Q301--LAB Test Growth
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E22Q0042 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2022-07. This requirement will be made using a cascading set-aside under the associated NAICS code 541380 with a small business size standard of $16.5 Million. The intended contract will be a four (4) year Indefinite Quantity/Indefinite Delivery contract with Firm-fixed price task orders. Attachments are included with applicable Provisions and Clauses, System and Information Security requirements, and a price breakdown. This document is the full solicitation document and along with the attachments include: a list of contract line items, a Description of requirements for the items to be acquired, SOW, Date(s) and place(s) of delivery, and applicable clauses and provisions. Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of best value to the government in accordance with the specifications and instructions outlined in FAR 52.212-1 and FAR 52.212-2 with addendums. A. General Information Title of Project: Lab Growth Hormone Assistance Serviced. Scope of Work: The contractor shall provide laboratory testing support for planned VA medical studies. The contractor shall be tasked will supporting a wide range of laboratory tests outlined below. Place of Performance: The work will be remote at the contractor s location. Travel is not expected for this contract however any required travel outside of contractor s local area will be reimbursed as appropriately with prior clearance. Ordering Period: The intended ordering period on the Indefinite Delivery/Indefinite Quantity contract is four (4) years from date of award. Actual performance periods will be outlined on each funded task order. Type of Contract: An Indefinite Delivery/Indefinite Quantity contract with Firm-Fixed Price task orders. B. Background CSP 2018 Growth Hormone Replacement Therapy in Veterans with mild Traumatic Brain Injury and Adult Growth Hormone Deficiency (the GRIT Study) is a research study sponsored by the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP). The purpose of this multi-center clinical trial is to evaluate the efficacy and safety of growth hormone therapy in patients with head injuries and growth hormone deficiency. CSP 2018 is double-blind, placebo-controlled trial where the patient nor the local site research team will know who is receiving the study drug or placebo; Only the study s Centralized Endocrinologist will have regular access to the treatment assignment. Patients will be randomized at a 1:1 ratio into one of the two groups: active growth hormone replacement therapy or placebo given daily for 6-months. The study s primary endpoint is Quality of Life, as measured by the Adult Growth Hormone Deficiency Assessment (AGHDA-QOL) questionnaire. The study s planned duration is 36 months: 30 months intake + 6 months follow-up; the study s requisite sample size is 172 participants. The primary objective of CSP 2018 is to determine the efficacy of growth hormone treatment versus placebo on quality of life (QoL) as measured by the mean difference in QoL scores. The secondary objective is to investigate the effects of growth hormone treatment on cardiometabolic risk factors including lipids and highly sensitive C-reactive protein (hs-CRP) after 6-months of treatment. Cardiometabolic risk factors are important to assess because elevated lipids and CRP are associated with poor health outcomes. The primary biomarker of interest in titrating study therapy is Insulin-like Growth Factor 1 (IGF-1). Potentially eligible Veterans will be measured for IGF-1 once during the screening process; randomized participants receiving study therapy will be measured for IGF-1 ##5## times during the study. IGF-1 is the particular biomarker that has both the greatest relevance to our study design, and the most intensive logistics in obtaining and routing results, is only known to be offered by few vendors, at limited locations, and the IGF-1 value have to be known only to the Centralized Endocrinologist post-randomization. IGF-1 values will be used to titrate the study therapy. IGF-1 processing is a mandatory requirement. Adult growth hormone deficiency (AGHD) is recognized as a complication in patients with moderate to severe traumatic brain injuries (TBI), yet Veterans with mild TBI are rarely evaluated or treated for AGHD. Specialized blood tests are required to diagnose AGHD, and the diagnostic process is expensive and time consuming. Growth hormone and IGF-1 measurements are widely used in the diagnosis and management of GH disorders. Therefore, it is imperative to obtain accurate and precise measurements of these hormones. Insulin growth factor-1 is a hormone secreted by the liver. Growth hormone regulates the secretion of IGF-1 by the liver, and the concentration of IGF-1 in the blood has been found to be directly proportional to the concentration of GH. Because of this relationship, IGF-1 will be used to titrate growth hormone replacement therapy and monitor GH levels toughout the study. There are multiple assays GH and IGF-1 assays currently available. The heterogeneity of analytes and the lack of uniformity in calibrator materials creates considerable differences between GH and IGF-1 results. The Growth Hormone Research Society, the International Society for IGF Research, and the Pituitary Society recognize the need to harmonize assay standards and have published GH and IGF-1 standardization guidelines. GH assays must meet the World Health Organization (WHO) 98/574 standard, and laboratories should use internal quality control materials independent of those provided by the assay manufacturer. The lab should also participate in accredited proficiency testing and external quality assessment program using materials that have been proved commutable at a national or international level. Two of the most critical blood tests for this study are the GH assay because it is used to establish diagnosis for inclusion in the study, and IGF-1 because it is used to diagnose and monitor GH toughout the clinical trial. Therefore, finding a contract laboratory who meets the rigorous standards set forth by the GH Research Society is a requirement for this contract. Given the many and varied biomarkers being collected in CSP#2018, and the potential complexity in coordinating processing and data integration from multiple facilities, study leadership prefers to contract all biomarker processing to a single vendor, ideally at a single processing site. A central laboratory is necessary to reduce variation across sites and to standardize the measurement over the four-year study: small differences in IGF measurement can significantly affect the interpretation of the study therapy, and thus the titration. The variations in biomarker assays at local labs is well-recognized and even small errors in calibration in some assays can have potentially major consequences for study integrity. Veterans will also undergo additional blood tests to rule out other hormonal disorders and/or medical conditions that are contraindicated in this trial. Among those labs is testosterone. Testosterone is an important measure because hormonal dysregulations must be addressed prior to enrollment in the trial, and administration of growth hormone may cause alterations of testosterone. Thus, monitoring testosterone before and toughout the trial is critical. Testosterone is present in the body in multiple forms: testosterone bound to sex-hormone binding globulin (SHBG) and albumin and the rest is unbound testosterone (also known as free testosterone). Total testosterone may be insufficient for diagnosis of mild abnormalities of testosterone homeostasis, so free testosterone must also be measured. Total testosterone shall be measured by liquid comatography-tandem mass spectrometry certified by an accuracy-based standardization or quality control program (e.g. Centers for Disease Control and Prevention, CDC, Hormone Standardization Program for Testosterone). Free testosterone shall be measured directly from equilibrium dialysis assays, or by calculations that utilize total testosterone, SHBG, and albumin concentrations. However, because this test is more specialized than the ordinary total testosterone count, not all laboratories perform this assay. In fact, many VA medical centers outsource testosterone to other labs. Table 1 in the next section provides a comprehensive list of all the blood tests for CSP 2018 and collection schedule. Although many of the other screening and safety labs required for the study are routine, the logistics of having each site submit samples to multiple labs is extremely cumbersome. Further, lab samples in a clinical trial should be processed by a single laboratory to ensure standardization of results and specimen processing techniques. C. Scope and Methodology Because of the cost of time involved in endocrine stimulation tests (e.g., Macrilen stimulation test to assess AGHD and ACTH stimulation test to assess adrenal insufficiency), the screening labs are broken up into two visits. At the first screen visit, Veterans will undergo basic routine labs such as complete blood count (CBC), complete metabolic panel (CMP), and Hemoglobin A1c. Cardiometabolic risk factors (lipids, in particular low-density lipoprotein, LDL, and hs-CRP) will also be collected at screen visit. Because cardiometabolic factors are stable for at least a month, collecting them at screen visit will satisfy the baseline measure of the trial. At this initial screening visit, patients will also undergo preliminary endocrine testing visit where basal hormone labs will be collected. Patients whose lab results from the initial screening visit meet inclusion exclusion criteria will undergo a growth hormone stimulation test (macimorelin) and, if needed, a cortisol stimulation test (Screening Visit #2). Those who are diagnosed with AGHD and meet all other inclusion criteria will be randomized into the 6-month treatment trial. Table 1 (below) depicts the blood test schedule for CSP 2018. Table 1. Laboratory Assessments Pre-Randomization Treatment Trial Screening Visit #1 Screening Visit #2 Visit Visit Visit Visit Visit Visit Anchor: Treatment S1 S2 D1 D15 D40 D65 D90 D180 Anchor: Screening Day 1 Day 15 (+/- 7 days) Day 30 (+/- 14 days) Day 45 Day 70 Day 95 Day 120 Day 210 LH X FSH X Estradiol X Prolactin X ACTH X HbA1c X X X X X X X Lipids X X X X X X X hsCRP X X X X X X X CBC X X X X X X X CMP X X X X X X X Testosterone (free, total) X X X X X X X FT 4 X X X X X X X TSH X X X X X X X IGF-1 (and SDS) X X X X X X Cortisol AM X X X X X X X ACTH Stimulation Test: Cortisol at 0, 30, and 60 minutes (3 assays) X Macrilen Stimulation Test for GH: GH 0, 30, 60, 90 min (4 assays) X CSP 2018 plans to randomize 9 patients per site over the course of four years (equivalent to 3 patients randomized each year per site). To randomize 3 patients a year, it is estimated that 11 patients will be screened annually, per site (44 Veterans screened at each site over the course of four years). Tables 2 and 3 show the projected number of patients per site and for the entire project, respectively. Table 2. Estimated Annual and Cumulative Enrollment, Per Site Number of Patients (Per Site) Year 1 Year 2 Year 3 Year 4 Total Screened 14 15 15 0 44 Randomized 4 4 4 0 12 Table 3. Estimated Annual and Cumulative Enrollment for Entire Clinical Trial Number of Patients (Entire Project) 4 Year Total Per Site # of Sites Total Screened 44 20 880 Randomized 12 20 240 To calculate the quantity of each test, the labs collected at screen visit are multiplied by the annual number of expected participants, per site. Labs Collected Monthly Estimate (per site) Yearly Estimate (per site) Total Study Estimate (per site) Monthly Estimate (all sites) Yearly Estimate (all sites) Total Study Estimate (all sites) LH1 1 11 41 18 205 820 FSH1 1 11 41 18 205 820 Estradiol1 1 2 5 3 25 100 Prolactin1 1 11 41 18 205 820 ACTH1 1 11 41 18 205 820 Cortisol 0, 30, 60*2 1 11 41 18 205 820 GH, 4 timepoints*2 1 11 41 18 205 820 HbA1c3 2 24 93 39 463 1,852 Lipids3 2 24 93 39 463 1,852 hs-CRP3 2 24 93 39 463 1,852 CBC3 2 24 93 39 463 1,852 CMP3 2 24 93 39 463 1,852 Testosterone3 2 22 88 37 439 1,753 FT43 2 24 93 39 463 1,852 TSH3 2 24 93 39 463 1,852 IGF-13 2 21 81 34 403 1,612 Cortisol AM**3 2 24 93 39 463 1,852 1Done Only at Screening Visit 1; 2Done Only at Screening Visit 2; 3Done at Screening Visit 1 and Post-Randomization Visits ** Cortisol AM is different than Cortisol 0, 30, 60. Lab Test Abbreviations: LH = Luteinizing Hormone FSH = Follicle Stimulating Hormone ACTH = Adrenocorticotropic Hormone GH = Growth Hormone HbA1c = Hemoglobin A1c LDL = Low Density Lipoprotein hs-CRP = High sensitivity C-reactive protein CBC = Complete Blood Count CMP = Complete Metabolic Panel FT4 = Free Thyroxine TSH = Thyroid Stimulating Hormone IGF-1 = Insulin Growth Factor I In addition to the screen labs, the following labs will be ordered for patients randomized into the treatment trial. Quantity is calculated by multiplying the number of visits the test will be collected (during treatment phase) x number of patients, per site. D. Description of Tasks, Associated Deliverables The contracted lab must satisfy the following criteria: The growth hormone (GH) assay shall be a validated immunochemiluminometric assay standardized to World Health Organization (WHO) recombinant GH calibration standard WHO 98/574. The GH assay shall be compliant with the recommendations on assay standardization set forth by the Growth Hormone Research Society. The IGF-1 assay shall be a validated immunochemiluminometric assay standardized to WHO IS 02/254 reference standard. Shall report standard deviation score (SDS) for IGF-1. Shall be able to provide references on how they derive the standard deviation score for IGF-1. Shall offer total- and free testosterone. Shall offer a validated cortisol assay measured by LC-MS/MS or by an immunoassay that has been correlated to LC-MS/MS so the cutpoint value for an ACTH stimulation test can be established. Total testosterone shall be measured by liquid comatography-tandem mass spectrometry certified by an accuracy-based standardization or quality control program (e.g. Centers for Disease Control and Prevention, CDC, Hormone Standardization Program for Testosterone). Free testosterone shall be measured directly from equilibrium dialysis assays, or by calculations that utilize total testosterone, SHBG, and albumin concentrations. Specimen shipped to processing facility, utilizing study identifiers in lieu of Personal Identifiers Single account number on all (vendor provided) requisition forms Vendor shall provide blood tubes appropriate for collection that possess unique barcodes, which can be used to create a crosswalk at the site between the tube and any PHI Vendor personnel and laboratory shall be compliant with all applicable laws and regulations Lab must be Clinical Laboratory Improvement Amendment (CLIA) approved E. Reporting Requirements The contracting laboratory shall make the test results available to the research team within 5-10 business days from submission date. Result reporting functionalities such batch reporting, exporting results as CSV file, direct input into iDataFax is preferred but not mandatory. The web portal shall be able to export the data; just showing the data without the ability to download is not acceptable. The CSPCC requests a representative sample of results for the purposes of developing the data management platform. Minimum report data must include: Specimen ID, date received, date tested, result/value (in units designated in this SOW). Calibration, frequency, and validation of instruments shall be submitted in the vendor s quality control plan. Study Leadership shall be informed in the event that usual and customary procedures change due to any circumstance or unforeseen event, to include lab closures. F. Reporting Requirements The contracting laboratory must make the test results available to the research team within 8 business days from date of receipt at Contractor. Result Access (view): Results must be made available tough 2 methods: 1) Web-based portal (with results views limited by site, i.e. one site cannot view the lab results of another site, while CSP coordinating center staff may access results from ALL sites) 2) SQL Server/Database/File Share (results from all sites, accessible by CSP coordinating center only) A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A Result Retrieval (view/download) All results shall be available to view via web browser (with the results view limited as described above) with the option to interactively download results file in .csv format A A A A A A A A A A A A A A A A All results must be available for download by CSP coordinating center staff in normalized database table or .csv file format via batch processing The CSPCC requests a representative sample of results for the purposes of developing the data management platform. Minimum report data must include: Specimen ID, date received, date tested, result/value (in units designated in this SOW). Calibration, frequency, and validation of instruments shall be submitted in the vendor s quality control plan. Study Leadership shall be informed in the event that usual and customary procedures change due to any circumstance or unforeseen event, to include lab closures. G. Other Considerations While Study Leadership expects that sample volume should be relatively constant toughout the study, Vendor shall be flexible with sample flow due to shifting recruitment patterns. A method to deliver laboratory test results in bulk on regular intervals shall be provided to the West Haven CSPCC.A Bulk is defined as multiple patient/participant test results in one file.A Regular delivery intervals may be as minimal as monthly to as great as daily.A It is preferred that the data delivery method provides the ability to automate the process tough a scripted, batch process.A Acceptable delivery methods for bulk test results may include but are not limited to: vendor provided web-based interface which permits batch retrieval of bulk test results, vendor or VA provided cloud storage and transfer platform (), batch file transfer to a VA system via sftp. The bulk test results shall be provided in a format that can be ingested by a secondary system. Acceptable formats for bulk test results include but are not limited to: normalized database (SQL preferred), delimited file (.csv, pipe). H. Kickoff Meeting A technical kickoff meeting shall be held within 10 days after award. The Contractor shall coordinate the date, time, and location (will be virtual) with the Contracting Officer (CO), as the Post-Award Conference Chairperson, the VA PM, as the Co-Chairperson,, and the COR. The Contractor shall provide a draft agenda to the CO and VA PM at least five (5) calendar days prior to the meeting. Upon Government approval of a final agenda, the Contractor shall distribute to all meeting attendees. During the kickoff-meeting, the Contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and project schedule for each effort via a Microsoft Office PowerPoint presentation. At the conclusion of the meeting, the Contractor shall update the presentation with a final slide entitled Summary Report, which shall include notes on any major issues, agreements, or disagreements discussed during the kickoff meeting and the following statement As the Post-Award Conference Chairperson, I have reviewed the entirety of this presentation and assert that it is an accurate representation and summary of the discussions held during the Technical Kickoff Meeting for the Accelerate Provider Directory effort. The Contractor shall submit the final updated presentation to the CO for review and signature within tee (3) calendar days after the meeting. The Contractor shall also work with the CS, the Government s designated note taker, to prepare and distribute the meeting minutes of the kickoff meeting to the CO, PM, COR, and all attendees within tee (3) calendar days after the meeting. The Contractor shall obtain concurrence from the CS on the content of the meeting minutes prior to distribution of the document. I. Changes to SOW Any changes to this SOW will be authorized and approved only tough written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Cost incurred by the contractor tough the actions of parties other than the CO will be borne by the contractor. All responses shall include information which demonstrates equivalency (as a minimum) to the specifications outlined in the solicitation. J. Delivery Delivery FOB Destination to: Michael E. DeBakey VA Medical Cener Baylor College of Medicine (BCM 350) One Baylor Plaza Houston, TX 77030 The applicable provisions and clauses are located on attached solicitation document. Additional contract requirement(s) or terms and conditions determined by the contracting officer: Set Aside Cascading set-aside procedures. Any award resulting from this solicitation will be made using a cascading set-aside order of precedence as follows: 1. In accordance with FAR Subpart 19.1405 and VAAR Subpart 819.7005, any award under this solicitation will be made on a competitive basis first to an eligible Service Disabled Veteran Owned small business [SDVOSB] concern provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 2. If there is inadequate competition for award to an SDVOSB concern, the SDVOSB set-aside shall be withdrawn and cascaded to the next contracting order of priority in accordance with VAAR 819.7004, which is Veteran Owned Small Businesses (VOSB) and conducted in accordance with the procedures set forth in VAAR 819.7006 provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 3. If there continues to be inadequate competition between SDVOSB and VOSB concerns, the cascading will continue tough the contracting order of priority in accordance with VAAR 819.7004 and FAR 19.203. If the contracting officer determines that offers from small business concerns do not meet the solicitation requirements in terms of technical acceptability, past performance, and fair market price, the small business set-aside[s] will be withdrawn and award will be made on the basis of full and open competition. Adequate competition: Adequate competition shall be deemed to exist if At least two competitive offers are received from qualified, responsible business concerns at the set-aside tier under consideration; and Award could be made at fair market price as determined in accordance with FAR 19.202-6. The VA contracting officer reserves the right to consider competitive proposals submitted from all responsible offerors (including large businesses) in determining the fair market price. Due date and submission of questions and quotes: The quotes are due on 3/13/2023 at 10:00 AM (EST) and shall be directed electronically to Michael.haydo@va.gov. Quotes shall be marked with the solicitation number. Information regarding the solicitation can be addressed to the Contracting Officer, Michael Haydo at email: michael.haydo@va.gov The final date for questions will be 3/3/2023 at 10:00 AM (EST). All responses to questions will be posted as an amendment to the solicitation for all potential offerors to view. Attachments: 1. Applicable Provisions and Clauses 2. System and Information Security Requirements 3. Price List Breakdown
36C24E23Q0042 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
2/24/23, 8:49 AM