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Managing biomedical waste is crucial for ensuring public health and environmental safety. The Biomedical Waste Operating Plan form acts as a guiding document for healthcare facilities, assisting them in the proper handling and disposal of hazardous materials. This comprehensive plan outlines critical aspects such as personnel training, waste identification, storage, and spill decontamination procedures. It covers essential processes for ensuring compliance with regulations set forth in Chapter 64E-16 of the Florida Administrative Code, providing facilities with necessary guidelines to mitigate risks associated with biomedical waste. Key elements of the form include directions for filling out the plan, a detailed table of contents, and attachments like training outlines and attendance records. By following this structured approach, facilities will not only demonstrate their commitment to safety but also ensure that they are prepared to respond effectively to any incidents, thereby protecting both healthcare workers and the environment.

Biomedical Waste Operating Plan Example

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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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 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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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 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)

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 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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ATTACHMENT A: BIOMEDICAL WASTE TRAINING OUTLINE

Facility Name:

Trainer’s Name:

Outline:

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Form Characteristics

Fact Name Details
Governing Laws This plan aligns with Chapter 64E-16, Florida Administrative Code (F.A.C.) and section 381.0098, Florida Statutes.
Purpose The plan provides guidance on managing biomedical waste correctly in facilities to ensure compliance and safety.
Voluntary Use Utilizing this operating plan format is voluntary. Facilities can choose to adopt this format for their internal procedures.
Training Requirements Training for personnel is mandated. It ensures that employees understand and comply with the regulations outlined in this plan.
Record Keeping Facilities must maintain employee training records for a minimum of three years for review by Department of Health inspectors.
Waste Definition Biomedical waste is defined as any solid or liquid waste that poses a risk of infection to humans, including sharps and non-sharps.
Decontamination Procedures The operating plan includes specific procedures for decontaminating spills of biomedical waste to ensure safety and compliance.

Guidelines on Utilizing Biomedical Waste Operating Plan

Completing the Biomedical Waste Operating Plan form is essential to ensure proper management of biomedical waste in your facility. Following these steps will help you accurately fill out the form and maintain compliance with applicable regulations.

  1. Enter the name of your facility in Blank 1.
  2. In Blank 2, provide the location where employee training records are kept.
  3. List the items of biomedical waste produced in your facility in Blank 3, along with their locations of generation.
  4. For Blank 4, enter the name of the manufacturer of your facility’s red bags, ensuring this company is on the Department of Health compliant red bags list. If no red bags are used, enter N/A.
  5. In Blank 5, indicate where documentation for the construction standards of the red bags is kept, or enter N/A if not applicable.
  6. Blank 6 should reflect where unused red biomedical waste bags are located in operational areas. Enter N/A if red bags are not used.
  7. Enter the location of biomedical waste storage in Blank 7 and answer the questions regarding washability, traffic area, and restricted access.
  8. Provide the registered biomedical waste transporter information in Blank 8. If not applicable, enter N/A.
  9. For Blank 9, list the name(s) of any employee(s) designated to transport untreated biomedical waste. Enter N/A if this does not apply.
  10. In Blank 10, enter the name of the facility to which untreated biomedical waste is transported or N/A if it does not apply.
  11. Describe the decontamination procedure for spills in Blank 11.
  12. Enter the required information about your contingency transporter in Blank 12.
  13. For Blank 13, if applicable, provide the name of any branch office; otherwise, enter N/A.
  14. Blank 14 should include the street address, city, and state of the branch office or N/A if not applicable.
  15. Indicate the weekdays the branch office operates in Blank 15; enter N/A if there is no branch office.
  16. In Blank 16, explain the normal work hours for each day the branch office is open or enter N/A if not applicable.
  17. Provide the location of your biomedical waste operating plan in Blank 17.
  18. Blank 18 should indicate where the current biomedical waste permit or exemption document is located.
  19. In Blank 19, indicate the location of Chapter 64E-16 rules.
  20. Provide the location of inspection records from the last three years in Blank 20.
  21. For Blank 21, if applicable, enter where the transport log is kept; otherwise, enter N/A.
  22. Complete Attachments A and B as required and include Attachment C only if your facility treats biomedical waste.

What You Should Know About This Form

What is the purpose of the Biomedical Waste Operating Plan?

The Biomedical Waste Operating Plan provides essential guidance for the management of biomedical waste within a facility. It outlines necessary practices for the proper handling, storage, and disposal of biomedical waste in compliance with regulations established in Chapter 64E-16 of the Florida Administrative Code (FAC) and section 381.0098 of the Florida Statutes. By adhering to this plan, facilities can protect public health and minimize environmental risks associated with biomedical waste.

What training requirements are necessary for personnel handling biomedical waste?

Training for personnel is mandatory and must be scheduled regularly to ensure compliance with the operating plan and applicable regulations. Training sessions cover critical areas such as the definition and identification of biomedical waste, proper segregation methods, storage and labeling protocols, and procedures for decontaminating spills. It's vital that training records are maintained for a minimum of three years, allowing for review by inspectors from the Department of Health (DOH). Documentation of training sessions is essential to track participation and ensure accountability.

How does a facility ensure the proper containment and transportation of biomedical waste?

Proper containment of biomedical waste begins with selecting compliant red bags, which must meet established construction standards. Facilities must keep these bags readily accessible and store biomedical waste in designated areas that are both washable and out of client traffic areas to minimize exposure. Transportation involves using licensed biomedical waste transporters. Facilities should maintain records regarding the transporter's details and any documentation associated with waste pickup and transfer. If a facility does not have a transporter, they must outline their alternative procedures in the operating plan.

How can organizations ensure compliance with regulations regarding biomedical waste?

Compliance with biomedical waste regulations entails thorough documentation and consistent adherence to the guidelines specified in the operating plan. Each facility is encouraged to review and complete the blanks in the Biomedical Waste Operating Plan Form accurately. Keeping an updated copy of Chapter 64E-16 and inspection records for at least three years is crucial. Regular internal audits and training refreshers can help maintain awareness of best practices and regulations, promoting a culture of safety and compliance within the organization.

Common mistakes

Filling out the Biomedical Waste Operating Plan form can feel overwhelming, and it's easy to make common mistakes. One frequent error is not entering the facility name clearly at the top of the form. This basic information is crucial. Ensure that the name matches what is formally registered with the Department of Health to avoid any confusion in categorizing the waste generated by your facility.

Another mistake often made is neglecting to document the location of employee training records. Missing this element can lead to complications during inspections, as it impedes verification of staff training compliance. Make a note of where these records are stored; they should be easily accessible to both staff and health inspectors.

People frequently list items of biomedical waste without detailing the specific locations where they are generated. A precise inventory is vital for effective waste management and compliance with regulatory requirements. Clearly identify each type of waste and the corresponding area where it originates.

Providing inaccurate information about the manufacturer of red bags is another area where mistakes are often made. Confirm that the chosen manufacturer's details are current and that the bags meet the necessary construction standards mandated by Chapter 64E-16. It is essential to include accurate documentation about where the information on these bags is kept.

Some facility managers overlook how to handle biomedical waste storage. When indicating that biomedical waste is "washable," it’s important to describe the wash protocols in clear terms. Moreover, mention how access to the storage area is restricted. This ensures that safety practices are observed and that unauthorized personnel cannot access potentially hazardous waste.

A frequent oversight relates to the transportation of biomedical waste. Facilities often fail to list designated employees for transporting untreated waste. If your facility does not manage transport on its own, ensure that this is clearly indicated with “N/A” or a statement indicating as much.

Details regarding the contingency plan for emergencies can be inadequately described. Failure to outline procedures for spill management can put both staff and the environment at risk. Make sure the plan includes specific steps and materials needed to decontaminate a waste spill.

Finally, many neglect to specify where the current inspector’s copies of biomedical waste rules or previous inspection records are kept. Maintaining accurate historical data is critical for demonstrating compliance over time. Accurate record-keeping supports effective management practices and helps avoid potential non-compliance issues.

Documents used along the form

The Biomedical Waste Operating Plan form serves as a foundational document for managing biomedical waste in health facilities. To ensure compliance and safety, several supplementary documents accompany this form. Each of these documents plays a vital role in defining processes, training requirements, and compliance standards. Below is a list of five commonly used forms and documents that are crucial in conjunction with the Biomedical Waste Operating Plan.

  • Decontaminating Biomedical Waste Spills Procedure: This document outlines the step-by-step procedures for safely cleaning up and decontaminating spills of biomedical waste. It emphasizes the importance of immediate action and provides details on appropriate cleaning materials and methods.
  • Spill Kit Contents Checklist: This checklist specifies the recommended items for a biomedical waste spill kit. It ensures that facilities are equipped with the necessary tools to handle spills effectively. Items may include personal protective equipment, absorbent materials, and disinfectants.
  • Florida Department of Health Application for Biomedical Waste Generator Permit/Exemption: This application form must be completed for facilities generating biomedical waste. It includes information about the facility, the types and volumes of waste generated, and details on proper waste management practices.
  • Biomedical Waste Training Outline (Attachment A): This outline is a template for training programs designed to educate employees about biomedical waste management. It specifies required training topics, such as waste identification, segregation, and handling procedures.
  • Biomedical Waste Training Attendance Record (Attachment B): This form documents attendance at training sessions. It is crucial for compliance and must be maintained for a minimum of three years, showing that employees have received the necessary training.

In conclusion, these supplementary documents support the core objectives of the Biomedical Waste Operating Plan by ensuring that facilities manage biomedical waste effectively. Proper adherence to these forms and procedures enhances safety for both personnel and the public, reflecting a commitment to responsible health care practices.

Similar forms

The Biomedical Waste Operating Plan form shares similarities with several other important documents related to the management of biomedical waste. Here’s a list of those documents along with a brief explanation of how they are similar:

  • Biomedical Waste Training Outline: Like the operating plan, this document provides instructions and guidelines on handling biomedical waste effectively and ensures personnel are educated on necessary procedures.
  • Biomedical Waste Training Attendance Records: This document records attendee participation in training sessions, which is a crucial aspect of ensuring compliance outlined in the operating plan.
  • Decontaminating Biomedical Waste Spills Procedures: Similar to the operating plan, this document outlines specific steps and protocols for managing spills, emphasizing safety and compliance.
  • Application for Biomedical Waste Generator Permit/Exemption: This application directly relates to the operating plan by setting the foundational requirements needed to operate as a biomedical waste generator.
  • Chapter 64E-16, Florida Administrative Code: This regulation provides the legal framework and requirements for healthcare facilities, akin to the operating plan that aims to guide compliance with these regulations.
  • Plan for Treatment of Biomedical Waste: This document covers the protocols for treating biomedical waste, complementing the management guidelines provided in the operating plan.
  • Spill Kit Contents Guidelines: These guidelines outline essential materials and procedures needed for addressing spills, similar to the emergency procedures described in the operating plan.
  • Transporter Documentation: Details related to registered biomedical waste transporters align with the operating plan’s requirements for safe transport practices to ensure compliance.
  • Contingency Plan: Just as the operating plan includes contingency measures, this document specifically addresses the procedures that should be followed in case of unexpected situations.

Dos and Don'ts

When filling out the Biomedical Waste Operating Plan form, there are several important do's and don'ts to keep in mind. Here’s a concise list to help ensure accuracy and compliance.

  • Do enter the name of your facility clearly in Blank 1.
  • Do specify where employee training records are kept in Blank 2.
  • Do list all items of biomedical waste generated at your facility in Blank 3.
  • Do verify that your red bag manufacturer is on the DOH compliant list in Blank 4.
  • Don't use abbreviations or unclear terms in any of the blanks.
  • Don't leave any blank unfilled unless it is specifically marked as N/A.

Misconceptions

  • Misconception 1: The Biomedical Waste Operating Plan is mandatory for all facilities.
  • This form is actually a voluntary tool provided by the Department of Health (DOH) to assist facilities in managing biomedical waste. While following its guidelines can help ensure compliance with relevant regulations, facilities are not obligated to use this specific format.

  • Misconception 2: All biomedical waste must be stored in red bags.
  • While red bags are commonly associated with biomedical waste, their use is not universal. If a facility does not utilize red bags, it simply needs to denote this on the form by entering "N/A" where applicable, rather than facing penalties.

  • Misconception 3: Training records for biomedical waste management can be kept indefinitely.
  • Facilities must retain training records for a minimum of three years, as stated in the operating plan. After this period, they can dispose of the records, which are only required to be available for review during inspections by DOH representatives.

  • Misconception 4: All biomedical waste needs to be treated on-site.
  • Not all facilities have the capacity or need to treat biomedical waste themselves. If a facility chooses to use a licensed waste transporter, they merely need to document their procedures for preparing waste for transport, rather than managing treatment themselves.

  • Misconception 5: The contents of the Biomedical Waste Operating Plan are the same across all states.
  • Each state has its own regulations and guidelines governing biomedical waste. Florida’s requirements, outlined in the Biomedical Waste Operating Plan, reflect its unique legal framework and may differ significantly from those of other states.

Key takeaways

When filling out and using the Biomedical Waste Operating Plan form, keep these key takeaways in mind:

  • Understand the Purpose: The plan provides guidance and outlines requirements for managing biomedical waste in compliance with state regulations.
  • Complete All Sections: Ensure that each blank in the form is filled out accurately, including facility name, waste locations, and transport details.
  • Document Training: Schedule regular training for staff. Keep records of training sessions for a minimum of three years for review by the Department of Health (DOH).
  • Identify Biomedical Waste: Clearly define what constitutes biomedical waste and identify where various waste types are generated in your facility.
  • Use Compliant Materials: Only use red bags from manufacturers that meet the compliance standards outlined by the DOH.
  • Contingency Planning: Develop and document a contingency plan for emergencies, including spill decontamination and transport procedures.

These steps are essential for ensuring the proper handling and management of biomedical waste in adherence to state laws and health standards.