The Biomedical Waste Operating Plan form serves a crucial role in guiding facilities on the correct management and disposal of biomedical waste, ensuring both environmental safety and compliance with regulatory standards. Specifically, it outlines procedures and requirements, according to the Florida Administrative Code (Chapter 64E-16) and the Florida Statutes (section 381.0098), for the handling, labeling, storage, and transportation of biomedical waste. For detailed guidance on completing this form and maintaining regulatory compliance, faculty administrators are encouraged to click the button below.
Managing biomedical waste is a critical aspect of healthcare operations, aimed at preventing the spread of infections and ensuring environmental safety. Amidst various regulations, the Biomedical Waste Operating Plan form serves as a comprehensive guide for facilities to properly handle and dispose of such waste. Updated on October 5, 2005, by the Florida Department of Health under the authority of Jeb Bush, then Governor, and M. Rony François, M.D., M.S.P.H., Ph.D., as Secretary, this packet is not just a formality but a crucial part of healthcare management. It encompasses directions for completing the operating plan, purpose, personnel training, definition, identification, and segregation of biomedical waste, alongside procedures for containment, labeling, storage, transport, decontaminating spills, and a contingency plan for emergencies. Moreover, it outlines the necessity of maintaining a clean and safe storage area away from client traffic, keeping accurate records of training and waste management practices, and ensuring that facilities use approved red bags for waste that meet specific construction requirements. This plan, by detailing every aspect of biomedical waste management from generation to disposal, including training outlines and the attendance of personnel to receive proper training, exemplifies the meticulous consideration required to protect public health and the environment from the potential hazards of biomedical waste.
Jeb Bush
M. Rony François, M.D., M.S.P.H., Ph.D.
Governor
Secretary
____________________________________________________________________________________________
BIOMEDICAL WASTE
PACKET
(Revised October 5, 2005)
CONTENTS:
1.Sample BIOMEDICAL WASTE OPERATING PLAN (DOH/MCHD) (with Instructions & Valuable Websites).
2.Recommended procedure;
DECONTAMINATING BIOMEDICAL WASTE SPILLS
3.Recommended: “SPILL KIT” CONTENTS
4.Chapter 64E-16; Florida Administrative Code (FAC)
5.Florida Department of Health
“Application for Biomedical Waste Generator Permit/Exemption”
6.Sample “Attachment A”
Biomedical Waste Training Outline
7.Two Samples of “Attachment B”
Biomedical Waste Training Attendance
8.Order Blank for Biomedical Waste Training Video
Aug-06
Manatee County Health Department
ENVIRONMENTAL HEALTH SERVICES
410Sixth Avenue East • Bradenton 34208-1928 PHONE (941) 748-0747 • FAX (941) 750-9364
BIOMEDICAL WASTE OPERATING PLAN
FACILITY NAME (1)
TABLE OF CONTENTS
I.DIRECTIONS FOR COMPLETING THE BIOMEDICAL WASTE PLAN
II.PURPOSE
III.TRAINING FOR PERSONNEL
IV. DEFINITION, IDENTIFICATION, AND SEGREGATION OF BIOMEDICAL WASTE
V.CONTAINMENT
VI. LABELING VII. STORAGE VIII. TRANSPORT
IX. PROCEDURE FOR DECONTAMINATING BIOMEDICAL WASTE SPILLS
X.CONTINGENCY PLAN XI. BRANCH OFFICES XII. MISCELLANEOUS
ATTACHMENT A: BIOMEDICAL WASTE TRAINING OUTLINE
ATTACHMENT B: BIOMEDICAL WASTE TRAINING ATTENDANCE
ATTACHMENT C: PLAN FOR TREATMENT OF BIOMEDICAL WASTE (Not Included; Available upon request)
Use of this plan format is voluntary and not required by the Department of Health. It is provided as a service to assist biomedical waste facilities in complying with the requirements of Chapter 64E-16, F.A.C.
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I. DIRECTIONS FOR COMPLETING THE BIOMEDICAL WASTE PLAN
Blank 1: Enter the name of your facility.
Blank 2: Enter where you keep your employee training records.
Blank 3: List the items of biomedical waste that are produced in your facility and the location where each waste item is generated.
Blank 4: Enter the name of the manufacturer of your facility’s red bags. This company must be
on the Department of Health (DOH) list of compliant red bags (this list can be obtained from the following website: www.doh.state.fl.us/environment/community/biomedical/red_bags.htm) or from your DOH biomedical waste coordinator OR you must have results supplied by the bag manufacturer from an independent laboratory that indicate that your red bags meet the
bag construction requirements of Chapter 64E-16, Florida Administrative Code (F.A.C.). If your facility does not use red bags, enter N/A.
Blank 5: Indicate where the documentation for the construction standards of your facility’s red bags is kept. or if your facility does not use red bags, enter N/A.
Blank 6: Indicate where unused, red biomedical waste bags are kept in operational areas (not in stock or in central storage) so that working staff can get them quickly when they need them. If your facility does not use red bags, enter N/A.
Blank 7: Enter the place where your biomedical waste is stored. 1.How is this area “Washable”?
2.Is this area “Out of the Client Traffic Area” (how)? 3. How is this area’s access restricted? If your biomedical waste is picked up by a licensed biomedical waste transporter
but you have no storage area, indicate your procedure for preparing your biomedical waste for pick-up. If you have no pick-up and no storage area, enter N/A.
Blank 8: Enter all the required information about your registered biomedical waste transporter. The website www.doh.state.fl.us/environment/community/biomedical/transporters.htm has a list of such transporters. If you do not use a transporter, enter N/A.
Blank 9: Enter the name(s) of the employee(s) designated to transport your facility’s untreated biomedical waste to another facility. If your facility does not transport your own biomedical waste, enter N/A.
Blank 10: Enter the name of the facility to which your facility transports your own untreated biomedical waste. If your facility does not transport your own biomedical waste, enter N/A.
Blank 11: Describe the procedure and products your facility will use to decontaminate a spill or leak of biomedical waste.
Blank 12: Enter the required information about the registered biomedical waste transporter who will transport your biomedical waste on a contingency basis.
Blank 13: If personnel from your facility also work at a branch office of your facility, enter the name of the branch office. If you have no branch office, enter N/A.
Blank 14: Enter the street address, city, and state of the branch office named in (13). If you have no branch office, enter N/A.
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Blank 15: Enter the weekdays the branch office named in (13) is open. If you have no branch office, enter N/A.
Blank 16: Enter the normal work hours for each day the branch office named in (13) is open. If you have no branch office, enter N/A.
Blank 17: Indicate where a copy of this biomedical waste operating plan will be kept in your facility.
Blank 18: Indicate where the current biomedical waste permit or exemption document will be kept in your facility.
Blank 19: Indicate where your facility will keep its current copy of the biomedical waste rules, Chapter 64E-16, F.A.C.
Blank 20: Indicate where your facility will keep copies of its biomedical waste inspections from at least the last three (3) years.
Blank 21: If your facility transports your own biomedical waste, indicate where your transport log is kept. If you do not transport your own biomedical waste, enter N/A.
Attachment A: Activities addressed should be those from Section III that are carried out in your facility.
Attachment B: Enter the required information to document training sessions.
Attachment C: To be completed only if your facility treats biomedical waste. If your facility has untreated biomedical waste removed by a registered transporter or you transport your own untreated waste, do not complete this attachment.
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The purpose of this Biomedical Waste Operating Plan is to provide guidance and describe requirements for the proper management of biomedical waste in our facility. Guidelines for management of biomedical waste are found in Chapter 64E-16, Florida Administrative Code (F.A.C.), and in section 381.0098, Florida Statutes.
III. TRAINING FOR PERSONNEL
Biomedical waste training will be scheduled as required by paragraph 64E- 16.003(2)(a), F.A.C. Training sessions will detail compliance with this operating plan and with Chapter 64E-16, F.A.C. Training sessions will include all of the following activities that are carried out in our facility:
Definition and Identification of Biomedical Waste Segregation
Storage
Labeling
Transport
Procedure for Decontaminating Biomedical Waste Spills Contingency Plan for Emergency Transport Procedure for Containment
Treatment Method
Training for the activities that are carried out in our facility is outlined in Attachment A.
Our facility must maintain records of employee training. These records will be kept
(2)
Training records will be kept for participants in all training sessions for a minimum of three (3) years and will be available for review by Department of Health (DOH) inspectors. An example of an attendance record is appended in Attachment B.
IV. DEFINITION, IDENTIFICATION, AND SEGREGATION OF BIOMEDICAL WASTE Biomedical waste is any solid or liquid waste which may present a threat of infection
to humans. Biomedical waste is further defined in subsection 64E-16.002(2), F.A.C.
Items of sharps and non-sharps biomedical waste generated in this facility and the
locations at which they are generated are:
(3)
If biomedical waste is in a liquid or semi-solid form and aerosol formation is minimal, the waste may be disposed into a sanitary sewer system or into another system approved to receive such waste by the Department of Environmental Protection or the DOH.
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Red bags for containment of biomedical waste will comply with the required physical properties.
Our red bags are manufactured by
(4)
Our documentation of red bag construction standards is kept
(5)
Working staff can quickly get red bags at
(6)
Sharps will be placed into sharps containers at the point of origin.
Filled red bags and filled sharps containers will be sealed at the point of origin. Red bags, sharps containers, and outer containers of biomedical waste, when sealed, will not be reopened in this facility. Ruptured or leaking packages of biomedical waste will be placed into a larger container without disturbing the original seal.
VI. LABELING
All sealed biomedical waste red bags and sharps containers will be labeled with this facility’s name and address prior to offsite transport. If a sealed red bag or sharps container is placed into a larger red bag prior to transport, placing the facility’s name and address only on the exterior bag is sufficient.
Outer containers must be labeled with our transporter’s name, address, registration number, and 24-hour phone number.
VII. STORAGE
When sealed, red bags, sharps containers, and outer containers will be stored in areas that are restricted through the use of locks, signs, or location. The 30-day storage time period will commence when the first non-sharps item of biomedical waste is placed into a red bag or sharps container, or when a sharps container that contains only sharps is sealed.
Indoor biomedical waste storage areas will be constructed of smooth, easily cleanable materials that are impervious to liquids. These areas will be regularly maintained in a sanitary condition. The storage area will be vermin/insect free. Outdoor storage areas also will be conspicuously marked with a six-inch international biological hazard symbol and will be secure from vandalism.
Biomedical waste will be stored and restricted in the following manner:
(7)
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VIII. TRANSPORT
We will negotiate for the transport of biomedical waste only with a DOH-registered company. If we contract with such a company, we will have on file the pick-up receipts provided to us for the last three (3) years. Transport for our facility is provided by:
a.The following registered biomedical waste transporter: Company name (8)
Address
Phone
Registration number
Place pick-up receipts are kept
OR
b. An employee of this facility who works under the following guidelines:
We will transport our own biomedical waste. For tracking purposes, we will maintain a log of all biomedical waste transported by any employee for the last three (3) years. The log will contain waste amounts, dates, and documentation that the waste was accepted by a permitted facility. Name of employee(s) who is(are) assigned transport duty:
(9)
Biomedical waste will be transported to: (10)
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IX. PROCEDURE FOR DECONTAMINATING BIOMEDICAL WASTE SPILLS (11)
X.CONTINGENCY PLAN
If our registered biomedical waste transporter is unable to transport this facility’s biomedical waste, or if we are unable temporarily to treat our own waste, then the following registered biomedical waste transporter will be contacted:
Company name (12)
XI. BRANCH OFFICES
The personnel at our facility work at the following branch offices during the days and times indicated:
1)Office name (13) Office address (14)
Days of operation (15) Hours of operation (16)
2)Office name (13) Office address (14)
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XII. MISCELLANEOUS
For easy access by all of our staff, a copy of this biomedical waste operating plan will be kept in the following place:
(17)
The following items will be kept where indicated:
a.Current DOH biomedical waste permit/ exemption document (18)
b.Current copy of Chapter 64E-16, F.A.C. (19)
c.Copies of biomedical waste inspection reports from last three (3) years (20)
d.Transport log (21)
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Facility Name:
Trainer’s Name:
Outline:
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Filling out the Biomedical Waste Operating Plan form is a straightforward process that requires detailed knowledge about your facility's management of biomedical waste. It's essential to ensure that all information provided is accurate and compliant with Chapter 64E-16, Florida Administrative Code (F.A.C.), and Florida Statutes section 381.0098. Below are step-by-step instructions that will guide you through each section of the form.
Attachments A, B, and C require specific attention to detail. For Attachment A, include activities related to personnel training as outlined in Section III. In Attachment B, document the necessary information for training sessions. Attachment C should only be completed if your facility treats biomedical waste. If your facility either has its untreated biomedical waste removed by a registered transporter or transports its own untreated waste, this attachment should not be filled out.
The Biomedical Waste Operating Plan serves as a crucial guide for facilities in managing biomedical waste appropriately. It details the proper handling, segregation, storage, transport, and disposal procedures to avoid contamination and ensure public safety. This plan aligns with the regulations outlined in Chapter 64E-16, Florida Administrative Code (F.A.C.), and section 381.0098, Florida Statutes, fostering compliance with state laws.
Any facility that generates, handles, or disposes of biomedical waste within the state of Florida must develop and maintain a Biomedical Waste Operating Plan. This encompasses a wide range of facilities, including hospitals, clinics, dental practices, laboratories, and any other location where biomedical waste might be produced.
Personnel involved in the handling and management of biomedical waste must undergo specialized training to ensure compliance with the plan and state regulations. Training covers various critical areas, such as waste definition and identification, segregation, storage, labeling, transport procedures, and the proper method for decontaminating spills. Records of this training must be maintained for at least three years and be readily available for inspection.
Biomedical waste includes any solid or liquid waste that poses a threat of infection to humans. This encompasses items such as sharps, contaminated laboratory dishes, and discarded surgical gloves, among others. The plan provides detailed guidelines on how to identify and segregate biomedical waste within the facility.
The containment and storage of biomedical waste must be done in a manner that prevents exposure and contamination. Waste should be segregated at the point of generation and placed in compliant red bags or containers that are clearly labeled as biomedical waste. These containers must be stored in a designated, secure area that is easily cleanable and away from public access until they are ready for disposal or transport.
Biomedical waste containers must be labeled with the universal biohazard symbol and the word "biohazard" to clearly indicate their contents. This labeling is essential for the safety of personnel handling the waste and for compliance with state regulations.
In the event of a spill involving biomedical waste, facilities must follow a specific decontamination process to mitigate risks. This includes the use of appropriate protective equipment, the application of disinfectants, and the safe removal of contaminated materials. The operating plan outlines the products and procedures that should be used for effective decontamination.
The operating plan must include a contingency plan for situations where the regular transport of biomedical waste is disrupted. This plan details alternative measures and contacts for emergency transport to ensure the waste is handled safely and in accordance with regulations.
Facilities must keep a copy of their Biomedical Waste Operating Plan, current biomedical waste permit or exemption document, a copy of the biomedical waste rules, and records of inspections and employee training within easy access for review. This documentation is essential for verifying compliance during inspections by health authorities.
When filling out the Biomedical Waste Operating Plan form, some common mistakes can hinder compliance and efficiency in handling biomedical waste. Awareness and corrective measures for these errors ensure that facilities manage biomedical waste safely and in line with regulatory requirements:
Omitting to specify the exact locations where different types of biomedical waste are generated (Blank 3). Identifying these locations is crucial for effective waste segregation and management.
Not verifying that the red bags used for biomedical waste disposal are approved by the Department of Health or meet the construction requirements specified in Chapter 64E-16, F.A.C. (Blank 4). This oversight can lead to the use of substandard bags, risking exposure and non-compliance.
Failing to properly document where the construction standards for red bags are kept or if applicable, not indicating N/A when red bags are not used (Blank 5). Accurate record-keeping supports compliance during inspections.
Incomplete details about the storage area for biomedical waste, particularly how the area is washable, out of client traffic, and how access is restricted (Blank 7). These details are necessary to ensure that the storage of biomedical waste does not pose a risk to staff and visitors.
Not providing comprehensive information about the registered biomedical waste transporter, especially if the facility relies on external services for waste removal (Blank 8). This information is critical for tracking and verifying the lawful disposal of waste.
Overlooking the need to describe the procedure and products used for decontaminating spills or leaks of biomedical waste (Blank 11). Having a clear and accessible procedure is vital for the quick and safe response to spills.
In addressing these mistakes, facilities can enhance the safety, efficiency, and compliance of their biomedical waste management practices. Documents should be reviewed carefully, and all relevant information must be provided accurately and thoroughly:
In conjunction with a Biomedical Waste Operating Plan, several other documents and forms play critical roles in ensuring the efficient, lawful, and safe handling of biomedical waste. These documents not only facilitate compliance with regulations but also streamline internal processes regarding the management of biomedical waste within healthcare facilities, laboratories, and other related entities.
Each of these documents supports the overarching goal of the Biomedical Waste Operating Plan: to manage biomedical waste responsibly to protect the health and safety of workers, patients, and the community at large. Proper documentation not only serves as evidence of compliance with regulatory standards but also as a blueprint for effective waste management practices. Ensuring that these forms and documents are correctly filled out, regularly updated, and readily available is essential for any facility generating or handling biomedical waste.
The Hazard Communication Plan shares similarities because it also involves outlining procedures for handling hazardous materials, including proper labeling, storage, and employee training, paralleling the management and communication requirements for biomedical waste.
A Chemical Hygiene Plan is similar in that it promotes safe practices for handling chemicals in laboratories, including aspects of waste management, handling spill responses, and protective measures for personnel, aspects that are also addressed for biomedical waste.
The Infection Control Plan outlines measures to prevent the spread of infections within healthcare facilities, including the handling and disposal of infectious waste, reflecting the purpose of the Biomedical Waste Operating Plan in mitigating infection risks associated with waste.
An Emergency Response Plan is designed to guide actions during emergencies, including hazardous material spills, which aligns with the contingency and decontamination procedures for biomedical waste spills mentioned in the operating plan.
A Fire Safety Plan might seem less related, yet it includes elements of how to deal with emergencies involving hazardous materials, which could encompass biomedical waste, emphasizing proper storage and labeling to prevent accidents.
The Personal Protective Equipment (PPE) Program documents the selection and use of PPE to protect employees from hazards, similar to the training component in the Biomedical Waste Operating Plan that emphasizes personal safety from hazardous biomedical waste.
A Spill Prevention, Control, and Countermeasure (SPCC) Plan is pertinent mainly to oil and hazardous substances, yet it embodies principles of preventing and responding to spills that are applicable in the management of biomedical waste, focusing on preventing environmental contamination.
When filling out the Biomedical Waste Operating Plan form, it is important to handle the process with care to ensure compliance with regulations and to safeguard public health. Below are key dos and don'ts that facilities should follow:
Things You Should Do:
Things You Shouldn't Do:
Many healthcare facilities and related institutions need to complete a Biomedical Waste Operating Plan form. However, there are several misconceptions about this form and its requirements. Understanding these misconceptions is essential for proper compliance and management of biomedical waste.
Understanding these misconceptions is crucial for healthcare facilities to manage biomedical waste properly and comply with state regulations. By accurately completing the Biomedical Waste Operating Plan form and following its guidelines, facilities can ensure the safe and effective disposal of biomedical waste, protecting the health of employees, patients, and the public.
When completing the Biomedical Waste Operating Plan form, facilities must provide specific details including their name, training record locations, types and origins of biomedical waste produced, and storage and transportation arrangements. This ensures compliance with Chapter 64E-16, F.A.C., addressing proper biomedical waste management.
It is essential for facilities to use red bags that meet the Department of Health's construction requirements for biomedical waste containment. These requirements can be verified by checking the DOH list or obtaining independent laboratory results from the bag manufacturer.
Facilities must document where red bags and other containment solutions are stored within their operational areas to ensure staff can access them quickly as needed. This reduces the chance of improper waste handling and increases overall safety.
Biomedical waste storage areas must be washable, located away from client traffic, and have restricted access to ensure safety and compliance with regulations. These specifications help in minimizing the risk of exposure and contamination.
The choice of a registered biomedical waste transporter is crucial for the legal and safe disposal of waste. Facilities must provide detailed information about their transporter(s) or document their procedure for transporting their biomedical waste if they manage transportation internally.
Decontamination procedures for spills or leaks are a mandatory part of the operating plan. Facilities must outline specific methods and products used for efficient and safe cleanup of biomedical waste spills.
In case of emergencies, having a contingency plan with information about an alternative registered biomedical waste transporter ensures that waste can still be managed and disposed of properly, preventing any risk to public health and safety.
Training for personnel in managing biomedical waste is not just an optional extra; it's a legal requirement. The facility must conduct training sessions covering all relevant aspects of biomedical waste handling, as outlined in Attachment A, and keep meticulous records for at least three years.
Finally, facilities are encouraged to keep their Biomedical Waste Operating Plan, current biomedical waste permit or exemption documents, and a copy of Chapter 64E-16, F.A.C. accessible within the facility. This prepares the facility to respond to inspections and ensures ongoing compliance with regulations.
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