During a full inspection, the DSHS licensors will evaluate the medication services systems. This evaluation includes observations, interviews, and record reviews to ensure the assisted living’s medication systems are safe and current standards are implemented. The medication system evaluation process is resident outcome-focused, with attention given to storage, delivery, and honoring residents’ rights.

The medication system evaluation typically begins with documentation review as the licensors look at sampled resident records. This record review includes but is not limited to:
  • Clearly written medication orders with directions and parameters (if necessary); indication that staff is following those orders and parameters
  • Medications taken as ordered, via initials indicated on the Medication Administration/Assistance Record (MAR)
  • Medications not taken include date and time, reason for refusal, and subsequent follow-up (i.e., reporting to the nurse, another supervisor, and/or the prescriber)
  • As-needed medications documented, with follow-up to ensure medication was effective or, if not, steps taken to advocate for the resident
  • Sample resident assessments and negotiated service agreements reviewed to ensure:
  • Resident’s abilities and preferences regarding medications are included, and match the medication services the resident receives;
  • If family assistance with medications is allowed, there is a written plan and back-up plan available and complete following WAC 388-78A-2290;
  • Residents on the EARC, EARC-SDC, and/or AL Medicaid contracts receive medication administration should they be assessed as needing this service

Observations occur both formally and informally. Informal medication system observations occur throughout the inspection. Formal observations of a medication pass occur by a RN licensor only, and only when issues are identified with potential and/or actual negative resident outcome. Observations may include but are not limited to:
  • STORAGE including following storage directions on the label; secure storage (locked med carts, locked medication storage rooms/areas); adherence to storage temperature expectations; no expired or discontinued medications; controlled substances double-locked; meds organized per route, and separated per resident. 
  • DELIVERY METHODS including documentation, proper assistance/administration methods; alterations in medications as ordered; privacy honored; resident preferences taken into consideration, residents observed taking medications. Prescriber’s orders will be compared to the medications delivered to ensure correct medications offered following standards of medication delivery.
  • PRESCRIPTIONS received and started timely
  • RESIDENT RIGHTS HONORED including the right to refuse medications; honoring residents’ choices and preferences
  • DISPOSAL including proper medication destruction (two staff for controlled substances); following best practices

Interviews may take place with medication staff, residents, and others to determine staff’s knowledge and technique, staff-resident interaction and communication during activities that include medication services, and to determine if medication assistance and administration services are within regulatory guidelines.

If there are concerns regarding medication management systems, the licensor(s) may expand the sample to include supplemental residents to determine if there is failed practice. This may include additional medication pass observations, interviews with residents, staff, and families, and reviews of the facility’s medication policies and procedures.

Because medication services systems are consistently listed in the top five citations by DSHS, it behooves the provider to develop and implement strong facility policies and procedures, training and re-training of medication staff, and internal quality assurance/performance improvement audits and processes to consistently enhance safe medication systems. If you have questions about medication management in assisted living, please email Vicki McNealley or call her at (800) 562-6170, extension 107.
For those of you working in skilled nursing facilities prior to the pandemic, you’ll remember that in the spring of 2019, the Centers for Medicare & Medicaid Services released the long-awaited revisions to Appendix Q, Guidance on Immediate Jeopardy. This “new” guidance was to enhance consistency and clarity regarding IJ citations for surveyors and for facilities. Well, now nearly three years later, IJ citations remain a focus and concern here in Washington and across the nation. The enforcement ramifications remain immense, including the sanctioned loss of nursing assistant training programs. IJ level citations can occur anywhere, even in well operated facilities.

It is important that facility administration and management understand the processes involved with IJ citations prior to being in the middle of a situation when the survey team cites an IJ. Understanding the IJ guidance will also help facilities understand the triggers to identify potential circumstances that may result in an IJ before it happens. This, in turn, prevents potential or actual serious harm, injury, impairment, or death.

Appendix Q of the State Operations Manual (SOM) provides guidance for identifying immediate jeopardy. The revisions that CMS made to the guidance create a Core Appendix Q that is used by surveyors of all provider and supplier types in determining when to cite immediate jeopardy. CMS drafted associated subparts to Appendix Q that focus on IJ concerns specifically in skilled nursing facilities.

CMS has clearly stated and directed surveyors that a determination of IJ must include three key components:
  1. Non-Compliance - the facility has failed to meet one or more federal health, safety, and/or quality regulations; AND
  2. Serious Adverse Outcome or Likely Serious Adverse Outcome – must be present. As a result of the identified noncompliance, serious injury, serious harm, serious impairment, or death has occurred, is occurring, or is likely to occur to one or more identified residents at risk; AND
  3. Need for Immediate Action – the noncompliance creates a need for immediate corrective action by the provider to prevent serious injury, serious harm, serious impairment, or death from occurring or recurring.

There are also some key definitions and clarifications made by CMS in the QSO-19-09-ALL memo and guidance.
  • Likelihood instead of potential – Core Appendix Q makes it clear that to cite immediate jeopardy in situations where residents have not already suffered serious injury, harm, impairment, or death, the nature and/or extent of the identified noncompliance creates a likelihood (reasonable expectation) that such harm will occur if not corrected, not simply the potential for that level of harm to occur.
  • Culpability was removed – Because the regulatory definitions of immediate jeopardy do not require a finding of culpability, that requirement was removed and replaced with the key component of noncompliance.
  • Psychosocial harm – Core Appendix Q includes a section instructing surveyors to consider whether noncompliance caused or made likely serious mental or psychosocial harm to residents. In situations where the psychosocial outcome to the resident may be difficult to determine or incongruent with what would be expected, the guidance instructs surveyors to use the reasonable person concept to make that determination. The reasonable person approach considers how a reasonable person in the resident’s position would be impacted by the noncompliance.
  • No automatic immediate jeopardy citations – Core Appendix Q makes it clear that each immediate jeopardy citation must be decided independently and there are no automatic immediate jeopardy citations.

Another significant change that occurred to the IJ processes in 2019 was the use of the IJ Template. The IJ Template is a document developed by CMS to assist surveyors to document the information necessary to establish each of the key components necessary to determine an IJ (outlined in above). The survey team/complaint investigator must complete the IJ Template to document evidence of each component of an IJ and use the tool to communicate the IJ to the facility.

It is critical that administrative staff responsible for the operations of the facility read the full guidance in detail, carefully review the information, and discuss with staff as appropriate. CMS also has training available for surveyors that is open to providers regarding Immediate Jeopardy determination, see CMS Education website here. (Credential required to log in.) If you have questions, please call Elena Madrid at (800) 562-6170, extension 105, or email.
303 Cleveland Avenue SE, Suite 206 | Tumwater, Washington 98501
Tel (800) 562-6170