ATTACHMENT 1 PERFORMANCE WORK STATEMENT DISPOSAL OF REGULATED MEDICAL WASTE 1. Scope: The contractor shall furnish all equipment, labor, materials, labels, containers, tools, transportation, movement documents in accordance with the movement regulation (ADR, European Agreement concerning the International Carriage of Dangers Goods by Road (ADR) or The International Maritime Dangerous Goods Code (IMDG), as appropriate), quality control and supervision for performing all operations for the collection, transportation, sterilization and incineration of regulated medical wastes, from 65 th Medical Group. The contractor service will be based on the identification documents, i.e. USAFE Form 1930, provided by the waste generator. 2. Performance: Healthcare waste shall be handled, treated, destroyed, packaged, labeled, and disposed of as further specified in this Performance Work Statement (PWS) and the regulations listed below as the basis. If there is a conflict between these standards, the most stringent classification will be followed. [Basis: EEC 75/442, Council Directive on Waste; EEC 91/689 Council Directive on Hazardous Waste; 2000/532/EC council directive on waste and establishing the waste list; EC 1272/2008 Directive on classification, labeling and packaging of substances and mixtures amending and repealing Directive 67/548 and 1999/45/EC and amending EC 1907/2006; EC 2008/68 Directive on the inland transportation of dangerous goods; The following agreements: ADR and IMDG (as applicable); and the country specific implementation thereof; “Decreto –Lei 239/97, 9 Setembro 97”; “Portaria 178/97, 11 Março”; “Portaria 174/97, 10 Março”; “Portaria Regional 35/97, de 30 Maio de 97; “Resolução no. 65/2003 de 5 de Junho”; “Decreto Lei 73/2011 de 17 Junho”; “Decreto Lei 178/2006, de 5 Setembro”; and the local Azores government laws “Decreto Legislativo Regional 10/2008/A de 12 de Maio”; “Portaria no. 74/2009 de 14 Setembro de 2009”, “Declaração de Rectificação no. 11/2009 de 2 de Outubro de 2009”; “Portaria no. 12/2010 de 2 Fevereiro de 2010”, “Decreto Legislativo Regional no. 10/2008/A” and chapter 8, Medical Waste Management of Final Government Standards – Portugal (FGS-P) February 2011, (updated January 2014); the most stringent classification criteria applies] 3. Contractor Responsibilities: 3.1. CLINICAL Waste (CW) identification list: EWC Description Applies1) Y/N 180101 sharps (except 18 01 03) N 180102 body parts and organs including blood bags and blood preserves (except 18 01 03), skin, hair, organs, meet, bones, water, salts N 180103* wastes whose collection and disposal is subject to special requirements in order to prevent infection Y 180104 wastes whose collection and disposal is not subject to special requirements in order to prevent infection (for example dressings, plaster casts, linen, disposable clothing, diapers) N ATTACHMENT 1 180106* chemicals consisting of or containing dangerous substances; i.e. uncleaned packages, materials used in conjunction with patient treatment or cleaning of patient care areas with a possible mix with infectious materials, i.e. solvents, organic or inorganic chemicals, uncleaned packaging material, contaminated metals, glass, paper or cardboard, etc. N 180107 chemicals other than those mentioned in 18 01 06 N 180108* cytotoxic and cytostatic medicines N 180109 medicines other than those mentioned in 18 01 08 N 180110* amalgam waste from dental care N Note for the waste generator: Enter Y if this waste stream applies. The specifics are listed in Attachment A. Enter “N” if this waste does not apply. 3.2. Container and Packages IAW packing rules: The contractor shall supply packaging conforming to the packing rules identified in the hazardous waste profile sheet has shown in Attachment A. Packages can be normal, large, intermediate bulk containers or large containers, as applicable and as appropriate. Non-conforming packages will be refused by the waste generator at no cost to the Government. All the full containers will be removed from the storage and a new empty container will be left on its place. The size of packages shall be suitable to the volume of clinical waste and the frequency of pick up. The contractor is responsible to ensure all packages are properly sealed prior to loading them. 3.2.1. Sharps/Needles Containers: Sharps/needles containers will be provided by the Government. 3.3. Marking and Labeling: The contractor is responsible for properly marking and labeling of the packages conforming to the waste, ESOH (Environment, Safety and Occupational Health) and movement regulations applicable in Host Nation (HN) country. The text on the label must be in the language of the HN country and also in English. 3.4. Vehicle: Upon entry to the base, the contractor ensures all vehicle operators conform to all safety regulations for operating vehicles on military installations as identified by the Installation Commander. Off base vehicle operators must comply with requirements for vehicles moving dangerous goods as outlined by the HN traffic safety rules. Registration of vehicles must comply with vehicle registration and, if applicable, with dangerous goods vehicle certification rules. The contractor will ensure vehicle operators are properly trained and carry instructions in writing, identification documents, ADR driver training certificate, if applicable, and all movement documents listed in Chapter 8 ADR. The contractor ensures vehicles are equipped with the proper hazard placards and warning plates as described in CH 5.2 and 5.3 ADR, and where appropriate, IAW waste regulations (i.e. “A” in Germany and “R” in Italy). Equipment described in the Instructions in Writing and in Part 8 ADR must be on board the vehicle. The vehicle owner is responsible to provide the equipment in serviceable condition. If equipment is missing or nonserviceable the truck will be refused at the expense of the contractor. The vehicle operator is responsible for proper load distribution and load securing of the vehicle. The contractor is responsible to comply with the provisions regarding security plans for waste listed as high consequence dangerous goods IAW ADR 1.10. Non-compliance will result in not releasing the goods. The second pick up is at the expense of the contractor. 3.5. Container: In case of ocean movement or large volume consolidation, the contractor is responsible for properly loading and securing HW packages inside the container. The contractor ensures the container meets the ATTACHMENT 1 Container Safety Certification (CSC) requirements. Further, the contractor is responsible to placard to containers IAW the selected mode of shipment, ADR or IMDG, as appropriate. In case of sealift, stowing and segregation rules of IMDG must be complied. 3.6. Reporting: The contractor is responsible to provide reports on the proper disposal of the waste to the generator conforming to the HN rules. The contractor shall be responsible for the preparation of tracking forms IAW HN regulations. Tracking forms should indicate the following as a minimum: date of pick up, name of the contractor’s worker, name of Government Representative, type of waste, amount of waste (volume or weight) picked up. Contractor will secure an authorized signature on said tracking form and carry it with the shipment of waste to its accumulation point until it will be treated or shipped for treatment/incineration. Additionally the contractor will provide a document that includes date of disposition, the type of waste and the type of treatment or incineration. 3.7. Point of collection: The Accumulation point will be located in T-416. Prior to the waste pick-up the authorized caller, will communicate the type and amount of waste requiring pick up. 3.8. Schedule and Procedures: The contractor will respond to requests originated by the Government. The procedures shall govern the methods of collection, type of container, method of transportation and placement of empty receptacle for exchange with the filled receptacles. 3.9. Execution of Work: The contractor shall accomplish all work conformant to all applicable safety and security rules applicable to the loading, movement, unloading and disposal of clinical waste. 3.10. Hours of Operation: The contractor shall pick up clinical waste as soon as possible after the notification ensuring it is in compliance with FGS-P that requires that medical waste should be removed within 72 hours or in a week if refrigerated. Work must be scheduled within normal duty hours of Government employees. 3.11. Accidents/Incidents: If the truck removing the hazardous clinical waste has an accident or is causing an incident as described in ADR 1.8.5, the contractor will inform the Government POC. 4. Waste Generator Responsibilities: 4.1. Identification of waste: The waste generator is responsible to identify the waste IAW waste, ESOH and movement regulations using a hazardous waste profile sheet. (USAFE Form 1930 is recommended). 4.2. Government POC: The waste generator will provide the point of contact to the contractor who is authorized to place calls on behalf of the contracting officer for the waste pick up. The government POC will be a person qualified in Medical Waste Classification. The government POC will ensure only Hazardous Waste/Clinical Waste (HW/CW) is handed over for transport which conforms to Department of Defense (DOD), United States European Command (EUCOM), and United States Air Force in Europe (USAFE) instructions regarding preparation, movement, and implementation of European agreements and regulations applicable to HW for US Forces. The government POC ensures the placement of pick up is by traceable means, in writing or electronically, conforming to the format of the movement regulation. Further the government POC ensures the report of the waste disposal is maintained on file IAW HN country rule for review by HN authorities upon request. 4.3. Waste collection points: The waste materials will be filled by personnel assigned to the waste generator into contractor supplied containers IAW the CW identification described on the HW profile sheet. The following location is the accumulation point where the waste can be picked up from: BLDG # T-416, Clinic LOCATION Storage Room 1 ATTACHMENT 1 4.4. Attachments: Attachment A, Clinical Waste Data Listing (End of Document)