Top Joint Commission Compliance Challenges

November 2014 - Vol. 11 No. 11 - Page #4


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.)

  • MM.03.01.01 Storage and Security of Medications. Given the number of elements of performance (EPs) that are contained within this standard, perhaps it should come as no surprise that facilities are frequently cited for being noncompliant with MM.03.01.01. The standard covers a range of issues from ensuring medication security to monitoring how medications are stored, including verifying refrigeration units remain in range. Although temperature monitoring may be performed manually, the challenge lies in ensuring monitoring is occurring continuously on off-hours and weekends. Surveyors have found that some organizations without automated temperature monitoring systems do not have a mechanism in place for recording refrigerator temperatures at night or on weekends. Although surveyors largely have abandoned the practice of scoring hospitals noncompliant when they miss the occasional temperature reading, a system must be in place to monitor refrigerator temperatures even when the pharmacy is closed. Surveyors are most concerned when they identify a trend in failure to document temperature readings. 

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? 

  • MM.04.01.01 Medication Orders. The Medication Orders standard specifies that organizations have written P&Ps in place that not only identify the specific types of medication orders deemed acceptable for use, but that define the required elements for each order type. Acceptable orders may include PRN orders; standing orders; automatic stop orders; titrating, taper, and range orders; orders for compounded drugs or drug mixtures not commercially available; orders for medication-related devices (eg, nebulizers, catheters); orders for investigational medications; orders for herbal products; and orders for medications at discharge or transfer. Surveyors are finding that most hospitals do have these P&Ps in place; the reason that organizations often are found to be noncompliant is that their practices are not consistent with their policies. 
  • MM.05.01.01 Medication Order Review. Pharmacist review of the medication order prior to drug administration is a critical safety net that the Joint Commission requires, with a few exceptions. Pharmacist review is not required when the medication is needed urgently and there is insufficient time for review or when a licensed independent practitioner (LIP) remains at the bedside during administration of the medication. There also are two area-specific exemptions for pharmacist review of medication orders: in the emergency department, where LIPs are not required to be at the bedside during medication administration, but must be in the area to be able to respond immediately should the patient experience an adverse drug reaction; and in radiology, during the administration of contrast medications, which are protocol-directed. Surveyors will look carefully at any events where pharmacist review was bypassed to determine whether it occurred in compliance with the above stated exceptions. 

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. 

  • NPSG.03.04.01 Labeling in Perioperative/Procedural Settings. This NPSG specifies that all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings be labeled. Labeling should be standardized throughout the organization and must occur when a medication is removed from a labeled package and transferred to another container. In addition, the standard specifies that the following information be included on the label: medication name, strength, amount (if not apparent from the container), expiration date/time, and date prepared. The same standard applies to compounded IVs, but diluent and volume (if not apparent from the container) also must be included. Verify all medication and solution labels both verbally and visually; labels should be verified by two individuals qualified to participate in the procedure whenever the person preparing the medication is not the person who will be administering it. Any medication found that is unlabeled must be discarded immediately. Additional compliance issues in procedural areas include failure to label medications or liquids, insufficient information on the label, and pre-labeling (labeling must occur immediately before or after filling the container). (See NPSG.03.04.01 to view all eight EPs.) 

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.  

  • Clinical Alarm Management. In today’s technology-driven health care environment, patients are connected to multiple alarms or alarm-based devices. NPSG.06.01.01, introduced in 2014 and which focuses on safe clinical alarm management, states that organizations should make improvements to ensure that staff members respond to alarms on medical equipment promptly. Consider that a typical patient in a critical care unit may be connected to 150 to 400 alarms each day. However, alarm-based devices are not standardized in many organizations, and flexible setting features on these devices permit inconsistent use. 

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. 

  • Management of Sample Medications. Management of sample medications has been an area of interest for the Joint Commission this year. In response to concerns voiced regarding compliance when using sample medications, the Joint Commission conducted a comprehensive review of medication management EPs to determine which are applicable to these drugs (see TABLE 2). Each of these EPs has been clarified with the following: Note: This element of performance is also applicable to sample medications. 

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:

  • What medications are allowed?
  • Who provides oversight?
  • Which areas and which patients may receive these medications?
  • What storage and security standards exist for the samples?
  • What record keeping is required?
  • What are the labeling requirements?
  • What patient education should occur?
  • What processes must be established for inspection of storage, drug recalls, and expired drug removal?
  • Appropriate Use of Single-dose/Single-use Vials. Another important issue of concern is ensuring the safe use of single-dose/single-use (SD/SU) vials. According to the CDC, at least 19 blood-borne or bacterial infection outbreaks have been associated with the misuse of SD/SU vials since 2007.1,2 On June 16, 2014, the Joint Commission published a Sentinel Event Alert focusing primarily on the proper use of SD/SU vials to prevent the spread of infection (in addition, a free Joint Commission Webinar is available at The alert recommends that organizations develop and implement effective evidence-based P&Ps for the prevention of misuse of vials (see the alert for a comprehensive list of information to include in P&Ps). It is key that all staff administering injectable medication be trained to recognize when a dosage form is single-use. SD/SU vials should be used only for a single patient during the course of a single procedure. Then the vial must be discarded, as medications in SD/SU vials lack antimicrobial preservatives and are at greater risk for contamination when used inappropriately. 

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


  1. The Joint Commission. Preventing infection from the misuse of vials. Sentinel Event Alert. Issue 52. June 16, 2014. Accessed September 17, 2014.
  2. Centers for Disease Control and Prevention: CDC’s Position—Protect patients against preventable harm from improper use of single-dose/single-use vials. May 2, 2012. Accessed September 23, 2014.
  3. Kirschling TE, ed. The Handbook on Storing & Securing Medications. 2nd ed. Oakbrook Terrace, IL: Joint Commission Resources; 2009.
  4. The Joint Commission. Standards BoosterPak for MM.03.01.01. Accessed September 24, 2014.
  5. The Joint Commission Perspectives. The Official Newsletter of The Joint Commission. Accessed September 17, 2014.

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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