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USP 800 Compliance Date Approaching: ALM Provides Tools for the Industry

Thursday, November 14, 2019   (0 Comments)
Posted by: Nicole Morris
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Richmond, Ky., November 14, 2019 — USP 800 was published by the U.S. Pharmacopeial Convention in February 2016 to describe practice and quality standards for handling hazardous drugs in healthcare settings. These guidelines were developed in an effort to promote patient safety, worker safety, and environmental protection. The deadline for compliance with USP 800 is December 1, 2019. USP 800 requirements do not address laundries, but require healthcare facilities (hospitals, clinics, etc.) to take proactive measures to identify linen from patients that have received hazardous drugs within the last 48 hours.

According to the Centers for Disease Control & Prevention, approximately 8 million healthcare workers annually are exposed to hazardous drugs (HDs). Exposure to hazardous drugs can result in adverse health effects in healthcare workers. Published studies have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects, such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers.[i]

The key focus of USP 800 lies with the pharmacy, clinicians administering the medication, and managing spills appropriately. However, transport, waste, and patient care activities involving handling clothing, dressings, linens, and other materials contaminated with urine, feces, sweat, or vomit are the points that concern the healthcare laundry service providers.

ALM provided guidance for handling linens exposed to hazardous drugs in 2004, and that guidance remains an excellent practice for maintaining a safe work environment for healthcare laundry processing facilities and aligns well with the revised OSHA guidance.[ii] The challenge for healthcare laundries has always their inability to distinguish linens from patients who had received hazardous drugs in the previous 48 hours and other linens. Compliance with USP 800 provides laundries and their healthcare customers with the opportunity to work together to establish lines of communication that will comply with the standard, as well as keep employees safe in an efficient and equitable manner.

From Barry Spurlock, partner at Crump Spurlock Attorneys of Law and safety professor at EKU, “There currently exists no specific Federal OSHA standard regulating employee exposure to the hazards of handling hazardous drugs. However, laundry employers should still be aware that OSHA requirements and liability may exist even in the absence of such standards. Even in the absence of a specific state or Federal OSHA standard[iii] on employee exposure to HDs, laundry employers may still be cited pursuant to Federal or state OSH Act general duty clauses. Additionally, there may still be requirements pursuant to general OSHA standards on hazard communication (Hazcom), employee medical records, etc. Accordingly, it is prudent that laundries provide a safe employee environment by engaging their healthcare customers in discussions regarding the laundry’s policies and requirements for the hospital or clinic. These policies and procedures should require that the healthcare customer properly identify and then segregate, mark, bag, etc., textile products before sending to them to the laundry so that laundry workers may identify HD contaminated laundry and take necessary precautions to protect themselves from exposure. To ensure such agreements and policies are bona fide in OSHA’s eyes, laundries should conduct purposeful audits/inspections of the policies and procedures to ensure they are being followed by the healthcare customers, and then ensure documented, corrective action is taken when audit/inspection findings and/or exposure incidents have occurred. Diligent efforts to minimize employee exposure, follow industry best practices and follow up on noted deficiencies are critical steps in minimizing OSHA liability, and most importantly protecting laundry workers.”

ALM has provided these tools to help industry laundries prepare:

We encourage you to share the steps and measures your operation has/is taking to protect front-line laundry workers from undue exposure to hazardous drug contaminated textiles.

About ALM

The Association for Linen Management (ALM) is a non-profit trade association dedicated to the operational excellence and professional development of personnel involved in the textile care industry. Our members are owners, general managers, laundry directors, managers, and technicians providing textile care services, as well as the equipment and supply companies who provide materials and consulting services for the textile care industry. ALM advances excellence in the textile care industry for healthcare, hospitality, correctional facilities, and long-term care providers through guidance in textile processing, management, and utilization, and is the only source for laundry processing benchmarking data through the revolutionary LaundryMarksTM platform. Visit ALM’s website to learn more about the organization, its members, and the importance of the laundry industry. 



[i] Centers for Disease Control. “Hazardous Drug Exposures in Healthcare.” CDC, https://www.cdc.gov/niosh/topics/hazdrug/default.html. Accessed 12 November 2019.

[ii] U.S. Department of Labor. “Controlling Occupational Exposure to Hazardous Drugs.” OSHA, https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html. Accessed 12 November 2019.

[iii] Washington Health Care Association. “Washington Hazardous Drugs Rule.” WHCA, https://www.whca.org/washington-hazardous-drugs-rules/. Accessed 12 November 2019.