MILBANK, SD - Federal inspectors cited St William's Care Center for multiple regulatory violations involving controlled medication storage and failure to properly investigate alleged staff misconduct with residents during a July 2024 complaint investigation.
Controlled Medication Storage Failures
The most significant violation involved the improper storage of Tramadol, a controlled pain medication. Federal inspectors found the facility was not following its own policies for securing controlled substances, creating potential risks for medication diversion and resident safety.
During interviews with medication staff on July 23, 2024, medication aide E confirmed that resident 1's Tramadol 50 mg tablets were kept in the same location as other scheduled medications and were not double-locked as required by federal regulations and facility policy.
The medication aide acknowledged awareness that Tramadol is a controlled substance but explained the facility's inconsistent practice: while PRN (as-needed) controlled medications were properly stored in double-locked drawers and counted at shift changes, scheduled controlled medications were not receiving the same security measures.
Licensed practical nurse D confirmed this practice during interviews, stating that only PRN Tramadol was stored in the double-lock box, while scheduled controlled medications like Tramadol and Clonazepam were kept with other regular medications.
Regulatory Requirements for Controlled Substances
Federal regulations require all controlled substances to be stored in separately locked compartments to prevent unauthorized access and potential diversion. This security measure protects both residents and staff by ensuring these medications remain under strict control and accountability.
The facility's own Controlled Substance-Narcotic Medication Management policy, dated July 14, 2023, explicitly states that all scheduled II-V medications must be maintained in separately locked, permanently affixed compartments of the medication cart, and all controlled substances must be counted at each shift change.
Director of nursing B acknowledged during the investigation that the facility was not following its policy, explaining that "the double-lock drawer is not big enough for all the controlled medications." She agreed that having scheduled Tramadol doses with other medications violated their current policy.
Investigation Protocol Violations
The facility also faced citations for failing to properly investigate alleged incidents involving staff interactions with residents. Administrator A confirmed awareness of reported incidents between a certified nursing assistant (CNA J) and two residents but failed to conduct thorough investigations or report the allegations to required entities.
The administrator revealed that after nurse aide M reported incidents the previous week, she only texted the director of nursing to "tell [CNA J] she has to watch her interactions." No formal investigation was initiated, and no reports were filed with state authorities as required by facility policy and state regulations.
When pressed about specific incidents, administrator A initially denied knowledge of one incident involving CNA J and resident 4. However, when inspectors provided more details, including the resident's statement that "He's a hateful person," the administrator did remember the incident.
Facility Policy Requirements
The facility's Abuse, Neglect and Misappropriation policy clearly outlines investigation procedures that were not followed. The policy requires staff to identify suspicious events, conduct thorough investigations, protect residents during investigations, and report all alleged violations to proper authorities.
Specifically, the policy mandates reporting to the South Dakota Department of Health within 2 hours for serious bodily injury incidents, or within 24 hours for other incidents. Results of investigations must be reported to appropriate agencies within 5 working days.
The administrator confirmed she had not informed other department heads about the incidents, citing an attempt to maintain confidentiality. She had not considered involving the staff development coordinator in addressing the situation, despite the facility's policy requiring comprehensive investigation and prevention measures.
Medical and Safety Implications
Improper storage of controlled medications creates multiple risks in healthcare settings. Tramadol, classified as a Schedule IV controlled substance, has potential for abuse and dependence. When not properly secured, these medications may be diverted by staff or accessed by unauthorized individuals.
Inadequate medication security also compromises accurate medication administration records. Without proper counting procedures for all controlled substances, facilities cannot ensure residents receive their prescribed medications as ordered, potentially leading to under-treatment of pain or other medical conditions.
The failure to investigate alleged staff misconduct represents another significant safety concern. Facilities are required to protect residents from potential abuse or inappropriate treatment by ensuring all reports are thoroughly investigated and appropriate corrective actions are taken.
Industry Standards and Best Practices
Healthcare facilities must maintain strict protocols for controlled substance management as part of their federal certification requirements. These standards exist to prevent medication diversion, ensure accurate administration, and protect vulnerable populations.
Best practices include regular audits of medication storage areas, comprehensive staff training on controlled substance policies, and immediate reporting of any suspected violations. Facilities should also maintain adequate storage space to accommodate all controlled medications in appropriately secured compartments.
For incident reporting and investigation, industry standards require prompt action, thorough documentation, and coordination with appropriate regulatory agencies. Facilities must balance confidentiality concerns with the need for comprehensive investigation and resident protection.
Inspection Outcomes
The July 24, 2024 inspection resulted in citations for both violations, with inspectors noting "minimal harm or potential for actual harm" affecting few residents. The facility was required to develop corrective action plans addressing both the medication storage deficiencies and investigation protocol failures.
Federal regulations require facilities to demonstrate compliance with all citation areas before continuing to participate in Medicare and Medicaid programs. The facility must show evidence of policy implementation, staff training, and ongoing monitoring to prevent future violations.
The inspection findings highlight the importance of consistent policy implementation and adequate resources to support regulatory compliance. Both violations represent systemic issues requiring administrative attention and ongoing oversight to ensure resident safety and quality care.
Full Inspection Report
The details above represent a summary of key findings. View the complete inspection report for St William's Care Center from 2024-07-24 including all violations, facility responses, and corrective action plans.
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