Pharmacy Purchasing & Products: What significant medication management (MM) and National Patient Safety Goal (NPSG) compliance challenges has The Joint Commission identified recently?

Jeannell M. Mansur: The most significant compliance challenges observed this year are similar to those noted in recent years (see TABLE 1). Storage and security of medications (MM.03.01.01) is again the most frequently problematic standard, with 33.7% of hospitals noncompliant, followed closely by medication orders (30% noncompliant). Medication order review (MM.05.01.01) also was challenging for hospitals, with 15% scoring noncompliant, as was labeling in the operating room (OR)/procedures, with 10% noncompliant. Fewer than 6% of hospitals were noncompliant with preparing medications (MM.05.01.07), reconciling medications (NPSG.03.06.01), labeling medications (MM.05.01.09), look-alike/sound-alike medications (MM.01.02.01), and high-alert/hazardous medications (MM.01.01.03).

MM.03.01.01 Storage and Security of Medications. Consistent with previous years, a common reason for noncompliance with the storage and security of medications standard is failure to store all medications in secure locations to prevent access to non-authorized individuals. They are also looking for a timely removal of departed employees from access to automated dispensing cabinets (ADCs). In the last several years, there has been more focus on controlled substance management. Joint Commission surveyors are requesting information from hospitals detailing their policies and procedures (P&Ps) to ensure adequate control and to prevent diversion, investigating compliance with these P&Ps, and asking for documentation.

Ensuring that refrigerated medications are stored at the correct temperature also is a concern. Specifically, surveyors seek to verify that staff properly responds to out-of-range temperatures. Compliance with the standard is more than a matter of documentation; staff must know what steps to take when a refrigerator is out of range and perform these duties.

Other significant issues identified at survey include failure to remove expired medications and failure to properly date multi-dose vials.

MM.04.01.01 Medication Orders. Interestingly, more hospitals were noncompliant with medication orders in 2015 than in 2014—30% versus 25%, respectively. Surveyors are noting significant hospital noncompliance with P&Ps related to the elements of participation (EPs) for MM.04.01.01, particularly for titration medications, which have become a new area of focus. Titration orders—which must be adjusted according to patient response—often do not include the required elements. In addition, titration orders must be written in such a way as to comply with the hospital’s P&Ps, and staff must adhere to these orders as they are written. Titration orders must include sufficient detail to properly guide the nurse who will be adjusting the medication, and surveyors are looking for a strong, specific policy that includes all relevant details—for example, a starting dose, upper limit, and directions detailing how frequently and at what increments nurses can make adjustments. The order should include objective parameters that the nurse uses when making these decisions, and nursing practice must be in accordance with the order. Pharmacy should work with nursing to adjust order sets, if necessary, to ensure they match actual practice.

Another challenge for hospitals is compliance with EP 15, which defines recommendations for standing orders and order sets. Requirements must be clearly specified and developed using nationally recognized, evidence-based guidelines. Medication orders that are initiated by a nurse prior to a licensed independent practitioner (LIP) order require approval by medical staff leadership, pharmacy leadership and nursing leadership. Standing orders should be periodically reviewed to determine continued usefulness and safety. While some standing orders can be created to allow initiation prior to an LIP order, they will need to be eventually signed by an LIP. The timeline for dating, timing and authentication will be directed by state law or hospital policies or bylaws, whichever is shorter.

MM.05.01.01 Medication Order Review. To ensure compliance with this standard, surveyors seek to ensure that a pharmacist reviews orders at all times and in all areas of the hospital where this is required. Multiple choice orders—for example, a common finding is more than one “as needed” orders for pain medications that do not specify when to use one medication versus another. These orders should not be written, but if they are, they must be addressed during the order review process. Surveyors often will visit key areas, such as the post-anesthesia care units (PACUs) and oncology areas, where it is not unusual to see orders for more than one pain medication or more than one medication to treat nausea and vomiting. Ideally, if multiple medication orders for the same indication exist on an as-needed basis, a specification should be included describing when to use one medication versus another.

Proper management of ADC overrides is another medication order concern. Surveyors continue to ask for details about the override process to ensure overrides are being used appropriately.

NPSG.03.04.01 Labeling in OR/Procedures. As an NPSG, compliance with labeling in the OR and procedural areas is mandatory in order to pass a Joint Commission survey. At the present time, surveyors are finding that the labeling process in ORs is embedded in most organizations; however, surveyors are finding noncompliance in procedure areas—particularly for bedside procedures. For example, for a procedure performed in a patient room, the same medication and solution labeling requirements apply as they would in the OR. Because the staff member placing the line often is not a surgeon, who is familiar with this concept from working in the OR, that staff member may not be aware of this requirement.

As such, is it pharmacy’s responsibility to educate nurses and residents about compliance with NPSG.03.04.01 in procedure areas. Oftentimes, nurses are aware of when procedures will take place, and can remind physicians working at the bedside about labeling requirements.

PP&P: What are the new developments in medication management standards?

Mansur: In July 2016, the Joint Commission published a new MM standard (MM.09.01.01), which defines the requirements for antimicrobial stewardship programs (ASPs) for hospitals, critical access hospitals, and nursing care centers (with ambulatory to follow at a later date). The Joint Commission will begin surveying for this standard on January 1, 2017. This comprehensive standard requires the development of an infrastructure to deliver antimicrobial stewardship activities, including teaching elements for health care professionals, patients, and families. The standard also requires protocols and internal data reporting. Specifically, the standard requires the following1:

• Antimicrobial stewardship becomes an established organizational priority
• Hospitals educate staff and LIPs involved in antimicrobial ordering, dispensing, administration, and monitoring about antimicrobial resistance and antimicrobial stewardship practices. In addition, hospitals educate patients and families regarding appropriate antimicrobial use, including antibiotics. Excellent tools are available to assist facilities in these endeavors (see SIDEBAR)
• Hospitals have an antimicrobial stewardship multidisciplinary team that includes an infectious disease physician, infection preventionist(s), pharmacist(s), and practitioners, if available
• The ASP includes the following core elements: leadership commitment, accountability, drug expertise, action, tracking, reporting, and education
• The ASP uses organization-approved multidisciplinary protocols
• The hospital collects, analyzes, and reports data on its ASP
• The hospital takes action on improvement opportunities identified in its ASP

MM.09.01.01 is based on recommendations that were published by the Centers for Disease Control and Prevention (CDC).2 Organizations that have had ASPs in place should review ASP activities against these newly published standards. Some hospitals may find that there are aspects of their ASP that require building, and some hospitals without current ASPs in place, will need to design and implement these activities.

In addition, the author recommends an objective gap analysis to evaluate a hospital’s compliance with the standard’s EPs, followed by a conversation about how the hospital can demonstrate compliance in its ASP.

Click here to see FIGURE 1.

PP&P: What new projects are on the horizon for The Joint Commission?

Mansur: Joint Commission Resources is leading an initiative, sponsored by BD, focusing on assisting organizations with USP Chapter <800> compliance. Tools include a Webinar series (available on demand); a Web-based, self-assessment tool to assess compliance with USP <800> requirements, as well as best practices outside of <800> (at www.hazmedsafety.com); and a toolkit that addresses challenging requirements of USP <800>. All of these resources are available free of charge.

In addition, The Joint Commission is undergoing changes to pre-survey, survey, and post-survey processes as part of Project Refresh. Part of Project Refresh is the Safer Analysis for Evaluating Risk (SAFER) initiative, which will change the scoring of standards during the survey.³ The Joint Commission also has recently announced it will offer a medication compounding certification program designed to enhance the depth and specificity of compounding practice evaluations based on the sterile and non-sterile compounding requirements in USP <795> and <797>.4 Pharmacist surveyors who have undergone specific training in USP compliance will assess compounding compliance. Facilities with pharmacies performing compounding services may elect to pursue this optional certification, which will become available starting in January, 2017 in Michigan, thereafter rolling out to the rest of the country after June, 2017.

PP&P: What points of error have surveyors noted regarding medication reconciliation?

Mansur: Fortunately, compliance with NPSG.03.06.01—Reconciling Medications is markedly improved of late; this year, just 4% of hospitals were noncompliant. This success is undoubtedly due to the considerable work put in by hospitals. Nevertheless, it is important to note that the survey process focuses only on ensuring that medication reconciliation has taken place, a home medication list has been created, and a discharge medication list has been provided to the patient—it is difficult to identify quality issues with medication reconciliation during the survey process.

There are a number of opportunities to improve the quality of the medication reconciliation process. FIGURE 1 illustrates the many areas in the medication reconciliation process where quality issues can arise.

PP&P: How do you suggest organizations commit to ongoing improvement?

Mansur: It is not uncommon for a facility to be cited for the same issues survey after survey. Surveyors see this as indicative of an organization’s inability to effect and sustain change. For change to be sustainable, robust process improvement methods and tools are necessary. Any process improvement methodology—for example, LEAN practices, Six Sigma, Plan-Do-Check-Act—is acceptable, provided it includes gathering stakeholders, investigating factors that impact performance issues, planning improvements based on that analysis, implementing change, and tracking actions to ensure performance remains within defined limits.

PP&P: What changes do you anticipate in the medication management standards over the next few years?

Mansur: The MM chapter has been fairly consistent and has not undergone significant alteration in recent years, but that is about to change. The entire chapter is currently undergoing review, and it is anticipated that phased changes will be announced in 2017. Therefore, pharmacists must keep abreast of Joint Commission announcements moving into next year and thereafter.

References

1. Joint Commission Perspectives. July 2016;36(7). www.jointcommission.org/assets/1/6/New_Antimicrobial_Stewardship_Standard.pdf. Accessed October 5, 2016.
2. CDC Core Elements of Hospital Antimicrobial Stewardship Programs. Get Smart for Healthcare Web site. www.cdc.gov/getsmart/healthcare/implementation/core-elements.html. Accessed October 6, 2016.
3. Project REFRESH and the Survey Analysis for Evaluating Risk (SAFER) Matrix. The Joint Commission Web site. www.jointcommission.org/assets/1/6/webinar_replay_safer_081716.pdf. Accessed November 1, 2016.
4. The Joint Commission Medication Compounding Certification Letter to Valued Customers. The Joint Commission Web site. www.jointcommission.org/assets/1/6/Letter_to_Michigan_organizations.pdf. Accessed October 6, 2016.

Jeannell M. Mansur, RPh, PharmD, FASHP, FSMSO, CJCP, is Principal Consultant for Medication Management and 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.