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Regulatory Agencies and Accreditation Organizations
December 2011 - Vol. 8 No. 12 - Page #20
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Q&A with Patricia Kienle, RPh, MPA, FASHP
Director, Accreditation and Medication Safety Quality Services
Cardinal Health Pharmacy Solutions


Pharmacy Purchasing & Products: From the hospital pharmacy perspective, how do regulatory agencies affect practice?
Patricia Kienle: First, it is important to recognize the difference between regulatory agencies and accreditation organizations, because their respective impacts on pharmacy practice differ significantly. From the pharmacy perspective, the two most commonly referenced regulatory bodies are the Centers for Medicaid and Medicare Services (CMS), a federal agency; and the state agencies, which refer to either the State Department of Health, which inspects hospitals overall, or the State Board of Pharmacy, which inspects pharmacies specifically.

There are additional agencies that occasionally inspect hospital pharmacies, such as the Occupational Safety and Health Administration (OSHA) and the Food and Drug Administration (FDA), but such incidences are less common. OSHA may inspect a work site following a direct patient or employee complaint or a report of unsafe working conditions. Once in the hospital, it is not unusual for OSHA inspectors to review working conditions beyond those reported; thus, a complaint related to a practice on a unit could result in the pharmacy being inspected by OSHA. The FDA has oversight over, and the authority to come into, a hospital pharmacy, but because this is not their main purpose they usually defer to the state board of pharmacy when it comes to regulatory issues. That being said, there are some situations where the FDA will inspect a hospital pharmacy, particularly if there is a question as to whether the pharmacy is encroaching on practices considered to be equivalent to drug manufacturing. For example, if a hospital is compounding sterile preparations beyond its scope of need and producing unique drug products on par with what a manufacturer might produce, the FDA would be concerned and may inspect the pharmacy, but such events are rare.

PP&P: Given this background, which regulatory agencies are pharmacies most likely to encounter?
Kienle: Certainly the most prevalent regulatory agencies to hospital pharmacy practice are the respective state departments of health and the state boards of pharmacy, as well as CMS. Usually if CMS comes in to review a hospital, there is some pharmacy involvement.

It is worth noting that in cases of diversion or suspected diversion, the regulatory reaction could be on the federal or state level, or both. The US Drug Enforcement Administration (DEA) has a designated Office of Diversion Control that handles many such issues (see http://www.deadiversion.usdoj.gov/ ).

PP&P: What accreditation organizations should a hospital pharmacy be aware of, and how are these distinguished from regulatory agencies?
Kienle: There are three hospital accreditation organizations in the US—The Joint Commission; DNV (Det Norske Veritas) and their program, NIAHO (National Integrated Accreditation of Healthcare Organizations); and the American Osteopathic Association (AOA) and their program, HFAP (Healthcare Facilities Accreditation Program).

While regulatory agencies are very different from accreditation organizations, they do have a common source for all their regulations or standards: the CMS Hospital Conditions of Participation (CoPs). A regulatory agency, such as a state department of health, uses these CoPs to develop their state regulations. Likewise, the accreditation organizations also use them to develop their own standards. The primary difference here is that when a regulatory agency comes in for an inspection, they focus on exactly what is in their regulations, whereas the accreditation organizations have a higher level of expectation. Their standards include all of the basic requirements, but for medication management use, for example, accreditation organizations have more information and more requirements in their standards than the law mandates.

PP&P: What is the primary driver for a hospital to be accredited by one of these organizations?
Kienle: In order to receive federal money, a facility has to be certified by CMS. However, the three accreditation organizations have what is called “deemed status,” which means that CMS has evaluated their standards and practices and deemed them equivalent to the CMS standards. Hospitals may choose to become accredited for many different reasons, but a primary reason may be that by doing so, those facilities will have their given accreditation organization survey them as opposed to having the state come in for an inspection. Keep in mind, such deferments depend on the state; some states will come in and perform checks regardless of accreditation, and some will accept TJC’s accreditation, for example, as evidence of compliance with state regulations.

Further to this, some facilities believe that becoming accredited will result in less scrutiny, but in reality, accreditation organizations, due to their higher level of expectation, tend to inspect more closely than regulatory agencies do. The most important aspect of this comparison is that an accreditation organization cannot shut you down, whereas state or federal agencies can.

PP&P: How does CMS ensure that accreditation organizations are properly following their guidelines?
Kienle: CMS does send their own representatives into hospitals to perform inspections, and while this would usually be done because of a patient complaint, accreditation organizations do need to be checked, so CMS will come in and perform what is called a validation survey. Approximately 5% of hospitals nationwide that have had an accreditation survey will have CMS come in to audit that survey and make sure all CMS requirements are embedded in the accreditation organization’s standards.

Keep in mind that a CMS validation survey will usually be performed shortly after an accreditation survey, so just when the staff has exhaled, CMS can come walking through the door. Again, there is a variety of reasons why CMS would come in and inspect a facility, but a patient complaint or validation survey are the main reasons and as a regulatory body, CMS or the state can levy sanctions or fines, or can even shut down the hospital. Obviously such actions would be the result of an egregious situation.

PP&P: From the pharmacy perspective, what areas are accreditation organizations likely to look into during a survey?
Kienle: All three organizations have very specific overall standards, including a series of medication management standards. They are not always called that, however; DNV and TJC call them medication management standards, but the AOA calls them pharmaceutical standards. I tend to prefer the term medication management standards, because it demonstrates applicability not only to the pharmacy, but also to any place a medication is stored or used within the organization. In the past, TJC had a pharmacy services standard as well, but it expanded beyond the pharmacy and subsequently indicated that the director of pharmacy is responsible for all medications under an organization’s umbrella. TJC, for example, does define what is meant by the term medication, so being aware of this can be beneficial to compliance.

PP&P: Are regulatory agencies looking at the same areas?
Kienle: In the CMS CoPs, there is a pharmaceutical services standard, but what is particularly interesting is that there are medication-related guidelines in the CoPs outside of that pharmaceutical services standard. There are some listed under nursing services, medical staff, performance improvement, and various radiology services, so if a pharmacy director is unaware of this and only looks at the pharmaceutical services standards, he or she would miss some medication-related guidelines in those other areas. The accreditation organizations have generally consolidated these outside standards under their own medication management standards, but not all are covered.

PP&P: How rigid are the CMS conditions of participation?
Kienle: The CMS CoPs are literally an act of Congress; therefore, a federal process is in place to enable changes. In fact, just recently a section of the CoPs was published in the federal register for comment, and while it is not directly medication-related, it does involve infection control, which often overlaps medication management. Thus, in order to change the CoPs, a proposal has to be published in the federal register, there has to be a public comment period, and those comments have to be vetted. The result is a long, arduous process to enact change. Conversely, TJC, for example, has a practitioner group that constantly reviews CMS standards and makes appropriate, contemporary changes to their own standards without having to go through such an arduous process.

There is another set of federal standards that are easier to change—the Interpretive Guidelines of the CMS Hospital Conditions of Participation. For several years, ISMP, ASHP, and others have demonstrated the need to change the interpretation that medications must be given within 30 minutes of their scheduled time to one where the hospital must define for itself appropriate timeframes for specific medications as needed. Within the Interpretive Guidelines, the language describes time-critical scheduled medications in terms of classes such as antibiotics, anticoagulants, insulin, and anticonvulsants. Hospitals are allowed to define specific parameters for certain products, but I do not see that they have to list such parameters for every single drug. Of course this remains untested, so we do not know yet how it is going to play out in a real world setting.

Accreditation organizations also incorporate best practices that have developed over the years as healthcare practices—particularly medication management—have changed. As long as the core of CMS CoPs remain, then the standards can evolve along with pharmacy practice. It is important to remember that facilities must meet any applicable federal and state laws or regulations, even if they fall outside of what CMS or any of the accreditation organizations entail. For example, state board of pharmacy regulations have additional laws that are not part of CMS or any of the accreditation organizations, but facilities have to comply with those as well. So for accreditation organizations, part of the expectation is that not only do you meet their standards, but you also meet any applicable federal or state laws or regulations.

PP&P: In light of this, how can hospital pharmacies avoid problem areas or prepare for them accordingly?
Kienle: There are four basic elements that all pharmacy directors should be aware of: the CMS conditions of participation, the standards of their accreditation organization (assuming the facility is accredited), their state’s department of health requirements for medication management, and their state’s board of pharmacy regulations. While many of these elements overlap, there are likely certain specifications found in one place and not the other.

When looking at CMS alone, every pharmacy director should be able to access the CoPs, as well as CMS interpretive guidelines, which are surveyable, and CMS surveyor guidance, which technically are not surveyable, but do guide the surveyors on what to look for. All of these elements are very transparent and every hospital should have a copy of these.

PP&P: As we approach the end of 2011, are there specific accreditation issues looming in 2012?
Kienle: Storage of medications remained an issue for more than a third of hospitals this year. Furthermore, facilities can expect increased emphasis on areas outside of hospital walls, yet still within the purview of the healthcare organizations. As such, directors of pharmacy need to have a discussion with their legal or risk management departments as to which areas are truly part of the hospital’s application for survey.  Often the director is well aware of medication use in the nursing units, but may not be taking into account physician practices, outside clinics, or ambulatory areas that are physically outside the walls of the hospital, but nevertheless remain under the auspice of the pharmacy. The pharmacy director is still responsible for ensuring that all applicable medication management standards are met at those areas as well.

Another area that is expected to see increased emphasis involves the aforementioned infection control issues. The CDC largely is driving this recently published federal register change. It is a checklist of questions that state and CMS surveyors would use when inspecting hospitals; for example, there are elements embedded in those questions covering appropriate use of single-dose vials, multi-dose vials, and IV sets. These are areas that practitioners may think are peripheral to pharmacy, but often overlap pharmacy requirements. (To view the Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care, visit http://www.cdc.gov/HAI/settings/outpatient/checklist/outpatient-care-checklist.html/ )


Patricia Kienle received her MPA in health service administration from Marywood College in Scranton, Pennsylvania, a BS in pharmacy from Philadelphia College of pharmacy and Science, and has completed an executive fellowship in patient safety from Virginia Commonwealth University.

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