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11. Drug Diversion

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									                  SUSPECTED DRUG DIVERSION
         AFH COMPLAINT/INCIDENT INVESTIGATION PROTOCOL

PURPOSE
To guide investigation of allegations of suspected drug diversion in order to determine if
failed facility practice relative to a statute(s) or regulation(s) has occurred and if the failed
practice(s) had, or has, the potential to contribute to negative resident(s) outcome(s).

IMPORTANT CONSIDERATIONS
Although the title of this Protocol refers to “drug” diversion, this Protocol is meant to also
refer to the term “medication” as well, depending on the specific C/I allegation(s) to be
investigated. Drug/medication diversion is usually a misappropriation of resident property.
As such, it represents a potential criminal act and may affect the health and/or safety of the
resident(s). If local law enforcement is, or should be involved, attempt to coordinate with
them prior to initiating the on-site investigation. Coordination may provide the RCS staff
investigator with key information.

The investigation may determine either/both drug diversion and/or drug discrepancies.
Discretion is important at all stages of the investigation, as it is imperative that the reason
for the investigation is not disclosed until the situation is thoroughly evaluated. The
approach to interviewing and observing residents, staff and providers may have to be
individualized, depending on whether or not they have knowledge of, or are suspected of,
being involved in drug/medication diversion incidents.

The investigator is to determine if failed practice had, or has, the potential to contribute to
negative resident(s) outcome(s). The focus of the investigation is to be on determining if
the AFH provider’s response met regulatory requirements, ensured the resident(s)
was/were protected, the resident(s)’ medical and medication needs were addressed, and
the AFH has drug/medication diversion prevention systems in place.

AUTHORITY
The following is a list of rules and regulations that pertain to administration and
management of drugs/medications. As indicated by the reported concern(s), review these
rules and regulations and others that may apply.

Chapter 69.41 RCW – Legend Drugs – Prescription Drugs
Chapter 70.128 RCW – Adult Family Homes
Chapter 70.129 RCW – Long-Term Care Resident Rights
Chapter 74.34 RCW - Abuse of Vulnerable Adults
WAC 246-840-910 through 246-840-980: RN Delegation
WAC 246-888 – Medication Assistance
WAC 388-76-540 – Definitions
WAC 388-76-61000 through 61080 – Resident Assessment
WAC 388-76-61500 through 61560 - Negotiated Care Plan
WAC 388-76-620 – Provision of Services and Care
WAC 388-76-64010 through 64055 – Resident Medications
WAC 388-76-655 - General Management and Administration



AFH Suspected Drug Diversion                     April 2007                            Page 1 of 9
WAC 388-76-675(1)(3)(5) – Reporting Requirements
Chapter 388-112 WAC – Residential Long-Term Care Services

I. OFF-SITE PREPARATION

Review pertinent section(s) of RCS C/I Guidance. In addition:
 For concerns regarding abuse, neglect or medication misappropriation, review the
   Abuse, Neglect, Financial Exploitation/Misappropriation/Missing Items and/or Medication
   Management/Administration Protocols for sections relevant to off-site preparation.

A. Identify/Clarify Issues
   If information reveals the concern is not within RCS’ statutory jurisdiction, refer to
   MB R07-010 – Operational Principle and Procedure for CRU Complaint/Incident Referral
   Processing in Field Offices, for guidance and actions to take.

   1. Review the CRU Intake Form
   2. Contact Complainant
      a. Incidents: Do not interview Facility Reporter prior to going on-site.
      b. Complaints: Do interview Complainant. Explain their confidentiality will be
         respected and that their name would only be disclosed in a legal hearing.

   As each situation is unique, the information in the Complaint Intake Routing Form needs
   to be carefully reviewed and then, a decision made whether it is prudent to interview the
   complainant prior to the on-site investigation. This applies to both public and mandated
   reporter complaints. Consult with your Field Manager as often as necessary, especially
   for allegations of suspected drug diversion.

   Questions to consider:
    What are their drug diversion concerns?
    What medications are involved and when are they given?
    How did they become aware of the issue(s)?
    When did it happen? Has it happened before?
    Did they tell anyone? If so, whom?
    Has anything been done about it?
    Is it still a problem? Does anyone else share your same concerns?
    How did it affect the resident(s)?
    Have other residents been affected?
    Is the resident able to describe what happened/identified alleged perpetrator?
    If not, who could provide additional information?
    Is there a particular staff member or other resident/family member/visitor they are
     concerned about?
    When might that staff person be on duty?
    Do they have other concern(s)?

B. Preliminary RCW/WAC Selection:
   As part of the off-site investigation plan, determine the number of allegation(s) to be
   investigated, as identified on the Complaint Intake Routing Form from CRU and from



AFH Suspected Drug Diversion                  April 2007                         Page 2 of 9
   any additional information obtained prior to going on-site. Identify in advance the likely
   applicable statutes and/or regulations that address the allegation(s) to be investigated.
   If the investigation determines additional unalleged failed facility practice(s), go back
   and determine additional RCW/WACs applicable for these citations, as well.

C. Review History
   Review RCS C/I Guidance, Section II.

D. Plan Approach to Investigation
   1. Special Considerations
      Review pertinent section(s) of RCS C/I Guidance. In addition:
       Focus your investigation on the practices related to safeguarding resident
         medications at all times and supporting proper medication assistance/
         administration practices.

       Timing Initial Visits
        When medications are likely to be given, if known.
        When the alleged perpetrator might still be present/on duty.
        In coordination with outside resources, such as local law enforcement or with
          inside resources, such as another RCS staff or a Field Manager.

       Remember: The issue to be resolved in nearly all C/I Investigations regarding
       alleged medication/drug diversion is one of medication verification and reconciliation
       for the named/involved resident(s). RCS staff does not touch, nor do you personally
       count resident medications, regardless of your professional discipline.

       Note: If you believe the need for medication verification and reconciliation is
       essential to your C/I investigation, consult by phone with your Field Manager and
       together decide how such a process will be undertaken by RCS RN staff during the
       visit in progress. Take time to thoroughly document these C/I investigative
       strategies, findings and consultation(s) with your Field Manager.

   2. Observation Planning
      Review pertinent section(s) of RCS C/I Guidance. In addition, conduct a sufficient
      tour of the licensed areas of the AFH with a focus on all the residents and the
      provider’s practices to keep medications safe/secure in all instances/settings.
      Observe:

 Staff/Alleged Perpetrator          Medication Security            For Potential Delivery
                                                                           Issues
Observe staff perform and       Where are resident(s)’          How do medications get to the
document medication pass        medications kept?               AFH from the resident(s)’
and/or medication assistance.                                   pharmacy?
* Named resident(s)
* Named staff
* Medication(s) of concern,
  whether they are over-the
  counter (OTC), legend,
  narcotics, etc.


AFH Suspected Drug Diversion                  April 2007                          Page 3 of 9
  Staff/Alleged Perpetrator            Medication Security              For Potential Delivery
                                                                                Issues
How do they prepare,              Are all prescribed and OTC        How often are they delivered
provide and document              medications kept in locked        by such a pharmacy to the
medication pass/assistance?       storage?                          AFH or are they only picked
                                                                    up by provider and/or a
                                                                    resident’s family?


How do they validate              Where are the keys kept for       When medication organizers
resident(s) actually take their   medication locked storage         are used, refer to WAC 388-
medication(s), as ordered?        areas?                            76-64050 to assure the
                                                                    provider’s compliance with
How do they handle and            Who all has access to             these requirements.
dispose of:                       medications/keys,
                                  administers medication
* Refused medications?            and/or uses the keys?
* Medications when a
  resident dies or is formally    Note type of lock(s) used for
  discharged to another           medication security?
  setting?
                                  Are any medication(s) left
                                  unattended/unsecured?
                                  Document any/all findings.

                                  Are there resident(s) who
                                  store medication(s) in their
                                  room(s)?
                                  * Are there drugs of concern
                                     that are kept in resident(s)
                                     rooms?
                                  * How are they kept secured
                                     from unauthorized
                                     person(s), such as a
                                     resident with a tendency
                                     to wander?

                                  Look for evidence of
                                  unauthorized person(s) who
                                  could gain access to the
                                  medications, such as other
Intentionally left blank          resident(s), family, visitor(s)
                                  and staff.                        Intentionally left blank

                                  Are all prescribed and OTC
                                  medication(s) stored in
                                  original containers with
                                  original and legible label(s)?



AFH Suspected Drug Diversion                      April 2007                          Page 4 of 9
  Staff/Alleged Perpetrator         Medication Security                For Potential Delivery
                                                                              Issues
                               * If there is any suspect drug
                                  diversions/discrepancies,
                                  then follow the established
                                  investigative strategy for
                                  RCS RN staff to do the tasks
                                  of medication verification and
                                  reconciliation.

Intentionally left blank.      If/as applicable and with the       Intentionally left blank.
                               provider handling all
                               drugs/medication(s), validate
                               the correct medication, such as
                               tablet markings/trademarks,
                               etc:

                               * Is the container labeled
                                  legibly and correctly?

                               * Does it match the
                                 prescriber’s most current
                                 orders?

                               * For liquid drugs, such as
                                 elixirs, observe for
                                 appropriate color/
                                 consistency, given any
                                 allegations of possible
                                 diversion and replacement
                                 with water or other liquid.

                               * Pre-packaged medications
                                 – look for evidence of
                                 tampering, such as taping
                                 of medication back into a
                                 blister pack.

                               * Have the alleged
                                 perpetrator, if still on the
                                 job, describe what is done
                                 with resident medications
                                 when they are refused or
                                 when a resident dies or is
                                 discharged. If that
                                 person cannot be
                                 observed for a valid
                                 reason, then interview
                                 other staff on what they
                                 do, or would do, with
                                 medications in these
                                 similar circumstances.




AFH Suspected Drug Diversion                   April 2007                             Page 5 of 9
   3. Interview Planning
       Use this opportunity to observe the resident(s) for the effectiveness of medications,
       potential side effects and/or the desired positive effects (such as short-acting pain
       medication relief), as well as focusing on medication(s) of concern:

   Resident(s)/Family           Providers/Caregiver/Staff            Provider Specific
Who helps you with your        Are there concerns about       If the provider is not aware
medications, if anyone         medication storage, handling   there is an alleged drug
does?                          or documentation?              diversion problem, explain
                                                              why you are there and what
                                                              you have observed, when the
                                                              time is appropriate.

How often do you take          What are they and what         Ask how their AFH caregivers
medications?                   medications are involved?      are trained to give
                                                              medications – look at training
                                                              materials, if available.

What can you tell me about When did it start?                 Ask what is the provider’s
your medications?                                             system for handling controlled
                                                              and non-controlled
                                                              medications?


Do your medications seem       How long has this been         If medications were missed or
to be helping?                 going on and what has been     a drug diversion suspected/
                               done about it?                 was confirmed, who was
If no, have you told                                          notified (family, prescriber,
anyone? Who/when?                                             pharmacy) and when?
What has been done about
this?

Do you get your                Is it still a problem?         If police were notified:
medications when you ask
for them, if you receive                                      * Which local law
assistance from staff?                                          enforcement agency did/
                                                                did not respond to the call
                                                                and when?

Are they working? Which        Who knows about it?            * What is the officer’s name?
one(s) are not working?
                                                              * Police case number?
If no, how long has this
been going on for each                                        * What actions were taken?
medication named?




AFH Suspected Drug Diversion                    April 2007                        Page 6 of 9
   Resident(s)/Family           Providers/Caregiver/Staff             Provider Specific
How has this affected you?     Did it affect one or more of
Did you tell anyone? (who,     the resident(s)?
what, when, where, why)
                                                                Intentionally left blank.
What has been done about       What was done to protect the
it for you?                    resident(s), ensure their
                               medical/medication needs
                               are met and prevent a
                               recurrence of medications
                               not being available as
                               needed?

Do you have concerns           Are there concerns about
about how frequently your      AFH’s staff storage, handling
medications(s) need to be      and documentation of
refilled?                      medications?

Have you ever been told        If yes, what are they?
that your medication needs
to be “borrowed” for
another resident?



   3. Record Review Planning
      Make preliminary decisions regarding which records need to be reviewed and
      adjust/expand as needed, based on information obtained on-site.

II. ON-SITE ACTIVITIES

Review pertinent section(s) of RCS C/I Guidance. Follow your off-site plan for on-site
activities. Based on information obtained during the on-site investigation, expand your
observations and interviews, as needed. In addition, add to the Record Review section:

Record Reviews
Confined to the issues:

             Resident(s) Records                            Provider/Staff Records
 Review most current assessment and             Review and document:
 negotiated care plan for pertinent medical     * Personnel files for alleged staff or if no
 diagnoses and treatment plans associated         alleged perpetrator, but drug diversion
 with medications.                                alleged: Consider review of a random
                                                  sample of personnel files to assure
                                                  facility compliance with regulations
                                                  related to criminal history background
                                                  checks and pertinent orientation and
                                                  training.



AFH Suspected Drug Diversion                   April 2007                            Page 7 of 9
             Resident(s) Records                            Provider/Staff Records
 Review and document:                            AFH’s practice addressing the disposition of
 * Current prescriber’s order(s)                 resident prescribed medications that are
 * Types/dosages/method of delivery/             unused, left over or remaining after the
   special instructions for any medications.     resident leaves the AFH. Refer to WAC 388-
 * Indications for use based on medical          76-64010(7).
   diagnoses that are most pertinent.
 * Notes in record that support the
   allegation(s) of suspected drug diversion.
 * Once provider became or was made
   aware of the issue, what was done to
   meet the resident’s medical/medication
   needs?

 Daily Medication Log:                           AFH’s practice addressing RN Delegation of
 * Accurate/missing/altered entries?             tasks related to medications, if relevant.
 * Missing pages?
 * Timely entries, per regulation?
 * Orders transcribed correctly?
 * Trends and patterns evident in daily
   medication log?
 * Medication refusals? What is done/who
   is notified when this happens?
 * Desired effect known and effect
   documented?
 * Who’s administering the medications?
 * Who is providing medication assistance?
 * Are they trained?

 Residents Able to Independently Take            AFH’s practice related to assessment of
 Medications:                                    residents and the degree of assistance they
 * Determine if the resident’s level of          need to take medications.
   function is supported by the current
   assessment and negotiated care plan
   and that it concurs with resident/staff
   interviews and observations during
   investigation.

 Residents Who Self-Administer                   Documentation of evidence of provider’s
 Medications with Assistance:                    follow-up, if alleged drug diversion and/or
 * Determine if the resident’s level of          evidence of drug discrepancies found
   function is supported by the current          independently or reported to provider by
   assessment and negotiated care plan           someone else.
   and that it concurs with resident/staff
   interviews and observations during
   investigation.


Review and Analyze Data
Consider interviewing pharmacist/pharmacy staff. Discuss strategy with your Field Manager.


AFH Suspected Drug Diversion                    April 2007                         Page 8 of 9
   What processes do they use for mailing/delivering medications to this AFH?
   How do they know the home receives the medications shipped to the AFH?
   What is their refill process for pertinent drugs?
   Have they had concerns about resident medication handling at this AFH? If yes, get
    further details.
   Has the family or any one else raised any issues about the resident’s medications?

Do your investigation results answer these and other pertinent questions?

   Is the provider in compliance with rules and regulations governing prevention of drug
    diversion?
   Is the provider in compliance with rules and regulations governing management of
    resident prescribed and OTC medications?
   Did the provider take appropriate action in response to allegations of suspected drug
    diversion and/or drug count discrepancies?
   Did the provider follow-up, protect, report (if required) to law enforcement, APS, CRU
    hotline? If yes, what agency/case number?
   Reimburse or replace if/as appropriate, missing resident medications?
   Intervene to prevent recurrence? What specific action(s) has been done?
   Are there trends or patterns related to allegations of drug diversion and/or discovered
    drug discrepancies?
   Is provider in compliance with employee screening requirements?
   Did provider take appropriate security measures to protect resident medications?
   If RN delegation was involved, is the provider in compliance with these rules and
    regulations?
   Do a brief review of the “Key Triggers” documents.

Talk to your Field Manager when applicable prior to leaving the facility to determine if any
additional data may need to be collected and analyzed.

Status Report/Exit Conference:
Use this opportunity to explain preliminary findings and identified deficiencies to the provider
or provider representative to provide them with an opportunity to ask questions and present
additional information. Ensure provider or provider representative is aware of resident
issues that need immediate attention. See page 21 of RCS C/I Guidance for details of this
last task to be done prior to exit from the home or the last day of on-site data collection.

III. OFF-SITE ACTIVITIES & FINAL DETERMINATION

Review pertinent section(s) of RCS C/I Guidance. In addition, complete the following tasks:

    1. Final determination of failed facility practice with regulation(s).
    2. Inform provider of final outcome of investigation.
    3. Complete a Statement of Deficiency and related enforcement activities (if
       applicable).
    4. Make necessary follow-up referrals to the CRU if/as applicable.




AFH Suspected Drug Diversion                   April 2007                          Page 9 of 9
Intentionally left blank

								
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