In December 2010, The Joint Commission (TJC) approved its revised national patient safety goal (NPSG) for medication reconciliation with effective evaluating and scoring scheduled to begin July 1, 2011. As a much anticipated revision, the most immediately noticeable and beneficial aspect of the new goal—NPSG.03.06.01—for the hospital industry is that it has been streamlined and distilled into one safety goal, equivalent to one standard, as opposed to the four, individually scored safety goals contained in the previous iteration. In effect, the entirety of Goal 8 and its related elements of performance have been replaced by NPSG.03.06.01. The new safety goal comprises five elements of performance (EPs) that succinctly capture the bulk of the expectations found in the previous version. However, noticeably absent in the new goal is any mention of medication reconciliation at the time of patient transfer in level of care within a hospital, a requirement previously captured under NPSG.08.01.01, EP 4. It is not known exactly why this requirement was dropped, but TJC did conduct an extensive field review among hospitals and professional associations prior to publishing the revised safety goal. This deletion may have been due to a perception that coordination of care requirements are already adequately addressed in the Provision of Care chapter of the accreditation manual.
The Elements of Performance
The purpose of this goal and its EPs is to maintain and communicate accurate patient medication information to all relevant parties. The five elements attempt to facilitate this purpose and are broken down accordingly.
Element of Performance 1
The first EP for the new safety goal restates the prior expectation of obtaining information about medication usage when a patient is admitted to the hospital or is served in an outpatient setting of the hospital. What differs from the prior goal is the lack of specific details about what minimum information must be captured, such as dose, route, and frequency. Instead, TJC has indicated that the information collected should be documented in a list or other format that is readily useful to those who manage medications. As such, hospitals should assume that dose, route, and frequency are pertinent data fields for any setting where these medications may have to be prescribed, such as an inpatient admission. Although not mandated by this safety goal, many organizations choose to document the time the last dose was taken and the reason for use for each medication. Documenting dose time helps determine when the next dose of a routine medication should be administered and the reason for use can be used to help validate the name of a medication a patient may have reported incorrectly. Outpatient data element requirements are detailed under EP 2.
The first EP has two explanatory notes attached to it. The first note states that the list must contain both scheduled and PRN medications. The second note states that a “good faith effort” must be made to obtain medication information from a patient. In the earlier version of the safety goal, this mandate proved problematic and resulted in requirements for improvement (RFI) when staff left portions of their medication reconciliation list blank. Blank spaces at this stage often lead surveyors to assume no one attempted to ascertain the information. Therefore, it is recommended that any information the patient cannot recall be documented as “unable to recall” instead of simply leaving a blank space on the form.
Element of Performance 2
Interestingly, the second EP allows the hospital to define for itself the minimum amount of medication information that must be captured in non-24-hour settings. Such TJC-indicated settings include the emergency room, primary care areas, outpatient radiology, ambulatory surgery, and diagnostic settings. The minimums for these areas may differ from one another as well. This EP is conceptually similar to what had been the attempted definition under the “minimal use setting” EP in the previous version. This new flexibility should be very well received, particularly in ambulatory care settings where clinicians attempt a very focused reconciliation to identify drugs that may cause concern given the nature of the planned procedure.
An example of the controversy surrounding this arose last year in radiology settings when staff wanted to identify certain oral hypoglycemic medications that were known to interact with IV contrast. Some individuals used the term “reverse reconciliation,” ie, where instead of making a list, a member of the radiology staff would ask very focused questions about the patient’s use of oral hypoglycemics only. It appears as though the new EP 2 creates some flexibility for staff to use unique methods of reconciling medications, including the use of reverse reconciliation where known offending drugs are sought out. Regardless, bear in mind that TJC can always impugn this flexibility by stating in a forum such as their FAQ section that this was not really the intention. At this time, however, there are no FAQs published by TJC for the new medication reconciliation safety goal. Nevertheless, continue to monitor for such updates as the year progresses.
Element of Performance 3
The third EP involves taking action once the list of required information points has been documented. This was the most problematic area of the earlier version of the safety goal. The third EP states that the medication information obtained from a patient must be compared with the medications ordered for that patient to “identify and resolve discrepancies.” Unfortunately, inasmuch as many hospitals struggled with this EP under the previous safety goal, the new version has not made things easier. This EP requires that if a list of medications is obtained from a patient, each medication must be addressed in relation to proposed treatment. For example, it must be clear that changes to a dose or the cessation of prescribing a chronic care medication were intentional decisions in response to that medication reconciliation. TJC does not view an absence of prescribing as automatically indicating a decision was made to not prescribe. Rather, it may have been an error of omission.
As a way to address this issue, hospitals that use their medication reconciliation list as an order form, allowing the physician to document decision making on each drug, can use that same form to fulfill the documentation expectation. Hospitals that do not use their medication reconciliation list as an order form are advised to document decision making in a progress note if one or more medications are going to be changed or discontinued upon admission.
A second significant issue with this requirement is the presence of discrepant information on different lists. This EP will not be considered successful if the medication reconciliation list documents one set of medications and the history and physical results document a second and different list. EP 3 requires the containment and reconciliation of all information about a medication regimen, which will likely lead to the largest number of RFIs upon survey under the new safety goal.
Element of Performance 4
The fourth EP requires the hospital to provide the patient and/or family with a list of prescribed medications upon discharge from an inpatient hospital or at the end of an outpatient encounter, including name, dose, route, frequency, and purpose. Including the purpose of a medication can be very useful for patient education, but stating this as an example of the information that should be provided to the patient is a new expectation, and one that may cause some confusion. Since EP 2 allows the hospital to define the minimum data fields about medications that should be captured in non-24-hour settings, it is likely that hospitals will only be able to provide that same minimum information upon discharge from an ambulatory encounter—not including dose, route, frequency, and purpose, if that information was not obtained at the beginning of the encounter. In addition, EP 4 includes a second concept from the minimal use portion of the previous safety goal that allows a hospital to supply the patient with just their new short-term medication(s) in a list, if nothing else has been changed. For example, after an ambulatory surgery encounter, the physician might prescribe an analgesic or antibiotic for short-term use, not effecting chronic care medications. The list of short-term medications and advice about their safe use could be provided in a preprinted format rather than having to add those new medications to a master list of all medications.
Element of Performance 5
The fifth and last EP establishes a requirement to explain to the patient the importance of managing medication information upon discharge. The note attached to this EP states as an example that the patient should be educated and directed to provide the list to their primary care physician and to update their own list as doses are changed and new medications are added, including additional over-the-counter medications. This education can and will be very valuable, but hospitals need to consider how they are going to document that this process has been performed. At this time, TJC has not identified any EP categories such as A or C, or a mandatory D for documentation. Whether this will be assigned a D for mandatory documentation is still unclear, but I strongly suggest the education be documented. During a patient tracer it is likely that a patient or family member will be interviewed and if the surveyor asks about medication-use education, it is possible the patient will not recall the nature and/or extent of that conversation. Documenting that discussion in the medical record, including as many details as possible, can help mitigate RFIs in this area. Relying only on patient memory makes an institution far more vulnerable to RFIs upon survey. Most hospitals today have teaching records, either on paper or in electronic medical records, and any discharge education could be documented there. An even easier solution would be to have the patient sign the discharge reconciliation form indicating the receipt of a medication list and that the list has been explained. By retaining a copy of that signed discharge reconciliation list, documentation of effort can be readily provided.
TJC references three other standards in this EP (MM.06.01.03, PC.02.03.01, and PC.04.01.05) pertaining to medication education under the self-administration standard and discharge education. The self-administration standard, MM.06.01.03, is potentially problematic in that it states the need for education about side effects, monitoring, reasons for use, and competence to self-administer medications. Previously, this detailed requirement was only called into use for inpatients who were self-administering medications. This standard details some very exacting educational requirements that hospitals should evaluate as discharge reconciliation processes are designed. A significant requirement has been removed from this stage in the process, as the hospital is no longer required to directly send discharge medication reconciliation information to primary care physicians. EP 5 places a degree of responsibility on patients by requiring they bring their medication lists to their doctors at the next visit.
Given the qualitative nature of medication reconciliation and considering the number and range of variables that are part of this information gathering, it is unlikely there will ever be an ideal resolution for this process. Electronic and automated systems certainly will help in the organization and manipulation of medication-use data; however, it is the acquisition and transmission of that data that can be problematic. Nonetheless, TJC has taken strides to allow hospitals to define their own approach to medication reconciliation, thereby facilitating greater adherence to that approach.
The next step will be for surveyors to receive training on how to evaluate this new safety goal for survey scoring set to resume in July 2011. This restart may begin to identify new problem areas, performance lapses, or areas of ambiguity which will result in further guidance to surveyors and accredited organizations through TJC’s FAQs posted to their Web site or through articles in their newsletter—Perspectives. For now, the revised medication reconciliation safety goal appears to add a level of flexibility for hospitals to design their own process, which did not exist in the previous iteration of the goal.
Kurt A. 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 1997 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 bachelor’s degree in pharmacy and his master’s degree in institutional administration from St. John’s University.
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