Pharmacies Are Renovating Space to Comply With USP 800

Research studies over the past several decades have indicated the possible harmful effects on healthcare workers from low-level work-related exposure to any of more than 200 medications that are considered hazardous drugs. As a result, the United States Pharmacopeia (USP) — a nonprofit compendium of drug information — published the nation’s first standards on the handling of hazardous drugs from receipt to disposal. Chapter 800, titled “Hazardous Drugs — Handling in Healthcare Settings,” applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport, or administer hazardous drugs, such as pharmacies, hospitals, clinics, and physician offices. Hazardous drugs include those used for cancer chemotherapy, antiviral drugs, hormones, and some bioengineered drugs. Most existing pharmacies will need to modify their workflow, space, and infrastructure to comply with USP 800 when it becomes effective on December 1, 2019.

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The Hospital Pharmacy — Now a Sophisticated Manufacturing Plant

Automation — with the barcode as the foundation — has transformed the hospital pharmacy into a high-tech manufacturing plant that allows pharmacists to focus on direct patient care. Although automation in the pharmacy requires a significant capital investment, it reduces labor costs, lowers the risk of dispensing errors, optimizes inventory control, and provides better security, among other benefits.

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The Death of the Hospital Autopsy

Autopsies ― sometimes called the ultimate medical audit ― were an integral part of American healthcare a half-century ago and were performed on roughly half of all patients who died in hospitals. Up until 1971, the Joint Commission required that community hospitals perform autopsies on 20 percent of inpatient deaths, increasing to 25 percent for teaching facilities, as part of earning accreditation. Although hospitals are still required to develop criteria for autopsies, and should “attempt to secure autopsies in all case of unusual death” and in cases of “medical, legal, educational interest,” it is rare today when a hospital has an autopsy rate of more than 5% for nonforensic deaths according to data from the Centers for Disease Control and Prevention. Some pathology experts say it is usually only about 1%.

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Case Study: Planning a Medical Procedure Unit

Historically, same-day medical procedures at Midwest Medical Center have been provided by a variety of different departments and scattered throughout the hospital with redundant patient reception/waiting, preparation, treatment, and recovery spaces. As demand for same-day medical procedures continued to grow, the hospital leadership was concerned that outpatient satisfaction was being compromised while operational costs were increasing dramatically. Department staff were inpatient-focused and reluctant to alter pre-established protocols and processes. They were also reluctant to consider any changes to their existing “turf.”

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Ten Key Questions When Planning the Clinical Laboratory

Laboratory testing has grown from a manual, “hands-on” process providing a simple test menu — with staff organized by testing methodology or discipline in multiple small rooms — to an automated, multidisciplinary, high-volume instrument-centric clinical enterprise. A visit to a hospital laboratory today reveals a varying array and number of instruments, often operating with little human intervention. While test volume and staffing were once used to determine the amount of space in a laboratory, today, the instruments and degree of automation dictate the test volume capacity. The number of staff required to support the instrumentation is then determined.

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Planning an Outpatient Pharmacy: Small, Medium, or Large?

Most outpatient pharmacies that are located within a hospital or in an ambulatory care center (on or off-campus) fall into one of four categories ― minimal, small, medium, or large. Assuming that outpatient demand has been established based on the availability and convenience of similar services and potential competition from commercial pharmacies, the primary determinant of an outpatient pharmacy’s size is the average number of daily prescriptions (scripts) that will be filled during the busiest eight-hour shift. This generally determines the numbers and sizes of rooms or areas and overall space.

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