The Joint Commission’s medication management standards have remained relatively unchanged since 2004. Many of the concepts in the standards have been well described in Joint Commission (TJC) and Centers for Medicare and Medicaid Services requirements for more than 30 years. The standards are familiar, clear, and objective; however, the medication management standards remain one of the more frequently scored items in hospital surveys. Clearly, additional efforts are needed to remedy hospitals’ persistent difficulty in gaining compliance.
Reasons for Survey Scoring
There are three common mistakes hospitals make that lead to requirements for improvement. The first, and perhaps most problematic error, is a failure to thoroughly examine medication management practices in every corner of the hospital organization. All areas—⎯including procedural settings, operating rooms, hospital-owned physician practices, and ambulatory care settings⎯—must precisely follow the hospital’s medication management policies.
The second error is a failure to accurately self-assess performance prior to survey. As a standard practice, hospital pharmacists and technicians routinely inspect medication storage areas and maintain records of these inspections, but surveyors are still uncovering flaws. Employing TJC’s technique of using tracers can be helpful in correcting these procedural flaws. The tracer patient is typically representative of the most common type of patients treated at the facility, so if the facility specializes in oncology, the selected patient would be expected to have a cancer diagnosis. A systematic, thorough review of medication management standards through this internal tracer analysis will yield valuable hospital deficiency information that can be remedied prior to a TJC inspection.
The third common point of error is a failure to create comprehensive policies or a failure to structure those policies to match the actual practices performed in the hospital. Writing policies that are inconsistent with practice is a clear obstacle to success. Rather than create an idealized SOP reflecting what a larger or more technologically advanced facility would do, create an SOP that reflects what your facility does and is capable of doing. TJC expects that facilities not only fulfill expectations, but also consistently follow their own policies and procedures.
Ensuring Compliance with Challenging Standards
Medication management standard MM.03.01.01, which sets requirements for safe medication storage, has been one of the most frequently scored since it was first published in 2004, and one-third of hospitals currently score noncompliant. Highlighting the difficulty of this standard, TJC published its first ever, supplemental booster pack—a detailed explanation of all the nuances required to understand this standard. Given that TJC has gone to great lengths to make sure facilities are aware of and understand the safe storage requirement, what is causing one-third of hospitals to remain noncompliant?
One reason for this trend may be due to the complexity of the standard and its 11 different elements of performance (EPs), but facilities can address the most frequently scored areas in advance. The medication security issue is reflected in EPs 3 and 6. EP 3 requires the hospital to store medications securely and in accordance with regulations, while EP 6 requires that medications are stored in a manner that prevents unauthorized persons from having access to them. Although it may seem that these requirements are identical, there is an important distinction. A hospital can be compliant with EP 3 while being noncompliant with EP 6 depending on how the facility’s own policies have been written. State and federal regulations often dictate storage and access requirements, and EP 3 mandates that facilities be compliant with these. EP 6 then raises the issue of being compliant with your own hospital’s policies on who is authorized to have access to medications.
This confusion in internal policies illustrates the problem areas discussed earlier. For example, not fully evaluating security measures in every possible area of the hospital can leave physician practices, procedural areas, and even inpatient units vulnerable to findings if their practices are not compliant with internal policy. In most hospitals, internal policy dictates that all medications are secured through observation or by keeping them locked. But staff at many facilities may not realize that TJC’s definition of medications includes IV solutions, radioisotopes, and contrast media, in addition to other drugs typically understood to be medications. This common misunderstanding often leads facilities to be lax in enforcing the same security requirements for all products. For example, contrast media is sometimes stored in unlocked cabinets in the radiology department; IV solutions are often stored in a clean utility room or on a rolling cart in a treatment area, where they are accessible to all staff—and in theory, patients and visitors as well—because they are not locked or visually secured.
The medication security requirement also can expose inconsistencies between hospital policy and hospital practice as to who is authorized to access medications. It is not uncommon for hospitals to write overly stringent or rigid policies that are not consistent with actual practice. For example, medication security policies often confine those authorized to access medications to nurses, pharmacists, and physicians. Yet in practice, radiology technicians and respiratory therapists often have access to what are considered medications, and central supply or materials management staff members have access to bulk IV solutions. Policies need to be rewritten to reflect consistency with actual practice and standard procedures. When a medication security policy is being developed, first identify all staff that need to have access to any type of medication product, then systematically review the entire storage chain, from purchasing to receipt, distribution to use, and include the return of unneeded, expired, or wasted products. Being thoughtful and thorough during this process should help identify all staff that could potentially come into contact with medication products, and these staff need to be included in the internal policy.
When self-assessing medication security issues, a helpful practice is to imagine that you are the surveyor and are tasked with evaluating safe storage and uncovering deficiencies. If you are unsure about any issue, contact TJC’s standards interpretation group for an expert response, or refer to one of the many publications on medication management and tracer technique developed by TJC’s pharmacy experts and published through their partner organization, Joint Commission Resources.
Temperature Monitoring Compliance
MM.03.01.01 has two additional areas of concern⎯—EP 2 concerning safe storage and EP 8, which covers expired medications. EP 2 addresses medication refrigerators and proper temperature control, and indicates that simply providing written temperature logs and thermometers to monitor temperature is insufficient. Temperatures need to be monitored consistently at least 90% of the time, and staff needs to take timely action if a temperature is out of range and then document what has been done to rectify the situation. The action taken also needs to be consistent with the hospital’s internal policy. If automated temperature monitoring technology is not being used and temperatures are being recorded manually, the paper form can be structured with shaded areas to highlight the out-of-range temperature that needs to be addressed. When deciding how to appropriately remedy the alert, pharmacy needs to consider individual medication storage requirements, since some medications might need to be destroyed if exposed to out-of-range temperatures, while others can still be used. Any paper forms should be constructed to outline the policy expectation and make it simple to document actions taken.
In recent years, the advent of automated temperature monitoring has improved compliance in this area, but if such a system has been implemented, the hospital still needs to ensure clearly defined methods for notification and document actions taken. Also, make sure areas of the hospital that are not open 24/7 have the necessary tools to efficiently resolve refrigerator temperature issues that occur when those areas are closed. For instance, in ambulatory care settings, make sure staff have received the necessary system training, can read high/low temperatures, and can reset the system when the clinic reopens.
The other common problem area involves storage of medication products at elevated temperatures, which is sometimes done with IV fluids, irrigating fluids, contrast media, and mannitol. Any prolonged storage at an elevated temperature has to be done in accordance with the manufacturer’s guidance for temperature and duration maximums, and a system needs to be in place to clearly delineate that these products are not to be stored beyond those maximums. In other words, a system is necessary to establish and implement beyond use dates for these conditions.
Reconciling Expired Medications
The issue of expired medications, covered under EP 8, has been a particularly difficult problem for decades because not every corner of the hospital is adequately inspected. While most official storage locations are inspected by pharmacy staff during monthly inspections, many facilities also have unofficial or unapproved storage locations that will be inspected by TJC surveyors. The increased use of automated dispensing cabinets in official storage locations has improved tracking of expired drugs, but unofficial storage locations still require additional oversight. For example, staff might retrieve a medication for a procedure from an ADC and bring the drug into a procedure room. After the procedure is complete, if the medication has not been used or has only been partially used, staff might decide to place it in a drawer in the procedure area for use on a future case. Hospital policy usually states that unused doses should be returned to the ADC or the returns bin and partially used doses are to be disposed of, but returning a dose is often viewed as too labor intensive and discarding a partial dose is viewed as wasteful, so medications are sometimes placed where they should not be. During a tracer, TJC surveyors will open all drawers and cabinets in procedure areas, and they often find expired products therein. Hospitals should proactively inspect for expired medications in such locations and modify practices to discourage such activity.
When addressing medication expirations, take care to properly date multidose vials. TJC expects hospitals to establish a beyond use date for every open multidose vial and to adhere to that date. Some hospitals are not aware that using the date of opening, with a 28-day discard policy, is now insufficient for dating multidose vials; the date on the vial must be the beyond use date, not the date of opening. Use a thorough self-assessment to verify that staff perform this task correctly 90% of the time or better. Oftentimes, TJC finds that multidose vials are not dated with an expiration date, or that expired vials remain available for use. If a facility is experiencing this issue, it should be resolved prior to survey by developing an alternative method. One approach is to establish an expiration date based on the date of dispensing rather than the date of opening, as this solution involves fewer staff members and follows one uniform procedure, thereby ensuring a higher success rate.
Reviewing New Medication Orders
There are two other standards in this chapter that are frequently scored—⎯MM.04.01.01 and MM.05.01.01. While the EPs are different in these two standards, the failed process usually is the same⎯—specifically, a failure to thoroughly review new medication orders for clarity and compliance with hospital policies. MM.04.01.01 addresses requirements for range and PRN orders; range orders must state clearly when to administer the higher dose and when to administer the lower dose, and each PRN order must have an indication for use associated with the order.
EP 8 in MM.05.01.01 requires analysis of new medication orders to screen out therapeutic duplication, but the failure rate for not noticing a missing PRN indication, an unclear range order, or two medications for the same indication, remains high. When these orders are processed by pharmacy staff, before entering the order into the computer system, pharmacy should intervene with the prescriber to obtain any missing information.
The Key to Compliance: Thorough Internal Self-Assessment
Instituting accurate and rigorous internal self-assessment is key to avoiding survey problems. TJC has a highly structured format for its standards, with different EP types and icons for measurement and documentation. Accordingly, hospital pharmacy leaders must become expert in understanding the terminology and standards format. There are 19 mandatory policies requiring documentation in the medication management chapter alone, and all of these need to be addressed. Performing a word search to verify that your hospital’s policy wording precisely addresses the EP requirement can be a valuable step. After creating the policy, ensure that staff is adhering to it using hard data that verifies compliance. Most likely, you will find performance areas where compliance is less than the required 90%. If that is the case, these problems need to be addressed and resolved immediately.
Perform a rigorous self-assessment to ensure that qualitative aspects of the requirements are being met. For example, it is common for hospitals to audit medical records looking for the form documenting that medication reconciliation has been performed. Go one step further and validate that discrepancies have been resolved as well: Have all the medications the patient self-reported been addressed? Is it clear that decisions were made to prescribe or not prescribe medications based on this information? Are there discrepancies between medications listed on the chart versus what is listed in the patient’s history? Remember, the presence of the medication reconciliation form alone does not indicate that an action has occurred.
Ultimately, do not be misled into thinking that some parts of the hospital do not fall under pharmacy’s purview for effectively implementing medication management standards. If the area is owned and operated by the hospital, or functionally and organizationally integrated, it is subject to review under these standards. As the arbiter of drug safety, the buck stops at pharmacy when medication management issues are being addressed.
Kurt Patton, MS, RPh, is owner of Patton Healthcare Consulting, LLC, an accreditation, regulatory compliance, and patient safety consulting company. He served as executive director of accreditation services at TJC from 1998 to 2005. Before joining TJC, Kurt was deputy director for the division of strategic initiatives and managed care in the New York State office of mental health. He earned his bachelors degree in pharmacy and his masters degree in institutional administration from St. John’s University.
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