The Veteran s Administration (VA) Office of Research and Development, Service Area Office East in Pittsburgh, PA intends to negotiate on a sole source basis with Lynn Oaks Compounding Pharmacy of Thousand Oaks, CA. The requirement is for the vendor to provide compounding pharmacy services. The services will include compounding, packaging and delivery of hypnotic medication for a VA funded medical research study (The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans (IIR 16-244)). The services/supplies required are: The contractor shall perform the initial quality assurance tasks and obtain the calibration/packing statistics for each dose of medication that will be compounded. The contractor shall obtain and maintain copies of certificate of analysis for each medication. The grade must meet or exceed requirements of the United States Pharmacopeia (USP). For each prescription written for a research subject, the contractor shall provide the specific medications and doses and compound the specified doses into capsules. The capsules shall be packaged in multiple 7-day blister packs according to the research protocol. Each blister pack will be labeled with the week of the protocol (e.g., Week A, Week B, etc.) and patient name. The package type shall comply with any applicable 21 CFR regulations, CDER guidance, and compendial monographs. Each blister shall be labelled according to the specified protocol (e.g., Day 1, Day 2, Day 3, etc.). The contractor shall deliver the blister packs to the VA West Los Angeles Healthcare Center research pharmacy using an overnight mail delivery or courier service within 5 days of receiving the prescription. The contractor shall prepare and deliver additional blister packs within 12 hours of receiving a prescription for subjects who have a change in their taper schedule or if any problems (e.g., wrong medication) are encountered. Deliverables Base Year The contractor shall compound, package and deliver prescriptions for an estimated 14 patients to the VA West Los Angeles Healthcare Center Research Pharmacy. Option Year 1 The contractor shall compound, package and deliver prescriptions for an estimated 24 patients to the VA West Los Angeles Healthcare Center Research Pharmacy. Option Year 2 The contractor shall compound, package and deliver prescriptions for an estimated 25 patients to the VA West Los Angeles Healthcare Center Research Pharmacy. Option Year 3 The contractor shall compound, package and deliver prescriptions for an estimated 3 patients to the VA West Los Angeles Healthcare Center Research Pharmacy. The only medications and doses that will be compounded and dispensed as part of this contract are listed in the table below. Compounded Dose (mg) Original dose .125 .25 0.5 1.0 1.25 1.87 2.5 3.75 5.0 7.5 10 15 30 Zolpidem 10 mg P P P Zolpidem 5 mg P P P Temazepam 30 mg P P P Temazepam 15 mg P P P Temazepam 7.5 mg P P P Lorazepam 1 mg P P P Lorazepam 0.5 mg P P P Alprazolam 1 mg P P P Alprazolam 0.5 mg P P P Clonazepam 0.5 mg P P P Estimate Graph Example: Base Period Option 1 Option 2 Option 3 Hypnotics Costs/ subject # subjects Total costs # subjects Total costs # subjects Total costs # subjects Total costs Zolpidem 8 14 15 3 Temazepam 1 3 2 0 Lorazepam 3 3 3 0 Alprazolam 2 3 3 0 Clonazepam 0 1 2 0 Set-up costs Costs/year Qualification and Licensing Requirements The contractor must be located within 50 miles (or within 60-minutes) from VA West Los Angeles Healthcare Center (11301 Wilshire Blvd, Los Angeles CA 90073). The contractor shall have a current Drug Enforcement Administration (DEA) license, controlled substance license, and license from the California State Board of Pharmacy. Before compounding medications for this research study, the contractor shall obtain a non-sterile compounding accreditation by the Accreditation Commission for Health Care (ACHC). Pharmacists compounding and dispensing these medications shall be licensed in California and in good standing with the California State Board of Pharmacy. Privacy Requirements The contracted pharmacy that is authorized to fill prescriptions under this contract must agree to the following conditions: The fax machine that receives prescriptions containing patient information shall be located in a secure location and not accessible to unauthorized individuals. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires that names of patients, and any information concerning patients, are considered privileged information and shall not be disclosed or revealed in any way for use outside the VA. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such information as the VA. Patient confidentiality will be adhered to at all times. As Contractor personnel will have access to patient information during their performance of duties under this contract, Contractor shall make its personnel aware that any such information that they might become aware of during the course of their performance is considered privileged information and shall not be disclosed or revealed in any way outside communications with Dr. Fung and her staff. Pharmaceutical services provided to VA beneficiaries shall meet all standards set forth in the current version of The Joint Commission accreditation manual for Ambulatory Care/Pharmaceutical Services. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Tuesday, Sept 11, 2018, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at
[email protected]. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.