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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 04, 2018 FBO #6006
DOCUMENT

Q -- PCAB Sterile and NonSterile Compound Products - Attachment

Notice Date

5/2/2018
 

Notice Type

Attachment
 

NAICS

446110 — Pharmacies and Drug Stores
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
 

ZIP Code

37129
 

Solicitation Number

36C24918Q9392
 

Response Due

5/9/2018
 

Archive Date

7/8/2018
 

Point of Contact

Scheronica Cochran
 

Small Business Set-Aside

N/A
 

Description

This is a Sources Sought Notice for the Tennessee Valley Healthcare System (TVHS), Nashville Campus to determine the availability of potential sources, relative to NAICS 541512 having the skills and capabilities necessary to provide PCAB sterile and nonsterile compounding services. This Request for Information (RFI) is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this RFI will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The contractor shall provide PCAB sterile and nonsterile compounding services at TVHS located at 1310 24th Avenue South, Nashville, TN 37212. This is not a solicitation but a request for information only to determine the availability of services and marketing pricing for the service requirement. The information provided may be used by the Department of Veterans Affairs, Network Contracting Office located in Murfreesboro, Tennessee as a requirement for PCAB sterile and nonsterile compounding services for Tennessee Valley Healthcare System, in developing its acquisition strategy and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information submitted in response to this RFI. Please send all written responses via email to Scheronica.Cochran@va.gov; no phone calls please. Note: Please review attached Scope of Work for detailed requirements. STATEMENT OF WORK FOR COMPOUNDED PRODUCT PREPARATION The contractor shall provide requested high-risk and/or specialized sterile and non-sterile compounded products on an as needed basis by the Department of Veterans Affairs Medical Center; hereinafter called VA, Tennessee Valley Healthcare System (TVHS). The contracted compounding pharmacy shall provide those products for which no commercial source of the product is available and pursuant to a valid VA TVHS patient-specific prescription. The preparation of all sterile products shall be in compliance with all United States Pharmacopoeia (USP) Chapter and Chapter standards and federal, state, and other regulatory requirements as described herein: A. DUTIES AND RESPONSIBILITES Specific Regulatory Compliance 1.The outsourcer shall be registered in good standing with the FDA as a 503A compounding pharmacy. 2.The outsourcer shall have accredited and be in good standing with Pharmacy Compounding Accreditation Board (PCAB) 3.The outsourcer shall have a state pharmacy license available where the compounding center resides. 4.If located outside the state of Tennessee, the outsourcer shall be licensed to ship to Tennessee. 5.If the outsourcer prepares a significant number of non patient-specific preparations (>5% of the outsourcer s volume, the outsourcer shall be registered as a 503B Outsourcing Pharmacy with the Food and Drug Administration (FDA). 6.The outsourcer shall be registered with the Drug Enforcement Administration (DEA) as required and appropriate. 7.All pharmacists working for the outsourcer shall be licensed in the state where they are practicing. 8.If required in the state where the compounding center resides, all pharmacy technicians shall be licensed or registered in the state where they are practicing. 9.The outsourcer meets or exceeds state required pharmacist-to-pharmacy technician ratios for the state in which the compounding center is located. 10.If an FDA-approved product is commercially available (not on backorder), the outsourcer shall never compound the same drug formulation using non-sterile powders or other components. 11.When no commercial source exists to prepare admixtures, the outsourcer shall use USP grade bulk ingredients obtained from a current Good Manufacturing Practice (cGMP) compliant supplier. The outsourcer shall additionally be able to provide a certificate of analysis and potency testing of all bulk ingredients used. 12.The outsourcer shall have the required minimum amount of product liability insurance as outlined by VA TVHS. 13.VA TVHS shall be covered by the outsourcer s product liability insurance in the event of any harm directly related to any product compounded by outsourcer s facility. 14.The outsourcer shall meet American Society of Health System Pharmacists (ASHP), National Institute for Occupational Safety and Health (NIOSH), and USP chapter and USP guidelines for handling hazardous agents. 15.The outsourcer shall be able to provide pedigree information that documents that they do not purchase products outside of traditional drug distribution networks or through secondary wholesalers. This shall include a Certificate of Analysis (COA). 16.The outsourcer shall comply with all rules and regulations inherent in the Drug Supply Chain Security Act (DSCSA). 17.If a commercial product component of a preparation is on backorder, the outsourcer shall be able to provide a certificate of analysis, potency testing, and proof that all other requirements are met (e.g., higher level clean room) for High Risk Level Compounding per USP. 18.The outsourcer shall immediately disclose any disciplinary or punitive action by any regulatory agency (e.g., FDA warning letter, state board of pharmacy). 19.The outsourcer shall immediately disclose any loss of PCAB Accreditation to the Contracting Officer and the TVHS Pharmacy Points of Contact. 20.The outsourcer shall be able to provide quality control history and quality assurance trend reports upon request. Quality and Patient Safety Measures 21.The outsourcer shall provide documentation that confirms staff competency (i.e., observation documentation on garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to and on an ongoing basis on the compounding of actual drug preparations. 22.The outsourcer shall provide documentation that confirms that the outsourcer tests aseptic techniques by preparing media fill tests per USP chapter standards. 23.The outsourcer shall provide documentation that confirms that pharmacists and pharmacy technicians are pre-qualified with 3 successful media fills BEFORE the compounding of actual drug preparations. 24.The outsourcer s staff shall be required to undergo re-qualification using media fill tests at a minimum of an annual basis if compounding medium risk agents or every 6 months if compounding high-risk agents. 25.At any time a positive media fill occurs, the outsourcer shall perform a comprehensive investigation to identify the root cause. The outsourcer shall then institute and document corrective and preventative action. Documentation of actions taken shall be provided to the VA upon request. 26.The outsourcer shall provide documentation of follow-up on all items requiring follow-up on their every 6 month hood and clean room recertification. 27.The outsourcer shall provide customers with substantial evidence that supports extended expiration dating for compounded sterile preparations when BUD limits in USP are exceeded. 28.The outsourcer shall perform studies to determine extended expiration dates, using evidence-based and validated stability and potency testing procedures, for compounded sterile preparations for which no extended expiration evidence exists. 29.The outsourcer shall be able to verify and provide documentation that staff members are complying with gowning, gloving, and glove-tip processes that are consistent with USP chapter standards. 30.The outsourcer shall perform routine surface microbiological and fungal environmental monitoring to minimize contamination on a minimum of a weekly basis. 31.The outsourcer shall perform comprehensive investigations of out-of-limit findings, as recommended by USP chapter, to determine root cause, followed by corrective and preventative actions on a minimum of a weekly basis. 32.The outsourcer shall perform nonviable and viable particle testing in primary engineering controls (e.g., laminar flow workbench, biological safety cabinet) and room air according to USP chapter standards (on a minimum of a weekly basis). 33.The outsourcer shall have a policy in place that requires validation of new or changed facilities, equipment, processes, container types, for sterility, and repeatability. 34.The outsourcer shall be able to provide documentation that confirms that sterile media used are certified by the manufacturer to be sterile and guaranteed to not promote growth. 35.The outsourcer shall provide detailed reports on the incidence of any positive media test results and the follow-up retests after corrective action is completed. 36.In assigning expiration and beyond-use dating, the outsourcer shall follow evidence-based and validated stability testing procedures to evaluate each preparation (drug, diluent and device/container) for: i. potency at room temperature or refrigerated temperature as applicable. ii. stability, based on a range of extreme temperatures per USP chapter guidelines, to ensure stability and determine the impact on the preparation (e.g. evaporation, precipitation, degradation, concentration). iii. chemical characteristics such as pH, particulate matter, color, sterility (container closure integrity testing). 37.The outsourcer shall provide a minimum guaranteed shelf life upon delivery. 38.The outsourcer shall have documented processes and procedures (including shipping validation studies) to ensure that preparations leaving the site retain their integrity and stability through the shipping cycle. Medication Administration Safety Features 39.The outsourcer shall provide readily accessible information regarding status of latex, bis (2-ethylhexyl) phthalate (DEHP), and preservatives in the preparations they prepare. 40.The outsourcer shall strive to provide quality packaging ad labeling in accordance with cGMP (e.g. drug name differentiation in the form of TALLMAN lettering, visual cues to differentiate drug names and concentrations, auxiliary labeling to indicate contraindicated routes of administration). 41.The outsourcer shall offer tamper-evident options which may include overwrap, shrink wrap, tamper-evident foil, and/or tamper-evident caps. 42.The outsourcer shall be able to compound products in the containers types (e.g., syringes, minibags, pump-specific cassettes) to meet the needs of VA TVHS. 43.The outsourcer shall have business continuity plans in place in the event of a natural or man-made disaster or public health emergency. 44.The outsourcer shall be able to compound medications for intrathecal administration. 45.The outsourcer shall be able to compound controlled substances. 46.The outsourcer shall be able to provide guaranteed timeframes for compounded sterile preparations. 47.The outsourcer shall be able to provide next day delivery, trackable by signature-receipt. 48.The outsourcer s current production capacity shall be able to meet the requirements of VA TVHS. 49.The outsourcer shall have a mechanism to respond to customer service issues or questions 24 hours a day, 7 days a week. 50.The outsourcer shall have a written Disaster Emergency plan for the provision of services in the event of loss of utilities. 51.The outsourcer shall have clinical expertise as documented/verified by PCAB accreditation in the area of products provided. 52.The outsourcer shall meet all requirements of and be in full compliance with the Drug Supply Chain Security Act (DSCSA). The outsourcer shall be required to comply with the provisions of the DSCSA for the tracing of products through the pharmaceutical distribution supply chain and all documentation requirements therein. B. PROCEDURES: 1.Service Hours: i. Compounding services shall be available for a minimum of 5 days (40 hours) per week. 2.Ordering of Compounding Products: i. All orders for compounded products will be initiated pursuant to a valid prescription from a VA TVHS provider for a product that is NOT commercially available and/or cannot be currently obtained from a commercial source. ii. Compounding prescription orders will be transmitted to the contractor via facsimile from the VA TVHS pharmacy service, except for controlled substances where a signed hard copy is required. 3.Order Processing/Preparation: i. All products will be labeled with the following information: a. Drug name(s), strength(s), and amount(s) b. Beyond use date (and time if applicable) c. Manufacturer s lot numbers for all ingredients d. Patient s name e. Patient s location (if currently inpatient) or address f. Directions for use and any applicable cautionary statements, either on the label or attached as an accessory label 4.Order Delivery: i. The compounded product(s) shall be delivered directly to the patient EXCEPT when the product is for administration at VA TVHS. In both cases the product will be delivered to the appropriate location prior to the designated due date. ii. For all orders considered URGENT, the contractor shall make all reasonable efforts to prepare and deliver the preparation as quickly as possible C. TERM OF THE TASK ORDER: This task order is effective from the date of award and the terms of this contract shall be reviewed and amended, as necessary, at a minimum of an annual basis. This contract is subject to the necessity of compounding services pursuant to a valid patient-specific prescription for which there are no commercially available alternatives. D. REGULATIONS/STANDARDS: The contractor must perform the required work in accordance with all applicable USP, USP, American Society of Health-System Pharmacists, National Institute for Occupational Safety and Health (NIOSH), and Joint Commission standards. E. HHS/OIG: To ensure that the individuals providing services under the task order have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this task order. Further the Contractor is required to certify in its proposal that all persons listed in the contractor s proposal have been compared against the OIG list and are NOT listed. During the performance of this task order the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. F. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA. VA has recognized Locum Providers as entities that do not require a BAA with their contractors as long as they are conducting health care on VA s behalf Pharmacist qualifies as a medical service therefore, no BAA is required. G. CONFIDENTIALITY OF PATIENT RECORDS The Contractor, as a VA provider, will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA provider for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical record information including patient treatment information pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the task order, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. H. RECORD KEEPING The Pharmacy office shall have a recordkeeping system of prescriptions compounded by the contractor. The Pharmacy office will be responsible for verifying all work performed by the contractor. The monthly listing of prescriptions compounded will be submitted by the COR s to the Chief, Pharmacy Service s office. Additionally, the responsible Pharmacy Supervisor will regularly monitor through direct and onsite observation that the contractor is performing the duties as described in the contract. I. VA PAYMENT: Contractor will be required to furnish an itemized invoice listing for the period of service covered. Invoices may be submitted as of the last day of each month, but no later than the 10th day of the following month services were provided. All invoices shall reference the appropriate obligation number and be sent to the following address: Invoices are to be submitted to: Department of Veterans Affairs VA FSC FMS-626 PO Box 149971 Austin TX 78714-8971 A copy of all invoices submitted to the Austin FSC shall also be provided to the Chief, Fiscal Service (04), VA Medical Center, Tennessee Valley Healthcare System, 3400 Lebanon Pike, Murfreesboro, TN 37129. J. EVALUATION FACTORS: (a) The Government will award a task order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. PCAB Accreditation Distance from VA Tennessee Valley Healthcare System (TVHS) Ability to perform requested high risk sterile compounds and deliver as requested. Past performance/experience 3 references must be submitted for all candidates for evaluation. Price PCAB Accreditation, distance from TVHS, ability to supply needed products timely, and Past Performance/Experience when combined are significantly more important than Price.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/36C24918Q9392/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24918Q9392 36C24918Q9392.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4273992&FileName=36C24918Q9392-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4273992&FileName=36C24918Q9392-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04908338-W 20180504/180502231147-600e45a500bcdf710910496f109055e3 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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