The Biomedical Waste Operating Plan form is a critical document designed to guide facilities in the responsible management of biomedical waste, in compliance with Chapter 64E-16, Florida Administrative Code (F.A.C.), and section 381.0098, Florida Statutes. It encompasses a wide array of procedures, including waste identification, segregation, containment, labeling, storage, transport, and the mandatory training for personnel involved in these processes. To ensure your facility meets state requirements and prioritizes public health safety, clicking the button below to fill out and submit your Biomedical Waste Operating Plan is essential.
The Biomedical Waste Operating Plan form, revised on October 5, 2005, is an essential document for facilities managing biomedical waste, ensuring they adhere to the guidelines and requirements set forth in Chapter 64E-16, Florida Administrative Code (F.A.C.), and section 381.0098, Florida Statutes. It encapsulates several critical elements such as the purpose of the plan, detailed instructions for completing it, and valuable resources like website links for further assistance. The form provides a comprehensive outline for documenting a facility's management strategies across various aspects including the definition, identification, and segregation of biomedical waste; training for personnel; containment, labeling, and storage procedures; transport logistics; and protocols for decontaminating spills. Furthermore, it addresses the contingency plans for emergency situations and the required documentation such as training attendance records and the treatment of biomedical waste if applicable. Notably, the packet underscores the importance of maintaining accurate records and compliance, offering sample documents and a template for creating an operational plan tailored to a facility's specific needs. These components collectively aid facilities in establishing rigorous waste management practices to mitigate risks and maintain public health and safety standards.
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.
Page 4 of 27
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 crucial step for facilities managing biomedical waste. This guide makes the process clear and manageable, ensuring that you comply with regulations while promoting a safe and healthy environment. Let's go through the necessary steps together, breaking them down into manageable parts.
By following these steps, you'll effectively complete your Biomedical Waste Operating Plan. This process ensures your facility's compliance with health and safety standards while protecting both the environment and community health.
What is the purpose of a Biomedical Waste Operating Plan?
The purpose of a Biomedical Waste Operating Plan is to provide a facility with guidelines and requirements for handling, storing, and disposing of biomedical waste in a manner that prevents the spread of infection and protects human health. This plan is based on regulations outlined in Chapter 64E-16, Florida Administrative Code (F.A.C.), and section 381.0098, Florida Statutes, aimed at ensuring safe biomedical waste management practices.
How often do facilities need to train their personnel on biomedical waste procedures?
Facilities are required to conduct biomedical waste training for their personnel periodically, as mandated by paragraph 64E-16.003(2)(a), F.A.C. This training covers compliance with the facility's operating plan and Chapter 64E-16, F.A.C. It includes topics such as the definition and identification of biomedical waste, proper segregation, storage, labeling, transport, decontamination procedures for spills, and contingency plans for emergencies. Records of these training sessions must be maintained for at least three years and be readily available for review by Department of Health inspectors.
What are the requirements for biomedical waste bags?
Facilities that use red bags for biomedical waste must ensure these bags are listed by the Department of Health (DOH) or have certification from independent laboratory tests indicating they meet construction requirements specified in Chapter 64E-16, F.A.C. The name of the bag manufacturer, documentation for the bag's construction standards, and storage locations for both used and unused bags within the facility must be clearly stated in the Biomedical Waste Operating Plan. If a facility does not use red bags for biomedical waste, this should also be noted in their operating plan.
What should a facility do if it does not have a storage area for biomedical waste?
If a facility does not have a designated storage area for biomedical waste due to the immediate pickup by a licensed transporter, the plan must detail procedures for preparing biomedical waste for pickup. This includes how the waste is contained and labeled prior to pickup. If the facility does not proceed with any pickups or storage, indicating "N/A" (not applicable) in the storage section of the operating plan is required. In all cases, ensuring the safe and compliant handling of biomedical waste until it is transported off-site is crucial.
Not confirming if the manufacturer of the red bags is on the Department of Health's approved list. For accuracy, the manufacturer’s name should match the list available from the DOH or the facility must have independent lab results confirming compliance.
Failure to specify the exact storage location for unused, red biomedical waste bags in operational areas. This detail helps ensure that staff can quickly access new bags when needed.
Omitting the description of how the biomedical waste storage area is washable, out of client traffic, and how access to it is restricted. This information is crucial for maintaining safety and compliance.
Incorrectly listing or not listing the registered biomedical waste transporter. This information is vital for compliance and ensuring the safe and legal disposal of biomedical waste.
Not providing the name(s) of the employee(s) designated to transport untreated biomedical waste, if applicable. This oversight can lead to confusion and compliance issues.
Skip adding information about the procedure and products used to decontaminate spills or leaks of biomedical waste. Knowing the proper procedure is essential for handling emergencies safely.
Leaving blank or incorrectly filling out information regarding the contingency biomedical waste transporter. This detail is critical for a backup plan in case the primary method of disposal is unavailable.
Forgetting to indicate where the current biomedical waste permit or exemption document is kept. This document should be readily accessible for inspection.
Not specifying where the facility keeps its current copy of the biomedical waste rules, Chapter 64E-16, F.A.C. Access to these rules is necessary for maintaining compliance.
Failing to maintain and indicate where training records of employee biomedical waste handling sessions are kept for at least three years. These records are important for proving compliance during inspections.
When managing biomedical waste, it's crucial to understand and properly implement the processes outlined in the Biomedical Waste Operating Plan. However, this is just one component of a comprehensive compliance framework. To ensure the safe and lawful handling, treatment, and disposal of biomedical waste, several additional forms and documents are often used alongside the Biomedical Waste Operating Plan. Each plays a vital role in safeguarding public health, employee safety, and environmental protection.
By incorporating these documents and forms into their operational procedures, facilities can maintain a comprehensive biomedical waste management program. This not only ensures compliance with regulatory requirements but also protects the health and safety of employees, patients, the community, and the environment. The seamless integration of these documents with the Biomedical Waste Operating Plan forms a robust framework for the effective management of biomedical waste.
Hazardous Materials Response Plan: Similar to the Biomedical Waste Operating Plan, a Hazardous Materials Response Plan outlines procedures for handling hazardous substances, including identification, containment, and disposal. Both plans aim to protect health and the environment by detailing specific actions to manage potentially dangerous materials safely.
Infection Control Plan: This document is designed for settings like hospitals and clinics to prevent the spread of infections. It shares similarities with the biomedical waste plan through its focus on training, procedures for dealing with spills (in this case, biological spills), and waste management to minimize infection risks.
Chemical Hygiene Plan: Used primarily in laboratories, this plan outlines the safe use, storage, and disposal of chemicals. It parallels the biomedical waste plan in emphasizing proper segregation, containment, and emergency procedures for handling spills to ensure worker safety and environmental protection.
Environmental Management System (EMS) Documentation: An EMS encompasses plans, procedures, and policies for managing an organization's environmental impacts. The component of handling hazardous waste within an EMS can be very similar to the Biomedical Waste Operating Plan, focusing on reducing environmental harm through meticulous waste management practices.
Safety Data Sheets (SDS): Although typically a collection of documents rather than a single plan, SDS provide detailed information on handling, storing, and disposing of chemical products safely. They are similar to the biomedical waste plan in offering specific instructions designed to protect users and the environment from harm.
Emergency Response Plan: This document details actions to take during emergencies, including those that may involve biomedical waste spills. Like the Biomedical Waste Operating Plan, it focuses on ensuring that proper steps are followed to contain and mitigate risks promptly.
Occupational Health and Safety Plan: Aimed at protecting employees from workplace hazards, these plans often include sections on hazardous waste management similar to practices found in the biomedical waste plan, especially concerning training, proper equipment use, and emergency procedures.
Waste Management Plan: General waste management plans cover the segregation, collection, storage, transport, and disposal of various waste types. The segment concerning hazardous waste management closely aligns with the methods and objectives outlined in the Biomedical Waste Operating Plan.
Spill Prevention, Control, and Countermeasure (SPCC) Plan: SPCC plans are essential for facilities that use or store oil and oil products to prevent spills into navigable waters or shorelines. There is a similarity in the emphasis on preventive measures, containment methods, and response actions including training and preparedness, akin to those in the biomedical waste plan.
Incident and Accident Reporting Procedures: While more generic, these procedures ensure that any incidents, especially those involving hazardous materials or wastes, are properly reported and documented. The emphasis on documentation and response is consistent with the approach taken in the Biomedical Waste Operating Plan, underscoring the importance of accountability and mitigation of harm.
When completing the Biomedical Waste Operating Plan form, it is crucial to follow specific guidelines to ensure compliance with regulations and maintain a safe environment. Here are seven things you should and shouldn't do:
By adhering to these dos and don'ts, you will ensure that your Biomedical Waste Operating Plan is thoroughly and accurately completed, maintaining compliance with regulations and protecting the health and safety of your facility's environment.
Many misconceptions surround the Biomedical Waste Operating Plan form, leading to confusion and potentially non-compliance issues among the facilities required to manage biomedical waste. Clarifying these misconceptions is essential for ensuring that these facilities comply with legal requirements and maintain a safe environment for staff, clients, and the public. Below are eight common misconceptions and the truths behind them:
The Biomedical Waste Operating Plan is mandatory for all healthcare facilities. This is incorrect. The use of the plan format provided by the Department of Health (DOH) is voluntary, not mandatory. It is intended as a resource to aid facilities in complying with Chapter 64E-16, Florida Administrative Code (F.A.C.), concerning the management of biomedical waste.
Completing the form is a complex and technical process. Actually, the form is designed to be user-friendly, including clear directions for completing each section. The main goal is to assist facilities in documenting their compliance with the relevant regulations in an organized manner.
Every facility must use red bags for biomedical waste. This is a misunderstanding. While red bags are commonly used and are a standard for containing certain types of biomedical waste, the crucial factor is that the bags meet the construction requirements set out in Chapter 64E-16, F.A.C. Facilities have the option to use alternative solutions, provided they are approved and meet the necessary standards.
All biomedical waste must be treated on-site. Not true. Facilities have options for the treatment of biomedical waste. It can be treated on-site if the facility has the capability and appropriate permits, or it can be removed by a registered biomedical waste transporter for off-site treatment.
There is no need for a contingency plan. Incorrect. The Biomedical Waste Operating Plan requires facilities to have a contingency plan for emergency transport of biomedical waste, ensuring that there is a defined process in place should the primary method of waste management fail or be unavailable.
Branch offices do not need to follow the main facility's plan. This is a misconception. If personnel from the main facility also work at a branch office, the branch office is required to follow the Biomedical Waste Operating Plan of the main facility to ensure consistent and safe waste management practices across all locations.
Training on biomedical waste management is a one-time requirement. This is incorrect. Training for personnel is an ongoing requirement, with initial training and regular updates to ensure compliance with current regulations and standards. Facilities must maintain training records for a minimum of three years, available for review by DOH inspectors.
Facilities can dispose of biomedical waste in regular trash as long as it's bagged properly. Absolutely false. Biomedical waste must be segregated, contained, and disposed of according to strict regulations to prevent the risk of infection and environmental contamination. Proper disposal often involves containment in approved containers or bags and removal by licensed biomedical waste transporters for treatment at approved facilities.
Understanding the requirements and dispelling these misconceptions is vital for facilities handling biomedical waste. Compliance ensures not only legal adherence but also the safety and well-being of everyone involved.
Understanding the Biomedical Waste Operating Plan form is crucial for facilities that handle biomedical waste. This form helps ensure that biomedical waste is managed correctly, safeguarding public health and the environment. Here are six key takeaways:
Adhering to the guidelines and requirements outlined in the Biomedical Waste Operating Plan form is essential for the proper management of biomedical waste. It helps protect the health of employees, patients, and the community while ensuring compliance with state regulations.
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