10
FISH, HES/LEUKEMIA 88367 technical (PDGFRA Rearrangement)
2
FISH, HES/LEUKEMIA 88367 professional (PDGFRA Rearrangement)
2
FISH,PDGFRB,5q33.1 88367 technical (PDGFRB Rearrangement)
1
FISH,PDGFRB,5q33.1 88367 professional (PDGFRB Rearrangement)
1
FISH MDS PANEL 88374 technical (
80
FISH MDS PANEL 88374 professional (
10
FISH MYELOMA PANEL 88374 technical (
50
FISH MYELOMA PANEL 88374 professional (
10
CHROMOSOME FISH,D13S319 88367 technical (13q- (13q14, 13q34)
5
CHROMOSOME FISH,D13S319 88367 professional (13q- (13q14, 13q34)
1
FISH,MYELOMA,IGH PANEL 88374 technical (Mult. Myeloma IgH Complex Reflex FISH panel)
50
FISH,MYELOMA,IGH PANEL 88374 professional (Mult. Myeloma IgH Complex Reflex FISH panel)
5
FISH, AML M3,
2
FISH, AML M3,
2
*-
*-
Additional Tests
*-
Oncology Chromosome Analysis (Cytogenetics) 88264, 88291, 88237
70
ALL Adult 88374 technical
5
ALL Adult 88374 professional
5
AML Standard 88374 technical
5
AML Standard 88374 professional
5
AML Favorable Risk 88374 technical
3
AML Favorable Risk 88374 professional
3
AML Non-Favorable Risk 88374 technical
8
AML Non-Favorable Risk 88374 professional
4
Eosinophilia 88374 technical
4
Eosinophilia 88374 professional
4
High-Grade/Large B-Cell Lymphoma 88374 technical
3
High-Grade/Large B-Cell Lymphoma 88374 professional
3
Low-Grade/Small B-Cell Lymphoma 88374 technical
4
Low-Grade/Small B-Cell Lymphoma 88374 professional
4
MPN 88374 technical
4
MPN 88374 professional
4
NHL 88374 technical
7
NHL 88374 professional
7
X/Y for Engraftment 88374 technical
1
X/Y for Engraftment 88374 professional
1
6
6
Plasma Cell Myeloma Risk Stratification (IMWG/MRC) 88374 technical
5
Plasma Cell Myeloma Risk Stratification (IMWG/MRC) 88374 professional
5
B-Cell Gene Rearrangement 81261, 81264, MOLB
50
T-Cell Receptor Beta Gene Rearrangement 81340
50
T-Cell Receptor Gamma Gene Rearrangement 81342
15
BCR/ABL Translocation, t(9;22),
10
BCR/ABL Major Breakpoint 81206
10
BCR/ABL Minor Breakpoint 81207
10
BCR/ABL for CML 81206
10
BCR/ABL for ALL 81207
10
BCR/ABL, t(9;22) Major (p210) & Minor (p190) for CML 81479
10
BCR/ABL p230 81208
10
c-KIT Mutation Analysis (Bi-directional sequencing
5
NeoTYPE AML Favorable-Risk Profile
0
NeoTYPE AML Prognostic Profile
0
NeoTYPE CLL Prognostic Profile
0
NeoTYPE JMML Profile
0
NeoTYPE Lymphoma Profile
0
NeoTYPE MDS/CMML Profile
0
NeoTYPE MPN Profile
0
NeoTYPE Myeloid Disorders Profile
0
B-Cell Gene Rearrangement (Fragment Length Analysis)
0
B-CELL IGK Gene Analysis
0
B-Cell IGH Gene Rearrangement
0
Cytogenetics no growth
5
B-Cell Gene Rearrangement (B-cell Clonality) (FFPE) 81261
0
B-Cell Gene Rearrangement (B-cell Clonality) 81261
0
T-Cell Gene Rearrangement (Fragment Length Analysis) 81342
0
TRG Gene Rearrangement (T-Cell Clonality) (FFPE) 81479
0
TRG Gene Rearrangement (T-Cell Clonality) 81479
0
TRG Gene Rearrangement (T-Cell Clonality) Beta 81340
0
TRG Gene Rearrangement (T-Cell Clonality) Beta (FFPE) 81340
0
TRG Gene Rearrangement (T-Cell Clonality) Gamma (FFPE) 81342
0
TRG Gene Rearrangement (T-Cell Clonality) Gamma (FFPE) 81342
0
B&T-Cell Gene Rearrangement (Fragment Length Analysis)
0
B&T-CELL IGK Gene Analysis 81261
0
B&T-Cell IGH Gene Rearrangement 81264
0
B&T-Cell TRG Gene Rearrangement 81342
0
BCL-1 Translocation t(11:14) 81401
0
BCL-2 Translocation t(14;18) 81402
0
SF3B1 81479
5
Tissue Bone Culture 88237
120
Cytogenetics Interpretation and Report 88291
120
Cytogenetics Study without interpretations 88237 or 88233 or 88264 or 88280
1
Additional Tissue Culture Bone 88237
15
MYD88
5
Chromosome Analysis 88280
120
Link/URL: https://www.fbo.gov/spg/VA/PrVMAC650/PrVAMC650/36C24118Q0081/listing.html
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