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Pharmacogenetic Testing Services - Attachment

General Information

Document Type:FILE
Posted Date:Oct 31, 2017
Category: Medical Services
Set Aside:N/A

Contracting Office Address

Department of Veterans Affairs;Overton Brooks VA Medical Center (90C);510 East Stoner Avenue;Shreveport LA 71101

Description

Disclaimer The Department of Veterans Affairs is conducting market research to assess industry capabilities and identify competitive sources able provide preventive maintenance inspections, and emergency repair services for VA owned high-tech medical equipment and software identified in the table below. All equipment is housed at the Overton Brooks VA Medical Center located at 510 E. Stoner Ave., Shreveport, LA. All information received in response to this notice marked proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any information submitted by and obtained in response to this notice may be used in development of the final work statement, cost estimates or terms and conditions of the actual solicitation. The anticipated NAICS code is 621511 Medical Laboratories. The Government anticipates a set-aside requirement; however, the socio-economic classification has not been determined at this time. Submit responses to the Contracting Officer by noon (CT) Monday November 6, 2017. Subject Line: 36C25618Q0107 -Pharmacogenetic Testing Source Sought Response Background: Overton Brooks VA Medical Center requires the capacity to order pharmacogenetic testing on Veterans who are on polypharmacy or who present with medication resistance or medication sensitivity. These tests will assess for the presence of genetic variants responsible for adverse drug reactions. A recent study completed a retrospective analysis of patients with known metabolic liver enzyme genotypes. They found 1053 potential major or substantial interactions in 501 of 1143 (~44%) individuals. Of these, 66% were drug-drug interactions, 15% were drug-gene interactions, and 19% were drug-drug-gene interactions. This is important because these interactions are closely linked to adverse drug reactions. According to the FDA and Center for Disease Control and Prevention, adverse drug reactions are a major preventable public health problem that cost billions of dollars and affect millions of individuals every year. It is estimated that adverse drug reactions are responsible for approximately 100,000 deaths yearly and are the fourth to sixth leading cause of death in the USA. (Source: CDC, FDA, Verbeurgt et. al., Pharmacogenomics (2014) 15(5), 655 665). Objective: The Government is seeking qualified responsible sources able to provide a turn key mail based service for Pharmacogenetic Testing services; pricing shall be all inclusive. The contractor shall be required to minimally provide the following Contractor will supply test kits. Test Kits that include cheek swabs, specimen envelopes, consent forms, requisition forms and return mailing envelopes Turn-key mail-in process to achieve desired outcome Process for VA providers to rapidly and efficiently obtain test results Quality control process to ensure test results are not corrupted Chain of custody oversight to ensure PII is not compromised Key personnel to maintain operational oversight Qualified staff to perform testing services Specific Testing Requirements: CYP2C9 / VKORC1 - liver metabolism CYP2C19 - liver metabolism CYP2D6 - liver metabolism CYP3A4 / CYP3A5- liver metabolism CYP1A2 - liver metabolism CYP2B6 - liver metabolism COMT - catecholamines, dopamine 5HTT - serotonin transporter HTR2A - serotonin 2A HTR2C - serotonin 2C MTHFR - methylfolate GRIK4 - glutamate receptor ADRA2A - alpha 2A adrenoreceptors HLA-A or HLA-B - carbamazepine rxn Specific Questions to Industry: Can your company provide the service? If so, please submit a capabilities statement. Please provide a brief overview of the mailing service. Does your company offer these services on GSA, NAC or any other IDIQ contract? If so, what is the contract number? What is the average turn-around time and your process for receiving test results back? How are test results returned to the facility (mail, web portal, courier)? Does your company have a national BAA in place with the VA? If so, is it listed on the BAA website? Can you provide proof that your staff is fully trained and competent to provide this service? What is the socio-economic status of your company? Provide a description of your quality control process. Does your company provide the service at other VA facilities or commercial hospitals? If so, please provide contract & contact information. What are the projected unit costs for each individual test identified above?. Does the price per test include the mail in service, or is there a separate fee for the mail-in service? Based on the stated objectives, what are the recommended best practices? Is there a separate cost for the test kits? Do you have a sample PWS you can share? Do you have a sample QASP you can Share? Do you have sample or recommended evaluation criteria you can share?

Original Point of Contact

POC Fredrick L Wilson

Place of Performance

Address:
Overton Brooks VA Medical Center;510 E. Stoner Ave.;Shreveport, LA
71101,
Link: FBO.gov Permalink
Link: FBO.gov Permalink
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