Neelu P. Patil, PharmD, BCPS

Neelu P. Patil, PharmD, BCPS               Rochelle Vargas, BS

Best strategies to help the pharmacy department get ready for a survey and stay ready.

	Regulatory compliance is one of the most important aspects of hospital pharmacy, but it can be underappreciated. The hospital system and pharmacy are surrounded by regulations, and it is essential for all members of the pharmacy team to be familiar with these regulations and medication management standards to ensure compliance with all functions associated with medication use. The purpose of these standards is to ensure safe and consistent care of patients. Here are some of the “must know” points regarding hospital pharmacy accreditation—who is involved, what they are looking for, and how you can be prepared.

	The regulatory compliance of a hospital pharmacy is assessed through accreditation. Accreditation means that you are certified as meeting a standard or certain performance level. Currently, there are 3 hospital accreditation organizations in the United States: The Joint Commission (TJC), the American Osteopathic Association’s Healthcare Facilities Accreditation Program (HFAP), and the DNV Healthcare program National Integrated Accreditation for Healthcare Organizations (NIAHO). These organizations have very specific overall standards. When these organizations survey the institution, you must not only meet their standards but also any applicable federal or state regulations. While the goals of the 3 accreditation organizations are similar, each one is a little bit different. Make sure that you know the standards of the organization that you work with.

	What are the benefits of being an accredited hospital? The accrediting agency provides peer-reviewed standards to help the organization identify performance measures. Also, being an accredited hospital shows that there is a commitment to quality and patient safety. Studies have shown that hospitals that adhere to set procedures are able to provide better patient care than those that do not. Another important benefit is the financial implication. Reimbursement is tied to receipt of federal funds for services provided. In order to receive federal payments, an institution must be certified by the Centers for Medicare & Medicaid Services (CMS). The 3 accreditation organizations have “deemed status” in which their standards are at least equivalent to CMS standards.

	Surveyors provide a rigorous evaluation of the hospital’s processes and helpful expert advice on how to improve them. For the hospital pharmacy setting, they are concerned with how the pharmacy functions to provide the best quality of service for the hospital system. Some of the specific items looked at include practices relating to medication management, departmental policies, quality assurance initiatives, and performance improvement data.

	Knowing frequently scored standards in other organizations can help your institution pay special attention to these topics when undergoing preparation efforts. Start early to work with organizational leaders in addressing these before your accreditation visit. For example, a top Joint Commission medication standard scored as noncompliant in 2011 related to medication storage issues and medication security. In this standard, it is required that hospitals store all medications in a secure area to prevent diversion and be locked when necessary. To comply with this, hospitals should ensure that mobile medication carts are stored in a locked room or are under constant surveillance, medications are not lying on counters accessible to the public, and areas that should be locked remain locked.

	Accreditation surveys are undoubtedly challenging to prepare for and can be a major source of consternation for pharmacy staff. Preparing for a survey is now a continuous process in health care organizations. Preparation for a future survey can be time-consuming and resource intensive, but an organized approach is the best way of being prepared. Here are some strategies you can employ to help the department get ready—and stay ready.

	Efforts should begin well in advance of the upcoming survey. One way to start is to perform an overall self-assessment of how both the department and hospital policies and procedures align with each of the accrediting organization’s standards. A detailed action plan can be developed from this information to help identify gaps, resulting in quality assurance initiatives and audit planning. Having started early, you can have time to correct deficiencies and educate staff. It is also important to stay knowledgeable about the standards, interpretations, and standards changes to ensure continuous compliance. An organization is never really finished—it takes due diligence at all times because expectations are always changing.

	Conduct compliance “readiness rounds” with hospital leadership to all pharmacy areas. The purpose of the rounds is to ensure overall compliance and correct non-compliance issues, as well as provide additional staff education. These rounds will allow staff members the opportunity to ask critical questions and obtain valuable responses from leadership. Rounding frequency should increase as the date of the survey approaches. Also, there has been increased interest by accrediting organizations on areas outside of the pharmacy department which are utilizing and preparing medications, such as outpatient ambulatory areas or physician practices. These areas should also be part of the unannounced rounds to ensure compliance with medication standards since the pharmacy department is ultimately responsible for medication use in the organization. Also, educational handouts can be very helpful to increase staff awareness. This could be through the creation of pocket guide resource books on accreditation standards and pharmacy procedures, posting of Joint Commission National Patient Safety Goal fliers throughout the department, departmental policy review and updates, attendance at staff meetings for question and answer sessions, creation of checklists to assist staff in preparing their area for survey, and frequent departmental newsletter updates.

	A variety of approaches should be used for staff education. One example we used at our institution was to place red balloons near fire extinguishers and pull stations to highlight fire safety, as well as perform fire drills. This was well received by staff and it made employees remember what to do in the event of a fire emergency.

	There is a way to prepare so the survey journey becomes a familiar path. The best preparation is to follow your hospital’s policies in everyday work, because they should be based on practices that promote quality of care and patient safety, and meet regulatory standards. Continuous readiness should become a part of departmental culture, and embedding standard compliance into daily operations is the key to a successful survey. With thorough preparation, you can start your next accreditation survey with confidence and be prepared to demonstrate compliance.

Neelu P. Patil, PharmD, BCPS, currently serves as the compliance and policy specialist for the UNC Health Care Pharmacy Department. She earned her bachelor’s from the University of Tennessee in Knoxville and doctor of pharmacy degree from the University of Tennessee Health Science Center. She completed a pharmacy practice residency at the Memphis Veterans Affairs Medical Center.

Rochelle Vargas, BS, earned her bachelor’s of science in business administration from the University of Phoenix. Over her 16-year tenure at UNC Health Care, she has held various positions within the department of pharmacy from Medicaid specialist to billing supervisor to her current role as a quality assurance (QA) specialist for nearly 5 years. As a QA specialist, her responsibilities include hospital and pharmacy compliance with regulatory standards.

Neelu P. Patil, PharmD, BCPS

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