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2 Performance Work Statement VAPAHCS Regulated Medical Waste Services 1. Scope of Work The Contractor shall furnish all labor, equipment, containers appropriately sanitized, containers properly labele... 2 Performance Work Statement VAPAHCS Regulated Medical Waste Services 1. Scope of Work The Contractor shall furnish all labor, equipment, containers appropriately sanitized, containers properly labeled, disinfected and labeled (except for Government-furnished Sharps needle containers), supplies, materials, transportation and supervision required to provide pick-up, transport, treatment/incineration and/or acceptable disposition of biomedical infectious waste, pathological wastes , non-hazardous pharmaceutical waste, and chemotherapy wastes for the VA Palo Alto Health Care System (VAPAHCS) located at 3801 Miranda Avenue, Palo Alto, CA 94304-1290, remote facilities and associated Community Based Outpatient Clinics (CBOC) identified in requirements attached. The contractor shall provide a certifiable weighing system to enable proper billing for tare weight waste poundage disposed, i.e., if the disposal container weighs 10 pounds and the Contractor is to dispose of 10 containers, each container shall be weighed, and container total weight (100) pounds is subtracted from the gross container weight to determine the total waste poundage to be paid. 2. Background information The VA Palo Alto Health Care System generated 285,681 lbs. of combined of all the above listed wastes during calendar year (CY) 2013. Pick up locations for waste are San Jose, Monterey, Capitola, Fremont Community Based Outpatient Clinics (CBOC). Palo Alto Division, Menlo Park Division and Livermore Division. 3. Performance period 3.1 The contractor shall pick up biomedical infectious waste per the Pickup Schedule and Locations as stated herein. 3.2 VA observed Federal Holidays are: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January President s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day 1st Monday in September Discoverers Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25 Any other day designated by the President as a national holiday. 4. Definition 4.1 MEDICAL WASTE: Contaminated dressings, tissues, gloves, masks, hair covers, etc. from isolation rooms, packed and tied in RED BAGS (red plastic leak-proof bags). 4.2 BIOLOGICAL AND PATHOLOGICAL WASTE: Human anatomical parts, waste tissue, blood, microbial cultures, stool samples, etc., packed in tied and leak-proof RED BAGS . 4.3 VETERINARY WASTE AND ANIMAL BODIES: Animal parts, carcasses, waste tissue and other veterinary waste packed in tied and leak-proof RED BAGS . 4.4 NON-HAZARDOUS PHARMACEUTICAL WASTE: Any pharmaceutical waste that is not defined as Biohazard-regulated medical waste, Controlled Substance, or RCRA hazardous waste. 4.5 CANCER CHEMOTHERAPY WASTE: Discarded items which have been contaminated by chemotherapeutic drugs or antineoplastic agents, provided that such items, including trace drugs used against malignant cells in treatment of cancerous tumors, vials and syringes, gauze and gloves, infusion bags, etc., shall be empty or contain only such trace amounts of chemotherapeutic drugs as are allowable under applicable Federal, state, county or municipal laws, regulations, and guidelines so as to be considered waste. 4.6 INFECTIOUS WASTES Laboratory wastes, including cultures of etiologic agents, which pose a substantial threat to health due to their volume and virulence. Pathologic specimens, including human or animal tissues, blood elements, excreta, and secretions which contain etiologic agents, and attendant disposable fomites. Surgical specimens, including human or animal parts and tissues removed surgically or at autopsy which contain etiologic agents, and attendant disposable fomites. Equipment, instruments, utensils, and other disposable materials which are likely to transmit etiologic agents from the room of humans, or the enclosures of animals, which have been isolated because of suspected or diagnosed communicable disease. Human dialysis waste materials including arterial lines and dialysate membranes. Carcasses of animals infected with etiologic agents which may present a substance hazard to public health if improperly managed. Any other material which, in the determination of the facility infection control staff, presents a significant danger of infection because it is contaminated with, or may reasonably be expected to be contaminated with, etiologic agents. 4.7 ETIOLOGIC AGENTS: A type of microorganism, helminth, or virus which causes, or significantly contributes to the cause of, increased morbidity or mortality of human beings. 4.8 INCINERATED INFECTIOUS WASTES: Infectious wastes that have been incinerated, steam sterilized or otherwise treated so as to be non-infectious, may be handled as noninfectious, nonhazardous, regular solid waste unless the material is defined as a hazardous waste or hazardous material according to section 66084, 66088, or 66680, title 22, C.A.C. 4.9 HAZARDOUS MATERIAL (Section 66084 title 22, CAC): Hazardous material means any substance or mixture of substance, which is toxic corrosive, flammable, an irritant, a strong sensitizer or which generates pressure through decomposition, heat or other means, if such a substance or mixture of substances may cause substantial injury, serious illness or harm to human, domestic livestock or wildlife. Hazardous material includes extremely hazardous material. 4.10 HAZARDOUS WASTE (Section 66088 title 22, CAC): Hazardous waste means any waste material or mixture of wastes which is toxic, corrosive, flammable, an irritant, a strong sensitizer or which generates pressure through decomposition, heat or other means, if such a waste or mixture of wastes may cause substantial injury, serious illness or harm to humans, domestic livestock or wildlife. Hazardous waste includes extremely hazardous waste. 4.11 LISTS OF CHEMICAL NAMES AND COMMON NAMES (Section 66680 title 22, CAC): The comprehensive lists of Chemical names and common names are kept in each Environmental Health office as reference material. 5. Contractor Specific Tasks 5.1 Biomedical Hazardous Waste 5.1.1 Contractor shall pick up biomedical hazardous waste weekly with adequate coordination and approval of the Contracting Officer Representative (COR). 5.1.2 The contractor shall provide COR with an invoice at least monthly that identifies the date(s), number of, types and sizes of all containers removed for treatment/disposal, providing the VA with the data to adequately track and manage wastes removed. 5.1.3 The contractor shall weigh the biomedical hazardous waste on a contractor provided scale prior to departure from the VA facility and record the weights for each pickup and include such weights in each weekly manifest. Contractor scales shall be calibrated and certified annually. Contractor shall provide calibration records to the COR. The size of the containers to be furnished shall be 44 gallon +/- 15% for biohazard waste. Contract shall make contact with COR upon arrival to facility and before taking weights of containers. COR will designate employee to witness weighing and verify weights. 5.2 Chemotherapy wastes 5.2.1 Contractor shall pick up chemotherapy wastes weekly, and the contractor shall provide container counts and actual weight at pickup. The size of the containers to be furnished shall be 8 gallons for biohazard waste. 5.2.2 The contractor shall weigh the chemotherapy waste on a contractor provided scale and record the weight for each container prior to removal from VA property in the presence of COR designated VA employee. 5.2.3 Invoices will include accurate weights and tracking documents to certify proper disposal. 5.2.4 Chemo wastes will be picked up in the secure caged area on the dock of Building 100. The contractor shall provide the COR with the necessary data to properly track and manage the waste (via manifests) to ultimate disposal, containing accurate container numbers, weights and certificates of disposal. 5.3 Pathological/infectious wastes 5.3.1 Contractor shall pick up Pathological/infectious wastes at on the dock of Building 100 for disposal. 5.3.2 Invoices shall include tracking documents to certify proper disposal. 5.3.3 Pathological wastes shall be picked up not to exceed 30 days and or as required. Invoices/manifests will include all tracking documents to certify proper disposal. Contractor shall coordinate pick up pathological wastes with VA. 5.4 .The Contractor shall treat and/or dispose of bio-hazardous medical waste in accordance with State and Federal (U.S. Environmental Protection Agency - EPA) guidelines, VAPAHCS infectious medical waste requirements located in the following local directives (138-36, Pollution Prevention Waste Minimization Program) , and all other Federal, State and local regulations. 5.5 Contractor shall maintain all necessary medical waste permits and licenses for the disposal of and treatment of such waste. 5.6 Contractor shall also have an assigned U.S. Environmental Protection Agency (EPA) authorization and identification number, necessary Department of Transportation permits, insurance prior to transport and/or disposal of subject waste. If contractor requires additional information, they may contact U.S. EPA regional office. Copy of all licenses shall be provided to Contracting Officer upon contract award. In addition, contractor shall supply an organization chart, listing of key personnel and competency training documentation that demonstrates staff ability to process various waste streams. 5.7 Pharmaceutical Waste Non-hazardous pharmaceutical waste will be disposed of in the BLUE and WHITE pharmaceutical waste container. Any solid or liquid pharmaceutical which is discarded or accumulated, stored, or treated prior to being discarded. Pharmaceutical waste will be removed from the health care system by approved contractors, in accordance with all applicable laws and regulations. 6. Contractor Qualifications for Transportation within the State of California / Disposal and Sanitation requirements 6.1 Contractor is required to be certified and licensed in the State of California and actively listed on the California Department of Public Health (CDPH) Medical Waste Management listing as being licensed and certified for the transportation of Hazardous Medical Waste. 6.2 Contractor shall employ the best environmentally sound methods of treating and destruction of wastes such as incineration and recycling or any other acceptable methods, in accordance with EPA and industry standards. 6.3 Disposal shall be performed in such a manner as not to create conditions detrimental to public health or to constitute a public nuisance. 6.4 The pick-up area where rental containers are placed shall be maintained in a clean, orderly, sanitary condition. Particular attention shall be paid to the prompt cleanup of oil and/or grease spills, either generated from the vehicles used to haul containers or because of container leakage. 6.5 Contractor furnished containers shall be kept neat, in clean and sanitary appearances, repaired or replaced as necessary. 7. Containers 7.1 The Contractor shall provide containers which are in good condition, have tight fitting lids, are durable, rigid, puncture resistant, do not leak, and which are labeled, color-coded, clearly marked (or mark-able). 7.2 Inspection for leaks and corrosion shall be performed routinely by the Contractor prior to furnishing containers to VA. Containers shall be lined with plastic bags. VA medical facility employees may distribute containers throughout the using facility and will return them to the waste pick-up area. 8. Documentation 8.1 The manifest is an Environmental Protection Agency (EPS) form entitled EPA Form 8700-22 (Rev. 3-05) which is used to track the subject waste from the point of generation to the designated disposal location. http://www.epa.gov/epawaste/hazard/transportation/manifest/pdf/newform.pdf 8.2 Once the material has reached the disposal facility, a copy of the manifest and certificate shall be provided to the Contracting Officer s Technical Representative (COR), confirming that the material has been properly handled and disposed of. 8.3 The Contractor shall provide a manifest for each pick-up, certifying the number of containers and types of waste picked up and removed and transported from the facility, and, upon destruction of the waste, shall provide appropriate copies of the manifest form to indicate date, place, and manner of destruction and/or disposal. The COR will keep its copy on file in accordance with agency guidelines. 9. Monthly Report 9.1 The Contractor shall also provide, in accordance with applicable regulation, a detailed daily activity statement which shows in columnar form information including, but not limited to, the service date, container/tub number, weight (in pounds), pick-up location and other important data. Data shall be supplied and accessible in real-time via a website used for such reporting. The COR shall be issued login credentials for 24-hour access of information. 9.2 This tracking document shall be provided to the COR and VA Industrial Hygienist of the facility on a monthly basis, along with invoice. The Industrial Hygienist s name, telephone number and address will be provided to Contractor at the time of award by the COR. 10. Weighing System 10.1 The contractor shall provide a certifiable weighing system to enable proper billing for tare weight waste poundage disposed, i.e., if the disposal container weighs 10 pounds and the Contractor is to dispose of 10 containers, each container shall be weighed, and container total weight (100) pounds is subtracted from the gross container weight to determine the total waste poundage to be paid. 11. Safety Training 11.1 Contractor shall provide a yearly/as needed in-service training to VA employees; training shall be coordinated with the COR. Training shall include methods on how to identify and handles infectious waste with special emphasis on Right to Know compliance. 11.2 Contractor shall comply with the Nevada Division of Occupational Safety and Health Agency regulations, these regulations can be accessed at http://www.dtsc.ca.gov/ on workers safety standards and related training. 11.3 All Contractors personnel involved in the performance of this contract shall have received training regarding the handling of infectious materials, and emergency procedures to be followed in case of a spill. Certification of such training shall be provided within fifteen days of receiving notice of award of the contract. Certification for any new employees shall be provided to the COR within thirty (30) days of receipt of said training. 12. Interference to normal function Contractor s personnel are required to interrupt their work at any time to avoid interference with patient care procedures and the normal function of the facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment, and carts. PICKUP SCHEDULE/LOCATIONS AND ANNUAL QTY ESTIMATES VA Palo Alto Health Care System Requirements: Services shall be provided at seven facilities; and frequency of pick-ups is identified below. The size of containers to be furnished shall be 44 gallon +/- 10 percent for biohazardous waste and 30 gallon for chemotherapy waste. DAILY PICK-UP: Line Est. Item Description Qty Unit B.6.1. VA Palo Alto 265,689 lbs 3801 Miranda Ave. Palo Alto, Ca 94304 Est. Weight: 265,689 lbs/yr Pick-up Locations: Building 100 (back-dock), including cold storage area Building 710 (VMU) (back-dock) Building 520 (Caged area behind building) Building 7 (Back Dock) TWICE-WEEKLY PICK-UP: Line Est. Item Description Qty Unit B.6.2. VA Menlo Park 4,000 lbs 795 Willow Road Menlo Park, CA 94025 Est. Weight: 4,000 lbs/year Pick-up Location: Building 334 (back-dock), Bldg. 360 (back dock) B.6.3. VA Livermore 8,000 lbs 4951 Arroyo Road Livermore, Ca 94550 Est. Weight: 8,000 lbs/year Pick-up Location: Building 64 Building 90 ONCE A WEEK PICK-UP: Line Est. Item Description Qty Unit B.6.5. VA Clinic Monterey 1,300 lbs 201 9th Street Marina CA 93933 Est. Weight: 1,300 lbs/year Pick up location: Biohazardous storage area back of clinic B.6.6. VA San Jose Clinic 2,000 lbs 58855 Silver Creek San Jose, CA 95138 Est. Weight: 2,000 lbs/year Pick-up Location: Behind the Bldg. B.6.7. VA Fremont Clinic 2,000 lbs 39199Liberty Street Fremont, CA 94538 Est. Weight: 2,000 lbs/year Pick-up Location: Behind the Bldg. Point of Contact: Jennifer Zhang Telephone: 650-493-5000 ext. 67378 QUARTERLY PICK-UP: Line Est. Item Description Qty Unit B.6.7. VA Medical Clinic Capitola 100 lbs 1350 41st Ave. STE 102 Capitola CA 95010 Est. Weight: 100 lbs/year Pick up location: Check-In Desk Attachment A Quality Assurance Surveillance Plan Regulated Medical Waste Removal and Treatment Services PURPOSE This Quality Assurance Surveillance Plan (QASP) is a government developed and applied document used to make sure that systematic quality assurance methods are used in the administration of the Performance Based Service Contract (PBSC) standards included in this contract. The intent is to ensure that the Contractor performs in accordance with performance metrics set forth in the contract documents, that the Government receives the quality of services called for in the contract and that the Government only pays for the acceptable level of services received. SCOPE To fully understand the roles and the responsibilities of the parties, it is important to first define the distinction in terminology between the Quality Control Plan and the Quality Assurance Surveillance Plan. The Contractor, and not the Government, is responsible for management and quality control actions necessary to meet the quality standards set forth in the contract. The Contractor develops and submits his/her Quality Control Plan (QCP) for Government approval in compliance with his contract deliverables. Once accepted, the Contractor then uses the QCP to guide and to rigorously document the implementation of the required management and quality control actions to achieve the specified results. The QASP on the other hand, is put in place to provide Government surveillance oversight of the Contractor s quality control efforts to assure that they are timely, effective and are delivering the results specified in the contract. The QASP is not a part of the contract, nor is it intended to duplicate the Contractor s QCP. The Government may provide the Contractor an information copy of the QASP as an Attachment to the solicitation to support the Contractor s efforts in developing a QCP that will interrelate with the Government s QASP. GOVERNMENT RESOURCES/RESPONSIBILITIES The following personnel shall oversee and coordinate surveillance activities. a. CONTRACTING OFFICER: The Contracting Officer (C.O.), ensures performance of all necessary actions for effective contracting, ensures compliance with the terms of the contract and safeguards the interests of the United States in the contractual relationship. It is the Contracting Officer that assures the Contractor receives impartial, fair, and equitable treatment under the contract. The Contracting Officer is ultimately responsible for the final determination of the adequacy of the Contractor s performance. Assigned CO: John Da Silva Organization or Agency: Department of Veterans Affairs, NCO 21 b. Contracting Officer s Representative (COR) - The COR provides detailed technical oversight of the Contractor s performance and reports his or her findings to the C.O. in a timely, complete and impartial fashion The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government s behalf. Any changes that the Contractor deems may affect contract, price, terms, or conditions shall be referred to the Contracting Officer for action. Assigned COR: Jennifer Zhang METHODS OF QA SURVEILLANCE The below listed methods of surveillance shall be used in the administration of the QASP. In addition to specific instructions that may be mentioned, the appropriate and standardized form that is to be used for documentation of QA surveillance is the Surveillance Activity Checklist, included as Attachment A. Customer Feedback Customer feedback may be obtained either from the results of formal customer satisfaction surveys or from random customer complaints. Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed and forwarded to the COR. The COR shall maintain a summary log of all formally received customer complaints as well as a copy of each complaint in a documentation file. The COR shall also keep the tabulated results of all customer satisfaction surveys on file and shall enter the summary results into the Surveillance Activity Checklist. (Copies of all records shall be submitted to the CO upon receipt for placement in the official contract file, and when necessary, determination of actions.) 100% Inspection The COR shall monitor each patient delivery and enter performance results into the Surveillance Activity Checklist. Periodic Inspection - Periodic inspections shall be conducted when specified in the contract/PWS. For the potential tasks that have been identified so far and included in this QASP, the COR performs the periodic inspection on a monthly basis. Random Monitoring - Random monitoring shall be conducted if and when specified in the contract. For the potential tasks that have been identified so far and included in this QASP, the random monitoring shall be performed by the COR. 5. PERFORMANCE STANDARDS The Performance Requirements Summary in the Performance Work Statement (PWS) includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL) and determine incentives. Performance Requirements Table Quality Assurance Surveillance Plan: Required Service Standard Performance Requirement (PR) Method of Surveillance Factors to consider for Option Year Renewal Safety Requirements in accordance with paragraph D.14 of the Performance Work Statement All requirements as listed under this paragraph must be followed. Contractor is required to respond for compliance COR Complaint that a contractor-caused incident occurred which compromised the safety of individuals. Yes Maintaining separation of types of waste, Red Bag, Pathology and Chemotherapy. See Procedures under D.16, Infectious Medical Waste Require-ments Memo Adherence to procedures under D.16 COR Complaint that these procedures were not followed. Yes Adherence to Pick Up schedules in Section B, Line Item Pricing Schedule All Pick Up Schedules adhered to. See Schedule B, Line Item Pick Up and Pricing Schedule COR Complaint that Pick Ups were missed. Yes 6. INCENTIVES The Government shall use payment deduction as incentives for Contractors to maintain acceptable performance level. Incentives shall be based on meeting, or not meeting performance standards. The CO and COR shall monthly progress meetings to assess performance and shall provide a written assessment. Should the CO experience marginal or sub-standard performance, they should consider more frequent progress meetings.