Challenges in Accreditation Compliance

January 2013 - Vol.10 No. 1 - Page #2
Category: Accreditation Survey Consulting

Q&A with Kurt Patton, MS, RPh
Owner, Patton Healthcare Consulting, LLC


Pharmacy Purchasing & Products: What was the most problematic MM standard scored on surveys in 2012 and why?
Kurt Patton: For hospital pharmacy practitioners, the most problematic medication management standard remains MM.03.01.01. This standard can be challenging to comply with due in large part to the numerous elements of performance (EP) and areas of focus associated with it. More specifically, this is the standard that scores issues relative to medication storage, including refrigeration, temperature monitoring, use of warmers, expiration dating of warmed products and multidose vials, medication security, and control of medications after receipt and prior to administration, among others.

Monitoring Refrigerators and Warmers 
Currently, refrigerator and warmer monitoring are two of the most problematic aspects of this standard. The most common practice failure involving refrigerators is the absence of required temperature documentation along with failing to take action when the temperature of a refrigeration unit moves out of the required range. Likewise, with warmed products—usually either IVs or contrast media—a common failure point is maintaining the product at either a higher temperature or longer than what is recommended by the manufacturer. In order to gain some insight into best practices for warming products, request and closely review the policies and procedures (P&Ps) for warming products in your facility’s operating rooms and radiology department, areas likely to have established experience with such procedures.

Medication Security
The issue of properly securing medications remains problematic when actual practices are not as tightly controlled as mandated by your organization’s policy. When establishing a policy on securing medications, it is necessary to pay careful attention to actual practices and compare those to what is permitted by your state’s board of pharmacy regulations. The goal is to avoid writing an excellent policy that does not reflect the actual practices in your hospital. 

Keep in mind that contrast media, IV bags, and irrigating fluids are viewed as medications and must be handled accordingly, unless there is an adjunct policy explicit to those products. Otherwise, they are subject to the same security expectations as your overall medication control policy. 

BUD for Multidose Vials
The failure to properly date and discard multidose vials is frequently scored under standard MM.03.01.01. One of the most common and fundamental errors is failing to assign and physically place an expiration date on the vial. Another common issue is not properly discarding the vial when it reaches its expiration date. Adding to this, CMS has introduced a new twist to this expectation by developing guidance for their surveyors to determine whether multidose vials are being discarded after a single patient use in a procedural setting, as required. While this same expectation does not apply to medication-room use, it does apply to operating rooms and other procedural areas where there is a risk of contamination due to re-entering a vial with a contaminated syringe or needle. 

Establishing Medication Control
Finally, EP 4, which requires the hospital to have a written policy addressing medication control after receipt by the provider and prior to administration, is another common challenge. This is just one of the 19 EPs in this chapter that require a written policy, yet this particular policy is frequently missing. A second problem with EP 4 is that too often the policy does not adequately take into account the actual practices of respiratory therapists or anesthesiologists. If these practitioners are carrying medications on their person and the facility’s policy does not expressly permit this activity, that is a conflict that can be scored.

PP&P: Beyond medication storage, what other standard has posed a problem for pharmacy?
Patton: The second most frequently scored standard in 2012 was MM.04.01.01, under which issues such as unqualified PRN orders or ambiguous range orders are scored. While there has been some improvement in our industry on these points, there are still some organizations that believe their staff can accurately state a complex policy expectation that will somehow make up for the lack of specificity in a PRN or range order. While pharmacists can monitor for this lack of specificity on units that are profiled, it frequently arises as a problem in areas not often profiled, such as the post-anesthesia care unit.

PP&P: What changes should hospital pharmacies expect to see in MM standards and medication-related NPSGs for 2013?
Patton: There are two changes that pharmacists should be aware of for 2013. The first actually started in July of 2012 and involves standard MM.02.01.01, which requires the organization to identify the populations served when approving a new medication onto formulary. Defining the population served can be as simple as designating pediatrics, or adults, or ICU patients only, but it must be defined in some way. It also is important to note that this standard has nine bulleted requirements, each of which must be addressed (see Figure 1).

The second change that should be anticipated for 2013 involves standard MM.04.01.01, which includes a new element of performance—EP 15—that becomes effective as of January 2013. This EP requires the hospital to have a process for periodic review of preprinted electronic standing orders, order sets, and protocols for medication ordering, a process that should include input from pharmacists, physicians, and nurses. The review process also should take into consideration quality assurance monitoring of the accurate use of preprinted order sets and standing orders. One point of confusion on this EP is the definition of a standing order; standing orders are a very limited subset of the orders used in a hospital and involve orders that a nurse may administer after conducting a clinical screening, yet prior to a physician documenting the actual order. Classic examples of a standing order are those for an influenza vaccine or pneumococcal vaccine. Both CMS and TJC recognize that standing orders have value in the patient care setting; however, pharmacy managers should verify that their state regulations also permit standing orders, as a few states still prohibit them.

Of note, there are no new medication-related national patient safety goals (NPSGs) slated for 2013, nor does there appear to be any significant scoring difficulties with NPSGs other than the common issues with conducting proper medication reconciliation or the continuing difficulties with properly labeling medications on the sterile field.

PP&P: In what areas did hospital pharmacy improve in 2012?
Patton: Two areas in which hospital pharmacy has seen significant improvement is ensuring that PRN orders are qualified and driving out ambiguous range orders. Further to these, an additional area of improvement has involved therapeutic duplication where two or more drugs of the same therapeutic purpose are prescribed simultaneously. In such a case, it should be crystal clear when the first agent should be used, when the second agent should be used, and so on.

PP&P: How can hospital pharmacies ensure compliance with TJC regulations when handling hazardous drugs?
Patton: It is particularly important that hospital pharmacies develop a comprehensive understanding of and ensure compliance with their own state’s board of pharmacy regulations. Some states have taken a very proactive stance and TJC surveyors may be familiar with those states’ expectations. Specific to hazardous drugs, there are two similar but slightly different issues to be concerned with, the first being the protection of health care workers from medications which may be hazardous to the user, and the second being protecting the environment from hazardous pharmaceutical waste. Fortunately, hospitals appear to be trending toward providing better protection for workers and employing more comprehensive waste management practices.

PP&P: What resources are available to hospital pharmacy to prepare for a TJC inspection?
Patton: TJC posts frequently asked questions to its website and also has published a detailed booster pack describing all the requirements of MM.03.01.01. This booster pack should be studied carefully in preparation for a TJC survey. Networking with colleagues who have recently been surveyed also can be a wonderful resource, as they can share their experiences, help shed light on what standards were covered, and outline any specific problems they encountered during their survey. Furthermore, keep an eye out for any live educational sessions on regulatory standards in your area that are supported by TJC or your state hospital association. These sessions can prove particularly advantageous. 

PP&P: Why do beyond use dates continue to cause problems for pharmacy?
Patton: When it comes to beyond use dates (BUDs), two issues arise, one cognitive and the other performance-related. Generally, the cognitive issue is a failure to fully realize that TJC expects to see a valid product expiration date clearly indicated on the product, not the date the label was affixed or when the product was opened. Naturally, the performance aspect deals largely with ensuring that any staff members who touch or use these products appropriately assign a proper BUD when working with a multidose vial or placing a product in a warmer.

Moreover, significant benefits can be gained by having the pharmacy provide closer oversight and more frequent monitoring of locations where pharmaceutical warming is taking place. Likewise, assessing the levels of staff compliance with proper expiration dating of multidose vials is also advantageous. If compliance is found to be low, then alternative solutions should be considered, such as assigning an expiration date when the product is dispensed or placed in an automated dispensing cabinet. By doing this, the responsibility for correct expiration dating is placed on a smaller number of staff, as opposed to attempting to ensure possibly hundreds of different staff members on all shifts adhere to the policy.

PP&P: How can pharmacy address medication issues in other departments (ie, ORs, procedural areas, nuclear medicine, outpatient areas, clinics, etc)?
Patton: There are opportunities for improvement when addressing medication issues in areas outside the pharmacy. Begin by making sure that pharmacy staff are actually (and frequently) spending time in these areas inspecting for appropriate storage. Integral to this process is the thoroughness with which the inspection takes place. I suggest using the same or similar techniques utilized by TJC surveyors, which include opening every cabinet and drawer, regardless of whether they are used for medication storage. It is logical that a pharmacist familiar with a location will inspect only appropriate, authorized storage areas, whereas the employees staffed at that location may use an unauthorized area to store expired products. Therefore, any pharmacist sent to inspect an outlying medication storage area should attempt to review it as if they have never been there before. A somewhat amusing mnemonic device for this kind of technique is to consider it a mother-in-law inspection. 

PP&P: What are the most significant challenges with medication ordering and how can these be overcome?
Patton: The biggest problems involve ambiguity with range orders, PRN orders, and therapeutic duplication. Interestingly, the best system by which to avoid these problems already exists, and that is for pharmacy to review new medication orders for compliance with hospital P&Ps. Unfortunately, as a consultant I frequently see situations where hospital pharmacy staff have essentially given up on trying to clarify the glut of ambiguous orders that are submitted. The obvious repercussion is that when surveyors see these orders, it makes for an easily scorable area.

PP&P: What issues need to be addressed with radiopharmaceuticals and nuclear medicine?
Patton: Possibly the most important issue here is that most hospitals contract out the preparation of these isotopes on a prescription basis, yet this may not have been adequately evaluated under the contracting standards. This is not necessarily the responsibility of the hospital pharmacy, but it is a responsibility of the hospital to develop performance expectations for the contractor and to monitor compliance.

PP&P: With medication reconciliation remaining a challenge for many institutions, what expectations does TJC expect facilities to meet?
Patton: There are two major areas of persistent difficulty with medication reconciliation standards. The first involves the analysis of an inpatient’s medication list, which requires the documentation of any decision making (including no action taken) based on that list. If an inpatient reports taking ten different medications at home, there needs to be a documented decision made regarding each of those ten medications. The decision should be fairly simple, restricted to a determination of whether to continue, discontinue, or change the regimen for individual medications. Too often, the home medication list is recorded and medications are prescribed, but one or more medications from the original list go unaddressed. Even if the decision is clear to all involved, it still must be documented.

The second area of difficulty with medication reconciliation involves the process that needs to take place at the time of a patient’s discharge from the inpatient setting. In all such cases, the patient must be given written guidance explaining which of their home medications they should resume taking and which new medications they should begin taking when they go home. This guidance should be in the form of a printed list that is discussed with and given to the patient. Commonly, the guidance provided only focuses on the new medications prescribed in the hospital and ignores previously prescribed medications leaving the patient unsure as to what to do regarding those medications.

Overall, I see hospitals continuing to struggle with decision making about a patient’s existing medication list at the time of admission, as well as providing one comprehensive list of medications at the time of discharge. Strangely enough, these problems do not appear to be leading to an uptick in TJC requirements for improvement. Scoring of this safety goal has been generally minimal; it almost appears as if word has traveled among surveyors not to score this standard. 

PP&P: What medication security issues in the ED should be considered, such as medication access for EMTs?
Patton: Ultimately, it depends on the ED. Some facilities have implemented excellent control systems that rely heavily on ADCs for all types of products, as well as fully integrated CPOE. In others, medication control systems are much looser and still employ increasingly archaic tools and methods, such as medication cupboards and frequent verbal orders. Sometimes these actions are carefully documented and therefore continue to suffice, whereas others are left unmaintained. Pharmacy operations with sophisticated automation often designate a specific ADC just for EMT staff, a practice that works well assuming this access is specified in their P&Ps for medication access. As with many functions in hospital pharmacy, systems and actions involving medication control in the ED (or anywhere else, for that matter) must have coordinated documentation systems that follow internal P&Ps. This is a basic expectation of TJC and other regulatory and accreditation bodies.

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, he was the deputy director for the Division of Strategic Initiatives and Managed Care in the New York State Office of Mental Health. Previously, Kurt served as the administrator for a state-operated behavioral health managed care program and as the director of the Bureau of Health Services. He earned his bachelor’s degree in pharmacy and his master’s degree in institutional administration from St. John’s University.

Oversight for Outsourced Compounding

PP&P: What medication-related areas do you expect surveyors will focus on in 2013 and how can pharmacy prepare? 
Patton: Because of the deadly meningitis outbreak caused by contaminated compounded products, I anticipate TJC surveyors will conduct a more thorough review of how facilities prepare to outsource pharmaceutical compounding. Issues related to the process of gaining supplemental care and services through contractual agreements with outside vendors are evaluated under standard LD.04.03.09; this is particularly relevant to the practice of outsourced compounding, which is an area of clinical contracting that has been growing in dependence and importance for several years. 

Furthermore, all TJC surveyors have a basic understanding of the expectations put forth by USP <797>, but it is likely they will become more proficient as a result of the terrible consequences of this tragedy and others like it. Therefore, in order to best prepare for TJC inspections, hospital pharmacies that contract out the preparation of prescription pharmaceuticals should have performance expectations pre-built into their contracts. These expectations should be developed with input from relevant stakeholders and should include a performance evaluation aspect. This process does not necessarily need to apply to the process of contracting with manufacturers who have been inspected by or are otherwise approved by the FDA as a manufacturer (per documentation), but does apply to independent, specialty compounders of patient-specific prescription drug products.


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