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: The top Joint Commission compliance issues over the past year are consistent with those of previous years (see TABLE 1). Storage and Security of Medications was the most challenging; 35% of organizations were noncompliant with this standard, followed by Medication Orders (25% noncompliant), Medication Order Review (20% noncompliant), and Labeling in OR/Procedures (13% noncompliant). However, it is important to note that often there are repeat findings on survey reports from year to year. When this happens, it is important to ask the question: If the hospital is taking the required steps to remedy the problem, why is it resurfacing at the next survey? This year’s compliance challenges illustrate that we are not doing enough to affect and sustain improvements.

MM.03.01.01 Storage and Security of Medications. Storing and securing medications continues to challenge more than one-third of hospitals. In the past, surveyors noted that facilities often were noncompliant due to improper monitoring of refrigerator temperatures. Although this remains a finding, surveyors also are citing hospitals for not following manufacturers’ recommendations for storage and use of refrigerated medications. For example, manufacturers recommend storing succinylcholine in the refrigerator to prolong its shelf life. However, in many ORs, this medication is kept at room temperature in anesthesia carts so that it is readily available during procedures. Manufacturers’ recommendations for storing succinylcholine in non-refrigerated conditions may specify a BUD that reflects their testing. However, it is not uncommon for hospitals to attempt to extend BUD using available literature as support. But the Joint Commission has stated that the manufacturer’s recommendation supersedes any found in the literature. As a result, failure to follow manufacturers’ recommendations for BUD is a common cause of noncompliance with MM.03.01.01.

In addition, hospitals may be cited for noncompliance with this standard for failing to comply with their internal controlled substance storage policy and not taking steps to prevent drug diversion. MM.03.01.01 EP 3 states, “The hospital stores all medications and biologicals, including controlled (scheduled) medications, in a secured area to prevent diversion, and locked when necessary, in accordance with law and regulation.” Clearly, drug addiction is a significant societal problem, and hospitals must do their part to prevent controlled substance diversion within their walls. Joint Commission surveyors will inquire as to the steps hospitals are taking to detect and prevent diversion. Drug detection prevention software has become increasingly sophisticated and is highly effective at identifying patterns of potential drug diversion. Although the use of such software is not required, hospitals must have a plan to properly store and account for controlled substances and should be ready to discuss their strategies with surveyors.

MM.04.01.01 Medication Orders. In this category, policies must be developed that describe required elements for medication orders, and surveyors will review compliance with those policies. Often, medication orders do not include the required elements. One example that frequently occurs involves orders for medications that are titrated, or adjusted, according to patient response. Because patients in the ICU are by nature unstable, often with fluctuating blood pressure and levels of consciousness, orders are written to manage the patient’s condition, and the nurse must adjust medications according to patient response. According to the Joint Commission standards, if titration orders are used, the organization must have a policy in place delineating what must be included in the order. For example, hospital policies often require that the prescriber provide details for the nurse, such as a starting dose, maximum dose, and/or parameters that guide how rates of administration can be changed; but upon review, actual orders often are missing pieces of information required by the policy. While the Joint Commission encourages hospitals to develop their own policies, the organization is required to adhere to these policies.

MM.05.01.01 Medication Order Review. Twenty percent of hospitals surveyed are noncompliant with review of medication orders prior to administration, a critical safety net for ensuring medication safety. The Joint Commission MM.05.01.01 states that before a medication is administered, a pharmacist must review all orders (unless the practitioner controls ordering, preparation, and administration of medication or if delay threatens an urgent situation, such as a sudden change in clinical status). Due to the critical nature of this standard, surveyors review this issue carefully and will seek an explanation when medication review is bypassed. For example, surveyors will evaluate how organizations monitor their non-profiled automated dispensing cabinets (ADCs). Moreover, surveyors will review medication override lists; hospitals must be ready to provide a rationale for every medication appearing on the list (eg, medication needed for emergencies). Surveyors may ask, How are you monitoring overrides? What problems have you seen? How have you addressed these problems?

In addition, surveyors have encountered some organizations that use multiple-choice orders, wherein the nurse is left with the clinical decision-making responsibility of determining which medication to administer. Clearly, this role exceeds their licensure. For example, a physician may list several medications to treat nausea without specifying which are first- and second-line treatments. Instead, the order should specify which medication to administer first with instructions to administer the second-line medication only if the patient does not experience sufficient relief. For pain medications, the order could specify that for a pain score of 4 to 6, medication X is to be administered, while a pain score of 7 or higher indicates that medication Y is to be administered.

NPSG.03.04.01 EP 3 Labeling in OR/Procedure Areas. A clarification of wording in this NPSG, effective January 1, 2015, states that in perioperative and other procedural settings, both on and off the sterile field, medication or solution labels should include the following:

• Medication or solution name
• Strength
• Amount of medication or solution containing medication (if not apparent from the container)
• Diluent name and volume (if not apparent from the container)
• Expiration date when not used within 24 hours
• Expiration time when expiration occurs in less than 24 hours
  Note: The date and time are not necessary for short procedures, as defined by the hospital.

Medications in the OR setting often are drawn up and then used repeatedly throughout the procedure; therefore, the initial amount may not be the current amount of medication. As long as the amount is evident from the container—as would be the case for a syringe with markings—there is no need to document the amount or volume of medication in the container.

NPSG.03.06.01 Reconciling Medication Information. Many organizations have made significant improvements in medication reconciliation in recent years. Hospitals are more consistent in collecting home medication information on admission and providing a list of medications for patients to take at home at discharge. Survey results reflect that improvement, with a decline in the number of hospitals surveyed that are found to be noncompliant in meeting medication reconciliation requirements. However, quality issues with the accuracy of the medication lists and the effectiveness of communication with the patient being discharged still exist. Organizations should assess their medication reconciliation process and evaluate the quality of the development of the home medication list, the quality of the reconciliation process, the development of the discharge list, and the effectiveness of the teaching process prior to discharge, to prepare patients to manage their own care at home. Additional tips for improving the quality of medication reconciliation include: automate the process by implementing medication reconciliation software; utilize claims data from community pharmacies; improve medication reconciliation interviewing skills; and increase staff training. A critical assessment of medication reconciliation performance should include:

• Consider carefully who should compile the medication list; medication reconciliation responsibilities must be clearly delineated, and auditing should occur to ensure accountability. To assist in identifying possible issues, consider utilizing two staff members in the process of collecting the medication list.
• When developing a home medication list for discharge, the information on what the patient took prior to admission should be readily available. Directions for using medications that were not continued in the hospital should be provided, as well as for medications that will continue after the hospital stay. Those who make decisions about discharge medications should recognize that patients’ medical insurance might require them to use a different therapeutic equivalent than the hospital uses; it is helpful to confirm that there will be no insurance issues.
• Ensure the patient understands all instructions regarding medications to be taken at home. Keep in mind that discharge teaching should occur throughout the hospital stay; do not save it until the 15 minutes prior to discharge. Consider using supplemental educational tools to support patient understanding, such as written medication information on specific drugs or medication calendars. The teach-back method of instruction is an effective way to confirm that the patient understands the discharge instructions.  

PP&P: What red flags are on the Joint Commission’s radar?
Mansur: While many organizations still manually monitor medication refrigerators, an increasing number of facilities are using central temperature monitoring systems to keep track of temperatures for important refrigerators, such as those storing medication, blood, or tissue specimens. This has greatly facilitated compliance with monitoring requirements. However, it is important that staff knows the correct steps to take when temperatures are out of range. Developing a procedure and ensuring staff members are trained on this procedure, are wise.

Another issue of concern for surveyors is ensuring the safe dispensing of medications (MM.05.01.11), particularly for pediatric patients. MM.05.01.11 EP 4 states that medications are dispensed in the most ready-to-administer form, and, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager. Approximately 25% of those treated in a typical hospital ER are pediatric patients, some of whom are admitted. If the hospital does not have a pediatric unit, they may be admitted to adult nursing floors. Per the Joint Commission, pharmacy must provide all patients with patient-specific doses. However, surveyors recently have seen a number of hospitals sending bulk bottles, rather than exact doses, up to the nursing floor for pediatric patients, which is contrary to the Joint Commission’s requirements. Hospital pharmacies should be dispensing patient-specific doses, rather than sending up bulk bottles of medications.

Yet another red flag for surveyors is employing the auto-verification feature on the CPOE system. Many EHR vendors have collaborated with ADC vendors to create rules whereby certain medications may be accessed from an ADC as a verified order without pharmacist review, provided the physician has ordered the exact dose located in the ADC. However, Joint Commission standard MM.05.01.01 EP 1 requires a pharmacist to review medications (with certain exceptions) prior to administration. Therefore, organizations should not be using automatic verification of medications in areas or circumstances in which pharmacist review of the medication order is required. The Joint Commission does not consider auto-verification to be an acceptable alternative to pharmacist review.

PP&P: What recent sentinel event alerts (SEAs) should pharmacists be aware of?
Mansur: First of all, pharmacists should understand the importance of the Joint Commission’s SEA publications. Per the Joint Commission:

“An SEA identifies specific types of sentinel and adverse event and high-risk conditions, describes their common underlying causes, and recommends   steps to reduce risk and prevent future occurrences. Joint Commission-accredited organizations should consider information in an SEA when designing or   redesigning processes and consider implementing relevant suggestions contained in the alert or reasonable alternatives.”¹

As such, SEAs are not surveyable; they are intended only to provide information and assistance to health care facilities. The Joint Commission requirements are not announced in SEAs, but are available in standards and in the Joint Commission publication, Perspectives.² However, it should be noted that SEAs are valuable sources, not only of information on issues that pose significant risk and harm to patients, but also of practical recommendations for how to address issues.

Recent SEAs of note include:

SEA 52: Preventing Infection from the Misuse of Vials.³ Released on June 16, 2014, SEA 52 focuses primarily on the misuse of single-dose vials (SDVs), although multiple-dose vials (MDVs) also are addressed. SDVs may be misused due to lack of knowledge/education, negligence, inability to identify an SDV/MDV, drug shortages, attempts to save costs and reduce waste, and convenience. Multiple recent outbreaks have been associated with the reuse of SDVs and misuse of MDVs. Patients have suffered significant harms, including death, as a result of these incidents. The CDC, through its One and Only campaign,⁴ urges health care providers to recognize the differences between SDVs and MDVs. It is not uncommon for health care workers to have difficulty distinguishing an SDV from an MDV (see TABLE 2). All staff handling these medications should be educated on proper hand hygiene, identification of SDVs and MDVs, appropriate use of syringes/needles and bags/sets, and the rules for single-use products.

Organizations must assess the practices occurring at their facilities to identify improper use of SDVs. Areas that should be assessed include nursing units (review practices at refrigerators and patient bedside) and clinics, particularly pain clinics. Questions to ask include: What is being made? Who is making it? How is it used? Review the practices in areas where expensive medications are used, particularly plastic surgery, urology, and neurology. In addition, assess the pharmacy. Questions should include: Is medication in SDVs being saved because of shortages or to control costs? Is staff identifying medications that are SDVs and dating them differently than MDVs? Are reconstitution bags dated as SDVs (limit should be 6 hours)? What TPN ingredients are used?

In addition, consider injectable chemotherapy products, which often are packaged in preservative-free forms. Because of the lack of preservatives, they should be considered single-use vials, and USP <797> guidelines should be followed for using these vials. In their PIs, many manufacturers provide stability information for these formulations once reconstituted, but this information does not address sterility limits and stability information may mislead users to utilize these products for days or weeks.

SEA 54: Safe Use of Health Information Technology.⁵ This SEA builds on SEA 42, published in 2008, which discusses safely implementing health information and converging technologies. Incorrect or miscommunicated information entered into health IT systems can result in adverse events, and interfaces built into the technology can contribute to such events. However, well-designed and appropriately used EHRs, together with robust practices, can reduce adverse events.

An analysis of sentinel events received by the Joint Commission, gathered between January 2010 and June 2013, identified 120 sentinel events that were health IT-related. Factors that may lead to such events were placed into categories. The top three issues were identified:

1. Human-computer interface (33%)—Ergonomics and usability issues resulting in data-related errors
2. Workflow and communication (24%)—Issues relating to health IT support, communication, and teamwork
3. Clinical content (23%)—Design or data issues relating to clinical content or decision support

As facilities become increasingly automated, the potential for IT-related harm likely will increase unless risk-reduction strategies are implemented. The Joint Commission suggests three strategies to avert this risk: development of a safety culture, continual process improvement, and increased leadership (see SEA 54 for more information about these strategies).⁵

PP&P: What issues regarding oversight of radiopharmaceuticals should pharmacy be aware of?
Mansur: It is not uncommon for pharmacists to have little knowledge or experience with drugs used in the nuclear pharmacy. However, the pharmacy director is responsible for oversight of all medications used within the organization, including radiopharmaceuticals and other medications used in hot labs. To improve pharmacy oversight of this area, pharmacists should ask several questions:

• What activities are performed by technologists/others in hot labs? What types of products are made or purchased?
• What medications are obtained from outside nuclear pharmacy vendors?
• How are radiopharmaceuticals and non-radiopharmaceuticals stored, secured, prepared, dispensed, and administered?
• When is a medication order required?
• Is the nuclear pharmacy USP <797>-compliant (ie, aseptic training, hand hygiene, hood certification, labeling, competency training)?
• Is food stored in the hot lab?
• Is there a formulary for radiopharmaceuticals?

In addition, pharmacy should inspect these areas at the same frequency as they do other areas where medications are stored. These inspections should include the same elements as other medication storage area inspections: proper storage of medications, no expired medication products, monitoring of refrigerators, certification of laminar flow hoods, etc. It should be noted that if radiopharmaceuticals are purchased from an outside vendor, the contract must define performance measures and comply with other aspects of LD.04.03.09, the standard in the leadership chapter that specifies requirements for contracted services. Moreover, MM.03.01.01 EP 24, effective July 2, 2014, states that hospitals that use Joint Commission accreditation for deemed status purposes maintain records of the receipt and disposal of radiopharmaceuticals.

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.

References

1. The Joint Commission Web site. Sentinel Event. http://www.jointcommission.org/sentinel_event.aspx. Accessed August 14, 2015.
2. Joint Commission Resources Web site. The Joint Commission Perspectives. http://www.jcrinc.com/the-joint-commission-perspectives/. Accessed August 14, 2015.
3. The Joint Commission. Sentinel Event Alert (Issue 52, June 16, 2014). Preventing Infection from the Misuse of Vials. http://www.jointcommission.org/assets/1/6/SEA_52.pdf. Accessed August 19, 2015.
4. Centers for Disease Control and Prevention and the Safe Injection Practices Coalition. One and Only Campaign. http://www.oneandonlycampaign.org/single-dose-multi-dose-vial-infographic. Accessed August 17, 2015.
5. The Joint Commission. Sentinel Event Alert (Issue 54, March 31, 2015). Safe Use of Health Information Technology. http://www.jointcommission.org/assets/1/18/SEA_54.pdf. Accessed August 19, 2015.