Clinical Pharmacology Quality Assurance (CPQA) Program
Introduction:
This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are: small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
Background:
The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions.
The purpose of NIAID Clinical Pharmacology Quality Assurance (CPQA) Program is to provide a comprehensive quality assessment program for clinical pharmacologic laboratories testing samples from subjects enrolled in NIAID-supported clinical studies. The CPQA Program ensures the validity and inter- and intra-laboratory comparability of pharmacological study data by providing laboratories with materials for pharmacology proficiency testing and assay controls, and monitoring proficiency and assay data from each laboratory. The program also develops and implements standards of performance for new pharmacology assays, develops and tests methods relating to the assays, and acquires, tests, stores, and dispenses quality control materials and reagents. Thus, the CPQA Program is critical to the scientific integrity of on-going and future studies concerning the assessment of therapeutic and prevention measures for HIV and other infectious diseases.
The current contract provides services to 11 U.S. and non-U.S. clinical pharmacology laboratories (Labs) affiliated with NIAID-supported clinical trial networks and collaborating study groups (User Groups). Labs are chosen by User Groups to participate in a clinical trial. It is critical to evaluate, both initially and on an on-going basis, the ability of Labs to perform protocol-specified pharmacology assays correctly and reliably.
The current contract is held by the Research Foundation for the State University of New York (SUNY) on behalf of University of Buffalo, under Contract No. HHSN272201500006C. The period of performance of the current contract is May 30, 2015 through May 29, 2022.
Purpose and Objectives:
The purpose and of the proposed contract will be to continue to provide a Clinical Pharmacology Quality Assurance Program resource to provide comprehensive quality assessment programs to clinical pharmacology laboratories (Labs) that test samples from subjects enrolled in NIAID-supported clinical studies. The Contractor shall: (1) monitor and evaluate the ability of Labs to accurately and reliably perform study-specified pharmacology assays through an International Organization for Standardization (ISO)-certified proficiency testing program; (2) support the development, validation and implementation of pharmacology assays; (3) acquire, characterize, store, and distribute to Labs, quality control materials and reagents; (4) provide guidance, assistance, and training to laboratory and clinical site staff, in proficiency testing, assay validation, and in the conduct of clinical pharmacology studies; (5) prepare Labs for FDA and other regulatory inspections and study audits; (6) maintain data management systems for tracking and managing CPQA activities; (7) publish and disseminate results, to improve the quality of pharmacology measurements made in NIAID supported clinical trials; and (8) provide for initial and final transition of the contract. Options to provide increased level of effort to support additional labs (domestic and international) and to support unanticipated increases in demand for the activities supported by the base requirements of the contract, are also within the scope of the contract.
Anticipated Period of Performance:
It is anticipated that a cost reimbursement, term/level of effort type contact will be awarded. The period of performance will be for one year (Base Period) plus six (6) one-year options to extend the term of the contract, that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately February 28, 2022. The requirement will be the delivery of 8.85 full time equivalents (FTEs) per year for the Base Period (Year 1) and 8.85 FTEs per year for Options 1-6 (Years 2-7). The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
In addition, the Government may exercise options for an increased level of effort that may result from the need to support additional labs (domestic and international) and to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Options for increased services may include the following:
1. Options 1 through 6, to Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the Base Period (Year 1), annually, for a total contract period of up to 7 years. The scope and types of activities, as outlined for Year 1 of the contract, would be continued for each succeeding annual contract period, up to 7 total years. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
2. Options 7 through 12, to Increase the Level of Effort for Additional Domestic Labs: During the course of the contract, it may be necessary to incorporate additional US-based pharmacology laboratories. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option, which may be exercised unilaterally. Each Option of this type will implement work commensurate with the addition of one (1) domestic Lab. Up to one Option per year may be exercised during Years 2 through 7 of contract performance. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.60 Full Time Equivalent (FTE) per option. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
3. Options 13 through 18, to Increase the Level of Effort for Additional International Labs: During the course of the contract, it may be necessary to incorporate additional international pharmacology laboratories. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option, which may be exercised unilaterally. Each Option of this type will implement work commensurate with the addition of one (1) international Lab. Up to one Option per year may be exercised during Years 2 through 7 of contract performance. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.60 FTE per option. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
4. Increased Level of Effort for Unanticipated Increases in Demand (Options 19-32): The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option, which may be exercised unilaterally. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE for each option exercised. These options may be exercised twice per year, during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base year or Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
Other important considerations:
The Respondent will be expected to host and maintain the existing computerized data management system and enhance it when necessary.
In addition, the Contractor will be expected to ship AGRS/reference drug powder, PT and QC samples (i.e., QCMs), and reagents to specified U.S. and non-U.S. Labs, under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with International Air Transport Association (IATA) (https://www.iata.org/en/publications/dgr/) and International Civil Aviation Organization (ICAO) (https://www.icao.int/safety/DangerousGoods/Pages/default.aspx) dangerous goods shipping regulations, and other relevant shipping regulations.
Capability Statement/Information Sought:
Capability statements submitted as a result of this announcement should demonstrate the Offeror’s qualifications, expertise, and experience, specifically providing evidence as to the capability to perform this requirement, with particular attention to the following:
1. Monitoring performance of laboratories ability to accurately and reliably perform pharmacology assays (e.g., HPLC-MS, UPLC-MS, HPLC-UV) through an ISO-accredited program (ISO 17043). This shall include design of proficiency testing (PT) programs; preparation of PT panels that include drug analytes being tested in NIAID-supported clinical trials, varying concentrations of each drug in relevant biomatrices that span the expected therapeutic range of the drug, and human biomatrices without drugs to support the specificity of the PT sample within each laboratory assay method; receipt and statistical analysis of test results; assessment of lab’s testing performance; generation of Lab-specific performance reports; and provision of remediation samples to Labs for re-testing, when performance failure is identified.
2. Supporting and facilitating pharmacology assay development, validation, and implementation conducted by the Labs. This shall include development assays for a variety of biomatrices (including novel and non-traditional matrices), new drugs and drug metabolites; instructing Labs in the construction of Assay Validation Reports (AVRs), including the subsequent review and evaluation of AVRs to ensure the accuracy, sensitivity, specificity, and precision or reproducibility of the methods; develop and refine AVR Standard Operating Procedures (SOPs), Quality Assurance (QA) documents, and guidance documents for assay implementation; and development of procedures that refine sampling process, sample processing and storage.
3. Acquiring (in compliance with FDA requirements and ISO standards), characterizing, storing, documenting, and distributing [under appropriate shipping conditions and in accordance with International Air Transport Association (IATA) and International Civil Aviation Organization (ICAO) dangerous goods shipping regulations, and other relevant shipping regulations] Quality Control Materials (QCMs) to specified U.S. and non-U.S. Labs, which include analytical grade reference standards (AGRS)/reference drug powder, and other reagents needed for the preparation of quality control materials (QCMs) for pharmacology proficiency testing and for assay development, validation, and implementation.
4. Providing guidance, assistance, and training to Labs, to perform pharmacological assays reliably, validate assays correctly, and to effectively communicate with clinical sites regarding guidance for the appropriate acquisition and processing of subject samples for pharmacological testing. Assisting and guiding Lab staff in corrective action(s), when testing proficiency is not acceptable; assisting and guiding Labs in procedures and SOPs for performing pharmacology assays and conducting clinical pharmacology studies; providing guidance, via an on-line tutorial, to clinical site staff, on concepts of pharmacokinetics (PK) and pharmacodynamics (PD), and guidance for the appropriate collection and processing of samples obtained from subjects participating in clinical trials; and providing assistance and guidance to clinical investigators and technicians at NIAID-funded investigator meetings, in order to improve testing proficiency, optimize assay development, and achieve appropriate patient sample handling.
5. Preparing laboratories for FDA (or other regulatory agencies) laboratory inspections and study audits, via conducting on-site lab inspections and study-specific audits that assess lab’s overall quality of operations, quality planning and quality improvement (pre-analytical, analytical, and post-analytical); and reporting the findings and deviations, and interacting closely with the Lab, in order to assist the Labs in preparing remedial action plans, to be completed by the Lab (and reviewed by the Contractor) prior to an audit by a regulatory agency. The Contractor shall maintain the capability to perform on site and/or remote assessments.
6. Hosting and maintaining the existing CPQA computerized data management system and document library to track and make available documents in support of activities performed under the contract. The Contractor shall utilize the existing CPQA computerized data management system, and further enhance the system, as necessary. The Contractor must have the ability to maintain the computerized system security documentation, as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA). This shall include a comprehensive assessment of the management, operational, and technical security controls in the system, to determine the extent to which the controls are implemented correctly, operating as intended, and producing the desired outcome with respect to meeting a specified set of security requirements for the system. The NIAID Information System Security Officer (ISSO), or his designee, shall assess the documentation provided by the Contractor, in order to support the NIAID Chief Information Officer’s (CIO’s) decision on whether to authorize the operation of the federal system and grant an Authority to Operate for said system.
7. Disseminating CPQA technical and scientific data.
8. Administrative and Technical Support, which includes: participating in a Contract Initiation meeting with NIAID staff; participating in annual site visits with NIAID staff; planning, conducting, and participating in teleconferences with NIAID staff to review overall progress; and planning, conducting, and participating in teleconferences with key Contractor personnel and specific Lab investigators to review Lab-specific problems, resolutions, and progress towards achieving reliable performance.
9. Audits: NIAID may authorize, at any time during the contract period of performance, independent audits (including for-cause audits) of Contractor performance with respect to the functions specified in the Statement of Work, including review of Contractor processes, procedures, and operations at the Contractor’s site. For audits conducted at Contractor facilities, the Contractor shall ensure that appropriate staff and all necessary information and documentation are available.
10. Execute Initial and Final Transition: In the event of transition between contractors, the Contractor shall ensure an orderly, secure, and efficient transition of all contract activities, contract-related data, documents, and other materials, from the incumbent contractor or from the Government (for a new Contractor transitioning in), or to a new Contractor or to the Government (for an incumbent Contractor transitioning out), as applicable, and as directed by the Contracting Officer. This includes the provision of an Initial and Final Transition Plan, as applicable, and as directed by the Contracting Officer.
Personnel/Management: The prospective contractor must have a Principal Investigator and key staff with training, experience, expertise, and qualifications, with respect to Clinical Laboratory Improvement Amendments (CLIA), current Good Laboratory Practices (cGLP), Good Clinical Laboratory Practice (GCLP), assay development and validation, statistical methods and computerized systems, creating and utilizing training tools, customer service and laboratory trouble shooting, and performance of all aspects of the Statement of Work. In addition, the Contractor will be expected to have the necessary experience and expertise to carry out a project of this size and complexity, must understand technical and regulatory issues relevant to resource-constrained countries, and must have the flexibility to address emerging needs and expansion. Additionally, interested parties must indicate availability of key professional and technical staff for the proposed project.
Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity.
Capability statements submitted as a result of this announcement should demonstrate the Offeror’s qualifications, expertise, and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the Respondent’s capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.
Required Business Information:
Capability statements submitted as a result of this announcement shall also include the following information:
• DUNS;
• Company Name;
• Company Address;
• Company Point of Contact, Phone, and Email address;
• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought;
• Do you have a Government approved accounting system? If so, please identify the agency that approved the system; and
• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://beta.sam.gov/. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).
NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract, including that performed by any subcontractors and consultants. The Contractor shall ensure that any and all processes meet international, federal, local, and state regulations, in order to ensure the continuity and validity of the resulting product.
Page Limitations:
Interested qualified small business organizations should submit a tailored Capability Statement, not to exceed five (5) pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5” x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such.
Number of Copies:
Please submit one (1) electric copy of your response as follows:
All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Shane Sarchiapone, Contract Specialist, at shane.sarchiapone@nih.gov, in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS75N93021R00003. Facsimile responses will not be accepted.
Common Cut-off Date:
Electronically submitted tailored capability statements are due no later than 2:00 p.m., EST, NOVEMBER 16, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.
Disclaimer and Important Notes:
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the Contract Opportunities section of beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality:
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
SBSS-75N93021R00003 Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases
10/30/20, 11:04 AM