George Mills of The Joint Commission periodically answers questions from AAMI members on a variety of Joint Commission-related topics. A new question from an AAMI member — and an answer to the question from George Mills — are posted each Tuesday on AAMI’s Joint Commission eForum.
|Q: Will Alarm Safety reappear as a National Patient Safety Goal? If so, when? If not, will there be increased emphasis in this area as part of Joint Commission standards for hospitals?|
|A: No, alarms are not scheduled to be added to the National Patient Safety Goals for 2011. Surveyors will be made aware of the issues and survey how alarms are assessed and managed. (Oct. 2010)|
|Q: We have been using a mobile outlet system in our operating rooms for a number of years now. Recently, we’ve noticed this warning on the website of the mobile outlet system’s manufacturer — “Do not use relocatable power taps in general patient care areas or critical patient care areas. They have not been evaluated for use where article 517 of the National Electrical Code requires hospital grade components.” After seeing this caution we have decided not to purchase any more units of the product and are working on a phased-in replacement. Obviously, we would like to avoid any negative impact on a Joint Commission inspection. Do you have any recommendations for our facility (for example, should they be removed immediately)?
|A: The Joint Commission would expect immediate compliance with the National Electric Code (NFPA 70-1999) Section 517 and NFPA 99-1999 (see section 7-5.1.2). Relocatable power taps should be kept to a minimum, ensure assessment of load distribution should occur to prevent overloading, and at no time should relocatable power taps be daisy-chained. (May 2011)|
|Q: Do you know when The Joint Commission will be including the flexible and rigid scopes as an E.P.?|
|A: The Joint Commission standards will continue to be non-prescriptive, so I do not anticipate scopes being specifically called out in an EP. As mentioned at the AAMI Annual Meeting, all we are requiring is that scopes are included on the Medical Equipment inventory to ensure that proper management of them is occurring. Who is providing the service is totally up to the organization, similar to dialysis or sterilizers. The recent events around scopes that resulted in ECRI reporting them in their top 5 concerns have caused us to ensure they are properly managed, and identifying them on the Medical Equipment Inventory is appropriate. (May 2011)|
|Q: Is it true that The Joint Commission will have biomed departments inventorize the hospital rigid endoscopes? If so, is there any documentation coming from The Joint Commission describing this requirement?|
|A: Both The Joint Commission and ECRI have identified contamination issues related to scopes as a significant patient safety concern from information gathered from 2009 and before. The Joint Commission Environment of Care Handbook, 3rd Edition has included as a definition of medical equipment four categories: treatment, diagnostic, monitoring and patient support. Endoscopes are listed under diagnostic. With the recent patient safety concerns it is only reasonable to have scopes be included in the medical equipment inventory. This was discussed in AAMI News (August 2010 Vol. 45, No. 8, pg 9) where I mentioned that other than the reporting relationship, the organization continues to have full control over the management of their scopes. There is nothing in the article about oversight of the endoscopic department and their process by clinical engineering (in fact, I made sure to allow the current practice to continue). The goal of The Joint Commission is to have a process that is functional and raise the awareness of this issue to the organizations we accredit. Currently this is considered best practice and is not a specific Element of Performance. (Feb. 2011)|
|Q: Regarding the new Modality Accreditation standards, where it states that “the organization identifies activities and frequencies to maintain the reliability, accuracy, clarity and quality of the diagnostic image,” what evidence or supporting documentation will The Joint Commission be looking for from the CE dept during an inspection?|
|A: A surveyor would expect maintenance documentation similar to any other of piece of medical equipment. Based on those activities that the organization identifies for maintaining the reliability, accuracy, clarity and quality of the diagnostic image as required by the previous standard, appropriate documentation to show that those activities have been carried out. (Oct. 2010)|
|Q: Regarding the inventory element of performance (EP), and the choice to include all medical equipment or selected medical equipment, what do you see as the pros and cons of each approach? What are possible selection criteria for the latter approach?|
A: First, let’s discuss why we require an inventory. The inventory is related to maintenance activities to ensure the devices are reliable. All devices may be included in the inventory, provided that you are aware of all devices, that you assign a maintenance strategy to each, and a frequency of preventive maintenance.
Assume that today you have 8,397 devices (all devices). Tomorrow a new device arrives in the shop, but no one is aware of the delivery as most of your staff is out of the office for a corporate meeting. The few left behind are out and about when the device arrives. The next day, a biomed sees the device, and brings it down to central sterile, assuming it needs to be cleaned and placed into service. You now have 8,398 devices. Two weeks later a survey occurs, and you explain to the surveyor that all devices are in the inventory. The surveyor randomly selects a device and asks for the history of the device. You go to your inventory and discover it is not in the inventory. But your program includes all devices. Using a risk- based process reduces the total number of inventoried devices, provides a defendable explanation for devices that are not on the inventory based on a lack of risk, and provides an accurate assessment of devices receiving service. Possible selection criteria are up to the organization to define.
EC.02.04.01 EP 1 mentions “equipment categorized by physical risk associated with use” such as equipment that when used could potentially harm the patient or user and equipment history.
Life support devices are always included in the inventory. Many organizations use established models to assist in this process. (Feb. 2010)
|Q: I want to make sure I understand the survey correctly. All life support equipment needs to be in the inventory as I understand it. Lesser risk equipment may or may not be in the inventory as appropriate for experience, repair history, fault code analysis, etc. If we choose not to put something in the inventory, it is not required to have any tags (hospital asset, non-hospital owned, etc.)? Should we have "non-hospital owned" tags on equipment that does not belong to the hospital, for ease of survey purposes? My understanding is that we would be asked if equipment is life support, and if not, is it in the inventory. And if it’s not, then it is not questioned further. Am I correct?|
A: I’ll answer this question in a few parts below:
a. Equipment not in the inventory is not assessed against EC.02.04.03. If you have equipment that you need to track for asset management reasons only (these devices do not benefit from or receive any scheduled activities), they can reside in the inventory, but make it clear that these are not subject to EC.02.04.03 EP 3 but are only asset inventory items. Items not in the inventory (including these asset only devices) may or may not have tags, as per your policy.
b. Non-hospital owned equipment: if it serves patient needs it should be evaluated as per EC.02.04.01 EP 2 (determine if the equipment should be on the inventory). This will address risk to the patient of using non-hospital owned equipment.
c. When surveyed:
|Q: As medical systems migrate from independent networks to hospital IT networks, will there be Joint Commission standards to address risk assessment, security, and support strategies?
|A: There currently exists in EC.02.01.01 EPs 1 & 3 a requirement for risk assessment. Security of records (i.e. patient confidentiality) currently exists in IM.02.01.01; security and integrity of records is at IM.02.01.03. Also, in the IM chapter is Elements of Performance addressing data recovery and business continuity (IM.01.01.03). Support strategies are left up to the organization to allow flexibility for the relevant departments and the users. As each organization is unique, The Joint Commission allows for this flexibility. (May 2011)|
|Q: How should we address Home Care infusion and feeding devices that are issued on a lease-to-own basis? Most patients will take ownership of these devices in 11 months. Do we place these in our inventory until the release date, or treat them as patient-supplied devices from day one?|
|A: The organization should keep the device in the inventory until the patient completely owns the equipment. This allows for appropriate preventive maintenance and any corrective maintenance associated with the device during the time the organization has responsibility for the device. (Oct. 2010)|
|Q. Does equipment that has been designated as out of service (not retired) have the same requirements as those in service? Also, when equipment cannot be located for a period of time, is placing it out of service appropriate, or is retirement a better designation?|
|A. The Joint Commission is non-prescriptive regarding how you manage your equipment, whether in use, inactive, retired, or out of service. All of these situations are up to your management plan and processes to define. Concerns I would have with equipment “out of service” is whether the equipment is accessible to staff, and if so, could it be used? If the answer is “yes” the equipment must be maintained. In my experience whenever equipment was determined to be “out of service” we would render the device inoperable (i.e. by placing a locking device over the power plug so it cannot be energized) and appropriate labeling. (Oct. 2010)|
|Q. What is (if any) the requirement for maintaining the records of permanently disposed of medical or imaging devices?|
|A. Conduct a risk assessment, including getting input from a risk manager and reviewing internal policies, and review the Safe Medical Devices Act (if applicable). (Feb. 2011)|
|PREVENTIVE MAINTENANCE / MAINTENANCE STRATEGIES|
|Q. Regarding the grace period of 30 days for PM completion, is the intent that annual medical equipment maintenance scheduled for September 1 is out of compliance on October 1, or October 30? I understand our hospitals can set their own policies, but I am interested in clarifying the default Joint Commission policy please. Also, if semi-annual maintenance uses a 20-day instead of a 30-day grace period, would a device scheduled for September 1 be out of compliance on October 20, or on September 20?|
|A. Assume the work is scheduled on September 15. In the opinion of The Joint Commission the target is the month of September for the action to be completed. For an event that is repeated semiannually (March and September), there is a 20-day grace period prior to the first day of the scheduled month and after the last day of the scheduled month. For example, a due date of September 15 could be completed from 8/12 – 10/20 (all of September is included +/- the 20 days). A follow up clarification: if the work was completed on October 20, the next occurrence is not adjusted to the October date, but remains the original September : March cycle. (Oct. 2010)|
|Q. A follow-up to your statement about scheduled inspection completion window—is it the same +/- 30 days of the scheduled month for semi-annual and quarterly inspections? Life support equipment is still within the month it is scheduled?|
|A. Daily, weekly, monthly and quarterly are calendar time frames, the activity can be completed any day within the calendar reference, but may not exceed those calendar references. For example, if a monthly test normally occurs the 5th of the month, but is completed on the 25th of the month, it is still “on time.” If the same event is not completed in the calendar month, it is determined to be late. There is not any grace period outside the calendar reference. Semiannual is the month the activity is scheduled +/- 20 days; and Annual is the month the activity is scheduled +/- 30 days. Regarding life support: I would prefer all life support devices to be completed within the scheduled month, but would allow the 20 day +/- window to apply for semiannual (or the +/- 30 day window for annual). (Oct. 2010)|
|Q. Regarding the CMS decision on allowing “clinical engineering departments to use their choice of one of three strategies in setting preventive maintenance (PM) rates for organizations accredited by The Joint Commission,” what evidence or supporting documentation will The Joint Commission be looking for from the CE department during an inspection?|
|A. Surveyors will be asking staff how the scheduled activities have been established, whether by using manufacturers’ recommendations, risk assessment or equipment history. Follow up questions may be around the process used to determine the frequency and then assess whether the frequency is adequate (i.e. return calls). (Oct. 2010)|
|Q. For years, The Joint Commission has allowed a variety of mechanisms for determining inspection periods and procedures. Most medical equipment management programs either follow manufacturers' recommendations or use a risk factor calculation to determine whether to have semiannual, annual, or no scheduled inspections. Could you describe some successful alternative programs that you have seen?|
|A. Before you can get to frequencies you need to define the maintenance strategies (see EC.02.04.01 EP 3). For example, assume you choose to apply reliability-centered maintenance to a population of devices. With no history to start, the organizations would follow manufacturers’ recommendations as they develop history related to the reliability of the device. Perhaps the manufacturers’ recommendations are to perform X quarterly and Y semiannually. Your experience is that when the quarterly task is done there was not any identified benefit, so you decide to extend the quarterly to semiannually. On the semiannual you find no benefit and decided to move that to annual. Next you monitor the reliability of the device for the next few cycles, ensuring that the extended frequencies are appropriate. As you can see, the maintenance strategy sets up the frequencies. In this example, you began with manufacturers’ recommendations, gathered hospital experience, and adjusted accordingly, monitoring to measure risk. (see EC.02.04.01 EP 4). (Feb. 2011)|
|Q. Regarding risk factor calculations, there are many, many published formulas from which to choose. Presumably, someone could derive his/her own, new formula, too. This seems to be quite arbitrary. Do you have some recommendations? Are you concerned that different formulas will have different results for which equipment to include? Do you have a favorite formula?|
|A. The potential “arbitrary” methods is one of the reasons Joint Commission surveyors will begin to question how you set up your risk-based inventory, looking for indicators that the outcome of the process is continued equipment reliability. Generally the various published formulas and methods arrive at the same conclusions. I remember when the model developed years ago by L. Fennigkoh & B. Smith was introduced. It seemed to meet the needs of sorting equipment based on criteria and risk, was rational and my staff understood its intent which helped in implementation. Others have created complex models that also seem to work well. In assessing the various models you may want to try a few formulas on known devices to see how consistently they all score the same device out. (Feb. 2011)|
|Q. What is expected in a completed preventive maintenance report or work order, regarding procedure steps? How specific must the preventive maintenance report be regarding electrical safety, performance measurements, etc.?|
|A. The information should be available, where that information is stored is up to the organizations. Many organizations have an executive summary for review, and if a Surveyor asks about a specific device the organization can retrieve the specific device history, Preventive Maintenance (PM) activities, PM history, etc. (Feb. 2011)|
|Q. To what extent should preventive maintenance completions be documented, from a minimum of "PM completed" to a description of every step and measurement?|
|A. The information should be available; where that information is stored is up to the organization. If you are asking about documentation related to the clinical engineer completing a work order (WO), it is up to the organization to define. You might have the clinical engineer log the WO as complete electronically, with complete being equal to the PM requirements associated with the WO. Some have the work to be done listed on the WO, with the clinical engineer initialing each activity as it is completed, and retaining the hard copy. It really is up to the organization to define. During a survey, the surveyor may ask about a specific WO associated with the device, and it would then be up to the organization to retrieve the specific device history with the specific PM activities. (May 2011)|
|Q. I’d like to follow up on a previous question related to setting PM rates for organizations accredited by The Joint Commission, and the evidence or supporting documentation that The Joint Commission would be looking for during an inspection. You had noted that surveyors would be asking “staff” how the scheduled activities have been established, whether by using manufacturers’ recommendations, risk assessment or equipment history. And that follow-up questions might be related to the process used to determine the frequency, and then assess whether the frequency is adequate. My question is, in this instance is “staff” referring to biomed/CE staff, clinical staff, or both?|
|A. Medical Equipment Inventory and Maintenance strategies may be discussed with staff, which includes biomed/CE staff. Equipment users may be asked reliability questions, clinical intervention questions, how do they know the device is safe to use, etc. (Feb. 2011)|
|Q. As a QA/RA manager in medical device manufacturing, I would like to ask a question concerning medical devices that do not require any routine calibration or maintenance. What is the current acceptable practice in healthcare facilities for medical devices (pulse oximeters and other similar monitoring devices) of this type? Is there any periodic general review or evaluation of general performance? And if so, how often is this task performed?|
|A. One of two methods may apply to this question. First, are these in the non-life support inventory of equipment that benefits from preventive maintenance, and if so, has the organization followed their established policy for maintaining these? Second, if these are not on the inventory, then it is up to the organization to determine general and routine service, and who performs these tasks. For example, does central sterile clean the device after patient use, or are they cleaned by the users after each use? These processes should be defined by the organization. (May 2011)|
|Q. AAMI and AORN are stating that all mechanical cleaning equipment used for cleaning medical items has to be tested at least weekly (ST 79; 220.127.116.11 Mechanical cleaning). This standard dove tails into The Joint Commission standard E.C.6.20—All medical equipment must be maintained, tested and inspected. How are you applying this standard to the cleaning equipment used in the Sterile Processing departments (automatic washer, sonic, etc.)? What records will you look at? What tests will be accepted?|
|A. 18.104.22.168 specifically refers to: Mechanical cleaning equipment includes utensil washers and cart washers, washer-sanitizers, pasteurization equipment, washer-disinfectors, washer-decontaminators, and washer-sterilizers. It does not specify what type of documentation is required. The Joint Commission will evaluate based on the organization policies. (Oct. 2010)|
|Q. When a hospital adopts a time-related shelf-life system, as stated in AAMI ST79, What formula or guidelines can be used to determine the expiration date of the sterilized items?|
|A. In ST79, there is a recommendation about an event-related system. ST79 does not specify how to “operationalize” a time-related system, however. The Joint Commission would expect you to create guidance policies for your organization. (May 2011)|
|STICKERS ON EQUIPMENT|
|Q. Is there any requirement to use inspections stickers on biomedical devices? They can be very confusing for clinical staff who only look at them when asked if their equipment is safe for use. The inspection sticker has been used for ages to indicate equipment that is included in a scheduled maintenance program. Has anyone got a regulation or standard other than "it has always been done this way?”|
|A. The short answer is that there is not any requirement by The Joint Commission or other agency that I am aware of requiring stickers on medical equipment. It is up to the organizations to define and evaluate the process if in use. The Joint Commission evaluates based on the organization’s policy. The organization has the ability to evaluate the use or non-use of stickers. This process could be evaluated using any of the process evaluation tools available today. (May 2011)|
|Q. There are apparently no new standards or EPs for medical equipment management for 2011. However, can you tell us what might be new areas or issues about which surveyors might be asking?|
|A. Joint Commission Life Safety Code surveyors received training specific to EC.02.04.01 EPs 1–4 at the beginning of the year. A theme I have been using is “Back to the Basics” as I go out and speak and write articles. The four EPs I mentioned really bring us back to our program roots. Many biomed managers inherited their medical equipment inventory when they started at their hospital, and have never edited it. That might be a good place for a surveyor to start. You should be able to explain how the inventory was created, what maintenance strategies you use and examples, how you established preventive maintenance frequencies. (Feb. 2011)|
|Q. My facility has just successfully completed a Joint Commission visit, and while we were doing some housekeeping I advised that we do away with any and all radios in our OR's. My question is, are there any approved radio/stereo systems that are safe to use in a high-risk area such as the OR?|
|A. The Joint Commission does not have a restriction on radios in the operating rooms. As with any device, a radio should be electrically safe (either grounded or double insulated), not directly affecting patient care and not a risk to overloading electrical circuits. From a clinical perspective, ensure that alarms and other sounds are not obstructed by the sounds from the radio and the surgical team is not distracted. (May 2011)|
|Q. If a hospital is using x-ray detectable towels, are they required to be counted, or are they only required to count them if they are at the surgical site? Are hospitals required to count towels (with or without x-ray detectable elements) if they are at the surgical site?|
|A. IC.01.05.01 EP 1 requires use of relevant scientific guidelines when formulating IC processes. AORN’s RPs would be considered one example of such guidelines, which considers radiopaque sponges to be an adjunct to, but not a substitute for an accurate sponge count. This would also apply to towels as you described. (May 2011)|