Article Guide
The Biomedical Waste Operating Plan form serves as a crucial tool for facilities managing biomedical waste, ensuring compliance with health regulations while promoting safety and environmental protection. This comprehensive packet includes a sample operating plan, complete with instructions and valuable resources to guide facilities through the complexities of biomedical waste management. Among its key components are recommended procedures for decontaminating spills, a detailed training outline for personnel, and essential information on labeling, storage, and transportation of biomedical waste. The form also emphasizes the importance of proper segregation and containment of biomedical waste, which is defined as any waste that poses an infection risk to humans. Additionally, the plan outlines the necessary steps for maintaining documentation, including training records and inspection logs, to ensure ongoing compliance with Chapter 64E-16 of the Florida Administrative Code. By following the guidelines laid out in this form, facilities can effectively manage their biomedical waste, safeguarding both public health and the environment.
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Jeb Bush |
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M. Rony François, M.D., M.S.P.H., Ph.D. |
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Governor |
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Secretary |
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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
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
Manatee County Health Department
ENVIRONMENTAL HEALTH SERVICES
410Sixth Avenue East • Bradenton
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
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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
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
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
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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II.PURPOSE
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
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
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
Items of sharps and
locations at which they are generated are:
(3)
If biomedical waste is in a liquid or
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V.CONTAINMENT
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
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
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
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
a.The following registered biomedical waste transporter: Company name (8)
Address
Phone
Registration number
Place
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)
Address
Phone
Registration number
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)
Days of operation (15) Hours of operation (16)
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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
c.Copies of biomedical waste inspection reports from last three (3) years (20)
d.Transport log (21)
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ATTACHMENT A: BIOMEDICAL WASTE TRAINING OUTLINE
Facility Name:
Trainer’s Name:
Outline:
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Form Specifications
| Fact Name | Fact Description |
|---|---|
| Governing Law | The Biomedical Waste Operating Plan is governed by Chapter 64E-16 of the Florida Administrative Code (FAC) and section 381.0098 of the Florida Statutes. |
| Voluntary Use | Using this plan format is voluntary. It serves as a helpful guide for facilities managing biomedical waste. |
| Training Requirements | Facilities must provide training for personnel on biomedical waste management, as mandated by paragraph 64E-16.003(2)(a), F.A.C. |
| Record Keeping | Training records must be maintained for at least three years and should be accessible for review by Department of Health inspectors. |
| Spill Management | The plan includes procedures for decontaminating biomedical waste spills, ensuring safety and compliance. |
| Waste Segregation | Facilities are required to define, identify, and segregate biomedical waste to minimize infection risks. |
| Storage Guidelines | Biomedical waste must be stored in a designated area that is washable and restricted from client traffic. |
| Transport Protocols | Details about the registered biomedical waste transporter must be documented, including their compliance with state regulations. |
| Attachments | The plan includes attachments for training outlines, attendance records, and additional treatment plans for biomedical waste. |
Biomedical Waste Operating Plan: Usage Guidelines
Completing the Biomedical Waste Operating Plan form is an essential step for ensuring your facility complies with regulations regarding biomedical waste management. Follow these steps carefully to fill out the form accurately.
- Enter your facility name in Blank 1.
- Provide the location where you keep employee training records in Blank 2.
- List the types of biomedical waste produced in your facility and their generation locations in Blank 3.
- Enter the manufacturer’s name of your facility’s red bags in Blank 4. Ensure this company is compliant with the Department of Health list.
- Indicate where documentation for the construction standards of red bags is kept in Blank 5 or enter N/A if not applicable.
- Specify the location of unused red biomedical waste bags in Blank 6, or enter N/A if not applicable.
- Describe the storage area for biomedical waste in Blank 7, addressing its washability, traffic area restrictions, and access limitations. If there’s no storage area, indicate your procedure for waste pick-up.
- Enter the required information about your registered biomedical waste transporter in Blank 8, or enter N/A if not applicable.
- List the name(s) of employees designated to transport untreated biomedical waste in Blank 9, or enter N/A if not applicable.
- Specify the facility name where untreated biomedical waste is transported in Blank 10, or enter N/A if not applicable.
- Describe the decontamination procedure for spills in Blank 11.
- Provide information about the contingency transporter in Blank 12.
- Enter the name of any branch office in Blank 13, or enter N/A if not applicable.
- Provide the address of the branch office in Blank 14, or enter N/A if not applicable.
- List the weekdays the branch office is open in Blank 15, or enter N/A if not applicable.
- Specify the normal work hours for the branch office in Blank 16, or enter N/A if not applicable.
- Indicate where a copy of the operating plan will be kept in Blank 17.
- Specify where the current biomedical waste permit will be stored in Blank 18.
- Indicate where copies of the biomedical waste rules will be kept in Blank 19.
- Specify where copies of the last three years of inspections will be stored in Blank 20.
- Indicate where the transport log is kept if your facility transports its own biomedical waste in Blank 21, or enter N/A if not applicable.
Once you have completed the form, review it for accuracy and completeness. Ensure all necessary documentation is attached, and store the plan in a designated location for easy access by staff and health inspectors.
Your Questions, Answered
1. What is the purpose of the Biomedical Waste Operating Plan?
The Biomedical Waste Operating Plan provides guidance on the proper management of biomedical waste within a facility. It outlines the requirements set forth in Chapter 64E-16 of the Florida Administrative Code and section 381.0098 of the Florida Statutes. This plan aims to ensure that biomedical waste is handled safely and in compliance with state regulations.
2. Who needs to complete the Biomedical Waste Operating Plan?
Any facility that generates biomedical waste must complete the Biomedical Waste Operating Plan. This includes hospitals, clinics, laboratories, and any other establishments that handle materials that may pose a risk of infection to humans. The plan is voluntary but serves as a useful tool for compliance with state regulations.
3. What types of training are required for personnel?
Personnel must receive training on the definition and identification of biomedical waste, segregation, storage, labeling, transport, and procedures for decontaminating biomedical waste spills. Training sessions must be scheduled as required and records of attendance should be maintained for a minimum of three years for review by Department of Health inspectors.
4. How should biomedical waste be stored?
Biomedical waste should be stored in a designated area that is washable, out of client traffic areas, and has restricted access. Facilities must indicate where biomedical waste is stored and ensure that it is kept in compliance with safety standards. If a facility does not have a storage area, it should describe the procedure for preparing waste for pick-up by a licensed transporter.
5. What information is required about the biomedical waste transporter?
Facilities must provide information about their registered biomedical waste transporter, including the transporter's name and contact details. If a facility does not use a transporter, they should indicate this in the plan. The list of registered transporters can be found on the Florida Department of Health's website.
6. What should be included in the decontamination procedure for spills?
The decontamination procedure must describe the methods and products used to clean up any spills or leaks of biomedical waste. This includes specifying the cleaning agents and techniques that will be employed to ensure safety and compliance with health regulations.
7. How can facilities ensure compliance with the Biomedical Waste Operating Plan?
Facilities can ensure compliance by regularly reviewing and updating their Biomedical Waste Operating Plan, conducting required training sessions, and maintaining accurate records. They should also familiarize themselves with the relevant regulations and ensure that all staff are aware of their responsibilities regarding biomedical waste management.
8. Where can I find more information about biomedical waste regulations?
Additional information about biomedical waste regulations can be found in Chapter 64E-16 of the Florida Administrative Code and on the Florida Department of Health's website. The site provides resources, including lists of compliant red bag manufacturers and registered biomedical waste transporters.
Common mistakes
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Incomplete Facility Information: Failing to provide the complete name of the facility can lead to confusion and delays in processing the plan.
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Incorrect Waste Item Listing: Listing biomedical waste items inaccurately or omitting them entirely can result in non-compliance with regulations.
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Missing Documentation: Not including the required documentation for red bag manufacturers can lead to issues with waste containment standards.
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Improper Storage Details: Neglecting to specify how the biomedical waste storage area is restricted and accessible can create safety hazards.
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Failure to Update Training Records: Not maintaining current training records for personnel can hinder compliance and oversight by health inspectors.
Documents used along the form
The Biomedical Waste Operating Plan form is an essential document for facilities that handle biomedical waste. Alongside this form, several other documents can help ensure compliance with regulations and facilitate effective waste management. Below is a list of related forms and documents that are often used in conjunction with the Biomedical Waste Operating Plan.
- Decontaminating Biomedical Waste Spills Procedure: This document outlines the recommended steps for safely cleaning up spills of biomedical waste. It provides guidance on the materials needed and the protocols to follow to minimize risk.
- Spill Kit Contents List: This list details the items that should be included in a spill kit specifically designed for biomedical waste. Having the right tools readily available can significantly enhance safety during an incident.
- Biomedical Waste Generator Permit Application: This application is required for facilities generating biomedical waste to obtain the necessary permits or exemptions from the Florida Department of Health. It ensures that the facility is compliant with state regulations.
- Biomedical Waste Training Outline: This outline serves as a guide for training staff on proper biomedical waste management practices. It covers key topics such as identification, segregation, and handling of biomedical waste.
- Biomedical Waste Training Attendance Records: These records document attendance at training sessions for employees. Keeping accurate attendance records is vital for compliance and can be requested during inspections.
- Plan for Treatment of Biomedical Waste: This plan details how a facility intends to treat its biomedical waste. It is necessary for facilities that manage their waste on-site and need to comply with treatment regulations.
- Transport Log for Biomedical Waste: This log tracks the movement of untreated biomedical waste from the facility to a treatment or disposal site. Maintaining this log is essential for accountability and compliance with transport regulations.
- Biomedical Waste Inspection Records: These records document past inspections of the facility regarding biomedical waste management. Keeping these records helps demonstrate compliance over time and is useful during audits.
By utilizing these forms and documents, facilities can better manage their biomedical waste and ensure compliance with state regulations. Each document plays a vital role in maintaining safety and accountability in the handling of potentially hazardous materials.
Similar forms
The Biomedical Waste Operating Plan form shares similarities with several other documents related to biomedical waste management. Each document serves a specific purpose within the framework of compliance and operational efficiency. The following list outlines these documents and their connections to the Biomedical Waste Operating Plan:
- Biomedical Waste Generator Permit Application: Similar to the Operating Plan, this application is essential for facilities to obtain permission to generate biomedical waste. Both documents require detailed information about waste management practices.
- Biomedical Waste Training Outline: This outline details the training necessary for personnel handling biomedical waste, paralleling the training requirements mentioned in the Operating Plan.
- Biomedical Waste Training Attendance Record: This document tracks attendance for training sessions, reinforcing the training protocols established in the Operating Plan.
- Contingency Plan for Biomedical Waste Spills: Like the Operating Plan, this document addresses procedures for managing spills, ensuring safety and compliance in both instances.
- Biomedical Waste Treatment Plan: This plan outlines the methods for treating biomedical waste, similar to the containment and treatment procedures described in the Operating Plan.
- Biomedical Waste Transport Log: This log records the transport of biomedical waste, aligning with the transportation protocols specified in the Operating Plan.
- Inspection Records: Facilities must maintain records of inspections, similar to the documentation requirements in the Operating Plan, to demonstrate compliance over time.
- Decontamination Procedures for Biomedical Waste: This document provides guidelines for decontaminating waste, which is also addressed in the Operating Plan, emphasizing the importance of safety measures.
Dos and Don'ts
When filling out the Biomedical Waste Operating Plan form, it’s crucial to follow certain guidelines to ensure compliance and safety. Here are four things you should and shouldn't do:
- Do enter the correct name of your facility in the designated blank.
- Do keep records of employee training accessible for review by inspectors.
- Don't leave any blanks unanswered; if a question does not apply, indicate "N/A."
- Don't forget to list all items of biomedical waste generated in your facility.
Misconceptions
Understanding the Biomedical Waste Operating Plan form is crucial for compliance and safety in healthcare settings. However, several misconceptions can lead to confusion. Here are eight common misconceptions explained:
- It is mandatory to use the Biomedical Waste Operating Plan form. The use of this plan format is voluntary. It is provided to assist facilities in complying with regulations but is not a requirement from the Department of Health.
- All facilities must use red bags for biomedical waste. Not all facilities are required to use red bags. If a facility does not use them, they should simply indicate "N/A" in the relevant sections of the form.
- Training records are not necessary. Maintaining training records is essential. Facilities must keep these records for a minimum of three years for review by Department of Health inspectors.
- Only large facilities need a Biomedical Waste Operating Plan. Any facility that generates biomedical waste, regardless of size, should have an operating plan to ensure proper management and compliance.
- Biomedical waste can be disposed of in regular trash. This is incorrect. Biomedical waste must be managed according to specific guidelines to prevent potential health risks.
- There is no need for a contingency plan. Every facility should have a contingency plan in place. This plan outlines procedures for emergencies, including spills and transport issues.
- All employees are automatically trained. Training must be scheduled and documented. It is not automatic; facilities must actively ensure that all staff receive proper training.
- Only the facility manager needs to understand the plan. All personnel involved in handling biomedical waste should be familiar with the operating plan to ensure safety and compliance.
Key takeaways
Filling out and using the Biomedical Waste Operating Plan form is essential for compliance and safety. Here are key takeaways to keep in mind:
- Identify Your Facility: Clearly enter the name of your facility at the beginning of the form.
- Document Training Records: Specify where employee training records will be stored for easy access.
- List Biomedical Waste: Accurately describe the types of biomedical waste generated and their locations within your facility.
- Use Compliant Bags: Ensure that the manufacturer of your red bags is on the Department of Health’s approved list.
- Storage Procedures: Provide details on where biomedical waste will be stored, ensuring the area is washable and restricted from client traffic.
- Transport Information: Include the name of your registered biomedical waste transporter and their details.
- Spill Procedures: Outline the procedures and products used for decontaminating any biomedical waste spills.
- Maintain Records: Keep records of inspections, training, and permits for at least three years for compliance checks.
- Emergency Contingency Plan: Have a clear plan in place for emergency transport of biomedical waste.
By following these guidelines, your facility will be better prepared to manage biomedical waste responsibly and in accordance with regulations.