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COMPLIANCE


Managing Medical Equipment Follow accrediting bodies’ requirements BY RAY MARDEN


When a medical device arrives at an ASC it becomes subject to man- agement under at least 14 different Elements of Per-


formance (EP) within The Joint Com- mission (TJC) Environment of Care (EC) Standards, 2019 Environment of Care, Essentials for Healthcare. How- ever, it is important to understand that the requirements for all accrediting bodies stem from Centers for Medi- care & Medicaid Services (CMS) guidelines and are essentially the same from a medical equipment man- agement perspective. There are many types of medical equipment used in the ASC Environ- ment of Care (EOC). Medical equip- ment can be defined as any equipment, fixed or portable, that is used for thera- peutic, diagnostic, treatment, life-sup- port, or analytical purposes. Any pow- ered instrument that attaches to or is used in treatment of patients is medi- cal equipment. While there are several variations in equipment ownership, it does not mean that there are variations in responsibility. It is common practice to have rentals, demos and physician owned equipment deployed in the ASC EOC. These “transient assets” must be managed to the same standards as all other equipment in the facility. This duty must fall to the ASC to ensure quality. Transient assets have their own associated risks and could be the sub- ject of a separate discussion. For now, we will assume a new device has just arrived at an ASC and follow the steps it takes as it makes its trip from the loading dock to the EOC via a Med- ical


Equipment Management Plan (MEMP).


When a medical device arrives at an ASC it becomes subject to management under at least 14 different Elements of Performance (EP) within The Joint Commission (TJC) Environment of Care (EC) Standards, 2019 Environment of Care, Essentials for Healthcare.”


—Ray Marden Insight HTM, LLC


MEMP


Before equipment can be deployed into the EOC, the organization must have a written MEMP in place, according to TJC EC 01.01.01. EP8. A good MEMP will describe how the organization will establish and maintain its Healthcare Technology Management (HTM) pro- gram. This plan is a high-level overview of the HTM policies and procedures that will be followed to address medi- cal device safety in the EOC, as well as meet regulatory requirements. A Cer- tified Healthcare Technology Manager (CHTM) is the best resource for mak- ing sense of the many different EPs and ensuring that your MEMP has a plan to address them all. Included within the MEMP should be a policy regarding pre-use checks, also known as incom- ing inspections. A good MEMP will be easy to understand and inspire con- fidence that all medical equipment is being managed safely, efficiently and according to guidelines.


20 ASC FOCUS NOVEMBER/DECEMBER 2019| ascfocus.org


Written inventory: The device has been shipped to the ASC and is now in receiving. The EPs are very clear about what happens next. The MEMP will include a policy that specifically addresses incoming inspections and a procedure set that lines out how to perform them. TJC EC 02.04.01 EP2 states that the organization must maintain a written inventory of all medical equipment. Thus, any device that will be used in the EOC must first be accounted for in a written inven- tory. The best way to accomplish this is with a Computerized Maintenance Management Software (CMMS) sys- tem that is set up and managed by an HTM specialist. The CMMS will come in to play as again when all the EPs are addressed. For now, our device needs to be added to the inven- tory, it should also be assigned a unique identifier, known as an asset number. The model number, name, manufacturer, serial number and date of manufacture are all good metrics to include in the inventory.


Pre-use evaluation: Now that the asset tag is assigned and the device is in the inventory, there is some- where to document the service that accompanies the device through- out its life cycle. The device can now undergo the actual pre-use checks or incoming inspection. TJC Standard EC.02.04.03 EP1 states that before initial use of medical equipment on the medical equipment inventory, the organization performs safety, opera- tional and functional checks. Accord- ing to another EP, EC.03.01.01 EP1, the staff responsible for doing the checks must be competent and trained to do so. This can be an HTM profes-


The advice and opinions expressed in this column are those of the author and do not represent official Ambulatory Surgery Center Association policy or opinion.


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