SURVEY AND REGULATORY UPDATE | March 21, 2023
Medication Errors in Assisted Living
With the high average number of daily medications taken by residents in assisted living, medication error rates can be relatively high. Combine the high number of daily meds with the fact that there is no required training for caregivers who assist with medications, and some may pause with worry. A sigh of relief comes, however, from a study out of University of Washington, published about 15 years ago, demonstrating that caregivers in assisted living made fewer medication errors than licensed nurses.  

No matter the numbers of errors or who made them, the fact remains that medication errors pose significant risk to residents. The term “medication error” is defined as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.”* With the evolution of “just culture” in health care, the views on medication errors change from blaming a specific individual or group to exploring the facility’s systems in an effort to improve all aspects of medication delivery instead; this allows the facility to improve and strengthen systems for the greater good.
 
Regardless of other terms for medication error (including medication defect, medication-related event, medication incident), there are standard expectations related to prevention as well as response.
 
*National Coordinating Council for Medication Error Reporting and Prevention

Prevention of Medication Errors
WAC 388-78A-2450 does state that “each assisted living facility must provide sufficient, trained staff persons to furnish the services and care needed by each resident consistent with his or her negotiated service agreement and maintain the assisted living free from hazards.”

Medication errors are minimized through excellent and thorough staff onboarding and ongoing competency training and evaluations. This includes licensed nurses as well as caregivers whose roles include medication management. Training on expectations, proper medication handling and delivery, prompt and complete documentation, as well as ordering, storing, and destruction all play significant parts in the prevention of medication errors. Routine and unannounced observations with just-in-time practice improvement training aid in the continuous efforts to prevent medication errors. 
 
Response to Medication Errors
WAC 388-78A-2371 outlines that any accident or incident that jeopardizes or affects a resident’s health or life must be investigated and documented. This includes determining the circumstances of the event (what happened), and prevention measures put into place to minimize recurrence.  

There are times when medication errors also need to be reported to the Complaint Resolution Unit (CRU/DSHS hotline) as well as the credentialing agency (Department of Health) of the staff member responsible for administering or assisting with the medication. While not explicitly mentioned in RCW 74.34, medication errors can certainly rise to the level of alleged or suspected resident abuse or neglect, depending on the type of medication error (commission or omission) and other factors involved.

The Medication Error Decision Tree, provided on page 23 of the DSHS “Blue Book” (Guidebook for assisted living providers to aid in facility investigations and reporting expectations) quickly allows anyone working in the assisted living facility to determine if a report to the DSHS hotline should be made. Two of the main questions to ask yourself when considering whether to report a medication error include:

  • Was there serious disregard for consequences? This question addresses the staff person directly: did the staff person assisting with or administering the medication act (or fail to act) in such a way that showed a blatant disregard for what would happen? Depending on the action or inaction, this could be construed as possible abuse or neglect.
  • Is there significant risk of harm? This question addresses the medication either given or omitted, as well as the staff involved. For example, reporting an incident where an over-the-counter Tums was missed would not rise to the level of reporting to the hotline; administering the wrong dose of insulin, however, could lead to significant harm.

Of note, any required reporting to the hotline must occur immediately (as soon as the resident is safe); that means the two questions above must be addressed upon discovery of the error in order to make an urgent reporting decision. The facility investigation, while important, can begin shortly thereafter. If a question arises on whether to report, err on the side of safety and report; your investigation can demonstrate prevention measures by which the specific medication system in question will be improved. 

Regardless of the cause of a medication-related incident, it is imperative the assisted living team look at systems to strengthen medication management efforts. By limiting the scope of an error solely to the person(s) who were involved, the facility may incur a multitude of additional burdens, including but not limited to:

  • Creating an environment where errors are hidden or covered up, rather than brought to light and addressed early
  • Disgruntled, fearful employees who lack job satisfaction
  • High staff turnover
  • Continued DSHS-issued citations with possible fines and/or conditions on the assisted living license
  • Continued medication errors, risks to residents

To mitigate these possible burdens, the facility investigator and the entire facility management and staff must embrace a learning environment where efforts are made to prevent errors from occurring, and systems (rather than just people) are looked at with an eye to strengthen. Creating a culture whereby employees are expected to perform at their best all while seeking ways to reinforce company-wide safety systems has shown to improve staff morale and resident safety.

Questions about assisted living regulations? Email Vicki McNealley or call 1 (800) 562-6170, ext. 107. 
Psychosocial Outcome Severity Guide and Citations at F600-Abuse | SNF
The Centers for Medicare & Medicaid Services (CMS) released the psychosocial outcome and severity guide (POSG) in conjunction with the Phase 2 ROP (Requirements of Participation) changes and Phase 3 ROP F-tags and guidance in QSO-22-19-NH. Before reviewing the relationship of the POSG to an abuse citation, it is important to revisit the purpose of the guide and how CMS directs the surveyors to implement it.  

  • The POSG helps surveyors determine the severity of psychosocial outcomes resulting from identified noncompliance at a specific F tag and how to apply the principles described in the POSG to cases of abuse at Tag F600 in Appendix PP. CMS emphasizes that surveyors must determine whether noncompliance exists first before determining the severity level of a deficiency. 
  • The POSG is used in conjunction with the scope and severity grid to determine the severity of outcomes to each resident. This guide is not intended to replace the current scope and severity grid. 
  • The POSG applies to any regulatory grouping, such as Quality of Life or Quality of Care, which results in, or may result in, a negative psychosocial outcome.
  • Lastly, the POSG describes how to apply the “reasonable person concept,” when the impact on the resident may not be apparent or documented.

Reasonable person concept is to assist the survey team’s assessment of the severity level of negative or potential negative psychosocial outcome that a deficiency may have had on a reasonable person in the resident’s position.

The Psychosocial Outcome Severity Guide is not found in Appendix PP of the State Operations Manual (SOM), it is found in the CMS Nursing Home Survey Resource Folder.

CMS updated the POSG to provide information to surveyors about how to investigate psychosocial outcomes to the resident. Surveyors are to obtain evidence through observation, interview, and record review. Surveyors should collect information regarding the resident’s verbal and non-verbal responses. If a psychosocial outcome is identified, the surveyors are to compare the resident’s behavior (e.g., their routine, activity, and responses to staff or to everyday situations) and mood before and after the noncompliance, and any identified history of similar incidents. 

When a surveyor cannot conduct an interview with the resident for any reason, or there are no apparent or documented changes to behavior, the surveyor should attempt to interview other individuals who are familiar with the resident’s routine or lifestyle, such as the resident’s representative, the resident’s family, Ombudsman, the resident’s direct care staff, and/or medical professionals, to assess the psychosocial impact on the resident. 

If no changes are apparent or documented, the surveyor should consider the response a “reasonable person” would exhibit in light of the triggering event. CMS describes three instances in the guide in which a surveyor should use the reasonable persons concept: 

  1. There are no apparent or documented changes to the resident’s behavior.
  2. When a resident may not be able to express their feelings, there is no discernable response, or when circumstances may not permit the direct evaluation of the resident’s psychosocial outcome.
  3. When a resident’s reaction is markedly different with the level of reaction a reasonable person in the resident’s position would have to the deficient practice.

When applying the reasonable person concept, the surveyor should consider the following in regard to the resident’s position (what degree of actual or potential harm would one expect a reasonable person in a similar situation to suffer as a result of non-compliance): 

  • The resident may consider the facility to be his/her “home,” where there is an expectation that s/he is safe, has privacy, and will be treated with respect and dignity. 
  • The resident trusts and relies on facility staff to meet his/her needs. 
  • The resident may be frail and vulnerable. 

The surveyor should document evidence that describes the resident’s actual response and the perspectives of someone familiar with the resident. In applying the reasonable person concept, it may reveal that the resident is likely to, or may potentially, suffer a greater psychosocial harm. CMS examples such things as expressions of anger, agitation, or distress that has caused aggression that can be manifested by self‐directed responses, hitting, shoving, biting, or scratching others, crying, moaning, screaming, or combative behavior that is above the resident’s baseline, fear or anxiety that may be manifested as panic, immobilization, and/or agitated behaviors, such as trembling or cowering. Which may result in an Immediate Jeopardy determination.

CMS states that the psychosocial outcome of abuse may not be apparent at the time of the survey, since it may take months or years to manifest itself and can have long‐ term effects on the resident and his/her relationship with others.

Examples of abuse that create the likelihood for serious psychosocial harm, or immediate jeopardy to a resident include, but are not limited to: 

  • Sexual assault, such as rape, unwanted sexual touching, sexual harassment, and any staff to resident physical, sexual, or mental/verbal abuse. 
  • Posting/sharing of demeaning/humiliating photos/videos, punishment such as taking away resident’s things, withholding care, resident to resident physical abuse which is likely to cause fear/harm. 

The survey team will document on the CMS-2567 when it applies the reasonable person concept in determining the psychosocial outcome(s) for a deficiency. 

SNF Questions? Email Elena Madrid, or call at 1 (800) 562-6170, ext. 105.