PHARMACEUTICAL WASTE REMOVAL
Added: Sep 10, 2010 7:25 pm 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 the notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation, VA-262-10-RQ-0519, is issued as a request for quotation. This solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) 01-20. If two (2) or more responsive, responsible and technically acceptable Service-Disable Veterans-Owned Small Business businesses or Veteran-owned small business respond, this acquisition will be set-aside for Service-Disable Veterans-Owned Small Business or Veteran-owned small business, if not, it will be unrestricted. The North American Industry Classification System is 562119 and the associated business size standard is $12,500,000. This request for quotation consists of the following: Contractor shall provide all labor, transportation, disposable containers, equipment, waste manifest and other required reports and supervision necessary to dispose of contents for the VA San Diego Healthcare System (VASDHS) as further defined in the Schedule. Pharmacy waste will be removed by the contractor at the point of accumulation. Also Contractor shall provide all labor, transportation, reusable containers for temporary storage of non-RCRA pharmacy waste, equipment, waste manifest or medical waste tracking document, and other required reports and supervision necessary to dispose of contents for the identified VASDHS facilities as further defined in the Schedule. Non-RCRA pharmacy waste will be removed by the contractor at Building 16. The consolidated Non-RCRA pharmacy waste will be collected bi-monthly by a Registered Medical Waste Transporter and disposed at a Medical Waste Incinerator. Certificates of Destruction must be provided monthly to the VASDHS. BASE YEAR PERIOD: 10/01/10 - 9/30/11 Item No. DESCRIPTION EST. QTY UNIT UNIT PRICE TOTAL AMOUNT 001 Non-Hazardous Pharmaceutical Waste 27,800 LB $ $ Total Estimated Amount for Base Year $ OPTION YEAR ONE: 10/01/11 - 9/30/12 Item No. DESCRIPTION EST. QTY UNIT UNIT PRICE TOTAL AMOUNT 001 Non-Hazardous Pharmaceutical Waste 27,800 LB $ $ Total Estimated Amount for Option Year One $ OPTION YEAR TWO: 10/01/12 - 9/30/13 Item No. DESCRIPTION EST. QTY UNIT UNIT PRICE TOTAL AMOUNT 001 Non-Hazardous Pharmaceutical Waste 27,800 LB $ $ Total Estimated Amount for Option Year Two $ OPTION YEAR THREE: 10/01/13 - 9/30/14 Item No. DESCRIPTION EST. QTY UNIT UNIT PRICE TOTAL AMOUNT 001 Non-Hazardous Pharmaceutical Waste 27,800 LB $ $ Total Estimated Amount for Option Year Tee $ OPTION YEAR FOUR: 10/01/14 - 9/30/15 Item No. DESCRIPTION EST. QTY UNIT UNIT PRICE TOTAL AMOUNT 001 Non-Hazardous Pharmaceutical Waste 27,800 LB $ $ Total Estimated Amount for Option Year Four $ AGGREGATE ESTIMATED TOTAL PRICE: $ DESCRIPTION OF SERVICES/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF WORK: The intent of this Request for Quote is to establish a Firm-Fixed Price contract to provide non-hazardous pharmaceutical waste to a Medical Waste Incinerator removal services. The Contractor shall provide all necessary labor, materials, equipment, transportation, facilities, supplies, waste manifests and other reports necessary to collect, analyze, prepare, package, label, remove, transport, store, treat and dispose of non-hazardous pharmaceutical waste under the resulting contract in accordance with the terms, conditions, provisions, and specifications and in accordance with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and all Federal, State, and Local requirements of this solicitation. All supplies and services are to be furnished F.O.B. destination for the base period of one year with the Government's option to extend the contract services for four (4) additional one-year option periods. The quantities shown in the schedule are estimates of the end user's annual requirements. There is no express or implied guarantee that these quantities other than the minimum order stated in FAR 52.216-19 Order Limitations (a) will be utilized. Prices listed in the schedule are to be all inclusive for services and supplies provided. Additional charges such as delivery fees, environmental fees, hazardous waste fees, fuel surcharges, etc. shall NOT be billed for, or collected from the Government for orders received under this contract. APPLICABLE PUBLICATIONS: The contractor shall be responsible for complying with all publications, including but not limited to those identified below, in effect at the time of the proposal and all future updates: All Non-Resource Conservation and Recovery Act (RCRA) pharmaceutical waste will be transported, managed, and disposed by the contractor. The following documents are among those applicable to the tasks required by this contract (should any aspect of the regulations conflict, the most stringent shall apply): California Health and Safety Code, Sections 117600-118360, Medical Waste Management Act (including all definitions) Hazardous Materials Regulations, MRE: 49 CFR parts 171 tough 180, Department of Transportation Code of Federal Regulations, Hazardous Waste Criteria, 40 CFR 261 (C) (D), 40 CFR262 and 21 CFR 1200-1316 PARTICIPATING FACILITIES/SITES: VA San Diego Healthcare System Mission Valley Clinic 3350 La Jolla Village Drive. Building 16 8810 Rio San Diego Drive San Diego, CA 92161 San Diego, CA 92108 Oceanside Clinic Chula Vista Clinic 1300 Rancho Del Oro 835 Third Avenue Oceanside, CA 92056 Chula Vista, CA 91910 VA clinics associated with but not located on a main campus will require pharmaceutical waste pick-up and disposal on a 90 day schedule; pricing will be the same as the main facility. Clinic locations and estimated quantities are subject to change due to patient demand, Congressional funding or other factors beyond the control of The Department of Veterans Affairs. ESTIMATED QUANTITY: The estimated number of pounds of Non-RCRA pharmaceutical waste per year per VASDHS Facility is: VA San Diego: 26,000 lbs Oceanside Clinic: 800 lbs Mission Valley Clinic: 800 lbs Chula Vista: 200 lbs Price for containers shall include a comprehensive management program for classification of all items in pharmacy formulary as well as classification of new items within 14 calendar days of notification by the Contracting Officer's Technical Representative (COTR). The formulary waste classification will be maintained in computer accessible file preferably internet accessible. Whenever there is a regulatory change affecting the fate of formulary, an update of the formulary classification will be provided to the pharmacy department when 30 days of a regulatory change. Reports on poundage pick-up non hazardous pharmaceutical and waste containers will be bar coded in such a way as to allow for tracking of containers including but not limited to a history of the net weight of material collected, the time a container stayed at point of accumulation, the date the full waste container was replaced and the number of times the reusable container has been reused. This history will be maintained in a software database available for review and compilation of statistics. The consolidated weight of non-hazardous pharmaceutical waste collected from waste accumulation points will include the date of accumulation and removal from a specific medical center or clinic. The weight will be recorded on the non-hazardous pharmaceutical waste receipt as well on a separate electronic database. CONTRACT COVERAGE: The following categories of waste are subject to this contract: Non- Resource Conservation and Recovery Act (RCRA) pharmaceutical wastes: (a) "Pharmaceutical" means a prescription or over-the-counter human or veterinary drug, including, but not limited to, a drug as defined in Section 109925 or the Federal Food, Drug, and Cosmetic Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)). (b) For purposes of this part, "pharmaceutical" does not include any pharmaceutical that is regulated pursuant to either of the following: (1) The federal Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C.A. Sec. 6901 et seq.). (2) The Radiation Control Law (Chapter 8 [commencing with Section 114960] of Part 9). CONTRACTOR SPECIFIC TASKS: The Contractor shall provide all labor and equipment for the non-hazardous pharmaceutical waste pick-up at 3350 La Jolla Village Drive, 92161; Building 16, and shall be responsible for disposing of all non-hazardous pharmaceutical waste as per the NIST 800-88 (NSA-EPL). All transport and disposal may be witnessed by a VA employee or an authorized Contractor employee (authorized by the COTR) to witness destruction by incineration of non-hazardous pharmaceutical waste and any sensitive VA material attached. After the destruction/incineration of the non-hazardous pharmaceutical waste, the Contractor will provide a certificate of destruction to the VASDHS Privacy Officer and the COTR. Contractor is responsible for maintaining liability insurance for the duration of the contract and for following all pertinent federal and state regulations with regard to transportation and destruction of classified / confidential documentation. The contractor certifies that all data will be protected until final destruction. The contractor shall be the point of contact for liability should an incident occur (for mitigation purposes) after the data is picked up by the contractor. Delivery/Pick-up frequency shall be at least twice a month at the La Jolla Facility and every 90 days at the tee clinics. No guarantees are made as to the estimated pick up and delivery frequencies or volumes, or the quantities of bulk non-hazardous pharmaceutical waste. The estimate information provided in the scope of work is based on historical data. The locations for the bulk containers are subject to change by the Government. The Government shall notify the contractor of location changes within five working days of any changes. The contractor will be available for emergency pick-ups. The contractor agrees to abide by the following references: NIST 800-88 (EPL) 1x5 mm cross cut (as stated in Para. a below), 41 CFR Part 101-45 and 44 U.S.C. 3302 § 1228.58. Incinerator Specifications: The Contractor shall provide off-site pharmaceutical waste destruction. The pharmaceutical waste shall be destroyed by incineration. Protected information contained on any pharmaceutical waste material must be destroyed in such a manner that is compliant with the National Institutes of Standards and Technology (NIST) Special Publication 800-88; incineration, pulping, mastration, or sedding to NSA EPL 1x5mm. Pharmaceutical waste that contains Personal Identifiable Information (PII) or Protected Health Information (PHI) must be destroyed by burning in the medical waste incinerator at a minimum of 1500oF as a final destruction method. The pharmaceutical waste which contains PII or PHI shall not be abandoned, sold or resold. Note: If the Contractor has to move the pharmaceutical waste containing PII data to the disposal site away from the VASDHS, this is authorized. The Contractor accepts liability for all data and the ramifications should a loss of data occur; the VASDHS is harmless should an incident occur after the Contractor takes possession of the data attached to the non-hazardous pharmaceutical waste. No Personal Identifiable Information or Sensitive information will ever be place in an un-authorized dumpster or similar device, until it has been compliant burned. The Contractor agrees to destroy all VASDHS pharmaceutical waste IAW federal laws and the Contractor shall ensure that PII and other sensitive temporary records (in the pharmacy waste containers provided by the Contractor) are protected until their contents of pharmaceutical waste is actually destroyed by burning in a medical waste incinerator at minimum of 1500oF. Intermittent / Emergency Orders: In the event that additional pharmacy waste pickups are needed, the contractor shall be available within 48 hours notice to respond for unscheduled service and prices shall be in accordance with the fee that is listed in the contract schedule. Control of Security Waste: Contractor shall be responsible for the management, oversight, security, and control of all classified, sensitive, confidential documents and documents containing medical records stored in the pharmacy waste containers, prior to and until completion of destruction by burning in a medical waste incinerator at a minimum of 1500oF. The contractor is culpable under the law should an employee view, take or release sensitive information unlawfully. Pharmacy Waste Containers: The contractor shall pick-up the required number of pharmacy waste containers for destruction. The pharmacy waste containers shall be stored in the locked temporary storage facility-Building 16 as directed by the COTR. The containers shall be kept in the locked temporary storage facility - Building16. CERTIFICATION OF DESTRUCTION The Contractor shall prepare and submit to the medical facility's COTR an original signed Certificate of Destruction (witnessed by a VASDHS employee or a designated Vendor representative assigned in writing by the COTR) for each pick up for each site within tee (3) working days of each pick up. The contractor shall maintain proper records concerning each Certificate of Destruction issued. The Certificate of Destruction shall as a minimum contain the following: Pick-up/Delivery Location Pick-up/Delivery Date Name of Government COTR at Pick-up Location Amount of pharmaceutical waste (# of containers picked up and pounds) Destruction Certification Document Number Destruction Certification Date Any other information as determined necessary by the Security Officer ACTIVITY LOGS/REPORTS: The Contractor shall maintain and provide invoice services accomplished at each site. One copy of the invoice shall be provided to the COTR on the last day of each month. SITE VISIT: Offerors will be given the opportunity to conduct an on-site inspection prior to submitting an offer. There will only be one on-site inspection scheduled. Site visit for VA San Diego will be on September 15, 2010_ at _07:00 a.m. Meet at: _VASDHS Main Entrance for Visitor's Badge Identification. CONTRACTOR PERSONNEL: The Contractor shall provide qualified employees. The Contractor shall be required to comply with all VHA security requirements. The Contractor shall be responsible for coordinating with the COTR and providing all information required of employees for performance of work. All security requirements must be met and employees cleared prior to the contractor performing work under the contract. Employees that cannot meet the security and clearance requirements shall not be allowed to perform work under this contract. CONTRACTOR VEHICLES: All Contractor vehicles utilized in this contract shall be insured and maintain current state vehicle registration. All Contractor employees shall possess a valid State Driver's license and have no traffic violations on his/her driving record. The Contractor or his/her employees while performing under this contract may use personal vehicles that have been registered with the SDVAHS police. QUALITY CONTROL: The contractor shall develop and maintain quality programs to ensure refuse, transport, and treatment services are performed in accordance with commonly accepted Commercial practices. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. As a minimum the contractor shall develop quality control procedures addressing the areas when the Acceptable Quality Level is not met. QUALITY ASSURANCE: The Government may annually inspect the transport and treatment of the pharmaceutical waste, which will be accomplished by the information security officer or privacy officer, contracting officer technical representative; the Government may increase the number of quality control inspections if deemed appropriate because of repeated failures discovered during quality control inspections. Likewise, the Government may decrease the number of quality control inspections if performance dictates. The Government will also receive and investigate complaints from various customers located at the business locations. INSURANCE LIABILITY: (a) Workers Compensation and Employer's Liability: The contractor is required to comply with applicable Federal and State worker's compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $1,000,000 shall be required. (b) General Liability: (1) The contractor is required to maintain bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence. (2) The contractor will be responsible for all damage to property, which may be caused by him, or any employee engaged in the performance of this contract. (c) Automobile Liability: The contractor is required to maintain automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operated in the U.S. shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims. (d) Before commencing work under this contract, the contracting officer may require the contractor to furnish certification from his insurance company indicating that the coverage outlined in paragraphs (a) and (b) and (c) has been obtained and that it may not be changed or canceled without a guaranteed thirty (30) days notice to the contracting officer. The contracting officer may waive the requirement if it is determined that insurance certifications now on file are acceptable, however, new certifications shall be furnished prior to the expiration date. NORMAL WORK HOURS: The scheduled date for pharmacy waste pickups is currently bi-monthly on Fridays at 07:00 a.m. This contract may include additional pickups, based on volume, between the hours of 7:00 a.m. and 3:00 p.m. Monday tough Friday, National Holidays excluded. Any service performed during other than normal work hours shall be approved in advance by the Contracting Officer Technical Representative (COTR) at a price agreed to by the Contractor and Contracting Officer to be paid from separate contract or purchase order. National Holidays: The Contractor is not required to provide services on the following National Holidays nor shall the Contractor be paid for these National Holidays. New Year's Day 1 January Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Independence Day 4 July Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day 11 November Thanksgiving Day 4th Thursday in November Cistmas Day December 25 Also included would be any other day specifically declared by the President of the United States to be a National Holiday. When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday. PICK-UP SCHEDULE: Each offeror will submit a proposed pick-up schedule for non-RCRA pharmaceutical waste with the quote. The scheduled dates for pick-up are currently Friday between the hours of 07:00 a.m. to 3:00 p.m. IDENTIFICATION BADGE: Contractor personnel on VA property must comply with the VA security management program. Contractor personnel shall wear a company I.D. badge at all times while on VA property. Contractor personnel shall check in with Environment Health & Safety (EHS) upon arrival to pick-up a VA I.D. badge and upon completion, shall check-out with EHS. PARKING: Park only in areas designated by the COTR or otherwise directed by Police and Security Service personnel. The Contractor shall display on its vehicles the company name in a manner and size that is clearly visible. The Contractor shall conform to the posted speed limits and parking restrictions set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction the offenses will be handled in Federal Court as they are Federal offenses. VA will not validate or make reimbursement for parking violations of the contractor's personnel under any circumstance. TRAVEL: Transportation charges for contractor's service personnel shall not be billed or paid under the resulting contract. AUTHORIZED SERVICES: Only those services specified herein are authorized under this contract. Prior to performing any service of a non-contract nature, the Contracting Officer must be advised of the reasons for this additional work. Only the Contracting Officer may authorize additional services and reimbursement will not be made unless prior authorization has been obtained. SMOKING POLICY: Smoking is permitted only in designated areas which vary at individual VASDHS sites. MATERIALS DATA SAFETY SHEETS (MSDS): The Contractor shall provide their employees with immediate access to MSDS for all hazardous substances. CONTRACTOR'S PERSONNEL: The Contractor is responsible for the proper protection of his employee. Attire and Personal Protective Equipment (PPE), including respirators, must be appropriate for the hazardous condition of lab-packing, lifting, carrying, pouring, blending, moving, and/or loading hazardous and toxic substances in limited space. The Contractor shall furnish Contractor employees all necessary PPE and ensure proper working condition of said equipment. Contractor employees shall be enrolled, as appropriate and at Contractor expense, in a medical surveillance program as prescribed by 29 CFR 1910. The Government reserves the right to accept or reject Contractor personnel for the rendering of services. Complaints concerning Contractor personnel performance or conduct shall be dealt with by the Contractor. In addition, the parties agree that the contractor's personnel working as a result of this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor. The contractor shall be responsible for providing: 1. Workers Compensation. 2. Professional liability insurance. 3. Health examinations. 4. Income tax withholding, and, 5. Social Security payments. PENALTIES AND FINES: The Contractor shall satisfy all applicable regulatory agency requirements. In the event a regulatory agency assesses a monetary fine against the Government for violations caused by the Contractor, the Contractor shall reimburse the Government for the amount of the fine. GOVERNMENT FURNISHED PROPERTY AND SERVICES: The Government will provide designated areas for placement of disposal pharmaceutical waste containers. However, the Contractor shall not restrict any VA facility from performing packaging or consolidation of any facility's own waste stream, nor restrict any VA facility to contractor provided packaging as long as said packaging or consolidation complies with applicable government regulations. In accordance with applicable government regulations, the designated VA representative will complete appropriate information on and/or sign required waste manifest forms. The Government will provide appropriate facilities for any training provided by the Contractor. CONTRACTOR FURNISHED PROPERTY AND SERVICES: The Contractor will provide (based upon a needs assessment and at no cost to VASDHS) pharmacy waste collection bins which should be 44 gallon containers or larger. The Contractor will furnish DOT approved waste containers appropriate for collection and transport of non hazardous pharmaceutical waste. Non hazardous pharmaceutical waste containers will be re-usable upon emptying and cleaning of containers in accordance with any applicable state and federal regulations. Containers will incorporate environmentally preferable recycled materials consistent with the Veterans Administration's Green Environmental Management System (GEMS) program. The contractor shall ensure that all recyclable waste containers are maintained in optimum condition. SERVICE CALLS: Contractor shall provide in the space below, the name, location, and telephone number of the office where service calls are to be placed: Name: Address: Telephone: Email: TRAINING: Contractor will provide training on reusable pharmaceutical containers, classification and segregation of pharmaceutical waste as part of the service. Any additional training shall be approved in advance by the Contracting Officer Technical Representative (COTR) at a price agreed to by the Contractor and Contracting Officer to be paid from separate contract or purchase order. SPILLS: When waste is spilled by the Contractor at any pickup site, storage location or during transport, the Contractor shall be responsible, at no additional charge to the Government, for clean-up in accordance with appropriate state and federal regulations. In addition, a verbal report shall be made immediately to the COTR, followed by a written report within 7 business days. The written report will include the following: " Spills by type and amount of waste " Certification spill waste was properly removed " Identity of personnel exposed to spilled waste " Condition of personnel exposed to spilled waste " Description of cause " Corrective action and/or preventive measures EMERGENCY SPILLS: Emergency spills (as determined by the COTR), are not covered by this contract. All emergency spills will be covered by the VASDHS facility personnel or their Hazardous Waste Contractor. QUALIFICATIONS: By signing this solicitation, the offeror is certifying that he/she and any subcontractor(s) meet all requirements of Federal, State and local codes regarding operations for this type service. The offeror must provide the Contracting Officer with proof of applicable licenses and an approved pharmaceutical waste acceptance protocol. RETURN OF CONTRACTOR'S EQUIPMENT: Upon contract expiration, or earlier termination, the contractor shall arrange with the COTR a time to pick-up the equipment or provide means to have the equipment shipped back to the Contractor, at no expense to the Government. The contractor must make arrangements for the equipment to be removed from the VA within 30 days after contract expiration or cancellation. INVOICE AND PAYMENT: Payment to be made monthly in arrears upon receipt of a properly prepared invoice. Contractor shall submit invoice in the original, addressed to: Department of Veterans Affairs VA Financial Services Center P.O. Box 149971 Austin, TX 78714 (toll-free telephone number: (877) 353-9791) The invoice MUST be itemized to include the following information. Any information listed below that is not provided on an invoice, will render that invoice incomplete and the invoice will be returned for immediate correction. 1. Time period being invoiced for. 2. Description of services. 3. Unit Cost billed. 4. Extended amount due. 5. Invoice number, date, and 6. Contract and obligation number. TERM OF CONTRACT: This contract is effective for one (1) year from the date of award, subject to the availability of appropriated VA funds. The contractor shall not perform services after September 30th in any contract year without written authorization from the contracting officer. OPTION YEARS: The Government is not obligated to exercise option years contained herein. Option years will be evaluated prior to the expiration of the period in effect and, as determined to be in the best interest of the Government, may or may not be exercised (refer to FAR Clause 52.217-9, Option to Extend the Terms of the Contract) and are subject to the availability of funds. ADDITIONAL REQUIREMENTS/PUBLICATIONS: Certificate of Destruction: A "Certificate of Destruction" shall be provided after each pharmacy waste load. VA Handbook 6300.1 "VASDHS Records Management Procedure" shall be applicable to all record/microfiche destruction. The procedure reads: "The authorized destruction of records that are classified or otherwise restricted form disclosure by statute, such as PA or Title 38 USC, must be witnessed by a Federal employee or a contractor employee assigned in writing by the COTR. If a contract is used to dispose of restricted VA records The facility Records Officer must authorize the use of a contractor or subcontractor employee to witness the destruction. The contract of sale should state that the contractor employee is authorized to witness for destruction of the record. Any contract for sale of VA records must prohibit their resale for use as records or documents. Confidentiality of material destruction: Contractor personnel shall comply with the confidentiality in the destruction of all VASDHS (VISN Station-664) records. Any contractor personnel found to be reading or mishandling any of the VA materials shall be promptly removed from the government premises. The person/s involved shall not be allowed to return to the VA premises for any future requests. Restrictions: The VA Hospital is a government facility. Loading dock hours are limited, so contact any of the authorized personnel below for availability. Privacy and Security Standards: The Contractor must abide by the VHA Privacy and Security Standards as per the VHA Handbook 1605.1 & 6500. The Contractor is aware of the requirements of 38 CFR § 7332 and agrees to abide by them: Any individually-identifiable information related to VHA treatment of drug abuse, alcoholism, sickle cell anemia, and testing or treatment for HIV has special protection under 38 U.S.C. Section 7332. The information can only be disclosed as authorized by 38 U.S.C. 7332, and the implementing VA regulations at 38 CFR 1.460 -1.496. [VHA HBK 1605.1] The Contractor is aware of the requirements of 38 CFR § 5701 and agrees to abide by them: The VA Claims Confidentiality Statute, 38 U.S.C. 5701, implemented by 38 CFR Section 1.500-1.527. This statute provides for the confidentiality of all VA patient and claimant names and home addresses (and the names and home addresses of their dependents) and permits disclosure of the information only when specifically authorized by the statute. Title 38 CFR Sections 1.500-1.527, are not to be used in releasing information from patient medical records when in conflict with 38 CFR 1.575-1.584, 38 CFR 1.460-1.496, or 45 CFR Parts 160 and 164. [VHA HBK 1605.1] The Contractor is aware of the requirements of 38 CFR § 5705 and agrees to abide by them: (6) Confidentiality of Healthcare Quality Assurance Review Records, 38 U.S.C. 5705, implemented by 38 CFR Section 17.500-17.511. This statute provides that records and documents created by VHA as part of a designated medical quality-assurance program are confidential and privileged and may not be disclosed to any person or entity except when specifically authorized by statute. [VHA HBK 1605.1] The Contractor is aware of the requirements of HIPAA and agrees to abide by them: HIPAA (Public Law (Pub. L.) 104-191) implemented by 45 CFR Parts 160 and 164. This statute provides for the improvement of the efficiency and effectiveness of health care systems by encouraging the development of health information systems tough the establishment of standards and requirements for the electronic transmission, privacy, and security of certain health information. VHA must comply with the Privacy rules when using, maintaining, creating, and disclosing individually-identifiable health information. [VHA HBK 1605.1] The Contractor is aware of the requirements of the Privacy Act and agrees to abide by them: The Privacy Act, 5 U.S.C. 552a, implemented by 38 CFR Section 1.575-1.584. Generally, the Privacy Act provides for the confidentiality of individually identified and retrieved information about living individuals that is maintained in a Privacy Act system of records and permits disclosure of Privacy Act-protected records only when specifically authorized by the statute. The Privacy Act provides that the collection of information about individuals is limited to that which is legally-authorized, relevant, and necessary. All information must be maintained in a manner that precludes unwarranted intrusion upon individual privacy. Information is collected directly from the subject individual to the extent possible. At the time information is collected, the individual must be informed of the authority for collecting the information, whether providing the information is mandatory or voluntary, the purposes for which the information will be used, and the consequences of not providing the information. The Privacy Act requires VHA to take reasonable steps to ensure that its Privacy Act-protected records are accurate, timely, complete, and relevant. [VHA HBK 1605.1] The Contractor is aware of the Green program and is willing to abide with the Executive Order: Green Environmental Management System (GEMS Recycling), and the Executive Order 13423 (Recycling Program). SECURITY/BACKGROUND INVESTIGATION: Failure of a Contractor whose personnel or Subcontractor personnel have access to patient information and/or VA information systems to comply with the contractor personnel security requirements detailed in the "CONTRACTOR PERSONNEL SECURITY REQUIREMENTS" may result in termination of the contract for default. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS 1. Position Sensitivity and Background Investigation - The position sensitivity and the level of background investigation commensurate with the required level of access is: 1 Low/NACI Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries (current cost: $231). Position Sensitivity Background Investigation (in accordance with 7010 Handbook Appendix A) Low National Agency Check with Written Inquiries (NACI) A NACI is conducted by OPM and covers a 5-year period. It consists of a review of records contained in the OPM Security Investigations Index (SII) and the DOD Defense Central Investigations Index (DCII), FBI name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment. In VA it is used for Non-sensitive or Low Risk positions. 2. Contractor Responsibilities a. The contractor is encouraged to have all contractor personnel performing services in positions identified within this purchase order as requiring personal investigation to immediately download the background investigation packet from the website designated below upon notification of purchase order award. b. It is imperative for the contractor to provide to the Contracting Officer, within two business days following notification of purchase order award, a listing of all contractor personnel performing services in positions identified within this purchase order as requiring personal investigation for the process to commence. Contractor employee security check input roster spreadsheet shall be submitted upon award and shall reflect the following information: Employee position/title Employee name (last, first, middle (if none indicate "NMN")) Social security number Date of birth City, state, and country of birth Email address Additionally, an email address for the Contractor's primary point of contact must be included on the forwarding document for the list of employees. c. The contractor shall ensure that all employees identified in the listing submit a complete background investigation packet. Additional guidance and information in completing the required forms, as well as forms for packet submission can be found at: http://www1.va.gov/VABACKGROUND_INVESTIGATIONS/index.asp d. The Contractor shall ensure that all personnel listed on the Attachment submit fingerprints as fingerprinting is required with the background investigation. Fingerprinting can be done at the nearest VA Facility; however, submission of fingerprints at a VA Facility other than that identified as the contract performance location may result in unnecessary delays in start of work. The Electronic Fingerprint Verification Form must be submitted with the above required forms. e. The Contractor shall inform the contract employee that when filling out Standard Form 85, that there should be no gaps in employment history. Any gaps in employment history on Standard Form 85 may result in OPM rejecting the documentation for investigation and delay contract performance. f. The Contractor shall ensure that completed employee background paperwork is submitted to the following address within ten (10) business days from date of notification of award to the following address: VA Security Investigations Center 2200 Fort Roots Drive, Bldg. 192/Contractor North Little Rock, AR 72114 g. When notified that complete and acceptable investigation packets have been received at SIC, the Contractor shall be prepared for employees to commence work on the date and time established by the Contracting Officer at the time of such notification. If the purchase order involves on-station work, Contractor employees shall report to the office designated in the Contracting Officer's notification of purchase order effective date for issuance of VA Identification Cards. h. When notified of an unfavorable determination subsequent to investigation by the Government, the Contractor shall withdraw the employee from performing work under this purchase order, and at the request of the VA, submit another employee for consideration. i. All Contractor employees and subcontractors are required to complete VA's Privacy training annually. All Contractor employees and subcontractors requiring access to VA computer network are required to complete Cyber Security training courses annually either on-line or hard copy. Documented proof must be provided to the Contracting Officer. GENERAL PRIVACY TRAINING "VA General Privacy" training course is available on-line at the Veteran's Health Administration's (VHA) Employee Education System (EES) website: https://www.ees-learning.net/ . The basic course is designed to be finished in 50-60 minutes. If you choose to read information behind the MORE buttons, self-test questions, and scenarios, it may take you about 30 more minutes to finish. When the course is successfully completed, a training certificate will be issued on-line. Submittal: Training completion certificates or proof of training for contractor furnished training for all applicable contractor and subcontractor employees shall be forwarded as one submittal package to the Contracting Officer within ten (10) calendar days of Contract or Purchase Order award. CYBER SECURITY TRAINING "VA Cyber Security Awareness" training course is available on-line at the Veteran's Health Administration's (VHA) Employee Education System (EES) website: https://www.ees-learning.net/ . The course is designed to take approximately 1 hour. When the course is successfully completed, a training certificate will be issued on-line. Submittal: Training completion certificates for all applicable contractor and subcontractor employees shall be forwarded as one submittal package to the Contracting Officer within ten (10) calendar days of Contract or Purchase Order award. j. The Contractor will notify the Contracting Officer's Technical Representative (COTR), who will, in turn, notify the Contracting Officer, immediately when their employee(s) no longer require access to VA computer systems. 4. Government Responsibilities a. The Contracting Officer shall submit requests for contractor employee background investigations tough the VA's Office of Security and Law Enforcement. b. The Office of Security and Law Enforcement will notify the contractor with instructions for the contractor's employees, coordinate the background investigations, and notify the contracting officer and contractor of the results of the investigations. c. The VA facility will pay for requested investigations in advance. A bill for collection will be sent to the contractor to reimburse the VA facility. The Contractor will reimburse the VA facility within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the Contractors 1st month's invoice(s) for services rendered. The following provisions and or clauses apply to this acquisition. Offerors must comply with all instruction contained in FAR 52.212-1, Instructions to Offerors-Commercial. FAR 52.212-2 Evaluation-Commercial Items, paragraph (a) to this provision is completed as follows: The Government will award a contract 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. The following factors shall be used to evaluate offers: Technical and past performance, when combined, are significantly more important than price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Government will award a contract 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. The following factors shall be used to evaluate offers: Technical - Understanding of the Problem, Feasibility of Approach, and Completeness Past Performance Price Technical and past performance, when combined, are significantly more important than price. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The following factors shall be used to evaluate offers: 1. TECHNICAL: Offeror is required to submit with their offer: (A) A copy of any and all permits that are needed for regulatory compliance. (B) Evidence showing that all personnel proposed to work on this contract have received training in hauling and/or handling pharmaceutical waste. 2. PAST PERFORMANCE: This factor will indicate, for each offeror, successful performance and ability to fulfill the requirements of the solicitation. In the case of an offeror without a record of relevant past performance or for whom information past performance is not available, the offeror may not be evaluated favorably or unfavorably on past performance. To assist in this determination, offerors are required to furnish the following information: (A) Provide the number of years that the offeror's company has been in business providing the type of services requested in this solicitation. _____________ (yrs.) (B) Provide a minimum of tee (3) previous contracts under which you have provided the same service as called for in this solicitation. Required information must include but not be limited to: #1 Contract Dates & Dollar Value __________________________________ Customer Name______________________________________________ Address_____________________________________________________ Contact Name________________________________________________ Contact Phone Number_________________________________________ Contact Fax Number___________________________________________ Contact E-Mail Address________________________________________ List of Services_______________________________________________ _______________________________________________ _______________________________________________ #2 Contract Dates & Dollar Value __________________________________ Customer Name______________________________________________ Address_____________________________________________________ Contact Name________________________________________________ Contact Phone Number_________________________________________ Contact Fax Number___________________________________________ Contact E-Mail Address________________________________________ List of Services_______________________________________________ _______________________________________________ _______________________________________________ #3 Contract Dates & Dollar Value __________________________________ Customer Name______________________________________________ Address_____________________________________________________ Contact Name________________________________________________ Contact Phone Number_________________________________________ Contact Fax Number___________________________________________ Contact E-Mail Address________________________________________ List of Services_______________________________________________ _______________________________________________ _______________________________________________ (C) Provide evidence of any past adverse actions by state, local or federal regulatory agencies (such as citations, notice of violations, etc.). 3. PRICE: The cost/price stated in the Schedule of Supplies and or Services is to be inclusive of all required services for the base year and the option years. Award will be made to the responsible offeror(s) whose proposal conforming to the solicitation is determined most advantageous to the Government, cost and other factors considered. Therefore, the offeror with the lowest cost or price alone may not necessarily be awarded the contract. All offers will be evaluated using tee factors in accordance with their relative value as defined above. In descending order of importance, these factors are: Technical, Past Performance and Price. Evaluation Procedure: 1. The Technical Evaluators will assess and rate proposals based on how well the offerors meet the requirements outlined in the Solicitation using the evaluation criteria and instructions in this Plan. Evaluators will assess each proposal, and past performance information, then prepare a narrative description of the strengths, weaknesses, and areas requiring clarification to support the proposal's rating. Evaluators shall evaluate each proposal against the stated evaluation criteria and ensure that proposals are not compared against one another. 2. Rating Definitions: A. The rating for the Technical Factor will be expressed as an adjectival assessment of Outstanding, Good, Acceptable, Susceptible to Being Made Acceptable or Unacceptable. The following rating definitions will be utilized in the evaluation of the Technical Factor: Outstanding - A proposal that meets or exceeds all of the Government's requirements, contains extensive detail, demonstrates a thorough understanding of the problems and is highly feasible (low risk). Good - A proposal that meets or exceeds all of the Government's requirements, contains at least adequate detail, demonstrates at least an understanding of the problems and is at least feasible (low to moderate risk). Acceptable - A proposal that at least meets all of the Government's requirements, contains at least minimal detail, demonstrates at least a minimal understanding of the problems, and is at least minimally feasible (moderate to high risk). Susceptible to Being Made Acceptable - An approach which, as initially proposed, cannot be rated acceptable because of minor errors, omissions or deficiencies which are capable of being corrected without a major rewrite or revision of the proposal. Unacceptable - A proposal that contains a major error(s), omission(s) or deficiency (ies) that indicates a lack of understanding of the problems or an approach that cannot be expected to meet requirements or involves a very high risk; and none of these conditions can be corrected without a major rewrite or revision of the proposal. Deficiency is defined as a material failure of a proposal to meet a Government requirement or a combination of significant weaknesses in a proposal that increases the risk of unsuccessful contract performance to an unacceptable level. Strength is defined as any aspect of a proposal when judged against a stated evaluation criterion, enhances the merit of the proposal or increases the probability of successful performance of the contract. A significant strength appreciably enhances the merit of a proposal or appreciably increases the probability of successful contract performance. Weakness is defined as a flaw in the proposal that increases the risk of unsuccessful contract performance. A significant weakness in a proposal is a flaw that appreciably increases the risk of unsuccessful contract performance. B. The rating for the Past Performance Factor will be expressed as an adjectival assessment of High Risk, Moderate Risk, Low Risk or Unknown Risk (as defined below). High Risk - Significant doubt exists, based on the Offeror's performance record, that the Offeror can perform the proposed effort. Moderate Risk - Some doubt exists, based on the Offeror's performance record, that the Offeror can perform the proposed effort. Low Risk - Little doubt exists, based on the Offeror's performance record, that the Offeror can perform the proposed effort. Unknown Risk - No relevant performance record identifiable; equates to a neutral rating having no positive or negative evaluation significance. FAR 52.212-3, Offeror Representation and Certification-Commercial Items, a completed copy of this provision shall be submitted with the offer. Quotes without this provision will not be considered for an award. FAR 52.212-4, Contract Terms and Conditions-Commercial Items; FAR 52.212-5, Contract Terms and Condition Required to Implement Statues or Executive Orders-Commercial Items (Jul 2010) include clauses (b)(4),(18), (19), (20), (22), (23), (24), (25), (26), (27), (40), and (c)(1),(2), and FAR 52.216-18 ORDERING (OCT 1995) , 52.216-19 ORDER LIMITATIONS (OCT 1995), 52.216-22 INDEFINITE QUANTITY (OCT 1995), 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999), 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984), VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984), VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008), VAAR 852.203-71 DISPLAY OF DEPARTMENT OF VETERAN AFFAIRS HOTLINE POSTER (DEC 1992), VAAR 852.216-70 ESTIMATED QUANTITIES (APR 1984) , FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998), REQUIRED INSURANCE, VAAR 852.273-76 ELECTRONIC INVOICE SUBMISSION (Interim - October 2008), VAAR852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (DEC 2009), VAAR852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009), 52.216-1 TYPE OF CONTRACT (APR 1984), 52.216-1 TYPE OF CONTRACT (APR 1984), 52.233-2 SERVICE OF PROTEST (SEP 2006), VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (JAN 2008), and VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998), 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998). The following clauses may be accessed electronically in full text tough http://www.acquisition.gov/far/index.html and http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm ELECTRONIC TRANSMISSION IS PREFERRED. Quotes must be transmitted by e-mail to amanda.bartman@va.gov or FAX to (562) 961-1373 and are to be received at no later than 9/22/2010 3:00 PM PST. The point of contact for this solicitation is Amanda Bartman, Contract Specialist. Department of Veterans Affairs, VISN 22 Network Contracting Activity ,5901 E. 7th Street, Long Beach, CA 90822. In order to maintain integrity of this solicitation and subsequent award date, all offerors are advised that any questions must be submitted in written form via e-mail to amanda.bartman @va.gov or via fax to (562) 961-1373 to the Contracting Officer and shall be received no later than two (2) workdays before Offerors Due Date 9/22/2010 3:00 PM PST. Additional contract requirements: The Contractor will have to complete a standard Business Associate Agreement (BAA) in accordance with the Health Insurance Portability and Accountability Act of 1996. The BAA will be supplied to the Contactor from the VASDHS after the contract is awarded. Also, CONTRACTOR EMPLOYEE SECURITY CHECK INPUT ROSTER spreadsheet will be supplied to the Contractor after the contract is awarded. The offeror should thoroughly review the solicitation and become familiar with the areas of coverage prior to submitting an offer, in order to be fully aware of the services required. Failure to understand the contract's requirements will not relieve the contractor from performing in accordance with the strict meaning and intent of the specifications. This is an all-inclusive contract and the Government will not reimburse any costs not incorporated into the resultant contract. OFFERORS ARE NOTIFIED that failure to provide any of the information requested may result in an offer being considered non-responsive. CAUTION - LATE Submissions, Modifications, and Withdrawals: See provision 52.212-1. All offers are subject to all terms and conditions of this solicitation. CENTRAL CONTRACTOR REGISTRATION (CCR): pursuant to FAR Clause 52.212-4, para (t), Central Contractor Registration (CCR), after initial registration, the Contractor is required to update registration data as changes occur and must re-register annually to ensure all data remains current. Noncompliance with this requirement will preclude the exercising of any option periods that may be included herein and will be cause for termination of the contract at such time noncompliance is discovered. Refer to cited Clause for more details. The CCR website is http://www.ccr.gov. VENDOR INFORMATION PAGES (VIP): All Service-Disabled Veteran Owned Small Businesses and Veteran Owned Small Businesses must be registered in the, Vendor Information pages (VIP) database, to be eligible for contract award. You are required to register with "The Center for Veterans Enterprise", Vendor Information Pages database at the following web address: VIP http://www.vetbiz.gov. DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided below: DUNS#_____ _____ _____ _____ _____ _____ _____ _____ _____ VA26210RQ0519 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22
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