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S--RESTROOM GROUT CLEANING AND RESTORATION

Department of Veterans Affairs, Nashville VAMC | Published August 22, 2016  -  Deadline September 12, 2016
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The VA Tennessee Valley Health Care System VAMC Nashville and Murfreesboro has a need for restroom grout cleaning and restoration. The NAICS code is 561720 and the PSC is S201. This solicitation will be posted on or about August 23, 2016 and set aside for service disabled veteran owned small business (SDVOSB). The restoration/application/cleaning of the tile and grout areas shall provide the facility with tile and grout that shall look refreshed and be maintainable with "Green" products. The proposed contract will cover performance periods that include a base period plus four (2) one year options. Period of Performance will be: Base Year - October 1, 2016 to September 30, 2017 Option 1 - October 1, 2017 to September 30, 2018 Option 2- October 1, 2018 to September 30, 2019 All SDVOSBs are encouraged to view the solicitation and submit a quote.

Cordell Hull Lake O&M Services

Department of the Army, U.S. Army Corps of Engineers | Published November 23, 2015
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The Nashville District U.S. Army Corps of Engineers (USACE) has awarded a firm fixed-price requirements service contract with a base and four (4) option years for operation and maintenance services at Cordell Hull Lake based on response to solicitation W912P5-15-R-0016. Cordell Hull Lake is located on the Cumberland River in middle Tennessee about 60 miles east of Nashville. The areas of work are located in Smith and Jackson counties in Tennessee. Principal cities in the area are Carthage and Gainesboro, Tennessee. The Contractor shall furnish all necessary management, supervision, inspection, personnel, materials, supplies, parts, tools, equipment, transportation, and vehicles, except as otherwise provided for herein, required to perform the operation and maintenance services within the area of responsibility (including drainage area) of the Cordell Hull Lock and Dam Project hereafter, referred to as Cordell Hull Lake. Operation and maintenance services include but are not limited to: 1. Grass mowing (approximately 4,000 acres annually); 2. Cleaning services (includes litter pickup, camp sites, picnic sites and shelters, restrooms, washhouses, and sanitary dump stations); 3. Janitorial services (approximately 50,190 sq. ft of building space); 4. Facility repair, maintenance, and other non-routine services (includes a DBA wage rate section and a SCA wage rate section. The DBA section includes various equipment and carpenter, concrete finisher, electrician, equipment operator, laborer, mason, painter, plumber, and truck driver. The SCA section includes various equipment and laborer, general maintenance worker, carpenter, painter, electrician, plumber, welder, truck driver and equipment operator.); 5. Beach and playground maintenance; 6. Water Testing and Sand Filter Sewage Systems monitoring; 7. Marking and Painting Boundary Line 8. Herbicide Application; 9. Remote Area Cleaning; and 10. Pavement Striping.

Old Hickory Lake O & M Requirements Contract

Department of the Army, U.S. Army Corps of Engineers | Published January 6, 2016  -  Deadline February 16, 2016
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The Nashville District U.S. Army Corps of Engineers (USACE) anticipates a requirement for a firm fixed-price requirements contract with a nine (9) month base and four (4) option years for operation and maintenance services at Old Hickory Lake. Old Hickory Lake is located on the Cumberland River approximately 25 miles upstream from Nashville, Tennessee. The areas of work are located in Sumner, Wilson, Trousdale, and Davidson counties of Tennessee. Principal cities in the areas are Hendersonville, Gallatin, Mt. Juliet, Old Hickory, Hermitage and Hartsville Tennessee. Old Hickory Lock and Dam is located on mile 216.2, and the Visitor's Center, Resource Manager's Office, Shop Office and Operations Area, and Contract Administrator's Office are located in close proximity to Old Hickory Dam in Hendersonville, Tennessee. The Contractor shall furnish all necessary management, supervision, inspection, personnel, materials, supplies, parts, tools, tool related hardware, equipment, transportation, vehicles, and fuel except as otherwise provided herein, required to perform mowing, cleaning, janitorial, and other maintenance and operations services at the Old Hickory Lake project recreation areas, as specified and in strict accordance with all Terms, Conditions, General, Specific and Technical Provisions, Drawings, Attachments, Exhibits, Tables, etc., contained herein or incorporated by reference. Incorporation by reference shall include any and all mandatory provisions required by the Federal Acquisition Regulation (FAR) whether it is referenced or not referenced, current at time of award. This description is not intended to be all encompassing and is subject to change. The solicitation package will be available on or about Wednesday, January 20, 2016. A site visit is scheduled for Friday, January 29, 2016, starting at 9:00 a.m. Central Standard Time (CST). All contractors are to meet at the Old Hickory Lake Resource Manager's Office, which is located at #5 Power Plant Road, Hendersonville, TN 37075. For directions to the meeting location, please contact Tommy Mason at (615) 822-4846. REQUIREMENT TO REGISTER TO ATTEND SITE VISIT: Only registered persons will be permitted to attend the site visit. In addition to the below information, please also provide the name of firm, firm's CAGE and/or DUNS number, and name and position title of primary point-of-contact and their telephone number and email address. Only two persons from each business entity will be permitted to attend. U.S. CITIZENS: To register, U.S. citizens interested in attending the site visit must submit a Nashville District (LRN) Security Access Form to the Point of Contract (POC), Contract Specialist Kristal Jones by email to Kristal.R.Jones@usace.army.mil no later than five (5) days prior to the site visit. If submitting the form in less than five days, the person may not receive approval for participation. Notification of approval or denial will be provided prior to the date of the site visit. Foreign Nationals (FNs): FNs wishing to attend the site visit shall submit a completed LRN FN Security Form and legible color copies of two of the following documents: Passport (unexpired or expired), Certificate of U.S. Citizenship (INS Form N-560 04 N-561), Certificate of Naturalization (INS Form N- 550 or N-570), unexpired foreign Passport with I-551 stamp or attached INS Form I-94 indicating unexpired employment authorization, an Alien Registration Receipt Card with photo (INS Form I-151 or I- 551), unexpired Temporary Resident Card (INS Form I-688), unexpired Employment Authorization Card (INS Form I-688A), unexpired Reentry Permit (INS Form I-327), unexpired Refugee Travel Document (INS- Form I571), or unexpired Employment Authorization Documentation issued by the INS which contains a photograph (INS Form I-688B) to the LRN POC. These documents must be submitted two (2)weeks prior to the site visit. Exceptions will be considered on a case by case basis but will be limited. Any questions regarding this acquisiton MUST be submitted in writing via e-mail to Contract Specialist Kristal Jones at Kristal.R.Jones@usace.army.mil.

Natchez Trace Parkway 1A15, B10

Department of Transportation, Federal Highway Administration (FHWA) | Published January 4, 2016  -  Deadline February 18, 2016
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Sealed bids from all business concerns will be accepted for the Natchez Trace Parkway Project FTNP-NATR 1A15, B10, Solicitation Number DTFH71-16-B-00015, located in Williamson and Davidson Counties, Tennessee. The project consists of the rehabilitation and resurfacing of approximately 19 miles of the Natchez Trace Parkway, from Milepost (MP) 423 to MP 442, including pull-offs, parking areas, bridges, and exit/entrance ramps. The work includes asphalt pavement milling, full-depth pavement patching, asphalt pavement widening, crack cleaning and sealing, shoulder reconditioning, asphalt concrete pavement overlay, and other miscellaneous work. The project will be split into multiple work schedules/contract options, with the cost of the entire project expected to fall within the price range of $2,000,000 to $5,000,000. Bid documents should be issued on or about January 18, 2016. Bid due date and location will be specified on the SF 1442, Block 13a of the Solicitation. Use Internet address https://www.fbo.gov/ (at QUICK SEARCH, type "EFLHD" and all available projects will be listed) to check for availability of bid documents. All bid documents can be directly downloaded from these websites. Documents will no longer be mailed. Register to receive Email Notification to automatically be notified when a document is added or updated for a specific project. If firms do not register as an interested vendor at the Federal Business Opportunities website, there will be no Plan Holders List. Annual Representations and Certifications FAR 52.204-8 (Dec 2014). The Representations and Certifications must be filled-in online at http://sam.gov/. The required Annual Form Vets-4212 must also be filled-in online at http://www.dol.gov/vets/vets4212.htm per FAR 52.222-37. Please send all questions concerning construction projects to eflhd.contracts@dot.gov. Include the solicitation number, project name and number, requesting firm and address, a point of contact and telephone number. Requests for 'faxing' or overnight mailing will not be accepted. ATTENTION Minority, Women-Owned, and Disadvantaged Business Enterprises (DBEs) The Department of Transportation (DOT) offers working capital financing assistance for transportation related contracts. The DOT's Short-Term Lending Program (STLP) offers lines of credit to finance accounts receivable. Maximum line of credit is $750,000 with interest at the prime rate. For further information, call (800) 532-1169 or 202-366-1930. Internet address: http://osdbuweb.dot.gov IMPORTANT PAYMENT REQUIREMENT In accordance with Federal Acquisition Regulation (FAR) Subpart part 4.1102, prospective contractors shall be registered in the System for Award Management (SAM) database prior to award of a contract. Also FAR clause 52.232-33 requires SAM registration for payment. SAM registration is available online at the following Internet web address: www.sam.gov. IMPORTANT SUBCONTRACTING PLAN REQUIREMENTS Required from all "other than Small business" when requirement is expected to exceed $700,000 ($1,500,000 for construction) [FAR 19.702]. Contracting Officer, Contracting Officer's Representative, and Small Business Specialist are responsible for approving a reasonable and realistic plan [FAR 19.705-4] [TAM 1219.201(e)(6)]. Legislated subcontracting goals [15 USC 644(g)(1)]: 44% - Small Businesses (SB), 5% - Small Disadvantaged Businesses (SDB), 5% - Women-Owned Small Business Entities (WOSB), 3% - HUBzones, 3% - Service-Disabled Veteran-Owned Small Businesses (SDVOSB). A copy of each subcontracting plan (or contractor statement that no subcontracts are to be awarded) must be provided to Eastern Federal Lands and approved by the Office of Small Disadvantaged Business Utilization prior to close of negotiations (or award of the IFB) [TAM 1219.705-5 and -6]. PLEASE NOTE For security reasons, individuals requiring access to the EFLHD must present a valid photo ID and be escorted to their destination by a Government employee. Due to new security provisions, all visitors attending bid openings are urged to arrive at least 1 hour prior to the scheduled bid opening. All visitors must register with the receptionist in Room 100. A Government employee will collect the bids. Prior to bid opening, a Government employee will escort all bidders to the bid opening. Unescorted visitors will be denied entry and no exceptions will be made.

Q--COMPOUNDING MEDICATION SERVICES FOR THE VA MEDICAL CENTER TENNESSEE VALLEY

Department of Veterans Affairs, Nashville VAMC | Published May 8, 2015  -  Deadline May 13, 2015
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This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Solicitation; quotes are being requested and a written Solicitation will not be issued. Solicitation number VA249-15-Q-0485 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. This requirement is a Total Small-Business Set Aside only qualified offers may submit bids. The NAICS is 446110 and the small business size standard is $27.5. In order to be considered for a government award, the firm must be registered in SAM @ www.sam.gov. Description of Services: The government anticipates awarding a Firm Fixed Price award. The bases of award will be Lowest Price Quote. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation requirements and will provide the best value to the government. The Tennessee Valley Healthcare System (Murfreesboro and Nashville Campuses) VA Medical Center is seeking compounding medication Services with a Base Year plus Four (4) one-year option periods to renew. The Offeror is required to provide specialty distributed 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 are not available from commercial source and are pursuant to a valid VA TVHS patient-specific prescription. The preparation of all sterile products shall be in compliance with United States Pharmacopoeia (USP) Chapter standards and federal, state, and other regulatory requirements as described herein. See Statement of Work. Period of Performance: Base Year with four (4) one-year option periods to renew. Place of Performance: Tennessee Valley - Nashville Campus, 1310 24th Avenue South, Nashville TN 37212 and Alvin C. York Campus, 3400 Lebanon Pike, Murfreesboro, TN 37212 Quote Submission: Contractor shall submit their quote on company letterhead and shall include unit price, total , unit qty and item description as specified above, as offered discounts, proposed delivery time, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov, terms of any express warranty, unit price, overall total price, applicable shipping charges, completed copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document. All prospective bidders must include appropriate references which must include all applicable company information. PLEASE NOTE: That all prospective bidders must have accreditation through the Pharmacy Compounding Accreditation Board (PCAB) and submit documentation indicating such. All quotes received without this documentation will not be considered. The offeror shall provide sufficient evidence that they possess adequate resources, capability, experience, responsibility and integrity to meet the technical capabilities to comply with the requirements of the resulting contract. The offeror must provide past performance evidence. Past performance will be evaluated on an "acceptable" or "unacceptable" basis using the ratings in the table below based on the answers to the above capabilities questionnaire. The past performance evaluation results is an assessment of the offeror's probability of meeting the minimum past performance solicitation requirements. This assessment is based on the offeror's record of relevant and recent past performance information that pertain to the products and/or services outlined in the solicitation requirements. Past performance information may be obtained through other sources known to the VA and the Federal Government. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past. Therefore, the offeror shall be determined to have unknown past performance. In the context of acceptability/unacceptability "unknown" shall be considered "acceptable." All questions regarding this solicitation must be submitted to the Contract Specialist in writing by e-mail to Scheronica.Cochran@va.gov no later than 8:00 AM CST, May 12, 2015. All responses to questions will be incorporated into a written amendment posted to the Federal Business Opportunities website (www.fbo.gov). Amendments to this Solicitation: Offerors are encouraged to monitor the Federal Business Opportunities website with respect to this solicitation because any amendments to this Solicitation will be posted on that website (www.fbo.gov). All Quotes regarding this solicitation must be submitted to the Contract Specialist in writing by e-mail to Scheronica.Cochran@va.gov no later than 8:00 AM CST, May 13, 2015. The subject line must specify VA249-15-Q-0485 - Service for Compounding Medications - TVHS. Quote/Proposal should be broken down as such: Base Year 05-15-2015 - 05-14-2016 $ Option Year 1: 05-15-2016 - 05-14-2017 $ Option Year 2: 05-15-2017 - 05-14-2018 $ Option Year 3: 05-15-2018 - 05-14-2019 $ Option Year 4: 05-15-2019 - 05-14-2020 $ Total For Base & Option Years $ Solicitation document and incorporated FAR and VAAR provisions and clauses apply to this acquisition: 52.204-7, Central Contractor Registration - title is now System for Award Management [SAM]. 52.204-9, Personnel Identity Verification of Contractor Personnel (Jan 2011) 52.212-1, Instructions to Offerors-Commercial 52.212-2, Evaluation-Commercial Items 52.212-3, Offeror Representations and Certifications-Commercial Items 52.212-4, Contract Terms and Conditions-Commercial Items 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items 52.217-8, Option to Extend Services 52.217-9 Option to Extend the Term of the Contract 52.219-6, Notice of Total Small Business Set-Aside 52.219-14, Limitations on Subcontracting (Nov 2011) 52.233-3, Protest after Award 52.222-3, Convict Labor 52.232-19, Availability of Funds for the Next Fiscal Year 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration 52.232-39, Unenforceability of Unauthorized Obligations 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 852.203-70, Commercial Advertising 852.203-71, Display of Department of Veterans Affairs Hotline Poster (Dec 1992) 852.232-72, Electronic Submission of Payment Requests 852.237-70, Contractor Responsibilities 852.270-1, Representatives of Contracting Officers Full text can be obtained at www.arnnet.gov/far DISCLAIMER AND IMPORTANT NOTES: The government is in no way obligated to do business with or enter into the award a contract to any firm or its affiliates or otherwise pay for the information provided in this synopsis. STATEMENT OF WORK FOR THE OUTSOURCING OF COMPOUNDED PRODUCT PREPARATION The contractor shall provide specialty distributed 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 are not available from commercial source and are pursuant to a valid VA TVHS patient-specific prescription. The preparation of all sterile products shall be in compliance with United States Pharmacopoeia (USP) Chapter standards and federal, state, and other regulatory requirements as described herein: A. DUTIES AND RESPONSIBILITES Specific Regulatory Compliance 1. The outsourcer shall have a state pharmacy license available where the compounding center resides. 2. If located outside the state of Tennessee, the outsourcer shall be licensed to ship to Tennessee. 3. 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 drug manufacturer with the Food and Drug Administration (FDA). 4. If the outsourcer prepares non patient-specific controlled substance preparations, the outsourcer shall be registered as a drug manufacturer with the Drug Enforcement Administration (DEA). 5. All pharmacists working for the outsourcer shall be licensed in the state where they are practicing. 6. 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. 7. The outsourcer meets or exceeds state required pharmacist-to-pharmacy technician ratios for the state in which the compounding center is located. 8. 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. 9. 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. 10. The outsourcer shall have the required minimum amount of product liability insurance as outlined by VA TVHS. 11. 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. 12. The outsourcer shall meet American Society of Health System Pharmacists (ASHP), National Institute for Occupational Safety and Health (NIOSH), and USP chapter guidelines for handling hazardous agents. 13. 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. 14. 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 . 15. The outsourcer shall immediately disclose any disciplinary or punitive action by any regulatory agency (e.g., FDA warning letter, state board of pharmacy). 16. The outsourcer shall be able to provide quality control history and quality assurance trend reports upon request. Quality and Patient Safety Measures 17. The outsourcer shall provide documentation that confirms staff competency (garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to compounding of actual drug preparations. 18. The outsourcer shall provide documentation that confirms that the outsourcer tests aseptic techniques by preparing media fill units per USP chapter standards. 19. The outsourcer shall provide documentation that confirms that pharmacists and pharmacy technicians are pre-qualified using media fills before compounding of actual drug preparations. 20. The outsourcer's staff shall be required to undergo re-qualification using media fills at a minimum of an annual basis 21. 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 corrective and preventative action. 22. The outsourcer shall provide customers with substantial evidence that supports extended expiration dating for compounded sterile preparations when BUD limits in USP are exceeded. 23. The outsourcer shall perform studies to determine extended expiration dates, using evidence-based and validated stability testing procedures, for compounded sterile preparations for which no extended expiration evidence exists. 24. The outsourcer shall be able to verify that staff members are complying with gowning, gloving, and glove-tip processes that are consistent with USP chapter standards. 25. The outsourcer shall perform routine surface microbiological and fungal environmental monitoring to minimize contamination on a minimum of a weekly basis. 26. 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. 27. 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). 28. The outsourcer shall have a policy in place that requires validation of new or changed facilities, equipment, processes, container types, for sterility, and repeatability. 29. 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. 30. 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. 31. 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). 32. The outsourcer shall provide a minimum guaranteed shelf life upon delivery. 33. 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 34. The outsourcer shall provide readily accessible information regarding status of latex, bis (2-ethylhexyl) phthalate (DEHP), and preservatives in the preparations they prepare. 35. The outsourcer shall strive to provide quality packaging ad labeling in accordance with cGMP (e.g. drug name differentiation in the form of TALL MAN lettering, visual cues to differentiate drug names and concentrations, auxiliary labeling to indicate contraindicated routes of administration). 36. The outsourcer shall offer tamper-evident options which may include overwrap, shrink wrap, tamper-evident foil, and/or tamper-evident caps. Service 37. 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. 38. The outsourcer shall have business continuity plans in place in the event of a natural or man-made disaster or public health emergency. 39. The outsourcer shall be able to compound medications for intrathecal administration. 40. The outsourcer shall be able to compound controlled substances. 41. The outsourcer shall be able to provide guaranteed timeframes for compounded sterile preparations. 42. The outsourcer shall be able to provide next day delivery, trackable by signature-receipt. 43. The outsourcer's current production capacity shall be able to meet the requirements of VA TVHS. 44. The outsourcer shall have a mechanism to respond to customer service issues or questions 24 hours a day, 7 days a week. 45. The outsourcer shall have clinical expertise as documented/verified by PCAB accreditation in the area of products provided. 46. As of July 1, 2015, the outsourcer shall meet all requirements of and be in full compliance with the new 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 to VA TVHS 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 , 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 monthly 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 monitor through 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. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Compounded Product Preparation, Tennessee Valley Healthcare Services (TVHS) Murfreesboro and/or Nashville, TN Contract Number: Contract Description: Furnish Patient-Specific Compounded Product Preparation Pharmacy services to the VA TVHS in accordance with the SOW. Contractor Name: 1.PURPOSE This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following: " What will be monitored " How monitoring will take place " Who will conduct the monitoring " How monitoring efforts will be documented This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government's responsibility to be objective, fair and consistent in evaluating performance. This QASP is a 'living document' and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities. 2. GOVERNMENT ROLES AND RESPONSIBILITIES The following personnel shall oversee and coordinate surveillance activities: a. Contracting Officer (CO) - the CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this document. The CO is ultimately responsible for the final determination of the adequacy of the contractor's performance. Assigned CO: , Contracting Officer Organization: Department of Veterans Affairs, VISN 9 Network Contracting Office b. Contracting Officer's Representative (COR) - the COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractors performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government's behalf. Assigned CORs: Steven Clause, TVHS Pharmacy Associate Chief and Reinaldo Mercado, TVHS Pharmacy Associate Chief c. Other Key Government Personnel: Diane Shackelford, TVHS Pharmacy Chief and Program Manager 3. CONTRACTOR REPRESENTATIVES The following employees of the contractor serve as the contractor's program manager for this contract: a. Program Manager: b. Other Contractor Personnel: 4. PERFORMANCE STANDARDS: Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Skills required in the Statement of Work (SOW) include performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). Contracted company will follow and meet all USP , American Society of Health-System (ASHP), FDA and DEA standards and requirements in addition to all requirements of this Statement of Work. BELOW IS A EXPLANATION FOR EACH CATEGORY. ________________________________________________________________________________________________________________________ Acceptable Method of Task ID Indicator Standard Quality Surveillance Incentive Level ________________________________________________________________________________________________________________________ Patient Care 1 Incident Reports/ Medication errors are to be No greater than 2 Reports signed If less than Quality of Care Medication Events minimized/eliminated by Managers acceptable, as occur company may not be used in future. ________________________________________________________________________________________________________________________Patient Care 2 Quality Citations Quality citations by State No more than 1 Published citations If less than Quality of Care or other regulatory agencies citation acceptable, should not occur and are company may addressed promptly when not be used in they do occur future. ________________________________________________________________________________________________________________________ Quality of Care 3 Patient and/or staff Patient/staff complaints No greater than 2 Complaints If less than Customer Satisfaction complaints reported are to be minimized/ received by acceptable, to Managers eliminated Managers as company may occur not be used in future. ________________________________________________________________________________________________________________________ Timeliness 4 Reports/observations Contract company No greater than 2 Complaints If less than of untimliness will provide requested instances received by acceptable, product at the requested Managers as company may time and place occur not be used in future. ________________________________________________________________________________________________________________________ Patient Care 5 PCAB Accreditation Contract company Zero instances PCAB website If less than will maintain PCAB acceptable, accreditation at all times company will not be used in future. __________________________________________________________________________________________________ J. REFERENCES 1. Outsourcing Sterile Products Preparation: Contractor Assessment Tool. Downloaded from: http://www.ashpfoundation.org/sterileproductstool. 2. Pharmaceutical compounding- sterile preparations (general information chapter 797). In: The United States pharmacopeia. 27th rev., and the national formulary, 22nd ed. Rockville, MD: The United States Pharmacopeia Convention, 2004:2350-70.
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