36C24719Q0330-001.docx

STATEMENT OF WORK

REGULATED MEDICAL WASTE AND REUASABLE SHARPS CONTAINER DISPOSALS

A. GENERAL:

1. Regulated Medical Waste (RMW) disposal includes but is not limited to items contaminated with blood and body fluids/waste, chemotherapy wastes, sharps, pathological and microbiological waste or other potentially infectious materials and the collection, packaging, transport, and incineration or otherwise disposal of medical waste materials in accordance with all applicable Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Department of Transportation (DOT), Occupational Safety and Health Administration (OSHA) and any other state and federal requirements or guidelines.

2. A turnkey service program for all sharps, providing reusable containers, mounting brackets, carts, and interim storage containers for transport must be available once the contract period of performance begins.

3. Contractor is responsible for providing a contingency plan identifying how they will ensure continuity of services in the event of inclement weather, driver absence or equipment failure.

4. Contractor will utilize landfills within the industry that transforms waste to clean, renewable energy.

B. WORK HOURS:

1. Normal Work Hours: The service schedule will be developed between the contractor and Contracting Officer Representative prior to services being performed, but will generally be performed during normal business hours, 7:00am-5:30pm, Monday-Saturday.

2. National Holidays: The ten holidays observed by the Federal Government are: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day .and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

C. SPECIFICATIONS:

1. Regulated Medical Waste:

a. For regulated medical waste, the contractor shall furnish sufficient number of 30-50 gallon (approximate), red plastic, puncture proof tubs with snap tight lids, a red plastic liner for each tub, applicable labels required by law, all required documentation, pick-up, and disposal of infectious waste (and non-hazardous pharmacy drugs) based on the estimated weekly infectious waste of 2400 pounds at the Main Campus (Ralph H. Johnson VA Medical Center. 109 Bee Street, Charleston, SC 29401) and various volumes as outlined in Attachment A for our offsite locations. Pick-ups will normally be scheduled at a minimum of twice per week (Tuesday and Friday) for the main campus and as outlined in Attachment A for our satellite locations. If quantities increase or decrease, pick-ups shall be adjusted accordingly.

b. For regulated medical waste, all contractor provided containers shall be leak-proof, stackable, sealable, and transportable. All containers will be large enough to place regulated medical waste in red bag without manipulation. Containers will be designed so that government employees will not be required to lift more than 35 lbs., and shall display the universal biohazard symbol. All containers shall be damage free and in good working order at all times.

c. For regulated medical waste, all containers must be identifiable as to the type of hazardous waste contained within, (i.e. yellow for chemo, red for medical waste) all containers shall be approved by the COR.

d. For regulated medical waste, contractor will remove full containers and replace them with an equal number of empty sanitized containers at the designated centralized regulated medical waste storage area. Sanitizing shall be completed by the contractor off-site.

2. Reusable Sharps Containers

a. Contractor shall provide the necessary quantities of reusable sharps containers in varying sizes from 2 to 19 gallons, wall mounting brackets, and carts capable of keeping reusable containers tamper resistant throughout the Main Campus (Ralph H. Johnson VA Medical Center. 109 Bee Street, Charleston, SC 29401) and at one offsite locations. Pick-ups will normally be scheduled at a minimum of twice per week (Tuesday and Friday) for the main campus and as outlined in Attachment B for the offsite locations. If quantities increase or decrease, pick-ups shall be adjusted accordingly.

b. Reusable sharps containers will be puncture proof, preassembled, leak proof, lockable, with sight/view port, and overfill protection. Containers will have large access opening with restricted hand access, prohibiting a child or adult from accessing. Surgical procedure areas and lab areas will be provided open top containers.

c. Reusable sharps containers must meet all state, federal, Department of Transportation (DOT), Food and Drug Administration (FDA) Occupational Safety and Health Administration (OSHA) standards for collection, storage, and transport of medical waste and sharps.

e. Contractor shall provide and keep all reusable sharps containers and carts clean and in good repair, i.e. wheels, and openings.

f. Contractor will be responsible for removal and disposal of existing sharps containers and brackets.

g. Contractor is responsible for the removal and installation of any old and new bracketing systems at no additional cost to the government. Contractor must make every effort to install new containers in the same location as existing bracketing to be removed/replaced. All brackets must be securely mounted. Placement will normally be in accordance with industry standard ergonomic practices, whenever possible.

h. The contractor is responsible for providing a manifest of all items picked up for (number of containers, weights, and sizes) at the time of pick-up to the COR of their designee. A detailed destruction manifest of all medical sharps containers transported from the VAM Medical Center to include the date of pick up, location and the weight of content of the containers as well as the date and place of destruction is to be provided to the COR within thirty (30) calendars days of destruction.

d. Contractor is responsible for providing 510K document demonstrating approval by the FDA for reusable sharps containers and the number of usage.

i. The contractor is responsible for delivering replacement reusable sharps containers in sufficient quantities and that are certified to have been cleaned/sanitized and are in proper working condition prior to delivery to the medical center.

j. The contractor will provide additional containers, brackets, and carts based on medical center’s needs, and at no additional cost to the government. COR will provide adequate notice (normally two weeks).

3. Collection, packaging, transport, and incineration or otherwise disposal of medical waste materials in accordance with all applicable Environmental Protection Agency (EPA), Department of Transportation (DOT), Occupational Safety and Health Administration (OSHA) and any other state and federal requirements or guidelines.

4. Upon notification by the COR of an emergent need for service, the contractor will address within 24 hours of notification, unless mutually agreed upon by both the contractor and COR, i.e. on the next scheduled service delivery date.

D. DOCUMENTATION FROM THE CONTRACTOR:

1. The contractor shall prepare and submit to the COR an original signed Certificate of Destruction for each pick up at the time of pick up, and will provide an electronic copy upon request.

2. The contractors will provide any incidences of noncompliance with state, federal, or local environmental, health or safety laws and regulation that have taken place during the past 5 years, including those that were satisfactorily settled, those that resulted in no fines or legal action, and any other noncompliance incidences.

3. The contractor shall maintain proper records concerning each Certificate of Destruction issued. The Certificate of Destruction shall at a minimum contain the following:

· Pickup/Delivery Location

· Pickup/Delivery Date

· Amount of waste (number of containers picked up and/or pounds)

· Destruction Certification Document/Manifest Number

· Destruction Certification Date

· Any other information as required by the COR.

4. The contractor will provide a monthly “weight report” of total sharps weight processed, as well as a total weight report of plastics diverted from the landfill, no later than the 8th of each month.

E. TRAINING REQUIRED BY THE CONTRACTOR: The contractor is responsible for training medical center staff on the use, handling and care of reusable sharps containers. Training will be documented and provided to multiple shifts (24 hours) at several designated times during installation, as determined by the COR. The contractor will provide annual training to government staff as required by the COR, and will include, but is not limited to, proper handling of medical/special waste; interim storage requirements, proper identification and labeling of wastes, reusable sharps containers, etc.

F. QUALITY ASSURANCE/CONTROL:

1. The contractor shall have a quality control program to ensure the requirements of this contract are provided as specified. The program will include, but will not be limited to the following:

a. An inspection system covering the services listed in this statement of work. It must specify areas of work to be inspected on a scheduled basis.

b. A method of identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable which would include ensuring products delivered are clean.

c. A record of all inspection conducted by the contractor and corrective action(s) taken. These documents will be made available to the government during the contract. A quarterly report of inspections will be provided on January 15th, April 15th, July 15th, and October 15th in each contract year.

2. The Government will investigate complaints from the Ralph H. Johnson VAMC and affiliated sites. All information received will be provided either verbally and/or in writing to the contractor for appropriate action.

2nd Occurrence) 10% of monthly invoice. 3rd and subsequent offenses will be 20% of monthly invoice amount.

G. CONTRACTOR PERSONNEL, BADGES AND PARKING:

1. While on VA premise, all contractor personnel shall comply with the rules, regulations, and procedures governing conduct of personnel and the operation of the facility.

2. An Access Badge will be given to the contractor’s employee upon entrance into VA buildings, unless under escort by a government employee. The contractor employee must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the COR. All contract personnel must properly display their access badges. Access badges must be worn at or above the waist (facing forward). The contractor’s employee must return access badges to the COR or designee at the end of each pick-up process.

3. It is the responsibility of the contractor personnel to park in appropriate designated spaces. Parking information shall be coordinated with the COR. The government does not validate or make reimbursement for parking violations of contracted personnel under any circumstances.

4. The contractor shall be required to comply with all security policies/requirements of the Ralph H. Johnson VA Medical Center and Joint Base Charleston. All security policies/requirements must be met and employees cleared prior to the contractor performing work under this contract. Employees that cannot meet the security clearance requirements shall not be allowed to perform work under this contract.

5. The contractor will be provided keys or allowed access to all areas where reusable sharps containers are installed or centrally collected when full. Keys provided to the contractor shall not be duplicated. In the even that a key is lost or duplicated, all locks and keys on that system will be replaced by the government. The contractor shall be responsible for the total cost involved in replacing keys and cores. The contractor shall be responsible for immediately reporting the occurrence of a lost key to the COR or their designee.

6. Contracted employees shall not allow any unauthorized person to use any keys or badges in their possession. They shall not open locked rooms or areas to permit entrance by persons other that contractor employees performing assigned duties. All rooms and areas will be secured by contractor personnel after completion of duties.

H. INTERFERENCE TO NORMAL FUNCTION:

1. Contractor may be required to interrupt their work at any time so as not to interfere normal functioning of the facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment and carts.

2. In the event of an emergency, contractor services may be stopped and rescheduled at no additional cost to the government.

3. Contractor personnel shall inform the COR or designee of the need to gain access to secure areas. If access is required to secure access, prearranged scheduling will be made with the COR or designee.

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