The Biomedical Waste Operating Plan form serves as a critical tool for facilities managing biomedical waste, guiding them in proper handling, segregation, and disposal practices to ensure environmental and public safety. This comprehensive document, grounded in the stringent requirements of Chapter 64E-16, Florida Administrative Code (F.A.C.), and further supported by the Florida Department of Health, offers a detailed framework from training personnel to emergency spill procedures. It is instrumental for facilities to maintain compliance with state regulations and safeguard human health against the risks associated with the improper management of biomedical waste.
Managing biomedical waste is a critical responsibility for healthcare facilities to ensure the safety of both the public and the environment. The Biomedical Waste Operating Plan form serves as a comprehensive guide for achieving this objective. Revised on October 5, 2005, and provided by the Manatee County Health Department, this form not only lays out the steps necessary for the proper handling, segregation, containment, storage, and transport of biomedical waste but also includes protocols for decontaminating waste spills, thereby minimizing potential risks. Moreover, it emphasizes the importance of training for personnel in effectively managing biomedical waste, in compliance with Chapter 64E-16 of the Florida Administrative Code (FAC) and section 381.0098 of the Florida Statutes. Through detailed instructions, recommended procedures, valuable website resources, and specific templates such as training outlines and attendance records, the form aids facilities in adhering to the legal requirements and maintaining a safe healthcare environment. It is designed to assist in the preparation of a facility-specific operating plan that meets the standards set forth by the Florida Department of Health, although its usage is voluntary. Such thorough documentation underscores the commitment to maintaining public health standards and environmental safety through diligent biomedical waste management.
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:
Page 10 of 27
Successfully completing a Biomedical Waste Operating Plan form is a vital step in ensuring the safe and responsible handling of biomedical waste. This action not only contributes to the environmental health service's compliance with legal standards but also safeguards public health by managing potential hazards. The guide below breaks down the process into clear, manageable steps, making it easier for facilities to comply with Chapter 64E-16, Florida Administrative Code (F.A.C.), and section 381.0098, Florida Statutes.
After completing these steps, carefully review the entire form to ensure accuracy and completeness. Submitting a precise and thorough Biomedical Waste Operating Plan not only ensures compliance with regulatory standards but also significantly contributes to public health and safety by preventing potential hazards associated with the improper handling of biomedical waste.
What is a Biomedical Waste Operating Plan?
A Biomedical Waste Operating Plan is a document that outlines the procedures and requirements for the proper management of biomedical waste within a facility. This includes guidelines for the definition, identification, segregation, containment, labeling, storage, transport, and decontamination of biomedical waste spills. The plan is designed to ensure compliance with Chapter 64E-16, Florida Administrative Code (F.A.C.), and section 381.0098, Florida Statutes, to protect human health and the environment.
Who needs to complete the Biomedical Waste Operating Plan?
Any facility that generates, handles, stores, or disposes of biomedical waste within the state of Florida is required to complete and maintain a Biomedical Waste Operating Plan. This includes, but is not limited to, hospitals, clinics, nursing homes, laboratories, dental and veterinary offices, and any other facility generating biomedical waste.
What information is required in the plan?
The plan must include detailed information about the facility, such as the facility name, location of employee training records, and descriptions of biomedical waste generated. It must also document containment methods, the manufacturer of red bags used for waste (if applicable), storage and transport arrangements, procedures for decontaminating biomedical waste spills, and a contingency plan, among others.
Is training required for personnel handling biomedical waste?
Yes, training is mandatory for all personnel involved in the handling, treatment, storage, or disposal of biomedical waste. Training sessions must cover compliance with the operating plan and Chapter 64E-16, F.A.C., including all relevant activities such as waste identification and segregation, proper containment, and spill decontamination procedures. The facility must maintain records of employee training for at least three years, available for review by Department of Health inspectors.
How often should the Biomedical Waste Operating Plan be updated?
The plan should be reviewed and updated regularly to ensure it accurately reflects current practices and complies with any changes in regulations. It is recommended to review the plan annually or whenever significant changes occur within the facility that could affect the management of biomedical waste.
Where should the Biomedical Waste Operating Plan be kept?
The operating plan should be kept in an easily accessible location within the facility and made available to all employees involved in the handling of biomedical waste. It must also be presented to Department of Health inspectors upon request.
What happens if a facility does not have a Biomedical Waste Operating Plan?
A facility that fails to develop and maintain a Biomedical Waste Operating Plan is in violation of state regulations and may be subject to penalties, fines, or other enforcement actions by the Florida Department of Health. Compliance is essential to ensure the safe and effective management of biomedical waste and protect public health and the environment.
Can a facility use its own format for the Biomedical Waste Operating Plan?
While the use of the provided plan format is voluntary and not mandated by the Department of Health, it is designed to assist facilities in complying with the requirements of Chapter 64E-16, F.A.C. Facilities are at liberty to develop their own plan format, provided it covers all necessary elements and complies with state regulations regarding biomedical waste management.
When completing the Biomedical Waste Operating Plan form, individuals often overlook key details that can lead to errors in compliance. Identifying and understanding these common mistakes can significantly enhance the efficiency and safety of waste management processes in medical facilities.
One of the first mistakes lies in not specifying the location of employee training records (Blank 2). Documentation is crucial for accountability and ensuring all personnel are up-to-date with necessary training. Keeping these records in a consistent, known location facilitates smooth inspections and verifies compliance.
Another common error is the improper identification and listing of biomedical waste items (Blank 3). It’s vital that every item of waste generated at the facility is accounted for. This includes specifying the location where each type is produced. Accurate identification helps in the proper handling and disposal of different waste types, minimizing risks to staff and the public.
Often, facilities fail to verify the compliance of their red bag manufacturer (Blank 4). Using bags not approved by the Department of Health or lacking laboratory results validating their construction can lead to the use of substandard containment materials, risking breaches and contamination.
A deficiency frequently seen is in detailing the storage location and conditions of biomedical waste (Blank 7). The area designated for waste storage must be properly described, ensuring it is washable, away from client traffic, and access-restricted. This minimizes infection risks and ensures a safe environment for both clients and staff.
For facilities that transport their own waste, the omission of designated employee information (Blank 9) and the receiving facility’s details (Blank 10) is another mistake. This information ensures a clear understanding of responsibilities and the correct destination for waste, essential for tracking and accountability.
The plan for handling biomedical waste spills (Blank 11) is sometimes inadequately detailed. Specifying the procedure and products used for decontamination is crucial for effective response to accidents, protecting workers and the environment from exposure to hazardous materials.
Finally, a significant oversight is not indicating where the operating plan is stored within the facility (Blank 17). Accessibility to the plan ensures all staff are aware of the procedures and can refer to it when needed, promoting consistent practices and compliance with health regulations.
Addressing these common errors can significantly impact the safety and efficiency of biomedical waste management, ensuring both compliance with regulations and protection of public health.
When managing biomedical waste, the Biomedical Waste Operating Plan plays a vital role in ensuring public safety and compliance with the law. However, to fully comply with regulatory requirements and guarantee the safety of both the staff and the broader public, several other forms and documents are often used in conjunction with this operating plan. Let's explore some of these essential documents that facilitate comprehensive biomedical waste management.
In addition to the Biomedical Waste Operating Plan, these forms and documents collectively ensure that biomedical waste is handled with the utmost care throughout its lifecycle — from generation and segregation to treatment and final disposal. This comprehensive approach not only fulfills legal obligations but also safeguards public health and the environment against the potential hazards of improperly managed biomedical waste.
One document that closely mirrors the Biomedical Waste Operating Plan is the Hazardous Materials Business Plan (HMBP). This document outlines the handling, storage, and disposal of hazardous materials to ensure public safety and environmental protection. Both plans require detailed descriptions of the materials, including where they are stored and how they are segregated, and emphasize the importance of training for employees involved in handling the materials. The HMBP, similar to the Biomedical Waste Operating Plan, necessitates an emergency response plan for potential accidents.
The Chemical Hygiene Plan (CHP) shares similarities with the Biomedical Waste Operating Plan, as it outlines safety procedures and protocols for handling chemicals in laboratories. Both documents necessitate identifying hazardous materials, training employees, and establishing emergency response protocols. The CHP focuses on chemical exposure prevention, while the Biomedical Waste Operating Plan is geared towards managing biohazardous waste, both aiming to protect personnel and the environment.
The Infectious Disease Preparedness and Response Plan is another document akin to the Biomedical Waste Operating Plan. It includes protocols for managing and minimizing the spread of infectious diseases within an organization. Both plans require training for staff, proper waste segregation, and emergency procedures. The main focus is ensuring the health and safety of both employees and the public by preventing exposure to infectious agents or hazardous materials.
The Environmental Protection Plan (EPP) also parallels the Biomedical Waste Operating Plan in its objective to prevent environmental contamination. The EPP encompasses broader environmental considerations, including waste management, soil and water protection, and air quality. While the EPP covers a wider range of environmental issues, both documents highlight the importance of proper waste handling procedures and emergency response plans to mitigate their respective impacts on the environment.
The Laboratory Safety Manual can be considered similar to the Biomedical Waste Operating Plan since it addresses the safe handling and disposal of hazardous materials in a lab setting. Both documents emphasize the importance of training, correct waste segregation, and spill management procedures to ensure the safety of laboratory personnel and the surrounding environment.
An Emergency Action Plan (EAP) also shares characteristics with the Biomedical Waste Operating Plan. The EAP focuses on employee safety during emergencies, such as fires or hazardous material spills. Both plans require clear procedures for responding to such incidents, including evacuation routes, communication strategies, and employee roles and responsibilities, underlining the priority of human health and safety.
The Waste Management Plan (WMP), much like the Biomedical Waste Operating Plan, outlines the process for handling various types of waste generated by a facility. It describes segregation, storage, transport, and disposal methods. Although the WMP may cover a broader spectrum of waste types, both documents focus on minimizing environmental impact and ensuring compliance with regulations.
The Occupational Health and Safety Plan (OHSP) is designed to protect employees from workplace hazards, which encompasses the handling of biomedical waste as a component of broader safety measures. Like the Biomedical Waste Operating Plan, it addresses training, personal protective equipment, and emergency procedures, reinforcing the safeguarding of employee health and safety.
The Spill Prevention, Control, and Countermeasure (SPCC) Plan shares a common goal with the Biomedical Waste Operating Plan in preventing pollution caused by spills. Although the SPCC Plan mainly targets oil and fuel spills, both plans include detailed procedures for immediate response to spills, employee training, and preventive measures to avoid environmental contamination.
Lastly, the Radiation Safety Manual, while focused on the management of radioactive materials, resembles the Biomedical Waste Operating Plan in its approach to safety and compliance. It mandates rigorous training for personnel, stringent waste handling procedures, and effective response strategies for accidents, aligning with the overarching goal of protecting people and the environment from hazardous substances.
When completing the Biomedical Waste Operating Plan form, it's essential to adhere to guidelines ensuring accurate and responsible handling of biomedical waste. Here are nine critical do's and don'ts:
Following these directives facilitates compliance with Chapter 64E-16, Florida Administrative Code (F.A.C.), and helps ensure the safety and health of both facility personnel and the broader community. Proper management of biomedical waste is not just a regulatory requirement but a public health imperative.
There are several misconceptions surrounding the Biomedical Waste Operating Plan form which may lead to confusion or incorrect compliance. Here are seven common misunderstandings and the realities behind them:
Understanding these aspects of the Biomedical Waste Operating Plan is critical for facilities to manage biomedical waste safely and in compliance with the Florida Administrative Code.
When completing and implementing the Biomedical Waste Operating Plan, it's crucial to ensure all information is accurate and comprehensive. This will facilitate proper biomedical waste management and compliance with Chapter 64E-16, F.A.C., ensuring a safe environment for both employees and the public. Here are six key takeaways from the Biomedical Waste Operating Plan document:
Adhering to these key points when filling out and utilizing the Biomedical Waste Operating Plan will help ensure that biomedical waste is managed correctly and in compliance with Florida's health and safety regulations. Proper management of biomedical waste not only protects health but also helps preserve the environment.
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