Q&A with Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP; Practice Leader, Medication Safety, Joint Commission Resources
Pharmacy Purchasing & Products: What significant compliance challenges has the Joint Commission identified recently?
Jeannell M. Mansur: As in previous years, Storage and Security of Medications (MM.03.01.01) tops the list; 34.7% of organizations were noncompliant with this standard last year. Other challenging standards include MM.04.01.01 Medication Orders (22.4% noncompliant), MM.05.01.01 Medication Order Review (15.7% noncompliant), and National Patient Safety Goal (NPSG) NPSG.03.04.01 Labeling in OR/Procedures (13% noncompliant). (See TABLE 1 for additional challenging standards.)
Most importantly, surveyors want to see that the individual who is recording the temperatures recognizes when refrigerators are out of range and is aware of what steps to take should this occur. Staff assigned to assess and record temperatures should be trained on what actions are required when temperatures are out of range, and clear processes should be defined as to when to call those responsible for refrigerator maintenance and when to contact the pharmacist to assess the status of any affected medications.
When medications are warmed, temperatures of warmers must be tracked similarly to refrigerator temperatures. Often, shelf life changes when medications are warmed; therefore, manufacturer data should be used to define revised beyond-use dating, and revised dates should be placed on the warmed medications.
Another requirement of MM.03.01.01 pertains to medication security. Only authorized individuals should have access to medications. Surveyors are looking specifically for unsecured medications. As such, drugs must not be left on countertops or on medication carts where patients or family members could gain access. Facilities must determine which staff members require medication access, how that access should be provided, and the process for revoking authorization. For example, what is the process and timeline for removing ADC passwords from the system when a staff member resigns?
In addition, hospital pharmacists should be aware that the use of non-profiled ADCs is a red flag to Joint Commission surveyors. It is not enough to have the capability to profile ADCs; the profile function must be turned on to prevent users from obtaining medications prior to a pharmacist’s review of the order. If a nonprofiled ADC is in use, the surveyor may query whether all medications removed would qualify as urgently needed, or that an LIP would be available at the bedside during medication administration. Finally, surveyors may wish to understand your organization’s strategy for monitoring and managing overrides—eg, what is the override rate? How are issues with use of the override function identified? How have you addressed performance issues? Too few facilities have a robust process for managing overrides.
A process for reviewing overrides should first and foremost be able to confirm that the override process was used appropriately; it should be able to assess whether the medication was truly needed urgently or was administered with an LIP at the bedside. This can be difficult to determine by those not familiar with events taking place on the patient care unit. For this reason, it is recommended that those who are familiar with the activities in the unit, typically nursing managers, be involved in reviewing override data.
PP&P: Which non–medication management standards should pharmacists be aware of?
Mansur: Life Safety Code LS.02.01.20 is one of the standards for which facilities are most frequently cited. This standard discusses corridor clutter and applies to medication carts and computers on wheels, which often are left in hallways for extended periods of time. Keeping the corridors free for egress is a fire safety issue; thus, unused carts and computers on wheels are permitted to remain in hallways for 30 minutes only.
Hospitals also are frequently cited for noncompliance with LD.04.03.09, a leadership standard pertaining to contracted services, wherein the vendor’s service will be provided directly to patients. This is a concern for pharmacy as it encompasses outsourced compounding for patient-specific medications, such as patient-specific TPNs, as well as patient-specific radiopharmaceuticals that are supplied by an outside nuclear pharmacy. The standard includes requirements detailing who should be involved in the vendor selection process and stipulates that contracts include performance measures to be used by the organization to evaluate the vendor’s performance over the life of the contract. One reason that hospitals frequently are cited for noncompliance with LD.04.03.09 is that many organizations have worked with the same vendors for years; hence, the contracts were written long ago and have not been updated to include performance measures. Keep in mind that most surveyors will ask for a list of contracted services at the outset of the survey. The surveyor is also likely to review specific contracts from that list to ensure they have been updated to reflect the new requirements. As such, these contracts should be reviewed for compliance and a copy included in the organization’s survey preparation file.
Pharmacists should be aware that there are many standards in chapters outside of the medication management chapter that could have relevance to their practices or departments, including human resource requirements, environment of care requirements, and provision of care requirements.
PP&P: What additional issues are on the Joint Commission’s radar?
Mansur: Three issues we are currently focusing on are: clinical alarm management, sample medication management, and proper use of single-dose vials.
Implementation of this standard is phased. Phase 1 began January 1, 2014, requiring hospitals to establish alarm safety as an organizational priority and identify the most important alarms at their facilities. To this end, health care professionals were instructed to solicit input from medical staff and clinical departments; determine the risk to patients from a lack of response or device malfunction; determine if, and identify which, specific alarms are contributing to noise/alert fatigue; evaluate the potential for patient harm based on internal incident history; and identify published best practices/guidelines. While it is up to the organization to identify the alarms they consider most important, the Joint Commission has determined that alerts within the EMR systems are not considered alarms, but rather clinical decision support tools. We expect the focus to be on alarms that are directly connected to the patient, such as infusion pump alarms.
Phase 2 will begin January 1, 2016, and will require hospitals to develop and implement specific components of P&Ps and educate staff about alarm system management. Components of comprehensive P&Ps should include clinically appropriate settings, when alarms can be disabled, when parameters can be changed, who is permitted to adjust alarms, monitoring and response expectations, and a schedule for checking individual alarm signals for accurate settings and proper operation. Organizations should consider creating a working group of stakeholders, including nurses, pharmacists, and physicians, to develop a strategy for meeting the new requirements.
To be clear, the Joint Commission does not endorse nor prohibit the use of sample medications; the new notes are meant only to identify those medication management EPs that are applicable to sample medications in organizations that allow their use. Taking a proactive approach to medication samples is suggested; organizations should decide if and when samples will be used and which samples will be permitted, rather than allow pharmaceutical representatives to drop off samples with no management plan in place.
If your hospital permits the use of sample medications, developing a P&P regarding their use is strongly recommended. Although not a requirement, it is prudent to develop a policy that addresses safe storage, labeling, documentation, and access. The P&P should be shared internally so all staff members are aware of the hospital’s policy and with pharmaceutical representatives so they have the information they need to be in compliance with your hospital’s P&P. Considerations include:
PP&P: What areas of improvement did surveyors note this year?
Mansur: One area of improvement this year is in compliance with medication reconciliation requirements. Prior to the Joint Commission’s revision of the medication reconciliation NPSG in December 2010, noncompliance rates were about 18% to 21%; medication reconciliation noncompliance rates in 2014 are about 5.8%. Many organizations have demonstrated considerable effort in improving medication reconciliation in recent years, and it has shown in recent surveys.
In the past, the Joint Commission introduced significant changes in the chapters on a yearly basis. Now the Joint Commission has made a concerted effort to slow the pace of change, which gives organizations time to learn, adapt, and comply with the requirements.
PP&P: What issues are currently subjects of Joint Commission deliberation?
Mansur: With the highly publicized safety issues relating to sterile admixture compounding, compounding safety is at the forefront of the Joint Commission’s deliberations, as is the survey process surrounding compounding. Although the Joint Commission does not have specific requirements for compliance with the details of USP <797>, there are standards requiring aseptic training for those who compound, and discussions are occurring internally regarding compounding safety and the survey process. In fact, homecare surveyors are receiving additional training to help them assess sterile compounding areas. This may impact the survey process for hospital surveyors as well, but no final decisions have been made.
PP&P: What resources are available to assist organizations in preparing for a Joint Commission inspection?
Mansur: A number of Joint Commission Resources (JCR) publications are available, as are resources from ASHP. In fact, JCR and ASHP co-published a handbook on medication storage in 2009 that is still an excellent resource.3 The Joint Commission continues to publish booster packs on challenging standards; several years ago we published an important booster pack on medication storage and security.4 In addition, changes to standards are announced through the newsletter, Perspectives, so I would encourage PP&P readers to make sure they are on the distribution list for this publication.5
Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP, is practice leader for medication safety for Joint Commission Resources and Joint Commission International. She provides direction to hospital leaders on medication safety design, medication system optimization, and technology implementation to support patient safety and effectiveness. Jeannell received a BS in pharmacy from the University of Michigan and a doctor of pharmacy from Wayne State University in Detroit.
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