Q & A with Patricia Kienle,
RPh, MPA, FASHP
Pharmacy Purchasing & Products: We generally think of The Joint Commission (TJC) as the organization that surveys hospitals. How are other organizations involved?
Patricia Kienle: CMS has deemed three organizations to provide accrediting services to health care: The Joint Commission, The American Osteopathic Association (AOA), and Det Norske Veritas (DNV). While most hospitals are familiar with TJC, the AOA has also been an accreditor for years and if your facility has an osteopathic medical residency, AOA is accrediting it. DNV was established in Norway in 1864 and has been accrediting hospitals in the United States for two years.
PP&P: Are there similarities amongst the three accrediting bodies?
Kienle: Yes, because each of these accrediting organizations (AOs) has to meet the CMS hospital conditions of participation, their standards contain much of the same language. The differences become apparent in how each organization applies the standards. The Joint Commission, for example, involves practitioners in standards development via public comment and practitioner panels. Every public comment received by TJC is assessed, and an interdisciplinary group of practitioners comprise the Professional and Technical Advisory Committees (PTACs). An ASHP member sits on each of the medication-related PTACs, ensuring pharmacy has a voice in standards. To date, the other two organizations have not used public comment or practitioner panels to develop their standards and interpretive guidelines.
Another commonality between the organizations is seen in the patient safety verbiage. The National Patient Safety Goals (NPSGs) from TJC have been significant drivers of patient safety progress for the last 10 years, and much of the wording from the NPSGs are embedded in the AOA and DNV standards as well as the CMS Interpretive Guidelines.
PP&P: How do the approaches to quality differ between these organizations?
Kienle: Each organization addresses quality measurement in a distinct manner; however, it is up to the facility to determine how they will achieve the quality goals. With TJC, quality standards are embedded in each of the different chapters and end points are defined. The AOA’s Healthcare Facilities Accreditation Program (HFAP) also has quality issues embedded throughout the program, but their main quality impetus is the National Quality Forum’s (NQF)-endorsed 34 safe practices, a number of which are medication related. Many of the NQF-endorsed 34 safe practices originated from the NPSGs, so there is a thread of continuity between TJC’s and AOA’s goals. However, by providing a specific document listing the set of 34 safe practices, AOA creates more of a checklist approach to ensuring quality.
DNV, on the other hand, bases their quality standards on ISO-9001 quality management systems. Using quality standards that were originally developed for the manufacturing industry, DNV adapts them to health care. Some of the ISO-9001 concepts gaining traction in health care include lean processes, best practices development, interdepartmental audits, checklists, and the application of metrics to standards. Currently there are only a handful of hospitals that are ISO-compliant, and many of these are in the Detroit area, reflecting the automotive industry’s commitment to the ISO standard.
PP&P: For facilities that are looking to enhance their existing quality programs, do AOA and DNV provide a structure to do this?
Kienle: Most hospitals—whether accredited by TJC, AOA, or DNV—seek to improve quality. This also holds true for those hospitals that choose not to seek accreditation, and rather are surveyed by their state, using the CMS conditions of participation. For those hospitals, the principles used by the AOs can be used to augment the hospital’s approach to quality improvement. The NQF-endorsed 34 safe practices are a great starting point. Another valuable resource is the ASHP Quality Improvement Initiative (QII) site, which provides support for applying the ISO-quality standards and the 34 safe practices to pharmacy practice. Given the similarities between these programs, quality initiatives based on AOA or DNV standards should not be in conflict with TJC expectations.
PP&P: What are some of the practical differences between these three accrediting organizations?
Kienle: There are two areas that are remarkably different between the approach taken by TJC versus that of AOA and DNV, based on the fact that while all three organizations use the CMS hospital conditions of participation as their core, TJC expands beyond this. For example, TJC prohibits after-hours entry into the pharmacy, although CMS does not. TJC developed this prohibition based on data from the Institute for Safe Medication Practices (ISMP) and others, who demonstrated the risks behind this practice. However, because the practice of nursing supervisors entering the pharmacy after it is closed is not prohibited in the CMS conditions of participation, AOA and DNV do not have the same prohibition. So TJC is certainly comfortable expanding their standards beyond the CMS conditions of participation, while to date, the other two organizations have taken a more static approach. Keep in mind that while CMS can change their interpretive guidelines, changing the conditions of participation literally requires an act of Congress.
The second distinction is also predicated on the CMS conditions of participation. TJC allows exceptions to pharmacist review of medication orders in the event of an emergency and when the process is under the control of a licensed independent practitioner. Because the CMS conditions for participation only provide for an emergency exemption, the AOA and DNV standards, likewise, only provide this exception. For pharmacists overseeing procedural areas in the hospital, for example, this is an important difference.
PP&P: When is a hospital likely to be directly inspected by CMS?
Kienle: CMS can come into a hospital for a number of reasons. Because each AO is audited by CMS, approximately 5% of hospitals recently inspected by their accreditor will have an unannounced, follow-up visit from CMS as part of a validation survey. To validate the accreditor’s operations, CMS will review the application of all of their standards in the hospital. CMS generally contracts this oversight to the state, but occasionally they conduct their own surveys as well. Of course, the annual, or in some cases biennial, state inspections will also survey for compliance to the CMS hospital conditions of participation. Additional grounds for a CMS inspection can include a patient complaint, changes in service, or even an unfavorable news report. Therefore, it is important to take a continuous compliance approach to the accreditation process.
PP&P: How do the inspection methods differ between the three accrediting organizations?
Kienle: Because of the specificity of the standards from AOA and DNV, their inspection process is very direct. For example, they may require that you show your policy for vaccine storage and demonstrate that your thermometer has been calibrated. TJC uses the tracer method, on the other hand, wherein the same questions may be answered but via a more collaborative process. Nonetheless, all of the organizations will cover the same basic issues during an inspection.
PP&P: What are the pharmacy director’s responsibilities in regards to accrediting organizations?
Kienle: To start, you need to know who is surveying your organization. In addition to the hospital accrediting organization, there may be other services in the hospital that are surveyed individually. For example, the long-term care facility, hospice, rehab, and dialysis may all be surveyed by separate groups. The director of pharmacy needs to sit down with the quality department to identify what organizations are surveying the hospital, determine which of those have medication management related standards, and then develop a plan for compliance.
Keep in mind that a single accrediting organization may have a number of survey processes, each with different medication management requirements. TJC, for example, has different surveys for home care, ambulatory surgery, and behavioral health. And while the medication management standards for these surveys are built on the same principles, there are important nuances between them, depending on the population being served.
As the director of pharmacy, you are responsible for medication control in your organization and this includes ensuring compliance with the medication management piece for any organization surveying your hospital. This is true even if the department’s drugs are not provided by your pharmacy, as occasionally happens in hospice, long-term care, or in ambulatory clinics, for example, where an external pharmacy may be contracted to supply the medication. A good way to provide this oversight is to incorporate compliance inspections into the monthly medication area inspections. To successfully demonstrate medication control, the pharmacy director needs to be familiar with all of the accrediting bodies that are surveying the hospital and understand the similarities and differences between the multiple standards that relate to medication management.
Patricia C. Kienle, RPh, MPA, FASHP, an employee of Cardinal Health since 1999, currently serves as the director of accreditation and medication safety. She is the recipient of an MPA in health service administration from Marywood College in Scranton, Pennsylvania, a BSc in pharmacy from Philadelphia College of Pharmacy and Science, and has completed an executive fellowship in patient safety from Virginia Commonwealth University. Kienle is also an adjunct associate professor at Wilkes University in Wilkes-Barre, Pennsylvania.
Assuring Continuous Compliance with Joint Commission
Standards: A Pharmacy Guide, 8th edition
by John Uselton, RPh; Patricia Kienle, RPh, MBA, FASHP;
and Lee Murdaugh, RPh, PhD
National Quality Forum-endorsed 34 safe practices
ASHP Quality Improvement Initiative (QII)
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