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2 PERFORMANCE WORK STATEMENT (PWS) Illinois CMOP Conveyor System Integration of a Rotary Capper BACKGROUND & INTRODUCTION The Great Lakes Consolidated Mail Out-Patient Pharmacy (GL-CMOP) located at 5t... 2 PERFORMANCE WORK STATEMENT (PWS) Illinois CMOP Conveyor System Integration of a Rotary Capper BACKGROUND & INTRODUCTION The Great Lakes Consolidated Mail Out-Patient Pharmacy (GL-CMOP) located at 5th and Roosevelt Building 37 NW, Hines, IL 60141 and is a provider of outpatient pharmaceutical services dispensing approximately 100,000 prescriptions daily direct to patients by mail. The Pharmacy operates across two (2) shifts from 5 am to Midnight (12 am) with a staff compliment of approximately 300 people. Period of Performance: Conveyor Installation and Integration of One TeDelta Rotary Capping Machine (CAR-103-TR) TBD by best delivery date OBJECTIVE and SCOPE OF WORK The purpose of this contract is to connect and integrate one TeDelta CAR-103-TR-PZ rotary capping machine into the Baker s (Tablet Counting Automation TCA) conveyor belt system This integration needs to be capable of inspecting all capped pharmaceutical bottles and must reject incorrectly capped bottles, and to control and communicate with photo eyes, holdbacks, and diverts. The integrated conveyor footprint (includes the TeDelta capper in the footprint) needs to be within a 5 (width) x 13 10 (length) footprint on the floor plan. The contractor must provide project management regarding this scope of work. The Contractor s representative must schedule all work with the Contracting Officer s Representative (COR). The COR is designated at the time of award. If on-site work is necessary, then all contract personnel must present a government issued picture ID and sign in to receive a Contractor identification access badge before any work is performed under VA escort. All contractor s will be escorted by a Veteran s Affairs employee while on the GL-CMOP premises. Additionally, the contractor must perform all work according to federal, state, municipal, local guidelines, and ordinances with evidential supporting documentation. All safety practices prescribed by these agencies must be followed and must additionally mitigate any risk to employee and patient safety. PERFORMANCE REQUIREMENTS - Contractor requirements are as follows: 3.1 Connect the TeDelta capper system to a single belt conveyance system that is 100mm in width that must be no lower than 37 and no higher than 42 ¾ . The contractor must be able to add sections of new conveyor as needed for a seamless interface with fit and finish to the existing belt system without dumping pharmaceutical pucks; however, the distance between the existing perpendicular incoming conveyor feed to the perpendicular exit conveyor feed must not exceed 13 10 (166 ). The newly integrated conveyor system must be able to variably synchronize with the main line SpanTech conveyor speed and the capping machine s speed. 3.1.1 The new conveyor adjustments must not interfere with the current conveyor belt operations to achieve a capping rate of 2,000 bottles per hour or greater. 3.1.1.1 The existing and incoming conveyor line that is perpendicular to the input side of the capper must not be greater in distance from the outgoing or egress side that is perpendicular to the capper s exit by no more than 13 10 (166 ). 3.1.1.2 The reject lane must be positioned perpendicular from the exit side of the capper and no more than 14 from the perpendicular exit conveyor feed. 3.1.1.3 The conveyor belt must consist of a modular construction with hinged links connected by rods and the belt type must be approved by the COR before installation. 3.1.1.4 The conveyor belt drive sprockets and the belt drive system must be approved by the COR before installation. 3.2.2 Integration must include a divert or rejection lane (after bottles are capped) to channel bottles that are incorrectly capped (either no cap or an incorrectly seated cap on the bottle). Outgoing bottles must divert correctly under control of the conveyor system and synchronized with the conveyor s speed, which may be independent of the capper speed. Correctly capped bottles proceed onto the existing conveyor to the station that removes the bottles from the pucks, and incorrectly capped bottles divert off the main conveyor to have corrections made to the bottles (in proximity of the current reject line). 3.2.3 Integration of safety electronic stops (E-Stops). 3.2.4 Integrate a warning light system to indicate a halt with capping operations. 3.2.5 Integrate a green light system indicating capping operations are proceeding correctly. 3.2.6 Integrate using both existing and new conveyor hardware (includes 19 8.22 of the new conveyor system from TeDelta) as needed. 3.2.7 Software integration must be capable of producing electronic notifications as follows: 3.2.7.1 Jams with cap elevator and waterfall. 3.2.7.2 Jams with TeDelta capper. 3.2.7.3 Belt stoppage, stopped production. 3.2.7.4 Unique alarm software communication error notifications. 3.2.7.5 Integration of photo eyes, holdbacks, and diverts. 3.2.8 Integration must work with pucks (diameter of 3.76 ) that use RFID technology and be capable of handling 120cc and 250cc bottles to, through, and coming out of the capper. 3.3 Connect the capper system to single phase, 208V, 60Hz power meeting all local electrical codes. 3.4 Integration of the TeDelta capper system must be done in a manner to allow access into all doors and panels of the capper for all aspects of maintenance and service and system adjustments. 3.5 All integration work will not interfere with manual capping, which must continue with production as determined by the CMOP COR while the capper is being installed and integrated into the Baker system s conveyor system. 3.5.1 The cap elevator and bridge must be integrated to fit within the floor footprint of 5 (width) x 13 10 (length) x 12 (height). 3.5.2 The cap elevator must be positioned in a manner that will not interfere with the Baker system s existing conveyor system, and will not interfere with manual capping, which must be done while capping machine is being integrated into the existing and new conveyor system. 3.6 Contractor conducts a strategy to stage and set up as much of the new conveyor integration components as possible prior to arrival of the TeDelta capper (if it has not arrived) with coordination assistance from the GL CMOP s engineering and maintenance staff. Contractor includes a project kick-off meeting at the start of the Period of Performance (PoP) with the time and location as determined by the Contracting Officer, which does not interfere with current CMOP production operations. Provide engineering and configuration support for all systems, subsystems, assemblies, and components. Provide all testing plans to the COR for approval before testing begins. Provide integration testing and on-site implementation. Provide on-site, stand-by, and support services (including technical) during installation, testing, and through final acceptance testing. Provide on-site operation, safety, and maintenance training addressing the structure, function, and operation of all integrated components as well as the interaction between components and all matters regarding safety. Provide an industry standard warranty on all parts (including electrical and electronic parts) of the conveyor belt system integrating the capping system into the Baker s existing conveyor system. Final Testing and Acceptance Requirements are as follows: Meet or exceed all requirements and performance standards outlined in this PWS. The new conveyor system integrating the capping machine into the Baker s conveyor system must meet these performance benchmarks as follows: Must be capable of handling a capping rate of no less than 2,000 bottles per hour. Conveyor belt operations must handle all pharmaceutical pucks without dumping any contents from the pharmaceutical bottles. Provide user technical support solutions with an on-site team regarding the new and integrated conveyor system. GOVERNMENT PROVIDED DELIVERABLES The Government must provide these conditions as follows: equipment, access, and facilities for the Contractor to complete all the performance requirements to the performance standards in this PWS. Ensure sufficient floor space exists to integrate the TeDelta capper into the Baker s existing conveyor system. Provide sufficient access to the facility as required to perform the on-site work. Provide staff support for the technicians performing the work on-site. Escorted access to the GL-CMOP during hours of operation. COR approval is needed for access outside of normal GL-CMOP operating hours. Security for the installation areas provided by qualified security personnel. Provide clean, lighted, and safe working areas. Broom cleaned installation areas. Safety fences and tape. Waste bins. PERFORMANCE STANDARDS Contractor must set-up, assemble, integrate, start-up, and test all mechanical, electrical, and computer related communication software, and conveyor components. Functional testing is according to the agreed scope (general specifications) with component and system performance testing. The contractor maintains a quality control program ensuring all design, deliverance, transport, installation, integration, testing, software integration, and commissioning are performed in accordance with these specifications throughout the entire contract period. The contractor must implement procedures to track, identify, prevent, remedy, analyze, and ensure non-recurrence of defective equipment, parts, work, or services are provided. Additionally, the contractor must provide a method to accept and resolve customer complaints and to notify the customer of the resolution and must immediately notify the Contracting Officer upon receipt of a customer complaint so joint validation can be accomplished. The contractor is responsible for quality control and specification compliance. Proper adherence to all safety procedures is required prior, during, and after performed work. When on-site work is required, then the contractor must furnish all personnel with any required personal protective equipment (PPE). The contractor must safeguard the public and government personnel, property, materials, supplies, and equipment exposed to the contractor s operations and activities, and avoid interruptions of government operations in the performance of work. 6.1 Documenting Performance Acceptable Performance: The Government must document positive performance. Any report may become a part of the supporting documentation for acceptance leading to fixed fee payments, award fee payments, or other actions. 6.2 Defining Defects Criteria with Unacceptable Performance Critical Defect: Critical defects are the most severe type of errors with the greatest potential for customer harm for infectious treatment and/or regulatory action. Examples include area not cleaned; work safety violations; contamination of pharmaceutical products; spillage of pharmaceuticals, non-compliance with frequencies of work schedules; damage to government equipment, or gross negligence of VA or GL-CMOP procedures. 6.2.1 Critical defects result in an immediate written warning and, depending upon the severity, and may result with additional disciplinary action up to and including termination. 6.2.2 Significant Defect: Major defects resulting from failure to follow applicable GL-CMOP procedures; not meeting performance requirements in this PWS; failure to meet final factory acceptance testing; failure to adhere to Veterans Affairs Information technology regulations, procedures, or guidelines and, if left uncorrected would have the potential to become a critical defect or result in customer dissatisfaction. 6.2.3 Significant Defects result in: 1st occurrence GL-CMOP Policy Review and Coaching Opportunity (Verbal Warning). 2nd occurrence - GL-CMOP Policy Review and Written Warning to Contractor with formal communication from the Contracting Officer. Note: Examples of defined defects noted above are not all inclusive. Specific defects outside of the defined defects examples will be examined on a case-by-case basis. 7.0 Quality Control Program (QCP) The Contractor must establish a complete QCP ensuring the requirements of the contract are provided and met as specified. Upon award, the Contractor must submit a type-written plan meeting PWS requirements for this program to the COR with a Cc to CO for approval. The QCP must be a system for identifying and correcting deficiencies in the quality of services provided before the level of performance becomes unacceptable and/or before the Government inspectors point out deficiencies. This QCP is centrally important. The program must include, but is not limited to the following: An inspection system, that will affirm installed equipment is correctly installed and functioning meeting the requirements of this PWS. The Contractor and the Contractor's employees who monitor service availability and quality of work must not be the same person who monitors compliance with the QCP. A system ensuring deficiencies do not reoccur based upon customer support rendered from the contractor. Documentation of customer support correcting deficiencies must be made available to the Government during the terms of the contract and to the COR upon request. 8.0 DELIVERABLES 8.1 Planning design layouts and pre-production layouts with a detailed implementation schedule are due at the time the contract is awarded. 8.2 Within 30 business days after contract award and prior to the integration of the TeDelta capper at the GL CMOP, the contractor must provide a detailed engineering construction drawing of the integration for COR approval. 8.3 Contractor must provide a list of names of those who will be working on-site to facilitate temporary security pass approval a minimum of 2 weeks prior to on-site work and repairs. After integration and before final acceptance testing the contractor is required to deliver a report listing the equipment and components installed, inspected, condition of systems inspected, recommendations for repairs, maintenance, or integration. LIABILITY OF DAMAGES The contractor must be liable for all damages to government equipment and property when such damage is due to fault or negligence of the contractor. The contractor must be responsible for all damages or injury to persons that occur because of the contractor s fault or negligence. The contractor must take proper safety and health precautions to protect the work, the workers, the public, and the property of others. QUALIFICATIONS Contractor must provide personnel who have the knowledge, working experience, certifications, and qualifications to perform the functions outlined in this PWS. CONTINUITY OF FACILITIES OPERATION 11.1 Identification All contract personnel must present a government picture-ID and sign in to receive a Contractor identification badge before any on-site work performed detailing the work performed and must return to the same location to sign out and turn-in the same badge along with a documented service report for services performed. The badge must be always worn in a visible location on the worker while on the premises of VA property. 11.2 Smoking Policy Vendor is advised that the Government has placed restrictions on the smoking and use of tobacco products in Government facilities. Vendor s employees and visitors are subject to the same restrictions as Government personnel. Smoking is permitted only in designated smoking areas. 11.3 Safety Requirements The vendor shall comply with all local, state, federal laws, and safety regulations. Compliance with OSHA and other applicable laws and regulations for the protection of contractor s employees (exclusively the contractor s obligation), and the Government assumes no liability or responsibility for the contractor s compliance or non-compliance with such responsibilities. The contractor must provide its employees with all necessary personal protective clothing and equipment (PPE). The Contracting Officer or his/her designee will notify the contractor of any noncompliance with the foregoing provisions and action to be taken. After receipt of such notice, the contractor must immediately correct the conditions to which attention has been directed. Such notice, when served to the contractor or his representative at the site of the work must be deemed sufficient for the aforementioned purpose. If the contractor fails or refuses to comply promptly, then the Contracting Officer may issue an order stopping all or any apart of the work and hold the contractor in default as provisioned elsewhere in this contract. 11.4 Laws and Ordinances Contractor must comply with all applicable laws, ordinances, and regulations (federal, state, city, municipal, or otherwise) covering operations under the contract. The GL-CMOP is a secure location. All contractors must comply with local policies, and procedures including those related to COVID-19 and flu prevention such as wearing masks. At all times contractor personnel must wear badges and be escorted while working in sensitive areas. The contractor and its employees will not have access to Patient Health Information (PHI), nor will they have the capability to access patient information during the services provided to the VA. 11.5 Weapons, Firearms, Ammunition Contractor s employees are prohibited from possessing weapons, firearms, or ammunition, upon themselves or on Government property while at GL-CMOP. 11.6 Fire Prevention and Safety Contractor s employees must comply with the Occupational Safety and Health Act (OSHA) and the Fire Prevention and Health Program. 11.7 Standards of Conduct The Contracting Officer or COR must refer to the Contractor for immediate action (including, but not limited) to removal of any contract personnel from the work site whose personal or professional conduct jeopardizes or interferes with the regular and ordinary operations of the GL-CMOP facility. Breaches of conduct include but are not limited to intoxication or debilitation resulting from drug use; theft; dereliction; negligence in performing tasks or other conduct resulting in complaints by staff or management. 11.8 Illegal Substances Illegal substance possession, use, or distribution will not be tolerated on any government installation, including the GL-CMOP. This includes prescribed medical marijuana. The contractor must ensure that contractor employees who have access do not possess, use, or distribute illegal substances. All vendors are required to adhere to all local, state, and federal laws concerning possession and/or use of illegal substances. Vendors found to be in possession of illegal substances will be barred from the installation and subject to arrest and prosecution by local and federal authorities. 11.9 Parking It is the responsibility of the Contractor to park in the appropriate designated parking areas. The VA will not validate or render reimbursement for parking violations incurred by the Contractor under any conditions. 11.10 Interference to Normal Functions The Contractor may be required to interrupt work at any time so as not to interfere with the normal function of the facilities, fire protection systems, facility personnel, and equipment. 11.11 Qualification of Offerors Quotations will be considered only from offerors who are regularly established in the business called for and who (in the judgment of the Contracting Officer) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory service, and adequately trained to perform services required in this PWS. 12.0 SECURITY The C&A requirements does not apply, and a Security Accreditation Package is not required.