Road to USP <800> Compliance
Section 17: Documentation and Standard Operating Procedures
Sections 1 through 16 of USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settings provides the ground work for setting up a hazardous drug safety program for healthcare facilities. In section 17, we have to put the plan to paper. When we commit to putting things to writing we commit to the processes. It can easily be assumed from a safety and legal stand point; if it is not documented, it did not happen.
USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings has many steps, tasks, checks and processes that require documentation.[i]Documentation of critical steps are in place for patient safety, but also legally for employee safety. It is a requirement that each site that handles and manages hazardous drugs have standard operating procedures (SOPs) in place. The directional philosophies and processes of how a business runs are defined within SOPs. As a point of clarification of terminology: USP relies on terminology commonly used within scientific quality standards as in the case for the term SOPs; which draws from the International Organization of Standards ISO 9000:5000 definition for Quality Management Systems. In ISO, the words “process,” and “procedure,” are technical terms. In brief, a procedure is a “specified way to carry out an activity or a process,” and, a process is a “set of interrelated or interacting activities which transforms inputs into outputs.” Whereas, policies and procedures (PPs) are generically defined: “policies of an organization are the clear, concise statements of the parameters by which an organization conducts its business, (i.e., the rules staff abide by), and procedures “are the instructions or steps that describe how to complete a task or do a job.”[ii] SOPs are often considered interchangeable with PPs, but as we can see they might not be when it comes to scientific standards.
The following outlines steps should sites consider when drafting SOPs for critical standards.
- Use a standard and formal template for all SOPs and accompanying forms;
- Business may have one developed with legal notations
- For guidance sites can refer to ISO 9000:2005
- Create a team of stakeholders to draft and review SOPs
- For USP <800> and proposed USP <797> it is a required to assign a designee for SOP development
- Work out the purpose for the SOP
- What are you looking to achieve?
- What is the regulatory and/or standard requirement?
- Determine the structural contents and formatting of the SOP.
- Prepare and define the scope of the procedure
- Use a consistent style with correct notations
- Use USP language, example ‘hazardous drugs’ versus ‘oncolytics’
- Work out all the necessary steps of the process
- Consider creating a flow diagram
- Try to assess any problems in the process
- Establish required documentation points and or metrics
- Share the SOP with leadership prior to review with personnel
- Test the process
- Finalize the SOP if validated through steps 10 and 11
- Continually optimize the process
- Review at least every 12 months
To know whether processes are performing well or poorly, sites should develop metrics to judge it against. It is not good enough to assume processes simply work. Sites should understand how it is performing so that it can be monitored and optimized.
The SOPs can be globalized within a system for consistency, however, some specific SOPs may need to be site specific. Within USP <800> it requires that SOPs are reviewed every 12 months. For some systems, this may be more frequent than defined for your system for standard review frequencies of SOPs. The importance of continually reviewing, modifying and improving the compounding processes should be a directive for compounding programs. Documentation of the review and any revisions must be documented on each SOP. If revisions to the SOPs occur, the changes must be communicated to all persons in job codes where handling hazardous drugs are defined.
Within section 17, USP provides a listing of suggested SOPs for sights to consider (note it mirrors the sections within the chapter). It is important to keep in mind, USP <800> references the supporting chapters and references which should be referenced within SOPs. At a minimum, sites should use the list and title them as USP has to ease inspections and questions that may arise:
- Hazard communication program
- Occupational safety program
- Designation of hazardous drug areas
- Use and maintenance of proper engineering controls (i.e., C-PEC’s; C-SECs; CSTDs)
- Hand hygiene and use of PPE based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal)
- Deactivation, decontamination, cleaning and disinfection
- Environmental monitoring (e.g., wipe sampling)
- Spill control
- Medical surveillance
Obviously, sites will have differences between specialties, services, equipment, and state-specific regulatory requirements. The minimal SOP list from USP may not meet all needs for hazardous drug handling. Additional SOPs for sights to consider (disclosure not complete):
- Crushing, splitting and compounding oral solids
- Intrathecal administration of hazardous drugs
- Bladder installation of hazardous drugs
- Ampule management of hazardous drugs
- Compounding topical hazardous drugs
- BCG and biological vector cleaning protocol
- Immuno-gene therapy compounding
- Immuno-gene therapy cleaning protocol
- Immuno-gene therapy disposal protocol
- IV-Workflow equipment maintenance and calibration
- IV-Workflow equipment cleaning
- Visual inspection of hazardous drug products for dispensing
- Use of Powered Air Purifying Respirator (PAPR)
- Personal Protective Equipment integrity inspection
- Linen exchange process for patients receiving hazardous drugs
- Laboratory handling of body fluid samples of patients receiving hazardous drugs
- Phlebotomy procedures for drawing samples of patient receiving hazardous drugs
- Recycling assessment of returned compounding hazardous drugs
- Vinca alkaloids safety program
Within the documentation section, USP <800> reminds us that individuals “who transport, compound, or administer HDs must document their training according to OSHA standards (see OSHA Standard 1910.120 Hazardous Waste Operations and Emergency Response) and other applicable laws and regulations.” Highlighting the overall importance of documentation and the documentation requirements of outside agencies.
Here is the link to the OSHA HAZWOPER standard FAQ: https://www.osha.gov/html/faq-hazwoper.html
As the official implementation date of December 1, 2019 for proposed USP <800> and subsequent revisions to USP <795> and USP <797> compliance allows time for sites to prepare for overall compounding compliance. The time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP is now.
Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.
[i]USP <800> Hazardous Drugs—Handling in Healthcare Settings. First Supplement to USP 39–NF 34 Physical Tests. www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed August 14, 2018.