By Kurt A. Patton, MS, RPh

The best way to prepare the pharmacy for a Joint Commission survey is to perform a rigorous self-assessment, either prior to the due date of your Periodic Performance Review (PPR) submission to the Joint Commission (TJC) or prior to your annual evaluation of the medication management process as required in MM.08.08.01. This assessment must follow the complete medication management process and not be confined just to the pharmacy. While the medication management process is certainly interdisciplinary, the Joint Commission looks to pharmacy to provide leadership in these processes. The selfassessment should follow the medication management standards, paying particular attention to the new language and formatting of the standards for 2009. 

Patient Specific Information: MM.01.01.01
The introduction to this chapter includes an outline, which the standards follow. However, it is important to note that the first part of the process — having accessible patient specific information — is not identified in the outline. A key point to consider in your self-assessment is how this information is supplied and updated. Is it static upon admission, or is it constantly updated from other information systems at the hospital? Review your current process for obtaining the following ten bulleted pieces of information required by this standard: 

• Age    

• Sex

• Diagnoses
  

• Allergies
  

• Sensitivities
  

• Current medications
  

• Height and weight (when necessary)
  

• Pregnancy and lactation information (when necessary)
  

• Laboratory results (when necessary)
  

• Any additional information required by the organization 

Since this is an A element of performance you must be successful inobtaining all ten, there is no partial credit for obtaining nine of thebulleted requirements. One issue that hospital pharmacies often struggle with is obtaining information about pregnancy and lactation status. You want to avoid telling the surveyor that you do not have a system in place to do this. Access to a hospital-wide medical record system containing the information is sufficient as long as staff can articulate that they would access this system prior to dispensing teratogenic medications, or medications known to be excreted in breast milk, to a woman of child-bearing age.

High-alert and Hazardous Medications: MM.01.01.03
MM.01.01.03 establishes requirements for high-alert medications. The key point to remember here is that high-alert medications are not synonymous with look-alike/sound-alike medications. Many medications may be on both lists, but high alert medications are those known to be especially toxic, for which you institute additional safeguards. It is up to you to design the safeguards in the policy, but once established, the surveyors expect to see the policy uniformly instituted throughout the organization. For example, if your policy states that telephone orders for high-alert medications are not permitted, or supplemental labeling is required, or orders must be printed in block letters, then you have to demonstrate that these processes are followed organization-wide. Therefore, avoid writing a policy that reads well, but is difficult to implement. Rather, your policy should read well and be practical enough to implement easily.

Selection and Procurement: 02.01.01
This section has not had the most frequently scored standards, and the update for 2009 is essentially a regrouping and rewording rather than new requirements. One requirement to note is the process for adding new medications to the formulary as the rewritten format is much clearer. EP 2, another A or absolute performance expectation, outlines eight issues to consider before placing a new drug on formulary. These issues are:

• Indications for use    
  
• Effectiveness
  
• Drug interactions
• Potential for errors or abuse
• Adverse drug events
• Sentinel event advisories
• Other risks

Cost
This additional clarity may also be noted by surveyors in 2009, so make sure that your formulary evaluation process includes all eight factors. Given that this is an A element of performance, consideration of only seven factors will lead to an RFI.

Storage: MM.03.01.01
This standard has been the most frequently scored standard in the entire hospital accreditation manual for several years. The chief problems have been improper medication storage in refrigerators or warmers and inadequate control of expired medications. As A elements of performance, these required absolute adherence in implementation. The good news for 2009 is that both of these issues now fall under the C category elements of performance, meaning only 90% compliance is required to achieve compliance with the standard. There is one potential pitfall in this change, however. Should one location in the hospital receive all of a surveyor’s noncompliant observations, the hospital may still receive an RFI even if the overall compliance rate is 90%. In other words, if medication temperature is never documented in pediatrics, for example, even with an overall compliance rate of 90%, you may still receive an RFI. So while the requirements have eased somewhat for 2009, there is still the potential for problems.

Another concept under this standard that is sometimes overlooked is the requirement to create a policy for storage of medication upon receipt by a health care provider, but prior to the actual administration to the patient. This element of performance is confusing to many.

Essentially, it requires a policy be established for medications that a respiratory therapist or anesthesiologist may take, for example, such as multiple doses to treat an entire unit, or an entire shift of patients. The policy must describe how these medications will be safely stored, secured, and protected from excessive heat or humidity until used. Again, once you develop the policy, there is also a corresponding implementation element of performance, so you need to ensure the policy is carefully adhered to.

Storage: MM.03.01.05
Previously in this standard, an element of performance asked the hospital to develop procedures for patients’ own medications and a second EP asked the hospital to establish a policy as to what, if anything, would happen with medications that a physician wanted to bring into the hospital. In 2009 these concepts have been folded together into one requirement. Too often, hospitals do not develop a policy regarding procedures for physicians who want to bring a medication into the hospital that was obtained or compounded elsewhere. This issue must be addressed, and if you choose to allow these products in your institution, processes must be established to verify product integrity.

Ordering: MM.04.01.01
Pharmacists will be familiar with this standard from its previous reference number MM.3.20. This standard requires the hospital to establish policies to ensure the following:

• Range orders are uniformly understood and administered
• PRN orders include an indication for use
• Blanket reinstatement orders are prevented

These concepts are still grouped together for 2009, and the challenge remains in making sure the right processes are followed. When range orders are used, the staff must to be able to articulate when they would give the high dose, when they would give the lower dose, when they would give the IM, when they would use a four-hour interval, etc. The problem many hospitals face is that when asked, ten employees often give ten different interpretations. Thus, the solution is getting all the details into the order itself. This can often be accomplished by greater use of preprinted order sets, which allow the clinician to detail all the conditions for use, such as severe pain, mild nausea, fever, etc. With preprinted order sets there are several very important issues to consider. There must be a formal review and approval process that includes a screen to prevent the use of any unapproved abbreviations. One unapproved abbreviation on a preprinted order set will lead to an RFI and there is no opportunity to clarify it. The Joint Commission treats unapproved abbreviations on preprinted orders much more harshly than those on handwritten orders. The theory behind this is that any clinician may make a single error and use an unapproved abbreviation, but given that hospitals are supposed to have review and approval mechanisms for preprinted order sheets, they should never contain an unapproved abbreviation. In addition, an unapproved abbreviation on a preprinted order sheet implies that this abbreviation is repeatedly used inappropriately. Another issue of importance when using preprinted order sets is ensuring that the physician signs the order set, or authorizes its use verbally before instituting the order set. Sometimes we look at these as Dr. X’s “standing orders” for everyone, but there are federal and some state prohibitions against standing orders, or medications administered without a valid physician order. The only medications that CMS authorizes for use in this way are the influenza and pneumococcal vaccines.

Lastly, this standard contains the requirement in EP 9 to make sure that a diagnosis, condition, or indication for use exists for each medication. The element of performance does not require this to be on the order sheet, but somewhere in the chart. Some hospitals choose to exceed the requirement and mandate it on every medication order. If you opt for this policy, remember that the Joint Commission will hold you to it. While the Joint Commission requires that PRN medications either contain indications for use, or otherwise be clearly known to caregivers, there is no similar mandate for scheduled medications. That indication can be elsewhere in the chart.

Preparing and Dispensing: 05.01.01
This standard, previously known as MM.4.10, requires a pharmacist-first dose review program for all newly ordered medications. Hospitals have struggled with this requirement for several years, particularly with medications in the ED. The Joint Commission has now defined the ED as a physician-controlled environment, meaning that patients being treated in the ED can bypass this first dose review requirement. Unfortunately, there are many other sites in our hospitals that are not physician-controlled environments, which remain problematic. You need to identify these settings and if they are not physician controlled, determine whether there is such an urgent need for the new medication that it makes sense to bypass pharmacist-first dose review. One technique to consider in those settings is removing access to medications that cannot reasonably be considered urgent. Instead, these would be obtained from the pharmacy after review.

EP 10 under this standard has a clearly written requirement that may prove difficult in 2009 as it requires the review of new medication orders for “variation from the hospitals approved indications for use” list. Many hospitals do not have such a list, or they defer to the package insert indications for use. To make this additionally difficult, if your institution does not mandate including an indication for use on each medication, it is difficult to know what a medication is being prescribed for. In past years this was not a frequently scored issue, however, this may change with the newly written EP for 2009.

Preparing and Dispensing: MM.05.01.07
This standard in EP 1 requires that pharmacists prepare all sterile admixtures with exceptions for urgent situations or when stability cannot be maintained. EP 2 then states that regardless of where the IVs are made, clean or sterile technique must be used and a clean, uncluttered, and functionally separate area for product preparation must be maintained. Finding such a location on the patient care units is often difficult. During your survey preparations you want to identify these locations and make sure they fulfill the expectation. There are also training considerations covered under the human resources standards to ensure that anyone who prepares IVs has comparable training or competencies. Bear in mind that the Joint Commission does raise the level of expectation for hospitals in states that have incorporated the USP <797> guidelines into their state regulations.

Preparing and Dispensing: MM.05.01.11
EP 5 states that patients be educated about the hospital’s medication dose packaging system. Few hospitals do this today, but if medication education is part of your administration process, you could incorporate the requirement there. Some hospitals are also considering the wide array of educational issues detailed under the expanded NPSG 13, and this provides another place to address this issue. Either way you will need to develop a practical and effective means to do this for 2009.

Preparing and Dispensing: MM.05.01.13
There is nothing new in this requirement for 2009, but small and rural hospitals face a challenge if they do not provide 24/7 pharmacy services. On occasion, night staff will need to access a new medication and the standard makes it clear that this cannot be done by permitting nighttime access to the pharmacy for other hospital staff. A night cabinet must be available, outside of the pharmacy. Even if your state law permits non-pharmacy personnel to access the pharmacy, the stricter rule applies and the Joint Commission does not permit this access in accredited hospitals. There is also a requirement for a pharmacist on-call system to be in place when the pharmacy is closed.

Administration: 06.01.01
Under this standard, there are two clearly written and potentially problematic EPs for 2009. EP 6 states that before administering medication, the administering individual must verify that no contraindications exist. This can be done if you have a pharmacy information system in place and the pharmacists bring potential problems to the attention of the provider. The challenge is figuring out how to alert your nursing staff to those potential problems and/or ascertaining whether the physician was aware of them.
EP 9 states that patients and families are to be informed about potentially significant adverse drug interactions for new medications. This requires defining what a potentially significant drug interaction is and determining how to get that information to patients or families. One solution is to try and reduce the scope of the problem by defining potentially significant adverse drug interactions as all black box warning drugs, or those that already have federally mandated patient package inserts. You can also supplement this with routine education, which may include leaflets for any new drug.

Evaluation: MM.08.01.01
This standard requires that the effectiveness of the medication management system be evaluated and it includes eight elements of performance, each of which is categorized as an A:
    1. Collect data on the performance of the medication management system
    
    2. Analyze the resultant data
        
    3. Compare data over time to identify risk points, levels of performance, patterns, trends, and variation
   
    4. Review the literature and other external sources for new technologies and best practice
   
    5. Identify opportunities for improvement based on data analysis and literature review

    6. Take action on improvement opportunities identified as priorities

    7. Evaluate changes to confirm that they resulted in improvements
   
    8. Take action when planned improvements are either not achieved or not sustained

To address this standard, prepare an annual report with individual sections evaluating each of the eight EPs. The evaluation should include planned actions as well as analysis of the results of those actions. Have the report reviewed and approved by an oversight group, such as the pharmacy and therapeutics committee. The final result should be a clear plan of action, with detailed outcomes.

Conclusion
During the preparation process, it is key to prepare a policy statement to standards crosswalk. In other words, review the Medication Management chapter from TJC’s Comprehensive Accreditation Manual for Hospitals (CAMH), noting next to each element of performance precisely where in your policies you address that EP. While it is easy to review a list of standards and mentally check off those that you feel you are in compliance with, you cannot be completely confident of your full compliance until you identify the specific written policy that outlines your compliance practices for each standard. Review each of these policies to ensure that the wording precisely matches the EP requirement. In addition, for all standards with a performance expectation of 90% (i.e., a C element of performance), be sure you have a measurement plan to verify that you can consistently achieve 90%.

With thorough preparation, you can start your next TJC inspection with confidence that your pharmacy is fully compliant and prepared to demonstrate this compliance.

Now the owner of Patton Healthcare Consulting, LLC, Kurt A. Patton, MS, RPh, served as executive director of accreditation services at the Joint Commission for over seven years, until his retirement in December 2005. Before joining the Joint Commission, Patton was the deputy director for the Division of Strategic Initiatives and Managed Care in the New York State Office of Mental Health. Previously, he served as the administrator for a state-operated behavioral health managed care program and as the director of the Bureau of Health Services. Patton earned his bachelor’s degree in pharmacy and his master’s degree in institutional administration from St. John’s University.