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Strengthening Pharmaceutical Compliance in ASCs
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February 24, 2025
Safe pharmaceutical practices in ambulatory surgery centers (ASCs) are essential to patient safety, regulatory compliance, and high standards of care.
ACHC Standard 12.00.03 stipulates that drug preparation and administration align with federal and state laws. This standard is frequently cited as a deficiency for a variety of missteps.
Common Issues: Small Corrections with Big Impact
Let’s look at three prevalent findings noted by ACHC Surveyors and what you can do today to ensure compliance with Standard 12.00.03 and other related standards.
- Don’t: Leave Medical Records Unsecured
Neglecting to secure presents significant security risks. And using pre-filled medication orders for distribution to all patients by nurses may result in incomplete patient records. Each of these issues raises liability concerns, and undocumented orders increase the risk of drug diversion and misuse.
Instead: Maintain Vigilant Record Security
Instruct your clinicians to input patient and treatment data directly into each patient’s medical record. This minimizes unauthorized access and ensures that each order is connected to a specific patient. Electronic health record (EHR) platforms should be password-protected, and paper-based medical records should be stored in locked cabinets with access limited to authorized personnel. - Don’t: Neglect Pain Management Protocols
The absence of or inconsistent use of pain management protocols can lead to variable administration of high-risk drugs such as fentanyl. When not using clinical tools offering defined criteria as the basis for treatment, ASCs risk causing potential harm to their patients.
Instead: Use Pain Management Scales
Pain scales provide criteria that allow clinicians to accurately assess patient pain and consistently administer appropriate prescriptions. For high-risk medications such as opioids, defining specific dosing parameters can help mitigate risk of overmedication. - Don’t: Ignore Gaps Between Policy and Practice
Surveyors frequently note conflicts between policies and practices in ASCs. One example is an ASC having a policy prohibiting range dosing and providers writing medication orders using such doses. A second example is a policy that prohibits the distribution of “sample drugs” to patients and practice that violates that prohibition.
Instead: Review Policies and Practices Regularly
Conduct annual reviews of policies. During these reviews, assess each policy for relevance, especially when changes are needed and when new medications or procedures are introduced. Audit practices to ensure alignment.
Do: Train and Communicate with Your ASC Staff
Teamwork between clinical and administrative staff does more than establish a positive working culture. Consistent and routine staff training on policies and protocols will help mitigate the risk of harmful medication errors. Training and feedback sessions create the kind of open communication that identifies potential barriers to compliance quickly. Surveys, meetings, and anonymous suggestion channels are additional ways for leadership to get valuable feedback.
Bringing Standard 12.00.03 to Life
Your focus on procedural care makes drug preparation and administration an essential part of every case. Successfully addressing the requirements of Standard 12.00.03 begins with policy and extends to consistent implementation, built by ongoing training and monitoring. By securing medical records, implementing consistent pain management protocols, aligning policies with practices, and fostering a culture of open communication, you can keep your ASC compliant and demonstrate your ASC’s commitment to exceptional patient care every day.
Ambulatory surgery centers that use ACHC Accreditation Standards as a framework for continuous improvement are proactive, adaptable, and successful in maintaining compliance. We’re here to help. Contact us.