Draft Performance Work Statement 5-1-2024.docx

B.3 PERFORMANCE WORK STATEMENT

Draft Biohazardous Waste Removal Services for the VA Northern California Health Care System (VANCHCS) May 1, 2024

CONTRACT REQUIREMENTS

D.1 GENERAL REQUIREMENTS

D.1.1. The Contractor shall furnish all labor, disposal equipment, containers that are appropriately sanitized, disinfected and labeled supplies, materials, labels, shipping containers and boxes, plastic bags, transportation and supervision required for pick-up, transport, and treatment services of biohazardous waste from various Department of Veterans Affairs (henceforth referred to as “VA”) Northern California Health Care System (VANCHCS) medical facilities, and shall ensure proper management of Biohazardous Waste Compliance, Pharmaceutical Waste Compliance and Sharps Management services

D.1.2. The Contractor shall treat and/or dispose of biohazardous medical waste in accordance with all applicable State and Federal regulations, and VA requirements. Contractor shall maintain all necessary permits and licenses for the transportation, disposal, and treatment of such waste as required by the California Department of Public Health, US Department of Transportation, and be a registered hazardous waste transporter with a current registration certificate issued by the State of California and have all required insurances prior to the transport and/or disposal of subject waste. If contractor requires additional information, they may contact the California Department of Public Health, Medical Waste Program.

D.1.3. A copy of all required licenses, permits, proof-of-insurances, and a detailed list of all environmental regulatory agency violations for the past 3 years shall be provided to Contracting Officer at solicitation and annually after award to the Contracting Officer’s Representative (COR).

D.1.4. Period of Performance:

This contract will be an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The ordering period for the IDIQ contract will be five years from the date of award.

D.2. DEFINITIONS

D.2.1 BIOHAZARDOUS WASTE: Waste generated from the diagnosis, treatment, or immunization of human beings or animals, or research pertaining to these activities. There are five (5) waste streams that include but is not limited to: waste with recognizable blood contamination, materials isolated by infection control staff, waste chemotherapy materials, pathological waste, sharps waste, and pharmaceutical waste. All biohazardous waste may also contain waste that is infectious or contagious, human, or animal surgery specimens, fluids or tissues.

D.2.1.1 CHEMOTHERAPY WASTE: Discarded items which have been contaminated by chemotherapeutic agents and are empty (i.e. remaining contents are not pourable). It includes bags, containers, vials, syringes, gauze, gloves, etc. This waste stream must be incinerated.

D.2.1.2 MEDICAL WASTE: Waste generated in the process of diagnosis, treatment and/or immunization of humans or animals. It is the highest volume of all of the waste streams. It includes trauma-scene waste.

D.2.1.3 PATHOLOGICAL WASTE: Human samples that have been fixed in formaldehyde or other fixatives, and recognizable human anatomical parts. This waste stream must be incinerated.

D.2.1.4 PHARMACEUTICAL WASTE: Any prescription or over the counter human or veterinary drug that is expired, unusable or cannot be returned to the supplier, and is NOT pharmaceutical waste regulated under the federal Resource and Conservation and Recovery Act (RCRA), the Radiation Control Act, or Controlled Substance Act (CSA). This waste stream must be incinerated.

D.2.1.5 SHARPS WASTE: Any device with potential biohazardous contamination having acute rigid corners, edges, or protuberances capable of cutting or piercing including; syringes, needles, needles with attached tubing, acupuncture needles, blades, and root canal files. Also includes broken glass items, such as pipettes, and blood vials contaminated with biohazardous waste. This waste stream must be incinerated or autoclaved.

D.2.2 TRANSFERRING: Section 118035 of the California Health and Safety Code requires that all biohazardous waste be transported by a single registered hazardous waste hauler directly to a permitted medical waste treatment facility. Medical waste shall not be unloaded, reloaded, or transferred to another vehicle at any location, except at a permitted medical waste transfer station or in the case of a vehicle breakdown or other emergency.

D.2.3 CALIFORNIA MEDICAL WASTE MANAGEMENT ACT (CMWMA): Formally known as California Administrative Code, Title 17, Health & Safety Code, Sections 117600 – 118360. This is the primary set of regulations governing the storage, transportation, treatment and disposal of biohazardous waste. The contractor will comply with all applicable provisions of this regulation.

D.2.4 CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (CDPH): The Medical Waste Management Program Unit of this agency has primary responsibility for the regulations regarding biohazardous waste. Local agencies have been empowered by CDPH to issue permits, conduct inspections, and enforce the regulations.

D.2.5. HAZARDOUS MATERIAL: “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.

D.2.6 HAZARDOUS WASTE: “Hazardous waste” means any waste material or mixture of wastes which is regulated under the Federal Resource and Conservation and Recovery Act (RCRA).

D.2.7 US DEPARTMENT OF TRANSPORTATION (US DOT): The US Department Of Transportation is responsible for regulating the shipping containers and labeling of waste, placarding of shipping vehicles, and the transportation of waste.

D.3 TRANSPORTATION: Biohazardous waste shall be transported in accordance with California Administrative Code, Title 17, Health & Safety Code, Chapter 8, and is permitted by the California Department of Public Health.

D.3.1 VEHICLE REGISTRATION: The contractor shall be a registered hazardous waste transporter with a current registration certificate issued by the State of California. A current copy shall be maintained in every vehicle at all times and shall be made immediately available to the COR for review upon request.

Vehicles will be placarded in accordance with US Department of Transportation regulatory requirements.

D.3.2 US DOT PRE-TRANSPORTATION FUNCTION:

The contractor is responsible for performing the specific requirements under “Pre-Transportation Function” found in 49 CFR 171.8 as required to assure the safe transportation of a hazardous material. This includes proper shipping documents, packaging, labeling, placarding, inspection and other requirements.

D.3.3 DOT SHIPPING CONTAINERS: Shipping containers shall meet US DOT requirements. They shall be cleaned and disinfected before being brought to any site in accordance with CMWMA requirements. This includes the lids. All labels required by the CMWMA will be provided by the contractor. Labels for “PATH”, “WASTE CHEMO”, “SHARPS”, and “WASTE PHARM” will be provided to the sites so that shipping containers holding these waste streams can be properly labeled, as required by the CMWMA, during storage. Contractor furnished shipping containers shall be kept neat, in a clean and sanitary appearance, and repaired or replaced as necessary. The area where unused shipping containers are placed shall be maintained in a clean, orderly, and sanitary condition.

D.3.4 SPILL CLEAN-UP: Particular attention shall be paid to the prompt clean-up of spills, either generated from the vehicles used to haul waste containers or because of container leakage. Issues associated with site storage lockers shall be brought to the immediate attention of the COR.

D.3.5 LIST OF SITES AND WASTE STREAMS: The comprehensive list of waste streams, pick-up locations, frequency of pick-ups, and minimum stock levels of shipping containers for each site is maintained by the COR. It is subject to being updated, as needed, by the COR.

D.4 TREATMENT AND DISPOSAL: Contractor shall employ the best environmentally sound methods of treating and destruction of wastes such as incineration and sterilization or any other acceptable methods, in accordance with U.S. EPA and California Department of Public Health standards and regulations. Disposal shall also be performed in such a manner as not to create conditions detrimental to public health or to constitute a public nuisance. Biohazardous waste shall be treated by one of the following methods, in accordance with California Administrative Code, Title 17, Health & Safety Code, Chapter 8, and is permitted by the California Department of Public Health Acceptable treatment methods include:

· Steam sterilization at a permitted facility,

· Incineration at a permitted facility, or

· Treatment with an alternative technology at a permitted facility, D.4.1 ALLOWABLE TREATMENT METHODS:

· Medical Waste: Any of the above methods.

· Sharps Waste: Any of the above methods.

· Chemotherapy Waste: Incineration or a CDPH approved/permitted alternative technology.

· Pathological Waste: Incineration or a CDPH approved/permitted alternative technology.

· Pharmaceutical Waste: Incineration or a CDPH approved/permitted alternative technology.

D.4.2 CDPH PERMITTED FACILITIES: The contractor shall use only Transfer Stations and Treatment/Disposal Facilities permitted by CDPH and approved by the COR for this contract. The contractor shall submit to the COR the names and copies of required certifications and licenses of proposed facilities prior to using any facilities on this contract. The COR shall be final approval authority to use any proposed facilities. The contractor shall provide the COR updated facility or permit information upon renewal or expiration of any permit. Additionally, the contractor shall provide upon request from the COR a summary of all regulatory violations for the prior 3 years.

D.5. QUALITY ASSURANCE

D.5.1 For the tasks listed in the Performance Requirement Table (PRT) below, the COR will follow the methods of surveillance specified in this contract.

D.5.2 When a required service in the PRT indicates defective performance, the COR will require the contract manager or representative at the site to document the observation and forward to the Contracting Officer to maintain in the file. The documentation of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that he or she has been made aware of the defective performance. Government surveillance of tasks not listed in the PRT or by methods other than those listed in the PRT (such as provided for by the Inspection of Services clause) may occur during the performance period of this contract. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the contracting officer as a result of surveillance will be in accordance with the terms of this contract.

D.5.3 Performance Requirements Table – Quality Assurance Surveillance Plan:

Requirement (PR)

Option Year Renewal

Providing Adequate Shipping Containers and Labels As Required In Sections D.3.3, D.3.5, and D.6.

Schedules adhered to.

See Schedule B, Line Item Pick Up and Pricing Schedule

Properly classify, label, and identify waste that is collected and shipped on manifest

No more than one non-performance per quarter.

Customer Complaints, and random sampling

Yes

Respond to requests or questions within 48 hours

No more than one non-performance month

Customer Complaints

Yes

Licenses and permits up to date and submitted annually

100% Compliance

compliance

Yes

Training records up to date and submitted annually

100% Compliance

all training records

Yes

Submit timely invoices that include all necessary supporting documents

100% Compliance

all training records

Yes

D.6. SHIPPING and SHARPS CONTAINERS

D.6.1. The Contractor shall provide, as part of the unit prices stated in Section B, shipping containers which are in good condition, clean, disinfected, have tight-fitting lids, durable, rigid, puncture-resistant, do not leak, and which are properly labeled, color-coded, clearly marked (or markable). Inspection for leaks and corrosion shall be performed routinely by the Contractor prior to furnishing containers to VANCHCS. Disposable containers shall be lined with red plastic bags that meet US DOT regulatory requirements. VA medical facility employees may distribute containers throughout the using facility and will return them to the waste storage pick-up area.

D.6.2. The contractor shall provide all regulatory-required labels for all shipping containers. Waste streams shall be properly labeled as required by CMWMA regulations.

D.6.3. The contractor may provide appropriate safe and sustainable containers, and container holders, as a standard service that provides comingling prevention and solutions for combining sharps and non-hazardous pharmaceutical waste in one reusable container, that ensures Pharmaceutical Waste Compliance and Sharps Management services.

D.7. DOCUMENTATION

D.7.1. The shipping document is required by CMWMA regulations and is used to track the waste from the point of generation to the designated disposal location. Upon request from the COR, a copy of the document and certificate-of-destruction shall be provided to the Contracting Officer or COR, confirming that the material has been properly handled and disposed. The Contractor shall provide a clearly readable copy of the shipping document for each pick-up.

D.7.2. At the time that the medical waste is picked up by the contractor, the transporter shall provide the medical waste generator with a copy of the tracking document for the generator’s medical waste records. The transporter and generator of medical waste shall maintain its copy of the tracking document for at least three years. The tracking document shall include, but not be limited to, all of the following information:

· The name, address, telephone number, and registration number of the transporter,

· The type and quantity of shipping containers of each type of biohazardous waste transported.

· The name, address, and telephone number of the generator site.

· The name, address, telephone number, permit number of the permitted facility receiving the waste.

· The date that the medical waste is collected or removed from the generator’s facility, the date that the medical waste is received by the transfer station, point of consolidation, if applicable, and the date that the waste is received by the treatment facility.

· The final copy of the biohazardous waste shipping document that has been signed by the disposal site must be sent to the Site Manager for each pick-up location.

D.7.2. REPORTS: The Contractor shall also provide, in accordance with applicable regulation, a detailed activity statement which shows in columnar form information including, but not limited to, the service date, pick-up location, container/tub number, weight (in pounds) of each container, type of waste stream, disposal method, disposal location, and other important data, as requested by the COR. The report shall have the capability to segregate data by site and type of waste. This report shall be provided monthly and for each fiscal year. The format of the report shall be approved by the COR and is subject to changes as requested by the COR.

Safety Officer’s name, telephone number and address will be provided to Contractor at the time of award.

D.7.3. WEIGHING SYSTEM: 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 recorded. Scales shall be calibrated by a third-party vendor and proof of calibration will be provided to the COR upon request.

D.8. SERVICE LOCATION / FREQUENCY OF PICKUPS FOR VANCHCS:

D.8.1 The following are the sites to be serviced and minimum pick-up frequency. Other locations may be added as needed by the COR. Pick-up frequencies are subject to change by the COR.

Daily Pickup (M-Sat) Weekly Pickup

Monthly Pickup Weekly Pickup Yuba City VA OPC Chico VA OPC / Annex 425 Plumas St. 1601 Concord Avenue Yuba City, CA 95991 Chico, CA 95928

Weekly Pickup Weekly Pickup Redding VA OPC Mare Island OPC 351 3455 Knighton Road. 201 Walnut Ave.

Redding, CA 96002 Mare Island, CA 94592

Twice Per Week Pickup (M & TH) Weekly Pickup Martinez VA OPC / CLC Fairfield VA OPC 150 Muir Rd. 103 Bodin Circle Bldg. #778 Martinez, CA 94553 Travis AFB, CA 94535

Monthly Pickup Redding Dental/Rehab Clinic Suite 351 760 West Cypress Ave, Ste 100. Redding, CA 96001

Weekly Pickup Stockton VA Clinic 7777 Freedom Rd.

French Camp, CA 95231 (Possibility this location will no longer be a part of packet as of 8/1/24, as we are transitioning.

from the old Stockton location)

D.8.2. Perspective clinics, resulting from expansion within the VANCHCS shall be added through contractual modification of service obligations. Any additional sites within the VA Northern California Health Care System, that results in a 50% increase or decrease of service obligations will be considered in-scope.

D.9 SAFETY TRAINING

D.9.1. Contractor to provide training as required by all applicable regulations to its’ employees. Copies of training records and training materials shall be provided to the VANCHCS COR upon request.

D.9.2. Contractor shall comply with all applicable California Division of Occupational Safety and Health Agency regulations on workers’ safety standards and related training. All Contractor 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 must be provided within fifteen days of receiving notice of award of the contract. It shall include a list of all safety and environmental training courses provided to all personnel that handle biohazardous waste, a detailed summary of what is covered in each course, and the frequency of training. Certification for any new employees shall be provided to the VANCHCS COR upon request.

D.10. INTERFERENCE TO NORMAL FUNCTION

Contractor 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. Vehicles shall not obstruct the flow of other vehicles.

D.11. MODIFICATION

Any modification to the contract shall be in writing. The modification will be prepared by the VA Contracting Officer prior to becoming effective.

D.12. GOVERNMENT HOLIDAYS:

3rd Monday in February

Memorial Day

Last Monday in May

Independence Day

July 4

Labor Day

1st Monday in September

Columbus Day

2nd Monday in October

Veterans Day

November 11

Thanksgiving Day

4th Thursday in November

Christmas Day Juneteenth

December 25 June 19th

Any other day designated by the President as a national holiday. When one of the holidays falls on a Sunday the following Monday will be observed as a legal holiday. When holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by US Government agencies.

D.13. SERVICE HOURS

Contract services shall take place from 8:00 a.m. to 4:30 p.m. with the exception of Mather. Mather must be picked up between 6 a.m. – 10 a.m. Should the day for pick-up fall on a holiday, pick-up is to take place on the next regularly scheduled workday.

D.14. Safety Requirements:

The contractor shall exercise safety precautions, as deemed necessary by the Contracting Officer or his/her designee during the performance of the contract, in order to protect lives and health. The Contracting Officer/designee will notify the Contractor of any noncompliance with the foregoing provisions and advise the contractor of the action to be taken. After receipt of such notice, the Contractor shall immediately initiate corrective action. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue a stop-work order for all or any part of the work and hold the Contractor in default as provided elsewhere in this contract.

D.15. DESIGNATION OF CONTRACTING OFFICER’S REPRESENTATIVE (COR)

A Representative of the Contracting Officer (COR) will be designated to represent the Contracting Officer in furnishing technical guidance and advice under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to Contractor relative to the financial or legal aspects of the contract. Those matters are the responsibility of the Contracting Officer and shall not be delegated.

D.16 RECORDS MANAGEMENT LANGUAGE

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.