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The Basics of USP 797 & 800

Is Your Organization Prepared?

october 2023

By Jody Randall MSN, RN, CIC, HACP-CMS, HACP-PE

CEO and Founder

USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, delineates the standards for compounding sterile preparations in all pharmacy settings. USP 800 provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Effective November 1, 2023, changes to these standards will be fully adopted and organization must demonstrate compliance.


 One of the first considerations for ensuring compliance with USP 797 and 800 is to evaluate your organization’s current practices. The next most important step is to identify a qualified person to evaluate current practices, implement policies and procedures and oversee training. Conducting a risk assessment of current practices is a great way to begin.


 A good approach to beginning to establish or revise a program that manages hazardous pharmaceuticals is to reconcile current medications on formulary. In doing so, you may determine that some of the medications listed are not necessarily being used. This is a common finding when providers who have requested medications be ordered are no longer practice at your facility. Eliminating these medications will not only help to minimize the actual number of hazardous medications but can also lead to tremendous cost savings for organizations.


 Another point of focus should be evaluating how these medications are currently being handled within the organization. Handling hazardous medications should be done in a manner that is safe and reduces risk of harm to employees who come into direct contact with these medications. 


Having the right equipment, ventilation, personal protective equipment, and cleaning products requires planning and collaboration. For organizations that are performing sterile compounding, we strongly recommend looking at how this work is being performed and identifying breaches in the process. The National Institute for Occupational Health and Safety (NIOSH) has published THIS ALERT that covers risks associated with hazardous pharmaceuticals.  

a man in a lab coat and mask is holding a yellow cloth .

Moving Forward
We highly recommend reviewing this publication which provides a comprehensive overview of topics related to prevention exposure to antineoplastic and hazardous drugs in healthcare settings. You will find helpful recommendations ranging from proper personal protective equipment to waste disposal .


Once all risks have been identified, be sure to work toward corrective actions that will not only mitigate risk but will ensure safety for those who work in these high-risk areas. There are several changes that have been adopted that will be in effect. All hazardous drugs, even if low volume, must be prepared in a negative pressure space.


The Joint Commission has also published a chapter on Revisions to Medication Compounding Requirements . This is another great tool that can be used in determining your organization’s compliance with Medication Compounding revised standards. Whether your healthcare facility is considered a large or small generator of hazardous pharmaceuticals, you will still be held to existing and updated standards concerning hazardous pharmaceuticals. 


Now is a great time to take a closer look at your facilities, current processes and make improvements as necessary. We understand that preparation, management, and disposal of hazardous pharmaceuticals can be a complex matter but if not done correctly can cause harm to patients and staff. These types of adverse events can lead to litigation, financial burden and impact reputation and accreditation status for organizations.

 

When in doubt, call the experts for help! HCE is Here
Healthcare Consulting Experts LLC was built based upon our understanding of the challenges that healthcare facilities are facing today. Healthcare professionals strive to deliver the best possible care to all patients. We can help your facility through the difficult times and put you back on track to a less stressful tomorrow.


 Don’t take chances! Our experts can assist with regulatory compliance requirements for whether you are building a new, state-of-the-art project or renovating an existing structure. Be sure to visit Our Website  to see a full list of the services that we provide.
Contact us today at +1 (800) 813-7117 for a free initial consultation.


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References:

https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf?id=10.26616/NIOSHPUB2004165

https://www.jointcommission.org/-/media/tjc/documents/standards/prepublications/effective-2023/prepub_mc_requirements_for_ome_jan2024.pdf

Healthcare Consulting Experts LLC

NSHN and OSHA Reporting: Prepared to Meet the Deadline?

February 10, 2025
It is that time of year again. At least for acute care hospitals, long-term acute care (LTAC) hospitals and inpatient rehabilitation facilities (IRF) who report to The National Healthcare Safety Network (NHSN). If annual surveys are not reported by March 1 st , then your organization will not be permitted to enter monthly reporting plans until the annual survey has been completed. Although there are just a few weeks to go, early planning is the key. It is important to consider that responses to the Annual Survey questions are a collaborative effort. Planning a meeting in advance with key stakeholders will help to ease the stress of completing what some may consider to be a daunting task. Be sure to coordinate with Facilities Managers, Pharmacists, Laboratory, Nursing, Infection Prevention and Quality leaders on annual survey responses. Although individuals who are responsible for report submission may find that some of the data has not changed significantly from the previous year, we have identified that some questions have been removed while additional questions have been added. If you are new to NHSN reporting and have not yet completed an annual survey, you will find an alert reminding you on your dashboard upon logging in. Keep in mind that the survey you are completing requires data from the previous calendar year. You will be submitting data for 2024 due March 1 st , 2025. There are a variety of questions that will require information about metrics, facility type, infection prevention practices, laboratory testing methods, water quality management, and antimicrobial stewardship practices for example. Instructions on completing your organization’s annual survey click on the link below that corresponds with your facility type: Instructions for Completing Annual Hospital Survey Instructions for Completing LTAC Annual Survey Instructions for Completing IRF Annual Survey OSHA requires the following facilities to complete an annual occupational injury and Illness Report: Ambulatory Health Care Servies General Medical and Surgical Hospitals Psychiatric and Substance Abuse Hospitals Specialty Hospitals Skilled Nursing Facilities For a complete list of facilities required to report annually via electronic submission and for additional information on Standard 1904 Subpart E Appendix B click on the following link: OSHA Injury and Illness Reporting Requirements . Much like NHSN annual surveys, this reporting is also for the prior calendar year. Your deadline for submission is March 2, 2025. If your organization has not previously been reporting, please note that you will need to set up an Injury Tracking Application (ITA) account. For complete instructions, click on the following link User Guide . Individuals who are responsible for report completion and submission should have a clear understanding of criteria that constitutes a work-related injury. They will also need to know if the employee missed days of work because of injury or illness. If an employee was restricted from usual work activities or reassigned to a new role as a result of the injury or illness this information must be documented. If an employee required care beyond basic first aid, this will also need to be reported. Reporters should not include Protected Health Information (PHI). For a brief tutorial on OSHA annual reporting requirements, click on the following link OSHA Injury and Illness Reporting . Our experts understand the challenges that all healthcare facilities are facing today. Using a customizable approach, we will help you navigate through even the toughest of challenges. Whether you are in need of mock surveys, leadership training, corrective action plans or ongoing support services, we can help! We pride ourselves on helping our clients achieve and maintain a status of excellence in the healthcare industry. Be sure to browse Our Website for a full list of services we provide. Contact us today at +1 (800) 813-7117 to schedule a free consultation. References: https://www.cdc.gov/nhsn/forms/instr/57_103-toi.pd https://www.osha.gov/laws-regs/regulations/standardnumber/1904/1904SubpartEAppB https://www.osha.gov/sites/default/files/ita_user_guide.pdf https://www.osha.gov/sites/default/files/osha_rktutorial.pdf
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