Finding Description
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review the facility failed to provide an adequate indication for the use and sufficient monitoring of male residents prescribed an oral contraceptive (Depo Provera) for 3 of 8 residents (R12, R14, R21) reviewed for unnecessary medications in a sample of 22.
The Findings Include:
1. R12's admitting Diagnoses Sheet dated 10/31/18 includes Schizophrenia, anxiety, bipolar, mood disorder, delusional disorder, Parkinson's, dementia, and major depressive. R12 was given a new diagnosis of other sexual dysfunction not due to a substance or known physiological condition on 05/12/23. R12's Face Sheet indicates he is his own representative.
R12's August 2023 Physician's Order Sheet (POS) includes a prescription for Depo-Provera Intramuscular Suspension 150 mg/ml (milligram/milliliter) (Medroxyprogesterone Acetate (Contraceptive) dated 05/12/23, Inject 1 milliliter intramuscularly one time a day every 90 day(s) related to other sexual dysfunction not due to a substance or known physiological condition.
R12s May 2023 Medication Administration Record (MAR) documents he received an injection of Depo-Provera on 05/15/23.
R12's Care Plan includes a focus area: (R12) demonstrates behaviors that include story fabrication, argumentative with staff, soliciting staff for money and gifts, and inappropriate interactions and comments to staff. Goal: (R12) episodes of inappropriate behavior will decrease through review date. Interventions: Make (R12) aware when behaviors are inappropriate. Monitor and report behaviors to nurse. Report abusive or aggressive behaviors to the appropriate supervisor. Date Initiated: 2/22/2019. Revision on: 04/25/2022. There is no documentation on R12's care plan indicating sexually inappropriate behavior towards other residents in the facility.
R12's most recent quarterly minimum data set (MDS) dated [DATE] indicates he is moderately cognitively impaired with a brief interview for mental status (BIMS) score of 9. R12 requires extensive one person assistance for bed mobility and transfers, requiring supervision and set up only for locomotion in his room or corridor. R12 is assessed to exhibit no physical, verbal, or behavioral manifestations of hitting, kicking, pushing, scratching, grabbing, abusing others sexually, threatening others, screaming at others, cursing at others, physical symptoms such as hitting or scratching self, pacing, rummaging, public sexual acts, disrobing in public, throwing or smearing food or bodily wastes, or verbal/vocal symptoms like screaming, or disruptive sounds.
R12's behavior tracking from July 2022 to present was reviewed - Problem: Inappropriate Sexual Behavior. Interventions: 1. Remove R12 from the situation to protect R12's safety and the rights of others. 2. Make R12 aware of behavior by educating him on appropriate behavior. 3. Distract and redirect R12 from inappropriate behavior. 4. Report behavior to Administrator, immediately. R12 is documented to have 15 documented episodes of inappropriate sexual behavior with no follow-up documentation describing the incident or who else was involved.
On 08/10/23 at 2:49 PM, R12 was sitting in the dining room at a table by himself drinking juice. R12 was asked if he had given consent to receive an injection of Depo-Provera and had no response. When asked if he had been getting a new shot, he stated, Yes, and he wasn't going to talk about that R12 then stated, I love you and I would marry you if you weren't married. R12 did not possess the mental capacity to comprehend what was being asked of him. R12 has been observed daily during this survey from 08/08/23 to 08/11/23 self-propelling in his wheelchair or walking with his walker about the facility. There were no observations of inappropriate behavior between R12 and other residents.
2. R14 admitted to this facility on 05/25/23 with diagnoses to include Alzheimer's disease, dementia, diffuse large b-cell lymphoma, extra [NAME] and solid organ sites, and an additional diagnosis dated 05/30/23 of unspecified sexual dysfunction not due to a substance or known physiological condition.
R14's August 2023 POS includes a prescription for Depo-Provera Intramuscular Suspension 150 mg/ml (Medroxyprogesterone Acetate (Contraceptive) dated 05/30/23, Inject 1 milliliter intramuscularly one time a day every 90 day(s) related to other sexual dysfunction not due to a substance or known physiological condition.
R14's May 2023 MAR documents he received an injection of Depo-Provera on 05/31/23.
R14's care plan included a focus: I currently have an alteration in my behavior status at times sexually inappropriate with staff. Goal: I will be compliant with labs and diagnostics if ordered by my doctor through the review date. This medication has a Black Box Warning resident will have no complications through review date. I will have fewer episodes of being sexually inappropriate to less than daily by review date. Intervention: 2 staff with care PRN (as needed). My behaviors will be monitored every shift and documented. I will be monitored for a change in condition and the MD (Medical Doctor) will be notified. Administer medication and treatments ordered by MD and monitor for side effects to current medication regimens. Explain all procedures to the (SPECIFY) before starting and allow the resident (X minutes) to adjust to changes. Monitor behavior episodes and attempt to determine underlying cause. Consider location, time of day, persons involved, and situations. Document behavior and potential causes. Date Initiated: 06/08/23.
R14's most recent quarterly MDS dated [DATE] indicates he is severely cognitively impaired with a BIMS score of 6. R14 requires extensive two person assistance for bed mobility and transfers, and extensive one person assist for ambulating in his room or corridor. R14 is assessed to exhibit no physical, verbal, or behavioral manifestations of hitting, kicking, pushing, scratching, grabbing, abusing others sexually, threatening others, screaming at others, cursing at others, physical symptoms such as hitting or scratching self, pacing, rummaging, public sexual acts, disrobing in public, throwing or smearing food or bodily wastes, or verbal/vocal symptoms like screaming, or disruptive sounds.
The facility was only able to provide R14's behavior tracking sheet dated 07/11/23 through 07/25/23 which indicated R14 displayed one sexually inappropriate physical behavior on 07/23/23 at 4:26 PM. R14's record did not document what this behavior was or with whom.
On 08/11/23 at 11:00 AM, R14 stated he was not receiving any type of shot or injection related to inappropriate sexual behavior, and stated he was doing just fine.
3. R21's face sheet notes R11 was admitted to the facility on [DATE]. The same face sheet lists some of R21's diagnoses as: unspecified dementia, unspecified severity, without behavioral disturbances, psychotic disturbance, mood disturbance and anxiety, other sexual dysfunction not due to a substance or known physiological condition, schizophrenia, unspecified.
R21's MDS dated [DATE] notes that R21 has a BIMS of 02 which indicates that R21 has severe cognitive impairment.
R21's Physician orders dated 8/1/23 - 8/31/23 note an order for Depo-Provera Suspension 150mg/ml Inject 1 ml intramuscularly one time a day every 90 days, with a start date of 10/13/19 according to the consent signed by V20 (Guardian).
R21's MAR documents the following dates he received a Depo-Provera injection - 09/29/22, 12/28/22, 03/28/23, and 06/26/23.
R21's care plan notes R21 has behavior symptoms associated with sexually inappropriate behavior with staff, resident, visitors. On 4/30/21 R21 grabbed a staff members breast. Some interventions listed are R21 will be redirected by staff when inappropriate touching is initiated, redirect R21 away from risky situations, speak with R21 to see what he is needing/wanting, redirect R21 to room or quiet area to calm. There is no documentation of R21's care plan including a focus area for the injection of Depo-Provera.
On 08/10/23 at 12:34 PM, when asked if V1 (Administrator) had any documentation regarding R12, R14, or R21's sexually inappropriate behavior for each date marked on the tracking sheets, he stated there was nothing really documented to describe what happened, just the code that it happened and the code for the intervention used. V1 stated he did recall the incident on 07/23/23 stating R14 asked the nurse to get in bed with him when she was passing his medication on that day. V1 stated that nurse no longer works here, but did report this to him so that he could be aware of the comment made. When asked if he had any documentation of that interaction, V1 stated he did not. V1 stated there had been no reporting of inappropriate sexual behavior towards residents that he recalled, just mainly with staff.
On 08/10/23 at 1:00 PM, V15 (Certified Nursing Assistant/CNA) stated R12, R14, or R21 have never had sexual inappropriate behavior towards her or any residents that she is aware of.
On 08/11/23 at 8:10 AM, CNA's V17, V18, and V19 stated they had not witnessed any inappropriate sexual behavior from R12, R14, or R21 towards other residents lately.
On 08/10/23 at 2:12 PM, V20 (Guardian) was asked if she had given consent for R21 to receive injections of Depo-Provera. V20 stated she vaguely remembered the facility calling in 2019 explaining it was the physician's recommendation R21 be placed on this drug. V20 stated if her memory served her correctly, R21 was reported to have gone into a female resident's room but does not remember exact details. She stated she did give verbal approval for this drug to be started due to being the physician's recommendation and was not going to question that recommendation.
On 08/10/23 at 1:34 PM, an attempt to contact V21 (Family Member/POA of R14 - Power of Attorney) was made with no success.
On 08/10/23 01:41 PM, V2 (Director of Nursing - DON) stated the physician had not ordered testosterone levels to be drawn on R12, R14, or R21. When asked about consents for the Depo-Provera injections V2 stated R12 was his own person, R14's admission packet and any consents sent to his POA (Power of Attorney) for signature had not been returned. R21's guardian had given consent in 2019.
On 08/11/23 at 9:52 AM, V22 (Primary Care Physician - PCP) was asked about R12, R14, and R21's reported behaviors that prompted his decision to initiate treatment with the Depo-Provera injections. V22 stated R21 was at another facility prior to coming to this facility in 2019. V22 stated R21 had problems with the nurses and when they came to check on him he would do basically say sexually inappropriate comments to them that escalated to touching. V22 stated as far as he was told it was just towards staff. V22 stated R12 had similar incidents reported by staff. V22 stated R14 also came from a different facility and had issues there, but from what V22 was told R14 had not really exhibited sexually inappropriate behavior since being in this facility. V22 stated he believed R14 may have had inappropriate behaviors towards other residents there and staff were complaining so it was decided to place him on the depo injections here. When asked the criteria to introduce the Depo injection to the male population, V22 stated it would be related to sexually inappropriate behaviors that don't stop with staff interventions. V22 said it was just the male behavior, and the fact that the frontal lobe is basically gone, they act without thinking, and most likely would continue. V21 stated R12, R14, and R21 cannot mentally understand or retain redirection so it just happens over and over. When asked if the resident had to be physically/sexually aggressive, violent, or have behaviors that rise to the level of rape, he stated they did not. When asked about monitoring testosterone levels, V22 stated that was not necessary because testosterone was not the issue, the issue was their mental capacity and the inability to be redirected. V22 stated these residents could be on the drug indefinitely without causing adverse issues, but he could certainly trial a discontinuation of the Depo-Provera injections and see how it goes.
The Food and Drug Administration (FDA) Highlights for Prescribing Medication (per https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020246s036lbl.pdf) documents under Indications and Usage that Depo Provera is a progestin injectable contraceptive indicated only for the prevention of pregnancy. A black box warning documents that Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible and Depo-Provera Contraceptive Injection should not be used as a long term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.